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MS211600 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background —Creatine kinase (CK)-MB elevation after percutaneous coronary intervention ( PCI ) has been associated with subsequent cardiac death . The patients at risk , the timing of risk , and potential treatment implication s are uncertain . Methods and Results —Eight thous and , four hundred nine consecutive non– acute myocardial infa rct ion patients with successful PCI and no emergency surgery or Q-wave myocardial infa rct ion were followed for 38±25 months ; 1446 ( 17.2 % ) had post-PCI CK-MB above normal on routine ascertainment . Patients were prospect ively stratified into those with CK-MB 1 to 5 × or CK-MB > 5 × normal . No patient with CK-MB 1 to 5 × normal died during the first week after PCI , and excess risk of early death for patients with CK-MB elevation occurred primarily in the first 3 to 4 months . The actuarial 4-month risk of death was 8.9 % , 1.9 % , and 1.2 % for patients with CK-MB > 5 × , CK-MB 1 to 5 × , and CK-MB ≤1 × normal ( P < 0.001 ) . Death within 4 months was independently correlated with the degree of CK-MB elevation , creatinine ≥2 mg% , post-PCI C-reactive protein , low ejection fraction , age , and congestive heart failure class ( P < 0.01 for all ) . In a matched subset analysis , incomplete revascularization ( P < 0.001 ) , congestive heart failure class ( P = 0.005 ) , and no statin treatment at hospital discharge ( P = 0.009 ) were associated with death . Conclusions — Patients with CK-MB elevation after PCI are at excess risk of death for 3 to 4 months , although prolonging hospitalization for CK-MB 1 to 5 × is unlikely to modify risk . CK-MB > 5 × normal , incomplete revascularization , elevated C-reactive protein , heart failure , the elderly , and hospital discharge without on statin therapy increases risk . Several of these factors suggest that inflammation may play a part in the excess risk of death Background The clinical significance of myocardial infa rct ion related to treatment with percutaneous coronary intervention ( PCI ) has been subject of great discussion . This subject has been studied for many years using different definitions of peri-procedural myocardial infa rct ion and different biomarkers , the results have varied greatly depending on methods and time of the study . This study was to determine the incidence and prognostic significance of elevated cardiac biomarkers after elective PCI in patients with stable angina pectoris using the current cut-off set by the Third Universal Definition of Myocardial Infa rct ion and current biomarkers . Methods We performed a historical prospect i ve follow-up study of all patients with stable angina pectoris who underwent elective PCI at Aalborg University Hospital , Denmark from January 1st 2000 to December 31st 2012 . We stratified patients according to peak post-PCI troponin T ( cTnT ) and Creatine Kinase MB mass ( CK-MBmass ) . Results Follow-up for time to all-cause mortality was mean 5.8 years and total 15,891 years and mean 3.7 years and total 10,160 years for the combined endpoint of all-cause mortality and new onset heart failure . During the follow up period 399 of 2760 patients died ( 14.5 % ) and 1095 ( 39.7 % ) suffered the combined endpoint . Post-PCI concentration of cTnT and CK-MBmass was elevated above the defined cut-off in 419 patients ( 15.2 % ) and 113 patients ( 4.1 % ) respectively . There was no statistically significant difference between the groups in stratified analysis of the hazard rates by time regarding all-cause mortality for cTnT nor CK-MBmass . Regarding the combined endpoint the results were ambiguous . The results were unchanged in multivariable analyses that included age and gender . Conclusion The incidence of elevated biomarkers after elective PCI in patients with stable angina pectoris using the defined cut-off ( > 5 x URL ) was 15.2 % using cTnT and 4.1 % using CK-MBmass . The independent prognostic value for both cardiac biomarkers of any cut-off showed no statistical significance for all-cause mortality , whereas the combined endpoint ( all-cause mortality or new-onset heart failure ) were ambiguous in both short- and long-term follow-up OBJECTIVES We examined the relations of elevated creatine kinase ( CK ) and its myocardial b and isoenzyme ( CK-MB ) to clinical outcomes after percutaneous coronary intervention ( PCI ) in patients enrolled in Integrilin ( eptifibatide ) to Minimize Platelet Aggregation and Coronary Thrombosis-II ( trial ) ( IMPACT-II ) , a trial of the platelet glycoprotein IIb/IIIa inhibitor eptifibatide . BACKGROUND Elevation of cardiac enzymes often occurs after PCI , but its clinical implication s are uncertain . METHODS Patients undergoing elective , scheduled PCI for any indication were analyzed . Parallel analyses investigated CK ( n=3,535 ) and CK-MB ( n=2,341 ) levels after PCI ( within 4 to 20 h ) . Clinical outcomes at 30 days and 6 months were stratified by postprocedure CK and CK-MB ( multiple of the site 's upper normal limit ) . RESULTS Overall , 1,779 patients ( 76 % ) had no CK-MB elevation ; CK-MB levels were elevated to 1 to 3 times the upper normal limit in 323 patients ( 13.8 % ) , to 3 to 5 times normal in 84 ( 3.6 % ) , to 5 to 10 times normal in 86 ( 3.7 % ) , and to > 10 times normal in 69 patients ( 2.9 % ) . Elevated CK-MB was associated with an increased risk of death , reinfa rct ion , or emergency revascularization at 30 days , and of death , reinfa rct ion , or surgical revascularization at 6 months . Elevated total CK to above three times normal was less frequent , but its prognostic significance paralleled that seen for CK-MB . The degree of risk correlated with the rise in CK or CK-MB , even for patients with successful procedures not complicated by abrupt closure . CONCLUSIONS Elevations in cardiac enzymes , including small increases ( between one and three times normal ) often not considered an infa rct ion , are associated with an increased risk for short-term adverse clinical outcomes after successful or unsuccessful PCI Background — Creatine kinase-MB ( CK-MB ) elevation after percutaneous coronary intervention ( PCI ) has been associated with increased risk for mortality . Although most studies have defined periprocedural myocardial infa rct ion ( pMI ) as an elevation in CK-MB > 3 × upper limit of normal ( ULN ) , use of different CK-MB assays and variation in site-specific definitions of the ULN may limit the value of such relative thresholds . Methods and Results — We used data from the multicenter Evaluation of Drug-Eluting Stents and Ischemic Events ( EVENT ) registry to examine the impact of variations in site-specific thresholds for CK-MB elevation on the incidence of pMI as well as the relationship between absolute peak levels of CK-MB after PCI and 1-year mortality . The study cohort consisted of 6347 patients who underwent nonemergent PCI and had normal CK-MB at baseline . Across the 59 study centers , the ULN for CK-MB ranged from 2.6 to 10.4 ng/mL ( median , 5.0 ng/mL ) , and there was an inverse relationship between the site-specific ULN and the incidence of pMI ( defined as CK-MB elevation > 3 × ULN ) . Although any postprocedure elevation of CK-MB was associated with an adverse prognosis , in categorical analyses , only CK-MB ≥50 ng/mL was independently associated with increased 1-year mortality ( hazard ratio , 4.71 ; 95 % confidence interval , 2.42 to 9.13 ; P<0.001 ) . Spline analysis using peak CK-MB as a continuous variable suggested a grade d , nonlinear relationship with 1-year mortality , with an inflection point at ≈30 ng/mL. Conclusions — Among unselected patients undergoing PCI , there is a grade d relationship between CK-MB elevation after PCI and 1-year mortality that is particularly strong for large CK-MB elevations ( > 30 to 50 ng/mL ) . Future studies that include pMI as a clinical end point should consider using a core laboratory to assess CK-MB ( to ensure consistency ) and raising the threshold for defining pMI above current levels ( to enhance clinical relevance ) Background —Aggressive platelet inhibition is crucial to reduce myocardial injury and early cardiac events after coronary intervention . Although observational data have suggested that pretreatment with a high loading dose of clopidogrel may be more effective than a conventional dose , this hypothesis has never been tested in a r and omized trial . Methods and Results —A total of 255 patients scheduled to undergo percutaneous coronary intervention were r and omized to a 600-mg ( n=126 ) or 300-mg ( n=129 ) loading regimen of clopidogrel given 4 to 8 hours before the procedure . Creatine kinase MB , troponin I , and myoglobin levels were measured at baseline and at 8 and 24 hours after intervention . The primary end point was the 30-day occurrence of death , myocardial infa rct ion ( MI ) , or target vessel revascularization . The primary end point occurred in 4 % of patients in the high loading dose versus 12 % of those in the conventional loading dose group ( P=0.041 ) and was due entirely to periprocedural MI . Peak values of all markers were significantly lower in patients treated with the 600-mg regimen ( P≤0.038 ) . Safety end points were similar in the 2 arms . At multivariable analysis , the high loading regimen was associated with a 50 % risk reduction of MI ( OR 0.48 , 95 % CI 0.15 to 0.97 , P=0.044 ) . An incremental benefit was observed in patients r and omized to the 600-mg dose who were receiving statins , with an 80 % risk reduction . Conclusions —Pretreatment with a 600-mg loading dose of clopidogrel 4 to 8 hours before the procedure is safe and , as compared with the conventional 300-mg dose , significantly reduced periprocedural MI in patients undergoing percutaneous coronary intervention . These results may influence practice patterns with regard to antiplatelet therapy before percutaneous revascularization OBJECTIVES Our aim was to examine the prognostic importance of hemorrhagic and ischemic complications after percutaneous coronary intervention ( PCI ) in unselected patients . BACKGROUND In r and omized trials of PCI , major bleeding and periprocedural myocardial infa rct ion ( pMI ) have been associated with increased mortality . Whether similar associations exist among un-selected PCI patients is unknown . METHODS We used data from the EVENT ( Evaluation of Drug Eluting Stents and Ischemic Events ) registry-a multicenter registry of unselected patients undergoing PCI-to examine the association between both in-hospital bleeding and pMI and 1-year mortality . Cardiac enzyme levels were assessed in all patients , and pMI was defined as a peak creatine kinase-MB value > or=3x the upper limit of normal . Post-PCI bleeding was classified by Thrombolysis In Myocardial Infa rct ion criteria . RESULTS After excluding patients with elevated pre-PCI creatine kinase-MB values and ST-segment elevation myocardial infa rct ion at presentation ( n = 1,626 ) , a total of 5,961 patients were available for evaluation . Rates of post-PCI bleeding and pMI were 3.0 % and 7.1 % , respectively ; 1-year all-cause mortality was 2.8 % . After multivariable adjustment , both post-PCI bleeding ( adjusted hazard ratio [ HR ] : 3.83 , 95 % confidence interval : 2.48 to 5.90 , p < 0.001 ) and pMI ( adjusted HR : 1.84 , 95 % confidence interval : 1.17 to 2.89 , p = 0.009 ) were independently associated with 1-year mortality . Time period-specific analyses demonstrated that the adjusted HR for bleeding was similar for 30-day mortality and mortality between 1 month and 1 year , while the adjusted HR for pMI was greater for 30-day mortality as compared with mortality between 1 month and 1 year . CONCLUSIONS Among unselected PCI patients , both post-PCI bleeding and pMI are independently associated with increased 1-year mortality . Continued efforts to reduce these complications after PCI are warranted Background —Cardiac troponin detected by new-generation , highly sensitive assays predicts clinical outcomes among patients with stable coronary artery disease ( SCAD ) treated medically . The prognostic value of baseline high-sensitivity cardiac troponin T ( hs-cTnT ) elevation in SCAD patients undergoing elective
Output:
| Conclusion The occurrence of periprocedural myocardial infa rct ion after an elective percutaneous coronary intervention in patients with stable angina pectoris is associated with a statistically significant increase in subsequent all-cause mortality and cardiac mortality |
MS211601 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background : The adequacy of exposure of purine analogs as measured by 6-thioguanine nucleotides concentrations in the setting of combination therapy remains poorly understood . The aim of this study was to investigate the relationship between the mean corpuscular volume ( MCV ) value ( as a surrogate marker of 6-thioguanine nucleotides concentration ) and Crohn 's disease outcomes in the setting of combination therapy with infliximab . Methods : The SONIC trial was a r and omized controlled trial comparing infliximab to azathioprine and to infliximab plus azathioprine in 508 Crohn 's disease patients . An increase of at least 7 femtoliter ( fL ) of the MCV ( & Dgr;MCV ) was used for statistical analysis . Results : At week 26 , the mean increase of MCV was similar among patients treated with azathioprine alone ( mean of 7.9 fL ) or in combination with infliximab ( mean of 8.5 fL ) . In the azathioprine group , 63.6 % of patients with & Dgr;MCV > 7 were in steroid-free clinical remission at week 26 as compared with 33.3 % of patients without & Dgr;MCV > 7 ( P = 0.0046 ) . In the combination therapy group , & Dgr;MCV above 7 was associated with mucosal healing ( 75.0 % for & Dgr;MCV > 7 versus 47.1 % for & Dgr;MCV < 7 , P = 0.0172 ) but not with steroid-free clinical remission . Patients with a & Dgr;MCV above 7 were more likely to have infliximab trough level above 3 & mgr;g/mL at week 30 ( 68.4 % versus 38.8 % for & Dgr;MCV < 7 , P = 0.0032 ) . Conclusions : These results suggest that & Dgr;MCV above 7 ( which is a surrogate for a higher 6-thioguanine nucleotides concentration ) leads to improved Crohn 's disease outcomes , even when combined with infliximab . It also suggests the possibility that a lower azathioprine exposure might be less effective in combination therapy UNLABELLED RATIONALE , AIMS & OBJECTIVE : Tools for the assessment of the quality of research studies tend to be specific to a particular research design ( e.g. r and omized controlled trials , or qualitative interviews ) . This makes it difficult to assess the quality of a body of research that addresses the same or a similar research question but using different approaches . The aim of this paper is to describe the development and preliminary evaluation of a quality assessment tool that can be applied to a method ologically diverse set of research articles . METHODS The 16-item quality assessment tool ( QATSDD ) was assessed to determine its reliability and validity when used by health services research ers in the disciplines of psychology , sociology and nursing . Qualitative feedback was also gathered from mixed- methods health research ers regarding the comprehension , content , perceived value and usability of the tool . RESULTS Reference to existing widely used quality assessment tools and experts in systematic review confirmed that the components of the tool represented the construct of ' good research technique ' being assessed . Face validity was subsequently established through feedback from a sample of nine health research ers . Inter-rater reliability was established through substantial agreement between three review ers when applying the tool to a set of three research papers ( κ = 71.5 % ) , and good to substantial agreement between their scores at time 1 and after a 6-week interval at time 2 confirmed test-retest reliability . CONCLUSIONS The QATSDD shows good reliability and validity for use in the quality assessment of a diversity of studies , and may be an extremely useful tool for review ers to st and ardize and increase the rigour of their assessment s in review s of the published papers which include qualitative and quantitative work BACKGROUND & AIMS Genetic polymorphism in thiopurine methyltransferase ( TPMT ) activity may influence clinical responsiveness to azathioprine ( AZA ) therapy . Our aim was to determine if the measurement of erythrocyte TPMT enzyme activity could be used to optimize clinical responsiveness to AZA therapy in patients with inflammatory bowel disease ( IBD ) . METHODS A total of 142 consecutive patients were studied . Forty-one patients ( 32 with Crohn 's disease [ CD ] and 9 with ulcerative colitis [ UC ] ) were enrolled in a 4-month prospect i ve nonr and omized study with AZA , and 101 ( 65 with CD and 36 with UC ) were on either maintenance AZA or 6-mercaptopurine ( 6-MP ) . Erythrocyte TPMT activity and AZA metabolite levels were measured blinded to the clinical response . RESULTS The response rate after 4 months of continuous AZA therapy was 69 % ( 9/13 ) in those patients with below-average ( < /=12 U/mL blood ) TPMT activity , and 29 % ( 8/27 ) in patients with enzyme activity levels > 12 U/mL blood ( P < 0.001 ) . Patients with TPMT activity < /=12 achieved a mean ( SEM ) erythrocyte 6-thioguanine ribonucleotide ( 6-TGn ) level of 394 + /- 29 pmol/8 x 10(8 ) red blood cells ( RBCs ) ; higher than in patients with TPMT activity > 12 ( 218 + /- 28 ) , despite similar mean ( 1.6 mg/kg/day ) dosages of AZA ( P < 0.001 ) . By multivariate logistic regression analysis , patients with a TPMT level < 15.3 U/mL blood were 6.2 times more likely to respond to AZA therapy . A 6-TGn level of > 292 pmol/8 x 10(8 ) RBCs was associated with a positive predictive value of clinical response of 85.7 % . CONCLUSIONS Patients with higher than average TPMT activity ( > 12 ) may remain refractory to conventional dosages of AZA , and may require high ( > 292 ) 6-TGn levels . Prospect i ve , r and omized , controlled trials are needed to determine whether prior TPMT phenotype testing can be used to adjust the dose of AZA effectively to improve clinical response time and rate Background : Metabolite monitoring and response predictors to azathioprine ( AZA ) in pediatric inflammatory bowel disease ( IBD ) are debatable . In an attempt to optimize thiopurine therapy and underst and the mechanism of action of thiopurines , we correlated metabolites and other factors with AZA efficacy in children with IBD . Methods : Data from 86 children with IBD with 440 metabolite measurements were retrospectively analyzed using multilevel logistic regression analyses . A therapeutic response was defined as a pediatric Crohn 's disease activity index ⩽10 for Crohn 's disease or a pediatric ulcerative colitis activity index ⩽10 for ulcerative colitis without any treatment with steroids , antitumor necrosis factor , other immunomodulators , or exclusive enteral nutrition . Results : The 6-thioguanine nucleotide levels > 250 pmol per 8 × 108 red blood cells correlated with a higher response ( odds ratio , 4.14 ; 95 % confidence interval , 1.49–11.46 , P = 0.007 ) , whereas 6-methyl-mercaptopurine and 6-methyl-mercaptopurine:6-thioguanine nucleotide ratio showed no correlation . Other novel response predictors in children with IBD were relative leukopenia ( odds ratio , 14.01 ; 95 % confidence interval , 3.77–52.10 ; P < 0.001 ) and the absence of lymphopenia ( odds ratio , 3.71 ; 95 % confidence interval , 1.26–10.89 ; P = 0.017 ) . Lower thiopurine methyltransferase activity ( P = 0.015 ) , lower platelet count ( P = 0.020 ) , and higher aspartate aminotransferase level ( P = 0.009 ) also predicted therapeutic response . Age , gender , patient adherence , the duration of AZA therapy , IBD type , erythrocyte count , and erythrocyte sedimentation rate did not predict efficacy . The high interindividual variability accounting for 57.7 % of variance in therapeutic response was observed . Conclusions : The significant 6-thioguanine nucleotide level – response relationship may support metabolite monitoring to improve thiopurine efficacy in pediatric IBD . The reported response predictors may be helpful for treatment optimization in AZA-treated children with IBD , but should be proved in prospect i ve studies Abstract Objective : It remains controversial whether 6-thioguanine nucleotide (6-TGN)-based dose adjusting can be beneficial in azathioprine ( AZA ) therapy . This study is design ed to assess the role of 6-TGN concentrations in maintaining clinical remission in Chinese patients with Crohn ’s disease ( CD ) . Material and method : We performed a prospect i ve observational study and collected data of CD patients in the First Affiliated Hospital of Anhui Medical University from June 2013 to April 2014 . Demographic material , CD activity index , 6-TGN concentration , and laboratory tests were recorded at baseline and at each visit . In addition , 6-TGN was measured when drug adverse effects occurred . All patients achieved maintenance stage were administered a stable AZA dose at least 3 months before enrollment and were followed up at least 12 months . Thiopurine S-methyltransferase ( TPMT ) genotype was measured before AZA treatment . Results : Sixty-nine patients receiving maintenance therapy were analyzed . A positive correlation was found between 6-TGN levels and AZA dose ( r = 0.258 , p = 0.032 ) . The mean 6-TGN concentration was 302.06 ± 115.84 in the remission group vs. 264.94 ± 164.53 pmol/8 × 108 RBC in those with active disease ( t = 0.847 , p = 0.40 ) , and 197.74 ± 66.54 pmol/8 × 108 RBC in patients who relapsed vs. 310.26 ± 122.38 pmol/8 × 108 RBC for those in sustained remission ( t= −2.541 , p = 0.013 ) . In the leukopenia group , the 6-TGN concentration was 469.11 ± 115.53 pmol/8 × 108 RBC vs. 257.31 ± 83.74 pmol/8 × 108 RBC in the non-leukopenia group ( t = 7.622 , p < 0.001 ) . There was a significant negative correlation between leukocyte count and 6-TGN concentration ( r= −0.326 , p = 0.006 ) . Conclusions : 6-TGN measurement is a helpful method of preventing disease relapse and avoiding leukopenia in individual azathioprine maintenance therapy Objectives : There is some uncertainty regarding how to best dose and therapeutically monitor 6-mercaptopurine or azathioprine in patients with inflammatory bowel disease . The purpose of this study was to assess the relation between clinical response , 6-mercaptopurine metabolite levels , relative leukopenia , and drug dose . Methods : 60 patients with inflammatory bowel disease who were on stable doses of 6-mercaptopurine or azathioprine for ≥ 3 months and who had measurements of 6-mercaptopurine metabolite levels were evaluated . Patients were classified as complete responders ( N = 24 ) , partial responders ( N = 7 ) , or non-responders ( N = 29 ) . Results : Drug dose was associated with clinical response when we analyzed adjusted doses based on molecular drug weight ( P = 0.002 ) . 6-Thioguanine levels also were associated with clinical response ( P = 0.003 ) and the maximal difference between responders and non-responders was seen at 6-thioguanine levels greater than 260 pmol/8 × 108 RBC . Relative leukopenia , defined as white blood cell count less than either 5.0 or 4.0 K/ u L , was not associated with clinical response ( P = 0.13 and 0.77 respectively ) . Conclusions :1 . Drug dose and 6-thioguanine levels are related to clinical response in patients with inflammatory bowel disease on 6-mercaptopurine or azathioprine . 2 . For 6-thioguanine levels , there is a fair amount of overlap , but maximal differentiation between responders and non-responders is seen at levels > 260 pmol/8 × 108 RBC . 3 . Relative leukopenia does not correlate well with clinical response BACKGROUND AND AIM There have been no reports on 6-thioguanine nucleotide ( 6-TGN ) concentrations in Japanese patients with inflammatory bowel disease ( IBD ) undergoing azathioprine ( AZA ) or 6-mercaptopurine ( 6-MP ) therapy . The aim of this study was to assess 6
Output:
| Conclusions This study reinforces the link between 6-thioguanine nucleotide levels and clinical remission in inflammatory bowel diseases , also exploring the validity of specific 6-thioguanine nucleotide thresholds to predict clinical outcomes |
MS211602 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A multicenter , r and omized , open-label , parallel-group study was conducted to compare the safety and efficacy of perioperative recombinant human erythropoietin ( Epoetin alfa ) with the safety and efficacy of preoperative autologous donation ( PAD ) in total joint arthroplasty . A total of 490 patients scheduled for total joint ( i.e. , hip or knee ) surgery and having hemoglobin ( Hb ) levels > or = 11 to < or = 13 g/dL were r and omized to receive weekly doses of subcutaneous Epoetin alfa on preoperative Days -21 , -14 , and -7 , and on the day of surgery , or to participate in a PAD program . The mean baseline Hb level in both groups was 12.3+/-0.6 g/dL , increasing to 13.8 g/dL in the Epoetin alfa-treated group and decreasing to 11.1 g/dL in the PAD group before or on the day of surgery . In the PAD group , 156/219 ( 71.2 % ) patients were transfused with autologous blood , and 42/219 ( 19.2 % ) patients were transfused with allogeneic blood . A smaller proportion , 27/209 ( 12.9 % ) patients , in the Epoetin alfa-treated group were transfused with allogeneic blood ( P = .078 compared with the PAD group ) . Moreover , patients in the PAD group received a total of 325 units of blood ( 79 allogeneic units and 246 autologous units ) compared with patients in the Epoetin alfa group who received a total of 54 units of blood . The mean postoperative Hb level was 11.0 g/dL in the Epoetin alfa-treated group and 9.2 g/dL in the PAD group . Compared with the PAD arm , mean Hb levels measured preoperatively , postoperatively on Day 1 , and at discharge visits were significantly greater in the Epoetin alfa-treated arm ( P < .0001 ) PURPOSE Allogeneic blood transfusions have reportedly been associated with a poor prognosis in patients with curatively resected cancer . To control for immunosuppression induced by a speculatively causal allogeneic blood transfusion , we design ed a r and omized study in which the control group received autologous blood transfusions not related to any condition of immunosuppression . PATIENTS AND METHODS One hundred twenty patients with potentially curative resectable colorectal cancer and the capability to predeposit autologous blood were r and omly selected to receive either st and ard allogeneic blood transfusion or predeposited autologous blood . RESULTS In curatively resected cancer patients , the number who needed allogeneic blood transfusions was reduced from 60 % in the allogeneic blood group to 33 % in the autologous blood group ( P = .009 ) . After a median follow-up duration of 22 months ( range , 8 to 48 ) tumor recurrence was observed in 28.9 % of the allogeneic blood group and 16.7 % of the autologous blood group . Life-table analysis established a tendency toward a shorter tumor-free survival for the allogeneic blood group ( log-rank P = .11 ) . The problem with this analysis was the strong association of allogeneic blood transfusions with tumor recurrence , which interfered in 33 % of patients in the autologous blood group who required additional allogeneic blood transfusions . Multivariate analysis of established risk factors for tumor recurrence and surgery-related variables reflecting potential immunosuppressive conditions showed that only pT stage ( relative risk , 6.61 ; 95 % confidence interval [ CI ] , 1.82 to 23.99 ; P = .004 ) , pN stage ( relative risk , 8.39 ; 95 % CI , 3.15 to 22.33 ; P < .001 ) , and the need for allogeneic blood ( relative risk , 6.18 ; 95 % CI , 2.20 to 17.37 ; P < .001 ) were independent predictors of tumor recurrence . Subgroup analysis of patients who received a transfusion of < or = 2 U blood found a significantly higher risk of tumor recurrence in the allogeneic blood group ( relative risk , 5.16 ; 95 % CI , 1.13 to 23.62 ; P = .034 ) , which was reduced to borderline significance ( relative risk , 3.54 ; 95 % CI , 0.76 to 16.51 ; P = .107 ) by adjustment for tumor ( T ) and node ( N ) stage . CONCLUSION As indicated by these first results , the blood transfusion modality has a significant effect on tumor recurrence after surgical treatment of colorectal cancer . A change in the practice of blood transfusion might thus potentially surpass the impact of any recent adjuvant treatment strategies & NA ; Even though blood transfusion‐associated immunomodulatory effects have been reported , the basic immune mechanism is still not understood . Data from studies on the clinical effects of allogeneic blood‐induced immunosuppression are contradictory . However , there are indications that autologous blood transfusion is not immunologically neutral but has intrinsic immunomodulatory potential . Therefore we investigated in vivo different immunological mediators in 56 r and omized patients of a study comparing autologous and allogeneic blood transfusion in colorectal cancer surgery . Soluble IL‐2 receptor , which is an indicator of general immune activation and the following immunologic refractory phase , indicated immunosuppression was more elevated at the seventh postoperative day in patients with allogeneic transfusions ( p = .013 ) and autologous transfusions ( p = .0003 ) . The immunologic determination of TNF‐&agr ; showed a significant postoperative increase in patients with autologous transfusions only ( p = .0031 ) . However , postoperative increase of soluble TNF‐receptors p55 and p75 was also significant in patients transfused with allogenic blood ( p = .022 ; p = .0014 ) . The response to tetanus toxoid vaccination , an indicator of humoral immunity , was higher in patients transfused with allogeneic rather than autologous blood ( p = .082 ) , whereas responses of patients with autologous transfusions were even lower than in nontransfused patients . The reciprocal was already found for cell‐mediated immunity determined by epicutaneously tested delayed‐type hypersensitivity‐reactions . IL‐10 levels , an indicator of cellular immunosuppression , were determined in 27 additional patients before operation , immediately postoperative , and at the seventh postoperative day . IL‐10 was found elevated immediately postoperative in allogeneic ( p = .011 ) and nontransfused patients only ( p = .042 ) . The data from this study substantiate recent findings of a different immunomodulatory potential of allogeneic and autologous blood transfusion . They furthermore support the hypothesis that autologous blood transfusion does not contain immunologically neutral effects of allogeneic blood , but itself exerts an immunomodulatory effect Background Allogeneic blood transfusions cause immunosuppression . The aim of this study was to determine whether complement anaphylatoxins , cytokines , or both are released in the recipient , after blood transfusions in general , and after autologous blood transfusions in particular . Methods Thirty-one patients having total hip joint replacement surgery were r and omized to receive either allogeneic red blood cells ( n = 15 ) or predeposited autologous whole blood transfusion ( n = 16 ) . Plasma concentrations of the anaphylatoxins C3a and C5a , the terminal C5b-9 complement complex , and cytokines IL-6 and IL-8 in the recipients were repeatedly analyzed before , during , and after surgery . Results Significantly increased concentrations of IL-6 and IL-8 appeared in both groups , with a significantly greater increase in the autologous blood group . Patients in both groups developed a moderate but significant increase of C3a without a significant difference between them . C5a and terminal C5b-9 complement complex were not greatly changed . Conclusions The study showed a greater increase in cytokine concentration after autologous blood transfusion than after allogeneic blood transfusion . The lower response in the latter may result from transfusion-induced suppression of cellular immunity The aim was to assess the cost-effectiveness of erythropoietin ( EPO ) to reduce patients ' exposure to perioperative allogenic blood products in orthopaedic surgery . The use of EPO was assessed for EPO used alone and for EPO , to augment preoperative autologous donation ( PAD ) . A decision analytical model was design ed incorporating ( i ) the risk of receiving allogeneic blood , ( ii ) the costs of blood products , ( iii ) the likelihood of developing transfusion-related diseases , ( iv ) the costs of transfusion-related diseases , ( v ) the impact of transfusion-related diseases on patient morbidity and mortality and ( vi ) the effect of EPO upon the probability of transfusion . The efficacy of EPO was derived from data from a meta- analysis of published r and omized trials . Estimates for the other parameters were obtained by a systematic review of the literature . EPO alone led to only modest incremental benefit compared to no intervention for orthopaedic surgery ( 0.000024 life-years gained per patient ) . As an augmentation to PAD , EPO also led to modest benefits ( 0.000006 life-years gained per patient ) . For EPO compared to no intervention , the incremental cost per life-year gained was $ 66 million ( Canadian ) . For EPO to augment PAD , the incremental cost per life-year gained was $ 329 million ( Canadian ) . Detailed sensitivity analysis did not reveal any circumstances in which the cost-effectiveness ratios reached a level generally considered attractive . On the basis of cost-effectiveness , the use of EPO to reduce perioperative allogeneic transfusions in orthopaedic surgery did not meet criteria conventionally considered acceptable The hematologic and transfusion data of a multicenter r and omized trial investigating the effect of blood transfusions on the 5-year survival were used to study the feasibility of an autologous blood donation program in colorectal cancer patients . Three hundred and ten patients were r and omized for autologous blood transfusions ( predeposition of 2 units ) or homologous blood transfusions , and transfusion rules were st and ardized . The Hb level in the patients who donated blood decreased by 20.1 + /- 1.3 g/l ( mean + /- SEM ) preoperatively and 4.5 + /- 1.8 g/l postoperatively , and in controls 3.7 + /- 1.1 g/l and 16.5 + /- 1.9 g/l ( significantly different between the two groups , both pre- and postoperatively : p less than 0.01 ) . Because blood loss and number of transfusions were similar in both groups , this indicated that either preoperative or postoperative erythropoiesis is stronger in patients who had donated blood . Twenty-three percent of the autologous patients and 61 % of the homologous patients were exposed to homologous blood . The effectiveness of the procedure differed per tumor localization . In patients with a right-sided colon carcinoma , 22 % of the control patients needed homologous blood , compared to 10 % of the autologous patients . In patients with other colon carcinomas , this was 52 and 16 % , respectively , and in patients with a rectal carcinoma 85 and 41 % . We conclude that predeposition of 2 units of blood for colorectal cancer surgery is feasible and useful to prevent homologous blood usage in a significant number of patients with left colon carcinoma or rectal carcinoma OBJECTIVES Due to the discovery in the 1980s that blood transfusion can transmit HIV , there has been increased interest in technologies that reduce the amount of allogeneic blood used during and after surgery . These technologies include drugs ( aprotinin , tranexamic acid , epsilon-aminocaproic acid , erythropoietin ) , devices ( cell salvage ) , and techniques ( acute hemodilution , predeposited autologous donation ) . The purpose of this study was to ascertain the degree of practice variation , if any , that exists for eight technologies in nine countries in orthopedic and cardiac surgery . METHODS In each country , either all hospitals or a r and om sample of hospitals with medical/surgical beds were surveyed between 1995 and 1997 . Two instruments were used . The first instrument was a postcard that asked recipients whether the technologies were currently being used in their hospital for orthopedic and /or cardiac surgery to reduce perioperative allogeneic transfusion . The second question naire elicited information regarding the degree of use both in qualitative and quantitative terms . Data were collected , entered , and analyzed in each country , with summary results su bmi tted to the Canadian coordinating center on a st and ardized data collection form . RESULTS Pharmaceuticals were generally used in a much smaller proportion of hospitals in orthopedic than in cardiac surgery . Aprotinin and tranexamic acid were the drugs most frequently used in cardiac surgery . Nonpharmacological technologies were used to a greater degree than drugs in orthopedic surgery , although there was wide variation among technologies and countries . Acute hemodilution and cell salvage were used in a greater proportion of hospitals for cardiac surgery than orthopedic surgery . CONCLUSIONS The results of this survey indicate
Output:
| REVIEW ER 'S CONCLUSIONS Although the trials of PAD showed a reduction in the need for allogeneic blood the method ological quality of the trials was poor and the overall transfusion rates ( allogeneic and /or autologous ) in these trials were high , and were increased by recruitment into the PAD arms of the trials .
This raises questions about the true benefit of PAD .
In the absence of large , high quality trials using clinical endpoints , it is not possible to say whether the benefits of PAD outweigh the harms |
MS211603 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract Objective : A revised hearing conservation program ( HCP ) was implemented in the Swedish Armed Forces in 2002 . The aim of this study was to evaluate the incidence of significant threshold shifts ( STS ) in male conscripts heavily exposed to noise after the implementation of the new HCP , comparing the results to those of an earlier study from 1999/2000 . Design : The study was prospect i ve and longitudinal , covering the period from reporting to military service to discharge . The outcome measure was the incidence of STS . Statistics from the military insurance system was analysed . Study Sample : A total of 395 conscripts were included in the study ( mean age 19 years ) . The control group ( n : 839 ) consisted of men of the same age . Results : In 2004/2005 the incidence rate of STS was 2.3 % compared to 7.9 % in 1999/2000 and compared to 3.7 % among the controls . The number of cases of auditory complications reported from conscripts to the insurance system has decreased , from 16 to 5/100 000 days of military training , during the last decade . Conclusions : The new HCP apparently reduced the incidence rate of STS to one third compared to before the program was introduced and leveled it to the incidence rate in the control-group not exposed to military noise OBJECTIVES ( 1 ) To conduct a contemporary analysis of historical data on short-term efficacy of a 3-year hearing conservation program conducted from 1992 to 1996 in Wisconsin , USA , with 753 high school students actively involved in farm work ; ( 2 ) to establish procedures for assessment of hearing loss for use in a recently funded follow-up of this same hearing conservation program cohort . METHODS We analyzed a pragmatic cluster-r and omized controlled trial , with schools as the unit of r and omization . Thirty-four rural schools were recruited and r and omized to intervention or control . The intervention included classroom instruction , distribution of hearing protection devices , direct mailings , noise level assessment s , and yearly audiometric testing . The control group received the audiometric testing . RESULTS Students exposed to the hearing conservation program reported more frequent use of hearing protection devices , but there was no evidence of reduced levels of noise-induced hearing loss ( NIHL ) . CONCLUSION Our analysis suggests that , since NIHL is cumulative , a 3-year study was likely not long enough to evaluate the efficacy of this intervention . While improvements in reported use of hearing protection devices were noted , the lasting impact of these behaviors is unknown and the finding merits corroboration by longer term objective hearing tests . A follow-up study of the cohort has recently been started BACKGROUND Noise-induced hearing loss ( NIHL ) is one of the most common occupational diseases and the second most common cause of workers ' cl aims for occupational injuries . OBJECTIVE Due to high prevalence of NIHL and several reports of improper use of hearing protective devices ( HPDs ) , we conducted this study to compare the effect of face-to-face training in effective use of earplugs with appropriate NRR to overprotection of workers by using earplugs with higher than necessary noise reduction rating ( NRR ) . METHODS In a r and omized clinical trial , 150 workers referred to occupational medicine clinic were r and omly allocated to three arms --- a group wearing earplugs with an NRR of 25 with no training in appropriate use of the device ; a group wearing earplugs with an NRR of 25 with training ; another group wearing earplugs with an NRR of 30 , with no training . Hearing threshold was measured in the study groups by real ear attenuation at threshold ( REAT ) method . This trial is registered with Australian New Zeal and clinical trials Registry , number ACTRN00363175 . RESULTS The mean ± SD age of the participants was 28 ± 5 ( range : 19 - 39 ) years . 42 % of participants were female . The mean noise attenuation in the group with training was 13.88 dB , significantly higher than those observed in other groups . The highest attenuation was observed in high frequencies ( 4 , 6 , and 8 kHz ) in the group with training . CONCLUSION Training in appropriate use of earplugs significantly affects the efficacy of earplugs --- even more than using an earplug with higher NRR OBJECTIVES The study was done to determine whether the noise attenuation attained with the use of earplugs can be improved by teaching the proper insertion of earplugs to users . METHODS Fifty-four r and omly selected male subjects were divided into an untrained group ( 25 persons ) and a trained group ( 29 persons ) . The trained group was given a lecture on earplug insertion and allowed to practise the insertion procedure , whereas the untrained group acted as controls . The untrained group received this training afterwards . The success of the training was measured by the MIRE ( microphone in real ear ) and REAT ( real ear at threshold ) methods , visual evaluation and an analysis of the properties of the subjects ' ear canals . RESULTS According to the MIRE method , the averaged A-weighted noise attenuation was 21 dB for the untrained group and 31 dB for the trained group . With the REAT method the attenuation at 1000 Hz was 24 dB for the untrained group and 30 dB for the trained group . The visual evaluation of the earplug fit was 1.9 for the untrained group and 2.6 for the trained group ( scales 0 - 3 ) . CONCLUSION The results indicate that training in earplug insertion is important for good attenuation and for diminishing poor attenuation to a minimum Objective Occupationally acquired noise-induced hearing loss ( NIHL ) is the most prevalent occupational disease in Austria and among the most common in many other countries . Because of the wide variation in hearing loss after equivalent exposures it has long been assumed that some individuals are more vulnerable to occupational NIHL than others . Earlier attempts to define predictors of NIHL before starting occupational noise exposure have largely failed . We present results of a prospect i ve study evaluating the potential of temporary threshold shift ( TTS ) after a test exposure to predict NIHL . Methods Between 1982 and 1989 , overall 311 apprentices were included into a prospect i ve study during their initial health screening visit . At this occasion , a st and ardised noise exposure was applied ( 20 min , 200–500 Hz , 100 dBA ) and the TTS at 4 kHz was determined during at least 10 min after exposure . Hearing loss was monitored at follow-up visits every 3–5 years . Follow-up was 13 years on average . Results Permanent threshold shift was predicted by duration of noise exposure , frequency of wearing noise protectors and especially by the initial TTS at 4 kHz . Using 14 dB TTS as a cut-off had 82 % sensitivity and 53 % specificity to predict 20 dB or higher levels of NIHL . Conclusions The TTS model can be successfully applied as a method to detect individuals at greater risk of occupational NIHL . It is recommended to routinely include such a procedure into initial workers ’ examinations for suitability to work under occupational noise conditions and for counselling on the use of hearing protectors OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity OBJECTIVES To review the evidence suggesting that occupational hearing conservation programs prevent noise-induced hearing loss ; to describe the features , prevalence , and h and icap associated with noise-induced hearing loss ; and to describe the otolaryngologist 's role in prevention of noise-induced hearing loss . DATA SOURCES Recent statements from the American College of Occupational Medicine , the National Institutes of Health , and the International Organization for St and ardization are supplemented by published articles known to the author ( no formal literature search was done ) . STUDY SELECTION Articles that purported to measure the effects of occupational hearing conservation programs on preventing noise-induced hearing loss . DATA EXTRACTION Each article was separately critiqued without a priori assessment criteria . DATA SYNTHESIS Several studies suggest that occupational hearing conservation programs prevent noise-induced hearing loss , but none of these are conclusive . No r and omized clinical trial has been reported , of which I am aware , and previously reported data suffer from one or more of the following shortcomings : failure to match treatment and control groups for age , nonoccupational noise exposure , and /or prior hearing loss ; failure to control for audiometric learning effects ; and inclusion of workers who had already worked long careers without hearing protection ( and thus had little risk of additional noise-induced loss ) . CONCLUSION Although noise reduction for individuals obviously can prevent noise-induced hearing loss , to my knowledge , no single study offers convincing evidence of the efficacy of occupational hearing conservation programs , primarily due to method ologic flaws The aim of the study was to investigate the incidence and the relative risk of significant threshold shift ( STS , ≥15 dB deterioration at any ear and audiometric frequency ) during primary military service ( 7–9 months ) , and to investigate whether subjects with an initial slight hearing loss ( thresholds ≥ 25 dB HL at any audiometric frequency and ear ) were under increased risk . The investigation was made as a prospect i ve audiometric study and included 747 men . An age-matched group of 138 individuals served as an unexposed control group , whose incidence of STS was 2.9 % . In the exposed group the incidence was 7.9 % and the relative risk 2.7 risk ratio ( RR ) . In the subgroup of 95 persons , who already at reporting-for-training had a mild hearing loss , the incidence was 17 % . The relative risk for STS in this group compared to the control group was 6.8 ( RR ) , and compared to those with normal hearing at reporting was 3.1 ( RR ) . In spite of hearing conservation efforts , hearing deterioration still occurs , above all in the artillery . Those who already at reporting-for-training had a mild hearing loss were at higher risk for STS compared to those with initially normal hearing Although r and omised trials are widely accepted as the ideal way of obtaining unbiased estimates of treatment effects , some treatments have dramatic effects that are highly unlikely to reflect inadequately controlled biases . We compiled a list of historical examples of such effects and identified the features of convincing inferences about treatment effects from sources other than r and omised trials . A unifying principle is the size of the treatment effect ( signal ) relative to the expected prognosis ( noise ) of the condition . A treatment effect is inferred most confidently when the signal to noise ratio is large and its timing is rapid compared with the natural course of the condition . For the examples we considered in detail the rate ratio often exceeds 10 and thus is highly unlikely to reflect bias or factors other than a treatment effect . This model may help to reduce controversy about evidence for treatments whose effects are so dramatic that r and omised trials are unnecessary . The relation between a treatment and its effect is sometimes so dramatic that bias can be ruled out as an explanation . Paul Glasziou and colleagues suggest how to determine when observations speak for
Output:
| Earmuffs might perform better than earplugs in high noise levels but worse in low noise levels ( very low- quality evidence ) .
Better use of HPDs might reduce hearing loss but other components not ( very low- quality evidence ) .
Hearing loss prevention and interventions modestly reduce noise exposure and hearing loss . |
MS211604 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective . To evaluate the quality of life ( QOL ) of untreated children with newly diagnosed attention-deficit/hyperactivity disorder ( ADHD ) , compared with asthmatic and healthy children . Methods . This prospect i ve , case-control study included a group of 120 children , 6 to 12 years of age , with newly diagnosed ADHD according to the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition . Subjects were matched according to age , gender , and health care area with 2 control groups , ie , 93 asthmatic children and 120 healthy children . Sociodemographic characteristics and Child Health Question naire scores were collected . Results . The QOL of children with ADHD was rated worse than that of asthmatic or healthy children for most Child Health Question naire domains . The greatest differences were found in behavior , social limitations attributable to physical problems , emotional impact on parents , and family activities . Almost every psychosocial domain was more affected in comparison with asthmatic children and both psychosocial and physical domains in comparison with healthy children . Conclusions . ADHD interferes with the daily lives of children , parents , and families even more than asthma , primarily in areas related to psychosocial functioning , although evidence of impaired physical functioning also emerged . Delays in recognition , assessment , and management of ADHD may affect negatively the QOL of those children Objective To describe the methodology and to present the baseline findings of the Attention-deficit/hyperactivity Disorder Observational Research in Europe ( ADORE ) study , the primary objective of which is to describe the relationship between treatment regimen prescribed and quality of life of children with ADHD in actual practice . Methods In this 2-year prospect i ve observational study , data on diagnosis , prescribed treatment and outcomes of ADHD were collected at seven time points by paediatricians and child psychiatrists on 1,573 children recruited in 10 European countries . The data presented here from the 1,478 patients included in the analyses describe the baseline condition , initial treatment regimen prescribed and quality of life of families with children with ADHD . Results Patients had a mean age of 9.0 years ( SD 2.5 ) and 84 % were male . Physicians diagnoses were made using DSM-IV ( 43 % ) , ICD-10 ( 32 % ) and both DSM-IV and ICD-10 ( 12 % ) . Mean age of awareness of a problem was 5.1 years , suggesting an average delay of approximately 4 years between awareness and diagnosis of ADHD . Baseline ADHD rating scale scores ( physicianrated ) indicated moderate to severe ADHD . Parent-rated SDQ scores were in agreement and suggested significant levels of co-existing problems . CGI-S , CGAS and CHIPCE scores also indicated significant impairment . Patients were offered the following treatments after the initial assessment : pharmacotherapy ( 25 % ) , psychotherapy ( 19 % ) , combination of pharmacotherapy and psychotherapy ( 25 % ) , other therapy ( 10 % ) and no treatment ( 21 % ) . Conclusion The ADORE study shows that ADHD is similarly recognised across 10 European countries and that the children are significantly impaired across a wide range of domains . In this respect , they resemble children described in previous ADHD sample Purpose To evaluate the effect of atomoxetine on quality of life ( QoL ) and family burden in children and adolescents with attention deficit/hyperactivity disorder ( ADHD ) and comorbid oppositional defiant ( ODD ) or conduct disorder ( CD ) . Methods This secondary analysis was based on a r and omized , double-blind , 9-week study of atomoxetine ( target dose 1.2 mg/kg body weight ) versus placebo . The study included 180 patients ( atomoxetine 121 , placebo 59 ) , aged 6–17 years . QoL was measured using the KINDL-R question naire . The total score encompasses six dimensions ( or subscales ) measuring QoL in terms of “ physical well-being ” , “ emotional well-being ” , “ self-esteem ” , “ friends ” , “ family ” , and “ school ” . Family burden of illness was measured using the FaBel question naire . Results With atomoxetine , the KINDL-R total score improved significantly ( P = 0.021 ) more than with placebo . This improvement also applied to the subscales except for “ physical well-being ” ( opposite effect ) and “ school ” ( no effect ) . No significant treatment group differences were seen on the FaBel question naire . No differences were found between the fast and slow titration groups in terms of ADHD , ODD , and disruptive behavior severity . Furthermore , no such differences were observed for QoL and family burden . Conclusions This study suggests positive effects of atomoxetine on quality of life , as measured by the KINDL-R scores on emotional well-being , self-esteem , friends and family , in children and adolescents with ADHD and comorbid ODD/CD . No significant treatment effects were seen on family burden , as measured by FaBel total score OBJECTIVE The aim of this study was to examine global functioning , health-related quality of life ( HRQOL ) , and clinical outcome in children and adolescents with bipolar I disorder , schizophrenia , or schizoaffective disorder following ziprasidone treatment . METHODS Sixty-three subjects ( aged 10 - 17 years ) received open-label ziprasidone , titrated from 10 to 40 mg twice a day ( b.i.d . ) ( low-dose group ) or from 20 to 80 mg b.i.d . ( high-dose group ) ; fixed doses were used until week 3 , followed by flexible doses for 6 months . The Children 's Global Assessment Scale ( CGAS ) characterized functional impairment at baseline and following treatment . The Child Health Question naire ( CHQ ) assessed HRQOL at baseline . RESULTS Baseline CHQ showed greater impairment in psychosocial functioning than in physical health . Baseline mean CGAS scores were substantially below normal ( i.e. , < 70 ) , indicating functional impairment . Improvement in CGAS scores occurred as early as the first week of treatment . The low correlations between both CHQ and CGAS and the efficacy measures at baseline indicate that these scales measure different constructs . Nevertheless , there was good correlation between improvements in the CGAS and changes in Brief Psychiatric Rating Scale-Anchored ( BPRS-A ) and Young Mania Rating Scale ( YMRS ) during ziprasidone treatment . CONCLUSION CHQ and CGAS scales may be useful together with st and ard efficacy measures for children and adolescents with these disorders Measurement of health-related quality of life ( HRQOL ) in attention-deficit-hyperactivity disorder ( ADHD ) gives a more complete picture of day-to-day functioning and treatment effects than behavioural rating alone . The aim of this pilot study was to investigate the impact of the combined diagnoses of developmental coordination disorder ( DCD ) and ADHD on HRQOL , and the effectiveness of methylpheni date ( MPH ) on HRQOL . HRQOL was established using the Dutch-Child-AZL-TNO- Quality -of-Life ( DUX-25 ) and the TNO-AZL-Child- Quality -of-Life ( TACQOL ) question naires , completed by children and parents . HRQOL of these children was compared with that of 23 age- and sex-matched healthy controls . Twenty-three children ( 21 males , two females ; mean age 8 y 6 mo , [ SD 3 mo ] range 7 y-10 y 8 mo ) with ADHD/DCD entered a 4-week , open-label MPH study , after MPH-sensitivity was established , in a double-blind , placebo-controlled trial . In these children 's self- and proxy reports , impact of both DCD and ADHD was reflected in lower general well-being ( self and proxy report p=0.001 ) due to lower functioning in motor ( selfp=0.026 ; proxy 0.001 ) , autonomic ( self p<0.001 ; proxy p=0.047 ) , cognitive ( self p=0.001 ; proxy p=0.01 ) , and social ( self and proxy p<0.001 ) domains . HRQOL scores improved in 18 children receiving MPH ( p=0.001 ) versus controls . The ADHD /DCD group also demonstrated a significant improvement in ADHD symptoms ( p<0.001 ) and motor functioning ( p<0.001 ) . Additional motor therapy will still be needed in about half of the children with ADHD/DCD receiving MPH , within multimodal treatment including educational and psychosocial assistance ABSTRACT . Clinical research on attention-deficit hyperactivity disorder ( ADHD ) has begun to integrate measures of health-related quality of life ( HRQL ) as part of the overall assessment of treatment outcomes . This study examines the association between HRQL and measures of clinical symptoms of ADHD . Data were gathered from 297 children and adolescents in an 8-week , r and omized , double-blind , placebo-controlled , clinical trial of atomoxetine treatment for ADHD . HRQL was assessed with the Child Health Question naire 50-item Parent Form . ADHD symptoms were assessed with the ADHD Rating Scale-IV ; Parent Version and Clinical Global Impressions-ADHD-Severity . Associations between HRQL and clinical symptoms were assessed with correlations , analyses of variance with post hoc comparisons , and t tests . The Child Health Question naire 50-item Parent Form scales assessing psychosocial domains of HRQL were significantly negatively correlated with clinical measures . Improvement in clinical symptoms was associated with corresponding improvement in psychosocial aspects of HRQL . The findings suggest that HRQL instruments can add important information to efficacy measures in clinical trials of ADHD treatment
Output:
| These studies revealed that the QOL of children with various mental disorders is compromised across multiple domains .
The largest effect sizes were found for psychosocial and family-related domains and for the total QOL score , whereas physical domains generally were less affected .
Conclusions Children with mental disorders experience a considerable reduction in QOL across various domains . |
MS211605 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective Home dampness and the presence of mold and allergens have been associated with asthma morbidity . We examined changes in asthma morbidity in children as a result of home remediation aim ed at moisture sources . Design In this prospect i ve , r and omized controlled trial , symptomatic , asthmatic children ( n = 62 ) , 2–17 years of age , living in a home with indoor mold , received an asthma intervention including an action plan , education , and individualized problem solving . The remediation group also received household repairs , including reduction of water infiltration , removal of water-damaged building material s , and heating/ventilation/air-conditioning alterations . The control group received only home cleaning information . We measured children ’s total and allergen-specific serum immuno-globulin E , peripheral blood eosinophil counts , and urinary cotinine . Environmental dust sample s were analyzed for dust mite , cockroach , rodent urinary protein , endotoxin , and fungi . The follow-up period was 1 year . Results Children in both groups showed improvement in asthma symptomatic days during the preremediation portion of the study . The remediation group had a significant decrease in symptom days ( p = 0.003 , as r and omized ; p = 0.004 , intent to treat ) after remodeling , whereas these parameters in the control group did not significantly change . In the postremediation period , the remediation group had a lower rate of exacerbations compared with control asthmatics ( as treated : 1 of 29 vs. 11 of 33 , respectively , p = 0 . 003 ; intent to treat : 28.1 % and 10.0 % , respectively , p = 0.11 ) . Conclusion Construction remediation aim ed at the root cause of moisture sources and combined with a medical/behavioral intervention significantly reduces symptom days and health care use for asthmatic children who live in homes with a documented mold problem BACKGROUND Exposure to cat and dog allergens is very common in the Western World and is a serious cause of asthma in sensitized subjects . OBJECTIVE We sought to study the clinical effects of air cleaners in living rooms and bedrooms of asthmatic children sensitized to cat or dog allergens . METHODS Twenty asthmatic children sensitized to pet allergens ( cat/dog ) and with an animal at home participated in a double-blind , placebo-controlled , cross-over study in which the effects of air cleaners placed in the living room and bedroom for 3 months were compared with the effects of sham air cleaners . Before and after each study period , lung function , airway hyperresponsiveness ( adenosine monophosphate ) , and peak flow variation were recorded . Cat and dog allergen levels were assessed in the filters of the air cleaners . RESULTS After a 3-month intervention with active air cleaners , airway hyperresponsiveness decreased significantly , showing a 1.2 doubling dose increase of PC(20 ) adenosine ( P = .003 ) . Peak flow amplitude also decreased ( P = . 045 ) . Substantial amounts of airborne cat and dog allergen were captured by the air cleaners in living rooms and bedrooms as well . Allergen levels in floor dust were not changed . CONCLUSION In young asthmatic patients sensitized and exposed to pets in the home , application of air cleaners in living rooms and bedrooms was accompanied by a significant improvement in airway hyperresponsiveness and a decrease in peak flow amplitude BACKGROUND Environmental exposures to indoor allergens are major contributors to asthma symptoms , particularly in inner cities . The effectiveness of household allergen reduction as an adjunct to National Asthma Education Prevention Program guideline -based pharmacologic therapy in asthma has not been prospect ively studied . OBJECTIVE To study the effect of individualized allergen reduction on ability to reduce asthma pharmacologic therapy over 40 weeks . METHODS We performed a r and omized controlled trial to determine the effect of multifaceted indoor allergen avoidance measures on the ability to reduce asthma controller therapy in adults and children residing in New York City who were both sensitized and exposed to at least 1 indoor allergen . Asthma treatment and control were optimized in all subjects before r and omization . RESULTS A total of 125 subjects were r and omized to receive individualized household allergen reduction and 122 received a sham intervention . Subjects in the intervention group significantly reduced all measured allergen levels ( cat , dog , dust mite allergens in the bedroom , cockroach and mouse allergens in the kitchen and bedroom ) ; those in the control group reduced only dust mite and mouse allergens in the bedroom and cockroach allergen in the kitchen . Participants in the intervention arm reduced National Asthma Education Prevention Program-based therapy from step 4.4 at r and omization to 3.50 postintervention ( range , 0 - 6 ) ; participants in the control arm reduced medication from step 4.4 to 3.4 ( P = .76 ) . There were no differences in other measured asthma outcomes . CONCLUSIONS Targeted allergen avoidance measures do not allow for reduction in asthma pharmacologic therapy compared with usual care in patients already receiving optimal controller therapy Background Exposure to cockroaches is an important asthma trigger , particularly for children with asthma living in inner cities . Integrated pest management is the recommended approach to cockroach abatement ; however , it is costly and difficult to implement . The impact of reducing cockroach exposure on asthma outcomes is not known . Objective We sought to test the use of a single intervention , insecticidal bait , to reduce cockroach exposure in the home of children with asthma in New Orleans and to examine the impact of cockroach reduction on asthma outcomes . Methods One hundred two children aged 5 to 17 years with moderate to severe asthma were enrolled in a 12‐month r and omized controlled trial testing the use of insecticidal bait on cockroach counts and asthma morbidity . Homes were visited 6 times and asthma symptoms were assessed every 2 months . Results After adjustment , intervention homes had significantly fewer cockroaches than did control homes ( mean change in cockroaches trapped , 13.14 ; 95 % CI , 6.88‐19.39 ; P < .01 ) . Children in control homes had more asthma symptoms and unscheduled health care utilization in the previous 2 weeks ( 1.82 , 95 % CI , 0.14‐3.50 , P = .03 ; 1.17 , 95 % CI , 0.11‐2.24 , P = .03 , respectively ) and a higher proportion of children with FEV1 of less than 80 % predicted ( odds ratio , 5.74 ; 95 % CI , 1.60‐20.57 ; P = .01 ) compared with children living in intervention homes . Conclusions Previous research has demonstrated improvement in asthma health outcomes using multifaceted interventions . The strategic placement of insecticidal bait , which is inexpensive , has low toxicity , and is widely available , result ed in sustained cockroach elimination over 12 months and was associated with improved asthma outcomes . This single intervention may be an alternative to multifaceted interventions currently recommended to improve asthma morbidity Background Despite medical advice , many pet‐allergic asthma sufferers refuse to remove the pet to which they are sensitized from their home Objective To determine whether insulating existing houses increases indoor temperatures and improves occupants ' health and wellbeing . Design Community based , cluster , single blinded r and omised study . Setting Seven low income communities in New Zeal and . Participants 1350 households containing 4407 participants . Intervention Installation of a st and ard retrofit insulation package . Main outcome measures Indoor temperature and relative humidity , energy consumption , self reported health , wheezing , days off school and work , visits to general practitioners , and admissions to hospital . Results Insulation was associated with a small increase in bedroom temperatures during the winter ( 0.5 � C ) and decreased relative humidity ( −2.3 % ) , despite energy consumption in insulated houses being 81 % of that in uninsulated houses . Bedroom temperatures were below 10 � C for 1.7 fewer hours each day in insulated homes than in uninsulated ones . These changes were associated with reduced odds in the insulated homes of fair or poor self rated health ( adjusted odds ratio 0.50 , 95 % confidence interval 0.38 to 0.68 ) , self reports of wheezing in the past three months ( 0.57 , 0.47 to 0.70 ) , self reports of children taking a day off school ( 0.49 , 0.31 to 0.80 ) , and self reports of adults taking a day off work ( 0.62 , 0.46 to 0.83 ) . Visits to general practitioners were less often reported by occupants of insulated homes ( 0.73 , 0.62 to 0.87 ) . Hospital admissions for respiratory conditions were also reduced ( 0.53 , 0.22 to 1.29 ) , but this reduction was not statistically significant ( P=0.16 ) . Conclusion Insulating existing houses led to a significantly warmer , drier indoor environment and result ed in improved self rated health , self reported wheezing , days off school and work , and visits to general practitioners as well as a trend for fewer hospital admissions for respiratory conditions To evaluate the effect of a room high-efficiency particulate air ( HEPA ) cleaner on cat-induced asthma and rhinitis , 35 cat-allergic subjects who were living with one or more cats were studied in a double-blind , placebo controlled trial . After a 1 mo baseline period , subjects ' bedrooms were equipped with an active or placebo air cleaner for the following 3 mo . Evaluations included monthly measurement of cat-allergen levels , daily morning , afternoon , and nighttime nasal- and chest-symptom scores , twice-daily measurement of peak-flow rates , daily medication scores , monthly spirometry , and methacholine ( MCh ) challenge testing before and after the study . Airborne allergen levels were reduced in the active-filter group as compared with the placebo group ( p = 0.045 ) . However , no differences were detected in settled-dust allergen levels ( p = 0.485 ) , morning , afternoon , or nighttime nasal-symptom scores ( p = 0.769 , 0.534 , and 0.138 ) , chest-symptom scores ( p = 0.388 , 0.179 , and 0.215 ) , sleep disturbance ( p = 0.101 ) , morning or afternoon peak-flow rates ( p = 0 . 424 and 0.679 ) , or rescue medication use ( nasal , p = 0.164 , chest , p = 0.650 ) , respectively . Although the combination of a HEPA room air cleaner , mattress and pillow covers , and cat exclusion from the bedroom did reduce airborne cat-allergen levels , no effect on disease activity was detected for any parameter studied Background : In temperate climates , exposure to house dust mite ( HDM ) allergens is the strongest environmental risk factor for childhood asthma . Environmental modifications to limit exposure have the potential to reduce the prevalence of asthma . The aim of this study was to reduce allergen exposure for children at high risk of developing asthma Abstract Background : Dust mite allergens can induce allergic sensitization and exacerbate asthma symptoms . Although dust mite reduction and control strategies exist , few asthmatics employ them . Objectives : We examined whether an in-home test kit , which quantifies dust mite allergen levels , result ed in behavioral changes in implementation and maintenance of mite reduction strategies and helped reduce allergen levels in homes of dust mite-sensitive children . Methods : We enrolled 60 households of children aged 5–15 with parent-reported dust mite allergy into a r and omized controlled trial . Intervention homes ( N = 30 ) received educational material about reducing dust mites and test kits at 1 , 2 , 5 and 8 months . Control homes ( N = 30 ) received only educational material . At baseline , 6 and 12 months , study staff visited all homes , collected dust sample s from three locations and obtained information about parents ’ mite reduction behaviors by question naire . Allergen concentrations ( Der f 2/Der p2 ) in dust were assessed by immunoassays . After adjusting for visit and location , allergen concentrations in intervention and control homes were compared using mixed effects model analysis . Results : In the intervention homes , allergen concentrations in the child ’s bedroom and living room floors were significantly reduced over time compared to control homes . Although not all location-specific differences in allergen concentrations were statistically significant , combining data across locations , there was a differential reduction in allergen concentrations in the intervention group versus the control group ( p = 0.02 ) . Conclusion : The use of in-home test kits along with education may beneficially influence behaviors and attitudes toward dust mite reduction strategies and help reduce residential dust mite allergen levels BACKGROUND Clinical ly relevant reductions in exposure to cockroach allergen , an important risk factor for asthma in inner-city households , have proven difficult to achieve in intervention trials . OBJECTIVE This study investigated a method for the abatement of cockroach allergen in low-income , urban homes . The goal was to reduce mean Bla g 1 concentrations below the previously proposed thresholds for allergic sensitization and asthma morbidity . METHODS A prer and omized , nonmasked trial with 16 intervention and 15 control homes was conducted . Study inclusion was based on 50 to 500 cockroaches trapped in a 3-day period . The interventions consisted of occupant education , placement of insecticide bait , and professional cleaning . V
Output:
| Summary Given evidence for effective interventions , control of environmental exposures should lead to improved asthma outcomes . |
MS211606 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results OBJECTIVE To assess the effects of metoprolol on perioperative cardiovascular events in patients with risk or at high risk for coronary artery disease ( CAD ) who were to undergo non-cardiac surgery . METHODS 102 patients with definite CAD or at high risk for CAD who were to undergo selective non-cardiac surgery were r and omized to 2 equal groups : Group A ( blank control group ) and Group B given metoprolol orally or intravenously from 2 h before surgery to 30 days after surgery . The dosage of metoprolol was adjusted according to the blood pressure and heart rate . The changes of peri-operative heart rate ( HR ) , level of creatine kinase (CK)-MB , cardiac events such as unstable angina pectoris ( UAP ) and myocardial infa rct ion ( MI ) , death , and stroke were recorded . RESULTS The HR values , intra-operative and 6 h , 1 d , and 2 d after operation of Group B were all significantly lower than those of Group A ( all P < 0.05 ) . One patient from each group had MI . One case of death and two cases of strokes occurred in Group A. The occurrence rate of at least one cardiovascular event were 9.8 % in Group A ( 5/51 ) and 2.0 % in Group B ( 1/51 ) without significant difference between these 2 groups ( P > 0.05 ) . CONCLUSIONS Metoprolol reduces the incidence of postoperative severe cardiovascular episodes in patients with risk of or at high risk for CAD undergoing non-cardiac surgery Background Perioperative opioid administration results in postoperative nausea and vomiting ( PONV ) and acute opioid tolerance that manifests in increased postoperative pain . Esmolol is an ultra short acting cardioselective β1-adrenergic receptor antagonist , and it has been successfully used for perioperative sympatholysis and it reduces the opioid requirement during total intravenous anesthesia . We tested the hypothesis that perioperative esmolol administration results in decreased PONV and postoperative pain . Methods Sixty patients undergoing laparoscopic appendectomy were r and omly assigned to two groups ( Group E and Group C ) . The Group E patients were administered 5 - 10 µg/kg/min esmolol with remifentanil that was titrated to the autonomic response . The Group C patients received normal saline that was of the same volume as the esmolol in Group E , and the remifentanil was also titrated to the vital sign . Before intubation and extubation , the Group E patients were administered 1.0 mg/kg esmolol , and the Group C patients were administered normal saline of the same volume . The incidence and severity of PONV , the pain score , the rescue antiemetics and the rescue analgesics were assessed 30 min , 6 h and 24 h after surgery . The mean arterial pressure and heart rate under anesthesia were also recorded . Results PONV and postoperative pain were significantly increased in Group C. These patients needed more antiemetics and analgesics in the first 24 postoperative hours . The mean arterial pressure and heart rate were significantly higher in Group C at the time of intubation and extubation . Conclusions Perioperative esmolol administration contributes to the significant decrease in PONV and postoperative pain , and so this facilitates earlier discharge Objectives : Atrial fibrillation after cardiac surgery is associated with increases in the risk of complications , length of intensive care unit stay , and cost of care . Beta blockers are effective for controlling myocardial ischemia and arrhythmia and suppressing inflammatory cytokines . The purpose of this study was to examine the effect of administrating a short-acting beta-adrenoceptor antagonist , l and iolol , on postoperative atrial fibrillation . Methods : 136 patients undergoing off-pump coronary artery bypass grafting were single-blindly assigned r and omly to l and iolol ( n = 68 ) and non-l and iolol ( control , n = 68 ) groups . In the l and iolol group , the beta blocker was administered from the beginning of the operation until postoperative day 2 . The primary endpoint was the incidence of atrial fibrillation until postoperative day 7 , and the secondary endpoints were the postoperative levels of troponin I , creatine kinase MB-isoenzyme , and C-reactive protein . Results : The incidence of atrial fibrillation was significantly lower in the l and iolol group compared to the control group ( 13/68 , 19 % vs. 25/68 , 37 % , p = 0.02 , logrank test ) . L and iolol also significantly reduced the postoperative peak C-reactive protein level compared to the control group ( 132 ± 55.4 vs. 161 ± 50.9 mgċL−1 , p = 0.004 ) . Conclusion : Low-dose continuous infusion of l and iolol reduced the incidence of postoperative atrial fibrillation , and significantly suppressed inflammation BACKGROUND Trials of beta blockers in patients undergoing non-cardiac surgery have reported conflicting results . This r and omised controlled trial , done in 190 hospitals in 23 countries , was design ed to investigate the effects of perioperative beta blockers . METHODS We r and omly assigned 8351 patients with , or at risk of , atherosclerotic disease who were undergoing non-cardiac surgery to receive extended-release metoprolol succinate ( n=4174 ) or placebo ( n=4177 ) , by a computerised r and omisation phone service . Study treatment was started 2 - 4 h before surgery and continued for 30 days . Patients , health-care providers , data collectors , and outcome adjudicators were masked to treatment allocation . The primary endpoint was a composite of cardiovascular death , non-fatal myocardial infa rct ion , and non-fatal cardiac arrest . Analyses were by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00182039 . FINDINGS All 8351 patients were included in analyses ; 8331 ( 99.8 % ) patients completed the 30-day follow-up . Fewer patients in the metoprolol group than in the placebo group reached the primary endpoint ( 244 [ 5.8 % ] patients in the metoprolol group vs 290 [ 6.9 % ] in the placebo group ; hazard ratio 0.84 , 95 % CI 0.70 - 0.99 ; p=0.0399 ) . Fewer patients in the metoprolol group than in the placebo group had a myocardial infa rct ion ( 176 [ 4.2 % ] vs 239 [ 5.7 % ] patients ; 0.73 , 0.60 - 0.89 ; p=0.0017 ) . However , there were more deaths in the metoprolol group than in the placebo group ( 129 [ 3.1 % ] vs 97 [ 2.3 % ] patients ; 1.33 , 1.03 - 1.74 ; p=0.0317 ) . More patients in the metoprolol group than in the placebo group had a stroke ( 41 [ 1.0 % ] vs 19 [ 0.5 % ] patients ; 2.17 , 1.26 - 3.74 ; p=0.0053 ) . INTERPRETATION Our results highlight the risk in assuming a perioperative beta-blocker regimen has benefit without substantial harm , and the importance and need for large r and omised trials in the perioperative setting . Patients are unlikely to accept the risks associated with perioperative extended-release metoprolol Background : Increased sympathetic activity perioperatively and associated cardiovascular effects play a central role in cardiovascular complications . High thoracic epidural blockade attenuates the sympathetic response , but even with complete pain relief , haemodynamic and endocrine responses are still present . Beta – adrenoceptor blockade is effective in situations with increased sympathetic activity . This study was design ed to evaluate the perioperative haemodynamic effect of preoperative βblockade and its influence on the haemodynamic aspects of the surgical stress response This double-blind , r and omized , placebocontrolled study evaluated the sparing effect of esmolol on sevoflurane during laparoscopic gynaecological surgery in 54 patients between December 2009 and May 2010 . The concentration of sevoflurane required to maintain adequate anaesthesia was determined . Patients received either a 0.5 mg/kg esmolol intravenous loading dose followed by infusion of 30 μg/kg per min or an identical volume of normal saline ( placebo ) . During surgery the input concentration of sevoflurane was adjusted every 5 min to maintain systolic blood pressure within 15 % of baseline and bispectral index at 50–60 . Infusion of esmolol result ed in an 18.2 % decrease in mean sevoflurane input concentration . Patients receiving esmolol had an earlier discharge from the postanaesthetic care unit and a lower mean fentanyl dose . In conclusion , intraoperative esmolol infusion decreased both the requirement for sevoflurane and postoperative administration of fentanyl Sotalol is a beta-adrenergic blocking drug with the additional property of lengthening the cardiac action potential . These electrophysiologic properties render the drug attractive for use in the prevention of postoperative supraventricular arrhythmias ( SVA ) , and previous studies have suggested that it was indeed effective . The hemodynamic response to sotalol and its safety early after coronary artery bypass graft ( CABG ) surgery were therefore studied . Forty-two patients undergoing CABG were r and omly assigned either to receive sotalol to prevent postoperative SVA ( 25 patients ) or to serve as controls ( 17 patients ) . Sotalol was started 6 hours after surgery if patients had a cardiac index > 2.8 L/min/m2 with a pulmonary capillary wedge pressure < 15 mmHg , and if they had no contraindications to the use of beta-blockers . The drug was given as a loading infusion of 1 mg/kg over 2 hours , followed by a maintenance infusion of 0.15 mg/kg/h for 24 hours . Three hours later , patients received the first oral dose of 80 mg to be repeated every 8 or 12 hours . Adverse effects necessitating discontinuation of the drug ( bradycardia < 50 beats/min , systolic blood pressure < 90 mmHg , or cardiac index < 2.2 L/min/m2 ) occurred in six patients ( 24 % ) and were mainly related to the loading infusion . The hemodynamic data for patients who completed the study were characterized by a significant fall of the cardiac index caused by a lower heart rate without significant change of the stroke volume index . The incidence of supraventricular arrhythmias was not significantly different in the two groups ( 3/19 in the sotalol group , 5/17 in the control group ) . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVE Supraventricular tachyarrhythmias ( SVT ) complicate postoperative management after coronary bypass surgery in about 30 % of all patients . Though a prophylactic treatment both with beta-adrenergic blocking agents and the calcium antagonist diltiazem has been used for the prevention of post-operative SVT , no study yet has performed a prospect i ve comparison of the efficacy of these therapies . METHODS To investigate the prophylactic effect of either a calcium antagonist ( diltiazem , 0.1 mg/kg per h i.v . ) or a beta-adrenergic blocking agent ( propranolol , 10 mg every 6 h postoperatively ) , we r and omized prospect ively 103 consecutive patients into three groups , the third one serving as a control group . Anti-arrhythmic medication was started with the procedure and was continued until the 3rd postoperative day . RESULTS Preoperative conditions were the same for the three groups concerning age , extent of coronary heart disease , ventricular function and heart-related medication . There were no differences in intraoperative parameters or post
Output:
| According to our findings , perioperative application of beta-blockers still plays a pivotal role in cardiac surgery , as they can substantially reduce the high burden of supraventricular and ventricular arrhythmias in the aftermath of surgery .
Their influence on mortality , AMI , stroke , congestive heart failure , hypotension and bradycardia in this setting remains unclear .
In non-cardiac surgery , evidence from low risk of bias trials shows an increase in all-cause mortality and stroke with the use of beta-blockers .
The substantial reduction in supraventricular arrhythmias and AMI in this setting seems to be offset by the potential increase in mortality and stroke |
MS211607 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background The mechanisms thorough which spinal manipulative therapy ( SMT ) exerts clinical effects are not established . A prior study has suggested a dorsal horn modulated effect ; however , the role of subject expectation was not considered . The purpose of the current study was to determine the effect of subject expectation on hypoalgesia associated with SMT . Methods Sixty healthy subjects agreed to participate and underwent quantitative sensory testing ( QST ) to their leg and low back . Next , participants were r and omly assigned to receive a positive , negative , or neutral expectation instructional set regarding the effects of a specific SMT technique on pain perception . Following the instructional set , all subjects received SMT and underwent repeat QST . Results No interaction ( p = 0.38 ) between group assignment and pain response was present in the lower extremity following SMT ; however , a main effect ( p < 0.01 ) for hypoalgesia was present . A significant interaction was present between change in pain perception and group assignment in the low back ( p = 0.01 ) with participants receiving a negative expectation instructional set demonstrating significant hyper algesia ( p < 0.01 ) . Conclusion The current study replicates prior findings of c- fiber mediated hypoalgesia in the lower extremity following SMT and this occurred regardless of expectation . A significant increase in pain perception occurred following SMT in the low back of participants receiving negative expectation suggesting a potential influence of expectation on SMT induced hypoalgesia in the body area to which the expectation is directed OBJECTIVE To examine the effects of adjunctive postoperative massage and vibration therapy on short-term postsurgical pain , negative affect , and physiologic stress reactivity . DESIGN Prospect i ve , r and omized controlled trial . The treatment groups were : ( 1 ) usual postoperative care ( UC ) ; ( 2 ) UC plus massage therapy ; or ( 3 ) UC plus vibration therapy . SETTING The University of Virginia Hospital Surgical Units , Gynecology-Oncology Clinic , and General Clinical Research Center . SUBJECTS One hundred and five ( N = 105 ) women who underwent an abdominal laparotomy for removal of suspected cancerous lesions . INTERVENTIONS All patients received UC with analgesic medication . Additionally , the massage group received st and ardized 45-minute sessions of gentle Swedish massage on the 3 consecutive evenings after surgery and the vibration group received 20-minute sessions of inaudible vibration therapy ( physiotones ) on the 3 consecutive evenings after surgery , as well as additional sessions as desired . OUTCOME MEASURES Sensory pain , affective pain , anxiety , distress , analgesic use , systolic blood pressure , 24-hour urine free cortisol , number of postoperative complications , and days of hospitalization . RESULTS On the day of surgery , massage was more effective than UC for affective ( p = 0.0244 ) and sensory pain ( p = 0.0428 ) , and better than vibration for affective pain ( p = 0.0015 ) . On postoperative day 2 , massage was more effective than UC for distress ( p = 0.0085 ) , and better than vibration for sensory pain ( p = 0.0085 ) . Vibration was also more effective than UC for sensory pain ( p = 0.0090 ) and distress ( p = .0090 ) . However , after controlling for multiple comparisons and multiple outcomes , no significant differences were found . CONCLUSIONS Gentle Swedish massage applied postoperatively may have minor effects on short-term sensory pain , affective pain , and distress among women undergoing an abdominal laparotomy for removal of suspected malignant tissues OBJECTIVE The purpose of this study was to investigate the effects of ice massage postexercise on pressure pain thresholds ( PPTs ) over the quadriceps muscle and the electromyography ( EMG ) root mean square ( RMS ) . METHODS Fifteen athletes ( female , 8 ; age , 19 + /- 2 years ) participated . Subjects were required to visit the laboratory on 2 separate occasions with a 1-week interval between sessions . Participants performed 5 isokinetic concentric dominant knee extension contractions at 60 degrees , 120 degrees , 180 degrees , and 240 degrees /s . After exercise , they were r and omly assigned to receive either an ice massage or detuned ultrasound for 15 minutes , 1 on each session . The PPT and RMS during maximal voluntary contraction were measured over the vastus medialis ( VM ) , vastus lateralis ( VL ) , and rectus femoris ( RF ) muscles at baseline , postexercise , and 5 minutes postintervention . The hypothesis of interest was the intervention x time interaction . RESULTS The analysis of covariance found a significant intervention x time interaction for PPT over the VM ( F = 17.3 , P < .001 ) and VL ( F = 5.4 , P = .03 ) muscles but not over the RF ( F = 1.2 , P = .3 ) , indicating an increase in PPT after the ice massage . An intervention x time interaction was found for RMS of the VL ( F = 5.8 , P = .01 ) but not of the VM ( F = 0.5 , P = .5 ) or RF ( F = 0.01 , P = .9 ) muscles , indicating an increase in RMS after the ice massage . A significant positive correlation between PPT and RMS for the VL muscle was identified ( r = 0.6 , P = .03 ) . CONCLUSION Ice massage after isokinetic exercise produced an immediate increase of PPT over the VL and VM and EMG activity over the VL muscle in recreational athletes , suggesting that ice massage may result in a hypoalgesic effect and improvements in EMG activity The treatment of lateral epicondylalgia , a widely-used model of musculoskeletal pain in the evaluation of many physical therapy treatments , remains somewhat of an enigma . The protagonists of a new treatment technique for lateral epicondylalgia report that it produces substantial and rapid pain relief , despite a lack of experimental evidence . A r and omized , double blind , placebo-controlled repeated- measures study evaluated the initial effect of this new treatment in 24 patients with unilateral , chronic lateral epicondylalgia . Pain-free grip strength was assessed as an outcome measure before , during and after the application of the treatment , placebo and control conditions . Pressure-pain thresholds were also measured before and after the application of treatment , placebo and control conditions . The results demonstrated a significant and substantial increase in pain-free grip strength of 58 % ( of the order of 60 N ) during treatment but not during placebo and control . In contrast , the 10 % change in pressure-pain threshold after treatment , although significantly greater than placebo and control , was substantially smaller than the change demonstrated for pain-free grip strength . This effect was only present in the affected limb . The selective and specific effect of this treatment technique provides a valuable insight into the physical modulation of musculoskeletal pain and requires further investigation AIM The purpose of this study was to examine the effects of ice massage on the signs and symptoms associated with exercise-induced muscle damage . METHODS Nine recreationally resistance trained males performed an exercise protocol design ed to induce muscle damage on 2 separate occasions ; this was performed on the dominant or non-dominant arm in a r and om cross over design . The protocol consisted of 3 sets of 10 repetitions of single arm biceps curls , at 70 % of a pre-determined one repetition maximum ( 1RM ) , with the eccentric phase of the contraction extended to 7 seconds . Subjects were also r and omly assigned to an ice massage group or control group in the cross over design and received treatments immediately post-exercise , 24 hours and 48 hours post-exercise . 1RM , plasma creatine kinase ( CK ) , muscle soreness ( DOMS ) , limb girth and range of motion ( ROM ) were measured pre , immediately post , 24 hours , 48 hours and 72 hours post-exercise . RESULTS Significant time effects were observed for all dependent variables ( p<0.05 ) , though no significant group effects were observed . A group by time interaction was found for CK ( p<0.05 ) , which at 72 hours post-exercise was significantly lower in the ice massage group ( p<0.05 ) . CONCLUSION These results indicate that although ice massage reduces the appearance of CK it has no other effect on signs and symptoms associated with exercise-induced muscle damage OBJECTIVE This study analyzed and compared the effects of manual lymph drainage therapy ( MLDT ) and connective tissue massage ( CTM ) in women with primary fibromyalgia ( PFM ) . METHODS The study design was a r and omized controlled trial . Fifty women with PFM completed the study . The patients were divided r and omly into 2 groups . Whereas 25 of them received MLDT , the other 25 underwent CTM . The treatment program was carried out 5 times a week for 3 weeks in each group . Pain was evaluated by a visual analogue scale and algometry . The Fibromyalgia Impact Question naire ( FIQ ) and Nottingham Health Profile were used to describe health status and health-related quality of life ( HRQoL ) . Wilcoxon signed rank test and Mann-Whitney U test were used to analyze the data . RESULTS In both groups , significant improvements were found regarding pain intensity , pain pressure threshold , and HRQoL ( P < .05 ) . However , the scores of FIQ-7 ( P = .006 ) , FIQ-9 ( P = .006 ) , and FIQ-total ( P = .010 ) were significantly lower in the MLDT group than they were in the CTM group at the end of treatment . CONCLUSIONS For this particular group of patients , both MLDT and CTM appear to yield improvements in terms of pain , health status , and HRQoL. The results indicate that these manual therapy techniques might be used in the treatment of PFM . However , MLDT was found to be more effective than CTM according to some subitems of FIQ ( morning tiredness and anxiety ) and FIQ total score . Manual lymph drainage therapy might be preferred ; however , further long-term follow-up studies are needed Abstract Objectives : To compare the efficacy of acupuncture and conventional massage for the treatment of chronic neck pain . Design : Prospect i ve , r and omised , placebo controlled trial . Setting : Three outpatient departments in Germany . Participants : 177 patients aged 18–85 years with chronic neck pain . Interventions : Patients were r and omly allocated to five treatments over three weeks with acupuncture ( 56 ) , massage ( 60 ) , or “ sham ” laser acupuncture ( 61 ) . Main outcome measures : Primary outcome measure : maximum pain related to motion ( visual analogue scale ) irrespective of direction of movement one week after treatment . Secondary outcome measures : range of motion ( 3D ultrasound real time motion analyser ) , pain related to movement in six directions ( visual analogue scale ) , pressure pain threshold ( pressure algometer ) , changes of spontaneous pain , motion related pain , global complaints ( seven point scale ) , and quality of life ( SF-36 ) . Assessment s were performed before , during , and one week and three months after treatment . Patients ' beliefs in treatment were assessed . Results : One week after five treatments the acupuncture group showed a significantly greater improvement in motion related pain compared with massage ( difference 24.22 ( 95 % confidence interval 16.5 to 31.9 ) , P=0.0052 ) but not compared with sham laser ( 17.28 ( 10.0 to 24.6 ) , P=0.327 ) . Differences between acupuncture and massage or sham laser were greater in the subgroup who had had pain for longer than five years ( n=75 ) and in patients with myofascial pain syndrome ( n=129 ) . The acupuncture group had the best results in most secondary outcome measures . There were no differences in patients ' beliefs in treatment . Conclusions : Acupuncture is an effective short term treatment for patients with chronic neck pain , but there is only limited evidence for long term effects after five treatments . What is already known on this topic Acupuncture is a widespread complementary treatment Evidence from trials have given conflicting results on its use in the treatment of neck pain because of method ological shortcomings and because effects were compared either with alternative treatments or with different sham procedures imitating acupuncture , but not both What this study adds Compared with sham laser acupuncture and massage , needle acupuncture has beneficial effects on mobility and pain related to motion in patients with chronic neck pain Acupuncture was clearly more effective than massage , but differences were not always significant compared with sham laser acupuncture Acupuncture was the best treatment for patients with the myofascial syndrome and those who had had pain for longer than five This study tested the effectiveness of episodic transcutaneous electrical nerve stimulation ( TENS ) as a supplement to pharmacologic analgesia on pain with movement and at rest after abdominal surgery and evaluated whether its use during walking and vital capacity maneuvers enhances performance of these activities . TENS , with a modulated frequency , intensity as high as the subject could tolerate , and electrodes placed on either side and parallel to the incision , was compared to placebo TENS and pharmacologic analgesia alone ( control ) by using a crossover design . Self-report of pain intensity , walking function , and vital capacity were assessed on 33 subjects . TENS result ed in significantly less pain than the control during both walking ( P < .5 ) and vital capacity activities ( P < .1 ) and significantly less pain than placebo TENS during vital capacity ( P < .01 ) . TENS also produced significantly better gait speeds than the control ( P < .05 ) and greater gait distances ( P < .01 ) than the control and placebo TENS . Vital capacity and pain intensity at rest were not significantly different among the 3 treatments . These results suggest TEN
Output:
| MBT demonstrated a favorable and consistent ability to modulate pain sensitivity .
Short-term modulation of pain sensitivity was associated with short-term beneficial effects on clinical pain .
Intensity of MBT , but not duration , was linked with change in pain sensitivity .
The results suggest that MBT had a favorable effect on pressure pain thresholds when compared with no-treatment and sham/inert groups , and effects comparable with those of other active treatments . |
MS211608 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: RATIONALE Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis . OBJECTIVES To test whether vitamin D supplementation of patients with tuberculosis ( TB ) improved clinical outcome and reduced mortality . METHODS We conducted a r and omized , double-blind , placebo-controlled trial in TB clinics at a demographic surveillance site in Guinea-Bissau . We included 365 adult patients with TB starting antituberculosis treatment ; 281 completed the 12-month follow-up . The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment . MEASUREMENTS AND MAIN RESULTS The primary outcome was reduction in a clinical severity score ( TBscore ) for all patients with pulmonary TB . The secondary outcome was 12-month mortality . No serious adverse effects were reported ; mild hypercalcemia was rare and present in both arms . Reduction in TBscore and sputum smear conversion rates did not differ among patients treated with vitamin D or placebo . Overall mortality was 15 % ( 54 of 365 ) at 1 year of follow-up and similar in both arms ( 30 of 187 for vitamin D treated and 24 of 178 for placebo ; relative risk , 1.19 [ 0.58 - 1.95 ] ) . HIV infection was seen in 36 % ( 131 of 359 ) : 21 % ( 76 of 359 ) HIV-1 , 10 % ( 36 of 359 ) HIV-2 , and 5 % ( 19 of 357 ) HIV-1 + 2 . CONCLUSIONS Vitamin D does not improve clinical outcome among patients with TB and the trial showed no overall effect on mortality in patients with TB ; it is possible that the dose used was insufficient . Clinical trial registered with www.controlled-trials.com/is rct n ( IS RCT N35212132 ) Background : Micronutrient supplementation has been shown to reduce the progression of HIV but does not have an effect on the intestinal barrier or the intestinal microbiota of HIV patients . Studies have suggested that probiotics could potentially complement micronutrients in preserving the immune-function of HIV patients . Objective : Assess the impact of micronutrient supplemented probiotic yogurt on the immune function of HIV patients . Design : We performed a r and omized , double blind , controlled trial with CD4 count as primary outcome among HIV patients naïve to anti-retroviral treatment . Secondary outcomes included hematological parameters , incidence of diarrhea and clinical symptoms . A total of 112 HIV patients were r and omized to receive a micronutrient fortified yogurt with ( n = 55 ) or without additional probiotic Lactobacillus rhamnosus GR-1 ( n = 57 ) for four weeks . Results : An average decline in CD4 count of −70 cells/μL ( 95 % CI : −154 to −15 ) was observed in the micronutrient , probiotic group versus a decrease of −63 cells/μL ( 95 % CI : −157 to −30 ) in the micronutrient control group ( p = 0.9 ) . Additional probiotic supplementation was well tolerated and not associated with adverse events . No difference between groups was detected in incidence of diarrhea or clinical symptoms . An improvement of hemoglobin levels was observed for all subjects , based upon a mean difference from baseline of 1.4 g/L ( SD = 6 ) ( p = 0.02 ) . Conclusion : The addition of probiotics to a micronutrient fortified yogurt was well tolerated by HIV patients but was not associated with a further increase in CD4 count after one month Background Use of multivitamin supplements during the pre-HAART era has been found to reduce viral load , enhance immune response , and generally improve clinical outcomes among HIV-infected adults . However , immune reconstitution is incomplete and significant mortality and opportunistic infections occur in spite of HAART . There is insufficient research information on whether multivitamin supplementation may be beneficial as adjunct therapy for HIV-infected individuals taking HAART . We propose to evaluate the efficacy of a single recommended daily allowance ( RDA ) of micronutrients ( including vitamins B-complex , C , and E ) in slowing disease progression among HIV-infected adults receiving HAART in Ug and a. Methods / Design We are using a r and omized , double-blind , placebo-controlled trial study design . Eligible patients are HIV-positive adults aged at least 18 years , and are r and omized to receive either a placebo ; or multivitamins that include a single RDA of the following vitamins : 1.4 mg B1 , 1.4 mg B2 , 1.9 mg B6 , 2.6 mcg B12 , 18 mg niacin , 70 mg C , 10 mg E , and 0.4 mg folic acid . Participants are followed for up to 18 months with evaluations at baseline , 6 , 12 and 18 months . The study is primarily powered to examine the effects on immune reconstitution , weight gain , and quality of life . In addition , we will examine the effects on other secondary outcomes including the risks of development of new or recurrent disease progression event , including all-cause mortality ; ARV regimen change from first- to second-line therapy ; and other adverse events as indicated by incident peripheral neuropathy , severe anemia , or diarrhea . Discussion sThe conduct of this trial provides an opportunity to evaluate the potential benefits of this affordable adjunct therapy ( multivitamin supplementation ) among HIV-infected adults receiving HAART in a developing country setting .Trial registration Clinical Trial Registration -URL : http://www . clinical trials.gov . Unique identifier : BACKGROUND Suboptimal vitamin D ( vitD ) status is common in children and young adults infected with human immunodeficiency virus ( HIV ) . The vitD supplemental dose needed to normalize vitD status in this population is unknown . METHODS In this double-blind trial , subjects infected with HIV ages 8.3 to 24.9 years were r and omized to vitD3 supplementation of 4000 IU/day or 7000 IU/day and evaluated at 6 and 12 week for changes in vitD status and HIV indicators . A dose was considered unsafe if serum calcium was elevated ( above age and sex-specific range ) associated with elevated serum 25 hydroxyvitamin D ( 25(OH)D ) ; > 160 ng/mL ) . RESULTS At baseline , 95 % of subjects ( n = 44 ; 43 % with perinatally acquired HIV , 57 % with behaviorally acquired HIV ) had a suboptimal serum 25(OH)D concentration of < 32 ng/mL ( mean ± st and ard deviation , 19.3 ± 7.4 ; range , 4.4 - 33.6 ng/mL ) . After 12 weeks ( main outcome ) of D3 supplementation , both D3 doses were safe and well tolerated , with no evidence of elevation of serum calcium concentrations or deterioration in HIV immunologic or virologic status . Sufficient vitD status , defined as serum 25(OH)D ≥32 ng/mL , was achieved in 81 % of all subjects , and only the 7000 IU/day group ( 86 % ) achieved this a priori efficacy criterion in > 80 % of subjects . Change in serum 25(OH)D did not differ between HIV acquisition groups . CONCLUSIONS A 7000 IU/day D3 supplementation was safe and effective in children and young adults infected with HIV Background : Iron deficiency is common among female injection drug users , but it is unclear whether iron supplementation can reduce anemia and improve iron status without increasing plasma hepatitis C virus ( HCV ) or HIV RNA levels . Methods : We conducted a phase 3 , double-blind , r and omized , controlled clinical trial of daily micronutrients with 18 mg of iron ( iron group ) versus micronutrients without iron ( control group ) for 12 months among hepatitis C-positive female injection drug users in Baltimore , Maryl and . The main outcome measures were hemoglobin , markers of iron status , plasma HCV RNA , plasma HIV RNA , and liver enzymes at 6 and 12 months of follow-up . Results : Four hundred fifty-eight women ( 320 HIV-negative and 138 HIV-positive ) enrolled in the trial . There were no significant differences in the proportion of women with anemia , ferritin < 30 ng/mL , log10 plasma HCV RNA , or log10 plasma HIV RNA between treatment groups at enrollment . The proportion with anemia in the iron and control groups , respectively , was 20.7 % versus 31.3 % ( P = 0.026 ) at 6 months and 26.2 % versus 30.4 % ( P = 0.5 ) at 12 months ; with ferritin < 30 ng/mL , the proportion was 29.2 % versus 55.5 % ( P < 0.0001 ) at 6 months and 26.2 % versus 46.9 % ( P = 0.0018 ) at 12 months . In the iron and control groups , respectively , mean log10 plasma HCV RNA ( IU/mL ) was 5.2 versus 5.2 ( P = 0.86 ) at 6 months and 5.4 versus 5.3 ( P = 0.6 ) at 12 months . Among HIV-positive subjects , mean log10 plasma RNA ( copies/mL ) in the iron and placebo groups , respectively , was 3.8 versus 3.7 ( P = 0.75 ) at 6 months and 3.7 versus 4.1 ( P = 0.19 ) at 12 months . There were no significant differences in liver enzyme levels between the treatment groups at enrollment , 6 months , and 12 months . Conclusions : A daily micronutrient supplement with iron can reduce anemia and improve iron status in female injection drug users without increasing plasma HCV or HIV RNA levels or altering liver enzymes BACKGROUND Studies suggest that vitamin D deficiency is a risk factor for cardiovascular disease and diabetes . Vitamin D deficiency is prevalent in HIV patients but the effect of vitamin D supplementation on cardiovascular risk in this population is unknown . METHODS We conducted a r and omized , double-blind , placebo-controlled trial among 45 HIV-infected adults in Clevel and ( OH , USA ) on stable antiretroviral therapy with durable virological suppression and a baseline serum 25-hydroxyvitamin D level of ≤20 ng/ml . Participants were r and omized 2:1 to vitamin D3 4,000 IU daily or placebo for 12 weeks . The primary outcome was a change in flow-mediated brachial artery dilation ( FMD ) . RESULTS Baseline demographics were similar except for age ( vitamin D versus placebo , mean ±sd 47 ±8 versus 40 ±10 years ; P=0.009 ) . Both groups had reduced FMD at baseline ( median values 2.9 % [ IQR 1.6 - 4.8 ] for vitamin D versus 2.5 % [ IQR 1.7 - 6.4 ] for placebo ; P=0.819 ) . Despite an increase in the concentration of serum 25-hydroxyvitamin D from baseline to 12 weeks ( 5.0 ng/ml [ IQR -0.9 - 7.4 ] versus -1.9 ng/ml [ IQR -4.0 - 0.1 ] for vitamin D versus placebo , respectively ; P=0.003 ) , there was no difference in FMD change ( 0.55 % [ IQR -1.05 - 2.13 ] versus 0.29 % [ IQR -1.61 - 1.77 ] ; P=0.748 ) . Vitamin D supplementation was associated with a decrease in total and non-high-density lipoprotein cholesterol , and an increase in indices of insulin resistance . CONCLUSIONS Among HIV-infected individuals with vitamin D deficiency , supplementation with 4,000 IU vitamin D3 daily for 12 weeks modestly improved vitamin D status and cholesterol but worsened insulin resistance without change in endothelial function . The mechanisms of resistance to st and ard doses of vitamin D and the complex role of vitamin D in glucose metabolism in this population require further investigation Background Approximately 30 % of HIV-1-infected patients receiving antiretroviral therapy who achieve virologic control have unsatisfactory immune reconstitution , with CD4 + T-cell counts persistently below 350 cells/μL. These patients are at elevated risk for clinical progression to AIDS and non-AIDS events . CD4 + T-cell depletion following infection and persistent immune activation can partially explain this low CD4 + T-cell recovery . Recent data suggest a link between the tryptophan oxidation pathway , immune activation and HIV disease progression based on overstimulation of the tryptophan oxidation pathway by HIV antigens and by interferon-gamma . This overstimulation reduces levels of circulating tryptophan , result ing in inflamm
Output:
| Supplementation probably does increase blood concentrations of vitamin D and zinc ( data not pooled , vitamin D : 4 trials , 299 participants , zinc : 4 trials , 484 participants , moderate certainty evidence ) and may also increase blood concentrations of vitamin A ( data not pooled , 3 trials , 495 participants , low certainty evidence ) , especially in those who are deficient .
Authors ' conclusions The analyses of the available trials have not revealed consistent clinical ly important benefits with routine multiple micronutrient supplementation in people living with HIV .
These findings should not be interpreted as a reason to deny micronutrient supplements for people living with HIV where specific deficiencies are found or where the person 's diet is insufficient to meet the recommended daily allowance of vitamins and minerals |
MS211609 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Purpose The purpose of the study was to evaluate [18F]fluoromisonidazole ( FMISO ) PET in advanced head and neck cancer during hypoxia-targeting therapy . Methods Fifteen of 16 patients in a phase I trial of chemoradiation plus tirapazamine ( specific cytotoxin for hypoxic cells ) in advanced ( T3/4 and /or N2/3 ) head and neck cancer underwent serial [18F]fluorodeoxyglucose ( FDG ) and FMISO PET . We have previously reported excellent early clinical outcome of these patients and now review FMISO PET results in the context of longer follow-up of this patient cohort . Results Based on blinded qualitative scoring by two readers , FMISO PET was positive in 13/15 patients at baseline : 12/15 of primary sites and 8/13 neck nodes were scored as positive . All sites of corresponding FDG and FMISO abnormality at baseline showed marked qualitative reduction of uptake within 4 weeks of commencing therapy , consistent with effective hypoxia-targeted therapy . With a median follow-up of 6.9 years , there have been only four locoregional failures , while three other patients have died of metachronous lung cancer . The 5-year overall survival was 50 % ( 95 % CI 27–73 % ) , the 5-year failure-free survival was 44 % ( 95 % CI 22–68 % ) and the 5-year freedom from locoregional failure was 68 % ( 95 % CI 38–88 % ) . Conclusion The high prevalence of hypoxia demonstrated on FMISO PET imaging is consistent with the advanced disease stage of these patients and would be expected to predict an adverse prognosis . Evidence of the early resolution of FMISO abnormality during treatment , associated with excellent locoregional control in this patient cohort , supports further investigation of hypoxia-targeting agents in advanced head and neck cancer UNLABELLED In radiotherapy of head and neck cancer ( HNC ) and non-small cell lung cancer ( NSCLC ) , hypoxia is known to be an important prognostic factor for long-term survival and local tumor control . The PET tracer (18)F-fluoromisonidazole ( FMISO ) allows noninvasive assessment of tumor hypoxia . This study analyzed whether FMISO PET could predict tumor recurrence after radiotherapy . METHODS Forty patients with advanced HNC ( n = 26 ) or NSCLC ( n = 14 ) were studied before curative radiotherapy . Dynamic ( 0 - 15 min ) and static PET scans were acquired up to 4 h after injection of 400 MBq of FMISO . St and ardized uptake values ( SUVs ) and ratios to reference tissues ( mediastinum or muscle ) were calculated . In addition , time-activity curves up to 14 min after injection were classified visually . PET data were correlated with clinical follow-up data ( presence or absence of local recurrence within 1 y ) , which were available for 21 patients . RESULTS For HNC , patients with local recurrence could be separated from disease-free patients by SUV 4 h after injection ( all recurrences had an SUV > 2 ) . For NSCLC , no such correlation was observed . The tumor-to-muscle ratios ( T/Mu ) and tumor-to-mediastinum ratios ( T/Me ) at 4 h after injection correlated with the risk of relapse in both tumor entities : All patients with a T/Me greater than 2.0 ( NSCLC , n = 5 ) or with a T/Mu greater than 1.6 ( HNC , n = 5 ) presented with tumor recurrence , whereas only 3 of the remaining 11 patients experienced recurrence ( 27 % ) . Qualitative analysis of time-activity curves for 37 patients revealed 3 curve types ( rapid washout , n = 9 ; intermediate [ delayed washout ] , n = 12 ; and accumulation , n = 16 ) . Eighteen patients categorized by curve type could be followed up : In 5 of 6 patients with an accumulation curve , disease recurred locally within 1 y , compared with 5 of 8 patients with a delayed-washout curve and 0 of 4 with a rapid-washout curve . CONCLUSION Our results indicate that outcome after radiotherapy can be predicted on the basis of kinetic behavior of FMISO in tumor tissue . An accumulation-type curve , high SUV , and high T/Mu and T/Me at 4 h after injection are highly suggestive of an incomplete response to treatment and might be used to select patients for intensified therapy protocol PURPOSE To determine the maximum-tolerated dose of tirapazamine when combined with cisplatin and radiation in patients with T3/4 and /or N2/3 squamous cell carcinoma of the head and neck . PATIENTS AND METHODS The starting schedule was conventionally fractionated radiotherapy ( 70 Gy in 7 weeks ) with concomitant cisplatin 75 mg/m2 and tirapazamine 290 mg/m2 ( before cisplatin ) in weeks 1 , 4 , and 7 and tirapazamine alone 160 mg/m2 three times a week in weeks 2 , 3 , 5 , and 6 . Positron emission tomography scans for tumor hypoxia ( 18F misonidazole ) were performed before and during radiotherapy . RESULTS We treated 16 patients with predominantly oropharyngeal primary tumors , including 10 patients with T4 or N3 disease . Febrile neutropenia occurred toward the end of radiotherapy in three out of six patients treated on the initial dose level . Two of these patients also developed grade 4 acute radiation reactions . Another 10 patients were treated with the same doses , but the week 5 and week 6 tirapazamine doses were omitted . This result ed in less neutropenia and only one dose-limiting toxicity ( DLT ) ( febrile neutropenia ) , and eight out of 10 patients completed treatment without any dose omissions . In these 10 patients , the acute radiation toxicities were not obviously enhanced compared with chemoradiotherapy regimens using concurrent platinum and fluorouracil . 18F misonidazole scans detected hypoxia in 14 of 15 patients at baseline , with only one patient having detectable hypoxia at the end of treatment . With a median follow-up of 2.7 years , the 3-year failure-free survival rate was 69 % ( SE , 12 % ) , the 3-year local progression-free rate was 88 % ( SE , 8 % ) , and the 3-year overall survival rate was 69 % ( SE , 12 % ) . CONCLUSION DLT was due unexpectedly to febrile neutropenia , which could be overcome by omitting tirapazamine in weeks 5 and 6 . The combination of tirapazamine , cisplatin , and radiotherapy result ed in remarkably good and durable clinical responses in patients with very advanced head and neck cancers . It warrants further investigation PURPOSE Angiogenesis is a target for the treatment of cancer and other diseases , and its complex biology suggests that establishing the appropriate dose and schedule for antiangiogenic treatment will require extensive study . We present the initial results of a dose-finding clinical trial of recombinant human endostatin ( rh-Endo ) that examined potential surrogates for response to antiangiogenic therapy . PATIENTS AND METHODS Twenty-five patients were treated with escalating doses of rh-Endo . Positron emission tomography ( PET ) was used to assess tumor blood flow ( with [15O]H2O ) and metabolism ( with [18F]fluorodeoxyglucose ) before the start of therapy and then every 4 weeks . To directly assess the effects of rh-Endo on endothelial cells within the tumors , biopsy specimens of tumor tissue were obtained before therapy and again at 8 weeks and evaluated for endothelial cell and tumor cell apoptosis . RESULTS Tumor blood flow and metabolism as measured by PET scans generally decreased with increasing doses of rh-Endo ; however , the effects were complex and in some analyses nonlinear . Tumor biopsy analysis revealed a significant increase in tumor cell apoptosis ( P = .027 ) and endothelial cell apoptosis ( P = .027 ) after 8 weeks of therapy . However , there was no statistically significant relationship between rh-Endo dose and induction of tumor cell or endothelial cell apoptosis . CONCLUSION These initial data suggest that rh-Endo has measurable effects on tumor blood flow and metabolism and induces endothelial and tumor cell apoptosis even in the absence of demonstrable anticancer effects . Further study and validation of these biomarkers in the context of antiangiogenic therapy will be required Abstract .The aim of this study was to assess the safety and biodistribution of technetium-99 m BRU 59 - 21 , a novel radioactively labelled 2-nitro-imidazole hypoxic marker , in head and neck cancer patients and to correlate uptake with pimonidazole staining . 99mTc-BRU 59 - 21 was administered intravenously ( mean dose 824 MBq , range 780–857 MBq ) to ten head and neck cancer patients scheduled for primary surgery , and whole-body images and SPET scans were then obtained . Uptake of radioactivity in the regions of interest was determined and tumour to normal tissue ratios were calculated after correlative evaluation with MRI/CT . Twelve to 16 h before surgery ( up to 2 weeks after the scan ) , patients received pimonidazole intravenously . Tumour sections were stained immunohistochemically for pimonidazole binding . No serious adverse events were reported . In five patients there were ten adverse events , which were mild in intensity and resolved completely without intervention . Uptake of 99mTc-BRU 59 - 21 was observed in eight of the ten primary tumours . Tumour to normal tissue ratios on the SPET scans for primary tumour and lymph nodes increased from 1.8 ( range 0.9–2.7 ) to 2.1 ( range 0.8–3.7 ) between 30 min and 3 h post injection . Tumour to normal tissue ratios in the primary tumour were significantly correlated with pimonidazole staining for SPET scans performed 30 min and 3 h post injection ( P=0.016 and P=0.037 , respectively ) . When primary tumour and involved lymph nodes were considered in conjunction , correlation between the tumour to normal tissue ratio and pimonidazole staining was observed for early ( P<0.001 ) but not for late SPET scans ( P=0.076 ) . However , late scans showed better tumour delineation than early scans . Administration of 99mTc-BRU 59 - 21 in head and neck cancer patients appears to be safe and feasible . Uptake and retention in tumour tissue was observed , suggestive of tumour hypoxia , and this was supported by correlations with staining for the hypoxic marker pimonidazole Abstract . Fluorine-18 fluoroerythronitroimidazole ( [18F]FETNIM ) is a nitroimidazole compound that is potentially useful as a hypoxia marker in positron emission tomography ( PET ) studies of oncological patients . Our aim was to develop a simple protocol to quantitate uptake of [18F]FETNIM in hypoxic tumours . Dynamic imaging data from ten patients with head and neck cancer undergoing [18F]FETNIM PET was used in simulations and model fits to assess hypoxia marker uptake under different levels of blood flow . The distribution volume determined from dynamic PET study was compared with simple tumour to plasma and tumour to muscle ratios at 90–120 min . In skeletal muscle having a low but variable blood flow [ 2–6 ml/(100 g × min ) ] , differences in hypoxia-specific uptake of [18F]FETNIM remain small and may be hard to detect with PET . At higher blood flow [ > 20 ml/(100 g × min ) ] , the retention of [18F]FETNIM reflects the oxygenation status well and results in satisfactory contrast between hypoxic and well-oxygenated tissue . A good estimate of tissue hypoxia is accomplished by measuring the tissue to plasma [18F]FETNIM activity ratio using only a few late time points . The increased hypoxia-specific retention of [18F]FETNIM in tissues with high blood flow , such as malignant tumours , may facilitate application of [18F]FETNIM as a hypoxia marker in oncological patients . In the assessment of the tumour to non-target uptake ratio , plasma is the preferred reference tissue rather than muscle , which may show a more heterogeneous tracer uptake not easily controlled for Objectives : To compare blood flow measurements of tumors assessed by perfusion computed tomography ( pCT ) and the clinical gold st and ard of 15O-labeled water positron emission tomography ( 15O-PET ) . Methods : Blood flows were estimated by pCT ( 4-row multidetector , CT Perfusion 3.1 ) and 15O-PET ( Posicam , first-pass model ) in 14 patients with solid tumors , totaling 22 index tumors and 57 matched pairs of examinations . Blood flow estimates were compared using t test , Bl and -Altman , and linear mixed regression analyses . Results : There was no significant difference between the mean ( SD ) blood flow values measured by pCT and 15O-PET : 25.9 ± 15.4 and 27.8 ± 14.0 mL/min per 100 g
Output:
| Conclusions A subset of radionuclide methods offers accurate quantitative scientific observations on tumour vascular physiology of relevance to angiogenesis and its treatment . |
MS211610 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Purpose Epidemiologic studies suggest that consumption of green tea may have a protective effect against the development of several cancers . Pre clinical studies of green tea and its polyphenolic components have demonstrated antimutagenic and anticarcinogenic activity , and inhibition of growth of tumor cell lines and animal tumor models , including lung cancer . Green tea may also have chemopreventive properties , and enhancement of cytotoxicity of chemotherapeutic agents has been demonstrated . This trial was design ed to determine the maximum tolerated dose ( MTD ) of green tea extract ( GTE ) in patients with advanced lung cancer . Methods A total of 17 patients with advanced lung cancer were registered to receive once-daily oral dosing of GTE at a starting dose of 0.5 g/m2 per day , with an accelerated dose-escalation scheme . Results On this schedule , the MTD of GTE was 3 g/m2 per day , and at this dose , GTE was well tolerated with no grade 3 or 4 toxicity seen . Dose-limiting toxicities were diarrhea , nausea and hypertension . No objective responses were seen in this trial . Seven patients had stable disease ranging from 4 to 16 weeks ; no patient remained on therapy longer than 16 weeks due to the development of progressive disease . Conclusions This study suggests that while relatively nontoxic at a dose of 3 g/m2 per day , GTE likely has limited activity as a cytotoxic agent , and further study of GTE as a single-agent in established malignancies may not be warranted . Further studies should focus on the potential chemopreventive and chemotherapy-enhancing properties of GTE CONTEXT Green tea polyphenols have been extensively studied as cardiovascular disease and cancer chemopreventive agents in vitro and in animal studies . However , the effects of green tea consumption in humans remain unclear . OBJECTIVE To investigate the associations between green tea consumption and all-cause and cause-specific mortality . DESIGN , SETTING , AND PARTICIPANTS The Ohsaki National Health Insurance Cohort Study , a population -based , prospect i ve cohort study initiated in 1994 among 40,530 Japanese adults aged 40 to 79 years without history of stroke , coronary heart disease , or cancer at baseline . Participants were followed up for up to 11 years ( 1995 - 2005 ) for all-cause mortality and for up to 7 years ( 1995 - 2001 ) for cause-specific mortality . MAIN OUTCOME MEASURES Mortality due to cardiovascular disease , cancer , and all causes . RESULTS Over 11 years of follow-up ( follow-up rate , 86.1 % ) , 4209 participants died , and over 7 years of follow-up ( follow-up rate , 89.6 % ) , 892 participants died of cardiovascular disease and 1134 participants died of cancer . Green tea consumption was inversely associated with mortality due to all causes and due to cardiovascular disease . The inverse association with all-cause mortality was stronger in women ( P = .03 for interaction with sex ) . In men , the multivariate hazard ratios of mortality due to all causes associated with different green tea consumption frequencies were 1.00 ( reference ) for less than 1 cup/d , 0.93 ( 95 % confidence interval [ CI ] , 0.83 - 1.05 ) for 1 to 2 cups/d , 0.95 ( 95 % CI , 0.85 - 1.06 ) for 3 to 4 cups/d , and 0.88 ( 95 % CI , 0.79 - 0.98 ) for 5 or more cups/d , respectively ( P = .03 for trend ) . The corresponding data for women were 1.00 , 0.98 ( 95 % CI , 0.84 - 1.15 ) , 0.82 ( 95 % CI , 0.70 - 0.95 ) , and 0.77 ( 95 % CI , 0.67 - 0.89 ) , respectively ( P<.001 for trend ) . The inverse association with cardiovascular disease mortality was stronger than that with all-cause mortality . This inverse association was also stronger in women ( P = .08 for interaction with sex ) . In women , the multivariate hazard ratios of cardiovascular disease mortality across increasing green tea consumption categories were 1.00 , 0.84 ( 95 % CI , 0.63 - 1.12 ) , 0.69 ( 95 % CI , 0.52 - 0.93 ) , and 0.69 ( 95 % CI , 0.53 - 0.90 ) , respectively ( P = .004 for trend ) . Among the types of cardiovascular disease mortality , the strongest inverse association was observed for stroke mortality . In contrast , the hazard ratios of cancer mortality were not significantly different from 1.00 in all green tea categories compared with the lowest-consumption category . CONCLUSION Green tea consumption is associated with reduced mortality due to all causes and due to cardiovascular disease but not with reduced mortality due to cancer Our study investigates whether tea consumption can enhance the survival of patients with epithelial ovarian cancer , a prospect i ve cohort study was conducted in Hangzhou , China . The cohort comprised 254 patients recruited during 1999 - 2000 with histopathologically confirmed epithelial ovarian cancer and was followed up for a minimum of 3 years . Two hundred forty four ( 96.1 % ) of the cohort or their close relatives were traced . The variables examined included their survival time and the frequency and quantity of tea consumed post-diagnosis . The actual number of deaths was obtained and Cox proportional hazards models were used to obtain hazard ratios and associated 95 % confidence intervals ( CI ) , adjusting for age at diagnosis , locality , BMI , parity , FIGO stage , histologic grade of differentiation , cytology of ascites , residual tumour and chemotherapeutic status . The survival experience was different between tea drinkers and non-drinkers ( p < 0.001 ) . There were 81 ( 77.9 % ) of 104 tea-drinkers who survived to the time of interview , compared to only 67 women ( 47.9 % ) still alive among the 140 non-drinkers . Compared to non-drinkers , the adjusted hazard ratios were 0.55 ( 95 % CI = 0.34 - 0.90 ) for tea-drinkers , 0.43 ( 95 % CI = 0.20 - 0.92 ) for consuming at least 1 cup of green tea/day , 0.44 ( 95 % CI = 0.22 - 0.90 ) for brewing 1 batch or more of green tea/day , 0.40 ( 95 % CI = 0.18 - 0.90 ) for consuming more than 500 g of dried tea leaves/year , and 0.38 ( 95 % CI = 0.15 - 0.97 ) for consuming at least 2 g of dried tea leaves/batch . The corresponding dose-response relationships were significant ( p < 0.05 ) . We conclude that increasing the consumption of green tea post-diagnosis may enhance epithelial ovarian cancer survival The incidence of prostate cancer is much lower in Asian than Western population s. Given that environmental factors such as dietary habits may play a major role in the causation of prostate cancer and the high consumption of green tea in Asian population s , this low incidence may be partly due to the effects of green tea . The JPHC Study ( Japan Public Health Center-based Prospect i ve Study ) was established in 1990 for cohort I and in 1993 for cohort II . The subjects were 49,920 men aged 40 - 69 years who completed a question naire that included their green tea consumption habit at baseline and were followed until the end of 2004 . During this time , 404 men were newly diagnosed with prostate cancer , of whom 114 had advanced cases , 271 were localized , and 19 were of an undetermined stage . Green tea was not associated with localized prostate cancer . However , consumption was associated with a dose-dependent decrease in the risk of advanced prostate cancer . The multivariate relative risk was 0.52 ( 95 % confidence interval : 0.28 , 0.96 ) for men drinking 5 or more cups/day compared with less than 1 cup/day ( p(trend ) = 0.01 ) . Green tea may be associated with a decreased risk of advanced prostate cancer In a prospect i ve study of 19 561 Japanese men , green-tea intake was not associated with a lower risk of prostate cancer ( 110 cases ) , the multivariate hazard ratio for men drinking ⩾5 cups compared with < 1 cup per day being 0.85 ( 95 % confidence interval 0.50–1.43 , trend P=0.81 ) PURPOSE This trial was design ed to determine the maximum-tolerated dose , toxicity , and pharmacology of oral green tea extract ( GTE ) once daily or three times daily . PATIENTS AND METHODS Cohorts of three or more adult cancer patients were administered oral GTE with water after meals one or three times daily for 4 weeks , to a maximum of 6 months , depending on disease response and patient tolerance . Pharmacokinetic analyses were encouraged but optional . RESULTS Dose levels of 0.5 to 5.05 g/m(2 ) qd and 1.0 to 2.2 g/m(2 ) tid were explored . A total of 49 patients were studied . PATIENT CHARACTERISTICS median age , 57 years ( range , 27 to 77 years ) ; 23 patients were women ( 47 % ) ; 98 % had a Zubrod PS of 1 % ; 98 % had PS of 1 ; and 21 had non-small-cell lung , 19 had head & neck cancer , three had mesothelioma , and six had other . Mild to moderate toxicities were seen at most dose levels and promptly reversed on discontinuation of GTE . Dose-limiting toxicities were caffeine related and included neurologic and gastrointestinal effects . The maximum-tolerated dose was 4.2 g/m(2 ) once daily or 1.0 g/m(2 ) three times daily . No major responses occurred ; 10 patients with stable disease completed 6 months of GTE . Pharmacokinetic analyses found accumulation of caffeine levels that were dose dependent , whereas epigallocatechin gallate levels did not accumulate nor appear dose related . CONCLUSION A dose of 1.0 g/m(2 ) tid ( equivalent to 7 to 8 Japanese cups [ 120 mL ] of green tea three times daily ) is recommended for future studies . The side effects of this preparation of GTE were caffeine related . Oral GTE at the doses studied can be taken safely for at least 6 months PURPOSE To evaluate the efficacy and toxicity of green tea , prescribed as an alternative complementary ( CAM ) formulation on hormone refractory prostate cancer ( HRPC ) . METHODS Patients with HRCP were prescribed green tea extract capsules at a dose level of 250 mg twice daily . Efficacy and toxicity were evaluated during monthly visits . The primary endpoint was prostate-specific antigen ( PSA ) or measurable disease progression after a minimum of 2 months of therapy . RESULTS Nineteen patients were enrolled into the study . The treatment was generally well tolerated . Twelve patients reported at least one side effect ; only two of these were of moderate or severe grade . Primary toxicity was related to gastrointestinal irritation or caffeine intake . Four patients did not complete the minimum 2 months of therapy because of : intolerance ( two patients ) , physician stoppage ( one patient ) , death from cerebrovascular accident ( one patient ) . Fifteen patients completed at least 2 months of therapy . Nine of these patients had progressive disease within 2 months of starting therapy . Six patients developed progressive disease after additional 1 to 4 months of therapy . CONCLUSION Green tea , as CAM therapy , was found to have minimal clinical activity against hormone refractory prostate cancer BACKGROUND Although laboratory experiments and case-control studies have suggested that the consumption of green tea provides protection against gastric cancer , few prospect i ve studies have been performed . METHODS In January 1984 , a total of 26,311 residents in three municipalities of Miyagi Prefecture , in northern Japan ( 11,902 men and 14,409 women 40 years of age or older ) , completed a self-administered question naire that included questions about the frequency of consumption of green tea . During 199,748 person-years of follow-up , through December 1992 , we identified 419 cases of gastric cancer ( in 296 men and 123 women ) . We used Cox regression to estimate the relative risk of gastric cancer according to the consumption of green tea . RESULTS Green-tea consumption was not associated with the risk of gastric cancer . After adjustment for sex , age , presence or absence of a history of peptic ulcer smoking status , alcohol consumption , other dietary elements , and type of health insurance , the relative risks associated with drinking one or two , three or four , and five or more cups of green tea per day , as compared with less than one cup per day , were 1.1 ( 95 percent confidence interval , 0.8 to 1.6 ) , 1.0 ( 95 percent confidence interval , 0.7
Output:
| Although the evidence from this review suggested associations between green tea consumption and a decreased risk for some cancers , the findings were inconclusive .
In selected cases , green tea was effective in slowing the progression of the earlier stages of cancer .
However , contrary evidence is reported and the dose and duration of use is variable . |
MS211611 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Early interventions proved to be able to improve prognosis in acute stroke patients . Prompt identification of symptoms , organised timely and efficient transportation towards appropriate facilities , become essential part of effective treatment . The implementation of an evidence based pre-hospital stroke care pathway may be a method for achieving the organizational st and ards required to grant appropriate care . We performed a systematic search for studies evaluating the effect of pre-hospital and emergency interventions for suspected stroke patients and we found that there seems to be only a few studies on the emergency field and none about implementation of clinical pathways . We will test the hypothesis that the adoption of emergency clinical pathway improves early diagnosis and referral in suspected stroke patients . We design ed a cluster r and omised controlled trial ( C- RCT ) , the most powerful study design to assess the impact of complex interventions . The study was registered in the Current Controlled Trials Register : IS RCT N41456865 – Implementation of pre-hospital emergency pathway for stroke – a cluster r and omised trial . Methods / design Two-arm cluster-r and omised trial ( C- RCT ) . 16 emergency services and 14 emergency rooms were r and omised either to arm 1 ( comprising a training module and administration of the guideline ) , or to arm 2 ( no intervention , current practice ) . Arm 1 participants ( 152 physicians , 280 nurses , 50 drivers ) attended an interactive two sessions course with continuous medical education CME credits on the contents of the clinical pathway . We estimated that around 750 patients will be met by the services in the 6 months of observation . This duration allows recruiting a sample of patients sufficient to observe a 30 % improvement in the proportion of appropriate diagnoses . Data collection will be performed using current information systems . Process outcomes will be measured at the cluster level six months after the intervention . We will assess the guideline recommendations for emergency and pre-hospital stroke management relative to : 1 ) promptness of interventions for hyperacute ischaemic stroke ; 2 ) promptness of interventions for hyperacute haemorrhagic stroke 3 ) appropriate diagnosis . Outcomes will be expressed as proportions of patients with a positive CT for ischaemic stroke and symptoms onset < = 6 hour admitted to the stroke unit . Discussion The fields in which this trial will play are usually neglected by R and omised Controlled Trial ( RCT ) . We have chosen the Cluster-r and omised Controlled Trial ( C- RCT ) to address the issues of contamination , adherence to real practice , and community dimension of the intervention , with a complex definition of clusters and an extensive use of routine data to collect the outcomes OBJECTIVE to evaluate whether integrated care pathways improve the processes of care in stroke rehabilitation . DESIGN comparison of processes of care data collected in a r and omized controlled trial . PARTICIPANTS acute stroke patients undergoing rehabilitation r and omized to receive integrated care pathways management ( n=76 ) or conventional multidisciplinary care ( n=76 ) . MEASUREMENTS proportion of patients meeting recommended st and ards for processes of care using a vali date d stroke audit tool . RESULTS integrated care pathways methodology was associated with higher frequency of stroke specific assessment s , notably testing for inattention ( 84 % versus 60 % ; P=0.015 ) and nutritional assessment ( 74 % versus 22 % , P<0.001 ) . Documentation of provision of certain information to patients /carers ( 89 % versus 70 % ; P=0.024 ) and early discharge notification to general practitioners ( 80 % versus 45 % ; P<0.001 ) were also more common in this group . There were no significant differences in the processes of interdisciplinary co-ordination and patient management between the integrated care pathways group and the control group . CONCLUSION integrated care pathways may improve assessment and communication , even in specialist stroke setting BACKGROUND AND PURPOSE Integrated Care Pathway ( ICP ) is an organized , goal -defined , and time-managed plan that has the potential of facilitating timely interdisciplinary coordination , improving discharge planning , and reducing length of hospital stay . METHODS An ICP for stroke rehabilitation based on evidence of best practice , professional st and ards , and existing infrastructure was developed . Its effectiveness was tested in 152 stroke patients undergoing rehabilitation who were r and omized to receive ICP care coordinated by an experienced nurse ( n=76 ) or conventional multidisciplinary care ( n=76 ) . RESULTS The age , sex , premorbid functional ability , and stroke characteristics of the 2 groups were comparable . There were no differences in mortality rates ( 10 [ 13 % ] versus 6 [ 8 % ] ) , institutionalization ( 10 [ 13 % ] versus 16 [ 21 % ] ) , or length of hospital stay ( 50+/-19 versus 45+/-23 days ) between patients receiving ICP or multidisciplinary care . Patients receiving conventional multidisciplinary care improved significantly faster between 4 and 12 weeks ( median change in Barthel Activities of Daily Living Index 6 versus 2 ; P<0.01 ) and had higher Quality of Life scores at 12 weeks ( 65 versus 59 ; P=0.07 ) and 6 months ( 72 versus 63 ; P<0.005 ) . There were no significant differences in the mean duration of physiotherapy ( 42.8+/-41.2 versus 39.4+/-36.4 hours ) or occupational therapy ( 8.5+/-7.5 versus 8.0+/-7.5 hours ) received between the 2 groups . CONCLUSIONS ICP management offered no benefit over conventional multidisciplinary care on a stroke rehabilitation unit . Functional recovery was faster and Quality of Life outcomes better in patients receiving conventional multidisciplinary care OBJECTIVE To assess outcomes of using a clinical pathway for managing patients with fractured neck of femur . DESIGN Prospect i ve , pseudor and omised , controlled trial . SETTING St Vincent 's Hospital , Melbourne , Victoria ( a tertiary referral , university teaching hospital ) , 1 October 1997 to 30 November 1998 . PARTICIPANTS 111 patients ( 80 women and 31 men ; mean age , 81 years ) admitted via the emergency department with a primary diagnosis of fractured neck of femur . INTERVENTIONS Management guided by a clinical pathway ( 55 patients ) or established st and ard of care ( control group , 56 patients ) . MAIN OUTCOME MEASURES Timing of referrals and discharge planning ; total length of stay ; and complication and readmission rates within 28 days of discharge . RESULTS Patients managed according to the clinical pathway had a shorter total stay ( 6.6 versus 8.0 days ; P = 0.03 ) , even if assessment for placement by the Aged Care Assessment Service was required ( 9.5 versus 13.6 days ; P = 0.03 ) . There were no significant differences in complication and readmission rates between pathway and control patients ( complication rates , 24 % versus 36 % ; P = 0.40 ; readmission rates , 4 % versus 11 % ; P = 0.28 ) . CONCLUSION Coordinated multidisciplinary care of patients with fractured neck of femur reduces length of stay without increasing complications UNLABELLED In traditional practice patterns , physicians take care of all clinical decisions , such as diagnosis , treatment , and recovery . In the Nippon Medical School Hospital a clinical pathway for distal gastrectomy patients , recorded as a post-operative care map , was introduced in August 2000 . In January 2001 the post-operative management was analyzed and st and ardization of practice was carried out with printed order sets , such as drugs and infusion solutions . The aim of this study was to evaluate the clinical significance of the clinical pathway for gastrectomy patients by employing st and ardized postoperative management and printed order sets . PATIENTS AND METHODS From January 2001 to December 2001 , 87 patients underwent distal ( 43 ) , total ( 28 ) , proximal ( 7 ) and partial gastrectomy ( 9 ) for gastric cancer ( stage IA : 47 , IB : 9 , II : 7 , IIIA : 8 , IIIB 2 , IV : 10 ) and gastrointestinal stromal tumor ( 4 ) . These patients were r and omly assigned to either the main building or the east building of our hospital . In the main building 38 patients were looked after using traditional practice ( control group ) . In the east building 47 patients were looked after according to the clinical pathway ( path group ) and 2 patients were excluded from the path group because of neo-adjuvant chemotherapy and severe heart failure . Aspects of the patients ' outcomes , including length of stay , the first day of the diet , morbidity , and medical costs , were compared between the path group and the control group . All data were expressed as means+/-st and ard deviation . Statistical analyses were made using Student t-test , Mann-Whitney U-test , and chi(2 ) test , and the 5%level was chosen for statistical significance . RESULTS The length of the hospital stay was 27.1+/-10.0 and 40.8+/-26.1 days ( p<0.005 ) and the length of post-operative stay was 18.1+/-9.5 and 28.2+/-22.3 days ( p<0.01 ) in the path group and the control group , respectively . The post-operative day when the diet was started for the path and control groups was 6.8+/-8.9 and 8.2+/-7.2 , respectively ; however , the length of the intravenous infusion for the two groups was 11.8+/-1.1 and 16.5+/-1.2 days ( p<0.01 ) , respectively . There was no statistically significant difference in the morbidity rate between the path group ( 3/47 ) and the control group ( 5/38 ) . The total cost was 1,502,587 yen + /-41,650 in the path group and 1,932,197 yen + /-131,030 in the control ( p<0.001 ) . CONCLUSION A clinical pathway for gastrectomy patients proved useful to optimize their postoperative care , including medication management and diet education . It is suggested that the implementation of a st and ardized clinical pathway for gastrectomy patients reduced the length of the hospital stay and the medical costs OBJECTIVE Because of recent increases in health care costs , cost containment has become a important issue in medical practice . We evaluated the effect on cost and clinical outcome with the implementation of clinical care pathway for transurethral resection of the prostate ( TURP ) patients . MATERIAL S & METHODS Our series consists of 69 consecutive patients treated with TURP between June 1 , 1999 and March 31 , 2000 . The patients were divided into two groups at r and om . Thirty-two patients were treated on the clinical pathway ( pathway group ) and 37 patients were not placed on the clinical pathway program ( non-pathway group ) . Total hospital charges , average length of stay and clinical outcomes were compared in two groups . RESULTS The average of total hospital charges ( insurance points ) and average length of stay were 48,424.2 point , and 12.7 days for the pathway group , and 55.365.5 point , and 14.7 days for non-pathway group respectively . Postoperative complications and rehospitalization did not differ between two groups . DISCUSSION With the implementation of the clinical care pathway , average hospital charges and length of stay were reduced . The clinical pathway program is considered to be a good tool for health care cost management . This methodology can be applied to all patients . However , when we make the clinical pathway program , we take into account the individuality of each patients Abstract INTRODUCTION : In an era of dwindling hospital re sources and increasing medical costs , safe reduction in postoperative stay has become a major focus to optimize utilization of healthcare re sources . Although several protocol s have been reported to reduce postoperative stay , no Level I evidence exists for their use in routine clinical practice . METHODS : Sixty-four patients undergoing laparotomy and intestinal or rectal resection were r and omly assigned to a pathway of controlled rehabilitation with early ambulation and diet or to traditional postoperative care . Time to discharge from hospital , complication and readmission rates , pain level , quality of life , and patient satisfaction scores were determined at the time of discharge and at 10 and 30 days after surgery . Subgroups were defined to evaluate those who derived the optimal benefit from the protocol . RESULTS : Pathway patients spent less total time in the hospital after surgery ( 5.4 vs. 7.1 days ; P = 0.02 ) and less time in the hospital during the primary admission than traditional patients . Patients younger than 70 years old had greater benefits than the overall study group ( 5 vs. 7.1 days ; P = 0.01 ) . Patients treated by surgeons with the most experience with the pathway spent significantly less time in the hospital than did those whose surgeons were less experienced with the pathway ( P = 0.01 ) . There was no difference between pathway and traditional patients for readmission or complication rates , pain score , quality of life after surgery , or overall satisfaction with the hospital stay . CONCLUSIONS : Patients scheduled for a laparotomy and major intestinal or rectal resection are suitable for management by a pathway of controlled rehabilitation with early ambulation and diet . Pathway patients have a shorter hospital stay , with no adverse effect on patient satisfaction , pain scores , or complication rates . Patients younger than 70 years of age derive the optimal benefit , and increased surgeon experience improves outcome Background . Clinical pathways for asthma are tools that have the potential to improve compliance with nationally recognized management guidelines , but their effect on patient outcomes has not been
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| The aim of this study was to identify the circumstances in which ICPs are effective , for whom and in what context s. Methods A systematic review of high- quality r and omised controlled trials published between 1980 and 2008 ( March ) evaluating ICP use in child and adult population s in the full range of healthcare setting s. RESULTS 1 For relatively predictable trajectories of care ICPs can be effective in supporting proactive care management and ensuring that patients receive relevant clinical interventions and /or assessment s in a timely manner .
This can lead to improvements in service quality and service efficiency without adverse consequences for patients .
2 ICPs are an effective mechanism for promoting adherence to guidelines or treatment protocol s thereby reducing variation in practice .
3 ICPs can be effective in improving documentation of treatment goals , documentation of communication with patients , carers and health professionals .
4 ICPs can be effective in improving physician agreement about treatment options .
5 ICPs can be effective in supporting decision-making when they incorporate a decision-aide .
6 The evidence considered in this review indicates that ICPs may be particularly effective in changing professional behaviours in the desired direction , where there is scope for improvement or where roles are new .
7 Even in context s in which health professionals are already experienced with a particular pathway , ICP use brings additional beneficial effects in directing professional practice in the desired direction .
8 ICPs may be less effective in bringing about service quality and efficiency gains in variable patient trajectories .
9 ICPs may be less effective in bringing about quality improvements in circumstances in which services are already based on best evidence and multidisciplinary working is well established .
10 Depending on their purpose , the benefits of ICPs may be greater for certain patient subgroups than others .
11 We do not know whether the costs of ICP development and implementation are justified by any of their reported benefits .
12 ICPs may need supporting mechanisms to underpin their implementation and ensure their adoption in practice , particularly in circumstances in which ICP use is a significant change in organisational culture .
13 ICP documentation can introduce scope for new kinds of error .
Conclusions ICPs are most effective in context s where patient care trajectories are predictable .
Their value in setting s in which recovery pathways are more variable is less clear .
ICPs are most effective in bringing about behavioural changes where there are identified deficiencies in services ; their value in context s where inter-professional working is well established is less certain . |
MS211612 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE To test the effects of two Mediterranean diet ( MedDiet ) interventions versus a low-fat diet on incidence of diabetes . RESEARCH DESIGN AND METHODS This was a three-arm r and omized trial in 418 nondiabetic subjects aged 55–80 years recruited in one center ( PREDIMED-Reus , northeastern Spain ) of the Prevención con Dieta Mediterránea [ PREDIMED ] study , a large nutrition intervention trial for primary cardiovascular prevention in individuals at high cardiovascular risk . Participants were r and omly assigned to education on a low-fat diet ( control group ) or to one of two MedDiets , supplemented with either free virgin olive oil ( 1 liter/week ) or nuts ( 30 g/day ) . Diets were ad libitum , and no advice on physical activity was given . The main outcome was diabetes incidence diagnosed by the 2009 American Diabetes Association criteria . RESULTS After a median follow-up of 4.0 years , diabetes incidence was 10.1 % ( 95 % CI 5.1–15.1 ) , 11.0 % ( 5.9–16.1 ) , and 17.9 % ( 11.4–24.4 ) in the MedDiet with olive oil group , the MedDiet with nuts group , and the control group , respectively . Multivariable adjusted hazard ratios of diabetes were 0.49 ( 0.25–0.97 ) and 0.48 ( 0.24–0.96 ) in the MedDiet supplemented with olive oil and nuts groups , respectively , compared with the control group . When the two MedDiet groups were pooled and compared with the control group , diabetes incidence was reduced by 52 % ( 27–86 ) . In all study arms , increased adherence to the MedDiet was inversely associated with diabetes incidence . Diabetes risk reduction occurred in the absence of significant changes in body weight or physical activity . CONCLUSIONS MedDiets without calorie restriction seem to be effective in the prevention of diabetes in subjects at high cardiovascular risk Aims /hypothesisThe role of diet in the prevention of diabetes remains uncertain . The aim of this study was to investigate two different dietary aspects , i.e. adherence to the Mediterranean diet and glycaemic load ( GL ) , in relation to diabetes occurrence . Methods We analysed data from the Greek cohort of the population -based European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) . From a total of 22,295 participants , actively followed for a median of 11.34 years , 2,330 cases of incident type 2 diabetes were recorded . All participants completed a vali date d , interviewer-administered semi-quantitative food frequency question naire at enrolment . From this information , we calculated a ten point Mediterranean diet score ( MDS ) , reflecting adherence to the traditional Mediterranean diet , as well as the dietary GL . We estimated HRs and the corresponding 95 % CIs of diabetes using Cox proportional hazards regression models adjusted for potential confounders . Results A higher MDS was inversely associated with diabetes risk ( HR 0.88 [ 95 % CI 0.78 , 0.99 ] for MDS ≥6 vs MDS ≤3 ) . GL was positively associated with diabetes ( HR 1.21 [ 95 % CI 1.05 , 1.40 ] for the highest vs the lowest GL quartile ) . A significant protection of about 20 % was found for a diet with a high MDS and a low GL . Conclusions /interpretationA low GL diet that also adequately adheres to the principles of the traditional Mediterranean diet may reduce the incidence of type 2 diabetes Background Hypertension can be prevented by adopting healthy dietary patterns . Our aim was to assess the 4-year effect on blood pressure ( BP ) control of a r and omized feeding trial promoting the traditional Mediterranean dietary pattern . Methods The PREDIMED primary prevention trial is a r and omized , single-blinded , controlled trial conducted in Spanish primary healthcare centers . We recruited 7,447 men ( aged 55 to 80 years ) and women ( aged 60 to 80 years ) who had high risk for cardiovascular disease . Participants were assigned to a control group or to one of two Mediterranean diets . The control group received education on following a low-fat diet , while the groups on Mediterranean diets received nutritional education and also free foods ; either extra virgin olive oil , or nuts . Trained personnel measured participants ’ BP at baseline and once yearly during a 4-year follow-up . We used generalized estimating equations to assess the differences between groups during the follow-up . Results The percentage of participants with controlled BP increased in all three intervention groups ( P-value for within-group changes : P<0.001 ) . Participants allocated to either of the two Mediterranean diet groups had significantly lower diastolic BP than the participants in the control group ( −1.53 mmHg ( 95 % confidence interval ( CI ) −2.01 to −1.04 ) for the Mediterranean diet supplemented with extra virgin olive oil , and −0.65 mmHg ( 95 % CI -1.15 to −0.15 ) mmHg for the Mediterranean diet supplemented with nuts ) . No between-group differences in changes of systolic BP were seen . Conclusions Both the traditional Mediterranean diet and a low-fat diet exerted beneficial effects on BP and could be part of advice to patients for controlling BP . However , we found lower values of diastolic BP in the two groups promoting the Mediterranean diet with extra virgin olive oil or with nuts than in the control group . Trial registration Current Controlled Trials IS RCT BACKGROUND Adherence to the Mediterranean diet ( Med-Diet ) is associated with a reduced risk of cardiovascular disease ( CVD ) . However , the molecular mechanisms involved are not fully understood . OBJECTIVE The objective was to compare the effects of 2 Med-Diets with those of a low-fat diet on immune cell activation and soluble inflammatory biomarkers related to atherogenesis in subjects at high risk of CVD . DESIGN In a controlled study , we r and omly assigned 112 older subjects with diabetes or > or =3 CVD risk factors to 3 dietary intervention groups : Med-Diet with supplemental virgin olive oil ( VOO ) , Med-Diet with supplemental nuts , and low-fat diet . Changes from baseline in cellular and serum inflammatory biomarkers were assessed at 3 mo . RESULTS One hundred six participants ( 43 % women ; average age : 68 y ) completed the study . At 3 mo , monocyte expression of CD49d , an adhesion molecule crucial for leukocyte homing , and of CD40 , a proinflammatory lig and , decreased ( P < 0.05 ) after both Med-Diets but not after the low-fat diet . Serum interleukin-6 and soluble intercellular adhesion molecule-1 , inflammatory mediators crucial in firm adhesion of leukocytes to endothelial surfaces , decreased ( P < 0.05 ) in both Med-Diet groups . Soluble vascular cellular adhesion molecule-1 and C-reactive protein decreased only after the Med-Diet with VOO ( P < 0.05 ) , whereas interleukin-6 , soluble vascular cellular adhesion molecule-1 , and soluble intercellular adhesion molecule-1 increased ( P < 0.05 ) after the low-fat diet . CONCLUSIONS Med-Diets supplemented with VOO or nuts down-regulate cellular and circulating inflammatory biomarkers related to atherogenesis in subjects at high risk of CVD . The results support the recommendation of the Med-Diet as a useful tool against CVD & NA;The PREvención con DIeta MEDiterránea ( PREDIMED ) trial showed that Mediterranean diets ( MedDiets ) supplemented with either extravirgin olive oil or nuts reduced cardiovascular events , particularly stroke , compared with a control , lower fat diet . The mechanisms of cardiovascular protection remain unclear . We evaluated the 1-year effects of supplemented MedDiets on 24-hour ambulatory blood pressure ( BP ) , blood glucose , and lipids . R and omized , parallel- design , controlled trial was conducted in 2 PREDIMED sites . Diets were ad libitum , and no advice on increasing physical activity or reducing sodium intake was given . Participants were 235 subjects ( 56.5 % women ; mean age , 66.5 years ) at high cardiovascular risk ( 85.4 % with hypertension ) . Adjusted changes from baseline in mean systolic BP were −2.3 ( 95 % confidence interval [ CI ] , −4.0 to −0.5 ) mm Hg and −2.6 ( 95 % CI , −4.3 to −0.9 ) mm Hg in the MedDiets with olive oil and the MedDiets with nuts , respectively , and 1.7 ( 95 % CI , −0.1 to 3.5 ) mm Hg in the control group ( P<0.001 ) . Respective changes in mean diastolic BP were −1.2 ( 95 % CI , −2.2 to −0.2 ) , −1.2 ( 95 % CI , −2.2 to −0.2 ) , and 0.7 ( 95 % CI , −0.4 to 1.7 ) mm Hg ( P=0.017 ) . Daytime and nighttime BP followed similar patterns . Mean changes from baseline in fasting blood glucose were −6.1 , −4.6 , and 3.5 mg/dL ( P=0.016 ) in the MedDiets with olive oil , MedDiets with nuts , and control diet , respectively ; those of total cholesterol were −11.3 , −13.6 , and −4.4 mg/dL ( P=0.043 ) , respectively . In high-risk individuals , most with treated hypertension , MedDiets supplemented with extravirgin olive oil or nuts reduced 24-hour ambulatory BP , total cholesterol , and fasting glucose . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : IS RCT N35739639 Context Some experts attribute a low incidence of heart disease in Mediterranean countries to dietary habits . Contribution In this multicenter , 3-group trial , investigators r and omly assigned 772 adults at high risk for cardiovascular disease to a low-fat diet or to a Mediterranean diet supplemented with either virgin olive oil ( 1 L per week ) or nuts ( 30 g per day ) . After 3 months , the Mediterranean diet groups had lower mean plasma glucose level , systolic blood pressure , and total cholesterolhigh-density lipoprotein cholesterol ratio than the low-fat diet group . Caution s The Mediterranean diet groups received more nutritional education than the low-fat diet group . Implication s Mediterranean diets supplemented with olive oil or nuts may improve cardiovascular risk factors . The Editors Cardiovascular disease is the main cause of death in industrialized countries , but incidence rates have marked geographic differences . The low incidence of coronary heart disease ( CHD ) in Mediterranean countries has been partly ascribed to dietary habits ( 1 - 3 ) . Recent findings from large European cohort studies ( 4 - 6 ) suggest that a high degree of adherence to the Mediterranean diet is associated with a reduction in mortality . In small clinical studies , the Mediterranean diet or some of its components have reduced blood pressure ( 7 ) and have improved lipid profiles ( 8 , 9 ) and endothelial function ( 10 ) . Moreover , a recent cross-sectional study ( 11 ) and a 2-year feeding trial ( 12 ) have shown that adherence to the Mediterranean diet is associated with reduced markers of vascular inflammation . These beneficial effects on surrogate markers of cardiovascular risk add biological plausibility to the epidemiologic evidence that supports a protective effect of the Mediterranean diet . Olive oil , a rich source of monounsaturated fatty acids , is a main component of the Mediterranean diet . Virgin olive oil retains all the lipophilic components of the fruit , -tocopherol , and phenolic compounds with strong antioxidant and anti-inflammatory properties ( 13 , 14 ) . Tree nuts , which are also typical in the Mediterranean diet , have a favorable fatty acid profile and are a rich source of nutrients and other bioactive compounds that may beneficially influence the risk for CHD , such as fiber , phytosterols , folic acid , and antioxidants ( 15 ) . Frequent nut intake has been associated with decreased CHD rates in prospect i ve studies ( 15 ) . Walnuts differ from all other nuts through their high content of polyunsaturated fatty acids , particularly -linolenic acid , a plant n-3 fatty acid ( 16 ) , which may confer additional antiatherogenic properties ( 17 ) . Therefore , we design ed a large-scale feeding trial in high-risk participants to assess the effects of 2 Mediterranean diets , one supplemented with virgin olive oil and the other supplemented with mixed nuts , compared with a low
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| The results of the PREDIMED study , a r and omized trial providing a higher level of scientific evidence than cohort studies , confirmed that the Mediterranean diet reduces the incidence of cardiovascular events .
This effect may be exerted by reducing blood pressure ; improving glucose metabolism , lipid profile , and lipoprotein particle characteristics ; and decreasing inflammation and oxidative stress .
It may also stem from a favorable interaction between diet and gene polymorphisms related to cardiovascular risk factors and events . |
MS211613 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: CONTEXT Many observational studies have shown that physical activity reduces the risk of cognitive decline ; however , evidence from r and omized trials is lacking . OBJECTIVE To determine whether physical activity reduces the rate of cognitive decline among older adults at risk . DESIGN AND SETTING R and omized controlled trial of a 24-week physical activity intervention conducted between 2004 and 2007 in metropolitan Perth , Western Australia . Assessors of cognitive function were blinded to group membership . PARTICIPANTS We recruited volunteers who reported memory problems but did not meet criteria for dementia . Three hundred eleven individuals aged 50 years or older were screened for eligibility , 89 were not eligible , and 52 refused to participate . A total of 170 participants were r and omized and 138 participants completed the 18-month assessment . INTERVENTION Participants were r and omly allocated to an education and usual care group or to a 24-week home-based program of physical activity . MAIN OUTCOME MEASURE Change in Alzheimer Disease Assessment Scale-Cognitive Subscale ( ADAS-Cog ) scores ( possible range , 0 - 70 ) over 18 months . RESULTS In an intent-to-treat analysis , participants in the intervention group improved 0.26 points ( 95 % confidence interval , -0.89 to 0.54 ) and those in the usual care group deteriorated 1.04 points ( 95 % confidence interval , 0.32 to 1.82 ) on the ADAS-Cog at the end of the intervention . The absolute difference of the outcome measure between the intervention and control groups was -1.3 points ( 95 % confidence interval,-2.38 to -0.22 ) at the end of the intervention . At 18 months , participants in the intervention group improved 0.73 points ( 95 % confidence interval , -1.27 to 0.03 ) on the ADAS-Cog , and those in the usual care group improved 0.04 points ( 95 % confidence interval , -0.46 to 0.88 ) . Word list delayed recall and Clinical Dementia Rating sum of boxes improved modestly as well , whereas word list total immediate recall , digit symbol coding , verbal fluency , Beck depression score , and Medical Outcomes 36-Item Short-Form physical and mental component summaries did not change significantly . CONCLUSIONS In this study of adults with subjective memory impairment , a 6-month program of physical activity provided a modest improvement in cognition over an 18-month follow-up period . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12605000136606 Objective : To study the influence of leisure activity participation on risk of development of amnestic mild cognitive impairment ( aMCI ) . Methods : The authors examined the relationship between baseline level of participation in leisure activities and risk of aMCI in a prospect i ve cohort of 437 community-residing subjects older than 75 years , initially free of dementia or aMCI , using Cox analysis adjusted for age , sex , education , and chronic illnesses . The authors derived Cognitive and Physical Activity Scales based on frequency of participation in individual activities . Results : Over a median follow-up of 5.6 years , 58 subjects had development of aMCI . A one-point increase on the Cognitive ( hazard ratio [ HR ] 0.95 , 95 % CI 0.91 to 0.99 ) but not Physical Activities Scale ( HR 0.97 , 95 % CI 0.93 to 1.01 ) was associated with lower risk of aMCI . Subjects with Cognitive Activity scores in the highest ( HR 0.46 , 95 % CI 0.24 to 0.91 ) and middle thirds ( HR 0.52 , 95 % CI 0.29 to 0.96 ) had a lower risk of aMCI compared with subjects in the lowest third . The association persisted even after excluding subjects who converted to dementia within 2 years of meeting criteria for aMCI . Conclusions : Cognitive activity participation is associated with lower risk of development of amnestic mild cognitive impairment , even after excluding individuals at early stages of dementia BACKGROUND Participation in leisure activities has been associated with a lower risk of dementia . It is unclear whether increased participation in leisure activities lowers the risk of dementia or participation in leisure activities declines during the pre clinical phase of dementia . METHODS We examined the relation between leisure activities and the risk of dementia in a prospect i ve cohort of 469 subjects older than 75 years of age who resided in the community and did not have dementia at base line . We examined the frequency of participation in leisure activities at enrollment and derived cognitive-activity and physical-activity scales in which the units of measure were activity-days per week . Cox proportional-hazards analysis was used to evaluate the risk of dementia according to the base-line level of participation in leisure activities , with adjustment for age , sex , educational level , presence or absence of chronic medical illnesses , and base-line cognitive status . RESULTS Over a median follow-up period of 5.1 years , dementia developed in 124 subjects ( Alzheimer 's disease in 61 subjects , vascular dementia in 30 , mixed dementia in 25 , and other types of dementia in 8) . Among leisure activities , reading , playing board games , playing musical instruments , and dancing were associated with a reduced risk of dementia . A one-point increment in the cognitive-activity score was significantly associated with a reduced risk of dementia ( hazard ratio , 0.93 [ 95 percent confidence interval , 0.90 to 0.97 ] ) , but a one-point increment in the physical-activity score was not ( hazard ratio , 1.00 ) . The association with the cognitive-activity score persisted after the exclusion of the subjects with possible pre clinical dementia at base line . Results were similar for Alzheimer 's disease and vascular dementia . In linear mixed models , increased participation in cognitive activities at base line was associated with reduced rates of decline in memory . CONCLUSIONS Participation in leisure activities is associated with a reduced risk of dementia , even after adjustment for base-line cognitive status and after the exclusion of subjects with possible pre clinical dementia . Controlled trials are needed to assess the protective effect of cognitive leisure activities on the risk of dementia CONTEXT Evidence suggests that physical activity may be related to the clinical expression of dementia . Whether the association includes low-intensity activity such as walking is not known . OBJECTIVE To examine the association between walking and future risk of dementia in older men . DESIGN Prospect i ve cohort study . SETTING AND PARTICIPANTS Distance walked per day was assessed from 1991 to 1993 in 2257 physically capable men aged 71 to 93 years in the Honolulu-Asia Aging Study . Follow-up for incident dementia was based on neurological assessment at 2 repeat examinations ( 1994 - 1996 and 1997 - 1999 ) . MAIN OUTCOME MEASURES Overall dementia , Alzheimer disease , and vascular dementia . RESULTS During the course of follow-up , 158 cases of dementia were identified ( 15.6/1000 person-years ) . After adjusting for age , men who walked the least ( < 0.25 mile/d ) experienced a 1.8-fold excess risk of dementia compared with those who walked more than 2 mile/d ( 17.8 vs 10.3/1000 person-years ; relative hazard [ RH ] , 1.77 ; 95 % confidence interval [ CI ] , 1.04 - 3.01 ) . Compared with men who walked the most ( > 2 mile/d ) , an excess risk of dementia was also observed in those who walked 0.25 to 1 mile/d ( 17.6 vs 10.3/1000 person-years ; RH , 1.71 ; 95 % CI , 1.02 - 2.86 ) . These associations persisted after accounting for other factors , including the possibility that limited amounts of walking could be the result of a decline in physical function due to pre clinical dementia . CONCLUSIONS Findings suggest that walking is associated with a reduced risk of dementia . Promoting active lifestyles in physically capable men could help late-life cognitive function Relative risk among exposure groups in prospect i ve cohort studies is based on the assumption that all subjects are exposed at the level recorded at baseline throughout the study . Changes in risk behavior during follow-up will dilute the relative risk . This prospect i ve cohort study in Copenhagen , Denmark , between 1964 and 1994 included 30,640 men and women ; 19,149 were examined twice , with an interval of 6.7 ( st and ard deviation , 3.4 ) years . Relative risks calculated from baseline measurements for moderately active and sedentary groups compared with the highly active group were 1.11 ( 95 % confidence interval : 1.05 , 1.18 ) and 1.64 ( 95 % confidence interval : 1.53 , 1.75 ) , respectively . The relative risk between the highly active group and the sedentary group decreased with increasing follow-up time . When intraindividual changes in physical activity level during follow-up were taken into account , the relative risk of physical inactivity was 24 - 59 % higher compared with the relative risk estimated from baseline measurements . The risk of a sedentary lifestyle is underestimated when it is calculated from one baseline measurement in prospect i ve studies , because subjects change behavior during follow-up Objective : This study evaluated the protective role of physical activity ( PA ) against cognitive impairment ( CI ) in the oldest old ( age ≥ 85 ) . Method : Prospect i ve data on 66 optimally healthy , oldest old adults ( mean age 88.5 ) were analyzed using survival analysis . Results : In all , 12 men and 11 women reported exercising > 4 hours per week , and 38 participants developed CI ( mean onset age 93 ; mean follow-up 4.7 years ) . The effect of exercise was modified by gender . In more active women ( > 4 hours/week ) , the risk of CI was reduced by 88 % ( 95 % confidence interval 0.03 , 0.41 ) compared to those less active . Less active women had 2 times the incidence rate of CI compared to less active men and almost 5 times the rate compared to active women . Discussion : This study demonstrates the beneficial effects of exercise on healthy brain aging even in the oldest old and emphasizes the importance of increasing PA in older women BACKGROUND Cognitive impairment that does not meet the criteria for dementia ( " Cognitive Impairment , No Dementia " -- CIND ) is a heterogeneous category with an increased risk of dementia . While greater physical activity is generally associated with a lower odds of both dementia and CIND , whether this effect applies across subgroups is not known . OBJECTIVES To investigate the association between physical activity and the risk of vascular CIND ( VCI-ND ) or mild cognitive impairment ( MCI ) . METHODS In the Canadian Study of Health and Aging community-dwelling cohort , of 4683 people who were not impaired at baseline , 3945 remained without cognitive impairment at 5 years , 454 were diagnosed with CIND , and 284 with dementia . Incident CIND and VCI-ND ( n=163 ) and MCI ( n=100 ) subtypes were investigated in relation to baseline physical activity , stratified by sex . RESULTS In women , moderate-high exercise was associated with a lower odds of CIND ( OR=0.62 , 95 % CI=0.46 - 0.84 ) and VCI-ND ( 0.34 , 0.18 - 0.63 ) relative to low exercise . There was no association for men or for MCI . CONCLUSION Exercise appears to reduce the risk of VCI-ND in women . Whether the lack of an effect of exercise on the odds of MCI reflects that ' prevented AD ' is indistinguishable from MCI is an intriguing possibility that merits further study CONTEXT Dementia is common , costly , and highly age related . Little attention has been paid to the identification of modifiable lifestyle habits for its prevention . OBJECTIVE To explore the association between physical activity and the risk of cognitive impairment and dementia . DESIGN , SETTING , AND SUBJECTS Data come from a community sample of 9008 r and omly selected men and women 65 years or older , who were evaluated in the 1991 - 1992 Canadian Study of Health and Aging , a prospect i ve cohort study of dementia . Of the 6434 eligible subjects who were cognitively normal at baseline , 4615 completed a 5-year follow-up . Screening and clinical evaluations were done at both waves of the study . In 1996 - 1997 , 3894 remained without cognitive impairment , 436 were diagnosed as having cognitive impairment-no dementia , and 285 were diagnosed as having dementia . MAIN OUTCOME MEASURE Incident cognitive impairment and dementia by levels of physical activity at baseline . RESULTS Compared with no exercise , physical activity was associated with lower risks of cognitive impairment , Alzheimer disease , and dementia of any type . Significant trends for increased protection with greater physical activity were observed . High levels of physical activity were associated with reduced risks of cognitive impairment ( age- , sex- , and education-adjusted odds ratio , 0.5
Output:
| Conclusions : We conclude that there is evidence supporting the hypothesis that physical activity is likely to prevent the development of VaD , and should be highlighted as part of secondary prevention programmes in people at risk for cerebrovascular disease |
MS211614 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE The aim of this work is to provide a supervised method to assist the diagnosis and monitor the progression of the Alzheimer 's disease ( AD ) using information which can be extracted from a functional magnetic resonance imaging ( fMRI ) experiment . METHODS AND MATERIAL S The proposed method consists of five stages : ( a ) preprocessing of fMRI data , ( b ) modeling of the fMRI voxel time series using a generalized linear model , ( c ) feature extraction from the fMRI experiment , ( d ) feature selection , and ( e ) classification using the r and om forests algorithm . In the last stage we employ features that were extracted from the fMRI and other features such as demographics , behavioral and volumetric measures . The aim of the classification is twofold : first to diagnose AD and second to classify AD as very mild and mild . RESULTS The method is evaluated using data from 41 subjects . The stage of AD is established using the Washington University Alzheimer 's Disease Research Center recruitment and assessment procedures . The method classifies a patient as healthy or demented with 84 % sensitivity and 92.3 % specificity , and the stages of AD with 81 % and 87 % accuracy for the three class and the four class problem , respectively . CONCLUSIONS The method is advantageous since it is fully automated and for the first time the diagnosis and staging of the disease are addressed using fMRI Individuals with developmental dyslexia vary in their ability to improve reading skills , but the brain basis for improvement remains largely unknown . We performed a prospect i ve , longitudinal study over 2.5 y in children with dyslexia ( n = 25 ) or without dyslexia ( n = 20 ) to discover whether initial behavioral or brain measures , including functional MRI ( fMRI ) and diffusion tensor imaging ( DTI ) , can predict future long-term reading gains in dyslexia . No behavioral measure , including widely used and st and ardized reading and language tests , reliably predicted future reading gains in dyslexia . Greater right prefrontal activation during a reading task that dem and ed phonological awareness and right superior longitudinal fasciculus ( including arcuate fasciculus ) white-matter organization significantly predicted future reading gains in dyslexia . Multivariate pattern analysis ( MVPA ) of these two brain measures , using linear support vector machine ( SVM ) and cross-validation , predicted significantly above chance ( 72 % accuracy ) which particular child would or would not improve reading skills ( behavioral measures were at chance ) . MVPA of whole-brain activation pattern during phonological processing predicted which children with dyslexia would improve reading skills 2.5 y later with > 90 % accuracy . These findings identify right prefrontal brain mechanisms that may be critical for reading improvement in dyslexia and that may differ from typical reading development . Brain measures that predict future behavioral outcomes ( neuroprognosis ) may be more accurate , in some cases , than available behavioral measures Successful automated diagnoses of attention deficit hyperactive disorder ( ADHD ) using imaging and functional biomarkers would have fundamental consequences on the public health impact of the disease . In this work , we show results on the predictability of ADHD using imaging biomarkers and discuss the scientific and diagnostic impacts of the research . We created a prediction model using the l and mark ADHD 200 data set focusing on resting state functional connectivity ( rs-fc ) and structural brain imaging . We predicted ADHD status and subtype , obtained by behavioral examination , using imaging data , intelligence quotients and other covariates . The novel contributions of this manuscript include a thorough exploration of prediction and image feature extraction methodology on this form of data , including the use of singular value decompositions ( SVDs ) , CUR decompositions , r and om forest , gradient boosting , bagging , voxel-based morphometry , and support vector machines as well as important insights into the value , and potentially lack thereof , of imaging biomarkers of disease . The key results include the CUR-based decomposition of the rs-fc-fMRI along with gradient boosting and the prediction algorithm based on a motor network parcellation and r and om forest algorithm . We conjecture that the CUR decomposition is largely diagnosing common population directions of head motion . Of note , a byproduct of this research is a potential automated method for detecting subtle in-scanner motion . The final prediction algorithm , a weighted combination of several algorithms , had an external test set specificity of 94 % with sensitivity of 21 % . The most promising imaging biomarker was a correlation graph from a motor network parcellation . In summary , we have undertaken a large-scale statistical exploratory prediction exercise on the unique ADHD 200 data set . The exercise produced several potential leads for future scientific exploration of the neurological basis of ADHD Functional magnetic resonance imaging ( fMRI ) of default mode network ( DMN ) brain activity during resting is recently gaining attention as a potential noninvasive biomarker to diagnose incipient Alzheimer 's disease . The aim of this study was to determine which method of data processing provides highest diagnostic power and to define metrics to further optimize the diagnostic value . fMRI was acquired in 21 healthy subjects , 17 subjects with mild cognitive impairment and 15 patients with Alzheimer 's disease ( AD ) and data evaluated both with volumes of interest (VOI)-based signal time course evaluations and independent component analyses ( ICA ) . The first approach determines the amount of DMN region interconnectivity ( as expressed with correlation coefficients ) ; the second method determines the magnitude of DMN coactivation . Apolipoprotein E ( ApoE ) genotyping was available in 41 of the subjects examined . Diagnostic power ( expressed as accuracy ) of data of a single DMN region in independent component analyses was 64 % , that of a single correlation of time courses between 2 DMN regions was 71 % , respectively . With multivariate analyses combining both methods of analysis and data from various regions , accuracy could be increased to 97 % ( sensitivity 100 % , specificity 95 % ) . In nondemented subjects , no significant differences in activity within DMN could be detected comparing ApoE ε4 allele carriers and ApoE ε4 allele noncarriers . However , there were some indications that fMRI might yield useful information given a larger sample . Time course correlation analyses seem to outperform independent component analyses in the identification of patients with Alzheimer 's disease . However , multivariate analyses combining both methods of analysis by considering the activity of various parts of the DMN as well as the interconnectivity between these regions are required to achieve optimal and clinical ly acceptable diagnostic power The functional neuroanatomy of verbal working memory is a potential diagnostic biomarker for depression . Twenty patients with unipolar depression and 20 healthy controls performed a variable load version ( n-back ) of the task . Functional MRI data were analysed with support vector machine methods . Diagnostic classification was highest at the mid-level of task difficulty ( 2-back ) ( sensitivity 65 % , specificity 70 % , P<0.009 ) . Significant classification of clinical response ( ≥50 % reduction in clinical symptom ratings ) was found at the most difficult level ( 3-back ) ( sensitivity 85 % , specificity 52 % , P<0.003 ) . The functional neuroanatomy of verbal working memory provides a statistically significant but clinical ly moderate contribution as a diagnostic biomarker for depression , whereas its potential as a neural predictor of clinical response requires further investigation This paper presents a discriminative model of multivariate pattern classification , based on functional magnetic resonance imaging ( fMRI ) and anatomical template . As a measure of brain function , Regional homogeneity ( ReHo ) is calculated voxel by voxel , and then a widely used anatomical template is applied on ReHo map to parcelate it into 116 brain regions . The mean and st and ard deviation of ReHo values in each region are extracted as features . Pseudo-Fisher Linear Discriminant Analysis ( PFLDA ) is performed for training sample s to generate discriminative model . Classification experiments have been carried out in 48 schizophrenia patients and 35 normal controls . Under a full leave-one-out ( LOO ) cross-validation , correct prediction rate of 80 % is achieved . Anatomical parcellation process is proved useful to improve classification rate by a control experiment . The discriminative model shows its ability to reveal abnormal brain functional activities and identify people with schizophrenia Stimulant and non-stimulant drugs can reduce symptoms of attention deficit/hyperactivity disorder ( ADHD ) . The stimulant drug methylpheni date ( MPH ) and the non-stimulant drug atomoxetine ( ATX ) are both widely used for ADHD treatment , but their differential effects on human brain function remain unclear . We combined event-related fMRI with multivariate pattern recognition to characterize the effects of MPH and ATX in healthy volunteers performing a rewarded working memory ( WM ) task . The effects of MPH and ATX on WM were strongly dependent on their behavioral context . During non-rewarded trials , only MPH could be discriminated from placebo ( PLC ) , with MPH producing a similar activation pattern to reward . During rewarded trials both drugs produced the opposite effect to reward , that is , attenuating WM networks and enhancing task-related deactivations ( TRDs ) in regions consistent with the default mode network ( DMN ) . The drugs could be directly discriminated during the delay component of rewarded trials : MPH produced greater activity in WM networks and ATX produced greater activity in the DMN . Our data provide evidence that : ( 1 ) MPH and ATX have prominent effects during rewarded WM in task-activated and -deactivated networks ; ( 2 ) during the delay component of rewarded trials , MPH and ATX have opposing effects on activated and deactivated networks : MPH enhances TRDs more than ATX , whereas ATX attenuates WM networks more than MPH ; and ( 3 ) MPH mimics reward during encoding . Thus , interactions between drug effects and motivational state are crucial in defining the effects of MPH and ATX This paper presents a new multigroup classification method based on subtle differences in regional brain activity during the completion of a functional magnetic resonance imaging ( fMRI ) challenge paradigm . Classification is performed based on features derived from BOLD time intensity curves in selected regions of interest ( ROI ) . For each ROI , a mean time intensity curve [ called mean regional response ( MRR ) ] is calculated from realigned and normalized data sets . The overall subject performance is characterized with a vector of features obtained using nonlinear modeling of all subject 's MRRs with a mixture of time shifted Gaussian functions . The classification is performed in the reduced-dimension optimal discrimination space , obtained through canonical transformations of original feature space . In order to demonstrate feasibility of the proposed method , classification of three groups of subjects is presented . The three groups are defined as heavy marijuana smokers after 24 hours of abstinence , heavy marijuana smokers after 28 days of abstinence , and healthy nonusing controls . The proposed method can be useful as an analytic tool for the discrimination of different groups of subjects based on temporal features of functional magnetic resonance imaging activation The aim of this work is to present an automated method that assists in the diagnosis of Alzheimer 's disease and also supports the monitoring of the progression of the disease . The method is based on features extracted from the data acquired during an fMRI experiment . It consists of six stages : ( a ) preprocessing of fMRI data , ( b ) modeling of fMRI voxel time series using a Generalized Linear Model , ( c ) feature extraction from the fMRI data , ( d ) feature selection , ( e ) classification using classical and improved variations of the R and om Forests algorithm and Support Vector Machines , and ( f ) conversion of the trees , of the R and om Forest , to rules which have physical meaning . The method is evaluated using a data set of 41 subjects . The results of the proposed method indicate the validity of the method in the diagnosis ( accuracy 94 % ) and monitoring of the Alzheimer 's disease ( accuracy 97 % and 99 % )
Output:
| There is some evidence that , in particular , support vector machines seem to be promising . |
MS211615 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective : Isotonic saline is the most commonly used crystalloid in the ICU , but recent evidence suggests that balanced fluids like Lactated Ringer ’s solution may be preferable . We examined the association between choice of crystalloids and in-hospital mortality during the resuscitation of critically ill adults with sepsis . Design : A retrospective cohort study of patients admitted with sepsis , not undergoing any surgical procedures , and treated in an ICU by hospital day 2 . We used propensity score matching to control for confounding and compared the following outcomes after resuscitation with balanced versus with no-balanced fluids : in-hospital mortality , acute renal failure with and without dialysis , and hospital and ICU lengths of stay . We also estimated the dose-response relationship between receipt of increasing proportions of balanced fluids and in-hospital mortality . Setting : Three hundred sixty U.S. hospitals that were members of the Premier Healthcare alliance between November 2005 and December 2010 . Patients : A total of 53,448 patients with sepsis , treated with vasopressors and crystalloids in an ICU by hospital day 2 including 3,396 ( 6.4 % ) that received balanced fluids . Interventions : None . Measurements and Main Results : Patients treated with balanced fluids were younger and less likely to have heart or chronic renal failure , but they were more likely to receive mechanical ventilation , invasive monitoring , colloids , steroids , and larger crystalloid volumes ( median 7 vs 5 L ) . Among 6,730 patients in a propensity-matched cohort , receipt of balanced fluids was associated with lower in-hospital mortality ( 19.6 % vs 22.8 % ; relative risk , 0.86 ; 95 % CI , 0.78 , 0.94 ) . Mortality was progressively lower among patients receiving larger proportions of balanced fluids . There were no significant differences in the prevalence of acute renal failure ( with and without dialysis ) or in-hospital and ICU lengths of stay . Conclusions : Among critically ill adults with sepsis , resuscitation with balanced fluids was associated with a lower risk of in-hospital mortality . If confirmed in r and omized trials , this finding could have significant public health implication s , as crystalloid resuscitation is nearly universal in sepsis BACKGROUND Both balanced crystalloids and saline are used for intravenous fluid administration in critically ill adults , but it is not known which results in better clinical outcomes . METHODS In a pragmatic , cluster‐r and omized , multiple‐crossover trial conducted in five intensive care units at an academic center , we assigned 15,802 adults to receive saline ( 0.9 % sodium chloride ) or balanced crystalloids ( lactated Ringer 's solution or Plasma‐Lyte A ) according to the r and omization of the unit to which they were admitted . The primary outcome was a major adverse kidney event within 30 days — a composite of death from any cause , new renal‐replacement therapy , or persistent renal dysfunction ( defined as an elevation of the creatinine level to ≥200 % of baseline ) — all censored at hospital discharge or 30 days , whichever occurred first . RESULTS Among the 7942 patients in the balanced‐crystalloids group , 1139 ( 14.3 % ) had a major adverse kidney event , as compared with 1211 of 7860 patients ( 15.4 % ) in the saline group ( marginal odds ratio , 0.91 ; 95 % confidence interval [ CI ] , 0.84 to 0.99 ; conditional odds ratio , 0.90 ; 95 % CI , 0.82 to 0.99 ; P=0.04 ) . In‐hospital mortality at 30 days was 10.3 % in the balanced‐crystalloids group and 11.1 % in the saline group ( P=0.06 ) . The incidence of new renal‐replacement therapy was 2.5 % and 2.9 % , respectively ( P=0.08 ) , and the incidence of persistent renal dysfunction was 6.4 % and 6.6 % , respectively ( P=0.60 ) . CONCLUSIONS Among critically ill adults , the use of balanced crystalloids for intravenous fluid administration result ed in a lower rate of the composite outcome of death from any cause , new renal‐replacement therapy , or persistent renal dysfunction than the use of saline . ( Funded by the V and erbilt Institute for Clinical and Translational Research and others ; SMART‐MED and SMART‐SURG Clinical Trials.gov numbers , NCT02444988 and NCT02547779 . BACKGROUND Normal saline ( NS ) is the most commonly used crystalloid solution worldwide but contains an excess of chloride and may cause metabolic acidosis and hyperchloraemia . Such abnormalities may be attenuated by the use of a balanced solution such as Plasma-Lyte 148 ( PL-148 ) . OBJECTIVE To assess the feasibility , safety and biochemical and physiological effects of resuscitation with NS versus PL-148 in critically ill patients . DESIGN , SETTING AND PARTICIPANTS An exploratory , multicentre , doubleblind , r and omised controlled trial involving patients aged ≥ 18 years who were prescribed crystalloid fluid resuscitation by the treating clinician between 16 July and 22 October 2015 , in three multidisciplinary intensive care units in Melbourne , Victoria , Australia . METHODS R and om allocation of NS or PL-148 was concealed , and all fluids were delivered in indistinguishable bags . INTERVENTION NS or PL-148 was administered for all fluid resuscitation and for all subsequent crystalloid fluid therapy until Day 4 of ICU admission . The treating intensivist determined the rate and frequency of fluid administration . MAIN OUTCOME MEASURES Primary outcome was daily base excess ( BE ) . Relevant secondary outcomes included the incidence of acute kidney injury ( AKI ) , change in serum creatinine and serum chloride levels , and mortality . RESULTS Seventy patients were recruited , with 34 in the NS group and 33 in the PL-148 group available for analysis . Baseline characteristics of study patients were well balanced ; the mean ages were 64 and 62 years , respectively , and nearly two-thirds of the patients in each group were men . The median Acute Physiology and Chronic Health Evaluation III scores were 64 for the NS group ( interquartile range [ IQR ] , 48 - 73 ) and 55 for the PL-148 group ( IQR , 44 - 81 ) . After treatment , there was no significant difference in the worst ( most negative ) median BE between the NS and PL-148 groups ( -4 mEq/L [ IQR , -7 to -2 mEq/L ] v -3 mEq/L [ IQR , -7 to 2 mEq/L ] ; P = 0.42 ) . Chloride levels were significantly higher with NS therapy ( median , 111 mmol/L [ IQR , 108 - 116 mmol/L ] v 108 mmol/L [ IQR , 106 - 110 mmol/L ] ; P = 0.01 ) . There was no significant difference in the incidence of AKI ( P = 0.48 ) , peak creatinine levels ( P = 0.92 ) or ICU or hospital mortality between the two groups . CONCLUSIONS In our exploratory , double-blind , r and omised controlled trial , when compared with NS , PL-148 did not significantly increase BE values in critically ill patients requiring fluid resuscitation , but decreased peak chloride concentrations CONTEXT Administration of traditional chloride-liberal intravenous fluids may precipitate acute kidney injury ( AKI ) . OBJECTIVE To assess the association of a chloride-restrictive ( vs chloride-liberal ) intravenous fluid strategy with AKI in critically ill patients . DESIGN , SETTING , AND PATIENTS Prospect i ve , open-label , sequential period pilot study of 760 patients admitted consecutively to the intensive care unit ( ICU ) during the control period ( February 18 to August 17 , 2008 ) compared with 773 patients admitted consecutively during the intervention period ( February 18 to August 17 , 2009 ) at a university-affiliated hospital in Melbourne , Australia . INTERVENTIONS During the control period , patients received st and ard intravenous fluids . After a 6-month phase-out period ( August 18 , 2008 , to February 17 , 2009 ) , any use of chloride-rich intravenous fluids ( 0.9 % saline , 4 % succinylated gelatin solution , or 4 % albumin solution ) was restricted to attending specialist approval only during the intervention period ; patients instead received a lactated solution ( Hartmann solution ) , a balanced solution ( Plasma-Lyte 148 ) , and chloride-poor 20 % albumin . MAIN OUTCOME MEASURES The primary outcomes included increase from baseline to peak creatinine level in the ICU and incidence of AKI according to the risk , injury , failure , loss , end-stage ( RIFLE ) classification . Secondary post hoc analysis outcomes included the need for renal replacement therapy ( RRT ) , length of stay in ICU and hospital , and survival . RESULTS Chloride administration decreased by 144 504 mmol ( from 694 to 496 mmol/patient ) from the control period to the intervention period . Comparing the control period with the intervention period , the mean serum creatinine level increase while in the ICU was 22.6 μmol/L ( 95 % CI , 17.5 - 27.7 μmol/L ) vs 14.8 μmol/L ( 95 % CI , 9.8 - 19.9 μmol/L ) ( P = .03 ) , the incidence of injury and failure class of RIFLE-defined AKI was 14 % ( 95 % CI , 11%-16 % ; n = 105 ) vs 8.4 % ( 95 % CI , 6.4%-10 % ; n = 65 ) ( P < .001 ) , and the use of RRT was 10 % ( 95 % CI , 8.1%-12 % ; n = 78 ) vs 6.3 % ( 95 % CI , 4.6%-8.1 % ; n = 49 ) ( P = .005 ) . After adjustment for covariates , this association remained for incidence of injury and failure class of RIFLE-defined AKI ( odds ratio , 0.52 [ 95 % CI , 0.37 - 0.75 ] ; P < .001 ) and use of RRT ( odds ratio , 0.52 [ 95 % CI , 0.33 - 0.81 ] ; P = .004 ) . There were no differences in hospital mortality , hospital or ICU length of stay , or need for RRT after hospital discharge . CONCLUSION The implementation of a chloride-restrictive strategy in a tertiary ICU was associated with a significant decrease in the incidence of AKI and use of RRT . TRIAL REGISTRATION Clinical trials.gov Identifier : NCT00885404 Not enough fluid and too much fluid are both bad . That is the one great irrefutable truth in fluid management in anaesthesia and in the critically ill . For almost every other question in fluid therapy there is ‘ current opinion ’ . The big questions are when , where , which and why but of greater moment than all of these is ‘ how much ’ . The current drift towards the use of smaller volumes of fluid in major surgery suggests that the right amount at the right time is probably the way to go , so volume and timing are seemingly linked . This ties in neatly with the rediscovery of the notion that early fluid resuscitation in the emergency room is better than late and dovetails with the concept that adequate resuscitation , or optimisation , improves outcome in high risk surgery . New gadgets that help to achieve this end abound since the pulmonary artery catheter fell from grace . The recent discovery of hyperchloraemic acidosis as a new iatrogenic disease entity has focused attention on the importance of the fundamental constituents of the fluids that are given [ 1 ] . The meta-analytical cloud that the Cochrane collaboration placed over albumin was dissipated by the SAFE study only to be replaced by a different evidential cloud drifting over the world of starches [ 2 ] . This has reawakened interest in the potentially malevolent nature of synthetic molecules . As the dynamics of the questions and current answers change , it is easy to become confused . The publication of the British Consensus Guidelines on Intravenous Fluid Therapy for Adult Surgical Patients could therefore not be more timely [ 3 ] . The authors have asked a very large number of relevant questions , assessed a vast array of available information and measured it with an evidence -based score to produce recommendations bundled into guidelines . There are no less than 28 evidence -scored recommendations to assist in fluid management . This major work should be m and atory reading for anyone involved in fluid management for a range of reasons that will come clear . The recommendations , all 28 of them , each has an evidence level of between 1 and 5 , although some have several evidence levels for different parts of the same question . In brief ; level 1 is very good , 1a – a systematic review or 1b a r and omised control trial , while level 4 is a
Output:
| Conclusion Balanced crystalloids and isotonic saline have no difference on various clinical outcomes including in-hospital mortality , AKI , overall ICU mortality , and new RRT . |
MS211616 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE The aim of this study was to determine the effects of Tai Chi exercise on glucose control , neuropathy scores , balance , and quality of life in patients with type 2 diabetes and neuropathy . METHODS A pretest-posttest design with a nonequivalent control group was utilized to recruit 59 diabetic patients with neuropathy from an outpatient clinic of a university hospital . A st and ardized Tai Chi for diabetes program was provided , which comprised 1 hour of Tai Chi per session , twice a week for 12 weeks . Outcome variables were fasting blood glucose and glycosylated hemoglobin for glucose control , the Semmes-Weinstein 10-g monofilament examination scores and total symptom scores for neuropathy , single leg stance for balance , and the Korean version of the SF-36v2 for quality of life . Thirty-nine patients completed the posttest measures after the 12-week Tai Chi intervention , giving a 34 % dropout rate . RESULTS The mean age of the participants was 64 years , and they had been diagnosed with type 2 diabetes for more than 12 years . The status was significantly better for the participants in the Tai Chi group ( n=20 ) than for their control ( i.e. , nonintervention ) counterparts ( n=19 ) in terms of total symptom scores , glucose control , balance , and quality of life . CONCLUSION Tai Chi improved glucose control , balance , neuropathic symptoms , and some dimensions of quality of life in diabetic patients with neuropathy . Further studies with larger sample s and long-term follow-up are needed to confirm the effects of Tai Chi on the management of diabetic neuropathy , which may have an impact on fall prevention in this population OBJECTIVE This study aim ed to vali date the effects of a simplified , gentle form of t'ai chi chuan in patients with type 2 diabetes and who are also obese . DESIGN The study was design ed to be a r and omized controlled trial . SETTING This study was conducted in the department of metabolism and endocrinology at Cheng Ching Hospital , in Taichung , Taiwan . SUBJECTS The study subjects were hospital-based patients with type 2 diabetes and who were also obese ( ages 40 - 70 , with a body-mass index [ BMI ] range of 30 - 35 ) . The patients were r and omly selected and grouped into t'ai chi exercise ( TCE ) and conventional exercise ( CE ) groups . INTERVENTIONS After receiving instruction in t'ai chi , the TCE group and the CE group practice d three times per week , including one practice session lasting up to 1 hour , for 12 weeks . OUTCOME MEASURES Hemoglobin A1C , serum lipid profile , serum malondialdehyde , and C-reactive protein were measured . Physical parameters of body weight and BMI were also measured . Diet and medications of participants were monitored carefully while biochemical and physical conditions were analyzed . RESULTS After 12 weeks , hemoglobin A1C values of the TCE group did not decrease ( 8.9 ± 2.7 % : 8.3 ± 2.2 % ; p = 0.064 ) . BMI ( 33.5 ± 4.8 : 31.3 ± 4.2 ; p = 0.038 ) and serum lipids , including triglyceride ( 214 ± 47 mg/dL : 171 ± 34 mg/dL ; p = 0.012 ) and high density lipoprotein cholesterol ( 38 ± 16 mg/dL : 45 ± 18 mg/dL ; p = 0.023 ) had significant improvements . Serum malondialdehyde tended to decrease from baseline ( 2.66 ± 0.78 μmol/L : 2.31 ± 0.55 μmol/L ; p = 0.035 ) , and C-reactive protein also decreased ( 0.39 ± 0.19 mg/dL : 0.22 ± 0.15 mg/dL ; p = 0.014 ) . No improvements occurred in BMI , lipids , and oxidative stress profiles in the CE group . CONCLUSIONS T'ai chi exercise practice d by patients who are obese and have type 2 diabetes is efficient and safe when supervised by professionals and helps improve parameters , such as BMI , lipid profile , C-reactive protein , and malondialdehyde . Periodic monitoring of blood glucose , blood pressure , heart rate , breathing , physical fitness , and symptoms of discomfort of patients who exercise helps prevent injury . Simple , gentle TCE can be applied as regular daily exercise for patients with type 2 diabetes even when such patients are obese Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more BACKGROUND a large proportion of adults with type 2 diabetes remain sedentary despite evidence of benefits from exercise for type 2 diabetes . Simplified Yang Tai Chi has been shown in one study to have no effect on insulin sensitivity in older adults . However , a modified Tai Chi form , Tai Chi for Diabetes ( TCD ) has recently been composed , cl aim ing to improve diabetes control . METHODS subjects were r and omised to Tai Chi or sham exercise , twice a week for 16 weeks . Primary outcomes were insulin resistance 72 h post-exercise ( HOMA2-IR ) , and long-term glucose control ( HbA(1c ) ) . RESULTS thirty-eight subjects ( 65 + /- 7.8 years , 79 % women ) were enrolled . Baseline BMI was 32.2 + /- 6.3 kg/m(2 ) , 84 % had osteoarthritis , 76 % hypertension , and 34 % cardiac disease . There was one dropout , no adverse events , and median compliance was 100 (0 - 100)% . There were no effects of time or group assignment on insulin resistance or HbA(1c ) ( -0.07 + /- 0.4 % Tai Chi versus 0.12 + /- 0.3 % Sham ; P = 0.13 ) at 16 weeks . Improvement in HbA(1c ) was related to decreased body fat ( r = 0.484 , P = 0.004 ) and improvement in insulin resistance was related to decreased body fat ( r = 0.37 , P = 0.03 ) and central adiposity ( r = 0.38 , P = 0.02 ) , as well as increased fat-free mass ( r = -0.46 , P = 0.005 ) . CONCLUSIONS TCD did not improve glucose homeostasis or insulin sensitivity measured 72 h after the last bout of exercise . More intense forms of Tai Chi may be required to produce the body composition changes associated with metabolic benefits in type 2 diabetes Diabetes is the leading cause of major complications , such as end-stage renal disease and lower extremity amputations , and is a significant contributor to ischemic heart disease , stroke , peripheral vascular disease , and vision loss ( 1 ) . There has been increasing acceptance of the importance of individualizing glycemic management and assessment of risk for adverse events , especially hypoglycemia ( 26 ) . This is of great importance for all patients , especially older adults ( aged 65 years ) with comorbid conditions . In 2013 , 12.0 million older adults in the United States had diabetes , comprising 40 % of the 30.2 million persons with the disease ( 7 ) . Older adults account for an estimated 60 % to 70 % of the U.S. Department of Veterans Affairs ( VA ) and U.S. Department of Defense ( DoD ) diabetic population ( largely retirees ) ( VA/DoD. Unpublished data ) . These considerations make safe and effective diabetes management a policy priority for health care providers ( physicians , nurses , dietitians , and pharmacists ) and policymakers in both the VA and the DoD. The 2017 VA/DoD Clinical Practice Guideline ( CPG ) for the Management of Type 2 Diabetes Mellitus in Primary Care offers health care providers an evidence -based framework to evaluate , treat , and manage persons with type 2 diabetes mellitus in the context of their individual needs and preferences ( 8) . The current article is a summary of key CPG recommendations , which was developed with multiple stakeholders to ensure representation by a broad spectrum of clinicians . It provides practice recommendations for the care of patients with diabetes , with an emphasis on shared decision making . Guideline Development and Review Process These recommendations were developed using methods established by the VA/DoD Evidence -Based Practice Work Group ( EBPWG ) ( 9 ) , which are aligned with st and ards for trustworthy guidelines ( 10 ) . The EBPWG and the U.S. Army Medical Comm and selected guideline panel cochairs ( 1 each from the VA and the DoD ) . The cochairs then selected a multidisciplinary panel of practicing clinician stakeholders , including primary care physicians ( family and internal medicine ) , endocrinologists , medical nutritionists , pharmacists , diabetes educators , and nurse practitioners . At the start of the CPG development process and at other key points throughout , all members were required to su bmi t disclosure statements for potential conflicts of interest in the previous 24 months . Verbal affirmations of no conflicts were used during meetings throughout the development process . The project team was also subject to r and om Web-based surveillance ( for example , ProPublica ) . The VA/DoD contracted with The Lewin Group , a third party with expertise in clinical practice guideline development , to facilitate meetings . The guideline panel , in collaboration with the ECRI Institute , developed 9 key questions using the PICOTS ( population , intervention , comparator , outcomes , timing of outcomes measurement , and setting ) format . A systematic search of the peer- review ed literature from January 2009 through March 2016 was conducted to find evidence relevant to the key questions that focused on r and omized trials , systematic review s , and meta-analyses of fair or better quality . One key question was up date d through 14 June 2016 . The search methods and results are detailed in the full guideline ( 8) . The guideline panel rated recommendations by using the GRADE ( Grading of Recommendations Assessment , Development and Evaluation ) method ( 11 ) . The guideline panel focused on developing new and up date d recommendations using the evidence review for the key questions . The panel also considered , without a complete review of the relevant evidence , the current applicability of recommendations that were included in the 2010 CPG . As part of the development process , a patient focus group was also convened to better underst and the perspectives of patients receiving diabetes treatment in the VA and the DoD. Five patients were included , consistent with the requirements of the federal Paperwork Reduction Act . All patients had type 2 diabetes and were veterans receiving care in the VA . The focus group explored knowledge of treatment options , views on the delivery of care , patients ' needs and preferences , and the effect of diabetes on their lives . Important concepts that emerged from the focus group were shared with the panel and informed guideline development . It was acknowledged that this convenience sample may not be representative of all VA and DoD patients receiving treatment for type 2 diabetes . The draft guideline was sent to more than 15 expert review ers inside and outside the federal sector . Comments were review ed and , where appropriate , were incorporated into the final guideline based on panel consensus . The VA/DoD EBPWG approved the final document on 3 April 2017 and released it on 17 April 2017 . Recommendations are presented in the Table , and an algorithm for establishing a personalized glycemic goal and treatment plan is presented in the Figure . Key recommendations are review ed in this article . Table . Summary of Recommendations From the 2017 VA/DoD CPG on the Management of Type 2 Diabetes Mellitus Figure . Algorithmic approach to evaluating glycemic control risk factors , setting a personalized glycemic control target range , providing self-management ( including lifestyle and nutrition ) education , and initiating or reevaluating medication therapy . Recommendations Provide Patient-Centered Care and Incorporate Shared Decision Making The CPG strongly encourages clinicians to incorporate shared decision making and partner with their patients . Shared decision making is the process by which the patient and family , in conjunction with the care provider , reach an agreement about a plan of care and treatment . Key principles include readiness of the patient and family , tools with underst and able information about the benefits and harms of all options , and strategies to identify and incorporate patient preferences . Patients can not effectively participate in care and shared decision making unless they underst and diabetes and how they can be involved in planning and carrying out the jointly developed care plan . Shared decision making reinforces a trusted therapeutic relationship and increases patient satisfaction and treatment buy-in with regard to the methods used to reach a particular goal or treatment plan ( 1214 ) . It should be used not only for patients with stable glycemic control but also to assist those who are not able or willing to make lifestyle changes and decisions that affect their diabetes at any time during the course of treatment . At a minimum , shared decision making should be included at the time of diagnosis , during difficulties with management , and at times of transition or development of complications ( 14 ) . Benefits include greater knowledge of medications ( 13 ) and underst and ing of risks ( 14 ) . In addition , patient-centered care and shared decision making together may decrease patient anxiety , increase trust in clinicians ( 15 ) , and improve treatment adherence ( 16 ) . Family involvement
Output:
| The observed effect was more pronounced for interventions that were medium range in duration ( i.e. , > 3-<12 months ) .
TCE interventions also showed improvements in the secondary outcome measures .
Conclusion Among patients with type 2 diabetes , TCEs were associated with significantly lower hemoglobin A1c and fasting blood glucose . |
MS211617 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: A new pneumococcal serotype 6C , earlier typed as 6A , was discovered in 2007 . We retyped all 6A isolates to evaluate vaccine efficacy against 6C acute otitis media ( AOM ) in the phase III r and omized , double-blind Finnish Otitis Media trial conducted in 1995–1999 . Efficacy against 6C AOM was −1 ( 95 % confidence interval : −248 to 71 ) during the per protocol follow-up period . The up date d vaccine efficacy estimate for serotype 6A AOM was 65 % ( 95 % confidence interval : 31–82 ) . Seven-valent pneumococcal conjugate vaccine offered excellent cross-protection against 6A AOM , but our data do not support cross-protection against 6C AOM Objective To evaluate the effects of influenza vaccination with or without heptavalent pneumococcal conjugate vaccination on respiratory tract infections ( RTIs ) in children . Study design This was a r and omized , double-blind , placebo-controlled trial comprising 579 children age 18 to 72 months with a previous history of physician-diagnosed RTI , recruited between 2003 and 2005 . The children were assigned to 2 doses of parenteral inactivated trivalent subunit influenza plus heptavalent pneumococcal conjugate vaccination ( TIV+PCV7 ) , influenza plus placebo vaccination ( TIV+plac ) , or control hepatitis B virus vaccination plus placebo ( HBV+plac ) . Main outcome measures were febrile RTI and related polymerase chain reaction (PCR)-confirmed influenza , primary care visits , antibiotic prescriptions , and acute otitis media ( AOM ) episodes . Results During influenza seasons , febrile RTI were reduced by 24 % ( 95 % confidence interval [ CI ] = 1 % to 42 % ) in the TIV+PCV7 group and by 13 % ( 95 % CI = -12 % to 32 % ) in the TIV+plac group compared with the control group . The occurrence of PCR-confirmed influenza was reduced by 52 % ( 95 % CI = 7 % to 75 % ) in the TIV+PCV7 group and by 51 % ( 95 % CI = 3 % to 75 % ) in the TIV+plac group . Episodes of AOM were reduced by 57 % ( 95 % CI = 6 % to 80 % ) in the TIV+PCV7 group and by 71 % ( 95 % CI = 30 % to 88 % ) in the TIV+plac group . Outside of the influenza seasons , no significant effects of vaccinations were demonstrated on the studied outcomes . Conclusions During influenza seasons , influenza vaccination with or without pneumococcal conjugate vaccination substantially reduced cases of confirmed influenza and AOM episodes ABSTRACT We previously reported 10-valent pneumococcal non-typeable Haemophilus influenzae ( NTHi ) protein D conjugate vaccine ( PHiD-CV ) efficacy in a double-blind r and omized trial ( Clinical Trials.gov : NCT00466947 ) against various diseases , including acute otitis media ( AOM ) . Here , we provide further analyses . In the Panamanian subset , 7,359 children were r and omized ( 1:1 ) to receive PHiD-CV or control vaccine at age 2/4/6 and 15–18 months . Of these , 2,000 had nasopharyngeal swabs collected . AOM cases were captured when parents sought medical attention for children with AOM symptoms ; surveillance was enhanced approximately 2 y into the study through regular telephone calls or home visits by study personnel , who advised parents to visit the clinic if their child had AOM symptoms . Mean follow-up was 31.4 months . Clinical AOM ( C-AOM ) cases were assessed by physicians and confirmed by otorhinolaryngologists . Middle ear fluid sample s , taken from children with C-AOM after specific informed consent , and nasopharyngeal sample s were cultured for pathogen identification . For 7,359 children , 2,574 suspected AOM cases were assessed by a primary healthcare physician ; 649 cases were C-AOM cases as per protocol definition . From the 503 MEF sample s collected , 158 result ed in a positive culture . In the intent-to-treat cohort ( 7,214 children ) , PHiD-CV showed VE against first C-AOM ( 24.0 % [ 95 % CI : 8.7 , 36.7 ] ) and bacterial ( B-AOM ) episodes ( 48.0 % [ 20.3 , 66.1 ] ) in children < 24 months , which declined thereafter with age . Pre-booster VE against C-AOM was 30.7 % [ 12.9 , 44.9 ] ; post-booster , −6.7 % [ −36.4 , 16.6 ] . PHiD-CV VE was 17.7 % [ −6.1 , 36.2 ] against moderate and 32.7 % [ −20.5 , 62.4 ] against severe C-AOM . VE against vaccine-serotype pneumococcal NPC was 31.2 % [ 5.3 , 50.3 ] 3 months post-booster , and 25.6 % [ 12.7 , 36.7 ] across all visits . NTHi colonization rates were low and no significant reduction was observed . PHiD-CV showed efficacy against C-AOM and B-AOM in children younger than 24 months , and reduced vaccine-serotype NPC Estimation of the full disease burden caused by Streptococcus pneumoniae is challenging due to the difficulties in assigning the aetiology especially in lower and upper respiratory infections . We estimated the pneumococcal disease burden by using the vaccine-preventable disease incidence ( VPDI ) of PHiD-CV10 vaccine ( GSK ) in our clinical trial setting . Finnish Invasive Pneumococcal disease ( FinIP ) trial was a cluster-r and omized , double-blind trial in children < 19 months who received PHiD-CV10 in 52 clusters or hepatitis B/A vaccine as control in 26 clusters according to 3 + 1 or 2 + 1 schedules ( infants < 7 months ) or catch-up schedules ( children 7 - 18 months ) . Outcome data were collected using Finnish routine health-care registers , consisting of THL National Infectious Diseases Register , THL Care register , and Benefits Register of Social Insurance Institution of Finl and . Blinded follow-up lasted from the date of first vaccination ( trial enrolment Feb-2009 through Aug-2010 ) to January 31 , 2012 for Invasive Pneumococcal Disease ( IPD ) and to end of December 2011 for four other outcomes : non-laboratory-confirmed IPD , hospital-diagnosed pneumonia , tympanostomy tube placements , and antimicrobial purchases . VPDI was estimated as difference in disease incidences between PHiD-CV10 clusters and control clusters . Altogether > 47,000 children were enrolled . In 30,527 vaccinated infants < 7 months at first dose , the VPDIs per 100,000 person-years were 75 for laboratory-confirmed IPD , 210 for non-laboratory-confirmed IPD , 271 for hospital-diagnosed pneumonia , 1143 for any tympanostomy tube placements and 11,381 for antimicrobial outpatient prescription , mainly due to otitis media . In a European developed-country setting , over 95 % of the disease episode reductions in vaccinated children were seen in mild upper respiratory infections . The VPDIs of severe diseases are underestimated , because the majority of invasive disease goes undetected with routine blood-culture-based definitions . Evaluation of the absolute reduction achievable with vaccinations using sensitive case detection is essential for underst and ing the full disease burden , for valid cost-effectiveness analyses and for appropriate vaccination policy decisions . Registration : Clinical Trials.gov , NCT00861380 and NCT00839254 After administering the 10-valent pneumococcal polysaccharide nontypeable Haemophilus influenzae protein D – conjugated vaccine ( PHiD-CV ) to children aged 2–18 months , we observed a reduction in vaccine-type nasopharyngeal carriage , result ing in a reduction of overall pneumococcal nasopharyngeal carriage , which may be important for indirect vaccine effects . We noted a trend toward reduction of acute otitis media . Background This trial ( Clinical Trials.gov identifier NCT00839254 ) , nested within a cluster-r and omized double-blind invasive pneumococcal disease effectiveness study in Finl and ( Clinical Trials.gov identifier NCT00861380 ) , assessed the effectiveness of the 10-valent pneumococcal polysaccharide nontypeable Haemophilus influenzae protein D – conjugated vaccine ( PHiD-CV or PCV10 ) against bacterial nasopharyngeal carriage and acute otitis media ( AOM ) . Methods Infants ( aged 6 weeks to 6 months ) received the PHiD-CV or a control vaccine ( hepatitis B ) ( schedule 3 + 1 or 2 + 1 ) . Nasopharyngeal swabs were collected at 4 time points post-vaccination from all of the infants and at pre-vaccination from a subset . Parent-reported physician-diagnosed AOM was assessed from first vaccination until last contact ( mean follow-up , 18 months ) . Vaccine effectiveness ( VE ) was derived as ( 1 – relative risk)*100 , accounting for cluster design in AOM analysis . Significant VE was assessed descriptively ( positive lower limit of the non-adjusted 95 % confidence interval [ CI ] ) . Results The vaccinated cohort included 5093 infants for carriage assessment and 4117 infants for AOM assessment . Both schedules decreased vaccine-serotype carriage , with a trend toward a lesser effect from the 2 + 1 schedule ( VE across timpoints 19%–56 % [ 3 + 1 ] and 1%–38 % [ 2 + 1 ] ) . Trends toward reduced pneumococcal carriage ( predominantly vaccine serotypes 6B , 14 , 19F , and 23F ) , decreased carriage of vaccine-related serotype 19A , and small increases at later time points ( ages 14–15 months ) in non – vaccine-serotype carriage were observed . No effects on nontypeable Haemophilus influenzae , Staphylococcus aureus , or Moraxella catarrhalis carriage were observed . There were non-significant trends toward a reduction in the number of infants reporting AOM episodes ( VE 3 + 1 : 6.1 % [ 95 % CI , −2.7 % to 14.1 % ] and 2 + 1 : 7.4 % [ −2.8 % to 16.6 % ] ) and all AOM episodes ( VE 3 + 1 : 2.8 % [ −9.5 % to 13.9 % ] and 2 + 1 : 10.2 % [ −4.1 % to 22.9 % ] ) . PHiD-CV was immunogenic and had an acceptable safety profile . Conclusions We observed reduced vaccine-type pneumococcal carriage , a limited increase in non – vaccine-type carriage , and a trend toward AOM reduction In a double-blind r and omized controlled trial , Xavier Saez-Llorens and colleagues examine the vaccine efficacy of PHiD-CV against community-acquired pneumonia in young children in Panama , Argentina , and Columbia . Please see later in the article for the Editors ' BACKGROUND Pneumococcal conjugate vaccine prevents recurrent acute otitis media ( AOM ) in infants immunised at 2 , 4 , 6 , and 12 - 15 months of age . We aim ed to find out whether this vaccine also prevents AOM in older children who have had previous episodes of AOM . METHODS In this double-blind , r and omised study , we enrolled 383 patients aged 1 - 7 years who had had two or more episodes of AOM in the year before entry . R and omisation was stratified in four groups according to age ( 12 - 24 months vs 25 - 84 months ) and the number of previous AOM episodes ( two or three episodes vs four or more episodes ) . Children received either 7-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine , or hepatitis A or B vaccines . They were followed up for 18 months for recurrence of AOM . We also cultured sample s of middle-ear fluid and nasopharyngeal swabs to assess association of pneumococcal serotypes with AOM after vaccination . FINDINGS We noted no reduction of AOM episodes in the pneumococcal vaccine group compared with controls ( intention-to-treat analysis : rate ratio 1.25 , 95 % CI 0.99 - 1.57 ) . Although nasopharyngeal carriage of pneumococci of serotypes included in the conjugate-v
Output:
| Administration of the licenced CRM197-PCV7 and PHiD-CV10 during early infancy is associated with large relative risk reductions in pneumococcal AOM .
However , the effects of these vaccines on all-cause AOM is far more uncertain .
We found no evidence of a beneficial effect on all-cause AOM of administering PCVs in high-risk infants , after early infancy ( i.e. in children one year and above ) , and in older children with a history of respiratory illness .
Compared to control vaccines , PCVs were associated with an increase in mild local reactions ( redness , swelling ) , fever , and pain and /or tenderness .
We found no evidence of a difference in more severe local reactions , fever , or serious adverse events judged causally related to vaccination |
MS211618 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE To identify predictors of success for physiotherapy treatment in women with persistent postpartum stress urinary incontinence ( SUI ) . DESIGN Secondary analysis of data from a single-blind r and omized controlled trial comparing 2 physiotherapy intervention programs for persistent SUI in postpartum women . SETTING Obstetric clinic of a mother and children 's university hospital . PARTICIPANTS Women , ages 23 to 39 ( N=57 ) , were r and omized to 1 of 2 pelvic floor muscle ( PFM ) training programs , 1 with and 1 without abdominal muscle training . INTERVENTION Over 8 weeks , participants in each group followed a specific home exercise program once a day , 5 days a week . In addition , participants attended individual weekly physiotherapy sessions throughout the 8-week program . MAIN OUTCOME MEASURES Treatment success was defined as a pad weight gain of less than 2 g on a 20-minute pad test with st and ardized bladder volume after 8 weeks ' treatment . The relationship between potential predictive PFM function variables as measured by a PFM dynamometer and success of physiotherapy was studied using forward stepwise multivariate logistic regression analyses . RESULTS Forty-two women ( 74 % ) were classified as treatment successes , and 15 ( 26 % ) were not . Treatment success was associated with lower pretreatment PFM passive force and greater PFM endurance pretreatment , but the latter association was barely statistically significant . This model explained between 23 % ( Cox and Snell R(2 ) ) and 34 % ( Nagelkerke R(2 ) ) of the outcome variability . CONCLUSIONS The results contribute new information on predictors of success for physiotherapy treatment in women with persistent postpartum SUI Objective To assess the effect of pelvic floor education after vaginal delivery on pelvic floor characteristics in nulliparous women . Methods We examined 107 nulliparas during pregnancy and at 9 weeks and 10 months after vaginal delivery . Methods used included a question naire , clinical examination , perineosonography , urethral pressure profiles , and intravaginal and intra-anal pressure recordings during pelvic floor contraction . After the second examination , the women were assigned in alternating manner to either 12 sessions of pelvic floor exercises with biofeedback and electrostimulation ( n = 51 ) or no training ( n = 56 ) . The two groups were compared at the third examination . Results Stress urinary incontinence incidence decreased in 2 % of control subjects compared with 19 % of women who underwent pelvic floor education ( P = .002 ) , whereas the incidence of fecal incontinence ( 5 % versus 4 % , P = 1 ) and the percentage of women who recovered predelivery pelvic floor contraction strength ( 33 % versus 41 % , P = .4 ) were no different . We observed no significant differences in bladder neck position and mobility , urethral functional length , maximal urethral closure pressure , pressure transmission ratio , residual area of continence at stress st and ing , or intravaginal or intra-anal pressures during pelvic floor contraction between groups at the third examination . Conclusion Pelvic floor education , begun 2 months postpartum , significantly reduced the incidence of stress urinary incontinence , but not fecal incontinence or weak pelvic floor . Similarly , bladder neck behavior , urodynamic characteristics , intravaginal or intra-anal pressures during pelvic floor squeezing also were not modified Background Both maternal pre-pregnancy obesity and excessive gestational weight gain are increasing in prevalence and associated with a number of adverse pregnancy outcomes for both mother and child . Observational studies regarding physical activity in pregnancy have found reduced weight gain in active mothers , as well as reduced risk of adverse pregnancy outcomes . There is however a lack of high quality , r and omized controlled trials on the effects of regular exercise training in pregnancy , especially those with a pre-pregnancy body mass index ( BMI ) at or above 30 kg/m2 . Methods We are conducting a r and omised , controlled trial in Norway with two parallel arms ; one intervention group and one control group . We will enroll 150 previously sedentary , pregnant women with a pre-pregnancy BMI at or above 30 kg/m2 . The intervention group will meet for organized exercise training three times per week , starting in gestation week 14 ( range 12 - 16 ) . The control group will get st and ard antenatal care . The main outcome measure will be weight gain from baseline to delivery . Among the secondary outcome measures are changes in exercise capacity , endothelial function , physical activity level , body composition , serum markers of cardiovascular risk , incontinence , lumbopelvic pain and cardiac function from baseline to gestation week 37 ( range 36 - 38 ) . Offspring outcome measures include anthropometric variables at birth , Apgar score , as well as serum markers of inflammation and metabolism in cord blood . Discussion The results of this trial will provide knowledge about effects of regular exercise training in previously sedentary , obese pregnant women . If the program proves effective in reducing gestational weight gain and adverse pregnancy outcomes , such programs should be considered as part of routine pregnancy care for obese women . Trial Registration Clinical Trials.gov : A physiotherapist-delivered continence promotion program was recently implemented with postpartum women in Australia . A previous r and omised controlled trial demonstrated that the program was effective in promoting pelvic floor exercises and continence at 3 months postpartum . The present study compares pelvic floor exercise frequency and continence status for women in the intervention and ‘ usual care ’ control groups at 12 months postpartum . While there was no significant difference in continence status , women in the intervention group were more likely than those in the control group to be practising pelvic floor exercises at adequate frequencies . In turn , continued adherence to pelvic floor exercises at 12 months was predictive of continence at that time . Potential strategies for enhancing women ’s adherence to pelvic floor exercise regimes during and beyond the postpartum year are discussed OBJECTIVE : The long-term prevalence of anal incontinence after vaginal delivery is unknown . The aim of the present study was to evaluate the prevalence of anal incontinence in primiparous women 5 years after their first delivery and to evaluate the influence of subsequent childbirth . METHODS : A total of 349 nulliparous women were prospect ively followed up with question naires before pregnancy , at 5 and 9 months , and 5 years after delivery . A total of 242 women completed all question naires . Women with sphincter tear at their first delivery were compared with women without such injury . Risk factors for development of anal incontinence were also analyzed . RESULTS : Anal incontinence increased significantly during the study period . Among women with sphincter tears , 44 % reported anal incontinence at 9 months and 53 % at 5 years ( P = .002 ) . Twenty-five percent of women without a sphincter tear reported anal incontinence at 9 months and 32 % had symptoms at 5 years ( P < .001 ) . Risk factors for anal incontinence at 5 years were age ( odds ratio [ OR ] 1.1 ; 95 % confidence interval [ CI ] 1.0–1.2 ) , sphincter tear ( OR 2.3 ; 95 % CI 1.1–5.0 ) , and subsequent childbirth ( OR 2.4 ; 95 % CI 1.1–5.6 ) . As a predictor of anal incontinence at 5 years after the first delivery , anal incontinence at both 5 months ( OR 3.8 ; 95 % CI 2.0–7.3 ) and 9 months ( OR 4.3 ; 95 % CI 2.2–8.2 ) was identified . Among women with symptoms , the majority had infrequent incontinence to flatus , whereas fecal incontinence was rare . CONCLUSION : Anal incontinence among primiparous women increases over time and is affected by further childbirth . Anal incontinence at 9 months postpartum is an important predictor of persisting symptoms Introduction and hypothesisThe objective was to examine the relationship between maternal and perinatal factors and the occurrence of stress ( SUI ) or mixed ( MUI ) urinary incontinence ( UI ) 1 year after the first vaginal delivery in primiparous women . Methods Participants in this prospect i ve cohort were recruited consecutively from June 2003 to July 2005 from all eligible women who delivered in the department . A vali date d question naire , the International Consultation of Incontinence Question naire Short Form ( ICIQ-SF ) was completed by all participants 2–3 days after delivery , and a similar second question naire was filled out 1 year later . Additional data were obtained from the medical records . The first question naire was completed by 1,018 women ( 63 % ) and the second by 859 women ( 84 % ) . The study group comprised the 575 women without any UI before the pregnancy and who had a vaginal delivery . The primary analysis comprised 117 women with either SUI or MUI 1 year after the vaginal delivery and 403 women without any UI . Results In univariate analyses , the following factors were associated with SUI or MUI : prepregnancy body mass index ( BMI ) ≥ 30 ( p < 0.05 ) , UI during the pregnancy ( p < 0.05 ) , perineal lesions ( p < 0.05 ) , and anal sphincter tears ( p = 0.05 ) . Logistic regression analysis showed that SUI or MUI was strongly associated with UI during the pregnancy [ adjusted odds ratio ( OR ) 4.7 , 95 % confidence interval ( CI ) 2.9–7.7 ) and inversely associated with oxytocin augmentation ( adjusted OR 0.5 , 95 % CI 0.3–0.9 ) . Conclusions SUI or MUI 1 year after the first vaginal delivery was strongly associated with UI during the pregnancy and inversely associated with oxytocin augmentation OBJECTIVE The purpose of this study was to determine the effects of extracorporeal magnetic innervation ( ExMI ) on pelvic muscle strength of primiparous patients . STUDY DESIGN Primigravid patients were r and omized to receive either active or sham ExMI postpartum treatments for 8 weeks . The main outcome measure was pelvic muscle strength measured by perineometry at baseline ( midtrimester ) , 6 weeks ( before treatments ) , 14 weeks , 6 months , and 12 months postpartum . Mixed r and omized-repeated measures ANOVA was used to analyze the mean perineometry values between the 2 groups and across all 5 time periods . RESULTS Fifty-one patients enrolled , and 18 were lost to attrition . There were no differences in demographics or delivery characteristics between the active and sham groups . There was an overall time effect , F(3,85 ) = 3.1 , P = .049 , but no group , F(1,31 ) = 0.007 , P = .94 , or (group)(time ) interaction , F(3,85 ) = 1.8 , P = .15 . CONCLUSION We found no differences in pelvic muscle strength between patients receiving active or sham ExMI treatments in the early postpartum period Objective : To investigate the effect of supervised and unsupervised pelvic floor muscle exercises utilizing trunk stabilization for treating postpartum urinary incontinence and to compare the outcomes . Design : R and omized , single-blind controlled study . Setting : Outpatient rehabilitation hospital . Subjects : Eighteen subjects with postpartum urinary incontinence . Interventions : Subjects were r and omized to either a supervised training group with verbal instruction from a physiotherapist , or an unsupervised training group after undergoing a supervised demonstration session . Main measures : Bristol Female Lower Urinary Tract Symptom question naire ( urinary symptoms and quality of life ) and vaginal function test ( maximal vaginal squeeze pressure and holding time ) using a perineometer . Results : The change values for urinary symptoms ( −27.22 ± 6.20 versus −18.22 ± 5.49 ) , quality of life ( −5.33 ± 2.96 versus −1.78 ± 3.93 ) , total score ( −32.56 ± 8.17 versus −20.00 ± 6.67 ) , maximal vaginal squeeze pressure ( 18.96 ± 9.08 versus 2.67 ± 3.64 mmHg ) , and holding time ( 11.32 ± 3.17 versus 5.72 ± 2.29 seconds ) were more improved in the supervised group than in the unsupervised group ( P < 0.05 ) . In the supervised group , significant differences were found for all variables between pre- and post-test values ( P < 0.01 ) , whereas the unsupervised group showed significant differences for urinary symptom score , total score and holding time between the pre- and post-test results ( P < 0.05 ) . Conclusions : These findings suggest that exercising the pelvic floor muscles by utilizing trunk stabilization under physiotherapist supervision may be beneficial for the management of postpartum urinary incontinence A r and omized controlled trial was carried out to evaluate the extent to which a program of reinforced pelvic floor muscle exercises ( PFME ) reduces urinary incontinence 1 year after delivery . Two hundred and thirty women who were incontinent 3 months postpartum were r and omized to either a control group doing st and ard postnatal pelvic floor muscle exercises ( n=117 ) or to an intervention group ( n=113 ) who saw a physiother
Output:
| It seemed that the more intensive the programme the greater the treatment effect .
It is possible that mixed prevention and treatment approaches might be effective when the intervention is intensive enough .
There was little evidence about long-term effects for either urinary or faecal incontinence .
AUTHORS ' CONCLUSIONS There is some evidence that for women having their first baby , PFMT can prevent urinary incontinence up to six months after delivery .
There is support for the widespread recommendation that PFMT is an appropriate treatment for women with persistent postpartum urinary incontinence . |
MS211619 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Objective To compare patient satisfaction , discomfort , procedure time , success rate and adverse events of hysteroscopic ( ESSURE , Conceptus Inc , San Carlos , USA ) versus laparoscopic sterilisation OBJECTIVE To assess the safety , effectiveness , and reliability of a tubal occlusion microinsert for permanent contraception , as well as to document patient recovery from the placement procedure and overall patient satisfaction . METHODS A cohort of 518 previously fertile women seeking sterilization participated in this prospect i ve , phase III , international , multicenter trial . Microinsert placement was attempted in 507 women . Microinserts were placed bilaterally into the proximal fallopian tube lumens under hysteroscopic visualization in outpatient procedures . RESULTS Bilateral placement of the microinsert was achieved in 464 ( 92 % ) of 507 women . The most common reasons for failure to achieve satisfactory placement were tubal obstruction and stenosis or difficult access to the proximal tubal lumen . More than half of the women rated the average pain during the procedure as either mild or none , and 88 % rated tolerance of device placement procedure as good to excellent . Average time to discharge was 80 minutes . Sixty percent of women returned to normal function within 1 day or less , and 92 % missed 1 day or less of work . Three months after placement , correct microinsert placement and tubal occlusion were confirmed in 96 % and 92 % of cases , respectively . Comfort was rated as good to excellent by 99 % of women at all follow-up visits . Ultimately , 449 of 518 women ( 87 % ) could rely on the microinsert for permanent contraception . After 9620 woman-months of exposure to intercourse , no pregnancies have been recorded . CONCLUSION This study demonstrates that hysteroscopic interval tubal sterilization with microinserts is well tolerated and results in rapid recovery , high patient satisfaction , and effective permanent contraception OBJECTIVE To evaluate women 's satisfaction and tolerance of hysteroscopic sterilization . DESIGN Prospect i ve analysis of case series . SETTING Gynecology department in a teaching hospital . PATIENT(S ) A total of 1,630 women who underwent hysteroscopic sterilization by placement of Essure microinserts ( Conceptus , Inc. , Mountain View , CA ) from January 2003 to June 2006 . INTERVENTION(S ) Transvaginal ultrasound examination , pelvic x-ray examination , and hysterosalpingography 3 months after sterilization with Essure microinserts . Satisfaction was assessed by a visual analog scale . Adverse effects and tolerance also were recorded . MAIN OUTCOME MEASURE(S ) Transvaginal ultrasound and pelvic x-ray confirmation of correct localization of microinserts and patient 's satisfaction and tolerance after a 3-month follow-up . RESULT ( S ) The rate of successful insertion was 99 % . Most of women returned to their daily activities on the same day of insertion , and 86.5 % considered the procedure painless or scarcely painful . All the patients were highly satisfied after hysteroscopic sterilization : 91 % of subjects by visual analog scale ( on a 0 to 10 scale ) rated the method at 10 ( high satisfaction degree ) , and none of the subjects rated it under 8 . For patients , the most valuable aspects of the procedure were absence of surgery room ( 52.7 % ) , method 's quickness and comfort ( 19.9 % ) , and permanent sterilization ( 18.2 % ) . More than 97 % of the patients said that they would recommend the procedure to others . CONCLUSION ( S ) This study provides evidence that Essure microinserts can be placed in a usual gynecologic consultation room in st and ard conditions without any type of anesthesia or sedation and are associated with great overall patient satisfaction . Women also have high tolerance for the procedure and describe minor postoperative pain STUDY OBJECTIVE To compare hysteroscopic female sterilization procedures performed in-office versus a hospital operating room ( OR ) among newly trained physicians . DESIGN Multisite hospital operating rooms and physician offices . PATIENTS Women desiring permanent hysteroscopic sterilization . INTERVENTION Hysteroscopic female sterilization with the Essure system . MEASUREMENTS AND MAIN RESULTS Procedure time ( scope in/scope out time ) , device placement rates , and incidence of complications and adverse events were compared . There was no significant difference in scope time between the 2 setting s. There was no significant difference in placement rates , although the placement rate was somewhat higher in-office ( 91 % vs 88 % ) . There were no complications among any of the procedures , and the incidence of minor adverse events was extremely low in both setting s ( OR=2 % , in-office=1 % ) . CONCLUSION There is no clear advantage to performing hysteroscopic sterilization in a hospital OR . Hysteroscopic sterilization can be performed safely and efficiently in an office setting OBJECTIVE : To estimate the efficacy of paracervical block compared with saline for pain relief during office hysteroscopic sterilization . METHODS : This study was a r and omized , placebo-controlled study of women desiring hysteroscopic sterilization . A paracervical block of 1 % lidocaine or normal saline was administered before office hysteroscopic sterilization . Patients and investigators were blinded to assignments . A pre hoc power analysis determined that 40 women would be required per arm to detect a difference of 0.9 cm on a visual analog scale . Pain was recorded on a visual analog scale at multiple procedure time points . Individualized st and ardized pain scores were constructed by weighted reporting of objective and subjective sensation . RESULTS : A total of 103 consecutive women were eligible , and 80 women were r and omized , with 40 per group . Thirty-seven ( 93 % ) in each group had successful placement . The lidocaine group showed significantly lower pain scores for tenaculum placement ( mean±st and ard deviation : 0.97±1.28 compared with 3.00±2.41 , P<.001 ) traversing the external cervical os ( 1.46±1.71 compared with 3.77±2.68 , P<.001 ) and internal os ( 1.79±2.11 compared with 4.10±2.77 , P<.001 ) . There was no significant observed difference with device placement in tubal ostium ( 3.15±2.69 compared with 3.74±2.73 , P=.33 ) . Multivariable linear regression analysis demonstrated a relationship of pain to procedural time ( P=.047 ) and to group assignment ( P<.01 ) . CONCLUSION : Paracervical block with 1 % lidocaine provides effective pain relief for cervical manipulations during office hysteroscopic sterilization , but does not reduce the pain associated with upper uterine/tubal manipulation when placing the devices . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00811187 . LEVEL OF EVIDENCE : OBJECTIVE To evaluate the results of hysteroscopic placement of an intratubal device for permanent birth control in 85 women in an outpatient setting . DESIGN Prospect i ve , observational study . SETTING Private university hospital . PATIENT(S ) Eighty-five premenopausal women who asked for tubal sterilization by hysteroscopy between July 2002 and July 2003 . INTERVENTION(S ) Hysteroscopic placement of titanium-dacron intratubal devices in an outpatient setting . MAIN OUTCOME MEASURE(S ) Procedure feasibility without anesthesia , success rate of device implantation , patient satisfaction , and confirmation of correct placement . RESULT ( S ) Successful placement was achieved in 81 patients ( 95 % ) . Mean time elapsed between the start of hysteroscopy , placement of devices , and removal of optics was 9 minutes ( range , 1 - 35 minutes ) . No intraoperative or postoperative complications were detected . Of 81 patients , 75 ( 93 % ) had abdominal x-ray performed at the third month ; bilateral correct placement was confirmed in all of them . CONCLUSION ( S ) Essure is a safe , effective , and minimally aggressive procedure with satisfactory patient acceptance that does not require anesthesia or hospitalization . It seems to be a good alternative to laparoscopic tubal sterilization Objective To estimate the risk of intraoperative or postoperative complications for interval laparoscopic tubal sterilizations . Methods We used a prospect i ve , multicenter cohort study of 9475 women who had interval laparoscopic tubal sterilization to calculate the rates of intraoperative or postoperative complications . The relative safety of various methods was assessed by calculating overall complication rates for each major method of tubal occlusion . Method -related complication rates also were calculated and included only complications attributable to a method of occlusion . We used logistic regression to identify independent predictors of one or more complications . Results When we used a more restrictive definition of unintended major surgery , the overall rate of complications went from 1.6 to 0.9 per 100 procedures . There was one life-threatening event and there were no deaths . Complications rates for each of the four major methods of tubal occlusion ranged from 1.17 to 1.95 , with no significant differences between them . When complication rates were calculated , the spring clip method had the lowest method -related complication rate ( 0.47 per 100 procedures ) , although it was not significantly different from the others . In adjusted analysis , diabetes mellitus ( adjusted odds ratio [ OR ] 4.5 ; 95 % confidence interval [ CI ] 2.3 , 8.8 ) , general anesthesia ( OR 3.2 ; CI 1.6 , 6.6 ) , previous abdominal or pelvic surgery ( OR 2.0 ; CI 1.4 , 2.9 ) , and obesity ( OR 1.7 ; CI 1.2 , 2.6 ) were independent predictors of one or more complications . Conclusion Interval laparoscopic sterilization generally is a safe procedure ; serious morbidity is rare STUDY OBJECTIVE To compare the pain reported by patients during the Essure Micro-Insert sterilization procedure using either intravenous conscious sedation or oral analgesia . DESIGN R and omized , double-blind , placebo-controlled trial ( Canadian Task Force classification I ) . SETTING Tertiary care ambulatory women 's clinic . PATIENTS Eighty women of reproductive age women requesting permanent sterilization . INTERVENTION Hysteroscopic placement of the Essure Micro-Insert permanent birth control system . MEASUREMENTS AND MAIN RESULTS Patients undergoing placement of the Essure Micro-Insert system for permanent contraception were r and omized to receive either intravenous conscious sedation , oral analgesia , or placebo . During the procedure , pain scores were recorded using a visual analog scale . Patients in the oral analgesia group reported slightly more pain during insertion of the hysteroscope and placement of the second micro-insert ; the groups were otherwise equivalent . They were also equivalent when all visual analog scale scores were combined . CONCLUSION Oral analgesia is an effective method of pain control during placement of the Essure Micro-Insert permanent birth control system OBJECTIVE To assess pain and patient satisfaction with office-based hysteroscopic sterilization . DESIGN This prospect i ve , observational study was design ed to assess patient pain perception and satisfaction with office-based hysteroscopic sterilization using the Essure device ( Conceptus , Mountain View , CA ) . SETTING Faculty practice office at an inner-city urban medical center . PATIENT(S ) Women seeking hysteroscopic sterilization . INTERVENTION(S ) Office hysteroscopic sterilization under local anesthesia . MAIN OUTCOME MEASURE(S ) Pain assessed at the time of the procedure by a 0 - 10 visual scale and satisfaction by a 1 - 5 scale . RESULT ( S ) From June 2003 to June 2006 , 209 patients were recruited . The mean scores for average procedural pain , most procedural pain , and average menstrual pain were 2.6+/-2.1 , 3.3+/-2.5 , and 3.6+/-2.6 , respectively . St and ardized pain scores revealed that 149 subjects ( 70 % ) experienced average pain that was less than or equal to the pain experienced with their menses . Mean satisfaction rating for the procedure was 4.7+/-0.71 . CONCLUSION ( S ) Office-based hysteroscopic sterilization performed with local anesthesia alone is well tolerated , and patients are satisfied with this method for permanent sterilization Objective To compare becteriostatic saline and buffered lidocaine for cervical anesthesia to blunt the reported pain during brief suction curettage . Methods A double-blind r and omized clinical trial was conducted on women presenting for pregnancy termination procedures . Participants received either paracervical submucosal injections of bacteriostatic saline or 1 % buffered lidocaine just before cervical dilation . Self-reported pain intensity was assessed at three time points during and 30 minutes after the procedure . Results Fifty-two of 135 eligible women presenting for pregnancy termination procedures participated in the study . Pain intensity ratings in lidocaine and saline treatment subjects did not differ significantly at any point . Our study had a power of .094 to detect more than a 15 % difference on the 21-point box scale between the two solutions . Only one patient requested her block be repeated , and she had received lidocaine originally . Furthermore , of those women receiving lidocaine , 11
Output:
| The available literature is insufficient to determine the appropriate analgesia or anesthesia for sterilization by hysteroscopy .
Compared to paracervical block with normal saline , paracervical block with lidocaine reduced pain during some portions of the procedure .
Intravenous sedation result ed in lower pain scores during insertion of the second tubal device .
However , neither paracervical block with lidocaine nor conscious sedation significantly reduced overall pain scores for sterilization by hysteroscopy |
MS211620 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective : The phase III GO-FORWARD study examined the efficacy and safety of golimumab in patients with active rheumatoid arthritis ( RA ) despite methotrexate therapy . Methods : Patients were r and omly assigned in a 3 : 3 : 2 : 2 ratio to receive placebo injections plus methotrexate capsules ( group 1 , n = 133 ) , golimumab 100 mg injections plus placebo capsules ( group 2 , n = 133 ) , golimumab 50 mg injections plus methotrexate capsules ( group 3 , n = 89 ) , or golimumab 100 mg injections plus methotrexate capsules ( group 4 , n = 89 ) . Injections were administered subcutaneously every 4 weeks . The co- primary endpoints were the proportion of patients with 20 % or greater improvement in the American College of Rheumatology criteria ( ACR20 ) at week 14 and the change from baseline in the health assessment question naire-disability index ( HAQ-DI ) score at week 24 . Results : The proportion of patients who achieved an ACR20 response at week 14 was 33.1 % in the placebo plus methotrexate group , 44.4 % ( p = 0.059 ) in the golimumab 100 mg plus placebo group , 55.1 % ( p = 0.001 ) in the golimumab 50 mg plus methotrexate group and 56.2 % ( p<0.001 ) in the golimumab 100 mg plus methotrexate group . At week 24 , median improvements from baseline in HAQ-DI scores were 0.13 , 0.13 ( p = 0.240 ) , 0.38 ( p<0.001 ) and 0.50 ( p<0.001 ) , respectively . During the placebo-controlled portion of the study ( to week 16 ) , serious adverse events occurred in 2.3 % , 3.8 % , 5.6 % and 9.0 % of patients and serious infections occurred in 0.8 % , 0.8 % , 2.2 % and 5.6 % , respectively . Conclusion : The addition of golimumab to methotrexate in patients with active RA despite methotrexate therapy significantly reduced the signs and symptoms of RA and improved physical function Objective Interleukin (IL)-12 and IL-23 have been implicated in the pathogenesis of rheumatoid arthritis ( RA ) . The safety and efficacy of ustekinumab , a human monoclonal anti-IL-12/23 p40 antibody , and guselkumab , a human monoclonal anti-IL-23 antibody , were evaluated in adults with active RA despite methotrexate ( MTX ) therapy . Methods Patients were r and omly assigned ( 1:1:1:1:1 ) to receive placebo at weeks 0 , 4 and every 8 weeks ( n=55 ) , ustekinumab 90 mg at weeks 0 , 4 and every 8 weeks ( n=55 ) , ustekinumab 90 mg at weeks 0 , 4 and every 12 weeks ( n=55 ) , guselkumab 50 mg at weeks 0 , 4 and every 8 weeks ( n=55 ) , or guselkumab 200 mg at weeks 0 , 4 and every 8 weeks ( n=54 ) through week 28 ; all patients continued a stable dose of MTX ( 10–25 mg/week ) . The primary end point was the proportion of patients with at least a 20 % improvement in the American College of Rheumatology criteria ( ACR 20 ) at week 28 . Safety was monitored through week 48 . Results At week 28 , there were no statistically significant differences in the proportions of patients achieving an ACR 20 response between the combined ustekinumab group ( 53.6 % ) or the combined guselkumab group ( 41.3 % ) compared with placebo ( 40.0 % ) ( p=0.101 and p=0.877 , respectively ) . Through week 48 , the proportions of patients with at least one adverse event ( AE ) were comparable among the treatment groups . Infections were the most common type of AE . Conclusions Treatment with ustekinumab or guselkumab did not significantly reduce the signs and symptoms of RA . No new safety findings were observed with either treatment . Trial registration number NCT01645280 To evaluate ixekizumab , an anti – interleukin‐17A ( anti – IL‐17A ) monoclonal antibody , in 2 population s of rheumatoid arthritis ( RA ) patients : biologics‐naive patients and patients with an inadequate response to tumor necrosis factor ( TNF ) inhibitors Objectives Mavrilimumab , a human monoclonal antibody targeting the alpha subunit of the granulocyte-macrophage colony-stimulating factor receptor , was evaluated in a phase 2 r and omised , double-blind , placebo-controlled study to investigate efficacy and safety in subjects with rheumatoid arthritis ( RA ) . Methods Subcutaneous mavrilimumab ( 10 mg , 30 mg , 50 mg , or 100 mg ) or placebo was administered every other week for 12 weeks in subjects on stable background methotrexate therapy . The primary endpoint was the proportion of subjects achieving a ≥1.2 decrease from baseline in Disease Activity Score ( DAS28-CRP ) at week 12 . Results 55.7 % of mavrilimumab-treated subjects met the primary endpoint versus 34.7 % placebo ( p=0.003 ) at week 12 ; for the 10 mg , 30 mg , 50 mg , and 100 mg groups , responses were 41.0 % ( p=0.543 ) , 61.0 % ( p=0.011 ) , 53.8 % ( p=0.071 ) , and 66.7 % ( p=0.001 ) respectively . Response rate differences from placebo were observed at week 2 and increased throughout the treatment period . The 100 mg dose demonstrated a significant effect versus placebo on DAS28-CRP<2.6 ( 23.1 % vs 6.7 % , p=0.016 ) , all categories of the American College of Rheumatology ( ACR ) criteria ( ACR20 : 69.2 % vs 40.0 % , p=0.005 ; ACR50 : 30.8 % vs 12.0 % , p=0.021 ; ACR70 : 17.9 % vs 4.0 % , p=0.030 ) , and the Health Assessment Question naire Disability Index ( −0.48 vs −0.25 , p=0.005 ) . A biomarker-based disease activity score showed a dose-dependent decrease at week 12 , indicating suppression of disease-related biological pathways . Adverse events were generally mild or moderate in intensity . No significant hypersensitivity reactions , serious or opportunistic infections , or changes in pulmonary parameters were observed . Conclusions Mavrilimumab induced rapid clinical ly significant responses in RA subjects , suggesting that inhibiting the mononuclear phagocyte pathway may provide a novel therapeutic approach for RA Background Placebo effect is one of the method ological difficulties in dry eye clinical trials . If we could eluci date the tendencies of the placebo response and find predictors , we could reduce the placebo response in clinical trials for dry eye . In this study , we investigated the predictive factors for the placebo effect in dry eye clinical trials . Methods A total of 205 patients with dry eye assigned to the placebo arms of three placebo-controlled r and omised clinical trials were analysed by simple and multivariable regression analysis . The corneal fluorescein ( FL ) staining score and dry eye symptoms were studied at week 4 . The variables of interest included gender , age , complications of Sjögren ’s syndrome , Schirmer ’s test I value , tear break-up time and conjunctival hyperaemia score . We also conducted a stratified analysis according to the patients ’ age . Results Among all the studied endpoints , the baseline scores were significantly related to the corresponding placebo response . In addition , for the FL score and the dryness score , age was a significant predictor of the placebo response ( p=0.04 and p<0.0001 , respectively ) . Stratified analysis by age showed that patients more than 40 years of age are more likely to have a stronger placebo response in the FL and dryness scores . Conclusion The baseline scores and age were predictive factors of the placebo response in frequently used endpoints , such as FL score or dryness symptoms . These patient characteristics can be controlled by study design , and our findings enable the design of more efficient placebo-controlled studies with good statistical power BACKGROUND Rheumatoid arthritis is a heterogeneous chronic disease , and no therapeutic agent has been identified which is universally and persistently effective in all patients . We investigated the effectiveness of tofacitinib ( CP-690,550 ) , a novel oral Janus kinase inhibitor , as a targeted immunomodulator and disease-modifying therapy for rheumatoid arthritis . METHODS We did a 6-month , double-blind , parallel-group phase 3 study at 82 centres in 13 countries , including North America , Europe , and Latin America . 399 patients aged 18 years or older with moderate-to-severe rheumatoid arthritis and inadequate response to tumour necrosis factor inhibitors ( TNFi ) were r and omly assigned in a 2:2:1:1 ratio with an automated internet or telephone system to receive twice a day treatment with : tofacitinib 5 mg ( n=133 ) ; tofacitinib 10 mg ( n=134 ) ; or placebo ( n=132 ) , all with methotrexate . At month 3 , patients given placebo advanced to either tofacitinib 5 mg twice a day ( n=66 ) or 10 mg twice a day ( n=66 ) . Primary endpoints included American College of Rheumatology (ACR)20 response rate , mean change from baseline in Health Assessment Question naire-Disability Index ( HAQ-DI ) , and rates of disease activity score (DAS)28 - 4(ESR ) less than 2·6 ( referred to as DAS28<2·6 ) , all at month 3 . The full analysis set for the primary analysis included all r and omised patients who received at least one dose of study medication and had at least one post-baseline assessment . This trial is registered with www . Clinical Trials.gov , number NCT00960440 . FINDINGS At month 3 , ACR20 response rates were 41·7 % ( 55 of 132 [ 95 % CI vs placebo 6·06 - 28·41 ] ; p=0·0024 ) for tofacitinib 5 mg twice a day and 48·1 % ( 64 of 133 ; [ 12·45 - 34·92 ] ; p<0·0001 ) for tofacitinib 10 mg twice a day versus 24·4 % ( 32 of 131 ) for placebo . Improvements from baseline in HAQ-DI were -0·43 ( [ -0·36 to -0·15 ] ; p<0·0001 ) for 5 mg twice a day and -0·46 ( [ -0·38 to -0·17 ] ; p<0·0001 ) for 10 mg twice a day tofacitinib versus -0·18 for placebo ; DAS28<2·6 rates were 6·7 % ( eight of 119 ; [ 0 - 10·10 ] ; p=0·0496 ) for 5 mg twice a day tofacitinib and 8·8 % ( 11 of 125 [ 1·66 - 12·60 ] ; p=0·0105 ) for 10 mg twice a day tofacitinib versus 1·7 % ( two of 120 ) for placebo . Safety was consistent with phase 2 and 3 studies . The most common adverse events in months 0 - 3 were diarrhoea ( 13 of 267 ; 4·9 % ) , nasopharyngitis ( 11 of 267 ; 4·1 % ) , headache ( 11 of 267 ; 4·1 % ) , and urinary tract infection ( eight of 267 ; 3·0 % ) across tofacitinib groups , and nausea ( nine of 132 ; 6·8 % ) in the placebo group . INTERPRETATION In this treatment-refractory population , tofacitinib with methotrexate had rapid and clinical ly meaningful improvements in signs and symptoms of rheumatoid arthritis and physical function over 6 months with manageable safety . Tofacitinib could provide an effective treatment option in patients with an inadequate response to TNFi . FUNDING Pfizer Abstract Objective . A phase IIa study investigated efficacy and safety/tolerability of ascending doses of mavrilimumab ( anti-granulocyte-macrophage colony-stimulating factor receptor [GM-CSFR]
Output:
| No background DMARD treatment was also a negative predictor ( albeit statistically non-significant ) .
Our meta- analysis suggests that study location , patient population , and a background DMARD treatment influence placebo ACR20 . |
MS211621 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies The purpose of this study was to compare the efficacy of overbite correction achieved by a conventional continuous arch wire technique and the segmented arch technique as recommended by Burstone . The sample comprised 50 adult patients ( age 18 to 40 years ) with deep bites . Twenty-five patients were treated with a continuous arch wire technique ( CAW ) ; in the second half of the sample , the segmented arch technique ( Burstone ) was used for correction of the vertical malocclusion . Lateral cephalograms and plaster cast models taken before and immediately after treatment were evaluated . Statistical analysis was performed on the collected data . The results showed that both techniques produced a highly significant overbite reduction ( CAW : -3.17 mm , p < 0.001 ; Burstone : -3.56 mm , p < 0.001 ) . The CAW group showed an extrusion in the molar area with subsequent posterior rotation of the m and ible ( 6occl-ML : + 1.30 mm ; 6occl-NSL : + 1.63 mm ; ML/NSL : + 1.94 degrees , all p < 0.001 ) . The Burstone group , however , showed overbite reduction by incisor intrusion without any substantial extrusion of posterior teeth ( upper 1-NSL : -1.50 mm ; lower 1-ML : -1.72 mm ; both p < 0.001 ) . As a consequence , no significant posterior rotation of the m and ible took place ( ML/NSL : + 0.52 degrees , n.s . ) . It is concluded that in adult patients the segmented arch technique ( Burstone ) can be considered as being superior to a conventional continuous arch wire technique if arch leveling by incisor intrusion is indicated INTRODUCTION The aim of this prospect i ve study was to compare the effects of incisor intrusion obtained with the aid of miniscrews and utility arches . METHODS Twenty-four patients ( 10 male , 14 female ) with a deepbite of at least 4 mm were divided to 2 groups . In group 1 , 13 patients ( 3 male , 10 female ; mean age , 20.90 ± 7.12 years ) in the postpubertal growth period were treated by using miniscrews ; in group 2 , 11 patients ( 7 male , 4 female ; mean age , 15.25 ± 3.93 years ) were treated with utility arches . Lateral cephalometric headfilms were taken at the beginning of treatment and after intrusion for the evaluation of the treatment changes . Statistical analyses of the data were performed with a significance level of P < 0.05 . RESULTS Intrusion lasted 6.61 ± 2.95 months for group 1 and 6.61 ± 2.46 months for group 2 . The changes in the center of resistance of the incisors were 1.75 ± 0.4 mm ( P < 0.05 ) for group 1 and 0.86 ± 0.5 mm ( P > 0.05 ) for group 2 ; the difference between the groups was significant ( P < 0.05 ) . In the miniscrew group , the incisors were protruded 0.79 ± 1.4 mm ( P > 0.05 ) relative to pterygoid vertical and 3.85 ° ± 2.4 ° ( P > 0.05 ) relative to the palatal plane . In group 2 , the incisors showed 3.91 ± 0.7 mm ( P < 0.05 ) of protrusion relative to pterygoid vertical and 13.55 ° ± 2.4 ° ( P < 0.05 ) relative to the palatal plane . The maxillary first molars showed significant distal tipping in group 2 ( P < 0.05 ) . CONCLUSIONS Unlike with utility arches , true maxillary incisor intrusion can be achieved by application of intrusive forces close to the center of resistance by using miniscrews with no counteractive movements in the molars
Output:
| This was statistically significant , but not clinical ly relevant .
No clinical difference was found between TADs and the conventional method of anchorage loss |
MS211622 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Purpose The aims of this study are to compare self-reported sleep quality in adult survivors of childhood brain tumors and a population -based comparison group , to identify treatment-related factors associated with sleep disturbances , and to identify the impact of post-treatment obesity and depression on sleep scores in adult survivors of childhood brain tumors . Methods R and omly selected adult survivors of childhood brain tumors ( n = 78 ) and age- , sex- , and zip code-matched population -group members ( n = 78 ) completed the Pittsburgh Sleep Quality Index and the Brief Symptom Inventory . Sleep quality and the effect of demographic , treatment , and post-treatment characteristics were evaluated with linear and logistic regression analyses . Results Brain tumor survivors were 2.7 ( 95 % CI , 1.1 , 6.5 ) times more likely than the comparison group to take greater than 30 min to fall asleep . Females in both groups reported worse sleep quality and impaired daytime functioning . Among survivors , post-treatment obesity was associated with daytime dysfunction . Conclusions These results agree with previous studies associating sleep , sex , and obesity and identified longer sleep latency as being a problem among childhood brain tumor survivors . Further study identifying factors contributing to sleep latency , and its impact on quality of life among adult survivors of childhood brain tumors is needed BACKGROUND Febrile neutropenia ( FN ) is a frequent , serious complication of intensive pediatric chemotherapy regimens . The aim of this trial was to compare quality of life ( QOL ) between inpatient and outpatient intravenous antibiotic management of children and adolescents with low risk febrile neutropenia ( LRFN ) . PROCEDURE In this r and omised non-blinded trial , patients between 1 and 21 years old , receiving low/moderate intensity chemotherapy were pre-consented and , on presentation to emergency ( ED ) with FN satisfying low risk criteria , r and omised to either outpatient or inpatient care with intravenous cefepime 50 mg/kg ( 12 hourly ) . All patients continued antibiotics for at least 48 hours , until afebrile for 24 hours and demonstrating a rising absolute neutrophil count ≥200/mm(3 ) . Several domains of QOL were examined by daily question naire . RESULTS Eighty-one patients presented to ED with 159 episodes of fever . Thirty-seven FN presentations involving 27 patients were r and omised to inpatient ( 18 ) and outpatient ( 19 ) management . Combined QOL mean scores for parents were higher for the outpatient group and scores for three specific parent variables ( keeping up with household tasks/time spent with partner/time spent with other children ) were higher among out patients . There was no difference in parent confidence/satisfaction in care between groups . Patients scored better in the outpatient group overall and for sleep and appetite . The mean length of fever was equivalent between groups and there were no serious adverse events attributable to cefepime or outpatient care . CONCLUSION Outpatient cefepime management of LRFN provided significant benefit to parents and patients across several QOL domains and appeared both feasible and safe PURPOSE / OBJECTIVES To determine the feasibility of collecting symptom data at home from school-age children with acute lymphoblastic leukemia ( ALL ) and from their fathers and mothers and to obtain initial descriptions of pain , sleep disturbance , and fatigue experienced by the family members at home . DESIGN Prospect i ve and descriptive . SETTING Children 's homes in Oregon and southwestern Washington . SAMPLE 9 children with ALL ( aged 8 - 16 years ) , 6 fathers , and 7 mothers . The children received vincristine during the maintenance phase of their outpatient chemotherapy treatments . METHODS With age-appropriate , paper- and -pencil diaries and wrist actigraphy , data were collected for three days in the families ' homes . Families were reminded by telephone to complete their sleep and activity diaries . MAIN RESEARCH VARIABLES Pain , sleep disturbance , and fatigue in school-age children and their fathers and mothers . FINDINGS Most of the families who were approached indicated willingness to participate in the study . After receiving outpatient chemotherapy , the children reported pain , sleep disturbance , and fatigue data over three days . Fathers and mothers also reported symptoms . Actigraphy showed children waking more often during the night than mothers or fathers . CONCLUSIONS Children 's pain , sleep disturbance , and fatigue suggest that the symptoms are influencing families ' quality of life . Larger studies are needed to examine the symptom patterns and health outcomes of children , fathers , and mothers over the course of chemotherapy . IMPLICATION S FOR NURSING Improving sleep and managing pain and fatigue after chemotherapy treatment for children with ALL may improve health outcomes for children and parents OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity 8523 Background : An increased risk for strokes has not been previously reported among HD survivors . This report examines the rate and risk factors for stroke in long-term survivors of HD . METHODS The CCSS is a multi-institutional cohort study of long-term ( ≥ 5 years ) survivors who were diagnosed between 1970 - 1986 . The rate of first occurrence of self-reported strokes was determined for HD survivors ( N=1665 ) and compared with a r and om sample of siblings of childhood cancer survivors ( N=3846 ) . The mean age at interview of the HD survivors was 31.9 years of age , with a mean age at diagnosis of 14.6 years . The incidence rates of HD survivors at ≥ 5 years post diagnosis and siblings were calculated separately . Cox proportional hazards models were used to estimate rate ratio ( RR ) of developing stroke between HD survivals and siblings . RESULTS Fifteen HD survivors reported a stroke : one during therapy , 13 occurring ≥ 5 years after HD diagnosis , and one without an age at stroke reported . The rate of stroke in HD survivors ≥ 5 years post diagnosis was 0.68 per 1000 person-years ( 95 % CI , 0.40 - 1.18 ) . Of the 13 late occurring strokes , all had chest/mantle radiation ( median dose 40 Gy ) , with a median interval of 15 years from HD diagnosis to stroke . The median age of stroke was 31 years ( range 21 - 40 ) . Seven siblings reported a previous stroke , with a rate of 0.069 per 1000 person-years ( 95 % CI , 0.03 - 0.15 ) . The RR of stroke for all HD survivors , in comparison with siblings , was 3.88 ( 95 % CI , 1.46 - 10.3 ; p = 0.0065 ) . The rate of stroke for HD survivors who were treated with chest radiation therapy ( RT ) was 0.82 per 1000 person-years ( 95 % CI , 0.48 - 1.41 ) . Compared to siblings , the RR of HD survivors treated with chest RT was 4.28 ( 95 % CI , 1.6 - 11.2 ; p=0.0031 ) . Anthracycline exposure , treatment with chemotherapy only , hypertension and diabetes mellitus were not associated with an increased risk of stroke . CONCLUSIONS Though an infrequent outcome , survivors of childhood HD may be at an increased risk of stroke . In this study , previous exposure to chest RT was strongly associated with risk of stroke . Because the risk may be modified by prevention , it is imperative to further study this process . No significant financial relationships to disclose PURPOSE Long-term survivors of childhood Hodgkin lymphoma ( HL ) are at risk for cardiopulmonary complications and CNS stroke , although neurocognitive function has not been previously examined . The aim of this study was to examine neurocognitive and brain imaging outcomes in adult survivors of childhood HL . PATIENTS AND METHODS In all , 62 adult survivors ( mean age , 42.2 years ; st and ard deviation [ SD ] , 4.77 ; mean age at diagnosis , 15.1 years ; SD , 3.30 ) were identified by stratified r and om selection from a large cohort treated with either high-dose ( ≥ 30 Gy ) thoracic radiation ( n = 38 ) or lower-dose ( < 30 Gy ) thoracic radiation combined with anthracycline ( n = 24 ) . Patients underwent neurocognitive evaluations , brain magnetic resonance imaging ( MRI ) , echocardiograms , pulmonary function tests , and physical examinations . RESULTS Compared with national age-adjusted norms , HL survivors demonstrated lower performance on sustained attention ( P = .004 ) , short-term memory ( P = .001 ) , long-term memory ( P = .006 ) , working memory ( P < .001 ) , naming speed ( P < .001 ) , and cognitive fluency ( P = .007 ) . MRI revealed leukoencephalopathy in 53 % of survivors , and 37 % had evidence of cerebrovascular injury . Higher thoracic radiation dose was associated with impaired cardiac diastolic function ( E/E ' ; ratio of peak mitral flow velocity of early rapid filling [ E ] to early diastolic velocity of the mitral annulus [ E ' ] ; P = .003 ) , impaired pulmonary function ( diffusing capacity of lungs for carbon monoxide [ DL(co)(corr ) ; P = .04 ) , and leukoencephalopathy ( P = .02 ) . Survivors with leukoencephalopathy demonstrated reduced cognitive fluency ( P = .001 ) . Working memory impairment was associated with E/E ' , although impaired sustained attention and naming speed were associated with DL(co)(corr ) . Neurocognitive performance was associated with academic and vocational functioning . CONCLUSION These results suggest that adult long-term survivors of childhood HL are at risk for neurocognitive impairment , which is associated with radiologic indices suggestive of reduced brain integrity and which occurs in the presence of symptoms of cardiopulmonary dysfunction This prospect i ve , two-site , r and omized , controlled pilot study assessed the feasibility of an enhanced physical activity ( EPA ) intervention in hospitalized children and adolescents receiving treatment for a solid tumor or for acute myeloid leukemia ( AML ) , and assessed different statistical techniques to detect the intervention 's sleep and fatigue outcomes . Twenty-nine patients ( 25 with a solid tumor and 4 with AML ) participated . Data were collected from actigraph ; patient , parent , and staff nurse reports of patient fatigue ; parent sleep diaries ; and patient charts . The intervention was successfully implemented 85.4 % of the scheduled times . We used two different statistical methods to analyze the longitudinal data . Using an ANOVA model , sleep was significantly more efficient in the experimental arm than in the control arm when daily differences from baseline sleep efficiency values were averaged and compared ( F=4.17 , P=0.053 ) . However , in a mixed model ( repeated measures ) analysis , sleep duration ( F=0.54 , P=0.47 ) and sleep efficiency ( F=0.04 , P=0.85 ) were not seen to differ between study arms . We conclude that an inpatient intervention of EPA can be delivered to children and adolescents receiving chemotherapy . Our findings identify design and statistical considerations for a future effectiveness study of the EPA intervention in hospitalized pediatric oncology patients PURPOSE / OBJECTIVES To examine the influence of the
Output:
| Data from objective and subjective assessment s of sleep showed that child sleep was disrupted in the hospital when compared to previously established age-related norms .
Noise , light levels , and staff room interruptions were associated with decreased total sleep minutes and increased nighttime awakenings .
This may help to minimize the role that hospitalization plays in precipitating and perpetuating chronic sleep disturbances in pediatric cancer patients . |
MS211623 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: To assess the value of improved monitoring of medication‐taking behavior in a drug trial , we employed a modified pill vial with microcircuitry to record the precise times when the vials were opened . After a 3‐week placebo washout period , 21 ambulatory subjects with mild hypertension ( mean age , 57 years ; 67 % men ; 76 % white ) r and omly received isradipine or enalapril twice daily in a double‐blind titration during 10 weeks . Both drugs achieved a 13 % reduction in sitting diastolic blood pressure ( p < 0.01 ) with minimal symptomatic or laboratory toxicity . Although pill counts indicated near‐perfect compliance ( 92 % to 99 % for both groups ) , the electronic monitor showed that fewer than half of all openings occurred at the prescribed interval of 12 ± 2 hours . Modest overdispensing was documented in the 3 days before scheduled visits . The monitor confirmed that pill count misclassified compliance sufficiency in 22 % of visits and permitted more discrete attribution for drug‐associated adverse reactions and secondary resistance to treatment . We conclude that the electronic monitor reduces ambiguity about medication compliance and helps interpret both the biology and pharmacology of the trial Background The objective of this study was to develop and psychometrically evaluate a general measure of patients ' satisfaction with medication , the Treatment Satisfaction Question naire for Medication ( TSQM ) . Methods The content and format of 55 initial questions were based on a formal conceptual framework , an extensive literature review , and the input from three patient focus groups . Patient interviews were used to select the most relevant questions for further evaluation ( n = 31 ) . The psychometric performance of items and result ing TSQM scales were examined using eight diverse patient groups ( arthritis , asthma , major depression , type I diabetes , high cholesterol , hypertension , migraine , and psoriasis ) recruited from a national longitudinal panel study of chronic illness ( n = 567 ) . Participants were then r and omized to complete the test items using one of two alternate scaling methods ( Visual Analogue vs. Likert-type ) . Results A factor analysis ( principal component extraction with varimax rotation ) of specific items revealed three factors ( Eigenvalues > 1.7 ) explaining 75.6 % of the total variance ; namely Side effects ( 4 items , 28.4 % , Cronbach 's Alpha = .87 ) , Effectiveness ( 3 items , 24.1 % , Cronbach 's Alpha = .85 ) , and Convenience ( 3 items , 23.1 % , Cronbach 's Alpha = .87 ) . A second factor analysis of more generally worded items yielded a Global Satisfaction scale ( 3 items , Eigenvalue = 2.3 , 79.1 % , Cronbach 's Alpha = .85 ) . The final four scales possessed good psychometric properties , with the Likert-type scaling method performing better than the VAS approach . Significant differences were found on the TSQM by the route of medication administration ( oral , injectable , topical , inhalable ) , level of illness severity , and length of time on medication . Regression analyses using the TSQM scales accounted for 40–60 % of variation in patients ' ratings of their likelihood to persist with their current medication . Conclusion The TSQM is a psychometrically sound and valid measure of the major dimensions of patients ' satisfaction with medication . Preliminary evidence suggests that the TSQM may also be a good predictor of patients ' medication adherence across different types of medication and patient population BACKGROUND Adherence is essential to a positive treatment outcome . Whether adequate doses of topically applied drugs are used among patients with dermatologic conditions has not been investigated adequately . OBJECTIVES The objective of this prospect i ve study was to determine to what extent first-time out patients with dermatologic conditions apply the appropriate dosage of initial treatment with topically administered medication . METHODS Consultations with first-time patients in the dermatologic outpatient clinic were observed . Patients receiving a prescription for a previously untried topically administered drug were eligible . The expected quantity of topical treatment to be used by each patient was calculated from the affected skin area to be treated . The affected area was estimated in numbers of palms of the h and , and an amount of 0.25 g of ointment or cream was chosen as sufficient treatment to cover the area of one palm . Two weeks after the consultation , a question naire with items regarding the size of the affected area , intentions to follow the treatment , and the applied dose the previous day was mailed to each patient . The question naires were personally collected from the patients ' homes and at the same visit the patients ' topical drug containers were weighed on a balance . Both patients and staff were blinded to the particular study purpose concerning adherence and dosing . RESULTS In all , 17 patients were eligible . The majority received a prescription for topical corticosteroids , and the median area to be treated was 3 palms of the h and ( interquartile range : 1.5 - 8 ) . Two patients did not redeem their prescriptions . Only one patient used the expected dosage ; in general median 35 % ( interquartile range : 22%-50 % ) of the expected individual dosages were used . LIMITATIONS Only first-time patients who received a new and previously untried topical treatment were included , result ing in a small study size . CONCLUSIONS Most first-time patients with dermatologic conditions underdose new topical treatments . Consequently , clinicians should always consider nonadherence when topical therapies fail The objective of this study was to develop a prospect ively applicable method for classifying comorbid conditions which might alter the risk of mortality for use in longitudinal studies . A weighted index that takes into account the number and the seriousness of comorbid disease was developed in a cohort of 559 medical patients . The 1-yr mortality rates for the different scores were : " 0 " , 12 % ( 181 ) ; " 1 - 2 " , 26 % ( 225 ) ; " 3 - 4 " , 52 % ( 71 ) ; and " greater than or equal to 5 " , 85 % ( 82 ) . The index was tested for its ability to predict risk of death from comorbid disease in the second cohort of 685 patients during a 10-yr follow-up . The percent of patients who died of comorbid disease for the different scores were : " 0 " , 8 % ( 588 ) ; " 1 " , 25 % ( 54 ) ; " 2 " , 48 % ( 25 ) ; " greater than or equal to 3 " , 59 % ( 18 ) . With each increased level of the comorbidity index , there were stepwise increases in the cumulative mortality attributable to comorbid disease ( log rank chi 2 = 165 ; p less than 0.0001 ) . In this longer follow-up , age was also a predictor of mortality ( p less than 0.001 ) . The new index performed similarly to a previous system devised by Kaplan and Feinstein . The method of classifying comorbidity provides a simple , readily applicable and valid method of estimating risk of death from comorbid disease for use in longitudinal studies . Further work in larger population s is still required to refine the approach because the number of patients with any given condition in this study was relatively small OBJECTIVE To assess patient compliance with psoriasis treatment . DESIGN Open prospect i ve study . Patients with psoriasis were examined and completed a brief medical and social history , a compliance assessment sheet , and the Dermatology Life Quality Index ( DLQI ) . Patients were reexamined at 3 months , and their actual treatment use was assessed and compared with the expected use . Medication adherence was assessed by direct question ing . SETTING Dermatology outpatient clinic . PATIENTS Two hundred ninety-four patients fulfilled the inclusion criteria , and 201 completed the study . MAIN OUTCOME MEASURE Adherence with topical and oral therapies , using objective and self-reporting methods and description of factors affecting compliance . RESULTS The overall mean + /- SD medication adherence was 60.6 % + /- 33.0 % ( range , 0%-169 % ) . The mean + /- SD DLQI in the study was 17.4 + /- 8.9 ( range , 0 - 30 ) . There was a highly significant negative correlation ( r = -0.92 ) between these variables . Being female , married , employed , and not paying for prescriptions were characteristics associated with increased medication adherence and a lower DLQI . Medication adherence was greater for topical or combined therapy , for once-daily treatment , and for first-time use of treatment . Adverse effects reduced compliance . The major reasons for missing treatment were drinking alcohol , being fed up , forgetfulness , and being too busy . Patients with facial disease and with more extensive disease had lower medication adherence . CONCLUSIONS A range of disease-related and social factors may affect compliance with psoriasis treatment . The inversely proportional relationship between DLQI and medication adherence reflects the interaction of physical and psychological factors , as well as perceived treatment failure BACKGROUND In the treatment of psoriasis , patient adherence to oral medications is poor and even worse for topical therapy . However , few data exist about adherence rates to home phototherapy , adding to concerns about the appropriateness of home phototherapy as a psoriasis treatment option . OBJECTIVE We sought to assess adherence to both oral acitretin and home ultraviolet B phototherapy for the treatment of psoriasis . METHODS In all , 27 patients with moderate to severe psoriasis were treated with 10 to 25 mg of acitretin daily , combined with narrowb and ultraviolet B , 3 times weekly at home , for 12 weeks . Adherence to acitretin was monitored by an electronic monitoring medication bottle cap , and to phototherapy by a light-sensing data logger . RESULTS Adherence data were collected on 22 patients for acitretin and 16 patients for adherence to ultraviolet B. Mean adherence to acitretin decreased steadily during the 12-week trial ( slope -0.24 ) , whereas mean adherence to home phototherapy remained steady at 2 to 3 d/wk . Adherence was similar between patients who reported side effects and those who did not . LIMITATIONS Small sample size and lack of follow-up on some patients were limitations of this study . CONCLUSIONS Adherence rates to home phototherapy were very good and higher than adherence rates for the oral medication . Side effects of treatment were well tolerated in this small group and did not affect use of the treatment . Home phototherapy with acitretin may be an appropriate option for some patients with extensive psoriasis INTRODUCTION Medication nonadherence is common throughout medicine , and research into this area is increasing ; however , knowledge about topical medication adherence is limited . METHODS A total of 30 patients were enrolled in a clinical trial for psoriasis and followed up for 8 weeks using 3 methods of adherence monitoring : electronic monitoring caps ; medication logs ; and medication usage by weight . RESULTS Adherence rates calculated from the medication logs and medication weights were consistently higher than those of the electronic monitors ( P < .05 ) . Electronically measured adherence rates declined from 84.6 % to 51 % during the 8-week study ( P < .0001 ) . Female sex and increasing age by 1 year predicted improved adherence of 5 % and 0.8 % , respectively ( P < .0001 ) . The number of treatment gaps increased from the first half to the last half of the study , and weekend days were overrepresented in treatment gaps . CONCLUSION Medication logs and weights do not ensure medication adherence to topical therapy . Electronic monitoring allows a more precise method of adherence measurement BACKGROUND A group of vitamin D derivatives has revealed to be an efficient treatment for psoriasis . Different types of studies have been design ed to confirm the efficacy of its use without relevant side-effects . OBJECTIVE Evaluation of tolerability and efficacy of tacalcitol ointment in moderate psoriasis . DESIGN A 2-month multicentre prospect i ve open-label observational study in patients with psoriasis treated with tacalcitol ointment . METHODS A cohort of patients with psoriasis vulgaris seeking medical advice and being treated with tacalcitol based on the decision of their dermatologists was selected . A 2-month follow-up was performed to assess efficacy and tolerability of tacalcitol in an ointment formulation ( 4 microg/g ) once daily . A psoriatic lesion was selected in each patient in order to assess clinical symptoms ( erythema , desquamation and thickness ) by means of five-point scale : 0 ( none ) to 4 ( maximal severity ) . Percentages of involved skin , adverse effects , physicians ' global assessment s of efficacy and tolerability , and patients ' global satisfaction scores were also evaluated after 15 - 30 days ( first visit ) and 2 months ( second visit ) of treatment . RESULTS A total of 556 patients were included . Mean psoriasis duration was 10.1 years ( range , 0 - 61 years ) . Follow-up data were available for 493 patients in first follow-up visit and 449 in second ( final ) visit . Adverse events were uncommon ( 1.0 % and 0.6 % of patients in first and second follow-up visits , respectively ) . At first follow-up visit , mean decrease in selected lesions surface area ( from a baseline value of 185.8 cm(2 ) per lesion ) was 11.1 cm(2 ) ( 95 % CI , 1.6 - 20.6 ; P = 0.0213 ) . After 2 months of treatment , mean scores for erythema , desquamation and thickness changed from 2
Output:
| No consistent pattern of results emerged for sociodemographical , disease and lifestyle factors as determinants of adherence .
However , some treatment factors were associated with adherence .
While mixed findings were reported for quality of life as a determinant of adherence , psychological factors ( psychological distress and patient satisfaction with care and therapy ) were associated with adherence . |
MS211624 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Neo-adjuvant chemoradiotherapy followed by surgery is the st and ard treatment with curative intent for oesophageal cancer patients , with 5-year overall survival rates up to 50 % . However , patients ’ quality of life is severely compromised by oesophagectomy , and eventually many patients die due to metastatic disease . Most solid tumours , including oesophageal cancer , contain hypoxic regions that are more resistant to chemoradiotherapy . The hypoxia-activated prodrug evofosfamide works as a DNA-alkylating agent under these hypoxic conditions , which directly kills hypoxic cancer cells and potentially minimizes resistance to conventional therapy . This drug has shown promising results in several clinical studies when combined with chemotherapy . Therefore , in this phase I study we investigate the safety of evofosfamide added to the chemoradiotherapy treatment of oesophageal cancer . Methods / Design A phase I , non-r and omized , single-centre , open-label , 3 + 3 trial with repeated hypoxia PET imaging , will test the safety of evofosfamide in combination with neo-adjuvant chemoradiotherapy in potentially resectable oesophageal adenocarcinoma patients . Investigated dose levels range from 120 mg/m2 to 340 mg/m2 . Evofosfamide will be administered one week before the start of chemoradiotherapy ( CROSS-regimen ) and repeated weekly up to a total of six doses . PET/CT acquisitions with hypoxia tracer 18F-HX4 will be made before and after the first administration of evofosfamide , allowing early assessment of changes in hypoxia , accompanied with blood sampling to measure hypoxia blood biomarkers . Oesophagectomy will be performed according to st and ard clinical practice .Higher grade and uncommon non-haematological , haematological , and post-operative toxicities are the primary endpoints according to the CTCAEv4.0 and Clavien-Dindo classifications . Secondary endpoints are reduction in hypoxic fraction based on 18F-HX4 imaging , pathological complete response , histopathological negative circumferential resection margin ( R0 ) rate , local and distant recurrence rate , and progression free and overall survival . Discussion This is the first clinical trial testing evofosfamide in combination with chemoradiotherapy . The primary objective is to determine the dose limiting toxicity of this combined treatment and herewith to define the maximum tolerated dose and recommended phase 2 dose for future clinical studies . The addition of non-invasive repeated hypoxia imaging ( ‘ window-of-opportunity ’ ) enables us to identify the biologically effective dose . We believe this approach could also be used for other hypoxia targeted drugs . Trial registration Clinical Trials.gov Identifier : NCT02598687 Background and purpose Increased tumour hypoxia is associated with a worse overall survival in patients with head and neck squamous cell carcinoma ( HNSCC ) . The aims of this study were to evaluate treatment-associated changes in [18F]HX4-PET , hypoxia-related blood biomarkers , and their interdependence . Material and methods [18F]HX4-PET/CT scans of 20 patients with HNSCC were acquired at baseline and after ±20Gy of radiotherapy . Within the gross-tumour-volumes ( GTV ; primary and lymph nodes ) , mean and maximum st and ardized uptake values , the hypoxic fraction ( HF ) and volume ( HV ) were calculated . Also , the changes in spatial uptake pattern were evaluated using [18F]HX4-PET/CT imaging . For all patients , the plasma concentration of CAIX , osteopontin and VEGF was assessed . Results At baseline , tumour hypoxia was detected in 69 % ( 22/32 ) of the GTVs . During therapy , we observed a significant decrease in all image parameters . The HF decreased from 21.7 ± 19.8 % ( baseline ) to 3.6 ± 10.0 % ( during treatment ; P < 0.001 ) . Only two patients had a HV > 1 cm3 during treatment , which was located for > 98 % within the baseline HV . During treatment , no significant changes in plasma CAIX or VEGF were observed , while osteopontin was increased . Conclusions [18F]HX4-PET/CT imaging allows monitoring changes in hypoxia during (chemo)radiotherapy whereas the blood biomarkers were not able to detect a treatment-associated decrease in hypoxia Purpose Hypoxia is an important factor influencing tumor progression and treatment efficacy . The aim of this study was to investigate the repeatability of hypoxia PET imaging with [18F]HX4 in patients with head and neck and lung cancer . Methods Nine patients with lung cancer and ten with head and neck cancer were included in the analysis ( NCT01075399 ) . Two sequential pretreatment [18F]HX4 PET/CT scans were acquired within 1 week . The maximal and mean st and ardized uptake values ( SUVmax and SUVmean ) were defined and the tumor-to- background ratios ( TBR ) were calculated . In addition , hypoxic volumes were determined as the volume of the tumor with a TBR > 1.2 ( HV1.2 ) . Bl and Altman analysis of the uptake parameters was performed and coefficients of repeatability were calculated . To evaluate the spatial repeatability of the uptake , the PET/CT images were registered and a voxel-wise comparison of the uptake was performed , providing a correlation coefficient . Results All parameters of [18F]HX4 uptake were significantly correlated between scans : SUVmax ( r = 0.958 , p < 0.001 ) , SUVmean ( r = 0.946 , p < 0.001 ) , TBRmax ( r = 0.962 , p < 0.001 ) and HV1.2 ( r = 0.995 , p < 0.001 ) . The relative coefficients of repeatability were 15 % ( SUVmean ) , 17 % ( SUVmax ) and 17 % ( TBRmax ) . Voxel-wise analysis of the spatial uptake pattern within the tumors provided an average correlation of 0.65 ± 0.14 . Conclusion Repeated hypoxia PET scans with [18F]HX4 provide reproducible and spatially stable results in patients with head and neck cancer and patients with lung cancer . [18F]HX4 PET imaging can be used to assess the hypoxic status of tumors and has the potential to aid hypoxia-targeted treatments Background and purpose Noninvasive PET imaging of tumour hypoxia could help in the selection of those patients who could benefit from chemotherapy or radiation with specific antihypoxic treatments such as bioreductive drugs or hypoxic radiosensitizers . In this phase I trial , we aim ed to determine the toxicity of [18F]HX4 , a member of the 2-nitroimidazole family , at different dose levels . The secondary aim was to analyse image quality related to the HX4 dose and the timing of imaging . Methods Patients with a histologically proven solid cancer without curative treatment options were eligible for this study . A study design with two dose steps was used in which a single dose of a maximum of 222 MBq ( step 1 ) or 444 MBq ( step 2 ) [18F]HX4 was injected . Toxicity was scored on day 0 and on days 3 and 7 after injection , according to the CTCAE 3.0 scoring system . PET/CT images of the largest tumour site were acquired 30 , 60 and 120 min after injection . Results Six patients with stage IV carcinoma were included , four with non-small-cell lung carcinoma , one with thymus carcinoma , and one with colon carcinoma . No toxicity was observed in any of the patients at either dose level . The median tumour to muscle ratio 120 min after injection was 1.40 ( range 0.63–1.98 ) . Conclusion The findings of this study showed that [18F]HX4 PET imaging for the detection of hypoxia is not associated with any toxicity . Imaging was successful ; however , future trials are needed to determine the optimal image parameters BACKGROUND The role of neoadjuvant chemoradiotherapy in the treatment of patients with esophageal or esophagogastric-junction cancer is not well established . We compared chemoradiotherapy followed by surgery with surgery alone in this patient population . METHODS We r and omly assigned patients with resectable tumors to receive surgery alone or weekly administration of carboplatin ( doses titrated to achieve an area under the curve of 2 mg per milliliter per minute ) and paclitaxel ( 50 mg per square meter of body-surface area ) for 5 weeks and concurrent radiotherapy ( 41.4 Gy in 23 fractions , 5 days per week ) , followed by surgery . RESULTS From March 2004 through December 2008 , we enrolled 368 patients , 366 of whom were included in the analysis : 275 ( 75 % ) had adenocarcinoma , 84 ( 23 % ) had squamous-cell carcinoma , and 7 ( 2 % ) had large-cell undifferentiated carcinoma . Of the 366 patients , 178 were r and omly assigned to chemoradiotherapy followed by surgery , and 188 to surgery alone . The most common major hematologic toxic effects in the chemoradiotherapy-surgery group were leukopenia ( 6 % ) and neutropenia ( 2 % ) ; the most common major nonhematologic toxic effects were anorexia ( 5 % ) and fatigue ( 3 % ) . Complete resection with no tumor within 1 mm of the resection margins ( R0 ) was achieved in 92 % of patients in the chemoradiotherapy-surgery group versus 69 % in the surgery group ( P<0.001 ) . A pathological complete response was achieved in 47 of 161 patients ( 29 % ) who underwent resection after chemoradiotherapy . Postoperative complications were similar in the two treatment groups , and in-hospital mortality was 4 % in both . Median overall survival was 49.4 months in the chemoradiotherapy-surgery group versus 24.0 months in the surgery group . Overall survival was significantly better in the chemoradiotherapy-surgery group ( hazard ratio , 0.657 ; 95 % confidence interval , 0.495 to 0.871 ; P=0.003 ) . CONCLUSIONS Preoperative chemoradiotherapy improved survival among patients with potentially curable esophageal or esophagogastric-junction cancer . The regimen was associated with acceptable adverse-event rates . ( Funded by the Dutch Cancer Foundation [ KWF Kankerbestrijding ] ; Netherl and s Trial Register number , NTR487 . ) BACKGROUND AND PURPOSE In a phase III trial in patients with advanced stage laryngeal carcinoma comparing ARCON ( accelerated radiotherapy with carbogen breathing and nicotinamide ) to accelerated radiotherapy alone ( AR ) the prognostic and predictive value of CAIX , a hypoxia-associated protein , was investigated . MATERIAL AND METHODS 261 Paraffin embedded tumor biopsies and 79 fresh frozen biopsies from patients entered in the trial were immunohistochemically stained for CAIX . CAIX-fraction and CAIX expression pattern were related to tumor control and patient survival . RESULTS Low CAIX-fraction was prognostic for worse regional control and overall survival in patients treated with AR . Patients with a low CAIX-fraction treated with ARCON had better regional control and metastasis-free survival compared to AR ( RC 97 % vs 71 % , p < 0.01 and MFS 92 % vs 69 % , p = 0.06 ) . Patients with a perinecrotic CAIX staining pattern had a significantly worse local control , metastasis-free and overall survival compared to patients with a diffuse pattern ( 65 % vs 84 % , p = 0.01 , 70 % vs 96 % , p < 0.01 and 42 % vs 71 % , p < 0.01 respectively ) , and this could not be improved with ARCON . After multivariate analysis CAIX pattern and N-stage emerged as significant predictors for metastasis-free survival and overall survival . CONCLUSIONS ARCON improves regional control and metastasis-free survival only in patients with low CAIX expression . The different patterns of CAIX expression suggest different mechanisms of upregulation and have important prognostic value
Output:
| RESULTS In esophageal cancer , several (non-)invasive biomarkers for hypoxia could be identified .
Independent prognostic factors for treatment response include HIF-1α , CA IX , GLUT-1 overexpression and elevated uptake of the PET-tracer 18F-fluoroerythronitroimidazole ( 18F-FETNIM ) .
Hypoxia-associated molecular responses represents a clinical ly relevant phenomenon in esophageal cancer and detection of elevated levels of hypoxia-associated biomarkers and tends to be associated with poor treatment outcome ( i.e. , overall survival , disease-free survival , complete response and local control ) . |
MS211625 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: CONTEXT Many observational studies have shown that physical activity reduces the risk of cognitive decline ; however , evidence from r and omized trials is lacking . OBJECTIVE To determine whether physical activity reduces the rate of cognitive decline among older adults at risk . DESIGN AND SETTING R and omized controlled trial of a 24-week physical activity intervention conducted between 2004 and 2007 in metropolitan Perth , Western Australia . Assessors of cognitive function were blinded to group membership . PARTICIPANTS We recruited volunteers who reported memory problems but did not meet criteria for dementia . Three hundred eleven individuals aged 50 years or older were screened for eligibility , 89 were not eligible , and 52 refused to participate . A total of 170 participants were r and omized and 138 participants completed the 18-month assessment . INTERVENTION Participants were r and omly allocated to an education and usual care group or to a 24-week home-based program of physical activity . MAIN OUTCOME MEASURE Change in Alzheimer Disease Assessment Scale-Cognitive Subscale ( ADAS-Cog ) scores ( possible range , 0 - 70 ) over 18 months . RESULTS In an intent-to-treat analysis , participants in the intervention group improved 0.26 points ( 95 % confidence interval , -0.89 to 0.54 ) and those in the usual care group deteriorated 1.04 points ( 95 % confidence interval , 0.32 to 1.82 ) on the ADAS-Cog at the end of the intervention . The absolute difference of the outcome measure between the intervention and control groups was -1.3 points ( 95 % confidence interval,-2.38 to -0.22 ) at the end of the intervention . At 18 months , participants in the intervention group improved 0.73 points ( 95 % confidence interval , -1.27 to 0.03 ) on the ADAS-Cog , and those in the usual care group improved 0.04 points ( 95 % confidence interval , -0.46 to 0.88 ) . Word list delayed recall and Clinical Dementia Rating sum of boxes improved modestly as well , whereas word list total immediate recall , digit symbol coding , verbal fluency , Beck depression score , and Medical Outcomes 36-Item Short-Form physical and mental component summaries did not change significantly . CONCLUSIONS In this study of adults with subjective memory impairment , a 6-month program of physical activity provided a modest improvement in cognition over an 18-month follow-up period . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12605000136606 BACKGROUND Cognitive decline among seniors is a pressing health care issue . Specific exercise training may combat cognitive decline . We compared the effect of once-weekly and twice-weekly resistance training with that of twice-weekly balance and tone exercise training on the performance of executive cognitive functions in senior women . METHODS In this single-blinded r and omized trial , 155 community-dwelling women aged 65 to 75 years living in Vancouver were r and omly allocated to once-weekly ( n = 54 ) or twice-weekly ( n = 52 ) resistance training or twice-weekly balance and tone training ( control group ) ( n = 49 ) . The primary outcome measure was performance on the Stroop test , an executive cognitive test of selective attention and conflict resolution . Secondary outcomes of executive cognitive functions included set shifting as measured by the Trail Making Tests ( parts A and B ) and working memory as assessed by verbal digit span forward and backward tests . Gait speed , muscular function , and whole-brain volume were also secondary outcome measures . RESULTS Both resistance training groups significantly improved their performance on the Stroop test compared with those in the balance and tone group ( P < or = .03 ) . Task performance improved by 12.6 % and 10.9 % in the once-weekly and twice-weekly resistance training groups , respectively ; it deteriorated by 0.5 % in the balance and tone group . Enhanced selective attention and conflict resolution was significantly associated with increased gait speed . Both resistance training groups demonstrated reductions in whole-brain volume compared with the balance and tone group at the end of the study ( P < or = .03 ) . CONCLUSION Twelve months of once-weekly or twice-weekly resistance training benefited the executive cognitive function of selective attention and conflict resolution among senior women . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00426881 BACKGROUND Cognitive impairment that does not meet the criteria for dementia ( " Cognitive Impairment , No Dementia " -- CIND ) is a heterogeneous category with an increased risk of dementia . While greater physical activity is generally associated with a lower odds of both dementia and CIND , whether this effect applies across subgroups is not known . OBJECTIVES To investigate the association between physical activity and the risk of vascular CIND ( VCI-ND ) or mild cognitive impairment ( MCI ) . METHODS In the Canadian Study of Health and Aging community-dwelling cohort , of 4683 people who were not impaired at baseline , 3945 remained without cognitive impairment at 5 years , 454 were diagnosed with CIND , and 284 with dementia . Incident CIND and VCI-ND ( n=163 ) and MCI ( n=100 ) subtypes were investigated in relation to baseline physical activity , stratified by sex . RESULTS In women , moderate-high exercise was associated with a lower odds of CIND ( OR=0.62 , 95 % CI=0.46 - 0.84 ) and VCI-ND ( 0.34 , 0.18 - 0.63 ) relative to low exercise . There was no association for men or for MCI . CONCLUSION Exercise appears to reduce the risk of VCI-ND in women . Whether the lack of an effect of exercise on the odds of MCI reflects that ' prevented AD ' is indistinguishable from MCI is an intriguing possibility that merits further study OBJECTIVES To examine the effects of aerobic exercise on cognition and other biomarkers associated with Alzheimer disease pathology for older adults with mild cognitive impairment , and assess the role of sex as a predictor of response . DESIGN Six-month , r and omized , controlled , clinical trial . SETTING Veterans Affairs Puget Sound Health Care System clinical research unit . PARTICIPANTS Thirty-three adults ( 17 women ) with amnestic mild cognitive impairment ranging in age from 55 to 85 years ( mean age , 70 years ) . Intervention Participants were r and omized either to a high-intensity aerobic exercise or stretching control group . The aerobic group exercised under the supervision of a fitness trainer at 75 % to 85 % of heart rate reserve for 45 to 60 min/d , 4 d/wk for 6 months . The control group carried out supervised stretching activities according to the same schedule but maintained their heart rate at or below 50 % of their heart rate reserve . Before and after the study , glucometabolic and treadmill tests were performed and fat distribution was assessed using dual-energy x-ray absorptiometry . At baseline , month 3 , and month 6 , blood was collected for assay and cognitive tests were administered . MAIN OUTCOME MEASURES Performance measures on Symbol-Digit Modalities , Verbal Fluency , Stroop , Trails B , Task Switching , Story Recall , and List Learning . Fasting plasma levels of insulin , cortisol , brain-derived neurotrophic factor , insulinlike growth factor-I , and beta-amyloids 40 and 42 . RESULTS Six months of high-intensity aerobic exercise had sex-specific effects on cognition , glucose metabolism , and hypothalamic-pituitary-adrenal axis and trophic activity despite comparable gains in cardiorespiratory fitness and body fat reduction . For women , aerobic exercise improved performance on multiple tests of executive function , increased glucose disposal during the metabolic clamp , and reduced fasting plasma levels of insulin , cortisol , and brain-derived neurotrophic factor . For men , aerobic exercise increased plasma levels of insulinlike growth factor I and had a favorable effect only on Trails B performance . CONCLUSIONS This study provides support , using rigorous controlled methodology , for a potent nonpharmacologic intervention that improves executive control processes for older women at high risk of cognitive decline . Moreover , our results suggest that a sex bias in cognitive response may relate to sex-based differences in glucometabolic and hypothalamic-pituitary-adrenal axis responses to aerobic exercise The hippocampus shrinks in late adulthood , leading to impaired memory and increased risk for dementia . Hippocampal and medial temporal lobe volumes are larger in higher-fit adults , and physical activity training increases hippocampal perfusion , but the extent to which aerobic exercise training can modify hippocampal volume in late adulthood remains unknown . Here we show , in a r and omized controlled trial with 120 older adults , that aerobic exercise training increases the size of the anterior hippocampus , leading to improvements in spatial memory . Exercise training increased hippocampal volume by 2 % , effectively reversing age-related loss in volume by 1 to 2 y. We also demonstrate that increased hippocampal volume is associated with greater serum levels of BDNF , a mediator of neurogenesis in the dentate gyrus . Hippocampal volume declined in the control group , but higher preintervention fitness partially attenuated the decline , suggesting that fitness protects against volume loss . Cau date nucleus and thalamus volumes were unaffected by the intervention . These theoretically important findings indicate that aerobic exercise training is effective at reversing hippocampal volume loss in late adulthood , which is accompanied by improved memory function We report secondary findings from a r and omized controlled trial on the effects of exercise on memory in older adults with probable MCI . We r and omized 86 women aged 70–80 years with subjective memory complaints into one of three groups : resistance training , aerobic training , or balance and tone ( control ) . All participants exercised twice per week for six months . We measured verbal memory and learning using the Rey Auditory Verbal Learning Test ( RAVLT ) and spatial memory using a computerized test , before and after trial completion . We found that the aerobic training group remembered significantly more items in the loss after interference condition of the RAVLT compared with the control group after six months of training . In addition , both experimental groups showed improved spatial memory performance in the most difficult condition where they were required to memorize the spatial location of three items , compared with the control group . Lastly , we found a significant correlation between spatial memory performance and overall physical capacity after intervention in the aerobic training group . Taken together , our results provide support for the prevailing notion that exercise can positively impact cognitive functioning and may represent an effective strategy to improve memory in those who have begun to experience cognitive decline Self-reported rates of participation in sport vary by country . In the UK , about 40 % of men and women aged 16 years or older participate in at least one sport every week . Although few data exist to assess trends for participation in sport , there is little evidence of change in the past decade among adults . Large cohort studies suggest that such participation in sport is associated with a 20 - 40 % reduction in all-cause mortality compared with non-participation . R and omised trials and crossover clinical studies suggest that playing sport is associated with specific health benefits . Some sports have relatively high injury risk although neuromuscular training programmes can prevent various lower extremity injuries . Clinicians can influence a large number of patients through brief interventions that promote physical activity , and encouragement toward participation in sport for some physically inactive patients qualifies as evidence -based therapy . Exercise might also be considered as a fifth vital sign and should be recorded in patients ' electronic medical records and routine histories
Output:
| Adding fuel to the fire are publications such as a 2013 systematic review of r and omised controlled trials ( RCTs ) ( prior to 31 October 2011 ) reporting ‘ weak ’ evidence for the effects of exercise on cognition.4 We must highlight that the search strategy used in that systematic review failed to capture many pertinent papers providing evidence from RCTs that exercise promotes cognitive and brain plasticity not only in healthy older adults but also in those with cognitive impairment . |
MS211626 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A speech processing algorithm was developed to create more salient versions of the rapidly changing elements in the acoustic waveform of speech that have been shown to be deficiently processed by language -learning impaired ( LLI ) children . LLI children received extensive daily training , over a 4-week period , with listening exercises in which all speech was translated into this synthetic form . They also received daily training with computer “ games ” design ed to adaptively drive improvements in temporal processing thresholds . Significant improvements in speech discrimination and language comprehension abilities were demonstrated in two independent groups of LLI children This paper reports on the development and evaluation of a software program aim ed at assisting children with phonological impairment . An experimental approach was used whereby children 's speech output was assessed pre- and post-therapy . Children were r and omly assigned to a computer , a tabletop or a no therapy group . Those children receiving the computer therapy were exposed to an experimental software program that mirrored the tabletop activities using interactive computer games . The results showed no significant difference between any of the three groups with regard to change in speech output . These results may relate to the amount and frequency of therapy given and also to the heterogeneous nature of children included in the study . There was considerable variation in individual performance across all three groups and the data were therefore analysed to look for patterns that might predict performance . Stimulability and gender were identified as possible predictors . Female children and those who were able to produce a greater number of consonant speech sounds in isolation were more likely to make progress in their speech output . Future research might use a similar methodology to compare the therapy conditions but with a more homogenous group in terms of stimulability and using a greater intensity of intervention The current study was conducted to test the premise that computer-based intervention that targets auditory temporal processing combined with language exercises ( Fast ForWord ) is effective in remediating children with disorders of language and reading . Sixty-five middle school struggling readers were r and omly assigned to one of five groups and over a 12-week-period received one of the following interventions : ( 1 ) two phases of intervention with Fast ForWord ( FFW , experimental group ) , ( 2 ) two phases of intervention with SuccessMaker ( SM , active control group ) , ( 3 ) FFW followed by SM , ( 4 ) SM followed by FFW , or ( 5 ) no intervention beyond the regular class curriculum ( developmental control group ) . Changes in reading , phonemic awareness , spelling and language skills were assessed via a repeated measures MANOVA . Results indicated significant within-subjects effects ( i.e. , change for all participants over time ) , but no between-subject group differences , failing to show that Fast ForWord result ed in any gains over and above those seen in the other groups BACKGROUND Receptive language impairments in school-age children have a poor prognosis , yet there is a dearth of research on effective interventions . AIMS Children 's responses to a computerized grammatical training program were evaluated to consider whether repeated responding to spoken sentences with variable semantic content and the same syntactic structure would lead to consistent and fluent comprehension . METHODS & PROCEDURES Children with receptive language impairments aged from 8 to 13 years were r and omly assigned to three groups : Group S ( n = 12 ) responded to reversible sentences in a computerized game , using speech stimuli with pauses before critical phrases . Group M ( n = 12 ) had the same stimuli acoustically modified to lengthen and amplify dynamic portions of the signal . Group U ( n = 9 ) was an untrained control group . On average , children in groups S and M completed over 1000 training trials , focusing on training comprehension of reversible sentences . OUTCOMES & RESULTS Although responses speeded up over the course of training , and most children performed well above chance , accuracy typically remained below 95 % correct for constructions such as above/below and reversible active/passive . Trained groups did not differ from untrained children on language or auditory outcomes . There was no evidence that acoustically modified speech input enhanced comprehension . CONCLUSIONS Rote training of comprehension of reversible sentences does not seem to be an effective approach to remediating such problems . For most children , the pattern of performance suggested that the problem was not a lack of syntactic knowledge , bur rather limited processing capacity that led to failures of on-line computation of meaning Seventy-seven children between the ages of 6 and 10 years , with severe mixed receptive-expressive specific language impairment ( SLI ) , participated in a r and omized controlled trial ( RCT ) of Fast ForWord ( FFW ; Scientific Learning Corporation , 1997 , 2001 ) . FFW is a computer-based intervention for treating SLI using acoustically enhanced speech stimuli . These stimuli are modified to exaggerate their time and intensity properties as part of an adaptive training process . All children who participated in the RCT maintained their regular speech and language therapy and school regime throughout the trial . St and ardized measures of receptive and expressive language were used to assess performance at baseline and to measure outcome from treatment at 9 weeks and 6 months . Children were allocated to 1 of 3 groups . Group A ( n = 23 ) received the FFW intervention as a home-based therapy for 6 weeks . Group B ( n = 27 ) received commercially available computer-based activities design ed to promote language as a control for computer games exposure . Group C ( n = 27 ) received no additional study intervention . Each group made significant gains in language scores , but there was no additional effect for either computer intervention . Thus , the findings from this RCT do not support the efficacy of FFW as an intervention for children with severe mixed receptive-expressive SLI PURPOSE A r and omized controlled trial was conducted to compare the language and auditory processing outcomes of children assigned to receive the Fast ForWord Language intervention ( FFW-L ) with the outcomes of children assigned to nonspecific or specific language intervention comparison treatments that did not contain modified speech . METHOD Two hundred sixteen children between the ages of 6 and 9 years with language impairments were r and omly assigned to 1 of 4 conditions : ( a ) Fast ForWord Language ( FFW-L ) , ( b ) academic enrichment ( AE ) , ( c ) computer-assisted language intervention ( CALI ) , or ( d ) individualized language intervention ( ILI ) provided by a speech- language pathologist . All children received 1 hr and 40 min of treatment , 5 days per week , for 6 weeks . Language and auditory processing measures were administered to the children by blinded examiners before treatment , immediately after treatment , 3 months after treatment , and 6 months after treatment . RESULTS The children in all 4 conditions improved significantly on a global language test and a test of backward masking . Children with poor backward masking scores who were r and omized to the FFW-L condition did not present greater improvement on the language measures than children with poor backward masking scores who were r and omized to the other 3 conditions . Effect sizes , analyses of st and ard error of measurement , and normalization percentages supported the clinical significance of the improvements on the Comprehensive Assessment of Spoken Language ( E. Carrow-Woolfolk , 1999 ) . There was a treatment effect for the Blending Words subtest of the Comprehensive Test of Phonological Processing ( R. K. Wagner , J. K. Torgesen , & C. A. Rashotte , 1999 ) . Participants in the FFW-L and CALI conditions earned higher phonological awareness scores than children in the ILI and AE conditions at the 6-month follow-up testing . CONCLUSION Fast ForWord Language , the intervention that provided modified speech to address a hypothesized underlying auditory processing deficit , was not more effective at improving general language skills or temporal processing skills than a nonspecific comparison treatment ( AE ) or specific language intervention comparison treatments ( CALI and ILI ) that did not contain modified speech stimuli . These findings call into question the temporal processing hypothesis of language impairment and the hypothesized benefits of using acoustically modified speech to improve language skills . The finding that children in the 3 treatment conditions and the active comparison condition made clinical ly relevant gains on measures of language and temporal auditory processing informs our underst and ing of the variety of intervention activities that can facilitate development Children with language -based learning impairments ( LLIs ) have major deficits in their recognition of some rapidly successive phonetic elements and nonspeech sound stimuli . In the current study , LLI children were engaged in adaptive training exercises mounted as computer “ games ” design ed to drive improvements in their “ temporal processing ” skills . With 8 to 16 hours of training during a 20-day period , LLI children improved markedly in their abilities to recognize brief and fast sequences of nonspeech and speech stimuli
Output:
| RESULTS Meta-analyses indicated that there was no significant effect of Fast ForWord on any outcome measure in comparison to active or untreated control groups .
There is no evidence from the analysis carried out that Fast ForWord is effective as a treatment for children 's oral language or reading difficulties |
MS211627 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To assess the impact of a school-based nutrition education intervention aim ed at increasing the consumption of fruits and vegetables . DESIGN The intervention programme increased the provision of fruits and vegetables in schools and provided a range of point-of-purchase marketing material s , newsletters for children and parents , and teacher information . Curriculum material s at age 6 - 7 and 10 - 11 years were also developed and utilised . Evaluation was undertaken with groups of younger ( aged 6 - 7 years ) and older ( aged 10 - 11 years ) children . Methods included 3-day dietary records with interview and cognitive and attitudinal measures at baseline , with follow-up at 9 months , in intervention and control schools . SETTING The work was undertaken in primary schools in Dundee , Scotl and . SUBJECTS Subjects comprised 511 children in two intervention schools with a further 464 children from two schools acting as controls . RESULTS Children ( n=64 ) in the intervention schools had an average increase in fruit intake ( 133+/-1.9 to 183+/-17.0 g day(-1 ) ) that was significantly ( P<0.05 ) greater than the increase ( 100+/-11.7 to 107+/-14.2 g day(-1 ) ) estimated in children ( n=65 ) in control schools . No other changes in food or nutrient intake were detected . Increases in scores for variables relating to knowledge about fruits and vegetables and subjective norms were also greater in the intervention than in the control group , although taste preferences for fruits and vegetables were unchanged . CONCLUSIONS It is concluded that a whole school approach to increasing intakes of fruits and vegetables has a modest but significant effect on cognitive and attitudinal variables and on fruit intake OBJECTIVE To evaluate the impact of a school-based health behavior intervention known as Planet Health on obesity among boys and girls in grade s 6 to 8 . DESIGN R and omized , controlled field trial with 5 intervention and 5 control schools . Outcomes were assessed using preintervention ( fall 1995 ) and follow-up measures ( spring 1997 ) , including prevalence , incidence , and remission of obesity . PARTICIPANTS A group of 1295 ethnically diverse grade 6 and 7 students from public schools in 4 Massachusetts communities . INTERVENTION Students participated in a school-based interdisciplinary intervention over 2 school years . Planet Health sessions were included within existing curricula using classroom teachers in 4 major subjects and physical education . Sessions focused on decreasing television viewing , decreasing consumption of high-fat foods , increasing fruit and vegetable intake , and increasing moderate and vigorous physical activity . MAIN OUTCOME MEASURES Obesity was defined as a composite indicator based on both a body mass index and a triceps skinfold value greater than or equal to age- and sex-specific 85th percentiles . Because schools were r and omized , rather than students , the generalized estimating equation method was used to adjust for individual-level covariates under cluster r and omization . RESULTS The prevalence of obesity among girls in intervention schools was reduced compared with controls , controlling for baseline obesity ( odds ratio , 0.47 ; 95 % confidence interval , 0.24 - 0.93 ; P = .03 ) , with no differences found among boys . There was greater remission of obesity among intervention girls vs. control girls ( odds ratio , 2.16 ; 95 % confidence interval , 1.07 - 4.35 ; P = .04 ) . The intervention reduced television hours among both girls and boys , and increased fruit and vegetable consumption and result ed in a smaller increment in total energy intake among girls . Reductions in television viewing predicted obesity change and mediated the intervention effect . Among girls , each hour of reduction in television viewing predicted reduced obesity prevalence ( odds ratio , 0.85 ; 95 % confidence interval , 0.75 - 0.97 ; P = .02 ) . CONCLUSION Planet Health decreased obesity among female students , indicating a promising school-based approach to reducing obesity among youth BACKGROUND This study evaluated the effects of a school-based dietary intervention program to increase fruit and vegetable consumption among fourth- grade rs . METHODS Twenty-eight elementary schools were r and omized to an immediate intervention condition or to a delayed intervention control condition . Measures of diet and psychosocial variables were collected at base line and 1 and 2 years post-baseline . The intervention included classroom , parent , and cafeteria components . RESULTS Mean daily consumption of fruit and vegetables was higher for the intervention children compared with controls at Follow-up 1 ( X(t ) = 3.96 , X(c ) = 2.28 ) and at Follow-up 2 ( X(t ) = 3.20 , X(c ) = 2.21 ) . Macro- and micronutrient changes favoring the intervention children were also observed at both Follow-up 1 and Follow-up 2 . Mean daily consumption of fruit and vegetables was higher for intervention parents compared with controls at Follow-up 1 ( X(t ) = 4.23,X(c ) = 3.94 ) but not at Follow-up 2 . CONCLUSIONS Strong effects were found for the High 5 intervention on fruit and vegetable consumption , on macro- and micro-nutrients , and on psychosocial variables . Future work is needed to enhance the intervention effects on parents ' consumption and to test the effectiveness of the intervention when delivered by classroom teachers OBJECTIVE To determine the uptake of a free fruit provision to low-decile primary -school children by quantitatively assessing changes in fruit intake . DESIGN A r and omised controlled trial using a paired , cluster r and omisation . SETTING Twenty low-decile primary schools ( schools attended by the most deprived children ) in Auckl and , New Zeal and . SUBJECTS In total 2032 children , aged 7 - 11 years , provided data on at least one occasion . INTERVENTION Ten pairs of low-decile primary schools matched by roll size and location were r and omly allocated to control ( no free fruit ) or intervention ( free fruit ) for a school term . Dietary assessment s using the 24 h recall methodology were made at baseline , on the last week of the intervention and 6 weeks post-intervention . RESULTS Fruit intakes in this cohort were lower than the national average with over 40 % reporting no fruit intake at baseline and did not differ between groups . After the free fruit period the intervention group increased school fruit intakes by 0.39 pieces/school d from baseline ( P < or = 0.001 ) and the proportion of children consuming no fruit reduced to 22 % . This increase , however , was not sustained and fruit intakes fell below baseline levels at 6 weeks post-intervention . Control subjects did not significantly alter their fruit intakes throughout the study . CONCLUSIONS Improving exposure and accessibility to fruits at school increases fruit intakes of low socio-economic group children , particularly those who do not normally eat fruit . The present pilot study demonstrates some possible negative effects of short-term free fruit interventions , but is informative for developing and evaluating sustained fruit intervention programmes OBJECTIVE Children 's fruit/vegetable intake is still below recommended levels . This study applied Internet-tailored advice for schoolchildren and Internet-supported brief dietary counselling ( with child and parent ) within preventive health care to promote fruit/vegetable intake . SETTING /SUBJECTS The study involved 30 seventh- grade classes ( 16 in the intervention group and 14 in the control group ) with a total of 675 children aged 9 - 12 years , of whom 495 were allowed to participate . DESIGN A cluster-r and omised baseline-post-test experimental design was applied . During school hours , all children completed Internet-administered question naires on fruit/vegetable intake and related determinants . Children in the intervention group received immediate online individually tailored nutrition feedback . For each child in the intervention group , a nurse received information concerning the assessment of fruit/vegetable intake via the Internet to support a 5 min counselling protocol to promote fruit/vegetable intake . Children completed a similar post-test question naire 3 months after the first assessment . Intention-to-treat analyses were conducted using multilevel regression analyses . RESULTS A total of 486 children ( 98 % of 495 ) participated ( 263 in the intervention group , 223 in the control group ) ; 240 child-parent couples in the intervention group attended the counselling . Awareness of inadequate fruit intake ( odds ratio ( OR ) = 3.0 ; 95 % confidence interval ( CI ) = 1.8 - 5.3 ) and knowledge of recommended vegetable intake levels ( OR = 2.7 ; 95 % CI = 1.8 - 4.1 ) were significantly more likely at post-test in the intervention group than in the control group . No significant effects were found on intake or other determinants . CONCLUSIONS A compact , integrated two-component intervention can induce positive changes in knowledge and awareness of intake levels of fruit/vegetables among schoolchildren . To induce changes in intake levels , more comprehensive interventions may be needed This study describes the development and usage of a Web-based component of a nutrition and physical activity behavioral intervention to promote bone health among preadolescent girls . Thirty Girl Scout troops were r and omized to either an intervention or control group for a 2-year period . Girls in the intervention troops ( aged 10 to 12 years , N=194 ) were exposed to grade -specific Web sites that were developed to reinforce the content of the broader , face-to-face intervention . In 5th grade , 82 % of the girls logged on once and 48 % logged on more than once , compared to 56 % and 23 % of 6th grade rs , respectively . Results suggest that although Web-site usage decreased over time , a Web-site program may be useful as a component of a face-to-face , multicomponent intervention . More research is needed to determine ways to enhance and maintain Web-site use over time among youth in health-behavior intervention programs OBJECTIVE The Girls health Enrichment Multisite Studies ( GEMS ) Fun , Food , and Fitness Project ( FFFP ) was design ed to prevent obesity among 8-year-old African-American girls . DESIGN Twelve-week , two-arm parallel group r and omized controlled pilot study . SETTING Summer day camp and homes in Houston , Texas . PARTICIPANTS Thirty-five girls and their parents or caregivers were r and omly assigned to treatment ( N=19 ) or control groups ( N=16 ) . INTERVENTION Girls in the intervention group attended a special 4-week summer day camp , followed by a special 8-week home Internet intervention for the girls and their parents . Control group girls attended a different 4-week summer day camp , followed by a monthly home Internet intervention , neither of which components included the GEMS-FFFP enhancements . MAIN OUTCOME MEASURES Body mass index ( BMI ) , consumption of fruit , 100 % fruit juice , and vegetables ( FJV ) , physical activity . RESULTS After adjusting for baseline BMI , there were no significant differences in BMI between treatment and control group girls , either at the end of the 4-week summer day camp , or after the full 12-week intervention . By the end of the summer camp , the subgroup of treatment group girls heavier at baseline exhibited a trend ( P<.08 ) toward lower BMI , compared to their heavier counterparts in the control group . Overall results at the end of the 12-week program demonstrated substantial , although not significant , differences between treatment and control groups in the hypothesized directions . On average , less than half the treatment sample logged onto the Website , which limited intervention dose . CONCLUSIONS Summer day camp appears to offer promise for initiating health behavior change . Effective methods must be developed and tested to enhance log-on rates among healthy children and their parents before Internet programs can achieve their potential The goal was to have children and adolescents identify and rank the major perceived benefits of and barriers to healthful eating and physical activity and to suggest strategies for overcoming barriers . Semistructured , in-depth focus groups were undertaken using st and ardized questions and prompts . Students in grade s 2 through 11(ages 7 through 17 ; N=213 ) from 34 r and omly selected schools participated in 38 focus groups . Major benefits of healthful eating included improvements to cognitive and physical performance , fitness , endurance , psychological benefits , physical sensation ( feeling good physically ) , and production of energy . Barriers included convenience , taste , and social factors . Benefits of physical activity included social benefits , enhancement of psychological status , physical sensation , and sports performance . Barriers included a preference for indoor activities , lack of energy and motivation , time constraints , and social factors . Suggested strategies for overcoming barriers included support from parents and school staff , better planning , time management , self-motivation , education , restructuring the physical environment , and greater variety of physical activities PURPOSE To test the effects of a classroom and World Wide Web ( WWW ) educational intervention on self-efficacy ( SE ) for healthy eating ( HE ) and to examine the relationship of the theoretical concepts in a hypothesized model of eating behavior in adolescents . DESIGN A quasiexperimental pretest , posttest design was used in a r and om sample of students in two junior high schools . METHODS The intervention consisted of a combination of 5 hours of Web-based instruction and 10 hours of classroom curriculum , compared to nutrition education embedded in the st and ard school curriculum during a 1-month period . Participants completed six question naires . Data were analyzed using descriptive statistics , t tests , and Pearson 's r correlation coefficient . FINDINGS AND CONCLUSIONS The intervention group had significantly higher scores for SE for fruits and vegetables , SE for lower fat , usual food choices , and dietary knowledge of fat compared to the control group . No difference was found between groups in food consumption . Self-efficacy was significantly associated with
Output:
| Most of these programs were effective in achieving the objectives established .
Some of the main advantages the Internet provides are : the opportunity to put the children in contact with education and health professionals ; children can keep a record of the food consumed ; and it is a more attractive and interesting way for children to learn NE , compared to traditional methods |
MS211628 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Estimation of glomerular filtration rate ( GFR ) is limited by differences in creatinine generation among ethnicities . Our previously reported GFR-estimating equations for Japanese had limitations because all participants had a GFR less than 90 mL/min/1.73 m2 and serum creatinine was assayed in different laboratories . STUDY DESIGN Diagnostic test study using a prospect i ve cross-sectional design . New equations were developed in 413 participants and vali date d in 350 participants . All sample s were assayed in a central laboratory . SETTING & PARTICIPANTS Hospitalized Japanese patients in 80 medical centers . Patients had not participated in the previous study . REFERENCE TEST Measured GFR ( mGFR ) computed from inulin clearance . INDEX TEST Estimated GFR ( eGFR ) by using the modified isotope dilution mass spectrometry (IDMS)-traceable 4-variable Modification of Diet in Renal Disease ( MDRD ) Study equation using the previous Japanese Society of Nephrology Chronic Kidney Disease Initiative ( JSN-CKDI ) coefficient of 0.741 ( equation 1 ) , the previous JSN-CKDI equation ( equation 2 ) , and new equations derived in the development data set : modified MDRD Study using a new Japanese coefficient ( equation 3 ) , and a 3-variable Japanese equation ( equation 4 ) . MEASUREMENTS Performance of equations was assessed by means of bias ( eGFR - mGFR ) , accuracy ( percentage of estimates within 15 % or 30 % of mGFR ) , root mean squared error , and correlation coefficient . RESULTS In the development data set , the new Japanese coefficient was 0.808 ( 95 % confidence interval , 0.728 to 0.829 ) for the IDMS-MDRD Study equation ( equation 3 ) , and the 3-variable Japanese equation ( equation 4 ) was eGFR ( mL/min/1.73 m2 ) = 194 x Serum creatinine(-1.094 ) x Age(-0.287 ) x 0.739 ( if female ) . In the validation data set , bias was -1.3 + /- 19.4 versus -5.9 + /- 19.0 mL/min/1.73 m2 ( P = 0.002 ) , and accuracy within 30 % of mGFR was 73 % versus 72 % ( P = 0.6 ) for equation 3 versus equation 1 and -2.1 + /- 19.0 versus -7.9 + /- 18.7 mL/min/1.73 m(2 ) ( P < 0.001 ) and 75 % versus 73 % ( P = 0.06 ) for equation 4 versus equation 2 ( P = 0.06 ) , respectively . LIMITATION Most study participants had chronic kidney disease , and some may have had changing GFRs . CONCLUSION The new Japanese coefficient for the modified IDMS-MDRD Study equation and the new Japanese equation are more accurate for the Japanese population than the previously reported equations The glomerular filtration rate ( GFR ) is traditionally considered the best overall index of renal function in health and disease ( 1 ) . Because GFR is difficult to measure in clinical practice , most clinicians estimate the GFR from the serum creatinine concentration . However , the accuracy of this estimate is limited because the serum creatinine concentration is affected by factors other than creatinine filtration ( 2 , 3 ) . To circumvent these limitations , several formulas have been developed to estimate creatinine clearance from serum creatinine concentration , age , sex , and body size ( 4 - 12 ) . Despite more recent studies that have related serum creatinine concentration to GFR ( 13 - 24 ) , no formula is more widely used to predict creatinine clearance than that proposed by Cockcroft and Gault ( 4 ) . This formula is used to detect the onset of renal insufficiency , to adjust the dose of drugs excreted by the kidney , and to evaluate the effectiveness of therapy for progressive renal disease . More recently , it has been used to document eligibility for reimbursement from the Medicare End Stage Renal Disease Program ( 25 ) and for accrual of points for patients on the waiting list for cadaveric renal transplantation ( 26 ) . Major clinical decisions in general medicine , geriatrics , and oncology ( as well as nephrology ) are made by using the Cockcroft-Gault formula and other formulas to predict the level of renal function . Therefore , these formulas must predict GFR as accurately as possible . The Modification of Diet in Renal Disease ( MDRD ) Study , a multicenter , controlled trial , evaluated the effect of dietary protein restriction and strict blood pressure control on the progression of renal disease ( 27 - 30 ) . During the baseline period , GFR , serum creatinine , and several variables that affect the relation between them were measured in patients with chronic renal disease . The purpose of our study was to develop an equation from MDRD Study data that could improve the prediction of GFR from serum creatinine concentration . Methods Baseline Cohort and Measurement Methods in the Modification of Diet in Renal Disease Study The overall study design and methods of recruitment for the MDRD Study have been described elsewhere ( 31 , 32 ) . A total of 1785 patients entered the baseline period . Of these patients , 1628 ( 91 % ) also underwent measurement of GFR and the other variables described below ; these patients constitute the study group for these analyses . Glomerular filtration rate was measured as the renal clearance of 125I-iothalamate ( 33 , 34 ) . Creatinine clearance was computed from creatinine excretion in a 24-hour urine collection and a single measurement of serum creatinine . Serum and urine creatinine were measured by using a kinetic alkaline picrate assay with a normal range in serum of 62 to 124 mol/L ( 0.7 to 1.4 mg/dL ) ( 35 ) . Glomerular filtration rate and creatinine clearance were expressed per 1.73 m2 of body surface area by multiplying measured values by 1.73/body surface area ( 36 ) . The serum and urine specimens were also used for other measurements , including serum albumin ( bromcresol green method [ 35 ] ) , serum urea nitrogen ( urease method [ 35 ] ) , and urine urea nitrogen ( urease method [ 35 ] ) . Protein intake ( g/d ) was estimated as 6.25 [ UUN ( g/d ) + 0.031 ( g/kg per day ) SBW ( kg ) ] , where UUN is urine urea nitrogen , SBW is st and ard body weight , and 0.031 g/kg per day is a constant reflecting the rate of excretion of nitrogen in compounds other than urine urea ( 37 , 38 ) . The diagnosis of diabetes and the cause of renal disease were assigned on the basis of chart review at the clinical center ( 39 ) . Statistical Analysis Descriptive Statistics The relation of renal function measurements to other baseline characteristics was assessed by using contingency tables , t-tests , analysis of variance , and linear regression , as appropriate . Nonparametric tests ( Wilcoxon rank-sum tests and Kruskal-Wallis tests ) gave consistent results . A P value less than 0.01 was considered statistically significant . Multivariable Analysis of Glomerular Filtration Rate We used stepwise multiple regression to determine a set of variables that jointly predicted GFR . The stepwise regression models were developed by using a training sample consisting of a r and om sample of 1070 of the 1628 patients . We found that the variability of the difference between the observed and predicted GFR values was greater for higher GFR values . This increase was eliminated by performing multiple regressions on log-transformed data . To facilitate clinical interpretation , the results were re-expressed in terms of the original units . Consequently , the prediction equation is a multiplicative model ; regression coefficients refer to the change in geometric mean GFR associated with unit changes in the independent variable . Predicted GFR is expressed in mL/min per 1.73 m2 . The following variables were considered for possible inclusion in the regression model : weight , height , sex , ethnicity , age , diagnosis of diabetes , serum creatinine concentration , serum urea nitrogen level , serum albumin level , serum phosphorus level , serum calcium level , mean arterial pressure , urine creatinine level , urine urea nitrogen level , urine protein level , and urine phosphorus level . The cause of renal disease was not included because in clinical practice , the cause may be unknown or clinicians may not use the same classification method as the investigators in the MDRD Study . A P value less than 0.001 was used as the criterion for entry of a variable into the model . Because of the difficulty in collecting complete 24-hour urine sample s in clinical practice , an additional stepwise regression was performed to develop a prediction model that did not include urine biochemistry variables . Finally , because of the interest in developing a prediction equation to assess eligibility for Medicare reimbursement and listing for cadaveric renal transplantation , we repeated the analysis restricting the population to the subgroup of patients with higher serum creatinine concentrations ( > 221 mol/L [ 2.5 mg/dL ] ; n=509 in the training sample ) . Methods for Comparing Equations To Predict Glomerular Filtration Rate We first developed coefficients for each prediction equation ( including the selection of the predictor variables for the stepwise regressions ) using the data from the training sample to predict log GFR . Each prediction equation also included a multiplicative constant to account for any consistent bias in the application of that equation in the MDRD Study Group . This was particularly important for equations that are intended to estimate creatinine clearance , which is known to be higher than GFR . The regression coefficients determined in the training sample were then applied to obtain predicted GFRs in a separate validation sample consisting of the remaining 558 patients ( 172 patients with serum creatinine concentration>221 mol/L [ 2.5 mg/dL ] ) . These predicted GFR values were compared with the actual GFRs in the validation sample to evaluate the performance of each prediction equation . In this way , separate data sets were used to construct the equations and assess their accuracy after removal of systematic bias . For each equation , we computed overall R 2 ( percentage of variability in log GFR explained by the regression model ) and the 50th , 75th , and 90th percentiles of the distribution of the percentage absolute difference between measured and predicted GFRs in the validation sample . The 50th percentiles indicate the typical size of the errors in prediction of GFR , and the 75th and 90th percentiles assess the sizes of the larger errors that occurred for each model . Development of Final Prediction Equations To improve the accuracy of the final MDRD Study prediction equations , the regression coefficients derived from the training sample were up date d on the basis of data from all 1628 patients . As a result , the st and ard errors of the regression coefficients in the final MDRD Study prediction equations are slightly smaller than those derived from the training sample ; thus , the accuracy of the final prediction equations may be slightly better ( by about 0.1 % to 0.2 % ) than their accuracy as assessed in the validation sample . Results Demographic and Clinical Characteristics The mean age ( SD ) of the cohort was 50.6 12.7 years . Sixty percent of patients were male , 88 % were white , and 6 % were diabetic . Causes of renal disease were glomerular disease ( 32 % ) , polycystic kidney disease ( 22 % ) , tubulointerstitial disease ( 7 % ) , and other or unknown renal diseases ( 40 % ) . Mean protein intake was 0.99 0.24 g/kg of body weight per day and mean arterial pressure was 99.4 12.2 mm Hg . Mean weight was 79.6 16.8 kg , body surface area was 1.91 0.23 m2 , serum urea nitrogen concentration was 11.4 5.7 mmol/L [ 32 16 mg/dL ] , and serum albumin concentration was 40.0 4.0 g/L [ 4.0 0.4 g/dL ] , respectively . Glomerular Filtration Rate , Creatinine Clearance , and Serum Creatinine Concentration Renal function measurements for the study group and for various subgroups are shown in Table 1 . Mean GFR for the population was 0.38 mL s 2 m 2 ( 39.8 mL/min per 1.73 m2 ) , with lower values in patients with lower protein intake , white patients compared with black patients , and older patients ( 55 years ) compared with younger patients ( P<0.01 ) . The mean value of creatinine clearance was 0.81 mL s 2 m 2 ( 48.6 mL/min per 1.73 m2 ) and was lower in older patients and patients with lower protein intake ( P 0.01 ) . The mean serum creatinine concentration was 203 mol/L ( 2.3 mg/dL ) and was higher in men , patients with lower protein intake , and patients with higher mean arterial pressure ( P 0.01 ) . Figure 1 shows the well-known reciprocal relation of serum creatinine concentration to GFR for subgroups based on sex and ethnicity . At any given GFR , the serum creatinine concentration is significantly higher in men than in women and in black persons than in white persons ( P<0.001 ) . Table 1 . Association of Renal BACKGROUND AND OBJECTIVES The Modification of Diet in Renal Disease ( MDRD ) study equation and the Cockcroft-Gault ( CG ) equation perform poorly in the ( near- ) normal range of GFR . Whether this is due to the level of GFR as such or to differences in individual characteristics between healthy individuals and patient with chronic kidney disease (
Output:
| Neither the CKD-EPI nor the MDRD Study equation is optimal for all population s and GFR ranges . |
MS211629 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: This study examined outcomes associated with the Family Check-Up ( FCU ) , an adaptive , tailored , family-centered intervention to enhance positive adjustment of middle school youth and prevent problem behavior . The FCU intervention model was delivered to families in 3 public middle schools . The study sample comprised 377 families , and participants were r and omly assigned to receive either the intervention or school as usual . Participation in the intervention was relatively high , with 38 % of the families receiving the FCU . Participation in the intervention improved youth self-regulation over the 3 years of the study . Self-regulation skills , defined as effortful control , predicted both decreased depression and increased school engagement in high school , with small to medium effect sizes . The results have implication s for the delivery of mental health services in schools that specifically target family involvement and parenting skills Research Findings : Parental engagement with children has been linked to a number of adaptive characteristics in preschool children , and relationships between families and professionals are an important contributor to school readiness . Furthermore , social – emotional competence is a key component of young children 's school readiness . This study reports the results of a r and omized trial of a parent engagement intervention ( Getting Ready ) design ed to facilitate school readiness among disadvantaged preschool children , with a particular focus on social – emotional outcomes . Two hundred and twenty children were involved over the 4-year study period . Statistically significant differences were observed between treatment and control participants in the rate of change over a 2-year period on teacher reports for certain interpersonal competencies ( i.e. , attachment , initiative , and anxiety/withdrawal ) . In contrast , no statistically significant differences between groups over a 2-year period were noted for behavioral concerns ( anger/aggression , self-control , or behavioral problems ) as a function of the Getting Ready intervention . Practice or Policy : The intervention appears to be particularly effective at building social – emotional competencies beyond the effects experienced as a function of participation in Head Start programming alone . Limitations and implication s for future research are review ed Self-regulatory abilities are robust predictors of important outcomes across the life span , yet they are rarely taught explicitly in school . Using a r and omized controlled design , the present study investigated the effects of a 12-week mindfulness-based Kindness Curriculum ( KC ) delivered in a public school setting on executive function , self-regulation , and prosocial behavior in a sample of 68 preschool children . The KC intervention group showed greater improvements in social competence and earned higher report card grade s in domains of learning , health , and social-emotional development , whereas the control group exhibited more selfish behavior over time . Interpretation of effect sizes overall indicate small to medium effects favoring the KC group on measures of cognitive flexibility and delay of gratification . Baseline functioning was found to moderate treatment effects with KC children initially lower in social competence and executive functioning demonstrating larger gains in social competence relative to the control group . These findings , observed over a relatively short intervention period , support the promise of this program for promoting self-regulation and prosocial behavior in young children . They also support the need for future investigation of program implementation across diverse setting Youth in underserved , urban communities are at risk for a range of negative outcomes related to stress , including social-emotional difficulties , behavior problems , and poor academic performance . Mindfulness-based approaches may improve adjustment among chronically stressed and disadvantaged youth by enhancing self-regulatory capacities . This paper reports findings from a pilot r and omized controlled trial assessing the feasibility , acceptability , and preliminary outcomes of a school-based mindfulness and yoga intervention . Four urban public schools were r and omized to an intervention or wait-list control condition ( n = 97 fourth and fifth grade rs , 60.8 % female ) . It was hypothesized that the 12-week intervention would reduce involuntary stress responses and improve mental health outcomes and social adjustment . Stress responses , depressive symptoms , and peer relations were assessed at baseline and post-intervention . Findings suggest the intervention was attractive to students , teachers , and school administrators and that it had a positive impact on problematic responses to stress including rumination , intrusive thoughts , and emotional arousal Based on theoretically driven models , the Chicago School Readiness Project ( CSRP ) targeted low-income children 's school readiness through the mediating mechanism of self-regulation . The CSRP is a multicomponent , cluster-r and omized efficacy trial implemented in 35 Head Start-funded classrooms ( N = 602 children ) . The analyses confirm that the CSRP improved low-income children 's self-regulation skills ( as indexed by attention/impulse control and executive function ) from fall to spring of the Head Start year . Analyses also suggest significant benefits of CSRP for children 's preacademic skills , as measured by vocabulary , letter-naming , and math skills . Partial support was found for improvement in children 's self-regulation as a hypothesized mediator for children 's gains in academic readiness . Implication s for programs and policies that support young children 's behavioral health and academic success are discussed Background Growing evidence suggests that childhood and adolescence self-regulation contributes to multiple health , educational and social outcomes . Considering the potential impact of self-regulation skills on improved life chances in conjunction with evidence suggesting that self-regulation can be modified by interventions , there is a need to identify interventions which are most effective in improving childhood and adolescence self-regulation . The present systematic review was design ed to determine the effectiveness of universal interventions focused on enhancing the self-regulation of children and adolescents . As secondary outcomes , we will also examine the effectiveness of such interventions on distal health and social outcomes . Methods Eligible studies include r and omised controlled trials ( including cluster r and omised trials ) reporting on universal interventions design ed to improve self-regulation in childhood and adolescence ( age 0–19 years ) . The following data bases will be search ed for peer- review ed publications using an iterative search strategy : Medline , PsycINFO , EMBASE , ERIC , CINAHL Plus , British Education Index , Child Development & Adolescent Studies and CENTRAL without applying language or date filters . Additionally , reference lists and citations of included studies will be search ed for eligible studies . A 10 % proportion of the total titles and abstract s will be r and omly selected and screened independently by two review ers ( AP and DH ) . Results will be compared to ensure less than 5 % discrepancy , followed by screening of all results by one review er ( AP ) . Full-text review and data collection will be independently performed by two review ers . Any discrepancies will be solved by mutual discussion , and if unresolved , a third review er ( RV ) will be consulted . Meta- analysis will be conducted to quantify trial effects , if the data is sufficiently homogenous to allow quantitative synthesis . Otherwise , results will be described narratively . Discussion The evidence derived from the systematic review will strengthen the evidence base to inform planning of effective interventions targeting self-regulation skills in childhood and adolescence . This will benefit policy makers , academicians , research ers , health professionals , and also , young people who will benefit from policy and interventions informed by this review . Systematic review registration CRD42016047661 Adolescence is a key developmental period for preventing substance use initiation , however prevention programs solely providing educational information about the dangers of substance use rarely change adolescent substance use behaviors . Recent research suggests that mind – body practice s such as yoga may have beneficial effects on several substance use risk factors , and that these practice s may serve as promising interventions for preventing adolescent substance use . The primary aim of the present study was to test the efficacy of yoga for reducing substance use risk factors during early adolescence . Seventh- grade students in a public school were r and omly assigned by classroom to receive either a 32-session yoga intervention ( n = 117 ) in place of their regular physical education classes or to continue with physical-education-as-usual ( n = 94 ) . Participants ( 63.2 % female ; 53.6 % White ) completed pre- and post-intervention question naires assessing emotional self-regulation , perceived stress , mood impairment , impulsivity , substance use willingness , and actual substance use . Participants also completed question naires at 6-months and 1-year post-intervention . Results revealed that participants in the control condition were significantly more willing to try smoking cigarettes immediately post-intervention than participants in the yoga condition . Immediate pre- to post-intervention differences did not emerge for the remaining outcomes . However , long-term follow-up analyses revealed a pattern of delayed effects in which females in the yoga condition , and males in the control condition , demonstrated improvements in emotional self-control . The findings suggest that school-based yoga may have beneficial effects with regard to preventing males ’ and females ’ willingness to smoke cigarettes , as well as improving emotional self-control in females . However additional research is required , particularly with regard to the potential long-term effects of mind – body interventions in school setting s. The present study contributes to the literature on adolescence by examining school-based yoga as a novel prevention program for substance use risk factors Effective early education is essential for academic achievement and positive life outcomes , particularly for children in poverty . Advances in neuroscience suggest that a focus on self-regulation in education can enhance children ’s engagement in learning and establish beneficial academic trajectories in the early elementary grade s. Here , we experimentally evaluate an innovative approach to the education of children in kindergarten that embeds support for self-regulation , particularly executive functions , into literacy , mathematics , and science learning activities . Results from a cluster r and omized controlled trial involving 29 schools , 79 classrooms , and 759 children indicated positive effects on executive functions , reasoning ability , the control of attention , and levels of salivary cortisol and alpha amylase . Results also demonstrated improvements in reading , vocabulary , and mathematics at the end of kindergarten that increased into the first grade . A number of effects were specific to high-poverty schools , suggesting that a focus on executive functions and associated aspects of self-regulation in early elementary education holds promise for closing the achievement gap PURPOSE A growing body of research documents the significance of siblings and sibling relationships for development , mental health , and behavioral risk across childhood and adolescence . Nonetheless , few well- design ed efforts have been undertaken to promote positive and reduce negative youth outcomes by enhancing sibling relationships . METHODS Based on a theoretical model of sibling influences , we conducted a r and omized trial of Siblings Are Special ( SIBS ) , a group-format afterschool program for fifth grade rs with a younger sibling in second through fourth grade s , which entailed 12 weekly afterschool sessions and three Family Nights . We tested program efficacy with a pre- and post-test design with 174 families r and omly assigned to condition . In home visits at both time points , we collected data via parent question naires , child interviews , and observer-rated videotaped interactions and teachers rated children 's behavior at school . RESULTS The program enhanced positive sibling relationships , appropriate strategies for parenting siblings , and child self-control , social competence , and academic performance ; program exposure was also associated with reduced maternal depression and child internalizing problems . Results were robust across the sample , not qualified by sibling gender , age , family demographics , or baseline risk . No effects were found for sibling conflict , collusion , or child externalizing problems ; we will examine follow-up data to determine if short-term impacts lead to reduced negative behaviors over time . CONCLUSIONS The breadth of the SIBS program 's impact is consistent with research suggesting that siblings are an important influence on development and adjustment and supports our argument that a sibling focus should be incorporated into youth and family-oriented prevention programs Children need to be equipped with the skills to respond effectively to stress and prevent poor decision-making surrounding alcohol and tobacco use . Training and practice in mindfulness is one possible avenue for building children 's skills . Recent research has revealed that mindfulness education in the classroom may play a role in enhancing children 's self-regulatory abilities . Thus , the goal of the current study was to extend existing research in mindfulness education in classrooms and conduct an assessment of the feasibility and effectiveness of a new mindfulness education , substance abuse prevention program for fourth- and fifth- grade children ( Master Mind ) . Two elementary schools were r and omly assigned to be an intervention group ( n = 71 ) or wait-list control group ( n = 40 ) . Students in the intervention group were taught the four-week Master Mind program by their regular classroom teachers . At pre- and postintervention time points , students completed self-reports of their intentions to use substances and an executive functioning performance task . Teachers rated students on their behavior in the classroom . Findings revealed that students who participated in the Master Mind program , as compared to those in the wait-list control condition , showed significant improvements in executive functioning skills ( girls and boys ) , as well as a marginally significant increase in self-control abilities ( boys only ) . In addition , significant reductions were found in aggression and social problems ( girls and boys ) , as well as anxiety ( girls only ) . No significant differences across groups were found for intentions to use alcohol or tobacco . Teachers implemented the program with fidelity ; both teachers and students positively rated the structure and content of the Master Mind program , providing evidence of program satisfaction and feasibility . Although generalization may be limited by the small sample size , the findings suggest that mindfulness education may be beneficial in increasing self-regulatory abilities , which is important for substance abuse prevention OBJECTIVE : To assess the effect of a physical activity ( PA ) intervention on brain and behavioral indices of executive control in preadolescent children . METHODS : Two hundred twenty-one children ( 7–9 years ) were r and omly assigned to a 9-month afterschool PA program or a wait-list control . In addition to changes in fitness ( maximal oxygen consumption ) , electrical activity in the brain ( P3-ERP ) and behavioral measures ( accuracy , reaction time ) of executive control were collected by using tasks that modulated attentional inhibition and cognitive flexibility . RESULTS : Fitness improved more among intervention participants from pretest to posttest compared with the wait-list control ( 1.3 mL
Output:
| Conclusions and Relevance A wide range of interventions were successful in improving self-regulation in children and adolescents .
There was improvement in distal academic , health , and behavioral outcomes in most intervention groups compared with controls |
MS211630 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background : Psychiatric advance directives are intended to enable self-determined treatment for patients who lose decisional capacity , and thus reduce the need for coercive interventions such as police transport , involuntary commitment , seclusion and restraints , and involuntary medications during mental health crises ; whether PADs can help prevent the use of these interventions in practice is unknown . Aims : This study examined whether completion of a Facilitated Psychiatric Advance Directive ( F-PAD ) was associated with reduced frequency of coercive crisis interventions . Method : The study prospect ively compared a sample of PAD completers ( n = 147 ) to non-completers ( n = 92 ) on the frequency of any coercive interventions , with follow-up assessment s at 6 , 12 , and 24 months . Repeated- measures multiple regression analysis was used to estimate the effect of PADs . Models controlled for relevant covariates including a propensity score for initial selection to PADs , baseline history of coercive interventions , concurrent global functioning and crisis episodes with decisional incapacity . Results : F-PAD completion was associated with lower odds of coercive interventions ( adjusted OR = 0.50 ; 95 % CI = 0.26–0.96 ; p < 0.05 ) . Conclusions : PADs may be an effective tool for reducing coercive interventions around incapacitating mental health crises . Less coercion should lead to greater autonomy and self-determination for people with severe mental illness Background Crises and ( involuntary ) admissions have a strong impact on patients and their caregivers . In some countries , including the Netherl and s , the number of crises and ( involuntary ) admissions have increased in the last years . There is also a lack of effective interventions to prevent their occurrence . Previous research has shown that a form of psychiatric advance statement – joint crisis plan – may prevent involuntary admissions , but another study showed no significant results for another form . The question remains which form of psychiatric advance statement may help to prevent crisis situations . This study examines the effects of two other psychiatric advance statements . The first is created by the patient with help from a patient 's advocate ( Patient Advocate Crisis Plan : PACP ) and the second with the help of a clinician only ( Clinician facilitated Crisis Plan : CCP ) . We investigate whether patients with a PACP or CCP show fewer emergency visits and ( involuntary ) admissions as compared to patients without a psychiatric advance statement . Furthermore , this study seeks to identify possible mechanisms responsible for the effects of a PACP or a CCP . Methods / Design This study is a r and omised controlled trial with two intervention groups and one control condition . Both interventions consist of a crisis plan , facilitated through the patient 's advocate or the clinician respectively . Out patients with psychotic or bipolar disorders , who experienced at least one psychiatric crisis during the previous two years , are r and omly allocated to one of the three groups . Primary outcomes are the number of emergency ( after hour ) visits , ( involuntary ) admissions and the length of stay in hospital . Secondary outcomes include psychosocial functioning and treatment satisfaction . The possible mediator variables of the effects of the crisis plans are investigated by assessing the patient 's involvement in the creation of the crisis plan , working alliance , insight into illness , recovery style , social support , locus of control , service engagement and coping with crises situations . The interviews take place before r and omisation , nine month later and finally eighteen months after r and omisation . Discussion This study examines the effects of two types of crisis plans . In addition , the results offer an underst and ing of the way these advance statements work and whether it is more effective to include a patients ' advocate in the process of creating a psychiatric advance statement . These statements may be an intervention to prevent crises and the use of compulsion in mental health care . The strength and limitations of this study are discussed . Trial registration Current Controlled Trails NTR1166 OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate BACKGROUND An advance directive is a statement of a person 's preferences for treatment , should he or she lose capacity to make treatment decisions in the future . AIMS To evaluate whether use of advance directives by patients with mental illness leads to lower rates of compulsory readmission to hospital . METHOD In a r and omised controlled trial in two psychiatric services in inner London , 156 in- patients about to be discharged from compulsory treatment under the Mental Health Act were recruited . The trial compared usual psychiatric care with usual care plus the completion of an advance directive . The primary outcome was the rate of compulsory readmission . RESULTS Fifteen patients ( 19 % ) in the intervention group and 16 ( 21 % ) in the control group were readmitted compulsorily within 1 year of discharge . There was no difference in the numbers of compulsory readmissions , numbers of patients readmitted voluntarily , days spent in hospital or satisfaction with psychiatric services . CONCLUSIONS Users ' advance instruction directives had little observable impact on the outcome of care at 12 months BACKGROUND Patients and doctors often have divergent views on care needs . AIMS To examine whether providing patients with an opportunity to identify and discuss their needs would improve communication and induce changes in care . METHOD Patients with schizophrenia ( n=134 ) were r and omly allocated to either st and ard care or use of the Two-Way Communication Checklist ( 2-COM ) . Before seeing their clinician for a routine follow-up , participants in the active intervention group were given 2-COM , a list of 20 common needs , and told to indicate those areas they wanted to discuss with their doctor . Outcomes were assessed immediately and again after 6 weeks . RESULTS Using 2-COM induced a stable improvement of patient-reported quality of patient-doctor communication ( B=0.33 , P=0.031 ) , and induced changes in management immediately after the intervention ( OR=3.7 , P=0.009 ; number needed to treat , 6 ) . Treatment change was more likely in patients with more reported needs , and needs most likely to induce treatment change displayed stronger associations with non-medication than with medication changes . CONCLUSIONS A simple intervention to aid people in discussion of their needs results in improved communication and changes in management Summary Advance directive legislation has been in place throughout much of the United States for nearly 3 decades . The right to give an informed consent to or refusal of medical treatment has been recognized by state and federal courts , and that right has been determined to survive the loss of decisional capacity and may be exercised through the execution of instructional or proxy directives . Despite these developments . the percentage of the adult population with a formal advance directive of any type has never exceeded 15 % . Moreover , a remarkable number of these directives are ambiguous and /or their existence is unknown to the physicians who are expected to rely upon them . Even unambiguous directives may not be followed at the critical stage in the trajectory of a patient ’s illness , and the accountability for such disregard by health care institutions or professionals is negligible to nonexistent . Nevertheless , there is real potential for advance directives , as a key element to sound advance care planning , to fulfill their initial promise as instruments of the prospect i ve autonomy of patients . In order for that potential to be realized , primary care physicians must embrace advance care planning as a part of their professional responsibility to patients BACKGROUND Since 1991 , hospitals have asked patients whether they have advance directives , but few patients complete these documents . We assessed two simple interventions to improve completion of advance directives among elderly or chronically ill out patients . METHODS We conducted a cluster r and omized controlled trial involving 1079 patients from five general medicine clinics that were affiliated with an academic medical center . Patients were either > or = 70 years of age or > or = 50 years old with a chronic illness . The study comprised three arms : physician reminders recommending documentation of advance directives , physician reminders plus mailing advance directives to patients together with educational literature , or neither intervention ( control ) . The main outcome measure was completion of an advance directive . RESULTS After 28 weeks , 1.5 % ( 5/332 ) of patients in the physician reminder group , 14 % ( 38/277 ) in the physician reminder plus patient mailing group , and 1.8 % ( 5/286 ) in the control group had completed advance directives . In multivariate analyses , patients in the physician reminder plus patient mailing group were much more likely than controls to have completed advance directives ( odds ratio [ OR ] = 5.9 ; 95 % confidence interval [ CI ] : 1.5 to 22 ) , whereas patients in the physician reminder-only group were no more likely than controls to have completed advance directives ( OR = 0.88 ; 95 % CI : 0.21 to 3.7 ) . CONCLUSION Mailing health care proxy and living will forms and literature to patients before an appointment at which their physicians received a reminder about advance directives yielded a small but significant improvement in completion of these documents . A physician reminder alone did not have an effect Objective Psychiatric advance directives ( PADs ) allow individuals to plan for future mental health treatment . However , little is known about barriers to PAD completion . This paper examines an intervention ’s effect in reducing barriers to PAD completion . Method Patients were r and omly assigned to a facilitated PAD session or control group . Barriers associated with ( 1 ) the PAD documents and ( 2 ) external support for PADs were assessed at baseline ( n = 462 ) , 6 months ( n = 380 ) and 1 year ( n = 362 ) . Results There were no significant baseline between-group differences on the two barriers . However , at follow-up both barriers were significantly lower in the experimental group . Further , barriers were predictive of PAD completion . Conclusions Structured facilitation can significantly reduce barriers to PAD completion . However , the intervention did not eliminate barriers . Findings are discussed in the context of possible system-level changes to further reduce barriers to PAD completion The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas Abstract Objective To investigate whether a form of advance agreement for people with severe mental illness can reduce the use of inpatient services and compulsory admission or treatment . Design Single blind r and omised controlled trial , with r and omisation of individual patients . The investigator was blind to allocation . Setting Eight community mental health teams in southern Engl and . Participants 160 people with an operational diagnosis of psychotic illness or non-psychotic bipolar disorder who had experienced a hospital admission within the previous two years . Intervention The joint crisis plan was formulated by the patient , care coordinator , psychiatrist , and project worker and contained contact information , details of mental and physical illnesses , treatments , indicators for relapse , and advance statements of preferences for care in the event of future relapse . Main outcome measures Admission to hospital , bed days , and use of the Mental Health Act over 15 month follow up . Results Use of the Mental Health Act was significantly reduced for the intervention group , 13 % ( 10/80 ) of whom experienced compulsory admission or treatment compared with 27 % ( 21/80 ) of the control group ( risk ratio 0.48 , 95 % confidence interval 0
Output:
| Similarly , no significant differences were found for compliance with treatment , self harm or number of arrests . |
MS211631 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Abstract Objective .—To determine the efficacy of 2 different sources of Ginkgo biloba extract ( GBE ) in reducing the incidence and severity of acute mountain sickness ( AMS ) following rapid ascent to high altitude . Methods .—Two r and omized , double-blind , placebo-controlled cohort studies were conducted in which participants were treated with GBE ( 240 mg·d−1 ) or placebo prior to and including the day of ascent from 1600 m to 4300 m ( ascent in 2 hours by car ) . Acute mountain sickness was diagnosed if the Environmental Symptom Question naire III acute mountain sickness – cerebral ( AMS-C ) score was ≥0.7 and the Lake Louise Symptom ( LLS ) score was ≥3 and the participant reported a headache . Symptom severity was also determined by these scores . Results .— Results were conflicting : Ginkgo biloba reduced the incidence and severity of AMS compared to placebo in the first but not the second study . In the first study , GBE reduced AMS incidence ( 7/21 ) vs placebo ( 13/19 ) ( P = .027 , number needed to treat = 3 ) , and it also reduced severity ( AMS-C = 0.77 ± 0.26 vs 1.59 ± 0.27 , P = .029 ) . In the second study , GBE did not reduce incidence or severity of AMS ( GBE 4/15 vs placebo 10/22 , P = .247 ; AMS-C = 0.48 ± 0.13 vs 0.58 ± 0.11 , P = .272 ) . The primary difference between the 2 studies was the source of GBE . Conclusions .—The source and composition of GBE products may determine the effectiveness of GBE for prophylaxis of AMS BACKGROUND Acute mountain sickness ( AMS ) commonly occurs when unacclimatized individuals ascend to altitudes above 2000 m. Acetazolamide and Ginkgo biloba have both been recommended for AMS prophylaxis ; however , there is conflicting evidence regarding the efficacy of Ginkgo biloba use . We performed a r and omized , placebo-controlled trial of acetazolamide vs Ginkgo biloba for AMS prophylaxis . METHODS We r and omized unacclimatized adults to receive acetazolamide , Ginkgo biloba , or placebo in double-blind fashion and took them to an elevation of 3800 m for 24 hours . We grade d AMS symptoms using the Lake Louise Acute Mountain Sickness Scoring System ( LLS ) and compared the incidence of AMS ( defined as LLS score > or =3 and headache ) . RESULTS Fifty-seven subjects completed the trial ( 20 received acetazolamide ; 17 , Ginkgo biloba , and 20 , placebo ) . The LLS scores were significantly different between groups ; the median score of the acetazolamide group was significantly lower than that of the placebo group ( P=.01 ; effect size , 2 ; and 95 % confidence interval [ CI ] , 0 to 3 ) , unlike that of the Ginkgo biloba group ( P=.89 ; effect size , 0 ; and 95 % CI , -2 to 2 ) . Acute mountain sickness occurred less frequently in the acetazolamide group than in the placebo group ( effect size , 30 % ; 95 % CI , 61 % to -15 % ) , and the frequency of occurrence was similar between the Ginkgo biloba group and the placebo group ( effect size , -5 % ; 95 % CI , -37 % to 28 % ) . CONCLUSIONS In this study , prophylactic acetazolamide therapy decreased the symptoms of AMS and trended toward reducing its incidence . We found no evidence of similar efficacy for Ginkgo biloba BACKGROUND Acute mountain sickness ( AMS ) is a pathophysiological symptom complex that occurs in high-altitude areas . The incidence of AMS on Jade Mountain , the highest peak in Taiwan ( 3952 m ) , has been reported to be ∼36 % . There is a lack of data in children trekking at altitude in Taiwan . The purpose of this study was to determine the incidence , risk factors and symptoms of AMS in children trekking on Jade Mountain , Taiwan . METHODS This prospect i ve cohort study included a total of 96 healthy non-acclimatized children aged 11 - 12 years who trekked from an elevation of 2600 - 3952 m in 3 days . The Lake Louise AMS score was used to record symptoms associated with AMS . RESULTS AMS were reported in 59 % of children trekking on Jade Mountain over a 3 day period . AMS incidence increased significantly with increasing altitude . The most common AMS symptom was headache , followed by fatigue or weakness , difficulty sleeping , dizziness or lightheadedness and gastrointestinal symptoms . Children who had experienced upper respiratory infection ( URI ) within the 7 days before their trek tended to have a greater risk for development of AMS . AMS incidence did not significantly differ according to gender , recent acute gastroenteritis , menstruation and body mass index . CONCLUSIONS The incidence of AMS in children trekking on Jade Mountain is greater than that observed in adults , and was associated with altitude and recent URI AIM To investigate the effect of ginkgo biloba extract ( EGb 761 ) on lung injury induced by intestinal ischemia/reperfusion ( II/R ) . METHODS The rat model of II/R injury was produced by clamping the superior mesenteric artery for 60 min followed by reperfusion for 180 min . The rats were r and omly allocated into sham , II/R , and EGb + II/R groups . In EGb + II/R group , EGb 761 ( 100 mg/kg per day ) was given via a gastric tube for 7 consecutive days prior to surgery . Rats in II/R and sham groups were treated with equal volumes of the vehicle of EGb 761 . Lung injury was assessed by light microscopy , wet-to-dry lung weight ratio ( W/D ) and pulmonary permeability index ( PPI ) . The levels of malondialdehyde ( MDA ) and nitrite/nitrate ( NO2(-)/NO3(- ) ) , as well as the activities of superoxide dismutase ( SOD ) and myeloperoxidase ( MPO ) were examined . Western blot was used to determine the expression of inducible nitric oxide synthase ( iNOS ) . RESULTS EGb 761 markedly improved mean arterial pressure and attenuated lung injury , manifested by the improvement of histological changes and significant decreases of pulmonary W/D and PPI ( P < 0.05 or 0.01 ) . Moreover , EGb 761 markedly increased SOD activity , reduced MDA levels and MPO activity , and suppressed NO generation accompanied by down-regulation of iNOS expression ( P < 0.05 or 0.01 ) . CONCLUSION The results indicate that EGb 761 has a protective effect on lung injury induced by II/R , which may be related to its antioxidant property and suppressions of neutrophil accumulation and iNOS-induced NO generation . EGb 761 seems to be an effective therapeutic agent for critically ill patients with respiratory failure related to Abstract Objective To evaluate the efficacy of ginkgo biloba , acetazolamide , and their combination as prophylaxis against acute mountain sickness . Design Prospect i ve , double blind , r and omised , placebo controlled trial . Setting Approach to Mount Everest base camp in the Nepal Himalayas at 4280 m or 4358 m and study end point at 4928 m during October and November 2002 . Participants 614 healthy western trekkers ( 487 completed the trial ) assigned to receive ginkgo , acetazolamide , combined acetazolamide and ginkgo , or placebo , initially taking at least three or four doses before continued ascent . Main outcome measures Incidence measured by Lake Louise acute mountain sickness score ≥ 3 with headache and one other symptom . Secondary outcome measures included blood oxygen content , severity of syndrome ( Lake Louise scores ≥ 5 ) , incidence of headache , and severity of headache . Results Ginkgo was not significantly different from placebo for any outcome ; however participants in the acetazolamide group showed significant levels of protection . The incidence of acute mountain sickness was 34 % for placebo , 12 % for acetazolamide ( odds ratio 3.76 , 95 % confidence interval 1.91 to 7.39 , number needed to treat 4 ) , 35 % for ginkgo ( 0.95 , 0.56 to 1.62 ) , and 14 % for combined ginkgo and acetazolamide ( 3.04 , 1.62 to 5.69 ) . The proportion of patients with increased severity of acute mountain sickness was 18 % for placebo , 3 % for acetazoalmide ( 6.46 , 2.15 to 19.40 , number needed to treat 7 ) , 18 % for ginkgo ( 1 , 0.52 to 1.90 ) , and 7 % for combined ginkgo and acetazolamide ( 2.95 , 1.30 to 6.70 ) . Conclusions When compared with placebo , ginkgo is not effective at preventing acute mountain sickness . Acetazolamide 250 mg twice daily afforded robust protection against symptoms of acute mountain sickness Acetazolamide and gingko biloba are the two most investigated drugs for the prevention of acute mountain sickness ( AMS ) . Evidence suggests that they may also reduce pulmonary artery systolic pressure ( PASP ) . To investigate whether these two drugs for AMS prevention also reduce PASP with rapid airlift ascent to high altitude , a r and omized controlled trial was conducted on 28 healthy young men with acetazolamide ( 125 mg bid ) , gingko biloba ( 120 mg bid ) , or placebo for 3 days prior to airlift ascent ( 397 m ) and for the first 3 days at high altitude ( 3658 m ) . PASP , AMS , arterial oxygen saturation ( Sao2 ) , mean arterial pressure ( MAP ) , heart rate ( HR ) , forced vital capacity ( FVC ) , forced expiratory volume in the first second ( FEV1 ) , and peak expiratory flow ( PEF ) were assessed both at 397 m and 3658 m. HR , PEF , and PASP increased with altitude exposure ( p<0.05 ) , and SaO2 decreased ( p<0.05 ) . PASP with acetazolamide ( mean at 3658 m , 26.2 mm Hg ; incremental change , 4.7 mm Hg , 95 % CI . , 2.6 - 6.9 mm Hg ) was lower than that with ginkgo biloba ( mean at 3658 m , 33.7 mm Hg , p=0.001 ; incremental change , 13.1 mm Hg , 95%CI . , 9.6 - 16.5 mm Hg , p=0.002 ) , and with placebo ( mean at 3658 m , 34.7 mm Hg , p<0.001 ; 14.4 mm Hg , 95 % CI . , 8.8 - 20.0 mm Hg , p=0.001 ) . The data show that a low prophylactic dosage of acetazolamide , but not gingko biloba , mitigates the early increase of PASP in a quick ascent profile Previous studies suggest that 5 days of prophylactic ginkgo decreases the incidence of acute mountain sickness ( AMS ) during gradual ascent . This trial was design ed to determine if ginkgo is an effective prophylactic agent if begun 1 day prior to rapid ascent . In this double-blind , r and omized , placebo-controlled trial , 26 participants residing at sea level received ginkgo ( 60 mg TID ) or placebo starting 24 h before ascending Mauna Kea , Hawaii . Subjects were transported from sea level to the summit ( 4205 m ) over 3 hours , including 1 hour at 2835 m. The Lake Louise Self-report Question naire constituted the primary outcome measure at baseline , 2835 m , and after 4 h at 4205 m. AMS was defined as a Lake Louise Self-report Score ( LLSR ) > /= 3 with headache . Subjects who developed severe AMS were promptly transported to lower altitude for the remainder of the study . The ginkgo ( n = 12 ) and placebo ( n = 14 ) groups were well matched ( 58 % vs. 50 % female ; median age 28 yr , range 22 - 53 vs. 33 yr , range 21 - 53 ; 58 % vs. 57 % Caucasian ) . Two ( 17 % ) subjects on ginkgo and nine ( 64 % ) on placebo developed severe AMS and required descent for their safety ( p = 0.021 ) ; all recovered without sequelae . Median LLSR at 4205 m was significantly
Output:
| The currently available data suggest that although GBE may tend towards AMS prophylaxis , there are not enough data to show the statistically significant effect of GBE on preventing AMS . |
MS211632 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Recent efforts suggest an etiologic role of hepatitis B virus ( HBV ) infection in intrahepatic cholangiocarcinoma ( ICC ) and the involvement of hepatic progenitor cell in ICC development , without definitive conclusions . This case-control study was undertaken to investigate risk factors for ICC , and clinicopathological features of HBV-associated ICC were analyzed . Methods The report comprised 98 patients with pathologically confirmed ICC and 196 healthy control subjects . Logistic regression was used to determine odds ratios and 95 % confidence intervals . The sex and age distributions of HBV-related and unrelated ICC patients were compared respectively with those of 882 HBV-associated hepatocellular carcinoma patients from a r and om selection , and the clinicopathological data of 62 ICC patients with or without HBV infection undergoing surgical resection were compared . Results There was an association between ICC and each of HBV infection , liver cirrhosis , hepatolithiasis , and liver fluke infestation with the odds ratios ( 95 % confidence intervals ) of 2.75 ( 1.27–5.95 ) , 8.42 ( 2.50–28.37 ) , 22.81 ( 7.16–72.68 ) , and 3.55 ( 1.60–7.89 ) , respectively , with a marked synergism of cirrhosis and HBV infection ( 20.67 ; 5.40–79.06 ) . Compared with HBV-unrelated ICC patients , HBV-related ICC patients were more common in male and younger subjects , had a higher incidence of abnormal serum alfa-fetoprotein level , cirrhosis , and neutrophilic infiltration , and had a lower proportion of elevated carbohydrate antigen 19 - 9 ( CA19 - 9 ) values . Conclusions The independent association of HBV infection with ICC , synergy between cirrhosis and HBV infection , and some clinicopathological similarities between HBV-related ICC and hepatocellular carcinoma suggests that both may share similar or common tumorigenic process and may possibly originate from malignant transformation of hepatic progenitor cell A health survey of more than 143,000 radiologic technologists is described . The population was identified from the 1982 computerized files of the American Registry of Radiologic Technologists , which was established in 1926 . Inactive members were traced to obtain current addresses or death notifications . More than 6000 technologists were reported to have died . For all registrants who were alive when located , a detailed 16‐page question naire was sent , covering occupational histories , medical conditions , and other personal and lifestyle characteristics . Nonrespondents were contacted by telephone to complete an abbreviated question naire . More than 104,000 responses were obtained . The overall response rate was 79 % . Most technologists were female ( 76 % ) , white ( 93 % ) , and employed for an average of 12 years ; 37 % attended college , and approximately 50 % never smoked cigarettes . Radiation exposure information was sought from employer records and commercial dosimetry companies . Technologists employed for the longest times had the highest estimated cumulative exposures , with approximately 9 % with exposures greater than 5 cGy . There was a high correlation between cumulative occupational exposure and personal exposure to medical radiographs , related , in part , to the association of both factors with attained age . It is interesting that 10 % of all technologists allowed others to practice taking radiographs on them during their training . Nearly 4 % of the respondents reported having some type of cancer , mainly of the skin ( 1517 ) , breast ( 665 ) , and cervix ( 726 ) . Prospect i ve surveys will monitor cancer mortality rates through use of the National Death Index and cancer incidence through periodic mailings of question naires . This is the only occupational study of radiation employees who are primarily women and should provide new information on the possible risks associated with relatively low levels of exposure.586‐598 Background . Ovarian cancer is the fifth most common cause of cancer‐related death in American women . The median age at diagnosis is about 62 years ; incidence rises rapidly after age 60 . Pelvic examination has been the primary method for detection of ovarian carcinoma . It is insensitive for the detection of early disease , however : most women present with disease beyond the pelvis ( Stages III and IV ) and are not curable with existing techniques . Two new technologies may be useful as screening tools for earlier detection of ovarian cancer . CA 125 is an antigenic determinant expressed on an ovarian cancer cell line . Transvaginal ultrasound ( TVUS ) images the ovaries from within the vagina and can be performed by a technician in about 10 minutes . In small preoperative studies of women with ovarian masses , serum CA 125 levels have been elevated ( typically above 35 U/ml ) in over two‐thirds of cases and in up to 50 % of Stage I cases . The test is not absolutely specific : elevations have been reported with pregnancy , endometriosis , menstruation , benign ovarian tumors , and with cancers of the breast , colon , pancreas , lung , stomach , and liver . Nevertheless , the specificity of CA 125 in postmenopausal women has been reported at about 95 % or more . TVUS provides higher resolving power for ovarian abnormalities than transabdominal ultrasound or physical examination ; however , experience with it is limited . CA 125 and TVUS may be complementary BACKGROUND Recent findings have cast doubt on the hypothesis that high intakes of fruit and vegetables are associated with a reduced risk of colorectal cancer . OBJECTIVE In a large prospect i ve cohort of women , we examined the association between fruit and vegetable intakes and colorectal cancer . DESIGN Between 1987 and 1989 , 45490 women with no history of colorectal cancer satisfactorily completed a 62-item Block-National Cancer Institute food-frequency question naire . During 386142 person-years of follow-up , 314 women reported incident colorectal cancer , search es of the National Death Index identified an additional 106 colorectal cancers , and a match with state registries identified another 65 colorectal cancers for a total of 485 cases . We used Cox proportional hazards regression analysis to estimate the relative risks ( RRs ) and 95 % CIs in both energy-adjusted and fully adjusted models . RESULTS In models using the multivariate nutrient-density model of energy adjustment , RRs for increasing quintile of fruit consumption indicated no significant association with colorectal cancer [ RR ( 95 % CI ) ] : 1.00 ( reference ) , 0.94 ( 0.70 , 1.26 ) , 0.85 ( 0.63 , 1.15 ) , 1.07 ( 0.81 , 1.42 ) , and 1.09 ( 0.82 , 1.44 ) . For vegetable consumption , there was also no significant association in the multivariate nutrient-density model with increasing quintiles of consumption : 1.00 ( reference ) , 0.77 ( 0.58 , 1.02 ) , 0.83 ( 0.63 , 1.10 ) , 0.90 ( 0.69 , 1.19 ) , and 0.92 ( 0.70 , 1.22 ) . Additionally , 3 alternative models of energy adjustment showed no significant association between increases in vegetable intake and the risk of colorectal cancer . CONCLUSION Although the limitations of our study design and data merit consideration , this investigation provides little evidence of an association between fruit and vegetable intakes and colorectal cancer Incidence rates for liver cancer have increased 3-fold since the mid-1970s in the United States in parallel with increasing trends for obesity and type II diabetes mellitus . We conducted an analysis of baseline body mass index ( BMI ) , waist circumference ( WC ) , and type II diabetes mellitus with risk of liver cancer . The Liver Cancer Pooling Project maintains harmonized data from 1.57 million adults enrolled in 14 U.S.-based prospect i ve studies . Cox regression estimated HRs and 95 % confidence intervals ( CI ) adjusted for age , sex , study center , alcohol , smoking , race , and BMI ( for WC and type II diabetes mellitus ) . Stratified analyses assessed whether the BMI -liver cancer associations differed by hepatitis sera-positivity in nested analyses for a subset of cases ( n = 220 ) and controls ( n = 547 ) . After enrollment , 2,162 incident liver cancer diagnoses were identified . BMI , per 5 kg/m2 , was associated with higher risks of liver cancer , more so for men ( HR = 1.38 ; 95 % CI , 1.30 - 1.46 ) than women ( HR = 1.25 ; 95 % CI , 1.17 - 1.35 ; Pinteraction = 0.02 ) . WC , per 5 cm , was associated with higher risks of liver cancer , approximately equally by sex ( overall , HR = 1.08 ; 95 % CI , 1.04 - 1.13 ) . Type II diabetes mellitus was associated with higher risk of liver cancer ( HR = 2.61 ; 95 % CI , 2.34 - 2.91 ) . In stratified analyses , there was a null association between BMI and liver cancer risk for participants who were sera-positive for hepatitis . This study suggests that high BMI , high WC , and type II diabetes mellitus are associated with higher risks of liver cancer and that the association may differ by status of viral hepatitis infection . Cancer Res ; 76(20 ) ; 6076 - 83 . © 2016 AACR Background : Hepatocellular carcinoma ( HCC ) occurs less commonly among women than men in almost all regions of the world . The disparity in risk is particularly notable prior to menopause suggesting that hormonal exposures during reproductive life may be protective . Exogenous oestrogenic exposures such as oral contraceptives ( OCs ) , however , have been reported to increase risk , suggesting that estrogens may be hepatocarcinogenic . To examine the effects of reproductive factors and exogenous hormones on risk , we conducted a prospect i ve analysis among a large group of US women . Methods : In the Liver Cancer Pooling Project , a consortium of US-based cohort studies , data from 799 500 women in 11 cohorts were pooled and harmonised . Cox proportional hazards regression models were used to generate hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) for the associations of reproductive factors and exogenous hormones with HCC ( n=248 ) . Results : Bilateral oophorectomy was associated with a significantly increased risk of HCC ( HR=2.67 , 95 % CI=1.22–5.85 ) , which did not appear to be related to a shorter duration of exposure to endogenous hormones or to menopausal hormone therapy use . There was no association between OC use and HCC ( HR=1.12 , 95 % CI=0.82–1.55 ) . Nor were there associations with parity , age at first birth , age at natural menopause , or duration of fertility . Conclusions : The current study suggests that bilateral oophorectomy increases the risk of HCC but the explanation for the association is unclear . There was no association between OC use and HCC risk . Examination of endogenous hormone levels in relation to HCC may help to clarify the findings of the current study Summary A cohort study is under way in New York City to evaluate how levels of endogenous reproductive hormones influence the risk of breast cancer . The study , in which approximately 15,000 women are being recruited , utilizes a prospect i ve design in which volunteers are asked to provide repeated specimens of serum during the period 1985–1992 . A case-control study nested within the cohort is planned by which specimens from all cases arising in the population and from a r and omly selected sample of time-matched controls will be analyzed and compared . As of December 31 , 1989 , 13,609 volunteers had donated blood specimens , about 50 % of whom had already donated more than once . Of the 187 incident breast cancer cases who are expected to arise in the cohort before the end of 1992 , 77 have been detected thus far Recent epidemiologic evidence indicates an association between fat distribution and many diseases . To assess the validity of circumference measurements obtained by self-report , the authors analyzed data from 123 men aged 4C75 years and 140 women aged 41–65 years , drawn from two large ongoing prospect i ve studies . On mailed question naires , subjects were asked to measure and record their weight and waist and hip circumferences . These data were compared with st and ardized measurements taken approximately six months apart by technicians who visited participants at their homes . Crude Pearson correlations between self-reported waist circumferences and the average of two technician-measured waist circumferences were 0.95 for men and 0.89 for women . Similar correlations for hip measurements were 0.88 for men and 0.84 for women , and for waist-to-hip ratios , 0.69 for men and 0.70 for women . After adjusting for age and body mass index ( kg/m2 ) , correl
Output:
| : These findings suggest that obesity and diabetes are associated with increased ICC risk , highlighting similar etiologies of hepatocellular carcinoma and intrahepatic cholangiocarcinoma . |
MS211633 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: This study examined the relationship between objective ly measured nocturnal hot flashes and objective ly measured sleep in breast cancer survivors with insomnia . Twenty-four women who had completed treatment for non-metastatic breast cancer participated . All were enrolled in a study of cognitive-behavioral treatment for chronic insomnia . Nocturnal hot flashes and sleep were measured by skin conductance and polysomnography , respectively . The 10-minute periods around hot flashes were found to have significantly more wake time , and more stage changes to lighter sleep , than other 10-minute periods during the night . Nights with hot flashes had a significantly higher percentage of wake time , a lower percentage of Stage 2 sleep , and a longer REM latency compared to nights without hot flashes . Overall , hot flashes were found to be associated with less efficient , more disrupted sleep . Nocturnal hot flashes , or their underlying mechanisms , should be considered as potential contributors to sleep disruption in women with breast cancer who report poor sleep ABSTRACT Epidemiological and animal studies have suggested an association between habitual sleep patterns and cardiovascular ( CV ) disease , but the results are still controversial . Therefore , the aims of this study are to investigate the relationships between habitual sleep patterns and CV disease based on Prospect i ve Urban Rural Epidemiology ( PURE ) China study . PURE China study recruited 46 285 participants , aged 35–70 , from 12 provinces and 115 communities in China . Habitual sleep patterns and CV disease were self-reported . Multilevel logistic regression was used in our analysis . In this study , 39 515 participants were eligible in our analysis , including 23 345 ( 59.1 % ) women and 16 170 ( 40.9 % ) men . Sleeping ≥9 h per day was associated with increased odds of CV disease ( OR = 1.16 , 95 % CI : 1.01–1.32 , p = 0.033 ) compared with sleeping 7–8 h per day . Taking daytime naps was also associated with an increased odds of CV disease , and the CV odds increased with increasing napping duration ( p for trend < 0.001 ) . For the sleeping < 6 h per day , we only found an association with coronary artery disease ( CAD ) ( OR = 1.58 , 95 % CI : 1.01–2.48 , p = 0.046 ) . Participants with only 7–8 h sleep per night had lowest prevalence of CV disease ( OR = 0.77 , 95 % CI : 0.65–0.90 , p = 0.001 ) compared with other sleep patterns . Napping , long and short duration of habitual sleep may increase the odds of CV disease . Only participants sleeping 7–8 hours at night are recommended in this study , and large longitudinal studies are needed to confirm these results Hypotheses . Sleep disorders are associated with an increased risk of cancer , including breast cancer ( BC ) . Physical activity ( PA ) can produce beneficial effects on sleep . Study design . We design ed a r and omized controlled trial to test the effect of 3 months of physical activity on sleep and circadian rhythm activity level evaluated by actigraphy . Methods . 40 BC women , aged 35 - 70 years , were r and omized into an intervention ( IG ) and a control group ( CG ) . IG performed a 3 month of aerobic exercise . At baseline and after 3 months , the following parameters were evaluated both for IG and CG : anthropometric and body composition measurements , energy expenditure and motion level ; sleep parameters ( Actual Sleep Time-AST , Actual Wake Time-AWT , Sleep Efficiency-SE , Sleep Latency-SL , Mean Activity Score-MAS , Movement and Fragmentation Index-MFI and Immobility Time-IT ) and activity level circadian rhythm using the Actigraph Actiwatch . Results . The CG showed a deterioration of sleep , whereas the IG showed a stable pattern . In the CG the SE , AST and IT decreased and the AWT , SL , MAS and MFI increased . In the IG , the SE , IT , AWT , SL , and MAS showed no changes and AST and MFI showed a less pronounced change in the IG than in the CG . The rhythmometric analysis revealed a significant circadian rhythm in two groups . After 3 months of PA , IG showed reduced fat mass % , while CG had improved weight and BMI . Conclusion . Physical activity may be beneficial against sleep disruption . Indeed , PA prevented sleep worsening in IG . PA can represent an integrative intervention therapy able to modify sleep behaviour Background Many breast cancer survivors experience fatigue , mood , and sleep disturbances . Purpose This study aims to compare a meditative movement practice , Qigong/Tai Chi Easy ( QG/TCE ) with sham Qigong ( SQG ) , testing effects of meditation/breath aspects of QG/TCE on breast cancer survivors ’ persistent fatigue and other symptoms . Methods This double-blind , r and omized controlled trial tested 12 weeks of QG/TCE versus SQG on fatigue , depression , and sleep among 87 postmenopausal , fatigued breast cancer survivors , stages 0–III , age 40–75 . Results Fatigue decreased significantly in the QG/TCE group compared to control at post-intervention ( p = 0.005 ) and 3 months follow-up ( p = 0.024 ) , but not depression and sleep quality . Improvement occurred over time for both interventions in depression and sleep quality ( all p < 0.05 ) . Conclusions QG/TCE showed significant improvement over time compared to SQG for fatigue , but not depression or sleep . Both QG/TCE and SQG showed improvement for two prevalent symptoms among breast cancer survivors , depression and sleep dysfunction OBJECTIVE To investigate the associations between sleep duration and mortality in the elderly by controlling for sleep quality . METHOD Data were collected from participants in a cohort study in Shizuoka , Japan . A total of 14,001 elderly residents ( aged 65 - 85 years ) , r and omly chosen from all 74 municipalities in the prefecture , completed question naires that evaluated sleep duration , sleep complaints , and the use of hypnotics . Participants were followed from 1999 to 2006 . We analyzed 11,395 subjects to estimate the hazard ratios ( HR ) for mortality from all causes and cardiovascular disease ( CVD ) . RESULTS With 60,252 person-years , 1004 deaths were identified . While short sleep duration and mortality were not associated , longer sleep duration was associated with higher risk of mortality in both sexes . Compared with those who slept 7 h , the multivariate HR and 95 % confidence interval of CVD mortality for those who slept > or = 10 h was 1.95 ( 1.18 - 3.21 ) and , for those who slept < or = 5 h , it was 1.10 ( 0.62 - 1.93 ) . Although no clear association was found between sleep quality and mortality , long sleep duration was associated with higher risk of CVD mortality among those with poor sleep quality . CONCLUSION Long sleep duration is associated with higher risk of CVD mortality among the elderly with poor sleep quality OBJECTIVE To improve mechanistic underst and ing , this pilot r and omized controlled trial examined mediators of an exercise intervention effects on sleep in breast cancer survivors ( BCS ) . METHODS Forty-six postmenopausal BCS ( ≤Stage II , off primary treatment ) were r and omized to a 3-month exercise intervention or control group . Intervention included 160 min/week of moderate intensity aerobic walking , twice weekly resistance training ( resistance b and s ) , and six discussion groups ( to improve adherence ) . Blinded assessment s at baseline and post-intervention included sleep disturbance ( PSQI and PROMIS ® ) , objective sleep quality ( accelerometer ) , serum cytokines , accelerometer physical activity , cardiorespiratory fitness , body composition , fatigue , and psychosocial factors . Mediation was tested using Freedman-Schatzkin difference-in-coefficients tests . RESULTS When compared with control , the intervention group demonstrated a significant increase in PSQI sleep duration ( i.e. , fewer hours of sleep/night ) ( d = 0.73 , p = .03 ) . Medium to large but non-significant st and ardized effect sizes were noted for PSQI daytime somnolence ( d = -0.63 , p = .05 ) and accelerometer latency ( d = -0.49 , p = .14 ) . No statistically significant mediators were detected for PSQI sleep duration score or accelerometer latency . Daytime somnolence was mediated by tumor necrosis factor-alpha ( mediated 23 % of intervention effect , p < .05 ) , interleukin (IL)-6:IL-10 ( 16 % , p < .01 ) , IL-8:IL-10 ( 26 % , p < .01 ) , and fatigue ( 38 % , p < .05 ) . Mediating or enhancing relationships for several of the sleep outcomes were noted for accelerometer physical activity , PROMIS ® fatigue , exercise social support , and /or physical activity enjoyment . CONCLUSIONS Inflammation and psychosocial factors may mediate or enhance sleep response to our exercise intervention . Further study is warranted to confirm our results and translate our findings into more effective interventions aim ed at improving sleep quality in BCS Background Cancer-related fatigue ( CRF ) and insomnia are major complaints in breast cancer survivors ( BC ) . Aerobic training ( AT ) , the st and ard therapy for CRF in BC , shows only minor to moderate treatment effects . Other evidence -based treatments include cognitive behavioral therapy , e.g. , sleep education/restriction ( SE ) and mindfulness-based therapies . We investigated the effectiveness of a 10-week multimodal program ( MT ) consisting of SE , psycho-education , eurythmy- and painting-therapy , administered separately or in combination with AT ( CT ) and compared both arms to AT alone . Methods In a pragmatic comprehensive cohort study BC with chronic CRF were allocated r and omly or by patient preference to ( a ) MT , ( b ) CT ( MT + AT ) or ( c ) AT alone . Primary endpoint was a composite score of the Pittsburgh Sleep Quality Index and the Cancer Fatigue Scale after 10 weeks of intervention ( T1 ) ; a second endpoint was a follow-up assessment 6 months later ( T2 ) . The primary hypothesis stated superiority of CT and non-inferiority of MT vs. AT at T1 . A closed testing procedure preserved the global α-level . The intention-to-treat analysis included propensity scores for the mode of allocation and for the preferred treatment , respectively . Results Altogether 126 BC were recruited : 65 were r and omized and 61 allocated by preference ; 105 started the intervention . Socio-demographic parameters were generally balanced at baseline . Non-inferiority of MT to AT at T1 was confirmed ( p < 0.05 ) , yet the confirmative analysis stopped as it was not possible to confirm superiority of CT vs. AT ( p = 0.119 ) . In consecutive exploratory analyses MT and CT were superior to AT at T1 and T2 ( MT ) or T2 alone ( CT ) , respectively . Conclusions The multimodal CRF-therapy was found to be confirmatively non-inferior to st and ard therapy and even yielded exploratively sustained superiority . A r and omized controlled trial including a larger sample size and a longer follow-up to evaluate multimodal CRF-therapy is highly warranted . Trial registerDRKS-ID : DRKS00003736 . Recruitment period June 2011 to March 2013 . Date of registering 19 June 2012 PURPOSE S/ OBJECTIVES To test the hypothesis that women participating in a walking exercise program during radiation therapy treatment for breast cancer would demonstrate more adaptive responses as evidence d by higher levels of physical functioning and lower levels of symptom intensity than women who did not participate . DESIGN Experimental , two-group pretest , post-test . SETTING Two university teaching hospital outpatient radiation therapy departments . SAMPLE 46 women beginning a six-week program of radiation therapy for early stage breast cancer . METHODS Following r and om assignment , subjects in the exercise group maintained an individualized , self-paced , home-based walking exercise program throughout treatment . The control group received usual care . Dependent variables were measured prior to and at the end of radiation therapy . In addition , symptoms were assessed at the end of three weeks of treatment . MAIN RESEARCH VARIABLES Participation in the walking exercise program , physical functioning fatigue , emotional distress , and difficulty sleeping . FINDINGS Hypothesis testing by multivariate analysis of covariance , with pretest scores as covariates , indicated significant differences between groups on outcome measures ( p < 0.001 ) . The exercise group scored significantly higher than the usual care group on physical functioning ( p = 0.003 ) and symptom intensity , particularly fatigue , anxiety , and difficulty sleeping . Fatigue was the most frequent and intense subjective symptom reported . CONCLUSIONS A self-paced , home-based walking exercise program can help manage symptoms and improve physical functioning during radiation therapy . IMPLICATION S FOR NURSING PRACTICE Nurse-prescribed and -monitored exercise is an effective , convenient , and low-cost self-care activity that reduces symptoms and facilitates adaptation to breast cancer diagnosis and treatment PURPOSE Interventions to increase physical activity among breast cancer survivors are needed to improve health and quality of life and possibly to reduce the risk of disease recurrence and early mortality . Therefore , we report the feasibility and preliminary outcomes of a pilot r and omized trial design ed to increase physical activity in sedentary breast cancer survivors receiving horm
Output:
| Subgroup analyses revealed no clear differences between interventions conducted during versus after breast cancer treatment .
Regarding the objective measurements , no significant effects were found .
Conclusions Physical as well as mind – body exercise can improve subjective sleep problems in breast cancer patients .
In contrast , there was no effect of exercise on objective sleep measures . |
MS211634 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE This study examined the effects of oral estrogen ( ERT ) alone versus oral estrogen/medroxyprogesterone acetate ( HRT ) therapy on cardiovascular function , as controlled by the autonomic nervous system . STUDY DESIGN Forty-three postmenopausal women received ERT , HRT , or a placebo for 3 months in a double-blind , r and omized , placebo-controlled study . Cardiovascular hemodynamics and heart rate variability were assessed at rest and during stress . RESULTS After 3 months of therapy , oral HRT significantly increased high-frequency power ( P = .0002 ) and decreased total peripheral resistance ( P = .04 ) . The changes were evident at rest and during stress . CONCLUSION Our findings suggest that combination therapy produces a more favorable alteration of autonomic cardiovascular function than estrogen alone ( ie , combination therapy increases vagal activity ) Women often exhibit larger hormonal and subjective responses to opioid receptor antagonists than men , but the biological mechanisms mediating this effect remain unclear . Among women , fluctuations in estradiol ( E2 ) and progesterone ( P4 ) across the menstrual cycle ( MC ) affect the endogenous opioid system . Therefore , the goal of the current study was to compare acute naltrexone response between women in the early follicular phase of the MC ( low E2 and P4 ) , women in the luteal phase of the MC ( high E2 and P4 ) , and men . Seventy healthy controls ( n=46 women ) participated in two morning sessions in which they received 50 mg naltrexone or placebo in a r and omized , counterbalanced order . Women were r and omized to complete both sessions in either the early follicular ( n=23 ) or luteal phase of the MC . Serum cortisol , salivary cortisol , prolactin , luteinizing hormone ( LH ) , and subjective response were assessed upon arrival to the laboratory and at regular intervals after pill administration . In luteal and early follicular women but not men , naltrexone ( vs. placebo ) increased serum cortisol and prolactin levels from baseline ; however , the naltrexone-induced increases in these hormones were significantly greater in luteal women than early follicular women . Additionally , only luteal women demonstrated an increase from baseline in salivary cortisol levels and the severity of adverse drug effects in response to naltrexone . In sum , the results indicate that luteal phase women are more sensitive to acute hormonal and subjective effects of naltrexone than early follicular women and men . These findings may have important implication s for the use of naltrexone in women BACKGROUND Heavy alcohol consumption is associated with menstrual irregularities , including anovulation , luteal-phase dysfunction , recurrent amenorrhea , and early menopause . In addition , moderate to heavy alcohol intake has been found to increase the risk of spontaneous abortions and breast cancer . These adverse effects could at least in part originate from alcohol-mediated changes in hormone levels . METHODS The acute effect of alcohol on the hormone balance in women using oral contraceptives ( OC+ ) and also in nonusers ( OC- ) , was evaluated in 30 OC- and 31 OC+ subjects , representing the whole period of the menstrual cycle . It was also evaluated in 40 OC- and 47 OC+ subjects during the midcycle phase and in 10 OC+ subjects with unknown cycle phase . RESULTS We found that among subjects who used oral contraceptives , estradiol levels increased and progesterone levels decreased after intake of alcohol ( 0.5 g/kg ) . No dose effect ( 0.34 - 1.02 g/kg ) on progesterone was observed in a sub study on 10 OC+ subjects . With regard to estrone levels , no effect was observed , although a significant increase was found in the estradiol-to-estrone ratio . Among subjects not using oral contraceptives , progesterone levels decreased after intake of alcohol ( 0.5 g/kg ) . No effect was found in estradiol , estrone , or the estradiol-to-estrone ratio during midcycle in this study group . A transient elevating effect of alcohol ( 0.5 g/kg ) on prolactin levels was observed in both study groups . We found that alcohol ( 0.5 g/kg ) had no significant effect on luteinizing hormone ( LH ) levels among subjects not using oral contraceptives , and observed a decline among subjects using oral contraceptives at midcycle . CONCLUSIONS We suggest that the estradiol and progesterone effects are related to decreased steroid catabolism , result ing from the alcohol-mediated increase in the hepatic NADH-to-NAD ratio . The transient effect on prolactin levels may reflect acute changes in opioid and dopamine levels in the hypothalamus . The present findings regarding female sex steroids may be of relevance in the association between moderate to heavy alcohol consumption and the development of breast cancer Introduction Prolonged exercise requires increased utilization of blood glucose and adjustment of glucoregulatory hormones . Estrogen can reduce hepatic gluconeogenesis which could affect insulin concentrations . Amylin is co-secreted with insulin and controls influx of glucose into the blood . Purpose To determine the effect of menstrual cycle stage on glucose , leptin , and pancreatic hormone responses to prolonged ( 90 min ) exercise . Methods Five healthy , eumenorrheic women ( 24.6 ± 5.1 years ; 67.4 ± 1 kg ) were monitored for 3 months to determine menstrual cycle length . Subjects completed a preliminary session to determine exercise workloads and , in a fasted condition , completed two r and omized 90-min treadmill exercise trials at 60 % VO2max during the early follicular ( EFX ) and mid-luteal phase ( MLX ) of their menstrual cycle . Blood sample s were analyzed for glucose , insulin , C-peptide , amylin , glucagon , leptin , and cortisol concentrations at rest ( −30 and 0 min ) , during exercise ( 18 , 36 , 54 , 72 , and 90 min ) and after 20 min of recovery . Results No changes in amylin , leptin , or cortisol occurred for EFX and MLX trials . A significant ( p < 0.05 ) time effect occurred for glucose , insulin , and glucagon with reduced insulin across the exercise trial and increases in glucose and glucagon later in the trial , but there were no differences between the EFX and MLX trials . Conclusions Menstrual cycle stage does not affect glucose , insulin , C-peptide , amylin , glucagon , cortisol , and leptin responses to prolonged exercise ; however , the exercise reduces insulin and increases glucose and glucagon concentrations . This is the first study to determine acute effects of exercise on amylin and other glucoregulatory hormone responses in women Background Chronic stress results from an imbalance of personal traits , re sources and the dem and s placed upon an individual by social and occupational situations . This chronic stress can be measured using the Trier Inventory for Chronic Stress ( TICS ) . Aims of the present study are to test the factorial structure of the TICS , report its psychometric properties , and evaluate the influence of gender and age on chronic stress . Methods The TICS was answered by N = 2,339 healthy participants aged 14 to 99 . The sample was selected by r and om-route sampling . Exploratory factor analyses with Oblimin-rotated Principal Axis extraction were calculated . Confirmatory factor analyses applying Robust Maximum Likelihood estimations ( MLM ) tested model fit and configural invariance as well as the measurement invariance for gender and age . Reliability estimations and effect sizes are reported . Results In the exploratory factor analyses , both a two-factor and a nine-factor model emerged . Confirmatory factor analyses result ed in acceptable model fit ( RMSEA ) , with model comparison fit statistics corroborating the superiority of the nine-factor model . Most factors were moderately to highly intercorrelated . Reliabilities were good to very good . Measurement invariance tests gave evidence for differential effects of gender and age on the factor structure . Furthermore , women and younger individuals , especially those aged 35 to 44 , tended to report more chronic stress than men and older individuals . Conclusions The proposed nine-factor structure could be factorially vali date d , results in good scale reliability , and heuristically can be grouped by two higher-order factors : " High Dem and s " and " Lack of Satisfaction " . Age and gender represent differentiable and meaningful contributors to the perception of chronic stress Evaluation of heart rate variability ( HRV ) is based on analysis of consecutive R-R intervals and may provide quantitative information on the modulation of cardiac vagal and sympathetic efferent activities . In particular , power spectral analysis as well as the fractal dimension of HRV represent non-invasive measures that reflect brain-heart interaction in different physiopathological conditions . This study was performed to investigate the relationship between autonomic nervous cardiac influence and three phases ( menses , follicular phase and luteal phase ) of the menstrual cycle . Heart rate ( HR ) was recorded in 6 eumenorrheic young females , continuously for 20 min , at rest . From the tachograms , fractal dimension , FFT spectra and beta coefficient were evaluated . The components of two spectral b and s were calculated : 0.040 Hz - 0.150 Hz ( low frequency , LF ) , and 0.150 Hz - 0.80 Hz ( high frequency , HF ) . The results indicate no correlation between HR and follicular as well as luteal phase of the menstrual cycle . Total power and HF spectral component increase , whereas LF spectral component decreases in the luteal phase compared to the follicular one . The fractal dimension does not show significant differences among the three phases . Beta coefficient decreases during luteal phase in respect of follicular one and menses . In conclusion , these results indicate in healthy young women a correlation between female sex hormones ( 17 beta-oestradiol , progesterone and pituitary gonadotrophins ) concentrations and some HRV parameters with higher HR variability during the luteal phase Estrogens are involved in the modulation of the cardiovascular system , yet their effects in young women remains largely unknown . Women who undergo ovulation induction treatments attain extremely high estrogen concentrations during a very short time period . The aim of the present study was to evaluate the effects of an acute increase in estrogens on the autonomic nervous system modulation of heart rate variability ( HRV ) . A total of 27 women undergoing ovulation induction and 14 normally menstruating women were prospect ively studied . HRV was assessed during nadir and peak estrogen using time domain and power spectral density analyses . A significant increase in high-frequency spectral power ( 243 ± 77 vs. 188 ± 73 ms2/Hz , P < 0.01 ) with a significant decrease in the ratio of low to high-frequency power was observed during estrogen peak in women undergoing induction of ovulation . The acute increase in estrogen in women undergoing ovulation induction was associated with vagal activation and altered sympathovagal balance BACKGROUND In this study we extended previous work by examining whether disturbances in the circadian rhythms of cortisol during the menstrual cycle distinguish patients with premenstrual dysphoric disorder ( PMDD ) from normal control ( NC ) subjects . In addition , we tested the differential response to the effects of early and late partial sleep deprivation on cortisol rhythms . METHODS In 15 PMDD and 15 NC subjects we measured cortisol levels every 30 min from 6:00 PM to 9:00 AM during midfollicular ( MF ) and late luteal ( LL ) menstrual cycle phases and also during a r and omized crossover trial of early ( sleep 3:00 AM-7:00 AM ) versus late ( sleep 9:00 PM-1:00 AM ) partial sleep deprivation administered in two subsequent and separate luteal phases . RESULTS In follicular versus luteal menstrual cycle phases we observed altered timing but not quantitative measures of cortisol secretion in PMDD subjects , compared with NC subjects : in the LL versus MF phase the cortisol acrophase was a mean of 1 hour earlier in NC subjects , but not in PMDD subjects . The effect of sleep deprivation on cortisol timing measures also differed for PMDD versus NC subjects : during late partial sleep deprivation ( when subjects ' sleep was earlier ) , the cortisol acrophase was almost 2 hours earlier in PMDD subjects . CONCLUSIONS Timing rather than quantitative measures of cortisol secretion differentiated PMDD subjects from NC subjects both during the menstrual cycle and in response to early versus late sleep deprivation interventions Resting heart rate and heart rate variability of 33 postmenopausal women were compared with those of 50 premenopausal women of comparable activity level , none of whom had used hormone replacement therapy . Heart rate was measured as the mean of at least 600 consecutive R‐R intervals obtained from electrocardiograph ( ECG ) records , and its variability as the st and ard deviation of these intervals . Activity levels were assessed by a scale modified from the Allied Dunbar National Fitness Survey ( 1992 ) . There was a significant reduction in both mean R‐R interval and the st and ard deviation in the postmenopausal women who had experienced their last menstrual period ( LMP ) 1 year or more prior to the observations being made , but no observable changes during the first year post menopause Measuring heart rate variability ( HRV ) is a way to assess the autonomic regulation of the
Output:
| Based on a systematic literature review of the impact of endogenous and exogenous exposure with natural progesterone on the stress response in healthy premenopausal and postmenopausal women , the following conclusions can be drawn : the HPAA activity was not relevantly affected by endogenous progesterone exposure across the menstrual cycle , but might be reduced by exogenous micronized progesterone application ; in contrast , the ANS has a sympathetic predominance in the ( progesterone-dominated ) luteal phase of the menstrual cycle . |
MS211635 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Introduction Hypothalamic-pituitary-adrenal ( HPA ) deregulation is commonly observed in cancer patients , but its clinical significance is not well understood . We prospect ively examined the association between HPA activity , tumor-associated inflammation , and survival in ovarian cancer patients prior to treatment . Material s and Methods Participants were 113 women with ovarian cancer who provided salivary cortisol for three days prior to treatment for calculation of cortisol slope , variability , and night cortisol . Cox proportional hazard regression analyses were used to examine associations between cortisol and survival in models adjusting for disease stage , tumor grade , cytoreduction and age . On a sub sample of 41 patients with advanced disease ascites fluid was assayed for levels of interleukin-6 ( IL-6 ) and correlated with cortisol variables . Results Each cortisol measure was associated with decreased survival time , adjusting for covariates ( all p<.041 ) . A one st and ard deviation increase in night cortisol was associated with a 46 % greater likelihood of death . Patients in the high night cortisol group survived an estimated average of 3.3 years compared to 7.3 years for those in the low night cortisol group . Elevated ascites IL-6 was associated with each cortisol measure ( all r > .36 , all p<.017 ) . Discussion Abnormal cortisol rhythms assessed prior to treatment are associated with decreased survival in ovarian cancer and increased inflammation in the vicinity of the tumor . HPA abnormalities may reflect poor endogenous control of inflammation , dysregulation caused by tumor-associated inflammation , broad circadian disruption , or some combination of these factors . Nocturnal cortisol may have utility as a non-invasive measure of HPA function and /or disease severity CONTEXT Changes in and rogen levels across the adult female life span and the effects of natural menopause and oophorectomy have not been clearly established . OBJECTIVE The objective of this study was to document the effects of age on and rogen levels in healthy women and to explore the effects of natural and surgical menopause . DESIGN , SETTING , AND PARTICIPANTS A cross-sectional study was conducted of 1423 non-healthcare-seeking women , aged 18 - 75 yr , r and omly recruited from the community over 15 months . MAIN OUTCOME MEASURES Serum levels by age of total testosterone ( T ) , calculated free T , dehydroepi and rosterone sulfate , and and rostenedione in a reference group of women free of confounding factors . Women in the reference group had no usage of exogenous steroid therapy ; no history of tubal ligation , hysterectomy , or bilateral oophorectomy ; and no hyperprolactinemia or polycystic ovarian syndrome . The effects of natural and surgical menopause on sex steroid levels were also examined . RESULTS In the reference population ( n = 595 ) , total T , calculated free T , dehydroepi and rosterone sulfate , and and rostenedione declined steeply with age ( P < 0.001 ) , with the decline of each being greater in the earlier than the later decades . Examination of serum and rogen levels by year in women aged 45 - 54 yr showed no independent effect of menopausal status on and rogen levels . In women aged 55 yr or older , those who reported bilateral oophorectomy and were not on exogenous steroids had significantly lower total T and free T levels than women 55 yr or older in the reference group . CONCLUSIONS We report that serum and rogen levels decline steeply in the early reproductive years and do not vary because a consequence of natural menopause and that the postmenopausal ovary appears to be an ongoing site of testosterone production . These significant variations in and rogens with age must be taken into account when normal ranges are reported and in studies of the role of and rogens in women Background Current reporting guidelines do not call for st and ardised declaration of follow-up completeness , although study validity depends on the representativeness of measured outcomes . The Follow-Up Index ( FUI ) describes follow-up completeness at a given study end date as ratio between the investigated and the potential follow-up period . The association between FUI and the accuracy of survival-estimates was investigated . Methods FUI and Kaplan-Meier estimates were calculated twice for 1207 consecutive patients undergoing aortic repair during an 11-year period : in a scenario A the population ’s clinical routine follow-up data ( available from a prospect i ve registry ) was analysed conventionally . For the control scenario B , an independent survey was completed at the predefined study end . To determine the relation between FUI and the accuracy of study findings , discrepancies between scenarios regarding FUI , follow-up duration and cumulative survival-estimates were evaluated using multivariate analyses . Results Scenario A noted 89 deaths ( 7.4 % ) during a mean considered follow-up of 30±28months . Scenario B , although analysing the same study period , detected 304 deaths ( 25.2 % , P<0.001 ) as it scrutinized the complete follow-up period ( 49±32months ) . FUI ( 0.57±0.35 versus 1.00±0 , P<0.001 ) and cumulative survival estimates ( 78.7 % versus 50.7 % , P<0.001 ) differed significantly between scenarios , suggesting that incomplete follow-up information led to underestimation of mortality . Degree of follow-up completeness ( i.e. FUI-quartiles and FUI-intervals ) correlated directly with accuracy of study findings : underestimation of long-term mortality increased almost linearly by 30 % with every 0.1 drop in FUI ( adjusted HR 1.30 ; 95%-CI 1.24;1.36 , P<0.001 ) . Conclusion Follow-up completeness is a pre-requisite for reliable outcome assessment and should be declared systematic ally . FUI represents a simple measure suited as reporting st and ard . Evidence lacking such information must be challenged as potentially flawed by selection bias Background Esophageal adenocarcinoma ( EA ) is characterized by a strong male predominance . Sex steroid hormones have been hypothesized to underlie this sex disparity , but no population -based study to date has examined this potential association . Methods Using mass spectrometry and ELISA , we quantitated sex steroid hormones and sex hormone binding globulin , respectively , in plasma from males– 172 EA cases and 185 controls – within the Factors Influencing the Barrett/Adenocarcinoma Relationship ( FINBAR ) Study , a case-control investigation conducted in Northern Irel and and Irel and . Multivariable adjusted logistic regression was used to calculate odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) for associations between circulating hormones and EA . Results Higher and rogen : estrogen ratio metrics were associated with increased odds of EA ( e.g. , testosterone : estradiol ratio ORQ4 v. Q1 = 2.58 , 95%CI = 1.23–5.43 ; Ptrend = 0.009 ) . All estrogens and and rogens were associated with significant decreased odds of EA . When restricted to individuals with minimal to no decrease in body mass index , the size of association for the and rogen : estrogen ratio was not greatly altered . Conclusions This first study of sex steroid hormones and EA provides tentative evidence that and rogen : estrogen balance may be a factor related to EA . Replication of these findings in prospect i ve studies is needed to enhance confidence in the causality of this effect Background Synthesis of multiple r and omized controlled trials ( RCTs ) in a systematic review can summarize the effects of individual outcomes and provide numerical answers about the effectiveness of interventions . Filtering of search es is time consuming , and no single method fulfills the principal requirements of speed with accuracy . Automation of systematic review s is driven by a necessity to expedite the availability of current best evidence for policy and clinical decision-making . We developed Rayyan ( http://rayyan.qcri.org ) , a free web and mobile app , that helps expedite the initial screening of abstract s and titles using a process of semi-automation while incorporating a high level of usability . For the beta testing phase , we used two published Cochrane review s in which included studies had been selected manually . Their search es , with 1030 records and 273 records , were uploaded to Rayyan . Different features of Rayyan were tested using these two review s. We also conducted a survey of Rayyan ’s users and collected feedback through a built-in feature . Results Pilot testing of Rayyan focused on usability , accuracy against manual methods , and the added value of the prediction feature . The “ taster ” review ( 273 records ) allowed a quick overview of Rayyan for early comments on usability . The second review ( 1030 records ) required several iterations to identify the previously identified 11 trials . The “ suggestions ” and “ hints , ” based on the “ prediction model , ” appeared as testing progressed beyond five included studies . Post rollout user experiences and a reflexive response by the developers enabled real-time modifications and improvements . The survey respondents reported 40 % average time savings when using Rayyan compared to others tools , with 34 % of the respondents reporting more than 50 % time savings . In addition , around 75 % of the respondents mentioned that screening and labeling studies as well as collaborating on review s to be the two most important features of Rayyan . As of November 2016 , Rayyan users exceed 2000 from over 60 countries conducting hundreds of review s totaling more than 1.6 M citations . Feedback from users , obtained mostly through the app web site and a recent survey , has highlighted the ease in exploration of search es , the time saved , and simplicity in sharing and comparing include-exclude decisions . The strongest features of the app , identified and reported in user feedback , were its ability to help in screening and collaboration as well as the time savings it affords to users . Conclusions Rayyan is responsive and intuitive in use with significant potential to lighten the load of review ers BACKGROUND Contrasting etiologic hypotheses about the role of endogenous sex steroids in breast cancer development among premenopausal women implicate ovarian and rogen excess and progesterone deficiency , estrogen excess , estrogen and progesterone excess , and both an excess or lack of adrenal and rogens ( dehydroepi and rosterone [ DHEA ] or its sulfate [ DHEAS ] ) as risk factors . We conducted a case-control study nested within the European Prospect i ve Investigation into Cancer and Nutrition cohort to examine associations among premenopausal serum concentrations of sex steroids and subsequent breast cancer risk . METHODS Levels of DHEAS , ( Delta4- ) and rostenedione , testosterone , and sex hormone binding globulin ( SHBG ) were measured in single prediagnostic serum sample s from 370 premenopausal women who subsequently developed breast cancer ( case patients ) and from 726 matched cancer-free control subjects . Levels of progesterone , estrone , and estradiol were also measured for the 285 case patients and 555 matched control subjects who had provided information about the day of menstrual cycle at blood donation . Conditional logistic regression models were used to estimate relative risks of breast cancer by quartiles of hormone concentrations . All statistical tests were two-sided . RESULTS Increased risks of breast cancer were associated with elevated serum concentrations of testosterone ( odds ratio [ OR ] for highest versus lowest quartile = 1.73 , 95 % confidence interval [ CI ] = 1.16 to 2.57 ; P(trend ) = .01 ) , and rostenedione ( OR for highest versus lowest quartile = 1.56 , 95 % CI = 1.05 to 2.32 ; P(trend ) = .01 ) , and DHEAS ( OR for highest versus lowest quartile = 1.48 , 95 % CI = 1.02 to 2.14 ; P(trend ) = .10 ) but not SHBG . Elevated serum progesterone concentrations were associated with a statistically significant reduction in breast cancer risk ( OR for highest versus lowest quartile = 0.61 , 95 % CI = 0.38 to 0.98 ; P(trend ) = .06 ) . The absolute risk of breast cancer for women younger than 40 followed up for 10 years was estimated at 2.6 % for those in the highest quartile of serum testosterone versus 1.5 % for those in the lowest quartile ; for the highest and lowest quartiles of progesterone , these estimates were 1.7 % and 2.6 % , respectively . Breast cancer risk was not statistically significantly associated with serum levels of the other hormones . CONCLUSIONS Our results support the hypothesis that elevated blood concentrations of and rogens are associated with an increased risk of breast cancer in premenopausal women OBJECTIVE To evaluate the effect of finasteride on serum and rost-4-ene-3,17-dione ( and rostenedione ) and its association with prostate cancer risk among subjects who participated in the Prostate Cancer Prevention Trial . METHODS We analyzed serum and rostenedione levels in 317 prostate cancer cases and 353 controls , nested in the Prostate Cancer Prevention Trial , a r and omized placebo-controlled trial that found finasteride decreased prostate cancer risk . And rostenedione is the second most important circulating and rogen in men besides testosterone and also a substrate for 5α-reductase enzyme . RESULTS We observed a 22 % increase in and rostenedione levels compared with the baseline values in subjects who were treated with finasteride for 3 years . This significant increase did not vary by
Output:
| Most studies focused on cancer risk prediction , followed by diagnosis , prognosis , and therapy monitoring .
Prostate cancer was the most frequently studied cancer .
Estradiol , dehydroepi and rosterone , and cortisol were mostly reported and altered in at least four types of cancer .
Estrogen and estrogen metabolites were highly reported to associate with women-related cancers .
Pathway enrichment analysis revealed that steroidogenesis ; and rogen and estrogen metabolism ; and and rostenedione metabolism were significantly altered in cancers .
Our findings indicated that estradiol , dehydroepi and rosterone , cortisol , and estrogen metabolites , among others , could be considered oncosteroids . |
MS211636 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective : Perioperative transfusion has adverse effects in adults undergoing cardiac surgery . We sought to investigate whether greater use of blood and blood products might be an independent predictor of prolonged postoperative recovery , indicated by duration of mechanical ventilation ( DMV ) , after reparative infant heart surgery . Design : Secondary analysis of prospect ively collected data from two r and omized trials of hematocrit strategy during cardiopulmonary bypass in infant heart surgery to explore the association of DMV with perioperative transfusion and other variables . Setting : Tertiary pediatric hospital . Patients : Two hundred seventy infants undergoing two ventricle corrective cardiac surgery without aortic arch reconstruction . Measurements and Main Results : In univariable analyses , longer DMV was associated with younger age and lower weight at surgery , diagnostic group , and higher intraoperative and postoperative blood product transfusion ( each p < .001 ) . In multivariable proportional hazard regression , longer total support time and greater intraoperative and early postoperative blood products per kg were the strongest predictors of longer DMV . Patients in the highest tertile of intraoperative blood products per kg had an instantaneous risk of being extubated approximately half that of patients in the lowest tertile ( hazard ratio , 0.51 ; 95 % confidence interval , 0.35 , 0.73 ) . Patients who received any blood products on postoperative day 1 , compared with those who did not , had a hazard ratio for extubation of 0.65 ( 95 % confidence interval , 0.50 , 0.85 ) . Conclusions : In this exploratory secondary analysis of infants undergoing two ventricular repair of congenital heart disease without aortic arch obstruction , greater intraoperative and early postoperative blood transfusion emerged as potential important risk factors for longer DMV . Future prospect i ve clinical trials are needed to determine whether reduction in blood product administration hastens postoperative recovery after infant heart surgery BACKGROUND Fibrinogen supplementation is increasingly recommended with the use of rotational thromboelastometry ( ROTEM ) . However , data regarding the paediatric population are sparse . OBJECTIVE We aim ed to assess the relationship between plasma fibrinogen concentration and postoperative blood loss in children undergoing cardiac surgery . DESIGN Retrospective analysis . SETTING Data prospect ively recorded in our departmental data base between September 2010 and January 2012 . PATIENTS Data from 156 children scheduled for congenital heart surgery with ROTEM performed at the end of cardiopulmonary bypass ( CPB ) were analysed . INTERVENTION None . MAIN OUTCOME MEASURES Abnormal bleeding was defined as blood loss that exceeded 10 % of total blood volume within the first 6 postoperative hours . Logistic regression analyses were used to determine variables associated with bleeding . Correlation analyses and receiver operating characteristic ( ROC ) curves were design ed to evaluate the relationship between blood loss and plasma fibrinogen concentration or ROTEM variables , if relevant . RESULTS Thirty-six children were considered as ‘ bleeders ’ and 120 as ‘ nonbleeders ’ . Univariate and multivariate logistic regression analysis revealed time for wound closure , clot formation time , maximal clot firmness ( MCF ) and plasma fibrinogen concentration as variables independently associated with postoperative bleeding . MCF was best correlated with plasma fibrinogen concentration . ROC curves for blood loss versus fibrinogen concentration and MCF showed that a plasma fibrinogen concentration of 1.5 g l−1 and a MCF value 3 mm or less could be used to predict blood loss . CONCLUSION Post-CPB plasma fibrinogen concentration significantly influences blood loss in children undergoing cardiac surgery . A fibrinogen concentration of at least 1.5 g l−1 or a MCF of at least 3 mm should accurately predict excessive blood loss in cardiac surgery children . Further prospect i ve trials are needed to assess the effect of fibrinogen supplementation on postoperative blood loss in this population BACKGROUND : The inflated costs and documented deleterious effects of excess perioperative transfusion have led to the investigation of targeted coagulation factor replacement strategies . One particular coagulation factor of interest is factor I ( fibrinogen ) . Hypofibrinogenemia is typically tested for using time-consuming st and ard laboratory assays . The thrombelastography (TEG)-based functional fibrinogen level ( FLEV ) provides an assessment of whole blood clot under platelet inhibition to report calculated fibrinogen levels in significantly less time . If FLEV values obtained on cardiopulmonary bypass ( CPB ) during rewarming are similar to values obtained immediately after the discontinuation of CPB , then rewarming values could be used for preemptive ordering of appropriate blood product therapy . METHODS : Fifty-one cardiac surgery patients were enrolled into this prospect i ve nonr and omized study to compare rewarming fibrinogen values with postbypass values using TEG FLEV assays . Baseline , rewarming , and postbypass fibrinogen values were recorded for all patients using both st and ard laboratory assay ( Clauss method ) and FLEV . Mixed-effects regression models were used to examine the change in TEG FLEV values over time . Bl and -Altman analysis was used to examine bias and the limits of agreement ( LOA ) between the st and ard laboratory assay and FLEVs . RESULTS : Forty-nine patients were included in the analysis . The mean FLEV value during rewarming was 333.9 mg/dL compared with 332.8 mg/dL after protamine , corresponding to an estimated difference of −1.1 mg/dL ( 95 % confidence interval [ CI ] , −25.8 to 23.6 ; P = 0.917 ) . Rewarming values were available on average 47 minutes before postprotamine values . Bl and -Altman analysis showed poor agreement between FLEV and st and ard assays : mean difference at baseline was 92.5 mg/dL ( 95 % CI , 71.1 to 114.9 ) , with a lower LOA of −56.5 mg/dL ( 95 % CI , −94.4 to −18.6 ) and upper LOA of 242.4 mg/dL ( 95 % CI , 204.5 to 280.3 ) . The difference between assays increased after CPB and persisted after protamine administration . CONCLUSIONS : Our results revealed negligible change in FLEV values from the rewarming to postbypass periods , with a CI that does not include clinical ly meaningful differences . These findings suggest that rewarming sample s could be utilized for ordering fibrinogen-specific therapies before discontinuation of CPB . Mean FLEV values were consistently higher than the reference st and ard at each time point . Moreover , bias was highly heterogeneous among sample s , implying a large range of potential differences between assays for any 1 patient Background . In newborns and small infants undergoing cardiac surgery with cardiopulmonary bypass ( CPB ) and blood priming , it is unclear whether there is reduced blood loss if fresh frozen plasma ( FFP ) is added to the CPB priming volume . This single‐centre , r and omized trial tested the hypothesis that the administration of FFP after CPB ( late FFP group ) is superior to FFP priming ( early FFP group ) in terms of postoperative bleeding and overall red blood cell ( RBC ) transfusion . Methods . Seventy‐three infants weighing < 10 kg were r and omly allocated to receive FFP to supplement RBCs in the CPB priming solution ( n=36 ) or immediately after CPB ( n=37 ) . The primary endpoint was a difference in postoperative blood loss ; secondary endpoints included the amount of RBCs and FFP transfused through the first 48 postoperative hours . Results . All patients were included in the analysis . Patients in the late FFP arm had greater postoperative mean blood loss than patients in the early FFP arm [ 33.1 ( SD 20.6 ) vs 24.1 ( 12.9 ) ml kg‐1 ; P=0.028 ] , but no differences in transfusions were found . The subgroup of cyanotic heart disease patients had comparable results , but with greater use of RBCs in the late FFP group . Conclusions . In infants undergoing cardiac surgery , FFP in the priming solution appears slightly superior to late administration in terms of postoperative bleeding . Clinical trial registration : www . Clinical Trials.gov , NCT02738190 OBJECTIVES Acute acquired hypofibrinogenemia in children undergoing cardiac surgery is a major concern because it often results in perioperative bleeding and high rates of allogeneic blood transfusion . Fibrinogen concentrate has been proposed as an alternative to cryoprecipitate ( the gold st and ard therapy ) , with minimal infectious and immunologic risks . Our objective was to investigate the efficacy and safety of fibrinogen concentrate in children undergoing cardiac surgery . METHODS In this r and omized pilot study , patients were allocated to receive fibrinogen concentrate ( 60 mg/kg ) or cryoprecipitate ( 10 mL/kg ) if bleeding was associated with fibrinogen levels<1 g/dL after cardiopulmonary bypass weaning . The primary outcome was postoperative blood losses during the 48 hours after surgery . RESULTS A total of 63 patients were included in the study , 30 in the fibrinogen concentrate group and 33 in the cryoprecipitate group . The median 48-hour blood loss was not significantly different between the 2 groups ( 320 mL [ interquartile range , 157 - 750 ] vs 410 mL [ interquartile range , 215 - 510 ] , respectively ; P=.672 ) . After treatment , plasma fibrinogen concentration increased similarly following administration of both products . There were no differences in allogeneic blood transfusion after intervention treatment . CONCLUSIONS A large trial comparing fibrinogen concentrate and cryoprecipitate in the management of children with acute acquired hypofibrinogenemia during heart surgery is feasible . The preliminary results of our study showed that the use of fibrinogen concentrate was as efficient and safe as cryoprecipitate in the management of bleeding children undergoing cardiac surgery OBJECTIVE The present study was conducted to determine how children and adults differ ( it at all ) with respect to sensitivity to heparin activity and heparin-protamine interactions during cardiac surgery requiring cardiopulmonary bypass ( CPB ) . DESIGN A prospect i ve study of both children and adults undergoing CPB . SETTING A tertiary care academic medical center between July 1992 and October 1994 . PARTICIPANTS Ninety patients who had cardiac or aortic arch surgery using CPB . The median age of the entire study sample was 15.8 years ( range 2 months to 72 years ) . INTERVENTION Data were obtained using the Medtronic Hemotec Hepcon Hemostasis Management System ( Englewood , CO ) . An ex vivo heparin dose-response ( HDR ) curve was generated for each patient before skin incision to determine the target heparin concentration ( THC ) needed to achieve an activated coagulation time ( ACT ) of at least 480 seconds . Protamine dose was determined on the basis of whole blood heparin concentration estimated by means of a heparin-protamine titration . MEASUREMENTS AND MAIN RESULTS The study population was divided into four groups based on age : infants ( < 1 year ) , preschool ( 1 to 5 years ) , school-age ( 5 to 14 years ) and adults ( > 14 years ) . The mean + /- SD THC for the preschool group was 4.0 + /- 1.1 ; for infants , 3.3 + /- 0.7 ; for school-age , 3.1 + /- 0.7 ; and for adults , 3.4 + /- 0.7 . The initial dose of heparin needed to achieve this THC ( mean + /- SD ) was significantly higher in infants ( 578 + /- 220 U/kg ) and preschool children ( 477 + /- 159 U/kg ) than in school-age children ( 327 + /- 57 U/kg ) and adults ( 332 + /- 64 U/kg ) . The ratio of protamine to heparin was significantly higher in adults ( 1.4 + /- 0.5 ) and school-age children ( 1.3 + /- 0.6 ) than in infants ( 1.1 + /- 0.7 ) and preschool children ( 1.1 + /- 0.4 ) . CONCLUSIONS Pre-school children are less sensitive to heparin but also display a wider range of sensitivity . The data in this study support the use of 300 U/kg of heparin before CPB in patients > or = 5 years but suggest that heparin requirements may be greater in the younger patient who may require as much as 500 U/kg to achieve what is believed to be an appropriate target heparin concentration for initiating CPB BACKGROUND : The majority of pediatric cardiac surgery patients receive blood transfusions . We hypothesized that the routine use of intraoperative thromboelastometry to guide transfusion decisions would reduce the overall proportion of patients receiving transfusions in pediatric cardiac surgery . METHODS : One hundred pediatric cardiac surgery patients were included in the study . Fifty patients ( study group ) were prospect ively included and compared with 50 procedure- and age-matched control patients ( control group ) . In the study group , thromboelastometry , performed during cardiopulmonary bypass , guided intraoperative transfusions . Intraoperative and postoperative transfusions of pack
Output:
| At present , literature data are too weak to define POCTs as a “ gold st and ard ” for the treatment of perioperative bleeding in pediatric cardiac surgery .
Nevertheless , introduction of POCTs into postoperative algorithms has shown to improve bleeding management , patient outcome , and cost efficiency |
MS211637 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The necessity of tendon interposition for the maintenance of joint space after basal joint resection arthroplasty with ligament reconstruction has not been established . A prospect i ve , r and omized study was performed . In Group I ( nine patients ) , ligament reconstruction was performed to suspend the first metacarpal in addition to placement of a rolled tendon interposition to fill the void created by resection of the trapezium . In Group II ( 11 patients ) , ligament reconstruction alone was performed , with use of a Mitek suture anchor . No tendon interposition was performed . This allowed use of a more limited incision and shorter length of tendon graft . Average followup was 23 months . There was no difference between the two groups in range of motion of the thumb , grip strength , lateral pinch strength , the ability to perform activities of daily living , or subjective satisfaction with the procedure . Two- and three-point pinch strength was statistically significantly greater in Group II . Lateral radiographs of the basal joint at followup , at rest and with pinch , showed maintenance of the joint space , and no difference between the two groups . Tendon interposition is not necessary for maintenance of joint space after basal joint resection arthroplasty if ligament reconstruction is performed Seventy-three thumbs in 67 women with osteoarthritis of the trapeziometacarpal joint were assessed prospect ively . The patients were r and omly allocated for treatment by either trapeziectomy alone ( n = 26 ) or trapeziectomy with tendon interposition ( n = 23 ) or ligament reconstruction ( n = 24 ) . A K-wire was passed through the thumb metacarpal base and across the trapezial space into the distal pole of the scaphoid in all procedures ; this held the base of the metacarpal away from the scaphoid for 4 weeks . St and ard thumb radiographs were used to calculate the trapezial space ratio before surgery and at 1-year follow-up examination . The trapezial space ratio decreased significantly from a preoperative mean of 0.40 ( range , 0.20 - 0.56 ) to a mean of 0.18 ( range , 0.08 - 0.30 ) after trapeziectomy , 0.16 ( range , 0.07 - 0.30 ) after trapeziectomy with tendon interposition , and 0.20 ( range , 0.00 - 0.33 ) after trapeziectomy with ligament reconstruction . There was no significant difference between these 1-year follow-up trapezial space ratios , suggesting that the placement of a K-wire across the trapezial void is as effective as tendon interposition or ligament reconstruction in creating a trapezial space in the short term at least . However , the need to create a trapezial space and maintain thumb length is question ed because the trapezial space height did not correlate with thumb strength at 1-year follow-up examination Forty-three h and s in 41 adults with osteoarthrosis of the trapeziometacarpal joint were allocated r and omly to undergo a trapeziectomy through either an anterior approach or the posterior ( dorsoradial ) approach . Forty h and s were available for review at a median of 33 months postoperatively . The demographic characteristics , severity of disease and pre-operative measurements of the two groups were indistinguishable . Trapeziectomy result ed in significantly improved objective and subjective function in both groups , but the anterior approach group had better outcomes for power , scar tenderness and satisfaction . Scar-related complications were three times more common in the posterior group . Trapeziectomy is a good method of treating osteoarthritis of the thumb base , but outcomes for the anterior approach are equally good or better than with the posterior PURPOSE A new spacer for the trapeziometacarpal joint ( TMC ) based on a biological and tissue-preserving concept for the treatment of TMC osteoarthritis ( OA ) has been evaluated . The purpose was to combine a spacing effect with stabilization of the TMC joint . METHODS Artelon ( Artimplant AB , Sweden ) TMC Spacer is synthesized of a degradable polyurethaneurea ( Artelon ) , which has been shown to be biocompatible over time and currently is used in ligament augmentation procedures . Fibers of the polymer were woven into a T-shaped device in which the vertical portion separates the bone edges of the TMC joint and the horizontal portion stabilizes the joint . Fifteen patients with disabling pain and isolated TMC OA were included in the study . Ten patients received the spacer device and the remaining 5 ( control group ) were treated with a trapezium resection arthroplasty with abductor pollicis longus ( APL ) stabilization . The median ages of the 2 groups were 60 and 59 years , respectively . Pain , strength , stability , and range of motion were measured before and after surgery . Radiographic examination was performed in all patients before and after surgery . At follow-up evaluation 3 years after surgery an unbiased observer evaluated all patients . Biopsy specimens were obtained from 1 patient 6 months after surgery . RESULTS All patients were stable clinical ly without signs of synovitis . In both groups all patients were pain free . The median values for both key pinch and tripod pinch increased compared with before surgery in the spacer group but not in the APL group . The biopsy examinations showed incorporation of the device in the surface of the adjacent bone and the surrounding connective tissue . No signs of foreign-body reaction were seen . CONCLUSIONS This study showed significantly better pinch strength after Artelon TMC Spacer implantation into the TMC joint compared with APL arthroplasty Twenty-six h and s in 26 adults with osteoarthrosis of the thumb trapeziometacarpal joint were r and omised to undergo either trapeziectomy alone ( control ) or with the interposition of porcine dermal collagen xenograft ( Permacol ™ ) . The study was terminated prematurely because of apparent reactions to the implants in six of 13 patients . The collagen interposition group required more frequent review on clinical grounds and were discharged later after surgery . Three of the implants have been removed and histology revealed foreign body reactions in all . There was no difference in thumb movement or power after surgery between the two groups . However , improved grip strength was observed and improved function were reported only in the control group . Permacol patients reported greater pain and were less satisfied with their operations than control patients . We conclude that interposition of Permacol is detrimental to the results of trapeziectomy This r and omized prospect i ve study compared the results of trapeziectomy alone , or combined with tendon interposition or ligament reconstruction in 76 women with basal thumb osteoarthritis . At 3 month and 1 year follow-up the results of the three procedures were indistinguishable in terms of pain relief , h and function and thumb strength . In the short term at least , tendon interposition and ligament reconstruction do not improve the results of trapeziectomy Forty-three patients were r and omly allocated to undergo either trapeziectomy alone ( control ) or with a ligament reconstruction and tendon interposition ( LRTI ) using an abductor pollicis longus tendon slip . The patients were review ed at a median 13 ( range , 7–29 ) months after surgery . The demographic characteristics , severity of disease and pre-operative clinical measurements of the two study groups were indistinguishable but LRTI lengthened the operation by approximately 15 minutes . Both groups expressed equal satisfaction with the operation and there were no significant differences between the two treatment groups . Simple trapeziectomy is an effective operation for osteoarthrosis at the base of the thumb and the addition of a ligament reconstruction was not shown to confer any additional benefit
Output:
| 2 ) Trapeziectomy with ligament reconstruction or trapeziectomy with ligament reconstruction and tendon interposition ( LRTI ) is not superior to any of the other techniques .
In addition , trapeziectomy with LRTI seems associated with a higher complication rate .
( 3 ) Because the studies on thumb carpometacarpal ( CMC ) arthrodesis were of less method ological quality and had inconsistent outcomes , we are not able to conclude whether CMC arthrodesis is superior to any other technique .
4 ) A study on joint replacement showed that total joint prosthesis might have better short-term results compared to trapeziectomy with LRTI .
In addition , there is no evidence that the Artelon spacer is superior to trapeziectomy with LRTI .
We conclude that , at this time , no surgical procedure is proven to be superior to another .
However , based on good results of CMC arthrodesis and total joint prostheses , we postulate that there could be differences between the various surgical procedures . |
MS211638 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Increased central venous pressures have been associated with the development of worsening renal function ( WRF ) , an important marker of prognosis . We sought to determine the incidence and prognostic significance of WRF in pulmonary hypertension patients ( PH ) with isolated right HF . A prospect i ve study of PH clinic patients admitted to hospital for right HF . WRF was defined as a rise in creatinine of 26 μmol/L ( 0.3 mg/dL ) within the first 48 hours of admission . A total of 32 patients were enrolled in this study , 67 % of patients had moderate-severe chronic kidney disease with an eGFR ≤ 60 mL/min and 34 % ( n=11 ) developed WRF during their admission . The mean right atrial pressure was higher in patients with WRF ( 19 ± 7 mm Hg vs 12 ± 6 mm Hg , P=.05 ) . A total of 36 % of patients with WRF died in hospital compared to 5 % in the group that did not develop WRF ( OR for hospital death 13.3 ± 16 , P=.03 ) . The combined endpoint of death or readmission at 6 months was 45 % in the WRF group and 43 % in the group without WRF ( P=.89 ) . Significant renal dysfunction is common in patients with PH and an acute decline in renal function is an important marker of in hospital death and short term mortality in right heart failure Aims : To determine if newer criteria for diagnosing and staging acute kidney injury ( AKI ) during heart failure ( HF ) admission are more predictive of clinical outcomes at 30 days and 1 year than the traditional worsening renal function ( WRF ) definition . Methods : We analyzed prospect ively collected clinical data on 637 HF admissions with 30-day and 1-year follow-up . The incidence , stages , and outcomes of AKI were determined using the following four definitions : KDIGO , RIFLE , AKIN , and WRF ( serum creatinine rise ≥0.3 mg/dl ) . Receiver operating curves were used to compare the predictive ability of each AKI definition for the occurrence of adverse outcomes ( death , rehospitalization , dialysis ) . Results : AKI by any definition occurred in 38.3 % ( 244/637 ) of cases and was associated with an increased incidence of 30-day ( 32.3 vs. 6.9 % , χ2 = 70.1 ; p < 0.001 ) and 1-year adverse outcomes ( 67.5 vs. 31.0 % , χ2 = 81.4 ; p < 0.001 ) . Most importantly , there was a stepwise increase in primary outcome with increasing stages of AKI severity using RIFLE , KDIGO , or AKIN ( p < 0.001 ) . In direct comparison , there were only small differences in predictive abilities between RIFLE and KDIGO and WRF concerning clinical outcomes at 30 days ( AUC 0.76 and 0.74 vs. 0.72 , χ2 = 5.6 ; p = 0.02 ) as well as for KDIGO and WRF at 1 year ( AUC 0.67 vs. 0.65 , χ2 = 4.8 ; p = 0.03 ) . Conclusion : During admission for HF , the benefits of using newer AKI classification systems ( RIFLE , AKIN , KDIGO ) lie with the ability to identify those patients with more severe degrees of AKI who will go on to experience adverse events at 30 days and 1 year . The differences in terms of predictive abilities were only marginal Background Acute kidney injury ( AKI ) increases the risk of death after acute myocardial infa rct ion ( AMI ) . Recently , a new AKI definition was proposed by the Kidney Disease Improving Global Outcomes ( KDIGO ) organization . The aim of the current study was to compare the incidence and the early and late mortality of AKI diagnosed by RIFLE and KDIGO criteria in the first 7 days of hospitalization due to an AMI . Methods and Results In total , 1,050 AMI patients were prospect ively studied . AKI defined by RIFLE and KDIGO occurred in 14.8 % and 36.6 % of patients , respectively . By applying multivariate Cox analysis , AKI was associated with an increased adjusted hazard ratio ( AHR ) for 30-day death of 3.51 ( 95 % confidence interval [ CI ] 2.35–5.25 , p<0.001 ) by RIFLE and 3.99 ( CI 2.59–6.15 , p<0.001 ) by KDIGO and with an AHR for 1-year mortality of 1.84 ( CI 1.12–3.01 , p = 0.016 ) by RIFLE and 2.43 ( CI 1.62–3.62 , p<0.001 ) by KDIGO . The subgroup of patients diagnosed as non-AKI by RIFLE but as AKI by KDIGO criteria had also an increased AHR for death of 2.55 ( 1.52–4.28 ) at 30 days and 2.28 ( CI 1.46–3.54 ) at 1 year ( p<0.001 ) . Conclusions KDIGO criteria detected substantially more AKI patients than RIFLE among AMI patients . Patients diagnosed as AKI by KDIGO but not RIFLE criteria had a significantly higher early and late mortality . In this study KDIGO criteria were more suitable for AKI diagnosis in AMI patients than RIFLE criteria Baseline renal function is a potent independent risk factor for adverse events after acute myocardial infa rct ion ( MI ) . Worsening renal function ( WRF ) has been shown to influence outcomes in the heart failure population , but its impact on cardiovascular risk in the post-MI period has not been well defined . For assessment of the prognostic importance of WRF , 2231 patients who had left ventricular dysfunction and were enrolled in the Survival and Ventricular Enlargement ( SAVE ) trial were studied . Patients were r and omly assigned between 3 and 16 d ( average 11 d ) after acute MI to receive captopril or placebo ; those with a serum creatinine of > 2.5 mg/dl were excluded from SAVE . WRF was defined as an increase in creatinine of > 0.3 mg/dl measured from baseline to 2 wk after r and omization . The predictive value of WRF on cardiovascular morbidity and mortality was examined during 42 mo of follow-up . Paired serum creatinine measurements at baseline and 2 wk were available in 1854 patients . WRF occurred in 223 ( 12.0 % ) patients and was a stronger predictor of death ( hazard ratio [ HR ] 1.46 ; 95 % confidence interval [ CI ] 1.05 to 2.02 ) than baseline creatinine ( HR 1.31 ; 95 % CI 1.01 to 1.70 ) . WRF also showed an increased risk for cardiovascular death ( HR 1.62 ; 95 % CI 1.14 to 2.30 ) and the composite end point ( HR 1.32 ; 95 % CI 1.03 to 1.70 ) . When stratified by treatment , 104 ( 5.7 % ) and 116 ( 6.4 % ) patients with WRF in the placebo and captopril groups had no significant association between treatment group and WRF ( P = 0.38 ) . The risk for death associated with WRF was HR 1.63 ( 95 % CI 1.05 to 2.52 ) in the placebo group compared with HR 1.33 ( 95 % CI 0.81 to 2.21 ) in the captopril group ( P = 0.49 for interaction ) . WRF as early as 2 wk after MI was not uncommon ( 12.0 % ) and was associated with increased mortality in patients without renal dysfunction at baseline . Patients who received captopril did not demonstrate more WRF than patients who received placebo . Monitoring serum creatinine in patients during the first few weeks after MI may help to identify those who are at highest risk and guide effective long-term therapeutic choices Background The role of an impaired estimated glomerular filtration rate ( eGFR ) at hospital admission in the outcome of acute kidney injury ( AKI ) after acute myocardial infa rct ion ( AMI ) has been underreported . The aim of this study was to assess the influence of an admission eGFR<60 mL/min/1.73 m2 on the incidence and early and late mortality of AMI-associated AKI . Methods A prospect i ve study of 828 AMI patients was performed . AKI was defined as a serum creatinine increase of ≥50 % from the time of admission ( RIFLE criteria ) in the first 7 days of hospitalization . Patients were divided into subgroups according to their eGFR upon hospital admission ( MDRD formula , mL/min/1.73 m2 ) and the development of AKI : eGFR≥60 without AKI , eGFR<60 without AKI , eGFR≥60 with AKI and eGFR<60 with AKI . Results Overall , 14.6 % of the patients in this study developed AKI . The admission eGFR had no impact on the incidence of AKI . However , the admission eGFR was associated with the outcome of AMI-associated AKI . The adjusted hazard ratios ( AHR , Cox multivariate analysis ) for 30-day mortality were 2.00 ( 95 % CI 1.11–3.61 ) for eGFR<60 without AKI , 4.76 ( 95 % CI 2.45–9.26 ) for eGFR≥60 with AKI and 6.27 ( 95 % CI 3.20–12.29 ) for eGFR<60 with AKI . Only an admission eGFR of < 60 with AKI was significantly associated with a 30-day to 1-year mortality hazard ( AHR 3.05 , 95 % CI 1.50–6.19 ) . Conclusions AKI development was associated with an increased early mortality hazard in AMI patients with either preserved or impaired admission eGFR . Only the association of impaired admission eGFR and AKI was associated with an increased hazard for late mortality among these patients Introduction The development of acute kidney injury ( AKI ) is associated with poor outcome . The modified RIFLE ( risk , injury , failure , loss of kidney function , and end-stage renal failure ) classification for AKI , which classifies patients with renal replacement therapy needs according to RIFLE failure class , improves the predictive value of AKI in patients undergoing cardiac surgery . Our aim was to assess risk factors for post-operative AKI and the impact of renal function on short- and long-term survival among all AKI subgroups using the modified RIFLE classification . Methods We prospect ively studied 2,940 consecutive cardiosurgical patients between January 2004 and July 2009 . AKI was defined according to the modified RIFLE system . Pre-operative , operative and post-operative variables usually measured on and during admission , which included main outcomes , were recorded together with cardiac surgery scores and ICU scores . These data were evaluated for association with AKI and staging in the different RIFLE groups by means of multivariable analyses . Survival was analyzed via Kaplan-Meier and a risk-adjusted Cox proportional hazards regression model . A complete follow-up ( mean 6.9 ± 4.3 years ) was performed in 2,840 patients up to April 2013 . Results Of those patients studied , 14 % ( n = 409 ) were diagnosed with AKI . We identified one intra-operative ( higher cardiopulmonary bypass time ) and two post-operative ( a longer need for vasoactive drugs and higher arterial lactate 24 hours after admission ) predictors of AKI . The worst outcomes , including in-hospital mortality , were associated with the worst RIFLE class . Kaplan-Meier analysis showed survival of 74.9 % in the RIFLE risk group , 42.9 % in the RIFLE injury group and 22.3 % in the RIFLE failure group ( P < 0.001 ) . Classification at RIFLE injury ( Hazard ratio ( HR ) = 2.347 , 95 % confidence interval ( CI ) 1.122 to 4.907 , P = 0.023 ) and RIFLE failure ( HR = 3.093 , 95 % CI 1.460 to 6.550 , P = 0.003 ) were independent predictors for long-term patient mortality . Conclusions AKI development after cardiac surgery is associated mainly with post-operative variables , which ultimately could lead to a worst RIFLE class . Staging at the RIFLE injury and RIFLE failure class is associated with higher short- and long-term mortality in our population AIMS To determine the prevalence and risk factors for worsening renal function ( WRF ) among patients hospitalized for decompensated heart failure ( HF ) and the association with subsequent re-hospitalization and mortality . METHODS AND RESULTS We prospect ively enrolled 299 patients across eight European countries ( mean
Output:
| Increasing AKI severity was associated with worse outcomes .
The impact of CRS-1 defined by AKI on mortality was greatest in CS patients .
AHF patients experienced the highest occurrence rate of AKI , but the impact on mortality was greatest in CS patients |
MS211639 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background A commonly reported problem with the conduct of multicentre r and omised controlled trials ( RCTs ) is that recruitment is often slower or more difficult than expected , with many trials failing to reach their planned sample size within the timescale and funding originally envisaged . The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies : the UK Medical Research Council ( MRC ) and the Health Technology Assessment ( HTA ) Programme . Methods The cohort of trials was identified from the administrative data bases held by the two funding bodies . 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria . The full scientific applications and subsequent trial reports su bmi tted by the trial teams to the funders provided the principal data sources . Associations between trial characteristics and recruitment success were tested using the Chi-squared test , or Fisher 's exact test where appropriate . Results Less than a third ( 31 % ) of the trials achieved their original recruitment target and half ( 53 % ) were awarded an extension . The proportion achieving targets did not appear to improve over time . The overall start to recruitment was delayed in 47 ( 41 % ) trials and early recruitment problems were identified in 77 ( 63 % ) trials . The inter-relationship between trial features and recruitment success was complex . A variety of strategies were employed to try to increase recruitment , but their success could not be assessed . Conclusion Recruitment problems are complex and challenging . Many of the trials in the cohort experienced recruitment difficulties . Trials often required extended recruitment periods ( sometimes supported by additional funds ) . While this is of continuing concern , success in addressing the trial question may be more important than recruitment alone OBJECTIVE To examine pediatricians ' attitudes toward children 's participation in r and omized controlled trials ( RCTs ) and identify possible barriers to participation . STUDY DESIGN Qualitative analysis of focus group discussion s involving 16 pediatricians and 5 trainees from a pediatric teaching hospital in Australia . Doctors varied in occupation , experience , research activity , age , sex , ethnicity , and parenthood experience . A professional facilitator conducted the semistructured group discussion s. The transcribed audiotapes were analyzed by theme linkage by using the constant comparative method . RESULTS Pediatricians believed parents balanced perceived gains and risks when deciding about trial participation . They thought the child 's condition , parents ' health beliefs and personal attributes , and the doctors ' beliefs and relationship with the investigators influenced parents ' attitudes . Perceived gains included professional benefits for pediatricians , improved patient care , convenience for the families and themselves , and scientific advancement . Perceived risks included inconvenience , inadequate re sources , and potential harms to the patient and doctor-patient relationship . Pediatricians with previous research experience were most knowledgeable about RCTs and perceived greatest gains from trial participation . Pediatricians ' personal treatment preferences hindered trial support . CONCLUSIONS This study suggests that children 's participation in trials will be enhanced by increasing pediatricians ' awareness of RCTs through education and involvement in trials and by improving the gains-risk balance Background One of the most commonly reported problems of r and omised trials is that recruitment is usually slower than expected . Trials will cost more and take longer , thus delaying the use of the results in clinical practice , and incomplete sample s imply decreased statistical power and usefulness of its results . We aim to identify barriers and facilitators for successful patient recruitment at the level of the patient , the doctor and the hospital organization as well as the organization and design of trials over a broad range of studies . Methods / design We will perform two cohort studies and a case-control study in the Netherl and s. The first cohort study will report on a series of multicenter trials performed in a nationwide network of clinical trials in obstetrics and gynaecology . A question naire will be sent to all clinicians recruiting for these trials to identify determinants - aggregated at centre level - for the recruitment rate . In a case control- study nested in this cohort we will interview patients who refused or consented participation to identify factors associated with patients ' consent or refusal . In a second cohort study , we will study trials that were prospect ively registered in the Netherl and s Trial Register . Using a question naire survey we will assess whether issues on hospital organization , trial organization , planning and trial design were associated with successful recruitment , i.e. 80 % of the predefined number of patients recruited within the planned time . Discussion This study will provide insight in barriers and facilitators for successful patient recruitment in trials . The results will be used to provide recommendations and a checklist for individual trialists to identify potential pitfalls for recruitment and judge the feasibility prior to the start of the study . Identified barriers and motivators coupled to evidence -based interventions can improve recruitment of patients in clinical trials Background Qualitative methods are increasingly used to study the process of clinical trials and patients underst and ing of the rationale for trials , r and omisation and reasons for taking part or refusing . Patients ' underst and ings are inevitably influenced by the recruiting clinician 's underst and ing of the trial , yet relatively little qualitative work has explored clinicians ' perceptions and underst and ings of trials . This study interviewed surgeons shortly after the multi-centre , pragmatic RCT in which they had participated had been completed . Methods We used in-depth interviews with surgeons who participated in the Spine Stabilisation Trial ( a pragmatic RCT ) to explore their underst and ing of the trial purpose and how this underst and ing had influenced their recruitment procedures and interpretation of the results . A purposive sample of eleven participating surgeons was chosen from 8 of the 15 UK trial centres . Results Although the surgeons thought that the trial was addressing an important question there was little agreement about what this question was : although it was a trial of ' equivalent ' treatments , some thought that it was a trial of surgery , others a trial of rehabilitation and others that it was exploring what to do with patients in whom all other treatment options had been unsuccessful . The surgeons we interviewed were not aware of the rationale for the pragmatic inclusion criteria and nearly all were completely baffled about the meaning of ' equipoise ' . Misunderst and ings about the entry criteria were an important source of confusion about the results and led to reluctance to apply the results to their own practice . Conclusion The study suggests several lessons for the conduct of future multi-centre trials . Recruiting surgeons ( and other clinicians ) may not be familiar with the rationale for pragmatic design s and may need to be regularly reminded about the purpose during the study . Reassurance may be necessary that a pragmatic design is not considered a design fault . We conclude that it does matter if clinicians do not underst and the rationale for the trial if , as we have shown here , their perception of the trial aims and methods adversely affects who they recruit ; if their views affect what the patients are told ; and if they mistakenly view the results as unscientific , unreliable and ultimately irrelevant to their practice Background Under-recruitment to r and omised controlled trials ( RCTs ) is often problematic and there may be particular difficulties in recruiting patients with severe mental illness . Aim To evaluate reasons for under-recruitment in an RCT of patients with severe mental illness Methods Qualitative study during the recruitment phase of an RCT of supported employment . Trial staff and recruiting clinicians were interviewed . Data were analyzed thematically using constant comparative techniques . Results Recruitment rates were low . Five main reasons for recruitment difficulties were found . These included : ( i ) misconceptions about trials , ( ii ) lack of equipoise , ( iii ) misunderst and ing of the trial arms , ( iv ) variable interpretations of eligibility criteria , ( v ) paternalism . Conclusion Reasons for recruitment difficulties in trials involving patients with severe mental illness include issues that occur in trials in general , but others are more specific to these patients . Clinician and patient involvement in the study design may improve recruitment in future similar trials Background Poor recruitment and retention of participants in r and omised controlled trials ( RCTs ) is problematic but common . Clear and detailed reporting of participant flow is essential to assess the generalisability and comparability of RCTs . Despite improved reporting since the implementation of the CONSORT statement , important problems remain . This paper aims : ( i ) to up date and extend previous review s evaluating reporting of participant recruitment and retention in RCTs ; ( ii ) to quantify the level of participation throughout RCTs . Methods We review ed all reports of RCTs of health care interventions and /or processes with individual r and omisation , published July – December 2004 in six major journals . Short , secondary or interim reports , and Phase I/II trials were excluded . Data recorded were : general RCT details ; inclusion of flow diagram ; participant flow throughout trial ; reasons for non-participation/withdrawal ; target sample sizes . Results 133 reports were review ed . Overall , 79 % included a flow diagram , but over a third were incomplete . The majority reported the flow of participants at each stage of the trial after r and omisation . However , 40 % failed to report the numbers assessed for eligibility . Percentages of participants retained at each stage were high : for example , 90 % of eligible individuals were r and omised , and 93 % of those r and omised were outcome assessed . On average , trials met their sample size targets . However , there were some substantial shortfalls : for example 21 % of trials reporting a sample size calculation failed to achieve adequate numbers at r and omisation , and 48 % at outcome assessment . Reporting of losses to follow up was variable and difficult to interpret . Conclusion The majority of RCTs reported the flow of participants well after r and omisation , although only two-thirds included a complete flow chart and there was great variability over the definition of " lost to follow up " . Reporting of participant eligibility was poor , making assessment s of recruitment practice and external validity difficult . Reporting of participant flow throughout RCTs could be improved by small changes to the CONSORT chart BACKGROUND Failure to recruit adequate numbers of participants represents a major barrier to the completion of r and omized controlled trials in primary care and is associated with substantial opportunity costs . However , uncertainty exists regarding the relative effectiveness of different methods to promote recruitment . OBJECTIVES The purpose of this study was to estimate the proportion of strategies used to promote patient recruitment to r and omized controlled trials in primary care that are evidence based . METHODS Investigators from seven primary care-based clinical trials of dyspepsia management aim ing to recruit a total of 6070 patients participated . Following a survey of trial organization , a Delphi technique was used to reach consensus on levels of evidence on the effectiveness of interventions or organizational characteristics in influencing recruitment . The main outcome measures were the proportions of interventions or organizational characteristics for influencing patient recruitment that are based upon r and omized controlled trials , on convincing non-experimental evidence or meeting neither of these criteria . RESULTS Out of a total of 56 interventions used across the trials , 35 ( 63 % ) were judged as evidence based . Out of a total of 29 organizational characteristics possessed by the trials , five ( 17 % ) were judged as evidence based . Across the seven dyspepsia trials , the presence of ' favourable ' organizational characteristics appeared to be important contributors towards successful recruitment . CONCLUSIONS A wide range of interventions and organizational characteristics with the potential to promote recruitment were used or possessed by seven primary care trials . Many were not evidence based . Our experience suggests that organizational characteristics could be more influential in trial recruitment than the use of specific interventions . Given the costs of primary care-based trials , research ers need more rigorous evidence to inform recruitment strategies Background Trials frequently encounter difficulties in recruitment , but evidence on effective recruitment methods in primary care is sparse . A robust test of recruitment methods involves comparing alternative methods using a r and omized trial , ' nested ' in an ongoing ' host ' trial . There are potential scientific , logistical and ethical obstacles to such studies . Methods Telephone interviews were undertaken with four groups of stakeholders ( funders , principal investigators , trial managers and ethics committee chairs ) to explore their views on the practicality and acceptability of undertaking nested trials of recruitment methods . These semi-structured interviews were transcribed and analysed thematically . Results Twenty people were interviewed . Respondents were familiar with recruitment difficulties in primary care and recognised the case for ' nested ' studies to build an evidence base on effective recruitment strategies . However , enthusiasm for this global aim was tempered by the challenges of implementation . Challenges for host studies included increasing complexity and management burden ; compatibility between the host and nested study ; and the impact of the nested study on trial design and relationships with collaborators . For nested recruitment studies , there were concerns that host study investigators might have strong preferences , limiting the nested study investigators ' control over their research , and also concerns about sample size which might limit statistical power . Nested studies needed to be compatible with the main trial and should be planned from the outset . Good communication and adequate re sources were seen as important . Conclusions Although research on recruitment was welcomed in principle , the issue of which study had control of key decisions emerged as critical . To address this concern , it appeared important to align the interests of both host and nested studies and to reduce the burden of hosting a recruitment trial . These findings should prove useful in devising a programme of research involving nested studies of recruitment interventions OBJECTIVE To compare the performance of community- vs university-based clinical centers in 3 multicenter r and omized clinical trials of intraocular surgery . METHODS Each Submacular Surgery Trials clinical center was classified as a university-based center , if the contract to perform as a center was signed by a university official , or as a community-based center . The 2 groups of centers were compared on performance , assessed cumulatively by the Submacular Surgery Trials Quality Assurance and Monitoring Subcommittee . OUTCOME MEASURES Patient accrual , completion of scheduled examinations , completion of masked vision examinations 2 years after enrollment ( the design ated primary study end point evaluation time ) , timeliness of su bmi ss
Output:
| Effective interventions included the use of qualitative research to identify and overcome barriers to recruitment , reduction of the clinical workload associated with participation in RCTs and the provision of extra training and protected research time .
Meta summary analysis identified the most frequently reported subthemes to be : difficulty communicating trial methods , poor underst and ing of research and priority given to patient well-being .
The most promising intervention was the use of qualitative methods to identify and overcome barriers to clinician recruitment activity .
The meta summary of qualitative findings identified underst and ing and communicating RCT methods as a key target for future interventions to improve recruitment .
Reinforcement of the potential benefits , both for clinicians and for their patients , could also be a successful factor in improving recruitment . |
MS211640 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Therapy with antibiotics influences recovery only in selected cases of COPD exacerbations . We evaluated the efficacy and safety of procalcitonin guidance compared to st and ard therapy with antibiotic prescriptions in patients experiencing exacerbations of COPD . METHODS A total of 208 consecutive patients requiring hospitalization for COPD exacerbation were r and omized at the index exacerbation to procalcitonin-guided or st and ard antibiotic therapy . Patients receiving procalcitonin-guided therapy were treated with antibiotics according to serum procalcitonin levels ; st and ard-therapy patients received antibiotics according to the attending physician . The primary outcome was the antibiotic exposure at the index exacerbation and the subsequent antibiotic requirement for COPD exacerbation within 6 months . Secondary outcomes were clinical recovery , symptom scores , length of hospitalization , ICU stay , death , lung function , exacerbation rate , and time to next exacerbation . RESULTS At the index exacerbation , procalcitonin guidance reduced antibiotic prescription ( 40 % vs 72 % , respectively ; p < 0.0001 ) and antibiotic exposure ( relative risk [ RR ] , 0.56 ; 95 % confidence interval [ CI ] , 0.43 to 0.73 ; p < 0.0001 ) compared to st and ard therapy . Moreover , procalcitonin guidance at the index exacerbation allowed a significant sustained reduction in total antibiotic exposure for up to 6 months ( RR , 0.76 ; 95 % CI , 0.64 to 0.92 ; p = 0.004 ) . Clinical outcome and improvement in FEV(1 ) at 14 days and 6 months did not differ between groups . Within 6 months , the exacerbation rate ( 0.62 vs 0.64 , respectively ) , the rehospitalization rate ( 0.21 vs 0.24 , respectively ) , and mean ( + /- SD ) time to the next exacerbation ( 70.0 + /- 46.1 vs 70.4 + /- 51.9 days , respectively ; p = 0.523 ) were similar in both groups . CONCLUSIONS Procalcitonin guidance for exacerbations of COPD offers a sustained advantage over st and ard therapy in reducing antibiotic use for up to 6 months with a number-needed-to-treat of 3 BACKGROUND Reduced duration of antibiotic treatment might contain the emergence of multidrug-resistant bacteria in intensive care units . We aim ed to establish the effectiveness of an algorithm based on the biomarker procalcitonin to reduce antibiotic exposure in this setting . METHODS In this multicentre , prospect i ve , parallel-group , open-label trial , we used an independent , computer-generated r and omisation sequence to r and omly assign patients in a 1:1 ratio to procalcitonin ( n=311 patients ) or control ( n=319 ) groups ; investigators were masked to assignment before , but not after , r and omisation . For the procalcitonin group , antibiotics were started or stopped based on predefined cut-off ranges of procalcitonin concentrations ; the control group received antibiotics according to present guidelines . Drug selection and the final decision to start or stop antibiotics were at the discretion of the physician . Patients were expected to stay in the intensive care unit for more than 3 days , had suspected bacterial infections , and were aged 18 years or older . Primary endpoints were mortality at days 28 and 60 ( non-inferiority analysis ) , and number of days without antibiotics by day 28 ( superiority analysis ) . Analyses were by intention to treat . The margin of non-inferiority was 10 % . This trial is registered with Clinical Trials.gov , number NCT00472667 . FINDINGS Nine patients were excluded from the study ; 307 patients in the procalcitonin group and 314 in the control group were included in analyses . Mortality of patients in the procalcitonin group seemed to be non-inferior to those in the control group at day 28 ( 21.2 % [ 65/307 ] vs 20.4 % [ 64/314 ] ; absolute difference 0.8 % , 90 % CI -4.6 to 6.2 ) and day 60 ( 30.0 % [ 92/307 ] vs 26.1 % [ 82/314 ] ; 3.8 % , -2.1 to 9.7 ) . Patients in the procalcitonin group had significantly more days without antibiotics than did those in the control group ( 14.3 days [ SD 9.1 ] vs 11.6 days [ SD 8.2 ] ; absolute difference 2.7 days , 95 % CI 1.4 to 4.1 , p<0.0001 ) . INTERPRETATION A procalcitonin-guided strategy to treat suspected bacterial infections in non-surgical patients in intensive care units could reduce antibiotic exposure and selective pressure with no apparent adverse outcomes . FUNDING Assistance Publique-Hôpitaux de Paris , France , and Brahms , Germany CONTEXT In previous smaller trials , a procalcitonin ( PCT ) algorithm reduced antibiotic use in patients with lower respiratory tract infections ( LRTIs ) . OBJECTIVE To examine whether a PCT algorithm can reduce antibiotic exposure without increasing the risk for serious adverse outcomes . DESIGN , SETTING , AND PATIENTS A multicenter , noninferiority , r and omized controlled trial in emergency departments of 6 tertiary care hospitals in Switzerl and with an open intervention of 1359 patients with mostly severe LRTIs r and omized between October 2006 and March 2008 . INTERVENTION Patients were r and omized to administration of antibiotics based on a PCT algorithm with predefined cutoff ranges for initiating or stopping antibiotics ( PCT group ) or according to st and ard guidelines ( control group ) . Serum PCT was measured locally in each hospital and instructions were Web-based . MAIN OUTCOME MEASURES Noninferiority of the composite adverse outcomes of death , intensive care unit admission , disease-specific complications , or recurrent infection requiring antibiotic treatment within 30 days , with a predefined noninferiority boundary of 7.5 % ; and antibiotic exposure and adverse effects from antibiotics . RESULTS The rate of overall adverse outcomes was similar in the PCT and control groups ( 15.4 % [ n = 103 ] vs 18.9 % [ n = 130 ] ; difference , -3.5 % ; 95 % CI , -7.6 % to 0.4 % ) . The mean duration of antibiotics exposure in the PCT vs control groups was lower in all patients ( 5.7 vs 8.7 days ; relative change , -34.8 % ; 95 % CI , -40.3 % to -28.7 % ) and in the subgroups of patients with community-acquired pneumonia ( n = 925 , 7.2 vs 10.7 days ; -32.4 % ; 95 % CI , -37.6 % to -26.9 % ) , exacerbation of chronic obstructive pulmonary disease ( n = 228 , 2.5 vs 5.1 days ; -50.4 % ; 95 % CI , -64.0 % to -34.0 % ) , and acute bronchitis ( n = 151 , 1.0 vs 2.8 days ; -65.0 % ; 95 % CI , -84.7 % to -37.5 % ) . Antibiotic-associated adverse effects were less frequent in the PCT group ( 19.8 % [ n = 133 ] vs 28.1 % [ n = 193 ] ; difference , -8.2 % ; 95 % CI , -12.7 % to -3.7 % ) . CONCLUSION In patients with LRTIs , a strategy of PCT guidance compared with st and ard guidelines result ed in similar rates of adverse outcomes , as well as lower rates of antibiotic exposure and antibiotic-associated adverse effects . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N95122877 RATIONALE In patients with community-acquired pneumonia , guidelines recommend antibiotic treatment for 7 to 21 d. Procalcitonin is elevated in bacterial infections , and its dynamics have prognostic implication s. OBJECTIVE To assess procalcitonin guidance for the initiation and duration of antibiotic therapy in community-acquired pneumonia . METHODS In a r and omized intervention trial , 302 consecutive patients with suspected community-acquired pneumonia were included . Data were assessed at baseline , after 4 , 6 , and 8 d , and after 6 wk . The control group ( n = 151 ) received antibiotics according to usual practice . In the procalcitonin group ( n = 151 ) , antibiotic treatment was based on serum procalcitonin concentrations as follows : strongly discouraged , less than 0.1 microg/L ; discouraged , less than 0.25 microg/L ; encouraged , greater than 0.25 microg/L ; strongly encouraged , greater than 0.5 microg/L. The primary endpoint was antibiotic use ; secondary endpoints were measures of clinical , laboratory , and radiographic outcome . RESULTS At baseline , both groups were similar regarding clinical , laboratory , and microbiology characteristics , and Pneumonia Severity Index . Procalcitonin guidance reduced total antibiotic exposure ( relative risk , 0.52 ; 95 % confidence interval , 0.48 - 0.55 ; p < 0.001 ) , antibiotic prescriptions on admission ( 85 vs. 99 % ; p < 0.001 ) , and antibiotic treatment duration ( median , 5 vs. 12 d ; p < 0.001 ) compared with patients treated according to guidelines . After adjustment for Pneumonia Severity Index , the hazard ratio of antibiotic discontinuation was higher in the procalcitonin group than in the control group ( 3.2 ; 95 % confidence interval , 2.5 to 4.2 ) . Outcome was similar in both groups , with an overall success rate of 83 % . CONCLUSIONS Procalcitonin guidance substantially reduces antibiotic use in community-acquired pneumonia . These findings may have important clinical and public health implication Recent studies have suggested that procalcitonin ( PCT ) is a safe marker for the discrimination between bacterial and viral infection , and that PCT-guided treatment may lead to substantial reductions in antibiotic use . The present objective was to evaluate the effect of a single PCT measurement on antibiotic use in suspected lower respiratory tract infections ( LRTIs ) in a Danish hospital setting . In a r and omized , controlled intervention study , 223 adult patients admitted to the hospital because of suspicion of LRTI were included with 210 patients available for analysis . Patients were r and omized to either PCT-guided treatment or st and ard treatment . Antibiotic treatment duration in the PCT group was based on the serum PCT value at admission . The cut-off point for recommending antibiotic treatment was PCT > or = 0.25 microg/L. Physicians could overrule treatment guidelines . The mean duration of hospital stay was 5.9 days in the PCT group vs. 6.7 days in the control group ( p 0.22 ) . The mean duration of antibiotic treatment during hospitalization in the PCT group was 5.1 days on average , as compared to 6.8 days in the control group ( p 0.007 ) . In a subgroup analysis of chronic obstructive pulmonary disease patients , the mean length of stay was reduced from 7.1 days in the control group to 4.8 days in the PCT group ( p 0.009 ) . It was concluded that the determination of a single PCT value at admission in patients with suspected LRTIs can lead to a reduction in the duration of antibiotic treatment by 25 % without compromising outcome . No effect on the length of hospital stay was found BACKGROUND Acute respiratory tract infections are the most common reason for antibiotic therapy in primary care despite their mainly viral etiology . A laboratory test measuring procalcitonin levels in blood specimens was suggested as a tool to reduce unnecessary prescribing of antibiotics . We consider whether antibiotic therapy guided by procalcitonin reduces the use of antibiotics without increasing the restrictions experienced by patients by more than 1 day . METHODS Fifty-three primary care physicians recruited 458 patients , each patient with an acute respiratory tract infection and , in the physician 's opinion , in need of antibiotics . Patients were central ly r and omized to either a procalcitonin-guided approach to antibiotic therapy or to a st and ard approach . For patients r and omized to procalcitonin-guided therapy , the use of antibiotics was more or less strongly discouraged ( procalcitonin level , < or = 0.1 or < or = 0.25 microg/L , respectively ) or recommended ( procalcitonin level , > 0.25 microg/L ) . Follow-up data were collected at 7 days by treating physicians and at 14 and 28 days by blinded
Output:
| Procalcitonin guidance reduces antibiotic initiation and use among adults with LRTIs with no apparent adverse impact on length of hospital stay or mortality |
MS211641 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective To describe the health-related quality of life ( HRQOL ) burden of cervical dystonia ( CD ) and report on the HRQOL and patient perception of treatment benefits of abobotulinumtoxinA ( Dysport ) . Design The safety and efficacy of a single injection of abobotulinumtoxinA for CD treatment were evaluated in a previously reported international , multicenter , double-blind , r and omised trial . HRQOL measures were assessed in the trial and have not been previously reported . Setting Movement disorder clinics in the USA and Russia . Participants Patients had to have a diagnosis of CD with symptoms for at least 18 months , as well as a total Toronto Western Spasmodic Torticollis Rating Scale ( TWSTRS ) score of at least 30 ; a Severity domain score of at least 15 ; and a Disability domain score of at least 3 . Key exclusion criteria included treatment with botulinum toxin type A ( BoNT-A ) or botulinum toxin type B ( BoNT-B ) within 16 weeks of enrolment . Interventions Patients were r and omised to receive either 500 U abobotulinumtoxinA ( n=55 ) or placebo ( n=61 ) . Primary and secondary outcome measures Efficacy assessment s included TWSTRS total ( primary end point ) and subscale scores at weeks 0 , 4 , 8 , 12 ; a pain visual analogue scale at weeks 0 and 4 ; and HRQOL assessed by the SF-36 Health Survey ( SF-36 ; secondary end point ) at weeks 0 and 8 . Results Patients with CD reported significantly greater impairment for all SF-36 domains relative to US norms . Patients treated with abobotulinumtoxinA reported significantly greater improvements in Physical Functioning , Role Physical , Bodily Pain , General Health and Role Emotional domains than placebo patients ( p≤0.03 for all ) . The TWSTRS was significantly correlated with Physical Functioning , Role Physical and Bodily Pain scores , for those on active treatment . Conclusions CD has a marked impact on HRQOL . Treatment with a single abobotulinumtoxinA injection results in significant improvement in patients ’ HRQOL . Trial registration number The trial is registered at Clinical Trials.gov , numbers NCT00257660 and NCT00288509 The aim of this study was to evaluate the efficacy and safety of intramuscular ( IM ) administration of botulinum toxin type A ( Dysport((R ) ) , Ipsen Biopharm Ltd. ) for the treatment of cervical dystonia ( CD ) and the long-term safety and efficacy of repeated treatments . During the r and omized , double-blind , placebo-controlled phase patients were r and omized to 500 units Dysport ( n = 55 ) or placebo ( n = 61 ) . Efficacy assessment s included the Toronto Western Spasmodic Torticollis Rating Scale ( TWSTRS ) total and subscale scores , visual analogue scale ( VAS ) for pain , subject/investigator 's VAS for symptom assessment s. Patients completing the double-blind treatment could enter an open-label extension phase and receive up to 4 additional Dysport treatments . Dysport produced a significant decrease from baseline in mean ( + /-SE ) TWSTRS total scores compared with placebo at Week 4 ( primary efficacy endpoint ; -15.6 + /- 2.0 vs. -6.7 + /- 2.0 ; p < 0.001 ) with significant improvements sustained to Week 12 ( p = 0.019 ) . Dysport also produced significant improvements in TWSTRS subscale scores , VAS pain scores , and subject/investigator 's VAS symptom assessment s compared to placebo . The mean duration of open-label study participation was 51.9 weeks ( range 3.9 - 94.0 weeks ) . During open-label treatment , all treatment cycles result ed in improvements in mean TWSTRS total and subscale scores at Week 4 post-treatment ; greatest improvement was seen in cycle 1 . The mean duration between treatment cycles was 15 - 17 weeks . Dysport demonstrated a good long-term safety profile ; most adverse events were mild or moderate and typical of the known safety profile of Dysport in this indication . These results confirm that Dysport ( 500 units ) is safe , effective , and well-tolerated in patients with CD We used turns-amplitude analysis of the EMG as a guidance for botulinum toxin ( BT ) treatment in 19 patients with cervical dystonia . At the first examination , muscles showing abnormal activity ( > 100 turns/sec at rest ) were given BT 75 units ( 10 patients ) or placebo ( 9 patients ) . At subsequent examinations , about 6 , 12 and 18 weeks after the start , BT 75 units were given to all hyperactive muscles . Six weeks after the first BT treatment the sternocleidomastoid muscle contralateral to the involuntary head rotation and the ipsilateral and contralateral posterior neck muscles ( PNM ) showed a reduction of involuntary activity , as indicated by reduced turns/sec and mean amplitude at rest . Similar changes were seen when comparing BT treatment with placebo . The reduction was greater in the contralateral sternocleidomastoid muscle than in PNM , suggesting that PNM need higher doses of BT . At maximal voluntary contraction , BT treated muscles showed unchanged turns/sec ( 5/6 tests ) , decreased mean amplitude and increased ratio ( turns/amplitude ) . This may reflect a functional r and om loss of muscle fibres , combined with inability to activate all motor units . A high ( 89 % ) clinical success rate with BT therapy was obtained , and it is concluded that quantitative EMG is a useful tool for the precise identification of hyperactive muscles , for optimal placing of the injection cannula and for unbiased monitoring of the treatment effect OBJECTIVE IncobotulinumtoxinA differs from available formulations in that it does not have accessory proteins . IncobotulinumtoxinA has previously shown non-inferiority to onabotulinumtoxinA for the treatment of CD with a 1:1 dosing regimen . The objective of this study was to compare the safety and efficacy of incobotulinumtoxinA ( 120 U , 240 U ; Merz Pharmaceuticals ) to placebo in subjects with cervical dystonia ( CD ) . METHODS This was a prospect i ve , double-blind , r and omized , placebo-controlled , multicenter clinical trial in botulinum toxin-treated or toxin-naïve CD patients . The primary outcome measure was change from baseline to Week 4 on the Toronto Western Spasmodic Torticollis Rating Scale ( TWSTRS ) Total score . Adverse events ( AEs ) also were evaluated . RESULTS Participants ( N=233 ) were mostly women ( 66 % ) , a mean of 52.8 years old , who had CD for a mean of 51.9 months . Of those , 39 % were toxin-naïve . IncobotulinumtoxinA significantly improved TWSTRS-Total scores from baseline to Week 4 compared to placebo ( placebo=-2.2 ; 120 U=-9.9 , and 240 U=-10.9 ; 240 U vs. placebo p<0.001 and 120 U vs. placebo p<0.001 ) . This effect persisted through to the end of the study . The most frequently reported AEs in the incobotulinumtoxinA groups were dysphagia , neck pain , and muscular weakness which were generally mild . INTERPRETATION IncobotulinumtoxinA ( at doses of 120 U or 240 U ) is a safe and effective treatment for CD in previously-treated as well as toxin-naïve subjects We studied the effect of botulinum toxin injection in 30 patients with torticollis in a double-blind , placebo-controlled , crossover study . A fixed dose of toxin was injected into the contralateral sternocleidomastoid and both trapezius muscles . Clinical improvement was assessed by a rating scale and by patient self-evaluation . Subjective rating noted improvement in some patients , but there was no change in objective measures . The use of larger doses and injection of additional muscles may be necessary to achieve increased efficacy of botulinum toxin in the treatment of torticollis Background To determine whether botulinum toxin treatment history affected the outcomes of a study comparing the safety and efficacy of incobotulinumtoxinA with placebo in subjects with cervical dystonia ( CD ) . Methods This was a prospect i ve , double-blind , r and omized , placebo-controlled , multicenter trial in botulinum toxin-treated or toxin-naïve CD subjects . Subjects received a fixed dose of either 120 U or 240 U of incobotulinumtoxinA or placebo . The primary outcome measure was change from baseline to Week 4 in the Toronto Western Spasmodic Torticollis Rating Scale ( TWSTRS ) total score . Treatment-emergent adverse events ( TEAEs ) were also evaluated . This report represents a subgroup analysis of botulinum toxin-treated or toxin-naïve subjects . Results Participants ( N = 233 ; 38.6 % toxin-naïve ) had a mean age of 52.8 years . IncobotulinumtoxinA significantly improved TWSTRS total scores from baseline to Week 4 in both dose groups versus placebo , and the improvement persisted through the end of the study ( ≤20 weeks ) . Both the previously toxin-treated and toxin-naïve subjects demonstrated significant improvements in TWSTRS total scores at Week 4 compared to baseline . The most frequent TEAEs in the incobotulinumtoxinA groups were dysphagia , neck pain , and muscular weakness , which were generally mild . TEAEs were more common in the 240 U group and toxin-naïve subjects . Discussion Overall , incobotulinumtoxinA was safe and effective in CD , regardless of toxin therapy history . A lower starting dose may be better tolerated among toxin-naïve subjects without sacrificing efficacy BACKGROUND Approved botulinum toxin A products require reconstitution . AbobotulinumtoxinA solution for injection is a ready-to-use liquid formulation of abobotulinumtoxinA. OBJECTIVES The objective of this study was to demonstrate the superior efficacy of abobotulinumtoxinA solution for injection to placebo and to test the noninferior efficacy of abobotulinumtoxinA solution for injection versus abobotulinumtoxinA ( dry formulation ) in cervical dystonia . METHODS This was a phase-3 , multicenter , prospect i ve , double-blind , r and omized , active , and placebo-controlled study ( N = 369 ) . Patients with cervical dystonia were r and omized ( 3:3:1 ) to abobotulinumtoxinA solution for injection 500 U , abobotulinumtoxinA 500 U , or placebo . Following the double-blind phase , patients received abobotulinumtoxinA solution for injection , open-label , for up to 4 cycles . The primary outcome was change from baseline at week 4 of the Toronto Western Spasmodic Torticollis Rating Scale total score . Secondary measures included change from baseline or cycle baseline in Toronto Western Spasmodic Torticollis Rating Scale scores . RESULTS At week 4 , both products were superior to placebo ( Toronto Western Spasmodic Torticollis Rating Scale total score least square mean decrease from baseline , abobotulinumtoxinA solution for injection 500 U -12.5 , abobotulinumtoxinA 500 U -14.0 , placebo -3.9 ; P < .0001 vs placebo ) . The noninferiority limit of 3 points in the Toronto Western Spasmodic Torticollis Rating Scale total score at week 4 was not met for abobotulinumtoxinA solution for injection versus abobotulinumtoxinA. Toronto Western Spasmodic Torticollis Rating Scale total score reductions were maintained for up to 4 cycles of abobotulinumtoxinA solution for injection open-label follow-up treatment . Safety profiles of abobotulinumtoxinA solution for injection and abobotulinumtoxinA were similar , with dysphagia and injection-site pain the most frequent drug-related adverse events . CONCLUSIONS Although the predefined noninferiority criterion was not met , abobotulinumtoxinA solution for injection was similarly effective to freeze-dried abobotulinumtoxinA in reducing Toronto Western Spasmodic Torticollis Rating Scale total scores with a similar safety profile . AbobotulinumtoxinA solution for injection efficacy was maintained with chronic open-label treatment , and this novel formulation may add convenience as well as dosing accuracy to treatment with abobotulinumtoxinA. © 2016 International Parkinson and Movement Disorder Society Typically , botulinum toxin injections for blepharospasm or cervical dystonia ( CD ) are administered at approximately 3-month intervals , reflecting concerns that shorter intervals might increase the risk of adverse events ( AEs ) and development of neutralizing antibodies . These post-hoc analyses investigated flexible incobotulinumtoxinA ( Xeomin ® ) injection intervals ( 6 - 20 weeks ) in patients with blepharospasm or CD . Patients received
Output:
| The primary efficacy outcome was improvement in cervical dystonia-specific impairment .
The primary safety outcome was the proportion of participants with any adverse event .
Treatment with BtA was associated with a decreased risk of participants withdrawing from trials .
We have moderate certainty in the evidence across all of the aforementioned outcomes .We found no evidence supporting the existence of a clear dose-response relationship with BtA , nor a difference between BtA formulations , nor a difference with use of EMG-guided injection .
We have moderate certainty in the evidence that a single BtA treatment session is associated with a significant and clinical ly relevant reduction of cervical dystonia-specific impairment , including severity , disability , and pain , and that it is well tolerated , when compared with placebo .
There is also moderate certainty in the evidence that people treated with BtA are at an increased risk of developing adverse events , most notably dysphagia and diffuse weakness .
There is no evidence from RCTs to allow us to draw definitive conclusions on the optimal treatment intervals and doses , usefulness of guidance techniques for injection , the impact on quality of life , or the duration of treatment effect |
MS211642 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To evaluate the oral health-related quality of life ( OHRQoL ) of children by dental caries and fluorosis status . METHODS A r and om sample of South Australian 8- to 13-year-old children was selected . Caries data were collected from school dental service records to group children by combined deciduous and permanent tooth caries experience . Children were examined for fluorosis using the Thylstrup and Fejerskov ( TF ) Index to form groups by fluorosis scores on maxillary central incisors . Occlusal traits were recorded using the Dental Aesthetic Index . Children and their parents completed the Child Perception Question naire ( CPQ ) and the Parental Perception Question naire ( PPQ ) and a global rating of oral health ( OH ) . OHRQoL indicators , rating OH as Excellent/Very good , and mean overall CPQ/PPQ scores were compared between groups by fluorosis scores and caries experience . Multivariate models were generated for both OH and CPQ/PPQ indicators . RESULTS Two hundred forty-two children ( 43.0 percent ) had 0 decayed , missing , and filled primary and permanent tooth surface ( dmfs/DMFS ) , while 170 ( 23.9 percent ) had 5 + dmfs/DMFS . The prevalence of TF scores 1 , 2 , and 3 were 14.5 , 9.5 , and 1.9 percent , respectively . The proportion of children/parents rating OH as Excellent/Very good was significantly associated with children 's caries experience . That proportion increased when fluorosis severity increased from a TF score of 0 to 2 , but decreased with a TF of 3 . Having low caries experience and better dental appearance were associated with parents ' perception of good OH . Having mild fluorosis and more acceptable appearance were significant factors for children 's perception of good OH . Caries and malocclusion were associated with lower OHRQoL , while having a TF score of 2 was associated with better OHRQoL in multivariate models for overall CPQ/PPQ scores . CONCLUSION Caries and less acceptable appearance showed a negative impact , while mild fluorosis had a positive impact on child and parental Two groups of children , initially in the first and second grade s , chewed , rinsed with , and swallowed an acidulated phosphate-fluoride tablet containing 1 mg of fluoride either once or twice a day in school . A control group of children followed the procedure once a day using a placebo tablet . An evaluation after six years of treatments showed that both the once-a-day and the twice-a-day procedures with fluoride tablets effectively reduced the incidence of dental caries A 6-yr double-blind study was undertaken to compare the caries inhibiting-effectiveness of ( a ) 1 mgF- tablets ( daily at school ) plus fortnightly rinsing at school with 1000 ppmF- ; ( b ) 1 mgF- tablets plus placebo rinsing ; and ( c ) placebo tablets plus 1000 ppmF- rinsing . Participants were aged 4.5 - 5 yr at outset of the trial . At baseline , and annually thereafter , clinical caries and bitewing X-ray examinations were undertaken , hence ethical approval for a negative control was not feasible . Fissure sealant presence was also recorded . Initially , 192 children from predominantly low socio-economic background s were enrolled , and baseline analyses showed no significant differences between groups with respect to primary caries prevalence . After 6 yr , 112 children remained , by which time no significant differences were noted between DMFT and DMFS values for those in the active tablet/active rinse group , as compared to those in the placebo tablet/active rinse group . However , in relation to both indices , in permanent first molars , the effectiveness of the active tablet/placebo rinse regime appeared to be significantly poorer than the placebo tablet/active rinse programme . For the active tablet/active rinse group , the DMFT difference was significantly less than the active tablet/placebo rinse group ( 37.9 % ) , although for the DMFS difference , significance was not achieved . Similar trends were noted when DMFT and DMFS values for all permanent teeth were considered . The occlusal caries prevalence in permanent first molars followed the DMFT pattern , but differences between combined tablet/rinsing children and tablet-only children could be ascribed solely to the effectiveness of sealant presence . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVE To evaluate the caries-inhibiting effect of a fluoride drops program in two kindergartens in Chengdu , Sichuan Province , a fluoride-deficient area . METHODS For 3 years , participating children ingested in school 0.25 mg fluoride daily , in the form of drops for 2 to 3-year-olds and 0.5 mg for children age 3 years and older . These systemic fluoride supplements were made available for over 180 days each year and they were distributed by teachers who maintained attendance records . Annual examinations were conducted for 176 2-year-olds who had used the supplements in the kindergartens and 148 control children . After 3 years , 128 test and 112 control children remained in the study . RESULTS The results demonstrated a marked reduction in dental caries in the control group : test children had 2.21 decayed , missing , or filled teeth (DMFT)-versus 4.32 in the control group , a reduction rate of 48.84 % . The mean DMFT increments over the 3-year period were 1.76 and 3.92 , respectively . Over a 1- to 3-year period of supplement use , the group provided with the fluoride drops had consistently lower caries prevalence than the control group . The differences were statistically significant . CONCLUSIONS This treatment regimen demonstrated an effective caries-inhibiting effect Abstract 705 children took part in a controlled trial in which they were given the vitamin A and D drops routinely supplied by Swedish child-welfare centres with or without a supplement of sodium fluoride . The children were examined by a dentist each year from the age of one to the age of six ( longer in some cases ) . At the third , fourth , fifth , and sixth examinations the mean number of decayed teeth was around 50 % lower in the fluoride group . It is recommended that fluoride be given in vitamin drops where the local fluoride content of drinking-water is below 0.6 p.p.m . Such a scheme could be voluntary . Other advantages would be simplicity and cheapness Summary A clinical study was conducted which included815 children between 18 and 39 months of age residing in three different fluoride-deficient communities . The children received chewable tablets containing vitamins , vitamins plus fluoride , or fluoride alone and were examined for dental caries initially and at 6 month intervals . The findings during the first two years of the 5 year study indicate that a significant reduction in the incidence of dental caries of about 37 per cent was observed after six months in the children ingesting either the fluoride or vitamin-fluoride supplements . This degree of protection increased to about 55 and 63 per cent , respectively , after the children had used the supplement for one and two years . No differences in efficacy were observed between the fluoride and vitamin-fluoride preparations . No toxicity related to the use of fluoride was encountered Two groups of children initially in the first and second grade s chewed , rinsed with , and swallowed an acidulated phosphate-fluoride tablet containing 1 mg of fluoride either once or twice a day in school . A control group of children followed the procedure once a day using a placebo tablet . An interim evaluation after 55 months showed that the children receiving two fluoride tablets daily had a significant reduction in incremental caries on early erupting teeth , which received primarily topical exposure to the fluoride , as well as on late erupting teeth , which received mainly preeruptive , systemic exposure . The findings also suggested that the use of a single fluoride table daily may reduce dental caries , although the presence of a benefit was less definitive than it was for the two-tablet procedure 376 three-year old children were divided into four experimental groups and exposed to different combinations of preventive programs for a period of two years . All the groups were given the same basic prophylactic information . Additionally Group I received fluoride tablets ( FLUDENT ) for daily sucking twice a day plus a placebo dentifrice free of fluoride . Group II was given a fluoride dentifrice containing 0.025 % F , ( ACTA ) . Group III was given a placebo dentifrice plus fluoride varnish ( Duraphat ) twice a year . Group IV a fluoride dentifrice containing 0.025 % F ( ACTA ) plus fluoride varnish ( Duraphat ) twice a year . No statistically significant difference in caries increment during the two experimental years was found between the groups . A tendency to lower caries increment was found in Group IV , i.e. in the children using the low fluoride dentifrice and treated twice a year with fluoride varnish Incremental caries scores were determined after 30 months in this study involving elementary school children who use acidulated phosphate-fluoride tablets containing 1 mg of fluoride either once or twice a day . Two groups of children initially in the first and second grade s chewed , rinsed with , and swallowed an acidulated phosphate-fluoride tablet either once or twice a day in school . A control group of children followed the procedure once a day using a placebo tablet . An interim evaluation after 30 months showed that the children receiving two fluoride tablets daily had a significant reduction in incremental caries on teeth that were present on the base-line examination and that , thus , were exposed only posteruptively to the fluoride Caries reduction and cost benefit after 3 years of sucking fluoride tablets daily at school . A double-blind Children who received a chewable , acidulated phosphatefluoride tablet daily for two school years had a two to one advantage in caries reduction in the teeth erupting during the course of the study when compared to a control group This r and omized , double-blind study tested the caries-preventive efficacy of prenatal fluoride supplementation in 798 children followed until age 5 . Initially , 1,400 women in the first trimester of pregnancy residing in communities served by fluoride-deficient drinking water were r and omly assigned to one of two groups . During the last 6 months of pregnancy the treatment group received 1 mg fluoride daily in the form of a tablet and the control group received a placebo . Both treatment and control subjects were encouraged to use postnatal dietary fluoride supplements . Caries was measured in children at age 3 and 5 while fluorosis was assessed at age 5 . Caries activity was very low in both study groups : 92 % of children remained caries-free in the treatment group and 91 % remained caries-free in the placebo group . Fluorosis was observed in 26 subjects , all classified as very mild . Overall , there were no statistically significant differences in the study groups with respect to caries and fluorosis in deciduous teeth . The study had sufficient power to detect an absolute risk reduction of 5.1 % while only a 1.5 % reduction was observed . These findings do not support the hypothesis that prenatal fluoride has a strong caries-preventive effect
Output:
| All of the five included studies that evaluated the association between use of fluoride supplements and dental fluorosis found that use of the supplements increased the risk of mild-to-moderate fluorosis .
CONCLUSIONS There is weak and inconsistent evidence that the use of fluoride supplements prevents dental caries in primary teeth .
There is evidence that such supplements prevent caries in permanent teeth .
Mild-to-moderate dental fluorosis is a significant side effect . |
MS211643 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Research increasingly supports the conclusion that well- design ed programs delivered over the Internet can produce significant weight loss compared to r and omized controlled conditions . Much less is known about four important issues addressed in this study : ( 1 ) which recruitment methods produce higher eHealth participation rates , ( 2 ) which patient characteristics are related to enrollment , ( 3 ) which characteristics are related to level of user engagement in the program , and ( 4 ) which characteristics are related to continued participation in project assessment s. Methods We recruited overweight members of three health maintenance organizations ( HMOs ) to participate in an entirely Internet-mediated weight loss program developed by HealthMedia , Inc. Two different recruitment methods were used : personal letters from prevention directors in each HMO , and general notices in member newsletters . The personal letters were sent to members diagnosed with diabetes or heart disease and , in one HMO , to a general membership sample in a particular geographic location . Data were collected in the context of a 2 × 2 r and omized controlled trial , with participants assigned to receive or not receive a goal setting intervention and a nutrition education intervention in addition to the basic program . Results A total of 2311 members enrolled . Bivariate analyses on aggregate data revealed that personalized mailings produced higher enrollment rates than member newsletters and that members with diabetes or heart disease were more likely to enroll than those without these diagnoses . In addition , males , those over age 60 , smokers , and those estimated to have higher medical expenses were less likely to enroll ( all P < .001 ) . Males and those in the combined intervention were less likely to engage initially , or to continue to be engaged with their Web program , than other participants . In terms of retention , multiple logistic regressions revealed that enrollees under age 60 ( P < .001 ) and those with higher baseline self-efficacy were less likely to participate in the 12-month follow-up ( P = .03 ) , but with these exceptions , those participating were very similar to those not participating in the follow-up . Conclusions A single personalized mailing increases enrollment in Internet-based weight loss . eHealth programs offer great potential for recruiting large numbers of participants , but they may not reach those at highest risk . Patient characteristics related to each of these important factors may be different , and more comprehensive analyses of determinants of enrollment , engagement , and retention in eHealth programs are needed Background Young adult smokers are a challenging group to engage in smoking cessation interventions . With wide reach and engagement among users , Facebook offers opportunity to engage young people in socially supportive communities for quitting smoking and sustaining abstinence . Objective We developed and tested initial efficacy , engagement , and acceptability of the Tobacco Status Project , a smoking cessation intervention for young adults delivered within Facebook . Methods The intervention was based on the US Public Health Service Clinical Practice Guidelines and the Transtheoretical Model and enrolled participants into study -run 3-month secret Facebook groups matched on readiness to quit smoking . Cigarette smokers ( N=79 ) aged 18 - 25 , who used Facebook on most days , were recruited via Facebook . All participants received the intervention and were r and omized to one of three monetary incentive groups tied to engagement ( commenting in groups ) . Assessment s were completed at baseline , 3- , 6- , and 12-months follow-up . Analyses examined retention , smoking outcomes over 12 months ( 7-day point prevalence abstinence , ≥50 % reduction in cigarettes smoked , quit attempts and strategies used , readiness to quit ) , engagement , and satisfaction with the intervention . Results Retention was 82 % ( 65/79 ) at 6 months and 72 % ( 57/79 ) at 12 months . From baseline to 12-months follow-up , there was a significant increase in the proportion prepared to quit ( 10/79 , 13 % ; 36/79 , 46 % , P<.001 ) . Over a third ( 28/79 , 35 % ) reduced their cigarette consumption by 50 % or greater , and 66 % ( 52/79 ) made at least one 24-hour quit attempt during the study . In an intent-to-treat analysis , 13 % ( 10/79 ) self-reported 7-day abstinence ( 6/79 , 8 % verified biochemically ) at 12-months follow-up . In their quit attempts , 11 % ( 9/79 ) used a nicotine replacement therapy approved by the Food and Drug Administration , while 18 % ( 14/79 ) used an electronic nicotine delivery system to quit ( eg , electronic cigarette ) . A majority ( 48/79 , 61 % ) commented on at least one Facebook post , with more commenting among those with biochemically verified abstinence at 3 months ( P=.036 ) and those r and omized to receive a personal monetary incentive ( P=.015 ) . Over a third of participants ( 28/79 , 35 % ) reported reading most or all of the Facebook posts . Highest acceptability ratings of the intervention were for post ease ( 57/79 , 72 % ) and thinking about what they read ( 52/79 , 66 % ) ; 71 % ( 56/79 ) recommended the program to others . Only 5 participants attended the optional cognitive-behavioral counseling sessions , though their attendance was high ( 6/7 sessions overall ) and the sessions were rated as easy to underst and , useful , and helpful ( all 90 - 100 % agreed ) . Conclusions A Facebook quit smoking intervention is attractive and feasible to deliver , and early efficacy data are encouraging . However , the 1.5-fold greater use of electronic cigarettes over nicotine replacement products for quitting is concerning Background Web-based computer-tailored approaches have the potential to be successful in supporting smoking cessation . However , the potential effects of such approaches for relapse prevention and the value of incorporating action planning strategies to effectively prevent smoking relapse have not been fully explored . The Stay Quit for You ( SQ4U ) study compared two Web-based computer-tailored smoking relapse prevention programs with different types of planning strategies versus a control group . Objectives To assess the efficacy of two Web-based computer-tailored programs in preventing smoking relapse compared with a control group . The action planning ( AP ) program provided tailored feedback at baseline and invited respondents to do 6 preparatory and coping planning assignments ( the first 3 assignments prior to quit date and the final 3 assignments after quit date ) . The action planning plus ( AP+ ) program was an extended version of the AP program that also provided tailored feedback at 11 time points after the quit attempt . Respondents in the control group only filled out question naires . The study also assessed possible dose – response relationships between abstinence and adherence to the programs . Methods The study was a r and omized controlled trial with three conditions : the control group , the AP program , and the AP+ program . Respondents were daily smokers ( N = 2031 ) , aged 18 to 65 years , who were motivated and willing to quit smoking within 1 month . The primary outcome was self-reported continued abstinence 12 months after baseline . Logistic regression analyses were conducted using three sample s : ( 1 ) all respondents as r and omly assigned , ( 2 ) a modified sample that excluded respondents who did not make a quit attempt in conformance with the program protocol , and ( 3 ) a minimum dose sample that also excluded respondents who did not adhere to at least one of the intervention elements . Observed case analyses and conservative analyses were conducted . Results In the observed case analysis of the r and omized sample , abstinence rates were 22 % ( 45/202 ) in the control group versus 33 % ( 63/190 ) in the AP program and 31 % ( 53/174 ) in the AP+ program . The AP program ( odds ratio 1.95 , P = .005 ) and the AP+ program ( odds ratio 1.61 , P = .049 ) were significantly more effective than the control condition . Abstinence rates and effects differed per sample . Finally , the results suggest a dose – response relationship between abstinence and the number of program elements completed by the respondents . Conclusion Despite the differences in results caused by the variation in our analysis approaches , we can conclude that Web-based computer-tailored programs combined with planning strategy assignments and feedback after the quit attempt can be effective in preventing relapse 12 months after baseline . However , adherence to the intervention seems critical for effectiveness . Finally , our results also suggest that more research is needed to assess the optimum intervention dose . Trial Registration Dutch Trial Register : NTR1892 ; http://www.trialregister.nl/trialreg/admin/ rct view.asp?TC=1892 ( Archived by WebCite at http://www.webcitation.org/693S6uuPM Background Dem and for online information and help exceeds most other forms of self-help . Web-assisted tobacco interventions ( WATIs ) offer a potentially low-cost way to reach millions of smokers who wish to quit smoking and to test various forms of online assistance for use/utilization and user satisfaction . Objectives Our primary aim was to determine the utilization of and satisfaction with 2 versions of a smoking cessation website ( smokefree.gov ) , one of which included an asynchronous bulletin board ( BB condition ) . A secondary goal was to measure changes in smoking behavior 3 months after enrollment in the study . Methods All participants were adult federal employees or contractors to the federal government who responded to an email and indicated a willingness to quit smoking in 30 days . We r and omly assigned participants to either the BB condition or the publicly available version — usual care (UC)— and then assessed the number of minutes of website use and satisfaction with each condition as well as changes in smoking behavior . Results Among the 1375 participants , 684 were r and omized to the BB intervention , and 691 to the control UC condition . A total of 39.7 % returned a follow-up question naire after 3 months , with similar rates across the two groups ( UC : n=279 , 40.3 % ; BB : n=267 , 39.0 % ) . Among those respondents assigned to the BB condition , only 81 participants ( 11.8 % ) elected to view the bulletin board or post a message , limiting our ability to analyze the impact of bulletin board use on cessation . Satisfaction with the website was high and did not differ significantly between conditions ( UC : 90.2 % , BB : 84.9 % , P= .08 ) . Utilization , or minutes spent on the website , was significantly longer for the BB than the UC condition ( 18.0 vs 11.1 , P = .01 ) and was nearly double for those who remained in the study ( 21.2 ) than for those lost to follow-up ( 9.6 , P < .001 ) . Similar differences were observed between those who made a serious quit attempt versus those who did not ( 22.4 vs 10.4 , P= .02 ) and between those with a quit date on or a few days prior to the enrollment date versus those with a later quit date ( 29.4 vs 12.5 , P = .001 ) . There were no statistically significant differences in quit rates between the BB and UC group , both in intent-to-treat analysis ( ITT ) and in analyzing the adherence subgroup ( respondents ) only . Combined across the UC and BB groups , 7-day abstinence was 6.8 % with ITT and 17.6 % using only participants in the follow-up ( adherence ) . For participants who attempted to quit within a few days of study entry ( vs 30 days ) , quit rates were 29.6 % ( ITT ) and 44.4 % ( adherence ) . Conclusions Quit rates for participants were similar to other WATIs , with the most favorable outcomes demonstrated by smokers ready to quit at the time of enrolling in the trial and smokers using pharmacotherapy . Utilization of the asynchronous bulletin board was lower than expected , and did not have an impact on outcomes ( quit rates ) . Given the dem and for credible online re sources for smoking cessation , future studies should continue to evaluate use of and satisfaction with Web features and to clarify results in terms of time since last cigarette as well as use of pharmacotherapy . Trial Registration Clinical trials.gov NCT00245076 ; http:// clinical trials.gov/ct2/show/NCT00245076 ( Archived by WebCite at http://www.webcitation.org/5dBuBASA0 Background Effective web-assisted tobacco interventions ( WATIs ) have been underutilized by smokers ; moreover , despite practice guideline recommendations , clinical teams do not routinely refer smokers to WATIs . Our goal was to test a clinical practice innovation , an ePortal design ed to change practice and patient behavior . Our hypotheses were that the integrated system would result in increased smoker referrals , with an automated follow-up system result ing in more smoker registration s and finally augmentations of the WATI would result in more smokers quitting at 6 months . Methods Practice ePortal Implementation Trial : Practice s ( n = 174 ) were r and omized to an online practice ePortal with an “ e-referral tool ” to the WATI ( e-referred smokers received automated email reminders from the practice ) and with practice feedback reports with patient tracking and practice -to-patient secure messaging versus comparison ( a paper “ referral prescription ” ) . Implementation success was measured by the number of smokers referred and smokers registering . Clinical Effectiveness Trial : To estimate the effectiveness of the WATI components on 6-month smoking cessation , registered smokers were r and omized into three groups : a state-of-the-art tailored WATI control [ control ] , the WATI enhanced with proactive , pushed tailored
Output:
| The narrative synthesis demonstrated that tailoring , multimedia delivery of content and reminders are potential techniques for promoting engagement .
The evidence for social support was inconclusive and negative for incentives .
Conclusions This review was the first to examine engagement promoting strategies in solely online substance-use interventions .
Three strategies were identified that may be integral in promoting engagement with online substance-use interventions . |
MS211644 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND To determine the protective effects of memantine on cognitive function in patients receiving whole-brain radiotherapy ( WBRT ) . METHODS Adult patients with brain metastases received WBRT and were r and omized to receive placebo or memantine ( 20 mg/d ) , within 3 days of initiating radiotherapy for 24 weeks . Serial st and ardized tests of cognitive function were performed . RESULTS Of 554 patients who were accrued , 508 were eligible . Grade 3 or 4 toxicities and study compliance were similar in the 2 arms . There was less decline in delayed recall in the memantine arm at 24 weeks ( P = .059 ) , but the difference was not statistically significant , possibly because there were only 149 analyzable patients at 24 weeks , result ing in only 35 % statistical power . The memantine arm had significantly longer time to cognitive decline ( hazard ratio 0.78 , 95 % confidence interval 0.62 - 0.99 , P = .01 ) ; the probability of cognitive function failure at 24 weeks was 53.8 % in the memantine arm and 64.9 % in the placebo arm . Superior results were seen in the memantine arm for executive function at 8 ( P = .008 ) and 16 weeks ( P = .0041 ) and for processing speed ( P = .0137 ) and delayed recognition ( P = .0149 ) at 24 weeks . CONCLUSIONS Memantine was well tolerated and had a toxicity profile very similar to placebo . Although there was less decline in the primary endpoint of delayed recall at 24 weeks , this lacked statistical significance possibly due to significant patient loss . Overall , patients treated with memantine had better cognitive function over time ; specifically , memantine delayed time to cognitive decline and reduced the rate of decline in memory , executive function , and processing speed in patients receiving WBRT . RTOG 0614 , Clinical Trials.gov number CT00566852 PURPOSE To prospect ively evaluate the association between hippocampal dose and long-term neurocognitive function ( NCF ) impairment for benign or low- grade adult brain tumors treated with fractionated stereotactic radiotherapy ( FSRT ) . METHODS AND MATERIAL S Adult patients with benign or low- grade adult brain tumors were treated with FSRT per institutional practice . No attempt was made to spare the hippocampus . NCF testing was conducted at baseline and 18 months follow-up , on a prospect i ve clinical trial . Regression-based st and ardized z scores were calculated by using similar healthy control individuals evaluated at the same test-retest interval . NCF impairment was defined as a z score ≤-1.5 . After delineation of the bilateral hippocampi according to the Radiation Therapy Oncology Group contouring atlas , dose-volume histograms were generated for the left and right hippocampi and for the composite pair . Biologically equivalent doses in 2-Gy fractions ( EQD(2 ) ) assuming an α/β ratio of 2 Gy were computed . Fisher 's exact test and binary logistic regression were used for univariate and multivariate analyses , respectively . Dose-response data were fit to a nonlinear model . RESULTS Of 29 patients enrolled in this trial , 18 completed both baseline and 18-month NCF testing . An EQD(2 ) to 40 % of the bilateral hippocampi > 7.3 Gy was associated with impairment in Wechsler Memory Scale-III Word List ( WMS-WL ) delayed recall ( odds ratio [ OR ] 19.3 ; p = 0.043 ) . The association between WMS-WL delayed recall and EQD(2 ) to 100 % of the bilateral hippocampi > 0.0 Gy trended to significance ( OR 14.8 ; p = 0.068 ) . CONCLUSION EQD(2 ) to 40 % of the bilateral hippocampi greater than 7.3 Gy is associated with long-term impairment in list-learning delayed recall after FSRT for benign or low- grade adult brain tumors . Given that modern intensity-modulated radiotherapy techniques can reduce the dose to the bilateral hippocampi below this dosimetric threshold , patients should be enrolled in ongoing prospect i ve trials of hippocampal sparing during cranial irradiation to confirm these preliminary results The accurate interpretation of serial neuropsychological testing is a fundamental activity of neuropsychologists in clinical and research setting s. Although prior research supports the construct validity of several individual tests for the reliable measurement of cognitive change , neuropsychologists are often interested in detecting changes in cognitive functioning across a battery of tests . In the present study , we examined the specificity of a modified Reliable Change Index ( RCI ) methodology applied across a focused battery of commonly used neuropsychological tests . Fifty-seven healthy controls underwent neuropsychological assessment at two time points separated by approximately 1 year . Test-retest reliability coefficients and st and ard RCI confidence intervals for the individual tests were broadly comparable with prior research in healthy population s. Battery change scores were generated by calculating z-scores of change for each individual test , which were summed across the entire test battery . The RCI methodology was applied to the summed z-score to provide a 90 % confidence interval as an indicator of overall cognitive stability . These battery RCI normative st and ards demonstrated adequate specificity when applied to 29 persons with HIV-1 infection who were classified as medically and neurologically stable . Findings from this study may be useful for both clinicians and research ers seeking normative st and ards for determining reliable changes in performance across a commonly used battery of neuropsychological tests Previous research indicates that practice effects are large with repeated versions of memory tests . In contrast , administrations of the same tests using alternate forms typically yield much smaller practice effects . However , most studies do not compare alternate- and same-form conditions directly , and differ widely in terms of test-retest interval , modality of stimuli ( verbal , spatial ) , format of the memory test , and number of examinations . The present study investigated practice effects during repeated administrations of verbal and nonverbal memory tests which have the same administration format . Two groups of healthy participants , matched for age , education , estimated IQ , and baseline memory test performance , were assigned to either a same- or alternate-forms condition . Participants taking the same form every two weeks improved significantly over four sessions . Participants completing alternate forms of the nonverbal memory test produced a small practice gain , but the verbal memory test was resistant to practice effects when alternate forms were used
Output:
| Conclusions In general , the results show little to no objective cognitive decline up to 4 months after SRS compared with WBRT .
This study is expected to improve the quality of decision-making and maximize clinical outcomes for each individual patient |
MS211645 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: R and omized controlled trials ( RCTs ) are conducted under idealized and rigorously controlled conditions that may compromise their external validity . A literature review was conducted of published English language articles that reported the findings of studies assessing external validity by a comparison of the patient sample included in RCTs reporting on pharmaceutical interventions with patients from everyday clinical practice . The review focused on publications in the fields of cardiology , mental health , and oncology . A range of data bases were interrogated ( MEDLINE ; EMBASE ; Science Citation Index ; Cochrane Methodology Register ) . Double- abstract review and data extraction were performed as per protocol specifications . Out of 5,456 de-duplicated abstract s , 52 studies met the inclusion criteria ( cardiology , n = 20 ; mental health , n = 17 ; oncology , n = 15 ) . Studies either performed an analysis of the baseline characteristics ( demographic , socioeconomic , and clinical parameters ) of RCT -enrolled patients compared with a real-world population , or assessed the proportion of real-world patients who would have been eligible for RCT inclusion following the application of RCT inclusion /exclusion criteria . Many of the included studies concluded that RCT sample s are highly selected and have a lower risk profile than real-world population s , with the frequent exclusion of elderly patients and patients with co-morbidities . Calculation of in eligibility rates in individual studies showed that a high proportion of the general disease population was often excluded from trials . The majority of studies ( n = 37 [ 71.2 % ] ) explicitly concluded that RCT sample s were not broadly representative of real-world patients and that this may limit the external validity of the RCT . Authors made a number of recommendations to improve external validity . Findings from this review indicate that there is a need to improve the external validity of RCTs such that physicians treating patients in real-world setting s have the appropriate evidence on which to base their clinical decisions . This goal could be achieved by trial design modification to include a more representative patient sample and by supplementing RCT evidence with data generated from observational studies . In general , a thoughtful approach to clinical evidence generation is required in which the trade-offs between internal and external validity are considered in a holistic and balanced manner Background Patients with schizophrenia have lower longevity than the general population as a consequence of a combination of risk factors connected to the disease , lifestyle and the use of medications , which are related to weight gain . Methods A multicentric , r and omized , controlled-trial was conducted to test the efficacy of a 12-week group Lifestyle Wellness Program ( LWP ) . The program consists of a one-hour weekly session to discuss topics like dietary choices , lifestyle , physical activity and self-esteem with patients and their relatives . Patients were r and omized into two groups : st and ard care ( SC ) and st and ard care plus intervention ( LWP ) . Primary outcome was defined as the weight and body mass index ( BMI ) . Results 160 patients participated in the study ( 81 in the intervention group and 79 in the SC group ) . On an intent to treat analysis , after three months the patients in the intervention group presented a decrease of 0.48 kg ( CI 95 % -0.65 to 1.13 ) while the st and ard care group showed an increase of 0.48 kg ( CI 95 % 0.13 to 0.83 ; p=0.055 ) . At six-month follow-up , there was a significant weight decrease of −1.15 kg , ( CI 95 % -2.11 to 0.19 ) in the intervention group compared to a weight increase in the st and ard care group ( + 0.5 kg , CI 95 % -0.42–1.42 , p=0.017 ) . Conclusion In conclusion , this was a multicentric r and omized clinical trial with a lifestyle intervention for individuals with schizophrenia , where the intervention group maintained weight and presented a tendency to decrease weight after 6 months . It is reasonable to suppose that lifestyle interventions may be important long-term strategies to avoid the tendency of these individuals to increase weight . Clinical trials.gov Background People with severe mental illnesses ( SMI ) are at increased risk of cardiovascular disease ( CVD ) . Clinical guidelines recommend regular screening for CVD risk factors . We evaluated a nurse led intervention to improve screening rates across the primary - secondary care interface . Methods Six community mental health teams ( CMHTs ) were r and omised to receive either the nurse led intervention plus education pack ( n = 3 ) or education pack only ( n = 3 ) . Intervention ( 6 months ) : The nurse promoted CVD screening in primary care and then in CMHTs . Patients who remained unscreened were offered screening by the nurse . After the intervention participants with SMI were recruited from each CMHT to collect outcome data . Main outcome : Numbers screened during the six months , confirmed in General Practice notes . Results All six CMHTs approached agreed to r and omisation . 121 people with SMI participated in outcome interviews during two waves of recruitment ( intervention arm n = 59 , control arm n = 62 ) . Participants from both arms of the trial had similar demographic profiles and rates of previous CVD screening in the previous year , with less than 20 % having been screened for each risk factor . After the trial , CVD screening had increased in both arms but participants from the intervention arm were significantly more likely to have received screening for blood pressure ( 96 % vs 68 % ; adjusted Odds Ratio ( OR ) 13.6 ; 95 % CI : 3.5 - 38.4 ) , cholesterol ( 66.7 % vs 26.9 % , OR 6.1 ; 3.2 - 11.5 ) , glucose ( 66.7 % vs 36.5 % OR 4.4 ; 2.7 - 7.1 ) , BMI ( 92.5 % vs 65.2 % OR 6.5 ; 2.1 - 19.6 ) , and smoking status ( 88.2 % vs 57.8 % OR 5.5 ; 3.2 - 9.5 ) and have a 10 year CVD risk score calculated ( 38.2 % vs 10.9 % ) OR 5.2 1.8 - 15.3 ) . Within the intervention arm approximately half the screening was performed in general practice and half by the trial nurse . Conclusions The nurse-led intervention was superior , result ing in an absolute increase of approximately 30 % more people with SMI receiving screening for each CVD risk factor . The feasibility of the trial was confirmed in terms of CMHT recruitment and the intervention , but the response rate for outcome collection was disappointing ; possibly a result of the cluster design . The trial was not large or long enough to detect changes in risk factors . Trial Registration International St and ard R and omised Controlled Trial Registration Number ( IS RCT RN ) 58625025 Physical activity is an important aspect of good health for everyone ; it is even more important for psychiatric patients who usually live an unhealthy lifestyle . In recent years , there has been growing focus on the use of soccer as a vehicle to improve the health of subjects with severe mental illness . The aim of this study was to investigate the effects of soccer practice on the self-reported health quality of life ( SRHQL ) and sports performance ( SP ) in psychotic subjects . Eighteen male patients with diagnosis of schizophrenia were r and omized into either a trained ( TG ) or a control group ( CG ) . The TG was trained for 12 weeks using two soccer training sessions per week . The CG did not perform any regular sports activity during the experimental period . Anthropometric measurements , SRHQL , personal time records in a 30 meter sprint test and slalom test running with a ball were evaluated before and after the experimental period . SRHQL was assessed using Short Form-12 question naire measuring physical and mental component summary scores . After the training period , the TG showed a relevant decrease by 4.6 % in bodyweight ( BW ) and body mass index compared to baseline . Conversely , the CG showed an increased BW and body mass index by 1.8 % from baseline to posttest . Moreover , after 12 weeks we found that control patients increased their BW significantly when compared to trained patients ( Δ = 5.4 % ; P < 0.05 ) . After the training period , comparing the baseline TG ’s Short Form-12-scores to posttest results , we found an improvement of 10.5 % and 10.8 % in physical component summary and mental component summary , respectively . In addition , performances on the 30 meter sprint test and slalom test running with a ball in the TG improved significantly ( P < 0.01 ) from baseline to posttest when compared to CG . Soccer practice appears able to improve psychophysical health in individuals with diagnosis of schizophrenia . Indeed , our study demonstrated that programmed soccer physical activity could reduce antipsychotic medication-related weight gain and improve SRHQL and sports performance in psychotic subjects OBJECTIVE Persons with chronic mental disorders are disproportionately burdened with physical health conditions . We determined whether Life Goals Collaborative Care compared to usual care improves physical health in patients with mental disorders within 12 months . METHODS This single-blind r and omized controlled effectiveness study of a collaborative care model was conducted at a midwestern Veterans Affairs urban outpatient mental health clinic . Patients ( N = 293 out of 474 eligible approached ) with an ICD-9-CM diagnosis of schizophrenia , bipolar disorder , or major depressive disorder and at least 1 cardiovascular disease risk factor provided informed consent and were r and omized ( February 24 , 2010 , to April 29 , 2015 ) to Life Goals ( n = 146 ) or usual care ( n = 147 ) . A total of 287 completed baseline assessment s , and 245 completed 12-month follow-up assessment s. Life Goals included 5 weekly sessions that provided semistructured guidance on managing physical and mental health symptoms through healthy behavior changes , augmented by ongoing care coordination . The primary outcome was change in physical health-related quality of life score ( Veterans R AND 12-item Short Form Health Survey [ VR-12 ] physical health component score ) . Secondary outcomes included control of cardiovascular risk factors from baseline to 12 months ( blood pressure , lipids , weight ) , mental health-related quality of life , and mental health symptoms . RESULTS Among patients completing baseline and 12-month outcomes assessment s ( N = 245 ) , the mean age was 55.3 years ( SD = 10.8 ; range , 25 - 78 years ) , and 15.4 % were female . Intent-to-treat analysis revealed that compared to those in usual care , patients r and omized to Life Goals had slightly increased VR-12 physical health scores ( coefficient = 3.21 ; P = .01 ) . CONCLUSIONS Patients with chronic mental disorders and cardiovascular disease risk who received Life Goals had improved physical health-related quality of life . TRIAL REGISTRATION Clinical Trials.gov identifiers : NCT01487668 and NCT01244854 Objective : Weight gain is common for individuals with serious mental illness ( SMI ) receiving antipsychotic drug therapy . Contingency management ( CM ) is a behavioral intervention that rewards positive performance and has demonstrated effectiveness in reducing drug use in SMI population s. This study evaluated the feasibility of using CM to promote weight loss in individuals with SMI over 8 weeks . Method : 30 individuals ( BMI ≥ 28 kg/m2 ) were r and omized to one of three conditions : i ) The combination of a st and ardized lifestyle modification ( LM ) program for individuals with SMI and payment for group attendance ( CMattendance ) , ii ) The combination of LM and payment for weight loss ( CMweight ) , and iii ) waitlist control ( CON ) . After the waitlist period , those participants joined a LM group and received payment for behavioral change ( CMbehavior ) . Results : Subjects in the CMattendance and in the CMweight group lost a mean of 1.16 kg and 1.23 kg , respectively , while subjects in the CON gained a mean of 0.68 kg . Subjects receiving CMbehavior , lost a mean of 2.54 kg , which was a significant weight loss compared to the control period . Conclusion : LM supplemented with CM may facilitate weight loss in patients taking antipsychotic medications ; financial reimbursement for behavioral change may be particularly effective in this population Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Life expectancy in patients with schizophrenia is reduced by 20 years for men and 15 years for women compared to the general population . About 60 % of the excess mortality is due to physical illnesses , with cardiovascular disease being dominant . CHANGE was a r and omized , parallel-group , superiority , multi-centre trial with blinded outcome assessment , testing the efficacy of an intervention aim ed to improve cardiovascular risk profile and hereby potentially reduce mortality . A total of 428 patients with schizophrenia spectrum disorders and abdominal obesity were recruited and central ly r and omized 1:1:1 to 12 months of lifestyle coaching plus care coordination plus treatment as usual ( N=138 ) , or care coordination plus treatment as usual ( N=142 ) , or treatment as usual alone ( N=148 ) . The primary outcome was 10-year risk of cardiovascular disease assessed post-treatment and st and ardized to age 60 . At follow-up , the mean 10-year risk of cardiovascular disease was 8.4 ± 6.7 % in the group receiving lifestyle coaching , 8.5 ±
Output:
| Conclusion : There is a statistically significant , but clinical ly insignificant , mean effect of individualized lifestyle interventions for weight reduction in people with SMI |
MS211646 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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***EXAMPLES***
Input: The present study extends a previous report of lower plasma ACTH levels in women with premenstrual syndrome ( PMS ) compared with asymptomatic controls . Plasma levels of estradiol and progesterone were measured daily in 10 women with confirmed PMS and 8 asymptomatic women . Daily symptom reports were maintained during the same menstrual cycle . Both estradiol and progesterone levels were consistently , but not significantly , higher throughout the cycle in PMS subjects compared with controls . From the follicular to the early luteal phase , estradiol levels were significantly higher in a previously defined PMS subgroup 2 with more severe symptoms throughout the cycle compared with both the less severe PMS subgroup 1 and controls . Progesterone levels were significantly and positively correlated with PMS symptoms along the entire menstrual cycle , preceding the symptoms by 5 - 7 days . These preliminary results provide support for the hypothesis that the presence of progesterone at early luteal phase levels is required for PMS symptoms to occur OBJECTIVES To explore the possible role of natriuretic peptides and vasopressin in luteal phase fluid retention in premenstrual syndrome ( PMS ) and to determine the effect of progesterone therapy on these hormones . DESIGN Self-controlled prospect i ve study . SETTING University-based medical research centre . PATIENTS Six patients with PMS were studied during the symptomatic luteal and asymptomatic follicular phases . The follicular phase response was used as the control for each subject . INTERVENTIONS An intravenous infusion of 3 % saline solution was administered on an early follicular and a late luteal phase day in 2 menstrual cycles . Progesterone was administered orally during the second luteal phase . OUTCOME MEASURES Osmolality , arginine vasopressin ( AVP ) , atrial natriuretic factor ( ANF ) , and brain natriuretic peptide ( BNP ) levels in plasma , osmolality , sodium , potassium , cyclic adenosine monophosphate ( cAMP ) and cyclic guanosine 5'-phosphate ( cGMP ) concentrations in urine , and thirst sensation . RESULTS Mean basal plasma ANF and osmolality levels and the threshold for AVP release and thirst were lower , and mean urinary cyclic nucleotide levels and AVP sensitivity ( amount of AVP secreted per unit rise in plasma osmolality ) were higher , in the luteal phase than in the follicular phase . With saline loading , there was an increase in plasma osmolality , AVP and ANF and in urinary sodium and cyclic nucleotide levels . Plasma ANF and osmolality levels remained lower in the luteal phase compared with the follicular phase , but AVP levels at the end of the saline infusion were higher in the luteal phase than in the follicular phase . Progesterone therapy caused an increase in plasma ANF and osmolality levels and the AVP threshold and a decrease in AVP levels and sensitivity and urinary cyclic nucleotide levels . BNP levels did not change with phase or treatment . The differences in AVP threshold with phase and treatment were statistically significant ( p < 0.001 ) . There was a significant phase effect for plasma ANF ( p = 0.02 ) and a significant or near-significant interaction effect of phase and treatment for plasma ANF ( p = 0.06 ) and urinary cAMP ( p = 0.047 ) and cGMP ( p = 0.066 ) . The effect of phase and treatment was not significant for the other measurements . CONCLUSIONS Luteal phase fluid retention may be due to a relative deficiency of ANF and a lower threshold for AVP release . The symptomatic improvement produced by progesterone treatment may be due to its stimulation of ANF and inhibition of AVP release or synthesis Plasma levels of prolactin , FSH , LH , progesterone and 17–β‐oestradiol in twenty women with premenstrual tension were compared with those in twenty controls . The former group was studied also during treatment with bromocriptine . The mean prolactin level in the PMT group was lower in the follicular phase than in the luteal phase ( P < 0.±01 ) , but there was no difference between the PMT and control group in the luteal phase . No differences were found between the controls and the PMT group in FSH , LH , 17–β‐oestradiol and progesterone levels in the luteal phase . Bromocriptine suppressed prolactin concentrations ( P < 0.±01 ) , but had no effect on the FSH , LH , 17‐B‐oestradiol or progesterone levels Previous studies have indicated that the addition of progestins during sequential hormonal replacement therapy ( HRT ) causes negative mood and physical symptoms . History of premenstrual syndrome , type of progestin , and dose of progestin have thus far been shown to influence the progestin-induced adverse mood symptoms during HRT . The aim of this study was to compare adverse mood effects of two different doses of estradiol , in combination with a progestin , during postmenopausal HRT . Twenty-eight perimenopausal women were included in this r and omized , double-blind , crossover study comparing 2- or 3-mg continuous estradiol , with an addition of 10 mg medroxyprogesterone acetate on d 17 - 28 during each treatment cycle . The main outcome measures were mood and physical symptoms kept on a daily rating scale . Together with the progestin , the higher dose of estrogen caused significantly more negative mood symptoms than the lower dose . Tension , irritability , and depressed mood were all significantly augmented during the progestin phase of cycles with 3 mg estradiol ( P < 0.001 ) . Physical symptoms also increased during the progestin phase of 3-mg estradiol cycles ( P < 0.001 ) , whereas positive mood symptoms were less affected . The only positive mood that changed with estrogen dose was friendliness , which decreased during the progestin phase of high estradiol cycles compared with cycles with lower estradiol ( P < 0.05 ) . Our conclusion is that an increase of the estrogen dose accentuates negative mood and physical symptoms during the progestin phase of sequential hormonal therapy OBJECTIVE This study characterizes the responses to placebo medication of patients with premenstrual syndrome ( PMS ) who were r and omly assigned in controlled treatment trials . Possible predictors of placebo response were also examined . METHOD Subjects from two r and omized controlled trials were pooled . The 101 subjects met defined criteria for severe PMS , remained eligible after 1 month of single-blind placebo lead-in treatment , and were r and omly assigned to 3 months of double-blind placebo treatment . Improvement in the current study was defined as a decrease of at least 50 % in premenstrual symptom score from the pretreatment baseline . RESULTS At endpoint , 20 ( 20 % ) of the placebo-treated subjects showed sustained improvement , 18 of these in at least 3 of the 4 months of placebo medication . Another 42 % of subjects partially improved , and 39 % were clearly unimproved throughout the study period . CONCLUSIONS Some patients with severe PMS experience significant and sustained improvement with placebo medication , but the majority report only partial or no improvement . Patients who sustain improvement for at least 2 consecutive months are likely to remain improved , indicating the importance of nondrug factors in clinical care OBJECTIVE To explore the pulsatile-release characteristics of LH and P in women with premenstrual syndrome ( PMS ) compared with age-matched phase-matched controls . DESIGN Prospect i ve , repeated measures , two-group study . SETTING Human volunteers in an academic research environment . PARTICIPANTS Six women with rigorously defined prospect ively determined PMS ; six age-matched phase-matched controls . MAIN OUTCOME MEASURES Frequency , amplitude , concentration , and coincident pulsatile release characteristics of LH and P at three symptom-related points of the luteal phase . RESULTS No significant between-group differences in frequency , amplitude , or concentration were found . In pooled data , significant coincident pulsing between LH and P was demonstrated . The length of time between LH and P pulses systematic ally increased across the luteal phase , a finding not previously reported . In the PMS group only , significant coincident pulsing occurred at an unexpected zero time lag on the symptom-onset sampling day . CONCLUSION A progressively increasing coupling interval may reflect the gradual decline of the corpus luteum . Presence of a zero time lag between LH and P at symptom onset in women with PMS may indicate an aberrance in corpus luteum response to LH stimulation Some studies suggest that patients suffering from premenstrual syndrome ( PMS ) may be affected by an endogenous opioid dysfunction . Since opioids are the main modulators of the pulsatile LH secretion , we evaluated plasma LH pulsatility in 13 patients with PMS ( aged 33.1 yr ) and in six asymptomatic control volunteers ( aged 31.5 yr ) , in the late luteal phase ( -7 , -5 days before their next menses ) . The patients were prospect ively evaluated for two menstrual cycles with the Menstrual Distress Question naire ; the main symptoms which worsened during the premenstrual period were mood swings and water retention . The pulsatility of plasma LH secretion was studied by collecting blood sample s every 10 min for 12 hr , starting at 0800h . The presence of LH pulses was estimated using the program DETECT on the raw data . This program also allows the computation of the instantaneous secretory rate ( ISR ) . Ovulation was ascertained in all the controls and in nine PMS patients by means of urinary LH assay and luteal progesterone ( P ) determination . The remaining four patients did not ovulate . Both the ovulatory and the anovulatory PMS patients had an increased number of LH pulses/12 hr ( 10.3 + /- 2.4 and 11.5 + /- 4.4 , mean + /- SD , respectively ) in comparison with the controls ( 7.0 + /- 1.3 pulses , p less than 0.01 ) , together with a reduced amplitude and duration . Similar findings were obtained with the ISR computation . Plasma P levels were similar in both the ovulatory patients and controls . The increased frequency and reduced amplitude of LH pulses in the PMS patients most likely reflect a dysfunction of hypothalamic Gn-RH release , possibly linked to a reduction of opioid inhibition This essay traces the history of premenstrual syndrome ( PMS ) in French , British , and American medical literature from 1950 to 2004 . Aetiological theories , treatments and diagnostic criteria have varied over time and place , reflecting local conditions and changing notions of objectivity and evidence . During the 1970s research ers in each nation utilised different research strategies to overcome variation and contradictory results characteristic of PMS research . Since the 1980s , attempts have been made to st and ardise research internationally through prospect i ve daily rating question naires that diagnose and measure PMS . Amidst controversy , a psychiatric reformulation of the syndrome was included in the Diagnostic and Statistical Manual of Mental Disorders ( DSM ) . While the diagnostic criteria for this psychiatric category , now called premenstrual dysphoric disorder ( PMDD ) , are widely accepted for research purpose s , efforts to transfer them to medical practice have been less successful . PMDD remains a contested disease construct A review of measures of menstrual cycle symptoms is provided . This will enable research ers and clinicians to make the appropriate choice of method for their study requirements . In recent years , these measures have taken the form of retrospective question naires ( rating severity of symptoms from memory ) and prospect i ve diaries ( daily checklists of symptoms ) . Many of these draw on aspects of the well-known retrospective question naires , the Menstrual Distress Question naire and Premenstrual Assessment Form , in their development and validation . Each measure will be briefly described , followed by comments on its development , psychometric properties and finally an evaluation of its strengths and weaknesses . It concludes with an examination of the implication s arising from the review , and some recommendations that menstrual cycle research ers and clinicians may wish to consider , as they decide upon the most appropriate measure for their needs The present study evaluates the luteal progesterone ( P ) and LH secretions in 14 patients affected by premenstrual syndrome ( PMS ) and in 14 asymptomatic controls through the evaluation of their episodic release . PMS was prospect ively confirmed in two consecutive menstrual cycles using Moos ' Menstrual Distress Question naire . A pulsatility study was performed during the luteal phase . Blood sample s were drawn every 10 min for 12 h , beginning at 0800 h. Statistically significant pulses were detected using the Detect program , and the degree of concordance of LH and P pulses was estimated . Similar mean 12-h P levels were found in controls ( mean + /- SD , 13.9 + /- 9.3 nmol/L ) and patients ( 14.2 + /- 10.1 ) . LH levels were also similar in the two groups . Patients showed a higher P pulse frequency ( 13.4 + /- 1.8 vs. 11.4 + /- 2.3 ; P < 0.02 ) and a reduced amplitude of secretory episodes ( 126.5 + /- 61.6 % vs. 187.1 + /- 126.7 % ; P < 0.03 ) than controls . Similarly , PMS patients showed pulsatile LH release of increased frequency and reduced amplitude than controls . A significant degree of concordance between LH and P pulses was observed in both groups , with a time lag of 0 - 10
Output:
| The trials did not show that progesterone is an effective treatment for PMS nor that it is not .
Neither trial distinguished a subgroup of women who benefited , nor examined cl aim ed success with high doses |
MS211647 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Introduction The aim of the present prospect i ve multicenter cohort study was to examine the prevalence of sleep disturbance and its relation to the patient 's reported health-related quality of life after intensive care . We also assessed the possible underlying causes of sleep disturbance , including factors related to the critical illness . Methods Between August 2000 and November 2003 we included 1,625 consecutive patients older than 17 years of age admitted for more than 24 hours to combined medical and surgical intensive care units ( ICUs ) at three hospitals in Sweden . Conventional intensive care variables were prospect ively recorded in the unit data base . Six months and 12 months after discharge from hospital , sleep disturbances and the health-related quality of life were evaluated using the Basic Nordic Sleep Question naire and the Medical Outcomes Study 36-item Short-form Health Survey , respectively . As a nonvali date d single-item assessment , the quality of sleep prior to the ICU period was measured . As a reference group , a r and om sample ( n = 10,000 ) of the main intake area of the hospitals was used . Results The prevalence of self-reported quality of sleep did not change from the pre-ICU period to the post-ICU period . Intensive care patients reported significantly more sleep disturbances than the reference group ( P < 0.01 ) . At both 6 and 12 months , the main factor that affected sleep in the former hospitalised patients with an ICU stay was concurrent disease . No effects were related to the ICU period , such as the Acute Physiology and Chronic Health Evaluation score , the length of stay or the treatment diagnosis . There were minor correlations between the rate and extent of sleep disturbance and the health-related quality of life . Conclusion There is little change in the long-term quality of sleep patterns among hospitalised patients with an ICU stay . This applies both to the comparison before and after critical care as well as between 6 and 12 months after the ICU stay . Furthermore , sleep disturbances for this group are common . Concurrent disease was found to be most important as an underlying cause , which emphasises that it is essential to include assessment of concurrent disease in sleep-related research in this group of patients AIM AND OBJECTIVE The study compared the effect of earplug-delivered sleep-inducing music on sleep in persons with percutaneous transluminal coronary angiography in the cardiac care unit . BACKGROUND Diverse types of music have been cl aim ed to improve sleeping elsewhere , but relatively little is known in South Korea . Most studies investigating the effect of sleep-inducing music on sleep have involved persons with insomnia , even though many persons with cardiovascular disease in the intensive care unit suffer from sleeping problems . There is a need to investigate the effect of sleep-inducing music on sleep disorders in persons with percutaneous transluminal coronary angiography in the cardiac care unit . DESIGN An experimental research design was used . METHODS Data collection was conducted in the cardiac care unit of K University Hospital in D city , from 3 September-4 October 2010 . Fifty-eight subjects participated and were r and omly assigned to the experimental group ( earplug-delivered sleep-inducing music for 52 min beginning at 10:00 pm , while wearing an eyeshield , n = 29 ) and the control group ( no music , but earplugs and eyeshield worn , n = 29 ) . The quantity and quality of sleep were measured using question naires at 7 am the next morning for each group . RESULTS Participants in the experimental group reported that the sleeping quantity and quality were significantly higher than control group ( t = 3·181 , p = 0·002 , t = 5·269 , p < 0·001 , respectively ) . CONCLUSION Sleep-inducing music significantly improved sleep in patients with percutaneous transluminal coronary angiography at a cardiac care unit . Offering earplugs and playing sleep-inducing music may be a meaningful and easily enacted nursing intervention to improve sleep for intensive care unit patients . RELEVANCE TO CLINICAL PRACTICE Nurses working at cardiac care unit can use music to improve sleeping in clients with percutaneous transluminal coronary angiography OBJECTIVE To test the efficacy of music and muscle relaxation techniques in reducing the anxiety of patients admitted to a coronary care unit with ischemic heart disease . DESIGN R and omized , controlled trial . SETTING Seven-bed coronary care unit of an Australian tertiary care hospital . PATIENTS Fifty-six patients admitted to a coronary care unit with unstable angina pectoris or acute myocardial infa rct ion . OUTCOME MEASURES Psychologic ( State Trait Anxiety Inventory , Hospital Anxiety and Depression Scale , Linear Analogue Anxiety Scale ) and physiologic ( systolic and diastolic blood pressure and heart rate ) variables were measured as indicators of anxiety . INTERVENTION Two or three 30-minute sessions of audiotape interventions were conducted with portable tape players with headphones . The two intervention tapes consisted of light classical music and verbal instructions for muscle relaxation . RESULTS With analysis of variance procedures , the null hypotheses were supported . No significant differences ( p < 0.05 ) between groups were demonstrated for the psychologic or physiologic variables ; that is , no significant reductions in anxiety were achieved for patients using music or muscle relaxation interventions when compared with the control group . The effect size of the interventions on the outcome measures was 0.19 to 0.22 , indicating a small effect . Result ant power was at a low level . CONCLUSIONS These results differ from those of similar studies but may be related to the high probability of a type II error . Further investigation with longer intervention sessions and larger sample sizes is indicated . Similar studies should incorporate power analysis when reporting their results Objectives : To compare the influence of three ventilatory modes on sleep . Design : Prospect i ve , comparative , crossover study . Setting : Medical intensive care unit in a university hospital . Patients : Fifteen conscious , nonse date d , mechanically ventilated patients . Interventions : Patients were successively ventilated with assist-control ventilation , clinical ly adjusted pressure support ventilation ( cPSV ) , and automatically adjusted pressure support ventilation ( aPSV ) . Sleep polysomnography was performed during three consecutive 6-hr periods , one with each mode in r and om order . Airway pressure and thorax and abdomen plethysmography were used to diagnose central apneas and ineffective efforts . Measurements and Main Results : The main abnormalities were a low percentage of rapid eye movement ( REM ) sleep counting , for a median ( 25th–75th percentiles ) of 10 % ( 3.5–12.5 ) of total sleep , and a highly fragmented sleep with 29 arousals and awakenings per hour of sleep . REM sleep duration was similar in the three ventilatory modes , 7 % in assist-control , 4 % in aPSV , and 1 % during cPSV ( p = .54 ) , as well as in the fragmentation index , 31 arousals and awakenings per hour in assist-control , 32 in aPSV , and 34 during cPSV ( p = .62 ) . Ineffective efforts occurred similarly with the three modes ( seven per hour of sleep in assist-control , 16 in aPSV , and 12 during cPSV ) or central apneas during PSV ( five in aPSV , seven during cPSV ) . Minute ventilation was similar with the three modes . Conclusions : In conscious , mechanically ventilated patients , sleep architecture was highly abnormal , with a short REM stage and a high degree of fragmentation . The ventilatory mode did not influence sleep pattern , arousals , awakenings , and ineffective efforts PURPOSE The purpose of this research was to analyze the effects of an eye protective device and ear protective device application on sleep disorder with coronary disease patients in CCU . METHODS The research design was set up as a nonequivalent control group non-synchronized design . The subjects were coronary disease patients in the CCU of a tertiary hospital . The subjects were composed of 20 in the group with an eye protective device , 18 in the group with an ear protective device , 17 in the group with an eye protective device and ear protective device and 20 in the control group . The data was analyzed by chi2-test , ANOVA , Repeated measures ANOVA , Sheffe-test , Simple main effect and Time contrast using SPSS Win 12.0 . RESULTS The hypothesis , ' There are significant differences in sleep quantity among the four groups ' was supported ( F=1,342.71 , p=.000 ) . The hypothesis , ' There are significant differences in the subjective evaluation of the general sleep patterns among the four groups ' was supported ( F=3,638.73 , p=.000 ) . In addition the hypothesis , ' There are significant differences in degree of sleep among the four groups ' was supported ( F=1,616.61 , p=.000 ) . CONCLUSION It is cost effective and a simple eye protective device and ear protective device should be applied to patients according to their preference and characteristics in the clinical setting BACKGROUND Post-anaesthesia care units ( PACUs ) with 24/7 activity and consequently artificial light and noise may disturb the sleep of patients who require prolonged medical supervision . After one postoperative night , we compared sleep quality in patients with and without noise ( earplug ) and light ( eye mask ) protection . METHODS After ethical board approval , 46 patients without any neurological or respiratory failure undergoing major non-cardiac surgery were prospect ively included . They were r and omized to sleep with or without protective devices during the first postoperative night in the PACU . Sleep quality was simultaneously measured by sleep- quality scales ( Spiegel score and Medical Outcomes Study Sleep ) , nurses ' assessment , and through a wrist actigraph ( Actiwatch ) . Secondary outcomes such as pain control and nocturnal activity were recorded . Comparisons between groups were made by Student 's t-test or non-parametric test for repeated measures as appropriate ( SPSS 10.0 ) . A P-value < 0.05 was considered significant . RESULTS Data from 41 patients were analysed . Protective devices during the first postoperative night prevented a decrease in sleep quality compared with st and ard care , as evaluated by the Spiegel scale : 20 ( 4 ) vs 15 ( 5 ) , P=0.006 . These devices significantly decreased the need for a nap [ 50 % 95 % confidence interval ( CI ) ( 20 - 80 ) vs 95 % 95 % CI ( 85 - 100 ) , P<0.001 ] , but had no effect on sleep length evaluated by Actiwatch . The total consumption of morphine was significantly reduced in the first 24 h [ respectively , 15(12 ) mg and 27(17 ) mg , P=0.02 ] . CONCLUSIONS Earplugs and eye masks applied in the PACU during the first postoperative night significantly preserve sleep quality . Such non-invasive and cheap devices may be generalized in the PACU or in intensive care units The efficacy of complementary and alternative therapies for sleep promotion in critically ill patients is largely unexamined . We found only seven studies ( three on environmental interventions and one each on massage , music therapy , therapeutic touch , and , melatonin ) that examined the effect of complementary and alternative therapies . A number of studies , however , have shown that massage , music therapy . and therapeutic touch promote relaxation and comfort in critically ill patients , which likely leads to improved sleep . Massage , music therapy , and therapeutic touch are safe for critically ill patients and should be routinely applied by ICU nurses who have received training on how to administer these specialized interventions . Environmental interventions , such as reducing noise , playing white noise such as ocean sounds , and decreasing interruptions to sleep for care , also are safe and logical interventions that ICU nurses should use to help patients sleep . Progressive muscle relaxation has been extensively studied and shown to be efficacious for improving sleep in persons with insomnia ; however , progressive muscle relaxation requires that patients consciously attend to relaxing specific muscle groups and practice these techniques , which may be difficult for critically 11 patients . We do not currently recommend aromatherapy and alternative sedatives , such as valerian and melatonin , for sleep promotion in critically ill patients because the safety of these substances is unclear . In summary , we recommend that ICU nurses implement music therapy , environmental interventions , therapeutic touch , and relaxing massage to promote sleep in critically ill patients . These interventions are safe and may improve patient sleep , although r and omized controlled trials are needed to test their efficacy . Aromatherapy and alternative sedatives require further investigation to determine their safety and efficacy Introduction This study hypothesised that a reduction of sound during the night using earplugs could be beneficial in the prevention of intensive care delirium . Two research questions were formulated . First , does the use of earplugs during the night reduce the onset of delirium or confusion in the ICU ? Second , does the use of earplugs during the night improve the quality of sleep in the ICU ? Methods A r and omized clinical trial included adult intensive care patients in an intervention group of 69 patients sleeping with earplugs during the night and a control group of 67 patients sleeping without earplugs during the night . The research ers were blinded during data collection . Assignment was performed by an independent nurse research er using a computer program . Eligible patients had an expected length of stay in the ICU of more than 24 hours , were Dutch- or English-speaking and scored a minimum Glasgow Coma Scale of 10 . Delirium was assessed using the vali date d NEECHAM scale , sleep perception was reported by the patient in response to five questions . Results The use of earplugs during the night lowered the incidence of confusion in the studied intensive care patients . A vast improvement was shown by a Hazard Ratio of 0.47 ( 95 % confidence interval ( CI ) 0.27 to 0.82 ) . Also , patients sleeping with earplugs developed confusion later than the patients sleeping without earplugs
Output:
| No studies examined the effect of any non-pharmacological intervention on mortality , risk of post-traumatic stress disorder , or cost-effectiveness ; the included studies did not clearly report adverse effects , although there was very low quality evidence that ventilator mode influenced the incidence of central apnoeas and patient-ventilator asynchronies . |
MS211648 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE Screening practice s for prostate cancer have result ed in an increasing incidence of prostate cancers . Our knowledge about which prostate cancers are life threatening and which are not is limited . Thus , for ethical , medical , and economic reasons we need to define which patients can be managed by active surveillance . METHODS From 1993 through 1999 , men from the Rotterdam section of the European R and omized study of Screening for Prostate Cancer ( ERSPC ) were screened by two strict protocol s , which were based on prostate-specific antigen ( PSA ) , digital rectal examination , and transrectal ultrasound . For this study , men with criteria that reflect current active surveillance studies were selected : those with a biopsy Gleason score < or = 3 + 3 in two or fewer cores , with a PSA density < 0.2 and a maximum PSA-level of 15 ng/ml . Clinical stage had to be T1C or T2 . RESULTS Of the 1,014 prostate cancers detected in the prevalence screen , 293 men ( 28.9 % ) met the criteria for active surveillance . Their mean age was 65.7 and the mean PSA level was 4.8 ng/ml . Radical prostatectomy was elected by 136 men ( 46.4 % ) , radiotherapy by 91 ( 31.1 % ) , and watchful waiting by 64 ( 21.8 % ) . The mean follow-up was 80.8 months . The eight-year prostate cancer-specific survival was 99.2 % ; the overall survival was 85.4 % . Nineteen men who chose watchful waiting changed to definitive treatment during follow-up . CONCLUSION Only three men died of prostate cancer , none of whom were on watchful waiting . Our observations provide preliminary validation of the arbitrary selection criteria for active surveillance OBJECTIVES To compare the impact that the number of biopsy cores have on final pathologic findings when minimal disease is detected at biopsy . Discordance has been noted between transrectal ultrasound-guided biopsy results and tumor volume even when minimal amounts of tumor are found on biopsy . METHODS We identified patients who had undergone radical retropubic prostatectomy for a single microscopic focus of adenocarcinoma from a prospect ively maintained surgical data base . Patients were stratified into two groups : those with six biopsies or less and those with seven or more . The Gleason score , margin status , presence of extracapsular extension , and percentage of tumor volume were compared . RESULTS A total of 102 patients in our data base had a single microscopic focus of adenocarcinoma detected by needle biopsy . Of these patients , 65 underwent six or fewer biopsies and 37 underwent seven or more at transrectal ultrasonography . Of the 37 patients in group 2 , 27 ( 73 % ) had a final tumor volume of less than 5 % compared with 24 ( 37 % ) of 65 patients in group 1 ( P = 0.002 ) . Of the group 2 patients , 15 ( 75 % ) with Stage T1c had an estimated tumor volume of less than 5 % compared with only 11 ( 34 % ) in group 1 ( P = 0.01 ) . No statistically significant difference was noted between the two groups for margin status , presence of extracapsular extension , or Gleason score . CONCLUSIONS A single microscopic focus of cancer obtained after multiple cores predicts for a significantly lower tumor volume on final pathologic examination across clinical stages . In the context of greater tissue sampling , the minimal disease design ation may carry more predictive value and be a useful parameter in stratifying patients with Stage T1c and other good-risk factors with regard to surgical outcome 424 BMJ | 24 FEBRUARY 2007 | VOLUME 334 Almost all studies have some missing observations . Yet textbooks and software commonly assume that data are complete , and the topic of how to h and le missing data is not often discussed outside statistics journals . There are many types of missing data and different reasons for data being missing . Both issues affect the analysis . Some examples are : ( 1 ) In a postal question naire survey not all the selected individuals respond ; ( 2 ) In a r and omised trial some patients are lost to follow-up before the end of the study ; ( 3 ) In a multicentre study some centres do not measure a particular variable ; ( 4 ) In a study in which patients are assessed frequently some data are missing at some time points for unknown reasons ; ( 5 ) Occasional data values for a variable are missing because some equipment failed ; ( 6 ) Some laboratory sample s are lost in transit or technically unsatisfactory ; ( 7 ) In a magnetic resonance imaging study some very obese patients are excluded as they are too large for the machine ; ( 8) In a study assessing quality of life some patients die during the follow-up period BACKGROUND No r and omized controlled trial of prostate cancer screening has been reported and none is likely to be completed in the near future . In the absence of direct evidence , the decision to screen must therefore be based on estimates of benefits and risks . The main risk of screening is overdetection -- the detection of cancer that , if left untreated , would not cause death . In this study the authors estimate the level of overdetection that might result from annual screening of men aged 50 - 70 . METHODS The annual rate of lethal screen-detectable cancer ( detectable cancer that would prove fatal before age 85 if left untreated ) was calculated from the observed prostate cancer mortality rate in Quebec ; the annual rate of all cases of screen-detectable prostate cancer was calculated from 2 recent screening studies . RESULTS The annual rate of lethal screen-detectable prostate cancer was estimated to be 1.3 per 1000 men . The annual rate of all cases of screen-detectable prostate cancer was estimated to be 8.0 per 1000 men . The estimated case-fatality rate among men up to 85 years of age was 16 % ( 1.3/8.0 ) ( sensitivity analysis 13 % to 22 % ) . INTERPRETATION Of every 100 men with screen-detected prostate cancer , only 16 on average ( 13 to 22 ) could have their lives extended by surgery , since the prostate cancer would not cause death before age 85 in the remaining 84 ( 78 to 87 ) OBJECTIVES Evidence has been presented that biologic aggressiveness of prostate carcinoma increases with volume and that cancers less than 0.5 cc may be regarded as clinical ly insignificant for immediate treatment . We have analyzed the ability of core cancer length on needle biopsy to predict cancer volumes near the 0.5 cc threshold for distinction between incidental versus clinical carcinoma . METHODS Systematic sextant transrectal ultrasound-guided prostate biopsies were performed on 110 men who then underwent radical prostatectomy for adenocarcinoma . The core cancer length within each biopsy was compared with the volumes of clinical and incidental carcinomas in the prostatectomy specimen . RESULTS Among incidental ( nonpalpable ) cancers , 14 % of those under 0.2 cc were detected , but 44 % at 0.2 to 0.5 cc and 92 % of those more than 0.5 cc were detected . Among clinical ly suspected carcinomas , 2 mm or longer core cancer length reliably predicted a cancer of 0.5 cc or larger , but among incidental cancers , it predicted a tumor of 0.2 cc or larger . A 3-mm core cancer length threshold predicted 0.5 cc for both groups . The high frequency of incidental cancers under 0.5 cc impaired the predictive value of multiple positive needle cores . Bilateral positive biopsy results indicated bilateral extension of clinical cancer in only 59 % of cases . CONCLUSIONS A core cancer length of 3 mm or more on one or two needle biopsies reliably predicts cancer of clinical ly significant volume ( 0.5 cc or larger ) . The high detection frequency of smaller incidental carcinomas on biopsy impairs the reliability of volume estimation from multiple positive needle cores and m and ates that treatment decisions be made with knowledge of core cancer length To compare a series of 121 sextant needle biopsy sets with their corresponding radical prostatectomy specimens in screened participants in the European R and omized study of Screening for Prostate Cancer ( ERSPC ) , investigating the effect of screening for prostate cancer on disease‐specific mortality and quality of life , as the clinical significance of a small focus of well‐differentiated prostate cancer on biopsy is unclear OBJECTIVES To determine whether a very small focus of prostate cancer in a needle biopsy specimen correlates with organ-confined disease or with favorable disease parameters . METHODS Of 598 needle biopsies of the prostate performed from January 1990 through June 1994 , 49 specimens ( 8.2 % ) contained a microscopic focus ( less than 2 mm in length of the entire biopsy core specimen ) of adenocarcinoma . For these 49 patients , the clinical and pathologic features were correlated . RESULTS Of these 49 patients , 27 ( 55.1 % ) underwent either radical prostatectomy , with or without pelvic lymph node dissection ( 26 ) , or pelvic lymph node dissection alone ( 1 ) . Seven of these 27 patients ( 25.9 % ) had extraprostatic disease : lymph node involvement ( 1 ) , positive surgical margins ( 5 ) , or seminal vesicle invasion ( 1 ) . Ten of the 49 patients ( 20.4 % ) underwent radiotherapy , and 12 ( 24.5 % ) chose hormonal therapy . The pathologic stage for these 22 patients could not be ascertained . However , despite the limited amount of disease in the biopsy specimen , 2 patients treated with radiotherapy suffered a relapse ( mean interval to recurrence , 11.5 months ) , and 3 patients treated with hormonal therapy ( early or delayed ) had bony metastasis at the time of diagnosis . Overall , 12 of the 49 patients ( 24.5 % ) had unfavorable disease ( as defined by extraprostatic disease on pathologic specimen , relapse after radiotherapy , or bony metastasis at the time of diagnosis ) . CONCLUSIONS These findings suggest that a microscopic focus of prostatic adenocarcinoma in a needle biopsy specimen , per se , does not predict the pathologic stage or the biologic behavior of a tumor PURPOSE We evaluated the significance of focal prostate cancer found in sextant biopsies in men participating in a biennial prostate specific antigen ( PSA ) based screening program . MATERIAL S AND METHODS In 1995 , 10000 men 50 to 65 years old were r and omized to biennial screening with PSA testing . Sextant biopsies were recommended when total PSA was 3 ng/ml or greater at screening rounds 1 and 2 , and 2.54 ng/ml or greater at subsequent screening rounds . Focal cancer was defined as total a core cancer length of less than 3 mm in the biopsy specimen . Low volume cancer was defined as a total tumor volume of less than 0.5 cm in the radical retropubic prostatectomy specimen . RESULTS The number of men who underwent biopsy and the number of cancers detected in the 5 possible sets of biopsies were 1725 and 402 , 706 and 124 , 307 and 36 , 103 and 9 , and 13 and 0 , respectively . The risk of detecting focal cancer was 7.9 % , 10.2 % , 7.5 % , 5.8 % and 0 % , respectively , but the relative ratio ( focal-to-all cancers ) increased 34 % , 58 % , 64 % , 67 % and , not applicable , respectively . In men with a total core cancer length of less than 10 mm there was no correlation between core cancer length and total tumor volume , as measured in the prostatectomy specimen . Two-thirds of men with a total core cancer length of less than 3 mm had a tumor volume of greater than 0.5 cm , while the risk of low volume cancer was less than 5 % only in men with a total core cancer length of greater than 10 mm . CONCLUSIONS In a repeat PSA based screening program sextant biopsies are of little or no value for predicting tumor volume OBJECTIVE To distinguish good c and i date s for watchful waiting from those who need immediate treatment in localized prostate cancer . METHODS Prostate specific antigen (PSA)-doubling time ( DT ) was calculated by a log-linear regression model for 78 patients with clinical ly localized prostate cancer ( T1c : 47 , T2a : 6 , T2b : 21 , and T3 : 4 ) under surveillance . Median observation period was 37.5 months . The first 1-year PSA-DT was compared with the overall PSA-DT in 41 patients who had been under surveillance for more than 3 years . RESULTS There was significant difference in the PSA-DT distribution between a pooled group of T1c and T2a and a group of T2b and T3 patients ( median 58.8 versus 33.3 months , P = 0.0052 ) . A combination of three parameters consisting of initial PSA level less than 10 ng/ml , WHO grade 1 , one or two positive core per six to eight systematic biopsy cores with 50 % or less cancer involvement significantly correlated with PSA-DT distribution in the T1c plus T2a group ( P = 0.0034 ) . The first year assessment of PSA-DT was identical to the overall assessment in 48.8 % , 2 years or more in 36.
Output:
| The results indicated that , despite differences in study design and reporting , a significant proportion of patients with microfocal cancer , regardless of how it was defined , had adverse pathologic findings and a significant risk of PSA recurrence after undergoing radical prostatectomy .
Biochemical and clinical recurrences also were observed after radiotherapy or watchful waiting . |
MS211649 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: PURPOSE Bone resorption following tooth loss often limits the quantity of bone available for implant placement . The purpose of the present study was to evaluate the clinical outcome of 10-mm or shorter machined-surface implants when used exclusively in the treatment of various forms of edentulism . MATERIAL S AND METHODS Two hundred sixty-nine screw-type Brånemark System implants ( Nobel Biocare ) , 10 mm or shorter , were placed in 111 consecutively treated patients . Of the total , 88.8 % were placed in the m and ible and 11.2 % were placed in the maxilla ; 95.2 % were used to treat partially edentulous situations , including single-tooth losses , of which 96.6 % were in the premolar and molar regions . The patients were followed for periods of 12 to 92 months . RESULTS Of the 269 placed implants , 12 were lost . The overall survival rate was 95.5 % . Bone quality 2 and 3 ( Lekholm-Zarb classification of 1985 ) was found in 88.8 % of the treated sites . There was no statistical difference in the survival rate of the 10-mm implants when compared to the shorter series ( P > .05 ) or between the various implant diameters . The mean marginal bone loss was 0.71 + /- 0.65 mm . DISCUSSION The failure rate of 4.5 % compares favorably with that of implants of different shape , surface characteristics , and length . Bone quality appeared to be the critical factor in implant survival , rather than bone quantity , in this patient series . CONCLUSIONS This study supports the survival of short , machined-surface implants when used for the treatment of partial edentulism in bone of good quality PURPOSE The purpose of this prospect i ve multicenter study was to evaluate the efficacy of 3i threaded implants for the treatment of edentulous patients in a 1- to 5-year period . This article reports the total data and global results of 3 threaded design s of 3i implants : self-tapping , ICE , and Osseotite . MATERIAL S AND METHODS A total of 1,583 implants ( 619 ICE , 545 Osseotite , and 419 self-tapping ) were placed between 1995 and 1999 in 528 patients at 13 European clinical centers . The average age of the patients was 53.6 years . Clinical and radiographic evaluations were performed annually for up to 5 years . RESULTS Of the total implants , 707 were placed in the maxilla and 876 in the m and ible . A total of 1,162 implants were placed in posterior segments . Forty-eight implants were lost to follow-up and 55 were failures . The most frequent prosthetic indication was the short-span fixed prosthesis ( 440 cases ) , followed by 172 single-tooth replacements , 56 long-span prostheses , and 4 overdentures . Radiographic evaluation after 6 , 12 , and 24 months of implant loading showed , respectively , mean crestal bone loss of 0.04 + /- 1.3 mm , 0.12 + /- 1.6 mm , and 0.2 + /- 1.7 mm . A cumulative survival rate of 96.5 % was observed 5 years after implant placement , with 97.2 % survival in the maxilla and 95.8 % in the m and ible . The survival rate was similar in anterior ( 96.7 % ) and posterior ( 96.5 % ) segments . DISCUSSION A total of 55 failures were reported in this study with 47 early failures and 8 late failures . The rate of late failures is of utmost importance for the restorative dentist . CONCLUSION This clinical study gives evidence of very high success rates using 3 threaded design s of 3i implants The use of osseointegrated implants is an accepted procedure for the treatment of complete or partially edentulous jaws . The purpose of this prospect i ve long-term study was to evaluate the survival and success rates of endosseous dental implants ( machined surface ) in partially edentulous patients . A total of 76 patients ( 47 females , 29 males ) with 214 implants ( 68 maxillary , 146 m and ibulary ) were evaluated . Their mean age was 45 , ranging from 18 to 76 years . The implant length varied between 7 and 15 mm , the diameter between 3.4 and 6 mm . Nine implants were lost before abutment connection . Follow-up visits were scheduled at 3 and 6 months , 1 year , 2 and 3 years after insertion of the prostheses . Radiographic examination included intraoral periapical films to evaluate the horizontal and vertical bone loss . During the follow-up period , 18 implants in 10 patients were classified as failures . Fifteen implants were lost , and three implants were considered failures because of vertical bone loss greater than 0.2 mm per year after the first year of functional loading . The marginal bone loss averaged 2.1 mm in the maxillae and m and ibles . According to the Kaplan-Meier estimator the probable implant survival and success is at 93 % and 88 % respectively after 63 months . Long implants ( > 10 mm ) have a significantly better chance of survival than shorter implants ( < or = 10 mm ) . The results of this prospect i ve study indicate that 3i endosseous dental implants provide an average foundation for implant-supported restorations Forty-eight Endopore dental implants were placed in the posterior m and ibles of 24 partially edentulous patients . Seventeen of these implants replaced premolar teeth , while 31 replaced molars . Only 7-mm and 9-mm implants were used , and the majority of prosthetic restorations ( 83 % ) were single crowns . After a mean functional time of 32.6 months ( range , 8.2 to 50.3 months ) , the implant survival rate was 100 % and assessment of available radiographic data showed minimal to no crestal bone loss PURPOSE The use of implants for prosthetic rehabilitation of partially edentulous patients is increasing . However , the possibilities of placing implants in the posterior part of the m and ible are often limited . The purpose of this longitudinal study with 10 years of follow-up was to evaluate the use of short implants supporting fixed partial dentures ( FPD ) in the posterior part of the m and ible , and to compare implant supported FPDs to tooth-implant supported FPDs . MATERIAL S AND METHODS The patient material comprised 23 patients with residual m and ibular anterior teeth , and each patient received FPDs unilaterally . On one side the FPD was supported by two implants , and on the other side by one implant and one tooth , thus permitting intraindividual comparison . The distribution of the two types of FPDs in each jaw was r and omized . Implant success rates , marginal bone changes , and mechanical complications were studied . RESULTS The tooth-implant connection did not demonstrate any negative influences on the overall success rates for the 10-year period , nor were the shorter implants found to be less favorable . CONCLUSION It is suggested that a prosthetic construction supported by both a tooth and an implant may be recommended as a predictable and reliable treatment alternative in the posterior m and ible This is the first report of a group of 50 partially edentulous patients who received a total of 151 Endopore dental implants in the maxilla . A mean implant length of 8.7 mm was used , and 76.8 % of implants were placed in the posterior maxilla . At re-entry , all implants appeared to be osseointegrated and were used to support fixed prostheses . Approximately half of the crowns ( 57 % ) in these prostheses were splinted to one another , while the remainder ( 43 % ) were not . At the time of this report , the mean functional time was 34.6 months and the cumulative survival rate was 97.3 % ( 4 implants had failed ) . Analysis of carefully st and ardized sequential radiographs indicated no significant changes in mean crestal bone levels between baseline and any of the examination times ( after 6 months , 1 year , and 2 years in function ) . There were no detectable correlations between crestal bone loss and the factors implant length ( 7 , 9 , or 12 mm ) ; implant diameter ( 3.5 , 4.1 , or 5.0 mm ) ; implant position anteriorly or posteriorly in the maxilla ; or whether or not the implant-supported crowns were splinted In the present multi-center study , non-submerged ITI implants were prospect ively followed to evaluate their long-term prognosis in fully and partially edentulous patients . In a total of 1003 patients , 2359 implants were consecutively inserted . Following a healing period of 3 - 6 months , the successfully integrated implants were restored with 393 removable and 758 fixed restorations . Subsequently , all consecutive implants were documented annually up to 8 years . At each examination , the clinical status of all implants was evaluated according to predefined criteria of success . Therefore , the data base allowed the evaluation of 8-year cumulative survival and success rates for 2359 implants . In addition , cumulative success rates were calculated for implant subgroups divided per implant type , implant length , and implant location . Furthermore , the actual 5-year survival and success rates could be determined for 488 implants . During the healing period , 13 implants did not successfully integrate , whereas 2346 implants fulfilled the predefined criteria of success . This corresponds with an early failure rate of 0.55 % . During follow-up , 19 implants were classified as failures due to several reasons . In addition , 17 implants ( approximately 0.8 % ) demonstrated at the last annual examination a suppurative periimplant infection . Including 127 drop out implants (= 5.4 % drop out rate ) into the calculation , the 8-year cumulative survival and success rates result ed in 96.7 % and 93.3 % , respectively . The analysis of implant subgroups showed slightly more favorable cumulative success rates for screw type implants ( > 95 % ) compared to hollow-cylinder implants ( 91.3 % ) , and clearly better success rates for m and ibular implants ( approximately 95 % ) when compared to maxillary implants ( approximately 87 % ) . The actual 5-year survival and success rates of 488 implants with 98.2 % and 97.3 % , respectively , were slightly better than the estimated 5-year cumulative survival and success rates of 2359 implants indicating that the applied life table analysis is a reliable statistical method to evaluate the long-term prognosis of dental implants . It can be concluded that non-submerged ITI implants maintain success rates well above 90 % in different clinical centers for observation periods up to 8 years PURPOSE Controversy over the long-term clinical effectiveness of hydroxyapatite (HA)-coated dental implants still persists , despite numerous clinical studies documenting high survival rates . The Ohio State University College of Dentistry undertook a 5-year prospect i ve study of 429 HA-coated cylindric implants placed into 121 patients to determine the long-term clinical performance of the implants . MATERIAL S AND METHODS All study subjects were patients screened and evaluated in the university 's dental clinic by one of the principal investigators and one member of the surgical team . A total of 429 HA-coated implants were placed in 121 patients . The Ohio State University Human Subjects Committee approved and review ed this study . RESULTS At the time of this report , 375 implants had completed 5 years of clinical follow-up . Beyond the 5-year limit of the study , 282 implants had completed 6 years and 114 implants had completed 7 years of clinical monitoring . The cumulative survival rate was 96 % at 5 years and 95 % at 7 years of follow-up . Mean combined mesial/distal bone loss was 1.2 mm in the m and ible and 1.4 mm in the maxilla after 5 years of functional loading . Implant failures were most commonly associated with short implants or angled abutments . DISCUSSION Prospect i ve clinical data are extremely valuable for clinicians evaluating the reliability of dental implant systems . In the present study , the implants achieved 100 % osseointegration with minimal marginal bone loss , and 96 % of the implants remained in function at 5 years . CONCLUSION The HA-coated cylindric implants in this study provided a predictable means of oral rehabilitation BACKGROUND Placement of implants into molar positions presents diagnostic , surgical and prosthetic challenges . There are few reported studies for implants placed into molar positions . The purpose of this prospect i ve longitudinal study is to report long-term clinical outcomes for 282 implants placed into molar positions . METHODS Two-hundred-twelve patients received 282 implants . Implant size , location , jaw shape , and bone quality were recorded for all implants placed into molar positions . Seventy implants were inserted in maxillae and 212 in m and ibles . Marginal bone level changes in maxillae and m and ibles were measured from non-st and ardized periapical radiographs taken at abutment connection and an average follow-up of 3.9 years . Mesial-distal implant measurements were made from the top of the implant cylinder to the first point of bone to implant contact . In m and ibles , 39 implants were used for single molar replacements , 67 implants were placed into excellent bone quality ( type I ) and
Output:
| There is fair evidence that short ( < 10 mm ) implants can be placed successfully in the partially edentulous patient , although with a tendency towards an increasing survival rate per implant length , and the prognosis may be better in the m and ible of non smoking patients |
MS211650 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Obese women with the polycystic ovary syndrome are relatively unresponsive to the induction of ovulation by clomiphene . We hypothesized that reducing insulin secretion by administering metformin would increase the ovulatory response to clomiphene . METHODS We performed oral glucose-tolerance tests before and after the administration of 500 mg of metformin or placebo three times daily for 35 days in 61 obese women with the polycystic ovary syndrome . Women who did not ovulate spontaneously were then given 50 mg of clomiphene daily for five days while continuing to take metformin or placebo . Serum progesterone was measured on days 14 , 28 , 35 , 44 , and 53 , and ovulation was presumed to have occurred if the concentration exceeded 8 ng per milliliter ( 26 nmol per liter ) on any of these days . RESULTS Twenty-one women in the metformin group and 25 women in the placebo group were given clomiphene because they did not ovulate spontaneously during the first phase of the study . Among the 21 women given metformin plus clomiphene , the mean ( + /-SE ) area under the serum insulin curve after oral glucose administration decreased from 6745+/-2021 to 3479+/-455 microU per milliliter per minute ( 40.5+/-12.1 to 20.9+/-2.7 nmol per liter per minute , P=0.03 ) , but it did not change significantly in the 25 women given placebo plus clomiphene . Nineteen of the 21 women ( 90 percent ) who received metformin plus clomiphene ovulated ( mean peak serum progesterone concentration , 23.8+/-3.4 ng per milliliter [ 7.6+/-10.9 nmol per liter ] ) . Two of the 25 women ( 8 percent ) who received placebo plus clomiphene ovulated ( P<0.001 ) . Overall , 31 of the 35 women ( 89 percent ) treated with metformin ovulated spontaneously or in response to clomiphene , as compared with 3 of the 26 women ( 12 percent ) treated with placebo . CONCLUSIONS The ovulatory response to clomiphene can be increased in obese women with the polycystic ovary syndrome by decreasing insulin secretion with metformin BACKGROUND Medical induction of ovulation using clomiphene citrate ( CC ) as first line and exogenous gonadotrophins as second line forms the classical treatment algorithm in normogonadotrophic anovulatory infertility . Because the chances of success following classical ovulation induction are not well established , a shift in first-line therapy can be observed towards alternative treatment . The study aim was to : ( i ) reliably assess the probability of singleton live birth following classical induction of ovulation ; and ( ii ) construct a prediction model , based on individual patient characteristics assessed upon st and ardized initial screening , to help identify patients with poor chances of success . METHODS A total of 240 consecutive women visiting a specialist academic fertility unit with a history of infertility , oligomenorrhoea or amenorrhoea , and normal FSH and estradiol serum concentrations ( WHO group 2 ) was prospect ively followed . The women had not been previously treated with ovulation-inducing agents . All patients commenced with CC . Patients who did not ovulate within three treatment cycles of incremental daily doses up to 150 mg for 5 consecutive days or ovulatory CC patients who did not conceive within six cycles , subsequently underwent gonadotrophin induction of ovulation applying a step-down dose regimen . The main outcome measure was pregnancy result ing in singleton live birth . Cox regression was used to construct a multivariable prediction model . RESULTS Overall , there were 134 pregnancies ending in a singleton live birth ( 56 % of women ) . The cumulative pregnancy rate after 12 and 24 months of follow-up was 50 % and 71 % respectively . Polycystic ovary syndrome ( PCOS ) patients ( 49 % ) , clearly non-PCOS patients ( 13 % ) and the in-between group did not differ in prognosis ( P = 0.9 ) . The multivariable Cox regression model contained the woman 's age , the insulin : glucose ratio and duration of infertility . With a cut-off value of 30 % for low chance , the model predicted probabilities at 12 months lower than this cut-off for 25 out of 240 patients ( 10.4 % ) . CONCLUSIONS Classical ovulation induction produces very good results in normogonadotrophic anovulatory infertility . Alternative treatment options may not be indicated as first-line therapy in these patients , except for subgroups with poor prognosis . These women can be identified by older age , longer duration of infertility and higher insulin : glucose ratio BACKGROUND Insulin resistance and increased ovarian cytochrome P450c17 alpha activity are both features of the polycystic ovary syndrome . P450c17 alpha , which is involved in and rogen bio synthesis , has both 17 alpha-hydroxylase and 17,20-lyase activities . Increased activity of this enzyme results in exaggerated conversion of progesterone to 17 alpha-hydroxyprogesterone in response to stimulation by gonadotrophin . We hypothesized that hyperinsulinemia stimulates ovarian P450c17 alpha activity . METHODS We measured fasting serum steroid concentrations and the response of serum 17 alpha-hydroxyprogesterone to leuprolide , a gonadotrophin-releasing hormone agonist , and performed oral glucose-tolerance tests before and after oral administration of either metformin ( 500 mg three times daily ) or placebo for four to eight weeks in 24 obese women with the polycystic ovary syndrome . RESULTS In the 11 women given metformin , the mean ( + /- SE ) area under the serum insulin curve after oral glucose administration decreased from 9303 + /- 1603 to 4982 + /- 911 microU per milliliter per minute ( 56 + /- 10 to 30 + /- 6 nmol per liter per minute ) ( P = 0.004 ) . This decrease was associated with a reduction in the basal serum 17 alpha-hydroxyprogesterone concentration from 135 + /- 21 to 66 + /- 7 ng per deciliter ( 4.1 + /- 0.6 to 2.0 + /- 0.2 nmol per liter ) ( P = 0.01 ) and a reduction in the leuprolide-stimulated peak serum 17 alpha-hydroxyprogesterone concentration from 455 + /- 54 to 281 + /- 52 ng per deciliter ( 13.7 + /- 1.6 to 8.5 + /- 1.6 nmol per liter ) ( P = 0.01 ) . The serum 17 alpha-hydroxyprogesterone values increased slightly in the placebo group . In the metformin group , the basal serum luteinizing hormone concentration decreased from 8.5 + /- 2.2 to 2.8 + /- 0.5 mlU per milliliter ( P = 0.01 ) , the serum free testosterone concentration decreased from 0.34 + /- 0.07 to 0.19 + /- 0.05 ng per deciliter ( 12 + /- 3 to 7 + /- 2 pmol per liter ) ( P = 0.009 ) , and the serum sex hormone-binding globulin concentration increased from 0.8 + /- 0.2 to 2.3 + /- 0.6 microgram per deciliter ( 29 + /- 7 to 80 + /- 21 nmol per liter ) ( P < 0.001 ) . None of these values changed significantly in the placebo group . CONCLUSIONS In obese women with the polycystic ovary syndrome , decreasing serum insulin concentrations with metformin reduces ovarian cytochrome P450c17 alpha activity and ameliorates hyper and rogenism BACKGROUND This study aims to evaluate the impact of metformin on ovarian response when co-administered during recombinant (r)FSH using the low-dose step-up protocol in clomiphene citrate-resistant polycystic ovarian syndrome ( PCOS ) patients with normal glucose tolerance . METHODS AND RESULTS Thirty-two patients were r and omized to metformin ( n = 16 ) and placebo ( n = 16 ) groups . Hormonal assessment , a 75 g oral glucose tolerance test ( OGTT ) and a frequently sample d i.v . glucose tolerance test ( FSIGTT ) were performed before and after oral administration of metformin ( 850 mg twice daily ) or placebo for 6 weeks . Recombinant FSH treatment was undertaken , thereafter , in women who did not ovulate on metformin ( n = 10 ) or placebo ( n = 15 ) . There was no significant change in all insulin sensitivity indices in both groups . The only change noted was a decline in mean serum free testosterone concentration in the metformin group ( P = 0.049 ) . One patient on placebo and six patients on metformin ovulated spontaneously ( P < 0.05 ) . All parameters of ovarian response were comparable between the two groups during rFSH treatment . Combining the 6 week placebo or metformin-only period with a single rFSH treatment cycle , the overall ovulation rates were 75 and 94 % in the placebo and metformin groups respectively ( P > 0.05 ) . The respective figures for pregnancy were 6.3 and 31.3 % ( P > 0.05 ) . CONCLUSIONS Metformin may restore ovulation with no improvement on insulin resistance in clomiphene citrate-resistant PCOS patients with normal glucose tolerance , but has no significant effect on ovarian response during rFSH treatment In 43 amenorrheic women with polycystic ovary syndrome ( PCOS ) , 31 ( 74 % ) with fasting hyperinsulinemia ( > or = 20 microU/mL ) , our aim was to determine whether Metformin ( Bristol-Myers Squibb , Princeton , NJ ) , which reduces hyperinsulinemia , would reverse the endocrinopathy of PCOS , allowing resumption of regular normal menses . A second aim was to assess the effects of weight loss versus other Metformin-induced effects on ovarian function , and to determine if there were different responses to Metformin between those who lost weight and those who did not . A third aim was to assess associations between PCOS , 4G/5 G polymorphism in the promoter sequence of the plasminogen activator inhibitor-1 gene ( PAI-1 gene ) , and PAI activity ( PAI-Fx ) . Of the 43 women , 40 ( 93 % ) had normal fasting blood glucose and 37 had normal hemoglobin A1C ( HgA1C ) ; onlythree ( 7 % ) had type 2 diabetes mellitus . Metformin ( 1.5 to 2.25 g/d ) was given for 6.1+/-5.1 months ( range , 1.5 to 24 ) , to 16 patients for less than 3 months , to 12 for 3 to 6 months , and to 15 for at least 6 months . On Metformin , 39 of 43 patients ( 91 % ) resumed normal menses . The percentage of women resuming normal menses did not differ among treatment duration groups ( P<.1 ) or among dose groups ( P>.1 ) . The body mass index ( BMI ) decreased from 36.4 + 7 Kg/m2 at study entry to 35.1+/-6.7 on Metformin ( P=.0008 ) . Of 43 patients , 28 ( 67 % ) lost weight ( 1 to 69 pounds ) , with nine ( 21 % ) losing at least 12 pounds . On Metformin , the median fasting serum insulin decreased from 26 microU/mL to 22 ( P=.019 ) , testosterone decreased from 61 ng/dL to 47 ( P=.003 ) , and estradiol increased from 41 pg/mL to 71 ( P=.0001 ) . Metformin-induced improvements in ovarian function were independent of weight loss ( testosterone decrease , P<.002 ; estradiol increase , P<.0004 ) . The change in response variables on Metformin did not differ ( P>.05 ) between those who lost weight and those who did not , excepting Lp(a ) , which increased 4 mg/dL in those who lost weight and decreased 9 mg/dL in those who did not ( P = .003 ) . The change in response variables on Metformin did not differ among the five quintiles of weight loss , excepting fasting glucose ( P<.05 ) , which increased 6 mg/dL in those who lost the least weight on Metformin versus those in the 60th to 80th percentile for weight loss , in whom glucose decreased 33 mg/dL. Although the pretreatment fasting serum insulin was not significantly correlated with testosterone ( r=.24 , P=.13 ) or and rostenedione ( r=.27 , P=.09 ) , on Metformin , the change
Output:
| Metformin is effective for ovulation induction and cycle regulation in this group of patients .
Metformin plus CC appears to be very effective for achievement of pregnancy compared to CC alone . |
MS211651 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The present study evaluated a new integrated treatment concept offering inpatient care , acute psychiatric day hospital and outpatient treatment by the same therapeutic team . 178 patients participated in this r and omized controlled trial . Data on psychopathology , global and social functioning , patient satisfaction , continuity of care and administrative data was gathered on admission , throughout the course of treatment , upon discharge and at 1-year follow-up . In addition , the physicians in charge rated the therapeutic relationship . The data analysis consists of group-wise comparisons and regression analyses ( cross-tabulations and χ2 test statistics for categorical data and Mann – Whitney U tests for continuous data ) . Differences between groups over time were analyzed with a series of generalized linear mixed model . The integrated care group showed a significant reduction in psychopathological impairment ( 20.7 % ) and an improvement of psychosocial functioning ( 36.8 % ) . The mean number of days before re-admission was higher in the control group when compared to the integrated care group ( 156.8 vs. 91.5 ) . There was no difference in the number of re-admissions and days spent in psychiatric institutions . This new approach offers a treatment model , which facilitates continuity of care . Beside it improves psychopathological outcome measures and psychosocial functioning in patients with mental illness Objectives To evaluate the association between the degree of integration in community mental health teams ( CMHTs ) and : ( i ) the costs of service provision ; ( ii ) rates of mental health inpatient and care home admission . Methods An observational study of service use and admissions to institutional care was undertaken for a prospect ively‐ sample d cohort of patients from eight CMHTs in Engl and . Teams were chosen to represent ‘ high ’ or ‘ low ’ levels of integrated working practice and patients were followed‐up for seven months . General linear models were used to estimate service costs and the likelihood of institutional admission . Results Patients supported by high integration teams received services costing an estimated 44 % more than comparable patients in low integration teams . However , after controlling for case mix , no significant differences were found in the likelihood of admission to mental health inpatient wards or care homes between team types . Conclusions Integrated mental health and social care teams appeared to facilitate greater access to community care services , but no consequent association was found with community tenure . Further research is required to identify the necessary and sufficient components of integrated community mental health care , and its effect on a wider range of outcomes using patient‐reported measures . © 2016 The Authors . International Journal of Geriatric Psychiatry published by John Wiley & Sons , IMPORTANCE Accountable care contracts hold physician groups financially responsible for the quality and cost of health care delivered to patients . Focusing on clinical ly vulnerable patients , those with serious conditions who are responsible for the greatest proportion of spending , may result in the largest effects on both patient outcomes and financial rewards for participating physician groups . OBJECTIVE To estimate the effect of Medicare accountable care organization ( ACO ) contracts on spending and high-cost institutional use for all Medicare beneficiaries and for clinical ly vulnerable beneficiaries . DESIGN , SETTING , AND PARTICIPANTS For this cohort study , 2 study population s were defined : the overall Medicare population and the clinical ly vulnerable subgroup of Medicare beneficiaries . The overall Medicare population was based on a r and om 40 % sample drawn from continuously enrolled fee-for-service beneficiaries with at least 1 evaluation and management visit in a calendar year . The clinical ly vulnerable study population included all Medicare beneficiaries 66 years or older who had at least 3 Hierarchical Condition Categories ( HCCs ) . Beneficiaries entered the cohort during the quarter between January 2009 to December 2011 when they first had at least 3 HCCs and remained in the cohort until death . Cohort entry was restricted to the preperiod to account for potential changes in coding practice s after ACO implementation . Difference-in-difference estimations were used to compare changes in health care outcomes for Medicare beneficiaries attributed to physicians in ACOs with those attributed to non-ACO physicians from January 2009 to December 2013 . EXPOSURES Medicare ACOs beginning contracts in January 2012 , April 2012 , July 2012 , and January 2013 through the Pioneer and Medicare Shared Savings Programs . MAIN OUTCOMES AND MEASURES Total spending per beneficiary-quarter , spending categories , use of hospitals and emergency departments , ambulatory care sensitive admissions , and 30-day readmissions . RESULTS Total spending decreased by $ 34 ( 95 % CI , -$52 to -$15 ) per beneficiary-quarter after ACO contract implementation across the overall Medicare population ( n = 15 592 600 ) and decreased $ 114 in clinical ly vulnerable patients ( n = 8 673 823 ) ( 95 % CI , -$178 to -$50 ) . In the overall Medicare cohort , hospitalizations and emergency department visits decreased by 1.3 and 3.0 events per 1000 beneficiaries per quarter , respectively ( 95 % CIs : -2.1 to -0.4 and -4.8 to -1.3 ) , and hospitalizations and emergency department visits decreased in the clinical ly vulnerable cohort by 2.9 and 4.1 events per 1000 beneficiaries per quarter , respectively ( 95 % CIs : -5.2 to -0.7 and -7.1 to -1.2 ) . Changes in total spending associated with ACOs did not vary by clinical condition of beneficiaries . CONCLUSIONS AND RELEVANCE Medicare ACO programs are associated with modest reductions in spending and use of hospitals and emergency departments . Savings were realized through reductions in use of institutional setting s in clinical ly vulnerable patients Background : “ Referral ” characterises a significant area of interaction between primary and secondary care . Despite advantages , it can be inflexible , and may lead to duplication . Objective : To examine the outcomes of an integrated model that lends weight to general practitioner (GP)-led evidence based care . Design : A prospect i ve , non-r and om comparison of two services : women attending the new ( Bridges ) pathway compared with those attending a consultant-led one-stop menstrual clinic ( OSMC ) . Patients ’ views were examined using patient career diaries , health and clinical outcomes , and re source utilisation . Follow-up was for 8 months . Setting : A large teaching hospital and general practice s within one primary care trust ( PCT ) . Results : Between March 2002 and June 2004 , 99 women in the Bridges pathway were compared with 94 women referred to the OSMC by GPs from non-participating PCTs . The patient career diary demonstrated a significant improvement in the Bridges group for patient information , fitting in at the point of arrangements made for the patient to attend hospital ( ease of access ) ( p<0.001 ) , choice of doctor ( p = 0.020 ) , waiting time for an appointment ( p<0.001 ) , and less “ limbo ” ( patient experience of non-coordination between primary and secondary care ) ( p<0.001 ) . At 8 months there were no significant differences between the two groups in surgical and medical treatment rates or in the use of GP clinic appointments . Significantly fewer ( traditional ) hospital outpatient appointments were made in the Bridges group than in the OSMC group ( p<0.001 ) . Conclusion : A general practice -led model of integrated care can significantly reduce outpatient attendance while improving patient experience , and maintaining the quality of care CONTEXT Most older adults with dementia will be cared for by primary care physicians , but the primary care practice environment presents important challenges to providing quality care . OBJECTIVE To test the effectiveness of a collaborative care model to improve the quality of care for patients with Alzheimer disease . DESIGN , SETTING , AND PATIENTS Controlled clinical trial of 153 older adults with Alzheimer disease and their caregivers who were r and omized by physician to receive collaborative care management ( n = 84 ) or augmented usual care ( n = 69 ) at primary care practice s within 2 US university-affiliated health care systems from January 2002 through August 2004 . Eligible patients ( identified via screening or medical record ) met diagnostic criteria for Alzheimer disease and had a self-identified caregiver . INTERVENTION Intervention patients received 1 year of care management by an interdisciplinary team led by an advanced practice nurse working with the patient 's family caregiver and integrated within primary care . The team used st and ard protocol s to initiate treatment and identify , monitor , and treat behavioral and psychological symptoms of dementia , stressing nonpharmacological management . MAIN OUTCOME MEASURES Neuropsychiatric Inventory ( NPI ) administered at baseline and at 6 , 12 , and 18 months . Secondary outcomes included the Cornell Scale for Depression in Dementia ( CSDD ) , cognition , activities of daily living , re source use , and caregiver 's depression severity . RESULTS Initiated by caregivers ' reports , 89 % of intervention patients triggered at least 1 protocol for behavioral and psychological symptoms of dementia with a mean of 4 per patient from a total of 8 possible protocol s. Intervention patients were more likely to receive cholinesterase inhibitors ( 79.8 % vs 55.1 % ; P = .002 ) and antidepressants ( 45.2 % vs 27.5 % ; P = .03 ) . Intervention patients had significantly fewer behavioral and psychological symptoms of dementia as measured by the total NPI score at 12 months ( mean difference , -5.6 ; P = .01 ) and at 18 months ( mean difference , -5.4 ; P = .01 ) . Intervention caregivers also reported significant improvements in distress as measured by the caregiver NPI at 12 months ; at 18 months , caregivers showed improvement in depression as measured by the Patient Health Question naire-9 . No group differences were found on the CSDD , cognition , activities of daily living , or on rates of hospitalization , nursing home placement , or death . CONCLUSIONS Collaborative care for the treatment of Alzheimer disease result ed in significant improvement in the quality of care and in behavioral and psychological symptoms of dementia among primary care patients and their caregivers . These improvements were achieved without significantly increasing the use of antipsychotics or sedative-hypnotics . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00246896 OBJECTIVE T o examine whether quality of care ( QOC ) improves when nurse practitioners and pharmacists work with family physicians in community practice and focus their work on patients who are 50 years of age and older and considered to be at risk of experiencing adverse health outcomes . DESIGN R and omized controlled trial . SETTING A family health network with 8 family physicians , 5 nurses , and 11 administrative personnel serving 10 000 patients in a rural area near Ottawa , Ont . PARTICIPANTS Patients 50 years of age and older at risk of experiencing adverse health outcomes ( N = 241 ) . INTERVENTIONS At-risk patients were r and omly assigned to receive usual care from their family physicians or Anticipatory and Preventive Team Care ( APTCare ) from a collaborative team composed of their physicians , 1 of 3 nurse practitioners , and a pharmacist . MAIN OUTCOME MEASURES Quality of care for chronic disease management ( CDM ) for diabetes , coronary artery disease , congestive heart failure , and chronic obstructive pulmonary disease . RESULTS Controlling for baseline demographic characteristics , the APTCare approach improved CDM QOC by 9.2 % ( P < .001 ) compared with traditional care . The APTCare intervention also improved preventive care by 16.5 % ( P < .001 ) . We did not observe significant differences in other secondary outcome measures ( intermediate clinical outcomes , quality of life [ Short-Form 36 and health-related quality of life scales ] , functional status [ instrumental activities of daily living scale ] and service usage ) . CONCLUSION Additional re sources in the form of collaborative multidisciplinary care teams with intensive interventions in primary care can improve QOC for CDM in a population of older at-risk patients . The appropriateness of this intervention will depend on its cost-effectiveness . TRIAL REGISTRATION NUMBER NCT00238836 ( CONSORT ) OBJECTIVE To document outcomes of a r and omized trial of the PhoenixCare demonstration program of palliative care and coordinated care/case management for seriously chronically ill individuals who simultaneously received active treatment from managed care organizations ( MCOs ) . DESIGN Patients , continuously enrolled between July 1999 , and March 2001 , were r and omly assigned to the PhoenixCare program or a control group receiving usual MCO care . SETTING Hospice of the Valley , Phoenix , Arizona . PARTICIPANTS Participants were 192 patients with chronic obstructive pulmonary disease ( COPD ) or chronic heart failure ( CHF ) , who had an estimated 2-year life expectancy . INTERVENTION Intensive home-based case management provided by registered nurse casemanagers , in coordination with patients ' existing source of medical care , comprised the intervention . Program foci included disease and symptom management , patient self-management of illness and knowledge of illness-related re sources , preparation for end-of life , physical and mental functioning , and utilization of medical services . OUTCOME MEASURES Outcomes , assessed every 3 months by telephone interview , included measures related to all program foci ; the SF-36 was used to evaluate physical and mental functioning ; emergency department visits exemplified medical service utilization . RESULTS Compared to controls , PhoenixCare patients exhibited significantly better outcomes on self-management of illness , awareness of illness-related re sources , and legal preparation for end of life . They reported
Output:
| Analysis indicated evidence of perceived improved quality of care , evidence of increased patient satisfaction , and evidence of improved access to care .
Evidence was rated as either inconsistent or limited regarding all other outcomes reported , including system-wide impacts on primary care , secondary care , and health care costs .
Conclusions Models of integrated care may enhance patient satisfaction , increase perceived quality of care , and enable access to services , although the evidence for other outcomes including service costs remains unclear . |
MS211652 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE Appropriate caloric intake in critically ill patients receiving enteral nutrition is controversial . This study evaluates the impact of different caloric regimens on severity of organ failure measured with Sequential Organ Failure Assessment ( SOFA ) . MATERIAL S AND METHODS We conducted a r and omized prospect i ve controlled trial . Study population included adult intensive care unit ( ICU ) patients expected to require enteral nutrition for more than 96 hours . Goals in the intervention group were hypocaloric ( 15 kcal/kg per day ) enteral nutrition compared to normocaloric ( 25 kcal/kg per day ) enteral nutrition , both with hyperproteic intake ( 1.7 g of protein/kg per day ) . Primary end point was change in SOFA score ( ΔSOFA ) from baseline at 48 hours . Secondary end points were ΔSOFA at 96 hours , insulin requirements , hyperglycemia or hypoglycemic episodes , length of ICU stay , days on ventilator , and 28-day mortality . RESULTS After screening 443 patients , 120 patients were analyzed . There were no differences between groups in baseline characteristics . We did not find a statistically significant difference in ΔSOFA at 48 hours . Patients in the hypocaloric group showed lower average daily insulin requirements and percentage of patients requiring any insulin . CONCLUSIONS Hyperproteic , hypocaloric nutrition did not show different outcomes compared to normocaloric nutrition , except lower insulin requirements . Hypocaloric nutrition could provide a more physiologic approach with lower need for care and metabolic impact Purpose Many investigators have reported rising numbers of elderly patients admitted to the intensive care units ( ICUs ) . The aim of the study was to estimate the prevalence of malnutrition risk in the ICU by comparing the prevalence of malnutrition between older adults ( aged 65 years and above ) and adults ( aged 18–64 years ) , and to examine the negative consequences associated with risk of malnutrition in older adults . Material s and methods A prospect i ve cohort study in the ICU of the University Hospital Center of Tirana , Albania , was conducted . Logistic regression analysis was used to analyze the effect of malnutrition risk on the length of ICU stay , the duration of being on the ventilator , the total complications , the infectious complications , and the mortality . Results In this study , 963 patients participated , of whom 459 patients ( 47.7 % ) were aged ≥65 years . The prevalence of malnutrition risk at the time of ICU admission of the patients aged ≥65 years old was 71.24 % . Logistic regression adjusted for confounders showed that malnutrition risk was an independent risk factor of poor clinical outcome for elderly ICU patients , for 1 ) infections ( odds ratio [ OR ] = 4.37 ; 95 % confidence interval [ CI ] : 2.61–7.31 ) ; 2 ) complications ( OR = 6.73 ; 95 % CI : 4.26–10.62 ) ; 3 ) mortality ( OR = 2.68 ; 95 % CI : 1.72–4.18 ) ; and 4 ) ICU length of stay > 14 days ( OR = 5.18 , 95 % CI : 2.43–11.06 ) . Conclusion Malnutrition risk is highly prevalent among elderly ICU patients , especially among severely ill patients with malignancy admitted to the emergency ward . ICU elderly patients at malnutrition risk will have higher complication and infection rates , longer duration of ICU stay , and increased mortality . Efforts should be made to implement a variety of nutritional care strategies , to change the nutritional practice s not only at ward level , but nationally , according to the best clinical practice and recent guidelines Introduction : Our aim was to evaluate the impact of hyperproteic hypocaloric enteral feeding on clinical outcomes in critically ill patients , particularly on severity of organic failure measured with the Sequential Organ Failure Assessment ( SOFA ) . Material s and Methods : In a double blind clinical trial , 80 critically ill adult patients were r and omized to hyperproteic hypocaloric or to isocaloric enteral nutrition ; all patients completed follow-up of at least 4 days . Prescribed caloric intake was : Hyperproteic hypocaloric enteral nutrition ( 15 kcal/kg with 1.7 g/kg of protein ) or isocaloric enteral nutrition ( 25 kcal/kg with 20 % of the calories as protein ) . The main outcome was the differences in delta SOFA at 48 h. Secondary outcomes were intensive care unit ( ICU ) length of stay , days on ventilator , hyperglycemic events , and insulin requirements . Results : There were no differences in SOFA score at baseline ( 7.5 ( st and ard deviation ( SD ) 2.9 ) vs 6.7 ( SD 2.5 ) P = 0.17 ) . The total amount of calories delivered was similarly low in both groups ( 12 kcal/kg in intervention group vs 14 kcal/kg in controls ) , but proteic delivery was significantly different ( 1.4 vs 0.76 g/kg , respectively P ≤ 0.0001 ) . The intervention group showed an improvement in SOFA score at 48 h ( delta SOFA 1.7 ( SD 1.9 ) vs 0.7 ( SD 2.8 ) P = 0.04 ) and less hyperglycemic episodes per day ( 1.0 ( SD 1.3 ) vs 1.7 ( SD 2.5 ) P = 0.017 ) . Discussion : Enteral hyperproteic hypocaloric nutrition therapy could be associated with a decrease in multiple organ failure measured with SOFA score . We also found decreased hyperglycemia and a trend towards less mechanical ventilation days and ICU length of stay BACKGROUND Nutritional support has been recognized as an essential part of intensive care unit management . However , the appropriate caloric intake for critically ill patients remains ill defined . OBJECTIVE We examined the effect of permissive underfeeding compared with that of target feeding and of intensive insulin therapy ( IIT ) compared with that of conventional insulin therapy ( CIT ) on the outcomes of critically ill patients . DESIGN This study had a 2 × 2 factorial , r and omized , controlled design . Eligible patients were r and omly assigned to permissive underfeeding or target feeding groups ( caloric goal : 60 - 70 % compared with 90 - 100 % of calculated requirement , respectively ) with either IIT or CIT ( target blood glucose : 4.4 - 6.1 compared with 10 - 11.1 mmol/L , respectively ) . RESULTS Twenty-eight-day all-cause mortality was 18.3 % in the permissive underfeeding group compared with 23.3 % in the target feeding group ( relative risk : 0.79 ; 95 % CI : 0.48 , 1.29 ; P = 0.34 ) . Hospital mortality was lower in the permissive underfeeding group than in the target group ( 30.0 % compared with 42.5 % ; relative risk : 0.71 ; 95 % CI : 0.50 , 0.99 ; P = 0.04 ) . No significant differences in outcomes were observed between the IIT and CIT groups . CONCLUSION In critically ill patients , permissive underfeeding may be associated with lower mortality rates than target feeding . This trial was registered at controlled-trials.com as IS RCT N96294863 Objective To evaluate the effect of initial low energy permissive underfeeding ( “ trophic feeding ” ) versus full energy enteral feeding ( “ full feeding ” ) on physical function and secondary outcomes in patients with acute lung injury . Design Prospect i ve longitudinal follow-up evaluation of the NHLBI ARDS Clinical Trials Network ’s EDEN trial Setting 41hospitals in the United States . Participants 525 patients with acute lung injury . Interventions R and omised assignment to trophic or full feeding for up to six days ; thereafter , all patients still receiving mechanical ventilation received full feeding . Measurements Blinded assessment of the age and sex adjusted physical function domain of the SF-36 instrument at 12 months after acute lung injury . Secondary outcome measures included survival ; physical , psychological , and cognitive functioning ; quality of life ; and employment status at six and 12 months . Results After acute lung injury , patients had substantial physical , psychological , and cognitive impairments , reduced quality of life , and impaired return to work . Initial trophic versus full feeding did not affect mean SF-36 physical function at 12 months ( 55 ( SD 33 ) v 55 ( 31 ) , P=0.54 ) , survival to 12 months ( 65 % v 63 % , P=0.63 ) , or nearly all of the secondary outcomes . Conclusion In survivors of acute lung injury , there was no difference in physical function , survival , or multiple secondary outcomes at 6 and 12 month follow-up after initial trophic or full enteral feeding . Trial Registration NCT No BACKGROUND Proper caloric intake goals in critically ill surgical patients are unclear . It is possible that overnutrition can lead to hyperglycemia and an increased risk of infection . OBJECTIVE This study was conducted to determine whether surgical infection outcomes in the intensive care unit ( ICU ) could be improved with the use of hypocaloric nutritional support . DESIGN Eighty-three critically ill patients were r and omly allocated to receive either the st and ard calculated daily caloric requirement of 25 - 30 kcal · kg(-1 ) · d(-1 ) ( eucaloric ) or 50 % of that value ( hypocaloric ) via enteral tube feeds or parenteral nutrition , with an equal protein allocation in each group ( 1.5 g · kg(-1 ) · d(-1 ) ) . RESULTS There were 82 infections in the hypocaloric group and 66 in the eucaloric group , with no significant difference in the mean ( ± SE ) number of infections per patient ( 2.0 ± 0.6 and 1.6 ± 0.2 , respectively ; P = 0.50 ) , percentage of patients acquiring infection [ 70.7 % ( 29 of 41 ) and 76.2 % ( 32 of 42 ) , respectively ; P = 0.57 ] , mean ICU length of stay ( 16.7 ± 2.7 and 13.5 ± 1.1 d , respectively ; P = 0.28 ) , mean hospital length of stay ( 35.2 ± 4.9 and 31.0 ± 2.5 d , respectively ; P = 0.45 ) , mean 0600 glucose concentration ( 132 ± 2.9 and 135 ± 3.1 mg/dL , respectively ; P = 0.63 ) , or number of mortalities [ 3 ( 7.3 % ) and 4 ( 9.5 % ) , respectively ; P = 0.72 ] . Further analyses revealed no differences when analyzed by sex , admission diagnosis , site of infection , or causative organism . CONCLUSIONS Among critically ill surgical patients , caloric provision across a wide acceptable range does not appear to be associated with major outcomes , including infectious complications . The optimum target for caloric provision remains elusive Objective : Enteral nutrition is provided to mechanically ventilated patients who can not eat normally , yet the amount of support needed is unknown . We conducted this r and omized , open-label study to test the hypothesis that initial low-volume ( i.e. , trophic ) enteral nutrition would decrease episodes of gastrointestinal intolerance/complications and improve outcomes as compared to initial full-energy enteral nutrition in patients with acute respiratory failure . Design : R and omized , open-label study . Patients : A total of 200 patients with acute respiratory failure expected to require mechanical ventilation for at least 72 hrs . Interventions : Patients were r and omized to receive either initial trophic ( 10 mL/hr ) or full-energy enteral nutrition for the initial 6 days of ventilation . Measurements and Main Results : The primary outcome measure was ventilator-free days to day 28 . Baseline characteristics were similar between the 98 patients r and omized to trophic and the 102 patients r and omized to full-energy nutrition . At enrollment , patients had a mean Acute Physiology and Chronic Health Evaluation II score of 26.9 and a Pao2/Fio2 ratio of 182 and 38 % were in shock . Both groups received similar duration s of enteral nutrition ( 5.5 vs. 5.1 days ; p = .51 ) . The trophic group received an average of 15.8 % ± 11 % of goal calories daily through day 6 compared to 74.8 % ± 38.5 % ( p < .001 ) for the full-energy group . Both groups had a median of 23.0 ventilator-free days ( p = .90 ) and a median of 21.0 intensive-care-unit-free days ( p = .64 ) . Mortality to hospital discharge was 22.4 % for the trophic group vs. 19.6 % for the full-energy group ( p = .62 ) . In the first 6 days , the trophic group had trends for less diarrhea ( 19 % vs. 24 % of feeding days ; p = .08 ) and significantly fewer episodes of elevated gastric residual volumes ( 2 % vs. 8 % of feeding days ; p < .001 ) . Conclusion : Initial troph
Output:
| In conclusion , hypocaloric enteral nutrition had no significantly different effects on morbidity and mortality in critically ill patients when compared with full-energy nutrition . |
MS211653 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Some observational studies suggest that the use of pulmonary-artery catheters to guide therapy is associated with increased mortality . METHODS We performed a r and omized trial comparing goal -directed therapy guided by a pulmonary-artery catheter with st and ard care without the use of a pulmonary-artery catheter . The subjects were high-risk patients 60 years of age or older , with American Society of Anesthesiologists ( ASA ) class III or IV risk , who were scheduled for urgent or elective major surgery , followed by a stay in an intensive care unit . Outcomes were adjudicated by observers who were unaware of the treatment-group assignments . The primary outcome was in-hospital mortality from any cause . RESULTS Of 3803 eligible patients , 1994 ( 52.4 percent ) underwent r and omization . The base-line characteristics of the two treatment groups were similar . A total of 77 of 997 patients who underwent surgery without the use of a pulmonary-artery catheter ( 7.7 percent ) died in the hospital , as compared with 78 of 997 patients in whom a pulmonary-artery catheter was used ( 7.8 percent)--a difference of 0.1 percentage point ( 95 percent confidence interval , -2.3 to 2.5 ) . There was a higher rate of pulmonary embolism in the catheter group than in the st and ard-care group ( 8 events vs. 0 events , P=0.004 ) . The survival rates at 6 months among patients in the st and ard-care and catheter groups were 88.1 and 87.4 percent , respectively ( difference , -0.7 percentage point [ 95 percent confidence interval , -3.6 to 2.2 ] ; negative survival differences favor st and ard care ) ; at 12 months , the rates were 83.9 and 83.0 percent , respectively ( difference , -0.9 percentage point [ 95 percent confidence interval , -4.3 to 2.4 ] ) . The median hospital stay was 10 days in each group . CONCLUSIONS We found no benefit to therapy directed by pulmonary-artery catheter over st and ard care in elderly , high-risk surgical patients requiring intensive care A system has been constructed to evaluate the design , implementation , and analysis of r and omized control trials ( RCT ) . The degree of quadruple blinding ( the r and omization process , the physicians and patients as to therapy , and the physicians as to ongoing results ) is considered to be the most important aspect of any trial . The analytic techniques are scored with the same emphasis as is placed on the control of bias in the planning and implementation of the studies . Description of the patient and treatment material s and the measurement of various controls of quality have less weight . An index of quality of a RCT is proposed with its pros and cons . If published papers were to approximate these principles , there would be a marked improvement in the quality of r and omized control trials . Finally , a reasonable st and ard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials Introduction Little is known about mortality rates following general surgical procedures in the United Kingdom . Deaths are most common in the ' high-risk ' surgical population consisting mainly of older patients , with coexisting medical disease , who undergo major surgery . Only limited data are presently available to describe this population . The aim of the present study was to estimate the size of the high-risk general surgical population and to describe the outcome and intensive care unit ( ICU ) re source use . Methods Data on inpatient general surgical procedures and ICU admissions in 94 National Health Service hospitals between January 1999 and October 2004 were extracted from the Intensive Care National Audit & Research Centre data base and the CHKS data base . High-risk surgical procedures were defined prospect ively as those for which the mortality rate was 5 % or greater . Results There were 4,117,727 surgical procedures ; 2,893,432 were elective ( 12,704 deaths ; 0.44 % ) and 1,224,295 were emergencies ( 65,674 deaths ; 5.4 % ) . A high-risk population of 513,924 patients was identified ( 63,340 deaths ; 12.3 % ) , which accounted for 83.8 % of deaths but for only 12.5 % of procedures . This population had a prolonged hospital stay ( median , 16 days ; interquartile range , 9–29 days ) . There were 59,424 ICU admissions ( 11,398 deaths ; 19 % ) . Among admissions directly to the ICU following surgery , there were 31,633 elective admissions with 3,199 deaths ( 10.1 % ) and 24,764 emergency admissions with 7,084 deaths ( 28.6 % ) . The ICU stays were short ( median , 1.6 days ; interquartile range , 0.8–3.7 days ) but hospital admissions for those admitted to the ICU were prolonged ( median , 16 days ; interquartile range , 10–30 days ) . Among the ICU population , 40.8 % of deaths occurred after the initial discharge from the ICU . The highest mortality rate ( 39 % ) occurred in the population admitted to the ICU following initial postoperative care on a st and ard ward . Conclusion A large high-risk surgical population accounts for 12.5 % of surgical procedures but for more than 80 % of deaths . Despite high mortality rates , fewer than 15 % of these patients are admitted to the ICU BACKGROUND A prospect i ve , r and omized controlled trial comparing conventional intraoperative fluid management with two differing methods of invasive haemodynamic monitoring to optimize intraoperative fluid therapy , in patients undergoing proximal femoral fracture repair under general anaesthesia . METHODS Ninety patients r and omized to three groups ; conventional intraoperative fluid management ( Gp CON , n=29 ) , and two groups receiving additional repeated colloid fluid challenges guided by central venous pressure ( Gp CVP , n=31 ) or oesophageal Doppler ultrasonography ( Gp DOP , n=30 ) . Primary outcome measures were time to medical fitness to discharge , hospital stay and postoperative morbidity . RESULTS The fluid challenge result ed in significantly greater perioperative changes in central venous pressure between Gp CVP and Gp CON ( mean 5 ( 95 % confidence interval 3 - 7 ) mm Hg ) ( P<0.0001 ) . Important perioperative changes were also shown in Gp DOP with increases of 49.4 ms ( 19.7 - 79.1 ms ) in the corrected flow time , 13.5 ml ( 7.4 - 19.6 ml ) in stroke volume , and 0.9 ( 0.49 - 1.39 ) litre min(-1 ) in cardiac output . As a result , fewer patients in Gp CVP and Gp DOP experienced severe intraoperative hypotension ( Gp CON 28 % ( 8/29 ) , Gp CVP 9 % ( 3/31 ) , Gp DOP 7 % ( 2/30 ) , P=0.048 ( chi-squared , 2 degrees of freedom ( df ) . No differences were seen between the three groups when major morbidity and mortality were combined , P=0.24 ( chi-squared , 2 df ) . Postoperative recovery for survivors , as defined by time to be deemed medically fit for discharge , was significantly faster , in comparison with Gp CON , in both the Gp CVP ( 10 vs 14 ( 95 % confidence interval 8 - 12 vs 12 - 17 ) days , P=0.008 ( t-test ) ) , and Gp DOP ( 8 vs 14 ( 95 % confidence interval 6 - 12 vs 12 - 17 ) days , P=0.023 ( t-test ) . There were no significant differences between groups , for survivors , with respect to acute orthopaedic hospital and total hospital stay . CONCLUSIONS Invasive intraoperative haemodynamic monitoring with fluid challenges during repair of femoral fracture under general anaesthetic shortens time to being medically fit for discharge Organ dysfunction and multiple organ failure are the main causes of prolonged hospital stay after cardiac surgery , which increases re source use and health care costs . Increased levels of oxygen delivery and consumption are associated with improved outcome in different groups of postoperative patients . Cardiac surgical patients are at risk of inadequate perioperative oxygen delivery caused by extracorporeal circulation and limited cardiovascular reserves . The purpose of our study was to test whether increasing oxygen delivery immediately after cardiac surgery would shorten hospital and intensive care unit ( ICU ) stay . Four hundred three elective cardiac surgical patients were enrolled in the study and r and omly assigned to either the control or the protocol group . Goals of the protocol group were to maintain Svo2 > 70 % and lactate concentration ≤2.0 mmol/L from admission to the ICU and up to 8 h thereafter . Hemodynamics , oxygen transport data , and organ dysfunctions were recorded . The median hos-pital stay was shorter in the protocol group ( 6 vs 7 days , P < 0.05 ) , and patients were discharged faster from the hospital than those in the control group ( P < 0.05 ) . Discharge from the ICU was similar between groups ( P = 0.8 ) . Morbidity was less frequent at the time of hospital discharge in the protocol group ( 1.1 % vs 6.1 % , P < 0.01 ) . Increasing oxygen delivery to achieve normal Svo2 values and lactate concentration during the immediate postoperative period after cardiac surgery can shorten the length of hospital stay . Implication s Health care economics has challenged clinicians to reduce costs and improve re source use in cardiac surgery and anesthesia in a patient population increasing in age and in severity of disease . Optimizing cardiovascular function to maintain adequate oxygen delivery during the immediate postoperative period after cardiac surgery can decrease morbidity and reduce length of hospital stay Objective To evaluate the effects of maximizing the oxygen delivery on morbidity and mortality in patients > 60 yrs of age and /or with chronic diseases of vital organs who underwent major elective surgery . Design Prospect i ve , r and omized , controlled trial . Setting A 24-bed general intensive care unit of a teaching hospital . Patients Thirty-seven high-risk patients who underwent major surgery . Interventions The hemodynamic and oxygen transport variables and outcomes in 18 patients ( control group ) treated to maintain normal values of oxygen delivery were compared with 19 patients ( protocol group ) treated to maintain “ supranormal ” values . Therapy in both groups consisted of volume expansion and , when necessary , dobutamine to reach target values , during the surgery and 24 hrs postoperatively . Measurements and Main Results We interrupted the study because of a significant difference in the 60-day mortality rate . The mortality rate in the control group was significantly higher when compared with the protocol group ( 9/18 [ 50 % ] vs. 3/19 [ 15.7 % ] , p < .05 ) . The prevalence of clinical and infectious complications was higher in the control group than in the protocol group ( 67 % and 31 % respectively ; relative risk , 0.47 ; 95 % confidence interval , 0.226–0.991;p < .05 ) and there was a trend toward more severe organ dysfunction in nonachievers patients ( 17/24 [ 71 % ] vs. 6/13 [ 46 % ] , relative risk , 0.65 ; 95 % confidence interval , 0.343–1.237 ; NS ) . Conclusion Older patients with existing cardiorespiratory illness undergoing major surgery have a reduced morbidity and mortality when dobutamine is used to maximize oxygen transport Background Intraoperative hypovolemia is common and is a potential cause of organ dysfunction , increased postoperative morbidity , length of hospital stay , and death . The objective of this prospect i ve , r and omized study was to assess the effect of goal -directed intraoperative fluid administration on length of postoperative hospital stay . Methods One hundred patients who were to undergo major elective surgery with an anticipated blood loss greater than 500 ml were r and omly assigned to a control group ( n = 50 ) that received st and ard intraoperative care or to a protocol group ( n = 50 ) that , in addition , received intraoperative plasma volume expansion guided by the esophageal Doppler monitor to maintain maximal stroke volume . Length of postoperative hospital stay and postoperative surgical morbidity were assessed . Results Groups were similar with respect to demographics , surgical procedures , and baseline hemodynamic variables . The protocol group had a significantly higher stroke volume and cardiac output at the end of surgery compared with the control group . Patients in the protocol group had a shorter duration of hospital stay compared with the control group : 5 ± 3 versus 7 ± 3 days ( mean ± SD ) , with a median of 6 versus 7 days , respectively ( P = 0.03 ) . These patients also tolerated oral intake of solid food earlier than the control group : 3 ± 0.5 versus 4.7 ± 0.5 days ( mean ± SD ) , with a median of 3 versus 5 days , respectively ( P = 0.01 ) . Conclusions Goal -directed intraoperative fluid administration results in earlier return to bowel function , lower incidence of postoperative nausea and vomiting , and decrease in length of postoperative hospital stay Objective To test the hypothesis that dopexamine reduces postoperative mortality and morbidity in high-risk , major abdominal surgery patients , when given to fluid
Output:
| : In high-risk surgical patients , the use of a hemodynamic protocol to maintain tissue perfusion decreased mortality and postoperative organ failure .
Monitoring cardiac output calculating oxygen transport and consumption helped to guide therapy . |
MS211654 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The aim of this study was to assess whether a combination of gemcitabine ( GEM ) with either paclitaxel ( PTX ) or vinorelbine ( VNR ) could be more effective than GEM or PTX alone in elderly or unfit advanced non-small-cell lung cancer ( NSCLC ) patients . A total of 264 NSCLC patients aged > 70 years with ECOG performance status (PS)⩽2 , or younger with PS=2 , were r and omly treated with : GEM 1200 mg m−2 on days 1 , 8 and 15 every 28 days ; PTX 100 mg m−2 on days 1 , 8 and 15 every 28 days ; GEM 1000 mg m−2 plus PTX 80 mg m−2 ( GT ) on days 1 and 8 every 21 days ; GEM 1000 mg m−2 plus VNR 25 mg m−2 ( GV ) on days 1 and 8 every 21 days . In all arms , an intra- patients dose escalation was applied over the first three courses , provided that no toxicity of WHO grade ⩾2 had previously occurred . At present time , 217 ( 82 % ) patients had died . The median ( months ) and 1-year survival probability were 5.1 and 29 % for GEM , 6.4 and 25 % for PTX , 9.2 and 44 % for GT , and 9.7 and 32 % for GV . Multivariate analysis showed that PS⩽1 ( hazard ratio (HR)=0.67 ; 95 % CI 0.51–0.90 ) , and doublet treatments ( HR=0.76 ; 95 % CI 0.59–0.99 ) were significantly associated with longer survival . Doublets produced no more toxicity than single agents . GT should be considered a reference regimen for elderly NSCLC patients with PS⩽1 PURPOSE The objective of this trial was to compare two vinorelbine-based doublets with carboplatin ( CBDCA-VC ) or with gemcitabine ( VG ) in patients with stage IIIB-IV non-small cell lung cancer ( NSCLC ) . PATIENTS AND METHODS A total of 316 patients with advanced NSCLC previously untreated were r and omized to either vinorelbine 30 mg/m(2 ) D1,8 with carboplatin AUC 5 D1 ( VC ) or vinorelbine 25mg/m(2 ) with gemcitabine ( VG ) 1000 mg/m(2 ) both given D1,8 every 3 weeks . The primary endpoint was response rate with secondary parameters being survival ( OS ) , progression-free survival ( PFS ) , tolerance and clinical benefit . RESULTS The median number of cycles was four in each arm with a total of 1268 cycles . The objective response ( OR ) on intent-to-treat was 20.8 % in VC and 28 % in VG ( p=0.15 ) . Median PFS was 3.9 months in VC and 4.4 months ( mo ) in VG ( p=0.18 ) . Median survival was significantly longer ( p=0.01 ) for VG with 11.5 mo compared to 8.6 mo in VC with 1 year survival at 48.9 and 34.4 % , respectively . Tolerance was better in the VG arm as compared to the VC patients . Four toxic deaths were recorded in the VC group . Clinical benefit response rate was 32.4 % compared to 40.9 % in 111 and 110 evaluable patients in VC and VG , respectively . CONCLUSION VG compared to VC result ed in a similar overall response rate , favourable median survival and a better toxicity profile . For non-cisplatin-based chemotherapy , VG is a useful alternative This r and omised multicentre trial was conducted to establish the optimal duration of palliative chemotherapy in advanced non-small-cell lung cancer ( NSCLC ) . We compared a policy of three vs six courses of new-generation platinum-based combination chemotherapy with regard to effects on quality of life ( QoL ) and survival . Patients with stage IIIB or IV NSCLC and WHO performance status ( PS ) 0–2 were r and omised to receive three ( C3 ) or six ( C6 ) courses of carboplatin ( area under the curve ( AUC ) 4 , Chatelut 's formula , equivalent to Calvert 's AUC 5 ) on day 1 and vinorelbine 25 mg m−2 on days 1 and 8 of a 3-week cycle . Key end points were QoL at 18 weeks , measured with EORTC Quality of Life Question naire (QLQ)-C30 and QLQ-LC13 , and overall survival . Secondary end points were progression-free survival and need of palliative radiotherapy . Two hundred and ninety-seven patients were r and omised ( C3 150 , C6 147 ) . Their median age was 65 years , 30 % had PS 2 and 76 % stage IV disease . Seventy-eight and 54 % of C3 and C6 patients , respectively , completed all scheduled chemotherapy courses . Compliance with QoL question naires was 88 % . There were no significant group differences in global QoL , pain or fatigue up to 26 weeks . The dyspnoea palliation rate was lower in the C3 arm at 18 and 26 weeks ( P<0.05 ) , but this finding was inconsistent across different methods of analysis . Median survival in the C3 group was 28 vs 32 weeks in the C6 group ( P=0.75 , HR 1.04 , 95 % CI 0.82–1.31 ) . One- and 2-year survival rates were 25 and 9 % vs 25 and 5 % in the C3 and C6 arm , respectively . Median progression-free survival was 16 and 21 weeks in the C3 and C6 groups , respectively ( P=0.21 , HR 0.86 , 95 % CI 0.68–1.08 ) . In conclusion , palliative chemotherapy with carboplatin and vinorelbine beyond three courses conveys no survival or consistent QoL benefits in advanced NSCLC To determine a st and ard combination chemotherapy for patients with advanced non-small-cell lung cancer ( NSCLC ) , we conducted a phase III trial of irinotecan ( CPT-11 ) to test the hypotheses that CPT-11+cisplatin is superior to cisplatin+vindesine and that CPT-11 monotherapy is not inferior to cisplatin+vindesine . A total of 398 patients with previously untreated NSCLC were r and omised to receive cisplatin+CPT-11 ( CPT-P ) , cisplatin+vindesine ( VDS-P ) or CPT-11 alone ( CPT ) . In the CPT-P arm , CPT-11 60 mg m−2 was administered on days 1 , 8 and 15 , and cisplatin 80 mg m−2 was administered on day 1 . In the VDS-P arm , cisplatin 80 mg m−2 was administered on day 1 , and vindesine 3 mg m−2 was administered on days 1 , 8 and 15 . In the CPT arm , CPT-11 100 mg m−2 was administered on days 1 , 8 and 15 . The median survival time was 50.0 weeks for patients on CPT-P , 45.6 weeks for those on VDS-P and 46.0 weeks for those on CPT ( P=0.115 , CPT-P vs VDS-P ; P=0.089 , CPT vs VDS-P ) , and the hazard ratio was 0.85 ( 95 % confidence interval ( CI ) : 0.65–1.11 ) for CPT-P vs VDS-P and 0.83 ( 0.64–1.09 ) for CPT vs VDS-P. The response rate was 43.7 % for patients on CPT-P , 31.7 % for those on VDS-P and 20.5 % for those on CPT . Major adverse reactions were grade 4 neutropenia observed in 37 , 54 and 8 % of the patients on CPT-P , VDS-P and CPT , respectively ; and grade s 3 and 4 diarrhoea observed in 12 , 3 and 15 % of the patients , respectively . CPT-P therapy produces comparable survival to VDS-P in patients with advanced NSCLC . CPT-11 monotherapy is not inferior to VDS-P in terms of survival . The CPT-11-containing regimen is one of the most efficacious and well tolerated in the treatment of advanced NSCLC OBJECTIVE To determine , in stage IV non-small-cell lung cancer ( NSCLC ) , if the combination of gemcitabine-a new active drug-with ifosfamide ( IG ) or with the cisplatin-carboplatin association ( CCG ) will improve survival ( primary end point ) in comparison with a first-generation regimen , cisplatin-carboplatin-ifosfamide ( CCI ) . PATIENTS AND METHODS A total of 284 chemotherapy-naïve patients with metastatic NSCLC were r and omised . Four were ineligible and 16 were not assessable for responses . Cisplatin was given at 60 mg/m2 on day 1 , carboplatin AUC 3 mg.min/ml on day 1 , ifosfamide 4.5 g/m2 on day 1 and gemcitabine 1 g/m2 on days 1 , 8 and 15 . Courses were repeated every 4 weeks . Response was assessed after three courses and chemotherapy was continued in responding patients until best response . There were 94 eligible patients in the CCI arm , 92 in CCG and 94 in the IG arm . RESULTS The objective response rates for CCI , CCG and IG were 23 % [ 95 % confidence interval ( CI ) 15 % to 32 % ] , 29 % ( 95 % CI 20 % to 39 % ) and 25 % ( 95 % CI 16 % to 33 % ) , respectively ( P = 0.61 ) . Median survival time was 24 , 34 and 30 weeks , respectively ( P = 0.20 ) . One-year survival was 23 , 33 and 35 % , and 2-year survival was 11 , 14 and 17 % , respectively . In some subgroups ( older patients , women ) , there was a significant survival advantage for CCG and IG compared with CCI . Toxicity was tolerable : severe alopecia was less frequent in the CCG arm , and IG was associated with significantly more thrombopenia while CCG was associated with more leucopenia . CONCLUSION In stage IV NSCLC , treatment with regimens including the new drug gemcitabine were associated with a better but not statistically significant observed survival compared with a classical first-generation cisplatin-containing regimen . The non-platinum combination of gemcitabine was as effective as its combination with platinum The aim of this study was to compare the efficacy of single‐agent weekly docetaxel with the combination of docetaxel and gemcitabine in elderly and /or poor performance status patients with advanced nonsmall cell lung cancer ( NSCLC ) PURPOSE The purpose of this study was to determine whether the addition of the epidermal growth factor receptor tyrosine kinase inhibitor gefitinib ( Iressa , ZD1839 ; AstraZeneca , Wilmington , DE ) to st and ard first-line gemcitabine and cisplatin provides clinical benefit over gemcitabine and cisplatin alone in patients with advanced or metastatic non-small-cell lung cancer ( NSCLC ) . Gefitinib has demonstrated encouraging efficacy in advanced NSCLC in phase II trials in pretreated patients , and a phase I trial of gefitinib in combination with gemcitabine and cisplatin showed favorable tolerability . PATIENTS AND METHODS This was a phase III r and omized , double-blind , placebo-controlled , multicenter trial in chemotherapy-naive patients with unresectable stage III or IV NSCLC . All patients received up to six cycles of chemotherapy ( cisplatin 80 mg/m(2 ) on day 1 and gemcitabine 1,250 mg/m(2 ) on days 1 and 8 of the 3-week cycle ) plus either gefitinib 500 mg/d , gefitinib 250 mg/d , or placebo . Daily gefitinib or placebo was continued until disease progression . End points included overall survival ( primary ) , time to progression , response rates , and safety evaluation . RESULTS A total of 1,093 patients were enrolled . There was no difference in efficacy end points between the treatment groups : for the gefitinib 500 mg/d , gefitinib 250 mg/d , and placebo groups , respectively , median survival times were 9.9 , 9.9 , and 10.9 months ( global ordered log-rank [ GOLrank ] P = .4560 ) , median times to progression were 5.5 , 5.8 , and 6.0 months ( GOLrank ; P = .7633 ) , and response rates were 49.7 % , 50.3 % , and 44.8 % . No significant unexpected adverse events were seen . CONCLUSION Gefitinib in combination with gemcitabine and cisplatin in chemotherapy-naive patients with advanced NSCLC did
Output:
| R and omized studies suggest that platinum-based doublets ( platinum plus new agent ) are the st and ard of care for first-line systemic therapy .
No one new agent is clearly superior for use in combination with a platinum agent .
The survival advantage of platinum-based doublets over nonplatinum combinations or older combinations is modest .
The addition of bevacizumab to carboplatin and paclitaxel has shown improved survival , although multiple exclusion criteria limit the applicability of these data to a subset of patients .
In patients at least 70 years of age or with Eastern Collaborative Oncology Group performance status 2 , a new single agent is an alternative .
Treatment beyond four to six cycles impedes quality of life without prolonging life .
Emerging data suggest that the choice of chemotherapy agent may be influenced by histologic subtype .
In NSCLC , a combination of a platinum agent plus a new agent continues to be the st and ard of care . |
MS211655 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective Mechanical factors , in particular increased medial knee joint load , are believed to be important in the structural progression of knee osteoarthritis . This study evaluated the relationship of medial knee load during walking to indices of structural disease progression , measured on MRI , in people with medial knee osteoarthritis . Methods A longitudinal cohort design utilising a subset of participants ( n=144 , 72 % ) enrolled in a r and omised controlled trial of lateral wedge insoles was employed . Medial knee load parameters including the peak knee adduction moment ( KAM ) and the KAM impulse were measured at baseline using three-dimensional gait analysis during walking . MRI at baseline and at 12 months was used to assess structural indices . Multiple regression with adjustment for covariates assessed the relationship between medial knee load parameters and the annual change in medial tibial cartilage volume . Binary logistic regression was used for the dichotomous variables of progression of medial tibiofemoral cartilage defects and bone marrow lesions ( BML ) . Results A higher KAM impulse , but not peak KAM , at baseline was independently associated with greater loss of medial tibial cartilage volume over 12 months ( β=29.9 , 95 % CI 6.3 to 53.5 , p=0.01 ) . No significant relationships were seen between medial knee load parameters and the progression of medial tibiofemoral cartilage defects or BML . Conclusion This study suggests knee loading , in particular the KAM impulse , may be a risk factor for loss of medial tibial cartilage volume . As knee load is modifiable , load-modifying treatments may potentially slow disease progression Anterior cruciate ligament ( ACL ) injury can result in failure to return to pre-injury activity levels and future osteoarthritis predisposition . Single leg hop is used in late rehabilitation to evaluate recovery and inform treatment but biomechanical underst and ing of this activity is insufficient . This study investigated single leg hop for distance aim ing to evaluate if ACL patients had recovered : ( 1 ) l and ing strategies and ( 2 ) medio-lateral knee control . We hypothesized that patients with reconstructive surgery ( ACLR ) would have more similar l and ing strategies and knee control to healthy controls than patients treated conservatively ( ACLD ) . 16 ACLD and 23 ACLR subjects were compared to 20 healthy controls ( CONT ) . Kinematic and ground reaction force data were collected while subjects hopped their maximum distance . The main output parameters were hop distance , peak knee flexor angles and extensor moments and Fluency ( a measure introduced to represent medio-lateral knee control ) . Statistical differences between ACL and control groups were analyzed using a general linear model univariate analysis , with COM velocity prior to l and ing as covariate . Hop distance was the smallest for ACLD and largest for CONT ( p<0.001 ; ACLD 57.1±14.1 ; ACLR 75.1±17.8 ; CONT 77.7±14.07 % height ) . ACLR used a similar kinematic strategy to CONT , but had a reduced peak knee extensor moment ( p<0.001 ; ACLD 0.32±0.14 ; ACLR 0.31±0.16 ; CONT 0.42±0.13 BW.height ) . Fluency was reduced in both ACLD and ACLR ( p=0.006 ; ACLD 0.13±0.34 ; ACLR 0.14±0.34 ; CONT 0.17±0.41 s ) . Clinical practice uses hopping distance to evaluate ACL patients ' recovery . This study demonstrated that aspects such as movement strategies and knee control need to be evaluated OBJECTIVE To determine how chronic anterior cruciate ligament deficient and surgically repaired subjects react to unexpected forward perturbations during gait as compared to healthy controls . DESIGN Gait testing of 10 chronic anterior cruciate ligament deficient subjects prior to and three months following reconstructive surgery , and 10 uninjured controls . BACKGROUND The ability of an anterior cruciate ligament injured individual to react and maintain equilibrium during gait perturbations is critical for the prevention of reinjury . No studies have investigated how these individuals respond to unexpected perturbations during normal gait . METHODS An unexpected forward perturbation was induced upon heel strike using a force plate capable of translational movement . RESULTS Prior to surgery , the anterior cruciate ligament subjects exhibited a greater knee extensor moment in response to the perturbation compared to healthy controls . Following surgery , the anterior cruciate ligament injured subjects exhibited a static knee position and a sustained knee extensor moment throughout stance in response to the perturbation as compared to controls . CONCLUSIONS These data suggest that chronic anterior cruciate ligament deficient subjects rely heavily on knee extensor musculature to prevent collapse in response to an unexpected perturbation . This same reactive response was more pronounced 3 months following surgery . RELEVANCE The results suggest that , prior to and following surgery , chronic anterior cruciate ligament injured subjects respond differently than healthy controls to an unexpected perturbation during gait . Anterior cruciate ligament injured or repaired subjects do not reduce or avoid vigorous contraction of the quadriceps muscles when responding to gait perturbations Reports that knee cartilage health is sensitive to kinematic changes , combined with reports of extension loss following ACL reconstruction , underscores the importance of restoring ambulatory knee extension in the context of preventing premature osteoarthritis . The purpose of this study was to test the relationship between individual variations in peak knee extension at heel-strike of walking and the anterior-posterior location of thickest cartilage in the medial and lateral femoral condyles of healthy contralateral and ACL reconstructed knees . In vivo gait analysis and knee MR images were collected from 29 subjects approximately 2 years after unilateral ACL reconstruction . Knee extension was measured at heel-strike of walking and 3-D femoral cartilage thickness models were reconstructed from MR images . The ACL reconstructed knees had significantly reduced knee extension ( -1.5±4.2 ° ) relative to the contralateral knees ( -4.6±3.4 ° ) at heel-strike of walking but did not have side-to-side differences in the anterior-posterior location or magnitude of thickest medial and lateral femoral cartilage . The anterior-posterior location of the thickest medial femoral cartilage was correlated with knee extension at heel-strike in both the healthy contralateral ( R(2)=0.356 , p<0.001 ) and reconstructed ( R(2)=0.234 , p=0.008 ) knees . These results suggest that ACL reconstruction can impair terminal extension at periods of ambulatory loading known to be related to cartilage morphology in healthy joints . The fact that the femoral cartilage thickness distribution had not changed at 2 years post-op , even in the subset of subjects with extension loss , suggests that loads may be shifted to thinner cartilage regions , which could have important implication s on long-term joint health OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity Abstract The aim of this study is to analyse the changes in select gait parameters following anterior cruciate ligament ( ACL ) reconstruction . The study was performed on 15 subjects who underwent ACL reconstruction by the bone-patellar tendon-bone technique . Gait analysis was performed using the Elite three-dimensional ( 3D ) optoelectronic system ( BTS ) , a Kistler force platform and the Telemg telemetric electromyograph ( BTS ) . Kinematic data were recorded for the principal lower limb joints ( hip , knee and ankle ) . The examined muscles include vastus lateralis , rectus femoris , biceps femoris and semitendinosus . The results obtained from the operated subjects were compared with those of 10 untreated subjects and 5 subjects without ACL damage . In the operated subjects the knee joint angular values regained a normal flexion pattern for the injured limb during the stance phase . The analysis of joint moments shows : ( a ) sagittal plane : recovery of the knee flexion moment at loading response and during preswing ; ( b ) frontal plane : recovery of the normal patterns for both hip and knee adduction-abduction moments during the entire stance phase . The examination of ground reaction forces reveals the recovery of frontal component features . The EMG traces show the normal biphasic pattern for the operated subjects as compared to the untreated subjects . The results suggest that the gait parameters shift towards normal value patterns OBJECTIVE The adduction moment at the knee during gait is the primary determinant of medial-to-lateral load distribution . If the adduction moment contributes to progression of osteoarthritis ( OA ) , then patients with advanced medial tibiofemoral OA should have higher adduction moments . The present study was undertaken to investigate the hypothesis that the adduction moment normalized for weight and height is associated with medial tibiofemoral OA disease severity after controlling for age , sex , and pain level , and to examine the correlation of serum hyaluronan ( HA ) level with disease severity and with the adduction moment in a subset of patients . METHODS Fifty-four patients with medial tibiofemoral OA underwent gait analysis and radiographic evaluation . Disease severity was assessed using the Kellgren-Lawrence ( K-L ) grade and medial joint space width . In a subset of 23 patients with available sera , HA was quantified by s and wich enzyme-linked immunosorbent assay . Pearson correlations , a r and om effects model , and multivariate regression models were used . RESULTS The adduction moment correlated with the K-L grade in the left and right knees ( r = 0.68 and r = 0.60 , respectively ) , and with joint space width in the left and right knees ( r = -0.45 and r = -0.47 , respectively ) . The relationship persisted after controlling for age , sex , and severity of pain . The partial correlation between K-L grade and adduction moment was 0.71 in the left knees and 0.61 in the right knees . For every 1.0-unit increase in adduction moment , there was a 0.63-mm decrease in joint space width . In the subset of patients in whom serum HA levels were measured , HA levels correlated with medial joint space width ( r = -0.55 ) , but not with the adduction moment . CONCLUSION There is a significant relationship between the adduction moment and OA disease severity . Serum HA levels correlate with joint space width but not with the adduction moment . Longitudinal studies will be necessary to determine the contribution of the adduction moment , and its contribution in conjunction with metabolic markers , to progression of medial tibiofemoral OA OBJECTIVES To examine the effects of 2 gait retraining protocol s on the gait patterns of patients with bone-patellar tendon-bone anterior cruciate ligament ( ACL ) reconstruction . DESIGN R and omized control , repeated- measures design . SETTING Private orthopedic center and research facility . PARTICIPANTS Sixteen patients with bone-patellar tendon-bone ACL reconstruction , r and omly subdivided into 2 groups ( group 1 , n=8 ; group 2 , n=8 ) , and a healthy control group of 8 subjects . INTERVENTION The 16 subjects with ACL reconstruction were r and omly assigned to 2 different gait retraining protocol s over a 6-week training interval : ( 1 ) . a protocol using a predicted stride frequency calculated from the resonant frequency of a force-driven harmonic oscillator ( FDHO ) model or ( 2 ) . a protocol using the preferred stride frequency ( PSF ) . MAIN OUTCOME MEASURES Gait analyses examining the lower-extremity kinematic
Output:
| Sagittal plane biomechanics , rather than the knee adduction moment , appear to be more relevant post-ACLR .
Better underst and ing of sagittal plane biomechanics is necessary for optimal post-operative recovery , and to potentially prevent early onset and progression of knee OA after ACLR . |
MS211656 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To compare the effects of night-only to full-time splint wear instructions on symptoms , function , and impairment in carpal tunnel syndrome ( CTS ) . DESIGN R and omized clinical trial with 6-week follow-up . SETTING Veterans Administration Medical Center , outpatient clinic . SUBJECTS Out patients with untreated CTS were consecutively recruited from our electrodiagnostics lab . Twenty-one patients ( 30 h and s ) were enrolled , and 17 patients ( 24 h and s ) completed the study . INTERVENTIONS Thermoplastic , custom-molded , neutral wrist splints with subjects receiving either full-time or night-only wear instructions . OUTCOME MEASURES Symptoms and functional deficits were measured by Levine 's self-administered question naire , and physiologic impairment was measured by median nerve sensory and motor distal latency . COMPLIANCE AND CROSSOVER : Almost all ( 92 % ) of the combined sample reported frequent splint use , but their adherence to specific wearing instructions was limited . A majority ( 73 % ) of the full-time group reported splint wear less than one half of waking hours , and some ( 23 % ) of the night-only group reported occasional daytime wear . Despite this tendency for treatment crossover , the two treatment groups differed in daytime wear as intended ( chi2 analysis , p = .004 ) . RESULTS The combined sample improved in three of four outcome measures : sensory distal latency ( mean = .28msec , st and ard deviation [ SD ] = .37 , p = .004 ) , symptom severity ( mean = .64 , SD = .46 , p = .0001 ) , and functional deficits ( mean = .49 , SD = .51 , p = .0001 ) . Severity of CTS was a factor only in sensory distal latency improvement ( more improvement in severe CTS ) . Subjects receiving full-time wear instructions showed superior distal latency improvement , both motor ( .35 vs -.07msec , p = .04 ) and sensory ( .46 vs . 13msec , p = .05 ) when compared with subjects receiving night-only wear instructions . CONCLUSIONS This study provides added scientific evidence to support the efficacy of neutral wrist splints in CTS and suggests that physiologic improvement is best with full-time splint wear instructions This study was design ed to compare the efficacy of ultrasound and laser treatment for mild to moderate idiopathic carpal tunnel syndrome . Ninety h and s in 50 consecutive patients with carpal tunnel syndrome confirmed by electromyography were allocated r and omly in two experimental groups . One group received ultrasound therapy and the other group received low level laser therapy . Ultrasound treatment ( 1 MHz , 1.0 W/cm(2 ) , pulse 1:4 , 15 min/session ) and low level laser therapy ( 9 joules , 830 nm infrared laser at five points ) were applied to the carpal tunnel for 15 daily treatment sessions ( 5 sessions/week ) . Measurements were performed before and after treatment and at follow up four weeks later , and included pain assessment by visual analogue scale ; electroneurographic measurement ( motor and sensory latency , motor and sensory action potential amplitude ) ; and pinch and grip strength . Improvement was significantly more pronounced in the ultrasound group than in low level laser therapy group for motor latency ( mean difference 0.8 m/s , 95 % CI 0.6 to 1.0 ) , motor action potential amplitude ( 2.0 mV , 95 % CI 0.9 to 3.1 ) , finger pinch strength ( 6.7 N , 95 % CI 5.0 to 8.2 ) , and pain relief ( 3.1 points on a 10-point scale , 95 % CI 2.5 to 3.7 ) . Effects were sustained in the follow-up period . Ultrasound treatment was more effective than laser therapy for treatment of carpal tunnel syndrome . Further study is needed to investigate the combination therapy effects of these treatments in carpal tunnel syndrome patients OBJECTIVE To investigate whether real or sham low-level laser therapy ( LLLT ) plus microamperes transcutaneous electric nerve stimulation ( TENS ) applied to acupuncture points significantly reduces pain in carpal tunnel syndrome ( CTS ) . DESIGN R and omized , double-blind , placebo-control , crossover trial . Patients and staff administered outcome measures blinded . SETTING Outpatient , university-affiliated Department of Veterans Affairs medical center . PARTICIPANTS Eleven mild to moderate CTS cases ( nerve conduction study , clinical examination ) who failed st and ard medical or surgical treatment for 3 to 30 months . INTERVENTION Patients received real and sham treatment series ( each for 3 - 4wk ) , in a r and omized order . Real treatments used red-beam laser ( continuous wave , 15mW , 632.8 nm ) on shallow acupuncture points on the affected h and , infrared laser ( pulsed , 9.4W , 904 nm ) on deeper points on upper extremity and cervical paraspinal areas , and microamps TENS on the affected wrist . Devices were painless , noninvasive , and produced no sensation whether they were real or sham . The h and was treated behind a hanging black curtain without the patient knowing if devices were on ( real ) or off ( sham ) . MAIN OUTCOME MEASURES McGill Pain Question naire ( MPQ ) score , sensory and motor latencies , and Phalen and Tinel signs . RESULTS Significant decreases in MPQ score , median nerve sensory latency , and Phalen and Tinel signs after the real treatment series but not after the sham treatment series . Patients could perform their previous work ( computer typist , h and yman ) and were stable for 1 to 3 years . CONCLUSIONS This new , conservative treatment was effective in treating CTS pain ; larger studies are recommended OBJECTIVE To compare the efficacy of conservative medical care with chiropractic care in the treatment of carpal tunnel syndrome . DESIGN Two-group , r and omized , single-blind trial with 9 wk of treatment and a 1-month follow-up interview . SETTING Wolfe-Harris Center for Clinical Studies at Northwestern College of Chiropractic in Bloomington , Minnesota . PATIENTS Ninety-one of 96 eligible subjects who reported symptoms that were confirmed by clinical exam and nerve conduction studies . INTERVENTIONS Interventions included ibuprofen ( 800 mg 3 times a day for 1 wk , 800 mg twice a day for 1 wk and 800 mg as needed to a maximum daily dose of 2400 mg for 7 wk ) and nocturnal wrist supports for medical treatment . Chiropractic treatment included manipulation of the soft tissues and bony joints of the upper extremities and spine ( three treatments/week for 2 wk , two treatments/week for 3 wk and one treatment/week for 4 wk ) , ultrasound over the carpal tunnel and nocturnal wrist supports . MAIN OUTCOME MEASURES Outcome measures were pre- and post assessment s of self-reported physical and mental distress , nerve conduction studies and vibrometry . RESULTS There was significant improvement in perceived comfort and function , nerve conduction and finger sensation overall , but no significant differences between groups in the efficacy of either treatment . CONCLUSIONS Carpal tunnel syndrome associated with median nerve demyelination but not axonal degeneration may be treated with commonly used components of conservative medical or chiropractic care Abstract Objective : To assess the efficacy of ultrasound treatment for mild to moderate idiopathic carpal tunnel syndrome . Design : R and omised , double blind , “ sham ” controlled trial with assessment s at baseline , after 2 weeks ' and 7 weeks ' treatment , and at a follow up assessment 6 months later ( 8 months after baseline evaluation ) . Setting : Outpatient clinic of a university department of physical medicine and rehabilitation in Vienna . Subjects : 45 patients with mild to moderate bilateral carpal tunnel syndrome as verified by electroneurography . Intervention : 20 sessions of ultrasound ( active ) treatment ( 1 MHz , 1.0 W/cm2 , pulsed mode 1:4 , 15 minutes per session ) applied to the area over the carpal tunnel of one wrist , and indistinguishable sham ultrasound treatment applied to the other . The first 10 treatments were performed daily ( 5 sessions/week ) ; 10 further treatments were twice weekly for 5 weeks . Main outcome measures : Score of subjective symptom ratings assessed by visual analogue scale ; electroneurographic measures ( for example , motor distal latency and sensory antidromic nerve conduction velocity ) . Results : Improvement was significantly more pronounced in actively treated than in sham treated wrists for both subjective symptoms ( P<0.001 , paired t test ) and electroneurographic variables ( motor distal latency P<0.001 , paired t test ; sensory antidromic nerve conduction velocity P<0.001 , paired t test ) . Effects were sustained at 6 months ' follow up . Conclusion : Results suggest there are satisfying short to medium term effects due to ultrasound treatment in patients with mild to moderate idiopathic carpal tunnel syndrome . Findings need to be confirmed , and ultrasound treatment will have to be compared with st and ard conservative and invasive treatment options . Key messages Chronic entrapment of the median nerve at the wrist ( the carpal tunnel syndrome ) is probably the most common peripheral nerve lesion No satisfactory conservative treatment is available at present Twenty sessions of ultrasound treatment show good short and medium term efficacy in patients with bilateral , mild to moderate forms of the carpal tunnel syndrome Optimal treatment schedules of ultrasound treatment alone or in combination with other non-surgical treatments await Objectives : To determine the efficacy of a two week and a four week course of oral steroids in the conservative treatment of carpal tunnel syndrome . Methods : 109 patients with carpal tunnel syndrome were r and omly divided into two treatment groups : ( 1 ) two weeks of prednisolone 20 mg daily followed by two weeks of prednisolone 10 mg daily ( n = 53 ) ; ( 2 ) two weeks of prednisolone 20 mg daily and two weeks of placebo ( n = 56 ) . A symptom question naire was used to rate the five major symptoms of carpal tunnel syndrome ( numbness , pain , weakness/clumsiness , tingling , and nocturnal awakening ) on a scale of 0 ( nil ) to 10 ( severe ) ; the result ing global symptom score was used to evaluate the efficacy of treatment . Assessment s were made at baseline and at one , three , six , nine , and 12 months . Electrodiagnosis was repeated at the end of the study to vali date improvement . Results : In an intention to treat analysis at the end of the study , improvement in the four week treatment group was achieved in 66.0 % of the patients after one month and in 49.0 % at the end of the study ; in the two week treatment group , the respective values were 48.2 % and 35.7 % . In the four week treatment group , 51 % were considered treatment failures ( including those lost to follow up , receiving surgery , or with mild or no improvement ) , compared with 64.3 % for the two week group . Though the percentage improvement was higher in the four week group , the difference did not reach a statistical significance . Persistence of improvement was 74.2 % in the four week group v 74.1 % in the two week group , suggesting no difference in the long term effect . Efficacy analysis showed no significant difference in global symptom score reduction between the two groups . Follow up electrodiagnosis showed significant improvement in all measured variables except for the amplitude of compound muscle action potentials . Conclusions : Short term low dose oral steroid are effective treatment for carpal tunnel syndrome . The dose of steroids and the duration treatment are not key determinants of efficacy Several studies have suggested that low-level laser therapy ( LLLT ) is effective in patients with carpal tunnel syndrome ( CTS ) . In a double-blind r and omized controlled trial of LLLT , 15 CTS patients , 34 to 67 years of age , were r and omly assigned to either the control group ( n = 8) or treatment group ( n = 7 ) . Both groups were treated three times per week for 5 weeks . Those in the treatment group received 860 nm galium/aluminum/arsenide laser at a dosage of 6 J/cm2 over the carpal tunnel , whereas those in the control group were treated with sham laser . The primary outcome measure was the Levine Carpal Tunnel Syndrome Question naire , and the secondary outcome measures were electrophysiological data and the Purdue pegboard test . All patients completed the study without adverse effects . There was a significant symptomatic improvement in both the control ( P = 0.034 ) and treatment ( P = 0.043 ) groups . However , there was no significant difference in any of the outcome measures between the two groups . Thus , LLLT is no more effective in the reduction of symptoms of CTS than is sham treatment The authors compared the effectiveness of low-dose , short-term oral prednisolone vs local methylprednisolone injection in a prospect i ve , double-blinded , parallel treatment study of carpal tunnel syndrome ( CTS ) . A single injection of 15 mg methylprednisolone result ed in significant improvement in global symptom scores over a 12-week period . This study demonstrated the superiority of local steroid injection to oral steroid in the treatment of CTS Çeliker R , Arslan Ş , İnanıcı F : Corticosteroid injection vs. nonsteroidal antiinflammatory drug and splinting in carpal tunnel syndrome . Am J Phys Med Rehabil 20
Output:
| Our review shows that : ( 1 ) locally injected steroids produce a significant but temporary improvement , ( 2 ) vitamin B6 is ineffective , ( 3 ) steroids are better than non-steroidal anti-inflammatory drugs ( NSAIDs ) and diuretics , but they can produce side-effects , ( 4 ) ultrasound is effective while laser therapy shows variable results , ( 5 ) exercise therapy is not effective , ( 6 ) splints are effective , especially if used full-time .
Conclusion : There is : ( 1 ) strong evidence ( level 1 ) on efficacy of local and oral steroids ; ( 2 ) moderate evidence ( level 2 ) that vitamin B6 is ineffective and splints are effective and ( 3 ) limited or conflicting evidence ( level 3 ) that NSAIDs , diuretics , yoga , laser and ultrasound are effective whereas exercise therapy and botulinum toxin B injection are ineffective |
MS211657 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Although a reduction has occurred in the use of antibiotics for upper respiratory tract infections , international evidence indicates that they continue to be used for these conditions.1 This is in spite of Cochrane review s indicating minimal or no benefit from antibiotics for sore throat , acute bronchitis , the common cold , and otitis media . This situation of potentially inappropriate prescribing prompted one commentator to suggest the use of delayed prescriptions ( also known as “ back-pocket , ” “ back-up , ” or “ as needed ” prescriptions).2 These are prescriptions written with a proviso that they not be used immediately and only if symptoms do not improve . The first r and omised trial of delayed prescriptions for respiratory symptoms was undertaken by Little et al ( 1997 ) , who gave antibiotics , with the prescription to be filled immediately or after three days , or no antibiotics for acute sore throat.3 The immediate group filled 99 % of the antibiotic prescriptions whereas the delayed group filled only 31 % with no apparent serious harms . In the group not given any antibiotics 13 % ended up filling an antibiotic prescription after a return visit to the doctor . Critics of delayed prescriptions say that the strategy increases the use of antibiotics by comparing the 13 % with the 31 % . This is not how we see the use of delayed prescriptions . Their use should be restricted to those patients who request antibiotics or whom their doctor thinks they want an antibiotic yet does not think one is immediately indicated . However , only one of the r and omised trials has examined such a specific group.4 Five controlled trials of delayed prescriptions have been published , conducted in patients with otitis media,5,6 sore throat,3 cough lasting seven days,7 and the common cold.4 In three trials the patients in the delayed prescription arm had more symptoms during the trial , which implies that patients are willing to tolerate some symptoms to avoid antibiotics.3,6,7 Ironically the study with the highest reduction in relative risk ( 75 % ) was the study in children with otitis media , in spite of the children having more symptoms.6 We speculate that parents may be more concerned about avoiding antibiotics in their children than in themselves — a view supported by a qualitative study of patients with sore throat.8 The largest reductions in antibiotic consumption occurred in the three studies which required patients to return to the surgery to collect the prescriptions.3,6,7 Although most of the studies had pick-up suggestions of three days or less , the study on acute cough , which suggested waiting seven days , still produced a reduction in relative risk of 55 % . An additional benefit of delayed prescriptions may be a reduction in repeat visits , at least for sore throat.9 The reduction in usage of antibiotics for infections of the upper respiratory tract through using delayed prescriptions is as effective as , and in many cases more effective than , educational projects.10 - 11 However , no studies have directly compared delayed prescriptions with educational projects . Some interesting insights have been obtained from qualitative work in patients and doctors on delayed prescriptions.12 Not all general practitioners endorsed the use of delayed prescriptions — some had concerns that they may be missing or masking serious illness , with concomitant medicolegal issues . Some worried that their patients may consider them incompetent . General practitioners thought that the positive aspects of delayed prescriptions included avoiding side effects , reducing the drug bill , educating patients , and involving patients in decision making . Although reducing antibiotic resistance was a major issue for general practitioners it was not a concern for patients .12 More education for patients around this issue may be warranted , and we suggest that the delayed prescription be used as a tool to help improve patients ' knowledge about infectious disease and awareness of the need for monitoring their own progress . Research is also needed on other methods of providing a barrier other than a patient 's return to the practice if he or she is not getting better . Such barriers could be asking patients to wait seven days rather than three and post-dating prescriptions . If delayed prescriptions are to become routine then surgeries will need to have systems to hold the prescription at the front desk and to allow patients easy access for re assessment if concerned about their symptoms . They may also need to consider following up patients with delayed prescriptions to monitor adverse events . In the qualitative research on delayed prescriptions several general practitioners no longer used this strategy , once their patients had become “ trained ” not to expect antibiotics . As prescribing becomes more rational the need for delayed prescriptions for respiratory tract infections may in time become redundant Abstract Objective : To assess three prescribing strategies for sore throat . Design : R and omised follow up study . Setting : 11 general practice s in the South and West region . Subjects : 716 patients aged 4 years and over with sore throat and an abnormal physical sign in the throat ; 84 % had tonsillitis or pharyngitis . Patients were r and omised to three groups : prescription for antibiotics for 10 days ( group 1 , 246 patients ) ; no prescription ( group 2 , 230 patients ) ; or prescription for antibiotics if symptoms were not starting to settle after three days ( group 3 ; 238 patients ) . Main outcome measures : Duration of symptoms ; satisfaction and compliance with and perceived efficacy of antibiotics ; time off school or work . Outcomes were documented in 582 subjects ( 81 % ) . Results : Median duration of antibiotic use differed significantly in the three groups ( 10 v 0 v 0 days , P<0.001 ) ; 69 % of patients in group 3 did not use their prescription . The proportion of patients better by day 3 did not differ significantly ( 37 % v 35 % v 30 % , P=0.28 ) , nor did the duration of illness ( median 4 v 5 v 5 days , P=0.39 ) , days off work or school ( median 2 v 2 v 1 , P=0.13 ) , or proportion of patients satisfied ( 96 % v 90 % v 93 % , P=0.09 ) , although group 1 had fewer days of fever ( median 1 v 2 v 2 days , P=0.04 ) . More patients in group 1 thought the antibiotics were effective ( 87 % v 55 % v 60 % , P<0.001 ) and intended coming to the doctor in future attacks ( 79 % v 54 % v 57 % , P<0.001 ) . “ Legitimation ” of illness — to explain to work or school ( 60 % ) or family or friends (37%)–was an important reason for consultation . Patients who were more satisfied got better more quickly , and satisfaction related strongly to how well the doctor dealt with patient 's concerns . Conclusion : Prescribing antibiotics for sore throat only marginally affects the resolution of symptoms but enhances belief in antibiotics and intention to consult in future when compared with the acceptable strategies of no prescription or delayed prescription . Psychosocial factors are important in the decision to see a general practitioner and in predicting the duration of illness . Key messages Sore throat is one of the commonest presentations of upper respiratory illness to general practitioners , and attendance is increasing Prescribing antibiotics for sore throat does not reduce the extent and duration of symptoms Prescribing antibiotics enhances belief in antibiotics and intention to consult Legitimation of illness is an important reason for attending the doctor Satisfaction predicts duration of illness and closely relates to how well concerns are dealt with — unless patients are very ill , general practitioners should consider exploring concerns and should avoid or delay prescribing IMPORTANCE Delayed antibiotic prescription helps to reduce antibiotic use with reasonable symptom control . There are different strategies of delayed prescription , but it is not yet clear which one is the most effective . OBJECTIVE To determine the efficacy and safety of 2 delayed strategies in acute , uncomplicated respiratory infections . DESIGN , SETTING , AND PARTICIPANTS We recruited 405 adults with acute , uncomplicated respiratory infections from 23 primary care centers in Spain to participate in a pragmatic , open-label , r and omized clinical trial . INTERVENTIONS Patients were r and omized to 1 of 4 potential prescription strategies : ( 1 ) a delayed patient-led prescription strategy ; ( 2 ) a delayed prescription collection strategy requiring patients to collect their prescription from the primary care center ; ( 3 ) an immediate prescription strategy ; or ( 4 ) a no antibiotic strategy . Delayed prescription strategies consist of prescribing an antibiotic to take only if the symptoms worsen or if there is no improvement several days after the medical visit . MAIN OUTCOMES AND MEASURES The primary outcomes were the duration of symptoms and severity of symptoms . Each symptom was scored using a 6-point Likert scale ( scores of 3 or 4 were considered moderate ; 5 or 6 , severe ) . Secondary outcomes included antibiotic use , patient satisfaction , and patients ' beliefs in the effectiveness of antibiotics . RESULTS A total of 405 patients were recruited , 398 of whom were included in the analysis ; 136 patients ( 34.2 % ) were men ; mean ( SD ) age , 45 ( 17 ) years . The mean severity of symptoms ranged from 1.8 to 3.5 points on the Likert scale , and mean ( SD ) duration of symptoms described on first visit was 6 ( 6 ) days . The mean ( SD ) general health status on first visit was 54 ( 20 ) based on a scale with 0 indicating worst health status ; 100 , best status . Overall , 314 patients ( 80.1 % ) were nonsmokers , and 372 patients ( 93.5 % ) did not have a respiratory comorbidity . The presence of symptoms on first visit was similar among the 4 groups . The mean ( SD ) duration of severe symptoms was 3.6 ( 3.3 ) days for the immediate prescription group and 4.7 ( 3.6 ) days for the no prescription group . The median ( interquartile range [ IQR ] ) of severe symptoms was 3 ( 1 - 4 ) days for the prescription collection group and 3 ( 2 - 6 ) days for the patient-led prescription group . The median ( IQR ) of the maximum severity for any symptom was 5 ( 3 - 5 ) for the immediate prescription group and the prescription collection group ; 5 ( 4 - 5 ) for the patient-led prescription group ; and 5 ( 4 - 6 ) for the no prescription group . Patients r and omized to the no prescription strategy or to either of the delayed strategies used fewer antibiotics and less frequently believed in antibiotic effectiveness . Satisfaction was similar across groups . CONCLUSIONS AND RELEVANCE Delayed strategies were associated with slightly greater but clinical ly similar symptom burden and duration and also with substantially reduced antibiotic use when compared with an immediate strategy . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01363531 Background In North America , although it varies according to the specific type of acute respiratory infections ( ARI ) , use of antibiotics is estimated to be well above the expected prevalence of bacterial infections . The objective of this pilot clustered r and omized controlled trial ( RCT ) is to assess the feasibility of a larger clustered RCT aim ing at evaluating the impact of DECISION+ , a continuing professional development ( CPD ) program in shared decision making , on the optimal use of antibiotics in the context of ARI . Methods / design This pilot study is a cluster RCT conducted with family physicians from Family Medicine Groups ( FMG ) in the Quebec City area , Canada . Participating FMG are r and omised to an immediate DECISION+ group , a CPD program in shared decision making , ( experimental group ) , or a delayed DECISION+ group ( control group ) . Data collection involves recruiting five patients consulting for ARI per physician from both study groups before ( Phase 1 ) and after ( Phase 2 ) exposure of the experimental group to the DECISION+ program , and after exposure of the control group to the DECISION+ program ( Phase 3 ) . The primary outcome measures to assess the feasibility of a larger RCT include : 1 ) proportion of contacted FMG that agree to participate ; 2 ) proportion of recruited physicians who participate in the DECISION+ program ; 3 ) level of satisfaction of physicians regarding DECISION+ ; and 4 ) proportion of missing data in each data collection phase . Levels of agreement of the patient-physician dyad on the Decisional Conflict Scale and physicians ' prescription profile for ARI are performed as secondary outcome measures . Discussion This study protocol is informative for research ers and clinicians interested in design ing and /or conducting clustered RCT with FMG regarding training of physicians in shared decision making . Trial Registration Clinical Trials.gov Identifier : Objective To assess the impact on adverse outcomes of different antibiotic prescribing strategies for lower respiratory tract infections in people aged 16 years or more . Design Prospect i ve cohort study . Setting UK general practice . Participants 28 883 patients with lower respiratory tract infection ; symptoms , signs , and antibiotic prescribing strategies were recorded at the index consultation . Main outcome measures The main outcomes were reconsultation with symptoms of lower respiratory tract infection in the 30 days after the index consultation , hospital admission , or death . Multivariable analysis controlled for an extensive list of variables related to the propensity to prescribe antibiotics and for clustering by doctor . Results Of the 28 883 participants , 104 ( 0.4 % ) were referred to hospital for radiographic investigation or admission , or both on the day of the index consultation , or were admitted with cancer . Of the remaining 28 779 , subsequent hospital admission or death occurred in 26/7332 ( 0.3 % ) after no antibiotic prescription , 156/17 628 ( 0.9 % ) after pres
Output:
| One study favoured delayed antibiotics over no antibiotics for pain , fever , and cough duration ( moderate quality evidence for all clinical outcomes - GRADE assessment ) .There were either no differences for adverse effects or results favoured delayed antibiotics over immediate antibiotics ( low quality evidence - to GRADE assessment ) with no significant differences in complication rates .
For many clinical outcomes , there were no differences between prescribing strategies .
Symptoms for acute otitis media and sore throat were modestly improved by immediate antibiotics compared with delayed antibiotics .
There were no differences in complication rates .
Delayed antibiotics for people with acute respiratory infection reduced antibiotic use compared to immediate antibiotics , but was not shown to be different to no antibiotics in terms of symptom control and disease complications .
Where clinicians feel it is safe not to prescribe antibiotics immediately for people with respiratory infections , no antibiotics with advice to return if symptoms do not resolve is likely to result in the least antibiotic use while maintaining similar patient satisfaction and clinical outcomes to delaying prescription of antibiotics .
Where clinicians are not confident in using a no antibiotic strategy , a delayed antibiotics strategy may be an acceptable compromise in place of immediate prescribing to significantly reduce unnecessary antibiotic use for RTIs , and thereby reduce antibiotic resistance , while maintaining patient safety and satisfaction levels . |
MS211658 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: IMPORTANCE Severely injured patients experiencing hemorrhagic shock often require massive transfusion . Earlier transfusion with higher blood product ratios ( plasma , platelets , and red blood cells ) , defined as damage control resuscitation , has been associated with improved outcomes ; however , there have been no large multicenter clinical trials . OBJECTIVE To determine the effectiveness and safety of transfusing patients with severe trauma and major bleeding using plasma , platelets , and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio . DESIGN , SETTING , AND PARTICIPANTS Pragmatic , phase 3 , multisite , r and omized clinical trial of 680 severely injured patients who arrived at 1 of 12 level I trauma centers in North America directly from the scene and were predicted to require massive transfusion between August 2012 and December 2013 . INTERVENTIONS Blood product ratios of 1:1:1 ( 338 patients ) vs 1:1:2 ( 342 patients ) during active resuscitation in addition to all local st and ard-of-care interventions ( uncontrolled ) . MAIN OUTCOMES AND MEASURES Primary outcomes were 24-hour and 30-day all-cause mortality . Prespecified ancillary outcomes included time to hemostasis , blood product volumes transfused , complications , incidence of surgical procedures , and functional status . RESULTS No significant differences were detected in mortality at 24 hours ( 12.7 % in 1:1:1 group vs 17.0 % in 1:1:2 group ; difference , -4.2 % [ 95 % CI , -9.6 % to 1.1 % ] ; P = .12 ) or at 30 days ( 22.4 % vs 26.1 % , respectively ; difference , -3.7 % [ 95 % CI , -10.2 % to 2.7 % ] ; P = .26 ) . Exsanguination , which was the predominant cause of death within the first 24 hours , was significantly decreased in the 1:1:1 group ( 9.2 % vs 14.6 % in 1:1:2 group ; difference , -5.4 % [ 95 % CI , -10.4 % to -0.5 % ] ; P = .03 ) . More patients in the 1:1:1 group achieved hemostasis than in the 1:1:2 group ( 86 % vs 78 % , respectively ; P = .006 ) . Despite the 1:1:1 group receiving more plasma ( median of 7 U vs 5 U , P < .001 ) and platelets ( 12 U vs 6 U , P < .001 ) and similar amounts of red blood cells ( 9 U ) over the first 24 hours , no differences between the 2 groups were found for the 23 prespecified complications , including acute respiratory distress syndrome , multiple organ failure , venous thromboembolism , sepsis , and transfusion-related complications . CONCLUSIONS AND RELEVANCE Among patients with severe trauma and major bleeding , early administration of plasma , platelets , and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio did not result in significant differences in mortality at 24 hours or at 30 days . However , more patients in the 1:1:1 group achieved hemostasis and fewer experienced death due to exsanguination by 24 hours . Even though there was an increased use of plasma and platelets transfused in the 1:1:1 group , no other safety differences were identified between the 2 groups . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01545232 Introduction The California Prehospital Antifibrinolytic Therapy ( Cal-PAT ) study seeks to assess the safety and impact on patient mortality of tranexamic acid ( TXA ) administration in cases of trauma-induced hemorrhagic shock . The current study further aim ed to assess the feasibility of prehospital TXA administration by paramedics within the framework of North American emergency medicine st and ards and protocol s. Methods This is an ongoing multi-centered , prospect i ve , observational cohort study with a retrospective chart- review comparison . Trauma patients identified in the prehospital setting with signs of hemorrhagic shock by first responders were administered one gram of TXA followed by an optional second one-gram dose upon arrival to the hospital , if the patient still met inclusion criteria . Patients administered TXA make up the prehospital intervention group . Control group patients met the same inclusion criteria as TXA c and i date s and were matched with the prehospital intervention patients based on mechanism of injury , injury severity score , and age . The primary outcomes were mortality , measured at 24 hours , 48 hours , and 28 days . Secondary outcomes measured included the total blood products transfused and any known adverse events associated with TXA administration . Results We included 128 patients in the prehospital intervention group and 125 in the control group . Although not statistically significant , the prehospital intervention group trended toward a lower 24-hour mortality rate ( 3.9 % vs 7.2 % for intervention and control , respectively , p=0.25 ) , 48-hour mortality rate ( 6.3 % vs 7.2 % for intervention and control , respectively , p=0.76 ) , and 28-day mortality rate ( 6.3 % vs 10.4 % for intervention and control , respectively , p=0.23 ) . There was no significant difference observed in known adverse events associated with TXA administration in the prehospital intervention group and control group . A reduction in total blood product usage was observed following the administration of TXA ( control : 6.95 units ; intervention : 4.09 units ; p=0.01 ) . Conclusion Preliminary evidence from the Cal-PAT study suggests that TXA administration may be safe in the prehospital setting with no significant change in adverse events observed and an associated decreased use of blood products in cases of trauma-induced hemorrhagic shock . Given the current sample size , a statistically significant decrease in mortality was not observed . Additionally , this study demonstrates that it may be feasible for paramedics to identify and safely administer TXA in the prehospital setting OBJECTIVE To quantify the impact of fibrinogen-containing cryoprecipitate in addition to the antifibrinolytic tranexamic acid on survival in combat injured . DESIGN Retrospective observational study comparing the mortality of 4 groups : tranexamic acid only , cryoprecipitate only , tranexamic acid and cryoprecipitate , and neither tranexamic acid nor cryoprecipitate . To balance comparisons , propensity scores were developed and added as covariates to logistic regression models predicting mortality . SETTING A Role 3 Combat Surgical Hospital in southern Afghanistan . PATIENTS A total of 1332 patients were identified from prospect ively collected U.K. and U.S. trauma registries who required 1 U or more of packed red blood cells and composed the following groups : tranexamic acid ( n = 148 ) , cryoprecipitate ( n = 168 ) , tranexamic acid/cryoprecipitate ( n = 258 ) , and no tranexamic acid/cryoprecipitate ( n = 758 ) . MAIN OUTCOME MEASURE In-hospital mortality . RESULTS Injury severity scores were highest in the cryoprecipitate ( mean [ SD ] , 28.3 [ 15.7 ] ) and tranexamic acid/cryoprecipitate ( mean [ SD ] , 26 [ 14.9 ] ) groups compared with the tranexamic acid ( mean [ SD ] , 23.0 [ 19.2 ] ) and no tranexamic acid/cryoprecipitate ( mean [ SD ] , 21.2 [ 18.5 ] ) ( P < .001 ) groups . Despite greater Injury Severity Scores and packed red blood cell requirements , mortality was lowest in the tranexamic acid/cryoprecipitate ( 11.6 % ) and tranexamic acid ( 18.2 % ) groups compared with the cryoprecipitate ( 21.4 % ) and no tranexamic acid/cryoprecipitate ( 23.6 % ) groups . Tranexamic acid and cryoprecipitate were independently associated with a similarly reduced mortality ( odds ratio , 0.61 ; 95 % CI , 0.42 - 0.89 ; P = .01 and odds ratio , 0.61 ; 95 % CI , 0.40 - 0.94 ; P = .02 , respectively ) . The combined tranexamic acid and cryoprecipitate effect vs. neither in a synergy model had an odds ratio of 0.34 ( 95 % CI , 0.20 - 0.58 ; P < .001 ) , reflecting nonsignificant interaction ( P = .21 ) . CONCLUSIONS Cryoprecipitate may independently add to the survival benefit of tranexamic acid in the seriously injured requiring transfusion . Additional study is necessary to define the role of fibrinogen in resuscitation from hemorrhagic shock Background Traumatic brain injury ( TBI ) is commonly accompanied by intracranial bleeding which can worsen after hospital admission . Tranexamic acid ( TXA ) has been shown to reduce bleeding in elective surgery and there is evidence that short courses of TXA can reduce rebleeding in spontaneous intracranial haemorrhage . We aim ed to determine the effectiveness and safety of TXA in preventing progressive intracranial haemorrhage in TBI . Methods This is a double blinded , placebo controlled r and omized trial . We enrolled 238 patients older than 16 years with moderate to severe TBI ( post-resuscitation Glasgow Coma Scale ( GCS ) 4 to 12 ) who had a computerized tomography ( CT ) brain scan within eight hours of injury and in whom there was no immediate indication for surgery . We excluded patients if they had a coagulopathy or a serum creatinine over than 2.0 milligrams% . The treatment was a single dose of 2 grams of TXA in addition to other st and ard treatments . The primary outcome was progressive intracranial haemorrhage ( PIH ) which was defined as an intracranial haemorrhage seen on the second CT scan that was not seen on the first CT scan , or an intracranial haemorrhage seen on the first scan that had exp and ed by 25 % or more on any dimension ( height , length , or width ) on the second scan . Results Progressive intracranial haemorrhage was present in 21 ( 18 % ) of 120 patients allocated to TXA and in 32 ( 27 % ) of 118 patients allocated to placebo . The difference was not statistically significant [ RR = 0.65 ( 95 % CI 0.40 to 1.05 ) ] . There were no significant difference in the risk of death from all causes in patients allocated to TXA compared with placebo [ RR = 0.69 ( 95 % CI 0.35 to 1.39 ) ] and the risk of unfavourable outcome on the Glasgow Outcome Scale [ RR = 0.76 ( 95 % CI 0.46 to 1.27 ) ] . There was no evidence of increased risk of thromboembolic events in those patients allocated to TXA . Conclusions TXA may reduce PIH in patients with TBI ; however , the difference was not statistically significant in this trial . Large clinical trials are needed to confirm and to assess the effect of TXA on death or disability after TBI BACKGROUND Tranexamic acid can reduce bleeding in patients undergoing elective surgery . We assessed the effects of early administration of a short course of tranexamic acid on death , vascular occlusive events , and the receipt of blood transfusion in trauma patients . METHODS This r and omised controlled trial was undertaken in 274 hospitals in 40 countries . 20 211 adult trauma patients with , or at risk of significant bleeding were r and omly assigned within 8 h of injury to either tranexamic acid ( loading dose 1 g over 10 min then infusion of 1 g over 8 h ) or matching placebo . R and omisation was balanced by centre , with an allocation sequence based on a block size of eight , generated with a computer r and om number generator Both participants and study staff ( site investigators and trial coordinating centre staff ) were masked to treatment allocation . The primary outcome was death in hospital within 4 weeks of injury , and was described with the following categories : bleeding , vascular occlusion ( myocardial infa rct ion , stroke and pulmonary embolism ) , multiorgan failure , head injury , and other AL analyses were by intention to treat . This study is registered as IS RCT N86750102 , Clinical trials.gov NCT00375258 , and South African Clinical Trial Register DOH-27 - 0607 - 1919 . RESULTS 10096 patients were allocated to tranexamic acid and 10 115 to placebo , of whom 10060 and 10067 , respectively , were analysed . All-cause mortality was significantly reduced with tranexamic acid ( 1463 [ 14.5 % ] tranexamic acid group vs 1613 [ 160 % ] placebo group ; relative risk 0.91 , 95 % CI 085 - 097 ; p = 00035 ) . The risk of death due to bleeding was significantly reduced ( 489 [ 49 % ] vs 574 [ 5 - 7 % ] ; relative risk 0 - 85 , 95 % CI 0.76 - 0.96 ;
Output:
| Conclusion Compared to the CRASH-2 trial , adult trauma patients receiving TXA identified in our systematic review had a lower incidence of mortality at 28 or 30 days , but a higher incidence of in-hospital thrombotic events .
Our findings neither support nor refute the findings of the CRASH-2 trial but suggest that incidence rates in adults with trauma in setting s outside of the CRASH-2 trial may be different than those observed in the CRASH-2 trial |
MS211659 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Seasonal affective disorder ( SAD ) is a syndrome characterized by recurrent depressions that occur annually at the same time each year . We describe 29 patients with SAD ; most of them had a bipolar affective disorder , especially bipolar II , and their depressions were generally characterized by hypersomnia , overeating , and carbohydrate craving and seemed to respond to changes in climate and latitude . Sleep recordings in nine depressed patients confirmed the presence of hypersomnia and showed increased sleep latency and reduced slow-wave ( delta ) sleep . Preliminary studies in 11 patients suggest that extending the photoperiod with bright artificial light has an antidepressant effect IMPORTANCE Bright light therapy is an evidence -based treatment for seasonal depression , but there is limited evidence for its efficacy in nonseasonal major depressive disorder ( MDD ) . OBJECTIVE To determine the efficacy of light treatment , in monotherapy and in combination with fluoxetine hydrochloride , compared with a sham-placebo condition in adults with nonseasonal MDD . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo- and sham-controlled , 8-week trial in adults ( aged 19 - 60 years ) with MDD of at least moderate severity in outpatient psychiatry clinics in academic medical centers . Data were collected from October 7 , 2009 , to March 11 , 2014 . Analysis was based on modified intent to treat ( r and omized patients with ≥1 follow-up rating ) . INTERVENTIONS Patients were r and omly assigned to ( 1 ) light monotherapy ( active 10,000-lux fluorescent white light box for 30 min/d in the early morning plus placebo pill ) ; ( 2 ) antidepressant monotherapy ( inactive negative ion generator for 30 min/d plus fluoxetine hydrochloride , 20 mg/d ) ; ( 3 ) combination light and antidepressant ; or ( 4 ) placebo ( inactive negative ion generator plus placebo pill ) . MAIN OUTCOMES AND MEASURES Change score on the Montgomery-Åsberg Depression Rating Scale ( MADRS ) from baseline to the 8-week end point . Secondary outcomes included response ( ≥50 % reduction in MADRS score ) and remission ( MADRS score ≤10 at end point ) . RESULTS A total of 122 patients were r and omized ( light monotherapy , 32 ; fluoxetine monotherapy , 31 ; combination therapy , 29 ; placebo , 30 ) . The mean ( SD ) changes in MADRS score for the light , fluoxetine , combination , and placebo groups were 13.4 ( 7.5 ) , 8.8 ( 9.9 ) , 16.9 ( 9.2 ) , and 6.5 ( 9.6 ) , respectively . The combination ( effect size [ d ] = 1.11 ; 95 % CI , 0.54 to 1.64 ) and light monotherapy ( d = 0.80 ; 95 % CI , 0.28 to 1.31 ) were significantly superior to placebo in the MADRS change score , but fluoxetine monotherapy ( d = 0.24 ; 95 % CI , -0.27 to 0.74 ) was not superior to placebo . For the respective placebo , fluoxetine , light , and combination groups at the end point , response was achieved by 10 ( 33.3 % ) , 9 ( 29.0 % ) , 16 ( 50.0 % ) , and 22 ( 75.9 % ) and remission was achieved by 9 ( 30.0 % ) , 6 ( 19.4 % ) , 14 ( 43.8 % ) , and 17 ( 58.6 % ) . Combination therapy was superior to placebo in MADRS response ( β = 1.70 ; df = 1 ; P = .005 ) and remission ( β = 1.33 ; df = 1 ; P = .02 ) , with numbers needed to treat of 2.4 ( 95 % CI , 1.6 to 5.8 ) and 3.5 ( 95 % CI , 2.0 to 29.9 ) , respectively . All treatments were generally well tolerated , with few significant differences in treatment-emergent adverse events . CONCLUSIONS AND RELEVANCE Bright light treatment , both as monotherapy and in combination with fluoxetine , was efficacious and well tolerated in the treatment of adults with nonseasonal MDD . The combination treatment had the most consistent effects . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00958204 Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more BACKGROUND Bright light therapy was shown to be a promising treatment for depression during pregnancy in a recent open-label study . In an extension of this work , we report findings from a double-blind placebo-controlled pilot study . METHOD Ten pregnant women with DSM-IV major depressive disorder were r and omly assigned from April 2000 to January 2002 to a 5-week clinical trial with either a 7000 lux ( active ) or 500 lux ( placebo ) light box . At the end of the r and omized controlled trial , subjects had the option of continuing in a 5-week extension phase . The Structured Interview Guide for the Hamilton Depression Scale-Seasonal Affective Disorder Version was administered to assess changes in clinical status . Salivary melatonin was used to index circadian rhythm phase for comparison with antidepressant results . RESULTS Although there was a small mean group advantage of active treatment throughout the r and omized controlled trial , it was not statistically significant . However , in the longer 10-week trial , the presence of active versus placebo light produced a clear treatment effect ( p = .001 ) with an effect size ( 0.43 ) similar to that seen in antidepressant drug trials . Successful treatment with bright light was associated with phase advances of the melatonin rhythm . CONCLUSION These findings provide additional evidence for an active effect of bright light therapy for antepartum depression and underscore the need for an exp and ed r and omized clinical trial OBJECTIVE Phototherapy , ie , bright light therapy , is an effective and safe treatment of major depressive disorder ( MDD ) . It exerts rapid mood-elevating activity , similar to antidepressant medications , most likely mediated through both monoaminergic and circadian system melatonergic mechanisms . We assessed the efficiency of bright light therapy as an adjuvant treatment to antidepressant pharmacotherapy in patients with severe MDD r and omized by Hamilton Depression Rating Scale ( HDRS ) score to either ( 1 ) 150 mg venlafaxine hydrochloride daily at 7:00 AM or ( 2 ) 150 mg venlafaxine plus 60-minute light of 7000 lux the initial week of clinical management ( venlafaxine + bright light therapy ) daily at 7:00 AM . METHOD 50 in patients with severe MDD at the Psychiatry Clinic of Yüzüncü Yıl University Training and Education Hospital participated . The study , which was conducted from January 2013 through June 2014 , entailed patients diagnosed with severe MDD based on DSM-IV-TR for the first time . Mood states were assessed by the HDRS , Profile of Mood States ( POMS ) , and Beck Depression Inventory ( BDI ) before treatment and at 1 , 2 , 4 , and 8 weeks of treatment . RESULTS On the basis of the HDRS score as the primary outcome variable , both strategies significantly improved depression and negative mood states already at the first treatment week ( P < .001 ) . Differences in therapeutic effects by treatment strategy were remarkable at the second and fourth weeks of clinical management ( P = .018 and P = .011 , respectively ) , with beneficial effects continuing until trial conclusion . Those treated with venlafaxine + bright light therapy evidence d significantly lower HDRS depression scores ( P < .05 ) as well as BDI scores ( P < .05 ) and POMS negative mood states scores ( depression-dejection , tension-anxiety , anger-hostility , fatigue-inertia , and confusion-bewilderment subscales ; all P < .05 ) after the second week . At week 4 of the trial , 19 ( 76 % ) of the 25 venlafaxine + bright light therapy patients versus just 11 ( 44 % ) of the 25 venlafaxine patients ( P < .05 ) attained the target goal of treatment , a HDRS score ≤ 13 , indicative of mild depression , and , although not statistically significant in our small sample study ( P = .36 ) , at week 8 , 76 % of venlafaxine + bright light therapy patients ( n = 19 ) versus just 64 % of the venlafaxine patients ( n = 16 ) experienced complete remission of depression ( HDRS score ≤ 7 ) . CONCLUSIONS Both venlafaxine and venlafaxine + bright light therapy treatment strategies significantly reversed the depressive mood of patients with severe MDD ; however , the latter induced significantly stronger and more rapid beneficial effects . Future longer-term studies with large sample sizes , nonetheless , are required to confirm and generalize these results to patients of diverse ethnicities and cultures with both severe and mild MDD . TRIAL REGISTRATION ANZCTR.org.au registration number : ACTRN12614001061628 CONTEXT Major depressive disorder ( MDD ) in elderly individuals is prevalent and debilitating . It is accompanied by circadian rhythm disturbances associated with impaired functioning of the suprachiasmatic nucleus , the biological clock of the brain . Circadian rhythm disturbances are common in the elderly . Suprachiasmatic nucleus stimulation using bright light treatment ( BLT ) may , therefore , improve mood , sleep , and hormonal rhythms in elderly patients with MDD . OBJECTIVE To determine the efficacy of BLT in elderly patients with MDD . DESIGN Double-blind , placebo-controlled r and omized clinical trial . SETTING Home-based treatment in patients recruited from outpatient clinics and from case-finding using general practitioners ' offices in the Amsterdam region . PARTICIPANTS Eighty-nine out patients 60 years or older who had MDD underwent assessment at baseline ( T0 ) , after 3 weeks of treatment ( T1 ) , and 3 weeks after the end of treatment ( T2 ) . Intervention Three weeks of 1-hour early-morning BLT ( pale blue , approximately 7500 lux ) vs placebo ( dim red light , approximately 50 lux ) . MAIN OUTCOME MEASURES Mean improvement in Hamilton Scale for Depression scores at T1 and T2 using parameters of sleep and cortisol and melatonin levels . RESULTS Intention-to-treat analysis showed Hamilton Scale for Depression scores to improve with BLT more than placebo from T0 to T1 ( 7 % ; 95 % confidence interval , 4%-23 % ; P = .03 ) and from T0 to T2 ( 21 % ; 7%-31 % ; P = .001 ) . At T1 relative to T0 , get-up time after final awakening in the BLT group advanced by 7 % ( P < .001 ) , sleep efficiency increased by 2 % ( P = .01 ) , and the steepness of the rise in evening melatonin levels increased by 81 % ( P = .03 ) compared with the placebo group . At T2 relative to T0 , get-up time was still advanced by 3 % ( P = .001 ) and the 24-hour urinary free cortisol level was 37 % lower ( P = .003 ) compared with the placebo group . The evening salivary cortisol level had decreased by 34 % in the BLT group compared with an increase of 7 % in the placebo group ( P = .02 ) . CONCLUSIONS In elderly patients with MDD , BLT improved mood , enhanced sleep efficiency , and increased the upslope melatonin level gradient . In addition , BLT produced continuing improvement in mood and an attenuation of cortisol hyperexcretion after discontinuation of treatment . TRIAL REGISTRATION clinical trials.gov Identifier NCT00332670 OBJECTIVE Light therapy and antidepressants have shown comparable efficacy in separate studies of seasonal affective disorder treatment , but few studies have directly compared the two treatments . This study compared the effectiveness of light therapy and an antidepressant within a single trial . METHOD This double-blind , r and omized , controlled trial was conducted in four Canadian centers over three winter seasons . Patients met DSM-IV criteria for major depressive disorder with a seasonal ( winter ) pattern and had scores > or = 23 on the 24-item Hamilton Depression Rating Scale . After a baseline observation week , eligible patients were r and omly assigned to 8 weeks of double-blind treatment with either 1 ) 10,000-lux light treatment and a placebo capsule , or 2 ) 100-lux light treatment ( placebo light ) and fluoxetine , 20 mg/day . Light treatment was applied for 30 minutes/day in the morning with a fluorescent white-light box ; placebo light boxes used neutral density filters . RESULTS A total of 96 patients were r and omly assigned to a treatment condition . Intent-to-treat analysis showed overall improvement with time , with no differences between treatments . There
Output:
| However , considering that light therapy has minimal side-effects and our meta- analysis demonstrated that a significant proportion of patients achieved a clinical ly significant response , light therapy may be effective for patients with non-seasonal depression and can be a helpful additional therapeutic intervention for depression . |
MS211660 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND We report data from NEWART , a r and omised phase 4 clinical trial comparing virologic efficacy and safety of nevirapine ( NVP ) vs. ritonavir-boosted atazanavir ( ATV/r ) on a background of tenofovir/emtricitabine ( TDF/FTC ) in HIV-1-infected treatment-naïve patients . This study enrolled patients according to CD4-based initiation criteria for NVP ( < 250 cells/mm(3 ) for women and < 400 cells/mm(3 ) for men ) , to reduce the likelihood of symptomatic hepatic events . NEWART was design ed to support and confirm results from ARTEN , an international trial with similar design and study endpoints . METHODS A total of 152 patients were r and omised 1 : 1 to open-label NVP 200 mg twice daily or ATV/r ( 300/100 mg ) once daily , plus once daily TDF/FTC ( 300/200 mg ) . All participants met CD4(+ ) guidelines at entry . The primary endpoint for non-inferiority was virologic response prior to and at week 48 ( confirmed HIV plasma viral load < 50 copies/ml , without rebound or change in ARVs ) . Safety data , including plasma lipids , were recorded throughout the study . RESULTS The primary endpoint was achieved in 46/75 ( 61.3 % ) and 50/77 ( 64.9 % ) of patients taking NVP and ATV/r , respectively . Frequency of adverse events ( AEs ) was similar between arms , with 88.0 % of NVP-treated patients and 94.8 % of ATV/r-treated patients experiencing at least one AE . Nine patients ( 12 % ) in each arm experienced an AE that led to discontinuation . At week 48 , a significantly greater increase was seen in mean plasma HDL cholesterol ( HDL-C ) in the NVP arm ( 9.6 mg/dl ) vs. the ATV/r arm ( 3.5 mg/dl ) ; p = 0.016 . Also , total cholesterol (TC):HDL-C ratio on-treatment was -0.38 and -0.02 for the NVP and ATV/r arms , respectively ( p = 0.038 ) . CONCLUSIONS Efficacy results were consistent with the ARTEN study demonstrating that NVP was non-inferior to ATV/r when taken in combination with TDF/FTC . Rates of AEs were similar between the two arms , whereas HDL-C increased and TC : HDL-C decreased significantly more in patients taking NVP than ATV/r Objective : To assess the safety and efficacy of two , single-tablet regimens for the initial treatment of HIV infection . Design : Phase 2 , r and omized , double-blind , double-dummy , multicenter , active-controlled study . Methods : Antiretroviral treatment-naive adults with a screening HIV-1 RNA at least 5000 copies/ml and a CD4 cell count more than 50 cells/μl were r and omized 2 : 1 to receive fixed-dose combination tablets of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate ( EVG/COBI/FTC/TDF ; N = 48 ) or efavirenz/emtricitabine/tenofovir disoproxil fumarate ( EFV/FTC/TDF ; n = 23 ) for 48 weeks . The primary endpoint was proportion of participants with HIV-1 RNA less than 50 copies/ml at week 24 . Results : Participants receiving EVG/COBI/FTC/TDF exhibited a more rapid decline in HIV-1 RNA and a greater proportion suppressed viral load to less than 50 copies/ml than participants receiving EFV/FTC/TDF . Both EVG/COBI/FTC/TDF and EFV/FTC/TDF result ed in high rates of viral suppression and increases in CD4 cell count . Ninety and 83 % of participants suppressed HIV-1 RNA to less than 50 copies/ml both at the 24-week and 48-week visits for EVG/COBI/FTC/TDF and EFV/FTC/TDF , respectively . Once-daily administration of EVG/COBI/FTC/TDF provided a mean EVG trough concentration 10-fold over its protein binding-adjusted IC95 across study visits . EVG/FTC/TDF/GS-9350 was generally well tolerated with a lower rate of drug-related central nervous system ( 17 % ) and psychiatric ( 10 % ) adverse events versus EFV/FTC/TDF ( 26 and 44 % , respectively ) . Decreases in estimated glomerular filtration rate occurred within the first few weeks of dosing in participants receiving EVG/COBI/FTC/TDF , remained within the normal range and did not progress at week 24 or 48 ; no participant experienced a clinical adverse event or discontinued study drug due to changes in serum creatinine or renal function . Conclusion : Once-daily EVG/COBI/FTC/TDF achieved and maintained a high rate of virologic suppression with fewer central nervous system and psychiatric adverse events compared to a current st and ard-of-care regimen of EFV/FTC/TDF ABSTRACT Background Patients infected with HIV-1 initiating antiretroviral therapy ( ART ) containing a non-nucleoside reverse transcriptase inhibitor ( NNRTI ) show presumably fewer atherogenic lipid changes than those initiating most ARTs containing a protease inhibitor . We analysed whether lipid changes differed between the two most commonly used NNRTIs , nevirapine ( NVP ) and efavirenz ( EFV ) . Methods and Findings Prospect i ve analysis of lipids and lipoproteins was performed in patients enrolled in the NVP and EFV treatment groups of the 2NN study who remained on allocated treatment during 48 wk of follow-up . Patients were allocated to NVP ( n = 417 ) , or EFV ( n = 289 ) in combination with stavudine and lamivudine . The primary endpoint was percentage change over 48 wk in high-density lipoprotein cholesterol ( HDL-c ) , total cholesterol ( TC ) , TC : HDL-c ratio , non-HDL-c , low-density lipoprotein cholesterol , and triglycerides . The increase of HDL-c was significantly larger for patients receiving NVP ( 42.5 % ) than for patients receiving EFV ( 33.7 % ; p = 0.036 ) , while the increase in TC was lower ( 26.9 % and 31.1 % , respectively ; p = 0.073 ) , result ing in a decrease of the TC : HDL-c ratio for patients receiving NVP ( −4.1 % ) and an increase for patients receiving EFV ( + 5.9 % ; p < 0.001 ) . The increase of non-HDL-c was smaller for patients receiving NVP ( 24.7 % ) than for patients receiving EFV ( 33.6 % ; p = 0.007 ) , as were the increases of triglycerides ( 20.1 % and 49.0 % , respectively ; p < 0.001 ) and low-density lipoprotein cholesterol ( 35.0 % and 40.0 % , respectively ; p = 0.378 ) . These differences remained , or even increased , after adjusting for changes in HIV-1 RNA and CD4 + cell levels , indicating an effect of the drugs on lipids over and above that which may be explained by suppression of HIV-1 infection . The increases in HDL-c were of the same order of magnitude as those seen with the use of the investigational HDL-c-increasing drugs . Conclusion NVP-containing ART shows larger increases in HDL-c and decreases in TC : HDL-c ratio than an EFV-containing regimen . Based on these findings , protease-inhibitor-sparing regimens based on non-nucleoside reverse transcriptase inhibitor , particularly those containing NVP , may be expected to result in a reduced risk of coronary heart disease Introduction : Direct comparison of the efficacy and safety of different agents is needed to guide selection of optimal treatment regimens for therapy-naive HIV-1-infected patients . Methods : Gemini was a 48-week , multicenter , open-label , noninferiority trial in treatment-naive HIV-1-infected adults r and omized to either saquinavir/ritonavir ( SQV/r ) 1000 mg/100 mg twice a day or lopinavir/ritonavir ( LPV/r ) 400 mg/100 mg twice a day , each with emtricitabine/tenofovir 200 mg/300 mg every day . Results : A similar proportion of participants in the SQV/r ( n = 167 ) and LPV/r ( n = 170 ) arms had HIV-1 RNA levels < 50 copies per milliliter at week 48 : 64.7 % vs 63.5 % and estimated difference in proportion for noninferiority : 1.14 % , 96 % confidence interval : −9.6 to11.9 ( P < 0.012 ) , confirming that SQV/r was noninferior to LPV/r treatment . There were no significant differences in week 48 CD4 counts between arms . The rate and severity of adverse events were similar in both groups . There were no significant differences in the median change from baseline between arms in plasma lipids except for triglyceride levels , which were significantly higher in the LPV/r at week 48 . Conclusions : In treatment-naive , HIV-1-infected patients , SQV/r treatment was noninferior in virologic suppression at 48 weeks to LPV/r treatment and offered a better triglyceride profile Background Rates of cardiovascular disease are higher among HIV-infected patients as a result of the complex interplay between traditional risk factors , HIV-related inflammatory and immunologic changes , and effects of antiretroviral therapy ( ART ) . This study prospect ively evaluated changes in cardiovascular biomarkers in an underrepresented , racially diverse , HIV-1-infected population receiving abacavir/lamivudine as backbone therapy . Methods This 96-week , open-label , r and omized , multicenter study compared once-daily fosamprenavir/ritonavir 1400/100 mg and efavirenz 600 mg , both with ABC/3TC 600 mg/300 mg , in antiretroviral-naïve , HLA-B*5701-negative adults without major resistance mutations to study drugs . We evaluated changes from baseline to weeks 4 , 12 , 24 , 48 , and 96 in interleukin-6 ( IL-6 ) , high-sensitivity C-reactive protein ( hs-CRP ) , soluble vascular adhesion molecule-1 ( sVCAM-1 ) , d-dimer , plasminogen , and fibrinogen . Biomarker data were log-transformed before analysis , and changes from baseline were described using geometric mean ratios . Results This study enrolled 101 patients ( 51 receiving fosamprenavir/ritonavir ; 50 receiving efavirenz ) : 32 % female , 60 % African American , and 38 % Hispanic/Latino ; 66 % ( 67/101 ) completed 96 weeks on study . At week 96 , levels of IL-6 , sVCAM-1 , d-dimer , fibrinogen , and plasminogen were lower than baseline in both treatment groups , and the decrease was statistically significant for sVCAM-1 ( fosamprenavir/ritonavir and efavirenz ) , d-dimer ( fosamprenavir/ritonavir and efavirenz ) , fibrinogen ( efavirenz ) , and plasminogen ( efavirenz ) . Values of hs-CRP varied over time in both groups , with a significant increase over baseline at Weeks 4 and 24 in the efavirenz group . At week 96 , there was no difference between the groups in the percentage of patients with HIV-1 RNA < 50 copies/mL ( fosamprenavir/ritonavir 63 % ; efavirenz 66 % ) by ITT missing-equals-failure analysis . Treatment-related grade 2–4 adverse events were more common with efavirenz ( 32 % ) compared with fosamprenavir/ritonavir ( 20 % ) , and median lipid concentrations increased in both groups over 96 weeks of treatment . Conclusions In this study of underrepresented patients , treatment with abacavir/lamivudine combined with either fosamprenavir/ritonavir or efavirenz over 96 weeks , produced stable or declining biomarker levels except for hs-CRP , including significant and favorable decreases in thrombotic activity ( reflected by d-dimer ) and endothelial activation ( reflected by sVCAM-1 ) . Our study adds to the emerging data that some cardiovascular biomarkers are decreased with initiation of ART and control of HIV viremia . Trial registration Clinical Trials.gov identifier CONTEXT Abacavir , a nucleoside analogue , has demonstrated suppression of human immunodeficiency virus ( HIV ) replication alone
Output:
| For viral suppression at 48 weeks , compared with efavirenz , the odds ratio ( OR ) for viral suppression was 1·87 ( 95 % credible interval [ CrI ] 1·34 - 2·64 ) with dolutegravir and 1·40 ( 1·02 - 1·96 ) with raltegravir ; with respect to viral suppression , low-dose efavirenz was similar to all other treatments .
Both low-dose efavirenz and integrase str and transfer inhibitors tended to be protective of discontinuations due to adverse events relative to normal-dose efavirenz . |
MS211661 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Prevalence of type 2 diabetes ( T2D ) is increasing worldwide . T2D prevention by lifestyle intervention is effective . Pragmatic scalable interventions are needed , with evidence to efficiently target and monitor such interventions . We report pooled analyses of data from three European trial cohorts : to analyse T2D incidence , sustained weight loss and utility of risk predictors . Methods We analysed data on 749 adults with impaired glucose tolerance ( 278 men and 471 women , mean age 56 years , mean BMI 31 kgm−2 ) recruited between 1993 and 2003 , and r and omised to intensive lifestyle intervention ( I ) or lifestyle advice control ( C ) . The intervention aim ed to increase physical activity , modify diet , and promote weight loss≥5 % . Using Cox-regression survival analysis , we assessed T2D incidence and the impact on T2D incidence of sustained weight loss , and of baseline cut-point values of FINDRISC score , fasting plasma glucose ( FPG ) , and HbA1c . Results Mean follow-up duration was 3.1 years . T2D was diagnosed in 139 participants ( I = 45/379 , C = 94/370 ) . Cumulative T2D incidence was 57 % lower in the intervention compared with the control group ( HR 0.42 ( 95 % CI 0.29 to 0.60 ) P<0.001 ) . Participants with ≥5 % weight loss at one year had 65 % lower T2D incidence ( HR 0.35 ( 95 % CI 0.22 to 0.56 ) P<0.001 ) ; maintaining ≥5 % weight loss for two and three years further reduced T2D incidence . Recommended cut-points to identify those at high risk for T2D would have identified different proportions of European Diabetes Prevention Study ( EDIPS ) participants with similar hazard-ratios for intervention effect . Conclusions Pooled analysis of EDIPS trial data reinforces evidence for T2D prevention by lifestyle intervention . Analysis showed the preventive effect of ≥5 % weight loss , especially if maintained long term , which has utility for intervention monitoring . Analysis of proposed cut-points demonstrates difficulties in balancing risk and benefit , to efficiently target interventions and suggests evidence is needed to define clinical policy . Trial registration s The Finnish Diabetes Prevention study , Helsinki , Finl and : Clinical Trials.gov ; NCT00518167 The SLIM diabetes prevention study , Maastricht , The Netherl and s : Clinical Trials.gov ; NCT00381186 The EDIPS-Newcastle diabetes prevention study , Newcastle upon Tyne , UK : International St and ard R and omised Controlled Trial Number ; IS RCT N15670600 Abstract Background Diabetes prevalence is increasing . The Finnish Diabetes Prevention Study ( DPS ) showed a 58 % reduction in Type 2 Diabetes ( T2D ) incidence in adults with impaired glucose tolerance ( IGT ) . The European Diabetes Prevention Study ( EDIPS ) extends the DPS to different European population s , using the same study design . In the Newcastle arm of this study ( EDIPS-Newcastle ) , we tested the hypothesis that T2D can be prevented by lifestyle intervention and explored secondary outcomes in relation to diabetes incidence . Methods We recruited 102 participants ( 42 men and 60 women , mean age 57 years , mean BMI 34 kgm-2 ) with IGT to EDIPS-Newcastle and r and omised to Intervention and usual care Control groups . The intervention included individual motivational interviewing aim ed at : weight reduction , increase in physical activity , fibre and carbohydrate intake and reduction of fat intake ( secondary outcomes ) . The primary outcome was diagnosis of T2D . Results Mean duration of follow-up was 3.1 years . T2D was diagnosed in 16 participants ( I = 5 , C = 11 ) . Absolute incidence of T2D was 32.7 per 1000 person-years in the Intervention-group and 67.1 per 1000 person-years in the Control-group . The overall incidence of diabetes was reduced by 55 % in the Intervention-group , compared with the Control-group : RR 0.45 ( 95%CI 0.2 to 1.2).Explanatory survival analysis of secondary outcomes showed that those who sustained beneficial changes for two or more years reduced their risk of developing T2D . Conclusion Our results are consistent with other diabetes prevention trials . This study was design ed as part of a larger study and although the sample size limits statistical significance , the results contribute to the evidence that T2D can be prevented by lifestyle changes in adults with IGT . In explanatory analysis small sustained beneficial changes in weight , physical activity or dietary factors were associated with reduction in T2D incidence . Trial Registration International St and ard R and omised Controlled Trial Number registry ( IS RCT N)Registry number : IS RCT N 15670600 http://www.controlled-trials.com/is rct n/ search .html?srch=15670600%26sort=3%26dir = Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more OBJECTIVE Participants in the Diabetes Prevention Program ( DPP ) r and omized to intensive lifestyle modification ( ILS ) or metformin had a significantly reduced incidence of diabetes compared with those r and omized to placebo , yet most were still at risk because they had pre-diabetes . We explored the effect of baseline characteristics , weight change , ILS , and metformin on regression from pre-diabetes to the lowest-risk state of normal glucose regulation ( NGR ) defined by American Diabetes Association criteria . RESEARCH DESIGN AND METHODS The DPP was a prospect i ve r and omized trial . Cox proportional hazards modeling was used to identify predictors of regression from pre-diabetes to NGR over 3 years of follow-up . RESULTS Lower baseline fasting ( hazard ratio 1.52 , P < 0.01 ) and 2-h ( 1.24 , P < 0.01 ) glucose predicted regression to NGR , as did younger age ( 1.07 , P < 0.01 ) and greater insulin secretion ( 1.09 , P = 0.04 ) . ILS ( 2.05 , P < 0.01 ) and weight loss ( 1.34 , P < 0.01 ) had significant and independent effects on regression . A nonsignificant trend for regression was also observed for metformin ( 1.25 , P = 0.06 ) , male sex ( 1.17 , P = 0.08 ) , and insulin sensitivity ( 1.07 , P = 0.09 ) . In those entering the study with both impaired fasting glucose ( IFG ) and impaired glucose tolerance ( IGT ) , male sex and insulin sensitivity predicted regression to isolated IFG , whereas ILS , metformin , female sex , and greater insulin secretion predicted regression to isolated IGT . CONCLUSIONS Insulin secretion , and other biologic processes retained with younger age , are key in restoring NGR in people with pre-diabetes . However , NGR may also be attained through weight loss and additional aspects of ILS BACKGROUND Weight loss protects against type 2 diabetes but is hard to maintain with behavioral modification alone . In an analysis of data from a nonr and omized , prospect i ve , controlled study , we examined the effects of bariatric surgery on the prevention of type 2 diabetes . METHODS In this analysis , we included 1658 patients who underwent bariatric surgery and 1771 obese matched controls ( with matching performed on a group , rather than individual , level ) . None of the participants had diabetes at baseline . Patients in the bariatric-surgery cohort underwent b and ing ( 19 % ) , vertical b and ed gastroplasty ( 69 % ) , or gastric bypass ( 12 % ) ; nonr and omized , matched , prospect i ve controls received usual care . Participants were 37 to 60 years of age , and the body-mass index ( BMI ; the weight in kilograms divided by the square of the height in meters ) was 34 or more in men and 38 or more in women . This analysis focused on the rate of incident type 2 diabetes , which was a prespecified secondary end point in the main study . At the time of this analysis ( January 1 , 2012 ) , participants had been followed for up to 15 years . Despite matching , some baseline characteristics differed significantly between the groups ; the baseline body weight was higher and risk factors were more pronounced in the bariatric-surgery group than in the control group . At 15 years , 36.2 % of the original participants had dropped out of the study , and 30.9 % had not yet reached the time for their 15-year follow-up examination . RESULTS During the follow-up period , type 2 diabetes developed in 392 participants in the control group and in 110 in the bariatric-surgery group , corresponding to incidence rates of 28.4 cases per 1000 person-years and 6.8 cases per 1000 person-years , respectively ( adjusted hazard ratio with bariatric surgery , 0.17 ; 95 % confidence interval , 0.13 to 0.21 ; P<0.001 ) . The effect of bariatric surgery was influenced by the presence or absence of impaired fasting glucose ( P=0.002 for the interaction ) but not by BMI ( P=0.54 ) . Sensitivity analyses , including end-point imputations , did not change the overall conclusions . The postoperative mortality was 0.2 % , and 2.8 % of patients who underwent bariatric surgery required reoperation within 90 days owing to complications . CONCLUSIONS Bariatric surgery appears to be markedly more efficient than usual care in the prevention of type 2 diabetes in obese persons . ( Funded by the Swedish Research Council and others ; Clinical Trials.gov number , NCT01479452 . ) BACKGROUND Rosiglitazone is a thiazolidinedione that reduces insulin resistance and might preserve insulin secretion . The aim of this study was to assess prospect ively the drug 's ability to prevent type 2 diabetes in individuals at high risk of developing the condition . METHODS 5269 adults aged 30 years or more with impaired fasting glucose or impaired glucose tolerance , or both , and no previous cardiovascular disease were recruited from 191 sites in 21 countries and r and omly assigned to receive rosiglitazone ( 8 mg daily ; n=2365 ) or placebo ( 2634 ) and followed for a median of 3 years . The primary outcome was a composite of incident diabetes or death . Analyses were done by intention to treat . This trial is registered at Clinical Trials.gov , number NCT00095654 . FINDINGS At the end of study , 59 individuals had dropped out from the rosiglitazone group and 46 from the placebo group . 306 ( 11.6 % ) individuals given rosiglitazone and 686 ( 26.0 % ) given placebo developed the composite primary outcome ( hazard ratio 0.40 , 95 % CI 0.35 - 0.46 ; p<0.0001 ) ; 1330 ( 50.5 % ) individuals in the rosiglitazone group and 798 ( 30.3 % ) in the placebo group became normoglycaemic ( 1.71 , 1.57 - 1.87 ; p<0.0001 ) . Cardiovascular event rates were much the same in both groups , although 14 ( 0.5 % ) participants in the rosiglitazone group and two ( 0.1 % ) in the placebo group developed heart failure ( p=0.01 ) . INTERPRETATION Rosiglitazone at 8 mg daily for 3 years substantially reduces incident type 2 diabetes and increases the likelihood of regression to normoglycaemia in adults with impaired fasting glucose or impaired glucose tolerance , or both BACKGROUND It is not known whether drugs that block the renin-angiotensin system reduce the risk of diabetes and cardiovascular events in patients with impaired glucose tolerance . METHODS In this double-blind , r and omized clinical trial with a 2-by-2 factorial design , we assigned 9306 patients with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors to receive valsartan ( up to 160 mg daily ) or placebo ( and nateglinide or placebo ) in addition to lifestyle modification . We then followed the patients for a median of 5.0 years for the development of diabetes ( 6.5 years for vital status ) . We studied the effects of valsartan on the occurrence of three co primary outcomes : the development of diabetes ; an extended composite outcome of death from cardiovascular causes , nonfatal myocardial infa rct ion , nonfatal stroke , hospitalization for heart failure , arterial revascularization , or hospitalization for unstable angina ; and a core composite outcome that excluded unstable ang
Output:
| At meta-regression analysis , factors associated with effectiveness were weight loss , young age and fasting insulin levels .
These data indicate that several strategies , with different effectiveness , can prevent T2DM in obese subjects |
MS211662 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: International guidance has recently recommended serial proximal compression ultrasound ( CUS ) as first line imaging for suspected deep vein thrombosis ( DVT ) . Single whole‐leg CUS is a routine alternative diagnostic strategy that can reduce repeated attendances and identify alternative pathology . We conducted a prospect i ve observational cohort study . Consecutive ambulatory , adult patients with suspected DVT and negative or inconclusive whole‐leg CUS had anticoagulation withheld and were followed for 3 months . The primary outcome was a predefined clinical ly relevant adverse event rate . Secondary outcomes included technical failure , alternative diagnoses and all cause mortality . 212 patients agreed to participate and completed follow up . One patient was subsequently diagnosed with an isolated distal DVT . The adverse event rate was thus 1/212 , 0·47 % ( 95 % confidence interval [ CI ] 0·08–2·62 ) . Technical imaging failure occurred in 11·3 % of cases ( 95 % CI 7·7–16·3 ) . Several potential predictors of an inconclusive result were identified on multivariate analysis . 150 ( 70·8 % ) patients were provided with a documented alternative diagnosis . Patients who have anticoagulation withheld following a negative or inconclusive whole‐leg CUS for suspected DVT have a low rate of adverse events . Technical failure remains an issue : several factors were significantly associated with inconclusive results and may warrant an alternative diagnostic approach BACKGROUND It remains unclear whether a single complete ultrasound examination , which detects calf vein thrombosis , is as safe as a baseline rapid ultrasound examination , repeated after 1 week when negative , which examines the veins in the groin and the knee . Therefore , we compared the safety and feasibility of two diagnostic ultrasound strategies , involving rapid and complete compression ultrasound ( CUS ) examination . METHODS Consecutive patients with suspected deep vein thrombosis ( DVT ) underwent clinical probability assessment . In patients with an unlikely clinical probability and a normal D-dimer finding , DVT was considered to be excluded . All others were r and omized to undergo a rapid or a single complete CUS examination . Patients in whom DVT was excluded were followed for 3 months to assess the incidence of venous thromboembolism ( VTE ) . RESULTS A total of 1002 patients were included . A clinical decision rule indicating DVT to be unlikely and a normal D-dimer finding occurred in 481 patients ( 48 % ) , with a VTE incidence of 0.4 % [ 95 % confidence interval ( CI ) 0.05 - 1.5 % ] during follow-up . DVT was confirmed in 59 of the 257 patients ( 23 % ) who underwent rapid CUS examination , and in 99 of the 264 patients ( 38 % ) who underwent complete CUS examination . VTE during follow-up occurred in four patients ( 2.0 % ; 95 % CI 0.6 - 5.1 % ) in the rapid CUS arm , and in two patients ( 1.2 % ; 95 % CI 0.2 - 4.3 % ) in the complete CUS arm . CONCLUSIONS A diagnostic strategy with a clinical decision rule , a D-dimer test and a CUS examination is safe and efficient . Both the rapid and the complete CUS test are comparable and efficient strategies , with differing advantages and disadvantages BACKGROUND Several diagnostic strategies using ultrasound imaging , measurement of D-dimer , and assessment of clinical probability of disease have proved safe in patients with suspected deep-vein thrombosis , but they have not been compared in r and omized trials . METHODS Out patients presenting with suspected lower-extremity deep-vein thrombosis were potentially eligible . Using a clinical model , physicians evaluated the patients and categorized them as likely or unlikely to have deep-vein thrombosis . The patients were then r and omly assigned to undergo ultrasound imaging alone ( control group ) or to undergo D-dimer testing ( D-dimer group ) followed by ultrasound imaging unless the D-dimer test was negative and the patient was considered clinical ly unlikely to have deep-vein thrombosis , in which case ultrasound imaging was not performed . RESULTS Five hundred thirty patients were r and omly assigned to the control group , and 566 to the D-dimer group . The overall prevalence of deep-vein thrombosis or pulmonary embolism was 15.7 percent . Among patients for whom deep-vein thrombosis had been ruled out by the initial diagnostic strategy , there were two confirmed venous thromboembolic events in the D-dimer group ( 0.4 percent ; 95 percent confidence interval , 0.05 to 1.5 percent ) and six events in the control group ( 1.4 percent ; 95 percent confidence interval , 0.5 to 2.9 percent ; P=0.16 ) during three months of follow-up . The use of D-dimer testing result ed in a significant reduction in the use of ultrasonography , from a mean of 1.34 tests per patient in the control group to 0.78 in the D-dimer group ( P=0.008 ) . Two hundred eighteen patients ( 39 percent ) in the D-dimer group did not require ultrasound imaging . CONCLUSIONS Deep-vein thrombosis can be ruled out in a patient who is judged clinical ly unlikely to have deep-vein thrombosis and who has a negative D-dimer test . Ultrasound testing can be safely omitted in such patients The purpose of this study was to determine the effect of anticoagulation on the incidence of thrombotic propagation and pulmonary embolism in patients with calf vein thrombosis after total hip or total knee arthroplasty . Patients undergoing arthroplasties had prospect i ve surveillance for postoperative deep vein thrombosis by both bilateral contrast venography and venous duplex scanning . Calf vein thrombosis was documented by venography in 42 patients ( 50 limbs ) , including 29 of 253 patients undergoing total hip arthroplasty ( 11.4 % ) and 13 of 99 patients undergoing total knee arthroplasty ( 13 % ) . Of patients on whom follow-up duplex scans were performed , heparin followed by warfarin anticoagulation was used in 11 ( 13 limbs ) and withheld in 21 ( 25 limbs ) . Propagation of thrombosis to the popliteal or superficial femoral vein or both was detected by serial duplex scanning in 3 of 13 treated limbs ( 23 % ) and 2 of 25 untreated limbs ( 8 % ) , ( p = 0.43 ) . All thrombus propagations were detected within 2 weeks of the operative procedure . There were no pulmonary emboli or deaths . Propagation of asymptomatic calf vein thrombosis after arthroplasty was not influenced by anticoagulation , suggesting that postoperative calf vein thrombosis need not be routinely treated . Serial venous duplex scanning is useful to identify the occasional patient in whom thrombotic propagation requiring anticoagulation develops OBJECTIVE This prospect i ve study determined the incidence of signs and symptoms of chronic venous disease and recurrent venous thrombotic events ( VTE ) in relation to the location and extent of the initial venous thrombus . METHODS A first episode of acute deep vein thrombosis ( DVT ) occurred in 120 lower extremities of 105 patients ( 59 men ; mean age , 54 years [ range , 23 - 82 years ] ) . Patients who presented with pain , swelling , or signs and symptoms of pulmonary embolism of < 10 days were included . The DVT was diagnosed with duplex ultrasound ( DUS ) imaging . Patients were grouped by those having thrombosis in one venous segment ( group A ) or multiple levels ( group B ) . Patients were treated with heparin and warfarin . Patients with at least 1-year of follow-up with clinical and DUS were included . RESULTS No difference was found in the duration of signs and symptoms at presentation . The median follow-up was 3.4 years ( range , 1.2 - 7 years ) . More symptomatic limbs were seen in group B ( 71 of 79 ) compared with group A ( 21 of 41 ; P < .001 ) . Post-thrombotic syndrome ( PTS ) was more advanced in group B vs group A , including the prevalence of skin damage and ulceration ( 61 of 79 vs 26 of 41 , P < .001 ; 29 of 79 vs 6 of 41 , P = .019 , respectively ) . Limbs with calf DVT that had focal thrombosis were most often asymptomatic . Calf thrombosis in patients with proximal DVT produced the highest prevalence of PTS . Venous claudication was exclusively found in group B and was present only when iliac veins were involved . Recurrent thrombosis had a trend for a higher prevalence in group B ( 5 of 41 vs 16 of 79 , P = .39 ) . Reflux , obstruction , or a combination of the two were more common in group B ( 61 of 79 ) vs group A ( 15 of 41 ; P < .0001 ) . Limbs with both reflux and obstruction were more likely to develop skin damage ( group A , 5 of 6 vs 1 of 35 , P < .0001 ; group B , 24 of 29 vs 5 of 50 , P < .0001 ) . CONCLUSIONS Recurrent thrombosis and skin damage is more likely to develop in patients with multiple sites of thrombosis than in those with thrombosis in a single vein segment . Patients with reflux and obstruction presented more skin damage than those with reflux or obstruction alone . Involvement of the calf veins in the presence of proximal vein thrombosis increased the likelihood for PTS BACKGROUND Treatment of isolated calf muscle vein thrombosis ( ICMVT ) is controversial . There are no data from prospect i ve , controlled studies . Objective of this article was to compare the efficacy and safety of a short-term course of anticoagulation with compression therapy alone . METHODS We prospect ively r and omized patients with symptomatic , sonographically proven ICMVT in the soleal and /or gastrocnemial muscle veins in two treatment arms . The first received low-molecular-weight heparin for 10 days at therapeutic dosage ( nadroparin 180 anti-activated factor X units once daily ) and compression therapy for three months , and the second received compression therapy alone . Primary efficacy endpoint of the study was sonographically proven progression of ICMVT into the deep veins and clinical pulmonary embolism ( PE ) as confirmed by objective testing . Secondary efficacy and primary safety endpoints were major bleeding , death not due to PE , and complete sonographically proven recanalization of the muscle vein . We assessed transient and permanent risk factors for venous thromboembolism . RESULTS One-hundred seven patients were finally ruled eligible for evaluation : 89 % out patients , 11 % hospitalized patients . In the heparin group ( n=54 ) progression to deep vein thrombosis ( DVT ) occurred in two patients ( 3.7 % ) , in the group compression therapy alone ( n=53 ) progression to DVT occurred in two patients ( n.s . ) . No clinical PE and no death occurred . Thrombus recanalization after 3 months was not statistically significant different between the two study groups . No major bleeding occurred . CONCLUSION The data do not show superiority of a short-term regimen of low-molecular-weight heparin and compression therapy in comparison with compression therapy alone in patients with ICMVT in a rather low-risk population There is a lack of consensus on the value of detecting and treating symptomatic isolated distal deep-vein thrombosis ( DVT ) of the lower limbs . In our study , we compared the risk factors and outcomes in patients with isolated symptomatic distal DVT with those with proximal symptomatic DVT . We analysed the data of patients with objective ly confirmed symptomatic isolated DVT enrolled in the national ( France ) , multicenter , prospect i ve OPTIMEV study . This sub- study outcomes were recurrent venous thromboembolism , major bleeding and death at three months . Among the 6141 patients with suspicion of isolated DVT included between November 2004 and January 2006 , DVT was confirmed in 1643 patients ( 26.8 % ) . Isolated distal DVT was more frequent than proximal DVT ( 56.8 % vs. 43.2 % , respectively ; p = 0.01 ) . Isolated distal DVT was significantly more often associated with transient risk factors ( recent surgery , recent plaster immobilisation , recent travel ) , whereas proximal DVT was significantly more associated with more chronic states ( active cancer , congestive heart failure or respiratory insufficiency , age > 75 years ) . Most patients ( 96.8 % ) with isolated distal DVT received anticoagulant therapies . There was no difference in the percentage of recurrent venous thromboembolism and major bleeding in patients with proximal DVT and isolated distal DVT . However , the mortality rate was significantly higher ( p < 0.01 ) in patients with proximal DVT ( 8.0 % ) than in those with isolated distal DVT ( 4.4 % ) . Symptomatic isolated distal DVT differs from symptomatic proximal DVT both in terms of risk factors and clinical outcome . Whether these differences should influence the clinical management of these two events
Output:
| Anticoagulation may maximally benefit those patients with extensive and /or symptomatic disease or those with higher risk for complication ( unprovoked , cancer-associated or pregnancy ) |
MS211663 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The efficacy of clodronate to reduce bone loss around uncemented stems after total hip arthroplasty ( THA ) was evaluated . Ninety-one patients operated with uncemented THA were r and omized to receive either intramuscular clodronate at a dose of 100 mg weekly for 12 months or no treatment . Periprosthetic and contralateral bone mineral density ( BMD ) scans were performed and biochemical markers of bone turnover measured at baseline and at 3 , 6 , and 12 months . At month 12 , with the exception of Gruen zones 4 and 5 , patients treated with clodronate showed less bone loss at all zones , reaching statistical significance ( P < 0.05 ) in Gruen zones 2 and 6 ( difference of 6.6 and 5.9 % , respectively ) . Analysis of data according to gender revealed sex-related differences in bone loss and efficacy of treatment . After 12 months , the difference in bone loss between treated and untreated women in five out of seven Gruen zones ranged from 6.2 to 13.3 % ( SS at zones 2 and 6 ) , whereas comparison between treated and untreated men showed no BMD differences in all zones ( P > 0.05 ) . Median percent changes in serum levels of markers of bone metabolism by gender were consistent with BMD changes . A 1-year treatment with intramuscular clodronate determined a significant reduction of bone loss after THA . This was mainly attributed to its greater efficacy in the female population , which is at higher risk for bone loss . This observation suggests the need for the characterization of high-risk subjects as potential c and i date s for prevention strategies Summary Forty-three patients who had undergone cementless THA were r and omly assigned to receive no osteoactive drug or oral risedronate for 6 months . Postoperative decrease of BMD in the risedronate group was significantly lower than that seen in the control group in zones 1 , 2 , 3 , 6 , and 7 . Introduction Proximal bone resorption around the femoral stem often has been observed after total hip arthroplasty ( THA ) , could lead to late stem loosening . We previously reported the efficacy of etidronate on periprosthetic bone resorption after cementless THA . Recently risedronate is suggested to be effective for the prevention and treatment of for osteoporosis . The purpose of the present study was to evaluate the effects of risedronate on periprosthetic bone loss after cementless THA . Methods Forty-three patients who had undergone cementless THA were r and omly assigned to receive no osteoactive drug ( 21 patients ) or oral risedronate 2.5 mg/day ( 22 patients ) for 6 months . Three patients were eliminated from the risedronate group because of dyspepsia . Periprosthetic bone mineral density ( BMD ) in seven regions of interest based on the zones of Gruen et al. was measured with dual energy X-ray absorptiometry at 3 weeks and 6 months postoperatively . Results At 6 months after surgery , postoperative decrease of BMD in the risedronate group was significantly lower than that seen in the control group in zones 1 , 2 , 3 , 6 , and 7 ( p < 0.05 , p < 0.01 , p < 0.01 , p < 0.05 , and p < 0.05 , respectively ) . Conclusion These outcomes suggested that risedronate might reduce the periprosthetic bone resorption after cementless THA This r and omized trial evaluated the effect of zoledronic acid on femoral bone mineral density ( BMD ) following primary total hip arthroplasty . Bone mineral density was compared for up to 2years in 27 patients receiving 5 mg zoledronic acid intravenous infusion and in 24 patients receiving placebo at 2weeks and 1year after surgery . Zoledronic acid prevented loss of bone mineral density at 1year ( + 13.8 % vs + 1.4 % , P=.0065 ) and 2years ( + 14.3 % vs -4.0 % , P<.0001 ) in Gruen zone 1 , at 1year ( -8.4 % vs -25.4 % , P<.0001 ) and 2years ( -9.6 % vs -27.3 % , P<.0001 ) in Gruen zone 7 , at 6weeks , 6months , and 1 or 2years in Gruen zones 4 and 6 . For all Gruen zones , prevention of BMD loss by ZOL was significant at 6weeks , 6months , 1year ( + 0.80 % vs -6.03 % , P<.0001 ) and 2years ( -0.16 % vs -7.13 % , P<.0001 ) Background and Aims : Periprosthetic bone loss , especially in the proximal part of the femur , is common after cemented and uncemented total hip arthroplasty ( THA ) . Short-term studies suggest that bisphosponates can minimize this bone loss related to stress-shielding phenomenon . The aim of the present r and omized study was to investigate whether the positive effect of a 6 months alendronate treatment postoperatively still exists at five-year follow up . Material s and Methods : Sixteen uncemented primary THA patients were r and omized to receive either 10 mg alendronate + 500 mg calcium ( n = 7 ) or 500 mg calcium only ( n = 9 ) daily for 6 months postoperatively . Periprosthetic bone mineral density ( BMD ) was measured with the dual X-ray absorptiometry ( DXA ) postoperatively and at 6 , 12 , 24 , 36 and 60 months follow-up . Results : At the 5-year follow up , the calcium group showed mean BMD decreases of 23.1 % ( SD 14.6 ) in the proximal part of the femur ( prROI ) and 9.6 % ( SD 14.9 ) in total femoral regions of interest ( totROI ) . In the alendronate group the corresponding BMD decreases were 13.6 % ( SD 19.0 ) and 3.9 % ( SD 7.6 ) respectively . The positive effect of alendronate was already demonstrated during the first six months postoperatively . Subsequently the bone loss was equal in both groups , and the 5-year BMD changes were not significantly different between the groups . Conclusions : Alendronate seems to decrease early periprosthetic bone loss after arthroplasty but this pilot study could not provide enough evidence that the positive effect noted in the early postoperative period is still maintained 5 years after the operation BACKGROUND Bone mineral density ( BMD ) loss around femoral implants , particularly in the proximal femur , is a common outcome after total hip arthroplasty . Previous studies reported the prevention of postsurgical decrease in BMD with the use of osteoporosis drug therapy . This r and omized study evaluated the efficacy of alendronate and alfacalcidol for preserving BMD over a long-term follow-up . METHODS Sixty consecutive patients with hip osteoarthritis who had undergone primary cementless total hip arthroplasty were r and omly assigned to an alendronate ( n = 20 ) , alfacalcidol ( n = 18 ) , or control ( n = 22 ) group . Periprosthetic BMD was measured using dual-energy X-ray absorptiometry at 1 week , 1 year , and the current follow-up ( minimum 9 years after surgery ) . Changes in BMD are reported as mean percentages relative to the values at 1 week ( baseline reference ) . RESULTS All groups showed a significant decrease in the BMD of the calcar at the current follow-up compared to the values at both 1 week and 1 year postoperatively ( P < .001 ) . The BMD values were significantly higher in the alendronate group than in the alfacalcidol and control groups ( P < .05 ) . The BMD values at the current follow-up were 76 % ± 30 % ( alendronate group ) , 64 % ± 22 % ( alfacalcidol group ) , and 59 % ± 22 % ( control group ) of the baseline values . CONCLUSION Our findings demonstrate the efficacy of early administration of alendronate for the prevention of bone loss in the calcar region In this study the efficacy of an oral bisphosphonate therapy to inhibit wear debris mediated bone resorption was evaluated in a canine total hip replacement model . Adult canines were r and omized to three groups ( n = 8 each ) with a right uncemented total hip replacement performed on each animal . Group I ( control ) received no particulate debris . In Groups II and III , a mixture of 1 x 10(9 ) particles were introduced into the proximal femoral gap intraoperatively . The particle mixture consisted of fabricated ultra high molecular weight polyethylene ( mean 2.3 microns , 90 % by number ) , titanium alloy ( mean 3.1 microns , 5 % ) , and cobalt chrome alloy ( mean 0.8 micron , 5 % ) . Group III canines additionally received oral drug therapy ( 5 mg once a day , alendronate sodium ) which was begun on postoperative Day 7 and continued until the time of sacrifice . Postoperatively , all animals were allowed 24 weeks of full ambulation before euthanasia . Radiographs obtained preoperatively , postoperatively , and at time of sacrifice were evaluated for periprosthetic osteolysis . Interfacial tissues were examined histologically and placed in organ culture and the supernatants were assayed for prostagl and in E2 and interleukin-1 . One animal receiving debris ( Group II ) suffered a periprosthetic fracture and was sacrificed from the study . Radiographically , one of eight Group I ( control ) and six of seven canines from Group II ( debris ) had periprosthetic radiolucencies with endosteal scalloping develop . In contrast , only one of eight animals from Group III ( debris + alendronate ) had periprosthetic radiolucencies develop . Whereas tissues from control animals were mostly fibrous and acellular , tissues from both experimental groups had significant macrophage infiltration . Levels of prostagl and in E2 and interleukin-1 were elevated significantly in periprosthetic tissues from both experimental groups compared with controls . Continuous administration of alendronate effectively inhibited bone lysis for the 24-week duration of the study . This is consistent with the literature indicating that alendronate is incorporated in the mineralizing matrix making it refractory to osteoclastic resorption . This report has significant clinical implication s for controlling the most common cause of implant failure Background and purpose — We have previously shown that during the first 2 years after total hip arthroplasty ( THA ) , periprosthetic bone resorption can be prevented by 6 months of risedronate therapy . This follow-up study investigated this effect at 4 years . Patients and methods — A single-center , double-blind , r and omized placebo-controlled trial was carried out from 2006 to 2010 in 73 patients with osteoarthritis of the hip who were scheduled to undergo THA . The patients were r and omly assigned to receive either 35 mg risedronate or placebo orally , once a week , for 6 months postoperatively . The primary outcome was the percentage change in bone mineral density ( BMD ) in Gruen zones 1 and 7 in the proximal part of the femur at follow-up . Secondary outcomes included migration of the femoral stem and clinical outcome scores . Results — 61 of the 73 patients participated in this 4-year ( 3.9- to 4.1-year ) follow-up study . BMD was similar in the risedronate group ( n = 30 ) and the placebo group ( n = 31 ) . The mean difference was −1.8 % in zone 1 and 0.5 % in zone 7 . Migration of the femoral stem , the clinical outcome , and the frequency of adverse events were similar in the 2 groups . Interpretation — Although risedronate prevents periprosthetic bone loss postoperatively , a decrease in periprosthetic BMD accelerates when therapy is discontinued , and no effect is seen at 4 years . We do not recommend the use of risedronate following THA for osteoarthritis of the hip BACKGROUND Antiresorptive agents are widely used to treat osteoporosis . We report the results of a multinational r and omized , double-blind study , in which postmenopausal women with osteoporosis were treated with alendronate for up to 10 years . METHODS The initial three-year phase of the study compared three daily doses of alendronate with placebo . Women in the original placebo group received alendronate in years 4 and 5 and then were discharged . Women in the original active-treatment groups continued to receive alendronate during the initial extension ( years 4 and 5 ) . In two further extensions ( years 6 and 7 , and 8 through 10 ) , women who had received 5 mg or 10 mg of alendronate daily continued on the same treatment . Women in the discontinuation group received 20 mg of alendronate daily for two years and 5 mg daily in years 3 , 4 , and 5 , followed by five years of placebo . R and omized group assignments and blinding were maintained throughout the 10 years . We report results for the 247 women who participated in all four phases of the study . RESULTS Treatment with 10 mg of alendronate daily for 10 years produced mean increases in bone mineral density of 13.7 percent at the lumbar spine
Output:
| Conclusion BPs were beneficial to decreasing periprosthetic bone loss .
The third-generation BPs showed significantly efficacy for patients in short-term observation |
MS211664 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Two studies tested whether action control by implementation intentions is sensitive to the activation and strength of participants ’ underlying goal intentions . In Study 1 , participants formed implementation intentions ( or did not ) and their goal intentions were measured . Findings revealed a significant interaction between implementation intentions and the strength of respective goal intentions . Implementation intentions benefited the rate of goal attainment when participants had strong goal intentions but not when goal intentions were weak . Study 2 activated either a task-relevant or a neutral goal outside of participants ’ conscious awareness and found that implementation intentions affected performance only when the relevant goal had been activated . These findings indicate that the rate of goal attainment engendered by implementation intentions takes account of the state ( strength , activation ) of people ’s superordinate goal intentions Significance High attrition from educational programs is a major obstacle to social mobility and a persistent source of economic inefficiency . Over two-thirds of students entering a 2-y institution fail to earn a credential in the United States . In online courses , attrition rates are even higher . In two large field experiments , we tested the conditions under which a writing activity that facilitates goal commitment and goal -directed behavior reduces attrition in online courses . The activity raised completion rates by up to 78 % for members of individualist cultures and primarily for those who contended with predictable and surmountable obstacles in the form of everyday obligations , but it was ineffective in collectivist cultures and for people contending with other types of obstacles . Academic credentials open up a wealth of opportunities . However , many people drop out of educational programs , such as community college and online courses . Prior research found that a brief self-regulation strategy can improve self-discipline and academic outcomes . Could this strategy support learners at large scale ? Mental contrasting with implementation intentions ( MCII ) involves writing about positive outcomes associated with a goal , the obstacles to achieving it , and concrete if – then plans to overcome them . The strategy was developed in Western countries ( United States , Germany ) and appeals to individualist tendencies , which may reduce its efficacy in collectivist cultures such as India or China . We tested this hypothesis in two r and omized controlled experiments in online courses ( n = 17,963 ) . Learners in individualist cultures were 32 % ( first experiment ) and 15 % ( second experiment ) more likely to complete the course following the MCII intervention than a control activity . In contrast , learners in collectivist cultures were unaffected by MCII . Natural language processing of written responses revealed that MCII was effective when a learner ’s primary obstacle was predictable and surmountable , such as everyday work or family obligations but not a practical constraint ( e.g. , Internet access ) or a lack of time . By revealing heterogeneity in MCII ’s effectiveness , this research advances theory on self-regulation and illuminates how even highly efficacious interventions may be culturally bounded in their effects OBJECTIVE This study tested whether an intervention that combined information with self-regulation strategies had a better effect on eating fruits and vegetables than an information-only intervention . DESIGN Women between age 30 and 50 ( N = 255 ) participated in a 24-month r and omized controlled trial comparing two brief interventions : All participants received the same information intervention ; participants in the information plus self-regulation group additionally learned a self-regulation technique that integrates mental contrasting with implementation intentions . MAIN OUTCOME MEASURES Participants reported in daily diaries how many servings of fruits and vegetables they ate per day during 1 week at baseline , and in the first week , 1 , 2 , 4 , and 24 months after intervention . RESULTS Participants in both groups ate more fruits and vegetables ( 0.47 to 1.00 daily servings ) than at baseline during the first 4 months after intervention . Two years later , participants in the information plus self-regulation group maintained the higher intake , whereas participants in the information group returned to baseline levels . CONCLUSION Adding self-regulation training to an information intervention increased its effectiveness for long-term behavior change This study evaluates the effectiveness of an intervention based on the concept of implementation intentions for reducing dietary fat intake . Participants ( n=264 ) completed question naires on their motivation to eat a low-fat diet before being r and omized to either an experimental condition , which required them to form an implementation intention , or a control condition . Results showed that , after 1 month , fat intake , saturated fat intake , and the proportion of energy derived from fat decreased significantly in the experimental group but not in the control group . This difference could not be explained by differences in motivation between the 2 groups . The findings are discussed in relation to the use of implementation intentions instead of tailored interventions to change behavior in general population OBJECTIVE Fantasy realization theory ( Oettingen , 2012 ) proposes that fantasizing about a desired future or dwelling upon negative reality rarely changes behavior whereas mentally contrasting fantasy with reality can be an effective behavior change technique . This is because mental contrasting energizes people to overcome obstacles that st and in the way of their desired future . The present study tested whether mental contrasting promotes rates of physical activity among overweight , middle-aged , and low-SES men . METHOD A r and omized controlled trial was conducted with members of an angling club in the north of Engl and ( N = 467 ) . At baseline , participants completed a postal question naire that measured cognitions about physical activity . The intervention was embedded in the question naire for relevant participants . Behavior was followed up via telephone at 1 month and 7 months postbaseline . The key outcome measure was a vali date d , self-report measure of physical activity ( Godin , Jobin & Bouillon , 1986 ) taken at all three time-points . RESULTS Longitudinal , explanatory , and intention-to-treat analyses each indicated that mental contrasting was effective in enhancing rates of physical activity . Mental contrasting also aided the translation of beliefs about the value and worth of physical activity ( instrumental attitudes ) into action . CONCLUSION Mental contrasting appears to be an effective self-regulatory intervention for promoting physical activity and warrants further tests in health psychology Background Regular exercise can have positive effects on both the physical and mental health of individuals with schizophrenia . However , deficits in cognition , perception , affect , and volition make it especially difficult for people with schizophrenia to plan and follow through with their exercising intentions , as indicated by poor attendance and high drop-out rates in prior studies . Mental Contrasting and Implementation Intentions ( MCII ) is a well-established strategy to support the enactment of intended actions . This pilot study tests whether MCII helps people with schizophrenia in highly structured or autonomy-focused clinical hospital setting s to translate their exercising intentions into action . Methods Thirty-six in patients ( eleven women ) with a mean age of 30.89 years ( SD = 11.41 ) diagnosed with schizophrenia spectrum disorders from specialized highly structured or autonomy-focused wards were r and omly assigned to two intervention groups . In the equal contact goal intention control condition , patients read an informative text about physical activity ; they then set and wrote down the goal to attend jogging sessions . In the MCII experimental condition , patients read the same informative text and then worked through the MCII strategy . We hypothesized that MCII would increase attendance and persistence relative to the control condition over the course of four weeks and this will be especially be the case when applied in an autonomy-focused setting compared to when applied in a highly structured setting . Results When applied in autonomy-focused setting s , MCII increased attendance and persistence in jogging group sessions relative to the control condition . In the highly structured setting , no differences between conditions were found , most likely due to a ceiling effect . These results remained even when adjusting for group differences in the pre-intervention scores for the control variables depression ( BDI ) , physical activity ( IPAQ ) , weight ( BMI ) , age , and education . Whereas commitment and physical activity apart from the jogging sessions remained stable over the course of the treatment , depression and negative symptoms were reduced . There were no differences in pre-post treatment changes between intervention groups . Conclusions The intervention in the present study provides initial support for the hypothesis that MCII helps patients to translate their exercising intentions into real-life behavior even in autonomously-focused setting s without social control . Trial registration Clinical Trials.gov ID ; URL : NCT01547026 Registered 3 March 2012 Objective : Stroke is the most common cause of physical impairment , and having already had a stroke dramatically increases the risk of having another one . Although greater physical activity lowers rates of stroke recurrence , patients often fail to act in line with this recommendation . The present intervention tested whether teaching the self-regulation strategy of mental contrasting ( MC ) with implementation intentions ( II ; MCII ) improves stroke patients ’ physical activity and weight loss over 1 year compared with 2 information-only , control interventions . Research Method : Participants were 183 stroke survivors who were capable of adhering to physical activity recommendations ( age : M = 57 years ; body mass index ( BMI ): M = 30 ) . Patients were r and omized to 3 conditions : unstructured information ( n = 61 ) , structured information ( n = 62 ) , and structured information plus MCII ( n = 60 ) . Patients ’ physical activity was assessed 50 weeks after they had left the rehabilitation hospital using the Baecke Inventory ( Baecke , Burema , & Frijters , 1982 ) , and by diaries provided at 2 consecutive weekends after 0 , 10 , 20 , 30 , 40 , and 50 weeks . Diaries were also used to assess weight change . Results : MCII participants were more physically active after the 50 weeks ( Baecke Inventory : 2.74 vs. 2.59 , p < .05 ; diary : 62.45 vs. 54.11 , p = .03 ) and lost more weight ( 2.15 kg , p = .02 ) compared with participants in the control conditions . Conclusions : Teaching the MCII self-regulation strategy enhanced long-term physical activity in stroke patients relative to health information on its own . MCII thus qualifies as an effective intervention technique to improve secondary stroke prevention The current intervention tested whether a metacognitive self-regulatory strategy of goal pursuit can help economically disadvantaged children convert positive thoughts and images about their future into effective action . Mental contrasting with implementation intentions ( MCII ) entails mental contrasting a desired future with relevant obstacles of reality and forming implementation intentions ( if – then plans ) specifying when and where to overcome those obstacles . Seventy-seven 5th grade rs from an urban middle school were r and omly assigned to learn either MCII or a Positive Thinking control strategy . Compared to children in the control condition , children taught how to apply MCII to their academic wishes and concerns significantly improved their report card grade s ( η2 = .07 ) , attendance ( η2 = .05 ) , and conduct ( η2 = .07 ) . These findings suggest that MCII holds considerable promise for helping disadvantaged middle school children improve their academic performance & NA ; The present study tested a short intervention using goal ‐pursuit strategies to increase physical capacity in pain patients . Sixty chronic back pain patients were r and omly assigned to intervention or control conditions . Both groups followed a 3‐week conventional back pain program at an outpatient back pain center . Instead of routine treatment , the intervention group received a one‐hour intervention consisting of a combination of ( a ) a goal ‐ setting strategy ( i.e. , mental contrasting , MC ) aim ed at commitment to improved physical capacity , ( b ) a short cognitive behavioral therapy‐oriented problem‐solving approach ( CBT ) to help patients overcome the obstacles associated with improving physical capacity , and ( c ) a goal ‐pursuit strategy , i.e. , implementation intentions ( II ) aim ed at performing physical exercise regularly . At two follow‐ups ( 3 weeks after discharge and 3 months after returning home ) the MCII‐CBT group had increased its physical capacity significantly more than the control group as measured by both behavioral measures ( ergometer , lifting ) and subjective ratings . Findings are discussed with relation to the use of the intervention as a specific treatment to increase chronic pain patients ’ motivation to be physically active
Output:
| Mental contrasting shows promise as a brief behaviour change strategy with a significant small to moderate-sized effect on changing health behaviour in the short-term . |
MS211665 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Nearly 10 % of kidney transplant recipients in Western countries have chronic hepatitis C virus ( HCV ) infection ( 1 ) . The higher HCV prevalence in kidney transplant recipients than in the general population is a direct consequence of the association between HCV infection and kidney impairment as well as an increased risk for HCV infection acquired during hemodialysis or from blood transfused before routine HCV screening ( 2 , 3 ) . Chronic HCV infection increases the risk for end-stage renal disease ( 47 ) and , in kidney transplant patients , is associated with higher graft loss and mortality rates ( 810 ) . Treatment with interferon regimens has been limited because of the increased risk for interferon-mediated graft rejection and relatively low efficacy , result ing in an unacceptable riskbenefit ratio ( 8 , 11 ) . Direct-acting antiviral agents ( DAAs ) were developed that are highly effective against all HCV genotypes and seemed to be safe and effective in clinical trials as well as in studies of immunocompromised patients , such as orthotopic liver transplant recipients with HCV infection . Interest in using DAAs to treat HCV infection in kidney transplant patients has increased ; however , data regarding their use in this population are very limited ( 3 , 12 , 13 ) . In 2 small studies , treatment with a combination of DAAs for 12 weeks led to high rates of sustained virologic response ( SVR ) in kidney transplant recipients , with no significant adverse events or graft rejection noted ( 14 , 15 ) . In clinical trials , the fixed-dose combination of ledipasvir and sofosbuvir given for 12 or 24 weeks provided SVR rates ranging from 93 % to 99 % in treatment-naive and -experienced patients with HCV genotype 1 , 4 , 5 , or 6 infection ( 1620 ) . European and North American guidelines recommend as first-line options treatment with ledipasvirsofosbuvir for 12 weeks , along with ribavirin for patients without cirrhosis or with ribavirin for those with cirrhosis , or for 24 weeks without ribavirin in patients with cirrhosis who are intolerant or have a contraindication to ribavirin ( 21 , 22 ) . The high efficacy observed with fixed-dose ledipasvirsofosbuvir , even when not administered with ribavirin , represents a critical advantage for treating patients with impaired kidney function , avoiding the need for complicated ribavirin dosing strategies and assessment of ribavirin blood concentration . In addition , the lack of significant drugdrug interactions between ledipasvirsofosbuvir and immunosuppressant drugs and the absence of a clinical ly relevant effect of hepatic dysfunction on drug pharmacokinetics support its use in treating HCV recurrence after liver transplantation ( 23 , 24 ) . On the basis of these encouraging data , we conducted the first multinational , r and omized , controlled study to make an exploratory comparison of the efficacy and safety of 12 and 24 weeks of ledipasvirsofosbuvir without ribavirin in kidney transplant patients with chronic HCV genotype 1 or 4 infection . Supplement . Study Protocol Methods Setting and Participants Patients were enrolled at 5 clinical sites in 4 European countries : Italy , France , Austria , and Germany . Eligible patients were aged 18 years or older ; had chronic HCV genotype 1 or 4 infection , with plasma HCV RNA levels of 15 IU/mL or greater ; and had received a kidney transplant at least 6 months before the baseline study visit . Patients with compensated cirrhosis were eligible , with cirrhosis defined as a METAVIR score of 4 or an Ishak score of 5 or greater by biopsy , a FibroScan ( Echosens ) value greater than 12.5 kPa , or a FibroTest ( BioPredictive ) score greater than 0.75 plus an aspartate aminotransferaseplatelet ratio index greater than 2 . Patients were excluded from participation if they had a body mass index less than 18 kg/m2 ; decompensated liver disease ( that is , presence of ascites , encephalopathy , or variceal hemorrhage ) ; an electrocardiogram with clinical ly significant abnormalities ; HIV infection ; hepatitis B virus infection ; creatinine clearance less than 40 mL/min , as calculated by the CockcroftGault equation ; an albumin level lower than 30 g/L ; an international normalized ratio greater than 1.5 times the upper limit of normal ( unless the patient had hemophilia or was stable while receiving an anticoagulant regimen affecting international normalized ratio ) ; a hemoglobin level lower than 100 g/L ; a platelet level of 50109 cells/L or less ; a direct bilirubin level greater than 1.5 times the upper limit of normal , except for patients with Gilbert syndrome ; and an alanine aminotransferase , aspartate aminotransferase , or alkaline phosphatase level greater than 10 times the upper limit of normal . All patients provided written informed consent before undertaking any study -related procedures . Study Design Patients were r and omly assigned 1:1 to receive either 12 or 24 weeks of treatment with a fixed-dose combination of ledipasvir ( 90 mg ) and sofosbuvir ( 400 mg ) once daily by means of an integrated Web response system ( Bracket ) . A statistician employed by the sponsor generated the r and omization code by using SAS version 9.2 ( SAS Institute ) . R and omization was stratified by genotype , treatment history ( treatment naive or experienced ) , and the presence or absence of cirrhosis . Investigators , patients , and trial personnel were not blinded to treatment assignment . The study protocol was approved by each institution 's review board or ethics committee before study initiation . The study was conducted in accordance with the International Conference on Harmonisation ( ICH ) Good Clinical Practice Guidelines and the Declaration of Helsinki . All authors had access to the study data and review ed and approved the final manuscript before journal su bmi ssion . Study Assessment s Plasma HCV RNA was analyzed by using the COBAS AmpliPrep/COBAS TaqMan HCV Test , v2.0 ( Roche Molecular Systems ) , with a lower limit of quantification ( LLOQ ) of 15 IU/mL. Hepatitis C virus genotype and subtype were determined by using the Versant HCV Genotype INNO-LiPA 2.0 assay ( Siemens ) . An interleukin-28B genotype test was done through polymerase chain reaction amplification and sequencing of the rs12979860 single-nucleotide polymorphism . Plasma sample s for viral sequencing were collected at the same time points as those for HCV RNA levels . Deep sequencing of the NS5A and NS5B regions of the HCV RNA with MiSeq technology ( DDL Diagnostic Laboratory ) was performed on sample s collected from all patients at baseline and on posttreatment sample s from all patients with virologic failure . The result ing sequences were compared with reference sequences to determine the prevalence of resistance-associated substitutions ( RASs ) and the association of RASs with virologic outcomes . Resistance-associated substitutions present at more than 15 % of sequence reads are reported . Adverse events were recorded from day 1 of treatment until 30 days after the last dose ; serious adverse events and adverse events related to protocol -m and ated procedures were collected from screening through the last day of follow-up ( posttreatment week 24 ) or 30 days after the last dose . The data included reported adverse events as well as the results of physical examinations and clinical laboratory tests , vital signs , and electrocardiogram recordings . Treatment-emergent clinical and laboratory adverse events were summarized by using the Medical Dictionary for Regulatory Activities ( MedDRA ) , version 19.0 ( the MedDRA trademark is owned by the International Federation of Pharmaceutical Manufacturers and Associations on behalf of the ICH ) . Virologic relapse was defined as HCV RNA at the LLOQ or higher during the posttreatment period in a patient who had HCV RNA less than the LLOQ at the end of treatment . End Points and Statistical Analysis The primary efficacy end point was the percentage of patients with HCV RNA less than the LLOQ 12 weeks after stopping the study drug ( SVR12 ) . In the primary efficacy analysis , the SVR12 rate was calculated with a 2-sided 95 % exact CI by using the ClopperPearson method ( 25 ) . Patients with missing HCV RNA values at posttreatment week 12 who had posttreatment HCV RNA values less than the LLOQ before and after the missing posttreatment week 12 value were assumed to have achieved SVR12 . This study was exploratory in nature ; no inferential statistics or statistical comparisons were planned . The primary safety end point was any adverse event leading to permanent discontinuation of the study drug . We used SAS , version 9.2 , for all statistical analyses . Role of the Funding Source The sponsor design ed and conducted the study in collaboration with the principal investigators , collected the data , and monitored the study conduct . Results Study Population Of 130 patients screened , 16 ( 12.3 % ) were excluded : 11 did not meet eligibility criteria , 2 withdrew consent , and 3 were excluded because of existing clinical ly significant medical conditions ( atrial fibrillation , planned heart surgery , and hyponatremia with a urinary tract infection ) . A total of 114 patients were enrolled and treated at 5 sites in 4 European countries between 7 November 2014 and 16 June 2015 ( Appendix Figure ) . Overall , 94 % of the patients were white and 58 % were male ( Table 1 ) . Most were treatment naive ( 69 % ) , did not have cirrhosis ( 85 % ) , and had genotype 1 infection ( 91 % ) . Of the patients with genotype 1 infection , 75 % had genotype 1b infection . Appendix Figure . Patient disposition . LDVSOF = ledipasvirsofosbuvir . Table 1 . Demographic and Baseline Characteristics * Efficacy Ledipasvirsofosbuvir treatment result ed in rapid HCV RNA suppression ( Table 2 ) . By week 4 , 102 of 114 patients ( 89 % ) had HCV RNA less than the LLOQ ( with target not detectable in 68 % ) . By week 8 , all 113 evaluable patients ( 100 % [ excluding 1 patient in the 12-week group who discontinued study treatment at week 4 because of a serious adverse event ] ) had HCV RNA less than the LLOQ ( with target not detectable in 112 of 113 [ 99 % ] ) . At the end of treatment , BACKGROUND Chronic hepatitis C virus ( HCV ) infection is more prevalent among patients who have chronic kidney disease than among those who do not have the disease . Patients with chronic kidney disease who also have HCV infection are at higher risk for progression to end‐stage renal disease than those who have chronic kidney disease without HCV infection . Patients with both HCV infection and advanced chronic kidney disease have limited treatment options . METHODS We conducted a multicenter , open‐label , phase 3 trial to evaluate the efficacy and safety of treatment with the combination of the NS3/4A protease inhibitor glecaprevir and the NS5A inhibitor pibrentasvir for 12 weeks in adults who had HCV genotype 1 , 2 , 3 , 4 , 5 , or 6 infection and also had compensated liver disease ( with or without cirrhosis ) with severe renal impairment , dependence on dialysis , or both . Patients had stage 4 or 5 chronic kidney disease and either had received no previous treatment for HCV infection or had received previous treatment with interferon or pegylated interferon , ribavirin , sofosbuvir , or a combination of these medications . The primary end point was a sustained virologic response 12 weeks after the end of treatment . RESULTS Among the 104 patients enrolled in the trial , 52 % had genotype 1 infection , 16 % had genotype 2 infection , 11 % had genotype 3 infection , 19 % had genotype 4 infection , and 2 % had genotype 5 or 6 infection . The sustained virologic response rate was 98 % ( 102 of 104 patients ; 95 % confidence interval , 95 to 100 ) . No patients had virologic failure during treatment , and no patients had a virologic relapse after the end of treatment . Adverse events that were reported in at least 10 % of the patients were pruritus , fatigue , and nausea . Serious adverse events were reported in 24 % of the patients . Four patients discontinued the trial treatment prematurely because of adverse events ; three of these patients had a sustained virologic response . CONCLUSIONS Treatment with glecaprevir and pibrentasvir for 12 weeks result ed in a high rate of sustained virologic response in patients with stage 4 or 5 chronic kidney disease and HCV infection . ( Funded by AbbVie ; Clinical Trials.gov number , NCT02651194 . Well‐tolerated , ribavirin‐free , pangenotypic hepatitis C virus ( HCV ) treatments for transplant recipients remain a high priority . Once‐daily glecaprevir/pibrentasvir demonstrates high rates of sustained virologic response at 12 weeks posttreatment ( SVR12 ) across all major HCV genotypes ( GTs ) . This trial evaluated the safety and effic
Output:
| Acute HCV infection in hemodialysis units is identified by monitoring liver biochemical test results for increases above baseline , which may suggest acute HCV infection and prompt testing for HCV viremia several months before EIA testing shows positive results . |
MS211666 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Hypothermia therapy improves survival and the neurologic outcome in animal models of traumatic brain injury . However , the effect of hypothermia therapy on the neurologic outcome and mortality among children who have severe traumatic brain injury is unknown . METHODS In a multicenter , international trial , we r and omly assigned children with severe traumatic brain injury to either hypothermia therapy ( 32.5 degrees C for 24 hours ) initiated within 8 hours after injury or to normothermia ( 37.0 degrees C ) . The primary outcome was the proportion of children who had an unfavorable outcome ( i.e. , severe disability , persistent vegetative state , or death ) , as assessed on the basis of the Pediatric Cerebral Performance Category score at 6 months . RESULTS A total of 225 children were r and omly assigned to the hypothermia group or the normothermia group ; the mean temperatures achieved in the two groups were 33.1+/-1.2 degrees C and 36.9+/-0.5 degrees C , respectively . At 6 months , 31 % of the patients in the hypothermia group , as compared with 22 % of the patients in the normothermia group , had an unfavorable outcome ( relative risk , 1.41 ; 95 % confidence interval [ CI ] , 0.89 to 2.22 ; P=0.14 ) . There were 23 deaths ( 21 % ) in the hypothermia group and 14 deaths ( 12 % ) in the normothermia group ( relative risk , 1.40 ; 95 % CI , 0.90 to 2.27 ; P=0.06 ) . There was more hypotension ( P=0.047 ) and more vasoactive agents were administered ( P<0.001 ) in the hypothermia group during the rewarming period than in the normothermia group . Lengths of stay in the intensive care unit and in the hospital and other adverse events were similar in the two groups . CONCLUSIONS In children with severe traumatic brain injury , hypothermia therapy that is initiated within 8 hours after injury and continued for 24 hours does not improve the neurologic outcome and may increase mortality . ( Current Controlled Trials number , IS RCT N77393684 [ controlled-trials.com ] . ) BACKGROUND Induction of hypothermia in patients with brain injury was shown to improve outcomes in small clinical studies , but the results were not definitive . To study this issue , we conducted a multicenter trial comparing the effects of hypothermia with those of normothermia in patients with acute brain injury . METHODS The study subjects were 392 patients 16 to 65 years of age with coma after sustaining closed head injuries who were r and omly assigned to be treated with hypothermia ( body temperature , 33 degrees C ) , which was initiated within 6 hours after injury and maintained for 48 hours by means of surface cooling , or normothermia . All patients otherwise received st and ard treatment . The primary outcome measure was functional status six months after the injury . RESULTS The mean age of the patients and the type and severity of injury in the two treatment groups were similar . The mean ( + /-SD ) time from injury to r and omization was 4.3+/-1.1 hours in the hypothermia group and 4.1+/-1.2 hours in the normothermia group , and the mean time from injury to the achievement of the target temperature of 33 degrees C in the hypothermia group was 8.4+/-3.0 hours . The outcome was poor ( defined as severe disability , a vegetative state , or death ) in 57 percent of the patients in both groups . Mortality was 28 percent in the hypothermia group and 27 percent in the normothermia group ( P=0.79 ) . The patients in the hypothermia group had more hospital days with complications than the patients in the normothermia group . Fewer patients in the hypothermia group had high intracranial pressure than in the normothermia group . CONCLUSIONS Treatment with hypothermia , with the body temperature reaching 33 degrees C within eight hours after injury , is not effective in improving outcomes in patients with severe brain injury OBJECT This study was performed to determine whether mild hypothermia therapy is essential for the treatment of severely head injured patients in whom intracranial pressure ( ICP ) can be maintained below 20 mm Hg by using conventional therapies . METHODS Sixteen consecutive severely head injured patients fulfilled the following criteria : the patient 's ICP was maintained below 20 mm Hg by using fluid restriction , hyperventilation , and high-dose barbiturate therapy ; and the patient had a Glasgow Coma Scale score of 8 or less on admission . After conventional therapies had been applied , the patients were divided r and omly into two groups : the mild hypothermia group ( HT group ; eight patients ) and the normothermia group ( NT group ; eight patients ) . The HT group received mild hypothermia ( intracranial temperature 34 degrees C ) therapy for 48 hours followed by rewarming at 1 degree C per day for 3 days , whereas the NT group received normothermia ( intracranial temperature 37 degrees C ) therapy for 5 days . Specimens of cerebrospinal fluid ( CSF ) taken from an intraventricular catheter every 24 hours were analyzed for the presence of excitatory amino acids ( [ EAAs ] glutamate , aspartate , and glycine ) and cytokines ( tumor necrosis factor-alpha , interleukin [IL]-1beta , IL-6 , IL-8 , and IL-10 ) . The two groups did not differ significantly in patient age , neurological status , or level of ICP . There were no significant differences in daily changes in CSF concentrations of EAAs and cytokines between the two groups . The incidence of pneumonia was slightly higher in the HT group compared with the NT group ( p = 0.059 ) . The incidence of diabetes insipidus associated with hypernatremia was significantly higher in the HT group compared with that in the NT group ( p < 0.01 ) . The two groups did not differ with respect to their clinical outcomes . CONCLUSIONS The authors recommend normothermia therapy for the treatment of severely head injured patients in whom ICP can be maintained at lower than 20 mm Hg by using conventional therapies , because mild hypothermia therapy does not convey any advantage over normothermia therapy in such patients Animal research suggests that moderate therapeutic hypothermia may improve outcome after a severe head injury , but its efficacy has not been established in humans . The authors r and omly assigned 40 consecutively treated patients with a severe closed head injury ( Glasgow Coma Scale score 3 to 7 ) to either a hypothermia or a normothermia group . Using cooling blankets and cold saline gastric lavage , patients in the hypothermia group were cooled to 32 degrees to 33 degrees C ( brain temperature ) within a mean of 10 hours after injury , maintained at that temperature for 24 hours , and rewarmed to 37 degrees to 38 degrees C over 12 hours . Patients in the normothermia group were maintained at 37 degrees to 38 degrees C during this time . Deep-brain temperatures were monitored directly and used for all temperature determinations . Intracranial pressure ( ICP ) , cerebral blood flow ( CBF ) , and cerebral metabolic rate for oxygen ( CMRO2 ) were measured serially for all patients . Hypothermia significantly reduced ICP ( 40 % ) and CBF ( 26 % ) during the cooling period , and neither parameter showed a significant rebound increase after patients were rewarmed . Compared to the normothermia group , the mean CMRO2 in the hypothermia group was lower during cooling and higher 5 days after injury . Three months after injury , 12 of the 20 patients in the hypothermia group had moderate , mild , or no disabilities ; eight of the 20 patients in the normothermia group had improved to the same degree . Both groups had a similar incidence of systemic complications , including cardiac arrhythmias , coagulopathies , and pulmonary complications . It is concluded that therapeutic moderate hypothermia is safe and has sustained favorable effects on acute derangements of cerebral physiology and metabolism caused by severe closed head injury . The trend toward better outcome with hypothermia may indicate that its beneficial physiological and metabolic effects limit secondary brain injury OBJECTIVE To observe the changes of evoked potentials after severe brain injury and the effect of mild hypothermia on acute severe brain injury . METHODS A total of 44 patients with severe closed head injury ( GCS 3 - 8 , admitted within 10 hours from injury ) admitted from May 1998 to March 1999 were selected for this study . All patients were admitted into the intensive care unit and divided into 2 groups , Group A ( GCS 3 - 5 ) and Group B ( GCS 6 - 8 ) . Patients were also r and omly assigned to either normothermia or hypothermia subgroups . Patients in the hypothermia group were cooled to 32 - 34 degrees C. Median nerve short-latency somatosensory evoked potentials ( SLSEP ) and brain stem auditory evoked potentials ( BAEP ) were recorded before cooling and 4 , 24 , 48 , 72 , 96 and 120 hours , respectively after cooling and temperature resuming . SLSEP and BAEP were measured at the same time in the normothermia group ( control group ) . The changes of evoked potentials ( EP ) were analyzed by statistical methods . RESULTS In the Group B , N(20 ) amplitudes in SLSEP and I/V amplitudes in BAEP after mild hypothermia treatment in the hypothermia group differed significantly from those in the control group ( P<0.05 ) . However , in the Group A , no significant difference in all parameters was found . CONCLUSIONS These results demonstrate that mild hypothermia treatment ( 32 - 34 degrees C ) in the Group B has a significant neuroelectrophysiological effect on severe brain injury . Nevertheless , the effect of mild hypothermia in the Group A is not apparent and needs further study ing Recent experimental studies have demonstrated that mild hypothermia at about 34 degrees C can be effective in the control of intracranial hypertension . A r and omized controlled study of mild hypothermia was carried out in 33 severely head-injured patients . All patients fulfilled the following criteria : 1 ) persistent intracranial pressure ( ICP ) greater than 20 mm Hg despite fluid restriction , hyperventilation , and high-dose barbiturate therapy ; 2 ) an ICP lower than the mean arterial blood pressure ; and 3 ) a Glasgow Coma Scale score of 8 or less . The patients were divided into two groups : one received mild hypothermia ( 16 patients ) and one served as a control group ( 17 patients ) . Mild hypothermia significantly reduced the ICP and increased the cerebral perfusion pressure . Eight patients ( 50 % ) in the hypothermia group and three ( 18 % ) in the control group survived ( p < 0.05 ) , while five ( 31 % ) in the hypothermia group and 12 ( 71 % ) in the control group died of uncontrollable intracranial hypertension ( p < 0.05 ) . In five patients in the hypothermia group , cerebral blood flow was measured by the hydrogen clearance method and arteriojugular venous oxygen difference was evaluated before and during mild hypothermia . Mild hypothermia significantly decreased the cerebral blood flow , arteriojugular venous oxygen difference , and cerebral metabolic rate of oxygen ( p < 0.01 ) . The results of this preliminary investigation suggest that mild hypothermia is a safe and effective method to control traumatic intracranial hypertension and to improve mortality and morbidity rates OBJECTIVE To investigate the clinical characteristics and significance of thrombocytopenia after therapeutic hypothermia in severe traumatic brain injury ( TBI ) . METHODS Ninety-six in patients with severe brain injury were r and omized into three groups : SBC ( selective brain cooling ) group ( n=24 ) , MSH ( mild systemic hypothermia ) group ( n=30 ) , and control ( normothermia ) group ( n=42 ) . The platelet counts and prognosis were retrospectively analyzed . RESULTS Thrombocytopenia was present in 18 ( 75 % ) , 23 ( 77 % ) and 15 ( 36 % ) patients in SBC group , MSH group and control group , respectively ( P<0.01 ) . Thrombocytopenia , in which the minimum platelet count was seen 3 days after hypothermia , showed no significant difference between SBC and MSH group ( P>0.05 ) . Most platelet counts ( 37 cases , 90 % ) in hypothermia group were returned to normal level after 1 to 2 days of natural rewarming . The platelet count in SBC group reduced by 16 % , 27 % and 29 % at day 1 , 3 and 5 respectively compared with the baseline value . Good recovery ( GOS score 4 - 5 ) rate of thrombocytopenia 1 year after injury for hypothermia group ( 17 cases , 37 % ) was significantly lower than that of control group ( P<0.01 ) . CONCLUSIONS Therapeutic hypothermia increases the incidence of thrombocytopenia in severe TBI , and patients with thrombocytopenia after therapeutic hypothermia are associated with unfavorable neurological prognosis PURPOSE We investigated the effects of therapeutic mild hypothermia on patients with severe traumatic brain injury after craniotomy ( TBI ) . METHODS Eighty patients with severe TBI after unilateral craniotomy were r and omized into a therapeutic hypothermia
Output:
| There is no evidence that hypothermia is beneficial in the treatment of head injury .
The high quality trials found no decrease in the likelihood of death with hypothermia , but this finding was not statistically significant and could be due to the play of chance . |
MS211667 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Introduction Cefepime has been associated with a greater risk of mortality than other beta-lactams in patients treated for severe sepsis . Hypotheses for this failure include possible hidden side-effects ( for example , neurological ) or inappropriate pharmacokinetic/pharmacodynamic ( PK/PD ) parameters for bacteria with cefepime minimal inhibitory concentrations ( MIC ) at the highest limits of susceptibility ( 8 mg/l ) or intermediate-resistance ( 16 mg/l ) for pathogens such as Enterobacteriaceae , Pseudomonas aeruginosa and Staphylococcus aureus . We examined these issues in a prospect i ve non-interventional study of 21 consecutive intensive care unit ( ICU ) adult patients treated with cefepime for nosocomial pneumonia . Methods Patients ( median age 55.1 years , range 21.8 to 81.2 ) received intravenous cefepime at 2 g every 12 hours for creatinine clearance ( CLCr ) ≥ 50 ml/min , and 2 g every 24 hours or 36 hours for CLCr < 50 ml/minute . Cefepime plasma concentrations were determined at several time-points before and after drug administration by high-pressure liquid chromatography . PK/PD parameters were computed by st and ard non-compartmental analysis . Results Seventeen first-doses and 11 steady states ( that is , four to six days after the first dose ) were measured . Plasma levels varied greatly between individuals , from two- to three-fold at peak-concentrations to up to 40-fold at trough-concentrations . Nineteen out of 21 ( 90 % ) patients had PK/PD parameters comparable to literature values . Twenty-one of 21 ( 100 % ) patients had appropriate duration of cefepime concentrations above the MIC ( T > MIC ≥ 50 % ) for the pathogens recovered in this study ( MIC ≤ 4 mg/l ) , but only 45 to 65 % of them had appropriate coverage for potential pathogens with cefepime MIC ≥ 8 mg/l . Moreover , 2/21 ( 10 % ) patients with renal impairment ( CLCr < 30 ml/minute ) demonstrated accumulation of cefepime in the plasma ( trough concentrations of 20 to 30 mg/l ) in spite of dosage adjustment . Both had symptoms compatible with non-convulsive epilepsy ( confusion and muscle jerks ) that were not attributed to cefepime-toxicity until plasma levels were disclosed to the caretakers and symptoms resolved promptly after drug arrest . Conclusions These empirical results confirm the suspected risks of hidden side-effects and inappropriate PK/PD parameters ( for pathogens with upper-limit MICs ) in a population of ICU adult patients . Moreover , it identifies a safety and efficacy window for cefepime doses of 2 g every 12 hours in patients with a CLCr ≥ 50 ml/minute infected by pathogens with cefepime MICs ≤ 4 mg/l . On the other h and , prompt monitoring of cefepime plasma levels should be considered in case of lower CLCr or greater MICs EXECUTIVE SUMMARY Soft-tissue infections are common , generally of mild tomodest severity , and are easily treated with a variety ofagents . An etiologic diagnosis of simple cellulitis is fre-quently difficult and generally unnecessary for patients with mild signs and symptoms of illness . Clinical as-sessment of the severity of infection is crucial , and sev-eral classification schemes and algorithms have beenproposed to guide the clinician [ 1 ] . However , most clinical assessment s have been developed from eitherretrospective studies or from an author ’s own “ clinical experience , ” illustrating the need for prospect i ve studies with defined measurements of severity coupled to man-agement issues and outcomes .Until then , it is the recommendation of this com-mittee that patients with soft-tissue infection accom-panied by signs and symptoms of systemic toxicity ( e.g.,fever or hypothermia , tachycardia [ heart rate Cefepime is administered as an intermittent infusion ( II ) ; however , continuous infusion ( CI ) may be advantageous because β-lactam antibiotics exhibit time-dependent antibacterial activity . This retrospective , non-r and omised , comparative study included 68 neurosurgical patients with post-operative intracranial infections treated with 4g/day cefepime over 24h as a CI ( n=34 ) or 2 g every 12h as II ( n=34 ) . CI controlled the intracranial infection more rapidly and effectively than II ( 6.6±1.9 days vs. 7.8±2.6 days ; P=0.036 ) . By considering the minimum inhibitory concentrations ( MICs ) to be 4μg/mL and 8μg/mL , the percentage of time when the cefepime plasma or CSF concentrations were higher than the MIC ( % T > MIC ) was calculated for each patient . For plasma cefepime concentrations , the % T(>MIC ) in the CI group was higher than in the II group ( for MICs of 8μg/mL , 100 % vs. 75 % , respectively ) . The mean calculated area under the curve ( AUC ) in the CI group was similar to the II group ( 1197.99±72.15μgh/mL vs. 890.84±140.78μgh/mL ; P=0.655 ) . For CSF cefepime concentrations , the % T(>MIC ) in the CI group was higher than in the II group ( for MICs of 4μg/mL and 8μg/mL , 83.3 % and 75 % vs. 25 % and 0 % , respectively ) . The mean calculated AUC for the CI group was higher than the II group ( 220.56±13.59μgh/mL vs. 86.34±5.69μgh/mL ; P=0.003 ) . Therefore , CI of cefepime significantly enhanced the antibacterial effect and reduced the treatment duration in neurosurgical patients with post-operative intracranial infections Background : It is known that β-lactam antibiotics exhibit time-dependent bactericidal activity . Several studies have found continuous infusion of meropenem more effective than intermittent infusion in maintaining constant serum concentrations in excess of the minimum inhibitory concentration . However , limited data exist on the clinical efficacy of meropenem administered by continuous infusion . Objective : To evaluate the clinical efficacy of continuous versus intermittent infusion of meropenem for the treatment of ventilator-associated pneumonia ( VAP ) due to gram-negative bacilli . Methods : A retrospective cohort study was conducted of patients with VAP caused by gram-negative bacilli who received initial empiric antibiotic therapy with meropenem . We analyzed 2 contemporary cohorts : one group received meropenem by continuous infusion ( 1 g over 360 min every 6 h ) , the other by intermittent infusion ( 1 g over 30 min every 6 h ) . The administration method was prescribed according to the physician 's discretion . Patients received meropenem plus tobramycin for 14 days . Results : There were no significant differences between patient groups with regard to gender , age , APACHE-II at intensive care unit admission , diagnosis , microorganism responsible for VAP , or organ dysfunction severity at the time VAP was suspected . The group receiving medication by continuous infusion showed a greater clinical cure rate than the group treated with intermittent infusion ( 38 of 42 , 90.47 % , vs 28 of 47 , 59.57 % , respectively , with OR 6.44 [ 95 % Cl 1.97 to 21.05 ; p < 0.001 ] ) . Conclusions : Meropenem administered by continuous infusion may have more clinical efficacy than intermittent infusion The aim of this study was to compare the pharmacokinetic and pharmacodynamic parameters of a continuous infusion of cefepime vs. an intermittent regimen in critically ill adult patients with Gram-negative bacilli infection . The prospect i ve r and omized parallel study was carried out in 50 patients with severe pneumonia ( n = 41 ) or bacteremia ( n = 9 ) . They received cefepime 4 g/d either as a continuous infusion or intermittent administration 2 x 2 g in combination with amikacin . Patient characteristics and the minimal inhibitory concentration ( MIC ) of the isolated bacteria were comparable . Clinical outcomes were assessed along with pharmacodynamic indices and compared in both groups ( chi2 and Mann-Whitney U-tests ) . Mechanical ventilation , clinical outcome and bacteriological eradication did not significantly differ between the two groups . Also , the area under the plasma cefepime concentration curve at steady state ( AUCss : 612 + /- 369 vs. 623 + /- 319 mg x 1(-1 ) x h ) , AUCss > MIC ( 595 + /- 364 vs. 606 + /- 316 mg x 1(-1 ) x h ) and the area under the inhibitory concentration curve ( AUICss : 4258 + /- 5819 vs. 5194 + /- 7465 mg x 1(-1 ) x h ) were similar . If the time above MIC ( t > MIC ) was not significantly higher in Group 1 ( 100 + /- 0 % ) than in Group 2 ( 90 + /- 11 % ) , t > five-fold MIC in Group 1 ( 100 + /- 0 % ) was significantly higher ( p < 0.01 ) than in Group 2 ( 82 + /- 25 % ) . The mean time over the French breakpoint ( 4 mg/l ) was 100 + /- 0 % and 72 + /- 27 % in Group 1 and 2 ( p < 0.001 ) , respectively . In contrast to intermittent cefepime administration , continuous infusion of cefepime consistently maintained a serum concentration > 5 x the MIC of typical Gram-negative nosocomial pathogens . This results in greater bactericidal activity against organisms with a higher ( 2 mg/l ) cefepime breakpoint even if the clinical outcome is not significantly modified We conducted a prospect i ve , open-label study to delineate a relationship between exposure and outcomes in 36 patients treated with cefepime . Twenty patients had documented Gram-negative infections . Timed blood and urine sample s were obtained at steady state to determine pharmacokinetic and pharmacodynamic parameters . Microbiological success was significantly correlated with the proportion of the dosing interval that cefepime concentrations exceeded 4.3 x MIC . Our results support in vitro data that suggest bactericidal activity of beta-lactams is optimized at concentrations approximately 4 x MIC . These results should be vali date d by large prospect i ve clinical trials The objective of this study was to compare the pharmacokinetics of cefepime administered by continuous infusion and intermittent injection regimens . A prospect i ve , r and omized , cross-over study of ten patients with Gram-negative bacilli bacteraemia was conducted . All patients were r and omized to receive cefepime either as a 4-g continuous infusion over 24 h for 48 h or a 2-g bolus administered intermittently intravenously every 12 h for 48 h. After 48 h the patients received the alternative dose regimen . Cefepime pharmacokinetic studies were carried out during hours 36 - 48 after the start of both regimens . All of the pathogens isolated from the blood in 7 patients had a minimum inhibitory concentration ( MIC ) < 1 microg mL(-1 ) . In both regimens , the serum cefepime concentrations at all time points were higher than the MIC for the pathogens isolated from this study . For the continuous infusion arm , the highest steady-state concentration was 49.80+/-18.40 microg mL(-1 ) and the lowest steady-state concentration was 41.42+/-16.48 microg mL(-1 ) . The steady-state concentrations were greater than 4 times the MIC of 8 microg mL(-1 ) . For the intermittent injection regimen , the mean trough concentration was 4.74+/-3.99 microg mL(-1 ) . The mean serum cefepime concentration was above 8 microg mL(-1 ) for 81.66 % of the dosing interval . Therefore , we conclude that either continuous infusion or intermittent injection can be used as an effective mode of cefepime administration to achieve bactericidal activity ABSTRACT The pharmacokinetics of a 2-g bolus of cefepime were measured in critically ill patients with normal renal function . Variable and low trough plasma drug concentrations were found , and 8 of 10 patients had levels below the MIC at which 50 % of the isolates are inhibited forPseudomonas aeruginosa . Computer simulations predicted that continuous infusion and shorter dosing intervals would increase trough levels ABSTRACT A population pharmacokinetic model of cefepime was constructed from data from adult critical care patients with ventilator-associated pneumonia ( VAP ) . A total of 32 patients treated with high-dose cefepime , 2 g every 8 h ( 3-h infusion ) or a renal function-adjusted equivalent dose , were r and omized into two groups—26 for the initial model and 6 for model validation .
Output:
| Prolonged or continuous infusions of cefepime achieved the pharmacodynamic targets more often than traditional infusions .
The association of improved clinical outcomes with prolonged or continuous infusions is unclear .
Conclusions : The available literature on prolonged and continuous infusions of cefepime demonstrated an improved achievement of pharmacodynamic targets ; however , the effect on clinical outcomes is inconclusive . |
MS211668 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Obstructive airways disease in older patients is reported to be not only common , but frequently overlooked and untreated by general practitioners . This study examines the value of screening elderly patients in a large semi-rural general practice for potentially treatable asthma and chronic obstructive pulmonary disease ( COPD ) . METHODS A r and om sample of 353 patients aged 60–75 years attended a nurse run screening clinic for pulmonary function testing , serial peak flow recording , and completion of a symptom question naire . Patients with a low forced expiratory volume in one second ( below the fifth centile of their predicted value ) or > 15 % mean diurnal variation in peak flow were referred to a doctor ’s clinic for further diagnostic assessment and /or to discuss possible treatment where appropriate . RESULTS Fifty eight patients ( 16.4 % ) had obstructive airways disease , the prevalence of asthma being 6.5 % and that of COPD 9.9 % . Of these , 30 had no previous diagnosis of airways disease and were not on treatment ; eight of them had significant airways reversibility and 10 were current smokers . No newly diagnosed patients had severe disease as measured by pulmonary function or quality of life assessment , and six patients accepted treatment . CONCLUSION Few older patients benefited from a screening programme for obstructive airways disease in a semi-rural general practice OBJECTIVE The aim of this study was to compare the prevalence of adult respiratory symptoms and conditions in a rural setting with a metropolitan setting . METHODOLOGY We used cross-sectional population surveys of respiratory health using the European Respiratory Health Survey screening question naire . A r and om sample of 4455 eligible young adults aged 20 - 44 years , from electoral rolls in south-eastern metropolitan Melbourne , Victoria , and 4521 from rural south-western New South Wales were surveyed . RESULTS Response rates of 72 % ( n=3194 ) and 69 % ( n=3121 ) were achieved in Melbourne and the Riverina , respectively . Respondents from the Riverina reported significantly higher prevalences of nocturnal dyspnoea ( P<0.01 ) , chronic bronchitis ( P=0.03 ) , an asthma attack in the previous 12 months ( P<0.001 ) , ever having had asthma ( P<0.001 ) and doctor-diagnosed asthma ( P<0.001 ) compared to those from Melbourne . However , among those with ' asthma attacks in the last 12 months ' , Melbourne respondents experienced a higher frequency of attacks ( P<0.05 ) . Riverina respondents reported a higher prevalence of smoking ( P<0.05 ) and smoked more cigarettes on average ( P<0.001 ) than Melbourne respondents . However , annoyance from air pollution was higher in Melbourne than in the Riverina . CONCLUSIONS These results suggest that asthma is more prevalent in rural southern New South Wales than in Melbourne but follows a different pattern of exacerbations STUDY OBJECTIVE It is still unclear if men and women are equally susceptible to the hazards of tobacco smoking . The objective of this study was to examine smoking related mortality among men and women . DESIGN In 1963 a question naire concerning tobacco smoking habits was sent out to a r and om sample from the 1960 Swedish census population . Date and cause of death have been collected for the deceased in the cohort through 1996 . SETTING Sweden . PARTICIPANTS The survey included a total of 27 841 men and 28 089 women , aged 18–69 years . The response rate was 93.1 % among the men and 95.4 % among the women . MAIN RESULTS After adjustment for age and place of residence positive associations were found between cigarette smoking and mortality from ischaemic heart disease , aortic aneurysm , bronchitis and emphysema , cancer of the lung , upper aerodigestive sites , bladder , pancreas in both men and women , but not from cerebrovascular disease . When the effect of amount of the cigarette consumption was considered , female smokers displayed , for example , slightly higher relative death rates from ischaemic heart disease . However , no statistically significant gender differential in relative mortality rates was observed for any of the studied diseases . CONCLUSIONS Women and men in this Swedish cohort seem equally susceptible to the hazards of smoking , when the gender differential in smoking characteristics is accounted for . Although the cohort under study is large , there were few female smokers in the high consuming categories and the relative risk estimates are therefore accompanied by wide confidence intervals in these categories Background Exposure to environmental tobacco smoke ( ETS ) , which contains potent respiratory irritants , may lead to chronic airway inflammation and obstruction . Although ETS exposure appears to cause asthma in children and adults , its role in causing COPD has received limited attention in epidemiologic studies . Methods Using data from a population -based sample of 2,113 U.S. adults aged 55 to 75 years , we examined the association between lifetime ETS exposure and the risk of developing COPD . Participants were recruited from all 48 contiguous U.S. states by r and om digit dialing . Lifetime ETS exposure was ascertained by structured telephone interview . We used a st and ard epidemiologic approach to define COPD based on a self-reported physician diagnosis of chronic bronchitis , emphysema , or COPD . Results Higher cumulative lifetime home and work exposure were associated with a greater risk of COPD . The highest quartile of lifetime home ETS exposure was associated with a greater risk of COPD , controlling for age , sex , race , personal smoking history , educational attainment , marital status , and occupational exposure to vapors , gas , dusts , or fumes during the longest held job ( OR 1.55 ; 95 % CI 1.09 to 2.21 ) . The highest quartile of lifetime workplace ETS exposure was also related to a greater risk of COPD ( OR 1.36 ; 95 % CI 1.002 to 1.84 ) . The population attributable fraction was 11 % for the highest quartile of home ETS exposure and 7 % for work exposure . Conclusion ETS exposure may be an important cause of COPD . Consequently , public policies aim ed at preventing public smoking may reduce the burden of COPD -related death and disability , both by reducing direct smoking and ETS exposure Using the M.R.C. Question naire on Bronchitis and a question naire on smoking on a r and om sample of persons aged 62 and upwards , information was gathered about respiratorysymptoms and smoking habits . BACKGROUND Although many studies have examined the adverse health effects of pipe smoking combined with other forms of tobacco use , few have included large numbers of exclusive pipe smokers . The prevalence of pipe smoking has declined since the 1960s , yet usage is still common regionally , especially among older population s. METHODS Using Cox proportional hazards models , we examined the association between pipe smoking and mortality from tobacco-related cancers and other diseases in a cohort of U.S. men enrolled in the Cancer Prevention Study II , an American Cancer Society prospect i ve study . The cohort of 138 307 men included those who reported , in their 1982 enrollment question naire , exclusive current or former use of pipes ( n = 15,263 men ) or never use of any tobacco product ( n = 123,044 men ) . Analyses were based on 23 589 men who died during 18 years of follow-up . RESULTS Current pipe smoking , compared with never use of tobacco , was associated with an increased risk of death from cancers of the lung ( relative risk [ RR ] = 5.00 , 95 % confidence interval [ CI ] = 4.16 to 6.01 ) , oropharynx ( RR = 3.90 , 95 % CI = 2.15 to 7.08 ) , esophagus ( RR = 2.44 , 95 % CI = 1.51 to 3.95 ) , colorectum ( RR = 1.41 , 95 % CI = 1.15 to 1.73 ) , pancreas ( RR = 1.61 , 95 % CI = 1.24 to 2.09 ) , and larynx ( RR = 13.1 , 95 % CI = 5.2 to 33.1 ) , and from coronary heart disease ( RR = 1.30 , 95 % CI = 1.18 to 1.43 ) , cerebrovascular disease ( RR = 1.27 , 95 % CI = 1.09 to 1.48 ) , and chronic obstructive pulmonary disease ( RR = 2.98 , 95 % CI = 2.17 to 4.11 ) . These risks were generally smaller than those associated with cigarette smoking and similar to or larger than those associated with cigar smoking . Relative risks of lung cancer showed statistically significant increases with number of pipes smoked per day , years of smoking , and depth of inhalation and decreases with years since quitting . CONCLUSION Results from this large prospect i ve study suggest that pipe smoking confers a risk of tobacco-associated disease similar to cigar smoking OBJECTIVE To evaluate prospect ively the health risk of cigarette smoking in middle-aged men in Shanghai , China . DESIGN Prospect i ve cohort study with annual follow-up . PARTICIPANTS A total of 18 244 male residents of Shanghai , China , enrolled in the study during January 1 , 1986 , through September 30 , 1989 , and actively followed via annual visits . RESULTS By September 30 , 1993 , 852 deaths and 554 incident cancer cases were identified during the follow-up period , which averaged 5.4 years per subject . The overall incidence rate for cancer was 568 per 100 000 man-years , with the 3 leading sites being lung ( 146/100 000 ) , stomach ( 116/100 000 ) , and liver ( 81/100 000 ) . Forty-one percent of all deaths were from cancer . Stroke was the most frequent cause of death unrelated to cancer , with an age-adjusted rate 4.2 times higher than that of US white men ( 201/100 000 vs 48/100 000 ) , followed by ischemic heart disease , with an age-adjusted rate one-fifth that of US white men ( 69/100 000 vs 366/100 000 ) . Compared with lifelong nonsmokers , the relative risks in heavy smokers ( 20 or more cigarettes per day ) after adjustment for alcohol consumption were 2.2 for any incident cancer , 9.4 for incident lung cancer , 6.7 for head and neck cancer , and 1.8 for liver cancer . In terms of mortality , heavy smokers were at a 60 % greater risk of death relative to lifelong nonsmokers ; there was a 2.3-fold excess risk of death from cancer and 2-fold to 3-fold excess risk of death from heart disease . CONCLUSIONS Cigarette smoking is an important predictor of risk of cancer and mortality in men in Shanghai . Among the study subjects , 36 % of all cases of cancer and 21 % of all deaths could be attributed to cigarette smoking The present work aims to assess the international variation in the prevalence of chronic bronchitis and its main risk factor , smoking habits , in young adults of 35 centres from 16 countries . Respiratory symptoms and pulmonary function were assessed in 17,966 subjects ( 20 - 44 yrs ) , r and omly selected from the general population , in the frame of the European Community Respiratory Health Survey . The median prevalence of chronic bronchitis was 2.6 % , with wide variations across countries ( p<0.001 ; 0.7 - 9.7 % ) . The prevalence of current smokers ranged 20.1 - 56.9 % , ( p<0.001 ) with a median value of 40 % . Current smoking was the major risk factor for chronic bronchitis , especially in males . Its effect increased according to number of pack-yrs : in males , the odds ratio of chronic bronchitis was 3.51 ( 95 % confidence interval ( CI ) 2.31 - 5.32 ) in 1 - 14 pack-yrs smokers and increased to 17.32 ( 9.97 - 30.11 ) in > or = 45 pack-yrs smokers with respect to nonsmokers . Only 30 % of the geographical variability in prevalence could be explained by differences in smoking habits , suggesting that other environmental and /or genetic factors may play an important role . In conclusion , chronic bronchitis is a substantial health problem even in young adults . The impressive prevalence in current smokers in most countries highlights the need to improve the quality of prevention Background : Both chronic obstructive pulmonary disease ( COPD ) and obstructive sleep apnea syndrome ( OSAS ) are common diseases . Some recent studies suggest an increased prevalence of COPD among subjects with OSAS . Objectives : The study objective was to evaluate whether there is an epidemiological relationship between COPD and OSAS in a r and om population sample . Material s and Methods : The study population , 356 males ( 53 % ) and 320 females , mean age 56.6
Output:
| For COPD , RRs are higher for males , for studies conducted in North America , for cigarette smoking rather than any product smoking , and where the unexposed base is never smoking any product , and are markedly lower when asthma is included in the COPD definition .
Variations by sex , continent , smoking product and unexposed group are in the same direction for CB , but less clearly demonstrated .
For all outcomes RRs are higher when based on mortality , and for COPD are markedly lower when based on lung function .
For all outcomes , risk increases with amount smoked and pack-years .
Limited data show risk decreases with increasing starting age for COPD and CB and with increasing quitting duration for COPD .
No clear relationship is seen with duration of smoking .
Conclusions The results confirm and quantify the causal relationships with smoking |
MS211669 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: UNLABELLED Yttrium-90 radioembolization ( Y90RE ) is a novel approach to radiation therapy for hepatocellular carcinoma ( HCC ) , never tested in phase 2 studies . Fifty-two patients with intermediate ( n.17 ) to advanced ( n.35 ) HCC were prospect ively recruited to assess , as the primary endpoint , efficacy of Y90RE on time-to-progression ( TTP ) . Secondary endpoints were tumor response , safety , and overall survival ( OS ) . All patients were Eastern Cooperative Oncology Group ( ECOG ) score 0 - 1 , Child-Pugh class A-B7 . Y90RE treatments aim ed at a lobar delivery of 120 Gy . Retrospective dosimetric correlations were conducted and related to response . Fifty-eight treatments were performed on 52 patients . The median follow-up was 36 months . The median TTP was 11 months with no significant difference between portal vein thrombosis ( PVT ) versus no PVT ( 7 versus 13 months ) . The median OS was 15 months ( 95 % confidence interval [ CI ] , 12 - 18 months ) with a nonsignificant trend in favor of non-PVT versus PVT patients ( 18 versus 13 months ) . Five complete responses occurred ( 9.6 % ) , and the 2 year-progression rate was 62 % . Objective response was 40.4 % , whereas the disease control rate ( 78.8 % ) significantly affected survival ( responders versus nonresponders : 18.4 % versus 9.1 % ; P = 0.009 ) . Tumor response significantly correlated with absorbed dose in target lesions ( r = 0.60 , 95 % CI , 0.41 - 0.74 , P < 0.001 ) and a threshold of 500 Gy predicted response ( area under the curve , 0.78 ) . Mortality at 30 - 90 days was 0%-3.8 % . Various grade s of reduction in liver function occurred within 6 months in 36.5 % of patients , with no differences among stages . On multivariate analysis , tumor response was the sole variable affecting TTP ( P < 0.001 ) and the second affecting survival ( after Child-Pugh class ) . CONCLUSION Y90RE is an effective treatment in intermediate to advanced HCC , particularly in the case of PVT . Further prospect i ve evaluations comparing Y90RE with conventional treatments are warranted INTRODUCTION For patients with resectable hepatocellular carcinoma ( HCC ) , hepatectomy remains one of the best treatment options to provide long-term survival . However , more than 50 % of the patients have unresectable disease upon diagnosis even though there are no distant metastases . Transarterial chemoembolization ( TACE ) is a well-established treatment option that offers a palliative survival benefit for this group of patients . A better treatment for unresectable HCC has been sought after . There is some evidence that transarterial radioembolization ( TARE ) with the agent yttrium-90 produces encouraging outcomes , especially in patients with portal vein tumor thrombus . This study aims to analyze the outcomes of TARE at our center . METHODS From August 2009 to April 2013 , 16 patients underwent TARE at our center . Sixteen patients with similar tumor characteristics were selected to undergo TACE alone for comparison . A retrospective analysis of the prospect ively collected data of the patients was conducted . Only patients with newly diagnosed primary tumors were included in this study . RESULTS The median survival for patients having TARE was 19.9 versus 14.0 months in the TACE group ( P=0.615 ) . There was no difference in terms of tumor response according to the modified Response Evaluation Criteria in Solid Tumors ( mRECIST ) ( P=0.632 ) . The 1- , 2- and 3-year survival rates in the TARE group were 80.0 % , 30.5 % and 20.3 % respectively . The 1-year survival in the TACE group was 58.3 % ( P=0.615 ) . For patients who had major vascular invasion ( eight in each group ) , the 1- and 2-year survival rates in the TARE group were 62.5 % and 15.6 % respectively , while the 1-year survival in the TACE group was 35.0 % ( P=0.664 ) . CONCLUSIONS The two groups showed similar results in terms of tumor response and overall survival benefit . TARE might provide a survival benefit for patients with major vessel invasion BACKGROUND & AIMS To investigate the safety and adverse event profile of sorafenib plus radioembolization ( Y90 ) compared to Y90 alone in patients awaiting liver transplantation . METHODS 20 patients with HCC were r and omized to Y90 alone ( Group A ) or Y90+sorafenib ( Group B ) . Adverse events , dose reductions , and peri-transplant complications were assessed . RESULTS All patients in the sorafenib group necessitated dose reductions . Seventeen of 20 patients underwent liver transplantation ; median time-to-transplant was 7.8 months ( range : 4.2 - 20.3 ) and similar between groups ( p = 0.35 ) . In the sorafenib group , there were 4/8 peri-transplant ( < 30 days ) biliary complications ( p = 0.029 ) and 3/8 acute rejections ( p = 0.082 ) ; there were none in the Y90-only group . Survival rates were 70 % ( Group A ) and 72 % ( Group B ) at 3 years ( p = 0.57 ) . CONCLUSIONS The addition of sorafenib to Y90 necessitated dose reductions in all patients awaiting transplantation . Preliminary data suggest that the combination was associated with more peri-transplant biliary complications and potentially trended towards more acute rejections . Caution should be exercised when considering sorafenib in the transplant setting . Further investigation is warranted BACKGROUND The goal of this study was to examine the safety and efficacy of selective internal radioembolization ( SIR ) for hepatocellular carcinoma ( HCC ) with portal vein or caval thrombosis ( VT ) , or both . Recent reports have demonstrated that SIR is safe for patients with HCC , but the impact on efficacy of venous thrombosis is unknown . STUDY DESIGN Prospect i ve single-arm study of the use of Therasphere in patients with unresectable HCC enrolled from January 2004 to June 2007 . Patients were categorized into three groups based on VT status and therapy . RESULTS Fifty-two patients were enrolled : 20 patients without VT who received SIR , 15 patients with VT who were treated , and 17 patients ( 10 with VT ) who were not treated because of preprocedure screening failure . Fifty-eight treatments were administered , with a median of two treatments per patient ( range of one to three treatments ) . Child 's score was different between groups . Of the VT patients treated , 67 % had portal VT , 7 % had cava VT , and 26 % had both . There were no treatment-related deaths . There was no difference in complications among groups ( p = 0.34 ) . Treated patients without thrombosis had a median overall survival of 13.9 months versus 2.7 months for those treated with thrombosis and 5.2 months for the untreated group given best supportive care only ( p = 0.01 ) . CONCLUSIONS SIR is safe in patients with HCC . Although SIR can be delivered with minimal morbidity , there might be no benefit for patients with VT . Continued emphasis on multimodality therapy in this population is needed to improve survival UNLABELLED Radioembolization has been demonstrated to allow locoregional therapy of patients with hepatocellular carcinoma not eligible for transarterial chemoembolization or other local therapies . The aim of this study was to vali date evidence of the safety and efficacy of this treatment in a European sample of patients with advanced hepatocellular carcinoma ( HCC ) . Therefore , 108 consecutive patients with advanced HCC and liver cirrhosis were included . Yttrium-90 ( Y-90 ) microspheres were administered in a lobar fashion over the right or left branch of the hepatic artery . The response to treatment was evaluated by computed tomography ( CT ) imaging applying Response Evaluation Criteria in Solid Tumors ( RECIST ) and World Health Organization ( WHO ) criteria with recent European Association for the Study of the Liver / National Cancer Institute ( EASL/NCI ) amendments . Time to progression ( TTP ) and overall survival were estimated by the Kaplan-Meier method . In all , 159 treatment sessions were performed ranging between one to three treatments per patient . The mean radiation dose per treatment was 120 ( ± 18 ) Gy . According to EASL criteria , complete responses were determined in 3 % of patients , partial responses in 37 % , stable disease 53 % , and primary progression in 6 % of patients . TTP was 10.0 months , whereas the median overall survival was 16.4 months . No lung or visceral toxicity was observed . The most frequently observed adverse events was a transient fatigue-syndrome . CONCLUSION Radioembolization with Y-90 glass microspheres for patients with advanced HCC is a safe and effective treatment which can be utilized even in patients with compromised liver function . Because TTP and survival appear to be comparable to systemic therapy in selected patients with advanced HCC , r and omized controlled trials in combination with systemic therapy are warranted Background : Transcatheter arterial chemoembolisation ( TACE ) is the treatment of choice for intermediate stage hepatocellular carcinoma ( HCC ) . Doxorubicin-loaded drug-eluting beads (DEB)-TACE is expected to improve the performance of conventional TACE ( cTACE ) . The aim of this study was to compare DEB-TACE with cTACE in terms of time-to-tumour progression ( TTP ) , adverse events ( AEs ) , and 2-year survival . Methods : Patients were r and omised one-to-one to undergo cTACE or DEB-TACE and followed-up for at least 2 years or until death . Transcatheter arterial chemoembolisation was repeated ‘ on-dem and ’ . Results : We enrolled 177 patients : 89 underwent DEB-TACE and 88 cTACE . The median number of procedures was 2 in each arm , and the in-hospital stay was 3 and 4 days , respectively ( P=0.323 ) . No differences were found in local and overall tumour response . The median TTP was 9 months in both arms . The AE incidence and severity did not differ between the arms , except for post-procedural pain , more frequent and severe after cTACE ( P<0.001 ) . The 1- and 2-year survival rates were 86.2 % and 56.8 % after DEB-TACE and 83.5 % and 55.4 % after cTACE ( P=0.949 ) . Eastern Cooperative Oncology Group ( ECOG ) , serum albumin , and tumour number independently predicted survival ( P<0.05 ) . Conclusions : The DEB-TACE and the cTACE are equally effective and safe , with the only advantage of DEB-TACE being less post-procedural abdominal pain The objective of this study was to evaluate the response rate and survival of hepatocellular carcinoma portal vein thrombosis ( PVT ) patients treated with 90Y-loaded glass microspheres using a personalized dosimetry and intensification concept . Methods : The microspheres were administered to 41 hepatocellular carcinoma PVT patients ( main = 12 ; lobar/segmental = 29 ) . 99mTc-macroaggregated albumin SPECT/CT quantitative analysis was used to calculate the tumor dose ( TD ) , healthy injected liver dose ( HILD ) , and injected liver dose ( ILD ) . Response was evaluated at 3 mo using the criteria of the European Association for the Study of the Liver , with CT follow-up lasting until disease progression or death . Survival was assessed using the Kaplan – Meier method . Results : The mean injected activity was 3.1 ± 1.5 GBq , and mean ILD was 143 ± 49 Gy . When a TD threshold of 205 Gy was applied , 99mTc-macroaggregated albumin SPECT/CT achieved a 100 % sensitivity and 90 % overall accuracy ( 0 false-negatives ; 4 false-positives ) in response prediction . On the basis of TD and HILD values , 37 % of patients received an intensification of the treatment ( increased injected activity with the aim of achieving a TD ≥ 205 Gy and HILD < 120 Gy , applying an ILD > 150 Gy ) . This intensification result ed in a high response rate ( 85 % ) without increased liver toxicity of grade 3 or higher ( 6 % vs. 12 % in the patients who did not receive treatment intensification ; not statistically significant ) . For the total 41 patients , median overall survival ( OS ) was 18 mo ( 95 % confidence interval , 11–25 mo ) . For patients with a TD of less than 205 Gy , median OS was 4.3 mo ( 3.7–5 mo ) , versus 18.2 mo ( 8.5–28.7 mo ) for those with a TD of 205 Gy or more ( P = 0.005 ) . Median OS was 20.9 mo for patients with a
Output:
| Based on this evidence , until the results of the ongoing r and omized trials become available , radioembolization appears to be a viable treatment option for intermediate-advanced stage HCC |
MS211670 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: CONTEXT The worldwide explosive increase in type 2 diabetes mellitus and its cardiovascular morbidity are becoming major health concerns . OBJECTIVE To evaluate the effect of decreasing postpr and ial hyperglycemia with acarbose , an alpha-glucosidase inhibitor , on the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance ( IGT ) . DESIGN , SETTING , AND PARTICIPANTS International , multicenter double-blind , placebo-controlled , r and omized trial , undertaken in hospitals in Canada , Germany , Austria , Norway , Denmark , Sweden , Finl and , Israel , and Spain from July 1998 through August 2001 . A total of 1429 patients with IGT were r and omized with 61 patients ( 4 % ) excluded because they did not have IGT or had no postr and omization data , leaving 1368 patients for a modified intent-to-treat analysis . Both men ( 49 % ) and women ( 51 % ) participated with a mean ( SD ) age of 54.5 ( 7.9 ) years and body mass index of 30.9 ( 4.2 ) . These patients were followed up for a mean ( SD ) of 3.3 ( 1.2 ) years . INTERVENTION Patients with IGT were r and omized to receive either placebo ( n = 715 ) or 100 mg of acarbose 3 times a day ( n = 714 ) . MAIN OUTCOME MEASURES The development of major cardiovascular events ( coronary heart disease , cardiovascular death , congestive heart failure , cerebrovascular event , and peripheral vascular disease ) and hypertension ( > or = 140/90 mm Hg ) . RESULTS Three hundred forty-one patients ( 24 % ) discontinued their participation prematurely , 211 in the acarbose-treated group and 130 in the placebo group ; these patients were also followed up for outcome parameters . Decreasing postpr and ial hyperglycemia with acarbose was associated with a 49 % relative risk reduction in the development of cardiovascular events ( hazard ratio [ HR ] , 0.51 ; 95 % confidence interval [ CI ] ; 0.28 - 0.95 ; P = .03 ) and a 2.5 % absolute risk reduction . Among cardiovascular events , the major reduction was in the risk of myocardial infa rct ion ( HR , 0.09 ; 95 % CI , 0.01 - 0.72 ; P = .02 ) . Acarbose was also associated with a 34 % relative risk reduction in the incidence of new cases of hypertension ( HR , 0.66 ; 95 % CI , 0.49 - 0.89 ; P = .006 ) and a 5.3 % absolute risk reduction . Even after adjusting for major risk factors , the reduction in the risk of cardiovascular events ( HR , 0.47 ; 95 % CI , 0.24 - 0.90 ; P = .02 ) and hypertension ( HR , 0.62 ; 95 % CI , 0.45 - 0.86 ; P = .004 ) associated with acarbose treatment was still statistically significant . CONCLUSION This study suggests that treating IGT patients with acarbose is associated with a significant reduction in the risk of cardiovascular disease and hypertension BACKGROUND Improved blood-glucose control decreases the progression of diabetic microvascular disease , but the effect on macrovascular complications is unknown . There is concern that sulphonylureas may increase cardiovascular mortality in patients with type 2 diabetes and that high insulin concentrations may enhance atheroma formation . We compared the effects of intensive blood-glucose control with either sulphonylurea or insulin and conventional treatment on the risk of microvascular and macrovascular complications in patients with type 2 diabetes in a r and omised controlled trial . METHODS 3867 newly diagnosed patients with type 2 diabetes , median age 54 years ( IQR 48 - 60 years ) , who after 3 months ' diet treatment had a mean of two fasting plasma glucose ( FPG ) concentrations of 6.1 - 15.0 mmol/L were r and omly assigned intensive policy with a sulphonylurea ( chlorpropamide , glibenclamide , or glipizide ) or with insulin , or conventional policy with diet . The aim in the intensive group was FPG less than 6 mmol/L. In the conventional group , the aim was the best achievable FPG with diet alone ; drugs were added only if there were hyperglycaemic symptoms or FPG greater than 15 mmol/L. Three aggregate endpoints were used to assess differences between conventional and intensive treatment : any diabetes-related endpoint ( sudden death , death from hyperglycaemia or hypoglycaemia , fatal or non-fatal myocardial infa rct ion , angina , heart failure , stroke , renal failure , amputation [ of at least one digit ] , vitreous haemorrhage , retinopathy requiring photocoagulation , blindness in one eye , or cataract extraction ) ; diabetes-related death ( death from myocardial infa rct ion , stroke , peripheral vascular disease , renal disease , hyperglycaemia or hypoglycaemia , and sudden death ) ; all-cause mortality . Single clinical endpoints and surrogate sub clinical endpoints were also assessed . All analyses were by intention to treat and frequency of hypoglycaemia was also analysed by actual therapy . FINDINGS Over 10 years , haemoglobin A1c ( HbA1c ) was 7.0 % ( 6.2 - 8.2 ) in the intensive group compared with 7.9 % ( 6.9 - 8.8 ) in the conventional group -- an 11 % reduction . There was no difference in HbA1c among agents in the intensive group . Compared with the conventional group , the risk in the intensive group was 12 % lower ( 95 % CI 1 - 21 , p=0.029 ) for any diabetes-related endpoint ; 10 % lower ( -11 to 27 , p=0.34 ) for any diabetes-related death ; and 6 % lower ( -10 to 20 , p=0.44 ) for all-cause mortality . Most of the risk reduction in the any diabetes-related aggregate endpoint was due to a 25 % risk reduction ( 7 - 40 , p=0.0099 ) in microvascular endpoints , including the need for retinal photocoagulation . There was no difference for any of the three aggregate endpoints between the three intensive agents ( chlorpropamide , glibenclamide , or insulin ) . Patients in the intensive group had more hypoglycaemic episodes than those in the conventional group on both types of analysis ( both p<0.0001 ) . The rates of major hypoglycaemic episodes per year were 0.7 % with conventional treatment , 1.0 % with chlorpropamide , 1.4 % with glibenclamide , and 1.8 % with insulin . Weight gain was significantly higher in the intensive group ( mean 2.9 kg ) than in the conventional group ( p<0.001 ) , and patients assigned insulin had a greater gain in weight ( 4.0 kg ) than those assigned chlorpropamide ( 2.6 kg ) or glibenclamide ( 1.7 kg ) . INTERPRETATION Intensive blood-glucose control by either sulphonylureas or insulin substantially decreases the risk of microvascular complications , but not macrovascular disease , in patients with type 2 diabetes . ( ABSTRACT TRUNCATED Background —Postpr and ial hyperglycemia may be a risk factor for cardiovascular disease . We compared the effects of two insulin secretagogues , repaglinide and glyburide , known to have different efficacy on postpr and ial hyperglycemia , on carotid intima-media thickness ( CIMT ) and markers of systemic vascular inflammation in type 2 diabetic patients . Methods and Results —We performed a r and omized , single-blind trial on 175 drug-naive patients with type 2 diabetes mellitus ( 93 men and 82 women ) , 35 to 70 years of age , selected from a population of 401 patients who participated in an epidemiological analysis assessing the relation of postpr and ial hyperglycemia to surrogate measures of atherosclerosis . Eighty-eight patients were r and omly assigned to receive repaglinide and 87 patients to glyburide , with a titration period of 6 to 8 weeks for optimization of drug dosage and a subsequent 12-month treatment period . The effects of repaglinide ( 1.5 to 12 mg/d ) and glyburide ( 5 to 20 mg/d ) on CIMT were compared by using blinded , serial assessment s of the far wall . After 12 months , postpr and ial glucose peak was 148±28 mg/dL in the repaglinide group and 180±32 mg/dL in the glyburide group ( P < 0.01 ) . HbA1c showed a similar decrease in both groups ( −0.9 % ) . CIMT regression , defined as a decrease of > 0.020 mm , was observed in 52 % of diabetics receiving repaglinide and in 18 % of those receiving glyburide ( P < 0.01 ) . Interleukin-6 ( P = 0.04 ) and C-reactive protein ( P = 0.02 ) decreased more in the repaglinide group than in the glyburide group . The reduction in CIMT was associated with changes in postpr and ial but not fasting hyperglycemia . Conclusions —Reduction of postpr and ial hyperglycemia in type 2 diabetic patients is associated with CIMT regression BACKGROUND New diagnostic criteria for diabetes based on fasting blood glucose ( FBG ) level were approved by the American Diabetes Association . The impact of using FBG only has not been evaluated thoroughly . The fasting and the 2-hour glucose ( 2h-BG ) criteria were compared with regard to the prediction of mortality . METHODS Existing baseline data on glucose level at fasting and 2 hours after a 75-g oral glucose tolerance test from 10 prospect i ve European cohort studies including 15 388 men and 7126 women aged 30 to 89 years , with a median follow-up of 8.8 years , were analyzed . Hazards ratios for death from all causes , cardiovascular disease , coronary heart disease , and stroke were estimated . RESULTS Multivariate Cox regression analyses showed that the inclusion of FBG did not add significant information on the prediction of 2h-BG alone ( P>.10 for various causes ) , whereas the addition of 2h-BG to FBG criteria significantly improved the prediction ( P<.001 for all causes and P<.005 for cardiovascular disease ) . In a model including FBG and 2h-BG simultaneously , hazards ratios ( 95 % confidence intervals ) in subjects with diabetes on 2h-BG were 1.73 ( 1.45 - 2.06 ) for all causes , 1.40 ( 1.02 - 1.92 ) for cardiovascular disease , 1.56 ( 1.03 - 2.36 ) for coronary heart disease , and 1.29 ( 0.66 - 2.54 ) for stroke mortality , compared with the normal 2h-BG group . Compared with the normal FBG group , the corresponding hazards ratios in subjects with diabetes on FBG were 1.21 ( 1.01 - 1.44 ) , 1.20 ( 0.88 - 1.64 ) , 1.09 ( 0.71 - 1.67 ) , and 1.64 ( 0.88 - 3.07 ) , respectively . The largest number of excess deaths was observed in subjects who had impaired glucose tolerance but normal FBG levels . CONCLUSION The 2h-BG is a better predictor of deaths from all causes and cardiovascular disease than is FBG Summary The Diabetes Intervention Study ( DIS ) is a prospect i ve population -based multicentre trial of newly detected cases of non-insulin-dependent diabetes mellitus ( NIDDM ) . This report analyses the risk factors for subsequent coronary heart disease and all-cause death during the 11-year follow-up . The prognostic significance of the categories of the NIDDM Policy Group was vali date d with respect to the incidence of coronary heart disease and mortality . At baseline 1139 subjects , aged 30–55 years at the time of diabetes detection and classified as diet controlled after a 6-week screening phase , were included . Of the patients 112 ( 15.2 % ) suffered from myocardial infa rct ion , 197 ( 19.82 % ) of 994 had died . The odds ratio for all-cause mortality compared to the general population for males at the age of 36–45 years was 5.1 and for females 7.0 . In multivariate analysis age , blood pressure and smoking were independent risk factors for myocardial infa rct ion and male sex , age , blood pressure , triglycerides , postpr and ial blood glucose and smoking for death , respectively . The categories of the NIDDM Policy Group target parameters for blood glucose , triglycerides and blood pressure were significant predictors of both CHD and death . Thus , it appears
Output:
| Despite this , the few available studies show that higher PPG is associated with increased all-cause and cardiovascular death , incidence of major cardiovascular events ( including myocardial infa rct ion and stroke ) , and progression of diabetic retinopathy |
MS211671 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Unfractionated heparin and the low molecular weight heparin , dalteparin , are used for prophylaxis against venous thromboembolism in patients undergoing craniotomy . These drugs were compared in a r and omized , prospect i ve pilot study comparing intermittent pneumatic compression devices plus dalteparin to intermittent pneumatic compression devices plus heparin . METHODS One hundred patients undergoing craniotomy were r and omly allocated to receive perioperative prophylaxis with subcutaneous ( SC heparin , 5000 units every 12 hours , or dalteparin , 2,500 units once a day , begun at induction of anesthesia and continued for 7 days or until the patient was ambulating . Entry criteria were age over 18 years , no deep vein thrombosis ( DVT ) preoperatively as judged by lower limb duplex ultrasound and no clinical evidence of pulmonary embolism preoperatively . Patients with hypersensitivity to heparin , penetrating head injury or who refused informed consent were excluded . Patients underwent a duplex study 1 week after surgery and 1 month clinical follow-up . All patients were treated with lower limb intermittent pneumatic compression devices . RESULTS There were no differences between groups in age , gender , and risk factors for venous thromboembolism . There were no differences between groups in intraoperative blood loss , transfusion requirements or postoperative platelet counts . Two patients receiving dalteparin developed DVT ( one symptomatic and one asymptomatic ) . No patient treated with heparin developed DVT and no patient in either group developed pulmonary embolism . There were two hemorrhages that did not require repeat craniotomy in patients receiving dalteparin and one that did require surgical evacuation in a patient treated with heparin . Drug was stopped in two patients treated with dalteparin because of thrombocytopenia . None of these differences were statistically significant . CONCLUSION There was no significant difference in postoperative hemorrhage , venous thromboembolism or thrombocytopenia between heparin and dalteparin . The results suggest that , given the small sample size of this trial , both drugs appear to be safe and the incidence of venous thromboembolism by postoperative screening duplex ultrasound appears to be low when these agents are used in combination with intermittent pneumatic compression devices BACKGROUND Current treatment regimens that are design ed to prevent deep venous thrombosis in patients undergoing orthopaedic procedures rely predominantly on drug prophylaxis alone . The purpose of this r and omized clinical study was to evaluate the effectiveness of a mechanical adjunct to chemoprophylaxis that involves intermittent compression of the legs . METHODS During a twenty-two month period , 1803 patients undergoing a variety of orthopaedic procedures were prospect ively r and omized to receive either chemoprophylaxis alone or a combination of chemoprophylaxis and mechanical prophylaxis . Nine hundred and two patients were managed with low-molecular-weight heparin alone , and 901 were managed with low-molecular-weight heparin and intermittent pneumatic compression of the calves for varying time periods . Twenty-four percent of the patients underwent total hip or knee joint replacement . Screening for deep venous thrombosis was performed on the day of discharge with duplex-color-coded ultrasound . RESULTS In the chemoprophylaxis-only group , fifteen patients ( 1.7 % ) were diagnosed with a deep venous thrombosis ; three thromboses were symptomatic . In the chemoprophylaxis plus intermittent pneumatic compression group , four patients ( 0.4 % ) were diagnosed with deep venous thrombosis ; one thrombosis was symptomatic . The difference between the groups with regard to the prevalence of deep venous thrombosis was significant ( p = 0.007 ) . In the chemoprophylaxis plus intermittent pneumatic compression group , no deep venous thromboses were found in patients who received more than six hours of intermittent pneumatic compression daily . CONCLUSIONS Venous thrombosis prophylaxis with low-molecular-weight heparin augmented with a device that delivers rapid-inflation intermittent pneumatic compression to the calves was found to be significantly more effective for preventing deep venous thrombosis when compared with a treatment regimen that involved low-molecular-weight heparin alone Objective To compare the effectiveness and safety of low-dose unfractionated heparin and a low-molecular-weight heparin as prophylaxis against venous thromboembolism after colorectal surgery . Methods In a multicenter , double-blind trial , patients undergoing resection of part or all of the colon or rectum were r and omized to receive , by subcutaneous injection , either calcium heparin 5,000 units every 8 hours or enoxaparin 40 mg once daily ( plus two additional saline injections ) . Deep vein thrombosis was assessed by routine bilateral contrast venography performed between postoperative day 5 and 9 , or earlier if clinical ly suspected . Results Nine hundred thirty-six r and omized patients completed the protocol and had an adequate outcome assessment . The venous thromboembolism rates were the same in both groups . There were no deaths from pulmonary embolism or bleeding complications . Although the proportion of all bleeding events in the enoxaparin group was significantly greater than in the low-dose heparin group , the rates of major bleeding and reoperation for bleeding were not significantly different . Conclusions Both heparin 5,000 units subcutaneously every 8 hours and enoxaparin 40 mg subcutaneously once daily provide highly effective and safe prophylaxis for patients undergoing colorectal surgery . However , given the current differences in cost , prophylaxis with low-dose heparin remains the preferred method at present We initiated a prospect i ve , partially r and omized trial of the effects of perioperative prophylactic mini-dose heparin on the incidence of clinical ly evident pulmonary emboli , intraoperative blood loss , blood transfusions , duration of postoperative pelvic drainage , and lymphocele formation in 68 consecutive patients undergoing radical retropubic prostatectomy . We treated 32 patients with mini-dose heparin and 36 without it . We detected pulmonary emboli in 4 ( 11 % ) patients not treated with mini-dose heparin and in none treated with heparin ( p = 0.052 ) . Anesthesiologists estimated a mean intraoperative blood loss of 2,152 cc in the heparinized patients compared with 1,886 cc in controls ( p = 0.2 ) . At a time when our policy was to replace all blood loss , we transfused a mean of 3.9 units to heparinized patients and 3.2 units to controls ( p = 0.1 ) . Persistent lymphatic drainage requiring more than six days of closed suction drainage occurred in 12 of 32 ( 38 % ) heparinized patients as compared with 4 of 36 ( 11 % ) controls ( p = 0.01 ) . We discontinued the study after 68 patients because of the morbidity associated with mini-dose heparin . Because of the associated morbidity we do not recommend the routine use of mini-dose heparin in patients undergoing radical prostatectomy The possible benefits of adding a low-dose heparin regimen to the technique of peroperative intermittent calf compression for preventing deep vein thrombosis ( D.V.T. ) were assessed in a r and omized trial in 84 surgical patients . The efficacy of peroperative intermittent calf compression was not enhanced by a low-dose heparin regimen , but neither was it worsened . Age , weight , duration , operation , and malignant disease did not affect the relative effectiveness of the two regimens of prophylaxis . The results confirmed that venous stasis is the principal cause of INTRODUCTION Pneumatic compression stocking ( PCS ) devices have been introduced to decrease the incidence of postoperative deep venous thrombosis ( DVT ) . However , their role in the prophylaxis against pulmonary embolism ( PE ) remains unclear . This study was undertaken to compare the prophylactic effectiveness of subcutaneous heparin ( SCH ) alone vs the combined use of PCS and SCH in the prevention of PE following cardiac surgery . METHODS We studied 2,551 consecutive patients who underwent cardiac surgery over a 10-year period . They were r and omly allocated to two groups . Group A included 1,196 patients who were treated with 5,000 U of SCH every 12 h and group B included 1,355 patients treated with a combined prophylactic regimen of PCS and SCH . RESULTS The diagnosis of PE was established in 69 patients by either high-probability ventilation perfusion scan , pulmonary angiogram , or autopsy . The incidence of PE in group A patients was 4 % ( 48/1,196 ) and in group B was 1.5 % ( 21/1,355 ) . The concomitant use of bilateral PCS and SCH reduced the frequency of postoperative PE in 62 % in comparison to the prophylaxis with SCH alone ( p < 0.001 ) . CONCLUSIONS These data suggest that the combined prophylactic method of bilateral PCS and SCH is superior to SCH alone in the prevention of PE after cardiac surgery OBJECTIVE It has been previously shown that the SCD Response Compression System , by sensing the postcompression refill time of the lower limbs , delivers more compression cycles over time , result ing in as much as a 76 % increase in the total volume of blood expelled per hour . Extended indications for pneumatic compression have necessitated the introduction of portable devices . The aim of our study was to test the hemodynamic effectiveness of a new portable sequential compression system ( the SCD Express ) , which has the ability to detect the individual refill time of the two lower limbs separately . METHODS This was an open , controlled trial with 30 normal volunteers . The new SCD Express was compared with the SCD Response Compression System in the supine and semirecumbent positions . The refilling time sensed by the device was compared with that determined from velocity recordings of the superficial femoral vein using duplex ultrasonography . Baseline and augmented flow velocity and volume flow , including the total volume of blood expelled per hour during compression with the SCD Express , were compared with those produced by the SCD Response compression system in the same volunteers and positions . RESULTS Both devices significantly increased venous flow velocity as much as 2.26 times baseline in supine position and 2.67 times baseline in semirecumbent position ( all P < .001 ) . There was a linear relationship between duplex ultrasonography-derived refill time and the SCD Express-derived refill time in both the supine ( r = 0.39 , P = .03 ) and semirecumbent ( r = 0.71 , P < .001 ) positions but not with the SCD Response . Refill time measured by the SCD Express device was significantly shorter and the cycle rate higher in comparison with the SCD Response in both positions . The single-cycle flow velocity and volume flow parameters generated by the two devices were similar in both positions . However , median ( interquartile range ) total volume of blood expelled per hour was slightly higher with the SCD Express device in the supine position ( 7206 mL/h [ range , 5042 - 8437 ] vs 6712 mL/h [ 4941 - 10,676 ] ; P = .85 ) and semirecumbent position ( 4588 mL/h [ range , 3721 - 6252 ] vs 4262 mL/h [ 3520 - 5831 ] ; P = .22 ) . Peak volume of blood expelled per hour by the SCD Express device in the semirecumbent position was significantly increased by 10 % in comparison with the SCD Response ( P = .03 ) . CONCLUSIONS Flow velocity and volume flow enhancement by the SCD Response and SCD Express were essentially similar . The latter , a portable device with optional battery power that detects the individual refill time of the lower limbs separately , is anticipated to be associated with improved overall compliance and therefore optimized thromboprophylaxis . Studies testing its potential for improved efficacy in preventing deep vein thrombosis are justified Summary . Two hundred and thirty-eight patients with femoral neck fractures were entered into a r and omised pilot study comparing the use of sequential treatment by ‘ Flowtron DVT ’ garments in the perioperative period followed by Enoxaparin ( Clexane-Rhône-Poulenc Rorer ) , and Enoxaparin alone . One hundred and ninety-three patients were excluded indicating the difficulty of achieving pure comparisons in this population . The remaining 44 were r and omised : 21 received Enoxaparin from the time of admission , and 23 had sequential treatment . There was no statistically significant difference in the incidence of thromboembolism . Patient preference did not indicate a favoured treatment subjectively . The operation field was drier in the sequential group , although this did not reach significance . Sequential treatment was not shown to be better or worse than treatment with Enoxaparin , but the trends favoured sequential treatment rather than drug treatment alone . The technique allows the operation to be carried out without the problems produced by low dose heparins and mobilisation is not hindered by compression garments . Résumé . 238 patients présentant une fracture du col du fémur ont fait l’objet d’une étude pour comparer un traitement séquentiel avec utilisation d’une compression intermittente du mollet en période péri-opératoire ( Flowtron DVT ) suivie d’un traitement par Enoxaparin ( Clexane – Rhône Poulenc Rorer ) et un traitement habituel
Output:
| The comparison of compression plus pharmacological prophylaxis versus compression plus aspirin showed a non-significant reduction in PE and DVT in favor of the former group .
Compared with compression alone , combined prophylactic modalities decrease significantly the incidence of venous thromboembolism .
Compared with pharmacological prophylaxis alone , combined modalities reduce significantly the incidence of DVT but the effect on PE is unknown .
The results of the current review support , especially in high-risk patients , the use of combined modalities . |
MS211672 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE In metastatic colorectal cancer , phase III studies have demonstrated the superiority of fluorouracil ( FU ) with leucovorin ( LV ) in combination with irinotecan or oxaliplatin over FU + LV alone . This phase III study investigated two sequences : folinic acid , FU , and irinotecan ( FOLFIRI ) followed by folinic acid , FU , and oxaliplatin ( FOLFOX6 ; arm A ) , and FOLFOX6 followed by FOLFIRI ( arm B ) . PATIENTS AND METHODS Previously untreated patients with assessable disease were r and omly assigned to receive a 2-hour infusion of l-LV 200 mg/m(2 ) or dl-LV 400 mg/m(2 ) followed by a FU bolus 400 mg/m(2 ) and 46-hour infusion 2,400 to 3,000 mg/m(2 ) every 46 hours every 2 weeks , either with irinotecan 180 mg/m(2 ) or with oxaliplatin 100 mg/m(2 ) as a 2-hour infusion on day 1 . At progression , irinotecan was replaced by oxaliplatin ( arm A ) , or oxaliplatin by irinotecan ( arm B ) . RESULT Median survival was 21.5 months in 109 patients allocated to FOLFIRI then FOLFOX6 versus 20.6 months in 111 patients allocated to FOLFOX6 then FOLFIRI ( P = .99 ) . Median second progression-free survival ( PFS ) was 14.2 months in arm A versus 10.9 in arm B ( P = .64 ) . In first-line therapy , FOLFIRI achieved 56 % response rate ( RR ) and 8.5 months median PFS , versus FOLFOX6 which achieved 54 % RR and 8.0 months median PFS ( P = .26 ) . Second-line FOLFIRI achieved 4 % RR and 2.5 months median PFS , versus FOLFOX6 which achieved 15 % RR and 4.2 months PFS . In first-line therapy , National Cancer Institute Common Toxicity Criteria grade 3/4 mucositis , nausea/vomiting , and grade 2 alopecia were more frequent with FOLFIRI , and grade 3/4 neutropenia and neurosensory toxicity were more frequent with FOLFOX6 . CONCLUSION Both sequences achieved a prolonged survival and similar efficacy . The toxicity profiles were different Background : The impact of thymidylate synthase ( TYMS ) and UDP-glucoronosyltransferase 1A ( UGT1A ) germline polymorphisms on the outcome of colorectal cancer ( CRC ) patients treated with irinotecan plus 5-fluorouracil ( irinotecan/5FU ) is still controversial . Our objective was to define a genetic-based algorithm to select patients to be treated with irinotecan/5FU . Methods : Genotyping of TYMS ( 5′TRP and 3′UTR ) , UGT1A1 * 28 , UGT1A9 * 22 and UGT1A7 * 3 was performed in 149 metastatic CRC patients treated with irinotecan/5FU as first-line chemotherapy enrolled in a r and omised phase 3 study . Their association with response , toxicity and survival was investigated by univariate and multivariate statistical analysis . Results : TYMS 3TRP/3TRP genotype was the only independent predictor of tumour response ( OR=5.87 , 95 % confidence interval (CI)=1.68–20.45 ; P=0.005 ) . UGT1A1 * 28/*28 was predictive for haematologic toxicity ( OR=6.27 , 95 % CI=1.09–36.12 ; P=0.04 ) , specifically for neutropenia alone ( OR=6.40 , 95 % CI=1.11–37.03 ; P=0.038 ) or together with diarrhoea ( OR=18.87 , 95 % CI=2.14–166.67 ; P=0.008 ) . UGT1A9 * 1/*1 was associated with non-haematologic toxicity ( OR=2.70 , 95 % CI=1.07–6.82 ; P=0.035 ) . Haplotype VII ( all non-favourable alleles ) was associated with non-haematologic toxicity ( OR=2.11 , 95 % CI=1.12–3.98 ; P=0.02 ) . Conclusion : TYMS and UGT1A polymorphisms influence on tumour response and toxicities derived from irinotecan/5FU treatment in CRC patients . A genetic-based algorithm to optimise treatment individualisation is proposed The aim of this study ( JGOG1063 ) was to determine the recommended dose ( RD ) for combination chemotherapy with irinotecan hydrochloride ( CPT-11 ) and nedaplatin ( NDP ) for advanced cervical squamous cell carcinoma . CPT-11 was given intravenously in fixed doses of 60 mg/m2 on days 1 and 8 and NDP , in escalating doses , on day 1 , every 4 weeks . A total of 15 patients were enrolled in the study . At level 1 ( NDP : 50 mg/m2 ) , one of the 3 patients developed grade 3 diarrhea , so 3 additional patients were enrolled at this level . As none of the 3 additional patients exhibited dose-limiting toxicity , level 1 was elevated to level 2 ( NDP : 60 mg/m2 ) . The maximum tolerated dose was not reached , even at the highest dose level ( level 4 ; NDP : 80 mg/m2 ) . No further dose escalation was carried out , and level 4 ( CPT-11 : 60 mg/m2 , NDP : 80 mg/m2 ) was determined as the RD Purpose To investigate the activity of gemcitabine combined with irinotecan in patients with relapsed small cell lung cancer ( SCLC ) . Patients and methods SCLC patients who had experienced treatment failure with one prior chemotherapy were eligible . Patients were required to have a performance status of 0–2 and adequate organ function . Treatment consisted of gemcitabine ( 1,000 mg/m2 ) and irinotecan ( 150 mg/m2 ) on days 1 and 15 of a 28 day cycle . Results Thirty-one patients were enrolled and 30 patients received protocol treatment ( 10 had refractory disease and 20 had sensitive disease ) . The median age was 64 years , and the median performance status was one . An objective response was obtained in 36.7 % ( 95 % CI : 17.3.1–56.0 % ) of the patients . The median overall survival time was 14.4 months , and the 1 year survival rate was 51 % . The chief grade 3/4 toxicities included neutropenia ( 42 % ) , thrombocytopenia ( 3 % ) , diarrhea ( 9 % ) , and liver dysfunction ( 3 % ) . The only grade 4 toxicities were one case of grade 4 neutropenia ( 3.3 % ) and one case of grade 4 thrombocytopenia ( 3.3 % ) . Conclusion Gemcitabine plus irinotecan is an active regimen that seems to be well-tolerated by patients with previously treated SCLC Background : We investigated the efficacy and safety of biweekly irinotecan and cisplatin ( IP ) as first-line treatment in advanced gastric cancer patients . Methods : Irinotecan 125 mg/m2 on day 1 and cisplatin 60 mg/m2 on day 2 were administrated every 14 days . UGT1A1 * 28/*6 and toxicities were analyzed . Results : Forty-one eligible patients were enrolled . Fifteen patients , who were defined as the high-dose group , received starting doses of irinotecan 125 mg/m2 . Twenty-six patients , who were defined as the low-dose group , received starting doses of irinotecan 80 mg/m2 and cisplatin 50 mg/m2 . The response rate was 53.3 % in the irinotecan high-dose group and 53.8 % in the irinotecan low-dose group . The most common grade 3/4 toxicity was neutropenia ( 68.3 % ) . No significant difference in grade 3/4 neutropenia was found between patients with the wild-type genotype and those with variant genotypes for UGT1A1 * 28 or UGT1A1 * 6 . Conclusions : The combination of biweekly irinotecan 80 mg/m2 and cisplatin 50 mg/m2 was active and tolerable . The role of the UGT1A1 genotype in clinical toxicity of an IP regimen requires further investigation Background : To assess the efficacy and safety of individualised dose optimisation of irinotecan monotherapy as salvage treatment for advanced gastric cancer ( AGC ) . Methods : A total of 43 patients were enrolled . Intravenous irinotecan ( 350 mg m−2 ) was administered every 3 weeks . The dose was increased ( 425 mg m−2 and 500 mg m−2 ) or decreased ( 250 mg m−2 ) depending on patient tolerance . UGT1A1 genotypes were determined by direct sequencing of genomic DNA extracted from peripheral blood . Results : A total of 183 cycles of irinotecan were administered , with a median of four cycles per patient . The overall response rate was 9.3 % , and the disease control rate was 62.8 % . Median time to disease progression was 2.8 months , and median overall survival was 8.0 months . Grade 3–4 neutropenia was the most common toxicity ( 53.5 % ) , and febrile neutropenia was the least common toxicity ( 4.6 % ) . Compared with defective allele groups , UGT1A1 * 1/*1 was associated with a lower incidence of grade 3–4 neutropenia during the first cycle ( P=0.018 ) . Conclusion : Individualised irinotecan dose escalation based on patient tolerance was not associated with increased toxicity and shows modest activity as salvage chemotherapy for AGC . The role of UGT1A1 genotype in clinical toxicity requires further evaluation Irinotecan‐induced severe neutropenia is associated with homozygosity for the UGT1A1 * 28 or UGT1A1 * 6 alleles . In this study , we determined the maximum‐tolerated dose ( MTD ) of irinotecan in patients with UGT1A1 polymorphisms . Patients who had received chemotherapy other than irinotecan for metastatic gastrointestinal cancer were enrolled . Patients were divided into three groups according to UGT1A1 genotypes : wild‐type ( * 1/*1 ) ; heterozygous ( * 28/*1 , * 6/*1 ) ; or homozygous ( * 28/*28 , * 6/*6 , * 28/*6 ) . Irinotecan was given every 2 weeks for two cycles . The wild‐type group received a fixed dose of irinotecan ( 150 mg/m2 ) to serve as a reference . The MTD was guided from 75 to 150 mg/m2 by the continual re assessment method in the heterozygous and homozygous groups . Dose‐limiting toxicity ( DLT ) and pharmacokinetics were evaluated during cycle 1 . Of 82 patients enrolled , DLT was assessable in 79 patients ( wild‐type , 40 ; heterozygous , 20 ; and homozygous , 19 ) . Dose‐limiting toxicity occurred in one patient in the wild‐type group , none in the heterozygous group , and six patients ( grade 4 neutropenia ) in the homozygous group . In the homozygous group , the MTD was 150 mg/m2 and the probability of DLT was 37.4 % . The second cycle was delayed because of neutropenia in 56.3 % of the patients given the MTD . The AUC0–24 h of SN‐38 was significantly greater ( P < 0.001 ) and more widely distributed in the homozygous group . Patients homozygous for the UGT1A1 * 28 or UGT1A1 * 6 allele can receive irinotecan in a starting dose of 150 mg/m2 , but many required dose reductions or delayed treatment in subsequent cycles . UMIN Clinical Trial Registration number : UMIN000000618 . ( Cancer Sci 2011 ; 102 : 1868–1873 Introduction : Paclitaxel plus carboplatin ( TC ) is generally considered to be the " gold st and ard " regimen for treatment of epithelial ovarian carcinomas . Little data are available , however , on the use of this regimen in patients with clear cell adenocarcinoma of the ovary ( CCC ) . Combination chemotherapy with irinotecan hydrochloride plus cisplatin has been reported to be effective for primary and recurrent or resistant CCC . We compared these 2 combinations in patients with CCC . Methods : Patients (
Output:
| In conclusion , in this meta- analysis , the UGT1A1 * 6 polymorphisms were associated with an increased risk of IRI-induced neutropenia in cancer patients , and increased incidences of severe neutropenia could be correlated with diverse regions , cancer type , low dose of IRI and the duration of treatment |
MS211673 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Aims : To estimate the impact of school fruit tuck shops on children ’s consumption of fruit and sweet and savoury snacks . Design : Cluster r and omised effectiveness trial with school as the unit of r and omisation . Setting : 43 primary schools in deprived areas in south Wales and south-west Engl and with a range of school food policies . Intervention : Schools operated fruit tuck shops throughout one academic year . Control schools did not do so . Measures : Repeated cross-sections of children aged 9–11 years completed a computerised 24-hour recall question naire at baseline ( n = 1902 ) and at 1-year follow-up ( n = 1924 ) , when a brief question naire was also completed ( n = 1976 ) . Results : Approximately 70 000 fruits were sold in the 23 intervention schools over the year , equivalent to 0.06 fruits per student per day . Children in intervention schools were more likely to report eating fruit as a snack at school ‘ often ’ ( OR 1.49 , 95 % CI 1.15 to 1.95 ) . There were no significant differences in children ’s intake of fruit or other snacks . There was a significant interaction ( p<0.02 ) between the intervention group and school food policy : where students were only allowed to bring fruit to school , fruit consumption was 0.37 portions per day ( 0.11 to 0.64 ) higher in intervention schools , compared to 0.14 portions ( −0.30 to 0.58 ) where no food was allowed and −0.13 portions ( −0.33 to 0.07 ) where there were no restrictions . Conclusions : In isolation , fruit tuck shops were not effective in changing children ’s snacking behaviour in schools . However , the results suggest that fruit tuck shops had a greater impact when reinforced by school policies restricting the types of foods students were allowed to bring to school OBJECTIVE . The study tested whether a combined environmental and educational intervention solely promoting water consumption was effective in preventing overweight among children in elementary school . METHODS . The participants in this r and omized , controlled cluster trial were second- and third- grade rs from 32 elementary schools in socially deprived areas of 2 German cities . Water fountains were installed and teachers presented 4 prepared classroom lessons in the intervention group schools ( N = 17 ) to promote water consumption . Control group schools ( N = 15 ) did not receive any intervention . The prevalence of overweight ( defined according to the International Obesity Task Force criteria ) , BMI SD scores , and beverage consumption ( in glasses per day ; 1 glass was defined as 200 mL ) self-reported in 24-hour recall question naires , were determined before ( baseline ) and after the intervention . In addition , the water flow of the fountains was measured during the intervention period of 1 school year ( August 2006 to June 2007 ) . RESULTS . Data on 2950 children ( intervention group : N = 1641 ; control group : N = 1309 ; age , mean ± SD : 8.3 ± 0.7 years ) were analyzed . After the intervention , the risk of overweight was reduced by 31 % in the intervention group , compared with the control group , with adjustment for baseline prevalence of overweight and clustering according to school . Changes in BMI SD scores did not differ between the intervention group and the control group . Water consumption after the intervention was 1.1 glasses per day greater in the intervention group . No intervention effect on juice and soft drink consumption was found . Daily water flow of the fountains indicated lasting use during the entire intervention period , but to varying extent . CONCLUSION . Our environmental and educational , school-based intervention proved to be effective in the prevention of overweight among children in elementary school , even in a population from socially deprived areas This study reports the effect of the Fruits and Vegetables Make the Marks intervention , a school-based fruit and vegetable intervention consisting of a home economics classroom component and parental involvement and encouraged participation in the Norwegian School Fruit Programme , all delivered during the school year of 2001 - 02 . Nine r and omly chosen schools received the intervention and 10 schools served as control schools . Participating pupils completed question naires at baseline ( September 2001 ) , at Follow-up 1 ( May-June 2002 ) and at Follow-up 2 ( May 2003 ) . A total of 369 pupils ( 69 % ; mean age , 11.3 years at baseline ) participated in all three surveys . No effect of the intervention was found for intake of fruit and vegetables eaten at school or all day , neither at Follow-up 1 nor at Follow-up 2 . On analysing the effects on potential mediators , significant differences between intervention and control groups were found for Awareness of the five-a-day recommendations only . The intervention programme was rated as very good by the teachers , and the pupils reported that they enjoyed it . However , the intervention failed to change fruit and vegetable intake , probably because it did not succeed in changing the pupils ' preferences for or the accessibility of fruit and vegetables -- the two strongest correlates of children 's fruit and vegetable intake OBJECTIVE To assess the impact of a school-based nutrition education intervention aim ed at increasing the consumption of fruits and vegetables . DESIGN The intervention programme increased the provision of fruits and vegetables in schools and provided a range of point-of-purchase marketing material s , newsletters for children and parents , and teacher information . Curriculum material s at age 6 - 7 and 10 - 11 years were also developed and utilised . Evaluation was undertaken with groups of younger ( aged 6 - 7 years ) and older ( aged 10 - 11 years ) children . Methods included 3-day dietary records with interview and cognitive and attitudinal measures at baseline , with follow-up at 9 months , in intervention and control schools . SETTING The work was undertaken in primary schools in Dundee , Scotl and . SUBJECTS Subjects comprised 511 children in two intervention schools with a further 464 children from two schools acting as controls . RESULTS Children ( n=64 ) in the intervention schools had an average increase in fruit intake ( 133+/-1.9 to 183+/-17.0 g day(-1 ) ) that was significantly ( P<0.05 ) greater than the increase ( 100+/-11.7 to 107+/-14.2 g day(-1 ) ) estimated in children ( n=65 ) in control schools . No other changes in food or nutrient intake were detected . Increases in scores for variables relating to knowledge about fruits and vegetables and subjective norms were also greater in the intervention than in the control group , although taste preferences for fruits and vegetables were unchanged . CONCLUSIONS It is concluded that a whole school approach to increasing intakes of fruits and vegetables has a modest but significant effect on cognitive and attitudinal variables and on fruit intake OBJECTIVE To study whether service of a free school lunch has an impact on weight development and food intake among pupils at a lower secondary school , and to assess the association between self-perceived school behaviour and food intake . DESIGN A controlled intervention study involving service of a free healthy school lunch to 9th grade pupils took place over 4 months , from January to May 2007 . Weight and height were measured before and after the intervention . The pupils also completed a short FFQ and a question naire concerning self-perceived school behaviour and the classroom environment before and after the intervention . A healthy food score was calculated using the FFQ data . SETTING All 9th grade rs at three different lower secondary schools in southern Norway were invited to participate . One school was r and omly selected as the intervention school . SUBJECTS Fifty-eight pupils ( 91 % ) from the intervention school and ninety-two pupils ( 77 % ) from the control schools participated . RESULTS BMI did not increase among the girls at the intervention school , but increased significantly among the boys at the intervention school and among the control school groups . The healthy food score correlated positively with the trait ' satisfied with schoolwork ' ( P < 0.001 ) . Fifteen per cent of the variance in food score could be explained by gender and the trait ' satisfied with schoolwork ' . CONCLUSIONS Serving of a healthy free school lunch to secondary -school pupils may result in restricted weight gain . Further studies are needed to clarify the impact of school meals on overweight and academic performance BACKGROUND This study evaluated the effects of a school-based dietary intervention program to increase fruit and vegetable consumption among fourth- grade rs . METHODS Twenty-eight elementary schools were r and omized to an immediate intervention condition or to a delayed intervention control condition . Measures of diet and psychosocial variables were collected at base line and 1 and 2 years post-baseline . The intervention included classroom , parent , and cafeteria components . RESULTS Mean daily consumption of fruit and vegetables was higher for the intervention children compared with controls at Follow-up 1 ( X(t ) = 3.96 , X(c ) = 2.28 ) and at Follow-up 2 ( X(t ) = 3.20 , X(c ) = 2.21 ) . Macro- and micronutrient changes favoring the intervention children were also observed at both Follow-up 1 and Follow-up 2 . Mean daily consumption of fruit and vegetables was higher for intervention parents compared with controls at Follow-up 1 ( X(t ) = 4.23,X(c ) = 3.94 ) but not at Follow-up 2 . CONCLUSIONS Strong effects were found for the High 5 intervention on fruit and vegetable consumption , on macro- and micro-nutrients , and on psychosocial variables . Future work is needed to enhance the intervention effects on parents ' consumption and to test the effectiveness of the intervention when delivered by classroom teachers This article reports on the outcomes of the Teens Eating for Energy and Nutrition at School ( TEENS ) study , a 2-year intervention study conducted in 16 middle schools with a goal of increasing students ’ intakes of fruits , vegetables , and lower fat foods . Despite positive interim results for students r and omized to intervention schools , the positive effects of the intervention were not seen for the primary outcomes at the end of the 2nd year . Positive effects were seen only for a food choice score ( suggesting that the students usually choose lower versus higher fat foods ) and not for measures of food intake . Future studies may need to take a step back toward more controlled efficacy studies in working with this age-group . In addition , future work may consider the use of peer leaders , more intensive teacher training , ongoing formative assessment , and the testing of more powerful environmental change intervention strategies OBJECTIVE To determine the uptake of a free fruit provision to low-decile primary -school children by quantitatively assessing changes in fruit intake . DESIGN A r and omised controlled trial using a paired , cluster r and omisation . SETTING Twenty low-decile primary schools ( schools attended by the most deprived children ) in Auckl and , New Zeal and . SUBJECTS In total 2032 children , aged 7 - 11 years , provided data on at least one occasion . INTERVENTION Ten pairs of low-decile primary schools matched by roll size and location were r and omly allocated to control ( no free fruit ) or intervention ( free fruit ) for a school term . Dietary assessment s using the 24 h recall methodology were made at baseline , on the last week of the intervention and 6 weeks post-intervention . RESULTS Fruit intakes in this cohort were lower than the national average with over 40 % reporting no fruit intake at baseline and did not differ between groups . After the free fruit period the intervention group increased school fruit intakes by 0.39 pieces/school d from baseline ( P < or = 0.001 ) and the proportion of children consuming no fruit reduced to 22 % . This increase , however , was not sustained and fruit intakes fell below baseline levels at 6 weeks post-intervention . Control subjects did not significantly alter their fruit intakes throughout the study . CONCLUSIONS Improving exposure and accessibility to fruits at school increases fruit intakes of low socio-economic group children , particularly those who do not normally eat fruit . The present pilot study demonstrates some possible negative effects of short-term free fruit interventions , but is informative for developing and evaluating sustained fruit intervention programmes OBJECTIVES A r and omized school based trial sought to increase fruit and vegetable consumption among children using a multicomponent approach . METHODS The intervention , conducted in 20 elementary schools in St. Paul , targeted a multiethnic group of children who were in the fourth grade in spring 1995 and the fifth grade in fall 1995 . The intervention consisted of behavioral curricula in classrooms , parental involvement , school food service changes , and industry support and involvement . Lunchroom observations and 24-hour food recalls measured food consumption . Parent telephone surveys and a health behavior question naire measured psychosocial factors . RESULTS The intervention increased lunchtime fruit consumption and combined fruit and vegetable consumption , lunchtime vegetable consumption among girls , and daily fruit consumption as well as the proportion of total daily calories attributable to fruits and vegetables . CONCLUSIONS Multicomponent school-based programs can increase fruit and vegetable consumption among children . Greater involvement of parents and more attention to increasing vegetable consumption , especially among boys , remain challenges in future intervention research Background / Objectives : Previous research in the United Kingdom , where there is a school canteen system , has shown that the Food Dudes intervention substantially increases children 's fruit and vegetable consumption . The current study evaluated its effectiveness in Irel and where school meals are not provided and children bring food to school in lunchboxes . Subjects/ Methods : Participants were 4- to 11-year-old children attending two primary schools ; the schools were r and omly assigned to experimental or control conditions ( n=228 and 207 , respectively ) . During the 16-day intervention in the experimental school , children watched video adventures featuring the heroic Food Dudes , and received small rewards for eating fruit and veget
Output:
| Characteristics of the interventions that demonstrated effectiveness are : duration > 1 year , introduction into the regular activities of the school , parental involvement , introduction of nutrition education into the regular curriculum , and provision of fruits and vegetables by school food services .
CONCLUSION Interventions in schools to reduce overweight and obesity , as well as to increase fruits and vegetable consumption , have demonstrated effectiveness in the best-conducted studies |
MS211674 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The purpose of our study is to estimate the effect of tourniquet release and cementing in perioperative blood loss associated with total knee arthroplasty . Eighty patients were r and omly allocated into two equal groups concerning the timing of tourniquet release . Group A : patients with tourniquet release and haemostasis before wound closure and group B : patients with tourniquet release after skin closure and compressive b and aging . These groups were further subdivided in two subgroups ( + and - ) depending on cementing or not of the tibial tray only . The total blood loss averaged 961 ml in group A and 692 ml in group B , while it was estimated 763 ml in the cemented group and 890 ml in the non-cemented group . The total blood loss within subgroups was Group A+ 904 ml , Group A- 1017 ml , Group B+ 622 ml and Group B- 762 ml . The mean number of blood units transfused per patient was 4.7 in Group A and 4.0 in Group B , while the mean operating time was 79 min and 66 min , respectively . Complications such as deep vein thrombosis , haematomata and minor wound complications occurred in patients of Group A and Group B , 0 and 2 , 0 and 2 , 8 and 11 , respectively . Intraoperative tourniquet release seems to be related with significantly greater blood loss ( P<0.001 ) and dem and s in blood transfusion P<0.05 as well as a longer operating time ( P<0.001 ) . Cementing of total knee replacements has a better haemostatic role compared to non-cemented prosthesis ( P<0.05 ) . Even though complications were more in postoperative tourniquet release group , no statistically significant difference was found between group A and B. Postoperative tourniquet release seems to offer better conditions of haemostasis probably due to the better controlled fibrolytic activity BACKGROUND Total knee arthroplasty ( TKA ) is commonly performed using a tourniquet . However , some studies have reported that several complications were associated with the use of a tourniquet in TKA . In this study we investigate whether the limited use of a tourniquet in TKA would reduce complications and facilitate postoperative recovery . METHODS Sixty patients were r and omly divided into two groups ( 30 cases/group ) : group A using the tourniquet throughout the surgical procedure , and group B using the tourniquet starting from the cementation to the completion of the procedure . Operation time , total measured blood loss , and incidence of complications were all recorded . RESULTS There was no significant difference in operation time , total measured blood loss , and hemoglobin concentration between the two groups . Incidence of postoperative complications in group B was significantly decreased in comparison to that in group A. The limb circumference at 10 cm above the superior patellar pole or below the inferior patellar pole and the pain score in group B were significantly decreased compared with that in group A at any time point . Range of motion in group B was significantly increased at three and 5 days postoperatively in comparison to that in group A. CONCLUSIONS The limited use of a tourniquet in TKA provides the benefit of decreased limb swelling and knee joint pain while not compromising the operation time or blood loss and recovery . LEVEL OF EVIDENCE Level I ( Therapeutic ) . TRIAL REGISTRATION NUMBER NCT02102581 In surgical practice , hemostasis is used to minimize postoperative bleeding in total knee arthroplasty . We performed a prospect i ve r and omized study to determine the influence of tourniquet use and the timing of its release on amount of bleeding . Eighty four patients ( 96 knees ) were scheduled for total knee arthroplasty and r and omly divided into three groups . Posterior cruciate retaining bicompartmental total knee prostheses were used in all . In group I , no tourniquet was used . In group II , a tourniquet was used and was deflated for hemostasis once all components had been inserted . In group III , the tourniquet was deflated after wound closure and application of a compressive dressing . Mean blood drainage , mean volume of blood transfusion , hemoglobin ( Hb ) and hematocrit ( Hct ) values and operative time were compared between the three groups . Mean blood drainage was 810 mL ( 300 - 1300 ) in groups I 720 mL ( 240 - 1200 ) in group II and 705 mL ( 250 - 1150 ) in group III ( p = 0.062 ) . The Hb and Hct values , tourniquet time ( for groups II and III ) and volume of blood transfusion were similar . The operative time was significantly longer for first group ( p = 0.012 ) . Using tourniquet and its intraoperative release with hemostasis , does not reduce blood loss in total knee arthroplasty , but using tourniquet reduces operation time significantly Background Total knee arthroplasty with the use of a tourniquet during the entire operation has not been shown to improve the performance of the operation and may increase the risk of complications . Questions / purpose sWe asked whether the limited use of a tourniquet for cementation only would affect ( 1 ) surgical time ; ( 2 ) postoperative pain and motion of the knee ; ( 3 ) blood loss ; or ( 4 ) complications such as risk of nerve injuries , quadriceps dysfunction , and drainage compared with use of a tourniquet throughout the procedure . Methods Seventy-one patients ( 79 knees ) were r and omized to either use of a tourniquet from the incision through cementation of the implants and deflated for closure ( operative tourniquet group ) or tourniquet use only during cementation ( cementation tourniquet group ) . The initial study population was a minimum of 30 knees in each group as suggested for r and omized studies by American Society for Testing and Material s st and ards ; termination of the study was determined by power analysis performed after 40 knees in each group showed any statistical solution to our questions would require a minimum of 260 more cases . Patients were excluded who were considered in previous r and omized studies as high risk for complications , which might be attributed to the tourniquet . Results There were no differences in terms of surgical time , pain scores , pain medicine requirements , range of motion , hemoglobin change , or total blood loss . One major complication ( compartmental syndrome ) occurred in a patient with tourniquet inflation until closure . No other complications were attributed to the use of a tourniquet . Conclusions With the numbers available , our results suggest that there are no important clinical differences between patients who had a tourniquet inflated throughout the procedure compared with those who had it inflated only during cementation . Tourniquet inflation for cementation only provides the benefit of bloodless bone for fixation and may eliminate the risks associated with prolonged tourniquet use . Level of Evidence Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence Background Blood management is critical in total knee arthroplasty ( TKA ) . In bilateral , single stage TKA , blood loss seems more prominent . We believe it is important to control all potential bleeding within the wound tissue . Purpose The purpose of the study was to evaluate a series of topical procedures used to reduce blood loss and transfusion in single-stage bilateral cemented total knee arthroplasty : antifibrinolysis with tranexamic acid , vasoconstriction with epinephrine , sealing of the bone section intraoperatively , and closure of the drainage tube within the first 4 h postoperatively . Material s and methods Patients with osteoarthritis of the knees were r and omly divided into two groups . In group A , 5 ml ( 25 mg/ml ) tranexamic acid ( TXA ) and 5 ml analgesic containing epinephrine ( 3 μg/ml ) solution were injected at several points into the posterior capsule before installation of the prosthesis . The femoral medullar canal was closed with autograft bone and then sealed compressively with cement . Before the tourniquet was released , 10 ml TXA solution and 10 ml analgesic containing epinephrine were injected at several points into the periosteum , synovium , joint capsule , tendons , and deep fascia tissue ( injection of analgesic containing epinephrine into subcutaneous fat and dermis was avoided ) . The residual nail holes in the bone and the uncovered bone section were covered with bone wax . The tourniquet was then removed , and active bleeding points were stanched . TXA solution ( 20 ml ) was injected into the articular cavity after wound closure . The drainage tube was clamped for 4 h , then opened . In group B , injection of analgesic containing epinephrine into soft tissue , control of active bleeding , and clamping of the drainage tube for 4-h , only , were performed . Results Ninety patients were enrolled in the study . Compared with those in group B , intraoperative blood loss , drainage volume , total postoperative blood loss , and number of patients requiring allogenic blood transfusion were significantly reduced in group A. There was no significant difference between the incidence of complications in the groups . Conclusions Our topical procedures enable effective and safe reduction of blood loss and the number of patients requiring transfusion in single-stage bilateral osteoarthritic TKA Purpose Pneumatic tourniquets are frequently used in knee arthroplasty surgery . However , there is a lack of evidence to define safe tourniquet time in lower limb surgery . The primary aim of this study was to investigate whether tourniquet time influences the risk of postoperative complications after primary and secondary knee arthroplasty . Methods This study was a prospect i ve register study . Since we wanted dispersion in tourniquet time , we included a consecutive series of 577 primary knee arthroplasties , 46 revision knee arthroplasties , and 18 patellar supplementing knee arthroplasties from a clinical audit data base over a period of five years . The following postoperative complications were recorded : superficial wound infections , deep wound infections , deep vein thrombosis , pulmonary embolism , nerve injuries , compartment syndrome , cuff pressure injuries , and b and age injuries . Results Tourniquet time over 100 minutes was associated with an increased risk of complications after knee arthroplasty surgery ( OR 2.2 , CI 1.5–3.1 ) . This increase in risk remained after adjusting for cuff pressure , sex , age , American Society of Anesthesiologists ( ASA ) classification , smoking , diabetes , and surgery indication ( OR 2.4 , CI 1.6–3.6 ) . Conclusions Tourniquet time over 100 minutes increases the risk of complications after knee arthroplasty surgery and special attention is advocated to reduce the tourniquet time AIM To reduce blood loss in total knee arthroplasty various physical measures including the use of a tourniquet are recommended . The question of an early tourniquet release is still unsettled . PATIENTS AND METHOD To confirm our theory that blood loss and need of blood transfusions might be reduced while removing the tourniquet for meticulous hemostasis before wound closure we analysed 70 ( 41 male , 29 female ) consecutive patients with total knee arthroplasty for osteoarthritis performed by a single surgeon in a prospect ive-r and omized study between 1/1996 to 6/1998 . In group I the tourniquet was released before , in group II after wound closure . RESULTS We could n't find any significant differences in the estimated blood loss , the decrease of hemoglobin and hematocrit level , and the transfusion need . In Group II we observed two cases of deep vein thrombosis . This difference was not significant . CONCLUSION We conclude that tourniquet release for hemostasis is not an effective tool in reducing blood loss or transfusion need in total knee arthroplasty Today the use of pneumatic tourniquet is commonly accepted in total knee arthroplasty ( TKA ) to reduce perioperative blood loss . There are a few prospect i ve r and omised and nonr and omised studies that compare the effect of tourniquet release timing in cementless or cemented unilateral TKA . However , many of these studies show an inadequate reporting and methodology . This r and omized prospect i ve study was design ed to investigate the efficiency of tourniquet release timing in preventing perioperative blood loss in a simultaneous bilateral TKA study design . To our knowledge , this is the first study of its kind , in which the effect of tourniquet release timing on perioperative blood loss was investigated in simultaneous bilateral cemented TKA to compare both techniques intraindividually . In 20 patients ( 40 knees ) one knee was operated with tourniquet release and hemostasis before wound closure , and the other knee with tourniquet release after wound closure and pressure dressing . We found no significant difference in total blood loss between both techniques ( p=0.930 ) , but a significant difference in operating time ( p=0.035 ) . There were no postoperative complications at a follow-up of 6 month . Other studies report an increase the blood loss in early tourniquet release and an increase the risk of early postoperative complications in deflation of tourniquet after wound closure . In this study we found no significant difference in perioperative blood loss and no increase of postoperative complications . Therefore , we recommend a tourniquet release after wound closure to reduce the duration of TKA procedure and to avoid possible risks of extended anaesthesia We included 46 total knee arthroplasties ( 43 patients ) in a prospect i ve , r and omised study , dividing them into two groups : group A ( 23 knees , 21 patients ) in which the ischaemia was released prior to wound
Output:
| The results showed that there were no significant differences in overt blood loss , hemoglobin drop , and blood transfusions , whereas the tourniquet release after wound closure might increase the risks of overall complications and major complications .
Conclusions Tourniquet release before wound closure for hemostasis might reduce the rate of complications , but it could not limit overall blood loss .
The current evidence s are not enough to indicate that tourniquet release before wound closure is superior to its release after wound closure in cemented TKA |
MS211675 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE Damage to the inferior alveolar nerve when extracting lower third molars is often caused by the intimate relationship between the nerve and the roots of the teeth . The technique of coronectomy , or intentional root retention , may minimize this problem . PATIENTS AND METHODS Forty-one patients underwent coronectomy on 50 lower third molars with follow-up of at least 6 months . The technique of coronectomy deliberately protected the lingual nerve as part of the surgical procedure . All roots were left at least 3 mm below the buccal and lingual plates of bone . All patients were radiographed preoperatively , immediately postoperatively , and after 6 months . RESULTS There were no cases of inferior alveolar nerve-involved damage in this study of 41 patients who underwent 50 coronectomies . There was 1 case of transient lingual nerve involvement , probably from the use of the lingual retractor . One patient required subsequent removal of the roots of both lower third molars because of failure to heal , and 1 patient required subsequent removal of a root because of subsequent migration to the surface . Root migration was noted in approximately 30 % of patients over a 6 month period . CONCLUSION Coronectomy appears to be a viable technique in those cases where removal of the whole tooth might put the inferior alveolar nerve at considerable risk of damage . The technique appears to be associated with a low incidence of complications , but subsequent migration of the roots may be an issue in the long term PURPOSE Studies have suggested that coronectomy reduces the risk of inferior alveolar nerve injury ( IANI ) when a close relationship with the inferior alveolar canal is indicated on panoramic imaging . However , the relationship between the inferior alveolar canal and the root are unclear on panoramic imaging . Our aim was to compare coronectomy with traditional extraction for the treatment of m and ibular third molars that had clear high IANI risks as evaluated by dental computed tomography . PATIENTS AND METHODS We design ed a case-control study of subjects with high-risk signs of IANI on panoramic images evaluated by dental computed tomography before enrollment . The 220 patients enrolled were assigned to extraction ( control group , n = 118 ) or coronectomy ( case group , n = 102 ) . RESULTS The mean follow-up time was 13 months in the extraction group and 13.5 months in the coronectomy group . Six IANIs ( 5 % ) were found in the extraction group . In the coronectomy group , 1 patient ( 1 % ) had symptoms of neurapraxia , which disappeared within 1 month . Four remaining roots had signs of postoperative infection , and the patients underwent extraction of the root . No nerve damage result ed in these patients after repeat extraction . CONCLUSIONS Coronectomy might reduce the risk of nerve injury for patients at true high risk of IANI as evaluated by dental computed tomography . A long-term postoperative review is needed to assess the incidence of root migration and the root extraction and infection rates after coronectomy PURPOSE There is no long-term evaluation on the safety of coronectomy of the lower third molar . The aim of this study was to investigate the 3-year morbidity of coronectomy of the lower third molars and to monitor the behavior and migration pattern of the retained roots after coronectomy . MATERIAL S AND METHODS This was a prospect i ve cohort study . Patients with lower third molars with specific radiographic sign(s ) showing proximity of the roots to the inferior alveolar nerve who underwent coronectomy in a previous r and omized clinical trial were review ed postoperatively in the first week and the third , sixth , 12th , 24th , and 36th months . The morbidities of infection , pain , root eruption , reoperation to remove the root , and the development of any pathology were recorded . The pattern of any root migration was analyzed . RESULTS Ninety-eight patients ( 35 men and 63 women ; mean age , 25.7 yrs ; st and ard deviation , 7.9 yrs ) with 135 coronectomies completed the 36-month review . None presented with infection or pain from the postoperative third month onward . Root eruption causing sensitivity occurred in 3 % ( 4/135 ) of the sample and the erupted roots were removed . None of the reoperated cases presented with a postoperative inferior alveolar nerve deficit . No pathology developed in any of the retained roots after coronectomy . Root migration was noted in most cases in the first 12 months , and all roots stopped migrating from the 24th month onward . The mean root migration at 36 months was 2.8 mm ( st and ard deviation , 1.4 mm ) . CONCLUSIONS This study confirms that retained roots after coronectomy in the lower third molars produce no complications in terms of infection , pain , or the development of pathologies within the first 3 years . Root eruption can occur in a very small percentage of patients and may require reoperation to remove the root OBJECTIVE The objective of this study was to compare the surgical complications and neurosensory disturbances of coronectomy and total excision of lower wisdom teeth with roots in close proximity to the inferior dental nerve ( IDN ) . STUDY DESIGN A r and omized controlled trial was conducted to compare the surgical complications and IDN deficit of coronectomy and total removal of wisdom teeth . Patients with specific radiographic signs of close proximity of wisdom teeth roots to the IDN were r and omized . RESULTS A total of 231 patients underwent surgery for 349 lower wisdom teeth ( 171 coronectomies , 178 controls ) ; 16 coronectomies failed and were removed in total . Nine patients in the control group presented with IDN deficit , compared with 1 in coronectomy group ( P = .023 ) . Pain and dry socket incidence was significantly lower in the coronectomy group , and there were no statistical differences in infection rate between the 2 groups . Reoperation of one coronectomy case was performed owing to persistent root exposure . CONCLUSION There are fewer complications in terms of IDN deficit , pain , and dry socket after coronectomy , but the infection rate is similar to that of total excision We r and omised 128 patients who required operations on m and ibular third molars and who had radiological evidence of proximity of the third molar to the canal of the inferior alveolar nerve to one of two operations : extraction [ n=102 ] , and coronectomy [ n=94 ] . Some roots were dislodged during intended coronectomy and were therefore removed , result ing in two subgroups ( successful coronectomy n=58 , and failed coronectomy n=36 ) . The mean ( S.D. ) follow up was 25 ( 13 ) months . Nineteen nerves were damaged ( 19 % ) after extraction , none after successful coronectomy , and three ( 8 % ) after failed coronectomy ( p=0.01 ) . The incidence of dry socket infection was similar in the three groups ( 10/102 , 10 % , 7/58 , 12 % , and 4/36 , 11 % , respectively ) . No root required removal or reoperation . To our knowledge this is the first clinical trial of the efficacy of coronectomy in preserving the inferior alveolar nerve . The length of follow up was about 2 years , which for the assessment of delayed eruption of the root fragments is not sufficient as this process may continue for up to 10 years . However , it seems that coronectomy reduces the incidence of injury to the inferior alveolar nerve without increasing the risk of dry socket or infection Coronectomy involves removal of a crown from roots of a healthy tooth in healthy patients indicated to prevent inferior alveolar nerve injury in a high risk case . Since the original paper in 2005 ( 2005 ; 43 : 7–12 ) describing a prospect i ve r and omised study on coronectomy , there has been a lot of interest in this procedure and it has become routine practice in many oral surgery departments within the UK and USA . A significant variance in thresholds for prescribing coronectomy and also for the technique of its delivery has been highlighted by a recent review . This has result ed in frequent queries about the technique and which patients may be suitable . Thus this paper aims to highlight some finer points of the coronectomy technique and how to avoid potential pitfalls PURPOSE Close proximity of the inferior alveolar nerve ( IAN ) to the third molar roots can result in nerve injuries during extraction of third molars . Consequently , it is necessary to determine the relationship of the nerve and roots to avoid damage to the IAN . Computed tomography scans are widely used to determine the correct relationship between the IAN and lower third molars . PATIENTS AND METHODS The study consisted of 10 patients with 16 lower third molars in close relationship with the IAN who were divided into a study group and a control group . The patients in the study group were treated via coronectomies performed with endodontic treatments . The patients in the control group underwent coronectomies without endodontic treatment . The patients were followed up for at least 1 year . RESULTS We had to extract 7 of the roots because of the infection in 8 patients belonging to the study group , which were treated endodontically . Moreover , there were 3 cases of IAN damage because of the extraction in the study group . However , in the control group , no infection was determined and IAN damage was absent . CONCLUSION Coronectomy appears to be a reliable technique to protect the IAN from damage . This procedure has a low incidence of complications . Endodontic treatment does not affect the success of this method according to our results
Output:
| RESULTS The following articles were obtained which represents a total of 17 : 1 systematic review , 2 r and omized clinical trials and 2 non-r and omized clinical trials , 3 cohort studies , 2 retrospective studies , 3 case studies and 4 literature review s. CONCLUSIONS Coronectomy is an adequate preventative technique in protecting the inferior alveolar nerve , which is an alternative to the conventional extraction of third molars , which unlike the former technique , presents a high risk of injury to the inferior alveolar nerve . |
MS211676 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: In spite of the high prevalence of tuberculosis worldwide , there are few studies on its psychiatric complications . The mental state of 53 patients with pulmonary tuberculosis seen in a Nigerian chest clinic was examined using the 30-item General Health Question naire ( GHQ-30 ) , the Present State Examination ( PSE ) , and a clinical evaluation based on the International Classification of Disease , tenth edition ( ICD-10 ) . Results were compared with two comparison groups : ( 1 ) a group of 20 long-stay orthopedic patients with lower limb fractures ; and ( 2 ) a group of 20 apparently healthy controls . The sociodemographic characteristics of the groups were also compared . A significantly higher prevalence of psychiatric disorders was found in the tuberculosis group ( 30.2 % ) than in the orthopedic group ( 15 % ) and the apparently healthy controls ( 5 % ) . The types of psychiatric disorders encountered included mild depressive episode , generalized anxiety disorder , and adjustment disorder ( ICD-10 ) . Psychiatric morbidity was higher in tuberculosis patients with low educational attainment , and did not show a statistically significant relationship with other sociodemographic parameters . Ways of improving the mental health of tuberculosis patients are discussed BACKGROUND AND OBJECTIVE The objective of this study was to develop a specific instrument for measuring health-related quality of life ( HRQL ) in patients receiving home mechanical ventilation ( HMV ) . METHODS The Severe Respiratory Insufficiency ( SRI ) Question naire was developed and tested for its psychometric properties following a multicentric clinical trial including 226 patients receiving HMV ( mean age 57.3+/-14.0 years ) . RESULTS Forty-nine items passed the selection process and were allocated to seven subscales : Respiratory Complaints , Physical Functioning , Attendant Symptoms and Sleep , Social Relationships , Anxiety , Psychologic Well-Being , and Social Functioning . Cronbach 's alpha was > 0.7 in all subscales and > 0.8 in four subscales indicating high internal consistency reliability . Construct validity was confirmed by factor analysis , indicating one summary scale that accounts for 59.8 % of the variance . Concurrent validity was confirmed by correlating subscales of the SRI and the SF-36 ( 0.21<r<0.79 ) . Item-scale correlations revealed a high item discriminant validity . In addition , different diagnostic groups could be discriminated by the SRI . Here , the overall best HRQL was measured in the following order : patients with kyphoscoliosis , miscellaneous disorders , neuromuscular diseases , post-tuberculosis , and chronic obstructive pulmonary disease ( P<.05 ) . CONCLUSION The SRI is a new multidimensional instrument with high psychometric properties design ed to measure specific HRQL in patients with SRI receiving HMV SETTING Tuberculosis treatment clinic in Papua , Indonesia . OBJECTIVE To document the impact of pulmonary tuberculosis ( PTB ) on lung function , exercise tolerance and quality of life ( QOL ) . DESIGN A prospect i ve cohort study of 115 patients with smear-positive PTB followed for 6 months . Demographics , disease history , sputum microbiology , spirometry , 6-minute weight.walk distance ( 6MWWD ) and QOL ( modified St George 's Respiratory Question naire ) were measured at diagnosis and at 2 and 6 months . Analysis was restricted to the 69/115 ( 60 % ) subjects who attended all follow-up visits . RESULTS Subjects who attended all visits were less likely than the full cohort to be of Papuan ethnicity ( P < 0.05 ) , were more likely to be cured ( P < 0.001 ) and had better lung function at diagnosis ( P < 0.05 ) . Significant lung function impairment ( forced expiratory volume in 1 second [ FEV(1 ) ] < 60 % predicted ) was found in 27/69 ( 39 % ) at diagnosis . Although this fell during treatment ( P < 0.01 ) , 17/69 ( 24.6 % ) had persisting significant lung function impairment at treatment completion . As lung function recovered , exercise tolerance ( 6MWWD ) rose by 12.3 % ( P < 0.001 ) and QOL improved ( P < 0.001 ) . CONCLUSION In a high-burden setting , PTB causes prolonged , significant impairment of lung function , exercise tolerance and QOL . Current measures of disease burden are likely to underestimate the true impact of disease . Earlier diagnosis and disease-modifying treatments may reduce the long-term impact of PTB OBJECTIVES To evaluate the effects of antituberculosis treatment on the voice quality of laryngeal tuberculosis patients , measured by patient self- assessment , perceptual analysis and acoustic analysis . MATERIAL S AND METHODS A total of 14 laryngeal tuberculosis patients were enrolled . Laryngeal tuberculosis was established either by biopsy and histopathological examination or by rapid regression of the laryngeal lesions after antituberculosis medication . Before and after treatment , all patients were evaluated perceptually ( on a scale of zero to three ) , and 12 assessed their own voices using the voice h and icap index-10 scale . Acoustic analysis was performed to allow objective evaluation . RESULTS Patients ' ages ranged from 21 to 72 years ( mean , 41 ) . The male to female ratio was 12:2 . Eight patients ( 57 per cent ) had tuberculous involvement of the epiglottis , four ( 28 per cent ) had involvement of the aryepiglottic fold and eight ( 57 per cent ) had involvement of the false vocal folds . The glottis was the less commonly involved part of the larynx , including true vocal folds ( 28 per cent , n = 4 ) and posterior commissure ( 14 per cent , n = 2 ) . Perceptual evaluation , on a scale of zero to three , gave the patients a median score of six ; after commencement of treatment , the median score decreased to two . The mean voice h and icap index-10 score decreased from 24 to 12 after treatment . An obvious improvement in acoustic analytical parameters was also found following treatment . CONCLUSIONS Antituberculosis treatment clearly improved the voice outcomes of laryngeal tuberculosis patients , according to self- assessment , perceptual analysis and acoustic analysis OBJECTIVE To assess the impact of tuberculosis ( TB ) and its treatment on patients ' health status . METHODS Question naires were administered prospect ively to patients at three clinics in London at diagnosis and 2 months into therapy . We assessed generic health-related quality of life ( Short Form 36 [ SF-36 ] and EQ-5D ) and psychological burden ( State-Trait Anxiety Short-Form , Center for Epidemiologic Studies Depression Scale , worry items ) . RESULTS Of the 61 participants ( response rate 94 % ) , 89 % were non-UK born , 67 % had pulmonary TB and 38 % were aged 30 - 45 years . At diagnosis , scores for all eight SF-36 dimensions were significantly worse than UK general population norm scores . At follow-up , scores had improved significantly ( P < 0.01 ) , except for physical functioning and general health perception , but remained below the UK norm , except for vitality and mental health . Respondents ' mean anxiety and depression scores were high at diagnosis ( 48 and 22 , respectively ) , and anxiety scores remained high at follow-up . Worries most frequently reported concerned patients ' own health ( 92 % ) and that of their family ( 82 % ) . CONCLUSIONS TB patients suffer from significantly diminished health-related quality of life at diagnosis . Although treatment significantly improved patients ' health status within 2 months , scores for many domains remain below UK norm scores . This emphasises the importance of a holistic approach to care and should inform the evaluation of future interventions Objectives Non-invasive positive pressure ventilation ( NPPV ) improves health-related quality of life ( HRQL ) in patients with chronic alveolar hypoventilation ( CAH ) . We studied the prognostic impact of HRQL on survival in relation to clinical factors . Patients Forty-four patients with CAH due to post-polio ( 12 ) , scoliosis ( 11 ) , post-tb ( 17 ) or other diagnoses ( 4 ) who received nocturnal NPPV were prospect ively studied during 6–10 years . Measurements Blood gases and HRQL were analysed at baseline and after 9 months and after 8 years . HRQL was evaluated with measures of functioning ( SIP ) , emotional well-being ( HADS and MACL ) , and global QL . Results Blood gases and HRQL measures improved during NPPV . The overall 5-year survival rate was 73 % . In multivariate survival analysis , a diagnosis of post-polio and low baseline SIP physical index scores , indicating low levels of physical dysfunction , predicted longer survival ( P = 0.02 , respectively ) . Similarly , palliation of physical dysfunction and preserved or improved global QL by 9 months were associated with longer overall survival ( P = 0.009 and P = 0.001 , respectively ; multivariate Cox regression ) . ConclusionS eventy-three percent of patients treated for CAH with NPPV survived more than 5 years . Diagnosis and self-rated physical functioning at pre-treatment were related to survival , as were major improvements in physical functioning and global QL during NPPV BACKGROUND The Medical Outcomes Study 36-item Short Form ( SF-36 ) is a widely used measure of health-related quality of life . Normative data are the key to determining whether a group or an individual scores above or below the average for their country , age or sex . Published norms for the SF-36 exist for other countries but have not been previously published for Canada . METHODS The Canadian Multicentre Osteoporosis Study is a prospect i ve cohort study involving 9423 r and omly selected Canadian men and women aged 25 years or more living in the community . The sample was drawn within a 50-km radius of 9 Canadian cities , and the information collected included the SF-36 as a measure of health-related quality of life . This provided a unique opportunity to develop age- and sex-adjusted normative data for the Canadian population . RESULTS Canadian men scored substantially higher than women on all 8 domains and the 2 summary component scales of the SF-36 . Canadians scored higher than their US counterparts on all SF-36 domains and both summary component scales and scored higher than their UK counterparts on 4 domains , although many of the differences are not large . INTERPRETATION The differences in the SF-36 scores between age groups , sexes and countries confirm that these Canadian norms are necessary for comparative purpose s. The data will be useful for assessing the health status of the general population and of patient population s , and the effect of interventions on health-related quality of life A prospect i ve study was conducted on 90 patients of tuberculosis at 2 directly observed treatment short course ( DOTS ) cum microscopy centers in an urban area of Delhi . The WHOQOL-BREF ( Hindi ) question naire was used to assess the QOL at the onset of treatment , after 3 months of treatment under DOTS , and at completion of treatment . Patients with tuberculosis had significantly lower mean scores than controls for overall QOL . The most affected domains were physical and psychological . Women scored significantly better than men in the physical and environmental domains . Overall QOL scores were lowest for category II and significantly lower for the psychological and social domains . The mean scores after treatment were significantly lower than controls for overall QOL , the social and environmental domains . The DOTS regimen improves the QOL and its domains ; however , they remain significantly affected compared to the healthy
Output:
| Within individual studies and in meta-analyses , subjects with active TB disease consistently reported worse HRQOL than concurrently evaluated subjects treated for LTBI .
However , meaningful improvements in HRQOL throughout active TB treatment were reported by longitudinal studies .
Conclusions In a variety of studies , in different setting s and using different instruments , subjects with active TB consistently reported poorer HRQOL than persons treated for LTBI . |
MS211677 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Non-pharmacologic approaches to prevent bone loss are well suited for elderly patients to avoid polypharmacy and medication side effects . One potential treatment is a vibrating platform that delivers low-level mechanical loading stimulating bone remodeling . However , compliance is a major concern with any daily treatment , and is unknown for an elderly group using this device . Thus we assessed compliance with st and ing 10 min/day on a vibrating platform device in elderly women , the target population for osteoporosis therapy . We also assessed satisfaction with daily use of the device . We conducted a r and omized , placebo-controlled , double-blinded 6-month study for daily use of a 10-min vibrating platform treatment in elderly women who were residents of a Continuing Care Retirement community . Compliance for each subject was calculated as the number of days attended divided by the 182 days in the 6-month trial . The 24 elderly women ( mean age 86 , range 79–92 years ) had 83 % compliance ( 95 % CI : 70.5 , 94.5 ) for daily treatment over 6 months . Excluding three study drop-outs , the 21 women had 93 % compliance ( 95 % CI : 89.8 , 95.6 ) , with no difference in compliance between active and placebo treatment . Main reasons for missing treatment days over the 6 months were vacation ( 54 % of missed days ) and illness ( 29 % ) . Three adverse events occurred ; one ( syncope ) was possibly related to device use , whereas the other two were not related to device use . Among participants , 95 % reported overall satisfaction with daily use of the vibrating platform , and 57 % preferred the platform versus daily oral medications for prevention of bone loss . Elderly women showed high compliance , high satisfaction and few adverse experiences with a daily non-pharmacological treatment design ed to inhibit bone loss . Larger r and omized controlled trials should evaluate the long-term efficacy of vibrating platform devices for treatment of low bone mass and osteoporosis in elderly individuals OBJECTIVE To investigate the efficacy of high-frequency whole-body vibration ( WBV ) on balancing ability in elderly women . DESIGN R and omized controlled trial . Subjects were r and omized to either the WBV intervention or the no-treatment control group . SETTING Community-living elderly women . PARTICIPANTS Sixty-nine elderly women aged 60 or above without habitual exercise . INTERVENTION Side alternating WBV at 20Hz with 3 minutes a day and 3 days a week for 3 months in the WBV intervention group . Those in control group remained sedentary with normal daily life for the whole study period . MAIN OUTCOME MEASURES Limits of stability in terms of reaction time , movement velocity , directional control , endpoint excursion , maximum excursion , and the functional reach test were performed at baseline and endpoint . RESULTS Significant enhancement of stability was detected in movement velocity ( P<.01 ) , maximum point excursion ( P<.01 ) , in directional control ( P<.05 ) . CONCLUSIONS WBV was effective in improving the balancing ability in elderly women . This also provides evidence to support our user-friendly WBV treatment protocol of 3 minutes a day for the elderly to maintain their balancing ability and reduce risks of fall OBJECTIVES To investigate the effects of 24 weeks of whole-body-vibration ( WBV ) training on knee-extension strength and speed of movement and on counter-movement jump performance in older women . DESIGN A r and omized , controlled trial . SETTING Exercise Physiology and Biomechanics Laboratory , Leuven , Belgium . PARTICIPANTS Eighty-nine postmenopausal women , off hormone replacement therapy , aged 58 to 74 , were r and omly assigned to a WBV group ( n=30 ) , a resistance-training group ( RES , n=30 ) , or a control group ( n=29 ) . INTERVENTION The WBV group and the RES group trained three times a week for 24 weeks . The WBV group performed unloaded static and dynamic knee-extensor exercises on a vibration platform , which provokes reflexive muscle activity . The RES group trained knee-extensors by performing dynamic leg-press and leg-extension exercises increasing from low ( 20 repetitions maximum ( RM ) ) to high ( 8RM ) resistance . The control group did not participate in any training . MEASUREMENTS Pre- , mid- ( 12 weeks ) , and post- ( 24 weeks ) isometric strength and dynamic strength of knee extensors were measured using a motor-driven dynamometer . Speed of movement of knee extension was assessed using an external resistance equivalent to 1 % , 20 % , 40 % , and 60 % of isometric maximum . Counter-movement jump performance was determined using a contact mat . RESULTS Isometric and dynamic knee extensor strength increased significantly ( P<.001 ) in the WBV group ( mean+/-st and ard error 15.0+/-2.1 % and 16.1+/-3.1 % , respectively ) and the RES group ( 18.4+/-2.8 % and 13.9+/-2.7 % , respectively ) after 24 weeks of training , with the training effects not significantly different between the groups ( P=.558 ) . Speed of movement of knee extension significantly increased at low resistance ( 1 % or 20 % of isometric maximum ) in the WBV group only ( 7.4+/-1.8 % and 6.3+/-2.0 % , respectively ) after 24 weeks of training , with no significant differences in training effect between the WBV and the RES groups ( P=.391 ; P=.142 ) . Counter-movement jump height enhanced significantly ( P<.001 ) in the WBV group ( 19.4+/-2.8 % ) and the RES group ( 12.9+/-2.9 % ) after 24 weeks of training . Most of the gain in knee-extension strength and speed of movement and in counter-movement jump performance had been realized after 12 weeks of training . CONCLUSION WBV is a suitable training method and is as efficient as conventional RES training to improve knee-extension strength and speed of movement and counter-movement jump performance in older women . As previously shown in young women , it is suggested that the strength gain in older women is mainly due to the vibration stimulus and not only to the unloaded exercises performed on the WBV platform OBJECTIVE To test whether training on a high-frequency ( 28Hz ) vibrating platform improves muscle power and bone characteristics in postmenopausal women . DESIGN R and omized controlled trial with 6-month follow-up . SETTING Outpatient clinic in a general hospital in Italy . PARTICIPANTS Twenty-nine postmenopausal women ( intervention group , n=14 ; matched controls , n=15 ) . INTERVENTION Participants stood on a ground-based oscillating platform for three 2-minute sessions for a total of 6 minutes per training session , twice weekly for 6 months . The controls did not receive any training . Both groups were evaluated at baseline and after 6 months . MAIN OUTCOME MEASURES Muscle power , calculated from ground reaction forces produced by l and ing after jumping as high as possible on a forceplate , cortical bone density , and biomarkers of bone turnover . RESULTS Over 6 months , muscle power improved by about 5 % in women who received the intervention , and it remained unchanged in controls ( P=.004 ) . Muscle force remained stable in both the intervention and control groups . No significant changes were observed in bone characteristics . CONCLUSION Reflex muscular contractions induced by vibration training improve muscle power in postmenopausal women Background Whole-body vibration ( WBV ) is a new type of exercise that has been increasingly tested for the ability to prevent bone fractures and osteoporosis in frail people . There are two currently marketed vibrating plates : a ) the whole plate oscillates up and down ; b ) reciprocating vertical displacements on the left and right side of a fulcrum , increasing the lateral accelerations . A few studies have shown recently the effectiveness of the up- and -down plate for increasing Bone Mineral Density ( BMD ) and balance ; but the effectiveness of the reciprocating plate technique remains mainly unknown . The aim was to compare the effects of WBV using a reciprocating platform at frequencies lower than 20 Hz and a walking-based exercise programme on BMD and balance in post-menopausal women . Methods Twenty-eight physically untrained post-menopausal women were assigned at r and om to a WBV group or a Walking group . Both experimental programmes consisted of 3 sessions per week for 8 months . Each vibratory session included 6 bouts of 1 min ( 12.6 Hz in frequency and 3 cm in amplitude with 60 ° of knee flexion ) with 1 min rest between bouts . Each walking session was 55 minutes of walking and 5 minutes of stretching . Hip and lumbar BMD ( g·cm-2 ) were measured using dual-energy X-ray absorptiometry and balance was assessed by the blind flamingo test . ANOVA for repeated measurements was adjusted by baseline data , weight and age . Results After 8 months , BMD at the femoral neck in the WBV group was increased by 4.3 % ( P = 0.011 ) compared to the Walking group . In contrast , the BMD at the lumbar spine was unaltered in both groups . Balance was improved in the WBV group ( 29 % ) but not in the Walking group . Conclusion The 8-month course of vibratory exercise using a reciprocating plate is feasible and is more effective than walking to improve two major determinants of bone fractures : hip BMD and balance PURPOSE The aim of this study was to investigate the effects of different whole-body vibration ( WBV ) frequencies on oxygenation of vastus lateralis ( VL ) and gastrocnemius medialis ( GM ) muscles during static squatting in sedentary and physically active healthy males . METHODS Twenty volunteers ( age : 24.6 + /- 2.9 yr ; body mass : 80.6 + /- 11.8 kg ; height : 178.1 + /- 7.6 cm ) participated in this study . Ten subjects were sedentary individuals and 10 were athletes practicing different sports . All subjects completed four trials ( control , and 30- , 40- , and 50-Hz WBV ) in a r and omized controlled crossover design . The trials consisted of static squatting on a vibrating platform for a total duration of 110 s. Muscle-oxygenation status was recorded with near-infrared spectroscopy . RESULTS The data analysis revealed no significant treatment-by-time interactions in tissue-oxygenation index ( TOI ) or Delta total hemoglobin volume ( tHb ) in VL and GM muscles . A significant main effect of time in TOI of both VL and GM muscles was identified ( P<0.001 ) . VL TOI significantly decreased by 2.8 % at 90 s in the control condition and by 3.3 % at 110 s in the 30-Hz condition ; VL TOI significantly increased by 2.1 and 3.0 % at 30 s in the 40- and 50-Hz conditions , respectively . GM TOI significantly decreased by 3.2 % at 60 s , by 4.1 % at 90 s , and by 4.3 % at 110 s in the control condition , and by 5.5 % at 110 s in the 30-Hz condition . CONCLUSION This study showed that WBV exercise with frequencies of 30 , 40 , and 50 Hz and small amplitudes does not affect muscle oxygenation of VL and GM muscles to a higher degree than a nonvibration condition Background and aims : Exercise may enhance the effect of alendronate on bone mineral density ( BMD ) and reduce chronic back pain in elderly women with osteoporosis . The aim of this study was to determine whether whole-body vibration exercise would enhance the effect of alendronate on lumbar BMD and bone turnover , and reduce chronic back pain in post-menopausal women with osteoporosis . Methods : Fifty post-menopausal women with osteoporosis , 55–88 years of age , were r and omly divided into two groups of 25 patients each : one taking alendronate ( 5 mg daily , ALN ) and one taking alendronate plus exercise ( ALN+EX ) . Exercise consisted of whole-body vibration using a Galileo machine ( Novotec , Pforzheim , Germany ) , at an intensity of 20 Hz , frequency once a week , and duration of exercise 4 minutes . The study lasted 12 months . Lumbar BMD was measured by dual energy X-ray absorptiometry ( Hologic QDR 1500W ) . Urinary cross-linked N-terminal telopeptides of type I collagen ( NTX ) and serum alkaline phos-phatase ( ALP ) levels were measured by enzyme-linked immunosorbent assay and st and ard laboratory techniques , respectively . Chronic back pain was evaluated by face scale score at baseline and every 6 months . Results : There were no significant differences in baseline characteristics , including age , body mass index , years since menopause , lumbar BMD , urinary NTX and serum ALP levels , or face scale score between the two groups . The increase in lumbar BMD and the reduction in urinary NTX and serum ALP levels were similar in the ALN and ALN+EX groups . However , the reduction in chronic back pain was greater in the ALN+EX group than in the ALN group . Conclusions : The results of this study suggest that whole-body vibration exercise using a Galileo machine appears to be useful in reducing chronic back pain , probably by relaxing the back muscles in post-menopausal o
Output:
| Some but not all of the studies in this review reported similar improvements in muscle performance , balance , and functional mobility with WBV as compared to traditional exercise programs .
Bone studies consistently showed that WBV improved bone density in the hip and tibia but not in the lumbar spine . |
MS211678 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Investigators have reported improved endurance performance and attenuated post- exercise muscle damage with carbohydrate-protein beverages ( CHO+P ) versus carbohydrate-only beverages ( CHO ) . However , these benefits have been demonstrated only when CHO+P was administered in beverage-form , and exclusively in male subjects . Thus , the purpose s of this study were to determine if an oral CHO+P gel improved endurance performance and post-exercise muscle damage compared to a CHO gel , and determine if responses were similar between genders . Thirteen cyclists ( 8 men , 5 women ; & OV0312;O2peak = 57.9 ± 7.0 ml·kg-1·min-1 ) completed two timed cycle-trials to volitional exhaustion at 75 % of & OV0312;O2peak . At 15-minute intervals throughout these rides , subjects received CHO or CHO+P gels , which were matched for carbohydrate content ( CHO = 0.15 g CHO·kg BW-1 ; CHO+P = 0.15 g CHO + 0.038 g protein·kg BW-1 ) . Trials were performed using a r and omly counterbalanced , double-blind design . Subjects rode 13 % longer ( p > 0.05 ) when utilizing the CHO+P gel ( 116.6 ± 28.5 minutes ) versus the CHO gel ( 102.8 ± 25.0 minutes ) . In addition , men ( 101.8 ± 24.6 ; 114.8 ± 26.2 ) and women ( 104.4 ± 28.6 ; 119.6 ± 34.9 ) responded similarly to the CHO and CHO+P trials , with no significant treatment-by-gender effect . Postexercise creatine kinease ( CK ) was not significantly different between treatments . However , CK increased significantly following exercise in the CHO trial ( 183 ± 116 ; 267 ± 214 U·L-1 ) , but not the CHO+P trial ( 180 ± 133 ; 222 ± 141 U·L-1 ) . Therefore , to prolong endurance performance and prevent increases in muscle damage , it is recommended that male and female cyclists consume CHO+P gels rather than CHO gels during and immediately following exercise UNLABELLED Both time-to-exhaustion ( TTE ) and time-trial ( TT ) exercise tests are commonly used to assess exercise performance , but no study has directly examined the reliability of comparable tests in the same subjects . PURPOSE To evaluate the reliability of comparable TTE and TT treadmill running tests of high and moderately high exercise intensity in endurance-trained male distance runners , and to vali date Hinckson and Hopkins TT prediction methods using log-log modeling from TTE results . METHODS After familiarization tests , eight endurance-trained male distance runners performed , in a r and omized , counterbalanced order , eight trials consisting of two 5-km TT and two 1500-m TT , and four TTE tests run at a speed equivalent to the average speed attained during both the 5-km and 1500-m TT distances . RESULTS Typical error of the estimate ( TEE ) expressed as a coefficient of variation for the 5-km TT , 5-km TTE , 1500-m TT , and 1500-m TTE were 2.0 , 15.1 , 3.3 , and 13.2 % , respectively . The st and ard error of the estimate for predicted TT running speed using log-log modeling from TTE results was 0.67 % , and the predicted versus criterion reliability of this method revealed TEE values of 1.6 % and 2.5 % for the prediction of 5-km and 1500-m TT , respectively . CONCLUSION The variability of 5-km and 1500-m TT tests was significantly less than for similar TTE treadmill protocol s. Despite the greater variability of the TTE tests , log-log modeling using the TTE test results reliably predicted actual TT performance PURPOSE Fourteen male cyclists were studied to compare the effect of carbohydrate-protein-antioxidant beverage ( CHOPA ) to an isocaloric carbohydrate-only ( CHO ) beverage on time to fatigue and muscle damage . METHODS Subjects performed two sets of rides to exhaustion on a cycle ergometer . In each set , the first ride was performed at 70 % VO2peak , and the second was performed 24 h later at 80 % . CHO or CHOPA was consumed every 15 min during exercise and immediately afterward . Plasma CK and LDH and muscle soreness were measured pre- and postexercise . RESULTS Time to fatigue was not different between CHO and CHOPA at 70 % VO2peak ( 95.8 + /- 29.7 vs 98.1 + /- 28.7 min ) , 80 % VO2peak ( 42.3 + /- 18.6 vs 42.9 + /- 21.8 min ) , or total performance time ( 138.1 + /- 39.3 vs 140.9 + /- 43.7 min ) . Postexercise CK was increased ( P < 0.05 ) from baseline in CHO ( 203 + /- 120 vs 582 + /- 475 U.L(-1 ) ) but not with CHOPA ( 188 + /- 119 vs 273 + /- 169 U.L(-1 ) ) . Similarly , LDH values increased over baseline in CHO ( 437 + /- 46 vs 495 + /- 64 U.L(-1 ) ) but not with CHOPA ( 432 + /- 40 vs 451 + /- 43 U.L(-1 ) ) . Postexercise CPK and LDH were higher after the CHO trial than after the CHOPA trial . Median postexercise muscle soreness was higher in CHO ( 3.0 + /- 5.0 ) than with CHOPA ( 1.0 + /- 3.0 ) . CONCLUSION No differences in time to fatigue were observed between the beverages , despite lower total carbohydrate content in the CHOPA beverage . The CHOPA beverage attenuated postexercise muscle damage , as evidence d by CK and LDH values , compared with an isocaloric CHO beverage This study examined the effects of 3 recovery drinks on endurance performance following glycogen-depleting exercise . Nine trained male cyclists performed 3 experimental trials , in a r and omized counter-balanced order , consisting of a glycogen-depleting trial , a 4-h recovery period , and a cycle to exhaustion at 70 % power at maximal oxygen uptake . At 0 and 2 h into the recovery period , participants consumed chocolate milk ( CM ) , a carbohydrate replacement drink ( CR ) , or a fluid replacement drink ( FR ) . Participants cycled 51 % and 43 % longer after ingesting CM ( 32 + /- 11 min ) than after ingesting CR ( 21 + /- 8 min ) or FR ( 23 + /- 8 min ) . CM is an effective recovery aid after prolonged endurance exercise for subsequent exercise at low-moderate intensities Coingestion of protein with carbohydrate ( CHO ) during recovery from exercise can affect muscle glycogen synthesis , particularly if CHO intake is suboptimal . Another potential benefit of protein feeding is an increased synthesis rate of muscle proteins , as is well documented after resistance exercise . In contrast , the effect of nutrient manipulation on muscle protein kinetics after aerobic exercise remains largely unexplored . We tested the hypothesis that ingesting protein with CHO after a st and ardized 2-h bout of cycle exercise would increase mixed muscle fractional synthetic rate ( FSR ) and whole body net protein balance ( WBNB ) vs. trials matched for total CHO or total energy intake . We also examined whether postexercise glycogen synthesis could be enhanced by adding protein or additional CHO to a feeding protocol that provided 1.2 g CHO x kg(-1 ) x h(-1 ) , which is the rate generally recommended to maximize this process . Six active men ingested drinks during the first 3 h of recovery that provided either 1.2 g CHO.kg(-1).h(-1 ) ( L-CHO ) , 1.2 g CHO + 0.4 g protein x kg(-1 ) x h(-1 ) ( PRO-CHO ) , or 1.6 g CHO x kg(-1 ) x h(-1 ) ( H-CHO ) in r and om order . Based on a primed constant infusion of l-[ring-(2)H(5)]phenylalanine , analysis of biopsies ( vastus lateralis ) obtained at 0 and 4 h of recovery showed that muscle FSR was higher ( P < 0.05 ) in PRO-CHO ( 0.09 + /- 0.01%/h ) vs. both L-CHO ( 0.07 + /- 0.01%/h ) and H-CHO ( 0.06 + /- 0.01%/h ) . WBNB assessed using [1-(13)C]leucine was positive only during PRO-CHO , and this was mainly attributable to a reduced rate of protein breakdown . Glycogen synthesis rate was not different between trials . We conclude that ingesting protein with CHO during recovery from aerobic exercise increased muscle FSR and improved WBNB , compared with feeding strategies that provided CHO only and were matched for total CHO or total energy intake . However , adding protein or additional CHO to a feeding strategy that provided 1.2 g CHO x kg(-1 ) x h(-1 ) did not further enhance glycogen re synthesis during recovery Nine male , endurance-trained cyclists performed an interval workout followed by 4 h of recovery , and a subsequent endurance trial to exhaustion at 70 % VO2max , on three separate days . Immediately following the first exercise bout and 2 h of recovery , subjects drank isovolumic amounts of chocolate milk , fluid replacement drink ( FR ) , or carbohydrate replacement drink ( CR ) , in a single-blind , r and omized design . Carbohydrate content was equivalent for chocolate milk and CR . Time to exhaustion ( TTE ) , average heart rate ( HR ) , rating of perceived exertion ( RPE ) , and total work ( WT ) for the endurance exercise were compared between trials . TTE and WT were significantly greater for chocolate milk and FR trials compared to CR trial . The results of this study suggest that chocolate milk is an effective recovery aid between two exhausting exercise bouts This study examined whether a carbohydrate + casein hydrolysate ( CHO+ProH ) beverage improved time-trial performance vs. a CHO beverage delivering approximately 60 g CHO/hr . Markers of muscle disruption and recovery were also assessed . Thirteen male cyclists ( VO2peak = 60.8 + /- 1.6 ml . kg-1 . min-1 ) completed 2 computer-simulated 60-km time trials consisting of 3 laps of a 20-km course concluding with a 5-km climb ( approximately 5 % grade ) . Participants consumed 200 ml of CHO ( 6 % ) or CHO+ProH beverage ( 6 % + 1.8 % protein hydrolysate ) every 5 km and 500 ml of beverage immediately postexercise . Beverage treatments were administered using a r and omly counterbalanced , double-blind design . Plasma creatine phosphokinase ( CK ) and muscle-soreness ratings were assessed immediately before and 24 hr after cycling . Mean 60-km times were 134.4 + /- 4.6 and 135.0 + /- 4.0 min for CHO+ProH and CHO beverages , respectively . All time differences between treatments occurred during the final lap , with protein hydrolysate ingestion explaining a significant ( p < .05 ) proportion of between-trials differences over the final 20 km ( 44.3 + /- 1.6 , 45.0 + /- 1.6 min ) and final 5 km ( 16.5 + /- 0.6 , 16.9 + /- 0.6 min ) . Plasma CK levels and muscle-soreness ratings increased significantly after the CHO trial ( 161 + /- 53 , 399 + /- 175 U/L ; 15.8 + /- 5.1 , 37.6 + /- 5.7 mm ) but not the CHO+ProH trial ( 115 + /- 21 , 262 + /- 88 U/L ; 20.9 + /- 5.3 , 32.2 + /- 7.1 mm ) . Late-exercise time-trial performance was enhanced with CHO+ProH beverage ingestion compared with a beverage containing CHO provided at maximal exogenous oxidation rates during exercise . CHO+ProH ingestion also prevented increases in plasma CK and muscle soreness after exercise Abstract Carbohydrate intake during endurance exercise delays the onset of fatigue and improves performance . Two recent cycling studies have reported increased time to exhaustion when protein is ingested together with carbohydrate . The purpose of the present study was to test the hypothesis that ingestion of a carbohydrate + protein beverage will lead to significant improvements in cycling time-trial performance relative to placebo and carbohydrate alone . Thirteen cyclists completed 120 min of constant-load erg
Output:
| We conclude that compared to carbohydrate alone , coingestion of protein and carbohydrate during exercise demonstrated an ergogenic effect on endurance performance when assessed by time to exhaustion and also where supplements were matched for carbohydrate ( isocarbohydrate ) .
Thus , the ergogenic effect of protein seen in isocarbohydrate studies may be because of a generic effect of adding calories ( fuel ) as opposed to a unique benefit of protein . |
MS211679 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Osteoporosis-related fractures are associated with reductions in health-related quality of life ( HRQL ) . We examined the benefits of zoledronic acid ( ZOL ) on HRQL in patients sustaining vertebral and clinical fractures from HORIZON-Pivotal Fracture Trial using mini-Osteoporosis quality of life Question naire ( OQLQ ) . In this multicenter , double-blind , placebo-controlled trial , 1434 patients from a cohort of postmenopausal women with osteoporosis ( mean age 73years ) were r and omized to receive annual infusions of ZOL 5 mg or placebo for 3years . Baseline HRQL scores were comparable between ZOL and placebo groups based on the presence or absence of fractures , with exception of prevalent vertebral fractures where patients ( irrespective of the treatment group ) had lower baseline HRQL scores than those without prevalent vertebral fractures . Greater number of prevalent vertebral fractures was associated with lower baseline HRQL ( p<0.001 ) . No significant difference between ZOL and placebo in the overall summary score was observed but a significant benefit was noted in certain domains with ZOL , especially in patients sustaining incident clinical fractures . Improvements in HRQL were marked at first assessment after a morphometric vertebral fracture with significant differences favouring ZOL in pain ( p=0.0115 ) , st and ing pain ( p=0.0125 ) ) , physical ( lifting , p=0.0333 ) and emotional function ( fear of fractures , p=0.0243 ; fear of falls , p=0.0075 ) but not for activities of daily living or leisure domains . HRQL is reduced in patients with vertebral fractures . Treatment with ZOL over 3years was associated with improvements in specific domains of quality of life vs. placebo , particularly in patients sustaining incident fractures The construction of reference ranges that accurately represent the population at large is essential for the correct identification of osteoporosis from bone mineral density ( BMD ) measurements . In this study , reference data supplied by the manufacturer of the Lunar DPX+ bone densitometer were compared with data obtained locally . Lumbar spine , proximal femur and total body BMD measurements were made in an age-stratified r and om sample of 702 Southampton women aged 20 to 89 years . Relevant demographic and medical data were recorded for each subject using a question naire . Reference curves of BMD ( mean + /- SD ) were plotted against age for each measurement site and were found to be higher than the manufacturer 's reference values at all ages and sites . Exclusion of women with factors known to affect bone mass only served to increase this discrepancy . According to World Health Organisation definitions , osteoporosis may be identified from BMD values alone . Based upon neck of femur BMD values , 100 ( 14.8 % ) of the women in this study group were categorized as osteoporotic using local young normal reference data , compared with only 39 ( 5.8 % ) using the manufacturer 's data . By normalizing for age distribution , these findings were extrapolated to the local population where it was predicted that 26.0 % and 10.1 % of females over 50 years of age would be classified as osteoporotic using the respective reference ranges . This study clearly illustrates how the numbers of women diagnosed as osteoporotic vary with the use of different reference population Background The aim of this study is to vali date the question naire ECOS-16 ( Assessment of health related quality of life in osteoporosis ) for the evaluation of health related quality of life ( HRQoL ) in post-menopausal women with osteoporosis . Methods An observational , prospect i ve and multi-centre study was carried out among post-menopausal women with osteoporosis in primary care centres and hospital outpatient clinics . All patients attended 2 visits : at baseline and at 6 months . In addition , the subgroup of out patients attended another visit a month after the baseline to assess the test-retest reliability . The psychometric properties of the question naire were evaluated in terms of feasibility , validity ( content validity and construct validity ) and internal consistency in baseline , and in terms of test-retest reliability and responsiveness to change in visit at month and visit at 6 months , respectively . In all visits , ECOS-16 , EUROQoL-5D ( EQ-5D ) and four 7-point items about health status ( general health status , back pain , limitation in daily activities and emotional status ) were administered , whereas only out patients were given MINI-OQLQ ( Mini Osteoporosis Quality of Life Question naire ) , besides all clinical variables ; and sociodemographic variables at baseline . Results 316 women were consecutively included , 212 from primary care centres and 104 from hospital outpatient clinics . Feasibility : 94.3 % of patients answered all items of the question naire . The mean administration time was 12.3 minutes . Validity : factor analysis suggested that the question naire was unidimensional . In the multivariate analysis , patients with vertebral fractures , co-morbidity and a lower education level showed to have worse HRQoL. Moderate to high correlations were found between the ECOS-16 score and the other health status question naires ( 0.47–0.82 ) . Reliability : internal consistency ( Cronbach 's α ) was 0.92 and test-retest reliability ( ICC ) was 0.80 . Responsiveness to change : ECOS-16 scores increased according to change perceived by the patient , as well as the effect size ( ranges between 1.35 to 0.43 ) , the greater the perception of change in patients ' general health status , the greater the changes in patients ' scores . The Minimal Clinical ly Important Difference ( MCID ) suggested a change of 0.5 points in the ECOS-16 score , representing the least improvement in general health status due to their osteoporosis : " slightly better " . Conclusion ECOS-16 has been proven preliminarily to have good psychometric properties , so that it can be potentially a useful tool to evaluate HRQoL of post-menopausal women with osteoporosis in research and routine clinical practice Objectives : There have been no studies of generic health-related quality of life ( HR-QOL ) measured prospect ively , in patients referred for bone mass measurement . The aim of this study was to examine the relationship between HR-QOL , measured before DXA scanning was undertaken , and bone mineral density ( BMD ) . Comparison of HR-QOL with the age- and sex-matched general population was also made . Design : HR-QOL question naires were completed by patients who were being entered into a r and omized , prospect i ve , parallel group trial to assess the impact of direct access DXA scanning ( DADS ) versus referral to a hospital consultant , upon clinical decision making by general practitioners ( GPs ) ( Dhillon et al. , Osteoporos Int 14:326–333 , 2003 ) . HR-QOL question naires were completed prior to both r and omization and DXA scanning . Participants : 325 patients from18 representative general practice s of a total of 77 in the city of Edinburgh . Patients had been referred by their GPs who had access to national guidelines on the identification of patients at high risk of osteoporosis . Outcome measures : Generic HR-QOL was measured using Euroqol ( EQ5D ) . This provides a profile of self-reported problems in five dimensions ( EQ5Dprofile ) , health utility ( EQ5Dutility ) , and a visual analogue global self-rated health assessment ( EQ5Dvas ) . Results : Odds ratios ( ORs ) for any self-reported problems on EQ5Dprofile were higher in patients with osteoporosis than those without , and compared with the general population . Age-adjusted mean ( SD ) EQ5Dutility was significantly lower in patients with osteoporosis than in those without ( 0.65 [ 0.28 ] vs 0.76 [ 0.27 ] ; p<0.01 ) , but the difference lessened with advancing age . Age-adjusted mean ( SD ) EQ5Dvas was significantly reduced in patients with compared with no osteoporosis ( 68 [ 20 ] vs 76 [ 16 ] ; p<0.01 ) . There were no such differences in patients with a history of prior fracture compared with those without a history of prior fracture . Conclusions : Female patients with osteoporosis have reduced generic HR-QOL compared with the age-matched female general population , irrespective of a history of prior fracture . The causal relationship between osteoporosis and HR-QOL , if any , is unclear . Further studies are needed to define this relationship and to determine whether treatment of osteoporosis has a beneficial effect on HR-QOL independent of fracture risk Data are scarce on the impact of vertebral fractures ( VFX ) on utility . The objective of this study was to assess the impact of prevalent and incident VFX on utility in both a patient-based and population -based sample . Data from the Multiple Outcomes of Raloxifene Evaluation ( MORE ) study ( n = 550 for prevalent VFX and n = 174 for incident VFX ) and the European Prospect i ve Osteoporosis Study ( EPOS ) ( n = 236 ) were used . Utility was assessed by the index score of the EQ-5D . In the MORE study , highly statistically significant associations were found between utility and the presence of prevalent VFX ( p < 0.001 ) , number of prevalent VFX ( p < 0.001 ) , severity of prevalent VFX ( p < 0.001 ) , the combination of number and severity of prevalent VFX ( p = 0.001 ) and location of prevalent VFX ( p = 0.019 ) . The mean utility was significantly lower among women who suffered an incident VFX ( utility = 0.67 ) than among women who did not ( utility = 0.77 ) ( p = 0.005 ) , although utility loss was not significantly different between the two groups ( p = 0.142 ) . In EPOS , the combination of number and severity of incident VFX was significantly related to utility ( p = 0.030 ) . In conclusion , utility is lower among persons with prevalent and incident VFX , especially in a patient-based sample . Utility loss was not significantly different between women without and with incident VFX Although the long-term outcomes of osteoporosis ( Op ) such as fracture , kyphosis , and pain are well known , the physical , psychological , and social consequences , beyond fracture and pain , are less clear . The Osteoporosis-targeted Quality -of-life ( OPTQoL ) question naire aim ed at assessing the physical difficulty , fears , and adaptations to one 's daily life was developed as a cross-sectional instrument to characterize the burden of Op within a community . The purpose of this study was to assess the impact of Op and related factors on community women participating in the OFELY study in France . Femoral neck bone mineral density ( BMD ) and OPTQoL question naire data were collected from women r and omly selected from a large insurance company . Data were obtained for 756 women ( mean age 59 years , range 36 - 92 ) , most of whom were white . Women were classified into five groups based on the extent of physical manifestations and family history of Op . Women who had prior fractures , height loss , and /or kyphosis or both reported greater physical difficulty , more adaptations to their lives , and greater fears than women reporting no such changes . Scores on the Physical Difficulty domain , however , did not differ significantly based on BMD alone ( BMD T score < or=2.5 ) , after controlling for age and self-reported arthritis . The negative impact of Op on quality -of-life ( QoL ) seems to be more related to the physical manifestations of Op than to bone density levels . Recognition of the impact of Op-related factors on QoL may help health-care providers more fully appreciate the importance of prevention and treatment Fractures and subsequent morbidity determine the impact of established postmenopausal osteoporosis . Health-related quality of life ( HRQOL ) has become an important outcome criterion in the assessment and follow-up of osteoporotic patients . As part of the baseline measurements of the Multiple Outcomes of Raloxifene Evaluation ( MORE ) study , HRQOL was assessed in 751 osteoporotic ( bone mineral density [ BMD ] T score > or = -2.5 ) women from Europe with or without vertebral fractures ( VFX ) . This was done using the quality of life question naire of the European Foundation for Osteoporosis ( QUALEFFO ) , Nottingham Health Profile ( NHP ) and the EQ-5D ( former EuroQol ) . QUALEFFO contains questions in five domains : pain , physical function , social function , general health perception , and mental function . Each domain score and QUALEFFO total scores are expressed on a 100-point scale , with 0 corresponding to the best HRQOL . In comparison with patients without VFX , those with VFX were older ( 66.2 + /- 5.9 years vs. 68.8 + /- 6.3 years ; p < 0.001 ) , had higher prevalence of nonvertebral fractures ( 25 % vs. 36 % ; p = 0.002 ) , and higher QUALEFFO scores ( worse HRQOL ; total score , 26 + /- 14 vs. 36 + /- 17 ; p < 0.001 ) . QUALEFFO scores increased progressively with increasing number of VFX , especially lumbar fractures ( p < 0.001 ) . Patients with a single VFX already had a significant increase in QUALEFFO scores
Output:
| Using Qualeffo-41 , pain and physical function were worse in these patients .
Also , HRQoL was related to upper femur , but not lumbar spine BMD .
HRQoL data in patients with osteoporosis without VFX are limited and variable but suggest that HRQoL is adversely affected by osteoporosis in the absence of VFX .
The association of lower BMD and worse HRQoL suggests that more attention should be paid to HRQoL in those without VFX . |
MS211680 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: ABSTRACT Data from a double-blind r and omized clinical drug trial were analyzed to find the comparative responses of two antirelapse drugs , bulaquine and primaquine , against different relapsing forms ofPlasmodium vivax infection . A 1-year follow-up study strongly suggests that the duration of preerythrocytic development ofP. vivax is a polymorphic characteristic , exhibited by two strains of hypnozoites responsible for early and late manifestations after primary infection . Short-term relapses were significantly higher in the first half year than long-term relapses , and the reverse was true in the second half year . Clinical drug response data showed that the hypnozoites characterized for short-term relapse were not susceptible to either of the antirelapse drugs in the currently administered dose , whereas hypnozoites characterized for long incubation were significantly susceptible We studied the antirelapse efficacy of a supervised 14-d 15 mg/d regimen of primaquine therapy ( n = 131 ) compared with no antirelapse therapy ( n = 142 ) in 273 patients with confirmed Plasmodium vivax malaria in Mumbai , India , between July 1998 and April 2000 . There were 6/131 ( 4.6 % ) recurrences in patients given primaquine compared with 13/142 ( 9.2 % ) in those not given antirelapse therapy . In the 14-d primaquine group , polymerase chain reaction-single str and conformational polymorphism ( PCR-SSCP ) genotyping analysis of pre- and post-treatment blood sample s was done for the 6 patients who had a recurrence of parasitaemia and the results gave a true relapse rate of 2.29 % ( 3/131 ) , 2 sample s were classified as reinfections and 1 sample did not amplify . Our results indicate probable resistance to the 14-d regimen of primaquine for the first time in India and illustrate the need to ( i ) monitor patients given this regimen and ( ii ) carry out comparative studies between primaquine and new drugs such as tafenoquine and bulaquine for preventing relapses A study conducted in 1994 showed that the use of blister packs containing antimalarial drugs significantly increased patients ' compliance , compared with traditional means of dispensing drugs in a paper envelope . The present study assessed patients ' compliance and compared the difference between 3-day chloroquine and 8-day primaquine courses of treatment for vivax malaria . The level of real compliance was determined by making the drugs with phenobarbital , and measuring its level in the blood following treatment . The results show that blister packaging significantly improved patients ' compliance ( p < 0.001 ) over traditional means of dispensing antimalarial drugs ; there was no difference in treatment compliance between 3-day and 8-day courses when the drugs were in blister packs . However , with ordinary packaging the treatment compliance rate for an 8-day course was significantly less than for a 3-day course ( P < 0.05 ) Malaria causes illness or death in unprotected travelers . Primaquine prevents malaria by attacking liver-stage parasites , a property distinguishing it from most chemoprophylactics and obviating 4-week postexposure dosing . A daily adult regimen of 30 mg primaquine prevented malaria caused by Plasmodium falciparum and P. vivax for 20 weeks in 95 of 97 glucose-6-phosphate dehydrogenase (G6PD)-normal Javanese transmigrants in Papua , Indonesia . In comparison , 37 of 149 subjects taking placebo in a parallel trial became parasitemic . The protective efficacy of primaquine against malaria was 93 % ( 95 % confidence interval [ CI ] 71%-98 % ) ; against P. falciparum it was 88 % ( 95 % CI 48%-97 % ) , and > 92 % for P. vivax ( 95 % CI > 37%-99 % ) . Primaquine was as well tolerated as placebo . Mild methemoglobinemia ( mean of 3.4 % ) returned to normal within 2 weeks . Blood chemistry and hematological parameters revealed no evidence of toxicity . Good safety , tolerance , and efficacy , along with key advantages in dosing requirements , make primaquine an excellent drug for preventing malaria in nonpregnant , G6PD-normal travelers We conducted a study to compare the safety and tolerability of anti-relapse drugs elubaquine and primaquine against Plasmodium vivax malaria . After st and ard therapy with chloroquine , 30 mg/kg given over 3 days , 141 patients with P. vivax infection were r and omized to receive primaquine or elubaquine . The 2 treatment regimens were primaquine 30 mg once daily for 7 days ( group A , n = 71 ) , and elubaquine 25 mg once daily for 7 days ( group B , n = 70 ) . All patients cleared parasitemia within 7 days after chloroquine treatment . Among patients treated with primaquine , one patient relapsed on day 26 ; no relapse occurred with elubaquine treatement . Both drugs were well tolerated . Adverse effects occurred only in patients with G6PD deficiency who were treated with primaquine ( group A , n = 4 ) , whose mean hematocrit fell significantly on days 7 , 8 and 9 ( P = 0.015 , 0.027 , and 0.048 , respectively ) . No significant change in hematocrit was observed in patients with G6PD deficiency who were treated with elubaquine ( group B , n = 3 ) or in patients with normal G6PD . In conclusion , elubaquine , as anti-relapse therapy for P. vivax malaria , was as safe and well tolerated as primaquine and did not cause clinical ly significant hemolysis Vivax malaria accounts for 80 % of malaria cases in Mumbai ( Bombay ) and has high morbidity . In India , the st and ard treatment to prevent relapses of vivax malaria is a 5-day regimen of primaquine . However , between 1977 and 1997 , the efficacy of this treatment declined from approximately 99 % to 87 % . The efficacy of the 5-day regimen was therefore compared with that of the 14-day regimen currently recommended by the World Health Organization , in Mumbai . The relapse rates observed , over a 6-month period of follow-up , were 0 % with the 14-day regimen , 26.7 % with the 5-day , and 11.7 % when no primaquine treatment was given . The expenditure incurred on the door-to-door dispensing of the 5-day regimen appears to be without benefit . There is an urgent need to review the present strategy for controlling relapses in vivax malaria , at least for the city of Mumbai , and similar studies need to be carried out in other parts of India , to make all anti-relapse strategies more appropriate BACKGROUND Tafenoquine is an 8-aminoquinoline developed as a more effective replacement for primaquine . In a previous dose-ranging study in Thail and , 3 tafenoquine regimens with total doses ranging from 500 mg to 3000 mg prevented relapse of Plasmodium vivax malaria in most patients when administered 2 days after receipt of a blood schizonticidal dose of chloroquine . METHODS To improve convenience and to begin comparison of tafenoquine with primaquine , 80 patients with P. vivax infection were r and omized to receive 1 of the following 5 treatments 1 day after receiving a blood schizonticidal dose of chloroquine : ( A ) tafenoquine , 300 mg per day for 7 days ( n=18 ) ; ( B ) tafenoquine , 600 mg per day for 3 days ( n=19 ) ; ( C ) tafenoquine , 600 mg as a single dose ( n=18 ) ; ( D ) no further treatment ( n=13 ) ; or ( E ) primaquine base , 15 mg per day for 14 days ( n=12 ) . The minimum duration of protocol follow-up was 8 weeks , with additional follow-up to 24 weeks . RESULTS Forty-six of 55 tafenoquine recipients , 10 of 13 recipients of chloroquine only , and 12 of 12 recipients of chloroquine plus primaquine completed at least 8 weeks of follow-up ( or had relapse ) . There was 1 relapse among recipients of chloroquine plus tafenoquine , 8 among recipients of chloroquine only , and 3 among recipients of chloroquine plus primaquine . The rate of protective efficacy ( determined on the basis of reduction in incidence density ) for all recipients of chloroquine plus tafenoquine , compared with recipients of chloroquine plus primaquine , was 92.6 % ( 95 % confidence interval , 7.3%-99.9 % ; P=.042 , by Fisher 's exact test ) . CONCLUSIONS Tafenoquine doses as low as a single 600-mg dose may be useful for prevention of relapse of P. vivax malaria in Thail and For over 4 decades the antimalarial program in India has been prescribing a 5-day primaquine regimen as an antirelapse therapy to treat Plasmodium vivax malaria . In view of conflicting reports on the effectiveness of this regimen in the Indian subcontinent , and the varying prevalence of P. vivax in various ecosystems in India , the antirelapse efficacy of this regimen was evaluated in Orissa , a malaria endemic state in eastern India where P. falciparum predominates . In 723 cases of P. vivax infection treated with chloroquine alone and followed up weekly for 1 yr , the prevalence of recurrence of parasitaemia with fever was 8.6 % . Among another 759 P. vivax cases treated with chloroquine and a 5-day regimen of primaquine at 15 mg/day ( adult dose ) , the recurrence of infection was 6.5 % . The difference in recurrence was not significant ( P = 0.53 ) . It is important to note that in a great majority of cases of P. vivax in this area , infection did not recur even without treatment with primaquine . This finding , that the use of the 5-day primaquine regimen with chloroquine had no significant advantage over the use of chloroquine alone , undermines the rationale of using primaquine as an antirelapse drug in forested areas with a high prevalence of P. falciparum Chloroquine has been the st and ard treatment for Plasmodium vivax malaria for more than 40 years in most regions of the world . Recently , however , chloroquine-resistant P. vivax has been reported from Oceania , several parts of Asia , and South America . In order to assess the situation in Thail and , 886 patients with vivax malaria who were admitted to the Bangkok Hospital for Tropical Diseases from 1992 to 1997 were followed prospect ively . Most of the patients had been infected on the western border of Thail and and were experiencing their first malarial infection when admitted . All received oral chloroquine ( approximately 25 mg base/kg body weight , administered over 3 days ) and then were r and omized to receive primaquine ( 15 mg daily for 14 days ) or no further treatment . All the patients were initially responsive to chloroquine , clearing their parasitaemias within 7 days , and there were no significant differences in the clinical or parasitological responses between those treated with primaquine and those given no further treatment . Plasmodium vivax parasitaemias re-appeared within 28 days of chloroquine treatment in just four patients . In each of these four cases , re-treatment with the same regimen of chloroquine result ed in eradication of the parasitaemia , with no further appearance of parasitaemia during the next , 28-day , follow-up period . These data indicate that virtually all acute ( i.e. blood-stage ) P. vivax infections acquired in Thail and can still be successfully treated with chloroquine OBJECTIVES : In the treatment of vivax malaria , an important factor affecting the occurrence of relapse is the duration of treatment . In Belém , a number of patients with vivax malaria were found to be cured despite failure to complete the st and ard course of treatment . In Belém , a number of patients with vivax malaria were found to be cured despite failure to complete the st and ard course of treatment . This observation suggested the present study , investigating more practicable courses of treatment for children with vivax malaria . METHODS : A r and omized prospect i ve clinical trial was conducted in 200 outpatient children with vivax malaria . Parasite clearance time and response to four therapeutic schedules were investigated : a ) chloroquine * , 10 mg/kg in a single dose ( chloroquine SD ) + primaquine , 0.50 mg/kg/dose for 7 days ; b ) chloroquine SD + primaquine , 0.25 mg/kg/dose for 7 days ; c ) chloroquine SD + primaquine , 0.50 mg/kg/dose for 5 days ; d ) chloroquine SD + primaquine , 0.25 mg/kg/dose for 5 days . Fisherśs Exact test was used to compare the responses to the schedules . RESULTS : All 144 children who completed the study had clearance of asexual parasitem
Output:
| AUTHORS ' CONCLUSIONS Primaquine ( 15 mg/kg/day for 14 days ) plus chloroquine is more effective than chloroquine alone or primaquine ( 15 mg/kg for 5 days ) plus chloroquine in preventing relapses of vivax malaria .
Primaquine ( five days ) plus chloroquine appears no better than chloroquine . |
MS211681 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Early interventions proved to be able to improve prognosis in acute stroke patients . Prompt identification of symptoms , organised timely and efficient transportation towards appropriate facilities , become essential part of effective treatment . The implementation of an evidence based pre-hospital stroke care pathway may be a method for achieving the organizational st and ards required to grant appropriate care . We performed a systematic search for studies evaluating the effect of pre-hospital and emergency interventions for suspected stroke patients and we found that there seems to be only a few studies on the emergency field and none about implementation of clinical pathways . We will test the hypothesis that the adoption of emergency clinical pathway improves early diagnosis and referral in suspected stroke patients . We design ed a cluster r and omised controlled trial ( C- RCT ) , the most powerful study design to assess the impact of complex interventions . The study was registered in the Current Controlled Trials Register : IS RCT N41456865 – Implementation of pre-hospital emergency pathway for stroke – a cluster r and omised trial . Methods / design Two-arm cluster-r and omised trial ( C- RCT ) . 16 emergency services and 14 emergency rooms were r and omised either to arm 1 ( comprising a training module and administration of the guideline ) , or to arm 2 ( no intervention , current practice ) . Arm 1 participants ( 152 physicians , 280 nurses , 50 drivers ) attended an interactive two sessions course with continuous medical education CME credits on the contents of the clinical pathway . We estimated that around 750 patients will be met by the services in the 6 months of observation . This duration allows recruiting a sample of patients sufficient to observe a 30 % improvement in the proportion of appropriate diagnoses . Data collection will be performed using current information systems . Process outcomes will be measured at the cluster level six months after the intervention . We will assess the guideline recommendations for emergency and pre-hospital stroke management relative to : 1 ) promptness of interventions for hyperacute ischaemic stroke ; 2 ) promptness of interventions for hyperacute haemorrhagic stroke 3 ) appropriate diagnosis . Outcomes will be expressed as proportions of patients with a positive CT for ischaemic stroke and symptoms onset < = 6 hour admitted to the stroke unit . Discussion The fields in which this trial will play are usually neglected by R and omised Controlled Trial ( RCT ) . We have chosen the Cluster-r and omised Controlled Trial ( C- RCT ) to address the issues of contamination , adherence to real practice , and community dimension of the intervention , with a complex definition of clusters and an extensive use of routine data to collect the outcomes Background and Purpose — Integrated care pathways ( ICP ) may not reduce disability , institutionalization , or duration of hospitalization compared with conventional multidisciplinary team ( MDT ) care in organized stroke rehabilitation . Their potential to improve patient heath status or satisfaction with care is not known . Methods — A comparison of quality of life , caregiver strain , and patient/caregiver satisfaction at 6 months after stroke was undertaken in 152 stroke patients r and omized to receive ICP or MDT care . Differences in processes of care were recorded with the use of a predefined schedule . Multivariate analyses were undertaken to identify the effect of age , sex , stroke severity , functional status , mood , and use of care pathway on quality of life score . Results — The 2 groups were comparable for baseline characteristics of age , sex , stroke severity , and initial disability . MDT care was characterized by greater emphasis on return of higher function and caregiver needs compared with ICP . EuroQol Visual Analogue Scale ( EQ-VAS ) scores were higher in the MDT group ( median , 72 versus 63;P < 0.005 ) , who also had higher scores for EuroQol dimension of social functioning ( P = 0.014 ) . Higher EQ-VAS scores were independently related to MDT care ( P = 0.04 ) , Rankin score ( P = 0.01 ) , and psychological function ( P < 0.0001 ) but not to age , sex , or stroke severity . There were no significant differences in patient or caregiver satisfaction between the 2 setting s. Conclusions — Better quality of life in patients receiving conventional MDT care may be attributable to improved social functioning and greater attention to higher function and caregiver needs during rehabilitation OBJECTIVE to evaluate whether integrated care pathways improve the processes of care in stroke rehabilitation . DESIGN comparison of processes of care data collected in a r and omized controlled trial . PARTICIPANTS acute stroke patients undergoing rehabilitation r and omized to receive integrated care pathways management ( n=76 ) or conventional multidisciplinary care ( n=76 ) . MEASUREMENTS proportion of patients meeting recommended st and ards for processes of care using a vali date d stroke audit tool . RESULTS integrated care pathways methodology was associated with higher frequency of stroke specific assessment s , notably testing for inattention ( 84 % versus 60 % ; P=0.015 ) and nutritional assessment ( 74 % versus 22 % , P<0.001 ) . Documentation of provision of certain information to patients /carers ( 89 % versus 70 % ; P=0.024 ) and early discharge notification to general practitioners ( 80 % versus 45 % ; P<0.001 ) were also more common in this group . There were no significant differences in the processes of interdisciplinary co-ordination and patient management between the integrated care pathways group and the control group . CONCLUSION integrated care pathways may improve assessment and communication , even in specialist stroke setting BACKGROUND AND PURPOSE Integrated Care Pathway ( ICP ) is an organized , goal -defined , and time-managed plan that has the potential of facilitating timely interdisciplinary coordination , improving discharge planning , and reducing length of hospital stay . METHODS An ICP for stroke rehabilitation based on evidence of best practice , professional st and ards , and existing infrastructure was developed . Its effectiveness was tested in 152 stroke patients undergoing rehabilitation who were r and omized to receive ICP care coordinated by an experienced nurse ( n=76 ) or conventional multidisciplinary care ( n=76 ) . RESULTS The age , sex , premorbid functional ability , and stroke characteristics of the 2 groups were comparable . There were no differences in mortality rates ( 10 [ 13 % ] versus 6 [ 8 % ] ) , institutionalization ( 10 [ 13 % ] versus 16 [ 21 % ] ) , or length of hospital stay ( 50+/-19 versus 45+/-23 days ) between patients receiving ICP or multidisciplinary care . Patients receiving conventional multidisciplinary care improved significantly faster between 4 and 12 weeks ( median change in Barthel Activities of Daily Living Index 6 versus 2 ; P<0.01 ) and had higher Quality of Life scores at 12 weeks ( 65 versus 59 ; P=0.07 ) and 6 months ( 72 versus 63 ; P<0.005 ) . There were no significant differences in the mean duration of physiotherapy ( 42.8+/-41.2 versus 39.4+/-36.4 hours ) or occupational therapy ( 8.5+/-7.5 versus 8.0+/-7.5 hours ) received between the 2 groups . CONCLUSIONS ICP management offered no benefit over conventional multidisciplinary care on a stroke rehabilitation unit . Functional recovery was faster and Quality of Life outcomes better in patients receiving conventional multidisciplinary care Background Across the developed world , we are witnessing an increasing emphasis on the need for more closely coordinated forms of health and social care provision . Integrated care pathways ( ICPs ) have emerged as a response to this aspiration and are believed by many to address the factors which contribute to service integration . ICPs map out a patient 's journey , providing coordination of services for users . They aim to have : ' the right people , doing the right things , in the right order , at the right time , in the right place , with the right outcome ' . The value for ICPs in supporting the delivery of care across organisational boundaries , providing greater consistency in practice , improving service continuity and increasing collaboration has been advocated by many . However , there is little evidence to support their use , and the need for systematic evaluations in order to measure their effectiveness has been widely identified . A recent Cochrane review assessed the effects of ICPs on functional outcome , process of care , quality of life and hospitalisation costs of in patients with acute stroke , but did not specifically focus on service integration or its derivatives . To the best of our knowledge , no such systematic review of the literature exists . Objectives To systematic ally review all high‐ quality studies which have evaluated the impact of care pathway technologies on ' service integration ' and its derivatives in stroke care To examine how elements of service integration are defined in such studies To examine the type of evidence utilised to measure service integration To analyse the weight of evidence used to support cl aims about the effectiveness of ICPs on improving service integration To produce recommendations for ICP developers , users and evaluators . Inclusion criteria Types of participants The review focused on the care of adult patients who had suffered a stroke . It included the full spectrum of services ‐ acute care , rehabilitation and long‐term support ‐ in hospital and community setting s. Types of intervention(s)/phenomena of interest Integrated care pathways were the intervention of interest , defined for the purpose of this review as ' a multidisciplinary tool to improve the quality and efficiency of evidence based care and is used as a communication tool between professionals to manage and st and ardise the outcome orientated care ' . Here ' multidisciplinary ' is taken to refer to the involvement of two or more disciplines . Types of outcomes Service integration ' was the outcome of interest however , this was defined and measured in the selected studies . Types of studies This review was concerned with how ' service integration ' was defined in evaluations of ICPs ; the type of evidence utilised in measuring the impact of the intervention and the weight of evidence to support the effectiveness of care pathway technologies on ' service integration ' . Studies that made an explicit link between ICPs and service integration were included in the review . Evidence generated from r and omised controlled trials , quasi‐experimental , qualitative and health economics research was sought . The search was limited to publications after 1980 , coinciding with the emergence of ICPs in the healthcare context . Assessment for inclusion of foreign papers was based on the English‐ language abstract , where available . These were included only if an English translation was available . Exclusion criteria This review excluded studies that : focused only on a single aspect of stroke care ( e.g. dysphasia ) evaluated ICPs as part of a wider program of service development did not make an explicit link between ICPs and service integration did not meet the definition of ICP utilised for the purpose s of the review focused exclusively on the outcomes of variance analysis Search strategy In order to avoid replication , the Joanna Briggs Institute for Evidence Based Nursing and Midwifery Data base and the Cochrane Library were search ed to establish that no systematic review s existed and none were in progress . A three‐stage search strategy was then used to identify both published and unpublished studies ( see Appendix III ) . Data collection Our search strategy located 2123 papers , of which 39 were retrieved for further evaluation . We critically appraised seven papers , representing five studies . These were all evaluation studies and , as is typical in this field , comprised a range of study design s and data collection methods . Owing to the diversity of the study types included in the review , we developed a single‐ appraisal checklist and data ‐ extraction tool which could be applied to all research design s.32 The tool drew on the Joanna Briggs Institute ( JBI ) appraisal checklists for experimental studies and interpretive and critical research , and also incorporated specific information and issues which were relevant for our purpose s ( see Appendix VI ) . This extends the thinking outlined in Lyne et al.31 in which , drawing on Campbell and Stanley 's classic paper , the case is made for developing an appraisal tool which is applicable to all types of evaluation , irrespective of study design . In assessing the quality of the papers , we were sympathetic to the method ological challenges of evaluating complex interventions such as ICPs . We were also cognisant of the very real constraints in which service evaluations are frequently undertaken in healthcare context s. In accordance with the aims of this particular review , we have included studies , which are method ologically weaker than is typical of many systematic review s because , in our view , in the absence of stronger evidence , they yield useful information . Data synthesis Given the heterogeneity of the included studies , meta‐ analysis and /or qualitative synthesis was not possible . A narrative summary of the study findings is presented . Results ICPs can be effective in ensuring that patients receive relevant clinical interventions and /or assessment s in a timely manner , although these improvements may reflect better documentation rather than actual changes in practice . ICPs can be effective in improving the documentation of rehabilitation goals , documentation of communication with patients , carers ( diagnosis , prognosis and follow‐up arrangements ) and documentation of notification of primary care physicians of discharge . However , this can create additional burdens of work for staff . Early studies of ICP‐managed care in the acute stroke context have demonstrated reduced length of stay without any associated adverse effects on discharge destination , morbidity or mortality . These effects do not reach statistical significance , however , and may reflect wider changes in service provision and a general trend towards reduced length of hospital stay . While later studies in the acute and rehabilitation context s do not reveal any significant reduction in length of stay , they do report greater documented use of certain clinical interventions and assessment s , suggesting that ICPs can be effective in mobilising hospital re sources around the patient . ICPs implemented in the context of acute stroke care can be effective in reducing the occurrence of urinary tract infections , although we do not know whether this can be attributed to improved service integration . ICP management in stroke rehabilitation may not be flexible enough to meet diverse patient needs and can result in insufficient attention to higher‐level functioning and carer needs influencing perceptions of quality of life . ICP management may assist in clarifying role boundaries and a shared underst and ing of the work , but this can result in some members of the disciplinary team perceiving that their contribution is not appropriately reflected in the documentation . There is some evidence that ICPs may be effective in changing professional behaviours in the desired direction where there is scope for improvement , but in situations in which mult
Output:
| On the basis of the evidence considered in the review we suggest that ICPs can be considered as having a multiple role as directing , coordinating , organising , decision-making , and accumulating devices .
In addition , because ICPs accumulate information , it seems reasonable to infer that they also function as ' distributing devices ' by circulating information to users of the pathway , although no definitive evidence is provided in the studies review ed to support this assertion .
Our review indicates that ICPs can have positive effects on service quality and efficiency as a result of their functions .
They are effective in supporting the timely implementation of clinical interventions and the mobilisation of re sources around the patient without incurring additional increases in length of stay .
They also have value in supporting implementation of best practice guidelines and protocol s by translating these into a format which is suitable for daily use by busy health professionals , thereby improving inter and intra-professional consensus and reducing unacceptable variations in clinical practice .
Because they function as accumulating and distributing devices ICPs may also bring about improvements in documentation , which in turn augments their coordinating effects . |
MS211682 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Purpose .To provide a practical quantitative tool for appraising the quality of cost-effectiveness ( CE ) studies . Methods .A committee comprised of health economists selected a set of criteria for the instrument from an item pool . Data collected with a conjoint analysis survey on 120 international health economists were used to estimate weights for each criterion with a r and om effects regression model . To vali date the grading system , a survey was sent to 60 individuals with health economics expertise . Participants first rated the quality of three CE studies on a visual analogue scale , and then evaluated each study using the grading system . Spearman rho and Wilcoxon tests were used to detect convergent validity and analysis of covariance ( ANCOVA ) for discriminant validity . Agreement between the global rating by experts and the grading system was also examined . Results .Sixteen criteria were selected . Their coefficient estimates ranged from 1.2 to 8.9 , with a sum of 93.5 on a 100-point scale . The only insignificant criterion was “ use of subgroup analyses . ” Both convergent validity and discriminant validity of the grading system were shown by the results of the Spearman rho ( correlation coefficient = 0.78 , P < 0.0001 ) , Wilcoxon test ( P = 0.53 ) , and ANCOVA ( F3,146 = 5.97 , P = 0.001 ) . The grading system had good agreement with global rating by experts . Conclusions . The instrument appears to be simple , internally consistent , and valid for measuring the perceived quality of CE studies . Applicability for use in clinical and re source allocation decision-making deserves further study This study evaluated the cost effectiveness of bortezomib in relapsed , refractory myeloma , relative to best supportive care ( BSC ) and thalidomide . Data were derived from the phase 2 pivotal study of bortezomib , a Delphi panel of six myeloma thought leaders , and published literature . Objective assumptions regarding treatment choices and consequences ( response and complications ) , and actual cost data were used . Bortezomib was found to be cost effective relative to BSC and thalidomide . Sensitivity analyses demonstrated the robustness of the results . These data suggest that bortezomib provides a cost-effective treatment option and the best value ( in terms of cost/life-yr gained ) among the currently available therapeutic options for relapsed , refractory myeloma We compared the three arms of the MM-015 r and omized phase III clinical trial [ melphalan and prednisone ( MP ) , MP plus lenalidomide ( MPR ) , and MPR plus lenalidomide maintenance ( MPR-R ) ] to determine whether the addition of lenalidomide maintenance therapy for primary treatment of multiple myeloma is cost-effective . We used progression-free survival and adverse event data from the MM-015 study for the analysis . Two novel measures of cost-effectiveness termed the Average Cumulative Cost per Patient ( ACCP ) and the Average Cumulative Cost per Progression-Free Survivor ( ACCPFS ) were developed for the purpose of this analysis . The ACCP of MP was USD 18,218 , compared to USD 167,862 for MPR and USD 309,173 for MPR-R. The ACCPFS was highest with MPR at USD 1,555,443 , while MP was USD 313,592 and MPR-R was USD 690,111 . MPR-R is superior to MPR in terms of preventing the first progression after initial therapy . However , the addition of lenalidomide to MP in the induction and also in the maintenance setting leads to significant costs High dose chemotherapy with autologous stem cell transplantation ( ASCT ) improves outcomes in patients 65 years of age or less with multiple myeloma . Survival and costs in a cohort of 16 patients who received melphalan and prednisone as part of a clinical trial were compared with those of 36 patients referred to our centre for consideration of ASCT . In the transplant group , survival and costs were extrapolated to match the period of observation in the melphalan and prednisone group . Patient-specific and average costs were calculated from the perspective of the Ontario Ministry of Health . Costs and survival were varied by 50 % in the sensitivity analysis . Transplantation improved life expectancy by 19.3 months with a cost difference of $ 30,517 Canadian . The incremental cost-effectiveness of transplantation compared with melphalan and prednisone was $ 25,710 Canadian per life-year gained when additional pamidronate and follow-up costs were considered . Discounting costs and survival at 3 and 5 % did not result in important differences . The sensitivity analysis result ed in best and worse case scenarios for transplantation compared with melphalan and prednisone of $ 13,049 and $ 63,954 per life-year gained respectively . In comparison with melphalan and prednisone , ASCT appears to be cost-effective in patients 65 years old or younger with myeloma The outlook for transplant-ineligible multiple myeloma patients has improved enormously over recent years with the incorporation of new agents into st and ard regimens . Novel regimens combine melphalan and prednisone ( MP ) with bortezomib ( VMP ) , with thalidomide ( MPT ) , and with lenalidomide with ( MPR-R ) and without ( MPR ) lenalidomide maintenance . The efficacy , safety , and cost-effectiveness of these regimens have not yet been compared ; therefore , we conducted a pharmacoeconomic analysis using data from r and omized controlled trials versus MP . Using a Markov model developed from a U.S. payer 's perspective , we compared VMP with MPT and MPR-R over a lifetime horizon . MPT and MPR-R were chosen because , like VMP , they are superior to MP in response and outcomes . Data from the Velcade as Initial St and ard Therapy in Multiple Myeloma ( VISTA ; VMP ) , Intergroupe Francophone du Myelome ( IFM ) 99 - 06 ( MPT ) , and MM-015 ( MPR-R ) trials were used . The IFM 99 - 06 study was selected because of the superior activity in this study compared with other MPT studies . Using patient-level ( VMP ) and published ( MPT , MPR-R ) data , we estimated the health-state transition and adverse event probabilities for each regimen , related costs , and state-specific utility estimates . Costs ( in 2010 U.S. dollars ) and health outcomes were discounted at 3 % . Discounted lifetime direct medical costs were lowest with VMP at $ 119,102 . MPT cost $ 142,452 whereas MPR-R cost $ 248,358 . Incremental cost-effectiveness ratio calculations projected that VMP would confer cost savings and better health outcomes relative to MPT and MPR-R. We conclude that VMP is highly likely to be cost-effective compared with MP , MPT , and
Output:
| For transplant-eligible MM patients , transplant is a cost-effective first-line treatment .
In the second-line setting , it is unclear which novel agent-based regimen is most cost effective , but bortezomib-based regimens , lenalidomide plus dexamethasone , and pomalidomide plus dexamethasone were each cost effective compared with dexamethasone alone |
MS211683 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Hypothermia therapy improves survival and the neurologic outcome in animal models of traumatic brain injury . However , the effect of hypothermia therapy on the neurologic outcome and mortality among children who have severe traumatic brain injury is unknown . METHODS In a multicenter , international trial , we r and omly assigned children with severe traumatic brain injury to either hypothermia therapy ( 32.5 degrees C for 24 hours ) initiated within 8 hours after injury or to normothermia ( 37.0 degrees C ) . The primary outcome was the proportion of children who had an unfavorable outcome ( i.e. , severe disability , persistent vegetative state , or death ) , as assessed on the basis of the Pediatric Cerebral Performance Category score at 6 months . RESULTS A total of 225 children were r and omly assigned to the hypothermia group or the normothermia group ; the mean temperatures achieved in the two groups were 33.1+/-1.2 degrees C and 36.9+/-0.5 degrees C , respectively . At 6 months , 31 % of the patients in the hypothermia group , as compared with 22 % of the patients in the normothermia group , had an unfavorable outcome ( relative risk , 1.41 ; 95 % confidence interval [ CI ] , 0.89 to 2.22 ; P=0.14 ) . There were 23 deaths ( 21 % ) in the hypothermia group and 14 deaths ( 12 % ) in the normothermia group ( relative risk , 1.40 ; 95 % CI , 0.90 to 2.27 ; P=0.06 ) . There was more hypotension ( P=0.047 ) and more vasoactive agents were administered ( P<0.001 ) in the hypothermia group during the rewarming period than in the normothermia group . Lengths of stay in the intensive care unit and in the hospital and other adverse events were similar in the two groups . CONCLUSIONS In children with severe traumatic brain injury , hypothermia therapy that is initiated within 8 hours after injury and continued for 24 hours does not improve the neurologic outcome and may increase mortality . ( Current Controlled Trials number , IS RCT N77393684 [ controlled-trials.com ] . ) INTRODUCTION Traumatic brain injury ( TBI ) is a leading cause of death and disability worldwide . Prophylactic hypothermia is effective in laboratory models , but clinical studies to date have been inconclusive , partly because of method ological limitations . Our Prophylactic Hypothermia Trial to Lessen Traumatic Brain Injury ( POLAR ) r and omised controlled trial is currently underway comparing early , sustained hypothermia versus st and ard care in patients with severe TBI . We describe our study protocol and the challenges in conducting prophylactic hypothermia research in TBI . DESIGN We aim to r and omise 500 patients to either prophylactic 33 ° C hypothermia initiated within 3 hours of injury and continued for at least 72 hours , or st and ard normothermic management . Patients will be enrolled by paramedic services in the prehospital setting , or by emergency department staff at participating sites in Australia , New Zeal and and Europe . The primary outcome will be the eight-level extended Glasgow outcome scale ( GOSE ) , dichotomised to favourable and unfavourable outcomes at 6 months after injury . Secondary outcomes will include mortality at hospital discharge and at 6 months , ordinal analyses of 6-month GOSE outcomes , quality of life with health economic evaluations and the differential proportion of adverse events . We will predefine subgroup and interaction analyses . DISCUSSION After a run-in phase , recruitment for our main study began in December 2010 . When the study is completed , we aim to provide evidence on the efficacy of prophylactic hypothermia in TBI to guide clinicians in their management of this devastating condition BACKGROUND The inconsistent effect of hypothermia treatment on severe brain injury in previous trials might be because hypothermia was induced too late after injury . We aim ed to assess whether very early induction of hypothermia improves outcome in patients with severe brain injury . METHODS The National Acute Brain Injury Study : Hypothermia II ( NABIS : H II ) was a r and omised , multicentre clinical trial of patients with severe brain injury who were enrolled within 2·5 h of injury at six sites in the USA and Canada . Patients with non-penetrating brain injury who were 16 - 45 years old and were not responsive to instructions were r and omly assigned ( 1:1 ) by a r and om number generator to hypothermia or normothermia . Patients r and omly assigned to hypothermia were cooled to 35 ° C until their trauma assessment was completed . Patients who had none of a second set of exclusion criteria were either cooled to 33 ° C for 48 h and then gradually rewarmed or treated at normothermia , depending upon their initial treatment assignment . Investigators who assessed the outcome measures were masked to treatment allocation . The primary outcome was the Glasgow outcome scale score at 6 months . Analysis was by modified intention to treat . This trial is registered with Clinical Trials.gov , NCT00178711 . FINDINGS Enrolment occurred from December , 2005 , to June , 2009 , when the trial was terminated for futility . Follow-up was from June , 2006 , to December , 2009 . 232 patients were initially r and omised a mean of 1·6 h ( SD 0·5 ) after injury : 119 to hypothermia and 113 to normothermia . 97 patients ( 52 in the hypothermia group and 45 in the normothermia group ) did not meet any of the second set of exclusion criteria . The mean time to 35 ° C for the 52 patients in the hypothermia group was 2·6 h ( SD 1·2 ) and to 33 ° C was 4·4 h ( 1·5 ) . Outcome was poor ( severe disability , vegetative state , or death ) in 31 of 52 patients in the hypothermia group and 25 of 56 in the normothermia group ( relative risk [ RR ] 1·08 , 95 % CI 0·76 - 1·53 ; p=0·67 ) . 12 patients in the hypothermia group died compared with eight in the normothermia group ( RR 1·30 , 95 % CI 0·58 - 2·52 ; p=0·52 ) . INTERPRETATION This trial did not confirm the utility of hypothermia as a primary neuroprotective strategy in patients with severe traumatic brain injury Objective : Severe head trauma and /or severe hypothermia ( ≤32 ° C ) can cause cardiac arrhythmias . Effect of moderate hypothermia ( 32 - 33 ° C ) on cardiac arrhythmias in children after severe traumatic brain injury is not well characterized . The objective is to determine the effect of moderate and short-term ( 24 hrs ) hypothermia therapy on the incidence and severity of cardiac arrhythmias in children with severe traumatic brain injury compared with normothermic control subject using a 24-hr Holter recording . Design : Prospect i ve ancillary study of a multicenter r and omized , controlled clinical trial . Setting : A Canadian university-affiliated pediatric intensive care unit in a level III trauma center . Patients : Patients < 18 yrs with severe traumatic brain injury . Interventions : Holter recording during moderate hypothermia ( HYPO group ; esophageal temperature 32 - 33 ° C ) or normothermia ( NORMO group ; 36.5 - 37.5 ° C ) induced for 24 hrs started within 8 hrs after a severe traumatic brain injury . Measurements and Main Results : Sixteen patients who had a median age of 12.7 yrs ( range , 7.2 - 17.0 yrs ) were enrolled . The time from the injury to the start of the cooling process was 7.3 hrs ( range , 6.6 - 7.8 hrs ) . The temperature when Holter recording began was 32.9 ° C ( range , 31.6 - 34.4 ° C ) in the HYPO group . Overall , 44 % of all patients ( seven of 16 patients ) had arrhythmias ( two of nine in the NORMO group and five of seven in the HYPO group , p = .13 ) . The most frequent arrhythmias were isolated premature atrial contractions . Hypothermic patients had lower heart rates than normothermic patients ( p = .01 ) , but none had a severe bradycardia . In the NORMO group , one patient had accelerated junctional rhythm associated with hypotension . In the HYPO group , one patient had nonsustained monomorphic ventricular tachycardia . Conclusions : Arrhythmias are frequent in severe pediatric traumatic brain injury . Further studies are needed to characterize the epidemiology and clinical impact of arrhythmias associated with severe pediatric head trauma and moderate hypothermia Background : Induced hypothermia for treatment of traumatic brain injury is controversial . Since many pathways involved in the pathophysiology of secondary brain injury are temperature dependent , regional brain hypothermia is thought capable to mitigate those processes . The objectives of this study are to assess the therapeutic effects and complications of regional brain cooling in severe head injury with Glasgow coma scale ( GCS ) 6 - 7 . Material s and Methods : A prospect i ve r and omized controlled pilot study involving patients with severe traumatic brain injury with GCS 6 and 7 who required decompressive craniectomy . Patients were r and omized into two groups : Cooling and no cooling . For the cooling group , analysis was made by dividing the group into mild and deep cooling . Brain was cooled by irrigating the brain continuously with cold Hartmann solution for 24 - 48 h. Main outcome assessment s were a dichotomized Glasgow outcome score ( GOS ) at 6 months posttrauma . Results : A total of 32 patients were recruited . The cooling-treated patients did better than no cooling . There were 63.2 % of patients in cooling group attained good GOS at 6 months compared to only 15.4 % in noncooling group ( P = 0.007 ) . Interestingly , the analysis at 6 months post-trauma disclosed mild-cooling-treated patients did better than no cooling ( 70 % vs. 15.4 % attained good GOS , P = 0.013 ) and apparently , the deep-cooling-treated patients failed to be better than either no cooling ( P = 0.074 ) or mild cooling group ( P = 0.650 ) . Conclusion : Data from this pilot study imply direct regional brain hypothermia appears safe , feasible and maybe beneficial in treating severely head-injured patients Purpose : To evaluate the efficacy and safety of mild induced hypothermia for intracranial hypertension in patients with traumatic brain injury after decompressive craniectomy . Methods : A total of 60 adults with intracranial pressure ( ICP ) of more than 20 mm Hg after decompressive craniectomy were r and omly assigned to st and ard care ( control group ) or hypothermia ( 32 ° C‐35 ° C ) plus st and ard care . Then , ICP , cerebral perfusion pressure , Glasgow Outcome Scale score , and complications were assessed . Results : There was a significant difference in ICP and cerebral perfusion pressure between the 2 groups . Favorable outcomes occurred in 12 ( 40.0 % ) and 7 ( 36.5 % ) patients in the hypothermia and control groups , respectively ( P = .267 ) . Kaplan‐Meier curves revealed a marked difference in survival between the hypothermia and control groups ( P = .032 ) . There were significant differences in pulmonary infection and electrolyte disorders between the hypothermia and control groups ( P = .038 and .033 , respectively ) . Conclusion : Mild induced hypothermia can reduce intracranial hypertension after decompressive craniectomy , decreasing patient mortality . Hypothermia should be considered one of the main treatments for intracranial hypertension after decompressive craniectomy in patients with traumatic brain injury . HighlightsThis is a r and omized controlled trial research .Mild induced hypothermia therapeutics can reduce the intracranial hypertension after the decompressive craniectomy and can reduce the mortality of the patients Rationale Intracerebral hemorrhage causes 15 % of strokes annually in the United States , and there is currently no effective therapy . Aims and hypothesis This is a clinical trial design ed to study the safety , feasibility , and efficacy of a protocol of targeted temperature management to moderate hypothermia in intracerebral hemorrhage patients . Methods The targeted temperature management after intracerebral hemorrhage trial is a prospect i ve , single-center , interventional , r and omized , parallel , two-arm ( 1:1 ) phase-II clinical trial with blinded end-point ascertainment . Intracerebral hemorrhage patients will be r and omized within 18 h of symptom onset to either 72 h of targeted temperature management to moderate hypothermia ( 32–34 ° C ) followed by a controlled rewarming at of 0·05–0·1 ° C per hour or 72 h of targeted temperature management to normothermia ( 36–37 ° C ) using endovascular or surface cooling . Outcomes The primary outcome is the development of serious adverse events possibly and probably related to treatment . Secondary outcomes include in-hospital neurological deterioration between day 0–7 , in-hospital mortality , functional outcome measured by the modified Rankin scale at dis
Output:
| Despite a large number studies , there remains no high- quality evidence that hypothermia is beneficial in the treatment of people with TBI .
Further research , which is method ologically robust , is required in this field to establish the effect of hypothermia for people with TBI |
MS211684 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To compare live birth rates after fresh embryo transfer ( ET ) and cumulative ongoing pregnancy rates after fresh ET and frozen-thawed ( ET ) between continents and overall after one treatment cycle with corifollitropin alfa or recombinant FSH . DESIGN Double-blind , multicenter , r and omized controlled trial . SETTING Fourteen centers in North America ( NA ) ; 20 in Europe ( EU ) . PATIENT(S ) 804 NA patients and 702 EU patients . INTERVENTION(S ) Patients > 60 kg received a single dose of corifollitropin alfa or daily rFSH for the first 7 days of controlled ovarian stimulation . MAIN OUTCOME MEASURE(S ) Live birth rates . RESULT ( S ) Within each continent no differences were noted between the two treatment groups ; however , between continents , the cumulative ongoing pregnancy rate and live birth rate were considerably higher in NA than in EU . The live birth rate in NA was 39.2 % in both treatment groups compared with 31.5 % and 28.8 % in EU after corifollitropin alfa and rFSH treatment , respectively . Considering the number of embryos transferred , the live birth rate per ET was still higher in NA than in EU ( 42.7 % v.s 36.8 % with corifollitropin alfa and 41.6 % vs. 30.9 % with rFSH ) . Overall live birth rates after fresh ET were 35.6 % and 34.4 % ( estimated difference 1.1 % [ 95 % confidence interval -3.7 - 5.8 ] ) , and the estimated cumulative live birth rates were 43.4 % and 41.3 % with corifollitropin alfa and rFSH , respectively . CONCLUSION ( S ) Live birth rates and cumulative pregnancy rates were higher in NA than in EU after treatment with either corifollitropin alfa or daily rFSH ; both treatment protocol s provided equal success rates . CLINICAL TRIALS.GOV IDENTIFIERS : NCT00703014 and NCT00702273 STUDY QUESTION Is treatment with corifollitropin alfa , a new recombinant gonadotrophin with sustained follicle-stimulating activity , safe in terms of perinatal complications and birth defects in infants conceived following corifollitropin alfa treatment for contolled ovarian stimulation ( COS ) ? SUMMARY ANSWER In terms of neonatal outcome and risk of malformations , treatment with a single dose of corifollitropin alfa during COS is as safe as treatment with daily recombinant FSH ( rFSH ) . WHAT IS KNOWN AND WHAT THIS PAPER ADDS This is the first pooled analysis of individual safety data in terms of neonatal outcome and major and minor congenital malformations collected following intervention trials of corifollitropin alfa . DESIGN Pregnancy and follow-up studies were conducted prospect ively and data were collected from all Phase II and III trials with corifollitropin alfa intervention , including two comparative r and omized controlled trials ( RCTs ) in which patients received either a single dose of corifollitropin alfa or daily rFSH for the first 7 days of COS . Patients with ongoing pregnancies at 10 weeks after embryo transfer were followed up to labour and the health of the offspring was assessed up to 4 - 12 weeks after birth . PARTICIPANTS AND SETTING Following corifollitropin alfa treatment prior to IVF or ICSI , the health of 677 pregnant women , 838 fetuses and 806 live born infants was evaluated . MAIN RESULTS AND THE ROLE OF CHANCE Among 440 fetuses in the corifollitropin alfa arm and 381 fetuses in the rFSH arm of the two RCTs , there were 424 ( 96.4 % ) and 370 ( 98.7 % ) live births , respectively . Neonatal characteristics , the frequency of premature births and the incidence of infant adverse events were similar in both treatment arms . The overall incidence of any congenital malformations in live born infants was 16.3 and 17.0 % , with major malformation rates of 4.0 and 5.4 % in the corifollitropin alfa and rFSH groups , respectively [ odds ratio ( OR ) for major malformations , 0.71 ; 95 % confidence interval , 0.36 - 1.38 ] . From 838 fetuses assessed in all corifollitropin alfa intervention trials , there were 806 ( 96.2 % ) live births with a major malformation rate of 4.5 % in live born infants . BIAS , CONFOUNDING AND OTHER REASONS FOR CAUTION Both RCTs had a double-blind and active-controlled design and the adjudication of congenital malformations was also performed in a blinded fashion . As the total number of major malformations was limited ( 37 ) , the confidence interval around the OR was rather wide . GENERALISABILITY TO OTHER POPULATION S : The similarity of corifollitropin alfa and rFSH with respect to the incidence of congenital malformations was consistent across the RCTs and pregnancy type ( singleton , multiple ) . This suggests that this similarity could hold in general . Overall incidences , however , may depend on the definitions of malformations and rules to adjudicate these events as major or minor A single injection of corifollitropin alfa can replace seven daily injections of recombinant FSH ( rFSH ) using a gonadotrophin-releasing hormone antagonist protocol in ovarian stimulation prior to IVF or intracytoplasmic sperm injection . This double-blind r and omized controlled trial assessed the pharmacokinetics and pharmacodynamics of 150μg corifollitropin alfa versus daily 200IU rFSH in 1509 patients . Comparative analyses were performed on serum concentrations of FSH immunoreactivity ( pharmacokinetics ) , and the number and size of growing follicles , and inhibin B and oestradiol concentrations as biomarkers of ovarian response ( pharmacodynamics ) . The rate of follicular development was similar in both treatment groups . By stimulation day 8 , 33 % of patients treated with corifollitropin alfa reached the criterion for human chorionic gonadotrophin ( HCG ) injection . The number of follicles ⩾11 mm was slightly higher after corifollitropin alfa compared with daily rFSH at stimulation day 8 ( difference , 1.2 ; 95 % confidence interval ( CI ) 0.5 - 1.8 ; P<0.01 ) and on the day of HCG injection ( difference , 2.1 ; 95 % CI 1.4 - 2.8 ; P<0.01 ) . The rise of inhibin B and oestradiol concentrations was similar in both treatment groups . Although the pharmacokinetics of corifollitropin alfa and rFSH are quite different their pharmacodynamic profiles at the dosages used are similar . A single injection of corifollitropin alfa can replace seven daily injections of recombinant FSH ( rFSH ) using a gonadotrophin-releasing hormone antagonist protocol in ovarian stimulation prior to IVF or intracytoplasmic sperm injection . The objective of this study was to compare the pharmacokinetics and pharmacodynamics of corifollitropin alfa versus daily rFSH . A total of 1509 patients were r and omized in a double-blind , controlled trial to either a single injection of 150μg corifollitropin alfa or to daily injections of 200IU rFSH for the first 7 days of ovarian stimulation . Serum levels of FSH immunoreactivity were analysed ( pharmacokinetic analysis ) , together with the number and size of growing follicles and serum inhibin B and oestradiol concentrations as biomarkers of the ovarian response ( pharmacodynamic analysis ) . Serum FSH immunoreactivity levels were higher up to stimulation day 5 for corifollitropin alfa compared with the daily rFSH regimen but were similar from day 8 onwards , when patients started rFSH if the criteria for human chorionic gonadotrophin were not yet reached . Corifollitropin alfa treatment result ed in a similar growth rate of follicles though a slightly higher number of follicles were recruited compared with daily rFSH . It is concluded that the pharmacokinetics of corifollitropin alfa and rFSH are quite different but their induced pharmacodynamic effects at the dosages used are similar BACKGROUND This study primarily investigated the dose-response relationship of corifollitropin alfa to initiate multifollicular development for the first 7 days of controlled ovarian stimulation ( COS ) . METHODS Women aged 20 - 39 years undergoing COS for in vitro fertilization or intracytoplasmic sperm injection were r and omized to a single dose of corifollitropin alfa 60 , 120 or 180 microg , or daily injections of 150 IU recombinant follicle-stimulating hormone ( rFSH ) . Patients treated with corifollitropin alfa started fixed daily treatment with 150 IU rFSH on stimulation Day 8 . Patients received a GnRH antagonist ( ganirelix 0.25 mg/day ) from stimulation Day 5 until the day of human chorionic gonadotrophin . RESULTS Pharmacokinetics of corifollitropin alfa were dose-proportional . The main reason for not having embryo transfer was insufficient ovarian response in 30.8 , 2.6 , 3.8 and 7.4 % of patients in the corifollitropin alfa 60 , 120 , 180 microg and rFSH groups , respectively . On Day 8 , the mean ( st and ard deviation ) number of follicles > or=11 mm was 6.8 ( 4.4 ) , 10.1 ( 6.1 ) and 12.8 ( 7.5 ) , respectively . The number of cumulus-oocyte complexes retrieved showed a clear dose-response relationship ( P < 0.0001 ) , being 5.2 ( 5.5 ) , 10.3 ( 6.3 ) and 12.5 ( 8.0 ) in the three dose groups , respectively . CONCLUSIONS A single injection of corifollitropin alfa induces dose-related increase in multifollicular development and in the number of retrieved oocytes . The optimal dose for a 1-week interval is higher than 60 microg and lower than 180 microg and will be selected based on modelling and simulation taking into account insufficient stimulation as well as overstimulation . Clinical Trials gov : NCT00598208 Background We sought to determine the impact of treatment flexibility on clinical outcomes in either a corifollitropin alfa or recombinant follicle-stimulating hormone ( rFSH ) protocol . Methods Post hoc analysis of a prospect i ve , multicenter , r and omized , double-blind , double-dummy non-inferiority clinical trial ( Engage ) . Efficacy outcomes were assessed on patients from the Engage trial who started treatment on menstrual cycle day 2 versus menstrual cycle day 3 , patients who received rFSH step-down or fixed-dose rFSH , patients who received rFSH on the day of human chorionic gonadotropin ( hCG ) compared with those who did not , and patients who received hCG when the criterion was reached versus those with a 1-day delay . Results The effect of each of the treatment flexibility options on ongoing pregnancy rate was not significant . The estimated difference ( 95 % confidence interval ) in ongoing pregnancy rate was -4.3 % ( -9.4 % , 0.8 % ) for patients who started ovarian stimulation on cycle day 2 versus day 3 , 1.8 % ( -4.1 % , 7.6 % ) for patients who received hCG on the day the hCG criterion was met versus 1 day after , 3.2 % ( -2.1 % , 8.6 % ) for patients who received rFSH on the day of hCG administration versus those who did not , and -5.8 % ( -13.0 % , 1.4 % ) for patients who received a reduced versus fixed-dose of rFSH from day 8 . Conclusions Treatment flexibility of ovarian stimulation does not substantially affect the clinical outcome in patients ’ treatment following initiation of ovarian stimulation with either corifollitropin alfa or with daily rFSH in a gonadotropin-releasing hormone antagonist protocol .Trial registration Trial was registered under Clinical Trials.gov identifier NCT00696800 BACKGROUND One injection of corifollitropin alfa replaces the first seven daily FSH injections in controlled ovarian stimulation ( COS ) cycles . Repeated treatment with therapeutic proteins may cause immune responses or hypersensitivity reactions . We assessed the immunogenicity and safety of corifollitropin alfa treatment in up to three COS cycles . METHODS In this multicentre , phase III uncontrolled trial , patients ( > 60 kg ) started treatment with one injection of 150 µg corifollitropin alfa on cycle Day 2 or 3 of menses and 0.25 mg ganielix on stimulation Day 5 or 6 . Primary outcome measures were antibody formation against corifollitropin alfa ( using highly sensitive radioimmunopreci
Output:
| The use of a medium dose ( 150 to 180 μg ) of long-acting FSH is a safe treatment option and equally effective compared to daily FSH in women with unexplained subfertility .
There was evidence of reduced live birth rate in women receiving a low dose ( 60 to 120 μg ) of long-acting FSH compared to daily FSH . |
MS211685 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Venous stasis caused by immobility is an important risk factor for deep vein thrombosis following surgery and lower limb trauma , in bed-ridden medical patients , and in high-risk long distance air travelers . A safe and convenient method for reducing venous stasis would be useful in patients while in hospital and after discharge during their rehabilitation . SUBJECTS AND METHODS 49 healthy subjects aged 51 - 76 were seated for 4 hours during which they received mild electrical stimulation of the calf , or sole of the foot ( plantar muscles ) . Popliteal and femoral venous blood flow velocities were measured via doppler ultrasound . The non-stimulated lower extremity served as the simultaneous control . Subjects completed a question naire regarding their acceptance and tolerance of the electrical stimulation . RESULTS There was a significant increase in venous femoral and popliteal blood flow for both calf ( p < 0.035 , p < 0.003 ) , and plantar muscles ( p < 0.0001 , p < 0.009 ) on the stimulated side compared to the unstimulated side . The magnitude of the effect was similar for calf and plantar muscle stimulation . Subjects did not find the experience uncomfortable , and would use an electrical stimulator if told by their physician that they were at risk for developing blood clots . CONCLUSIONS Mild electrical stimulation of the feet , as well as the calf , is a safe effective and convenient method for counteracting venous stasis and therefore has the potential to reduce the risk of deep vein thrombosis and pulmonary embolism for subjects who are immobilized Bed rest poses an increased risk factor for a potentially fatal venous thromboembolism ( VTE ) . Lack of activation of the calf muscle pump during this resting period gives rise to venous stasis which may lead to deep vein thrombosis ( DVT ) development . Our aim was to investigate the effects that 4h of bed rest have on the lower limb hemodynamics of healthy subjects and to what extent electrically elicited contractions of the calf muscles can alleviate these effects . Outcome variables included popliteal vein blood flow and heart rate . Primary results indicated that the resting group experienced a significant decline in popliteal venous blood flow of approximately 47 % with approximately 13 % decrease in heart rate . The stimulated groups maintained a significantly higher venous blood flow and heart rate . Volume flow in the contralateral limb remained constant throughout the study and was comparable to that of the stimulated limb 's recovery flow . The results suggest that even short periods of bed rest can significantly reduce lower limb blood flow which could have implication s for DVT development . Electrically elicited calf muscle contractions significantly improve lower limb blood flow and can alleviate some debilitating effects of bed rest Background Deep vein thrombosis ( DVT ) is a major complication in critical care . There are various methods of prophylaxis , but none of them fully prevent DVT , and each method has adverse effects . Electrical muscle stimulation ( EMS ) could be a new effective approach to prevent DVT in intensive care unit ( ICU ) patients . We hypothesized that EMS increases the venous flow of the lower limbs and has a prophylactic effect against the formation of DVT . Methods This study included 26 patients admitted to a single ICU . We enrolled patients who could not move themselves due to spinal cord injury , head injury , central nervous system abnormalities , and sedation for mechanical ventilation . The patients were r and omly allocated to either the EMS group or the control group . Patients in the EMS group received 30-min sessions of EMS applied to the bilateral lower extremities on arbitrary days within 14 days after admission . The control patients received no EMS . The peak flow velocity and diameter of the popliteal vein ( Pop . V ) and common femoral vein ( CFV ) were measured by ultrasound and then the volumes of venous flow were calculated using a formula . Results There were no statistically significant differences in patient characteristics between the two groups except for the mortality rate . In the EMS group , the median and interquartile range ( IQR , 25th–75th percentile ) of velocities of the Pop . V and CFV were higher during EMS compared with at rest : 10.6 ( 8.0–14.8 ) vs 24.5 ( 15.1–37.8 ) cm/s and 17.0 ( 12.3–23.8 ) vs 24.3 ( 17.0–33.0 ) cm/s , respectively ( p < 0.05 ) . The median ( IQR ) of volumes of venous flow of the Pop . V and CFV at rest and during EMS were 4.2 ( 2.7–7.2 ) vs 8.6 ( 5.4–16.1 ) cm3/s and 12.9 ( 9.7–21.4 ) vs 20.8 ( 12.3–34.1 ) cm3/s , respectively ( p < 0.05 ) . There were no major complications related to EMS . Conclusions EMS increased the venous flow of the lower limbs . EMS could be one potential method for venous thromboprophylaxis . Trial registration Background : Lower deep venous thrombosis ( DVT ) is one of the major complications of patients with tumors or patients undergoing major surgery . Electrical acupoint stimulation , an established technique of traditional Chinese medicine ( TCM ) , can be well combined with Western medicine to reduce the incidence of postoperative DVT , especially in elderly patients . Objective : The objectives of this study were to assess the efficiency of electrical acupoint stimulation in the prevention of postsurgery DVT in elderly patients with gastrointestinal malignant tumors and to vali date an effective and safe nursing approach that integrates TCM and Western medicine . Methods : A total of 120 patients ( none aged < 60 years ) who underwent malignant gastrointestinal tumor surgery between July 2005 and May 2007 were r and omly divided into 3 groups : routine nursing group ( group C1 ) , graduated compression stockings group ( group C2 ) , and electrical acupoint stimulation group ( group T ) . Hemorheological parameters ( blood viscosity , etc ) were measured and compared before and after surgery . Results : Compared with groups C1 and C2 , group T showed a significant difference in blood viscosity and blood flow velocity ( P < .05 ) . However , there were no statistical differences among groups C1 , C2 , and T in other hemorheological parameters . Conclusions : By speeding up the blood flow in patients ’ lower limbs , electrical acupoint stimulation showed a great potential to prevent symptomless DVT in elderly patients after malignant gastrointestinal tumor surgery . Implication s for Practice : Western medical care combined with TCM can reduce the occurrence of lower DVT in elderly patients suffering from gastrointestinal cancer . This approach may help nurses to plan effective care for elderly patients BACKGROUND Compression devices have been shown to prevent thromboembolic disease . However , the pressures generated may not be the same as the ones recommended by the manufacturer . The purpose of this study is to investigate a new sequential compression device with feedback to maintain optimal therapy , and to determine whether therapy is improved with this new device . PATIENTS AND METHOD A series of 50 patients undergoing elective total hip arthroplasty at a major tertiary-care hospital with a special interest in joint replacement were enrolled prospect ively . In addition to pharmacological prophylaxis for thromboembolic disease , all patients received compression from a modified device . Maximum pressures generated and the rate of pressure rise in each of the 3 compartments within the device sleeves were measured and the results compared with data from historical controls . RESULTS We considered therapy to be ideal when in a particular compression cycle all chambers of both right and left sleeves reach within 10 % of their target pressures at within 10 % of their target pressure rise rates . The average patient received this ideal therapy 88 % of the time that the new trial sequential compression device was operating . This represents a dramatic improvement over previous devices . CONCLUSIONS The new device allows dramatically improved pressures within the device because of a feedback loop that allows dynamic control of each chamber 's pressure . Improved consistency of delivery should make it easier to accurately assess the true benefits of mechanical prophylaxis with a sequential compression device Background Patients post total hip arthroplasty ( THA ) remain at high risk of developing Deep Vein Thrombosis ( DVT ) during the recovery period following surgery despite the availability of effective pharmacological and mechanical prophylactic methods . The use of calf muscle neuromuscular electrical stimulation ( NMES ) during the hospitalised recovery period on this patient group may be effective at preventing DVT . However , the haemodynamic effectiveness and comfort characteristics of NMES in post-THA patients immediately following surgery have yet to be established . Methods The popliteal veins of 11 patients , who had undergone unilateral total hip replacement surgery on the day previous to the study , were measured using Doppler ultrasound during a 4 hour neuromuscular electrical stimulation ( NMES ) session of the calf muscles . The effect of calf muscle NMES on peak venous velocity , mean venous velocity and volume flow were compared to resting values . Comfort was assessed using a 100 mm non-hatched visual analogue scale taken before application of NMES , once NMES was initiated and before NMES was withdrawn . Results In the operated limb NMES produced increases in peak venous velocity of 99 % compared to resting . Mean velocity increased by 178 % compared to resting and volume flow increased by 159 % compared to resting . In the un-operated limb , peak venous velocity increased by 288 % , mean velocity increased by 354 % and volume flow increased by 614 % compared to basal flow ( p<0.05 in all cases ) . There were no significant differences observed between the VAS scores taken before the application of NMES , once NMES was initiated and before NMES was withdrawn ( p=.211 ) . Conclusions NMES produces a beneficial hemodynamic response in patients in the early post-operative period following orthopaedic surgery . This patient group found extended periods of calf-muscle NMES tolerable . Trial registration Clinical Trials.gov The aim of this study was to examine the effects of the sitting posture on the lower limb venous flow and to explore the beneficial effects of neuromuscular electrical stimulation ( NMES ) and an ottoman-type seat on the venous flow . Healthy adult volunteers without a history of lower limb surgery or thromboembolism were recruited , and the flow velocity , cross-sectional area , and flow volume of the popliteal vein were measured using Doppler ultrasound . A posture change from the prone position to the sitting position on the ottoman-type seat decreased the flow velocity and increased the cross-sectional area of the popliteal vein , and the flow volume was not altered over 120 min . The flow velocity was further decreased , and the cross-sectional area was further increased by subjects sitting on a regular driving seat when compared with the values obtained with an ottoman-type seat . The popliteal flow velocity in the NMES leg was significantly higher than in the non-NMES leg throughout the 120-min testing in the sitting position , but no difference in the cross-sectional area was found between the NMES and the non-NMES legs . Thus lower limb venous stasis elicited by the sitting posture was improved by the ottoman-type seat and NMES AIM The aim of this pilot study was to evaluate the potential effect of electrical calf muscle stimulation ( EMS ) in the prevention of postoperative deep vein thrombosis ( DVT ) in high risk patients and to assess efficacy and safety of EMS in patients with calf DVT . METHODS This was a prospect i ve non-r and omized controlled study involving 80 patients over the age of 40 having major surgery ( 44 abdominal and 36 cranial or spinal surgery ; duration more than 60 min under general anesthesia ) . Patients were divided into 2 comparable groups : main ( N.=40 ) and control ( N.=40 ) . In both groups graduated middle stretch compression b and age with compression level 20 - 40 mmHg was applied and low dose unfractioned heparin ( LDUH ) injections ( 5000 U s.c . 3 t.i.d ) were started on 1st or 2 - 5th day after surgery and continued until discharge . The time of starting LDUH was comparable in both groups . In addition , electrical calf muscle stimulation ( EMS ) with Veinoplus device was performed for not less than 5 periods of 20 minutes per day ( total > 100 minutes ) in the main group . Control of venous patency was performed with duplex ultrasound obligatory at baseline ( first 24 h after surgery ) and then every 3 days until discharge . RESULTS The incidence of DVT was 2.5 % in the main group and 25 % in the control group ( P=0.007 ) . In patients without DVT at baseline it was 3 % versus 21 % ( P=0.025 ) . Patients with baseline thrombosis who underwent EMS did not have any new cases of DVT and PE , while in patients without EMS thrombosis progression was observed in 43 % cases also without pulmonary embolism ( not significant ) . CONCLUSION EMS with Veinoplus device at > 100 min per day ( > 5 sessions ) can decrease the rate of postoperative DVT in high risk patients . Using of EMS in patients with calf DVT does not increase the rate of PE . These findings need to be confirmed in a r and omized controlled trial BACKGROUND Current methods of posttraumatic thromboprophylaxis ( heparins and sequential compression devices ) are inadequate . New methods should be tested . Muscle electrostimulation ( MEST
Output:
| None of the studies in this comparison reported bleeding .
None of the studies in this comparison reported bleeding .
Low- quality evidence shows no clear difference in the risk of DVT between NMES and alternative methods of prophylaxis but suggest that NMES may be associated with lower risk of DVT compared with no prophylaxis ( moderate- quality evidence ) and higher risk of DVT compared with low-dose heparin ( low- quality evidence ) . |
MS211686 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objectives : To evaluate the effect on the process of care of an active strategy to implement clinical guidelines on physiotherapy for low back pain . Design : A cluster r and omised controlled trial comparing an active strategy with st and ard dissemination . Setting : Primary care physiotherapy practice s. Participants : 113 physiotherapists were r and omly allocated to receive the guidelines by mail ( control group ) or to receive an additional active strategy ( intervention group ) which consisted of a multifaceted programme including education , discussion , role playing , feedback , and reminders . Main outcome measures : Adherence to the guidelines was measured by means of individual patients ’ forms recording the treatment completed by the physiotherapist . The forms were assessed using an algorithm based on the number of treatment sessions , treatment goals , interventions , and patient education . Results : Physiotherapists in the intervention group more often correctly limited the number of treatment sessions for patients with a normal course of back pain ( OR 2.39 ; 95 % CI 1.12 to 5.12 ) , more often set functional treatment goals ( OR 1.99 ; 95 % CI 1.06 to 3.72 ) , more often used mainly active interventions ( OR 2.79 ; 95 % CI 1.19 to 6.55 ) , and more often gave adequate patient education ( OR 3.59 ; 95 % CI 1.35 to 9.55 ) . They also adhered more to all four criteria ( OR 2.05 ; 95 % CI 1.15 to 3.65 ) . Conclusions : The active strategy moderately improved adherence to the guidelines . Active strategies are recommended to implement the clinical guidelines on physiotherapy for low back pain BACKGROUND AND PURPOSE An active strategy was developed for the implementation of the clinical guidelines on physical therapy for patients with low back pain . The effect of this strategy on patients ' physical functioning , coping strategy , and beliefs regarding their low back pain was studied . SUBJECTS One hundred thirteen primary care physical therapists treated a total of 500 patients . METHODS The physical therapists were r and omly assigned to 1 of 2 groups . The control group received the guidelines by mail ( st and ard passive method of dissemination ) . The intervention group , in contrast , received an additional active training strategy consisting of 2 sessions with education , group discussion , role playing , feedback , and reminders . Patients with low back pain , treated by the participating therapists , completed question naires on physical functioning , pain , sick leave , coping , and beliefs . RESULTS Physical functioning and pain in the 2 groups improved substantially in the first 12 weeks . Multilevel longitudinal analysis showed no differences between the 2 groups on any outcome measure during follow-up . DISCUSSION AND CONCLUSION The authors found no additional benefit to applying an active strategy to implement the physical therapy guidelines for patients with low back pain . Active implementation strategies are not recommended if patient outcomes are to be improved The effects of the electronic display of guideline -based , patient-specific treatment suggestions on pharmacist work patterns were studied . A total of 28 pharmacists at a hospital-based ambulatory care pharmacy were r and omly assigned to intervention and control groups . The intervention group had access to electronic treatment suggestions for heart failure , ischemic heart disease , reactive airways disease , and uncomplicated hypertension , while the control group did not . Starting 9 and 19 months after the initial display of treatment suggestions , all pharmacists recorded the time they spent on a variety of activities , the purpose of each activity , and persons contacted during the activity ; these observations were recorded in response to a pager-like device that r and omly buzzed four times an hour . A total of 11,102 observations were recorded . Pharmacists in the intervention group spent significantly more of their time discussing information , advising and informing , and solving problems than pharmacists in the control group but significantly less of their time checking and filling prescriptions . Pharmacists in both groups completed a majority of their work alone , but pharmacists in the intervention group worked significantly less by themselves and significantly more with other pharmacy personnel , patients , and physicians and nurses than control-group pharmacists . The delivery of patient-specific information to pharmacists at the time of dispensing had a significant positive impact on pharmacist work patterns The choice of study design for guideline implementation studies will determine the confidence with which the observed effects can be attributed to the interventions under study . In general , cluster r and omized trials , of which there are different types , provide the most robust design . However , the use of these design s has implication s for the power , conduct and analysis of studies . Wherever possible , design s allowing head-to-head comparisons , which incorporate baseline measures of performance , should be used ABSTRACT Studies have shown benefits to patients from improved interventions involving antimicrobial therapy . The purpose of the present study was to evaluate prospect ively the impact of improved interventions by ( i ) the use of TheraTrac 2 , a computer software program which electronically links susceptibility testing results immediately to the pharmacy and alerts pharmacists of potential interventions , and ( ii ) the education of pharmacists involving microbiologic topics . The study group had the new intervention program . The control group had interventions performed the way that they had previously been done by manually review ing hard copies of susceptibility testing data . In a 5-month period , all in patients whose last names began with A to K were the study group ; in patients whose last names began with L to Z were controls . Three analyses were done ; one analysis ( analysis A ) involved only patients with interventions , one analysis ( analysis B ) involved all patients for whom antimicrobial testing was done and who were matched for diagnosis-related groups ( DRGs ) , regardless of whether an intervention occurred , and one analysis ( analysis C ) involved these DRG-matched patients by using severity-adjusted data . In analysis A , the study group had a 4.8 % decreased rate of mortality , an average of a 16.5-day decreased length of stay per patient , and $ 20,886 decreased variable direct costs per patient . None of these differences was statistically significant . In analysis B , the study patients had a 1.2 % higher mortality rate ( P = 0.741 ) , an average of a 2.7-day decreased length of stay per patient ( P = 0.035 ) , and $ 2,626 decreased variable direct costs per patient ( P = 0.008 ) . In analysis C , the study patients had a 1.4 % lower mortality rate , a 1.2-day decreased length of stay per patient , and $ 1,466 decreased variable direct costs per patient . In conclusion , the institution of this program caused substantial cost savings QUESTION Are implementation strategies involving education any more effective than mere dissemination of clinical practice guidelines in changing physiotherapy practice and reducing patient disability after acute whiplash ? DESIGN Cluster-r and omised trial . PARTICIPANTS Twenty-seven physiotherapists from different private physiotherapy clinics and the 103 patients ( 4 dropouts ) who presented to them with acute whiplash . INTERVENTION The implementation group of physiotherapists underwent education by opinion leaders about whiplash guidelines and the dissemination group had the guidelines mailed to them . OUTCOME MEASURES The primary outcome was patient disability , measured using the Functional Rating Index , collected on admission to the trial and at 1.5 , 3 , 6 and 12 months . Physiotherapist knowledge about the guidelines was measured using a custom-made question naire . Physiotherapist practice and cost of care were measured by audit of patient notes . RESULTS There were no significant differences between groups for any of the patient outcomes at any time . The implementation patients had 0.6 points ( 95 % CI -7.8 to 6.6 ) less disability than the dissemination patients at 12 months ; 44 % more physiotherapists in the implementation group reported that they prescribed two out of the five guideline -recommended treatments ; and 32 % more physiotherapists actually prescribed them . The cost of care for patients in the implementation group was $ 255 ( 95 % CI -1505 to 996 ) less than for patients in the dissemination group . CONCLUSION Although the active implementation program increased guideline -consistent practice , patient outcomes and cost of care were not affected PURPOSE Clinical guidelines are design ed to assist in the management of specific diseases ; however , these guidelines are often neglected in the delivery of care . The purpose of this study was to determine whether clinician use of an clinical practice guideline would increase in response to having , at the patient visit , a decision support system based on a practice guideline that generates a customized management protocol for the individual patient using data from the patient 's electronic medical record . SUBJECTS AND METHODS In a 6-month controlled trial at a primary care clinic , 58 primary care clinicians were r and omized to receive either a special encounter form with the computer-generated guideline recommendations or a st and ard encounter form . The effect of computer-generated advice on clinician behavior was measured as rate of compliance with guideline recommendations . Data from 30 clinicians were analyzed ; data from 28 clinicians were excluded because these clinicians did not meet predefined criteria for minimum exposure to diabetic patient care . RESULTS Availability of patient management recommendations generated by the decision support system result ed in a two-fold increase in clinician compliance with care guidelines for diabetes mellitus ( P = 0.01 ) . Median compliance for the group receiving the recommendations was 32.0 % versus 15.6 % for the control group . CONCLUSION Decision support based on a clinical practice guideline is an effective tool for assisting clinicians in the management of diabetic patients . This decision support system provides a model for how a clinical practice guideline can be integrated into the care process by computer to assist clinicians in managing a specific disease through helping them comply with care st and ards . Use of decision support systems based on clinical practice guidelines could ultimately improve the quality of medical care Objective : To evaluate the clinical and cost effectiveness of two training strategies to promote the use of research evidence in speech and language therapy ( SLT ) management of poststroke dysphagia . Design : Pragmatic , cluster r and omized trial . Setting : Seventeen SLT departments in north-west Engl and . Participants : Two SLTs from each department received training and cascaded information across their department . Process of care was measured from the notes of 708 patients with acute poststroke dysphagia across eight departments allocated to training strategy A , and 762 patients across nine departments in strategy B. Interventions : Strategy A : training on the critical appraisal of published research papers and practice guidelines . Strategy B : strategy A plus training on management of change in clinical practice . Main outcome measures : Pre- and post-training adherence to practice guidelines in poststroke dysphagia management , based on a review of case notes . Incremental cost of increased adherence to clinical guidelines . Results : Departments ' practice differed in adherence to guidelines . Departments changed following training ( F=2.22 , df 16 , 1436 , p=0.004 ) . The effect of training strategy on clinical practice was not significant . Strategy B departments engaged in more activities relating to research use following training than strategy A. Total costs of training averaged £ 2001 , t2892 , $ 3886 ( SD £ 502 , t726 , $ 975 ) for strategy A and £ 3366 , t4866 , $ 6537 ( SD £ 2121 , t3066 , $ 4119 ) for strategy B. Conclusions : Training in research implementation in addition to critical appraisal and guideline introduction is associated with increased dissemination activities and awareness of research information , but not with changes in clinical practice within six months of training . The department in which SLTs work influences their use of research . The process of poststroke dysphagia management can be measured using a tool developed from practice guidelines OBJECTIVE To conduct a cost analysis and cost-effectiveness study based on a r and omized clinical trial of basic nutrition care ( BC ) and practice guidelines nutrition care ( PGC ) provided by dietitians in outpatient clinics . DESIGN Subjects with non-insulin-dependent diabetes mellitus ( NIDDM ) from three states ( Minnesota , Florida , Colorado ) were r and omly assigned to a group receiving BC or a group receiving PGC for a 6-month clinical trial . Along with data about medical and clinical outcomes , data about cost re sources were collected . The cost-effectiveness of PGC compared with BC was calculated using per-patient costs and glycemic outcomes for the 6 months of the study . A net cost-effectiveness ratio comparing BC and PGC , including the cost savings result ing from changes in medical therapy , was also calculated . SUBJECTS The study reports on a sample of 179 subjects with NIDDM between the ages of 38 and 76 years who completed the clinical trial . RESULTS Patients in the PGC group experienced a mean 1.1 + /- 2.8 mmol/L decrease in fasting plasma glucose level 6 months after entry to the study , for a total per-patient cost of $ 112 . PGC costs included one glycated hemoglobin assay used by the dietitian to evaluate nutrition outcomes . Patients in the BC group experienced a mean 0.4 + /- 2.7 mmol/L decrease , for a total per-patient cost of $ 42 . In the PGC group , 17 persons had changes in therapy , which yielded an average 12-month cost savings prorated for all patients of $ 31.49 . In contrast , in the BC group , 9 persons had changes in therapy , for an average 12-month prorated cost savings of $ 3.13 . Each unit of change in fasting plasma glucose level from entry to the 6-month follow-up can be achieved with an investment of $ 5.75 by implementing BC or of $ 5.
Output:
| Multi-faceted interventions were no more effective than single intervention strategies and effects of the same strategy varied across trials .
There is no evidence to support a set guideline implementation strategy for allied health professionals . |
MS211687 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES To compare black and white nursing home residents with respect to the incidence of nursing home (NH)-acquired pressure ulcers ( PUs ) and to examine the role of resident characteristics and facility characteristics in explaining differences between the racial groups . DESIGN Prospect i ve cohort study conducted between 1992 and 1995 . SETTING Fifty-nine Maryl and NHs . PARTICIPANTS A total of 1,938 residents ( 301 black , 1,637 white ) aged 65 and older newly admitted to participating NHs . MEASUREMENTS The outcome variable was the first occurrence of a Stage 2 , 3 , or 4 PU as determined based on medical record review . The predictor variable was race ( black , white ) . Eight resident characteristics ( age , sex , number of activity of daily living dependencies , bedfast , PU on admission to facility , incontinence , dementia , and whether the resident was on Medicaid ) and three facility characteristics ( number of beds , for-profit ownership status , and urban/nonurban location ) were considered as possible confounding variables . RESULTS The incidence of PUs was 0.38 per person-year in the NH . The rate for blacks was significantly higher than for whites ( 0.56 vs 0.35 per person-year ) ( P<.001 ) . In multivariate analysis , controlling for eight resident characteristics and three facility characteristics , race was significantly associated with PU incidence ( hazard ratio comparing blacks with whites=1.31 , 95 % confidence interval=1.02 - 1.66 ) . CONCLUSION Blacks have a higher incidence of NH-acquired PUs than whites ; resident characteristics appear to mediate the higher risk . Future research should aim to identify modifiable factors that explain differences between racial groups in PU risk and to develop solutions to prevent the suffering and cost associated with PUs OBJECTIVE Hospitalizations of nursing home residents are costly and expose residents to iatrogenic disease and social and psychological harm . Economic constraints imposed by payers of care , predominantly Medicaid policies , are hypothesized to impact hospitalizations . DATA SOURCES / STUDY SETTING Federally m and ated resident assessment s were merged with Medicare cl aims and eligibility files to determine hospitalizations and death within 150 days of baseline assessment . Nursing home and market characteristics were obtained from the Online Survey Certification and Reporting , and the Area Re source File , respectively . States ' average daily Medicaid nursing home payments and bed-hold policies were obtained independently . STUDY DESIGN Prospect i ve cohort study of 570,614 older ( > or = 65-year-old ) , non-MCO ( Medicare Managed Care ) , long-stay ( > or = 90 days ) residents in 8,997 urban , freest and ing nursing homes assessed between April and June 2000 , using multilevel models to test the impact of state policies on hospitalizations controlling for resident , nursing home , and market characteristics . PRINCIPAL FINDINGS Overall , 99,379 ( 17.4 percent ) residents were hospitalized with rates varying from 8.4 percent in Utah to 24.9 percent in Louisiana . Higher Medicaid per diem was associated with lower odds of hospitalizations ( 5 percent lower for each $ 10 above average $ 103.5 , confidence intervals [ CI ] 0.91 - 0.99 ) . Hospitalization odds were higher by 36 percent in states with bed-hold policies ( CI : 1.12 - 1.63 ) . CONCLUSIONS State Medicaid bed-hold policy and per-diem payment have important implication s for nursing home hospitalizations , which are predominantly financed by Medicare . This study emphasizes the importance of properly aligning state Medicaid and federal Medicare policies in regards to the subsidy of acute , maintenance , and preventive care in the nursing home setting Given the preferential tax treatment afforded nonprofit firms , policymakers and research ers have been interested in whether the nonprofit sector provides higher nursing home quality relative to its for-profit counterpart . However , differential selection into for-profits and nonprofits can lead to biased estimates of the effect of ownership form . By using " differential distance " to the nearest nonprofit nursing home relative to the nearest for-profit nursing home , we mimic r and omization of residents into more or less " exposure " to nonprofit homes when estimating the effects of ownership on quality of care . Using national Minimum Data Set assessment s linked with Medicare cl aims , we use a national cohort of post-acute patients who were newly admitted to nursing homes within an 18-month period spanning January 1 , 2004 and June 30 , 2005 . After instrumenting for ownership status , we found that post-acute patients in nonprofit facilities had fewer 30-day hospitalizations and greater improvement in mobility , pain , and functioning RESEARCH OBJECTIVE To assess the impact of recent Medicare prospect i ve payment system ( PPS ) changes on efficiency in skilled nursing homes . DATA SOURCE / STUDY SETTING Medicare Cost Reports ( MCR ) , On-line Survey Certification and Reporting System ( OSCAR ) , Area Re source Files ( ARF ) , a Centers for Medicare and Medicaid Services ( CMS ) hospital wage index website , a Consumer Price Index ( CPI ) data base , and a survey of state Medicaid reimbursement rates . The sample was 8,361 nursing homes in the Medicare Cost Report data bases from the years 1997 to 2003 . STUDY DESIGN Data -envelopment analyses ( DEA ) calculated efficiency scores for three separate DEA models : unadjusted , acuity-adjusted , and acuity- and - quality -adjusted efficiency . The efficiency scores from these models were regressed on the Medicare PPS changes ( the Balanced Budget Act [ BBA ] , the Balanced Budget Refinement Act [ BBRA ] and the Benefits Improvement and Protection Act ) and other organizational and market explanatory variables using a panel- data truncated regression . PRINCIPAL FINDINGS Mean values for all efficiency measures decreased over time , the acuity- quality -adjusted efficiency measures decreasing the most . All policy variables were significantly negatively related to all efficiency measures . Higher nurse staffing was negatively related to efficiency in all but the acuity- quality -adjusted model . Other explanatory variables varied in their relationships to the efficiency variables . CONCLUSIONS The results suggest that the reimbursement policy changes had a significantly negative impact on efficiency . Higher nurse staffing contributed to lower efficiency only when efficiency was not adjusted for quality . Various organizational and market factors also played significant roles in all efficiency models OBJECTIVES To assess Advisory Committee for Immunization Practice s recommendations for the pneumococcal vaccine in nursing home residents using national surveys to examine factors associated with vaccination . DESIGN Cross-sectional national sample surveys of nursing homes and nursing home residents with a two-stage probability design , stratified on size and Medicare and Medicaid certification status . SETTING U.S. nursing homes during 1995 , 1997 , and 1999 . PARTICIPANTS Six current residents were r and omly selected from each facility ( n = approximately 8,000 each year ) . MEASUREMENTS Residents ' pneumococcal vaccination status was obtained by asking the facility respondent for each resident : " Has [ the resident ] EVER had a pneumococcal vaccine , that is a pneumonia vaccination ? " Vaccination status was coded as yes , no , and unknown . RESULTS The proportion of residents aged 65 and older that received pneumococcal vaccination increased significantly , from 23.6 % in 1995 to 28.2 % in 1997 to 37.4 % in 1999 ( P<.001 ) . The proportion of residents in homes with pneumococcal immunization programs increased significantly , from 65.2 % in 1995 to 88.9 % in 1999 . CONCLUSION The proportion of nursing home residents aged 65 and older receiving the pneumococcal vaccine increased significantly from 1995 to 1999 . Residents living in nursing homes with programs for pneumococcal immunizations were significantly more likely to be vaccinated Background : The Balanced Budget Act of 1997 dramatically changed the way that Medicare pays skilled nursing facilities and also cut per-diem rates . Previous studies have found effects on facility-wide staffing but not on quality for short-stay residents . Because facilities may combine revenue streams to be used where needed , spillover effects on quality of care for long-stay residents are possible . Objective : We sought to investigate effects of financial pressures from Medicare payment changes on quality of care for long-stay residents . Methods : We investigated the effect of Medicare 's Prospect i ve Payment System for skilled nursing facilities on incidence of urinary tract infections and pressure sores among long-stay residents while controlling for resident severity . We conducted panel data analysis of nursing home residents in Ohio , Kansas , Maine , Mississippi , and South Dakota using Minimum Data Set data from 1995 to 2000 . Each facility 's Medicare dependence was used to separate effects of the policy from underlying industry trends . Results : The probability of developing a urinary tract infection or pressure sore increased significantly among long-stay residents after Medicare 's prospect i ve payment system was implemented . Effects were roughly proportional to the percent of residents in a facility covered by Medicare . Conclusions : Although Medicare prospect i ve payment and rate cuts were directly applicable only to Medicare ( largely short-stay ) residents in skilled nursing facilities , the result ing financial pressures lowered the quality of care experienced by long-stay residents , as measured by the likelihood of adverse outcomes . The observed quality decreases were likely due to decreases in nurse staffing prompted by the payment reductions OBJECTIVE To examine the efficiency of the care planning process in nursing homes . METHODS We collected detailed primary data about the care planning process for a stratified r and om sample of 107 nursing homes from Kansas and Missouri . We used these data to calculate the average direct cost per care plan and used data on selected deficiencies from the Online Survey Certification and Reporting System to measure the quality of care planning . We then analyzed the efficiency of the assessment process using corrected ordinary least squares ( COLS ) and data envelopment analysis ( DEA ) . RESULTS Both approaches suggested that there was considerable inefficiency in the care planning process . The average COLS score was 0.43 ; the average DEA score was 0.48 . The correlation between the two sets of scores was quite high , and there was no indication that lower costs result ed in lower quality . For-profit facilities were significantly more efficient than not-for-profit facilities . CONCLUSIONS Multiple studies of nursing homes have found evidence of inefficiency , but virtually all have had measurement problems that raise questions about the results . This analysis , which focuses on a process with much simpler measurement issues , finds evidence of inefficiency that is largely consistent with earlier studies . Making nursing homes more efficient merits closer attention as a strategy for improving care . Increasing efficiency by adopting well- design ed , reliable processes can simultaneously reduce costs and improve quality OBJECTIVES To estimate the effect of state Medicaid nursing home reimbursement rates on hospitalizations of nursing home residents . DESIGN Cross-sectional sample of nongovernment-owned nursing homes with 25 beds or more in one Metropolitan Statistical Area in each of 10 states in 1993 , with 6 months follow-up on mortality and hospitalizations . SETTING Two hundred fifty-three nursing homes . PARTICIPANTS Eight to 16 r and omly selected residents from each facility , totaling 2,080 . MEASUREMENTS Minimum Data Set assessment s conducted by research nurses at baseline . A three-category 6-month outcome was defined as ( 1 ) any hospitalization ; for those not hospitalized , ( 2 ) death versus ( 3 ) alive in the facility . RESULTS Using multinomial logistic regression , adjusted to survey design , controlling for resident and facility characteristics , a 10 dollar increase in 1993 Medicaid reimbursement rate above the mean rate of approximately 75 dollars result ed in a 9 % reduction in a resident 's risk of hospitalization ( P<.05 ) . CONCLUSION State Medicaid reimbursement rates appear to affect clinical decisions regarding the need for hospital admission and thresholds for nursing home use . The findings from this study reemphasize the importance of properly aligning state Medicaid and federal Medicare long-term care policies because , currently , states have no incentive to increase reimbursement rates to avoid hospitalization OBJECTIVE To investigate the effects of Medicare 's Prospect i ve Payment System ( PPS ) for skilled nursing facilities ( SNFs ) and associated rate changes on quality of care as represented by staffing ratios and regulatory deficiencies . DATA SOURCES Online Survey , Certification and Reporting ( OSCAR ) data from 1996 - 2000 were linked with Area Re source File ( ARF ) and Medicare Cost Report data to form a panel data set . STUDY DESIGN A difference-in-differences model was used to assess effects of the PPS and the BBRA ( Balanced Budget Refinement Act ) on staffing and deficiencies , a design that allows the separation of the effects of the policies from general trends . Ordinary least squares and negative binomial models were used . DATA COLLECTION METHODS The OSCAR and Medicare Cost Report data are self-reported by nursing facilities ; ARF data are publicly available . Data were linked by provider ID and county . PRINCIPAL FINDINGS We find that professional staffing decreased and regulatory deficiencies increased with PPS , and that both effects were mitigated with the BBRA rate increases . The effects appear to increase with the percent of Medicare residents in the facility except , in some cases , at the highest percentage of Medicare . The findings on staffing are statistically significant . The effects on deficiencies , though exhibiting consistent signs and magnitudes
Output:
| Findings : For-profit nursing homes tend to have better financial performance , but worse results with regard to employee well-being and client well-being , compared to not-for-profit sector homes .
We argue that the better financial performance of for-profit nursing homes seems to be associated with worse employee and client well-being . |
MS211688 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Fifty three patients with asthma underwent training for two weeks in an integrated set of yoga exercises , including breathing exercises , suryanamaskar , yogasana ( physical postures ) , pranayama ( breath slowing techniques ) , dhyana ( meditation ) , and a devotional session , and were told to practise these exercises for 65 minutes daily . They were then compared with a control group of 53 patients with asthma matched for age , sex , and type and severity of asthma , who continued to take their usual drugs . There was a significantly greater improvement in the group who practised yoga in the weekly number of attacks of asthma , scores for drug treatment , and peak flow rate . This study shows the efficacy of yoga in the long term management of bronchial asthma , but the physiological basis for this beneficial effect needs to be examined in more detail " The concept of yoga is helpful for the treatment of Bronchial Asthma " , has created a great interest in the medical research field . In order to investigate whether autonomic functions and pulmonary functions are improved in asthma patients after short term yoga training , a study was conducted with nine diagnosed bronchial asthma patients . Yoga training was given for seven days in a camp in Adhyatma Sadhna Kendra , New Delhi . The autonomic function tests to measure the parasympathetic reactivity ( Deep Breathing test , Valsalva Manouever ) , Sympathetic reactivity ( H and Grip test , Cold Pressure test ) , and pulmonary function tests FVC , FEV1 , PEFR , PIF , BHT and CE were recorded before and after yoga training . The resting heart rate after yoga training ( P < 0.05 ) was significantly decreased ( 89.55 + /- 18.46/min to 76.22 + /- 16.44/min ) . The sympathetic reactivity was reduced following yoga training as indicated by significant ( P < 0.01 ) reduction in DBP after HGT . There was no change in parasympathetic reactivity . The FVC , FEV1 , PEFR did not show any significant change . The PIF ( P < 0.01 ) , BHT ( P < 0.01 ) and CE ( P < 0.01 ) showed significant improvement . The results closely indicated the reduction in sympathetic reactivity and improvement in the pulmonary ventilation by way of relaxation of voluntary inspiratory and expiratory muscles . The " comprehensive yogic life style change programme for patients of Bronchial Asthma " have shown significant benefit even within a short period Adult asthmatics , ranging from 19 to 52 years from an asthma and allergy clinic in a university setting volunteered to participate in the study . The 17 students were r and omly divided into yoga ( 9 subjects ) and nonyoga control ( 8 subjects ) groups . The yoga group was taught a set of breathing and relaxation techniques including breath slowing exercises ( pranayama ) , physical postures ( yogasanas ) , and meditation . Yoga techniques were taught at the university health center , three times a week for 16 weeks . All the subjects in both groups maintained daily symptom and medication diaries , collected A.M. and P.M. peak flow readings , and completed weekly question naires . Spirometry was performed on each subject every week . Analysis of the data showed that the subjects in the yoga group reported a significant degree of relaxation , positive attitude , and better yoga exercise tolerance . There was also a tendency toward lesser usage of beta adrenergic inhalers . The pulmonary functions did not vary significantly between yoga and control groups . Yoga techniques seem beneficial as an adjunct to the medical management of asthma The effects of two pranayama yoga breathing exercises on airway reactivity , airway calibre , symptom scores , and medication use in patients with mild asthma were assessed in a r and omised , double-blind , placebo-controlled , crossover trial . After baseline assessment over 1 week , 18 patients with mild asthma practised slow deep breathing for 15 min twice a day for two consecutive 2-week periods . During the active period , subjects were asked to breathe through a Pink City lung ( PCL ) exerciser -- a device which imposes slowing of breathing and a 1:2 inspiration : expiration duration ratio equivalent to pranayama breathing methods ; during the control period , subjects breathed through a matched placebo device . Mean forced expiratory volume in 1 s ( FEV1 ) , peak expiratory flow rate , symptom score , and inhaler use over the last 3 days of each treatment period were assessed in comparison with the baseline assessment period ; all improved more with the PCL exerciser than with the placebo device , but the differences were not significant . There was a statistically significant increase in the dose of histamine needed to provoke a 20 % reduction in FEV1 ( PD20 ) during pranayama breathing but not with the placebo device . The usefulness of controlled ventilation exercises in the control of asthma should be further investigated The effects of chest physical therapy in acute severe asthma in children have been studied in 38 children aged 6 to 13 years in a r and omized placebo controlled trial . The study began between 6 and 24 hours after admission to hospital ; 19 children received chest physical therapy ( PT ) and 19 children received placebo visits . Each child had 4 treatments over 2 days which were preceded by nebulized salbutamol . Lung volumes and flow rates were measured in a body plethysmograph before salbutamol and before and after either PT or placebo on the first and fourth treatments . Throughout the study st and ard asthma drug therapy was given . In both groups characteristics such as sex , race , age , height , weight , severity , and baseline lung function were similar . Taking into account the baseline , lung function at the end of the study was similar in both groups . Three 12 year old children in the PT group showed improvements in flows above those seen in any children in the placebo group . We conclude that chest PT , when combined with asthma drug therapy , does not improve lung function in most children in this age group with acute severe asthma In patients with asthma , the respiratory muscles have to overcome the increased resistance while they become progressively disadvantaged by hyperinflation . We hypothesized that increasing respiratory muscle strength and endurance with specific inspiratory muscle training ( SIMT ) would result in improvement in asthma symptoms in patients with asthma . Thirty patients with moderate to severe asthma were recruited into 2 groups ; 15 patients received SIMT ( group A ) and 15 patients were assigned to the control group ( group B ) and got sham training in a double-blind group-comparative trial . The training was performed using a threshold inspiratory muscle trainer . Subjects of both groups trained five times a week , each session consisted of 1/2-h training , for six months . Inspiratory muscle strength , as expressed by the PImax at RV , increased significantly , from 84.0 + /- 4.3 to 107.0 + /- 4.8 cm H2O ( p < 0.0001 ) and the respiratory muscle endurance , as expressed by the relationship between Pmpeak and PImax from 67.5 + /- 3.1 percent to 93.1 + /- 1.2 percent ( p < 0.0001 ) , in patients of group A , but not in patients of group B. This improvement was associated with significant improvements compared with baseline for asthma symptoms ( nighttime asthma , p < 0.05 ; morning tightness , p < 0.05 ; daytime asthma , p < 0.01 ; cough , p < 0.005 ) , inhaled B2 usage ( p < 0.05 ) , and the number of hospital ( p < 0.05 ) and sick-leave ( p < 0.05 ) days due to asthma . Five patients were able to stop taking oral/IM corticosteroids while on training and one in the placebo group . We conclude that SIMT , for six months , improves the inspiratory muscle strength and endurance , and results in improvement in asthma symptoms , hospitalizations for asthma , emergency department contact , absence from school or work , and medication consumption in patients with asthma Twelve subjects with mild asthmatic episodes in the form of nocturnal precipitation were studied . A two-week schedule of placebo administration , pranayamic breathing exercises using a Pink City lung exerciser alone , and exercises using the lung exerciser with hot , humid air were performed . Five of the 12 asthmatics showed highly significant increases in peak expiratory flow rate ( PEFR ) with the lung exerciser alone , while eight of the 12 cases showed highly significant increases in PEFR with exercise using hot , humid air . The frequency of nocturnal wheezing also declined . It can be inferred that slow breathing alone and in combination with hot , humid air has a nonspecific bronchoprotective or bronchorelaxing effect A new diaphragmatic breathing technique practice d without the aid of a physical corset is outlined , and the findings from a study of its application in the respiratory rehabilitation of asthmatic patients are presented . Sixty-seven asthmatic adults r and omly assigned to either deep diaphragmatic breathing training , physical exercise training , or a waiting list control group participated in a 16-week program . Deep diaphragmatic training result ed in significant reductions in medication use and in the intensity of asthmatic symptoms . Importantly , a nearly 300 % increase in time spent in physical activities also result ed from deep diaphragmatic training . A follow-up at two months found many patients had returned to earlier medication levels and sedentary habits . A strengthened musculature can replace the need for a physical aid in this respiratory habilitation ; adherence to its use may require individually-tailored encouragement The heart rate , breathing rate , and skin resistance were recorded for 20 community home girls ( Home group ) and for 20 age-matched girls from a regular school ( School group ) . The former group had a significantly higher rate of breathing and a more irregular breath pattern , known to correlate with high fear and anxiety , than the School group . Skin resistance was significantly lower in the School group , which may suggest greater arousal . 28 girls of the Home group formed 14 pairs , matched for age and duration of stay in the home . Subjects of a pair were r and omly assigned to either yoga or games groups . For the former emphasis was on relaxation and awareness , whereas for the latter increasing physical activity was emphasized . At the end of an hour daily for six months both groups showed a significant decrease in the resting heart rate relative to initial values ( Wilcoxon paired- sample test ) , and the yoga group showed a significant decrease in breath rate , which appeared more regular but no significant increase in the skin resistance . These results suggest that a yoga program which includes relaxation , awareness , and grade d physical activity is a useful addition to the routine of community home children
Output:
| Collectively the data imply that physiotherapeutic breathing techniques may have some potential in benefiting patients with asthma . |
MS211689 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Based on the evidence that lamotrigine added to clozapine in refractory schizophrenic patients has reported promising results , the present 24-week double-blind , r and omized , placebo-controlled trial had the aim to explore the efficacy of lamotrigine add-on pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of treatment-resistant schizophrenic patients receiving clozapine . After clinical and neurocognitive assessment s patients were r and omly allocated to receive , in a double-blind design , either up to 200 mg/day of lamotrigine or a placebo . A final sample of fifty-one patients completed the study . The results obtained indicate that lamotrigine added to stable clozapine treatment showed a beneficial effect on the negative , positive and general psychopathological symptomatology in a sample of treatment-resistant schizophrenic patients . Regarding cognitive functions , improvement was observed in some explored areas , such as attentional resistance to interference , verbal fluency and executive functioning . The findings provide evidence that lamotrigine augmentation of clozapine treatment is well tolerated and may be proposed as an effective therapeutic strategy to improve outcome in treatment-resistant schizophrenia Background Dysfunction of neuroplasticity due to N-methyl-d-aspartate ( NMDA ) receptor hypofunction may be a causal factor for memory and executive dysfunctioning in schizophrenia . Deregulation of NMDA transmission in the prefrontal cortex may also explain negative and positive symptoms . Clozapine augmentation with memantine targets altered NMDA receptor-mediated neurotransmission in schizophrenia and showed substantial beneficial effects on several symptom domains in a small proof-of-concept study . We evaluate effects of memantine add-on treatment to clozapine for memory and executive function , and negative and positive symptoms in schizophrenia . Method Clozapine-treated patients with refractory schizophrenia were r and omly assigned to 12 weeks of double-blind adjunctive treatment with memantine ( n = 26 ) or placebo ( n = 26 ) . Crossover occurred after a 2-week placebo wash-out period . Primary endpoints were change from baseline to 12 weeks treatment and 14 weeks to 26 weeks treatment on memory and executive function using the Cambridge Neuropsychological Test Automated Battery ( CANTAB ) , Positive and Negative Syndrome Scale ( PANSS ) , and Clinical Global Impression Severity Scale ( CGI-S ) . Side effects were assessed using the Liverpool University Neuroleptic Side-Effect Rating Scale . Results When compared with placebo , memantine improved a composite memory score comprising verbal recognition memory and paired associates learning task scores on the CANTAB ( effect size = 0.30 ) and PANSS negative subscale score ( effect size = 0.29 ) . Side effects were mild and transient . Conclusions In patients with clozapine-treated refractory schizophrenia , memantine addition significantly improved verbal and visual memory and negative symptoms without serious adverse effects . These results justify further investigations on long-term memantine augmentation to clozapine in treatment-resistant schizophrenia Schizophrenia is a devastating psychiatric disorder . Clozapine has long been the gold st and ard for treatment of patients with treatment-resistant schizophrenia ; however , some patients are only partially responsive to clozapine treatment . Augmentation of clozapine treatment might enhance its effectiveness in partial responders , but only a few studies have investigated possible augmentation strategies . This study compared the effectiveness and tolerability of the combination of amisulpride and clozapine with the combination of quetiapine and clozapine in patients who were only partially responsive to clozapine monotherapy . Fifty-six treatment-resistant patients who were partially responsive to clozapine were r and omly assigned to receive amisulpride or quetiapine along with an ongoing stable dose of clozapine . Fifty patients completed the study . Patients were evaluated at baseline and at the first , third , sixth , and eighth weeks . Efficacy measures consisted of the Brief Psychiatric Rating Scale ( BPRS ) , the Scale for the Assessment of Negative Symptoms ( SANS ) , the Scale for the Assessment of Positive Symptoms ( SAPS ) , and the Clinical Global Impression ( CGI ) scale . Tolerability and adverse effects were assessed with the Udvalg for Kliniske Undersogelser ( UKU ) Side Effect Rating Scale and the Simpson Angus Scale ( SAS ) . A substantial improvement occurred in both groups by the end of the eighth week ; however , the improvement associated with amisulpride was significantly greater than that seen with quetiapine . This difference was noted as early as the third week of follow-up in terms of CGI scores , and by the sixth week with regard to BPRS , SANS , and SAPS scores . Both drugs were well tolerated , as measured by UKU and SAS . Improvement favoring clozapine+amisulpride could be attributed to the selective D2/D3 binding property of amisulpride , which had an additional effect in improving symptoms of schizophrenia . The authors concluded that amisulpride seems to be effective and well tolerated for augmentation purpose s in clozapine-resistant patients Schizophrenia is a complex and heterogeneous psychiatric disorder . Auditory verbal hallucinations occur in 50 - 70 % of patients with schizophrenia and are associated with significant distress , decreased quality of life and impaired social functioning . This study aim ed to investigate the effects of active compared with sham 1-Hz repetitive transcranial magnetic stimulation ( rTMS ) applied to the left temporal-parietal cortex in patients with schizophrenia treated with clozapine . Symptom dimensions that were evaluated included general psychopathology , severity of auditory hallucinations , quality of life and functionality . Seventeen right-h and ed patients with refractory schizophrenia experiencing auditory verbal hallucinations and treated with clozapine were r and omly allocated to receive either active rTMS or sham stimulation . A total of 384 min of rTMS was administered over 20 days using a double-masked , sham-controlled , parallel design . There was a significant reduction in Brief Psychiatric Rating Scale ( BPRS ) scores in the active group compared with the sham group . There was no significant difference between active and sham rTMS on Quality of Life Scale ( QLS ) , Auditory Hallucinations Rating Scale ( AHRS ) , Clinical Global Impressions ( CGI ) and functional assessment staging ( FAST ) scores . Compared with sham stimulation , active rTMS of the left temporoparietal cortex in clozapine-treated patients showed a positive effect on general psychopathology . However , there was no effect on refractory auditory hallucinations . Further studies with larger sample sizes are needed to confirm these findings Objective Clozapine is the most effective antipsychotic for treatment refractory people with schizophrenia , yet many patients only partially respond . Accumulating pre clinical and clinical data suggest benefits with minocycline . We tested adjunct minocycline to clozapine in a 10-week , double-blind , placebo-controlled trial . Primary outcomes tested were positive , and cognitive symptoms , while avolition , anxiety/depression , and negative symptoms were secondary outcomes . Methods Schizophrenia and schizoaffective participants ( n = 52 ) with persistent positive symptoms were r and omized to receive adjunct minocycline ( 100 mg oral capsule twice daily ; n = 29 ) or placebo ( n = 23 ) . Results Brief Psychiatric Rating Scale ( BPRS ) psychosis factor ( P = 0.098 ; effect size [ ES ] , 0.39 ) and BPRS total score ( P = 0.075 ; ES , 0.55 ) were not significant . A change in total BPRS symptoms of more than or equal to 30 % was observed in 7 ( 25 % ) of 28 among minocycline and 1 ( 4 % ) of 23 among placebo participants , respectively ( P = 0.044 ) . Global cognitive function ( MATRICS Consensus Cognitive Battery ) did not differ , although there was a significant variation in size of treatment effects among cognitive domains ( P = 0.03 ) , with significant improvement in working memory favoring minocycline ( P = 0.023 ; ES , 0.41 ) . The Scale for the Assessment of Negative Symptoms total score did not differ , but significant improvement in avolition with minocycline was noted ( P = 0.012 ; ES , 0.34 ) . Significant improvement in the BPRS anxiety/depression factor was observed with minocycline ( P = 0.028 ; ES , 0.49 ) . Minocycline was well tolerated with significantly fewer headaches and constipation compared with placebo . Conclusions Minocycline 's effect on the MATRICS Consensus Cognitive Battery composite score and positive symptoms were not statistically significant . Significant improvements with minocycline were seen in working memory , avolition , and anxiety/depressive symptoms in a chronic population with persistent symptoms . Larger studies are needed to vali date these findings Despite its superior efficacy , clozapine is helpful in only a subset of patients with schizophrenia unresponsive to other antipsychotics . This lack of complete success has prompted the frequent use of various clozapine combination strategies despite a paucity of evidence from r and omized controlled trials supporting their efficacy . Pimozide , a diphenylbutylpiperidine , possesses pharmacological and clinical properties distinct from other typical antipsychotics . An open-label trial of pimozide adjunctive treatment to clozapine provided promising pilot data in support of a larger controlled trial . Therefore , we conducted a double-blind , placebo-controlled , parallel- design ed 12-week trial of pimozide adjunctive treatment added to ongoing optimal clozapine treatment in 53 patients with schizophrenia and schizoaffective disorder partially or completely unresponsive to clozapine monotherapy . An average dose of 6.48 mg/day of pimozide was found to be no better than placebo in combination with clozapine at reducing Positive and Negative Syndrome Scale total , positive , negative , and general psychopathology scores . There is no suggestion from this rigorously conducted trial to suggest that pimozide is an effective augmenting agent if an optimal clozapine trial is ineffective . However , given the lack of evidence to guide clinicians and patients when clozapine does not work well , more controlled trials of innovative strategies are warranted BACKGROUND The treatment of schizophrenia with multiple antipsychotic drugs is common , but the benefits and risks are not known . METHODS In a r and omized , double-blind study , we evaluated patients with schizophrenia and a poor response to treatment with clozapine . The patients continued to take clozapine and were r and omly assigned to receive eight weeks of daily augmentation with 3 mg of risperidone or with placebo . This course of treatment was followed by an optional 18 weeks of augmentation with risperidone . The primary outcome was reduction in the total score for severity of symptoms on the Positive and Negative Syndrome Scale ( PANSS ) . The secondary outcomes included cognitive functioning . RESULTS A total of 68 patients were r and omly assigned to treatment . In the double-blind phase , the mean total score for the severity of symptoms decreased from baseline to eight weeks in both the risperidone and the placebo groups . There was no statistically significant difference in symptomatic benefit between augmentation with risperidone and placebo : 9 of 34 patients receiving placebo and 6 of 34 receiving risperidone responded to treatment ( P=0.38 ) . The mean difference in the change in PANSS scores from baseline to eight weeks between those receiving risperidone and those receiving placebo was 0.1 ( 95 percent confidence interval , -7.3 to 7.0 ) . The verbal working-memory index showed a small decline in the risperidone group and a small improvement in the placebo group ( P=0.02 for the comparison between the two groups in the change from baseline ) . The increase in fasting blood glucose levels was mildly greater in the risperidone group than in the placebo group ( 16.2 vs. 1.8 mg per deciliter [ 0.90 vs. 0.10 mmol per liter ] , P=0.04 ) . The incidence and severity of other side effects did not differ between the two groups . CONCLUSIONS In this short-term study , the addition of risperidone to clozapine did not improve symptoms in patients with severe schizophrenia . ( Clinical Trials.gov number , NCT00272584 ) BACKGROUND We hypothesised that a combined regimen of clozapine , a relatively weak D2-dopaminergic antagonist , and sulpiride , a selective D2 blocker , would demonstrate a greater antipsychotic efficacy by enhancing the D2 blockade of clozapine . METHOD Twenty-eight people with schizophrenia , previously unresponsive to typical antipsychotics and only partially responsive to current treatment with clozapine , received , double-blind , 600 mg/day sulpiride or placebo , in addition to an ongoing clozapine treatment . The clinical status was evaluated before , during , and at the end of 10 weeks of sulpiride addition using the Brief Psychiatric Rating Scale ( BPRS ) , Scale for the Assessment of Positive Symptoms ( SAPS ) , Scale for the Assessment of Negative Symptoms , and Hamilton Rating Scale for Depression . RESULTS The clozapine-sul
Output:
| Single studies of certain antipsychotics ( penfluridol ) , antidepressants ( paroxetine , duloxetine ) , lithium and Ginkgo biloba showed potential , while electroconvulsive therapy was highly promising .
Mixed treatment comparisons were only possible for antipsychotics , and these gave similar results to the pairwise meta-analyses .
Conclusions : On the basis of the limited data available , the best evidence is for the use of aripiprazole , fluoxetine and sodium valproate as augmentation agents for total psychosis symptoms and memantine for negative symptoms . |
MS211690 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Objective : To evaluate the effect of oral administration of selenium and zinc tablets in patients with cancer of the digestive tract during chemotherapy . Design : A case – control , r and omized study . Setting : Medical Oncology , II University of Naples , Naples , Italy . Subjects : A total of 60 patients ( median age 55 y , range 46–61 y ) with diagnosis of gut cancer were r and omized in 1999 . Patients were treated for 60 days with chemotherapy . Interventions : Trace elements were measured by atomic absorption spectroscopy . The nutritional status of the patients was assessed by biochemical and bio-impedance analysis ( BIA ) parameters in basal condition and after 60 days of treatment . Oral administration of selenium and zinc in oral tablet form for 50 days was Se 200 μg/day ( 50 μg/tablet ) and Zn 21 mg/day ( 7 mg/tablet ) . Results : Both in the basal condition and at 60 days all patients were malnourished . Selenium and zinc concentrations were significantly lower ( P<0.01 ) whereas copper concentration was significantly higher ( P<0.01 ) in cancer patients than in control subjects . However , 21/30 ( 70 % ) of those treated with Se and Zn did not showed a further worsening of nutritional status and experienced a significant decrease of asthenia with an increase of appetite . On the other h and , 24/30 ( 80 % ) untreated patients had a significant decline of all parameters studied after 60 days ( prealbumin , cholesterol , transferrin , P<0.05 vs 0 time ; total proteins , albumin/globulin ratio , P<0.01 vs 0 time ; fat-free mass , fat mass , Na+/K+ ratio , body mass index P<0.05 vs 0 time ; fat free mass/fat mass , total body water , extra cellular/intra cellular water , basal metabolic rate : P<0.01 vs 0 time ) . Conclusions : Data indicate that Se and Zn supplementation may improve the clinical course of general conditions in patients with gut cancer . These effects of Se and Zn require confirmation in an independent trial of appropriate design before new public health recommendations regarding Se and Zn supplementation can be made . European Journal of Clinical Nutrition ( 2001 ) 55 , A national cooperative group trial was conducted in 153 patients with chronic myelogenous leukemia ( CML ) in chronic phase treated with oral pulse busulfan to determine if oral vitamin A can increase the time to blast crisis and enhance survival of patients . Patients diagnosed within 1 year and in the chronic phase of CML were r and omized to receive oral pulse busulfan or the alkylator plus continuous oral vitamin A. Distributions of clinical progression and overall survival were estimated using the method of Kaplan and Meier . Associations of these endpoints with treatment and other patient characteristics were analyzed using the proportional hazards regression method of Cox . Both regimes were well tolerated . Patients in the busulfan plus vitamin A arm had somewhat longer duration s of clinical progression-free survival ( median 46 months ) and overall survival ( 51 months ) compared to those in the busulfan arm ( medians 38 and 44 months ) . However , the differences were not statistically significant ( one-tailed P = 0.11 for clinical progression-free survival , 0.081 for survival ) . After adjustment for significant factors identified in an additional exploratory multivariate analysis , risk of clinical progression or death was 53 % ( P = 0.022 ) greater and risk of death 60 % ( P = 0.014 ) greater among busulfan patients . Given the relatively large though non-significant difference between treatment arms , the limited statistical power of the study , and the likelihood that oral vitamin A may not be the most effective means of delivering retinoid therapy , we conclude that further investigation of retinoids in chronic phase CML is warranted Two groups of children with acute lymphoblastic leukemia or non-Hodgkin lymphoma , treated with anthracyclines ( ANT ) , were studied : group I , consisting of 10 patients , with coenzyme Q10 ( CoQ ) therapy ; group II , consisting of 10 patients without CoQ therapy . The ANT cumulative dose was 240 + /- 20.0 mg/m2 in group I and 252.0 + /- 20.1 mg/m2 in group II . Echocardiographic study was performed at the beginning , at the cumulative dose of 180 mg/m2 and at the end of therapy with ANT . Percentage left ventricular fractional shortening ( % LVFS ) decreased from baseline ( 40.36 + /- 4.6 ) to end value ( 35.82 + /- 5.02 ) ( P < 0.05 ) in group I ; % LVFS decreased from baseline ( 39.89 + /- 4.37 ) to end value ( 33.43 + /- 3.46 ) ( P < 0.002 ) in group II . Interventricular septum wall thickening decreased only in group II from baseline ( 46.10 + /- 10.1 ) to end therapy ( 27.00 + /- 18.54 ) ( P < 0.01 ) . Septum wall motion abnormalities were detected only in 2 patients of group II . These data demonstrate a protective effect of CoQ on cardiac function during therapy with ANT Ratios of urinary 8‐hydroxy‐2′‐deoxyguanosine to urinary creatinine ( 8‐OHdG/creatinine ) have been considered as a good biological indicator of DNA oxidation . Urinary 8‐OHdG/creatinine levels of lung cancer patients were evaluated by enzyme‐linked immunosorbent assay using a monoclonal antibody N45.1 during radiotherapy and chemotherapy . An increase in urinary 8‐OHdG/creatinine was found in non‐small‐cell carcinoma ( non‐SCC ) patients during the course of radiotherapy . SCC patients showed higher levels of urinary 8‐OHdG/creatinine than the controls . Furthermore , SCC patients with complete or partial response to the chemotherapy showed a significant decrease in urinary 8‐OHdG/creatinine while patients with no change or progressive disease showed an increase Oxaliplatin is effective in the treatment of metastatic colorectal cancer ( MCRC ) patients ; however , severe neurotoxicity develops frequently . To assess the efficacy of oral glutamine for preventing neuropathy induced by oxaliplatin , a pilot study was performed . A total of 86 patients with MCRC treated at Taipei Veterans General Hospital were enrolled . Oxaliplatin ( 85 mg/m(2 ) , days 1 and 15 ) plus weekly bolus 5-fluorouracil ( 5-FU ; 500 mg/m(2 ) ) and folinic acid ( FA ; 20 mg/m(2 ) ) on days 1 , 8 , and 15 were given every 28 days as first-line treatment . Patients were r and omized to receive ( glutamine group ; n = 42 ) or not receive ( control group ; n = 44 ) glutamine ( 15 g twice a day for seven consecutive days every 2 weeks starting on the day of oxaliplatin infusion ) . Efficacy of chemotherapy , neurological toxicity , and electrophysiological alterations were assessed . A lower percentage of grade 1 - 2 peripheral neuropathy was observed in the glutamine group ( 16.7 % versus 38.6 % ) after two cycles of treatment , and a significantly lower incidence of grade 3 - 4 neuropathy was noted in the glutamine group after four cycles ( 4.8 % versus 18.2 % ) and six cycles ( 11.9 % versus 31.8 % ) . By adding glutamine , interference with activities of daily living was lower ( 16.7 % versus 40.9 % ) , and need for oxaliplatin dose reduction was lower ( 7.1 % versus 27.3 % ) . There were no significant between-group differences in response to chemotherapy ( 52.4 % versus 47.8 % ) , electrophysiological abnormalities , grade 3 - 4 non-neurological toxicities ( 26.2 % versus 22.8 % ) , or survival . These data indi-cate that oral glutamine significantly reduces the incidence and severity of peripheral neuropathy of MCRC patients receiving oxaliplatin without affecting response to chemotherapy and survival Summary A significant myeloprotective effect of melatonin in mice treated with etoposide , cyclophosphamide or carboplatin has been reported . The present study was design ed to evaluate if the same effect could be observed in patients receiving chemotherapy . Twenty previously untreated patients with inoperable lung cancer received two cycles of carboplatin ( given at area under the curve 5 by the Calvert formula ) on day 1 and etoposide ( 150 mg m–2 i.v . ) on days 1–3 every 4 weeks . Melatonin 40 mg or placebo ( double-blind ) was given orally in the evening for 21 consecutive days , starting 2 days before chemotherapy . Patients were r and omized to receive melatonin either with the first or the second cycle . Complete blood cell count with differential was done three times per week for 3 weeks . The median age of the cohort was 60 years ( range 42–69 ) , 16 patients had non-small cell and four patients small-cell lung cancer , 12 stage III and eight stage IV disease . In a multivariate analysis including age , sex , diagnosis , stage , performance status , doses of carboplatin and etoposide , and concomitant treatment with melatonin or placebo , the haematological parameters – depth and duration of toxicity for haemoglobin , platelets and neutrophils ( ANC ) – were not significantly different between cycles with/without melatonin . The mean ANC nadir and the mean number of days with ANC < 0.5 × 109 l–1 were 0.5 × 109 l–1 and 2.5 days , respectively , with/without melatonin . We concluded that , in patients with lung cancer , melatonin given orally at a dose of 40 mg per day for 21 days in the evening , does not protect against the myelotoxic effect of carboplatin and etoposide PURPOSE Glutathione has been shown to be an effective chemoprotector against cisplatin-induced side effects in patients with ovarian cancer . In view of this fact , we performed a r and omized clinical pilot-trial in the management of other solid tumors in order to compare application of Glutathione to intensive hydration in patients undergoing chemotherapy with a regimen including cisplatin . PATIENTS AND METHODS Twenty patients suffering from advanced non small cell lung cancer ( n = 6 ) or head- and neck cancer ( n = 14 ) were enrolled in the study . All patients received 80 mg/m2 cisplatin along with etoposide or 5-fluorouracil every 4 weeks . Patients r and omized to application of Glutathione ( n = 11 ) received 5 g of Glutathione immediately before application of cisplatin followed by 2000 ml of normal saline . Patients in the control group ( n = 9 ) received 2000 ml electrolyte infusion before and 2000 ml of normal saline with forced diuresis after cisplatin . RESULTS The intensity of hematologic toxicity was significantly less pronounced in patients treated with Glutathione than in the control group ( hemoglobin : 10.7 vs 9.5 mg% respectively , p = 0.039 ; white blood cell count 3.3 vs 2.2 x 103/microliter respectively , p = 0.004 ; platelets 167 vs 95 x 103/microliter respectively , p = 0.02 ) , whereas in terms of non-hematologic toxicity no difference was observed . Objective remission occurred in 6 out of 11 evaluable patients from the group receiving Glutathione ( 55 % ; complete remission : 9 % ; partial remission : 46 % ) , and in 4 out of 8 evaluable patients from the control group ( partial remission : 50 % ) . However , there was no statistical difference in terms of response and overall survival ( 13.5 months vs. 10.5 months ) between the two groups . CONCLUSIONS Application of Cisplatin and Glutathione seems to be safe and feasible and the antitumoral efficacy of cisplatin is apparently not impaired by the concomitant use of Glutathione in patients with solid tumors Aim A r and omized , open label with blind assessment , controlled trial was performed to assess efficacy and adverse-event profile of vitamin E , given as supplementation for prophylaxis against cisplatin-induced peripheral neuropathy ( CIPN ) . Patients and methods A total of 30 patients scheduled to receive six courses of cumulative cisplatin-based regimens were r and omly allocated to treatment and control groups and were then studied by means of neurological examination and electrophysiological study . Patients assigned to group I ( n=14 ) orally received vitamin E at a daily dose of 600 mg/day during chemotherapy and 3 months after its cessation were compared to patients of group II ( n=16 ) , who received no vitamin E supplementation and served as controls . The severity of neurotoxicity was summarized by means of a modified Peripheral Neuropathy ( P
Output:
| This review provides the first systematic ally review ed evidence that antioxidant supplementation during chemotherapy holds potential for reducing dose-limiting toxicities . |
MS211691 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND : Our aim was to investigate postoperative complications and mortality after administration of aprotinin compared to tranexamic acid in an unselected , consecutive cohort . METHODS : Perioperative data from consecutive cardiac surgery patients were prospect ively collected between September 2005 and June 2006 in a university-affiliated clinic ( n = 1188 ) . During the first 5 mo , 596 patients received aprotinin ( Group A ) ; in the next 5 mo , 592 patients were treated with tranexamic acid ( Group T ) . Except for antifibrinolytic therapy , the anesthetic and surgical protocol s remained unchanged . RESULTS : The pre- and intraoperative variables were comparable between the treatment groups . Postoperatively , a significantly higher incidence of seizures was found in Group T ( 4.6 % vs 1.2 % , P < 0.001 ) . This difference was also significant in the primary valve surgery and the high risk surgery subgroups ( 7.9 % vs 1.2 % , P = 0.003 ; 7.3 % vs 2.4 % , P = 0.035 , respectively ) . Persistent atrial fibrillation ( 7.9 % vs 2.3 % , P = 0.020 ) and renal failure ( 9.7 % vs 1.7 % , P = 0.002 ) were also more common in Group T , in the primary valve surgery subgroup . On the contrary , among primary coronary artery bypass surgery patients , there were more acute myocardial infa rct ions and renal dysfunction in Group A ( 5.8 % vs 2.0 % , P = 0.027 ; 22.5 % vs 15.2 % , P = 0.036 , respectively ) . The 1-yr mortality was significantly higher after aprotinin treatment in the high risk surgery group ( 17.7 % vs 9.8 % , P = 0.034 ) . CONCLUSION : Both antifibrinolytic drugs bear the risk of adverse outcome depending on the type of cardiac surgery . Administration of aprotinin should be avoided in coronary artery bypass graft and high risk patients , whereas administration of tranexamic acid is not recommended in valve surgery Studies that compare the use of HTK vs. blood or crystalloid cardioplegia for myocardial protection in cardiac surgery , r and omized or non-r and omized , will be selected . Large case series of adult cardiac surgery with the use of HTK for myocardial protection but without a comparator , including more than 100 patients will be included in a separate analysis . Electronic search es will be performed of Medline , the Cochrane Data base of Systematic Review s , Pubmed and EMBASE . Manual search es of reference lists will be used to identify any studies not found in the initial search . Only studies in English will be included . Abstract s , letters , and review articles will be excluded . Differences of opinion between review ers will be discussed with a senior investigator . An in/out form will be prepared to assess studies for inclusion or exclusion using predetermined inclusion criteria . The inclusion of studies will be assessed by two independent review ers , with differences of opinion resolved by discussion with a senior investigator . A PRISMA flow-diagram will summarize inclusion /exclusion of studies . Level of evidence for each study will be reported to assess the quality of the evidence BACKGROUND Ischemia-reperfusion injury during open heart surgery related to unsuccessful myocardial protection may increase morbidity or mortality . We analyze the clinical outcome after cardiac surgery with a cardioplegic solution based on intracellular components added with histidine-ketoglutarate-tryptophan . METHODS Thirty patients programmed for elective open heart surgery were r and omized into two groups . In group I ( n = 15 ) , myocardial protection was carried out with Bretschenider solution ( HTK ) , and in group II ( n = 15 ) with conventional crystalloid cardioplegia . The incidence of arrhythmias , inotropic support requirement , and length-of-stay in the intensive care unit were evaluated . RESULTS During reperfusion , there was no difference in incidence of arrhythmias ; however , in the postoperative period group I had a lower incidence of arrhythmias ( p = 0.001 ) . Inotropic support ( p = 0.003 ) and length-of-stay in the intensive care unit ( p = 0.037 ) were lower in group I. There were no deaths in either group . CONCLUSIONS It was concluded that myocardial protection with Bretschneider solution effectively decreases incidence of arrhythmias , inotropic support , and length-of-stay in the intensive care unit The study compares the single dose histidine-tryptophan-ketoglutarate ( HTK ) cardioplegia to the repeatedly delivered St Thomas ' Hospital Solution ( STHS ) with respect to preservation of left ventricular mechanoenergetics and leakage of troponin T in a porcine experimental model . Fourteen pigs were r and omized to a single infusion of 30 ml/kg HTK cardioplegia ( n=7 ) or 500 ml STHS ( n=7 ) followed by 200 ml after 20 and 40 min . After 1 h of aortic cross-clamping on cardiopulmonary bypass ( CPB ) , the pigs were weaned and the hearts reperfused for 4 h. Stroke work ( SW ) was determined by a conductance catheter in the left ventricle . Myocardial oxygen consumption ( MvO(2 ) ) was measured as a function of coronary blood flow and arterial-to-coronary sinus oxygen saturation difference . Troponin T was sample d from the coronary sinus . The slope of the SW-MvO(2 ) relationship increased by 1.09 ( + /-0.53 ) in the HTK group compared with 0.33 ( + /-0.70 ) in the STHS group following ischemia and 4 h of reperfusion ( P=0.04 ) . Troponin T was significantly higher in the HTK group compared with the STHS group ( P=0.04 ) . Repeatedly delivered STHS gives better preservation of postischemic mechanoenergetic function and lower troponin T release compared with single dose HTK cardioplegia , indicating improved cardioprotection with STHS Abstract Objectives . To clarify the reliability of the one-shot histidine – tryptophane – ketoglutarate ( HTK ) cardioplegia for right ventricular ( RV ) myocardial protection during mitral surgery , in patients with or without pre-operative RV dysfunction . Design . Sixty patients undergoing isolated mitral surgery were r and omized to myocardial protection with either one-shot HTK or intermittent warm blood cardioplegia ( WBC ) . The RV function was assessed by echocardiography and hemodynamic assessment . Pre-operative tricuspid annular plane systolic excursion ( TAPSE ) , an index of RV systolic function was used to dichotomize groups into patients having impaired ( TAPSE < 15 ) or preserved ( TAPSE ≥ 15 ) RV function . Results . There were no significant intergroup differences in the post-operative indexes of RV function in cases with TAPSE ≥ 15 . In patients having TAPSE < 15 we observed statistically worse RV ejection fraction ( RVEF , 15 % ± 2 % vs. 24 % ± 3 % ) , end-diastolic volume ( RVEDV , 188 mL ± 20 vs. 179 mL ± 14 ) and fractional area change ( RVFAC , 21 % ± 6 % vs. 30 % ± 3 % ) after use of the HTK solution versus patients who received the WBC . These differences were associated with longer mechanical ventilation and ICU times in patients with impaired RV function and receiving HTK cardioplegia . In a sub study ten patients with TAPSE < 15 received intra-operative topical myocardial cooling in addition to HTK . The addition of topical cooling to HTK cardioplegia yielded statistically significant amelioration in post-operative RV function compared with patients who received the HTK solution without topical cooling ( RVEF : 23 % ± 3 % vs. 15 % ± 2 % ; RVEDV : 180 mL ± 9 vs. 188 mL ± 18 ; RVFAC : 8.5 % ± 1 % vs. 6 % ± 2 % ) . Conclusions . The one shot HTK solution offers inferior RV protection compared with WBC , mainly in patients with depressed pre-operative RV function . When adopting HTK cardioplegia the addition of topical cooling is strongly advised OBJECTIVES A single or dual-dose strategy for myocardial protection is attractive in long operations , in avoiding the need to interrupt the procedure to re-administer cardioplegia . We hypothesized that a single administration of Bretschneider histidine-tryptophan-ketoglutarate ( HTK ) crystalloid solution ( Custodiol ) offers myocardial protection comparable with repeated tepid blood cardioplegia . METHODS We review ed a prospect ively compiled single-centre data base containing all adult cardiac procedures performed from January 2005 to January 2011 . Preoperative demographic and investigative data , operative variables and postoperative ( 30-day ) mortality and morbidity were compared between the Custodiol and blood cardioplegia groups . The study primary endpoints were 30-day mortality , return to the operating theatre , myocardial infa rct ion , stroke , postoperative requirement for an intra-aortic balloon pump , new renal failure , prolonged ventilation and re-admission to hospital within 30 days . Propensity score matching was performed to correct for any bias that may have been associated with the usage of Custodiol . RESULTS A total of 1900 cardiac surgical procedures were identified of which 126 ( 7 % ) utilized Custodiol and 1774 ( 93 % ) used blood cardioplegia as the primary cardioplegic agent . After propensity-score matching , we were able to match 71 Custodiol cases one-to-one to those receiving blood cardioplegia . There were no statistically significant differences noted for any of the endpoints studied after propensity-score matching . In particular , the proportion of mortality ( blood cardioplegia : 1 vs Custodiol 4 % , P = 0.63 ) any mortality/morbidity ( blood cardioplegia : 35 vs Custodiol : 39 % P = 0.46 ) was similar between the groups . CONCLUSIONS The use of Custodiol is convenient , simple and at least as safe as tepid blood cardioplegia for myocardial protection in complex cardiac operations . A r and omized prospect i ve comparison of myocardial protection strategies is warranted OBJECTIVE Intermittend , hypothermic aortic cross-clamping ( IAC ) with myocardial fibrillation and cardioplegic arrest ( CA ) have been established both as effective methods for coronary artery bypass surgery ( CABG ) . Nevertheless , there exists controversy about the more beneficial cardioprotective effect of one of these procedures in CABG- patients . METHODS In this prospect i ve study we compared the clinical outcome , ischemic serum-markers ( CK , CK-MB , Troponin I ) , electrocardiogram (ECG)-changes , and hemodynamic data of 103 patients . R and omization in group I ( IAC ; n=52 ) or group II ( CA ; n=51 ) was done consecutively , all data were compared by Student 's t-test or chi(2)-test and P<0.05 was regarded as significant . The Bretschneider-HTK solution was used for cardioplegic arrest . Data were collected before operation , before ischemic arrest , after 5 and 60 min of reperfusion , 1 and 6 h after operation , 1 , 2 and 10 days postoperatively . RESULTS There were no significant differences between both groups regarding general patient data : age ( IAC : 64 . 8+/-9.2 vs. CA : 63.8+/-9.0 years ) , left ventricular function ( ejection fraction : IAC : 62+/-14 vs. CA : 64+/-13 % ) , the amount of bypassed vessels ( IAC : 3.4+/-0.5 vs. CA : 3.6+/-0.5 ) , total bypass time ( IAC : 113+/-31 vs. CA 108+/-20 min ) . The total time of ischemia was significantly less in the IAC group with 37+/-10 vs. 48+/-10 min in the CA group . In the IAC-group , a higher mortality was noticed ( 7 . 7 vs. 3.9 % ; N.S. ) . This was combined with a significantly higher amount of patients with peak serum-values of CK-MB ( > 40 U/l ) and troponin I ( > 50 ng/ml ) , 17 in the IAC-group ( 33 % ) vs. eight in CA-group ( 16 % ) . Cerebral strokes were seen in two IAC- patients and none in CA- patients ( NS ) . ECG-changes occurred in 22 IAC patients ( 42 % ) vs. 16 CA patients ( 31 % ) ; persistent ischemia related ECG-changes in six IAC ( 11.5 % ) vs. five CA- patients ( 9.8 % ) . CONCLUSIONS Both cardioprotective methods , IAC and HTK-cardioplegia , seem to offer sufficient myocardial protection in normal CABG- procedures . Although neurologic disorders and mort
Output:
| No difference was identified in mortality ; there was a trend for increased incidence of ventricular fibrillation in the Custodiol group that did not reach statistical significance .
No difference was identified in studies that compared Custodiol with other solutions for heart transplant . |
MS211692 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objectives : The aim of this prospect i ve study was to assess the accuracy of 64-multidetector-row computed tomography coronary angiography ( CTA ) in the diagnosis of coronary artery disease ( CAD ) . Patients and Methods : Ninety-two patients suspected of having CAD underwent CTA using a 64-slice CT scanner before a scheduled , conventional coronary angiogram ( CCA ) . Blinded assessment of CTA to detect CAD was performed . The accuracy of CTA in detecting significant stenoses ( ≥50 % ) was compared to CCA . Data analysis was performed on 73 patients because the scans were nondiagnostic in 5 patients and 14 refused to undergo coronary angiography . Results : The CTAs of 21 of these 73 patients were considered as normal ; 19 were confirmed on CCA . For the remaining 52 diagnosed as abnormal , 51 were confirmed on CCA . For patient-based analysis , CTA had a sensitivity of 95 % , a specificity of 96 % , a positive predictive value of 98 % and a negative predictive value of 90 % . For the whole vessel , the sensitivity of CTA was 60–100 % , for all vessels and the specificity was 82–100 % . Pooled sensitivity was 92 % and pooled specificity was 98 % . For the segments , the sensitivity of CTA was 64 % or above for all vessels except for the distal left anterior descending artery ( 40 % ) , mid circumflex artery ( 50 % ) and posterior descending artery ( 60 % ) ; the pooled sensitivity was 79 % . The specificity for the segments was 82–100 % for all vessels and pooled specificity was 94 % . Conclusion : The sensitivity and specificity for patient-based analysis and for the main coronary vessels were high whereas for the segments , the sensitivity was moderately good , but the specificity was high , confirming that a negative CTA is useful to rule out significant CAD . A coordinated classification system between radiologists and cardiologists is required to eliminate errors in segment classification Background — Noninvasive coronary angiography with the use of multislice computed tomography ( CT ) scanners is feasible with high sensitivity and negative predictive value ; however , the radiation exposure associated with this technique is rather high . We evaluated coronary angiography using whole-heart 320-row CT , which avoids exposure-intensive overscanning and overranging . Methods and Results — A total of 30 consecutive patients with suspected coronary artery disease referred for clinical ly indicated conventional coronary angiography ( CCA ) were included in this prospect i ve intention-to-diagnose study . CT was performed with the use of up to 320 simultaneous detector rows before same-day CCA , which , together with quantitative analysis , served as the reference st and ard . The per-patient sensitivity and specificity for CT compared with CCA were 100 % ( 95 % confidence interval [ CI ] , 72 to 100 ) and 94 % ( 95 % CI , 73 to 100 ) , respectively . Per-vessel versus per-segment sensitivity and specificity were 89 % ( 95 % CI , 62 to 98 ) and 96 % ( 95 % CI , 90 to 99 ) versus 78 % ( 95 % CI , 56 to 91 ) and 98 % ( 95 % CI , 96 to 99 ) , respectively . Interobserver agreement between the 2 readers was significantly better for CCA ( 97 % of 121 coronary arteries ) than for CT ( 90 % ; P=0.04 ) . Percent diameter stenosis determined with the use of CT showed good correlation with CCA ( P<0.001 , R=0.81 ) without significant underestimation or overestimation ( −3.1±24.4 % ; P=0.08 ) . Intraindividual comparison of CT with CCA revealed a significantly smaller effective radiation dose ( median , 4.2 versus 8.5 mSv ; P<0.05 ) and amount of contrast agent required ( median , 80 versus 111 mL ; P<0.001 ) for 320-row CT . The majority of patients ( 87 % ) indicated that they would prefer CT over CCA for future diagnostic imaging ( P<0.001 ) . Conclusions — CT with the use of emerging technology has the potential to significantly reduce the radiation dose and amount of contrast agent required compared with CCA while maintaining high diagnostic accuracy Background —Both whole-heart magnetic resonance coronary angiography ( WH-MRCA ) and multidetector computed tomography ( MDCT ) have been proposed for the noninvasive identification of the coronary stenosis . The authors sought to directly compare the diagnostic accuracy of these noninvasive imaging techniques using the invasive quantitative coronary angiography as a reference st and ard . Methods and Results —Seventy-seven consecutive patients ( 56 men , 61±14 years ) prospect ively underwent WH-MRCA and 40- or 64-slice MDCT before the quantitative coronary angiography . Diagnostic accuracy of WH-MRCA and MDCT for the visual identification of > 50 % diameter stenosis in segments of > 1.5 mm size was compared using the quantitative coronary angiography as a reference . According to the quantitative coronary angiography , 49 of 992 coronary segments > 1.5 mm diameter had > 50 % diameter stenosis . MDCT had a higher success rate ( 100 % versus 88 % , P<0.001 ) and enabled identification of more segments ( 963 versus 726 , P<0.001 ) than did WH-MRCA . On a per-segment basis , WH-MRCA had similar sensitivity ( 47/49 or 96 % versus 48/49 or 98 % , P=0.9 ) but significantly lower specificity ( 644/943 or 68 % versus 863/943 or 92 % , P<0.001 ) and accuracy ( 691/992 or 70 % versus 911/992 or 92 % , P<0.001 ) for the detection of > 50 % diameter stenosis than did MDCT . On a per-patient basis , the sensitivity was similar ( 17/17 or 100 % versus 16/17 or 94 % , P=0.9 ) , but specificity ( 43/60 or 72 % versus 53/60 or 88 % , P=0.024 ) and diagnostic accuracy ( 60/77 or 78 % , versus 69/77 or 90 % , P=0.044 ) of WH-MRCA for the detection of > 50 % diameter stenosis were significantly lower than of MDCT . Conclusions —Because of the higher success rate and higher number of interpretable segments , 40- or 64-slice MDCT performs better than WH-MRCA OBJECTIVES The aim of this study was to compare the diagnostic performance of multidetector computed tomography ( MDCT ) with prospect i ve electrocardiogram ( ECG ) triggering versus retrospective ECG triggering . BACKGROUND MDCT allows the noninvasive visualization of the coronary arteries . However , radiation exposure is a reason for concern . METHODS One hundred eighty consecutive patients scheduled for invasive coronary angiography were enrolled in this study . Twenty patients were excluded due to contraindications to sustain MDCT . Of the 160 remaining patients , 80 were studied with MDCT with prospect i ve ECG triggering ( Group 1 ) and 80 with a retrospective ECG triggering ( Group 2 ) . The individual radiation dose exposure was estimated . RESULTS In nonstented segments , the evaluability of Groups 1 and 2 was 96 % versus 97 % , respectively ( p = 0.05 ) , the accuracy in segment-based model was 93 % versus 96 % , respectively ( p < 0.05 ) including diagnostic segments and 91 % versus 94 % , respectively ( p < 0.01 ) including all segments , whereas the accuracy in a patient-based model was 98 % in both groups . In stented segments the evaluability in Groups 1 and 2 was 92 % versus 94 % , respectively , and the accuracy was 93 % versus 92 % , respectively , including diagnostic stented segments and 90 % versus 89 % , respectively , including all stented segments . Group 1 presented lower radiation dose compared with Group 2 ( 5.7 + /- 1.5 mSv vs. 20.5 + /- 4.3 mSv , p < 0.01 ) . CONCLUSIONS Prospect i ve ECG-triggering computed tomography allows an accurate detection of coronary stenosis , despite a slight reduction of diagnostic performance , with a low radiation dose Objective : To investigate the performance of low-dose , dual- source computed tomography ( DSCT ) coronary angiography in the step- and -shoot ( SAS ) mode for the diagnosis of significant coronary artery stenoses in comparison with conventional coronary angiography ( CCA ) . Design , setting and patients : Prospect i ve , single-centre study conducted in a referral centre enrolling 120 patients ( 71 men , mean ( SD ) age 68 ( 9 ) years , mean ( SD ) body mass index 26.2 ( 3.2 ) kg/m2 ) . All study participants underwent DSCT in the SAS mode and CCA within 14 days . Twenty-seven patients were given intravenous β blockers for heart rate reduction before CT . Patients were excluded if a target heart rate ⩽70 bpm could not be achieved by β blockers or when the patients were in non-sinus rhythm . Two blinded readers independently evaluated coronary artery segments for assessability and for the presence of significant ( > 50 % ) stenoses . Sensitivity , specificity , negative ( NPV ) and positive predictive values ( PPV ) were determined , with CCA being the st and ard of reference . Radiation dose values were calculated . Results : DSCT coronary angiography in the SAS mode was successfully performed in all 120 patients . Mean ( SD ) heart rate during scanning was 59 ( 6 ) bpm ( range 44–69 ) . 1773/1803 coronary segments ( 98 % ) were depicted with a diagnostic image quality in 109/120 patients ( 91 % ) . The overall patient-based sensitivity , specificity , PPV and NPV for the diagnosis of significant stenoses were 100 % , 93 % , 94 % and 100 % , respectively . The mean ( SD ) effective dose of the CT protocol was 2.5 ( 0.8 ) mSv ( range 1.2–4.4 ) . Conclusions : DSCT coronary angiography in the SAS mode allows , in selected patients with a regular heart rate , the accurate diagnosis of significant coronary stenoses at a low radiation dose OBJECTIVE The purpose of this study was to prospect ively evaluate the effects of mean heart rate and heart rate variability on image quality at coronary 64-MDCT angiography of patients with atrial fibrillation and to determine the efficacy of coronary 64-MDCT angiography in the detection of significant ( > 50 % ) coronary artery stenosis in patients with atrial fibrillation . SUBJECTS AND METHODS Sixty patients ( 37 women , 23 men ; mean age , 58.7 years ) underwent both coronary 64-MDCT angiography and conventional coronary angiography . Heart rate variability was calculated as the SD from the mean heart rate during scanning . Image quality ( good , moderate , or poor ) and the presence of significant ( > 50 % ) stenosis at coronary CT angiography were evaluated by two radiologists blinded to the results of conventional coronary angiography . The sensitivity , specificity , positive predictive value , and negative predictive value of coronary CT angiography were calculated with conventional angiography as the reference st and ard . Pearson 's correlation analysis and chi-square tests were performed to compare image quality with mean heart rate and heart rate variability in each patient . Differences in detection of coronary artery stenosis between coronary 64-MDCT angiography and conventional coronary angiography were evaluated with McNemar 's test , and agreement between techniques was calculated with kappa statistics . RESULTS The mean heart rate was 90 + /- 13.1 beats/min with variability of 19.35 + /- 6.95 beats/min . Of 803 segments evaluated , 26 ( 3 % ) were considered to have poor image quality . Highly significant correlation was found between mean heart rate and image quality for all segments in each patient ( r = 0.51 , p < 0.001 ) , for the right coronary artery ( r = 0.43 , p = 0.001 ) , and for the distal portion of the coronary arteries ( r = 0.50 , p < 0.001 ) . Heart rate variability also correlated in a highly significant way with image quality in all segments ( r = 0.57 , p < 0.001 ) , the right coronary artery ( r = 0.46 , p < 0.001 ) , and the middle ( r = 0.44 , p = 0.001 ) and distal ( r = 0.41 , p = 0.001 ) portions of the coronary arteries . The best diagnostic image quality was obtained in end systole ( 200 - 400 milliseconds ) . Image quality decreased significantly with a mean heart rate greater than 100 beats/min or with an SD of heart rate greater than 24 beats/min . The overall sensitivity , specificity , positive predictive value , and negative predictive value per segment level were 86.4 % ,
Output:
| Furthermore , pooled analysis revealed that each QUADAS item that is not fulfilled has the potential to change estimates of diagnostic accuracy .
Conclusions The method ological quality of studies investigating the diagnostic accuracy of non-invasive coronary CT is only moderate and was found to affect the sensitivity and specificity .
Weak method ological quality will affect the sensitivity and specificity .
• No improvement in method ological quality was observed over time . • |
MS211693 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: A double-blind clinical trial was conducted on 30 female Temporom and ibular Disorders ( TMD ) patients who had pain as a chief complaint . The patients were r and omly allocated into three groups based on Low Intensity Laser ( LILT ) regimes namely 820 nm Gallium Aluminium Arsenide ( GaAlAs ) laser at energy densities of 21.4J/cm(2 ) , 107 J/cm(2 ) and placebo laser . Each patient had three LILT treatments in a week . The pressure pain threshold ( PPT ) of trigger points in masticatory muscles , unassisted maximum mouth opening without pain ( MOSP ) and symptom severity index ( SSI ) were recorded as baseline data and monitored after every treatment . Jaw kinesiology , electromyography ( EMG ) and pain rating index from McGill pain question naire were also recorded as baseline and final results . The analysis of covariance and further analysis showed that the higher energy density laser group had significant increases in PPT and EMG amplitude recorded from voluntary clenching ( cEMG ) compared with the placebo group at P values 0.0001 and 0.022 respectively . A significantly greater number of patients recovered from myofascial pain and TMJ arthralgia as assessed clinical ly in the higher energy group compared with the placebo ( P value = 0.02 and 0.006 respectively ) . There was no statistically significant difference in the other parameters of assessment among the groups at a P value 0.05 . At a period of 2 to 4 weeks review after LILT , there was an average 52 % reduction of pain as assessed by SSI Abstract Aims : This study investigated the efficacy of low-level laser therapy ( LLLT ) for the management of temporom and ibular joint ( TMJ ) osteoarthritis . Methodology : In a double-blind clinical trial , 20 patients with TMJ osteoarthritis were r and omly divided into laser and placebo groups . The patients in the laser group received irradiation from an 810 nm low-level laser ( Peak power 80 W , average power 50 mW , 1500 Hz , 1 μs pulse width , 120 seconds , 6 J , 3·4 J/cm2 per point ) , which was applied on four points around the TMJs and on painful muscles three times a week for 4 weeks . In the placebo group , the treatment was the same as that in the laser group , but with laser simulation . The patients were evaluated before laser therapy ( T1 ) , after 6 ( T2 ) and 12 ( T3 ) laser applications and 1 month after the last application ( T4 ) , and the amount of mouth opening and the pain intensity were recorded . Results : No significant differences were found in mouth opening either between the study groups or between the different evaluation times in each group ( P>0·05 ) . There was no significant difference in pain symptoms of the masticatory muscles and TMJ between the laser and the placebo groups ( P>0·05 ) , but some significant within-group improvements were present for Visual Analogue Scale ( VAS ) scores of the body of the masseter and TMJ in both groups . Conclusions : LLLT using the present laser parameters was no more effective than the placebo treatment for reducing pain and improving mouth opening in patients with TMJ osteoarthritis Background To evaluate the effect of Low Level Laser ( LLL ) application at the points of greatest pain in patients with chronic masticatory muscle pain . Methods A total number of 30 ( 21 women , 9 men , with a mean age of 39.2 ) were selected after the diagnosis of MPDS according to the Research Diagnostic Criteria for Temporom and ibular Disorder ( RDC/TMD ) . The patients were r and omly divided into three groups ; laser group I ( n = 10 ) ; patients received the LLL at the point of greatest pain , laser group II ( n = 10 ) ; patients received LLL at pre-established points in the effected muscles and placebo group ( n = 10 ) . LLL and placebo were applied three times per week , for a total of 12 sessions . M and ibular mobility was examined , masticator muscles tenderness were assessed and PPT values were obtained . Subjective pain levels were evaluated using VAS . The measurements performed before the treatment and after the completion of the therapy . Descriptive statistics ( mean , st and ard deviation , and frequency ) Student ’s t-test , Mann – Whitney U-test and paired- sample t-tests were used for analysis . Results In both laser groups , there was a statically significant reduction in PPT values of the muscles , number of muscles without any pain on palpation increased significantly , m and ibular movements ’ ranges were improved . Laser group I demonstrated statistically better results than the Laser group II in all of the measured values . Plasebo group did not show any statistically difference in any of the measured values . Conclusions LLLT can be accepted as an alternative treatment modality in the management of masticatory muscle pain and direct irradiation seems to effect better . Trial registration Current Controlled Trials IS RCT N31085 , Date of registration 28/08/20145 The purpose of this study was to assess the effect of low level laser therapy on subjects with intra-articular temporom and ibular disorders ( IA-TMD ) , and to quantify and compare severity of signs and symptoms before , during , and after the laser applications . The sample consisted of 45 subjects r and omly divided into three groups ( G ) of 15 subjects each : G-I : 15 individuals with IA-TMD su bmi tted to an energy dose of 52.5 J/cm2 ; G-II : dose of 105.0 J/cm2 ; and G-III : placebo group ( 0 J/cm2 ) . In all groups , the applications were performed on condylar points on the masseter and anterior temporalis muscles . Two weekly sessions were held for five weeks , totaling 10 applications . The assessed variables were : m and ibular movements and painful symptoms evoked by muscle palpation . These variables were measured before starting the study , then immediately after the first , fifth , and tenth laser application , and finally , 32 days after completing the applications . The results showed that there were statistically significant differences for G-I and G-II at the level of 1 % between the doses , as well as between assessment s. Therefore , it was concluded that the use of low level laser increased the mean m and ibular range of motion and reduced painful symptoms in the groups that received effective treatment , which did not occur in the placebo group The aim of this study was to evaluate different approaches to deactivating myofascial trigger points ( MTPs ) . Twenty-one women with bilateral MTPs in the masseter muscle were r and omly divided into three groups : laser therapy , needle treatment and control . Treatment effectiveness was evaluated after four sessions with intervals ranging between 48 and 72 h. Quantitative and qualitative methods were used to measure pain perception/sensation . The Wilcoxon test based on results expressed on a visual analog scale ( VAS ) demonstrated a significant ( P < 0.05 ) decrease in pain only in the laser and needle treatments groups , although a significant increase in the pressure pain threshold was evident only for needling with anesthetic injection ( P = 0.0469 ) , and laser therapy at a dose of 4 J/cm² ( P = 0.0156 ) . Based on these results , it was concluded that four sessions of needling with 2 % lidocaine injection with intervals between 48 and 72 h without a vasoconstrictor , or laser therapy at a dose of 4 J/cm² , are effective for deactivation of MTPs Objective : To investigate the effectiveness of low‐level laser therapy in the treatment of temporom and ibular disorder and to compare treatment effects in myogenic and arthrogenic cases . Methods : Thirty‐five patients were evaluated by magnetic resonance imaging and r and omly allocated to active treatment ( n=20 ) and placebo treatment ( n=15 ) groups . In addition to a daily exercise program , all patients were treated with fifteen sessions of low‐level laser therapy . Pain , joint motion , number of joint sounds and tender points were assessed . Results : Significant reduction in pain was observed in both active and placebo treatment groups . Active and passive maximum mouth opening , lateral motion , number of tender points were significantly improved only in the active treatment group . Treatment effects in myogenic and arthrogenic cases were similar . Conclusion : Low‐level laser therapy can be considered as an alternative physical modality in the management of temporom and ibular disorder Purpose : The aim of this systematic review was to assess the efficacy of low-level laser therapy ( LLLT ) in patients with temporom and ibular disorders ( TMDs ) . Methods : Medline search was done from 1997 to 2011 using search terms appropriate to establishing a relation between LLLT and TMD . Only r and omized controlled trials were included in this study . Outcome variables related to pain , muscle tenderness , m and ibular movements , and Electromyographic ( EMG ) activity were considered . Of the 242 articles examined , 13 were finally included in the critical analysis conducted as a part of the present systematic review . Results : Of the 242 titles review ed , only 13 articles were considered eligible . 7 articles showed significant improvement in the study group , whereas 5 showed no significant improvement between the study and control groups . The primary outcome of most of the studies was pain . Other variables considered were muscle tenderness , m and ibular movements ; EMG activity was considered . Conclusion : Our results have shown that LLLT seems to be effective in reducing pain in TMD 's . It may be a treatment option for patients with an interest in a noninvasive , complementary therapy This study aim ed to evaluate the effectiveness of low intensity laser therapy ( LILT ) in 30 patients presenting temporom and ibular joint ( TMJ ) pain and m and ibular dysfunction in a r and om and double-blind research design . The sample , divided into experimental group ( 1 ) and placebo group ( 2 ) , was su bmi tted to the treatment with infrared laser ( 780 nm , 30 mW , 10 s , 6.3 J/cm(2 ) ) at three TMJ points . The treatment was evaluated throughout six sessions and 15 , 30 and 60 days after the end of the therapy , through visual analogue scale ( VAS ) , range of m and ibular movements and TMJ pressure pain threshold . The results showed a reduction in VAS ( p < 0.001 ) and through the ANOVA with repeated measures it was observed that the groups did not present statistically significant differences ( P = 0.2060 ) , as the averages of the evaluation times ( P = 0.3955 ) and the interaction groups evaluation times ( P = 0.3024 ) , considering the MVO . The same occurred for RLE ( P = 0.2988 , P = 0.1762 and P = 0.7970 ) , LLE ( P = 0.3265 , P = 0.4143 and P = 0.0696 ) , PPTD ( P = 0.1558 , P = 0.4695 and P = 0.0737 ) and PPTE ( P = 0.2376 , P = 0.3203 and P = 0.0624 ) . For PE , there were not statistically significant differences for groups ( P = 0.7017 ) and the interaction groups evaluation times ( P = 0.6678 ) , even so in both groups the PE varied with time ( P = 0.0069 ) The present study was design ed to evaluate the effects of low-level laser ( Nd : YAG ) therapy and occlusal splints in patients with signs and symptoms of temporom and ibular disorders ( TMD ) characterized with myofascial pain ( MP ) . A total of 30 patients were selected after being diagnosed with MP according to the Research Diagnostic Criteria for Temporom and ibular Disorders ( RDC/TDM ) . The patients were divided into three groups . The first group was occlusal splint ( OS ) group A ( n = 10 ) , the second was low-level laser therapy ( LLLT ) group B ( n = 10 ) , and the last group C was placebo ( n = 10 ) . LLLT ( 1,064 nm , 8 j/cm2 , 250 mW , Fotona ) was applied to the patients in the study group once a day for 10 days , for a total of ten sessions . The same parameters and application times were used for placebo group , but the patients were not irradiated . The application was on the trigger points . The patients in the OS group were instructed to wear occlusal splints 12 h/day for 3 weeks . Functional examination was based on RDC/TDM , and pressure pain values were obtained with the Visual Analog Scale . Comparisons were made between the groups before and after the treatment according to Wilcoxon , Mann – Whitney U , and Kruskal – Wallis tests . The pain score values decreased significantly after both LLLT ( p < 0.05 ) and occlusal splint therapy ( p < 0.05 ) compared to placebo group ( p < 0.05 ) . There was no significant difference between LLLT and OS groups after treatment ( p > 0.05 ) . OS and LLLT are effective for decreasing MP . In addition , this particular type of LLLT is as effective as occlusal splint for pain relief AIMS To evaluate the effectiveness of low-level laser therapy ( LLLT ) in patients presenting with temporom and ibular disorder ( TMD ) in a r and om and placebo-controlled research design . METHODS The sample consisted of 40 patients , divided into an experimental group ( G1 ) and a placebo group ( G2 ) . The treatment was done with an infrared laser ( 830 nm , 500mW , 20s , 4J/point ) at the painful points , once a
Output:
| Combining data from all clinical ly heterogeneous studies revealed positive effects of LLLT on pain relief , regardless of the visual analogue scale ( VAS ) score or the change of VAS score between the baseline and the final follow-up time point , while dosage analyses showed discrepant results about the effects of high or low doses for patients with TMD .
Follow-up analyses showed that LLLT significantly reduced pain at the short-term follow-up .
Temporom and ibular joint function outcomes indicated that the overall effect favored LLLT over placebo .
Conclusion This systematic review suggests that LLLT effectively relieves pain and improves functional outcomes in patients with TMD |
MS211694 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE It is unclear if any catheterisation is necessary after vaginal surgery for pelvic organ prolapse . The aim of this study was to determine if indwelling catheterisation is necessary after these procedures . STUDY DESIGN A r and omised controlled trial of immediate post-operative removal of catheter compared to a suprapubic catheter ( SPC ) after vaginal prolapse surgery . In the Suprapubic group the catheter was left on free drainage until a voiding trial was commenced at 48h . Women in the immediate removal group underwent in/out catheterisation only if they had not voided by 8h after surgery to ensure the bladder did not over-distend . RESULTS 55 % ( n=17 ) of patients in the immediate removal group did not require catheterisation postoperatively . A further 13 ( 42 % ) patients only required one in/out catheterisation 8h post operatively . In the immediate removal group duration of catheterisation was significantly shorter ( median 0h , IQR 0 - 8h , range 0 - 16h ) vs ( 6days ( IQR 2 - 8days , range 2 - 19h ) p=0.001 ) . The duration of hospital stay ( 7days ( range 3 - 16 ) vs. 9 ( range 3 - 27 ) p=0.014 ) , day of first mobilisation ( Day 1 , range 0 - 2 , vs. Day 2 , range 1 - 4 , p=0.001 ) , and rate of Symptomatic bacturia ( 16 % vs. 52 % , p<0.01 ) were all significantly better with immediate catheter removal . CONCLUSIONS After vaginal surgery for pelvic organ prolapse , the majority of patients do not require extended catheterisation . Early removal of a catheter reduces urinary tract infection and significantly decreases hospital stay . Such a policy should result in improved patient satisfaction and reduced hospital costs In a prospect i ve study the results of postoperative urinary discharge by suprapubic catheterisation ( SC ) are compared with those of transurethral catheterisation ( TC ) in a r and omised collective of gynaecological patients after vaginal hysterectomy with front ( resp . front and back ) plastic . During November 1979 and September 1980 157 patients were examined , 88 patients by suprapubic catheterisation and 69 by transurethral catheterisation , with r and om distribution . Additionally , 430 other patients with suprapubic aspiration after vaginal hysterectomy with front and /or back plastic performed between September 1980 and October 1982 were examined retrospectively especially under the aspect of possible complications . The advantages of suprapubic urinary discharge are shown in the significantly reduced rate of primary infections . 20.5 per cent of infections are opposed to 67.1 per cent in the comparative group with TC . Spontaneous miction was possible in the SC group two days earlier than in the group of TC ( 5.2 days opposed to 7.35 days ) . Additional drug treatment for restitution of the bladder function was more often necessary for patients with TC , although the results with 43.5 per cent against 29.5 per cent in the SC collective are not significant . The number of renewed catheterisations after removal of the catheter was higher by 27 per cent in the group of patients with SC . Subjective complaints were stated by patients with TC in 66.7 per cent against 18.2 per cent of women with SC . This result is significant . In the TC collective there were significantly more patients with leucocyturia ( 88.5 per cent against 48.7 per cent ) . Antibiotic treatment of an urinary tract infection with typical symptoms was necessary in 35.8 per cent for patients with TC and in 14.1 per cent for women with SC . ( ABSTRACT TRUNCATED AT 250 WORDS We surveyed the extensive literature regarding the development , therapy and prevention of catheter-associated urinary tract infections ( UTIs ) . We systematic ally search ed for meta-analyses of r and omised controlled trials available in Medline giving preference to the Cochrane Central Register of Controlled Trials and also considered other relevant publications , rating them on the basis of their quality . The studies ’ recommendations , rated according to a modification of the US Department of Health and Human Services ( 1992 ) , give a close-to- evidence based guideline for all medical disciplines , with special emphasis on urology where catheter care is an important issue . The survey found that the urinary tract is the commonest source of nosocomial infection , particularly when the bladder is catheterised ( IIa ) . Most catheter-associated UTIs are derived from the patient ’s own colonic flora ( IIb ) and the catheter predisposes to UTI in several ways . The most important risk factor for the development of catheter-associated bacteriuria is the duration of catheterisation ( IIa ) . Most episodes of short-term catheter-associated bacteriuria are asymptomatic and are caused by a single organism ( IIa ) . Further organisms tend to be acquired by patients catheterised for more than 30 days . The clinician should be aware of two priorities : the catheter system should remain closed and the duration of catheterisation should be minimal ( A ) . While the catheter is in place , systemic antimicrobial treatment of asymptomatic catheter-associated bacteriuria is not recommended ( A ) , except for some special cases . Routine urine culture in an asymptomatic catheterised patient is also not recommended ( C ) because treatment is in general not necessary . Antibiotic treatment is recommended only for symptomatic infection ( B ) . Long-term antibiotic suppressive therapy is not effective ( A ) . Antibiotic irrigation of the catheter and bladder is of no advantage ( A ) . Routine urine cultures are not recommended if the catheter is draining properly ( C ) . A minority of patients can be managed with the use of the non-return ( flip ) valve catheter , avoiding the closed drainage bag . Such patients may exchange the convenience of on-dem and drainage with an increased risk of infection . Patients with urethral catheters in place for 10 years or more should be screened annually for bladder cancer ( C ) . Clinicians should always consider alternatives to indwelling urethral catheters that are less prone to causing symptomatic infection . In appropriate patients , suprapubic catheters , condom drainage systems and intermittent catheterisation are each preferable to indwelling urethral catheterisation ( B ) Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Abstract . Ninety‐two patients with preoperative sterile urine undergoing colposuspension or vaginal repair operation for stress urinary incontinence and /or genital descensus were r and omized to either suprapubic or transurethral postoperative catheter drainage . The prevalence of significant bac‐teriuria on the fifth postoperative day was statistically significantly lower when using suprapubic catheter ( 20.8 % ) than with transurethral catheter drainage ( 45.5 % ) . This applied especially to colposuspension . The rate of postoperatively impaired bladder emptying also tended to be reduced when using suprapubic catheter . At follow‐up after one year , postoperative bacteriuria was closely correlated to increased rates of both clinical cystitis and asymptomatic significant bacteriuria . Thus it is recommended to use suprapubic bladder drainage not only after colposuspension but also after vaginal repair in an effort to avoid an increased risk of urinary infections Introduction and hypothesisDifferent forms of urinary drainage are applied after anterior colporrhaphy . Suprapubic urinary catheter ( SUC ) and indwelling urinary catheter ( IUC ) for 2 to 96 h are preferred . If there is no difference in symptomatic urinary tract infection ( SUTI ) or complications between IUCs for 96 and 24 h , the latter will be considered sufficient . If IUCs have no higher rate of infections or complications compared to SUC for 96 h , the former could be considered sufficient . Methods It was a three-arm prospect i ve , r and omized study including 257 patients . The three arms were : IUCs for 24 h , IUCs for 96 h , and SUCs for 96 h. Results We found no significant difference in SUTIs between all three groups . Although the SUC arm showed no SUTIs , a significant higher rate of complications was seen . Conclusion The optimal bladder catheter after anterior colporrhaphy was , in our trial , the IUC for 24 A controversy exists concerning the most appropriate method of bladder drainage after vaginal hysterectomy and anterior-posterior repair . The present study compares the use of the Foley catheter and the suprapubic tube following these operations . One hundred and fifty suitable c and i date s were selected , with 75 using each system . The results showed that the suprapubic group had one-third the rate { 12 % vs 38 % ) of significant bacteriuria when compared to the Foley group at the time the instruments were removed on the fourth postoperative day . In addition the Foley group also had a significant increase in the number of positive urine cultures 6 weeks after the operation ( 10 % vs 2 % ) , a higher incidence of prolonged hospitalization ( greater than 6 days ) , and a more frequent use of bladder analgesics ( 69 % vs 41 % ) . Other advantages in the use of suprapubic tubes after vaginal surgery appeared to be ease of care by ward personnel , greater patient comfort , and a reduced incidence of severe complications . An additional finding of this study was related to the increase of significant bacteriuria in patients receiving cold knife conization prior to hysterectomy . This factor appeared to be constant regardless of the drainage system used although a greater number of cases were found in the Foley group OBJECTIVE To determine the potential benefits of ISC ( intermittent self-catheterisation ) over SPC ( supra-pubic catheterisation ) in the post-operative bladder care of women following radical hysterectomy . METHODS A prospect i ve r and omised controlled trial of women treated by radical hysterectomy for early stage cervical cancer . RESULTS . : 40 women were recruited to the study , 21 to ISC and 19 to SPC . All patients r and omised to ISC were able to learn the technique of ISC satisfactorily following a period of pre-operative training . The day 3 and day 5 positive CSU ( catheter specimen of urine ) rate was significantly higher in the ISC group ( 42 % and 63 % ) compared to the SPC group ( 6 % and 18 % ) , P = 0.05 and P = 0.004 , respectively ) . Eight of 17 patients r and omised to SPC ( 47 % ) documented having symptoms/problems arising from the SPC site of which 4 ( 23 % ) were shown to have a positive wound swab . There was no significant difference in length of period for bladder care between the two groups , P = 0.83 . However , there were significant differences in patient acceptability ( P = 0.009 ) , freedom to lead a normal life ( P = 0.000 ) , disturbance at night ( P = 0.006 ) and patient anxiety/embarrassment ( P = 0.005 ) between the two groups . CONCLUSIONS Patients are able to learn the technique of ISC without difficulty . Despite a greater urinary tract infection rate , the high incidence of SPC site problems can be avoided by use of ISC . The technique of ISC was seen to be more acceptable to patients allowing fewer disturbances at night , greater freedom to lead a normal life during the day and less anxiety/embarrassment compared to SPC In a prospect i ve r and omized study comprising 90 women undergoing vaginal plastic surgery , suprapubic and transurethral catheter drainage of the bladder were compared regarding urinary tract infection and asymptomatic bacteriuria . No statistically significant differences were found . The mean duration of catheterization was 4.9 days for suprapubic vs 3.3 days for transurethral catheter patients . Postoperative urinary tract infection was diagnosed in 23.7 % of patients with suprapubic and in 27.5 % of patients with transurethral catheters . Asymptomatic bacteriuria at catheter removal was found in 21.0 % of suprapubic and in 12.5 % of transurethral catheter patients . More mechanical complications were seen with SPCsthan with TUCs . It is concluded that the two methods involve similar risks of infectious complications but that SPCs have a higher rate of mechanical complications OBJECTIVE To compare the use of intermittent urethral catheterization with indwelling suprapubic catheterization in women undergoing surgery for urodynamic stress incontinence or uterovaginal prolapse . DESIGN R and omized controlled trial . SETTING Tertiary referral urogynaecology unit . POPULATION Women undergoing surgery for pelvic organ prolapse and /or stress urinary incontinence . METHODS Women were r and omized into one of two groups . Group 1 had bladder drainage using a suprapubic catheter inserted in theatre . The catheter was left on free drainage for 48 hours post-operatively before clamping . Group 2 was catheterized intermittently post-operatively . MAIN OUTCOME MEASURES Length of post-operative
Output:
| No difference was found in other aspects ( complication rate and catheter-related pain ) among the three drainage routes .
Conclusions This meta- analysis suggested that suprapubic drainage was superior to indwelling urethral catheterization in reduction of asymptomatic bacteriuria and rate of recatheterization but was associated with higher rate of hematuria .
Intermittent catheterization was associated with a reduction in symptomatic UTI compared with indwelling urinary catheterization . |
MS211695 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE This study aim ed to investigate carbohydrate ( CHO ) mouth rinse response on neuromuscular activity , fuel oxidation rates , and cycling performance with different initial levels of endogenous CHO availability . METHODS In a double-blind , r and omized placebo-controlled design , eight males completed six experimental mouth rinse trials : CHO ( 6.4 % maltodextrin ) or placebo solution in a fed state ( FED ) , 12-h fasted state ( FAST ) , or a combined exercise-depleted muscle glycogen and 12-h fasted state ( DEP ) . Trials consisted of 30-min cycling at 90 % of gas exchange threshold , followed by a 20-km cycling time trial . Plasma lactate , plasma glucose , oxygen uptake , and EMG activity were measured , and CHO and fat oxidation rates were calculated . RESULTS CHO mouth rinse maintained higher plasma glucose levels as the constant load exercise progressed ( P = 0.023 ) . The reduced EMG activity in the DEP condition with the placebo during constant load exercise was ameliorated with CHO mouth rinse ( P < 0.01 ) . Furthermore , the power output and the EMG activity throughout the 20-km time trial were reduced in the DEP condition with placebo but were both restored with CHO mouth rinse ( P < 0.05 ) . Time trial performance was only improved with CHO in the DEP compared with the corresponding placebo ( P < 0.05 ) , and no differences between supplements were observed in the FED or FAST states . Analyses of the qualitative inference showed " benefit very likely " of CHO mouth rinse on exercise performance in DEP , " possibly benefit " in FAST , and " negligible or trivial " in FED . CHO mouth rinse had no effect on CHO and fat oxidation rates in either exercise mode . CONCLUSION The CHO mouth rinse influences exercise performance when endogenous CHO availability is low , and an enhanced central motor drive is potentially the main influencing mechanism The carbohydrate ( CHO ) concentration of a mouth rinsing solution might influence the CHO sensing receptors in the mouth , with consequent activation of brain regions involved in reward , motivation and regulation of motor activity . The purpose of the present study was to examine the effects of maltodextrin mouth rinsing with different concentrations ( 3 % , 6 % and 12 % ) after an overnight fast on a 20 km cycling time trial performance . Nine recreationally active , healthy males ( age : 24 ± 2 years ; V˙O2max : 47 ± 5 mL·kg−1·min−1 ) participated in this study . A double-blind , placebo-controlled r and omized study was conducted . Participants mouth-rinsed every 2.5 km for 5 s. Maltodextrin mouth rinse with concentrations of 3 % , 6 % or 12 % did not change time to complete the time trial and power output compared to placebo ( p > 0.05 ) . Time trial completion times were 40.2 ± 4.0 , 40.1 ± 3.9 , 40.1 ± 4.4 , and 39.3 ± 4.2 min and power output 205 ± 22 , 206 ± 25 , 210 ± 24 , and 205 ± 23 W for placebo , 3 % , 6 % , and 12 % maltodextrin conditions , respectively . Heart rate , lactate , glucose , and rating of perceived exertion did not differ between trials ( p > 0.05 ) . In conclusion , mouth rinsing with different maltodextrin concentrations after an overnight fast did not affect the physiological responses and performance during a 20 km cycling time trial in recreationally active males The presence of carbohydrate in the mouth can immediately improve physical performance . How this occurs is not well understood . Here we used transcranial magnetic stimulation of primary motor cortex ( M1 ) to investigate the effects of non-sweet carbohydrate on corticomotor excitability and voluntary force production . In Experiment 1 , 16 participants performed a fatiguing isometric elbow flexion exercise for 30 min , and Motor evoked potentials ( MEPs ) were recorded from the biceps brachii during maximal voluntary force ( MVF ) produced every 2 min . After 11 min participants drank a carbohydrate solution ( CHO ) or an energy-free placebo solution ( PLA ) , in a double-blind , cross-over protocol . MEP amplitude increased by 30 % , and MVF increased by 2 % , immediately after carbohydrate ingestion . There was no relationship between the facilitation of MEP amplitude and plasma glucose or magnitude of fatigue . In a control experiment , 17 participants alternately mouth-rinsed CHO and PLA , in a r and omized , double-blind protocol . MEPs were recorded from right first dorsal interosseous at rest or during isometric contraction . MEP amplitude increased by 9 % with CHO , when the muscle was voluntarily activated . In both experiments , there were no effects on silent period duration , indicating that MEP facilitation was not due to reduced inhibition within M1 . This is the first demonstration that carbohydrate in the mouth immediately increases the excitability of the corticomotor pathway , prior to its ingestion . Afference from oral receptors is integrated with descending motor output , perhaps via nuclei in the brainstem . This novel form of sensorimotor integration facilitates corticomotor output to both fatigued and fresh muscle BACKGROUND Carbohydrates ( CHO ) are among the most investigated nutritional ergogenic aids , and may be consumed in different forms , e.g. , mouth rinse with carbohydrate solution ( MRCS ) . In this sense , the aim of this study was to evaluate the impact of MRCS on the performance of physically active individuals undergoing a physical exercise session carried out until the volitional exhaustion . METHODS This is a counter-balanced r and omized study , with a double-blind design . The sample consisted of twenty-one physically active healthy men with a mean ( ±SD ) of age of 22.4 ( ±2.7 ) years old , 76.7 ( ±6.0 ) cm of height,12.1 % ( ±3.7 ) of body fat mass , and 23.9 ( ±2.4 ) kg/m2 of body mass index . After familiarizing the participants with the protocol ( cycle ergometer , with oral mouth rinse procedure ) and assessing the maximal lactate steady state the cycling exercise was performed until the volitional exhaustion in the following conditions : without mouth rinse ( CONTROL ) , PLACEBO and MRCS . RESULTS Time to reach exhaustion was statistically different ( P<0.0001 ) between conditions ( control : 43.0±27.5 minutes ; placebo : 57.4±30.6 minutes ; MRCS : 70.9±30.3 minutes ) . CONCLUSIONS The administration of MRCS was shown to be effective in improving cycling performance , increasing the time to exhaustion until the volitional exhaustion . Thus , the use of methodology proposed by the present study may help coaches and practitioners improve the performance of physically active young adults It is presently unclear whether the reported ergogenic effect of a carbohydrate ( CHO ) mouth rinse on cycling time-trial performance is affected by the acute nutritional status of an individual . Hence , the aim of this study was to investigate the effect of a CHO mouth rinse on a 60-min simulated cycling time-trial performance commenced in a fed or fasted state . Twelve competitive male cyclists each completed 4 experimental trials using a double-blinded Latin square design . Two trials were commenced 2 h after a meal that contained 2.5 g·kg(-1 ) body mass of CHO ( FED ) and 2 after an overnight fast ( FST ) . Prior to and after every 12.5 % of total time during a performance ride , either a 10 % maltodextrin ( CHO ) or a taste-matched placebo ( PLB ) solution was mouth rinsed for 10 s then immediately expectorated . There were significant main effects for both pre-ride nutritional status ( FED vs. FST ; p < 0.01 ) and CHO mouth rinse ( CHO vs. PLB ; p < 0.01 ) on power output with an interaction evident between the interventions ( p < 0.05 ) . The CHO mouth rinse improved mean power to a greater extent after an overnight fast ( 282 vs. 273 W , 3.4 % ; p < 0.01 ) compared with a fed state ( 286 vs. 281 W , 1.8 % ; p < 0.05 ) . We concluded that a CHO mouth rinse improved performance to a greater extent in a fasted compared with a fed state ; however , optimal performance was achieved in a fed state with the addition of a CHO mouth rinse Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more The aim was to investigate the influence of a carbohydrate ( CHO ) mouth rinse on the vastus lateralis ( VL ) and rectus femoris ( RF ) electromyographic activity ( EMG ) and time to exhaustion ( TE ) during moderate ( MIE ) and high-intensity cycling exercise ( HIE ) . Thirteen participants cycled at 80 % of their respiratory compensation point and at 110 % of their peak power output to the point of exhaustion . Before the trials and every 15 min during MIE , participants rinsed with the CHO or Placebo ( PLA ) solutions . The root mean square was calculated . CHO had no effect on the TE during HIE ( CHO : 177.3 ± 42.2 s ; PLA : 163.0 ± 26.7 s , p = 0.10 ) , but the TE was increased during MIE ( CHO : 76.6 ± 19.7 min ; PLA : 65.4 ± 15.2 min ; p = 0.01 ) . The EMG activity in the VL was higher than PLA at 30 min ( CHO : 10.5 % ± 2.6 % ; PLA : 7.7 % ± 3.3 % ; p = 0.01 ) and before exhaustion ( CHO : 10.3 % ± 2.5 % ; PLA : 8.0 % ± 2.9 % ; p = 0.01 ) with CHO rinsing . There was no CHO effect on the EMG activity of RF during MIE or for VL and RF during HIE . CHO mouth rinse maintains EMG activity and enhances performance for MIE but not for HIE Abstract Ispoglou , T , O'Kelly , D , Angelopoulou , A , Bargh , M , O'Hara , JP , and Duckworth , LC . Mouth rinsing with carbohydrate solutions at the postpr and ial state fail to improve performance during simulated cycling time trials . J Strength Cond Res 29(8 ) : 2316–2325 , 2015—Mouth rinsing with carbohydrate ( CHO ) solutions during cycling time trials results in performance enhancements ; however , most studies have used approximately 6 % CHO solutions . Therefore , the purpose of this study was to compare the effectiveness of mouth rinsing with 4 , 6 , and 8 % CHO solutions on 1-hour simulated cycling time trial performance . On 4 occasions , 7 trained male cyclists completed at the postpr and ial period , a set amount of work as fast as possible in a r and omized counterbalanced order . The subjects rinsed their mouth for 5 seconds , on completion of each 12.5 % of the trial , with 25 ml of a non-CHO placebo and 4 , 6 , and 8 % CHO solutions . No additional fluids were consumed during the time trial . Heart rate ( HR ) , ratings of perceived exertion ( RPE ) , thirst ( TH ) , and subjective feelings ( SF ) were recorded after each rinse . Furthermore , blood sample s were drawn every 25 % of the trial to measure blood glucose and blood lactate concentrations , whereas whole-body CHO oxidation was monitored continuously . Time to completion was not significant between conditions with the placebo , 4 , 6 , and 8 % conditions completing the trials in 62.0 ± 3.0 , 62.8 ± 4.0 , 63.4 ± 3.4 , and 63 ± 4.0 minutes , respectively . There were no significant differences between conditions in any of the variables mentioned above ; however , significant time effects were observed for HR , RPE , TH , and SF . Post hoc analysis showed that TH and SF of subjects in the CHO conditions but not in the placebo were significantly increased by completion of the time trial . In conclusion , mouth rinsing with CHO solutions did not impact 1-hour cycling performance in the postpr and ial period and in the absence of fluid intake . Our findings suggest that there is scope for further research to explore the activation regions of the brain and whether they are receptive to CHO dose , before specific recommendations for athletic population s are established . Consequently , mouth rinsing as a practical strategy for coaches and athletes is question able under specific conditions and should be carefully considered before its inclusion . Emphasis should be focused on appropriate dietary and fluid strategies during training and competition PURPOSE To investigate the influence of ingesting versus mouth rinsing a carbohydrate-electrolyte solution on 1-h running performance . METHODS After a 14- to 15-h fast , 10 endurance-trained male runners ( mean ± SD : VO2peak = 65.0 ± 4.4 mL·kg(-1)·min(-1 ) ) completed
Output:
| Conclusion The present systematic and meta-analytic review supports the notion that a carbohydrate mouth rinse has the potential to increase mean power output in cycling trials , despite showing no superiority over placebo in improving time to complete the trials |
MS211696 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background : Dexamethasone treatment is associated with an increased risk of cerebral palsy ( CP ) . Early hydrocortisone ( HC ) treatment may decrease the incidence of bronchopulmonary dysplasia ; however , the long-term effects are still under evaluation . Follow-up of r and omized studies concerning early HC treatment is essential to confirm the long-term safety . Objective : We hypothesized that early HC treatment in very preterm infants does not impair the neurologic outcome . Methods : We report follow-up data from a r and omized trial of early HC given for 10 days . Before the HC or placebo treatment , serum cortisol levels were measured . Receiver-operating characteristic was defined . Values below the median were classified as low endogenous cortisol and those above the median as high endogenous cortisol . A meta- analysis was performed . Results : Altogether 98 % of the 46 surviving infants participated in a follow-up study at a corrected age of 2 years . The growth characteristics were similar between the study groups . The developmental quotients ( DQs ) of the children with high endogenous cortisol and placebo treatment shortly after birth ( 100 ± 13 ) and those with low endogenous cortisol and HC ( 97 ± 7 ) were not lower than the DQs of the children with high endogenous cortisol and HC ( 92 ± 3 ) or low cortisol and placebo ( 96 ± 2 ) . According to a meta- analysis of three available trials ( 411 children ) , the rate of CP and survival without neurosensory or cognitive impairment was not influenced by HC . Conclusion : Early low-dose HC administration had no adverse effects at 2 years of age . Further studies are required to define the target group for neonatal HC We evaluated the neurodevelopment and growth of five‐ to seven‐year‐old children who had participated in a r and omised trial of early low‐dose hydrocortisone treatment to prevent bronchopulmonary dysplasia BACKGROUND . Low cortisol concentrations in premature infants have been correlated with increased severity of illness , hypotension , mortality , and development of bronchopulmonary dysplasia . A total of 360 mechanically ventilated infants with a birth weight of 500 to 999 g were enrolled in a r and omized , multicenter trial of prophylaxis of early adrenal insufficiency to prevent bronchopulmonary dysplasia . Mortality and bronchopulmonary dysplasia were decreased in the hydrocortisone-treated patients exposed to chorioamnionitis . We now report outcomes at 18 to 22 months ' corrected age . PATIENTS AND METHODS . Surviving infants were evaluated with st and ardized neurologic examination and Bayley Scales of Infant Development-II . Neurodevelopmental impairment was defined as a Mental Developmental Index or Psychomotor Developmental Index of < 70 , cerebral palsy , blindness or deafness . RESULTS . A total of 252 ( 87 % ) of 291 survivors were evaluated . Cerebral palsy was diagnosed in 13 % of hydrocortisone-treated versus 14 % of placebo-treated infants . Fewer hydrocortisone-treated infants had a Mental Development Index < 70 , and more of the hydrocortisone-treated infants showed evidence of awareness of object permanence . Incidence of neurodevelopmental impairment was not different ( 39 % [ hydrocortisone ] vs 44 % [ placebo ] ) . There were no differences in physical growth measures . Chorioamnionitis-exposed infants treated with hydrocortisone were shorter and weighed less than controls but had no evidence of neurodevelopmental impairment . Among infants not exposed to chorioamnionitis , hydrocortisone-treated patients were less likely to have a Mental Development Index of < 70 or to be receiving glucocorticoids at follow-up . CONCLUSIONS . Early , low-dose hydrocortisone treatment was not associated with increased cerebral palsy . Treated infants had indicators of improved developmental outcome . Together with the short-term benefit previously reported , these data support additional studies of hydrocortisone treatment of adrenal insufficiency in extremely premature infants BACKGROUND Early administration of high doses of dexamethasone may reduce the risk of chronic lung disease in premature infants but can cause complications . Whether moderate doses would be as effective but safer is not known . METHODS We r and omly assigned 220 infants with a birth weight of 501 to 1000 g who were treated with mechanical ventilation within 12 hours after birth to receive dexamethasone or placebo with either routine ventilatory support or permissive hypercapnia . The dexamethasone was administered within 24 hours after birth at a dose of 0.15 mg per kilogram of body weight per day for three days , followed by a tapering of the dose over a period of seven days . The primary outcome was death or chronic lung disease at 36 weeks ' postmenstrual age . RESULTS The relative risk of death or chronic lung disease in the dexamethasone-treated infants , as compared with those who received placebo , was 0.9 ( 95 percent confidence interval , 0.8 to 1.1 ) . Since the effect of dexamethasone treatment did not vary according to the ventilatory approach , the two dexamethasone groups and the two placebo groups were combined . The infants in the dexamethasone group were less likely than those in the placebo group to be receiving oxygen supplementation 28 days after birth ( P=0.004 ) or open-label dexamethasone ( P=0.01 ) , were more likely to have hypertension ( P<0.001 ) , and were more likely to be receiving insulin treatment for hyperglycemia ( P=0.02 ) . During the first 14 days , spontaneous gastrointestinal perforation occurred in a larger proportion of infants in the dexamethasone group ( 13 percent , vs. 4 percent in the placebo group ; P=0.02 ) . The dexamethasone-treated infants had a lower weight ( P=0.02 ) and a smaller head circumference ( P=0.04 ) at 36 weeks ' postmenstrual age . CONCLUSIONS In preterm infants , early administration of dexamethasone at a moderate dose has no effect on death or chronic lung disease and is associated with gastrointestinal perforation and decreased growth Importance Dexamethasone to prevent bronchopulmonary dysplasia in very preterm neonates was associated with adverse neurodevelopmental events . Early low-dose hydrocortisone treatment has been reported to improve survival without bronchopulmonary dysplasia but its safety with regard to neurodevelopment remains to be assessed . Objective To assess whether early hydrocortisone therapy in extremely preterm infants is associated with neurodevelopmental impairment at 2 years of age . Design , Setting , and Participants An exploratory secondary analysis of the PREMILOC ( Early Low-Dose Hydrocortisone to Improve Survival without Bronchopulmonary Dysplasia in Extremely Preterm Infants ) r and omized clinical trial conducted between 2008 and 2014 in 21 French neonatal intensive care units . R and omization was stratified by gestational age groups . Neurodevelopmental assessment s were completed from 2010 to 2016 . Interventions After birth , patients were r and omly assigned to receive placebo or hydrocortisone ( 0.5 mg/kg twice per day for 7 days , followed by 0.5 mg/kg per day for 3 days ) . Main Outcomes and Measures The prespecified exploratory secondary outcome of neurodevelopmental impairment was based on a st and ardized neurological examination and the revised Brunet-Lézine scale ( global developmental quotient score and subscores ; mean norm , 100 [ SD , 15 ] ) . The minimal clinical ly important difference on the global developmental quotient was 5 points . Results Of 1072 neonates screened , 523 were assigned to hydrocortisone ( n = 256 ) or placebo ( n = 267 ) and 406 survived to 2 years of age . A total of 379 patients ( 93 % ; 46 % female ) were evaluated ( 194 in the hydrocortisone group and 185 in the placebo group ) at a median corrected age of 22 months ( interquartile range , 21 - 23 months ) . The distribution of patients without neurodevelopmental impairment ( 73 % in the hydrocortisone group vs 70 % in the placebo group ) , with mild neurodevelopmental impairment ( 20 % in the hydrocortisone group vs 18 % in the placebo group ) , or with moderate to severe neurodevelopmental impairment ( 7 % in the hydrocortisone group vs 11 % in the placebo group ) was not statistically significantly different between groups ( P = .33 ) . The mean global developmental quotient score was not statistically significantly different between groups ( 91.7 in the hydrocortisone group vs 91.4 in the placebo group ; between-group difference , 0.3 [ 95 % CI , −2.7 to 3.4 ] ; P = .83 ) . The incidence of cerebral palsy or other major neurological impairments was not significantly different between groups . Conclusions and Relevance In this exploratory analysis of secondary outcomes of a r and omized clinical trial of extremely preterm infants , early low-dose hydrocortisone was not associated with a statistically significant difference in neurodevelopment at 2 years of age . Further r and omized studies are needed to provide definitive assessment of the neurodevelopmental safety of hydrocortisone in extremely preterm infants . Trial Registration clinical trials.gov Identifier : OBJECTIVES To investigate the effect of hydrocortisone treatment on survival without bronchopulmonary dysplasia ( BPD ) and to study whether serum cortisol concentrations predict the response . STUDY DESIGN We performed a r and omized , placebo-controlled trial on infants with gestation < or = 30 weeks , body weight of 501 to 1250 g , and respiratory failure . Hydrocortisone was started before 36 hours of age and given for 10 days at doses from 2.0 to 0.75 mg/kg per day . Shortly before hydrocortisone treatment , basal and stimulated ( ACTH , 0.1 microg/kg ) serum cortisols were measured . RESULTS The study was discontinued early , because of gastrointestinal perforations in the hydrocortisone group ( 4/25 vs 0/26 , P = .05 ) ; 3 of the 4 had received indomethacin/ibuprofen . The incidence of BPD ( 28 % vs placebo 42 % , P = 0.28 ) tended to be lower , and patent ductus arteriosus ( 36 % vs 73 % , P = .01 ) was lower in the hydrocortisone group . The hydrocortisone-treated infants with serum cortisol concentrations above the median had a high risk of gastrointestinal perforation . In infants with cortisol values below the median , hydrocortisone treatment increased survival without BPD . CONCLUSIONS Serum cortisol concentrations measured shortly after birth may identify those very high-risk infants who may benefit from hydrocortisone supplementation Objective . To assess the effectiveness of a “ stress dose ” of hydrocortisone for rescue treatment of refractory hypotension and adrenocortical insufficiency of prematurity in very low birth weight ( VLBW ) infants . We hypothesized that significantly more VLBW infants who were receiving dopamine ≥10 μg/kg per min could wean off vasopressor support 72 hours after treatment with hydrocortisone . Methods . A double-blind , r and omized , controlled study was conducted in a university neonatal center . Forty-eight VLBW infants who had refractory hypotension and required dopamine ≥10 μg/kg per min were r and omly assigned to receive a stress dose of hydrocortisone ( 1 mg/kg every 8 hours for 5 days ; n = 24 ) or an equivalent volume of the placebo solution ( isotonic saline ; n = 24 ) . Results . The baseline clinical characteristics were similar between the groups . Serum cortisol concentrations were very low immediately before r and omization in both groups of infants . Significantly more VLBW infants who were treated with hydrocortisone weaned off vasopressor support 72 hours after starting treatment . The use of volume exp and er , cumulative dose of dopamine , and dobutamine were significantly less in hydrocortisone-treated infants compared with control infants . In addition , the median duration of vasopressor treatment was halved in hydrocortisone-treated patients . Two versus 11 infants in the hydrocortisone and control groups required a second vasopressor for treatment of refractory hypotension . The trend ( linear and quadratic ) of the mean arterial blood pressure was also significantly and consistently higher in hydrocortisone-treated infants . Conclusions . A stress dose of hydrocortisone was effective in treating refractory hypotension in VLBW infants . Although routine and prophylactic use of systemic corticosteroids could not be recommended because of their potential adverse effects , this relatively low dose of hydrocortisone would probably be preferable to high-dose dexamethasone for treatment of ref
Output:
| Conclusion : Early systemic hydrocortisone is a modestly effective therapy for the prevention of BPD in preterm infants , although some safety concerns remain .
No conclusions could be drawn for late hydrocortisone due to the paucity of studies .What is Known:• Preterm infants are at high risk of developing bronchopulmonary dysplasia ( BPD ) and early lung inflammation plays a significant role in its pathogenesis.• Both early and late systemic dexamethasone seems to reduce the incidence of BPD , but its use is associated with serious neurodevelopmental impairment at follow-up .
What is New:• Early systemic hydrocortisone significantly improved survival without BPD at 36 weeks and survival without moderate to severe neurodevelopmental impairment on follow up.• Incidence of gastrointestinal perforation associated with concurrent treatment for PDA was significantly higher , although early systemic hydrocortisone reduced the need for treatment of PDAs |
MS211697 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Our study 's aim was to evaluate the prognostic value of early and intensive lipid-lowering treatment on ventricular premature beat or non-sustained ventricular tachycardia ( NSVT ) after acute coronary syndrome ( STEMI , non-STEMI , and unstable angina pectoris ) . METHODS Some 586 patients with acute coronary syndrome were r and omly divided into two groups : Group A ( with conventional statin therapy , to receive 10 mg/day atorvastatin , n = 289 ) and Group B ( given early and intensive statin therapy , 60 mg immediately and 40 mg/day atorvastatin , n = 297 ) . The frequency of ventricular premature beat and NSVT was recorded via Holter monitoring after hospitalization ( 24 h and 72 h ) . RESULTS Seventy seven ( 11.8 % ) patients had NSVT . When compared to patients with no documented NSVT , patients with NSVT were older and more frequently had myocardial infa rct ion in their history , diabetes mellitus , atrial fibrillation and an ejection fraction < 40 % . Ventricular premature beats decreased significantly in the early and aggressive treatment group ( 24 h , p < 0.01 ; 72 h , p < 0.001 ) . A significant reduction in NSVT was seen in the early and aggressive treatment group ( 24 h , p < 0.01 ; 72 h , p < 0.001 ) . There were no side effects observed in either group . CONCLUSIONS Early and intensive lipid-lowering treatment can clearly decrease ventricular premature beats and NSVT CONTEXT Plasma levels of the inflammatory biomarker C-reactive protein ( CRP ) predict cardiovascular risk , and retrospective studies suggest that 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors ( statins ) may lower CRP in a manner largely independent of low-density lipoprotein cholesterol ( LDL-C ) . However , prospect i ve trial data directly evaluating this anti-inflammatory effect of statins are not available . OBJECTIVE To test the hypothesis that pravastatin has anti-inflammatory effects as evidence d by CRP reduction . DESIGN , SETTING , AND PARTICIPANTS Community-based , prospect i ve , r and omized , double-blind trial including 1702 men and women with no prior history of cardiovascular disease ( primary prevention cohort ) and open-label study including 1182 patients with known cardiovascular disease ( secondary prevention cohort ) who provided at least baseline and 12-week blood sample s. The study was conducted in US office-based practice s from February to December 2000 . INTERVENTIONS Participants in the double-blind primary prevention trial were r and omly assigned to receive 40 mg/d of pravastatin ( n = 865 ) or placebo ( n = 837 ) for 24 weeks . Participants in the secondary prevention cohort received 40 mg/d of open-label pravastatin for 24 weeks . MAIN OUTCOME MEASURE Change in CRP levels from baseline to 24 weeks . RESULTS In the primary prevention trial , compared with placebo , pravastatin reduced median CRP levels by 16.9 % ( P<.001 ) at 24 weeks , reflecting a decrease of 0.02 mg/dL in the pravastatin group while no change in CRP levels was observed in the placebo group . This effect was seen as early as 12 weeks ( median reduction in CRP with pravastatin , 14.7 % ; P<.001 ) and was present among all prespecified subgroups according to sex , age , smoking status , body mass index , baseline lipid levels , presence of diabetes , and use of aspirin or hormone replacement therapy . No significant association was observed between baseline CRP and baseline LDL-C levels , end-of- study CRP and end-of- study LDL-C levels , or change in CRP and change in LDL-C levels over time . In linear regression analyses , the only significant predictors of change in CRP on a log scale were r and omized pravastatin allocation and baseline CRP levels ( P<.001 for both ) . Similar reductions in CRP levels were observed at 12 weeks ( -14.3 % ) and 24 weeks ( -13.1 % ) in the secondary prevention cohort treated with pravastatin ( P<.005 for both ) . CONCLUSIONS In this prospect i ve trial , pravastatin reduced CRP levels at both 12 and 24 weeks in a largely LDL-C-independent manner . These data provide evidence that statins may have anti-inflammatory effects in addition to lipid-lowering effects OBJECTIVES We investigated whether plasma amino-terminal pro-brain natriuretic peptide ( NT-proBNP ) , a marker of cardiac dysfunction and prognosis measured in CORONA ( Controlled Rosuvastatin Multinational Trial in Heart Failure ) , could be used to identify the severity of heart failure at which statins become ineffective . BACKGROUND Statins reduce cardiovascular morbidity and mortality in many patients with ischemic heart disease but not , overall , those with heart failure . There must be a transition point at which treatment with a statin becomes futile . METHODS In CORONA , patients with heart failure , reduced left ventricular ejection fraction , and ischemic heart disease were r and omly assigned to 10 mg/day rosuvastatin or placebo . The primary composite outcome was cardiovascular death , nonfatal myocardial infa rct ion , or stroke . RESULTS Of 5,011 patients enrolled , NT-proBNP was measured in 3,664 ( 73 % ) . The midtertile included values between 103 pmol/l ( 868 pg/ml ) and 277 pmol/l ( 2,348 pg/ml ) . Log NT-proBNP was the strongest predictor ( per log unit ) of every outcome assessed but was strongest for death from worsening heart failure ( hazard ratio [ HR ] : 1.99 ; 95 % confidence interval [ CI ] : 1.71 to 2.30 ) , was weaker for sudden death ( HR : 1.69 ; 95 % CI : 1.52 to 1.88 ) , and was weakest for atherothrombotic events ( HR : 1.24 ; 95 % CI : 1.10 to 1.40 ) . Patients in the lowest tertile of NT-proBNP had the best prognosis and , if assigned to rosuvastatin rather than placebo , had a greater reduction in the primary end point ( HR : 0.65 ; 95 % CI : 0.47 to 0.88 ) than patients in the other tertiles ( heterogeneity test , p = 0.0192 ) . This reflected fewer atherothrombotic events and sudden deaths with rosuvastatin . CONCLUSIONS Patients with heart failure due to ischemic heart disease who have NT-proBNP values < 103 pmol/l ( 868 pg/ml ) may benefit from rosuvastatin BACKGROUND The effectiveness of statins remains to be examined in patients with heart failure ( HF ) with preserved ejection fraction ( EF ) . METHODS AND RESULTS : Among 4,544 consecutive HF patients registered in the Chronic Heart Failure Registry and Analysis in the Tohoku district-2 ( CHART-2 ) between 2006 and 2010 , 3,124 had EF ≥50 % ( HFpEF ; mean age 69 years ; male 65 % ) and 1,420 had EF < 50 % ( HF with reduced EF ( HFrEF ) ; mean age 67 years ; male 75 % ) . The median follow-up was 3.4 years . The 3-year mortality in HFpEF patients was lower in patients receiving statins [ 8.7 % vs. 14.5 % , adjusted hazard ratio ( HR ) 0.74 ; 95 % confidence interval ( CI ) , 0.58 - 0.94 ; P<0.001 ] , which was confirmed in the propensity score-matched cohort ( HR , 0.72 ; 95 % CI , 0.49 - 0.99 ; P=0.044 ) . The inverse probability of treatment weighted further confirmed that statin use was associated with reduced incidence of all-cause death ( HR , 0.71 ; 95 % CI , 0.62 - 0.82 , P<0.001 ) and noncardiovascular death ( HR , 0.53 ; 95 % CI , 0.43 - 0.66 , P<0.001 ) , specifically reduction of sudden death ( HR , 0.59 ; 95 % CI , 0.36 - 0.98 , P=0.041 ) and infection death ( HR , 0.53 ; 95 % CI , 0.35 - 0.77 , P=0.001 ) in HFpEF . In the HFrEF cohort , statin use was not associated with mortality ( HR , 0.87 ; 95 % CI , 0.73 - 1.04 , P=0.12 ) , suggesting a lack of statin benefit in HFrEF patients . CONCLUSIONS These results suggest that statin use is associated with improved mortality rates in HFpEF patients , mainly attributable to reductions in sudden death and noncardiovascular death BACKGROUND Clinical data on the mortality and morbidity of unselected Japanese patients with heart failure ( HF ) are limited . In this study , we aim ed to determine the clinical characteristics , long-term outcomes , and prognostic factors of Japanese HF patients with preserved or reduced left ventricular ejection fraction ( LVEF ) . METHODS AND RESULTS We used a single hospital-based cohort from the Shinken Data base 2004 - 2011 that comprised all new patients ( n=17,517 ) visiting the Cardiovascular Institute Hospital . A total of 1,525 patients diagnosed with symptomatic HF at the initial visit were included in the analysis . Of these , 1121 patients ( 74 % ) exhibited a preserved LVEF ( > 50 % ) and 404 patients ( 26 % ) had a reduced LVEF ( ≤ 50 % ) . HF patients with preserved LVEF ( HFpEF ) were older and more often female than patients with reduced LVEF ( HFrEF ) . Kaplan-Meier curves and log-rank test results showed that HFpEF patients had a better prognosis than HFrEF patients . However , there were no significant differences in clinical outcomes between HFpEF and HFrEF patients when the analysis was limited to in patients . Cox regression analysis showed that HFpEF patients had a significantly lower risk of all-cause death ( p=0.027 ; hazard ratio , 0.547 , 95 % confidence interval , 0.321 - 0.933 ) . Multivariate analyses performed separately showed that the independent predictors of all-cause death in HFrEF were advanced age , lower body mass index , diabetes mellitus , and the absence of statin treatment , whereas those for HFpEF were advanced age , absence of dyslipidemia , anemia , and left ventricular hypertrophy . CONCLUSIONS This prospect i ve cohort study identified the clinical characteristics , long-term outcomes , and prognostic factors of Japanese HF patients with reduced and preserved ejection fractions in a real-world clinical setting We prospect ively followed 202 patients with ischemic heart failure who underwent percutaneous coronary intervention ( PCI ) for acute myocardial infa rct ion ( left ventricular [ LV ] ejection fraction < 40 % ) . Patients were divided into 2 groups : groups I ( simvastatin group , n = 106 , aged 60.8 + /- 10.3 years , men 71.7 % ) and II ( non-simvastatin group , n = 96 , aged 60.9 + /- 10.4 years , men 78.1 % ) . During 1-year clinical follow-up , simvastatin therapy was associated with a significant reduction in mortality ( 1.9 % vs 7.5 % , p = 0.048 ) , restenosis rate ( 25.7 % vs 43.1 % , p = 0.033 ) , and repeat PCI rate ( 25.7 % vs 43.1 % , p = 0.033 ) , and with significant improvement in LV ejection fraction ( 31 % to 42 % vs 32 % to 39 % , p = 0.042 ) . The event-free survival rate was higher in group I than in group II ( 79.8 % vs 57.0 % , p = 0.001 ) . In conclusion , simvastatin therapy improves LV systolic function and decreases mortality , restenosis , and repeat PCI rate in patients with ischemic heart failure who underwent PCI for acute myocardial infa rct ion BACKGROUND The effects of statins in patients with heart failure with preserved ejection fraction ( HFpEF ) remain unclear . This study aim ed to assess whether statin therapy is associated with a decreased risk of mortality in patients with HFpEF . METHODS We used data from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist ( TOPCAT ) trial . The primary outcome was all-cause mortality . We analyzed hazard ratios ( HRs
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| Significant effects on all clinical outcomes were also found in cohort studies ’ analyses ; the effect was also larger and significant for lipophilic than hydrophilic statins .
Conclusions In conclusion , statins may have a beneficial effect on CV outcomes irrespective of HF etiology and LVEF level .
Lipophilic statins seem to be much more favorable for patients with heart failure |
MS211698 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background Studies have shown that there is a high prevalence of depression in cancer patients . Women with breast cancer may have an even higher risk of depression particularly in a postmenopausal or estrogen deficiency state . A small number of r and omized controlled trials have examined the efficacy of antidepressants compared to that of a placebo in cancer patients , but some results have been difficult to interpret due to a heterogeneous patient group . In the current investigation , we screened newly diagnosed early stage breast cancer patients for depressive symptoms prior to the initiation of adjuvant therapy and investigated whether the oral antidepressant fluoxetine affected depressive symptoms , completion of adjuvant treatment , and quality of life . Methods Patients with newly diagnosed early stage breast cancer were screened for depressive symptoms prior to the initiation of adjuvant therapy . Patients with depressive symptoms were r and omized to a daily oral fluoxetine or a placebo . Patients were then followed for 6 months and evaluated for quality of life , completion of adjuvant treatment , and depressive symptoms . Results A high percentage of patients with newly diagnosed early stage breast cancer were found to have depressive symptoms prior to the initiation of adjuvant therapy . The use of fluoxetine for 6 months result ed in an improvement in quality of life , a higher completion of adjuvant treatment ( chemotherapy , hormonal therapy , chemotherapy plus hormonal therapy ) , and a reduction in depressive symptoms compared to patients who received placebo . Conclusions An antidepressant should be considered for early stage breast cancer patients with depressive symptoms who are receiving adjuvant treatment Little has been done to study the effectiveness of antidepressants in controlling anxiety/depression in a population of cancer patients . A double‐blind placebo‐controlled study was therefore design ed to assess the effectiveness of 20 mg fluoxetine . Of 115 cancer patients who fulfilled entry criteria for levels of distress , 45 patients were r and omized to a fluoxetine treatment group ( FA ) and 46 patients to a placebo group ( PA ) after a 1‐week placebo period design ed to exclude placebo responders . The Montgomery and Asberg Depression Scale ( MADRS ) , the Hamilton Anxiety Scale ( HAS ) , the Hospital Anxiety and Depression Scale ( HADS ) , the Revised Symptom Checklist ( SCL90‐R ) and the Spitzer Quality of Life Index ( SQOLI ) were used to assess the efficacy of fluoxetine . The response rate , defined by a HADS score lower than 8 after 5 weeks of treatment , was not significantly higher in the FA group ( 11 % ) compared to the PA group ( 7 % ) . Compared to the PA group , patients in the FA group showed a significantly greater decrease in SCL90‐R mean total score after 5 weeks , but not a greater decrease in HADS mean score . No difference between the two groups was found in observer‐reported assessment s ( MADRS , HAS and SQOLI ) . Significantly more drop‐outs were observed in the FA group ( n=15 ) than in the PA group ( n=7 ) , although the frequencies of side‐effects were not significantly different Summary Background . Fatigue can significantly interfere with a cancer patient ’s ability to fulfill daily responsibilities and enjoy life . It commonly co-exists with depression in patients undergoing chemotherapy , suggesting that administration of an antidepressant that alleviates symptoms of depression could also reduce fatigue . Methods . We report on a double-blind clinical trial of 94 female breast cancer patients receiving at least four cycles of chemotherapy r and omly assigned to receive either 20 mg of the selective serotonin re-uptake inhibitor ( SSRI ) paroxetine ( Paxil ® , SmithKline Beecham Pharmaceuticals ) or an identical-appearing placebo . Patients began their study medication seven days following their first on- study treatment and continued until seven days following their fourth on- study treatment . Seven days after each treatment , participants completed question naires measuring fatigue ( Multidimensional Assessment of Fatigue , Profile of Mood States-Fatigue/Inertia subscale and Fatigue Symptom Checklist ) and depression ( Profile of Mood States-Depression subscale [ POMS-DD ] and Center for Epidemiologic Studies -Depression [ CES-D ] ) . Results . Repeated- measures ANOVAs , after controlling for baseline measures , showed that paroxetine was more effective than placebo in reducing depression during chemotherapy as measured by the CES-D ( p=0.006 ) and the POMS-DD ( p=0.07 ) but not in reducing fatigue ( all measures , ps > 0.27 ) . Conclusions . Although depression was significantly reduced in the 44 patients receiving paroxetine compared to the 50 patients receiving placebo , indicating that a biologically active dose was used , no significant differences between groups on any of the measures of fatigued were observed . Results suggest that modulation of serotonin may not be a primary mechanism of fatigue related to cancer treatment Goals of the workThis study aim ed to compare the effectiveness of mirtazapine and imipramine on not only the distressing symptoms of cancer patients such as pain , nausea , vomiting , appetite loss , and sleep disturbances but also depressive and anxiety symptoms . Material s and methods Fifty-three patients with cancer who were diagnosed with major depressive disorder , anxiety disorder , or adjustment disorder were included . Twenty patients on mirtazapine , 13 patients on imipramine , and 20 patients in the control group without medication were interviewed during three visits ( baseline , third week , and sixth week ) . Pain , nausea , vomiting , appetite loss , and sleep disturbances were evaluated with self- assessment single-symptom scales during each visit . The patients were also asked to complete the Hospital Anxiety Depression Scale ( HADS ) during each visit . Main results There were no significant differences among the three visits in the mirtazapine , imipramine , or control groups in terms of pain , nausea , vomiting , or appetite loss . For the initial , middle , and late insomnia , only the mirtazapine group showed improvements ( p = 0.001 , p = 0.001 , p = 0.003 ) . There were also significant differences in the mean total ( p = 0.03 ) , anxiety ( p = 0.003 ) , and depression ( p = 0.025 ) scores of HADS among the three visits for patients taking mirtazapine . There were no significant differences for HADS scores from the baseline to the end point for patients taking imipramine or control group patients . Conclusion Our findings suggest that mirtazapine is effective for resolving insomnia as well as anxiety and depressive symptoms in cancer patients . However , more systematic research , such as placebo-controlled studies , is needed Depression is a major complication of cancer . The efficacy and safety of mianserin were evaluated in a r and omized placebo‐controlled trial of 73 depressed women with cancer . According to RDC diagnosis , all patients showed situational major depression . Both groups were well matched for cancer localization , clinical stages , Karnofsky scores , duration of depression , baseline values on the Hamilton Depression Rating Scale ( HDRS ) , Zung Self‐Rating Depression Scale ( ZSRDS ) , and Clinical Global Impression of Illness Severity ( CGI‐S ) , and for type of depression , whether dominantly depressive or depressive‐anxious . Between days 7–21 , there were significantly fewer dropouts with mianserin ( 7 ) than with placebo ( 15 ) . When compared with placebo , there were significant improvements for mianserin for HDRS on days 7 , 21 and 28 , for ZSRDS on days 7 and 28 , and for CGI‐S on days 7 , 14 , 21 and 28 . According to Clinical Global Impression of Illness Improvement ( CGI‐I ) there were significantly more responders with mianserin ( 28 ) than with placebo ( 18 ) . The efficacy index for mianserin was significantly greater than for placebo on days 21 and 28 . At the end of the trial the scores for HDRS sleep disturbance factor and HDRS anxiety‐somatization factor were significantly reduced for mianserin than for placebo . There were no significant differences in side‐effects between treatment groups . It is concluded that mianserin is superior to placebo in reducing the severity and duration of depression which is present especially in patients with advanced cancer . The fact that side‐effects were not a problem with mianserin and that mianserin treatment was safe when used in association with other anticancer drugs suggests that mianserin can be prescribed routinely for alleviating depression in cancer patients OBJECTIVE The efficacy and tolerability of paroxetine in the treatment of depressive disorders is well known , however , its efficacy and safety for the treatment of depression in patients with cancer has been poorly studied . Therefore this study was aim ed at evaluating the efficacy and tolerability of paroxetine in the treatment of depressed patients with haematological malignancy ( HM ) . METHOD Fifty-two patients with major depressive disorder ( MDD ) based on DSM-IV criteria along with comorbid HM were allotted to an 8 week trial with a flexible-dose regime of paroxetine in combination with their chemotherapy or supportive pharmacotherapy . The treatment response was assessed at baseline , week 2 , week 4 and week 8 with the 17-item Hamilton rating scale for depression ( HAM-D17 ) , the Montgomery Asberg depression rating scale ( MADRS ) and the clinical global impression-severity ( CGI-S ) . Side effects were collected with reported adverse events and laboratory tests throughout the study period . RESULTS 44.2 % of 52 patients completed the 8 week trial . Scores on the HAM-D17 , MADRS and CGI-s ( last observation carried forward , LOCF ) at baseline were significantly reduced with a mean reduction of 30.5 % , 32.8 % and 39.1 % , respectively , after 8 weeks treatment with paroxetine . CONCLUSION In this preliminary study , paroxetine was found to be effective and moderately tolerated in the treatment of depressed patients with HM , and the present study calls for a controlled study in this field to extend and form a framework on the psychopharmacological data in this field This preliminary study investigated whether bupropion sustained release ( SR ) improved symptomatic fatigue , depression and quality of life in cancer patients and caregiver quality of life . The sample consisted of a prospect i ve open case series of 21 cancer patients , with fatigue and with or without depression at moderate to severe levels , referred for psychiatric assessment from a tertiary care cancer centre . Both patient symptom ratings and caregiver ratings were measured before and after 4 weeks of treatment with the maximally tolerated dose of bupropion in the range of 100 - 300 mg per day . At trial completion , significant improvement was found for symptoms of fatigue and depression . Subjects were divided into two groups : depressed and non-depressed ( based on a cut-off score of 17 on the Hamilton Depression Rating Scale ) . Both groups reported improvement for fatigue and depressive symptoms . Depressed subjects and their caregivers did not experience any change in quality of life , while the non-depressed subjects and their caregivers reported improvements . Results from this small group of patients suggest that bupropion may have potential as an effective pharmaceutical agent for treating cancer-related fatigue . A r and omized , placebo-controlled trial with this medication is indicated The purpose s of the study are to evaluate the efficacy and safety of mirtazapine 30 mg/daily for 12 weeks to reduce hot flushes ( HF ) in women with previous breast cancer and to assess the influence of the same treatment on sleep quality and other menopausal symptoms . A prospect i ve pilot trial was conducted in 40 breast cancer patients with at least seven HF per day . A HF diary was completed daily ; sleep quality and other menopausal symptoms were assessed with the Pittsburgh Sleep Quality Index ( PSQI ) , the Menopause Rating Scale ( MRS ) and the SF-36 Health Survey . Treatment was never started by 13 out of 40 patients ( 32.5 % ) and was interrupted by 7 out of 27 patients ( 25 % ) due to of the occurrence of side effects ( mostly somnolence ) . In the remaining 20 patients who completed the three months treatment period , there was a 55.6 % ( p < 0.05 ) reduction in HF frequency and 61.9 % ( p < 0.05 ) reduction in HF score as compared to baseline . A significant reduction in the MRS score ( 32.8 % ; p < 0.05 ) was observed . Mirtazapine appears to be effective in reducing HF in breast cancer survivors . The more frequent side effect was somnolence . A sizeable compiliance problem has been observed due to the reluctance to take antidepressant drugs and to side effects We performed an open-label single-institution phase II trial of mirtazapine ( 15 - 30 mg by mouth [ po ] every day [ qd ] ) , a tetracyclic antidepressant that may lead to weight gain , for 8 weeks in nondepressed patients with cancer-related cachexia/anorexia ( CRCA ) . The primary end point was the proportion of patients who gained ≥1 kg at week 4 . Secondary end points were quality of life and appetite . From June 2006 to July 2007 , 17 of 58 eligible patients were enrolled . On intention-to-treat analysis at week 4 , 4 of 17 patients ( 24 % ) gained 1 kg or more , 1 patient maintained weight ( gain of 400 g ) and 2 patients lost weight ( 800 g and 1.2 kg ) ; 24 % and 6 % improved appetite and health-related quality of life ( HQOL ) , respectively .
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| Conversely , there was no advantage with amitriptyline or desipramine .
Compared to placebo , the odds of dropping out due to side effect were higher with fluoxetine and paroxetine and lower with mianserin .
CONCLUSIONS Paroxetine , fluoxetine and mianserin improve cancer-related depression but may vary in efficacy and tolerability . |
MS211699 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: We examined the therapeutic effects of albendazole compared to metronidazole in 120 patients with giardiasis in Hamdan . Patients were r and omized to receive albendazole ( 400 mg , once daily for 5 days ) or metronidazole ( 250 mg , 3 times a day for 5 days ) . Demographic data of the patients , results of stool examination for Giardia trophozoites before and after treatment , and drug side-effects were recorded . After treatment 6 ( 10.0 % ) of the albendazole group had trophozoites compared with 14 ( 23.3 % ) of metronidazole group ( P < 0.05 ) . Patients in the albendazole group had fewer side-effects while 43.3 % of the metronidazole group experienced a metallic taste and 35.0 % experienced loss of appetite . Albendazole is an easy , safe and effective treatment for giardiasis An open , r and omized study was carried out with 100 children to compare the efficacy and security of albendazole and metronidazole to eradicate Giardia lamblia . We included 100 patients in primary school age with giardiasis confirmed by parasitoscopic test who had not received treatment during the 2 previous months . A complete clinical study was performed . By using an aleatory code , the children were distributed in 2 groups : A and B. The clinical data was corroborated and the following tests were made : cell blood count , blood chemistry , direct and concentrated coproparasitoscopic study . Both groups were given an antiparasite treatment consisting of albendazole for group A or metronidazole for group B. Clinical , parasitological and blood controls were conducted before , during and after the treatment . A therapeutic efficacy of 94 % and 98 % for group A and B , respectively , was found . We concluded that albendazole and metronidazole are equally effective in a 5 days treatment period , but some undesirable effects may occur with metronidazole AIM To investigate the efficacy and tolerability of albendazole and metranidazole treatment in giardiasis . METHODS The open comparative r and omized trial was carried out prospect ively from December 1999 to July 2001 in Duzce City of Turkey . The diagnosis was based on the presence of signs and symptoms compatible with giardiasis including a positive stool examination of giardia cysts or trophozoite . Metranidazole group consisted of 29 patients and was given metranidazole 500 mg , three times a day for 5 d and albendazole group was consisted of 28 patients and was given albendazole 400 mg/d for 5 d. RESULTS There were no significant differences in demographical and therapeutical effects and patient 's compliance between both groups . But side effects were seen more in metranidazole group than in albendazole group . CONCLUSION Albendazole is as effective as metranidazole in adults ' giardiasis . Albendazole has less side effect potentials than metranidazole in the treatment of giardiasis Therapy with metronidazole is the recommended option in giardiasis . However , some clinical trial reports suggest the appearance of drug resistance to explain therapeutic failure . Several investigations have been carried out on the effect of probiotic microorganisms for preventing or treating gastrointestinal diseases , but little is known about their efficacy against protozoal infections . The principal objective of our study was to evaluate the efficacy of Saccharomyces boulardii against Giardia lamblia infections . A double-blind , placebo-controlled study was carried out on adult patients with giardiasis . Group 1 ( 30 patients ) included metronidazole 750 mg 3 times daily along with S. boulardii capsules ( 250 mg b.i.d . orally ) for 10 d while group 2 ( 35 patients ) was treated with metronidazole 750 mg 3 times daily and with empty capsules as placebo for 10 d. Patients were re-examined at 2 and 4 weeks after treatment , and stool examinations were performed . At week 2 , G. lamblia cysts were detected in 6 cases ( 17.1 % ) of group 2 and none in group 1 . At the end of the fourth week , presence of the cysts continued in the same 6 cases in group 2 ( control group ) . These findings indicated that S. boulardii may be effective in treating giardiasis when combined with metronidazole therapy Giardia lamblia is a flagellate protozoan that produces symptoms by infecting the small bowel and biliary tract in the trophozoite form . Diagnosis is currently established by microscopic visualization of the organism in appropriate intestinal contents ( stool , small-bowel contents , or biopsy specimen ) . Adult patients with diarrhea and one or more enteric symptoms may be enrolled in clinical trials of new drugs for the treatment of giardial disease . A r and omized , double-blind , active-concurrent-control design is recommended . Post hoc stratification by age , immune status , chronicity of disease , and ease of establishing diagnosis ( organism load ) may be performed . Microbiological assessment 48 hours to 7 days after the completion of therapy is paramount for determining final outcome Fifty-five patients , 51 males and 4 females heavily infected with Giardia lamblia were treated with a single 2 g dose of tinidazole ( four tablets ) ; 53 were cured . Of 20 other infected patients kept under the same conditions and given four placebo tablets , 18 continued to pass cysts or trophozoites in the stools during the whole 3- to 4-wk follow-up period in hospital . There were no side effects attributed to the drug The efficacy of single-dose ornidazole versus seven days metronidazole in the treatment of giardiasis was tested in a r and omized study of 75 Kibbutzim children in Israel . All the children treated were clinical ly cured , and the parasites disappeared from stool examinations after the first follow-up . By the end of the study ( 21 days after the beginning of treatment ) , all the patients remained free of symptoms , but cysts ofGiardia lamblia were found in the stools of three children from the ornidazole group ( p=0.24 ) . The possibility of treatingGiardia lamblia with ornidazole in a single dose , with results similar to those obtained with a seven-day course of metronidazole , makes this drug a good alternative in the treatment ofGiardia lamblia in children , especially if compliance is not assured One hundred children were entered into a r and omized study to compare the efficacy and safety of furazolidone and metronidazole when given in liquid suspension for treatment of giardiasis . The study was conducted between May 1985 and February 1986 . Dosages were calculated on the basis of body weight , and treatment lasted 10 days . Clinical diagnosis of giardiasis was confirmed by the presence of Giardia cysts in stools . Children were excluded from the study if stool culture was positive for pathogenic bacteria . Eighteen of the 100 children were withdrawn from the study because of noncompliance with the protocol . Of the 82 remaining patients , 37 received furazolidone and 45 metronidazole . No statistically significant differences in efficacy between treatments were found . With the exception of one case of urticaria , which occurred in a patient who received metronidazole , both drugs were well tolerated . In this study , furazolidone and metronidazole were equally safe and effective in treating children with giardiasis A r and omized controlled trial was carried out to study the efficacy of combined albendazole and praziquantel in the treatment of giardiasis in school-age children . Eighty-four children were r and omly allocated to 3 groups : group 1 ( n = 31 ) albendazole 400 mg combined with praziquantel 20 mg/kg ; group 2 ( n = 26 ) albendazole 800 mg as a single dose ; group 3 ( n = 27 ) tinidazole 50 mg/kg as a single dose . The treatment was considered curative when Giardia was not found in two consecutive stool sample s. The parasitological cure rate was 74.2 % for combined single-dose albendazole-praziquantel , 50 % and 92.6 % in the albendazole and tinidazole groups respectively ( p = 0.0023 ) . There was no statistically significant difference between the cure rates of the combined regimen and tinidazole ( p > 0.05 ) . This combined regimen was considered safe , with only minor side-effects being observed . Of the single-dose regimens , tinidazole still achieves the highest parasitological cure rate for giardiasis . The albendazole-praziquantel combined regimen may be an alternative single-dose therapy for giardiasis in children , especially as this combination will eradicate common intestinal protozoa and co-existing helminths . Whether the dosage of this combination treatment should be adjusted for G. intestinalis remains to be established by further study The therapeutic effects of quinacrine ( Atabrine ) and metronidazole ( Flagyl ) were compared in a 3-year prospect i ve study of 160 infants and children ( 86 boys and 74 girls ranging in age from 4.5 months to 13 years ) with giardiasis . The most common symptom was recurrent abdominal pain . In each study group stool examinations were done 5 days , 1 month , and 6 months after treatment . There were no treatment failures with metronidazole , whereas four of those treated with quinacrine had positive stools 5 days after treatment , indicating possible failure . There were no recurrences at 1 month ; after 6 months , however , Giardia infection was found in 13 % of both treatment groups . These recurrences were seen mainly in children from families with other infected members . Considering the low failure rate , the minimal side effects , and the relatively more tolerable flavor , metronidazole seems to be preferrable in the treatment of giardiasis . A dosage of 15 - 25 mg/kg a day for 5 days is recommended The adverse effects and treatment failures to some of the currently recommended drugs for giardia infection have given rise to the need for alternative antigiardial agents . In an open , r and omized parallel group study , the safety and efficacy of albendazole was compared with that of metronidazole for the treatment of giardiasis in children . Sixty two children aged between 2 - 12 years were r and omized to receive either albendazole suspension 400 mg daily for 5 days or metronidazole suspension 7.5 mg/kg thrice daily for 5 days . The mean days required for cure , as evident by absence of cysts and /or trophozoites in the stool specimen , was 3.7 + 1.4 and 4.5 + 1.1 days , respectively for children on albendazole and metronidazole therapy . Six children on metronidazole therapy developed anorexia 2 to 4 days after the treatment . Albendazole proved as effective as metronidazole in the treatment of giardia infection in children with the added advantage of absence of anorexia The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . The protozoan parasite Giardia lamblia is a major cause of waterborne enteric disease worldwide . Lectins are proteins that bind to carbohydrate ( sugar ) moieties . Potential targets for lectins are found on the surface of most single-celled organisms . Modest concentrations of wheat germ agglutinin ( WGA ) have been shown to inhibit G. lamblia excystation and trophozoite growth in vitro and can reduce cyst passage in mice infected with the closely related protozoan parasite , G. muris . Commercial preparations of wheat germ ( WG ) contain 13 - 53 microg of WGA per gram . We performed a double-masked , placebo-controlled study of dietary supplementation with WG in 63 subjects with giardiasis in Montreal and Lima ( 25 asymptomatic patients passing cysts ; 38 patients with symptoms ) . Asymptomatic subjects received WG ( 2 g , 3 times a day ) or placebo ( cornstarch , 2 g , 3 times a day ) for 10 days , followed by metronidazole ( 250 mg 3 times a day ) for 7 days . Symptomatic subjects received metronidazole ( 250 mg 3 times a day ) plus either WG or placebo for 7 days . Stool specimens were collected every day ( Montreal ) or every other day ( Lima ) for 10 days and on Day 35 for microscopic examination and coproantigen determination . Subjects kept a diary of symptoms for 10 days after recruitment . In asymptomatic subjects , both cyst passage and coproantigen levels were reduced by approximately 50 % in those taking WG compared with the placebo group ( P < 0.01 and P = 0.06 , respectively ) . In symptomatic subjects , cyst passage and coproantigen levels fell precipitously in response to metronidazole therapy , and there were no clinical ly important differences between those receiving supplemental WG or placebo . However , symptoms appear to have resolved more rapidly in the subjects taking WG in addition to metronidazole . The WG supp
Output:
| Albendazole may be of similar effectiveness to metronidazole , may have fewer side effects , and has the advantage of a simplified regimen . |
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