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MS210900 | ***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 effect of a video decision support tool on the preferences for future medical care in older people if they develop advanced dementia , and the stability of those preferences after six weeks . Design R and omised controlled trial conducted between 1 September 2007 and 30 May 2008 . Setting Four primary care clinics ( two geriatric and two adult medicine ) affiliated with three academic medical centres in Boston . Participants Convenience sample of 200 older people ( ≥65 years ) living in the community with previously scheduled appointments at one of the clinics . Mean age was 75 and 58 % were women . Intervention Verbal narrative alone ( n=106 ) or with a video decision support tool ( n=94 ) . Main outcome measures Preferred goal of care : life prolonging care ( cardiopulmonary resuscitation , mechanical ventilation ) , limited care ( admission to hospital , antibiotics , but not cardiopulmonary resuscitation ) , or comfort care ( treatment only to relieve symptoms ) . Preferences after six weeks . The principal category for analysis was the difference in proportions of participants in each group who preferred comfort care . Results Among participants receiving the verbal narrative alone , 68 ( 64 % ) chose comfort care , 20 ( 19 % ) chose limited care , 15 ( 14 % ) chose life prolonging care , and three ( 3 % ) were uncertain . In the video group , 81 ( 86 % ) chose comfort care , eight ( 9 % ) chose limited care , four ( 4 % ) chose life prolonging care , and one ( 1 % ) was uncertain ( χ2=13.0 , df=3 , P=0.003 ) . Among all participants the factors associated with a greater likelihood of opting for comfort care were being a college graduate or higher , good or better health status , greater health literacy , white race , and r and omisation to the video arm . In multivariable analysis , participants in the video group were more likely to prefer comfort care than those in the verbal group ( adjusted odds ratio 3.9 , 95 % confidence interval 1.8 to 8.6 ) . Participants were re-interviewed after six weeks . Among the 94/106 ( 89 % ) participants re-interviewed in the verbal group , 27 ( 29 % ) changed their preferences ( κ=0.35 ) . Among the 84/94 ( 89 % ) participants re-interviewed in the video group , five ( 6 % ) changed their preferences ( κ=0.79 ) ( P<0.001 for difference ) . Conclusion Older people who view a video depiction of a patient with advanced dementia after hearing a verbal description of the condition are more likely to opt for comfort as their goal of care compared with those who solely listen to a verbal description . They also have more stable preferences over time . Trial registration Clinical trials.gov NCT00704886 OBJECTIVE To examine factors associated with family satisfaction with end-of-life care in the Study to Underst and Prognoses and Preferences for Outcomes and Risks of Treatments ( SUPPORT ) . DESIGN A prospect i ve cohort study with patients r and omized to either usual care or an intervention that included clinical nurse specialists to assist in symptom control and facilitation of communication and decision-making . SETTING Five teaching hospitals in the United States . PARTICIPANTS Family members and other surrogate respondents for 767 seriously ill hospitalized adults who died . MEASUREMENTS Eight question naire items regarding satisfaction with the patient 's medical care expressed as two scores , one measuring satisfaction with patient comfort and the other measuring satisfaction with communication and decision-making . RESULTS Sixteen percent of respondents reported dissatisfaction with patient comfort and 30 % reported dissatisfaction with communication and decision-making . Factors found to be significantly associated with satisfaction with communication and decision-making were hospital site , whether death occurred during the index hospitalization ( adjusted odds ratio ( AOR ) 2.2 , 95 % CI , 1.3 - 3.9 ) , and for patients who died following discharge , whether the patient received the SUPPORT intervention ( AOR 2.0 , 1.2 - 3.2 ) . For satisfaction with comfort , male surrogates reported less satisfaction ( 0.6 , 0.4 - 1.0 ) , surrogates who reported patients ' preferences were followed moderately to not at all had less satisfaction ( 0.2 , 0.1 - 0.4 ) , and surrogates who reported the patient 's illness had greater effect on family finances had less satisfaction ( 0.4 , 0.2 - 0.8 ) . CONCLUSIONS Satisfaction scores suggest the need for improvement in end-of-life care , especially in communication and decision making . Further research is needed to underst and how factors affect satisfaction with end-of-life care . An intervention like that used in SUPPORT may help family members The purpose of this study was to describe the life-sustaining treatment preferences of dialysis patients and to compare the acceptability of two generic and a disease-specific advance directive ( AD ) . Of 532 potentially eligible hemodialysis patients , 95 ( 17.9 % ) participated in the study . These patients completed two generic ( the Centre for Bioethics Living Will and the Medical Directive ) and one disease-specific ( the Dialysis Living Will ) AD in a r and omized cross-over trial . Treatment preferences were measured by using the Centre for Bioethics Living Will . Acceptability of the AD was measured by using a 13-item advance directive acceptability question naire ( ADAQ ) for each AD , and the advance directive choice question naire ( ADCQ ) to elicit participants ' preferred AD . Twenty-five percent of the participants wanted to continue dialysis in case of severe stroke , 19 % in severe dementia , and 14 % in permanent coma . Averaged across treatments , proportions of participants wanting treatment in various health states were : current health ( 86 % ) , mild stroke ( 84 % ) , moderate stroke ( 60 % ) , severe stroke ( 21 % ) , mild dementia ( 78 % ) , moderate dementia ( 51 % ) , severe dementia ( 14 % ) , terminal illness ( 41 % ) , and permanent coma ( 10 % ) . Averaged across health states , proportions of participants wanting various types of treatment were : dialysis ( 58 % ) , antibiotics ( 53 % ) , transfusion ( 53 % ) , surgery ( 48 % ) , cardiopulmonary resuscitation ( 48 % ) , respirator ( 47 % ) , and tube feeding ( 41 % ) . Mean ADAQ scores were : Dialysis Living Will , 71 % ; Centre for Bioethics Living Will , 70 % ; and Medical Directive , 60 % ( F = 8.27 , P < 0.001 ( repeat measures analysis of variance ) ; the Dialysis Living Will and Centre for Bioethics Living Will scored significantly higher than the Medical Directive ) . The proportion of participants who said they would choose to complete each AD was : Dialysis Living Will , 28 % ; Centre for Bioethics Living Will , 38 % ; Medical Directive , 31 % ; and unsure , 3 % ( chi 2 = 1.465 , df = 2 , P = 0.48 ) . In conclusion , twenty-five percent or less of hemodialysis patients want to continue dialysis in three specific health states : severe stroke , severe dementia , and permanent coma . Health states and illness severity , far more than treatment descriptions , influence preferences . Dialysis patients should be offered a generic AD , and some generic AD are more acceptable than others . Only a minority of dialysis patients will complete any AD , but the completion of written AD forms is only one element in the process of advance care planning BACKGROUND A large discrepancy exists between the wishes of dying patients and their actual end-of-life care . However , retrospective clinical experience suggests that early advance care planning ( ACP ) can markedly reduce this discrepancy . This article describes a r and omized trial to evaluate the short-term clinical utility of early ACP . We also assessed the feasibility of performing a larger prospect i ve study to document long-term outcomes . METHODS Ambulatory geriatric patients ( N = 61 ) were r and omized to either a control group , which received only a Massachusetts Health Care Proxy form to complete , or an intervention group , in which each patient and health care agent discussed ACP with a trained nurse facilitator . The benefits and burdens of life-sustaining treatments were discussed , and patient goals and preferences for these treatments were documented . RESULTS Two-month follow-up revealed that the intervention achieved higher congruence between agents and patients in their underst and ing of patients ' end-of-life care preferences , with 76 % ( 19/25 ) in complete agreement vs 55 % ( 12/22 ) of the controls ( effect size [ ES ] = -0.43 ) . There was also a greater increase in patient knowledge about ACP in the intervention group ( ES = 0.22 ) . Intervention patients became less willing to undergo life-sustaining treatments for a new serious medical problem ( ES = -0.25 ) , more willing to undergo such treatments for an incurable progressive disease ( ES = 0.24 ) , and less willing to tolerate poor health states ( ES = -0.78 ) . Practical insights were gained about how to conduct a larger study more effectively . CONCLUSION A facilitated discussion about end-of-life care between patients and their health care agents helps define and document the patient 's wishes for both patient and agent OBJECTIVE Little is known about the effectiveness of advance care planning in the United Kingdom , although policy documents recommend that it should be available to all those with life-limiting illness . METHOD An exploratory patient preference r and omized controlled trial of advance care planning discussion s with an independent mediator ( maximum three sessions ) was conducted in London outpatient oncology clinics and a nearby hospice . Seventy-seven patients ( mean age 62 years , 39 male ) with various forms of recurrent progressive cancer participated , and 68 ( 88 % ) completed follow-up at 8 weeks . Patients completed visual analogue scales assessing perceived ability to discuss end-of-life planning with healthcare professionals or family and friends ( primary outcome ) , happiness with the level of communication , and satisfaction with care , as well as a st and ardized measure of anxiety and depression . RESULTS Thirty-eight patients ( 51 % ) showed preference for the intervention . Discussion s with professionals or family and friends about the future increased in the intervention arms , whether r and omized or preference , but happiness with communication was unchanged or worse , and satisfaction with services decreased . Trial participation did not cause significant anxiety or depression and attrition was low . SIGNIFICANCE OF RESULTS A r and omized trial of advance care planning is possible . This study provides new evidence on its acceptability and effectiveness for patients with advanced cancer BACKGROUND Patients with severe COPD or chronic heart failure ( CHF ) are often confronted with decisions concerning life-sustaining treatments . The aim of this prospect i ve , observational study was to assess life-sustaining treatment preferences , advance care planning , and the quality of end-of-life care communication in Dutch out patients with clinical ly stable but severe COPD or CHF . METHODS The following outcomes were assessed in out patients with severe COPD ( n = 105 ) or CHF ( n = 80 ) : life-sustaining treatment preferences ( CPR and mechanical ventilation ; Willingness to Accept Life-sustaining Treatment instrument ) , advance care planning , and quality of end-of-life care communication ( Quality of Communication question naire ) . RESULTS Most patients asserted that in their current health status , they would prefer CPR ( COPD , 70.5 % ; CHF , 62.5 % ) and /or mechanical ventilation ( COPD , 70.5 % ; CHF , 66.3 % ) . Patients ' treatment preferences were influenced by burden of treatment , outcome of treatment , and likelihood of outcome . Advance directives were discussed with the physician specialist by 5.9 % of patients with COPD and 3.9 % of patients with CHF . Patients rated quality of patient-physician end-of-life care communication as poor . Physicians rarely discussed prognosis , dying , and palliative care . CONCLUSIONS Despite the fact that patients are able to indicate their preferences regarding life-sustaining treatments , based on burden of treatment , outcome of treatment , and likelihood of outcome , these preferences are rarely discussed with their physician specialist . This study shows a need for advance care planning , taking into account the burden of treatment , outcome of treatment , and likelihood of outcome , in patients with severe COPD or CHF . Finally , the quality of patient-physician end-of-life care communication needs to improve BACKGROUND AND PURPOSE Systematic review s and meta-analyses often include an evaluation of the method ological quality of the individual studies that have been included , and are usually conducted by at least 2 individuals . The objective of this study was to assess the method ological quality and reliability of a series of r and omized controlled trials ( RCTs ) of both pharmacological and nonpharmacological interventions by use of the 10-item Physiotherapy Evidence -Based Data base ( PEDro ) Scale . METHODS Two abstract ors independently review ed 81 RCTs assessing a variety of interventions . The Cohen kappa statistic and the intraclass correlation coefficient ( ICC ) were used to assess agreement between abstract ors . RESULTS The average total PEDro scores were 5.94 ( SD=1.43 ) for all studies combined , 6.88 ( SD=1.2 ) for pharmacological studies , and 5.29 ( SD=1.26 ) for nonpharmacological studies . The median score for pharmacological studies was significantly higher than that for nonpharmacological studies ( 7 versus 5 ) . Pair-wise kappa scores ranged from a low of .452 for concealed allocation among drug trials to perfect agreement ( 1.00 ) for r and omization and reporting of results from between-group comparisons . The
Output:
| RESULTS Interventions focusing on advance directives as well as interventions that also included communication about end-of-life care increased the completion of advance directives and the occurrence of end-of-life care discussion s between patients and healthcare professionals .
In addition , interventions that also included communication about ACP , improved concordance between preferences for care and delivered care and may improve other outcomes , such as quality of communication . |
MS210901 | ***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 — Oxygen is commonly administered to patients with ST-elevation – myocardial infa rct ion despite previous studies suggesting a possible increase in myocardial injury as a result of coronary vasoconstriction and heightened oxidative stress . Methods and Results — We conducted a multicenter , prospect i ve , r and omized , controlled trial comparing oxygen ( 8 L/min ) with no supplemental oxygen in patients with ST-elevation – myocardial infa rct ion diagnosed on paramedic 12-lead ECG . Of 638 patients r and omized , 441 patients had confirmed ST-elevation – myocardial infa rct ion and underwent primary end-point analysis . The primary end point was myocardial infa rct size as assessed by cardiac enzymes , troponin I , and creatine kinase . Secondary end points included recurrent myocardial infa rct ion , cardiac arrhythmia , and myocardial infa rct size assessed by cardiac magnetic resonance imaging at 6 months . Mean peak troponin was similar in the oxygen and no oxygen groups ( 57.4 versus 48.0 & mgr;g/L ; ratio , 1.20 ; 95 % confidence interval , 0.92–1.56 ; P=0.18 ) . There was a significant increase in mean peak creatine kinase in the oxygen group compared with the no oxygen group ( 1948 versus 1543 U/L ; means ratio , 1.27 ; 95 % confidence interval , 1.04–1.52 ; P=0.01 ) . There was an increase in the rate of recurrent myocardial infa rct ion in the oxygen group compared with the no oxygen group ( 5.5 % versus 0.9 % ; P=0.006 ) and an increase in frequency of cardiac arrhythmia ( 40.4 % versus 31.4 % ; P=0.05 ) . At 6 months , the oxygen group had an increase in myocardial infa rct size on cardiac magnetic resonance ( n=139 ; 20.3 versus 13.1 g ; P=0.04 ) . Conclusion — Supplemental oxygen therapy in patients with ST-elevation – myocardial infa rct ion but without hypoxia may increase early myocardial injury and was associated with larger myocardial infa rct size assessed at 6 months . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01272713 BACKGROUND The clinical effect of routine oxygen therapy in patients with suspected acute myocardial infa rct ion who do not have hypoxemia at baseline is uncertain . METHODS In this registry‐based r and omized clinical trial , we used nationwide Swedish registries for patient enrollment and data collection . Patients with suspected myocardial infa rct ion and an oxygen saturation of 90 % or higher were r and omly assigned to receive either supplemental oxygen ( 6 liters per minute for 6 to 12 hours , delivered through an open face mask ) or ambient air . RESULTS A total of 6629 patients were enrolled . The median duration of oxygen therapy was 11.6 hours , and the median oxygen saturation at the end of the treatment period was 99 % among patients assigned to oxygen and 97 % among patients assigned to ambient air . Hypoxemia developed in 62 patients ( 1.9 % ) in the oxygen group , as compared with 254 patients ( 7.7 % ) in the ambient‐air group . The median of the highest troponin level during hospitalization was 946.5 ng per liter in the oxygen group and 983.0 ng per liter in the ambient‐air group . The primary end point of death from any cause within 1 year after r and omization occurred in 5.0 % of patients ( 166 of 3311 ) assigned to oxygen and in 5.1 % of patients ( 168 of 3318 ) assigned to ambient air ( hazard ratio , 0.97 ; 95 % confidence interval [ CI ] , 0.79 to 1.21 ; P=0.80 ) . Rehospitalization with myocardial infa rct ion within 1 year occurred in 126 patients ( 3.8 % ) assigned to oxygen and in 111 patients ( 3.3 % ) assigned to ambient air ( hazard ratio , 1.13 ; 95 % CI , 0.88 to 1.46 ; P=0.33 ) . The results were consistent across all predefined subgroups . CONCLUSIONS Routine use of supplemental oxygen in patients with suspected myocardial infa rct ion who did not have hypoxemia was not found to reduce 1‐year all‐cause mortality . ( Funded by the Swedish Heart – Lung Foundation and others ; DETO2X‐AMI Clinical Trials.gov number , NCT01787110 . Background Postoperative cognitive dysfunction ( POCD ) is a common complication of cardiac surgery . Studies have identified potentially injurious roles for cardiopulmonary bypass ( CPB ) and subsequent reperfusion injury . Cognitive dysfunction has also been linked to the deleterious effects of hyperoxia following ischemia-reperfusion injuries in several disease states , but there has been surprisingly little study into the role of hyperoxia in reperfusion injury after CPB . The potential for tightly regulated intraoperative normoxia to ameliorate the neurocognitive decline following cardiac surgery has not been investigated in a prospect i ve manner . We hypothesize that the use of a protocol ized management strategy aim ed towards maintenance of an intraoperative normoxic level of oxygen , as opposed to hyperoxia , will reduce the incidence of POCD in older patients undergoing cardiac surgery . Methods / Design One hundred patients aged 65 years and older undergoing non-emergency coronary artery bypass grafting surgery on cardiopulmonary bypass will be enrolled in this prospect i ve , r and omized , controlled trial . Subjects will be r and omized to receive a fraction of inspired oxygen of either 35 % or 100 % while under general anesthesia throughout the intraoperative period . The primary outcome measure will be the incidence of POCD in the acute postoperative phase and up to 6 months . The assessment of neurocognition will be undertaken by trained personnel , blinded to study group , with the telephone Montreal Cognitive Assessment ( t-MoCA ) tool . Secondary outcome measures will include assessment of delirium using the Confusion Assessment Method ( CAM and CAM-ICU ) , as well as time to extubation , days of mechanical ventilation , length of ICU and hospital stay and mortality at 6 months . With the aim of later identifying mechanistic aspects of the effect of oxygen tension , blood , urine , and atrial tissue specimens will be taken at various time points during the perioperative period and later analyzed . Discussion This trial will be one of the first r and omized controlled studies to prospect ively assess the relationship between intraoperative oxygen levels and postoperative neurocognition in cardiac surgery . It addresses a promising biological avenue of intervention in this vulnerable aging population .Trial registration Clinical Trials.gov Identifier : NCT02591589 , registered February 13 , 2015 Although an adverse influence of hyperoxemia during cardiopulmonary bypass is well documented , there is a wide range of oxygen setting s during cardiopulmonary bypass , based mostly on trial and error . The aim of this study was to determine the optimal inspired oxygen fraction during cardiopulmonary bypass . Ninety patients undergoing isolated coronary artery bypass operations were r and omly allocated to one of 3 groups of 30 each . In group 1 , cardiopulmonary bypass was started with an inspired oxygen fraction of 0.40 , increased to 0.60 during rewarming . These setting s were 0.40 and 0.50 in group 2 , and 0.35 and 0.45 in group 3 . Sample s for blood gas analysis were collected at defined time periods during the operation . PaO2 was significantly higher in groups 1 and 2 compared to group 3 . All patients in group 1 and 88 % of patients in group 2 suffered at least one episode of hyperoxemia during cardiopulmonary bypass , compared to 30 % of patients in group 3 . The differences were significant , and we concluded that to avoid hyperoxemia , inspired oxygen fraction should be kept at 0.35 during cardiopulmonary bypass and increased to 0.45 during rewarming Objective : To determine whether higher levels of PaO2 are associated with in-hospital mortality and poor neurological status at hospital discharge in patients treated with mild therapeutic hypothermia after sudden cardiac arrest . Design : Retrospective analysis of a prospect i ve cohort . Patients : A total of 170 consecutive patients treated with therapeutic hypothermia in the cardiovascular care unit of an academic tertiary care hospital . Interventions : None . Measurements and Main Results : Of 170 patients , 77 ( 45.2 % ) survived to hospital discharge . Survivors had a significantly lower maximum PaO2 ( 198 mm Hg ; interquartile range , 152.5–282 ) measured in the first 24 hrs following cardiac arrest compared to nonsurvivors ( 254 mm Hg ; interquartile range , 172–363 ; p = .022 ) . A multivariable analysis including age , time to return of spontaneous circulation , the presence of shock , byst and er cardiopulmonary resuscitation , and initial rhythm revealed that higher levels of PaO2 were significantly associated with increased in-hospital mortality ( odds ratio 1.439 ; 95 % confidence interval 1.028–2.015 ; p = .034 ) and poor neurological status at hospital discharge ( odds ratio 1.485 ; 95 % confidence interval 1.032–2.136 ; p = .033 ) . Conclusions : Higher levels of the maximum measured PaO2 are associated with increased in-hospital mortality and poor neurological status on hospital discharge in patients treated with mild therapeutic hypothermia after sudden cardiac arrest Background The safety of perioperative hyperoxia is currently unclear . Previous studies in patients undergoing coronary artery bypass surgery suggest reduced myocardial damage when avoiding extreme perioperative hyperoxia ( > 400 mmHg ) . In this study we investigated whether an oxygenation strategy from moderate hyperoxia to a near-physiological oxygen tension reduces myocardial damage and improves haemodynamics , organ dysfunction and oxidative stress . Methods This was a single-blind , single-centre , open-label , r and omised controlled trial in patients undergoing elective coronary artery bypass surgery . Fifty patients were r and omised to a partial pressure of oxygen in arterial blood ( PaO2 ) target of 200–220 mmHg during cardiopulmonary bypass and 130–150 mmHg during intensive care unit ( ICU ) admission ( control group ) versus lower targets of 130–150 mmHg during cardiopulmonary bypass and 80–100 mmHg at the ICU ( conservative group ) . Primary outcome was myocardial injury ( CK-MB and Troponin-T ) at ICU admission and 2 , 6 and 12 hours thereafter . Results Weighted PaO2 during cardiopulmonary bypass was 220 mmHg ( interquartile range ( IQR ) 211–233 ) vs. 157 ( 151–162 ) in the control and conservative group , respectively ( P < 0.0001 ) . During ICU admission , weighted PaO2 was 107 mmHg ( 86–141 ) vs. 90 ( 84–98 ) ( P = 0.03 ) , respectively . Area under the curve of CK-MB was median 23.5 μg/L/h ( IQR 18.4–28.1 ) vs. 21.5 ( 15.8–26.6 ) ( P = 0.35 ) and 0.30 μg/L/h ( 0.25–0.44 ) vs. 0.39 ( 0.24–0.43 ) ( P = 0.81 ) for Troponin-T. Cardiac index , systemic vascular resistance index , creatinine , lactate and F2-isoprostane levels were not different between groups . Conclusions Compared to moderate hyperoxia , a near-physiological oxygen strategy does not reduce myocardial damage in patients undergoing coronary artery bypass surgery . Conservative oxygen administration was not associated with increased lactate levels or hypoxic events . Trial registration Netherl and s Trial Registry NTR4375 , registered on 30 January Background Valvular heart surgery ( VHS ) utilizing cardiopulmonary bypass ( CPB ) is inevitably associated with ischemic-reperfusion injury , which is known to depend on oxygen tension during reperfusion . The aim of this study was to evaluate the effect of arterial oxygen tension during reperfusion on myocardial recovery in patients undergoing VHS . Methods Fifty-six patients undergoing isolated VHS were r and omly exposed to an oxygen fraction of 0.7 ( hyperoxic group , n = 28 ) or 0.5 ( normoxic group , n = 28 ) during reperfusion . All patients received an oxygen fraction of 0.7 during CPB . In the normoxic group , the oxygen fraction was lowered to 0.5 from the last warm cardioplegia administration to 1 minute after aortic uncl
Output:
| Conclusions Hyperoxia had minimal impact on organ dysfunction , length of stay , and mortality in adult cardiac surgery .
Conclusions L’hyperoxie a eu des répercussions minimes sur le dysfonctionnement des organes , la durée de séjour et la mortalité au cours de la chirurgie cardiaque de l’adulte . |
MS210902 | ***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: Analysis of prospect i ve follow-up data usually includes a Cox regression model . When a hazard rate ratio , obtained as the exponential of an estimated regression coefficient from the Cox model , is greater than 1.0 , it consistently exceeds relative risk , and is exceeded by the odds ratio . The divergence of these distinct epidemiologic measures increases with the product of three factors : ( 1 ) the length of follow-up , ( 2 ) the average rate of the end point occurence over the follow-up period , and ( 3 ) the magnitude of risk , either above or below 1 . Cornfield 's rare disease assumption is basically the product of the first two of these factors . However , risks in excess of 2.5 have a powerful effect on the divergence of these measures , and this point has received less emphasis . Conversely , and as seen frequently in applications , relative risk , hazard rate ratio , and odds ratio numerically approximate one another with shorter follow-up , rarer end points , and risks closer to 1 . Although the hazard rate ratio is not always distinguished from relative risk , it is commonly close to , and is always between , relative risk and the odds ratio . Consistent and accurate terminology would have us use hazard rate ratio with Cox regression and odds ratio with logistic regression . The term " relative risk " seems to be a default choice , regardless of the model being used . However , when relative risk is the object of the model chosen , as in a Poisson regression approximation of two binomial proportions or an equivalent weighted least squares , then for us , relative risk is the accurate terminology Background : Patients who have had a colorectal adenoma are likely to develop a metachronous adenoma and therefore need to be kept under surveillance . It is essential to avoid unnecessary examinations by tailoring the frequency of follow up examinations to individual risk . Methods : A total of 3134 patients undergoing endoscopic removal of colorectal adenomas were prospect ively recorded on the Erlangen Registry of Colorectal Polyps between 1978 and 1996 . A multivariate analysis of 1159 patients on long term follow up was performed to identify risk factors determining surveillance intervals for patients with metachronous adenomas of advanced pathology — that is , adenomas > 10 mm or with high grade dysplasia or invasive carcinoma . Results : Univariate analysis revealed that sex , parental history of colorectal carcinoma , and characteristics of the initial findings —that is , size , multiplicity , and amount of villous structure — were significant predictors of metachronous adenomas of advanced pathology . On the basis of multivariate analysis , two risk groups were identified : ( 1 ) patients with no parental history of colorectal carcinoma with only small ( ≤10 mm ) tubular adenomas at the initial clearing examination have a very low risk , and we estimated that 10 % will develop advanced metachronous adenomas after 10 years ; ( 2 ) the high risk group contained all other patients , 10 % of whom will show metachronous adenomas of advanced pathology at follow up after only three years . Conclusions : The risk of developing metachronous adenomas with advanced pathology can be stratified for various patient and adenoma characteristics . Surveillance intervals can be scheduled for low risk ( 10 years ) and high risk ( three years ) patients . Risk related follow up thus helps to avoid unnecessary examinations PURPOSE : The value of routine colonoscopy in the prevention or early detection of metachronous carcinoma of the colon and rectum remains unproven . This study attempts to clarify this issue . METHODS : An analysis of a personal series of 460 patients with primary colorectal carcinoma treated by the second author between 1972 and 1990 was review ed . After various exclusions , there remained 231 patients who had been prospect ively followed by colonoscopy with a mean follow-up period of 56 years . RESULTS : In 48 ( 21 percent ) patients , there were synchronous adenomas present at the time of the initial resection for carcinoma and 35 ( 73 percent ) of these patients subsequently developed metachronous adenomas , being recurrent in 22 . Ninety-five ( 52 percent ) of the 183 patients without synchronous adenomas eventually developed metachronous adenomas , so that overall 130 ( 56 percent ) patients developed metachronous adenomas . Four patients developed a metachronous carcinoma that was either Dukes A or B , and all remain well at the time of final follow-up . These metachronous carcinomas were found after a mean interval of seven and three-quarter years . All four patients had synchronous adenomas and all developed metachronous adenomas on multiple occasions before the metachronous carcinoma was detected . Thus , a subset consisting of only 22 patients produced all four metachronous malignancies — a rate of 18 percent . CONCLUSION : It would appear that the presence of synchronous adenomas with the subsequent development of recurring metachronous adenomas is significant and warrants a more intensive follow-up program to ensure the early diagnosis and more likely cure of any metachronous carcinoma BACKGROUND & AIMS Limited data exist regarding the actual risk of developing advanced adenomas and cancer after polypectomy or the factors that determine risk . METHODS We pooled individual data from 8 prospect i ve studies comprising 9167 men and women aged 22 to 80 with previously resected colorectal adenomas to quantify their risk of developing subsequent advanced adenoma or cancer as well as identify factors associated with the development of advanced colorectal neoplasms during surveillance . RESULTS During a median follow-up period of 47.2 months , advanced colorectal neoplasia was diagnosed in 1082 ( 11.8 % ) of the patients , 58 of whom ( 0.6 % ) had invasive cancer . Risk of a metachronous advanced adenoma was higher among patients with 5 or more baseline adenomas ( 24.1 % ; st and ard error , 2.2 ) and those with an adenoma 20 mm in size or greater ( 19.3 % ; st and ard error , 1.5 ) . Risk factor patterns were similar for advanced adenomas and invasive cancer . In multivariate analyses , older age ( P < .0001 for trend ) and male sex ( odds ratio [ OR ] , 1.40 ; 95 % confidence interval [ CI ] , 1.19 - 1.65 ) were associated significantly with an increased risk for metachronous advanced neoplasia , as were the number and size of prior adenomas ( P < .0001 for trend ) , the presence of villous features ( OR , 1.28 ; 95 % CI , 1.07 - 1.52 ) , and proximal location ( OR , 1.68 ; 95 % CI , 1.43 - 1.98 ) . High- grade dysplasia was not associated independently with metachronous advanced neoplasia after adjustment for other adenoma characteristics . CONCLUSIONS Occurrence of advanced colorectal neoplasia is common after polypectomy . Factors that are associated most strongly with risk of advanced neoplasia are patient age and the number and size of prior adenomas Acquired or inherited mutations in the adenomatous polyposis coli ( APC ) tumor suppressor gene are causally linked to colorectal cancer . Given the significance of APC in colorectal cancer , we investigated the association between common single-nucleotide polymorphisms ( SNP ) in the APC gene and the odds of developing metachronous colorectal adenomas as a surrogate measure of colorectal cancer risk . Coding SNPs at codons 486 , 1678 , 1822 , 1960 , and 2502 were analyzed in a total of 1,399 subjects who participated in two r and omized clinical trials for the prevention of colorectal adenomas . No association was found for any single SNP and the odds of metachronous adenoma . In contrast , a TA haplotype ( codons 486 and 1822 ) was associated with a statistically significant 27 % and 26 % reduction in the odds of any and nonadvanced metachronous adenoma after adjustment for baseline adenoma characteristics [ odds ratio ( OR ) , 0.73 ; 95 % confidence interval ( 95 % CI ) , 0.59 - 0.91 and OR , 0.74 ; 95 % CI , 0.57 - 0.94 ] , respectively . No significant reduction in odds was observed for advanced metachronous lesions . Diplotype analysis revealed a strong gene dose effect with carriers of two alleles containing TT-AA ( codons 486 and 1822 , respectively ) having an 89 % lower odds for advanced metachronous adenomas ( OR , 0.11 ; 95 % CI , 0.01 - 0.80 ) when compared with the common CC-AA diplotype ( codons 486 and 1822 , respectively ) . Our findings support an important role for germ-line allele sequence in the APC gene and individual risk of metachronous adenomatous polyps PURPOSE : The aim of this study was to identify the high-risk groups for metachronous colorectal carcinoma among patients who undergo colorectal cancer surgery . METHODS : Three hundred forty-one patients undergoing colorectal cancer surgery who had undergone surveillance colonoscopy at least twice during a period of more than three years were analyzed . A metachronous colorectal carcinoma was defined as a new colorectal carcinoma detected by surveillance colonoscopy after surgery . RESULTS : Surveillance colonoscopy was performed 4.6 times per patient during an average of 6.2 years . Twenty-two metachronous colorectal carcinomas in 19 patients were detected , and 14 ( 64 percent ) of 22 were detected within five years of surgery . The cumulative incidence of developing colorectal carcinomas during a five-year period was 5.3 percent . Seventeen ( 77 percent ) of 22 carcinomas were 10 mm or less in size . Ten ( 71 percent ) of the 14 carcinomas in early stages showed a flat appearance . Univariate analysis showed that extracolonic malignancy , coexistence of adenoma , and synchronous multiple colorectal carcinoma were significant predictive factors for detecting colorectal carcinomas in surveillance colonoscopy and that family history of colorectal carcinoma was a possible predictive factor . Multivariate analysis performed with Cox proportional hazards regression model showed that extracolonic malignancy and the coexistence of adenoma were significant predictive factors . CONCLUSION : We recommend that patients with the above predictive factors receive surveillance colonoscopy meticulously and regularly BACKGROUND : Compared with the general population , patients with a previous colorectal cancer are at higher risk for a second colorectal cancer , but detailed risk analysis by subsite is scarce . OBJECTIVE : Our goal was to investigate the risk of a second cancer in relation to subsite as a basis for planning surveillance strategies , . DESIGN , SETTING , AND PATIENTS : This was a retrospective analysis of a prospect ively design ed , population -based cancer registry ( The Netherl and s Cancer Registry ) . Patients with a stage I , II , or III colorectal cancer diagnosed between 1989 and 2008 were included . MAIN OUTCOME MEASURES : Cumulative incidence , st and ardized incidence ratio , and absolute excess risk for second primary cancers in subsites of the colon and rectum were estimated for follow-up periods of 2 to 5 , 6 to 10 , and more than 10 years after the index cancer in patients older than 50 years and in those aged 50 years or younger . RESULTS : A total of 123,347 patients had a first invasive colorectal cancer diagnosed between 1989 and 2008 . Of these , 1849 patients ( 1.5 % ) had a second colorectal lesion that was found more than 1 year after the initial cancer and diagnosed as a second primary colorectal cancer . In patients older than 50 years , the 20-year cumulative incidence for second cancers was 3.4 % in the proximal colon , 1.2 % in the distal colon , and 1.2 % in the rectum . More than 60 % of second cancers occurred within 5 years after the index cancer . The st and ardized incidence ratio was highest in the proximal-colon ( 1.9 ; 95 % CI , 1.8–2.0 ) , followed by the distal-colon ( 1.0 , 95 % CI , 0.9–1.1 ) , and the rectum ( 0.9 , 95 % CI , 0.8–1.0 ) . The corresponding absolute excess risks per 10 000 person years were 9 in the proximal colon , 0.1 in the distal colon , and 1 in the rectum . After 5 years of follow-up , elevated risk was observed only in the proximal colon . A similar risk pattern was observed in patients younger than 50 years . The absolute excess risk for a second cancer in the proximal colon increased over time . The proportion of stage III and stage IV second cancers increased from 31 % during the first 5 years of follow-up to 38 % after 10 years of follow-up . LIMITATIONS : Limitations of this study included lack of data regarding polypectomy rates and interval of surveillance colonoscopies . CONCLUSIONS : Compared with the general population , individuals with previous colorectal cancer have a higher risk for a second cancer in all subsites of the colon and rectum . Among long-term survivors older than 50 years , risk remains elevated only in the proximal colon . Further studies should be encouraged to develop a suitable surveillance method for aging , high-risk , long-term colorectal cancer survivors
Output:
| Meta‐regression showed duration of follow‐up was not a source of heterogeneity for most associations .
There was no evidence that lifestyle factors were associated with metachronous CRC or polyp risk .
Conclusion : A comprehensive list of risk factors identified for metachronous CRC or polyp may have important clinical implication |
MS210903 | ***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 Aims A pilot r and omized controlled trial ( RCT ) to assess the feasibility and potential efficacy of assertive community treatment ( ACT ) in adults with alcohol dependence . Methods Single blind , individually r and omized , pilot RCT of 12 months of ACT plus treatment as usual ( TAU ) versus TAU alone in adults ( age 18 + years ) with alcohol dependence and a history of previous unsuccessful alcohol treatment attending specialist community alcohol treatment services . ACT aim ed to actively engage participants for 12 months with assertive , regular , minimum weekly contact . ACT was combined with TAU . TAU comprised access to the full range of services provided by the community teams . Primary outcome is mean drinks per drinking day and percent days abstinent at 12 months follow up . Analysis of covariance was conducted using 80 % confidence intervals , appropriate in the context of a pilot trial . Results A total of 94 participants were r and omized , 45 in ACT and 49 in TAU . Follow-up was achieved with 98 and 88 % , respectively at 12 months . Those in ACT had better treatment engagement , and were more often seen in their homes or local community than TAU participants . At 12 months the ACT group had more problems related to drinking and lower quality of life than TAU but no differences in drinking measures . The ACT group had a higher percentage of days abstinent but lower quality of life at 6 months . The ACT group had less unplanned healthcare use than TAU . Conclusions An trial of ACT was feasible to implement in an alcohol dependent treatment population . Trial registration IS RCT BACKGROUND People with mental illness and substance use disorder are over-represented in prisons . Injury-related mortality is elevated in people released from prison , and both mental illness and substance use disorder are risk factors for injury . Effective care coordination during the transition between criminal justice and community service providers improves health outcomes for people released from prison . However , the health outcomes and support needs of people with dual diagnosis ( co-occurring mental illness and substance use disorder ) released from prison are poorly understood . Here we aim to examine the association between dual diagnosis and non-fatal injury in adults released from prison . METHODS Pre-release interview data collected between Aug 1 , 2008 , and July 31 , 2010 , from a representative sample of sentenced adults ( ≥18 years ) in Queensl and , Australia , were linked , retrospectively and prospect ively , to person-level , state-wide emergency department and hospital records . We identified dual diagnoses from inpatient , emergency department , and prison medical records . We modelled the association between mental health status and all injury result ing in hospital contact by fitting a multivariate Cox regression , adjusting for sociodemographic , health , and criminogenic covariates , and replacing missing covariate data by multiple imputation . FINDINGS In 1307 adults released from prison , there were 2056 person-years of follow-up ( median 495 days , IQR 163 - 958 ) . The crude injury rates were 996 ( 95 % CI 893 - 1112 ) per 1000 person-years for the dual diagnosis group , 538 ( 441 - 657 ) per 1000 person-years for the mental illness only group , 413 ( 354 - 482 ) per 1000 person-years for the substance use disorder only group , and 275 ( 247 - 307 ) per 1000 person-years for the no mental disorder group . After adjusting for model covariates , the dual diagnosis ( adjusted hazard rate ratio 3·27 , 95 % CI 2·30 - 4·64 ; p<0·0001 ) and mental illness only ( 1·87 , 1·19 - 2·95 ; p=0·0071 ) groups were at increased risk of injury after release from prison compared with the group with no mental health disorders . INTERPRETATION People released from prison experience high rates of injury compared with the general population . Among people released from prison , dual diagnosis is associated with an increased risk of injury . Contact with the criminal justice system is a key opportunity to prevent subsequent injury morbidity in people with co-occurring mental health disorders . Engagement with integrated psychiatric and addiction treatment delivered without interruption during the transition from prison into the community might prevent the injury-related disparities experienced by this vulnerable group . The development of targeted injury prevention strategies for people with dual diagnosis released from prison is warranted . FUNDING National Health and Medical Research Council Integrated mental health and substance abuse treatment within an assertive community treatment ( ACT ) approach was compared to that within a st and ard case management approach for 223 patients with dual disorders over three years . ACT patients showed greater improvements on some measures of substance abuse and quality of life , but the groups were equivalent on most measures , including stable community days , hospital days , psychiatric symptoms , and remission of substance use disorder At three community mental health centers ( CMHCs ) in Indiana , 167 clients at risk for rehospitalization were r and omly assigned to experimental groups receiving assertive case management ( ACM ) or to control groups eligible to receive all other aftercare services at the centers . During a six-month follow-up period , experimental clients received an average of one visit a week from the ACM team , usually in the client 's home or in community setting s. Overall , ACM clients were rehospitalized an average of 9.2 days , significantly less than the 30.8 days for controls . In two of the three centers , significant rehospitalization differences were also found between ACM and control groups . No differences were found between groups in quality of life , medication compliance , involvement in CMHC programs , or contacts with the legal system in any of the centers . The most cost-effective center had savings of about + 5,500 for each ACM client We conducted secondary analyses of data from a r and omized trial testing the effectiveness of Assertive Community Treatment ( ACT ) in delivery of integrated dual disorder treatment ( IDDT ) to explore the impact of IDDT delivered through ACT teams compared with st and ard clinical case management for dually-disordered persons with and without antisocial personality disorder ( ASPD ) . This analysis included 36 individuals with ASPD and 88 individuals without ASPD . Participants with ASPD assigned to ACT showed a significantly greater reduction in alcohol use and were less likely to go to jail than those in st and ard clinical case management , whereas participants without ASPD did not differ between the 2 case management approaches . There were no significant differences for other substance use or criminal justice outcomes . This study provides preliminary evidence that persons with co-occurring serious mental illness , substance use disorders , and ASPD may benefit from delivery of IDDT through ACT teams OBJECTIVE : This study analyzed data from a r and omized trial to examine the impact on medication adherence of integrated treatment delivered via assertive community treatment ( ACT ) versus st and ard clinical case management ( SCCM ) . METHOD : Data from the original study included 198 study participants with co-occurring psychotic and substance use disorders who were r and omly assigned to receive integrated treatment via ACT or SCCM and were followed for 3 years . We applied mixed-effects logistic regression to estimate group ( ACT vs. SCCM ) by time effects on a self-report measure of medication adherence . Adherence was dichotomized as 20 % or more missed medication days ( “ poor adherence ” ) versus less than 20 % missed medication days ( “ adequate adherence ” ) . RESULTS : Participants who were assigned to ACT reported significant improvement in medication adherence compared with those assigned to SCCM . CONCLUSIONS : Integrated treatment delivered via ACT may benefit persons with co-occurring psychotic and substance use disorders who are poorly adherent to medications BACKGROUND People with severe mental illness and substance use disorders ( dual disorder ) often have considerable contact with the criminal justice system . AIMS To test the effects of client characteristics on six criminal justice outcomes among homeless ( at intake ) people with mental illness and substance misuse disorders . METHODS The sample was of participants in a r and omized controlled trial comparing st and ard treatment , assertive community treatment ( ACT ) and integrated treatment ( IT ) . Data were analysed using hierarchical logistic regression . RESULTS Half the sample was arrested and a quarter incarcerated during the two-year follow-up period . The regression models explained between 22 % and 35 % of the variance of the following criminal justice measures : ( 1 ) major offences , ( 2 ) minor offences , ( 3 ) substance-use-related offences , ( 4 ) incarcerations , ( 5 ) arrests , and ( 6 ) summons . Prior criminal behaviour was the strongest predictor of all of the dependent variables ; in general , demographic and diagnostic variables were not . Similarly , neither the type nor the amount of mental health treatment received predicted subsequent criminal behaviour . CONCLUSION Elsewhere the authors have shown that ACT and IT had advantages for health and stability of accommodation but these analyses suggest that more specialized interventions are needed to reduce criminal behaviour in dual disorder individuals OBJECTIVE The ACCESS trial examined the 12-month effectiveness of continuous therapeutic assertive community treatment ( ACT ) as part of integrated care compared to st and ard care in a catchment area comparison design in patients with schizophrenia spectrum disorders treated with quetiapine immediate release . METHOD Two catchment areas in Hamburg , Germany , with similar population size and health care structures were assigned to offer 12-month ACT as part of integrated care ( n = 64 ) or st and ard care ( n = 56 ) to 120 patients with first- or multiple-episode schizophrenia spectrum disorders ( Structured Clinical Interview for DSM-IV Axis I Disorders criteria ) ; multiple-episode patients were restricted to those with a history of relapse due to medication nonadherence . The primary outcome was time to service disengagement . Secondary outcomes comprised medication nonadherence , improvements of symptoms , functioning , quality of life , satisfaction with care from patients ' and relatives ' perspectives , and service use data . The study was conducted from April 2005 to December 2008 . RESULTS 17 of 120 patients ( 14.2 % ) disengaged with service , 4 patients ( 6.3 % ) in the ACT and 13 patients ( 23.2 % ) in the st and ard care group . The mean Kaplan-Meier estimated time in service was 50.7 weeks in the ACT group ( 95 % CI , 49.1 - 52.0 ) and 44.1 weeks in the st and ard care group ( 95 % CI , 40.1 - 48.1 ) . This difference was statistically significant ( P = .0035 ) . Mixed models repeated measures indicated larger improvements for ACT compared to st and ard care regarding symptoms ( P < . 01 ) , illness severity ( P < . 001 ) , global functioning ( P < . 05 ) , quality of life ( P < . 05 ) , and client satisfaction as perceived by patients and family ( both P < . 05 ) . Logistic regression analyses revealed that ACT was associated with a higher likelihood of being employed/occupied ( P = .001 ) , of living independently ( P = .007 ) , and of being adherent with medication ( P < . 001 ) and a lower likelihood of persistent substance misuse ( P = .027 ) . CONCLUSIONS Compared to st and ard care , intensive therapeutic ACT as part of integrated care could improve 1-year outcome . Future studies need to address in which setting s these improvements can be sustained . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01081418 CONTEXT Intensive early treatment for first-episode psychosis has been shown to be effective . It is unknown if the positive effects are sustained for 5 years . OBJECTIVE To determine the long-term effects of an intensive early-intervention program ( OPUS ) for first-episode psychotic patients . DESIGN Single-blinded , r and omized , controlled clinical trial of 2 years of an intensive early-intervention program vs st and ard treatment . Follow-up periods were 2 and 5 years . SETTING Copenhagen Hospital Corporation and Psychiatric Hospital , Aarhus , Denmark . Patients A total of 547 patients with a first episode of psychosis . Of these , 369 patients were participating in a 2-year follow-up , and 301 were participating in a 5-year follow-up . A total of 547 patients were followed for 5 years . INTERVENTIONS Two years of an intensive early-intervention program vs st and ard treatment . The intensive early-intervention treatment consisted of assertive community treatment , family involvement , and social skills training . St and ard treatment offered contact with a community mental health center . MAIN OUTCOME MEASURES Psychotic and negative symptoms were recorded . Secondary outcome measures were use of services and social functioning . RESULTS Analysis was based on the principles of intention-to-treat . Assessment was blinded for previous treatment allocation . At the 5-year follow-up , the effect of treatment seen after 2 years ( psychotic dimension odds ratio [ OR ] , -0.32 ; 95 % confidence interval [ CI ] , -0.58 to -0.06 ; P = .02 ; negative dimension OR , -0.45 ; 95 % CI , -0.67 to -0.22 ; P = .001 ) had equalized between the treatment groups . A significantly smaller percentage of patients from the experimental group were living in supported housing ( 4 % vs 10 % , respectively ; OR , 2.3 ; 95 % CI , 1.1 - 4.8 ; P = .02 ) and were hospitalized fewer days ( mean , 149 vs 193 days ; mean difference , 44 days ; 95 % CI , 0.15 - 88.12 ; P = .05 ) during the 5-year period . CON
Output:
| Higher fidelity to the ACT model appears to improve outcomes .
Substance use reduced only in half of the data sets , of which only one showed a significant reduction in the ACT group .
Overall , ACT is a promising approach that may be useful for promoting treatment engagement for patients with SUD .
According to earlier studies on patients with severe mental illness , patients with high inpatient service use benefit most from this assertive approach .
We hypothesize that a similar high need user group among patients with SUD might benefit most from ACT . |
MS210904 | ***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 determine lower genital tract carriage rates of C. trachomatis , N. gonorrhoeae and bacterial vaginosis among women seeking termination of pregnancy . To compare two clinical management strategies for minimising the risks of infective morbidity after induced abortion . DESIGN Prevalence of infections was assessed by screening women undergoing abortion . Clinical management strategies were compared by a r and omised trial . SETTING The gynaecology departments of four hospitals in Scotl and . PARTICIPANTS 1672 women undergoing induced abortion . INTERVENTIONS Women r and omised to prophylaxis received metronidazole 1 g rectally before abortion plus doxycycline 100 mg twice daily for seven days . Women r and omised to screen- and -treat received appropriate antibiotics only if screening proved positive for one or more infection . MAIN OUTCOME MEASURES Prevalences of infections ; morbidity in the eight weeks following abortion as assessed by reported symptoms , general practitioner consultation and prescription rates and hospital re-attendances ; costs to the NHS of alternative managements . RESULTS Prevalence rates : C. trachomatis 5.6 % ; N gonorrhoeae 0.19 % ; bacterial vaginosis 17.5 % . Overall , women allocated to receive prophylaxis had lower rates of measures of short term infective morbidity than those allocated to screen- and -treat . These differences only reached statistical significance for women who were reported negative on screening . The direct costs to the NHS of prophylaxis and screen- and -treat were calculated to be 8.17 and 18.34 per woman , respectively . CONCLUSIONS Prevalences of lower genital tract infections which have been implicated in increased rates of infective morbidity after abortion are similar to those reported elsewhere . Universal antibiotic prophylaxis is at least as effective as a policy of screen- and -treat in minimising the risk of short term infective morbidity and is far more cost efficient OBJECTIVE To describe the epidemiology of incomplete abortion ( spontaneous miscarriage and illegally induced ) in South Africa . DESIGN Multicentre , prospect i ve , descriptive study . SETTING Fifty-six public hospitals in nine provinces ( a stratified , r and om sample of all hospitals treating gynaecological emergencies ) . PATIENTS All women of gestation under 22 weeks who presented with incomplete abortion during the 2-week study period . MAIN OUTCOME MEASURES Incidence of , morbidity associated with and mortality from incomplete abortion . MAIN RESULTS An estimated 44686 ( 95 % CI 35633 - 53709 ) women per year were admitted to South Africa 's public hospitals with incomplete abortion . An estimated 425 ( 95 % CI 78 - 735 ) women die in public hospitals from complications of abortion . Fifteen per cent ( 95 % CI 13 - 18 ) of patients have severe morbidity while a further 19 % ( 95 % CI 16 - 22 ) have moderate morbidity , as assessed by categories design ed for the study which largely reflect infection . There were marked inter-provincial differences and inter-age group differences in trimester of presentation and proportion of patients with appreciable morbidity . CONCLUSIONS Incomplete abortions and , in particular , unsafe abortions are an important cause of mortality and morbidity in South Africa . The methods used in this study underestimate the true incidence for reasons that are discussed . A high priority should be given to the prevention of unsafe abortion This r and omised controlled trial of 357 patients who had had an incomplete abortion compared suction curettage with conventional curettage for evacuation of the uterus . The 179 patients undergoing suction curettage had a significantly lower intra-operative blood loss ( P < 0.0001 ) and a significantly higher mean haemoglobin level at follow-up compared with the 178 patients who had conventional curettage . Suction curettage was a faster procedure and less painful . No difference was found between the two groups with regard to the incidence of post-abortal sepsis , or the re-evacuation rate . No problems were encountered with the use of suction curettage in the presence of uterine sepsis . In an era where blood transfusions should be kept to an absolute minimum , suction curettage will help to save blood in several ways In 1994 , a national hospital-based study was undertaken of cases of incomplete abortion presenting to public hospitals in South Africa . Data were collected for all women admitted to a r and om sample of hospitals with incomplete abortion during a two-week period . The WHO protocol for such studies was used as a basis for developing the methods to describe the epidemiology of incomplete abortion and hospital management of cases . Attempts were made to estimate the proportion of cases that might have been induced . This report focuses on method ological issues arising from the study that have implication s for future research . The findings demonstrate that only a small proportion of the women acknowledged having had an induced abortion and that only a few of those who did showed evidence of interference with pregnancy . Clinical opinion of sepsis and the likelihood of induction were found to be highly unreliable . These findings considerably reduce the usefulness of the WHO- protocol method of estimating the likely origin of incomplete abortions . Results presented in terms of three partially overlapping descriptive categories are judged to better reflect the limitations of the data collected The responses to therapy with either clindamycin alone or penicillin plus chloramphenicol in 77 patients with septic abortions were compared in a r and omized , double-blind study . Although fever index and duration of hospitalization were similar for both groups of patients , significantly more patients in the group that received clindamycin developed major complications ( P less than 0.05 ) . This is believed to result from clindamycin 's lack of activity against aerobic gram-negative bacilli . Aggressive management that included early uterine evacuation and broad-spectrum antibiotics effective against both aerobic and anaerobic bacteria was the key to reduced morbidity and mortality rates in treatment of septic abortion . For patients treated with clindamycin , early uterine evacuation appeared more important than antibiotic therapy ( P less than 0.005 ) . Bacteremia was documented in a total of 29 patients ( 38 % ) . Bacteremia was polymicrobial in eight patients ( 28 % ) and involved anaerobes exclusively in 18 ( 62 % ) , aerobes exclusively in nine ( 31 % ) , and both aerobes and anaerobes in two ( 7 % ) . The organisms most frequently isolated were Bacteroides ( other than Bacteroides fragilis ) , Peptostreptococcus , and Escherichia coli Opinion is divided as to the advisability of routine use of prophylactic antibiotics for curettage abortion . Six studies , including three r and omized clinical trials , suggest that prophylaxis reduces infectious morbidity associated with curettage abortions by about one half . Three other studies , two involving prophylaxis for instillation abortions and one involving a vaginal antiseptic for curettage abortion , support the hypothesis that antimicrobial prophylaxis reduces morbidity . Tetracyclines are commonly used for this purpose . The cost of routine prophylaxis even with an expensive tetracycline would appear to be offset by the savings in direct and indirect costs . Prophylaxis may help prevent both short-term morbidity and potential late sequelae , such as ectopic pregnancy and infertility OBJECTIVE The objective of this report was to review and describe the management of incomplete abortion by public sector hospitals . DESIGN A descriptive study in which data were collected prospect ively from routine hospital records on all women admitted with incomplete abortion to a stratified r and om sample of hospitals between 14 and 28 September 1994 . SETTING Public sector hospitals in South Africa . PATIENTS Women with incomplete abortions . MAIN OUTCOME MEASURES Length of hospital stay , details of medical management , details of surgical management , determinants of the above . MAIN RESULTS Data were collected on 803 patients from the 56 participating hospitals . Of these , 767 ( 95.9 % ) were in hospital for 1 day or more , and 753 ( 95.3 % ) women underwent evacuation of the uterus . Sharp curettage was the method employed in 726 ( 96.9 % ) and general anaesthesia was used for 601 ( 68 % ) of the women requiring uterine evacuation . Antibiotics were prescribed for 396 ( 49.5 % ) and blood transfusions were administered to 125 ( 17 % ) women . Statistical analysis showed length of stay to be longer in small hospitals ( under 500 beds ) and when the medical condition was more severe . Antibiotic usage and blood transfusion were more common with increasing severity and a low haemoglobin level on admission . However , some inappropriate management was identified with regard to both . MAIN CONCLUSIONS It is suggested that uncomplicated incomplete abortion can be more effectively and safely managed using the manual vacuum aspiration technique with sedation/analgesia as an outpatient procedure . Attention should be directed at the introduction of this management routine at all types of hospital and to the ensuring of appropriate management of women with complicated abortion Objective To investigate the incidence of post‐operative infection after first trimester abortion in women treated with a long‐acting cephalosporin ( ceftriaxone ) compared with low risk patients receiving no treatment and with high risk patients receiving our st and ard treatment of ampicillin/pivampicillin and metronidazole complications . Three patients had haemoptysis and two slight epistaxis . Three patients vomited , including the one in whom the procedure was ab and oned . There were 39 visible tumours . In 29 out of the 38 of these that were examined the histological opinion was definitive . Failure to make a positive diagnosis was associated with necrotic tumour tissue , previous radiotherapy , or a difficult biopsy . Where the appearance was of extrinsic compression a positive diagnosis was possible in only two out of 11 cases . In 11 cases examination showed non-malignant disease The efficacy of prophylactic antibiotic therapy in induced first-trimester abortions was investigated in a double-blind study . Of the 493 women in the study , 254 received doses of 2 million IU of penicillin G intramuscularly one-half hour before and 3 hours after the procedure , followed by 350 mg of pivampicillin three times daily for 4 days , and 239 women received corresponding doses of placebo . The incidence of pelvic infectious complications was 5.5 % in the treated group and 10.9 % in the control group ( p = 0.05 ) . The difference could be attributed to a selective prophylactic effect in women who had earlier suffered from pelvic inflammatory disease ( N = 105 ) . The rate of infection in this group was 22.4 % among those receiving placebo and 2.1 % among those receiving antibiotics ( p = 0.006 ) . Prophylactic administration of antibiotics for first-trimester abortions should be used in women who have earlier had pelvic inflammatory disease A prospect i ve double-blind study was performed to evaluate the effect of prophylactic antibiotic treatment before induced abortion . Eight hundred consecutive women admitted for first-trimester abortion , without signs of genital infection or antibiotic use in the last three weeks , were included in the study . Doxycycline 400 mg or placebo was given as a single oral dose ten to 12 hours before vacuum aspiration . Ninety-one women ( 11.8 % ) returned to the hospital with suspected complications . Thirty-two of these women were diagnosed as having pelvic inflammatory disease , eight of whom ( 2.1 % ) had received doxycycline before the abortion and 24 of whom ( 6.2 % ) had received placebo , a statistically significant difference ( P < .01 ) . A history of pelvic inflammatory disease increased the risk of developing it again after an abortion A r and omized prospect i ve double-blind study was conducted to determine the efficacy of prophylactic antibiotics as compared with placebo in 198 women undergoing secondtrimester intraamniotic injection abortions . Patients received either sodium cephalothin or placebo intravenously before the procedure and for up to 8 additional doses . In 11 patients postabortion endometritis developed ; 2 had received the antibiotic and 9 had received a placebo ( P<.05 ) . Prophylactic cephalothin decreases the incidence of endometritis in patients undergoing midtrimester injection abortion . An injection-abortion interval greater than 24 hours appears to identify patients at increased risk for the development of postabortion endometritis Objective To determine whether prophylactic doxycycline at suction curettage for incomplete abortion decreases the rate of postoperative pelvic infection . Methods We r and omized 240 patients to receive intravenous doxycycline or placebo at curettage . Cervical specimens for gonorrhea and chlamydia were obtained preoperatively . Two weeks post-procedure , we evaluated all patients for infectious morbidity and repeated gonorrhea and chlamydia cultures . Statistical analysis used Mann-Whitney U test , McNemar test , or Fisher exact test , as appropriate . Results There were no statistically significant differences in age , parity , gestational age , history of sexually transmitted disease , pelvic inflammatory disease , or multiple sex partners between the doxycycline and placebo groups . Preoperative gonorrhea or chlam
Output:
| No differences were detected in postabortal infection rates with routine prophylaxis or control .
However , compliance with antibiotic treatment was also low .
REVIEW ER 'S CONCLUSIONS There is not enough evidence to evaluate a policy of routine antibiotic prophylaxis to women with incomplete abortion |
MS210905 | ***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 Virtual environments offer a variety of benefits and may be a powerful medium with which to provide nursing education . The objective of this study was to compare the achievement of learning outcomes of undergraduate nursing students when a virtual patient trainer or a traditional lecture was used to teach pediatric respiratory content . Methods This was a r and omized , controlled , posttest design . A virtual pediatric hospital unit was populated with four virtual pediatric patients having different respiratory diseases that were design ed to meet the same learning objectives as a traditional lecture . The study began in Spring 2010 with 93 Senior I , baccalaureate nursing students . Students were r and omized to receive either a traditional lecture or an experience with a virtual patient trainer . Students ’ knowledge acquisition was evaluated using multiple-choice questions , and knowledge application was measured as timeliness of care in two simulated clinical scenarios using high-fidelity mannequins and st and ardized patients . Results Ninety-three students participated in the study , of which 46 were in the experimental group that received content using the virtual patient trainer . After the intervention , students in the experimental group had significantly higher knowledge acquisition ( P = 0.004 ) and better knowledge application ( P = 0.001 ) for each of the two scenarios than students in the control group . Conclusions The purpose of this project was to compare a virtual patient trainer to a traditional lecture for the achievement of learning outcomes for pediatric respiratory content . Although the virtual patient trainer experience produced statistically better outcomes , the differences may not be clinical ly significant . The results suggest that a virtual patient trainer may be an effective substitute for the achievement of learning outcomes that are typically met using a traditional lecture format . Further research is needed to underst and how best to integrate a virtual patient trainer into undergraduate nursing education Objective . To determine whether using 3-dimensional ( 3D ) technology to teach pharmacy students about the molecular basis of the interactions between drugs and their targets is more effective than traditional lecture using 2-dimensional ( 2D ) graphics . Design . Second-year students enrolled in a 4-year masters of pharmacy program in the United Kingdom were r and omly assigned to attend either a 3D or 2D presentation on 3 drug targets , the β-adrenoceptor , the Na+-K+ ATPase , and the nicotinic acetylcholine receptor . Assessment . A test was administered to assess the ability of both groups of students to solve problems that required analysis of molecular interactions in 3D space . The group that participated in the 3D teaching presentation performed significantly better on the test than the group who attended the traditional lecture with 2D graphics . A question naire was also administered to solicit students ’ perceptions about the 3D experience . The majority of students enjoyed the 3D session and agreed that the experience increased their enthusiasm for the course . Conclusions . Viewing a 3D presentation of drug-receptor interactions improved student learning compared to learning from a traditional lecture and 2D graphics Objective : This study examined the independent effect of a patient 's weight on medical students ’ attitudes , beliefs and interpersonal behavior toward the patient , in addition to the clinical recommendations they make for her care . Design : A total of 76 clinical -level medical students were r and omly assigned to interact with a digital , virtual female patient who was visibly either obese or non-obese . Methods : Interactions with the patient took place in an immersive virtual ( virtual reality ) clinical environment that allowed st and ardization of all patient behaviors and characteristics except for weight . Visual contact behavior was automatically recorded during the interaction . Afterward , participants filled out a battery of self-report question naires . Results : Analyses revealed more negative stereotyping , less anticipated patient adherence , worse perceived health , more responsibility attributed for potentially weight-related presenting complaints and less visual contact directed toward the obese version of a virtual patient than the non-obese version of the patient . In contrast , there was no clear evidence of bias in clinical recommendations made for the patient 's care . Conclusion : Biases in attitudes , beliefs and interpersonal behavior have important implication s because they can influence the tone of clinical encounters and rapport in the patient – provider relationship , which can have important downstream consequences . Gaining a clear underst and ing of the nature and source of weight bias in the clinical encounter is an important first step toward the development of strategies to address it Virtual reality ( VR ) simulation provides a means of making experiential learning reproducible and reusable . This study was design ed to determine the efficiency and satisfaction components of usability . Previously , it was found that first year medical students using a VR simulation for medical education demonstrated effectiveness in learning as measured by knowledge structure improvements both with and without a head mounted display ( HMD ) but students using a HMD showed statistically greater improvement in knowledge structures compared to those not using a HMD . However , in this current analysis of other components of usability , there were no overall significance differences in efficiency ( ease of use ) , nor in satisfaction , within this same group of r and omized subjects comparing students using a HMD to those not using a HMD . These types of studies may be important in determining the most appropriate , cost effective VR simulation technology needed to achieve specific learning goals and objectives
Output:
| Several systems such as Second Life , VisCube and Oculus Rift provide the users with an opportunity to don the role of a virtual avatar and enable users to respond to different situations and circumstances in a virtual world .
This provides an opportunity for the users to gain knowledge and experience specific situations that , under normal circumstances , might not always be possible .
VRE offers several advantages , especially in healthcare professional education .
For example , the simulation of a virtual disaster site could help medical trainees experience the intricacies and difficulties faced during a disaster and can help prepare them in a virtual world .
Study ing anatomy structures in a VRE could help trainees underst and and appreciate the structural complexities of certain organs such as the inner ear . |
MS210906 | ***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 Elderly persons with psychiatric disorders are less likely than younger adults to be diagnosed as having a mental disorder and receive needed mental health treatment . Lack of access to care is 1 possible cause of this disparity . OBJECTIVE To determine whether a nurse-based mobile outreach program to seriously mentally ill elderly persons is more effective than usual care in diminishing levels of depression , psychiatric symptoms , and undesirable moves ( eg , nursing home placement , eviction , board and care placement ) . DESIGN Prospect i ve r and omized trial conducted between March 1993 and April 1996 to assess the effectiveness of the Psychogeriatric Assessment and Treatment in City Housing ( PATCH ) program . SETTING Six urban public housing sites for elderly persons in Baltimore , Md. PARTICIPANTS A total of 945 ( 83 % ) of 1195 residents in the 6 sites underwent screening for psychiatric illness . Among those screened , 342 screened positive and 603 screened negative . All screen-positive subjects aged 60 years and older ( n=310 ) and a 10 % r and om sample of screen-negative subjects aged 60 years and older ( n=61 ) were selected for a structured psychiatric interview . Eleven subjects moved or died ; 245 ( 82 % ) of those who screened positive and 53 ( 88 % ) of those who screened negative were evaluated to determine who had a psychiatric disorder . Data were weighted to estimate the prevalence of psychiatric disorders at the 6 sites . INTERVENTION Among the 6 sites , residents in 3 buildings were r and omized to receive the PATCH model intervention , which included educating building staff to be case finders , performing assessment in residents ' apartments , and providing care when indicated ; and residents in the remaining 3 buildings were r and omized to receive usual care ( comparison group ) . MAIN OUTCOME MEASURES Number of undesirable moves and scores on the Montgomery-Asberg Depression Rating Scale ( MADRS ) , a measure of depressive symptoms , and the Brief Psychiatric Rating Scale ( BPRS ) , a measure of psychiatric symptoms and behavioral disorder , in intervention vs comparison sites . RESULTS Based on weighted data , at 26 months of follow-up , psychiatric cases at the intervention sites had significantly lower ( F(1)=31.18 ; P<.001 ) MADRS scores ( 9.1 vs 15.2 ) and significantly lower ( F(1)=17.35 ; P<.001 ) BPRS scores ( 27.4 vs 33.9 ) than those at the nontreatment comparison sites . There was no significant difference between the groups in undesirable moves ( relative risk , 0.97 ; 95 % confidence interval , 0 . 44 - 2.17 ) . CONCLUSIONS These results indicate that the PATCH intervention was more effective than usual care in reducing psychiatric symptoms in persons with psychiatric disorders and those with elevated levels of psychiatric symptoms . JAMA . 2000;283:2802 - CONTEXT Older adults with social isolation , medical comorbidity , and physical impairment are more likely to be depressed but may be less able to seek appropriate care for depression compared with older adults without these characteristics . OBJECTIVE To determine the effectiveness of a home-based program of detecting and managing minor depression or dysthymia among older adults . DESIGN AND SETTING R and omized controlled trial with recruitment through community senior service agencies in metropolitan Seattle , Wash , from January 2000 to May 2003 . PATIENTS One hundred thirty-eight patients aged 60 years or older with minor depression ( 51.4 % ) or dysthymia ( 48.6 % ) . Patients had a mean of 4.6 ( SD , 2.1 ) chronic medical conditions ; 42 % of the sample belonged to a racial/ethnic minority , 72 % lived alone , 58 % had an annual income of less than 10 000 dollars , and 69 % received a form of home assistance . INTERVENTIONS Patients were r and omly assigned to the Program to Encourage Active , Rewarding Lives for Seniors ( PEARLS ) intervention ( n = 72 ) or usual care ( n = 66 ) . The PEARLS intervention consisted of problem-solving treatment , social and physical activation , and potential recommendations to patients ' physicians regarding antidepressant medications . MAIN OUTCOME MEASURES Assessment s of depression and quality of life at 12 months compared with baseline . RESULTS At 12 months , compared with the usual care group , patients receiving the PEARLS intervention were more likely to have at least a 50 % reduction in depressive symptoms ( 43 % vs 15 % ; odds ratio [ OR ] , 5.21 ; 95 % confidence interval [ CI ] , 2.01 - 13.49 ) , to achieve complete remission from depression ( 36 % vs 12 % ; OR , 4.96 ; 95 % CI , 1.79 - 13.72 ) , and to have greater health-related quality -of-life improvements in functional well-being ( P = .001 ) and emotional well-being ( P = .048 ) . CONCLUSIONS The PEARLS program , a community-integrated , home-based treatment for depression , significantly reduced depressive symptoms and improved health status in chronically medically ill older adults with minor depression and dysthymia The effects of a multifaceted secondary prevention intervention in residential homes in the Netherl and s were examined , using a quasi-experimental design . In five experimental residential homes , the caregivers received three training sessions on detecting depression and on supporting depressed residents . Furthermore , an information session was organized for all personnel , a further session was organized for residents and their relatives , and several group interventions were offered . 213 residents participated in the study . 211 residents of five other residential homes , matched on basic variables , served as a comparison group . Effects on depressive symptoms ( geriatric depression scale ) and health related quality of life ( MOS-SF-36 ) were measured at pretest and after the intervention , one year later . Because the drop-out rate was high and drop-outs differed significantly from the remaining population , the scores of drop-outs were imputed . Since we used a quasi-experimental design , we controlled for confounding variables . Regression analyses result ed in significant effects of the intervention on the GDS and on role functioning in the total population . When the analyses were limited to those scoring high on the GDS at pretest , significant effects were found on the GDS , and on four domains of health-related quality of life : psychological distress , role functioning , pain and social functioning . The improvement in GDS scores in GDS cases was significantly larger than in other subjects . Our results suggest that general approaches aim ed at a residential home are capable of influencing depressive symptoms in inhabitants . Possibly , it may not be necessary to wait until depressive symptoms have escalated and inhabitants need extensive treatment Abstract Objective : To investigate the efficacy of intervention by a psychogeriatric team in the treatment of depression in elderly disabled people receiving home care from their local authority . Design : R and omised controlled trial with blind follow up six months after recruitment . Setting : Community of south east London . Subjects : 69 people aged 65 or over who received home care and were depressed according to criteria of the st and ardised automatic geriatric examination for computer assisted taxonomy ( AGECAT ) . 33 were r and omly allocated to an intervention group and 36 to a control group . Intervention : Members of the intervention group received an individual package of care that was formulated by the community psychogeriatric team in their catchment area and implemented by a research er working as a member of that team . The control group received normal general practitioner care . Main outcome measures : Recovery from depression ( AGECAT case at recruitment but non-case at follow up ) . Results : Data were analysed on an intention to treat basis . 19 ( 58 % ) of the intervention group recovered compared with only nine ( 25 % ) of the control group , a difference of 33 % ( 95 % confidence interval 10 % to 55 % ) . This powerful treatment effect persisted after controlling for possible confounders in logistic regression analysis , with members of the intervention group more likely than members of the control group to have recovered at follow up ( odds ratio 9.0 ( 2.0 to 41.5 ) ) . This did not seem to be a simple effect of antidepressant prescription : use of antidepressants at follow up did not have a significant effect ( multiply adjusted odds ratio 0.3 ( 0.0 to 1.9 ) ) . Conclusions : Depression is treatable in elderly people receiving home care . Therapeutic nihilism based on an assumed poor response to treatment in these socially isolated , disabled elderly people in the community is not supported . Key messages This r and omised controlled trial evaluated whether intervention by a psychi- atric team would improve depression in elderly people receiving home care Overall , 58 % of those receiving the intervention had recovered from their depression six months later compared with only 25 % of those receiving unsup- plemented general practitioner care These results should be achievable by other community old age psychiatry services The current comparative inaction on the part of health and social services needs to be Abstract Objective : To evaluate the effectiveness of a population based , multifaceted shared care intervention for late life depression in residential care . Design : R and omised controlled trial , with control and intervention groups studied one after the other and blind follow up after 9.5 months . Setting : Population of residential facility in Sydney living in self care units and hostels . Participants : 220 depressed residents aged ≥65 without severe cognitive impairment . Intervention : The shared care intervention included : ( a ) multidisciplinary consultation and collaboration , ( b ) training of general practitioners and carers in detection and management of depression , and (c)depression related health education and activity programmes for residents . The control group received routine care . Main outcome measure : Geriatric depression scale . Results : Intention to treat analysis was used . There was significantly more movement to “ less depressed ” levels of depression at follow up in the intervention than control group ( Mantel-Haenszel stratification test , P=0.0125 ) . Multiple linear regression analysis found a significant intervention effect after controlling for possible confounders , with the intervention group showing an average improvement of 1.87 points on the geriatric depression scale compared with the control group ( 95 % confidence interval 0.76 to 2.97 , P=0.0011 ) . Conclusions : The outcome of depression among elderly people in residential care can be improved by multidisciplinary collaboration , by enhancing the clinical skills of general practitioners and care staff , and by providing depression related health education and activity programmes for residents . Key messages Large numbers of depressed elderly people live in residential care but few receive appropriate management A population based , multifaceted shared care intervention for late life depression was more effective than routine care in improving depression outcome The outcome of late life depression can be improved by enhancing the clinical skills of general practitioners and care staff and by providing depression related health education and activity programmes for residents The intervention needs further refining and evaluation to improve its effectiveness and to determine how best to implement it in other residential care setting OBJECTIVE To examine whether depressive symptoms in older adults contribute to increased cost of general medical services . DESIGN A 4-year prospect i ve cohort study . SETTING Four primary care clinics of a large staff-model health maintenance organization ( HMO ) in Seattle , Wash. PATIENTS A total of 5012 Medicare enrollees older than 65 years were invited to participate in the study ; 2558 subjects ( 51 % ) were successfully enrolled . Non- participants were somewhat older and had a higher level of chronic medical illness . MAIN OUTCOME MEASURES Depressive symptoms as measured by the Center for Epidemiological Studies Depression scale , which was administered as part of a mail survey at baseline , at 2 years , and at 4 years ; and total cost of medical services from the perspective of the HMO . Data were obtained from the cost accounting system of the HMO . RESULTS In this cohort of older adults , depressive symptoms were common , persistent , and associated with a significant increase in the cost of general medical services . This increase was seen for every component of health care costs and was not accounted for by an increase in specialty mental health care . The increase in health care costs remained significant after adjusting for differences in age , sex , and chronic medical illness . CONCLUSIONS Depressive symptoms in older adults are associated with a significant increase in the cost of medical services , even after adjusting for the severity of chronic medical illness Depression in elderly people is a common yet treatable psychiatric problem . The Gospel Oak depression study research ed this much overlooked group and has shown that a community psychiatric nurse ( CPN ) was able significantly to improve the mental state of depressed elderly people . A multifaceted package of care was co-ordinated and delivered by one CPN over a study period of 3 months . A detailed account is given of those interventions implemented , highlighting those which were of most benefit for the patient . Outcome was assessed independently and it was found that those patients allocated to CPN care improved significantly compared to the non-intervention control group . Ways in which nurses can enhance care given to patients in the community are discussed OBJECTIVE To examine treatment for depression among older adults in a large staff model health maintenance organization ( HMO ) . DESIGN A 4-year prospect i ve cohort study ( 1989 - 1993 ) . SETTING Four primary care clinics of a large staff model HMO in Seattle , Washington . PATIENTS A total of 2558 Medicare enrollees aged 65 and older . MAIN OUTCOME MEASURES Treatment of depression was defined as primary care visits result ing in depression diagnoses , use of antidepressant medications , or specialty mental health services . MAIN RESULTS
Output:
| Twelve studies ( five r and omized controlled trials , one quasi-experimental study , and six uncontrolled cohort studies ) found that home and community-based treatment of psychiatric symptoms were associated with improved or maintained psychiatric status .
CONCLUSIONS Limited data supported the effectiveness of outreach services in identifying isolated older adults with mental illness .
A more substantial evidence base indicated that home-based mental health treatment is effective in improving psychiatric symptoms . |
MS210907 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: In earlier studies of Astra Tech and Brånemark System implants , high survival rates and small marginal bone changes have been demonstrated . The aim of this study was to compare the two systems , primarily with regard to marginal bone changes , but also with regard to other clinical variables of interest . The present paper describes the results after three years . Sixty-six patients were included in the study and r and omly assigned to treatment with Astra Tech implants ( n = 184 ) or Brånemark System implants ( n=187 ) . The marginal bone level was radiographically examined at fixture insertion , at abutment connection , at baseline ( delivery of the prosthetic construction ) and at 1- and 3-year follow-up examinations . Between fixture insertion and the baseline examination , the pattern of marginal bone resorption differed between the two systems . However , there was no significant marginal bone change between baseline and the 1-year examination or between the 1- and 3-year examinations . Nor were there any differences between the systems . The mean bone loss in the upper jaw between BL ( baseline ) and 3 years was 0.2 + /- 0.3 mm for Astra Tech implants and 0.2 + /- 0.1 mm for Brånemark System implants . The corresponding figures for the lower jaw were 0.3 + /- 0.2 mm and 0.2 + /- 0.1 mm . The survival rate of Astra Tech implants was significantly higher ( 98.9 % ) than for Brånemark System implants ( 95.2 % ) . However , five of the nine implant losses in the Brånemark group occurred in one patient . For that reason , this result must be interpreted with caution . The number of patients with implant losses did not differ significantly between the systems . Few complications were recorded up to 3 years This paper describes the 5-year results of a comparative study between Astra Tech and Brånemark system implants . The aim was to compare the systems primarily with regard to bone level changes , and also with regard to other variables of interest . Sixty-six patients with edentulous jaws were included in the study . R and omisation schedules were used to allocate the patients to the two implant systems . 184 Astra Tech implants with a titanium-blasted surface and 187 Brånemark implants with a turned surface were used . The implants were inserted with a two-stage technique and the insertion followed the routines for the respective implant system . All patients were provided with full-arch fixed bridges . All patients were followed up with clinical and radiographic examinations from fixture insertion to the 5-year follow-up . The total mean bone level change in the upper jaw between fixture insertion and the 5-year examination was -1.74+/-0.45 mm at the Astra implants and -1.98+/-0.21 at the Brånemark implants . The corresponding values for the lower jaw were -1.06+/-0.19 for Astra and -1.38+/-0.17 for Brånemark . The major postoperative changes of the marginal bone level took place between fixture insertion and baseline . During this period , there was also a different pattern of bone remodelling between the implant systems . Between baseline ( prosthesis connection ) and the 5-year examination , the marginal bone level changes were small , with no difference between the implant systems . The implant stability was examined with the supraconstructions removed . At the 5-year examination , the survival rate for Astra Tech implants was 98.4 % and for the Brånemark implants it was 94.6 % . The difference was not statistically significant OBJECTIVE The purpose of this article was to present the preliminary results of a prospect i ve clinical trial comparing titanium plasma-sprayed versus hydroxyapatite-coated titanium plasma-sprayed cylinder ( press fit ) implants in different regions of the mouth . STUDY DESIGN Sixty-five subjects met the inclusion requirements . Surgery was done in two phases by four experienced surgeons . Implant placement and abutment connection were separated by 3 to 4 months in the m and ible , 6 to 7 months in the maxilla . Patients were assigned to either titanium plasma-sprayed or hydroxyapatite-coated implants on the day of surgery . Implant placement was not stratified for the region of the jaws . Outcome assessment was failure ( loss ) of an implant before or within 3 months of second phase surgery . RESULTS Three hundred fifty-two implants equally distributed between titanium plasma-sprayed and hydroxyapatite-coated titanium plasma-sprayed implants were placed in four different sites ; anterior maxilla , posterior maxilla , anterior m and ible , and posterior m and ible . There were a total of 15 failures ( 4.26 % ) . Overall , titanium plasma-sprayed implants showed a higher but not significant failure rate compared with hydroxyapatite-coated implants ( p = 0.06 ) . Although not statistically significant , we believe that a smoking history played an important role in the failure of implants . CONCLUSION This study suggests that an hydroxyapatite-coating of an implant allows superior initial integration when compared with a titanium plasma-sprayed surface BACKGROUND Step-wise reduction in loading protocol s is necessary to evaluate early loading of implants with m and ibular overdentures . PURPOSE To compare the success rates of two different dental implant systems following conventional or early loading protocol s in patients being rehabilitated with m and ibular overdentures . MATERIAL S AND METHODS Forty-eight edentulous participants were r and omly allocated to two different implant systems : one with a machined titanium implant surface ( Sterioss , Nobel Biocare , Yorba Linda , California , USA ) and the other with a roughened titanium surface ( Southern Implants , Irene , South Africa ) . For each system , the participants were further divided into control groups , in whom m and ibular implant overdentures and their respective matrices were inserted following a st and ard 12-week healing period , and test groups , in whom a 6-week healing period was followed prior to identical loading . Two unsplinted implants to support implant overdentures were placed in the anterior m and ible of all participants , using a st and ardized one-stage surgical procedure . Mobility tests and marginal bone levels , as well as peri-implant parameters , were evaluated at each baseline and 52 and 104 weeks after surgery . RESULTS There was no statistically significant difference in the success rates of the two systems in either control or test groups . At the 2-year evaluation , a success rate was found of 87.5 % and 70.8 % for the control and test Sterioss groups , respectively , and 83.3 % and 100 % for the control and test Southern Implants groups were observed . For the Sterioss groups , eight implants were lost at an early stage : seven in the test group and one in the control group . For the Southern Implants control and test groups , no failures were seen at any time interval . There were no significant differences in marginal bone loss , Periotest values , and peri-implant parameters between implant systems or between any of the control or test groups . CONCLUSIONS Early loading , with step-wise reductions in loading protocol s , of unsplinted machined Sterioss and roughened Southern Implants fixtures with m and ibular overdentures is possible for up to 2 years BACKGROUND Evidence -based reports are needed to support the application of a one-stage surgical protocol for unsplinted implants supporting m and ibular overdentures . PURPOSE To examine the feasibility and success of using two different dental implant systems ( originally design ed for two-stage operative technique ) using a one-stage operative procedure in patients being rehabilitated with implant m and ibular overdentures . MATERIAL S AND METHODS The study sample involved 24 edentulous subjects ( aged 55 - 80 yr ) r and omly allocated to two different implant systems , one with a machined titanium implant surface ( Steri-Oss , Nobel Biocare , Göteborg , Sweden ) and the other with a roughened titanium surface ( Southern Implants , Ltd. , Irene , South Africa ) . Two unsplinted implants to support implant overdentures were placed in the anterior m and ible of all patients , using a st and ardized one-stage surgical and prosthodontic procedure . Primary stability and bicortical anchorage of the implants was m and atory before healing abutments were connected at the time of implant placement . Implant overdentures and their respective matrices were inserted following a st and ard 12-week healing period . Data relating to mobility tests , radiographs , and peri-implant parameters were documented at 12 , 16 , and 52 weeks after surgery . RESULTS A success rate of 95.8 % for the Steri-Oss and 100 % for the Southern Implants was found , without any statistically significant differences in the marginal bone loss . Significant changes in Periotest values were observed for both types between 12 and 52 weeks ( p < .001 ) . Minor changes were observed in the peri-implant parameters evaluated . CONCLUSIONS These preliminary findings show a successful application of this one-stage approach for unsplinted implants supporting m and ibular overdentures with Steri-Oss and Southern Implant Systems BACKGROUND Many longitudinal studies of different implant systems have been published but few controlled r and omized investigations have been reported . A 1-year report of a comparative study of ITI Dental Implant System implants ( Straumann AG , Waldenburg , Switzerl and ) and Brånemark System implants ( Nobel Biocare AB , Gothenburg , Sweden ) has been published by the present authors . This paper is a 3-year follow-up of that r and omized study . PURPOSE The aim of the study was to compare the outcome of fixed partial prostheses supported by ITI or Brånemark implants . The outcome was evaluated primarily in terms of survival rates and changes in marginal bone level . MATERIAL AND METHODS The study group comprised 28 patients with anterior residual dentition in the maxilla . The patients were provided with two to four implants on each side of the dentition and were r and omly allocated to Brånemark implants or ITI implants ; 77 ITI implants and 73 Brånemark implants were inserted . After 6 months abutment connections were made to both ITI and Brånemark implants . All patients were provided with fixed partial prostheses of gold-ceramic . The patients were followed up annually with clinical and radiographic examinations for 3 years RESULTS Two Brånemark implants and two ITI implants were lost . The Brånemark implants were lost before loading whereas the ITI implants were lost because of periimplantitis . The survival rate for both groups was 97.3 % . The mean marginal bone level of the Brånemark implants was situated 1.8 mm from the reference point at both the baseline and the 3-year examinations . The corresponding values for the ITI implants were 1.4 mm at baseline and 1.3 mm after 3 years . There was no significant difference between the implant systems with regard to bone level or bone level change . A steady state of the marginal bone level was calculated to have been reached after 3 years for 95.5 % of the Brånemark implants and 87.1 % of the ITI implants . Periimplantitis ( infection including pus and bone loss ) was observed with seven ITI implants but with none of the Brånemark implants . This difference was statistically significant . CONCLUSIONS No statistically significant differences were found between the implants studied , except for the frequency of periimplantitis , which was higher for the ITI implants . The survival rates were high , and the marginal bone loss was small for both systems The aim of this prospect i ve comparative study was to evaluate the condition of the peri-implant tissues of three different implant systems supporting a m and ibular overdenture . Ninety edentulous patients ( Cawood class V-VI ) participated in this study . After r and omization , 30 patients were treated with 2 Brånemark implants , 30 patients with 2 IMZ implants and 30 patients with 2 ITI implants . The implants were inserted in the canine region of the m and ible . After 3 months overdentures were fabricated supported by a round bar and clip attachment . A st and ardized clinical and radiographic evaluation was performed 0,6 and 12 months after insertion of the denture . The intraoral radiographs were made , using the long-cone technique with an aim ing device . Two implants were lost ( 1 Brånemark , 1 IMZ ) during the healing period . None of the patients showed any sensory change in lip or chin region . The pocket depth in the Brånemark group decreased significantly whereas the mucosa recession increased significantly in both the Brånemark as well as in the IMZ group . After 12 months , there was significantly less bone loss in the ITI group . From our study it was concluded that 2 ( Brånemark , IMZ or ITI ) implants placed in the interforaminal region connected with a bar supply a proper base for the support of a m and ibular overdenture in the ( Cawood V-VI ) edentulous patient . The ITI implant appears to be the implant of choice for m and ibular overdenture therapy , because only one operation is required for a comparable result PURPOSE Although no currently available technique for the measurement of osseointegration is entirely satisfactory , 3 clinical variables can be reasonably associated with the process : probing depth , micromobility , and crestal bone height . Micromobility can be quantified to some extent with the use of the Periotest , a commercially available instrument In this investigation , the influence of surface characteristics and geometry upon Periotest value ( PTV ) and probing depth measurements was studied . MATERIAL S AND METHODS In a multicenter trial , 120 healthy edentulous patients received 5 or 6 implants in the anterior m and ible and were followed for 3 years . A total of 634 implants were placed . Every patient received at least 1 implant of each of
Output:
| DISCUSSION AND CONCLUSIONS There were no clinical differences among implant systems . |
MS210908 | ***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: Facial expression recognition is a central feature of emotional and social behaviour and previous studies have found that alcoholics are impaired in this skill when presented with single emotions of differing intensities . The aim of this study was to explore biases in alcoholics ' recognition of emotions when they were a mixture of two closely related emotions . The amygdala is intimately involved in encoding of emotions , especially those related to fear . In animals an increased number of withdrawals from alcohol leads to increased seizure sensitivity associated with facilitated transmission in the amygdala and related circuits . A further objective therefore was to explore the effect of previous alcohol detoxifications on the recognition of emotional facial expressions . Fourteen alcoholic in patients were compared with 14 age and sex matched social drinking controls . They were asked to rate how much of each of six emotions ( happiness , surprise , fear , sadness , disgust and anger ) were present in morphed pictures portraying a mix of two of those emotions . The alcoholic group showed enhanced fear responses to all of the pictures compared to the controls and showed a different pattern of responding on anger and disgust . There were no differences between groups on decoding of sad , happy and surprised expressions . In addition the enhanced fear recognition found in the alcoholic group was related to the number of previous detoxifications . These results provide further evidence for impairment in facial expression recognition present in alcoholic patients . In addition , since the amygdala has been associated with the processing of facial expressions of emotion , particularly those of fear , the present data furthermore suggest that previous detoxifications may be related to changes within the amygdala Most studies investigating the recognition of facial expressions have focused on static displays of intense expressions . Consequently , research ers may have underestimated the importance of motion in deciphering the subtle expressions that permeate real-life situations . In two experiments , we examined the effect of motion on perception of subtle facial expressions and tested the hypotheses that motion improves affect judgment by ( a ) providing denser sampling of expressions , ( b ) providing dynamic information , ( c ) facilitating configural processing , and ( d ) enhancing the perception of change . Participants viewed faces depicting subtle facial expressions in four modes ( single-static , multi-static , dynamic , and first-last ) . Experiment 1 demonstrated a robust effect of motion and suggested that this effect was due to the dynamic property of the expression . Experiment 2 showed that the beneficial effect of motion may be due more specifically to its role in perception of change . Together , these experiments demonstrated the importance of motion in identifying subtle facial expressions OBJECTIVE To describe patterns of alcohol consumption in the adult Brazilian population . METHOD Multicluster r and om sample of 2,346 subjects 18 years of age or older , selected nationwide . Interviews were conducted in respondents ' homes between November 2005 and April 2006 . RESULTS About 48 % of the sample had not drunk alcoholic beverages in the past year , with variations by gender , age , marital status , education , income and region of the country . Among drinkers , 29 % reported drinking 5 or more drinks per occasion ( men , 38 % ) . Sociodemographic variables are associated with the frequency and amount of drinking , alcohol problems , and alcohol abuse and dependence . Among the whole sample ( including drinkers and non drinkers ) , 28 % reported binge drinking , 25 % reported at least one kind of alcohol related problem , 3 % were alcohol abusers and another 9 % were alcohol dependent . DISCUSSION Abstinence is high in the Brazilian population . However , elevated proportions of those who drink consume alcohol in a high risk pattern ( binge-drinking ) , report a high level of alcohol problems , alcohol abuse and dependence . National public policies must consider these factors , as well as the regional Brazilian differences
Output:
| RESULTS The findings of some studies indicate that alcoholics have greater impairment in facial expression recognition tasks , while others could not differentiate the clinical group from controls .
However , there was a trend toward greater deficits in alcoholics .
Alcoholics displayed less accuracy in recognition of sadness and disgust and required greater emotional intensity to judge facial expressions corresponding to fear and anger . |
MS210909 | ***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 Despite evidence that a variety of continuing medical education ( CME ) techniques can foster physician behavioral change , there have been no r and omized trials comparing performance outcomes for physicians participating in Internet-based CME with physicians participating in a live CME intervention using approaches documented to be effective . OBJECTIVE To determine if Internet-based CME can produce changes comparable to those produced via live , small-group , interactive CME with respect to physician knowledge and behaviors that have an impact on patient care . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled trial conducted from August 2001 to July 2002 . Participants were 97 primary care physicians drawn from 21 practice sites in Houston , Tex , including 7 community health centers and 14 private group practice s. A control group of 18 physicians from these same sites received no intervention . INTERVENTIONS Physicians were r and omly assigned to an Internet-based CME intervention that could be completed in multiple sessions over 2 weeks , or to a single live , small-group , interactive CME workshop . Both incorporated similar multifaceted instructional approaches demonstrated to be effective in live setting s. Content was based on the National Institutes of Health National Cholesterol Education Program -- Adult Treatment Panel III guidelines . MAIN OUTCOME MEASURES Knowledge was assessed immediately before the intervention , immediately after the intervention , and 12 weeks later . The percentage of high-risk patients who had appropriate lipid panel screening and pharmacotherapeutic treatment according to guidelines was documented with chart audits conducted over a 5-month period before intervention and a 5-month period after intervention . RESULTS Both interventions produced similar and significant immediate and 12-week knowledge gains , representing large increases in percentage of items correct ( pretest to posttest : 31.0 % [ 95 % confidence interval { CI } , 27.0%-35.0 % ] ; pretest to 12 weeks : 36.4 % [ 95 % CI , 32.2%-40.6 % ] ; P<.001 for all comparisons ) . Chart audits revealed high baseline screening rates in all study groups ( > or = 93 % ) with no significant postintervention change . However , the Internet-based intervention was associated with a significant increase in the percentage of high-risk patients treated with pharmacotherapeutics according to guidelines ( preintervention , 85.3 % ; postintervention , 90.3 % ; P = .04 ) . CONCLUSIONS Appropriately design ed , evidence -based online CME can produce objective ly measured changes in behavior as well as sustained gains in knowledge that are comparable or superior to those realized from effective live activities Purpose To evaluate a five-year experience ( 1995–2000 ) developing and integrating computer cases into a required clerkship . Method In Study 1 , 54 volunteer students were r and omly assigned to study articles , a paper case , or a computer case on low back pain/kidney stones . Students were given an exam immediately after the exercise and one week later . In Study 2 , 325 clerkship students were asked to select and complete two computer cases or to prepare assignments on unrelated topics . Among the cases offered were two test cases on low back pain/kidney stones and pneumonia . Questions specific to the computer test cases ( CC ) and other noncomputer cases ( NCC ) were in the final exam . Exam scores related to CC questions and NCC questions were compared between the groups of students who did and did not complete the computer cases . Students also rated the computer cases on a question naire . Results In Study 1 , reading articles required the most time and received the most negative comments . The students who completed the computer case scored the best on the exam one week later . In Study 2 , the students who completed the two computer cases scored significantly higher on the CC questions than did students who studied only one or none of the computer cases ( p < .001 ) . There was no difference among groups for the NCC scores ( p = .76 ) . Students rated the computer cases with a mean of 6 on a seven-point scale ( 7 = strongly agree ) . Conclusion Computer cases are effective learning tools , are well-received by students , and can be successfully integrated into existing clerkships INTRODUCTION The use of computer-generated 3-dimensional ( 3-D ) anatomical models to teach anatomy has proliferated . However , there is little evidence that these models are educationally effective . The purpose of this study was to test the educational effectiveness of a computer-generated 3-D model of the middle and inner ear . METHODS We reconstructed a fully interactive model of the middle and inner ear from a magnetic resonance imaging scan of a human cadaver ear . To test the model 's educational usefulness , we conducted a r and omised controlled study in which 28 medical students completed a Web-based tutorial on ear anatomy that included the interactive model , while a control group of 29 students took the tutorial without exposure to the model . At the end of the tutorials , both groups were asked a series of 15 quiz questions to evaluate their knowledge of 3-D relationships within the ear . RESULTS The intervention group 's mean score on the quiz was 83 % , while that of the control group was 65 % . This difference in means was highly significant ( P < 0.001 ) . DISCUSSION Our findings st and in contrast to the h and ful of previous r and omised controlled trials that evaluated the effects of computer-generated 3-D anatomical models on learning . The equivocal and negative results of these previous studies may be due to the limitations of these studies ( such as small sample size ) as well as the limitations of the models that were studied ( such as a lack of full interactivity ) . Given our positive results , we believe that further research is warranted concerning the educational effectiveness of computer-generated anatomical models Background : Although animations may intuitively seem more effective than static graphics for teaching , there is no clear-cut evidence for the superiority of simple computer-based animations in medical education . Aims : We investigated whether simple animations are better than static graphics as an aid to medical students in learning home safety assessment , an important part of geriatric curriculum . Methods : We used two versions of an interactive online module , one that depicted common home safety issues in static graphics and the other in animations . We r and omized first-year medical students who agreed to participate into two groups . After the module , students completed a cognitive burden scale and a st and ardized competency assessment test in which they had to identify the salient home safety issues and give recommendations based on the hazards . We also captured time spent on task . Results and conclusions : We found no significant differences between the groups in the cognitive burden level , competency assessment scores , and time spent on task . The much cheaper-to-produce static graphics were equally effective as simple animations in this medical education scenario BACKGROUND Video-based instructions for clinical procedures have been used frequently during the preceding decades . AIM To investigate in a r and omised controlled trial the learning effectiveness of fragmented videos vs. the complete sequential video and to analyse the attitudes of the user towards video as a learning aid . MATERIAL S AND METHODS An instructional video on surgical h and wash was produced . The video was available in two different forms in two separate web pages : one as a sequential video and one fragmented into eight short clips . Twenty-eight dental students in the second semester were r and omised into an experimental ( n = 15 ) and a control group ( n = 13 ) . The experimental group used the fragmented form of the video and the control group watched the complete one . The use of the videos was logged and the students were video taped whilst undertaking a test h and wash . The videos were analysed systematic ally and blindly by two independent clinicians . The students also performed a written test concerning learning outcome from the videos as well as they answered an attitude question naire . RESULTS The students in the experimental group watched the video significantly longer than the control group . There were no significant differences between the groups with regard to the ratings and scores when performing the h and wash . The experimental group had significantly better results in the written test compared with those of the control group . There was no significant difference between the groups with regard to attitudes towards the use of video for learning , as measured by the Visual Analogue Scales . Most students in both groups expressed satisfaction with the use of video for learning . CONCLUSION The students demonstrated positive attitudes and acceptable learning outcome from viewing CAL videos as a part of their pre- clinical training . Videos that are part of computer-based learning setting s would ideally be presented to the students both as a segmented and as a whole video to give the students the option to choose the form of video which suits the individual student 's learning style OBJECTIVE To determine the impact of adding audio-feed to an online lecture on screening given to medical students who were participating in an outpatient clerkship . DESIGN Prospect i ve , r and omised , controlled study . SETTING V and erbilt University School of Medicine , Nashville and Wake Forest Medical School , Winston-Salem . PARTICIPANTS A total of 59 Years 3 and 4 medical students . MAIN OUTCOME MEASURES Students ' use of time , satisfaction with the lecture experience , and knowledge . Educational intervention The online lecture was developed at V and erbilt University . At V and erbilt , 16 Year 4 medical students were r and omised to the lecture on screening with audio and 17 Year 4 medical students were r and omised to the same lecture without audio . At Wake Forest , 13 Year 3 medical students were r and omised to the lecture on screening with audio and 13 Year 3 students were r and omised to the same lecture without audio . RESULTS The audio lecture required 20 more minutes to complete than the non-audio lecture . Students in the audio group were more satisfied with their experience than students in the non-audio group . Students in the audio-feed group achieved a trend for higher post-intervention knowledge scores , with the difference attributed to the students at V and erbilt . CONCLUSION Audio narration is an important aspect of an online lecture . The distribution of online lectures to students at different sites and different training levels requires further study Purpose To determine whether internal medicine residents prefer learning from Web-based ( WB ) modules or printed material , and to compare the effect of these teaching formats on knowledge . Method The authors conducted a r and omized , controlled , crossover study in the internal medicine resident continuity clinics of the Mayo School of Graduate Medical Education during the 2002–03 academic year . Participants studied two topics of ambulatory medicine using WB modules and two topics using paper practice guidelines in r and omly assigned sequences . Primary outcomes were format preference ( assessed by an end-of-course question naire ) and score changes from pre- to postintervention tests of knowledge . Results A total of 109 consented and 75 ( 69 % ) completed the postintervention test . Fifty-seven of 73 ( 78 % “ 95 % CI , 67–86 % ” ) preferred the WB format ( p < .001 ) . Test scores improved for both formats ( 67.7 % to 75.0 % for WB , 66.0 % to 73.3 % for paper ) , but score change was not different between formats both before ( p = .718 ) and after ( p = .080 ) adjusting for topic , clinic site , study group , postgraduate year , and gender . Residents spent less time on WB modules ( mean = 47 ± 26 minutes ) than paper ( mean = 59 ± 35 , p = .024 ) . Difficulties with passwords limited their use of WB modules for 71 % ( 59–80 % ) of residents . Conclusion No difference was found between WB and paper-based formats in knowledge-test score change , but residents preferred learning with WB modules and spent less time doing so . Passwords appeared to impede use of WB modules . WB learning is effective , well accepted , and efficient . Research should focus on aspects of WB instruction that will enhance its power as a learning tool and better define its role in specific setting Multimedia instruction offers many potential advantages over traditional methods of instruction . Multimedia programs can interact with the learner , use graphic images , sound , and video , and keep track of progress . Students complete programs at their own pace while accessing material both at school and at home . Multimedia instruction can provide an interactive alternative to lectures and textbooks by quizzing the student over concepts as they are presented and requiring that the student think about the material before proceeding . While several studies have found that multimedia instruction can be more efficient by reducing instructor and classroom time , few have been able to show an increase in learning when compared with traditional methods of instruction . Santer and colleagues compared a multimedia textbook with a lecture presentation on the same material and found an increase in the post-test scores of the multimedia group , but no difference when they compared the multimedia group with a group using a printed textbook . Studies comparing multimedia and traditional approaches to learning in the areas of psychology and computer science instruction suggest an improvement in students ’ performances using the multimedia versions . Thus , there is a need for well- design ed studies to determine whether multimedia instruction more effectively facilitates students ’ learning — including medical students ’ learning — than do traditional methods . Multimedia instruction is particularly well suited to help students learn physical diagnosis . Sound , pictures , and movies augment the learning of examination skills and diagnosis findings by allowing students to hear heart and lung sounds , watch videos of physical examination procedures , and see more pictures of pathologic findings than can be included in a textbook or lecture . These visual and audio aids should increase students ’ recognition of these findings when encountered in patients . We wished to test whether a Web-based multimedia program using interactive learning and virtual reality would be more efficient and effective than traditional print-based self- study by medical students . To accomplish this , we design ed a course on physical examination of the eye and ear . Using this material , we conducted a controlled study of first-year medical students to determine whether having students use a multimedia version of the course result ed in a change in the time spent with the material and an increase in knowledge gained when compared with having students study a printed version of the same material OBJECTIVES A case-based , worked example approach was realised in a computer-based learning environment with the intention of facilitating medical students ' diagnostic knowledge . In order to enhance the effectiveness of the approach , two additional measures were implemented : erroneous examples and elaborated feedback . In the context of an experimental study , the two measures were varied experimentally . METHODS A total of 153 medical students were r and omly assigned to four experimental conditions of a 2 x 2-factor design ( errors versus no errors , elaborated feedback
Output:
| Other studies revealed that audio narration , video clips , interactive models , and animations increase learning time but also facilitate higher knowledge and /or satisfaction .
Conclusions On average , Internet-based instruction and non-computer instruction require similar time .
Instructional strategies to enhance feedback and interactivity typically prolong learning time , but in many cases also enhance learning outcomes .
Isolated examples suggest potential for improving efficiency in Internet-based instruction |
MS210910 | ***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 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 BACKGROUND Epidemiologic studies have shown alcohol consumption to be inversely as well as positively related to body weight and body fat . Metabolic studies have shown an increase in energy intake as well as compensation after alcohol consumption . OBJECTIVE Our objective was to assess the effects on energy intake of an apéritif compared with those of a water appetizer and 3 fruit juice appetizers . DESIGN Fifty-two men and women aged 20 - 45 y with a body mass index ( in kg/m2 ) between 20 and 32 were r and omly given 1 MJ ( 340 mL ) alcohol ( wine or beer ) , fat ( cream fruit juice ) , protein ( protein fruit juice ) , carbohydrate ( grape juice ) , or water , or no preload 30 min before an ad libitum lunch consumed from the universal eating monitor . RESULTS Energy intake ( 3.5+/-0.3 MJ compared with 2.7+/-0.2 MJ , P < 0.001 ) and eating rate were higher ( 44+/-3 g/min compared with 38+/-3 g/min , P < 0.01 ) , meal duration was longer ( 14 min compared with 12.0 min , P < 0.01 ) , satiation started to increase later ( 3.5 min compared with 1.5 min , P < 0.01 ) , and eating was prolonged after maximum satiation ( 2.5 min compared with 0.6 min , P < 0.01 ) after an apéritif than after a fat , protein , or carbohydrate appetizer , . Twenty-four-hour energy intake was higher on a day that an apéritif was consumed than after water or no preload . CONCLUSION Twenty-four-hour energy intake was elevated with a 1-MJ apéritif but not with a 1-MJ liquid carbohydrate , fat , or protein appetizer We studied the effects of xylitol , the pentose-sugar alcohol , on gastric emptying of the solid-food component of a complex meal . Gastric emptying was measured in human volunteers by utilizing a st and ardized radiolabeled scrambled-egg meal . After ingestion of 25 g xylitol , gastric emptying was markedly prolonged ( T-1/2 58 + /- 5 min control vs 91 + /- 7 min after xylitol [ p less than 0.01 ] ) . Since delayed gastric emptying may affect food intake , we evaluated the effects of xylitol on calorie intake . Food intake after oral preloading with water result ed in intake of 920 + /- 60 kcal vs 690 + /- 45 kcal after 25 g of xylitol . In contrast , a preload of glucose , fructose , or sucrose failed to suppress food intake . Although xylitol decreased food intake and also delayed gastric emptying , these effects may be unrelated . Our data suggest a role for xylitol as a potentially important agent in dietary control Using a within-subjects design , we gave over-weight and normal-weight subjects a 500-mL drink of fructose , glucose , or aspartame diluted in lemon-flavored water or plain water in a r and omized fashion at about weekly intervals . Food intake was assessed at a buffet lunch that began 38 min after the preload was completed . Blood was drawn throughout and assayed for concentrations of glucose , insulin , glucagon , and free fatty acid . When subjects drank the fructose preload , they subsequently ate fewer overall calories and fewer grams of fat than when they drank any of the other preloads . The aspartame load did not stimulate intake beyond the plain-water control . The effects of the oxidation of fructose as a possible mechanism for the reduction in food intake is discussed . The effects of insulin in stimulating intake are also discussed BACKGROUND Previous studies have linked full-calorie sugar-sweetened beverages ( SSBs ) with greater weight gain and an increased risk of type 2 diabetes . OBJECTIVE We prospect ively examined the association between consumption of SSBs and the risk of coronary heart disease ( CHD ) in women . DESIGN Women ( n = 88,520 ) from the Nurses ' Health Study aged 34 - 59 y , without previously diagnosed coronary heart disease ( CHD ) , stroke , or diabetes in 1980 , were followed from 1980 to 2004 . Consumption of SSBs was derived from 7 repeated food-frequency question naires administered between 1980 and 2002 . Relative risks ( RRs ) for CHD were calculated by using Cox proportional hazards models and adjusted for known cardiovascular disease risk factors . RESULTS During 24 y of follow-up , we ascertained 3105 incident cases of CHD ( nonfatal myocardial infa rct ion and fatal CHD ) . After st and ard and dietary risk factors were adjusted for , the RRs ( and 95 % CIs ) of CHD according to categories of cumulative average of SSB consumption ( < 1/mo , 1 - 4/mo , 2 - 6/wk , 1/d , and > or = 2 servings/d ) were 1.0 , 0.96 ( 0.87 , 1.06 ) , 1.04 ( 0.95 , 1.14 ) , 1.23 ( 1.06 , 1.43 ) , and 1.35 ( 1.07 , 1.69 ) ( P for trend < 0.001 ) . Additional adjustment for body mass index , energy intake , and incident diabetes attenuated the associations , but they remained significant . Artificially sweetened beverages were not associated with CHD . CONCLUSION Regular consumption of SSBs is associated with a higher risk of CHD in women , even after other unhealthful lifestyle or dietary factors are accounted for BACKGROUND Type 2 diabetes mellitus is an increasingly serious health problem among African American women . Consumption of sugar-sweetened drinks was associated with an increased risk of diabetes in 2 studies but not in a third ; however , to our knowledge , no data are available on African Americans regarding this issue . Our objective was to examine the association between consumption of sugar-sweetened beverages , weight gain , and incidence of type 2 diabetes mellitus in African American women . METHODS A prospect i ve follow-up study of 59,000 African American women has been in progress since 1995 . Participants reported on food and beverage consumption in 1995 and 2001 . Biennial follow-up question naires ascertained new diagnoses of type 2 diabetes . The present analyses included 43,960 women who gave complete dietary and weight information and were free from diabetes at baseline . We identified 2713 incident cases of type 2 diabetes mellitus during 338,884 person-years of follow-up . The main outcome measure was the incidence of type 2 diabetes mellitus . RESULTS The incidence of type 2 diabetes mellitus was higher with higher intake of both sugar-sweetened soft drinks and fruit drinks . After adjustment for confounding variables including other dietary factors , the incidence rate ratio for 2 or more soft drinks per day was 1.24 ( 95 % confidence interval , 1.06 - 1.45 ) . For fruit drinks , the comparable incidence rate ratio was 1.31 ( 95 % confidence interval , 1.13 - 1.52 ) . The association of diabetes with soft drink consumption was almost entirely mediated by body mass index , whereas the association with fruit drink consumption was independent of body mass index . CONCLUSIONS Regular consumption of sugar-sweetened soft drinks and fruit drinks is associated with an increased risk of type 2 diabetes mellitus in African American women . While there has been increasing public awareness of the adverse health effects of soft drinks , little attention has been given to fruit drinks , which are often marketed as a healthier alternative to soft drinks Objective : The purpose of this study was to compare the dietary strategies , and use of fat- and sugar-modified foods and beverages in a weight loss maintainer group ( WLM ) and an always-normal weight group (NW).Subjects : WLM ( N=172 ) had maintained ⩾10 % weight loss for 11.5 years , and had a body mass index ( BMI ) of 22.0 kg m−2 . NW ( N=131 ) had a BMI of 21.3 kg m−2 and no history of being overweight . Three , 24-h recalls on r and om , non-consecutive days were used to assess dietary intake . Results : WLM reported consuming a diet that was lower in fat ( 28.7 vs 32.6 % , P<0.0001 ) and used more fat-modification strategies than NW . WLM also consumed a significantly greater percentage of modified dairy ( 60 vs 49 % ; P=0.002 ) and modified dressings and sauces ( 55 vs 44 % ; P=0.006 ) than NW . WLM reported consuming three times more daily servings of artificially sweetened soft drinks ( 0.91 vs 0.37 ; P=0.003 ) , significantly fewer daily servings of sugar-sweetened soft drinks ( 0.07 vs 0.16 ; P=0.03 ) and more daily servings of water ( 4.72 vs 3.48 ; P=0.002 ) than NW . Conclusions : These findings suggest that WLM use more dietary strategies to accomplish their weight loss maintenance , including greater restriction on fat intake , use of fat- and sugar-modified foods , reduced consumption of sugar-sweetened beverages and increased consumption of artificially sweetened beverages . Ways to promote the use of fat-modified foods and artificial sweeteners merits further research in both prevention- and treatment-controlled trials Water consumed before a meal has been found to reduce energy intake among nonobese older adults . However , it is unknown whether this effect is evident among overweight and obese older adults , a population who would benefit from strategies to improve energy intake regulation . Our purpose was to determine whether premeal water consumption reduces meal energy intake in overweight and obese older adults . Twenty-four overweight and obese adults ( body mass index=34.3+/-1.2 ) , mean age 61.3+/-1.1 years , were given an ad libitum st and ardized breakfast meal on two r and omly assigned occasions . Thirty minutes before the meal , subjects were given either a 500-mL water preload or no preload . Energy intake at each meal was covertly measured . Meal energy intake was significantly less in the water preload condition as compared with the no-preload condition ( 500+/-32 vs 574+/-38 , respectively ; P=0.004 ) , representing an approximate 13 % reduction in meal energy intake . The percentage reduction in meal energy intake following the water preload was not related to sex , age , body mass index , or habitual daily water consumption ( all P>0.05 ) . Given the high prevalence of overweight and obesity among older adults , future studies should determine whether premeal water consumption is an effective long-term weight control strategy for older adults CONTEXT Recently , we showed that drinking 500 ml water induces thermogenesis in normal-weight men and women . OBJECTIVE We now repeated these studies in a r and omized , controlled , crossover trial in overweight or obese otherwise healthy subjects ( eight men and eight women ) , comparing also the effects of 500 ml isoosmotic saline or 50 ml water . R
Output:
| These findings from clinical trials , along with those from epidemiologic and intervention studies , suggest water has a potentially important role to play in reducing energy intake , and consequently in obesity prevention . |
MS210911 | ***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 Soyfoods provide healthful options for school breakfasts and lunches that are lower in saturated fat , cholesterol , fat , and calories and can help meet dem and s for vegetarian choices . Research ers tested acceptance of soy-based options substituted for popular lunch items with a diverse student population . METHODS Research ers conducted a plate waste study in 5 middle schools in Montgomery County , Maryl and , to test the comparability of soy-based alternatives to 4 popular meat-based menu items . Initially , students ranked taste , appearance , and texture of 15 soyfoods to narrow to " hybrid " beef patties , soy-based nuggets , soy-based chicken-less slices , and soy macaroni and cheese . After the meal , trained observers r and omly tagged and collected trays with and without test items and weighed leftover entrées . Research ers used a proportional odds model to compare amounts and proportions of food consumed , and a mixed model to account for differences between schools . RESULTS Students consumed the same amount of soy-based and traditional patties , nuggets , and pasta , and less soy than regular chicken in the salad ( odds ratio 0.122 , p value < .0001 ) . Students consumed higher proportions ( p value < .05 ) of traditional chicken nuggets , beef patties , chicken slices , and pasta compared to soy-based alternative products . On average , soy-based entrées had fewer calories ; less total fat , saturated fat , and cholesterol ; and more iron , fiber , and sodium compared to traditional menu items . CONCLUSIONS This study indicates that middle school students readily consume almost equal numbers of soy-based products compared to popular school lunch items . Soyfoods provide nutritional advantages Recent changes in nutrition st and ards for the National School Lunch and School Breakfast Programs assume that modification of the nutritional serving practice s of school cafeterias will result in improved childhood nutrition in the school environment . The primary aim of this paper is to summarize the findings from two recent cluster r and omized controlled trials ( Wise Mind and LA Health ) that tested the hypothesis that modification of school cafeteria environments , including changes in nutrition st and ards , would yield beneficial changes in childhood nutrition and healthy eating in the school lunch environment . A secondary aim was to investigate the association of participant characteristics and changes in nutrition and healthy eating . A third aim was to investigate the relationships between the food intake of children and : ( 1 ) foods selected by the children and ( 2 ) food that was uneaten during the lunch meal ( plate waste ) . The studies used similar approaches for modifying the school cafeteria environment and both studies used the digital photography method to measure changes in food intake , food selection , and plate waste . Both studies reported significant improvements in childhood nutrition , and the LA Health study reported improved healthy eating , following introduction of the cafeteria modification program in comparison to baseline and /or control arms . These studies confirm the hypothesis that interventions that modify the school cafeteria environment can beneficially impact childhood nutrition Project FIT was a two-year multi-component nutrition and physical activity intervention delivered in ethnically-diverse low-income elementary schools in Gr and Rapids , MI . This paper reports effects on children ’s nutrition outcomes and process evaluation of the school component . A quasi-experimental design was utilized . 3rd , 4th and 5th- grade students ( Yr 1 baseline : N = 410 ; Yr 2 baseline : N = 405 ; age range : 7.5–12.6 years ) were measured in the fall and spring over the two-year intervention . Ordinal logistic , mixed effect models and generalized estimating equations were fitted , and the robust st and ard errors were utilized . Primary outcomes favoring the intervention students were found regarding consumption of fruits , vegetables and whole grain bread during year 2 . Process evaluation revealed that implementation of most intervention components increased during year 2 . Project FIT result ed in small but beneficial effects on consumption of fruits , vegetables , and whole grain bread in ethnically diverse low-income elementary school children BACKGROUND It is often assumed that children avoid fruit in school cafeterias because of higher relative prices and preferences for other foods . Interviews with children reveal that eating whole fresh fruit can be difficult for those with small mouths or braces . Older girls find whole fruits messy and unattractive to eat . PURPOSE To determine the effect of offering pre-sliced fruit in schools on selection and intake . DESIGN Three of six schools were assigned r and omly to serve apples in slices . Three control schools served apples whole . Selection , consumption , and waste of apples were measured prior to and during treatment . SETTING / PARTICIPANTS Cafeterias in six public middle schools in Wayne County NY in 2011 . Participants included all students who purchased lunch on days when data were collected . INTERVENTION Treatment schools were provided with a st and ard commercial fruit slicer , and cafeteria staff members were instructed to use it when students requested apples . Trained research ers recorded how much of each apple was consumed and how much was wasted in both control and treatment schools . MAIN OUTCOME MEASURES Daily apple sales , percentage of an apple serving consumed per student , and percentage of an apple serving wasted per student . RESULTS Data were analyzed in 2012 . Schools that used fruit slicers to pre-slice fruit increased average daily apple sales by 71 % compared to control schools ( p<0.01 ) . The percentage of students who selected apples and ate more than half increased by 73 % ( p=0.02 ) at schools that served pre-sliced fruit , and the percentage that wasted half or more decreased by 48 % ( p=0.03 ) . CONCLUSIONS Sliced fruit is more appealing to children than whole fruit because it is easier and tidier to eat . This study applies the principle of convenience from behavioral economics and provides an example of a scalable , low-cost environmental change that promotes healthy eating and decreases waste OBJECTIVE We sought to characterize student receptivity to new menu offerings in the Los Angeles Unified School District by measuring the levels of fruit and vegetable waste after implementation of changes to the school lunch menu in fall 2011 . METHODS We measured waste at four r and omly selected middle schools in the school district , using two sources : a ) food prepared and left over after service ( production waste ) ; and b ) food that was selected but not eaten by students ( plate waste ) . RESULTS 10.2 % of fruit and 28.7 % of vegetable items prepared at the four schools were left over after service . Plate waste data , collected from 2228 students , suggest that many of them did not select fruit ( 31.5 % ) or vegetable ( 39.6 % ) items . Among students who did , many threw fruit and vegetable items away without eating a single bite . CONCLUSIONS Our findings suggest that fruit and vegetable waste was substantial and that additional work may be needed to increase student selection and consumption of fruit and vegetable offerings . Complementary interventions to increase the appeal of fruit and vegetable options may be needed to encourage student receptivity to these healthier items in the school meal program OBJECTIVE To assess whether a Smarter Lunchroom intervention based on behavioural economics and adapted for students with intellectual and developmental disabilities would increase the selection and consumption of fruits , vegetables and whole grains , and reduce the selection and consumption of refined grains . DESIGN The 3-month intervention took place at a residential school between March and June 2012 . The evaluation employed a quasi-experimental , pre-post design comparing five matched days of dietary data . Selection and plate waste of foods at lunch were assessed using digital photography . Consumption was estimated from plate waste . SETTING Massachusetts , USA . SUBJECTS Students ( n 43 ) aged 11 - 22 years with intellectual and developmental disabilities attending a residential school . RESULTS Daily selection of whole grains increased by a mean of 0·44 servings ( baseline 1·62 servings , P = 0·005 ) and refined grains decreased by a mean of 0·33 servings ( baseline 0·82 servings , P = 0·005 ) . The daily consumption of fruits increased by a mean of 0·18 servings ( baseline 0·39 servings , P = 0·008 ) , whole grains increased by 0·38 servings ( baseline 1·44 servings , P = 0·008 ) and refined grains decreased by a mean of 0·31 servings ( baseline 0·68 servings , P = 0·004 ) . Total kilojoules and total gram weight of food selected and consumed were unchanged . Fruit ( P = 0·04 ) and vegetable ( P = 0·03 ) plate waste decreased . CONCLUSIONS A Smarter Lunchroom intervention significantly increased whole grain selection and consumption , reduced refined grain selection and consumption , increased fruit consumption , and reduced fruit and vegetable plate waste . Nudge approaches may be effective for improving the food selection and consumption habits of adolescents and young adults with intellectual and developmental disabilities IMPORTANCE Little is known about the long-term effect of a chef-enhanced menu on healthier food selection and consumption in school lunchrooms . In addition , it remains unclear if extended exposure to other strategies to promote healthier foods ( eg , choice architecture ) also improves food selection or consumption . OBJECTIVE To evaluate the short- and long-term effects of chef-enhanced meals and extended exposure to choice architecture on healthier school food selection and consumption . DESIGN , SETTING , AND PARTICIPANTS A school-based r and omized clinical trial was conducted during the 2011 - 2012 school year among 14 elementary and middle schools in 2 urban , low-income school districts ( intent-to-treat analysis ) . Included in the study were 2638 students in grade s 3 through 8 attending participating schools ( 38.4 % of eligible participants ) . INTERVENTIONS Schools were first r and omized to receive a professional chef to improve school meal palatability ( chef schools ) or to a delayed intervention ( control group ) . To assess the effect of choice architecture ( smart café ) , all schools after 3 months were then r and omized to the smart café intervention or to the control group . MAIN OUTCOMES AND MEASURES School food selection was recorded , and consumption was measured using plate waste methods . RESULTS After 3 months , vegetable selection increased in chef vs control schools ( odds ratio [ OR ] , 1.75 ; 95 % CI , 1.36 - 2.24 ) , but there was no effect on the selection of other components or on meal consumption . After long-term or extended exposure to the chef or smart café intervention , fruit selection increased in the chef ( OR , 3.08 ; 95 % CI , 2.23 - 4.25 ) , smart café ( OR , 1.45 ; 95 % CI , 1.13 - 1.87 ) , and chef plus smart café ( OR , 3.10 ; 95 % CI , 2.26 - 4.25 ) schools compared with the control schools , and consumption increased in the chef schools ( OR , 0.17 ; 95 % CI , 0.03 - 0.30 cups/d ) . Vegetable selection increased in the chef ( OR , 2.54 ; 95 % CI , 1.83 - 3.54 ) , smart café ( OR , 1.91 ; 95 % CI , 1.46 - 2.50 ) , and chef plus smart café schools ( OR , 7.38 , 95 % CI , 5.26 - 10.35 ) compared with the control schools , and consumption also increased in the chef ( OR , 0.16 ; 95 % CI , 0.09 - 0.22 cups/d ) and chef plus smart café ( OR , 0.13 ; 95 % CI , 0.05 - 0.19 cups/d ) schools ; however , the smart café intervention alone had no effect on consumption . CONCLUSIONS AND RELEVANCE Schools should consider both collaborating with chefs and using choice architecture to increase fruit and vegetable selection . Efforts to improve the taste of school foods through chef-enhanced meals should remain a priority because this was the only method that also increased consumption . This was observed only after students were repeatedly exposed to the new foods for 7 months . Therefore , schools should not ab and on healthier options if they are initially met with resistance . TRIAL REGISTRATION clinical trials.gov Identifier : NCT02309840 The object of this study was to determine whether students attending schools with self-service salad bars consume a greater amount of fruits and vegetables compared with students using preportioned servings and to evaluate the relationship between number of items offered and fruit and vegetable consumption . Two hundred ninety-four students in first through fifth grade were r and omly selected from two schools with salad bars and two with preportioned servings . Weights of fruit and vegetable items were measured pre- and postconsumption and interobserver agreement + /-1 g was > or = 95 % . Presence of a salad bar was not associated with greater fruit and vegetable consumption . Fruit and vegetable consumption was positively related to the number of fruit and vegetable items offered at salad bars ( P < .05 ) , adjusting for sex and grade . Fruit and vegetable variety was associated with elementary school-age children 's fruit and vegetable consumption when using salad bars OBJECTIVE To examine the effects of a multi-component , theory-based , 2.5-year intervention on children 's fruit and vegetable consumption , preferences , knowledge and body mass index . METHODS Four inner city elementary schools in the Northeastern United States were r and omized to an intervention ( n=149 ) or control group ( n=148 ) in 2005 . Fruit and vegetable consumption during school lunch ( measured by plate waste ) , preferences , and knowledge , as well as body mass index , were assessed five times across 3.5 years ( pre
Output:
| Fruits and vegetables were the most research ed dietary component on the lunch tray and yielded the greatest amount of waste across studies . |
MS210912 | ***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 test the hypothesis that nonselective plasma adsorption by a hydrophobic resin ( coupled plasmafiltration and adsorption ) could improve hemodynamics and restore leukocyte responsiveness in patients with septic shock . Design Prospect i ve , pilot , crossover clinical trial . Setting General intensive care unit in a teaching hospital . SubjectsTen patients with hyperdynamic septic shock . Interventions Patients were r and omly allocated to 10 hrs of either coupled plasma filtration adsorption plus hemodialysis ( treatment A ) or continuous venovenous hemodiafiltration ( treatment B ) in r and om order . We measured the change in mean arterial pressure , norepinephrine requirements , and leukocyte tumor necrosis factor-&agr ; ( TNF-&agr ; ) production ( both spontaneous and lipopolysaccharide-stimulated ) after 10 hrs of each treatment . We also tested TNF-&agr ; production from normal human adherent monocytes incubated with patients ’ plasma obtained before and after the resin , both with or without incubation with an anti-interleukin-10 monoclonal antibody . Results Mean arterial pressure increased after 10 hr by 11.8 mm Hg with treatment A and by 5.5 mm Hg with treatment B ( p = .001 ) . There was an average decrease of norepinephrine requirement of 0.08 & mgr;g/kg/min with treatment A and 0.0049 & mgr;g/kg/min with treatment B ( p = .003 ) . All patients but one survived . Spontaneous and lipopolysaccharide-induced TNF-&agr ; production from patients ’ whole blood increased over time with treatment A. This increase was more marked in blood drawn after the device ( plasmafiltrate-sorbent plus hemodialyzer ) ( p = .009 ) . Preresin plasma suppressed lipopolysaccharide-stimulated production of TNF-&agr ; by 1 × 106 cultured adherent monocytes from healthy donors . This suppressive effect was significantly reduced after passage of plasma through the resin ( p = .019 ) and after incubation with anti-interleukin-10 monoclonal antibodies ( p = .028 ) . Conclusions In patients with septic shock , coupled plasmafiltration-adsorption combined with hemodialysis was associated with improved hemodynamics compared with continuous venovenous hemodiafiltration . This result might be related to its ability to restore leukocyte responsiveness to lipopolysaccharide . These findings suggest a potential role for blood purification in the treatment of septic shock In a prospect i ve non-r and omized trial , 59 patients with sepsis ( n = 43 ) and SIRS ( n = 16 ) were treated on a surgical intensive care unit . In 22 patients plasmapheresis in combination with continuous venovenous hemofiltration ( CVVHF ) was administered . Lethality was 56 % in the sepsis group ; in the therapy group lethality was significantly lower in patients with plasmapheresis , even though in this population the organic failure rate was higher . Finally the dependency of lethality and age was similar in both groups . Lethality at 22 % in the plasmapheresis group with double organ failure was significantly lower ( P > 0.01 ) than in controls . Reduction of lethality seemed to be as high as 18 % in patients with sepsis , while patients with SIRS did not profit from the additional therapy . A prospect i ve r and omized trial in sepsis and double organic failure should be projected Aim : The aim of this study was to observe the effects of coupled plasma filtration adsorption ( CPFA ) on septic patients with multiple organ dysfunction syndrome ( MODS ) . Methods : A total of 14 patients were r and omly divided into two groups , and , respectively , received 10 h of CPFA or high-volume hemofiltration ( HVHF ) . The mean arterial pressure ( MAP ) , electrolytes and acid – base balance , the sequential organ failure assessment ( SOFA ) score , and the acute physiology and chronic health evaluation II ( APACHE II ) score were analyzed . Serum levels of high-mobility group box-1 ( HMGB-1 ) protein , tumor necrosis factor-α ( TNF-α ) , and intercellular adhesion molecule-1 ( ICAM-1 ) were also measured by enzyme-linked immunosorbent assay . Results : After CPFA and HVHF , temporary reduction in blood urea nitrogen and serum creatinine , electrolytes and acid – base metabolism balance were well maintained . Both the SOFA and the APACHE II scores were markedly reduced after CPFA ( p < 0.01 ) , while only the SOFA score was significantly decreased after HVHF ( p < 0.05 ) . After 10-h treatment with CPFA , the MAP and oxygen index ( PaO2/FiO2 ) were significantly higher than those at 0 h. Furthermore , the serum levels of HMGB-1 , ICAM-1 , and TNF-α decreased after 10 h of CPFA ( p < 0.05 ) , while the serum levels of HMGB-1 declined at 5 h of HVHF , but rebounded at 10 h , and the serum levels of TNF-α and ICAM-1 were no significant change after treatment with HVHF . Conclusions : The study indicated that CPFA could be superior to HVHF in improving the clinical manifestations and eliminating inflammatory mediators , which had implication s in the optimal treatment of septic patients with MODS Objective The objective was to examine the effect of repeated applications of coupled plasmafiltration-adsorption on the hemodynamic response in septic shock patients hospitalized in intensive care units ( ICUs ) . Design Prospect i ve , intention-to-treat . Setting General ICU of a tertiary care , non-teaching , 400-bed , city hospital . Patients and participants Twelve consecutive mechanically ventilated septic shock patients , with or without concomitant acute renal failure (ARF).InterventionA median of 10 consecutive sessions ( prescribed treatment time : 10 h/session ; delivered duration : 8.43±1.37 h/min ) of coupled plasmafiltration-adsorption for each patient . Measurements and results Mean arterial pressure ( 77.2±12.5 [ CI 95 % ; 74.5–79.8 ] vs. 83.3±14.1 [ CI 95 % ; 80.3–86.3 ] mm Hg ; [ p<0.001 ] ) , cardiac index ( 4.03±0.89 [ CI 95 % ; 3.83–4.22 ] vs. 3.46±0.82 [ CI 95 % ; 3.28–3.64 ] L/m2/min ; [ p<0.001 ] ) , systemic vascular resistance index ( 1,388±496 [ CI 95 % ; 1,278–1,497 ] vs. 1,753±516 [ CI 95 % ; 1,639–1,867 ] dynes × s/cm5 ; [ p<0.001 ] ) , PO2/FIO2 ratio ( 204±87 [ CI 95 % ; 185–223 ] vs. 238±82 [ CI 95 % ; 220–256 ] ; [ p<0.001 ] ) , significantly improved during 100 global treatments ( pre- vs. post-treatment values ) . Intra-thoracic blood volume and extra-vascular lung water did not change across treatments . Vasopressor requirement was reduced : norepinephrine decrease from an infusion rate of 0.13±0.07 ( CI 95 % ; 0.06–0.16 ) to 0 γ/kg/min after a mean of 5.3±2.7 sessions . C reactive protein ( CRP ) significantly decreased ( from 29.3±7.3 vs. 7.9±4.8 ; p<0.0001 ) during treatment . Survival was 90 % at day 28 and 70 % at day 90 . Conclusion Coupled plasmafiltration-adsorption was a feasible and safe extracorporeal treatment and exerted a remarkable improvement in the hemodynamics , the pulmonary function , and the outcome in septic shock patients with or without concomitant ARF ABSTRACT Early compliance with the sepsis resuscitation bundle has been suggested to reduce mortality . However , few data are available about the impact of late compliance with the bundle on outcomes . The aim of this study was to assess whether the completion of the resuscitation bundle within the first 6 h after admission to the intensive care unit ( ICU ) , but beyond the specific time limit of the various bundle interventions , is related to an improvement in survival . This prospect i ve , cohort study included 753 patients recruited from September 2005 until August 2010 with severe sepsis/septic shock in the three medical-surgical ICUs of a tertiary academic medical center . We assessed the compliance with the different tasks included in the resuscitation bundle . Furthermore , we ascertained within the first 6 h after ICU admission the compliance with those tasks not carried out within their specific time limits ; we have termed this variable “ bundle improvement in the ICU . ” Septic shock was present in 88.1 % . The overall in-hospital mortality was 31.6 % . In 51.5 % , there was bundle improvement in the ICU ; this variable was associated with a lower risk of mortality ( adjusted hazard ratio , 0.52 [ 95 % confidence interval , 0.34–0.78 ] ) . That association was observed only when the time from severe sepsis onset to ICU admission was 6 h or less . Importantly , similar results were found after excluding all patients with severe sepsis ( rapid responders ) and those with refractory shock ( nonresponders ) . The task with highest improvement was the achievement of central venous oxygen saturation 70 % or greater in 39 % of patients . Compliance with the resuscitation bundle even beyond the recommended time is associated with improvement in survival in patients with severe sepsis/septic shock Despite the use of potent antibiotics and intensive supportive care , the mortality among patients with sepsis and Gram-negative bacteremia remains high . In recent years , endotoxin adsorption therapy ( PMX-DHP , polymyxin-direct hemoperfusion ) has been widely used in Japan to remove endotoxin , a causative agent of sepsis . In septic patients whose clinical condition may change at any moment , the decision of when to perform blood purification in addition to conventional intensive care is a critical factor in the therapeutic strategy and prognosis . In the present study , we investigated the effect over time of PMX-DHP in sepsis . The subjects were 16 patients with systemic inflammatory response syndrome ( SIRS ) who required surgical treatment including a surgical operation and drainage . The following six parameters were compared between the first and second PMX-DHP : mean blood pressure and time-restricted urine at four time points - at baseline and at 6 , 24 and 72 h after PMX-DHP ; and white blood cell count , platelet count , base excess and Septic Severity Score ( SSS ) at 24 and 72 h after PMX-DHP . Mean blood pressure improved over time up to 24 h after both the first and second PMX-DHP . Time-restricted urine volume improved only at 6 h after the first PMX-DHP . White blood cell count improved over time up to 24 h after both the first and second PMX-DHP . The SSS improved at all time points studied except for 3 days after the second PMX-DHP . We conclude that PMX-DHP is expected to have important implication s in terms of ( i ) correction of clinical conditions ( by severity assessment ) ; ( ii ) improvement of hemodynamics ; ( iii ) possible anti-inflammatory effect ; and ( iv ) possible improvement of oxygen metabolism in tissues Severe sepsis is known to cause multiple organ failure , including renal dysfunction . During sepsis , endotoxin targets the renal proximal tubular cells , the function of which can be evaluated on the basis of urinary N-acetyl-&bgr;-glucosaminidase ( NAG ) . We investigated whether urinary NAG activity is altered in patients with severe sepsis and whether treatment with polymyxin B immobilized fibers ( PMX-F ) affects this activity . Subjects of this study were 120 patients with severe sepsis and 60 healthy volunteers matched for age and gender . Patients were r and omly assigned to one of two treatments : PMX-F treatment ( n = 70 ) or conventional treatment ( n = 50 ) . The plasma endotoxin level was significantly reduced , from 34.6 ± 10.2 to 6.8 ± 2.4 pg/ml ( p < 0.01 ) in patients treated with PMX-F , and the urinary NAG/creatinine ratio was reduced from 46.5 ± 26.8 U/gm to 18.6 ± 13.6 U/gm ( p < 0.01 ) . The plasma endotoxin level and urinary NAG/creatinine ratio were unchanged in patients who received conventional treatment . The increased urinary NAG/creatinine ratio in patients with severe sepsis may reflect proximal tubular dysfunction . PMX-F is effective in reducing proximal tubular dysfunction , in part owing to reduced plasma endotoxin levels Many kinds of blood purifying technologies have been applied to the treatment of critically ill patients since 1979 when plasma exchange with hollow-fiber membran
Output:
| Evidence for CPFA in severe sepsis is sparse , of poor quality and further research is required , however , this meta- analysis noted improvements in survival rates of those patients treated with CPFA |
MS210913 | ***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: Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items 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 Patients undergoing surgery are prone to develop pressure ulcers during surgery . The aim of this study was to identify pressure ulcer risk indicators in patients undergoing surgery which lasted more than four hours . A prospect i ve follow-up study was conducted in 208 patients . Data on presence or absence of pressure ulcers and risk indicators were collected preoperatively , during surgery , and postoperatively . The results show that of the many indicators recorded , the only predictor of pressure ulcers was length of surgery . Because it is not possible to influence the length of the surgery , prevention should primarily be aim ed at decreasing pressure and shearing forces during surgery The purpose of this prospect i ve study was to determine the incidence of pressure ulcers and to examine factors related to pressure ulcer development in patients in an acute care setting . Adult medical and surgical patients who were free of pressure ulcers at admission were assessed within 36 hours of admission and then three times per week for 2 weeks or until discharge . Instruments included a demographic data form , a skin assessment form , and the Braden Scale for Predicting Pressure Sore Risk . Most subjects had 46 assessment s completed . The sample consisted of 149 subjects , with a pressure ulcer incidence rate of 13.4 % ( n = 20 ) . Subjects who acquired pressure ulcers had lower hemoglobin levels ( t = 2.17 , p = 0.03 ) , spent more time in bed ( t = 3.90 , p = 0.0001 ) , and spent less time in a chair ( t = 3.2 , p = 0.002 ) than those who did not acquire pressure ulcers . A stepwise logistic regression analysis was used to calculate risk of pressure ulcer development . In the final model , hemoglobin level and hours spent in bed continued to be predictors of pressure ulcer development ( chi 2 = 9.306 , df = 2 , p = 0.0095 ) . All 20 subjects who acquired pressure ulcers were further categorized into groups with stage I ( n = 12 ) or stage II ( n = 8) ulcers . Patients with stage I pressure ulcers were primarily receiving post-surgical care ( 67 % ) , whereas patients who acquired stage II ulcers had medical conditions that affected tissue perfusion , such as respiratory diseases ( 50 % ) and diabetes mellitus ( 12 % ) DESIGN Nonexperimental-Descriptive . SAMPLE The inclusion criteria were trauma patients , ages 15 and older , who were hospitalized for > 2 days , and who did not have preexisting skin breakdown . A total of 148 consecutive trauma patients admitted to the study institution meeting the inclusion criteria were prospect ively enrolled . METHODS Patients were assessed every 3 days for skin breakdown . Information on the patient 's bed type , therapies , medical devices , and nutrition was collected . The Braden Scale for predicting pressure ulcer risk was completed at each assessment . FINDINGS Of the 148 patients enrolled , 30 developed at least one area of skin breakdown for a prevalence of 20.3 % in patients hospitalized more than 2 days . The most common cause of breakdown was positional pressure ( 47.4 % ) . Cervical collars were the second leading cause at 23.7 % , followed by tracheostomy/endotracheal tubes at 10.5 % . The mobility subscale of the Braden Pressure Ulcer Risk Assessment tool was significantly predictive of skin breakdown ( p < .001 ) . IMPLICATION S FOR NURSING RESEARCH Skin breakdown is a significant problem in trauma patients who are hospitalized for more
Output:
| Risk factors emerging most frequently as independent predictors of pressure ulcer development included three primary domains of mobility/activity , perfusion ( including diabetes ) and skin/pressure ulcer status .
Skin moisture , age , haematological measures , nutrition and general health status are also important , but did not emerge as frequently as the three main domains .
There is limited evidence that either race or gender is important .
Overall there is no single factor which can explain pressure ulcer risk , rather a complex interplay of factors which increase the probability of pressure ulcer development . |
MS210914 | ***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: INTRODUCTION Caffeine enhances performance of single bouts of endurance exercise , but its effects on repeated bouts typical of those in high-intensity team sports are unclear . PURPOSE To investigate effects of caffeine in a performance test simulating physical and skill dem and s of a rugby union game . METHODS The study was a double-blind , r and omized , crossover design in which nine competitive male rugby players ingested either caffeine ( 6 mg.kg(-1 ) body mass ) or placebo ( dextrose ) 70 min before performing a rugby test . Each test consisted of seven circuits in each of two 40-min halves with a 10-min half-time rest . Each circuit included stations for measurement of sprint time ( two straight-line and three agility sprints ) , power generation in two consecutive drives , and accuracy for passing balls rapidly . Interstitial fluid was sample d transdermally by electrosonophoresis before ingestion of caffeine or placebo and then before testing , at half-time , and immediately after testing ; sample s were assayed chromatographically for caffeine and epinephrine concentrations . RESULTS The effects of caffeine on mean performance ( + /-90 % confidence limits ) over all 14 circuits were : sprint speeds , 0.5 % ( + /-1.7 % ) through 2.9 % ( + /-1.3 % ) ; first-drive power , 5.0 % ( + /-2.5 % ) ; second-drive power , -1.2 % ( + /-6.8 % ) ; and passing accuracy , 9.6 % ( + /-6.1 % ) . The enhancements were mediated partly through a reduction of fatigue that developed throughout the test and partly by enhanced performance for some measures from the first circuit . Caffeine produced a 51 % ( + /-11 % ) increase in mean epinephrine concentration ; correlations between individual changes in epinephrine concentration and changes in performance were mostly unclear , but there were some strong positive correlations with sprint speeds and a strong negative correlation with passing accuracy . CONCLUSION Caffeine is likely to produce substantial enhancement of several aspects of high-intensity team-sport performance PURPOSE This study was design ed to examine the effect of carbohydrate ( CHO ) feedings on physical and central nervous system ( CNS ) function during intermittent high-intensity exercise with physical dem and s similar to those of team sports such as basketball . METHODS Twenty active men ( N = 10 ) and women ( N = 10 ) , with experience competing in team sports , performed three practice sessions before two experimental trials during which they were fed either a 6 % CHO solution or a flavored placebo ( PBO ) . Experimental trials consisted of four 15-min quarters of shuttle running with variable intensities ranging from walking ( 30 % VO(2max ) ) , to running ( 120 % VO(2max ) ) , to maximal sprinting , and 40 jumps at a target hanging at 80 % of their maximum vertical jump height . Subjects received 5 mL.kg(-1 ) of fluid before exercise and 3 mL.kg(-1 ) after exercise , in addition to 3 mL.kg(-1 ) over a 5-min span after the first and third quarters , and 8 mL.kg(-1 ) during a 20-min halftime . During each break , the subjects performed a battery of tests measuring peripheral and CNS function , including 20-m sprints , a 60-s maximal jumping test , internal and external mood evaluation , cognitive function , force sensation , tests of motor skills , and target-jumping accuracy . RESULTS Compared with PBO , CHO feedings during exercise result ed in faster 20-m sprint times and higher average jump height in the fourth quarter ( P < 0.05 ) . CHO feedings also reduced force sensation , enhanced motor skills , and improved mood late in exercise versus PBO ( P < 0.05 ) . CONCLUSION These results suggest that CHO feedings during intermittent high-intensity exercise similar to that of team sports benefited both peripheral and CNS function late in exercise compared with a flavored placebo BACKGROUND AND PURPOSE Prolonged wakefulness impairs sustained vigilant attention , measured with the psychomotor vigilance task ( PVT ) , and induces a compensatory increase in sleep intensity in recovery sleep , quantified by slow‐wave activity ( SWA ) in the sleep electroencephalogram ( EEG ) . These effects of sleep deprivation are counteracted by the adenosine receptor antagonist caffeine , implying involvement of the adenosine neuromodulator/receptor system . To examine a role for adenosine A2A receptors , we investigated whether variation of the A2A receptor gene ( ADORA2A ) modified effects of caffeine on PVT and SWA after sleep deprivation To examine the effects of aerobic interval training on the decline in short-passing ability caused by a short bout of high-intensity intermittent activities . For this r and omized controlled trial , 26 junior soccer players ( mean age , 17.8 + /- 0.6 years ; mean height , 178 + /- 5 cm ; mean body mass , 74.5 + /- 6.9 kg ) were recruited . After baseline measurements , subjects were r and omly allocated to 1 of 2 groups : the control group ( CG ) or the aerobic interval training group ( ITG ) . The ITG completed 4 weeks of high-intensity aerobic training , consisting of 4 bouts of running for 4 min at 90%-95 % of maximal heart rate , with 3 min of active recovery between sets , in addition to normal training . Maximum oxygen uptake , Yo-Yo Intermittent Recovery Test level 1 ( YYIRT ) , and short-passing ability ( measured using the Loughborough Soccer Passing Test ( LSPT ) ) were measured before and after a 5 min high-intensity simulation ( HIS ) , reproducing the most intense phase of a match . The ITG ( n = 11 ) , but not the CG ( n = 10 ) , showed a significant 12 % and 4 % increase in YYIRT and maximal oxygen consumption after training , respectively , and reduced the worsening in LSPT penalty time after the HIS ( p < 0.05 ) . The relative exercise intensity during HIS decreased in the ITG only ( p < 0.01 ) . Our results demonstrated that junior soccer players may benefit from aerobic training to attenuate the decline in short-passing ability caused by a short bout of intermittent activities completed at the same pretraining workload PURPOSE This study was design ed to examine the effects of carbohydrate-electrolyte ingestion on physical and mental function associated with the performance of intermittent high-intensity ( IHI ) exercise similar to many common competitive sporting events . METHODS Physically active men ( N = 5 ) and women ( N = 5 ) , experienced in competitive soccer or basketball , completed three practice sessions and two experimental trials of an IHI shuttle running protocol design ed to closely stimulate the dem and s of an actual competitive sporting event such as basketball . The experimental trials consisted of four 15-min quarters ( QTR ) of intermittent shuttle running at various percentages of .VO(2max ) ( walking , jogging , running , sprinting and jumping ) , separated by a 20-min halftime rest period ( HALF ) and followed by a shuttle run to fatigue . Various tests of physical and mental function ( shuttle run to fatigue , 20-m maximal sprint , 10-repetition maximal vertical jumping , whole body motor skill test ( MS-Test ) , profile of mood states ( POMS ) , and Stroop Color-Word Test ) were performed throughout the experimental trial . Carbohydrate-electrolyte ( CHO ) or placebo ( P ) drinks were consumed before exercise ( 5 mL.kg(-1 ) ; 6 % solution ) and at halftime ( 5 mL.kg(-1 ) ; 18 % solution ) . Smaller volumes ( 3 mL.kg(-1 ) ; 6 % solution ) were given after QTR-1 , HALF , QTR-3 , and QTR-4 . RESULTS CHO ingestion result ed in a 37 % longer run time to fatigue and faster 20-m sprint time during QTR-4 ( P < 0.05 ) . MS-Test performance was also improved during the latter stages of exercise along with self-reported perceptions of fatigue ( subscale of POMS ) ( P < 0.05 ) in CHO versus P. CONCLUSION These results suggest a beneficial role of carbohydrate-electrolyte ingestion on physical and mental function during intermittent exercise similar to that of many competitive team sports This study examined the effects of ingesting a glucose-polymer ( GP ) solution on the motor skill proficiencies of association football ( soccer ) players from two teams playing during two matches in a cool environment . Fifteen minutes before each match and at halftime , players from both teams ingested 5 ml/kg of either placebo or a 6.9 % GP solution . GP ingestion did not improve tackling , heading , dribbling , or shooting ability . On the contrary , the mean of successful tackles was lower with GP ingestion than with placebo . The success rate for heading , dribbling , and shooting also tended to be lower in the GP than in the placebo condition . In contrast , success in passing and ball control was similar in the two conditions . Improvements in passing and ball control may have been related to a decrease in the intensity of play in the second half of the game . These data indicate that there are no measurable benefits of GP ingestion for the motor skill proficiencies of soccer players during games played in a cool environment 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 The effects of high-intensity , short- duration , re-warm-ups on team-sport-related performance were investigated . In a r and omised , cross-over study , participants performed 2 × 26-min periods of an intermittent activity protocol ( IAP ) on a non-motorized treadmill , interspersed by 15-min of passive recovery ( CON ) ; 3-min small-sided game ( SSG ) ; or a 5RM leg-press . Measures included counter-movement jump , repeated-sprint , the Loughborough soccer passing test ( LSPT ) , blood lactate concentration , heart-rate , and perceptual measures . Data were analyzed using effect size ( 90 % confidence intervals ) , and percentage change ; determining magnitudes of effects . A 5RM re-warm-up improved flight-time to contraction-time ratio when compared to SSG ( 9.8 % , ES ; 0.5±0.3 ) and CON ( ES : 9.4 % , 0.7±0.5 ) re-warm-ups , remaining higher following the second IAP ( 8.8 % , ES ; 0.5±0.3 and 10.2 % , ES ; 0.6±0.6 , respectively ) . Relative-maximum rate-of-force development was greater in the 5RM condition following the second IAP compared to SSG ( 29.3 % , ES ; 0.7±0.5 ) and CON ( 16.2 % , ES ; 0.6±0.6 ) . Repeated-sprint ability during the second IAP improved in the 5RM re-warm-up ; peak velocity , mean velocity , and acceleration were 4 , 3 , and 18 % greater , respectively . Within groups , the SSG re-warm-up improved LSPT performance post-intervention ; 6.4 % ( ES : 0.6±0.8 ) and following the second IAP 6.2 % ( ES : 0.6±0.6 ) , compared to pre-intervention . A 5RM leg-press re-warm-up improved physical performance , while a SSG re-warm-up enhanced skill execution following st and ardized intermittent exercise OBJECTIVES To examine the effect of a high carbohydrate meal on serum caffeine concentration following caffeine intake . DESIGN R and omised , double-blind , crossover . METHODS Fourteen healthy males r and omly completed 4 trials , each separated by 5 days . Participants either remained fasted ( on 2 occasions ) or ingested a high carbohydrate meal ( 2.0gkg(-1 ) carbo
Output:
| Conclusions The findings from this systematic review suggest that nutritional interventions , which provide carbohydrate , caffeine and fluid , have potential to preserve skills performed under conditions that induce soccer-specific fatigue .
The weight of current evidence supports the consumption of carbohydrate , but is less conclusive with respect to caffeine and fluid provision . |
MS210915 | ***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 — Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist ( TOPCAT ) patients with heart failure and preserved left ventricular ejection fraction assigned to spironolactone did not achieve a significant reduction in the primary composite outcome ( time to cardiovascular death , aborted cardiac arrest , or hospitalization for management of heart failure ) compared with patients receiving placebo . In a post hoc analysis , an ≈4-fold difference was identified in this composite event rate between the 1678 patients r and omized from Russia and Georgia compared with the 1767 enrolled from the United States , Canada , Brazil , and Argentina ( the Americas ) . Methods and Results — To better underst and this regional difference in clinical outcomes , demographic characteristics of these population s and their responses to spironolactone were explored . Patients from Russia/Georgia were younger , had less atrial fibrillation and diabetes mellitus , but were more likely to have had prior myocardial infa rct ion or a hospitalization for heart failure . Russia/Georgia patients also had lower left ventricular ejection fraction and creatinine but higher diastolic blood pressure ( all P<0.001 ) . Hyperkalemia and doubling of creatinine were more likely and hypokalemia was less likely in patients receiving spironolactone in the Americas with no significant treatment effects in Russia/Georgia . All clinical event rates were markedly lower in Russia/Georgia , and there was no detectable impact of spironolactone on any outcomes . In contrast , in the Americas , the rates of the primary outcome , cardiovascular death , and hospitalization for heart failure were significantly reduced by spironolactone . Conclusions — This post hoc analysis demonstrated greater potassium and creatinine changes and possible clinical benefits with spironolactone in patients with heart failure and preserved ejection fraction from the Americas . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00094302 Background —The Minnesota Living with Heart Failure Question naire ( MLHFQ ) was used in a large , multinational , r and omized , placebo-controlled trial to measure adverse effects of heart failure with preserved ejection fraction ( HF-PEF ) on patients ' lives and the effects of irbesartan . Methods and Results — Patients with symptomatic HF-PEF were r and omly assigned to irbesartan ( up to 300 mg daily ) or placebo . The MLHFQ was administered at baseline ( n=3605 ) , month 6 ( n=3137 ) , month 14 ( n=2904 ) , and the end of study ( median , 56 months , n=2205 ) . Baseline MLHFQ scores of 43±21 indicated that HF-PEF had a substantial adverse effects . Estimated retest reliability was 0.80 . Baseline MLHFQ scores were associated with other measures of the severity of heart failure including symptoms , signs of congestion , cardiac structure , and time to hospitalizations or deaths attributed to heart failure . Slight improvement in shortness of breath or fatigue was associated with significant improvement in MLHFQ scores ( −5.9 and −5.0 , P<0.0001 ) . Compared with placebo , further improvement in MLHFQ scores was not observed with irbesartan after 6 months ( mean adjusted difference , 0.4 ; 95 % confidence interval , −0.8 to 1.7 ) , 14 months ( 0.5 ; 95 % confidence interval , −0.9 to 1.8 ) , or the end of study ( 2.0 ; 95 % confidence interval , −4.1 to 0.01 ) . Conclusions —The MLHFQ scores are a reliable , valid , and sensitive measure of the adverse impact of HF-PEF on patients ' lives . Irbesartan did not substantially improve MLHFQ scores during a long period of follow-up . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00095238 Background —Specific treatments targeting the pathophysiology of hypertensive heart disease are lacking . As aldosterone has been implicated in the genesis of myocardial fibrosis , hypertrophy , and dysfunction , we sought to determine the effects of aldosterone antagonism on myocardial function in hypertensive patients with suspected diastolic heart failure by using sensitive quantitative echocardiographic techniques in a r and omized , double-blinded , placebo-controlled study . Methods and Results —Thirty medically treated ambulatory hypertensive patients ( 19 women , age 62±6 years ) with exertional dyspnea , ejection fraction > 50 % , and diastolic dysfunction ( E/A < 1 , E deceleration time > 250m/sec ) and without ischemia were r and omized to spironolactone 25 mg/d or placebo for 6 months . Patients were overweight ( 31±5 kg/m2 ) with reduced treadmill exercise capacity ( 6.7±2.1 METS ) . Long-axis strain rate ( SR ) , peak systolic strain , and cyclic variation of integrated backscatter ( CVIB ) were averaged from 6 walls in 3 st and ard apical views . Mean 24-hour ambulatory blood pressure at baseline ( 133±17/80±7 mm Hg ) did not change in either group . Values for SR , peak systolic strain , and CVIB were similar between groups at baseline and remained unchanged with placebo . Spironolactone therapy was associated with increases in SR ( baseline : −1.57±0.46 s−1 versus 6-months : −1.91±0.36 s−1 , P<0.01 ) , peak systolic strain ( −20.3±5.0 % versus −26.9±4.3 % , P<0.001 ) , and CVIB ( 7.4±1.7dB versus 8.6±1.7 dB , P=0.08 ) . Each parameter was significantly greater in the spironolactone group compared with placebo at 6 months ( P=0.05 , P=0.02 , and P=0.02 , respectively ) , and the increases remained significant after adjusting for baseline differences . The increase in strain was independent of changes in blood pressure with intervention . The spironolactone group also exhibited reduction in posterior wall thickness ( P=0.04 ) and a trend to reduced left atrial area ( P=0.09 ) . Conclusions —Aldosterone antagonism improves myocardial function in hypertensive heart disease Background — Heart failure with preserved ejection fraction ( HFPEF ) is a common and increasing public health problem . Myocardial fibrosis is a key pathological feature of HFPEF . Peripheral collagen markers may reflect this excess fibrosis ; however , the relation of these markers to prognosis in patients with HFPEF has not as yet been determined . Methods and Results — This sub study of the Irbesartan in Heart Failure With Preserved Systolic Function ( I-PRESERVE ) trial measured plasma levels of procollagen type I amino-terminal peptide , procollagen type III amino-terminal peptide , and osteopontin in 334 patients with HFPEF . Measurements were performed at baseline and 6 months after r and omization to placebo or irbesartan 300 mg/day . The relation of baseline collagen markers to the I-PRESERVE primary end point ( all-cause death and hospitalization for prespecified cardiovascular causes ) was evaluated by single and multivariable analysis . Similar evaluations were performed for all-cause death alone as well as heart failure events ( death or hospitalization because of heart failure ) . Increased plasma levels of collagen markers at baseline were associated with increased frequency of the study primary end point for all collagen markers . For each 10-&mgr;g/L increase in procollagen type I amino-terminal peptide , the hazard ratio ( HR ) for the primary end point was 1.09 ( 95 % CI , 1.052 to 1.13 ; P<0.0001 ) ; for each 10-&mgr;g/L increase in procollagen type III amino-terminal peptide procollagen type I amino-terminal peptide , the HR was 2.47 ( 95 % CI , 0.97 to 6.33 ; P=0.059 ) ; and for each 10-nmol/L increase in osteopontin , the HR was 1.084 ( 95 % CI , 1.026 to 1.15 ; P=0.004 ) . No variable remained significant as an independent predictor when introduced into a multivariable model . Both treatment groups tended to reduce collagen markers , with the reduction significantly greater for placebo versus irbesartan for procollagen type III amino-terminal peptide only ( P=0.0185 ) . Conclusions — Increased peripheral collagen turnover markers were not independently associated with increased mortality and cardiovascular hospitalization in an HFPEF population on multivariable analysis but were associated on single-variable analysis . These findings provide some support to the hypothesis that pathological fibrosis in the heart , and possibly the peripheral vasculature , may be contributory to adverse clinical outcomes in patients with HFPEF . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00095238 BACKGROUND Angiotensin-converting-enzyme ( ACE ) inhibitors improve outcome of patients with chronic heart failure ( CHF ) . A substantial proportion of patients , however , experience no benefit from ACE inhibitors because of previous intolerance . We aim ed to find out whether c and esartan , an angiotensin-receptor blocker , could improve outcome in such patients not taking an ACE inhibitor . METHODS Between March , 1999 , and March , 2001 , we enrolled 2028 patients with symptomatic heart failure and left-ventricular ejection fraction 40 % or less who were not receiving ACE inhibitors because of previous intolerance . Patients were r and omly assigned c and esartan ( target dose 32 mg once daily ) or matching placebo . The primary outcome of the study was the composite of cardiovascular death or hospital admission for CHF . Analysis was by intention to treat . FINDINGS The most common manifestation of ACE-inhibitor intolerance was cough ( 72 % ) , followed by symptomatic hypotension ( 13 % ) and renal dysfunction ( 12 % ) . During a median follow-up of 33.7 months , 334 ( 33 % ) of 1013 patients in the c and esartan group and 406 ( 40 % ) of 1015 in the placebo group had cardiovascular death or hospital admission for CHF ( unadjusted hazard ratio 0.77 [ 95 % CI 0.67 - 0.89 ] , p=0.0004 ; covariate adjusted 0.70 [ 0.60 - 0.81 ] , p<0.0001 ) . Each component of the primary outcome was reduced , as was the total number of hospital admissions for CHF . Study -drug discontinuation rates were similar in the c and esartan ( 30 % ) and placebo ( 29 % ) groups . INTERPRETATION C and esartan was generally well tolerated and reduced cardiovascular mortality and morbidity in patients with symptomatic chronic heart failure and intolerance to ACE inhibitors OBJECTIVES The aims of this study were to explore the relationship of baseline levels of natriuretic peptides ( NPs ) with outcomes and to test for an interaction between baseline levels of NPs and the effects spironolactone . BACKGROUND Plasma NPs are considered to be helpful in the diagnosis of heart failure ( HF ) with preserved ejection fraction ( HFpEF ) , and elevated levels are associated with adverse outcomes . Levels of NPs higher than certain cutoffs are often used as inclusion criteria in clinical trials of HFpEF to increase the likelihood that patients have HF and to select patients at higher risk for events . Whether treatments have a differential effect on outcomes across the spectrum of NP levels is unclear . METHODS The TOPCAT ( Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial ) trial r and omized patients with HFpEF and either prior hospitalization for HF or elevated natriuretic peptide levels ( B-type NP [ BNP ] ≥100 pg/ml or N-terminal proBNP ≥360 pg/ml ) to spironolactone or placebo . Baseline BNP ( n = 430 ) or N-terminal proBNP ( n = 257 ) levels were available in 687 patients enrolled from the Americas in the elevated-NP stratum of TOPCAT . RESULTS Higher levels of NPs were independently associated with an increased risk for TOPCAT 's primary endpoint of cardiovascular mortality , aborted cardiac arrest , or hospitalization for HF when analyzed either continuously or grouped by terciles , adjusting for region of enrollment , age , sex , atrial fibrillation , diabetes , renal function , body mass index , and heart rate . There was a significant interaction between the effect of spironolactone and baseline NP terciles for the primary outcome ( p = 0.017 ) , with greater benefit of the drug in the lower compared with higher NP terciles . CONCLUSIONS Similar to the effects of irbesartan in the I-PRESERVE ( Irbesartan in Heart Failure With Preserved Ejection Fraction ) trial , a greater benefit of spironolactone was observed in the group with lower levels of NPs and overall risk in TOPCAT . Elevated
Output:
| MRA treatment reduced heart failure hospitalisation ( 11 % of participants in the intervention arm versus 14 % in the control arm ; RR 0.82 ; 95 % CI 0.69 to 0.98 ; NNTB 41 ; 3714 participants ; 3 studies ; moderate- quality evidence ) however , little or no effect on all-cause and cardiovascular mortality and quality of life measures was observed .
The evidence suggested that ACEI treatment likely has little or no effect on cardiovascular mortality , all-cause mortality , heart failure hospitalisation , or quality of life .
There is evidence that MRA treatment reduces heart failure hospitalisation in heart failure with preserverd ejection fraction , however the effects on mortality related outcomes and quality of life remain unclear . |
MS210916 | ***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 Previous studies found that medication errors result from lack of sufficient information during the prescribing step . Therefore , it is proposed that having a pharmacist available when patients are evaluated during the rounding process may reduce the likelihood of preventable adverse drug events ( ADEs ) . The objectives of this study were to evaluate the impact of having a pharmacist participate with a physician rounding team on preventable ADEs in general medicine units and to document pharmacist interventions made during the rounding process . METHODS A single-blind , st and ard care-controlled study design was used to compare patients receiving care from a rounding team including a pharmacist with patients receiving st and ard care ( no pharmacist on rounding team ) . Patients admitted to and discharged from the same general medicine unit were included in the study . The main outcome measure of this study was preventable ADEs . Patient records were r and omly selected and evaluated by a blinded process involving independent senior pharmacist specialists and a senior staff physician . Interventions made by the pharmacists in the treatment group were documented . RESULTS The rate of preventable ADEs was reduced by 78 % , from 26.5 per 1000 hospital days to 5.7 per 1000 hospital days . There were 150 documented interventions recommended during the rounding process , 147 of which were accepted by the team . The most common interventions were ( 1 ) dosing-related changes and ( 2 ) recommendations to add a drug to therapy . CONCLUSION Pharmacist participation with the medical rounding team on a general medicine unit contributes to a significant reduction in preventable ADEs Objective Heart failure patients are regularly admitted to hospital and frequently use multiple medication . Besides intentional changes in pharmacotherapy , unintentional changes may occur during hospitalisation . The aim of this study was to investigate the effect of a clinical pharmacist discharge service on medication discrepancies and prescription errors in patients with heart failure . Setting A general teaching hospital in Tilburg , the Netherl and s. Method An open r and omized intervention study was performed comparing an intervention group , with a control group receiving regular care by doctors and nurses . The clinical pharmacist discharge service consisted of review of discharge medication , communicating prescribing errors with the cardiologist , giving patients information , preparation of a written overview of the discharge medication and communication to both the community pharmacist and the general practitioner about this medication . Within 6 weeks after discharge all patients were routinely scheduled to visit the outpatient clinic and medication discrepancies were measured . Main outcome measure The primary endpoint was the frequency of prescription errors in the discharge medication and medication discrepancies after discharge combined . Results Forty-four patients were included in the control group and 41 in the intervention group . Sixty-eight percent of patients in the control group had at least one discrepancy or prescription error against 39 % in the intervention group ( RR 0.57 ( 95 % CI 0.37–0.88 ) ) . The percentage of medications with a discrepancy or prescription error in the control group was 14.6 % and in the intervention group it was 6.1 % ( RR 0.42 ( 95 % CI 0.27–0.66 ) ) . Conclusion This clinical pharmacist discharge service significantly reduces the risk of discrepancies and prescription errors in medication of patients with heart failure in the 1st month after discharge OBJECTIVES To evaluate the effect of pharmaceutical care provided in addition to acute Geriatric Evaluation and Management ( GEM ) care on the appropriateness of prescribing . DESIGN R and omized , controlled trial , with the patient as unit of r and omization . SETTING Acute GEM unit . PARTICIPANTS Two hundred three patients aged 70 and older . INTERVENTION Pharmaceutical care provided from admission to discharge by a specialist clinical pharmacist who had direct contacts with the GEM team and patients . MEASUREMENTS Appropriateness of prescribing on admission , at discharge , and 3 months after discharge , using the Medication Appropriateness Index ( MAI ) , Beers criteria , and Assessing Care of Vulnerable Elders ( ACOVE ) underuse criteria and mortality , readmission , and emergency visits up to 12 months after discharge . RESULTS Intervention patients were significantly more likely than control patients to have an improvement in the MAI and in the ACOVE underuse criteria from admission to discharge ( odds ratio (OR)=9.1 , 95 % confidence interval (CI)=4.2 - 21.6 and OR=6.1 , 95 % CI=2.2 - 17.0 , respectively ) . The control and intervention groups had comparable improvements in the Beers criteria . CONCLUSION Pharmaceutical care provided in the context of acute GEM care improved the appropriate use of medicines during the hospital stay and after discharge . This is an important finding , because only limited data exist on the effect of various strategies to improve medication use in elderly in patients . The present approach has the potential to minimize risk and improve patient outcomes PURPOSE OF THE STUDY To determine the prevalence of delayed discharges of elderly in patients and associated costs . DESIGN AND METHODS We search ed Medline , Embase , Global Health , CAB Abstract s , Econlit , Web of Knowledge , EBSCO - CINAHL , The Cochrane Library , Health Management Information Consortium , and SCIE - Social Care Online for evidence published between 1990 and 2015 on number of days or proportion of delayed discharges for elderly in patients in acute hospitals . Descriptive and regression analyses were conducted . Data on proportions of delayed discharges were pooled using a r and om effects logistic model and the association of relevant factors was assessed . Mean costs of delayed discharge were calculated in USD adjusted for Purchasing Power Parity ( PPP ) . RESULTS Of 64 studies included , 52 ( 81.3 % ) reported delayed discharges as proportions of total hospital stay and 9 ( 14.1 % ) estimated the respective costs for these delays . Proportions of delayed discharges varied widely , from 1.6 % to 91.3 % with a weighted mean of 22.8 % . This variation was also seen in studies from the same country , for example , in the United Kingdom , they ranged between 1.6 % and 60.0 % . No factor was found to be significantly associated with delays . The mean costs of delayed discharge also varied widely ( between 142 and 31,935 USD PPP adjusted ) , reflecting the variability in mean days of delay per patient . IMPLICATION S Delayed discharges occur in most countries and the associated costs are significant . However , the variability in prevalence of delayed discharges and available data on costs limit our knowledge of the full impact of delayed discharges . A st and ardization of methods is necessary to allow comparisons to be made , and additional studies are required-preferably by disease area-to determine the postdischarge needs of specific patient groups and the estimated costs of delays Background Pharmacists may improve medication-related outcomes during transitions of care . The aim of the Iowa Continuity of Care Study was to determine if a pharmacist case manager ( PCM ) providing a faxed discharge medication care plan from a tertiary care institution to primary care could improve medication appropriateness and reduce adverse events , rehospitalization and emergency department visits . Methods Design . R and omized , controlled trial of 945 participants assigned to enhanced , minimal and usual care groups conducted 2007 to 2012 . Subjects . Participants with cardiovascular-related conditions and /or asthma or chronic obstructive pulmonary disease were recruited from the University of Iowa Hospital and Clinics following admission to general medicine , family medicine , cardiology or orthopedics . Intervention . The minimal group received admission history , medication reconciliation , patient education , discharge medication list and medication recommendations to inpatient team . The enhanced group also received a faxed medication care plan to their community physician and pharmacy and telephone call 3–5 days post-discharge . Participants were followed for 90 days post-discharge . Main Outcomes and Measures . Medication appropriateness index ( MAI ) , adverse events , adverse drug events and post-discharge healthcare utilization were compared by study group using linear and logistic regression , as models accommodating r and om effects due to pharmacists indicated little clustering . Results Study groups were similar at baseline and the intervention fidelity was high . There were no statistically significant differences by study group in medication appropriateness , adverse events or adverse drug events at discharge , 30-day and 90-day post-discharge . The average MAI per medication as 0.53 at discharge and increased to 0.75 at 90 days , and this was true across all study groups . Post-discharge , about 16 % of all participants experienced an adverse event , and this did not differ by study group ( p > 0.05 ) . Almost one-third of all participants had any type of healthcare utilization within 30 days post-discharge , where 15 % of all participants had a 30-day readmission . Healthcare utilization post-discharge was not statistically significant different at 30 or 90 days by study group . Conclusion The pharmacist case manager did not affect medication use outcomes post-discharge perhaps because quality of care measures were high in all study groups . Trial registration Clinical trials.gov registration : NCT00513903 , August 7 , 2007 BACKGROUND Adverse events related to drugs occur frequently among in patients , and many of these events are preventable . However , few data are available on adverse drug events among out patients . We conducted a study to determine the rates , types , severity , and preventability of such events among out patients and to identify preventive strategies . METHODS We performed a prospect i ve cohort study , including a survey of patients and a chart review , at four adult primary care practice s in Boston ( two hospital-based and two community-based ) , involving a total of 1202 out patients who received at least one prescription during a four-week period . Prescriptions were computerized at two of the practice s and h and written at the other two . RESULTS Of the 661 patients who responded to the survey ( response rate , 55 percent ) , 162 had adverse drug events ( 25 percent ; 95 percent confidence interval , 20 to 29 percent ) , with a total of 181 events ( 27 per 100 patients ) . Twenty-four of the events ( 13 percent ) were serious , 51 ( 28 percent ) were ameliorable , and 20 ( 11 percent ) were preventable . Of the 51 ameliorable events , 32 ( 63 percent ) were attributed to the physician 's failure to respond to medication-related symptoms and 19 ( 37 percent ) to the patient 's failure to inform the physician of the symptoms . The medication classes most frequently involved in adverse drug events were selective serotonin-reuptake inhibitors ( 10 percent ) , beta-blockers ( 9 percent ) , angiotensin-converting-enzyme inhibitors ( 8 percent ) , and nonsteroidal antiinflammatory agents ( 8 percent ) . On multivariate analysis , only the number of medications taken was significantly associated with adverse events . CONCLUSIONS Adverse events related to drugs are common in primary care , and many are preventable or ameliorable . Monitoring for and acting on symptoms are important . Improving communication between out patients and providers may help prevent adverse events related to drugs RATIONALE , AIMS AND OBJECTIVES To determine whether an increased input by clinical pharmacists at each stage of the patient 's hospital journey , from admission through discharge , result ed in an enhanced level of patient care as measured by a number of clinical and economic outcomes . METHODS This project was design ed to address medicines management issues in patients deemed at risk of drug-related problems . During the project , these latter patients at the time of admission were r and omly assigned to an integrated medicines management ( IMM ) service group ( n = 371 ) or regular hospital care group ( n = 391 ) . The IMM service involved comprehensive pharmaceutical care provided by a pharmacy team throughout each of three stages : patient admission , inpatient monitoring and counselling , and patient discharge . RESULTS Patients who received the IMM service benefited from a reduced length of hospital stay [ by 2 days ( P = 0.003 ; independent sample s t-test log(e ) ) ] . IMM patients also had a decreased rate of readmission over a 12-month follow-up period ( 40.8 % vs. 49.3 % ; p = 0.027 ; Fisher 's exact test ) and an increased time to readmission [ 20 days longer ( P = 0.0356 ; log rank test ) ] . A numbers-needed-to-treat calculation indicated that for approximately every 12 patients receiving the IMM service , one readmission to hospital , within 12 months of discharge , would be prevented . The new service was welcomed by cognate health care professionals . CONCLUSION The IMM service proved very effective and can be used as a template to support the implementation of comprehensive pharmaceutical care as a routine service across Northern Irel and and beyond Elderly patients are vulnerable to medication errors and adverse drug events due to increased morbidity , polypharmacy and inappropriate interactions . The objective of this study was to investigate whether systematic medication review and counselling performed by a clinical pharmacist and clinical pharmacologist would reduce length of in-hospital stay in elderly patients admitted to an acute ward of internal medicine . A r and omized , controlled study of 100 patients aged 70 years or older was conducted in an acute ward of internal medicine in Denmark . Intervention arm : a clinical pharmacist conducted systematic medication review s after an experienced medical physician had prescribed the patients ' medication . Information was
Output:
| The RCTs were from USA ( n = 3 ) , Sweden ( n = 2 ) , Belgium ( n = 2 ) , China ( n = 2 ) , Australia ( n = 2 ) , Denmark ( n = 2 ) , Northern Irel and , Norway , Canada , UK and Netherl and s. The economic studies were from UK ( n = 2 ) , Sweden ( n = 2 ) , Belgium and Netherl and s. The results showed that regular pharmacist input was most cost effective .
No evidence was found for 7-day pharmacist presence .
CONCLUSIONS Pharmacist inclusion in the ward multidisciplinary team improves patient safety and satisfaction and is cost-effective when regularly provided throughout the ward stay .
Research is needed to determine whether the provision of 7-day service is cost-effective |
MS210917 | ***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: This study evaluated the effects of brief monthly refresher training on CPR skill retention , confidence , and satisfaction with CPR skill level of 606 nursing students from ten different US schools . Students were r and omized to course type , HeartCode ™ Basic Life Support ( BLS ) or an instructor-led ( IL ) course , and then r and omized to a practice group , six minutes of monthly practice or no further practice . End-of- study survey results were compiled and reported as percentages . Short answer data were grouped by category for reporting . Fewer HeartCode ™ BLS students were satisfied with their CPR training compared to the IL students . Students who practice d CPR monthly were more confident than students who did not practice . Monthly practice improved CPR confidence , but initial course type did not . Students were most satisfied when they participated in the IL courses and frequent practice of CPR skills BACKGROUND The use of simulation to reproduce the experience of health care setting s and its use as a strategy in the teaching of nurses has grown at an unprecedented rate . There is little scientific evidence to examine the differences in satisfaction and gains perceived by the students with the use of medium and high fidelity . OBJECTIVES To analyse and benchmark gains and satisfaction perceived by nursing students , according to their participation in medium- and high-fidelity simulated practice . DESIGN R and omized control trial post-test only design with control group . SETTING AND PARTICIPANTS Students of the 4th year of the Bachelor 's Degree in Nursing who performed medium and high-fidelity simulated practice in a Simulation Centre environment . METHODS A satisfaction scale and a scale of perceived gains from the simulation were applied to the students who underwent simulated practice in a medium-fidelity environment ( control group ) and high-fidelity environment ( experimental group ) . Statistical analysis was performed and a significance level of p<0.05 was established . RESULTS Of the 85 students who participated in the study , the majority were female ( 92.94 % ) , with an average age of 21.89years ( SD=2.81years ) . Satisfaction is statistically significant in the realism dimension and overall satisfaction . In the gains perceived with the simulation there is a statistically significant difference in the dimension recognition/decision . CONCLUSION Students are very satisfied with the realism of high-fidelity simulated practice and consider that this helps them more with recognition and decision compared with the medium-fidelity simulation INTRODUCTION One of the newest teaching modalities in health education is the use of human patient simulators ( HPS ) . A simulation scenario creates a software program vignette in which nursing , medical , and other students interact with a manikin to practice caring for patients in a risk-free environment . Although used extensively in schools of nursing , there is little research that examines if these expensive simulators improve the clinical decision-making ability of nursing students . The purpose of this quasi-experimental differentiated treatment study was to assess if HPS technology leads to greater clinical decision-making ability and clinical performance compared to the teaching modality of a paper and pencil case study . METHODS Students ( n = 133 ) learning about the care of a patient with a myocardial infa rct ion at four licensed practical nursing programs ( LPN ) in Pennysylvania , USA were r and omly assigned to one of two groups at each site : an HPS simulation group or a paper and pencil case study group . One-tailed , independent t-tests were used to compare learning gains measured by differences in pre- and post clinical decision-making exam scores and clinical performance . RESULTS Results indicated that students in the simulation groups were significantly more likely to score higher on the clinical decision-making exams and to respond clinical ly by performing CPR more quickly on the manikin than students in the case study groups . On the 100-point exam , the simulation groups had a 20-point gain , while the case study groups had a 12-point gain ( P < 0.001 ) . Students in the simulation groups provided CPR to a manikin 30 seconds faster , on an average ( P < 0.001 ) . DISCUSSION Results vali date the use of HPS technology in nursing education . Ultimately patients may benefit from increased knowledge and speed of care from practical nurses whose training was improved through the use of HPS technology BACKGROUND Clinical simulations can provide students with realistic clinical learning environments to increase their knowledge , self-confidence , and decrease their anxiety prior to entering clinical practice setting s. OBJECTIVE To compare the effectiveness of two maternal newborn clinical simulation scenarios ; virtual clinical simulation and face-to-face high fidelity manikin simulation . DESIGN R and omized pretest-posttest design . SETTING A public research university in Canada . PARTICIPANTS Fifty-six third year Bachelor of Science in Nursing students . METHODS Participants were r and omized to either face-to-face or virtual clinical simulation and then to dyads for completion of two clinical simulations . Measures included : ( 1 ) Nursing Anxiety and Self-Confidence with Clinical Decision Making Scale ( NASC-CDM ) ( White , 2011 ) , ( 2 ) knowledge pretest and post-test related to preeclampsia and group B strep , and ( 3 ) Simulation Completion Question naire . Before and after each simulation students completed a knowledge test and the NASC-CDM and the Simulation Completion Question naire at study completion . RESULTS There were no statistically significant differences in student knowledge and self-confidence between face-to-face and virtual clinical simulations . Anxiety scores were higher for students in the virtual clinical simulation than for those in the face-to-face simulation . Students ' self-reported preference was face-to-face citing the similarities to practicing in a ' real ' situation and the immediate debrief . Students not liking the virtual clinical simulation most often cited technological issues as their rationale . CONCLUSIONS Given the equivalency of knowledge and self-confidence when undergraduate nursing students participate in either maternal newborn clinical scenarios of face-to-face or virtual clinical simulation identified in this trial , it is important to take into the consideration costs and benefits /risks of simulation implementation BACKGROUND There is a gap in the literature regarding learning outcomes linked to the use of high-fidelity simulators compared to that of traditional teaching methods . AIM To examine the effect of using high-fidelity simulators on knowledge and skills acquisition and retention with university students . METHODS A r and omized two-arm trial using two different educational approaches on 90 nursing students assigned r and omly to two groups was used at two points of time . FINDINGS The results showed significant differences in favor of the participants in the high-fidelity simulator group on both the acquisition and retention of knowledge and skills over time . However , a significant loss of cardiopulmonary resuscitation knowledge and skills occurred at 3 months after training in both groups . CONCLUSIONS The findings of this study may assist educators in integrating high-fidelity simulators in education and training . In addition , the findings may help nursing educators to arrange additional cardiopulmonary resuscitation training sessions in order to improve cardiac arrested patients ' outcomes . LINKING EVIDENCE TO ACTION High-fidelity simulation ( HFS ) provides students with interactive learning experiences in a safe controlled environment . HFS enables teachers to implement critical clinical scenarios , such as cardiac arrest , without risk to patients . Integrating the simulation training into nursing curricula will help to overcome the challenges that face many courses , specifically the shortage of clinical areas for training and the increase in numbers of nursing students PURPOSE To investigate occupational exposures to biological material potentially infected by blood-borne viruses in nursing student population during the course years . DESIGN AND METHODS An observational retrospective study was design ed . Data were collected in May 2007 . Two-thous and -two-hundred-fifteen nursing students from the 3 years of degree course were enrolled in the four Italian universities . A structured question naire was constructed and was given out unannounced to nursing students in four universities on a r and omly chosen day . The likelihood of association between nursing student exposure and certain assumed risk factors was measured . FINDINGS The exposure risk is associated with each study year of nursing students . Specifically , the probability of accidental exposure is reduced significantly with the increase of clinical skills during the training period . The risk for exposure in the 1st year students appears significantly higher than in those of the next years ( odds ratio [ OR ] 1.465 ; 95 % confidence interval [ CI ] 1.105 - 1.943 ) . Data highlighted a gradual increase of bio-safety knowledge in nursing students from the 1st to the 3rd years of study . However , a statistically significant association exists only between awareness of a correct use of gloves and exposure risk ( OR 0.435 ; 95%CI 0.227 - 0.834 ) . Mucocutaneous exposures are more frequent than percutaneous exposures ( 62.2 % ) , and the hollow-bore needle is the device most often involved . In 42.5 % of cases , accidental exposures occurred when nursing students are working alone in a medical ward or surgery area . CONCLUSIONS During their clinical training , nursing students can encounter a real risk for percutaneous and mucocutaneous exposures to blood potentially infected with blood-borne viruses . However , this risk is reduced with an increase in clinical skills . CLINICAL RELEVANCE Results show that some new strategies are necessary for exposure risk reduction such as development of simulation laboratories for nursing practice and the adequate presence of tutors in clinical training education Epidemiological evidence about the accuracy of diagnostic tests , the power of prognostic markers , and the efficacy and safety of interventions is the cornerstone of evidence -based health care.1 Practitioners of evidence -based health care require critical appraisal skills to judge the validity of this evidence . The Evidence -Based Medicine ( EBM ) Working Group members are international leaders in teaching critical appraisal skills , and their users ’ guides for appraising the validity of the healthcare literature 2 have long been the basis of teaching programmes worldwide . However , we found that many of our students took a reductionist “ paint by numbers ” approach when using the Working Group ’s guides . Students could answer individual appraisal questions correctly but would have difficulty assessing overall study quality . We believe this is due to a poor underst and ing of epidemiological study design . So over the past 15 years of teaching critical appraisal we have modified the EBM Working Group approach and developed the Graphic Appraisal Tool for Epidemiological studies ( GATE ) frame to help our students conceptualise the whole study as well as its component parts . GATE is a visual framework that illustrates the generic design of all epidemiological studies ( figure 1 ) . We now teach critical appraisal by “ hanging ” studies and the EBM Working Group ’s appraisal questions on the GATE frame . Figure 1 The GATE frame . This editorial outlines the GATE approach to critical appraisal , illustrated throughout using the Heart and Estrogen/progestin Replacement Study ( HERS ) , a r and omised , double blind , placebo controlled trial of the effect of daily oestrogen plus progestin on coronary heart disease ( CHD ) death in postmenopausal women.3 A detailed critical appraisal of HERS using a GATE-based checklist is available online.4 The GATE frame incorporates a triangle , circle , square , and arrow ( figure 1 ) , labelled with the acronym PECOT ( or PICOT ) . The triangle ( figure 2 ) represents the population studied : “ P ” for population or BACKGROUND An undergraduate nursing health assessment course provided three experiential modalities for practicing health assessment skills : high-fidelity human simulators ( HFS ) , st and ardized patients ( SP ) and community volunteers ( CV ) . Previous research has examined the impact of each distinct modality on learning outcomes . However , few studies have compared these learning strategies . This study investigates learners ' satisfaction , self-efficacy and performance behaviors among three learning approaches . METHOD Forty-four undergraduate nursing students were r and omly assigned to perform focused respiratory assessment s on a HFS , SP or CV . Participants completed the Health Assessment Educational Modality Evaluation ( HAEME ) survey to assess self-efficacy and modality satisfaction . A performance checklist evaluated assessment skills . RESULTS Performance behaviors were significantly greater with HFS , but learners were significantly less satisfied with this modality . Significant differences in students ' self-efficacy were not found across the three modalities . CONCLUSIONS Significantly lower satisfaction with HFS may reflect learners ' perceived lack of realism . However , HFS may provide a low-stress opportunity for novice learners to practice skills . Results support the integration of distinct experiential learning modalities in an undergraduate nursing health assessment course Patient simulation is increasingly used in the education of healthcare providers , yet few studies have compared simulation to other teaching modalities . The purpose of this study was to determine differences in knowledge acquisition and student satisfaction between two methods of teaching the principles of mechanical ventilation to advanced practice nursing ( APN ) students : high-fidelity patient simulation ( including face-to-face instruction ) versus an online , narrated PowerPoint presentation . Twenty APN students were r and omized to either the simulation or online teaching method in this pre/posttest study . Measures included a 12-item knowledge question naire and a 5-item satisfaction survey . Both groups had significant improvement in knowledge scores from pretest to posttest , but knowledge scores were not significantly different at posttest between groups . Student satisfaction with their learning method was significantly higher in the simulation group . Students choosing to participate in the alternative teaching method after study completion preferred the simulation to the online method Nursing actively engages various technologies to enhance education and training with increased learner confidence and patient safety . Simulation is a key technology to address the strain on the current nursing education system . The purpose of this study was to determine the effect of simulation-enhanced orientation on pediatric acute care examination scores and pediatric clinical course grade s among junior-level baccalaureate nursing students . No significant difference between groups ( p < 0.05 ) was detected for the students ' examination scores . Clinical grade s of the intervention group ( mean =
Output:
| Compared with other teaching methods , HFPS revealed higher effects sizes on nursing students ' knowledge and performance . |
MS210918 | ***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 role of weight training in the primary prevention of type 2 diabetes mellitus ( T2DM ) is largely unknown . METHODS To examine the association of weight training with risk of T2DM in US men and to assess the influence of combining weight training and aerobic exercise , we performed a prospect i ve cohort study of 32 002 men from the Health Professionals Follow-up Study observed from 1990 to 2008 . Weekly time spent on weight training and aerobic exercise ( including brisk walking , jogging , running , bicycling , swimming , tennis , squash , and calisthenics/rowing ) was obtained from question naires at baseline and biennially during follow-up . RESULTS During 508 332 person-years of follow-up ( 18 years ) , we documented 2278 new cases of T2DM . In multivariable-adjusted models , we observed a dose-response relationship between an increasing amount of time spent on weight training or aerobic exercise and lower risk of T2DM ( P < .001 for trend ) . Engaging in weight training or aerobic exercise for at least 150 minutes per week was independently associated with a lower risk of T2DM of 34 % ( 95 % CI , 7%-54 % ) and 52 % ( 95 % CI , 45%-58 % ) , respectively . Men who engaged in aerobic exercise and weight training for at least 150 minutes per week had the greatest reduction in T2DM risk ( 59 % ; 95 % CI , 39%-73 % ) . CONCLUSIONS Weight training was associated with a significantly lower risk of T2DM , independent of aerobic exercise . Combined weight training and aerobic exercise conferred a greater benefit Background Increased exercise capacity favourably influences clinical outcomes after transcatheter aortic valve implantation . In our SPORT : TAVI r and omised pilot trial , eight weeks of endurance and resistance training ( training group , TG ) shortly after transcatheter aortic valve implantation result ed in significantly improved exercise capacity , muscular strength and quality of life compared to usual care ( UC ) . However , the long-term clinical benefits of such an intervention are unknown . Design A r and omised controlled trial . Methods SPORT : TAVI participants underwent re assessment of trial endpoints 24 ± 6 months after baseline : maximal oxygen uptake ( VO2peak ) and anaerobic threshold ( VO2AT ) were assessed with cardiopulmonary exercise testing , muscular strength with one-repetition maximum testing , quality of life with the Kansas City cardiomyopathy and medical outcomes study 12-item short-form health survey question naires , and prosthetic aortic valve function with echocardiography . Results Of 27 original participants ( TG 13 ; UC 14 ; age 81 ± 6 years ) , more patients had died during follow-up in UC ( n = 5 ) than in TG ( n = 2 ; P = 0.165 ) ; three further patients ( TG 1 ; UC 2 ) were unavailable for other reasons . In the remaining patients ( TG 10 ; UC 7 ) , a significant between-group difference in favour of TG was observed for change in VO2AT from baseline ( 2.7 ml/min/kg ( 95 % confidence interval 0.8–4.6 ) ; P = 0.008 ) , but not for change in VO2peak ( 2.1 ml/min/kg ( –1.1–5.4 ) ; P = 0.178 ) . Changes in muscular strength and quality of life did not differ between groups over time . Overall , prosthetic valve function remained intact in both groups . Conclusions Eight weeks of exercise training shortly after transcatheter aortic valve implantation result ed in preserved long-term improvements in VO2AT , but not VO2peak , muscular strength or quality of life compared to usual care . The findings emphasise the importance of ongoing exercise interventions following transcatheter aortic valve implantation to maintain initial improvements long term . Clinical Trial Registration ( original trial ) : Clinical trials.gov NCT01935297 BACKGROUND Exercise has been reported to decrease cancer-related fatigue and to increase quality of life ( QoL ) in various breast cancer ( BC ) population s. However , studies investigating exercise during radiotherapy or resistance training are scarce . We conducted a r and omized , controlled trial ( BEST study ) to assess the efficacy of 12-week resistance training on fatigue beyond possible psychosocial effects of a group-based intervention . PATIENTS AND METHODS One hundred sixty patients with BC stage 0-III were r and omly assigned to a 12-week progressive resistance training ( 2 times/week ) or a 12-week relaxation control ( RC , 2 times/week ) . Both interventions were group-based . The primary end point fatigue was assessed with a 20-item multidimensional question naire , QoL with EORTC question naires . Statistical analyses were based on analysis of covariance models for the individual changes from baseline to week 13 . RESULTS Adherence to the intervention program as well as the completion rate ( 97 % ) for the primary outcome variable fatigue was high . In intention-to-treat analyses for the N = 155 patients , significant between-group mean differences ( MD ) favoring the exercise group ( EX ) were observed for general fatigue ( P = 0.044 ) , especially for the subscale physical fatigue [ MD = -0.8 ; 95 % confidence interval -1.5 to -0.2 , P = 0.013 ] , but not for affective ( P = 0.91 ) or cognitive fatigue ( P = 0.65 ) . For QoL , significantly larger improvements regarding the role function ( P = 0.035 ) and pain ( P = 0.040 ) were noted among exercisers compared with RCs . Future perspective improved significantly stronger in the RC group compared with the EX group ( P = 0.047 ) . CONCLUSIONS The 12-week resistance training program was a safe , feasible and efficacious strategy to improve cancer-related fatigue and components of QoL in BC patients during adjuvant radiotherapy . As exercise was compared with another group-based intervention , results indicate that resistance training effects on fatigue and QoL go beyond psychosocial benefits , and that the clinical ly relevant overall benefit of resistance exercise compared with usual care can be assumed to be higher . TRIAL REGISTRATION Clinical Trials.gov NCT01468766 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 Background : Resistance training ( RT ) improves muscular strength , physical functioning and quality of life in prostate cancer survivors , but the optimal frequency of RT is unknown . We conducted a pilot r and omized controlled trial to compare the effects of 3 versus 2 days per week of RT in prostate cancer survivors diagnosed within the past 2 years . Methods : Prostate cancer survivors ( N=30 ) were r and omized to 12 weeks of supervised RT performed either 3 days per week ( n=16 ) or 2 days per week ( n=14 ) . The primary outcome was muscular strength assessed by a multiple repetition maximum test at baseline and postintervention . Secondary outcomes were objective physical functioning , quality of life and psychosocial functioning . Results : A trend ( P<0.10 ) and /or potentially meaningful effects ( st and ardized effect size d⩾0.20 ) were found favoring 3 days per week over 2 days per week for the primary outcome of lower body strength ( mean difference=27.8 kg ; 95 % confidence interval=−0.9 to 56.5 ; P=0.057 ; d=0.72 ) and for the secondary outcomes of 30-s chair st and ( d=0.29 ; P=0.31 ) , sit and reach ( d=0.24 ; P=0.33 ) , 6 -min walk ( d=0.21 ; P=0.42 ) and the physical component summary ( d=0.21 ; P=0.41 ) . Conversely , a trend and /or potentially meaningful effects were found favoring 2 days per week over 3 days per week for the mental component summary ( d=−0.38 ; P=0.10 ) , mental health ( d=−0.44 ; P=0.11 ) , vitality ( d=−0.31 ; P=0.28 ) , role-emotional ( d=−0.23 ; P=0.43 ) , anxiety ( d=0.32 ; P=0.29 ) , happiness ( d=−0.31 ; P=0.36 ) and perceived stress ( d=0.23 ; P=0.39 ) . Conclusions : This pilot r and omized dose – comparison trial provides preliminary data to suggest that RT 3 days per week compared with 2 days per week may improve the strength and physical functioning in prostate cancer survivors , but may also blunt improvements in psychosocial functioning . Larger and more targeted phase II and III trials are needed to confirm the potentially complex effects of RT frequency in prostate cancer survivors BACKGROUND Resistance training has been introduced in cardiac rehabilitation to give more benefit than traditional training . Haemodynamic evaluation of cardiac patients to resistance training has generally consisted of continuous HR monitoring and discontinuous blood pressure measurements . DESIGN AND METHODS Blood pressure ( BP ) and heart rate ( HR ) responses to resistance training were evaluated using continuous monitoring ( Finapres ) during low ( four sets of 17 repetitions at 40 % of the one-repetition maximum strength [ 1-RM ] ) and high intensity resistance training ( four sets of 10 repetitions at 70 % of 1-RM ) on a leg extension machine in 14 patients who participated in a rehabilitation programme . Work volume was identical in the low- and high-level resistance training . RESULTS The HR and systolic blood pressure ( SBP ) during low intensity resistance training were always larger than during high intensity ( P<0.001 ) . Peak SBP increased from set 1 to set 3 and 4 during both low and high intensity resistance training ( P<0.05 ) . Peak HR was larger in set 4 ( 95+/-11 bpm ) than in set 1 only during low intensity resistance training ( 91+/-12 bpm ) ( P<0.05 ) . One-minute recovery periods did not allow a return to baseline HR and SBP during both low and high intensity modalities . CONCLUSIONS The SBP and HR responses to resistance training are related to the duration of exercise . Sets with < or = 10 repetitions of high intensity should be preferred to longer sets with low intensity . Pauses between exercise sets should exceed 1 min . Blood pressure should be measured during the last repetitions of the exercise set OBJECTIVE To examine the individual , combined , and isolated effects of movement-based behaviors ( MBBs ) on all-cause mortality and CVD-specific mortality . METHODS The present prospect i ve study included data from the 1999 - 2004 National Health & Nutrition Examination Survey , with follow-up data through December 31 , 2006 ( N=12,321 U.S. adults ) . Measures included self-report engagement in 4 MBBs ( moderate-intensity exercise , vigorous-intensity exercise , muscular strength activities , and active transport ) , with all-cause mortality and CVD-specific mortality as the outcome measures . RESULTS Regarding all-cause mortality , the hazard ratio for those with 1 ( vs. 0 ) , 2 ( vs. 0 ) , and 3 - 4 ( vs. 0 ) MBBs , respectively , was 0.61 ( 95 % CI : 0.49 - 0.76 ) , 0.49 ( 95 % CI : 0.36 - 0.66 ) , and 0.24 ( 95 % CI : 0.16 - 0.37 ) . The only MBBs independently associated with all-cause-mortality were vigorous exercise ( HR=0.56 ; 95 % CI : 0.41 - 0.76 ) and moderate-intensity exercise ( HR=0.58 ; 95 % CI : 0.45 - 0.74 ) . When examining the isolation/exclusivity effects of the MBBs , the only MBB performed in isolation that was statistically significantly associated with all-cause mortality was " Only VPA " ( HR=0.45 ; 95 % CI : 0.23 - 0.86 ) . CVD-specific mortality results were similar to the all-cause mortality results . CONCLUSIONS There was little evidence of a MBB isolation effect on mortality risk , but individuals engaging in more MBBs had a lower risk of all-cause mortality and CVD-specific mortality . These findings suggest that , in addition to promoting greater engagement in overall physical activity , recommendations for adults to engage in multiple MBBs may be advisable Background Exercise training is effective for improving physical fitness and physical function in people with type 2 diabetes . However , limited research has been conducted on the optimal exercise training intensity for this population . Objective The primary study objective was to investigate the effects of moderate- versus high-intensity exercise training on physical fitness and physical function in
Output:
| In addition , resistance training showed no significant association with cancer mortality .
Conclusion Resistance training is associated with lower mortality and appears to have an additive effect when combined with aerobic exercise .
There are insufficient data to determine the potential beneficial effect of resistance training on non-fatal events or the effect of substituting aerobic exercise with resistance training |
MS210919 | ***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: Small airways disease plays an important role in the pathogenesis of asthma , but assessment of small airways impairment is not easy in everyday clinical practice . The small airways can be examined by several invasive and noninvasive methods , most of which can at present be used only in the experimental setting . Inhalers providing extrafine inhaled corticosteroid particle sizes may achieve sufficient deposition in the peripheral airways . Many studies have reported the beneficial effects of extrafine inhaled corticosteroids on inflammation , ie , on dysfunction in both the central and distal airways in asthmatics , and there are some data on asthma phenotypes in which the small airways seem to be affected more than in other phenotypes , including nocturnal asthma , severe steroid-dependent or difficult-to-treat asthma , asthma complicated by smoking , elderly asthmatic patients and /or patients with fixed airflow obstruction , and asthmatic children . The relevant r and omized controlled clinical trials indicate that the efficacy of extrafine and nonextrafine inhaled corticosteroid formulations is similar in terms of primary endpoints , but there are certain clinical ly important endpoints for which the extrafine formulations show additional benefits Purpose : Results of r and omized controlled trials may not predict effectiveness of inhaled corticosteroids ( ICS ) in real-world clinical practice , where inhaler technique and device characteristics can influence effectiveness . We compared asthma outcomes for ICS delivered via three different inhaler devices : pressurized metered-dose inhaler ( pMDI ) , breath-actuated MDI ( BAI ) , and dry powder inhaler ( DPI ) . Patients and methods : This retrospective data base study evaluated 1-year outcomes for primary care patients with asthma aged 5–60 years prescribed their first ICS ( initiation population ) by pMDI ( n = 39,746 ) , BAI ( n = 9809 ) , or DPI ( n = 6792 ) , or their first ICS dose increase ( step-up population ) by pMDI ( n = 6245 ) , BAI ( n = 1388 ) , or DPI ( n = 1536 ) . Co- primary outcome measures were composite proxy measures of asthma control ( no hospital attendance for asthma , oral corticosteroids , or antibiotics for lower respiratory infection ) and severe exacerbations ( unscheduled hospital admission , emergency room attendance , or oral corticosteroids ) . Outcomes were adjusted for potential confounding factors identified during a baseline year . Results : In the initiation population , adjusted odds ratios ( 95 % confidence intervals [ CI ] ) for asthma control , as compared with pMDIs , were significantly better for BAIs ( 1.08 [ 1.02–1.14 ] ) and DPIs ( 1.13 [ 1.06–1.21 ] ) , while adjusted exacerbation rate ratios ( 95 % CI ) were 1.00 ( 0.93–1.08 ) and 0.88 ( 0.81–0.95 ) , respectively . In the step-up population , adjusted odds of asthma control were 1.21 ( 1.05–1.39 ) for BAIs and 1.13 ( 0.99–1.29 ) for DPIs ; adjusted exacerbation rate ratios were 0.83 ( 0.71–0.98 ) for BAIs and 0.85 ( 0.74–0.98 ) for DPIs , compared with pMDIs . Conclusion : Inhaler device selection may have a bearing on clinical outcomes . Differences in real-world effectiveness among these devices require closer evaluation in well- design ed prospect i ve trials Chronic bronchitis is associated with airways obstruction and inflammation . In order to determine whether aerosolized beclomethasone can modulate airway inflammation and diminish airway obstruction , subjects with chronic bronchitis performed spirometry and underwent bronchoalveolar lavage ( BAL ) before and after receiving 6 wk of therapy ( five puffs four times a day ) with either aerosolized beclomethasone ( n = 20 ) or placebo ( n = 10 ) in a double-blinded , r and omized fashion . All subjects received aerosolized albuterol before each use of the study medications . Before BAL , the airways were visually assessed for the appearance of inflammation and assigned a score , the bronchitis index . BAL was performed by instilling five 20-ml aliquots of saline into each of three sites and pooling and separately analyzing the returns from the first aliquots to yield a " bronchial sample . " The bronchial lavages were repeated in an additional three sites to increase the volume of fluid available for analysis . The fluid was prepared for cytologic examination by cytocentrifugation . Albumin ( as a measure of epithelium permeability ) and lactoferrin and lysozyme ( as measures of serous cell activity ) were measured in unconcentrated BAL fluid by enzyme-linked immunosorbent assay , and concentrations in epithelial lining fluid were estimated using urea as an internal marker for dilution . After treatment , the beclomethasone group , but not the placebo group , showed improvement in FVC ( p = 0.02 ) , FEV1 ( p = 0.002 ) , and 25 to 75 % forced expiratory flow ( p = 0.006 ) . Associated with the improvement in spirometry , the bronchitis index fell ( 13.5 + /- 1.0 versus 10.75 + /- 1.1 , p = 0.02 ) in the beclomethasone-treated group , but not the placebo-treated group . ( ABSTRACT TRUNCATED AT 250 WORDS Bone mass and biochemical bone markers were prospect ively studied in 33 patients with chronic obstructive pulmonary disease treated for 1 year with inhaled beclomethasone 200 micrograms/q.i.d . ( group A , 8 men and 4 women ) , inhaled budesonide 200 micrograms/q.i.d . ( group B , 6 men and 5 women ) , or not requiring steroids ( group C , 6 men and 4 women ) . Both inhaled corticosteroids decreased serum concentrations of the osteoblastic markers , osteocalcin and carboxy-terminal propeptide of type I collagen ( PICP ) . The osteoclastic marker cross-linked carboxy-terminal telopeptide of type I collagen ( ICTP ) increased significantly more in patients on beclomethasone than in those on budesonide . The decrease in bone mineral density was more pronounced in patients treated with beclomethasone ( 1.1 % in the spine 1.7 % in the hip P < 0.05 ) compared to those treated with budesonide ( 0.6 % in both spine and hip ) or in the control group . Inhaled corticosteroids affect biochemical bone markers and bone mineral density , but there is a different effect for the two corticosteroids evaluated in the present study One hundred and twenty seven adults considered on clinical grounds to have non-asthmatic chronic airflow obstruction entered a r and omised , double blind , placebo controlled , crossover trial comparing the physiological response to inhaled beclomethasone dipropionate 500 micrograms thrice daily with oral prednisolone 40 mg a day , both given for two weeks . One hundred and seven patients completed the study . Response was assessed as change in FEV1 and FVC measured on the last treatment day , and as change in mean peak expiratory flow ( PEF ) over the final seven days of treatment from home PEF recordings performed five times daily . A full response to treatment was defined as an increase in FEV or FVC , or an increase in mean daily PEF over the final seven days of treatment , of at least 20 % from baseline values . An improvement in one measurement of at least 15 % , or of 10 % in any two measurements , was defined as a partial treatment response . Response to placebo showed a significant order effect , suggesting a carry over effect of active treatment of at least three weeks . Response to active treatment was therefore related to initial baseline values , and compared with placebo by considering responses in the first treatment phase only . A full response to oral prednisolone ( 16/38 ) was significantly more common than to placebo ( 3/35 ) . The number of full responses to inhaled beclomethasone ( 8/34 ) did not differ significantly from the number responding to oral prednisolone or placebo in the first treatment phase , though full and partial responses to inhaled beclomethasone ( 12/34 ) were significantly more common than those to placebo ( 4/35 ) . When all three treatment phases were considered 44/107 patients showed a full response to one or both forms of corticosteroid treatment , a response to prednisolone ( 39 ) occurring more frequently than to inhaled beclomethasone ( 26 ) . Only 21 of the 44 responders showed a response to both forms of treatment . Inhaled beclomethasone dipropionate 500 micrograms thrice daily was inferior to oral prednisolone 40 mg per day , but better than placebo , in producing improvement in physiological measurements in patients thought to have nonasthmatic chronic airflow obstruction . It was , however , an effective alternative in over half of those showing a response to prednisolone BACKGROUND --High dose inhaled glucocorticosteroids are increasingly used in the management of patients with moderate to severe asthma . Although effective , they may cause systemic side effects . Fluticasone propionate is a topically active inhaled glucocorticosteroid which has few systemic effects at high doses . METHODS --Fluticasone propionate , 1.5 mg per day , was compared with beclomethasone dipropionate at the same dose for one year in patients with symptomatic moderate to severe asthma ; 142 patients received fluticasone propionate and 132 received beclomethasone dipropionate . The study was multicentre , double blind and of a parallel design . For the first three months patients attended the clinic every four weeks and completed daily diary cards . For the next nine months they were only seen at three monthly intervals in the clinic . RESULTS --During the first three months diary card peak expiratory flow ( PEF ) rate and lung function measurements in the clinic showed significantly greater improvement in patients receiving fluticasone propionate ( difference in morning PEF 15 l/min ( 95 % CI 6 to 25 ) ) , and these differences were apparent at the end of the first week . The improved lung function was maintained throughout the 12 month period and the number of severe exacerbations in patients receiving fluticasone propionate was reduced by 8 % compared with those receiving beclomethasone dipropionate . No significant differences between the two groups were observed in morning plasma cortisol levels , urinary free cortisol levels , or response to synthetic ACTH stimulation . In addition , both the rates of withdrawal and of adverse events were low , and there were fewer exacerbations of asthma with fluticasone propionate than beclomethasone dipropionate . CONCLUSIONS --This study shows that fluticasone propionate in a daily dose of 1.5 mg results in a significantly greater increase in PEF and asthma control than the same dose of beclomethasone dipropionate , with no increase in systemic or other side effects BACKGROUND : In a previous single dosing comparison between fluticasone propionate and budesonide differences in cortisol levels measured at 08.00 hours were observed at doses in excess of 1000 micrograms . The aim of this study was to compare the adrenal suppression caused by chronic twice daily dosing with inhaled fluticasone propionate ( FP ) and budesonide ( B ) given on a microgram equivalent basis by metered dose inhaler to asthmatic patients . METHODS : Twelve stable asthmatic patients of mean age 29.7 years with forced expiratory volume in one second ( FEV1 ) 89.0 % predicted and mid forced expiratory flow ( FEF25 - 75 ) 58.9 % predicted , on 400 micrograms/day or less of inhaled corticosteroid , were studied in a double blind , placebo controlled , crossover design comparing inhaled budesonide and fluticasone propionate in doses of 250 micrograms , 500 micrograms , and 1000 micrograms twice daily . Each dose was given at 08.00 hours and 22.00 hours for four days by metered dose inhaler with mouth rinsing . Measurements were made of overnight urinary cortisol excretion and plasma cortisol levels at 08.00 hours , 10 hours after the eighth dose . RESULTS : The plasma cortisol levels ( nmol/ l ) at 08.00 hours showed that fluticasone propionate produced lower cortisol levels than budesonide at all three dose levels : F500 333.8 , B500 415.2 ( 95 % CI 28.9 to 134.0 ) ; F1000 308.3 , B1000 380.3 ( 95 % CI 10.5 to 133.5 ) ; F2000 207.3 , B2000 318.5 ( 95 % CI 5.8 to 216.7 ) ; placebo 399.9 . Fluticasone produced greater effects than budesonide on the overnight urinary cortisol/creatinine ratio
Output:
| Participants receiving BDP/LABA also had a statistically significant increased rate of exacerbations leading to hospitalisation ( risk ratio ( RR ) 1.84 , 95 % CI 1.17 to 2.90 , P = 0.008 ) ( moderate quality ) , although this finding is debatable as this study 's post hoc analysis showed no statistically significant difference when accounting for country-specific differences in hospitalisation policies . |
MS210920 | ***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: Abstract Background : Falls and fall-related injuries are symptomatic of an aging population . This study aim ed to design , develop , and deliver a novel method of balance training , using an interactive game-based system to promote engagement , with the inclusion of older adults at both high and low risk of experiencing a fall . Study Design : Eighty-two older adults ( 65 years of age and older ) were recruited from sheltered accommodation and local activity groups . Forty volunteers were r and omly selected and received 5 weeks of balance game training ( 5 males , 35 females ; mean , 77.18 ± 6.59 years ) , whereas the remaining control participants recorded levels of physical activity ( 20 males , 22 females ; mean , 76.62 ± 7.28 years ) . The effect of balance game training was measured on levels of functional balance and balance confidence in individuals with and without quantifiable balance impairments . Results : Balance game training had a significant effect on levels of functional balance and balance confidence ( P < 0.05 ) . This was further demonstrated in participants who were deemed at high risk of falls . The overall pattern of results suggests the training program is effective and suitable for individuals at all levels of ability and may therefore play a role in reducing the risk of falls . Conclusions : Commercial hardware can be modified to deliver engaging methods of effective balance assessment and training for the older population BACKGROUND the study compares the effects of a Nintendo Wii exercise programme and a st and ard Gym-based exercise intervention on fear of falling , knee strength , physical function and falls rate in older adults . METHODS eighty community-dwelling adults aged 60 years and above with short physical performance battery score of 5 - 9 points and modified falls efficacy scale ( MFES ) score of ≤9 points participated in the parallel-group r and omised trial . Each intervention arm involved an hour of intervention per week , totalling 12 sessions over 12 weeks . Besides 1-year fall incidence , the participants were evaluated on MFES , knee extensor strength ( KES ) , timed-up- and -go test , gait speed , 6-minute walk test and narrow corridor walk test at weeks 13 and 24 . RESULTS at week 13 , between interventions , the effect of MFES changes did not reach statistical significance ( difference = -0.07 point , 95 % CI -0.56 to 0.42 , P = 0.78 ) ; at week 24 , the Wii group showed statistically significant effects over the Gym group ( difference = 0.8 point , 95 % CI 0.27 to 1.29 , P < 0.01 ) . For KES , the two groups did not differ statistically at week 13 ( difference = -2.0 % , 95 % CI -5.6 to -1.7 , P = 0.29 ) ; at week 24 , the Gym group had greater strength gains than the Wii group ( difference = -5.1 % , 95 % CI -8.7 to -1.5 , P < 0.01 ) . No between-group differences were observed for other outcome measures . CONCLUSION on completion of a 12-week Nintendo Wii exercise programme , there was no significant benefit seen on fear of falling when compared to a st and ard Gym-based exercise intervention ; however , post-intervention there was an apparent reduction in fear of falling in the group allocated to Wii training , despite knee strength apparently improving more in those allocated to the Gym . It is possible that long-term gains after using the Wii might be due to a carry-over effect . TRIAL REGISTRATION Australian New Zeal and Clinical Trials Registry , ACTRN12610000576022 BACKGROUND Many issues prevent elderly individuals from exercising in daily life . There is a need for a system that allows elderly individuals to engage in exercise regularly at a low cost . We developed an exergame that uses a Kinect ( ® ) sensor ( Microsoft Corp. , Redmond , WA ) and conducted a r and omized controlled trial of the effects of using this exergame on muscle strength and balance in healthy elderly individuals . SUBJECTS AND METHODS We enrolled 57 healthy elderly individuals and r and omly divided them into an intervention group ( n=29 ) and a control group ( n=28 ) using a table of r and om numbers . All participants underwent gait analyses and were examined using the Berg Balance Scale ( BBS ) , Functional Reach Test ( FRT ) , and the 30-second chair-st and ( CS-30 ) test before the intervention . Participants in the intervention group played the exergame once or twice a week , up to a total of 24 times . The tests were repeated after intervention , and the scores were compared with those obtained before intervention . RESULTS Our results indicated that walking , muscle strength , and motor function improved in participants in the intervention group . Decreased double st and ing time ( P=0.03 ) , minimum foot clearance ( P=0.04 ) , BBS scores ( P<0.01 ) , CS-30 scores ( P<0.01 ) , and FRT scores ( P<0.01 ) significantly improved in the intervention group compared with values in the control group . CONCLUSIONS The Kinect-based exergame developed in this study was found to be effective in improving walking , muscular strength , and balance in elderly people Background Falls are a leading cause of injury and death for old adults , with one risk factor for falls being balance deficits . The low cost ( < 400 USD ) , wide availability , and ability to incorporate multiple training paradigms make gaming systems appealing as possible balance intervention tools . Aims To investigate the feasibility of using the Xbox Kinect for training to improve clinical measures of balance in old adults and retain improvements after a period of time . Methods Thirteen healthy old adults ( aged 70 + years ) were r and omly divided into two groups . The experimental group completed Kinect training three times a week for 3 weeks while the control group continued with normal activities . Four clinical measures of balance were assessed before training , 1 week and 1 month after training : Berg balance scale ( BBS ) , Fullerton advanced balance ( FAB ) scale , functional reach ( FR ) , and timed up and go ( TUG ) . Results The ability to implement the training program was successful . The experimental group significantly increased their BBS and FAB after training while the control group did not . There was no significant change for either groups with FR and TUG . Conclusion A training program using the Kinect with commercially available games was feasible with old adults . Kinect training may be an inexpensive way for old adults to receive helpful feedback encouraging them to continue with balance training program in their home [ Purpose ] The aim of this study was to examine the effects of ball exercise as a general exercise on the balance abilities of elderly individuals by comparing ball exercise with virtual reality exercise . [ Subjects and Methods ] Thirty elderly individuals residing in communities were r and omly divided into a virtual reality game group and a ball exercise group and conducted exercise for 30 min 3 times a week for 8 weeks . [ Results ] Step length increased significantly , and the average sway speed and Timed Up and Go time significantly decreased in both groups . A comparison of sway length after the intervention between the two groups revealed that the virtual reality game exercise result ed in a reduction than the ball exercise . [ Conclusion ] The results of this study indicated that the virtual reality game exercise may improve balance and gait of elderly individuals in communities Frequent or recurrent fallers are more likely to have chronic medical conditions and physiological impairments , exhibit functional decline and have poor outcomes , than single fallers [ 1 ] . Fractures are also more common in recurrent fallers than single fallers [ 2 ] . Modern surgery for hip fracture can no longer improve on its outcomes [ 3 ] and therefore , effective prevention of falls [ 4 , 5 ] is the key to preventing disability and death . There is still no published evidence that a single intervention ( tailored group exercise ) can prevent falls or injuries in a high risk group of frequent fallers . This r and omised controlled trial ( RCT ) aim ed to investigate the impact of a 36 week individualised and tailored group and home exercise intervention , compared with a control intervention , in reducing falls and injuries in communitydwelling , independent-living , frequent falling women aged 65 years and over . Preliminary results have been published in abstract form [ 6 ] . The primary outcome was falls and fallrelated injuries . The secondary outcome was the number of frequent fallers who had died , had moved into residential care or were in hospital compared with the group they were in Background The use of exergaming is a potential alternative to traditional methods of balance training , which can be repetitive and somewhat monotonous . The purpose of this study was to assess the effects of exergaming using XBOX Kinect ™ versus traditional gym-based exercise with no virtual stimuli ( TGB ) on postural control , technology acceptance , flow experience and exercise intensity , in young healthy adults . Methods Fifty healthy active adults ( age : 33.8 ± 12.7 years , height : 172.9 ± 11.9 cm , weight : 75 ± 15.8 kg ) were recruited ; 44 completed both baseline and post-intervention data collection . Participants were r and omised ( blind card ) allocation to one of two groups : ( 1 ) received balance training using the XBOX Kinect ™ and ( 2 ) performed traditional gym-based exercise . Exercises were matched for intensity , duration and movement patterns across groups . All participants completed three , 30-minute , exercise sessions a week for four weeks . Postural sway was measured using a Kistler ™ Force platform during unipedal st and ing . Mean heart rate ( HR ) and rate of perceived exertion ( RPE ) were collected during each exercise session to determine and verify that intensity of exercise was matched between groups . Technology acceptance was measured with the Unified Theory of Acceptance and Use of Technology ( UTAUT ) and flow experience with the Flow State Scale ( FSS ) . Results Heart rate was matched between groups and BORG RPE was significantly lower in the Kinect ™ group . There were significant between-group differences in postural sway in the medial-lateral direction and CoP. There were also significant differences in technology acceptance between groups for performance expectancy , social influence and behavioral intention , with higher values in the Kinect exercise group . The flow state scale showed significant differences between the groups on several dimensions , with higher values in the Kinect exercise group . Conclusion Objective physiological dem and of exercise ( HR ) was matched across groups , but the exergaming group perceived it as being less dem and ing and of lower intensity . This suggests that exergaming may offer an alternative method of rehabilitation exercise through improved concordance . Balance training in healthy adults using the Kinect is both accepted and intrinsically motivating . Trial registration Retrospectively registered on 27th July 2016 . Trial number NCT02851017 Background / Objectives . Balance problems are well-established modifiable risk factors for falls , which are common in older adults . The objective of this study was to establish the efficacy of a Wii-Fit interactive video-game-led physical exercise program to improve balance in older Veterans . Methods . A prospect i ve r and omized controlled parallel-group trial was conducted at Veterans Affairs Medical Center . Thirty community dwelling Veterans aged 68 ( ±6.7 ) years were r and omized to either the exercise or control groups . The exercise group performed Wii-Fit program while the control group performed a computer-based cognitive program for 45 minutes , three days per week for 8-weeks . The primary ( Berg Balance Scale ( BBS ) ) and secondary outcomes ( fear of falling , physical activity enjoyment , and quality of life ) were measured at baseline , 4 weeks , and 8 weeks . Results . Of 30 r and omized subjects , 27 completed all aspects of the study protocol . There were no study -related adverse events . Intent-to-treat analysis showed a significantly greater improvement in BBS in the exercise group ( 6.0 ; 95 % CI , 5.1–6.9 ) compared to the control group ( 0.5 ; 95 % CI , −0.3–1.3 ) at 8 weeks ( average intergroup difference ( 95 % CI ) , 5.5 ( 4.3–6.7 ) , p < 0.001 ) after adjusting for baseline . Conclusion . This study establishes that the Wii-Fit exercise program is efficacious in improving balance in community dwelling older Veterans . This trial is registered with Clinical Trials.gov Identifier NCT02190045 Objective : To compare the effectiveness of three protocol s ( Adapted Physical Activities , Wii Fit ® , Adapted Physical Activities + Wii Fit ® ) on the balance of independent senior subjects . Design : Case comparison study . Setting s : Healthy elderly subjects living in independent community dwellings . Subjects : Thirty-six subjects , average age 75.09 ± 10.26 years , took part in this study , and were r and omly assigned to one of the four experimental groups : G1 followed an Adapted Physical Activities training programme , while the second group ( G2 ) participated in Wii Fit ® training and the third one ( G3 ) combined both methods . There was no training for the fourth group ( G4 ) . All subjects trained once a week ( 1 hour ) for 20 weeks and were assessed before and after treatment . Main measures : The Tinetti test , unipedal tests and the Wii Fit ® tests . Results : After training , the scores in the Tinetti test decreased significantly ( P < 0.05 ) for G1 , G2 and G3 respectively in static conditions and for G1 and G3 in dynamic conditions . After training , the performance in the unipedal tests decreased significantly ( P < 0.05 ) for G1 and G3 . The position of the centre of gravity was modified significantly ( P < 0.05 ) for G2 and G3 . Conclusion : After 20 training sessions , G1 ( Adapted Physical Activities ) , G2 ( Wii Fit ® ) and G3 ( Adapted Physical Activities and Wii Fit ® ) improved their balance . In addition , G1 and G3 increased their dynamic balance . The findings suggest that Adapted Physical Activities training limits the decline in sensorial functions in the elder
Output:
| Exergaming does encourage individuals to st and up ( 3 ) , lean while st and ing ( 4 ) , move upper limbs and turn heads ( 6 ) and dual-task while st and ing ( 9 ) , to some extent move the body forwards , backwards and sideways ( 1 ) , and coordinate movements ( 2 ) but hardly at all to kick , hop , jump or walk ( 7 ) , or to force a postural reaction from a physical force to the individual ( 5 ) and it does not mimic actual changes in sensory context ( 8) .
Some elements of PC are too unsafe to be trained using exergames , such as restricting sensory inputs or applying physical perturbations to an individual to elicit postural responses |
MS210921 | ***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: OBJECTIVES The purpose of this research was to perform a feasibility study of prophylactic coronary revascularization in patients with preoperative extensive stress-induced ischemia . BACKGROUND Prophylactic coronary revascularization in vascular surgery patients with coronary artery disease does not improve postoperative outcome . If a beneficial effect is to be expected , then at least those with extensive coronary artery disease should benefit from this strategy . METHODS One thous and eight hundred eighty patients were screened , and those with > or =3 risk factors underwent cardiac testing using dobutamine echocardiography ( 17-segment model ) or stress nuclear imaging ( 6-wall model ) . Those with extensive stress-induced ischemia ( > or = 5 segments or > or =3 walls ) were r and omly assigned for additional revascularization . All received beta-blockers aim ing at a heart rate of 60 to 65 beats/min , and antiplatelet therapy was continued during surgery . The end points were the composite of all-cause death or myocardial infa rct ion at 30 days and during 1-year follow-up . RESULTS Of 430 high-risk patients , 101 ( 23 % ) showed extensive ischemia and were r and omly assigned to revascularization ( n = 49 ) or no revascularization . Coronary angiography showed 2-vessel disease in 12 ( 24 % ) , 3-vessel disease in 33 ( 67 % ) , and left main in 4 ( 8 % ) . Two patients died after revascularization , but before operation , because of a ruptured aneurysm . Revascularization did not improve 30-day outcome ; the incidence of the composite end point was 43 % versus 33 % ( odds ratio 1.4 , 95 % confidence interval 0.7 to 2.8 ; p = 0.30 ) . Also , no benefit during 1-year follow-up was observed after coronary revascularization ( 49 % vs. 44 % , odds ratio 1.2 , 95 % confidence interval 0.7 to 2.3 ; p = 0.48 ) . CONCLUSIONS In this r and omized pilot study , design ed to obtain efficacy and safety estimates , preoperative coronary revascularization in high-risk patients was not associated with an improved outcome Forty-five patients of ASA physical status 1 and II undergoing a variety of non-cardiac surgical procedures were studied to determine the effect of bolus administration of esmolol , a new short-acting beta blocking drug , on heart rate and blood pressure responses to induction of anaesthesia and tracheal intubation . Subjects were allocated r and omly to receive placebo , 100 mg or 200 mg of esmolol IV as part of an anaesthetic induction technique . The differences in heart rate between the placebo group and both the 100 mg and 200 mg groups were significant prior to intubation ( 95 ± 7.9 , 82 ± 9.7 , 80 ± 7.3 beats per min respectively ) , and also at 0.5 min and 1.5 min following intubation for the 200 mg group . In the 200 mg group there was a significant decrease , compared with placebo , in systolic blood pressure at 0.5 min ( 144 ± 32.1 vs 165 ± 18.7 mmHg ) and 1.5 min ( 154 ± 25.0 vs 170 ± 19.5 mmHg ) after intubation . In this study , adequate haemodynamic control was obtained following administration of 200 mg of esmolol . RésuméQuarante-cinq patients ASA classe I et II devant subir une variété de procédures chirurgicales non-cardiaques ont été étudiés afin de déterminer l’effet de l’administration de l’esmolol en bolus sur la fréquence cardiaque et la tension artérielle lors de l’induction de l’anesthesie et l’intubation endotrachéale . Les sujets ont été r and omisés afin de recevoir soit du placebo , soit 100 mg ou 200 mg d’esmolol lors de l’induction . Les différences dans la fréquence cardiaque entre le groupe placebo et les deux groupes de 100 mg et 200 mg etaient significatives avant l’intubation ( 95 ± 7,9 , 82 ± 9,7 , 80 ± 7,3 battlminute respectivement ) , et aussi à 0,5 minutes et 1,5 minutes après l ’ intubation pour le groupe de 200 mg . Pour le groupe 200 mg , il y avait une diminution significative ( comparativement au placebo ) dans la pression artérielle systolique à 0,5 minutes ( 144 ± 32,1 versus 165 ± 18,7 mmHg ) et à 1,5 minutes ( 154 ± 25,0 versus 170 ± 19,5 mmHg ) après intubation . Dans cette etude , un contrôle hémodynamique adéquat était obtenu aprés administration de 200 mg d’esmolol Background : Carbon dioxide ( CO2 ) pneumoperitoneum for laparoscopic surgery increases arterial pressures , systemic vascular resistance and heart rate and decreases urine output The goal of this study was to compare the efficacy of esmolol and sodium nitroprusside ( SNP ) as primary drugs for producing controlled hypotension and limiting blood loss during orthognathic surgery . Thirty ASA physical status I and II patients ( mean age 22 yr ) undergoing LeFort I maxillary osteotomies were r and omly assigned to receive either esmolol ( n = 15 ) or SNP ( n = 15 ) as the primary drug to induce hypotension . All patients received a balanced anesthetic technique including isoflurane , with controlled hypotension during the down fracture of the maxilla . Patients assigned to the esmolol treatment group received boluses of 500 μg/kg of esmolol , followed by a continuous infusion of 100–300 μkg−1 · min−1 , and the SNP treatment group received a continuous infusion of SNP at 0.25 - -4.00 μkg−1 · min−1 ; both infusions were nitrated to obtain a mean arterial blood pressure within the target range of 55 - -65 mm Hg . The mean arterial blood pressure during the hypotensive period was 58.7 ±0.7 ( mean ± SEM ) and 61.8 ± 0.4 mm Hg for esmolol and SNP , respectively ( P < 0.001 ) . In addition , 40 % ± 4 % of the observed values in the esmolol group and 53 % ± 3 % in the SNP group were outside the target range for mean arterial blood pressure ( difference significant at P < 0.05 ) , and a greater proportion of the deviations were above 65 mm Hg in the SNP group than in the esmolol group ( 0.64 vs 0.46 , respectively , P < 0.05 ) . The mean heart rate was 70 Rekha 3 beats/min ( esmolol ) and 100 ± 3 beats/min ( SNP ) ( P < 0.001 ) , and the mean blood loss was 436 ± 65 mL ( esmolol ) and 895 ± 101 mL ( SNP ) ( P < 0.001 ) . The surgical field was judged to be drier with esmolol than with SNP ( P < 0.05 ) . Plasma renin activity decreased slightly in the esmolol group , whereas in the SNP group it increased 267 % ( P < 0.001 ) . The absence of the renin release may have facilitated the stability of controlled hypotension with esmolol . The advantages of esmolol over SNP for controlled hypotension during orthognathic surgery include greater control of blood pressure , reduction in blood loss , and a drier surgical field . These advantages must be weighed against the possibility of significant myocardial depression produced by intense β1-adrenergic blockade 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 In a double‐blind study the effect of esmolol and alfentanil on the QT interval of the ECG corrected by the heart rate ( QTc ) , heart rate and arterial pressure during anaesthetic induction was studied in 59 oxycodone‐ and atropine‐premedicated ASA class I‐(II ) patients with a mean age of 26 yr ( range 15–50 yr ) . The patients were r and omly allocated to one of the four groups : saline , esmolol 2 mg · kg‐1 , esmolol 3 mg · kg‐1 or alfentanil 0.03 mg·kg‐1 . Both doses of esmolol prevented the prolongation of the QTc interval after thiopental and suxamethonium , but not after laryngoscopy and intubation . Alfentanil prevented the prolongation of the QTc interval following thiopental , suxamethonium and laryngoscopy but not after intubation . Esmolol did not prevent the increase in the heart rate and arterial pressure in response to laryngoscopy and intubation . No cardiovascular responses to laryngoscopy and intubation occurred in the patients treated with alfentanil . No cardiac arrhythmias occurred in the esmolol 3 mg·kg‐1 group , whereas the frequency of ventricular ectopic beats was 40 % in the saline group and 13–20 % m the other groups BACKGROUND Beta-adrenergic agonists enhance behavioural and electroencephalographic arousal reactions . We explored whether adding esmolol , a short-acting beta(1)-adrenoceptor antagonist , to propofol anaesthesia modified the bispectral index ( BIS ) during induction of anaesthesia and orotracheal intubation . METHODS Fifty patients were r and omly allocated , in a double-blind fashion , to receive esmolol 1 mg kg(-1 ) followed by 250 micro g kg(-1 ) min(-1 ) or saline ( control ) . Esmolol or saline was started 6 min after a target-controlled infusion ( TCI ) of propofol ( effect-site concentration 4 micro g ml(-1 ) ) . After loss of consciousness , and before administration of vecuronium 0.1 mg kg(-1 ) , a tourniquet was applied to one arm and inflated to 150 mm Hg greater than systolic pressure . Eleven minutes after the TCI began , the trachea was intubated ; gross movement within the first min after orotracheal intubation was recorded . BIS was recorded at 10-s intervals . Mean arterial pressure ( MAP ) and heart rate
Output:
| Dose titration was shown to influence both the change in arterial blood pressure and heart rate .
: This review suggests that titration of esmolol to a hemodynamic end point can be safe and effective . |
MS210922 | ***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 evaluate the immediate effects of red blood cell transfusion on central venous oxygen saturation and lactate levels in septic shock patients with different transfusion triggers . Methods We included patients with a diagnosis of septic shock within the last 48 hours and hemoglobin levels below 9.0g/dL Patients were r and omized for immediate transfusion with hemoglobin concentrations maintained above 9.0g/dL ( Group Hb9 ) or to withhold transfusion unless hemoglobin felt bellow 7.0g/dL ( Group Hb7 ) . Hemoglobin , lactate , central venous oxygen saturation levels were determined before and one hour after each transfusion . Results We included 46 patients and 74 transfusions . Patients in Group Hb7 had a significant reduction in median lactate from 2.44 ( 2.00 - 3.22 ) mMol/L to 2.21 ( 1.80 - 2.79 ) mMol/L , p = 0.005 , which was not observed in Group Hb9 [ 1.90 ( 1.80 - 2.65 ) mMol/L to 2.00 ( 1.70 - 2.41 ) mMol/L , p = 0.23 ] . Central venous oxygen saturation levels increased in Group Hb7 [ 68.0 ( 64.0 - 72.0)% to 72.0 ( 69.0 - 75.0)% , p < 0.0001 ] but not in Group Hb9 [ 72.0 ( 69.0 - 74.0)% to 72.0 ( 71.0 - 73.0)% , p = 0.98 ] . Patients with elevated lactate or central venous oxygen saturation < 70 % at baseline had a significant increase in these variables , regardless of baseline hemoglobin levels . Patients with normal values did not show a decrease in either group . Conclusion Red blood cell transfusion increased central venous oxygen saturation and decreased lactate levels in patients with hypoperfusion regardless of their baseline hemoglobin levels . Transfusion did not appear to impair these variables in patients without hypoperfusion . Clinical Trials.gov Introduction The aim of this study was to evaluate the effects of red blood cell ( RBC ) transfusions on muscle tissue oxygenation , oxygen metabolism and microvascular reactivity in critically ill patients using near-infrared spectroscopy ( NIRS ) technology . Methods This prospect i ve , observational study included 44 consecutive patients hospitalized in the 31-bed , medical-surgical intensive care unit of a university hospital with anemia requiring red blood cell transfusion . Thenar tissue oxygen saturation ( StO2 ) and muscle tissue hemoglobin index ( THI ) were measured using a tissue spectrometer ( InSpectra ™ Model 325 ; Hutchinson Technology Inc. , Hutchinson , MN , USA ) . A vaso-occlusive test was performed before and 1 hour after RBC transfusion by rapid inflation of a pneumatic cuff around the upper arm . The following variables were recorded : THI , the StO2 desaturation slope during the occlusion ( % /minute ) and the StO2 upslope of the reperfusion phase following the ischemic period ( % /second ) . Muscle oxygen consumption ( NIR VO2 ; arbitrary units ) was calculated as the product of the inverse StO2 desaturation slope and the mean THI over the first minute of arterial occlusion . Results Blood transfusion result ed in increases in hemoglobin ( from 7.1 ( 6.7 to 7.7 ) to 8.4 ( 7.1 to 9 ) g/dl ; P < 0.01 ) and in oxygen delivery ( from 306 ( 259 to 337 ) to 356 ( 332 to 422 ) ml/minute/m2 ; P < 0.001 ) . However , systemic VO2 was unchanged . RBC transfusion did not globally affect NIRS-derived variables , but there was considerable interindividual variation . Changes in the StO2 upslope of the reperfusion phase after transfusion were negatively correlated with baseline StO2 upslope of the reperfusion phase ( r2 = 0.42 ; P < 0.0001 ) . Changes in NIR VO2 after transfusion were also negatively correlated with baseline NIR VO2 ( r2 = 0.48 ; P = 0.0015 ) . There were no correlations between RBC storage time and changes in StO2 slope or NIR VO2 . Conclusions Muscle tissue oxygenation , oxygen consumption and microvascular reactivity are globally unaltered by RBC transfusion in critically ill patients . However , muscle oxygen consumption and microvascular reactivity can improve following transfusion in patients with alterations of these variables at baseline Background Red blood cell ( RBC ) transfusion is commonly used to increase oxygen transport in patients with sepsis . However it does not consistently increase oxygen uptake at either the whole-body level , as calculated by the Fick method , or within individual organs , as assessed by gastric intra-mucosal pH. Aim This study evaluates the hemodynamic and oxygen utilization effects of hemoglobin infusion on critically ill septic patients . Methods Fifteen septic patients undergoing mechanical ventilation whose hemoglobin was < 10 g% were eligible . Ten patients ( APACHE II : 25.5 ± 7.6 ) received an infusion of 1 unit of packed RBC over 1 h while se date d and paralyzed . The remaining five control patients ( APACHE II : 24.3 ± 6.0 ) received a 5 % albumin solution ( 500 ml ) over 1 h. Hemodynamic data , gastric tonometry and calorimetry were obtained prior to and immediately after RBC transfusion or 5 % albumin infusion . Results Transfusion of RBC was associated with an improvement in left ventricular systolic work index ( 38.6 ± 12.6 to 41.1 ± 13.0 g/min/m2 ; P = 0.04 ) . In the control group there was no significant change in the left ventricular systolic work index ( 37.2 ± 14.3 to 42.2 ± 18.9 g/min/m2 ) . An increase in pulmonary vascular resistance index ( 203 ± 58 to 238 ± 49 dyne/cm5/m2 ; P = 0.04 ) was also observed , while no change was produced by colloid infusion ( 237 ± 87.8 to 226.4 ± 57.8 dyne/cm5/m2 ) . Oxygen utilization did not increase either by Fick equation or by indirect calorimetry in either group . Gastric intramucosal pH increased only in the control group but did not reach statistical significance . Conclusion Hemoglobin increase does not improve either global or regional oxygen utilization in anemic septic patients . Furthermore , RBC transfusion may hamper right ventricular ejection by increasing the pulmonary vascular resistance index Background Although the optimum hemoglobin ( H ) concentration for patients with septic shock ( SS ) has not been specifically investigated , current guidelines suggest that H of 7 - 9 g/dL , compared with 10 - 12 g/dL , was not associated with increased mortality in critically ill adults . This contrasts with early goal -directed resuscitation protocol s that use a target hematocrit of 30 % in patients with low central venous oxygen saturation ( ScvO2 ) during the first 6 hours of resuscitation of SS . Methods Data elements were prospect ively collected on all patients with SS patients ( lactic acid ( LA ) > 4 mmol/L , or hypotension ) . Out of a total of 396 SS patients , 46 patients received red blood cell ( RBC ) transfusion for ScvO2 < 70 % ( RBC group ) . We then matched 71 SS patients that did not receive RBC transfusion ( NRBC group ) on the following goals ( G ) : LA obtained within 6 hours ( G1 ) , antibiotics given within 3 hours ( G2 ) , 20 mL/kg fluid bolus followed by vasopressors ( VP ) if needed to keep mean arterial pressure > 65 mm Hg ( G3 ) , central venous pressure > 8 mm Hg within 6 hours ( G4 ) and ScvO2 > 70 % within 6 hours ( G5 ) . Results In the RBC group , after one unit of RBC transfusion , ScvO2 improved from average of 63 % ( ± 12 % ) to 68 % ( ± 10 % ) ( P = 0.02 ) . Sixteen patients required another unit of RBC , and this result ed in increase of ScvO2 to 78 % ( ± 11 % ) ( P < 0.01 ) . The RBC and NRBC groups were matched on sequential organ failure assessment ( SOFA ) scores and all five goals . There was no difference in mortality between the two groups : 41 % vs. 39.4 % ( OR : 0.8 , 95 % CI : 0.4 - 1.7 , P = 0.6 ) . Conclusions In our study , transfusion of RBC was not associated with decreased mortality in SS patients BACKGROUND AND OBJECTIVES Haemoglobin threshold for transfusion has been significantly decreased , but haemoglobin plasma concentration may not be sufficient to assess the need of red-blood-cell ( RBC ) transfusion . Central venous oxygen saturation ( ScvO2 ) is a clue of metabolic matching between O2 transport and consumption , which could help to assess when transfusion is appropriate once anaemia has been diagnosed in ICU patients . MATERIAL S AND METHODS Adult patients admitted consecutively to a cardiothoracic and vascular ICU were included in a prospect i ve , observational and single-centre study over a 6-month period ( September 2014 to February 2015 ) , provided they were transfused with RBC . Patients with active bleeding or in unstable condition were excluded . Haemoglobin and ScvO2 were collected through a central venous catheter before and after transfusion . In order to identify a ScvO2 threshold , analysis of ScvO2 changes after transfusion was performed . RESULTS Fifty-three patients received 100 RBC transfusions . Haemoglobin at the time of transfusion was 7·2 g/dl [ 6·8 - 7·7 ] , while ScvO2 was 66·9 % [ 60 - 73 ] . A 5 % increase in ScvO2 after transfusion has the best specificity and positive predictive values , with a ScvO2 threshold of 65 % . After transfusion ( RBC units , 2 [ 1 - 2 ] ) , ScvO2 increased only in patients with ScvO2 ≤65 % , from 58 % [ 53 - 62 ] to 69 % [ 64 - 73 ] ( P < 0·001 ) . CONCLUSION In anaemic patients , RBC transfusion induced a significant increase in ScvO2 , provided it was low before transfusion . A 65 % cut-off value of ScvO2 before transfusion showed good specificity and good positive predictive value for a 5 % increase after transfusion BACKGROUND Red blood cell transfusion is commonly used to augment systemic oxygen delivery to supranormal levels in patients with sepsis . However , clinical studies have not consistently demonstrated that this therapeutic maneuver is accompanied by an increase in oxygen utilization at either the whole-body level or within individual organs . STUDY OBJECTIVES To determine the effect of red blood cell transfusion on gastrointestinal and whole-body oxygen uptake . DESIGN Prospect i ve , controlled , interventional study . SETTING Multidisciplinary intensive care unit of a tertiary care teaching hospital . PATIENTS Twenty-three critically ill patients with sepsis undergoing mechanical ventilation . MEASUREMENTS AND MAIN RESULTS Systemic oxygen uptake was measured by indirect calorimetry and calculated by the Fick method . Gastric intramucosal pH as measured by tonometry was used to assess changes in splanchnic oxygen availability . Measurements were made prior to transfusion of 3 U of packed red blood cells . These were then repeated immediately following transfusion , as well as 3 and 6 hours later . There was no increase in systemic oxygen uptake measured by indirect calorimetry in any of the patients studied for up to 6 hours posttransfusion ( including those patients with an elevated arterial lactate concentration ) . However , the calculated systemic oxygen uptake increased in parallel with the oxygen delivery in all the patients . More importantly , we found an inverse association between the change in gastric intramucosal pH and the age of the transfused blood ( r = -.71 ; P < .001 ) . In those patients receiving blood that had been stored for more than 15 days , the gastric intramucosal pH consistently decreased following the red blood cell transfusion . CONCLUSION We failed to demonstrate a beneficial effect of red blood cell transfusion on measured systemic oxygen uptake in patients with sepsis . Patients receiving old transfused red blood cells developed evidence of splanchnic ischemia . We postulate that the poorly deformable transfused red blood cells cause micro-circulatory occlusion in some organs , which may lead to tissue ischemia in some organs The role of isolated blood transfusion as a means toward improving oxygen transport was evaluated in 19 critically ill patients having sepsis syndrome as defined by st and ard criteria .
Output:
| Conclusions : Transfusion was not associated with a decrease in mean cardiac output or mean heart rate .
The increase in mean oxygen delivery following transfusion was associated with an increase in mean oxygen consumption after transfusion , especially in patients with sepsis |
MS210923 | ***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 High-mobility group box-1 ( HMGB1 ) is a novel predictor of adverse postinfa rct ion clinical outcomes , playing a crucial role in the appropriate postinfa rct ion healing process . METHODS AND RESULTS Seventy-five postinfa rct ion patients were enrolled in a single-center r and omized study ( clinical trial.gov identifier : NCT00755131 ) . Group T patients ( training , n = 37 ) underwent 6-month exercise-based cardiac rehabilitation ( CR ) program , whereas group C patients ( controls , n = 38 ) were discharged with generic instructions for maintaining physical activity and a correct lifestyle . After 6 months , HMGB1 levels were significantly reduced in the total population ( 26.1 ± 23.5 vs. 16.2 ± 12.9 ng/mL ; P = .0006 ) . After adjusting for several confounders , linear regression analysis showed that the inclusion in the training group ( β = -10.54 , P = .043 ) was associated with marked reduction of HMGB1 levels . After 6 months , HMGB1 levels were significantly lower in trained patients compared to controls ( 11.7 ± 7.0 vs. 20.5 ± 15.6 ng/mL , P = .0027 , respectively ) . In trained patients , decreased HMGB1 levels were significantly associated with the improvement in peak oxygen consumption ( β = -3.879 , P = .003 ) and heart rate recovery ( β = -2.492 , P = .002 ) , and with reduced left ventricular end-diastolic volume ( β = 1.412 , P = .001 ) and wall motion score index ( β = 1.138 , P = .002 ) . CONCLUSIONS The decrease in HMGB1 levels after anterior myocardial infa rct ion was associated with exercise training and with the improvement of cardiopulmonary and autonomic function , and with favorable cardiac remodeling Wu S-K , Lin Y-W , Chen C-L , Tsai S-W : Cardiac rehabilitation vs. home exercise after coronary artery bypass graft surgery : a comparison of heart rate recovery . Am J Phys Med Rehabil 2006;85:711–717 . Objective : The autonomic dysfunction is known to adversely affect clinical outcome in patients with cardiovascular disease , and exercise training has been shown to modify the sympathovagal control of heart rate . The purpose s of this study were to investigate the effect of cardiac rehabilitation on heart rate recovery in patients who received coronary artery bypass grafting ( CABG ) and compare the effect with that of a home-based exercise program . Design : Fifty-four male patients having undergone CABG were r and omly assigned to a cardiac rehabilitation exercise program ( n = 18 ) , a home-based exercise program ( n = 18 ) , and a control group ( n = 18 ) for 12 wks to evaluate the differences in heart rate recovery among groups . Results : Patients in the cardiac rehabilitation group had significant increases in heart rate recovery ( 19.1 ± 6.2 vs. 14.0 ± 5.4 beats/min , P = 0.022 ) compared with those in the control group . There were no significant differences in heart rate recovery between cardiac rehabilitation and home-based exercise groups ( 16.2 ± 4.8 beats/min ) or between home-based exercise and control groups . All three groups had significantly improved heart rate recovery compared with their baseline data ( P < 0.001 , < 0.001 , and 0.007 ) . Conclusion : Our results point out that a cardiac rehabilitation exercise program has a positive effect on heart rate recovery in patients having undergone CABG and is consistent with the autonomic improvement . Although the home-based exercise group did not reveal statistical significance s over those in the control group , it had comparable efficacy to that demonstrated in the cardiac rehabilitation group Heart rate variability ( HRV ) reflects the autonomic tone of the heart , and QT dispersion reflects the regional inhomogeneity of ventricular repolarization . The purpose of the present study was to determine the effects of early exercise training on HRV and QT dispersion in patients with acute myocardial infa rct ion ( AMI ) . Forty patients ( mean age : 59 years ) with AMI were r and omized to training rehabilitation ( group Tr , n=20 ) or conventional rehabilitation ( group C , n=20 ) . Two weeks after AMI , group Tr underwent 10 min of exercise using a bicycle ergometer ( 80 % of anaerobic threshold ) twice a day . At the end of the second and fourth weeks , 12-lead and 24-h Holter ECGs were recorded . QT intervals were measured and corrected using Bazett 's formula ( QTc ) , and QTc dispersion ( QTcd ) was defined as the difference between maximum and minimum QTc . HRV was accessed by the high-frequency component ( HF : 0.15 - 0.40 Hz ) of the HRV power spectrum ( parasympathetic activity ) and the ratio of low frequency ( 0.04 - 0.15 Hz ) to HF ( L/H ratio : sympathetic activity ) . In group Tr , HF increased ( 82.5 to 131.1 ms2 ) , the L/H ratio decreased ( 3.9 to 2.6 ) , and QTcd decreased ( 77.2 to 57.2 ms ) . In group C , none of the indices changed . It was concluded that early exercise training improves sympathovagal balance and decreases QTcd , and may reduce the arrhythmogenic substrate following AMI INTRODUCTION Heart rate recovery , defined as the fall in heart rate during the first minute after exercise , is an indicator of autonomic function , and has been found to be an independent predictor of mortality after acute myocardial infa rct ion . Exercise training has several well-known benefits in terms of cardiorespiratory fitness , modifiable cardiovascular risk factors and prognosis after acute coronary events . However , there are no r and omized controlled studies in the literature evaluating the effects of exercise training per se , controlling for changes in medication and diet , on heart rate recovery . Thus , this study aims to assess the effects of exercise training on autonomic function in coronary artery disease patients recovering from acute myocardial infa rct ion . METHODS Thirty-eight patients following a first acute myocardial infa rct ion participated in this prospect i ve r and omized clinical trial . Patients were r and omized into two groups : exercise training or control . The exercise group participated in an 8-week aerobic exercise program , while the control received st and ard medical care and follow-up . Changes in hemodynamics at rest and at peak exercise ( heart rate , systolic and diastolic blood pressure , and rate pressure product ) , dietary intake , cardiorespiratory fitness , and heart rate recovery were assessed . RESULTS Medication and diet remained unchanged in both groups during the study period . The exercise-training group improved resting hemodynamics , particularly resting heart rate ( from 68.0 ± 9.2 to 62.6 ± 8.7 bpm , p=0.030 ) and systolic blood pressure ( from 135 ± 7.1 to 125.6 ± 11.3 mm Hg , p=0.012 ) , cardiorespiratory fitness ( from 30.8 ± 7.8 to 33.9 ± 8.3 ml/min/kg , p=0.016 ) , and heart rate recovery ( from 20 ± 6 to 24 ± 5 bpm , p=0.007 ) . No significant changes were observed in the control group . CONCLUSIONS Exercise training improved autonomic function , assessed by heart rate recovery , resting heart rate and systolic blood pressure , in the absence of changes in diet or medication OBJECTIVES The aim of this study was to assess the efficacy of exercise and antidepressant medication in reducing depressive symptoms and improving cardiovascular biomarkers in depressed patients with coronary heart disease . BACKGROUND Although there is good evidence that clinical depression is associated with poor prognosis , optimal therapeutic strategies are currently not well defined . METHODS One hundred one out patients with coronary heart disease and elevated depressive symptoms underwent assessment of depression , including a psychiatric interview and the Hamilton Rating Scale for Depression . Participants were r and omized to 4 months of aerobic exercise ( 3 times/week ) , sertraline ( 50 - 200 mg/day ) , or placebo . Additional assessment s of cardiovascular biomarkers included measures of heart rate variability , endothelial function , baroreflex sensitivity , inflammation , and platelet function . RESULTS After 16 weeks , all groups showed improvement on Hamilton Rating Scale for Depression scores . Participants in both the aerobic exercise ( mean -7.5 ; 95 % confidence interval : -9.8 to -5.0 ) and sertraline ( mean -6.1 ; 95 % confidence interval : -8.4 to -3.9 ) groups achieved larger reductions in depressive symptoms compared with those receiving placebo ( mean -4.5 ; 95 % confidence interval : -7.6 to -1.5 ; p = 0.034 ) ; exercise and sertraline were equally effective at reducing depressive symptoms ( p = 0.607 ) . Exercise and medication tended to result in greater improvements in heart rate variability compared with placebo ( p = 0.052 ) ; exercise tended to result in greater improvements in heart rate variability compared with sertraline ( p = 0.093 ) . CONCLUSIONS Both exercise and sertraline result ed in greater reductions in depressive symptoms compared to placebo in patients with coronary heart disease . Evidence that active treatments may also improve cardiovascular biomarkers suggests that they may have a beneficial effect on clinical outcomes as well as on quality of life . ( Exercise to Treat Depression in Individuals With Coronary Heart Disease ; NCT00302068 ) The aim of this study was to evaluate the influence of cardiac rehabilitation ( CR ) on heart rate variability ( HRV ) indices in men with coronary artery disease ( CAD ) treated with percutaneous coronary intervention ( PCI ) or coronary artery bypass graft surgery ( CABG ) . The study population consisted of 131 male patients with CAD prospect ively and consecutively admitted to CR after PCI n = 72 , or CABG n = 59 . Participants performed cycle ergometer interval training for 45 min three times a week for 8 weeks . At baseline and after 8 weeks , all patients underwent the HRV assessment . HRV indices in CAGB survivals were significantly lower in comparison to PCI patients at baseline . Significant increases were seen for SDNN , rMSSD , and HF in the CABG group and only in HF component in PCI group after 8 weeks of CR . Eight weeks of CR seems to be more effective in CABG patients than patients after PCI CONTEXT Observational studies have shown that psychosocial factors are associated with increased risk for cardiovascular morbidity and mortality , but the effects of behavioral interventions on psychosocial and medical end points remain uncertain . OBJECTIVE To determine the effect of 2 behavioral programs , aerobic exercise training and stress management training , with routine medical care on psychosocial functioning and markers of cardiovascular risk . DESIGN , SETTING , AND PATIENTS R and omized controlled trial of 134 patients ( 92 male and 42 female ; aged 40 - 84 years ) with stable ischemic heart disease ( IHD ) and exercise-induced myocardial ischemia . Conducted from January 1999 to February 2003 . INTERVENTIONS Routine medical care ( usual care ) ; usual care plus supervised aerobic exercise training for 35 minutes 3 times per week for 16 weeks ; usual care plus weekly 1.5-hour stress management training for 16 weeks . MAIN OUTCOME MEASURES Self-reported measures of general distress ( General Health Question naire [ GHQ ] ) and depression ( Beck Depression Inventory [ BDI ] ) ; left ventricular ejection fraction ( LVEF ) and wall motion abnormalities ( WMA ) ; flow-mediated dilation ; and cardiac autonomic control ( heart rate variability during deep breathing and baroreflex sensitivity ) . RESULTS Patients in the exercise and stress management groups had lower mean ( SE ) BDI scores ( exercise : 8.2 [ 0.6 ] ; stress management : 8.2 [ 0.6 ] ) vs usual care ( 10.1 [ 0.6 ] ; P = .02 ) ; reduced distress by GHQ scores ( exercise : 56.3 [ 0.9 ] ; stress management : 56.8 [ 0.9 ] ) vs usual care ( 53.6 [ 0.9 ] ; P = .02 ) ; and smaller reductions in LVEF during mental stress testing ( exercise : -0.54 % [ 0.44 % ] ; stress management : -0.34 % [ 0.45 % ] ) vs usual care ( -1.69 % [ 0.46 % ] ; P = .03 ) . Exercise and stress management were associated with lower mean ( SE ) WMA rating scores ( exercise : 0.20 [ 0.07 ] ; stress management : 0.10 [ 0.07 ] ) in a subset of patients with significant stress-induced WMA at baseline vs usual care ( 0.36 [ 0.07 ] ; P = .02 ) . Patients in the exercise and stress management groups had greater mean ( SE ) improvements in flow-mediated d
Output:
| Exercise-based CR improves the post-exercise parasympathetic function , with greater effects in younger CAD patients and in those who were revascularised with percutaneous intervention .
The effects on resting parasympathetic function are more controversial due to method ological inconsistencies in measuring HRV , with the use of RMSSD recommended instead of HF because its results show higher consistency . |
MS210924 | ***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: Results are reported of a double-blind trial to assess the accuracy with which three examiners identified an opaque and a clear fissure sealant . The combined identification error rate for opaque resin was only 1.4 % , whilst for clear resin it was 22.8 % . The difference was highly significant ( P less than 0.0001 ) . Significant differences were also found in the accuracy with which the three dentists identified each type of resin . The most common error was to identify the presence of clear resin on an untreated PURPOSE To evaluate the clinical performance of Helioseal-F , a fluoride-containing fissure sealant , in school children at caries risk . MATERIAL S AND METHODS A caries risk assessment based on past caries experience , saliva microbial tests , buffer capacity and frequency of sugar intake was carried out in 204 healthy children , 6 - 7 years of age . Children exhibiting one or more risk factors were considered at caries risk ( n = 121 ) and their permanent molars were sealed with a fluoride-containing fissure sealant , thus forming a fissure sealant group ( FSG ) . The remaining 83 children with low caries risk received no fissure sealants and constituted a reference group ( RG ) . Both groups were followed for 2 years . From 15 children of both groups , unstimulated whole saliva was collected 1 month after sealant placement in order to determine fluoride levels . In another 20 children , a split-mouth study design was utilized to compare the colonization of mutans streptococci adjacent to and on F-containing sealants and conventional controls . The sealants were placed by dental hygienists according to the manufacturers ' instructions . RESULTS A total of 431 fissure sealants were placed at baseline . Complete retention was found in 76.6 % during the study period while 22.0 % were partially lost . Six sealants ( 1.4 % ) were completely lost . The enamel caries incidence was 45 % lower ( P < 0.05 ) in the permanent molars of the caries risk FSG compared with the low risk RG . There was no significant increase in saliva fluoride concentration following placement of the sealants and the proportion of mutans streptococci in relation to total viable counts was unaffected by type of material . The levels of salivary mutans streptococci were mainly unchanged in both groups during the study period , while the levels of salivary lactobacilli decreased in the FSG PURPOSE The effect of sealants on S. mutans presence in situ was investigated . METHODS Four intact , fully erupted first permanent molars in each of 74 children , aged 6 - 8 years were required for inclusion in the study . Baseline examination included deft and plaque index . S. mutans presence on occlusal surfaces of the molars was evaluated , using a microbial replica method . Immediately after sealing the first permanent molars on one side , S. mutans presence in situ was re-evaluated , as well as three and six months thereafter . Three months after the initiation of the study , S. mutans presence was evaluated on the molars of the unsealed side , which were consequently sealed and re-evaluated immediately , and three months later . RESULTS Positive correlation was found between deft scores , plaque indices and microbial replica values , at baseline . Sealing caused a significant reduction in S. mutans levels on the treated occlusal surfaces , in vivo ( P < 0.001 ) , which lasted , in most cases , up to six months . CONCLUSIONS The data suggest that sealants enable a prolonged reduction of S. mutans presence in situ , indicating an additional prevention effect , by reducing one source of dissemination This study evaluated the outcome of a targeted dental sealant program by comparing the survival probabilities of sealed high-risk first molar tooth sites to unsealed low-risk tooth sites in 1,122 children enrolled in a school-based sealant program . A comparison of the survival probabilities between low-risk first molar teeth that did not receive sealants and the sealed high-risk first molar teeth did not show significant differences . The results suggest that the protocol used by the program provides a satisfactory method for identification of children who could best benefit from sealants in a school-based situation Recent in vitro work and a short clinical study suggest that adding a bonding agent layer between sealant and saliva-contaminated enamel allows for adequate bond strength and retention of resin sealants and may improve success of all sealant applications . This five-year clinical study scored 617 occlusal and 441 buccal/lingual molar sealants , with use of a split-mouth design , with half receiving sealant alone and half bonding agent plus sealant . Treatment effects and potential risk factors for sealant failure were tested by means of a Cox regression model . Three bonding agent groups were analyzed for treatment effect : Tenure primer , Scotchbond Multi- Purpose , and 3 single-bottle dentin bonding agents as a third group . The single-bottle group was successful in reducing risk of sealant failure , with a hazard ratio ( HR ) of 0.53 ( p = 0.014 ) for occlusal and 0.35 ( p = 0.006 ) for buccal/lingual sealants . Scotchbond was detrimental to occlusal sealant success , with a HR of 2.96 ( p = 0.0003 ) . Tenure primer was neutral , showing HRs close to 1.0 . Variables that affected success differed between occlusal and buccal/lingual sealants , suggesting that failures on these two surfaces may be dependent upon differing factors . Early eruption stage was a significant risk factor for both surfaces ( HR = 2.91 , p = 0.00001 , occlusal ; and HR = 1.52 , p = 0.015 , buccal/lingual ) . Behavior ( HR = 1.96 , p = 0.0007 ) , salivary problems ( HR = 1.73 , p = 0.002 ) , and visually apparent variations in enamel ( HR = 1.51 , p = 0.018 ) were significant risk factors for occlusal sealants only . In addition to completing detailed analyses of risk factors for sealant survival , this study shows that single-bottle bonding agents protect sealant survival , yielding half the usual risk of failure for occlusal sealants and one-third the risk of failure for buccal/lingual sealants Following a single application of a chemically polymerized fissure sealant ( Concise Enamel Bond System ) 60 % of the sealants were present after 2 years of examination . The effectiveness of the treatment was highly significant and the caries reduction , irrespective of the sealant status , was found to be about 50 % . The caries reduction was 98 % in sealed pairs where the material was fully retained The half-mouth technique was used to determine the treatment effect of an application of an ultraviolet-light-polymerized sealant . The side of the mouth to be treated with the sealant was r and omly selected . At the one-year examination , a statistically significant reduction in occlusal caries was found for teeth coated with the sealant . Practically no color change or marginal discoloration was evident and retention of the sealant was excellent
Output:
| There is good evidence that sealants can be used efficaciously and effectively in high-risk children as long as the sealant is retained .
Sealants are more effective in preventing further caries and providing cost savings in a shorter time span if placed in children who have high rather than low caries risk |
MS210925 | ***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 investigate the acute effects of long-term whole-body vibration on leg muscle performance and functional capacity in persons with multiple sclerosis . DESIGN A r and omized controlled trial . SUBJECTS Twenty-five patients with multiple sclerosis ( mean age 47.9 ± 1.9 years ; Exp and ed Disability Status Scale 4.3 ± 0.2 ) were assigned r and omly to whole-body vibration training ( n = 11 ) or to a control group ( n = 14 ) . METHODS The whole-body vibration group performed static and dynamic leg squats and lunges on a vibration platform ( 25 - 45 Hz , 2.5 mm amplitude ) during a 20-week training period ( 5 training sessions per 2-week cycle ) , and the control group maintained their usual lifestyle . PRE- , MID- ( 10 weeks ) and POST- ( 20 weeks ) knee-muscle maximal isometric and dynamic strength , strength endurance and speed of movement were measured using isokinetic dynamometry . Function was determined through the Berg Balance Scale , Timed Up and Go , Two-minute Walk Test and the Timed 25-Foot Walk Test . RESULTS Leg muscle performance and functional capacity were not altered following 10 or 20 weeks of whole-body vibration . CONCLUSION Under the conditions of the present study , the applied 20-week whole-body vibration exercise protocol did not improve leg muscle performance or functional capacity in mild- to moderately impaired persons with multiple sclerosis during and immediately after the training programme The effects of hard squatting exercise with ( VbX+ ) and without ( VbX− ) vibration on neuromuscular function were tested in 19 healthy young volunteers . Before and after the exercise , three different tests were performed : maximum serial jumping for 30 s , electromyography during isometric knee extension at 70 % of the maximum voluntary torque , and the quantitative analysis of the patellar tendon reflex . Between VbX+ and VbX− values , there was no difference found under baseline conditions . Time to exhaustion was significantly shorter in VbX+ than in VbX− ( 349 ± 338 s versus 515 ± 338 s ) , but blood lactate ( 5·49 ± 2·73 mmol l−1 versus 5·00 ± 2·26 mmol l−1 ) and subjectively perceived exertion ( rate of perceived exertion values 18·1 ± 1·2 versus 18·6 ± 1·6 ) at the termination of exercise indicate comparable levels of fatigue . After the exercise , comparable effects were observed on jump height , ground contact time , and isometric torque . The vastus lateralis mean frequency during isometric torque , however , was higher after VbX+ than after VbX−. Likewise , the tendon reflex amplitude was significantly greater after VbX+ than after VbX− ( 4·34 ± 3·63 Nm versus 1·68 ± 1·32 Nm ) . It is followed that in exercise unto comparable degrees of exhaustion and muscular fatigue , superimposed 26 Hz vibration appears to elicit an alteration in neuromuscular recruitment patterns , which apparently enhance neuromuscular excitability . Possibly , this effect may be exploited for the design of future training regimes Objective : To examine whether a whole-body vibration ( mechanical oscillations ) in comparison to a placebo administration leads to better postural control , mobility and balance in patients with multiple sclerosis . Design : Double-blind , r and omized controlled trial . Setting : Outpatient clinic of a university department of physical medicine and rehabilitation . Subjects : Twelve multiple sclerosis patients with moderate disability ( Kurtzke 's Exp and ed Disability Status Scale 2.5 - 5 ) were allocated either to the intervention group or to the placebo group . Interventions : In the intervention group a whole-body vibration at low frequency ( 2.0 - 4.4 Hz oscillations at 3-mm amplitude ) in five series of 1 min each with a 1-min break between the series was applied . In the placebo group a Burst-transcutaneous electrical nerve stimulation ( TENS ) application on the nondominant forearm in five series of 1 min each with a 1-min break between the series was applied as well . Main outcome measures : Posturographic assessment using the Sensory Organization Test , the Timed Get Up and Go Test and the Functional Reach Test immediately preceding the application , 15 min , one week and two weeks after the application . The statistical analysis was applied to the change score from preapplication values to values 15 min , one week and two weeks post intervention . Results : Compared with the placebo group the intervention group showed advantages in terms of the Sensory Organization Test and the Timed Get Up and Go Test at each time point of measurement after the application . The effects were strongest one week after the intervention , where significant differences for the change score ( p=0.041 ) were found for the Timed Get Up and Go Test with the mean score reducing from 9.2 s ( preapplication ) to 8.2 s one week after whole-body vibration and increasing from 9.5 s ( preapplication ) to 10.2 s one week after placebo application . The mean values of the posturographic assessment increased from 70.5 points ( preapplication ) to 77.5 points one week after whole body vibration and increased only from 67.2 points ( preapplication ) to 67.5 points one week after the placebo application . No differences were found for the Functional Reach Test . Conclusion : The results of this pilot study indicated that whole-body vibration may positively influence the postural control and mobility in multiple sclerosis patients PURPOSE The aim of this study was to investigate and to compare the effect of a 12-wk period of whole-body vibration training and resistance training on human knee-extensor strength . METHODS Sixty-seven untrained females ( 21.4 + /- 1.8 yr ) participated in the study . The whole-body vibration group ( WBV , N = 18 ) and the placebo group ( PL , N = 19 ) performed static and dynamic knee-extensor exercises on a vibration platform . The acceleration of the vibration platform was between 2.28 g and 5.09 g , whereas only 0.4 g for the PL condition . Vibration ( 35 - 40 Hz ) result ed in increased EMG activity , but the EMG signal remained unchanged in the PL condition . The resistance-training group ( RES , N = 18 ) trained knee extensors by dynamic leg-press and leg-extension exercises ( 10 - 20 RM ) . All training groups exercised 3x wk-1 . The control group ( CO , N = 12 ) did not participate in any training . Pre- and postisometric , dynamic , and ballistic knee-extensor strength were measured by means of a motor-driven dynamometer . Explosive strength was determined by means of a counter-movement jump . RESULTS Isometric and dynamic knee-extensor strength increased significantly ( P < 0.001 ) in both the WBV group ( 16.6 + /- 10.8 % ; 9.0 + /- 3.2 % ) and the RES group ( 14.4 + /- 5.3 % ; 7.0 + /- 6.2 % ) , respectively , whereas the PL and CO group showed no significant ( P > 0.05 ) increase . Counter-movement jump height enhanced significantly ( P < 0.001 ) in the WBV group ( 7.6 + /- 4.3 % ) only . There was no effect of any of the interventions on maximal speed of movement , as measured by means of ballistic tests . CONCLUSIONS WBV , and the reflexive muscle contraction it provokes , has the potential to induce strength gain in knee extensors of previously untrained females to the same extent as resistance training at moderate intensity . It was clearly shown that strength increases after WBV training are not attributable to a placebo effect The aim of this study was to investigate the effects of vibration exercise on postural steadiness performance in a healthy , older population . Forty-three healthy , older participants ( 23 men and 20 women , aged 73.5+/-4.5 yr ) were r and omly assigned to either a vibration group ( VIB ) , an exercise without vibration group ( EX ) or a control group ( CONT ) . The VIB and EX groups undertook static and dynamic bodyweight exercises three times per week for eight weeks . Static balance was assessed using a one-legged postural steadiness ( OLPS ) test . This test was performed prior to and immediately after the training period . OLPS improved significantly for the VIB intervention after eight weeks training ( p<0.05 ) compared to the EX and CONT groups . The improvements in OLPS were significantly affected by the baseline values , with the largest changes evident for VIB participants with a poorer initial score ( p<0.01 ) . Vibration exercise can contribute to improved static one-legged balance in a healthy , older population . As improvements in OLPS were related to baseline values , vibration exercise as an intervention would appear to serve the most benefit for those that exhibit diminished postural control OBJECTIVE To investigate the effects of whole body vibration ( WBV ) training on gait function in persons with mild multiple sclerosis ( MS ) . DESIGN A r and omized controlled trial . SUBJECTS 18 patients with MS were assigned r and omly to WBV ( intervention group ) or to placebo WBV . METHODS Both groups performed a 3-week training period under static conditions on a vibration platform . In the placebo group , the vibration platform was covered and therefore vibrations could not operate . Gait function ( gait velocity , stride length , double support phase , single-step variability left and right ) was assessed at baseline , after 3-weeks of WBV intervention or sham WBV , 4-weeks after baseline , and 5-weeks after baseline using a mobile plantar food pressure system and the " Timed Up and Go " test under four different gait conditions ( comfortable overground gait , comfortable gait on treadmill , -20 % comfortable gait velocity on treadmill and + 20 % comfortable gait velocity on treadmill ) . RESULTS None of the outcome measures of gait function showed statistically significant alterations following 3-weeks of intervention/placebo WBV . CONCLUSION The applied protocol of WBV does not show a meaningful improvement of gait function in mildly affected MS patients
Output:
| These results indicate that the WBV may improve the knee extension muscle strength .
However , the WBV does not show a meaningful improvement of functional mobility in MS patients |
MS210926 | ***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 effect of a neuromuscular training program on the incidence of anterior cruciate ligament injuries in female team h and ball players . Design Prospect i ve intervention study . Setting Female team h and ball : Division I – III in Norway . Participants Players from the three top divisions : control season ( 1998–1999 ) , 60 teams ( 942 players ) ; first intervention season ( 1999–2000 ) , 58 teams ( 855 players ) ; second intervention season ( 2000–2001 ) , 52 teams ( 850 players ) . InterventionA five-phase program ( duration , 15 min ) with three different balance exercises focusing on neuromuscular control and planting/l and ing skills was developed and introduced to the players in the autumn of 1999 and revised before the start of the season in 2000 . The teams were instructed in the program and supplied with an instructional video , poster , six balance mats , and six wobble boards . Additionally , a physical therapist was attached to each team to follow up with the intervention program during the second intervention period . Main Outcome Measures The number of anterior cruciate ligament injuries during the three seasons and compliance with the program . Results There were 29 anterior cruciate ligament injuries during the control season , 23 injuries during the first intervention season ( OR , 0.87 ; CI , 0.50–1.52 ; p = 0.62 ) , and 17 injuries during the second intervention season ( OR , 0.64 ; CI , 0.35–1.18 ; p = 0.15 ) . In the elite division , there were 13 injuries during the control season , six injuries during the first intervention season ( OR , 0.51 ; CI , 0.19–1.35 ; p = 0.17 ) , and five injuries in the second intervention season ( OR , 0.37 ; CI , 0.13–1.05 ; p = 0.06 ) . For the entire cohort , there was no difference in injury rates during the second intervention season between those who complied and those who did not comply ( OR , 0.52 ; CI , 0.15–1.82 ; p = 0.31 ) . In the elite division , the risk of injury was reduced among those who completed the anterior cruciate ligament injury prevention program ( OR , 0.06 ; CI , 0.01–0.54 ; p = 0.01 ) compared with those who did not . Conclusions This study shows that it is possible to prevent anterior cruciate ligament injuries with specific neuromuscular training Background This study was conducted to investigate whether the most common injuries in soccer could be prevented , and to determine if a simple question naire could identify players at increased risk . Hypothesis Introduction of targeted exercise programs to male soccer players with a history of previous injury or reduced function in the ankle , knee , hamstring , or groin will prevent injuries . Study Design R and omized controlled trial ; Level of evidence , 2 . Methods A total of 508 players representing 31 teams were included in the study . A question naire indicating previous injury and /or reduced function as inclusion criteria was used to divide the players into high-risk ( HR ) ( 76 % ) and low-risk ( LR ) groups . The HR players were r and omized individually into an HR intervention group or HR control group . Results A total of 505 injuries were reported , sustained by 56 % of the players . The total injury incidence was a mean of 3.2 ( 95 % confidence interval [ CI ] , 2.5–3.9 ) in the LR control group , 5.3 ( 95 % Cl , 4.6–6.0 ) in the HR control group ( P = .0001 vs the LR control group ) , and 4.9 ( 95 % Cl , 4.3–5.6 ) in the HR intervention group ( P = .50 vs the HR control group ) . For the main outcome measure , the sum of injuries to the ankle , knee , hamstring , and groin , there was also a significantly lower injury risk in the LR control group compared with the 2 other groups , but no difference between the HR intervention group and the HR control group . Compliance with the training programs in the HR intervention group was poor , with only 27.5 % in the ankle group , 29.2 % in the knee group , 21.1 % in the hamstring group , and 19.4 % in the groin defined as having carried out the minimum recommended training volume . Conclusion The players with a significantly increased risk of injury were able to be identified through the use of a question naire , but player compliance with the training programs prescribed was low and any effect of the intervention on injury risk could not be detected To study the efficacy of an injury prevention program in a r and omized trial , 12 teams ( 180 players ) in a male senior soccer division were followed up for 6 months . The 12 teams were allocated at r and om to two groups of six teams , one being given a prophylactic program and the other serving as control . The program was based on previous studies of injury mechanisms . It comprised ( 1 ) correction of training , ( 2 ) provision of optimum equipment ; ( 3 ) prophylactic ankle taping ; ( 4 ) controlled rehabilitation ; ( 5 ) exclusion of players with grave knee instability ; ( 6 ) information about the impor tance of disciplined play and the increased risk of injury at training camps ; and ( 7 ) correction and supervision by doctor(s ) and physiotherapist(s ) . The injuries in the test teams were 75 % fewer than in the controls . The most common types of soccer injuries , sprains and strains to ankles and knees , were all significantly reduced . It is concluded that the pro posed prophylactic program , including close supervi sion and correction by doctors and physiotherapists , significantly reduces soccer injuries Abstract . This prospect i ve r and omized intervention investigated whether training on a balance board could reduce the amount of traumatic injuries of the lower extremities in female soccer players . A total of 221 female soccer players from 13 different teams playing in the second and third Swedish divisions volunteered to participate in the study . Seven teams ( n=121 ) were r and omized to an intervention group and six teams ( n=100 ) to a control group and were followed during one outdoor season ( April – October ) . Before and after the season muscle flexibility and balance/postural sway of the lower extremities were measured in the players . There were no significant differences in age , height , weight , muscle flexibility and balance/postural sway of the lower extremities between the intervention and the control group . During the season the players in the intervention group performed a special training program consisting of 10–15 min of balance board training in addition to their st and ard soccer practice and games . After a 37 % drop-out the intervention group consisted of 62 players and the control group of 78 players . The results showed no significant differences between the groups with respect either to the number , incidence , or type of traumatic injuries of the lower extremities . The incidence rate of " major " injuries was higher in the intervention group than in the control group . Four of five anterior cruciate ligament injuries occurred in the intervention group , which means that we could not prevent severe knee injuries in female soccer players with balance board training . However , among the players who had been injured during the 3-month period prior to this investigation there were significantly more players from the control group than from the intervention group who sustained new injuries during the study period Objective To evaluate the effectiveness of neuromuscular training in reducing the rate of acute knee injury in adolescent female football players . Design Stratified cluster r and omised controlled trial with clubs as the unit of r and omisation . Setting 230 Swedish football clubs ( 121 in the intervention group , 109 in the control group ) were followed for one season ( 2009 , seven months ) . Participants 4564 players aged 12 - 17 years ( 2479 in the intervention group , 2085 in the control group ) completed the study . Intervention 15 minute neuromuscular warm-up programme ( targeting core stability , balance , and proper knee alignment ) to be carried out twice a week throughout the season . Main outcome measures The primary outcome was rate of anterior cruciate ligament injury ; secondary outcomes were rates of severe knee injury ( > 4 weeks ’ absence ) and any acute knee injury . Results Seven players ( 0.28 % ) in the intervention group , and 14 ( 0.67 % ) in the control group had an anterior cruciate ligament injury . By Cox regression analysis according to intention to treat , a 64 % reduction in the rate of anterior cruciate ligament injury was seen in the intervention group ( rate ratio 0.36 , 95 % confidence interval 0.15 to 0.85 ) . The absolute rate difference was −0.07 ( 95 % confidence interval −0.13 to 0.001 ) per 1000 playing hours in favour of the intervention group . No significant rate reductions were seen for secondary outcomes . Conclusions A neuromuscular warm-up programme significantly reduced the rate of anterior cruciate ligament injury in adolescent female football players . However , the absolute rate difference did not reach statistical significance , possibly owing to the small number of events . Trial registration Clinical trials NCT00894595 Young female players in European h and ball have a very high injury incidence , up to 50 injuries per 1000 hours of game . More than half of these injuries happen without any external cause . The aim of the study was to investigate the effect of an intervention programme design ed to reduce the number of injuries in young female players in European h and ball , with special emphasis on injuries in the lower extremities . The programme was created using elite athlete training programmes and those design ed for rehabilitation of injured athletes with functional instability of their ankles and rupture of the anterior cruciate ligament . It included the use of an ankle disk for 10 - 15 min at all practice sessions , for one 10-month season ( August 1995-May 1996 ) . Twenty-two teams participated in the study , and were r and omly assigned to the intervention or control group . Eleven teams with 111 players were r and omised to the intervention group and 11 teams with 126 players to the control group . Data were analysed using a t-test for continuous variables , chi2- analysis and Fisher 's exact test for dichotomous variables and multivariate methods to determine odds-ratios . The results indicated that using the intervention programme decreased the numbers of both traumatic and overuse injuries significantly . The differences in injuries between the groups were 80 % during games and 71 % during practice . In addition , the players in the control group had a 5.9 times higher risk of acquiring an injury than the players in the intervention group Background The incidence rate of soccer injuries is among the highest in sports , particularly for adult male soccer players . Purpose To investigate the effect of the ‘ The11 ’ injury prevention programme on injury incidence and injury severity in adult male amateur soccer players . Study design Cluster-r and omised controlled trial . Methods Teams from two high-level amateur soccer competitions were r and omly assigned to an intervention ( n=11 teams , 223 players ) or control group ( n=12 teams , 233 players ) . The intervention group was instructed to perform The11 in each practice session during one soccer season . The11 focuses on core stability , eccentric training of thigh muscles , proprioceptive training , dynamic stabilisation and plyometrics with straight leg alignment . All participants of the control group continued their practice sessions as usual . Results In total , 427 injuries were recorded , affecting 274 of 456 players ( 60.1 % ) . Compliance with the intervention programme was good ( team compliance=73 % , player compliance=71 % ) . Contrary to the hypothesis , injury incidences were almost equal between the two study groups : 9.6 per 1000 sports hours ( 8.4–11.0 ) for the intervention group and 9.7 ( 8.5–11.1 ) for the control group . No significant differences were found in injury severity , but a significant difference was observed in the location of the injuries : players in the intervention group sustained significantly less knee injuries . Conclusions This study did not find significant differences in the overall injury incidence or injury severity between the intervention and control group of adult male soccer players . More research is recommended , focusing on injury aetiology and risk factors in adult male amateur soccer players To prospect ively evaluate the effect of neuromuscular training on the incidence of knee injury in female athletes , we monitored two groups of female athletes , one trained before sports participation and the other not trained , and a group of untrained male athletes throughout the high school soccer , volleyball , and basketball seasons . Weekly reports included the number of practice and competition exposures and mechanism of injury . There were 14 serious knee injuries in the 1263 athletes tracked through the study . Ten of 463 untrained female athletes sustained serious knee injuries ( 8 noncontact ) , 2 of 366 trained female athletes sustained serious knee injuries ( 0 noncontact ) , and 2 of 434 male athletes sustained serious knee injuries ( 1 noncontact ) . The knee injury incidence per 1000 athlete-exposures was 0.43 in untrained female athletes , 0.12 in trained female athletes , and 0.09 in male athletes ( P 0.02 , chi-square analysis ) . Untrained female athletes had a 3.6 times higher incidence of knee injury than trained female athletes ( P 0.05 ) and 4.8 times higher than male athletes ( P 0.03 ) . The incidence of knee injury in trained female athletes was not significantly different from that in untrained male athletes ( P 0.86 ) . The difference in the incidence of noncontact injuries between the female groups was also significant ( P 0
Output:
| Conclusion : This systematic review and meta- analysis of ACL and knee injury prevention program studies found a statistically significant reduction in injury risk for knee injuries but did not find a statistically significant reduction of ACL injuries |
MS210927 | ***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 number of vegetables have a high nitrate content which after ingestion can be reduced to nitrite by oral bacteria , and further to vasoprotective NO endogenously . In the present study , two separate r and omly controlled , single-blind , cross-over , postpr and ial studies were performed in normotensive volunteers . Ambulatory blood pressure ( BP ) was measured over a 24 h period following consumption of either four doses of beetroot juice ( BJ ) , 0 , 100 , 250 and 500 g ( n 18 ) , or three bread products , control bread ( 0 g beetroot ) , red beetroot- and white beetroot-enriched breads ( n 14 ) . Total urinary nitrate/nitrite ( NO(x ) ) was measured at baseline , and at 2 , 4 and 24 h post-ingestion . BJ consumption significantly , and in a near dose-dependent manner , lowered systolic BP ( SBP , P < 0·01 ) and diastolic BP ( DBP , P < 0·001 ) over a period of 24 h , compared with water control . Furthermore , bread products enriched with 100 g red or white beetroot lowered SBP and DBP over a period of 24 h ( red beetroot-enriched bread , P < 0·05 ) , with no statistical differences between the varieties . Total urinary NO(x ) significantly increased following the consumption of 100 g ( P < 0·01 ) , 250 g ( P < 0·001 ) and 500 g BJ ( P < 0·001 ) and after red beetroot-enriched bread ingestion ( P < 0·05 ) , but did not reach significance for white beetroot-enriched bread compared with the no-beetroot condition . These studies demonstrated significant hypotensive effects of a low dose ( 100 g ) of beetroot which was unaffected by processing or the presence of betacyanins . These data strengthen the evidence for cardioprotective BP-lowering effects of dietary nitrate-rich vegetables Background The consumption of beetroot juice on a low nitrate diet may lower blood pressure ( BP ) and therefore reduce the risk of cardiovascular events . However , it is unknown if its inclusion as part of a normal diet has a similar effect on BP . The aim of the study was to conduct a r and omized controlled trial with free-living adults to investigate if consuming beetroot juice in addition to a normal diet produces a measureable reduction in BP . Method Fifteen women and fifteen men participated in a double-blind , r and omized , placebo-controlled , crossover study . Volunteers were r and omized to receive 500 g of beetroot and apple juice ( BJ ) or a placebo juice ( PL ) . Volunteers had BP measured at baseline and at least hourly for 24-h following juice consumption using an ambulatory blood pressure monitor ( ABPM ) . Volunteers remained at the clinic for 1-h before resuming normal non-strenuous daily activities . The identical procedure was repeated 2-wk later with the drink ( BJ or PL ) not consumed on the first visit . Results Overall , there was a trend ( P=0.064 ) to lower systolic blood pressure ( SBP ) at 6-h after drinking BJ relative to PL . Analysis in men only ( n=13 ) after adjustment for baseline differences demonstrated a significant ( P<0.05 ) reduction in SBP of 4 – 5 mmHg at 6-h after drinking BJ . Conclusions Beetroot juice will lower BP in men when consumed as part of a normal diet in free-living healthy adults . Trial registration anzctr.org.au Use of the DASH ( Dietary Approaches to Stop Hypertension ) diet , which is rich in fruits , vegetables , and low-fat dairy foods , significantly lowers blood pressure . Among the 459 participants in the DASH Trial , 72 had stage 1 isolated systolic hypertension ( ISH ) ( systolic blood pressure , 140 to 159 mm Hg ; diastolic blood pressure , < 90 mm Hg ) . We examined the blood pressure response in these 72 participants to determine whether the DASH diet is an effective treatment for stage 1 ISH . After a 3-week run-in period on a typical American ( control ) diet , participants were r and omly assigned for 8 weeks to 1 of 3 diets : a continuation of the control diet ( n=25 ) , a diet rich in fruits and vegetables ( n=24 ) , or the DASH diet ( n=23 ) . Sodium content was the same in the 3 diets , and caloric intake was adjusted during the trial to prevent weight change . Blood pressure was measured at baseline and at the end of the 8-week intervention period with st and ard sphygmomanometry . Use of the DASH diet significantly lowered systolic blood pressure compared with the control diet ( −11.2 mm Hg ; 95 % confidence interval , −6.1 to −16.2 mm Hg;P < 0.001 ) and the fruits/vegetables diet ( −8.0 mm Hg ; 95 % confidence interval , −2.5 to −13.4 mm Hg;P < 0.01 ) . Overall , blood pressure in the DASH group fell from 146/85 to 134/82 mm Hg . Similar results were observed with 24-hour ambulatory blood pressure measurements . In the DASH diet group , 18 of 23 participants ( 78 % ) reduced their systolic blood pressure to < 140 mm Hg , compared with 24 % and 50 % in the control and fruits/vegetables groups , respectively . Our results indicate that the DASH diet , which is rich in fruits , vegetables , and low-fat dairy foods , is effective as first-line therapy in stage 1 ISH The mechanism underlying blood pressure ( BP ) reduction in the high fruits and vegetables arm of the Dietary Approaches to Stop Hypertension ( DASH ) study is unknown but may include potassium , magnesium and fibre . This study was design ed to separate minerals and fibre from other components of DASH on BP in abdominally obese individuals with metabolic syndrome with pre-hypertension to stage 1 hypertension ( obese hypertensives ) . A total of 15 obese hypertensives and 15 lean normotensives were studied on a st and ardized usual diet , r and omized to DASH or usual diet supplemented with potassium , magnesium and fibre to match DASH , then crossed over to the complementary diet . All diets were 3 weeks long , isocaloric and matched for sodium and calcium . In obese hypertensives , BP was lower after 3 weeks on DASH than usual diet ( −7.6±1.4/−5.3±1.4 mm Hg , P<0.001/0.02 ) and usual diet supplemented ( −6.2±1.4/−3.7±1.4 P<0.005/0.06 ) , whereas BP was not significantly different on usual and supplemented diets . BP values were not different among the three diets in lean normotensives . Small artery elasticity was lower in obese hypertensives than in lean normotensives on the usual and supplemented diets ( P<0.02 ) . This index of endothelial function improved in obese hypertensives ( P<0.02 ) but not lean normotensives on DASH , and was no longer different from values in lean normotensives ( P>0.50 ) . DASH is more effective than potassium , magnesium and fibre supplements for lowering BP in obese hypertensives , which suggest that high fruits and vegetables DASH lowers BP and improves endothelial function in this group by nutritional factors in addition to potassium , magnesium and fibre 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 anion nitrate-abundant in our diet-has recently emerged as a major pool of nitric oxide ( NO ) synthase-independent NO production . Nitrate is reduced stepwise in vivo to nitrite and then NO and possibly other bioactive nitrogen oxides . This reductive pathway is enhanced during low oxygen tension and acidosis . A recent study shows a reduction in oxygen consumption during submaximal exercise attributable to dietary nitrate . We went on to study the effects of dietary nitrate on various physiological and biochemical parameters during maximal exercise . Nine healthy , nonsmoking volunteers ( age 30+/-2.3 years , VO(2max ) 3.72+/-0.33 L/min ) participated in this study , which had a r and omized , double-blind crossover design . Subjects received dietary supplementation with sodium nitrate ( 0.1 mmol/kg/day ) or placebo ( NaCl ) for 2 days before the test . This dose corresponds to the amount found in 100 - 300 g of a nitrate-rich vegetable such as spinach or beetroot . The maximal exercise tests consisted of an incremental exercise to exhaustion with combined arm and leg cranking on two separate ergometers . Dietary nitrate reduced VO(2max ) from 3.72+/-0.33 to 3.62+/-0.31 L/min , P<0.05 . Despite the reduction in VO(2max ) the time to exhaustion trended to an increase after nitrate supplementation ( 524+/-31 vs 563+/-30 s , P=0.13 ) . There was a correlation between the change in time to exhaustion and the change in VO(2max ) ( R(2)=0.47 , P=0.04 ) . A moderate dietary dose of nitrate significantly reduces VO(2max ) during maximal exercise using a large active muscle mass . This reduction occurred with a trend toward increased time to exhaustion implying that two separate mechanisms are involved : one that reduces VO(2max ) and another that improves the energetic function of the working muscles Six days of dietary nitrate supplementation in the form of beetroot juice ( ~0.5 L/d ) has been reported to reduce pulmonary oxygen uptake ( VO₂ ) during submaximal exercise and increase tolerance of high-intensity work rates , suggesting that nitrate can be a potent ergogenic aid . Limited data are available regarding the effect of nitrate ingestion on athletic performance , and no study has investigated the potential ergogenic effects of a small-volume , concentrated dose of beetroot juice . The authors tested the hypothesis that 6 d of nitrate ingestion would improve time-trial performance in trained cyclists . Using a double-blind , repeated- measures crossover design , 12 male cyclists ( 31±3 yr , VO2peak=58±2 ml·kg⁻¹·min⁻¹ , maximal power [Wmax]=342±10 W ) ingested 140 ml/d of concentrated beetroot ( ~8 mmol/d nitrate ) juice ( BEET ) or a placebo ( nitrate-depleted beetroot juice ; PLAC ) for 6 d , separated by a 14-d washout . After supplementation on Day 6 , subjects performed 60 min of submaximal cycling ( 2 × 30 min at 45 % and 65 % Wmax , respectively ) , followed by a 10-km time trial . Time-trial performance ( 953±18 vs. 965±18 s , p<.005 ) and power output ( 294±12 vs. 288±12 W , p<.05 ) improved after BEET compared with PLAC supplementation . Submaximal VO₂ was lower after BEET ( 45 % Wmax=1.92±0.06 vs. 2.02±0.09 L/min , 65 % Wmax 2.94±0.12 vs. 3.11±0.12 L/min ) than with PLAC ( main effect , p<.05 ) . Whole-body fuel selection and plasma lactate , glucose , and insulin concentrations did not differ between treatments . Six days of nitrate supplementation reduced VO₂ during submaximal exercise and improved time-trial performance in trained cyclists PURPOSE Dietary nitrate supplementation has been shown to reduce the O2 cost of submaximal exercise and to improve high-intensity exercise tolerance . However , it is presently unknown whether it may enhance performance during simulated competition . The present study investigated the effects of acute dietary nitrate supplementation on power output ( PO ) , VO2 , and performance during 4- and 16.1-km cycling time trials ( TT ) . METHODS After familiarization , nine club-level competitive male cyclists were assigned in a r and omized , crossover design to consume 0.5 L of beetroot juice ( BR ; containing ∼ 6.2 mmol of nitrate ) or 0.5 L of nitrate-depleted BR ( placebo , PL ; containing ∼ 0.0047 mmol of nitrate ) , ∼ 2.5 h before the completion of a 4- and a 16.1-km TT . RESULTS BR supplementation elevated plasma [ nitrite ] ( PL = 241 ± 125 vs BR = 575 ± 199 nM , P < 0.05 ) . The VO2 values during the TT were not significantly different between the BR and PL conditions at any elapsed distance ( P > 0.05 ) , but BR significantly increased mean PO during the 4-km ( PL = 279 ± 5
Output:
| Inorganic nitrate and beetroot juice supplementation was associated with a significant reduction in systolic BP . |
MS210928 | ***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 To estimate the effect of adding exercise classes , spinal manipulation delivered in NHS or private premises , or manipulation followed by exercise to “ best care ” in general practice for patients consulting with back pain . Fig 1 Progress of the UK BEAM trial Design Pragmatic r and omised trial with factorial design . Setting 181 general practice s in Medical Research Council General Practice Research Framework ; 63 community setting s around 14 centres across the United Kingdom . Participants 1334 patients consulting their general practice s about low back pain . Main outcome measures Scores on the Rol and Morris disability question naire at three and 12 months , adjusted for centre and baseline scores . Results All groups improved over time . Exercise improved mean disability question naire scores at three months by 1.4 ( 95 % confidence interval 0.6 to 2.1 ) more than “ best care . ” For manipulation the additional improvement was 1.6 ( 0.8 to 2.3 ) at three months and 1.0 ( 0.2 to 1.8 ) at 12 months . For manipulation followed by exercise the additional improvement was 1.9 ( 1.2 to 2.6 ) at three months and 1.3 ( 0.5 to 2.1 ) at 12 months . No significant differences in outcome occurred between manipulation in NHS premises and in private premises . No serious adverse events occurred . Conclusions Relative to “ best care ” in general practice , manipulation followed by exercise achieved a moderate benefit at three months and a small benefit at 12 months ; spinal manipulation achieved a small to moderate benefit at three months and a small benefit at 12 months ; and exercise achieved a small benefit at three months but not 12 months This study examined the supplemental value of a cognitive coping skills training when added to an operant-behavioral treatment for chronic low-back pain patients . The complete treatment package ( OPCO ) was compared with an operant program + group discussion ( OPDI ) and a waiting-list control ( WLC ) . After the WL period , the WLC patients received a less protocol ized operant program usually provided in Dutch rehabilitation centers ( OPUS ) . Regression analyses showed that , compared with WLC , both OPCO and OPDI led to less negative affect , higher activity tolerance , less pain behavior , and higher pain coping and pain control . At posttreatment , OPCO led to better pain coping and pain control than OPDI . Calculation of improvement rates revealed that OPCO and OPDI had significantly more improved patients than OPUS on all the dependent variables . The discussion includes findings regarding treatment credibility , compliance , and contamination bias Study Design . A prospect i ve clinical trial was conducted that involved six groups of patients with chronic low back pain selected from a large cohort ( N = 816 ) . Objectives . To correlate pretreatment baseline variables with outcome parameters after treatment in a functional restoration program or in control programs , to identify possible factors predictive of the need for functional restoration . Summary of Background Data . Since the functional restoration program was first described , research has focused on identifying patients who will or will not benefit from such a program . The value of previous studies is limited , however , because predictive factors from a control group were not " subtracted . " Methods . Eight hundred sixteen patients with chronic low back disability were included . All had a structured medical examination , including various physical tests before participation in either a functional restoration program ( n = 621 ) or shorter " control " outpatient programs ( n = 144 ) . A smaller group of the cohort ( n = 51 ) had no treatment and served as a pure control group . Six groups were selected from the cohort : Three underwent an identical functional restoration program and three underwent different outpatient control programs . Several baseline demographic , physical , and socioeconomic variables were correlated to 1‐year outcome parameters . Results . Age , days of sick leave , connection to the work force , and back pain intensity , were significantly correlated to success 1 year after entry into the study in all groups , no matter what kind of treatment was administered . Back muscle endurance , sports activity , activity of daily living scores , and vibrations were of importance in some outcome parameters for success after functional restoration . Smoking was positively correlated to disability pension . Days of sick leave and , in functional restoration , ability to work were the only factors that were correlative with statistics for people who withdrew . Conclusions . Different factors can be identified as predictive of outcome in a functional restoration program , but most of these factors were also shown to predict success for shorter control outpatient programs or of no treatment Introduction The Multinational Musculoskeletal Inception Cohort Study ( MMICS ) Statement is a consensus statement aim ed at improving the quality of prospect i ve investigations into the transition from early stages of low back pain ( LBP ) to persistent problems . The statement aims to help improve the quality of such studies by recommending an agreed minimal list of measures for inclusion in baseline data collection . The MMICS Statement is primarily aim ed at research ers who want to investigate prognosis in LBP , and this will allow data from cohorts to be pooled and will facilitate comparisons between different health care systems . One approach to preventing acute new episodes of LBP ( up to 3 weeks from onset ) from developing into persistent disabling pain is to identify those individuals with LBP who are most likely to progress to chronic disability . Targeting interventions at those at highest risk could reduce the population burden of chronic LBP . A wide range of baseline parameters have been associated with poor outcome in inception cohort studies ( 1–6 ) . Few existing studies have been of sufficient size and method ologic rigor to produce conclusive findings . Even in method ologically robust studies , baseline factors only account for a small proportion of the variance in outcome ( 7 ) , typically around 30 % . Systematic review s of the literature could not pool data because studies used different measurements ( 1–3 ) . Despite some information on physical , psychosocial , and work-related risk factors , it has not been possible to adequately estimate the comparative impact of individual psychosocial and societal factors on the transition from acute to persistent disabling LBP . How to address this problem was one focus of the VI International Forum for Primary Care Research in Low Back Pain held in April 2003 . A steering group for the collaboration was appointed , and 8 national team leaders volunteered to recruit teams of national experts . Three additional team leaders were recruited by the steering group ( Australia , France , and Germany ) . Independent experts were invited to advise on the quality of the MMICS process . The MMICS steering group , located in the UK , met regularly and included expert research ers in clinical and outcome factors in back pain ( AB ) , work-related issues in back pain ( AKB ) , psychosocial aspects of back pain ( TP and RS ) , and general practice aspects of back pain ( MU ) . The MMICS Statement set out to include 1 ) a minimal but comprehensive number of predictor factors based on current evidence and theory ; 2 ) appropriate measurement instruments for agreed predictor factors based on their clinometric properties , availability , and practical characteristics ; and 3 ) a minimum set of followup measures , including recommendations about measurement and timing Objective To determine the effectiveness of lessons in the Alex and er technique , massage therapy , and advice from a doctor to take exercise ( exercise prescription ) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain . Design Factorial r and omised trial . Setting 64 general practice s in Engl and . Participants 579 patients with chronic or recurrent low back pain ; 144 were r and omised to normal care , 147 to massage , 144 to six Alex and er technique lessons , and 144 to 24 Alex and er technique lessons ; half of each of these groups were r and omised to exercise prescription . Interventions Normal care ( control ) , six sessions of massage , six or 24 lessons on the Alex and er technique , and prescription for exercise from a doctor with nurse delivered behavioural counselling . Main outcome measures Rol and Morris disability score ( number of activities impaired by pain ) and number of days in pain . Results Exercise and lessons in the Alex and er technique , but not massage , remained effective at one year ( compared with control Rol and disability score 8.1 : massage −0.58 , 95 % confidence interval −1.94 to 0.77 , six lessons −1.40 , −2.77 to −0.03 , 24 lessons −3.4 , −4.76 to −2.03 , and exercise −1.29 , −2.25 to −0.34 ) . Exercise after six lessons achieved 72 % of the effect of 24 lessons alone ( Rol and disability score −2.98 and −4.14 , respectively ) . Number of days with back pain in the past four weeks was lower after lessons ( compared with control median 21 days : 24 lessons −18 , six lessons −10 , massage −7 ) and quality of life improved significantly . No significant harms were reported . Conclusions One to one lessons in the Alex and er technique from registered teachers have long term benefits for patients with chronic back pain . Six lessons followed by exercise prescription were nearly as effective as 24 lessons . Trial registration National Research Register N0028108728 . How does the Alex and er Technique work ? What are the authors findings about the clinical and cost effectiveness of the treatment ? Watch this video to find out ( 12 mins ) . Many manual therapists assess and treat spinal stiffness of people with low back pain . The objectives of this study were to investigate : ( i ) whether spinal stiffness changes after treatment ; ( ii ) the relationship between pre-treatment spinal stiffness and change in stiffness with treatment ; ( iii ) the relationship between spinal stiffness , pain , disability and global perceived effect of treatment ; ( iv ) whether spinal stiffness predicts outcome of treatment or response to treatment in chronic low back pain patients . One hundred and ninety-one subjects with chronic low back pain were r and omly allocated to groups that received either spinal manipulative therapy , motor control exercise , or a general exercise program . Spinal stiffness was assessed before and after intervention . All three groups showed a significant decrease in stiffness following treatment ( p<0.001 ) . No difference between groups was observed . There was a significant negative correlation between pre-treatment stiffness and change in stiffness ( r=-0.61 ; p<0.001 ) . There was a significant but weak correlation ( r=0.18 ; p=0.02 ) between change in stiffness and change in global perceived effect of treatment , and a significant but weak correlation between change in stiffness and change in function for subjects in the spinal manipulative therapy group ( r=-0.28 ; p=0.02 ) . No significant association was observed between initial stiffness score and any of the final outcome measures following treatment . Initial stiffness did not predict response to any treatment . In conclusion , spinal stiffness decreases over the course of an episode of treatment , more so in those with the stiffest spines , but the decrease is not dependent on treatment and is not generally related to outcome Background Current method ological guidelines provide advice about the assessment of sub-group analysis within RCTs , but do not specify explicit criteria for assessment . Our objective was to provide research ers with a set of criteria that will facilitate the grading of evidence for moderators , in systematic review s. Method We developed a set of criteria from method ological manuscripts ( n = 18 ) using snowballing technique , and electronic data base search es . Criteria were review ed by an international Delphi panel ( n = 21 ) , comprising authors who have published method ological papers in this area , and research ers who have been active in the study of sub-group analysis in RCTs . We used the Research ANd Development/University of California Los Angeles appropriateness method to assess consensus on the quantitative data . Free responses were coded for consensus and disagreement . In a subsequent round additional criteria were extracted from the Cochrane Review ers ' H and book , and the process was repeated . Results The recommendations are that meta-analysts report both confirmatory and exploratory findings for sub-groups analysis . Confirmatory findings must only come from studies in which a specific theory/ evidence based a-priori statement is made . Exploratory findings may be used to inform future/subsequent trials . However , for inclusion in the meta- analysis of moderators , the following additional criteria should be applied to each study : Baseline factors should be measured prior to r and omisation , measurement of baseline factors should be of adequate reliability and validity , and a specific test of the interaction between baseline factors and interventions must be presented . Conclusions There is consensus from a group of 21 international experts that method ological criteria to assess moderators within systematic review s of RCTs is both timely and necessary . The consensus from the experts result ed in five criteria divided into two groups when synthesis ing evidence : confirmatory findings to support hypotheses about moderators and exploratory findings to inform future research . These recommendations are discussed in reference to previous recommendations for evaluating and reporting moderator studies Background The treatment of non-specific chronic low back pain is often based on three different models regarding the development and maintenance of pain and especially functional limitations : the deconditioning model , the cognitive behavioral model and the biopsychosocial model . There is evidence that rehabilitation of patients with chronic low back pain is more effective than no treatment , but information is lacking about the differential effectiveness of different kinds of rehabilitation . A direct comparison of a physical , a cognitive-behavioral treatment and a combination of both has never been carried out so far . Methods The effectiveness of active physical , cognitive-behavioral and combined treatment for chronic non-specific low back pain compared with a waiting list control group was determined by performing a r and omized controlled trial in three rehabilitation centers . Two hundred and twenty three patients were r and omized , using concealed block r and omization to one of the following treatments , which they attended three times a week for 10 weeks : Active Physical Treatment ( APT ) , Cognitive-Behavioral Treatment ( CBT ) , Combined Treatment of APT and CBT ( CT ) , or Waiting List ( WL ) . The outcome variables were self-reported functional limitations , patient 's main complaints , pain , mood , self-rated treatment effectiveness , treatment satisfaction and physical performance including walking , st and ing up , reaching forward , stair climbing and lifting . Assessment s were carried out by blinded research assistants at baseline and immediately post
Output:
| Subgroup analyses performed in NSLBP trials have been severely underpowered , are only able to provide exploratory or insufficient findings , and have rather poor quality of reporting . |
MS210929 | ***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: IL-10 is considered a potent antiinflammatory cytokine that strongly inhibits the production of proinflammatory cytokines . Recent studies have suggested that IL-10 also has immunostimulatory properties on CD4 + , CD8 + T cells , and /or NK cells , result ing in increased IFN-γ production . To determine the effect of IL-10 on IFN-γ production and related inflammatory responses in humans , 16 healthy subjects received a bolus i.v . injection of LPS ( 4 ng/kg ) in combination with either placebo or recombinant human IL-10 ( 25 μg/kg ) , administered just before or 1 h after LPS . IL-10 treatment , particularly when administered after LPS , enhanced LPS-induced IFN-γ release , as well as the release of the IFN-γ-dependent chemokines IFN-γ-inducible protein-10 and monokine induced by IFN-γ , while inhibiting or not influencing the production of IFN-γ-inducing cytokines . In addition , IL-10 treatment enhanced activation of CTLs and NK cells after LPS injection , as reflected by increased levels of soluble granzymes . These data indicate that high-dose IL-10 treatment in patients with inflammatory disorders can be associated with undesired proinflammatory effects Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items Objective —The goal of this study was to examine the association of the antiinflammatory interleukin-10 ( IL-10 ) with risk of cardiovascular disease ( CVD ) . Methods and Results —In the PROSPER ( PROspect i ve Study of Pravastatin in the Elderly at Risk ) cohort , we related baseline concentrations of circulating IL-10 to risk of CVD events in a nested case (n=819)-control ( n=1618 ) study of 3.2 years of follow-up . Circulating IL-10 showed few strong associations with classical risk factors but was positively correlated with IL-6 and C-reactive protein . IL-10 was positively associated with risk of CVD events ( odds ratio [ OR ] 1.17 , 95 % CI 1.05 to 1.31 per unit increase in log IL-10 ) after adjusting for classical risk factors and C-reactive protein . Furthermore , IL-10 was associated more strongly with CVD risk among those with no previous history of CVD ( OR 1.42 , 95 % CI 1.18 to 1.70 ) , compared with those with previous CVD ( OR 1.04 , 95 % CI 0.90 to 1.19 ; P=0.018 ) . Overall , IL-10 showed a modest ability to add discrimination to classical risk factors ( C-statistic + 0.005 , P=0.002 ) . Conclusion —Baseline circulating levels of the antiinflammatory IL-10 are positively associated with risk of CVD among the elderly without prior CVD events , although the association is less evident in those with a history of CVD . Additional epidemiological and mechanistic studies investigating the role of IL-10 in CVD are warranted OBJECTIVES The goal of this study was to determine the predictive value of pregnancy-associated plasma protein-A ( PAPP-A ) in patients with acute coronary syndromes ( ACS ) . BACKGROUND Pregnancy-associated plasma protein-A is a zinc-binding matrix metalloproteinase abundantly expressed in eroded and ruptured plaques and may serve as a marker of plaque destabilization . METHODS In 547 patients with angiographically vali date d ACS and in a heterogeneous emergency room population of 644 patients with acute chest pain , respectively , PAPP-A as well as markers of myocardial necrosis ( troponin T [ TnT ] ) , ischemia ( vascular endothelial growth factor [ VEGF ] ) , inflammation ( high-sensitivity C-reactive protein [ hsCRP ] ) , anti-inflammatory activity ( interleukin [IL]-10 ) , and platelet activation ( soluble CD40 lig and [ sCD40L ] ) were determined . Patients were followed for the occurrence of death or myocardial infa rct ion . RESULTS In patients with ACS , elevated PAPP-A levels ( > 12.6 mIU/l ) indicated an increased risk ( odds ratio 2.44 [ 95 % confidence interval ( CI ) 1.43 to 4.15 ] ; p = 0.001 ) . When the analysis was restricted to TnT-negative patients , PAPP-A still identified a subgroup of high-risk patients ( odds ratio [ OR ] 2.72 [ 95 % confidence interval ( CI ) 1.25 to 5.89 ] ; p = 0.009 ) . In a multivariable model , PAPP-A ( OR 2.01 ; p = 0.015 ) , sCD40L ( OR 2.37 ; p = 0.003 ) , IL-10 ( OR 0.43 ; p = 0.003 ) , and VEGF ( OR 2.19 ; p = 0.018 ) were independent predictors . Prospect i ve validation in patients with chest pain confirmed that PAPP-A levels reliably identify high-risk patients ( adjusted OR 2.32 [ 95 % CI 1.32
Output:
| The pooled relative risks for both studies reporting the risk estimates by IL-10 categories and studies reporting the risk estimates by unit IL-10 indicated an association between high IL-10 levels and adverse events .
Sensitivity and subgroup analysis indicated that the results obtained in IL-10 categories were not stable .
Data from our meta- analysis supported the existence of a relationship between high serum IL-10 levels and adverse events in patients with ACS . |
MS210930 | ***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 safety and efficacy of oxybutynin transdermal delivery system ( oxybutynin-TDS ) versus placebo in adults with urge and mixed urinary incontinence was investigated using combined results from double-blind stages of 2 phase3 clinical trials . Study 1 : placebo-controlled , parallel-group comparison of 3 oxybutynin – TDS doses in 12-week double-blind and open-label periods , followed by a 28-week open-label extension . Study 2 was a 12-week r and omized , double-blind , placebo-controlled comparison of oxybutynin-TDS versus long-acting tolterodine and placebo , followed by a 52-week open-label extension . Efficacy analysis included 241 patients receiving oxybutynin-TDS , 244 receiving placebo . Most participants were Caucasian women ( 92 % ) . Approximately 60 % received prior anticholinergic therapy . Primary outcome was determined by changes from baseline to end of treatment in frequency of incontinence episodes , frequency of urination , and void volume . Oxybutynin-TDS was significantly more effective than placebo in reducing median daily incontinence episodes ( −3.0 vs placebo −2.0 ; P=.00004 ) and daily urinary frequency ( −2.0 vs −1.0 ; P=.0023 ) , and in increasing void volume ( 25 mL vs 5.5 mL ; P<.00001 ) . Overall rates of anticholinergic adverse events ( AEs ) were 12.8 % for oxybutynin-TDS and 11.0 % for placebo ( P=0.5421 ) . The most common systemic anticholinergic AEs were dry mouth ( 7.0 % for oxybutynin-TDS vs 5.3 % for placebo ) and constipation ( 2.1 % vs 2.0 % ) . Application site erythema occurred in 7.0 % of participants who received oxybutynin-TDS ( 3.7 % discontinuation rate ) ; pruritus occurred in 16.1 % ( 3.3 % discontinuation rate ) . Transdermal oxybutynin was shown to be efficacious , with a proven safety profile . It may be utilized for patients with overactive bladder as a treatment option that could enhance compliance OBJECTIVES To compare the efficacy and safety of an oxybutynin transdermal delivery system ( OXY-TDS ) and oral , long-acting tolterodine ( TOL-LA ) with placebo in previously treated patients with urge or mixed urinary incontinence . METHODS After withdrawal of their current antimuscarinic therapy , 361 adult patients were r and omized to 12 weeks of double-blind , double-dummy treatment with twice weekly OXY-TDS 3.9 mg/day , daily TOL-LA 4 mg , or placebo . Evaluations included change from baseline in patient urinary diary symptoms , incontinence-specific quality of life , and safety . RESULTS OXY-TDS 3.9 mg/day and TOL-LA 4 mg/day significantly reduced the number of daily incontinence episodes ( median change -3 OXY-TDS and -3 TOL-LA versus -2 placebo ; P < 0.05 ) , increased the average void volume ( median change 24 and 29 mL versus 5.5 mL , P < 0.01 ) , and improved quality of life ( incontinence impact question naire [ IIQ ] total score , P < 0.05 ; Urogenital Distress Inventory Irritative Symptom subscale , P < 0.05 ) compared with placebo . The most common adverse event for OXY-TDS was localized application site pruritus ( 14 % versus 4 % placebo ) accompanied by a low incidence of systemic side effects ( eg , dry mouth 4.1 % ) . Anticholinergic adverse events occurred with greatest frequency during TOL-LA treatment ( dry mouth 7.3 % versus 1.7 % placebo , P < 0.05 ) . CONCLUSIONS OXY-TDS and TOL-LA are effective and comparable treatments for patients with urge and mixed incontinence . OXY-TDS improves systemic safety with regard to anticholinergic side effects . Local skin irritation occurs in some OXY-TDS patients OBJECTIVE The objective of the study was to determine the impact of overactive bladder on sexual function from a preliminary analysis of the Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin study . STUDY DESIGN The Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin study was an open-label , prospect i ve trial of 2878 subjects with overactive bladder , treated with transdermal oxybutynin for 6 months or less . The impact of overactive bladder on sexual function before and after treatment was assessed via item responses from the King 's Health Question naire and Beck Depression Inventory-II ( kappa-test ) . RESULTS At baseline , 586 ( 23.1 % ) reported that overactive bladder had an impact on their sex life . Coital incontinence in 569 ( 22.8 % ) decreased after treatment to 438 ( 19.3 % ) . Effects of overactive bladder on subjects ' sex lives improved in 19.1 % ( worsened in 11.2 % ) , and the effect on relationships with partners improved in 19.6 % ( worsened in 11.9 % ) . Reduced interest in sex , reported by 52.1 % at baseline , improved significantly . ( all P < .0001 ) . CONCLUSION Overactive bladder negatively affects sexual function . Treatment with transdermal oxybutynin improved sexual function and marital relationships PURPOSE We evaluated the efficacy and safety of an oxybutynin transdermal delivery system ( TDS ) in a general population of patients with overactive bladder and urge or mixed urinary incontinence . MATERIAL S AND METHODS Following symptom stabilization or treatment withdrawal 520 adult patients were r and omized to 12 weeks of double-blind daily treatment with 1.3 , 2.6 or 3.9 mg . oxybutynin TDS or placebo administered twice weekly , followed by a 12-week open-label , dose titration period to assess efficacy and safety further . Evaluations included patient urinary diaries , incontinence specific quality of life and safety . RESULTS A dose of 3.9 mg . daily oxybutynin TDS significantly reduced the number of weekly incontinence episodes ( median change -19.0 versus -14.5 , p = 0.0165 ) , reduced average daily urinary frequency ( mean change -2.3 versus -1.7 , p = 0.0457 ) , increased average voided volume ( median change 24 versus 6 ml . , p = 0.0063 ) and significantly improved quality of life ( Incontinence Impact Question naire total score , p = 0.0327 ) compared with placebo . Average voided volume increased in the daily 2.6 mg . group ( 19 ml . , p = 0.0157 ) but there were no other significant differences between 1.3 and 2.6 mg . oxybutynin TDS and placebo . The most common adverse event was application site pruritus ( oxybutynin TDS 10.8 % to 16.8 % , placebo 6.1 % ) . Dry mouth incidence was similar in both groups ( 7.0 % versus 8.3 % , p not significant ) . In the open-label period a sustained reduction of nearly 3 incontinence episodes per day was reported for all groups . CONCLUSIONS Doses of 2.6 and 3.9 mg . oxybutynin TDS daily improve overactive bladder symptoms and quality of life , and are well tolerated . Transdermal oxybutynin is an innovative new treatment for overactive bladder BACKGROUND AND OBJECTIVE Oxybutynin is a common antimuscarinic therapy for overactive bladder . Transdermally administered oxybutynin chloride topical gel 10 % ( OTG ) has a low propensity for anticholinergic adverse effects and possibly also a low risk of cognitive impairment . A r and omized , double-blind , placebo- and active-controlled study evaluated the effects of OTG on cognitive and psychomotor functions in older healthy adults . METHODS Healthy adults aged 60 - 79 years were assigned r and omly ( 1:1:1 ) to 1-week 's treatment with OTG ( 1 g [ 100 mg oxybutynin ] applied once daily on rotating sites of upper arms/shoulders , abdomen or thighs ) plus oral placebo , immediate-release oxybutynin ( OXB-IR ; 5 mg capsule three times/day ) plus placebo gel , or double placebo . Delayed recall Name-Face Association Test ( NFAT ) score was the primary end point . Treatments were compared by analysis of covariance . RESULTS Of 152 participants ( mean age , 68 years ) , 49 received OTG , 52 OXB-IR and 51 placebo . NFAT Delayed Recall tests revealed no significant treatment differences ( overall , p = 0.2733 ; OTG vs placebo , p = 0.1551 ; OXB-IR vs placebo , p = 0.1767 ) . However , a significant effect ( p = 0.0294 ) was noted for the Misplaced Objects Test , with scores declining only for OXB-IR . Approximately twice as many participants receiving OXB-IR ( n = 10 ) as those receiving OTG ( n = 5 ) or placebo ( n = 6 ) showed a significant decline ( ≥6 points ) in Total Recall score for the Hopkins Verbal Learning Test-Revised . No significant effects on psychomotor reaction time were observed . The most common adverse event , dry mouth , occurred in 6.1 % , 73.1 % and 7.8 % of participants receiving OTG , OXB-IR and placebo , respectively . CONCLUSIONS OTG applied for 1 week had no clinical ly meaningful effect on recent memory or other cognitive functions in healthy , older adults . CLINICAL TRIAL REGISTRATION Registered as NCT00752141 at www . clinical trials.gov PURPOSE We compared the short-term efficacy , safety and tolerability of transdermal versus oral oxybutynin in adults with urge urinary incontinence . MATERIAL S AND METHODS Volunteers with detrusor instability currently responding to oral immediate release oxybutynin were enrolled in our study . Those patients presenting with recurrence of incontinent symptoms after a 2-week washout underwent confirmatory cystometrogram with subsequent r and omization to transdermal or oral treatment . Matching active and placebo medications included matrix patches applied twice weekly and capsules taken 2 or 3 times daily . Dose titration was based on anticholinergic symptoms . Outcome measures included comparison of baseline to 6 week changes in incontinence episodes on a 3 day urinary diary , a visual analog scale for efficacy and anticholinergic symptoms reported on a question naire . Safety monitoring included adverse events and skin tolerability of the transdermal system . RESULTS A total of 76 patients were enrolled and 74 completed at least 4 weeks of treatment . Mean age in the transdermal and oral groups was 64 and 63 years , and 87 % and 97 % were female , respectively . Daily incontinent episodes decreased in the transdermal and oral groups ( 7.3 to 2.4 [ 66 % ] and 7.4 to 2.6 [ 72 % ] , respectively , p = 0.39 ) . The visual analog scale reduction in urinary leakage improved from washout in both groups ( p < 0.0001 ) with no difference between them ( p = 0.9 ) . Dry mouth occurred in significantly fewer patients in the transdermal ( 38 % ) compared with those in the oral group ( 94 % , p < 0.001 ) . Of the patients in the transdermal group 67 % noticed a reduction in dry mouth severity compared with previous oral treatment , and 90 % had none or mild skin erythema . CONCLUSIONS Transdermal delivery of oxybutynin result ed in comparable efficacy and a significantly improved anticholinergic side effect profile compared with oral administration in adults with urge urinary incontinence
Output:
| RESULTS The evaluated studies show that patients treated with OXY-TDS experience a significant reduction in urinary incontinence episodes compared with placebo , which is comparable to that observed in patients treated with oral oxybutynin or with tolterodine .
The clinical practice study also showed improved quality of life , achieving benefits in numerous patient profiles , with an efficacy independent of previous treatments .
The safety of the drug was demonstrated in the various patient profiles .
OXY-TDS represents an effective alternative for the symptomatic treatment of adult patients with OAB , which , thanks to its pharmacokinetic profile , better tolerability , different administration method and dosage , could represent an added value in treating special population |
MS210931 | ***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 Background : Giant prosthetic reinforcement of the visceral sac ( GPRVS ) , an open preperitoneal mesh repair , is a very effective groin hernia repair . Laparoscopic transabdominal preperitoneal repair ( TAPP ) , based on the same principle , is expected to combine low recurrence rates with minimal postoperation morbidity . Methods : Seventy-nine patients with 93 recurrent and 15 concomitant primary inguinal hernias were r and omized between GPRVS ( 37 patients ) and TAPP ( 42 patients ) . Operating time , complications , pain , analgesia use , disability period , and recurrences were recorded . Results : Mean operating time was 56 min with GPRVS versus 79 min with TAPP ( p < 0.001 ) . Most complications were minor , except for a pulmonary embolus and an ileus , both after GPRVS . Patients experienced less pain after a laparoscopic repair . Average disability period was 23 days with GPRVS versus 13 days with TAPP ( p= 0.03 ) for work , and 29 versus 21 days , respectively ( p= 0.07 ) for physical activities . Recurrence rates at a mean follow-up of 34 months were 1 in 52 ( 1.9 % ) for GPRVS versus 7 in 56 ( 12.5 % ) for TAPP ( p= 0.04 ) . Hospital costs in U.S. dollars were comparable , with GPRVS at $ 1,150 and TAPP at $ 1,179 . Conclusions : Laparoscopic repair of recurrent inguinal hernia has a lower morbidity than GPRVS . However , laparoscopic repair is a difficult operation , and the potential technical failure rate is higher . With regard to recurrence rates , the open preperitoneal prosthetic mesh repair remains the best repair OBJECTIVE To compare outcome and costs between laparoscopic and open hernia repair . DESIGN Prospect i ve r and omised study . SETTING One university and two district hospitals in Sweden . SUBJECTS 200 men aged 25 - 75 years . MAIN OUTCOME MEASURES Operating time , hospital stay , complications , and time to recovery . A cost-minimisation- analysis was used in which the total costs were calculated for a defined period of time for each option . RESULT The one year follow-up rate was 98 % . Mean ( SD ) operation times in the laparoscopic and open groups were 72 ( 30 ) and 62 ( 25 ) minutes , respectively ( p = 0.009 ) . Hospital stay and complication rates did not differ between the groups . Among employees the mean ( SD ) periods off work in the laparoscopic and open groups were 10 ( 8) and 23 ( 21 ) days , respectively ( p = 0.0001 ) . The mean direct costs of the laparoscopic operation were increased by SEK 4037 ( US$ 483 ) but the savings in indirect costs result ing from earlier return to work were SEK 11392 ( US$ 1364 ) . CONCLUSIONS Laparoscopic hernia repair gave the employed patients faster recovery and return to work , and was the most cost-effective strategy provided that both direct and indirect costs were included BACKGROUND Benefits of laparoscopic herniorrhaphy ( LH ) over open hernia repair ( OH ) remain unproved . METHODS Interim analysis of a prospect i ve r and omized controlled trial compared OH with LH where study outcomes were measured by third-party evaluators through patient interviews . RESULTS Both groups were well matched for all baseline parameters , although LH patients anticipated a quicker postoperative recovery than OH ( p = 0.014 ) . No significant difference was noted in operating time or surgeon operative satisfaction . The median duration of hospital stay was 1 day in both groups ; LH patients made use of significantly less postoperative narcotics than OH ( p = 0.02 ) . No difference was observed in the duration s of convalescence ( LH , 9.6 + /- 7.6 days ; OH , 10.9 + /- 7.4 days ) . Greater improvements in quality of life were exhibited in LH patients than OH patients 1 month after operation ( p = 0.035 ) , with one of the two measures used . A greater percentage of LH patients seemed " very satisfied with their operation " ( p = 0.07 ) . Complication rates were similar , and a single recurrence , in a patient in the OH group , has been observed after a median follow-up of 14 months . CONCLUSIONS Direct cost measurements showed LH to be 40 % more expensive than OH in the context of a Canadian-type health care system . To date , benefits in postoperative pain and possibly quality of life have been detected in the LH group Abstract Background : In February 1993 a prospect i ve r and omized multicenter trial was initiated to compare laparoscopic transabdominal preperitoneal hernioplasty to Shouldice herniorrhaphy as performed by surgeons of nonspecialized clinics . Methods : Until January 1994 , 87 patients with 108 hernias took part in the trial ( 43 Shouldice and 44 laparoscopic repairs ) . Results : The laparoscopic procedure took significantly longer than did the open operation but caused less pain as measured by pain analogue score and consumption of paracetamol and narcotics . The postoperative complication rate was 26 % in the open and 16 % in the laparoscopic group . The patients in the laparoscopic group were discharged earlier and their convalescence was shorter than after open hernia repair . There has been one early recurrence in the laparoscopic and two in the open group to date with a mean follow-up of 201 days . Conclusions : Laparoscopic hernia repair causes less pain than the conventional operation and enables the patient to return to full work and usual activities earlier . The recurrence rate will not be known for 5 years Abstract Background : Laparoscopic herniorrhaphy is controversial and deserves critical evaluation . Methods : In a r and omized prospect i ve study transabdominal preperitoneal laparoscopic herniorrhaphy ( n= 24 ) was compared in patients to the tension-free Lichtenstein repair ( n= 29 ) utilizing vali date d and reliable pain and activity assessment tools . The Sickness Impact Profile ( SIP ) was used to compare preoperative normal activity to postoperative activity . A Pain-O-Meter ( visual analogue scale plus affective and sensory pain descriptors ) assessed intensity of pain . The total pain assessment score and SIP were compared across time ( postoperative day 1–42 ) . Analgesic medication was used as a covariate . Results : The total pain score was less for laparoscopic herniorrhaphy but this did not reach statistical significance . Similarly , the SIP showed modest improvement for laparoscopic herniorrhaphy . No differences between groups were noted for morphine equivalents of administered analgesics or length of hospitalization . Conclusion : Further investigation of laparoscopic herniorrhaphy is warranted A prospect i ve study of 242 patients with inguinal hernia who underwent tension‐free mesh repair by the laparoscopic transperitoneal ( n = 121 ) or the open Lichtenstein ( n = 121 ) technique was performed . There was no significant difference in operation time between the laparoscopic ( median ( range ) 35 ( 20–90 ) min ) and Lichtenstein ( 40 ( 20–90 ) min ) procedures . Discharge within 24 h of operation was more common after laparoscopic surgery ( 89·3 per cent versus 48·7 per cent ) . Consequently , hospital stay was reduced with this approach ( median ( range ) 1 ( 1–7 ) days versus 2 ( 1–10 ) days for patients who had a Lichtenstein repair ) . There was no significant difference in parenteral analgesia requirements or visual analogue pain scores between the two groups . Although use of oral analgesia in hospital was greater in patients who underwent Lichtenstein hernioplasty , this may reflect their longer stay . Rehabilitation to normal activity and return to work was shorter in patients receiving laparoscopic repair ( median 7 and 10 days , respectively ) than Lichtenstein repair ( 14 and 21 days ) ( P < 0·001 ) . Initial results suggest that laparoscopic procedures may be associated with more rapid rehabilitation compared with that of open tension‐free mesh surgery . Most patients with inguinal hernia undergoing tension‐free mesh repair by either technique would be suitable for day‐case surgery To evaluate the merits of laparoscopic inguinal hernia repair ( LHR ) compared to conventional open hernia repair ( OHR ) a r and omized study has been conducted . All patients were day surgical cases , of which 44 were r and omized to a st and ardized OHR under local anesthetic ( LA ) and 42 to an LHR under general anesthesia ( GA ) . Fifteen LHR patients had bilateral repairs . Operative time for OHR was 30.5 min , for unilateral LHR 35 min , and for bilateral LHR 60 min . OHR patients were discharged after a median of 134.5 min , which was significantly shorter than LHR patients , whose median discharge was 225 min ( P<0.01 ) . Pain scores , activity levels , analgesia requirements , and time taken to return to work were not significantly different following surgery in either group ( P<0.05 ) . There have been two recurrent hernias and one small bowel obstruction in the LHR group . We conclude that both repairs can be successfully performed as day surgical procedures . The added cost of LHR at this stage does not warrant its widespread use in unilateral hernia repairs . Which procedure is adopted should be individualized ; however , patients with bilateral hernias on presentation can be successfully managed as day cases , obviating the need for hospitalization or two operations In a prospect i ve r and omized study postoperative pain , analgesic consumption , return to physical activity and work , cosmetic result and experience with the type of operation were assessed in 86 patients undergoing inguinal hernia repair by means of either the Shouldice technique ( n = 34 ) , the laparoscopic transabdominal preperitoneal ( TAPP ) ( n = 28 ) or total preperitoneal ( TPP ) ( n = 24 ) repair . Patients having TAPP repair had decreased visual analogue scale scores for pain on the day of operation compared with those undergoing TPP and Shouldice repair ( 4.8 versus 6.5 and 6.2 respectively , P = 0.02 ) and on the first postoperative day compared with TPP ( 4.0 versus 6.0 , P = 0.01 ) . There was no difference between the three groups for days 2 , 3 , 4 , 5 and 30 after operation . Patient satisfaction with the operation , analgesic consumption , return to physical activity such as walking , driving , climbing stairs , running , bicycling and sexual intercourse , as well as return to work , was comparable in the three groups . There was a better cosmetic result after TAPP and TPP repair . This study failed to demonstrate significant benefits from laparoscopic hernia repair over the Shouldice technique Laparoscopic hernia operations have been criticized in regard to their high hospital costs . This study was design ed to compare the costs and some outcome features of totally extraperitoneal endoscopic hernia operation ( TEP ) and Lichtenstein mesh repair ( OPN ) among 45 r and omized employed patients . The medians of operative time in the TEP and OPN groups were 67.5 and 53 min , respectively . Return to normal life was 14 days in the TEP group and 20 days in the OPN group . The hospital costs per patient were $ 1,239 ( all costs are in US dollars ) in the TEP group and $ 782 in the OPN group . The median total costs were $ 3,912 and $ 4,661 in the TEP and OPN groups , respectively . The Lichtenstein operation is cheaper for the hospital . The total costs for working patients are lower with the endoscopic technique because fewer working days are lost BACKGROUND Inguinal hernias can be repaired by laparoscopic techniques , which have had better results than open surgery in several small studies . METHODS We performed a r and omized , multicenter trial in which 487 patients with inguinal hernias were treated by extraperitoneal laparoscopic repair and 507 patients were treated by conventional anterior repair . We recorded information about postoperative recovery and complications and examined the patients for recurrences one and six weeks , six months , and one and two years after surgery . RESULTS Six patients in the open-surgery group but none in the laparoscopic-surgery group had wound abscesses ( P=0.03 ) , and the patients in the laparoscopic-surgery group had a more rapid recovery ( median time to the resumption of normal daily activity , 6 vs. 10 days ; time to the return to work , 14 vs. 21 days ; and time to the resumption of athletic activities , 24 vs. 36 days ; P<0.001 for all comparisons ) . With a median follow-up of 607 days , 31 patients ( 6 percent ) in the open-surgery group had recurrences , as compared with 17 patients ( 3 percent ) in the laparoscopic-surgery group ( P=0.05 ) . All but three of the recurrences in the latter group were within one year after surgery and were caused by surgeon-related errors . In the open-surgery group , 15 patients had recurrences during the first year , and 16 during the second year . Follow-up was complete for 97 percent of the patients .
Output:
| REVIEW ER 'S CONCLUSIONS The use of mesh during laparoscopic hernia repair is associated with a relative reduction in the risk of hernia recurrence of around 30 - 50 % .
However , there is no apparent difference in recurrence between laparoscopic and open mesh methods of hernia repair .
The data suggests less persisting pain and numbness following laparoscopic repair .
Return to usual activities is faster .
However , operation times are longer and there appears to be a higher risk of serious complication rate in respect of visceral ( especially bladder ) and vascular injuries |
MS210932 | ***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: We performed yearly MRI analyses on 327 of the total 372 patients in a multicenter , r and omized , double-blind , placebo-controlled trial of interferon beta-1b ( IFNB ) . Clinical results are presented in the preceding companion paper . Baseline MRI characteristics were the same in all treatment groups . Fifty-two patients at one center formed a cohort for frequent MRIs ( one every 6 weeks ) for analysis of disease activity . The MRI results support the clinical results in showing a significant reduction in disease activity as measured by numbers of active scans ( median 80 % reduction , p = 0.0082 ) and appearance of new lesions . In addition , there was an equally significant reduction in MRI-detected burden of disease in the treatment as compared with placebo groups ( mean group difference of 23 % , p = 0.001 ) . These results demonstrate that IFNB has made a significant impact on the natural history of MS in these patients Objective : Interferon ( IFN ) beta has repeatedly shown benefit in multiple sclerosis ( MS ) in reducing the rate of relapse , the disease activity as shown with magnetic resonance imaging and , to some degree , the progression of disability ; however , it is unknown how much the therapeutic response depends on the dose , the subgroup involved , and the disease stage . This multicentre , double blind , placebo controlled study explored the dose−response curve by examining the clinical benefit of low dose IFN beta-1a ( Rebif ® ) , 22 μg subcutaneously once weekly , in patients with secondary progressive MS . Methods : A total of 371 patients with clinical ly definite SPMS were r and omised to receive either placebo or subcutaneous IFN beta-1a , 22 μg once weekly , for 3 years . Clinical assessment s were performed every 6 months . The primary outcome was time to sustained disability , as defined by time to first confirmed 1.0 point increase on the Exp and ed Disability Status Scale ( EDSS ) . Secondary outcomes included a sensitive disability measure and relapse rate . Results : Treatment had no beneficial effect on time to confirmed progression on either the EDSS ( hazard ratio ( HR ) = 1.13 ; 95 % confidence interval ( CI ) 0.82 to 1.57 ; p = 0.45 for 22 μg v placebo ) or the Regional Functional Status Scale ( HR = 0.93 ; 95 % CI 0.68 to 1.28 ; p = 0.67 ) . Other disability measures were also not significantly affected by treatment . Annual relapse rate was 0.27 with placebo and 0.25 with IFN ( rate ratio = 0.90 ; 95 % CI 0.64 to 1.27 ; p = 0.55 ) . The drug was well tolerated with no new safety concerns identified . No significant gender differences were noted . Conclusions : This patient population was less clinical ly active than SPMS population s studied in other trials . Treatment with low dose , IFN beta-1a ( Rebif ® ) once weekly did not show any benefit in this study for either disability or relapse outcomes , including a subgroup with preceding relapses . These results add a point at one extreme of the dose−response spectrum of IFN beta therapy in MS , indicating that relapses in this phase may need treatment with higher doses than in the initial phases Objective : To evaluate the efficacy and safety of interferon beta-1b ( IFNβ-1b ) in subjects with secondary progressive multiple sclerosis ( SPMS ) . Methods : This 3-year , multicenter , double-blind , placebo-controlled , r and omized trial of IFNβ-1b included 939 subjects from the United States and Canada with SPMS and Exp and ed Disability Status Scale ( EDSS ) scores ranging from 3.0 to 6.5 . Subjects were r and omly assigned to receive either placebo or IFNβ-1b ( 250 μg or 160 μg/m2 body surface area ) , administered subcutaneously every other day . The primary outcome was time to progression by ≥1.0 EDSS point ( 0.5 point if EDSS score was 6.0 to 6.5 at entry ) confirmed at 6 months . Secondary outcomes included mean change in EDSS score from baseline , relapse-related measures , MRI activity , and a st and ardized neuropsychological function test . Results : There was no significant difference in time to confirmed progression of EDSS scores between placebo-treated patients and either of the IFNβ-1b treatment groups . However , IFNβ-1b treatment result ed in improvement on secondary outcome measures involving clinical relapses , newly active MRI lesions , and accumulated burden of disease on T2-weighted MRI . Effects were similar for both IFNβ-1b treatment groups . Neutralizing antibodies to IFNβ-1b were detected in 23 % of 250-μg and 32 % of 160-μg/m2 recipients , but their presence did not consistently affect clinical or MRI outcomes . IFNβ-1b was also well tolerated at both doses . Conclusions : Although no treatment benefit was seen on the time to confirmed progression of disability , relapse- and MRI-related outcomes showed significant benefit with both dosing regimens tested , a result consistent with the outcomes of earlier clinical trials Background Interferon & bgr;-1a ( IFN&bgr;-1a , Avonex ) is efficacious in relapsing forms of MS . Studies of other IFN&bgr ; preparations in secondary progressive MS ( SPMS ) yielded conflicting results . This study was undertaken to determine whether IFN&bgr;-1a slowed disease progression in SP-MS . Methods A total of 436 subjects with SPMS and Exp and ed Disability Status Scale ( EDSS ) score 3.5 to 6.5 were r and omized to receive IFN&bgr;-1a ( 60 & mgr;g ) or placebo by weekly intramuscular injection for 2 years . The primary outcome measure , used for the first time in a large-scale MS trial , was baseline to month 24 change in the MS Functional Composite ( MSFC ) , comprising quantitative tests of ambulation ( Timed 25-Foot Walk ) , arm function ( Nine-Hole Peg Test [ 9HPT ] ) , and cognition ( Paced Auditory Serial Addition Test [ PASAT ] ) . Results Median MSFC Z-score change was reduced 40.4 % in IFN&bgr;-1a subjects ( −0.096 vs −0.161 in placebo subjects , p = 0.033 ) , an effect driven mainly by the 9HPT and PASAT . There was no discernible benefit on the EDSS , which in this range principally reflects walking ability . IFN&bgr;-1a subjects had 33 % fewer relapses ( p = 0.008 ) . There was significant benefit on eight of 11 MS Quality of Life Inventory subscales . New or enlarging T2-hyperintense brain MRI lesions and gadolinium-enhancing lesions were reduced at months 12 and 24 ( both p < 0.001 ) . IFN&bgr;-1a was well tolerated by the majority of subjects . Neutralizing antibodies developed in 3.3 % of IFN&bgr;-1a – treated subjects . Conclusions IFN&bgr;-1a demonstrated benefit on MSFC progression , relapses , quality of life , and MRI activity in SPMS The accepted st and ard treatment of relapsing multiple sclerosis consists of medications for disease symptoms , including treatment for acute exacerbations . However , currently there is no therapy that alters the progression of physical disability associated with this disease . The purpose of this study was to determine whether interferon beta‐1a could slow the progressive , irreversible , neurological disability of relapsing multiple sclerosis . Three hundred one patients with relapsing multiple sclerosis were r and omized into a double‐blinded , placebo‐controlled , multicenter phase I11 trial of interferon beta‐la . Interferon beta‐la , 6.0 million units ( 30 μg ) , was administered by intramuscular injection weekly . The primary outcome variable was time to sustained disability progression of at least 1.0 point on the Kurtzke Exp and ed Disability Status Scale ( EDSS ) . Interferon beta‐la treatment produced a significant delay in time to sustained EDSS progression ( p equals ; 0.02 ) . The Kaplan‐Meier estimate of the proportion of patients progressing by the end of 104 weeks was 34.9 % in the placebo group and 21.9 % in the interferon beta‐la‐treated group . Patients treated with interferon beta‐la also had significantly fewer exacerbations ( p = 0.03 ) and a significantly lower number and volume of gadolinium‐enhanced brain lesions on magnetic resonance images ( pvalues ranging between 0.02 and 0.05 ) . Over 2 years , the annual exacerbation rate was 0.90 in placebo‐treated patients versus 0.61 in interferon beta‐la‐treated patients . There were no major adverse events related to treatment . Interferon beta‐ la had a significant beneficial impact in relapsing multiple sclerosis patients by reducing the accumulation of permanent physical disability , exacerbation frequency , and disease activity measured by gadolinium‐enhanced lesions on brain magnetic resonance images . This treatment may alter the hndamen‐ tal course of relapsing multiple sclerosis There is currently no disease-modifying treatment proven to be of efficacy in primary progressive multiple sclerosis ( PPMS ) . However , a number of therapeutic trials have recently been specifically design ed for this group . These include a r and omised controlled trial of interferon beta-1a which is discussed here . It is hoped that therapeutics in primary progressive multiple sclerosis will continue to exp and and effective therapeutic agents will be developed The unique clinical characteristics of primary progressive multiple sclerosis ( PPMS ) pose particular diagnostic difficulties , both in excluding other causes of progressive syndromes and in confirming the diagnosis of MS , which is not adequately addressed by current diagnostic criteria . This article presents new diagnostic criteria developed by a group of investigators on the basis of a review of their considerable experience with PPMS . ( We conclude that at least 1 year of clinical progression must be documented before a diagnosis of PPMS is made . ) Three levels of diagnostic certainty have been defined — definite , probable , and possible — based on clinical findings , abnormal cerebrospinal fluid , abnormalities on magnetic resonance imaging ( MRI ) of the brain and spinal cord , and evoked potentials . In definite PPMS , evidence of intrathecal synthesis of immunoglobulin G together with one of the following three MRI criteria is required : ( 1 ) nine brain lesions , ( 2 ) two spinal cord lesions , or ( 3 ) four to eight brain lesions and one spinal cord lesion . Preliminary testing of these criteria was carried out on a cohort of 156 patients participating in a European natural history study of PPMS : 64 % fulfilled the criteria for definite PPMS , 35 % for probable PPMS , and only 1 % for possible PPMS . These criteria now require prospect i ve validation in a cohort of newly diagnosed patients and by postmortem examination . Ann Neurol
Output:
| Based on this review , the included studies showed that ss-interferon treatment was not associated with reduced disability progression in PPMS patients .
However , the trial population was too small to allow definitive conclusions on the efficacy of ss-interferon therapy in PPMS patients . |
MS210933 | ***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: Purpose Bladder cancer ( BC ) is one of the most common cancers worldwide . BC diagnosis and surveillance is based on cystoscopy ( CS ) . CS impact on patient ’s depression , anxiety , and sexual satisfaction ( SS ) is not sufficiently studied . There are no data on patient ’s comfort with flexible or rigid CS . Methods We prospect ively evaluated pain perception ( PP ) , depression , anxiety , and SS of 100 male patients who previously underwent at least one rigid CS in our department as surveillance after TURB procedure due to non-muscle-invasive BC and were scheduled for the next CS examination . The patients were r and omized for flexible or rigid CS . Before CS , patients described their recalled rigid CS-related pain by NRS and fulfilled HADS and SS question naires . After CS , PP was re-evaluated immediately and HADS and SS within 7–10 days following the CS . Results The baseline scores include 5.2 ± 2.6 points for rigid CS recalled pain , 7.2 ± 3.0 points for HADS anxiety , 5.8 ± 3.5 for depression , and 27.8 ± 5.1 for SS . The flexible CS-related pain was approximately three times lower than the recalled pain level and also than the current rigid CS related ( p < 0.001 ) . Mean SS score was two points lowered after rigid CS ( p < 0.001 ) . One point decrease in anxiety level was observed after flexible CS ( p < 0.001 ) . Multivariate analysis supported the hypothesis of patients benefiting from flexible CS in terms of pain perception , anxiety symptoms , and SS . Conclusions Our study demonstrates the superiority of flexible CS in terms of pain alleviation , and shifts in SS and anxiety levels To test the feasibility of a r and omised trial in muscle‐invasive bladder cancer ( MIBC ) and compare outcomes in patients who receive neoadjuvant chemotherapy followed by radical cystectomy ( RC ) or selective bladder preservation ( SBP ) , where definitive treatment [ RC or radiotherapy ( RT ) ] is determined by response to chemotherapy Background The use of web-based monitoring for lung cancer patients is growing in interest because of promising recent results suggesting improvement in cancer and re source utilization outcomes . It remains an open question whether the overall survival ( OS ) in these patients could be improved by using a web-mediated follow-up rather than classical scheduled follow-up and imaging . Methods Advanced-stage lung cancer patients without evidence of disease progression after or during initial treatment were r and omly assigned in a multicenter phase III trial to compare a web-mediated follow-up algorithm ( experimental arm ) , based on weekly self-scored patient symptoms , with routine follow-up with CT scans scheduled every three to six months according to the disease stage ( control arm ) . In the experimental arm , an alert email was automatically sent to the oncologist when self-scored symptoms matched predefined criteria . The primary outcome was OS . Results From June 2014 to January 2016 , 133 patients were enrolled and 121 were retained in the intent-to-treat analysis ; 12 deemed ineligible after r and om assignment were not subsequently followed . Most of the patients ( 95.1 % ) had stage III or IV disease . The median follow-up was nine months . The median OS was 19.0 months ( 95 % confidence interval [ CI ] = 12.5 to noncalculable ) in the experimental and 12.0 months ( 95 % CI = 8.6 to 16.4 ) in the control arm ( one-sided P = .001 ) ( hazard ratio = 0.32 , 95 % CI = 0.15 to 0.67 , one-sided P = .002 ) . The performance status at first detected relapse was 0 to 1 for 75.9 % of the patients in the experimental arm and for 32.5 % of those in the control arm ( two-sided P < .001 ) . Optimal treatment was initiated in 72.4 % of the patients in the experimental arm and in 32.5 % of those in the control arm ( two-sided P < .001 ) . Conclusions A web-mediated follow-up algorithm based on self-reported symptoms improved OS due to early relapse detection and better performance status at relapse Purpose To examine quality of life ( QoL ) , health status , sexual function , and anxiety in patients with primary hematuria who later appear to have bladder cancer ( BC ) and patients with other diagnoses . Methods From July 2007 to July 2010 , 598 patients with primary hematuria were enrolled in this prospect i ve , multicenter study . Question naires ( WHOQOL-BREF , SF-12 , IIEF , STAI-10-item Trait ) were completed before cystoscopy . Diagnosis was subsequently derived from medical files . BC patients were compared with patients with other causes of hematuria . Results Cancer was diagnosed in 131 patients ( 21.9 % ) , including 102 patients ( 17.1 % ) with BC . No differences were found in the WHOQOL-BREF versus SF-12 psychological or physical health domains . The erectile function was significantly worse in the BC group ( 9.3 vs. 14.6 for OC , p = 0.02 ) . Patients with muscle-invasive BC ( MIBC ) had the lowest percentage anxious personalities of all BC patients ( p = 0.04 ) . Conclusions Cancer was found in 21.9 % of the patients with hematuria . Pre-diagnosis patients with BC have comparable QoL and HS to patients with OC . Erectile dysfunction was highest in patients with BC . MIBC patients had the lowest percentage anxious personalities of the patients with BC PURPOSE There is growing interest to enhance symptom monitoring during routine cancer care using patient-reported outcomes , but evidence of impact on clinical outcomes is limited . METHODS We r and omly assigned patients receiving routine outpatient chemotherapy for advanced solid tumors at Memorial Sloan Kettering Cancer Center to report 12 common symptoms via tablet computers or to receive usual care consisting of symptom monitoring at the discretion of clinicians . Those with home computers received weekly e-mail prompts to report between visits . Treating physicians received symptom printouts at visits , and nurses received e-mail alerts when participants reported severe or worsening symptoms . The primary outcome was change in health-related quality of life ( HRQL ) at 6 months compared with baseline , measured by the EuroQol EQ-5D Index . Secondary endpoints included emergency room ( ER ) visits , hospitalizations , and survival . RESULTS Among 766 patients allocated , HRQL improved among more participants in the intervention group than usual care ( 34 % v 18 % ) and worsened among fewer ( 38 % v 53 % ; P < .001 ) . Overall , mean HRQL declined by less in the intervention group than usual care ( 1.4- v 7.1-point drop ; P < .001 ) . Patients receiving intervention were less frequently admitted to the ER ( 34 % v 41 % ; P = .02 ) or hospitalized ( 45 % v 49 % ; P = .08 ) and remained on chemotherapy longer ( mean , 8.2 v 6.3 months ; P = .002 ) . Although 75 % of the intervention group was alive at 1 year , 69 % with usual care survived the year ( P = .05 ) , with differences also seen in quality -adjusted survival ( mean of 8.7 v. 8.0 months ; P = .004 ) . Benefits were greater for participants lacking prior computer experience . Most patients receiving intervention ( 63 % ) reported severe symptoms during the study . Nurses frequently initiated clinical actions in response to e-mail alerts . CONCLUSION Clinical benefits were associated with symptom self-reporting during cancer care Objectives : i ) To evaluate objective response , toxicity , and quality of life ( QoL ) of gemcitabine monotherapy as second-line treatment in patients with cisplatin-refractory , metastatic transitional cell carcinoma ( TCC ) . ii ) To assess prognostic parameters for response to treatment and for improvement of QoL parameters . Patients and Methods : 30 patients were prospect ively enrolled in this open-label , nonr and omized multicenter phase II trial . Patients received up to 6 courses of gemcitabine monotherapy ( 1,250 mg/m2 on day 1 and 8 of a 21-day course ) . 28 of 30 patients were available for response evaluation . Results : Objective response ( OR ) was seen in 3/28 ( 11 % ) of patients ( 2 complete remissions , 1 partial remission ) . The mean time to progression ( TTP ) was 4.9 ± 3.5 months and mean disease-specific survival time was 8.7 ± 4.7 months . 13 of 28 patients did not progress ( OR + 10 stable diseases ) , and TTP ( 8.0 ± 2.7 months , p < 0.001 ) as well as survival time ( 10.2 ± 3.8 months , p < 0.05 ) differed significantly from those who showed progressive disease within 18 weeks of treatment . Pain values significantly improved in the group of responders from 4.3 ± 1.9 to 5.8 ± 1.3 points ( p < 0.05 ) . Response to cisplatin pretreatment was the best prognosticator for the response to gemcitabine . Conclusions : Gemcitabine monotherapy as second-line treatment is justified in patients with metastatic TCC who are refractory to cisplatin treatment . Patients with initially OR to cisplatin benefit most from second-line treatment . QoL remains stable during treatment , and pain improves especially in patients with bone metastases OBJECTIVES To explore the effects of cancer on psychosocial aspects of Pakistani patients and their families , assessing the need for interventions to improve their quality of life . METHODS A prospect i ve , Cross-sectional study was performed on 200 patients visiting the oncology outpatient facility of AKUH from December 2010 to May 2011 through an interview . Responses were recorded on pre- design ed question naires including FACT-G QOL ( Functional Assessment of Cancer Therapy-General Quality Of Life ) component . RESULTS Out of the 200 patients 52 ( 26 % ) were males and 148 ( 74 % ) were females . Mean age was 51.8 + /- 14.2 years . Breast cancer accounted for the commonest cancer in females 116 ( 58 % ) and lung in males 30 ( 15 % ) , 100 ( 50 % ) patients were currently undergoing chemotherapy . In all 148 ( 74 % ) patients were well aware of their diagnosis and were able to cope better and 142 ( 71 % ) were well supported by families ( majority being financially stable ) . Major financial impact was found in 42 ( 21 % ) cases . Religious/spiritual help was sought by 138 ( 69 % ) patients predominantly females- 113 ( 76 % ) and 22 ( 11 % ) patients consulted a psychiatrist ; 20 ( 94 % ) subjects of this group felt this intervention was helpful . Responses regarding effect on the patient 's sexual life were poor and 126 ( 63 % ) denied answering the question . CONCLUSION In our study one third of cancer patients were found to be depressed mainly affecting those who were receiving multimodality treatment or facing financial issues . Religious help was the main coping strategy for them BACKGROUND Radical radiotherapy for muscle-invasive urinary bladder cancer can sterilize the tumour with preserved organ function . Here we studied symptoms , symptom distress and trade-off among long-term survivors and compared figures to those of population controls and patients who had undergone cystectomy . MATERIAL S AND METHODS We identified 71 patients who had had urinary bladder cancer treated with radical radiotherapy before 1995 . For comparison , 325 patients treated with radical cystectomy and urostomy , continent or non-continent , during the same period and 460 individuals r and omly selected from the general population were included . Information was collected by means of an anonymously answered postal question naire to avoid investigator-related bias . RESULTS Answers were obtained from 58 ( 82 % ) radiated patients , 251 ( 85 % ) cystectomized patients and 310 ( 71 % ) population controls . Of the radiated patients , 74 % reported little or no distress from symptoms from the urinary tract , 38 % had had intercourse the previous month and 57 % ( men ) reported they had ejaculated . Among the cystectomized patients , 13 % had had intercourse and 0 % ( men ) had ejaculated . Moderate or much distress from symptoms from the gastrointestinal tract was reported by 32 % of the radiated patients , 24 % of the cystectomized patients and 9 % of the population controls . After radical radiotherapy , 46 % of the patients were willing to accept some risk of decreased survival to become symptom-free . CONCLUSIONS About 3/4 of these long-term survivors after radical radiotherapy for bladder cancer had a functioning urinary bladder with little or no distress from the urinary tract . The prevalence of sexual dysfunction was lower than after cystectomy and the prevalence of distress from the gastrointestinal tract was comparable OBJECTIVES The aim of the population -based study presented here was to evaluate quality of life ( QOL ) among bladder cancer survivors at least five years after diagnosis , ascertain the long term effects of treatments , and investigate important pathological and sociodemographic factors influencing the QOL of such survivors . METHODS A Functional
Output:
| From the studies included the overall QoL seemed inversely related to the organ-specific impairment from sexual and urinary symptoms and increased with decreasing organ-specific symptoms for long term survivors > 6 months after treatment . |
MS210934 | ***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 This survey was intended to investigate prevalence and severity of early childhood caries ( ECC ) in a sample of children in Southern Italy and to identify factors that may be related to this condition . Methods The study was design ed as a cross-sectional survey . The study population ( children aged 36–71 months ) attending thirteen kindergartens was r and omly selected through a two-stage cluster sampling procedure . Parents/guardians of all eligible children were invited to participate filling out a structured self-administered question naire , and after having returned the informed consent form an oral examination of the child was performed at school . The question naire included information on : socio-demographics about parents/guardians and child , pregnancy and newborn characteristics , oral hygiene habits of child , eating habits particularly on consumption of sweets , access to dental services , and infant feeding practice s. The WHO caries diagnostic criteria for deciduous decayed , missing and filled teeth ( dmft ) and surfaces ( dmfs ) were used to record ECC and severe-ECC ( S-ECC ) . Univariate and multiple logistic regression analyses were conducted to evaluate statistical associations of social demographics , infant feeding practice s , oral hygiene habits , and access to dental services to ECC , S-ECC , dmft and dmfs . Results 515 children participated in the study . 19 % had experienced ECC , and 2.7 % S-ECC , with a mean dmft and dmfs scores of 0.51 and 0.99 , respectively . Mean dmft was 2.68 in ECC subjects , and 6.86 in S-ECC subjects . Statistical analysis showed that prevalence of ECC significantly increased with age ( OR = 1.95 ; 95 % CI = 1.3 - 2.91 ) and duration of breastfeeding ( OR = 1.26 ; 95 % CI = 1.01 - 1.57 ) , whereas it was significantly lower in children of more educated mothers ( OR = 0.64 ; 95 % CI = 0.42 - 0.96 ) , and higher in those who had been visited by a dentist in the previous year ( OR = 3.29 ; 95 % CI = 1.72 - 6.33 ) . Conclusions Results of our study demonstrate that even in Western countries ECC and S-ECC represent a significant burden in preschool children , particularly in those disadvantaged , and that most of the known modifiable associated factors regarding feeding practice s and oral hygiene are still very spread in the population OBJECTIVE To demonstrate the effectiveness of a dental caries prevention program on the primary dentition of Chilean rural children , using fluori date d powdered milk and milk derivatives . METHODS Fluori date d milk and milk-cereal was given to about 1000 preschool children in Codegua , a rural community located in the 6th Region of Chile , using the st and ard National Complementary Feeding Program ( PNAC ) . The daily fluoride dose from fluori date d powdered milk was estimated at 0.25 mg for infants ( 0 - 2 years old ) , 0.5 mg for children aged 2 - 3 years and 0.75 for children aged 3 - 6 years . Cross-sectional sample s of children aged 3 - 6 years were taken from Codegua ( study community ) from 1994 to 1999 and from La Punta ( control community ) from 1997 and 1999 . RESULTS Significant reductions ( 72 % ) were observed in the dmfs indices in the 3 - 6-year-old groups in Codegua , when comparing 1999 with 1994 data . In 1999 , children in the study community showed significantly lower dmfs than children in the control community ( 41 % ) . The proportion of caries-free children in the study community increased after 4 years of program implementation ( from 22.0 % to 48.4 % ) . CONCLUSION Under Chilean rural conditions , fluoridation of powdered milk distributed through the PNAC is an effective caries prevention alternative for areas where water fluoridation might not be feasible Objectives The purpose of this study is to investigate the contribution of selected variables to the occurrence of severe early childhood caries ( S-ECC ) in 3- to 5-year-old kindergarten children . Methods A cross-sectional study was conducted in 2010 in 30 r and omly selected kindergartens in the German Rhein-Neckar district . After informed consent , parents were asked to complete a question naire . The oral examinations took place in the selected kindergartens and the WHO methods as well as the criteria proposed by the American Academy of Pediatric Dentistry were followed . Logistic regression was applied to explore the main factors contributing to S-ECC in a multivariate model . Results In all , 1,007 children aged 3 to 5 years with an average age of 4.1 ( SD = 0.8 ) years were examined . Five variables were associated significantly with the occurrence of S-ECC : breastfeeding for more than 12 months ( OR = 3.27 ) , use of the nursing bottle in bed ( OR = 3.08 ) , start of tooth brushing after the first anniversary ( OR = 2.42 ) , regular visits at the dentists ( OR = 0.14 ) and mother with immigration background ( OR = 4.05 ) . Prevalence rate of S-ECC was 9.5 % . The mean d3 + 4mft values were 5.69 ( S-ECC group ) and 0.23 ( non-S-ECC group ) . Conclusion These results show that occurrence of S-ECC is a complex interaction between socioeconomic , psychological and behavioural factors of parents . New and specific ways to provide preventive dental care for toddlers and infants of caries risk groups have to be developed . Clinical relevance Parents of newborn children have to receive information about timely start of tooth brushing and adequate use of nursing bottles The purpose of this study was to describe the dietary habits of infants and toddlers living in Sweden with special reference to caries prevalence at 2 and 3 years of age and to immigrant status . The study was design ed as a prospect i ve , longitudinal study starting with 671 children aged 1 year . At 3 years , all children were invited to a further examination . A total of 298 individuals , r and omly selected from the original group , were also examined at 2 years . The accompanying parent was interviewed about the child 's dietary habits . Children with caries at 2 and 3 years of age and immigrant children had , when they were 1 year old , consumed caries-risk products and been given nocturnal meals and sweetened liquid in a feeding bottle more often than caries-free 2- and 3-year-olds and non-immigrant children . Although a great variation in dietary habits was found in infants and toddlers , the use of sugar-containing products is widespread in Sweden even in early childhood OBJECTIVES To evaluate the significance of variables such as oral hygiene , dietary habits , socio-economic status and medical history of a child in assessing the level of caries risk and to generate a caries prediction model for pre-school Saudi children . DESIGN Cross-sectional study of pre-school children . SETTING Clinics and schools in Riyadh , Saudi Arabia . SAMPLE AND METHODS A sample of 446 Saudi pre-school children , 199 males and 247 females , with a mean age of 4.13 years , were selected at r and om from clinics and schools . Selection was limited to subjects who either had no caries ( dmft = 0 ) or who had high caries experience ( dmft > 8) . Each child was examined for caries experience and oral hygiene status . Their mothers were interviewed through a st and ardized question naire for information about oral hygiene habits of the children , diet history , childhood illness and socio-economic status . RESULTS There was a highly significant difference between the two groups in : debris index ( P < 0.0001 ) , aged child started tooth brushing , ( P < 0.0001 ) , age breastfeeding was stopped ( P < 0.005 ) , nocturnal bottle feeding with milk formula ( P < 0.001 ) , use of sweetened milk ( P < 0.0001 ) , frequency of use of soft drinks ( P < 0.0005 ) , frequency of consumption of sweets ( P < 0.0001 ) , and age at first dental visit ( P < 0.0001 ) . A caries prediction model developed through stepwise multivariate Logistic Regression ( LR ) analyses showed debris index , use of sweetened milk in bottle , frequency of consumption of soft drinks , frequency of intake of sweets and child 's age at the first dental visit to be significant . Predictive probability of the model was 86.31 % with a sensitivity of 90.1 % and a specificity of 80.6 % . CONCLUSIONS Risk factors for dental caries have been identified and a caries prediction model has been developed for Saudi pre-school children . The prediction model , if verified , may provide with guidance in identifying high caries risk Saudi preschool children as targets for preventive programmes OBJECTIVE Despite a marked improvement in oral health of Australian children over the last 30 years , severe early childhood caries ( S-ECC ) affects up to 17 % of 2- to 3-year-old children with some requiring hospitalization and invasive treatment . This provided a compelling rationale to develop and test an oral health promotion programme which aim ed to reduce this unnecessary suffering . The purpose of this study was to test the efficacy of an oral health promotion programme for the parents of infants , starting during the pregnancy , using a r and omized controlled trial . METHODS A programme was developed around the provision of anticipatory guidance to nulliparous women ( women expecting their first child ) in Adelaide . Mothers in the test group received oral health promotion information during pregnancy , and later when the child reached 6 and 12 months of age . After the second round of information the test group mothers were r and omized again . The information was reinforced in one of the test subgroups through a telephone consultation . There was no contact with mothers in the control group after enrolment . At the age of 20 + /- 2.5 months all test and control group children were examined by a dentist . The case definition of an incidence of S-ECC was one or more upper incisor teeth being carious at the level of a cavitated or noncavitated lesion . The differences in S-ECC incidence between the test and control groups , and the test subgroups were analysed . RESULTS Of 649 women enroled in the programme ( test group 327 , control group 322 ) , 441 had their child examined at follow-up . The incidence of S-ECC in the test group was 1.7 % and in the control group 9.6 % ( P < 0.001 ) . CONCLUSION An oral health promotion programme based on repeated rounds of anticipatory guidance initiated during the mother 's pregnancy was successful in reducing the incidence of S-ECC in these very young children PURPOSE The purpose s of this r and omized controlled trial were to : ( 1 ) test motivational interviewing ( MI ) to prevent early childhood caries ; and ( 2 ) use Poisson regression for data analysis . METHODS A total of 240 South Asian children 6 to 18 months old were enrolled and r and omly assigned to either the MI or control condition . Children had a dental exam , and their mothers completed pretested instruments at baseline and 1 and 2 years postintervention . Other covariates that might explain outcomes over and above treatment differences were modeled using Poisson regression . Hazard ratios were produced . RESULTS Analyses included all participants whenever possible . Poisson regression supported a protective effect of MI ( hazard ratio [HR]=0.54 (95%CI=035 - 0.84)-that is , the M/ group had about a 46 % lower rate of dmfs at 2 years than did control children . Similar treatment effect estimates were obtained from models that included , as alternative outcomes , ds , dms , and dmfs , including " white spot lesions . " Exploratory analyses revealed that rates of dmfs were higher in children whose mothers had : ( 1 ) prechewed their food ; ( 2 ) been raised in a rural environment ; and ( 3 ) a higher family income ( P<.05 ) . CONCLUSIONS A motivational interviewing-style intervention shows promise to promote preventive behaviors in mothers of young children at high risk for caries Fluori date d milk reduced caries increment by about 70 % OBJECTIVES Assess the effectiveness of home visits for advising mothers about breast feeding and weaning on early childhood caries ( ECC ) at the age of 12 months . METHODS A r and omized field trial was conducted in mothers who gave birth within the public health system in the Brazilian city of Sao Leopoldo ( intervention group = 200 ; controls = 300 ) . The intervention group received the advice 10 days after the child 's birth , monthly up to 6 months , at 8 , 10 and 12 months , based on the ' Ten Steps for Healthy Feeding ' , a Brazilian national health policy for primary care , based on WHO guidelines . Both groups had research assessment at 6 and 12 months , with dental caries investigated in this last assessment ; 122 children were lost in the 1-year follow-up ; 378 were assessed for caries : two predentulous children were excluded from the analysis . Mann-Whitney U was used to test if the average number of decayed surfaces ( DS ; white spots and cavities ) differed between the intervention and control groups , and logistic regression to estimate the effects of the intervention on the odd
Output:
| Conclusion : The best available evidence indicates that breastfeeding up to 2 y of age does not increase ECC risk .
Providing access to fluori date d water and educating caregivers are justified approaches to ECC prevention . |
MS210935 | ***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: This study examines the personal and attitudinal variables that are associated with helping behavior in a hypothetical general practice setting . We explored the effect of an antistigma seminar during a psychiatric clerkship on medical students ’ attitudes toward the mentally ill . We r and omly assigned three rotations of students ( 81 students ) to receive the seminar and three rotations ( 85 students ) as controls . The students expressed views about patients with schizophrenia or depressive disorder portrayed in video vignettes . How dangerous the students perceived target individuals to be was the major determinant of helping behavior . The students ’ gender , religious affiliation , affective reaction , skill assessment , and controllability attribution were less consistent in predicting behavior . Exposure to the seminar and clerkship experience significantly improved attitudes , but attributes of responsibility and readiness to provide medical care for psychiatric patients were the most resistant to change . We identified certain issues that should be highlighted in future antistigma programs This study explores the effect of classroom theory and contact with mentally ill patients on the attitudes of student nurses . The independent variables were ( a ) pre-class stage , ( b ) post-class stage , and ( c ) post- clinical placement stage . A total of 72 students took part in the study . While there were two significant changes in responses to specific attitudes at the post-class stage , there were three significant changes in responses to specific attitudes at the post- clinical stage on patients ' characteristics . However , when responses to all attitudes pertaining towards patients ' characteristics were grouped , there was no overall significant change at the post- clinical experience stage . Also , for attitudes towards patients ' treatment , there were significant changes in responses to two specific attitudes at the post-class stage and to three specific attitudes at the post- clinical experience stage . Furthermore , the highly significant positive change in attitudes towards patients ' treatment in the post-class stage remained highly significant at the post- clinical experience stage . This confirms that classroom theory , prior to clinical experience , can effect students ' attitudes towards patients treatment . In addition , students ' evaluative comments , while being critical of some aspects of their clinical placements , did not necessarily affect their attitudes towards the characteristics or treatment of the mentally ill Rreliminary evidence suggests that mental health consumers can successfully serve as peer companions , case management aides , case managers , job coaches , and drop-in center staff . However , few empirical investigations have addressed the use of consumers to train mental health professionals . This project employed a r and omized design to test the effects of using consumers as trainers for mental health service providers . Fifty-seven state mental health professionals participated in a two-day training design ed to acquaint trainees with the attitudes and knowledge necessary for delivering assertive case management services . Participants were r and omly assigned to one of two conditions : one in which they received the second day of training from a consumer and the other involving training by a nonconsumer . Analyses revealed that post-training attitudes were significantly more positive for those participants trained by the consumer . Subjective evaluations also reflected positive reactions to the use of consumers as trainers . Implication s for further use of mental health consumers as trainers are explored BACKGROUND A school mental-health programme has been developed as a component of the community mental-health programme in Rawalpindi , Pakistan . It has the objective of improving the underst and ing of disorders of mental health in the rural community . We aim ed to assess the impact of a school mental-health programme on the awareness of schoolchildren , their parents , friends who were not attending school , and neighbours . METHODS We chose two secondary schools for boys and two for girls that were similar in terms of size , staff-pupil ratio , and drop-out rates . 100 children aged 12 - 16 years ( 25 girls and 25 boys in each of the study and control groups ) , 100 parents ( one for each child ) , 100 friends who did not attend school ( one for each child ) , and 100 neighbours ( one for each child ) were given a 19-item question naire before and after the study group had had a 4-month programme of mental-health education . The maximum score for the question naire was 16 points . FINDINGS Before the school mental-health programme the awareness of mental-health issues was poor ( mean score 5.7 - 7.6 ) in the four groups of participants . In the study group there was a significant improvement in the mean scores after the school programme in the schoolchildren ( mean improvement 7.6 [ 95 % CI 6.7 - 8.5 ] , p<0.01 ) , their parents ( 5.3 [ 4.5 - 6.1 ] , p<0.01 ) , friends ( 5.1 [ 4.1 - 6.1 ] , p<0.01 ) , and neighbours ( 3.4 [ 2.6 - 4.2 ] , p<0.01 ) . In the control group the difference in awareness was significant only in schoolchildren ( 1.5 [ 0.5 - 2.3 ] , p=0.01 ) and their friends ( 0.8 [ 0.3 - 1.3 ] , p<0.01 ) . INTERPRETATION The school programme succeeded in improving awareness of mental health in schoolchildren and the community . The schoolchildren were receptive to the programme , and shared their new underst and ing with family , friends , and neighbours . Mental-health planners who wish to improve community awareness of mental health , particularly in areas with low literacy rates , should consider setting up school mental-health programmes This study evaluated the effectiveness of a cognitive behaviour therapy Internet program ( MoodGYM ) for depressive symptoms , attributional style , self‐esteem and beliefs about depression , and on depression and depression‐vulnerable status in male youth . A total of 78 boys age 15 and 16 years were allocated to either undertake MoodGYM or to st and ard personal development activities . Outcomes were measured before commencement , post‐program and 16 weeks post‐program . There were no significant between‐group differences in change scores pre‐ to post‐ or pre‐ to follow‐up using the intention to treat sample or for participants with post‐ and /or follow‐up data . For boys completing 3 or more modules there were small relative benefits of MoodGYM for depressive symptoms ( Effect Size , ES = 0.34 ) , attributional style ( ES = 0.17 ) and self‐esteem ( ES = 0.16 ) at post‐program , although only the effect for self‐esteem was sustained at follow‐up . Both groups showed improvement in their beliefs about depression at follow‐up , with the control group showing a moderate relative benefit ( ES = 0.40 ) . While the numbers are small , there was a reduction in the risk of being depressed in the MoodGYM group of 9 % at post‐treatment compared with a slightly increased risk for the control group . The risk of being classified as vulnerable to depression reduced by 17 % in the MoodGYM group at post‐treatment compared with no change in risk for the control group . These reductions in risk for the MoodGYM group were not sustained at follow‐up . The limitations of the study highlight several important challenges for MoodGYM and other self‐directed Internet cognitive behaviour therapy programs . These include how to ensure enough of the program is received and that people who could potentially benefit access the program and continue to remain engaged with it , and how to enhance the sustainability of any benefits Trauma risk management ( TRiM ) is an intensive posttraumatic stress disorder ( PTSD ) psychoeducational management strategy based on peer-group risk assessment developed by the UK Royal Navy ( RN ) . TRiM seeks to modify attitudes about PTSD , stress , and help-seeking and trains military personnel to identify at-risk individuals and refer them for early intervention . This quasiexperimental study found that TRiM training significantly improved attitudes about PTSD , stress , and help-seeking from TRiM-trained personnel . There was a nonsignificant effect on attitudes to seeking help from normal military support networks and on general health . Within both the military and civilian population s , stigma is a serious issue preventing help-seeking and reducing quality of life . The results suggest that TRiM is a promising antistigma program within organizational setting The effects of three strategies for changing stigmatizing attitudes -- education ( which replaces myths about mental illness with accurate conceptions ) , contact ( which challenges public attitudes about mental illness through direct interactions with persons who have these disorders ) , and protest ( which seeks to suppress stigmatizing attitudes about mental illness)--were examined on attributions about schizophrenia and other severe mental illnesses . One hundred and fifty-two students at a community college were r and omly assigned to one of the three strategies or a control condition . They completed a question naire about attributions toward six groups -- depression , psychosis , cocaine addiction , mental retardation , cancer , and AIDS -- prior to and after completing the assigned condition . As expected , results showed that education had no effect on attributions about physical disabilities but led to improved attributions in all four psychiatric groups . Contact produced positive changes that exceeded education effects in attributions about targeted psychiatric disabilities : depression and psychosis . Protest yielded no significant changes in attributions about any group . This study also examined the effects of these strategies on processing information about mental illness
Output:
| The vast majority of studies reported positive intervention effects .
It appears easier to improve knowledge or to change misconceptions of mental disorders than to reduce the tendency to distance oneself from people with mental illness .
When directly comparing the effect of interventions based exclusively on education with those combining education with facilitating contact with people with mental disorders , the latter proved more effective .
A remarkable number of targeted interventions aim ed at reducing the stigma attached to mental illness have been carried out . |
MS210936 | ***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 need to identify biomarkers for bevacizumab-based treatment in advanced colorectal cancer is imperative . The aim of this study was to investigate the prognostic role of circulating VEGF , PDGF , SDF-1 , osteopontin and CEA in patients r and omly assigned to three bevacizumab-based regimens . Plasma sample s from 50 patients treated at a single Institution were analysed using the multiplex assay BioPlex ™ 2200 ( Bio-Rad Laboratories , Inc , Berkeley , CA , USA ) at baseline , before first three cycles and subsequently every three cycles until disease progression . Prognostic analyses of baseline values were performed using multivariable Cox models , including disease extension > 10 cm or ≤10 cm ( measured as the sum of the diameters for all target lesions ) as adjustment factor . The association between progression-free and overall survival and biomarkers modulation during treatment was studied using multivariable Cox models , which included summary statistics synthesizing during-treatment modulation together with disease extension . The biomarkers significantly associated with disease extension were baseline CEA ( p = 0.012 ) and SDF-1 ( p = 0.030 ) . High values of VEGF and SDF-1 tended to be associated with worse prognosis , especially in terms of overall survival . The negative prognostic trend was more marked for baseline CEA as compared to other biomarkers ; increasing values during treatment was significantly related to worse prognosis independently of disease extension ( p = 0.007 and 0.016 for progression-free and overall survival , respectively ) . VEGF is related to bevacizumab pharmacodynamics and is associated to other angiogenic cytokines ; some of the proposed biomarkers such as SDF-1 and CEA should be further vali date d for prognosis assessment and monitoring of bevacizumab-based treatment of advanced colorectal cancer Introduction : We previously reported the prognostic significance of the lung adenocarcinoma immune microenvironment . In this study , we preformed comprehensive analysis of immune markers and their associations with prognosis in patients with lung squamous cell carcinoma . Methods : We review ed surgically resected , solitary lung squamous cell carcinoma patients ( n = 485 ; 1999–2009 ) who were r and omly split into a training cohort ( n = 331 ) and validation cohort ( n = 154 ) . We constructed tissue microarrays and performed immunostaining for CD3 , CD45RO , CD8 , CD4 , FoxP3 , CD20 , CD68 , CXCL12 , CXCR4 , CCR7 , interleukin-7 receptor , and interleukin-12 receptor & bgr;2 . Overall survival ( OS ) was analyzed using the log-rank test and the Cox proportional hazards model . Results : Analysis of single immune cell infiltration revealed that high tumor-infiltrating CD10 + neutrophils were associated with worse prognoses in the training cohort ( p = 0.021 ) . Analysis of biologically relevant immune cell combinations identified that patients with high CD10 + neutrophil and low CD20 + lymphocyte had a significantly worse OS ( 5-year OS , 42 % ) than those with other combinations of CD10 and CD20 ( 5-year OS , 62 % ; p < 0.001 ) ; this was confirmed in the validation cohort ( p = 0.032 ) . For the multivariate analysis , high CD10/low CD20 immune cell infiltration was an independent predictor of OS in both the training cohort ( hazard ratio = 1.61 , p = 0.006 ) and the validation cohort ( hazard ratio = 1.75 ; p = 0.043 ) . Conclusion : High CD10+/low CD20 + immune cell infiltration ratio is a significant prognostic factor of lung squamous cell carcinoma . Immunomodulatory therapy of tumor-specific neutrophil and B-lymphocyte responses may have applicability in the treatment of lung squamous cell carcinoma PURPOSE To evaluate the safety , efficacy and biomarkers of short-course proton beam radiation and capecitabine , followed by pancreaticoduodenectomy in a phase 1/2 study in pancreatic ductal adenocarcinoma ( PDAC ) patients . METHODS AND MATERIAL S Patients with radiographically resectable , biopsy-proven PDAC were treated with neoadjuvant short-course ( 2-week ) proton-based radiation with capecitabine , followed by surgery and adjuvant gemcitabine . The primary objective was to demonstrate a rate of toxicity grade ≥ 3 of < 20 % . Exploratory biomarker studies were performed using surgical specimen tissues and peripheral blood . RESULTS The phase 2 dose was established at 5 daily doses of 5 GyE. Fifty patients were enrolled , of whom 35 patients were treated in the phase 2 portion . There were no grade 4 or 5 toxicities , and only 2 of 35 patients ( 4.1 % ) experienced a grade 3 toxicity event ( chest wall pain grade 1 , colitis grade 1 ) . Of 48 patients eligible for analysis , 37 underwent pancreaticoduodenectomy . Thirty of 37 ( 81 % ) had positive nodes . Locoregional failure occurred in 6 of 37 resected patients ( 16.2 % ) , and distant recurrence occurred in 35 of 48 patients ( 72.9 % ) . With median follow-up of 38 months , the median progression-free survival for the entire group was 10 months , and overall survival was 17 months . Biomarker studies showed significant associations between worse survival outcomes and the KRAS point mutation change from glycine to aspartic acid at position 12 , stromal CXCR7 expression , and circulating biomarkers CEA , CA19 - 9 , and HGF ( all , P<.05 ) . CONCLUSIONS This study met the primary endpoint by showing a rate of 4.1 % grade 3 toxicity for neoadjuvant short-course proton-based chemoradiation . Treatment was associated with favorable local control . In exploratory analyses , KRAS(G12D ) status and high CXCR7 expression and circulating CEA , CA19 - 9 , and HGF levels were associated with poor survival Background CXCL12 has been widely reported to play a biologically relevant role in tumor growth and spread . In epithelial ovarian cancer ( EOC ) , CXCL12 enhances tumor angiogenesis and contributes to the immunosuppressive network . However , its prognostic significance remains unclear . We thus compared CXCL12 status in healthy and malignant ovaries , to assess its prognostic value . Methods Immunohistochemistry was used to analyze CXCL12 expression in the reproductive tracts , including the ovaries and fallopian tubes , of healthy women , in benign and borderline epithelial tumors , and in a series of 183 tumor specimens from patients with advanced primary EOC enrolled in a multicenter prospect i ve clinical trial of paclitaxel/carboplatin/gemcitabine-based chemotherapy ( GINECO study ) . Univariate COX model analysis was performed to assess the prognostic value of clinical and biological variables . Kaplan-Meier methods were used to generate progression-free and overall survival curves . Results Epithelial cells from the surface of the ovary and the fallopian tubes stained positive for CXCL12 , whereas the follicles within the ovary did not . Epithelial cells in benign , borderline and malignant tumors also expressed CXCL12 . In EOC specimens , CXCL12 immunoreactivity was observed mostly in epithelial tumor cells . The intensity of the signal obtained ranged from strong in 86 cases ( 47 % ) to absent in 18 cases ( < 10 % ) . This uneven distribution of CXCL12 did not reflect the morphological heterogeneity of EOC . CXCL12 expression levels were not correlated with any of the clinical parameters currently used to determine EOC prognosis or with HER2 status . They also had no impact on progression-free or overall survival . Conclusion Our findings highlight the previously unappreciated constitutive expression of CXCL12 on healthy epithelia of the ovary surface and fallopian tubes , indicating that EOC may originate from either of these epithelia . We reveal that CXCL12 production by malignant epithelial cells precedes tumorigenesis and we confirm in a large cohort of patients with advanced EOC that CXCL12 expression level in EOC is not a valuable prognostic factor in itself . Trial Registration Clinical Trials.gov : The development of tumor biomarkers ready for clinical use is complex . We propose a refined system for biomarker study design , conduct , analysis , and evaluation that incorporates a hierarchal level of evidence scale for tumor marker studies , including those using archived specimens . Although fully prospect i ve r and omized clinical trials to evaluate the medical utility of a prognostic or predictive biomarker are the gold st and ard , such trials are costly , so we discuss more efficient indirect " prospect ive-retrospective " design s using archived specimens . In particular , we propose new guidelines that stipulate that 1 ) adequate amounts of archived tissue must be available from enough patients from a prospect i ve trial ( which for predictive factors should generally be a r and omized design ) for analyses to have adequate statistical power and for the patients included in the evaluation to be clearly representative of the patients in the trial ; 2 ) the test should be analytically and preanalytically vali date d for use with archived tissue ; 3 ) the plan for biomarker evaluation should be completely specified in writing before the performance of biomarker assays on archived tissue and should be focused on evaluation of a single completely defined classifier ; and 4 ) the results from archived specimens should be vali date d using specimens from one or more similar , but separate , studies
Output:
| Conclusions : Determination of CXCL12 expression has the potential to be of use as a cancer biomarker and adds prognostic information in various cancer types . |
MS210937 | ***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: Asthma self-management programmes have been shown to increase children 's knowledge about asthma and improve their management practice s and health status . However , existing programmes have rarely addressed the unique learning needs of very young children . This study aim ed to develop and assess the effectiveness of a video tape and picture book design ed to teach children about the prevention and management of acute episodes of asthma . The information content of the educational re sources was determined by analysis of relevant medical information and asthma management skills . Social Learning Theory and consideration of the developmental stage of the target population informed the format and style of presentation of the re sources . Eighty children aged between 2 and 5 years who had been diagnosed with asthma by their medical practitioner and who required daily asthma medication participated in a controlled experimental study . The study evaluated the impact of the asthma education re sources on children 's knowledge about asthma , compliance with medication regimens and health status . Children were r and omly allocated to one of three experimental groups . Children in these groups were exposed to either the video tape alone , the book alone or both the video tape and book , or to a control group who viewed material s unrelated to asthma . The results for the three experimental groups were compared with the control group who did not receive exposure to any of the asthma education re sources . The results showed that children in each experimental group had significantly greater gains in asthma-related knowledge than children in the control group and children exposed to both re sources showed the greatest increases in knowledge . Children in each of the three experimental groups also had better compliance and health than children in the control group . These findings indicate that carefully design ed asthma education re sources are useful for providing even the youngest children with information about asthma and its management OBJECTIVE To test the validity and short-term responsiveness to change of a pediatric , asthma-specific , health-related quality -of-life ( HRQL ) instrument . METHODS Children 2 years and older treated in the emergency department ( ED ) for acute asthma were eligible for this prospect i ve cohort study . A 10-item instrument , the Integrated Therapeutics Group Child Asthma Short Form ( ITG-CASF ) , was administered at the time of the ED visit and again 14 days later ( via telephone ) . At the follow-up call , parents were also asked about the child 's current overall asthma status , missed school or limited activities , and persistence of asthma symptoms . RESULTS A total of 121 children were enrolled ( mean age , 7.9 years ) , and follow-up was complete for 96 ( 79 % ) . Mean + /- SD ITG-CASF scores at follow-up were significantly higher among children reported to have improved overall ( 61.8 + /- 19.6 ) than those not improved ( 41.9 + /- 21.2 ) , and there was a significant correlation between ITG-CASF score at follow-up and the number of days of school missed or limited activities ( r = -0.45 ; 95 % confidence interval [ CI ] , -0.24 to -0.66 ) . There was also a significant difference in improvement in ITG-CASF score from ED visit to follow-up among those improved ( 13.7-point improvement ) compared with those not improved ( 3.3-point improvement ; difference = 10.4 ; 95 % CI , 1.2 to 19.5 ) . The effect size was 0.68 , indicating a large responsiveness to change . CONCLUSIONS The ITG-CASF is a valid and responsive measure of HRQL in children with acute asthma and may be a useful outcome measure in evaluating ED treatment BACKGROUND Children with asthma who live in the inner city are exposed to multiple indoor allergens and environmental tobacco smoke in their homes . Reductions in these triggers of asthma have been difficult to achieve and have seldom been associated with decreased morbidity from asthma . The objective of this study was to determine whether an environmental intervention tailored to each child 's allergic sensitization and environmental risk factors could improve asthma-related outcomes . METHODS We enrolled 937 children with atopic asthma ( age , 5 to 11 years ) in seven major U.S. cities in a r and omized , controlled trial of an environmental intervention that lasted one year ( intervention year ) and included education and remediation for exposure to both allergens and environmental tobacco smoke . Home environmental exposures were assessed every six months , and asthma-related complications were assessed every two months during the intervention and for one year after the intervention . RESULTS For every 2-week period , the intervention group had fewer days with symptoms than did the control group both during the intervention year ( 3.39 vs. 4.20 days , P<0.001 ) and the year afterward ( 2.62 vs. 3.21 days , P<0.001 ) , as well as greater declines in the levels of allergens at home , such as Dermatophagoides farinae ( Der f1 ) allergen in the bed ( P<0.001 ) and on the bedroom floor ( P=0.004 ) , D. pteronyssinus in the bed ( P=0.007 ) , and cockroach allergen on the bedroom floor ( P<0.001 ) . Reductions in the levels of cockroach allergen and dust-mite allergen ( Der f1 ) on the bedroom floor were significantly correlated with reduced complications of asthma ( P<0.001 ) . CONCLUSIONS Among inner-city children with atopic asthma , an individualized , home-based , comprehensive environmental intervention decreases exposure to indoor allergens , including cockroach and dust-mite allergens , result ing in reduced asthma-associated morbidity BACKGROUND Asthma continues to be a substantial cause of morbidity in pediatric population s. New strategies are needed to provide cost-effective educational interventions for children with asthma , particularly those in the inner city . OBJECTIVE To assess the effectiveness of a multimedia educational software program about asthma . SETTING A hospital-based primary care clinic and an affiliated neighborhood health center . DESIGN R and omized , controlled trial . POPULATION Children 3 to 12 years old with physician-diagnosed asthma . INTERVENTION An interactive educational computer program , Asthma Control , design ed to teach children about asthma and its management . Using a graphic display of a child going through simulated daily events , the game emphasizes : 1 ) monitoring ; 2 ) allergen identification ; 3 ) use of medications ; 4 ) use of health services ; and 5 ) maintenance of normal activity . Control group participants review ed printed educational material s with a research assistant . OUTCOMES Acute health care use ( emergency department and outpatient ) was the primary outcome . Secondary outcome measures included maternal report of asthma symptom severity , child functional status and school absences , satisfaction with care , and parental and child knowledge of asthma . RESULTS A total of 137 families were enrolled in the study ( 76 intervention , 61 control ) . Both intervention and control groups showed substantial improvement in all outcomes during the 12-month follow-up period . Aside from improvement in knowledge after use of the computer program , no differences were demonstrated between the 2 groups in primary or secondary outcome measures . Children reported enjoyment of program use . CONCLUSIONS This trial of an educational software program found that it did not produce greater improvement than occurred with review of traditional written material s. Because both groups showed substantial improvement over baseline , computer-based education may be more cost-effective . Alternatively , improvements in illness severity over time may overshadow the effects of such interventions . Rigorous comprehensive evaluations such as this are necessary to assess new interventions intended to improve management and outcomes of asthma Background : The effects on morbidity were examined of providing an educational intervention and a written guided self-management plan to the parents of pre-school children following a recent attendance at hospital for asthma or wheeze . Methods : A prospect i ve , r and omised , partially blinded , controlled trial was design ed at two secondary care centres . Over a 13 month period 200 children aged 18 months to 5 years at the time of admission to a children 's ward or attendance at an accident and emergency department or children 's ( emergency ) assessment unit ( A&E/CAU ) with a primary diagnosis of acute severe asthma or wheezing were recruited . 101 children were r and omised into the control group and received usual care and 99 were assigned to the intervention group and received : ( 1 ) a pre-school asthma booklet ; ( 2 ) a written guided self-management plan ; and ( 3 ) two 20 minute structured educational sessions between a specialist respiratory nurse and the parent(s ) and child . Subjects were assessed at 3 , 6 , and 12 months . The main outcomes were GP consultation rates , hospital re-admissions , and attendances at A&E/CAU . Secondary outcomes included disability score , caregivers ' quality of life , and parental knowledge of asthma . Results : There were no statistically significant differences between the two groups during the 12 month follow up period for any of the main or secondary outcome measures . Conclusions : These results do not support the hypothesis that the introduction of an educational package and a written guided self-management plan to the parents of pre-school children with asthma who had recently attended hospital for troublesome asthma or wheeze reduces morbidity over the subsequent 12 months Background : In clinical trials of asthma , the outcomes are often good , but when the same treatment regimens are implemented in primary care , equally good results are not obtained . Objective : To investigate if addition of structured patient information and monitoring by an asthma diary in primary care improves asthma control . Methods : 141 patients from 19 primary care centres were studied . The centres were r and omised to a st and ard care group or to an intervention group . The intervention group received structured written and oral information about asthma and asthma medication , and were instructed to keep an asthma diary . The primary outcome was asthma control as assessed by the Asthma Control Question naire . Secondary outcomes were costs of asthma medication , the Mini Asthma Quality of Life Question naire score and lung function . Results : Asthma Control Question naire score changes differed between the study groups ( p < 0.05 ) . In the intervention group , these changes ( M = –0.45 ) in asthma control were close to clinical significance ( minimal important difference ≈0.5 ) . Both groups improved in disease-specific quality of life scores . For the intervention group , which changed the most ( p < 0.05 ) , the change exceeded the threshold for the minimal important difference ( 0.5 ) . The costs of medications increased significantly in the intervention group , where adjustments of medication were made more often than in controls . Conclusion : Disease-specific quality of life of asthma patients could be improved by adding structured information and monitoring by diary to st and ard care This study was conducted to test the efficacy of AIR WISE , an individually administered asthma self-management program . Subjects were paired and r and omly assigned to either an experimental group ( N = 7 ) or a control group ( N = 7 ) . The frequency of experimental group emergency visits , analyzed over a 12-month posttreatment period , was substantially less than those of the control group , supporting the hypothesis that AIR WISE is effective in high-utilizer children through improved self-management The effects on self management of asthma of a specially prepared book and audiocassette tape with similar contents were observed in a controlled study of 177 patients with asthma in general practice . After a run in period of six months patients were r and omly given the book , the tape , both the book and tape , or neither . Patients ' knowledge of the use of drugs , perceptions of their disability , skill in using an inhaler , consumption of drugs , consultations with their general practitioners , morbidity ( from patients ' entries on diary cards ) , and use of the educational material were measured . Knowledge about the use of drugs was significantly increased in the groups who received the material after three months and persisted after 12 months . Patients who had been given the tape or the book and tape increased their scores of knowledge of drugs more than patients given the book alone . Patients in all groups given the material considered that their disability was reduced . There were no other significant changes . Patients given both the book and the tape preferred the book . Patients with asthma can obtain useful information from such material . The paradoxical result whereby patients learnt more from the tape but preferred the book suggests that a distinction can be made between information that patients need , which may be acquired better from an audiocassette , and information that they want , which may be acquired better from a book A r and omized , controlled trial was conducted to assess the effectiveness of Blue Angel for Asthma Kids , an Internet-based interactive asthma educational and monitoring program , used in the management of asthmatic children . One hundred sixty-four ( n = 164 ) pediatric patients with persistent asthma were enrolled and r and omized into two study groups for a 12-week controlled trial . The intervention group had 88 participants who were taught to monitor their peak expiratory flows ( PEF ) and asthma symptoms daily on the Internet . They also received an interactive response consisting of a self-management plan from the Blue Angel monitoring program . The control group had 76 participants who received a traditional asthma care plan consisting of a written asthma diary supplemented with instructions for self-management . Disease control was assessed by weekly averaged PEF values , symptom scores , and asthma control tests . Adherence measures were assessed by therapeutic and diagnostic monitoring . Outcome was assessed by examining quality of life and retention of asthma knowledge . The data were analyzed by comparing results before and after the trial . At the end of trial , the intervention group decreased nighttime ( -0.08 + /- 0.33 vs. 0.00 + /- 0.20 , p = 0.028 ) and daytime symptoms ( -0.08 + /- 0.33 vs. 0.01 + /- 0.18 , p = 0.009 ) ; improved morning ( 2
Output:
| Hospital admissions also demonstrated wide variation between trials with significant changes in some trials in both directions .
Quality of life improved in both education and control groups over time .
We found inconsistent evidence for home-based asthma educational interventions compared to st and ard care , education delivered outside of the home or a less intensive educational intervention delivered at home . |
MS210938 | ***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 occurrence of acquired rifamycin resistance despite use of directly observed therapy for tuberculosis is associated with advanced human immunodeficiency virus ( HIV ) disease and highly intermittent administration of antituberculosis drugs . Beyond these associations , the pathogenesis of acquired rifamycin resistance is unknown . METHODS We performed a pharmacokinetic sub study of patients in a trial of treatment with twice-weekly rifabutin and isoniazid . RESULTS A total of 102 ( 60 % ) of 169 patients in the treatment trial participated in the pharmacokinetic sub study , including 7 of 8 patients in whom tuberculosis treatment failure or relapse occurred in association with acquired rifamycin-resistant mycobacteria ( hereafter , " ARR failure or relapse " ) . The median rifabutin area under the concentration-time curve ( AUC(0 - 24 ) ) was lower for patients with than for patients without ARR failure or relapse ( 3.3 vs. 5.2 microg*h/mL ; P = .06 , by the Mann-Whitney exact test ) . In a multivariate analysis adjusted for CD4 + T cell count , the mean rifabutin AUC(0 - 24 ) was significantly lower for patients with ARR failure or relapse than for other patients ( 3.0 microg*h/mL [ 95 % confidence interval { CI } , 1.9 - 4.5 ] vs. 5.2 microg*h/mL [ 95 % CI , 4.6 - 5.8 ] ; P = .02 , by analysis of covariance ) . The median isoniazid AUC(0 - 12 ) was not significantly associated with ARR failure or relapse ( 20.6 vs. 28.0 microg*h/mL ; P = .24 , by the Mann-Whitney exact test ) . However , in a multivariate logistic regression model that adjusted for the rifabutin AUC(0 - 24 ) , a lower isoniazid AUC(0 - 12 ) was associated with ARR failure or relapse ( OR , 10.5 ; 95 % CI , 1.1 - 100 ; P = .04 ) . CONCLUSIONS Lower plasma concentrations of rifabutin and , perhaps , isoniazid were associated with ARR failure or relapse in patients with tuberculosis and HIV infection treated with twice-weekly therapy This report from the Tuberculosis Chemotherapy Centre , Madras , summarizes the progress over a 5-year period of 193 patients with newly diagnosed , sputum-positive pulmonary tuberculosis who were admitted to a concurrent comparison of home and sanatorium treatment for one year with isoniazid plus PAS . Previous reports have shown that , despite the traditional advantages of sanatorium treatment-rest , adequate diet , nursing and supervised drug-administration-the home patients responded nearly as well as the sanatorium patients in the first year ; further , the relapse rates over a 2-year period of follow-up were similar . The findings in the present report are based on a 4-year period of follow-up and extend these conclusions , the relapse rates over the period being 7 % for the home patients and 10 % for the sanatorium patients . Patients who failed to respond to treatment in the first year and those who had a bacteriological relapse in the second or subsequent years were usually re-treated with reserve regimens , first with streptomycin plus pyrazinamide and , if this was ineffective , with cycloserine plus ethionamide . Considering the findings over the entire 5-year period , five home patients and three sanatorium patients died from non-tuberculous causes . Of the remainder , 5 % of the home patients and 6 % of the sanatorium patients died of tuberculosis , 4 % in each series had bacteriologically active disease at five years and 90 % and 89 % , respectively , had bacteriologically quiescent disease at that time . These findings are very encouraging , particularly for developing countries such as India , where tuberculosis is a major problem and sanatorium beds are very few This report is the last of a series of nine publications from the Tuberculosis Chemotherapy Centre , Madras , concerning various aspects of an investigation of the role of ambulatory chemotherapy for pulmonary tuberculosis . It presents the attack rates of tuberculosis over a 5-year period of follow-up of close family contacts of patients , all of whom were treated for one year with isoniazid plus PAS , half ( selected at r and om ) in sanatorium and half at home . The incidence of active tuberculosis and of tuberculous infections was no greater in the contacts of patients treated at home than in the contacts of patients treated in sanatorium , either in the first year or over the subsequent four years . The major risk to the contacts result ed from exposure to the patient before diagnosis . These findings reaffirm that close family contacts of patients treated at home were at no additional risk of developing tuberculosis , provided the patients received effective chemotherapy . Finally , this study has shown that it is possible in South India to obtain extremely good co-operation from a group of families over a period of several years While directly observed treatment ( DOT ) has been recommended as the st and ard approach to tuberculosis control , empirical data on its feasibility and efficiency are still scarce . We conducted a controlled trial of DOT at 15 health care facilities at various levels of the government health care system in Thail and . A total of 836 patients diagnosed between August 1996 and October 1997 were r and omly assigned to be treated either under DOT or self-supervised using monthly drug supplies ( SS ) . Options for treatment supervisors were health staff , community members or members of the patients ' families . Treatment outcomes were compared on the basis of cure , treatment-completion , default and death rates . In both study arms , treatment outcomes were improved compared to pre- study conditions . Cure and treatment-completion rates were significantly higher in the DOT cohort ( 76 % and 84 % ) than in the SS group ( 67 % and 76 % ) . The benefits of DOT were more pronounced at district and provincial hospitals ( DOT cure rate 81 % vs. 69 % in the SS group ) , while differences for patients treated at referral centres were non-significant ( DOT cure rate 72 % vs. 66 % in the SS group ) . No significant differences in outcomes could be observed between patient groups receiving DOT under the various options for treatment supervisors . DOT appears especially suited for treatment at de central ized facilities . While a general focus on programme performance can improve outcomes , DOT provides significant additional benefits . If basic conditions are met , a DOT strategy can be tailored to country-specific conditions by exploring multiple observation options , without decreasing its effectiveness The bacteriological relapse rates up to 30 months after the start of chemotherapy have been compared for 4 daily short-course regimens for pulmonary tuberculosis . All 4 had the same initial 2-month intensive phase of streptomycin , isoniazid , rifampicin and pyrazinamide ( SHRZ ) followed by isoniazid plus rifampicin for 4 months ( 4HR ) , or isoniazid plus pyrazinamide for 4 months ( 4HZ ) , or isoniazid alone for 4 months ( 4H ) , or isoniazid alone for 6 months ( 6H ) . In patients with fully sensitive strains pretreatment , the 6-month regimen with rifampicin throughout ( 4HR ) was highly effective , only 2 % of 166 patients relapsing bacteriologically in 24 months of follow-up after stopping chemotherapy . This regimen was significantly better than the 4H regimen which had a relapse rate of 10 % in 156 patients ( P less than 0.02 ) and the 4HZ regimen which had a relapse rate of 8 % in 164 patients ( P = 0.05 ) . The 6H regimen was also highly effective , only 3 % of the 123 patients relapsing , compared with 10 % of the 156 on the 4H regimen ( P = 0.06 ) . The relapse rate of the regimen with pyrazinamide throughout ( 4HZ ) , was not significantly different from that of either of the regimens with isoniazid alone in the continuation phase . All except 3 ( 1 4HR , 1 4HZ , 1 4H ) of the 36 relapses were with fully drug-sensitive strains . In patients with strains resistant to isoniazid alone pretreatment none of the 23 on the 4HR or 4HZ regimens had an unfavourable bacteriological status at the end of chemotherapy compared with 8 of the 17 patients ( P less than 0.005 ) on 4H or 6H regimens . Of the patients assessed , 3 of 20 receiving rifampicin or pyrazinamide throughout relapsed compared with 2 of 8 who did not To underst and why once-weekly isoniazid/rifapentine therapy for tuberculosis was less effective than twice-weekly isoniazid/rifampin , we studied human immunodeficiency virus-seronegative patients with either failure ( n = 4 ) , relapse ( n = 35 ) , or cure ( n = 94 ) , recruited from a comparative treatment trial . In multivariate analyses that were adjusted for severity of disease , low plasma concentrations of isoniazid were associated with failure/relapse with once-weekly isoniazid/rifapentine ( median isoniazid area under the concentration-time curve for 12 hours after the dose [ AUC(0 - 12 ) ] was 36 microg x hour/ml in failure/relapse versus 56 microg x hour/ml in control cases p = 0.005 ) , but not with twice-weekly isoniazid/rifampin . Furthermore , two patients who relapsed with Mycobacterium tuberculosis monoresistant to rifamycin had very low concentrations of isoniazid . Finally , isoniazid acetylator status determined by N-acetyltransferase type 2 genotype was associated with outcome with once-weekly isoniazid/rifapentine ( p = 0.03 ) but not twice-weekly isoniazid/rifampin . No rifamycin pharmacokinetic parameter was consistently and significantly associated with outcome ( p > 0.10 ) . Because low isoniazid concentrations were associated with failure/relapse , a drug with consistently greater area under the concentration-time curve than isoniazid may be needed to achieve highly active once-weekly therapy with rifapentine One daily and 3 thrice weekly retreatment regimens given for 12 months under programme conditions were compared . The daily regimen was rifampicin and ethambutol ( RE7 ) . The three intermittent regimens also contained rifampicin and ethambutol : one of them , rifampicin and ethambutol throughout ( RE3 ) ; the next one supplemented with pyrazinamide for the first 3 months ( REZ3 ) ; the last one supplemented with prothionamide for the first 3 months ( REPt3 ) . The pyrazinamide containing regimen was subdivided into ordinary and high dose groups . The subjects for retreatment were those who have had , at least , more than 6 months of initial triple chemotherapy of isoniazid , PAS and streptomycin at the health centres , and failed to convert to bacteriologically negative status . Among 419 patients who were available for sensitivity tests before commencing retreatment , 393 ( 94.3 % ) were resistant to isoniazid . Six hundred and seventy-four patients ( 674 ) were allocated r and omly to the regimens : 64 patients were excluded due to various pretreatment reasons and 109 did not complete 12 months of chemotherapy . There remain 501 patients who completed their retreatment . As assessed at 12 months , a bacteriologically favourable response was achieved in 68 % of 135 RE7 patients , 62 % of 129 RE3 patients , 74 % of 132 REZ3 patients , and in 79 % of 108 REPt3 patients . Adverse reactions were uncommon : 4 % in RE7 , 5 % in RE3 and 9 % in REZ3 , but 32 % in REPt3 . Relapse rates during 2 years after termination of chemotherapy were 15 % in RE7 , 14 % in RE3 and REZ3 , and 26 % in REPt3 , as calculated by life table analysis BACKGROUND Tuberculosis is a major public-health problem in South Africa , made worse by poor adherence to and frequent interruption of treatment . Direct observation ( DO ) of tuberculosis patients taking their drugs is supposed to improve treatment completion and outcome . We compared DO with self-supervision , in which patients on the same drug regimen are not observed taking their pills , to assess the effect of each on the success of tuberculosis treatment . METHODS We undertook an unblinded r and omised controlled trial in two communities with large tuberculosis caseloads . The trial included 216 adults who started pulmonary tuberculosis treatment for the first time , or who had a second course of treatment ( retreatment patients ) . No changes to existing treatment delivery were made other than r and omisation . Analysis was by intention to treat . Individual patient data from the two communities were combined . FINDINGS Treatment for tuberculosis was more successful among self-supervised patients ( 60 % of patients ) than among those on DO ( 54 % of patients , difference between groups 6 % [ 90 % CI -5.1 to 17.0 ] ) . Retreatment patients had significantly more successful treatment outcomes if self-supervised ( 74 % of patients ) than on DO ( 42 % of patients , difference between groups 32 % [ 11%-52 % ] ) . INTERPRETATION At high rates of treatment interruption , self
Output:
| Findings suggest high levels of evidence for using daily dosing schedules , especially during the initial phase in the presence of cavitation , isoniazid resistance and advanced HIV co-infection , to reduce the risk of treatment failure , recurrence and acquired drug resistance including acquired rifamycin resistance . |
MS210939 | ***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 study the efficacy of eye movement desensitization and reprocessing ( EMDR ) with traumatized young women , 60 women between the ages of 16 and 25 were r and omly assigned to two sessions of either EMDR or an active listening ( AL ) control . Factorial ANOVA interaction effects and simple main effects for outcome measures ( Beck Depression Inventory , State-Trait Anxiety Inventory , Penn Inventory for Posttraumatic Stress Disorder , Impact of Event Scale , Tennessee Self-Concept Scale ) indicated significant improvement for both groups and significantly greater pre-post change for EMDR-treated participants . Pre-post effect sizes for the EMDR group averaged 1.56 compared to 0.65 for the AL group . Despite treatment brevity , the posttreatment outcome variable means of EMDR-treated participants compared favorably with nonpatient or successfully treated norm groups on all measures IMPORTANCE The efficacy of posttraumatic stress disorder ( PTSD ) treatments in psychosis has not been examined in a r and omized clinical trial to our knowledge . Psychosis is an exclusion criterion in most PTSD trials . OBJECTIVE To examine the efficacy and safety of prolonged exposure ( PE ) therapy and eye movement desensitization and reprocessing ( EMDR ) therapy in patients with psychotic disorders and comorbid PTSD . DESIGN , SETTING , AND PARTICIPANTS A single-blind r and omized clinical trial with 3 arms ( N = 155 ) , including PE therapy , EMDR therapy , and waiting list ( WL ) of 13 outpatient mental health services among patients with a lifetime psychotic disorder and current chronic PTSD . Baseline , posttreatment , and 6-month follow-up assessment s were made . INTERVENTIONS Participants were r and omized to receive 8 weekly 90-minute sessions of PE ( n = 53 ) , EMDR ( n = 55 ) , or WL ( n = 47 ) . St and ard protocol s were used , and treatment was not preceded by stabilizing psychotherapeutic interventions . MAIN OUTCOMES AND MEASURES Clinician-rated severity of PTSD symptoms , PTSD diagnosis , and full remission ( on the Clinician-Administered PTSD Scale ) were primary outcomes . Self-reported PTSD symptoms and posttraumatic cognitions were secondary outcomes . RESULTS Data were analyzed as intent to treat with linear mixed models and generalized estimating equations . Participants in the PE and EMDR conditions showed a greater reduction of PTSD symptoms than those in the WL condition . Between-group effect sizes were 0.78 ( P < .001 ) in PE and 0.65 ( P = .001 ) in EMDR . Participants in the PE condition ( 56.6 % ; odds ratio [ OR ] , 3.41 ; P = .006 ) or the EMDR condition ( 60.0 % ; OR , 3.92 ; P < .001 ) were significantly more likely to achieve loss of diagnosis during treatment than those in the WL condition ( 27.7 % ) . Participants in the PE condition ( 28.3 % ; OR , 5.79 ; P = .01 ) , but not those in the EMDR condition ( 16.4 % ; OR , 2.87 ; P = .10 ) , were more likely to gain full remission than those in the WL condition ( 6.4 % ) . Treatment effects were maintained at the 6-month follow-up in PE and EMDR . Similar results were obtained regarding secondary outcomes . There were no differences in severe adverse events between conditions ( 2 in PE , 1 in EMDR , and 4 in WL ) . The PE therapy and EMDR therapy showed no difference in any of the outcomes and no difference in participant dropout ( 24.5 % in PE and 20.0 % in EMDR , P = .57 ) . CONCLUSIONS AND RELEVANCE St and ard PE and EMDR protocol s are effective , safe , and feasible in patients with PTSD and severe psychotic disorders , including current symptoms . A priori exclusion of individuals with psychosis from evidence -based PTSD treatments may not be justifiable . TRIAL REGISTRATION is rct n.com Identifier : IS RCT N79584912 BACKGROUND Previous research indicates a high prevalence of post-traumatic stress disorder ( PTSD ) and depression among refugees . Eye movement desensitization and reprocessing ( EMDR ) is an effective treatment for PTSD for victims of natural disasters , car accidents or other traumatic events . The current study examined the effect of EMDR on symptoms of PTSD and depression by comparing the treatment with a wait-list control condition in Syrian refugees . METHOD Adult refugees located in Kilis Refugee Camp at the Turkish-Syrian border with a PTSD diagnosis were r and omly allocated to either EMDR ( n = 37 ) or wait-list control ( n = 33 ) conditions . All participants were assessed with the Mini-International Neuropsychiatric Interview Plus at pre-intervention , at 1 week after finishing the intervention and at 5 weeks after finishing the intervention . The main outcome measures were the Harvard Trauma Question naire ( HTQ ) and the Impact of Event Scale-Revised . The Beck Depression Inventory and the Hopkins Symptoms Checklist-25 were included as secondary outcome measures . The Trial Registration no. is NCT01847742 . RESULTS Mixed-model analyses adjusted for the baseline scores indicated a significant effect of group at post-treatment indicating that the EMDR therapy group showed a significantly larger reduction of PTSD symptoms as assessed with the HTQ . Similar findings were found on the other outcome measures . There was no effect of time or group × time interaction on any measure , showing that the difference between the groups at the post-treatment was maintained to the 5-week follow-up . CONCLUSIONS EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees with PTSD located in a refugee camp OBJECTIVE The relative short-term efficacy and long-term benefits of pharmacologic versus psychotherapeutic interventions have not been studied for posttraumatic stress disorder ( PTSD ) . This study compared the efficacy of a selective serotonin reup-take inhibitor ( SSRI ) , fluoxetine , with a psychotherapeutic treatment , eye movement desensitization and reprocessing ( EMDR ) , and pill placebo and measured maintenance of treatment gains at 6-month follow-up . METHOD Eighty-eight PTSD subjects diagnosed according to DSM-IV criteria were r and omly assigned to EMDR , fluoxetine , or pill placebo . They received 8 weeks of treatment and were assessed by blind raters posttreatment and at 6-month follow-up . The primary outcome measure was the Clinician-Administered PTSD Scale , DSM-IV version , and the secondary outcome measure was the Beck Depression Inventory-II . The study ran from July 2000 through July 2003 . RESULTS The psychotherapy intervention was more successful than pharmacotherapy in achieving sustained reductions in PTSD and depression symptoms , but this benefit accrued primarily for adult-onset trauma survivors . At 6-month follow-up , 75.0 % of adult-onset versus 33.3 % of child-onset trauma subjects receiving EMDR achieved asymptomatic end-state functioning compared with none in the fluoxetine group . For most childhood-onset trauma patients , neither treatment produced complete symptom remission . CONCLUSIONS This study supports the efficacy of brief EMDR treatment to produce substantial and sustained reduction of PTSD and depression in most victims of adult-onset trauma . It suggests a role for SSRIs as a reliable first-line intervention to achieve moderate symptom relief for adult victims of childhood-onset trauma . Future research should assess the impact of lengthier intervention , combination treatments , and treatment sequencing on the resolution of PTSD in adults with childhood-onset trauma Eye movement desensitization and reprocessing ( EMDR ) is a new method developed to treat posttraumatic stress disorder ( PTSD ) . This study evaluated the efficacy of EMDR compared to a no-treatment wait-list control in the treatment of PTSD in adult female sexual assault victims . Twenty-one subjects were entered , and 18 completed . Treatment was delivered in four weekly individual sessions . Assessment s were conducted pre- and posttreatment and 3 months following treatment termination by an independent assessor kept blind to treatment condition . Measures included st and ard clinician- and self-administered PTSD and related psychopathology scales . Results indicated that subjects treated with EMDR improved significantly more on PTSD and depression from pre- to posttreatment than control subjects , leading to the conclusion that EMDR was effective in alleviating PTSD in this study BACKGROUND Unanswered questions from controlled studies of posttraumatic stress disorder concern the value of cognitive restructuring alone without prolonged exposure therapy and whether its combination with prolonged exposure is enhancing . METHODS In a controlled study , 87 patients with posttraumatic stress disorder of at least 6 months ' duration were r and omly assigned to have 10 sessions of 1 of 4 treatments : prolonged exposure ( imaginal and live ) alone ; cognitive restructuring alone ; combined prolonged exposure and cognitive restructuring ; or relaxation without prolonged exposure or cognitive restructuring . RESULTS Integrity of audiotaped treatment sessions was satisfactory when rated by an assessor unaware of the treatment assignment . Seventy-seven patients completed treatment . The pattern of results was similar regardless of rater , statistical method , measure , occasion , and therapist . Exposure and cognitive restructuring , singly or combined , improved posttraumatic stress disorder markedly on a broad front . Gains continued to 6-month follow-up and were significantly greater than the moderate improvement from relaxation . CONCLUSION Both prolonged exposure and cognitive restructuring were each therapeutic on their own , were not mutually enhancing when combined , and were each superior to relaxation OBJECTIVE This study was design ed to explore the acceptability , feasibility , and initial efficacy of a new shelter-based treatment for victims of intimate partner violence ( IPV ; i.e. , Helping to Overcome PTSD through Empowerment [ HOPE ] ) . METHOD A Phase I r and omized clinical trial comparing HOPE ( n = 35 ) with st and ard shelter services ( SSS ) ( n = 35 ) was conducted . Primary outcome measures included the Clinician-Administered PTSD Scale ( CAPS ; D. D. Blake et al. , 1995 ) and the Conflict Tactic Scales-Revised ( M. A. Straus , S. L. Hamby , S. Boney-McCoy , & D. B. Sugarman , 1996 ) . Participants were followed at 1-week , 3- and 6-months postshelter . RESULTS Participants reported HOPE to be credible and indicated a high degree of satisfaction with treatment . Only 2 women withdrew from treatment . Both intent to treat ( ITT ) and minimal attendance ( MA ) analyses found that HOPE treatment relative to SSS was significantly associated with a lower likelihood of reabuse over the 6-month follow-up period ( OR = 5.1 , RR = 1.75 ; OR = 12.6 , RR = 3.12 , respectively ) . Results of hierarchical linear model analyses found a significant treatment effect for emotional numbing symptom severity in the ITT sample , t(67 ) = -2.046 , p < .05 , and significant treatment effects for effortful avoidance symptom severity , t(49 ) = -2.506 , p < .05 , and arousal symptom severity , t(49 ) = -2.04 , p < .05 , in the MA sample . Significant effects were also found for depression severity , empowerment , and social support . CONCLUSIONS Results support the acceptability and feasibility of HOPE and suggest that HOPE may be a promising treatment for IPV victims in shelter . However , results also suggest that modifications to HOPE may be required to improve treatment outcomes The effects of 3 90-min eye movement desensitization and reprocessing ( EMDR ) treatment sessions on traumatic memories of 80 participants were studied . Participants were r and omly assigned to treatment or delayed-treatment conditions and to 1 of 5 licensed therapists trained in EMDR . Participants receiving EMDR showed decreases in presenting complaints and in anxiety and increases in positive cognition . Participants in the delayed-treatment condition showed no improvement on any of these measures across the 30 days before treatment , but after treatment participants in the delayed-treatment condition showed similar effects on all measures . The effects were maintained at 90-day follow-up This controlled study evaluated the relative efficacy of Prolonged Exposure ( PE ) and Eye Movement Desensitization and Reprocessing ( EMDR ) compared to a no-treatment wait-list control ( WAIT ) in the treatment of PTSD in adult female rape victims ( n = 74 ) . Improvement in PTSD as assessed by blind independent assessors , depression , dissociation , and state anxiety was significantly greater in both the PE and EMDR group than the WAIT group ( n = 20 completers per group ) . PE and EMDR did not differ significantly for change from baseline to either posttreatment or 6-month follow-up measurement for any quantitative scale The authors conducted a r and omized clinical trial of individual psychotherapy for women with posttraumatic stress disorder ( PTSD ) related to childhood sexual abuse ( n = 74 ) , comparing cognitive-behavioral therapy ( CBT ) with a problem-solving therapy ( present-centered therapy ; PCT
Output:
| This is despite the findings from an associated systematic review which concluded that EMDR leads to loss of PTSD diagnosis and symptom reduction .
Depression symptoms were also found to improve more with EMDR than control conditions .
In that review , EMDR was marked down on strength of evidence ( SOE ) for symptom reduction for PTSD .
Secondly , even if the original measure was chosen , we highlight inconsistencies with the way SOE was assessed for EMDR , CT , and CPT .
Including both studies results in st and ard mean difference and confidence intervals that were better for EMDR than for CPT or CT . |
MS210940 | ***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 use youth and parent demographic factors , youth assets ( strengths ) , and community constructs to develop age-group-specific profiles for youth who abstain from sexual activity . METHODS Data were collected using in-person interviews of youth ( N = 1253 ) residing in r and omly selected , inner-city neighborhood households . Data were analyzed to create classification trees . RESULTS Results indicated that assets typically were the most important factors related to abstinence and that the profiles differed for each age group . CONCLUSIONS When sexual abstinence is considered , the influence of youth and parent demographics , youth assets , and community factors appears to vary across adolescent developmental age periods BACKGROUND The purpose of this study was to investigate the effect of sexual activity on cycle ergometer stress test parameters , on plasmatic testosterone levels and on concentration capacity in high-level male athletes . METHODS Experimental design . Analysis of two days of testing accomplished in a laboratory setting , comparing a day with to a day without sexual activity ( control day ) . Participants . Fifteen high-level male athletes , consisting of 8 team players , 5 endurance athletes and 2 weight-lifters , participated in the study . Measures . Each subject completed the following on each test day : two maximal grade d stress tests on a cycle ergometer and a one-hour exercise stress test coupled to an arithmetic mental concentration test . Blood sample s of testosterone were obtained and cardiac activity of each athlete was monitored with a 24-hour ECG tape recording over the two test days . RESULTS Significantly higher differences were achieved for post-effort heart rate ( HR ) values at 5 minutes ( p<0.01 ) and at 10 minutes ( p<0.01 ) during the recovery phase of the morning stress test 2 hours after sexual activity . These differences disappeared during the recovery phase of the afternoon stress test performed approximately 10 hours after sexual intercourse took place . CONCLUSIONS Our findings show that sexual activity had no detrimental influence on the maximal workload achieved and on the athletes ' mental concentration . However , the higher posteffort HR values after the maximal stress test on the morning of sexual intercourse suggest that the recovery capacity of an athlete could be affected if he had sexual intercourse approximately 2 hours before a competition event It is well known that athletes in the United States are told to abstain from sexual intercourse prior to athletic competition . The rationale for such a policy appears to be related to the hypothesis that sexual intercourse decreases the athletes ' ability to perform efficiently and /or maximally . But the effect that sexual intercourse may have on exercise performance has not been examined widely . Very likely , the restrictions placed on athletes have little to do with the athletes ' physiological ability to substain a particular exercise intensity and /or perform maximally . The purpose of this study was to determine the effects of sexual intercourse 12 hours prior to maximal treadmill exercise on aerobic power , oxygen pulse , and double product ( i.e. , an index of relative cardiac work ) . Eleven male subjects were tested on the treadmill with and without prior sexual intercourse . The results from the maximal exercise tests showed that aerobic power , oxygen pulse , and double product were not different . Therefore , the data suggest that it is justified to dismiss the point of view that sexual intercourse decreases maximal exercise performance
Output:
| The impact of sexual activity before a sport competition is still unclear , but most studies generally seem to exclude a direct impact of sexual activity on athletic aerobic and strength performance .
The most important aspect seems to be the interval from the time of the sports competition that affects negatively the performance if it is shorter than 2 h. There are possible negative effects from some possible concurrent wrong behaviors such as smoking or alcohol abuse .
There are no investigations about the effect of masturbation in this context . |
MS210941 | ***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 e18015 Background : Significant advances in the systemic management of metastatic non-small cell lung cancer ( NSCLC ) have occurred over the past decade , with options now including multiple lines of chemotherapy , EGFR inhibitors , and anti-angiogenic agents . Improvements in overall survival have been demonstrated in r and omized controlled trials comparing these newer agents to best supportive care ( BSC ) or st and ard therapy . This study examined uptake of these therapies in general practice and their impact on survival . METHODS This retrospective cohort study compared demographic , treatment and survival data among 987 patients diagnosed with stage IV NSCLC at two institutions in 1998 , 2003 , and 2008 . Cohorts were selected based on intervals when doublet chemotherapy , second line chemotherapy , and targeted agents were incorporated into the st and ard treatment regimen . RESULTS The proportion of patients receiving systemic therapy increased over time ( 20 % in 1998 , 42 % in 2008 ) . Treated patients diagnosed in 2008 were more likely to receive ≥2 lines of systemic therapy ( 60 % vs. 7 % in 1998 ) . Overall survival improved significantly across cohorts ( P < 0.001 ) , with 2 year survival rates of 0.3 % in 1998 , 4 % in 2003 , and 15 % in 2008 . After controlling for other variables , risk of death was diminished by 55 % in patients receiving 1 line of systemic therapy and 72 % in those receiving ≥2 lines , compared with BSC alone . Elderly patients ( age ≥70 years ) were also more likely to receive systemic therapy over time , with improved overall survival ( P < 0.001 ) . CONCLUSIONS Over the past decade , there has been increased use of systemic therapy in stage IV NSCLC patients , including the elderly . This has been associated with significantly improved overall survival Bisphophonates are the treatment of choice to prevent skeletal events in patients with multiple myeloma . Some pre clinical studies suggested that bisphophonates can be useful as antitumor drugs in some malignancies . We conducted a controlled clinical trial to assess if zoledronic acid can have this clinical activity . Ninetyfour patients with previously untreated multiple myeloma were treated with a conventional chemotherapy program : cyclophosphamide , vincristine , melphalan , and prednisone ( CVMP ) and were r and omized to received either zoledronic acid ( 4 mg , iv , every 28 d ) or not ( control group ) . The end-point of the present study was to assess improvement in outcome , measured by event-free survival ( EFS ) and overall survival ( OS ) , and the second-end point was to confirm the efficacy in preventing skeletal events . In an intent-to-treat analysis , all patients were available for efficacy and toxicity . Median follow up was 49.6 mo ( range : 34–72 mo ) . Five year actuarial curves showed that EFS was 80 % in the zoledronic acid group , which was statistically different from 52 % in the control group ( p < 0.01 ) . Actuarial 5 yr OS was 80 % in the zoledronic acid arm , and 46 % in the control group ( p < 0.01 ) . Sketeletal events were more frequent in the control group when compared to zoledronic acid . Toxicity was mild . We confirm the efficacy of zoledronic acid to prevent skeletal events , but we felt that we can demonstrate that zoledronic acid has a clinical antitumor effect measured from a increase in complete response rate and EFS and OS that were better when compared with the control group . We began a controlled clinical trial with modern treatment ( including transplant procedures ) in combination with zoledronic acid to define the role of zoledonic acid in this setting of patients Summary Background Bisphosphonates reduce the risk of skeletal events in patients with malignant bone disease , and zoledronic acid has shown potential anticancer effects in pre clinical and clinical studies . We aim ed to establish whether bisphosphonates can affect clinical outcomes in patients with multiple myeloma . Methods Patients of age 18 years or older with newly diagnosed multiple myeloma were enrolled from 120 centres in the UK . Computer-generated r and omisation sequence was used to allocate patients equally , via an automated telephone service , to receive 4 mg zoledronic acid as an infusion every 3–4 weeks or 1600 mg oral clodronic acid daily . Patients also received intensive or non-intensive induction chemotherapy . No investigators , staff , or patients were masked to treatment allocation , and bisphosphonate and maintenance therapy continued at least until disease progression . The primary endpoints were overall survival , progression-free survival , and overall response rate . We assessed between-group differences with Cox proportional hazards models for progression-free survival and overall survival , and with logistic regression models for overall response rate . Analysis was by intention to treat . This trial is registered , number IS RCT N68454111 . Findings 1970 patients were enrolled between May , 2003 , and November , 2007 , of whom 1960 were eligible for intention-to-treat analysis : 981 in the zoledronic acid group ( 555 on intensive chemotherapy , 426 on non-intensive chemotherapy ) ; and 979 on clodronic acid ( 556 on intensive chemotherapy , 423 on non-intensive chemotherapy ) . The treatment cutoff was Oct 5 , 2009 , with patients receiving bisphosphonates for a median of 350 days ( IQR 137–632 ) before disease progression , with a median of 3·7 years ' follow-up ( IQR 2·9–4·7 ) . Zoledronic acid reduced mortality by 16 % ( 95 % CI 4–26 ) versus clodronic acid ( hazard ratio [ HR ] 0·84 , 95 % CI 0·74–0·96 ; p=0·0118 ) , and extended median overall survival by 5·5 months ( 50·0 months , IQR 21·0 to not reached vs 44·5 months , IQR 16·5 to not reached ; p=0·04 ) . Zoledronic acid also significantly improved progression-free survival by 12 % ( 95 % CI 2–20 ) versus clodronic acid ( HR 0·88 , 95 % CI 0·80–0·98 ; p=0·0179 ) , and increased median progression-free survival by 2·0 months ( 19·5 months , IQR 9·0–38·0 vs 17·5 months , IQR 8·5–34·0 ; p=0·07 ) . Rates of complete , very good partial , or partial response did not differ significantly between the zoledronic acid and clodronic acid groups for patients receiving intensive induction chemotherapy ( 432 patients [ 78 % ] vs 422 [ 76 % ] ; p=0·43 ) or non-intensive induction chemotherapy ( 215 [ 50 % ] vs 195 [ 46 % ] ; p=0·18 ) . Both bisphosphonates were generally well tolerated , with similar occurrence of acute renal failure and treatment-emergent serious adverse events , but zoledronic acid was associated with higher rates of confirmed osteonecrosis of the jaw ( 35 [ 4 % ] ) than was clodronic acid ( 3 [ < 1 % ] ) . Interpretation Consistent with the potential anticancer activity of zoledronic acid , overall survival improved independently of prevention of skeletal-related events , showing that zoledronic acid has treatment benefits beyond bone health . These findings support immediate treatment with zoledronic acid in patients with newly diagnosed multiple myeloma , not only for prevention of skeletal-related events , but also for potential antimyeloma benefits . Funding Medical Research Council ( London , UK ) , with unrestricted educational grants from Novartis , Schering Health Care , Chugai , Pharmion , Celgene , and Ortho Biotech Objective Questions remain regarding the optimal use of bone-targeted agents in patients with metastatic bone disease . The purpose of this study was to assess current clinical practice regarding the use and administration of bone-targeted agents by Canadian oncologists in patients with metastatic breast and prostate cancer . Methods A survey was design ed to explore ; bone-targeted agent use in metastatic bone disease , variability in the choice and the frequency of administration of these agents . Opinions were sought on potential outcomes for future trials . Results A total of 193 clinicians were contacted and 90 completed our survey ( response rate 49 % after adjustment for inactivity ) . Survey respondents were medical oncologists ( 71.1 % ) , radiation oncologists ( 21.1 % ) and urologists ( 7.8 % ) . The findings suggest that once bone-targeted agents are started they are rarely discontinued . More agents are used in breast cancer than in prostate cancer . There was considerable interest in performing studies of de-escalated therapy in both breast and prostate cancer . Physicians requested ( 86 % ) that the primary study endpoint be the occurrence of skeletal related events and not biomarker driven . Conclusions Despite clinical practice guidelines and widespread use , significant areas of clinical equipoise with respect to use of bone-targeted agents exist . Findings from this survey suggest that physicians are interested in de-escalated therapy for both breast and prostate patients . However , the use of multiple agents in breast cancer and the desire for skeletal related events to be the primary endpoint means that very large r and omized studies will be required The aim of this open‐label , multicenter , r and omized phase II trial was to evaluate the efficacy and safety of zoledronic acid in combination with docetaxel in previously treated patients with non‐small‐cell lung cancer ( NSCLC ) and bone metastases . In this study , patients r and omly received docetaxel ( 60 mg/m2 ) with ( group DZ ) or without ( group D ) zoledronic acid every 21 days . There were 50 patients in each group , and the primary endpoint was progression‐free survival . In an efficacy analysis of 94 patients ( DZ , 48 ; D , 46 ) , the median progression‐free survival was 2.7 months ( 95 % confidence interval [ CI ] , 1.5–3.5 months ) for the DZ group and 2.6 months ( 95 % CI , 1.5–3.4 months ) for the D group ( stratified log‐rank test , P = 0.89 ) . The median overall survival was 10.4 months ( 95 % CI , 7.0–15.8 months ) for the DZ group and 9.7 months ( 95 % CI , 6.1–12.5 months ) for the D group ( stratified log‐rank test , P = 0.62 ) . There were no clinical ly relevant differences in the frequencies of grade 3 or 4 adverse events between the two groups . No treatment‐related deaths occurred in the DZ group . Zoledronic acid combined with docetaxel was well tolerated but did not meet the primary endpoint of demonstrating a longer progression‐free survival in advanced NSCLC patients with bone metastases compared with docetaxel alone . This trial was registered with the University Hospital Medical Information Network ( UMIN000001098 ) Men with prostate cancer are at high risk of developing bone metastases that can lead to clinical ly significant skeletal morbidity . Recently , a r and omized , placebo-controlled , phase III trial in 422 men with hormone-refractory prostate cancer and bone metastases demonstrated that zoledronic acid ( 4 mg every 3 weeks ) significantly reduced the incidence and onset of skeletal complications and provided significant long-term reductions in bone pain compared with placebo . Patients received zoledronic acid for a 15-month core phase , with the option to continue therapy for 9 more months on the extension phase . To evaluate the continuing benefit of long-term zoledronic acid therapy , retrospective exploratory analyses were conducted based on the incidence of skeletal-related events ( SREs ; defined as pathologic bone fracture , spinal cord compression , surgery or radiation therapy to bone , or change in antineoplastic therapy for bone pain ) occurring only during the extension phase of this trial . Quality of life parameters included assessment with the Brief Pain Inventory . Similar to results reported for the 15-month core phase and the entire 24-month study , the 9-month extension phase demonstrated that zoledronic acid significantly reduced the percentage of patients with an SRE ( P = 0.017 ) , prolonged the median time to first SRE ( P = 0.036 ) , reduced the annual incidence of SREs by 52 % ( P = 0.016 ) , and reduced the risk of SREs by 53 % ( P = 0.022 ) compared with placebo . Furthermore , zoledronic acid was safe and well tolerated . Therefore , zoledronic acid provides long-term continuing clinical benefit for men with prostate cancer and bone metastases and represents a new therapeutic option for this population PURPOSE Cisplatin plus gemcitabine is a st and ard regimen for first-line treatment of advanced non-small-cell lung cancer ( NSCLC ) . Phase II studies of pemetrexed plus platinum compounds have also shown activity in this setting . PATIENTS AND
Output:
| Study -specific results suggested that bone-modifying agents reduce the incidence of SREs and bone pain in lung cancer patients .
Data from included trials suggests benefit of bone-targeted agents in lung cancer for the prevention of SREs and bone pain . |
MS210942 | ***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 purpose of this study was to examine the behavioural and cognitive effects of selegiline in a group of moderately behaviourally disturbed AD patients Background : Short-term studies of L-deprenyl in Alzheimer 's disease ( AD ) suggest a beneficial effect , whereas longer-term studies are less convincing . Accordingly , we undertook a 6-month , r and omized , double-blind , placebo-controlled clinical trial to assess the potential benefit of L-deprenyl in AD . Methods : Sixty subjects were assigned to L-deprenyl ( 10 mg daily ) or placebo . After 4 weeks of single-blind placebo , 51 subjects entered the double-blind phase . The Brief Psychiatric Rating Scale ( BPRS ) was the primary outcome measure . Secondary outcome measures were the Mini-Mental State Examination , Global Deterioration Scale , Alzheimer 's Disease Assessment Scale ( noncognitive ) , Cornell Scale for Depression in Dementia , Buschke Selective Reminding Test(BSRT ) , Relative 's Assessment of Global Symptomatology-Elderly ( RAGS-E ) , Controlled Oral Word Association Test , and Modified Continuous Performance Test . In addition , several exploratory tasks were included for future hypothesis testing . Results : We found no significant differences between the L-deprenyl and placebo groups on the primary or secondary measures . However , several measures appeared to be sensitive to change over time , including the total score on the BPRS and some of its components as well as parts of the BSRT and the RAGS-E. Conclusion : Oral L-deprenyl provides no detectable benefit on general behavior , neuropsychiatric symptoms , or cognitive function in AD after 6 months of treatment . Protocol s for future drug studies should utilize measures that are sensitive to change over time such as the BPRS Although the central cholinergic deficits are still considered to be of primary importance in Alzheimer 's disease , there is great need for an expansion of the pharmacological approach in this illness beyond the simple cholinergic replacement hypothesis . This report focuses on the concept of " combination chemotherapy " in Alzheimer 's disease as the next generation of therapeutic strategies . Based on earlier positive findings in Alzheimer patients with the monoamine oxidase B inhibitor , 1-deprenyl , the authors speculate that a combination of physostigmine , the short-acting cholinesterase inhibitor , and 1-deprenyl might be more beneficial than either agent alone . The authors outline a sample paradigm for such combination studies , report preliminary data on the first 16 Alzheimer subjects to have received an initial combination of physostigmine and deprenyl , and point to other possible " combination chemotherapy " strategies for future study In a double blind r and omized crossover trial lasting 6 months selegiline , a selective MAO-B inhibitor , was tested against placebo for activity on verbal memory performances in Alzheimer-type dementia ( DAT ) . Verbal memory was assessed with the Rey-Auditory-Verbal Learning Test at the start of treatment , at the time scheduled for crossover ( 90 days ) and at the end of the trial ( 180 days ) . The results suggest that selegiline possesses significant activity on some memory parameters , which seems to depend on an improvement both in information processing abilities and in learning strategies at the moment of acquisitionSommarioIn uno studio doppio cieco cross-over , r and omizzato verso placebo della durata di sei mesi , è stata analizzata l'influenza della selegilina , inibitore selettivo delle MAO-B , sulle prestazioni di memoria verbale di 22 pazienti con diagnosi clinica di demenza tipo Alzheimer ( DAT ) . L'esame della memoria verbale è stato effettuato con il Rey-Auditory Verbal Learning test all'inizio del trattamento , dopo 90 giorni , momento previsto per il cross-over , e dopo 180 giorni , al termine della sperimentazione . I risultati suggeriscono una significativa efficacia della selegilina su alcuni parametri di memoria , che sembrano riconducibili ad un miglioramento sia delle capacità di elaborazione delle informazioni , sia delle strategie di apprendimento al momento dell'acquisizione The present study evaluated the safety of and obtained preliminary data on the cognitive effects of L-deprenyl and physostigmine in patients with Alzheimer 's Disease . Seventeen out patients with Alzheimer 's Disease participated in a double-blind crossover study in which they received 4 weeks of L-deprenyl at a dose of 10 mg p.o . , q.d . , and 4 weeks of placebo in r and om order . During both the L-deprenyl and placebo periods , patients received cognitive assessment s during physostigmine ( 0.5 mg ) and placebo infusions separated by 2 days . The cognitive effects of these agents alone and in combination were measured with digit span , verbal fluency , list learning , praxis , delayed recall , and delayed recognition tasks . Fifteen patients completed the study . The two drugs , used alone or in combination , were safe and well tolerated . Analyses of variance demonstrated that neither physostigmine nor L-deprenyl , whether given alone or in combination , significantly improved cognition , when compared with the double placebo condition The efficacy and tolerability of the monoamine oxidase B inhibitor selegiline and of the nootropic agent oxiracetam were compared in a single-blind , controlled , parallel study . The trial involved 22 men and 18 women with mild-to-moderate senile and presenile dementia of the Alzheimer type . The treatments were administered for 90 consecutive days as follows : one 10-mg selegiline tablet once daily and one 800-mg oxiracetam tablet twice daily . Efficacy was evaluated by means of a complex battery of neuropsychological tests , administered monthly for three months , starting from baseline . Safety was evaluated by monitoring adverse drug reactions as well as any pathological changes in hematology , blood chemistry , or liver and kidney function , measured at baseline and again at the conclusion of the study . Analysis of the results demonstrates that , at the dosage used , selegiline is more effective than oxiracetam in improving higher cognitive functions and reducing impairment in daily living . In particular , short- and long-term memory , sustained concentration , attention , verbal fluency , and visuospatial abilities were , for the most part , positively affected by selegiline . Gastroenteric and systemic tolerability of both drugs was also very good Ten patients diagnosed as affected by primary degenerative dementia of the Alzheimer type , with a mild to moderate cognitive and behavioral impairment , were studied in a double blind design when taking for 60 days 5 mg twice a day of L-deprenyl or placebo . Cognitive functions and cerebral blood flow were assessed at the beginning and at the end of treatment by a wide array of memory , attention , and language efficiency measures and by SPECT-99TcHMPAO procedure . Reduced CBF on the parietal lobes was demonstrated in the patients at baseline together with a reduction of memory and cognitive efficiency . At the end of the treatment patients who received L-deprenyl showed an improvement in cognitive efficiency and no changes in CBF , while patients treated with placebo showed a worsening of cognitive efficiency and further reduction of parietal lobe CBF BACKGROUND There is evidence that medications or vitamins that increase the levels of brain catecholamines and protect against oxidative damage may reduce the neuronal damage and slow the progression of Alzheimer 's disease . METHODS We conducted a double-blind , placebo-controlled , r and omized , multicenter trial in patients with Alzheimer 's disease of moderate severity . A total of 341 patients received the selective monoamine oxidase inhibitor selegiline ( 10 mg a day ) , alpha-tocopherol ( vitamin E , 2000 IU a day ) , both selegiline and alpha-tocopherol , or placebo for two years . The primary outcome was the time to the occurrence of any of the following : death , institutionalization , loss of the ability to perform basic activities of daily living , or severe dementia ( defined as a Clinical Dementia Rating of 3 ) . RESULTS Despite r and om assignment , the baseline score on the Mini-Mental State Examination was higher in the placebo group than in the other three groups , and this variable was highly predictive of the primary outcome ( P<0.001 ) . In the unadjusted analyses , there was no statistically significant difference in the outcomes among the four groups . In analyses that included the base-line score on the Mini-Mental State Examination as a covariate , there were significant delays in the time to the primary outcome for the patients treated with selegiline ( median time , 655 days ; P=0.012 ) , alpha-tocopherol ( 670 days , P=0.001 ) or combination therapy ( 585 days , P=0.049 ) , as compared with the placebo group ( 440 days ) . CONCLUSIONS In patients with moderately severe impairment from Alzheimer 's disease , treatment with selegiline or alpha-tocopherol slows the progression of disease The potential efficacy of oral l-deprenyl ( 5 mg b.i.d . ) added to the regimen of 10 patients with Alzheimer 's disease receiving either tacrine or physostigmine was assessed in a double-blind , placebo-controlled , 4-week , two-period crossover pilot study . l-Deprenyl was associated with significant improvement in scores on the cognitive subscale of the Alzheimer 's Disease Assessment Scale , suggesting possible additive effects of l-deprenyl to the effects of cholinesterase inhibitors Controlled clinical trials of the treatment of acute myocardial infa rct ion offer a unique opportunity for the study of the potential influence on outcome of bias in treatment assignment . A group of 145 papers was divided into those in which the r and omization process was blinded ( 57 papers ) , those in which it may have been unblinded ( 45 papers ) , and those in which the controls were selected by a nonr and om process ( 43 papers ) . At least one prognostic variable was maldistributed ( P less than 0.05 ) in 14.0 per cent of the blinded-r and omization studies , in 26.7 per cent of the unblinded-r and omization studies , and in 58.1 per cent of the nonr and omized studies . Differences in case-fatality rates between treatment and control groups ( P less than 0.05 ) were found in 8.8 per cent of the blinded-r and omization studies , 24.4 per cent of the unblinded-r and omization studies , and 58.1 per cent of the nonr and omized studies . These data emphasize the importance of keeping those who recruit patients for clinical trials from suspecting which treatment will be assigned to the patient under consideration BACKGROUND Currently there is no regimen for managing the inappropriate behavior seen in Alzheimer 's disease that does not cause significant patient sedation . Preliminary evidence suggests selegiline may be effective in behavioral modification without the adverse effects observed with other regimens . The purpose of this study was to document the efficacy of selegiline in Alzheimer 's patients with behavior problems . METHOD Eight Alzheimer 's patients ( 6 women and 2 men ) ranging in age from 50 to 82 years ( mean + /- SD = 74.0 + /- 10.5 ) were enrolled in this single-blind study . Patients received selegiline 10 mg each day for 8 weeks . Prior to drug administration and at the end of Weeks 1 , 2 , 4 , 6 , and 8 , patients were evaluated for behavior ( BEHAVEAD ) , cognitive function ( Mini-Mental State Examination ) , and caregiver stress ( Caregiver Burden Scale ) . RESULTS Of eight enrolled patients , five were available for analysis . No statistically significant differences were found between mean baseline and mean 8-week scores for any of the three tests . However , clinical significance was noted by improvement in cognition ( orientation and recall ) , caregiver stress , and behavior . Behavior was noted to improve in the areas of paranoid and delusional ideation , hallucinations , activity disturbances , anxiety , and phobias . CONCLUSION These data suggest that some Alzheimer 's patients with behavior problems may benefit from selegiline therapy This report describes the rationale and design of a clinical trial using selegiline ( 10 mg/day ) and alpha-tocopherol ( 2,000 IU/day ) to slow the progression of dementia in Alzheimer disease ( AD ) . This study was developed by the Alzheimer 's Disease Cooperative Study ( ADCS ) , a consortium of clinical research centers actively involved in AD research . The major goal of the consortium is to design and conduct clinical investigations leading to the development of treatments for AD . This study uses a r and omized double-blind , placebo-controlled , 2 x 2 factorial , parallel group design to test two drugs for the treatment of AD . The primary outcome of the study is the time to reach any one of the following four endpoints : death , institutionalization , loss of two of three basic activities of daily living , and progression of Clinical Dementia Rating ( CDR ) stage from 2 to 3 . Patients with moderately severe disease ( CDR = 2 ) were enrolled and evaluated 10 times over a period of 2 years to determine if these agents reduce the time to reach any endpoint . A data base from the Consortium to Establish a Registry for Alzheimer 's Disease indicated adequate power analyses to observe a treatment effect on this clinical ly meaningful outcome measure . Recruitment and baseline characteristics of the population are provided . The rationale for the choice
Output:
| The meta-analyses of emotional state show no treatment effects .
REVIEW ER 'S CONCLUSIONS Despite its initial promise , ie the potential neuroprotective properties , and its role in the treatment of Parkinson 's disease sufferers , selegiline for Alzheimer 's disease has proved disappointing .
Although there is no evidence of a significant adverse event profile , there is also no evidence of a clinical ly meaningful benefit for Alzheimer 's disease sufferers .
This is true irrespective of the outcome measure evaluated , ie cognition , emotional state , activities of daily living , and global assessment , whether in the short , or longer term ( up to 69 weeks ) , where this has been assessed .
There would seem to be no justification , therefore , to use it in the treatment of people with Alzheimer 's disease , nor for any further studies of its efficacy in Alzheimer 's disease |
MS210943 | ***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 Numerous studies have shown that women undergoing coronary revascularization procedures do so at a higher risk for an adverse outcome compared with men . However , the impact of advances in technology and improvements in techniques on in-hospital and long-term outcome after revascularization in women is unclear . METHODS AND RESULTS We evaluated 1829 patients with symptomatic multivessel coronary disease r and omized to CABG or PTCA in the Bypass Angioplasty Revascularization Investigation ( BARI ) , of whom 27 % were women . As expected , women were older ( 64.0 versus 60.5 years ) , with more congestive heart failure ( 14 % versus 7 % ) , hypertension ( 68 % versus 42 % ) , treated diabetes mellitus ( 31 % versus 15 % ) , and unstable angina ( 67 % versus 61 % ) than men but had similar preservation of left ventricular function and extent of multivessel disease . Women assigned to surgery received the same number of total grafts but fewer internal mammary artery grafts ( 72 % versus 85 % , P<0 . 01 ) , and those assigned to angioplasty had more intended lesions ( 76 % versus 71 % , P<0.01 ) successfully dilated than men . At an average of 5.4 years ' follow-up , crude mortality rates were similar in women ( 12.8 % ) and men ( 12.0 % ) . The Cox regression model adjusting for baseline differences revealed that women had a significantly lower risk of death ( relative risk , 0.60 ; 95 % CI , 0.43 to 0.84 ; P=0 . 003 ) but not a significantly lower risk of death plus myocardial infa rct ion ( relative risk , 0.84 ; 95 % CI , 0.66 to 1.07 ; P=0.16 ) than men . CONCLUSIONS Although the unadjusted mortality rate suggests that women and men undergoing CABG and PTCA have a similar 5-year mortality , women have higher risk profiles ; consequently , contrary to previous reports , female sex is an independent predictor of improved 5-year survival after we control for multiple risk factors BACKGROUND Blockade of the platelet glycoprotein IIb/IIIa receptor with abciximab ( a monoclonal-antibody Fab fragment directed against the receptor ) has been shown to diminish ischemic complications among patients undergoing high-risk coronary angioplasty or directional atherectomy but increases bleeding complications . The widespread applicability of this treatment is unknown , particularly in view of the observed risk of hemorrhage . METHODS In a prospect i ve , double-blind trial , we r and omly assigned patients undergoing urgent or elective percutaneous coronary revascularization at 69 centers to receive abciximab with st and ard-dose , weight-adjusted heparin ( initial bolus of 100 U per kilogram of body weight ) ; abciximab with low-dose , weight-adjusted heparin ( initial bolus of 70 U per kilogram ) ; or placebo with st and ard-dose , weight-adjusted heparin . The primary efficacy end point was death from any cause , myocardial infa rct ion , or urgent revascularization within 30 days of r and omization . RESULTS The trial was terminated at the first interim analysis , with 2792 of the planned 4800 patients enrolled . At 30 days , the composite event rate was 11.7 percent in the group assigned to placebo with st and ard-dose heparin ; 5.2 percent in the group assigned to abciximab with low-dose heparin ( hazard ratio , 0.43 ; 95 percent confidence interval , 0.30 to 0.60 ; P<0.001 ) ; and 5.4 percent in the group assigned to abciximab with st and ard-dose heparin ( hazard ratio , 0.45 ; 95 percent confidence interval , 0.32 to 0.63 ; P<0.001 ) . There were no significant differences among the groups in the risk of major bleeding , although minor bleeding was more frequent among patients receiving abciximab with st and ard-dose heparin . CONCLUSIONS Inhibition of the platelet glycoprotein IIb/IIIa receptor with abciximab , together with low-dose , weight-adjusted heparin , markedly reduces the risk of acute ischemic complications in patients undergoing percutaneous coronary revascularization , without increasing the risk of hemorrhage OBJECTIVE The quality of target vessels may affect gender differences in outcome after coronary artery bypass grafting . This prospect i ve study compares preoperative angiographic assessment of vessel quality with intraoperative visual assessment of size and presence or absence of diffuse disease . The effect of vessel quality on operative mortality and late survival is examined . METHODS Data were prospect ively collected on 1939 consecutive patients undergoing isolated coronary artery bypass grafting by a single surgeon . Quality of target vessels was assessed preoperatively ( angiogram ) and intraoperatively by inspection and probe calibration . RESULTS Vessels were poorly visualized in 29 % of female patients and 37 % of male patients ( P = .004 ) , although all but 1.6 % of target vessels were grafted . Women were no more likely than men to have small vessels ( < 1.5 mm ) ( 57 % vs 59 % , P = .449 ) and were less likely to have distal disease ( 45 % vs 53 % , P = .005 ) . Operative mortality was low , not statistically different in women versus men ( 1.3 % vs 0.7 % , P = .237 ) , and increased in patients with distal disease ( 1.3 % vs.03 % , P = .021 ) . Late survival was decreased in patients with poor left ventricle function , congestive heart failure , and peripheral vascular disease . Late survival was decreased in men with increased age , class IV symptoms , small size , and no left internal thoracic artery graft , and in women with recent myocardial infa rct ion and preoperative cerebrovascular accident . CONCLUSION We conclude that in most patients with poorly visualized vessels in the preoperative angiogram , complete revascularization can be achieved if one is willing to graft small or diffusely diseased vessels . Women are no more likely than men to have vessels less than 1.5 mm in size and are less likely to have diffuse disease . Such an approach is associated with a low operative mortality and good long-term survival . Predictors of late survival were different for men and women . Neither small vessel size nor diffuse disease was an independent predictors of poor late outcome Background —Women with acute myocardial infa rct ion ( AMI ) undergoing primary angioplasty have higher rates of morbidity and mortality than do men . Whether contemporary interventional treatment strategies have improved outcomes for women compared with men is unknown . Methods and Results —In the CADILLAC trial , 2082 patients ( 27 % women ) with AMI within 12 hours of symptom onset were r and omized to balloon angioplasty ( PTCA ; n=518 ) , PTCA+abciximab ( n=528 ) , stenting ( n=512 ) , and stenting+abciximab ( n=524 ) . As compared with men , women had a lower body surface area ; had a greater prevalence of diabetes , hypertension , and hyperlipidemia ; experienced significant delays to treatment ; and had better baseline and final TIMI grade 3 flows . Unadjusted 1-year event rates were higher for women , including death ( 7.6 % versus 3.0 % , P<0.001 ) , ischemic target-vessel revascularization ( TVR ; 16.7 % versus 12.1 % , P=0.006 ) , and major adverse cardiac events ( MACE ; 23.9 % versus 15.3 % , P<0.001 ) . Female gender was an independent predictor of MACE and bleeding complications , although comorbid risk factors and body surface area but not gender predicted 1-year death . For women , primary stenting result ed in a reduction in 1-year MACE from 28.1 % to 19.1 % ( P=0.01 ) and in ischemic TVR from 20.4 % to 10.8 % ( P=0.002 ) compared with PTCA . The addition of abciximab to primary stenting significantly reduced the 30-day ischemic TVR without increasing bleeding or stroke rates . Conclusions —The higher mortality rate in women compared with men after interventional treatment for AMI may be explained by differences in body size and clinical risk factors , although female gender remains an important independent determinant of overall adverse outcomes . For women in the CADILLAC trial , the addition of abciximab reduced 30-day TVR without increasing bleeding risk , and primary stenting reduced 1-year TVR and MACE rates compared with PTCA Background —Although most r and omized clinical trials have suggested that long-term survival rates after percutaneous coronary intervention ( PCI ) or surgical multivessel coronary revascularization ( CABG ) are equivalent , some post hoc analyses in high-risk groups and adjustment for severity of coronary disease have suggested higher mortality after PCI . Methods and Results —We studied 6033 consecutive patients who underwent revascularization in the late 1990s . PCI was performed in 872 patients ; 5161 underwent CABG . Half the patients had significant left ventricular dysfunction or diabetes . Propensity analysis to predict the probability of undergoing PCI according to 22 variables and their interactions was used . The C-statistic for this model was 0.90 , indicating excellent discrimination between treatments . There were 931 deaths during 5 years of follow-up . The 1- and 5-year unadjusted mortality rates were 5 % and 16 % for PCI and 4 % and 14 % for CABG ( unadjusted hazard ratio , 1.13 ; 95 % CI , 1.0 to 1.4 ; P = 0.07 ) . PCI was associated with an increased risk of death ( propensity-adjusted hazard ratio , 2.3 ; 95 % CI , 1.9 to 2.9 ; P < 0.0001 ) . This difference was observed across all categories of propensity for PCI and in patients with diabetes or left ventricular dysfunction . Other independent predictors of mortality ( P ≤0.01 for all ) were renal dysfunction , age , diabetes mellitus , chronic lung disease , peripheral vascular disease , left main trunk stenosis , and extent of coronary disease ( Duke angiographic score ) . Conclusions —In patients with multivessel coronary artery disease and many high-risk characteristics , CABG was associated with better survival than PCI after adjustment for risk profile Background —The effectiveness of sirolimus-eluting stents in unselected patients treated in the daily practice is currently unknown . Methods and Results —Sirolimus-eluting stent implantation has been used as the default strategy for all percutaneous procedures in our hospital as part of the R apamycin-E luting S tent E valuated A t R otterdam C ardiology H ospital ( RESEARCH ) registry . Consecutive patients with de novo lesions ( n=508 ) treated exclusively with sirolimus-eluting stents ( SES group ) were compared with 450 patients who received bare stents in the period just before ( pre-SES group ) . Patients in the SES group more frequently had multivessel disease , more type C lesions , received more stents , and had more bifurcation stenting . At 1 year , the cumulative rate of major adverse cardiac events ( death , myocardial infa rct ion , or target vessel revascularization ) was 9.7 % in the SES group and 14.8 % in the pre-SES group ( hazard ratio [ HR ] , 0.62 [ 95 % CI , 0.44 to 0.89 ] ; P = 0.008 ) . The 1-year risk of clinical ly driven target vessel revascularization in the SES group and in the pre-SES group was 3.7 % versus 10.9 % , respectively ( HR , 0.35 [ 95 % CI , 0.21 to 0.57 ] ; P < 0.001 ) . Conclusions —Unrestricted utilization of sirolimus-eluting stents in the “ real world ” is safe and effective in reducing both repeat revascularization and major adverse cardiac events at 1 year compared with bare stent implantation BACKGROUND Coronary artery diameter is known to be inversely associated with perioperative mortality related to coronary artery bypass grafting ( CABG ) . This association is believed to be responsible for increased risk among women and smaller people . However , the associations between sex , body size , and coronary size have not been carefully examined because direct information about coronary size is rarely available . Also , whether sex has an independent effect on vessel size is largely unknown . METHODS AND RESULTS Height , weight , sex , age , status at hospital discharge , and luminal diameter of the midleft anterior descending coronary artery ( mid-LAD ) were recorded prospect ively in 1325 patients undergoing CABG . Small vessel size was associated with substantially increased risk of in-hospital mortality ( 15.8 % for 1.0-mm vessels , 4.6 % for 1.5- to 2.0-mm vessels , and 1.5 % for 2.5- to
Output:
| The majority of studies noted greater in-hospital mortality in women than in men , with mortality differences resolving with longer follow-up .
Early mortality differences were reduced but not consistently eliminated after adjustment for comorbidities , procedural characteristics , and body habitus .
Gender was an independent risk factor for complications after both CABG and PCI .
Women experience greater complications and early mortality after revascularization . |
MS210944 | ***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 compare outcome following in vitro fertilization-embryo transfer ( IVF-ET ) using controlled ovarian hyperstimulation ( COH ) regimens using either the gonadotropin-releasing hormone ( GnRH ) agonist leuprolide acetate vs the GnRH antagonist ganirelix . METHODS Women needing IVF for conception were r and omly assigned to 300 IU of gonadotropins with ganirelix used in the follicular phase when a follicle with a 14 mm average diameter was attained vs a regimen using leuprolide acetate from the mid-luteal phase of the previous cycle . RESULTS There were no differences found in clinical , ongoing , delivered pregnancy rates or implantation rates between groups . CONCLUSIONS The use of GnRH antagonists do not seem to reduce IVF outcome compared to using GnRH agonists in COH regimens OBJECTIVE Both gonadotropin-releasing hormone ( GnRH ) analogs and antagonists have been used for pituitary desensitization during controlled ovarian hyperstimulation ( COH ) . We aim ed to determine the minimum effective daily dose of GnRH antagonist in women undergoing COH . We also compared the efficiency of a GnRH antagonist and a GnRH agonist . MATERIAL S AND METHODS Women undergoing in vitro fertilization/intracytoplasmic sperm injection and embryo transfer were divided into five groups : ( 1 ) cetrorelix 0.25 mg ( n = 86 ) ; ( 2 ) cetrorelix 0.2 mg ( n = 28 ) ; ( 3 ) cetrorelix 0.15 mg ( n = 30 ) ; ( 4 ) leuprolide acetate ( LA ) 0.5 mg/day ( n = 58 ) ; ( 5 ) single half-dose LA depot 1.88 mg ( n = 49 ) . Cetrorelix was administered daily from menstrual day 8 until the day of human chorionic gonadotropin administration . LA or LA depot was started on day 21 of the previous menstrual cycle . RESULTS We observed lower gonadotropin ( Gn ) dosages , estradiol ( E2 ) levels and reduced risk of ovarian hyperstimulation syndrome ( OHSS ) in the GnRH antagonist groups . A higher risk of luteinizing hormone ( LH ) surge was noted in cetrorelix 0.2 and 0.15 mg groups . Gn dosages (IU)/E2 levels ( pg/mL ) in each group were : ( 1 ) 1,949.4/1,191.1 ; ( 2 ) 1,869.6/1,010.8 ; ( 3 ) 1,856.7/1,023.6 ; ( 4 ) 2,184.5/1,323.6 ; and ( 5 ) 2,103.5/1,313.5 , respectively . LH/OHSS risks were : ( 1 ) 3.5%/5.8 % ; ( 2 ) 7.1%/3.6 % ; ( 3 ) 13.3%/3.3 % ; ( 4 ) 3.4%/8.6 % ; and ( 5 ) 2%/8.2 % , respectively . Number of oocytes/embryos/ grade I , II embryos were : ( 1 ) 9.4/7.9/5.8 ; ( 2 ) 7.5/4.2/3.6 ; ( 3 ) 6.3/4.1/3.1 ; ( 4 ) 12.3/8.9/6.6 ; and ( 5 ) 11.8/8.4/6.1 , respectively . There was no significant difference in terms of clinical outcomes between groups 1 , 4 and 5 , except for higher abortion rates ( AR ) in group 1 . Pregnancy rate (PR)/implantation rate ( IR ) ratios in groups 1 , 4 , and 5 were statistically higher than those in groups 2 and 3 . Chemical PR/IR/AR were : ( 1 ) 30.2%/5.9%/7 % ; ( 2 ) 21.4%/5.1%/7.1 % ; ( 3 ) 16.7%/4.1%/10 % ; ( 4 ) 32.8%/5.5%/8.6 % ; and ( 5 ) 30.6%/5.7%/8.2 % , respectively . CONCLUSION The lowest effective dosage of cetrorelix for pituitary desensitization during COH luteolysis is 0.25 mg , result ing in a comparable PR but a higher AR when compared with GnRH agonist Purpose To evaluate the results of gonadotropin-releasing hormone agonist ( GnRHa ) and gonadotropin-releasing hormone antagonist ( GnRHant ) use in two demographically matched groups of normoresponder in-vitro fertilisation or intracytoplasmic sperm injection ( IVF/ICSI ) patients in a prospect i ve study . Methods We r and omised 93 patients undergoing IVF/ICSI between May 2005 and August 2006 . Patients with IVF indications were included except for those with polycystic ovary syndrome or azoospermia , women older than 38 years and those with follicle-stimulating hormone ( FSH ) ≥10 IU/ml . Patients were stimulated with st and ard 225 IU recombinant FSH . In Group I ( n=45 ) a daily dose of GnRHant cetrorelix acetate 0.25 mg was administered when follicles reached a diameter of ≥14 mm . Group II ( n=48 ) patients were desensitised with the GnRHa , leuprolide acetate , in a long protocol . Human chorionic gonadotropin ( hCG ) was administered when at least three follicles of 18 mm in diameter were observed . Oocyte retrieval was scheduled 36 hours following hCG administration and embryos were transferred on day 3 after oocyte retrieval . Results The two groups were homogenous for age , infertility duration , basal FSH and serum oestradiol ( E2 ) ( P=0.537 , P=0.911 , P=0.103 and P=0.733 , respectively ) . In Group II ( the GnRHa group ) more antral follicles ( P<0.001 ) , a longer induction duration ( P=0.017 ) and higher peak E2 levels ( P<0.001 ) were observed . No differences were observed in the number of oocytes retrieved ( P=0.749 ) , embryos achieved and transferred ( P=0.677 ) , or fertilisation rates ( P=0.839 ) between the two groups . There was no statistically significant difference between groups in clinical pregnancy rates , cycle cancellation and ovarian hyperstimulation ( P=0.437 , P=0.109 and P=0.415 , respectively ) . Conclusion GnRHant and GnRHa provide comparable results in normoresponder patients , while GnRHant allows a greater flexibility in their treatment OBJECTIVE To compare the effects of oral contraceptive ( OC ) pill pretreatment in recombinant FSH/GnRH-antagonist versus recombinant FSH/GnRH-agonist stimulation in in vitro fertilization ( IVF ) patients , and to evaluate optimization of retrieval day . DESIGN Prospect i ve , r and omized , multicenter study . SETTING Private practice and university centers . PATIENT(S ) Eighty patients undergoing IVF who met the appropriate inclusion criteria . INTERVENTION(S ) Four study centers recruited 80 patients . The OC regimen began on cycle days 2 to 4 and was discontinued on a Sunday after 14 to 28 days . The recombinant FSH regimen was begun on the following Friday . The GnRH-agonist group was treated with a long protocol ; the GnRH-antagonist was initiated when the lead follicle reached 12 to 14 mm . When two follicles had reached 16 to 18 mm , hCG was administered . MAIN OUTCOME MEASURE(S ) The primary outcome measures were the number of cumulus-oocyte complexes , day of the week for oocyte retrieval , and total dose and days of stimulation of recombinant FSH . Secondary efficacy variables included pregnancy and implantation rate ; serum E(2 ) levels on stimulation day 1 ; serum E(2 ) , P , and LH levels on the day of hCG administration ; follicle size on day 6 and day of hCG administration ; the total days of GnRH-analogue treatment ; total days on OC ; total days from end of OC to oocyte retrieval ; and the cycle cancellation rate . RESULT ( S ) Patient outcomes were similar for the days of stimulation , total dose of gonadotropin used , two-pronuclei embryos , pregnancy ( 44.4 % GnRH-antagonist vs. 45.0 % GnRH-agonist , P=.86 ) and implantation rates ( 22.2 % GnRH-antagonist vs. 26.4 % GnRH-agonist , P=.71 ) . Oral contraceptive cycle scheduling result ed in 78 % and 90 % of retrievals performed Monday through Friday for GnRH-antagonist and GnRH-agonist . A one day delay in OC discontinuation and recombinant FSH start would result in over 90 % of oocyte retrievals occurring Monday through Friday in both groups . CONCLUSION ( S ) The OC pretreatment in recombinant FSH/GnRH-antagonist protocol s provides a patient-friendly regimen and can be optimized for weekday retrievals . No difference was seen in number of 2PN embryos , cryopreserved embryos , embryos transferred , implantation and pregnancy rates between the two stimulation protocol STUDY QUESTION Is the risk of severe ovarian hyperstimulation syndrome ( OHSS ) similar in a short GnRH antagonist and long GnRH agonist protocol in first cycle IVF/ICSI patients less than 40 years of age ? . SUMMARY ANSWER There is an increased risk of severe OHSS in the long GnRH agonist group compared with the short GnRH antagonist protocol . WHAT IS KNOWN ALREADY ? : In the most recent Cochrane review , the GnRH antagonist protocol was associated with a similar live birth rate ( LBR ) , a similar on-going pregnancy rate ( OPR ) , and a lower incidence of OHSS ( odds ratio ( OR ) = 0.43 95 % confidence interval ( CI ) : 0.33 - 0.57 ) compared with the traditional GnRH agonist protocol . Previous trials comparing the two protocol s mainly included selected patient population s , a limited number of patients and the applied OHSS criteria differed , making direct comparisons difficult . In two recent large meta-analyses , no significant differences in LBR ( OR = 0.86 ; 95 % CI : 0.72 - 1.02 ) or in the incidence of severe OHSS were reported , while others found a lower LBR ( OR = 0.82 ; 95 % CI : 0.68 - 0.97 ) and a reduced risk of severe OHSS using the GnRH antagonist protocol ( OR = 0.60 ; 95 % CI : 0.40 - 0.88 ) . STUDY DESIGN , SIZE , DURATION Phase IV , dual-centre , open-label , RCT including 1050 women allocated to either short GnRH antagonist or long GnRH agonist protocol in a 1:1 ratio and enrolled over a 5-year period using a web-based concealed r and omization code . This is a superiority study design ed to detect a difference in severe OHSS , the primary outcome , between the two groups with a power of 80 % and stratified for age , assisted reproductive technology ( ART ) clinic and planned fertilization procedure ( IVF/ICSI ) . The secondary aims were to compare rates of mild and moderate OHSS , positive plasma (p)-hCG , on-going pregnancy and live birth between the two arms . None of the women had undergone previous ART treatment . PARTICIPANTS / MATERIAL S , SETTING , METHODS All infertile women referred for their first IVF/ICSI at two public fertility clinics , less than 40 years of age and with no uterine malformations were asked to participate . A total of 1099 subjects were r and omized , including women with poor ovarian reserve , polycystic ovary syndrome and irregular cycles . A total of 49 women withdrew their consent , thus 1050 subjects were allocated to the GnRH antagonist ( n = 534 ) and agonist protocol ( n = 516 ) , respectively . In total 1023 women started recombinant human follitropin-β ( rFSH ) stimulation , 528 in the GnRH antagonist group and 495 in the GnRH agonist group . All subjects were given a fixed rFSH dose of 150 IU or 225 IU according to age ≤36 years or > 36 years , with the option to adjust dose at stimulation day 6 . Clinical OHSS parameters were collected at oocyte retrieval , and Days 3 and 14 post-transfer . On-going pregnancy was determined by transvaginal ultrasonography at
Output:
| Stimulation days ( mean difference ( MD ) [ 95 % confidence interval ( CI ) ] = -0.8 [ -1.36 , -0.23 ] , P = 0.006 ) , gonadotrophin ( Gn ) dosage ( MD [ 95 % CI ] = -3.52 [ -5.56 , -1.48 ] , P = 0.0007 ) , estradiol ( E2 ) level on the day of human chorionic gonadotrophin ( HCG ) administration ( MD [ 95 % CI ] = -365.49 [ -532.93 , -198.05 ] , P<0.0001 ) , the number of oocytes retrieved ( MD [ 95 % CI ] = -1.41 [ -1.84 , -0.99 ] , P<0.00001 ) , the embryos obtained ( MD [ 95 % CI ] = -0.99 [ -1.38 , -0.59 ] , P<0.00001 ) , incidence of ovarian hyperstimulation syndrome ( OHSS ) ( OR [ 95 % CI ] = 0.69 [ 0.57 , 0.83 ] , P<0.0001 ) were statistically significantly lower in GnRH-ant protocol than GnRH-a long protocol .
GnRH-ant protocol substantially decreased the incidence of OHSS without influencing the pregnancy rate and live birth rate compared to GnRH-a long protocol among patients with normal ovarian reserve |
MS210945 | ***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 Case management is believed to promote continuity of care and decrease hospitalization rates , although few controlled trials have tested this approach . OBJECTIVE To assess the effectiveness of a st and ardized telephonic case-management intervention in decreasing re source use in patients with chronic heart failure . METHODS A r and omized controlled clinical trial was used to assess the effect of telephonic case management on re source use . Patients were identified at hospitalization and assigned to receive 6 months of intervention ( n = 130 ) or usual care ( n = 228 ) based on the group to which their physician was r and omized . Hospitalization rates , readmission rates , hospital days , days to first rehospitalization , multiple readmissions , emergency department visits , inpatient costs , outpatient re source use , and patient satisfaction were measured at 3 and 6 months . RESULTS The heart failure hospitalization rate was 45.7 % lower in the intervention group at 3 months ( P = .03 ) and 47.8 % lower at 6 months ( P = .01 ) . Heart failure hospital days ( P = .03 ) and multiple readmissions ( P = .03 ) were significantly lower in the intervention group at 6 months . Inpatient heart failure costs were 45.5 % lower at 6 months ( P = .04 ) . A cost saving was realized even after intervention costs were deducted . There was no evidence of cost shifting to the outpatient setting . Patient satisfaction with care was higher in the intervention group . CONCLUSIONS The reduction in hospitalizations , costs , and other re source use achieved using st and ardized telephonic case management in the early months after a heart failure admission is greater than that usually achieved with pharmaceutical therapy and comparable with other disease management approaches OBJECTIVES to investigate the effectiveness of a pharmacy discharge plan in elderly hospitalized patients . DESIGN r and omized controlled trial . SUBJECTS AND SETTING S we r and omized patients aged 75 years and older on four or more medicines who had been discharged from three acute general and one long-stay hospital to a pharmacy intervention or usual care . INTERVENTIONS the hospital pharmacist developed discharge plans which gave details of medication and support required by the patient . A copy was given to the patient and to all relevant professionals and carers . This was followed by a domiciliary assessment by a community pharmacist . In the control group , patients were discharged from hospital following st and ard procedures that included a discharge letter to the general practitioner listing current medications . OUTCOMES the primary outcome was re-admission to hospital within 6 months . Secondary outcomes included the number of deaths , attendance at hospital outpatient clinics and general practice and proportion of days in hospital over the follow-up period , together with patients ' general well-being , satisfaction with the service and knowledge of and adherence to prescribed medication . RESULTS we recruited 362 patients , of whom 181 were r and omized to each group . We collected hospital and general practice data on at least 91 and 72 % of patients respectively at each follow-up point and interviewed between 43 and 90 % of the study subjects . There were no significant differences between the groups in the proportion of patients re-admitted to hospital between baseline and 3 months or 3 and 6 months . There were no significant differences in any of the secondary outcomes . CONCLUSIONS we found no evidence to suggest that the co-ordinated hospital and community pharmacy care discharge plans in elderly patients in this study influence outcomes Abstract Objectives : To determine whether specialist nurse intervention improves outcome in patients with chronic heart failure . Design : R and omised controlled trial . Setting : Acute medical admissions unit in a teaching hospital . Participants : 165 patients admitted with heart failure due to left ventricular systolic dysfunction . The intervention started before discharge and continued thereafter with home visits for up to 1 year . Main outcome measures : Time to first event analysis of death from all causes or readmission to hospital with worsening heart failure . Results : 31 patients ( 37 % ) in the intervention group died or were readmitted with heart failure compared with 45 ( 53 % ) in the usual care group ( hazard ratio=0.61 , 95 % confidence interval 0.33 to 0.96).Compared with usual care , patients in the intervention group had fewer readmissions for any reason ( 86 v 114 , P=0.018 ) , fewer admissions for heart failure ( 19 v 45 , P<0.001 ) and spent fewer days in hospital for heart failure ( mean 3.43 v 7.46 days , P=0.0051 ) . Conclusions : Specially trained nurses can improve the outcome of patients admitted to hospital with heart failure . What is already known on this topic Studies have suggested that nurse intervention may reduce readmission in patients with heart failure What this study adds Home based intervention from nurses reduces readmissions for worsening heart failure Regular contact to review treatment and patient education are likely to contribute to this To select patients for early discharge planning , a r and omized clinical trial evaluated a protocol that used risk factors identified upon hospital admission . The goal of the study was to determine if intervention with high-risk patients could reduce the need for hospital admission or skilled care . Of 13,255 patients screened , 835 study participants were identified as " at risk " for frequent health care re source use . Half of the high-risk patients were r and omly assigned to the experimental group ( n=417 ) and received discharge planning from day 3 of their hospital stay , while the control group ( n=418 ) received discharge planning only if there was a written physician request . Those patients receiving early , systematic discharge planning experienced an increased likelihood of successful return to home after hospital admission and a decreased chance of unscheduled readmission for the 9-month study period . Length of the index hospital stay was not affected by early planning , however . The major clinical implication is the potential for discharge planners to decrease the need for , and use of , health care re sources after hospital admission OBJECTIVE To determine whether enhanced access to primary care affects the diagnostic evaluation , pharmacologic management , or health outcomes of patients hospitalized with congestive heart failure ( CHF ) . DESIGN Multisite r and omized , controlled trial . SETTING Nine Veterans Affairs medical centers . PATIENTS 443 patients who were hospitalized with a diagnosis of CHF . INTERVENTION Enhanced access to primary care , including assignment of a primary care nurse and physician , increased telephone contact , additional outpatient visits , and patient education . MAIN OUTCOME MEASURES Diagnostic evaluation , pharmacologic management , health-related quality of life , and hospital readmission rates . RESULTS About 80 % of patients who had enhanced access to care and patients receiving usual care underwent recommended evaluation of left ventricular ejection fraction . Among the subset of patients for whom an angiotensin-converting enzyme ( ACE ) inhibitor was recommended ( i.e. , ejection fraction < 40 % ) , three quarters of the patients in both the enhanced access and usual care groups received the drug ( 75 % vs. 73 % ; P > 0.2 ) . Enhanced access to primary care did not improve quality of life and increased hospital readmissions , with an average of 1.5 + /- SD 2.0 readmissions per 6 months of follow-up for patients who had enhanced access compared with 1.1 + /- SD 1.8 for those who received usual care ( P = 0.02 ) . CONCLUSIONS Compliance with recommended CHF testing and treatment guidelines was equally high in both study groups . Enhanced access to primary care did not improve patients ' self-reported health status and was associated with more frequent hospitalizations PURPOSE This work addresses the unanswered question of whether multidisciplinary care ( MDC ) of heart failure ( HF ) can reduce readmissions when optimal medical care is applied in both intervention and control groups . METHODS In a r and omized , controlled study , 98 patients ( mean age , 70.8 + /- 10.5 years ) admitted to hospital with left ventricular failure ( New York Heart Association Class IV ) were assigned to routine care ( RC , n = 47 ) or MDC ( n = 51 ) . All patients received the same components of inpatient , optimal medical care of HF : specialist-led inpatient care ; titration to maximum tolerated dose of angiotensin-converting enzyme inhibitor before discharge ; attainment of predetermined discharge criteria ( weight stable , off all intravenous therapy , and no change in oral regimen for 2 days ) . Only those in the MDC group received inpatient and outpatient education and close telephone and clinic follow-up . The primary study endpoint was rehospitalization or death for a HF-related issue at 3 months . MAIN FINDINGS At 3 months , four people had events in the MDC group ( 7.8 % rate over 3 months ) compared with 12 people ( 25.5 % rate over 3 months ) in the RC group ( P = 0.04 ) . CONCLUSION These data demonstrate for the first time the intrinsic benefit of MDC in the setting of protocol -driven , optimal medical management of HF . Moreover , the event rate of 7.8 % at 3 months , as the lowest reported rate for such a high-risk group , underlines the value of this approach to the management of heart failure PURPOSE Several r and omized trials have found that discharge planning improves outcomes for hospitalized patients . We do not know if adding a clinical nurse specialist ( CNS ) to physician teams in hospitals that already have discharge planning services makes a difference . METHODS In 2 teaching hospitals , patients were r and omly assigned to regular hospital care or care with a clinical nurse specialist . The clinical nurse specialist facilitated hospital care by retrieving preadmission information , arranging in-hospital consultations and investigations , organizing postdischarge follow-up visits , and checking up on patients postdischarge with a telephone call . In-hospital outcomes included mortality and length of stay . Postdischarge outcomes included time to readmission or death , patient satisfaction , and the risk of adverse event . Adverse events were poor outcomes due to medical care rather than the natural history of disease . RESULTS A total of 620 sequential patients were r and omized ( CNS n = 307 , control n = 313 ) , of which 361 were followed after discharge from hospital ( CNS n = 175 , control n = 186 ) . The groups were similar for the probability of in-hospital death ( CNS 9.3 % vs control 9.7 % ) or being discharged to the community ( 58.0 % vs 60.0 % ) . The groups did not differ for postdischarge outcomes including readmission or death ( 21.6 % vs 15.6 % ; P = 0.16 ) or risk of adverse event ( 23.6 % vs 22.8 % ) . Mean [ SD ] patient ratings of overall quality of care on a scale of 10 was higher in the clinical nurse specialist group ( 8.2 [ 2.2 ] vs 7.6 [ 2.4 ] ; P = 0.052 ) . CONCLUSION The addition of a clinical nurse specialist to a medical team improved patient satisfaction but did not impact hospital efficiency or patient safety OBJECTIVE To determine the impact of a hospital-coordinated discharge care plan , involving a multidisciplinary team of primary health care providers , on hospital length of stay , quality of life , and both patient and general practitioner inclusion in , and satisfaction with , discharge procedures . DESIGN This investigation comprised a prospect i ve , r and omized , controlled , clinical trial . SETTING This multicentre and cross-jurisdictional study focused on areas of tertiary and primary health care as well as community allied health in Western Australia . PARTICIPANTS Patients ( n = 189 ) with chronic cardiorespiratory diagnoses were recruited from respiratory , cardiovascular , and general medical wards at two tertiary hospitals . INTERVENTION Subjects were r and omly assigned to one of two groups . Intervention group patients received a discharge care plan in accordance with that outlined in the Australian Enhanced Primary Care Package , completed before discharge and sent to the patient 's general practitioner and other community service providers for review . Control patients were discharged under existing hospital processes . Outcome measures . Patients and general practitioners were surveyed pre-discharge and 7 days post-discharge for quality of life and opinion of discharge procedures . Hospital length of stay was also determined . RESULTS Significant improvements in discharge planning involvement , health service access , confidence with discharge procedures , and opinion of discharge based on previous experience were seen for patients who received the discharge care plan . Further , improved perceptions of mental quality of life were observed within the first week post-discharge for intervention patients . Length of stay showed no difference between groups . Extent and speed of hospital-general practitioner communication were significantly improved via the intervention . CONCLUSIONS Our results indicate that a multidisciplinary discharge care plan , initiated before separation , improves quality of life , involvement , and satisfaction with discharge care , and hospital-general practitioner integration . As such , it possesses benefits over current Western Australian hospital discharge procedures for the care of chronically ill population Background . The growing number of patients with congestive heart failure has increased both the pressure on hospital re sources and the need for community management of the condition . Improving hospital-to-home transition for this population is a logical step in responding to current practice guidelines ’ recommendations for coordination and education . Positive outcomes have been reported from trials evaluating multiple interventions , enhanced hospital discharge , and follow-up through the addition of a case management role . The question remains if similar gains could be achieved working with usual hospital and community nurses . Methods . A 12-week , prospect i ve , r and omized controlled trial was conducted of the effect of transitional care on health-related quality of life ( disease-specific and generic measures ) , rates of readmission , and emergency room use . The nurse-led intervention focused on the transition from hospital-to-home and supportive care for self-management 2 weeks after
Output:
| Compared with usual care , there was moderate quality evidence that individualized discharge planning is more effective at reducing readmissions or hospital LOS but not mortality , and very low quality evidence that it is more effective at improving HRQOL or patient satisfaction .
Compared with usual care , there was low quality evidence that the discharge planning plus postdischarge support is more effective at reducing readmissions but not more effective at reducing hospital LOS or mortality .
There was very low quality evidence that it is more effective at improving HRQOL or patient satisfaction |
MS210946 | ***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 Although the acute effect of intermittent pneumatic compression ( IPC ) therapy had been documented for patients with symptomatic peripheral arterial obstructive disease ( PAOD ) , its efficacy in improving quality of life ( QOL ) , especially for those with infrapopliteal diffuse lesions , remains unclear . METHODS AND RESULTS Thirty-one patients with infrapopliteal diffuse or multiple segmental lesions were enrolled in the study . Based on receipt of IPC therapy ( 3 h daily for 3 months ) , patients were allocated to a study ( n=23 ) or control ( n=8 ) group . The 6-min walking test , transcutaneous oxygen tension ( TcPO₂ ) , and QOL evaluated with the Short-Form 36 question naire were measured at the beginning and end of the study . In the QOL analysis , scores for physical functioning , physical and emotional role functioning , bodily pain , and general and mental health showed significant changes after IPC therapy . In the 6-min walking test , duration , and the initial and absolute claudication distances were significantly increased in the study group . The TcPO₂ also significantly increased in the distal end of the target limb after IPC therapy . CONCLUSIONS Patients at high risk for amputation with infrapopliteal diffuse or multiple segmental lesions can improve their walking ability , TcPO₂ of the target limb and QOL after IPC therapy BACKGROUND Traditional teaching assumes that the distal arterial tree is maximally dilated in patients with critical limb ischemia ( CLI ) . Endovascular or arterial bypass procedures are the commonly used interventions to increase distal perfusion . However , other forms of treatment such as spinal cord stimulation or intermittent pneumatic compression ( IPC ) have been shown to improve limb salvage rates . This prospect i ve study was design ed to determine if the use of IPC increases popliteal , gastrocnemial , collateral arterial , and skin blood flow in patients with CLI . METHODS Twenty limbs with CLI in 20 patients ( mean age , 74 years ) were evaluated with duplex ultrasound scans and laser Doppler fluxmetry in the semi-erect position before , during , and after IPC . One pneumatic cuff was applied on the foot and the other on the calf . The maximum inflation pressure was 120 mm Hg and was applied for 3 seconds at three cycles per minute . All patients had at least two-level disease by arteriography . Fourteen limbs were characterized as inoperable , and six were considered marginal for reconstruction . Flow volumes were measured in the popliteal , medial gastrocnemial , and a genicular collateral artery . Skin blood flux was measured on the dorsum of the foot at the same time . RESULTS Significant flow increase during the application of IPC was found in all three arteries ( 18/20 limbs ) compared with baseline values ( P < .02 ) . The highest change was seen in the popliteal , followed by the gastrocnemial and the collateral artery . After the cessation of IPC , the flow returned to baseline . This was attributed to the elevation of time average velocity , as the diameter of the arteries remained unchanged . The skin blood flux increased significantly as well ( P < .03 ) . In the two limbs without an increase in the arterial or skin blood flow , significant popliteal vein reflux was found . Both limbs were amputated shortly after . CONCLUSIONS IPC increases axial , muscular , collateral , and skin blood flow in patients with CLI and may be beneficial to those who are not c and i date s for revascularization . Patients with significant venous reflux may not benefit from IPC . This supports the theory that one of the mechanisms by which IPC enhances flow is by increasing the arteriovenous pressure gradient The SF-36 Health Survey is the most widely used self-report measure of functional health . It is commonly used in both r and omized controlled trials ( RCT ) and non-controlled evaluation of medical or other health services . However , determining a clinical ly significant change in SF-36 outcomes from pre-to-post-intervention , in contrast to statistically significant differences , is often not a focus of medical outcomes research . We propose use of the Reliable Change Index ( RCI ) in combination with SF-36 norms as one method for research ers , provider groups , and health care policy makers to determine clinical ly significant healthcare outcomes when the SF-36 is used as a primary measure . The RCI is a statistic that determines the magnitude of change score necessary of a given self-report measure to be considered statistically reliable . The RCI has been used to determine clinical ly significant change in mental health and behavioral medicine outcomes research , but is not widely applied to medical outcomes research . A usable table of RCIs for the SF-36 has been calculated and is presented . Instruction and a case illustration of how to use the RCI table is also provided . Finally , limitations and caution ary guidelines on using SF-36 norms and the RCI to determine clinical ly significant outcome are discussed BACKGROUND Patients with chronic critical limb ischemia following a failed bypass graft or with non-reconstructable distal disease diagnosed angiographically , have a very poor prognosis . This is a prospect i ve pilot study to assess the influence of the ArtAssist Device on pedal blood flow and amputation rate . METHODS Thirty-three legs in 25 patients were evaluated . Ten legs presented with rest pain , and 23 legs with tissue loss . Nine legs had previously undergone bypass surgery . RESULTS At a mean follow-up of 3 months , 14 ( 42 % ) legs were amputated , and 19 ( 58 % ) were saved . Eleven of the amputated legs were in patients with chronic renal failure , a known risk factor . The amputation rate , excluding this group , was 13.6 % ( 3/22 ) . Toe pressures measured initially and after 3 months on the pump showed a significant improvement ( p=0.03 ) . Forty percent of patients presenting with rest pain improved , while 26 % of foot ulcers healed on the pump . Mortality rate was 12 % . CONCLUSIONS The results from this prospect i ve study are encouraging but need to be vali date d in a larger prospect i ve r and omized study
Output:
| No difference in all-cause mortality was found .
Complications included pain associated with compression , as well as skin abrasion and contact rash as a result of the cuff rubbing against the skin .
In conclusion , the limited available results suggest that IPC may be associated with improved limb salvage , wound healing and pain management . |
MS210947 | ***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: OBJECTIVES To investigate the renoprotective effect of nicardipine in patients undergoing robot-assisted laparoscopic radical prostatectomy ( RALRP ) in a prospect i ve trial . Superior visualization of the increasingly performed RALRP requires pneumoperitoneum and extreme head-down tilt , both of which are associated with a decrease in postoperative renal function . Nicardipine causes preferential dilation of the renal arterioles and attenuates renal dysfunction after cardiac surgery . METHODS After we obtained institutional review board approval , we r and omly treated 100 patients undergoing RALRP with a continuous infusion of nicardipine at a rate of 0.5 microg/kg/min ( nicardipine group , n = 50 ) or with normal saline ( control group , n = 50 ) during surgery . We measured the serum creatinine ( Cr ) level and estimated glomerular filtration rate ( eGFR ) 1 day before surgery and the first and third postoperative days ( POD 1 and 3 , respectively ) . RESULTS Patients ' characteristics and operative data were similar between groups . The serum Cr was significantly higher and the eGFR was significantly lower in the control group at POD 1 . The number of patients having renal insufficiency ( eGFR < 60 mL/min/1.73 m(2 ) ) and abnormal serum creatinine level ( > 1.4 mg/dL ) was significantly greater in the control group ( 9 vs 1 , and 4 vs none , respectively ) at POD 1 . CONCLUSIONS Continuous infusion of low-dose nicardipine during RALRP seems to offset the deleterious effects of inevitable pneumoperitoneum and extreme head-down tilt on renal function in preserving the eGFR and attenuating the development of renal insufficiency in the immediate postoperative period OBJECTIVES Cardiopulmonary bypass ( CPB ) is widely regarded as an important contributor to renal failure , a well recognized complication following coronary artery surgery ( coronary artery bypass grafting ( CABG ) ) . Anecdotally off-pump coronary surgery ( OPCAB ) is considered renoprotective . We examine the extent of renal glomerular and tubular injury in low-risk patients undergoing either OPCAB or on-pump coronary artery bypass ( ONCAB ) . METHODS Forty low-risk patients with normal preoperative cardiac and renal functions awaiting elective CABG were prospect ively r and omized into those undergoing OPCAB ( n=20 ) and ONCAB ( n=20 ) . Glomerular and tubular injury were measured respectively by urinary excretion of microalbumin and retinol binding protein ( RBP ) indexed to creatinine ( Cr ) . Daily measurements were taken from admission to postoperative day 5 . Fluid balance , serum Cr and blood urea were also monitored . RESULTS No mortality or renal complication were observed . Both groups had similar demographic makeup , Parsonnet score , functional status and extent of coronary revascularization ( 2.1+/-1.0 vs. 2.5+/-0.7 grafts ; P=0.08 ) . Serum Cr and blood urea remained normal in both groups throughout the study . A significant and similar rise in urinary RBP : Cr occurred in both groups peaking on day 1 ( 3183+/-2534 vs. 4035+/-4079 ; P=0.43 ) before reapproximating baseline levels . These trends were also observed with urinary microalbumin : Cr ( 5.05+/-2.66 vs. 6.77+/-5.76 ; P=0.22 ) . Group B patients had a significantly more negative fluid balance on postoperative day 2 ( -183+/-1118 vs. 637+/-847 ml ; P=0.03 ) . CONCLUSIONS Although renal complication or serum markers of kidney dysfunction were absent , sensitive indicators revealed significant and similar injury to renal tubules and glomeruli following either OPCAB or ONCAB . These results suggest that avoidance of CPB does not offer additional renoprotection to patients at low risk of perioperative renal insult during CABG Deterioration of renal function , which can lead to postoperative renal failure , is a complication of surgery involving the suprarenal aorta and surgery involving the renal arteries . Fifty-four patients who were at risk for developing this complication were enrolled in a double-blind , r and omized , placebo-controlled trial of insulin-like growth factor ( IGF-I ) as a therapeutic agent to prevent the decline in renal function . The primary end point was the incidence of renal dysfunction , defined as a reduction of the glomerular filtration rate ( creatinine clearance ) at each of three measurements over 72 h. IGF-I ( 100 microg/kg subcutaneously every 12 h for 6 doses ) or placebo was administered on admission to the intensive care unit immediately postoperatively . IGF-I- and placebo-treated groups were well matched for sex , age , type of surgery , renal ischemic time during surgery ( ischemic index ) , baseline creatinine clearance , and baseline serum creatinine . No patient in the study developed acute renal failure postoperatively . IGF-I was well tolerated . A smaller proportion of patients in the IGF-I group had a postoperative decline in renal function ( 22 % ) than in the placebo-treated group ( 33 % ) . There were no significant differences in levels of serum creatinine at time of discharge , length of hospital stay , length of intensive care unit stay , length of intubation , or incidence of dialysis or death . Our findings establish the feasibility and potential utility for the use of IGF-I to reduce the incidence of postoperative renal dysfunction in high-risk patients OBJECTIVES We aim ed to evaluate the renoprotective role of renal-dose dopamine on cardiac surgical patients at high risk of postoperative renal dysfunction . The latter included older patients or those with pre-existing renal disease , elevated preoperative serum creatinine ( Cr ) , poor ventricular function , hypertension , diabetes mellitus and unstable angina requiring intravenous therapy . METHODS Fifty patients undergoing cardiopulmonary bypass ( CPB ) who fulfilled the entry criteria were prospect ively r and omized into two groups : Group 1 received a ' renal-dose ' ( 3 microg kg(-1 ) min(-1 ) ) dopamine infusion starting at anaesthetic induction for 48 h whilst saline infusion acted as placebo in Group 2 . The anaesthetic and CPB regimes were st and ardized . Urinary excretion of retinol binding protein ( RBP ) indexed to Cr , an accurate and sensitive marker of early renal tubular damage , was assessed daily for 6 days . Additional outcome measures included daily fluid balance , blood urea and serum Cr . Statistical comparisons were made using ANOVA and Mann-Whitney U-test . RESULTS No significant difference was found between the groups in their age , gender , preoperative NYHA class , ejection fraction , baseline serum Cr and duration of CPB and aortic cross-clamping . Renal replacement therapy was not required in any instance . Both groups demonstrated a similar and significant rise in urinary RBP throughout the study period . Dopamine-treated patients achieved more negative average fluid balance than those on placebo ( 5 vs. 229 ml , P<0.05 ) . CONCLUSIONS Renal-dose dopamine therapy failed to offer additional renoprotection to patients considered at increased risk of renal dysfunction after CPB BACKGROUND Low-dose dopamine is commonly administered to critically ill patients in the belief that it reduces the risk of renal failure by increasing renal blood flow . However , these effects have not been established in a large r and omised controlled trial , and use of dopamine remains controversial . We have done a multicentre , r and omised , double-blind , placebo-controlled study of low-dose dopamine in patients with at least two criteria for the systemic inflammatory response syndrome and clinical evidence of early renal dysfunction ( oliguria or increase in serum creatinine concentration ) . METHODS 328 patients admitted to 23 participating intensive-care units ( ICUs ) were r and omly assigned a continuous intravenous infusion of low-dose dopamine ( 2 microg kg(-1 ) min(-1 ) ) or placebo administered through a central venous catheter while in the ICU . The primary endpoint was the peak serum creatinine concentration during the infusion . Analyses excluded four patients with major protocol violations . FINDINGS The groups assigned dopamine ( n=161 ) and placebo ( n=163 ) were similar in terms of baseline characteristics , renal function , and duration of trial infusion . There was no difference between the dopamine and placebo groups in peak serum creatinine concentration during treatment ( 245 [ SD 144 ] vs 249 [ 147 ] micromol/L ; p=0.93 ) , in the increase from baseline to highest value during treatment ( 62 [ 107 ] vs 66 [ 108 ] micromol/L ; p=0.82 ) , or in the numbers of patients whose serum creatinine concentration exceeded 300 micromol/L ( 56 vs 56 ; p=0.92 ) or who required renal replacement therapy ( 35 vs 40 ; p=0.55 ) . Duration s of ICU stay ( 13 [ 14 ] vs 14 [ 15 ] days ; p=0.67 ) and of hospital stay ( 29 [ 27 ] vs 33 [ 39 ] days ; p=0.29 ) were also similar . There were 69 deaths in the dopamine group and 66 in the placebo group . INTERPRETATION Administration of low-dose dopamine by continuous intravenous infusion to critically ill patients at risk of renal failure does not confer clinical ly significant protection from renal dysfunction Activation of the renin-angiotensin system during open heart surgery may have consequences both beneficial in sustaining blood pressure and deleterious in compromising renal hemodynamics . The influence of short-term pretreatment with captopril on blood pressure and renal function was assessed double-blind versus placebo in 18 patients without pre-existing cardiac or renal failure , and undergoing coronary artery bypass . No difference in blood pressure and fluid requirement during the surgical period was observed between groups receiving captopril or placebo . Effective renal plasma flow and glomerular filtration rate decreased in the placebo group whereas they remained unaltered in the captopril group ; during cardiopulmonary bypass , urinary excretion of sodium was greater in patients receiving captopril than those receiving placebo . These results suggest that captopril pretreatment does not compromise the control of blood pressure and renal function during open heart surgery ; additional studies on the protective value of angiotensin-converting enzyme inhibitors are warranted in patients at higher risk for developing renal failure BACKGROUND AND OBJECTIVE Postoperative renal impairment is a recognized complication of infrarenal aortic cross-clamping . Our hypothesis was that the renal vasodilating and natriuretic effects of fenoldopam mesylate , a selective dopamine ( DA1 ) agonist , would preserve renal function in patients undergoing elective infrarenal aortic cross-clamping . METHODS A prospect i ve , r and omized , double blind controlled clinical trial was performed . Twenty-eight ASA II-III patients undergoing elective aortic surgery requiring infrarenal aortic cross-clamping were studied . According to r and om allocation , patients received either fenoldopam ( 0.1 microg kg(-1 ) min(-1 ) ) or placebo intravenously prior to surgical skin incision until release of the aortic clamp . Plasma creatinine , creatinine clearance , urinary output , fractional excretion of sodium , and free water clearance were measured : ( a ) prior to admission to hospital ; ( b ) during the period from insertion of the urinary catheter until application of the aortic cross-clamp ; ( c ) during the period of aortic cross-clamping ; ( d ) 0 - 4 h , and ( e ) 4 - 8 h after release of the clamp and on days 1 , 2 , 3 , and 5 postoperatively . RESULTS Fenoldopam ( 0.1 microg kg(-1)min(-1 ) ) administration was not associated with haemodynamic instability . On application of the aortic cross-clamp creatinine clearance decreased significantly in the placebo ( 83 + /- 20 to 42 + /- 29 mL min(-1 ) ( mean + /- SD ) ) ( P < 0.01 ) but not in the fenoldopam group , and this decrease persisted for at least 8 h after release of the cross-clamp ( 83 + /- 20 to 54 + /- 33 mL min(-1 ) ( mean + /- SD ) ) ( P < 0.05 ) . Plasma creatinine concentration increased significantly from baseline on the first postoperative day in the placebo group ( 87 + /- 12 to 103 + /- 28 micromolL(-1 ) ( mean + /- SD ) ) ( P < 0.01 ) but not in the fenoldopam group . CONCLUSIONS These findings are consistent with the hypothesis that fenoldopam possesses a renoprotective effect during and after infrarenal aortic cross-clamping In a prospect i ve r and omized trial of 16 patients undergoing abdominal vascular reconstructive procedures , changes in plasma volume , serum on
Output:
| Because of considerable clinical heterogeneity ( different clinical scenarios , as well as considerable method ological variability amongst the studies ) , we did not perform a meta- analysis on the combined data .Subgroup analysis of major interventions and surgical procedures showed no significant influence of interventions on reported mortality and acute renal injury .
No reliable evidence from the available literature suggests that interventions during surgery can protect the kidneys from damage . |
MS210948 | ***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 comparative effectiveness of treatments for prostate cancer that is detected by prostate-specific antigen ( PSA ) testing remains uncertain . METHODS We compared active monitoring , radical prostatectomy , and external-beam radiotherapy for the treatment of clinical ly localized prostate cancer . Between 1999 and 2009 , a total of 82,429 men 50 to 69 years of age received a PSA test ; 2664 received a diagnosis of localized prostate cancer , and 1643 agreed to undergo r and omization to active monitoring ( 545 men ) , surgery ( 553 ) , or radiotherapy ( 545 ) . The primary outcome was prostate-cancer mortality at a median of 10 years of follow-up . Secondary outcomes included the rates of disease progression , metastases , and all-cause deaths . RESULTS There were 17 prostate-cancer-specific deaths overall : 8 in the active-monitoring group ( 1.5 deaths per 1000 person-years ; 95 % confidence interval [ CI ] , 0.7 to 3.0 ) , 5 in the surgery group ( 0.9 per 1000 person-years ; 95 % CI , 0.4 to 2.2 ) , and 4 in the radiotherapy group ( 0.7 per 1000 person-years ; 95 % CI , 0.3 to 2.0 ) ; the difference among the groups was not significant ( P=0.48 for the overall comparison ) . In addition , no significant difference was seen among the groups in the number of deaths from any cause ( 169 deaths overall ; P=0.87 for the comparison among the three groups ) . Metastases developed in more men in the active-monitoring group ( 33 men ; 6.3 events per 1000 person-years ; 95 % CI , 4.5 to 8.8 ) than in the surgery group ( 13 men ; 2.4 per 1000 person-years ; 95 % CI , 1.4 to 4.2 ) or the radiotherapy group ( 16 men ; 3.0 per 1000 person-years ; 95 % CI , 1.9 to 4.9 ) ( P=0.004 for the overall comparison ) . Higher rates of disease progression were seen in the active-monitoring group ( 112 men ; 22.9 events per 1000 person-years ; 95 % CI , 19.0 to 27.5 ) than in the surgery group ( 46 men ; 8.9 events per 1000 person-years ; 95 % CI , 6.7 to 11.9 ) or the radiotherapy group ( 46 men ; 9.0 events per 1000 person-years ; 95 % CI , 6.7 to 12.0 ) ( P<0.001 for the overall comparison ) . CONCLUSIONS At a median of 10 years , prostate-cancer-specific mortality was low irrespective of the treatment assigned , with no significant difference among treatments . Surgery and radiotherapy were associated with lower incidences of disease progression and metastases than was active monitoring . ( Funded by the National Institute for Health Research ; ProtecT Current Controlled Trials number , IS RCT N20141297 ; Clinical Trials.gov number , NCT02044172 . ) Purpose : We evaluated focal therapy with high intensity focused ultrasound hemiablation in a prospect i ve trial . Material s and Methods : We performed a prospect i ve , multicenter , single arm study in patients with unilateral low/intermediate risk prostate cancer who were treated from April 2013 through March 2016 in Germany in AUO ( Arbeitsgemeinschaft Urologische Onkologie ) Study Protocol AP 68/11 . Unilateral prostate cancer was assessed by transrectal ultrasound guided biopsy and multiparametric magnetic resonance imaging . Hemiablation was done using the Ablatherm ® or the Focal One ® device . The oncologic outcome was assessed by the salvage treatment rate , multiparametric magnetic resonance imaging and rebiopsy at 12 months . Functional outcome , quality of life , anxiety and depression were measured by vali date d question naires at baseline and every 3 months . Results : Of the 54 recruited patients 51 completed 12‐month or greater visits . Mean ± SD followup was 17.4 ± 4.5 months . Mean prostate specific antigen decreased from 6.2 ± 2.0 to 2.9 ± 1.9 ng/ml at 12 months ( p < 0.001 ) . Biopsy at 12 months was positive for any prostate cancer and for clinical ly significant prostate cancer in 13 ( 26.5 % ) and 4 ( 8.2 % ) of the 49 patients , respectively . Posttreatment multiparametric magnetic resonance imaging had limited 25 % sensitivity for clinical ly significant prostate cancer . Ten patients ( 19.6 % ) underwent salvage treatment . Potency was maintained in 21 of the 30 men who were potent preoperatively . There was no increase in incontinence . Quality of life , anxiety and depression did not change postoperatively . The study was limited by a short followup and the lack of a control arm . Conclusions : Focal therapy hemiablation is safe with little alteration of functional outcome . The oncologic outcome is acceptable on short‐term followup . Followup multiparametric magnetic resonance imaging performed poorly and should not replace repeat biopsy . Focal therapy has no impact on posttreatment anxiety and depression PURPOSE Cryosurgical ablation of the prostate is a novel therapeutic modality that induces cell lysis in the prostate by direct application of low temperatures . We have been conducting an ongoing prospect i ve pilot study of the use of cryosurgical prostate ablation in treating patients with nonmetastatic prostate adenocarcinoma since January 1993 . Results in 145 consecutive patients with mean 36 months and minimum 12 months of followup are presented . MATERIAL S AND METHODS Accrual was open to patients with clinical stages T1a to T3c prostate adenocarcinoma . Pelvic lymph node dissections were recommended but not required for patients with prostate specific antigen ( PSA ) greater than 15 ng./ml . before study entry . PSA changes , r and om prostate biopsy findings and morbidities after cryosurgical prostate ablation were recorded for each patient . RESULTS Overall actuarial rates at 42 months for maintaining PSA less than 0.3 and less than 1.0 were 59 % and 66 % , respectively . The overall actuarial progression-free rate at 60 months was 56 % . Among 160 biopsies performed 16 % showed some evidence of residual carcinoma . Overall crude rates of maintaining either a negative biopsy or PSA less than 0.3 at 6 and 24 months after cryosurgical prostate ablation were 87 % and 73 % , respectively . Significantly higher morbidities were seen in previously radiated patients undergoing cryosurgical prostate ablation compared to those with no prior radiation . Among nonradiated patients 85 % experienced no significant morbidity after cryosurgical prostate ablation . CONCLUSIONS Although preliminary , short-term outcomes after cryosurgical prostate ablation appear to be comparable to identical outcomes reported for external beam radiotherapy . Based on these results cryosurgical prostate ablation appears to be an effective therapeutic alternative for treating patients with localized prostate adenocarcinoma Introduction Focal therapy offers the possibility of cancer control , without the side effect profile of radical therapies . Early single centre prospect i ve development studies using high intensity focused ultrasound ( HIFU ) have demonstrated encouraging genitourinary functional preservation and short-term cancer control . Large multi-centre trials are required to evaluate medium-term cancer control and reproduce functional recovery . We describe the study design of an investigator-led UK multi-centre , single arm trial using HIFU to deliver focal therapy for men with localised prostate cancer . Methods One-hundred and forty men with histologically proven localised low or intermediate risk prostate cancer ( PSA < 15 , Gleason ≤ 7 , ≤ T2cN0M0 ) will undergo precise characterisation of the prostate using a combination of multi-parametric (mp)MRI and transperineal template prostate mapping ( TPM ) biopsies . Unilateral dominant tumours , the so-called index lesion , will be eligible for treatment provided the contra-lateral side is free of ‘ clinical ly significant ’ disease ( as defined by Gleason ≥ 7 or maximum cancer core length ≥ 4 mm ) . Patients will receive focal therapy using HIFU ( Sonablate 500 ® ) . Treatment effect will be assessed by targeted biopsies of the treated area and TPM biopsies at 36-months . Results Primary outcome is the absence of clinical ly significant disease based on 36-month post-treatment TPM biopsies . Secondary outcomes address a ) genitourinary function using vali date d patient question naires ( IPSS , IPSS-QoL , IIEF-15 , EPIC-Urinary , EPIC-Bowel , FACT-P , EQ-5D ) , b ) the predictive validity of imaging , and c ) risk factors for treatment failure . Conclusions INDEX will be the first multi-centre , medium term follow-up trial to evaluate the outcomes of a tissue preserving strategy for men with localised prostate cancer using the TPM-ablate-TPM strategy Surgery and other invasive therapies are complex interventions , the assessment of which is challenged by factors that depend on operator , team , and setting , such as learning curves , quality variations , and perception of equipoise . We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process . We also encourage the widespread use of prospect i ve data bases and registries . Reports of new techniques should be registered as a professional duty , anonymously if necessary when outcomes are adverse . Case series studies should be replaced by prospect i ve development studies for early technical modifications and by prospect i ve research data bases for later pre-trial evaluation . Protocol s for these studies should be registered publicly . Statistical process control techniques can be useful in both early and late assessment . R and omised trials should be used whenever possible to investigate efficacy , but adequate pre-trial data are essential to allow power calculations , clarify the definition and indications of the intervention , and develop quality measures . Difficulties in doing r and omised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems . Alternative prospect i ve design s , such as interrupted time series studies , should be used when r and omised trials are not feasible . Established procedures should be monitored with prospect i ve data bases to analyse outcome variations and to identify late and rare events . Achievement of improved design , conduct , and reporting of surgical research will need concerted action by editors , funders of health care and research , regulatory bodies , and professional societies OBJECTIVE To determine the minimal important difference ( MID ) in generic and prostate-specific health-related quality of life ( HRQoL ) using distribution- and anchor-based methods . STUDY DESIGN AND SETTING Prospect i ve cohort study of 602 newly diagnosed prostate cancer patients recruited from an urban academic hospital and a Veterans Administration hospital . Participants completed generic ( SF-36 ) and prostate-specific HRQoL surveys at baseline and at 3 , 6 , 12 , and 24 months posttreatment . Anchor-based and distribution-based methods were used to develop MID estimates . We compared the proportion of participants returning to baseline based on MID estimates from the two methods . RESULTS MID estimates derived from combining distribution- and anchor-based methods for the SF-36 subscales are physical function = 7 , role physical = 14 , role emotional = 12 , vitality = 9 , mental health = 6 , social function = 9 , bodily pain = 9 , and general health = 8 ; and for the prostate-specific scales are urinary function = 8 , bowel function = 7 , sexual function = 8 , urinary bother = 9 , bowel bother = 8 , and sexual bother = 11 . Proportions of participants returning to baseline values corresponding to MID estimates from the two methods were comparable . CONCLUSIONS This is the first study to assess the MID for generic and prostate-specific HRQoL using anchor-based and distribution-based methods . Although variation exists in the MID estimates derived from these two methods , the recovery patterns corresponding to these estimates were comparable A recent r and omized trial to compare external beam radiation therapy ( EBRT ) to cryoablation for localized disease showed cryoablation to be noninferior to external beam EBRT in disease progression and overall and disease‐specific survival . We report on the quality of life ( QOL ) outcomes for this trial PURPOSE Patients currently diagnosed with low risk prostate cancer are often overtreated and experience complications , result ing in detriment to quality of life . Targeted focal therapy is a minimally invasive procedure design ed to ablate tumor foci while minimizing collateral damage to maintain quality of life . MATERIAL S AND METHODS This institutional review board approved , prospect i ve study was done to assess the safety and efficacy of targeted focal therapy using cryotherapy in men 40 to 85 years old diagnosed with low risk , organ confined prostate cancer at our institution between 2006 and 2009 . Low risk , organ confined prostate cancer was defined as Gleason score 7 or less ( 3 + 4 ) on transrectal ultrasound biopsy , tumor burden 50 % or less and prostate specific antigen less than 10 ng/dl . Patients were evaluated for eligibility after undergoing 3-dimensional mapping biopsy . Median
Output:
| Based on very low quality evidence , primary whole gl and cryotherapy has uncertain effects on oncologic outcomes , QoL , and major adverse events compared to external beam radiotherapy . |
MS210949 | ***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 Recent findings suggest that executive function ( EF ) plays a critical role in the regulation of gait in older adults , especially under complex and challenging conditions , and that EF deficits may , therefore , contribute to fall risk . The objective of this study was to evaluate if reduced EF is a risk factor for future falls over the course of 5 years of follow-up . Secondary objectives were to assess whether single and dual task walking abilities , an alternative window into EF , were associated with fall risk . Methodology /Main Results We longitudinally followed 256 community-living older adults ( age : 76.4±4.5 yrs ; 61 % women ) who were dementia free and had good mobility upon entrance into the study . At baseline , a computerized cognitive battery generated an index of EF , attention , a closely related construct , and other cognitive domains . Gait was assessed during single and dual task conditions . Falls data were collected prospect ively using monthly calendars . Negative binomial regression quantified risk ratios ( RR ) . After adjusting for age , gender and the number of falls in the year prior to the study , only the EF index ( RR : .85 ; CI : .74–.98 , p = .021 ) , the attention index ( RR : .84 ; CI : .75–.94 , p = .002 ) and dual tasking gait variability ( RR : 1.11 ; CI : 1.01–1.23 ; p = .027 ) were associated with future fall risk . Other cognitive function measures were not related to falls . Survival analyses indicated that subjects with the lowest EF scores were more likely to fall sooner and more likely to experience multiple falls during the 66 months of follow-up ( p<0.02 ) . Conclusions / Significance These findings demonstrate that among community-living older adults , the risk of future falls was predicted by performance on EF and attention tests conducted 5 years earlier . The present results link falls among older adults to cognition , indicating that screening EF will likely enhance fall risk assessment , and that treatment of EF may reduce fall risk BACKGROUND Executive function ( EF ) deficits may increase fall risk , even among older adults with no overt cognitive impairment . Indeed , the effects of dual tasking ( DT ) on gait , a challenge to executive control , are more exaggerated in persons with a history of falls . Prospect i ve evidence is , however , lacking . METHODS We prospect ively evaluated whether EF predicts falls over a 2-year period among 262 community-living , healthy , and well-functioning older adults , focusing on the 201 who reported no falls during the previous year . At baseline , participants completed a computerized cognitive battery that generated an index of EF and other cognitive domains . Gait was assessed using performance-based tests and by quantifying walking during single- and dual-task conditions . RESULTS The 262 participants ( mean age : 76.3 ± 4.3 years , 60.3 % women ) had intact cognitive function on testing , a low comorbidity index , and good mobility . The EF index predicted future falls . Among those who reported no previous falls , participants in the worst EF quartile were three times more likely to fall during the 2 years of follow-up , and they were more likely to transition from nonfaller to faller sooner . DT gait variability also predicted future falls and multiple falls , whereas other measures of cognitive function , gait , and mobility did not . CONCLUSIONS Among healthy older adults , individuals with poorer EF are more prone to falls . Higher-level cognitive functions such as those regulated by the frontal lobes are apparently needed for safe everyday navigation that dem and s multitasking . Optimal screening , early detection , and treatment of falls should , apparently , also target this cognitive domain Background Older adults with concerns of falling show decrements of gait stability under single ( ST ) and dual task ( DT ) conditions . To compare the effects of a DT training integrating task managing strategies for independent living older adults with and without concern about falling ( CoF ) to a non-training control group on walking performance under ST and DT conditions . Methods Single center parallel group single blind r and omized controlled trial with group-based interventions ( DT-managing balance training ) compared to a control group ( Ninety-five independent living older adults ; 71.5 ± 5.2 years).A progressive DT training ( 12 sessions ; 60 min each ; 12 weeks ) including task-managing strategies was compared to a non-training control group . Setting : group based intervention for independent living elderly in a gym . ST and DT walking ( visual verbal Stroop task ) were measured on a treadmill . Gait parameters ( step length , step width , and gait line ) and cognitive performance while walking were compared with a 2x2x2 Repeated Measures Analyses of Variance . Results Participants in the intervention group showed an increased step length under ST and DT conditions following the intervention , for both people with and without CoF compared to their respective control groups . Foot rolling movement and cognitive performance while walking however only improved in participants without CoF. Conclusions The results showed that DT managing training can improve walking performance under ST and DT conditions in people with and without CoF. Additional treatment to directly address CoF , such as cognitive behavioural therapy , should be considered to further improve the cautious gait pattern ( as evidence d by reduced foot rolling movements).Trial registration The study was retrospectively registered in the German Clinical Trials Register ( DRKS ; Identification number DRKS00012382 , 11.05.2017 ) Objective : To determine whether brain activity over the prefrontal cortex measured in real time during walking predicts falls in high-functioning older adults . Method : We examined166 older persons ( mean age 75 years , 51 % women ) enrolled in a prospect i ve aging study . High-functioning status defined as the absence of dementia or disability with normal gait diagnosed by study clinicians . The magnitude of task-related changes in oxygenated hemoglobin levels over the prefrontal cortex was measured with functional near-infrared spectroscopy during motor ( walking at normal pace ) and cognitive ( reciting alternate letters of the alphabet ) single tasks and a dual-task condition ( walking while reciting alternate letters of the alphabet ) . Incident falls were prospect ively assessed over a 50-month study period . Results : Over a mean follow-up of 33.9 ± 11.9 months , 116 falls occurred . Higher levels of prefrontal cortical activation during the dual-task walking condition predicted falls ( hazard ratio adjusted for age , sex , education , medical illnesses and general mental status 1.32 , 95 % confidence interval 1.03–1.70 ) . Neither behavioral outcomes ( velocity or letter rate ) on the dual task nor brain activation patterns on the single tasks ( normal walk or talk alone ) predicted falls in this high-functioning sample . The results remained robust after accounting for multiple confounders and for cognitive status , slow gait , previous falls , and frailty . Conclusions : Prefrontal brain activity levels while performing a cognitively dem and ing walking condition predicted falls in high-functioning seniors . These findings implicate neurobiological processes early in the pathogenesis of falls OBJECTIVE As 90 % of fractures are caused by falls , and as fractures are more common in elderly women than in elderly men , a better underst and ing of potential sex differences in fall rates and underlying mechanisms is needed . The purpose of this study was to determine whether women are more prone than men to falling , and to evaluate whether the risk of falling is associated with variations in gait patterns . DESIGN , SETTING , AND PARTICIPANTS The cohort for this prospect i ve observational study consisted of 1390 community-dwelling men and women aged 70 years , examined in a health survey between July 2012 and November 2014 . MEASUREMENTS Gait patterns were measured using a computerized walkway system during normal-speed , fast-speed , and dual-task trials . Triaxial accelerometers were used to collect objective data on physical activity , and self-reported fall data were collected by telephone 6 and 12 months after examination . Incident low-energy falls were defined as unexpected events in which participants came to rest on the ground . RESULTS During the follow-up period , 148 study participants ( 88 women , 60 men ; P = .01 ) reported falls . After adjusting for multiple confounders , including objective measures of physical activity , socioeconomic factors , cardiovascular disease , and cognitive function , the odds ratio for falling in women was 1.49 ( 95 % confidence interval [ CI ] 1.02 - 2.19 ) . Variations in gait pattern were significantly ( 20%-40 % ) increased in fallers compared with nonfallers during the dual-task trial for step width , step length , stride length , step time , stance time , stride velocity , and single support time ( all P < .05 ) . Furthermore , women showed 15 % to 35 % increased variability in all of these gait parameters during the dual-task trial compared with men ( all P < .01 ) . CONCLUSION In the present cohort , 70-year-old women were at greater risk of falls compared with their male counterparts . This increased risk was associated with increased variation in gait pattern during dual-task activities , and may contribute to women 's greater fracture risk compared with men Objective : To evaluate the long-term effects of a progressive and specific balance group-based program in healthy elderly individuals with increased risk of falling . Design : Follow-up of a r and omized controlled trial at nine and 15 months on a population that has previously been described at three months . Setting : The study was conducted in Stockholm , Sweden . Subjects : 59 community-dwelling elderly ( age 67–93 years ) , recruited by advertisement , were r and omly allocated to training or to serve as controls . Intervention : Group balance training three times per week during 12 weeks with a 15 month follow-up time . Main measures : Participants were assessed at baseline , three , nine , and 15 months thereafter for gait function ( preferred and fast walking ) , rapid step execution ( single and dual task ) , fear of falling , and likelihood of depression . Results : Fast gait speed ( p = 0.004 ) , dual task step execution ( p = 0.006 ) and fear of falling ( p = 0.001 ) were still improved in the training group at nine months follow-up . Only self-perceived fear of falling remained significantly improved ( p = 0.012 ) at 15 months follow-up . Although fast gait speed had decreased to baseline level in the training group ( 1.49 m/s ) it remained significantly higher than in the control group ( 1.37 m/s ) at the end of the study , a difference between the groups that was not seen at baseline . Conclusion : This training program provided important positive short and long-term benefits to gait , balance function , and fear of falling OBJECTIVES To determine whether dual task-related changes in walking speed were associated with recurrent falls in frail older adults . DESIGN Twelve-month prospect i ve cohort study . SETTING Thirteen senior housing facilities . PARTICIPANTS Two hundred thirteen subjects ( mean age 84.4+/-5.5 ) . MEASUREMENTS Usual and dual-tasking walking speeds ( m/s ) were calculated on a 10-m straight walkway at baseline . Information on incident falls during the follow-up year was collected monthly , and participants were divided into three groups based on the occurrence of falls ( 0 , 1 , and > or=2 ) . Recurrent falls were defined as two or more falls during the 12-month follow-up period . RESULTS Twenty subjects ( 9.4 % ) were classified as recurrent fallers . The occurrence of recurrent falls was associated with age ( crude odds ratio (OR)=1.11 , P=.02 ) , number of drugs ( crude OR=1.28 , P=.002 ) , and walking speed under both walking conditions ( crude OR=0.96 , P=.002 for usual walking and crude OR=0.60 , P=.005 for walking while counting backward ) . Multiple Poisson regression showed that only walking speed while dual tasking and number of drugs were associated with incident falls ( incident rate ratio (IRR)=0.84 , P=.045 and IRR=1.10 , P=.004 ) . CONCLUSION Slower walking speed while counting backward was associated with recurrent falls , suggesting that changes in gait performance while dual tasking might be an inexpensive way of identifying frail older adults prone to falling Objective : To evaluate the effects of a new , individually adjusted , progressive and specific balance group training programme on fear of falling , step execution , and gait in healthy elderly people with fear of falling and tend to fall . Design : R and omized controlled trial . Setting : The study was conducted in Stockholm County , Sweden . Subjects : Fifty-nine community dwelling elderly people were recruited by advertisement , and allocated at r and om to an intervention group ( n = 38 ) or a control group ( n = 21 ) . Intervention : Individually adjusted , progressive and specific balance group training was given three times a week for three months . The training incorporated elements included in , and required for , independent activities of daily living , and for reactions to loss of balance during dual or multiple tasks . Main measures : Fear of falling was assessed with Falls Efficacy Scale International ( FES-I ) . The reaction time of step execution was measured with the step-execution test , and gait was measured with GAITRite ® . Results : After three months the intervention group showed significant positive changes in the FES-I ( P = 0.008 ) , in the step-execution phase of dual-task performance ( P = 0.012 ) , and in gait at preferred speed during single-task performance ; in cadence ( P = 0.030 ) and , at fast speed , in velocity ( P = 0.004 ) and cadence ( P = 0.001 ) . Significant decreases were also found for the likelihood of depression after participating in the training programme . Conclusion : This new balance training programme is feasible and leads to decreased fear of falling , decreased time for step execution during dual-task performance and increased velocity during fast walking OBJECT
Output:
| Conclusion CMI was not significantly different between fallers and non-fallers or people with and without CoF ; however , our taxonomy revealed a large variety of cognitive conditions and a higher number of studies using mental tracking tasks , which make it impossible to draw firm conclusions . |
MS210950 | ***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: AIM This study aim ed to compare the effect of single-visit full-mouth mechanical debridement ( FMD ) and quadrant-wise mechanical debridement ( QMD ) on the levels of serum interleukin (IL)-6 , C-reactive protein ( CRP ) and soluble thrombomodulin . MATERIAL AND METHODS Thirty-six subjects with chronic periodontitis were r and omly allocated to three groups : undergoing QMD , single-visit FMD with povidone iodine or with water . Serum IL-6 and soluble thrombomodulin were measured by enzyme-linked immunosorbent assay , and serum CRP was measured by the latex-enhanced nephelometric method . RESULTS Serum IL-6 level increased significantly immediately after debridement in all the three groups , with this increase being greatest in the full-mouth groups . However , the increase in the full-mouth groups was not significantly higher than that of quadrant-wise group . In the quadrant-wise group , serum IL-6 level decreased significantly 1 month after debridement compared with baseline . Serum-soluble thrombomodulin decreased significantly in the full-mouth groups but not in the quadrant-wise group . Changes in CRP level were not significant at baseline or after debridement in all the three groups . CONCLUSIONS FMD increased serum IL-6 and reduced serum-soluble thrombomodulin to a greater extent than QMD , suggesting that the former technique has stronger transient effects on systemic vascular endothelial functions than the latter Background Periodontal disease ( PD ) is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host . It has been proposed that PD as sub clinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis . A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infa rct ion , peripheral vascular disease , and cerebrovascular disease . Moreover , new r and omized controlled clinical trials have shown an improvement on cardiovascular surrogate markers ( endothelial function , sICAM , hsPCR level , fibrinogen ) after periodontal treatment . Nonetheless , such trials are still limited in terms of external validity , periodontal treatment strategies , CONSORT-based design and results consistency/extrapolation . The current study is design ed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis . Methods / Design This r and omized , single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies . After medical/periodontal screening , a baseline endothelium-dependent brachial artery flow-mediated dilatation ( FMD ) and other systemic surrogate markers will be obtained from all recruited subjects . Patients then will be r and omized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine ( treatment group ) or supragingival plaque removal only ( control group ) . A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms . Each group will consist of 49 patients ( n = 98 ) and all patients will be followed-up for secondary outcomes and will be monitored through a coordinating center . The primary outcomes are FMD differences baseline , 24 hours and 3 months after treatment . The secondary outcomes are differences in C-reactive protein ( hs-CRP ) , glucose serum levels , blood lipid profile , and HOMA index . Discussion This RCT is expected to provide more evidence on the effects of different periodontal treatment modalities on FMD values , as well as to correlate such findings with different surrogate markers of systemic inflammation with cardiovascular effects . Trial registration number Clinical Trials.gov Identifier : NCT00681564 Much work has been published on the association between periodontal disease and systemic disease , including original reports , narrative review s , systematic review s , and meta-analyses . Based on the existent work , one can assign an evidence level and grade , using st and ard evidence -based criteria , to the data available in the four major categories of medical outcomes studied : cardiovascular/cerebrovascular , pregnancy , pulmonary , and diabetes . We discuss method ologic and conceptual problems in the study of oral-systemic associations , focusing as an example on the association between periodontal disease and cardiovascular/cerebrovascular disease . We argue that the hierarchical ranking of studies by levels of evidence may be misleading . In particular , while r and omized controlled trials ( RCTs ) are needed to determine the efficacy of periodontal treatment to reduce the risk of cardiovascular events , they may be of limited value in determining the etiologic role of periodontal disease on coronary heart disease and stroke . We discuss limitations of RCTs as well as the limitations of currently available data from epidemiologic studies , including study design and confounding and misclassification errors . We conclude that well- design ed observational studies into the associations between periodontal disease and systemic disease need to remain an integral component of future research efforts in order to fully underst and such associations BACKGROUND Rheumatoid arthritis ( RA ) and periodontitis are common chronic inflammatory conditions . Recent studies showed a beneficial effect of periodontal treatment on the severity of active RA . This study was undertaken to further examine the effect of non-surgical periodontal treatment on the signs and symptoms of RA in patients treated with or without anti-tumor necrosis factor-alpha ( anti-TNF-alpha ) medications . The effect of anti-TNF-alpha therapy on periodontitis also was assessed . METHODS Forty participants diagnosed with moderate/severe RA ( under treatment for RA ) and severe periodontitis were r and omly assigned to receive initial non-surgical periodontal therapy with scaling/root planing and oral hygiene instructions ( n = 20 ) or no periodontal therapy ( n = 20 ) . To control RA , all participants had been using disease-modifying anti-rheumatic drugs , and 20 had also been using anti-TNF-alpha before r and omization . Probing depth ( PD ) , clinical attachment level ( CAL ) , bleeding on probing ( BOP ) , gingival index ( GI ) , plaque index ( PI ) , RA disease activity score 28 ( DAS28 ) , and erythrocyte sedimentation rate ( ESR ) were measured at baseline and 6 weeks later . Linear mixed models were used to identify significant differences between subjects who received periodontal treatment and those who did not . RESULTS Patients receiving periodontal treatment showed a significant decrease in the mean DAS28 , ESR ( P < 0.001 ) , and serum TNF-alpha ( P < 0.05 ) . There was no statistically significant decrease in these parameters in patients not receiving periodontal treatment . Anti-TNF-alpha therapy result ed in a significant improvement in CAL , PD , BOP , and GI . CONCLUSIONS Non-surgical periodontal therapy had a beneficial effect on the signs and symptoms of RA , regardless of the medications used to treat this condition . Anti-TNF-alpha therapy without periodontal treatment had no significant effect on the periodontal condition BACKGROUND Chronic infections , such as periodontitis , are associated with increased risk of systemic diseases driven by a persistent low- grade systemic inflammation and metabolic changes . Severity of periodontitis has also been associated with increased systolic blood pressure ( BP ) . However , the issue remains poorly investigated . We aim ed to estimate the effect of periodontal therapy on traditional and novel cardiovascular risk factors in systemically healthy individuals who have periodontitis . METHODS We enrolled 40 otherwise healthy patients with severe chronic generalized periodontitis in a 6-month pilot intervention trial . Individuals were r and omized either to a st and ard course of periodontal therapy ( subgingival scaling and root planing ) or an intensive one ( including the adjunctive use of a locally delivered antimicrobial , IPT ) . RESULTS Compared to control , IPT produced significant reductions in a cluster of inflammatory markers at 1 ( P = .0406 ) and 2 ( P = .0060 ) months together with an improvement in lipid markers at 2 ( P = .0320 ) and 6 ( P = .0432 ) months after therapy . Intensive periodontal therapy produced greater reductions in IL-6 at 1 ( 0.4 + /- 0.2 ng/L difference , 95 % CI 0.03 - 0.9 , P = .0284 ) and 2 months ( 0.3 + /- 0.2 ng/L difference , 95 % CI 0.1 - 0.8 , P = .0284 ) , together with decreases in C-reactive protein ( 0.4 + /- 0.2 mg/L difference , 95 % CI 0.01 - 0.8 , P = .0438 ) and total cholesterol ( 0.3 + /- 0.1 mmol/L difference , 95 % CI 0.04 - 0.6 , P = .0254 ) . Moreover , a 7 + /- 3-mm Hg decrease in systolic BP was observed at 2 months in the IPT group ( 95 % CI 1 - 12 , P = .0211 ) , and this difference was greater in current smokers ( 14 + /- 5 mm Hg 95 % CI 3 - 25 , P = 0.0124 ) . Intensive periodontal therapy subjects exhibited a 1.53 % + /- 1.20 % ( 95 % CI 1.05 - 2.24 , P = .0290 ) and 2.00 % + /- 1.42 % ( 95 % CI 0.98 - 4.09 , P = .0568 ) decreases in cardiovascular risk scores ( Framingham ) at 2 and 6 months , respectively , when compared to those in the st and ard group . CONCLUSIONS Our findings suggest that intensive periodontal treatment reduces systemic inflammatory markers and systolic BP , and improves lipid profiles with subsequent changes in cardiovascular risk when compared to st and ard therapy AIM We studied the effect of atorvastatin ( ATV ) treatment on bone loss prevention in subjects with chronic periodontitis . MATERIAL AND METHODS In this controlled double-blind study , 38 subjects with chronic periodontitis were r and omized into two groups , paired by age to receive ATV ( 20 mg ) or placebo daily for 3 months . Periodontal mechanical treatment was carried out in both groups at baseline . Clinical and radiographic parameters and bone turnover markers were assessed at baseline and at 3 months . RESULTS Periodontal disease conditions improved in both groups . After comparing the figures of change , significant improvements were observed in cholesterol levels ( Δ=-58.5 ± 37.6 versusΔ=5.4 ± 41.2 mg/dl , p<0.0002 ) , low-density lipoprotein levels ( Δ=-48.1 ± 31.7 versusΔ=1.9 ± 42.8 mg/dl , p<0.002 ) , dental mobility ( Δ=-0.17 ± 0.11 versusΔ=-0.06 ± 0.11 % , p<0.04 ) , and the distance from the crestal alveolar bone to the cemento-enamel junction ( Δ=-0.75 ± 0.7 versusΔ=0.09 ± 0.4 mm , p<0.0006 ) in the ATV group . CONCLUSIONS The results suggest that ATV might have beneficial effects on bone alveolar loss and tooth mobility in subjects with periodontal disease BACKGROUND The present r and omized , double-masked , placebo-controlled , parallel-arm study examines the impact of adjunctive subantimicrobial-dose doxycycline ( SDD ) on the local inflammatory response through cytokine and chemokine levels in gingival crevicular fluid ( GCF ) sample s from patients with chronic periodontitis . METHODS Forty-six patients with chronic periodontitis received scaling and root planing with or without adjunctive SDD . GCF sample s were collected and clinical parameters including probing depth , clinical attachment level , gingival index , and plaque index were recorded every 3 months for 12 months . GCF tumor necrosis factor-α , interleukin (IL)-6 , IL-4 , IL-10 , IL-13 , IL-17 , macrophage inhibitory protein 1α , macrophage inhibitory protein 1β , monocyte chemoattractant protein 1 , and regulated on activated normal T-cell expressed and secreted protein levels were determined by xMAP multiplex immunoassay . RESULTS Significant improvements were observed in all clinical parameters in both groups over 12 months ( P < 0.0125 ) , whereas the SDD group showed significantly better reduction in gingival index , probing depth , and gain in clinical attachment compared to the placebo group ( P < 0.05 ) . Decrease in IL-6 in the SDD group was significantly higher compared to the placebo group at 6 and 9 months in deep pockets ( P < 0.05 ) , whereas tumor necrosis factor-α was significantly reduced in moderately deep pockets ( P < 0.05 ) . SDD result ed in a stable IL-4 and IL-10 response while reducing the monocyte chemoattractant protein 1 levels at 3 months ( P < 0.05 ) . CONCLUSIONS These results show that SDD , as an
Output:
| AUTHORS ' CONCLUSIONS We found very low quality evidence that was insufficient to support or refute whether periodontal therapy can prevent the recurrence of CVD in the long term in patients with chronic periodontitis .
No evidence on primary prevention was found |
MS210951 | ***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 and Purpose — Thrombolysis with intravenous recombinant tissue plasminogen activator is an effective treatment for acute ischemic stroke , but the number of treatable patients is limited . The PRomoting ACute Thrombolysis in Ischemic StrokE ( PRACTISE ) trial evaluated the effectiveness of a multidimensional implementation strategy for thrombolysis with intravenous recombinant tissue plasminogen activator in acute ischemic stroke . Methods — The PRACTISE trial was a national multicenter cluster-r and omized controlled trial with r and omization after pairwise matching . Twelve hospitals , both urban and community , academic and nonacademic , in the Netherl and s participated . All patients admitted with stroke within 24 hours from onset of symptoms were registered . The intervention included 5 implementation meetings based on the Breakthrough Series model . The primary outcome was treatment with thrombolysis . Secondary outcomes were admission within 4 hours after onset of symptoms , death or disability at 3 months , and quality of life . Results — Overall 5515 patients were included in the study ' 308 patients ( 12.2 % ) in the control centers and 393 patients ( 13.1 % ) in the intervention centers were treated with thrombolysis ( adjusted OR , 1.25 ; 95 % CI , 0.93 to 1.68 ) . Among the 1657 patients with ischemic stroke admitted within 4 hours from onset , 391 ( 44.5 % ) of 880 in the intervention centers were treated with thrombolysis and 305 ( 39.3 % ) of 777 in the control centers ; the adjusted OR for treatment with thrombolysis was 1.58 ( 95 % CI , 1.11 to 2.27 ) . Conclusions — An intensive implementation strategy increases the proportion of patients with acute stroke treated with thrombolysis in real-life setting s. An apparently pivotal factor in the improvement of the treatment rate is better application of contraindications for thrombolysis Background and Purpose — An educational campaign by mass media has been associated with great increases in the knowledge about early symptoms of stroke . However , few studies were conducted with a controlled community intervention study . Methods — To clarify the effects of a 1-year television campaign for the whole population on improvement of knowledge about stroke symptoms in 2 cities , a campaign area and a control area in Japan were selected . Before and after the campaign , 1960 r and omly selected residents aged 40 to 74 years answered a telephone survey regarding knowledge of early stroke symptoms . We calculated the percentage and 95 % CIs of participants who correctly chose all 5 early symptoms of stroke in each area and in each year . Results — Before the campaign , 53 % of participants ( 95 % CI , 50%–55 % ) in the campaign area and 46 % ( 95 % CI , 44%–49 % ) in the control area correctly chose 5 early symptoms . After the 1-year television campaign , knowledge was significantly improved only in the campaign area ( campaign area , 63 % ; 95 % CI , 60%–66 % ; control area , 51 % ; 95 % CI , 48%–54 % ) . After sex stratification , only women showed improved knowledge of early symptoms . The audience rate for the campaign television programs was found to be higher in women than in men . Conclusions – A 1-year stroke educational television campaign effectively improved knowledge about early stroke symptoms among Japanese women aged 40 to 74 years . No impact was found among men in this age group . Future studies should examine the impact of this approach on stroke knowledge among younger individuals and whether there are any behavioral changes that contribute to earlier presentation for treatment BACKGROUND Many critical appraisal tools ( CATs ) exist for which there is little or no information on development of the CAT , evaluation of validity , or testing reliability . The proposed CAT was developed based on a number of other CATs , general research methods theory , and reporting guidelines but requires further study to determine its effectiveness . OBJECTIVES To establish a scoring system and to evaluate the construct validity of the proposed critical appraisal tool before undertaking reliability testing . METHODS Data obtained from this exploratory study along with information on the design of the proposed CAT were combined to evaluate construct validity using the St and ards for educational and psychological testing which consist of five types of evidence : test content , response process , internal structure , relations to other variables , and consequences of testing . To obtain data for internal structure and relations to other variables , the proposed CAT was analysed against five alternative CATs . A r and om sample of 10 papers from six different research design s across the range of health related research were selected , giving a total sample size of 60 papers . RESULTS In all research design s , the proposed CAT had significant ( p<0.05 , two-tailed ) weak to moderate positive correlations ( Kendall 's τ 0.33 - 0.55 ) with the alternative CATs , except in the Preamble category . There were significant moderate to strong positive correlations in the quasi-experimental ( τ 0.70 - 1.00 ) , descriptive/exploratory/observational ( τ 0.72 - 1.00 ) , qualitative ( τ 0.74 - 0.81 ) , and systematic review ( τ 0.62 - 0.82 ) design s and to a lesser extent in the true experimental ( τ 0.68 - 0.70 ) design . There were no significant correlations in the single system research design s. CONCLUSIONS Based on the results obtained , the theory on which the proposed CAT was design ed , and the objective of the proposed CAT there was enough evidence to show that inferences made from scores obtained from the proposed CAT should be sound OBJECTIVE Prolonged prehospital delay in persons experiencing acute coronary syndrome ( ACS ) remains a problem . Underst and ing which patients respond best to particular interventions design ed to decrease delay time would provide mechanistic insights into the process by which interventions work . METHODS In the PROMOTION trial , 3522 at-risk patients were enrolled from 5 sites in the United States ( 56.4 % ) , Australia and New Zeal and ; 490 ( N=272 intervention , N=218 control ) had an acute event within 2 years . Focusing on these 490 , we ( 1 ) identified predictors of a rapid response to symptoms , ( 2 ) identified intervention group subjects with a change in these predictors over 3 months of follow-up , and ( 3 ) compared intervention group participants with and without the favorable response pattern . Hypothesized predictors of rapid response were increased perceived control and decreased anxiety . Knowledge , attitudes , and beliefs were hypothesized to differ between responders and non-responders . RESULTS Contrary to hypothesis , responders had low anxiety and low perceived control . Only 73 ( 26.8 % ) subjects showed this pattern 3 months following the intervention . No differences in ACS knowledge , attitudes , or beliefs were found . CONCLUSION The results of this study challenge existing beliefs . PRACTICE IMPLICATION S New intervention approaches that focus on a realistic decrease in anxiety and perceived control are needed Background and Purpose — Only a small minority of acute stroke patients receive approved acute stroke therapy . We performed a community and professional behavioral intervention project to increase the proportion of stroke patients treated with approved acute stroke therapy . Methods — This study used a quasi-experimental design . Intervention and comparison communities were compared at baseline and during educational intervention . The communities were based in 5 nonurban East Texas counties . The multilevel intervention worked with hospitals and community physicians while changing the stroke identification skills , outcome expectations , and social norms of community residents . The primary goal was to increase the proportion of patients treated with intravenous recombinant tissue plasminogen activator ( rTPA ) from 1 % to 6 % of all cerebrovascular events in the intervention community . Results — We prospect ively evaluated 1733 patients and vali date d 1189 cerebrovascular events . Intravenous rTPA treatment increased from 1.38 % to 5.75 % among all cerebrovascular event patients in the intervention community ( P = 0.01 ) compared with a change from 0.49 % to 0.55 % in the comparison community ( P = 1.00 ) . Among the ischemic stroke patients , an increase from 2.21 % to 8.65 % was noted in the intervention community ( P = 0.02 ) . The comparison group did not appreciably change ( 0.71 % to 0.86 % , P = 1.00 ) . Of eligible intravenous rTPA c and i date s , treatment increased in the intervention community from 14 % to 52 % ( P = 0.003 ) and was unchanged in the comparison community ( 7 % to 6 % , P = 1.00 ) . Conclusions — An aggressive , multilevel stroke educational intervention program can increase delivery of acute stroke therapy . This may have important public health implication s for reducing disability on a national level Background and Purpose — Establishment of stroke centers , combined with accurate paramedic diagnosis and rapid transport , is essential to deliver acute stroke therapy . We wanted to measure and improve paramedic and hospital performance through implementation of the Brain Attack Coalition and American Stroke Association guidelines . Methods — Pre-intervention and active-intervention phases with parallel data measurement points were used . The study involved six hospitals comprising the majority of acute-stroke admissions in Houston , Tex . Hospital , paramedic , and patient data were collected prospect ively pre-intervention and during the active-intervention phase on all suspected acute-stroke patients admitted by Houston Fire Department-Emergency Medical Services . A multilevel educational intervention included paramedic , hospital , and community education . Paramedic diagnostic accuracy , hospital-performance efficiency , and thrombolytic treatment rates were the main outcome measures of the study . Results — Four hundred forty-six patients ( 74 per month ) were transported in the pre-intervention phase to participating hospitals ( 59.8 % of all suspected stroke patients transported city wide by Houston Fire Department — Emergency Medical Services ) , compared with 1072 patients ( 89 per month , or 68.7 % ) transported in the active-intervention phase ( P<0.001 ) . Accuracy of paramedic diagnosis of stroke increased from 61 % to 79 % . Admission within 2 hours of symptom onset increased from 58 % to 62 % ( P=0.002 ) . Thrombolysis rates increased in 4 of 6 centers , with 1 post- tissue plasminogen activator hemorrhage ( 3.7 % ) reported . Conclusions — A multilevel educational program improves rapid hospitalization and paramedic diagnostic accuracy and increases the number of patients presenting for evaluation within the 3-hour tissue plasminogen activator window . Stroke center development supports safe thrombolytic practice in community setting As part of the recruitment efforts for the National Institutes of Health Tissue Plasminogen Activator Pilot Study , public education and awareness campaigns were conducted to encourage early hospital arrival . We evaluated the change in arrival times during the course of the study for all stroke patients , including those who were not entered into study . Methods Data were gathered on all patients presenting within 24 hours of stroke onset to all of the study hospitals . Coincident with the start of the study , educational and promotional programs , which stressed signs and symptoms of stroke and the need to call 911 , were presented to physicians , paramedical personnel , and the public . The study was divided into four quartiles to analyze differences in time to hospital arrival and use of 911 . Results Of 2099 patients screened , time data were available on 1116 . During the course of the study , the mean time from symptom onset to hospital arrival declined significantly ( 3.2 hours versus 1.5 hours ) . Patients arrived for treatment sooner at community hospitals than at university/teaching hospitals . The use of 911 increased from 39 % in the first quartile of the study to 60 % in the fourth quartile . This was a consistent finding in all study sites . Increased use of 911 was seen almost exclusively in patients with nonhemorrhagic stroke . Conclusions Times from stroke onset to hospital arrival decreased significantly during the course of the National Institutes of Health Tissue Plasminogen Activator Pilot Study . Significantly increased use of 911 was the likely major explanation for the shortened arrival times . The decrease in arrival times may be a consequence of the public and professional education programs conducted at all study sites CONTEXT Poor public knowledge of stroke warning signs and risk factors limits effective stroke intervention and prevention . OBJECTIVE To examine temporal trends in public knowledge of stroke warning signs and risk factors . DESIGN AND SETTING Population -based r and om-digit telephone survey conducted in July-November 2000 among individuals in the greater Cincinnati , Ohio , region . PARTICIPANTS A total of 2173 survey respondents ( 69 % response rate ) were r and omly identified based on their demographic similarities to the ischemic stroke population with regard to age , race , and sex . MAIN OUTCOME MEASURES Spontaneous recall of at least 1 important stroke warning sign and 1 established stroke risk factor in comparison with findings from the same survey in 1995 . RESULTS In 2000 , 70 % of respondents correctly named at least 1 established stroke warning sign vs 57 % in 1995 ( P<.001 ) , and 72 % correctly named at least 1 established stroke risk factor vs 68 % in 1995 . Groups of individuals with the highest risk and incidence of stroke , such as persons at least 75 years old , blacks , and men , were the least knowledgeable about warning signs and risk factors . Television was the most frequently cited source of knowledge , 32 % in 2000 vs 24 % in 1995 ( P<.001 ) . CONCLUSIONS Public knowledge of stroke warning signs within the greater Cincinnati region has significantly improved from 1995 to 2000 , although knowledge
Output:
| Reporting of specific intervention design was suboptimal and impeded the identification of key intervention components for reducing patient delay .
The parallel delivery of public and professional interventions further limited the identification of successful intervention components .
The potential clinical benefits of public interventions are far-reaching , and the challenge remains in translating knowledge improvements and correct behavioral intentions to appropriate behavior when stroke occurs |
MS210952 | ***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 this study was to evaluate the periodontal tissues of patients with m and ibular fixed retention for long or short periods of time . A total of 64 individuals were selected for this study using the following inclusion criteria : long-term lingual fixed retention ; identical type of lingual fixed retainer bonded with the same material s ; no cavities , restorations , or fractures of the m and ibular anterior teeth ; absence of habits and occlusal interferences ; and canine guidance bilaterally . The result ant sample comprised 32 patients ( mean age 25 years ) who had been in retention for a mean period of 9.65 years ( range 9 - 11 years ) and an equal number retained for a period between 3 and 6 months . Plaque , gingival , and calculus indices , probing pocket depth , marginal recession , and bone level at the m and ibular six anterior teeth were recorded for both groups . Demographic , clinical , and radiographic data were investigated with conventional descriptive statistics . Comparisons of the different variables between the two participant groups ( long- and short-term retention ) were carried out using a Mann-Whitney test for indices ( plaque , gingival , and calculus ) , and a Fisher 's exact test ( two sided ) for the remaining variables . No significant difference was found with respect to the plaque and gingival indices and bone level between the two groups . The long-term group presented higher calculus accumulation , greater marginal recession , and increased probing depth ( P < 0.05 ) . The results of this study raise the question of the appropriateness of lingual fixed retainers as a st and ard retention plan for all patients regardless of their attitude to dental hygiene . They also emphasize the importance of individual variability and cautious application of retention protocol s after a thorough consideration of issues related to the anatomy of tissues and oral hygiene Background Most orthodontists believe that fixed retainers are necessary to maintain ideal dental relationships . However , untoward side effects might result from their long-term placement . The aim of this study was to evaluate the clinical and radiographic effect of two commonly used fixed retainers on the health of the periodontium . Methods Thirty patients were r and omly divided into two groups to receive either a fiber-reinforced composite retainer or a spiral wire retainer extended on the lingual surfaces of both maxillary and m and ibular arches from canine to canine . Periapical radiographs were obtained from the patients at the time of placement of the retainers and after the 6-month period to assess the radiographic conditions of the periodontium . Clinical examination was carried out at the same two time intervals . Results Even though there were no significant differences between the two groups of study at the beginning of the trial , there were statistically significant differences after the 6-month follow-up regarding the main outcomes of the study . Nearly all indices showed to deteriorate after 6 months in the fiber-reinforced group , while in the spiral wire group , this was not the case . As for the secondary outcomes , radiographic examination did not reveal any statistically significant differences after 6 months or between the two groups . Conclusions It can be concluded that spiral wire retainers elicit less detrimental periodontal response in the short-term follow-up compared to fiber-reinforced composite retainers as revealed by the primary outcomes of the study .Trial registration Clinical Trials.gov : Abstract Background and Aim : In recent years , fixed lingual retainers have been gaining importance in relapse prevention . The aim of this prospect i ve , r and omized study was to compare different types of fixed retainers used for stabilization of the lower anterior segment with respect to detachment rate , relapse , periodontal and oral hygiene problems , as well as subjective patient discomfort . Patients and Method : Two types of fixed , customized canine-to-canine retainers ( attached to six teeth ) with wire diameters of 0.0215 ” and 0.0195 ” as well as one type of prefabricated canine- and -canine retainer ( bonded to two teeth ) were investigated in a total of 103 patients . Some retainers wer inserted under dry field conditions using a rubber dam , and the others under relatively dry conditions using cotton rolls . In addition , two types of composite , Heliosit ® and Concise ™ , were compared . Results : The canine- and -canine retainer displayed an 18 % detachment rate , a value significantly lower than the 29 % determined for the 0.0195 ” canine-to-canine retainers . The 0.0215 ” canine-to-canine retainer had the highest detachment rate ( 53 % ) . The 37 % detachment rate with dry field bonding was slightly higher than the 32 % with relatively dry field bonding . Comparison of the composites showed a significantly higher detachment rate for Heliosit ® ( 73 % ) than for Concise ™ ( 27 % ) . Plaque accumulation increased with all retainer types in the course of the study , but with no significant inter-group differences . Tooth position with canine-to-canine retainers showed a good degree of stability . The canine- and -canine retainer induced frequent relapse of incisors not bonded to the retainer . In view of their higher rate of subjective discomfort , canine- and -canine retainers were given a significantly poorer rating than their canine-to-canine counterparts . ZusammenfassungHintergrund und Ziel : In den letzten Jahren gewinnen die Lingualretainer zur Rezidivprophylaxe an Bedeutung . Ziel der Studie war es , prospektiv und r and omisiert verschiedene permanente Retainersysteme zur Stabilisierung der Unterkieferfront in Bezug auf Ablöseraten , Rezidive , parodontale und mundhygienische Probleme sowie subjektive Belastungen zu vergleichen . Patienten und Method e : Es wurden zwei an sechs Zähnen adhäsiv befestigte ( Sechspunktretainer ) der Drahtstärken 0,0215 ” und 0,0195 ” und ein konfektionierter , an zwei Zähnen befestigter Retainer ( Zweipunktretainer ) verwendet . Ein Teil der Retainer wurde unter Kofferdam eingesetzt , ein and erer unter relativer Trockenlegung mit Watterollen . Des Weiteren wurden die Komposite Heliosit ® Orthodontic und Concise ™ Orthodontic verglichen . Ergebnisse : Der Zweipunktretainer wies mit 18 % eine signifikant geringere Ablöserate auf als der Sechspunktretainer der Drahtstärke 0,0195 ” mit 29 % . Der Sechspunktretainer der Stärke 0,0215 ” hat mit 53 % die höchste Ablöserate . Die Ablösungsrate lag bei absoluter Trockenlegung mit 37 % geringfügig höher als bei relativer Trockenlegung mit 32 % . Der Vergleich der beiden Komposite ergab eine signifikant größere Ablösungsrate für Heliosit ® ( 73 % ) gegenüber Concise ™ ( 27 % ) . Die Plaqueakkumulation nahm bei allen drei Retainertypen i m Verlauf der Studie zu ohne signifikante Unterschiede zwischen den einzelnen Retainertypen . Die Zahnstellung blieb bei den beiden Sechspunktretainern weitgehend stabil . Bei dem Zweipunktretainer kam es gehäuft zu Rezidiven der nicht gefassten Schneidezähne . Zweipunktretainer schnitten durch die höhere Angabe subjektiver Beschwerden bei der Fragebogenauswertung zur Patientenbelastung signifikant schlechter ab als Sechspunktretainer BACKGROUND Different types and diameters of wire are used in bonded lingual retainers . Some clinicians bond a small diameter multistr and wire to each tooth , while other clinicians bond a large diameter wire to the lingual surfaces of the lower canines . AIM To compare the gingival health , plaque accumulation , tooth stability and integrity of multistr and wire and round wire bonded lingual retainers . METHODS Sixty-two subjects , who had completed treatment and who required fixed retention for the lower anterior segment , were assigned to either the Round wire retainer group or the Multistr and wire retainer group . In the Round wire retainer group , a 0.036 inch round , stainless steel wire was bonded to the lingual surfaces of both lower canines . The Multistr and retainer group had a 0.015 inch multistr and wire bonded to the lingual surfaces of all lower anterior teeth . At least 12 months after debonding , the subjects were recalled and the following variables were recorded : Oral Hygiene Index ( OHI ) , Plaque Index ( PI ) of the lower anterior teeth , Gingival Index ( GI ) of the lower anterior teeth , Irregularity Index ( IRI ) of the lower anterior teeth , and the number of broken retainers . RESULTS There were no significant differences between the PI ( p = 0.165 ) and GI ( p = 0.150 ) of the two groups . More plaque was found on the distal surfaces of the lower anterior teeth in the group with multistr and wire retainers ( p = 0.02 ) . The lower anterior teeth were significantly more irregular in the group with round wire retainers compared to the group with multistr and wire retainers ( p = 0.002 ) . Although the multistr and wire retainers fractured more frequently than the round wire retainers the difference was not statistically significant ( p = 0.325 ) . CONCLUSION More plaque accumulated on the distal surfaces of the lower anterior teeth in subjects with multistr and wire retainers than in subjects with round wire retainers . Multistr and wire retainers were better at maintaining incisor alignment than single span , round wire retainers The present study was performed to test whether bonded , orthodontic canine-to-canine retainers made of spiral wire tended to accumulate more plaque than retainers made of plain wire , and whether the presence of such retainers caused any damage to the teeth involved . 44 patients were classified in eight strata according to age , gender and gingival status . From each stratum , the patients were r and omly divided into 4 groups , each of which received either retainers made of thick plain wire bonded only to the canines , thick twisted wired bonded only to the canines , thin twisted wire bonded to each tooth or removable retainers . Accumulation of plaque and calculus along the gingival margin and gingival inflammation were scored in lingual areas from canine to canine at time of fixed appliance removal and again 4 months after retainer insertion . In addition , accumulation of plaque and calculus and development of caries along the retainer wires were scored after 4 months . The results revealed no differences between the groups for any of the variables . No differences in accumulation of plaque was found between baseline and follow-up examinations . Gingival bleeding was scored less frequently after 4 months in retention than at time of debonding White spot or areas of decalcification are carious lesions of varying extent . The incidence and severity of white spots after a full term of orthodontic treatment were studied among patients in the separate private practice s of two of the authors . To establish a base line of comparison , the presence of white spots in a r and om sample of untreated persons was observed . The incidence of white spots among patients treated by a multibonded technique was recorded at the time of debonding . In addition , white spots were sought in the before- and after-treatment Kodachrome slides of persons whose maxillary incisors had been h and ed . It was found that individual teeth , b and ed or bonded , exhibited significantly more white spot formation than was found in the control group . For the teeth studied , there was no difference in white spot formation in those that were b and ed or bonded . The labiogingival area of the maxillary lateral incisors had the highest incidence of white spots . When studied by segments , the highest incidence occurred among the maxillary incisors ; the lowest was in the maxillary posterior segment . No white spots were found on the lingual surfaces of m and ibular canines and incisors after prolonged use of a canine-to-canine bonded retainer . These findings suggest a relationship between resistance to white spot formation and the rate of salivary flow . Despite the lack of any preventive fluoride program among the study groups , 50 % of the patients demonstrated resistance to white spot formation . The obvious degree of latrogenic damage during orthodontic treatment suggests the need for preventive programs using fluoride . Further clinical research is needed
Output:
| Regarding comfort , no clear differences were identified .
Conclusions There is not enough scientific evidence to support or not an association between FR design and gingival health , flossing frequency , or patient comfort . |
MS210953 | ***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: In a multinational , double-blind , placebo-controlled trial ( NCT00474058 ) , 287 subjects with Parkinson 's disease ( PD ) and unsatisfactory early-morning motor symptom control were r and omized 2:1 to receive rotigotine ( 2–16 mg/24 hr [ n = 190 ] ) or placebo ( n = 97 ) . Treatment was titrated to optimal dose over 1–8 weeks with subsequent dose maintenance for 4 weeks . Early-morning motor function and nocturnal sleep disturbance were assessed as co primary efficacy endpoints using the Unified Parkinson 's Disease Rating Scale ( UPDRS ) Part III ( Motor Examination ) measured in the early morning prior to any medication intake and the modified Parkinson 's Disease Sleep Scale ( PDSS-2 ) ( mean change from baseline to end of maintenance [ EOM ] , last observation carried forward ) . At EOM , mean UPDRS Part III score had decreased by −7.0 points with rotigotine ( from a baseline of 29.6 [ st and ard deviation ( SD ) 12.3 ] and by −3.9 points with placebo ( baseline 32.0 [ 13.3 ] ) . Mean PDSS-2 total score had decreased by −5.9 points with rotigotine ( from a baseline of 19.3 [ SD 9.3 ] ) and by −1.9 points with placebo ( baseline 20.5 [ 10.4 ] ) . This represented a significantly greater improvement with rotigotine compared with placebo on both the UPDRS Part III ( treatment difference : −3.55 [ 95 % confidence interval ( CI ) −5.37 , −1.73 ] ; P = 0.0002 ) and PDSS-2 ( treatment difference : −4.26 [ 95 % CI −6.08 , −2.45 ] ; P < 0.0001 ) . The most frequently reported adverse events were nausea ( placebo , 9 % ; rotigotine , 21 % ) , application site reactions ( placebo , 4 % ; rotigotine , 15 % ) , and dizziness ( placebo , 6 % ; rotigotine 10 % ) . Twenty-four-hour transdermal delivery of rotigotine to PD patients with early-morning motor dysfunction result ed in significant benefits in control of both motor function and nocturnal sleep disturbances . © 2010 Movement Disorder 1 . Insomnia is an even more frequent complaint in elderly patients with Parkinson 's disease than might be expected from the effect of age alone on sleep . 2 . A double-blind , placebo-controlled trial in eleven patients with Parkinson 's disease of mean ( s.d . ) age 80(5 ) years , showed that nocturnal dosing with levodopa produced a clinical ly significant improvement in sleep both as assessed subjectively and by measurement of number of spontaneous moves in bed . 3 . Despite the long interval between tablet administration and morning assessment , walking time was faster on mornings following active treatment This open-label study ( NCT00243945 ) investigated the efficacy of rotigotine transdermal system in 54 Parkinson ’s disease ( PD ) patients with unsatisfactory control of early morning motor impairment and sleep disturbances . Rotigotine dose was up titrated for 8 weeks and maintained for 4 weeks . Mean rotigotine dose at end of maintenance was 11.83 mg/24 h ( SD 3.86 ) . Patients had two overnight hospital stays at baseline and end of treatment during which early morning motor performance was assessed , prior to first morning dose of regular oral antiparkinsonian medication . Rotigotine improved mean Unified Parkinson ’s Disease Rating Scale ( UPDRS ) part III score by −9.3 points , mean Timed Up and Go test duration by −1.4 s and mean morning finger tapping by 26.5 taps/min ; 46 % of patients were considered responders ( ≥30 % improvement of UPDRS III ) . Mean Nocturnal Akinesia , Dystonia and Cramps Sum Score was reduced by 61 % ; mean number of nocturias decreased by 32 % . Rotigotine also improved sleep quality . These results suggest a role for rotigotine in treatment of nocturnal and early morning motor disabilities in PD patients We developed a mobility detection system to analyze pressure changes over time during side-turns in 29 healthy volunteers ( 17 males and 12 females ) with a mean age of 46.1 ± 19.64 years ( ranging from 23 to 86 years ) in order to determine the effect of gender , age , and BMI on performance during bed postural change . Center of gravity ( COG ) location , peak pressure of counteraction , and time to reach peak pressure were the main outcomes used to gauge the ability to make a spontaneous side-turn . Men exhibited significantly higher side-turning force ( P = 0.002 ) and back-turning force ( P = 0.002 ) compared with women . Subjects with BMI ≥27 kg/m2 had significantly higher side-turning force ( P = 0.007 ) and back-turning force ( P = 0.007 ) compared with those with BMI < 27 kg/m2 . After adjusting for other covariates , age positively correlated with back-turning time ( P = 0.033 ) and negatively correlated with side-turning speed ( P = 0.005 ) , back-turning speed ( P = 0.014 ) , side-turning force ( P = 0.010 ) , and back-turning force ( P = 0.016 ) , respectively . Turning times negatively correlated with time to reach peak pressure ( P = 0.008 ) . Our system was effective in detecting changes in turning swiftness in the bed-ridden subject We examined the effects of supplemental st and ard carbidopa/levodopa ( Std-L ) on early morning akinesia in patients with Parkinson 's disease ( PD ) who were being treated with sustained-release carbidopa/levodopa ( L-CR ) . We compared plasma dopa levels and clinical response in 15 PD patients after a dose of Std-L and L-CR ( 2 hours later ) and after a dose of L-CR and placebo in a double-blind , placebo-controlled , crossover study . Plasma dopa levels , total motor score , walking time , and finger tapping time were assessed every 15 minutes for the first 2 hours and then every 30 minutes for the next 3 hours . The time of onset in clinical benefit was significantly earlier with Std-L ( 47 minutes , range 15 to 75 minutes ) as the first dose as compared with L-CR ( 58 minutes , range 30 to 105 minutes ) . Similarly , there was a significant difference in the peak plasma dopa levels ( Cmax ) and the time to reach peak plasma dopa levels ( Tmax ) with administration of Std-L ( Tmax 36 minutes ; Cmax 1,501 mu g/ml ) as compared with L-CR ( Tmax 111 minutes , Cmax 1,260 mu g/ml ) . There was no significant difference in dyskinesias between the two treatment arms . An initial morning dose of Std-L alleviates the problem of delayed-onset clinical response that commonly occurs with L-CR . NEUROLOGY 1996;46 : 1059 - Objectives ‐ Nocturnal disabilities leading to fragmented sleep arising from parkinsonian off period related complications are common , under‐reported and are difficult to treat . In this study , we evaluate the use of nocturnal continuous subcutaneous overnight apomorphine infusion in Parkinson 's disease and restless legs syndrome . Methods ‐ Six parkinsonian patients and 2 patients with restless legs syndrome with nocturnal disabilities refractory to conventional oral therapy were assessed using a sleep diary while on st and ard treatment and during nocturnal apomorphine infusion . Three patients agreed to assessment s during placebo infusion with normal saline . Results ‐ Apomorphine led to a dramatic reduction of nocturnal awakenings , nocturnal off periods , pain , dystonia and nocturia in parkinsonian patients . In patients with restless legs syndrome , apomorphine reduced nocturnal discomfort , reduced leg movements and improved pain and spasm scores significantly . Placebo infusion reproduced pain , nocturnal spasms and sleep disruption . Conclusion ‐ This study suggests that overnight apomorphine infusion may be effective in overcoming refractory nocturnal disabilities in selected patients with Parkinson 's disease and restless legs syndrome Objective : The aim of this research is to characterize further the potential motor and non-motor benefits of rotigotine reported in the double-blind , placebo-controlled RECOVER trial primary publication , by performing a post hoc exploratory analysis of patient status ( symptom improvement/worsening ) . Methods : Full RECOVER trial method ological details have already been reported . The post hoc analyses presented here are done on individual items of the PDSS-2 and PDQ-8 for all patients and two subgroups ( baseline symptomatic and highly symptomatic patients ) . Results : Ten PDSS-2 and five PDQ-8 items show significant mean treatment difference versus placebo . In the overall population , items that most favor rotigotine in percentage of patients with improvement are ‘ limb pain causes waking ’ and ‘ uncomfortable in bed due to immobility ’ for PDSS-2 ; for PDQ-8 , rotigotine is most favored in ‘ difficulty dressing ’ , ‘ felt depressed ’ and ‘ difficulty getting around in public ’ . Among symptomatic and highly symptomatic patients , the PDSS-2 items that most favor rotigotine are both indicators of pain . On the PDQ-8 , the two items most favored in symptomatic patients are ‘ difficulty dressing ’ and ‘ embarrassed in public due to PD ’ , and in the highly symptomatic subgroup ‘ difficulty dressing ’ and ‘ difficulty getting around in public ’ . Conclusion : Though this trial was not powered for statistical subgroup analysis , these post hoc results indicate that treatment with rotigotine may benefit patients with sleep , pain , mood and quality -of-life issues BACKGROUND The LARGO study demonstrated that rasagiline 1 mg/day as adjunct to levodopa significantly reduces OFF time to the same magnitude as adjunct entacapone . This sub study of LARGO aim ed to assess the effect of rasagiline and entacapone on the motor symptoms of PD during the practically defined OFF state . METHODS LARGO was a r and omized , double-blind , multicenter trial that assessed the efficacy and safety of rasagiline ( 1 mg/day ) , entacapone ( 200 mg with each levodopa dose ) , and placebo in 687 levodopa-treated PD patients with motor fluctuations . A sub study of LARGO measured UPDRS motor scores in the practically defined OFF state in 32 rasagiline , 36 entacapone , and 37 placebo patients . RESULTS Treatment with rasagiline produced a significant improvement over placebo of 5.64 units in UPDRS motor OFF score ( P = 0.013 vs. placebo ) . By contrast , the effect of adjunct entacapone was not significant ( P = 0.14 vs. placebo ) . Whereas rasagiline also showed a trend in reducing the UPDRS-ADL OFF score ( P = 0.058 vs. placebo ) , no such trend was noted for entacapone ( P = 0.26 vs. placebo ) . Retrospective analysis , using the Bonferroni correction , of UPDRS motor subdomains further revealed that rasagiline , but not entacapone , significantly improved bradykinesia ( P < 0.001 ) and showed trends for improvements in facial expression , speech , and axial impairment during OFF time . CONCLUSIONS This study provides the first objective ly measured evidence that adjunct rasagiline 1 mg/day is effective in reducing the severity of motor symptoms in the OFF state . This suggests a continuous effect of rasagiline 1 mg/day throughout the day and night and is consistent with its extended duration of therapeutic action Clinical response to a new galenic formulation of levodopa plus benserazide , Madopar HBS , was studied in 25 fluctuating parkinsonians . This open study was planned in two phases . In the first phase , the administering of HBS alone result ed in a surprisingly high number of dropouts . In the second phase , Madopar st and ard in association with Madopar HBS , the follow-up period was 24 months . A stable long-lasting improvement in predictable fluctuations and their severity was maintained for the whole period without any change in drug dose . Nocturnal and early morning akinesia improved too . The study shows that Madopar HBS plus Madopar st and ard is effective in producing a prolonged and stable response in parkinsonian fluctuating patients BACKGROUND The 24-week , double-blind Efficacy and Safety Evaluation in PD-Adjunct ( EASE-PD Adjunct ) study r and omized patients with advanced Parkinson 's disease ( PD ) suboptimally controlled with levodopa to once-daily placebo or adjunctive ropinirole prolonged release ( 2 - 24 mg/day ) . We investigated the effect of ropinirole prolonged release on nocturnal symptoms in these patients . METHODS Total and grouped item PD Sleep Scale ( PDSS ) scores were analyzed post hoc in patients with baseline PDSS total scores ≤ 100 ( troublesome nocturnal symptoms ) and > 100 . RESULTS Baseline PDSS total score was ≤ 100 in 93 of 198 ( 4
Output:
| Several lines of evidence support the use of long-acting drugs or by continuous administration of short-acting agents to control symptoms . |
MS210954 | ***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 —Steroid administration during cardiopulmonary bypass is thought to improve cardiopulmonary function by modulating bypass-related inflammation . This study was design ed to compare preoperative and intraoperative methylprednisolone ( MP ) to intraoperative MP alone with respect to postbypass inflammation and clinical outcome . Methods and Results —Twenty-nine pediatric patients undergoing bypass procedures were r and omly assigned to receive preoperative and intraoperative MP ( 30 mg/kg 4 hours before bypass and in bypass prime , n=14 ) or intraoperative MP only ( 30 mg/kg , n=15 ) . Myocardial inflammatory mediator mRNA expression was determined in paired atrial biopsies ( before and after bypass ) by ribonuclease protection . Before and after bypass , serum IL-6 and IL-10 were measured by ELISA . Postoperative outcome was assessed by intubation time , CICU length of stay , fluid balance , arterio-venous O2 difference ( & Dgr;A−Vo2 ) , and inotrope requirements . Compared with intraoperative MP alone , combined preoperative and intraoperative MP was associated with reduced myocardial mRNA expression for IL-6 , MCP-1 , and ICAM-1 both before and after bypass ( P < 0.05 ) . Patients who received combined steroids had lower serum IL-6 and increased IL-10 at end-bypass ( P < 0.05 ) , although differences were negligible by 24 hours . Combined MP treatment was associated with reduced fluid requirements , lower body temperature , and lower & Dgr;A−Vo2 for the first 24 hours after surgery ( P < 0.05 ) , along with trends toward improvement in other clinical outcomes . Conclusions —Compared with intraoperative steroid treatment , combined preoperative and intraoperative steroid administration attenuates inflammatory mediator expression more effectively and is associated with improved indexes of O2 delivery in the first 24 hours after congenital heart surgery . These findings need to be confirmed in a larger multicenter trial BACKGROUND Corticosteroids are widely used in pediatric open-heart surgery to reduce systemic inflammatory response and to mediate possible cardioprotective effects . However , the optimal dosing of corticosteroids is unknown and their administration varies considerably between different institutions . METHODS Forty neonates undergoing open-heart surgery were r and omized in a double-blind fashion equally into 2 groups . After the induction of anesthesia , 1 group received 30 mg/kg intravenous methylprednisolone and the other a placebo . Concentrations in plasma of interleukin 6 ( IL-6 ) , IL-8 , IL-10 , free methylprednisolone and total methylprednisolone were obtained for the following : ( 1 ) at anesthesia induction before the study drug was administered ; ( 2 ) 30 minutes on cardiopulmonary bypass ; ( 3 ) 5 minutes after protamine administration ; and ( 4 ) 6 hours after weaning from cardiopulmonary bypass . Troponin T was measured at time points T1 , T3 , T4 , and also at 6:00 on the first postoperative morning . Physiological and clinical outcome parameters were also recorded . RESULTS Intravenous methylprednisolone result ed in high plasma drug concentrations that peaked at T2 . Methylprednisolone significantly lowered concentrations of proinflammatory cytokines IL-6 and IL-8 and raised levels of anti-inflammatory IL-10 . No significant differences in troponin T levels were detected . Blood glucose levels were significantly higher in the methylprednisolone group , and patients in this group received more often insulin therapy than controls . No significant differences were observed in other clinical or physiological outcome measurements . CONCLUSIONS Intravenous 30 mg/kg methylprednisolone administered before cardiopulmonary bypass result ed in high effective plasma drug concentrations and a decreased inflammatory response . However , no cardioprotective effect or better clinical outcome was noticed OBJECTIVE To determine the influence of methylprednisolone on the cytokine balance during cardiac surgery . DESIGN Prospect i ve , r and omized , nonblinded study . SETTING University hospital . PATIENTS Twenty-one patients on cardiopulmonary bypass undergoing aortocoronary bypass surgery . INTERVENTIONS According to a r and omized sequence , the patients either received methylprednisolone ( 30 mg/kg ) [ corrected ] before cardiopulmonary bypass and before declamping of the aorta ( MPS group , n = 11 ) or received nothing ( control group , n = 10 ) . MEASUREMENTS AND MAIN RESULTS Serum proinflammatory cytokines ( interleukin [IL]-8 , IL-6 ) and anti-inflammatory cytokines ( IL-10 , IL-1ra ) were measured by enzyme-linked immunosorbent assays . Serum IL-6 and IL-8 concentrations in the control group ( 15.2 + /- 4.1 and 14.1 + /- 1.9 pg/mL , preoperatively ) increased to 242 + /- 70.1 and 97.3 + /- 18.3 pg/mL at 60 mins after declamping of the aorta ( p < .01 , p < .01 , respectively ) . The increases were greater than those from 2.5 + /- 0.6 and 2.5 + /- 0.5 pg/mL to 109.5 + /- 29.0 and 33 + /- 4.1 pg/mL in the MPS group for IL-6 and IL-8 , respectively . Serum IL-10 concentrations increased significantly 60 mins after declamping of the aorta compared with its preoperative value in the two groups ( the control group , from 1.0 + /- 0 to 537.9 + /- 61.7 pg/mL ; the MPS group , from 0.3 + /- 0.2 to 654.9 + /- 24 pg/mL [ p < .01 , p < .01 , respectively ] ) . No difference was found between the two groups . Similarly , serum IL-1ra concentrations in the two groups increased the preoperative value in the control group from 304 + /- 120 to 44,374 + /- 14,631 pg/mL and in the MPS group from 616.5 + /- 109.6 to 35,598 + /- 9,074 pg/mL at 60 mins after declamping of the aorta ( p < .01 , p < .01 , respectively ) . There was no difference between the two groups . CONCLUSIONS Methylprednisolone reduces the production of IL-6 and IL-8 but not that of IL-10 and IL-1ra . These results suggest that one of the mechanisms of the cytoprotective effect of methylprednisolone may be to make changes in the proinflammatory and anti-inflammatory cytokine balance Introduction Extracorporeal circulation induces hemostatic alterations that lead to inflammatory response ( IR ) and postoperative bleeding . Tranexamic acid ( TA ) reduces fibrinolysis and blood loss after cardiopulmonary bypass ( CPB ) . However , its effects on IR and vasoplegic shock ( VS ) are not well known and elucidating these effects was the main objective of this study . Methods A case control study was carried out to determine factors associated with IR after CPB . Patients undergoing elective CPB surgery were r and omly assigned to receive 2 g of TA or placebo ( 0.9 % saline ) before and after intervention . We performed an intention-to-treat analysis , comparing the incidence of IR and VS . We also analyzed several biological parameters related to inflammation , coagulation , and fibrinolysis systems . We used SPSS version 12.2 for statistical purpose s. Results In the case control study , 165 patients were studied , 20.6 % fulfilled IR criteria , and the use of TA proved to be an independent protective variable ( odds ratio 0.38 , 95 % confidence interval 0.18 to 0.81 ; P < 0.01 ) . The clinical trial was interrupted . Fifty patients were r and omly assigned to receive TA ( 24 ) or placebo ( 26 ) . Incidence of IR was 17 % in the TA group versus 42 % in the placebo group ( P = 0.047 ) . In the TA group , we observed a significant reduction in the incidence of VS ( P = 0.003 ) , the use of norepinephrine ( P = 0.029 ) , and time on mechanical ventilation ( P = 0.018 ) . These patients showed significantly lower D-dimer , plasminogen activator inhibitor 1 , and creatine-kinase levels and a trend toward lower levels of soluble tumor necrosis factor receptor and interleukin-6 within the first 24 hours after CPB . Conclusion The use of TA attenuates the development of IR and VS after CPB.Trial registration numberIS RCT N05718824 BACKGROUND Anti-inflammatory treatment with glucocorticoids during cardiopulmonary bypass can reduce inflammatory mediator release , but the effects of glucocorticoid on outcome are controversial . METHODS We studied the effects of dexamethasone on clinical course , C-reactive protein , von Willebr and factor antigen ( vWf : Ag ) and S100B in a r and omized masked study of children after open cardiac surgery . Twenty children weighing > 10 kg received dexamethasone ( 1 mg kg(-1 ) ) and 20 controls received saline after induction of anaesthesia . We measured vWf : Ag as a marker of endothelial activation , S100B as a marker of cerebral protein release and C-reactive protein as a marker of inflammatory activity . Oxygenation , body temperature , fluid balance , leucocyte and platelet counts , days in the intensive care unit ( ICU ) and days on mechanical ventilation were noted . RESULTS Dexamethasone decreased C-reactive protein concentration on the first postoperative day ( P<0.05 ) , but did not affect the release of vWf : Ag or S100B . There was no significant difference in oxygenation , body temperature , fluid balance , leucocyte and platelet counts , days in the ICU or days on mechanical ventilation between the placebo and dexamethasone-treated groups . CONCLUSION Administration of dexamethasone before cardiopulmonary bypass for paediatric cardiac surgery decreased the inflammatory response , but did not affect the immediate features after surgery or changes in vWf : Ag or S100B OBJECTIVE A heightened inflammatory response occurs after cardiac surgery . The perioperative use of glucocorticoids has been advocated as a method to improve postoperative outcomes . R and omized prospect i ve studies to quantify the effect of methylprednisolone on perioperative outcomes in neonatal cardiac surgery have not been performed . We sought to determine whether preoperative methylprednisolone would improve postoperative recovery in neonates requiring cardiac surgery . METHODS Neonates scheduled for cardiac surgery were r and omly assigned to receive either 2-dose ( 8 hours preoperatively and operatively , n = 39 ) or single-dose ( operatively , n = 37 ) methylprednisolone ( 30 mg/kg per dose ) in a prospect i ve double-blind trial . The primary outcome was the incidence of low cardiac output syndrome ( st and ardized score ) or death 36 hours postoperatively . Secondary outcomes were death at 30 days , interleukin-6 levels , inotropic score , fluid balance , serum creatinine , and intensive care unit and hospital stay . RESULTS Preoperative plasma levels of the inflammatory cytokine interleukin-6 were reduced by 2-fold ( P < .001 ) in the 2-dose methylprednisolone group , consistent with the anti-inflammatory effects of methylprednisolone . However , the incidence of low cardiac output syndrome was 46 % ( 17/37 ) in the single-dose and 38 % ( 15/39 ) in the 2-dose methylprednisolone groups ( P = .51 ) . Two-dose methylprednisolone was associated with a higher serum creatinine ( 0.61 ± 0.18 mg/dL vs 0.53 ± 0.12 mg/dL , P = .03 ) and poorer postoperative diuresis ( -96 ± 49 mL , P = .05 ) . Inotropic requirement , duration of mechanical ventilation , intensive care unit , and hospital stay did not differ between the 2 groups . CONCLUSIONS Combined preoperative and intraoperative use of glucocorticoids in neonatal cardiac surgery does not favorably affect early clinical outcomes and may exacerbate perioperative renal dysfunction Cardiopulmonary bypass ( CPB ) is associated with a systemic inflammatory response . Pre-bypass steroid administration may modulate the inflammatory response , result ing in improved postoperative recovery . We performed a prospect i ve study in the departments of cardiovascular surgery and pediatric intensive care medicine of two university hospitals that included 50 infants who underwent heart surgery . Patients received either prednisolone ( 30 mg/kg ) added to the
Output:
| Despite a demonstrated attenuation of cardiopulmonary bypass-induced inflammatory response by steroid administration , a systematic review of r and omized controlled trials performed so far reveals that steroid administration has potential clinical advantages ( lower mortality and significant reduction of renal function deterioration ) . |
MS210955 | ***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 the present study was to investigate aspects of coagulation and fibrinolysis during knee arthroplasties in order to find out . 1 . whether an increased fibrinolysis is correlated to an increased blood loss 2 . whether there is a difference in markers for coagulation and fibrinolysis in peripheral venous blood compared to those in blood from the wounds 3 . whether the administration of tranexamic acid modifies the fibrinolytic response . Twenty-four patients were included . Twelve patients were given tranexamic acid intravenously at the end of the operation . The dose was repeated three hours later . The other 12 patients were given an equivalent amount of placebo . The administration was r and omised and double-blind . Levels of prothrombin fragments 1 + 2 , D-dimers , plasminogen , alpha 2-antiplasmin , tissue plasminogen activator ( tPA ) , and plasminogen activator inhibitor ( PAI-1 ) in venous blood were investigated just before the operation , at the end of the operation and three hours later . At the end of the operation blood for analysis was also drawn from the wound . Coagulation and fibrinolysis was activated during and after surgery . The activation was significantly higher in blood from the wounds than in peripheral venous blood . We found no direct correlation between the degree of fibrinolysis and blood loss . The administration of tranexamic acid reduced fibrinolysis in the wounds but not in peripheral venous blood . The postoperative blood loss was reduced by half The aim of this r and omized prospect i ve study was to clarify risks associated with a drain-clamping method using tranexamic acid and carbazochrome sodium sulfonate hydrate after total knee arthroplasty ( TKA ) . Subjects comprised 100 patients scheduled to undergo TKA , r and omized into 2 groups : 50 patients received the drain-clamping method using tranexamic acid and carbazochrome sodium sulfonate hydrate and 50 patients received drain-clamping with saline . Although bleeding volume was significantly lower in the group with tranexamic acid and carbazochrome sodium sulfonate hydrate , risk of asymptomatic deep venous thrombosis as detected by ultrasonography was comparable between groups . Tranexamic acid and carbazochrome sodium sulfonate hydrate in the drain-clamping method help reduce bleeding after TKA without increasing the risk of deep venous thrombosis BACKGROUND Total knee arthroplasty ( TKA ) is often carried out using a tourniquet and shed blood is collected in drains . Tranexamic acid decreases the external blood loss . Some blood loss may be concealed , and the overall effect of tranexamic acid on the haemoglobin ( Hb ) balance is not known . METHODS Patients with osteoarthrosis had unilateral cemented TKA using spinal anaesthesia . In a double-blind fashion , they received either placebo ( n=24 ) or tranexamic acid 10 mg kg(-1 ) ( n=27 ) i.v . just before tourniquet release and 3 h later . The decrease in circulating Hb on the fifth day after surgery , after correction for Hb transfused , was used to calculate the loss of Hb in grams . This value was then expressed as ml of blood loss . RESULTS The groups had similar characteristics . The median volume of drainage fluid after placebo was 845 ( interquartile range 523 - 990 ) ml and after tranexamic acid was 385 ( 331 - 586 ) ml ( P<0.001 ) . Placebo patients received 2 ( 0 - 2 ) units and tranexamic acid patients 0 ( 0 - 0 ) units of packed red cells ( P<0.001 ) . The estimated blood loss was 1426 ( 1135 - 1977 ) ml and 1045 ( 792 - 1292 ) ml , respectively ( P<0.001 ) . The hidden loss of blood ( calculated as loss minus drainage volume ) was 618 ( 330 - 1347 ) ml and 524 ( 330 - 9620 ) ml , respectively ( P=0.41 ) . Two patients in each group developed deep vein thrombosis . CONCLUSIONS Tranexamic acid decreased total blood loss by nearly 30 % , drainage volume by approximately 50 % and drastically reduced transfusion . However , concealed loss was only marginally influenced by tranexamic acid and was at least as large as the drainage volume Purpose The surgical stress of total knee arthroplasty ( TKA ) procedure and the application of intra-operative pneumatic thigh tourniquet increases local fibrinolytic activity , which contributes significantly to post-operative blood loss . Tranexamic acid , an antifibrinolytic drug , is commonly used to control post-operative blood loss . The recommended mode of administration of tranexamic acid is either oral or intravenous . However , the mechanism of action of the tranexamic acid points towards the possible effectiveness it may have following local/intra-articular application . This prospect i ve , double-blinded , r and omized preliminary study evaluated the efficacy of intra-articular tranexamic acid in reducing TKA-associated post-operative blood loss . Methods Fifty consenting patients with osteoarthritis of the knee scheduled for primary unilateral cemented-TKA were r and omly allocated to one of the two groups : Tranexamic Acid ( TA ) group ( n = 25 , 500 mg/5 ml tranexamic acid ) and the control group ( n = 25 , 5 ml 0.9 % saline ) . The drug and control solution were administered intra-articularly through the drain tube immediately after the wound closure . Parameters related to blood loss ( drop in haemoglobin , haematocrit differential ) and the drain output [ volume ( ml ) ] were compared between the two groups . Results On a comparative basis , TA-group obtained significant reduction in the drain output [ 95 % CI : 360.41–539.59 , p < 0.001 ] at 48 h post-operatively . Even though the control group received sixfold more blood transfusion than TA-group , it showed a greater drop in haemoglobin and haematocrit ( p < 0.05 ) . Conclusions Local application of tranexamic acid seems to be effective in reducing post-TKA blood loss as well as blood transfusion requirements . Level of evidence Therapeutic study , Level II After total knee arthroplasty ( TKA ) the technique of wound management is not st and ardised . In this prospect i ve study the efficacy of autologous blood reinfusion from the wound was investigated . One hundred patients ( 100 TKAs ) were enrolled in this sequential cohort study . In one-half of the operations , a reinfusion system with suction and in the other half one wound drain without suction were used . Blood loss , transfusion requirements , range of motion , Insall scores and the incidence of complications were studied . The use of a reinfusion system did not decrease the homologous transfusion requirements . The blood loss in the group with a suction drainage system was significantly higher . Our experiences since May 2002 with one drain without suction in 787 consecutive TKAs confirm all findings of the current study .RésuméAprès une arthroplastie totale du genou le problème des pertes sanguines , n’est pas aujourd’hui un problème st and ardisé . Lors d’une étude prospect i ve , l’efficacité de l’autotransfusion a été appréciée . Cent prothèses totales ont été enrôlées dans une cohorte . La moitié d’entre eux ont bénéficié d’une retransfusion des pertes sanguines du redon et pour l’autre moitié , le redon simple a été utilisé , sans récupération du sang post-opératoire . Les pertes de sang , la nécessité de transfusion , la mobilité , le score Insall et les complications ont été étudiés . L’utilisation d’une récupération avec retransfusion du sang post-opératoire ne diminue pas le nombre de transfusions homologues . Les pertes sanguines dans le groupe avec drainage simple sont plus importantes . Notre expérience depuis mai 2002 avec l’utilisation d’un drain sans aspiration dans 787 prothèses totales du genou consécutives confirment ses données Background The antifibrinolytic tranexamic acid reduces surgical blood loss , but studies have not identified an optimal regimen . Questions / purpose sWe studied different dosages , timings , and modes of administration to identify the most effective regimen of tranexamic acid in achieving maximum reduction of blood loss in TKA . Methods We prospect ively studied five regimens ( four intravenous , one local ; 40 patients each ) with a control group ( no tranexamic acid ) . The four intravenous ( 10-mg/kg dose ) regimens included ( 1 ) intraoperative dose ( IO ) given before tourniquet deflation , ( 2 ) additional preoperative dose ( POIO ) , ( 3 ) additional postoperative dose ( IOPO ) , and ( 4 ) all three doses ( POIOPO ) . The fifth regimen was a single local application ( LA ) . Two independent parameters of drain loss and total blood loss , calculated by the hemoglobin balance method , were evaluated statistically . Results Both parameters were reduced in all five regimens as against the control . A significant reduction in drain loss was seen in the POIO , IOPO , and POIOPO groups whereas total blood loss was significantly reduced in the POIO , POIOPO , and LA groups . The POIOPO group had the least drain loss ( 303 mL ) and least total blood loss ( 688 mL ) . The IO group had the greatest drain loss and the IOPO group the greatest total blood loss . Conclusions Single-dose tranexamic acid did not give effective results . The two-dose regimen of POIO was the least amount necessary for effective results . When compared against the control , this regimen produced reduction of drain loss and total blood loss , whereas the IOPO regimen did not . The three-dose regimen of POIOPO produced maximum effective reduction of drain loss and total blood loss . Level of Evidence Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence Abstract There have been several attempts to reduce postoperative blood loss in patients undergoing total arthroplasty . Benoni et al. reported the usefulness of tranexamic acid in total knee arthroplasty ( TKA ) . We investigated its effect in TKA and total hip arthroplasty ( THA ) . Blood loss was significantly reduced in patients given tranexamic acid in both the TKA and THA groups , and no severe complications , such as venous or pulmonary thrombosis , were noted in any of the patients who received the agent . Administration of tranexamic acid seems to be useful for reducing postoperative blood loss in TKA and THA UNLABELLED Both acute normovolemic hemodilution ( NVHD ) and tranexamic acid ( TA ) are potentially useful allogeneic blood conservation strategies after total knee replacement . However , the relative efficacy of these blood-sparing techniques is unknown . Therefore , to compare the postoperative allogeneic blood sparing of NVHD and TA after total knee replacement , we investigated 40 patients in a prospect i ve , single-blinded study protocol . In Group TA , 30 min before deflating the limb tourniquet , an IV infusion of TA , 15 mg/kg , was administered over a 30-min period . Thereafter , a constant IV infusion of 10 mg x kg(-1 ) x hr(-1 ) was administered until 12 h after deflation of the limb tourniquet . Before induction of anesthesia , NVHD patients were bled to a target hematocrit of approximately 28 % . Intravascular blood volume was maintained with lactated Ringer 's solution . All autologous blood was transfused at the end of the surgery . Postoperatively , hematocrit was measured daily . In all cases , a hematocrit < 27 % was the postoperative transfusion trigger . Before discharge , deep vein thrombosis was excluded by Echo Doppler . Three months after surgery , the incidence of delayed thromboembolic events was assessed . The two groups were demographically comparable . In Group NVHD , 843 mL+/-289 of autologous blood was removed . Despite autologous blood transfusion , during the early postoperative period and until the third postoperative day , the NVHD group had significantly ( P < 0.01 ) lower mean hematocrits when compared with the TA group . Thereafter , because of a significantly ( P < 0.0008 ) greater allogeneic blood requirement in the NVHD group , no statistically significant difference in mean hematocrit recordings was noted among the groups . Blood accumulation in the surgical drain 12 h postoperatively , was significantly ( P < 0.0008 ) higher in the NVHD group ( 259 mL+/-156 ) when compared with the TA group ( 110 mL+/-62 ) . Significantly ( P < 0.0008 ) more allogeneic blood was transfused in the NVHD group ( 19 U/13 patients ) when compared with the TA group ( 2 U/2 patients ) . No abnormal Echo Doppler studies were reported . During the 3-mo follow-up period , a deep vein thrombosis and pulmonary embolus were documented in one patient in the NVHD group . We conclude that perioperative hemodynamic stability and allogeneic blood sparing is superior after
Output:
| Results Both systemic and topical administrations reduced blood loss after TKA , but transfusion reducing effects varied in studies whether systemic or topical administrations .
The effects of TNA were influenced by doses and timings of administration .
No increased incidences of symptomatic DVT and PE were found for all reported doses , timings , and routes of TNA administration . |
MS210956 | ***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 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 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 : 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 physiotherapist for instruction at approximately 3 , 4 , 6 and 9 months postpartum . Results collected 12 months after delivery included prevalence and frequency of incontinence and PFME , sexual satisfaction , perineometry measurements and pad tests . Twenty-six ( 22 % ) of the control group and 59 ( 52 % ) of the intervention group withdrew before the final assessment . The prevalence of incontinence was significantly less in the intervention group than in the control group ( 50 % versus 76%,P=0.0003 ) , and this group also did significantly more PFME . There were no significant differences between the groups as regards sexual satisfaction , perineometry measurements or pad test results OBJECTIVE : To date , the evidence on pelvic floor injury in labor remains sketchy due to a lack of prospect i ve studies comparing pelvic floor imaging before and after childbirth . We intended to define the incidence of major trauma to the pubovisceral muscle . METHODS : A total of 61 nulliparous women were seen at 36–40 weeks of gestation in a prospect i ve observational study . The assessment included an interview and 3-dimensional translabial ultrasound and was repeated 2–6 months postpartum . RESULTS : Fifty women ( 82 % ) were seen postpartum . Of the 39 women delivered vaginally , levator avulsion was diagnosed in 14 ( 36 % , 95 % confidence interval 21–51 % ) . Among those delivered vaginally , there were associations with higher maternal age ( P = .10 ) , vaginal operative delivery ( P = .07 ) , and worsened stress incontinence postpartum ( P = .02 ) . CONCLUSIONS : Avulsion of the inferomedial aspects of the levator ani from the pelvic sidewall occurred in approximately one third of all women delivered vaginally and was associated with stress incontinence 3 months after childbirth . LEVEL OF EVIDENCE : OBJECTIVES This study was undertaken to estimate the association between pelvic floor muscle training and demographic and health related factors that may influence pelvic floor muscle training postpartum . STUDY DESIGN This analysis includes the first 17,978 women enrolled in the Norwegian Mother and Child Cohort Study who answered questions about pelvic floor muscle training ( n = 17,744 ) . We used logistic regression analyses , and the results are presented as crude and adjusted odds ratios with 95 % CI . RESULTS Women doing regular pelvic floor muscle training were more educated , likely to participate in general fitness activities , and had more children . Women experiencing urinary leakage and pelvic girdle pain postpartum were also more likely to do pelvic floor muscle training ( adjusted odds ratio = 1.26 , 95 % CI 1.18 - 1.35 ; adjusted odds ratio = 1.31 , 95 % CI 1.23 - 1.39 ) . Those who smoked daily or were delivered by cesarean were less likely to do pelvic floor muscle training ( adjusted odds ratio = 0.81 , 95 % CI 0.72 - 0.91 ; adjusted odds ratio = 0.56 , 95 % CI 0.51 - 0.61 ) . CONCLUSION There is a need for more research concerning effective strategies to enhance postpartum pelvic floor muscle training The process by which new therapies enter clinical practice is frequently suboptimal . Often , ideas for new therapies are generated by clinical observations or laboratory studies ; therapies based on those ideas may enter clinical practice without any further scrutiny . As a consequence , some ineffective practice s become widespread . This article proposes a six-stage protocol for the implementation of new therapies . Hypotheses about therapy based on pre clinical research should be subject to clinical exploration and pilot studies prior to rigorous assessment with r and omised clinical trials . If r and omised clinical trials suggest that the intervention produces clinical ly important effects , further r and omised studies can be conducted to refine the intervention . New interventions should not be recommended , or included in teaching curricula , or taught in continuing education courses until their effectiveness has been demonstrated in high- quality r and omised clinical trials OBJECTIVE Urinary incontinence is a chronic health complaint that severely reduces quality of life . Pregnancy and vaginal delivery are main risk factors in the development of urinary incontinence . The aim of this study was to assess whether intensive pelvic floor muscle training during pregnancy could prevent urinary incontinence . METHODS We conducted a single-blind r and omized controlled trial at Trondheim University Hospital and three outpatient physiotherapy clinics in a primary care setting . Three hundred one healthy nulliparous women were r and omly allocated to a training ( n = 148 ) or a control group ( n = 153 ) . The training group attended a 12-week intensive pelvic floor muscle training program during pregnancy , supervised by physiotherapists . The control group received the customary information . The primary outcome measure was self-reported symptoms of urinary incontinence . The secondary outcome measure was pelvic floor muscle strength . RESULTS At follow-up , significantly fewer women in the training group reported urinary incontinence : 48 of 148 ( 32 % ) versus 74 of 153 ( 48 % ) at 36 weeks ' pregnancy ( P = .007 ) and 29 of 148 ( 20 % ) versus 49 of 153 ( 32 % ) 3 months after delivery ( P = .018 ) . According to numbers needed to treat , intensive pelvic floor muscle training during pregnancy prevented urinary incontinence in about one in six women during pregnancy and one in eight women after delivery . Pelvic floor muscle strength was significantly higher in the training group at 36 weeks ' pregnancy ( P = .008 ) and 3 months after delivery ( P = .048 ) . CONCLUSION Intensive pelvic floor muscle training during pregnancy prevents urinary incontinence during pregnancy and after delivery . Pelvic floor muscle strength improved significantly after intensive pelvic floor muscle training Abstract Objectives : To assess the effect of nurse assessment with reinforcement of pelvic floor muscle training exercises and bladder training compared with st and ard management among women with persistent incontinence three months postnatally . Design : R and omised controlled trial with nine months ' follow up . Setting : Community intervention in three centres ( Dunedin , New Zeal and ; Birmingham ; Aberdeen ) . Participants : 747 women with urinary incontinence three months postnatally , allocated at r and om to intervention ( 371 ) or control ( 376 ) groups . Intervention : Assessment by nurses of urinary incontinence with conservative advice on pelvic floor exercises at five , seven , and nine months after delivery supplemented with bladder training if appropriate at seven and nine months . Main outcome measures : Primary : persistence and severity of urinary incontinence 12 months after delivery . Secondary : performance of pelvic floor exercises , change in coexisting faecal incontinence , wellbeing , anxiety , and depression . Results : Women in the intervention group had significantly less urinary incontinence : 167/279 ( 59.9 % ) v 169/245 ( 69.0 % ) , difference 9.1 % ( 95 % confidence interval 1.0 % to 17.3 % , P=0.037 ) for any incontinence and 55/279 ( 19.7 % ) v 78/245 ( 31.8 % ) , difference 12.1 % ( 4.7 % to 19.6 % , P=0.002 ) for severe incontinence . Faecal incontinence was also less common : 12/273 ( 4.4 % ) v 25/237 ( 10.5 % ) , difference 6.1 % ( 1.6 % to 10.8 % , P=0.012 ) . At 12 months women in the intervention group were more likely to be performing pelvic floor exercises ( 218/278 ( 79 % ) v 118/244 ( 48 % ) , P<0.001 ) . Conclusions : A third of women may have some urinary incontinence three months after childbirth . Conservative management provided by nurses seems to reduce the likelihood of urinary and coexisting faecal incontinence persisting 12 months postpartum . Further trials for faecal incontinence are needed . What is already known on this topic Vaginal delivery is a risk factor for urinary incontinence Three months after childbirth 20 - 30 % of women still experience urinary incontinence Most women do not seek treatment What this study adds Women will use conservative treatments such as pelvic floor
Output:
| Based on the studies with relevant sample size , high adherence to a strength-training protocol and close follow-up , we found that PFMT during pregnancy and after delivery can prevent and treat UI .
A supervised training protocol following strength-training principles , emphasising close to maximum contractions and lasting at least 8 weeks is recommended .
PFMT is effective when supervised training is conducted . |
MS210957 | ***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 Enzalutamide ( formerly called MDV3100 ) targets multiple steps in the and rogen-receptor-signaling pathway , the major driver of prostate-cancer growth . We aim ed to evaluate whether enzalutamide prolongs survival in men with castration-resistant prostate cancer after chemotherapy . METHODS In our phase 3 , double-blind , placebo-controlled trial , we stratified 1199 men with castration-resistant prostate cancer after chemotherapy according to the Eastern Cooperative Oncology Group performance-status score and pain intensity . We r and omly assigned them , in a 2:1 ratio , to receive oral enzalutamide at a dose of 160 mg per day ( 800 patients ) or placebo ( 399 patients ) . The primary end point was overall survival . RESULTS The study was stopped after a planned interim analysis at the time of 520 deaths . The median overall survival was 18.4 months ( 95 % confidence interval [ CI ] , 17.3 to not yet reached ) in the enzalutamide group versus 13.6 months ( 95 % CI , 11.3 to 15.8 ) in the placebo group ( hazard ratio for death in the enzalutamide group , 0.63 ; 95 % CI , 0.53 to 0.75 ; P<0.001 ) . The superiority of enzalutamide over placebo was shown with respect to all secondary end points : the proportion of patients with a reduction in the prostate-specific antigen ( PSA ) level by 50 % or more ( 54 % vs. 2 % , P<0.001 ) , the soft-tissue response rate ( 29 % vs. 4 % , P<0.001 ) , the quality -of-life response rate ( 43 % vs. 18 % , P<0.001 ) , the time to PSA progression ( 8.3 vs. 3.0 months ; hazard ratio , 0.25 ; P<0.001 ) , radiographic progression-free survival ( 8.3 vs. 2.9 months ; hazard ratio , 0.40 ; P<0.001 ) , and the time to the first skeletal-related event ( 16.7 vs. 13.3 months ; hazard ratio , 0.69 ; P<0.001 ) . Rates of fatigue , diarrhea , and hot flashes were higher in the enzalutamide group . Seizures were reported in five patients ( 0.6 % ) receiving enzalutamide . CONCLUSIONS Enzalutamide significantly prolonged the survival of men with metastatic castration-resistant prostate cancer after chemotherapy . ( Funded by Medivation and Astellas Pharma Global Development ; AFFIRM Clinical Trials.gov number , NCT00974311 . ) BACKGROUND Mitoxantrone-based chemotherapy palliates pain without extending survival in men with progressive and rogen-independent prostate cancer . We compared docetaxel plus estramustine with mitoxantrone plus prednisone in men with metastatic , hormone-independent prostate cancer . METHODS We r and omly assigned 770 men to one of two treatments , each given in 21-day cycles : 280 mg of estramustine three times daily on days 1 through 5 , 60 mg of docetaxel per square meter of body-surface area on day 2 , and 60 mg of dexamethasone in three divided doses before docetaxel , or 12 mg of mitoxantrone per square meter on day 1 plus 5 mg of prednisone twice daily . The primary end point was overall survival ; secondary end points were progression-free survival , objective response rates , and post-treatment declines of at least 50 percent in serum prostate-specific antigen ( PSA ) levels . RESULTS Of 674 eligible patients , 338 were assigned to receive docetaxel and estramustine and 336 to receive mitoxantrone and prednisone . In an intention-to-treat analysis , the median overall survival was longer in the group given docetaxel and estramustine than in the group given mitoxantrone and prednisone ( 17.5 months vs. 15.6 months , P=0.02 by the log-rank test ) , and the corresponding hazard ratio for death was 0.80 ( 95 percent confidence interval , 0.67 to 0.97 ) . The median time to progression was 6.3 months in the group given docetaxel and estramustine and 3.2 months in the group given mitoxantrone and prednisone ( P<0.001 by the log-rank test ) . PSA declines of at least 50 percent occurred in 50 percent and 27 percent of patients , respectively ( P<0.001 ) , and objective tumor responses were observed in 17 percent and 11 percent of patients with bidimensionally measurable disease , respectively ( P=0.30 ) . Grade 3 or 4 neutropenic fevers ( P=0.01 ) , nausea and vomiting ( P<0.001 ) , and cardiovascular events ( P=0.001 ) were more common among patients receiving docetaxel and estramustine than among those receiving mitoxantrone and prednisone . Pain relief was similar in both groups . CONCLUSIONS The improvement in median survival of nearly two months with docetaxel and estramustine , as compared with mitoxantrone and prednisone , provides support for this approach in men with metastatic , and rogen-independent prostate cancer BACKGROUND Abiraterone acetate ( AA ) is an and rogen bio synthesis inhibitor shown to prolong life in patients with castration-resistant prostate cancer ( CRPC ) already treated with chemotherapy . AA treatment results in dramatic declines in prostate-specific antigen ( PSA ) in some patients and no declines in others , suggesting the presence of molecular determinants of sensitivity in tumors . OBJECTIVE To study the role of transmembrane protease , serine 2 (TMPRSS2)-v-ets erythroblastosis virus E26 oncogene homolog ( ERG ) fusion , an and rogen-dependent growth factor , in circulating tumor cells ( CTCs ) as a biomarker of sensitivity to AA . DESIGN , SETTING , AND PARTICIPANTS The predictive value of TMPRSS2-ERG status was studied in 41 of 48 men with postchemotherapy-treated CRPC enrolled in sequential phase 2 AA trials . INTERVENTION Patients received AA 1000 mg daily and continuously . MEASUREMENTS TMPRSS2-ERG status was characterized by a sensitive , analytically valid reverse transcription polymerase chain reaction assay in CTCs enriched from ethylene-diaminetetraacetic acid anticoagulated blood obtained prior to AA treatment . Outcomes were measured by PSA Working Group 1 criteria . RESULTS AND LIMITATIONS St and ard procedures for specimen acquisition , processing , and testing using the vali date d TMPRSS2-ERG assay on a multiplex platform gave intra-assay and interassay coefficients of variation < 7 % . TMPRSS2-ERG fusion was present in 15 of 41 patients ( 37 % ) , who had a median baseline CTC count of 17 ( interquartile range : 7 - 103 cells per 7.5 ml ) . A PSA decline ≥50 % was observed in 7 of 15 patients ( 47 % ) with the fusion and in 10 of 26 patients ( 38 % ) without the fusion . Although limited by the low number of patients , a posttherapy CTC count of less than five per 7.5 ml was prognostic for longer survival relative to a CTC count five or more . TMPRSS2-ERG status did not predict a decline in PSA or other clinical outcomes . CONCLUSIONS Molecular profiles of CTCs with an analytically valid assay identified the presence of the prostate cancer-specific TMPRSS2-ERG fusion but did not predict for response to AA treatment . This finding demonstrates the role of CTCs as surrogate tissue that can be obtained in a routine practice setting . TRIAL REGISTRATION Clinical Trials.gov : NCT00474383 ( COU-AA-003 ) , NCT00485303 ( COU-AA-004 ) Background Treatment response biomarkers are urgently needed for castration-resistant prostate cancer ( CRPC ) . Baseline and post-treatment circulating tumor cell ( CTC ) counts of ≥5 cells/7.5 ml are associated with poor CRPC outcome . Objective To determine the value of a ≥30 % CTC decline as a treatment response indicator . Design , setting , and participants We identified patients with a baseline CTC count ≥5 cells/7.5 ml and evaluable post-treatment CTC counts in two prospect i ve trials . Intervention Patients were treated in the COU-AA-301 ( abiraterone after chemotherapy ) and IMMC-38 ( chemotherapy ) trials . Outcome measures and statistical analysis The association between a ≥30 % CTC decline after treatment and survival was evaluated using univariable and multivariable Cox regression models at three l and mark time points ( 4 , 8 , and 12 wk ) . Model performance was evaluated by calculating the area under the receiver operating characteristic curve ( AUC ) and c-indices . Results Overall 486 patients ( 122 in IMMC-38 and 364 in COU-AA-301 ) had a CTC count ≥5 cells/7.5 ml at baseline , with 440 , 380 , and 351 patients evaluable at 4 , 8 , and 12 wk , respectively . A 30 % CTC decline was associated with increased survival at 4 wk ( hazard ratio [ HR ] 0.45 , 95 % confidence interval [ CI ] 0.36–0.56 ; p < 0.001 ) , 8 wk ( HR 0.41 , 95 % CI 0.33–0.53 ; p < 0.001 ) , and 12 wk ( HR 0.39 , 95 % CI 0.3–0.5 ; p < 0.001 ) in univariable and multivariable analyses . Stable CTC count ( < 30 % fall or < 30 % increase ) was not associated with a survival benefit when compared with increased CTC count . The association between a 30 % CTC decline after treatment and survival was independent of baseline CTC count . CTC declines significantly improved the AUC at all time-points . Finally , in the COU-AA-301 trial , patients with CTC ≥5 cells/7.5 ml and a 30 % CTC decline had similar overall survival in both arms . Conclusions A 30 % CTC decline after treatment from an initial count ≥5 cells/7.5 ml is independently associated with CRPC overall survival following abiraterone and chemotherapy , improving the performance of a multivariable model as early as 4 wk after treatment . This potential surrogate must now be prospect ively evaluated . Patient summary Circulating tumor cells ( CTCs ) are cancer cells that can be detected in the blood of prostate cancer patients . We analyzed changes in CTCs after treatment with abiraterone and chemotherapy in two large clinical trials , and found that patients who have a decline in CTC count have a better survival outcome BACKGROUND And rogen receptor splice variant 7 ( AR-V7 ) in circulating tumor cells ( CTCs ) from patients with metastatic castration-resistant prostate cancer ( mCRPC ) was recently demonstrated to be associated with resistance to abiraterone and enzalutamide . Cabazitaxel might , however , remain effective in AR-V7-positive patients . OBJECTIVE To investigate the association between AR-V7 expression in CTCs and resistance to cabazitaxel . DESIGN , SETTING , AND PARTICIPANTS We selected patients with mCRPC from the multicenter , r and omized , phase 2 , r and omized , open-label , multicenter study in mCRPC on the pharmacodynamic effects of budesonide on cabazitaxel ( Jevtana ) ( CABARESC ) . Before the start of the first and third cabazitaxel cycle , CTCs were enumerated using the Cell Search System . In patients with ≥10 CTCs in 7.5 ml blood at baseline , the expression of AR-V7 was assessed by quantitative polymerase chain reaction . OUTCOME MEASURES AND STATISTICAL ANALYSIS The primary end point was the association between the AR-V7 status and the CTC response rate ( decrease to fewer than five CTCs in 7.5 ml blood during treatment ) . Secondary end points were the prostate-specific antigen ( PSA ) response rate ( RR ) and overall survival ( OS ) . Analyses were performed using chi-square and log-rank tests . RESULTS AND LIMITATIONS AR-V7 was detected in 16 of 29 patients ( 55 % ) with ≥10 CTCs and was more frequently found in abiraterone pretreated patients ( 5 of 5 [ 100 % ] treated vs 7 of 20 [ 35 % ] untreated ; p=0.009 ) . We found no differences in CTC and PSA RRs . The presence of AR-V7 in CTCs was not associated with progression-free survival ( hazard ratio [ HR ] : 0.8 ; 95 % confidence interval [ CI ] , 0.4 - 1.8 ) or overall survival ( HR 1
Output:
| EVIDENCE SYNTHESIS Nomograms of prognostic factors ( eg , albumin , lactate dehydrogenase ) enable clinicians to estimate the prognosis of men with mCRPC .
Determination of AR-V7 in CTCs is a big step towards a more personalized treatment approach in mCRPC .
Genomic characterization of liquid biopsies such as CTCs , cfDNA , and circulating RNA are noninvasive tools to further personalize treatment in prostate cancer .
Only by conducting biomarker-driven studies , rather than large one-size-fits-all trials , will we be able to improve prostate cancer treatment . |
MS210958 | ***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: Three intermediary base material s , a zinc oxide-eugenol ( Cavitec ) and two calcium hydroxide liners ( Life and Dycal ) , were selected at r and om for use as a base beneath amalgam or composite restorations on humans following complete caries removal . Life and Dycal , selected at r and om , were also used as direct and indirect pulp capping agents as clinical ly indicated . Clinical evaluations of signs and symptoms were made before treatment and at one-week , six-month , and one-year intervals following treatment . Histological evaluations were performed on three complete caries removal teeth and 18 direct pulp capping teeth six months following treatment . No significant differences in clinical symptomatology result ed between the material s in the complete caries removal group or the indirect and direct pulp capping groups Objectives Root canal therapy ( RCT ) and tooth extraction have been conventional treatment options for management of human mature teeth with irreversible pulpitis . Excellent short-term treatment outcomes of vital pulp therapy with calcium-enriched mixture cement ( VPT/CEM ) , as a new treatment option , on postoperative pain relief was demonstrated ; if intermediate- and long-term treatment outcomes of the new treatment are also non-inferior compared to RCT , then VPT/CEM may become a viable treatment option for management of mature teeth with irreversible pulpitis . Material s and methods In 23 healthcare centers , 407 9- to 65-year-old patients were r and omly allocated into two study arms including one-visit RCT ( reference treatment ; n = 202 ) and VPT/CEM ( alternative treatment ; n = 205 ) . Six- and twelve-month clinical and radiographic successes were assessed . Results Mean follow-up times at 6- and 12-month follow-ups were “ 6.70 ± 0.68 and 6.72 ± 0.71 months ” and “ 12.96 ± 0.67 and 12.90 ± 0.66 months ” in the available cases of RCT and VPT/CEM arms , respectively . Favorable clinical success rates in the two study arms did not show statistical difference ; however , the radiographic success rate in the VPT/CEM was significantly greater than RCT arm at the two follow-ups ( P < 0.001 ) . The patients ’ age had no effect on the treatment outcomes ( P = 0.231 ) . Conclusions Treatment outcomes of VPT/CEM may be superior to RCT in mature molars with irreversible pulpitis . The performance of bio material s such CEM cement may assist in the shift towards more biologic treatments . Clinical relevance VPT/CEM may be a realistic alternative treatment for human mature molar teeth with symptoms of irreversible pulpitis ; the use of VPT/CEM is highly beneficial for patients as well as general dentists In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias Aim : This r and omized , multicenter clinical trial by Maltz et al. [ 1 ] evaluated the effectiveness of two treatments for deep caries lesions — partial caries removal ( PCR ) and stepwise excavation (SW)—with respect to the primary outcome of pulp vitality for a 3-year follow-up period . Material and methods : Inclusion criteria were as follows : patients with permanent molars presenting deep caries lesions ( lesion affecting ≥1/2 of the dentin on radiographic examina tion ) , positive response to a cold test , absence of spontaneous pain , negative sensitivity to percussion , and absence of periapical lesions ( radiographic examination ) . Teeth r and omly assigned to PCR ( test ) received incomplete caries removal and filling in a single session . Outcome success was evaluated by assessment of pulp vitality , determined by pulp sensitivity to a cold test and the absence of periapical lesions . Data were analyzed by a Weibull regression model with shared frailty term ( survival analysis ) . Results : At baseline , 299 treatments were executed : PCR 152 and SW 147 . By the end of the 3-year follow-up period , 213 teeth had been evaluated . Adjusted survival rates were 91 % for PCR and 69 % for SW ( p=0.004 ) . Conclusion : These results suggest that there is no need to reopen a cavity and perform a second excavation for pulp vitality to be preserved ( Clinical trials registration NCT00887952 ) . Conflict of interest The corresponding author states that there are no conflicts of interest . Ziel : Diese r and omisierte , multizentrische klinische Studie untersuchte die Effektivitat von zwei Therapieansatzen zur Beh and lung tiefer karioser Lasionen : partielle Kariesentfernung ( PCR ) und mehrstufige Exkavation ( SW ) . Die primar zu untersuchende Auswirkung war die Vitalitat uber 3 Jahre . Material und Method e : Einschlusskriterien waren : Patienten deren permanente Molaren tiefe kariose Lasionen aufweisen ( rontgenologische Lasionen ≥½ des Dentins ) , positive Reak tion auf Kalte , Ausbleiben von Spontanschmerzen , negative Sensitivitat auf Perkussion , radiologisch keine apikalen Lasionen . Bei Zahnen , die in die PCR-Gruppe ( Test ) r and omisiert wurden , erfolgten eine unvollst and ige Kariesentfernung und die Fullung in einer Sitzung . I m Anschluss wurden die Vitalitat , das Ansprechen auf einen Kaltetest und das Ausbleiben von periapikalen Lasionen ermittelt . Die Auswertung erfolgte uber ein Weibull Regressionsmodell mit einem " shared frailty term " ( Lebensdaueranalyse ) Less invasive excavation methods have been suggested for deep caries lesions . We tested the effects of stepwise vs. direct complete excavation , 1 yr after the procedure had been carried out , in 314 adults ( from six centres ) who had received treatment of a tooth with deep caries . The teeth had caries lesions involving 75 % or more of the dentin and were central ly r and omized to stepwise or direct complete excavation . Stepwise excavation result ed in fewer pulp exposures compared with direct complete excavation [ difference : 11.4 % , 95 % confidence interval ( CI ) ( 1.2 ; 21.3 ) ] . At 1 yr of follow-up , there was a statistically significantly higher success rate with stepwise excavation , with success being defined as an unexposed pulp with sustained pulp vitality without apical radiolucency [ difference : 11.7 % , 95 % CI ( 0.5 ; 22.5 ) ] . In a subsequent nested trial , 58 patients with exposed pulps were r and omized to direct capping or partial pulpotomy . We found no significant difference in pulp vitality without apical radiolucency between the two capping procedures after more than 1 yr [ 31.8 % and 34.5 % ; difference : 2.7 % , 95 % CI ( -22.7 ; 26.6 ) ] . In conclusion , stepwise excavation decreases the risk of pulp exposure compared with direct complete excavation . In view of the poor prognosis of vital pulp treatment , a stepwise excavation approach for managing deep caries lesions is recommended OBJECTIVE The purpose of this project was to evaluate the performance of a dentin adhesive system on carious and noncarious primary dentin in vivo . METHOD AND MATERIAL S Forty-eight primary molars with carious lesions were r and omly assigned to 2 different treatments : group 1 ( control , n = 24)--All identifiable , irreversibly infected dentin was removed prior to the application of the bonding agent and restorative material ; group 2 ( experimental , n = 24)--Irreversibly infected dentin was partially removed prior to the application of the bonding agent and restorative material . The control and experimental teeth were clinical ly monitored every 3 months and evaluated 12 months after restoration . The teeth were extracted around the time of exfoliation and processed for scanning electron microscopy . RESULTS Retention rate , marginal integrity , and pulpal symptoms were identical in both groups . Radiographically , the radiolucent area associated with the experimental restorations did not increase with time in 75 % of the cases . For the control group , the adhesive system formed a hybrid layer . In the experimental group , there was morphologic evidence of the formation of an acid-resistant " altered hybrid layer . " An acid-resistant tissue , result ing from the interdiffusion of adhesive resin within the area of carious dentin , was observed adjacent to and under the altered hybrid layer . CONCLUSION Application of an adhesive restorative system to irreversibly infected dentin did not affect the clinical performance of the restoration PURPOSE The purpose of this prospect i ve and r and omized in vivo study was to compare the clinical and radiographic outcomes of an adhesive resin system vs a calcium hydroxide liner for protection of the dentin-pulp complex of primary molars treated with indirect pulp treatment . METHODS Forty-eight primary molars with deep occlusal caries , but without preoperative signs and symptoms of irreversible pulpitis , received indirect pulp treatment and were restored with a composite resin ( Z100 ) . The teeth were r and omly divided into 2 groups according to the material used for protection of the dentin-pulp complex : ( 1 ) adhesive resin system ( Scotchbond Multi Purpose ) ; and ( 2 ) calcium hydroxide liner ( Dycal ) . These teeth were evaluated clinical ly and radiographicaly for 2 years . RESULTS After 2 years , 83 % ( 19/23 ) of the teeth treated with calcium hydroxide and 96 % ( 24/25 ) of teeth treated with only the adhesive resin system presented a successful outcome , as determined by clinical and radiographic examination . Interradicular and /or periapical lesions were the most predominant signs of treatment failure , since 3 out of 23 teeth treated with calcium hydroxide and 1 out of 25 teeth treated with only adhesive resin presented this outcome . One tooth treated with the calcium hydroxide liner was diagnosed with internal root resorption at the 18-month examination . Of the 5 teeth diagnosed from radiographs as a failure of the indirect pulp treatment , none presented clinical signs/symptoms of pulpitis or necrosis such as the presence of fistula , enhanced tooth mobility , or pain . CONCLUSIONS This study demonstrates that protection of the dentin-pulp complex of primary molars with an adhesive resin system results in similar clinical and radiographic 2-year outcomes as compared to calcium hydroxide when indirect pulp treatment is performed in Class I composite restorations Aim : To prospect ively compare the clinical success rate of partial pulpotomy treatment in permanent molars using calcium hydroxide ( CH ) and mineral trioxide aggregates ( MTA ) as pulp dressing agents . Methods : Restorable permanent first molars ( 64 ) with carious pulp exposures were r and omly assigned to two groups ; CH and MTA . A st and ardized operative procedure was followed in both groups . Following isolation and caries removal , the exposed superficial pulp tissue layers were removed with a sterile flame shape diamond bur to a depth of 2–4 mm . Bleeding was controlled and pulp dressed with either a paste of non- setting Ca(OH)2 followed by a setting layer of Ca(OH)2 , or with grey MTA . The dressing material s in both groups were then covered with a layer of light cured glass ionomer cement . The teeth were either restored using amalgam , or where grossly carious with preformed metal crowns . Patients were scheduled for follow-up at 3 , 6 , 12 months and annually thereafter . Results : There were 34 patients ( 17 males and 17 females ) with 51 teeth available for evaluation . The age of patients at the time of restoration ranged between 6.8 to 13.3 years ( mean of 10.3 ±1.8 years ) . The follow-up period ranged from 25.4 to 45.6 months with an average of 34.8 ± 4.4 months . There was no statistically significant difference in the success rate of teeth treated with CH ( 91 % ) in comparison to teeth treated with MTA ( 93 % ) . Radiographically , a hard tissue barrier under CH was noticed in 12 ( 55 % ) teeth compared with 18 ( 64 % ) teeth under MTA ( p=0.4 ) . Conclusions : MTA has clinical success rate comparable to CH as a pulp dressing material for partial pulpotomy in permanent molars with carious The aim was to assess the prevalence of pulp exposure after stepwise versus direct complete excavation of permanent posterior teeth with deep carious lesions . The material , representing 116 patients aged 6 - 16 yrs ( mean = 10.2 yrs ) , consisted of 1
Output:
| The overall evidence was insufficient to assess which of indirect pulp capping , stepwise excavation , direct excavation and pulp capping/partial pulpotomy , pulpotomy or pulpectomy is the most effective treatment approach for teeth with deep caries .
CONCLUSIONS Because of the lack of good studies it is not possible to determine whether an injured pulp by deep caries can be maintained or whether it should be removed and replaced with a root canal filling . |
MS210959 | ***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 Economic evaluations provide an important basis for allocation of re sources and health services planning . The aim of this study was to evaluate and compare the costs of correcting anterior crossbite with functional shift , using fixed or removable appliances ( FA or RA ) and to relate the costs to the effects , using cost-minimization analysis . DESIGN , SETTING , AND PARTICIPANTS Sixty-two patients with anterior crossbite and functional shift were r and omized in blocks of 10 . Thirty-one patients were r and omized to be treated with brackets and arch wire ( FA ) and 31 with an acrylic plate ( RA ) . Duration of treatment and number and estimated length of appointments and cancellations were registered . Direct costs ( premises , staff salaries , material , and laboratory costs ) and indirect costs ( the accompanying parents ' loss of income while absent from work ) were calculated and evaluated with reference to successful outcome alone , to successful and unsuccessful outcomes and to re-treatment when required . Societal costs were defined as the sum of direct and indirect costs . INTERVENTIONS Treatment with FA or RA . RESULTS There were no significant differences between FA and RA with respect to direct costs for treatment time , but both indirect costs and direct costs for material were significantly lower for FA . The total societal costs were lower for FA than for RA . LIMITATIONS Costs depend on local factors and should not be directly extrapolated to other locations . CONCLUSION The analysis disclosed significant economic benefits for FA over RA . Even when only successful outcomes were assessed , treatment with RA was more expensive . TRIAL REGISTRATION This trial was not registered . PROTOCOL The protocol was not published before trial commencement OBJECTIVES The Access to Baby and Child Dentistry ( ABCD ) Program addresses the needs of families in obtaining dental care . In this study , the program was evaluated in rural Stevens County , Washington . Aims were to assess utilization of dental services , average dental expenditures per child , and oral health status . METHODS Medicaid-enrolled children aged 1 - 4 years were r and omly assigned to the ABCD program ( n=216 ) or to regular benefits ( n=221 ) . An outreach worker contacted each ABCD family and provided an orientation . Dental care utilization and expenditures were calculated from cl aims . A posttest-only design was used to evaluate oral health status . RESULTS An enrollment effect was seen in ABCD , but the difference between groups was not sustained . There was a doubling of utilization between groups for the youngest cohort , while the others showed no differences . In the first year the rate was higher for the entire ABCD group than for the children not in ABCD ( 34.0 % vs 24.7 % ) . Thirty-three percent of ABCD children ( 70/212 ) who had visited the dentist had > 1 appointment compared to 21.5 percent ( 47/219 ) for the children not in ABCD who had visited the dentist . There was no overall difference in expenditures , while expenditures for preventive services were greater for ABCD . ABCD children had fewer teeth with initial caries . The average incremental cost per child per initial lesion prevented was 31.44 dollars . CONCLUSION ABCD most benefited the youngest cohort of children and improved health OBJECTIVE A growing number of studies have investigated the prevalence of Molar Incisor Hypomineralization ( MIH ) around the world . The aim of this study was to systematic ally estimate the pooled prevalence of MIH . METHODS A comprehensive literature research was completed in English and Chinese data bases . R and om effect models were used to calculate the pooled prevalence . To address the heterogeneity , meta-regression , and sensitivity analyzes were conducted . Publication bias was estimated by trim and fill method . RESULTS Seventy eligible studies were included . The pooled prevalence of MIH was 14.2 % globally . In subgroup analysis , South America ( 18.0 % , 95 % CI : 13.8 - 22.2 ) and Spain ( 21.1 % , 95 % CI : 17.7 - 24.6 ) had the highest prevalence . There was no significant difference between males ( 14.3 % , 95 % CI : 12.0 - 16.6 ) and females ( 14.4 % , 95 % CI : 12.8 - 15.9 ) . The prevalence of MIH among children 10 years of age or younger ( 15.1 % , 95 % CI : 12.1 - 18.2 ) was much higher than the prevalence of MIH among older children ( 12.1 % , 95 % CI : 8.0 - 16.3 ) . Sample size explained 15.7 % heterogeneity . CONCLUSION MIH has a high incidence globally , especially among children < 10 years old . It is , therefore , imperative to develop more appropriate dental healthcare strategies to care for these children and to identify the etiology of MIH to prevent it occurring BACKGROUND Dental caries is the most common disease of childhood . The NHS guidelines promote preventative care in dental practice s , particularly for young children . However , the cost-effectiveness of this policy has not been established . OBJECTIVE To measure the effects and costs of a composite fluoride intervention design ed to prevent caries in young children attending dental services . DESIGN The study was a two-arm , parallel-group , r and omised controlled trial , with an allocation ratio of 1 : 1 . R and omisation was by clinical trials unit , using r and omised permuted blocks . Children/families were not blinded ; however , outcome assessment was blinded to group assessment . SETTING The study took place in 22 NHS dental practice s in Northern Irel and , UK . PARTICIPANTS The study participants were children aged 2 - 3 years , who were caries free at baseline . INTERVENTIONS The intervention was composite in nature , comprising a varnish containing 22,600 parts per million ( p.p.m . ) fluoride , a toothbrush and a 50-ml tube of toothpaste containing 1450 p.p.m . fluoride ; plus st and ardised , evidence -based prevention advice provided at 6-monthly intervals over 3 years . The control group received the prevention advice alone . MAIN OUTCOME MEASURES The primary outcome measure was conversion from caries-free to caries-active states . Secondary outcome measures were the number of decayed , missing or filled tooth surfaces in primary dentition ( dmfs ) in caries-active children , the number of episodes of pain , the number of extracted teeth and the costs of care . Adverse reactions ( ARs ) were recorded . RESULTS A total of 1248 children ( 624 r and omised to each group ) were recruited and 1096 ( 549 in the intervention group and 547 in the control group ) were included in the final analyses . A total of 87 % of the intervention children and 85 % of control children attended every 6-month visit ( p = 0.77 ) . In total , 187 ( 34 % ) children in the intervention group converted to caries active , compared with 213 ( 39 % ) in the control group [ odds ratio ( OR ) 0.81 , 95 % confidence interval ( CI ) 0.64 to 1.04 ; p = 0.11 ] . The mean number of tooth surfaces affected by caries was 7.2 in the intervention group , compared with 9.6 in the control group ( p = 0.007 ) . There was no significant difference in the number of episodes of pain between groups ( p = 0.81 ) . However , 164 out of the total of 400 ( 41 % ) children who converted to caries active reported toothache , compared with 62 out of 696 ( 9 % ) caries-free children ( OR 7.1 95 % CI 5.1 to 9.9 ; p < 0.001 ) . There was no statistically significant difference in the number of teeth extracted in caries-active children ( p = 0.95 ) . Ten children in the intervention group had ARs of a minor nature . The average direct dental care cost was £ 155.74 for the intervention group and £ 48.21 for the control group over 3 years ( p < 0.05 ) . The mean cost per carious surface avoided over the 3 years was estimated at £ 251.00 . LIMITATIONS The usual limitations of a trial such as generalisability and underst and ing the underlying reasons for the outcomes apply . There is no mean willingness-to-pay threshold available to enable assessment of value for money . CONCLUSIONS A statistically significant effect could not be demonstrated for the primary outcome . Once caries develop , pain is likely . There was a statistically significant difference in dmfs in caries-active children in favour of the intervention . Although adequately powered , the effect size of the intervention was small and of question able clinical and economic benefit . FUTURE WORK Future work should assess the caries prevention effects of interventions to reduce sugar consumption at the population and individual levels . Interventions design ed to arrest the disease once it is established need to be developed and tested in practice . TRIAL REGISTRATION Current Controlled Trials IS RCT N36180119 and EudraCT 2009 - 010725 - 39 . FUNDING This project was funded by the National Institute for Health Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 20 , No. 71 . See the NIHR Journals Library website for further project information The aim of this study was to assess the cost-effectiveness of an experimental caries-control regimen in a r and omized clinical trial ( RCT ) conducted in Pori , Finl and , in 2001 - 2005 . Children ( n = 497 ) who were 11 - 12 yr of age and had at least one active initial caries lesion at baseline were studied . The children in the experimental group ( n = 250 ) were offered an individually design ed patient-centered regimen for caries control . The children in the control group ( n = 247 ) received st and ard dental care . Furthermore , the whole population was exposed to continuous community-level oral health promotion . Individual costs of treatment procedures and outcomes ( DMFS increment score ) for the follow-up period of 3.4 yr were calculated for each child in both groups . The incremental cost-effectiveness ratio was euro 34.07 per averted DMF surface . The experimental regimen was more effective , and also more costly . However , the total costs decreased year after year , and for the last 2 yr the experimental regimen was less expensive than the st and ard dental care . The experimental regimen would probably have been more cost-effective than st and ard dental care if the follow-up period had been longer , the regimen less comprehensive , and /or if dental nurses had conducted the preventive procedures OBJECTIVE Paediatric dental care under general anaesthesia among preschool children in Western Australia is increasing and costly . This study assessed cost-effectiveness of the atraumatic restorative treatment-based ( ART-based ) approach against the st and ard care ( SC ) approach to managing early childhood caries in a primary care setting based on a 1-year pragmatic r and omized controlled trial . METHODS Cost-effectiveness analysis , from the service provider perspective , was conducted . Outcomes include number of referral to specialists and dental treatments . One-way and probabilistic sensitivity analyses were undertaken to test the robustness of the cost-effectiveness estimates . RESULTS Six children in the ART-based group and 62 children in the SC group ( n = 127 each group ) were referred for paediatric dental specialist care . Children in the ART-based group received more dental services than those allocated to the SC group ( mean = 3.8 , SD 2.0 and mean = 1.8 , SD 1.8 , respectively , Wilcoxon rank-sum test , P < 0.01 ) . Total costs of the ART-based approach and the SC group were $ 137 860 and $ 178 217 , respectively . Based on probabilistic sensitivity analysis , $ 654 was saved per referral to specialist avoided and $ 36 was saved per additional dental treatment . The probability that the ART-based approach is cost-saving was 63 % . Specialist dental treatment fees had a big impact on the cost-effectiveness estimates . CONCLUSION The ART-based approach appears to be a worthwhile intervention because it result ed in fewer referred cases and enabled more treatments to be provided with cost-savings OBJECTIVES A total of 3373 12-year-olds agreed to participate in an intervention study evaluating different caries preventive measures . The study , titled ' Evaluation of caries preventive measures ' , was performed between 1995 and 1999 at 26 dental health clinics throughout Sweden . At the start of the study , the subjects were classified as individuals at high or low risk of developing caries . The high-risk group consisted of 1165 subjects . The children in the high-risk group were r and omly assigned to one of four preventive programs . The programs represent a step-wise increase in fluoride content , contact with dental personnel and cost . The aim of the present cost-effectiveness analysis ( CEA ) study performed from a societal perspective is to compare costs and consequences of caries preventive programs in a caries high-risk population . By ' costs ' is meant both treatment costs and costs contributed by the patient and the patient 's family . Costs contributed by patients and their families consist of out-of-pocket expenses , transportation costs , and time . Conclusions are that it is important to consider the perspective from which a study is carried out . Costs contributed by the patient and the patient 's family have a high impact on total costs for children and younger adolescents but decrease with time as the adolescents get older . The present study shows an incremental cost-effectiveness of 2043 SEK (
Output:
| Conclusions There is a paucity of high- quality economic evaluations in the field of child oral health . |
MS210960 | ***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: Background The effectiveness of anterior cruciate ligament reconstruction for restoring normal knee kinematics is largely unknown , particularly during sports movements generating large , rapidly applied forces . Hypothesis Under dynamic in vivo loading , significant differences in 3-dimensional kinematics exist between anterior cruciate ligament-reconstructed knees and the contralateral , uninjured knees . Study Design Prospect i ve , in vivo laboratory study . Methods Kinematics of anterior cruciate ligament-reconstructed and contralateral ( uninjured ) knees were evaluated for 6 subjects during downhill running 4 to 12 months after anterior cruciate ligament reconstruction , using a 250 frame/s stereoradiographic system . Anatomical reference axes were determined from computed tomography scans . Kinematic differences between the uninjured and reconstructed limbs were evaluated with a repeated- measures analysis of variance . Results Anterior tibial translation was similar for the reconstructed and uninjured limbs . However , reconstructed knees were more externally rotated on average by 3.8 ± 2.3 ° across all subjects and time points ( P = .0011 ) . Reconstructed knees were also more adducted , by an average of 2.8 ± 1.6 ° ( P = .0091 ) . Although differences were small , they were consistent in all subjects . Conclusions Anterior cruciate ligament reconstruction failed to restore normal rotational knee kinematics during dynamic loading . Clinical Relevance Although further study is required , these abnormal motions may contribute to long-term joint degeneration associated with anterior cruciate ligament injury/reconstruction STUDY DESIGN Prospect i ve descriptive study . OBJECTIVE To determine the extent of bone mineral density ( BMD ) interlimb differences at several hip locations in the involved versus noninvolved lower extremity following anterior cruciate ligament ( ACL ) surgery . BACKGROUND Disuse following ACL reconstruction can be extensive . This disuse not only affects the soft tissue , but may also affect the skeletal structure . The extent of this disuse specific to the proximal femur has not been previously determined . METHODS AND MEASURES BMD was assessed in 15 subjects , 17 to 51 years old , who were between 6 and 32 months post-ACL reconstruction surgery . Bone mineral content ( BMC ) and BMD of the femoral neck , trochanteric region , intertrochanteric region , and entire hip were measured as a primary emphasis of this study . BMD and BMC of the entire lower extremities were also measured bilaterally . RESULTS BMD was significantly less in the involved lower extremity compared to noninvolved lower extremity at several hip sites : 6.6 % less ( P<.001 ) for the trochanteric region , 4.0 % less ( P<.001 ) for the entire hip , and 3.4 % less ( P = .004 ) for the intertrochanteric region . No significant differences were noted comparing the entire lower extremities for either BMD ( 0.9 % , P = .48 ) or BMC ( 3.7 % , P= .09 ) . CONCLUSION BMD differences at the hip are significant in patient 's postoperative ACL reconstruction , especially in the trochanteric region 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 Thirty-seven patients who had undergone anterior cruciate ligament reconstruction were tested in a gait analysis laboratory at 2 and 6 weeks after surgery . Between test sessions , patients were r and omly assigned to a course of either closed or open kinetic chain resistance exercises ( 3 sessions per week for 4 weeks ) . Gait analysis consisted of bilateral calculations of knee joint angle , moment , and power during level walking , stair ascent , and stair descent . An analysis of variance on the effects of training group and test session indicated that the only variable to be significantly affected by the type of exercise program was the amount of knee flexion at the beginning of step-up ( P<0.05 ) . All other measures of knee angle , moment , and power ( 16 total variables ) showed no significant difference between the exercise groups . All variables measured on the injured side showed significant improvement from test 1 to test 2 ( P<0.05 ) , but the injured leg remained functionally deficient when compared with the uninjured leg . These data suggest that there are no clinical ly significant differences in the functional improvement result ing from the choice of open or closed kinetic chain exercises in the early period after this surgery 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 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 OBJECTIVE To establish the gait adaptations of patients with anterior cruciate ligament deficiency during stair ascent . DESIGN Joint kinematics and kinetics during stair climbing were measured in both knees of normal subjects and unilateral anterior cruciate ligament deficient patients . BACKGROUND As there is limited research pertaining to activities other than level walking , the purpose of the current study was to eluci date the gait of patients with anterior cruciate ligament deficiency during stair climbing to determine the effects of the deficiency on knee joint motion and moments as compared with normal knee function . METHODS A motion analysis system was used to measure and calculate kinematic and kinetic data for six normal subjects and nine patients with unilateral anterior cruciate ligament deficiency during stair ascent on a specially constructed staircase . Left and right leg data were analysed to reveal between-limb differences for each subject . RESULTS Patients with anterior cruciate ligament deficiency displayed a significant ( P < 0.05 ) reduction of up to 50 % in peak knee flexion moments in their involved knee . In the present study where a step height of 15.5 cm was used , peak flexion moments in all subjects ' limbs occurred at knee flexion angles of about 40 degrees during single limb support . CONCLUSION The current study showed that most patients with an anterior cruciate deficient knee adapted their gait during stair ascent . RELEVANCE As stair climbing is a common activity , its effect on gait is relevant to better underst and appropriate treatment and management strategies of patients with anterior cruciate ligament deficient knees Background Athletes who return to sport participation after anterior cruciate ligament reconstruction ( ACLR ) have a higher risk of a second anterior cruciate ligament injury ( either reinjury or contralateral injury ) compared with non — anterior cruciate ligament— injured athletes . Hypotheses Prospect i ve measures of neuromuscular control and postural stability after ACLR will predict relative increased risk for a second anterior cruciate ligament injury . Study Design Cohort study ( prognosis ) ; Level of evidence , 2 . Methods Fifty-six athletes underwent a prospect i ve biomechanical screening after ACLR using 3-dimensional motion analysis during a drop vertical jump maneuver and postural stability assessment before return to pivoting and cutting sports . After the initial test session , each subject was followed for 12 months for occurrence of a second anterior cruciate ligament injury . Lower extremity joint kinematics , kinetics , and postural stability were assessed and analyzed . Analysis of variance and logistic regression were used to identify predictors of a second anterior cruciate ligament injury . Results Thirteen athletes suffered a subsequent second anterior cruciate ligament injury . Transverse plane hip kinetics and frontal plane knee kinematics during l and ing , sagittal plane knee moments at l and ing , and deficits in postural stability predicted a second injury in this population ( C statistic = 0.94 ) with excellent sensitivity ( 0.92 ) and specificity ( 0.88 ) . Specific predictive parameters included an increase in total frontal plane ( valgus ) movement , greater asymmetry in internal knee extensor moment
Output:
| Knees with ACLD showed less peak knee flexion compared with that on contralateral sides during stair ascent , with minimal heterogeneity .
External knee flexion moments were lower for ACLR compared with those in controls and contralateral sides during ascent and descent , whereas these moments were decreased for the ACLD compared with controls only during ascent .
Differences for kinematics and kinetics for the ACL-injured knees indicate long-term compensatory and asymmetric movement patterns while ascending and descending stairs . |
MS210961 | ***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 effectiveness of psychotropic medication withdrawal and a home-based exercise program in reducing falls in older people . DESIGN A r and omized controlled trial with a two by two factorial design . SETTING Seventeen general practice s in Dunedin , New Zeal and . PARTICIPANTS Women and men aged 65 years registered with a general practitioner and currently taking psychotropic medication ( n = 93 ) . INTERVENTIONS Two interventions : ( 1 ) gradual withdrawal of psychotropic medication versus continuing to take psychotropic medication ( double blind ) and ( 2 ) a home-based exercise program versus no exercise program ( single blind ) . MEASUREMENTS Number of falls and falls risk during 44 weeks of follow-up . Analysis was on an intent to treat basis . RESULTS After 44 weeks , the relative hazard for falls in the medication withdrawal group compared with the group taking their original medication was .34 ( 95 % CI , .16-.74 ) . The risk of falling for the exercise program group compared with those not receiving the exercise program was not significantly reduced . CONCLUSIONS Withdrawal of psychotropic medication significantly reduced the risk of falling , but permanent withdrawal is very difficult to achieve OBJECTIVE To determine whether a new model of primary care , Chronic Care Clinics , can improve outcomes of common geriatric syndromes ( urinary incontinence , falls , depressive symptoms , high risk medications , functional impairment ) in frail older adults . DESIGN R and omized controlled trial with 24 months of follow-up . Physician practice s were r and omized either to the Chronic Care Clinics intervention or to usual care . SETTING Nine primary care physician practice s that comprise an ambulatory clinic in a large staff-model HMO in western Washington State . PARTICIPANTS Those patients aged 65 and older in each practice with the highest risk for being hospitalized or experiencing functional decline . INTERVENTION Intervention practice s ( 5 physicians , 96 patients ) held half-day Chronic Care Clinics every 3 to 4 months . These clinics included an extended visit with the physician and nurse dedicated to planning chronic disease management ; a pharmacist visit that emphasized reduction of polypharmacy and high-risk medications ; and a patient self-management/support group . Control practice s ( 4 physicians , 73 patients ) received usual care . MEASUREMENTS Changes in self-reported urinary incontinence , frequency of falls , depressive symptoms , physical function , and satisfaction were analyzed using an intention-to-treat analysis adjusted for baseline differences , covariates , and practice -level variation . Prescriptions for high-risk medications and cost/utilization data obtained from administrative data were similarly analyzed . RESULTS After 24 months , no significant improvements in frequency of incontinence , proportion with falls , depression scores , physical function scores , or prescriptions for high risk medications were demonstrated . Costs of medical care including frequency of hospitalization , hospital days , emergency and ambulatory visits , and total costs of care were not significantly different between intervention and control groups . A higher proportion of intervention patients rated the overall quality of their medical care as excellent compared with control patients ( 40.0 % vs 25.3 % , P = .10 ) . CONCLUSIONS Although intervention patients expressed high levels of satisfaction with Chronic Care Clinics , improved outcomes for selected geriatric syndromes were not demonstrated . These findings suggest the need for developing greater system-wide support for managing geriatric syndromes in primary care and illustrate the challenges of conducting practice improvement research in a rapidly changing delivery system BACKGROUND Noncompliance is a major factor in the morbidity and unnecessary hospital readmissions for patients with heart failure . Several studies have aim ed to reduce rehospitalizations in heart failure patients through a comprehensive , multidisciplinary approach . Medication compliance was rarely measured in these studies or , when it was measured , the method employed was seldom valid . We aim ed at determining the effect of a pharmacist-led intervention on medication compliance in patients with heart failure . METHODS We conducted a r and omized controlled trial into the effect of a pharmacist-led intervention on medication compliance in patients with heart failure ( predominantly New York Heart Association [ NYHA ] II and III ) treated with loop diuretics , presenting to a cardiology outpatient clinic or admitted to hospitals in The Netherl and s. Patients in the intervention group received monthly consultations from their community pharmacist during a 6-month period . Patients in the control group received usual care . Primary endpoint was medication compliance , assessed with a medication event monitoring system , an electronic pill bottle that registers time of opening . Secondary endpoints were the number of rehospitalizations , death , and quality of life . RESULTS A total of 152 patients were r and omized : 74 patients to the intervention arm and 78 patients to the usual care arm . Over the 6-month study period , patients in the intervention group had 140/7656 days without use of loop diuretics compared with 337/6196 days in the usual care group ( relative risk 0.33 [ confidence interval ( CI ) 95 % 0.24 - 0.38 ] ) . Two consecutive days of nondosing occurred on 18/7656 days in the intervention group compared with 46/6196 days in the usual care group ( relative risk 0.32 [ CI 95 % 0.19 - 0.55 ] ) . There were no significant differences in rehospitalizations , mortality , or disease-specific quality of life between groups . CONCLUSIONS A pharmacy-led intervention can improve medication compliance in patients with moderate to severe heart failure , even in those with relatively high compliance . Future interventions should also focus at less compliant patients Abstract Objective : To assess the effect of a multifaceted intervention directed at general practitioners on six year mortality , morbidity , and risk factors of patients with newly diagnosed type 2 diabetes . Design : Pragmatic , open , controlled trial with r and omisation of practice s to structured personal care or routine care ; analysis after 6 years . Setting : 311 Danish practice s with 474 general practitioners ( 243 in intervention group and 231 in comparison group ) . Participants : 874 ( 90.1 % ) of 970 patients aged ≥40 years who had diabetes diagnosed in 1989 - 91 and survived until six year follow up . Intervention : Regular follow up and individualised goal setting supported by prompting of doctors , clinical guidelines , feedback , and continuing medical education . Main outcome measures : Predefined clinical non-fatal outcomes , overall mortality , risk factors , and weight . Results : Predefined non-fatal outcomes and mortality were the same in both groups . The following risk factor levels were lower for intervention patients than for comparison patients ( median values ) : fasting plasma glucose concentration ( 7.9 v 8.7 mmol/l , P=0.0007 ) , glycated haemoglobin ( 8.5 % v 9.0 % , P<0.0001 ; reference range 5.4 - 7.4 % ) , systolic blood pressure ( 145 v 150 mm Hg , P=0.0004 ) , and cholesterol concentration ( 6.0 v 6.1 mmol/l , P=0.029 , adjusted for baseline concentration ) . Both groups had lost weight since diagnosis ( 2.6 v 2.0 kg ) . Metformin was the only drug used more frequently in the intervention group ( 24 % ( 110/459 ) v 15 % (61/415)).Intervention doctors arranged more follow up consultations , referred fewer patients to diabetes clinics , and set more optimistic goals . Conclusions : In primary care , individualised goals with educational and surveillance support may for at least six years bring risk factors of patients with type 2 diabetes to a level that has been shown to reduce diabetic complications but without weight gain . What is already known on this topic Evidence is increasing that control of hyperglycaemia , hypertension , and dyslipidaemia may postpone the development of diabetic complications in patients with type 2 diabetes Maintaining good control over a long period can be difficult What this study adds Structured individualised personal care with educational and surveillance support for general practitioners reduced levels of risk factors in type 2 diabetic patients after six years Risk factors were reduced to a level that has been shown to have a beneficial effect on diabetic complications Participants also showed modest weight Abstract Objective : To determine whether a pharmacist can effectively review repeat prescriptions through consultations with elderly patients in general practice . Design : R and omised controlled trial of clinical medication review by a pharmacist against normal general practice review . Setting : Four general practice s. Participants : 1188 patients aged 65 or over who were receiving at least one repeat prescription and living in the community . Intervention : Patients were invited to a consultation at which the pharmacist review ed their medical conditions and current treatment . Main outcome measures : Number of changes to repeat prescriptions over one year , drug costs , and use of healthcare services . Results : 590 ( 97 % ) patients in the intervention group were review ed compared with 233 ( 44 % ) in the control group . Patients seen by the pharmacist were more likely to have changes made to their repeat prescriptions ( mean number of changes per patient 2.2 v 1.9 ; difference=0.31 , 95 % confidence interval 0.06 to 0.57 ; P=0.02 ) . Monthly drug costs rose in both groups over the year , but the rise was less in the intervention group ( mean difference £ 4.72 per 28 days , −£7.04 to -£2.41 ) ; equivalent to £ 61 per patient a year . Intervention patients had a smaller rise in the number of drugs prescribed ( 0.2 v 0.4 ; mean difference −0.2 , −0.4 to −0.1 ) . There was no evidence that review of treatment by the pharmacist affected practice consultation rates , outpatient consultations , hospital admissions , or death rate . Conclusions : A clinical pharmacist can conduct effective consultations with elderly patients in general practice to review their drugs . Such review results in significant changes in patients ' drugs and saves more than the cost of the intervention without affecting the workload of general practitioners . What is already known on this topic Review of patients on long term drug treatment is important but is done inadequately Evidence from the United States shows that pharmacists can improve patient care by review ing drug treatment What this study adds Consultations with a clinical pharmacist are an effective method of review ing the drug treatment of older patients Review by a pharmacist results in more drug changes and lower prescribing costs than normal care plus a much higher review rate Use of healthcare services by patients is not Twenty-seven independent community pharmacies that were preferred providers for a health maintenance organization ( HMO ) were enrolled in a study to determine the effect of increased intervention activities on the cost of a drug benefit in a managed care environment . Pharmacists from nine pharmacies were trained to initiate changes in medication prescriptions to contain costs , to enhance communication with patients and prescribers , and to intervene in drug-related problems . Their intervention activities during the nine-month study period were compared with activities of nine pharmacies assigned to a control group and nine pharmacies assigned to a comparison group . Patients who visited the intervention pharmacies had a 6.5 % lower prescription mean ingredient cost ; a 6.0 % higher generic substitution rate ; an 8.3 % lower average patient drug cost per month ; and no difference in the days supply , the average number of prescriptions per patient , or the aggregate hospital admission rate . The pharmacists in the intervention group spent more time with patients before preparing prescriptions ( 2.4-fold increase ) ; initiated more requests for prescribers to change prescriptions ( 2.5-fold increase ) ; intervened more often to reduce the cost of drug therapy ( 3.7-fold increase ) ; and suggested medication changes more often for better quality of care ( 1.9-fold increase ) . In this study , community pharmacists altered their practice procedures and setting s to foster communication with patients and prescribers . Also , the prospect i ve drug regimen review changed prescribing patterns : physicians permitted increased use of generic medications , which reduced monthly prescription expenditures Abstract Objective : To evaluate whether a programme of multifactorial home visits reduces falls and impairments in mobility in elderly people living in the community . Design : R and omised controlled trial with 18 months of follow up . Setting : Six general practice s in Hoensbroek , the Netherl and s. Participants : 316 people aged 70 and over living in the community , with moderate impairments in mobility or a history of recent falls . Intervention : Five home visits by a community nurse over a period of one year . Visits consisted of screening for medical , environmental , and behavioural factors causing falls and impairments in mobility , followed by specific advice , referrals , and other actions aim ed at dealing with the observed hazards . Main outcome measures : Falls and impairments in mobility . Results : No differences were found in falls and mobility outcomes between the intervention and usual care groups . Conclusion : Multifactorial home visits had no effects on falls and impairments in mobility in elderly people at risk who were living in the community . Because falls and impairments in mobility remain a serious problem among elderly people , alternative strategies should be developed and evaluated BACKGROUND regular medication review has been recommended for those over 75 and those on multiple drug therapy . Pharmacists are a potential source of assistance in review ing medication . Evidence of the benefits of this process is needed . OBJECTIVE to study the effect of medication review led by a pharmacist on resolution of pharmaceutical care issues , medicine costs , use of health and social services and health-related quality of life . DESIGN r and omized , controlled trial . SETTING general medical practice s in the Grampian region of Scotl and . SUBJECTS patients aged at least 65 years , with at least two chronic disease states who were taking at least four prescribed medicines regularly . METHODS pharmac
Output:
| There is relatively weak evidence to indicate that pharmacist-led medication review s are effective in reducing hospital admissions .
There is currently no evidence for the effectiveness of other interventions which aim at reducing admissions or preventable drug related morbidity . |
MS210962 | ***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 : Given the evidence that reasoning biases contribute to delusional persistence and change , several research groups have made systematic efforts to modify them . The current experiment tested the hypothesis that targeting reasoning biases would result in change in delusions . Methods : One hundred and one participants with current delusions and schizophrenia spectrum psychosis were r and omly allocated to a brief computerized reasoning training intervention or to a control condition involving computer-based activities of similar duration . The primary hypotheses tested were that the reasoning training intervention , would improve ( 1 ) data gathering and belief flexibility and ( 2 ) delusional thinking , specifically paranoia . We then tested whether the changes in paranoia were mediated by changes in data gathering and flexibility , and whether working memory and negative symptoms moderated any intervention effects . Results : On an intention-to-treat analysis , there were significant improvements in state paranoia and reasoning in the experimental compared with the control condition . There was evidence that changes in reasoning mediated changes in paranoia , although this effect fell just outside the conventional level of significance after adjustment for baseline confounders . Working memory and negative symptoms significantly moderated the effects of the intervention on reasoning . Conclusion : The study demonstrated the effectiveness of a brief reasoning intervention in improving both reasoning processes and paranoia . It thereby provides proof-of-concept evidence that reasoning is a promising intermediary target in interventions to ameliorate delusions , and thus supports the value of developing this approach as a longer therapeutic intervention The present study aim ed to investigate whether a brief reasoning training module changes the “ jumping to conclusions ” data gathering bias in people with delusions . A secondary aim was to examine whether improvements in reasoning would lead to greater flexibility in thinking about delusions . It was found that people with delusions and a diagnosis of schizophrenia ( n = 34 ) requested less information on a reasoning task compared with a non clinical control group ( n = 34 ) . The clinical group was then r and omly allocated to a session of reasoning training or to an attention control condition . Following training , participants showed a significant increase in data gathering , and a small number reported more flexibility and less conviction in their delusions , although this finding was not significant . The presence at baseline of an extreme reasoning bias moderated the effect of training . The study provides further confirmation of the jumping to conclusions bias and shows that data gathering can be improved , though the severest form of the bias is resistant to change . It is recommended that lengthier , delusion-related reasoning packages be developed and evaluated BACKGROUND A consistent body of studies suggests that schizophrenia patients are extremely hasty when making decisions , and generally opt for the strongest response alternative . This pattern of results is primarily based on studies conducted with the beads task , which requires participants to determine from which of two possible jars a series of beads has been drawn . We have recently proposed a liberal acceptance ( LA ) bias to account for decision-making biases in schizophrenia , which cl aims that under heightened ambiguity the jump to conclusions ( JTC ) bias is abolished in schizophrenia . METHODS A total of 37 schizophrenia patients were compared with 37 healthy controls on different versions of the beads paradigm . For the first task , participants were required to rate the probability that a bead was being drawn from one of two jars , and had to evaluate after each bead whether the amount of presented information would justify a decision . The second task was a classical draws to decision experiment with two jars . The third task confronted participants with four possible jars . If JTC was ubiquitous in schizophrenia hasty convergence on one alternative would be predicted for all three tasks . In contrast , the LA account predicts an abolishment of the JTC effect in the final task . RESULTS Tasks 1 and 2 provide further evidence for the well-replicated JTC pattern in schizophrenia patients . In accordance with the LA hypothesis , no group differences were detected for task 3 . DISCUSSION The present results confirm that JTC is not ubiquitous in schizophrenia : in line with the LA account a JTC bias in schizophrenia occurred under low but not high ambiguity . LA may partly explain the emergence of fixed , false beliefs People with delusions have been shown to have both generalized ( Huq , Garety & Hemsley , 1988 ) and content-specific biases in reasoning ( Bentall , 1994 ) . Our concern here was whether the hastiness that has been found when people with delusions reason on relatively abstract tasks would be present on a more realistic task . A second concern was whether reasoning with salient or emotional material would increase the hastiness bias in people with delusions . Two versions of a probabilistic reasoning task were used to study the data gathering of people with delusions . The first version employed realistic but emotionally neutral material . People with delusions requested less evidence before making a decision than psychiatric and normal comparison groups . Therefore , the hastiness found previously with abstract material s was seen to generalize to a more realistic task . In the second version participants were required to reason with material that had an emotional content and may have been regarded as being personally meaningful . In this condition all groups reduced the amount of evidence requested before making a decision Biases in cognition such as Jumping to Conclusions ( JTC ) and Verbal Self-Monitoring ( VSM ) are thought to underlie the formation of psychotic symptoms . This prospect i ve study in people with an At Risk Mental State ( ARMS ) for psychosis examined how these cognitive biases changed over time , and predicted clinical and functional outcomes . Twenty-three participants were assessed at clinical presentation and a mean of 31 months later . Performance on a JTC and VSM tasks were measured at both time points . Relationships to symptom severity , level of function and the incidence of psychotic disorder were then examined . The levels of symptoms , function and VSM all improved over time , while JTC was stable . Five participants ( 22 % ) developed a psychotic disorder during the follow-up period , but the risk of transition was not related to performance on either task at baseline , or to longitudinal changes in task performance . JTC performance correlated with symptom severity at baseline and follow-up . Similarly , performance on the two tasks was not related to the level of functioning at follow-up . Thus , while the ARMS is associated with both VSM and JTC biases , neither predict the onset of psychosis or the overall functional outcome
Output:
| Hence , nonaffective psychosis is characterized by a hasty decision-making style , which is linked to an increased probability of delusions |
MS210963 | ***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 This study developed and tested a culturally appropriate , church-based intervention to improve diabetes self-management . Research Design and Methods This was a r and omized trial conducted at 24 African American churches in central North Carolina . Churches were r and omized to receive the special intervention ( SI ; 13 churches , 117 participants ) or the minimal intervention ( MI ; 11 churches , 84 participants ) . The SI included an 8-month intensive phase , consisting of 1 individual counseling visit , 12 group sessions , monthly phone contacts , and 3 encouragement postcards , followed by a 4-month reinforcement phase including monthly phone contacts . The MI received st and ard educational pamphlets by mail . Outcomes were assessed at 8 and 12 months ; the primary outcome was comparison of 8-month A1C levels . Results At baseline , the mean age was 59 years , A1C 7.8 % , and body mass index 35.0 kg/m2 ; 64 % of participants were female . For the 174 ( 87 % ) participants returning for 8-month measures , mean A1C ( adjusted for baseline and group r and omization ) was 7.4 % for SI and 7.8 % for MI , with a difference of 0.4 % ( 95 % confidence interval [ CI ] , 0.1 - 0.6 , P = .009 ) . In a larger model adjusting for additional variables , the difference was 0.5 % ( 95 % CI , 0.2 - 0.7 , P < .001 ) . At 12 months , the difference between groups was not significant . Diabetes knowledge and diabetes-related quality of life significantly improved in the SI group compared with the MI group . Among SI participants completing an acceptability question naire , intervention components and material s were rated as highly acceptable . Conclusions The church-based intervention was well received by participants and improved short-term metabolic control Colorectal cancer screening has clear benefits in terms of mortality reduction ; however , it is still underutilized and especially among medically underserved population s , including African Americans , who also suffer a disproportionate colorectal cancer burden . This study consisted of a theory-driven ( health belief model ) spiritually based intervention aim ed at increasing screening among African Americans through a community health advisor-led educational series in 16 churches . Using a r and omized design , churches were assigned to receive either the spiritually based intervention or a nonspiritual comparison , which was the same in every way except that it did not contain spiritual/religious content and themes . Trained and certified peer community health advisors in each church led a series of two group educational sessions on colorectal cancer and screening . Study enrollees completed a baseline , 1-month , and 12-month follow-up survey at their churches . The interventions had significant pre – post impact on awareness of all four screening modalities , and self-report receipt of fecal occult blood test , flexible sigmoidoscopy , and colonoscopy . There were no significant study group differences in study outcomes , with the exception of fecal occult blood test utilization , whereas those in the nonspiritual intervention reported significantly greater pre – post change . Both of these community-engaged , theory-driven , culturally relevant approaches to increasing colorectal cancer awareness and screening appeared to have an impact on study outcomes . Although adding spiritual/religious themes to the intervention was appealing to the audience , it may not result in increased intervention efficacy OBJECTIVES Body and Soul was a collaborative effort among two research universities , a national voluntary agency ( American Cancer Society ) , and the National Institutes of Health to disseminate and evaluate under real-world conditions the impact of previously developed dietary interventions for African Americans . METHODS Body and Soul was constructed from two successful research -based interventions conducted in African-American churches . Components deemed essential from the prior interventions were combined , and then tested in a cluster r and omized-effectiveness trial . The primary outcome was fruit and vegetable intake measured with two types of food frequency question naires at baseline and 6-month follow-up . RESULTS At the 6-month follow-up , intervention participants showed significantly greater fruit and vegetable ( F&V ) intake relative to controls . Post-test differences were 0.7 and 1.4 servings for the 2-item and 17-item F&V frequency measures , respectively . Statistically significant positive changes in fat intake , motivation to eat F&V , social support , and efficacy to eat F&V were also observed . CONCLUSIONS The results suggest that research -based interventions , delivered collaboratively by community volunteers and a health-related voluntary agency , can be effectively implemented under real-world conditions OBJECTIVE The purpose of this study was to examine a church-based intervention employing a 6-month pilot weight loss program as a strategy to improve health of African-American adults . DESIGN A r and omized trial design was used without a control group . Eligible church members were r and omized into two groups : an intervention delivered in the group setting and an intervention delivered in the individual setting . SETTING The study was conducted at an African-American church in Baton Rouge , Louisiana . PARTICIPANTS Forty church members were enrolled in the study . Two trained church members without specialization in obesity treatment conducted the study . MAIN OUTCOME MEASURES The primary outcome measure was weight loss . RESULTS The program retention rate was 90 % . After six months , a modest but significant mean weight loss was seen in all participants of 3.3 kg . The mean weight losses in the individual and group interventions were 3.4 kg and 3.1 kg , respectively . The mean body fat loss was 2.1 kg and 1.9 kg , respectively . The difference in weight loss and fat loss between the individual and group interventions was not statistically significant . An improvement in the quality of life and an increase in physical activity were reported by the program participants . CONCLUSIONS A church setting may provide an effective delivery mechanism for a health and nutrition program . Church members may be trained to conduct a weight control program . Both interventions ( individual and group ) were effective in inducing weight loss OBJECTIVES This study assessed the effects of the Black Churches United for Better Health project on increasing fruit and vegetable consumption among rural African American church members in North Carolina . METHODS Ten counties comprising 50 churches were pair matched and r and omly assigned to either intervention or delayed intervention ( no program until after the follow-up survey ) conditions . A multicomponent intervention was conducted over approximately 20 months . A total of 2519 adults ( 77.3 % response rate ) completed both the baseline and 2-year follow-up interviews . RESULTS The 2 study groups consumed similar amounts of fruits and vegetables at baseline . AT the 2-year follow-up , the intervention group consumed 0.85 ( SE = 0.12 ) servings more than the delayed intervention group ( P < .0001 ) . The largest increases were observed among people 66 years or older ( 1 serving ) , those with education beyond high school ( 0.92 servings ) , those widowed or divorced ( 0.96 servings ) , and those attending church frequently ( 1.3 servings ) . The last improvement occurred among those aged 18 to 37 years and those who were single . CONCLUSIONS The project was a successful model for achieving dietary change among rural African Americans Background Despite a significant decrease in smoking prevalence over the past ten years , cigarette smoking still represents the leading cause of preventable morbidity and mortality in the United States . Moreover , smoking prevalence is significantly higher among those with low levels of education and those living at , or below , the poverty level . These groups tend to be confronted with significant barriers to utilizing more traditional smoking cessation intervention approaches . The purpose of the study , Project ACTION ( Adult smoking Cessation Treatment through Innovative Outreach to Neighborhoods ) , is to utilize a mobile clinic model , a network of community sites ( i.e. , community centers and churches ) and an interactive mobile messaging system to reach and deliver smoking cessation treatment to underserved , low-income communities . Methods / Design We are using a group-r and omized design , with the community site as the sampling unit , to compare the efficacy of three smoking cessation interventions : 1 ) St and ard Care - brief advice to quit smoking , nicotine replacement therapy ( NRT ) , and self-help material s ; 2 ) Enhanced Care - st and ard care components plus a cell phone-delivered text/graphical messaging component ; and 3 ) Intensive Care - enhanced care components plus a series of 11 cell phone-delivered proactive counseling sessions . An economic evaluation will also be performed to evaluate the relative cost effectiveness of the three treatment approaches . We will recruit 756 participants ( 252 participants in each of the 3 intervention groups ) . At the time of r and omization , participants complete a baseline assessment , consisting of smoking history , socio-demographic , and psychosocial variables . Monthly cell phone assessment s are conducted for 6 months-post enrollment , and a final 12-month follow-up is conducted at the original neighborhood site of enrollment . We will perform mixed-model logistic regression to compare the efficacy of the three smoking cessation intervention treatment groups . Discussion It is hypothesized that the intensive care approach will most successfully address the needs of the target population and result in the highest smoking cessation rates . In addition to increasing cessation rates , the intervention offers several features ( including neighborhood outreach and use of mHealth technology ) that are likely to reduce treatment barriers while enhancing participant engagement and retention to treatment . Trial registration This r and omized controlled trial is registered with clinical trials.gov registration number NCT00948129 Introduction Physical activity participation is low among blacks , and strategies are needed to successfully create immediate and sustained behavior change related to physical activity . Churches can play an important role in health promotion efforts among blacks because of their central role in spiritual guidance , communication , social support , and networking . This pilot study evaluated the feasibility and acceptability of implementing a physical activity program for sedentary black adults in churches . Methods We used a preintervention/postintervention single-group design to evaluate the effect of a 3-month faith-based physical activity intervention on daily walking and moderate- and vigorous-intensity physical activity among sedentary blacks . Eighty-seven black adults participated in eight group sessions that included discussion of physical activity-related topics , an instructor-led physical activity session , and weekly incentives to promote physical activity . We used a question naire to assess moderate and vigorous physical activity in minutes per week at baseline and after 3 months . Walking was assessed weekly in steps per day by using a pedometer . Results Participants ( mean age , 52 yrs ; mean body mass index , 35 kg/m2 ) reported 27 ± 54 and 10 ± 25 minutes per week in moderate-intensity and vigorous-intensity physical activity , respectively , and walked 4822 ± 2351 steps per day at baseline . After 12 weeks , moderate- and vigorous-intensity physical activity increased by 67 ± 78 and 44 ± 66 minutes per week , respectively ( P ≤ .01 ) , and daily walking increased by 1373 ± 728 steps per day ( P < .001 ) . Conclusion These data suggest that a faith-based physical activity intervention may be an appropriate strategy for increasing physical activity among sedentary black adults . Future research will determine the impact of this program in a r and omized , controlled design Objective . The authors tested the impact on cardiovascular risk profiles of African American women ages 40 years and older after one year of participation in one of three church-based nutrition and physical activity strategies : a st and ard behavioral group intervention , the st and ard intervention supplemented with spiritual strategies , or self-help strategies . Methods . Women were screened at baseline and after one year of participation . The authors analyzed intention-to-treat within group and between groups using a generalized estimating equations adjustment for intra-church clustering . Because spiritual strategies were added to the st and ard intervention by participants themselves , the results from both active groups were similar and , thus , combined for comparisons with the self-help group . Results . A total of 529 women from 16 churches enrolled . Intervention participants exhibited significant improvements in body weight ( −1.1 lbs ) , waist circumference ( −0.66 inches ) , systolic blood pressure ( −1.6 mmHg ) , dietary energy ( −117 kcal ) , dietary total fat ( −8 g ) , and sodium intake ( −145 mg ) . The self-help group did not . In the active intervention group , women in the top decile for weight loss at one year had even larger , clinical ly meaningful changes in risk outcomes ( −19.8 lbs ) . Conclusions . Intervention participants achieved clinical ly important improvements in cardiovascular disease risk profiles one year after program initiation , which did not occur in the self-help group . Church-based interventions can significantly benefit the cardiovascular health of African American women OBJECTIVES This study reports on Eat for Life , a multicomponent intervention to increase fruit and vegetable consumption among African Americans that was delivered through Black churches . METHODS Fourteen churches were r and omly assigned to 3 treatment conditions : ( 1 ) comparison , ( 2 ) self-help intervention with 1 telephone cue call , and ( 3 ) self-help with 1 cue call and 3 counseling calls . The telephone counseling in group 3 was based on motivational interviewing . The primary outcome , assessed at baseline and 1-year follow-up , was fruit and vegetable intake as assessed by 3 food frequency question naires . RESULTS Change in fruit and vegetable intake was significantly greater in the motivational interviewing group than in the comparison and self-help groups . The net difference between the motivational interviewing and comparison groups was 1.38 , 1.03 , and 1.21 servings of fruits and vegetables per day for the 2-item , 7-item , and 36-item food frequency question naires , respectively . The net difference between the motivational interviewing and self-help groups was 1.
Output:
| These results suggest that interventions in African American FBOs can successfully improve weight and related behaviours .
However , not all of the findings about the success of certain approaches were as expected . |
MS210964 | ***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 functional polymorphism in the promoter region of the dopamine D2 receptor gene , the -141C Del allele , which may be associated with schizophrenia susceptibility , has previously been described in a Japanese sample . The present study was done in order to examine whether such an association would also be found in a North American schizophrenia patient population . However , analysis of the -141C Del allele frequency in the present group of schizophrenia patients ( n = 50 ) and control subjects ( n = 51 ) did not identify any significant differences . These data support the recent reports on German and British subjects that this genetic variation in the 5'-flanking region of the dopamine D2 receptor gene does not play a major role in the genetic predisposition to schizophrenia Previous studies have demonstrated that subjects with one or two A1 alleles of dopamine D2 receptor ( DRD2 ) polymorphism at the Taq1 A locus have lower DRD2 density than those with no A1 allele . The present study aim ed to examine whether the Taq1 A DRD2 genotypes are related to therapeutic response to nemonapride , a selective dopamine antagonist , in schizophrenic patients . The subjects were 25 acutely exacerbated schizophrenic in patients who had received no medication for at least 1 month before the study . The fixed dose ( 18 mg/day ) of nemonapride was administered to each patient for 3 weeks . The clinical status was prospect ively monitored by the Brief Psychiatric Rating Scale ( BPRS ) before , and 3 weeks after , the treatment . The Taq1 A genotypes ( A1 and A2 alleles ) were determined by the polymerase chain reaction method . Three patients were homozygous for the A1 allele , 11 were heterozygous for the A1 and A2 alleles , and 11 were homozygous for the A2 allele . The patients with one or two A1 alleles ( n = 14 ) showed significantly higher percentage improvement in total BPRS and positive symptoms than those with no A1 allele ( n = 11 ) after 3-week treatment while the percentage improvement in other subgrouped symptoms ( negative , anxiety-depression , excitement and cognitive symptoms ) was similar between the two genotype groups . The present results suggest that the Taq1 A DRD2 polymorphism is related to early therapeutic response to nemonapride in schizophrenic patients , possibly by modifying the efficiency of DRD2 antagonism of the drug in the central nervous system The relationship between Taq1 A polymorphism of dopamine D(2 ) receptor ( DRD(2 ) ) gene and extrapyramidal adverse effects of bromperidol and nemonapride , which are both antipsychotic drugs with selective and potent DRD(2 ) antagonistic property , was investigated in Japanese schizophrenic in patients . Twenty-seven patients were treated with bromperidol at 6 or 12 or 18 mg/day , while 25 patients were treated with nemonapride at 18 mg/day . The duration of treatment was 3 weeks . The A1 and A2 alleles were determined by PCR . The extrapyramidal adverse effects were assessed by the Udvalg for Kliniske Unders¿ogelser side effects rating scale . Six patients were homozygous for the A1 allele , 27 were heterozygous for the A1 and A2 alleles , and 19 were homozygous for the A2 allele . There were no significant differences in the incidences or severity of extrapyramidal adverse effects between the patients with one or two A1 alleles and those with no A1 allele . The present study suggests that Taq1 A polymorphism is not related to the development of extrapyramidal adverse effects during acute phase of bromperidol and nemonapride treatments Neuroleptic drugs have a high affinity for the dopamine D2 receptor ( DRD2 ) ; therefore DRD2 is thought to be a c and i date gene for schizophrenia . Arinami et al. have reported a positive association between schizophrenia and the Cys311 variant of the DRD2 gene . We determined the allele frequency of this polymorphism in 78 Okinawan schizophrenic patients and 112 control subjects . The patients and controls did not differ significantly in allele frequencies of Cys311 The result of most association studies and linkage analyses have suggested a negative association between schizophrenia and D2-like ( D2 , D3 , and D4 ) receptor polymorphisms . Although the polymorphisms of the D2-like receptor in themselves may not account for the etiology of schizophrenia , they can contribute to the severity of the symptoms . Thus , we studied the associations between the polymorphisms and their combinations , and the vulnerability of schizophrenics . Fragments of the D2-like receptor genes were amplified by means of the polymerase chain reaction , and the polymorphisms were identified by the restriction fragment length polymorphism and single-str and ed conformation polymorphism methods . There were no statistically significant differences in the polymorphisms and their combinations between schizophrenics and controls . Schizophrenics with D4E1(A1/A2 ) , which contains 2 and 1 t and em repeats of a 12-base-pair sequence in exon 1 , had a lower total positive symptom score before medication than schizophrenics with D4E1(A1/A1 ) . There was no association between the polymorphisms and negative symptoms
Output:
| Conclusion Our meta- analysis suggests an association of the DRD2 gene and the risk for schizophrenia , given that TaqI and C957 T polymorphisms presented a protective effect against schizophrenia , and in the sub-analyses the C957 T variant increased the risk for this disorder in the Chinese population |
MS210965 | ***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 30 human subjects , experimental pain was produced by either ischemia or cold-water immersion . In a double-blind procedure , intravenous doses of up to 10 milligrams of naloxone hydrochloride in saline were indistinguishable from similarly administered saline alone . There were no effects on subjective pain ratings , finger plethysmograph recordings , or responses to mood-state question naires . These laboratory procedures do not activate any functionally significant pain-attenuating or mood-altering effect of endorphins The analgesic effects of the synthetic opiate fentanyl citrate ( 0.1 mg ) on subjective pain reports ( SPR ) and late-wave event-related potentials ( ERP ) recorded during painful dental stimulation were examined in human subjects . Such waves have been shown to reflect the contribution of cognitive variables , such as expectancy and belief , to perception . In addition , the study was intended to demonstrate a dose-related narcotic antagonism with injection of naloxone ( 1.2 or 0.4 mg ) or normal saline ( double-blind ) following IV fentanyl administration . Fentanyl reduced both ERP waveform amplitudes and SPR as have previously studied analgesic agents , such as nitrous oxide , acupuncture , and aspirin . Naloxone injection reversed both ERP and SPR changes , but surprisingly , a reversal of narcotic analgesia equal to that of 0.4 mg naloxone was seen with saline injection . By change , all subjects were health-science students or professionals who were knowledgeable in opiate pharmacology , and so placebo reversal was hypothesized . Alternatively , it was hypothesized that fentanyl cleared more rapidly than predicted , thus , producing apparent reversal . In a second experiment involving similarly knowledgeable subjects with identical procedures and testing intervals , subjects received 0.1 mg fentanyl , but no reversal injection . The fentanyl effect was constant across this time period . The data , thus support the hypothesis that the saline-induced reversal seen in experiment 1 , where the subjects were knowledgeable in opiate pharmacology , was placebo opiate antagonism & NA ; Discovery of the involvement of endogenous opiates in placebo analgesia represents an important step in underst and ing the mechanisms underlying placebo response . In the present study , we investigated the effects of the opiate antagonist naloxone and the cholecystokinin antagonist proglumide on placebo analgesia in a human model of experimentally induced ischemic pain . First , we found that part of the placebo response was reversed by naloxone , confirming previous studies on the role of opioids in the placebo phenomenon . Second , since it was demonstrated that the action of exogenous and endogenous opiates is potentiated by proglumide , we analysed the effects of this cholecystokinin antagonist on placebo response and found that it enhanced placebo analgesia . The placebo effect can thus be modulated in two opposite directions : it can be partially abolished by naloxone and potentiated by proglumide . The fact that placebo potentiation by proglumide occurred only in placebo responders , but not in non‐responders , suggests that activation of an endogenous opiate system is a necessary condition for the action of proglumide . These results suggest an inhibitory role for cholecystokinin in placebo response , although the low affinity of proglumide for cholecystokinin receptors does not rule out the possibility of other mechanisms
Output:
| Due to their sophisticated design s , these studies probably provide the best evidence that placebo analgesia exists .
They also indicate that placebo analgesia is mediated by endogenous opiates . |
MS210966 | ***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: AIMS This multicentre prospect i ve r and omised trial was undertaken to evaluate the usefulness of an electrophysiological study (EPS)-guided/implantable cardioverter defibrillator ( ICD ) strategy in patients at high risk of sudden death ( SD ) early after myocardial infa rct ion ( MI ) . Previous studies have shown the benefits of such a strategy only in high-risk patients late after MI . METHODS AND RESULTS We enrolled 143 survivors of acute MI ( < 1 month ) with left ventricular ejection fraction < or = 35 % and either frequent ( > or = 10/h ) premature ventricular complexes ( PVCs ) , or depressed heart rate variability ( SDNN < 70 ms ) or abnormal signal-averaged ECG , who were able to tolerate optimised beta-blocker therapy ( 68 + /- 40 mg/day of metoprolol ) . Of these , 138 were r and omised , in a 2:3 ratio , to two therapeutic strategies : conventional ( CONV ) strategy ( n = 59 ) or EPS-guided/ICD strategy ( n = 79 ) . The latter result ed in ICD implantation in 24 inducible patients and in CONV therapy in the remaining 55 . During a mean follow-up of 540 + /- 378 days , 26 patients ( 19 % ) died : nine ( 6.5 % ) SD , nine ( 6.5 % ) non-SD , and four ( 3 % ) non-cardiac death ; in four patients ( 3 % ) the cause of death was unknown . The actuarial overall mortality for the CONV and EPS-guided/ICD arms was 18 % vs 14 % after 1 year and 29.5 % vs 20 % after 2 years , respectively ( P = 0.3 and 0.2 ) . CONCLUSIONS Despite optimal therapy , mortality remains significant in high-risk patients following MI . Although there is a trend in favour of EPS-guided/ICD , our data are insufficient to demonstrate a survival benefit of this strategy early after MI STUDY OBJECTIVES Pocket hematoma is a common complication after pacemaker or implantable cardioverter defibrillator ( ICD ) implantation . Thus , we investigated the influence of patient comorbidity , implantation strategy , operator experience , antiplatelet therapy , and anticoagulation therapy on hematoma rate . DESIGN Between 1990 and 2002 , a total of 3,164 devices ( pectoral pacemakers , 2,792 ; ICDs , 372 ) were implanted at our institution . Predictors of hematoma occurrence were determined prospect ively and were analyzed by multivariate regression analysis . Operator experience was grade d by individual implantation number , as follows : low , < 50 ; medium , 50 to 100 ; and high , > 100 . RESULTS The incidence of pocket hematoma was 4.9 % , leading to prolonged hospitalization in 2.0 % of all patients . Reoperation for pocket hematoma was required in 1.0 % of patients . High-dose heparinization ( hazard ratio [ HR ] , 4.2 ) , combined acetylsalicylic acid (ASA)/thienopyridine treatment after coronary stenting ( HR , 5.2 ) , and low operator experience ( HR , 1.6 ) were independently predictive of hematoma development . Therapy with ASA alone did not increase the hematoma rate compared to patients who did receive antiplatelet or anticoagulation therapy ( 3.1 % vs 2.5 % , respectively ; difference not significant ) . In patients with nonvalvular atrial fibrillation , postoperative high-dose heparinization substantially increased the hematoma rate ( 10.7 % vs 2.9 % , respectively ; p < 0.001 ) without reducing the rate of arterial embolism within the first month after implantation ( 0.18 % vs 0.21 % , respectively ; difference not significant ) . The infection rate ( 0.28 % within 3 months after implantation ) was not influenced by the presence of the pocket hematoma . CONCLUSIONS The use of high-dose heparinization and combined ASA/thienopyridine treatment are highly predictive for the occurrence of intraoperative bleeding and pocket hematoma in patients who have undergone pacemaker and ICD surgery . We propose recommendations for the management of antiplatelet and anticoagulation therapy in patients undergoing these interventions AIMS Electrical storm ( ES ) is a life-threatening arrhythmia complication affecting patients treated with an implantable cardioverter defibrillator ( ICD ) . Despite its increasing importance , existing data on prognosis and management of ICD patients affected by ES are limited and conflicting . METHODS We prospect ively studied 169 consecutive patients receiving an ICD . Thirty-two patients presented with at least one episode of ES during the period of observation ( 33+/-26 months ) . ES patients were older ( 64+/-9 vs. 59+/-13 years , P=0.013 ) with more advanced congestive heart failure ( CHF ) but a similar incidence of an underlying organic heart disease . RESULTS Long-term total and cardiac mortality were both increased among ES patients . Seventeen of the 32 ES patients died as opposed to 19 of the 137 ICD patients without ES ( 53 vs. 14 % , P<0.001 ) . In multivariate Cox regression analysis adjusted for the main confounders , history of ES was significantly and independently associated with total and cardiac mortality ( risk ratio (RR)=2.13 , P=0.031 and RR=2.59 , P=0.019 , respectively ) . CONCLUSION ES is a relatively frequent complication affecting ICD patients treated for secondary prevention of sudden cardiac death ( SCD ) . Although the acute management of this serious arrhythmia complication is usually successful , occurrence of ES is a strong independent predictor of poor outcome in ICD patients BACKGROUND Implantable cardioverter-defibrillators ( ICDs ) have been shown in primary prevention efficacy trials to reduce mortality in patients with ischemic heart disease and left ventricular dysfunction . To investigate the generalizabilty of this mortality reduction , we examined the effectiveness of ICDs in clinical practice . METHODS We developed a prospect i ve multicenter cohort of 770 patients with ischemic left ventricular dysfunction ( ejection fraction < or = 35 % ) and without a history of ventricular arrhythmia , of whom 395 ( 52 % ) received ICDs . Mean + /- SD follow-up was 27 + /- 12 months . We assessed the degree to which ICDs decreased mortality risk using Cox proportional hazards analyses that controlled for clinical predictors of death , receipt of ICD ( a propensity score analysis ) , and predictors of arrhythmic death ( including electrophysiologic variables ) . RESULTS Multivariate Cox analyses showed that those with ICDs had significantly lower all-cause mortality ( hazard ratio [ HR ] , 0.53 ; 95 % confidence interval [ CI ] , 0.33 - 0.86 ) . This mortality reduction was mediated through dramatically lower arrhythmia-related mortality ( HR , 0.35 ; 95 % CI , 0.17 - 0.73 ) , with no significant effect on cardiovascular nonarrhythmic ( HR , 0.81 ; 95 % CI , 0.34 - 1.96 ) and noncardiovascular ( HR , 0.76 ; 95 % CI , 0.29 - 2.05 ) mortality . No differences were found between the ICD and non-ICD groups for a composite outcome of all-cause mortality , appropriate ICD shocks , or documented symptomatic ventricular arrhythmia , which suggests that the 2 groups had similar baseline risk for life-threatening arrhythmic events ( HR , 0.96 ; 95 % CI , 0.63 - 1.45 ) . CONCLUSION In clinical practice , ICDs appear to reduce all-cause and arrhythmic rates of mortality at levels similar to those found in primary prevention trials Monitoring of atrial rhythm in patients implanted with ICDs may improve accuracy in identifying supraventricular arrhythmias and , therefore , prevent inappropriate therapies . Since difficulties were found in dual chamber ICDs with separate leads , a new design ed single lead dual chamber ICD system was tested . Twenty-five patients implanted with a Deikos A+ ( single coil defibrillation lead with two atrial sensing rings combined with a dual chamber ICD with a high amplifying atrial channel ) were tested . Atrial and ventricular signals were analyzed during sinus rhythm ( SR ) and sinus tachycardias ( STs ) , atrial flutter and AF , and VT or VF . Follow-ups were performed after 1 , 3 , 6 , 9 , and 12 months after implantation . Analysis of EGM amplitudes of stored episodes revealed that atrial signals during atrial flutter ( 2.1 + /- 0.51 mV ) were comparable to those of ST ( 2.2 + /- 0.5 mV ) . Atrial amplitudes during AF were significantly lower ( 0.81 + /- 0.5 mV , P<0.01 ) . During VF atrial " sinus " signals ( 2 + /- 0.8 mV ) were stable . Ventricular parameters did not differ from a st and ard ICD lead ; defibrillation threshold was 11.4 + /- 4.5 J ( 16 patients ) . During intraoperative and prehospital discharge measurements , 97.1 % of SR-P waves and 99.2 % of atrial flutter waves were detected correctly . In AF 91.11 % of atrial signals were detected . Analysis of 505 stored episodes showed that 96.8 % of ST and 100 % of atrial flutter and 100 % of AF episodes have been classified correctly and no underdetection of VT/VF was found . The first experiences with the new VDD-ICD system show an increase of the specificity to detect ventricular tachycardias to a level comparable to dual chamber ICDs with two leads . The reliability of this system has to be proven in a prospect i ve r and omized study OBJECTIVES The purpose of this multicenter r and omized trial was to compare total mortality during therapy with amiodarone or an implantable cardioverter-defibrillator ( ICD ) in patients with nonischemic dilated cardiomyopathy ( NIDCM ) and nonsustained ventricular tachycardia ( NSVT ) . BACKGROUND Whether an ICD reduces mortality more than amiodarone in patients with NIDCM and NSVT is unknown . METHODS One hundred three patients with NIDCM , left ventricular ejection fraction < or = 0.35 , and asymptomatic NSVT were r and omized to receive either amiodarone or an ICD . The primary end point was total mortality . Secondary end points included arrhythmia-free survival , quality of life , and costs . RESULTS The study was stopped when the prospect i ve stopping rule for futility was reached . The percent of patients surviving at one year ( 90 % vs. 96 % ) and three years ( 88 % vs. 87 % ) in the amiodarone and ICD groups , respectively , were not statistically different ( p = 0.8 ) . Quality of life was also similar with each therapy ( p = NS ) . There was a trend with amiodarone , as compared to the ICD , towards improved arrhythmia-free survival ( p = 0.1 ) and lower costs during the first year of therapy ( $ 8,879 US dollars vs. $ 22,039 US dollars , p = 0.1 ) . CONCLUSIONS Mortality and quality of life in patients with NIDCM and NSVT treated with amiodarone or an ICD are not statistically different . There is a trend towards a more beneficial cost profile and improved arrhythmia-free survival with amiodarone therapy Background — Delivery of inappropriate shocks caused by misdetection of supraventricular tachycardia ( SVT ) remains a substantial complication of implanted cardioverter/defibrillator ( ICD ) therapy . Whether use of optimally programmed dual-chamber ICDs lowers this risk compared with that in single-chamber ICDs is not clear . Methods and Results — Subjects with a clinical indication for ICD ( n=400 ) at 27 participating centers received dual-chamber ICDs and were r and omly assigned to strictly defined optimal single- or dual-chamber detection in a single-blind manner . Programming minimized ventricular pacing . The primary end point was the proportion of SVT episodes inappropriately detected from the time of programming until crossover or end of study . On a per-episode basis , 42 % of the episodes in the single-chamber arm and 69 % of the episodes in the dual-chamber arm were due to SVT . Mortality ( 3.5 % in both groups ) and early study withdrawal ( 14 % single-chamber , 11 % dual-chamber ) were similar in both groups . The rate of inappropriate detection of SVT was 39.5 % in the single-chamber detection arm compared with 30.9 % in the dual-chamber arm . The odds of inappropriate detection were decreased by almost half with the use of the dual-chamber detection enhancements ( odds ratio , 0.53 ; 95 % confidence interval , 0.30 to 0.94 ; P=0.03 ) . Conclusions — Dual-chamber ICDs , programmed to optimize detection enhancements and to minim
Output:
| In a series of univariate meta-regression sensitivity analyses , none of the covariates we examined ( duration of follow-up , primary vs. secondary prevention , ischemic cause , presence of cardiac resynchronization therapy , NYHA class , mean age , mean LVEF , or mean QRS duration ) contributed to the moderate statistical heterogeneity observed in our meta- analysis of all-cause mortality . |
MS210967 | ***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: Abstract Objective : To evaluate the effect of intensive geriatric rehabilitation on demented patients with hip fracture . Design : Preplanned sub analysis of r and omised intervention study . Settting : Jyväskylä Central Hospital , Finl and . Participants : 243 independently living patients aged 65 years or older admitted to hospital with hip fracture . Intervention : After surgery patients in the intervention group ( n=120 ) were referred to the geriatric ward whereas those in the control group were discharged to local hospitals . Main outcome measures : Length of hospital stay , mortality , and place of residence three months and one year after surgery for hip fracture . Results : The median length of hospital stay of hip fracture patients with moderate dementia ( mini mental state examination score 12 - 17 ) was 47 days in the intervention group ( n=24 ) and 147 days in the control group ( n=12 , P=0.04 ) . The corresponding figures for patients with mild dementia ( score 18 - 23 ) were 29 days in the intervention group ( n=35 ) and 46.5 days in the control group ( n=42 , P=0.002 ) . Three months after the operation , in the intervention group 91 % ( 32 ) of the patients with mild dementia and 63 % ( 15 ) of the patients with moderate dementia were living independently . In the control group , the corresponding figures were 67 % ( 28 ) and 17 % ( 2 ) . There were no significant differences in mortality or in the lengths of hospital stay of severely demented patients and patients with normal mini mental state examination scores . Conclusions : Hip fracture patients with mild or moderate dementia can often return to the community if they are provided with active geriatric rehabilitation Background : An orthopaedic management/patient‐focused care unit ( OMPFCU ) involving a dedicated orthopaedic – geriatrics liaison team was established at the Royal Brisbane Hospital in 1994 in an effort to safely accelerate rehabilitation of patients with proximal femoral fractures Des vieillards atteints de fracture du femur sont suivis pendant 1 an , avec ou sans traitement de reeducation specialisee . Survie a 1 an : 67 % des temoins , 81 % des malades reeduques . 69 % des malades reeduques peuvent vivre de nouveau dans leur ancien domicile , contre 39 % seulement des OBJECTIVES Delirium ( or acute confusional state ) affects 35 % to 65 % of patients after hip-fracture repair , and has been independently associated with poor functional recovery . We performed a r and omized trial in an orthopedic surgery service at an academic hospital to determine whether proactive geriatrics consultation can reduce delirium after hip fracture . DESIGN Prospect i ve , r and omized , blinded . SETTING Inpatient academic tertiary medical center . PARTICIPANTS 126 consenting patients 65 and older ( mean age 79 + /- 8 years , 79 % women ) admitted emergently for surgical repair of hip fracture . MEASUREMENTS Detailed assessment through interviews with patients and design ated proxies and review of medical records was performed at enrollment to ascertain prefracture status . Subjects were then r and omized to proactive geriatrics consultation , which began preoperatively or within 24 hours of surgery , or " usual care . " A geriatrician made daily visits for the duration of the hospitalization and made targeted recommendations based on a structured protocol . To ascertain study outcomes , all subjects underwent daily , blinded interviews for the duration of their hospitalization , including the Mini-Mental State Examination ( MMSE ) , the Delirium Symptom Interview ( DSI ) , and the Memorial Delirium Assessment Scale ( MDAS ) . Delirium was diagnosed using the Confusion Assessment Method ( CAM ) algorithm . RESULTS The 62 patients r and omized to geriatrics consultation were not significantly different ( P>.1 ) from the 64 usual-care patients in terms of age , gender , prefracture dementia , comorbidity , type of hip fracture , or type of surgical repair . Sixty-one percent of geriatrics consultation patients were seen preoperatively and all were seen within 24 hours postoperatively . A mean of 10 recommendations were made throughout the duration of the hospitalization , with 77 % adherence by the orthopedics team . Delirium occurred in 20 /62 ( 32 % ) intervention patients , versus 32 / 64 ( 50 % ) usual-care patients ( P = .04 ) , representing a relative risk of 0.64 ( 95 % confidence interval ( CI ) = 0.37 - 0.98 ) for the consultation group . One case of delirium was prevented for every 5.6 patients in the geriatrics consultation group . There was an even greater reduction in cases of severe delirium , occurring in 7/ 60 ( 12 % ) of intervention patients and 18 / 62 ( 29 % ) of usual-care patients , with a relative risk of 0.40 ( 95 % CI = 0.18 - 0.89 ) . Despite this reduction in delirium , length of stay did not significantly differ between intervention and usual-care groups ( median + /- interquartile range = 5 + /- 2 days in both groups ) , likely because protocol s and pathways predetermined length of stay . In subgroup analyses , geriatrics consultation was most effective in reducing delirium in patients without prefracture dementia or activities of daily living ( ADL ) functional impairment . CONCLUSIONS Proactive geriatrics consultation was successfully implemented with good adherence after hip-fracture repair . Geriatrics consultation reduced delirium by over one-third , and reduced severe delirium by over one-half . Our trial provides strong preliminary evidence that proactive geriatrics consultation may play an important role in the acute hospital management of hip-fracture patients A r and omised controlled trial comparing an accelerated rehabilitation program after proximal femoral fracture with conventional care and rehabilitation was conducted with 252 elderly patients treated at an Australian general hospital in 1989/1990 . This paper presents a cost-effectiveness analysis of the accelerated rehabilitation program . The measure of cost was all direct costs of treatment and subsequent care ( medical and non-medical ) incurred during the 4 months after fracture . Effectiveness was defined as whether the patient returned to semi-independent living ; or if moderately or severely disabled prior to the fracture to the premorbid level of physical independence . The cost for treatment up to 4 months after fracture was estimated at A$ 10,600 per accelerated rehabilitation patient and A$ 12,800 per conventional care patient ( 1990 Australian dollars , A$ ) . Thus , accelerated rehabilitation releases re sources equivalent to approximately 17 % of costs for treatment per patient . When cost effectiveness is considered , the potential cost savings rise to 38 % per recovered patient We tested the hypothesis that since the implementation of the prospect i ve payment system ( PPS ) , elderly patients hospitalized for hip fractures receive shorter , less care-intensive hospitalizations and are more frequently institutionalized . In blinded fashion , we review ed the charts of elderly patients with hip fractures admitted to a municipal hospital from 1981 through 1985 . Demographic and clinical characteristics of patients treated before implementation of the PPS were similar to patients treated thereafter . After implementation of the PPS , the mean length of hospitalization fell from 16.6 to 10.3 days , and the mean number of physical therapy sessions received decreased from 9.7 to 4.9 . Concomitantly , the proportion of patients discharged to a nursing home increased ( 21 % to 48 % ) , as did the proportion receiving nursing home care at six months after discharge ( 13 % to 39 % ) . This increase in long-term nursing home placement suggests that the quality of care for elderly patients with hip fractures may have deteriorated A r and omised controlled trial of two management regimens was carried out in women patients over 65 years of age with hip fractures . Ninety seven patients were admitted to a design ated orthopaedic geriatric unit and 125 to orthopaedic wards . No difference was observed in mortality , length of stay , or placement of patients between the two groups . More medical conditions were recognised and treated in patients in the orthopaedic geriatric unit group . It is concluded that design ated orthopaedic geriatric units can provide medical care to these patients and should be administered without additional cost Orthopaedic geriatric care has become widely accepted despite relatively little formal evaluation . In the East Dorset health authority all patients with fractured neck of femur initially share common orthopaedic facilities but only those from one geographical sector have subsequent access to an orthopaedic geriatric unit , patients from the other sector receiving st and ard care . We have carried out a prospect i ve population -based comparison of the outcome of 155 consecutive incident cases of fractured neck of femur aged over 65 years . On admission to hospital the two population s were similar in respect of age , sex , fracture type , social status , medical and orthopaedic problems , mental status and dependency ( Clifton assessment procedure for the elderly ) . Multiple regression analysis showed that the mean length of stay was 9.5 days shorter in patients from the sector with access to orthopaedic geriatric care ( p less than 0.05 , 95 % confidence interval 0.6 to 18.4 days ) . This reduction was not due to any difference between the two groups as regards dependency or the level of support provided on discharge . There was no difference in outcome at 6 months post-operatively in terms of mortality , functional outcome ( pain and mobility ) , change in dependency or social status . We conclude that in the East Dorset health authority this combined approach has result ed in a significant reduction in the length of inpatient stay without any other apparent effect on patient outcome 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 Objective : To compare hospital and home setting s for the rehabilitation of patients following hip fracture . Design : R and omized controlled trial comparing accelerated discharge and home-based rehabilitation ( n = 34 ) with conventional hospital care ( n = 32 ) for patients admitted to hospital with hip fracture . Setting : Three metropolitan hospitals in Adelaide , Australia . Subjects : Sixty-six patients with fractured hip . Interventions : Patients assigned to the home-based rehabilitation group were discharged within 48 hours of r and omization . The project team therapists made visits to the patient ’s home and negotiated a set of realistic , short-term and measurable treatment goals with both the patient and carer . Those r and omized to usual care remained in hospital for conventional rehabilitation . Main outcome measures : Physical and social dependence , balance con”dence , quality of life , carer strain , patient and carer satisfaction , use of community services and incidence of adverse events such as re-admission and falls . Results : While there was no difference between the groups for all measures of quality of life , patients in the accelerated discharge and home-based rehabilitation group recorded a greater improvement in MBI from r and omization ( p < 0.05 ) and scored higher on the Falls Ef”cacy Scale ( p < 0.05 ) at four months . There was no difference in falls rates . Patients in the home-based rehabilitation group had a shorter stay in hospital ( p < 0.05 ) but a longer stay in rehabilitation overall ( p < 0.001 ) . The groups were comparable on the rate and length of admissions after discharge , use of community services , need for carer input and contact with general practitioner ( GP ) after discharge 1 . Although there are sophisticated surgical procedures for hip fracture repair , a substantial proportion of patients never return to pre-fracture levels of physical function . Factors that influence the recovery of older hip fracture patients represent important areas to study in order to more precisely predict outcome . 2 . Research findings suggest that elevated depressive symptoms and cognitive impairment may negatively affect recovery , while mental alertness , emotional stability , and social involvement positively affect recovery . Thus , hip fracture and its subsequent disability must be studied as a biopsychosocial phenomenon , rather than merely as a physiological event . 3 . Older hip fracture patients may be at higher risk for psychological problems related to the traumatic nature of the injury . A comprehensive psychological assessment at admission can assist the nursing staff to determine which patients are at higher risk for emot
Output:
| There was considerable heterogeneity in length of stay and cost data .
There is a trend to effectiveness when combined outcome variables ( death and institutional care , death and deterioration in function ) are considered . |
MS210968 | ***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: BACKGROUND Important barriers to the wider implementation of shared decision making remain . The experiences of professionals who are skilled in this approach may identify how to overcome these barriers . AIMS To identify the experiences and views of professionals skilled in shared decision making and risk communication , exploring the opportunities and challenges for implementation . DESIGN OF STUDY Qualitative study . SETTING Gwent Health Authority . METHOD Exit interviews using focus group methodology with 20 GPs who had been in practice between 1 and 10 years , and participated in an explanatory trial lasting 6 months . The trial interventions comprised training in shared decision-making skills and the use of risk communication material s. The doctors consulted with up to 48 patients each ( mean = 40 , half of them audiotaped ) for the study . RESULTS The GPs indicated positive attitudes towards involving patients and described positive effects on their consultations . However , the frequency of applying the new skills and tools was limited outside the trial . Doctors were selective about when they felt greater patient involvement was appropriate and feasible , rather than seeking to apply the approaches to the majority of consultations . They felt they often responded to consumer preferences for low levels of involvement in decision making . Time limitations were important in not implementing the approach more widely . CONCLUSION The promotion of ' patient involvement ' appears likely to continue . Professionals appear receptive to this , and willing to acquire the relevant skills . Strategies for wider implementation of patient involvement could address how consultations are scheduled in primary care , and raise consumers ' expectations or desires for involvement OBJECTIVE Fibromyalgia syndrome ( FMS ) is a condition of chronic widespread pain that is difficult to control and is associated with strains in physician-patient interaction . Shared decision making ( SDM ) can be a potential solution to improve interaction . We evaluated the effects of an SDM intervention , including an SDM communication training program for physicians , in a r and omized controlled trial with FMS patients . The main objective was to assess whether SDM improves the quality of physician-patient interaction from patients ' perspective . METHODS Patients were r and omized to either an SDM group or an information-only group . The SDM group was treated by physicians trained in SDM communication and had access to a computer-based information package ; the information-only group received only the information package and was treated by st and ard physicians . All patients were offered the same evidence -based treatment options for FMS . Patients were assessed with question naires on physician-patient interaction ( main outcome criteria ) and decisional processes . Physicians filled out a question naire on interaction difficulties . Assessment took place immediately after the initial consultation . RESULTS Data from 85 FMS patients ( 44 in the SDM group and 41 in the information-only group ) were analyzed . The mean age was 49.9 years ( S.D.=10.2 ) , and 91.8 % of patients were female . The quality of physician-patient interaction was significantly higher in the SDM group than in the information-only group ( P<.001 ) . We found no differences in secondary outcome measures . CONCLUSIONS SDM with FMS patients might be a possible means to achieve a positive quality of physician-patient interaction . A specific SDM communication training program teaches physicians to perform SDM and reduces frustration in patients BACKGROUND AND PURPOSE Shared decision-making ( SDM ) as a model in physician-patient interaction is gaining relevance in the German health system . By applying this model , mid- and long-term improvements are expected especially in the outcomes of chronic diseases . Up to now , there has hardly been any empirical data available in German health services research regarding the state and development of SDM . This study establishes a baseline and provides actual data on this subject based on a German-wide survey of end-stage renal disease ( ESRD ) patients . METHODS St and ardized German-wide survey of 6,614 patients with ESRD . The question naire included an instrument to measure the patients ' perceived involvement in care ( PICS ) which had been translated and vali date d before . RESULTS 82 % of the question ed patients feel their physicians facilitated involvement in decision making . 81 % of the patients actively inform themselves concerning their disease and treatment options . 69 % state that SDM has taken place . Age , years on dialysis and gender correlate with perceived involvement . CONCLUSION This paper provides a valid baseline for the prospect i ve research of SDM in ESRD . The results indicate that dialysis patients are willing to participate in the process of medical decision-making . Characteristics and preferences of the patients should be taken into account not only in everyday clinical interactions . They could be monitored systematic ally within the framework of quality management and used as potential for quality improvement
Output:
| An example of this potential difficulty , from a healthcare provider perspective , is identifying the potential conflict that may develop when a patient 's preference is different from clinical practice guidelines .
Both patients and health care providers have noted improvement in relationships and improved interactions when shared decision-making is in evidence .
Along with this improved relationship and |
MS210969 | ***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: Background —High levels of phobic anxiety have been associated with elevated risks of coronary heart disease ( CHD ) death and sudden cardiac death ( SCD ) among men . To the best of our knowledge , no studies have looked at this association among women . Anxiety may influence CHD mortality by increasing the risk of ventricular arrhythmia and SCD . Methods and Results —We prospect ively examined the relationship between phobic anxiety , as measured by the Crown-Crisp index ( CCI ) , and CHD among women participating in the Nurses ' Health Study . Among 72 359 women with no history of cardiovascular disease or cancer in 1988 , 97 SCDs , 267 CHD deaths , and 930 nonfatal myocardial infa rct ions ( MI ) were documented over 12 years of follow-up . A higher score on the CCI was associated with an increased risk of SCD and fatal CHD but not of nonfatal MI in age-adjusted ( P , trend ≤0.008 ) and in multivariable models excluding possible biological intermediaries ( P , trend ≤0.03 ) . Multivariable adjustment appeared to attenuate the relations ; women who scored 4 or greater on the CCI were at a 1.59-fold ( 95 % CI , 0.97 to 2.60 ) marginally increased risk of SCD and a 1.31-fold ( 95 % CI , 0.97 to 1.75 ) marginally increased risk of fatal CHD compared with those who scored 0 or 1 . After control for possible intermediaries ( hypertension , diabetes , and elevated cholesterol ) , a trend toward an increased risk persisted for SCD ( P=0.06 ) . Conclusions —These prospect i ve data suggest that high levels of phobic anxiety are associated with an increased risk of fatal CHD , particularly from SCD . Some but not all of this risk can be accounted for by CHD risk factors associated with phobic anxiety Background Antipsychotic-induced subjective inner restlessness is one of the common and distressing adverse effects associated with antipsychotics ; however , its underlying neurobiological basis is not well understood . We examined the relationship between antipsychotic-induced subjective inner restlessness and autonomic neurocardiac function . Methods Twenty-two schizophrenia patients with antipsychotic-induced subjective restlessness , 28 schizophrenia patients without antipsychotic-induced subjective restlessness , and 28 matched healthy control subjects were evaluated . Assessment s of the linear and nonlinear complexity measures of heart rate dynamics were performed . Multivariate analysis of variance and correlation analysis were conducted . Results The mean interbeat ( RR ) interval value was significantly higher in control subjects than in patients with and without antipsychotic-induced subjective restlessness ( P < 0.05 ) . The low frequency/high frequency ratio was significantly higher in patients with antipsychotic-induced subjective restlessness than in control subjects and in patients without antipsychotic-induced subjective restlessness ( P < 0.05 ) , while the approximate entropy value was significantly lower in patients with antipsychotic-induced subjective restlessness than in control subjects and in patients without antipsychotic-induced subjective restlessness ( P < 0.05 ) . Correlation analyses controlling for psychotic symptom severity showed that the degree of antipsychotic-induced restlessness had a significant negative correlation with the value of approximate entropy ( P < 0.05 ) . Conclusion The results indicate that antipsychotic-induced subjective restlessness is associated with altered heart rate dynamics parameters , particularly the nonlinear complexity measure , suggesting that it might adversely affect autonomic neurocardiac integrity . Further prospect i ve research is necessary to eluci date the precise interrelationships and causality Background — Cardiac mortality and electrophysiological dysfunction both increase with age . Heart rate variability ( HRV ) provides indices of autonomic function and electrophysiology that are associated with cardiac risk . How habitual physical activity among older adults prospect ively relates to HRV , including nonlinear indices of erratic sinus patterns , is not established . We hypothesized that increasing the levels of both total leisure-time activity and walking would be prospect ively associated with more favorable time-domain , frequency-domain , and nonlinear HRV measures in older adults . Methods and Results — We evaluated serial longitudinal measures of both physical activity and 24-hour Holter HRV over 5 years among 985 older US adults in the community-based Cardiovascular Health Study . After multivariable adjustment , greater total leisure-time activity , walking distance , and walking pace were each prospect ively associated with specific , more favorable HRV indices , including higher 24-hour st and ard deviation of all normal-to-normal intervals ( Ptrend=0.009 , 0.02 , 0.06 , respectively ) and ultralow-frequency power ( Ptrend=0.02 , 0.008 , 0.16 , respectively ) . Greater walking pace was also associated with a higher short-term fractal scaling exponent ( Ptrend=0.003 ) and lower Poincaré ratio ( Ptrend=0.02 ) , markers of less erratic sinus patterns . Conclusions — Greater total leisure-time activity , and walking alone , as well , were prospect ively associated with more favorable and specific indices of autonomic function in older adults , including several suggestive of more normal circadian fluctuations and less erratic sinoatrial firing . Our results suggest potential mechanisms that might contribute to lower cardiovascular mortality with habitual physical activity later in life Background —The predictive value of heart rate variability ( HRV ) in chronic heart failure ( CHF ) has never been tested in a comprehensive multivariate model using short-term laboratory recordings design ed to avoid the confounding effects of respiration and behavioral factors . Methods and Results —A multivariate survival model for the identification of sudden ( presumably arrhythmic ) death was developed with data from 202 consecutive patients referred between 1991 and 1995 with moderate to severe CHF ( age 52±9 years , left ventricular ejection fraction 24±7 % , New York Heart Association class 2.3±0.7 ; the derivation sample ) . Time- and frequency-domain HRV parameters obtained from an 8′ recording of ECG at baseline and during controlled breathing ( 12 to 15 breaths/min ) were challenged against clinical and functional parameters . This model was then vali date d in 242 consecutive patients referred between 1996 and 2001 ( validation sample ) . In the derivation sample , sudden death was independently predicted by a model that included low-frequency power ( LFP ) of HRV during controlled breathing ≤13 ms2 and left ventricular end-diastolic diameter ≥77 mm ( relative risk [ RR ] 3.7 , 95 % CI 1.5 to 9.3 , and RR 2.6 , 95 % CI 1.0 to 6.3 , respectively ) . The derivation model was also a significant predictor in the validation sample ( P = 0.04 ) . In the validation sample , LFP ≤11 ms2 during controlled breathing and ≥83 ventricular premature contractions per hour on Holter monitoring were both independent predictors of sudden death ( RR 3.0 , 95 % CI 1.2 to 7.6 , and RR 3.7 , 95 % CI 1.5 to 9.0 , respectively ) . Conclusions —Reduced short-term LFP during controlled breathing is a powerful predictor of sudden death in patients with CHF that is independent of many other variables . These results refine the identification of patients who may benefit from prophylactic implantation of a cardiac defibrillator OBJECTIVES Cardiac mortality is known to be increased in depressive patients . However , the underlying mechanisms remain elusive to date . Decreased heart rate variability ( HRV ) has been discussed as contributing to increased cardiac mortality , but studies examining patients suffering from major depressive disorder ( MDD ) have revealed inconsistent results . This study aim ed to investigate long-term and broad b and parameters of heart rate regulation in MDD , which have been shown to be more sensitive for the assessment of autonomic dysfunction . METHODS A total of 18 non-medicated patients suffering from MDD and 18 matched control subjects without cardiac disease were recruited and 24-h ambulatory electrocardiograms were recorded . Data were recorded during three distinct time intervals linear and nonlinear parameters as well as autonomic information flow ( AIF ) were calculated . RESULTS The power law slope was significantly reduced in the patient group for all intervals investigated and correlated with symptom severity , whereas st and ard deviation of the 5-min NN intervals ( SDANN ) and area under the AIF curve ( INT(NN ) ) showed significant differences between groups in the morning hours only . Analysis of st and ard HRV parameters in the time and frequency domain revealed no significant differences between groups . CONCLUSIONS The evidence for decreased complexity of cardiac regulation in depressed patients presented here might be useful as an indicator of the increased cardiac mortality known in depression , especially since these parameters are capable of predicting cardiac mortality in other diseases . The importance of these parameters for patients at risk should be evaluated in future prospect i ve studies BACKGROUND Several studies have suggested an increased risk of fatal coronary heart disease ( CHD ) among patients with panic disorder , phobic anxiety , and other anxiety disorders . We prospect ively examined this association in the Normative Aging Study . METHODS AND RESULTS An anxiety symptoms scale was constructed out of five items from the Cornell Medical Index , which was administered to the cohort at baseline . During 32 years of follow-up , we observed 402 cases of incident coronary heart disease ( 137 cases of nonfatal myocardial infa rct ion , 134 cases of angina pectoris , and 131 cases of fatal CHD : made up of 26 cases of sudden cardiac death and 105 cases of nonsudden death ) . A nested case-control design ( involving 1869 control subjects who remained free of diagnosed CHD ) was used to assess the association between anxiety and risk of CHD . Compared with men reporting no symptoms of anxiety , men reporting two or more anxiety symptoms had elevated risks of fatal CHD ( age-adjusted odds ratio [ OR ] = 3.20 , 95 % confidence interval [ CI ] : 1.27 to 8.09 ) , and sudden death ( age-adjusted OR = 5.73 , 95 % CI : 1.26 to 26.1 ) . The multivariate OR after adjusting for a range of potential confounding variables was 1.94 ( 95 % CI : 0.70 - 5.41 ) for fatal CHD and 4.46 ( 95 % CI : 0.92 - 21.6 ) for sudden death . No excess risks were found for nonfatal myocardial infa rct ion or angina . CONCLUSIONS These data suggest an association between anxiety and fatal coronary heart disease , in particular , sudden cardiac death BACKGROUND Low heart rate variability has been implicated as a risk factor for sudden death . However , no large epidemiological studies using sudden death as an outcome event have been reported . METHODS AND RESULTS A total of 6,693 consecutive patients who underwent 24-hour ambulatory ECG were followed up for 2 years ; of these , 245 patients died suddenly . Clinical data at the time of 24-hour ambulatory ECG were collected for all patients who died suddenly and for a r and om sample of 268 patients from the study cohort . In all patients in sinus rhythm with or without occasional supraventricular arrhythmias at the 24-hour ECG ( 193 patients who died suddenly and 230 patients from the sample ) , heart rate variability parameters were derived . Patients with low short-term RR interval variability ( mean during 24 hours of per-minute st and ard deviations [ SD ] of RR intervals < 25 msec ) had a 4.1-fold higher risk ( 95 % confidence interval [ CI ] , 2.6 , 8.1 ) for sudden death than patients with high short-term variability ( > or = 40 msec ) ; after adjustment for age , evidence of cardiac dysfunction , and history of myocardial infa rct ion , the relative risk was 2.6 ( 95 % CI , 1.4 , 5.1 ) . The crude relative risk of long-term RR interval variability ( SD during 24 hours of per-minute means of RR intervals < 8 msec ) was 4.4 ( 95 % CI , 2.6 , 7.7 ) ; after adjustment for the same risk factors , it was 2.2 ( 95 % CI , 1.2 , 4.1 ) . Patients with a minimum heart rate > or = 65 beats per minute had a double risk of sudden death compared with those with a minimum heart rate < 65 beats per minute ( adjusted relative risk , 2.1 ; 95 % CI , 1.3 , 3.6 ) . CONCLUSIONS These findings support the theory that patients with low parasympathetic activity ( low short-term RR interval variability ) have an increased risk for sudden death independent of other risk factors OBJECTIVES Alarming somatic symptoms and in particular the cardiovascular symptoms , are the characteristic features of panic attacks . Increased cardiac mortality and morbidity have been proposed in these patients . Power spectral analysis of electrocardiogram R-R intervals is known to be a particularly successful tool in the detection of autonomic instabilities in various clinical disorders . Heart rate variability ( HRV ) has been found to be the outcome of rapidly reacting cardiovascular control systems . The aim of our study is to measure very low frequency b and ( VLF ) , low frequency b and ( LF ) and high frequency b and ( HF ) components of R-R interval during orthostatic experiment in patients with panic disorder before and after treatment and compares it with healthy
Output:
| Effect sizes remained highly significant for medication-free patients compared to controls across all disorders .
Smaller and significant reductions in HRV were observed for specific antidepressants and antipsychotics .
Combined findings confirm substantial reductions in HRV across psychiatric disorders , and these effects remained significant even in medication-free individuals .
Reductions in HRV may therefore represent a significant mechanism contributing to elevated cardiovascular risk in individuals with psychiatric disorders . |
MS210970 | ***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: AIMS There are limited contemporary data on the presentation , management , and outcomes of acute coronary syndrome ( ACS ) admissions in India . We aim ed to develop a prospect i ve registry to address treatment and health systems gaps in the management of ACSs in Kerala , India . METHODS AND RESULTS We prospect ively collected data on 25 748 consecutive ACS admissions from 2007 to 2009 in 125 hospitals in Kerala . We evaluated data on presentation , management , and in-hospital mortality and major adverse cardiovascular events ( MACE ) . We created r and om-effects multivariate regression models to evaluate predictors of outcomes while accounting for confounders . Mean ( SD ) age at presentation was 60 ( 12 ) years and did not differ among ACS types [ ST-segment myocardial infa rct ion ( STEMI ) = 37 % ; non-STEMI = 31 % ; unstable angina = 32 % ] . In-hospital anti-platelet use was high ( > 90 % ) . Thrombolytics were used in 41 % of STEMI , 19 % of non-STEMI , and 11 % of unstable angina admissions . Percutaneous coronary intervention rates were marginally higher in STEMI admissions . Discharge medication rates were variable and generally suboptimal ( < 80 % ) . In-hospital mortality and MACE rates were highest for STEMI ( 8.2 and 10.3 % , respectively ) . After adjustment , STEMI diagnosis ( vs. unstable angina ) [ odds ratio ( OR ) ( 95 % confidence interval = 4.06 ( 2.36 , 7.00 ) ] , symptom-to-door time > 6 h [ OR = 2.29 ( 1.73 , 3.02 ) ] , and inappropriate use of thrombolysis [ OR = 1.33 ( 0.92 , 1.91 ) ] were associated with higher risk of in-hospital mortality and door-to-needle time < 30 min [ OR = 0.44 ( 0.27 , 0.72 ) ] was associated with lower mortality . Similar trends were seen for risk of MACE . CONCLUSION These data represent the largest ACS registry in India and demonstrate opportunities for improving ACS care Background —Organizational and wider health system factors influence the implementation and success of interventions . Clinical Pathways in Acute Coronary Syndromes 2 is a cluster r and omized trial of a clinical pathway – based intervention to improve acute coronary syndrome care in hospitals in China . We performed a qualitative evaluation to examine the system-level barriers to implementing clinical pathways in the dynamic healthcare environment of China . Methods and Results —A qualitative descriptive analysis of 40 in-depth interviews with health professionals conducted in a sample of 10 hospitals purposively selected to explore barriers to implementation of the intervention . Qualitative data were analyzed using the Framework method . In-depth interviews identified 5 key system-level barriers to effective implementation : ( 1 ) leadership support for implementing quality improvement , ( 2 ) variation in the capacity of clinical services and quality improvement re sources , ( 3 ) fears of patient disputes and litigation , ( 4 ) healthcare funding constraints and high out-of-pocket expenses , and ( 5 ) patient-related factors . Conclusions —System-level barriers affect the ability of acute coronary syndrome clinical pathways to change practice . Addressing these barriers in the context of current and planned national health system reform will be critical for future improvements in the management of acute coronary syndromes , and potentially other hospitalized conditions , in China . Clinical Trial Registration —URL : http://www.anzctr.org.au/default.aspx . Register . Unique identifier : ACTRN12609000491268 BACKGROUND Acute coronary syndromes ( ACSs ) are a major cause of morbidity and mortality , yet effective ACS treatments are frequently underused in clinical practice . R and omized trials including the CPACS-2 study suggest that quality improvement initiatives can increase the use of effective treatments , but whether such programs can impact hard clinical outcomes has never been demonstrated in a well-powered r and omized controlled trial . DESIGN The CPACS-3 study is a stepped-wedge cluster-r and omized trial conducted in 104 remote level 2 hospitals without PCI facilities in China . All hospitalized ACS patients will be recruited consecutively over a 30-month period to an anticipated total study population of more than 25,000 patients . After a 6-month baseline period , hospitals will be r and omized to 1 of 4 groups , and a 6-component quality improvement intervention will be implemented sequentially in each group every 6months . These components include the following : establishment of a quality improvement team , implementation of a clinical pathway , training of physicians and nurses , hospital performance audit and feedback , online technical support , and patient education . All patients will be followed up for 6months postdischarge . The primary outcome will be the incidence of in-hospital major adverse cardiovascular events comprising all-cause mortality , myocardial infa rct ion or reinfa rct ion , and nonfatal stroke . CONCLUSIONS The CPACS-3 study will be the first large r and omized trial with sufficient power to assess the effects of a multifaceted quality of care improvement initiative on hard clinical outcomes , in patients with ACS Background —Substantial evidence - practice gaps exist in the management of acute coronary syndromes ( ACS ) in China . Clinical pathways are tools for improving ACS quality of care but have not been rigorously evaluated . Methods and Results —Between October 2007 and August 2010 , a quality improvement program was conducted in 75 hospitals throughout China with mixed methods evaluation in a cluster r and omized , controlled trial . Eligible hospitals were level 2 or level 3 centers routinely admitting > 100 patients with ACS per year . Hospitals were assigned immediate implementation of the American Heart Association/American College of Cardiology guideline based clinical pathways or commencement of the intervention 12 months later . Outcomes were several key performance indicators reflecting the management of ACS . The key performance indicators were measured 12 months after commencement in intervention hospitals and compared with baseline data in control hospitals , using data collected from 50 consecutive patients in each hospital . Pathway implementation was associated with an increased proportion of patients discharged on appropriate medical therapy , with nonsignificant improvements or absence of effects on other key performance indicators . Conclusions —Among hospitals in China , the use of a clinical pathway for the treatment of ACS compared with usual care improved secondary prevention treatments , but effectiveness was otherwise limited . An accompanying process evaluation identified several health system barriers to more successful implementation . Clinical Trial Registration —URL : http://www.anzctr.org.au/default.aspx . Unique identifier : ACTRN12609000491268 CONTEXT Studies have found that patients with acute coronary syndromes ( ACS ) often do not receive evidence -based therapies in community practice . This is particularly true in low- and middle-income countries . OBJECTIVE To evaluate whether a multifaceted quality improvement ( QI ) intervention can improve the use of evidence -based therapies and reduce the incidence of major cardiovascular events among patients with ACS in a middle-income country . DESIGN , SETTING , AND PARTICIPANTS The BRIDGE-ACS ( Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes ) trial , a cluster-r and omized ( concealed allocation ) trial conducted among 34 clusters ( public hospitals ) in Brazil and enrolling a total of 1150 patients with ACS from March 15 , 2011 , through November 2 , 2011 , with follow-up through January 27 , 2012 . INTERVENTION Multifaceted QI intervention including educational material s for clinicians , reminders , algorithms , and case manager training , vs routine practice ( control ) . MAIN OUTCOME MEASURES Primary end point was the percentage of eligible patients who received all evidence -based therapies ( aspirin , clopidogrel , anticoagulants , and statins ) during the first 24 hours in patients without contraindications . RESULTS Mean age of the patients enrolled was 62 ( SD , 13 ) years ; 68.6 % were men , and 40 % presented with ST-segment elevation myocardial infa rct ion , 35.6 % with non-ST-segment elevation myocardial infa rct ion , and 23.6 % with unstable angina . The r and omized clusters included 79.5 % teaching hospitals , all from major urban areas and 41.2 % with 24-hour percutaneous coronary intervention capabilities . Among eligible patients ( 923/1150 [ 80.3 % ] ) , 67.9 % in the intervention vs 49.5 % in the control group received all eligible acute therapies ( population average odds ratio [ OR(PA ) ] , 2.64 [ 95 % CI , 1.28 - 5.45 ] ) . Similarly , among eligible patients ( 801/1150 [ 69.7 % ] ) , those in the intervention group were more likely to receive all eligible acute and discharge medications ( 50.9 % vs 31.9 % ; OR(PA ) , , 2.49 [ 95 % CI , 1.08 - 5.74 ] ) . Overall composite adherence scores were higher in the intervention clusters ( 89 % vs 81.4 % ; mean difference , 8.6 % [ 95 % CI , 2.2%-15.0 % ] ) . In-hospital cardiovascular event rates were 5.5 % in the intervention group vs 7.0 % in the control group ( OR(PA ) , 0.72 [ 95 % CI , 0.36 - 1.43 ] ) ; 30-day all-cause mortality was 7.0 % vs 8.4 % ( ORPA , 0.79 [ 95 % CI , 0.46 - 1.34 ] ) . CONCLUSION Among patients with ACS treated in Brazil , a multifaceted educational intervention result ed in significant improvement in the use of evidence -based therapies . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00958958 & NA ; Ischemic heart disease is the leading cause of death in India , and there are likely more myocardial infa rct ions in India than in any other country in the world . We have previously reported heterogeneous care for patients with myocardial infa rct ion in Kerala , a state in southern India , including both gaps in optimal care and inappropriate care . Based on that prior work , limitations from previous nonr and omized quality improvement studies and promising gains in process of care measures demonstrated from previous r and omized trials , we and the Cardiological Society of India — Kerala chapter sought to develop , implement , and evaluate a quality improvement intervention to improve process of care measures and clinical outcomes for these patients . In this article , we report the rationale and study design for the ACS QUIK cluster‐r and omized stepped‐wedge clinical trial ( NCT02256657 ) in which we aim to enroll 15,750 participants with acute coronary syndromes across 63 hospitals . To date , most participants are men ( 76 % ) and have ST‐segment elevation myocardial infa rct ion ( 63 % ) . The primary outcome is 30‐day major adverse cardiovascular events defined as death , recurrent infa rct ion , stroke , or major bleeding . Our secondary outcomes include health‐related quality of life and individual‐ and household‐level costs . We also describe the principal features and limitations of the stepped‐wedge study design , which may be important for other investigators or sponsors considering cluster‐r and omized stepped‐wedge trials Background The burden of cardiovascular diseases ( CVDs ) remains unclear in many regions of the world . Objectives The GBD ( Global Burden of Disease ) 2015 study integrated data on disease incidence , prevalence , and mortality to produce consistent , up-to- date estimates for cardiovascular burden . Methods CVD mortality was estimated from vital registration and verbal autopsy data . CVD prevalence was estimated using modeling software and data from health surveys , prospect i ve cohorts , health system administrative data , and registries . Years lived with disability ( YLD ) were estimated by multiplying prevalence by disability weights . Years of life lost ( YLL ) were estimated by multiplying age-specific CVD deaths by a reference life expectancy . A sociodemographic index ( SDI ) was created for each location based on income per capita , educational attainment , and fertility . Results In 2015 , there were an estimated 422.7 million cases of CVD ( 95 % uncertainty interval : 415.53 to 427.87 million cases ) and 17.92 million CVD deaths ( 95 % uncertainty interval : 17.59 to 18.28 million CVD deaths ) . Declines in the age-st and ardized CVD death rate occurred between 1990 and 2015 in all high-income and some middle-income countries . Ischemic heart disease was the leading cause of CVD health lost globally , as well as in each world region , followed by stroke . As SDI increased beyond 0.25 , the highest CVD mortality shifted from women to men . CVD mortality decreased sharply for both sexes in countries with an SDI > 0.75 . Conclusions CVDs remain a major cause of health loss for all regions of the world . Sociodemographic change over the past 25 years has been associated with dramatic declines in CVD in regions with very high SDI ,
Output:
| Barriers that influenced the implementation or acceptability of the toolkit intervention for physicians included time and staff constraints , Internet access , patient volume , and inadequate underst and ing of the quality improvement toolkit intervention . |
MS210971 | ***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 multicenter phase II Japanese Gynecologic Oncology Group study ( JGOG1067 ) was design ed to evaluate the efficacy and safety of postoperative chemotherapy in patients with node-positive cervical cancer . METHODS Patients with stage IB-IIA squamous cervical cancer who underwent radical hysterectomy and were confirmed to have pelvic lymph node metastasis were eligible for this study . The patients postoperatively received irinotecan ( CPT-11 ; 60mg/m2 intravenously on days 1 and 8) and nedaplatin ( NDP ; 80mg/m2 intravenously on day 1 ) . Chemotherapy administration commenced within 6weeks after surgery and was repeated every 28days for up to 5cycles . The primary endpoint of this study was the 2-year recurrence-free survival ( RFS ) rate . The secondary endpoints were the 5-year overall survival ( OS ) rate , 5-year RFS rate , and adverse events such as complications of chemotherapy and lower-limb edema . RESULTS Sixty-two patients were analyzed according to our protocol , among whom 55 ( 88.7 % ) completed 5cycles of scheduled treatment . The median follow-up period was 66.1months ( range , 16.8 - 96.6months ) . The 2-year and 5-year RFS rates were 87.1 % ( 95 % confidence interval [ CI ] : 75.9 - 99.3 ) and 77.2 % ( 95 % CI : 64.5 - 85.8 ) , respectively . Fourteen patients ( 22.5 % ) experienced recurrence during the follow-up period , 8 of whom died of the disease . The 5-year OS rate in this study was 86.5 % ( 95 % CI : 74.8 - 93.0 ) . Only 9.7 % of the patients experienced lymphedema in their legs . CONCLUSION Postoperative chemotherapy without radiotherapy was found to be very effective in high-risk patients with node-positive cervical cancer BACKGROUND To evaluate the efficacy of a miniaturized portable transcutaneous electrical nerve stimulation ( TENS ) unit ( ReliefB and ) as an adjunct to st and ard antiemetic therapy for controlling nausea and vomiting induced by cisplatin-based chemotherapy in gynecologic oncology patients . METHODS Forty-two patients were enrolled in a r and omized , double-blind , placebo-controlled parallel-subjects trial with a follow-up crossover trial . All patients received a st and ardized antiemetic protocol , then wore the ReliefB and continuously for 7 days . RESULTS Thirty-two patients were evaluable for the parallel-subjects component , 16 in each group . The percentage of patients with absent or minimal nausea was 59 % overall , which was similar to that for both the active ( 56 % ) and placebo ( 62 % ) groups . The incidence and severity of nausea and vomiting was similar for each group . Eighteen patients completed two consecutive cycles and were evaluable for the crossover component . The average age of the crossover patients and their dose intensity were comparable with those of the overall study population ( 56.3 versus 58.6 years and 22.7 versus 22.7 mg/m2/week , respectively ) . The percentage of cycles with absent or minimal nausea was 47 % overall , which was similar to that of the active ( 50 % ) and placebo ( 44 % ) cycles . However , the severity of nausea was significantly lower in the active cycles during days 2 to 4 . Patients averaged less than one episode of vomiting daily in each cycle . CONCLUSIONS The ReliefB and is an effective adjunct to st and ard antiemetic agents for controlling nausea induced by cisplatin-based chemotherapy in gynecologic oncology patients OBJECTIVES . The aim of this study was to compare 4 versus 6 courses of adjuvant chemotherapy after neoadjuvant chemotherapy plus radical surgery in terms of overall survival ( OS ) , disease-free survival ( DFS ) , recurrence rate and toxicity profile . METHODS . We r and omly assigned 200 patients with IB2-IIB cervical cancer to receive 4 ( Group A ) or 6 ( Group B ) courses of cisplatin 100 mg/mq and paclitaxel 175 mg/mq every 21 days . RESULTS . At 4-years follow-up , the comparison of recurrence rate ( p = 1 ; RR = 1.005 ; 95 % CI = 0.87 to 1.161 ) , OS ( p = 0.906 ) and DFS ( p = 0.825 ) did not show statistically significant differences between the two groups . Data analysis showed statistically significant differences between the two groups in term of episodes of leukopenia ( p = 0.0072 ; RR = 1.513 ; 95 % CI = 1.127 - 2.03 ) , anemia ( p = 0.048 ; RR = 1.188 ; CI = 1.012 - 1.395 ) and febrile neutropenia ( p = 0.042 ; RR = 1.119 ; 95 % CI = 1.014 - 1.235 ) , in favor of Group A. As regards non-hematological toxicities , there were no statistically significant differences in terms of gastrointestinal symptoms ( p = 0.49 ; RR = 1.046 ; CI = 0.948 - 1.153 . On the contrary , there was a statistically significant difference regarding neurological symptoms ( p=0.014 ; RR=1.208 ; CI=1.046 - 1.395 ) , that were less frequent in Group A ( 13 % ) than in Group B ( 28 % ) . CONCLUSIONS . Adjuvant treatment with 4 or 6 courses of platinum-based chemotherapy showed similar results in terms of OS and DSF , with a favorable toxicity profile in favor of the first regimen CONTEXT Chemotherapy-induced peripheral neuropathy ( CIPN ) is a major dose-limiting and persistent consequence of numerous classes of antineoplastic agents , affecting up to 30%-40 % of patients . To date , there is no effective prevention or therapy . An evolving hypothesis for reducing CIPN pain involves direct nerve stimulation to reduce the pain impulse . OBJECTIVES To evaluate the impact on CIPN associated with the MC5-A Calmare ® therapy device . METHODS The MC5-A Calmare ® therapy device is design ed to generate a patient-specific cutaneous electrostimulation to reduce the abnormal pain intensity . Sixteen patients from one center received one-hour interventions daily over 10 working days . RESULTS Of 18 patients , 16 were evaluable . The mean age of the patients was 58.6 years-four men and 14 women- and the duration of CIPN was three months to eight years . The most common drugs were taxanes , platinums , and bortezomib ( Velcade , Millenium Pharmaceuticals , Cambridge MA ) . At the end of the study ( Day 10 ) , a 20 % reduction in numeric pain scores was achieved in 15 of 16 patients . The pain score fell 59 % from 5.81±1.11 before treatment to 2.38±1.82 at the end of 10 days ( P<0.0001 by paired t-test ) . A daily treatment benefit was seen with a strong statistically significant difference between the pre- and post-daily pain scores ( P<0.001 ) . Four patients had their CIPN reduced to zero . A repeated- measures analysis using the scores from all 10 days confirmed these results . No toxicity was seen . Some responses have been durable without maintenance . CONCLUSION Patient-specific cutaneous electrostimulation with the MC5-A Calmare ® device appears to dramatically reduce pain in refractory CIPN patients with no toxicity . Further studies are underway to define the benefit , mechanisms of action , and optimal schedule Background Many patients experience nausea and vomiting during chemotherapy treatment . Evidence demonstrates that electroacupuncture is beneficial for controlling chemotherapy-induced nausea and vomiting ( CINV ) . However , the acupoint or matching acupoint with the best efficacy for controlling CINV still remains unidentified . Methods / Design This study consists of a r and omized controlled trial ( RCT ) with four parallel arms : a control group and three electroacupuncture groups ( one with Neiguan ( PC6 ) , one with Zhongwan ( CV12 ) , and one with both PC6 and CV12 ) . The control group received st and ard antiemetic only , while the other three groups received electroacupuncture stimulation with different acupoints besides the st and ard antiemetic . The intervention is done once daily from the first day ( day 1 ) to the fourth day ( day 4 ) during chemotherapy treatment . The primary outcome measures include frequency of nausea , vomiting and retching . The secondary outcome measures are the grade of constipation and diarrhea , electrogastrogram , assessment of quality of life , assessment of anxiety and depression , and other adverse effects during the chemotherapy . Assessment s are scheduled from one day pre-chemotherapy ( day 0 ) to the fifth day of chemotherapy ( day 5 ) . Follow-ups are done from day 6 to day 21 . Discussion The aim of this study is to evaluate the efficacy and safety of electro-acupuncture with different acupoints in the management of CINV.Trial registration The register number of r and omized controlled trial is NCT02195908 . The date of registration was 21 July 2014 PURPOSE The aim of this Phase II , non-r and omized study was to assess activity and safety of neoadjuvant chemotherapy ( NACT ) before chemoradiation ( CT/RT ) followed by radical surgery ( RS ) in locally advanced cervical cancer ( LACC ) patients . METHODS AND MATERIAL S The primary end point was rate of pathologic complete response ( pCR ) . FIGO Stage IB2-IVA patients were administered NACT chemotherapy ( paclitaxel 80 mg/m2 , carboplatin AUC 2 ) , for 6 weeks , followed by Intensity Modulated Radiotherapy plus simultaneous boost ( total dose of 50.4 Gy to CTV1 , and 39.6 Gy to CTV2 ) . Clinical response was assessed according to RECIST criteria . Responsive patients were triaged to RS . The regimen would be considered active if > 20 pCRs were registered in 39 patients . RESULTS 45 patients were enrolled into the study ; 25 patients ( 55.5 % ) were FIGO stage IIB , 9 cases ( 20.0 % ) had stage III disease . At work up , pelvic lymph node involvement was documented in 38 ( 84.4 % ) patients ; pCR was documented in 18 out of 40 patients ( 45.0 % ) . Grade 3 - 4 hematological toxicity after NACT occurred in 4 patients ; CT/RT associated grade 3 toxicity was found in 7 patients . Early and late postoperative complications were detected in 16 , and 11 cases , respectively . Three-year PFS and OS were 66.0 % and 86.0 % , respectively . CONCLUSIONS NACT followed by CT/RT by IMRT and RS , is feasible and safe ; failure to achieve the primary endpoint has to be recognized ; however , enrollment of a higher rate of poor prognosis patients compared to historical data used to calculate sample size , could have result ed in reduced activity A prospect i ve phase 2 study was conducted to evaluate the clinical utility of acupuncture-like transcutaneous nerve stimulation ( ALTENS ) for the treatment of chemotherapy-induced peripheral neuropathy ( CIPN ) . Eligible cancer patients had a < 2 ECOG performance score , received neurotoxic chemotherapy , and developed CIPN symptoms for > two months . R and omization was used to eliminate bias in patient selection for ALTENS and was not to compare the effectiveness between the two treatments . ALTENS treatments were delivered using Codetron units . Bilateral acupuncture points included LI4 and LIV3 , plus LI11 or ST36 were stimulated . Acupuncture treatments were administered to CV6 , SP6 , ST6 , LI11 , Bafeng , Baxie and selective Jing points bilaterally . Twelve treatments were delivered twice weekly over 6 to 8 weeks . The Modified Total Neuropathy Score ( mTNS ) , Numbness Score , and Edmonton Symptom Assessment Score ( ESAS ) were assessed at baseline , treatment completion , plus at 3 and 6 months follow-up . The primary study endpoint was mTNS score at 6 months . We planned to recruit 23 patients into each group . After 30 patients were recruited , 2 were lost to follow-up at 3 months in the ALTENS group and 3 in the acupuncture group . The research team decided to recruit all remaining consecutive patients only to the ALTENS group to ensure an adequate evaluation of ALTENS , the primary object of evaluation . There were 27 patients in the ALTENS group , with an average symptom duration of 10 months after chemotherapy . Twenty four and 23 patients completed the 3 and 6 month follow-up respectively . The median mTNS scores were 7.1 , 4.0 , 3.6 and 3.1 at baseline , treatment completion , 3 and 6 months follow-up , respectively . One-way ANOVA analysis showed a significant improvement in mTNS scores ( p
Output:
| Results : This systematic review will assess the effectiveness of ES on AEs caused by chemotherapy in patients with CC .
Conclusion : The findings of this study may summarize the latest evidence for the ES on AEs following chemotherapy for CC . |
MS210972 | ***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 Beneficial effects of hypertonic saline on lung function in cystic fibrosis patients are well documented . However , the effects of various concentrations of hypertonic saline are not well studied . We , therefore , compared the effects of 3 and 7 % hypertonic saline administered by nebulization on lung function in children with cystic fibrosis . METHOD In a double-blind r and omized controlled trial , 31 children with cystic fibrosis were r and omized to receive either 3 % saline or 7 % saline nebulization twice daily for 28 days . Spirometry was performed and functional status was measured on Day 14 and 28 . RESULTS Of 31 children enrolled in the study , 30 completed the 28 days follow up ( 15 in each group ) . Percentage change in Forced Expiratory Volume during first second ( FEV(1 ) ) from baseline to Day 14 and on Day 28 was significantly higher in the group receiving 3 % saline as compared with those receiving 7 % saline inhalation . There was some decrease in FEV(1 ) ( percentage predicted ) immediately after 7 % saline inhalation unlike 3 % saline . The functional status remained comparable between the two groups . CONCLUSION The results suggest that 3 % hypertonic saline nebulization was better than 7 % saline inhalation . There is a need for studies with larger sample size and longer duration to confirm our results Background The mucoactive effects of hypertonic saline should promote exacerbation resolution in people with cystic fibrosis ( CF ) . Objectives To determine the effects of hypertonic saline inhalation during hospitalisation for exacerbation of CF on length of stay , lung function , symptoms , oxygenation , exercise tolerance , quality of life , bacterial load and time to next hospitalisation . Methods 132 adults with an exacerbation of CF were r and omised to inhale three nebulised doses a day of either 4 mL 7 % saline or a taste-masked control of 0.12 % saline , throughout the hospital admission . The primary outcome measure was length of hospital stay . Results All participants tolerated their allocated saline solution . There was no significant difference in length of stay , which was 12 days in the hypertonic saline group and 13 days in controls , with a mean between-group difference ( MD ) of 1 day ( 95 % CI 0 to 2 ) . The likelihood of regaining pre-exacerbation FEV1 by discharge was significantly higher in the hypertonic saline group ( 75 % vs 57 % ) , and the number needed to treat was 6 ( 95 % CI 3 to 65 ) . On a 0–100 scale , the hypertonic saline group had significantly greater reduction in symptom severity than the control group at discharge in sleep ( MD=13 , 95 % CI 4 to 23 ) , congestion ( MD=10 , 95 % CI 3 to 18 ) and dyspnoea ( MD=8 , 95 % CI 1 to 16 ) . No significant difference in time to next hospitalisation for a pulmonary exacerbation was detected between groups ( HR=0.86 ( CI 0.57 to 1.30 ) , p=0.13 ) . Other outcomes did not significantly differ . Conclusions Addition of hypertonic saline to the management of a CF exacerbation did not reduce the length of hospital stay . Hypertonic saline speeds the resolution of exacerbation symptoms and allows patients to leave hospital with greater symptom resolution . Trial registration number ACTRN12605000780651 Our goal was to assess the role of early childhood vaccination in the occurrence of respiratory symptoms and allergic sensitization in 7 - 8-year-old Dutch and German children . A nested case-control study was conducted among children participating in a large longitudinal study on respiratory health , to study the relationship between vaccination ( bacille Calmette-Guérin ( BCG ) , pertussis , measles/mumps , rubella , and Haemophilus influenza type b ( Hib ) ) and respiratory symptoms and allergic sensitization . Parents of 510 7 - 8-year-old children with respiratory complaints and an equal number of r and omly selected children without respiratory complaints were asked to complete a question naire . Blood sample s were collected for specific serum IgE analysis . Vaccination status was assessed through the records of the participating Municipal Health Services . No association between vaccination against pertussis , measles , rubella , or Hib and respiratory symptoms or allergic sensitization was found . For sensitization against house dust mite , BCG vaccination result ed in an increased risk ( OR , 2.28 ; 95 % CI , 1.05 - 4.96 ) . Birth order was inversely associated with allergic sensitization , but was not related to respiratory symptoms . We found an association between BCG vaccination and the subsequent risk for sensitization against house dust mite . No evidence was found for an association between vaccination and respiratory symptoms . Earlier reports of an association of birth order with atopic disease were supported by the results of the present study BACKGROUND Chronic rhinosinusitis is a hallmark of Cystic fibrosis ( CF ) impairing the patients ' quality of life and overall health . However , therapeutic options have not been sufficiently evaluated . Bronchial inhalation of mucolytic substances is a gold st and ard in CF therapy . Previously , we found that sinonasal inhalation of dornase alfa as vibrating aerosol reduces symptoms of chronic rhinosinusitis more effectively than NaCl 0.9 % ( net treatment benefit : -5.87±2.3 points , p=0.017 ; SNOT-20 total score ) . This multicenter study compares the effect of NaCl 6.0 % vs. NaCl 0.9 % following the protocol from our preceding study with dornase alfa . METHODS Sixty nine CF patients with chronic rhinosinusitis in eleven German CF centers were r and omized to receive sinonasal vibrating inhalation of either NaCl 6.0 % or NaCl 0.9 % for 28days . After 28days of wash-out , patients crossed over to the alternative treatment . The primary outcome parameter was symptom score in the disease-specific quality of life Sino-Nasal Outcome Test-20 ( SNOT-20 ) . Additionally , pulmonary function was assessed , as well as rhinomanometry and inflammatory markers in nasal lavage ( neutrophil elastase , interleukin (IL)-1β , IL-6 , and IL-8 ) in a subgroup . RESULTS Both therapeutic arms were well tolerated and showed slight improvements in SNOT-20 total scores ( NaCl 6.0 % : -3.1±6.5 points , NaCl 0.9 % : -5.1±8.3 points , ns ) . In both treatment groups , changes of inflammatory parameters in nasal lavage from day 1 to day 29 were not significant . We suppose that the irritating properties of NaCl 6.0 % reduced the suitability of the SNOT-20 scores as an outcome parameter . Alternative primary outcome parameters such as MR-imaging or the quantity of sinonasal secretions mobilized with both saline concentrations were , however , not feasible . CONCLUSION Sinonasal inhalation with NaCl 6.0 % did not lead to superior results vs. NaCl 0.9 % , whereas dornase alfa had been significantly more effective than NaCl 0.9 % Background Streamlining the timing of treatments in cystic fibrosis ( CF ) is important to optimise adherence while ensuring efficacy . The optimal timing of treatment with hypertonic saline ( HTS ) and airway clearance techniques ( ACT ) is unknown . Objectives This study hypothesised that HTS before ACT would be more effective than HTS during ACT as measured by Lung Clearance Index ( LCI ) . Methods Adults with CF providing written informed consent were r and omised to a crossover trial of HTS before ACT or HTS during ACT on consecutive days . ACT treatment consisted of Acapella Duet . Patients completed LCI and spirometry at baseline and 90 min post treatment . Mean difference ( MD ) and 95 % CIs were reported . Results 13 subjects completed the study ( mean ( SD ) age 33 ( 12 ) years , forced expiratory volume in 1second % ( FEV1 % ) predicted 51 % ( 22 ) , LCI ( no. turnovers ) 14 ( 4 ) ) . Comparing the two treatments ( HTS before ACT vs HTS during ACT ) , the change from baseline to 90 min post treatment in LCI ( MD ( 95 % CI ) −0.02 ( −0.63 to 0.59 ) ) and FEV1 % predicted ( MD ( 95 % CI ) −0.25 ( −2.50 to 1.99 ) ) was not significant . There was no difference in sputum weight ( MD ( 95 % CI ) −3.0 ( −14.9 to 8.9 ) ) , patient perceived ease of clearance ( MD ( 95 % CI ) 0.4 ( −0.6 to 1.3 ) or satisfaction ( MD ( 95 % CI ) 0.4 ( −0.6 to 1.5 ) ) . The time taken for HTS during ACT was significantly shorter ( MD ( 95 % CI ) 14.7 ( 9.8 to 19.6 ) ) . Conclusions In this pilot study , HTS before ACT was no more effective than HTS during ACT as measured by LCI . Trial registration number NCT01753869 ; Pre- results BACKGROUND Inhaled hypertonic saline acutely increases mucociliary clearance and , in short-term trials , improves lung function in people with cystic fibrosis . We tested the safety and efficacy of inhaled hypertonic saline in a long-term trial . METHODS In this double-blind , parallel-group trial , 164 patients with stable cystic fibrosis who were at least six years old were r and omly assigned to inhale 4 ml of either 7 percent hypertonic saline or 0.9 percent ( control ) saline twice daily for 48 weeks , with quinine sulfate ( 0.25 mg per milliliter ) added to each solution to mask the taste . A bronchodilator was given before each dose , and other st and ard therapies were continued during the trial . RESULTS The primary outcome measure , the rate of change ( slope ) in lung function ( reflected by the forced vital capacity [ FVC ] , forced expiratory volume in one second [ FEV1 ] , and forced expiratory flow at 25 to 75 percent of FVC [ FEF25 - 75 ] ) during the 48 weeks of treatment , did not differ significantly between groups ( P=0.79 ) . However , the absolute difference in lung function between groups was significant ( P=0.03 ) when averaged across all post-r and omization visits in the 48-week treatment period . As compared with the control group , the hypertonic-saline group had significantly higher FVC ( by 82 ml ; 95 percent confidence interval , 12 to 153 ) and FEV1 ( by 68 ml ; 95 percent confidence interval , 3 to 132 ) values , but similar FEF25 - 75 values . The hypertonic-saline group also had significantly fewer pulmonary exacerbations ( relative reduction , 56 percent ; P=0.02 ) and a significantly higher percentage of patients without exacerbations ( 76 percent , as compared with 62 percent in the control group ; P=0.03 ) . Hypertonic saline was not associated with worsening bacterial infection or inflammation . CONCLUSIONS Hypertonic saline preceded by a bronchodilator is an inexpensive , safe , and effective additional therapy for patients with cystic fibrosis . ( Clinical Trials.gov number , NCT00271310 . BACKGROUND : Positive expiratory pressure ( PEP ) is used for airway clearance in cystic fibrosis ( CF ) patients . Hypertonic saline ( HTS ) aerosol increases sputum expectoration volume and may improve respiratory secretion properties . CPAP may also be used to maintain airway patency and mobilize secretions . To evaluate if CPAP would increase the beneficial clearance effect of HTS in subjects with CF , we investigated the effects of CPAP alone and CPAP followed by HTS on sputum physical properties and expectoration volume in CF subjects . METHODS : In this crossover study , 15 CF subjects ( mean age 19 y old ) were r and omized to interventions , 48 hours apart : directed coughs ( control ) , CPAP at 10 cm H2O , HTS 7 % , and both CPAP and HTS ( CPAP+HTS ) . Sputum collection was performed at baseline and after interventions . Expectorated volume was determined and in vitro sputum properties were analyzed for contact angle and cough clearability . RESULTS : There were no significant differences between any treatment in arterial blood pressure , heart rate , or pulse oximetry , between the 2 time points . HTS and CPAP+HTS improved cough clearability by 50 % ( P = .001 ) and expectorated volume secretion by 530 % ( P = .001 ) . However , there were no differences between control and CPAP on sputum contact angle , cough clearability , or volume of expectorated secretion . CONCLUSIONS : CPAP alone had no effect on mucus clearance , sputum properties , or expectorated volume , and did not potentiate the effect of HTS alone in CF subjects BACKGROUND Cystic fibrosis ( CF ) airways are nitric oxide ( NO ) deficient . We studied safety and efficacy of repeated inhalations of nebulized L-arginine , the substrate for NO synthase ( NOS ) , in patients with CF . METHODS Double-blind , r and omized , place
Output:
| The effects of the various regimens on lung function were non-significant .
People with cystic fibrosis could be encouraged to inhale hypertonic saline before or during airway clearance techniques to maximise perceived efficacy and satisfaction , even though these timing regimens may not have any better effect on lung function than inhalation after airway clearance techniques . |
MS210973 | ***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 AND OBJECTIVES : Data from a r and omized , controlled study of adenotonsillectomy for obstructive sleep apnea syndrome ( OSAS ) were used to test the hypothesis that children undergoing surgery had greater quality of life ( QoL ) and symptom improvement than control subjects . The objectives were to compare changes in vali date d QoL and symptom measurements among children r and omized to undergo adenotonsillectomy or watchful waiting ; to determine whether race , weight , or baseline OSAS severity influenced changes in QoL and symptoms ; and to evaluate associations between changes in QoL or symptoms and OSAS severity . METHODS : Children aged 5 to 9.9 years with OSAS ( N = 453 ) were r and omly assigned to undergo adenotonsillectomy or watchful waiting with supportive care . Polysomnography , the Pediatric Quality of Life inventory , the Sleep-Related Breathing Scale of the Pediatric Sleep Question naire , the 18-item Obstructive Sleep Apnea QoL instrument , and the modified Epworth Sleepiness Scale were completed at baseline and 7 months . Changes in the QoL and symptom surveys were compared between arms . Effect modification according to race and obesity and associations between changes in polysomnographic measures and QoL or symptoms were examined . RESULTS : Greater improvements in most QoL and symptom severity measurements were observed in children r and omized to undergo adenotonsillectomy , including the parent-completed Pediatric Quality of Life inventory ( effect size [ ES ] : 0.37 ) , the 18-item Obstructive Sleep Apnea QoL instrument ( ES : –0.93 ) , the modified Epworth Sleepiness Scale score ( ES : –0.42 ) , and the Sleep-Related Breathing Scale of the Pediatric Sleep Question naire ( ES : –1.35 ) . Effect modification was not observed by obesity or baseline severity but was noted for race in some symptom measures . Improvements in OSAS severity explained only a small portion of the observed changes . CONCLUSIONS : Adenotonsillectomy compared with watchful waiting result ed in significantly more improvements in parent-rated generic and OSAS-specific QoL measures and OSAS symptoms BACKGROUND The relative importance of obesity and adenotonsillar hypertrophy in the pathogenesis of obstructive sleep-disordered breathing ( SDB ) in childhood is unclear . Adenotonsillectomy ( AT ) for SDB is not always curative , and obese children are at increased risk for residual disease postoperatively . OBJECTIVE The aim of this investigation was to assess the efficacy of AT as treatment for SDB in obese and nonobese children . METHODS Children with adenoidal and /or tonsillar hypertrophy who underwent AT for the treatment of SDB underwent polysomnography preoperatively and postoperatively . A body mass index ( BMI ) z score of > 1.645 was used to define obesity . The achievement of a postoperative obstructive apnea-hypopnea index ( OAHI ) of less than one episode per hour ( ie , the cure of SDB ) was the primary outcome measure . RESULTS Twenty-two obese children ( mean [ + /- SD ] age , 5.8 + /- 1.8 years ; mean BMI z score , 2.6 + /- 0.8 ; mean OAHI , 9.5 + /- 9.7 episodes per hour ) and 48 nonobese children ( mean age , 6.9 + /- 2.6 years ; mean BMI z score , 0.09 + /- 1.1 ; OAHI , 6 + /- 5.4 episodes per hour ) were recruited . After surgery , obese and nonobese subjects did not differ in the efficacy of AT ( postoperative OAHI of less than one episode per hour , 22.7 % vs 25 % of subjects , respectively ; p > 0.05 ) . The presence of obesity , adenoidal or tonsillar hypertrophy , gender , and postoperative BMI change were not significant predictors of SDB cure . CONCLUSIONS Obesity does not necessarily predict an unfavorable outcome of AT as treatment for SDB OBJECTIVE To evaluate the efficacy of adenotonsillectomy ( AT ) in the treatment of children with obstructive sleep apnea ( OSA ) in a 3-y prospect i ve , longitudinal study with analysis of risk factors of recurrence of OSA . STUDY DESIGN An investigation of children ( 6 to 12 y old ) with OSA documented at entry and followed posttreatment at 6 , 12 , 24 , and 36 mo with examination , question naires , and polysomnography . Multivariate generalized linear modeling and hierarchical linear models analysis were used to determine contributors to suboptimal long-term resolution of OSA , and Generalized Linear Models were used for analysis of risk factors of recurrence . RESULTS Of the 135 children , 88 terminated the study at 36 months post-AT . These 88 children ( boys = 72 , mean age = 8.9 ± 2.7 yersus boys 8.9 ± 2.04 y , girls : 8.8 ± 2.07 y ; body mass index [ BMI ] = 19.5 ± 4.6 kg/m(2 ) ) had a preoperative mean apnea-hypopnea index ( AHI0 ) of 13.54 ± 7.23 and a mean postoperative AHI at 6 mo ( AHI6 ) of 3.47 ± 8.41 events/h ( with AHI6 > 1 = 53.4 % of 88 children ) . A progressive increase in AHI was noted with a mean AHI36 = 6.48 ± 5.57 events/h and AHI36 > 1 = 68 % of the studied group . Change in AHI was associated with changes in the OSA-18 question naire . The residual pediatric OSA after AT was significantly associated with BMI , AHI , enuresis , and allergic rhinitis before surgery . From 6 to 36 mo after AT , recurrence of pediatric OSA was significantly associated with enuresis , age ( for the 24- to 36-mo period ) , postsurgery AHI6 ( severity ) , and the rate of change in BMI and body weight . CONCLUSIONS Adenotonsillectomy leads to significant improvement in apnea-hypopnea index , though generally with incomplete resolution , but a worsening over time was observed in 68 % of our cases BACKGROUND AND OBJECTIVES : Adenotonsillectomy for obstructive sleep apnea syndrome ( OSAS ) may lead to weight gain , which can have deleterious health effects when leading to obesity . However , previous data have been from nonr and omized uncontrolled studies , limiting inferences . This study examined the anthropometric changes over a 7-month interval in a r and omized controlled trial of adenotonsillectomy for OSAS , the Childhood Adenotonsillectomy Trial . METHODS : A total of 464 children who had OSAS ( average apnea/hypopnea index [ AHI ] 5.1/hour ) , aged 5 to 9.9 years , were r and omized to Early Adenotonsillectomy ( eAT ) or Watchful Waiting and Supportive Care ( WWSC ) . Polysomnography and anthropometry were performed at baseline and 7-month follow-up . Multivariable regression modeling was used to predict the change in weight and growth indices . RESULTS : Interval increases in the BMI z score ( 0.13 vs 0.31 ) was observed in both the WWSC and eAT intervention arms , respectively , but were greater with eAT ( P < .0001 ) . Statistical modeling showed that BMI z score increased significantly more in association with eAT after considering the influences of baseline weight and AHI . A greater proportion of overweight children r and omized to eAT compared with WWSC developed obesity over the 7-month interval ( 52 % vs 21 % ; P < .05 ) . Race , gender , and follow-up AHI were not significantly associated with BMI z score change . CONCLUSIONS : eAT for OSAS in children results in clinical ly significant greater than expected weight gain , even in children overweight at baseline . The increase in adiposity in overweight children places them at further risk for OSAS and the adverse consequences of obesity . Monitoring weight , nutritional counseling , and encouragement of physical activity should be considered after eAT for OSAS BACKGROUND Adenotonsillectomy is commonly performed in children with the obstructive sleep apnea syndrome , yet its usefulness in reducing symptoms and improving cognition , behavior , quality of life , and polysomnographic findings has not been rigorously evaluated . We hypothesized that , in children with the obstructive sleep apnea syndrome without prolonged oxyhemoglobin desaturation , early adenotonsillectomy , as compared with watchful waiting with supportive care , would result in improved outcomes . METHODS We r and omly assigned 464 children , 5 to 9 years of age , with the obstructive sleep apnea syndrome to early adenotonsillectomy or a strategy of watchful waiting . Polysomnographic , cognitive , behavioral , and health outcomes were assessed at baseline and at 7 months . RESULTS The average baseline value for the primary outcome , the attention and executive-function score on the Developmental Neuropsychological Assessment ( with scores ranging from 50 to 150 and higher scores indicating better functioning ) , was close to the population mean of 100 , and the change from baseline to follow-up did not differ significantly according to study group ( mean [ ±SD ] improvement , 7.1±13.9 in the early-adenotonsillectomy group and 5.1±13.4 in the watchful-waiting group ; P=0.16 ) . In contrast , there were significantly greater improvements in behavioral , quality -of-life , and polysomnographic findings and significantly greater reduction in symptoms in the early-adenotonsillectomy group than in the watchful-waiting group . Normalization of polysomnographic findings was observed in a larger proportion of children in the early-adenotonsillectomy group than in the watchful-waiting group ( 79 % vs. 46 % ) . CONCLUSIONS As compared with a strategy of watchful waiting , surgical treatment for the obstructive sleep apnea syndrome in school-age children did not significantly improve attention or executive function as measured by neuropsychological testing but did reduce symptoms and improve secondary outcomes of behavior , quality of life , and polysomnographic findings , thus providing evidence of beneficial effects of early adenotonsillectomy . ( Funded by the National Institutes of Health ; CHAT Clinical Trials.gov number , NCT00560859 . ) OBJECTIVES : Children with nonsevere obstructive sleep apnea ( OSA ) benefit from alternative therapeutic interventions such as leukotriene modifiers . We hypothesized that montelukast might improve OSA in children . We tested this hypothesis in a double-blind , r and omized , placebo-controlled fashion . METHODS : Of 50 possible c and i date s , we recruited 46 children with polysomnographically diagnosed OSA . In this prospect i ve , double-blind , r and omized trial , children received daily oral montelukast at 4 or 5 mg ( < 6 or > 6 years of age , respectively ) or placebo for 12 weeks . Polysomnographic assessment s , parent question naires , and radiographs to assess adenoid size were performed before and after therapy . RESULTS : Compared with the 23 children that received placebo , the 23 children that received montelukast showed significant improvements in polysomnographic measures of respiratory disturbance ( obstructive apnea index ) , children 's symptoms , and adenoid size . The obstructive apnea index decreased by > 50 % in 65.2 % of treated children . No attrition or side effects occurred . CONCLUSIONS : A 12-week treatment with daily , oral montelukast effectively reduced the severity of OSA and the magnitude of the underlying adenoidal hypertrophy in children with nonsevere OSA Objectives : To evaluate the impact of adenotonsillectomy ( T&A ) on quality -of-life ( QOL ) and behavior in obese versus normal-weight children with Obstructive Sleep Apnea ( OSA ) . Design : Prospect i ve , non-r and omized , controlled study . Methods : Children with an apnea-hypopnea index ( AHI ) ≥2 were studied . Polysomnography was performed before and after T&A. An age- and gender-specific body mass index ( BMI -for-age ) percentile was determined preoperatively . Children who were obese ( > 95th percentile ) were compared to normal-weight children ( BMI -for-age > 5th–85th percentile ) . Caregivers completed the OSA-18 QOL survey and the Behavioral Assessment Survey for Children ( BASC ) before surgery and 3–6 months postoperatively . Pre- and postoperative scores were compared using paired t-tests , and the impact of covariants was analyzed using ANOVA . Results : The study population consisted of 89 children , 40 of whom were obese ( 45 % ) . Postoperative scores for AHI , OSA-18 total and domain scores , and BASC scales and composites were significantly lower ( improved ) compared to pre-operative values in all children ( p < .001 ) . All mean OSA-18 and BASC scores were higher ( indicating worse quality -of-life and behavior ) pre- and postoperatively in obese than in normal-weight children . Postoperatively , the majority of OSA-18 total scores and domain scores were significantly higher in obese children . A comparison of the total OSA-18 scores between children with a postoperative AHI < 2 and A
Output:
| In the CHAT trial , at seven months , neurocognitive performance and attention and executive function had not improved with surgery : scores were similar in both groups .
In otherwise healthy children , without a syndrome , of older age ( five to nine years ) , and diagnosed with mild to moderate OSAS by PSG , there is moderate quality evidence that adenotonsillectomy provides benefit in terms of quality of life , symptoms and behaviour as rated by caregivers and high quality evidence that this procedure is beneficial in terms of PSG parameters .
At the same time , high quality evidence indicates no benefit in terms of objective measures of attention and neurocognitive performance compared with watchful waiting .
Furthermore , PSG recordings of almost half of the children managed non-surgically had normalised by seven months , indicating that physicians and parents should carefully weigh the benefits and risks of adenotonsillectomy against watchful waiting in these children . |
MS210974 | ***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 classic , unresolved physiological question is whether central cardiorespiratory and /or local skeletal muscle circulatory factors limit maximal aerobic capacity ( & OV0312;o2max ) in humans . Severe heat stress drastically reduces & OV0312;o2max , but the mechanisms have never been studied . Methods and Results —To determine the main contributing factor that limits & OV0312;o2max with and without heat stress , we measured hemodynamics in 8 healthy males performing intense upright cycling exercise until exhaustion starting with either high or normal skin and core temperatures ( + 10 ° C and + 1 ° C ) . Heat stress reduced & OV0312;o2max , 2-legged & OV0312;o2 , and time to fatigue by 0.4±0.1 L/min ( 8 % ) , 0.5±0.2 L/min ( 11 % ) , and 2.2±0.4 minutes ( 28 % ) , respectively ( all P < 0.05 ) , despite heart rate and core temperature reaching similar peak values . However , before exhaustion in both heat stress and normal conditions , cardiac output , leg blood flow , mean arterial pressure , and systemic and leg O2 delivery declined significantly ( all 5 % to 11 % , P < 0.05 ) , yet arterial O2 content and leg vascular conductance remained unchanged . Despite increasing leg O2 extraction , leg & OV0312;o2 declined 5 % to 6 % before exhaustion in both heat stress and normal conditions , accompanied by enhanced muscle lactate accumulation and ATP and creatine phosphate hydrolysis . Conclusions —These results demonstrate that in trained humans , severe heat stress reduces & OV0312;o2max by accelerating the declines in cardiac output and mean arterial pressure that lead to decrements in exercising muscle blood flow , O2 delivery , and O2 uptake . Furthermore , the impaired systemic and skeletal muscle aerobic capacity that precedes fatigue with or without heat stress is largely related to the failure of the heart to maintain cardiac output and O2 delivery to locomotive muscle PURPOSE To determine the effect of a 48-h period of either fluid restriction ( FR ) , energy restriction ( ER ) , or fluid and energy restriction ( F + ER ) on 30-min treadmill time trial ( TT ) performance in temperate conditions . METHODS Thirteen males participated in four r and omized 48-h trials ( mean + /- SD : age , 21 + /- 3 yr ; VO2max 50.9 + /- 4.3 mL x kg(-1 ) x min(-1 ) ) . Control ( CON ) participants received their estimated energy ( 2903 + /- 199 kcal x d(-1 ) ) and water ( 3912 + /- 500 mL x d(-1 ) ) requirements . For FR , participants received their energy requirements and 193 + /- 50 mL x d(-1 ) water to drink , and for ER , participants received their water requirements and 290 + /- 20 kcal x d(-1 ) . F + ER was a combination of FR and ER . After 48 h , participants performed a 30-min treadmill TT in temperate conditions ( 19.7 + /- 0.6 degrees C ) . A separate investigation ( N = 10 ) showed the TT to be highly reproducible ( CV 1.6 % ) . RESULTS Body mass loss ( BML ) was 0.6 + /- 0.4 % ( CON ) , 3.2 + /- 0.5 % ( FR ) , 3.4 + /- 0.3 % ( ER ) , and 3.6 + /- 0.3 % ( F + ER ) . Compared with CON ( 6295 + /- 513 m ) , less distance was completed on ER ( 10.3 % ) and F + ER ( 15.0 % : P < 0.01 ) . Although less distance was completed on FR ( 2.8 % ) , this was not significantly different from CON . CONCLUSIONS These results show a detrimental effect of a 48-h period of ER but no significant effect of FR on 30-min treadmill TT performance in temperate conditions . Therefore , these results do not support the popular contention that modest hypohydration ( 2 - 3 % BML ) significantly impairs endurance performance in temperate conditions This investigation determined the effect of different rates of dehydration , induced by ingesting different volumes of fluid during prolonged exercise , on hyperthermia , heart rate ( HR ) , and stroke volume ( SV ) . On four different occasions , eight endurance-trained cyclists [ age 23 + /- 3 ( SD ) yr , body wt 71.9 + /- 11.6 kg , maximal O2 consumption 4.72 + /- 0.33 l/min ] cycled at a power output equal to 62 - 67 % maximal O2 consumption for 2 h in a warm environment ( 33 degrees C dry bulb , 50 % relative humidity , wind speed 2.5 m/s ) . During exercise , they r and omly received no fluid ( NF ) or ingested a small ( SF ) , moderate ( MF ) , or large ( LF ) volume of fluid that replaced 20 + /- 1 , 48 + /- 1 , and 81 + /- 2 % , respectively , of the fluid lost in sweat during exercise . The protocol result ed in grade d magnitudes of dehydration as body weight declined 4.2 + /- 0.1 , 3.4 + /- 0.1 , 2.3 + /- 0.1 , and 1.1 + /- 0.1 % , respectively , during NF , SF , MF , and LF . After 2 h of exercise , esophageal temperature ( Tes ) , HR , and SV were significantly different among the four trials ( P < 0.05 ) , with the exception of NF and SF . The magnitude of dehydration accrued after 2 h of exercise in the four trials was linearly related with the increase in Tes ( r = 0.98 , P < 0.02 ) , the increase in HR ( r = 0.99 , P < 0.01 ) , and the decline in SV ( r = 0.99 , P < 0.01 ) . LF attenuated hyperthermia , apparently because of higher skin blood flow , inasmuch as forearm blood flow was 20 - 22 % higher than during SF and NF at 105 min ( P < 0.05 ) . There were no differences in sweat rate among the four trials . In each subject , the increase in Tes from 20 to 120 min of exercise was highly correlated to the increase in serum osmolality ( r = 0.81 - 0.98 , P < 0.02 - 0.19 ) and the increase in serum sodium concentration ( r = 0.87 - 0.99 , P < 0.01 - 0.13 ) from 5 to 120 min of exercise . In summary , the magnitude of increase in core temperature and HR and the decline in SV are grade d in proportion to the amount of dehydration accrued during exercise 1 . The present study examined whether the blood flow to exercising muscles becomes reduced when cardiac output and systemic vascular conductance decline with dehydration during prolonged exercise in the heat . A secondary aim was to determine whether the upward drift in oxygen consumption ( VO2 ) during prolonged exercise is confined to the active muscles . 2 . Seven euhydrated , endurance-trained cyclists performed two bicycle exercise trials in the heat ( 35 C ; 40 - 50 % relative humidity ; 61 + /- 2 % of maximal VO2 ) , separated by 1 week . During the first trial ( dehydration trial , DE ) , they bicycled until volitional exhaustion ( 135 + /- 4 min , mean + /- s.e.m . ) , while developing progressive dehydration and hyperthermia ( 3.9 + /- 0.3 % body weight loss ; 39.7 + /- 0.2 C oesophageal temperature , Toes ) . In the second trial ( control trial ) , they bicycled for the same period of time while maintaining euhydration by ingesting fluids and stabilizing Toes at 38.2 + /- 0.1 C after 30 min exercise . 3 . In both trials , cardiac output , leg blood flow ( LBF ) , vascular conductance and VO2 were similar after 20 min exercise . During the 20 min-exhaustion period of DE , cardiac output , LBF and systemic vascular conductance declined significantly ( 8 - 14 % ; P < 0.05 ) yet muscle vascular conductance was unaltered . In contrast , during the same period of control , all these cardiovascular variables tended to increase . After 135 + /- 4 min of DE , the 2.0 + /- 0.6 l min-1 lower blood flow to the exercising legs accounted for approximately two-thirds of the reduction in cardiac output . Blood flow to the skin also declined markedly as forearm blood flow was 39 + /- 8 % ( P < 0.05 ) lower in DE vs. control after 135 + /- 4 min . 4 . In both trials , whole body VO2 and leg VO2 increased in parallel and were similar throughout exercise . The reduced leg blood flow in DE was accompanied by an even greater increase in femoral arterial-venous O2 ( a-vO2 ) difference . 5 . It is concluded that blood flow to the exercising muscles declines significantly with dehydration , due to a lowering in perfusion pressure and systemic blood flow rather than increased vasoconstriction . Furthermore , the progressive increase in oxygen consumption during exercise is confined to the exercising skeletal muscles AIM The purpose of this study was to investigate the effect of hypohydration ( HH ) on the lactate threshold ( LT ) in a hot and humid environment . METHODS Ten apparently healthy males ( age 25+/-3 yrs ; height 1.8+/-0.04 m ; mass 78+/-12 kg ; VO2peak 3.7+/-0.4 L/min ) underwent four r and omly assigned maximal treadmill tests . Two trials were at room temperature ( 22+/-1 degrees C ; RH = 50 % ) under two different hydration conditions : euhydrated ( EH-RM ) and hypohydrated ( HH-RM ) , and two trials were performed in a warm chamber ( 37+/-0.5 degrees C ; RH = 70 % ) under two different hydration conditions : euhydrated ( EH-HT ) and hypohydrated ( HH-HT ) . The desired HH level ( 2 - 4 % ) was accomplished in the 24 + hours before testing by fluid restriction . Mean HH was 2.6+/-1.0 % body weight . Capillary blood sample s were collected at the end of each stage and analyzed for lactic acid ( LA ) . LA concentrations were plotted for each exercise stage , and the LT was determined by visual inspection as the highest exercise stage at which blood LA concentration began to increase above each individual 's resting levels . LT and body temperature were analyzed with a two-way repeated measures ANOVA ( P < 0.05 ) . RESULTS During the trials in the warm chamber , the LT occurred at a significantly earlier stage compared to the thermoneutral environment ( 4.4+/-0.09 vs 5.8+/-0.10 ) and with a significantly lower oxygen consumption ( 2.38+/-0.09 L.min(-1 ) vs 2.86+/-0.13 L.min(-1 ) ) . Body temperature at the LT was significantly higher in the heat trials compared to room temperature ( 38.7+/-0.12 degrees C vs 37.6+/-0.14 degrees C ) . LT determination was not significantly altered by hydration . CONCLUSION These results suggest that during progressive incremental maximal treadmill exercise , moderate HH does not affect the LT , whereas exercise in a hot and humid environment induces a downward shift in the LT . The elevated body temperature during the heat trials suggests that body temperature may affect running performance associated with the LT CONTEXT Authors of most field studies have not observed decrements in physiologic function and performance with increases in dehydration , although authors of well-controlled laboratory studies have consistently reported this relationship . Investigators in these field studies did not control exercise intensity , a known modulator of body core temperature . OBJECTIVE To directly examine the effect of moderate water deficit on the physiologic responses to various exercise intensities in a warm outdoor setting . DESIGN Semir and omized , crossover design . SETTING Field setting . PATIENTS OR OTHER PARTICIPANTS Seventeen distance runners ( 9 men , 8 women ; age = 27 + /- 7 years , height = 171 + /- 9 cm , mass = 64.2 + /- 9.0 kg , body fat = 14.6 % + /- 5.5 % ) . INTERVENTION(S ) Participants completed four 12-km runs ( consisting of three 4-km loops ) in the heat ( average wet bulb globe temperature = 26.5 degrees C ) : ( 1 ) a hydrated , race trial ( HYR ) , ( 2 ) a dehydrated , race trial ( DYR ) , ( 3 ) a hydrated , submaximal trial ( HYS ) , and ( 4 ) a dehydrated , submaximal trial ( DYS ) . MAIN OUTCOME MEASURE(S ) For DYR and DYS trials , dehydration was measured by body mass loss . In the submaximal trials , participants ran at
Output:
| However , no systematic approach has yet been used to determine how pre-exercise hypohydration , which imposes physiological challenges differing from those of a well-hydrated pre-exercise state , affects AEP and related components such as peak oxygen consumption (V˙O2peak)\documentclass[12pt]{minimal } \usepackage{amsmath } \usepackage{wasysym } \usepackage{amsfonts } \usepackage{amssymb } \usepackage{amsbsy } \usepackage{mathrsfs } \usepackage{upgreek } \setlength{\oddsidemargin}{-69pt } \begin{document}$$(\dot{V}{\text{O}}_{{2{\text{peak } } } } ) $ $ \end{document } and V˙O2\documentclass[12pt]{minimal } \usepackage{amsmath } \usepackage{wasysym } \usepackage{amsfonts } \usepackage{amssymb } \usepackage{amsbsy } \usepackage{mathrsfs } \usepackage{upgreek } \setlength{\oddsidemargin}{-69pt } \begin{document}$$\dot{V}{\text{O}}_{2}$$\end{document } at lactate threshold (V˙O2LT)\documentclass[12pt]{minimal } \usepackage{amsmath } \usepackage{wasysym } \usepackage{amsfonts } \usepackage{amssymb } \usepackage{amsbsy } \usepackage{mathrsfs } \usepackage{upgreek } \setlength{\oddsidemargin}{-69pt } \begin{document}$$(\dot{V}{\text{O}}_{2 } { \text{LT}})$$\end{document}. To determine , using a systematic approach with meta- analysis , the magnitude of the effect of pre-exercise hypohydration on AEP , V˙O2peak\documentclass[12pt]{minimal } \usepackage{amsmath } \usepackage{wasysym } \usepackage{amsfonts } \usepackage{amssymb } \usepackage{amsbsy } \usepackage{mathrsfs } \usepackage{upgreek } \setlength{\oddsidemargin}{-69pt } \begin{document}$$\dot{V}{\text{O}}_{{2{\text{peak}}}}$$\end{document } and V˙O2LT\documentclass[12pt]{minimal } \usepackage{amsmath } \usepackage{wasysym } \usepackage{amsfonts } \usepackage{amssymb } \usepackage{amsbsy } \usepackage{mathrsfs } \usepackage{upgreek } \setlength{\oddsidemargin}{-69pt } \begin{document}$$\dot{V}{\text{O}}_{2 } { \text{LT}}$$\end{document}. This was a systematic review with meta- analysis of well-controlled studies .
Compared with starting an exercise hypohydrated , it is respectively likely , possible and likely that AEP , V˙O2peak\documentclass[12pt]{minimal } \usepackage{amsmath } \usepackage{wasysym } \usepackage{amsfonts } \usepackage{amssymb } \usepackage{amsbsy } \usepackage{mathrsfs } \usepackage{upgreek } \setlength{\oddsidemargin}{-69pt } \begin{document}$$\dot{V}{\text{O}}_{{2{\text{peak}}}}$$\end{document } and V˙O2LT\documentclass[12pt]{minimal } \usepackage{amsmath } \usepackage{wasysym } \usepackage{amsfonts } \usepackage{amssymb } \usepackage{amsbsy } \usepackage{mathrsfs } \usepackage{upgreek } \setlength{\oddsidemargin}{-69pt } \begin{document}$$\dot{V}{\text{O}}_{2 } { \text{LT}}$$\end{document } benefit from a euhydrated state prior to exercise .
Pre-exercise hypohydration likely impairs AEP and likely reduces V˙O2LT\documentclass[12pt]{minimal } \usepackage{amsmath } \usepackage{wasysym } \usepackage{amsfonts } \usepackage{amssymb } \usepackage{amsbsy } \usepackage{mathrsfs } \usepackage{upgreek } \setlength{\oddsidemargin}{-69pt } \begin{document}$$\dot{V}{\text{O}}_{2 } { \text{LT}}$$\end{document } ( i.e. , the aerobic contribution to exercise was lower ) during running and cycling exercises ≤ 1 h across different environmental conditions ( i.e. , from 19 to 40 ° C ) .
Moreover , pre-exercise hypohydration possibly impedes V˙O2peak\documentclass[12pt]{minimal } \usepackage{amsmath } \usepackage{wasysym } \usepackage{amsfonts } \usepackage{amssymb } \usepackage{amsbsy } \usepackage{mathrsfs } \usepackage{upgreek } \setlength{\oddsidemargin}{-69pt } \begin{document}$$\dot{V}{\text{O}}_{{2{\text{peak}}}}$$\end{document } during such exercises |
MS210975 | ***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 We evaluate the 6-month efficacy of Keep Active Minnesota , a phone- and mail-based physical activity maintenance intervention design ed for use with adults age 50 to 70 years who have increased their physical activity within the past year . METHOD Participants ( N=1049 ) recruited in 2004 and 2005 from one large managed-care organization in Minnesota were r and omly assigned to either treatment ( N=523 ) or usual care ( N=526 ) with physical activity assessed using the Community Healthy Activities Model Program for Seniors question naire , and expressed as kcal/week expenditures . RESULTS Total physical activity at baseline was similar for treatment and usual care participants ( p<0.44 ) as was moderate/vigorous physical activity ( p<0.21 ) . Maintenance of physical activity was higher among treatment participants whose mean 6-month change in total kcal/week energy expenditure was -91 , compared to -683 for usual care participants ( p<0.002 ) . Mean 6-month change in kcal/week expenditure in moderate or vigorous activities was -49 for treatment participants , compared to -612 for usual care participants ( p<0.001 ) . CONCLUSIONS This phone- and mail-based physical activity maintenance intervention is efficacious at maintaining physical activity at 6 months Although telephone and mail are often used to promote physical activity adoption , their ability to produce long-term maintenance is unclear . In this study , 140 men and women aged 50 - 65 years received 1 year of telephone counseling to adopt higher ( i.e. , more vigorous ) versus lower intensity ( i.e. , moderate ) exercise . After 1 year , participants were rer and omized to a 2nd year of contact via ( a ) telephone and mail or ( b ) predominantly mail . Participants who were prescribed higher intensity exercise and received predominantly mail had better exercise adherence during the maintenance year than those who received telephone and mail . Both strategies were similarly effective in promoting maintenance in the lower intensity condition . Results suggest that after successful adoption of physical activity with the help of telephone counseling , less intensive interventions are successful for physical activity maintenance in older adults OBJECTIVE To evaluate the efficacy at 6- , 12- , and 24-month follow-up of Keep Active Minnesota ( KAM ) , a telephone and mail-based intervention design ed to promote physical activity ( PA ) maintenance among currently active adults age 50 to 70 . METHOD Participants who reported having recently increased their MVPA to a minimum of 2d/wk , 30 min/bout , ( N=1049 ) were recruited in 2004 and 2005 from one large managed care organization in Minnesota , and r and omly assigned to either treatment ( KAM ; N=523 ) , or Usual Care ( UC ; N=526 ) with PA assessed using the CHAMPS question naire , and expressed as kcal/wk energy expenditure . RESULTS We find a sustained , significant benefit of the intervention at 6 , 12 and 24 months . kcal/wk expenditure in moderate or vigorous activities was higher at 6 ( p<.03 , Cohen 's d(6m)=.16 ) , 12 ( p<.04 , d(12 m)=.13 ) and 24 months ( p<.01 , d(24 m)=.16 ) for KAM participants , compared to UC participants . CONCLUSIONS The KAM telephone- and mail-based PA maintenance intervention was effective at maintaining PA in both the short-term ( 6 months ) and longer-term ( 12 and 24 months ) relative to usual care Background Important health benefits can be derived when low-cost ( e.g. , computer-tailored ) physical activity interventions for older adults demonstrate sustained effects . Purpose The purpose of the study was to conduct in-depth analysis on the long-term efficacy of two tailored physical activity interventions for older adults . Methods A r and omized controlled trial ( n = 1,971 ) with two computer-tailored interventions and a no-intervention control group was conducted . The two tailored interventions consisted of three tailored letters , delivered during 4 months . The basic tailored intervention targeted psychosocial determinants alone , while the environmentally tailored intervention additionally targeted environmental determinants , by providing tailored environmental information . Self-reported behaviors ( i.e. , total physical activity , transport walking and cycling , leisure walking and cycling , and sports ) were measured at baseline and 12 months . Additionally , potential personal , health-related , and psychosocial moderators of the intervention effects were examined . Results The environmentally tailored intervention was effective in changing total physical activity , leisure cycling , and sports compared with the basic intervention and control group . No intervention effects were found for the basic intervention . Moderation analysis revealed that participants with a higher age , lower body mass index , and higher intention were unresponsive to the interventions . Conclusions Providing environmental information is an effective intervention strategy for increasing physical activity behaviors among older adults , especially among certain “ at-risk ” subgroups such as lower educated , overweight , or insufficiently active participants . Moderation analysis was perceived as a promising method for identifying meaningful subgroups that are unaffected by an intervention , which should receive special attention in future interventions Background : Attempts to study the translation of evidence -based physical activity interventions in community setting s are scarce . Purpose : This project was an investigation of whether 13 diverse local lead agencies could effectively implement a choice-based , telephone-assisted physical activity promotion program for older adults based on intervention models proven efficacious in research setting s. Methods : At baseline , participants developed their own physical activity programs through an individualized planning session based on preference , health status , readiness to change , and available community re sources . Thereafter , participants received regular telephone calls over a 1-year period from a trained staff member or volunteer support buddy . Additional program components consisted of health education workshops , newsletters , and group-based physical activities . Self-report data on caloric expenditure due to all and moderate or greater intensity physical activities were collected from 447 participants ( M age = 68 ± 8.6 years ) . Results : A significant increase ( p ≤ .0001 ) from baseline to midintervention and intervention endpoint was observed for total weekly caloric expenditure ( Mdn change = 644–707 kcal/week ) and moderate or greater weekly caloric expenditure ( Mdn change = 149–265 kcal/week ) , as well as for weekly physical activity duration and frequency . These changes were observed in participants across all sites . Conclusions : The increases in weekly caloric expenditure were commensurate with findings from several previous r and omized clinical trials . The utilization of community agency staff and volunteers receiving basic training to implement essential program components proved feasible . Very favorable levels of program satisfaction expressed by community staff , volunteer support buddies , and participants , combined with the significant increases in physical activity , warrant further dissemination of the intervention model Background Physical activity ( PA ) for older adults has well-documented physical and cognitive benefits , but most seniors do not meet recommended guidelines for PA , and interventions are lacking . Objectives This study evaluated the efficacy of a 12-week Internet intervention to help sedentary older adults over 55 years of age adopt and maintain an exercise regimen . Methods A total of 368 sedentary men and women ( M=60.3 ; SD 4.9 ) were recruited , screened , and assessed online . They were r and omized into treatment and control groups and assessed at pretest , at 12 weeks , and at 6 months . After treatment group participants rated their fitness level , activity goals , and barriers to exercise , the Internet intervention program helped them select exercise activities in the areas of endurance , flexibility , strengthening , and balance enhancement . They returned to the program weekly for automated video and text support and education , with the option to change or increase their exercise plan . The program also included ongoing problem solving to overcome user-identified barriers to exercise . Results The multivariate model indicated significant treatment effects at posttest ( P=.001 ; large effect size ) and at 6 months ( P=.001 ; medium effect size ) . At posttest , intervention participation showed significant improvement on 13 of 14 outcome measures compared to the control participants . At 6 months , treatment participants maintained large gains compared to the control participants on all 14 outcome measures . Conclusions These results suggest that an online PA program has the potential to positively impact the physical activity of sedentary older adult participants . More research is needed to replicate the study results , which were based on self-report measures . Research is also needed on intervention effects with older population BACKGROUND The present study examined whether aerobic fitness training of older humans can increase brain volume in regions associated with age-related decline in both brain structure and cognition . METHODS Fifty-nine healthy but sedentary community-dwelling volunteers , aged 60 - 79 years , participated in the 6-month r and omized clinical trial . Half of the older adults served in the aerobic training group , the other half of the older adults participated in the toning and stretching control group . Twenty young adults served as controls for the magnetic resonance imaging ( MRI ) , and did not participate in the exercise intervention . High spatial resolution estimates of gray and white matter volume , derived from 3D spoiled gradient recalled acquisition MRI images , were collected before and after the 6-month fitness intervention . Estimates of maximal oxygen uptake ( VO2 ) were also obtained . RESULTS Significant increases in brain volume , in both gray and white matter regions , were found as a function of fitness training for the older adults who participated in the aerobic fitness training but not for the older adults who participated in the stretching and toning ( nonaerobic ) control group . As predicted , no significant changes in either gray or white matter volume were detected for our younger participants . CONCLUSIONS These results suggest that cardiovascular fitness is associated with the sparing of brain tissue in aging humans . Furthermore , these results suggest a strong biological basis for the role of aerobic fitness in maintaining and enhancing central nervous system health and cognitive functioning in older adults PURPOSE Given the prevalence of physical inactivity among American adults , convenient , low-cost interventions are strongly indicated . This study determined the 6- and 12-month effectiveness of telephone interventions delivered by health educators or by an automated computer system in promoting physical activity . DESIGN Initially inactive men and women age 55 years and older ( N = 218 ) in stable health participated . Participants were r and omly assigned to human advice , automated advice , or health education control . MEASURES The vali date d 7-day physical activity recall interview was used to estimate minutes of moderate to vigorous physical activity . Physical activity differences by experimental arm were verified on a r and om sub sample via accelerometry . RESULTS Using intention-to-treat analysis , at 6 months , participants in both interventions , although not differing from one another , showed significant improvements in weekly physical activity compared with controls . These differences were generally maintained at 12 months , with both intervention arms remaining above the target of 150 min per week of moderate to vigorous physical activity on average . CONCLUSION Automated telephone-linked delivery systems represent an effective alternative for delivering physical activity advice to inactive older adults OBJECTIVE This study compared a motivational intervention based on protection motivation theory ( PMT , Rogers , 1975 , 1983 ) with the same motivational intervention augmented by a volitional intervention based on implementation intentions ( Gollwitzer , 1993 ) . DESIGN The study had a longitudinal design , involving three waves of data collection over a 2-week period , incorporating an experimental manipulation of PMT variables at Time 1 and a volitional , implementation intention intervention at Time 2 . METHOD Participants ( N=248 ) were r and omly allocated to a control group or one of two intervention groups . Cognitions and exercise behaviour were measured at three time-points over a 2-week period . RESULTS The motivational intervention significantly increased threat and coping appraisal and intentions to engage in exercise but did not bring about a significant increase in subsequent exercise behaviour . In contrast , the combined protection motivation theory/implementation intention intervention had a dramatic effect on subsequent exercise behaviour . This volitional intervention did not influence behavioural intention or any other motivational variables . CONCLUSIONS It is concluded that supplementing PMT with implementation intentions strengthens the ability of the model to explain behaviour . This has implication s for health education programmes , which should aim to increase both participants ' motivation and their volition 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 Objective . To evaluate the effectiveness of a 12-week home-based postal and telephone physical activity and nutrition pilot program for seniors . Methods . The program was delivered by mailed material and telephone calls . The main intervention consisted of a booklet tailored for seniors containing information on dietary guidelines , recommended physical activity
Output:
| From this review , non-face-to-face physical activity interventions effectively promote physical activity in older adults . |
MS210976 | ***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: Summary . Refractoriness to r and om‐donor platelets as a result of alloimmunization remains a major problem in long‐term platelet transfusion therapy despite the use of HLA‐matched platelets . We have therefore studied the use of two methods for detection of platelet associated IgG as platelet crossmatch tests for the selection of platelet donors . These methods use radiolabelled staphylococcal protein A ( 125I‐SPA ) and peroxidase anti‐peroxidase ( PAP ) , respectively Seventy-nine platelet transfusions to 73 thrombocytopenic patients with cancer were analyzed to determine whether a platelet count obtained one hour after transfusion could help differentiate between alloimmunization and other clinical factors that result in rapid platelet destruction . These transfusions were selected because 18- to 24-hour increments were inadequate in response to fresh , r and om donor platelets . A corrected count increment ( Cl ) ( Cl=[posttransfusion count-pretransfusion count]Xbody surface area [ sq m]/platelets transfusedX10 ' ' ) at one hour of 10X103/microliter or greater was associated with absence of lymphocytotoxic antibody , whereas increments of less than 10X103/microliter were generally associated with high levels of strongly cytotoxic antibody . HLA-matched transfusions produced no improvement in increments when the previous one-hour Cl had been 10X103/microliter or greater , whereas in the other group significantly better increments were obtained . A one-hour posttransfusion count is a simple test that correlates well with the presence of antibody against HLA antigens , is valuable in predicting the need for HLA-matched platelets , and helps avoid wasteful , empirical use of such transfusions A latex agglutination assay was evaluated for the purpose of identifying compatible platelet donors for alloimmunized recipients . Assay reagents were prepared by adsorbing detergent-solubilized , donor-specific platelets to polystyrene latex beads . Semiquantitative results for up to 30 donors can be completed in less than 1 hour . These reagents retained their immunoreactivity for at least 3.5 months . A retrospective study has established the assay 's upper limit of compatibility . The prospect i ve study evaluated transfusions to a group of multiply transfused patients . Part I evaluated 143 crossmatched , single-donor platelet transfusions given to 50 patients . In 96 percent of the cases , a positive crossmatch was associated with an unsuccessful transfusion outcome ; in 84 percent of the transfusions , a negative crossmatch predicted a satisfactory platelet increment . The overall predictability , sensitivity , and specificity were 87 , 62 , and 99 percent , respectively . Part II evaluated 105 transfusions given to the 43 patients ( of 50 ) in whom no incidence of fever , sepsis , or bleeding could be documented . A positive crossmatch was 96-percent efficient in predicting an unsuccessful transfusion , whereas a negative crossmatch was associated with an adequate platelet increment following 89 percent of the transfusions . The overall predictability was 91 percent , the sensitivity was 72 percent , and the specificity was 99 percent . Within-run and between-run variations were 6.3 and 6.2 percent , respectively . These results demonstrate that detergent-solubilized platelet antigens , immobilized on latex particles , can be used in a cost-effective crossmatching procedure Although the value of HLA matching for the selection of platelet donors for patients refractory to r and om platelets is beyond doubt , even perfectly matched combinations sometimes fail to give a satisfactory transfusion response . With HLA typing and negative lymphocytotoxicity crossmatches , 35 % of the platelet transfusions administered to 15 patients gave disappointing results ( 29 of 82 ) . Additional crossmatching with the newly developed platelet fluorescence test described in this paper reduced the unexpected transfusion failures to 7 % ( 6 of 82 ) . Five of these failures were observed in one patient . The target of the antibodies detected with this platelet fluorescence test is not yet fully specified . It seems probable that both HLA and platelet-specific non-HLA antibodies were detected . No correlation of the results of platelet transfusions with the presence or absence of leukoagglutinating antibodies was found A variety of patient and product-related factors influenced the outcome of 6379 transfusions given to 533 patients in the Trial to Reduce Alloimmunization to Platelets ( TRAP ) . Responses measured were platelet increments , interval between platelet transfusions , and platelet refractoriness . Patient factors that improved platelet responses were splenectomy and increasing patient age . In contrast , at least 2 prior pregnancies , male gender , splenomegaly , bleeding , fever , infection , disseminated intravascular coagulation , increasing height and weight , lymphocytotoxic antibody positivity , an increasing number of platelet transfusions , or receiving heparin or amphotericin were associated with decreased posttransfusion platelet responses . Platelet factors that were associated with improved platelet responses were giving ABO-compatible platelets , platelets stored for 48 hours or less , and giving large doses of platelets while ultraviolet B ( UV-B ) or gamma irradiation decreased platelet responses . However , in alloimmunized lymphocytoxic antibody-positive patients , the immediate increment to UV-B-irradiated platelets was well maintained , whereas all other products showed substantial reductions . Refractoriness to platelet transfusions developed in 27 % of the patients . Platelet refractoriness was associated with lymphocytotoxic antibody positivity , heparin administration , fever , bleeding , increasing number of platelet transfusions , increasing weight , at least 2 pregnancies , and male gender . The only factors that reduced platelet refractoriness rates were increasing the dose of platelets transfused or transfusing filtered apheresis platelets R and omized controlled trials have shown a reduction in platelet alloimmunization and refractoriness in patients with acute leukemia ( AL ) with the use of poststorage leukoreduction of blood products . Universal prestorage leukoreduction ( ULR ) of red cell and platelet products has been performed in Canada since August 1999 . We conducted a retrospective analysis of 13 902 platelet transfusions in 617 patients undergoing chemotherapy ( CT ) for AL or stem cell transplantation ( SCT ) before ( n = 315 ) and after ( n = 302 ) the introduction of ULR . Alloimmunization was significantly reduced ( 19 % to 7 % , P < .001 ) in the post-ULR group . Alloimmune platelet refractoriness was similarly reduced ( 14 % to 4 % , P < .001 ) . Fewer patients in the post-ULR group received HLA-matched platelets ( 14 % vs 5 % , P < .001 ) . Alloimmunization and alloimmune refractoriness in the 318 patients who were previously pregnant and /or transfused were also reduced after ULR ( P = .023 and P = .005 , respectively ) . In a Cox regression model , the 3 independent factors that predicted for alloimmune refractoriness were nonleukoreduced blood products ( relative risk [ RR ] , 2.2 [ 95 % CI , 1.2 - 4.3 ] ) , a history of pregnancy and /or transfusion ( RR , 2.3 [ 95 % CI , 1.3 - 4.2 ] ) , and receipt of 13 or more platelet transfusions ( RR , 6.0 [ 95 % CI , 2.4 - 15.3 ] ) . In conclusion , ULR reduces alloimmunization , refractoriness , and requirements for HLA-matched platelets when applied as routine transfusion practice to patients receiving CT or SCT Four platelet compatibility assays were performed on serum and platelet or lymphocyte sample s from 38 closely HLA-matched donor/recipient pairs involved in 55 single-donor platelet transfusions . The 22 patients studied were refractory to transfusions of pooled r and om-donor platelets . Of the four assays ( platelet suspension immunofluorescence , PSIFT ; 51Cr release ; microlymphocytotoxicity ; and a monoclonal anti-IgG assay , MAIA ) , the MAIA was most predictive of platelet transfusion outcome ( predictability , 74 % for one-hour posttransfusion platelet recovery and 76 % for 24-hour recovery ) . The only other assay to reach statistical significance was the PSIFT ( 63 % predictability for one-hour posttransfusion recovery ) . The degree of HLA compatibility between donor and recipient ( exact matches v those utilizing cross-reactive associations ) was unrelated to the ability of the MAIA to predict transfusion results . The MAIA may be capable of differentiating HLA antibodies , ABO antibodies , and platelet-specific antibodies responsible for failure of HLA-matched and selectively mismatched single-donor platelet transfusions BACKGROUND HLA-matched platelets and crossmatch-compatible platelets are used to support thrombocytopenic patients who are refractory to r and omly selected platelets . Data supporting the effectiveness of crossmatch-compatible platelets are limited , being essentially restricted to the subset of refractory patients previously shown to be alloimmunized . The authors ' hospital does not test for alloimmunization . To determine the effectiveness of crossmatch-compatible platelets in an unselected group of refractory patients , the use of such platelets for all patients who are refractory to r and om-donor platelets was review ed . STUDY DESIGN AND METHODS All patients who received crossmatch-compatible platelets between January 1991 and May 1994 were retrospectively review ed . All study patients were refractory to r and om-donor platelets , having two consecutive corrected count increments ( CCIs ) of < 10,000 . A solid-phase red cell adherence method was used for platelet crossmatching , and CCI was used to monitor the effectiveness of each platelet transfusion . RESULTS A total of 475 crossmatch-compatible platelet components were administered to 66 evaluable patients who were refractory to r and om-donor platelets . A significant improvement was found in the mean CCI when crossmatch-compatible platelets were compared with r and omly selected platelets ( p < 0.0001 ) : an increase of 8000 + /- 6100 ( mean + /- SD ) . In 59 percent ( 39/ 66 ) of the patients , the mean CCI improved to at least 7,500 and in 41 percent ( 27/66 ) to at least 10,000 . If the 10 patients for whom crossmatch-compatible platelets were not identified are included , the mean CCI in 51 percent ( 37/76 ) of the refractory patients improved to at least 7,500 ; in 36 percent ( 27/76 ) , it improved to at least 10,000 . The effectiveness of crossmatch-compatible platelets did not decline with continued use . CONCLUSION Crossmatch-compatible platelet components significantly improve the mean CCI for approximately one-half of patients who are refractory to r and om-donor platelets , even when the patients are not preselected for having alloimmunization to explain their refractory state BACKGROUND The use of crossmatch-compatible platelets ( PLTs ) improves posttransfusion corrected count increments ( CCIs ) in patients with alloimmune PLT refractoriness . However , few reports address the efficacy of utilizing this strategy for patients requiring intensive PLT transfusion therapy lasting several weeks to months . STUDY DESIGN AND METHODS Medical records of patients with two or more PLT crossmatch assays performed between 2002 and 2010 were review ed . All patients were refractory to r and om single-donor apheresis PLT units , defined as two consecutive 1-hour posttransfusion CCIs of less than 7500 . A commercial solid-phase adherence assay was used for crossmatching . RESULTS Seventy-one patients were included . A median of four crossmatch assays were performed per patient ( range , 2 - 17 ) . Mean percent reactivity in initial ( 58.6 % ) versus last ( 55.3 % ) crossmatch assay for each patient demonstrated no trend toward progressive alloimmunization ( p = NS ) . A total of 738 crossmatched PLT units were administered with a mean ± st and ard deviation CCI of 7000 ± 7900 ( n = 443 units with adequate 1-hr posttransfusion counts ) , a significant improvement over r and om PLTs ( p < 0.001 ) . Patients with an initial crossmatch reactivity of greater than 66 % were significantly more likely to demonstrate at least one panreactive crossmatch assay , impacting the availability of compatible PLTs for optimum transfusion support . One patient ( 1.4 % ) developed WHO Grade IV bleeding . CONCLUSIONS Progressive alloimmunization to mismatched antigens does not impact medium-term transfusion support with crossmatched PLTs . Increased reactivity in the initial crossmatch assay can serve as a trigger to initiate workup for HLA-matched PLTs as a second-line approach . However , for most patients , medium-term transfusion support with crossmatched PLTs offers an effective and rapid first-line approach to management of PLT transfusion refractoriness Despite the use of HLA-matched platelets for alloimmunized recipients , transfusion failures occur . In order to reduce these failures , we investigated the use of a radi
Output:
| No trend was observed regarding relative utility of the various commonly employed techniques .
Cross-matched PLTs are useful in increasing PLT counts in alloimmunized , transfusion-refractory HT patients , but data about their impact on hemorrhage and mortality are lacking |
MS210977 | ***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: Relationships between depression , alcohol and illicit drug use , adherence behaviors , and blood pressure ( BP ) were examined in 190 urban hypertensive Black men enrolled in an ongoing hypertension control clinical trial . More than one fourth ( 27.4 % ) of the sample scored greater than 16 on the Center for Epidemiological Studies - Depression Scale ( CES-D ) , indicating a high risk of clinical depression . Depression was significantly associated with an increased likelihood of meeting Diagnostic and Statistical Manual of Mental Disorders ( 4th ed . ) criteria for alcohol abuse or dependence ( odds ratio = 5.2 ; 95 % confidence interval = 1.897–14.214 ) . The level of depression was significantly correlated with poor medication ( r = .301 ) and poor dietary compliance ( r = .164 ) . Both alcohol intake and illicit drug use were significantly correlated with poor dietary compliance ( r = .195 and .185 , respectively ) and smoking ( r = .190 and .269 , respectively ) . Although no direct relationship between depression and the level of BP was substantiated by multivariate analysis , findings of descriptive analyses revealed statistically significant associations among depression , substance use , poor adherence , and poor BP outcomes . Given the harsh environment in which a large number of young urban Black men live , the high prevalence of substance abuse might be an attempt to fight off depression . Further in- depth investigation is needed to identify the role of depression and BP control in urban young Blacks in order to construct effective interventions that address their unique needs BACKGROUND The prevalence , morbidity and mortality of hypertension are strikingly higher for African Americans than for Whites . Poor adherence to the antihypertensive medication regimen is a major cause of inadequate blood pressure control . In this study , we assess the relationship of antihypertensive medication adherence to sociodemographic , clinical and cognitive characteristics of urban African American adults . METHOD Data were drawn from a larger r and omized controlled trial assessing the effect of a behavioral intervention to improve medication adherence and blood pressure control among hypertensive African American patients followed in an urban primary care network . Medication adherence was assessed at baseline using the Medication Event Monitoring System (MEMS)--a method regarded as the gold st and ard for assessing medication adherence in clinical research . Information on potential correlates of medication adherence ( sociodemographic , clinical and cognitive ) was obtained at baseline by computer-assisted interview . We assessed the cross sectional association of these factors to medication adherence in baseline data . RESULTS Medication adherence was significantly associated with systolic blood pressure ( r=.253 , P<.04 ) and self-reported medication adherence ( r=.285 , P<.03 ) . The relationship of education to medication adherence varied significantly by sex ( P<.05 for interaction ) . Specifically , lower educational attainment was related to higher adherence among men , but lower adherence among women . CONCLUSION Identifying correlates of low antihypertensive medication adherence and their interactions , as in this study , will help health providers to better recognize patients at higher risk for worse hypertension-related outcomes . This knowledge can also inform interventions which target a higher-risk subset of hypertensive patients Barriers to high blood pressure ( HBP ) care and control have been reported in the literature for > 30 years . Few reports on barriers , however , have focused on the young black man with HBP , the age/sex/race group with the highest rates of early severe and complicated HBP and the lowest rates of awareness , treatment , and control . In a r and omized clinical trial of comprehensive care for hypertensive young urban black men , factors potentially associated with care and control were assessed at baseline for the 309 enrolled men . A majority of the men encountered a variety of barriers including economic , social , and lifestyle obstacles to adequate BP care and control , including no current HBP care ( 49 % ) , risk of alcoholism ( 62 % ) , use of illicit drugs ( 45 % ) , social isolation ( 47 % ) , unemployment ( 40 % ) , and lack of health insurance ( 51 % ) . Having health insurance ( odds ratio = 7.20 , P = .00 ) and a negative urine drug screen ( odds ratio = .56 , P = .04 ) were significant predictors of being in HBP care . Low alcoholism risk and employment were identified as significant predictors of compliance with HBP medication-taking behavior . Men currently using illicit drugs were 2.64 times less likely to have controlled BP compared with their counterparts who did not use illicit drugs , and men currently taking HBP medication were 63 times more likely have controlled BP compared with men not taking HBP medication . Comprehensive interventions are needed to address socioeconomic and lifestyle issues as well as other barriers to care and treatment , if HBP care is to be salient and effective in this high risk group Many studies have documented the negative effects of depression on adherence to recommended treatment ; however , little is known about the mechanism underlying this relationship . Using the Kenny and Baron analytic framework of mediation , the authors assessed whether self-efficacy mediated the relationship between depression and medication adherence in 167 hypertensive African Americans followed in a primary care practice . Depressive symptoms are associated with poor medication adherence ( β = .013 , p = .036 ) and low self-efficacy ( β = —.008 , p = .023 ) . Self-efficacy is negatively associated with medication adherence at follow-up ( β = —.612 , p < .001 ) . The relationship between depressive symptoms and medication adherence becomes nonsignificant when controlling for self-efficacy ( β = .010 , p = .087 ) . Implication s for further examination into the mediating role of self-efficacy and the deleterious effect of depression on medication adherence are discussed BACKGROUND Poor medication adherence is a significant problem in hypertensive African Americans . Although motivational interviewing ( MINT ) is effective for adoption and maintenance of health behaviors in patients with chronic diseases , its effect on medication adherence remains untested in this population . METHODS This r and omized controlled trial tested the effect of a practice -based MINT counseling vs. usual care ( UC ) on medication adherence and blood pressure ( BP ) in 190 hypertensive African Americans ( 88 % women ; mean age 54 years ) . Patients were recruited from two community-based primary care practice s in New York City . The primary outcome was adherence measured by electronic pill monitors ; the secondary outcome was within-patient change in office BP from baseline to 12 months . RESULTS Baseline adherence was similar in both groups ( 56.2 and 56.6 % for MINT and UC , respectively , P = 0.94 ) . Based on intent-to-treat analysis using mixed-effects regression , a significant time x group interaction with model-predicted posttreatment adherence rates of 43 and 57 % were found in the UC and MINT groups , respectively ( P = 0.027 ) , with a between-group difference of 14 % ( 95 % confidence interval , -0.2 to -27 % ) . The between-group difference in systolic and diastolic BP was -6.1 mm Hg ( P = 0.065 ) and -1.4 mm Hg ( P = 0.465 ) , respectively , in favor of the MINT group . CONCLUSIONS A practice -based MINT counseling led to steady maintenance of medication adherence over time , compared to significant decline in adherence for UC patients . This effect was associated with a modest , nonsignificant trend toward a net reduction in systolic BP in favor of the MINT group
Output:
| Factors that were associated with medication adherence were self-efficacy , depression , patient-provider communication , and healthcare system related . |
MS210978 | ***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 data about the safety of vaginal birth after caesarean section are conflicting . This study in a referral hospital in Sana'a , Yemen investigated the outcome of vaginal birth after caesarean section in 357 women who had one prior caesarean section and were admitted to hospital at term with spontaneous onset of labour . A control group ( n = 155 ) was matched from women without previous caesarean section . The success rate of vaginal birth after caesarean section was 311/357 ( 87.1 % ) . The mean duration of the first and second stages of labour were not significantly different in the study group ( 146.2 and 30.7 min respectively ) compared with the control group ( 146.7 and 29.8 min ) . There were infrequent complications ; only 1 woman ( 0.3 % ) had ruptured uterus and 3 women ( 1.0 % ) suffered uterine dehiscence . There was 1 stillbirth after the uterine rupture but no maternal deaths Objective To assess the risks and benefits associated with caesarean delivery compared with vaginal delivery . Design Prospect i ve cohort study within the 2005 WHO global survey on maternal and perinatal health . Setting 410 health facilities in 24 areas in eight r and omly selected Latin American countries ; 123 were r and omly selected and 120 participated and provided data Participants 106 546 deliveries reported during the three month study period , with data available for 97 095 ( 91 % coverage ) . Main outcome measures Maternal , fetal , and neonatal morbidity and mortality associated with intrapartum or elective caesarean delivery , adjusted for clinical , demographic , pregnancy , and institutional characteristics . Results Women undergoing caesarean delivery had an increased risk of severe maternal morbidity compared with women undergoing vaginal delivery ( odds ratio 2.0 ( 95 % confidence interval 1.6 to 2.5 ) for intrapartum caesarean and 2.3 ( 1.7 to 3.1 ) for elective caesarean ) . The risk of antibiotic treatment after delivery for women having either type of caesarean was five times that of women having vaginal deliveries . With cephalic presentation , there was a trend towards a reduced odds ratio for fetal death with elective caesarean , after adjustment for possible confounding variables and gestational age ( 0.7 , 0.4 to 1.0 ) . With breech presentation , caesarean delivery had a large protective effect for fetal death . With cephalic presentation , however , independent of possible confounding variables and gestational age , intrapartum and elective caesarean increased the risk for a stay of seven or more days in neonatal intensive care ( 2.1 ( 1.8 to 2.6 ) and 1.9 ( 1.6 to 2.3 ) , respectively ) and the risk of neonatal mortality up to hospital discharge ( 1.7 ( 1.3 to 2.2 ) and 1.9 ( 1.5 to 2.6 ) , respectively ) , which remained higher even after exclusion of all caesarean deliveries for fetal distress . Such increased risk was not seen for breech presentation . Lack of labour was a risk factor for a stay of seven or more days in neonatal intensive care and neonatal mortality up to hospital discharge for babies delivered by elective caesarean delivery , but rupturing of membranes may be protective . Conclusions Caesarean delivery independently reduces overall risk in breech presentations and risk of intrapartum fetal death in cephalic presentations but increases the risk of severe maternal and neonatal morbidity and mortality in cephalic presentations A r and omized controlled trial with 76 physicians in 16 community hospitals evaluated audit and feedback and local opinion leader education as methods of encouraging compliance with a guideline for the management of women with a previous cesarean section . The guideline recommended clinical actions to increase trial of labor and vaginal birth rates . Charts for all 3552 cases in the study groups were audited . After 24 months the trial of labor and vaginal birth rates in the audit and feedback group were no different from those in the control group , but rates were 46 % and 85 % higher , respectively , among physicians educated by an opinion leader . Duration of hospital stay was lower in the opinion leader education group than in the other two groups . The overall cesarean section rate was reduced only in the opinion leader education group . There were no adverse clinical outcomes attributable to the interventions . The use of opinion leaders improved the quality of care Objective To determine whether antepartum X‐ray pelvimetry ( XRP ) reliably identified women suitable for a trial labour or repeat elective caesarean section after one previous section In response to a Western Australian Ministerial enquiry into the levels of intervention in childbirth , a 2‐year prospect i ve audit was undertaken of the indication and timing of all public Caesarean section deliveries at King Edward Memorial hospital . During the study period , a total of 9,138 deliveries were performed at the hospital , of which 1,624 were by Caesarean section , an overall rate of 17.8 % . Of these , 633 ( 39 % ) were elective and 911 ( 61 % ) were nonelective . The most common primary indication for elective Caesarean section was maternal choice , largely due to a refusal of the patient to consent to a trial of scar following a single previous Caesarean section or a refusal to attempt a trial of vaginal breech delivery . The most common indications for nonelective Caesarean section birth were an intrapartum diagnosis of suspected fetal distress or failure to progress in labour . Strategies to reduce the incidence of Caesarean section birth need to focus on the pathways involved with maternal decision‐making in the birth process , and on improving the diagnosis of intrapartum fetal compromise
Output:
| The use of external peer review , audit and feedback had no significant effect on VBAC rates .
An educational strategy delivered by an opinion leader significantly increased VBAC rates .
The use of XRP significantly increased CS rates .
An opinion leader educational strategy confers benefit for increasing VBAC rates . |
MS210979 | ***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: Marked improvement in glycemic control occurs in patients with type 2 diabetes mellitus shortly after Roux-en-Y gastric bypass surgery ( RYGB ) and before there is major weight loss . The objective of this study was to determine whether the magnitude of this change is primarily due to caloric restriction or is unique to the surgical procedure . We studied eleven subjects who underwent RYGB and fourteen subjects mean-matched for BMI , HbA1c , and diabetes duration who were admitted to our inpatient research unit and given a very low – calorie diet ( VLCD ) of 500 kcal/day with a macronutrient content similar to that consumed by patients after RYGB . Frequently sample d intravenous glucose tolerance tests were performed before and after interventions . Both groups lost an equivalent amount of weight over a mean study period of 21 days . Insulin sensitivity , acute insulin secretion after intravenous glucose administration , and β-cell function as determined by disposition index improved to a similar extent in both groups . Likewise , changes in fasting glucose and fructosamine levels were similar . Based on these data , VLCD improves insulin sensitivity and β-cell function just as well as RYGB in the short term Although moderate weight loss improves glycemic control in obese NIDDM patients , quite often it is not normalized . To determine whether the response to weight loss can be improved by altering the macronutrient composition of hypocaloric diets , 17 obese NIDDM patients were studied at 1 ) baseline , 2 ) after dieting for 6 weeks on a formula diet enriched in either monounsaturated fatty acids ( MUFAs , n = 9 ) or carbohydrates ( CHOs , n = 8) at a 50 % caloric deficit , and 3 ) after 4 weeks of postdiet refeeding on the respective formulas with caloric intake titrated to achieve weight maintenance . Fasting , 24-h , and oral glucose tolerance test ( OGTT ) blood glucose , plasma insulin , and C-peptide levels were measured . All prediet parameters were similar between groups . After dieting , although weight loss was similar between groups , the fasting glucose level decreased significantly more in the MUFA group ( −4.6 ± 0.7 mmol/l ) than in the CHO group ( −2.4 ± 1.0 mmol/l ; P < 0.05 ) . Twenty-four – hour glycemia decreased in both groups after dieting , but the MUFA group had a greater decrease than the CHO group ( P < 0.05 , analysis of variance [ ANOVA ] ) . Although decreases in fasting glycemia were maintained in both groups after refeeding , postpr and ial glycemia deteriorated after refeeding with the CHO- but not the MUFA-enriched formula ( P < 0.05 ) . After dieting and refeeding , fasting C-peptide increased 204 ± 47 pmol/l in the MUFA group , but the CHO group remained at prediet levels ( P < 0.05 ) . Twenty-four-hour C-peptide levels were similar between groups after dieting and refeeding , despite the lower glycemia and CHO content of the MUFA formula . However , when equal amounts of CHO were consumed during the OGTT , the MUFA group had significantly higher C-peptide levels after both dieting and refeeding ( P < 0.05 ) . Fasting , 24-h , and OGTT insulin levels were similar between groups throughout the study . These results indicate that macronutrient composition is an important determinant of the glycemic response to weight-loss therapy in obese NIDDM patients . Based on the C-peptide response during the OGTT , increased CHO-induced insulin secretion is one possible mechanism by which this occurs There has been interest in the effect of various types and amounts of dietary carbohydrates and proteins on blood glucose . On the basis of our previous data , we design ed a high-protein/low-carbohydrate , weight-maintaining , nonketogenic diet . Its effect on glucose control in people with untreated type 2 diabetes was determined . We refer to this as a low-biologically-available-glucose ( LoBAG ) diet . Eight men were studied using a r and omized 5-week crossover design with a 5-week washout period . The carbohydrate : protein : fat ratio of the control diet was 55:15:30 . The test diet ratio was 20:30:50 . Plasma and urinary beta-hydroxybutyrate were similar on both diets . The mean 24-h integrated serum glucose at the end of the control and LoBAG diets was 198 and 126 mg/dl , respectively . The percentage of glycohemoglobin was 9.8 + /- 0.5 and 7.6 + /- 0.3 , respectively . It was still decreasing at the end of the LoBAG diet . Thus , the final calculated glycohemoglobin was estimated to be approximately 6.3 - 5.4 % . Serum insulin was decreased , and plasma glucagon was increased . Serum cholesterol was unchanged . Thus , a LoBAG diet ingested for 5 weeks dramatically reduced the circulating glucose concentration in people with untreated type 2 diabetes . Potentially , this could be a patient-empowering way to ameliorate hyperglycemia without pharmacological intervention . The long-term effects of such a diet remain to be determined Rapid glycemic improvements following Roux-en-Y gastric bypass ( RYGB ) are frequently attributed to the enhanced GLP-1 response , but causality remains unclear . To determine the role of GLP-1 in improved glucose tolerance after surgery , we compared glucose and hormonal responses to a liquid meal test in 20 obese participants with type 2 diabetes mellitus who underwent RYGB or nonsurgical intensive lifestyle modification ( ILM ) ( n = 10 per group ) before and after equivalent short-term weight reduction . The GLP-1 receptor antagonist exendin(9–39)-amide ( Ex-9 ) was administered , in r and om order and in double-blinded fashion , with saline during two separate visits after equivalent weight loss . Despite the markedly exaggerated GLP-1 response after RYGB , changes in postpr and ial glucose and insulin responses did not significantly differ between groups , and glucagon secretion was paradoxically augmented after RYGB . Hepatic insulin sensitivity also increased significantly after RYGB . With Ex-9 , glucose tolerance deteriorated similarly from the saline condition in both groups , but postpr and ial insulin release was markedly attenuated after RYGB compared with ILM . GLP-1 exerts important insulinotropic effects after RYGB and ILM , but the enhanced incretin response plays a limited role in improved glycemia shortly after surgery . Instead , enhanced hepatic metabolism , independent of GLP-1 receptor activation , may be more important for early postsurgical glycemic improvements BACKGROUND Biliopancreatic diversion ( BPD ) is the most effective bariatric procedure in terms of weight loss and remission of diabetes type 2 ( T2DM ) , but it is accompanied by nutrient deficiencies . Sleeve gastrectomy ( SG ) is a relatively new operation that has shown promising results concerning T2DM resolution and weight loss . The objective of this study was to evaluate and compare prospect ively the effects of BPD long limb ( BPD ) and laparoscopic SG on fasting , and glucose-stimulated insulin , glucagon , ghrelin , peptide YY ( PYY ) , and glucagon-like peptide-1 ( GLP-1 ) secretion and also on remission of T2DM , hypertension , and dyslipidemia in morbidly obese patients with T2DM . METHODS Twelve patients ( body mass index [ BMI ] 57.6 ± 9.9 kg/m(2 ) ) underwent BPD and 12 ( BMI 43.7 ± 2.1 kg/m(2 ) ) underwent SG . All patients had T2DM and underwent an oral glucose tolerance test ( OGTT ) before and 1 , 3 , and 12 months after surgery . RESULTS BMI decreased more after BPD , but percent excess weight loss ( % EWL ) was similar in both groups ( P = .8 ) and T2DM resolved in all patients at 12 months . Insulin sensitivity improved more after BPD than after SG ( P = .003 ) . Blood pressure , total and LDL cholesterol decreased only after BPD ( P<.001 ) . Triglycerides decreased after either operation , but HDL increased only after SG ( P<.001 ) . Fasting ghrelin did not change after BPD ( P = .2 ) , but decreased markedly after SG ( P<.001 ) . GLP-1 and PYY responses during OGTT were dramatically enhanced after either procedure ( P = .001 ) . CONCLUSIONS SG was comparable to BPD in T2DM resolution but inferior in improving dyslipidemia and blood pressure . SG and BPD enhanced markedly PYY and GLP-1 responses but only SG suppressed ghrelin levels BACKGROUND Type 2 diabetes mellitus is increasingly common , primarily because of increases in the prevalence of a sedentary lifestyle and obesity . Whether type 2 diabetes can be prevented by interventions that affect the lifestyles of subjects at high risk for the disease is not known . METHODS We r and omly assigned 522 middle-aged , overweight subjects ( 172 men and 350 women ; mean age , 55 years ; mean body-mass index [ weight in kilograms divided by the square of the height in meters ] , 31 ) with impaired glucose tolerance to either the intervention group or the control group . Each subject in the intervention group received individualized counseling aim ed at reducing weight , total intake of fat , and intake of saturated fat and increasing intake of fiber and physical activity . An oral glucose-tolerance test was performed annually ; the diagnosis of diabetes was confirmed by a second test . The mean duration of follow-up was 3.2 years . RESULTS The mean ( + /-SD ) amount of weight lost between base line and the end of year 1 was 4.2+/-5.1 kg in the intervention group and 0.8+/-3.7 kg in the control group ; the net loss by the end of year 2 was 3.5+/-5.5 kg in the intervention group and 0.8+/-4.4 kg in the control group ( P<0.001 for both comparisons between the groups ) . The cumulative incidence of diabetes after four years was 11 percent ( 95 percent confidence interval , 6 to 15 percent ) in the intervention group and 23 percent ( 95 percent confidence interval , 17 to 29 percent ) in the control group . During the trial , the risk of diabetes was reduced by 58 percent ( P<0.001 ) in the intervention group . The reduction in the incidence of diabetes was directly associated with changes in lifestyle . CONCLUSIONS Type 2 diabetes can be prevented by changes in the lifestyles of high-risk subjects OBJECTIVE Hyperglycemia improves when patients with type 2 diabetes are placed on a weight-loss diet . Improvement typically occurs soon after diet implementation . This rapid response could result from low fuel supply ( calories ) , lower carbohydrate content of the weight-loss diet , and /or weight loss per se . To differentiate these effects , glucose , insulin , C-peptide and glucagon were determined during the last 24 h of a 3-day period without food ( severe calorie restriction ) and a calorie-sufficient , carbohydrate-free diet . RESEARCH DESIGN Seven subjects with untreated type 2 diabetes were studied . A r and omized-crossover design with a 4-week washout period between arms was used . METHODS Results from both the calorie-sufficient , carbohydrate-free diet and the 3-day fast were compared with the initial st and ard diet consisting of 55 % carbohydrate , 15 % protein and 30 % fat . RESULTS The overnight fasting glucose concentration decreased from 196 ( st and ard diet ) to 160 ( carbohydrate-free diet ) to 127 mg/dl ( fasting ) . The 24 h glucose and insulin area responses decreased by 35 % and 48 % on day 3 of the carbohydrate-free diet , and by 49 % and 69 % after fasting . Overnight basal insulin and glucagon remained unchanged . CONCLUSIONS Short-term fasting dramatically lowered overnight fasting and 24 h integrated glucose concentrations . Carbohydrate restriction per se could account for 71 % of the reduction . Insulin could not entirely explain the glucose responses . In the absence of carbohydrate , the net insulin response was 28 % of the st and ard diet . Glucagon did not contribute to the metabolic adaptations observed Objective : To evaluate the physiologic importance of the satiety gut hormones . Background : Controversy surrounds the physiologic role of gut hormones in the control of appetite . Bariatric surgery remains the most effective treatment option for obesity , and gut hormones are implicated in the reduction of appetite and weight after Roux-en-Y gastric bypass . Methods : We correlated peptide YY ( PYY ) and glucagon-like pe
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| Conclusions Synergistic suppression of fasting glucagon and insulin resistance may act together to restore normoglycaemia following weight loss .
Whether suppression of plasma glucagon may contribute to increased hunger after weight loss and gradual weight regain is not yet known |
MS210980 | ***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 : To evaluate the use of a computerised support system for decision making for implementing evidence based clinical guidelines for the management of asthma and angina in adults in primary care . Design : A before and after pragmatic cluster r and omised controlled trial utilising a two by two incomplete block design . Setting : 60 general practice s in north east Engl and . Participants : General practitioners and practice nurses in the study practice s and their patients aged 18 or over with angina or asthma . Main outcome measures : Adherence to the guidelines , based on review of case notes and patient reported generic and condition specific outcome measures . Results : The computerised decision support system had no significant effect on consultation rates , process of care measures ( including prescribing ) , or any patient reported outcomes for either condition . Levels of use of the software were low . Conclusions : No effect was found of computerised evidence based guidelines on the management of asthma or angina in adults in primary care . This was probably due to low levels of use of the software , despite the system being optimised as far as was technically possible . Even if the technical problems of producing a system that fully supports the management of chronic disease were solved , there remains the challenge of integrating the systems into clinical encounters where busy practitioners manage patients with complex , multiple conditions We developed a computer-stored medical record system containing a limited set of the total clinical data base -- primarily diagnostic studies and treatments . This system responds to its own content according to physician-authored reminder rules . To determine the effect of the reminder messages generated by 1490 rules on physician behavior , we r and omly assigned practitioners in a general medicine clinic to study or control groups . The computer found indications for six different actions per patient in 12 467 patients during a 2-year study : 61 study group residents who received computer reminders responded to 49 % of these indications ; 54 control group residents , to only 29 % ( p less than 0.0001 ) . Preventive care ( occult blood testing , mammographic screening , weight reduction diets , influenza and pneumococcal vaccines ) was affected . The intentions of the study group to use a given action for an indication predicted their response to the indications ( p less than 0.03 , r2 = 0.33 ) . The intentions of the control residents did not To determine whether clinical errors can be reduced by prospect i ve computer suggestions about the management of simple clinical events , I studied the responses of nine physicians to computer suggestions generated by 390 protocol s in a controlled crossover design . These protocol s dealt primarily with conditions managed ( e.g. , elevated blood pressure ) or caused ( e.g. , liver toxicity ) by drugs . Physicians responded to 51 per cent of 327 events when given , and 22 per cent of 385 events when not given computer suggestions . Neither level of postgraduate training ( first-year postgraduate or third-year post-graduate ) nor the order in which physicians served as study and control subjects had statistically significant overall effect on the results . It appears that the prospect i ve reminders do reduce errors , and that many of these errors are probably due to man 's limitations as a data processor rather than to correctable human deficiencies OBJECTIVE —The purpose of this study was to determine whether implementation of a multicomponent organizational intervention can produce significant change in diabetes care and outcomes in community primary care practice s. RESEARCH DESIGN AND METHODS —This was a group-r and omized , controlled clinical trial evaluating the practical effectiveness of a multicomponent intervention ( TRANSLATE ) in 24 practice s. The intervention included implementation of an electronic diabetes registry , visit reminders , and patient-specific physician alerts . A site coordinator facilitated previsit planning and a monthly review of performance with a local physician champion . The principle outcomes were the percentage of patients achieving target values for the composite of systolic blood pressure ( SBP ) < 130 mmHg , LDL cholesterol < 100 mg/dl , and A1C < 7.0 % at baseline and 12 months . Six process measures were also followed . RESULTS —Over 24 months , 69,965 visits from 8,405 adult patients with type 2 diabetes were recorded from 238 health care providers in 24 practice s from 17 health systems . Diabetes process measures increased significantly more in intervention than in control practice s , giving net increases as follows : foot examinations 35.0 % ( P < 0.0.001 ) ; annual eye examinations 25.9 % ( P < 0.001 ) ; renal testing 28.5 % ( P < 0.001 ) ; A1C testing 8.1%(P < 0.001 ) ; blood pressure monitoring 3.5 % ( P = 0.05 ) ; and LDL testing 8.6 % ( P < 0.001 ) . Mean A1C adjusted for age , sex , and comorbidity decreased significantly in intervention practice s ( P < 0.02 ) . At 12 months , intervention practice s had significantly greater improvement in achieving recommended clinical values for SBP , A1C , and LDL than control clinics ( P = 0.002 ) . CONCLUSIONS — Introduction of a multicomponent organizational intervention in the primary care setting significantly increases the percentage of type 2 diabetic patients achieving recommended clinical outcomes Purpose : Physicians and patients frequently miss opportunities to improve the quality of care of diabetes , primarily because of the complexity of managing many risk factors over many years with many other providers . Electronic decision support is a potential way to improve prescribing and quality of care . Shared care , meaning patients and physicians sharing access to the patient ’s status compared to recommended targets , is thought to improve outcomes as are supportive reminders . Our objective was to rigorously evaluate whether an electronic medical record (EMR)-linked , individualized electronic diabetes tracker with automated telephone reminders could improve the quality of diabetes management in primary care . Methods : Community-based family physicians across Ontario who were already using EMRs in their practice , were recruited . Patient and physician versions of a Web-based diabetes tracker , the ( COMPETE II Diabetes Tracker ( CIIDT ) system , were developed . The main tracker page showed all 13 monitoring variables – the patient ’s recent values , both process ( when last checked ) and outcome ( the result ) , target values for process and outcome , and short advisory messages , with red/yellow/green highlighting to indicate urgency of review . Links to best evidence guidelines and patient re sources were provided . The physician view appeared as an overlay in a corner of their own electronic medical record ( N = 6 EMR products ) . Intervention patients were linked to a voice biometric-enabled automated telephone reminder system ( ATRS ) for medications , labs and visits . Consenting patients with diabetes were r and omized to the CIIDT-ATRS intervention or usual care ( neither ) . Since the study was relatively short ( 6 months follow-up ) , the primary outcome was a composite score of process quality – the quality of monitoring the variables compared to target . Secondary outcomes included clinical outcomes plus evaluations of the tracker and ATRS , and impact on health information privacy . Results : Forty-eight physicians ( mean age ( SD ) = 45.2 ( 10.0 ) , 38.2 % female ) were recruited and 511 patients ( mean age ( SD ) = 60.3 ( 12.4 ) , 49.6 % female , 78 % completed high school ) were r and omized . Only 46.1 % of patients used the Internet at least monthly so print versions of their recent information were sent to them prior to their physician visits . There were frequent technical problems with the Web-based tracker and a lack of data integration between the various EMRs and the tracker . Despite problems , the primary outcome of composite score of physician visits , and checks of blood pressure ( BP ) , LDL cholesterol , HbA1C , microalbuminuria , BMI , feet and eyes , showed a highly statistically significant improvement in the intervention group compared to control ( p<0.0001 ) . There were also highly statistically significant improvements in actual blood pressure ( -2.68 mm diastolic BP , p=0.007 ) and in HbA1C ( -.2 % , p=0.001 ) . 75.9 % of intervention patients were as satisfied or more satisfied with their care since the use of the tracker system and 62.5 % voted to continue to receive ATRS reminders . 22.4 % of patients felt that , in general , the risk of possible loss of confidentiality outweighed the benefits that computers could bring to their health . Over the course of the study , physicians developed a more favourable attitude towards the benefits vs risks of computerized systems in healthcare . Discussion : Despite considerable technical challenges for both patients and physicians , we have demonstrated that the care of a complex chronic disease can be improved with electronic tracking and decision support for both physician and patient . This is one of the first r and omized trial to demonstrate success in routine , community-based primary care . Funding Source : Grant from the Canada Health Infostructure Partnerships Program , Health Canada . References : 1 . Branger PJ . van't Hooft A. van der Wouden JC . Moorman PW . van Bemmel JH . Shared care for diabetes : supporting communication between primary and secondary care . International Journal of Medical Informatics 1999 ; 53:133 - 42 . 2 . Jerant AF . Hill DB . Does the use of electronic medical records improve surrogate patient outcomes in outpatient setting s ? Journal of Family Practice 2000;49:349 - 57 . * Dr Lee is deceased BACKGROUND A cluster r and omized trial of tailored interventions to support the implementation of guidelines for sore throat and urinary tract infection found little or no change in the main outcomes , which were antibiotic prescriptions , use of laboratory tests and use of telephone consultations . There was great variation between the practice s in the change in these outcomes . OBJECTIVES Our aim was to evaluate how the interventions were received and to underst and why practice s did or did not change . METHODS The trial was conducted in general practice s in Norway . Data for this process evaluation were collected from the 120 practice s that completed the trial . Multiple methods were used : observations , semi-structured telephone interviews , a postal survey and data extracted from electronic medical records . We investigated factors that might explain a lack of change , including : agreement with the guidelines ; communication within each practice ; degree of participation in the project ; taking time to discuss the guidelines and their implementation ; use of the components of the interventions ; and routines for telephone consultations . Possible explanatory factors were explored in relation to variation in change and the overall extent of change in rates of use of antibiotics , laboratory tests and telephone consultations . RESULTS Sixty-three per cent of practice s agreed with the guidelines . Only 35 % reported having regular meetings , and 33 % discussed the project before its start , although 75 % reported agreement about participating within the practice . Only 33 % reported meeting to discuss the guidelines . Use of the components of the interventions ranged from 11 % for the increased fee for telephone consultations to 48 % for the computerized decision support . Forty-four per cent reported problems with telephone routines . No single factor explained the observed variation in the extent of change across practice s. CONCLUSIONS Inadequate time , re sources and support were the most salient factors that might explain a lack of change . Problems with internal communication and telephone routines were important contributing factors in many practice OBJECTIVE To assess the effects on health care re source utilization of a network of microcomputer workstations for writing all inpatient orders . DESIGN R and omized controlled clinical trial . SETTING Inpatient internal medicine service of an urban public hospital . SUBJECTS A total of 5219 internal medicine patients and the 68 teams of house officers , medical students , and faculty internists who cared for them . INTERVENTION Microcomputer workstations , linked to a comprehensive electronic medical record system , for writing all inpatient orders . MAIN OUTCOME MEASURES Total inpatient charges for each admission and charges for specific categories of orders . A time-motion study of selected interns assessed the ordering system 's time consumption . RESULTS Intervention teams generated charges that were $ 887 ( 12.7 % ) lower per admission than did control teams ( P = .02 ) . Significant reductions ( P < .05 ) were demonstrated separately for bed charges , diagnostic test charges , and drug charges . Reductions of similar proportion and statistical significance were found for hospital costs . The mean length of stay was 0.89 day shorter for intervention resident teams ( P = .11 ) . Interns in the intervention group spent an average of 33 minutes longer ( 5.5 minutes per patient ) during a 10-hour observation period writing orders than did interns in the control group ( P < .0001 ) . CONCLUSIONS A network of microcomputer workstations for writing all inpatient orders significantly lowered patient charges and hospital costs . This would amount to savings of more than $ 3 million in charges annually for this hospital 's medicine service and potentially tens of billions of dollars nationwide . However , the system required more physician time than did the paper charts . Research at other sites and system advances to reduce time requirements are warranted Abstract Objective To test the effectiveness of educational interventions in improving detection rates and management of dementia in primary care . Design Unblinded , cluster r and omised , before and after controlled study . Setting General practice s in the United Kingdom ( central Scotl and and London ) between 1999 and 2002 . Interventions Three educational interventions : an electronic tutorial carried on a CD Rom ; decision support software built into the electronic medical record ; and practice based workshops . Participants 36 practice s participated in the study . Eight practice s were r and omly assigned to the electronic tutorial ; eight to decision support software ; 10 to practice based workshops ; and 10 to control . Electronic and manual search es yielded 450 valid and usable medical records . Main outcome measures Rates of detection of dementia and the extent to
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| Conclusions Some CCDSSs can modify practitioner test-ordering behavior . |
MS210981 | ***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: We have studied the effect of common mutations ( 677C-->T and 1298A-->C ) of the methylenetetrahydrofolate reductase ( MTHFR ) gene in sixty-six healthy French subjects , aged 27 - 47 years . Serum folate , vitamin B12 , and plasma total homocysteine were measured as well as the specific activity of MTHFR in lymphocytes . The frequency of subjects homozygous for the 677TT genotype was 18 % , and that of those homozygous for the 1298CC genotype was 12.5 % . The frequency of individuals heterozygous for both mutations was 23.5 % . The 1298A-->C mutation was associated with decreased MTHFR specific activity in subjects with both 677CC and 677CT genotypes . This activity was 60 % for the 677CC/1298AC genotype and 52 % for the 677CC/1298CC genotype when compared with the MTHFR specific activity of the 677CC/1298AA genotype . Heterozygotes for both mutations ( 677CT/1298AC genotype ) had 36 % of the reference specific activity . Although homocysteine levels in 677TT and 1298CC genotype subjects were higher than for other genotypes , no significant differences were observed among different genotypes . This may be due to high serum folate level in our sample s , and suggests that folate therapy may be useful to prevent hyperhomocysteinaemia in homozygous mutant subjects BACKGROUND Methylenetetrahydrofolate reductase ( MTHFR ; EC 1.7.99.5 ) supplies the folate needed for the metabolism of homocysteine . A reduction in MTHFR activity , as occurs in the homozygous state for the 677C-->T ( so-called thermolabile ) enzyme variant ( TT genotype ) , is associated with an increase in plasma total homocysteine ( tHcy ) . OBJECTIVE In vitro studies suggest that the reduced activity of thermolabile MTHFR is due to the inappropriate loss of its riboflavin cofactor . We investigated the hypothesis that MTHFR activity in the TT genotype group is particularly sensitive to riboflavin status . DESIGN We studied tHcy and relevant B-vitamin status by MTHFR genotype in a cross-sectional study of 286 healthy subjects aged 19 - 63 y ( median : 27 y ) . The effect of riboflavin status was examined by dividing the sample into tertiles of erythrocyte glutathionine reductase activation coefficient , a functional index of riboflavin status . RESULTS Lower red blood cell folate ( P = 0.0001 ) and higher tHcy ( P = 0.0082 ) concentrations were found in the TT group than in the heterozygous ( CT ) or wild-type ( CC ) groups . However , these expected relations in the total sample were driven by the TT group with the lowest riboflavin status , whose mean tHcy concentration ( 18.09 micromol/L ) was almost twice that of the CC or CT group . By contrast , adequate riboflavin status rendered the TT group neutral with respect to tHcy metabolism . CONCLUSIONS The high tHcy concentration typically associated with homozygosity for the 677C-->T variant of MTHFR occurs only with poor riboflavin status . This may have important implication s for governments considering new fortification policies aim ed at the prevention of diseases for which this genotype is associated with increased risk The effectiveness of additional food folate in improving folate status in humans is uncertain particularly in people with the common genetic variant ( 677 C-->T ) in the methylenetetrahydrofolate reductase ( MTHFR ) gene . To examine the effect of a doubling of food folate consumption on folate status response variables , women ( n=32 ; 18 - 46 years ) with the MTHFR 677 CC or TT genotype consumed either 400 ( n=15 ; 7 CC and 8 TT ) or 800 ( n=17 ; 8 CC and 9 TT ) microg/day of dietary folate equivalents ( DFE ) derived exclusively from naturally occurring food folate for 12 weeks . A repeated measures two-factor ANOVA was used to examine the effect of the dietary treatment , the MTHFR C677 T genotype and their interactions on serum folate , RBC folate and plasma total homocysteine ( tHcy ) during the last 3 weeks of the study . Consumption of 800 microg DFE/day result ed in serum folate concentrations that were 67 % ( P=.005 ) higher than consumption of 400 microg DFE/day ( 18.6+/-2.9 vs. 31.0+/-2.7 nmol/L , respectively ) and RBC folate concentrations that were 33 % ( P=.001 ) higher ( 1172+/-75 vs. 1559+/-70 nmol/L , respectively ) . Serum folate ( P=.065 ) and RBC folate ( P=.022 ) concentrations were lower and plasma tHcy was higher ( P=.039 ) in women with the MTHFR 677 TT genotype relative to the CC genotype . However , no genotype by dietary treatment interaction was detected . These data suggest that a doubling of food folate intake will lead to marked improvements in folate status in women with the MTHFR 677 CC or TT genotype Objective To determine an optimal population red blood cell ( RBC ) folate concentration for the prevention of neural tube birth defects . Design Bayesian model . Setting Data from two population based studies in China . Participants 247 831 participants in a prospect i ve community intervention project in China ( 1993 - 95 ) to prevent neural tube defects with 400 μg/day folic acid supplementation and 1194 participants in a population based r and omized trial ( 2003 - 05 ) to evaluate the effect of folic acid supplementation on blood folate concentration among Chinese women of reproductive age . Intervention Folic acid supplementation ( 400 μg/day ) . Main outcome measures Estimated RBC folate concentration at time of neural tube closure ( day 28 of gestation ) and risk of neural tube defects . Results Risk of neural tube defects was high at the lowest estimated RBC folate concentrations ( for example , 25.4 ( 95 % uncertainty interval 20.8 to 31.2 ) neural tube defects per 10 000 births at 500 nmol/L ) and decreased as estimated RBC folate concentration increased . Risk of neural tube defects was substantially attenuated at estimated RBC folate concentrations above about 1000 nmol/L ( for example , 6 neural tube defects per 10 000 births at 1180 ( 1050 to 1340 ) nmol/L ) . The modeled dose-response relation was consistent with the existing literature . In addition , neural tube defect risk estimates developed using the proposed model and population level RBC information were consistent with the prevalence of neural tube defects in the US population before and after food fortification with folic acid . Conclusions A threshold for “ optimal ” population RBC folate concentration for the prevention of neural tube defects could be defined ( for example , approximately 1000 nmol/L ) . Population based RBC folate concentrations , as a biomarker for risk of neural tube defects , can be used to facilitate evaluation of prevention programs as well as to identify sub population s at elevated risk for a neural tube defect affected pregnancy due to folate insufficiency INTRODUCTION Methylenetetrahydrofolate reductase ( MTHFR ) C677 T is involved in folate and homocysteine metabolism . Disruption in the activity of this enzyme will alter their levels in the body . METHODOLOGY This study assessed MTHFR C677 T polymorphism and its relationship with serum homocysteine and B-vitamins levels in a sample of Chinese and Malays subjects in UPM , Serdang . One hundred subjects were r and omly selected from among the university population . Folate , vitamin B12 , B6 , and homocysteine levels were determined using MBA , ECLIA , and HPLC , respectively . PCR coupled with HinfI digestion was used for detection of MTHFR C677 T polymorphism . RESULTS The frequency of T allele was higher in the Chinese subjects ( 0.40 ) compared to the Malay ( 0.14 ) . Folate , vitamin B12 and B6 levels were highest in the wild genotype in both ethnic groups . Subjects with heterozygous and homozygous genotype showed the highest homocysteine levels . The serum folate and homocysteine were mainly affected by homozygous genotype . CONCLUSION MTHFR C677 T polymorphism plays an important role in influencing the folate and homocysteine metabolism BACKGROUND The association between blood homocysteine concentration and the risk of cardiovascular disease ( CVD ) remains controversial , but few studies have examined the association between MTHFR C677 T ( a proxy for high homocysteine concentration ) and death from CVD . OBJECTIVE The objective was to examine associations of MTHFR C677 T , a proxy for high homocysteine concentrations , with CVD mortality and with all-cause mortality in a national representative prospect i ve cohort of the US adult population before the introduction of m and atory folic acid fortification of flour . DESIGN We used Mendelian r and omization to examine the association of MTHFR C677 T with cause-specific mortality in 5925 participants by accessing the NHANES III ( 1991 - 1994 ) Linked Mortality File ( through 2006 ) . RESULTS A comparison of homozygotes at baseline showed that individuals with a TT genotype had a 2.2-μmol/L higher homocysteine and a 1.4-ng/mL lower folate concentration , respectively , than did those with a CC genotype . The TT genotype frequency varied from 1.2 % ( 95 % CI : 0.7 , 2.0 ) in non-Hispanic blacks and 11.6 % ( 95 % CI : 9.6 , 14.0 ) in non-Hispanic whites to 19.4 % ( 95 % CI : 16.7 , 22.3 ) in Mexican Americans . After adjustment for ethnic group and other CVD risk factors , the MTHFR C677 T TT genotype was associated with significantly lower CVD mortality ( HR : 0.69 ; 95 % CI : 0.50 , 0 . 95 ) but had no significant effect on all-cause mortality ( HR : 0.79 ; 95 % CI : 0.59 , 1.05 ) . After stratification by period of follow-up , the inverse association of MTHFR with CVD mortality was significant only in the period after introduction of m and atory folic acid fortification . CONCLUSION The inverse association of MTHFR with CVD mortality was unexpected and highlights the need for caution in interpretation of Mendelian r and omization studies , which , like other observational studies , can be influenced by chance , bias , or confounding BACKGROUND The methylenetetrahydrofolate reductase ( MTHFR ) genotype is associated with modification of disease and risk of neural tube defects . Plasma and red blood cell ( RBC ) folate and plasma homocysteine concentrations change in response to daily intakes of folic acid supplements , but no large-scale or population -based r and omized trials have examined whether the MTHFR genotype modifies the observed response . OBJECTIVE We sought to determine whether the MTHFR 677C→T genotype modifies the response to folic acid supplementation during and 3 mo after discontinuation of supplementation . DESIGN Northern Chinese women of childbearing age were enrolled in a 6-mo supplementation trial of different folic acid doses : 100 , 400 , and 4000 μg/d and 4000 μg/wk . Plasma and RBC folate and plasma homocysteine concentrations were measured at baseline ; after 1 , 3 , and 6 mo of supplementation ; and 3 mo after discontinuation of supplementation . MTHFR genotyping was performed to identify a C→T mutation at position 677 ( n = 932 ) . RESULTS Plasma and RBC folate and homocysteine concentrations were associated with MTHFR genotype throughout the supplementation trial , regardless of folic acid dose . MTHFR TT was associated with lower folate concentrations , and the trend of TT < CC was maintained at even the highest doses . Folic acid doses of 100 μg/d or 4000 μg/wk did not reduce high homocysteine concentrations in those with the MTHFR TT genotype . CONCLUSION MTHFR genotype was an independent predictor of plasma and RBC folate and plasma homocysteine concentrations and did not have a significant interaction with folic acid dose during supplementation . This trial was registered at clinical trials.gov as NCT00207558
Output:
| Meta- analysis results ( limited to the MA , the recommended population assessment method ) indicated a consistent percentage difference in S/P and RBC folate concentrations across MTHFR C677 T genotypes .
Lower blood folate concentrations associated with this polymorphism could have implication s for a population -level risk of neural tube defects |
MS210982 | ***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 objective of this r and omized controlled trial was to assess the effects of a 1‐year behavioral contract intervention on immunosuppressant therapy ( IST ) adherence and healthcare utilizations and costs among adult renal transplant recipients ( RTRs ) . The sample included adult RTRs who were at least 1 year posttransplant , taking tacrolimus or cyclosporine and served by a specialty pharmacy . Pharmacy refill records were used to measure adherence and monthly question naires were used to measure healthcare utilizations . Direct medical costs were estimated using the 2009 Medicare Expenditure Panel Survey . Adherence was analyzed using the GLM procedure and the MIXED procedure of SAS . Rate ratios and 95 % confidence intervals were estimated to quantify the rate of utilizing healthcare services relative to treatment assignment . One hundred fifty RTRs were enrolled in the study . Intervention group RTRs ( n = 76 ) had higher adherence than control group RTRs ( n = 74 ) over the study period ( p < 0.01 ) . And 76.1 % of the intervention group compared with 42.7 % of the control group was not hospitalized during the 1‐year study period ( RR = 1.785 ; 95 % CI : 1.314 , 2.425 ) , result ing in cost savings . Thus , evidence supports using behavioral contracts as an effective adherence intervention that may improve healthcare outcomes and lower costs Russell C , Conn V , Ashbaugh C , Madsen R , Wakefield M , Webb A , Coffey D , Peace L. Taking immunosuppressive medications effectively ( TIMELink ) : a pilot r and omized controlled trial in adult kidney transplant recipients . Clin Transplant 2011 : 25 : 864–870 . © 2010 John Wiley & Sons 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 Scientific background Poor compliance or adherence in drug therapy can cause increased morbidity , mortality and enormous costs in the healthcare system ( in Germany annually approximately 10 billion euros ) . Different methods are used for enhancing the compliance or adherence . Research questions The evaluation addresses the questions about existence , efficacy , cost-benefit relation as well as ethical-social and juridical implication s of strategies for enhancing compliance or adherence in drug therapy with concomitant improvements in treatment outcomes . Methods A systematic literature search was conducted in the medical , also health economic relevant , literature data bases in January 2007 , beginning from 2002 . Systematic review s on the basis of ( r and omised controlled trials ( RCT ) concerning interventions to enhance compliance or adherence with regard to treatment outcomes as well as systematic review s of health economic analyses were included in the evaluation . Additionally , it was also search ed for publications which primarily considered ethical-social and juridical aspects of these interventions for the German context . Results One systematic review with data for 57 RCT was included in the medical evaluation and one systematic review with data for six studies into the health economic evaluation . No publication primary concerning ethical-social or juridical implication s could be identified . A significant positive effect on the treatment outcome was reported for 22 evaluated interventions . For many interventions the results can be classified as reliable : counseling with providing an information leaflet and compliance diary chart followed by phone consultation for helicobacter pylori positive patients , repeated counseling for patients with acute asthma symptoms , telephone calls to establish the level of compliance and to make recommendations based on that for the therapy of cardiovascular diseases , calls of an automated telephone system with phone counseling in problem cases for diabetics , different family based interventions including repeated family counseling , education and " culturally modified family therapy " in patients with schizophrenia , repeated " compliance therapy " sessions for patients with acute psychosis . For other interventions the results should be viewed with more concern ( because of the poor method ical quality of the underlying studies ) . The effect size of the interventions can not be estimated from the available data . From the available data , no reliable results can be provided concerning the cost-benefit relation of these strategies . Discussion Many of the reported studies had a poor reporting and method ological quality . The reliability of the conclusions of the studies is restricted because of method ical shortcomings . Efficacy and cost estimates determined in the health economic studies are not transferable to the current situation in Germany . It has been discussed recently that the compliance or adherence enhancing interventions can restrict the autonomy and the privacy of the patients . Conclusions In drug therapy some compliance or adherence enhancing interventions with concomitant positive effect on the treatment outcome may be used . The cost-benefit relation of these interventions is to be estimated . Using these interventions the patient ’s autonomy and privacy are to be restricted as few as possible Background Unintentional non-adherence has been characterized as passively inconsistent medication-taking behavior ( forgetfulness or carelessness ) . Our objectives were to : ( 1 ) study the prevalence and predictors of unintentional non-adherence ; and ( 2 ) explore the interrelationship between intentional and unintentional non-adherence in relation to patients ’ medication beliefs . Methods We conducted a cross-sectional survey of adults with asthma , hypertension , diabetes , hyperlipidemia , osteoporosis , or depression from the Harris Interactive Chronic Illness Panel . The analytic sample for this study included 24,017 adults who self-identified themselves as persistent to prescription medications for their index disease . They answered three questions on unintentional non-adherence ( forgot , ran out , being careless ) , 11 questions on intentional non-adherence , and three multi-item scales assessing perceived need for medication ( k = 10 ) , perceived medication concerns ( k = 6 ) , and perceived medication affordability ( k = 4 ) . Logistic regression was used to model predictors of each unintentional non-adherence behavior . Baron and Kenny ’s regression approach was used to test the mediational effect of unintentional non-adherence on the relationship between medication beliefs and intentional non-adherence . Bootstrapping was employed to confirm the statistical significance of these results . Results For the index disease , 62 % forgot to take a medication , 37 % had run out of the medication , and 23 % were careless about taking the medication . Common multivariate predictors ( p < .001 ) of the three behaviors were : ( 1 ) lower perceived need for medications ; ( 2 ) more medication affordability problems ; ( 3 ) worse self-rated health ; ( 4 ) diabetes or osteoporosis ( relative to hypertension ) ; and ( 5 ) younger age . Unique statistically-significant predictors of the three behaviors were : ( a ) ‘ forgot to take medications ’ - greater concerns about the index medication and male gender ; ( b ) ‘ run out of medications ’ - non-white race , asthma , and higher number of total prescription medications ; ( c ) ‘ being careless ’ - greater medication concerns . Mediational tests confirmed the hypothesis that the effect of medication beliefs ( perceived need , concerns , and affordability ) on intentional non-adherence is mediated through unintentional non-adherence . Conclusions For our study sample , unintentional non-adherence does not appear to be r and om and is predicted by medication beliefs , chronic disease , and sociodemographics . The data suggests that the importance of unintentional non-adherence may lie in its potential prognostic significance for future intentional non-adherence . Health care providers may consider routinely inquiring about unintentional non-adherence in order to proactively address patients ’ suboptimal medication beliefs before they choose to discontinue therapy all together Background Outcome after renal transplantation depends on patient compliance and adherence for early detection of complications and identification of intervention opportunities . Compliance describes the degree to which patients follow medical advice and take their medications . Adherence has been defined as the extent to which a patients ' behavior coincides with clinical prescriptions . Material s and Methods Patients were r and omized 7 to 14 days after transplantation into groups with ( n = 40 ) and without ( n = 40 ) an electronic medication dispenser ( EMD ) . The EMD , which was used for the 1-year study period , recorded the date and time the patient took their medications and was monitored via a web-based application . Patients were monitored for 1 year regarding outpatient follow-up visits , emergency hospitalizations , renal biopsies , rejection episodes , renal function , and blood concentration of medications . Results Compliance in the intervention group was 97.8 % ( the control group was not assessed ) . Number of missed doses varied significantly by weekday ( P = 0.033 ) ; patients were most likely to miss doses on Saturdays and Thursdays . Patients missed a total of 11 follow-up visits . During the study , 92 biopsies were performed on 55 patients ( intervention group : 32 [ 17 ] ; control group , 60 [ 38 ] ) . Biopsy-verified rejection was three times more common among controls ( 13 patients vs 4 ; P = 0.054 , not significant ) . Average P-creatinine level was slightly lower in the intervention group than the control group ( 131 vs 150 & mgr;mol/L , not significant ) , whereas mean tacrolimus was similar ( 7.32 vs 7.22 ng/mL , n.s . ) . Conclusions The EMD is associated with high compliance , and there are also indications of a lower rejection rate Background : Non‐compliance with immunosuppressive medications may result in allograft rejection and is regarded as an important impediment to post‐transplant care . This r and omized , controlled trial evaluates the impact of clinical pharmacy services on renal transplant patients ’ compliance with immunosuppressive agents . Methods : Patients who received a renal transplant at the Medical College of Georgia from February 1997 through January 1999 were r and omized in the intervention or control group provided they met study criteria . In addition to routine clinic services at each clinic visit , patients in the intervention group received clinical pharmacy services , which included medication histories and review of patients ’ medications with an emphasis on optimizing medication therapy to achieve desired outcomes and minimizing adverse medication events . The clinical pharmacist also provided recommendations to the nephrologists with the goal of achieving desired outcomes . To promote medication compliance by using compliance enhancement strategies , the clinical pharmacist counseled patients concerning their medication therapy and instructed them how to properly take their medications . Patients in the control group received the same routine clinic services as the intervention group except that they did not have any clinical pharmacist interaction . Compliance rate ( CR ) was calculated and patient 's compliance status was determined from the CR . The CR , the fraction of patients remaining compliant for each month , and the mean time patients were compliant were compared between groups . Whether there was a difference in the frequency of patients achieving ‘ target ’ immunosuppressive levels in the control and study groups was evaluated . Results : The mean CR for patients who had clinical pharmacist intervention ( n=12 ) was statistically higher than the control group 's ( n=12 ) mean CR ( p<0.001 ) . During the 12‐month post‐transplant study period , patients in the intervention group had a longer duration of compliance than patients in the control group ( p<0.05 ) . Additionally , patients who had clinical pharmacy services had a greater achievement of ‘ target ’ levels than patients who did not receive these services ( p<0.05 ) . Conclusions : Patients who received clinical pharmacy services with traditional patient care services had better compliance with immunosuppressants than patients who only received traditional patient care services . Results of this study suggest a multidisciplinary team that includes a clinical pharmacist as part of the care for post‐transplant patients is beneficial for enhancing medication compliance Abstract : Background : Although non‐adherence to an immunosuppressive regimen ( NAH ) is a major risk factor for poor outcome after renal transplantation ( RTx ) , very few studies have examined non‐adherence intervention in this context . This pilot r and omized controlled trial ( RCT ) tested the efficacy of an educational – behavioural intervention to increase adherence in non‐adherent RTx patients . We also assessed how NAH evolves over time OBJECTIVES Improving treatment adherence to immunosuppressive agents could have positive effects on the morbidity and mortality of kidney transplant recipients . Our objective was to determine whether psychoeducational intervention aim ed at improving treatment adherence also could improve 10-year kidney allograft survival rates . MATERIAL S AND METHODS A r and omized open-label study compared a group who received psychoeducational intervention ( n = 55 ) with a control group ( n = 55 ) , with all patients being kidney transplant recipients in the Department of Nephrology and Organ Transplantation ( University Hospital , Toulouse , France ) . Psychoeducational intervention comprised 8 weekly sessions provided by multidisciplinary teams . Patients were included between 2002 and 2003 . The primary endpoint was allograft survival at 10 years ( ie , by 2012 ) . A failed allograft or death with a functioning allograft was considered an event . RESULTS Mean overall allograft survival rate at 10 years was 78.2 % ( 95 % confidence interval , 70.5 - 25.3 ) . In the control group , 48 patients ( 43.6 % ) still had a functioning graft at 10 years versus 38 patients ( 34.5 % ) in the psychoeducational inter
Output:
| Intervention effect was only moderate .
Most adherence measures in studies on educational and behavioral interventions showed statistically significant differences .
Studies that combined educational and behavioral intervention components showed larger effects .
Studies that included an individualized component and more intensive interventions showed larger effects .
Conclusion Educational and behavioral AEI can increase adherence .
In particular , multimodal and individualized interventions seem promising .
However , because of the small effect , the high risk of bias , and the invalidity of adherence measures , the actual benefit of adherence interventions for an unselected patient population ( i.e. , including also adherent patients ) seems limited .
No conclusion is possible for interventions combining adherence-enhancing components that address intentional ( behavioral ) as well as unintentional adherence ( reminder ) |
MS210983 | ***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 This r and omised study compared protracted venous infusion ( PVI ) fluorouracil ( 5-FU ) with PVI 5-FU plus mitomycin C ( MMC ) in patients with advanced oesophago-gastric cancer . PATIENTS AND METHODS Two hundred and fifty-four patients with adenocarcinoma , squamous cell carcinoma or undifferentiated carcinoma involving the oesophagus , oesophago-gastric junction or the stomach were r and omised . The major end points were tumour response , survival , toxicity and quality of life . RESULTS The median age of patients treated was 72 years and the two arms were well-balanced for baseline demographic factors . The overall response rate was 16.1 % [ 95 % confidence interval ( CI ) 9.5 % to 22.7 % ] in patients treated with PVI 5-FU alone compared with 19.1 % ( 95 % CI 12.0 % to 26.0 % ) for those treated with PVI 5-FU plus MMC ( P = 0.555 ) . Median time to treatment failure was 3.9 months for PVI 5-FU and 3.8 months for PVI 5-FU plus MMC ( P = 0.195 ) . Median survival was 6.3 months for PVI 5-FU and 5.3 months for PVI 5-FU plus MMC ( P = 1.0 ) . Toxicity was mild for both treatments . Symptomatic benefit measured by improvement in pain control , weight loss , dysphagia and oesophageal reflux was observed in over 64 % of patients in each arm . Quality of life scores were comparable in each arm . CONCLUSIONS PVI 5-FU is a safe , effective form of palliation for patients with advanced oesophago-gastric cancer although the addition of MMC adds little extra benefit BACKGROUND We aim ed to establish the superiority ( or noninferiority if superiority was not achieved ) in terms of time to progression ( TTP ) of irinotecan/5-fluorouracil ( IF ) over cisplatin/5-fluorouracil ( CF ) in chemonaive patients with adenocarcinoma of the stomach/esophagogastric junction . PATIENTS AND METHODS Patients received either IF : i.v . irinotecan 80 mg/m(2 ) 30 min , folinic acid 500 mg/m(2 ) 2 h , 5-fluorouracil ( 5-FU ) 2000 mg/m(2 ) 22 h , for 6/7 weeks or CF : cisplatin 100 mg/m(2 ) 1 - 3 h , with 5-FU 1000 mg/m(2)/day 24 h , days 1 - 5 , every 4 weeks . RESULTS In all , 333 patients were r and omized and treated ( IF 170 , CF 163 ) . Patient characteristics were balanced except more IF patients had Karnofsky performance status 100 % . TTP for IF was 5.0 months [ 95 % confidence interval ( CI ) 3.8 - 5.8 ] and 4.2 months ( 95 % CI 3.7 - 5.5 ) for CF ( P = 0.088 ) . Overall survival ( OS ) was 9.0 versus 8.7 months , response rate 31.8 % versus 25.8 % , time to treatment failure ( TTF ) 4.0 versus 3.4 months for IF and CF , respectively . The difference in TTF was statistically significant ( P = 0.018 ) . IF was better in terms of toxic deaths ( 0.6 % versus 3 % ) , discontinuation for toxicity ( 10.0 % versus 21.5 % ) , severe neutropenia , thrombocytopenia and stomatitis , but not diarrhea . CONCLUSION IF did not yield a significant TTP or OS superiority over CF , and the results of noninferiority of IF were borderline . However , IF may provide a viable , platinum-free front-line treatment alternative for metastatic gastric cancer BACKGROUND Clinical data showed promising antitumour activity with feasible tolerability for matuzumab plus epirubicin , cisplatin and capecitabine ( ECX ) chemotherapy in untreated advanced oesophago-gastric ( OG ) cancer . The aim was to evaluate the efficacy of matuzumab plus ECX versus ECX alone . PATIENTS AND METHODS In this multicentre , r and omised open-label phase II study , 72 patients with metastatic OG cancer were r and omly assigned to either 800 mg matuzumab weekly plus epirubicin 50 mg/m² , cisplatin 60 mg/m² on day 1 and capecitabine 1250 mg/m² daily in a 21-day cycle ( ECX ) or the same ECX regimen alone . The primary end point was objective response . Secondary end points included progression-free survival ( PFS ) , overall survival ( OS ) , quality of life , safety and tolerability . RESULTS Following r and om assignment , 35 patients ( median age 59 years ) received ECX/matuzumab and 36 patients ( median age 64 years ) ECX . The addition of matuzumab to ECX did not improve objective response : 31 % for ECX/matuzumab [ 95 % confidence interval ( CI ) 17 - 49 ] compared with 58 % for the ECX arm ( 95 % CI 41 - 74 ) P = 0.994 ( one sided ) . There was no significant difference in median PFS : 4.8 months ( 95 % CI 2.9 - 8.1 ) for ECX/matuzumab versus 7.1 months ( 95 % CI 4.4 - 8.5 ) for ECX , or in median OS : 9.4 months ( 95 % CI 7.5 - 16.2 ) , compared with 12.2 months ( 95 % CI 9.8 - 13.8 months ) . Grade 3/4 treatment-related toxicity was observed in 27 and 25 patients in the ECX/matuzumab and ECX groups , respectively . CONCLUSION Matuzumab 800 mg weekly combined with ECX chemotherapy does not increase response or survival for patients with advanced OG cancer . Therefore , ECX/matuzumab should not be examined further in phase III trials 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 purpose of the study was to establish the optimal dose of capecitabine ( X ) to be used within a multicentre , r and omised study evaluating the potential roles of oxaliplatin ( O ) and X in chemonaive patients ( pts ) with advanced oesophagogastric cancer . Two by two design was used , and pts were r and omised to one of four regimens and stratified for extent of disease , performance status ( PS ) and centre . The treatment regimens are epirubicin , cisplatin , 5-fluorouracil ( ECF ) , EOF , ECX or EOX . Doses : E 50 mg m−2 , C 60 mg m−2 and O 130 mg m−2 i.v . 3 weekly ; F 200 mg m−2 day−1 i.v . and X 500 mg m−2 b.i.d.−1 ( escalated to 625 mg m−2 b.i.d.−1 after results of first interim analysis ) p.o . , continuously . First interim analysis was performed when 80 pts had been r and omised . Dose-limiting fluoropyrimidine toxicities were stomatitis , palmar plantar erythema ( PPE ) and diarrhoea ; 5.1 % of X-treated pts experienced grade 3/4 toxicity . Protocol planned dose escalation of X to 625 mg m−2 b.i.d.−1 was instituted and a second interim analysis has been performed ; results are presented in this paper . A total of 204 pts were r and omised at the time of the protocol planned 2nd interim analysis . Grade 3/4 fluoropyrimidine-related toxicity was seen in 13.7 % pts receiving F , 8.4 % pts receiving X 500 mg m−2 b.i.d.−1 and 14.7 % pts receiving X 625 mg m−2 b.i.d.−1 . Combined complete and partial response rates were ECF 31 % ( 95 % CI 18.7–46.3 ) , EOF 39 % ( 95 % CI 25.9–53.1 ) , ECX 35 % ( 95 % CI 21.4–50.3 ) , EOX 48 % ( 95 % CI 33.3–62.8 ) . Grade 3/4 fluoropyrimidine toxicity affected 14.7 % of pts treated with X 625 mg m−2 b.i.d.−1 , which is similar to that observed with F , confirming this to be the optimal dose . The replacement of C by O and F by X does not appear to impair efficacy . The trial continues to total accrual of 1000 pts OBJECTIVES : A dramatic rise in incidence , an aging population , and expensive palliative treatments have led to an escalating burden on clinicians managing inoperable esophageal cancer with only limited evidence of effectiveness . This study compares the clinical effectiveness and cost-effectiveness of self-exp and ing metal stents ( SEMSs ) with other palliative therapies to aid clinicians in making an evidence -based treatment choice . METHODS : We conducted a prospect i ve , multicenter , r and omized , controlled , clinical trial with 215 patients followed until death or study closure . The primary outcome measures were dysphagia , quality of life ( QL ) 6 weeks following treatment , and total cost of treatment . Secondary outcome measures included treatment-associated morbidity , mortality , survival , and cost-effectiveness . An intention-to-treat analysis was carried out . RESULTS : There was a significant difference in mean dysphagia grade between treatment arms 6 weeks following treatment ( P=0.046 ) , with worse swallowing reported by rigid stent – treated patients ( mean dysphagia score difference=−0.49 ; 95 % confidence interval ( CI ) −0.10 to −0.89 , P=0.014 ) . Global QL scores were lower at both 1 and 6 weeks following treatment for patients treated by SEMSs ( mean difference QL index week 1=−0.66 ; 95 % CI : −0.02 to −1.30 , P=0.04 ; mean difference QL index week 6=−1.01 ; 95 % CI −0.30 to −1.72 , P=0.006 ) . These findings were associated with higher post-procedure pain scores in the SEMS patient group ( mean difference of the European Organisation for Research and Treatment of Cancer QLQ C-30 pain symptom score at week 1=11.13 ; 95 % CI : 2.89–19.4 ; P=0.01 ) . Although mean EQ-5D QL values differed between the treatments ( P<0.001 ) , this difference dissipated following generation of quality -adjusted life year values . Total costs varied between treatment arms but these findings canceled out when SEMSs were compared with non-SEMS therapies ( 95 % CI −845.15–1,332.62 ) . These results were robust to sensitivity analysis . There were no differences in the in-hospital mortality or early complication rates , but late complications were more frequent after rigid stenting ( risk ratio=2.47 ; 95 % CI 1.88–3.04 ) . There was a survival advantage for non-stent-treated patients ( log-rank statistic=4.21 , P=0.04 ) . CONCLUSIONS : The treatment choice for patients with inoperable esophageal cancer should be between a SEMS or a non-stent treatment after consideration has been given to both patient and tumor characteristics and clinician and patient preferences PURPOSE Between 1994 and 1997 , 22 patients with dysphagia from advanced incurable esophageal cancer were enrolled in a phase I/II prospect i ve study to assess the palliative benefit and toxicity of a short course of radiotherapy with chemotherapy . METHODS The study population included 17 men and five women with a median age of 69 ( range 43 - 84 ) . Patients were treated with 30 Gy in ten fractions to the mediastinum with a concurrent single course of chemotherapy ( 5-FU , 1000 mg/m(2 ) , days 1 - 4 and mitomycin-C 10 mg/m(2 ) , day 1 ) . Swallowing ability was recorded each day on a self-administered diary card using the five point dysphagia index of the MRC ( UK ) . The median baseline MRC swallowing score was 4 ( can not swallow solids ) . RESULTS Treatment was generally well tolerated , but seven ( 32 % ) patients had transient worsening of dysphagia scores immediately following treatment because of esophagitis ; fifteen ( 68 % ) achieved a complete response ( score
Output:
| All phase II chemotherapy studies reported maintained HRQL or improved dysphagia combined with low level of toxicity . |
MS210984 | ***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 . Birth asphyxia represents a serious problem worldwide , result ing in ∼1 million deaths and an equal number of serious sequelae annually . It is therefore important to develop new and better ways to treat asphyxia . Resuscitation after birth asphyxia traditionally has been carried out with 100 % oxygen , and most guidelines and textbooks recommend this ; however , the scientific background for this has never been established . On the contrary , theoretic considerations indicate that resuscitation with high oxygen concentrations could have detrimental effects . We have performed a series of animal studies as well as one pilot study indicating that resuscitation can be performed with room air just as efficiently as with 100 % oxygen . To test this more thoroughly , we organized a multicenter study and hypothesized that room air is superior to 100 % oxygen when asphyxiated newborn infants are resuscitated . Methodology . In a prospect i ve , international , controlled multicenter study including 11 centers from six countries , asphyxiated newborn infants with birth weight > 999 g were allocated to resuscitation with either room air or 100 % oxygen . The study was not blinded , and the patients were allocated to one of the two treatment groups according to date of birth . Those born on even date s were resuscitated with room air and those born on odd date s with 100 % oxygen . Informed consent was not obtained until after the initial resuscitation , an arrangement in agreement with the new proposal of the US Food and Drug Administration 's rules governing investigational drugs and medical devices to permit clinical research on emergency care without the consent of subjects . The protocol was approved by the ethical committees at each participating center . Entry criterion was apnea or gasping with heart rate < 80 beats per minute at birth necessitating resuscitation . Exclusion criteria were birth weight < 1000 g , lethal anomalies , hydrops , cyanotic congenital heart defects , and stillbirths . Primary outcome measures were death within 1 week and /or presence of hypoxic – ischemic encephalopathy , grade II or III , according to a modification of Sarnat and Sarnat . Secondary outcome measures were Apgar score at 5 minutes , heart rate at 90 seconds , time to first breath , time to first cry , duration of resuscitation , arterial blood gases and acid base status at 10 and 30 minutes of age , and abnormal neurologic examination at 4 weeks . The existing routines for resuscitation in each participating unit were followed , and the ventilation techniques described by the American Heart Association were used as guidelines aim ing at a frequency of manual ventilation of 40 to 60 breaths per minute . Results . Forms for 703 enrolled infants from 11 centers were received by the steering committee . All 94 patients from one of the centers were excluded because of violation of the inclusion criteria in 86 of these . Therefore , the final number of infants enrolled in the study was 609 ( from 10 centers ) , with 288 in the room air group and 321 in the oxygen group . Median ( 5 to 95 percentile ) gestational ages were 38 ( 32.0 to 42.0 ) and 38 ( 31.1 to 41.5 ) weeks ( NS ) , and birth weights were 2600 ( 1320 to 4078 ) g and 2560 ( 1303 to 3900 ) g ( NS ) in the room air and oxygen groups , respectively . There were 46 % girls in the room air and 41 % in the oxygen group ( NS ) . Mortality in the first 7 days of life was 12.2 % and 15.0 % in the room air and oxygen groups , respectively ; adjusted odds ratio ( OR ) = 0.82 with 95 % confidence intervals ( CI ) = 0.50–1.35 . Neonatal mortality was 13.9 % and 19.0 % ; adjusted OR = 0.72 with 95 % CI = 0.45–1.15 . Death within 7 days of life and /or moderate or severe hypoxic – ischemic encephalopathy ( primary outcome measure ) was seen in 21.2 % in the room air group and in 23.7 % in the oxygen group ; OR = 0.94 with 95 % CI = 0.63–1.40 . Heart rates did not differ between the two groups at any time point and were ( mean ± SD ) 90 ± 31 versus 93 ± 33 beats per minute at 1 minute and 110 ± 27 versus 113 ± 30 beats per minute at 90 seconds in the room air and oxygen groups , respectively . Apgar scores at 1 minute ( median and 5 to 95 percentiles ) were significantly higher in the room air group ( 5 [ 1 to 6.7 ] ) than in the oxygen group ( 4 [ 1 to 7 ] ) ; however , at 5 minutes there were no significant differences , with 8 ( 4 to 9 ) versus 7 ( 3 to 9 ) . There were significantly more infants with very low 1-minute Apgar scores ( < 4 ) in the oxygen group ( 44.4 % ) than in the room air group ( 32.3 % ) . There also were significantly more infants with 5-minute Apgar score < 7 in the oxygen group ( 31.8 % ) than in the room air group ( 24.8 % ) . There were no differences in acid base status or Sao 2during the observation period between the two groups . Mean ( SD ) Pao 2 was 31 ( 17 ) versus 30 ( 22 ) mm Hg in cord blood in the room air and oxygen groups , respectively ( NS ) . At 10 minutes Pao 2 was 76 ( 32 ) versus 87 ( 49 ) mm Hg ( NS ) , and at 30 minutes , the values were 74 ( 29 ) versus 89 ( 42 ) mm Hg in the room air and oxygen groups , respectively . Median ( 95 % CI ) time to first breath was 1.1 ( 1.0–1.2 ) minutes in the room air group versus 1.5 ( 1.4 to 1.6 ) minutes in the oxygen group . Time to the first cry also was in mean 0.4 minute shorter in the room air group compared with the oxygen group . In the room air group , there were 25.7 % so-called resuscitation failures ( bradycardia and /or central cyanosis after 90 seconds ) that were switched to 100 % oxygen after 90 seconds . The percentage of resuscitation failures in the oxygen group was 29.8 % . Conclusions . This study with patients enrolled primarily from developing countries indicates that asphyxiated newborn infants can be resuscitated with room air as efficiently as with pure oxygen . In fact , time to first breath and first cry was significantly shorter in room air- versus oxygen-resuscitated infants . Resuscitation with 100 % oxygen may depress ventilation and therefore delay the first breath . More studies are needed confirming these results before resuscitation guidelines are changed ABSTRACT : To test the hypothesis that room air is superior to 100 % oxygen when asphyxiated newborns are resuscitated , 84 neonates ( birth weight > 999 g ) with heart rate < 80 and /or apnea at birth were allocated to be resuscitated with either room air ( n = 42 ) or 100 % oxygen ( n = 42 ) . Serial , unblinded observations of heart rates at 1 , 3 , 5 , and 10 min and Apgar scores at 1 min revealed no significant differences between the two groups . At 5 min , median ( 25th and 75th percentile ) Apgar scores were higher in the room air than in the oxygen group [ 8 ( 7–9 ) versus 7 ( 6–8 ) , p = 0.03 ] . After the initial resuscitation , arterial partial pressure of oxygen , pH , and base excess were comparable in the two groups . Assisted ventilation was necessary for 2.4 ( 1.5–3.4 ) min in the room air group and 3.0 ( 2.0–4.0 ) min in the oxygen group ( p = 0.14 ) . The median time to first breath was 1.5 ( 1.0–2.0 ) min in both the room air and oxygen groups ( p = 0.59 ) , and the time to first cry was 3.0 ( 2.0–4.0 ) min and 3.5 ( 2.5–5.5 ) min in the room air and oxygen groups , respectively ( p = 0.19 ) . Three neonates in the room air group and four in the oxygen group died in the neonatal period . At 28 d , 72 of the 77 surviving neonates were available for follow-up ( 36 in each group ) , and none had any neurologic sequelae . This preliminary study did not provide conclusive evidence that room air is superior to 100 % oxygen in the resuscitation of asphyxiated newborns , although it indicated that room air is as effective as 100 % oxygen . Additional trials with increased numbers of patients are necessary before deciding whether room air or oxygen should be used in clinical practice OBJECTIVE To follow-up children who had been resuscitated at birth with either 21 % or 100 % oxygen ( O2 ) . METHODS A multicenter study with 10 participating centers recruited 609 infants to the Resair 2 study where resuscitation was performed with either 21 % or 100 % O2 . A follow-up between ages 18 and 24 months was performed . However , during follow-up registration , it was found that 18 infants had been enrolled twice in the original Resair 2 study with different registration numbers , leaving 591 enrolled in the Resair 2 study and 410 enrolled in the 7 centers participating in the follow-up . Of these 410 infants , 79 died ( 76 in the neonatal and 3 in the postneonatal period ) . Furthermore , for 8 infants informed consent was not obtained , leaving 323 eligible for follow-up . Of these , 213 infants ( 66 % ) were followed-up : 91 ( 62 % ) had been resuscitated with 21 % O2 , and 122 ( 69 % ) with 100 % O2 . At a median age of 22 and 20 months ( not significant ) in the 21 % and 100 % groups , respectively , a simple question naire was filled out and neurologic assessment was performed in addition to measuring anthropometric data . RESULTS There were no significant differences in weight , height , or head circumference between the 2 groups . Cerebral palsy developed in 10 % and 7 % , respectively , in the 2 groups ( not significant ) . In total , 11 cases ( 12 % ) in the 21 % versus 11 cases ( 9 % ) in the 100 % O(2 ) group ( odds ratio : 1.39 , 95 % confidence interval : 0.57 - 3.36 ) developed cerebral palsy and /or mental or other delay . Furthermore , it was concluded that 14 ( 15 % ) in the 21 % group and 12 ( 10 % ) in the 100 % group were not normal ( odds ratio : 1.67 , 95 % confidence interval : 0.73 - 3.80 ) . CONCLUSIONS There were no significant differences in somatic growth or neurologic h and icap at an age of 18 to 24 months in infants resuscitated with either 21 % or 100 % O2 at birth . Based on these data , resuscitation with ambient air seems to be safe , at least in most cases . More studies are needed to settle this issue We describe a prospect i ve cross-sectional survey over a 12-month period in the principal maternity hospital of Kathm and u , Nepal , where over 50 % of the local population deliver . The study aim was to estimate the contribution of birth asphyxia to perinatal mortality in this setting . During 1995 , there were 14,371 livebirths and 400 stillbirths , a total stillbirth rate of 27 per 1000 total births . The fresh term ( 2000 g or more ) stillbirth rate was 8.5 per 1000 total births [ 95 % CI 7.1 , 10.1 ] . Ninety-two cases of neonatal encephalopathy ( NE ) affecting term infants were detected ( excluding those due to congenital malformations , hypoglycaemia and early neonatal sepsis ) . The birth prevalence of NE was 6.4 per 1000 livebirths [ 95 % CI 5.2 , 7.8 ] . There was evidence of intrapartum compromise in 63 ( 68 % ) of the cases of NE and 65 ( 76 % ) of the stillbirths , but only in 12 ( 12 % ) of controls . The cause-specific early neonatal mortality rate for NE was 2.1 per 1000 livebirths [ 95 % CI 1.4 , 3.0 ] . Combining the NE deaths and fresh stillbirths gives an upper estimate for term birth asphyxia perinatal mortality rate of 10.8 per 1000 total births [ 95 % CI 9.2 , 12.6 ] , 24 % of all perinatal deaths before hospital discharge . This study suggests that birth asphyxia remains an important cause of perinatal mortality in developing countries . The paper discusses the pros and cons of different strategies to reduce birth asphyxia in low-income countries Background . Traditionally , asphyxiated newborn infants have been
Output:
| Conclusions : A systematic review and meta- analysis demonstrated that neonatal mortality is significantly reduced when depressed newly born infants are resuscitated with ambient air instead of pure oxygen .
For infants with low 1-min Apgar score ( < 4 ) , no significant difference in neonatal mortality was found .
Recovery was faster in infants resuscitated with 21 % O2 than 100 % O2 |
MS210985 | ***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 Anthracycline ( ANT ) chemotherapy is associated with cardiotoxicity . Prevention with β-blockers remains controversial . OBJECTIVES This prospect i ve , r and omized , double-blind , placebo-controlled study sought to evaluate the role of carvedilol in preventing ANT cardiotoxicity . METHODS The authors r and omized 200 patients with HER2-negative breast cancer tumor status and normal left ventricular ejection fraction ( LVEF ) referred for ANT ( 240 mg/m2 ) to receive carvedilol or placebo until chemotherapy completion . The primary endpoint was prevention of a ≥10 % reduction in LVEF at 6 months . Secondary outcomes were effects of carvedilol on troponin I , B-type natriuretic peptide , and diastolic dysfunction . RESULTS Primary endpoint occurred in 14 patients ( 14.5 % ) in the carvedilol group and 13 patients ( 13.5 % ) in the placebo group ( p = 1.0 ) . No differences in changes of LVEF or B-type natriuretic peptide were noted between groups . A significant difference existed between groups in troponin I levels over time , with lower levels in the carvedilol group ( p = 0.003 ) . Additionally , a lower incidence of diastolic dysfunction was noted in the carvedilol group ( p = 0.039 ) . A nonsignificant trend toward a less-pronounced increase in LV end-diastolic diameter during the follow-up was noted in the carvedilol group ( 44.1 ± 3.64 mm to 45.2 ± 3.2 mm vs. 44.9 ± 3.6 mm to 46.4 ± 4.0 mm ; p = 0.057 ) . CONCLUSIONS In this largest clinical trial of β-blockers for prevention of cardiotoxicity under contemporary ANT dosage , the authors noted a 13.5 % to 14.5 % incidence of cardiotoxicity . In this scenario , carvedilol had no impact on the incidence of early onset of LVEF reduction . However , the use of carvedilol result ed in a significant reduction in troponin levels and diastolic dysfunction . ( Carvedilol Effect in Preventing Chemotherapy-Induced Cardiotoxicity [ CECCY ] ; NCT01724450 ) Purpose The primary toxicity of trastuzumab therapy for human epidermal growth factor receptor 2-overexpressing ( HER2-positive ) breast cancer is dose-independent cardiac dysfunction . Angiotensin-converting enzyme inhibitors and β-blockers are recommended first-line agents for heart failure . We hypothesized that angiotensin-converting enzyme inhibitors and β-blockers could prevent trastuzumab-related cardiotoxicity . Patients and Methods In this double-blinded , placebo-controlled trial , patients with HER2-positive early breast cancer were r and omly assigned to receive treatment with perindopril , bisoprolol , or placebo ( 1:1:1 ) for the duration of trastuzumab adjuvant therapy . Patients underwent cardiac magnetic resonance imaging at baseline and post-cycle 17 for the determination of left ventricular volumes and left ventricular ejection fraction ( LVEF ) . Cardiotoxicity was evaluated as the change in indexed left ventricular end diastolic volume and LVEF . Results Thirty-three patients received perindopril , 31 received bisoprolol , and 30 received placebo . Baseline demographic , cancer , and cardiovascular profiles were similar between groups . Study drugs were well tolerated with no serious adverse events . After 17 cycles of trastuzumab , indexed left ventricular end diastolic volume increased in patients treated with perindopril ( + 7 ± 14 mL/m2 ) , bisoprolol ( + 8 mL ± 9 mL/m2 ) , and placebo ( + 4 ± 11 mL/m2 ; P = .36 ) . In secondary analyses , trastuzumab-mediated decline in LVEF was attenuated in bisoprolol-treated patients ( -1 ± 5 % ) relative to the perindopril ( -3 ± 4 % ) and placebo ( -5 ± 5 % ) groups ( P = .001 ) . Perindopril and bisoprolol use were independent predictors of maintained LVEF on multivariable analysis . Conclusion Perindopril and bisoprolol were well tolerated in patients with HER2-positive early breast cancer who received trastuzumab and protected against cancer therapy-related declines in LVEF ; however , trastuzumab-mediated left ventricular remodeling-the primary outcome -was not prevented by these pharmacotherapies BACKGROUND The use of antracycline ( ANT ) in breast cancer has been associated with adverse cardiac events . Two-dimensional ( 2D ) strain imaging ( SI ) can provide a more sensitive measure of altered left ventricular ( LV ) systolic function . We aim ed to evaluate the preventive effect of carvedilol administration assessed by SI in a patient with breast cancer treated with ANT . METHODS Patients receiving ANT were r and omly assigned to the carvedilol- or placebo-receiving group . Each received an echocardiographic examination with conventional 2D echocardiography , pulsed tissue Doppler , and 2D SI prior to and 6 months post ANT treatment . RESULTS During the 6-month follow-up period there were no patient deaths or interrupted chemotherapy treatments due to doxorubicin-induced cardiotoxicity . Both left ventricular ejection fraction ( LVEF ) and fractional shortening ( FS ) were within normal limits for all patients before and after ANT therapy . EF , FS and LV dimensions were measured using M-mode echocardiography and found to be similar in both groups before and after ANT therapy . The mean EF , FS , and LV echocardiograph baseline and control dimensions were similar in both groups after 6 months . Though baseline SI parameters were similar between the groups , there was a significant decrease in LV basal septal and basal lateral peak systolic strain in the control group compared to the carvedilol group . CONCLUSIONS These results indicate that carvedilol has a protective effect against the cardiotoxicity induced by ANT 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 Purpose : Anthracyclines ( ANTs ) are a class of active antineoplastic agents with topoisomerase-interacting activity that are considered the most active agents for the treatment of breast cancer . We investigated the efficacy of carvedilol in the inhibition of ANT-induced cardiotoxicity . Methods : In this r and omized , single-blind , placebo-controlled study , 91 women with recently diagnosed breast cancer undergoing ANT therapy were r and omly assigned to groups treated with either carvedilol ( n = 46 ) or placebo ( n = 45 ) . Echocardiography was performed before and at 6 months after r and omization , and absolute changes in the mean left ventricular ejection fraction , left ventricular end diastolic volume , and left ventricular end systolic volume were determined . Furthermore , the percentage change in the left atrial ( LA ) diameter and other variables of left ventricular ( LV ) diastolic function , such as transmitral Doppler parameters , including early ( E wave ) and late ( A wave ) diastolic velocities , E/A ratio and E wave deceleration time , pulmonary venous Doppler signals , including forward systolic ( S wave ) and diastolic ( D wave ) velocities into LA , late diastolic atrial reversal velocity , and early diastolic tissue Doppler mitral annular velocity ( e ' ) were measured . In addition , tissue Doppler mitral annular systolic ( s ' ) velocity , as a marker of early stage of LV systolic dysfunction , E/e ' ratio , as a determinant of LV filling pressure , and troponin I level , as a marker of myocardial necrosis were measured . Results : At the end of follow-up period , left ventricular ejection fraction did not change in the carvedilol group . However , this parameter was significantly reduced in the control group ( P < 0.001 ) . Echocardiography showed that both left ventricular end systolic volume and LA diameter were significantly increased compared with the baseline measures in the control group . In pulse Doppler studies , pulmonary venous peak atrial reversal flow velocity was significantly increased in the control group . Moreover , a significant decrease in the mitral annuli early diastolic ( e ' ) and peak systolic ( s ' ) velocities and a significant increase in the E ( the peak early diastolic velocity)/e ' ratio in the control group were also observed . However , none of these variables were adversely changed at the end of follow-up in the carvedilol group . Furthermore , the TnI level was significantly higher in the control group than in the carvedilol group ( P = 0.036 ) at 30 days after the initiation of chemotherapy . Conclusions : Prophylactic use of carvedilol may inhibit the development of anthracycline-induced cardiotoxicity , even at low doses Abstract Aims Contemporary adjuvant treatment for early breast cancer is associated with improved survival but at the cost of increased risk of cardiotoxicity and cardiac dysfunction . We tested the hypothesis that concomitant therapy with the angiotensin receptor blocker c and esartan or the β-blocker metoprolol will alleviate the decline in left ventricular ejection fraction ( LVEF ) associated with adjuvant , anthracycline-containing regimens with or without trastuzumab and radiation . Methods and results In a 2 × 2 factorial , r and omized , placebo-controlled , double-blind trial , we assigned 130 adult women with early breast cancer and no serious co-morbidity to the angiotensin receptor blocker c and esartan cilexetil , the β-blocker metoprolol succinate , or matching placebos in parallel with adjuvant anticancer therapy . The primary outcome measure was change in LVEF by cardiac magnetic resonance imaging . A priori , a change of 5 percentage points was considered clinical ly important . There was no interaction between c and esartan and metoprolol treatments ( P = 0.530 ) . The overall decline in LVEF was 2.6 ( 95 % CI 1.5 , 3.8 ) percentage points in the placebo group and 0.8 ( 95 % CI −0.4 , 1.9 ) in the c and esartan group in the intention-to-treat analysis ( P-value for between-group difference : 0.026 ) . No effect of metoprolol on the overall decline in LVEF was observed . Conclusion In patients treated for early breast cancer with adjuvant anthracycline-containing regimens with or without trastuzumab and radiation , concomitant treatment with c and esartan provides protection against early decline in global left ventricular function BACKGROUND We aim ed to evaluate the effect of prophylactic nebivolol use on prevention of antracycline-induced cardiotoxicity in breast cancer patients . METHODS In this small , prospect i ve , double-blind study , we r and omly assigned 45 consecutive patients with breast cancer and planned chemotheraphy to receive nebivolol 5 mg daily ( n=27 ) or placebo ( n=18 ) . Echocardiographic measurements and N-terminal pro-brain natriuretic peptide ( NT-pro-BNP ) levels were obtained at baseline and at 6-month of chemotherapy . RESULTS Both studied groups had comparable echocardiographic variables and NT-pro-BNP levels at baseline . At 6-month , the left ventricular ( LV ) end-systolic and end-diastolic diameters increased in the placebo group ( LVESD : 29.7 ± 3.4 to 33.4 ± 4.5 mm ; LVEDD : 47.2 ± 3.8 to 52.0 ± 4.6 mm , p=0.01 for both ) but remained unchanged in the nebivolol group ( LVESD : 30.4 ± 3.5 to 31.0 ± 3.6 mm , p=0.20 ; LVEDD : 47.0 ± 4.4 to 47.1 ± 4.0 mm , p=0.93 ) . The placebo group also had lower LVEF than the nebivolol group ( 57.5 ± 5.6 % vs. 63.8 ± 3.9 % , p=0.01 ) at 6-month . NT-pro-BNP level remained static in the nebivolol group ( 147 ± 57 to 152 ± 69 pmol/l , p=0.77 ) while it increased in the placebo group ( 144 ± 66 to 204 ± 73 pmol/l , p=0.01 ) . CONCLUSIONS Prophylactic use of nebivolol treatment may protect the myocardium against antracycline-induced cardiotoxicity in breast cancer patients Background & objectives : Adriamycin though considered as an effective anticancer drug , leads to irreversible cardiomyopathy ( CMP ) and congestive heart failure ( CHF ) . The aim of this study was to determine the protective effect of carvedilol in adriamycin (ADR)-induced cardiomyopathy
Output:
| The prophylactic use of carvedilol exerted no impact on the early asymptomatic LVEF decrease but seemed to attenuate the frequency of clinical ly overt cardiotoxicity and prevent ventricular remodeling |
MS210986 | ***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: Oral healthcare providers have a clinical opportunity for early detection of disordered eating behaviors because they are often the first health professionals to observe overt oral and physical signs . Curricula regarding early recognition of this oral/systemic medical condition are limited in oral health educational programs . Web-based learning can supplement and reinforce traditional learning and has the potential to develop skills . The study purpose was to determine the efficacy of a theory-driven Web-based training program to increase the capacity of oral health students to perform behaviors related to the secondary prevention of disordered eating behaviors . Using the Reach , Effectiveness , Adoption , Implementation and Maintenance evaluation framework , a longitudinal group-r and omized controlled trial involving 27 oral health classes from 12 oral health education programs in the United States was implemented to assess the efficacy of the Web-based training on attitudes , knowledge , self-efficacy and skills related to the secondary prevention of disordered eating behaviors . Mixed-model analysis of covariance indicated substantial improvements among students in the intervention group ( effect sizes : 0.51 - 0.83 ) on all six outcomes of interest . Results suggest that the Web-based training program may increase the capacity of oral healthcare providers to deliver secondary prevention of disordered eating behaviors . Implication s and value of using the Reach , Effectiveness , Adoption , Implementation and Maintenance framework are discussed OBJECTIVE To determine if mothers receiving a smoking cessation intervention emphasizing health risks of environmental tobacco smoke ( ETS ) for their children have a higher quit rate than 1 ) mothers receiving routine smoking cessation advice or 2 ) a control group . DESIGN R and omized , controlled trial . SETTING Primary care center in a large urban children 's hospital . INTERVENTION Four hundred seventy-nine mothers were r and omly assigned to a smoking cessation intervention either aim ed at their child 's health or their own health , or to a control group receiving safety information . OUTCOME MEASURES Smoking status , stage of change , cigarettes/day , location smoking occurred , and knowledge of ETS effects . RESULTS Complete data ( baseline and both follow-ups ) were available for 166 subjects . There was no impact of group assignment on the quit rate , cigarettes/day , or stage of change . The Child Health Group intervention had a sustained effect on location where smoking reportedly occurred ( usually outside ) and on improved knowledge of ETS effects . CONCLUSIONS Further research is needed to devise more effective methods of using the pediatric health care setting to influence adult smoking behaviors This study examined the value of SLT as a model for predicting levels of dental hygiene behaviors . The brushing and flossing frequency of 131 adults was measured both retrospectively ( via question naire ) and prospect ively ( via self-monitoring records ) . Two types of SLT variables -- expectations and environmental influences -- were reliably related to dental hygiene behaviors . Such variables ( for example , self-efficacy expectations and the dental behaviors of significant others ) accounted for up to 38 % of the variance in brushing frequency and 33 % of the variance in flossing frequency . Overall , a SLT model appears to hold promise for identifying psychosocial variables that are related to dental hygiene behaviors . The findings suggest that educational programs intended to increase the frequency of such behaviors should focus on increasing self-efficacy , reducing structural and life-style barriers to adherence , and involving significant others in educational efforts AIM Because patient adherence to oral hygiene is essential for periodontal treatment success , the aim of the study was to assess whether a motivational interview addressing the five dimensions of Leventhal 's theory performed better than conventional basic instruction on improving compliance with plaque control among patients with periodontitis . MATERIAL S AND METHODS A r and omized controlled clinical trial design was used in which a group of patients underwent a motivational interview in addition to classical consultation . A control group received only the st and ard consultation . The O'Leary Plaque Index was used to judge the oral hygiene at baseline and at 1 month follow-up . Patient satisfaction with the dental visit was scored using a specific question naire . RESULTS At baseline , the mean full mouth plaque score varied between 55 % ( experimental group ) and 58 % ( control group ) . Patients in the experimental group had a higher oral hygiene improvement ( 21 ± 20 % versus 4 ± 5 % , p < 0.001 ) 1 month post-treatment . The motivational interview result ed in greater satisfaction scores compared with those of patients in the control group : 10.55 ± 1.53 versus 8.82 ± 2.40 , p = 0.014 . CONCLUSIONS This new concept of motivational interview is a promising approach and can be useful for counselling-related periodontal disorders AIM To evaluate the effectiveness of an individually tailored oral health educational programme for oral hygiene self-care in patients with chronic periodontitis compared with the st and ard treatment . MATERIAL AND METHOD A r and omized , evaluator-blinded , controlled trial with two different active treatments were used with 113 subjects ( 60 females and 53 males ) r and omly allocated to an experimental or a control group . The individually tailored oral health educational programme was based on cognitive behavioural principles and the individual tailoring for each participant was based on participants ' thoughts , intermediate , and long-term goals , and oral health status . The effect of the programmes on gingivitis [ gingival index ( GI ) ] , oral hygiene [ plaque indices ( PlI ) and self-report ] , and participants ' global rating of treatment was evaluated 3 and 12 months after oral health education and non-surgical treatment . RESULTS Between baseline and the 12-month follow-up , the experimental group improved both GI and PlI more than the control group . The mean gain-score difference was 0.27 for global GI [ 99.2 % confidence interval ( CI ) : 0.16 - 0.39 , p<0.001 ] and 0.40 for proximal GI ( 99.2 % CI : 0.27 - 0.53 , p<0.001 ) . The mean gain-score difference was 0.16 for global PlI ( 99.2 % CI : 0.03 - 0.30 , p=0.001 ) , and 0.26 for proximal PlI ( 99.2 % CI : 0.10 - 0.43 , p<0.001 ) . The subjects in the experimental group reported a higher frequency of daily inter-dental cleaning and were more certain that they could maintain the attained level of behaviour change . CONCLUSION The individually tailored oral health educational programme was efficacious in improving long-term adherence to oral hygiene in periodontal treatment . The largest difference was for interproximal surfaces Parents and school staff play important roles in promoting children 's oral health . Our study goals were to investigate whether an intervention targeting parents and school staff can improve the oral-health behavior and oral-health status of schoolchildren . Three-hundred and ninety-two schoolchildren in six schools in Tehran participated in a group r and omized trial from September 2010 to March 2011 . Schools were r and omly allocated into three groups : comprehensive , student , and control . Intervention in the comprehensive group consisted of strategies to encourage children , their parents , and school staff to increase the frequency of toothbrushing and flossing . In the student group , the intervention targeted only children . The control group received no intervention . The primary outcome was change in oral-health behaviors ( brushing and flossing ) , while the secondary outcomes were changes in oral hygiene and Community Periodontal indices and in Health Belief Model components . Multilevel modeling was employed for data analyses . Students who were in the comprehensive intervention group brushed and flossed significantly more frequently compared with those in the student intervention group . Although students ' gingival health improved significantly in the comprehensive intervention group , such significant improvement was not seen in the student group . In conclusion , promising results are seen when the oral-health education targets both school and home setting Considerable re sources are expended in dealing with dental disease easily prevented with better oral hygiene . The study hypothesis was that an evidence -based intervention , framed with psychological theory , would improve patients ’ oral hygiene behavior . The impact of trial methodology on trial outcomes was also explored by the conducting of two independent trials , one r and omized by patient and one by dentist . The study included 87 dental practice s and 778 patients ( Patient RCT = 37 dentists/300 patients ; Cluster RCT = 50 dentists/478 patients ) . Controlled for baseline differences , pooled results showed that patients who experienced the intervention had better behavioral ( timing , duration , method ) , cognitive ( confidence , planning ) , and clinical ( plaque , gingival bleeding ) outcomes . However , clinical outcomes were significantly better only in the Cluster RCT , suggesting that the impact of trial design on results needs to be further explored OBJECTIVES This clinical trial study investigates whether a behavioural educational intervention based on the autoregulation theory can improve periodontitis patients ' compliance with proper dental care at a 1-month follow-up . MATERIAL AND METHODS Thirty patients matched for gender ( 20 men ) , age ( mean age=39 years ) and education were r and omly assigned to a control or an experimental treatment condition . In the control condition , patients received the regular treatment based on instruction of the proper prophylactic dental care . In the experimental treatment condition , patients received information about the symptoms of periodontitis , the causes , consequences and temporal course , and the types of effective strategy and they were requested to keep daily records of the effects of applying prophylactic dental care on their periodontitis symptoms . In both groups , plaque indices ( PIs ) ( Silness & Löe 1964 ) were measured prior to treatment and at a 1-month follow-up . A self-report question naire also assessed the representation of periodontitis in all patients . RESULTS A 2 ( time of measurement : baseline versus follow-up ) x 3 ( PI localization ) x 2 ( experimental group ) mixed- design anova computed on the PI reports a large effect of time , F(1 , 28)=267.10 , p<0.000 , indicating that both groups improved from baseline ( mean=1.73 , SD=0.08 ) to the 1-month follow-up ( mean=0.56 , SD=0.06 ) . It is important to point out that this analysis also revealed the expected Group x Time interaction , F(1 , 28)=7.09 , p<0.02 , partial eta(2)=0.19 , indicating that smaller PI were observed in the experimental group ( mean=0.24 , SD=0.14 ) than in the control group ( mean=0.88 , SD=0.38 ) at follow-up . Post hoc analyses showed that this pattern applies to the proximal and lingual PI but not to the vestibular PI . CONCLUSIONS The present data show that the behavioural education intervention is ( a ) more effective than a classical intervention based on information and training about prophylactic techniques and ( b ) that it is effective in bringing most patients to normal levels of PI . For clinical practice , it suggests that better results can be obtained if ( a ) patients are taught a correct representation about periodontitis and ( b ) patients ' sense of self-efficacy is developed through their own direct experience , by observing the effects of their behaviour on periodontitis symptoms AIMS / OBJECTIVES To determine the benefit of twice daily toothbrushing on newly erupted first permanent molars . To investigate , through the Health Belief Model , how parents ' beliefs influence the likelihood of their children brushing twice a day . To identify aspects of a toothbrushing intervention programme that can be used in general dental practice . DESIGN R and omised controlled trial . SETTING Schools in deprived communities in Scotl and . PARTICIPANTS 461 , 5-year-old children . INTERVENTIONS / METHODS Supervised toothbrushing on school-days with a 1,000 ppm chalk-based fluoride toothpaste for two years . A school and home-based incentive scheme including toothbrushing charts , 6-monthly dental examinations and parental question naires . MAIN OUTCOME MEASURES Caries increment and twice daily toothbrushing . RESULTS In the control group , children who brushed once a day or less had 64 % more caries than those who brushed at least twice a day ( P = 0.001 ) . In the intervention group this difference in caries was reduced to 16 % ( P > 0.05 ) . The most significant parental belief explaining variation in twice-daily brushing was whether parents feel strongly that there is time to check their child 's toothbrushing ( P = 0.0001 ) . The odds of these parents reporting that their child brushes twice daily are nearly three times greater . 95 % of parents felt that toothbrushing charts would be a good way for dentists in practice to encourage children to brush regularly . CONCLUSIONS The benefit of twice daily toothbrushing on caries development in newly erupted first permanent molar teeth is around 50 % compared to brushing once a day or less . Parents ' beliefs do influence the likelihood of their children brushing twice a day . Key parts of the intervention programme can be used when children attend general dental practice and would be welcomed by parents BACKGROUND Oral health education for the mothers of very young children is important in reducing the risk of early childhood caries . This study aim ed to evaluate the impact of an oral health intervention among mothers of 1 - 2 years old children . METHODS This cluster r and omized controlled trial ( 2012 ) was conducted among ninety mothers of 1 - 2 year old children . The setting of study was 10 child day-care centers out of 18 in Hamadan , western Iran . Day-care centers were r and omly allocated into two groups : an intervention group ( 5 day-care centers , 45 mothers ) and a control group ( 5 day-care
Output:
| CONCLUSION The current meta- analysis showed that in general , psychological interventions that used OT , CT , HBM and TPB were effective in enhancing oral health status , and interventions that used SCT did not have an effect on improving oral health status . |
MS210987 | ***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: Aim We assessed the management and outcomes of non-ST segment elevation myocardial infa rct ion ( NSTEMI ) patients r and omly assigned to fractional flow reserve (FFR)-guided management or angiography-guided st and ard care . Methods and results We conducted a prospect i ve , multicentre , parallel group , 1 : 1 r and omized , controlled trial in 350 NSTEMI patients with ≥1 coronary stenosis ≥30 % of the lumen diameter assessed visually ( threshold for FFR measurement ) ( NCT01764334 ) . Enrolment took place in six UK hospitals from October 2011 to May 2013 . Fractional flow reserve was disclosed to the operator in the FFR-guided group ( n = 176 ) . Fractional flow reserve was measured but not disclosed in the angiography-guided group ( n = 174 ) . Fractional flow reserve ≤0.80 was an indication for revascularization by percutaneous coronary intervention ( PCI ) or coronary artery bypass surgery ( CABG ) . The median ( IQR ) time from the index episode of myocardial ischaemia to angiography was 3 ( 2 , 5 ) days . For the primary outcome , the proportion of patients treated initially by medical therapy was higher in the FFR-guided group than in the angiography-guided group [ 40 ( 22.7 % ) vs. 23 ( 13.2 % ) , difference 95 % ( 95 % CI : 1.4 % , 17.7 % ) , P = 0.022 ] . Fractional flow reserve disclosure result ed in a change in treatment between medical therapy , PCI or CABG in 38 ( 21.6 % ) patients . At 12 months , revascularization remained lower in the FFR-guided group [ 79.0 vs. 86.8 % , difference 7.8 % ( −0.2 % , 15.8 % ) , P = 0.054 ] . There were no statistically significant differences in health outcomes and quality of life between the groups . Conclusion In NSTEMI patients , angiography-guided management was associated with higher rates of coronary revascularization compared with FFR-guided management . A larger trial is necessary to assess health outcomes and cost-effectiveness Background There are conflicting data regarding optimal treatment of non-culprit lesions detected during primary percutaneous coronary intervention ( PCI ) in patients with ST-elevation myocardial infa rct ion ( STEMI ) and multi-vessel disease ( MVD ) . We aim ed to investigate whether ischaemia-driven early invasive treatment improves the long-term outcome and prevents major adverse cardiac events ( MACE ) . Methods 121 patients with at least one non-culprit lesion were r and omised in a 2:1 manner , 80 were r and omised to early fractional flow reserve (FFR)-guided PCI ( invasive group ) , and 41 to medical treatment ( conservative group ) . The primary endpoint was MACE at 3 years . Results Three-year follow-up was available in 119 patients ( 98.3 % ) . There was no significant difference in all-cause mortality between the invasive and conservative strategy , 4 patients ( 3.4 % ) died , all in the invasive group ( P = 0.29 ) . Re-infa rct ion occurred in 14 patients ( 11.8 % ) in the invasive group versus none in the conservative group ( p = 0.002 ) . Re-PCI was performed in 7 patients ( 8.9 % ) in the invasive group and in 13 patients ( 32.5 % ) in the conservative group ( P = 0.001 ) . There was no difference in MACE between these two strategies ( 35.4 vs 35.0 % , p = 0.96 ) . Conclusions In STEMI patients with MVD , early FFR-guided additional revascularisation of the non-culprit lesion did not reduce MACE at three-year follow-up compared with a more conservative strategy . The rate of MACE in the invasive group was predominantly driven by death and re-infa rct ion , whereas in the conservative group the rate of MACE was only driven by repeat interventions OBJECTIVES The purpose of this study was to investigate the 2-year outcome of percutaneous coronary intervention ( PCI ) guided by fractional flow reserve ( FFR ) in patients with multivessel coronary artery disease ( CAD ) . BACKGROUND In patients with multivessel CAD undergoing PCI , coronary angiography is the st and ard method for guiding stent placement . The FAME ( Fractional Flow Reserve Versus Angiography for Multivessel Evaluation ) study showed that routine FFR in addition to angiography improves outcomes of PCI at 1 year . It is unknown if these favorable results are maintained at 2 years of follow-up . METHODS At 20 U.S. and European medical centers , 1,005 patients with multivessel CAD were r and omly assigned to PCI with drug-eluting stents guided by angiography alone or guided by FFR measurements . Before r and omization , lesions requiring PCI were identified based on their angiographic appearance . Patients r and omized to angiography-guided PCI underwent stenting of all indicated lesions , whereas those r and omized to FFR-guided PCI underwent stenting of indicated lesions only if the FFR was < or=0.80 . RESULTS The number of indicated lesions was 2.7+/-0.9 in the angiography-guided group and 2.8+/-1.0 in the FFR-guided group ( p=0.34 ) . The number of stents used was 2.7+/-1.2 and 1.9+/-1.3 , respectively ( p<0.001 ) . The 2-year rates of mortality or myocardial infa rct ion were 12.9 % in the angiography-guided group and 8.4 % in the FFR-guided group ( p=0.02 ) . Rates of PCI or coronary artery bypass surgery were 12.7 % and 10.6 % , respectively ( p=0.30 ) . Combined rates of death , nonfatal myocardial infa rct ion , and revascularization were 22.4 % and 17.9 % , respectively ( p=0.08 ) . For lesions deferred on the basis of FFR>0.80 , the rate of myocardial infa rct ion was 0.2 % and the rate of revascularization was 3.2 % after 2 years . CONCLUSIONS Routine measurement of FFR in patients with multivessel CAD undergoing PCI with drug-eluting stents significantly reduces mortality and myocardial infa rct ion at 2 years when compared with st and ard angiography-guided PCI . ( Fractional Flow Reserve Versus Angiography for Multivessel Evaluation [ FAME ] ; NCT00267774 ) Background — Magnetic resonance myocardial perfusion imaging ( MRMPI ) has a number of advantages over the other noninvasive tests used to detect reversible myocardial ischemia . The majority of previous studies have generally used quantitative coronary angiography as the gold st and ard to assess the accuracy of MRMPI ; however , only an approximate relationship exists between stenosis severity and functional significance . Pressure wire – derived fractional flow reserve ( FFR ) values < 0.75 correlate closely with objective evidence of reversible ischemia . Accordingly , we have compared MRMPI with FFR . Methods and Results — One hundred three patients referred for investigation of suspected angina underwent MRMPI with a 1.5-T scanner . The stress agent was intravenous adenosine ( 140 & mgr;g · kg−1 · min−1 ) , and the first-pass bolus contained 0.1 mmol/kg gadolinium . In the following week , coronary angiography with pressure wire studies was performed . FFR was recorded in all patent major epicardial coronary arteries , with a value < 0.75 denoting significant stenosis . MRMPI scans , analyzed by 2 blinded observers , identified perfusion defects in 121 of 300 coronary artery segments ( 40 % ) , of which 110 had an FFR < 0.75 . We also found that 168 of 179 normally perfused segments had an FFR ≥0.75 . The sensitivity and specificity of MRMPI for the detection of functionally significant coronary heart disease were 91 % and 94 % , respectively , with positive and negative predictive values of 91 % and 94 % . Conclusion — MRMPI can detect functionally significant coronary heart disease with excellent sensitivity , specificity , and positive and negative predictive values compared with FFR Background Few reports described outcomes of complete compared with infa rct -related artery (IRA)-only revascularisation in patients with ST-elevation myocardial infa rct ion ( STEMI ) and multivessel coronary artery disease ( CAD ) . Moreover , no studies have compared the simultaneous treatment of non-IRA with the IRA treatment followed by an elective procedure for the other lesions ( staged revascularisation ) . Methods The outcomes of 214 consecutive patients with STEMI and multivessel CAD undergoing primary angioplasty were studied . Before the first angioplasty patients were r and omly assigned to three different strategies : culprit vessel angioplasty-only ( COR group ) ; staged revascularisation ( SR group ) and simultaneous treatment of non-IRA ( CR group ) . Results During a mean follow-up of 2.5 years , 42 ( 50.0 % ) patients in the COR group experienced at least one major adverse cardiac event ( MACE ) , 13 ( 20.0 % ) in the SR group and 15 ( 23.1 % ) in the CR group , p<0.001 . Inhospital death , repeat revascularisation and re-hospitalisation occurred more frequently in the COR group ( all p<0.05 ) , whereas there was no significant difference in re-infa rct ion among the three groups . Survival free of MACE was significantly reduced in the COR group but was similar in the CR and SR groups . Conclusions Culprit vessel-only angioplasty was associated with the highest rate of long-term MACE compared with multivessel treatment . Patients scheduled for staged revascularisation experienced a similar rate of MACE to patients undergoing complete simultaneous treatment of non-IRA AIMS To examine the incidence of and propensity for non-culprit interventions performed at the time of the primary percutaneous coronary intervention ( PCI ) and its association with 90-day outcomes . METHODS AND RESULTS We examined the incidence , propensity for , and associated 90-day outcomes following non-culprit interventions performed at the time of primary PCI among ST-elevation myocardial infa rct ion patients with multi-vessel coronary artery disease ( MVD ) . Of the 5373 patients who underwent primary PCI in the APEX-AMI trial , 2201 had MVD . Of those , 217 ( 9.9 % ) underwent non-infa rct -related arteries ( IRA ) PCI , whereas 1984 ( 90.1 % ) underwent PCI of the IRA alone . Ninety-day death and death/CHF/shock were higher in the non-IRA group compared with the IRA-only PCI group ( 12.5 vs. 5.6 % , P ( log-rank ) < 0.001 and 17.4 vs. 12.0 % , P ( log-rank ) = 0.020 , respectively ) . After adjusting for patient and procedural characteristics as well as propensity for performing non-IRA PCI , this procedure remained independently associated with an increased hazard of 90-day mortality [ adjusted hazard ratio 2.44 , 95 % CI ( 1.55 - 3.83 ) , P < 0.001 ] . CONCLUSION Non-culprit coronary interventions were performed at the time of primary PCI in 10 % of MVD patients and were significantly associated with increased mortality . Our data support current guideline recommendations discouraging the performance of such procedures in stable primary PCI patients . Prospect i ve r and omized study of this issue may be warranted BACKGROUND Non-infa rct -related artery ( non-IRA ) disease is prevalent in patients with ST-segment elevation myocardial infa rct ion ( STEMI ) . We aim ed to assess the impact of non-IRA disease on infa rct size and clinical outcomes in patients with acute STEMI . METHODS The Counterpulsation to Reduce Infa rct Size Pre-PCI Acute Myocardial Infa rct ion ( CRISP-AMI ) trial r and omized patients to intra-aortic balloon counterpulsation ( IABC ) vs no IABC prior to percutaneous coronary intervention in patients with acute STEMI . Infa rct size ( % left ventricular mass ) at 3 - 5 days post percutaneous coronary intervention and 6-month clinical outcomes were compared between patients with and without non-IRA disease ( defined as ≥50 % stenosis in at least one non-IRA ) . RESULTS A total of 324 ( 96.1 % ) patients had anterior STEMI , of whom 34.9 % had non-IRA disease . There was no difference in infa rct size ( % left ventricular mass ) between patients with and without non-IRA disease ( median 39 % vs 39 % ; P = .73 ) . At 6 months , there was no difference in rates of recurrent myocardial infa rct ion ( 0.9 % vs 0.9 % ; P = .78 ) , major Thrombol
Output:
| Conclusions In patients with STEMI and MVD , FFR-guided CR is better than COR in terms of MACE and ischemia-driven repeat revascularization , while there are almost similar in all-cause mortality . |
MS210988 | ***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: E7070 is a novel sulfonamide anticancer agent that disrupts the G1/S phase of the cell cycle . The objectives of this phase I study of E7070 were to estismate the maximal tolerated dose ( MTD ) , to determine the recommended dose for phase II , and to clarify the pharmacokinetic profile of E7070 and its relation to polymorphisms of CYP2C9 ( * 2 , * 3 ) and CYP2C19 ( * 2 , * 3 ) in Japanese patients . Patients received 1–2‐h i.v . infusions of E7070 ( 400 , 600 , 700 , 800 or 900 mg/m2 ) on day 1 of a 21‐day cycle . Twenty‐one patients received between one and eight cycles of E7070 . The dose‐limiting toxicities ( DLT ) comprised leukopenia , neutropenia , thrombocytopenia , elevation of aspartate aminotransferase , colitis , and ileus . The mean area under the plasma concentration – time curve ( AUC ) for successive dose levels increased in a non‐dose‐proportional manner . Two patients were heterozygous for the CYP2C9 mutation . For CYP2C19 , eight patients were wild type and the remainder had heterozygous ( n = 8) or homozygous mutations ( n = 5 ) . Regarding the CYP2C19 genotype , the AUC of patients with mutant alleles were higher than those of patients with wild type at a dose of 600 mg/m2 or more . The severity of toxic effects , such as myelosuppression , seemed to depend on the AUC . No partial responses were observed . One patient treated at a dose of 700 mg/m2 experienced a maximum tumor volume reduction of 22.5 % . The MTD was estimated to be 900 mg/m2 . A dose of 800 mg/m2 is recommended for further phase II studies . The pharmacokinetic/pharmacodynamic properties of E7070 seemed to be influenced by CYP2C19 genotype . The observed safety profile and preliminary evidence of antitumor activity warrant further investigation of this drug in monotherapy or in combination chemotherapy . ( Cancer Sci 2005 ; 96 : 721 –728 Background The selection of patients according to key genetic characteristics may help to tailor chemotherapy and optimize the treatment in Castration-Resistant Prostate Cancer ( CRPC ) patients . Functional polymorphisms within the cytochrome P450 1B1 ( CYP1B1 ) gene have been associated with alterations in enzymatic expression and activity and may change sensitivity to the widely used docetaxel regimen . Methods CYP1B1 genotyping was performed on blood sample s of 60 CRPC patients treated with docetaxel , using TaqMan probes-based assays . Association between CYP1B1 - 142C > G ( leading to the 48ArgGly transition ) , 4326C > G ( 432LeuVal ) , and 4390A > G ( 453AsnSer ) polymorphisms and treatment response , progression-free-survival ( PFS ) and overall-survival ( OS ) was estimated using Pearson χ2 test , Kaplan-Meier curves and Log-rank test . Results Patients carrying the CYP1B1 - 432ValVal genotype experienced a significantly lower response-rate ( P = 0.014 ) , shorter progression-free-survival ( P = 0.032 ) and overall-survival ( P < 0.001 ) . Multivariate analyses and correction for multiple comparisons confirmed its prognostic significance for OS . No significant associations were found among other polymorphisms and both response and clinical outcome . Conclusions CYP1B1 - 4326C > G ( 432LeuVal ) polymorphism emerged as possible predictive marker of response and clinical outcome to docetaxel in CRPC patients and may represent a potential new tool for treatment optimization . Larger prospect i ve trials are warranted to vali date these findings , which might be applied to the future practice of CRPC treatment Introduction Aromatase inhibitor-associated arthralgia ( AIAA ) is a common and often debilitating symptom in breast cancer survivors . Since joint symptoms have been related to estrogen deprivation through the menopausal transition , we hypothesized that genetic polymorphisms in CYP19A1 , the final enzyme in estrogen synthesis , may be associated with the occurrence of AIAA . Methods We performed a cross-sectional study of postmenopausal women with stage 0 to III breast cancer receiving adjuvant aromatase inhibitor ( AI ) therapy . Patient-reported AIAA was the primary outcome . DNA was genotyped for c and i date CYP19A1 polymorphisms . Serum estrogen levels were evaluated by radioimmunoassay . Multivariate analyses were performed to examine associations between AIAA and genetic variants controlling for possible confounders . Results Among 390 Caucasian participants , 50.8 % reported AIAA . Women carrying at least one 8-repeat allele had lower odds of AIAA ( adjusted odds ratio ( AOR ) 0.41 , 95 % confidence interval ( CI ) 0.21 to 0.79 , P = 0.008 ) after adjusting for demographic and clinical covariates . Estradiol and estrone were detectable in 47 % and 86 % of subjects on AIs , respectively . Although these post-AI levels were associated with multiple genotypes , they were not associated with AIAA . In multivariate analyses , women with more recent transition into menopause ( less than five years ) were significantly more likely to report AIAA than those greater than ten years post-menopause ( AOR 3.31 , 95 % CI 1.72 to 6.39 , P < 0.001 ) . Conclusions Functional polymorphism in CYP19A1 and time since menopause are associated with patient-reported AIAA , supporting the hypothesis that the host hormonal environment contributes to the pathophysiology of AAIA . Prospect i ve investigation is needed to further delineate relationships between host genetics , changing estrogen levels and AIAA Introduction Tamoxifen therapy reduces the risk of recurrence and prolongs the survival of oestrogen-receptor-positive patients with breast cancer . Even if most patients benefit from tamoxifen , many breast tumours either fail to respond or become resistant . Because tamoxifen is extensively metabolised by polymorphic enzymes , one proposed mechanism underlying the resistance is altered metabolism . In the present study we investigated the prognostic and /or predictive value of functional polymorphisms in cytochrome P450 3A5 CYP3A5 ( * 3 ) , CYP2D6 ( * 4 ) , sulphotransferase 1A1 ( SULT1A1 ; * 2 ) and UDP-glucuronosyltransferase 2B15 ( UGT2B15 ; * 2 ) in tamoxifen-treated patients with breast cancer . Methods In all , 677 tamoxifen-treated postmenopausal patients with breast cancer , of whom 238 were r and omised to either 2 or 5 years of tamoxifen , were genotyped by using PCR with restriction fragment length polymorphism or PCR with denaturing high-performance liquid chromatography . Results The prognostic evaluation performed in the total population revealed a significantly better disease-free survival in patients homozygous for CYP2D6 * 4 . For CYP3A5 , SULT1A1 and UGT2B15 no prognostic significance was observed . In the r and omised group we found that for CYP3A5 , homozygous carriers of the * 3 allele tended to have an increased risk of recurrence when treated for 2 years with tamoxifen , although this was not statistically significant ( hazard ratio ( HR ) = 2.84 , 95 % confidence interval ( CI ) = 0.68 to 11.99 , P = 0.15 ) . In the group r and omised to 5 years ' tamoxifen the survival pattern shifted towards a significantly improved recurrence-free survival ( RFS ) among CYP3A5 * 3-homozygous patients ( HR = 0.20 , 95 % CI = 0.07 to 0.55 , P = 0.002 ) . No reliable differences could be seen between treatment duration and the genotypes of CYP2D6 , SULT1A1 or UGT2B15 . The significantly improved RFS with prolonged tamoxifen treatment in CYP3A5 * 3 homozygotes was also seen in a multivariate Cox model ( HR = 0.13 , CI = 0.02 to 0.86 , P = 0.03 ) , whereas no differences could be seen for CYP2D6 , SULT1A1 and UGT2B15 . Conclusion The metabolism of tamoxifen is complex and the mechanisms responsible for the resistance are unlikely to be explained by a single polymorphism ; instead it is a combination of several mechanisms . However , the present data suggest that genetic variation in CYP3A5 may predict response to tamoxifen therapy Purpose : P-glycoprotein , encoded by the mdr-1 gene , confers multidrug resistance to a variety of antineoplastic agents , e.g. , paclitaxel . Recently , different polymorphisms in the mdr-1 gene have been identified and their consequences for the function of P-glycoprotein , as well as for the treatment response to P-glycoprotein substrates , are being clarified . We analyzed the allelic frequencies at polymorphic sites G2677T/A and C3435 T in ovarian cancer patients with good or poor response to treatment with paclitaxel in combination with carboplatin in order to evaluate their predictive values . Experimental Design : Fifty-three patients were included in the study ; 28 of them had been relapse-free for at least 1 year and 25 had progressive disease or relapsed within 12 months . A reference material consisting of 200 individuals was also analyzed . The genotypes of each single nucleotide polymorphism ( SNP ) were determined using Pyrosequencing . Results : The G2677T/A SNP was found to significantly correlate with treatment outcome . The probability of responding to paclitaxel treatment was higher in homozygously mutated patients ( T/T or T/A ; Fisher 's exact test ; P < 0.05 ) . The frequency of the T or A alleles was also higher in the group of patients who had a good response ( P < 0.05 ) . There was also a dose-dependent influence of the number of mutated alleles on the response to paclitaxel treatment ( χ2 test for linear-by-linear association ; P = 0.03 ) . However , the C3435 T SNP was not found to correlate to treatment outcome . Conclusions : The mdr-1 polymorphism G2677T/A in exon 21 correlates with the paclitaxel response in ovarian cancer and may be important for the function of P-glycoprotein and resistance to paclitaxel and provide useful information for individualized therapy For infants and very young children with brain tumors , chemotherapy after surgical resection is the main treatment due to neurologic and neuroendocrine adverse effects from whole brain irradiation . Topotecan , an anticancer drug with antitumor activity against pediatric brain tumors , can be given intravenous or orally . However , high interpatient variability in oral drug bioavailability is common in children less than 3 years old . Therefore , this study aim ed to determine the population pharmacokinetics of oral topotecan in infants and very young children , specifically evaluating the effects of age and ABCG2 and ABCB1 on the absorption rate constant ( Ka ) , as well as other covariate effects on all pharmacokinetic parameters . A nonlinear mixed effects model was implemented in Monolix 4.3.2 ( Lixoft , Orsay , France ) . A one-compartment model with first-order input and first-order elimination was found to adequately characterize topotecan lactone concentrations with population estimates as [ mean ( S.E. ) ] ; Ka = 0.61 ( 0.11 ) h−1 , apparent volume of distribution ( V/F ) = 40.2 ( 7.0 ) l , and apparent clearance ( CL/F ) = 40.0 ( 2.9 ) l/h . After including the body surface area in the V/F and CL/F as a power model centered on the population median , the ABCG2 rs4148157 allele was found to play a significant role in the value of Ka . Patients homozygous or heterozygous for G > A demonstrated a Ka value 2-fold higher than their GG counterparts , complemented with a 2-fold higher maximal concentration as well . These results demonstrate a possible role for the ABCG2 rs4148157 allele in the pharmacokinetics of oral topotecan in infants and very young children , and warrants further investigation Objective This study aim ed to explore the influence of SLC22A1 , PXR , ABCG2 , ABCB1 and CYP3A5 * 3 genetic polymorphisms on imatinib mesylate ( IM ) pharmacokinetics in Asian patients with chronic myeloid leukemia ( CML ) . Patients and Methods Healthy subjects belonging to three Asian population s ( Chinese , Malay , Indian ; n = 70 each ) and CML patients ( n = 38 ) were enrolled in a prospect i ve pharmacogenetics study . Imatinib trough ( C0h ) and clearance ( CL ) were determined in the patients at steady state . Haplowalk method was applied to infer the haplot
Output:
| Nevertheless , among the investigated gene polymorphisms , it appears that the 1236C > T , 3435C > T and 2677 G > T/A SNPs of the drug transporter gene ABCB1 were the most promising determinants of clinical outcomes .
Therefore , using the haplotype ( 1236C > T , 2677G > T , and 3435C > T ) analysis rather than a single SNP may be a more useful approach for phenotype prediction .
Some of the patients with variants of CYP genes were associated with unsatisfactory treatment response ( efficacy and toxicity ) , suggesting that these variants may be associated with either reduction or absence of CYP enzyme activity . |
MS210989 | ***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 To analyze hospital re source utilization for laparoscopic vs open incisional hernia repair including the postoperative period . METHODS Prospect ively collected administrative data for incisional hernia repairs were examined . A total of 884 incisional hernia repairs were examined for trends in type of approach over time . Starting October 2001 , detailed records were available , and examined for operating room ( OR ) time , cost data , length of stay ( LOS ) , and 30-day postoperative hospital encounters . RESULTS Of the total , 469 incisional hernias were approached laparoscopically ( 53 % ) and 415 open ( 47 % ) . Laparoscopic repair had shorter LOS ( 1 + /- 0.2 days vs 2 + /- 0.6 days ) , longer OR time ( 149 + /- 4 min vs 89 + /- 4 min ) , higher supply costs ( 2,237 dollars + /- 71 dollars vs 664 dollars + /- 113 dollars ) , slightly lower total hospital cost ( 6,396 dollars + /- 477 dollars vs 7,197 dollars + /- 1,819 dollars ) , and slightly more postoperative hospital encounters ( 15 % vs 13 % ) . Use of laparoscopy increased over time ( 37 % in 2000 vs 68 % in 2004 ) . CONCLUSIONS Laparoscopic incisional hernia repair is becoming increasingly popular , and not at increased cost to the health care system Objective : The aim of the trial was to compare laparoscopic technique with open technique regarding short-term pain , quality of life ( QoL ) , recovery , and complications . Background : Laparoscopic and open techniques for incisional hernia repair are recognized treatment options with pros and cons . Methods : Patients from 7 centers with a midline incisional hernia of a maximum width of 10 cm were r and omized to either laparoscopic ( LR ) or open sublay ( OR ) mesh repair . Primary end point was pain at 3 weeks , measured as the bodily pain subscale of Short Form-36 ( SF-36 ) . Secondary end points were complications registered by type and severity ( the Clavien-Dindo classification ) , movement restrictions , fatigue , time to full recovery , and QoL up to 8 weeks . Results : Patients were recruited between October 2005 and November 2009 . Of 157 r and omized patients , 133 received intervention : 64 LR and 69 OR . Measurements of pain did not differ , nor did movement restriction and postoperative fatigue . SF-36 subscales favored the LR group : physical function ( P < 0.001 ) , role physical ( P < 0.012 ) , mental health ( P < 0.022 ) , and physical composite score ( P < 0.009 ) . Surgical site infections were 17 in the OR group compared with 1 in the LR group ( P < 0.001 ) . The severity of complications did not differ between the groups ( P < 0.213 ) . Conclusions : Postoperative pain or recovery at 3 weeks after repair of midline incisional hernias does not differ between LR and OR , but the LR results in better physical function and less surgical site infections than the OR does . ( Clinical Trials.gov Identifier : NCT00472537 Background The laparoscopic approach has emerged in the search for a surgical technique to decrease the morbidity associated with conventional repair of ventral hernias . In this study we aim ed to compare the results of our open and laparoscopic ventral hernia repairs prospect ively . Methods Between January 2001 and October 2005 , a total of 46 patients diagnosed with ventral hernias ( primary and incisional ) who were admitted to our surgical unit and accepted to be included in this study group were examined . All patients were divided into laparoscopic repair ( n = 23 ) and open repair ( n = 23 ) subgroups in a r and omized fashion . The patients ’ demographic characteristics , operation times , body mass indices , sizes of fascial defects , hernia locations , duration s of hospital stay , presence and degrees of postoperative pain , and postoperative minor and major complications were analysed and compared . All the data were expressed as means ± SDs . Chi-square and Wilcoxon tests were used for statistical analysis , and P < 0.05 was accepted as a significant statistical value ( SPSS 11.0 for Windows ) . Results The demographic characteristics of both groups were similar . Women predominated , especially in the laparoscopy group ( P < 0.05 ) . The comparison of the results revealed that the major advantage of laparoscopy was the shortened postoperative hospital stay and the reduced incidence of mesh infection ( P < 0.05 , P < 0.05 ) . On the other h and , operation time was significantly longer in the laparoscopy group ( P < 0.05 ) . The major complications encountered in the laparoscopy group were ileus and a missed enterotomy . The most frequent minor complication was seroma , which was significantly more frequent in the laparoscopy group ( P < 0.05 ) . Postoperative pain assessment revealed similar results in both groups ( P > 0.05 ) . Conclusions The laparoscopic approach appears to be as effective as open repairs in the treatment of ventral hernias . Advanced surgical skill , laparoscopic experience and high technology are m and atory factors for successful ventral hernia repair BACKGROUND The objective of this quasi experimental study was to compare the frequency of wound infection between open cholecystectomy ( OC ) and laparoscopic cholecystectomy ( LC ) conducted in Surgical Unit IV , Jinnah Hospital Lahore from June 2005 to January 2006 . METHODS 100 patients undergoing elective cholecystectomy for symptomatic gallstones were studied . The patients were allocated in the two groups of 50 each by simple r and om technique . Group-I underwent OC and Group-II underwent LC . The patients were then followed up for four weeks to pick up signs of wound infection . In case of infection , the degree of infection and the remedial measures done were documented and the results analysed . RESULTS In LC group there was only one case of Class-II wound infection i.e. 2 % . In case of OC there were three cases of wound infection i.e. 6 % . Out of these , two were of Class-IIl and one of Class-Il . CONCLUSION While there was no wound infection in cases of chronic Cholecystitis in both groups , the frequency of wound infection was three times as common in OC as compared to LC in Acute Cholecystitis/Empyema Objective : The objective of this study was to determine the best treatment of incisional hernia , taking into account recurrence , complications , discomfort , cosmetic result , and patient satisfaction . Background : Long-term results of incisional hernia repair are lacking . Retrospective studies and the midterm results of this study indicate that mesh repair is superior to suture repair . However , many surgeons are still performing suture repair . Methods : Between 1992 and 1998 , a multicenter trial was performed , in which 181 eligible patients with a primary or first-time recurrent midline incisional hernia were r and omly assigned to suture or mesh repair . In 2003 , follow-up was up date d. Results : Median follow-up was 75 months for suture repair and 81 months for mesh repair patients . The 10-year cumulative rate of recurrence was 63 % for suture repair and 32 % for mesh repair ( P < 0.001 ) . Abdominal aneurysm ( P = 0.01 ) and wound infection ( P = 0.02 ) were identified as independent risk factors for recurrence . In patients with small incisional hernias , the recurrence rates were 67 % after suture repair and 17 % after mesh repair ( P = 0.003 ) . One hundred twenty-six patients completed long-term follow-up ( median follow-up 98 months ) . In the mesh repair group , 17 % suffered a complication , compared with 8 % in the suture repair group ( P = 0.17 ) . Abdominal pain was more frequent in suture repair patients ( P = 0.01 ) , but there was no difference in scar pain , cosmetic result , and patient satisfaction . Conclusions : Mesh repair results in a lower recurrence rate and less abdominal pain and does not result in more complications than suture repair . Suture repair of incisional hernia should be ab and oned IMPORTANCE Incisional hernia is the most frequent surgical complication after laparotomy . Up to 30 % of all patients undergoing laparotomy develop an incisional hernia . OBJECTIVE To compare laparoscopic vs open ventral incisional hernia repair with regard to postoperative pain and nausea , operative results , perioperative and postoperative complications , hospital admission , and recurrence rate . DESIGN Multicenter r and omized controlled trial between May 1999 and December 2006 with a mean follow-up period of 35 months . SETTING All patients were operated on in a clinical setting at 1 of the 2 participating university medical centers or at the other 8 teaching hospitals . PARTICIPANTS Two hundred six patients from 10 hospitals were r and omized equally to laparoscopic or open mesh repair . Patients with an incisional hernia larger than 3 cm and smaller than 15 cm , either primary or recurrent , were included . Patients were excluded if they had an open abdomen treatment in their medical histories . INTERVENTION Laparoscopic or open ventral incisional hernia repair . MAIN OUTCOME MEASURES The primary outcome of the trial was postoperative pain . Secondary outcomes were use of analgesics , perioperative and postoperative complications , operative time , postoperative nausea , length of hospital stay , recurrence , morbidity , and mortality . RESULTS Median blood loss during the operation was significantly less ( 10 mL vs 50 mL ; P = .05 ) as well as the number of patients receiving a wound drain ( 3 % vs. 45 % ; P < .001 ) in the laparoscopic group . Operative time for the laparoscopic group was longer ( 100 minutes vs. 76 minutes ; P = .001 ) . Perioperative complications were significantly higher after laparoscopy ( 9 % vs. 2 % ) . Visual analog scale scores for pain and nausea , completed before surgery and 3 days and 1 and 4 weeks postoperatively , showed no significant differences between the 2 groups . At a mean follow-up period of 35 months , a recurrence rate of 14 % was reported in the open group and 18 % , in the laparoscopic group ( P = .30 ) . The size of the defect was found to be an independent predictor for recurrence ( P < .001 ) . CONCLUSIONS AND RELEVANCE During the operation , there was less blood loss and less need for a wound drain in the laparoscopic group . However , operative time was longer during laparoscopy . Perioperative complications were significantly higher in the laparoscopic group . Visual analog scores for pain and nausea did not differ between groups . The incidence of a recurrence was similar in both groups . The size of the defect was found to be an independent factor for recurrence of an incisional hernia BACKGROUND Laparoscopic repair of ventral incisional hernias has not been proved to be safer than open mesh repair . DESIGN Prospect i ve r and omized trial conducted between February 1 , 2004 , to January 31 , 2007 . SETTING Four Veterans Affairs medical centers . PARTICIPANTS One hundred sixty-two patients with ventral incisional hernias . INTERVENTIONS St and ardized laparoscopic or open repair . MAIN OUTCOME MEASURES Overall complication rates at 8 weeks and the odds of complications , adjusted for study site , body mass index , and hernia type . RESULTS Of the 162 r and omized patients , 146 underwent surgery ( 73 open and 73 laparoscopic repairs ) . Complications were less common in the laparoscopic group ( 23 patients [ 31.5 % ] ) compared with the open repair group ( 35 patients [ 47.9 % ] ; adjusted odds ratio [ AOR ] , 0.45 ; 95 % confidence interval [ CI ] , 0.22 - 0.91 ; P = .03 ) . Surgical site infection through 8 weeks was less common in the laparoscopic group ( 5.6 % vs 23.3 % ; AOR , 0.2 ; 95 % CI , 0.1 - 0.6 ) . The mean worst pain score in the laparoscopic group was 15.2 mm lower on a visual analog scale at 52 weeks ( 95 % CI , 1.0 - 29.3 ; P = .04 ) . Time to resume work activities was shorter for the laparoscopic group than for the open repair group ( median , 23.0 days vs 28.5 days ) , with an adjusted hazard ratio of 0.54 ( 95 % CI , 0.28 - 1.04 ; P = .06 ) . Overall recurrence at 2 years was 12.5 % in the laparoscopic group and 8.2 % in the open repair group ( AOR , 1.6 ; 95 % CI , 0.5 - 4.7 ; adjusted P = .44 ) . CONCLUSIONS Laparoscopic repair was associated with fewer
Output:
| Conclusions On the basis of our meta- analysis , we conclude that laparoscopic and open repair of incisional hernia is comparable . |
MS210990 | ***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: Overweight and obesity affects more than 66 % of the adult population and is associated with a variety of chronic diseases . Weight reduction reduces health risks associated with chronic diseases and is therefore encouraged by major health agencies . Guidelines of the National Heart , Lung , and Blood Institute ( NHLBI ) encourage a 10 % reduction in weight , although considerable literature indicates reduction in health risk with 3 % to 5 % reduction in weight . Physical activity ( PA ) is recommended as a component of weight management for prevention of weight gain , for weight loss , and for prevention of weight regain after weight loss . In 2001 , the American College of Sports Medicine ( ACSM ) published a Position St and that recommended a minimum of 150 min wk(-1 ) of moderate-intensity PA for overweight and obese adults to improve health ; however , 200 - 300 min wk(-1 ) was recommended for long-term weight loss . More recent evidence has supported this recommendation and has indicated more PA may be necessary to prevent weight regain after weight loss . To this end , we have reexamined the evidence from 1999 to determine whether there is a level at which PA is effective for prevention of weight gain , for weight loss , and prevention of weight regain . Evidence supports moderate-intensity PA between 150 and 250 min wk(-1 ) to be effective to prevent weight gain . Moderate-intensity PA between 150 and 250 min wk(-1 ) will provide only modest weight loss . Greater amounts of PA ( > 250 min wk(-1 ) ) have been associated with clinical ly significant weight loss . Moderate-intensity PA between 150 and 250 min wk(-1 ) will improve weight loss in studies that use moderate diet restriction but not severe diet restriction . Cross-sectional and prospect i ve studies indicate that after weight loss , weight maintenance is improved with PA > 250 min wk(-1 ) . However , no evidence from well- design ed r and omized controlled trials exists to judge the effectiveness of PA for prevention of weight regain after weight loss . Resistance training does not enhance weight loss but may increase fat-free mass and increase loss of fat mass and is associated with reductions in health risk . Existing evidence indicates that endurance PA or resistance training without weight loss improves health risk . There is inadequate evidence to determine whether PA prevents or attenuates detrimental changes in chronic disease risk during weight gain Goals of workProstate cancer patients receiving and rogen deprivation therapy ( ADT ) are vulnerable to a number of potentially debilitating side effects , which can significantly impact quality of life . The role of alternate therapies , such as physical activity ( PA ) , in attenuating these side effects is largely understudied for such a large population . Thus , the purpose of this study was to investigate the effects of PA intervention for men receiving ADT on PA behavior , quality of life , and fitness measures . Patients and methods One hundred participants were r and omized into an intervention ( n = 53 ) or a wait-list control group ( n = 47 ) , with 11 dropping out of the intervention group and 23 dropping out of the wait-list control group prior to post-testing . The intervention consisted of both an individually tailored home-based aerobic and light resistant training program and weekly group sessions . PA , quality of life , fitness , and physiological outcomes were assessed pre and post the 16-week intervention . Results Significant increases in PA , supported by changes in girth measures and blood pressure , support the beneficial impact of the intervention . Positive trends were also evident for depression and fatigue . However , due to the high dropout rate , these results must be interpreted with caution . Conclusions PA effectively attenuates many of the side effects of ADT and should be recommended to prostate survivors as an alternate therapy . Determining the maintenance of this behavior change will be important for underst and ing how the long-term benefits of increased activity levels may alleviate the late effects of ADT Advice to rest and take things easy if patients become fatigued during radiotherapy may be detrimental . Aerobic walking improves physical functioning and has been an intervention for chemotherapy‐related fatigue . A prospect i ve , r and omized , controlled trial was performed to determine whether aerobic exercise would reduce the incidence of fatigue and prevent deterioration in physical functioning during radiotherapy for localized prostate carcinoma And rogen-deprivation therapy ( ADT ) is a widely used treatment for prostate cancer . Recently , several studies have reported an association between ADT and an increased risk of cardiovascular events , including myocardial infa rct ion and cardiovascular mortality.1 - 5 These reports have led to increased interest and discussion regarding the metabolic effects of ADT and its possible association with increased cardiovascular risk . In addition , likely as a result of these reports , internists , endocrinologists , and cardiologists are now being consulted regarding the evaluation and management of patients in whom ADT is being initiated . Most of these physicians are not aware of the possible effects of ADT on cardiovascular risk factors or the issues regarding ADT and cardiovascular disease . Therefore , this multidisciplinary writing group has been commissioned to review and summarize the metabolic effects of ADT , to evaluate the data regarding a possible relation between ADT and cardiovascular events in patients with prostate cancer , and to generate suggestions regarding the evaluation and management of patients , both with and without known cardiac disease , in whom ADT is being initiated ( Table 1 ) . TABLE 1 Prospect i ve Studies of the Effects of ADT on Cardiac Risk Factors ADT was first used in prostate cancer for patients with overt metastatic disease,7 and it remains the mainstay of therapy for this group . ADT combined with external-beam radiation therapy is a st and ard of care in the treatment of men with high-risk prostate cancer , on the basis of evidence that shows a survival benefit in multiple r and omized controlled trials.8 - 13 However , ADT is also often used for other prostate cancer states ( eg , for prostate volume reduction in men planning to undergo definitive local therapy with brachytherapy , or in the case of rising prostate-specific antigen after definitive local treatment),14,15 and in these cases , its role in prolonging survival is less certain Background : Healthy lifestyle behaviors could have a role in ameliorating some of the adverse effects of and rogen suppression therapy ( AST ) in men with prostate cancer . The primary aim of this study was to assess the feasibility of a tapered supervised exercise program in combination with dietary advice in men with advanced prostate cancer receiving AST . Methods : Advanced prostate cancer patients receiving AST for a minimum of 6 months were r and omized to a 12-week lifestyle program comprising aerobic and resistance exercise , plus dietary advice ( n = 25 ) , or st and ard care ( n = 25 ) . Exercise behavior , dietary macronutrient intake , quality of life , fatigue , functional fitness , and biomarkers associated with disease progression were assessed at baseline , after the intervention , and at 6 months . Results : The lifestyle group showed improvements in exercise behavior ( P < 0.001 ) , dietary fat intake ( P = 0.001 ) , total energy intake ( P = 0.005 ) , fatigue ( P = 0.002 ) , aerobic exercise tolerance ( P < 0.001 ) , and muscle strength ( P = 0.033 ) compared with st and ard care controls . Although a high rate of attrition ( 44 % ) was observed at 6 months , the improvements in key health outcomes were sustained . No effects on clinical prostate cancer disease markers were observed . Conclusions : This preliminary evidence suggests that pragmatic lifestyle interventions have potential to evoke improvements in exercise and dietary behavior , in addition to other important health outcomes in men with advanced prostate cancer receiving AST . Impact : This study shows for the first time that pragmatic lifestyle interventions are feasible and could have a positive impact on health behaviors and other key outcomes in men with advanced prostate cancer receiving AST . Cancer Epidemiol Biomarkers Prev ; 20(4 ) ; 647–57 . © 2011 AACR PURPOSE To examine the effect of progressive resistance training on muscle function , functional performance , balance , body composition , and muscle thickness in men receiving and rogen deprivation for prostate cancer . METHODS Ten men aged 59 - 82 yr on and rogen deprivation for localized prostate cancer undertook progressive resistance training for 20 wk at 6- to 12-repetition maximum ( RM ) for 12 upper- and lower-body exercises in a university exercise rehabilitation clinic . Outcome measures included muscle strength and muscle endurance for the upper and lower body , functional performance ( repeated chair rise , usual and fast 6-m walk , 6-m backwards walk , stair climb , and 400-m walk time ) , and balance by sensory organization test . Body composition was measured by dual-energy x-ray absorptiometry and muscle thickness at four anatomical sites by B-mode ultrasound . Blood sample s were assessed for prostate specific antigen ( PSA ) , testosterone , growth hormone ( GH ) , cortisol , and hemoglobin . RESULTS Muscle strength ( chest press , 40.5 % ; seated row , 41.9 % ; leg press , 96.3 % ; P < 0.001 ) and muscle endurance ( chest press , 114.9 % ; leg press , 167.1 % ; P < 0.001 ) increased significantly after training . Significant improvement ( P < 0.05 ) occurred in the 6-m usual walk ( 14.1 % ) , 6-m backwards walk ( 22.3 % ) , chair rise ( 26.8 % ) , stair climbing ( 10.4 % ) , 400-m walk ( 7.4 % ) , and balance ( 7.8 % ) . Muscle thickness increased ( P < 0.05 ) by 15.7 % at the quadriceps site . Whole-body lean mass was preserved with no change in fat mass . There were no significant changes in PSA , testosterone , GH , cortisol , or hemoglobin . CONCLUSIONS Progressive resistance exercise has beneficial effects on muscle strength , functional performance and balance in older men receiving and rogen deprivation for prostate cancer and should be considered to preserve body composition and reduce treatment side effects OBJECTIVE To show fatigue prevention and quality of life ( QOL ) improvement from cardiovascular exercise during radiotherapy . DESIGN Prospect i ve enrollment ( n=21 ) , r and omized to exercise ( n=11 ) and control groups ( n=10 ) , with pre- and post-radiotherapy between- and within-group comparisons . SETTING Academic medical center . PARTICIPANTS Localized prostate cancer patients undergoing radiotherapy . INTERVENTIONS The interventional group received radiotherapy plus aerobic exercise 3 times a week for 8 weeks whereas the control group received radiotherapy without exercise . MAIN OUTCOME MEASURES Pre- and post-radiotherapy differences in cardiac fitness , fatigue , depression , functional status , physical , social , and functional well-being , leg strength , and flexibility were examined within and between 2 groups . RESULTS No significant differences existed between 2 groups at pre-radiotherapy assessment . At post-radiotherapy assessment , the exercise group showed significant within group improvements in : cardiac fitness ( P<.001 ) , fatigue ( P=.02 ) , Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) ( P=.04 ) , physical well-being ( P=.002 ) , social well-being ( P=.02 ) , flexibility ( P=.006 ) , and leg strength ( P=.000 ) . Within the control group , there was a significant increase in fatigue score ( P=.004 ) and a decline in social well-being ( P<.05 ) at post-radiotherapy assessment . Between-group differences at post-radiotherapy assessment were significant in cardiac fitness ( P=.006 ) , strength ( P=.000 ) , flexibility ( P<.01 ) , fatigue ( P<.001 ) , FACT-P ( P=.006 ) , physical well-being ( P<.001 ) , social well-being ( P=.002 ) , and functional well-being ( P=.04 ) . CONCLUSIONS An 8-week cardiovascular exercise program in patients with localized prostate cancer undergoing radiotherapy improved cardiovascular fitness , flexibility , muscle strength , and overall QOL and prevented fatigue 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
Output:
| Exercise training demonstrated benefits in muscular strength , cardiorespiratory fitness , functional task performance , lean body mass , and fatigue , with inconsistent effects observed for adiposity .
Among patients with prostate cancer treated with and rogen-deprivation therapy , appropriately prescribed exercise is safe and may ameliorate a range of treatment-induced adverse effects . |
MS210991 | ***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 Flexibility , Toning , and Balance ( FlexToBa ) Trial is a two-armed r and omized controlled trial which will contrast the effects of a DVD-delivered , home-based , physical activity intervention and a Healthy Aging attention control condition on physical activity , functional performance , functional limitations , and quality of life in low active , older adults . This innovative trial will recruit 300 participants across central Illinois who will be r and omized into the intervention arm or control arm of the study . The intervention will last 6 months with a 6 month follow-up . Assessment s at baseline , post intervention and follow-up will include physical activity ( self-report and accelerometry ) , a battery of functional performance measures , functional limitations , quality of life , and an array of psychological health measures . In addition , measures of external validity will be included to determine public health significance of a successful outcome . Participants will engage in a progressive series of activities focusing on flexibility , strengthening , and balance exercises which are demonstrated by a trained exercise leader and age-appropriate models on a series of DVDs . Delivery of the intervention has its basis in social cognitive theory . The specific aims of the trial are ( a ) to determine the effects of the DVD-delivered FlexToBa program on physical activity , functional performance , functional limitations , and quality of life , ( b ) to examine the mediators of the relationships between physical activity and functional limitations and quality of life , ( c ) to assess external validity indicators relative to the intervention , and ( d ) to determine differential effects of the intervention on psychosocial health measures How should health care professionals choose among the many therapies cl aim ed to be efficacious for treating specific disorders ? The practice of evidence -based medicine provides an answer . Advocates of this approach urge health care professionals to base treatment choices on the best evidence from systematic research on both the efficacy and adverse effects of various therapeutic alternatives . Ideally , health care professionals would compare different treatments by referring to r and omized , double-blind , head-to-head trials that compared the treatment options . Although individual medications are typically well research ed when these placebo-controlled studies are performed , studies that directly compare treatments are rare . In the absence of direct head-to-head trials , other evidence comes from indirect comparisons of two or more therapies by examining individual studies involving each treatment . This article provides an introductory review of methods of such indirect comparisons of therapies across studies , provides examples of how these methods can be used to make treatment decisions , and presents a general overview of relevant issues and statistics for readers interested in underst and ing these methods more thoroughly Obesity , metabolic syndrome , dyslipidemia , and poor quality of life are common conditions associated with hypertension , and incidence of hypertension is age dependent . However , an effective program to prevent hypertension and to improve biomedical factors and quality of life has not been adequately examined or evaluated in Chinese older adults . This study aims to examine the effectiveness of a Tai Chi program to improve health status in participants with hypertension and its related risk factors such as dyslipidemia , hyperglycemia , and quality of life in older adults in China . A r and omized study design was used . At the conclusion of the intervention , 266 patients remained in the study . Blood pressure and biomedical factors were measured according to the World Diabetes Association st and ard 2002 . A st and ardized quality -of-life measure was used to measure health-related quality of life . It was found that a Tai Chi program to improve hypertension in older adults is effective in reducing blood pressure and body mass index , maintaining normal renal function , and improving physical health of health-related quality of life . It did not improve existing metabolic syndrome levels , lipid level ( dyslipidemia ) or fasting glucose level ( hyperglycemia ) , to prevent further deterioration of the biomedical risk factors . In conclusion , Tai Chi is effective in managing a number of risk factors associated with hypertension in Chinese older adults . Future research should examine a combination of Tai Chi and nutritional intervention to further reduce the level of biomedical risks In this study , 126 patients ( 90 males , average age 56 years , range 39 - 80 ) were r and omised to Wu Chian-Ch'uan style Tai Chi ( 38 ) , aerobic exercise ( 41 ) or a non-exercise support group ( 47 ) following acute myocardial infa rct ion . Patients attended twice weekly for three weeks then weekly for a further five weeks . Heart rate and blood pressure were recorded before and after each session . Over the 11 sessions of exercise there was a negative trend in diastolic blood pressure only in the Tai Chi group ( Rs = 0.79 , p < 0.01 ) . Significant trends in systolic blood pressure occurred in both exercise groups ( Rs = 0.64 and 0.63 , both p < 0.05 ) . Only four ( 8 % ) patients completed the support group eight-week programme which was less than the number completing Tai Chi ( 82 % ; p < 0.001 ) and aerobic exercise groups ( 73 % ; p < 0.001 ) PURPOSE This study prospect ively evaluated the training effect of a 1-yr Tai Chi Chuan ( TCC ) program for low-risk patients with coronary artery bypass surgery ( CABS ) after a postoperative outpatient ( phase II ) cardiac rehabilitation program . METHODS Twenty patients with mean age of 56.5+/-7.4 yr completed this study . The TCC group included nine men who practice d classical Yang TCC with an exercise intensity of 48 - 57 % heart rate range ( HRR ) . The control group included 11 men whom were recommended to do a home-based self-adjusted exercise program with similar intensity of phase II cardiac rehabilitation . Grade d exercise tests were performed before and after 1 yr of training for all subjects . RESULTS Mean attendance of the TCC group was 3.8+/-1.5 times weekly in contrast to 1.7+/-1.1 times for the control group . During the follow-up examination , the TCC group increased 10.3 % in VO2peak ( from 26.2+/-4.4 to 28.9+/-5.0 mL x kg(-1 ) min(-1 ) , P<0.01 ) and increased 11.9 % in peak work rate ( from 135+/-26 W to 151+/-28 W , P<0.01 ) . However , the control group showed slight decrease in VO2peak from 26.0+/-3.9 to 25.6+/-4.6 mL x kg(-1 ) x min(-1 ) and in peak work rate from 131+/-23 W to 128+/-32 W. At the ventilatory threshold , the TCC group also showed significant increase in VO2 and work rate ( P<0.05 ) . The control group did not significantly change in these variables . CONCLUSIONS The study demonstrated that a 1-yr TCC program for low-risk patients with CABS could favorably enhance cardiorespiratory function BACKGROUND Patients with chronic heart failure ( HF ) and with elevated depression symptoms are at greater risk of morbidity and mortality . Somatic symptoms of depression are particularly prevalent in HF and are related to worse disease prognosis . T'ai chi practice is related to increased emotional well-being in various clinical population s ; however , relatively little is known about t'ai chi 's effects on somatic versus cognitive symptom dimensions of depression in HF . PURPOSE The objective of the study was to measure whether a t'ai chi intervention effectively reduces somatic and /or cognitive symptoms of depression in patients with HF . METHODS Patients with HF were assigned to either t'ai chi training ( n=16 ) or a usual-care group ( n=12 ) . At baseline and after the 12-week intervention period , participants were evaluated for changes in depressive symptoms using Beck Depression Inventory ( BDI ) total scores ( BDI-t ) and subcategorized scores of BDI-somatic ( BDI-s ) and BDI-cognitive ( BDI-c ) , and for symptoms of fatigue using the Multidimensional Fatigue Symptom Inventory-Short Form . RESULTS Patients with HF in the t'ai chi group compared to the usual-care group had reduced BDI-s ( p≤0.017 ) , but not BDI-c ( p=0.50 ) scores from pre- to postintervention . Although t'ai chi did not significantly reduce fatigue , changes in physical fatigue ( p≤0.05 ) were independently associated with changes in BDI-t scores . CONCLUSIONS T'ai chi practice reduced somatic symptoms of depression , which have been linked to worse prognosis in HF . Reductions in fatigue appear to explain some but not all of the reductions in somatic symptoms of depression OBJECTIVES To evaluate the effects on blood pressure , lipid profile , and anxiety status on subjects received a 12-week Tai Chi Chuan exercise program . DESIGN R and omized controlled study of a Tai Chi Chuan group and a group of sedentary life controls . SETTING Taipei Medical University Hospitals and University campus in the Taipei , Taiwan , area . SUBJECTS Two ( 2 ) selected groups of 76 healthy subjects with blood pressure at high-normal or stage I hypertension . INTERVENTION A 12-week Tai Chi Chuan exercise training program was practice d regularly with a frequency of 3 times per week . Each session included 10-minute warm-up , 30-minute Tai Chi exercise , 10-minute cool-down . Exercise intensity was estimated to be approximately 64 % of maximal heart rate . OUTCOME MEASURES Blood pressure , lipid profile and anxiety status ( State-Trait Anxiety Inventory ; STAI ) were evaluated . RESULTS After 12-weeks of Tai Chi training , the treatment group showed significant decrease in systolic blood pressure of 15.6 mm Hg and diastolic blood pressure 8.8 mm Hg . The serum total cholesterol level decreased 15.2 mg/dL and high-density lipoprotein cholesterol increased 4.7 mg/dL. By using STAI evaluation , both trait anxiety and state anxiety were decreased . CONCLUSIONS This study shows that under well- design ed conditions , Tai Chi exercise training could decrease blood pressure and results in favorable lipid profile changes and improve subjects ' anxiety status . Therefore , Tai Chi could be used as an alternative modality in treating patients with mild hypertension , with a promising economic effect Although exercise is an important component of heart failure management , optimal regimens , particularly in heart failure with preserved ejection fraction ( HFPEF ) , are uncertain . Tai chi ( TC ) is a mind-body exercise that may have potential benefits but has not been studied in this population . The authors r and omized 16 patients with HFPEF to either 12 weeks TC or aerobic exercise . Assessment s included peak oxygen uptake , 6-minute walk , quality of life , echocardiography , mood , and self-efficacy at baseline and at 12 weeks . Cardiorespiratory measures during exercise were obtained to characterize training intensities . Baseline characteristics were as follows : age 66±12 years , E/A ratio 1.3±0.7 , and E/e ' ratio 15.9±4.8 . Overall , adherence was excellent ( 89 % attendance ) . Change in peak oxygen uptake was similar between groups after 12 weeks , but 6-minute walk distance increased more after TC ( 69±46 m vs 10±31 m , P=.02 ) . While both groups had improved Minnesota Living With Heart Failure scores and self-efficacy , Profile of Mood States (POMS)-Depression scores improved more with TC ( -1.7±2.8 vs 1.6±3 , P=.05 ) . Cardiorespiratory assessment during TC showed lower oxygen uptake ( 4.3 mL/kg/min vs 9.4 mL/kg/min , P<.01 ) , respiratory rate , and heart rate . TC is feasible and safe in HFPEF . Therepeutic endpoints appear similar with TC relative to aerobic exercise despite a lower aerobic training workload BACKGROUND Patients with a recent myocardial infa rct ion ( MI ) present a reduction in functional capacity expressed as a decrease in peak oxygen consumption ( Vo2 peak ) . The impact of a Tai Chi Chuan ( TCC ) cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed . Our goal is to evaluate functional capacity after a TCC-based cardiac rehabilitation program in patients with recent MI . METHODS A single-blind r and omized clinical trial was conducted . The research ers who performed the tests were blinded to group allocation . Between the 14th and 21st days after hospital discharge , all patients performed a cardiopulmonary exercise testing and a laboratory blood workup . Mean age was similar ( 56±9 years in the TCC group and 60±9 years in the control group ) . Patients allocated to the intervention group performed 3 weekly sessions of TCC Beijin style for 12 weeks ( n=31 ) . The control group participated in 3 weekly sessions of full-body stretching exercises ( n=30 ) . RESULTS After the 12-week study period , participants in the TCC group experienced a significant 14 % increase in Vo2 peak from baseline ( 21.6 ± 5.2 to 24.6 ± 5.2 mL/kg per minute ) , whereas control participants had a nonsignificant 5 % decline in Vo2 peak ( 20.4 ± 5.1 to 19.4 ± 4.4 mL/kg per minute ) . There was a significant difference between the 2 groups ( P<.0001 ) . CONCLUSIONS Tai Chi Chuan practice was associated with an increase in Vo2 peak in patients with a recent MI and may constitute an effective form of cardiac rehabilitation in this patient population Background : Cardiac rehabilitation improves physical , cognitive and
Output:
| Conclusion : Significant effects of Tai Chi have been found in improving aerobic endurance and psychosocial well-being among coronary heart disease patients .
Tai Chi could be a cost-effective and safe exercise option in cardiac rehabilitation . |
MS210992 | ***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 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 Mixed treatment comparison ( MTC ) meta- analysis is a generalization of st and ard pairwise meta- analysis for A vs B trials , to data structures that include , for example , A vs B , B vs C , and A vs C trials . There are two roles for MTC : one is to strengthen inference concerning the relative efficacy of two treatments , by including both ' direct ' and ' indirect ' comparisons . The other is to facilitate simultaneous inference regarding all treatments , in order for example to select the best treatment . In this paper , we present a range of Bayesian hierarchical models using the Markov chain Monte Carlo software WinBUGS . These are multivariate r and om effects models that allow for variation in true treatment effects across trials . We consider models where the between-trials variance is homogeneous across treatment comparisons as well as heterogeneous variance models . We also compare models with fixed ( unconstrained ) baseline study effects with models with r and om baselines drawn from a common distribution . These models are applied to an illustrative data set and posterior parameter distributions are compared . We discuss model critique and model selection , illustrating the role of Bayesian deviance analysis , and node-based model criticism . The assumptions underlying the MTC models and their parameterization are also discussed Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists Assessing the quality of r and omized controlled trials ( RCTs ) is important and relatively new . Quality gives us an estimate of the likelihood that the results are a valid estimate of the truth . We present an annotated bibliography of scales and checklists developed to assess quality . Twenty-five scales and nine checklists have been developed to assess quality . The checklists are most useful in providing investigators with guidelines as to what information should be included in reporting RCTs . The scales give readers a quantitative index of the likelihood that the reported methodology and results are free of bias . There are several shortcomings with these scales . Future scale development is likely to be most beneficial if questions common to all trials are assessed , if the scale is easy to use , and if it is developed with sufficient rigor This study aims to compare h and search ing to a basic MEDLINE search for the identification of reports of r and omized trials in specialized health care journals . Twenty-two specialized health care journals , published in the U.K. , were h and search ed for all reports of controlled trials ( as defined by the Cochrane Collaboration ) . The reports of trials , which were judged to be definitely r and omized , were identified from a r and om sample of three years per journal and form one element of this study . A MEDLINE search using the publication type terms ' r and omized controlled trial ' and ' controlled clinical trial ' was also performed for the same journal years . The reports of trials retrieved by h and search ing were then compared against those retrieved from the MEDLINE search , to identify differences in retrieval between the two techniques . Reports of r and omized trials identified by the MEDLINE search but not found by h and search ing were individually assessed to see if they met the Cochrane eligibility criteria for a report of a r and omized trial . A total of 714 reports of r and omized trials were found by using a combination of both h and search ing and MEDLINE search ing . Of these , 369 ( 52 per cent ) were identified only by h and search ing and 32 ( 4 per cent ) were identified only by MEDLINE search ing . Of the reports identified only by h and search ing , 252 had no MEDLINE record , of which 232 ( 92 per cent ) were meeting abstract s or published in supplements ; 117 ( 25 per cent ) of the 462 reports of r and omized trials which had a MEDLINE record were missed by the electronic search because they did not have either of the publication type terms ' r and omized controlled trial ' or ' controlled clinical trial ' . This proportion varied depending on when the reports of r and omized trials were published ( that is , before or after the introduction of the MEDLINE publication type terms above ) . The highest additional yield from h and search ing compared to MEDLINE search ing was for reports of r and omized trials published prior to 1991 and from h and search ing the non- MEDLINE indexed parts of a journal . The results of this study suggest that a combination of MEDLINE and h and search ing is required to identify adequately reports of r and omized trials In a retrospective survey , 487 research projects approved by the Central Oxford Research Ethics Committee between 1984 and 1987 , were studied for evidence of publication bias . As of May , 1990 , 285 of the studies had been analysed by the investigators , and 52 % of these had been published . Studies with statistically significant results were more likely to be published than those finding no difference between the study groups ( adjusted odds ratio [ OR ] 2.32 ; 95 % confidence interval [ Cl ] 1.25 - 4.28 ) . Studies with significant results were also more likely to lead to a greater number of publications and presentations and to be published in journals with a high citation impact factor . An increased likelihood of publication was also associated with a high rating by the investigator of the importance of the study results , and with increasing sample size . The tendency towards publication bias was greater with observational and laboratory-based experimental studies ( OR = 3.79 ; 95 % Cl = 1.47 - 9.76 ) than with r and omised clinical trials ( OR = 0.84 ; 95 % Cl = 0.34 - 2.09 ) . We have confirmed the presence of publication bias in a cohort of clinical research studies . These findings suggest that conclusions based only on a review of published data should be interpreted cautiously , especially for observational studies . Improved strategies are needed to identify the results of unpublished as well as published studies Dr. Joseph Lau is a world-leading expert in meta- analysis and systematic review s. Currently a professor in the Department of Health Services , Policy and Practice and co-director of the Center for Evidence -based Medicine at Brown University , Professor Lau has applied evidence -based methods to a variety of clinical , biomedical and healthcare topics ; has developed reliable and efficient methods and tools to conduct systematic review s and meta-analyses ; and has advanced an underst and ing on the impact of factors that may contribute to differences of results in scientific studies . His past research includes cumulative meta- analysis of r and omized controlled trials , comparison of results from large trials and meta-analyses of small trials , effect of baseline risk in the interpretation of clinical trial results , and empirical evaluation of existing methods of combining data . His current focus is on a Web-based repository of systematic review data , review s of diagnostic tests , nutrition , clinical practice guidelines , and dissemination of evidence -based methods to varied health-care disciplines . This report is a conversation from an adapted version of an interview , more or less chronologically arranged , between Joseph C. Cappelleri as interviewer and Joseph Lau as interviewee , with Meghan Ingerick recording and transcribing the interview Abstract An increased mortality in early breast cancer can be correlated to the routine use of local postoperative irradiation . The decreased survival is statistically significant . Of controlled clinical trials so far published , all six , including more than 3400 patients , demonstrate decreased survival of between 1 and 10 % in irradiated patients when compared with those treated by mastectomy alone
Output:
| The article ends by explaining how Simonton 's chance configuration theory and Campbell 's evolutionary epistemology can illuminate why meta- analysis occurred with these scholars when it did and not in medical sciences |
MS210993 | ***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 Both the epidermal growth factor receptor and vascular endothelial growth factor pathways are frequently overexpressed in glioblastoma multiforme . This study combined bevacizumab , a vascular endothelial growth factor inhibitor , and erlotinib , an epidermal growth factor receptor inhibitor , with st and ard radiation and temozolomide ( TMZ ) , with the goal of improving overall survival ( OS ) . METHODS Treatment consisted of fractionated radiotherapy to 60 Gy , with daily TMZ at 75 mg/m²/d and erlotinib 150 - 200 mg/d ( or 500 - 600 mg/d for patients on enzyme-inducing antiepileptic drugs ) . Bevacizumab was given at 10 mg/kg every 2 weeks , starting ≥4 weeks after surgery . After radiotherapy , adjuvant TMZ was given at 200 mg/m²/d × 5d per 28-day cycle , with unchanged erlotinib and bevacizumab doses . Treatment continued until progression or for 12 months . Efficacy was compared against an institutional historical control . A sample of 55 patients was calculated to provide 85 % power to detect a hazard ratio of 0.67 for OS . RESULTS Fifty-nine patients were enrolled for efficacy analysis after a 15-patient safety lead-in . For the efficacy group , median age was 54 years ; median KPS was 90 . Gross total and subtotal resections were achieved in 33 % and 53 % , respectively . The most frequent related grade 3/4 adverse effects were lymphopenia , thrombocytopenia , neutropenia , diarrhea , weight loss , and fatigue . One patient died of disseminated aspergillosis . Median OS was 19.8 months ( vs 18 mo for HC , P = .33 ) and median progression-free survival was 13.5 months ( vs 8.6 mo for HC , P = .03 ) . CONCLUSIONS The combination of bevacizumab , erlotinib , TMZ , and radiotherapy appears to be well tolerated and improved progression-free survival but did not reach the primary endpoint of improved OS BACKGROUND Concurrent treatment with temozolomide and radiotherapy followed by maintenance temozolomide is the st and ard of care for patients with newly diagnosed glioblastoma . Bevacizumab , a humanized monoclonal antibody against vascular endothelial growth factor A , is currently approved for recurrent glioblastoma . Whether the addition of bevacizumab would improve survival among patients with newly diagnosed glioblastoma is not known . METHODS In this r and omized , double-blind , placebo-controlled trial , we treated adults who had central ly confirmed glioblastoma with radiotherapy ( 60 Gy ) and daily temozolomide . Treatment with bevacizumab or placebo began during week 4 of radiotherapy and was continued for up to 12 cycles of maintenance chemotherapy . At disease progression , the assigned treatment was revealed , and bevacizumab therapy could be initiated or continued . The trial was design ed to detect a 25 % reduction in the risk of death and a 30 % reduction in the risk of progression or death , the two co primary end points , with the addition of bevacizumab . RESULTS A total of 978 patients were registered , and 637 underwent r and omization . There was no significant difference in the duration of overall survival between the bevacizumab group and the placebo group ( median , 15.7 and 16.1 months , respectively ; hazard ratio for death in the bevacizumab group , 1.13 ) . Progression-free survival was longer in the bevacizumab group ( 10.7 months vs. 7.3 months ; hazard ratio for progression or death , 0.79 ) . There were modest increases in rates of hypertension , thromboembolic events , intestinal perforation , and neutropenia in the bevacizumab group . Over time , an increased symptom burden , a worse quality of life , and a decline in neurocognitive function were more frequent in the bevacizumab group . CONCLUSIONS First-line use of bevacizumab did not improve overall survival in patients with newly diagnosed glioblastoma . Progression-free survival was prolonged but did not reach the prespecified improvement target . ( Funded by the National Cancer Institute ; Clinical Trials.gov number , NCT00884741 . ) BACKGROUND Prognosis of unresectable glioblastoma ( GB ) remains poor , despite temozolomide (TMZ)-based chemoradiation . Activity of bevacizumab ( BEV ) and irinotecan ( IRI ) has been reported in recurrent disease . We evaluated BEV and IRI as neo-adjuvant and adjuvant treatment combined with TMZ-based chemoradiation for unresectable GB . PATIENTS AND METHODS Patients with unresectable GB , age 18 - 70 , IK ≥50 were eligible . The experimental arm ( BEV/IRI ) consisted of neo-adjuvant intravenous BEV , 10 mg/kg , and IRI , 125 mg/m(2 ) , every 2 weeks for four cycles before radiotherapy ( RT ) ( 60 Gy ) , concomitant oral TMZ , 75 mg/m(2)/day , and BEV , 10 mg/kg every 2 weeks . Adjuvant BEV and IRI were given every 2 weeks for 6 months . The control arm consisted of concomitant oral TMZ , 75 mg/m(2)/day during RT , and 150 - 200 mg/m(2 ) for 5 days every 28 days for 6 months . The use of BEV was allowed at progression in the control arm . RESULTS Patients ( 120 ) were included from April 2009 to January 2011 . The working hypothesis was that treatment would increase the progression-free survival at 6 month ( PFS-6 ) from 50 % to 66 % . The primary objective was not achieved , and only 30 out of 60 patients were alive without progression at 6 months ( 50.0 % [ IC95 % ( 36.8 ; 63.1 ) ] in the BEV/IRI arm when 37 out of 60 patients were required according to the Fleming decision rules . PFS-6 was 7.1 months in BEV/IRI versus 5.2 months in the control arm . The median overall survival was not different between the two arms ( 11.1 months ) . Main toxicities were three fatal intracranial bleedings , three bile duct or digestive perforations/infections ( 1 fatal ) , and six thrombotic episodes in the BEV/IRI arm , whereas there was one intracranial bleeding , two bile duct or digestive perforations/infections ( 1 fatal ) , and one thrombotic episode in the control arm . CONCLUSIONS Neo-adjuvant and adjuvant BEV/IRI , combined with TMZ-radiation , is not recommended for further evaluation in the first-line treatment of unresectable GB . CLINICAL TRIAL REGISTRATION Clinical trial registered under EUDRACT number 2008 - 002775 - 28 ( NCT01022918 ) BACKGROUND High- grade gliomas ( HGGs ) are among the most prothrombotic of malignancies . METHODS We performed a prospect i ve study to investigate 11 potential biomarkers for prediction of venous thromboembolism ( VTE ) in newly diagnosed HGG patients who had undergone a neurosurgical intervention . In addition , we tested 2 VTE risk assessment models ( RAMs ) . The strongest predictors of VTE , which were identified by statistical forward selection , were used for the first RAM . The parameters used for the second RAM were both predictive of VTE and available in routine clinical practice . RESULTS One hundred forty-one HGG patients were included in this study , and 24 ( 17 % ) of them developed VTE during follow-up . An association with the risk of future VTE was found for the following parameters : leukocyte count , platelet count , sP-selectin , prothrombin-fragment 1 + 2 , FVIII activity , and D-dimer . The first RAM included low platelet count ( < 25th percentile of the study population ) and elevated sP-selectin ( ≥75th percentile ) . The cumulative VTE probability after 12 months was 9.7 % for score 0 ( n = 76 ) , 18.9 % for score 1 ( n = 59 ) , and 83.3 % for score 2 ( n = 6 ) . The second RAM included low platelet count ( < 25th percentile ) , elevated leukocyte count , and elevated D-dimer ( ≥75th percentile ) . The probability of VTE was 3.3 % for score 0 ( n = 63 ) , 23.0 % for score 1 ( n = 53 ) , and 37.7 % for score 2 ( n = 22 ) or score 3 ( n = 3 ) . CONCLUSIONS We identified biomarkers suitable for assessing the VTE risk in newly diagnosed HGG patients . The application of 2 RAMs allowed identification of patients at high risk of developing VTE . We could also define patients at low risk of VTE , who would most probably not benefit from extended primary thromboprophylaxis PURPOSE To determine the safety of the addition of bevacizumab to st and ard radiation therapy and daily temozolomide for newly diagnosed glioblastoma multiforme ( GBM ) . METHODS AND MATERIAL S A total of 125 patients with newly diagnosed GBM were enrolled in the study , and received st and ard radiation therapy and daily temozolomide . All patients underwent a craniotomy and were at least 2 weeks postoperative . Radiation therapy was administered in 1.8-Gy fractions , with the clinical target volume for the primary course treated to a dose of 45 to 50.4 Gy , followed by a boost of 9 to 14.4 Gy , to a total dose of 59.4 Gy . Patients received temozolomide at 75 mg/m(2 ) daily throughout the course of radiation therapy . Bevacizumab was given at 10 mg/kg intravenously every 14 days , beginning a minimum of 4 weeks postoperatively . RESULTS Of the 125 patients , 120 ( 96 % ) completed the protocol -specified radiation therapy . Five patients had to stop the protocol therapy , 2 patients with pulmonary emboli , and 1 patient each with a Grade 2 central nervous system hemorrhage , Grade 4 pancytopenia , and wound dehiscence requiring surgical intervention . All 5 patients ultimately finished the radiation therapy . After radiation therapy , 3 patients had progressive disease , 2 had severe fatigue and decreased performance status , 1 patient had a colonic perforation , and 1 had a rectal fissure ; these 7 patients therefore did not proceed with the protocol -specified adjuvant temozolomide , bevacizumab , and irinotecan . However , 113 patients ( 90 % ) were able to continue on study . CONCLUSIONS The addition of bevacizumab to st and ard radiation therapy and daily temozolomide was found to be associated with minimal toxicity in patients newly diagnosed with GBM PURPOSE Venous thromboembolism ( VTE ) is a well-recognized complication of cancer . Laboratory parameters might be useful to assess the VTE risk in patients with cancer . The aim of this study was to investigate D-dimer and prothrombin fragment 1 + 2 ( F 1 + 2 ) , which reflect activation of blood coagulation and fibrinolysis , for prediction of cancer-associated VTE . PATIENTS AND METHODS In a prospect i ve , observational , cohort study of 821 patients with newly diagnosed cancer or progression of disease who did not recently receive chemotherapy , radiotherapy , or surgery were enrolled and followed for a median of 501 days ( interquartile range , 255 to 731 days ) . The malignancies in these patients were as follows : breast ( n = 132 ) , lung ( n = 119 ) , stomach ( n = 35 ) , lower gastrointestinal tract ( n = 106 ) , pancreas ( n = 46 ) , kidney ( n = 22 ) , and prostate ( n = 101 ) cancers ; high- grade glioma ( n = 102 ) ; malignant lymphoma ( n = 94 ) ; multiple myeloma ( n = 17 ) ; and other tumor types ( n = 47 ) . The study end point was occurrence of objective ly confirmed symptomatic or fatal VTE . RESULTS VTE occurred in 62 patients ( 7.6 % ) . The cutoff level for elevated D-dimer and elevated F 1 + 2 was set at the 75th percentile of the total study population . In multivariable analysis that included elevated D-dimer , elevated F 1 + 2 , age , sex , surgery , chemotherapy , and radiotherapy , the hazard ratios ( HRs ) of VTE in patients with elevated D-dimer ( HR , 1.8 ; 95 % CI , 1.0 to 3.2 ; P = .048 ) and elevated F 1 + 2 ( HR , 2.0
Output:
| As there was a trend toward significance with regard to bevacizumab therapy and the risk of pulmonary embolism , anticoagulation may be advisable in certain newly diagnosed adult GBM patients who display a history of thromboembolism and /or more serious risk factors for thromboembolic events |
MS210994 | ***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 assess the efficacy of endovascular aneurysm repair ( EVAR ) against st and ard alternative management in patients with large abdominal aortic aneurysm ( AAA ) . DESIGN Two national , multicentre r and omised trials - EVAR trials 1 and 2 . SETTING Patients were recruited from 38 out of 41 eligible UK hospitals . PARTICIPANTS Men and women aged at least 60 years , with an AAA measuring at least 5.5 cm on a computerised tomography scan that was regarded as anatomically suitable for EVAR , were assessed for fitness for open repair . Patients considered fit were r and omised to EVAR or open repair in EVAR trial 1 and patients considered unfit were r and omised to EVAR or no intervention in EVAR trial 2 . INTERVENTIONS EVAR , open repair or no intervention . MAIN OUTCOME MEASURES The primary outcome was mortality ( operative , all-cause and AAA related ) . Patients were flagged at the UK Office for National Statistics with central ly coded death certificates assessed by an Endpoints Committee . Power calculations based upon mortality indicated that 900 and 280 patients were required for EVAR trials 1 and 2 , respectively . Secondary outcomes were graft-related complications and re interventions , adverse events , renal function , health-related quality of life and costs . Cost-effectiveness analyses were performed for both trials . RESULTS Recruitment occurred between 1 September 1999 and 31 August 2004 , with targets exceeded in both trials : 1252 r and omised into EVAR trial 1 ( 626 to EVAR ) and 404 r and omised into EVAR trial 2 ( 197 to EVAR ) . Follow-up closed in December 2009 with very little loss to follow-up ( 1 % ) . In EVAR trial 1 , 30-day operative mortalities were 1.8 % and 4.3 % in the EVAR and open-repair groups , respectively : adjusted odds ratio 0.39 [ 95 % confidence interval ( CI ) 0.18 to 0.87 ] , p = 0.02 . During a total of 6904 person-years of follow-up , 524 deaths occurred ( 76 AAA related ) . Overall , there was no significant difference between the groups in terms of all-cause mortality : adjusted hazard ratio ( HR ) 1.03 ( 95 % CI 0.86 to 1.23 ) , p = 0.72 . The EVAR group did demonstrate an early advantage in terms of AAA-related mortality , which was sustained for the first few years , but lost by the end of the study , primarily due to fatal endograft ruptures : adjusted HR 0.92 ( 95 % CI 0.57 to 1.49 ) , p = 0.73 . The EVAR procedure was more expensive than open repair ( mean difference £ 1177 ) and not found to be cost-effective , but the model was sensitive to alternative assumptions . In EVAR trial 2 , during a total of 1413 person-years of follow-up , a total of 305 deaths occurred ( 78 AAA related ) . The 30-day operative mortality was 7.3 % in the EVAR group . However , this group later demonstrated a significant advantage in terms of AAA-related mortality , but this became apparent only after 4 years : overall adjusted HR 0.53 ( 95 % CI 0.32 to 0.89 ) , p = 0.02 . Sadly , this advantage did not result in any benefit in terms of all-cause mortality : adjusted HR 0.99 ( 95 % CI 0.78 to 1.27 ) , p = 0.97 . Overall , EVAR was more expensive than no intervention ( mean difference £ 10,222 ) and not found to be cost-effective . CONCLUSIONS EVAR offers a clear operative mortality benefit over open repair in patients fit for both procedures , but this early benefit is not translated into a long-term survival advantage . Among patients unfit for open repair , EVAR is associated with a significant long-term reduction in AAA-related mortality but this does not appear to influence all-cause mortality . TRIAL REGISTRATION Current Controlled Trials IS RCT N 55703451 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 16 , No. 9 . See the HTA programme website for further project information BACKGROUND The Positive Impact of EndoVascular Options for Treating Aneurysms Early ( PIVOTAL ) trial enrolled individuals with small ( 4.0- to 5.0-cm diameter ) abdominal aortic aneurysms ( AAA ) and reported no difference in rupture or aneurysm-related death for patients who received early endovascular repair ( EVAR ) vs surveillance with serial imaging studies . We evaluated re source use , medical cost , and quality of life outcomes associated with the PIVOTAL treatment strategies . METHODS This prospect i ve economic and quality of life study was conducted within a r and omized trial , with PIVOTAL sites participating in the quality of life ( n = 67 ) and economic ( n = 63 ) studies . The PIVOTAL trial r and omized 728 patients ( 366 early EVAR and 362 surveillance ) . We used information from 701 quality of life ( 351 early EVAR and 350 surveillance ) and 614 economic ( 314 early EVAR and 300 surveillance ) study participants enrolled in the PIVOTAL trial . The main outcome measures were total medical costs and the aneurysm repair rate at 48 months . RESULTS After 6 months , the rate of aneurysm repair was 96 vs 10 per 100 patients in the early EVAR and surveillance groups , respectively ( difference , 86 ; 95 % confidence interval [ CI ] , 82 - 90 ; P < .0001 ) , and total medical costs were greater in the early EVAR group ( $ 33,471 vs $ 5520 ; difference , $ 27,951 ; 95 % CI , $ 25,156-$30,746 ; P < .0001 ) . In months 7 through 48 , however , the rate of aneurysm repair was 54 per 100 patients in the surveillance group , and total medical costs were higher for patients in the surveillance vs the early EVAR group ( $ 40,592 vs $ 15,197 ; difference , $ 25,394 ; 95 % CI , $ 15,184-$35,605 ; P < .0001 ) . At 48 months ' follow-up , early EVAR patients had greater cumulative use of AAA repair ( 97 vs 64 per 100 patients ; difference , 34 ; 95 % CI , 21 - 46 ; P < .0001 ) , but there was no difference in total medical costs ( $ 48,669 vs $ 46,112 ; difference , $ 2557 ; 95 % CI , -$8043 to $ 13,156 ; P = .64 ) . After discounting at 3 % per annum , total medical costs for early EVAR and surveillance patients remained similar ( $ 47,765 vs $ 43,532 ; difference , 4232 ; 95 % CI , -$5561 to $ 14,025 ; P = .40 ) . There were no treatment-related differences in quality of life at 24 months . CONCLUSIONS A treatment strategy involving early repair of smaller AAA with EVAR is associated with no difference in total medical costs at 48 months vs surveillance with serial imaging studies . Longer follow-up is required to determine whether the late medical cost increases observed for surveillance will persist beyond 48 months OBJECTIVE This study was conducted to determine the costs and comparative cost-effectiveness of two methods of abdominal aortic aneurysm ( AAA ) repair in the Open Versus Endovascular Repair ( OVER ) Veterans Affairs ( VA ) Cooperative Study , a multicenter r and omized trial of 881 patients . METHODS The primary outcomes of this analysis were mean total health care cost per life-year and per quality -adjusted life-year ( QALY ) from r and omization to 2 years after . QALYs were calculated from EuroQol (EQ)-5D question naires collected at baseline and annually . Health care utilization data were obtained directly from patients and from national VA and Medicare data sources . VA costs were obtained from national VA sources using methods previously developed by the VA Health Economics Re source Center . Costs for non-VA care were determined from Medicare cl aims data or billing data from the patient 's health care providers . RESULTS After 2 years of follow-up , mean life-years were 1.78 in the endovascular repair group and 1.74 in the open repair group ( difference , 0.04 ; 95 % confidence interval [ CI ] , -0.03 to 0.09 ; P = .29 ) . Mean QALYs were 1.462 in the endovascular group and 1.461 in the open group ( difference adjusting for baseline EQ-5D score , 0.006 ; 95 % CI , -0.038 to 0.052 ; P = .78 ) . Mean graft costs were higher in the endovascular group ( $ 14,052 vs $ 1363 ; P < .001 ) , but length of stay was shorter ( 5.0 vs 10.5 days ; P < .001 ) , result ing in a lower mean cost of the hospital admission for the AAA procedure in the endovascular repair group of $ 37,068 vs $ 42,970 ( difference , -$5901 ; 95 % CI , -$12,135 to -$821 ; P = .04 ) . After 2 years , total health care costs remained lower in the endovascular group , but the difference was no longer significant ( -$5019 ; 95 % CI , -$16,720 to $ 4928 ; P = .35 ) . The probability of endovascular repair being less costly and more effective was 70.9 % for life-years and 51.4 % for QALYs . CONCLUSIONS In this multicenter r and omized trial , endovascular AAA repair result ed in lower cost and better survival than open repair after the initial hospitalization for repair ; but after 2 years , survival , quality of life , and costs were not significantly different between the two treatments Objective To assess the cost effectiveness of screening men aged 65 for abdominal aortic aneurysm . Design Cost effectiveness analysis based on a probabilistic , enhanced economic decision analytical model from screening to death . Population and setting Hypothetical population of men aged 65 invited ( or not invited ) for ultrasound screening in the Danish healthcare system . Data sources Published results from r and omised trials and observational epidemiological studies retrieved from electronic bibliographic data bases , and supplementary data obtained from the Danish Vascular Registry . Data synthesis A hybrid decision tree and Markov model was developed to simulate the short term and long term effects of screening for abdominal aortic aneurysm compared with no systematic screening on clinical and cost effectiveness outcomes . Probabilistic sensitivity analyses using Monte Carlo simulation were carried out . Results were presented in a cost effectiveness acceptability curve , an expected value of perfect information curve , and a curve showing the expected ( net ) number of avoided deaths from abdominal aortic aneurysm over time after the introduction of screening . The model was vali date d by calibrating base case health outcomes and expected activity levels against evidence from the recent Cochrane review of screening for abdominal aortic aneurysm . Results The estimated costs per quality adjusted life year ( QALY ) gained discounted at 3 % per year over a lifetime for costs and QALYs was £ 43 485 ( € 54 852 ; $ 71 160 ) . At a willingness to pay threshold of £ 30 000 the probability of screening for abdominal aortic aneurysm being cost effective was less than 30 % . One way sensitivity analyses showed the incremental cost effectiveness ratio varying from £ 32 640 to £ 66 001 per QALY . Conclusion Screening for abdominal aortic aneurysm does not seem to be cost effective . Further research is needed on long term quality of life outcomes and costs The Glasgow Aneurysm Score ( GAS ) , developed and published by the same authors , is a clinical prognostic scoring system that predicts mortality when operating on either intact or ruptured abdominal aortic aneurysms ( AAA ) taking into account these clinical criteria : patient 's age , shock at presentation , myocardial disease , cerebrovascular disease and renal disease . The GAS was prospect ively evaluated by study ing 320 consecutive patients with AAA who were operated on at Glasgow , Aberdeen and Inverness , Scotl and , in the period between January 1990 and May 1993 . Logistic regression analysis showed very similar results to the original analysis used in developing the score . Age , shock , myocardial disease and renal disease were highly significant . Although it was not significant , cerebrovascular disease weight was not significantly different to its value in the original analysis . The mortality correlated well with the values of the score and ranged from 0 % for scores below ' 70 GAS ' to 80 % for scores over ' 95 GAS ' . The GAS appears , therefore , to be a reliable clinical predicative tool in foretelling the outcome of operating on AAA
Output:
| RESULTS The analysis demonstrated it is feasible to build and run a complex clinical decision aid using DES .
The model results support current guidelines for most vignettes but suggest that earlier repair may be effective in younger , fitter patients and ongoing surveillance may be effective in elderly patients with comorbidities .
The model adds information to support decisions for patients with aneurysms outside current indications .
The economic evaluation suggests that using the ARDA compared with current guidelines could be cost-effective but there is a high level of uncertainty .
LIMITATIONS Lack of high- quality long-term data to populate all sections of the model meant that there is high uncertainty about the long-term clinical and economic consequences of repair .
The ARDA provides detailed information on the potential consequences of AAA repair or a decision not to repair that may be helpful to vascular surgeons and their patients in reaching informed decisions . |
MS210995 | ***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 No long-term impact has yet been observed with the use of the social-influences approach to school-based smoking prevention for youth . However , whether this lack of impact is due to method ologic problems with the studies or to the failure of the interventions is unclear . The Hutchinson Smoking Prevention Project ( HSPP ) , conducted from September 1984 through August 1999 , aim ed to attain the most rigorous r and omized trial possible to determine the long-term impact of a theory-based , social-influences , grade 3 - 12 intervention on smoking prevalence among youth . METHODS Forty Washington school districts were r and omly assigned to the intervention or to the control condition . Study participants were children enrolled in two consecutive 3rd grade s in the 40 districts ( n = 8388 ) ; they were followed to 2 years after high school . The trial achieved high implementation fidelity and 94 % follow-up . Data were analyzed with the use of group-permutation methods , and all statistical tests were two-sided . RESULTS No significant difference in prevalence of daily smoking was found between students in the control and experimental districts , either at grade 12 ( difference [ Delta ] = 0.2 % , 95 % confidence interval [ CI ] = -4.6 % to 4.4 % , and P = .91 for girls ; Delta = 0.3 % , 95 % CI = -5.0 % to 5.5 % , and P = .89 for boys ) or at 2 years after high school ( Delta = -1.4 % , 95 % CI = -5.0 % to 1.6 % , and P = .38 for girls ; Delta = 2.6 % , 95 % CI = -2.5 % to 7.7 % , and P = .30 for boys ) . Moreover , no intervention impact was observed for other smoking outcomes , such as extent of current smoking or cumulative amount smoked , or in subgroups that differ in a priori specified variables , such as family risk for smoking . CONCLUSION The rigor of the HSPP trial suggests high credence for the intervention impact results . Consistent with previous trials , there is no evidence from this trial that a school-based social-influences approach is effective in the long-term deterrence of smoking among youth BACKGROUND Interventions design ed to prevent tobacco and alcohol use targeting high-risk adolescents are limited . In addition , few studies have attempted to improve parent-child communication skills as a way of improving and maintaining healthy youth decision-making . METHODS A total of 660 Hispanic migrant families participated in a r and omized pre-post control group study that was utilized to determine the impact of the intervention on parent-child communication . Both treatment and attention-control groups of youth were exposed to an eight-session culturally sensitive program presented by bilingual/bicultural college students . Parents jointly attended three of the eight sessions and participated in helping their child complete homework assignments supporting the content of each session . The content of the treatment intervention included ( 1 ) information about tobacco and alcohol effects , ( 2 ) social skills training ( i.e. , refusal skills ) , and ( 3 ) the specific development of parent-child communication skills to support healthy youth decisions . RESULTS Significant intervention by household size interactions for both parent and youth perceptions of communication were found indicating that the treatment was effective in increasing communication in families with fewer children . Based on the effect size and the previously established relationship between communication and susceptibility to tobacco and alcohol use , it was determined that the intervention effect could be translated into a future 5 to 10 % decrease in susceptibility for these smaller families . CONCLUSIONS A culturally sensitive family-based intervention for migrant Hispanic youth was found to be effective in increasing perceived parent-child communication in families with fewer children . It is expected that increases in this important protective factor will lead to later observed decreases in tobacco and alcohol use Background Although waterpipe tobacco smoking seems to be increasing on U.S. university campuses , these data have come from convenience sample s. Purpose We aim ed to determine the prevalence of and associations with waterpipe tobacco smoking among a r and om sample of students . Methods We surveyed a r and om sample of graduate and undergraduate students at a large , urban university . We used multivariate modeling to determine independent associations between belief-related predictors and waterpipe tobacco smoking . Results Of the 647 respondents , waterpipe smoking was reported in 40.5 % , over the past year in 30.6 % , and over the past 30 days in 9.5 % . Over half of the sample ( 52.1 % ) perceived that tobacco smoking from a waterpipe was less addictive than cigarette smoking . In fully adjusted multivariate models , 1-year waterpipe smoking was associated with low perceived harm ( OR = 2.54 , 95 % CI = 1.68 , 3.83 ) , low perceived addictiveness ( OR = 4.64 , 95 % CI = 3.03 , 7.10 ) , perception of high social acceptability ( OR = 20.00 , 95 % CI = 6.03 , 66.30 ) , and high perception of popularity ( OR = 4.72 , 95 % CI = 2.85 , 7.82 ) . Conclusions In this sample , lifetime waterpipe use was as common as lifetime cigarette use . Perception of harm , perception of addictiveness , social acceptability , and popularity were all strongly related to waterpipe smoking Sc and inavian moist snuff ( snus ) is cl aim ed to be a safer alternative to smoking . We aim ed to quantify cancer incidence among male snus users and to shed light on the net health outcome by study ing their overall mortality . A cohort , comprised of 9,976 men who participated in a population -based survey , was compiled in 1973 - 74 . Follow-up until January 31 , 2002 , was accomplished through record-linkages with nation-wide and essentially complete registers of demographics , cancer and causes of deaths . Adjusted relative risks among exposed relative to unexposed men were estimated using Cox proportional hazards regression . The cohort members contributed more than 220,000 person-years at risk for cancer . A statistically significant increase in the incidence of the combined category of oral and pharyngeal cancer among daily users of snus ( incidence rate ratio 3.1 , 95 % confidence interval 1.5 - 6.6 ) was found . Overall mortality was also slightly increased ( hazard ratio 1.10 , 95 % confidence interval 1.01 - 1.21 ) . Although the combined previous literature on snus and oral cancer weigh toward no association , this population -based prospect i ve study provided suggestive evidence of snus-related risks that can not be lightly ignored OBJECTIVES This study investigated the efficacy of a social-influences tobacco prevention program conducted with adolescents living in a high tobacco production area . METHODS Students in 10 experimental schools completed the tobacco prevention program and a booster intervention . Control students received health education as usual . RESULTS After 2 years of treatment , smoking rates in the treatment group ( vs the control group ) were lower for 30-day , 7-day , and 24-hour smoking . The intervention had more of an impact on those who were involved in raising tobacco than it did on those not involved in raising tobacco . CONCLUSIONS Although modest , effects were achieved with minimal intervention time in a high-risk group , indicating that social-influences prevention programs may be effective in such groups BACKGROUND This article discusses the development , implementation , and preliminary testing of an intervention to reduce cancer risks through tobacco use prevention and dietary modification among Native American youth in the Northeastern United States . METHODS The intervention outcome study includes a research design and outcome measurement instruments . In collaboration with Native American communities , reservations , and organizations in the Northeastern United States , implementation of the design quantifies the separate and combined effects of a tobacco use prevention and a dietary modification intervention . RESULTS Native American youths in the tobacco prevention intervention and in the combined tobacco and dietary intervention increased their knowledge of tobacco facts and their awareness of the motives of tobacco advertising , and showed higher ratings for an ability to resist peer pressure and to refuse offers of tobacco use between pretest and posttest . Youths in the combined intervention were significantly less apt to report smoking of any kind . Youths in the tobacco use prevention-only condition reported significantly less smoking than their counterparts in the dietary modification-only condition and control condition on 4 of 8 measurement items . As for dietary variables , pretest to posttest measurement scores showed that , after receiving the curriculum , youths in the dietary modification intervention and in the combined intervention improved their knowledge of the health implication s of consuming dietary fat , fiber , fruits , and vegetables . Youths in the dietary modification and combined intervention also improved their scores of knowledge related to cancer risk-reducing nutritional practice s , cultural dietary habits , and healthy food choices available for Native American cultures . Youths in the dietary modification-only condition report significantly increasing their consumption of complex carbohydrates and significantly decreasing their fat intake between pretest and posttest occasions . CONCLUSIONS Data from this longitudinal study suggest the value of the FACETS curriculum for helping Native American youth reduce their risks for cancer associated with tobacco use and dietary preference and consumption patterns . In particular , results indicate the enhanced effects of the combined tobacco use prevention and dietary modification intervention for preventing tobacco use and for improving youths ' knowledge and attitudes with regard to tobacco use and diet . Further , the study demonstrates the value of collaborating with Native American organizations to design a cancer risk-reducing curriculum and to implement tests of that curriculum OBJECTIVES Previous research has suggested that early smoking initiation predicts longer duration of smoking , heavier daily consumption , and increased chances of nicotine dependence . This report set out to estimate the relationship between smoking cessation and age of initiation , as well as nicotine dependence , sex , race , and education . METHODS A sample of 1007 young adults was r and omly selected from a large health maintenance organization in southeast Michigan . Hazard ratios of quitting associated with age at smoking initiation were estimated among 414 persons who smoked daily for 1 month or more . RESULTS With potential confounders controlled for , the likelihood of cessation was significantly higher in smokers who initiated smoking after age 13 . The hazard ratio for quitting associated with smoking initiation at ages 14 to 16 was 1.6 and with initiation at or after age 17 was 2.0 , compared with initiation at or before 13 years of age . Factors that decreased the likelihood of cessation were nicotine dependence and low education . CONCLUSIONS Public policy to discourage early smoking , if it succeeds in delaying the initiation of smoking , might contribute to the reduction of smoking-related mortality and morbidity by increasing the potential for quitting BACKGROUND This paper examines whether the Massachusetts Tobacco Control Program is affecting the rates of smoking and smokeless tobacco use among Massachusetts ' youth . METHODS School survey data from the Massachusetts Prevalence Study were analyzed to estimate differences between 1993 and 1996 rates of youth cigarette and smokeless tobacco use , attitudes toward smoking , and awareness of cigarette ads and promotions of antismoking messages . RESULTS Lifetime and Current Smoking rates declined significantly among middle school males , contrasting with stable national trends . Among girls in this age group , Lifetime and Current Smoking did not change significantly . Hispanic middle school students exhibited a significant decline in Lifetime Use . There were no significant changes in Lifetime or Current Smoking rates among high school students . Lifetime use of smokeless tobacco declined among middle school students while Current Use declined among both middle and high school students . Students reported declines in awareness of cigarette ads or promotions and increases in awareness of antismoking messages . CONCLUSIONS These results provide evidence for cautious optimism regarding the impact of tobacco control , but indicate that these efforts should begin earlier and that additional research is needed to underst and and address the problems of tobacco use by girls This paper describes the curricula contents , and presents data to evaluate the implementation , process and immediate post-test knowledge of Project Towards No Tobacco Use ( Project TNT ) . Four different school-based tobacco use prevention curricula were developed to counteract the effects of three types of tobacco use acquisition variables typically addressed within a comprehensive social influences program : ( 1 ) peer approval for using tobacco ( normative social influence ) , ( 2 ) incorrect social informational provided about tobacco use ( information social influence ) and ( 3 ) lack of knowledge or misperceptions about physical consequences result ing from tobacco use . Three curricula were design ed to counteract the effects of single acquisition variables , whereas a fourth curriculum was design ed to counteract the effects of combined social and physical consequences-related influences . These curricula were delivered to seventh grade students by trained project health educators to maximize implementation . ' Program ' schools , those schools that received one of these curricula , were compared to ' control ' schools that provided a systematic health education delivered by school personnel . A total of five conditions were contrasted through use of a r and omized experiment involving 48 southern California junior high schools . This paper documents high levels of implementation in all program conditions . Also , favorable process ratings were obtained across the four program conditions , using multiple measures and sources of ratings ( students , health educators and classroom teachers who observed curricula delivery ) . Finally , knowledge item sets completed by the students demonstrated discriminant validity across all five conditions . Because the program conditions were discriminable , yet were quite similar in implementation and process ratings , planned future study of behavioral outcomes can be interpreted as relatively uncontaminated by delivery or credibility confounds
Output:
| CONCLUSIONS New school-based programs are needed to address current issues in tobacco control . |
MS210996 | ***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 yield , economic , and radiation costs of 5 diagnostic algorithms compared with a protocol where all tests are performed ( ultrasonography scan , cystography , and late technetium99dimercaptosuccinic acid scan ) in children after the first febrile urinary tract infections . METHODS : A total of 304 children , 2 to 36 months of age , who completed the diagnostic follow-up ( ultrasonography , cystourethrography , and acute and late technetium99dimercaptosuccinic acid scans ) of a r and omized controlled trial ( Italian Renal Infection Study 1 ) were eligible . The guidelines applied to this cohort in a retrospective simulation were : Melbourne Royal Children ’s Hospital , National Institute of Clinical Excellence ( NICE ) , top down approach , American Academy of Pediatrics ( AAP ) , and Italian Society of Pediatric Nephrology . Primary outcomes were the yield of abnormal tests for each diagnostic protocol ; secondary outcomes were the economic and radiation costs . RESULTS : Vesicoureteral reflux ( VUR ) was identified in 66 ( 22 % ) children and a parenchymal scarring was identified in 45 ( 15 % ) . For detection of VUR ( 47/66 ) and scarring ( 45/45 ) , the top down approach showed the highest sensitivity ( 76 % and 100 % , respectively ) but also the highest economic and radiation costs ( € 52 268 . 624 mSv ) . NICE ( 19/66 ) and AAP ( 18/66 ) had the highest specificities for VUR ( 90 % ) and the Italian Society of Pediatric Nephrology had the highest specificity ( 20/45 ) for scars ( 86 % ) . NICE would have been the least costly ( € 26 838 ) and AAP would have result ed in the least radiation exposure ( 42 mSv ) . CONCLUSIONS : There is no ideal diagnostic protocol following a first febrile urinary tract infection . An aggressive protocol has a high sensitivity for detecting VUR and scarring but carries high financial and radiation costs with question able benefit Abstract . We attempted to verify in a group of 101 children with first urinary tract infection whether it was possible to identify groups of patients with different risks of developing renal scarring by taking into account both the extent of kidney involvement documented in the acute phase of infection using a dimercaptosuccinic acid ( DMSA ) scan , and the presence or absence of vesicoureteral reflux ( VUR ) . The frequency of persistent lesions in kidneys with mild-moderate lesions ( less than 50 % of kidney involvement ) in the presence of VUR or in non-refluxing kidneys was similar ( P=0.1447 ) , while the frequency of persistent lesions in kidneys with severe lesions in the presence of VUR was significantly higher than the frequency of persistent lesions in non-refluxing kidneys ( P=0.0089 ) . The extent of kidney involvement and the presence of VUR make possible the identification of different categories of risk of scarring : in the ” low risk group ” ( normal kidney with/without VUR ) the risk of scarring is 0 % ; in the ” intermediate risk group ” ( mild lesions with/without VUR ; extensive lesions without VUR ) the risk of scarring is between 14 % and 38 % , while in the ” high risk group ” ( extensive lesions with VUR ) the risk of scarring is 88 % . Quantifying the risk of scarring could help in planning the treatment or in modifying the later strategy BACKGROUND Guidelines from the American Academy of Pediatrics recommend obtaining a voiding cystourethrogram and a renal ultrasonogram for young children after a first urinary tract infection ; renal scanning with technetium-99m-labeled dimercaptosuccinic acid has also been endorsed by other authorities . We investigated whether imaging studies altered management or improved outcomes in young children with a first febrile urinary tract infection . METHODS In a prospect i ve trial involving 309 children ( 1 to 24 months old ) , an ultrasonogram and an initial renal scan were obtained within 72 hours after diagnosis , contrast voiding cystourethrography was performed one month later , and renal scanning was repeated six months later . RESULTS The ultrasonographic results were normal in 88 percent of the children ( 272 of 309 ) ; the identified abnormalities did not modify management . Acute pyelonephritis was diagnosed in 61 percent of the children ( 190 of 309 ) . Thirty-nine percent of the children who underwent cystourethrography ( 117 of 302 ) had vesicoureteral reflux ; 96 percent of these children ( 112 of 117 ) had grade I , II , or III vesicoureteral reflux . Repeated scans were obtained for 89 percent of the children ( 275 of 309 ) ; renal scarring was noted in 9.5 percent of these children ( 26 of 275 ) . CONCLUSIONS An ultrasonogram performed at the time of acute illness is of limited value . A voiding cystourethrogram for the identification of reflux is useful only if antimicrobial prophylaxis is effective in reducing reinfections and renal scarring . Renal scans obtained at presentation identify children with acute pyelonephritis , and scans obtained six months later identify those with renal scarring . The routine performance of urinalysis , urine culture , or both during subsequent febrile illnesses in all children with a previous febrile urinary tract infection will probably obviate the need to obtain either early or late scans BACKGROUND Antibiotics are widely administered to children with the intention of preventing urinary tract infection , but adequately powered , placebo-controlled trials regarding efficacy are lacking . This study from four Australian centers examined whether low-dose , continuous oral antibiotic therapy prevents urinary tract infection in predisposed children . METHODS We r and omly assigned children under the age of 18 years who had had one or more microbiologically proven urinary tract infections to receive either daily trimethoprim-sulfamethoxazole suspension ( as 2 mg of trimethoprim plus 10 mg of sulfamethoxazole per kilogram of body weight ) or placebo for 12 months . The primary outcome was microbiologically confirmed symptomatic urinary tract infection . Intention-to-treat analyses were performed with the use of time-to-event data . RESULTS From December 1998 to March 2007 , a total of 576 children ( of 780 planned ) underwent r and omization . The median age at entry was 14 months ; 64 % of the patients were girls , 42 % had known vesicoureteral reflux ( at least grade III in 53 % of these patients ) , and 71 % were enrolled after the first diagnosis of urinary tract infection . During the study , urinary tract infection developed in 36 of 288 patients ( 13 % ) in the group receiving trimethoprim-sulfamethoxazole ( antibiotic group ) and in 55 of 288 patients ( 19 % ) in the placebo group ( hazard ratio in the antibiotic group , 0.61 ; 95 % confidence interval , 0.40 to 0.93 ; P = 0.02 by the log-rank test ) . In the antibiotic group , the reduction in the absolute risk of urinary tract infection ( 6 percentage points ) appeared to be consistent across all subgroups of patients ( P > or = 0.20 for all interactions ) . CONCLUSIONS Long-term , low-dose trimethoprim-sulfamethoxazole was associated with a decreased number of urinary tract infections in predisposed children . The treatment effect appeared to be consistent but modest across subgroups . ( Australian New Zeal and Clinical Trials Registry number , ACTRN12608000470392 . A prospect i ve blind study comparing the findings of ultrasonography , intravenous pyelography , and voiding cystourethrography was conducted on 81 patients to examine the place of ultrasonography in the initial radiologic evaluation of children with urinary tract infection . The patients ' mean age was 4.8 years ; 15 were male . Forty-eight were in patients ( mean age , 3.2 years ) and 33 were out patients ( mean age 7.2 years ) . In 29 patients ( 35.8 % ) abnormality of the urinary system was detected by one or more of the three imaging procedures ; 21 were in patients and eight were out patients . The most frequent finding was vesicoureteral reflux , occurring in 62.1 % of the pathologic cases . The findings at ultrasonography correlated well with those of intravenous pyelography in 73 of the 81 studies ( 90.1 % ) , but they failed to demonstrate double collecting systems and several of the minor changes . However , ultrasonography in combination with cystourethrography identified all patients who had abnormal urinary systems , except for two children with negligible findings . Moreover , ultrasonography and cystourethrography together identified all 11 patients , nine of them in patients , in whom surgical treatment was indicated . It is concluded that ultrasonography can successfully replace intravenous pyelography as a screening imaging procedure for the urinary system , but because of the superiority of intravenous pyelography in the detection of some types of lesions , intravenous pyelography will be required whenever ultrasonography or cystourethrography results are abnormal . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVE To track the clinical evolution of febrile urinary tract infection ( UTI ) diagnosed in 0- to 3-month-old infants and characterize uropathogen frequencies , antimicrobial resistance rates , renal abnormalities , and differences in the sexes in this age group . STUDY DESIGN We observed prospect ively 46 infants identified in a cohort of 209 children with first UTI diagnosed between July 2006 and July 2008 at the age of 0 to 3 months . Renal ultrasound scanning and voiding cystourethrography examinations were performed in all infants . RESULTS Infants < 3 months old represented 21 % of all children with first UTI . Of these children , 26 % were female and 74 % were male . Escherichia coli was isolated in 88 % of cases and had a high rate of resistance to ampicillin ( 71 % ) and to trimethoprim/sulfamethoxazole ( 47 % ) ; 21 % of children had vesicoureteral reflux , which was of low- grade in 67 % of cases , with spontaneous resolution before 2 years in all cases . In infants with normal ultrasound scanning results , a low- grade vesicoureteral reflux was subsequently found in 10 % of cases . CONCLUSION Infants aged 0 to 3 months represent 21 % of children treated for febrile UTI . Boys represent 74 % of these cases . E coli is responsible for 88 % of UTIs , with a high rate of resistance to antibiotics . When ultrasound scanning examination results are normal , the risk of missing a significant renal abnormality is expected to be extremely low This prospect i ve study was done to assess the frequency of acute pyelonephritis ( APN ) in febrile children with positive urine culture as documented by Tc99 m DMSA scintigraphy ( DMSA ) and the frequency of vesicoureteric reflux ( VUR ) in these children . Secondly , to determine the frequency of APN , in febrile children with supportive evidence for UTI but with negative urine culture , as documented by DMSA and frequency of VUR in them . Thirdly to stress the utility of DMSA to diagnose APN in urine culture negative febrile children and to suggest DMSA as a clinical tool in evaluation of fever of unknown origin ( FUO ) . This study included 42 children with positive urine culture and 26 children with negative urine culture who had supportive evidence of UTI as determined by the predetermined criteria and diagnosed to have APN by DMSA . All of them had ultrasonogram ( USG ) , DMSA and voiding cystourethrogram ( VCU ) . They were followed up for a minimum period of 6 months . Out of the 42 children with positive urine culture 92.9 % had features of APN in the DMSA of whom 82.1 % had vesicoureteric relux ( VUR ) . The DMSA was abnormal in 26 children with negative urine culture , of whom 65.4 % had VUR . Ultrasound suggestive of parenchymal change was observed in 47.6 % in the culture positive group and 65.4 % in the culture negative group . In conclusion , it is suggested , that DMSA is a useful investigation for the diagnosis of APN in febrile UTI . DMSA is indicated in febrile children with negative urine culture but with supportive evidence of UTI and in FUO . An abnormal DMSA is a strong indication for work up for VUR We assessed the role of therapeutic delay time ( TDT ) in acute renal cortical scintigraphic lesion ( ASL ) and ultimate scar formation ( USF ) in children with first febrile UTI and whether it is affected by the presence of vesico-ureteral reflux ( VUR ) . 230 children , 90 girls and 140 boys with first febrile UTI were included . Radiologic ( USG , DMSA , and VCUG ) , clinical ( age , gender , peak fever , therapeutic delay time ) and laboratory ( CBC with differential count , ANC ( absolute neutroph
Output:
| Neither the renal ultrasound nor the DMSA scan is accurate enough to detect VUR ( of all grade s ) .
Although a child with a negative DMSA test has an < 1 % probability of having high- grade VUR , performing a screening DMSA will result in a large number of children falsely labelled as being at risk for high- grade VUR . |
MS210997 | ***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: Objectives : To assess the effectiveness of multidisciplinary rehabilitation in the treatment of fibromyalgia in comparison to st and ard medical care . Methods : Seventy-nine men and women were r and omly assigned to one of two groups . The intervention group consisted of a rheumatologist and physical therapist intake and discharge , 18 group supervised exercise therapy sessions , 2 group pain and stress management lectures , 1 group education lecture , 1 group dietary lecture , and 2 massage therapy sessions . The control group consisted of st and ard medical care with the patients ' family physician . Outcome measures included self-perceived health status , pain-related disability , average pain intensity , depressed mood , days in pain , hours in pain , prescription and nonprescription medication usage , and work status . Outcomes were measured at the end of the 6-week intervention and at 15-month follow-up . Results : Thirty-five out of 43 patients from the intervention group and 36 out of 36 patients from the control group completed the study . There were no statistically significant differences between the 2 groups prior to intervention . Intention-to-treat analysis revealed that the intervention group , in comparison to the control group , experienced statistically significant changes at intervention completion in self-perceived health status , average pain intensity , pain related disability , depressed mood , days in pain , and hours in pain , but no significant differences in nonprescription drug use , prescription drug use , or work status . At 15 months , all health outcomes retained their significance except health status . Nonprescription and prescription drug use demonstrated significant reductions at 15 months . Binary logistic regression indicated that long-term changes in Pain Disability Index were influenced by long-term exercise adherence and income status . Conclusions : Positive health-related outcomes in this mostly unresponsive condition can be obtained with a low-cost , group multidisciplinary intervention in a community-based , non clinical setting Background Massage is increasingly used to manage chronic pain but its benefit has not been clearly established . The aim of the study is to determine the effectiveness of a single session of nurse-administered massage for the short term relief of chronic non-malignant pain and anxiety . Methods A r and omised controlled trial design was used , in which the patients were assigned to a massage or control group . The massage group received a 15 minute manual massage and the control group a 15 minute visit to talk about their pain . Adult patients attending a pain relief unit with a diagnosis of chronic pain whose pain was described as moderate or severe were eligible for the study . An observer blind to the patients ' treatment group carried out assessment s immediately before ( baseline ) , after treatment and 1 , 2 , 3 and 4 hours later . Pain was assessed using 100 mm visual analogue scale and the McGill Pain Question naire . Pain Relief was assessed using a five point verbal rating scale . Anxiety was assessed with the Spielberger short form State-Trait Anxiety Inventory . Results 101 patients were r and omised and evaluated , 50 in the massage and 51 in the control group . There were no statistically significant differences between the groups at baseline interview . Patients in the massage but not the control group had significantly less pain compared to baseline immediately after and one hour post treatment . 95 % confidence interval for the difference in mean pain reduction at one hour post treatment between the massage and control groups is 5.47 mm to 24.70 mm . Patients in the massage but not the control group had a statistically significant reduction in anxiety compared to baseline immediately after and at 1 hour post treatment . Conclusion Massage is effective in the short term for chronic pain of moderate to severe intensity . Trial Registration [ IS RCT N98406653 To evaluate the impact of music on opioid requirements and pain levels during renal lithotripsy using alfentanil patient-controlled analgesia ( PCA ) , we conducted a prospect i ve , blinded , r and omized controlled trial . Patients undergoing lithotripsy were instructed in PCA use and asked to rate their anxiety and select their preferred type of music . They were then premedicated with morphine and ketorolac and r and omly allocated into two groups . Group 1 ( n = 97 ) had music started 10 min before the procedure and maintained until 10 min after its conclusion . Group 2 ( n = 96 ) had music begun at the conclusion of lithotripsy and continued for 10 min . Pain intensity , alfentanil requirement , side effects , quality of analgesia , patient satisfaction , and acceptance of the technique were evaluated . Demographics , alfentanil requirement , pain levels , side effects , quality of analgesia , and patient satisfaction were similar in both groups . The addition of music did not provide any benefit . This result raises the possibility that some nonpharmacologic therapies have minimal impact in setting s where the painful stimulus is moderate to severe and adequate pharmacotherapy is available OBJECTIVE Studies have suggested that the Arthritis Self-Management Program ( ASMP ) course is effective at reducing arthritis pain and health care costs in volunteer participants . There have been no reports of trials of the ASMP in the context of primary care physicians ' practice s , where the potential for spreading the program may be greatest . We conducted a r and omized controlled trial of the ASMP course in a large primary care physician network . METHODS Patients with osteoarthritis , rheumatoid arthritis , or fibromyalgia were recruited for the study . Subjects in the intervention practice s received the 6 week course and those in the control practice s received only the ASMP book , without course . Disability , pain , self-efficacy , mental health , and satisfaction were measured using vali date d instruments at baseline and at 4 months . RESULTS One hundred thirteen patients were recruited for the ASMP course ( intervention ) and completed baseline and 4 month followup question naires . Eighty-four percent completed at least 4 of 6 classes . Seventy-four patients received the ASMP manual ( controls ) and completed both question naires . Patients in the intervention and control groups had similar baseline pain ( p = 0.94 ) , self-efficacy to control pain ( p = 0.90 ) , mental health ( p = 0.10 ) , and vitality scores ( p = 0.21 ) , but those in the intervention arm had slightly less disability ( p = 0.04 ) . At 4 months , there was no significant improvement from baseline in any endpoint and no difference between patients in the intervention and control groups ( all p > 0.2 ) . Patient satisfaction with arthritis care and outcomes was no different for intervention and control patients ( all p > 0.3 ) . All types of health care re source use were similar at baseline and followup for both intervention and control groups ( all p > 0.2 ) . CONCLUSION While the ASMP course has been found to be effective in other patient groups , there were no significant clinical benefits noted at 4 months in patients recruited from primary care practice Objective To determine the effectiveness of lessons in the Alex and er technique , massage therapy , and advice from a doctor to take exercise ( exercise prescription ) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain . Design Factorial r and omised trial . Setting 64 general practice s in Engl and . Participants 579 patients with chronic or recurrent low back pain ; 144 were r and omised to normal care , 147 to massage , 144 to six Alex and er technique lessons , and 144 to 24 Alex and er technique lessons ; half of each of these groups were r and omised to exercise prescription . Interventions Normal care ( control ) , six sessions of massage , six or 24 lessons on the Alex and er technique , and prescription for exercise from a doctor with nurse delivered behavioural counselling . Main outcome measures Rol and Morris disability score ( number of activities impaired by pain ) and number of days in pain . Results Exercise and lessons in the Alex and er technique , but not massage , remained effective at one year ( compared with control Rol and disability score 8.1 : massage −0.58 , 95 % confidence interval −1.94 to 0.77 , six lessons −1.40 , −2.77 to −0.03 , 24 lessons −3.4 , −4.76 to −2.03 , and exercise −1.29 , −2.25 to −0.34 ) . Exercise after six lessons achieved 72 % of the effect of 24 lessons alone ( Rol and disability score −2.98 and −4.14 , respectively ) . Number of days with back pain in the past four weeks was lower after lessons ( compared with control median 21 days : 24 lessons −18 , six lessons −10 , massage −7 ) and quality of life improved significantly . No significant harms were reported . Conclusions One to one lessons in the Alex and er technique from registered teachers have long term benefits for patients with chronic back pain . Six lessons followed by exercise prescription were nearly as effective as 24 lessons . Trial registration National Research Register N0028108728 . How does the Alex and er Technique work ? What are the authors findings about the clinical and cost effectiveness of the treatment ? Watch this video to find out ( 12 mins ) . A cognitive-behavioral pain management program for elderly nursing home residents with chronic pain was compared with an attention/support control treatment in a r and omized pre-/post-comparison group design with follow-up . Thirteen women and nine men , ranging in age from 61 to 98 ( M = 77.2 ) , from two large nursing homes participated in the treatment programs through 10 weekly group sessions . Results revealed that the subjects who received the cognitive-behavioral training reported less pain and pain-related disability , although the two programs were perceived as equally credible both before and after treatment . No significant treatment effects were found for depression and physician medication ratings . Treatment effects were maintained at 4-month follow-up , despite an overall increase in reported pain . Findings indicate that elderly nursing home residents with chronic pain and without serious cognitive impairment can benefit substantially from training in cognitive and behavioral pain management strategies that are known to be effective with younger age groups and the community-resident elderly population OBJECTIVE To determine if the chronic pain frequently presented by postpolio patients can be relieved by application of magnetic fields applied directly over an identified pain trigger point . DESIGN Double-blind r and omized clinical trial . SETTING The postpolio clinic of a large rehabilitation hospital . PATIENTS Fifty patients with diagnosed postpolio syndrome who reported muscular or arthritic-like pain . INTERVENTION Application of active or placebo 300 to 500 Gauss magnetic devices to the affected area for 45 minutes . MAIN OUTCOME MEASURE Score on the McGill Pain Question naire . RESULTS Patients who received the active device experienced an average pain score decrease of 4.4 + /- 3.1 ( p < .0001 ) on a 10-point scale . Those with the placebo devices experienced a decrease of 1.1 + /- 1.6 points ( p < .005 ) . The proportion of patients in the active-device group who reported a pain score decrease greater than the average placebo effect was 76 % , compared with 19 % in the placebo-device group ( p < .0001 ) . CONCLUSIONS The application of a device delivering static magnetic fields of 300 to 500 Gauss over a pain trigger point results in significant and prompt relief of pain in postpolio subjects BACKGROUND Chronic pain is recognised as an important problem in the community but our underst and ing of the epidemiology of chronic pain remains limited . We undertook a study design ed to quantify and describe the prevalence and distribution of chronic pain in the community . METHODS A r and om sample of 5036 patients , aged 25 and over , was drawn from 29 general practice s in the Grampian region of the UK and surveyed by a postal self-completion question naire . The question naire included case-screening questions , a question on the cause of the pain , the chronic pain grade question naire , the level of expressed needs question naire , and sociodemographic questions . FINDINGS 3605 question naires were returned completed . 1817 ( 50.4 % ) of patients self reported chronic pain , equivalent to 46.5 % of the general population . 576 reported back pain and 570 reported arthritis ; these were the most common complaints and accounted for a third of all complaints . Backward stepwise logistic-regression modelling identified age , sex , housing tenure , and employment status as significant predictors of the presence of chronic pain in the community . 703 ( 48.7 % ) individuals with chronic pain had the least severe grade of pain , and 228 ( 15.8 % ) the most severe grade . Of those who reported chronic pain , 312 ( 17.2 % ) reported no expressed need , and 509 ( 28.0 % ) reported the highest expressed need . INTERPRETATION Chronic pain is a major problem in the community and certain groups within the population are more likely to have chronic pain . A detailed underst and ing of the epidemiology of chronic pain is essential for efficient management of chronic pain in primary care Objective : To evaluate the efficacy of a treatment programme for patients with fibromyalgia ( FM ) based on self management , using pool exercises and education . Methods : R and omised controlled trial with a 6 month follow up to evaluate an outpatient multidisciplinary programme ; 164 patients with FM were allocated to an immediate 6 week programme ( n = 84 ) or to a waiting list control group ( n = 80 ) . The main outcomes were changes in quality of life , functional consequences , patient satisfaction and pain , using a combination of patient question naires and clinical examinations . The question naires included the Fibromyalgia Impact Question naire ( FIQ ) , Psychological General Well-Being ( PGWB ) index , regional pain score diagrams , and patient satisfaction measures . Results : 61 participants in the treatment group and 68 controls completed the programme and
Output:
| In the end , eight controlled trials were included The main results were : • Cognitive-behavioural and sensorial stimulation programs reduce perceived chronic pain .
• Interventions based on psycho-education and music therapy programs reduce osteoarticular pain .
• Magnetic therapy and guided imagery are interventions that may relieve chronic headache .
• An intervention including a physical exercise program in incontinent elderly increases mobility but does not relieve pain , and may even worsen it .
Other outcome measures showed an improvement in the quality of life ( sensorial stimulation and guided imagery ) , in depression , disability and empowerment ( music therapy ) and physical functioning ( program of psycho-education ) . |
MS210998 | ***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 Whether closure of a patent foramen ovale is effective in the prevention of recurrent ischemic stroke in patients who have had a cryptogenic stroke is unknown . We conducted a trial to evaluate whether closure is superior to medical therapy alone in preventing recurrent ischemic stroke or early death in patients 18 to 60 years of age . METHODS In this prospect i ve , multicenter , r and omized , event-driven trial , we r and omly assigned patients , in a 1:1 ratio , to medical therapy alone or closure of the patent foramen ovale . The primary results of the trial were analyzed when the target of 25 primary end-point events had been observed and adjudicated . RESULTS We enrolled 980 patients ( mean age , 45.9 years ) at 69 sites . The medical-therapy group received one or more antiplatelet medications ( 74.8 % ) or warfarin ( 25.2 % ) . Treatment exposure between the two groups was unequal ( 1375 patient-years in the closure group vs. 1184 patient-years in the medical-therapy group , P=0.009 ) owing to a higher dropout rate in the medical-therapy group . In the intention-to-treat cohort , 9 patients in the closure group and 16 in the medical-therapy group had a recurrence of stroke ( hazard ratio with closure , 0.49 ; 95 % confidence interval [ CI ] , 0.22 to 1.11 ; P=0.08 ) . The between-group difference in the rate of recurrent stroke was significant in the prespecified per- protocol cohort ( 6 events in the closure group vs. 14 events in the medical-therapy group ; hazard ratio , 0.37 ; 95 % CI , 0.14 to 0.96 ; P=0.03 ) and in the as-treated cohort ( 5 events vs. 16 events ; hazard ratio , 0.27 ; 95 % CI , 0.10 to 0.75 ; P=0.007 ) . Serious adverse events occurred in 23.0 % of the patients in the closure group and in 21.6 % in the medical-therapy group ( P=0.65 ) . Procedure-related or device-related serious adverse events occurred in 21 of 499 patients in the closure group ( 4.2 % ) , but the rate of atrial fibrillation or device thrombus was not increased . CONCLUSIONS In the primary intention-to-treat analysis , there was no significant benefit associated with closure of a patent foramen ovale in adults who had had a cryptogenic ischemic stroke . However , closure was superior to medical therapy alone in the prespecified per- protocol and as-treated analyses , with a low rate of associated risks . ( Funded by St. Jude Medical ; RESPECT Clinical Trials.gov number , NCT00465270 . ) Background and Purpose The etiology of ischemic stroke affects prognosis , outcome , and management . Trials of therapies for patients with acute stroke should include measurements of responses as influenced by subtype of ischemic stroke . A system for categorization of subtypes of ischemic stroke mainly based on etiology has been developed for the Trial of Org 10172 in Acute Stroke Treatment ( TOAST ) . Methods A classification of subtypes was prepared using clinical features and the results of ancillary diagnostic studies . “ Possible ” and “ probable ” diagnoses can be made based on the physician 's certainty of diagnosis . The usefulness and interrater agreement of the classification were tested by two neurologists who had not participated in the writing of the criteria . The neurologists independently used the TOAST classification system in their bedside evaluation of 20 patients , first based only on clinical features and then after review ing the results of diagnostic tests . Results The TOAST classification denotes five subtypes of ischemic stroke : 1 ) large-artery atherosclerosis , 2 ) cardioembolism , 3 ) small-vessel occlusion , 4 ) stroke of other determined etiology , and 5 ) stroke of undetermined etiology . Using this rating system , interphysician agreement was very high . The two physicians disagreed in only one patient . They were both able to reach a specific etiologic diagnosis in 11 patients , whereas the cause of stroke was not determined in nine . Conclusions The TOAST stroke subtype classification system is easy to use and has good interobserver agreement . This system should allow investigators to report responses to treatment among important subgroups of patients with ischemic stroke . Clinical trials testing treatments for acute ischemic stroke should include similar methods to diagnose subtypes of stroke BACKGROUND Trials of patent foramen ovale ( PFO ) closure to prevent recurrent stroke have been inconclusive . We investigated whether patients with cryptogenic stroke and echocardiographic features representing risk of stroke would benefit from PFO closure or anticoagulation , as compared with antiplatelet therapy . METHODS In a multicenter , r and omized , open‐label trial , we assigned , in a 1:1:1 ratio , patients 16 to 60 years of age who had had a recent stroke attributed to PFO , with an associated atrial septal aneurysm or large interatrial shunt , to transcatheter PFO closure plus long‐term antiplatelet therapy ( PFO closure group ) , antiplatelet therapy alone ( antiplatelet‐only group ) , or oral anticoagulation ( anticoagulation group ) ( r and omization group 1 ) . Patients with contraindications to anticoagulants or to PFO closure were r and omly assigned to the alternative noncontraindicated treatment or to antiplatelet therapy ( r and omization groups 2 and 3 ) . The primary outcome was occurrence of stroke . The comparison of PFO closure plus antiplatelet therapy with antiplatelet therapy alone was performed with combined data from r and omization groups 1 and 2 , and the comparison of oral anticoagulation with antiplatelet therapy alone was performed with combined data from r and omization groups 1 and 3 . RESULTS A total of 663 patients underwent r and omization and were followed for a mean ( ±SD ) of 5.3±2.0 years . In the analysis of r and omization groups 1 and 2 , no stroke occurred among the 238 patients in the PFO closure group , whereas stroke occurred in 14 of the 235 patients in the antiplatelet‐only group ( hazard ratio , 0.03 ; 95 % confidence interval , 0 to 0.26 ; P<0.001 ) . Procedural complications from PFO closure occurred in 14 patients ( 5.9 % ) . The rate of atrial fibrillation was higher in the PFO closure group than in the antiplatelet‐only group ( 4.6 % vs. 0.9 % , P=0.02 ) . The number of serious adverse events did not differ significantly between the treatment groups ( P=0.56 ) . In the analysis of r and omization groups 1 and 3 , stroke occurred in 3 of 187 patients assigned to oral anticoagulants and in 7 of 174 patients assigned to antiplatelet therapy alone . CONCLUSIONS Among patients who had had a recent cryptogenic stroke attributed to PFO with an associated atrial septal aneurysm or large interatrial shunt , the rate of stroke recurrence was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone . PFO closure was associated with an increased risk of atrial fibrillation . ( Funded by the French Ministry of Health ; CLOSE Clinical Trials.gov number , NCT00562289 . BACKGROUND Whether closure of a patent foramen ovale reduces the risk of recurrence of ischemic stroke in patients who have had a cryptogenic ischemic stroke is unknown . METHODS In a multicenter , r and omized , open‐label trial , with blinded adjudication of end‐point events , we r and omly assigned patients 18 to 60 years of age who had a patent foramen ovale ( PFO ) and had had a cryptogenic ischemic stroke to undergo closure of the PFO ( PFO closure group ) or to receive medical therapy alone ( aspirin , warfarin , clopidogrel , or aspirin combined with extended‐release dipyridamole ; medical‐therapy group ) . The primary efficacy end point was a composite of recurrent nonfatal ischemic stroke , fatal ischemic stroke , or early death after r and omization . The results of the analysis of the primary outcome from the original trial period have been reported previously ; the current analysis of data from the extended follow‐up period was considered to be exploratory . RESULTS We enrolled 980 patients ( mean age , 45.9 years ) at 69 sites . Patients were followed for a median of 5.9 years . Treatment exposure in the two groups was unequal ( 3141 patient‐years in the PFO closure group vs. 2669 patient‐years in the medical‐therapy group ) , owing to a higher dropout rate in the medical‐therapy group . In the intention‐to‐treat population , recurrent ischemic stroke occurred in 18 patients in the PFO closure group and in 28 patients in the medical‐therapy group , result ing in rates of 0.58 events per 100 patient‐years and 1.07 events per 100 patient‐years , respectively ( hazard ratio with PFO closure vs. medical therapy , 0.55 ; 95 % confidence interval [ CI ] , 0.31 to 0.999 ; P=0.046 by the log‐rank test ) . Recurrent ischemic stroke of undetermined cause occurred in 10 patients in the PFO closure group and in 23 patients in the medical‐therapy group ( hazard ratio , 0.38 ; 95 % CI , 0.18 to 0.79 ; P=0.007 ) . Venous thromboembolism ( which comprised events of pulmonary embolism and deep‐vein thrombosis ) was more common in the PFO closure group than in the medical‐therapy group . CONCLUSIONS Among adults who had had a cryptogenic ischemic stroke , closure of a PFO was associated with a lower rate of recurrent ischemic strokes than medical therapy alone during extended follow‐up . ( Funded by St. Jude Medical ; RESPECT Clinical Trials.gov number , NCT00465270 . BACKGROUND The efficacy of closure of a patent foramen ovale ( PFO ) in the prevention of recurrent stroke after cryptogenic stroke is uncertain . We investigated the effect of PFO closure combined with antiplatelet therapy versus antiplatelet therapy alone on the risks of recurrent stroke and new brain infa rct ions . METHODS In this multinational trial involving patients with a PFO who had had a cryptogenic stroke , we r and omly assigned patients , in a 2:1 ratio , to undergo PFO closure plus antiplatelet therapy ( PFO closure group ) or to receive antiplatelet therapy alone ( antiplatelet‐only group ) . Imaging of the brain was performed at the baseline screening and at 24 months . The co primary end points were freedom from clinical evidence of ischemic stroke ( reported here as the percentage of patients who had a recurrence of stroke ) through at least 24 months after r and omization and the 24‐month incidence of new brain infa rct ion , which was a composite of clinical ischemic stroke or silent brain infa rct ion detected on imaging . RESULTS We enrolled 664 patients ( mean age , 45.2 years ) , of whom 81 % had moderate or large interatrial shunts . During a median follow‐up of 3.2 years , clinical ischemic stroke occurred in 6 of 441 patients ( 1.4 % ) in the PFO closure group and in 12 of 223 patients ( 5.4 % ) in the antiplatelet‐only group ( hazard ratio , 0.23 ; 95 % confidence interval [ CI ] , 0.09 to 0.62 ; P=0.002 ) . The incidence of new brain infa rct ions was significantly lower in the PFO closure group than in the antiplatelet‐only group ( 22 patients [ 5.7 % ] vs. 20 patients [ 11.3 % ] ; relative risk , 0.51 ; 95 % CI , 0.29 to 0.91 ; P=0.04 ) , but the incidence of silent brain infa rct ion did not differ significantly between the study groups ( P=0.97 ) . Serious adverse events occurred in 23.1 % of the patients in the PFO closure group and in 27.8 % of the patients in the antiplatelet‐only group ( P=0.22 ) . Serious device‐related adverse events occurred in 6 patients ( 1.4 % ) in the PFO closure group , and atrial fibrillation occurred in 29 patients ( 6.6 % ) after PFO closure . CONCLUSIONS Among patients with a PFO who had had a cryptogenic stroke , the risk of subsequent ischemic stroke was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone ; however , PFO closure was associated with higher rates of device complications and atrial fibrillation . ( Funded by W.L. Gore and Associates ; Gore REDUCE Clinical Trials.gov number , NCT00738894 . BACKGROUND Recent reports showing the favorable role of patent foramen ovale ( PFO ) closure in patients with cryptogenic stroke have raised the issue of selecting optimal c and i date s. OBJECTIVES This study , DEFENSE-PFO ( Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale ) , evaluated whether the benefits of PFO closure can be determined on the basis of the morphologic characteristics of the PFO , as evaluated by transesophageal echocardiography . METHODS Patients with
Output:
| Conclusions In patients aged < 60 years , PFO closure probably confers an important reduction in ischaemic stroke recurrence compared with antiplatelet therapy alone but may make no difference compared with anticoagulation .
PFO closure incurs a risk of persistent atrial fibrillation and device-related adverse events .
Compared with alternatives , anticoagulation probably increases major bleeding . |
MS210999 | ***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 Global Asthma Network ( GAN ) , established in 2012 , followed the International Study of Asthma and Allergies in Childhood ( ISAAC ) . ISAAC Phase One involved over 700 000 adolescents and children from 156 centres in 56 countries ; it found marked worldwide variation in symptom prevalence of asthma , rhinitis and eczema that was not explained by the current underst and ing of these diseases ; ISAAC Phase Three involved over 1 187 496 adolescents and children ( 237 centres in 98 countries ) . It found that asthma symptom prevalence was increasing in many locations especially in low- and middle-income countries where severity was also high , and identified several environmental factors that required further investigation . GAN Phase I , described in this article , builds on the ISAAC findings by collecting further information on asthma , rhinitis and eczema prevalence , severity , diagnoses , asthma emergency room visits , hospital admissions , management and use of asthma essential medicines . The subjects will be the same age groups as ISAAC , and their parents . In this first global monitoring of asthma in children and adults since 2003 , further evidence will be obtained to underst and asthma , management practice s and risk factors , leading to further recognition that asthma is an important non-communicable disease and to reduce its global burden . The Global Asthma Network undertakes global studies of asthma surveillance , management and risk factors The aim of this study was to assess the role of depression as a predictor of new onset of chronic migraine ( CM ) among persons with episodic migraine ( EM ) . The American Migraine Prevalence and Prevention ( AMPP ) study followed 24,000 persons with severe headache identified in 2004 . Using r and om-effects logistic regression , we modeled the probability that persons with EM in 2005 or 2006 would develop CM in the subsequent year . Depression was assessed in two ways , using a vali date d question naire ( PHQ-9 score ≥15 ) and based on self-reported medical diagnosis . Analyses were adjusted for multiple covariates including sociodemographics , body mass index , headache pain intensity , headache frequency , migraine symptom severity , cutaneous allodynia , acute medication overuse , anti-depressant use and anxiety . Of 6,657 participants with EM in 2005 , 160 ( 2.4 % ) developed CM in 2006 . Of 6,852 participants with EM in 2006 , 144 ( 2.2 % ) developed CM in 2007 . In fully adjusted models , PHQ-9 defined depression was a significant predictor of CM onset [ odds ratio ( OR ) = 1.65 , 95 % CI 1.12–2.45 ] . There was a depression-dose effect ; relative to participants with no depression or mild depression , those with moderate ( OR = 1.77 , 95 % CI 1.25–2.52 ) , moderately severe ( OR = 2.35 , 95 % CI 1.53–3.62 ) , and severe depression ( OR = 2.53 , 95 % CI 1.52–4.21 ) were at increased risk for the onset of CM . Among persons with EM , depression was associated with an increased risk of CM after adjusting for sociodemographic variables and headache characteristics . Depression preceded the onset of CM and risk increased with depression severity suggesting a potentially causal role though reverse causality can not be excluded BACKGROUND Data for trends in prevalence of asthma , allergic rhinoconjunctivitis , and eczema over time are scarce . We repeated the International Study of Asthma and Allergies in Childhood ( ISAAC ) at least 5 years after Phase One , to examine changes in the prevalence of symptoms of these disorders . METHODS For the ISAAC Phase Three study , between 2002 and 2003 , we did a cross-sectional question naire survey of 193,404 children aged 6 - 7 years from 66 centres in 37 countries , and 304,679 children aged 13 - 14 years from 106 centres in 56 countries , chosen from a r and om sample of schools in a defined geographical area . FINDINGS Phase Three was completed a mean of 7 years after Phase One . Most centres showed a change in prevalence of 1 or more SE for at least one disorder , with increases being twice as common as decreases , and increases being more common in the 6 - 7 year age-group than in the 13 - 14 year age-group , and at most levels of mean prevalence . An exception was asthma symptoms in the older age-group , in which decreases were more common at high prevalence . For both age-groups , more centres showed increases in all three disorders more often than showing decreases , but most centres had mixed changes . INTERPRETATION The rise in prevalence of symptoms in many centres is concerning , but the absence of increases in prevalence of asthma symptoms for centres with existing high prevalence in the older age-group is reassuring . The divergent trends in prevalence of symptoms of allergic diseases form the basis for further research into the causes of such disorders This cross-sectional clinical study was conducted in order to explore the relationship between atopic disorders and migraine . We evaluated 186 consecutive patients with migraine . Patients with a history of atopic disorders were compared with the others during headache-free intervals , for their headache characteristics , pulmonary test ( PFT ) performances and immunological screenings , through appropriate statistical methods . Of the patients with migraine , 77 ( 41.4 % ) reported at least one atopic disorder . PFT screening showed a general decreased pulmonary capacity and an important correlation between a positive history of atopic disorders and both increased eosinophil and IgE levels in headache-free periods . It should be discussed whether screening with PFT or immunological tests helps in early detection of progressive lung disease which might develop in these patients OBJECTIVE Clinical observation of a decrease in migraine frequency in patients with comorbid asthma taking montelukast , a specific D4 leukotriene receptor antagonist , or zafirlukast , another leukotriene receptor antagonist , prompted us to explore a possible role for leukotriene modifiers in the treatment of migraine . ( A further prompt was a pharmacist colleague 's observation that a number of patients on these agents reported a decreased sensitivity to perfume triggers and improvement in migraine . ) BACKGROUND Nonsteroidal anti-inflammatory agents have been used widely in the treatment of migraine . Another class of anti-inflammatory agents , known as leukotriene modifiers , have not been studied to date with regard to their possible role in the treatment of migraine . The name " leukotriene is derived both from the parent molecule , which was originally isolated from leukocytes , and from its three double-bond carbon backbone or triene structure . Both prostagl and ins and leukotrienes are derived from the metabolism of arachidonic acid , with prostagl and ins coming off the cyclooxygenase pathway and leukotrienes derived via the enzyme 5-lipoxygenase . Both prostagl and ins and leukotrienes mediate inflammatory responses . The latter have been studied with regard to their role in the pathophysiology of asthma . METHODS A prospect i ve , open-label study evaluating the efficacy of montelukast , 10 mg or 20 mg , in the prophylaxis of migraine in 17 patients is presented in this paper . All 17 patients completed the study that consisted of a 2-month baseline run-in period and a 3-month treatment phase . RESULTS Montelukast was extremely well tolerated , and no adverse events were reported by any of the patients . Fifty-three percent showed a reduction of greater than 50 % ( P<.025 ) in the frequency of severe attacks , with 41 % showing a reduction of greater than 60 % . Responders , including modest responders , rated the drug as excellent . CONCLUSIONS We conclude , given the limitations of an open-label study design and the small sample size , that montelukast shows potential as an effective , well-tolerated prophylactic agent in migraine . Double-blinded , placebo-controlled studies are warranted . In addition , the leukotrienes , as suggested previously in the literature , may play a role in the pathogenesis of migraine
Output:
| If two conditions linked , once an individual undergo better control of asthma symptoms , might the excruciating migraine ease , too |
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