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MS212900 | ***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 Surgical noxious stimuli generate a stress response with an increased sympathetic activity , potentially affecting the perioperative outcome . Surgical Pleth Index ( SPI ) , derived from the pulse plethysmogram , has been proposed as a tool to assess nociception-antinociception balance . The relationship between SPI and autonomic nervous system ( ANS ) during general anesthesia is poorly understood and it is doubtful if SPI-guided analgesia may offer advantages over the st and ard clinical practice . The study was design ed to evaluate if SPI-guided analgesia leads to a lower sympathetic modulation compared with st and ard clinical practice . METHODS Electrocardiographic wave , non-invasive blood pressure and SPI were recorded in ASA I-II patients undergoing elective laparoscopic cholecystectomy , r and omized to receive SPI-guided analgesia or st and ard analgesia . Hemodynamic parameters , SPI , mean and variance of heart rate , low ( LF ) and high frequency ( HF ) spectral components of heart rate variability were measured at four time points : ( T0 ) baseline , ( T1 ) after induction of general anesthesia , ( T2 ) after pneumoperitoneum insufflation and ( T3 ) after pneumoperitoneum withdrawal . RESULTS SPI , hemodynamic and ANS parameters changed significantly in both groups during the study period ( P<0.0001 ) . At T2 SPI and markers of sympathetic modulation were significantly lower in SPI group ( mean [ SD ] SPI 38.1 [ 15.3 ] vs. 48.1 [ 16.2 ] normalized units , P<0.05 ; LF 38 [ 8.6 ] vs. 56.2 [ 20.6 ] normalized units , P<0.01 ; LF/HF 1.01 [ 1.1 ] vs. 2.68 [ 2.07 ] , P<0.01 ) . There was no difference in remifentanil consumption , recovery time from anesthesia , or postoperative pain and complications . CONCLUSION SPI-guided analgesia led to a more stable sympathetic modulation but did n't seem to offer clinical ly relevant advantages over the st and ard clinical practice for laparoscopic cholecystectomy Background : Surgical stress index ( SSI ) , a novel multivariate index , has recently been proven to react well to surgical nociceptive stimuli and analgesic drug concentration changes during general anesthesia . We investigated the feasibility of application of SSI for guidance of remifentanil administration during propofol – remifentanil anesthesia . Methods : Eighty patients scheduled for elective ear – nose – throat surgery were r and omized into two groups , SSI-guided analgesia group ( SSI group ) and st and ard practice analgesia group ( control group ) . In both groups , anesthesia was maintained with a propofol target-controlled infusion and adjusted stepwise by 0.5 & mgr;g/ml to keep bispectral index values between 40 and 60 . In the SSI group , the predicted effect-site concentration of remifentanil was adjusted stepwise by 1 ng/ml to keep SSI values between 20 and 50 , whereas in the control group , predicted effect-site concentration of remifentanil was adjusted according to traditional inadequate analgesia criteria . Anesthetics consumption , recovery times , and incidence of unwanted events were recorded . Results : Remifentanil consumption ( average normalized infusion rate ) was lower in the SSI group than in the control group ( mean ± SD , 9.5 ± 3.8 & mgr;g · kg−1 · h−1 vs. 12.3 ± 5.2 & mgr;g · kg−1 · h−1 ; P < 0.05 ) . The number of unwanted events was less in the SSI group ( 84 ) than in the control group ( 556 ; P < 0.01 ) . Recovery times were comparable between groups . No patient reported intraoperative recall . Conclusions : SSI-guided anesthesia result ed in lower remifentanil consumption , more stable hemodynamics , and a lower incidence of unwanted events BACKGROUND Autonomic nervous system ( ANS ) sensitively responds to intraoperative stress . Several indices characterizing the state and responses of autonomic signs to nociceptive stimuli have been introduced . This study evaluated the behaviour of ANS descriptors after induction , before and during tracheal intubation , and during bilateral tonsillectomies after r and om and blinded unilateral infiltration of lidocaine 1 % until emergence from anaesthesia . METHODS Twelve patients undergoing bilateral tonsillectomy were anaesthetized with fentanyl and propofol ( induction ) and sevoflurane ( maintenance ) . All patients were monitored throughout anaesthesia for middle finger temperature , non-invasive arterial pressure , heart rate ( HR ) and pulse rate ( PR ) , state entropy ( SE ) and response entropy ( RE ) , and surgical pleth index ( SPI ) . New parameters complementing the above and characterizing the ANS state ( ANSS ) and responses are pulse-to-pulse interval ( PPI ) , pulse plethysmographic amplitude ( PPGA ) , ANSS , and an index based on maximal ANSS for the subject ( ANSSI ) . Serial data were stored as 10 s averages into a laptop computer . RESULTS Anaesthesia induction was associated with an increase in finger temperature to > 30 degrees C within 10 min , whereas PPGA increased to their maximum levels within 5 min . Laryngoscopy and intubation were associated with transient autonomic responses in most patients . All autonomic signs indicated statistically significant sympathetic activation during saline-infiltrated tonsillectomies when compared with lidocaine-infiltrated sides ( P<0001 ) . Hypnotic measures ( SE and RE ) and finger temperatures did not differ between the sides . CONCLUSIONS HR , PPI , PPGA , ANSS , ANSSI , SPI , and RE-SE detect autonomic responses to nociceptive stimuli and differentiate between tonsillectomies on locally anaesthetized tonsils from controls Being highly unstable , the critically ill polytrauma patient represents a challenge for the anaesthesia team . The aim of this study was to compare the Entropy and Surgical Pleth Index (SPI)—guided general anaesthesia with st and ard haemodynamic monitoring methods used in the critically ill polytrauma patients and to evaluate the incidence of hemodynamic events , as well as the opioid and vasopressor dem and . 72 patients were included in this prospect i ve observational study , divided in two groups , the ESPI Group ( N = 37 , patients that benefited from Entropy and SPI monitoring ) and the STDR Group ( N = 35 patients that benefited from st and ard hemodynamic monitoring ) . In the ESPI Group general anaesthesia was modulated in order to maintain the Entropy levels between 40 and 60 . Analgesia control was achieved by maintaining the SPI levels between 20 and 50 . In the STDR Group hypnosis and analgesia were maintained using the st and ard criteria based on hemodynamic changes . Clinical Trials.gov identifier NCT03095430 . The incidence of hypotension episodes was significantly lower in the ESPI Group ( N = 3 ) , compared to the STDR Group ( N = 71 ) ( p < 0.05 ) . Moreover , the Fentanyl dem and was significantly lower in the ESPI Group ( p < 0.0001 , difference between means 5.000 ± 0.038 , 95 % confidence interval 4.9250–5.0750 ) , as well as vasopressor medication dem and ( p < 0.0001 , difference between means 0.960 ± 0.063 , 95 % confidence interval 0.8.334–1.0866 ) . The implementation of multimodal monitoring in the critically ill polytrauma patient brings substantial benefits both to the intraoperative clinical status and to the clinical outcome of these patients by reducing the incidence of anesthesia-related complications Background : The effectiveness of surgical pleth index ( SPI ) for managing nociception-antinociception balance during general anesthesia with vasodilators , including nicardipine has not been demonstrated . We aim ed to compare the time course during surgery in SPI values in patients receiving nicardipine or remifentanil infusion during thyroidectomy . Methods : Forty patients undergoing thyroidectomy were r and omly assigned to receive nicardipine ( group N ; n = 19 ) or remifentanil ( group R ; n = 21 ) along with induction ( propofol , fentanyl , and rocuronium ) and maintenance ( 50 % desflurane/nitrous oxide in oxygen ) anesthesia ( goal bispectral index [ BIS ] ∼50 ) . The infusion of nicardipine or remifentanil was started before the 1st incision and adjusted to keep mean blood pressure ( MBP ) within ±20 % of the preoperative value . SPI , BIS , end-tidal desflurane concentration ( EtDes ) , MBP , and heart rate were recorded at 2.5 minute intervals from the 1st incision to the end of surgery . Extubation and recovery times , pain score/rescue ketorolac consumption , and adverse events in postanesthesia care unit ( PACU ) were recorded . Results : The trend of SPI during surgery was comparable between the 2 groups ( P = 0.804 ) , although the heart rates in group N were significantly higher than those in group R ( P = 0.040 ) . The patient characteristics , trends of BIS , EtDes , and MBP during surgery , extubation and recovery times , and incidence of nausea/vomiting were comparable between the groups . Group N had significantly lower pain scores and rescue ketorolac consumption at PACU . Conclusion : SPI was comparable between patients receiving nicardipine or remifentanil infusion during thyroidectomy under general anesthesia , which suggests that the administration of nicardipine may confound the interpretation of SPI values during general anesthesia . Clinical trial registration : This trial was registered in the UMIN clinical trials registry ( unique trial number : UMIN000019058 ; registration number : R000022028 ; principal investigator 's name : Young Ju Won ; date of registration : September 17 , 2015 ) BACKGROUND Monitoring of analgesia remains a challenge during general anaesthesia . The surgical stress index ( SSI ) is derived from the photoplethysmographic waveform amplitude and the heart beat-to-beat interval . We evaluated the ability of SSI to measure surgical stress in patients undergoing gynaecological laparoscopy . Our hypothesis was that while keeping State Entropy ( SE ) at a predetermined level , SSI would be higher in patients receiving a beta-blocking agent ( esmolol ) than in those receiving an opioid ( remifentanil ) during laparoscopy . METHODS Thirty women undergoing gynaecological laparoscopy were assigned r and omly to receive esmolol ( n = 15 ) or remifentanil ( n = 15 ) . Anaesthesia was induced with propofol and fentanyl and maintained with desflurane and nitrous oxide 50 % in oxygen to keep SE at 50(5 ) . The infusion of esmolol or remifentanil was started before laparoscopy and adjusted to keep the systolic blood pressure at -20 to + 10 % from the preoperative value . RESULTS During the fentanyl phase , before surgery , both groups behaved similarly , with an increase in SSI after intubation . In the patients receiving esmolol , the SSI reacted to the initial incision ( P < 0.05 ) , and remained high after trocar insertion ( P < 0.05 ) . In patients receiving remifentanil , it did not react to the initial incision , but increased after trocar insertion ( P < 0.05 ) , and it remained lower both after incision ( P < 0.05 ) and after trocar insertion ( P < 0.05 ) . CONCLUSION SSI was higher in patients receiving esmolol . The index seems to reflect the level of surgical stress and may help guide the use of opioids during general anaesthesia Background : The surgical pleth index ( SPI ) is proposed for titration of analgesic drugs during general anesthesia . Several reports have investigated the effect of SPI on the consumption of opioids including remifentanil , fentanyl , and sufentanil during anesthesia , but there are no reports about oxycodone . We aim ed to investigate intravenous oxycodone consumption between SPI-guided analgesia and conventional analgesia practice s during sevoflurane anesthesia in patients undergoing thyroidectomy . Methods : Forty-five patients undergoing elective thyroidectomy were r and omly assigned to an SPI group ( SPI-guided analgesia group , n = 23 ) or a control group ( conventional analgesia group , n = 22 ) . Anesthesia was maintained with sevoflurane to achieve bispectral index values between 40 and 60 . In the SPI group , oxycodone 1 mg was administered intravenously at SPI values over 50 ; in the control group , oxycodone 1 mg was administered intravenously at the occurrence of tachycardia or hypertension event . Intraoperative oxycodone consumption and extubation time were recorded . The number of hemodynamic and somatic movement events was recorded , as were postoperative pain and recovery scores . Results : Patients ’ characteristics were comparable between the groups . Intraoperative oxycodone consumption in the SPI group was significantly lower
Output:
| No significant intergroup difference was observed in the pain score on the first postoperative day or the incidence of perioperative adverse events .
Conclusions Compared with conventional analgesia , SPI-guided analgesia can reduce intraoperative opioid consumption and facilitate extubation .
Moreover , no intergroup difference was observed in the degree of postoperative pain or incidence of perioperative adverse events |
MS212901 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The aim of this study was to assess the relationship between total plasma homocysteine ( tHC ) and several markers of endothelial function , coagulation , and pro-inflammatory status in renal transplant recipients . Our own previous study demonstrated the efficacy of folic acid ( FA ) and vitamin B(12 ) ( B(12 ) ) treatment to reduce tHC . Using 70 stable recipients , 56 of whom showed hyperhomocisteinemia ( HHC ) ( tHC > or = 14 micromol/L ) and a control group ( n = 14 , tHC < 14 micromol/L ) , we treated 29 patients in the HHC group ( 10 mg FA and 500 mg B(12 ) daily ) and determined their endothelial function , inflammatory activity , and coagulation status . We assessed plasma levels of von Willebr and Factor and fibrinogen as the prothrombotic profile and C-reactive protein and plasma albumin as inflammation markers . We performed Doppler sonography of the brachial artery to assess endothelial function . The mean value of plasma tHC of 19.05 + /- 3.70 micromol/L before treatment decreased to 13.45 + /- 3.25 micromol/L after 3 months of treatment ( P < .001 ) . The vWF was significantly correlated with tHC ( P < .05 ) and was higher in the HHC patients ( P < .05 ) . The fibrinogen mean level was also significantly higher in HHC patients ( P < .05 ) . The C-reactive protein level was significantly higher and the albumin level was lower among patients with HHC . The endothelium-dependent dilation ( EDD ) correlated with baseline tHC ( P < .05 ) . In preliminary data we observed that homocysteine-lowering therapy may provide cardiovascular protection by enhancing endothelial function , limiting oxidative stress , and reducing procoagulation status BACKGROUND The hyperhomocysteinemia regularly found in hemodialysis patients is largely refractory to combined oral B-vitamin supplementation featuring supraphysiological doses of folic acid . We evaluated whether a high-dose L-5-methyltetrahydrofolate-based regimen provided improved total homocysteine (tHcy)-lowering efficacy in chronic hemodialysis patients . METHODS AND RESULTS We block-r and omized 50 chronic , stable hemodialysis patients on the basis of their screening predialysis tHcy levels , sex , and dialysis center into 2 groups of 25 subjects treated for 12 weeks with oral folic acid at 15 mg/d ( FA group ) or an equimolar amount ( 17 mg/d ) of oral L-5-methyltetrahydrofolate ( MTHF group ) . All 50 subjects also received 50 mg/d of oral vitamin B(6 ) and 1.0 mg/d of oral vitamin B(12 ) . The mean percent reductions ( + /-95 % CIs ) in predialysis tHcy were not significantly different : MTHF , 17.0 % ( 12.0 % to 22.0 % ) ; FA , 14.8 % ( 9.6 % to 20.1 % ) ; P=0.444 by matched ANCOVA adjusted for pretreatment tHcy . Final on-treatment values ( mean with 95 % CI ) were MTHF , 20.0 micromol/L ( 18.8 to 21.2 micromol/L ) ; FA , 19.5 micromol/L ( 18.3 to 20.7 micromol/L ) . Moreover , neither treatment result ed in " normalization " of tHcy levels ( ie , final on-treatment values < 12 micromol/L ) among a significantly different or clinical ly meaningful number of patients : MTHF , 2 of 25 ( 8 % ) ; FA , 0 of 25 ( 0 % ) ; Fisher 's exact test of between-groups difference , P=0.490 . CONCLUSIONS Relative to high-dose folic acid , high-dose oral L-5-methyltetrahydrofolate-based supplementation does not afford improved tHcy-lowering efficacy in hemodialysis patients . The preponderance of hemodialysis patients ( ie , > 90 % ) exhibit mild hyperhomocysteinemia refractory to treatment with either regimen . This treatment refractoriness is not related to defects in folate absorption or circulating plasma and tissue distribution The mild fasting hyperhomocysteinemia commonly observed in chronic ( ie , > /=6 months posttransplantation ) renal transplant recipients ( RTRs ) can be effectively treated with combined B-vitamin supplementation featuring supraphysiological doses of folic acid . There are no controlled data evaluating the comparative efficacy of supraphysiological versus st and ard multivitamin dose folic acid supplementation in reducing fasting total homocysteine ( tHcy ) levels among RTRs . We block-r and omized 60 chronic , stable RTRs on the basis of their screening fasting tHcy level to 3 groups of 20 subjects treated for 12 weeks with folic acid at either 2.4 ( group 1 ) , 0.4 ( ie , st and ard multivitamin dose ) ( group 2 ) , or 0.0 ( group 3 ) mg/d . All 60 study participants also received 50 mg/d vitamin B(6 ) and 0.4 mg/d vitamin B(12 ) . The mean percent reductions ( + /-SEM ) in fasting tHcy were as follows : group 1 , 32.3+/-2.4 % ; group 2 , 23.4+/-2.3 % ; and group 3 , 19.1+/-2.3 % . ANCOVA accounting for the pretreatment matching and adjusted for pretreatment levels of fasting tHcy , folate , and albumin ; change in creatinine during the study ; and cyclosporine A use revealed significant overall group differences ( P=0.005 ) and significant differences between groups 1 and 2 ( P=0 . 038 ) and groups 1 and 3 ( P=0.001 ) , but not between groups 2 and 3 ( P=0.153 ) . Moreover , a chi(2 ) analysis of participants with pretreatment tHcy levels > /=15 micromol/L ( n=29 ) indicated that a significantly greater proportion of those in group 1 achieved posttreatment levels < 12 micromol/L : group 1 , 5 of 10 ( 50 % ) ; group 2 , 1 of 11 ( 9 % ) ; and group 3 , 0 of 8 ( 0 % ) ( P=0.016 ; test of trend P=0 . 007 ) . We conclude that a supraphysiological dose of folic acid is superior to st and ard multivitamin dosing for the reduction of fasting tHcy levels in chronic RTRs BACKGROUND Mild hyperhomocysteinemia is common among maintenance hemodialysis ( HD ) patients and renal transplant recipients ( RTR ) and may contribute to the excess incidence of arteriosclerotic outcomes experienced by both patient groups . Relative to their RTR counterparts , the hyperhomocysteinemia of HD patients seems to be considerably more refractory to treatment with high-dose folic acid (FA)-based B-vitamin supplementation regimens , although controlled comparison data are lacking . METHODS We compared the relative responsiveness of ( n=10 ) RTR and ( n=39 ) HD patients with equivalent baseline total homocysteine ( tHcy ) levels ( i.e. , RTR range=14.2 - 23.6 micromol/L ; HD range=14.4 - 24.9 micromol/L ) to 12 weeks of tHcy-lowering treatment . The RTR received 2.4 mg/day of FA , 50.0 mg/day of vitamin B6 , and 0.4 mg/day of vitamin B12 , while the HD patients received 15 mg/day of FA or an equimolar amount ( 17 mg/day ) of the reduced folate , L-5-methyltetrahydrofolate , in addition to 50.0 mg/day of vitamin B6 , and 1.0 mg/day of vitamin B12 . RESULTS The mean percent ( % ) reductions ( + /-95 % confidence interval ) in tHcy were : RTR=28.1 % ( 16.2 - 40.0 % ) ; HD=12.1 % ( 6.6 - 17.7 % ) , P=0.027 for comparison of between-groups differences by analysis of covariance adjusted for baseline tHcy levels . Moreover , ( 50.0 % ) of 10 of the RTR versus only ( 5.1 % ) of 39 of the HD patients had final on-treatment tHcy levels < 12 micromol/L ; P=0.002 for comparison of between-groups differences by Fisher 's exact test . CONCLUSION Relative to RTR with comparable baseline tHcy levels , the mild hyperhomocysteinemia of maintenance HD patients is much more refractory to tHcy-lowering B-vitamin treatment regimens featuring supraphysiological amounts of FA or the reduced folate , L-5-methyltetrahydrofolate . Accordingly , RTR are a preferable target population for controlled clinical trials testing the hypothesis that tHcy-lowering B-vitamin intervention may reduce arteriosclerotic cardiovascular disease event rates in patients with chronic renal disease BACKGROUND Homocysteine is a risk factor for cardiovascular disease . We evaluated the efficacy of homocysteine-lowering treatment with B vitamins for secondary prevention in patients who had had an acute myocardial infa rct ion . METHODS The trial included 3749 men and women who had had an acute myocardial infa rct ion within seven days before r and omization . Patients were r and omly assigned , in a two-by-two factorial design , to receive one of the following four daily treatments : 0.8 mg of folic acid , 0.4 mg of vitamin B12 , and 40 mg of vitamin B6 ; 0.8 mg of folic acid and 0.4 mg of vitamin B12 ; 40 mg of vitamin B6 ; or placebo . The primary end point during a median follow-up of 40 months was a composite of recurrent myocardial infa rct ion , stroke , and sudden death attributed to coronary artery disease . RESULTS The mean total homocysteine level was lowered by 27 percent among patients given folic acid plus vitamin B12 , but such treatment had no significant effect on the primary end point ( risk ratio , 1.08 ; 95 percent confidence interval , 0.93 to 1.25 ; P=0.31 ) . Also , treatment with vitamin B6 was not associated with any significant benefit with regard to the primary end point ( relative risk of the primary end point , 1.14 ; 95 percent confidence interval , 0.98 to 1.32 ; P=0.09 ) . In the group given folic acid , vitamin B12 , and vitamin B6 , there was a trend toward an increased risk ( relative risk , 1.22 ; 95 percent confidence interval , 1.00 to 1.50 ; P=0.05 ) . CONCLUSIONS Treatment with B vitamins did not lower the risk of recurrent cardiovascular disease after acute myocardial infa rct ion . A harmful effect from combined B vitamin treatment was suggested . Such treatment should therefore not be recommended . ( Clinical Trials.gov number , NCT00266487 . ) OBJECTIVE To study the effect of vitamin B on treatment of hyperhomocysteinemia and endothelial dysfunction in renal-transplant recipients . METHODS Thirty-six stable hyperhomocysteinemic renal-transplant recipients were r and omly assigned to vitamin treatment ( group A , n = 18 , folic acid 5 mg/d , vitamin B(6 ) 50 mg/d , B(12 ) 1000 microg/d ) or controlled group ( group B , n = 18 ) for 6 months . All subjects underwent assessment of levels for creatinine , creatinine clearance , average pressure , total cholesterol , triglyceride and fasting homocysteine . Endothelial function was evaluated using high-resolution vascular ultrasound . RESULTS The levels of homocysteine markedly decreased in group A [ ( 13 + /- 4 ) micromol/L vs ( 20 + /- 5 ) micromol/L , t = 5.3 , P < 0.01 ] after treatment , whereas no significant changes were observed in group B. In group A , endothelium dependent [ ( 12 + /- 5)% vs ( 9 + /- 5)% , t = 2.9 , P < 0.01 ] and independent [ ( 18 + /- 4)% vs ( 12 + /- 5)% , t = 3.4 , P < 0.01 ] vasodilatation responses significantly increased after treatment , no significant changes were observed in group B. Endothelium dependent [ ( 9 + /- 6)% , t = 2.8 , P < 0.01 ] and independent [ ( 12 + /- 5)% , t = 3.5 , P < 0.01 ] vasodilatation responses of group A were significantly lower than that of group B after treatment . CONCLUSIONS Vitamin B supplementation can reduce the
Output:
| There is no current evidence to support the use of homocysteine lowering therapy for cardiovascular disease prevention in kidney transplant recipients |
MS212902 | ***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 Femoral nerve block ( FNB ) , a commonly used postoperative pain treatment after total knee arthroplasty ( TKA ) , reduces quadriceps muscle strength essential for mobilization . In contrast , adductor canal block ( ACB ) is predominately a sensory nerve block . We hypothesized that ACB preserves quadriceps muscle strength as compared with FNB ( primary end point ) in patients after TKA . Secondary end points were effects on morphine consumption , pain , adductor muscle strength , morphine-related complications , and mobilization ability . Methods We performed a double-blind , r and omized , controlled study of patients scheduled for TKA with spinal anesthesia . The patients were r and omized to receive either a continuous ACB or an FNB via a catheter ( 30-mL 0.5 % ropivacaine given initially , followed by a continuous infusion of 0.2 % ropivacaine , 8 mL/h for 24 hours ) . Muscle strength was assessed with a h and held dynamometer , and we used the percentile change from baseline for comparisons . The trial was registered at clinical trials.gov ( Identifier : NCT01470391 ) . Results We enrolled 54 patients , of which 48 were analyzed . Quadriceps strength as a percentage of baseline was significantly higher in the ACB group compared with the FNB group : ( median [ range ] ) 52 % [ 31–71 ] versus 18 % [ 4–48 ] , ( 95 % confidence interval , 8–41 ; P = 0.004 ) . There was no difference between the groups regarding morphine consumption ( P = 0.94 ) , pain at rest ( P = 0.21 ) , pain during flexion of the knee ( P = 0.16 ) , or adductor muscle strength ( P = 0.39 ) ; neither was there a difference in morphine-related adverse effects or mobilization ability ( P > 0.05 ) . Conclusions Adductor canal block preserved quadriceps muscle strength better than FNB , without a significant difference in postoperative pain Purpose Providing effective analgesia for total knee arthroplasty ( TKA ) patients remains challenging . Femoral nerve block ( FNB ) offers targeted pain control ; however , its effect on motor function , related fall risk and impact on rehabilitation has been the source of controversy . Adductor canal block ( ACB ) potentially spares motor fibres of the femoral nerve , but the comparative effect of the two approaches has not yet been well defined due to considerable variability in pain perception . Our study compares both single-shot FNB and ACB , side to side , in the same patients undergoing bilateral TKA . Methods Sixty patients scheduled for bilateral TKA were r and omised to receive ultrasound-guided FNB on one leg and ACB on the other , in addition to combined spinal epidural anaesthesia . The primary outcome was comparative postoperative pain in either extremity at six to eight , 24 and 48 hours postoperatively . Secondary comparative outcomes included motor strength ( manually and via dynamometer ) , physical therapy milestones and patient satisfaction . Results While pain levels were lowest at six to eight hours postoperatively and increased thereafter ( P < 0.001 ) , no significant differences were seen between extremities at any time point with regard to pain in the quantitative comparison using visual analogue scale ( VAS ) scores ( P = 0.4154 ) , motor strength ( P = 0.7548 ) , physical therapy milestones or patient satisfaction . However , in the qualitative comparison , a significant proportion of patients reported the leg receiving ACB to be more painful than that receiving FNB at 24 h [ 50.9 % ( n = 30 ) vs 25.42 % ( n = 15 ) , P = 0.0168 ) ] . Conclusions Although we could not confirm a benefit in motor function between ACB and FNB , given the equivalent analgesic potency combined with its potentially lower overall impact if neuropraxia should occur , ACB may represent an attractive alternative to FNB Background There are several methods for postoperative analgesia for knee surgery . The commonly utilized method is multimodal analgesia based on continuous femoral nerve block . The aim of this study was to investigate the application of continuous adductor canal block for analgesia after total knee replacement and compare this method with continuous femoral nerve block . Methods Sixty patients scheduled for total knee replacement from June 2013 to March 2014 were r and omly divided into a femoral group and an adductor group . Catheters were placed under the guidance of nerve stimulation in the femoral group and under the guidance of ultrasound in the adductor group . Operations were performed under combined spinal and epidural anesthesia . After the operations , 0.2 % ropivacaine was given at a speed of 5 ml/h through catheters in all patients . Visual analogue scale ( VAS ) pain scores at rest and while moving were noted at 4 , 24 , and 48 hours after the operation , and quadriceps strength was also assessed at these time‐points . Secondary parameters such as doses of complementary analgesics and side effects were also recorded . Results There were no significant differences between the groups in VAS pain scores at rest or while moving , at 4 , 24 , or 48 hours after the operation ( P > 0.05 ) . At these time‐points , mean quadriceps strengths in the adductor group were 3.0 ( 2.75‐3.0 ) , 3.0 ( 3.0‐4.0 ) , and 4.0 ( 3.0‐4.0 ) , respectively , all of which were significantly stronger than the corresponding means in the femoral group , which were 2.0 ( 2.0‐3.0 ) , 2.0 ( 2.0‐3.0 ) , and 3.0 ( 2.0‐4.0 ) , respectively ( P < 0.05 ) . There were no significant differences between the groups in doses of complementary analgesics or side effects ( P > 0.05 ) . X‐ray images of some patients showed that local anesthetic administered into the adductor canal could diffuse upward and reach the femoral triangle . Conclusions Continuous adductor canal block with 0.2 % ropivacaine could be used effectively for analgesia after total knee replacement . Compared with continuous femoral nerve block , this analgesic method has similar analgesic effects and is associated with less weakness of quadriceps muscle Background : This prospect i ve double-blinded , r and omized controlled trial compared adductor canal block ( ACB ) with femoral nerve block ( FNB ) in patients undergoing total knee arthroplasty . The authors hypothesized that ACB , compared with FNB , would exhibit less quadriceps weakness and demonstrate noninferior pain score and opioid consumption at 6 to 8 h postanesthesia . Methods : Patients received an ACB or FNB as a component of a multimodal analgesic . Quadriceps strength , pain score , and opioid consumption were assessed on both legs preoperatively and at 6 to 8 , 24 , and 48 h postanesthesia administration . In a joint hypothesis test , noninferiority was first evaluated on the primary outcomes of strength , pain score , and opioid consumption at 6 to 8 h ; superiority on each outcome at 6 to 8 h was then assessed only if noninferiority was established . Results : Forty-six patients received ACB ; 47 patients received FNB . At 6 to 8 h postanesthesia , ACB patients had significantly higher median dynamometer readings versus FNB patients ( median [ interquartile range ] , 6.1 kgf [ 3.5 , 10.9 ] ( ACB ) vs. 0 kgf [ 0.0 , 3.9 ] ( FNB ) ; P < 0.0001 ) , but was not inferior to FNB with regard to Numeric Rating Scale pain scores ( 1.0 [ 0.0 , 3.5 ] ACB vs. 0.0 [ 0.0 , 1.0 ] FNB ; P = 0.019 ) , or to opioid consumption ( 32.2 [ 22.4 , 47.5 ] ACB vs. 26.6 [ 19.6 , 49.0 ] ; P = 0.0115 ) . At 24 and 48 h postanesthesia , there was no significant statistical difference in dynamometer results , pain scores , or opioid use between the two groups . Conclusion : At 6 to 8 h postanesthesia , the ACB , compared with the FNB , exhibited early relative sparing of quadriceps strength and was not inferior in both providing analgesia or opioid intake Total knee replacement ( TKR ) produces severe postoperative pain . Peripheral nerve blocks can be used as analgesic adjuncts for TKR , but the efficacy of femoral nerve blocks alone is controversial . The sciatic nerve innervates posterior regions of the knee ; thus , performance of both sciatic and femoral nerve blocks may be necessary to improve analgesia after TKR . We performed this study to determine whether peripheral nerve blocks improve analgesia after TKR . In a r and omized , double-blind fashion , 36 patients undergoing TKR received either femoral , sciatic-femoral , or sham nerve blocks after a st and ardized spinal anesthetic . Further postoperative analgesia was provided by patient-controlled IV morphine and ketorolac . Pain at rest and with physical therapy , morphine use , nausea , pruritus , sedation , and patient satisfaction were assessed . Patients receiving peripheral nerve blocks reported better analgesia at rest for at least 8 h after transfer to the hospital ward ( P < 0.05 ) . Morphine use was decreased by approximately 50 % in the peripheral nerve block groups until the second postoperative day ( P < 0.02 ) . Side effect profiles and patient satisfaction were similar between groups . We conclude that femoral nerve blocks improve analgesia and decrease morphine use after TKR . The addition of a sciatic nerve block to the femoral nerve block did not further improve analgesic efficacy . Implication s : Performance of femoral nerve blocks improves analgesia and decreases the need for morphine after total knee replacement surgery . The addition of a sciatic nerve block to the femoral nerve block does not provide additional benefits . ( Anesth Analg 1998;87:93 - 7 Background and Objectives Adductor canal block ( ACB ) has been suggested as an analgesic alternative to femoral nerve block ( FNB ) for procedures on the knee , but its effect on quadriceps motor function is unclear . We performed a r and omized , blinded study to compare quadriceps strength following adductor canal versus FNB in volunteers . Our hypothesis was that quadriceps strength would be preserved following ACB , but not FNB . Secondary outcomes included relative preservation of hip adduction and degree of balance impairment . Methods The ACB was performed in one leg and the FNB in the contralateral leg in 16 volunteers using a r and omized block sequence . For all blocks , 15 mL of 3 % chloroprocaine was injected under ultrasonographic guidance . Maximal voluntary isometric contraction of knee extension and hip adduction was measured at baseline and at 30 and 60 minutes after block . After 60-minute assessment s were complete , the second block was placed . A test of balance ( Berg Balance Scale ) was performed 30 minutes after the first block only . Results Quadriceps strength and balance scores were similar to baseline following ACB . Following FNB , there was a significant reduction in quadriceps strength ( 95.1 % ± 17.1 % vs 11.1 % ± 14.0 % ; P < 0.0001 ) and balance scores ( 56 ± 0 vs 37 ± 17.2 ; P = 0.02 ) compared with baseline . There was no difference in hip adductor strength ( 97.0 % ± 10.8 % vs 91.8 % ± 9.6 % ; P = 0.17 ) . Conclusions Compared with FNB , ACB results in significant quadriceps motor sparing and significantly preserved balance Background : Whether decreasing the local anesthetic concentration during a continuous femoral nerve block results in less quadriceps weakness remains unknown . Methods : Preoperatively , bilateral femoral perineural catheters were inserted in subjects undergoing bilateral knee arthroplasty ( n = 36 ) at a single clinical center . Postoperatively , right-sided catheters were r and omly assigned to receive perineural ropivacaine of either 0.1 % ( basal 12 ml/h ; bolus 4 ml ) or 0.4 % ( basal 3 ml/h ; bolus 1 ml ) , with the left catheter receiving the alternative concentration/rate in an observer- and subject-masked fashion . The primary endpoint was the maximum voluntary isometric contraction of the quadriceps femoris muscles the morning of postoperative day 2 . Equivalence of treatments would be concluded if the 95 % CI for the difference fell within the interval −20%–20 % . Secondary endpoints included active knee extension , passive knee flexion , tolerance to cutaneous electrical current applied over the distal quadriceps tendon , dynamic pain scores , opioid requirements , and ropivacaine consumption . Results : Quadriceps maximum voluntary isometric contraction for limbs receiving 0.1 % ropivacaine was a mean ( SD ) of 13 ( 8) N · m , versus 12 ( 8) N · m for limbs receiving 0.4 % [ intrasubject difference of 3 ( 40 ) percentage points ; 95 % CI −10–17 ; P = 0.63 ] . Because the 95 % CI fell within prespecified tolerances , we conclude that the effect of the two concentrations were equivalent . Similarly , there were no statistically significant differences in secondary endpoints .
Output:
| Conclusions The present study suggests that TKA patients who receive ACB can achieve similar or even better recovery of quadriceps strength and mobilization ability than those treated with FNB .
Taken as a whole , ACB may be a better analgesia strategy after TKA at present |
MS212903 | ***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: Hyperinsulinemia may explain excess colorectal cancer among individuals who are overweight or inactive . Recent studies have observed elevated colorectal cancer risk among individuals with elevated insulin levels 2 hours after oral glucose challenge or with elevated plasma C-peptide levels . The effect of consuming a high glycemic diet on colorectal risk , however , remains uncertain . Two prospect i ve cohort studies , the Nurses ' Health Study and the Health Professionals Follow-up Study , contributed up to 20 years of follow-up . After exclusions , 1,809 incident colorectal cancers were available for analyses . Dietary glycemic load ( GL ) was calculated as a function of glycemic index ( postpr and ial blood glucose response as compared with a reference food ) , carbohydrate content , and frequency of intake of individual foods reported on food frequency question naires . Multivariable Cox proportional hazards models were used to adjust for potential confounders . Intakes of dietary carbohydrate , GL , overall glycemic index , sucrose , and fructose were not associated with colorectal cancer risk in women . A small increase in risk was observed in men with high dietary GL ( multivariate relative risk , 1.32 ; 95 % confidence interval , 0.98 - 1.79 ; highest versus lowest quintile ) , sucrose or fructose ( multivariate relative risk , 1.37 ; 95 % confidence interval , 1.05 - 1.78 ; highest versus lowest quintile of fructose , P = 0.008 ) . Associations were slightly stronger among men with elevated body mass index ( > or = 25 kg/m(2 ) ) . Results among women were similar after stratifying by body mass index or physical activity . High intakes of GL , fructose , and sucrose were related to an elevated colorectal cancer risk among men . For women , however , these factors did not seem to increase the risk of colorectal cancer OBJECTIVE To examine associations between type 2 diabetes and fiber , glycemic load ( GL ) , dietary glycemic index ( GI ) , and fiber-rich foods . RESEARCH DESIGN AND METHODS This was a prospect i ve study of 36,787 men and women aged 40 - 69 years without diabetes . For all self-reported cases of diabetes at 4-year follow-up , confirmation of diagnosis was sought from medical practitioners . Case subjects were those who reported diabetes at follow-up and for whom there was no evidence that they did not have type 2 diabetes . Data were analyzed with logistic regression , adjusting for country of birth , physical activity , family history of diabetes , alcohol and energy intake , education , 5-year weight change , sex , and age . RESULTS Follow-up was completed by 31,641 ( 86 % ) participants , and 365 cases were identified . The odds ratio ( OR ) for the highest quartile of white bread intake compared with the lowest was 1.37 ( 95 % CI 1.04 - 1.81 ; P for trend = 0.001 ) . Intakes of carbohydrate ( OR per 200 g/day 0.58 , 0.36 - 0.95 ) , sugars ( OR per 100 g/day 0.61 , 0.47 - 0.79 ) , and magnesium ( OR per 500 mg/day 0.62 , 0.43 - 0.90 ) were inversely associated with incidence of diabetes , whereas intake of starch ( OR per 100 g/day 1.47 , 1.06 - 2.05 ) and dietary GI ( OR per 10 units 1.32 , 1.05 - 1.66 ) were positively associated with diabetes . These relationships were attenuated after adjustment for BMI and waist-to-hip ratio . CONCLUSIONS Reducing dietary GI while maintaining a high carbohydrate intake may reduce the risk of type 2 diabetes . One way to achieve this would be to substitute white bread with low-GI breads BACKGROUND Little is known about the effects of the amount and type of carbohydrates on risk of coronary heart disease ( CHD ) . OBJECTIVE The objective of this study was to prospect ively evaluate the relations of the amount and type of carbohydrates with risk of CHD . DESIGN A cohort of 75521 women aged 38 - 63 y with no previous diagnosis of diabetes mellitus , myocardial infa rct ion , angina , stroke , or other cardiovascular diseases in 1984 was followed for 10 y. Each participant 's dietary glycemic load was calculated as a function of glycemic index , carbohydrate content , and frequency of intake of individual foods reported on a vali date d food-frequency question naire at baseline . All dietary variables were up date d in 1986 and 1990 . RESULTS During 10 y of follow-up ( 729472 person-years ) , 761 cases of CHD ( 208 fatal and 553 nonfatal ) were documented . Dietary glycemic load was directly associated with risk of CHD after adjustment for age , smoking status , total energy intake , and other coronary disease risk factors . The relative risks from the lowest to highest quintiles of glycemic load were 1.00 , 1.01 , 1 . 25 , 1.51 , and 1.98 ( 95 % CI : 1.41 , 2.77 for the highest quintile ; P for trend < 0.0001 ) . Carbohydrate classified by glycemic index , as opposed to its traditional classification as either simple or complex , was a better predictor of CHD risk . The association between dietary glycemic load and CHD risk was most evident among women with body weights above average ¿ ie , body mass index ( in kg/m(2 ) ) > /= 23 . CONCLUSION These epidemiologic data suggest that a high dietary glycemic load from refined carbohydrates increases the risk of CHD , independent of known coronary disease risk factors BACKGROUND Dietary carbohydrates may influence the development of type 2 ( non-insulin-dependent ) diabetes , for example , through effects on blood glucose and insulin concentrations . OBJECTIVE We examined the relations of baseline intake of carbohydrates , dietary fiber , dietary magnesium , and carbohydrate-rich foods and the glycemic index with incidence of diabetes . DESIGN This was a prospect i ve cohort study of 35988 older Iowa women initially free of diabetes . During 6 y of follow-up , 1141 incident cases of diabetes were reported . RESULTS Total grain , whole-grain , total dietary fiber , cereal fiber , and dietary magnesium intakes showed strong inverse associations with incidence of diabetes after adjustment for potential nondietary confounding variables . Multivariate-adjusted relative risks of diabetes were 1.0 , 0.99 , 0.98 , 0.92 , and 0.79 ( P for trend : 0.0089 ) across quintiles of whole-grain intake ; 1.0 , 1.09 , 1.00 , 0.94 , and 0.78 ( P for trend : 0.005 ) across quintiles of total dietary fiber intake ; and 1.0 , 0.81 , 0.82 , 0.81 , and 0.67 ( P for trend : 0.0003 ) across quintiles of dietary magnesium intake . Intakes of total carbohydrates , refined grains , fruit and vegetables , and soluble fiber and the glycemic index were unrelated to diabetes risk . CONCLUSION These data support a protective role for grains ( particularly whole grains ) , cereal fiber , and dietary magnesium in the development of diabetes in older women BACKGROUND Metabolism of many of the most commonly consumed carbohydrates in the United States results in a high plasma glucose response , which can be quantified by the glycemic load . Although hyperglycemia is a risk factor for cataract , there is no information on the potential effect of a high dietary glycemic load on the incidence of age-related cataract . OBJECTIVE Our objective was to prospect ively examine the association between dietary glycemic load and incident age-related cataract . DESIGN We studied 2 cohorts-71 919 women and 39 926 men-aged > or = 45 y who had no previous diagnosis of cataract , diabetes mellitus , or cancer and who were followed for 14 and 12 y , respectively , for the occurrence of cataract extraction . We calculated dietary glycemic load from data reported on multiple vali date d food-frequency question naires and used pooled logistic regression models to estimate the association with incident cataract extraction . We performed analyses separately for each cohort and then calculated pooled estimates across cohorts . RESULTS During 980 683 person-years of follow-up , we confirmed 4865 incident age-related cataract extraction s. After adjustment for age , cigarette smoking , body mass index , total caloric intake , dietary intake of lutein and zeaxanthin , and alcohol consumption , there was no significant relation of dietary glycemic load to risk of cataract extraction ( P for trend = 0.10 ) . The pooled relative risk between the highest and lowest quintiles of dietary glycemic load was 0.95 ( 95 % CI : 0.81 , 1.11 ; P for heterogeneity by cohort = 0.1 ) . CONCLUSION These prospect i ve epidemiologic data do not support the hypothesis that a high dietary glycemic load , primarily a result of consumption of refined carbohydrates , increases the risk of cataract extraction BACKGROUND Reducing the glycemic load ( GL ) is considered beneficial for managing insulin resistance . The GL can be reduced either by reducing carbohydrate intake or by reducing the glycemic index ( GI ) . OBJECTIVE We studied whether these 2 dietary maneuvers have the same long-term effects on postpr and ial plasma glucose , insulin , triacylglycerol , and free fatty acid ( FFA ) concentrations in subjects with impaired glucose tolerance ( IGT ) . DESIGN Thirty-four subjects with IGT were r and omly assigned to high-carbohydrate , high-GI ( high-GI ) ; high-carbohydrate , low-GI ( low-GI ) ; and low-carbohydrate , high-monounsaturated fatty acid ( MUFA ) diets for 4 mo . Plasma glucose , insulin , and FFAs were measured from 0800 to 1600 at baseline in response to high-GI meals ( 60 % carbohydrate , GI = 61 , GL = 63 ) and after 4 mo in response to meals representative of the study diet . RESULTS Carbohydrate intake ( % of energy ) , GI , and GL in the high-GI , low-GI , and MUFA groups ( breakfast and lunch meals combined ) , respectively , were 60 % , 61 , and 63 ; 60 % , 53 , and 55 ; and 49 % , 61 , and 52 . Compared with the change after 4 mo of the high-GI diet , both the low-GI and MUFA diets reduced 0 - 8-h mean plasma glucose concentrations by 0.35 mmol/L ( P < 0.05 ) . Mean plasma insulin was approximately 20 % higher ( P < 0.05 ) and FFAs approximately 12 % lower ( P < 0.05 ) after the low-GI diet than after the high-GI diet , with no significant effect of MUFA . Changes in 0 - 8-h mean plasma triacylglycerols in the 3 treatment groups differed significantly : -0.14 , 0.04 , and 0.18 mmol/L , respectively , with the high-GI , MUFA , and low-GI diets . CONCLUSIONS In subjects with IGT , reducing the GI of the diet for 4 mo reduced postpr and ial plasma glucose by the same amount as did reducing carbohydrate intake . The 2 dietary maneuvers had different effects on postpr and ial plasma insulin , triacylglycerols , and FFAs BACKGROUND Increasing evidence suggests an important role of carbohydrate quality in the development of type 2 diabetes . OBJECTIVE Our objective was to prospect ively examine the association between glycemic index , glycemic load , and dietary fiber and the risk of type 2 diabetes in a large cohort of young women . DESIGN In 1991 , 91249 women completed a semiquantitative food-frequency question naire that assessed dietary intake . The women were followed for 8 y for the development of incident type 2 diabetes , and dietary information was up date d in 1995 . RESULTS We identified 741 incident cases of confirmed type 2 diabetes during 8 y ( 716 300 person-years ) of follow-up . After adjustment for age , body mass index , family history of diabetes , and other potential confounders
Output:
| Low-GI and /or low-GL diets are independently associated with a reduced risk of certain chronic diseases .
In diabetes and heart disease , the protection is comparable with that seen for whole grain and high fiber intakes .
The findings support the hypothesis that higher postpr and ial glycemia is a universal mechanism for disease progression |
MS212904 | ***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 aim of this study was to evaluate the effectiveness of granulocyte-macrophage colony-stimulating factor ( GM-CSF ) mouthwashes in the prevention of severe mucositis induced by high doses of chemotherapy . PATIENTS AND METHODS Ninety consecutive patients affected by solid tumors and undergoing high-dose chemotherapy with autologous peripheral blood stem cell transplantation rescue were r and omized to receive placebo versus GM-CSF mouthwash 150 micro g/day . Patients were stratified on the basis of the conditioning treatment and the consequent different risk of severe oral mucositis . Treatment was administered from the day after the end of chemotherapy until the resolution of stomatitis and /or neutrophil recovery . RESULTS The statistical analyses were intention-to-treat and involved all patients who entered the study . The severity of stomatitis was evaluated daily by the physicians according to National Cancer Institute Common Toxicity Criteria . Both study and control groups were compared with respect to the frequency [ 30 % versus 36 % , chi(2 ) exact test , not significant ( NS ) ] and mean duration ( 4.8 + /- 4.7 versus 4.4 + /- 2.7 days , t-test , NS ) of severe stomatitis ( grade > or = 3 ) . Oral pain was evaluated daily by patients themselves by means of a 10 cm analog visual scale : the mean ( + /- st and ard error of the mean ) maximum mucositis scores were 4.8 + /- 3.5 versus 4.2 + /- 3.5 cm ( t-test , NS ) . Furthermore , 15/46 patients in the study group ( 33 % ) and 19/44 patients in the control group experienced pain requiring opioids ( chi(2 ) exact test , NS ) . CONCLUSION We did not find any evidence to indicate that prophylaxis with GM-CSF mouthwash can help to reduce the severity of mucositis in the setting of the patients we studied PURPOSE To compare granulocyte-macrophage colony-stimulating factor ( GM-CSF ) mouthwashes with sucralfate mouthwashes in the prevention of radiation-induced mucositis . METHODS AND MATERIAL S Forty patients with radically operated head- and -neck cancer were r and omly allocated to use either GM-CSF ( n = 21 ) or sucralfate ( n = 19 ) mouthwashes during postoperative radiotherapy ( RT ) . All patients received conventionally fractionated RT to a total dose of 50 - 60 Gy in 2-Gy daily fractions during 5 - 6 weeks to the primary site and regional lymphatics . A minimum of 50 % of the oral cavity and oropharyngeal mucosa was included in the clinical target volume . GM-CSF mouthwashes consisted of 37.5 microg GM-CSF and sucralfate mouthwashes of 1.0 g of sucralfate distilled in water . Both washes were used 4 times daily , beginning after the first week of RT and continued to the end of the RT course . Symptoms related to radiation mucositis and body weight , serum prealbumin level , and blood cell counts were monitored weekly . RESULTS Oral mucositis tended to be less severe in the GM-CSF group ( p = 0.072 ) . Complete ( n = 1 ) or partial ( n = 4 ) healing of mucositis occurred during the RT course in 5 patients ( 24 % ) in the GM-CSF group and in none of the patients in the sucralfate group ( p = 0.049 ) . Patients who received GM-CSF had less mucosal pain ( p = 0.058 ) and were less often prescribed opioids for pain ( p = 0.042 ) . Three patients in the sucralfate group needed hospitalization for mucositis during RT compared with none in the GM-CSF group . Four patients ( 21 % ) in the sucralfate group and none in the GM-CSF group required an interruption in the RT course ( p = 0.042 ) . No significant differences in weight , prealbumin level , or blood cell count were found between the groups , and both mouthwashes were well tolerated . CONCLUSION GM-CSF mouthwashes may be moderately more effective than sucralfate mouthwashes in preventing radiation-induced mucositis and mucositis-related pain , and their use may lead to less frequent RT course interruptions from mucositis . The present findings need to be confirmed before adopting GM-CSF mouthwashes in routine clinical use BACKGROUND Mucositis is one of the most frequent and severe side-effect of chemotherapy in childhood-cancer patients for which there is no prophylaxis available . The efficacy and feasibility of a TGF-beta(2)-enriched feeding for preventing oral and gastro-intestinal-mucositis in childhood-cancer patients were studied . PROCEDURE The study was design ed as a two-period cross-over , r and omized , double-blinded , placebo , controlled trial . Patients who had a high risk for developing mucositis and who would receive two comparable cycles of chemotherapy were eligible for the study . During one cycle of chemotherapy , TGF-beta(2)-enriched feeding was administered ; during the other , a " placebo " ( not enriched ) feeding was used . WHO toxicity scales of diarrhea , oral mucositis , fever , anal lesions and nausea/vomiting were scored daily . In addition , the incidence of occurrence of blood cultures , antibiotic therapy , and interventions or diagnostics related to mucositis were measured . RESULTS The feasibility of the study was good : 83 % of the patients completed two cycles and 86 % of the study -feeding was effectively consumed . Administration of TGF-beta(2 ) was safe as serum TGF-beta(2 ) did not increase , and renal and liver function were not affected during TGF-beta(2 ) consumption compared to normal feeding . Differences in toxicity , scored during the whole observation period and the number of days with WHO 3/4 toxicity , were not significantly different between cycles with TGF-beta(2 ) enriched and normal feeding . CONCLUSIONS TGF-beta(2 ) administration via feeding is well tolerated and safe . Although this study might have had limitations to show potential benefit of TGF-beta(2 ) , it does not provide evidence that TGF-beta(2 ) decreases the incidence or degree of mucositis induced by combination chemotherapy in childhood-cancer patients Conditioning therapy in connection with haematopoietic SCT ( HSCT ) induces a disruption of the intestinal barrier function facilitating the permeation of bacteria and endotoxin through the bowel wall with subsequent increased risk of septicaemia and a worsening of GVHD in the allogeneic setting . Palifermin ( recombinant human keratinocyte growth factor ) reduces the severity of oral mucositis with HSCT . The present trial investigates its effect on intestinal barrier function . Seventeen lymphoma patients undergoing autologous HSCT received palifermin . Intestinal permeability was assessed before the conditioning therapy and on days + 4 and + 14 . Clinical oral and gastrointestinal toxicity was prospect ively assessed in parallel . A comparison was made with matched historical study patients ( n=21 ) . Patients treated with palifermin had a significantly better preserved intestinal barrier function ( P=0.01 on day + 4 ) and were in less need of total parenteral nutrition ( P=0.005 ) as compared with controls . No significant reduction of clinical gastrointestinal or oral toxicity was observed . The intestinal barrier function , normally disrupted by the conditioning therapy , is preserved by palifermin . Whether intestinal barrier preservation protects from invasive infections , and in the allogeneic setting diminishes GVHD severity , remains to be investigated in r and omized controlled trials Oral mucositis is a frequent side effect of myeloablative chemo- and radiotherapy preceding stem cell transplantation . It causes pain , poor food intake , and is a port of entry for infection . We studied whether GM-CSF applied topically in the oral cavity can prevent or ameliorate this mucositis . In 36 consecutive patients undergoing a stem cell transplantation , we performed a double-blind placebo-controlled study of 300 µg GM-CSF in a 2 % methylcellulose gel daily versus a 2 % methylcellulose gel alone . Both were locally applied in the oral cavity . The primary end-point was mucositis as measured by the WHO toxicity scale for mucositis , oral assessment scale , and a subjective pain scale , all scored daily . The secondary end-points were need to give parenteral nutrition and morphine , incidence of fever and infections , and duration of neutropenia and hospitalization . No differences were found in the median subjective pain scores , WHO scores , and oral assessment scores between the placebo and the GM-CSF groups . In both groups , nine patients required morphine for pain control . Ten patients in the placebo group and 11 in the GM-CSF group received parenteral nutrition . Documented infections , use of broad-spectrum antibiotics , and number of days with fever were similar in the placebo and the GM-CSF groups . The duration of neutropenia below 0.5 × 109/l ( median 14.5 days in the placebo group versus 17 days in the GM-CSF group ) and the duration of hospitalization ( 28.5 versus 29 days ) was also not significantly different . We found no beneficial effect of 300 µg GM-CSF dissolved in a 2 % methylcellulose gel applied locally for chemo- and radiotherapy-induced mucositis in patients undergoing a stem cell transplantation PURPOSE Oral mucositis ( OM ) is one of the most debilitating and common side effects in patients treated with high-dose chemotherapy supported by haematopoietic stem cell transplantation ( HSCT ) . We tested the effectiveness of palifermin to avoid oral mucosal injury induced by the conditioning regimen . PATIENTS AND METHODS Twenty patients with haematological malignancies were treated with palifermin for prevention of OM during HSCT procedures . Nine patients received allogeneic haematopoietic stem cells , and in 11 autologous HSCT was performed . The control group was composed of patients who had been treated with HSCT previously , before the palifermin era . The source of graft was peripheral blood . RESULTS Among patients treated with palifermin no grade 2 - 4 OM was observed . No patient had to receive opioid analgesics or total parenteral nutrition . 30 % of the patients developed grade 1 OM of 4 - 5 days ' duration . In the control group OM was observed in all cases , with 50 % of the patients developing grade 3 - 4 OM . Median duration of OM was 10 and 12 days for auto- and allogeneic patients , respectively . In comparison with the control group , treatment with palifermin was associated with significant reduction of grade 2 - 4 OM , shorter duration of OM , less analgesics intake , and reduced number of days with antibiotic treatment . Additionally , allogeneic patients treated with palifermin had shorter time to platelet engraftment . CONCLUSION Palifermin reduces incidence , severity and duration of OM , and decreases the number of days with analgesics and antibiotics . For allogeneic patients it can shorten the time to platelet engraftment , but this observation needs further studies ATL-104 is a potent mitogen for epithelial cells of the gastrointestinal tract . In animal models , ATL-104 aids regeneration of the gastrointestinal tract after treatment with chemotherapeutic agents . The effect of ATL-104 on mucositis in patients requiring high-dose melphalan or BEAM before peripheral blood SCT ( PBSCT ) was investigated in a r and omized , placebo-controlled , double-blind , two-part study . Patients were r and omized to ATL-104 ( 50 , 100 or 150 mg ) or placebo once daily for 3 days before chemotherapy and 3 days after PBSCT . Part one of the study was a dose-escalation design ; part two was a parallel group design using all three ATL-104 doses . Patients were followed up for 28 days post-treatment . Severity of signs and symptoms were assessed and used to calculate scores for st and ard toxicity rating scales ( WHO , Western Consortium for Cancer Nursing Research ( WCCNR ) ) . Sixty-three patients were treated . Treatment with ATL-104 substantially reduced the median duration of severe oral mucositis ( WHO grade 3 or 4 ) compared with placebo ( median duration : ATL-104 groups 2 or 3 days , placebo 10.5 days ) . The effect of ATL-104 on the incidence of severe oral mucositis was inconclusive . Similar results were obtained using the WCCNR Scale . Adverse events ( AEs ) were predominantly mild or moderate in intensity . Gastrointestinal AE were most common Goals of workThe objective of this study was to evaluate the safety and tolerability of velafermin in patients at risk of developing severe oral mucositis ( OM ) from chemotherapy . Material s and methods This study was a single-center , open-label , single-dose escalation , phase I trial in patients undergoing high-dose chemotherapy ( HDCT ) and autologous peripheral blood stem cell transplant ( PBSCT ) .
Output:
| Conclusions Of the cytokine and growth factor agents studied for oral mucositis , the evidence only supports use of palifermin in the specific population listed above . |
MS212905 | ***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 Reductions in postpr and ial glycemia have been demonstrated previously with the addition of the novel viscous polysaccharide ( NVP ) , PolyGlycopleX ® ( PGX ® ) , to an OGTT or white bread . This study explores whether these reductions are sustained when NVP is added to a range of commonly consumed foods or incorporated into a breakfast cereal . Methods Ten healthy subjects ( 4 M , 6F ; age 37.3 ± 3.6 y ; BMI 23.8 ± 1.3 kg/m2 ) , participated in an acute , r and omized controlled trial . The glycemic response to cornflakes , rice , yogurt , and a frozen dinner with and without 5 g of NVP sprinkled onto the food was determined . In addition , 3 granolas with different levels of NVP and 3 control white breads and one white bread and milk were also consumed . All meals contained 50 g of available carbohydrate . Capillary blood sample s were taken fasting and at 15 , 30 , 45 , 60 , 90 and 120 min after the start of the meal . The glycemic index ( GI ) and the glycemic reduction index potential ( GRIP ) were calculated . The blood glucose concentrations at each time and the iAUC values were subjected to repeated- measures analysis of variance ( ANOVA ) examining for the effect of test meal . After demonstration of significant heterogeneity , differences between individual means was assessed using GLM ANOVA with Tukey test to adjust for multiple comparisons . Results Addition of NVP reduced blood glucose response irrespective of food or dose ( p < 0.01 ) . The GI of cornflakes , cornflakes+NVP , rice , rice+NVP , yogurt , yogurt+NVP , turkey dinner , and turkey dinner+NVP were 83 ± 8 , 58 ± 7 , 82 ± 8 , 45 ± 4 , 44 ± 4 , 38 ± 3 , 55 ± 5 and 41 ± 4 , respectively . The GI of the control granola , and granolas with 2.5 and 5 g of NVP were 64 ± 6 , 33 ± 5 , and 22 ± 3 respectively . GRIP was 6.8 ± 0.9 units per/g of NVP . ConclusionS prinkling or incorporation of NVP into a variety of different foods is highly effective in reducing postpr and ial glycemia and lowering the GI of a food . Clinical Trial registration NCT00935350 Differences in glycemic responses to various starchy foods are related to differences in the rate of starch digestion and absorption . In this study , the importance of the degree of gelatinization and the product thickness for postpr and ial glycemic and insulinemic responses to rolled oats and barley were studied in healthy subjects ( 5 men and 5 women ) . Thick ( 1.0 mm ) rolled oats were made from raw or preheated ( roasted or steamed ) kernels . In addition , thin ( 0.5 mm ) rolled oats were made from roasted or roasted and steamed ( processed under conditions simulating commercial production ) oat kernels . Finally , steamed rolled barley kernels ( 0.5 or 1.0 mm ) were prepared . All thin flakes elicited high glucose and insulin responses [ glycemic index ( GI ) , 88 - 118 ; insulinemic index ( II ) , 84 - 102 ] , not significantly different from white wheat bread ( P : > 0.05 ) . In contrast , all varieties of thick oat flakes gave significantly lower metabolic responses ( GI , 70 - 78 ; II , 58 - 77 ) than the reference bread ( P : < 0.05 ) . Thick barley flakes , however , gave high glucose and insulin responses ( GI , 94 ; II , 84 ) , probably because the botanical structure underwent more destruction than the corresponding oat flakes . We conclude that minimal processing of oat and barley flakes had a relatively minor effect on GI features compared with the more extensive commercial processing . One exception was thick oat flakes , which in contrast to the corresponding barley flakes , had a low GI BACKGROUND Method ologic choices affect measures of the glycemic index ( GI ) . The effects on GI values of blood sampling site , reference food type , and the number of repeat tests have been insufficiently determined . OBJECTIVE The objective was to study the effect of method ologic choices on GI values . Comparisons were made between venous and capillary blood sampling and between glucose and white bread as the reference food . The number of tests needed for the reference food was assessed . Rye bread , oatmeal porridge , and instant mashed potato were used as the test foods . DESIGN Twelve healthy volunteers were served each test food once and both reference foods 3 times at 1-wk intervals in a r and om order after they had fasted overnight . Capillary and venous blood sample s were drawn at intervals for 3 h after each study meal . RESULTS GIs and their CVs based on capillary sample s were lower than those based on venous sample s. Two tests of glucose solution as the reference provided stable capillary GIs for the test foods . The capillary GIs did not differ significantly when white bread was used as the reference 1 , 2 , or 3 times , but the variation was lower when tests were performed 2 and 3 times . Capillary GIs with white bread as the reference were 1.3 times as high as those with glucose as the reference . The capillary GIs of rye bread , oatmeal porridge , and mashed potato were 77 , 74 , and 80 , respectively , with glucose as the reference . CONCLUSIONS Capillary blood sampling should be used in the measurement of GI , and reference tests with glucose or white bread should be performed at least twice Reliable tables of glycemic index ( GI ) compiled from the scientific literature are instrumental in improving the quality of research examining the relation between GI , glycemic load , and health . The GI has proven to be a more useful nutritional concept than is the chemical classification of carbohydrate ( as simple or complex , as sugars or starches , or as available or unavailable ) , permitting new insights into the relation between the physiologic effects of carbohydrate-rich foods and health . Several prospect i ve observational studies have shown that the chronic consumption of a diet with a high glycemic load ( GI x dietary carbohydrate content ) is independently associated with an increased risk of developing type 2 diabetes , cardiovascular disease , and certain cancers . This revised table contains almost 3 times the number of foods listed in the original table ( first published in this Journal in 1995 ) and contains nearly 1300 data entries derived from published and unpublished verified sources , representing > 750 different types of foods tested with the use of st and ard methods . The revised table also lists the glycemic load associated with the consumption of specified serving sizes of different foods The determine the effect of different foods on the blood glucose , 62 commonly eaten foods and sugars were fed individually to groups of 5 to 10 healthy fasting volunteers . Blood glucose levels were measured over 2 h , and expressed as a percentage of the area under the glucose response curve when the same amount of carbohydrate was taken as glucose . The largest rises were seen with vegetables ( 70 + /- 5 % ) , followed by breakfast cereals ( 65 + /- 5 % ) , cereals and biscuits ( 60 + /- 3 % ) , fruit ( 50 + /- 5 % ) , dairy products ( 35 + /- 1 % ) , and dried legumes ( 31 + /- 3 % ) . A significant negative relationship was seen between fat ( p less than 0.01 ) and protein ( p less than 0.001 ) and postpr and ial glucose rise but not with fiber or sugar content The primary aim of the present study was to exp and the glycaemic index ( GI ) data base by determining the GI and insulin index values of thirty-nine foods containing sugars in healthy adults . The second aim was to examine the hypothesis that glycaemic and insulin responses to foods which contain added sugar(s ) are higher than responses to foods containing naturally-occurring sugars . Eight healthy subjects drawn from a pool of eighteen consumed 50 g carbohydrate portions ( except 25 g carbohydrate portions for fruits ) of the test foods . The GI and insulin index were determined according to st and ardized methodology and expressed on a scale on which glucose = 100 . The median GI and insulin index values of all foods tested were 56 ( range 14 to 80 ) and 56 ( range 24 to 124 ) respectively . The median GI of the foods containing added sugars was similar to that of foods containing naturally-occurring sugars ( 58 v. 53 respectively , P = 0.08 ) . Likewise , the median insulin index of the foods containing added sugars was not significantly different from that of foods containing naturally-occurring sugars ( 61 v. 56 respectively , P = 0.16 ) . There was no evidence of ' rebound hypoglycaemia ' or excessive insulin secretion relative to the glucose response . We conclude that most foods containing sugars do not have a high GI . In addition , there is often no difference in responses between foods containing added sugars and those containing naturally-occurring sugars Objective : To determine the glycaemic index ( GI ) of various staple carbohydrate-rich foods in the UK diet , and to consider the factors influencing the GI of foods . Design : Subjects were served with 25 or 50 g portions of glucose on three occasions , followed by a selection of test foods providing an equal amount of available carbohydrate , in r and om order . Each test food was consumed by 10 subjects . Capillary blood glucose levels were measured in the fasted state and over the 120 min following commencement of consumption of the foods . Setting : The study was carried out in a research institute ( MRC Human Nutrition Research , Cambridge , UK).Subjects : Forty-two healthy adult volunteers were studied . Methods : The GI values of 33 foods were measured according to the WHO/FAO recommended methodology . These foods included various breads , breakfast cereals , pasta , rice and potatoes , all of which were commercially available in the UK . Conclusions : The results illustrate a number of factors which are important in influencing the GI of a food , highlighting the importance of measuring the GI of a food , rather than assuming a previously published value for a similar food . This is useful both to research ers analysing dietary surveys or planning intervention studies , and also to health professionals advising individuals on their diets AIM To determine the glycaemic index values to a range of foods that are unique to New Zeal and , and those that are grown and /or manufactured locally . METHODS We determined the glycaemic index of 28 carbohydrate foods in both healthy subjects and those with type 2 diabetes . Venous blood sample s were collected over two to three hours , and the incremental area under the blood glucose curve was used to calculate glycaemic index values . RESULTS AND CONCLUSIONS This study has identified the glycaemic index values for a range of New Zeal and foods which will be clinical ly useful in the nutritional management of individuals with diabetes mellitus . People with diabetes are recommended to choose foods with a low glycaemic index which is associated with optimal blood glucose control and lipid levels The effect of plasma glucose on satiety and the capacity of carbohydrates to stimulate cholecystokinin ( CCK ) remain unclear . The aim of this study was to test the hypothesis that the magnitude of the postpr and ial plasma glucose and insulin response is inversely related to the CCK response and to subjective satiety . Seven healthy , male volunteers consumed equal carbohydrate portions ( 0.5 g/kg body weight ) of six test meals ( Rice Bubbles , Sustain , Vita-Brits , All-Bran , porridge and white bread ) in r and om order after an overnight fast . An egg and bacon meal was consumed as a non-carbohydrate control providing 0.5 g protein/kg body weight . Serum CCK , plasma glucose and insulin and subjective satiety ( measured by a rating scale ) were assessed over 3 h and quantified using the glycaemic index ( GI ) , insulin index ( II ) , the peak satiety score and area under the incremental curve ( AUC ) . The observed GIs ( mean + /- SE ) ranged from 42.5 + /- 2.6 for All-Bran to 116.2 + /- 11.4 for Rice Bubbles , using white bread as the reference food ( GI = 100 ) . Peak satiety scores varied eightfold from 0.21 + /- 0.4 for Sustain to 1.64 + /- 0.4 for All-Bran . Significant inverse relationships were observed between the peak satiety score and both the glycaemic and insulin index of the seven meals ( r = -0.916 , p less than 0.001 and r = -0.926 , p less than 0.001 ) . A direct relationship was observed between satiety ( AUC ) and the CCK response ( AUC ) ( r = 0.73 p less than 0.01 ) . The results suggest that glycaemic and insulin responses to carbohydrate foods are inversely proportional to the CCK response and satiety The objective of the
Output:
| The analysis establishes that differences in processing protocol s and cooking practice s modify the glycaemic response to foods made with whole-grain oats .
Smaller particle size and increased starch gelatinisation appear to increase the glycaemic response |
MS212906 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: INTRODUCTION We explored the differential effect of cessation interventions ( behavioral support sessions with [ BSS+ ] and without [ BSS ] bupropion ) between hookah and cigarette smokers . METHODS We reanalyzed the data from a major cluster-r and omized controlled trial , ASSIST ( Action to Stop Smoking In Suspected Tuberculosis ) , which consisted of 3 conditions : ( a ) behavioral support sessions ( BSS ) , ( b ) behavioral support sessions plus 7 weeks of bupropion therapy ( BSS+ ) , and ( c ) controls receiving usual care . The trial originally recruited 1,955 adult smokers with suspected tuberculosis from 33 health centers in the Jhang and Sargodha districts of Pakistan between 2010 and 2011 . The primary endpoint was continuous 6-month smoking abstinence , which was determined by carbon monoxide levels . Subgroup-specific relative risks ( RRs ) of smoking abstinence were computed and tested for differential intervention effect using log binomial regression ( generalized linear model ) between 3 subgroups ( cigarette-only : 1,255 ; mixed : 485 ; and hookah-only : 215 ) . RESULTS The test result for homogeneity of intervention effects between the smoking forms was statistically significant ( p-value for BSS+ : .04 and for BSS : .02 ) . Compared to the control , both interventions appeared to be effective among hookah smokers ( RR = 2.5 ; 95 % CI = 1.3 - 4.7 and RR = 2.2 ; 95 % CI = 1.3 - 3.8 , respectively ) but less effective among cigarette smokers ( RR = 6.6 ; 95 % CI = 4.6 - 9.6 and RR = 5.8 ; 95 % CI = 4.0 - 8.5 ) , respectively . CONCLUSIONS The differential intervention effects on hookah and cigarette smokers were seen ( a ) because the behavioral support intervention was design ed primarily for cigarette smokers ; ( b ) because of differences in demographic characteristics , behavioral , and sociocultural determinants ; or ( c ) because of differences in nicotine dependency levels between the 2 groups Abstract Many cancer patients continue to smoke postdiagnosis , which is associated with poorer clinical outcomes . Identifying prospect i ve predictors of smoking cessation among patients currently receiving smoking cessation treatment can help guide the development and implementation of smoking cessation programs with this population . Material and methods . Data from 246 cancer patients participating in a r and omized placebo-controlled smoking cessation clinical trial were used to examine baseline predictors of end-of-treatment and six-month postbaseline smoking cessation outcomes . Baseline demographic , smoking-related , disease-related , and psychological variables were examined as predictors of biochemically-confirmed point-prevalence abstinence . Results . Multivariate analysis indicated that , for end-of-treatment abstinence , patients were significantly more likely to have quit smoking if they were older ( OR = 1.06 , 95 % CI : 1.03–1.10 , p < 0.05 ) and were diagnosed with a non-tobacco related cancer ( OR = 2.54 , 95 % CI : 1.24–5.20 , p < 0.05 ) . Likewise , for six-month abstinence , patients were significantly more likely to have quit smoking if they were older ( OR = 1.04 , 95 % CI : 1.01–1.08 , p < 0.05 ) and were significantly less likely to have quit smoking if they were female ( OR = 0.47 , 95 % CI : 0.22–0.97 , p < 0.05 ) . Patients with tobacco-related cancers and female patients reported significantly higher levels of depression symptoms ( p < 0.05 ) , which proved predictive of smoking relapse . Conclusions . Patient age , gender , and cancer-type may be important factors to consider when developing and implementing smoking cessation interventions for cancer patients Abstract BACKGROUND : This study evaluated the efficacy of bupropion for relapse prevention in smokers with and without a past history of major depressive disorder . Changes in depressive symptoms were also examined . DESIGN : Data were gathered prospect ively from a r and omized , double-blind relapse prevention trial of bupropion conducted at five study sites . A total of 784 smokers ( 54 % female , 97 % white ) were enrolled . Using the Structured Clinical Interview for Depression , 17 % of the subjects reported a past history of major depressive disorder at baseline . All subjects received open-label bupropion SR ( 300 mg/d ) for 7 weeks . Subjects abstinent from smoking at the end of 7 weeks ( N=429 ) were r and omized to bupropion SR ( 300 mg/d ) or placebo for the remainder of the year and followed for 1 year off medication . The primary outcome measures were median time to relapse to smoking and the 7-day point-prevalence smoking abstinence rate . Self-reported abstinence from smoking was verified by expired air carbon monoxide . The Beck Depression Inventory was used to assess depressive symptoms at baseline and at weeks 8 and 12 . RESULTS : Median time to relapse did not differ by past history of major depressive disorder . Bupropion was associated with higher point-prevalence smoking abstinence at the end of medication compared to placebo ( P=.007 ) , independent of a past history of major depressive disorder . Moreover , change in depressive symptoms during the double-blind phase did not differ for those with and without a past history of major depressive disorder . CONCLUSIONS : Extended use of bupropion for relapse prevention is effective for smokers with and without a history of major depression OBJECTIVE To evaluate the potential efficacy of bupropion sustained release when used in combination with minimal counseling for moist snuff cessation in males . METHODS A double-blind , placebo-controlled 3-month trial . The active treatment group ( n = 35 ) received bupropion SR at 150 mg/qd day for the first 3 days , then beginning day 4 through day 49 ( 7 weeks ) 150 mg/ b.i.d . The placebo group ( n= 35 ) received 1 tablet qd for 3 days and beginning day 4 through day 49 , 1 tablet/b.i.d . RESULTS Bupropion 300 mg/day ( 150 b.i.d . ) produced significantly higher quit rates for smokeless tobacco cessation at the end of treatment ( 7 weeks ) than placebo ( p = 0.04 ) with an OR of 2.73 . CONCLUSION Bupropion SR appears to be effective for smokeless tobacco cessation Stopping smoking is the only known method to slow down the inevitable progression of COPD . Early detection of the disease in smokers at risk of COPD gives a unique opportunity to prevent the disease progression . The aim of the study was to evaluate the effects of smoking intervention in a group of subjects with newly diagnosed airflow limitation ( AL ) . Of 558 current smokers participating in population spirometric screening for COPD combined with smoking cessation advice , 297 were diagnosed to have AL ( FEV1/FVC < 0.7 ) . After one year 193 presented for follow-up visit . Thirty subjects ( 10.1 % ) quit smoking . Remaining 163 smokers were invited to smokers ' clinic . Attendees ( n = 70 ) , 40 males , and 30 females , mean age 56 years , were r and omized at visit 1 to treatment with nicotine patch ( n = 38 ) or bupropion SR ( n = 32 ) . Follow-up was scheduled at 2 weeks , at the end of treatment , 6 months and 12 months . After 12 months a phone call assessed the smoking status . Non smoking was vali date d with carbon monoxide measurements in exhaled air . Patients who did not attend the follow-up visits were considered smokers . The number of participants at follow-up decreased significantly : from 70 subjects at visit one to 57 after 2 weeks , 34 at end of treatment and 14 subjects at months . Almost all ( n = 69 ) were reached at 12 month by the phone . The vali date d quit rate after 12 months was 18.5 % ( 13/70 ) , 8 in group treated with nicotine patch and 5 in the group treated with bupropion SR ( NS ) . When total group of smokers with newly diagnosed COPD was considered 10 % quit smoking as result of minimal intervention with another 4.5 % after pharmacological treatment The authors present results of a r and omized clinical trial of the efficacy of extended treatment with bupropion SR in producing longer term cigarette smoking cessation . Adult smokers ( N = 362 ) received open-label treatment ( 11 weeks ) that combined relapse prevention training , bupropion SR , and nicotine patch followed by extended treatment ( 14 weeks ) with bupropion SR or matching placebo . Abstinence percentages were relatively high ( week 11 : 52 % ; week 25 : bupropion , 42 % ; placebo , 38 % ; week 52 : bupropion , 33 % ; placebo , 34 % ) , but bupropion SR did not surpass placebo . Gender and baseline craving level were identified as significant , independent moderators of treatment response . Men were more likely to abstain than women ( week 11 : 59 % vs. 43 % , p = .001 ; week 25 : 48 % vs. 31 % , p = .001 ; week 52 : 39 % vs. 27 % , p = .01 ) . Because most smokers suffer relapse with any current cessation treatment , the comparatively high abstinence percentages achieved in this trial are of interest PURPOSE AND METHODS Cognitive behavior therapy ( CBT ) constitutes the basis of smoking cessation programs . Quitting rates are usually increased by the concomitant use of CBT and pharmacotherapy . There are studies showing the efficacy of bupropion and nortriptyline compared to placebo , but there is just one published comparison between these drugs , unfortunately with low power to detect significant differences . This study was design ed to compare the efficacy of bupropion , nortriptyline and placebo in a group of smokers who also received intensive counseling therapy . We conducted a double blind , double-dummy , placebo-controlled trial for smoking cessation that lasted 9 weeks . Patients were r and omized to receive nortriptyline 75 mg/day ( 52 subjects ) , bupropion 300 mg/day ( 53 subjects ) or placebo ( 51 subjects ) . All smokers also received the same intensive cognitive behavior therapy . The target day for quitting smoking was usually day 10 . Intensive counseling was provided at baseline , weekly during treatment , and at 10 , 13 , 16 , 20 and 26 weeks . Abstinence was defined as continuous when the subject was not smoking since the target-quitting day ( self-report ) and had an expired carbon monoxide concentration of 10 ppm or less . RESULTS The sustained abstinence rates at 6 months were 21.6 % in the placebo group , 30.8 % in the nortriptyline group ( p = 0.40 ) , and 41.5 % in the bupropion group ( p = 0.05 ) . The odds ratio was not statistically different for smokers using nortriptyline or bupropion ( OR 1.60 ; 95 % CI 0.66 - 3.86 ; p = 0.35 ) . The most common adverse events were dry mouth and drowsiness in the nortriptyline group and dry mouth and insomnia in the bupropion group . CONCLUSIONS Treatment with CBT + bupropion result ed in a better 6-month rate of smoking cessation compared to CBT+nortriptyline or CBT + placebo . Abstinence rate in the nortriptyline group was not statistically different from patients in the bupropion or placebo group Treatments that reduce the immediate effects of smoking withdrawal have potential for helping smokers quit . Serotonin-enhancing substances , such as tryptophan and high-carbohydrate diets , have been used in clinical disorders to relieve negative affect , a classic symptom of cigarette withdrawal . This research project investigated the use of tryptophan ( 50 mg/kg/day ) and high-carbohydrate diets , together with more traditional smoking cessation treatment techniques , to ameliorate the smoking withdrawal syndrome and to improve abstinence rates . Subjects were r and omly assigned to receive either tryptophan ( n=16 ) or placebo ( n=15 ) . St and ard smoking cessation treatment was identical for the experimental and control groups and consisted of four 2-hr weekly sessions of multicomponent group therapy . Smoking behavior , symptoms of nicotine withdrawal , and negative affect were assessed during a 2-week withdrawal period . Tryptophan-treated subjects who could not fully abstain were able to smoke fewer daily cigarettes . Reported anxiety and other withdrawal symptoms were lower in the tryptophan group compared with control subjects . These data suggest that serotonin-enhancing substances show promise for use as an adjunct to existing smoking cessation programs BACKGROUND Currently available smoking cessation therapies have limited success rates . Varenicline tartrate is a
Output:
| There is insufficient evidence that adding bupropion ( 12 trials , N = 3487 , RR 1.9 , 95 % CI 0.94 to 1.51 ) or nortriptyline ( 4 trials , N = 1644 , RR 1.21 , 95 % CI 0.94 to 1.55 ) to nicotine replacement therapy ( NRT ) provides an additional long-term benefit .
Bupropion has been associated with suicide risk , but whether this is causal is unclear .
Nortriptyline has the potential for serious side-effects , but none have been seen in the few small trials for smoking cessation .
The antidepressants bupropion and nortriptyline aid long-term smoking cessation .
Adverse events with either medication appear to rarely be serious or lead to stopping medication .
Evidence suggests that the mode of action of bupropion and nortriptyline is independent of their antidepressant effect and that they are of similar efficacy to nicotine replacement .
Evidence suggests that neither selective serotonin reuptake inhibitors ( e.g. fluoxetine ) nor monoamine oxidase inhibitors aid cessation |
MS212907 | ***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: OBJECTIVE To examine whether ( a ) Living in the Face of Trauma ( LIFT ) , a group intervention to address coping with HIV and childhood sexual abuse ( CSA ) , significantly reduced traumatic stress over a 1-year follow-up period more than an attention-matched support group comparison intervention ; and ( b ) reductions in avoidant coping over time mediated reductions in traumatic stress . METHOD In a r and omized controlled trial , 247 participants completed measures of traumatic stress and avoidant coping at pre- and post intervention , and at 4- , 8- , and 12-month follow-ups . Latent growth curve modeling examined changes over the 5 time points ; st and ardized path coefficients provide estimates of effects . RESULTS As compared with the support intervention , the coping intervention led to a reduction in traumatic stress over time ( b = -.20 , p < .02 ) . Participants in the coping intervention also reduced their use of avoidant coping strategies more than did participants in the support intervention ( b = -.22 , p < .05 ) . Mediation analyses showed reductions in avoidant coping related to reductions in traumatic stress ( b = 1.45 , p < .001 ) , and the direct effect of the intervention on traumatic stress was no longer significant ( b = .04 , ns ) , suggesting that changes in avoidant coping completely mediated intervention effects on traumatic stress . CONCLUSIONS The LIFT intervention significantly reduced traumatic stress over time , and changes in avoidant coping strategies mediated this effect , suggesting a focus on current stressors and coping skills improvement are important components in addressing traumatic stress for adults living with HIV and CSA Objective This r and omized clinical trial was design ed to compare the effects of a theory-based coping effectiveness training ( CET ) intervention with an active informational control ( HIV-Info ) condition and a waiting-list control ( WLC ) condition on psychological distress and positive mood in HIV-seropositive gay men . Material s and Methods The authors recruited 149 self-identified gay or bisexual men who were 21 to 60 years of age , reported depressed mood , and had CD4 levels of 200 to 700 cells/mm3 . CET and HIV-Info participants attended 10 90-minute group sessions during the 3-month intervention phase and six maintenance sessions over the remainder of the year . Participants were assessed at baseline and at 3 , 6 , and 12 months . Data were collected 1992 to 1994 , before the introduction of HAART . Analyses were based on the 128 participants who completed the 3-month assessment . Results After the 3-month intervention phase , when compared with HIV-Info , CET participants showed significantly greater decreases in perceived stress and burnout , and regression analyses indicated that significant increases in coping self-efficacy mediated the improvements in perceived stress and burnout . Compared with WLC , CET participants also showed significantly greater decreases in anxiety , and regression analyses indicated that significant increases in positive states of mind mediated the improvements in anxiety . Significant treatment group differences for positive morale were maintained at 6 and 12 months . In addition , optimism continued to increase in the CET and HIV-Info treatment groups during the maintenance phase . Conclusions CET can be an effective strategy for managing psychological distress and improving positive psychological states in patients confronting chronic illness Psychoneuroimmunology is a framework for mind-body practice and research that combines cutting-edge scientific exploration with holistic philosophy to appreciate and underst and stress responses . The rapidly growing research literature provides a foundation for building an integrative stress management model with the potential to positively influence the stress-disease relationship and , ultimately , health outcomes . This article introduces a novel tai chi intervention and provides quantitative and qualitative data from a r and omized clinical trial indicating its effects on psychosocial variables in individuals living with various stages of HIV disease To determine whether MBSR groups would help gay men living with HIV improve psychosocial functioning and increase mindfulness compared to treatment-as-usual ( TAU ) . Methods : 117 participants were r and omized 2:1 to MBSR or TAU . No new psychosocial or psychopharmacological interventions were initiated within 2 months of baseline . St and ardized question naires were administered pre- , postintervention and at 6 months . An intent-to-treat analysis found significant benefits of MBSR : at post-intervention and 6 months follow up , MBSR participants had significantly lower avoidance in IES and higher positive affect compared to controls . MBSR participants developed more mindfulness as measured by the Toronto Mindfulness Scale ( TMS ) including both TMS subscales , curiosity and decentering , at 8-week and 6 months . For the sample as a whole , increase in mindfulness was significantly correlated with reduction in avoidance , higher positive affect and improvement in depression at 6 months . MBSR has specific and clinical ly meaningful effects in this population Objectives : To examine the effect of a 15-session coping group intervention compared with a 15-session therapeutic support group intervention among HIV-positive men and women with a history of childhood sexual abuse ( CSA ) on sexual transmission risk behavior . Design : A r and omized controlled behavioral intervention trial with 12-month follow-up . Methods : A diverse sample of 247 HIV-positive men and women with histories of CSA was r and omized to 1 of 2 time-matched group intervention conditions . Sexual behavior was assessed at baseline ; immediately after the intervention ; and at 4- , 8- , and 12-month follow-up periods ( 5 assessment s ) . Changes in frequency of unprotected anal and vaginal intercourse by intervention condition were examined using generalized linear mixed models for all partners , and specifically for HIV-negative or serostatus unknown partners . Results : Participants in the HIV and trauma coping intervention condition decreased their frequency of unprotected sexual intercourse more than participants in the support intervention condition for all partners ( P < 0.001 ; d = 0.38 , 0.32 , and 0.38 at the 4- , 8- , and 12-month follow-up periods , respectively ) and for HIV-negative and serostatus unknown partners ( P < 0.001 ; d = 0.48 , 0.39 , and 0.04 at the 4- , 8- , and 12-month follow-up periods , respectively ) . Conclusion : A group intervention to address coping with HIV and CSA can be effective in reducing transmission risk behavior among HIV-positive men and women with histories of sexual trauma Background : AIDS-related bereavement is a severe life stressor that may be particularly distressing to persons themselves infected with HIV . Increasing evidence suggests that psychological health is associated with disease progression , HIV-related symptoms , and mortality . Purpose : This study assessed change in health-related quality of life among HIV+ persons following a group intervention for coping with AIDS-related loss . Methods : The sample included 235 HIV+ men and women of diverse ethnicities and sexual orientations who had experienced an AIDS-related loss within the previous 2 years . Participants were r and omly assigned to a 12-week cognitive-behavioral bereavement coping group intervention or offered individual psychotherapy upon request . Quality of life was assessed at baseline and 2 weeks after the intervention . Results : Participants in the group intervention demonstrated improvements in general health-related and HIV-specific quality of life , while those in the comparison remained the same or deteriorated . Effect sizes indicated that the majority of change occurred in women . Conclusion : This bereavement group aim ed at improving coping with grief also had a positive impact on health-related quality of life among HIV+ men and women , and suggests that cognitive-behavioral interventions may have a broad impact on both emotional and physical health OBJECTIVE We tested the effects of a 10-week group-based cognitive-behavioral stress management/expressive-supportive therapy intervention ( CBSM+ ) and a time-matched individual psychoeducational condition for 330 women with AIDS reporting moderate to poor baseline quality of life ( QOL ) . The goal of this study was to examine treatment effects on total QOL and 11 QOL domains from baseline to post-intervention follow-up . METHODS Participants were assessed at baseline , r and omized to a treatment condition ( individual psychoeducation condition n=180 , group-based CBSM+ condition n=150 ) , participated in the intervention for 10 weeks and assessed again within 4 weeks following the intervention . QOL was measured using the Medical Outcomes Study -HIV-30 . RESULTS QOL scores increased over the course of both interventions for the total QOL score and three QOL domains : cognitive functioning , health distress and overall health perceptions . While women in the CBSM+ group condition showed a significant improvement in mental health QOL from pre- to post-intervention , women in the individual condition did not change . No changes were observed for energy/fatigue , health transition , single-item overall QOL , pain , physical well-being , role functioning or social functioning in either condition . CONCLUSION Results suggest that group-based CBSM+ and individual psychoeducational interventions are effective at improving certain aspects of QOL and that group-based CBSM+ may be particularly effective at increasing QOL related to mental health in this population of women with AIDS We design ed a r and omized controlled trial of a home based intervention to improve antiretroviral adherence and to assess the impact of depressive symptoms among people living with HIV in Hunan , China . At baseline , 110 subjects reported taking 90 % or less of prescribed medication . At 6 months , when the intervention ended , 56 % of subjects in the control and 87 % of subjects in the experimental group were adherent . This difference was maintained at 12 months . In multivariate analyses , controlling for baseline visual analogue adherence scale , stigma , social support , and Center for Epidemiological Studies Depression scale , the experimental group had a significantly higher proportion of people who were adherent ( p=0.009 ) . The high prevalence of significant depressive symptoms ( 67 % ) at baseline is of concern . It is of particular importance that future studies look at the types of depression likely to be seen in these patients and differentiate early between those likely to benefit from HIV-related support and those who will require additional depression-targeted interventions Numerous herpesvirus infections are associated with clinical ly relevant outcomes as well as an accelerated HIV replication rate and subsequent disease progression . Stress management interventions mayimprovemarkersofcellularimmunecontroloverlatent herpesvirus infections and these changes appear to be mediated by perceptions of increased social support availability . We examined the effects ofagroup-based cognitive behavioral stress management ( CBSM ) intervention on distress , dysphoria , perceived socialsupport , and herpesvirus immunoglobulin G ( IgG ) antibody titers during the 6to 12 months following the intervention . Of those who were initially r and omized , 49 HIV-infected men were followed during the 6-to 12-month period after r and omization to either a 10-week CBSM intervention ( n=31 ) or amodified wait-list control condition ( n = 18 ) . Measures of distress , dysphoria , social support , and blood sample s for herpesvirus Ig Gtiters were taken at baseline , immediately following CBSM and at-6-to 12-month follow-up . Men in CBSM displayed maintenance of previously observed intervention effects on dysphoria , reliable alliance support , and herpesvirus IgG antibody titers ( i.e. , Epstein-Barr virus capsid antigen ; EBV-VCA ) . Intervention-related changes in EBV-VCA were unrelated to changes in lymphocyte subsets ( i.e. , CD4 + , CD8 + , and CD4+:CD8 + ) or changes in measures of dysphoria and social support during the investigation period . Data indicate that HIV-infected men participating in a CBS Mintervention maintain better psychosocial status and immunologic control of latent EBV infection up to 1 year after its conclusion OBJECTIVES Investigate the psychometric characteristics of the coping self-efficacy ( CSE ) scale , a 26-item measure of one 's confidence in performing coping behaviors when faced with life challenges . DESIGN Data came from two r and omized clinical trials ( N1=149 , N2=199 ) evaluating a theory-based Coping Effectiveness Training ( CET ) intervention in reducing psychological distress and increasing positive mood in persons coping with chronic illness . METHODS The 348 participants were HIV-seropositive men with depressed mood who have sex with men . Participants were r and omly assigned to intervention and comparison conditions and assessed pre- and post-intervention . Outcome variables included the CSE scale , ways of coping , and measures of social support and psychological distress and well-being . RESULTS Exploratory ( EFA ) and confirmatory factor analyses ( CFA ) revealed a 13-item reduced form of the CSE scale with three factors : Use problem-focused coping ( 6 items , alpha=.91 ) , stop unpleasant emotions and thoughts ( 4 items , alpha=.91 ) , and get support from friends and family ( 3 items , alpha=.80 ) . Internal consistency and test-retest reliability are strong for all three factors . Concurrent validity analyses showed these factors assess self-efficacy for different types of coping . Predictive validity analyses showed that residualized change scores in using problem- and emotion-focused coping skills were predictive of reduced psychological distress and increased psychological well-being over time . CONCLUSIONS The CSE scale provides a measure of a person 's perceived ability to cope effectively with life challenges , as well as a way to assess changes in CSE over time in inter
Output:
| Authors ' conclusions Group‐based psychosocial interventions may have a small effect on measures of depression , but the clinical importance of this is unclear .
More high quality evidence is needed to assess whether group psychosocial intervention improve psychological well‐being in HIV positive adults |
MS212908 | ***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 Many intensive care patients experience sleep disruption potentially related tonoise , light and treatment interventions . The purpose of this study was tocharacterise , in terms of quantity and quality , the sleep of intensive care patients , taking into account the impact of environmental factors . Methods This observational study was conducted in the adult ICU of a tertiary referralhospital in Australia , enrolling 57 patients . Polysomnography ( PSG ) was performedover a 24-hour period to assess the quantity ( total sleep time : hh : mm ) and quality ( percentage per stage , duration of sleep episode ) of patients ' sleep while in ICU.Rechtschaffen and Kales criteria were used to categorise sleep . Interrater checkswere performed . Sound pressure and illuminance levels and care events weresimultaneously recorded . Patients reported on their sleep quality in ICU using theRichards Campbell Sleep Question naire and the Sleep in Intensive Care Question naire . Data were summarised using frequencies and proportions or measures of central tendency and dispersion as appropriate and Cohen 's Kappa statistic wasused for interrater reliability of the sleep data analysis . Results Patients ' median total sleep time was 05:00 ( IQR : 02:52 to 07:14 ) . The majority ofsleep was stage 1 and 2 ( medians : 19 and 73 % ) with scant slow wave and REM sleep . The median duration of sleep without waking was 00:03 . Sound levels were high(mean Leq 53.95 dB(A ) during the day and 50.20 dB(A ) at night ) and illuminancelevels were appropriate at night ( median < 2 lux ) but low during the day(median : 74.20 lux ) . There was a median 1.7 care events/h . Patients ' meanself-reported sleep quality was poor . Interrater reliability of sleep staging washighest for slow wave sleep and lowest for stage 1 sleep . Conclusions The quantity and quality of sleep in intensive care patients are poor and may berelated to noise , critical illness itself and treatment events that disturb sleep . The study highlights the challenge of quantifying sleep in the critical care setting and the need for alternative methods of measuring sleep . The results suggest that a sound reduction program is required and other interventions toimprove clinical practice s to promote sleep in intensive care patients .Trial registration Australian New Zeal and clinical trial registry(http://www.anzctr.org.au/ ) : ACTRN12610000688088 Objective To assess survival , morbidity ( physical and psychological ) , quality of life ( QOL ) , and employment status of intensive care survivors up to 12 months after discharge from the intensive care unit ( ICU ) . Design Prospect i ve study . Setting University hospital adult ICU . Patients Between August 1 , 1995 , and July 31 , 1996 , 370 patients were admitted . Of these patients , 29 % died in the ICU . Three months after discharge from the ICU , 227 patients were alive , and 143 agreed to participate . Cumulative mortality was calculated using the original complete cohort . Measurements and Main Results Demographic data , severity of acute illness ( Acute Physiology and Chronic Health Evaluation [ APACHE ] II ) , admitting specialty , primary diagnosis , and length of stay were recorded . Physical and ICU-related psychological morbidity ( Hospital Anxiety and Depression scale score ) were recorded . Health-related QOL was assessed using the Short-Form 36 . All the question naires were completed in the clinic at 3 months . Assessment of physical morbidity and employment status at 6 and 12 months were conducted by telephone . The cumulative mortality was 39 % at 3 months , 41 % at 6 months , and 43 % at 12 months . Deaths after 3 months occurred in the group who refused follow-up . The median age for the follow-up group was 51 yrs ; the gender split was 68 women and 75 men ; the mean admission APACHE II score was 18.79 ( sd 6.15 ) ; and the median length of ICU stay was 3.8 days . At 3 months , ∼80 % of all patients interviewed were satisfied with their QOL . Older men ( > 65 yrs ) and younger women ( < 65 yrs ) demonstrated significantly better health with respect to some subdomains of the Short-Form 36 compared with their counterparts . The prevalence of psychological distress ( Hospital Anxiety and Depression scale score , ≥8 ) was low : 11.9 % had heightened anxiety , and 9.8 % were depressed . There were high levels of fatigue , poor concentration , and sleep disturbance ; the latter was more marked in women ( p = .022 ) . Improvement in all three symptoms occurred during the next 9 months . Significantly more women reported loss of hair ( p < .0001 ) . Men were slower to return to employment ; 75 % of women had returned by 6 months compared with only 65 % of men at 1 yr . Conclusion Assessment of outcome after ICU stay must include QOL measurements . Three months after discharge , there is a low incidence of ICU-related psychological or psychiatric illness and the majority of patients are satisfied . Differences in the incidence and nature of morbidity exist between the genders Background Delirium is an acute state of brain dysfunction characterised by fluctuating inattention and cognitive disturbances , usually due to illness . It occurs commonly in the intensive care unit ( ICU ) , and it is associated with greater morbidity and mortality . It is likely that disturbances of sleep and of the day-night cycle play a significant role . Melatonin is a naturally occurring , safe and cheap hormone that can be administered to improve sleep . The main aim of this trial will be to determine whether prophylactic melatonin administered to critically ill adults , when compared with placebo , decreases the rate of delirium . Methods This trial will be a multi-centre , r and omised , placebo-controlled study conducted in closed ICUs in Australia . Our aim is to enrol 850 adult patients with an expected ICU length of stay ( LOS ) of 72 h or more . Eligible patients for whom there is consent will be r and omised to receive melatonin 4 mg enterally or placebo in a 1:1 ratio according to a computer-generated r and omisation list , stratified by site . The study drug will be indistinguishable from placebo . Patients , doctors , nurses , investigators and statisticians will be blinded . Melatonin or placebo will be administered once per day at 21:00 until ICU discharge or 14 days after enrolment , whichever occurs first . Trained staff will assess patients twice daily to determine the presence or absence of delirium using the Confusion Assessment Method for the ICU score . Data will also be collected on demographics , the overall prevalence of delirium , duration and severity of delirium , sleep quality , participation in physiotherapy sessions , ICU and hospital LOS , morbidity and mortality , and healthcare costs . A subgroup of 100 patients will undergo polysomnographic testing to further evaluate the quality of sleep . Discussion Delirium is a significant issue in ICU because of its frequency and associated poorer outcomes . This trial will be the largest evaluation of melatonin as a prophylactic agent to prevent delirium in the critically ill population . This study will also provide one of the largest series of polysomnographic testing done in ICU.Trial registration Australian New Zeal and Clinical Trial Registry ( ANZCTR ) number : ACTRN12616000436471 . Registered on 20 December 2015 The Bispectral Index ( BIS ) is a system used to measure sedation levels . Some investigators recently analyzed changes in the BIS during natural sleep in adults and found that the BIS diminished considerably as sleep became deeper . No such studies have been undertaken to investigate changes in the BIS in sleeping children . The aim of this work was to assess the trend of the BIS in the various stages of sleep in a group of children , performing a descriptive analysis on a limited number of cases . We evaluated 15 children with negative clinical findings and a normal electroencephalogram ( EEG ) as part of their follow-up for prior episodes of epilepsy , recording the BIS and EEG in a waking state , in the various stages of sleep and on reawaking . For each stage , the mean value , the st and ard deviation , and the range of BIS values were calculated . The results showed that the BIS decreased progressively as sleep became deeper . The correlation between the stage of sleep and the BIS was significant . On reawaking , a slow increase was apparent in the BIS In this study , the aim was to test the biochemical effects of melatonin supplementation in Intensive Care Unit ( ICU ) patients , since their blood levels are decreased . Sixty-four patients were enrolled in the study . From the evening of the 3rd ICU day , patients were r and omized to receive oral melatonin ( 3 mg , group M ) or placebo ( group P ) twice daily , at 20:00 and 24:00 , until discharged . Blood was taken ( at 00:00 and 14:00 ) , on the 3rd ICU day to assess basal nocturnal melatonin values , and then during the treatment period on the 4th and 8th ICU days . Melatonin , total antioxidant capacity , and oxidative stress were evaluated in serum . Melatonin circadian rhythm before treatment was similar in the two groups , with a partial preservation of the cycle . Four hours from the 1st administration ( 4th ICU day , 00:00 ) , melatonin levels increased to 2514 ( 982.3 ; 7148 ) pg·mL−1 in group M vs. 20.3 ( 14.7 ; 62.3 ) pg·mL−1 in group P ( p < 0.001 ) . After five treatment days ( 8th ICU day ) , melatonin absorption showed a repetitive trend in group M , while in group P nocturnal secretion ( 00:00 ) was impaired : 20 ( 11.5 ; 34.5 ) pg·mL−1 vs. 33.8 ( 25.0 ; 62.2 ) on the 3rd day ( p = 0.029 ) . Immediately from the beginning of treatment , the total antioxidant capacity was significantly higher in melatonin treated subjects at 00:00 ; a significant correlation was found between total antioxidant capacity and blood melatonin values ( ρ = 0.328 ; p < 0.001 ) . The proposed enteral administration protocol was adequate , even in the early phase , to enhance melatonin blood levels and to protect the patients from oxidative stress . The antioxidant effect of melatonin could play a meaningful role in the care and well-being of these patients Background Sleep deprivation is common in critically ill patients in intensive care units ( ICU ) . It can result in delirium , difficulty weaning , repeated nosocomial infections , prolonged ICU length of stay and increased ICU mortality . Melatonin , a physiological sleep regulator , is well known to benefit sleep quality in certain people , but evidence for the effectiveness in ICU sleep disturbance is limited . Methods / Design This study has a prospect i ve , r and omized , double-blind , controlled , parallel-group design . Eligible patients are r and omly assigned to one of the two treatment study groups , labelled the ‘ melatonin group ’ or the ‘ placebo group ’ . A dose of 3 mg of oral melatonin or placebo is administered at 9:00 pm on four consecutive days . Earplugs and eye masks are made available to every participant . We plan to enrol 198 patients . The primary outcome is the objective sleep quality measured by the 24-hour polysomnography . The secondary outcomes are the subjective sleep quality assessed by the Richards Campbell Sleep Question naire , the anxiety level evaluated by the Visual Analogue Scale-Anxiety , the number of delirium-free days in 8 and 28 days , the number of ventilation-free days in 28 days , the number of antibiotic-free days , ICU length of stay , the overall ICU mortality in 28 days and the incidence and severity of the side effects of melatonin in ICU patients . Additionally , the body stress levels , oxidative stress levels and inflammation levels are obtained via measuring the plasma melatonin , cortisone , norepinephrine , malonaldehyde(MDA ) , superoxide dismutase(SOD ) , interleukin-6 ( IL-6 ) and interleukin-8 (IL-8)concentrations . Discussion The proposed study will be the first r and omized controlled study to use the polysomnography , which is the gold st and ard of assessing sleep quality , to evaluate the effect of melatonin on the sleep quality and circadian rhythms of ICU patients . The results may recommend a new treatment for ICU patients with sleep deprivation that is safe , effective and easily implementable in daily practice .Trial registration This study was registered with Clinical Trials ( NCT ; registration number : ChiCTR-TRC-14004319 ) on 4 March 2013 BACKGROUND AND AIM Patients in the intensive care unit often suffer from lack of sleep at night . We hypothesised that nocturnal melatonin may increase observed nocturnal sleep in tracheostomised patients . DESIGN Double-blind , r and omised , placebo-controlled pilot study . SETTING ICU of a tertiary hospital . PARTICIPANTS Thirty-two ICU patients with tracheostomy who were not receiving continuous sedation . METHODS We administered either oral melatonin ( 3 mg ) or placebo at 20:00 . We collected pre- and post-dosage blood sample s on Days 1 and 3 to confirm drug delivery . Primary outcome measure was number of hours of observed sleep at night , assessed by the
Output:
| We found insufficient evidence to determine whether administration of melatonin would improve the quality and quantity of sleep in ICU patients . |
MS212909 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: PURPOSE We assessed the correlation of skeletal fracture with survival in men with prostate cancer on chronic and rogen suppressive therapy . MATERIAL S AND METHODS A total of 195 consecutive patients on chronic and rogen suppression for prostate cancer were evaluated for the history and type of skeletal fracture . Correlation with overall survival was performed via multivariate analysis . RESULTS Of these 195 men 24 reported skeletal fracture since the diagnosis of prostate cancer . Median overall survival was 121 and 160 months in men without and with a history of skeletal fracture since the diagnosis of prostate cancer , respectively ( p = 0.04 ) . A history of skeletal fracture was retained as a negative predictor of survival on forward stepwise regression analysis ( RR = 7.4 , p = 0.007 ) . CONCLUSIONS Our results suggest that skeletal fracture in patients with prostate cancer is an independent and adverse predictor of survival . Consideration for screening men at greatest risk via bone mineral density measurements and initiating empirical skeletal therapies ( bisphosphonates , estrogens and so forth ) may be warranted . This recommendation awaits validation through prospect i ve r and omized trials The results of a retrospective exploratory analysis of a phase III trial of zoledronic acid in patients with bone metastases secondary to lung cancer or other solid tumors are reported herein to assess the risk of skeletal-related events ( SREs ) and the efficacy of 4 mg zoledronic acid compared with placebo . The study is based on patient SRE history before study entry . Patients were stratified based on SRE history ( eg , pathologic fracture , spinal cord compression , radiation therapy or surgery to bone , or hypercalcemia ) before study entry , and SRE incidence over 21 months was analyzed . Of 507 patients r and omized to 4 mg zoledronic acid or placebo , 131 completed the 9-month core phase and 69 entered the 12-month extension phase . Before study entry , 347 of 503 patients who were evaluable for efficacy ( 69 % ) experienced > /= 1 SRE ; these patients had a higher risk of developing an SRE on study than patients with no prior SRE ( odds ratio , 1.41 ) . Among patients with an SRE before study entry , zoledronic acid reduced the risk of SREs by 31 % ( P = 0.009 ) , reduced the mean skeletal morbidity rate ( 1.96 vs. 2.81 SREs per year for placebo ; P = 0.030 ) , and prolonged the median time to first SRE by nearly 4 months ( 215 days vs. 106 days for placebo ; P = 0.011 ) . Among patients with no SRE before study entry ( n = 156 ) , zoledronic acid reduced the risk of SREs by 23 % ( P = 0.308 ) , reduced the mean skeletal morbidity rate ( 1.34 vs. 2.53 SREs per year for placebo ; P = 0.332 ) , and prolonged the median time to first SRE by 2.5 months ( P = 0.534 ) . This exploratory analysis demonstrates that patients with a history of SREs are at high risk for subsequent SREs , but zoledronic acid reduces skeletal morbidity regardless of SRE history This study was design ed to evaluate the efficacy and safety of combined zoledronic acid and docetaxel/carboplatin in patients with non-small cell lung cancer ( NSCLC ) as pre clinical studies showed synergistic antitumoral activity with bisphosphonates and docetaxel . Patients with inoperable stage IIIB or stage IV NSCLC were r and omized 2:1 to receive docetaxel 75mg/m(2 ) and carboplatin area under the concentration time curve 6 with ( Arm A ) or without ( Arm B ) zoledronic acid 4 mg every 3 weeks for 6 cycles . Patients responding in Arm A were rer and omized to receive monthly zoledronic acid ( maximum : 12 months [ Arm A1 ] or no zoledronic acid [ Arm A2 ] ) . Patients responding in Arm B entered Arm B1 for follow-up evaluation only . The primary endpoint was the proportion of patients without disease progression ; secondary endpoints were time to disease progression ( TTP ) , TTP in bone , best overall response rate , 1-year overall survival ( OS ) time , and safety ; study not powered to detect endpoint differences . Of 150 patients , 98 were r and omized to Arm A and 52 to Arm B. In the treatment phase , results were similar between groups in the proportion of patients without disease progression ( 40.9 % vs 38.8 % ; P=.8096 ) and median TTP ( 132d vs 132d ; P=.9622 ) . One-year OS times and best overall response rates were 266d vs 206d ( P=.4855 ) and 64.1 % vs 72 % ( P=.3423 ) , respectively ; the study was not powered to detect differences . In the follow-up phase , TTP and OS time were similar . Adding zoledronic acid to docetaxel/carboplatin in advanced stage NSCLC patients was well tolerated , but provided little to no effect on disease progression endpoints
Output:
| Conclusions Treatment with bisphosphonates reduced SREs , improved pain control , and showed a trend to increased survival . |
MS212910 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE This study assessed the percentage of the amount of dentifrice loaded onto the toothbrush that is ingested by children , taking into account age , the amount of dentifrice used during toothbrushing , and the dentifrice flavor . METHODS The sample consisted of 155 children of both genders attending public kindergartens and schools in Bauru , Brazil , divided into 5 groups ( n = 30 - 32 ) of children aged 2 , 3 , 4 , 5 and 6 years old . The dentifrices used were Sorriso ™ ( 1219 ppm F , peppermint-flavored ) and T and y ™ ( 959 ppm F , tutti-frutti-flavored ) . The assessment of fluoride intake from dentifrices was carried out six times for each child , using 0.3 , 0.6 , and 1.2 g of each dentifrice , following a r and om , crossover distribution . Brushing was performed by the children or their parents/caregivers according to the home habits and under the observation of the examiner . Fluoride present in the expectorant and on toothbrush was analyzed with an ion-specific electrode after HMDS-facilitated diffusion . Fluoride ingestion was indirectly derived . Results were analyzed by 3-way repeated- measures anova and Tukey 's tests ( P < 0.05 ) using the percent dentifrice ingested as response variable . RESULTS Age and percent dentifrice ingested for both dentifrices , and the three amounts used were inversely related ( P < 0.0001 ) . Percent dentifrice ingested was significantly higher after the use of T and y ™ under all conditions of the study when compared with Sorriso ™ ( P < 0.0001 ) . Significant differences were observed when brushing with 0.3 g when compared with 1.2 g , for both dentifrices tested ( P < 0.05 ) . CONCLUSIONS The results indicate that all variables tested must be considered in preventive measures aim ing to reduce the amount of fluoride ingested by young children The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement was developed to improve the reporting of r and omised controlled trials . It was initially published in 1996 and focused on the reporting of parallel group r and omised controlled trials . The statement was revised in 2001 , with a further up date in 2010 . A separate CONSORT statement for the reporting of abstract s was published in 2008 . In earlier papers we considered the implication s of the 2001 version of the CONSORT statement for the reporting of cluster r and omised trial . In this paper we provide up date d and extended guidance , based on the 2010 version of the CONSORT statement and the 2008 CONSORT statement for the reporting of abstract s. To investigate the effectiveness of 3 caries-preventive measures on high– and low – caries risk occlusal surfaces of first permanent molars over 3 y. This cluster-r and omized controlled clinical trial covered 242 schoolchildren , 6 to 7 y old , from low socioeconomic areas . At baseline , caries risk was assessed at the tooth surface level , through a combination of ICDAS II ( International Caries Detection and Assessment System ) and fissure depth codes . High – caries risk occlusal surfaces were treated according to daily supervised toothbrushing ( STB ) at school and 2 sealants : composite resin ( CR ) and atraumatic restorative treatment – high-viscosity glass-ionomer cement ( ART-GIC ) . Low – caries risk occlusal surfaces received STB or no intervention . Evaluations were performed after 0.5 , 1 , 2 , and 3 y. A cavitated dentine carious lesion was considered a failure . Data were analyzed according to the proportional hazard rate regression model with frailty correction , Wald test , analysis of variance , and t test , according to the jackknife procedure for calculating st and ard errors . The cumulative survival rates of cavitated dentine carious lesion – free , high – caries risk occlusal surfaces were 95.6 % , 91.4 % , and 90.2 % for STB , CR , and ART-GIC , respectively , over 3 y , which were not statistically significantly different . For low – caries risk occlusal surfaces , no statistically significant difference was observed between the cumulative survival rate of the STB group ( 94.8 % ) and the no-intervention group ( 92.1 % ) over 3 y. There was neither a difference among STB , CR , and ART-GIC on school premises in preventing cavitated dentine carious lesions in high – caries risk occlusal surfaces of first permanent molars nor a difference between STB and no intervention for low – caries risk occlusal surfaces of first permanent molars over 3 Children in the London Boroughs of Kensington , Chelsea and Westminster have one of the highest levels of caries in Engl and and Wales . In 1997/98 , the mean dmft for 5-year-old children was 2.83 with only 45.9 % of the children being caries free . The aim of this study was to determine whether teacher-supervised toothbrushing , once a day , at school , during term time , with commercial toothpaste containing 1,450 ppm fluoride , could reduce dental caries in primary school children when compared with children from the same community who did not receive this intervention . A total of 517 children ( mean age 5.63 years ) were recruited for the study . Class teachers were trained individually by the same dental hygienist in an appropriate toothbrushing technique for young children . Children in the intervention group brushed once a day at school . All examinations were by visual assessment only . All teeth present were assessed using the BASCD criteria . For children in the intervention group , the overall caries increment ( 2.60 ) was significantly less ( 10.9 % ; p < 0.001 ) than for children in the non-intervention group ( 2.92 ) . Among different tooth surfaces , the difference in caries increment between the intervention group ( 0.78 ) and the non-intervention group ( 1.03 ) was greatest for the proximal surfaces ( 21.4 % ; p < 0.01 ) . In conclusion , this study suggests that a programme of daily teacher-supervised toothbrushing with fluoride toothpaste can be effectively targeted into socially deprived communities and a significant reduction in dental caries can thereby be achieved especially among caries-susceptible children Objectives The aim of the study was to evaluate the effect of an intensified preventive programme in kindergartens . Material s and methods Two thous and two hundred twenty-eight 2- to 4-year-old children attending kindergartens in two counties in northern Hesse were r and omly allocated to two groups . Children in the test group participated in daily tooth brushing with 500 ppm fluoride toothpaste , which was supervised by specially trained dental nurses . Children in the control group received tooth brushing instructions three to four times a year . Caries experience was recorded using WHO criteria . The basic survey was performed from October 2006 to April 2007 , with the final examinations between March and July 2009 . The statistical evaluation was performed by means of the software package SPSS 17.0 . To compare the mean Δdmf values of the test and control groups , Mann-Whitney U tests were performed . Results Two thous and one hundred twelve children ( test group , 1096 ; control group , 1048 ) participated in the final examinations . The caries increment of the test group ( Δdmf-s = 1.55 ) was 24 % lower than the increment of the control group ( Δdmf-s = 2.02 , p = 0.043 ) . Based on Δdmf-t values , the corresponding figures were 0.79 for the test group and 1 for the control group ( p = 0.44 ) . High increment values ( Δdmf-s > 7 ) were observed in the control group twice as often as in the test group . Conclusion The results show that an intensified preventive programme in kindergartens , based on supervised daily tooth brushing , has a positive effect on the dental health of preschool children . Clinical relevance It is sufficient to offer such programmes in socially deprived areas Scottish children have one of the highest levels of caries experience in Europe . Only 33 % of 5-year-old children in Dundee who developed caries in their first permanent molars by 7 brushed their teeth twice a day . High-caries-risk children should benefit if they brush more often with fluori date d toothpaste . The aim of this clinical trial was to determine the reduction in 2-year caries increment that can be achieved by daily supervised toothbrushing on school-days with a toothpaste containing 1,000 ppm fluoride ( as sodium monofluorophosphate ) and 0.13 % calcium glycerophosphate , combined with recommended daily home use , compared to a control group involving no intervention other than 6-monthly clinical examinations . Five hundred and thirty-four children , mean age 5.3 , in schools in deprived areas of Tayside were recruited . Each school had two parallel classes , one r and omly selected to be the brushing class and the other , the control . Local mothers were trained as toothbrushing supervisors . Children brushed on school-days and received home supplies . A single examiner undertook 6-monthly examinations recording plaque , caries ( D1 level ) , and used FOTI to supplement the visual caries examination . For children in the brushing classes , the 2-year mean caries increment on first permanent molars was 0.81 at D1 and 0.21 at D3 compared to 1.19 and 0.48 for children in the control classes ( significant reductions of 32 % at D1 and 56 % at D3 ) . In conclusion , high-caries-risk children have been shown to have significantly less caries after participating in a supervised toothbrushing programme with a fluori date d toothpaste OBJECTIVES To evaluate the effect of a 2-year oral health education and caries prevention program implemented in kindergartens in China . METHODS Seven hundred and thirty-one 3-year-old children were recruited from 10 kindergartens in Miyun County , Beijing , China . The kindergartens were r and omly divided into two groups . Oral health education was provided to teachers in the test kindergartens every 3 months . Oral health education sessions were conducted for the test children monthly and for their parents semiannually . Children in the test kindergarten brushed their teeth twice daily with fluori date d toothpaste ( 1100 ppm F- ) in their kindergarten under the supervision of teachers during weekdays . No oral health education session and no supervised tooth brushing activities were carried out in the control kindergartens . A clinical examination of the study children and a question naire survey of their parents were conducted at baseline and after a 2-year program . RESULTS Five hundred and fourteen children remained in the study after 2 years . The mean caries increments of the test group ( n = 258 ) and the control group ( n = 256 ) were 2.47 and 3.56 dmfs , respectively . The reduction in dmfs increment was 30.6 % ( P = 0.009 ) . At the evaluation , a significantly higher percentage of children in the test group than in the control group reported brushing their teeth twice a day ( 87.6 % vs. 69.0 % ; P < 0.001 ) . Parents of children in the test group had better oral health knowledge and attitude than the parents of children in the control group . CONCLUSION This oral health education program was effective in establishing good oral health habits among preschool children and in increasing oral health knowledge of their parents , in conjunction with supervised daily tooth brushing with fluori date d toothpaste , which could reduce the development of new dental caries in preschool children in China
Output:
| There is no conclusive evidence regarding the effectiveness of supervised toothbrushing on caries incidence |
MS212911 | ***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 objective of the present study was to evaluate the effect of the two methods of delivery , “ h and s-on ” vs. “ h and s poised ” , on perineal trauma and delivery outcome in primiparous women referred to Shariati Hospital of Isfahan during 2007 - 2008 . METHODS : In a clinical trial study , 100 low risk primiparous pregnant women were r and omly assigned to two h and s-on and h and -poised ( h and s-off ) groups . In the h and s-on group , this method was used to control fetal head in the second stage of labor . It means that the fingers of one h and supported fetal occiput and the other h and applied slight pressure on the head to control the delivery of the head during the crowning process . In the h and s-poised group , midwife observed the parturient woman and do not touch perineum during the second labor stage while fetal head was delivering . Then , the two groups were compared in terms of perineal trauma , as well as neonatal and delivery outcome . RESULTS : Demographic characteristics of all studied women were similar in two groups . The rate of episiotomy was higher in h and s-on group ( 84 % vs. 40 % , p = 0.001 ) . The rate of postpartum hemorrhage ( 4th stage ) was higher in h and s-on group ( 12 % vs. 4 % , p = 0.04 ) . The rate of mild and moderate postpartum pain in h and s-on group was higher than h and s-off group ( 70 % vs. 58 % and 29 % vs. 10 % , p < 0.001 ) but sever pain was not different in two groups . CONCLUSIONS : It seems that h and s-poised method is associated with less perineal trauma , particularly regarding the lower need for episiotomy and postpartum hemorrhage OBJECTIVE To investigate the influence of the traditional h and s-on versus the innovative h and s-poised method on the risk of perineal trauma during vaginal delivery and on neonatal outcomes . STUDY DESIGN In a prospect i ve , r and omized , multicenter study , 1,161 of 1,505 women giving birth at the Departments of Obstetrics and Gynecology of the University Hospital of Vienna and Semmelweis Women 's Hospital , Vienna , between February and September 1999 , were r and omized into the trial . In the h and s-on method , the left h and of the midwife puts pressure on the infant 's head , and the right h and is placed against the perineum . In the h and s-poised method , the midwife guides the parturient through the birth without touching the perineum , prepared to apply light pressure on the infant 's head . RESULTS One hundred eighty-seven of 574 women ( 32.5 % ) in the h and s-on group and 180 of 502 women ( 35.8 % ) in the h and s-poised group experienced perineal tears ( P = .5 ) . Sixteen women ( 2.7 % ) treated with the h and s-on method developed third-degree perineal tears as compared with five women ( 0.9 % ) treated with the h and s-poised method ( P < .05 ) . In the h and s-on group , 103 women ( 17.9 % ) underwent episiotomy as compared with 51 cases ( 10.1 % ) in the h and s-poised group ( P < .01 ) . No significant differences in neonatal outcomes were observed between the two groups . CONCLUSION Our data suggest that a policy of h and s-poised care is more suitable for preserving the perineum during birth and is a safe and effective birthing alternative for women Summary Background The purpose of this study was to compare the obstetric outcome of low-risk maternity patients attended by certified midwives with that of low-risk maternity patients attended by obstetricians . Patients and methods Obstetric outcome of 1352 midwife patients was compared with that of 1352 age- and parity-matched physician patients with normal spontaneous vaginal delivery at the Department of Obstetrics and Gynecology of the University Hospital Vienna during the period from January 1997 to July 2002 . Our analysis was restricted to a sample of low-risk pregnant women . Women with medical or obstetric risk factors were excluded . Results A significant decrease in the use of oxytocin ( p=0.0001 ) was observed in women who selected a midwife as their primary birth attendant compared with women in the physician group . In both groups most women gave birth in a supine position ; however , significantly more alternative birth positions were used by midwife patients ( p=0.0001 ) . Concerning perineal trauma , a significantly lower rate of episiotomies ( p=0.0001 ) and perineal tears of all degrees ( p=0.006 ) were found in midwife patients . When analyzing severe postpartum hemorrhage and postpartum infections , there were no significant differences between the two groups ( p>0.05 ) . Concerning neonatal outcome , there were no significant differences in APGAR score < 7 at 5 minutes (p>0.05).Our data clearly show the ability of certified midwives to successfully provide prenatal care and delivery to lowrisk maternity patients , with neonatal outcomes comparable to those of physician patients . The use of certified midwives supervised by obstetricians may provide the optimum model for perinatal care , particularly for those women who are low-risk maternity patients , leaving physicians free to attend to the high-risk elements of care Background Whether certain birth positions are associated with perineal injuries and severe perineal trauma ( SPT ) is still unclear . The objective of this study was to describe the prevalence of perineal injuries of different severity in a low-risk population of women who planned to give birth at home and to compare the prevalence of perineal injuries , SPT and episiotomy in different birth positions in four Nordic countries . Methods A population -based prospect i ve cohort study of planned home births in four Nordic countries . To assess medical outcomes a question naire completed after birth by the attending midwife was used . Descriptive statistics , bivariate analysis and logistic regression were used to analyze the data . Results Two thous and nine hundred ninety-two women with planned home births , who birthed spontaneously at home or after transfer to hospital , between 2008 and 2013 were included . The prevalence of SPT was 0.7 % and the prevalence of episiotomy was 1.0 % . There were differences between the countries regarding all maternal characteristics . No association between flexible sacrum positions and sutured perineal injuries was found ( OR 1.02 ; 95 % CI 0.86–1.21 ) or SPT ( OR 0.68 ; CI 95 % 0.26–1.79 ) . Flexible sacrum positions were associated with fewer episiotomies ( OR 0.20 ; CI 95 % 0.10–0.54 ) . Conclusion A low prevalence of SPT and episiotomy was found among women opting for a home birth in four Nordic countries . Women used a variety of birth positions and a majority gave birth in flexible sacrum positions . No associations were found between flexible sacrum positions and SPT . Flexible sacrum positions were associated with fewer episiotomies Background : Many women suffer from perineal trauma during the normal vaginal delivery . Perineal trauma is mainly associated with pain and complications after the childbirth . Perineal management techniques can play a significant role in perineal trauma reduction . This study aim ed to compare the effects of perineal management techniques ( h and s-off technique , Ritgen maneuver and perineal massage using a lubricant during delivery ) on the labor complications . Material s and Methods : This quasi-experimental clinical trial was conducted on 99 primiparous women who referred to Daran Hospital , Isfahan , Iran for normal vaginal delivery in 2009 . The subjects were selected using a convenient method and r and omly assigned to three groups of Ritgen maneuver , h and s-off technique and perineal massage with lubricant . A question naire was used to determine the demographic characteristics of the participants and complications after birth . The short form of McGill Pain Question naire and the visual analogue scale for pain were also employed . The incidence and degree of perineal tears were evaluated immediately after delivery . Moreover , the incidence and severity of perineal pain were assessed 24 hours and also 6 weeks after delivery . Findings : In the Ritgen maneuver group , the frequency of tears , the relative frequency of tear degrees , the severity of perineal pain 24 hours after delivery and the frequency of pain and perineal pain severity 6 weeks after delivery were significantly different from the other two methods . Conclusions : H and s-off technique during parturition of the neonate 's head was associated with fewer complications after delivery . It was even better than perineal massage during the parturition OBJECTIVE The objective of the study was to determine whether bed delivery without stirrups reduces the incidence of perineal lacerations compared with delivery in stirrups . STUDY DESIGN In this r and omized trial , we compared bed delivery without stirrups with delivery in stirrups in nulliparous women . The primary outcome was any perineal laceration ( first through fourth degree ) . RESULTS One hundred eight women were r and omized to delivery without stirrups and 106 to stirrups . A total of 82 women r and omized to no stirrups ( 76 % ) sustained perineal lacerations compared with 83 in women allocated to stirrups ( 78 % ) ( P = .8 ) . There was no significant difference in the severity of lacerations or in obstetric outcomes such as prolonged second stage of labor , forceps delivery , or cesarean birth . Similarly , infant outcomes were unaffected . CONCLUSION Our results do not incriminate stirrups as a cause of perineal lacerations . Alternatively , our findings of no difference in perineal lacerations suggest that delivering in bed without stirrups confers no advantages or disadvantages Abstract Objective : Dianatal ® is a bioadhesive gliding film which reduces the opposing force to vaginal childbirth . We aim ed to investigate the safety , applicability , and impact of Dianatal ® obstetric gel on second stage of labor and perineal integrity . Methods : Low-risk singleton pregnancies at term were prospect ively enrolled . Eligible women were r and omly assigned to either labor management without using obstetric gel , or labor management using intermittent application of obstetric gel into the birth canal during vaginal examinations , starting at active phase of labor ( ≥4 cm dilation ) . The primary measured outcome was the length of second stage of labor . Results : Overall , 200 cases were analyzed . Demographic , obstetrical , and labor characteristics were similar between the groups . Neither adverse events nor maternal or neonatal side effects were observed . The mean lengths of the active and second stages of labor were comparable between the obstetric gel-treated and the control groups ( 157 versus 219 min and 48 versus 56 min , respectively ) . None of the women had grade III/IV perineal tears . Maternal and neonatal outcomes were not negatively influenced by using obstetric gel . No difference was found after sub-group analysis for spontaneous vaginal delivery . Conclusion : Dianatal ® obstetric gel is safe in terms of maternal or neonatal use . Albeit a trend toward shorter labor stages using Dianatal ® obstetric gel , no significant differences were noted among the groups . In order to further investigate the influence of the obstetric gel on labor stage interval , perineal integrity and maternal and neonatal outcomes , larger r and omized clinical trials are needed to be carried out BACKGROUND Trauma to the perineum is a serious and frequent problem after childbirth , with about 350000 women each year in the UK needing sutures for perineal injury after spontaneous vaginal delivery , and many millions more worldwide . We compared the continuous technique of perineal repair with the interrupted method , and the more rapidly absorbed polyglactin 910 suture material with the st and ard polyglactin 910 material . METHODS 1542 women who had a spontaneous vaginal delivery with a second-degree perineal tear or episiotomy were r and omly allocated to either the continuous ( n=771 ) or interrupted ( 771 ) suturing method , and to either the more rapidly absorbed polyglactin 910 suture material ( 772 ) or st and ard polyglactin 910 material ( 770 ) . Primary outcomes were pain 10 days after delivery and superficial dyspareunia 3 months postpartum . Analysis was by intention to treat . FINDINGS At day 10 , three women had dropped out of the study . Significantly fewer women reported pain at 10 days with the continuous technique than with the interrupted method ( 204/770 [ 26.5 % ] vs 338/769 [ 44.0 % ] , odds ratio 0.47 , 95 % CI 0.38 - 0.58 , p<0.0001 ) . Occurrence of pain did not differ significantly between groups assigned the more rapidly absorbed material or st and ard material ( 256/769 [ 33.3 % ] vs 286/770 [ 37.1 % ] , 0.84 , 0.68 - 1.04 , p=0.10 ) . Women reported no difference in superficial dyspareunia at 3 months for the continuous vs the interrupted method ( 98/581 [ 16.9 % ] vs 102/593 [ 17.2 % ] , 0.98 , 0.72 - 1.33 , p=0.88 ) or the more rapidly absorbed versus st and ard material ( 1
Output:
| Episiotomy was more frequent in the h and s-on group ( average RR 0.58 , 95 % CI 0.43 to 0.79 , Tau² 0.07 , I² 74 % , four studies , 7247 women ; low- quality evidence ) , but there was considerable heterogeneity between the four included studies .There were no data for perineal trauma requiring suturing .
Other comparisonsThe delivery of posterior versus anterior shoulder first , use of a perineal protection device , different oils/wax , and cold compresses did not show any effects on perineal outcomes .
Moderate- quality evidence suggests that warm compresses , and massage , may reduce third- and fourth-degree tears but the impact of these techniques on other outcomes was unclear or inconsistent .
Poor- quality evidence suggests h and s-off techniques may reduce episiotomy , but this technique had no clear impact on other outcomes . |
MS212912 | ***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 To determine the contribution of bone mineral density ( BMD ) to breast cancer risk relative to other established breast cancer risk factors in postmenopausal women with osteoporosis . Methods Data for this analysis comprised those collected from women r and omized to placebo in the MORE and CORE trials ( N = 2,576 ) . Risk factors measured at baseline included age , family history of breast cancer , estradiol level , body mass index , prior hormone therapy , BMD and vertebral fracture status . Cox proportional hazards regression models were used to calculate the hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) . Results Over a total of 13,698 woman-years of follow-up , 65 incident breast cancers occurred . In univariate analyses , older age and family history of breast cancer were the strongest predictors of breast cancer risk , associated with a 2.4- and 2.6-fold increase in breast cancer incidence . A higher estradiol level was associated with a 1.9-fold increase in breast cancer incidence . The association between femoral neck BMD and breast cancer incidence was only significant after adjustment for age ( P = 0.03 ) . The final multivariable model included age , family history , estradiol , BMD , and the BMD-estradiol interaction since the effect of BMD on breast cancer varied by estradiol level ( interaction P-value , 0.04 ) ; in those with a lower estradiol level , a higher BMD was associated with a 2.6-fold increased in breast cancer . Conclusion Overall , BMD is a relatively weak predictor of breast cancer risk in these postmenopausal women with osteoporosis , after taking into consideration age , family history and endogenous estradiol level Study objective : Older women with high bone mineral density ( BMD ) have an increased risk of breast cancer but it is not well known whether this association is associated with the stage of the tumor . The objective of the study is to determine if older women with high BMD are likely to develop a more aggressive form of breast cancer , as defined by mortality . Patients : We prospect ively studied 1504 women who were 75 years of age or older at the entry in the study ( range , 75–90 years ) , between 1992 and 1994 . BMD was measured by dual-photon X-ray absorptiometry at three skeletal sites ( trochanter , Ward 's triangle , femoral neck ) . The women were followed for a mean of 7 years for the occurrence of breast cancer . Cox proportional-hazards models were used to obtain estimates of the relative risk of breast cancer and relative risk of death according to the BMD . Main results : Forty-five incident breast cancer cases were identified . In multivariate analyses of the risk of breast cancer for women in the highest tertile of BMD was greater than for women in the lowest tertile . Indeed , the women with a trochanter BMD in the highest tertile were at 2.3-fold increased risk compared with women in the lowest tertile . The women with highest tertile BMD measured at the Ward 's triangle and at the femoral neck were respectively at 2.2- and 3.3-fold increased risk compared with women at the lowest risk . The 7-year survival rates were markedly less favorable for women in the second and third tertile of the three skeletal sites compared with the lowest tertile . The risk of death was greater for women in the highest tertile of BMD than for women in the lowest tertile at every skeletal site . Conclusion : Elderly women with high BMD have an increased risk of breast cancer , especially advanced cancer , compared with women with low BMD A total of 489 elderly women aged 65 - 75 yr who participated in a 3-yr , r and omized , blinded osteoporosis trial underwent measurements of serum estradiol , bioavailable estradiol , and SHBG . At baseline , bone mineral density ( BMD ) was lower at the femoral sites ( 7 - 19 % , P < 0.05 ) , total body ( 6 - 8 % , P < 0.05 ) , and spine ( 5 - 9 % , P = 0.2 ) in women in the lowest tertile for serum total estradiol [ < 9 pg/ml ( 33 pmol/liter ) ] , serum bioavailable estradiol [ < 2.4 pg/ml ( 8.8 pmol/liter ) ] , or highest tertile for serum SHBG ( > 165 nmol/liter ) , compared with women in the highest tertiles of total estradiol [ > 13.3 pg/ml ( 49 pmol/liter ) ] and bioavailable estradiol [ > 4 pg/ml ( 14 pmol/liter ) ] or lowest tertile for SHBG ( < 113 nmol/liter ) . Bone markers were increased in women in the lowest tertile for serum total estradiol ( not significant ) and bioavailable estradiol ( P < 0.05 ) and highest tertile for SHBG ( P < 0.05 ) . In the longitudinal study , the rate of bone loss in the placebo group was significantly higher in total body ( P < 0.05 ) and spine ( P < 0.05 ) in women in the lowest tertile , compared with the highest tertile of serum bioavailable estradiol . After treatment with conjugated equine estrogens 0.625 mg/d , the increase in BMD was 4 - 6 % higher at the femoral sites ( P < 0.05 ) , total body ( P < 0.05 ) , and spine ( not significant ) , in the lowest tertile , compared with the highest tertile of serum bioavailable estradiol or highest tertile , compared with the lowest tertile of serum SHBG . In summary , small variations in endogenous serum estradiol and high serum SHBG determine differences in BMD and rate of bone loss in elderly women and also affect the response to treatment with estrogen . Women with a serum estradiol level of less than 9 pg/ml ( 33 pmol/liter ) are optimal c and i date s for estrogen therapy for osteoporosis prevention ABSTRACT Objective : To evaluate the relationship between bone mass and risk of breast cancer and to determine the effect of raloxifene therapy on breast cancer incidence in women categorized by bone mass into low bone mass and osteoporosis subgroups . Design : In this post hoc analysis , data were analyzed from the Multiple Outcomes of Raloxifene Evaluation ( MORE ) trial , enrolling postmenopausal women with low bone mass ( N = 7705 ) , and the Continuing Outcomes Relevant to Evista ( CORE ) trial , a follow-up to MORE enrolling 4011 MORE participants . Total follow-up was for up to 8 years . Women with a total hip bone mineral density ( BMD ) T-score < –1 to > –2.5 or T-score ≤ –2.5 ( referent , NHANES III data base ) were classified as having low bone mass or osteoporosis , respectively . Women with a pre-existing vertebral fracture were considered as having osteoporosis irrespective of BMD T-score . Analyses were performed for invasive breast cancers and invasive estrogen-receptor ( ER ) positive breast cancers . Results : Women with low bone mass ( N = 3829 ) had a twofold higher incidence of invasive ER-positive breast cancer than those with osteoporosis ( N = 3836 ) ( HR 2.13 , 95 % CI 1.12–4.03 ) . The incidence of all invasive breast cancers did not differ significantly between the bone mass groups . The incidences of invasive and invasive ER-positive breast cancers were 65–78 % lower in women assigned raloxifene versus placebo in both the low bone mass and osteoporosis groups ( p < 0.05 ) . Conclusions : In this post hoc analysis of postmenopausal women participating in MORE and CORE , bone mass was a predictor of invasive ER-positive breast cancer . Raloxifene treatment reduced the risk of invasive and invasive ER-positive breast cancers in women with low bone mass and those with osteoporosis . Since participants were older postmenopausal women with low bone mass , whether these findings can be generalized to other postmenopausal women is unclear Summary In this prospect i ve study in 2,137 perimenopausal and early postmenopausal women who were followed over a 13.1-year period of time , we observed no association between bone mineral density measured at the beginning of menopause and the subsequent risk of breast cancer . Introduction This study aim ed to investigate the relationship between BMD and the risk of breast cancer ( BC ) in young postmenopausal women . Methods As part of a clinical research program , 2,137 women who were perimenopausal or within their 5 first postmenopausal years were scanned between 1988–1990 and review ed on average 13.1 years after their initial examination . Ninety-eight incident BC cases were recorded throughout the follow-up . Results Women with incident BC significantly differed from those who had never had BC with regard to age at menarche , age of birth of 1st child , familial history of BC and postmenopausal hormone therapy ( PHT ) use . There was no significant difference between the two groups for baseline DXA of the spine . There was a trend for BC cases for having lower femoral neck BMD compared to women without BC . However , women with low BMD were more likely to have taken PHT by the end of the study . In Cox multivariate analyses the relationship between BC risk and femoral neck BMD no longer existed . Conclusions There was no relationship between BMD measured within the first postmenopausal years and the risk of BC , which makes unlikely the possibility of using BMD as a predictor factor for BC in early postmenopausal women OBJECTIVE To test the hypothesis that bone mineral density ( BMD ) is associated with the risk of developing breast cancer in older women . DESIGN Prospect i ve cohort study with mean ( SD ) follow-up of 3.2 ( 1.6 ) years . SETTING Four clinical centers , one each located in the following areas : Baltimore , Md ; Minneapolis , Minn ; Portl and , Ore ; and the Monongahela Valley in Pennsylvania . PARTICIPANTS A total of 6854 nonblack women who were 65 years of age or older and enrolled in the Study of Osteoporotic Fractures . MEASUREMENTS Radius and calcaneus BMD by single photon absorptiometry at baseline ; hip and spine BMD by dual-energy x-ray absorptiometry 2 years later . MAIN OUTCOME MEASURE Breast cancer confirmed by medical record review . RESULTS A total of 97 women developed breast cancer . In the multivariate model , adjusting for age , the degree of obesity , and other important covariates , the risk of breast cancer was about 30 % to 50 % higher per 1 SD increase in BMD ( relative risk , distal radius BMD=1.50 ; 95 % confidence interval , 1.16 - 1.95 ) . The age-adjusted incidence rate of breast cancer per 1000 person-years among women in the lowest quartile of distal radius BMD was 2.46 , compared with 5.99 among women with the highest BMD . Women with BMD above the 25th percentile were at 2.0 to 2.5 times increased risk of breast cancer compared with women below the 25th percentile . Results were consistent across all BMD sites . CONCLUSIONS Bone mineral density predicts the risk of breast cancer in older women . The magnitude of the association is similar to that observed between BMD and all fractures . Our findings suggest a link between 2 of the most common conditions affecting a woman 's health . Identifying a common denominator for these conditions should substantially improve our underst and ing of their etiology and prevention Objective : This case – cohort study was design ed to examine whether total hip bone mineral density ( BMD ) is independently associated with breast cancer over and above its association with other determinants , including levels of total and bioavailable estradiol and testosterone and sex-hormone binding globulin . Methods : Our study population was selected from a cohort of 8203 postmenopausal women who were screened for the Fracture Intervention Trial in 1992 , at which time BMD was assessed , and blood sample s were obtained . A total of 109 women developed breast cancer during four years of follow-up ; 173 other r and omly selected women from the larger cohort were also selected . Cox proportional hazards with robust variance adjustment was used for these analyses . Results : Relative to women in the lower fourth of the BMD distribution , the risk associated with being in the upper fourth was 2.6 ( 95 % confidence interval ( CI ) 1.1–5.8 ) . After adjusting for serum hormone levels , the corresponding relative risk was 2.5 ( 95 % CI 0.9–5.2 ) . With body mass index and number of years since menopause added to the multivariate analysis , the relative risk decreased to 1.4 ( 95 % CI 0.5–4.0 ) . Conclusions : BMD may not influence breast cancer risk independent of its relationship with endogenous hormones and measured covariates
Output:
| Furthermore , the results of the dose – response analysis did not show a significant association between BMD at the lumbar spine , femoral neck , or total hip and the risk of BC .
Conclusion There is no relationship between BMD and the risk of BC . |
MS212913 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE Programmed death-1 ( PD-1 ) , an inhibitory receptor expressed on activated T cells , may suppress antitumor immunity . This phase I study sought to determine the safety and tolerability of anti-PD-1 blockade in patients with treatment-refractory solid tumors and to preliminarily assess antitumor activity , pharmacodynamics , and immunologic correlates . PATIENTS AND METHODS Thirty-nine patients with advanced metastatic melanoma , colorectal cancer ( CRC ) , castrate-resistant prostate cancer , non-small-cell lung cancer ( NSCLC ) , or renal cell carcinoma ( RCC ) received a single intravenous infusion of anti-PD-1 ( MDX-1106 ) in dose-escalating six-patient cohorts at 0.3 , 1 , 3 , or 10 mg/kg , followed by a 15-patient expansion cohort at 10 mg/kg . Patients with evidence of clinical benefit at 3 months were eligible for repeated therapy . RESULTS Anti-PD-1 was well tolerated : one serious adverse event , inflammatory colitis , was observed in a patient with melanoma who received five doses at 1 mg/kg . One durable complete response ( CRC ) and two partial responses ( PRs ; melanoma , RCC ) were seen . Two additional patients ( melanoma , NSCLC ) had significant lesional tumor regressions not meeting PR criteria . The serum half-life of anti-PD-1 was 12 to 20 days . However , pharmacodynamics indicated a sustained mean occupancy of > 70 % of PD-1 molecules on circulating T cells > or = 2 months following infusion , regardless of dose . In nine patients examined , tumor cell surface B7-H1 expression appeared to correlate with the likelihood of response to treatment . CONCLUSION Blocking the PD-1 immune checkpoint with intermittent antibody dosing is well tolerated and associated with evidence of antitumor activity . Exploration of alternative dosing regimens and combinatorial therapies with vaccines , targeted therapies , and /or other checkpoint inhibitors is warranted Therapies that target the programmed death-1 ( PD-1 ) receptor have shown unprecedented rates of durable clinical responses in patients with various cancer types . One mechanism by which cancer tissues limit the host immune response is via upregulation of PD-1 lig and ( PD-L1 ) and its ligation to PD-1 on antigen-specific CD8 + T cells ( termed adaptive immune resistance ) . Here we show that pre-existing CD8 + T cells distinctly located at the invasive tumour margin are associated with expression of the PD-1/PD-L1 immune inhibitory axis and may predict response to therapy . We analysed sample s from 46 patients with metastatic melanoma obtained before and during anti-PD-1 therapy ( pembrolizumab ) using quantitative immunohistochemistry , quantitative multiplex immunofluorescence , and next-generation sequencing for T-cell antigen receptors ( TCRs ) . In serially sample d tumours , patients responding to treatment showed proliferation of intratumoral CD8 + T cells that directly correlated with radiographic reduction in tumour size . Pre-treatment sample s obtained from responding patients showed higher numbers of CD8- , PD-1- and PD-L1-expressing cells at the invasive tumour margin and inside tumours , with close proximity between PD-1 and PD-L1 , and a more clonal TCR repertoire . Using multivariate analysis , we established a predictive model based on CD8 expression at the invasive margin and vali date d the model in an independent cohort of 15 patients . Our findings indicate that tumour regression after therapeutic PD-1 blockade requires pre-existing CD8 + T cells that are negatively regulated by PD-1/PD-L1-mediated adaptive immune resistance BACKGROUND Results from phase 2 and 3 trials in patients with advanced melanoma have shown significant improvements in the proportion of patients achieving an objective response and prolonged progression-free survival with the combination of nivolumab ( an anti-PD-1 antibody ) plus ipilimumab ( an anti-CTLA-4 antibody ) compared with ipilimumab alone . We report 2-year overall survival data from a r and omised controlled trial assessing this treatment in previously untreated advanced melanoma . METHODS In this multicentre , double-blind , r and omised , controlled , phase 2 trial ( CheckMate 069 ) we recruited patients from 19 specialist cancer centres in two countries ( France and the USA ) . Eligible patients were aged 18 years or older with previously untreated , unresectable stage III or IV melanoma and an Eastern Cooperative Oncology Group performance status of 0 or 1 . Patients were r and omly assigned 2:1 to receive an intravenous infusion of nivolumab 1 mg/kg plus ipilimumab 3 mg/kg or ipilimumab 3 mg/kg plus placebo , every 3 weeks for four doses . Subsequently , patients assigned to nivolumab plus ipilimumab received nivolumab 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity , whereas patients allocated to ipilimumab alone received placebo every 2 weeks during this phase . R and omisation was done via an interactive voice response system with a permuted block schedule ( block size of six ) and stratification by BRAF mutation status . The study funder , patients , investigators , and study site staff were masked to treatment assignment . The primary endpoint , which has been reported previously , was the proportion of patients with BRAFV600 wild-type melanoma achieving an investigator-assessed objective response . Overall survival was an exploratory endpoint and is reported in this Article . Efficacy analyses were done on the intention-to-treat population , whereas safety was assessed in all treated patients who received at least one dose of study drug . This study is registered with Clinical Trials.gov , number NCT01927419 , and is ongoing but no longer enrolling patients . FINDINGS Between Sept 16 , 2013 , and Feb 6 , 2014 , we screened 179 patients and enrolled 142 , r and omly assigning 95 patients to nivolumab plus ipilimumab and 47 to ipilimumab alone . In each treatment group , one patient no longer met the study criteria following r and omisation and thus did not receive study drug . At a median follow-up of 24·5 months ( IQR 9·1 - 25·7 ) , 2-year overall survival was 63·8 % ( 95 % CI 53·3 - 72·6 ) for those assigned to nivolumab plus ipilimumab and 53·6 % ( 95 % CI 38·1 - 66·8 ) for those assigned to ipilimumab alone ; median overall survival had not been reached in either group ( hazard ratio 0·74 , 95 % CI 0·43 - 1·26 ; p=0·26 ) . Treatment-related grade 3 - 4 adverse events were reported in 51 ( 54 % ) of 94 patients who received nivolumab plus ipilimumab compared with nine ( 20 % ) of 46 patients who received ipilimumab alone . The most common treatment-related grade 3 - 4 adverse events were colitis ( 12 [ 13 % ] of 94 patients ) and increased alanine aminotransferase ( ten [ 11 % ] ) in the combination group and diarrhoea ( five [ 11 % ] of 46 patients ) and hypophysitis ( two [ 4 % ] ) in the ipilimumab alone group . Serious grade 3 - 4 treatment-related adverse events were reported in 34 ( 36 % ) of 94 patients who received nivolumab plus ipilimumab ( including colitis in ten [ 11 % ] of 94 patients , and diarrhoea in five [ 5 % ] ) compared with four ( 9 % ) of 46 patients who received ipilimumab alone ( including diarrhoea in two [ 4 % ] of 46 patients , colitis in one [ 2 % ] , and hypophysitis in one [ 2 % ] ) . No new types of treatment-related adverse events or treatment-related deaths occurred in this up date d analysis . INTERPRETATION Although follow-up of the patients in this study is ongoing , the results of this analysis suggest that the combination of first-line nivolumab plus ipilimumab might lead to improved outcomes compared with first-line ipilimumab alone in patients with advanced melanoma . The results suggest encouraging survival outcomes with immunotherapy in this population of patients . FUNDING Bristol-Myers Squibb BACKGROUND Limited evidence exists to show that adding a third agent to platinum-doublet chemotherapy improves efficacy in the first-line advanced non-small-cell lung cancer ( NSCLC ) setting . The anti-PD-1 antibody pembrolizumab has shown efficacy as monotherapy in patients with advanced NSCLC and has a non-overlapping toxicity profile with chemotherapy . We assessed whether the addition of pembrolizumab to platinum-doublet chemotherapy improves efficacy in patients with advanced non-squamous NSCLC . METHODS In this r and omised , open-label , phase 2 cohort of a multicohort study ( KEYNOTE-021 ) , patients were enrolled at 26 medical centres in the USA and Taiwan . Patients with chemotherapy-naive , stage IIIB or IV , non-squamous NSCLC without targetable EGFR or ALK genetic aberrations were r and omly assigned ( 1:1 ) in blocks of four stratified by PD-L1 tumour proportion score ( < 1 % vs ≥1 % ) using an interactive voice-response system to 4 cycles of pembrolizumab 200 mg plus carboplatin area under curve 5 mg/mL per min and pemetrexed 500 mg/m2 every 3 weeks followed by pembrolizumab for 24 months and indefinite pemetrexed maintenance therapy or to 4 cycles of carboplatin and pemetrexed alone followed by indefinite pemetrexed maintenance therapy . The primary endpoint was the proportion of patients who achieved an objective response , defined as the percentage of patients with radiologically confirmed complete or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1 assessed by masked , independent central review , in the intention-to-treat population , defined as all patients who were allocated to study treatment . Significance threshold was p<0·025 ( one sided ) . Safety was assessed in the as-treated population , defined as all patients who received at least one dose of the assigned study treatment . This trial , which is closed for enrolment but continuing for follow-up , is registered with Clinical Trials.gov , number NCT02039674 . FINDINGS Between Nov 25 , 2014 , and Jan 25 , 2016 , 123 patients were enrolled ; 60 were r and omly assigned to the pembrolizumab plus chemotherapy group and 63 to the chemotherapy alone group . 33 ( 55 % ; 95 % CI 42 - 68 ) of 60 patients in the pembrolizumab plus chemotherapy group achieved an objective response compared with 18 ( 29 % ; 18 - 41 ) of 63 patients in the chemotherapy alone group ( estimated treatment difference 26 % [ 95 % CI 9 - 42 % ] ; p=0·0016 ) . The incidence of grade 3 or worse treatment-related adverse events was similar between groups ( 23 [ 39 % ] of 59 patients in the pembrolizumab plus chemotherapy group and 16 [ 26 % ] of 62 in the chemotherapy alone group ) . The most common grade 3 or worse treatment-related adverse events in the pembrolizumab plus chemotherapy group were anaemia ( seven [ 12 % ] of 59 ) and decreased neutrophil count ( three [ 5 % ] ) ; an additional six events each occurred in two ( 3 % ) for acute kidney injury , decreased lymphocyte count , fatigue , neutropenia , and sepsis , and thrombocytopenia . In the chemotherapy alone group , the most common grade 3 or worse events were anaemia ( nine [ 15 % ] of 62 ) and decreased neutrophil count , pancytopenia , and thrombocytopenia ( two [ 3 % ] each ) . One ( 2 % ) of 59 patients in the pembrolizumab plus chemotherapy group experienced treatment-related death because of sepsis compared with two ( 3 % ) of 62 patients in the chemotherapy group : one because of sepsis and one because of pancytopenia . INTERPRETATION Combination of pembrolizumab , carboplatin , and pemetrexed could be an effective and tolerable first-line treatment option for patients with advanced non-squamous NSCLC . This finding is being further explored in an ongoing international , r and omised , double-blind , phase 3 study . FUNDING Merck & BACKGROUND Atezolizumab is a humanised antiprogrammed death-lig and 1 ( PD-L1 ) monoclonal antibody that inhibits PD-L1 and programmed death-1 ( PD-1 ) and PD-L1 and B7 - 1 interactions , reinvigorating anticancer immunity . We assessed its efficacy and safety versus docetaxel in previously treated patients with non-small-cell lung cancer . METHODS We did a r and omised , open-label , phase 3 trial ( OAK ) in 194 academic or community oncology centres in 31
Output:
| Conclusion : The incidence risk of diarrhea associated with PD-1/-PD-L1 inhibitor monotherapy was significantly lower than that of docetaxel monotherapy group .
However it was higher in PD-1/PD-L1 inhibitor combined with chemotherapy group compared with the chemotherapy alone group |
MS212914 | ***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 The time to antibiotic administration ( TTA ) has been proposed as a quality -of-care measure in febrile neutropenia ( FN ) ; however , few data regarding the impact of the TTA on the mortality of adult cancer patients with FN are available . The objective of this study was to determine whether the TTA is a predictor of mortality in adult cancer patients with FN . A prospect i ve cohort study of all consecutive cases of FN , evaluated from October 2009 to August 2011 , at a single tertiary referral hospital in southern Brazil was performed . The TTA was assessed as a predictive factor for mortality within 28 days of FN onset using the Cox proportional hazards model . Kaplan-Meier curves were used for an assessment of the mortality rates according to different TTAs ; the log-rank test was used for between-group comparisons . In total , 307 cases of FN ( 169 subjects ) were evaluated . During the study period , there were 29 deaths . In a Cox regression analysis , the TTA was independently associated with mortality within 28 days ( hazard ratio [ HR ] , 1.18 ; 95 % confidence interval [ CI ] , 1.10 to 1.26 ) ; each increase of 1 h in the TTA raised the risk of mortality within 28 days by 18 % . Patients with FN episodes with a TTA of ≤30 min had lower 28-day mortality rates than those with a TTA of between 31 min and 60 min ( 3.0 % versus 18.1 % ; log-rank P = 0.0002 ) . Early antibiotic administration was associated with higher survival rates in the context of FN . Efforts should be made to ensure that FN patients receive effective antibiotic therapy as soon as possible . A target of 30 min to the TTA should be adopted for cancer patients with FN Background : Early administration of antimicrobial ( AM ) is relevant in children with cancer , fever and neutropenia ( FN ) . The recommendation is to administer the first dose of AM within the first hour of hospital admission . Our aims were to determine the time from the moment that a child with FN is admitted to the hospital until they receive their first dose of AM and to determine the association with clinical outcomes . Methods : This prospect i ve , multicenter study evaluated the time elapsed from the admission to the first dose of AM , comparing this variable by admitting hospital and presentation location ( Emergency Department/Oncology Units ) and evaluating the clinical outcomes by the following variables : days of fever , days of hospitalization , hypotension , transfer to intensive care unit , sepsis and mortality . Results : A total of 226 children with 388 episodes of FN were enrolled from 5 hospitals ( July 2012–April 2014 ) . The median time between hospital admission and administration of the first dose of AM was 132 minutes ( interquartile range : 60–246 minutes ) . The median time to AM administration was significantly different between hospitals ( 70 vs. 200 minutes , P < 0.0001 ) and between presentation locations ( Emergency Department vs. Oncology Units , median : 200 vs. 100 minutes , P < 0.0001 ) . Twenty-five percentage of children received AM within 1 hour of admission . The administration of AM after 60 minutes was not associated with worse outcomes . Conclusions : Time to AM administration was longer than the recommendation . The findings described provide an opportunity to identify gaps and implement programs aim ed at improving the equity and excellence of care in children with cancer and FN Background Antibiotic delivery to patients with fever and neutropenia ( F&N ) in < 60 min is an increasingly important quality measure for oncology centers , but several published reports indicate that a time to antibiotic delivery ( TTA ) of < 60 min is quite difficult to achieve . Here we report a quality improvement ( QI ) effort that sought to decrease TTA and assess associated clinical outcomes in pediatric patients with cancer and F&N. Procedure We used Lean- Methodology and a Plan-Do- Study -Act approach to direct QI efforts and prospect ively tracked TTA measures and associated clinical outcomes ( length of stay , duration of fever , use of imaging studies to search for occult infection , bacteremia , intensive care unit ( ICU ) consultation or admission , and mortality ) . We then performed statistical analysis to determine the impact of our QI interventions on total TTA , sub-process times , and clinical outcomes . Results Our QI interventions significantly improved TTA such that we are now able to deliver antibiotics in < 60 min nearly 100 % of the time . All TTA sub-process times also improved . Moreover , achieving TTA < 60 min significantly reduced the need for ICU consultation or admission ( P = 0.003 ) in this population . Conclusion Here we describe our QI effort along with a detailed assessment of several associated clinical outcomes . These data indicate that decreasing TTA to < 60 min is achievable and associated with improved outcomes in pediatric patients with cancer and 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 Children with cancer and fever are at high risk for sepsis related death . Rapid antibiotic delivery ( < 60 minutes ) has been shown to reduce mortality . We compared patient outcomes and describe interventions from three separate quality improvement ( QI ) projects conducted in three United States ( US ) tertiary care pediatric emergency departments ( EDs ) with the shared aim to reduce time to antibiotic ( TTA ) to < 60 minutes in febrile pediatric oncology patients ( Temperature > 38.0 C ) . A secondary objective was to identify interventions amenable to translation to other centers . We conducted a post project analysis of prospect ively collected observational data from children < 18 years visiting these EDs during independently conducted QI projects . Comparisons were made pre to post intervention periods within each institution . All interventions were derived independently using QI methods by each institution . Successful as well as unsuccessful interventions were described and common interventions adopted by all sites identified . A total of 1032 ED patient visits were identified from the three projects . Improvement in median TTA delivery ( min ) pre to post intervention(s ) was 118.5–57.0 at site 1 , 163.0–97.5 at site 2 , and 188.0–111.5 at site 3 ( p<.001 all sites ) . The eight common interventions were 1 ) Triage application of topical anesthetic 2 ) Rapid room placement & triage 3 ) Resuscitation room placement of ill appearing children 4 ) Close proximity to central line equipment 5 ) Antibiotic administration before laboratory analyses 6 ) Consensus clinical practice guideline establishment 7 ) Family pre-ED education for fever and 8) Staff project up date s. This core set of eight low cost , high yield QI interventions were developed independently by the three ED 's which led to substantial reduction in time to antibiotic delivery in children with cancer presenting with fever . These interventions may inform future QI initiatives in other setting s caring for febrile pediatric oncology patients PURPOSE Febrile neutropenia ( FN ) is an oncologic emergency , and prolonged time to antibiotic administration ( TTA ) is associated with increased hospital length of stay ( LOS ) and worse outcomes . We hypothesized that a febrile neutropenia pathway ( FNP ) quality initiative project would reduce TTA delays for febrile patients with cancer presenting to the emergency department ( ED ) . METHODS This prospect i ve study compared ED FNP patients ( > 18 years old ) , between June 2012 and June 2013 with both historical and direct admissions ( DA ) cohorts at a multispecialty academic center . Interventions included providing patients with FN-Alert cards , st and ardizing the definition of FN and recognizing it as a distinct chief complaint , revising ED triage level for FN , creating electronic FN order sets , administering empiric antibiotics before neutrophil count result , and relocating FN antibiotics to the ED . The primary outcome was TTA , with a target goal of 90 minutes after ED presentation . RESULTS In total , 276 FN episodes in 223 FNP patients occurred over the 12-month study period and were compared with 107 episodes in 87 patients and 114 episodes in 101 patients in the historical and DA cohorts , respectively . Use of the FNP reduced TTA from 235 and 169 minutes in historical and DA cohorts , respectively , to 81 minutes , and from 96 to 68 minutes when the order set was not used versus used in the FNP group ( P < .001 for all comparisons ) . Decrease in hospital LOS was not statistically significant . CONCLUSION The ED FNP is a significant quality initiative with sustainable interventions , and was able to demonstrate value by decreasing TTA compared to both historical and DA controls in cancer patients presenting to the ED BACKGROUND Time-to-antibiotic ( TTA ) administration is a widely used quality -of-care measure for children with cancer and febrile neutropenia ( FN ) . We sought to determine whether TTA is associated with outcomes of FN . PROCEDURE A single-center , retrospective cohort study was conducted of 1,628 FN admissions from 653 patients from 2001 to 2009 . Outcome variables included ( 1 ) an adverse event ( AE ) composite of in-hospital mortality , pediatric intensive care unit ( PICU ) admission within 24 hours of presentation , and /or fluid resuscitation ≥ 40 ml/kg within 24 hours of presentation and ( 2 ) length of stay ( LOS ) . TTA was measured as a continuous variable and in 60-minute intervals . Mixed regression models were constructed to evaluate associations of TTA with the outcome variables after adjusting for relevant covariates including cancer diagnosis , degree of myelosuppression , and presence of bacteremia . RESULTS The composite AE outcome occurred in 11.1 % of admissions including 0.7 % in-hospital mortality , 4.7 % PICU admission , and 10.1 % fluid resuscitation . In univariate analysis , TTA was associated with the composite AE outcome ( Odds Ratio [ OR ] 1.29 , 95 % CI 1.02 - 1.64 ) but not LOS . In multivariate analysis , after adjustment for relevant covariates , 60-minute TTA intervals were associated with the composite AE outcome ( 61 - 120 minutes vs. ≤ 60 minutes , OR 1.81 , 95 % CI 1.01 - 3.26 ) . Unexpectedly , admission from the emergency department ( ED ) was also independently associated with the composite AE outcome ( ED vs. clinic , OR 3.15 , 95 % CI 1.95 - 5.09 ) . CONCLUSIONS TTA and presentation to the ED are independently associated with poor outcomes of FN Objectives Patients with febrile neutropenia are at high risk of morbidity and mortality from infectious causes . Decreasing time to antibiotic ( TTA ) administration is associated with improved patient outcomes . We sought to reduce TTA for children presenting to the emergency department with fever and neutropenia . Methods In a prospect i ve cohort study with historical comparison , TTA administration was evaluated in patients with neutropenia presenting to the Children 's of Alabama Emergency Department . A protocol was established to reduce delays in antibiotic administration and increase the percentage of patients who receive treatment within 60 minutes of presentation . One hundred pre- protocol patient visits between August 2010 and December 2011 were evaluated and 153 post- protocol visits were evaluated between August 2012 and September 2013 . We review ed individual cases to determine barriers to rapid antibiotic administration . Results Antibiotics were administered in 96.9 ± 57.8 minutes in the pre- protocol patient group , and only 35 % of patients received antibiotics within 60 minutes of presentation and 70 % received antibiotics within 120 minutes . After implementation of the protocol , TTA for neutropenic patients was decreased to 64.3 ± 28.4 minutes ( P < 0.0001 ) with 51.4 % receiving antibiotics within 60 minutes and 93.2 % within 120 minutes . Conclusions Implementing a st and ard approach to patients at risk for neutropenia decreased TTA . There are numerous challenges in providing timely antibiotics to children with febrile neutropenia . Identified delays included venous access ( time to effect of topical anesthetics , and difficulty obtaining access ) , physicians waiting on laboratory results , and antibiotic availability BACKGROUND Fever and chemotherapy-induced neutropenia ( FN ) is the most frequent potentially lethal complication of therapy in children with cancer . This study aim ed to describe serious medical complications ( SMC ) in children with FN regarding incidence , clinical spectrum , and associated characteristics . PROCEDURE Pediatric patients presenting with FN induced by non-myeloablative chemotherapy were observed in a prospect i ve multicenter study . SMC was defined as potentially life-threatening complication ( PLTC ) , transfer to the pediatric intensive care unit ( PICU ) , or death . RESULTS A total of 443 FN episodes were reported from 8 centers .
Output:
| This review supports the assertion that TTA can be considered a measure of quality of care , emphasizes the importance of education and training , and describes the very different interventions which have effectively reduced TTA |
MS212915 | ***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: 1 . Shackelford GD . Neurosonography of hydrocephalus in infants . Neuroradiology 1986;28:452 - 62 . 2 . Levene MI . Measurement of the growth of the lateral ventricles in preterm infants with real-time ultrasound . Arch Dis Child 1981 ; 56i900 - 4 . 3 . Johnson ML , Mack LA , Rumaek CM , et al. B-mode echoencephalography inthe normal and high risk infant . A JR Am J Roentgenol 1979;133:374 - 81 . 4 . Rumack CM , Johnson ML . Perinatal and infant brain imaging . Chicago : Year Book Medical Publishers , 1984:157 . 5 . Brann BS , Wofsy C , Wicks J , Brayer J. The quantification of neonatal cerebral ventricular volume by real-time ultrasonography : derivation and in vitro confirmation of a mathematical model . J Ultrasound Med 1990;9:1 - 8 . 6 . Brann BS , Wofsy C , Papile LA , Angelus P , Backstrom C. The quantification of neonatal cerebral ventricular volume by realtime ultrasonography : in vivo validation of the cylindrical coordinate method . J Ultrasound Med 1990;9:9 - 15 . 7 . Garrett W J , Kossoff G , Warren PS . Cerebral ventricular size in children : a two-dimensional ultrasonic study . Radiology 1980 ; 136:711 - 5 . 8 . London DA , Carroll BA , Enzmann DR . Sonography of ventricular size and germinal matrix hemorrhage in premature infants . AJNR 1980;1:295 - 300 . 9 . Sauerbrei EE , Digney M , Harrison PB , Cooperberg PL . Ultrasonic evaluation of neonatal intracranial hemorrhage and its complications . Radiology 1981 ; 39:667 - 85 . 10 . Quisling RG , Reeder JD , Setzer ES , Kaude JV . Temporal comparative analysis of computed tomography with ultrasound for intracranial hemorrhage in premature infants . Neuroradiology 1983;24:205 - 11 . 11 . Naidich TP , Epstein F , Lin JP , Kricheff II , Hochwald GM . Evaluation Of pediatric hydrocephalus by computed tomography . Radiology 1976;119:337 - 45 . 12 . Hertzberg BS , Bowie JD , Burger PC , Marshburn PB , Djang WT . The th?ee lines : origin of sonographic l and marks in the fetal head . A JR Am J Roentgenol 1987;149:1009 - 12 . 13 . Hakim S , Adams RD . The special clinical problem of symptomatic hydrocephalus with normal cerebrospinal fluid pressure . J Neurol Sci 1965;2:307 - 27 . 14 . Geschwind N. The mechanism of normal pressure hydrocephalus . J Neurol Sci 1968;7:481 - 93 . 15 . Nagashima T , Tamaki N , Matsumoto S , Horwitz B , Seguchi Y. Biomechanics of hydrocephalus : a new theoretical model . Neurosurgery 1987;21:898 - 904 As a result of r and omized assignment , 15 preterm infants weighing 1,500 gm or less at birth and who had a symptomatic PDA were treated according to a medical management protocol , and ten according to an early surgical closure protocol . All infants required mechanical ventilation at the time of study entry , which was one week after birth . Birth weight , gestational age , age at onset of congestive failure , age at study entry , and the initial morbidity of members of the two groups were similar . The nine surviving infants managed according to the surgical closure protocol were weaned from mechanical ventilation sooner , had a decreased need for digoxin and furosemide , achieved gastrointestinal function sooner , and had a smaller hospital bill than the 12 survivors of the medical management group . These results indicate that infants with a symptomatic PDA still requiring mechanical ventilation at one week after birth will benefit from surgical closure of the ductus at that time AIM To evaluate the efficiency and side effects of ibuprofen for the early treatment of patent ductus arteriosus ( PDA ) and compare it with indomethacin . METHODS Forty preterm infants with gestational ages of less than 33 weeks , with respiratory distress syndrome ( RDS ) and echocardiographically confirmed PDA , were r and omly assigned at days 2 to 3 of life to receive either intravenous indomethacin 3 × 0.2 mg/kg at 12 hour intervals or intravenous ibuprofen 1 × 10 mg/kg , followed by 5 mg/kg 24 and 48 hours later . RESULTS PDA closed in 15 of 20 patients from the indomethacin group ( 75 % ) and in 16 of 20 ( 80 % ) from the ibuprofen group . Seven patients ( three indomethacin , four ibuprofen ) required a second treatment with indomethacin and in five ( three in the indomethacin group and two in the ibuprofen group ) the duct was ultimately ligated . Ibuprofen patients had a better urinary output and showed no increase in serum creatinine concentrations compared with the indomethacin group . Ibuprofen was not associated with any other side effect . CONCLUSIONS Ibuprofen treatment seems to be as efficient as indomethacin in closing PDA on the third day of life in preterm infants with respiratory distress syndrome and seems to have fewer renal side effects We admitted 36 preterm neonates ( 600 to 1250 gm birth weight ) with normal 6-hour echoencephalograms to a r and omized , placebo-controlled prospect i ve trial to determine whether a low dose of indomethacin would prevent germinal matrix or intraventricular hemorrhage and permit adequate urinary output . Between the sixth and tenth postnatal hours , indomethacin ( 0.1 mg/kg ) or placebo was administered intravenously every 24 hours for a total of three doses . Cardiac ultrasound studies to assess the status of the ductus arteriosus were performed at 6 postnatal hours and on day 5 . Urinary output , serum electrolytes , serum indomethacin levels , and renal and clotting functions were monitored . No differences in birth weight , gestational age , or Apgar scores were noted between the two groups of infants . Two indomethacin-treated infants and three infants given placebo had significant urinary output difficulties , requiring that the study medication be withheld . Of 19 infants given indomethacin , two had germinal matrix or intraventricular hemorrhage , in comparison with 8 of 17 infants given saline solution ( p = 0.02 ) . Of the infants who had a left-to-right patent ductus arteriosus shunt before treatment , 64 % of the indomethacin-treated and 33 % of the saline solution-treated infants no longer had a patent ductus arteriosus on day 5 . Ductal status appeared unrelated to the development of germinal matrix or intraventricular hemorrhage Objectives To determine patent ductus arteriosus ( PDA ) closure rates , and indomethacin ( INDO ) toxicity rates in neonates dosed with INDO using an individualized pharmacokinetic/pharmacodynamic ( PK/PD ) dosing approach . In addition , develop PD curves evaluating dose-response and concentration-response relationships for closure and renal toxicity , especially in select subgroups historically known as “ poor responders ” ( < 1000 g and ≥10 days postnatal age ) . Design Prospect i ve , cohort study . Setting Level III neonatal intensive care unit . Subjects One hundred thirty-nine patients receiving 151 courses of INDO for PDA closure were evaluated . Interventions Patients initially received 0.25 mg/kg of INDO , followed immediately by 1 mg/kg of furosemide . INDO concentrations were obtained 2 hrs and 8 hrs after the dose and were assayed using high-performance liquid chromatography . Individualized PK parameters were calculated with subsequent INDO dosing based on the individualized PK variables to increase trough serum concentrations by 0.3–0.5 mg/L. Measurements and Main Results Ductal closure was successful in 127 patients ( 91 % ) . Renal toxicity occurred in 21 ( 15 % ) patients and was temporary and reversible . No significant differences in response rates based on treatment weight or postnatal age were observed . PD curves were similar for neonates < 1000 g vs. ≥1000 g. PD curves were also similar for neonates with postnatal age < 10 days vs. ≥10 days . Statistically significant differences were noted between neonates categorized for postnatal age < 10 days vs. ≥ 10 days in total days of therapy ( 1.8 vs. 2.3 days ) , total number of doses required to close PDA ( 3.5 vs. 5.6 doses ) , critical INDO dose ( 0.9 vs. 1.4 mg/kg ) , critical INDO concentration ( 1.9 vs. 1.4 mg/L ) , and critical dose/critical concentration ratio ( 0.52 vs. 2.2 ) . Conclusions These findings support the hypothesis that the poor PDA closure rates with INDO for neonates > 10 days postnatal age are the result of pharmacokinetic differences only and that weight does not impact response rates . Individualized pharmacokinetic/pharmacodynamic dosing of INDO continues to achieve higher closure rate than current dosing st and ards . Patients historically known as poor responders significantly benefit from this dosing approach In a r and omized study , indomethacin was administered either by an intravenous rapid infusion or by a 30-minute intravenous infusion to preterm infants . Ten infants were r and omly assigned to the rapid infusion group and nine to the other group . Time-averaged mean systolic , mean flow velocity , and mean diastolic blood flow velocities were measured in the internal carotid artery with a pulsed Doppler . Blood flow velocities , arterial blood gases , intraarterial blood pressures , and transcutaneous PO2 and PCO2 were measured at 5 and 1 minutes before indomethacin and then at 5 , 10 , 20 , 30 , 35 , 40 , 50 , 60 , and 90 minutes after indomethacin administration . Intravenous indomethacin either by rapid or slow infusion caused a significant decrease in the blood flow velocities . The blood flow velocities were significantly lower 5 minutes after rapid infusion and by 30 minutes in the slow-infusion group . In both groups , the blood flow velocities remained depressed up to 90 minutes . The blood pressures increased concomitantly to the blood flow velocities in the rapid-administration group only . Because indomethacin given for 30 minutes does not avoid the decrease in the blood flow velocities , further studies are necessary to ascertain the safest method of administration Abstract . Indomethacin ( INDO ) and , more recently , ibuprofen ( IBU ) have been used to treat haemodynamically significant patent ductus arteriosus ( PDA ) in preterm infants . Both are cyclo-oxygenase blockers , but seem to have a different influence on regional circulation . In a prospect i ve , r and omised , controlled study , we compared INDO and IBU with regard to efficacy and safety for the early non-invasive treatment of PDA . Doppler echocardiography was used to study 232 preterm infants ( gestational age 23–34 weeks ) with respiratory distress syndrome of whom 175 had persistent , haemodynamically significant PDA at 48–72 h of life . They were r and omised to receive three intravenous doses of either INDO ( 0.2 mg/kg , at 12 h intervals ) or IBU ( a first 10 mg/kg dose followed by two doses of 5 mg/kg at 24 h intervals ) , recording rate of ductal closure , need for additional treatment , side-effects and clinical course . The efficacy of the pharmacological treatment was similar in the two groups ( 56/81 , 69 % INDO ; 69/94 , 73 % IBU ) . Patients treated with INDO showed a significant increase in serum creatinine ( 89±24 versus 82±20 mmol/l , P=0.03 ) and a near-significant tendency for a lower fractional excretion of sodium ( 3±3 versus 4±2 % , P=0.08 ) ; moreover , 12/81 ( 15 % ) INDO patients versus 1/94 ( 1 % ) IBU patients became oliguric ( < 1 ml/kg per h ) during treatment ( P=0.017 ) . Conclusion : our findings confirm that , by comparison with indomethacin , ibuprofen has fewer effects on renal function in terms of urine output and fluid retention , with much the same efficacy and safety in closing patent ductus arteriosus in preterm infants with respiratory distress syndrome . In particular , no increased incidence of intracranial haemorrhage was observed after ibupro
Output:
| Analysis of these studies showed that , although the primary outcome of PDA closure on days two and five slightly favored bolus administration , there was no statistical difference between the two groups .
AUTHORS ' CONCLUSIONS Due to a paucity of events and lack of precision , the available data was found to be insufficient to draw conclusions regarding the efficacy of continuous indomethacin infusion versus bolus injections for the treatment of PDA .
Although continuous indomethacin seems to cause less alterations in cerebral , renal and mesenteric circulations , the clinical meaning of this effect is unclear . |
MS212916 | ***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 : With the psychiatric deinstitutionalization movement in its fourth decade , questions are being raised concerning its relevance for long-stay in patients with severe disabilities and the risk that those discharged into the community may be ab and oned . Methods A r and om sample taken in 1989 of long-stay in patients at Louis-H Lafontaine Hospital made it possible to examine 96 pairs of patients . Each pair included 1 patient discharged between 1989 and 1998 and 1 patient hospitalized . Pairs were matched for sex , age , length of stay , and level of psychiatric care in 1989 . Patients and staff were interviewed using st and ardized question naires , and case notes were review ed to assess symptoms , daily living skills , residential status , quality of residential setting , and clinical and social problems and needs . Results The investigation revealed that discharged patients moved to highly supervised setting s , which included professionally supervised group homes , supervised hostels , and foster families . About 20 % went to nursing homes owing to loss of autonomy from physical disorders . Only 4 discharged patients were lost to follow-up , of whom 2 were probable vagrants . Both those discharged and those remaining as in patients presented with major clinical problems and daily living skill deficits . The care needs of discharged patients were generally met , and placement in the community was considered appropriate . Of those who had remained hospitalized , over one-half could be moved to supervised setting s immediately , or after 1 to 2 years ' preparation in a discharge unit , while 13 % could be moved to nursing homes . Over 25 % required intensive , individualized rehabilitation treatment targeting engagement , psychotic symptoms , withdrawal , and dangerous and socially embarrassing behaviours . Conclusion Deinstitutionalization in the largest Canadian psychiatric hospital did not lead to patient ab and onment in the community Background Homelessness and mental illness have a strong association with public disorder and criminality . Experimental evidence indicates that Housing First ( HF ) increases housing stability and perceived choice among those experiencing chronic homelessness and mental disorders . HF is also associated with lower residential costs than common alternative approaches . Few studies have examined the effect of HF on criminal behavior . Methods Individuals meeting criteria for homelessness and a current mental disorder were r and omized to one of three conditions treatment as usual ( reference ) ; scattered site HF ; and congregate HF . Administrative data concerning justice system events were linked in order to study prior histories of offending and to test the relationship between housing status and offending following r and omization for up to two years . Results The majority of the sample ( 67 % ) was involved with the justice system , with a mean of 8.07 convictions per person in the ten years prior to recruitment . The most common category of crime was “ property offences ” ( mean = 4.09 ) . Following r and omization , the scattered site HF condition was associated with significantly lower numbers of sentences than treatment as usual ( Adjusted IRR = 0.29 ; 95 % CI 0.12–0.72 ) . Congregate HF was associated with a marginally significant reduction in sentences compared to treatment as usual ( Adjusted IRR = 0.55 ; 95 % CI : 0.26–1.14 ) . Conclusions This study is the first r and omized controlled trial to demonstrate benefits of HF among a homeless sample with mental illness in the domain of public safety and crime . Our sample was frequently involved with the justice system , with great personal and societal costs . Further implementation of HF is strongly indicated , particularly in the scattered site format . Research examining interdependencies between housing , health , and the justice system is indicated . Trial registration IS RCT OBJECTIVE In Upper Austria , a total of 409 long-stay patients were discharged to various residential facilities between 1995 and 2000 . This paper describes psychopathology and sociodemographic characteristics . METHODS A r and om sample of 116 former long-stay patients were followed for an average 42.9 months after discharge . RESULTS Patients had spent an average 19.3 years in psychiatric wards . 47 patients ( 40.5 % ) were placed in nursing homes , 16 patients ( 13.8 % ) in old-age homes , 32 patients ( 27.6 % ) in other institutions and only 15 patients ( 12.9 % ) in group homes , and 6 patients ( 5.2 % ) with families . ICD-10 diagnosis was schizophrenia in 56 patients ( 48.3 % ) and mental retardation in 33 patients ( 28.4 % ) . Level of social and functional disabilities was high . CONCLUSIONS Most long-stay patients were able to live outside psychiatric hospitals , but institutional care still plays an essential role BACKGROUND Long-stay patients with learning disabilities ( n = 214 ) were assessed in hospital and 12 and 24 months after discharge in order to examine the effects of relocation . METHOD Each resident acted as his/her own control in a prospect i ve repeated- measures design . Skills and behavioural problems were assessed by keyworkers . Self-perceived quality of life was obtained during interviews with research ers who also completed an environmental checklist of the residents ' accommodation . RESULTS There was little or no change in people 's low pre-discharge skill levels . Certain aspects of problem behaviour improved after 12 months , although socially unacceptable behaviour increased slightly . People were less depressed ( P < or = 0.01 ) 12 months after discharge ( N = 119 ) and were more satisfied ( P < or = 0.05 ) with their new ' homes ' ( n = 108 ) . There were few changes in the pattern of activities or the social networks of people 12 months later . Little or no further change in outcomes was reported 24 months after discharge . CONCLUSIONS The implementation of the deinstitutionalisation policy in Northern Irel and has been limited by the predominance of residential and nursing homes and the lack of ' ordinary ' accommodation . There is a need for purchasers and providers to give more attention to ways in which the principles of normalisation could be incorporated in the process of contracting and delivering services This paper review s briefly the history of mental health de population in Canada over the past 30 years . The term “ deinstitutionalization ” is often used but is unsatisfactory . Using an exploratory , qualitative , method ological approach , data were collected on the problems encountered by a disproportionate , stratified r and om sample of 139 formerly institutionalized patients living in various geographical locales in Eastern Canada . Adopting a symbolic interactionist theoretical approach , this study , in an effort to fill a neglect in the literature , attempted to discover what the everyday world(s ) of Canadian ex-mental patients was really like . Problems encountered related to stigma , poor housing , lack of back living skills , poverty , unemployment and aftercare . Quotations from patients are provided to illustrate such themes . The findings are discussed OBJECTIVES The purpose of this study was to evaluate effects associated with moving patients from hospital to community-based setting s , to compare persons who left the hospital with those who remained in the hospital , and to address the question of whether discharge reverses institutionalism in a sample of elderly long-stay psychiatric in patients . METHODS The hypotheses were that , compared with the control group of patients who stayed in the hospital , those who left would have significantly better mental states , social functioning , and social networks at follow-up ; that community setting s would provide a significantly better quality of environment than the hospital ; and that discharged patients would express a preference for community care after discharge from the hospital . The study was a prospect i ve nonr and omized controlled trial at Cane Hill , Friern , and Claybury Hospitals in Engl and . Sixty long-term patients with schizophrenia who were discharged to community care were compared over time with matched controls ( N=131 ) . RESULTS No overall differences were detected in the pattern or severity of symptoms between patients who were discharged from the hospital and those who were not , and no significant changes over time were noted . Significant improvements in social networks , patients ' preference for community setting s , and quality of clinical environment were noted . CONCLUSIONS These results give qualified support for moving long-stay psychiatric patients from hospital to community setting BACKGROUND The effects of hospital-based rehabilitation including weekly supportive psychodynamic therapy compared with specialized assertive intervention and st and ard treatment has not previously been investigated in first-episode psychosis . The aim of the study was to examine long-term effect on use of institutional care of different intensive interventions for patients with first-episode schizophrenia spectrum disorder on use of psychiatric bed days and days in supported housing . METHOD A total of 94 severely ill patients with first-episode schizophrenia spectrum disorders were included in a special part of the Copenhagen OPUS trial and r and omized to either the specialized assertive intervention program ( OPUS ) , st and ard treatment or hospital-based rehabilitation . RESULTS It was a stable pattern that patients r and omized to hospital-based rehabilitation spent more days in psychiatric wards and in supported housing throughout the 5-year follow-up period compared with the two other groups . Patients in OPUS treatment spent significantly fewer days in psychiatric wards and supported housing in the first 3 years compared with patients in hospital-based rehabilitation . Due to attrition and small sample size , differences in level of psychotic and negative symptoms at 5-year follow-up could not be evaluated . CONCLUSIONS The study indicates that hospital-based rehabilitation together with weekly supportive psychodynamic therapy was associated with a continued increased use of psychiatric bed days and days in supported housing . The data can not justify using hospital-based rehabilitation in first-episode psychosis Background : This study examines the psychosocial outcomes of women discharged from the Vlore Psychiatric Hospital in Albania . Methods : The study was design ed as a controlled , not r and omized , follow-up study . It included 16 women diagnosed with psychosis who were discharged from a psychiatric hospital to live in group homes in the community . The control group included 20 women diagnosed with psychosis who lived at the psychiatric hospital while awaiting discharge . All subjects were assessed twice using the HoNOS-Rome tool , at the start of the study ( T0 ) and 12 months later ( T1 ) . Results : Both groups showed an improvement in the HoNOS total score between T0 and T1 ( p < .001 ) . This improvement was significantly larger in the Home group compared to the Hospital group ( p = .014 ) . An item-level analysis indicated a significantly greater improvement in the Home group on items 11 ( autonomy ) , 12 ( work ) , 16 ( family ) and 18 ( goals ) . Conclusions : Projects for social inclusion of people suffering from psychosis must design living spaces that offer viable alternatives to psychiatric hospitals . This study also documents the efforts in the Vlore region of Albania to follow European st and ards of mental health care
Output:
| Our results contradict the findings of ecological studies which indicated a strong correlation between the decreasing number of psychiatric beds and an increasing number of people with mental health problems who were homeless or in prison |
MS212917 | ***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: Summary Prognostic models that predict the clinical course of a breast cancer patient are important in oncology . We propose an approach to constructing such models based on fractional polynomials in which useful transformations of the continuous factors are determined . The idea may be applied with all types of regression model , including Cox regression , the method of choice for survival-time data . We analyse a prospect i ve study of node-positive breast cancer . Seven st and ard prognostic factors – age , menopausal status , tumour size , tumour grade , number of positive lymph nodes , progesterone and oestrogen receptor concentrations – were investigated in 686 patients , of whom 299 had an event for recurrence-free survival and 171 died . We determine a final model with transformations of prognostic factors and compare it with the more traditional approaches using categorized variables or assuming a straight line relationship . We conclude that analysis using fractional polynomials can extract important prognostic information which the traditional approaches may miss
Output:
| General availability of full individual patient data is a necessary step forward and would overcome the majority of problems encountered , including poorly reported summary statistics and variability in cutoff level , outcome assessed and adjustment factors used . |
MS212918 | ***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: Severe postoperative pain , which may persist for up to 3 days and may lead to postoperative complications , due to the patient 's inability to breathe deeply and cough , is frequently experienced in the area of the incision and chest tubes by thoracotomy patients . Eighteen patients undergoing routine thoracotomies were tested preoperatively for arterial blood gases and pulmonary function and given chest x – rays . Anesthesia consisted of thiopental , succinylcholine , N2O , enflurane , and pancuronium . Before incision closure , 6 intercostal spaces were injected by the surgeon with 3 ml of a r and omly determined drug mixture . Patients received either bupivacaine and saline solution , bupivacaine and LMW dextran 40 , or saline and LMW dextran 40 . Arterial blood gases , pulmonary function , chest x-rays , narcotic dosage , sensory level , and subjective responses were evaluated for 3 days postoperatively . Results demonstrate that intercostal nerve blocks can markedly reduce postoperative pain and improve pulmonary function in such patients . Significant differences from controls were seen in Paoz , Paces , vital capacity , forced expiratory flow rates , analgesic requirements , and patient comfort . The duration of the block with bupivacaine and saline was less than 12 hours , while the mean duration of the block with bupivacaine and dextran 40 was 36 hours Twenty patients scheduled for lateral thoracotomy were r and omly allocated to receive either epidural morphine at regular intervals or subcutaneous nicomorphine on dem and for postoperative pain relief . The daily dose of opiate administered was greater in the group receiving subcutaneous nicomorphine than in the epidural group although four patients in the latter needed additional subcutaneous injections of opiate . During the first three days of the postoperative course , a profound decrease of the forced vital capacity ( FVC ) , the forced expiratory volume in one second ( FEV1 ) , peak expiratory flow rate ( PEF ) and the arterial oxygen tension ( PaO2 ) was found in both groups , whereas the visual analogue pain score showed a marked increase , and the arterial pH and carbon dioxide tension ( PaCO2 ) remained unchanged . No significant difference could be demonstrated between the group;s . The conclusion is that epidural morphine may produce sufficient pain relief after thoracotomy , but compared with conventional pain treatment the benefits are limited Administration of large doses of fentanyl is a popular method to provide postoperative analgesia after thoracotomy . It is however unclear whether epidural lumbar ( L ) or epidural thoracic ( T ) administration of fentanyl confers any major advantage over intravenous ( iv ) infusion . Using a r and omized prospect i ve study design , we compared the potential benefits of L , T , and iv fentanyl administration after thoracotomy in 50 patients . Epidural catheters were not injected during surgery . Postoperatively a fentanyl infusion ( 5 micrograms/ml ) was started at 1 microgram.kg-1.h-1 after a bolus of 1 microgram/kg and adjusted to maintain a score < or = 30/100 at rest using a visual analog scale ( VAS ) for pain . Data were prospect ively collected before surgery , at fixed intervals during the 48 h of fentanyl infusions , and the day of discharge . There was no difference between the groups in overall quality of analgesia at rest and after coughing , quantity of fentanyl delivered ( L = 1.15 + /- 0.38 , T = 1.22 + /- 0.23 , iv = 1.27 + /- 0.3 micrograms.kg-1.h-1 ) , incidence of pruritus needing treatment ( L = 2 , T = 1 , iv = 0 patients ) , need to decrease fentanyl infusion rate because of side effects ( L = 2 , T = 2 , iv = 4 patients ) , importance of pulmonary infiltrates , or arterial blood gas values . One patient ( L group ) needed naloxone ( 0.04 mg iv ) . Intravenous patients were more frequently nauseated ( P = .009 ) and needed boluses of fentanyl more often ( L = 3 + /- 9 , iv = 6 + /- 12 , T = 4 + /- 8 ; P = .04 ) . ( ABSTRACT TRUNCATED AT 250 WORDS In this clinical , r and omized , prospect i ve study , we compared the effects of three different analgesia techniques ( thoracic epidural analgesia [ TEA ] with and without preoperative initiation and IV patient-controlled analgesia [ IV-PCA ] ) on postthoracotomy pain in 69 patients . In two groups , a thoracic epidural catheter was inserted preoperatively . Group Pre-TEA had bupivacaine and morphine solution preoperatively and intraoperatively . Postoperative analgesia was maintained with epidural PCA with a similar solution . Group Post-TEA , with no intraoperative medication , had the same postoperative analgesia as Group Pre-TEA plus the bolus dose . Group IV-PCA received only IV-PCA with morphine for postoperative analgesia . Pain was evaluated every 4 h during the first 48 h at rest , cough , and movement . Pre-TEA was associated with decreased pain compared with the other groups . Six months later , the patients were asked about their pain . The incidence and the intensity of pain were most frequent in Group IV-PCA ( 78 % ) and were the least in Group Pre-TEA ( 45 % ) ( Group Pre-TEA versus Group IV-PCA , P = 0.0233 ; Group Pre-TEA versus Group IV-PCA , P = 0.014 ) . Patients having pain on the second postoperative day had 83 % chronic pain . TEA with preoperative initiation is a preferable method in preventing acute and long-term thoracotomy pain Four different pain treatments ( single intercostal block with bupivacaine , repeated intercostal block , epidural morphine and epidural bupivacaine infusions ) were compared in 39 patients subjected to lung surgery under general anaesthesia . The patients ' own estimate of the postoperative pain was not significantly different between the groups , but the epidurally treated patients required fewer doses of supplementary analgesic than those given just a single dose of intercostal bupivacaine . Bupivacaine levels in blood were below the toxic range in all groups . The concentration of antidiuretic hormone in blood was increased early during the operation , and had only partly returned to normal on the first postoperative morning . Growth hormone in plasma was increased only at the end of the operation . Catecholamine levels in blood increased gradually , reaching their peak postoperatively . There were only slight differences between the groups in these posterior and anterior pituitary and sympatho‐adrenal responses to surgical stress . Thus , neither repeated intercostal blockade nor epidural administration of morphine or bupivacaine could prevent the endocrine responses to thoracic surgery , in spite of significant , albeit incomplete , pain relief . This was probably caused in part by residual pain , and also by poor access of the extradural medications to the autonomic afferent pathways mediating nociceptive signals from thoracic organs and tissues This study was undertaken to evaluate the effectiveness of 0.5 % bupivacaine ( 360 mg/day ) as a continuous infusion through an indwelling intercostal catheter inserted intraoperatively in the management of pain after thoracotomy . Eighty-six patients were r and omized into three groups : group 1 = intercostal bupivacaine , group 2 = intercostal saline solution , and group 3 = fixed-schedule intramuscular buprenorphine . Supplementary buprenorphine was given as required . Pain and pulmonary function were assessed throughout the first 5 days after operation . Pain score was lower in group 1 than in group 2 for the first 8 hours after operation ( p < 0.02 ) . During the first 3 postoperative days , mean postoperative pain scores of 5 or more were recorded in 9 % of group 1 patients versus 40 % of group 2 patients ( p < 0.05 ) and 13 % of group 3 patients ( not significant ) . Total doses of buprenorphine were lower in groups 1 and 2 than in group 3 ( p < 0.001 ) . No between-group differences in pulmonary function were observed . Respiratory complications occurred in no patients in groups 1 and 3 versus 5 in group 2 ( p < 0.05 ) . Continuous intercostal bupivacaine provided similar early pain control as compared with fixed-schedule narcotics but induced better analgesia with fewer complications than on-dem and narcotics alone ( group 2 ) The purpose of this study was to compare meperidine to meperidine with bupivacaine when used for patient-controlled epidural analgesia ( PCEA ) after thoracotomy . For 3 days after thoracotomy patients received thoracic PCEA with meperidine 0.1 % plain or with added bupivacaine 0.1 % or 0.01 % . No background infusion was used . All patients received indomethacin postoperatively for the duration of the study . Patients were assessed with respect to meperidine consumption , analgesia , and side effects . Sixty-six patients participated . Patients in all three groups obtained effective analgesia with median meperidine consumption of 5 - 6 mg/h . There were no significant differences between groups in meperidine consumption or pain scores at rest or with coughing . The addition of bupivacaine 0.1 % reduced the incidence of pruritus ( P = 0.036 ) , but 5 of 23 patients in this group were withdrawn from the study because of significant hypotension , oliguria , and /or motor or sensory block ( P = 0.006 ) . We conclude that the addition of bupivacaine 0.1 % or 0.01 % to thoracic PCEA meperidine 0.1 % does not affect meperidine requirements or analgesia after thoracotomy . The addition of bupivacaine 0.1 % may reduce pruritus , but is associated with signs of excessive sensory , motor , or autonomic blockade in a significant number of patients . ( Anesth Analg 1996;83:81 - 6 OBJECTIVE Long-term pain is a common sequela of thoracotomy , occurring in approximately 50 % of patients 2 years after thoracic surgery . Despite this alarming statistic , little is known about the factors responsible for the transition of acute to chronic pain . The aim of the present study is to identify predictors of long-term post-thoracotomy pain . DESIGN Follow-up was for 1.5 years for patients who had participated in a prospect i ve , r and omized , controlled trial of preemptive , multimodal analgesia . SETTING Subjects were recruited from a tertiary care center . PATIENTS Thirty patients who had undergone lateral thoracotomy were followed up by telephone , administered a structured interview , and classified according to long-term pain status . MAIN OUTCOME MEASURES Present pain status was measured by a verbal rating scale ( VAS ) . Measures obtained within the first 48 h after surgery were compared between patients with and without pain 1.5 years later . These include VAS pain scores at rest and after movement , McGill Pain Question naire data , patient-controlled morphine consumption ( mg ) , and pain thresholds to pressure applied to a rib contralateral to the thoracotomy incision . RESULTS Fifty-two percent of patients reported long-term pain . Early postoperative pain was the only factor that significantly predicted long-term pain . Pain intensity 24 h after surgery , at rest , and after movement was significantly greater among patients who developed long-term pain compared with pain-free patients . A significant predictive relationship was also found at 24 and 48 h using the McGill Pain Question naire . Cumulative morphine was comparable for the two groups . Pain thresholds to pressure applied to a rib contralateral to the incision did not differ significantly between the groups . CONCLUSION Aggressive management of early postoperative pain may reduce the likelihood of long-term post-thoracotomy pain Twenty‐five ASA 1 or 2 patients undergoing thoracotomy were entered into a prospect i ve , r and omised , double‐blind study comparing thoracic epidural fentanyl alone and thoracic epidural fentanyl combined with 0.2 % bupivacaine . Pain relief , pulmonary function and cardiovascular stability were assessed . Pain relief was superior in the bupivacaine series ( p < 0.05 ) during the first day after operation and this was accompanied by better oxygenation ( p < 0.05 ) ; the difference did not persist into the second day . Forced expiratory variables were reduced in both series to 50–60 % of the values before operation throughout the study ( p < 0.05 ) and differences did not occur between the groups . The incidence of side effects attributable to epidural fentanyl was high , but hypotension did not occur . Small doses of bupivacaine administered together with fentanyl into the thoracic epidural space improve analgesia without causing hypotension The effects of diamorphine hydrochloride 0.1 mg/kg , given either extradurally or intramuscularly for postoperative analgesia were compared in two r and omised double‐blind studies involving 39 patients undergoing thoracotomy and major gynaecological surgery . Assessment s were made at fixed intervals after the administration of diamorphine and consisted of the measurement of pain or analgesic effect . Segmental , sympathetic and any adverse effects were sought . There was no significant difference in the quality of analgesia between the two groups in either trial . Ext
Output:
| RESULTS : Continuous paravertebral block was as effective as thoracic epidural analgesia with local anesthetic ( LA ) but was associated with a reduced incidence of hypotension .
Paravertebral block reduced the incidence of pulmonary complications compared with systemic analgesia , whereas thoracic epidural analgesia did not .
Thoracic epidural analgesia was superior to intrathecal and intercostal techniques , although these were superior to systemic analgesia ; interpleural analgesia was inadequate .
: Either thoracic epidural analgesia with LA plus opioid or continuous paravertebral block with LA can be recommended . |
MS212919 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background and Purpose Although surgery has been widely accepted as the treatment of choice for stress urinary incontinence ( SUI ) , there has recently been an increased interest in the conservative management of this condition . The aims of this study were to test the ability of a biofeedback-assisted pelvic-floor muscle exercise ( PFME ) program to affect symptoms of SUI in premenopausal women and to evaluate a training program that might lead to successful outcomes in a relatively limited number of sessions . Subjects Twenty-six women with SUI were treated with PFME with surface electromyography (sEMG)–assisted biofeedback . All participants were of reproductive age and were treated individually for 12 sessions . Methods Results were evaluated with a 7-day voiding diary , a 1-hour pad test , pelvic-floor muscle strength measurements , sEMG amplitudes , a leakage index , and a quality -of-life question naire . These variables were compared before and after the intervention . Results The frequency of urine loss , the occurrence of nocturia , and the number of pads required decreased significantly after the intervention . Objective cure was found in 61.5 % of women . There was a significant improvement in the quality of life , in pelvic-floor muscle strength , and in the sEMG amplitudes of all contractions throughout the intervention . Discussion and Conclusion A relatively short-term intervention of PFME with sEMG-assisted biofeedback appeared to be helpful in relieving symptoms of SUI in premenopausal women and represents a reasonable conservative management option PURPOSE To compare the effectiveness of pelvic floor exercises , electrical stimulation , vaginal cones , and no active treatment in women with urodynamic stress urinary incontinence . PATIENTS AND METHODS One hundred eighteen subjects were r and omly selected to recieve pelvic floor exercises ( n=31 ) , ES ( n=30 ) , vaginal cones ( n=27 ) , or no treatment ( untreated control ) ( n=30 ) . Women were evaluated before and after completion of six months of treatment by the pad test , quality of life question naire ( I-QOL ) , urodynamic test , voiding diary , and subjective response . RESULTS In the objective evaluation , we observed a statistically significant reduction in the pad test ( p=0.003 ) , in the number of stress urinary episodes ( p<0.001 ) , and a significant improvement in the quality of life ( p<0.001 ) in subjects who used pelvic floor exercises , electrical stimulation , and vaginal cones compared to the control group . No significant difference was found between groups in the urodynamic parameters . In the subjective evaluation , 58 % , 55 % , and 54 % of women who had used pelvic floor exercises , electrical stimulation , and vaginal cones , respectively , reported being satisfied after treatment . In the control group , only 21 % patients were satisfied with the treatment . CONCLUSION Based on this study , pelvic floor exercises , electrical stimulation , and vaginal cones are equally effective treatments and are far superior to no treatment in women with urodynamic stress urinary incontinence Background Stress urinary incontinence ( SUI ) is a prevalent and costly condition which may be treated surgically or by physical therapy . The aim of this review was to systematic ally assess the literature and present the best available evidence for the efficacy and effectiveness of pelvic floor muscle training ( PFMT ) performed alone and together with adjunctive therapies ( eg biofeedback , electrical stimulation , vaginal cones ) for the treatment of female SUI . Methods All major electronic sources of relevant information were systematic ally search ed to identify peer- review ed English language abstract s or papers published between 1995 and 2005 . R and omised controlled trials ( RCTs ) and other study design s eg non-r and omised trials , cohort studies , case series , were considered for this review in order to source all the available evidence relevant to clinical practice . Studies of adult women with a urodynamic or clinical diagnosis of SUI were eligible for inclusion . Excluded were studies of women who were pregnant , immediately post-partum or with a diagnosis of mixed or urge incontinence . Studies with a PFMT protocol alone and in combination with adjunctive physical therapies were considered . Two independent review ers assessed the eligibility of each study , its level of evidence and the method ological quality . Due to the heterogeneity of study design s , the results are presented in narrative format . Results Twenty four studies , including 17 RCTs and seven non- RCTs , met the inclusion criteria . The method ological quality of the studies varied but lower quality scores did not necessarily indicate studies from lower levels of evidence . This review found consistent evidence from a number of high quality RCTs that PFMT alone and in combination with adjunctive therapies is effective treatment for women with SUI with rates of ' cure ' and ' cure/improvement ' up to 73 % and 97 % respectively . The contribution of adjunctive therapies is unclear and there is limited evidence about treatment outcomes in primary care setting s. Conclusion There is strong evidence for the efficacy of physical therapy for the treatment for SUI in women but further high quality studies are needed to evaluate the optimal treatment programs and training protocol s in subgroups of women and their effectiveness in clinical practice Biofeedback is a method of pelvic floor rehabilitation using a surface electrode inserted into the vagina and a catheter in the rectum . Forty women with genuine urinary stress incontinence were r and omized to compare the efficacy of physiotherapy and physiotherapy in combination with biofeedback . The effect of the treatment was determined by a st and ardized pad-weighing test . Long-term status was determined using a question naire after 2–3 years . Thirty-four women completed the treatment . The study showed a statistically significant better improvement in the biofeedback group . The long-term effect in the biofeedback group seemed better and the patients were more motivated for training afterwards Abstract Objective : To compare the effect of pelvic floor exercises , electrical stimulation , vaginal cones , and no treatment for genuine stress incontinence . Design : Stratified , single blind , r and omised controlled trial . Setting : Multicentre . Participants : 107 women with clinical ly and urodynamically proved genuine stress incontinence . Mean ( range ) age was 49.5 ( 24 - 70 ) years , and mean ( range ) duration of symptoms 10.8 ( 1 - 45 ) years . Interventions : Pelvic floor exercise ( n=25 ) comprised 8 - 12 contractions 3 times a day and exercise in groups with skilled physical therapists once a week . The electrical stimulation group ( n=25 ) used vaginal intermittent stimulation with the MS 106 Twin at 50 Hz 30 minutes a day . The vaginal cones group ( n=27 ) used cones for 20 minutes a day . The untreated control group ( n=30 ) was offered the use of a continence guard . Muscle strength was measured by vaginal squeeze pressure once a month . Main outcome measures : Pad test with st and ardised bladder volume , and self report of severity . Results : Improvement in muscle strength was significantly greater ( P=0.03 ) after pelvic floor exercises ( 11.0 cm H2O ( 95 % confidence interval 7.7 to 14.3 ) before v 19.2 cm H2O ( 15.3 to 23.1 ) after ) than either electrical stimulation ( 14.8 cm H2O ( 10.9 to 18.7 ) v 18.6 cm H2O ( 13.3 to 23.9 ) ) or vaginal cones ( 11.8 cm H2O ( 8.5 to 15.1 ) v 15.4 cm H2O ( 11.1 to 19.7 ) ) . Reduction in leakage on pad test was greater in the exercise group ( −30.2 g ; −43.3 to 16.9 ) than in the electrical stimulation group ( −7.4 g ; −20.9 to 6.1 ) and the vaginal cones group ( −14.7 g ; −27.6 to −1.8 ) . On completion of the trial one participant in the control group , 14 in the pelvic floor exercise group , three in the electrical stimulation group , and two in the vaginal cones group no longer considered themselves as having a problem . Conclusion : Training of the pelvic floor muscles is superior to electrical stimulation and vaginal cones in the treatment of genuine stress incontinence OBJECTIVE : The aim of this study was to compare the effectiveness of multimodal supervised physiotherapy programs with the absence of treatment among women with persistent postnatal stress urinary incontinence . METHODS : This was a single-blind r and omized controlled trial . Sixty-four women with stress urinary incontinence were r and omly assigned to 8 weeks of either multimodal pelvic floor rehabilitation ( n = 21 ) , multimodal pelvic floor rehabilitation with abdominal muscle training ( n = 23 ) , or control non – pelvic floor rehabilitation ( n = 20 ) . The primary outcome measure consisted of a modified 20-minute pad test . The secondary outcome measures included a Visual Analog Scale describing the perceived burden of incontinence , the Urogenital Distress Inventory , the Incontinence Impact Question naire , and pelvic floor muscle function measurements . RESULTS : Two patients dropped out , leaving 62 for analysis . At follow-up , more than 70 % of the women in the treatment groups ( 14/20 in the pelvic floor and 17/23 in the pelvic floor plus abdominal group ) were continent on pad testing compared with 0 % of women in the control group . Scores on the pad test , Visual Analog Scale , Urogenital Distress Inventory , and Incontinence Impact Question naire improved significantly in both treatment groups ( all P < .002 ) , whereas no changes were observed in the control group . Pelvic floor muscle function , however , did not improve significantly in either active group . CONCLUSION : Multimodal supervised pelvic floor physiotherapy is an effective treatment for persistent postnatal stress urinary incontinence . LEVEL OF EVIDENCE : Purpose : The aim of this study was to investigate and compare the short-term effects of a physical therapy program in patients with different intensities of urodynamic stress urinary incontinence ( USI ) . Subjects and Methods : 48 patients with USI were assigned to three groups according to the intensity of their incontinence : group I : 0–2 g ( n = 17 ) , group II ( mild intensity : > 2–10 g , n = 16 ) and group III ( moderate intensity : > 10 g , n = 15 ) as determined by the 1-hour pad test . A physical therapy program composed of Kegel exercises and interferential current was applied to all patients for duration of 5 weeks , with a total of 15 sessions . The number of pads used a day , frequency of voiding ( times/day ) , amount of urinary leakage according to the 1-hour pad test ( mg ) , severity of complaint ( as centimeters on visual analogue scale ) and pelvic floor muscle strength ( cm Hg ) were evaluated . Pre-treatment and post-treatment values of these data were compared in each group and among groups . Results : Analyses of the data indicated that the number of pads used a day , frequency of voiding and amount of urinary leakage decreased and pelvic floor muscle strength increased significantly in each group ( p < 0.05 ) . Cure in USI was found in 88 % of subjects in group I and 18 % of subjects in group II ( mild intensity ) . None of the patients in group III ( moderate intensity ) showed a cure effect . Conclusion : This physical therapy program was found to be more effective in mild and moderate intensities than severe USI Introduction and hypothesisPelvic floor muscle training ( PFMT ) is considered to be the first-line treatment for female stress urinary incontinence ( SUI ) . There are few studies that have tested the efficacy of unsupervised PFMT . The aim of this study was to compare the effectiveness of intensive supervised PFMT to unsupervised PFMT in the treatment of female SUI . Methods Sixty-two women with SUI were r and omized to either supervised or unsupervised PFMT after undergoing supervised training sessions . They were evaluated before and after the treatment with the Oxford grading system , pad test , quality of life question naire , subjective evaluation , and exercise compliance . Results After treatment , there were no differences between the two groups regarding PFM strength ( p = 0.20 ) , International Consultation on Incontinence Question naire-Short Form score ( p = 0.76 ) , pad test ( p = 0.78 ) , weekly exercise compliance ( p = 0.079 ) , and subjective evaluation of urinary loss ( p = 0.145 ) . Conclusions Both intensive supervised PFMT and unsupervised PFMT are effective to treat female SUI if training session is provided CONTEXT AND OBJECTIVE Urinary incontinence is a public health problem that affects more than 200 million people worldwide . Stress incontinence is the most prevalent type . Pelvic floor muscle exercises have been used for treating it , although there is no consensus regarding their application . The aim of this study was to compare the results from treating female stress urinary incontinence with pelvic floor muscle exercises with or without physiotherapist supervision . DESIGN AND SETTING This was a r and omized , prospect i ve , controlled trial in the Urogynecology and Vaginal Surgery Sector , Universidade Federal de São Paulo . METHODS Forty-four women were r and omized to be treated for stress urinary incontinence with pelvic floor exercises for three consecutive months , into two groups : one with and the other without physiotherapist supervision . They were evaluated before and after treatment using a quality -of-life question naire , pad test , micturition diary and subjective evaluation . Descriptive analysis was used
Output:
| The most effective training protocol consists of SEPFM by digital palpation combined with biofeedback monitoring and vaginal cones , including 12 week training parameters , and ten repetitions per series in different positions compared with SEPFM alone or a lack of treatment |
MS212920 | ***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 Shock-absorbing and biomechanic shoe orthoses are frequently used in the prevention and treatment of back and lower extremity problems . One review concludes that the former is clinical ly effective in relation to prevention , whereas the latter has been tested in only 1 r and omized clinical trial , concluding that stress fractures could be prevented . OBJECTIVES To investigate if biomechanic shoe orthoses can prevent problems in the back and lower extremities and if reducing the number of days off-duty because of back or lower extremity problems is possible . DESIGN Prospect i ve , r and omized , controlled intervention trial . STUDY SUBJECTS One female and 145 male military conscripts ( aged 18 to 24 years ) , representing 25 % of all new conscripts in a Danish regiment . METHOD Health data were collected by question naires at initiation of the study and 3 months later . Custom-made biomechanic shoe orthoses to be worn in military boots were provided to all in the study group during the 3-month intervention period . No intervention was provided for the control group . Differences between the 2 groups were tested with the chi-square test , and statistical significance was accepted at P < .05 . Risk ratio ( RR ) , risk difference ( ARR ) , numbers needed to prevent ( NNP ) , and cost per successfully prevented case were calculated . OUTCOME VARIABLES Outcome variables included self-reported back and /or lower extremity problems ; specific problems in the back or knees or shin splints , Achilles tendonitis , sprained ankle , or other problems in the lower extremity ; number of subjects with at least 1 day off-duty because of back or lower extremity problems and total number of days off-duty within the first 3 months of military service because of back or lower extremity problems . RESULTS Results were significantly better in an actual-use analysis in the intervention group for total number of subjects with back or lower extremity problems ( RR 0.7 , ARR 19 % , NNP 5 , cost 98 US dollars ) ; number of subjects with shin splints ( RR 0.2 , ARR 19 % , NNP 5 , cost 101 US dollars ) ; number of off-duty days because of back or lower extremity problems ( RR 0.6 , ARR < 1 % , NNP 200 , cost 3750 US dollars ) . In an intention-to-treat analysis , a significant difference was found for only number of subjects with shin splints ( RR 0.3 , ARR 18 % , NNP 6 cost 105 US dollars ) , whereas a worst-case analysis revealed no significant differences between the study groups . CONCLUSIONS This study shows that it may be possible to prevent certain musculoskeletal problems in the back or lower extremities among military conscripts by using custom-made biomechanic shoe orthoses . However , because care-seeking for lower extremity problems is rare , using this method of prevention in military conscripts would be too costly . We also noted that the choice of statistical approach determined the outcome Study Design . R and omized controlled trial . Objectives . To determine if the use of custom shoe orthoses can lessen the incidence of weight bearing-induced back pain . Summary of Background Data . The scientific basis for the use of orthoses to prevent back pain is based principally on studies that show that shoe orthoses can attenuate the shock wave generated at heel strike . The repetitive impulsive loading that occurs because of this shock wave can cause wear of the mechanical structures of the back . Previous r and omized studies showed mixed results in preventing back pain , were not blinded , and used orthoses for only short periods of time . Methods . A total of 404 eligible new infantry recruits without a history of prior back pain were r and omly assigned to received either custom soft , semirigid biomechanical , or simple shoe inserts without supportive or shock absorbing qualities . Recruits were review ed biweekly by an orthopaedist for back signs and symptoms during the course of 14 weeks of basic training Results . The overall incidence of back pain was 14 % . By intention-to treat and per- protocol analyses , there was no statistically significant difference between the incidence of either subjective or objective back pain among the 3 treatment groups . Significantly more recruits who received soft custom orthoses finished training in their assigned orthoses ( 67.5 % ) than those who received semirigid biomechanical orthoses ( 45.5 % ) or simple shoe inserts ( 48.6 % ) , P = 0.001 . Conclusions . The results of this study do not support the use of orthoses , either custom soft or semirigid biomechanical , as prophylactic treatment for weight bearing-induced back pain . Custom soft orthoses had a higher utilization rate than the semirigid biomechanical or simple shoe inserts . The pretraining physical fitness and sports participation of recruits were not related to the incidence of weight bearing-induced back pain & NA ; Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies The prevalence and incidence of low back pain in general society is high . Workers whose job involves walking long distances have an even higher tendency to suffer from low back pain . A positive effect of insoles in reducing low back pain was found in professional sports players . This was not examined on people whose job involves walking long distances . In this double blind prospect i ve study we examined the effectiveness of insoles constructed in a computerized method to placebo insoles in 58 employees whose work entailed extensive walking and who suffered from low back pain . The evaluation was performed by the MILLION question naire , which is considered as a valid question naire for evaluation of low back pain . We calculated the differences of the pain intensity before and after the intervention , in the employees using the insoles manufactured by computer in comparison to the users of the placebo insoles . In each group , the analysis was performed in comparison to the baseline . A total of 81 % of the employees preferred the real insoles as effective and comfortable in comparison to 19 % of the users of the placebo insoles ( P<0.05 ) . The results of this study indicate a substantial improvement in the low back pain after the use of the true insoles . The average pain intensity according to the MILLION question naire before the use of the insoles was 5.46 . However , after the use of the real insoles and the placebo insoles , the average pain intensity decreased to 3.96 and 5.11 , respectively . The difference of the average pain intensity at the start of the study and after the use of the real insoles was significant : −1.49 ( P=0.0001 ) , whereas this difference after the use of the placebo insoles was not significant : −0.31 ( P=0.1189 ) . The reported severity of pain also decreased significantly : a level 5 pain and above was reported by 77 % of the subjects at the start of the study . After the use of the real insoles only 37.9 % of the subjects reported a similar degree of pain severity , and 50 % of the subjects did so after the use of the placebo insoles ( P < 0.05 ) . We did not find a link between low back pain and other variables such as gender , age , number of offspring , work seniority , smoking , previous use of insoles and previous medication . This study demonstrates that the low back pain decreased significantly after the use of real insoles compared to placebo ones Sedentary individuals , particularly new military recruits , who start a physical training program have a substantial risk of developing an overuse injury of the lower limb . In this study we investigated the effect of neoprene insoles on the incidence of overuse injuries during 9 weeks of basic military training . The experimental group consisted of 237 r and omly selected new recruits , while 1151 recruits were the control group . Insoles were given to the experimental group and compliance was monitored . A panel of doctors documented and classi fied all injuries occurring during the 9 week period . A total of 54 ( 22.8 % ) and 237 ( 31.9 % ) injuries were reported in the experimental and control groups , re spectively . In both groups , the majority of injuries were overuse ( experimental group , 90.7 % ; control group , 86.4 % ) . The mean weekly incidence of total overuse injuries and tibial stress syndrome was significantly lower ( P < 0.05 ) in the experimental group . The mean incidence of stress fractures was lower in the experimental group but not significantly so ( 0.05 < P < 0.1 ) . This study shows that the incidence of total overuse injuries and tibial stress syndrome during 9 weeks of basic military training can be reduced by wearing insoles A new approach to treating chronic low-back pain with custom-made foot orthoses was investigated . The Quebec Back Pain Disability Scale was used to objective ly assess the functional disability of 32 subjects at different times . Subjects in this prospect i ve study experienced more than twice the improvement in alleviation of pain , and for twice as long , compared with subjects in a study using traditional back-pain treatment . The authors believe that the findings of this study may provide a new method by which patients with chronic low-back pain can be evaluated and treated The purpose of this study was to assess the effect of viscoelastic shoe inserts on pain in nursing students . Students ( N = 100 ) were r and omly assigned to control and viscoelastic groups . The viscoelastic group used viscoelastic insoles in their work shoes for five weeks . A pain question naire was used to measure location and intensity of post-work pain . The question naire was administered as a pre-test and after five weeks . Post-test comparisons between groups indicated significant differences which were not present at pre-test . The viscoelastic group reported a significant peripheral shift in pain location from back to lower extremity ; the viscoelastic group also showed significant changes in duration of post-work pain and frequency of pain during the workday . The clinical efficacy of viscoelastic shoe inserts for modifying weight bearing-induced back pain is supported . Further clinical research into the therapeutic and prophylactic value of shock-attenuating shoe inserts for healthy as well as patient population s is advocated
Output:
| There is strong evidence that the use of insoles does not prevent back pain .
There is limited evidence that insoles alleviate back pain or adversely shift the pain to the lower extremities .
There is strong evidence that insoles are not effective for the prevention of back pain . |
MS212921 | ***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 Catheter-restricted antibiotic lock solutions were found to be effective in the prevention of catheter-related bacteremia ( CRB ) , but insufficient data are available about the ideal agent and dose . We hypothesized that a low concentration of gentamicin would be as effective as the high doses studied in the past . METHODS In this prospect i ve , open-labeled , r and omized , clinical trial of patients on long-term hemodialysis therapy , patients were r and omly assigned to administration of an antibiotic lock solution of gentamicin/citrate ( 4 mg/mL ) , minocycline/EDTA , or the control solution of heparin . Patients were followed up until the study end point of CRB was reached or a censoring event occurred . Interim data analysis was performed after 6 months to assess data safety ; efficacy was noted and the study was terminated early . RESULTS Sixty-two patients were enrolled into the study , evenly distributed in 3 arms , with data from 1 patient excluded from analysis . Seven of 20 patients in the heparin group ( 4.0 events/1,000 catheter days ) , 1 of 21 patients in the minocycline group ( 0.4 events/1,000 catheter days ) , and none of 20 patients in the gentamicin group developed bacteremia . Results were statistically significant by using 2-tailed Fisher exact test ; heparin versus gentamicin , P = 0.008 , and heparin versus minocycline , P = 0.020 . CONCLUSION Antibiotic lock solutions are superior to the st and ard heparin lock alone in the prevention of CRBs , and low-dose gentamicin solution has efficacy similar to that of greater concentrations used in previous studies BACKGROUND The role and dose of anticoagulants in thromboprophylaxis for patients with cancer receiving chemotherapy through central venous catheters ( CVCs ) is controversial . We therefore assessed whether warfarin reduces catheter-related thrombosis compared with no warfarin and whether the dose of warfarin determines the thromboprophylactic effect . METHODS In 68 clinical centres in the UK , we r and omly assigned 1590 patients aged at least 16 years with cancer who were receiving chemotherapy through CVCs to no warfarin , fixed-dose warfarin 1 mg per day , or dose-adjusted warfarin per day to maintain an international normalised ratio between 1.5 and 2.0 . Clinicians who were certain of the benefit of warfarin r and omly assigned patients to fixed-dose or dose-adjusted warfarin groups . The primary outcome was the rate of radiologically proven , symptomatic catheter-related thrombosis . Analysis was by intention to treat . This trial is registered as an International St and ard R and omised Controlled Trial , number IS RCT N 50312145 . FINDINGS Compared with no warfarin ( n=404 ) , warfarin ( n=408 ; 324 [ 79 % ] on fixed-dose and 84 [ 21 % ] on dose-adjusted ) did not reduce the rate of catheter-related thromboses ( 24 [ 6 % ] vs 24 [ 6 % ] ; relative risk 0.99 , 95 % CI 0.57 - 1.72 , p=0.98 ) . However , compared with fixed-dose warfarin ( n=471 ) , dose-adjusted warfarin ( n=473 ) was superior in the prevention of catheter-related thromboses ( 13 [ 3 % ] vs 34 [ 7 % ] ; 0.38 , 0.20 - 0.71 , p=0.002 ) . Major bleeding events were rare ; an excess was noted with warfarin compared with no warfarin ( 7 vs 1 , p=0.07 ) and with dose-adjusted warfarin compared with fixed-dose warfarin ( 16 vs 7 , p=0.09 ) . A combined endpoint of thromboses and major bleeding showed no difference between comparisons . We did not note a survival benefit in either comparison . INTERPRETATION The findings show that prophylactic warfarin compared with no warfarin is not associated with a reduction in symptomatic catheter-related or other thromboses in patients with cancer and therefore we should consider newer treatments . FUNDING Medical Research Council and Cancer Research UK PURPOSE The purpose of this study was to analyze the effectiveness of saline solution vs. heparinized-saline for maintenance of arterial lines and to detect changes in platelet and aPTT as physiological indexes . METHODS In this nonequivalent control group , non-synchronized , double-blind study the effects of heparinized and saline solution on the maintenance of arterial lines were compared . Fifty five patients received the heparinized solution and fifty nine patients received the saline solution . All patients who had surgery in K-university hospital between September and December 2011 were eligible for participation in the study . RESULTS There was no statistically significant difference between the saline and the heparin group in the maintenance time of the arterial lines or the number of irrigations . There was no statistically significant difference between the groups in changes in the number of platelets and aPTT for interaction between the groups and time intervals . CONCLUSION The results indicate that saline solution can be used as an irrigation solution for the maintenance of arterial lines of adult surgical patients , rather than heparinized-saline , in view of potential risk factors in the use of heparin INTRODUCTION AND AIMS The Subclavian vein has been traditionally the vein of choice for central venous catheterization by general surgeons . Alternative setting s for the introduction of totally implantable venous access devices ( TIVAD ) and the search for lower rates of morbidity led to the choice of other central veins . This study compares two different venous accesses , the subclavian ( SC ) versus the internal jugular ( IJ ) , in terms of early and late morbidity . PATIENTS AND METHODS This is a prospect i ve , non-r and omized , observational , uni-institutional ( tertiary cancer centre ) study . From March 2003 to March 2006 , 1231 TIVADs were placed ( 1201 patients ) , in an ambulatory operating room , under vital signs and EKG monitoring , using local anaesthesia and without perioperative radiological control . RESULTS Of the 1231 TIVAD , 617 were inserted via the SC and 614 via the IJ vein . The two groups ( SC vs. IJ ) were comparable as to general patient characteristics . Immediate complications were more frequent in the SC than in the IJ approach ( respectively , 5.0 % vs. 1.5 % ; p<0.001 ) ; Catheter malposition occurred in 2.3 % when using the SC vein and in 0.2 % for the IJ ( p=0.001 ) . Long term morbidity was also more frequent in the SC than in the IJ group ( respectively , 15.8 % , 87/551 , vs. 7.6 % , 39/512 ; p<0.001 ) . Venous thrombosis developed in 2.0 % of patients with an SC TIVAD as compared to 0.6 % with an IJ TIVAD ( p=0.044 ) . Catheter malfunction was significantly dependent on the vein used : SC - 9.4 % vs. IJ - 4.3 % ( p=0.001 ) . CONCLUSIONS Our results support the preferential use of the Internal Jugular vein for the insertion of TIVAD INTRODUCTION Catheter-related infection is associated with increased all-cause mortality and morbidity in hemodialysis patients . This study aim ed to evaluate an antimicrobial lock solution ( cloxacillin and heparin ) in temporary noncuffed double-lumen catheters for long-term intermittent hemodialysis as a method of preventing catheter-related infection . MATERIAL S AND METHODS Patients on hemodialysis with noncuffed temporary double lumen catheter were r and omly divided into 2 groups . Fifty patients received a solution containing cloxacillin , 100 mg/mL , plus heparin , 1000 IU/mL as a 2.5-mL solution instilled in each of catheter lumens after dialysis session . Another 50 patients received only heparin . They were allowed to dwell until the next session of dialysis . RESULTS One catheter-related bacteremia was observed in the antibiotic group whereas catheter-related bacteremia was observed in 8 of those who received heparin only . The rate of catheter-related bacteremia episodes were 0.5 per 1000 catheter-days in the antibiotic group versus 7.8 per 1000 catheter-days in the control group ( P = .02 ) . CONCLUSIONS In the present study , application of cloxacillin as antibiotic lock solution for dialysis catheters result ed in a considerable reduction in catheter-related bacteremia rate BACKGROUND Heparin is used as a flush solution for intravenous and intra-arterial lines , but has a number of drug interactions , as well as potentially serious side effects . METHODS We compared the function of arterial lines for both monitoring and blood sampling when flushed with either normal saline or saline containing heparin ( 1 unit/mL ) . Sixty-five patients were recruited at this mixed medical and surgical Level 2 intensive care unit . Patients were r and omised to receive either normal saline ( NS ) or heparinised saline ( HS ) ( 3 mL/hour as a continuous flush ) . Each patient 's nurse was asked to score the function of the line at the end of each nursing shift . RESULTS 35 patients were recruited in the NS group and 30 in the HS group . Mean study duration was 5.8 and 6.6 days for the NS and HS groups , respectively . The scores for the intravascular line for each patient were summed , and the percentage of the total possible score was calculated . Mean percentage scores were 83 % ( NS group ) and 82 % ( HS group ) . Comparison using the central limit theorem showed no difference between the groups at the 95 % confidence interval ( -6 % to 10 % ) . CONCLUSIONS Heparin as a continuous flush at 3 units/hour does not improve the function of arterial lines compared with a continuous normal-saline flush BACKGROUND AND OBJECTIVES Citrate 4 % has antithrombotic and antibacterial properties , which makes it a potentially superior alternative to heparin as an indwelling intraluminal locking agent . DESIGN , SETTING , PARTICIPANTS , AND MEASUREMENTS Sixty-one prevalent hemodialysis ( HD ) patients dialyzing with a tunneled cuffed HD catheter were r and omized in a pilot study to receive either heparin 5000 U/ml or citrate 4 % as a locking agent after HD . The primary outcomes were the development of catheter dysfunction ( defined as a blood pump speed < 250 ml/min or the use of tissue plasminogen activator ) and catheter-associated bacteremia . The secondary outcomes were the development of an exit-site infection or bleeding complications ( either local or systemic ) . RESULTS Citrate had comparable catheter dysfunction episodes to heparin ( 13/32 [ 41 % ] cases versus 12/29 [ 41 % ] cases , respectively ) . There were no differences in the development of catheter-associated bacteremia ( 2.2/1000 catheter days citrate versus 3.3/1000 catheter days heparin group ; P = 0.607 ) or exit-site infection ( 2.2/1000 catheter days for both groups ) . CONCLUSIONS The preliminary findings from our pilot study demonstrate that 4 % citrate is effective in maintaining catheter patency and does not appear to have any increased incidence of infections . Because citrate is significantly cheaper and has a more favorable side effect profile than heparin , it can be considered a potentially better locking agent in HD catheters Background Catheter-related bacteraemias ( CRBs ) contribute significantly to morbidity , mortality and health care costs in dialysis population s. Despite international guidelines recommending avoidance of catheters for haemodialysis access , hospital admissions for CRBs have doubled in the last decade . The primary aim of the study is to determine whether weekly instillation of 70 % ethanol prevents CRBs compared with st and ard heparin saline . Methods / design The study will follow a prospect i ve , open-label , r and omized controlled design . Inclusion criteria are adult patients with incident or prevalent tunneled intravenous dialysis catheters on three times weekly haemodialysis , with no current evidence of catheter infection and no personal , cultural or religious objection to ethanol use , who are on adequate contraception and are able to give informed consent . Patients will be r and omized 1:1 to receive 3 mL of intravenous- grade 70 % ethanol into each lumen of the catheter once a week and st and ard heparin locks for other dialysis days , or to receive heparin locks only . The primary outcome measure will be time to the first episode of CRB , which will be defined using st and ard objective criteria . Secondary outcomes will include adverse reactions , incidence of CRB caused by different pathogens , time to infection-related catheter removal , time to exit site infections and costs . Prospect i ve power calculations indicate that the study will have 80 % statistical power to detect a clinical ly significant increase in
Output:
| Given the very low quality of the evidence , we are uncertain whether intermittent locking with heparin results in fewer occlusions than intermittent locking with NS .
Low- quality evidence suggests that heparin may have little or no effect on catheter patency .
Although we found no evidence of differences in safety ( sepsis , mortality , or haemorrhage ) , the combined trials are not powered to detect rare adverse events such as heparin-induced thrombocytopaenia |
MS212922 | ***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: Heterogeneity of executive tasks has made it difficult to determine whether there are age-related declines in executive functioning . To address this issue , 112 individuals , 20 - 79 years old , took the California Trail Making Test ( CTMT ) and the California Stroop Test ( CST ) , subtests of the Delis-Kaplan Executive Function Scale ( D. C. Delis , E. Kaplan , & J. H. Kramer , in press ) that include measurement of component skills embedded in the executive function tasks . Multiple regression analyses revealed that after controlling for component skills , age had a significant effect on the executive requirement of the CST , namely speed on the interference condition . Age did not affect switching performance on the letter-number condition of the CTMT . Additional analyses revealed that age was significantly associated with commission of certain types of errors . This study confirms the importance of partialing out components in the assessment of multidimensional cognitive tasks , particularly when making age comparisons . It also emphasizes specificity over generalizability when examining the impact of age on cognition BACKGROUND Subjects with a mild cognitive impairment ( MCI ) have a memory impairment beyond that expected for age and education yet are not demented . These subjects are becoming the focus of many prediction studies and early intervention trials . OBJECTIVE To characterize clinical ly subjects with MCI cross-sectionally and longitudinally . DESIGN A prospect i ve , longitudinal inception cohort . SETTING General community clinic . PARTICIPANTS A sample of 76 consecutively evaluated subjects with MCI were compared with 234 healthy control subjects and 106 patients with mild Alzheimer disease ( AD ) , all from a community setting as part of the Mayo Clinic Alzheimer 's Disease Center/Alzheimer 's Disease Patient Registry , Rochester , Minn. MAIN OUTCOME MEASURES The 3 groups of individuals were compared on demographic factors and measures of cognitive function including the Mini-Mental State Examination , Wechsler Adult Intelligence Scale-Revised , Wechsler Memory Scale-Revised , Dementia Rating Scale , Free and Cued Selective Reminding Test , and Auditory Verbal Learning Test . Clinical classifications of dementia and AD were determined according to the Diagnostic and Statistical Manual of Mental Disorders , Revised Third Edition and the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer 's Disease and Related Disorders Association criteria , respectively . RESULTS The primary distinction between control subjects and subjects with MCI was in the area of memory , while other cognitive functions were comparable . However , when the subjects with MCI were compared with the patients with very mild AD , memory performance was similar , but patients with AD were more impaired in other cognitive domains as well . Longitudinal performance demonstrated that the subjects with MCI declined at a rate greater than that of the controls but less rapidly than the patients with mild AD . CONCLUSIONS Patients who meet the criteria for MCI can be differentiated from healthy control subjects and those with very mild AD . They appear to constitute a clinical entity that can be characterized for treatment interventions Deficits in visual cognition in Alzheimer 's disease ( AD ) arise from neuropathological changes in higher-order association areas of the cortex and from defective input from lower-level visual processing areas . We investigated whether enhanced signal strength may lead to improvement of visual cognition in AD . We tested 35 individuals with probable AD , 35 age-matched elderly control ( EC ) and 58 young control ( YC ) adults on letter identification , word reading , picture naming , discrimination of unfamiliar faces , and pattern completion . The contrast sensitivity step-difference across an independent sample of AD and EC groups was used in calculating an image filter , from which we produced stimulus-strength conditions of low-de grade d , medium-normal , and high-enhanced . Using this filter we created a hypothetical proximal-strength equivalence between AD at medium strength and EC at low strength , and between AD at high strength and EC at medium strength . For letter identification , word reading , picture naming , and face discrimination , medium strength elicited AD accuracy levels and reaction times that were similar to those of EC at low strength . On picture naming , increased strength reduced perceptual-type errors for EC and AD and r and om errors for AD . For word reading , high strength elicited AD accuracy levels and reaction times that were equivalent to those of EC at medium strength . We saw no effect of signal-strength manipulation on performance of pattern completion , possibly owing to the complex cognitive dem and s of that task or to the inadequacy of the filter for its images . The results indicate that putative AD-EC differences in cognition directly reflect contrast sensitivity differences between the groups . Enhancement of stimulus strength can ameliorate vision-based deficits and lead to improvement in some aspects of cognitive performance . These results suggest new non-pharmacological avenues to explore in the attempt to improve cognition in elderly adults and especially in individuals with AD This individual differences study examined the separability of three often postulated executive functions-mental set shifting ( " Shifting " ) , information updating and monitoring ( " Updating " ) , and inhibition of prepotent responses ("Inhibition")- and their roles in complex " frontal lobe " or " executive " tasks . One hundred thirty-seven college students performed a set of relatively simple experimental tasks that are considered to predominantly tap each target executive function as well as a set of frequently used executive tasks : the Wisconsin Card Sorting Test ( WCST ) , Tower of Hanoi ( TOH ) , r and om number generation ( RNG ) , operation span , and dual tasking . Confirmatory factor analysis indicated that the three target executive functions are moderately correlated with one another , but are clearly separable . Moreover , structural equation modeling suggested that the three functions contribute differentially to performance on complex executive tasks . Specifically , WCST performance was related most strongly to Shifting , TOH to Inhibition , RNG to Inhibition and Updating , and operation span to Updating . Dual task performance was not related to any of the three target functions . These results suggest that it is important to recognize both the unity and diversity of executive functions and that latent variable analysis is a useful approach to study ing the organization and roles of executive functions BACKGROUND Modifiable vascular and lifestyle-related risk factors have been associated with dementia risk in observational studies . In the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability ( FINGER ) , a proof-of-concept r and omised controlled trial , we aim ed to assess a multidomain approach to prevent cognitive decline in at-risk elderly people from the general population . METHODS In a double-blind r and omised controlled trial we enrolled individuals aged 60 - 77 years recruited from previous national surveys . Inclusion criteria were CAIDE ( Cardiovascular Risk Factors , Aging and Dementia ) Dementia Risk Score of at least 6 points and cognition at mean level or slightly lower than expected for age . We r and omly assigned participants in a 1:1 ratio to a 2 year multidomain intervention ( diet , exercise , cognitive training , vascular risk monitoring ) , or a control group ( general health advice ) . Computer-generated allocation was done in blocks of four ( two individuals r and omly allocated to each group ) at each site . Group allocation was not actively disclosed to participants and outcome assessors were masked to group allocation . The primary outcome was change in cognition as measured through comprehensive neuropsychological test battery ( NTB ) Z score . Analysis was by modified intention to treat ( all participants with at least one post-baseline observation ) . This trial is registered at Clinical Trials.gov , number NCT01041989 . FINDINGS Between Sept 7 , 2009 , and Nov 24 , 2011 , we screened 2654 individuals and r and omly assigned 1260 to the intervention group ( n=631 ) or control group ( n=629 ) . 591 ( 94 % ) participants in the intervention group and 599 ( 95 % ) in the control group had at least one post-baseline assessment and were included in the modified intention-to-treat analysis . Estimated mean change in NTB total Z score at 2 years was 0·20 ( SE 0·02 , SD 0·51 ) in the intervention group and 0·16 ( 0·01 , 0·51 ) in the control group . Between-group difference in the change of NTB total score per year was 0·022 ( 95 % CI 0·002 - 0·042 , p=0·030 ) . 153 ( 12 % ) individuals dropped out overall . Adverse events occurred in 46 ( 7 % ) participants in the intervention group compared with six ( 1 % ) participants in the control group ; the most common adverse event was musculoskeletal pain ( 32 [ 5 % ] individuals for intervention vs no individuals for control ) . INTERPRETATION Findings from this large , long-term , r and omised controlled trial suggest that a multidomain intervention could improve or maintain cognitive functioning in at-risk elderly people from the general population . FUNDING Academy of Finl and , La Carita Foundation , Alzheimer Association , Alzheimer 's Research and Prevention Foundation , Juho Vainio Foundation , Novo Nordisk Foundation , Finnish Social Insurance Institution , Ministry of Education and Culture , Salama bint Hamdan Al Nahyan Foundation , Axa Research Fund , EVO funding for University Hospitals of Kuopio , Oulu , and Turku and for Seinäjoki Central Hospital and Oulu City Hospital , Swedish Research Council , Swedish Research Council for Health , Working Life and Welfare , and af Jochnick Foundation Objectives To provide estimates of survival after onset of dementia by age , sex , self reported health , disability , and severity of cognitive impairment . Design Analysis of participants from prospect i ve population based cohort study in 1991 - 2003 , with follow-up of dementia status in all individuals after two and six years ( in one centre ) and 10 years and in sub sample s additionally at six and eight years and mortality until 2005 . Setting Multicentre population based study in Engl and and Wales : two rural and three urban centres . Participants 438 participants who developed dementia from a population based study of 13 004 individuals aged 65 years and over drawn from primary care population registers . Main outcome measures Sociodemographic factors , cognitive function , specific health conditions , and self reported health collected at each interview . Cox ’s proportional hazards regression models were used to identify predictors of mortality from the selected variables in people who received diagnosis of dementia according the study ’s criteria . Results By December 2005 , 356 of the 438 ( 81 % ) participants who developed dementia during the study had died . Estimated median survival time from onset of dementia to death was 4.1 years ( interquartile range 2.5 - 7.6 ) for men and 4.6 years ( 2.9 - 7.0 ) for women . There was a difference of nearly seven years in survival between the younger old and the oldest people with dementia : 10.7 ( 25th centile 5.6 ) for ages 65 - 69 ; 5.4 ( interquartile range 3.4 - 8.3 ) for ages 70 - 79 ; 4.3 ( 2.8 - 7.0 ) for ages 80 - 89 , and 3.8 ( 2.3 - 5.2 ) years for ages ≥90 . Significant factors that predicted mortality in the presence of dementia during the follow-up included sex , age of onset , and disability . Conclusion These analyses give a population based estimated median survival for incident dementia of 4.5 years . Such estimates can be used for prognosis and planning for patients , carers , service providers , and policy makers Objectives : To provide up date d estimates of Alzheimer disease ( AD ) dementia prevalence in the United States from 2010 through 2050 . Methods : Probabilities of AD dementia incidence were calculated from a longitudinal , population -based study including substantial numbers of both black and white participants . Incidence probabilities for single year of age , race , and level of education were calculated using weighted logistic regression and AD dementia diagnosis from 2,577 detailed clinical evaluations of 1,913 people obtained from stratified r and om sample s of previously disease-free individuals in a population of 10,800 . These were combined with US mortality , education , and new US Census Bureau estimates of current and future population to estimate current and future numbers of people with AD dementia in the United States . Results : We estimated that in 2010 , there were 4.7 million individuals aged 65 years or older with AD dementia ( 95 % confidence interval [ CI ] = 4.0–5.5 ) . Of these , 0.7 million ( 95 % CI = 0.4–0.9 ) were between 65 and 74 years , 2.3 million were between 75 and 84 years ( 95 % CI = 1.7–2.9 ) , and 1.8 million were 85 years or older ( 95 % CI = 1.4–2.2 ) . The total number of people with AD dementia in 2050 is projected to be 13.8 million , with 7.0 million aged 85 years or older . Conclusion : The number of people in the United States with AD dementia will increase dramatically in the next 40 years unless preventive measures are developed The hypothesis is tested that the response to dextroamphetamine in terms of activity , attention , impulsivity , and autonomic activity is similar in normal ( N ) and hyperactive ( H ) children . Fourteen N and 15 H boys had skin conductance ( SC ) , heart rate ( HR ) , and finger temperature ( ST ) recorded during rest , presentation of eight 75- dB tones , and a reaction time ( RT ) procedure on three occasions : off drug ( Day 1 ) and after ingestion ( double-blind ) of placebo and of .5 mg/kg dextroamphetamine . Both N and H groups showed drug effects , compared to placebo , of reduced motor activity and impulsivity , improved attention ( RT ) , increased HR and HR slowing during R
Output:
| The study highlighted the importance of using st and ard protocol s to evaluate executive dysfunction in Alzheimer 's disease .
The Stroop task allows discriminating better between healthy and pathological aging |
MS212923 | ***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: Differences in the kinematics and pattern of relative regional cerebral blood flow ( rCBF ) during goal -directed arm aim ing were investigated with the use of a Fitts continuous aim ing paradigm with three difficulty conditions ( index of difficulty , ID ) and two aim ing types ( transport vs. targeting ) in six healthy right-h and ed young participants with the use of video-based movement trajectory analysis and positron emission tomography . Movement time and kinematic characteristics were analyzed together with the magnitude of cerebral blood flow to identify areas of brain activity proportionate to task and movement variables . Significant differences in rCBF between task conditions were determined by analysis of variance with planned comparisons of means with the use of group mean weighted linear contrasts . Data were first analyzed for the group . Then individual subject differences for the movement versus no movement and task difficulty comparisons were related to each individual subjects ' anatomy by magnetic resonance imaging . Significant differences in rCBF during reciprocal aim ing compared with no-movement conditions were found in a mosaic of well-known cortical and subcortical areas associated with the planning and execution of goal -directed movements . These included cortical areas in the left sensorimotor , dorsal premotor , and ventral premotor cortices , caudal supplementary motor area ( SMA ) proper , and parietal cortex , and subcortical areas in the left putamen , globus pallidus , red nucleus , thalamus , and anterior cerebellum . As aim ing task difficulty ( ID ) increased , rCBF increased in areas associated with the planning of more complex movements requiring greater visuomotor processing . These included bilateral occipital , left inferior parietal , and left dorsal cingulate cortices -- caudal SMA proper and right dorsal premotor area . These same areas showed significant increases or decreases , respectively , when contrast means were compared with the use of movement time or relative acceleration time , respectively , as the weighting factor . Analysis of individual subject differences revealed a correspondence between the spatial extent of rCBF changes as a function of task ID and the individuals ' movement times . As task ID decreased , significant increases in rCBF were evident in the right anterior cerebellum , left middle occipital gyrus , and right ventral premotor area . Functionally , these areas are associated with aim ing conditions in which the motor execution dem and s are high ( i.e. , coordination of rapid reversals ) and precise trajectory planning is minimal . These same areas showed significant increases or decreases , respectively , when contrast means were compared with the use of movement time or relative acceleration time , respectively , as the weighting factor . A functional dissociation result ed from the weighted linear contrasts between larger ( limb transport ) or smaller ( endpoint targeting ) type amplitude/target width aim ing conditions . Areas with significantly greater rCBF for targeting were the left motor cortex , left intraparietal sulcus , and left cau date . In contrast , those areas with greater rCBF associated with limb transport included bilateral occipital lingual gyri and the right anterior cerebellum . Various theoretical explanations for the speed/accuracy tradeoffs of rapid aim ing movements have been proposed since the original information theory hypothesis of Fitts . This is the first report to relate the predictable variations in motor control under changing task constraints with the functional anatomy of these rapid goal -directed aim ing movements . Differences in unimanual aim ing task difficulty lead to dissociable activation of cortical-subcortical networks . Further , these data suggest that when more precise targeting is required , independent of task difficulty , a cortical-subcortical loop composed of the contralateral motor cortex , intraparietal sulcus , and cau date is activated . This is consistent with the role of motor Purpose : To evaluate the temporal effects of acute exercise on episodic memory . Design : A quasi-experimental study . Sample : Eighty-eight college students ( N = 22 per group ) . Measures : Four experimental groups were evaluated , including a control group , exercising prior to memory encoding , exercising during encoding , and exercising during memory consolidation . The exercise stimulus consisted of a 15-minute moderate-intensity walk on a treadmill . Participants completed the Rey Auditory Verbal Learning Test ( RAVLT ) to assess learning and memory . Prospect i ve memory was assessed via a Red Pen Task . Long-term memory ( recognition and attribution ) of the RAVLT was assessed 20 minutes and 24 hours after exercise . Analysis : Repeated- measures analysis of variance ( ANOVA ) assessed the performance of RAVLT scores of trials 1 to 5 across groups . One-way ANOVA assessed the performance of individual trials across groups , whereas χ2 assessed the performance of the Red Pen Task across groups . Results : Regarding learning , the interaction of groups × trial was marginally statistically significant ( F 12,332 = 1.773 , P = .05 ) , indicating that the group which exercised before encoding did better than the group that exercised during encoding and consolidation . For both 24-hour recognition and attribution performance , the group that exercised before memory encoding performed significantly better than the group that exercised during consolidation ( P = .05 recognition , P = .006 attribution ) . Discussion : Engaging in a 15-minute bout of moderate-intensity walking before a learning task was effective in influencing long-term episodic memory The effects of acute aerobic exercise on cognitive functions in humans have been the subject of much investigation ; however , these studies are limited by several factors , including a lack of r and omized controlled design s , focus on only a single cognitive function , and testing during or shortly after exercise . Using a r and omized controlled design , the present study asked how a single bout of aerobic exercise affects a range of frontal- and medial temporal lobe-dependent cognitive functions and how long these effects last . We r and omly assigned 85 subjects to either a vigorous intensity acute aerobic exercise group or a video watching control group . All subjects completed a battery of cognitive tasks both before and 30 , 60 , 90 , or 120 min after the intervention . This battery included the Hopkins Verbal Learning Test-Revised , the Modified Benton Visual Retention Test , the Stroop Color and Word Test , the Symbol Digit Modalities Test , the Digit Span Test , the Trail Making Test , and the Controlled Oral Word Association Test . Based on these measures , composite scores were formed to independently assess prefrontal cortex- and hippocampal-dependent cognition . A three-way mixed Analysis of Variance was used to determine whether differences existed between groups in the change in cognitive function from pre- to post-intervention testing . Acute exercise improved prefrontal cortex- but not hippocampal-dependent functioning , with no differences found between delay groups . Vigorous acute aerobic exercise has beneficial effects on prefrontal cortex-dependent cognition and these effects can last for up to 2 hr after exercise HIGHLIGHTSAcute exercise following fear conditioning in animals leads to great fear learning . There is no evidence pertaining to the impact of acute exercise on intrusive emotional memories . Acute exercise following encoding of traumatic images led to greater intrusive memories . Findings reinforce animal models of exercise‐induced fear conditioning . ABSTRACT Brief physical exercise enhances memories for neutral events , and recently has been shown to modulate fear learning in animals . To date there is no evidence pertaining to the impact of exercise on emotional memories in humans . Accordingly , this study investigated the role of brief exercise in the development of emotional intrusive memories . Forty‐nine university students ( 18–29 year olds ) viewed a car accident film depicting accident and injury , and were then r and omly assigned to engage in either 10 min of intense exercise or easy walking . Two days following the experiment participants were assessed for both intrusive memories of the film and intentional recall of film details . Results indicated that participants in the exercise relative to the walking condition reported more intrusive memories , but not voluntarily recalled memories , of the car accident film two days later . These findings are consistent with recent evidence of exercise‐induced emotional learning in animals , and point to the potential for physical activity to contribute to the development of intrusions in the context of encoding emotionally‐laden information Persistent long-term memory depends on successful stabilization and integration of new memories after initial encoding [ 1 , 2 ] . This consolidation process is thought to require neuromodulatory factors such as dopamine , noradrenaline , and brain-derived neurotrophic factor [ 3 - 7 ] . Without the release of such factors around the time of encoding , memories will decay rapidly [ 3 , 5 , 6 , 8 ] . Recent studies have shown that physical exercise acutely stimulates the release of several consolidation-promoting factors in humans [ 9 - 14 ] , raising the question of whether physical exercise can be used to improve memory retention [ 15 - 17 ] . Here , we used a single session of physical exercise after learning to exogenously boost memory consolidation and thus long-term memory . Three groups of r and omly assigned participants first encoded a set of picture-location associations . Afterward , one group performed exercise immediately , one 4 hr later , and the third did not perform any exercise . Participants otherwise underwent exactly the same procedures to control for potential experimental confounds . Forty-eight hours later , participants returned for a cued-recall test in a magnetic resonance scanner . With this design , we could investigate the impact of acute exercise on memory consolidation and retrieval-related neural processing . We found that performing exercise 4 hr , but not immediately , after encoding improved the retention of picture-location associations compared to the no-exercise control group . Moreover , performing exercise after a delay was associated with increased hippocampal pattern similarity for correct responses during delayed retrieval . Our results suggest that appropriately timed physical exercise can improve long-term memory and highlight the potential of exercise as an intervention in educational and clinical setting Objective : To systematic ally summarize the experimental effects of exercise on cognitive-related memory function among young to middle-aged adults , which has yet to be done in the literature . Data Source : PubMed . Study Inclusion and Exclusion Criteria : Studies were included if they were published in the English language , indexed in PubMed , employed an experimental study design ( eg , traditional parallel group r and omized controlled trial : either acute intervention or chronic/training intervention study ) , and conducted among human adults . Studies were excluded if nonhumans ( ie , animal models ) were studied , if children/adolescents ( < 18 years ) or older adults ( > 50 years ) were evaluated , and if select chronic diseases ( eg , diabetes and dementia ) were present . Data Extraction : A systematic review approach was employed . Data Synthesis : An extraction table was created synthesizing the key results , and recommendations for future research are emphasized . Results : Among the 17 evaluated studies , 2 were published before the year 2000 ( ie , 1998 and 1999 ) , 2 were published in 2007 , and the remaining 13 were published in the years 2011 and beyond . This highlights the emergence of this research topic within this age-group ( young to middle-aged adults ) . Among the 17 evaluated studies , 14 were conducted among healthy sample s , with 3 conducted among those with a diagnosis of depression . Among the 17 studies , 4 employed a chronic training protocol , with 13 utilizing an acute exercise protocol . Among the 3 experimental studies in the depressed population , all demonstrated a favorable effect of exercise on memory function . Among the 14 trials in the nondepressed population , 10 ( 71 % ) demonstrated a favorable effect of exercise on some aspect of memory function . Conclusion : Acute and chronic exercise appears to play a pronounced effect on memory function among young to middle-aged adults . Implication s and recommendations for future research are outlined in this systematic review The broader purpose of this study was to examine the temporal effects of high-intensity exercise on learning , short-term and long-term retrospective memory and prospect i ve memory . Among a sample of 88 young adult participants , 22 were r and omized into one of four different groups : exercise before learning , control group , exercise during learning , and exercise after learning . The retrospective assessment s ( learning , short-term and long-term memory ) were assessed using the Rey Auditory Verbal Learning Test . Long-term memory including a 20-min and 24-hr follow-up assessment . Prospect i ve memory was assessed using a time-based procedure by having participants contact ( via phone ) the research ers at a follow-up time period . The exercise stimulus included a 15-min bout of progressive maximal exertion treadmill exercise . High-intensity exercise prior to memory encoding ( vs. exercise during memory encoding or consolidation ) was effective in enhancing long-term memory ( for both 20-min and 24-h follow-up assessment s ) . We did not observe a differential temporal effect of high-intensity exercise on short-term memory ( immediate post-memory encoding ) , learning or prospect i ve memory . The timing of high-intensity exercise may play an important role in facilitating long-term memory 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 Abstract Although anecdotal reports suggest that information processing and decision making is impaired immediately following prolonged periods of physical activity , results obtained from laboratory studies of exercise-indu
Output:
| Various study design s and participant characteristics moderated the temporal effects of acute exercise on episodic memory function .
For example , vigorous-intensity acute exercise , and acute exercise among young adults , had greater effects when the acute bout of exercise occurred before memory encoding or during the early memory consolidation period .
Conclusions : The timing of acute exercise plays an important role in the exercise-memory interaction .
Various exercise- and participant-related characteristics moderate this temporal relationship |
MS212924 | ***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: Patients with kidney stones are routinely advised to increase their fluid intake to decrease the risk of stone recurrence . However , there has been no detailed examination to determine whether the effect on recurrence varies by the type of beverage consumed . The authors conducted a prospect i ve study of the relation between the intake of 21 different beverages and the risk of symptomatic kidney stones in a cohort of 45,289 men , 40 - 75 years of age , who had no history of kidney stones . Beverage use and other dietary information was measured by means of a semiquantitative food frequency question naire in 1986 . During 6 years of follow-up ( 242,100 person-years ) , 753 incident cases of kidney stones were documented . After adjusting simultaneously for age , dietary intake of calcium , animal protein and potassium , thiazide use , geographic region , profession , and total fluid intake , consumption of specific beverages significantly added to the prediction of kidney stone risk ( p < 0.001 ) . After mutually adjusting for the intake of other beverages , the risk of stone formation decreased by the following amount for each 240-ml ( 8-oz ) serving consumed daily : caffeinated coffee , 10 % ( 95 % confidence interval 4 - 15 % ) ; decaffeinated coffee , 10 % ( 3 - 16 % ) ; tea , 14 % ( 5 - 22 % ) ; beer , 21 % ( 12 - 30 % ) ; and wine , 39 % ( 10 - 58 % ) . For each 240-ml serving consumed daily , the risk of stone formation increased by 35 % ( 4 - 75 % ) for apple juice and 37 % ( 1 - 85 % ) for grapefruit juice . The authors conclude that beverage type may have an effect on stone formation that involves more than additional fluid intake alone Pomegranate juice ( PJ ; also known as pomegreat pure juice ) provides a rich and varied source of polyphenolic compounds that may offer cardioprotective , anti-atherogenic and antihypertensive effects . The aim of this study was to investigate the effect of PJ consumption on glucocorticoids levels , blood pressure ( BP ) and insulin resistance in volunteers at high CVD risk . Subjects ( twelve males and sixteen females ) participated in a r and omised , placebo-controlled cross-over study ( BMI : 26·77 ( sd 3·36 ) kg/m2 ; mean age : 50·4 ( sd 6·1 ) years ) . Volunteers were assessed at baseline , and at weeks 2 and 4 for anthropometry , BP and pulse wave velocity . Cortisol and cortisone levels in urine and saliva were determined by specific ELISA methods , and the cortisol/cortisone ratio was calculated . Fasting blood sample s were obtained to assess plasma lipids , glucose , insulin and insulin resistance ( homeostasis model assessment of insulin resistance ) . Volunteers consumed 500 ml of PJ or 500 ml of a placebo drink containing a similar amount of energy . Cortisol urinary output was reduced but not significant . However , cortisol/cortisone ratios in urine ( P = 0·009 ) and saliva ( P = 0·024 ) were significantly decreased . Systolic BP decreased from 136·4 ( sd 6·3 ) to 128·9 ( sd 5·1 ) mmHg ( P = 0·034 ) , and diastolic BP from 80·3 ( sd 4·29 ) to 75·5 ( sd 5·17 ) mmHg ( P = 0·031 ) after 4 weeks of fruit juice consumption . Pulse wave velocity decreased from 7·5 ( sd 0·86 ) to 7·44 ( sd 0·94 ) m/s ( P = 0·035 ) . There was also a significant reduction in fasting plasma insulin from 9·36 ( sd 5·8 ) to 7·53 ( sd 4·12 ) mIU/l ( P = 0·025 ) and of homeostasis model assessment of insulin resistance ( from 2·216 ( sd 1·43 ) to 1·82 ( sd 1·12 ) , P = 0·028 ) . No significant changes were seen in the placebo arm of the study . These results suggest that PJ consumption can alleviate key cardiovascular risk factors in overweight and obese subjects that might be due to a reduction in both systolic and diastolic BP , possibly through the inhibition of 11β-hydroxysteroid dehydrogenase type 1 enzyme activity as evidence d by the reduction in the cortisol/cortisone ratio . The reduction in insulin resistance might have therapeutic benefits for patients with non-insulin-dependent diabetes , obesity and the metabolic syndrome OBJECTIVE The objective of the present study was to evaluate the effects of drinking 2 additional litres of water/day on several urinary risk factors for lithiasis in healthy subjects , through measurement of crystallization risk indices ( Tiselius CRI ) . MATERIAL S AND METHODS 48 healthy subjects , aged 25 to 50 were studied for urinary parameters including CRI in the laboratory ward , for 24 hours . After this first period , they were r and omized either to a 2L/d additional water intake ( treated group ) or usual fluid consumption ( control group ) for a 6 days period , which ended by a second measurement period in the laboratory ward for 24 hours . RESULTS Total additional water intake was actually 1.3L/d on average in treated subjects , because subjects decreased other usual sources of fluid intake . In 24 hour urine , Tiselius CRI varied differently among treated subjects and controls between the 2 periods ; male controls subjects experienced much higher values ( above 2 in average in first morning urine sample ) in the second period ( p = 0.05 ) . Of interest , in a transversal analysis , we observed a positive relation between BMI or waist circumference on the one h and , and with 24 hour urea excretion or osmotic load on the other h and . CONCLUSION These results show a beneficial effect of a final 1.3L additional water intake on Tiselius CRI in healthy subjects BACKGROUND A high dietary calcium intake is strongly suspected of increasing the risk of kidney stones . However , a high intake of calcium can reduce the urinary excretion of oxalate , which is thought to lower the risk . The concept that a higher dietary calcium intake increases the risk of kidney stones therefore requires examination . METHODS We conducted a prospect i ve study of the relation between dietary calcium intake and the risk of symptomatic kidney stones in a cohort of 45,619 men , 40 to 75 years of age , who had no history of kidney stones . Dietary calcium was measured by means of a semiquantitative food-frequency question naire in 1986 . During four years of follow-up , 505 cases of kidney stones were documented . RESULTS After adjustment for age , dietary calcium intake was inversely associated with the risk of kidney stones ; the relative risk of kidney stones for men in the highest as compared with the lowest quintile group for calcium intake was 0.56 ( 95 percent confidence interval , 0.43 to 0.73 ; P for trend , < 0.001 ) . This reduction in risk decreased only slightly ( relative risk , 0.66 ; 95 percent confidence interval , 0.49 to 0.90 ) after further adjustment for other potential risk factors , including alcohol consumption and dietary intake of animal protein , potassium , and fluid . Intake of animal protein was directly associated with the risk of stone formation ( relative risk for men with the highest intake as compared with those with the lowest , 1.33 ; 95 percent confidence interval , 1.00 to 1.77 ) ; potassium intake ( relative risk , 0.49 ; 95 percent confidence interval , 0.35 to 0.68 ) and fluid intake ( relative risk , 0.71 ; 95 percent confidence interval , 0.52 to 0.97 ) were inversely related to the risk of kidney stones . CONCLUSIONS A high dietary calcium intake decreases the risk of symptomatic kidney stones We evaluated the possible effects of a calcium entry blocking agent “ verapamil ” on new stone formation and /or regrowth of residual fragments after shock wave lithotripsy ( SWL ) during long-term follow-up ( > 30 months ) and compared the results with the success rates of adequate fluid intake . A total of 70 patients treated with SWL were r and omly divided into three different groups , in the first two of which the patients received different preventive measures with respect to stone recurrence and /or regrowth . While 25 patients received a calcium channel blocking agent , verapamil hydrochloride , beginning 3 days before SWL and continued 4 weeks after the procedure , an additional 25 patients were put in an enforced fluid intake program and the remaining 20 patients received no specific medication and /or measure apart from close follow-up . Patients were followed regularly with respect to the clearance/regrowth of the residual fragments and that of new stone formation during long-term follow-up ( within a mean follow-up of 30.4 months ) . The overall stone recurrence rate was 14 % ( 10/70 ) . Of the patients who became stone free ( 12/25 , 48 % ) in group I , only one patient ( 1/12 , 8.3 % ) showed a new stone formation during long-term follow-up . The figure was 40 % ( 4/10 ) in group II patients and 55 % ( 5/9 ) in group III patients receiving no specific medication . Regarding the residual stone fragments ( < 5 mm ) after SWL , again high fluid intake was found to be the most effective on stone regrowth rates ( 2/13 , 15.3 % ) . Patients treated with verapamil also had acceptable regrowth rates ( 3/15 , 20 % ) . Finally , verapamil treatment significantly improved the clearance of residual fragments ; while 7 out of 15 patients with residual fragments passed these particles successfully , ( 46.5 % ) in this group ; these figures were 46 % ( 6/13 ) and 18 % ( 2/13 ) in the remaining groups . Residual fragments located in lower calyces demonstrated a poor clearance rate with higher regrowth rates . Verapamil administration was found to be effective enough to limit the regrowth of residual fragments and also to facilitate residual fragment clearance after SWL . Patients receiving this medication seemed to pass the retained fragments easily in a shorter time than the others Diet plays an important role in the pathogenesis of kidney stones . Because the metabolism of many dietary factors , such as calcium , may change with age , the relation between diet and kidney stones may be different in older adults . Uncertainty also remains about the association between many dietary factors , such as vitamin C , magnesium , and animal protein , and the risk of kidney stone formation . To examine the association between dietary factors and the risk of incident , symptomatic kidney stones in men and to determine whether these associations vary with age , a prospect i ve cohort study was conducted of 45,619 men without a history of nephrolithiasis . Self-administered food frequency question naires were used to assess diet every 4 yr . A total of 1473 incident symptomatic kidney stones were documented during 477,700 person-years of follow-up . For men aged < 60 yr , the multivariate relative risk ( RR ) for stone formation in the highest quintile of dietary calcium as compared with the lowest quintile was 0.69 ( 95 % confidence interval [ CI ] , 0.56 to 0.87 ; P = 0.01 for trend ) . By contrast , there was no association between dietary calcium and stone formation in men aged 60 yr or older . The multivariate RR for men who consumed 1000 mg or greater of vitamin C per day compared with those who consumed less than the recommended dietary allowance of 90 mg/d was 1.41 ( 95 % CI , 1.11 to 1.80 ; P = 0.01 for trend ) . Other dietary factors showed the following multivariate RR among men in the highest quintile of intake compared with those in the lowest : magnesium , 0.71 ( 95 % CI , 0.56 to 0.89 ; P = 0.01 for trend ) ; potassium , 0.54 ( 95 % CI , 0.42 to 0.68 ; P < 0.001 for trend ) ; and fluid , 0.71 ( 95 % CI , 0.59 to 0.85 ; P < 0.001 for trend ) . Animal protein was associated with risk only in men with a body mass index < 25 kg/m(2 ) ( RR , 1.38 ; 95 % CI , 1.05 to 1.81 ; P = 0.03 for trend ) . Sodium , phosphorus , sucrose , phytate , vitamin B(6 ) , vitamin D , and supplemental calcium were not independently associated with risk . In conclusion , the association between calcium intake and kidney stone formation varies with age . Magnesium intake decreases and total vitamin C intake seems to increase the risk of symptomatic nephrolithiasis . Because age and body size affect the relation between diet and kidney stones , dietary recommendations for stone prevention should be tailored to the individual patient PURPOSE We define the role of urine volume as a stone risk factor in idiopathic calcium
Output:
| The evidence from only one study indicates that increased water intake reduces the risk of recurrence of urinary stones and prolongs the average interval for recurrences .
Due to the lack of appropriate RCTs , no conclusions can be drawn on increased water intake for the primary and secondary prevention of urinary stones |
MS212925 | ***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 Purpose — Fever after stroke is a strong predictor for a negative outcome with infections as the most common cause . The aim of this pilot study was to evaluate the effects of prophylactic antibiotic therapy on the incidence and height of fever after acute ischemic stroke . Methods — This is a r and omized , controlled study of antibiotic prophylaxis in patients with ischemic stroke enrolled within 24 hours from clinical onset who presented bedridden ( modified Rankin score > 3 ) with no significant infection . Interventions included prophylactic mezlocillin plus sulbactam ( 3 × 2 g/1 g for 4 days ) or conventional management . Over 10 days , body temperature was continuously monitored , and the presence of infection was daily assessed . Primary end points were incidence and height of fever ; secondary end points included rate of infection and clinical outcome . Results — Sixty patients were included ( mean , 75 years ; median National Institutes of Health Stroke Scale score , 16 ) . Over the first 3 days , patients in the intervention group showed lower mean body temperatures as well as lower daily peak temperatures ( P<0.05 ) . Throughout the observation period , 15 of 30 patients in the intervention group but 27 of 30 patients in the conventionally treated group developed an infection ( P<0.05 ) . Mean interval until the diagnosis of infection was 5.1 days in the intervention group and 3.3 days in the control group ( P<0.05 ) . Clinical outcome was more favorable in patients with prophylactic therapy ( P=0.01 ) . Conclusions — In patients with acute severe stroke , prophylactic administration of mezlocillin plus sulbactam over 4 days decreases body temperature , lowers the rate of infection , and may be associated with a better clinical outcome BACKGROUND AND PURPOSE This prospect i ve , multicenter study was performed to determine the frequency of symptomatic complications up to 30 months after stroke using prespecified definitions of complications . METHODS We recruited 311 consecutive stroke patients admitted to hospital . Research nurses review ed their progress on a weekly basis until hospital discharge and again at 6 , 18 , and 30 months after stroke . RESULTS Complications during hospital admission were recorded in 265 ( 85 % ) of stroke patients . Specific complications were as follows : neurological-recurrent stroke ( 9 % of patients ) , epileptic seizure ( 3 % ) ; infections-urinary tract infection ( 24 % ) , chest infection ( 22 % ) , others ( 19 % ) ; mobility related-falls ( 25 % ) , falls with serious injury ( 5 % ) , pressure sores ( 21 % ) ; thromboembolism-deep venous thrombosis ( 2 % ) , pulmonary embolism ( 1 % ) ; pain-shoulder pain ( 9 % ) , other pain ( 34 % ) ; and psychological-depression ( 16 % ) , anxiety ( 14 % ) , emotionalism ( 12 % ) , and confusion ( 56 % ) . During follow-up , infections , falls , " blackouts , " pain , and symptoms of depression and anxiety remained common . Complications were observed across all 3 hospital sites , and their frequency was related to patient dependency and duration after stroke . CONCLUSIONS Our prospect i ve cohort study has confirmed that poststroke complications , particularly infections and falls , are common . However , we have also identified complications relating to pain and cognitive or affective symptoms that are potentially preventable and may previously have been underestimated Background and Purpose — Pneumonia has been estimated to occur in about one third of patients after acute stroke . Only limited data are available on stroke-associated pneumonia ( SAP ) in specialized neurological intensive care units ( NICUs ) . Methods — We enrolled 124 patients with acute stroke who were treated at our university hospital NICU in a prospect i ve observational study . Incidence rates and risk factors of SAP and long-term clinical outcome were determined . Results — SAP incidence was 21 % with a spectrum of pathogens , which is comparable to previously published data on general ICU patients . Mechanical ventilation , multiple location , and vertebrobasilar stroke , as well as dysphagia and abnormal chest x-ray findings , were identified as risk factors for the disease . SAP patients showed higher mortality rates than nondiseased subjects ( acute , 26.9 % versus 8.2 % ; long-term , 35.3 % versus 14.3 % ) and a significantly poorer long-term clinical outcome ( Barthel Index , 50.5±42.4 versus 81.5±27.8 ; Rankin Scale , 3.5±1.7 versus 2.2±1.6 ) . Conclusions — Our data underline the considerable epidemiological and prognostic impact of SAP for the treatment of acute stroke patients in a specialized NICU setting . They demonstrate that the occurrence of SAP deteriorates clinical outcome in these patients . Our results allow us to identify high-risk stroke patients at time of NICU admission in whom the use of preventive treatment strategies is most promising BACKGROUND Urinary tract infection ( UTI ) is a recognized complication of stroke . We aim ed to determine the incidence of UTI after acute stroke , the risk factors associated with this complication , and its association with outcome . METHODS Prospect i ve study of consecutive acute stroke patients admitted to an urban teaching hospital . Routine clinical assessment included the modified National Institutes of Health Stroke Scale ( mNIHSS ) and modified Rankin scale ( mRS ) . Patients were followed up for 3 months , including recording of clinician diagnosis of UTI . RESULTS We studied 412 patients ; 65 ( 15.8 % ) were diagnosed with UTI , at a median of 14 days ( IQR = 4 - 39 ) post-stroke . In a binomial multivariate regression analysis , UTI was associated with urinary catheterization ( OR = 3.03 , 95 % CI 1.41 - 6.52 ) , higher mRS ( OR = 1.85 , 1.29 - 2.64 ) and increasing age ( OR = 1.51 , 1.13 - 2.00 for each decade ) . UTI was associated with death or disability at 3 months , however , this link was attenuated and became non-significant when measures of stroke severity and pre-stroke morbidity were included in a multivariate analysis . CONCLUSION UTI is common after acute stroke . It is associated with urinary catheterization , post-stroke disability and increasing age . Avoidance of catheterization might reduce the incidence of this common complication Objectives To provide information on the frequency and reasons for outcome reporting bias in clinical trials . Design Trial protocol s were compared with subsequent publication(s ) to identify any discrepancies in the outcomes reported , and telephone interviews were conducted with the respective trialists to investigate more extensively the reporting of the research and the issue of unreported outcomes . Participants Chief investigators , or lead or co authors of trials , were identified from two sources : trials published since 2002 covered in Cochrane systematic review s where at least one trial analysed was suspected of being at risk of outcome reporting bias ( issue 4 , 2006 ; issue 1 , 2007 , and issue 2 , 2007 of the Cochrane library ) ; and a r and om sample of trial reports indexed on PubMed between August 2007 and July 2008 . Setting Australia , Canada , Germany , the Netherl and s , New Zeal and , the United Kingdom , and the United States . Main outcome measures Frequency of incomplete outcome reporting — signified by outcomes that were specified in a trial ’s protocol but not fully reported in subsequent publications— and trialists ’ reasons for incomplete reporting of outcomes . Results 268 trials were identified for inclusion ( 183 from the cohort of Cochrane systematic review s and 85 from PubMed ) . Initially , 161 respective investigators responded to our requests for interview , 130 ( 81 % ) of whom agreed to be interviewed . However , failure to achieve subsequent contact , obtain a copy of the study protocol , or both meant that final interviews were conducted with 59 ( 37 % ) of the 161 trialists . Sixteen trial investigators failed to report analysed outcomes at the time of the primary publication , 17 trialists collected outcome data that were subsequently not analysed , and five trialists did not measure a prespecified outcome over the course of the trial . In almost all trials in which prespecified outcomes had been analysed but not reported ( 15/16 , 94 % ) , this under-reporting result ed in bias . In nearly a quarter of trials in which prespecified outcomes had been measured but not analysed ( 4/17 , 24 % ) , the “ direction ” of the main findings influenced the investigators ’ decision not to analyse the remaining data collected . In 14 ( 67 % ) of the 21 r and omly selected PubMed trials , there was at least one unreported efficacy or harm outcome . More than a quarter ( 6/21 , 29 % ) of these trials were found to have displayed outcome reporting bias . Conclusion The prevalence of incomplete outcome reporting is high . Trialists seemed generally unaware of the implication s for the evidence base of not reporting all outcomes and protocol changes . A general lack of consensus regarding the choice of outcomes in particular clinical setting s was evident and affects trial design , conduct , analysis , and reporting Background : We have recently shown that ischemic stroke causes a stress-mediator-induced long-lasting immunodepressive state in mice . Methods : Using head magnetic resonance imaging and st and ardized immunoassays , we prospect ively investigated whether poststroke immunodepression is also seen in humans . Results : Compared to healthy volunteers ( n = 30 ) , a rapid depression of lymphocyte counts and a functional deactivation of monocytes and T helper type 1 cells was observed in acute stroke patients ( SP ; n = 40 ) . Immunodepression was more pronounced in patients with severe clinical deficit or large infa rct ion . On admission the combination of monocytic tumor necrosis factor α release ex vivo and the National Institute of Health Stroke Scale score were the best predictors for nosocomial infection , preferentially affecting older SP . Conclusion : Our data provide evidence for an immediate suppression of cell-mediated immune responses after ischemic stroke in humans Objective To determine the incidence rates of hospital acquired infections ( HAI ) during the first 14 days after ICU discharge after treatment during ICU-stay with Selective Decontamination of the Digestive tract ( SDD ) , Selective Oropharyngeal Decontamination ( SOD ) or St and ard Care ( SC ) . Design Prospect i ve observational study . Setting ICUs in two tertiary care hospitals . Patients Patients discharged from the ICU to the ward . Interventions None . Measurements and results Post-ICU incidences of HAI per 1,000 days at risk were 11.2 , 12.9 and 8.3 for patients that had received SDD ( n = 296 ) , SOD ( n = 286 ) or SC ( n = 289 ) respectively in ICU , yielding relative risks , as compared to SC , of 1.49 ( CI95 0.9–2.47 ) for SOD and 1.44 ( CI95 0.87–2.39 ) for SDD . Incidences of surgical site infections ( per 100 surgical procedures ) were 4 after SC and 11.8 and 8 after SOD and SDD ( p = 0.04 ) . Among patients that succumbed in the hospital after ICU-stay ( n = 58 ) eight ( 14 % ) had developed HAI after ICU discharge ; 3 of 21 after SDD , 3 of 15 after SOD and 2 of 22 after SC . Conclusions Incidences of HAI in general wards tended to be higher in patients that had received either SDD or SOD during ICU-stay , but it seems unlikely that these infections have an effect on hospital mortality rates Background Pneumonia is a major risk factor of death after acute stroke . In a mouse model , preventive antibacterial therapy with moxifloxacin not only prevents the development of post-stroke infections , it also reduces mortality , and improves neurological outcome significantly . In this study we investigate whether this approach is effective in stroke patients . Methods Preventive ANtibacterial THERapy in acute Ischemic Stroke ( PANTHERIS ) is a r and omized , double-blind , placebo-controlled trial in 80 patients with severe , non-lacunar , ischemic stroke ( NIHSS>11 ) in the middle cerebral artery ( MCA ) territory . Patients received either intravenous moxifloxacin ( 400 mg daily ) or placebo for 5 days starting within 36 hours after stroke onset . Primary endpoint was infection within 11 days . Secondary endpoints included neurological outcome , survival , development of stroke-induced immunodepression , and induction of bacterial resistance . Findings On intention-to treat analysis ( 79 patients ) , the infection rate at day 11 in the moxifloxacin treated group was 15.4 % compared to 32.5 % in the placebo treated group ( p = 0.114 ) . On per protocol analysis ( n = 66 ) , moxifloxacin significantly reduced infection rate from 41.9 % to 17.1 % ( p = 0.032 ) . Stroke associated infections were associated with a lower survival rate . In this study , neurological outcome and survival were not significantly influenced by treatment with moxifloxacin . Frequency of fluoroquinolone resistance in both treatment groups did not differ . On logistic regression analysis , treatment arm as well as the interaction between treatment arm and monocytic HLA-DR expression ( a marker for
Output:
| In the previous version of this Cochrane Review , published in 2012 , we found that antibiotics did reduce the risk of infection but did not reduce the number of dependent or deceased patients .
AUTHORS ' CONCLUSIONS Preventive antibiotics had no effect on functional outcome or mortality , but significantly reduced the risk of ' overall ' infections .
This reduction was driven mainly by prevention of urinary tract infection ; no effect for pneumonia was found |
MS212926 | ***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 Fatigue or lack of interest can reduce the feasibility of intensive physical exercise in nursing home residents . Low-volume exercise interventions with similar training effects might be an alternative . The aim of this r and omised controlled trial was to investigate the feasibility of Whole Body Vibration ( WBV ) in institutionalised elderly , and its impact on functional capacity and muscle performance . Methods Twenty-four nursing home residents ( 15 female , 9 male ; mean age 77.5 ± 11.0 years ) were r and omised ( stratification for age , gender and ADL-category ) to 6 weeks static WBV exercise ( WBV+ , N = 13 ) or control ( only static exercise ; N = 11 ) . Outcome measures were exercise compliance , timed up- and -go , Tinetti-test , back scratch , chair sit- and -reach , h and grip strength and linear isokinetic leg extension . Results At baseline , WBV+ and control groups were similar for all outcome variables . Twenty-one participants completed the program and attended respectively 96 % and 86 % of the exercise sessions for the WBV+ and control groups . Training-induced changes in timed up- and -go and Tinetti-test were better for WBV+ compared to control ( p = 0.029 for timed up- and -go , p = 0.001 and p = 0.002 for Tinetti body balance and total score respectively ) . In an alternative analysis ( Worst Rank Score & Last Observation Carried Forward ) the differences in change remained significant on the Tinetti body balance and total score . No other significant differences in change between both groups were observed . Conclusion In nursing home residents with limited functional dependency , six weeks static WBV exercise is feasible , and is beneficial for balance and mobility . The supplementary benefit of WBV on muscle performance compared to classic exercise remains to be explored further 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 It is well known that applying vibrations to men influences multiple physiological functions . The authors analysed post effects of whole-body-vibration ( WBV ) on motor symptoms in Parkinson 's disease ( PD ) . Sixty-eight persons with PD were r and omly subdivided into one experimental and one control group . Motor symptoms were assessed by the UPDRS ( Unified Parkinson 's Disease Rating Scale ) motor score . A cross-over design was used to control treatment effects . The treatment consisted of 5 series of whole-body-vibration taking 60 seconds each . On average a highly significant ( p<0.01 ) improvement of 16.8 % in the UPDRS motor score was found in the treatment group . Only marginal changes ( p>0.05 ) were found in the control group . The cross-over procedure showed comparable treatment effects ( 14.7 % improvement after treatment ) . With respect to different symptom clusters only small changes were found in limb akinesia and cranial symptoms . By contrast , tremor and rigidity scores were improved by 25 % and 24 % , respectively . According to the structure of symptom changes it is unlikely that these effects are explainable on peripheral sensory level , exclusively . With respect to the findings of other studies one can speculate about changes in activation of the supplementary motor area and in neurotransmitter functions OBJECTIVE To investigate the efficacy of high-frequency whole-body vibration ( WBV ) on balancing ability in elderly women . DESIGN R and omized controlled trial . Subjects were r and omized to either the WBV intervention or the no-treatment control group . SETTING Community-living elderly women . PARTICIPANTS Sixty-nine elderly women aged 60 or above without habitual exercise . INTERVENTION Side alternating WBV at 20Hz with 3 minutes a day and 3 days a week for 3 months in the WBV intervention group . Those in control group remained sedentary with normal daily life for the whole study period . MAIN OUTCOME MEASURES Limits of stability in terms of reaction time , movement velocity , directional control , endpoint excursion , maximum excursion , and the functional reach test were performed at baseline and endpoint . RESULTS Significant enhancement of stability was detected in movement velocity ( P<.01 ) , maximum point excursion ( P<.01 ) , in directional control ( P<.05 ) . CONCLUSIONS WBV was effective in improving the balancing ability in elderly women . This also provides evidence to support our user-friendly WBV treatment protocol of 3 minutes a day for the elderly to maintain their balancing ability and reduce risks of fall OBJECTIVES To investigate the effects of 24 weeks of whole-body-vibration ( WBV ) training on knee-extension strength and speed of movement and on counter-movement jump performance in older women . DESIGN A r and omized , controlled trial . SETTING Exercise Physiology and Biomechanics Laboratory , Leuven , Belgium . PARTICIPANTS Eighty-nine postmenopausal women , off hormone replacement therapy , aged 58 to 74 , were r and omly assigned to a WBV group ( n=30 ) , a resistance-training group ( RES , n=30 ) , or a control group ( n=29 ) . INTERVENTION The WBV group and the RES group trained three times a week for 24 weeks . The WBV group performed unloaded static and dynamic knee-extensor exercises on a vibration platform , which provokes reflexive muscle activity . The RES group trained knee-extensors by performing dynamic leg-press and leg-extension exercises increasing from low ( 20 repetitions maximum ( RM ) ) to high ( 8RM ) resistance . The control group did not participate in any training . MEASUREMENTS Pre- , mid- ( 12 weeks ) , and post- ( 24 weeks ) isometric strength and dynamic strength of knee extensors were measured using a motor-driven dynamometer . Speed of movement of knee extension was assessed using an external resistance equivalent to 1 % , 20 % , 40 % , and 60 % of isometric maximum . Counter-movement jump performance was determined using a contact mat . RESULTS Isometric and dynamic knee extensor strength increased significantly ( P<.001 ) in the WBV group ( mean+/-st and ard error 15.0+/-2.1 % and 16.1+/-3.1 % , respectively ) and the RES group ( 18.4+/-2.8 % and 13.9+/-2.7 % , respectively ) after 24 weeks of training , with the training effects not significantly different between the groups ( P=.558 ) . Speed of movement of knee extension significantly increased at low resistance ( 1 % or 20 % of isometric maximum ) in the WBV group only ( 7.4+/-1.8 % and 6.3+/-2.0 % , respectively ) after 24 weeks of training , with no significant differences in training effect between the WBV and the RES groups ( P=.391 ; P=.142 ) . Counter-movement jump height enhanced significantly ( P<.001 ) in the WBV group ( 19.4+/-2.8 % ) and the RES group ( 12.9+/-2.9 % ) after 24 weeks of training . Most of the gain in knee-extension strength and speed of movement and in counter-movement jump performance had been realized after 12 weeks of training . CONCLUSION WBV is a suitable training method and is as efficient as conventional RES training to improve knee-extension strength and speed of movement and counter-movement jump performance in older women . As previously shown in young women , it is suggested that the strength gain in older women is mainly due to the vibration stimulus and not only to the unloaded exercises performed on the WBV platform OBJECTIVE To test whether training on a high-frequency ( 28Hz ) vibrating platform improves muscle power and bone characteristics in postmenopausal women . DESIGN R and omized controlled trial with 6-month follow-up . SETTING Outpatient clinic in a general hospital in Italy . PARTICIPANTS Twenty-nine postmenopausal women ( intervention group , n=14 ; matched controls , n=15 ) . INTERVENTION Participants stood on a ground-based oscillating platform for three 2-minute sessions for a total of 6 minutes per training session , twice weekly for 6 months . The controls did not receive any training . Both groups were evaluated at baseline and after 6 months . MAIN OUTCOME MEASURES Muscle power , calculated from ground reaction forces produced by l and ing after jumping as high as possible on a forceplate , cortical bone density , and biomarkers of bone turnover . RESULTS Over 6 months , muscle power improved by about 5 % in women who received the intervention , and it remained unchanged in controls ( P=.004 ) . Muscle force remained stable in both the intervention and control groups . No significant changes were observed in bone characteristics . CONCLUSION Reflex muscular contractions induced by vibration training improve muscle power in postmenopausal women Background Whole-body vibration ( WBV ) is a new type of exercise that has been increasingly tested for the ability to prevent bone fractures and osteoporosis in frail people . There are two currently marketed vibrating plates : a ) the whole plate oscillates up and down ; b ) reciprocating vertical displacements on the left and right side of a fulcrum , increasing the lateral accelerations . A few studies have shown recently the effectiveness of the up- and -down plate for increasing Bone Mineral Density ( BMD ) and balance ; but the effectiveness of the reciprocating plate technique remains mainly unknown . The aim was to compare the effects of WBV using a reciprocating platform at frequencies lower than 20 Hz and a walking-based exercise programme on BMD and balance in post-menopausal women . Methods Twenty-eight physically untrained post-menopausal women were assigned at r and om to a WBV group or a Walking group . Both experimental programmes consisted of 3 sessions per week for 8 months . Each vibratory session included 6 bouts of 1 min ( 12.6 Hz in frequency and 3 cm in amplitude with 60 ° of knee flexion ) with 1 min rest between bouts . Each walking session was 55 minutes of walking and 5 minutes of stretching . Hip and lumbar BMD ( g·cm-2 ) were measured using dual-energy X-ray absorptiometry and balance was assessed by the blind flamingo test . ANOVA for repeated measurements was adjusted by baseline data , weight and age . Results After 8 months , BMD at the femoral neck in the WBV group was increased by 4.3 % ( P = 0.011 ) compared to the Walking group . In contrast , the BMD at the lumbar spine was unaltered in both groups . Balance was improved in the WBV group ( 29 % ) but not in the Walking group . Conclusion The 8-month course of vibratory exercise using a reciprocating plate is feasible and is more effective than walking to improve two major determinants of bone fractures : hip BMD and balance This study was design ed to investigate the effects of vibration on muscle performance and mobility in a healthy , untrained , older population . Forty-three participants ( 23 men , 20 women , 66 - 85 y old ) performed tests of sit-to-st and ( STS ) , 5- and 10-m fast walk , timed up- and -go test , stair mobility , and strength . Participants were r and omly assigned to a vibration group , an exercise-withoutvibration group , or a control group . Training consisted of 3 sessions/wk for 2 mo . After training , the vibration and exercise groups showed improved STS ( 12.4 % , 10.2 % ) , 5-m fast walk ( 3.0 % , 3.7 % ) , and knee-extension strength ( 8.1 % , 7.2 % ) compared with the control ( p < 0.05 ) . Even though vibration training improved lower limb strength , it did not appear to have a facilitatory effect on functional-performance tasks compared with the exercise-without-vibration group . Comparable mobility and performance changes between the experimental groups suggest that improvements are linked with greater knee-extension strength and largely attributed to the unloaded squats performed by both exercise groups To determine whether 10 weeks of whole-body vibration ( WBV ) training has a significant effect on strength , muscle mass , muscle power , and mobility in older women , 26 subjects were r and omly assigned to a WBV training group ( n=13 ; mean age 79 years ) and a control ( CON ) group ( n=13 ; mean age 76 years ) . Maximal voluntary isometric
Output:
| In multiple sclerosis there was no evidence of a short-term or long-term effect of WBV on body balance , gait , muscle performance or quality of life .
AUTHORS ' CONCLUSIONS There is insufficient evidence of the effect of WBV training on functional performance of neurodegenerative disease patients .
Also , there is insufficient evidence regarding its beneficial effects on signs and symptoms of the disease , body balance , gait , muscle strength and quality of life compared to other active physical therapy or passive interventions in Parkinson 's disease or multiple sclerosis . |
MS212927 | ***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 objective of this study was to assess the effect of health education in the control of bilharziasis , as a part of an investigation on anti-urinary bilharziasis campaign in Niger . We carried out a survey in two groups of endemic villages on the Niger , one group of villages where there are health education campaigns ( target villages ) and a control village ( no education campaign ) . Five hundred and seventy-seven people were interviewed in the area . The bilharziasis project has been the main source of information on bilharziasis of people in the project zone . The awareness of measures to fight against bilharziasis has been moderate . Indeed , 46.6 % of people interrogated in the project area could n't cite any means for containing bilharziasis . In the area of intervention , 41.5 % of people interrogated were unaware of the intervention of an intermediate host in the transmission of the urinary bilharziasis . The notion of reinfestation remains little known . Behaviours that favour the illness were ignored by 1/3 of people interrogated in the project area . However , there was an increase in knowledge about the illness in the program zone in comparison with the control area . Despite the increase in knowledge level , changes in behaviour in relation to the illness remained low . Risky behaviour continued in about 2/3 of people interrogated . Only 33 % of persons of the project area declared having adopted at least a single good behaviour . Changes of behaviour are slow to take place . Activities of health education must be sustained throughout a long period of time for sustainable profits of control actions to occur Over a period of one school year a study was carried out into the feasibility and effectiveness of introducing active teaching methods into primary schools in Tanzania with a view to enhancing health education . The Lushoto Enhanced Health Education Project had as a focus personal hygiene with reference to the control of schistosomiasis and helminth infections . When a r and omly selected group of children were compared with a comparison group there was evidence of changes in both knowledge and health-seeking behaviour . The passing of messages from children to the community met with mixed results . The observed changes were still evident over 1 year after the project had ended Objective : To determine the association between female genital Schistosoma haematobium infection and HIV . Design and methods : A cross-sectional study with a 1-year follow-up . Gynecological and laboratory investigations were performed for S. haematobium and HIV . Sexually transmitted infections , demographic and urogenital history were analysed as confounders . The participants were 527 sexually active , non-pregnant , non-menopausal women between the ages of 20 and 49 years . The setting was a rural Zimbabwean community where S. haematobium related lesions were found in 46 % of the women , HIV in 29 % and herpes simplex type- 2 ( HSV-2 ) in 65 % . Results : In permanent residents ( > 3 years residency ) , HIV was found in 41 % ( 29/70 ) of women with laboratory proven genital schistosomiasis as opposed to 26 % HIV positive ( 96/375 ) in the schistosomal ova negative group [ odds ratio ( OR ) , 2.1 ; 95 % confidence interval ( CI ) , 1.2–3.5 ; P = 0.008 . In multivariate analysis S. haematobium infection of the genital mucosa was significantly associated with HIV seropositivity ( adjusted OR , 2.9 ; 95 % CI , 1.11–7.5 ; P = 0.030 ) . All seven women who became HIV positive during the study period ( seroincidence 3.1 % ) had signs of S. haematobium at baseline . In accordance with other studies HIV was significantly associated with HSV-2 ( OR , 3.0 ; 95 % CI , 1.7–5.3 ; P < 0.001 ) , syphilis and human papillomavirus . The highest HIV prevalence ( 45 % ) was found in the 25–29 years age group . Conclusion : Women with genital schistosomiasis had an almost three-fold risk of having HIV in this rural Zimbabwean community . Prospect i ve studies are needed to confirm the association
Output:
| The findings from this review suggest that health education has a beneficial impact on knowledge and underst and ing of schistosomiasis within the target groups . |
MS212928 | ***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 European Society of Urogenital Radiology has built the Prostate Imaging Reporting and Data System ( PI-RADS ) for st and ardizing the diagnosis of prostate cancer ( PCa ) . This study evaluated the PI-RADS diagnosis method in patients with prostate-specific antigen ( PSA ) < 20 ng/ml . Methods : A total of 133 patients with PSA < 20 ng/ml were prospect ively recruited . T2-weighted ( T2WI ) and diffusion-weighted ( DWI ) magnetic resonance images of the prostate were acquired before a 12-core transrectal prostate biopsy . Each patient 's peripheral zone was divided into six regions on the images ; each region corresponded to two of the 12 biopsy cores . T2WI , DWI , and T2WI + DWI scores were computed according to PI-RADS . The diagnostic accuracy of the PI-RADS score was evaluated using histopathology of prostate biopsies as the reference st and ard . Results : PCa was histologically diagnosed in 169 ( 21.2 % ) regions . Increased PI-RADS score correlated positively with increased cancer detection rate . The cancer detection rate for scores 1 to 5 was 2.8 % , 15.0 % , 34.6 % , 52.6 % , and 88.9 % , respectively , using T2WI and 12.0 % , 20.2 % , 48.0 % , 85.7 % , and 93.3 % , respectively , using DWI . For T2WI + DWI , the cancer detection rate was 1.5 % ( score 2 ) , 13.5 % ( scores 3–4 ) , 41.3 % ( scores 5–6 ) , 75.9 % ( scores 7–8 ) , and 92.3 % ( scores 9–10 ) . The area under the curve for cancer detection was 0.700 ( T2WI ) , 0.735 ( DWI ) and 0.749 ( T2WI + DWI ) . The sensitivity and specificity were 53.8 % and 89.2 % , respectively , when using scores 5–6 as the cutoff value for T2WI + DWI . Conclusions : The PI-RADS score correlates with the PCa detection rate in patients with PSA < 20 ng/ml . The summed score of T2WI + DWI has the highest accuracy in detection of PCa . However , the sensitivity should be further improved PURPOSE In patients with a negative prostate biopsy and persistent suspicion of prostate cancer , additional analyses such as the PCA3 score , PHI and multiparametric magnetic resonance imaging have been proposed to reduce the number of unnecessary repeat biopsies . In this study we evaluate the diagnostic accuracy of PCA3 , PHI , multiparametric magnetic resonance imaging and various combinations of these tests in the repeat biopsy setting . MATERIAL S AND METHODS A total of 170 patients with an initial negative prostate biopsy and persistent suspicion of prostate cancer were enrolled in this prospect i ve study . The patients underwent measurements of the total prostate specific antigen and free prostate specific antigen rate , along with PHI , PCA3 tests and multiparametric magnetic resonance imaging before st and ard repeat biopsy that was performed by urologists blinded to the multiparametric magnetic resonance imaging results . Multivariate logistic regression models with various combinations of PCA3 , PHI and multiparametric magnetic resonance imaging were used to identify the predictors of prostate cancer with repeat biopsy , and the performance of these models was compared using ROC curves , AUC analysis and decision curve analysis . RESULTS In the ROC analysis the most significant contribution was provided by multiparametric magnetic resonance imaging ( AUC 0.936 ) , which was greater than the contribution of the PHI+PCA3 model ( p < 0.001 ) . In the multivariate logistic regression analysis only multiparametric magnetic resonance imaging was a significant independent predictor of prostate cancer diagnosis with repeat biopsy ( p < 0.001 ) . The results of the decision curve analysis confirmed that the most significant improvement in the net benefit was provided by multiparametric magnetic resonance imaging . CONCLUSIONS Multiparametric magnetic resonance imaging provides high diagnostic accuracy in identifying patients with prostate cancer in the repeat biopsy setting compared with PCA3 and PHI PURPOSE To evaluate the role of a 3 T biparametric magnetic resonance imaging ( bpMRI ) , T2 -weighted imaging , and three separate diffusion-weighted imaging acquisitions combined with targeted biopsy ( TB ) for improving risk stratification of men with elevated prostate-specific antigen ( PSA ) . MATERIAL S AND METHODS Between March 2013 and February 2015 , 175 men with a clinical suspicion of prostate cancer ( PCa ) were offered bpMRI ( NCT01864135 ) based on a suspicion of PCa ( two repeated PSA measurements in the range 2.5 - 20.0 ng/ml and /or abnormal digital rectal examination ) . Men with an equivocal to high suspicion of PCa had two TBs of the dominant lesion using cognitive ultrasound guidance , followed by systematic biopsy ( SB ) . Men with a low to very low suspicion had only SB . In total , 161 ( 161/175 , 92 % ) prospect ively enrolled men completed the trial and were included in the final analyses . The primary endpoint of the trial was the cancer detection rate ( CDR ) of TB and SB . Clinical ly significant cancer ( SPCa ) was defined as Gleason score ≥3 + 4 . RESULTS TB compared with SB had higher CDR for SPCa ( 45 % , 72/161 vs. 39 % , 63/161 , respectively ; P > 0.05 ) and a lower CDR for Gleason score 3 + 3 ( 8 % , 15/161 vs. 16 % , 30/161 ; P < 0.05 ) . Restricting biopsy to men with equivocal to highly suspicious bpMRI findings would have result ed in a 24 % ( 38/161 ) reduction in the number of men undergoing biopsy , while missing 4 ( 2 % ) with SPCa . All anonymized data sets , including bpMRI reports and follow up information , are freely available on the trial server . CONCLUSION Prebiopsy bpMRI and TB in men with a clinical suspicion of PCa improved risk stratification . LEVEL OF EVIDENCE 1 Technical Efficacy : Stage 5 J. Magn . Reson . Imaging 2017;46:1089 - 1095 OBJECTIVE Multiparametric MRI ( mp-MRI ) of the prostate is increasingly being used for local staging and detection of recurrence of prostate cancer ( PCA ) . In patients with elevated prostate-specific antigen ( PSA ) , mp-MRI could provide information on the position of the cancer , allowing adjustments to be made to the needle depth and direction before repeat transrectal ultrasound (TRUS)-guided biopsy to ensure accurate sampling of lesions . The purpose of the prospect i ve study was to evaluate mp-MRI of the prostate in patients with PSA elevation before initial TRUS-guided biopsy . METHODS mp-MRI was performed in 94 patients using a 1.5-T scanner ( MAGNETOM Aera ( ® ) ; Siemens Healthcare , Erlangen , Germany ) and 16-channel phased-array body coil ( Siemens Healthcare ) . T2 weighted images ( T2WI ) , diffusion-weighted imaging ( DWI ) , dynamic contrast-enhanced ( DCE ) MRI and MR spectroscopy were obtained . TRUS-guided r and om biopsies and additional targeted biopsies of suspicious MRI areas were performed . RESULTS Additional targeted biopsies were obtained in 17 of 43 ( 40 % ) patients with PCA . 11 of 17 targeted biopsies contained PCA . 5 of 11 PCAs were diagnosed only by additional targeted biopsies . Sensitivity of mp-MRI in patients was 97.7 % and specificity was 11.8 % . mp-MRI was false negative in one patient . Sensitivity of mp-MRI in 207 lesions was 80.9 % and specificity was 44.7 % . In a logistic regression model , the apparent diffusion coefficient value was the only significant parameter to differentiate malignant and benign lesions . CONCLUSION mp-MRI should be performed in patients with PSA elevation before initial TRUS-guided biopsy to allow additional targeted biopsies from suspicious areas of MRI . We recommend mp-MRI with T2WI , DWI , DCE MRI and MR spectroscopy . DWI as the most reliable technique should be used in every mp-MRI . ADVANCES IN KNOWLEDGE DWI is the most reliable technique in mp-MRI of the prostate Purpose To vali date the dominant pulse sequence paradigm and limited role of dynamic contrast material -enhanced magnetic resonance ( MR ) imaging in the Prostate Imaging Reporting and Data System ( PI-RADS ) version 2 for prostate multiparametric MR imaging by using data from a multireader study . Material s and Methods This HIPAA-compliant retrospective interpretation of prospect ively acquired data was approved by the local ethics committee . Patients were treatment-naïve with endorectal coil 3-T multiparametric MR imaging . A total of 163 patients were evaluated , 110 with prostatectomy after multiparametric MR imaging and 53 with negative multiparametric MR imaging and systematic biopsy findings . Nine radiologists participated in this study and interpreted images in 58 patients , on average ( range , 56 - 60 patients ) . Lesions were detected with PI-RADS version 2 and were compared with whole-mount prostatectomy findings . Probability of cancer detection for overall , T2-weighted , and diffusion-weighted ( DW ) imaging PI-RADS scores was calculated in the peripheral zone ( PZ ) and transition zone ( TZ ) by using generalized estimating equations . To determine dominant pulse sequence and benefit of dynamic contrast-enhanced ( DCE ) imaging , odds ratios ( ORs ) were calculated as the ratio of odds of cancer of two consecutive scores by logistic regression . Results A total of 654 lesions ( 420 in the PZ ) were detected . The probability of cancer detection for PI-RADS category 2 , 3 , 4 , and 5 lesions was 15.7 % , 33.1 % , 70.5 % , and 90.7 % , respectively . DW imaging outperformed T2-weighted imaging in the PZ ( OR , 3.49 vs 2.45 ; P = .008 ) . T2-weighted imaging performed better but did not clearly outperform DW imaging in the TZ ( OR , 4.79 vs 3.77 ; P = .494 ) . Lesions classified as PI-RADS category 3 at DW MR imaging and as positive at DCE imaging in the PZ showed a higher probability of cancer detection than did DCE-negative PI-RADS category 3 lesions ( 67.8 % vs 40.0 % , P = .02 ) . The addition of DCE imaging to DW imaging in the PZ was beneficial ( OR , 2.0 ; P = .027 ) , with an increase in the probability of cancer detection of 15.7 % , 16.0 % , and 9.2 % for PI-RADS category 2 , 3 , and 4 lesions , respectively . Conclusion DW imaging outperforms T2-weighted imaging in the PZ ; T2-weighted imaging did not show a significant difference when compared with DW imaging in the TZ by PI-RADS version 2 criteria . The addition of DCE imaging to DW imaging scores in the PZ yields meaningful improvements in probability of cancer detection . © RSNA , 2017 An earlier incorrect version of this article appeared online . This article was corrected on July 27 , 2017 . Online supplemental material is available for this article Purpose To determine the diagnostic accuracy for clinical ly significant prostate cancer achieved with abbreviated biparametric prostate magnetic resonance ( MR ) imaging in comparison with full multiparametric contrast material -enhanced prostate MR imaging in men with elevated prostate-specific antigen ( PSA ) and negative transrectal ultrasonography (US)-guided biopsy findings ; to determine the significant cancer detection rate of biparametric versus full multiparametric contrast-enhanced MR imaging and between-reader agreement for interpretation of biparametric MR imaging . Material s and Methods In this institutional review board-approved retrospective review of prospect ively acquired data , men with PSA greater than or equal to 3 ng/mL after negative transrectal US-guided biopsy findings underwent state-of-the-art , full multiparametric contrast-enhanced MR imaging at 3.0-T including high-spatial-resolution structural imaging in several planes , diffusion-weighted imaging at 0 , 800 , 1000 , and 1400 mm2/sec , and dynamic contrast-enhanced MR imaging , obtained without endorectal coil within 34 minutes 19 seconds . One of four radiologists with different levels of expertise ( 1 - 9 years ) first review ed only a fraction of the full multiparametric contrast-enhanced MR images , consisting of single-plane ( axial ) structural imaging ( T2-weighted turbo spin-echo and diffusion-weighted imaging ) , acquired within 8 minutes 45 seconds ( referred to as biparametric MR imaging ) , and established a diagnosis according to the Prostate Imaging Reporting and
Output:
| Results of the meta- analysis suggest that mpMRI is a sensitive tool to diagnose prostate cancer . |
MS212929 | ***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: BACKGROUND Biventricular ( BiV ) stimulation is the preferred means of delivering cardiac resynchronization therapy ( CRT ) , although left ventricular (LV)-only stimulation might be as safe and effective . B-LEFT HF is a prospect i ve , multicenter , r and omized , double-blind study aim ed to examine whether LV-only is noninferior to BiV pacing regarding clinical and echocardiographic responses . METHODS B-LEFT HF r and omly assigned 176 CRT-D recipients , in New York Heart Association class III or IV , with an LV ejection fraction < or = 35 % and QRS > or = 130 milliseconds , to a BiV ( n = 90 ) versus LV ( n = 86 ) stimulation group . Clinical status and echocardiograms were analyzed at baseline and 6 months after CRT-D implant to test the noninferiority of LV-only compared with BiV stimulation . RESULTS The proportion of responders was in line with current literature on CRT , with improvement in heart failure composite score in 76.2 % and 74.7 % of patients in BiV and LV groups , respectively . Comparing LV versus BiV pacing , the small differences in response rates and corresponding 95 % CI indicated that LV pacing was noninferior to BiV pacing for a series of response criteria ( combination of improvement in New York Heart Association and reverse remodeling , improvement in heart failure composite score , reduction in LV end-systolic volume of at least 10 % ) , both at intention-to-treat and at per- protocol analysis . CONCLUSIONS Left ventricular-only pacing is noninferior to BiV pacing in a 6-month follow-up with regard to clinical and echocardiographic responses . Left ventricular pacing may be considered as a clinical alternative option to BiV pacing Aims The choice of resynchronization therapy between with ( CRT-D ) and without ( CRT-P ) a defibrillator remains a contentious issue . Cause-of-death analysis among CRT-P , compared with CRT-D , patients could help evaluate the extent to which CRT-P patients would have additionally benefited from a defibrillator in a daily clinical practice . Methods and results A total of 1705 consecutive patients implanted with a CRT ( CRT-P : 535 and CRT-D : 1170 ) between 2008 and 2010 were enrolled in CeRtiTuDe , a multicentric prospect i ve follow-up cohort study , with specific adjudication for causes of death at 2 years . Patients with CRT-P compared with CRT-D were older ( P < 0.0001 ) , less often male ( P < 0.0001 ) , more symptomatic ( P = 0.0005 ) , with less coronary artery disease ( P = 0.003 ) , wider QRS ( P = 0.002 ) , more atrial fibrillation ( P < 0.0001 ) , and more co-morbidities ( P = 0.04 ) . At 2-year follow-up , the annual overall mortality rate was 83.80 [ 95 % confidence interval ( CI ) 73.41–94.19 ] per 1000 person-years . The crude mortality rate among CRT-P patients was double compared with CRT-D ( relative risk 2.01 , 95 % CI 1.56–2.58 ) . In a Cox proportional hazards regression analysis , CRT-P remained associated with increased mortality ( hazard ratio 1.54 , 95 % CI 1.07–2.21 , P = 0.0209 ) , although other potential confounders may persist . By cause-of-death analysis , 95 % of the excess mortality among CRT-P subjects was related to an increase in non-sudden death . Conclusion When compared with CRT-D patients , excess mortality in CRT-P recipients was mainly due to non-sudden death . Our findings suggest that CRT-P patients , as currently selected in routine clinical practice , would not potentially benefit with the addition of a defibrillator Background — The Sudden Cardiac Death in Heart Failure Trial ( SCD-HeFT ) demonstrated that implantable cardioverter-defibrillator ( ICD ) therapy reduces all-cause mortality in patients with New York Heart Association class II/III heart failure and a left ventricular ejection fraction ≤35 % on optimal medical therapy . Whether ICD therapy reduced sudden death caused by ventricular tachyarrhythmias without affecting heart failure deaths in this population is unknown . Methods and Results — SCD-HeFT r and omized 2521 subjects to placebo , amiodarone , or shock-only , single-lead ICD therapy . Over a median follow-up of 45.5 months , a total of 666 deaths occurred , which were review ed by an Events Committee and initially categorized as cardiac or noncardiac . Cardiac deaths were further adjudicated as result ing from sudden death presumed to be ventricular tachyarrhythmic , bradyarrhythmia , heart failure , or other cardiac causes . ICD therapy significantly reduced cardiac mortality compared with placebo ( adjusted hazard ratio , 0.76 ; 95 % confidence interval , 0.60 to 0.95 ) and tachyarrhythmia mortality ( adjusted hazard ratio , 0.40 ; 95 % confidence interval , 0.27 to 0.59 ) and had no impact on mortality result ing from heart failure or noncardiac causes . The cardiac and tachyarrhythmia mortality reductions were evident in subjects with New York Heart Association class II but not in subjects with class III heart failure . The reduction in tachyarrhythmia mortality with ICD therapy was similar in subjects with ischemic and nonischemic disease . Compared with placebo , amiodarone had no significant effect on any mode of death . Conclusions — ICD therapy reduced cardiac mortality and sudden death presumed to be ventricular tachyarrhythmic in SCD-HeFT and had no effect on heart failure mortality . Amiodarone had no effect on all-cause mortality or its cause-specific components , except an increase in non-cardiac mortality in class III patients . Clinical Trial Registration Information— URL : http://www . clinical trials.gov . Unique identifier : NCT00000609 The number needed to treat ( NNT ) is a simple measure of a treatment 's impact , increasingly reported in r and omized trials and observational studies . Its calculation in studies involving varying follow-up times or recurrent outcomes has been criticized . We discuss the NNT in these context s , illustrating using several published studies . The computation of the NNT is founded on the cumulative incidence of the outcome . Instead , several published studies use simple proportions that do not account for varying follow-up times , or use incidence rates per person-time . We show that these approaches can lead to erroneous values of the NNT and misleading interpretations . For example , after converting the incidence rate to a cumulative incidence , we show that a trial reporting a NNT of 4 " to prevent one exacerbation in 1 year " should have reported a NNT of 9 . A survey of all papers reporting NNT , published in four major medical journals in 2009 , found that 6 out of all 10 papers involving varying follow-up times did not correctly estimate the NNT . As the " number needed to treat " becomes increasingly used in complex studies and in the comparative effectiveness of therapies , its accurate estimation and interpretation become crucial to avoid erroneous clinical and public health decisions Objective : To compare the effects of cardiac resynchronisation therapy ( CRT ) in patients with heart failure ( HF ) in either atrial fibrillation ( AF ) or sinus rhythm ( SR ) . Design : Prospect i ve observational study . Patients : 295 consecutive patients with HF ( permanent AF in 66 , paroxysmal AF in 20 , SR in 209 ; New York Heart Association ( NYHA ) class III or IV ; left ventricular ejection fraction ( LVEF ) ⩽35 % , QRS ⩾120 ms ) . Interventions : All patients underwent CRT without atrioventricular junction ablation . Main outcome measures : The primary end point was the composite of cardiovascular death or unplanned hospitalisation for major cardiovascular events . Secondary end points included the composite of cardiovascular death or hospitalisation for worsening HF . Cardiovascular mortality , total mortality and changes in NYHA class , 6-minute walking distance , quality of life ( Minnesota Living with Heart Failure question naire ) and echocardiographic variables were also considered . Results : Over a follow-up period of up to 6.8 years , no differences emerged between patients in AF or SR in any of the mortality or morbidity end points . The AF and SR groups derived similar improvements in mean NYHA class ( −1.3 vs –1.2 ) , 6-minute walking distance ( 92.3 vs 78.4 m ) and quality of life scores ( −25.2 vs –18.7 ) ( all p<0.001 ) . In both the AF and the SR groups , reductions were seen in left ventricular end-systolic ( −25.9 vs –34.5 ml , both p<0.001 ) and end-diastolic ( −20.2 ml , p = 0.001 vs 26.2 ml , p<0.001 ) volumes and improvements in LVEF ( 4.69 % vs 7.86 % , both p<0.001 ) . Conclusions : Cardiac resynchronisation therapy leads to similar prognostic and symptomatic benefits in patients in AF and SR , even without atrioventricular junction ablation . Echocardiographic improvements are also comparable Background —Cardiac resynchronization therapy ( CRT ) decreases mortality , improves functional status , and induces reverse left ventricular remodeling in selected population s with heart failure . These benefits have been noted with both CRT-pacemakers as well as those devices with defibrillator backup ( CRT-D ) . However , there are little data comparing mortality between these 2 device types . Methods and Results —REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction ( REVERSE ) was a multicenter , r and omized trial of CRT among patients with mild heart failure . Long-term annual follow-up for 5 years was preplanned . The present analysis was confined to the 419 patients who were r and omized to active CRT group . CRT-pacemakers or CRT-D devices were implanted based on national guidelines at the time of enrollment , with 74 patients receiving CRT pacemaker devices and the remaining 345 patients receiving CRT-D devices . After 12 months of CRT , changes in the clinical composite score , left ventricular end systolic volume index , 6-minute walk time , and quality of life indices were similar between CRT pacemaker and CRT-D patients . However , long-term follow-up showed lower morality in the CRT-D group . Specifically , multivariable analysis showed that CRT-D ( hazard ratio , 0.35 ; P=0.003 ) was a strong independent predictor of survival . Female sex , longer unpaced QRS duration , and smaller baseline left ventricular end systolic volume index also were also associated with better survival . Conclusions —REVERSE demonstrated that the addition of implantable cardioverter-defibrillator therapy to CRT is associated with improved long-term survival compared with CRT pacing alone in mild heart failure . Clinical Trial Registration —URL : http:// clinical trials.gov . Unique Identifier : NCT00271154 AIMS The CArdiac REsynchronization-Heart Failure study r and omized patients with left ventricular ejection fraction < or = 35 % , markers of cardiac dyssynchrony , and persistent moderate or severe symptoms of heart failure despite pharmacological therapy , to implantation of a cardiac resynchronization therapy ( CRT ) device or not . The main study observed substantial benefits on morbidity and mortality during a mean follow-up of 29.4 months [ median 29.6 , interquartile range ( IQR ) 23.6 - 34.6 ] . Prior to study closure , an extension phase lasting a further 8 months ( allowing time for data analysis and presentation ) was declared during which cross-over was discouraged . METHODS AND RESULTS This was an extension of the already reported open-label r and omized trial described above . The primary outcome of the extension phase was all-cause mortality from the time of r and omization to completion of the extension phase . The secondary outcome was mode of death . The mean follow-up was 37.4 months ( median 37.6 , IQR 31.5 - 42.5 , range 26.1 - 52.6 months ) . There were 154 deaths ( 38.1 % ) in 404 patients assigned to medical therapy and 101 deaths ( 24.7 % ) in 409 patients assigned to CRT ( hazard ratio 0.60 , 95 % CI 0.47 - 0.77 , P<0.0001 ) without evidence of heterogeneity in pre-specified subgroups . A reduction in the risk of death due to heart failure ( 64 vs. 38 deaths ; hazard ratio 0.55 , 95 % CI 0.37 - 0.82 , P=0.003 ) and sudden death was observed ( 55 vs. 32 ; hazard ratio 0.54 , 95 % CI 0.35 - 0.84 , P=0.005 ) . CONCLUSION The benefits of CRT observed in the main trial persist or increase with longer follow-up . Reduction in mortality was due to fewer deaths both from worsening heart failure and from sudden death
Output:
| The extent of SCD in CRT-P patients significantly increased in studies with higher percentage of males , ischaemic cardiomyopathy and NYHA class 3 .
Conclusion Overall , compared with CRT-D patients , unadjusted mortality rate was almost two-fold higher in CRT-P recipients , with SCD representing one third of the excess mortality .
Rate of SCD was significantly higher in certain subgroups ( males , ischaemic cardiomyopathy , NYHA class 3 ) , where a CRT-D may be of more pronounced benefit . |
MS212930 | ***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 Our aim was to assess cost-effectiveness of mindfulness-based cognitive therapy ( MBCT ) compared with enhanced usual care ( EUC ) in treating patients with persistent medically unexplained symptoms(MUS ) . METHODS A full economic evaluation with a one year time horizon was performed from a societal perspective . Costs were assessed by prospect i ve cost diaries . Health-related Quality of Life was measured using SF-6D . Outcomes were costs per Quality -Adjusted Life Year ( QALY ) . Bootstrap simulations were performed to obtain mean costs , QALY scores and incremental cost-effectiveness ratios ( ICERs ) . RESULTS MBCT participants ( n=55 ) had lower hospital costs and higher mental health care costs than patients who received EUC ( n=41 ) . Mean bootstrapped costs for MBCT were € 6269 , and € 5617 for EUC ( 95 % uncertainty interval for difference : -€1576 ; € 2955 ) . QALYs were 0.674 for MBCT and 0.663 for EUC . MBCT was on average more effective and more costly than EUC , result ing in an ICER of € 56,637 per QALY gained . At a willingness to pay of € 80,000 per QALY , the probability that MBCT is cost-effective is 57 % . CONCLUSION Total costs were not statistically significantly different between MBCT and EUC . However , MBCT seemed to cause a shift in the use of health care re sources as mental health care costs were higher and hospital care costs lower in the MBCT condition . Due to the higher drop-out in the EUC condition the cost-effectiveness of MBCT might have been underestimated . The shift in health care use might lead to more effective care for patients with persistent MUS . The longer-term impact of MBCT for patients with persistent MUS needs to be further studied Summary Background Depression is a common , debilitating , and costly disorder . Many patients request psychological therapy , but the best- evidence d therapy — cognitive behavioural therapy (CBT)—is complex and costly . A simpler therapy — behavioural activation (BA)—might be as effective and cheaper than is CBT . We aim ed to establish the clinical efficacy and cost-effectiveness of BA compared with CBT for adults with depression . Methods In this r and omised , controlled , non-inferiority trial , we recruited adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder from primary care and psychological therapy services in Devon , Durham , and Leeds ( UK ) . We excluded people who were receiving psychological therapy , were alcohol or drug dependent , were acutely suicidal or had attempted suicide in the previous 2 months , or were cognitively impaired , or who had bipolar disorder or psychosis or psychotic symptoms . We r and omly assigned participants ( 1:1 ) remotely using computer-generated allocation ( minimisation used ; stratified by depression severity [ Patient Health Question naire 9 ( PHQ-9 ) score of < 19 vs ≥19 ] , antidepressant use , and recruitment site ) to BA from junior mental health workers or CBT from psychological therapists . R and omisation done at the Peninsula Clinical Trials Unit was concealed from investigators . Treatment was given open label , but outcome assessors were masked . The primary outcome was depression symptoms according to the PHQ-9 at 12 months . We analysed all those who were r and omly allocated and had complete data ( modified intention to treat [ mITT ] ) and also all those who were r and omly allocated , had complete data , and received at least eight treatment sessions ( per protocol [ PP ] ) . We analysed safety in the mITT population . The non-inferiority margin was 1·9 PHQ-9 points . This trial is registered with the ISCRTN registry , number IS RCT N27473954 . Findings Between Sept 26 , 2012 , and April 3 , 2014 , we r and omly allocated 221 ( 50 % ) participants to BA and 219 ( 50 % ) to CBT . 175 ( 79 % ) participants were assessable for the primary outcome in the mITT population in the BA group compared with 189 ( 86 % ) in the CBT group , whereas 135 ( 61 % ) were assessable in the PP population in the BA group compared with 151 ( 69 % ) in the CBT group . BA was non-inferior to CBT ( mITT : CBT 8·4 PHQ-9 points [ SD 7·5 ] , BA 8·4 PHQ-9 points [ 7·0 ] , mean difference 0·1 PHQ-9 points [ 95 % CI −1·3 to 1·5 ] , p=0·89 ; PP : CBT 7·9 PHQ-9 points [ 7·3 ] ; BA 7·8 [ 6·5 ] , mean difference 0·0 PHQ-9 points [ –1·5 to 1·6 ] , p=0·99 ) . Two ( 1 % ) non-trial-related deaths ( one [ 1 % ] multidrug toxicity in the BA group and one [ 1 % ] cancer in the CBT group ) and 15 depression-related , but not treatment-related , serious adverse events ( three in the BA group and 12 in the CBT group ) occurred in three [ 2 % ] participants in the BA group ( two [ 1 % ] patients who overdosed and one [ 1 % ] who self-harmed ) and eight ( 4 % ) participants in the CBT group ( seven [ 4 % ] who overdosed and one [ 1 % ] who self-harmed ) . Interpretation We found that BA , a simpler psychological treatment than CBT , can be delivered by junior mental health workers with less intensive and costly training , with no lesser effect than CBT . Effective psychological therapy for depression can be delivered without the need for costly and highly trained professionals . Funding National Institute for Health Research The aim of this study was to analyze the cost utility of a group-based form of acceptance and commitment therapy ( GACT ) in patients with fibromyalgia ( FM ) compared with patients receiving recommended pharmacological treatment ( RPT ) or on a waiting list ( WL ) . The data were derived from a previously published study , a r and omized controlled trial that focused on clinical outcomes . Health economic outcomes included health-related quality of life and health care use at baseline and at 6-month follow-up using the EuroQoL and the Client Service Receipt Inventory , respectively . Analyses included quality -adjusted life years , direct and indirect cost differences , and incremental cost effectiveness ratios . A total of 156 FM patients were r and omized ( 51 GACT , 52 RPT , 53 WL ) . GACT was related to significantly less direct costs over the 6-month study period compared with both control arms ( GACT € 824.2 ± 1,062.7 vs RPT € 1,730.7 ± 1,656.8 vs WL € 2,462.7 ± 2,822.0 ) . Lower direct costs for GACT compared with RPT were due to lower costs from primary care visits and FM-related medications . The incremental cost effectiveness ratios were dominant in the completers ' analysis and remained robust in the sensitivity analyses . In conclusion , acceptance and commitment therapy appears to be a cost-effective treatment compared with RPT in patients with FM . PERSPECTIVE Decision-makers have to prioritize their budget on the treatment option that is the most cost effective for the management of a specific patient group . From government as well as health care perspectives , this study shows that a GACT is more cost effective than pharmacological treatment in management of FM Objective To explore participant views on acceptability , mechanisms of change and impact of behavioural activation ( BA ) delivered by junior mental health workers ( MHWs ) versus cognitive behavioural therapy ( CBT ) delivered by professional psychotherapists . Design Semistructured qualitative interviews analysed using a framework approach . Participants 36 participants with major depressive disorder purposively sample d from a r and omised controlled trial of BA versus CBT ( the COBRA trial ) . Setting Primary care psychological therapies services in Devon , Durham and Leeds , UK . Results Elements of therapy considered to be beneficial included its length and regularity , the opportunity to learn and not dwelling on the past . Homework was an important , although challenging aspect of treatment . Therapists were perceived as experts who played an important role in treatment . For some participants the most important element of therapy was having someone to talk to , but for others the specific factors associated with BA and CBT were crucial , with behavioural change considered important for participants in both treatments , and cognitive change unsurprisingly discussed more by those receiving CBT . Both therapies were considered to have a positive impact on symptoms of depression and other areas of life including feelings about themselves , self-care , work and relationships . Barriers to therapy included work , family life and emotional challenges . A subset ( n=2 ) of BA participants commented that therapy felt too simple , and MHWs could be perceived as inexperienced . Many participants saw therapy as a learning experience , providing them with tools to take away , with work on relapse prevention essential . Conclusions Despite barriers for some participants , BA and CBT were perceived to have many benefits , to have brought about cognitive and behavioural change and to produce improvements in many domains of participants ’ lives . To optimise the delivery of BA , inexperienced junior MHWs should be supported through good quality training and ongoing supervision . Trial registration number IS RCT N27473954 , Background : A primary goal of dialectical behaviour therapy ( DBT ) is to reduce self-harm , but findings from empirical studies are inconclusive . The aim of this study was to assess the effectiveness and cost-effectiveness of DBT in reducing self-harm in patients with personality disorder . Methods : Participants with a personality disorder and at least 5 days of self-harm in the previous year were r and omised to receive 12 months of either DBT or treatment as usual ( TAU ) . The primary outcome was the frequency of days with self-harm ; secondary outcomes included borderline personality disorder symptoms , general psychiatric symptoms , subjective quality of life , and costs of care . Results : Forty patients each were r and omised to DBT and TAU . In an intention-to-treat analysis , there was a statistically significant treatment by time interaction for self-harm ( incidence rate ratio 0.91 , 95 % CI 0.89–0.92 , p < 0.001 ) . For every 2 months spent in DBT , the risk of self-harm decreased by 9 % relative to TAU . There was no evidence of differences on any secondary outcomes . The economic analysis revealed a total cost of a mean of 5,685 GBP ( 6,786 EUR ) in DBT compared to a mean of 3,754 GBP ( 4,481 EUR ) in TAU , but the difference was not significant ( 95 % CI –603 to 4,599 GBP ) . Forty-eight per cent of patients completed DBT . They had a greater reduction in self-harm compared to dropouts ( incidence rate ratio 0.78 , 95 % CI 0.76–0.80 , p < 0.001 ) . Conclusions : DBT can be effective in reducing self-harm in patients with personality disorder , possibly incurring higher total treatment costs . The effect is stronger in those who complete treatment . Future research should explore how to improve treatment adherence A general approach is discussed to assess the uncertainty surrounding the cost effectiveness ratio ( C/E-ratio ) estimated on the basis of data from a r and omised clinical trial . The approach includes the calculation of a 95 % probability ellipse and introduces the concept of a so called C/E-acceptability curve . This last curve defines for each predefined C/E-ratio the probability that the C/E-ratio found in the study is acceptable . The approach is illustrated by estimates of costs per life saved and costs per patient discharged alive on the basis of data from a phase II trial addressing the value of anakinra in treating sepsis syndrome Ost ( 2008 ) recently compared the method ological rigor of studies of acceptance and commitment therapy ( ACT ) and traditional cognitive behavior therapy ( CBT ) . He concluded that the ACT studies had more method ological deficiencies , and thus the treatment did not qualify as an " empirically supported treatment . " Although Ost noted several important limitations that should be carefully considered when evaluating early ACT research , his attempt to devise an empirical matching strategy by creating a comparison sample of CBT studies to bolster his conclusions was itself problematic . The sample s were clearly mismatched in terms of the population s being treated , leading to differences in study design and methodology . Furthermore , re analysis showed clear differences in grant support favoring CBT compared with ACT studies that were not reported in the original article . Given the actual mismatch between the sample s , Ost 's method ological ratings are difficult to interpret and provide little useful information beyond what could already be gathered by a qualitative review of ACT study limitations . Such limitations are characteristic of the earlier r and omized controlled trials of any emerging psychotherapeutic approach Background : Mindfulness-based interventions have been shown to effectively reduce anxiety , depression and pain in patients with chronic physical illnesses . Objectives : We assessed the potential effectiveness and cost-effectiveness of a specially adapted Skype distant-delivered mindfulness intervention , design ed to reduce distress for people affected by primary and secondary progressive MS . Methods Forty participants were r and omly assigned to the eight-week intervention ( n = 19 ) or a waiting-list control group ( n = 21 ) . Participants completed st and ardised question naires to measure mood , impact of MS and symptom severity , quality of life and service costs at baseline , post-intervention and three-month follow-up
Output:
| Mindfulness-Based Cognitive Therapy ( MBCT ) , Mindfulness-Based Stress Reduction ( MBSR ) , Acceptance and Commitment Therapy ( ACT ) , Dialectical Behavior Therapy ( DBT ) , and extended Behaviour Activation ( eBA ) showed acceptable cost-effectiveness and cost-utility ratios .
There is some evidence that MBCT , MBSR , ACT , DBT , and eBA are efficient from a societal or a third-party payer perspective .
No economic analysis was found for many third-wave therapies . |
MS212931 | ***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 The study objective was to compare the 30-day outcomes of a st and ardized aortic valve repair technique ( REPAIR group ) associating root remodeling with an expansible aortic ring annuloplasty versus mechanical composite valve and graft ( CVG group ) replacement in treating aortic root aneurysms . METHODS A total of 261 consecutive patients with aortic root aneurysm were enrolled in this multicentric prospect i ve cohort ( 131 in the CVG group , 130 in the REPAIR group ) in 20 centers . The main end point is a composite criterion including mortality ; reoperation ; thromboembolic , hemorrhagic , or infectious events ; and heart failure . Secondary end points were major adverse valve-related events . Crude and propensity score adjusted estimates are provided . RESULTS The mean age was 56.1 years , and the valve was bicuspid in 115 patients ( 44.7 % ) . The median ( interquartile range ) preoperative aortic insufficiency grade was 2.0 ( 1.0 - 3.0 ) in the REPAIR group and 3.0 ( 2.0 - 3.0 ) in the CVG group ( P = .0002 ) . Thirty-day mortality was 3.8 % ( n = 5 ) in both groups ( P = 1.00 ) . Despite a learning curve and longer crossclamp times for valve repair ( 147.7 vs 99.8 minutes , P < .0001 ) , the 2 groups did not differ significantly for the main criterion ( odds ratio , 1.31 ; 95 % confidence interval , 0.72 - 2.40 ; P = .38 ) or 30-day mortality ( odds ratio , 0.99 ; 95 % confidence interval , 0.28 - 3053 ; P = .99 ) , with a trend toward more frequent major adverse valve-related events in the CVG group ( odds ratio , 2.52 ; 95 % confidence interval , 0.86 - 7.40 ; P = .09 ) . At discharge , 121 patients ( 96.8 % ) in the REPAIR group had grade 0 or 1 aortic insufficiency . CONCLUSIONS A new st and ardized approach to valve repair , combining an expansible aortic annuloplasty ring with the remodeling technique , presented similar 30-day results to mechanical CVG with a trend toward reducing major adverse valve-related events . Analysis of late outcomes is in process for 3- and 10-year follow-ups BACKGROUND Refining leaflet reconstruction has become a primary issue in aortic valve repair . This descriptive analysis review s leaflet pathology , repair techniques , and early results in a prospect i ve regulatory trial of aortic valve repair . METHODS Sixty-five patients underwent valve repair for predominant moderate to severe aortic insufficiency ( AI ) . The mean age was 63 ± 13 years , and 69 % of the patients were male . Ascending aortic/root replacement was required in 62 % . As a first step , ring annuloplasty was performed , and then leaflet repair included leaflet plication for prolapse , nodular unfolding , double pericardial patching of commissural defects or holes , complete pericardial leaflet replacement , leaflet extension , and Gore-Tex reinforcement . Leaflet techniques and causes of adverse outcomes were evaluated . RESULTS The follow-up time was 2-years maximal and 0.9 years mean , with a survival of 97 % . Eighty percent of patients required repair of leaflet defects : leaflet prolapse ( 52/65 - 80 % ) , ruptured commissures ( 6/65 - 9 % ) , leaflet holes ( 4/65 - 6 % ) , and nodular retraction ( 6/65 - 9 % ) . The average preoperative AI grade of 2.9 ± 0.8 fell to 0.7 ± 0.7 ( p < 0.0001 ) . Three patients ( 4.6 % ) required interval valve replacement because of ( 1 ) suture untying , ( 2 ) iatrogenic leaflet tear , or ( 3 ) diphtheroid endocarditis . Five other patients experienced grade 2 or grade 3 AI : probable suture untying in 1 patient , ineffective leaflet extensions in 2 patients , and unsuccessful Gore-Tex reinforcements in 2 patients . Two patients with single pericardial leaflet replacements and all those with double pericardial reconstructions did well . CONCLUSIONS Leaflet defects are common in patients with moderate to severe AI . Leaflet plication , nodular unfolding , and double pericardial patching performed well . Gore-Tex and leaflet extension seemed less satisfactory . St and ardization and experience with leaflet reconstruction will be important for optimizing the outcomes of aortic valve repair Comprehensive aortic root and valve repair ( CARVAR ) is a recently introduced surgical technique for aortic valve disease . The National Evidence -based Health Care Collaborating Agency was offered by the ministry of Health and Welfare , Korea to perform a restrospective outcome analysis for this surgical procedure . The aims of this study were to evaluate the safety of patients who underwent CARVAR surgery and to provide a rationale for further prospect i ve r and omized study . During the period of March 2007 to November 2009 , 397 patients received this procedure and enrolled in this study . Clinical events including major bleeding , endocarditis , re-operation and death were followed-up till March 2010 by medical records . During the follow-up periods , 1-year cumulative incidence of major bleeding , re-operation , endocarditis and death were 3.55 , 5.65 , 5.05 and 5.33%/year respectively . This study showed that the CARVAR technique is not beneficial , and is indeed even more harmful than conventional valve replacement surgery OBJECTIVES A geometric annuloplasty ring could improve efficacy and stability of aortic valve repair . Toward this goal , a 1-piece 3-dimensional titanium annuloplasty ring with Dacron covering was developed and tested successfully in animals . The purpose of this study was to define hemodynamic outcomes with this device used as the annuloplasty component of human aortic valve repair . METHODS In a 4-center pilot trial with informed consent , 16 patients underwent aortic valve repair for aortic insufficiency , with the annuloplasty device sutured into the annulus beneath the leaflets . Preoperative annular diameter averaged 26.5 ± 2.0 ( mean ± st and ard deviation ) mm , and average ring size was 22.3 ± 1.2 mm . After annuloplasty , leaflet defects were easy to identify , and 14 of 16 patients ( 88 % ) required leaflet plication and /or autologous pericardial reconstruction for leaflet defects . Three patients had ascending aortic replacement , and 2 had remodeling root replacement . One had ultrasonic leaflet decalcification and another tricuspid valve annuloplasty . Follow-up data were from site-specific studies at the 6-month postoperative time point . RESULTS There were no in-hospital mortalities or major complications . Preoperative aortic insufficiency grade ( 0 - 4 scale ) was 3.6 ± 1.0 and fell to 1.0 ± 0.8 at 6 months ( P < .0001 ) . New York Heart Association class fell from 2.5 ± 0.5 to 1.1 ± 0.3 ( P < .0001 ) . Postrepair valve area was 2.7 ± 0.2 cm(2 ) , and 6-month mean systolic gradient was 11.3 ± 3.3 mm Hg . Left ventricular end-diastolic diameter and ejection fraction both normalized ( both P < .0001 ) . CONCLUSIONS Geometric ring annuloplasty facilitated aortic valve repair , allowing more precise reconstruction of leaflet defects . Aortic insufficiency reduction and systolic gradients were excellent , and expansion of valve reconstruction into broader categories of aortic valve disease seems indicated
Output:
| Their clinical outcomes seem currently acceptable in general , and external flexible annuloplasty has been performed more frequently with favorable outcomes .
However , they are still performed for a minority of patients by special experienced teams with limited follow-up periods . |
MS212932 | ***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: With the increasing use of magnetic resonance imaging ( MRI ) , the physician is more frequently confronted with nonpalpable breast lesions that are only visible on MRI . In these cases , it is often difficult to obtain adequate material for pathological examination . One of the methods that may be performed is excisional biopsy after MRI-guided wire localization . This study intends to examine the feasibility and added benefit of this method . It appears to be a reliable and useful tool that is , therefore , of additional benefit to surgical practice Background Few published studies have shown the benefits of intraoperative ultrasound in avoiding inadequate margins in breast-conserving surgery . The aim of this study is to quantify intraoperative ultrasound margin size and assess its relationship to tumor size , multifocality , palpability , histology , and presence of intraductal component . Methods Patients with breast cancer undergoing breast-conserving surgery in whom the operating surgeon visualized the tumor by ultrasound were included . Ultrasound margins measured intraoperatively were prospect ively recorded and compared with pathology margins . Results Forty-five patients with 48 tumors were included . Twenty five patients ( 56 % ) had palpable tumors . Pathologic mean tumor size was 1.9 cm [ 95 % confidence interval ( CI ) 1.6–2.2 cm , range 0.5–4.8 cm ] . There was good correlation between closest margins recorded by ultrasound and pathology margins ( r = 0.4674 , P < 0.0008 ) . Fourteen patients ( 31 % ) had margins re-excised intraoperatively , 12 of them in the direction of the closest pathological margin . Three patients ( 7 % ) , all of whom had intraoperative re-excision , had a second operation for involved margins without residual cancer on pathological examination of the reoperative specimens . Ultrasound margins ≥0.5 cm achieved adequate pathology margins of ≥0.2 cm in 95 % of margins . Overestimation of pathology margins by ultrasound measurement was significantly affected by multifocality ( P = 0.0473 ) . Tumor size , palpability , invasive lobular histology , and presence of ductal carcinoma in situ ( DCIS ) did not cause significant overestimation of pathology margins by ultrasound . Conclusions Intraoperative ultrasound may help maintain a low level of reoperation after breast-conserving surgery . Ultrasound margins < 0.5 cm should be re-excised intraoperatively . Reliability of ultrasound in predicting the closest pathology margins was diminished in patients with multifocal tumors Abstract Background : Wire localization ( WL ) is the current st and ard for surgical diagnosis of nonpalpable breast lesions . Many disadvantages inherent to WL are solved with radioactive seed localization ( RSL ) . This trial investigated the ability of RSL to reduce the need for specimen radiographs and operating room delays associated with WL . Methods : A total of 134 women were entered onto an institutional review board – approved study . RSL was performed by placing a titanium seed containing .29 to 20 mCi of iodine-125 to within 1 cm of the suggestive breast lesion . The surgeon used a h and held gamma detector to locate and excise the iodine-125 seed and the lesion . Results : Specimen radiographs were eliminated in 98 ( 79 % ) of 124 patients . Surgical seed retrieval was 100 % in 124 patients . No seed migration occurred after correct radiographical placement . A total of 26 ( 21 % ) of 124 patients required a specimen radiograph ; 22 ( 85 % ) of these 26 were performed for microcalcifications . Conclusions : After surgical removal , RSL can eliminate specimen radiographs when the radiologist accurately places the seed and the pathologist grossly identifies the lesion . If small microcalcifications are noted before surgery , then specimen radiographs may be necessary . RSL reduced requirements for specimen radiographs , decreased OR time , improved incision placement , and improved resections to clear margins Background The wire-guided excision of nonpalpable breast cancer often results in tumor resections with inadequate margins . This prospect i ve , r and omized trial was undertaken to investigate whether intraoperative ultrasound ( US ) guidance enables a better margin clearance than the wire-guided technique in the breast-conserving treatment of nonpalpable breast cancers . Methods Patients with a preoperative histological diagnosis of nonpalpable breast cancer that could be visualized both with US and mammography were included . Patients were r and omized to undergo either a wire-guided or a US-guided excision . Adequate margins were defined as ≥1 mm . Results Of 49 included patients , 23 were assigned to undergo wire-guided excision and 26 to undergo US-guided excision . One patient crossed over to US-guided excision after inadvertent wire displacement . Mean tumor diameter , specimen weight , and operating time were similar in both groups . The excision was adequate in 24 ( 89 % ) of 27 US-guided excisions and 12 ( 55 % ) of 22 wire-guide excisions ( P=.007 ) . Conclusions US-guided excision seems to be superior to wire-guided excision with respect to margin clearance of mammographically detected and US-visible nonpalpable breast cancers . Patients do not have to undergo the unpleasant wire placement before surgery BACKGROUND Routine resection of cavity shave margins ( additional tissue circumferentially around the cavity left by partial mastectomy ) may reduce the rates of positive margins ( margins positive for tumor ) and reexcision among patients undergoing partial mastectomy for breast cancer . METHODS In this r and omized , controlled trial , we assigned , in a 1:1 ratio , 235 patients with breast cancer of stage 0 to III who were undergoing partial mastectomy , with or without resection of selective margins , to have further cavity shave margins resected ( shave group ) or not to have further cavity shave margins resected ( no-shave group ) . R and omization occurred intraoperatively after surgeons had completed st and ard partial mastectomy . Positive margins were defined as tumor touching the edge of the specimen that was removed in the case of invasive cancer and tumor that was within 1 mm of the edge of the specimen removed in the case of ductal carcinoma in situ . The rate of positive margins was the primary outcome measure ; secondary outcome measures included cosmesis and the volume of tissue resected . RESULTS The median age of the patients was 61 years ( range , 33 to 94 ) . On final pathological testing , 54 patients ( 23 % ) had invasive cancer , 45 ( 19 % ) had ductal carcinoma in situ , and 125 ( 53 % ) had both ; 11 patients had no further disease . The median size of the tumor in the greatest diameter was 1.1 cm ( range , 0 to 6.5 ) in patients with invasive carcinoma and 1.0 cm ( range , 0 to 9.3 ) in patients with ductal carcinoma in situ . Groups were well matched at baseline with respect to demographic and clinicopathological characteristics . The rate of positive margins after partial mastectomy ( before r and omization ) was similar in the shave group and the no-shave group ( 36 % and 34 % , respectively ; P=0.69 ) . After r and omization , patients in the shave group had a significantly lower rate of positive margins than did those in the no-shave group ( 19 % vs. 34 % , P=0.01 ) , as well as a lower rate of second surgery for margin clearance ( 10 % vs. 21 % , P=0.02 ) . There was no significant difference in complications between the two groups . CONCLUSIONS Cavity shaving halved the rates of positive margins and reexcision among patients with partial mastectomy . ( Funded by the Yale Cancer Center ; Clinical Trials.gov number , NCT01452399 . ) The role of cavity shaves in reducing re-excision rates in breast conserving surgery ( BCS ) remains unclear . We compared rates of close margins and re-excision following cavity shaves based on either intraoperative radiology or systematic cavity shaves . Data was recorded prospect ively from 1999 to 2003 for 217 patients undergoing BCS . For the first 106 cases , cavity shaves were performed when intraoperative radiological margins appeared close ( < 10 mm ) . The remaining 111 cases had systematic superior and inferior cavity shaves ( SSICS ) . Close margins and re-excision rates were compared between groups . The median weight of excised tissue was less in group two : 82.8 g versus 100.5 g , P=0.001 . SSICS reduced close margins by 83 % ( 18/106 versus 8/111 ) , OR 0.17 , 95 % CI 0.08 - 0.48 , P=0.001 . Multivariate analysis showed SSICS also reduced re-excision rates ( 15 versus 8 cases ) , OR 0.26 , 95 % CI 0.09 - 0.74 , P=0.012 . SSICS reduces close margins and re-excision rates . This approach has additional cosmetic benefits because less tissue is excised Background Studies suggest radioguided seed localization ( RSL ) yields fewer positive margins than wire-guided localization ( WL ) . The goal of this study is to determine whether RSL is superior to WL . Methods Women with confirmed invasive or ductal carcinoma in situ ( DCIS ) undergoing localization and breast conserving surgery were enrolled . Outcomes measured include positive margin and reoperation rates , specimen weight , operative and localization times , and surgeon and radiologist ranking of procedural difficulty . Results R and omization was central ized , concealed , and stratified by surgeon with 153 patients in the WL group and 152 in RSL group . Localizations were performed using either ultrasound ( 70 % ) or mammographic guidance ( 30 % ) . Pathology was either DCIS ( 18 % ) or invasive carcinoma ( 82 % ) . Procedures were performed at 3 sites , by 7 surgeons . Only difference found for patient and tumor characteristics was more multifocal disease in RSL group . Using intention-to-treat analysis , there were no differences in positive margins rates for RSL ( 10.5 % ) and WL ( 11.8 % ) , ( P = .99 ) or for positive or close margins ( < 1 mm ) ( RSL 19 % and WL 22 % ; P = .61 ) . Mean operative time ( minutes ) was shorter for RSL ( RSL 19.4 vs WL 22.2 ; P < .001 ) . Specimen volume , weight , reoperation and localization times were similar . Surgeons ranked the seed technique as easier ( P = .008 ) , while radiologists ranked them similarly . Patient ’s pain rankings during wire localization were higher ( P = .038 ) . Conclusions In contrast to other trials positive margin and reoperation rates were similar for RSL and WL . However , for RSL operative times were shorter , and the technique was preferred by surgeons , making it an acceptable method for localization Objective : To develop an intraoperative method for margin status evaluation during breast conservation therapy ( BCT ) using an automated analysis of imprint cytology specimens . Study Design : Imprint cytology sample s were prospect ively taken from 47 patients undergoing either BCT or breast reduction surgery . Touch preparations from BCT patients were taken on cut sections through the tumor to generate positive margin controls . For breast reduction patients , slide imprints were taken at cuts through the center of excised tissue . Analysis results from the presented technique were compared against st and ard pathologic diagnosis . Slides were stained with cytokeratin and Hoechst , imaged with an automated fluorescent microscope , and analyzed with a fast algorithm to automate discrimination between epithelial cells and noncellular debris . Results : The accuracy of the automated analysis was 95 % for identifying invasive cancers compared against final pathologic diagnosis . The overall sensitivity was 87 % while specificity was 100 % ( no false positives ) . This is comparable to the best reported results from manual examination of intraoperative imprint cytology slides while reducing the need for direct input from a cytopathologist . Conclusion : This work demonstrates a proof of concept for developing a highly accurate and automated system for the intraoperative evaluation of margin status to guide surgical decisions and lower positive margin rates Lumpectomy specimens are commonly divided into six sides : superficial , deep , superior , inferior , medial , and lateral . Orienting stitches are placed on the specimen during surgery to allow reorientation by pathology . Despite those efforts , specimen disorientation may occur . The aim of this study was to assess the correlation in orientation between surgeons and pathologists . Lumpectomy specimens were routinely oriented . An additional Prolene suture was r and omly placed by the surgeon on one side to be localized by pathology . The results were recorded and the disorientation rate calculated . Specimen size and presence of skin and /or muscle were also recorded . There were 122 lumpectomy specimens prospect ively entered . Average specimen volume was 95.5 cm3 . Twenty-four specimens had segments of skin or muscle . The additional sutures were evenly divided between the six sides . The overall disorientation rate was 31.1 % ( 95 % confidence interval , 23.1–40.2).The side-specific disorientation rates were 43 % , 40 % , 35 % , 29 % , 28 % , and 14 %
Output:
| Conclusions A practical approach to performance improvement was used by the American Society of Breast Surgeons to create a toolbox of options to reduce lumpectomy reoperations and improve cosmetic outcomes |
MS212933 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background A commonly reported problem with the conduct of multicentre r and omised controlled trials ( RCTs ) is that recruitment is often slower or more difficult than expected , with many trials failing to reach their planned sample size within the timescale and funding originally envisaged . The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies : the UK Medical Research Council ( MRC ) and the Health Technology Assessment ( HTA ) Programme . Methods The cohort of trials was identified from the administrative data bases held by the two funding bodies . 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria . The full scientific applications and subsequent trial reports su bmi tted by the trial teams to the funders provided the principal data sources . Associations between trial characteristics and recruitment success were tested using the Chi-squared test , or Fisher 's exact test where appropriate . Results Less than a third ( 31 % ) of the trials achieved their original recruitment target and half ( 53 % ) were awarded an extension . The proportion achieving targets did not appear to improve over time . The overall start to recruitment was delayed in 47 ( 41 % ) trials and early recruitment problems were identified in 77 ( 63 % ) trials . The inter-relationship between trial features and recruitment success was complex . A variety of strategies were employed to try to increase recruitment , but their success could not be assessed . Conclusion Recruitment problems are complex and challenging . Many of the trials in the cohort experienced recruitment difficulties . Trials often required extended recruitment periods ( sometimes supported by additional funds ) . While this is of continuing concern , success in addressing the trial question may be more important than recruitment alone This paper reports findings on parental engagement in a community-based parent training intervention . As part of a r and omized trial , 821 parents were offered group-based Triple P as a parenting skills prevention program . Program implementation was conducted by practitioners . The intervention was implemented between Waves 1 and 2 of a longitudinal study , with a participation rate of 69 % and a retention rate of 96 % . The study finds that a practitioner-led dissemination can achieve recruitment and completion rates that are similar to those reported in research er-led trials . Second , the study found that different factors are associated with the various stages of the parental engagement process . Family-related organizational and timing obstacles to participation primarily influence the initial stages of parental involvement . The strength of neighborhood networks plays a considerable role at the participation and completion stages of parental engagement . The general course climate and the intensity of program exposure predict the utilization of the program several months after the delivery Background As the number of r and omised controlled trials of medicines for children increases , it becomes progressively more important to underst and the experiences of parents who are asked to enrol their child in a trial . This paper presents a narrative review of research evidence on parents ' experiences of trial recruitment focussing on qualitative research , which allows them to articulate their views in their own words . Discussion Parents want to do their best for their children , and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role . Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick . They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the ' wrong ' decision . They make judgements about the threat of the child 's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts . Individual parents will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values , the medical situation of their child and the nature of the trial . Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussion s to the needs and situation of individual parents . In this way , parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make . Summary Discussing r and omised controlled trials and gaining and providing informed consent is challenging . The unique position of parents in giving proxy consent for their child adds to this challenge . Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials , and ultimately , may help improve the experience of trial recruitment for all parties PURPOSE Loss of participants in r and omized clinical trials threatens the validity of study findings . The purpose of this study was to determine pre-r and omization predictors of study completion status throughout the course of a r and omized clinical trial involving young children with type 1 diabetes and their primary caregivers . METHODS An intervention to improve adherence to the diabetes treatment regimen was delivered as part of the child 's regular 3-month diabetes clinic visit . The study protocol involved 7 clinic visits across 18 months for the Immediate Treatment group and 9 clinic visits across 24 months for the Delayed Treatment group . Among those who completed the study and regardless of treatment group , participants were categorized into two groups : On-Time Completers ( n=41 ) and Late Completers ( n=39 ) . Demographic , disease , and psychosocial characteristics of children and their primary caregivers measured prior to study r and omization were tested for their association with the participants ' completion status ( i.e. , On-Time Completers , Late Completers , or Withdrawals ) . RESULTS Of the 108 participants , 28 ( 25.9 % ) withdrew and 80 ( 74.1 % ) completed the study . On-Time Completers ( i.e. , study completed within 4 months of expected date ) were more likely to have private insurance and primary caregivers with some college education . Late Completers ( i.e. , study completion took longer than 4 months ) were more likely to be boys and to have primary caregivers who reported mild to moderate levels of depression . Children who subsequently withdrew from the study reported poorer diabetes-related quality of life and poorer school-related quality of life at study inception and were more likely to have primary caregivers who did not work outside the home . CONCLUSIONS Pre-r and omization screening of participants on both demographic and psychological variables may help identify those at greatest risk for study withdrawal or poor study protocol adherence , permitting the investigators to develop retention strategies aim ed at this high-risk group Background Despite important implication s for the budgets , statistical power and generalisability of research findings , detailed reports of recruitment and retention in r and omised controlled trials ( RCTs ) are rare . The NOURISH RCT evaluated a community-based intervention for first-time mothers that promoted protective infant feeding practice s as a primary prevention strategy for childhood obesity . The aim of this paper is to provide a detailed description and evaluation of the recruitment and retention strategies used . Methods A two stage recruitment process design ed to provide a consecutive sampling framework was used . First- time mothers delivering healthy term infants were initially approached in postnatal wards of the major maternity services in two Australian cities for consent to later contact ( Stage 1 ) . When infants were approximately four months old mothers were re-contacted by mail for enrolment ( Stage 2 ) , baseline measurements ( Time 1 ) and subsequent r and om allocation to the intervention or control condition . Outcomes were assessed at infant ages 14 months ( Time 2 ) and 24 months ( Time 3 ) . Results At Stage 1 , 86 % of eligible mothers were approached and of these women , 76 % consented to later contact . At Stage 2 , 3 % had become ineligible and 76 % could be recontacted . Of the latter , 44 % consented to full enrolment and were allocated . This represented 21 % of mothers screened as eligible at Stage 1 . Retention at Time 3 was 78 % . Mothers who did not consent or discontinued the study were younger and less likely to have a university education . Conclusions The consent and retention rates of our sample of first time mothers are comparable with or better than other similar studies . The recruitment strategy used allowed for detailed information from non-consenters to be collected ; thus selection bias could be estimated . Recommendations for future studies include being able to contact participants via mobile phone ( particularly text messaging ) , offering home visits to reduce participant burden and considering the use of financial incentives to support participant retention . Trial registration Australian and New Zeal and Clinical Trials Registry Number The hierarchy of evidence in assessing the effectiveness of interventions or treatments is explained , and the gold st and ard for evaluating the effectiveness of interventions , the r and omised controlled trial , is discussed . Issues that need to be considered during the critical appraisal of r and omised controlled trials , such as assessing the validity of trial methodology and the magnitude and precision of the treatment effect , and deciding on the applicability of research results , are discussed . Important terminologies such as r and omisation , allocation concealment , blinding , intention to treat , p values , and confidence intervals are explained OBJECTIVES To operationalize a comprehensive description of attrition , including pre- inclusion , dropout , and attrition due to intermittent missing data , and to test a predictive model of attrition using a data set from a r and omized controlled intervention in pediatric asthma . METHODS Participants included children , ages 4 - 12 , diagnosed with asthma and their caregivers . Demographic variables and outcome measures of asthma morbidity were examined in 327 families to determine their association with attrition . RESULTS Families who did not complete r and omization and the intervention tended to have younger caregivers than did completers . Caregiver age emerged as the most consistent predictor of pre- inclusion and dropout attrition . There were no significant predictors of attrition due to intermittent missing data . CONCLUSION Younger caregivers may be at particular risk for attrition in pediatric asthma intervention studies and warrant special attention by investigators OBJECTIVE To examine attrition variables in r and omized controlled trials of cognitive behavioral interventions for children with chronic illnesses . METHODS We examined attrition rates reported on 40 r and omized cognitive behavioral interventions published in six pediatric research journals , during the years 2002 - 2007 . Intervention focus was limited to children with a chronic medical condition , such as asthma , obesity , arthritis , diabetes , cancer , sickle cell disease , and cystic fibrosis . RESULTS Mean rate of enrollment refusal was 37 % ( range 0 - 75 % ) . Mean attrition rate was 20 % ( range 0 - 54 % ) for initial follow-up and 32 % ( range 0 - 59 % ) for extended follow-up . Of the review ed articles , 40 % included a CONSORT diagram . CONCLUSIONS Strategies that can be used to limit attrition include tailoring recruitment to the study population , providing personalized feedback , maintaining consistent study procedures , providing incentives , and using intensive tracking measures . There is a need for st and ardized definitions and reporting of attrition rates in r and omized cognitive behavioral intervention studies OBJECTIVES Survival rates for childhood cancer have improved substantially partly as a result of national and international r and omized clinical trials ( RCT ) . However , the decision for families is complex and emotional . Our aim was to describe the views of mothers of children newly diagnosed with ALL regarding consent to r and omized controlled trials . DESIGN Qualitative interview to explore mothers knowledge , and reasons for involving their child in RCTs . Interviews took place in mothers ' homes . PARTICIPANTS Fifty mothers of children with newly diagnosed ALL ( age 4 - 16 years ; mean = 7.4 ) recruited through research nurses at outpatient appointments . RESULTS All but three families had consented for their child to be treated in the RCT , although there was wide variation in their underst and ing of the aims , costs and benefits . Most mothers reported the aim of the trial to compare ' old ' and ' new ' treatments . CONCLUSION Despite detailed verbal and written information , mothers were poorly informed about the purpose of the trial , and possibility of side effects . Individual preferences for either st and ard or new treatment were routinely reported . The data raise questions about the extent to which families give truly informed consent to recruitment of their child to an RCT A significant percentage of children with disruptive behavior disorders do not receive mental health assistance . Utilization is lowest among groups whose children are at greatest risk . To increase the availability , accessibility , and cost efficacy of parent training programs , this prospect i ve r and omized trial compared a large group community-based parent training program to a clinic-based individual parent training ( PT ) programs . All families of junior kindergartners in the Hamilton public and separate school boards were sent a checklist regarding problems at home . Those returning question naires above the 90th percentile were block r and omly assigned to : ( 1 ) a 12-week clinic-based individual parent training ( Clinic/Individual ) , ( 2 ) a 12-week community-based large group parent training ( Community/Group ) , or ( 3 ) a waiting list control condition . Immigrant families , those using English as a second language , and parents of children with severe behaviour problems were significantly more likely to enroll in Community/Groups than Clinic/Individual PT . Parents in Community/Groups reported greater improvements in behaviour problems at home and better maintenance of these gains at 6-month follow-up . A cost analysis showed that , with groups of 18 families , Community/Groups are more than six times as cost effective as Clinic/Individual programs Women with inadequate prenatal care were recruited to a multi-component parenting intervention study . Because it was anticipated that this high-risk population might present challenges to retention , a variety of strategies were employed to maintain their participation in the study . This report review s the results of these retention efforts and compares the population that completed the study versus those that terminated prior to study completion . Two hundred and eighty-six women were r and omized to an intervention or control group . Careful tracking of the mothers , offering incentives for completing various study activities and providing a culturally competent staff were among the strategies employed to maintain participation . Comparison
Output:
| Parent characteristics ( e.g. ethnicity , age , education , socioeconomic status ( SES ) ) were the most commonly reported predictors of participation for both recruitment and retention .
Being young , less educated , of an ethnic minority and having low SES appear to be barriers to participation in RCTs although there was little agreement between studies .
Conclusion Parent characteristics may predict participation of children and their families to RCTs ; however , there was a lack of consensus .
Whilst sociodemographic variables may be useful in identifying which groups are least likely to participate they do not provide insight into the processes and barriers to participation for children and families . |
MS212934 | ***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: Seventy-two patients complaining of abdominal pain were studied in a double blind trial with otilonium bromide ( OB ) ( 40 mg tid or placebo ) . In our patients we performed , before and after the treatment , a clinical evaluation ( symptom variations ) and functional studies ( sigmoid manometry during bowel distension ) . As regards clinical parameters , otilonium bromide significantly reduced abdominal pain and bloating and significantly increased ( p less than 0.02 ) the pain threshold . However the comparison with the placebo group did not show any difference between the two groups . Sigmoid motility during distension was significantly reduced ( p less than 0.05 ) in OB group , whereas it did not change in the placebo group . We can conclude that , in irritable bowel syndrome ( IBS ) patients , OB is able to improve symptoms and to reduce stimulated motor activity of the sigmoid A double-blind controlled therapeutic trial of factorial design was used to study the therapeutic effects of lorazepam , hyoscine butylbromide , and ispaghula husk in 12 r and omised blocks of eight patients with the irritable bowel syndrome ( IBS ) . Each of the three agents caused a sustained symptomatic improvement in some of the patients , although only with ispaghula was the difference between the real and dummy preparation statistically significant . When the eight possible combinations of treatment were analysed none of the 12 patients who received only dummy preparations of the three agents had maintained any improvement over the three months of the trial . Seven patients improved among the 12 who received potent preparations of all three agents , and between four and six patients improved in the groups receiving one or two of the potent preparations . These therapeutic results , though far from perfect , show that the types of drug commonly used to treat IBS are of some value and may be additive in their effects . Similar combinations of other therapeutic agents may be more effective , but it will be possible to determine this only by carrying out factorial therapeutic trials As professionals , we want to use the best treatments ; as patients , we want to be given them . Knowing whether an intervention works ( or does not work ) is fundamental to clinical decision making . However , clinical decision making involves more than simply taking published results of research directly to the bedside . Physicians need to consider how similar their patients are to those in the published studies , to take the values and preferences of their patients into account , and to consider their own experience with a given test or treatment . Evidence from clinical research is becoming increasingly important in medical- practice decisions as more and better evidence is published . But when is the evidence strong enough to justify changing a practice ? Individual studies that involve only small numbers of patients may have results that are distorted by the r and om play of chance and thus lead to less than optimal decisions . As is clear from other papers in this series , systematic review s identify , critically appraise , and review all the relevant studies on a clinical question and are more likely to give a valid answer . They use explicit methods and quality st and ards to reduce bias . Their results are the closest we can come to reaching the truth given our current state of knowledge . The questions about an intervention that a systematic review should answer are the following : 1 . Does it work ? 2 . If it works , how well does it work in general and compared with placebo , no treatment , or other interventions that are currently in use ? 3 . Is it safe ? 4 . Will it be safe and effective for my patients ? Whereas the critical appraisal and qualitative synthesis provided by review articles can be interpreted directly , the numerical products of quantitative review s can be more difficult to underst and and apply in daily clinical practice . This paper provides guidance on how to interpret the numerical and statistical results of systematic review s , translate these results into more underst and able terms , and apply them directly to individual patients . Many of these principles can also be used to interpret the numerical results of individual clinical studies . They are particularly relevant to systematic review s , however , because such review s contain more information than do primary studies and often exert greater influence than do individual studies . Making Sense of the Numerical Results of Clinical Studies Although the results of clinical studies can be expressed in intuitively meaningful ways , such results do not always easily translate into clinical decision making . For example , results are frequently expressed in terms of risk , which is an expression of the frequency of a given outcome . ( Risks are probabilities , which can vary between 0.0 and 1.0 . A probability of 0.0 means that the event will never happen , and a probability of 1.0 means that it always happens . ) Consider a hypothetical study of the recurrence of migraine headaches in a control group receiving placebo and a treatment group receiving a new antimigraine preparation , drug M ( a secondary prevention trial ) . Suppose that at the end of the trial , migraines recurred in 30 % of the control group ( the risk for recurrence was 0.30 ) but in only 5 % of the drug M group ( risk of 0.05 ) ( Table 1 ) . Table 1 . Numerical Expression of Hypothetical Clinical Trial Results The outcomes of the study are clear enough for the two groups when they are examined separately . But clinicians and patients are more interested in the comparative results , that is , the outcome in one group relative to the outcome in the other group . This overall ( comparative ) result can be expressed in various ways . For example , the relative risk , which is the risk in the treatment group relative to that in the control group , is simply the ratio of the risks in the two groups . In other words , relative risk is the risk in the treatment group divided by that in the control group , 0.05 0.30 , or 0.17 . The comparison can also be expressed as the reduction in relative risk , which is the ratio between the decrease in risk ( in the treatment group ) and the risk in the control group , 0.25 0.30 , or 0.83 ( Table 1 ) . ( The relative risk reduction can also be calculated as 1 relative risk ) . Although the clinical meaning of relative risk ( and relative risk reduction ) is reasonably clear , relative risk has the distinct disadvantage that a given value ( for example , 0.17 ) is the same whether the risk with treatment decreases from 0.80 to 0.14 , from 0.30 to 0.05 , from 0.001 to 0.00017 , and so forth . The clinical implication s of these changes clearly differ from one another enormously and depend on the specific disease and intervention . An important alternate expression of comparative results , therefore , is the absolute risk reduction . Absolute risk reduction is determined by subtracting the risk in one group from the risk in the other ( for example , the risk in the treatment group is subtracted from the risk in the placebo group ) . In the case of our migraine study , the absolute risk reduction would be 0.30 0.05 , which equals 0.25 , or 25 percentage points . In contrast , for a study in which the risk decreased from 0.001 to 0.00017 , the absolute risk reduction would be only 0.00083 , or 0.083 percentage points , which is a trivial change in comparison ( Table 1 ) . This arithmetic emphasizes the difficulty of expressing the results of clinical studies in meaningful ways . Relative risk and relative risk reduction clearly give a quantitative sense of the effects of an intervention in proportional terms but provide no clue about the size of an effect on an absolute scale . In contrast , although it tells less about proportional effects , absolute risk says a great deal about whether an effect is likely to be clinical ly meaningful . Despite this benefit , even absolute risk is problematic because it is a dimensionless , abstract number ; that is , it lacks a direct connection with the clinical situation in which the patient and physician exist . However , another way of expressing clinical research results can provide that clinical link : the number needed to treat ( NNT ) . Number Needed To Treat The NNT for a given therapy is simply the reciprocal of the absolute risk reduction for that treatment [ 1 , 2 ] . In the case of our hypothetical migraine study ( in which risk decreased from 0.30 without treatment with drug M to 0.05 with treatment with drug M , for a relative risk of 0.17 , a relative risk reduction of 0.83 , and an absolute risk reduction of 0.25 ) , the NNT would be 1 0.25 , or 4 . In concrete clinical terms , an NNT of 4 means that you would need to treat four patients with drug M to prevent migraine from recurring in one patient . To emphasize the difference between the concepts embodied in NNT and relative risk , recall the various situations mentioned above , in all of which the relative risk was 0.17 but in which the absolute risk decreased from 0.80 to 0.14 in one case and from 0.001 to 0.00017 in another . Note that the corresponding NNTs in these two other cases are 1.5 and 1204 , respectively : that is , you would need to treat 1.5 and 1204 patients to obtain a therapeutic result in these two situations compared with 4 patients with drug M ( Table 1 ) . The NNT can be calculated easily and kept as a single numerical reminder of the effectiveness ( or , as we will see , the potential for harm ) of a particular therapy . As we suggested , the NNT has the crucial advantage of direct applicability to clinical practice because it shows the effort that is required to achieve a particular therapeutic target . The NNT has the additional advantage that it can be applied to any beneficial outcome or any adverse event ( when it becomes the number needed to harm [ NNH ] ) . The concept of NNT always refers to a comparison group ( in which patients receive placebo , no treatment , or some other treatment ) , a particular treatment outcome , and a defined period of treatment . In other words , the NNT is the number of patients that you will need to treat with drug or treatment A to achieve an improvement in outcome compared with drug or treatment B for a treatment period of C weeks ( or other unit of time ) . To be fully specified , NNT and NNH must always specify the comparator , the therapeutic outcome , and the duration of treatment that is necessary to achieve the outcome . Important Qualities of the Number Needed To Treat The NNT is treatment specific . It describes the difference between treatment and control in achieving a particular clinical outcome . Table 2 shows NNTs from a selection of systematic review s and large r and omized , controlled trials . Table 2 . Numbers Needed To Treat from Systematic Review s and R and omized , Controlled Trials A very small NNT ( that is , one that approaches 1 ) means that a favorable outcome occurs in nearly every patient who receives the treatment and in few patients in a comparison group . Although NNTs close to 1 are theoretically possible , they are almost never found in practice . However , small NNTs do occur in some therapeutic trials , such as those comparing antibiotics with placebo in the eradication of Helicobacter pylori infection or those examining the use of insecticide for head lice ( Table 2 ) . An NNT of 2 or 3 indicates that a treatment is quite effective . In contrast , such prophylactic interventions as adding aspirin to streptokinase to reduce 5-week vascular mortality rates after myocardial infa rct ion may have NNTs as high as 20 to 40 and still be considered clinical ly effective . Limitations of the Number Needed To Treat Although NNTs are powerful instruments for interpreting clinical effects , they also have important limitations . First , an NNT is generally expressed as a single number , which is known as its point estimate . As with all experimental measurements , however , the true value of the NNT can be higher or lower than the point estimate determined through clinical studies . The 95 % CIs of the NNT are useful in this regard because they provide an indication that Background : Alverine citrate has been used in the treatment of irritable bowel syndrome for many years Methods for combining data from several studies exist and appear to be quite useful . None satisfactorily addresses the question of what studies should be combined . This issue is the most serious method ological limitation . Even studies with statistically significant interaction might still be combined if the effect were in the same direction . Thus , substantial scientific input is required as to what criteria must be met by each potential study . Much can be learned from combining or pooling data but it must be done cautiously . Pooling exercises do not replace well design ed prospect i ve clinical trials . Efforts for establishing basic design criteria to allow for multicentre and multicountry trials to be more easily combined might be useful . To evaluate the efficacy of otilonium bromide , a spasmolytic agent , in the treatment of irritable bowel syndrome using modern and vali date d diagnostic criteria BACKGROUND & AIMS Irritable bowel syndrome ( IBS ) is subtyped as IBS with diarrhea ( IBS-D ) or IBS with constipation ( IBS-C ) based on Rome II guidelines . The remaining group is considered as having mixed IBS ( IBS-M ) . There is no st and ard definition of an alternator ( IBS-A ) , in which bowel habit changes over time . Our aim was to use Rome II criteria to prospect ively assess change in bowel habit for more than 1 year to underst and IBS-A. METHODS Female patients ( n=317 ) with IBS entering a National Institutes of Health treatment trial were studied at baseline with question naires and 2-week daily diary cards of pain and stool frequency and consistency . Studies were repeated at the end of treatment ( 3 months ) and at four 3-month intervals for one more year . Algorithms to classify subjects into IBS-D , IBS-C , and IBS-M groups used diary card information and modified Rome II definitions . Changes in bowel habit at 3-month intervals were then assessed using these surrogate diary card measures . RESULTS At baseline , 36 % had IBS-D , 31 % IBS-M , and 34 % IBS-C. Except for stool frequency , there were no differences between groups . While the proportion of subjects in each subgroup remained the same over the year , most individuals ( more than 75 % ) changed to either of the other 2 subtypes at least once . IBS-M was the least stable ( 50 % changed out by 12 weeks ) . Patients were more likely to transition between IBS-M and IBS-C than between IBS-D and IBS-M. Notably , only 29 % switched between the IBS-D and IBS-C subtypes over the year . CONCL
Output:
| Antispasmodics were more effective than placebo in IBS , without any significant adverse events .
The addition of simethicone improved the properties of the antispasmodic agents , as seen with the alverine/simethicone and pinaverium/simethicone combinations |
MS212935 | ***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: BACKGROUND We conducted a phase I/II r and omized placebo-controlled trial with the aim of exploring whether priming with a low intradermal dose of a multiclade , multigene HIV-1 DNA vaccine could improve the immunogenicity of the same vaccine given intramuscularly prior to boosting with a heterologous HIV-1 MVA among healthy adults in Dar es Salaam , Tanzania . METHODS Sixty HIV-uninfected volunteers were r and omized to receive DNA plasmid vaccine 1 mg intradermally ( i d ) , n=20 , or 3.8 mg intramuscularly ( i m ) , n=20 , or placebo , n=20 , using a needle-free injection device . DNA plasmids encoding HIV-1 genes gp160 subtype A , B , C ; rev B ; p17/p24 gag A , B and Rtmut B were given at weeks 0 , 4 and 12 . Recombinant MVA ( 10(8)pfu ) expressing HIV-1 Env , Gag , Pol of CRF01_AE or placebo was administered i m at month 9 and 21 . RESULTS The vaccines were well tolerated . Two weeks after the third HIV-DNA injection , 22/38 ( 58 % ) vaccinees had IFN-γ ELISpot responses to Gag . Two weeks after the first HIV-MVA boost all 35 ( 100 % ) vaccinees responded to Gag and 31 ( 89 % ) to Env . Two to four weeks after the second HIV-MVA boost , 28/29 ( 97 % ) vaccinees had IFN-γ ELISpot responses , 27 ( 93 % ) to Gag and 23 ( 79 % ) to Env . The id-primed recipients had significantly higher responses to Env than i m recipients . Intracellular cytokine staining for Gag-specific IFN-γ/IL-2 production showed both CD8(+ ) and CD4(+ ) T cell responses . All vaccinees had HIV-specific lymphoproliferative responses . All vaccinees reacted in diagnostic HIV serological tests and 26/29 ( 90 % ) had antibodies against gp160 after the second HIV-MVA boost . Furthermore , while all of 29 vaccinee sera were negative for neutralizing antibodies against clade B , C and CRF01_AE pseudoviruses in the TZM-bl neutralization assay , in a P BMC assay , the response rate ranged from 31 % to 83 % positives , depending upon the clade B or CRF01_AE virus tested . CONCLUSIONS This vaccine approach is safe and highly immunogenic . Low dose , i d HIV-DNA priming elicited higher and broader cell-mediated immune responses to Env after HIV-MVA boost compared to a higher HIV-DNA priming dose given i m . Three HIV-DNA priming immunizations followed by two HIV-MVA boosts efficiently induced Env-antibody responses Abstract Background Evaluating experiences of volunteers in an HIV vaccine trial will be useful for the conduct of future trials . The purpose of this study among volunteers who participated in a phase I/II HIV vaccine trial in Dar es Salaam , Tanzania was to assess what characterized their experiences during the trial . Methods We conducted four focus group discussion s with 35 out of the 60 individuals ( women and men ) after the five scheduled vaccinations . An interpretive description approach was applied to data analysis . Results As a result of the trial interventions , both men and women gained confidence in their own abilities to have safer , less risky sexual behaviour . The participants experienced the trial as a way of accessing free [ insured ] medical services . Most of the men said they had gone from self-medication to professional medical consultation . Despite these benefits , the participants faced various challenges during the trial . Such challenges included mistrust of the trial shown by health care providers who were not connected to the trial and discouragement from friends , colleagues and family members who question ed the safety of the trial . However , they managed to cope with these doubts by using both personal and trial related interventions . Conclusion We found that during the phase I/II HIV vaccine trial , participants had both the opportunities and the ability to cope with the doubts from the surrounding community . Follow up visits enhanced the opportunities and individuals ' abilities to cope with the doubts during the trial . Underst and ing this discourse may be useful for the trial implementers when design ing future trials . Trials Registration IS RCT N : IS RCT N90053831 Pan African Clinical Trials Registry ( PACTR ) : Summary : Underst and ing why people join HIV vaccine efficacy trials is critical for trial recruitment and education efforts . We assessed participants ' motivations for joining the VaxGen VAX004 study , a r and omized , double-blind , placebo-controlled , phase 3 multicenter trial . Of 5417 participants , 94 % were men who have sex with men ( MSM ) and 6 % were women at risk for heterosexual transmission of HIV . Most participants gave altruistic reasons for trial participation : 99 % reported having joined to help find an HIV vaccine , and 98 % reported having joined to help their community . Some gave more personal reasons : 56 % joined to reduce risk behavior and 46 % joined to get protection from HIV . Additional reasons related to receiving services or compensation included to obtain information about HIV ( 75 % ) , to receive free HIV testing ( 34 % ) , and for financial reimbursement ( 14 % ) . Multivariate logistic regression analysis showed that female participants were significantly more motivated than male participants to join the trial for protection and to receive services or compensation ( all P < 0.05 ) . Participants with 13 or more sex partners in the 6 months before enrollment were more likely than those with fewer sex partners to report having joined the trial for protection but less likely to have joined to reduce risk behavior ( both P < 0.05 ) . Because many participants reported personal protection from HIV as their reason for joining , vaccine trial risk-reduction counseling should continue to emphasize the placebo-controlled trial design and unknown efficacy of the test product , particularly for women and persons with large numbers of sex partners . Because a significant minority of participants reported joining to receive HIV information , HIV testing , and financial reimbursement , a need is indicated for provision of HIV prevention services outside research trials and for monitoring to ensure that participants are not motivated to join trials for financial gain Live attenuated viral vectors that express human immunodeficiency virus ( HIV ) antigens are being developed as potential vaccines to prevent HIV infection . The first phase 2 trial with a canarypox vector ( vCP205 , which expresses gp120 , p55 , and protease ) was conducted in 435 volunteers with and without gp120 boosting , to exp and the safety data base and to compare the immunogenicity of the vector in volunteers who were at higher risk with that in volunteers at lower risk for HIV infection . Neutralizing antibodies to the MN strain were stimulated in 94 % of volunteers given vCP205 plus gp120 and in 56 % of volunteers given vCP205 alone . CD8(+ ) cytotoxic T lymphocyte cells developed at some time point in 33 % of volunteers given vCP205 , with or without gp120 . Phase 3 field trials with these or similar vaccines are needed , to determine whether efficacy in preventing HIV infection or in slowing disease progression among vaccinees who become infected is associated with the level and types of immune responses that were induced by the vaccines in this study Behavioral and social issues were investigated in 363 phase I/II preventive HIV-1 vaccine trial volunteers in Thail and . These issues included risk behavior , HIV knowledge , distress , and social consequences of vaccine trial participation . Data were collected at baseline and at 4- , 8- , and 12-month follow-up visits . Volunteers reported relatively low levels of risk behaviors at baseline and at follow-up . Overtly negative reactions from family or friends were reported by 5.9 % . No experiences of discrimination in employment , health care , or insurance were reported . Mean levels of distress were low throughout the trial , and HIV-related knowledge was high , although it was common to consider the possibility of HIV transmission through casual contact . Findings add to the evidence that preventive HIV vaccine trials are feasible in Thail and Objectives : To describe recruitment , screening and baseline characteristics of injection drug users ( IDU ) participating in a phase III HIV vaccine ( AIDSVAX ® B/E ; VaxGen , USA ) trial and to compare enrollment characteristics between trial participants and 1209 IDU from a 1995–1998 vaccine trial preparatory cohort for changes that might impact trial design assumptions . Methods : Enrollment for both studies was conducted at Bangkok narcotic treatment clinics , where a st and ardized question naire was administered on demographics , risk behavior and incarceration history over the previous 6 months . Results : During 1999–2000 , 4943 IDU were screened for enrollment ; successful sources of recruitment included clinic attendees ( 43.4 % ) , an IDU referral program ( 20.4 % ) and preparatory cohort participants ( 14.7 % ) . Of those screened , 1689 ( 34 % ) were HIV seropositive ( HIV subtype B 23.6 % ; subtype E 76.4 % ) . Of the 2545 enrolled , 93.4 % were male . Compared with cohort IDU , trial IDU were younger ( mean age : 28.8 versus 31.3 years ) , better educated ( secondary level or higher : 67.2 % versus 58.7 % ) , and less likely to inject drugs daily ( 39.4 % versus 90.4 % ) ; they were more likely to have been incarcerated ( 78.4 % versus 65.7 % ) , have recently injected stimulants ( 14.8 % versus 5.8 % ) and tranquilizers ( 11.5 % versus 2.3 % ) , and obtained needles/syringes from a source other than a pharmacist ( 7.2 % versus 3.9 % ) ( all P ⩽ 0.003 ) . Conclusions : IDU at high risk for HIV have been successfully enrolled in the AIDSVAX ® B/E efficacy trial . Only minor epidemiologic differences were found at enrollment between trial and preparatory cohort IDU . The latter has proven critical in guiding trial design ; results are expected in late 2003 Objective : To describe recruitment and baseline epidemiologic characteristics of volunteers in the first phase 3 placebo-controlled trial of a recombinant gp120 HIV vaccine ( AIDSVAX B/B ) . Methods : Volunteers were gay/bisexual men or women at risk for sexually transmitted HIV infection . Recruitment strategies , demographics , and risk factors were assessed . HIV status was determined by st and ard HIV-1 antibody assays . Seronegative/viremic HIV infection at enrollment was determined using the HIV-1 nucleic acid test . Results : From June 1998 through October 1999 , 5417 of 7185 volunteers screened were enrolled at 61 sites in the United States , Canada , and The Netherl and s. Successful recruitment methods included distribution of study information at gay venues , advertising and media coverage , and referrals from volunteers . Most volunteers were altruistically motivated , men ( 98 % ) , young ( median , 36 years ) , white ( 83 % ) , well educated ( 61 % college education or more ) , and at high risk for HIV during the 6 months before enrollment . At baseline , 14 were HIV infected ( 12 were seronegative but viremic ; 2 were seropositive and viremic ) . Conclusion : Men and women at high risk for sexually transmitted HIV infection were successfully recruited for the first phase 3 HIV vaccine efficacy trial . Knowledge of recruitment and baseline epidemiologic characteristics of participants in this trial will provide valuable guidance for design ing and conducting future trials Background : The first multicenter , international National Institutes of Allergy and Infectious Diseases (NIAID)-sponsored HIV vaccine trial took place in Brazil , Haiti , Peru and Trinidad . This r and omized , double-blind , placebo-controlled , phase 2 trial evaluated the safety and immunogenicity of a clade B-derived , live canarypox HIV vaccine , vCP1452 . vCP1452 was administered alone or with a heterologous boost of MN rgp120 glycoprotein . The trial was pivotal in deciding whether these vaccines advanced to phase 3 efficacy trials . Methods : Forty seronegative volunteers per site were r and omized to ALVAC alone , ALVAC plus MN rgp120 , or placebo in a 0 , 1 , 3 , and 6 month schedule . Immunogenicity was assayed by chromium-release cytotoxic T lymphocyte ( CTL ) responses ; interferon-gamma ( IFN-γ ) enzyme-linked immunosorbent spot assays ( ELISpot ) ; lymphocyte proliferation assays ( LPA ) ; neutralization ; and enzyme-linked immunosorbent assays ( ELISA ) . Results : Enrollment and follow-up were excellent . Both vaccines were well tolerated . Neutralizing antibody to the laboratory-adapted MN strain was detected .
Output:
| Analysis of these motivators reveals that they can be categorized as social and personal benefits .
Social benefits were most frequently described on macroscopic , altruistic levels .
Personal benefits were most frequently psychological in nature .
Rates of participation were compared between the OECD and the non-OECD countries . |
MS212936 | ***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 Objective : To compare chemotherapy given at home with outpatient treatment in terms of colorectal cancer patients ' safety , compliance , use of health services , quality of life , and satisfaction with treatment . Design : R and omised controlled trial . Setting : Large teaching hospital . Participants : 87 patients receiving adjuvant or palliative chemotherapy for colorectal cancer . Interventions : Treatment with fluorouracil ( with or without folinic acid or levamisole ) at outpatient clinic or at home . Main outcome measures : Treatment toxicity ; patients ' compliance with treatment , quality of life , satisfaction with care , and use of health re sources . Results : 42 patients were treated at outpatient clinic and 45 at home . The two groups were balanced in terms of age , sex , site of cancer , and disease stage . Treatment related toxicity was similar in the two groups ( difference 7 % ( 95 % confidence interval −12 % to 26 % ) ) , but there were more voluntary withdrawals from treatment in the outpatient group than in the home group ( 14 % v 2 % , difference 12 % ( 1 % to 24 % ) ) . There were no differences between groups in terms of quality of life scores during and after treatment . Levels of patient satisfaction were higher in the home treatment group , specifically with regard to information received and nursing care . There were no significant differences in use of health services . Conclusions : Home chemotherapy seemed an acceptable and safe alternative to hospital treatment for patients with colorectal cancer that may improve compliance and satisfaction with treatment . What is already known on this topic Home chemotherapy programmes have been proposed as an alternative to hospital treatment However , they are more costly , and there is little evidence on their impact on outcomes such as compliance , quality of life , or use of other health services What this study adds Home chemotherapy was not associated with an increased use of health services such as primary care or emergency departments Home chemotherapy had no effect on patients ' quality of life but increased their compliance with treatment and satisfaction , particularly with regard to nursing care Home chemotherapy seems an acceptable and safe alternative to outpatient treatment that may improve compliance with This quasi-experimental longitudinal study documented the impact of a comprehensive cancer informational intervention using information technology on healthcare service use among individuals newly diagnosed with cancer . Women with breast cancer ( n = 205 ) and men with prostate cancer ( n = 45 ) were recruited within 8 weeks of diagnosis at 4 university teaching hospitals in Montreal , Quebec , Canada . The intervention group ( n = 148 ) received a 1-hour training on information technology use , a CD-ROM on cancer , and a list of reputable cancer-related Web sites . The intervention material was available for a period of 8 weeks . The control group ( n = 102 ) received usual care . Self-reported question naires were completed at T1 ( baseline ) , T2 ( 1 week after intervention ) , and T3 ( 3 months after intervention ) . Using multivariate statistics , the experimental group reported significantly more satisfaction with cancer information received compared to the control group . No significant differences were found between experimental and control groups in their reliance on healthcare services . However , women as opposed to men spent more time with nurses , were more satisfied with cancer information received , and relied more heavily on health services . Future research would explore whether the latter observations reflect genuine sex differences or are more contingent on the specific cancer diagnosis The purpose of this study was to test a brief orientation program for reducing anxiety , depressive symptoms , and overall distress in cancer patients at their initial clinic visit . One hundred and fifty consecutively referred patients seen in an oncology outpatient clinic were r and omly assigned to an intervention or usual care control group . The intervention group received a clinic tour , general information about clinic operations , and a question and answer session with an oncology counselor . Outcome measures included the State-Trait Anxiety Inventory ( STAI ) , the Brief Profile of Mood States ( POMS ) , the Center for Epidemiologic Studies -Depression ( CES-D ) Scale , and an oncology clinic question naire which were administered at the initial clinic visit and follow-up . There were no statistically significant clinical or demographic differences between groups at initial assessment . At follow-up , the intervention group had lower state anxiety , lower overall distress , and fewer patients reporting depressive symptoms . Patients in the intervention group demonstrated significantly more knowledge about clinic operations and greater satisfaction with care . These data provide evidence that anxiety , distress and depressive symptoms can be reduced with an orientation program . This finding has particular relevance in the early stages of diagnosis where patients may suffer symptoms of anxiety and depression The purpose of this study was to evaluate the extent to which a new patient information package ( NPIP ) or a mini version of the same package ( mini-NPIP ) reduces emotional distress and meets the informational needs of patients arriving at a tertiary cancer centre for the first time . A comprehensive package , NPIP , consisting of procedural information regarding cancer centre location , description of the health care team , treatment services , research , educational activities , accommodation and community services provided at the centre ; and a condensed version of the same package , mini-NPIP , were developed . Consecutive patients with newly diagnosed breast , gynaecological , lung and prostate cancer , referred to the centre for the first time were prer and omised to receive NPIP , mini-NPIP or no information package . Patients r and omised to NPIP or mini-NPIP were mailed the information package at least one week before their first appointment . On arrival at the centre , patients were administered the Brief Symptom Inventory ( BSI ) which measures psychological distress , and interviewed regarding preferences for information and acceptability of the information packages . Of 465 r and omised patients , 161 were excluded post-r and omisation and 304 completed the entire interview : 100 were r and omised to the NPIP , 102 to the mini-NPIP and 102 to the control group . Emotional distress as measured by the BSI was similar for all groups ( P = 0.98 ) . Most patients preferred to receive the information ( 98 % ) , receive it before the first appointment ( 84 % ) and by mail ( 79 % ) . These preferences were more evident for those given the information packages . The majority of patients found the information packages easy to underst and ( 88 % ) and useful ( 89 % ) , and no differences were detected between packages . The cost of production and dissemination of NPIP was more than double the cost for mini-NPIP : $ 8.93 vs $ 3.98 ( Canadian dollars ) per patient . For patients presenting to a cancer centre for the first time , packages of procedural information do not appear to reduce psychological distress , but are preferred by patients . Given the cost of producing NPIP , mini-NPIP is the preferred approach Abstract Objective : To compare the use and effect of a computer based information system for cancer patients that is personalised using each patient 's medical record with a system providing only general information and with information provided in booklets . Design : R and omised trial with three groups . Data collected at start of radiotherapy , one week later ( when information provided ) , three weeks later , and three months later . Participants : 525 patients started radical radiotherapy ; 438 completed follow up . Interventions : Two groups were offered information via computer ( personalised or general information , or both ) with open access to computer thereafter ; the third group was offered a selection of information booklets . Outcomes : Patients ' views and preferences , use of computer and information , and psychological status ; doctors ' perceptions ; cost of interventions . Results : More patients offered the personalised information said that they had learnt something new , thought the information was relevant , used the computer again , and showed their computer printouts to others . There were no major differences in doctors ' perceptions of patients . More of the general computer group were anxious at three months . With an electronic patient record system , in the long run the personalised information system would cost no more than the general system . Full access to booklets cost twice as much as the general system . Conclusions : Patients preferred computer systems that provided information from their medical records to systems that just provided general information . This has implication s for the design and implementation of electronic patient record systems and reliance on general sources of patient information The primary objective of this study was to test whether specific information given prior to surgery can help patients obtain better pain relief after total knee arthroplasty ( TKA ) . Secondary objectives were to study the impact of preoperative information on state and trait anxiety , satisfaction with pain management and satisfaction with nursing care . The study was an intervention study with two groups of equal size ( n=30 ) . The intervention group was given specific information while the control group received routine information . Pain assessment s were made preoperatively and every 3h for the first three postoperative days , using the visual analogue scale ( VAS ) . The results of this study suggest that information does influence the experience of pain after surgery and related psychological factors . The postoperative pain declined more rapidly for patients in the treatment group , the degree of preoperative state anxiety was lower and they were more satisfied with the postoperative pain management Goals of workBased on meta-analyses regarding the preparation of patients for potentially threatening medical procedures , a DVD , incorporating behavioral role modelling , was developed to prepare patients for chemotherapy and assist them to self-manage side effects . It was hypothesized that patients who watched the DVD ( vs those who did not ) would report ( 1 ) lower anxiety ; ( 2 ) higher self-efficacy related to coping with treatment side effects ; ( 3 ) fewer supportive care needs ; and ( 4 ) higher satisfaction with information received . It was further hypothesized that these effects would be stronger in those perceiving their treatment intent to be curative rather than palliative . Material s and methods Quasi-experimental design using a historical control group was employed . Participants were scheduled to receive their first ever chemotherapy treatment . Group 1 ( usual care ; n = 50 ) was prospect ively recruited before the release of the DVD and group 2 ( DVD plus usual care ; n = 50 ) after the release . Before commencing chemotherapy , all patients completed reliable and valid measures of self-efficacy , anxiety , and supportive care needs . Data was stratified according to perceived treatment intent . Independent sample t tests were performed for each group ( curative vs palliative).Main results Significant differences were found between the usual care and intervention groups : for self-perceived curative patients in relation to self-efficacy for seeking social support ( p = 0.044 ) , with increased confidence in those watching the DVD , and for self-perceived palliative patients in relation to their satisfaction with information about side effects ( p = 0.026 ) , with increased satisfaction in those watching the DVD . Overall , significant differences were found between self-perceived curative vs palliative patients on measures of self-efficacy and supportive care needs , with self-perceived curative patients reporting more confidence and fewer needs . Conclusions The educational DVD was considered highly acceptable by patients and was found to increase self-efficacy and reduce supportive care needs . Hence , it is appropriate to give to patients before face-to-face chemotherapy education . Additional pretreatment education is recommended , particularly for self-perceived palliative patients , to reduce their pretreatment anxiety and enhance their confidence in coping with treatment AIM The aim of this project was to produce audiovisual patient information , which was user friendly and fit for purpose . The purpose of the audiovisual patient information is to inform patients about r and omized controlled trials , as a supplement to their trial-specific written information sheet . BACKGROUND Audiovisual patient information is known to be an effective way of informing patients about treatment . User involvement is also recognized as being important in the development of service provision . The aim of this paper is ( i ) to describe and discuss the process of developing the audiovisual patient information and ( ii ) to highlight the challenges and opportunities , thereby identifying implication s for practice . A future study will test the effectiveness of the audiovisual patient information in the cancer clinical trial setting . METHODS An advisory group was set up to oversee the project and provide guidance in relation to information content , level and delivery . An expert panel of two patients provided additional guidance and a dedicated operational team dealt with the logistics of the project including : ethics ; finance ; scriptwriting ; filming ; editing and intellectual property rights . RESULTS Challenges included the limitations of filming in a busy clinical environment , restricted technical and financial re sources , ethical needs and issues around copyright . There were , however , substantial opportunities that included utilizing creative skills , meaningfully involving patients , teamworking and mutual appreciation of clinical , multidisciplinary and technical expertise . CONCLUSION Developing audiovisual patient information is an important area for nurses to be involved with . However , this must be performed within the context of the multiprofessional team . Teamworking , including patient involvement , is crucial as a wide variety of expertise is required . RELEVANCE TO CLINICAL PRACTICE Many aspects of the process are transferable and will provide information and guidance for nurses , regardless of specialty , considering developing this format of patient information This study tested the efficacy of a pilot orientation program in reducing distress levels of patients with newly diagnosed cancer . Thirty-three consecutive patients were r and omly assigned to an intervention or to a usual-care control group . The intervention group received a clinic tour , general information , and the opportunity to pose questions to an oncology counselor . The dependent variables were measured by the Profile of Mood States-Short Form-Total Mood Disturbance Scale and the State Trait Anxiety Inventory . Scores on the dependent measures were significantly lower in the intervention group . These results suggest that a simple orientation can greatly benefit patients with newly diagnosed cancer . The orientation may reduce anxiety and overall distress by helping patients manage novelty and unpredictability in the unfamiliar clinic setting . This intervention can be delivered within the context of a busy hematology/oncology outpatient clinic Targeted treatment education for cancer patients has the potential to promote adjustment through assisting patients to participate in treatment decision making , comply with treatment regimens and cope more effectively with treatment side effects . A quasi-experimental longitudinal pre-test post-test and follow-up design was used to assess the effect of a patient education video about radiation therapy on patients ' psychological distress , knowledge about radiation therapy , self-efficacy about coping with treatment and physical symptoms . Patients with head and neck ( n=26 ) and breast cancer ( n=66 ) were recruited into the study and allocated into control and intervention groups . No significant differences were found between
Output:
| This review has demonstrated the feasibility and some potential benefits of orientation interventions .
There was a low level of evidence suggesting that orientation interventions can reduce distress in patients .
However , most of the other outcomes remain inconclusive ( patient knowledge recall/ satisfaction ) . |
MS212937 | ***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 effect of permethrin-treated wall cloths ( Mbu cloth ) on malaria parasitaemia prevalences and malaria morbidity , was evaluated in a population of over 10,000 for a period of three years in the Marigat area , Baringo District , Kenya . The use of the treated cloth in 2,000 houses result ed in significantly lower rates of malaria parasite prevalences with an overall reduction rate of 73 % ( P < 0.001 ) in the treated area . Control areas had an initial increase in rate of malaria parasite prevalence of 30 % and later a reduction of 31 % . There was a slight reduction in spleen rates in the control and treated areas but it was not significant for either between the surveys or among the villages Abstract Objective : To assess the impact of a social marketing programme for distributing nets treated with insecticide on malarial parasitaemia and anaemia in very young children in an area of high malaria transmission . Design : Community cross sectional study . Annual , cross sectional data were collected at the beginning of the social marketing campaign ( 1997 ) and the subsequent two years . Net ownership and other risk and confounding factors were assessed with a question naire . Blood sample s were taken from the children to assess prevalence of parasitaemia and haemoglobin levels . Setting : 18 villages in the Kilombero and Ulanga districts of southwestern Tanzania . Participants : A r and om sample of children aged under 2 years . Main outcome measures : The presence of any parasitaemia in the peripheral blood sample and the presence of anaemia ( classified as a haemoglobin level of ≤80 g/l ) . Results : Ownership of nets increased rapidly ( treated or not treated nets : from 58 % to 83 % ; treated nets : from 10 % to 61 % ) . The mean haemoglobin level rose from 80 g/l to 89 g/l in the study children in the successive surveys . Overall , the prevalence of anaemia in the study population decreased from 49 % to 26 % in the two years studied . Treated nets had a protective efficacy of 62 % ( 95 % confidence interval 38 % to 77 % ) on the prevalence of parasitaemia and of 63 % ( 27 % to 82 % ) on anaemia . Conclusions : These results show that nets treated with insecticide have a substantial impact on morbidity when distributed in a public health setting Malaria vector mosquitoes belonging to the Anopheles gambiae complex were studied in four hamlets in The Gambia . All inhabitants were given bednets treated either with a placebo ( milk ) in two hamlets or with the pyrethroid insecticide permethrin ( 500 mg/m2 ) in two other hamlets . Malaria transmission occurred mainly during a few weeks of the rainy season , in September and October 1987 . The indoor resting densities of mosquitoes in permethrin-treated hamlets were reduced , and we estimated over 90 % reduction in biting on man by An . gambiae Giles sensu stricto in these hamlets . No mosquitoes were found under permethrin-treated bednets compared with eighty-one recovered from placebo-treated bednets . Mosquitoes exited more readily from rooms where permethrin-treated bednets were used than from rooms with placebo-treated nets . The annual mean probability that a child would receive an infective bite was estimated to be 0.09 in hamlets with insecticide-treated bednets , compared with 1.9 where placebo-treated bednets were used . Permethrin-treated bednets are therefore recommended as a means of effectively reducing the risk of exposure to malaria transmission , particularly in areas of low seasonal transmission BACKGROUND Malaria remains a major cause of mortality and morbidity in Africa . Many approaches to malaria control involve reducing the chances of infection but little is known of the relations between parasite exposure and the development of effective clinical immunity so the long-term effect of such approaches to control on the pattern and frequency of malaria can not be predicted . METHODS We have prospect ively recorded paediatric admissions with severe malaria over three to five years from five discrete communities in The Gambia and Kenya . Demographic analysis of the communities exposed to disease risk allowed the estimation of age-specific rates for severe malaria . Within each community the exposure to Plasmodium falciparum infection was determined through repeated parasitological and serological surveys among children and infants . We used acute respiratory-tract infections ( ARI ) as a comparison . FINDINGS 3556 malaria admissions were recorded for the five sites . Marked differences were observed in age , clinical spectrum and rates of severe malaria between the five sites . Paradoxically , the risks of severe disease in childhood were lowest among population s with the highest transmission intensities , and the highest disease risks were observed among population s exposed to low-to-moderate intensities of transmission . For severe malaria , for example , admission rates ( per 1000 per year ) for children up to their 10th birthday were estimated as 3.9 , 25.8 , 25.9 , 16.7 , and 18.0 in the five communities ; the forces of infection estimated for those communities ( new infections per infant per month ) were 0.001 , 0.034 , 0.050 , 0.093 , and 0.176 , respectively . Similar trends were noted for cerebral malaria and for severe malaria anaemia but not for ARI . Mean age of disease decreased with increasing transmission intensity . INTERPRETATION We propose that a critical determinant of life-time disease risk is the ability to develop clinical immunity early in life during a period when other protective mechanisms may operate . In highly endemic areas measures which reduce parasite transmission , and thus immunity , may lead to a change in both the clinical spectrum of severe disease and the overall burden of severe malaria morbidity The malaria incidence and prevalence rates among children who slept under permethrin-impregnated mosquito nets in four villages near Madang , Papua New Guinea , were compared with the rates among children who slept under unimpregnated nets in four paired control villages . Immediately following a parasitological survey in the eight villages , malaria parasites were cleared from the children with chemotherapy , and the mosquito nets in the four experimental villages were impregnated with permethrin . Follow-up parasitological surveys were performed 4 and 10 weeks later . Sporozoite rates in female mosquitos of the Anopheles punctulatus complex decreased significantly in two of the experimental villages after impregnation . Also , the incidence of Plasmodium falciparum between the 4-week and 10-week surveys was significantly lower among the 0 - 4-year olds in villages with impregnated nets than in those with unimpregnated nets , leading to reduced prevalence of P. falciparum in this age group . Use of permethrin-impregnated nets had no effect on the incidence or prevalence of P. falciparum among 5 - 9-year olds or on that of P. vivax among the 0 - 4- or 5 - 9-year olds A group-r and omized controlled trial of insecticide (permethrin)-treated bed nets ( ITNs ) was conducted in an area of high perennial malaria transmission in western Kenya to test the effect of ITNs on all-cause mortality in children 1 - 59 months of age . Child deaths were monitored over a two-year period by biannual household census in Asembo ( 1997 - 1998 ) and in Gem ( 1998 - 1999 ) . Overall , 1,722 deaths occurred in children 1 - 59 months followed for 35,932 child-years . Crude mortality rates/1,000 child-years were 51.9 versus 43.9 in control and ITN villages in children 1 - 59 months old . The protective efficacy ( PE ) ( 95 % confidence interval ) adjusted for age , study year , study site , and season was 16 % ( 6 - 25 % ) . Corresponding figures in 1 - 11- and 12 - 59-month-old children in control and ITN villages were 133.3 versus 102.3 , PE = 23 % ( 11 - 34 % ) and 31.1 versus 28.7 , PE = 7 % ( -6 - 19 % ) . The numbers of lives saved/1,000 child-years were 8 , 31 , and 2 for the groups 1 - 59 , 1 - 11 , and 12 - 59 months old , respectively . Stratified analysis by time to insecticide re-treatment showed that the PE of ITNs re-treated per study protocol ( every six months ) was 20 % ( 10 - 29 % ) , overall and 26 % ( 12 - 37 % ) and 14 % ( -1 - 26 % ) in 1 - 11- and 12 - 59-month-old children , respectively . ITNs prevent approximately one in four infant deaths in areas of intense perennial malaria transmission , but their efficacy is compromised if re-treatment is delayed beyond six months Spatial analyses of the effect of insecticide (permethrin)-treated bed nets ( ITNs ) on nearby households both with and without ITNs was performed in the context of a large-scale , group-r and omized , controlled mortality trial in Asembo , western Kenya . Results illustrate a protective effect of ITNs on compounds lacking ITNs located within 300 meters of compounds with ITNs for child mortality , moderate anemia , high-density parasitemia , and hemoglobin levels . This community effect on nearby compounds without nets is approximately as strong as the effect observed within villages with ITNs . This implies that in areas with intense malaria transmission with high ITN coverage , the primary effect of insecticide-treated nets is via area-wide effects on the mosquito population and not , as commonly supposed , by simple imposition of a physical barrier protecting individuals from biting . The strength of the community effect depended upon the proportion of nearby compounds with treated nets . To maximize their public health impact , high coverage with treated nets is essential The effectiveness of village-wide use of permethrin-impregnated bed nets or eave , window , and door curtains as control measures for Plasmodium falciparum malaria was evaluated during two successive high-transmission seasons in western Kenya . Pairs of villages were assigned to one of three study groups : bed net , curtain , or control . Clinical , parasitologic , and entomologic measures were made from March to July 1990 and again 12 months later . When compared with the controls in 1990 and 1991 , we observed a marked reduction in the incidence of P. falciparum infections in children less than six years old in the bed net villages ( reduced by 40 % and 48 % ) and a smaller but still significant reduction in the curtain villages ( 10 % and 33 % ) . Significant reductions were also seen in the incidence of P. falciparum parasitemias greater than 2,500/mm3 in the bed net group ( reduced by 44 % and 49 % ) and curtain group ( 16 % and 32 % ) . Additionally , we observed significant reductions in the incidence of documented fevers in association with P. falciparum parasitemia in bed net ( reduced by 63 % ) and curtain villages ( 53 % ) when compared with controls . Entomologic inoculation rates in both bed net and control villages decreased by more than 50 % below control values during both high transmission seasons . The results of this study , together with a 1988 study in the same area during the low transmission season , show that bed nets offer greater year-round of protection against P. falciparum infection than curtains . However , during the high transmission season , this technique reduces the frequency of P. falciparum infection rather than preventing it entirely The efficacy of nets treated with lambda-cyhalothrin , a pyrethroid insecticide , on malaria infection and disease was assessed for the first time at the community level in Anopheles gambiae pyrethroid resistance areas . The study was carried out in northern Côte d'Ivoire , which is an area of kdr resistance . Four pairs of villages were selected and matched according to demographic , sociological , and ecological criteria . Among each pair , a village was r and omly allocated to receive mosquito nets . More than 80 % of beds were covered with nets treated with lambda-cyhalothrin and retreated after 6 months . In each village , 54 children aged 0 - 59 months were r and omly selected and clinical ly monitored for 8 periods of 7 days throughout the year . Results showed that the efficacy of treated nets was maintained with a reduction of the prevalence of asymptomatic malaria infection by 12 % and an estimated protective efficacy against malaria disease of 56 % New tools to prevent malaria morbidity and mortality are needed to improve child survival in sub-Saharan Africa . Insecticide treated bednets ( ITBN ) have been shown , in one setting ( The Gambia , West Africa ) , to reduce childhood mortality . To assess the impact of ITBN on child survival under different epidemiological and cultural conditions we conducted a community r and omized , controlled trial of permethrin treated bednets ( 0.5 g/m2 ) among a rural population on the Kenyan Coast . Between 1991 and 1993 continuous community-based demographic surveillance linked to hospital-based in-patient surveillance identified all mortality and severe malaria morbidity events during a 2-year period among a population of over 11000 children under 5 years of age . In July 1993 , 28 r and omly selected communities were issued ITBN , instructed in their use and
Output:
| REVIEW ERS ' CONCLUSIONS ITNs are highly effective in reducing childhood mortality and morbidity from malaria . |
MS212938 | ***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 study was performed to evaluate the extent to which the medical literature may be misleading as a result of selective publication of r and omized clinical trials ( RCTs ) with results showing a statistically significant treatment effect . Three hundred eighteen authors of published trials were asked whether they had participated in any unpublished RCTs . The 156 respondents reported 271 unpublished and 1041 published trials . Of the 178 completed unpublished RCTs with a trend specified , 26 ( 14 % ) favored the new therapy compared to 423 of 767 ( 55 % ) published reports ( p less than 0.001 ) . For trials that were completed but not published , the major reasons for nonpublication were " negative " results and lack of interest . From the data provided , it appears that nonpublication was primarily a result of failure to write up and su bmi t the trial results rather than rejection of su bmi tted manuscripts . The results of this study imply the existence of a publication bias of importance both to meta- analysis and the interpretation of statistically significant positive trials A double-blind study was carried out in 30 patients suffering from spasticity due to cerebrovascular lesions to compare the long-term efficacy and tolerability of tizanidine hydrochloride with that of baclofen . A 2-week titration phase identified the optimum dose of tizanidine ( max . 20 mg/day ) or baclofen ( max . 50 mg/day ) in each patient . Patients were then treated with this dose for a 50-week maintenance phase . Efficacy and tolerability parameters were evaluated first on a monthly and then on a bimonthly basis . Both tizanidine and baclofen caused an improvement in the symptoms associated with spasticity . In end-point analysis , 87 % of patients showed an improvement ( p less than 0.01 ) in excessive muscle tone - the major efficacy parameter in this study - in the tizanidine group , while 79 % improved ( p less than 0.01 ) in the baclofen group . Side-effects in the tizanidine group were mild and transient and no patients discontinued the study ; in the baclofen group , 3 patients discontinued the study due to severe side-effects . However , both drugs were assessed as effective and fairly well tolerated in the long-term . Although there were no statistically significant differences between the two drugs , the global assessment of antispastic efficacy revealed a nearly significant difference ( p = 0.057 ) in favour of tizanidine and the global assessment of tolerability was also in favour of tizanidine A study was carried out to determine the efficacy and long-term safety of dantrolene in treating stroke patients with spasticity limiting rehabilitation . Fifteen of the 18 patients studied experienced reduction in spasticity and clinical improvement after treatment with dantrolene sodium for 6 weeks . Fourteen of these patients participated in a 6-week , double-blind , placebo-controlled study . The 5 patients who continued to receive dantrolene did not experience clinical deterioration . However , the 9 patients given placebo noted increased deficits . Seven asked that the blind be broken and chose to resume dantrolene therapy . After 6 weeks , 13 of the 14 patients elected to continue on dantrolene ( average dose 165.4 mg/day ) . All continued to improve . Side-effects were generally mild and transient . Although these patients took other drugs concomitantly , no drug interactions were reported A double-blind , placebo-controlled trial was conducted to determine whether early exhibition of Dantrium ( Dantrolene Sodium ) in patients with cerebrovascular accidents , before the onset of significant spasticity , would enhance the functional outcome of rehabilitation . Thirty-eight patients were enrolled in the trial and 31 satisfactorily completed the study . A modified Cybex isokinetic dynamometer was used to gather information on strength and muscle tone . Clinical , functional , and biochemical data were also collected . It was found that Dantrium reduced strength in the unaffected limbs but did not alter strength in the paretic limbs . Dantrium produced no alteration in clinical tone , functional outcome , or biochemical tests at the dosage ( 200 mg per day ) used in this study A double-blind study was carried out in 105 patients with chronic spasticity associated with hemiplegia in order to compare the efficacy and tolerability of tizanidine with that of diazepam . Dosage was increased progressively , if tolerated , to a maximum of 24 mg tizanidine or 30 mg diazepam per day at the end of 2 weeks . The optimum dosage was then maintained for 6 weeks . Efficacy and tolerability parameters were assessed after 2 and 8-weeks ' therapy . Patients on tizanidine but not those on diazepam showed a statistically significant improvement in functional status , as assessed by walking distance on flat ground . Analysis of the stretch reflex in four groups of muscles showed that both tizanidine and diazepam reduced the duration of contractions and increased the angle at which contraction occurred , but there were no significant differences between the two drugs . Clonus of the triceps surae resolved in 48 % of tizanidine and 40 % of diazepam patients . Evaluation of the effect of therapy revealed an improvement with each drug in approximately 83 % of patients , with the overall evaluation being slightly ( but non-significantly ) in favour of tizanidine . There were fewer discontinuations of treatment in the tizanidine group as a result of side-effects . It would appear , therefore , that tizanidine is an effective and well-tolerated drug in the treatment of cerebral spasticity Our serendipitous observations suggested that some patients with spasticity appeared to have improved following the administration of the anticonvulsant drug gabapentin . As some patients with spasticity are either refractory to or intolerant of established medical treatments , we conducted this study to investigate the effect of gabapentin on spasticity in patients with spinal cord injury . Twenty-five patients with spinal cord injury and spasticity received oral gabapentin ( 2400 mg over 48 h ) in a r and omized , double blind , placebo-controlled crossover study . We assessed responses by measuring the Ashworth spasticity scale , muscle stretch reflexes , presence of clonus and reflex response to noxious stimuli . Patient ratings were obtained using a Likert Scale . Administration of gabapentin , but not placebo , was associated with an 11 % reduction in spasticity as measured by the Ashworth Scale ( P=0.04 ) and by a 20 % reduction in the Likert Scale ( P=0.0013 ) . Significant changes were not obtained for the other measures . The data obtained suggest that gabapentin may be useful in the management of spasticity associated with spinal cord injury OBJECTIVE To determine if orally delivered tizanidine will control spastic hypertonia due to acquired brain injury . DESIGN R and omized , double-blind , placebo-controlled , crossover design , with 2 8-week treatment arms separated by a 1-week washout period at baseline . Patients were r and omly assigned to receive tizanidine or a matching placebo . SETTING Tertiary care outpatient and inpatient rehabilitation center attached to a university hospital . PARTICIPANTS Seventeen persons recruited in a consecutive manner , 9 of whom had suffered a stroke and 8 a traumatic brain injury , and had more than 6 months of intractable spastic hypertonia . INTERVENTION Over a 6-week period , subjects were slowly titrated up to their maximum tolerated dose ( up to 36 mg/d ) . Following a 1-week drug taper and 1-week period in which no study drug was administered , patients were then crossed over to the other study medication following an identical titration regime . MAIN OUTCOME MEASURES Subjects were evaluated for dose and effect throughout the trial as well as for side effects . Data for Ashworth rigidity scores , spasm scores , deep tendon reflex scores , and motor strength were collected on the affected upper extremity ( UE ) and lower extremity ( LE ) . Differences over time were assessed via descriptive statistics , Friedman 's analysis , and Wilcoxon 's signed-rank . Data are reported as the mean + /- 1 st and ard deviation . RESULTS Following 4 weeks of treatment when subjects reached their maximal tolerated dosage , the average LE Ashworth score on the affected side decreased from 2.3 + /- 1.4 to 1.7 + /- 1.1 ( p < .0001 ) . The spasm score decreased from 1.0 + /- 0.9 to 0.5 + /- 0.8 ( p = .0464 ) , while the reflex score was not statistically significant decreasing from 2.2 + /- 1.0 to 2.0 + /- 1.1 ( p = .0883 ) . The average UE Ashworth score on the affected side decreased from 1.9 + /- 1.1 to 1.5 + /- 0.9 ( p < .0001 ) . There was no significant change in the UE spasm and reflex scores . While there were positive placebo effects on motor tone , the active drug was still significantly better than placebo for decreasing LE tone ( p = .0006 ) and UE tone ( p = .0007 ) . With a reduction in motor tone , there was an increase in motor strength ( p = .0089 ) . The average dosage at 4 weeks was 25.2mg/d . CONCLUSION Tizanidine is effective in decreasing the spastic hypertonia associated with acquired brain injury , which is dose-dependent . There are limitations on its use due to side effects related to drowsiness A double-blind study was carried out on 20 children with spasticity secondary to cerebral palsy , in order to compare the effects of dantrolene sodium suspension and a placebo . The drug was found to be physiologically active in reducing the force of muscle contraction , but objective functional improvement , as measured by multiple performance tests , was irregular and probably not significant A double-blind crossover trial against placebo was conducted to assess the effects of the GABA derivative , baclofen , on the disabilities due to muscle spasticity in twenty children suffering from cerebral palsy . Baclofen performed very significantly better than placebo in reducing spasticity and significantly better than placebo in allowing both active and passive limb movements to be carried out . Notable improvement was also seen in scissoring . Side-effects were minimal and responded promptly to dose reduction . The evaluation of drug effects on muscle spasticity and the pharmacodynamics of baclofen are discussed . Recommendations are made regarding dosage of baclofen in childhood A double blind cross-over trial of Valium against Amytal and Placebo was carried out on 22 patients with spasticity due to spinal cord injuries . Observations were made by six independent observers . Valium was significantly more effective than Amytal or Placebo . There was a low incidence of side-effects
Output:
| Conclusion : Evidence on the efficacy of oral antispastic drugs in NPND is weak and does not include evaluation of patients ’ quality of life .
If any , efficacy is marginal .
Adverse drug reactions were common . |
MS212939 | ***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 the present study was to determine whether the vaginal preparation with povidone – iodine prior to caesarean delivery decreased the incidence of postpartum endometritis . Methods : The present study was a prospect i ve r and omized controlled trial in which subjects received a vaginal preparation with povidone – iodine solution immediately prior to caesarean delivery or received no vaginal preparation . The primary outcome measure was the rate of postpartum endometritis . Results : A significant decrease in post-caesarean endometritis was noted in the group that received the povidone – iodine vaginal preparation ( n = 334 ) compared with the control group ( n = 336 ) [ 6.9 vs. 11.6 % ; RR = 1.69 ; 95 % CI = 1.03–2.76 ] . No statistically significant differences in the incidence of endometritis were noted between the experimental and control groups among women who were not in labor at the time of the caesarean delivery [ 9.2 vs. 8.6 % ; RR = 1.05 ; 95 % CI = 0.58–1.90 ] , and no differences were found between groups when women with ruptured membranes were excluded from the analysis [ 9.6 vs. 6.7 % ; RR = 1.39 ; 95 % CI = 0.78–2.47 ] . Conclusions : Vaginal preparation with povidone – iodine solution immediately prior to a caesarean delivery reduces the risk of post-operative endometritis . This preemptive measure was only found to be beneficial in women whose membranes had ruptured and those who were in labor prior to caesarean surgery Objectives : To determine the carriage rate of enterococcus in the lower genital tract of women having a cesarean delivery and to determine whether a single 2-g intraoperative dose of ampicillin eradicates enterococcus from the lower genital tract . Methods : Lower genital tract cultures were taken in 84 women who were in labor or had ruptured membranes and who were about to have an indicated cesarean delivery . The subjects were r and omized to receive either a single 2-g dose of ampicillin or a cephalosporin as prophylaxis . Cultures were repeated 24 hours postpartum . Results : Enterococcus was isolated preoperatively in 33 subjects ( 39.3 % ) and postoperatively in 36 ( 42.9 % ) . The enterococcus was eradicated in five of 17 women ( 29.5 % ) who received ampicillin . Conclusion : These results suggest that a single 2-g dose of ampicillin does not eradicate enterococcus from the lower genital tract . ( Obstet Gynecol 1993;81:115 - 7 Abstract Objective : To evaluate the efficacy of preoperative vaginal cleansing using chlorhexidine 0.25 % antiseptic wipes on rates of postcesarean section ( CS ) infectious morbidities ( endometritis , febrile morbidity and wound infection ) . Methods : This prospect i ve r and omized trial was conducted among 218 pregnant women scheduled for term elective CS . Patients were equally divided into two groups by simple r and omization . After spinal anesthesia and catheterization under aseptic technique , the study group had preoperative vaginal cleansing using chlorhexidine 0.25 % antiseptic wipes for about 1 min , while the control group did not . All cases received the prophylactic antibiotics and the usual abdominal scrub . All participants received the routine postoperative care without other interventions . Adverse postcesarean infectious morbidities such as endometritis , febrile morbidity and wound infection were observed at the time of hospital discharge and weekly for 6 weeks postpartum . Results : Both groups were matched regarding the baseline patients ’ characteristics ( age , gestational age , BMI , operative time and postoperative hospital stay ) . Overall , post-CS infectious morbidity were significantly reduced from 24.4 % in the control group to 8.8 % in the intervention group ; p value < 0.05 . Marked reduction was seen in the incidence of endometritis ( 13.2 % in the control group versus 2.9 % in the intervention group ; p value < 0.05 ) . However , fever and wound infection showed no significant difference between both groups . Conclusion : Cleansing the birth canal with chlorhexidine 0.25 % wipes prior to elective CS appears to be effective in reducing rates of post-CS infectious morbidity mainly endometritis Abstract Objective : To assess the effect of povidone iodine versus benzalkonium chloride , which were applied preoperatively for vaginal disinfection in caesarean sections , on postoperative factors . Methods : One hundred and twenty patients underwent elective caesarean section were divided into three groups using the simple r and omisation method : Group 1 ( povidone iodine , n : 41 ) ; Group 2 ( benzalkonium chloride , n : 39 ) ; Group 3 ( control group , n : 40 ) . Demographic data , duration of operation , amount of bleeding , postoperative pain , time to first flatulence and defaecation , haematological parameters on postoperative day 1 were compared between three groups . Pain evaluation was performed at 6th and 24th postoperative hour using Visual Analogue Scale . Results : No statistically significant differences were detected between the groups in demographic characteristics . There were no significant differences between the groups with respect to the duration of operation and hospital stay . The patients in the group who underwent povidone iodine vaginal cleansing had statistically significantly less postoperative pain as compared to control group . No difference was observed between the groups in haematological parameters other than C-reactive protein ( CRP ) ; however , CRP levels at 24th post-operative hour were significantly lower in Group 1 compared to the other groups . Conclusions : The preoperative vaginal cleansing with povidone iodine could reduce the postoperative pain , analgesic need and infection parameter The introduction of antibiotic prophylaxis for cesarean delivery has decreased the risk of postpartum endometritis and wound infection , but factors that contribute to prophylaxis failure are not understood . To determine factors that might contribute to postpartum infections following antibiotic prophylaxis , we cultured amniotic fluid , decidua , and chorioamniotic membrane specimens for anaerobic and facultative bacteria and for genital mycoplasmas at cesarean delivery . Women were assessed daily for the development of infections , and if endometritis developed , a protected endometrial culture was obtained . Postpartum endometritis developed in 16 and wound infection in four of 102 women . Infection rates were similar for women receiving cefotetan ( N=50 ) or cefoxitin ( N=52 ) for prophylaxis . The isolation of group B streptococcus { P<.001 ) or Enterococcus faecalis { P=.03 ) from the upper genital tract at delivery was significantly associated with postpartum endometritis . Antibiotic- resistant organisms ( other than enterococci ) were recovered uncommonly at delivery or with postpartum infections . Group B streptococcus was susceptible to the prophylactic agents used , suggesting that virulence factors other than antibiotic resistance are important for the development of postpartum endometritis . Group B streptococcus , E faecalis , and bacteria associated with bacterial vaginosis were recovered from the endometrium at the time of postpartum endometritis OBJECTIVE Our purpose was to determine whether chlorhexidine vaginal irrigation prevents maternal peripartal infection . STUDY DESIGN A double-blinded , placebo-controlled , r and omized trial was performed . Single 200 ml irrigations of either 0.2 % chlorhexidine solution or sterile water placebo were given in active labor or before planned cesarean delivery . The primary outcome measure was the combined rate of chorioamnionitis and endometritis ( which were mutually exclusive diagnoses ) . RESULTS A total of 1024 patients were enrolled : 508 in the chlorhexidine group and 516 in the placebo group . The two groups were generally well balanced on important clinical factors but differed ( p < 0.05 ) in rates of nulliparity ( chlorhexidine 42 % , placebo 52 % ) , intrauterine pressure catheter usage ( chlorhexidine 65 % , placebo 72 % ) , and presence of meconium ( chlorhexidine 17 % , placebo 22 % ) . There were no recognized adverse maternal or neonatal reactions to irrigation . Rates of infection ( chorioamnionitis + endometritis ) did not differ significantly between the groups , chlorhexidine 10 % versus placebo 13 % ( relative risk 0.8 , 95 % confidence interval 0.5 to 1.1 ) . Stratified and logistic regression analyses supported the primary univariate analysis . Neonatal outcomes , including sepsis rates of 0.4 % , were equivalent for the groups . CONCLUSION As used in this trial , chlorhexidine lacked efficacy in the prevention of maternal peripartal infection BACKGROUND We found cesarean section ( C-section ) surgical site infection ( SSI ) at our institution was significantly higher than the national benchmark . METHODS A retrospective cohort study was conducted under 4 phases from January 2008-December 2014 . The hospital infection control ( IC ) policies and a presurgical checklist were bundled and implemented . The study was conducted with 3,334 cesarean deliveries : phase A ( January 1 , 2008-January 31,2010 ) : 1,250 patients without intervention ( baseline SSI rate ) , phase B ( February 1 , 2010-July 31 , 2011 ) : 682 patients were intervened with IC policies , phase C ( August 1 , 2011-December 31 , 2012 ) : 591 patients with an SSI reduction bundle , and phase D ( January 1 , 2013-December 31 , 2014 ) : 811 patients were monitored for C-section SSI sustainability . Patients not following strict protocol s because of emergency C-section deliveries were excluded . The χ2 test , Fisher exact test , and st and ard Z test were used for statistical analyses . RESULTS C-section SSI rates were 6.2 % ( 77/1,250 ) in phase A , 3.7 % ( 25/682 ) in phase B , 1.7 % ( 10/591 ) in phase C , and 0.1 % ( 1/811 ) in phase D , respectively . By implementing the IC policies and bundle , the C-section SSI rate was reduced 40.3 % ( phase B vs phase A ) , 72.6 % ( phase C vs phase A ) , and 98.4 % ( phase D vs phase A ) . All statistics were significantly different . CONCLUSIONS We conclude that implementing a C-section SSI reduction bundle was associated with reduced C-section SSI rate down toward zero . A future prospect ively r and omized controlled trial is warranted OBJECTIVE The objective of the study was to determine whether vaginal preparation with povidone iodine before cesarean delivery decreased the risk of postoperative maternal morbidities . STUDY DESIGN The design of the study was a r and omized , controlled trial in women undergoing cesarean delivery with subjects assigned to have a preoperative vaginal cleansing with povidone iodine or to a st and ard care group ( no vaginal wash ) . The primary outcome was a composite of postoperative fever , endometritis , sepsis , readmission , wound infection , or complication . RESULTS There were 155 vaginal cleansing subjects and 145 control subjects . Overall , 9.0 % developed the composite outcome , with fewer women in the cleansing group ( 6.5 % ) compared with the control group ( 11.7 % ) , although the difference was not statistically significant ( relative risk , 0.55 ; 95 % confidence interval , 0.26 - 1.11 ; P = .11 ) . Length of surgery , being in labor , and having a dilated cervix were all associated with the composite morbidity outcome . CONCLUSION Vaginal cleansing with povidone iodine before cesarean delivery may decrease postoperative morbidities , although the reduction is not statistically significant OBJECTIVE To estimate the efficacy of preoperative administration of intravaginal metronidazole for the prevention of postcesarean endometritis . METHODS This double‐masked , placebo‐controlled r and omized trial included patients of at least 24 weeks ' gestation undergoing cesarean deliveries for various indications . Patients were r and omized to receive either 5 g of metronidazole gel intravaginally or matching placebo before the initiation of the cesarean . All patients underwent surgical cleansing of the abdomen , and most received prophylactic antibiotics after cord clamping . Patients with chorioamnionitis and /or suspected allergy to metronidazole were excluded . For a two‐sided α of 0.05 and β of 0.20 ( 80 % power ) , 120 subjects were required in each group . The main outcome variable was the incidence of postcesarean endometritis . Secondary outcome variables included presence of febrile morbidity , wound infection , days on antibiotics , and length of postpartum hospitalization . Neonatal outcomes included birth weight
Output:
| No adverse effects were reported with either the povidone-iodine or chlorhexidine vaginal cleansing .
AUTHORS ' CONCLUSIONS Vaginal preparation with povidone-iodine or chlorhexidine solution compared to saline or not cleansing immediately before cesarean delivery probably reduces the risk of post-cesarean endometritis .
Subgroup analysis could not rule out larger reductions in endometritis with antiseptics in women who were in labor or in women whose membranes had ruptured when antiseptics were used . |
MS212940 | ***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 prospect ively studied the management and outcome of 2,834 children , aged 1 month to 18 years , who presented to the emergency department of the Children 's Hospital of Philadelphia for laceration repair . Patients with bite wounds were excluded from the study . Eight percent ( 239 ) of all patients had complications on initial evaluation ; the most common was the presence of a foreign body ( 55 ) . Infection on presentation was diagnosed in 22 cases ( 0.8 % ) . All of these patients had delayed their initial care beyond 18 hours ( range , 18 to 288 hours ; mean , 18 hours ) . Other factors significantly associated with infection on presentation included occurrence of the injury outdoors ( 16 ; P less than .001 ) , injury due to broken " street " glass ( seven ; P less than .02 ) , and injury of an extremity ( 18 ; P less than .01 ) . The rate of prerepair infection was not influenced by the size of the wound . Infections developed subsequent to initial repair in 34 cases ( 1.2 % ) . Factors associated with development of subsequent infection included use of prophylactic antibiotics , use of subcutaneous sutures , laceration length of more than 5.0 cm , glass or ice as a causative agent , and upper- or lower-extremity involvement . The majority of injuries were repaired by ED personnel without surgical consultation . Postrepair infection rates were not influenced by the specialty of the physician managing the case . Although our study was not design ed to specifically test the issue , prophylactic antibiotics were of no proven benefit in reducing infection rates in any group of patients analyzed STUDY OBJECTIVE More than 11 million patients with traumatic wounds are seen annually in emergency departments . We developed and vali date d a data registry for traumatic wounds treated in the ED . DESIGN Prospect i ve , consecutive patient enrollment with a validation cohort of a convenience sample of 100 patients . SETTING University-affiliated hospital ED . PARTICIPANTS For all patients with traumatic wounds requiring sutures , wound registry data sheets were completed at the time of initial visit using a closed- question format . Data recorded included demographic characteristics , time from injury to evaluation , pertinent medical history , wound characteristics , type of anesthesia , details of wound-cleansing methods , details of wound closure , and postoperative care . We devised a follow-up tool to evaluate for the presence of infection and short-term cosmetic appearance . Interphysician reliability was assessed for wound description , presence of infection , and cosmetic appearance by use of the kappa statistic . RESULTS A wound registry data collection instrument that takes less than 1 minute to complete and enables the collection of most wound management techniques used by emergency physicians was found to have substantial interobserver concordance for wound description ( kappa range , .55 to .97 ) , wound infection ( kappa = 1.0 ) and overall cosmetic appearance ( kappa = .61 ) . CONCLUSION The wound registry is a reliable data collection instrument that is easy to use . It may be useful as a continuous quality -improvement tool or for st and ardization of wound surveillance and treatment data to facilitate future prospect i ve studies in wound management In wounds of the h and and forearm treated within 4 h of injury , prophylactic clindamycin , in a dose of 150 mg 6‐hourly for 5 days , did not reduce the infection rate . In wounds treated after 4 h the infection rate was reduced , but not significantly so . There was a significant reduction in the infection rate comparing all wounds treated within 4 h with those treated after 4 h. Early treatment of wounds is more important than prophylactic antibiotics , although these may have a part to play where late treatment is unavoidable Introduction Primary wound closure in the management of open tibial fractures has generally been discouraged . Several prior studies suggest that infections are not caused by the initial contamination , but are instead the result of organisms acquired in the hospital . Primary wound closure after adequate wound care and fracture stabilisation could therefore be considered a reasonable option . Material s and methods We analysed 95 patients with open tibial fractures ( Gustilo– And erson type 1 to 3A ) treated with primary fracture stabilisation and either delayed wound closure ( group I ) or primary wound closure ( group II ) , with a minimum follow-up of 12 months . Results Group I included 46 patients with a mean age of 30.2 years ( 16–56 ) , and a mean follow-up of 13.5 months ( 12–18 ) . Group II included 49 patients with a mean age of 33.4 ( 18–69 ) , and a mean follow up of 13.7 months ( 12–16 ) . One infection developed in group I ( 2 % ) , and two infections developed in group II ( 4 % ) . This difference was not found to have any statistical significance . Conclusion Our results support other recent reports that the infection rate is not increased following primary wound closure after thorough debridement of less severe open fractures . The length of stay following primary closure ( group II ) was significantly shorter , and that should result in substantially more cost effective care of these serious injuries . We conclude that primary wound closure is a safe option in properly selected cases . Prospect i ve multi-centre studies are needed to further evaluate the safety and efficacy of this treatment alternative Uncertainty about the existence and duration of a " golden period " for suture repair of simple wounds led us to evaluate prospect ively the consequences of delayed primary closure on wound healing . Wounds were eligible for study if they were not grossly infected , and had no associated injuries to nerves , blood vessels , tendons , or bone . Three hundred seventy-two patients underwent suture repair ; 204 ( 54.8 % ) returned for review seven days later . The mean time from wounding to repair for all patients was 24.2 + /- 18.8 hours . Wounds closed at up to 19 hours after wounding had a significantly higher rate of healing than those closed later : 82 of 89 ( 92.1 % ) compared with 89 of 115 ( 77.4 % ) ( P less than .01 ) . Of 23 wounds sutured 48 or more hours ( mean , 65.3 ) after wounding , 18 ( 78.3 % ) were healing at follow-up . In contrast to wounds involving other body areas , the healing of head wounds was virtually independent of time from injury to repair : 42 of 44 ( 95.5 % ) wounds involving the head and repaired later than 19 hours after injury were healing , compared with 47 of 71 ( 66.2 % ) of all other wounds ( P less than .001 ) . On the basis of these data we conclude that there is a 19-hour " golden period " for repair of simple wounds involving body areas other than the head , after which sutured wounds are significantly less likely to heal , and the healing of clean , simple wounds involving the head is unaffected by the interval between injury and repair BACKGROUND / AIMS To compare two non-invasive techniques of assessing wound healing , photography and high resolution ultrasound ( HRUS ) scanning , in experimentally induced full-thickness human skin wounds . METHODS Punch biopsy wounds , 4 mm in diameter , were made aseptically through locally anaesthetised skin on the anterior ( volar ) surface of the non-dominant forearm , 3 cm below the base of the cubital fossa , of 20 human participants . The wounds were treated with a topical antibiotic and covered for 3 days with Mepore sterile dressings . Wound healing was assessed on post-operative days 3 , 7 , 14 and 21 from photographs and HRUS B-scans . All photographs were taken of the wound site and adjacent intact skin under st and ardised conditions . The prints obtained were examined visually and digitised . Digital HRUS B-scans were taken through the centre of the wound bed and the adjacent intact skin parallel to the epidermis . Using the scanner 's calibrated linear measurement capability , the wound width was measured adjacent to the deep surface of the scab , at the base of the wound , and midway between these two levels . RESULTS The wound margins were more clearly defined in the HRUS scans than in the photographs of the wounds ; in some of the latter the scab masked the wound margins . Changes in the surface width of the wound were affected by the time of scab dehiscence , which varied between volunteers . There was less individual variation in the width of the base of the wound , as measured from the HRUS scans . CONCLUSIONS In contrast to photography , which allows recording of changes in the superficial aspect of the wound only , HRUS scanning permits the quantitative assessment of structural changes deep within the wound . Temporal changes in the width of the base of the wound can be used as an indication of the progress of repair
Output:
| There is currently no systematic evidence to guide clinical decision-making regarding the timing for closure of traumatic wounds . |
MS212941 | ***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 aim of the present study was to evaluate the cost-effectiveness of tailored print communication ( TPC ) , telephone motivational interviewing ( TMI ) , a combination of the two , and no intervention on two outcomes in adults aged 45 to 70 , half of them having hypertension : increasing the number of public health guidelines met for three behaviors ( physical activity and fruit and vegetable consumption ) , and impact on quality adjusted life years ( QALYs ) . Methods Participants ( n = 1,629 ) from 23 Dutch general practice s were r and omized into one of four groups , which received 4 TPCs , 4 TMIs , 2 of each ( combined ) , or no intervention ( control ) , respectively . The self-reported outcomes , measured at baseline and 73 weeks follow-up ( 7 months after the last intervention component ) , were difference in total number of guidelines met at follow-up compared to baseline , and number of QALYs experienced over 73 weeks . The costs of implementing the intervention were estimated using a bottom-up approach . Results At 73 weeks follow-up participants showed increased adherence with 0.62 ( TPC ) , 0.40 ( TMI ) , 0.50 ( combined ) , and 0.26 ( control ) guidelines compared to baseline , and experienced 1.09 , 1.08 , 1.08 , and 1.07 QALYs , respectively . The costs for the control group were considered to be zero . TMI was more expensive ( € 107 per person ) than both the combined intervention ( € 80 ) and TPC ( € 57 ) . The control condition was most cost-effective for lower ceiling ratios , while TPC had the highest probability of being most cost-effective for higher ceiling ratios ( more than € 160 per additional guideline met , and € 2,851 for each individual QALY ) . Conclusions For low society 's willingness to pay , the control group was most cost-effective for the number of QALYs experienced over 73 weeks . This also applied to the increase in the number of guidelines met at lower ceiling ratios , whereas at higher ceiling ratios , TPC had a higher probability of being more cost-effective than the TMI , combined or control conditions . This also seemed to apply for QALYs experienced over 73 weeks . More research is needed on the long-term efficacy of both TPC and TMI , as well as on how to increase their cost-effectiveness . Trial registration Dutch Trial Register Background Non-adherence to antihypertensive drugs is high , and the economic consequences of non-adherence may be substantial . The Medication Events Monitoring System ( MEMS ) , which is a method to improve adherence , has been shown to be a useful tool for the management of adherence problems . Objective To assess the cost effectiveness of the MEMS compared with usual care in a population of hypertensive patients with poor adherence . The MEMS programme consisted of provision of containers fitted with electronic caps together with adherence training if indicated . Methods In a r and omised controlled trial , 164 hypertensive patients in the experimental strategy and 89 patients in the usual care strategy were followed for 5 months . Patients who had a systolic blood pressure ( SBP ) ≥160 mm Hg and /or diastolic BP ( DBP ) ≥95 mm Hg despite the use of antihypertensive drugs were eligible . Patients were recruited by a GP , and treatment took place in general practice .In the experimental strategy , electronic monitoring of the intake of antihypertensive drugs was introduced without change of medication . Unsatisfactory adherence was defined as < 85 % of days with the number of doses taken as prescribed . In the usual care strategy , antihypertensive treatment was intensified by the addition or change of antihypertensive drugs , if necessary , without provision of an electronic monitor . Outcome parameters included the proportion of patients with normalised blood pressure ( NBP ) at 5 months and QALYs . Costs were quantified from the healthcare and societal perspective . Non-parametric bootstrap simulations were per formed to quantify the uncertainty around the mean estimates and cost-effectiveness acceptability curves were presented . In addition , a number of univariate sensitivity analyses were performed on deterministic variables . Results At 5 months , 3.1 % ( 95 % UI [ uncertainty interval ] −9.7 % , + 15.8 % ) more patients had NBP , and 0.003 ( 95 % UI −0.005 , + 0.010 ) more QALYs were generated in the experimental strategy . A statistically significant lower percentage of patients had a dose escalation in the experimental strategy . Irrespective of the ceiling ratio for cost effectiveness , the cost-effectiveness probability was between 75 % and 80 % for the analysis from the healthcare perspective using proportion of patients with NBP as the outcome parameter . For the analysis from the societal perspective using QALYs as the outcome parameter , this probability was between 45 % and 51 % . Conclusion For a time horizon of 5 months , a difference in both cost and effect could not be detected between an adherence-improving programme compared with usual care for hypertensive patients . The probability that the adherence-improving programme is cost effective is at best moderate . Moreover , the costeffectiveness result is surrounded with considerable uncertainty and large-scale implementation warrants additional research into the economic consequences of this intervention . Patients may benefit from the use of a MEMS monitor in situations where BP targets are not reached because of suspected non-adherence and both patient and GP are reluctant to increase the dose or number of antihypertensive drugs Background Non-adherence to anti-psychotics is common , expensive and affects recovery . We therefore examine the cost-effectiveness of adherence therapy for people with schizophrenia by multi-centre r and omised trial in Amsterdam , London , Leipzig and Verona . Methods Participants received 8 sessions of adherence therapy or health education . We measured lost productivity and use of health/social care , criminal justice system and informal care at baseline and one year to estimate and compare mean total costs from health/social care and societal perspectives . Outcomes were the Short Form 36 ( SF-36 ) mental component score ( MCS ) and quality -adjusted life years ( QALYs ) gained ( SF-36 and EuroQoL 5 dimension ( EQ5D ) ) . Cost-effectiveness was examined for all cost and outcome combinations using cost-effectiveness acceptability curves ( CEACs ) . Results 409 participants were recruited . There were no cost or outcome differences between adherence therapy and health education . The probability of adherence therapy being cost-effective compared to health education was between 0.3 and 0.6 for the six cost- outcome combinations at the willingness to pay thresholds we examined . Conclusions Adherence therapy appears equivalent to health education . It is unclear whether it would have performed differently against a treatment as usual control , whether such an intervention can impact on quality of life in the short-term , or whether it is likely to be cost-effective in some sites but not others . Trial registration Trial registration : Current Controlled TrialsIS RCT Background High levels of adherence to medications for HIV infection are essential for optimal clinical outcomes and to reduce viral transmission , but many patients do not achieve required levels . Clinician-delivered interventions can improve patients ’ adherence , but usually require substantial effort by trained individuals and may not be widely available . Computer-delivered interventions can address this problem by reducing required staff time for delivery and by making the interventions widely available via the Internet . We previously developed a computer-delivered intervention design ed to improve patients ’ level of health literacy as a strategy to improve their HIV medication adherence . The intervention was shown to increase patients ’ adherence , but it was not clear that the benefits result ing from the increase in adherence could justify the costs of developing and deploying the intervention . The purpose of this study was to evaluate the relation of development and deployment costs to the effectiveness of the intervention . Methods Costs of intervention development were drawn from accounting reports for the grant under which its development was supported , adjusted for costs primarily result ing from the project ’s research purpose . Effectiveness of the intervention was drawn from results of the parent study . The relation of the intervention ’s effects to changes in health status , expressed as utilities , was also evaluated in order to assess the net cost of the intervention in terms of quality adjusted life years ( QALYs ) . Sensitivity analyses evaluated ranges of possible intervention effectiveness and duration s of its effects , and costs were evaluated over several deployment scenarios . Results The intervention ’s cost effectiveness depends largely on the number of persons using it and the duration of its effectiveness . Even with modest effects for a small number of patients the intervention was associated with net cost savings in some scenarios and for duration s greater than three months and longer it was usually associated with a favorable cost per QALY . For intermediate and larger assumed effects and longer duration s of intervention effectiveness , the intervention was associated with net cost savings . Conclusions Computer-delivered adherence interventions may be a cost-effective strategy to improve adherence in persons treated for HIV.Trial registration Clinical trials.gov identifier NCT01304186 BACKGROUND Comprehensive geriatric assessment ( CGA ) can be effective in inpatient units , but such inpatient setting s are prohibitively expensive . If similar benefits could be obtained in outpatient setting s , CGA might be a more attractive option . OBJECTIVES To assess the cost-effectiveness ( CE ) of an outpatient geriatric assessment with an intervention to increase adherence . SUBJECTS Three hundred fifty-one community-dwelling , elderly subjects with at least one of four geriatric conditions . MEASURES In addition to the measures of functioning , we collected data on the costs of the intervention itself and on the use of medical services in the 64 weeks after the intervention . RESULTS The intervention , which prevented functional decline , cost $ 273 per participant . The intervention group averaged three more visits than the control group in the first 32 weeks after the intervention , but only 1.2 extra visits in the next 32 weeks . We estimate that the costs of these additional medical services would be $ 473 for the 5 years after the intervention , leading to a total cost per Quality Adjusted Life Year ( QALY ) of $ 10,600 . CONCLUSIONS The CE of this program compares favorably with many common medical interventions . Whether investments should be made in health care re sources on treatments that lead to modest improvements in the functioning of community-dwelling elderly people remains a societal decision Background Non-adherence to antidepressants generates higher costs for the treatment of depression . Little is known about the cost-effectiveness of pharmacist 's interventions aim ed at improving adherence to antidepressants . The study aim ed to evaluate the cost-effectiveness of a community pharmacist intervention in comparison with usual care in depressed patients initiating treatment with antidepressants in primary care . Methods Patients were recruited by general practitioners and r and omized to community pharmacist intervention ( 87 ) that received an educational intervention and usual care ( 92 ) . Adherence to antidepressants , clinical symptoms , Quality -Adjusted Life-Years ( QALYs ) , use of healthcare services and productivity losses were measured at baseline , 3 and 6 months . Results There were no significant differences between groups in costs or effects . From a societal perspective , the incremental cost-effectiveness ratio ( ICER ) for the community pharmacist intervention compared with usual care was € 1,866 for extra adherent patient and € 9,872 per extra QALY . In terms of remission of depressive symptoms , the usual care dominated the community pharmacist intervention . If willingness to pay ( WTP ) is € 30,000 per extra adherent patient , remission of symptoms or QALYs , the probability of the community pharmacist intervention being cost-effective was 0.71 , 0.46 and 0.75 , respectively ( societal perspective ) . From a healthcare perspective , the probability of the community pharmacist intervention being cost-effective in terms of adherence , QALYs and remission was of 0.71 , 0.76 and 0.46 , respectively , if WTP is € 30,000 . Conclusion A brief community pharmacist intervention addressed to depressed patients initiating antidepressant treatment showed a probability of being cost-effective of 0.71 and 0.75 in terms of improvement of adherence and QALYs , respectively , when compared to usual care . Regular implementation of the community pharmacist intervention is not recommended . Trial Registration Clinical Trials.gov Background Smoking prevalence is high among Pakistani and Bangladeshi men in the UK , but there are few tailored smoking cessation programmes for Pakistani and Bangladeshi communities . The aim of this study was to pilot a cluster r and omised controlled trial comparing the effectiveness of Pakistani and Bangladeshi smoking cessation outreach workers with st and ard care to improve access to and the success of English smoking cessation services . Methods A pilot cluster r and omised controlled trial was conducted in Birmingham , UK . Geographical lower layer super output areas were used to identify natural communities where more than 10 % of the population were of Pakistani and Bangladeshi origin . 16 agglomerations of super output areas were r and omised to normal care controls vs. outreach intervention . The number of people setting quit date s using NHS services , vali date d abstinence from smoking at four weeks , and stated abstinence at three and six months were assessed . The impact of the intervention on choice and adherence to treatments , attendance at clinic appointments and patient satisfaction were also assessed . Results We were able to r and omise geographical areas and deliver the outreach worker-based services . More Pakistani and Bangladeshi men made quit attempts with NHS services in intervention areas compared with control areas , rate ratio ( RR ) 1.32 ( 95%CI : 1.03 - 1.69 ) . There was a small increase in the number of 4-week abstinent smokers in intervention areas ( RR 1.30 , 95%CI
Output:
| The authors found that although the majority of adherence-enhancing interventions were cost-effective or cost-saving , variation exists within different intervention types . |
MS212942 | ***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: 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 Using an affective priming procedure ( S. T. Murphy & R. B. Zajonc , 1993 ) , 7 studies examined the effects of the context ual activation of representations of attachment security ( secure base schema ) on the evaluation of neutral stimuli under either neutral or stressful context s. In all the studies , participants also reported on their attachment style . Results indicated that the subliminal priming of secure base representations led to more positive affective reactions to neutral stimuli than did the subliminal priming of neutral or no pictures under both neutral and stressful context s. Although the subliminal priming of positively valued , attachment-unrelated representations heightened positive evaluations under neutral context s , it failed to elicit positive affect under stressful context s. The results also revealed interesting effects of attachment style . The discussion focuses on the affective component of the secure base schema Two studies investigated how context ually activating attachment relationships influences the working self-concept in terms of agency and communion . In Study 1 , 245 participants were primed with a secure , avoidant , or anxious-ambivalent relationship and the implicit accessibility of agency and communion was assessed using word fragments . Activating a secure relationship increased the accessibility of communion , whereas activating an anxious-ambivalent relationship increased the accessibility of agency . In Study 2 , 123 participants were primed with a secure , preoccupied , avoidant-dismissive , or avoidant-fearful relationship and explicit self-perceptions of agency and communion traits were assessed using the Extended Personality Attributes Question naire ( EPAQ ) . Gender interacted with the attachment prime , such that men primed with a secure relationship reported higher communion than did men primed with an avoidant ( dis-missive or fearful ) relationship , whereas women primed with an anxious ( preoccupied or fearful ) relationship reported higher agency than did women primed with a secure relationship Ninety 6- and 7-year-olds ( 49.3 % White , mostly middle class ) from greater Washington , DC were r and omly assigned to a subliminal priming condition ( secure , happy , or neutral ) to determine if attachment security priming decreases physiological , expressive , and self-reported fear reactions to threatening stimuli . Dispositional attachment security was also assessed . Secure priming and attachment security each decreased electrodermal reactivity , increased vagal augmentation , and decreased fearful facial expressions compared to control conditions . Examination of a statistical interaction between security priming and child attachment indicated that , although secure children had increased vagal augmentation and fewer fearful expressions than insecure children , the effects of priming were constant across secure and insecure children . There were no priming or attachment effects associated with children 's self-reported fear
Output:
| Thirty empirical studies met our inclusion criteria , including 28 adult and 2 child and adolescent sample s. The findings show that attachment security priming improved positive affect and reduced negative affect relative to control primes .
Importantly , repeated priming studies showed a cumulative positive effect of security priming over time .
We conclude that repeated priming study design s may be the most effective . |
MS212943 | ***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 evaluated the survival benefit , safety , feasibility , and tolerability of dose-dense ( DD ) adjuvant chemotherapy with epirubicin and paclitaxel for women with node-positive primary breast cancer . R and omised patients ( n=216 ) received DD or conventional-schedule ( CS ) chemotherapy . Dose-dense regimen patients ( n=108 ) received epirubicin 90 mg m−2 plus paclitaxel 175 mg m−2 in four 14-day cycles , then cyclophosphamide 600 mg m−2 , methotrexate 40 mg m−2 , and fluorouracil 600 mg m−2 ( CMF 600/40/600 ) in three 14-day cycles , plus filgrastim 5 μg kg day−1 as growth support in every cycle . Conventional-schedule regimen patients ( n=108 ) received epirubicin 90 mg m−2 plus cyclophosphamide 600 mg m−2 in four 21-day cycles , then CMF 600/40/600 in three 21-day cycles , plus filgrastim if required . After a median follow-up of 38.4 months , 71 patients ( 33 % ) relapsed or died : DD , 33 patients ( 15 deaths ) ; CS , 38 patients ( 22 deaths ) . Dose dense showed a trend for improved disease-free survival ( DFS ) and overall survival ( OS ) . Four-year rates of DFS and OS were 64 and 85 % for DD , and 58 and 75 % for CS . All seven cycles were administered to 208 patients ( 96 % ) . Rates of cycle delay , discontinuation , dose reduction , and adverse events were similar in both groups . Dose-dense sequential chemotherapy with epirubicin/paclitaxel then CMF , supported by filgrastim , is safe and improves survival for patients with node-positive breast cancer BACKGROUND Preoperative chemotherapy is a recommended treatment of both primary operable and locally advanced breast cancer . Strategies to improve efficacy include the use of anthracyclines , taxanes , and intensified dose with bone marrow support . PATIENTS AND METHODS Patients received neoadjuvant epirubicin 90 mg/m(2 ) plus cyclophosphamide 600 mg/m(2 ) followed by paclitaxel 175 mg/m(2 ) ( EC→T ) , each 3-weekly for four cycles ( n = 370 ) , or epirubicin 150 mg/m(2 ) followed by paclitaxel 225 mg/m(2 ) with pegfilgrastim followed by CMF ( cyclophosphamide 500 mg/m(2 ) , methotrexate 40 mg/m(2 ) , fluorouracil 600 mg/m(2 ) ) on days 1 and 8 ( E(dd)→T(dd)→CMF ) , each 2-weekly and for three cycles ( n = 363 ) . Patients were r and omly allocated to either simultaneous darbepoetin alfa ( DA ) ( n = 356 ) or none ( n = 377 ) . RESULTS Pathological complete response ( pCR ) rate ( breast ) was higher with E(dd)→T(dd)→CMF , 18.7 % versus 13.2 % with EC→T ; P = 0.043 , ypT0/Tis ; ypN0 was reported in 20.9 % versus 14.3 % respectively ; P = 0.019 . Patients with grade 3 tumors and negative hormone receptor status had a significantly higher pCR rate . Mean hemoglobin values maintained higher with DA ( 13.6 versus 12.6 g/dl ) . E(dd)→T(dd)→CMF regimen showed more grade 3 - 4 mucositis , sensory neuropathy , and neurological complaints . Thromboembolic events were more frequent on DA ( 3 % versus 6 % ; P = 0.055 ) . CONCLUSION Dose-dense and -intensified neoadjuvant chemotherapy with E(dd)→T(dd)→CMF was potentially superior to EC→T in terms of pCR . Primary use of DA did not affect pCR BACKGROUND To determine whether a dose-dense regimen improves outcome in early breast cancer patients , we compared outcomes with the same fluorouracil , epirubicin , and cyclophosphamide ( FEC ) chemotherapeutic regimen administered every 3 weeks ( FEC21 ) or administered every 2 weeks ( FEC14 including support with filgrastim , a granulocyte colony-stimulating factor ) in a multicenter phase III r and omized trial . METHODS A total of 1214 patients with early-stage breast cancer were r and omly assigned to receive six cycles of FEC14 ( 604 patients ) or of FEC21 ( 610 patients ) . Study endpoints were overall survival and event-free survival . Associations were assessed by multivariable analysis with adjustment for age ; tumor size ; grade ; proliferative rate ; and menopausal , lymph node , estrogen receptor , and progesterone receptor status . All statistical tests were two-sided . RESULTS Patients in the FEC14 arm had fewer dose reductions or treatment delays or discontinuation ( 26 % ) than those in the FEC21 arm ( 33 % ) ( difference = 7 % , 95 % confidence interval [ CI ] = 2 % to 12 % ; P = .008 ) . FEC14 therapy , compared with FEC21 therapy , was associated with more asthenia ( 36 % versus 29 % , difference = 7 % , 95 % CI = 2 % to 12 % ; P = .01 ) , bone pain ( 33 % versus 4 % , difference = 29 % , 95 % CI = 25 % to 33 % ; P < .001 ) , anemia ( 38 % versus 19 % , difference = 19 % , 95 % CI = 14 % to 24 % ; P < .001 ) , and thrombocytopenia ( 8 % versus 2 % , difference = 6 % , 95 % CI = 4 % to 9 % ; P < .001 ) , but with less leukopenia ( 12 % versus 45 % , difference = 33 % , 95 % CI = 28 % to 37 % ; P < .001 ) . No acute myelogenous leukemia or myelodysplastic syndrome was observed . At a median follow-up of 10.4 years , no statistically significant difference in the hazard of death ( hazard ratio [ HR ] = 0.87 , 95 % CI = 0.67 to 1.13 ) or recurrence ( HR = 0.88 , 95 % CI = 0.71 to 1.08 ) was found between FEC14 and FEC21 groups after adjustment by multivariable analysis . Although the study was underpowered for subset analysis , we found no evidence that the effect of the treatment type was associated with any of the potential prognostic factors . CONCLUSION Our results support the long-term safety of FEC14 chemotherapy as an adjuvant treatment of breast cancer . However , this therapy was not associated with improved outcome , but because of the limited statistical power of our study , we can not rule out a modest improvement in outcome associated with FEC14 therapy PURPOSE Using a 2 x 2 factorial design , we studied the adjuvant chemotherapy of women with axillary node-positive breast cancer to compare sequential doxorubicin ( A ) , paclitaxel ( T ) , and cyclophosphamide ( C ) with concurrent doxorubicin and cyclophosphamide ( AC ) followed by paclitaxel ( T ) for disease-free ( DFS ) and overall survival ( OS ) ; to determine whether the dose density of the agents improves DFS and OS ; and to compare toxicities . PATIENTS AND METHODS A total of 2,005 female patients were r and omly assigned to receive one of the following regimens : ( I ) sequential A x 4 ( doses ) -- > T x 4 -- > C x 4 with doses every 3 weeks , ( II ) sequential A x 4 -- > T x 4 -- > C x 4 every 2 weeks with filgrastim , ( III ) concurrent AC x 4 -- > T x 4 every 3 weeks , or ( IV ) concurrent AC x 4 -- > T x 4 every 2 weeks with filgrastim . RESULTS A protocol -specified analysis was performed at a median follow-up of 36 months : 315 patients had experienced relapse or died , compared with 515 expected treatment failures . Dose-dense treatment improved the primary end point , DFS ( risk ratio [ RR ] = 0.74 ; P = .010 ) , and OS ( RR = 0.69 ; P = .013 ) . Four-year DFS was 82 % for the dose-dense regimens and 75 % for the others . There was no difference in either DFS or OS between the concurrent and sequential schedules . There was no interaction between density and sequence . Severe neutropenia was less frequent in patients who received the dose-dense regimens . CONCLUSION Dose density improves clinical outcomes significantly , despite the lower than expected number of events at this time . Sequential chemotherapy is as effective as concurrent chemotherapy BACKGROUND The purpose of this study was to evaluate the impact of a dose-dense primary chemotherapy on pathological response rate ( pCR ) in patients with locally advanced breast cancer ( LABC ) treated with combined modality therapy . PATIENTS AND METHODS Stage IIIA/IIIB patients received three courses of induction chemotherapy ( ICT ) with cyclophosphamide , epirubicin and 5-fluorouracil ( CEF ) followed by local therapy ( total mastectomy or segmental mastectomy with axillary nodes dissection ) and adjuvant chemotherapy ( ACT ) with three courses of CEF alternated with three courses of cyclophosphamide , methotrexate , 5-fluorouracil ( CMF ) . Patients were r and omized to receive ICT and ACT every 3 weeks ( arm A , ' st and ard treatment ' ) or every 2 weeks with granulocyte-macrophage colony-stimulating factor ( GM-CSF ) support ( arm B , ' dose-dense treatment ' ) . In both arms radiotherapy was administered after the end of chemotherapy ( in selected cases ) and patients with hormonal receptor-positive tumors received tamoxifen for 5 years . RESULTS A total of 150 patients were r and omized ( 77 arm A and 73 arm B ) and demographics were well balanced between the two arms . Compliance to treatment was excellent : 95 % and 93 % of patients in arms A and B , respectively , completed the treatment program with no modification or delay . Median duration of treatment ( ICT+local+ACT ) was 183 days ( range 0 - 265 ) in arm A and 139 days ( 0 - 226 ) in arm B. The average relative dose intensity ( ARDI ) of chemotherapy was 1.3 with a 30 % increase in the dose intensity in arm B in comparison with arm A. No difference in clinical [ 62 % ; 95 % confidence interval ( CI ) 49 % to 73.2 % ] and pathological response rates to ICT was observed between the two arms . Median follow-up was 5 years ( range 1 - 96 months ) ; median disease-free survivals were 4.8 years in arm A and 4.5 years in arm B. Median overall survival was 7.8 years in st and ard therapy : this figure has not yet been reached in the dose-dense treatment . CONCLUSIONS In LABC a dose-dense regimen , while allowing a 30 % increase in the dose intensity of chemotherapy , did not provide significant improvement in pathological response rates . However , accelerated chemotherapy reduced the duration of the combined-modality program ( 6.1 versus 4.6 months ) with no additional toxicities The pattern of growth of human breast cancer is important theoretically and clinical ly . Speer et al. ( Cancer Res . , 44 : 4124 - 4130 , 1984 ) have recently proposed that all individual tumors initially grow with identical Gompertzian parameters , but subsequently develop kinetic heterogeneity by a r and om time-dependent process . This concept has elicited interest because it fits clinical data for the survival of untreated patients , for the progression of shadows on serial paired mammograms , and for time-to-relapse following mastectomy . The success of these curve-fits is compelling , and the model has been applied to clinical trials . However , the assumption of uniform nascent growth is not supported by theory or data , and individual cancers have not been shown to follow the complex growth curves predicted by the Speer model . As an alternative , if kinetic heterogeneity is understood to be an intrinsic property of neoplasia , the same three historical data sets are fit well by an unadorned Gompertzian model which is parsimonious and has many other intuitive and empirical advantages . The two models differ significantly in such clinical projections as the estimated duration of silent growth prior to diagnosis and the anticipated optimal chemotherapy schedule postsurgery BACKGROUND AND OBJECTIVES Treatment with CHOP chemotherapy in elderly patients with aggressive non-Hodgkin 's lymphoma ( NHL ) is less effective and accompanied by more adverse effects than in younger patients . The
Output:
| No benefit was observed in patients with hormone receptor-positive tumors .
Dose-dense chemotherapy results in better overall and disease-free survival , particularly in women with hormone receptor-negative breast cancer . |
MS212944 | ***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 Using longitudinal and prospect i ve measures of trauma during childhood , the authors assessed the risk of developing psychotic symptoms associated with maltreatment , bullying , and accidents in a nationally representative U.K. cohort of young twins . METHOD Data were from the Environmental Risk Longitudinal Twin Study , which follows 2,232 twin children and their families . Mothers were interviewed during home visits when children were ages 5 , 7 , 10 , and 12 on whether the children had experienced maltreatment by an adult , bullying by peers , or involvement in an accident . At age 12 , children were asked about bullying experiences and psychotic symptoms . Children 's reports of psychotic symptoms were verified by clinicians . RESULTS Children who experienced mal-treatment by an adult ( relative risk=3.16 , 95 % CI=1.92 - 5.19 ) or bullying by peers ( relative risk=2.47 , 95 % CI=1.74 - 3.52 ) were more likely to report psychotic symptoms at age 12 than were children who did not experience such traumatic events . The higher risk for psychotic symptoms was observed whether these events occurred early in life or later in childhood . The risk associated with childhood trauma remained significant in analyses controlling for children 's gender , socioeconomic deprivation , and IQ ; for children 's early symptoms of internalizing or externalizing problems ; and for children 's genetic liability to developing psychosis . In contrast , the risk associated with accidents was small ( relative risk=1.47 , 95 % CI=1.02 - 2.13 ) and inconsistent across ages . CONCLUSIONS Trauma characterized by intention to harm is associated with children 's reports of psychotic symptoms . Clinicians working with children who report early symptoms of psychosis should inquire about traumatic events such as maltreatment and bullying BACKGROUND Victims of bullying are at risk for psychotic experiences in early adolescence . It is unclear if this elevated risk extends into late adolescence . The aim of this study was to test whether bullying perpetration and victimization in elementary school predict psychotic experiences in late adolescence . METHOD The current study is based on the Avon Longitudinal Study of Parents and Children ( ALSPAC ) , a prospect i ve community-based study . A total of 4720 subjects with bullying perpetration and victimization were repeatedly assessed between the ages of 8 and 11 years by child and mother reports . Suspected or definite psychotic experiences were assessed with the Psychosis-Like Symptoms semi-structured interview at age 18 years . RESULTS Controlling for child 's gender , intelligence quotient at age 8 years , childhood behavioural and emotional problems , and also depression symptoms and psychotic experiences in early adolescence , victims [ child report at 10 years : odds ratio ( OR ) 2.4 , 95 % confidence interval ( CI ) 1.6 - 3.4 ; mother report : OR 1.6 , 95 % CI 1.1 - 2.3 ] , bully/victims ( child report at 10 years : OR 3.1 , 95 % CI 1.7 - 5.8 ; mother : OR 2.9 , 95 % CI 1.7 - 5.0 ) and bullies ( child report at 10 years : OR 4.9 , 95 % CI 1.3 - 17.7 ; mother : OR 1.2 , 95 % CI 0.46 - 3.1 , n.s . ) had a higher prevalence of psychotic experiences at age 18 years . Path analysis revealed that the association between peer victimization in childhood and psychotic experiences at age 18 years was only partially mediated by psychotic or depression symptoms in early adolescence . CONCLUSIONS Involvement in bullying , whether as victim , bully/victim or bully , may increase the risk of developing psychotic experiences in adolescence . Health professionals should ask routinely during consultations with children about their bullying of and by peers Observational studies have suggested that psychometric psychosis liability and a functional polymorphism in the catechol-O-methyltransferase ( COMT Val158Met ) gene moderate the psychosis-inducing effect of cannabis . To replicate and extend this finding , a double-blind , placebo-controlled cross-over design was used in which patients with a psychotic disorder ( n=30 ) , relatives of patients with a psychotic disorder ( n=12 ) , and healthy controls ( n=32 ) were exposed to Δ-9-tetrahydrocannabinol ( Δ-9-THC , the principal component of cannabis ) or placebo , followed by cognitive assessment and assessment of current psychotic experiences . Previous expression of psychometric psychosis liability was also assessed . Models of current psychotic experiences and cognition were examined with multilevel r and om regression analyses to assess ( i ) main effects of genotype and condition , ( ii ) interactions between condition and genotype , and ( iii ) three-way interactions between condition , genotype , and psychometric psychosis liability . Carriers of the Val allele were most sensitive to Δ-9-THC-induced psychotic experiences , but this was conditional on prior evidence of psychometric psychosis liability . Δ-9-THC impacted negatively on cognitive measures . Carriers of the Val allele were also more sensitive to Δ-9-THC-induced memory and attention impairments compared to carriers of the Met allele . Experimental effects of Δ-9-THC on cognition and psychosis are moderated by COMT Val158Met genotype , but the effects may in part be conditional on the additional presence of pre-existing psychosis liability . The association between cannabis and psychosis may represent higher order gene – environment and gene – gene interactions Positive and negative schizotypy exhibit differential patterns of impairment in social relations , affect , and functioning in daily life . However , studies have not examined the association of schizotypy with real-world expression of psychotic-like , paranoid , and negative symptoms . The present study employed experience-sampling methodology ( ESM ) to assess positive and negative schizotypy in daily life in a non clinical sample of 206 Spanish young adults . Participants were prompted r and omly 8 times daily for 1 week to complete assessment s of their current symptoms and experiences . Positive schizotypy was associated with psychotic-like and paranoid symptoms in daily life . Negative schizotypy was associated with a subset of these symptoms and with negative symptoms in daily life . Momentary stress was associated with psychotic-like and paranoid symptoms , but only for those high in positive schizotypy . Social stress predicted momentary psychotic-like symptoms in both positive and negative schizotypy . Time-lagged analyses indicated that stress at the preceding signal predicted psychotic-like symptoms at the current assessment , but only for individuals high in positive schizotypy . The results are consistent with models linking stress sensitivity with the experience of psychotic symptoms . The findings provide cross-cultural support for the multidimensional model of schizotypy and schizophrenia . Furthermore , the findings demonstrate that ESM is an effective method for predicting the experience of psychotic-like symptoms , as well as their precursors , in daily life OBJECTIVE Many studies have implicated prenatal infection in the etiology of schizophrenia . Cytokines , a family of soluble polypeptides , are critically important in the immune response to infection and in other inflammatory processes . The goal of this study was to determine whether second-trimester levels of four cytokines-interleukin-8 ( IL-8 ) , interleukin-1beta ( IL-1beta ) , interleukin-6 ( IL-6 ) , and tumor necrosis factor-alpha (TNF-alpha)-are higher in the mothers of offspring who later developed schizophrenia spectrum disorders than in matched comparison subjects . METHOD The authors conducted a nested case-control study of maternal serum cytokine levels in a large birth cohort , born 1959 - 1967 . Cases ( N=59 ) were subjects diagnosed with schizophrenia spectrum disorders ( mostly schizophrenia and schizoaffective disorder ) who had available second-trimester maternal serum sample s. Comparison subjects ( N=105 ) were members of the birth cohort , had not been diagnosed with a schizophrenia spectrum disorder or major affective disorder , and were matched to subjects with schizophrenia for date of birth , gender , length of time in the cohort , and availability of maternal sera . Maternal second-trimester serum levels of IL-8 , IL-1beta , IL-6 , and TNF-alpha were determined by s and wich enzyme-linked immunosorbent assay . RESULTS The second-trimester IL-8 levels in mothers of offspring with schizophrenia spectrum disorders were significantly higher than those of the mothers of comparison subjects . There were no differences between subjects with schizophrenia and comparison subjects with respect to maternal levels of IL-1beta , IL-6 , or TNF-alpha . CONCLUSIONS Using prospect ively collected prenatal sera in a large and well-characterized birth cohort , the authors have documented a significant association between maternal IL-8 level during the second trimester and risk of schizophrenia spectrum disorders in the offspring . These findings provide further support for a substantive role of in utero infection or inflammation in the etiology of schizophrenia . Moreover , these results may have important implication s for elucidating the mechanisms by which disrupted fetal development raises the risk of this disorder This article reports on the development and reliability of the Diagnostic Interview for Genetic Studies ( DIGS ) , a clinical interview especially constructed for the assessment of major mood and psychotic disorders and their spectrum conditions . The DIGS , which was developed and piloted as a collaborative effort of investigators from sites in the National Institute of Mental Health ( NIMH ) Genetics Initiative , has the following additional features : ( 1 ) polydiagnostic capacity ; ( 2 ) a detailed assessment of the course of the illness , chronology of psychotic and mood syndromes , and comorbidity ; ( 3 ) additional phenomenologic assessment s of symptoms ; and ( 4 ) algorithmic scoring capability . The DIGS is design ed to be employed by interviewers who exercise significant clinical judgment and who summarize information in narrative form as well as in ratings . A two-phase test-retest ( within-site , between-site ) reliability study was carried out for DSM-III-R criteria -based major depression , bipolar disorder , schizophrenia , and schizoaffective disorder . Reliabilities using algorithms were excellent ( 0.73 to 0.95 ) , except for schizoaffective disorder , for which disagreement on estimates of duration of mood syndromes relative to psychosis reduced reliability . A final best-estimate process using medical records and information from relatives as well as algorithmic diagnoses is expected to be more reliable in making these distinctions . The DIGS should be useful as part of archival data gathering for genetic studies of major affective disorders , schizophrenia , and related conditions Aim The present study employed Experience Sampling Methodology to examine whether the interaction between childhood bullying and FKBP5 variability ( i ) is associated with the expression of psychotic-like experiences , paranoia , and negative affect , and ( ii ) moderates psychotic-like , paranoid , and affective reactivity to different forms of momentary stress ( situational and social ) in daily life . Methods A total of 206 non clinical young adults were interviewed for bullying with the Childhood Experience of Care and Abuse and were prompted r and omly eight times daily for one week to complete assessment s of their current experiences , affect , and stress appraisal s. Participants were genotyped for three FKBP5 single nucleotide polymorphisms ( SNPs ) ( rs3800373 , rs9296158 , and rs1360780 ) that have been linked to hypothalamus-pituitary-adrenal axis reactivity . Multilevel analyses were conducted to examine the effect of the interaction between childhood bullying and the FKBP5 haplotype derived from these three SNPs . Results The interaction between bullying and the FKBP5 haplotype was associated with positive , but not negative , psychotic-like experiences , paranoia , and negative affect . The bullying x FKBP5 interaction also moderated the association of a social stress appraisal ( specifically , being alone because people do not want to be with you ) with psychotic-like experiences and negative affect in daily life . Simple slopes analyses indicated that , in all cases , the associations were significantly increased by exposure to bullying in participants with the risk haplotype , but not for those with the non-risk haplotype . Discussion The present study provides the first evidence of the interplay between childhood bullying and FKBP5 variability in the real-world expression of psychosis proneness and social stress reactivity . The findings underscore the importance of investigating how gene-environment interactions are involved in mechanistic pathways to the extended psychosis phenotype and lend further support to the increasing relevance given to socially defeating appraisal s in the experience of reality distortion The Clinical Global Impressions Scale ( CGI ) was modified specifically for use in assessing global illness severity and change in patients with bipolar disorder . Criticisms of the original CGI were addressed by correcting inconsistencies in scaling , identifying time frames for comparison , clarifying definitions of illness severity and change , and separating out assessment of treatment side effects from illness improvement during treatment . A Detailed User 's Guide was developed to train clinicians in the use of the new CGI-Bipolar Version ( CGI-BP ) for rating severity of manic and depressive episodes and the degree of change from the immediately preceding phase and from the worst phase of illness . The revised scale and manual provide a focused set of instructions to facilitate the reliability of these ratings of mania , depression , and overall bipolar illness during treatment of an acute episode or in longer-term illness prophylaxis . Interrater reliability of the scale was demonstrated
Output:
| Almost consistently , these studies revealed that polymorphisms in COMT , BDNF , and FKBP5 genes might interact with early life stress and cannabis abuse or dependence , influencing various outcomes of schizophrenia spectrum disorders and BD . |
MS212945 | ***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: Flutrimazole is an imidazole derivative that has been proven to be efficient in superficial skin fungal infections . The aim of this r and omised double-blind study was to compare for the first time , the efficiency and safety of flutrimazole 1 % shampoo versus ketoconazole 2 % shampoo in the treatment of tinea versicolor . Study population consisted of 60 patients with pityriasis versicolor diagnosed clinical ly and through direct microscopy and culture . Patients were r and omly assigned to two groups : one instructed to apply flutrimazole shampoo 1 % and one instructed to apply ketoconazole shampoo 2 % both on head and body for 14 days . Patients were re-evaluated 14 days after the end of treatment clinical ly and through direct microscopy and culture . Twenty-one of 26 patients ( 80.8 % ) in the ketoconazole and 22 of 29 patients ( 75.9 % ) in the flutrimazole group had both visual healing and negative mycological evaluation . Comparison of the response between the two groups with the Yates ' corrected chi-square was found statistically not significant ( chi(2 ) = 0.19 , d.f . = 1 , P = 0.91 ) . None of the patients in the two groups reported any adverse effects . Fourteen ( 53 % ) patients in the ketoconazole group and 23 ( 79 % ) in the flutrimazole group assessed the shampoos as cosmetically acceptable regarding texture , smell and foam properties . Flutrimazole shampoo 1 % appears to present efficacy comparable with ketoconazole 2 % in the treatment of tinea versicolor Malassezia furfur ( Pityrosporum orbiculare ) was confirmed by microscopic potassium hydroxide ( KOH ) examination in 101 patients with recurring lesions of tinea versicolor . In a double-blind comparative study , patients were r and omly assigned to once-daily ketoconazole 2 % or placebo cream . At the end of treatment , 98 % ( p less than 0.0001 ) of the patients using ketoconazole and 28 % of those using placebo responded clinical ly ( healed or had mild residual disease ) . There was an overall 84 % mycologic cure rate ( negative KOH at treatment end ) for patients using ketoconazole 2 % cream and 10 % for those using placebo cream ( p less than 0.0001 ) . Ketoconazole-treated patients who were cured at the end of treatment remained cured 8 weeks later . By contrast 75 % of those responding to placebo had relapsed by the 8-week follow-up visit . Follow-up after 2 years revealed that 79 % ( 38/48 ) of the patients treated with ketoconazole remained clear 12 or more months Abstract Background : Ketoconazole cream and adapalene gel are effective drugs against pityriasis versicolor . However , there are no reports on combination treatment with both compounds in pityriasis versicolor . Objective : To evaluate the efficacy and safety of combination therapy with adapalene 0.1 % gel and ketoconazole 2 % cream against pityriasis versicolor . Methods : Participants with pityriasis versicolor were r and omly assigned to two groups : the combination group was treated with adapalene 0.1 % gel and ketoconazole 2 % cream once daily , and the monotherapy group received ketoconazole 2 % cream twice daily . The treatment lasted 2 weeks in both groups . Outcomes were assessed at baseline and 1 , 2 and 4 weeks after the initiation of treatment . Results : We noted clinical ly significant differences in total improvement rates between groups Weeks 1 and 2 . A statistically significant difference was obtained Week 4 . The treatment was well tolerated by all participants . Conclusions : The combination of adapalene 0.1 % gel and ketoconazole 2 % cream is effective and safe in the treatment of pityriasis versicolor . This therapeutic regimen was rapid , providing a valuable option for patients with pityriasis versicolor BACKGROUND Tinea versicolor is a common superficial fungal infection caused by a lipophilic yeast . This chronically recurring opportunistic infection is especially prevalent in tropical and semitropical regions . The topical short-term application of ketoconazole 2 % shampoo may provide effective and safe therapy for tinea versicolor . OBJECTIVE The purpose of this study was to evaluate the efficacy and safety of a single application ( 1 day ) versus three daily applications ( 3 days ) of ketoconazole 2 % shampoo versus placebo shampoo in the treatment of mycologically confirmed tinea versicolor . METHODS Three hundred twelve patients were included in the primary analyses for this 31-day study . Global evaluation scores were measured on days 10 and 31 with a 5-point scale ( 1 = healed to 5 = worsening ) , and a cellophane tape test was done at baseline and days 3 , 10 , and 31 . Efficacy was assessed by clinical response , defined as both a global evaluation score of 1 ( healed ) and a negative cellophane tape test on day 31 . Signs and symptoms of tinea versicolor ( scaling , itching , erythema , hypopigmentation , hyperpigmentation ) also were evaluated at baseline , day 10 , and day 31 with a 4-point scale ( 0 = absent to 3 = severe ) . RESULTS Both regimens of ketoconazole shampoo were significantly ( P < .001 ) more effective than placebo for rate of clinical response , global evaluation scores , and mycologic outcomes ( cellophane tape test ) . The clinical response rates at day 31 were 73 % , 69 % , and 5 % for the 3-day ketoconazole , 1-day ketoconazole , and placebo groups , respectively . The difference in the efficacy of the two ketoconazole treatment regimens was not statistically significant . There were no significant differences between any of the treatment groups in the number of patients who experienced adverse events . No serious adverse events occurred and no patient withdrew from the trial prematurely because of an adverse event . CONCLUSION Ketoconazole 2 % shampoo , used as a single application or daily for 3 days , is safe and highly effective in the treatment of tinea versicolor The antifungal efficacy and tolerability of 1 % terbinafine cream vs. 1 % bifonazole cream were assessed in a single blind r and omized trial in patients with pityriasis versicolor . Terbinafine , a drug of the allylamines group , a new class of anti-mycotic agents , blocks sterol bio synthesis in the pathogen through inhibition of squalene epoxidase and consequent squalene accumulation , a primarily fungicidal process . Forty pityriasis versicolor patients , ( 18 M , 22 F ; mean age 32.4 years ; min . 16 , max . 65 ) , used 1 % terbinafine cream or 1 % bifonazole cream for a maximum of 4 weeks . All patients were followed-up weekly both clinical ly and mycologically . Clinical cures , defined as negativization of each clinical parameter , were recorded for 20 terbinafine patients ( 100 % ) and 19 bifonazole patients ( 95 % ) , with routine microscopy and Wood 's light tests both negative . By the 2nd week of treatment , 2 terbinafine patients were mycologically cured ( 10 % ) . By the 3rd week , 14 terbinafine patients ( 70 % ) and 5 bifonazole patients ( 25 % ) were mycologically cured . The present controlled clinical trial consequently demonstrates that terbinafine is rapidly effective and well tolerated for treatment of pityriasis versicolor An open , comparative trial of two brief regimens of itraconazole for pityriasis versicolor was carried out . Twenty-four patients received 100 mg twice a day for five days , and 23 received 100 mg once a day for five days . Patients were enrolled in the study on the basis of the presence of clinical symptoms and positive findings on direct microscopic examination . Tolerance to the drug and mycologic and clinical outcome were assessed on days 6 , 14 , and 28 after the initiation of treatment . For 23 patients in each group , skin sample s were negative for fungi by day 18 . Clinical improvement was slow ; first scaling disappeared and then erythema and inflammation . Dyschromia persisted during the observation period . Six patients had adverse reactions to treatment ; none discontinued treatment BACKGROUND The use of short-term oral azoles is an alternative to topical therapy in patients with tinea versicolor . OBJECTIVE We compared the efficacy and safety of oral itraconazole with that of placebo in 36 patients with mycologically proven tinea versicolor . METHODS Patients were r and omly assigned to 7 days of treatment with either itraconazole , 200 mg once daily , or placebo . A potassium hydroxide examination and assessment of scaling , erythema , pruritus , and global condition were performed at baseline and at 4 weeks after treatment . RESULTS The itraconazole-treated group demonstrated significant improvement over both baseline ( p < 0.01 ) and placebo ( p < 0.02 ) in scaling , erythema , and pruritus . Sixty-seven percent of itraconazole-treated patients were free of symptoms at week 5 , as compared with 12 % of placebo-treated patients . Ninety-four percent of itraconazole-treated patients were considered to be healed or markedly improved at the study 's end point compared with 6 % of placebo-treated patients ( p < 0.01 ) . A total of 89 % in the itraconazole-treated group had a negative potassium hydroxide examination at the follow-up visit compared with 6 % in the placebo-treated group ( p < 0.01 ) . There was a single report of a possibly treatment-related adverse event in each treatment group . CONCLUSION Short-term treatment with itraconazole is effective and well tolerated in the management of tinea versicolor Two r and omized , double-blind , parallel-group studies , each conducted at five medical centers , assessed the efficacy and safety of a new antifungal agent , ciclopirox olamine cream 1 % , in patients with tinea versicolor . In one study , the antifungal agent was compared with its cream vehicle ; in the other , it was compared with another antifungal compound , 1 % clotrimazole cream . In both studies , treatments were applied twice daily for 14 days . Results with ciclopirox olamine cream were significantly better ( P less than 0.05 ) than those with the vehicle alone after one and two weeks of therapy and at one and two weeks posttherapy . After two weeks of treatment , 49 % of the 73 patients treated with the antifungal cream were clinical ly and mycologically cured , whereas only 24 % of the 72 patients using the vehicle were similarly cured ( P less than 0.001 ) . The clinical cure rate with ciclopirox olamine cream also was significantly better ( P less than 0.05 ) than that with clotrimazole cream . After two weeks of treatment , 77 % of the patients treated with ciclopirox olamine , compared with 45 % of those treated with clotrimazole , had both clinical and mycological cures ( P less than or equal to 0.001 ) . Fourteen days posttreatment , the proportion of patients with a combined response was still greater in the ciclopirox olamine group ( 86 % ) than in the clotrimazole group ( 73 % ) . No side effects were observed in any treatment group Ketomousse ( K ) , a new thermophobic formulation ( ketoconazole 1 % ) , has proven its efficacy in the treatment of d and ruff , caused by the same agent as pityriasis versicolor ( PV ) . The objective of this study was to compare the efficacy and tolerability of K thermophobic foam vs. ketoconazole cream 2 % ( N ) in the treatment of PV . Forty-six patients ( 22 in K and 24 in N group ) with PV involving no more than 15 % of the total trunk surface were r and omly assigned for treatment either with K or N once daily for 14 days . Three weeks after the completion of treatment , improvement rate and side-effects were evaluated by clinical and mycological examination ( Wood 's light ) . Follow-up was available for 81 % of subjects . Complete resolution was observed in five patients ( 29 % ) in K group and in nine ( 47 % ) in N group ( P = 0.291 ) . One patient in the N group reported urticaria while no adverse events were reported for K. Both products were cosmetically acceptable with respect to feasibility of application and formulation with a preference for K. Ketomousse ( 1 % ketoconazole ) provides an equal efficacy and tolerability compared to ketoconazole cream 2 % . Therefore , Ketomousse could be considered an excellent therapeutic option in the treatment of PV BACKGROUND : Tinea ( pityriasis ) versicolor is a superficial infection of the stratum corneum by the lipophilic fungus known as Malassezia furfur . OBJECTIVE : To evaluate the efficacy and safety of a 400 mg single dose or 7-day 200 mg daily dose of itraconazole capsules in the treatment of mycologically confirmed pityriasis versicolor . METHODS : A total of 50 patients were entered
Output:
| Conclusions : Topical antifungal medications are the first-line treatment for PV , including zinc pyrithione , ketoconazole , and terbinafine .
In cases of severe or recalcitrant PV , the oral antifungal medications itraconazole and fluconazole may be more appropriate , with pramiconazole a possible future option .
Maintenance , or prophylactic , therapy may be useful in preventing recurrent infection ; however , at this time , there is limited research evaluating the efficacy of prophylactic antifungal treatment |
MS212946 | ***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: 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 To determine the prevalence and characteristics of fibromyalgia in the general population . METHODS A r and om sample of 3,006 persons in Wichita , KS , were characterized according to the presence of no pain , non-widespread pain , and widespread pain . A sub sample of 391 persons , including 193 with widespread pain , were examined and interviewed in detail . RESULTS The prevalence of fibromyalgia was 2.0 % ( 95 % confidence interval [ 95 % CI ] 1.4 , 2.7 ) for both sexes , 3.4 % ( 95 % CI 2.3 , 4.6 ) for women , and 0.5 % ( 95 % CI 0.0 , 1.0 ) for men . The prevalence of the syndrome increased with age , with highest values attained between 60 and 79 years ( > 7.0 % in women ) . Demographic , psychological , dolorimetry , and symptom factors were associated with fibromyalgia . CONCLUSION Fibromyalgia is common in the population , and occurs often in older persons . Characteristic features of fibromyalgia -- pain threshold and symptoms -- are similar in community and clinic population s , but overall severity , pain , and functional disability are more severe in the clinic population Pain is a syndrome characterized by several neurophysiological changes including that of the autonomic nervous system . Chronic low back pain ( LBP ) is a major health problem and is a frequent reason for using unconventional therapies especially acupuncture . This study was conducted to evaluate the autonomic status and pain profile in chronic LBP patients and to observe the effect of electro acupuncture therapy . Chronic LBP patients ( n=60 ) were recruited from the Department of Orthopaedics , GTB Hospital , Delhi . Age and sex matched healthy volunteers were selected as controls ( n=30 ) . Following a written consent , LBP patients were r and omly allocated into two study groups - Group A received 10 sittings of electro acupuncture , on alternate days , at GB and UB points selected for back pain , while the Group B received a conventional drug therapy in the form of oral Valdecoxib together with supervised physiotherapy . Controls were assessed once while the patients were assessed twice , before and after completion of the treatment program ( 3 weeks ) . The autonomic status was studied with non-invasive cardiovascular autonomic function tests which included E : I ratio , 30:15 ratio , postural challenge test and sustained h and grip test . Pain intensity was measured with the visual analogue scale ( VAS ) and the global perceived effect ( GPE ) . Statistical analysis was performed using repeated measure 's ANOVA with Tukey 's test . Pain patients showed a significantly reduced vagal tone and increased sympathetic activity as compared to the controls ( P<0.05 to P<0.001 in different variables ) . Following treatment , both the study groups showed a reduction in vagal tone together with a decrease in the sympathetic activity . There was also a considerable relief of pain in both groups , however , the acupuncture group showed a better response ( P<0.01 ) . We conclude that there is autonomic dysfunction in chronic LBP patients . Acupuncture effectively relieves the pain and improves the autonomic status and hence can be used as an alternative/additive treatment modality in these cases The aim of the present study was to investigate reactions in trapezius muscle blood flow ( MBF ) , muscle activity , heart rate variability ( HRV ) and systemic blood pressure ( BP ) to autonomic tests in subjects with chronic neck – shoulder pain and healthy controls . Changes in muscle activity and blood flow due to stress and unfavourable muscle loads are known underlying factors of work-related muscle pain . Aberration of the autonomic nervous system ( ANS ) is considered a possible mechanism . In the present study , participants ( n = 23 Pain , n = 22 Control ) performed autonomic tests which included a resting condition , static h and grip test ( HGT ) at 30 % of maximal voluntary contraction , a cold pressor test ( CPT ) and a deep breathing test ( DBT ) . HRV was analysed in time and frequency domains . MBF and muscle activity were recorded from the upper trapezius muscles using photoplethysmography and electromyography ( EMG ) . The pain group showed reduced low frequency-HRV ( LF ) and SDNN during rest , as well as a blunted BP response and increased LF-HRV during HGT ( ∆systolic 22 mm Hg ; ∆LF(nu ) 27 % ) compared with controls ( ∆systolic 27 ; ∆LF(nu ) 6 % ) . Locally , the pain group had attenuated trapezius MBF in response to HGT ( Pain 122 % Control 140 % ) with elevated trapezius EMG following HGT and during CPT . In conclusion , only HGT showed differences between groups in systemic BP and HRV and alterations in local trapezius MBF and EMG in the pain group . Findings support the hypothesis of ANS involvement at systemic and local levels in chronic neck – shoulder pain UNLABELLED Several case-control studies have been conducted that examine the association between autonomic variables and persistent pain conditions ; however , there is a surprising dearth of published studies in this area that have focused on temporom and ibular disorders ( TMD ) . The current study presents autonomic findings from the baseline case-control study of the OPPERA ( Orofacial P
Output:
| High heterogeneity aside , pooled results from the meta-analyses reflected a consistent , moderate-to-large effect of decreased high-frequency HRV in chronic pain , implicating a decrease in parasympathetic activation .
These effects were heavily influenced by fibromyalgia studies . |
MS212947 | ***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 Freeze-dried acellular dermal matrix ( ADM ) allograft , originally used for full-thickness burn wounds , was recently introduced as an alternative to the autogenous free gingival graft ( FGG ) in achieving increased attached keratinized tissue . The aim of part 1 of this study was to investigate the clinical efficacy of the ADM allograft for this particular purpose . METHODS Twelve patients , 7 males and 5 females , with attached gingiva < or = 1 mm on the facial aspect of m and ibular anterior teeth demonstrating a tendency of progressive marginal tissue recession , were r and omly assigned to either test or control treatment . Six patients received ADM graft ( test ) and 6 patients received an autogenous FGG harvested from the hard palate ( control ) . Clinical variables including plaque index ( PI ) , gingival index ( GI ) , probing depth ( PD ) , attached tissue width ( AT ) , and gingival recession ( GR ) were recorded immediately before surgery and at the 6-month postoperative visit . Patients were seen at 2 , 4 , 6 , 8 , and 12 weeks to monitor wound healing and oral hygiene performance ( PI and GI ) . Graft width was also measured , in corono-apical direction , on individually involved teeth during the surgery . RESULTS When values between baseline and 6 months were compared in both groups , there was no statistically significant difference in changes of PI , GI , PD , and GR ( P>0.05 ) with the exception of PD in the FGG group ( 1.01 + /- 0.03 versus 1.27 + /- 0.20 mm , P= 0.042 ) . There was a statistically significant ( P < 0.05 ) increase in AT in both groups . Although the ADM group received wider grafts than the FGG group ( 8.81 + /- 0.46 versus 6.70 + /- 0.89 mm ) , the AT gain was significantly smaller ( 2.59 + /- 0.92 versus 5.57 + /- 0.44 mm ) and the graft shrinkage significantly greater ( 71 + /- 10 % versus 16 + /- 12 % ) in the ADM group than in the FGG group ( P<0.01 ) . CONCLUSIONS The results of this study suggest that in procedures aim ing at increasing the width of attached gingiva : 1 ) the ADM allograft was less effective and less predictable than the autogenous FGG in terms of increasing attached keratinized tissue due to considerable shrinkage and inconsistent quality of the attached tissue gained and 2 ) the esthetic results using the ADM allograft might be better than those using the autogenous FGG BACKGROUND Periodontists have found the gingival autograft to be an effective and predictable technique to increase the amount of attached gingiva around teeth , but this technique requires the surgeon to harvest donor tissue from a remote surgical site . The present study seeks to evaluate the safety and effectiveness of a tissue-engineered skin equivalent , a living human fibroblast-derived dermal substitute ( HF-DDS ) , compared to a gingival autograft ( GA ) consisting of donor tissue harvested from the patient 's palate in a procedure design ed to increase the amount of keratinized tissue around teeth that do not require root coverage . METHODS Twenty-five patients with insufficient attached gingiva associated with at least two teeth in contralateral quadrants of the same jaw were treated . One tooth in each patient was r and omized to receive either a GA ( control ) or a HF-DDS graft ( test ) . Clinical parameters measured at baseline and 3 , 5 , 7 , 9 , and 12 months included recession , clinical attachment level , keratinized tissue height , and plaque index . Probing depth was measured at 7 , 9 , and 12 months . Inflammation of each site was scored and texture and color of the grafted tissue were compared to the surrounding tissue . Resistance to muscle pull was evaluated and a question naire was used to determine patient preference . Surgical position of the graft and alveolar bone level were recorded at the surgical visit and patients were evaluated weekly for the first 4 weeks at which time recession and level of oral hygiene were measured . Biopsies and persistence studies were performed on a subset of the patients . RESULTS Results for both test and control groups were similar for all measured clinical parameters with the exception of amount of keratinized tissue and percent shrinkage of keratinized tissue . The control group exhibited an average of 1.0 to 1.2 mm more keratinized tissue over time than the test group ( P < 0.001 ) and the control group had about half as much shrinkage as the test group over time ( P < 0.001 ) . Test sites demonstrated significantly better color match over time compared to control sites . Similarly , tissue texture for test sites was significantly better than control sites over time . CONCLUSIONS Based on the results of this investigation , the tissue engineered HF-DDS graft was safe and capable of generating keratinized tissue without the morbidity and potential clinical difficulties associated with donor site surgery . The GA generated more keratinized tissue and shrank less than the HF-DDS graft , but the test graft generated tissue that appeared more natural BACKGROUND This study evaluated the safety and effectiveness of a tissue-engineered skin product composed of viable neonatal keratinocytes and fibroblasts and compared it to a free gingival graft ( FGG ) in a procedure to enhance keratinized tissue ( KT ) and wound healing around teeth that do not require root coverage . METHODS Twenty-five subjects were enrolled who had at least two non-adjacent teeth in contralateral quadrants exhibiting an insufficient zone of attached gingiva requiring soft tissue grafting where root coverage was not desired . One tooth was r and omized to receive an FGG , and the other was r and omized to receive bilayered cell therapy ( BCT ) . The amount of KT was measured at baseline and 3 and 6 months , and the texture and color of the grafted tissue were compared to the surrounding tissue at months 1 , 3 , and 6 . A question naire was used to determine subject preference at 6 months . Biopsies and persistence studies were performed on a subset of the subjects . RESULTS The FGG generated statistically significantly ( P < 0.001 ) more KT than the test device ( BCT ) ( 4.5 + /- 0.80 mm versus 2.4 + /- 1.02 mm ) ; no significant difference in recession or clinical attachment level was detected between treatment groups ( P = 0.212 and P = 0.448 , respectively ) ; and no significant differences were detected at any time point for bleeding on probing ( BOP ) , resistance to muscle pull , or inflammation . The BCT group had significantly better color and texture match with surrounding tissue ( P < 0.001 ) , and subject preference was significantly greater for the BCT group ( P = 0.041 ) . No device-related adverse events or safety issues occurred during the course of the study . CONCLUSIONS The tissue-engineered graft BCT was safe and capable of generating de novo KT without the morbidity and potential clinical difficulties associated with donor-site surgery . The amount of KT generated with FGG was greater than generated with BCT ; however , 24 of 25 test sites demonstrated an increase in KT at 6 months , with more than three-quarters of the sites yielding > or = 2 mm b and s of KT 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 This study was conducted to compare the efficacy and feasibility of an extracellular matrix membrane ( DynaMatrix ) with that of an autogenous gingival graft in increasing the width of attached keratinized tissue . Six patients with an inadequate amount of attached keratinized gingiva on the bilateral facial aspect of the m and ibular posterior teeth were recruited for this study . The defect sites were r and omly subjected to receive either test ( DynaMatrix membrane ) or control ( autogenous gingival graft ) treatment . Both test and control sites achieved a clinical ly significant increase in the amount of keratinized gingiva , and the DynaMatrix membrane-treated sites blended well with the surrounding tissue , with a better appearance when compared to the autogenous gingival grafted sites . The biopsy specimens of both test and control sites appeared to be similar histologically , with mature connective tissue covered by keratinized epithelium . The results of both clinical and histologic evaluations have suggested a potential application of an extracellular matrix membrane in achieving gingival augmentation BACKGROUND The aim of this study was to evaluate clinical ly , histologically , and ultrastructurally the integration process of the acellular dermal matrix used to increase the b and of keratinized tissue while achieving gingival inflammation control . METHODS Ten patients exhibiting a mucogingival problem with b and s of keratinized tissue < or=1 mm and gingival inflammation of the related teeth were included in the study . The surgical procedures were performed to augment the gingival tissue using acellular dermal matrix . Clinical measurements were assessed at baseline and after 3 months . A specimen of the allograft and surrounding tissues was obtained immediately before the surgery and 4 minutes and 1 , 2 , 3 , 4 , 6 , and 10 weeks after grafting . RESULTS Clinical ly , a gain of keratinized tissue of 2.92 + /- 0.65 mm was observed after 3 months . Histologically and ultrastructurally , many macrophages were observed phagocytosing preexisting collagen fibers in the first weeks . From week 2 on , fibroblasts synthesizing new collagen , epithelial cells colonizing the graft surface , and revascularization were noticed . After 6 weeks it was difficult to find the acellular dermal matrix preexisting collagen fibers . This process of substitution was completed after 10 weeks , when the reepithelialization of the entire graft throughout a well-structured basement membrane was achieved . CONCLUSION The acellular dermal matrix graft seemed to be an easily h and led material for use in keratinized tissue augmentation that , in humans , was substituted and completely reepithelialized in 10 weeks according to histologic and ultrastructural results This prospect i ve split-mouth pilot case series compared the use of a bilayer collagen matrix ( CM ) to an autogenous gingival graft ( AGG ) in the ability to increase the zone of keratinized attached gingiva . Five patients with inadequate amounts of keratinized attached gingiva bilaterally in the posterior m and ible were enrolled using a split-mouth design . There were statistically significant increases in attached gingiva at all test ( CM ) and control ( AGG ) sites . The CM sites at 12 months blended well with surrounding tissues , while the AGG sites were morphologically dissimilar to the adjacent areas . Biopsy results showed intrapatient histologic similarity between CM and AGG treatments , with all sites exhibiting mature connective tissue covered by keratinized epithelium . Thus , the obtained data support further investigations in evaluating the role of CM as a viable alternative to AGG in augmenting areas deficient in keratinized gingiva BACKGROUND The importance of keratinized tissue is a controversial subject . However , in some situations most clinicians would agree that surgical procedures to increase the amount of keratinized tissue without root coverage are indicated . In this study , 3 surgical procedures were compared in their ability to increase the width of keratinized tissue . They are : the epithelized autogenous masticatory mucosa graft ( free gingival graft ) , autogenous predominately connective tissue graft ( connective tissue graft ) , and acellular dermal matrix . METHODS Forty-five patients referred for treatment of areas with inadequate keratinized tissue were r and omly assigned into 1 of 3 groups of 15 each . Each group was treated with 1 of the 3 surgical procedures to increase the width of keratinized tissue . The width of keratinized tissue pre- and postsurgery was evaluated . RESULTS All 3 groups started with a similar width of keratinized tissue . All of the surgical procedures result ed in a statistically significant increase in the width of keratinized tissue : free gingival graft , 4.1 mm ; connective tissue graft , 3.6 mm ; and acellular dermal matrix , 4.1 mm . CONCLUSION A statistically significant increase in the amount of keratinized tissue was obtained with all 3 surgical procedures evaluated AIM The aim of this study was to test a new collagen matrix ( CM ) aim ed to increase keratinized gingiva/mucosa when compared with the free connective tissue graft ( CTG ) . MATERIAL AND METHODS This r and omized longitudinal parallel controlled clinical trial studied 20 patients with at least one location with minimal keratinized tissue ( < or=1 mm ) . MAIN OUTCOME MEASURE The 6-month width of keratinized tissue . As secondary outcomes , the aesthetic outlook , the maintenance of periodontal health and the patient morbidity were assessed pre-operatively at 1 , 3 and 6 months . RESULTS At 6 months , the CTG attained a mean width of keratinized tissue of 2.6 ( 0.9 ) mm , while the CM was 2.5 ( 0.9 ) mm , these differences being insignificant . In both groups , there was a marked contraction ( 60 % and 67 % , respectively ) although the periodontal parameters were not affected . The CM group had a significantly lower patient morbidity ( pain and medication intake ) as well as reduced surgery time . CONCLUSIONS These results prove that this new CM was as effective and predictable as the CTG for attaining a b and of keratinized tissue , but its use was associated with a significantly
Output:
| Conclusions Based on the clinical outcomes , the results of this systematic review and meta‐ analysis showed that soft tissue alternatives result in an increased width of KT . |
MS212948 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE Little progress has been made in the treatment of adult high- grade gliomas over the last two decades , thus necessitating a search for novel therapeutic strategies . Malignant gliomas are vascular or angiogenic tumors , which leads to the supposition that angiogenesis inhibition may represent a potentially promising strategy in the treatment of these tumors . We present the results of a phase II trial of thalidomide , a putative inhibitor of angiogenesis , in the treatment of adults with previously irradiated , recurrent high- grade gliomas . PATIENTS AND METHODS Patients with a histologic diagnosis of anaplastic mixed glioma , anaplastic astrocytoma , or glioblastoma multiforme who had radiographic demonstration of tumor progression after st and ard external-beam radiotherapy with or without chemotherapy were eligible . Patients were initially treated with thalidomide 800 mg/d with increases in dose by 200 mg/d every 2 weeks until a final daily dose of 1,200 mg was achieved . Patients were evaluated every 8 weeks for response by both clinical and radiographic criteria . RESULTS A total of 39 patients were accrued , with 36 patients being assessable for both toxicity and response . Thalidomide was well tolerated , with constipation and sedation being the major toxicities . One patient developed a grade 2 peripheral neuropathy after treatment with thalidomide for nearly a year . There were two objective radiographic partial responses ( 6 % ) , two minor responses ( 6 % ) , and 12 patients with stable disease ( 33 % ) . Eight patients were alive more than 1 year after starting thalidomide , although almost all with tumor progression . Changes in serum levels of basic fibroblastic growth factor ( bFGF ) were correlated with time to tumor progression and overall survival . CONCLUSION Thalidomide is a generally well-tolerated drug that may have antitumor activity in a minority of patients with recurrent high- grade gliomas . Future studies will better define the usefulness of thalidomide in newly diagnosed patients with malignant gliomas and in combination with radiotherapy and chemotherapy . Additionally , studies will be needed to confirm the potential utility of changes in serum bFGF as a marker of antiangiogenic activity and /or glioma growth
Output:
| The benefit of antineoplastic combined with whole brain radiation for brain metastases was not concerned , either in the brain metastases from unselected primary tumors or lung cancer |
MS212949 | ***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 Combination chemotherapy has shown benefit in the treatment of biliary cancer and further improvements might be achieved by the addition of a biological agent . We report here the effect of chemotherapy with the monoclonal EGFR antibody panitumumab as therapy for KRAS wild-type biliary cancer . PATIENTS AND METHODS Patients with advanced biliary tract cancer were r and omised ( 2:1 ) to receive cisplatin 25 mg/m2 and gemcitabine 1000 mg/m2 on day 1 and day 8/q3w with ( arm A ) or without panitumumab ( arm B ; 9 mg/kg BW , i.v q3w ) . The primary end-point was the evaluation of progression-free survival ( PFS ) at 6 months . Secondary end-points included objective response rate ( ORR ) , overall survival ( OS ) , and toxicity . In addition , a post hoc assessment of genetic alterations was performed . Finally , we performed a meta- analysis of trials with chemotherapy with and without EGFR antibodies . RESULTS Sixty-two patients were r and omised in arm A and 28 patients in arm B. Patients received 7 treatment cycles in median ( 1 - 35 ) with a median treatment duration of 4.7 months ( 141 days , 8 - 765 ) . PFS rate at 6 months was 54 % in patients treated with cisplatin/gemcitabine and panitumumab but was 73 % in patients treated with cisplatin/gemcitabine without antibody , respectively . Secondary end-points were an ORR of 45 % in treatment arm A compared with 39 % receiving treatment B and a median OS of 12.8 months ( arm A ) and of 20.1 months ( arm B ) , respectively . In contrast to the p53-status , genetic alterations in IDH1/2 were linked to a high response after chemotherapy and prolonged survival . In accordance with our results , the meta- analysis of 12 trials did not reveal a survival advantage for patients treated with EGFR antibodies compared with chemotherapy alone . CONCLUSIONS Panitumumab in combination with chemotherapy does not improve ORR , PFS and OS in patients with KRAS wild-type , advanced biliary cancer . Genetic profiling should be included in CCA trials to identify and vali date predictive and prognostic biomarkers . CLINICAL TRIALS NUMBER The trial was registered with NCT01320254 BACKGROUND Combination chemotherapy with gemcitabine and a platinum-based agent is regarded as a st and ard treatment for patients with advanced biliary-tract cancer . Results of phase 2 trials of single-agent erlotinib in biliary-tract cancer and of gemcitabine plus erlotinib in pancreatic cancer have shown modest benefits . Therefore , we aim ed to investigate the efficacy of gemcitabine and oxaliplatin plus erlotinib versus chemotherapy alone for advanced biliary-tract cancer . METHODS In this open label , r and omised , phase 3 trial , we r and omly assigned patients ( in a 1:1 ratio ) with metastatic biliary-tract cancer ( cholangiocarcinoma , gallbladder cancer , or ampulla of Vater cancer ) to receive either first-line treatment with chemotherapy alone ( gemcitabine 1000 mg/m(2 ) on day 1 and oxaliplatin 100 mg/m(2 ) on day 2 ) or chemotherapy plus erlotinib ( 100 mg daily ) . Treatment was repeated every 2 weeks until disease progression or unacceptable toxic effects . R and omisation was done central ly ( stratified by participating centre and presence of measurable lesion ) . The primary endpoint was progression-free survival . Analyses were by intention-to-treat . This study is registered with Clinical Trials.gov , number NCT01149122 . FINDINGS 133 patients were r and omly assigned to the chemotherapy alone group and 135 to the chemotherapy plus erlotinib group . The groups were balanced except for a higher proportion of patients with cholangiocarcinoma in the group given erlotinib than in the chemotherapy alone group ( 96 [ 71 % ] patients vs 84 [ 63 % ] ) . Median progression-free survival was 4·2 months ( 95 % CI 2·7 - 5·7 ) in the chemotherapy alone group and 5·8 months ( 95 % CI 4·6 - 7·0 ) in the chemotherapy plus erlotinib group ( hazard ratio [ HR ] 0·80 , 95 % CI 0·61 - 1·03 ; p=0·087 ) . Significantly more patients had an objective response in the chemotherapy plus erlotinib group than in the chemotherapy alone group ( 40 patients vs 21 patients ; p=0·005 ) , but median overall survival was the same in both groups ( 9·5 months [ 95 % CI 7·5 - 11·5 ] in the chemotherapy alone group and 9·5 months [ 7·6 - 11·4 ] in the chemotherapy plus erlotinib group ; HR 0·93 , 0·69 - 1·25 ; p=0·611 ) . All-cause deaths within 30 days of r and om assignment occurred in one ( 1 % ) of the patients in the chemotherapy alone group and in four ( 3 % ) of those in the chemotherapy plus erlotinib group . The most common grade 3 - 4 adverse event was febrile neutropenia ( eight [ 6 % ] patients in the chemotherapy alone group and six [ 4 % ] in the chemotherapy plus erlotinib group ) . No patient died of treatment-related causes during the study . Subgroup analyses by primary site of disease showed that for patients with cholangiocarcinoma , the addition of erlotinib to chemotherapy significantly prolonged median progression-free survival ( 5·9 months [ 95 % CI 4·7 - 7·1 ] for chemotherapy plus erlotinib vs 3·0 months [ 1·1 - 4·9 ] for chemotherapy alone ; HR 0·73 , 95 % CI 0·53 - 1·00 ; p=0·049 ) . INTERPRETATION Although no significant difference in progression-free survival was noted between groups , the addition of erlotinib to gemcitabine and oxaliplatin showed antitumour activity and might be a treatment option for patients with cholangiocarcinoma . FUNDING None Background A st and ard treatment for unresectable advanced-stage intrahepatic cholangiocarcinoma ( IHCC ) has not yet been established . Although neoadjuvant concurrent chemoradiotherapy ( CCRT ) and liver transplantation are associated with long-term survival in select patients , the outcomes of CCRT for advanced-stage unresectable IHCC remain unclear . The aim of our study was to evaluate the outcomes of CCRT in patients with unresectable advanced-stage IHCC . Methods We retrospectively review ed the records of all patients with unresectable advanced stage ( stage IVa or IVb ) IHCC who were pathologically diagnosed and treated at National Cancer Center , Korea , from June 2001 to March 2012 . Of the total of 92 patients , 25 ( 27.1 % ) received capecitabine plus cisplatin ( XP ) chemotherapy with external radiotherapy ( RT ) ( XP-CCRT group ) and 67 ( 72.8 % ) received XP chemotherapy alone ( XP group ) . The clinical characteristics and outcomes of the 2 groups were compared . Results The 92 patients comprised 72 male and 20 female patients , with a median age of 58 years ( range 26–78 years ) . The baseline clinical characteristics of the 2 groups were similar . Patients in the XP-CCRT group received a mean 44.7 Gy of RT and a mean 5.6 cycles of XP chemotherapy , whereas patients in the XP group received a mean 4.0 cycles . The disease control rate was higher in the XP-CCRT group than in the XP group , but the difference was not statistically significant ( 56.0 % vs. 41.5 % , p = 0.217 ) . Although neutropenia was significantly more frequent in the XP-CCRT than in the XP group ( 48 % vs. 9 % , p < 0.001 ) , the rates of other toxicities and > grade 3 toxicities did not differ . At a median follow-up of 5.3 months , PFS ( 4.3 vs. 1.9 months , p = 0.001 ) and OS ( 9.3 vs. 6.2 months , p = 0.048 ) were significantly longer in the XP-CCRT than in the XP group . Conclusions XP-CCRT was well tolerated and was associated with longer PFS and OS than XP chemotherapy alone in patients with unresectable advanced IHCC . Controlled r and omized trials are required to determine whether XP-CCRT is a primary treatment option for patients with unresectable advanced IHCC BACKGROUND / AIM Few clinical trials are available for advanced biliary tract carcinoma ( BTC ) . We conducted this r and omized phase II clinical trial to explore efficacy and safety of 5-fluorouracil/leucovorin ( 5-FU/LV - de Gramont ) or the same regimen plus oxaliplatin ( Folfox 4 ) as first-line treatment of advanced BTC . PATIENTS AND METHODS Primary endpoint was overall survival ( OS ) ; secondary endpoints were progression-free survival ( PFS ) , response and toxicity . RESULTS A total of 48 patients were enrolled , 23 in de Gramont arm and 25 in the Folfox arm . Disease control rate was 56.5 % for de Gramont vs. 72 % for Folfox . RR was 21.7 % for de Gramont arm and 28 % for Folfox arm ( p=0.12 ) . PFS was in favor of Folfox ( 5.2 vs. 2.8 months ; p=0.031 ) . OS was 7.5 and 13.0 months for de Gramont and Folfox arm respectively ( p=0.0010 ) . Toxicity was generally mild in both arms . CONCLUSION Folfox 4 could be considered a valid option as first-line treatment of BTC due to its efficacy and tolerability Background : A British r and omised study of gemcitabine plus cisplatin ( GC ) combination showed promising results in biliary tract cancer ( BTC ) patients . In our study , we evaluated the efficacy and safety of this combination compared with gemcitabine alone ( G ) in Japanese BTC patients . Methods : Overall , 84 advanced BTC patients were r and omised to either cisplatin 25 mg m−2 plus gemcitabine 1000 mg m−2 on days 1 , 8 of a 21-day cycle ( GC-arm ) , or single-agent gemcitabine 1000 mg m−2 on days 1 , 8 and 15 of a 28-day cycle ( G-arm ) . Treatments were repeated for at least 12 weeks until disease progression or unacceptable toxicity occurred , up to a maximum of 48 weeks . Results : A total of 83 patients were included in the analysis . For the GC and G-arms , respectively , the 1-year survival rate was 39.0 vs 31.0 % , median survival time 11.2 vs 7.7 months , median progression-free survival time 5.8 vs 3.7 months and overall response rate 19.5 vs 11.9 % . The most common grade 3 or 4 toxicities ( GC-arm/G-arm ) were neutropenia ( 56.1%/38.1 % ) , thrombocytopenia ( 39.0%/7.1 % ) , leukopenia ( 29.3%/19.0 % ) , haemoglobin decrease ( 36.6%/16.7 % ) and γ-GTP increase ( 29.3%/35.7 % ) . Conclusions : Gemcitabine plus cisplatin combination therapy was found to be effective and well tolerated , suggesting that it could also be a st and ard regimen for Japanese patients PURPOSE This study aim ed to establish an effective prognostic nomogram for intrahepatic cholangiocarcinoma ( ICC ) after partial hepatectomy . PATIENTS AND METHODS The nomogram was based on a retrospectively study on 367 patients who underwent partial hepatectomy for ICC at the Eastern Hepatobiliary Surgery Hospital from 2002 to 2007 . The predictive accuracy and discriminative ability of the nomogram were determined by concordance index ( C-index ) and calibration curve and compared with five currently used staging systems on ICC . The results were vali date d using bootstrap resampling and a prospect i ve study on 82 patients operated on from 2007 to 2008 at the same institution . RESULTS On multivariate analysis of the primary cohort , independent factors for survival were serum carcinoembryonic antigen , CA 19 - 9 , tumor diameter and number , vascular invasion , lymph node metastasis , direct invasion , and local extrahepatic metastasis , which were all selected into the nomogram . The calibration curve for probability of survival showed good agreement between prediction by nomogram and actual observation . The C-index of the nomogram for predicting survival was 0.74 ( 95 % CI , 0.71 to 0.77 ) , which was statistically higher than the C-index values of the following systems : American Joint Committee on Cancer ( AJ
Output:
| Conclusions : Folfox-4 regimen is likely to be the optimal chemotherapy for patients with advanced BTC and the predominant targeted therapy has n't achieved significant success currently .
XP and GS can be considered as alternatives for advanced BTC |
MS212950 | ***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 The need for lung protection is universally accepted , but the optimal level of positive end-expiratory pressure ( PEEP ) in patients with acute lung injury ( ALI ) or acute respiratory distress syndrome remains debated . OBJECTIVE To compare the effect on outcome of a strategy for setting PEEP aim ed at increasing alveolar recruitment while limiting hyperinflation to one aim ed at minimizing alveolar distension in patients with ALI . DESIGN , SETTING , AND PATIENTS A multicenter r and omized controlled trial of 767 adults ( mean [ SD ] age , 59.9 [ 15.4 ] years ) with ALI conducted in 37 intensive care units in France from September 2002 to December 2005 . INTERVENTION Tidal volume was set at 6 mL/kg of predicted body weight in both strategies . Patients were r and omly assigned to a moderate PEEP strategy ( 5 - 9 cm H(2)O ) ( minimal distension strategy ; n = 382 ) or to a level of PEEP set to reach a plateau pressure of 28 to 30 cm H(2)O ( increased recruitment strategy ; n = 385 ) . MAIN OUTCOME MEASURES The primary end point was mortality at 28 days . Secondary end points were hospital mortality at 60 days , ventilator-free days , and organ failure-free days at 28 days . RESULTS The 28-day mortality rate in the minimal distension group was 31.2 % ( n = 119 ) vs 27.8 % ( n = 107 ) in the increased recruitment group ( relative risk , 1.12 [ 95 % confidence interval , 0.90 - 1.40 ] ; P = .31 ) . The hospital mortality rate in the minimal distension group was 39.0 % ( n = 149 ) vs 35.4 % ( n = 136 ) in the increased recruitment group ( relative risk , 1.10 [ 95 % confidence interval , 0.92 - 1.32 ] ; P = .30 ) . The increased recruitment group compared with the minimal distension group had a higher median number of ventilator-free days ( 7 [ interquartile range { IQR } , 0 - 19 ] vs 3 [ IQR , 0 - 17 ] ; P = .04 ) and organ failure-free days ( 6 [ IQR , 0 - 18 ] vs 2 [ IQR , 0 - 16 ] ; P = .04 ) . This strategy also was associated with higher compliance values , better oxygenation , less use of adjunctive therapies , and larger fluid requirements . CONCLUSIONS A strategy for setting PEEP aim ed at increasing alveolar recruitment while limiting hyperinflation did not significantly reduce mortality . However , it did improve lung function and reduced the duration of mechanical ventilation and the duration of organ failure . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00188058 Twenty neonates requiring mechanical ventilation for respiratory failure , including 13 with hyaline membrane disease , were studied to assess the effects of alterations in ventilator setting s on mean airway pressure ( MAP ) , blood gases , and intracranial pressure ( ICP ) . The study involved r and om alterations in peak inspiratory pressure ( PIP ) , positive end-expiratory pressure ( PEEP ) , and inspiratory/expiratory ratio while MAP , PaO2 , ICP , and end-tibal PCO2 were continuously monitored . The results showed a significant relationship between MAP and PaO2 that was expressed as the change in PaO2 per millimeter of mercury change in MAP ( delta PaO2/delta MAP ) with a mean delta PaO2/delta MAP of 4.92 . The delta PaO2/delta MAP was highest for changes in PEEP ( 6.08 ) , followed by PIP ( 5.07 ) , and inspiratory/expiratory ratio ( 1.9 ) . There was a significant relationship between alterations in PEEP and PIP vs PaCO2 and pH. Increases in PEEP and decreases in PIP result ed in an elevated PaCO2 and a lowered pH , and decreases in PEEP and increases in PIP result ed in a decreased PaCO2 and an elevated pH. There was no significant relationship between MAP and ICP , but there was a significant association between delta ICP and delta PaCO2 during alterations in PIP ( r = .64 , P less than .001 ) . Increases in PEEP will lead to the greatest increase in PaO2 per change in MAP , followed by increase in PIP and inspiratory/expiratory ratio using a pressure-limited ventilator Abstract Positive end expiratory pressure is routinely used when ventilating preterm infants . Elevation of PEEP increases lung volume , as does surfactant treatment . The purpose of this study was to investigate the effect of various levels of PEEP within the range of 0.2 to 0.4 kPa on lung volume , compliance and gas exchange . We measured functional residual capacity , compliance of the respiratory system and arterial blood gases in 20 infants ( median birth weight 1240 g , range 660–1690 g ; median gestational age 28 weeks , range 24–32 weeks ; postnatal age 3–4 days ) . The infants were studied at 72 hours after their last dose of natural surfactant . At this time the patients were routinely nursed at 0.3 kPa of PEEP , the PEEP level was lowered to 0.2 kPa or raised to 0.4 kPa in r and om order . The PEEP level was then changed to the third level 0.4 kPa or 0.2 kPa . Each new setting was maintained for 20 min before FRC , compliance and blood gases were measured . FRC was assessed using SF6 washout technique . Increasing PEEP from 0.2 to 0.3 to 0.4 kPa result ed in increases in FRC ( p < 0.01 ) and oxygenation ( ns ) in all infants . In 16 infants compliance decreased and paCO2 increased with elevation of PEEP . Only in 4 infants compliance increased and CO2 fell . Conclusion : In the majority of our infants reduction of PEEP from 0.4 to 0.2 kPa result ed in increases in compliance and CO2 reduction . Our results might suggest that relatively low levels of PEEP < 0.3 kPa may be appropriate at 72 hours after surfactant replacement . Furthermore , these results underline the importance of PEEP test in clinical practice Sixteen rabbits were anaesthetized and subjected to saline lavage of the lungs to produce surfactant deficiency . This result ed in an arterial oxygen tension of less than 12 kPa on 100 % inspired oxygen and an inflection point on the pressure-volume curve at a pressure of 8–12 mmHg . After lavage the animals were r and omly assigned to receive either conventional mechanical ventilation ( CMV ) with a positive end-expiratory pressure ( PEEP ) of 1–2 mmHg ( group I —low PEEP ) or CMV with PEEP equal to the inflection point pressure ( group II — high PEEP ) . Mean airway pressures were kept at 14–16 mmHg in both groups by increasing the inspiratory : expiratory time ratios in the low PEEP group . The 5-h protocol was completed by 4 animals in group I and 6 animals in group II , early death usually being associated with a metabolic acidosis . On 100 % oxygen , the mean PaO2 at 2-h post-lavage was 15.2±8.3 kPa in group I and 39.6±21.8 kPa in group II . Group I had much lower end-expiratory lung volumes ( 3.0±1.5 ml above FRC ) than group II ( 34.9±12.2 ml above FRC ) . Histological examination of the lungs revealed significantly less hyaline membrane formation in group II ( p=0.001 ) . Thus , the prevention of alveolar collapse by the use of high PEEP levels appears to reduce lung damage in this preparation BACKGROUND There are limited data to inform the choice between early treatment with continuous positive airway pressure ( CPAP ) and early surfactant treatment as the initial support for extremely-low-birth-weight infants . METHODS We performed a r and omized , multicenter trial , with a 2-by-2 factorial design , involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation . Infants were r and omly assigned to intubation and surfactant treatment ( within 1 hour after birth ) or to CPAP treatment initiated in the delivery room , with subsequent use of a protocol -driven limited ventilation strategy . Infants were also r and omly assigned to one of two target ranges of oxygen saturation . The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks ( with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30 % oxygen ) . RESULTS A total of 1316 infants were enrolled in the study . The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group ( 47.8 % and 51.0 % , respectively ; relative risk with CPAP , 0.95 ; 95 % confidence interval [ CI ] , 0.85 to 1.05 ) after adjustment for gestational age , center , and familial clustering . The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks ( rates of primary outcome , 48.7 % and 54.1 % , respectively ; relative risk with CPAP , 0.91 ; 95 % CI , 0.83 to 1.01 ) . Infants who received CPAP treatment , as compared with infants who received surfactant treatment , less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia ( P<0.001 ) , required fewer days of mechanical ventilation ( P=0.03 ) , and were more likely to be alive and free from the need for mechanical ventilation by day 7 ( P=0.01 ) . The rates of other adverse neonatal outcomes did not differ significantly between the two groups . CONCLUSIONS The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants . ( Clinical Trials.gov number , NCT00233324 . A controlled trial of elective intervention with continuous inflating pressure ( CIP ) was performed in infants with severe hyaline membrane disease who weighed more than 1000 g at birth . Infants entered the trial if their arterial oxygen tension ( PaO2 ) fell below 60 mmHg while breathing a fractional inspired oxygen concentration ( F1O2 ) greater than 0 - 95 . 11 out of 12 infants in the CIP-treated group and 10 out of 12 in the control group survived . 7 treated and 6 control infants required mechanical ventilation . When CIP was started the Pao2 of the treated infants increased , and they breathed high concentrations of oxygen for a significantly shorter period than the control infants . During the 31-month duration of the trial 107 other infants with severe hyaline membrane disease were admitted who did not meet the criteria for entry to the trial . 37 survived after breathing high concentrations of oxygen ( F1O2 greater than 0 - 60 ) spontaneously without any ventilatory assistance , and the remaining 70 infants were already being ventilated on their arrival in the unit , usually because they had required mechanical ventilation during transfer from other hospitals . The neonatal survival rate for those infants born in this hospital during the study period was 88 % ( 50 out of 57 infants ) and for those referred from other hospitals it was 69 % ( 51 out of 74 infants ) . The maximum further increase in overall survival rate that might have been achieved in our population of infants if CIP had been initiated very early in the course of the illness was 5%--i.e . from 77 % ( 101/131 ) to 82 % ( 107/131 ) Objectives : To compare the effects of low vs. high tidal volume ( Vt ) with three positive end-expiratory pressure ( PEEP ) strategies on activated neutrophil influx into the lung . Design : Prospect i ve , r and omized controlled animal study . Setting : Animal laboratory in a university hospital . Subjects : Newborn piglets . Interventions : Surfactant-depleted piglets were r and omized in littermate pairs ; to PEEP of either 0 ( zero end-expiratory pressure [ ZEEP ] ; n = 6 ) , 8 cm H2O ( PEEP 8 ; n = 5 ) , or 1 cm H2O above the lower inflection point ( LIP ) ( PEEP > LIP ; n = 6 ) . Within each pair piglets were r and omized to a low Vt ( 5–7 mL/kg ) or high Vt strategy ( 17–19 mL/kg ) . After 4 hrs of mechanical ventilation , 18-fluorodeoxyglucose ( 18FDG ) was injected and positron emission tomography scanning was performed . Measurements and Main Results : Vt and PEEP changes on influx constants of 18FDG were assessed by analysis of variance . A within-litter comparison of Vt was nonsignificant ( p = .50 ) . A between-litter comparison , ordered in linear trend rank , from ZEEP , to PEEP 8 , to PEEP > LIP , showed a strong effect of PEEP on influx constant ( p = .019 ) . Conclusions : PEEP set above the LIP on the inspiratory limb of
Output:
| There is insufficient evidence to guide selection of appropriate PEEP levels for RDS or CMV . |
MS212951 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: OBJECTIVE To evaluate the therapeutic effects and safety of cefepime ( Maxipime ) and sulbactam/cefoperazone ( sulperazone ) on moderate and severe respiratory infection in children . METHODS Totally 100 children hospitalized for pneumonia were r and omized equally into 2 groups , namely group A with maxipime treatment at the dose of 50 mg/kg given intravenously twice daily , and group B with sulperazone treatment at 50 - 100 mg/kg given intravenously twice a day . The therapeutic effects and safety of both medications were observed . RESULTS In maxipime group , 44 of the 50 cases were cured with complete elimination of the symptoms and signs , and obvious therapeutic effect was achieved in 5 cases with significant improvement or resolution of the majority of symptoms and signs . One case failed to respond favorably to the treatment , with the overall efficacy rate of 98 % without incidence of adverse effects . In sulperazone group , 40 of the 50 cases were cured , 6 showed significant improvement , and 4 failed to respond to the treatment , with the rate of 92 % . One patient complained of rashes during sulperazone treatment , which disappeared the next day without sulperazone withdrawal . Significant difference was not noted between the groups ( chi(2)=2.43 , P>0.05 ) . CONCLUSIONS Both maxipime and sulperazon are effective and safe for application in children with moderate and severe respiratory infections BACKGROUND With the availability of new broad-spectrum antibiotics , initial therapy with a single agent has become an alternative to classic combinations , especially beta-lactam antibiotics plus aminoglycosides , in the management of febrile neutropenic cancer patients . PROCEDURE Since January 1994 , monotherapy has been used for empiric initial treatment at our center . The aim of this prospect i ve r and omized study is to compare the efficacy of cefepime ( CFP ) , a new fourth-generation cephalosporin , and ceftazidime ( CFZ ) as empirical monotherapy of febrile neutropenic patients with solid tumors . From January 1998 to November 1998 , 63 episodes of fever and neutropenia occurring in 33 children with solid tumors including lymphomas , were r and omized to receive treatment with either CFP or CFZ . The patients were analyzed for leukocyte count and absolute neutrophil count ( ANC ) at entry , days in fever , neutropenia and hospitalization , and side effects of drugs . Success with or without modifications of the initial antibiotic was defined as survival through neutropenia ; failure was death due to infection . RESULTS In our study group , with a median age of 7 [ (1/12)-14 ] years , CFP was administered in 32 , and CFZ in 31 episodes . An infection was documented microbiologically in eight episodes ( 25 % ) in the CFP arm and in nine episodes ( 29 % ) in the CFZ arm . The success rate with initial empiric monotherapy was 62.5 % in the CFP arm and 61.3 % in the CFZ arm respectively ( P > 0.05 ) . The total success rate ( success with or without modification ) was 100 % in both arms . No major adverse effects were observed in either groups . CONCLUSION CFP is as effective and safe as CFZ for the empirical treatment of febrile episodes in neutropenic patients with solid tumors A prospect i ve , open-label , r and omized , comparative study in pediatric cancer patients was conducted to evaluate the efficacy and safety of cefepime and meropenem in the empiric therapy of febrile neutropenic patients . Febrile episodes were classified as microbiologically documented infection , clinical documented infection , or fever of unknown origin . Clinical response to therapy was classified as success or failure . In this period 37 children with solid tumors including lymphoma , 25 males , 12 females , had neutropenia on 65 occasions . Microbiologically documented infections occurred in 21 episodes ( 32.31 % ) . Frequency of positive bacteria isolated was higher than gram-negative bacteria . There was no infection-related death . There were no statistical differences between the cefepime and meropenem groups for duration of fever or neutropenia , response rate , and necessity for modification . Cefepime appears to be as effective and safe as meropenem for empiric treatment of febrile episodes in neutropenic pediatric cancer patients Background . Monotherapy with cefepime or ceftazidime is an effective alternative to combination therapy for the treatment of febrile neutropenic adult cancer patients . We compared the efficacy and safety of cefepime and ceftazidime as empiric monotherapy of febrile neutropenia in children with cancer . Material s and methods . A prospect i ve , open label , r and omized , comparative study in pediatric cancer patients was conducted at Chang Gung Children ’s Hospital from January 1 , 2000 , to April 15 , 2001 . Patients with fever and neutropenia ( absolute neutrophil count of ≤500/mm3 ) were r and omized to receive either intravenous cefepime or ceftazidime ( 50 mg/kg/dose as two or three doses daily ) . Febrile episodes were classified as microbiologically documented infection , clinical ly documented infection or unexplained fever . Clinical response to therapy was classified as success and failure . Results . Ninety-five pediatric cancer patients with 120 febrile neutropenic episodes were r and omized to receive empiric treatment with cefepime or ceftazidime . After 72 h of treatment , 82.8 % ( 48 of 58 ) of the eligible patients in the cefepime group continued with unmodified therapy , compared with 87.9 % ( 51 of 58 ) in the ceftazidime group . The neutrophil count was < 100/mm3 at r and omization for 76 % of the patients in the cefepime group and 83 % of those in the ceftazidime group ; the median duration s of neutropenia ( < 500/mm3 ) were 8.5 and 6.5 days , respectively . Of the 96 evaluable episodes the overall success rate with unmodified empiric therapy until the end of the treatment course in the cefepime group was comparable with that in the ceftazidime group ( 69%vs . 71 % , P = 0.95 ) . The response rate after glycopeptides were added to the regimens was 79.2 % for the cefepime group and 77.1 % for the ceftazidime group . The bacterial eradication rate was 33 % for the cefepime group and 20 % for the ceftazidime group ( P = 0.85 ) , and the rates of new infections were 10.4%vs . 4.2 % ( P = 0.67 ) , respectively . Both study drugs were well-tolerated . Three ( 6.4 % ) patients in the cefepime group and 2 ( 4.3 % ) patients in the ceftazidime group died . Conclusion . Cefepime appeared to be as effective and safe as ceftazidime for empiric treatment of febrile episodes in neutropenic pediatric cancer patients 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 Abstract Multidrug-resistant organisms cause late-onset ventilator-associated pneumonia ( VAP ) . In a pilot , r and omized and controlled study , the efficacy and safety of cefepime , in late-onset VAP in infants , have now been evaluated in Malaysia . Thirty children aged < 1 year with late-onset VAP ( i.e. VAP occurring 5 or more days after intubation ) were r and omized to receive cefepime or , as a control , ceftazidime . The clinical responses and the microbiological clearance of tracheal aspirates were evaluated in each arm . Adverse events , if any , were monitored clinical ly and by blood tests . Ten of the 15 children given cefepime and five of the 15 given ceftazidime showed a satisfactory clinical response ( P<0.1 ) . Cefepime appeared significantly better at clearing polymicrobial infections from tracheal aspirates . There were no fatalities in the cefepime arm but three in ceftazidime ( P<0.1 ) . The mean ( S.E. ) duration s of antibiotic use were 9.4 ( 1.5 ) days for cefepime and 7.6 ( 1.0 ) days for ceftazidime ( P>0.05 ) . No serious adverse effects were observed in either arm . In conclusion , in late-onset VAP in infants , cefepime monotherapy appears to be at least as effective and safe as ceftazidime monotherapy , with better microbiological clearance The purpose of this study was to compare the efficacy , safety , and cost of piperacillin/tazobactam with cefepime monotherapy in children with febrile neutropenia . A prospect i ve r and omized study in children and adolescent with cancer was conducted . Patients were r and omly assigned to receive either 80 mg/kg piperacillin/10 mg/kg tazobactam every 6 h ( maximum 4.5 g/dose ) or cefepime 50 mg/kg every 8 h ( maximum 2 g/dose ) . Treatment modification was defined as all the changes in the empirical antimicrobials after the first 96 h. Overall treatment success was defined as cure of febrile episode with or without modification . Cost of hospitalization , antimicrobial drugs , and supportive therapy were calculated . Fifty febrile netropenic episodes ( 25 in the piperacillin/tazobactam group , 25 in the cefepime group ) in 27 pediatric cancer patients were evaluated . The groups were comparable in terms of age , gender , body weight , primary diagnosis , disease status , initial neutrophil count , and duration of neutropenia . Microbiologically and clinical ly documented infection rate was 46 % . There was no infection-related mortality in the study period . The treatment success of initial empirical therapy without modification was not different in the 2 groups ( 56 % in piperacillin/tazobactam group and 48 % in cefepime group ) . Anti-anaerobic drugs were added more frequently in the cefepime group . Duration of fever , neutropenia , treatment , and cost of therapy were not different in the treatment groups . Piperacillin/tazobactam monoterapy is as effective as cefepime monotherapy in febril neutropenia of pediatric cancer patients The efficacy , safety , and cost of cefepime and ceftazidime + amikacin as empirical therapy in children with febrile neutropenia is compared . A prospect i ve r and omized study in children with cancer was conducted . Patients were r and omly assigned to receive either cefepime 150 mg/kg/day or ceftazidime 150 mg/kg/day combined with amikacin 15 mg/kg/day . Treatment modification was defined as all the changes in the empirical antimicrobials after the first 72 h. Overall treatment success was defined as cure of febrile episode with or without modification . Costs of hospitalization , antimicrobial drugs , and supportive therapy were calculated . Fifty febrile netropenic episodes were evaluated . Infectious agents were microbiologically identified in 28 % of episodes . The incidence of gram-negative and gram-positive isolates was equal . Overall treatment success was 100 % and success of initial empirical therapy without modification was 52 and 40 % in the cefepime and cefepime + amikacin groups , respectively . The response rate after glycopeptides were added to the regimen was 64 and 52 % in the cefepime and cefepime + amikacin arms , respectively . Glycopeptide and antifungal drugs were added more frequently in the ceftazidime + amikacin group . Duration of fever , hospitalization , and antimicrobial drug administration were longer in the ceftazidime + amikacin arm . The costs of the antimicrobial drugs , hospitalization , and total cost were lower in the cefepime arm . Cefepime monotherapy is as effective as ceftazidime + amikacin combination in febrile neutropenia of pediatric cancer patients and must be preferred due to shorter defervescence of fever , shorter hospitalization , and lower therapy cost BACKGROUND Cefepime has been used in clinical therapeutic trials for meningitis , serious infection and febrile neutropenia , comprising more than 800 pediatric patients . This agent has also been used in patients 12 years of age and older with uncomplicated and complicated urinary tract infections including py
Output:
| This review , however , suggests that cefepime therapy in pediatric patients is not associated with an increased risk of adverse outcomes |
MS212952 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE The oral mammalian target of rapamycin inhibitor everolimus demonstrated promising efficacy in a phase II study of pretreated advanced gastric cancer . This international , double-blind , phase III study compared everolimus efficacy and safety with that of best supportive care ( BSC ) in previously treated advanced gastric cancer . PATIENTS AND METHODS Patients with advanced gastric cancer that progressed after one or two lines of systemic chemotherapy were r and omly assigned to everolimus 10 mg/d ( assignment schedule : 2:1 ) or matching placebo , both given with BSC . R and omization was stratified by previous chemotherapy lines ( one v two ) and region ( Asia v rest of the world [ ROW ] ) . Treatment continued until disease progression or intolerable toxicity . Primary end point was overall survival ( OS ) . Secondary end points included progression-free survival ( PFS ) , overall response rate , and safety . RESULTS Six hundred fifty-six patients ( median age , 62.0 years ; 73.6 % male ) were enrolled . Median OS was 5.4 months with everolimus and 4.3 months with placebo ( hazard ratio , 0.90 ; 95 % CI , 0.75 to 1.08 ; P = .124 ) . Median PFS was 1.7 months and 1.4 months in the everolimus and placebo arms , respectively ( hazard ratio , 0.66 ; 95 % CI , 0.56 to 0.78 ) . Common grade 3/4 adverse events included anemia , decreased appetite , and fatigue . The safety profile was similar in patients enrolled in Asia versus ROW . CONCLUSION Compared with BSC , everolimus did not significantly improve overall survival for advanced gastric cancer that progressed after one or two lines of previous systemic chemotherapy . The safety profile observed for everolimus was consistent with that observed for everolimus in other cancers OBJECTIVE We report the clinical features and management outcomes in 7 patients with everolimus-related stomatitis . STUDY DESIGN Fifteen women with hormone-receptor-positive advanced breast cancer receiving everolimus combined with exemestane were prospect ively evaluated to assess the development of stomatitis . Oral ulcers were diagnosed based on established criteria . RESULTS Seven patients developed stomatitis ( 46.6 % ) . All patients were treated with topical dexamethasone solution , while everolimus was temporarily discontinued in 4 patients . Stomatitis resolved within 1 - 2 weeks . Two of the 4 patients , who had interrupted everolimus , developed recurrent stomatitis following drug resume and everolimus was again discontinued and restarted after 2 weeks . To date , 5 patients receive everolimus in full dose . The 2 patients , who developed recurrent stomatitis , received a reduced dose . CONCLUSIONS Everolimus-related oral ulcers were frequent and led to dose modifications . Controlled trials , endorsing a consensus in terminology , are needed to evaluate measures on prevention and management of this unique toxicity BACKGROUND We tested the oral mammalian target of rapamycin ( mTOR ) inhibitor everolimus in addition to paclitaxel in patients with HER2-negative tumours not responding to initial neoadjuvant cytotoxic and anti-angiogenic treatment . METHODS Patients with primary HER2-negative tumours received four neoadjuvant cycles of epirubicin/cyclophosphamide ( EC ) with or without bevacizumab . Patients without clinical response were r and omised to receive weekly paclitaxel ( 80 mg/m(2 ) ) with or without everolimus ( 5 mg p.o . daily , after a step-wise dose-escalation starting from 2.5 mg bid ) for 12 weeks before surgery . To detect an increase in pathological complete response ( pCR ; ypT0 ypN0 ) from 5 % to 12.1 % ( odds ratio 2.62 ) 566 patients had to be recruited . The trial was stopped prematurely due to completion of accrual in the main study . FINDINGS Of 1948 patients initially starting neoadjuvant treatment 403 were r and omised . A total of 18 ( 4.6 % ) patients , 7 ( 3.6 % ) treated with paclitaxel and everolimus and 11 ( 5.6 % ) treated with paclitaxel alone had a pCR ( odds ratio 0.36 ( OR ) ( 95 % confidence interval ( CI ) , 0.24 - 1.6 ) p=0.34 ) . Overall response rate in breast and lymph nodes at surgery was 52.2 % after paclitaxel plus everolimus and 61.7 % after paclitaxel alone ( p=0.063 ) . Breast conserving treatment was performed in 54.4 % of patients with the combination treatment and 61.9 % with paclitaxel alone ( p=0.20 ) . Mucosal inflammation , thrombocytopenia , neutropenia , infection , and skin rash were more frequent when everolimus was added to paclitaxel . INTERPRETATION Neoadjuvant therapy with everolimus and paclitaxel for patients with HER2-negative disease unresponsive to EC with or without bevacizumab did not improve the pCR rate . Long-term outcome is awaited . FUNDING Novartis , Roche , and Sanofi-Aventis Anti-cancer agents that inhibit the mTOR pathway are associated with a number of unique toxicities , with one of the most significant and potentially dose-limiting being stomatitis . The objective of this study was to report the clinical features and management outcomes of a series of cancer patients who developed painful mTOR inhibitor-associated stomatitis ( mIAS ) . Seventeen cancer patients developed mIAS while being treated with everolimus- or ridaforolimus-containing protocol s at the Dana-Farber Cancer Institute and were referred to the oral medicine clinic for evaluation and management . Clinical characteristics , toxicity management , and outcomes were summarized . In addition , the frequency and rationale for dose reductions and therapy discontinuation were assessed . The median duration of mTOR inhibitor therapy was 80 days ( range 9 - 187 days ) . The median time to development of mouth ulcers was 10 days ( range 4 - 25 days ) . Five patients required protocol -directed dose reductions due to grade s 2 and 3 stomatitis and one patient discontinued cancer treatment due to mouth ulcers . Clinical improvement and pain relief was reported in 86.6 % of patients following topical , intralesional , or systemic corticosteroid therapy , with side effects limited to secondary c and idiasis ( n=2 ) . Mouth ulcers are a common and potentially dose limiting toxicity associated with the use of mTOR inhibitors in cancer treatment . This case series demonstrates that local and systemic corticosteroid therapy is an effective approach to managing patients with symptomatic mIAS . Prospect i ve studies are necessary to evaluate the effectiveness of treatment and prevention strategies with the ultimate goal of improving overall cancer treatment outcomes PURPOSE Cross-talk between the estrogen receptor ( ER ) and the phosphoinositide-3-kinase (PI3K)/Akt/mammalian target of rapamycin ( mTOR ) pathways is a mechanism of resistance to endocrine therapy , and blockade of both pathways enhances antitumor activity in pre clinical models . This study explored whether sensitivity to letrozole was enhanced with the oral mTOR inhibitor , everolimus ( RAD001 ) . PATIENTS AND METHODS Two hundred seventy postmenopausal women with operable ER-positive breast cancer were r and omly assigned to receive 4 months of neoadjuvant treatment with letrozole ( 2.5 mg/day ) and either everolimus ( 10 mg/day ) or placebo . The primary end point was clinical response by palpation . M and atory biopsies were obtained at baseline and after 2 weeks of treatment ( ie , day 15 ) . Sample s were assessed for PI3 K mutation status ( PIK3CA ) and for pharmacodynamic changes of Ki67 , phospho-S6 , cyclin D1 , and progesterone receptor ( PgR ) by immunohistochemistry . RESULTS Response rate by clinical palpation in the everolimus arm was higher than that with letrozole alone ( ie , placebo ; 68.1 % v 59.1 % ) , which was statistically significant at the preplanned , one-sided , alpha = 0.1 level ( P = .062 ) . Marked reductions in progesterone receptor and cyclin D1 expression occurred in both treatment arms , and dramatic downregulation of phospho-S6 occurred only in the everolimus arm . An antiproliferative response , as defined by a reduction in Ki67 expression to natural logarithm of percentage positive Ki67 of less than 1 at day 15 , occurred in 52 ( 57 % ) of 91 patients in the everolimus arm and in 25 ( 30 % ) of 82 patients in the placebo arm ( P < .01 ) . The safety profile was consistent with historical results of everolimus monotherapy ; grade s 3 to 4 adverse events occurred in 22.6 % of patients who received everolimus and in 3.8 % of patients who received placebo . CONCLUSION Everolimus significantly increased letrozole efficacy in neoadjuvant therapy of patients with ER-positive breast cancer BACKGROUND Interferon alfa is widely used for metastatic renal-cell carcinoma but has limited efficacy and tolerability . Temsirolimus , a specific inhibitor of the mammalian target of rapamycin kinase , may benefit patients with this disease . METHODS In this multicenter , phase 3 trial , we r and omly assigned 626 patients with previously untreated , poor-prognosis metastatic renal-cell carcinoma to receive 25 mg of intravenous temsirolimus weekly , 3 million U of interferon alfa ( with an increase to 18 million U ) subcutaneously three times weekly , or combination therapy with 15 mg of temsirolimus weekly plus 6 million U of interferon alfa three times weekly . The primary end point was overall survival in comparisons of the temsirolimus group and the combination-therapy group with the interferon group . RESULTS Patients who received temsirolimus alone had longer overall survival ( hazard ratio for death , 0.73 ; 95 % confidence interval [ CI ] , 0.58 to 0.92 ; P=0.008 ) and progression-free survival ( P<0.001 ) than did patients who received interferon alone . Overall survival in the combination-therapy group did not differ significantly from that in the interferon group ( hazard ratio , 0.96 ; 95 % CI , 0.76 to 1.20 ; P=0.70 ) . Median overall survival times in the interferon group , the temsirolimus group , and the combination-therapy group were 7.3 , 10.9 , and 8.4 months , respectively . Rash , peripheral edema , hyperglycemia , and hyperlipidemia were more common in the temsirolimus group , whereas asthenia was more common in the interferon group . There were fewer patients with serious adverse events in the temsirolimus group than in the interferon group ( P=0.02 ) . CONCLUSIONS As compared with interferon alfa , temsirolimus improved overall survival among patients with metastatic renal-cell carcinoma and a poor prognosis . The addition of temsirolimus to interferon did not improve survival . ( Clinical Trials.gov number , NCT00065468 [ Clinical Trials.gov ] . ) BACKGROUND Oral ulcers is a well-recognised adverse event ( AE ) of mTOR inhibitors . Paradoxically , little is known about its natural history , risk factors , and basic management . PATIENTS AND METHODS AEs of 79 patients prospect ively enrolled in 6 phase I-II studies testing everolimus were review ed . The following parameters were analysed : incidence , severity , duration and associated AE . The association between OU and everolimus dose , pharmacokinetics and the effectiveness of empiric treatments were explored . RESULTS OU , grade 3 - 4 OU , prolonged time under OU and RCOU ( recurrent and chronic oral ulcer ) were observed in 72 % 11 % , 30 % and 25 % patients , respectively . Patients with antecedent of prior chemotherapy , with PS 1 , or receiving everolimus in combination tended to present higher rates of prolonged time under OU and of grade 3 - 4 OU . As everolimus daily dose increased , the median time to OU was shorter , the median duration was longer and OU incidence tended to increase . Simultaneously , OU tended to be associated with higher everolimus exposure . None of the empiric treatments appeared effective against OU ( preventive or curative intent ) . CONCLUSION Everolimus-induced OU is a frequent , recurrent and sometimes harmful complication . A dose effect relationship is displayed . Its daily management remains challenging . OU represents a key issue in the compliance of mTOR inhibitors BACKGROUND Disease progression in patients with HER2-positive breast cancer receiving trastuzumab might be associated with activation of the PI3K/Akt/mTOR intracellular signalling pathway . We
Output:
| On subgroup analysis , there was no statistically significant difference between everolimus and temsirolimus in the risk of relevant adverse events .
CONCLUSIONS This meta- analysis demonstrated that regimens containing everolimus , temsirolimus or ridaforolimus for the treatment of solid tumors are associated with a significantly increased risk of all- grade and high- grade diarrhea and stomatitis . |
MS212953 | ***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: OBJECTIVES Treatment failure after radical prostatectomy is most commonly heralded by an increase in serum prostate-specific antigen ( PSA ) to detectable levels . We evaluated the clinical utility of an ultrasensitive chemiluminescent PSA assay . METHODS We evaluated the assay in banked sera obtained from 170 men after radical prostatectomy . Controls consisted of 142 females , 29 men who had undergone cystoprostatectomy without evidence of prostate cancer , and 25 men without evidence of recurrent disease at least 5 years after prostatectomy for organ-confined disease . Lead time to diagnosis of recurrence was based on comparisons with the IMx or T and em E assays using a cutoff of 0.1 ng/mL ( 100 pg/mL ) . RESULTS The biologic level of detection of this assay is 8 pg/mL. Serum PSA levels were undetectable in 82.4 % of females , 86.2 % of the cystoprostatectomy patients , and 96 % of the radical prostatectomy controls . After radical prostatectomy , PSA levels were undetectable at last check in 104 of 168 ( 61.9 % ) men . In the 24 men with prostate cancer recurrence , the enhanced sensitivity of 8 pg/mL provided a mean lead time based on conservative calculations of 12.7 to 22.5 months over conventional assays . Thirty-four of the 41 men with detectable PSA levels and no evidence of disease recurrence had PSA levels of 30 pg/mL or less . CONCLUSIONS PSA levels are undetectable in most men who do not have recurrence of disease after radical prostatectomy . Low but detectable serum PSA levels less than or equal to 30 pg/mL can be produced by nonmalignant sources of PSA . PSA assays with enhanced sensitivity can detect recurrent prostate cancer with significant lead time over conventional assays Objectives In this study , we evaluate the outcomes of salvage cryotherapy for locally recurrent prostate cancer within the COLD ( cryo online data ) Registry . Furthermore , we assess the results of salvage cryotherapy ( with intermediate follow-up ) stratified by pre-treatment prostate-specific antigen ( PSA ) levels to determine which patients may best be suited for treatment . Methods The COLD registry was developed as a prospect i ve , central ly collected data base among patients undergoing salvage cryoablation for locally recurrent prostate cancer following primary prostate radiotherapy with curative intent . Of the patients undergoing salvage cryotherapy ( without neoadjuvant hormonal ablative therapy ) , complete medical records were available in 156 patients , with their mean follow-up being 3.8 years ( 0.9–12.7 years ) . The treatment outcomes of salvage cryotherapy were assessed using the Phoenix definition ( nadir PSA + 2 ng/ml ) of biochemical failure . Results Of our entire study population , the biochemical disease-free survival ( bDFS ) rates at 1 , 2 , and 3 years were 89.0 , 73.7 , and 66.7 % , respectively . Stratification of our patients into two subgroups is based on their pre-treatment total serum PSA values < 5 and ≥5 ng/ml , and bDFS rates at 3 years for these two subgroups were 78.3 and 52.9 % , respectively . A Kaplan – Meier analysis of bDFS stratified by these same pre-treatment PSA values revealed that the subset of patients with a PSA ≥ 5 ng/ml had statistically significant poorer bDFS rates ( P = 0.01 ) . Conclusions Salvage prostate cryotherapy is a potentially curative local salvage therapy . The importance of early referral when patients have a pre-treatment PSA < 5 ng/ml is essential to optimize treatment outcomes PURPOSE High intensity focused ultrasound for the treatment of primary prostate cancer is increasing in a subset of men seeking definitive treatment with reduced morbidity . We review outcomes in men undergoing salvage radical prostatectomy after failed whole gl and high intensity focused ultrasound . MATERIAL S AND METHODS Prospect i ve data were collected for men presenting with an increasing prostate specific antigen and biopsy proven prostate cancer after high intensity focused ultrasound from 2007 to 2010 who underwent salvage open radical prostatectomy with a 22-month median followup , including prostate specific antigen , prostate volume , pathology results , continence and erectile function . RESULTS Data for 15 men were available , including median age 64 years ( IQR 55 - 69 ) , Gleason score before high intensity focused ultrasound of 6 ( 8) , Gleason score 7 ( 7 ) , median cores positive 39 % ( IQR 17%-63 % ) and median prostate specific antigen 7 ng/ml ( IQR 5 - 8 ) . Whole gl and high intensity focused ultrasound achieved median nadir prostate specific antigen 1.1 ng/ml ( IQR 0.5 - 3.1 ) . Biopsy after high intensity focused ultrasound demonstrated Gleason score 6 ( in 3 patients ) , 7 ( 9 ) and 8/9 ( 3 ) , and 42 % ( IQR 25%-50 % ) cores positive and a median time from high intensity focused ultrasound to radical prostatectomy of 22 months ( IQR 7 - 26 ) . Perioperative morbidity was limited to 1 transfusion in a patient with a rectal injury . Pathologically extensive periprostatic fibrosis was found with persistent prostate cancer , as pT3 disease ( in 9 of 14 ) , Gleason scores 6 ( 2 ) , 7 ( 9 ) and 8 of 9 ( 4 ) , with focally positive margins in 3 of 11 ( pT3a ) . Postoperative prostate specific antigen was unrecordable in 14 of 15 patients with further treatment in 2 . Postoperative continence ( more than 12 months of followup ) yielded no pad use in 6 of 10 men with universally poor erectile function . CONCLUSIONS Radical prostatectomy as salvage is feasible for men in whom high intensity focused ultrasound failed , but with a higher morbidity than for primary surgery . Pathology results are alarming given the number of cases with extraprostatic extension yet early followup data suggest acceptable oncologic control . These results should be factored in when counseling men who wish to undergo primary high intensity focused ultrasound CONTEXT Biochemical disease recurrence after radical prostatectomy often prompts salvage radiotherapy , but no studies to date have had sufficient numbers of patients or follow-up to determine whether radiotherapy improves survival , and if so , the subgroup of men most likely to benefit . OBJECTIVES To quantify the relative improvement in prostate cancer-specific survival of salvage radiotherapy vs no therapy after biochemical recurrence following prostatectomy , and to identify subgroups for whom salvage treatment is most beneficial . DESIGN , SETTING , AND PATIENTS Retrospective analysis of a cohort of 635 US men undergoing prostatectomy from 1982 - 2004 , followed up through December 28 , 2007 , who experienced biochemical and /or local recurrence and received no salvage treatment ( n = 397 ) , salvage radiotherapy alone ( n = 160 ) , or salvage radiotherapy combined with hormonal therapy ( n = 78 ) . MAIN OUTCOME MEASURE Prostate cancer-specific survival defined from time of recurrence until death from disease . RESULTS With a median follow-up of 6 years after recurrence and 9 years after prostatectomy , 116 men ( 18 % ) died from prostate cancer , including 89 ( 22 % ) who received no salvage treatment , 18 ( 11 % ) who received salvage radiotherapy alone , and 9 ( 12 % ) who received salvage radiotherapy and hormonal therapy . Salvage radiotherapy alone was associated with a significant 3-fold increase in prostate cancer-specific survival relative to those who received no salvage treatment ( hazard ratio [ HR ] , 0.32 [ 95 % confidence interval { CI } , 0.19 - 0.54 ] ; P<.001 ) . Addition of hormonal therapy to salvage radiotherapy was not associated with any additional increase in prostate cancer-specific survival ( HR , 0.34 [ 95 % CI , 0.17 - 0.69 ] ; P = .003 ) . The increase in prostate cancer-specific survival associated with salvage radiotherapy was limited to men with a prostate-specific antigen doubling time of less than 6 months and remained after adjustment for pathological stage and other established prognostic factors . Salvage radiotherapy initiated more than 2 years after recurrence provided no significant increase in prostate cancer-specific survival . Men whose prostate-specific antigen level never became undetectable after salvage radiotherapy did not experience a significant increase in prostate cancer-specific survival . Salvage radiotherapy also was associated with a significant increase in overall survival . CONCLUSIONS Salvage radiotherapy administered within 2 years of biochemical recurrence was associated with a significant increase in prostate cancer-specific survival among men with a prostate-specific antigen doubling time of less than 6 months , independent of other prognostic features such as pathological stage or Gleason score . These preliminary findings should be vali date d in other setting s , and ultimately , in a r and omized controlled trial PURPOSE Hormonal therapy ( HT ) is the current mainstay of systemic treatment for prostate specific antigen ( PSA ) only recurrence ( PSAR ) , however , there is virtually no published literature comparing HT to observation in the clinical setting . The goal of this study was to examine the Department of Defense Center for Prostate Disease Research observational data base to compare clinical outcomes in men who experienced PSAR after radical prostatectomy by early versus delayed use of HT and by a risk stratified approach . MATERIAL S AND METHODS Of 5,382 men in the data base who underwent primary radical prostatectomy ( RP ) , 4,967 patients were treated in the PSA-era between 1988 and December 2002 . Of those patients 1,352 men who had PSAR ( PSA after surgery greater than 0.2 ng/ml ) and had postoperative followup greater than 6 months were used as the study cohort . These patients were further divided into an early HT group in which patients ( 355 ) received HT after PSA only recurrence but before clinical metastasis and a late HT group for patients ( 997 ) who received no HT before clinical metastasis or by current followup . The primary end point was the development of clinical metastases . Of the 1,352 patients with PSAR clinical metastases developed in 103 ( 7.6 % ) . Patients were also stratified by surgical Gleason sum , PSA doubling time and timing of recurrence . Univariate and multivariate Cox proportional hazard models were used to evaluate the effect of early and late HT on clinical outcome . RESULTS Early HT was associated with delayed clinical metastasis in patients with a pathological Gleason sum greater than 7 or PSA doubling time of 12 months or less ( Hazards ratio = 2.12 , p = 0.01 ) . However , in the overall cohort early HT did not impact clinical metastases . Race , age at RP and PSA at diagnosis had no effect on metastasis-free survival ( p > 0.05 ) . CONCLUSIONS The retrospective observational multicenter data base analysis demonstrated that early HT administered for PSAR after prior RP was an independent predictor of delayed clinical metastases only for high-risk cases at the current followup . Further study with longer followup and r and omized trials are needed to address this important issue RADICALS is a large , international r and omised controlled trial addressing two of the most important questions in postoperative management after radical prostatectomy : the timing of postoperative radiotherapy ( immediate vs early salvage ) and the duration of hormone therapy ( none vs short term vs long term ) used in addition to prostate bed radiotherapy . It has been funded by the Clinical Trials Awards Advisory Committee and will be run by the Medical Research Council Clinical Trials Unit , in collaboration with the National Cancer Institute of Canada Clinical Trials Group and the Trial Management Group . Additional international collaborative groups are also being invited to take part . RADICALS is an ambitious trial , aim ing to recruit over 4000 patients . Widespread support from the urological and oncological communities will be required . More information relating to this study is available from the Medical Research Council Clinical Trials Unit via : [email protected] . © 2007 The Royal College of Radiologists PURPOSE Salvage radical prostatectomy is associated with a higher complication rate than radical prostatectomy without prior radiotherapy but the magnitude of the increase is not well delineated . MATERIAL S AND METHODS A total of 3,458 consecutive patients underwent open radical prostatectomy and 98 underwent open salvage radical prostatectomy from January 1999 to June 2007 . Data were collected from prospect i ve surgical and institutional morbidity data bases , and retrospectively from billing records and medical records . Medical and surgical complications were captured , grade d by the modified Clavien classification and classified by time of onset . RESULTS Median followup after salvage radical prostatectomy and radical prostatectomy was 34.5 and 45.5 months , respectively . Patients with salvage had significantly higher median age , modified Charlson comorbidity score , clinical and pathological stage , and Gleason score . They were less likely to have organ confined disease and more likely to have seminal vesicle invasion and nodal metastasis . There was no significant difference in median operative time , blood loss or transfusion rate . The salv
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| The most common option for local salvage therapy after radical prostatectomy ( RP ) was radiation .
Options for local salvage therapy after primary radiation included RP , brachytherapy , and cryotherapy .
Radiation therapy ( RT ) after RP can provide durable prostate-specific antigen ( PSA ) responses in a sizeable percentage of men , especially when given early ( ie , PSA < 1 ng/ml ) .
The role of salvage treatment after RT is less clear |
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Input: OBJECTIVES To study the feasibility and effectiveness of a discharge planning intervention . DESIGN Quasi-experimental pre-post study design . SETTING General medicine wards at three hospitals : an academic medical center , a community teaching hospital , and a community-based nonteaching hospital . PARTICIPANTS All patients aged 65 and older admitted to the hospitalist services . INTERVENTION The intervention toolkit had five core elements : admission form with geriatric cues , facsimile to the primary care provider , interdisciplinary worksheet to identify barriers to discharge , pharmacist-physician collaborative medication reconciliation , and predischarge planning appointments . MEASUREMENTS Thirty-day readmission and return to emergency department rates and patient satisfaction with discharge . Odds ratios were determined , and site effects were examined accordig to interaction terms and Breslow Day statistics . RESULTS Two hundred thirty-seven patients were followed during the preintervention period , and 185 were exposed to the intervention . Patients characteristics were similar across the two time periods . The proportion of patients with high- quality transitions home , measured according to Coleman 's Care Transition Measures , increased from 68 % to 89 % ( odds ratio (OR)=3.49 , 95 % confidence interval (CI)=2.06 - 5.92 ) . Return to the emergency department within 3 days of discharge was lower in the intervention period ( 10 % vs 3 % , OR=0.25 , 95 % CI=0.10 - 0.62 ) . At 30 days , there was a lower rate of readmission ( 22 % vs 14 % , OR=0.59 , 95 % CI=0.34 - 0.97 ) and fewer visits to the emergency department ( 21 % vs 14 % , OR=0.61 , 95 % CI=0.36 - 1.03 ) ( P=.06 ) . CONCLUSION When hospitalized elderly patients are treated with consideration of their specific needs , healthcare outcomes can be improved 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 BACKGROUND Prior studies suggest that unintended medication discrepancies that represent errors are common at the time of hospital admission . These errors are particularly worthy of attention because they are not likely to be detected by computerized physician order entry systems . METHODS We prospect ively studied patients reporting the use of at least 4 regular prescription medications who were admitted to general internal medicine clinical teaching units . The primary outcome was unintended discrepancies ( errors ) between the physicians ' admission medication orders and a comprehensive medication history obtained through interview . We also evaluated the potential seriousness of these discrepancies . All discrepancies were review ed with the medical team to determine if they were intentional or unintentional . All unintended discrepancies were rated for their potential to cause patient harm . RESULTS After screening 523 admissions , 151 patients were enrolled based on the inclusion criteria . Eighty-one patients ( 53.6 % ; 95 % confidence interval , 45.7%-61.6 % ) had at least 1 unintended discrepancy . The most common error ( 46.4 % ) was omission of a regularly used medication . Most ( 61.4 % ) of the discrepancies were judged to have no potential to cause serious harm . However , 38.6 % of the discrepancies had the potential to cause moderate to severe discomfort or clinical deterioration . CONCLUSIONS Medication errors at the time of hospital admission are common , and some have the potential to cause harm . Better methods of ensuring an accurate medication history at the time of hospital admission are needed BACKGROUND Clinical ly important medication errors are common after hospital discharge . They include preventable or ameliorable adverse drug events ( ADEs ) , as well as medication discrepancies or nonadherence with high potential for future harm ( potential ADEs ) . OBJECTIVE To determine the effect of a tailored intervention on the occurrence of clinical ly important medication errors after hospital discharge . DESIGN R and omized , controlled trial with concealed allocation and blinded outcome assessors . ( Clinical Trials.gov registration number : NCT00632021 ) SETTING Two tertiary care academic hospitals . PATIENTS Adults hospitalized with acute coronary syndromes or acute decompensated heart failure . INTERVENTION Pharmacist-assisted medication reconciliation , inpatient pharmacist counseling , low-literacy adherence aids , and individualized telephone follow-up after discharge . MEASUREMENTS The primary outcome was the number of clinical ly important medication errors per patient during the first 30 days after hospital discharge . Secondary outcomes included preventable or ameliorable ADEs , as well as potential ADEs . RESULTS Among 851 participants , 432 ( 50.8 % ) had 1 or more clinical ly important medication errors ; 22.9 % of such errors were judged to be serious and 1.8 % life-threatening . Adverse drug events occurred in 258 patients ( 30.3 % ) and potential ADEs in 253 patients ( 29.7 % ) . The intervention did not significantly alter the per-patient number of clinical ly important medication errors ( unadjusted incidence rate ratio , 0.92 [ 95 % CI , 0.77 to 1.10 ] ) or ADEs ( unadjusted incidence rate ratio , 1.09 [ CI , 0.86 to 1.39 ] ) . Patients in the intervention group tended to have fewer potential ADEs ( unadjusted incidence rate ratio , 0.80 [ CI , 0.61 to 1.04 ] ) . LIMITATION The characteristics of the study hospitals and participants may limit generalizability . CONCLUSION Clinical ly important medication errors were present among one half of patients after hospital discharge and were not significantly reduced by a health-literacy-sensitive , pharmacist-delivered intervention . PRIMARY FUNDING SOURCE National Heart , Lung , and Blood Institute Background : Internal hospital transfer is a vulnerable time during which patients are at high risk of medication discrepancies that can result in clinical ly significant harm , medication errors , and adverse drug events . Objective : To identify , characterize , and assess the clinical impact of unintentional medication discrepancies during internal hospital transfer and to investigate the influence of computerized prescriber order entry ( CPOE ) on medication discrepancies . Methods : All patients transferred between 10 inpatient units at 2 tertiary care hospitals were prospect ively assessed to identify discrepancies . Interfaces included transfers between ( 1 ) units that both used paper-based medication ordering systems ; ( 2 ) units that both used CPOE-based systems ; and ( 3 ) units that used both paper-based and CPOE-based systems ( hybrid transfer ) . The primary endpoint was the number of patients with at least 1 unintentional medication discrepancy during internal hospital transfer . Discrepancies were identified through assessment and comparison of a best possible medication transfer list with the actual transfer orders . A multidisciplinary team of clinicians assessed the potential clinical impact and severity of unintentional discrepancies . Results : Overall , 190 patients were screened and 129 patients were included . Eighty patients ( 62.0 % ) had at least 1 unintentional medication discrepancy at the time of transfer , and the most common discrepancy was medication omission ( 55.6 % ) . Factors that independently increased the risk of a patient experiencing at least 1 unintentional discrepancy included lack of best possible medication history , increasing number of home medications , and increasing number of transfer medications . Forty-seven patients ( 36.4 % ) had at least 1 unintentional discrepancy with the potential to cause discomfort and /or clinical deterioration . The risk of discrepancies was present regardless of the medication-ordering system ( paper , CPOE , or hybrid ) . Conclusions : Clinical ly significant medication discrepancies occur commonly during internal hospital transfer . A structured , collaborative , and clearly defined medication reconciliation process is needed to prevent internal transfer discrepancies and patient harm Background Medication reconciliation has been m and ated by the Irish government at transfer of care . Research is needed to determine the contribution of clinical pharmacists to the process . Objective To describe the contribution of emergency department based clinical pharmacists to admission medication reconciliation in Irel and . Main Outcome Measure Frequency of clinical pharmacist ’s activities . Setting Two public university teaching hospitals . Methodology Adults admitted via the accident and emergency department , from a non-acute setting , reporting the use of at least three regular prescription medications , were eligible for inclusion . Medication reconciliation was provided by clinical pharmacists to r and omly-selected patients within 24-hours of admission . This process includes collecting a gold-st and ard pre-admission medication list , checking this against the admission prescription and communicating any changes . A discrepancy was defined as any difference between the gold-st and ard pre-admission medication list and the admission prescription . Discrepancies were communicated to the clinician in the patient ’s healthcare record . Potentially harmful discrepancies were also communicated verbally . Pharmacist activities and unintentional discrepancies , both resolved and unresolved at 48-hours were measured . Unresolved discrepancies were confirmed verbally by the team as intentional or unintentional . A reliable and vali date d tool was used to assess clinical significance by medical consultants , clinical pharmacists , community pharmacists and general practitioners . Results In total , 134 patients , involving 1,556 medications , were included in the survey . Over 97 % of patients ( involving 59 % of medications ) experienced a medication change on admission . Over 90 % of patients ( involving 29 % of medications ) warranted clinical pharmacy input to determine whether such changes were intentional or unintentional . There were 447 interventions by the clinical pharmacist regarding apparently unintentional discrepancies , a mean of 3.3 per patient . In total , 227 ( 50 % ) interventions were accepted and discrepancies resolved . At 48-hours under half ( 46 % ) of patients remained affected by an unintentional unresolved discrepancy ( 60 % related to omissions ) . Verbally communicated discrepancies were more likely to be resolved than those not communicated verbally ( Chi-square ( 1 ) = 30.029 p < 0.05 ) . Under half of unintentional unresolved discrepancies ( 46 % ) had the potential to cause minor harm compared to 70 % of the resolved unintentional discrepancies . None had the potential to result in severe harm . Conclusion Clinical pharmacists contribute positively to admission medication reconciliation and should be engaged to deliver this service in Irel and Objective : This study aim ed to evaluate the use of a shared electronic primary health care record ( EHR ) to assist with medicines reconciliation in the hospital from admission to discharge . Methods : This is a prospect i ve cross-sectional , comparison evaluation for 2 phases , in a short-term elderly admissions ward in the United Kingdom . In phase 1 , full reconciliation of the medication history was attempted , using conventional methods , before accessing the EHR , and then the EHR was used to verify the reconciliation . In phase 2 , the EHR was the initial method of retrieving the medication history-vali date d by conventional methods . Results : Where reconciliation was led by conventional methods , and before any access to the EHR was attempted , 28 ( 28 % ) of hospital prescriptions were found to contain errors . Of 99 prescriptions subsequently checked using the EHR , only 50 ( 50 % ) matched the EHR . Of the remainder , 25 % of prescriptions contained errors when verified by the EHR . However , 26 % of patients had an incorrect list of current medications on the EHR . Using the EHR as the primary method of reconciliation , 33 ( 32 % ) of 102 prescriptions matched the EHR . Of those that did not match , 39 ( 38 % ) of prescriptions
Output:
| However , there was no significant reduction in either the proportion of patients with medication discrepancies or the mean number of discrepancies per patient .
Conclusion Medication reconciliation supported by an electronic tool was able to minimize the incidence of medications with unintended discrepancy , mainly drug omissions . |
MS212955 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: BACKGROUND To compare capecitabine/cisplatin with 5-fluorouracil/cisplatin as first-line treatment for advanced gastric cancer ( AGC ) . PATIENTS AND METHODS In this r and omised , open-label , phase III study , patients received cisplatin ( 80 mg/m(2 ) i.v . day 1 ) plus oral capecitabine ( 1000 mg/m(2 ) b.i.d . , days 1 - 14 ) ( XP ) or 5-FU ( 800 mg/m(2)/day by continuous infusion , days 1 - 5 ) ( FP ) every 3 weeks . The primary end point was to confirm noninferiority of XP versus FP for progression-free survival ( PFS ) . RESULTS A total of 316 patients were r and omised to XP ( n = 160 ) or FP ( n = 156 ) . In the per- protocol population , median PFS for XP ( n = 139 ) versus FP ( n = 137 ) was 5.6 versus 5.0 months . The primary end point was met with an unadjusted hazard ratio ( HR ) of 0.81 [ 95 % confidence interval ( CI ) 0.63 - 1.04 , P < 0.001 versus noninferiority margin of 1.25 ] . Median overall survival was 10.5 versus 9.3 months for XP versus FP ( unadjusted HR = 0.85 , 95 % CI 0.64 - 1.13 , P = 0.008 versus noninferiority margin of 1.25 ) . The most common treatment-related grade 3/4 adverse events in XP versus FP patients were as follows : neutropenia ( 16 % versus 19 % ) , vomiting ( 7 % versus 8 % ) , and stomatitis ( 2 % versus 6 % ) . CONCLUSIONS XP showed significant noninferiority for PFS versus FP in the first-line treatment of AGC . XP can be considered an effective alternative to FP Summary This was a phase II study of capecitabine in substitution of 5-fluorouracil ( 5-FU ) in the chemoradiotherapy regimen for patients with localized squamous cell carcinoma of the anal canal . Background Combined chemoradiation with infusional 5-FU and mitomycin is the st and ard treatment for localized squamous cell carcinoma ( SCC ) of the anal canal . Capecitabine is an oral fluoropirimidine that has been shown to be equally effective to 5-FU in many solid tumors . However , the efficacy of the substitution of 5-FU for capecitabine in anal SCC needs confirmation . Methods Patients with SCC of anal cancer T2 - 4N0M0 or T ( any ) N1 - 3M0 , with good performance status and normal blood and renal function , were treated with capecitabine 825 mg/m2 bid during radiotherapy associated with a single dose of mitomycin 15 mg/m2 on day 1 . The primary objective was local control rate at 6 months determined by clinical examination and radiological assessment . Sample size was calculated using the Fleming single-stage design . Results From November 2010 to February 2014 , N = 51 patients were initially included ; however , 43 patients were assessed . Seventeen patients ( 39.5 % ) were stage II , 11 patients ( 25.6 % ) stage IIIA , and 15 patients ( 34.9 % ) stage IIIB . Four patients ( 9.3 % ) were HIV positive . With a median follow-up of 23.1 months ( range 4 to 44.4 months ) , 3 patients ( 7 % ) presented partial response , 37 ( 86 % ) had complete response , and 3 patients developed progression of the disease ( 7 % ) at 6 months . The colostomy rate was 18.6 % . It was observed a locoregional control of 86 % in 6 months ( CI 95 % 0.72–0.94 ) . The main grade 3–4 toxicities were grade 3 radiodermitis in 10 patients ( 23.2 % ) , grade 3 lymphopenia in 5 patients ( 11.6 % ) , and grade 3 neutropenia in 2 patients ( 6.9 % ) . One HIV-positive patient had septic shock , pneumonia , herpetic encephalitis , atrial fibrillation , and macrophage activation syndrome . Conclusions Capecitabine can safely substitute infusional 5-FU in the st and ard chemoradiation regimen for SCC of the anal cancer , with a locoregional control of 86 % in 6 months ( CI 95 % 0.72–0.94 ) PURPOSE On initial publication of GI Intergroup Radiation Therapy Oncology Group ( RTOG ) 98 - 11 [ A Phase III R and omized Study of 5-Fluorouracil ( 5-FU ) , Mitomycin , and Radiotherapy Versus 5-Fluorouracil , Cisplatin and Radiotherapy in Carcinoma of the Anal Canal ] , concurrent chemoradiation ( CCR ) with fluorouracil ( FU ) plus mitomycin ( MMC ) decreased colostomy failure ( CF ) when compared with induction plus concurrent FU plus cisplatin ( CDDP ) , but did not significantly impact disease-free survival ( DFS ) or overall survival ( OS ) for anal canal carcinoma . The intent of the up date d analysis was to determine the long-term impact of treatment on survival ( DFS , OS , colostomy-free survival [ CFS ] ) , CF , and relapse ( locoregional failure [ LRF ] , distant metastasis ) in this patient group . PATIENTS AND METHODS Stratification factors included sex , clinical node status , and primary size . DFS and OS were estimated univariately by the Kaplan-Meier method , and treatment arms were compared by log-rank test . Time to relapse and CF were estimated by the cumulative incidence method and treatment arms were compared by using Gray 's test . Multivariate analyses used Cox proportional hazard models to test for treatment differences after adjusting for stratification factors . RESULTS Of 682 patients accrued , 649 were analyzable for outcomes . DFS and OS were statistically better for RT + FU/MMC versus RT + FU/CDDP ( 5-year DFS , 67.8 % v 57.8 % ; P = .006 ; 5-year OS , 78.3 % v 70.7 % ; P = .026 ) . There was a trend toward statistical significance for CFS ( P = .05 ) , LRF ( P = .087 ) , and CF ( P = .074 ) . Multivariate analysis was statistically significant for treatment and clinical node status for both DFS and OS , for tumor diameter for DFS , and for sex for OS . CONCLUSION CCR with FU/MMC has a statistically significant , clinical ly meaningful impact on DFS and OS versus induction plus concurrent FU/CDDP , and it has borderline significance for CFS , CF , and LRF . Therefore , RT + FU/MMC remains the preferred st and ard of care PURPOSE To investigate the potential gain of the concomitant use of radiotherapy and chemotherapy in improving local control and reducing the need for colostomy , a r and omized phase III trial was performed in patients with locally advanced anal cancer . MATERIAL S AND METHODS From 1987 to 1994 , 110 patients were r and omized between radiotherapy alone and a combination of radiotherapy and chemotherapy . The patients had T3 - 4NO-3 or T1 - 2N1 - 3 anal cancer . Radiotherapy consisted of 45 Gy given in 5 weeks , with a daily dose of 1.8 Gy . After a rest period of 6 weeks , a boost of 20 or 15 Gy was given in case of partial or complete response , respectively . Surgical resection as part of the primary treatment was performed if possible in patients who had not responded 6 weeks after 45 Gy or with residual palpable disease after the completion of treatment . Chemotherapy was given during radiotherapy : 750 mg/m2 daily fluorouracil as a continuous infusion on days 1 to 5 and 29 to 33 , and a single dose of mitomycin 15 mg/m2 administered on day 1 . RESULTS The addition of chemotherapy to radiotherapy result ed in a significant increase in the complete remission rate from 54 % for radiotherapy alone to 80 % for radiotherapy and chemotherapy , and from 85 % to 96 % , respectively , if results are considered after surgical resections . This led to a significant improvement of locoregional control and colostomy-free interval ( P = .02 and P = .002 , respectively ) , both in favor of the combined modality treatment . The locoregional control rate improved by 18 % at 5 years , while the colostomy-free rate at that time increased by 32 % by the addition of chemotherapy to radiotherapy . No significant difference was found when severe side effects were considered , although anal ulcers were more frequently observed in the combined-treatment arm . The survival rate remained similar in both treatment arms . Skin ulceration , nodal involvement , and sex were the most important prognostic factors for both local control and survival . These remained significant after multivariate analysis . The improvement seen in local control by adding chemotherapy to radiotherapy also remained significant after adjusting for prognostic factors in the multivariate analysis . Event-free survival , defined as free of locoregional progression , no colostomy , and no severe side effects or death , showed significant improvement ( P = .03 ) in favor of the combined-treatment modality . The 5-year survival rate was 56 % for the whole patient group . CONCLUSION The concomitant use of radiotherapy and chemotherapy result ed in a significantly improved locoregional control rate and a reduction of the need for colostomy in patients with locally advanced anal cancer without a significant increase in late side effects CONTEXT Chemoradiation as definitive therapy is the preferred primary therapy for patients with anal canal carcinoma ; however , the 5-year disease-free survival rate from concurrent fluorouracil/mitomycin and radiation is only approximately 65 % . OBJECTIVE To compare the efficacy of cisplatin-based ( experimental ) therapy vs mitomycin-based ( st and ard ) therapy in treatment of anal canal carcinoma . DESIGN , SETTING , AND PARTICIPANTS US Gastrointestinal Intergroup trial RTOG 98 - 11 , a multicenter , phase 3 , r and omized controlled trial comparing treatment with fluorouracil plus mitomycin and radiotherapy vs treatment with fluorouracil plus cisplatin and radiotherapy in 682 patients with anal canal carcinoma enrolled between October 31 , 1998 , and June 27 , 2005 . Stratifications included sex , clinical nodal status , and tumor diameter . INTERVENTION Participants were r and omly assigned to 1 of 2 intervention groups : ( 1 ) the mitomycin-based group ( n = 341 ) , who received fluorouracil ( 1000 mg/m2 on days 1 - 4 and 29 - 32 ) plus mitomycin ( 10 mg/m2 on days 1 and 29 ) and radiotherapy ( 45 - 59 Gy ) or ( 2 ) the cisplatin-based group ( n = 341 ) , who received fluorouracil ( 1000 mg/m2 on days 1 - 4 , 29 - 32 , 57 - 60 , and 85 - 88 ) plus cisplatin ( 75 mg/m2 on days 1 , 29 , 57 , and 85 ) and radiotherapy ( 45 - 59 Gy ; start day = day 57 ) . MAIN OUTCOME MEASURES The primary end point was 5-year disease-free survival ; secondary end points were overall survival and time to relapse . RESULTS A total of 644 patients were assessable . The median follow-up for all patients was 2.51 years . Median age was 55 years , 69 % were women , 27 % had a tumor diameter greater than 5 cm , and 26 % had clinical ly positive nodes . The 5-year disease-free survival rate was 60 % ( 95 % confidence interval [ CI ] , 53%-67 % ) in the mitomycin-based group and 54 % ( 95 % CI , 46%-60 % ) in the cisplatin-based group ( P = .17 ) . The 5-year overall survival rate was 75 % ( 95 % CI , 67%-81 % ) in the mitomycin-based group and 70 % ( 95 % CI , 63%-76 % ) in the cisplatin-based group ( P = .10 ) . The 5-year local-regional recurrence and distant metastasis rates were 25 % ( 95 % CI , 20%-30 % ) and 15 % ( 95 % CI , 10%-20 % ) , respectively , for mitomycin-based treatment and 33 % ( 95 % CI , 27%-40 % ) and 19 % ( 95 % CI , 14%-24 % ) , respectively , for cisplatin-based treatment . The cumulative rate of colostomy was significantly better for mitomycin-based than cisplatin-based treatment ( 10 % vs 19 % ; P = .
Output:
| Capecitabine is an acceptable and more convenient alternative to infusional 5-FU in the CRT for localised SCCAC , offering similar clinical CRR to those reported by phase-III trials |
MS212956 | ***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 double-blind study of 537 patients evaluated the relative efficacy of four drugs — chlordiazepoxide , chlorpromazine , hydroxyzine , and thiamine — commonly used in treating alcohol withdrawal symptoms , specifically to prevent delirium tremens and convulsions . Of the 55 patients who developed these symptoms , two percent were in the chlordiazepoxide group ; the incidence ranged from ten to 16 percent in the other treatment groups . The authors conclude that chlordiazepoxide appears to be the drug of choice among those tested Zuclopenthixol acetate — a new injectable formulation with a duration of action of 2–3 days — was compared with conventional intramuscular and oral formulations of haloperidol and zuclopenthixol in the initial treatment of acutely disturbed , psychotic patients . The patients were stratified into 3 diagnostic categories : acute psychoses ( 48 patients ) , mania ( 22 patients ) , and exacerbation of chronic psychoses ( 73 patients ) . The patients were rated on the Brief Psychiatric Rating Scale ( BPRS ) , the Bech‐Rafaelsen Mania Rating Scale ( brmas ) ( only manic patients ) and globally on the Clinical Global Impression ( CGI ) . The study was an open , r and omized multicentre trial with a 6‐day treatment period . The zuclopenthixol acetate patients received 1–4 doses , the haloperidol patients 1–26 and the zuclopenthixol patients 1–22 doses . The assessment s on the CGI showed that all 3 treatments caused a clear reduction of the severity of illness scores in all 3 diagnostic categories , with no differences between treatments . The ratings of the acute and chronic psychotic patients on the BPRS also showed significant reductions in scores with no differences between treatments . All 3 treatments caused a rapid remission of symptoms on the BRMAS . Haloperidol induced hypokinesia in significantly more patients than zuclopenthixol acetate after 24 h. Later there were no significant differences between treatments . Zuclopenthixol acetate fulfils many desires for an amended neuroleptic formulation for the initial treatment of acutely disturbed psychotic patients In an 18 hospital study , 205 patients hospitalized with a diagnosis of manic-depressive illness , manic type , were treated upon discharge with lithium carbonate or placebo for a two-year period . Lithium carbonate was significantly more effective than placebo in preventing relapses ( ie , affective episodes severe enough to require hospitalization or use of non study drugs ) . The difference in treatment outcome between lithium carbonate and placebo was due mainly to the lower incidence of manic relapses on lithium carbonate . Patients on lithium carbonate also had a lower incidence of depressive relapses than patients on placebo but the limited incidence of severe depression in this sample makes it difficult to draw any conclusions regarding the prophylactic efficacy of lithium carbonate in depressive illness . The results from this trial coupled with those from other studies indicate that lithium carbonate combined with regular clinical appraisal s is a safe and effective treatment for preventing relapse in manic-depressive illness The merits or otherwise of publishing hospital specific death rates are much debated . This article compares the relative sensitivity of measures of process and outcome to differences in quality of care for the hospital treatment of myocardial infa rct ion . Aspects of hospital care that have a proved impact on mortality from myocardial infa rct ion are identified , and the results from meta- analysis and large r and omised controlled trials are used to estimate the impact that optimal use of these interventions would have on mortality in a typical district general hospital . Sample size calculations are then performed to determine how many years of data would be needed to detect significant differences between hospitals . A comparison is then made with the amount of data that would be needed to detect significant differences if information about process of care was being collected . Process measures based on the results of r and omised controlled trials were found to be able to detect relevant differences between hospitals that would not be identified by comparing hospital specific mortality , which is an insensitive indicator of the quality of care Abstract Objectives : To estimate the proportion of interventions in general practice that are based on evidence from clinical trials and to assess the appropriateness of such an evaluation . Design : Retrospective review of case notes . Setting : One suburban training general practice . Subjects : 122 consecutive doctor-patient consultations over two days . Main outcome measures : Proportions of interventions based on r and omised controlled trials ( from literature search with Medline , pharmaceutical data bases , and st and ard textbooks ) , on convincing non-experimental evidence , and without substantial evidence . Results : 21 of the 122 consultations recorded were excluded due to insufficient data ; 31 of the interventions were based on r and omised controlled trial evidence and 51 based on convincing non-experimental evidence . Hence 82/101 ( 81 % ) of interventions were based on evidence meeting our criteria . Conclusions : Most interventions within general practice are based on evidence from clinical trials , but the methods used in such trials may not be the most appropriate to apply to this setting . Key messages Key messages 81 % of general practice can be described as evidence based using this method of assessment Evidence derived from different method ologies may be important for the assessment of the evidence base of general The phenylpiperidine derivative paroxetine is a selective serotonin reuptake inhibitor . In a double-blind 6-week trial , paroxetine was compared with amitriptyline in hospitalized patients suffering from major depression ( DSM-III ) . One hundred fifty-three patients were enrolled in the study in seven centers in Austria and Germany . Results showed similar efficacy of both drugs after 6 weeks . The differences between groups in Mont-gomery-Asberg Depression Rating Scale and Clinical Global Impression ratings did not reach statistical significance at any time . Side effects were distributed similarly but with a significantly higher incidence of anticholinergic effects in patients treated with amitriptyline ( p < 0.001 ) , whereas agitation and insomnia were registered more often in the paroxetine group . This study supports the antidepressive efficacy of paroxetine in a sample of severely depressed in patients BACKGROUND This study was design ed to establish whether ( as suggested in a number of open and relatively small controlled trials ) lithium augmentation is more effective than continued antidepressant alone , where response to a st and ard course of antidepressant treatment has been absent or partial . METHOD Lithium or placebo was added on a double-blind basis for six weeks to the drug regime of 62 patients with major depressive illness ( in both hospital and primary care setting s ) who had failed to respond to a controlled trial of fluoxetine or lofepramine . Response was defined as a final Hamilton Depression Rating Scale ( HDRS ) score of < 10 . RESULTS Response was seen more frequently in patients taking lithium ( 15/29 ) than in those remaining on antidepressant alone ( 8/32 ; P or = 0.4 mmol/l ) . No differences in the efficacy of LA were apparent between fluoxetine and lofepramine . CONCLUSIONS Our results confirm that LA is a useful strategy in the treatment of antidepressant-resistant depression . Partial response was , however , frequently observed with continued antidepressant treatment alone , and the superiority of LA appears to depend on achieving adequate serum lithium levels For many years clinicians have had to cope with the accusation that only 10 - 20 % of the treatments they provide have any scientific foundation . Their interventions , in other words , are seldom " evidence based " . Is the profession guilty as charged ? In April , 1995 , a general medical team at a university-affiliated district hospital in Oxford , UK , studied the treatments given to all 109 patients managed during that month on whom a diagnosis had been reached . Medical sources ( including data bases ) were then search ed for r and omised controlled trial ( RCT ) evidence that the treatments were effective . The 109 primary treatments were then classified : 82 % were evidence based ( ie , there was RCT support [ 53 % ] or unanimity on the team about the existence of convincing non-experimental evidence [ 29 % ] ) . This study , which needs to be repeated in other clinical setting s and for other disciplines , suggests that earlier pessimism over the extent to which evidence -based medicine is already practised is misplaced OBJECTIVE The purpose of this study was to investigate the safety and efficacy of risperidone in the treatment of schizophrenic patients and determine its optimal dose . METHOD This double-blind study included 388 schizophrenic patients drawn from 20 sites in the United States . Patients were r and omly assigned to 8 weeks ' treatment with placebo , one of four doses of risperidone ( 2 , 6 , 10 , or 16 mg ) , or 20 mg of haloperidol daily . RESULTS Clinical improvement ( 20 % reduction in total scores on the Positive and Negative Syndrome Scale for Schizophrenia ) at the study end point was shown by 35 % of the patients receiving 2 mg of risperidone , 57 % receiving 6 mg , 40 % receiving 10 mg , and 51 % receiving 16 mg ; and by 30 % receiving haloperidol and 22 % receiving placebo . Statistically significant differences in clinical improvement were found between 6 and 16 mg of risperidone versus placebo and versus haloperidol . Positive symptom scores were significantly lower after 6 , 10 , and 16 mg of risperidone and 20 mg of haloperidol than placebo ; negative symptom scores , however , were reduced significantly , compared with placebo , only after 6 and 16 mg of risperidone . The incidence of extra-pyramidal side effects ( measured by the Extrapyramidal Symptom Rating Scale ) was significantly higher in patients treated with 16 mg of risperidone or 20 mg of haloperidol than placebo . The results indicate that the optimal daily dose of risperidone for most schizophrenic patients in this study was 6 mg ; this dose was as effective as 16 mg , and the incidence of extrapyramidal symptoms in patients receiving 6 mg of risperidone was no higher than that in patients receiving placebo . CONCLUSIONS Risperidone is a safe antipsychotic that is effective against both the positive and negative symptoms of schizophrenia
Output:
| MAIN OUTCOME MEASURES : Primary interventions were classified according to whether or not they were supported by evidence from r and omised controlled trials or systematic review s. RESULTS : The primary interventions received by 26/40 ( 65 % ; 95 % confidence interval ( 95 % CI ) 51 % to 79 % ) of patients admitted during the period were based on r and omised trials or systematic review s. CONCLUSIONS : When patients were used as the denominator , most primary interventions given in acute general psychiatry were based on experimental evidence . |
MS212957 | ***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 course and outcome of DSM-III-R anxiety disorders prospect ively in clinical ly referred children . METHOD Children were blindly and repeatedly assessed with a structured diagnostic interview over a 3- to 4-year period to determine recovery from anxiety disorder and development of new psychiatric disorders . Both psychopathological ( attention-deficit hyperactivity disorder , n = 50 ) and never psychiatrically ill ( NPI , n = 83 ) controls served as comparison groups for children with anxiety disorders ( n = 84 ) . RESULTS The majority of children ( 82 % ) were free from their intake anxiety disorders by the end of the follow-up . Relapse of these anxiety disorders after remission was rare ( 8 % ) . During follow-up , anxious children were more likely to develop new psychiatric disorders ( 30 % ) , primarily new anxiety disorders ( 16 % ) , than were NPI children ( 11 % and 2 % , respectively ) , but not psychopathological controls ( 42 % and 10 % , respectively ) . CONCLUSIONS Overall , results suggest a favorable outcome with respect to diagnostic status for clinical ly referred children with anxiety disorders . However , these children may be at risk for new psychiatric disorders over time Background Although literature provides support for cognitive behavioral therapy ( CBT ) as an efficacious intervention for social phobia , more research is needed to improve treatments for children . Methods Forty four Caucasian children ( ages 8 - 14 ) meeting diagnostic criteria of social phobia according to the Diagnostic and Statistical Manual of Mental Disorders ( 4th ed . ; APA , 1994 ) were r and omly allocated to either a newly developed CBT program focusing on cognition according to the model of Clark and Wells ( n = 21 ) or a wait-list control group ( n = 23 ) . The primary outcome measure was clinical improvement . Secondary outcomes included improvements in anxiety coping , dysfunctional cognitions , interaction frequency and comorbid symptoms . Outcome measures included child report and clinican completed measures as well as a diagnostic interview . Results Significant differences between treatment participants ( 4 dropouts ) and controls ( 2 dropouts ) were observed at post test on the German version of the Social Phobia and Anxiety Inventory for Children . Furthermore , in the treatment group , significantly more children were free of diagnosis than in wait-list group at post-test . Additional child completed and clinician completed measures support the results . Discussion The study is a first step towards investigating whether CBT focusing on cognition is efficacious in treating children with social phobia . Future research will need to compare this treatment to an active treatment group . There remain the questions of whether the effect of the treatment is specific to the disorder and whether the underlying theoretical model is adequate . Conclusion Preliminary support is provided for the efficacy of the cognitive behavioral treatment focusing on cognition in socially phobic children . Active comparators should be established with other evidence -based CBT programs for anxiety disorders , which differ significantly in their dosage and type of cognitive interventions from those of the manual under evaluation ( e.g. Coping Cat ) Abstract Objective To examine the extent and nature of outcome reporting bias in a broad cohort of published r and omised trials . Design Retrospective review of publications and follow up survey of authors . Cohort All journal articles of r and omised trials indexed in PubMed whose primary publication appeared in December 2000 . Main outcome measures Prevalence of incompletely reported outcomes per trial ; reasons for not reporting outcomes ; association between completeness of reporting and statistical significance . Results 519 trials with 553 publications and 10 557 outcomes were identified . Survey responders ( response rate 69 % ) provided information on unreported outcomes but were often unreliable — for 32 % of those who denied the existence of such outcomes there was evidence to the contrary in their publications . On average , over 20 % of the outcomes measured in a parallel group trial were incompletely reported . Within a trial , such outcomes had a higher odds of being statistically non-significant compared with fully reported outcomes ( odds ratio 2.0 ( 95 % confidence interval 1.6 to 2.7 ) for efficacy outcomes ; 1.9 ( 1.1 to 3.5 ) for harm outcomes ) . The most commonly reported reasons for omitting efficacy outcomes included space constraints , lack of clinical importance , and lack of statistical significance . Conclusions Incomplete reporting of outcomes within published articles of r and omised trials is common and is associated with statistical non- significance . The medical literature therefore represents a selective and biased subset of study outcomes , and trial protocol s should be made publicly available This study evaluated the effectiveness of cognitive-behavioral treatment for childhood anxiety in a community clinic setting in Hong Kong , China . Forty-five clinical ly-referred children ( age 6 - 11 years ) were r and omly assigned to either a cognitive-behavioral treatment program or a waitlist-control condition . Children in the treatment condition showed significant reduction in anxiety symptoms-both statistically and clinical ly-whereas children in the waitlist condition did not . After the waitlist period was over , the control group also received the treatment program and showed a similar reduction in symptoms . For the full sample of 45 children , the effectiveness of the intervention was significant immediately after treatment and in 3- and 6-month follow-ups . In addition , children 's anxiety cognition and their ability to cope with anxiety-provoking situations fully mediated the treatment gains . These results offer empirical support for cognitive-behavioral treatment programs in a non-Western cultural context and plausible mediators for how cognitive-behavioral therapy works OBJECTIVE A pilot study to evaluate the efficacy of a cognitive-behavioral group therapy program for adolescents with social phobia , simplified both in terms of time and labor intensity from a previously studied program ( Social Effectiveness Therapy for Children and Adolescents ) to be more appropriate for a community outpatient psychiatric setting . METHOD Twelve adolescents with social phobia ( ages 13 - 18 ) , diagnosed by DSM-IV criteria and confirmed with Anxiety Disorders Interview Schedule for Children assessment , were r and omly assigned to treatment ( n=6 ) and waitlist ( n=6 ) groups . The waitlist group was subsequently treated , and results were included in the data analysis . Assessment s , including Anxiety Disorders Interview Schedule for Children interviews and self-report Social Phobia and Anxiety Inventory and Beck Depression Inventory II question naires , were performed at baseline and immediately after treatment or waitlist . RESULTS All subjects completed the treatment program . Compared with the waitlist group , treated subjects showed significantly greater improvement in both examiner-evaluated ( Anxiety Disorders Interview Schedule for Children ) and self-reported ( Social Phobia and Anxiety Inventory ) symptoms of social anxiety ( effect sizes [ d ] , 1.63 and 0.85 , respectively ) . No significant change was seen in Beck Depression Inventory II scores for treatment or waitlist groups . CONCLUSIONS This study provides support for the use of simplified cognitive-behavioral interventions for adolescents with social phobia that are practical for community psychiatric setting The study examined the shape of therapeutic alliance using latent growth curve modeling and data from multiple informants ( therapist , child , mother , father ) . Children ( n = 86 ) with anxiety disorders were r and omized to family-based cognitive-behavioral treatment ( FCBT ; N = 47 ) with exposure tasks or to family education , support , and attention ( FESA ; N = 39 ) . Children in FCBT engaged in exposure tasks in Sessions 9 - 16 , whereas FESA participants did not . Alliance growth curves of FCBT and FESA youths were compared to examine the impact of exposure tasks on the shape of the alliance ( between-subjects ) . Within FCBT , the shape of alliance prior to exposure tasks was compared with the shape of alliance following exposure tasks ( within-subjects ) . Therapist , child , mother , and father alliance ratings indicated significant growth in the alliance across treatment sessions . Initial alliance growth was steep and subsequently slowed over time , regardless of the use of exposure tasks . Data did not indicate a rupture in the therapeutic alliance following the introduction of in-session exposures . Results are discussed in relation to the processes , mediators , and ingredients of efficacious interventions as well as in terms of the dissemination of empirically supported treatments BACKGROUND Children with high-functioning autism spectrum disorders ( ASD ) are at high risk for developing significant anxiety . Anxiety can adversely impact functioning across school , home and community environments . Cognitive behavioral therapies ( CBT ) are frequently used with success for children with anxiety symptoms . Modified CBT interventions for anxiety in children with ASD have also yielded promising results . METHODS Fifty children with high-functioning ASD and anxiety were r and omizedto group CBT or treatment-as-usual ( TAU ) for 12 weeks . Independent clinical evaluators , blind to condition , completed structured interviews ( Anxiety Disorders Interview Schedule – Parent Version;ADIS-P ) pre- and post-intervention condition . RESULTS Forty-seven children completed either the CBT or TAU condition . Results indicated markedly better outcomes for the CBT group . Significant differences by group were noted in Clinician Severity Ratings , diagnostic status , and clinician ratings of global improvement . In the intent-to-treat sample , 10 of 20 children ( 50 % ) in the CBT group had a clinical ly meaningful positive treatment response , compared to 2 of 23 children ( 8.7 % ) in the TAU group . CONCLUSIONS Initial results from this r and omized , design ed treatment study suggest that agroup CBT intervention specifically developed for children with ASD may be effective in decreasing anxiety . Limitations of this study include small sample size , lack of an attention control group , and use of outcome measures normed with typically developing BACKGROUND Promising evidence has emerged of clinical gains using guided self-help cognitive-behavioural therapy ( CBT ) for child anxiety and by involving parents in treatment ; however , the efficacy of guided parent-delivered CBT has not been systematic ally evaluated in UK primary and secondary setting s. AIMS To evaluate the efficacy of low-intensity guided parent-delivered CBT treatments for children with anxiety disorders . METHOD A total of 194 children presenting with a current anxiety disorder , whose primary carer did not meet criteria for a current anxiety disorder , were r and omly allocated to full guided parent-delivered CBT ( four face-to-face and four telephone sessions ) or brief guided parent-delivered CBT ( two face-to-face and two telephone sessions ) , or a wait-list control group ( trial registration : IS RCT N92977593 ) . Presence and severity of child primary anxiety disorder ( Anxiety Disorders Interview Schedule for DSM-IV , child/parent versions ) , improvement in child presentation of anxiety ( Clinical Global Impression - Improvement scale ) , and change in child anxiety symptoms ( Spence Children 's Anxiety Scale , child/parent version and Child Anxiety Impact scale , parent version ) were assessed at post-treatment and for those in the two active treatment groups , 6 months post-treatment . RESULTS Full guided parent-delivered CBT produced superior diagnostic outcomes compared with wait-list at post-treatment , whereas brief guided parent-delivered CBT did not : at post-treatment , 25 ( 50 % ) of those in the full guided CBT group had recovered from their primary diagnosis , compared with 16 ( 25 % ) of those on the wait-list ( relative risk ( RR ) 1.85 , 95 % CI 1.14 - 2.99 ) ; and in the brief guided CBT group , 18 participants ( 39 % ) had recovered from their primary diagnosis post-treatment ( RR = 1.56 , 95 % CI 0.89 - 2.74 ) . Level of therapist training and experience was unrelated to child outcome . CONCLUSIONS Full guided parent-delivered CBT is an effective and inexpensive first-line treatment for child anxiety Twenty-three preadolescent children ( ages 8 - 11 ) meeting criteria for social phobia were r and omly assigned to either a 3-week cognitive-behavioral group intervention or a wait-list control group . The intervention consisted of psychoeducation , cognitive strategies , and behavioral exposure . Outcome measures included diagnostic interview as well as parent and child report measures of anxiety and depression . Improvements were observed at posttest , with results stronger for parent report and interviewer ratings than for child self-report . At 3-week follow-up , children receiving the intervention demonstrated significant improvements on the majority of child , parent , and interviewer reports of social anxiety and related symptoms relative to wait-list participants . Preliminary support is provided for the utility of a brief intervention for preadolescent children with social phobia . Limitations and implication s for future research are discussed OBJECTIVE Most tests of cognitive behavioral therapy ( CBT ) for youth anxiety disorders have shown beneficial effects , but these have been efficacy trials with recruited youths treated by research er-employed therapists . One previous ( nonr and omized ) trial in community clinics found that CBT did not outperform usual care ( UC ) . The present study used a more stringent effectiveness design to test CBT versus UC in youths referred to community clinics , with all treatment provided by therapists employed in the clinics . METHOD A r and omized controlled trial methodology was used . Therapists were r and omized to training and supervision in the Coping Cat CBT program or UC . Forty-eight youths ( 56 % girls , 8 to 15 years of age , 38 % Caucasian , 33 % Latino , 15 % African-American ) diagnosed with DSM-IV anxiety disorders were r and omized to CBT
Output:
| Cognitive behavioural therapy is an effective treatment for childhood and adolescent anxiety disorders ; however , the evidence suggesting that CBT is more effective than active controls or TAU or medication at follow-up , is limited and inconclusive |
MS212958 | ***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: Objectives To assess a 2-year family-based behavioural intervention programme against child obesity . Design Single-group pre- and post-intervention feasibility study . Setting Swedish paediatric outpatient care . Participants 26 obese children aged 8.3–12.0 years and their parents who had consented to actively participate in a 2-year intervention . Interventions 25 paediatric outpatient group sessions over a 2-year period with parallel groups for children and parents . The basis for the programme was a manual containing instructions for tutor-supervised group sessions with obese children and their parents . Primary and secondary outcome measures The primary outcome measure was change in st and ardised body mass index between baseline and after 36 months . The secondary outcome measures were change in the waist : height ratio , metabolic parameters and programme adherence . The participants were examined at baseline and after 3 , 12 and 24 months of therapy and at follow-up 12 months after completion of the programme . Results The primary outcome measure , st and ardised body mass index , declined from a mean of 3.3 ( 0.7 SD ) at baseline to 2.9 ( 0.7 SD ) ( p<0.001 ) at follow-up 12 months after completion of the programme . There was no change in the waist : height ratio . Biomedical markers of blood glucose metabolism and lipid status remained in the normal range . 96 % of the families completed the programme . Conclusions This feasibility study of a 2-year family-based behavioural intervention programme in paediatric outpatient care showed promising results with regard to further weight gain and programme adherence . These findings must be confirmed in a r and omised controlled trial with longer follow-up before the intervention programme can be implemented on a larger scale OBJECTIVE The objective was to compare targeting increased eating of healthy foods vs. reducing intake of high energy-dense foods within the context of a family-based behavioral weight control program . METHODS AND PROCEDURES Forty-one 8 - 12 year-old children > 85th BMI percentile were r and omly assigned to a 24-month family-based behavioral treatment that targeted increasing fruits and vegetables and low-fat dairy vs. reducing intake of high energy-dense foods . RESULTS Children in the increase healthy food group showed greater reduction in z BMI compared to children in the reduce high energy-dense food group at 12- ( -0.30 z BMI units vs. -0.15 z BMI units , P = 0.01 ) and 24- ( -0.36 z BMI units vs -0.13 z BMI units , P = 0.04 ) month follow-up . Parents in the increase healthy food group showed greater reductions in concern about child weight ( P = 0.007 ) , and these changes were associated with child z BMI change ( P = 0.008 ) . Children in the reduce high energy-dense group showed larger sustained reductions in high energy-dense foods ( P < 0.05 ) . Baseline levels of high energy-dense foods ( P < 0.05 ) , parent food restraint ( P = 0.01 ) , parent concern over parent weight ( P = 0.01 ) and parent acceptance of the child ( P < 0.05 ) moderated child z BMI change , with greater sustained reductions in z BMI for children in the increase healthy food group for each measure . Parent z BMI change followed the same pattern as child changes , and parent and child z BMI changes were correlated ( P < 0.001 ) . DISCUSSION Focusing on healthy food choices within an energy restricted diet may be useful in family-based weight control programs OBJECTIVE . The objective of this study was to determine whether a generalizable best- practice individualized behavioral intervention reduced BMI z score relative to st and ard dietetic care among overweight children . METHODS . The design consisted of an assessor-blinded , r and omized , controlled trial involving 134 overweight children ( 59 boys , 75 girls ; BMI ≥ 98th centile relative to United Kingdom 1990 reference data for children aged 5–11 years ) who were r and omly assigned to a best- practice behavioral program ( intervention ) or st and ard care ( control ) . The intervention used family-centered counseling and behavioral strategies to modify diet , physical activity , and sedentary behavior . BMI z score , weight , objective ly measured physical activity and sedentary behavior , fat distribution , quality of life , and height z score were recorded at baseline and at 6 and 12 months . RESULTS . The intervention had no significant effect relative to st and ard care on BMI z score from baseline to 6 months and 12 months . BMI z score decreased significantly in both groups from baseline to 6 and 12 months . For those who complied with treatment , there was a significantly smaller weight increase in those in the intervention group compared with control subjects from baseline to 6 months . There were significant between-group differences in favor of the intervention for changes in total physical activity , percentage of time spent in sedentary behavior , and light-intensity physical activity . CONCLUSIONS . A generalizable , best- practice individualized behavioral intervention had modest benefits on objective ly measured physical activity and sedentary behavior but no significant effect on BMI z score compared with st and ard care among overweight children . The modest magnitude of the benefits observed perhaps argues for a longer-term and more intense intervention , although such treatments may not be realistic for many health care systems Background In 2005 , we reported on the success of Comprehensive School Health ( CSH ) in improving diets , activity levels , and body weights . The successful program was recognized as a " best practice " and has inspired the development of the Alberta Project Promoting active Living and healthy Eating ( APPLE ) Schools . The project includes 10 schools , most of which are located in socioeconomically disadvantaged areas . The present study examines the effectiveness of a CSH program adopted from a " best practice " example in another setting by evaluating temporal changes in diets , activity levels and body weight . Methods In 2008 and 2010 , we surveyed grade 5 students from approximately 150 r and omly selected schools from the Canadian province of Alberta and students from 10 APPLE Schools . Students completed the Harvard Youth/Adolescent Food Frequency Question naire , questions on physical activity , and had their height and weight measured . Multilevel regression methods were used to analyze changes in diets , activity levels , and body weight between 2008 and 2010 . Results In 2010 relative to 2008 , students attending APPLE Schools were eating more fruits and vegetables , consuming fewer calories , were more physically active and were less likely obese . These changes contrasted changes observed among students elsewhere in the province . Conclusions These findings provide evidence on the effectiveness of CSH in improving health behaviors . They show that an example of " best practice " may lead to success in another setting . Herewith the study provides the evidence that investments for broader program implementation based on " best practice " are justified Background —The prevalence of obesity in both adults and children is increasing rapidly . Obesity in children is independently associated with arterial endothelial dysfunction and wall thickening , key early events in atherogenesis that precede plaque formation . Methods and Results —To evaluate the reversibility of obesity-related arterial dysfunction and carotid intima-media thickening by dietary and /or exercise intervention programs , 82 overweight children ( body mass index , 25±3 ) , 9 to 12 years of age , were r and omly assigned to dietary modification only or diet plus a supervised structured exercise program for 6 weeks and subsequently for 1 year . The prospect ively defined primary end points were ultrasound-derived arterial endothelial function ( endothelium-dependent dilation ) of the brachial artery and intima-media thickness of common carotid artery . At 6 weeks , both interventions were associated with decreased waist-hip ratio ( P < 0.02 ) and cholesterol level ( P < 0.05 ) as well as improved arterial endothelial function . Diet and exercise together were associated with a significantly greater improvement in endothelial function than diet alone ( P = 0.01 ) . At 1 year , there was significantly less thickening of the carotid wall ( P < 0.001 ) as well as persistent improvements in body fat content and lipid profiles in the group continuing an exercise program . Vascular function was significantly better in those children continuing exercise ( n=22 ) compared with children who withdrew from the exercise program ( n=19 ) ( P < 0.05 ) . Conclusions —Obesity-related vascular dysfunction in otherwise healthy young children is partially reversible with diet alone or particularly diet combined with exercise training at 6 weeks , with sustained improvements at 1 year in those persisting with diet plus regular exercise Background : The program The combined DAK therapy for obesity in children and adolescents ’ funded and conducted by the Deutsche Angestellten-Krankenkasse ( DAK ) , a German health insurance company , commenced in 2003 . The treatment program lasts for 1 year and comprises of 2 phases : an initial inpatient therapy for 6 weeks followed by a home-based outpatient treatment of the overweight children , adolescents , and their families for 10.5 months . The therapy complies with the guidelines of the German Working Group of Obesity in Childhood and Adolescence ( AGA ) . Participants and Methods : In this study , 162 obese children and adolescents were compared with a control group of 75 obese subjects recruited from the waiting list for the program . The aim was to analyze whether the changes in weight , eating behavior , and physical fitness during the therapy period are a result of the therapy itself or whether they are attributable to external effects . Body weight , height , and physical fitness were assessed through direct measurements while behavior and quality of life were assessed using self-report question naires . The development of body weight was evaluated using the BMI -SDS which is a measure of how many st and ard deviations an individual BMI is above or below the age- and gender-specific mean . Results : Within the observation period the BMI SDS decreased significantly by 0.36 ± 0.34 in the intervention group , whereas no changes of BMI -SDS were observed in the control group ( 0.04 ± 0.17 ) . The study revealed significant , positive treatment effects in exploratory analyses with regard to weight loss , behavior changes , physical fitness , and development of quality of life as a result of the therapy . These effects were not seen in the control group . Conclusion : We conclude that these positive developments are a result of the treatment program PURPOSE To determine the effect of increasing the aerobic component of the school 's physical activity program and improving the knowledge about weight control and blood pressure on the blood pressure and body fat of early adolescents . METHODS The subjects were 1140 youth aged 11 to 14 years ( 630 females , 510 males ; 64 % white , 24.4 % African-American , and 11.6 % " other " ) , who were r and omly assigned by school into four treatment groups : exercise only , education only , exercise and education combined , and control group . Heights , weights , and skinfold thicknesses were measured , and body mass index ( BMI ) was computed kg/m(2 ) . Blood pressure was obtained in duplicate using a r and om-zero mercury sphygmomanometer . Maximal oxygen uptake was predicted from a submaximal cycle ergometer test . Data were analyzed using analysis of covariance statistics , adjusting for gender , ethnicity , age , socioeconomic status , and initial baseline characteristics . RESULTS Systolic and diastolic blood pressures increased more in the control group than in the intervention groups ( p = .001 ) . The BMI did not change significantly ( p = .709 ) , but the sum of skinfolds increased less in subjects in the exercise intervention groups than the education only or control groups ( p = .0001 ) . The small increase in (p)VO(2)max of the combined exercise and education group was significantly greater than the education only group ( p = .0001 ) . CONCLUSION An exercise program for youth can have a positive effect on blood pressure independent of body weight loss Increasing fruits and vegetables ( FVs ) , a dietary recommendation for pediatric weight management , is theorized to reduce energy intake by reducing intake of more energy-dense foods , such as snack foods ( SFs ) . This study examined the relationship between changes in FV , SF , and energy intake in children enrolled in a 6-month , family-based behavioral pediatric weight management trial . Secondary data analyses examined dietary intake in 80 overweight ( ≥85th to < 95th percentile for body mass index [ BMI ] ) and obese ( ≥95th percentile for BMI ) children ( 7.2 ± 1.7 years ) with complete dietary records at 0 and 6 months . Participants were r and omized to one of three treatment conditions : ( 1 ) increased growth monitoring with feedback ; ( 2 ) decrease SFs and sugar sweetened beverages ; or ( 3 ) increase FVs and low-fat dairy . With treatment condition controlled in all analyses , FV intake significantly increased , while SF and energy intake decreased , but not significantly , from 0 to 6 months . Change in FV intake was not significantly associated with change in SF consumption . Additionally , change in FV intake was not significantly related to change in energy intake . However , reduction in SF intake was significantly related to reduction in energy intake . Changing only FVs , as compared to changing other dietary behaviors , during a pediatric obesity intervention may not assist with reducing energy intake Few studies have investigated the impact of school-based physical activity interventions on anthropometric characteristics concomitantly with aerobic and anaerobic capacities in young children . The present study aim ed to assess the effect of a 6-month physical activity program on body composition and physical fitness among primary schoolchildren . Four hundred fifty-seven
Output:
| Results : Our findings propose that school-based programs can have long-term effects in a large target group .
They have remarkable consequences on health behaviors , but as there are some common limitations , their effects on anthropometric measures are not clear .
Due to the crucial role of parents in development of children 's behaviors , family-based interventions are reported to have successful effects in some aspects ; but selection bias and high dropout rate can confound their results .
Clinic-based interventions revealed favorable effects .
They include dietary or other lifestyle changes like increasing physical activity or behavior therapy .
It seems that a comprehensive intervention including diet and exercise are more practical .
When they have different design s , results are controversial .
Conclusion : We suggest that among different types of interventional programs , a multidisciplinary approach in schools in which children 's family are involved , can be the best and most sustainable approach for management of childhood obesity |
MS212959 | ***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: OBJECTIVE To study the natural history of peripheral joint osteoarthritis ( OA ) and assess its impact over eight years in a prospect i ve study of 500 patients . METHODS 500 consecutive patients with peripheral joint OA were recruited from a hospital-based rheumatology clinic . All were invited for review 3 and 8 years after entry . Joint sites involved , pain severity , change in index joints , global change in the condition , use of medication , surgery and walking aids were all recorded at each visit , and after eight years disability was assessed by the health assessment question naire ( HAQ ) and anxiety and depression by the Hospital anxiety and depression scale ( HAD ) . RESULTS At eight-year review , 349 patients were seen : 90 % of those remaining alive . Outcome was heterogeneous . Sixty patients ( 17.2 % ) reported worsening in all three subjective parameters ( pain , index joint and global change ) compared with 22 ( 6.3 % ) who improved in all three parameters . Using this definition of worsening or improvement , strong baseline predictors of clinical outcome did not emerge . For further description , the group was split according to the index joint sites involved at entry to the study , there being 111 with knee OA alone , 87 with h and and knee OA , 72 with h and disease alone , and 29 with hip disease alone . Forty-four percent of those with lone h and disease at entry had acquired significant knee or hip OA 8 years later . The mean HAQ and HAD scores at 8 years were high , especially in those with knee disease , indicating significant disability as a result of the disease . Those with knee or knee and h and disease had the worst outcome in all parameters recorded . The data showed a general decrease in use of NSAIDs over the eight years , but an increase in utilization of analgesics , surgery ( especially for hip disease ) and walking aids . CONCLUSIONS Patients with peripheral joint OA of sufficient severity to lead to hospital referral have a heterogeneous , but generally bad outcome over 8 years , the disease result ing in high levels of physical disability , anxiety and depression , with a high level of utilization of healthcare re sources , including joint replacement , drugs and walking aids . The results were consistent with previous suggestions that peripheral joint OA in older people is characterized by the slow acquisition of new joint sites . Progression and outcome may depend on a complex set of psychosocial factors , as well as biological ones INTRODUCTION To evaluate the efficacy of a self-management support program including a 6 week self-management course , individualised phone support and goal setting in osteoarthritis patients on a waiting list for arthroplasty surgery . METHOD R and omised controlled trial of 152 public hospital out patients awaiting hip or knee replacement surgery who were not classified as requiring urgent surgery . Participants were r and omised to a self-management program or to usual care . The primary outcome was change in the Health Education Intervention Question naire ( HeiQ ) from r and omisation to 6 month follow-up . Quality of life and depressive symptoms were also measured . Changes in pain and function were assessed using the Western Ontario and McMaster Universities ( WOMAC ) Arthritis Index . RESULTS At 6 month follow-up , health-directed behaviour was significantly greater in the intervention [ mean 4.29 , 95 % confidence interval ( CI ) 3.99 - 4.58 ] than the control ( mean 3.81 , 95 % CI 3.52 - 4.09 ; P=0.017 ) . There was also a significant effect on skill and technique acquisition for the intervention ( mean 4.37 , 95 % CI 4.19 - 4.55 ) in comparison to control ( mean 4.11 , 95 % CI 3.93 - 4.29 ; P=0.036 ) . There was no significant effect of the intervention on the remaining HeiQ subscales , WOMAC pain or disability , quality of life or depressive symptoms . DISCUSSION The arthritis self-management program improved health-directed behaviours , skill acquisition and stiffness in patients on a joint replacement waiting list , although the observed effects were of modest size ( Cohen 's d between 0.36 and 0.42 ) . There was no significant effect on pain , function or quality of life in the short term . Self-management programs can assist in maintaining health behaviours ( particularly walking ) in this patient group . Further research is needed to assess their impact on quality of life and over longer periods Background This study examined the impact of a home-based self-management intervention for housebound older adults with arthritis on the adoption of health behaviors . The moderating role of socio-demographic , psychological , and physical characteristics in the process of behavior change was also investigated . Methods Participants were 113 older adult women ( n = 102 ) and men ( n = 11 ) with osteoarthritis ( OA ) or rheumatoid arthritis ( RA ) who were r and omly assigned to experimental ( n = 68 ) or wait list control ( n = 45 ) groups . Participants were interviewed using st and ardized question naires at baseline , pre-intervention , and post-intervention . Results Adjusted multilevel modeling analyses indicated that from pre to post intervention , experimental participants significantly increased their weekly frequency of exercise and relaxation activities . Socioeconomic status and depression played a moderating role in this change for exercise with larger effects occurring among more privileged , non-depressed participants . Conclusion We conclude that a self-management intervention can successfully improve involvement in exercise and relaxation among housebound older adults with arthritis There is limited underst and ing of how comorbid health conditions affect osteoarthritis (OA)-related outcomes . This study examined associations of different comorbidity measures with baseline OA-related patient-reported outcomes ( PROs ) among patients with hip and knee OA . Data were from patients ( N = 300 , 9 % female , mean age = 61.1 ; SD = 9.2 ) enrolled in a r and omized control trial at the Durham Veterans Affairs Medical Center . Separate multivariable regression models , adjusted for demographic and clinical characteristics , examined the association of each comorbidity measure with baseline PROs : pain , physical function , depressive symptoms , fatigue , and insomnia . Comorbidity measures included the Self-Administered Comorbidity Question naire ( SACQ ) , conditions reported as activity-limiting ( SACQ-AL ) , and indicators of depression , diabetes , hypertension , and back pain . Mean ( SD ) numbers of comorbid conditions and activity-limiting conditions were 3.4 ( 1.8 ) and 1.6 ( 1.4 ) , respectively . Comorbidity scores ( SACQ overall and SACQ-AL ) and individual comorbidity conditions were each associated with worse OA-related PROs adjusting for demographic and clinical factors . Worse SACQ overall and SACQ-AL scores were associated with worse mean scores for pain , depressive symptoms , fatigue , and insomnia ( p values < 0.01 ) . Additionally , increasing SACQ-AL scores were associated with worse mean scores for function ( p < 0.01 ) . Depression was associated with worse pain ( p = 0.03 ) , fatigue , and insomnia ( p values < 0.01 ) . Diabetes was associated with worse fatigue ( p = 0.01 ) , depressive symptoms ( p = 0.02 ) , and insomnia ( p = 0.03 ) . Back pain was associated with worse pain scores ( p = 0.02 ) . Results provide evidence that comorbidity burden , particularly activity-limiting conditions , is associated with worse OA-related PROs . Interventions for patients with OA need to address comorbid conditions and their impact on key outcomes UNLABELLED A major goal of osteoarthritis ( OA ) treatment is pain management to improve function and maximise quality of life . Rofecoxib is a highly selective inhibitor of cyclooxygenase-2 used in symptomatic treatment of inflammation and pain in patients with osteoarthritis of the hip or knee . AIM The primary aim of this study was to assess the effects of rofecoxib on quality of life in elderly patients with painful osteoarthritis flares of the hip or knee , who were not responsive to or had adverse reactions to previous NSAID therapy . In addition the switch pattern of NSAIDs in these patients was recorded . METHODS A 3-week prospect i ve open label multicentre study with rofecoxib 25 mg daily in 134 male and female out patients with painful osteoarthritis flares of the knee or the hip ( mean age 69 years , SD + 8) . On day 1 the patients were all switched from their previous NSAID to rofecoxib , followed by continuous daily treatment with rofecoxib 25 mg daily over 3 weeks . On day 21 the patients discontinued daily treatment with rofecoxib and had the choice between either staying on rofecoxib , switching back to their previous NSAID , trying another NSAID or stopping drug treatment . The impact on quality of life was measured by the difference in SF-12 between day 0 and day 21 . Further endpoints included changes in self-reported pain , stiffness and functional ability as measured by the WOMAC index ( Western Ontario McMaster Universities Osteoarthritis Index ) . Correlation studies were performed between the WOMAC pain subscale and quality of life as measured by the SF-12 at baseline and over the course of the study . Patients ' report of general health status and overall assessment of pain intensity , as measured by visual analogue scale ( VAS ) , was correlated with physicians ' and patients ' assessment of the efficacy of rofecoxib treatment . RESULTS Quality of life improved with rofecoxib : the physical component summary score ( SF-12 PCS ) was improved by a statistically significant + 16.2 % ( p < 0.0001 ) after 3 weeks , while the mental health component summary score ( MCS ) was improved by + 3.0 % ( n.s . ) . Disease-specific symptoms measured by the WOMAC question naire were significantly improved under rofecoxib after 3 weeks : pain decreased by 29 % ( p < 0.0001 ) and stiffness by 25 % ( p < 0.0001 ) , while functional ability increased by 24 % ( p < 0.0001 ) . The improvement in SF-12 PCS correlated negatively with the decrease in WOMAC scores ( r = -0.54 , p < 0.0001 ; r = -0.46 , p < 0.0001 and r = -0.64 , p < 0.0001 respectively ) . General health was significantly improved by + 30.5 % ( or 15.96 mm , p < 0.0001 ) between baseline and day 21 , while pain was significantly reduced by -35.2 % ( or 17.67 mm , p < 0.0001 ) on the VAS scales . At the end of the 3-week study 75 % of the patients and 84 % of the treating physicians rated the efficacy of rofecoxib from good to excellent . Two weeks after study end the planned telephone survey revealed that 54 % of the patients preferred to stay on therapy with rofecoxib , 19 % had decided to switch back to their previous NSAID ( this observation being most marked for diclofenac , where 38 % of initial diclofenac patients had decided to switch back to their initial therapy ) , 9 % had been switched to another NSAID and 7.5 % had discontinued treatment . The switch pattern is unknown in the remaining 7.5 % . CONCLUSION Rofecoxib significantly improves quality of life , as measured by the SF-12 , in OA patients who were either unresponsive to or presented with adverse reactions to previous NSAID therapy ( including celecoxib ) . In addition , rofecoxib significantly improved pain , stiffness and function , as assessed by the WOMAC question naire BACKGROUND pain is the leading symptom of osteoarthritis ( OA ) and is often chronic in nature , leading to significant morbidity and decreased quality of life . Duloxetine , a selective serotonin norepinephrine reuptake inhibitor has been demonstrated to have a central ly acting analgesic effect . OBJECTIVES the aim of the present study was to investigate the efficacy of duloxetine in reducing pain in older adults with knee OA . METHODS totally , 288 patients aged 65 years and above with primary knee OA were enrolled in this study . Patients were r and omised 1:1 . Totally , 144 received 60 mg/day of duloxetine HCL and 144 received placebo for 16 weeks . Outcome measures included pain reduction and improvement in physical functioning scores . Pain was assessed using the visual analogue pain scale ( VAS ; 0 - 100 mm ) . The Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) scores were used to assess function . RESULTS two-hundred and seventy four of the 288 patients completed the study . There was a statistically significant reduction in pain and a significant improvement in WOMAC scores at 16 weeks in the duloxetine group versus the placebo group . No serious side effects were reported . CONCLUSIONS the findings of the present study provide evidence for the efficacy and tolerability of duloxetine in reducing pain and subsequently improving function in older adults with knee OA . TRIAL REGISTRATION NCT01425827 AIM To explore general practitioners ' ( GPs ) management of osteoarthritis ( OA ) . BACKGROUND OA represents a large burden on primary care . Little is known about GPs ' current management of OA , especially influences on their prescribing quality care and the barriers
Output:
| Patients with OA diagnosed with these comorbidities experienced more pain , had frequent hospital visits , took more medication , and reported less optimal outcomes .
Anxiety and depression adversely impact the QoL of patients with OA . |
MS212960 | ***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 energy density ( ED ; kcal/g ) of an entrée influences children 's energy intake ( EI ) , but the effect of simultaneously changing both ED and portion size of an entrée on preschool children 's EI is unknown . In this within-subject crossover study , 3- to 5-year-old children ( 30 boys , 31 girls ) in a daycare facility were served a test lunch once/week for 4 weeks . The amount and type of vegetables and cheeses incorporated into the sauce of a pasta entrée were manipulated to create two versions that varied in ED by 25 % ( 1.6 or 1.2 kcal/g ) . Across the weeks , each version of the entrée was served to the children in each of two portion sizes ( 400 or 300 g ) . Lunch , consumed ad libitum , also included carrots , applesauce , and milk . Decreasing ED of the entrée by 25 % significantly ( P<0.0001 ) reduced children 's EI of the entrée by 25 % ( 63.1+/-8.3 kcal ) and EI at lunch by 17 % ( 60.7+/-8.9 kcal ) . Increasing the proportion of vegetables in the pasta entrée increased children 's vegetable intake at lunch by half of a serving of vegetables ( P<0.01 ) . Decreasing portion size of the entrée by 25 % did not significantly affect children 's total food intake or EI at lunch . Therefore , reducing the ED of a lunch entrée result ed in a reduction in children 's EI from the entrée and from the meal in both portion size conditions . Decreasing ED by incorporating more vegetables into recipes is an effective way of reducing children 's EI while increasing their vegetable intake Background Dietary energy density ( DED ) does not have a simple linear relationship to fat mass in children , which suggests that some children are more susceptible than others to the effects of DED . Children with the FTO ( rs9939609 ) variant that increases the risk of obesity may have a higher susceptibility to the effects of DED because their internal appetite control system is compromised . We tested the relationship between DED and fat mass in early adolescence and its interaction with FTO variants . Methods and Findings We carried out a prospect i ve analysis on 2,275 children enrolled in the Avon Longitudinal Study of Parents and Children ( ALSPAC ) . Diet was assessed at age 10 y using 3-day diet diaries . DED ( kJ/g ) was calculated excluding drinks . Children were genotyped for the FTO ( rs9939609 ) variant . Fat mass was estimated at age 13 y using the Lunar Prodigy Dual-energy X-ray Absorptiometry scanner . There was no evidence of interaction between DED at age 10 y and the high risk A allele of the FTO gene in relation to fat mass at age 13 y ( β = 0.005 , p = 0.51 ) , suggesting that the FTO gene has no effect on the relation between DED at 10 y and fat mass at 13 y. When DED at 10 y and the A allele of FTO were in the same model they were independently related to fat mass at 13 y. Each A allele of FTO was associated with 0.35±0.13 kg more fat mass at 13 y and each 1 kJ/g DED at 10 y was associated with 0.16±0.06 kg more fat mass at age 13 y , after controlling for misreporting of energy intake , gender , puberty , overweight status at 10 y , maternal education , TV watching , and physical activity . Conclusions This study reveals the multi-factorial origin of obesity and indicates that although FTO may put some children at greater risk of obesity , encouraging a low dietary energy density may be an effective strategy to help all children avoid excessive fat gain Background Experimental studies show that a reduction in dietary energy density ( ED ) is associated with reduced energy intake and body weight . However , few observational studies have investigated the role of ED on long-term weight and waist circumference change . Methods and Principal Findings This population -based prospect i ve cohort study included 89,432 participants from five European countries with mean age 53 years ( range : 20–78 years ) at baseline and were followed for an average of 6.5 years ( range : 1.9–12.5 years ) . Participants were free of cancer , cardiovascular diseases and diabetes at baseline . ED was calculated as the energy intake ( kcal ) from foods divided by the weight ( g ) of foods . Multiple linear regression analyses were performed to investigate the associations of ED with annual weight and waist circumference change . Mean ED was 1.7 kcal/g and differed across study centers . After adjusting for baseline anthropometrics , demographic and lifestyle factors , follow-up duration and energy from beverages , ED was not associated with weight change , but significantly associated with waist circumference change overall . For 1 kcal/g ED , the annual weight change was −42 g/year [ 95 % confidence interval ( CI ) : −112 , 28 ] and annual waist circumference change was 0.09 cm/year [ 95 % CI : 0.01 , 0.18 ] . In participants with baseline BMI < 25 kg/m2 , 1 kcal/g ED was associated with a waist circumference change of 0.17 cm/year [ 95 % CI : 0.09 , 0.25 ] . Conclusion Our results suggest that lower ED diets do not prevent weight gain but have a weak yet potentially beneficial effect on the prevention of abdominal obesity as measured by waist circumference This study examined the effect of energy density , independent of fat content and palatability , on food and energy intakes . With use of a within-subjects design , normal-weight women ( n = 18 ) were provided with meals for 2 d during each of three test sessions . During lunch , dinner , and an evening snack , subjects were given free access to a main entree varying in energy density ( low , medium , or high ) . The manipulated main entrees were similar in palatability to their counterparts across conditions . Low-energy compulsory ( consumption required ) side dishes accompanied each meal . Subjects also consumed a st and ard , compulsory breakfast . Results showed that subjects consumed a similar amount of food ( by weight ) across the three conditions of energy density . Thus , significantly more energy was consumed in the condition of high energy density ( 7532 + /- 363 kJ , or 1800 + /- 86 kcal ) than in the medium- ( 6356 + /- 281 kJ , or 1519 + /- 67 kcal ) and low- ( 5756 + /- 178 kJ , or 1376 + /- 43 kcal ) energy-density conditions ( P < 0.0001 ) . There were no differences in hunger or fullness before meals , after meals , or over the 2 d across conditions . The results from this study indicate that energy density affects energy intake independent of macronutrient content or palatability , suggesting that the overconsumption of high-fat foods may be due to their high energy density rather than to their fat content BACKGROUND The contribution of energy density ( ED ) of the total diet to increased risk of obesity from childhood into adolescence is unclear . OBJECTIVE We assessed the relation between the ED of the diet in childhood , calculated in a number of ways , and change in adiposity from childhood to adolescence . DESIGN In a prospect i ve study , 48 children ( 30 boys , 18 girls ) were initially studied at age 6 - 8 y ( baseline ) and followed up at age 13 - 17 y. Daily ED , energy intake , and food intake were assessed at baseline by 7-d weighed food records concurrent with estimates of total energy expenditure ( TEE ) by doubly labeled water . ED was calculated with the use of 5 published methods . Obesity risk was defined with the use of body fat from total body water by isotope dilution . Body fat was normalized for height and expressed as fat mass index ( FMI ) . Change in adiposity was calculated as follow-up FMI minus baseline FMI . RESULTS Misreporting of energy intake at the group level at baseline was low relative to the TEE . ED of the total diet at baseline by the 3 methods for calculating ED that excluded all or most beverages was prospect ively associated with change in FMI . However , ED of the total diet by any of the methods was not associated with change in the percentage body fat , body mass index , or waist circumference z scores . CONCLUSION The methods used to calculate ED and to assess obesity risk lead to different conclusions about the relation between the ED of the diet in childhood and gain in fat into adolescence BACKGROUND Consuming foods low in energy density ( kcal/g ) decreases energy intake over several days , but the effectiveness of this strategy for weight loss has not been tested . OBJECTIVE The effects on weight loss of 2 strategies for reducing the energy density of the diet were compared over 1 y. DESIGN Obese women ( n = 97 ) were r and omly assigned to groups counseled either to reduce their fat intake ( RF group ) or to reduce their fat intake and increase their intake of water-rich foods , particularly fruit and vegetables ( RF+FV group ) . No goals for energy or fat intake were assigned ; the subjects were instructed to eat ad libitum amounts of food while following the principles of their diet . RESULTS After 1 y , study completers ( n = 71 ) in both groups had significant decreases in body weight ( P < 0.0001 ) . Subjects in the RF+FV group , however , had a significantly different pattern of weight loss ( P = 0.002 ) than did subjects in the RF group . After 1 y , the RF+FV group lost 7.9 + /- 0.9 kg and the RF group lost 6.4 + /- 0.9 kg . Analysis of all r and omly assigned subjects also showed a different pattern of weight loss between groups ( P = 0.021 ) . Diet records indicated that both groups had similar reductions in fat intake . The RF+FV group , however , had a lower dietary energy density than did the RF group ( P = 0.019 ) as the result of consuming a greater weight of food ( P = 0.025 ) , especially fruit and vegetables ( P = 0.037 ) . The RF+FV group also reported less hunger ( P = 0.003 ) . CONCLUSION Reducing dietary energy density , particularly by combining increased fruit and vegetable intakes with decreased fat intake , is an effective strategy for managing body weight while controlling hunger BACKGROUND Dietary energy density ( ED ) reductions are associated with energy intake ( EI ) reductions . Little is known about influences on body weight ( BW ) . OBJECTIVES We examined the effects of behavioral interventions on ED values and explored how 6-mo ED changes relate to BW . DESIGN Prehypertensive and hypertensive persons were r and omly assigned to 1 of 3 groups : the established group received an 18-session intervention implementing well-established hypertension recommendations ( eg , weight loss , sodium reduction , and physical activity ) , the established+Dietary Approaches to Stop Hypertension ( DASH ) group received an 18-session intervention also implementing the DASH diet , and the advice group received 1 session on these topics . Two 24-h dietary recalls were collected ( n=658 ) . RESULTS Each group had significant declines in EI , ED , and BW . The established and established+DASH groups had the greatest EI and BW reductions . The established+DASH group had the greatest ED reduction and the greatest increase in the weight of food consumed . When groups were combined and analyzed by ED change tertiles , participants in the highest tertile ( ie , largest ED reduction ) lost more weight ( 5.9 kg ) than did those in the middle ( 4.0 kg ) or lowest ( 2.4 kg ) tertile . Participants in the highest and middle tertiles increased the weight of food they consumed ( 300 and 80 g/d , respectively ) but decreased their EI ( 500 and 250 kcal/d ) . Conversely , those in the lowest tertile decreased the weight of food consumed ( 100 g/d ) , with little change in EI . The highest and middle tertiles had favorable changes in fruit , vegetable , vitamin , and mineral intakes . CONCLUSION Both large and modest ED reductions were associated with weight loss and improved diet quality BACKGROUND Studies have shown that energy intake increases when both the fat content and energy density of the entire diet increases . When the fat content and energy density vary independently of one another , however , energy density , but not fat content , influences intake . OBJECTIVE The present study examined whether energy intake in lean and obese women is affected when either the energy density or the fat content of a portion of the diet is manipulated and palatability is held constant . DESIGN In a within-subjects design , 17 lean and 17 obese women consumed meals in the laboratory for four , 4-d test periods . In 3 of these test periods the energy density ( 4.4 and 6.7 kJ/g ) or the fat content ( 16 % and 36 % of energy ) of compulsory entrees representing 50 % of each subject 's usual energy intake was manipulated . Additional self-selected foods were consumed ad libitum at meals and as snacks . RESULTS There were no systematic differences in palatability of the manipulated foods across conditions . Obese and lean participants responded similarly to the dietary manipulations . Intake of self-selected foods at meals was reduced significantly by 16 % for both lean and obese subjects in the low- compared with the high-energy-density condition . The fat content of the compulsory foods
Output:
| Based on this evidence , the 2010 Dietary Guidelines Advisory Committee concluded that strong and consistent evidence in adults indicates that dietary patterns relatively low in energy density improve weight loss and weight maintenance .
In addition , the committee concluded that there was moderately strong evidence from method ologically rigorous longitudinal cohort studies in children and adolescents to suggest that there is a positive association between dietary energy density and increased adiposity .
This review supports a relationship between energy density and body weight in adults and in children and adolescents such that consuming diets lower in energy density may be an effective strategy for managing body weight |
MS212961 | ***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 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 Background The prevalence of obesity increased while certain measures of physical fitness deteriorated in preschool children in China over the past decade . This study tested the effectiveness of a multifaceted intervention that integrated childcare center , families , and community to promote healthy growth and physical fitness in preschool Chinese children . Methods This 12-month study was conducted using a quasi-experimental pretest/posttest design with comparison group . The participants were 357 children ( mean age = 4.5 year ) enrolled in three grade levels in two childcare centers in Beijing , China . The intervention included : 1 ) childcare center intervention ( physical activity policy changes , teacher training , physical education curriculum and food services training ) , 2 ) family intervention ( parent education , internet website for support , and family events ) , and 3 ) community intervention ( playground renovation and community health promotion events ) . The study outcome measures included body composition ( percent body fat , fat mass , and muscle mass ) , Body Mass Index ( BMI ) and BMI z-score and physical fitness scores in 20-meter agility run ( 20M-AR ) , broad jump for distance ( BJ ) , timed 10-jumps , tennis ball throwing ( TBT ) , sit and reach ( SR ) , balance beam walk ( BBW ) , 20-meter crawl ( 20M-C ) ) , 30-meter sprint ( 30M-S ) ) from a norm referenced test . Measures of process evaluation included monitoring of children ’s physical activity ( activity time and intensity ) and food preparation records , and fidelity of intervention protocol implementation . Results Children in the intervention center significantly lowered their body fat percent ( −1.2 % , p < 0.0001 ) , fat mass ( −0.55 kg , p < 0.0001 ) , and body weight ( 0.36 kg , p < 0.02 ) and increased muscle mass ( 0.48 kg , p < 0.0001 ) , compared to children in the control center . They also improved all measures of physical fitness except timed 10-jumps ( 20M-AR : −0.74 seconds , p < 0.0001 ; BJ : 8.09 cm , p < 0.0001 ; TBT : 0.52 meters , p < 0.006 ; SR : 0.88 cm , p < 0.03 ; BBW : −2.02 seconds , p < 0.0001 ; 30M-S : −0.45 seconds , p < 0.02 ; 20M-C : −3.36 seconds , p < 0.0001 ) . Process evaluation data showed that the intervention protocol was implemented with high fidelity . Conclusions The study demonstrated that a policy-driven multi-faceted intervention can improve preschool children ’s body composition and physical fitness . Program efficacy should be tested in a r and omized trial . Trial registration ChiCTR-ONRC-14004143 Excess weight gain in American Indian/Alaskan native ( AI/AN ) children is a public health concern . This study tested ( 1 ) the feasibility of delivering community-wide interventions , alone or in combination with family-based interventions , to promote breastfeeding and reduce the consumption of sugar-sweetened beverages ; and ( 2 ) whether these interventions decrease Body Mass Index ( BMI ) -Z scores in children 18–24 months of age . Three AI/AN tribes were r and omly assigned to two active interventions ; a community-wide intervention alone ( tribe A ; n = 63 families ) or community-wide intervention containing a family component ( tribes B and C ; n = 142 families ) . Tribal staff and the research team design ed community-tailored interventions and trained community health workers to deliver the family intervention through home visits . Feasibility and acceptability of the intervention and BMI -Z scores at 18–24 months were compared between tribe A and tribes B & C combined using a separate sample pretest , posttest design . Eighty-six percent of enrolled families completed the study . Breastfeeding initiation and 6-month duration increased 14 and 15 % , respectively , in all tribes compared to national rates for American Indians . Breastfeeding at 12 months was comparable to national data . Parents expressed confidence in their ability to curtail family consumption of sugar-sweetened beverages . Compared to a pretest sample of children of a similar age 2 years before the study begun , BMI -Z scores increased in all tribes . However , the increase was less in tribes B & C compared to tribe A ( −0.75 , P = 0.016 ) . Family , plus community-wide interventions to increase breastfeeding and curtail sugar-sweetened beverages attenuate BMI rise in AI/AN toddlers more than community-wide interventions alone In systematic review s , evidence -based practice and journal clubs critical appraisal tools are used to rate research papers . However , little evidence exists on whether the critical appraisal tool , subject matter knowledge or research design knowledge affect the appraisal of research papers . A match paired r and omised trial was conducted in August/September 2010 in the Faculty of Medicine , Health and Molecular Science , James Cook University , Australia . Ten participants in total were r and omly assigned to two groups using either an informal appraisal of research ( IA group ) or the Crowe Critical Appraisal Tool ( CCAT group ) , a general critical appraisal tool . Participant independently appraised five research papers , where each paper had a different research design . The scores allocated to the papers by each group were analysed . The intraclass correlation coefficient for absolute agreement was 0.76 for the informal appraisal group and 0.88 for the Crowe Critical Appraisal Tool group . The G study showed that in the informal appraisal group 24 % of variance in scores was attributable to either the rater or paper × rater interactions , whereas this was 12 % in the Crowe Critical Appraisal Tool group . Analysis of covariance showed that there were statistically significant results in the informal appraisal group for subject matter knowledge ( F(1,18 ) = 7.03 , P < 0.05 1 tailed , partial η² = 0.28 ) and rater ( F(4,18 ) = 4.57 , P < 0.05 1 tailed , partial η² = 0.50 ) . Kendall 's tau correlation coefficient also showed a significant weak positive relationship ( τ = 0.38 , P = 0.03 ) between total score and subject matter knowledge for the informal appraisal group . The Crowe Critical Appraisal Tool was more reliable than an informal appraisal of the research papers . In the informal appraisal group , there were significant effects for rater and subject matter knowledge , whereas the Crowe Critical Appraisal Tool almost eliminated the rater effect , and no subject matter knowledge effect was apparent . There was no research design knowledge effect in either group . The Crowe Critical Appraisal Tool provided much better score reliability and should help readers with different levels and types of knowledge to reach similar conclusions about a research paper THE R AND OMIZED controlled trial ( RCT ) , more than any other methodology , can have a powerful and immediate impact on patient care . Ideally , the report of such an evaluation needs to convey to the reader relevant information concerning the design , conduct , analysis , and generalizability of the trial . This information should provide the reader with the ability to make informed judgments regarding the internal and external validity of the trial . Accurate and complete reporting also benefits editors and review ers in their deliberations regarding su bmi tted manuscripts . For RCTs to ultimately benefit patients , the published report should be of the highest possible st and ard OBJECTIVE To examine the reliability of scores obtained from a proposed critical appraisal tool ( CAT ) . STUDY DESIGN AND SETTING Based on a r and om sample of 24 health-related research papers , the scores from the proposed CAT were examined using intraclass correlation coefficients ( ICCs ) , generalizability theory , and participants ' feedback . RESULTS The ICC for all research papers was 0.83 ( consistency ) and 0.74 ( absolute agreement ) for four participants . For individual research design s , the highest ICC ( consistency ) was for qualitative research ( 0.91 ) and the lowest was for descriptive , exploratory and observational research ( 0.64 ) . The G study showed a moderate research design effect ( 32 % ) for scores averaged across all papers . The research design effect was mainly in the Sampling , Results , and Discussion categories ( 44 % , 36 % , and 34 % , respectively ) . The scores for research design s showed a majority paper effect for each ( 53 - 70 % ) , with small to moderate rater or paper × rater interaction effects ( 0 - 27 % ) . CONCLUSIONS Possible reasons for the research design effect were that the participants were unfamiliar with some of the research design s and that papers were not matched to participants ' expertise . Even so , the proposed CAT showed great promise as a tool that can be used across a wide range of research design OBJECTIVE Document the impact of Let 's Go ! , a multi setting community-based childhood obesity prevention program on participants in 12 communities in Maine . METHODS The study used repeated r and om telephone surveys with 800 parents of children to measure awareness of messages and child behaviors . Surveys were conducted in schools , child care programs , and afterschool programs to track changes in policies and environments . RESULTS Findings show improvements from 2007 to 2011 : Children consuming fruits and vegetables increased from 18 % , 95 % CI [ 15 , 21 ] , to 26 % [ 23 , 30 ] ( p < .001 ) ; children limiting sugary drinks increased from 63 % [ 59 , 67 ] to 69 % [ 65 , 73 ] ( p = .011 ) ; and parent awareness of the program grew from 10 % [ 7 , 12 ] to 47 % [ 43 , 51 ] ( p < .001 ) . Participating sites implemented widespread changes to promote healthy behaviors . CONCLUSIONS A multi setting , community-based intervention with a consistent message can positively impact behaviors that lead to childhood obesity
Output:
| The most frequently reported indicators of implementation success were fidelity and coverage .
Determinants related to the social-political context and the organization were most often cited as influencing implementation , in particular , ' collaboration between community partners ' , ' the availability of ( human ) re sources ' and ' time available for implementation ' .
The association between determinants and implementation variability was never explicated . |
MS212962 | ***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 effect of television viewing ( TVV ) with and without advertisements ( ads ) on energy intake is unclear . OBJECTIVE The objectives were to test 1 ) the effect of TVV , with and without ads , on energy intake compared with a control and reading condition and 2 ) the association of distractibility and memory for ads with energy intake and body weight . DESIGN Forty-eight ( 26 female ) adults ( age : 19 - 54 y ) with a body mass index ( in kg/m(2 ) ) of 20 - 35 completed this laboratory-based study . All participants completed 4 buffet-style meals in r and om order in the following conditions : 1 ) control , 2 ) while reading , 3 ) while watching TV with food and nonfood ads ( TV-ads ) , and 4 ) while watching TV with no ads ( TV-no ads ) . Energy intake was quantified by weighing foods . Distractibility and memory for ads in the TV-ads condition were quantified with a norm-referenced test and recognition task , respectively . RESULTS Repeated- measures analysis of variance indicated that energy and macronutrient intake did not differ significantly among the 4 conditions ( P > 0.65 ) . Controlling for sex , memory for ads was associated with body weight ( r = 0.36 , P < 0.05 ) and energy intake but only when viewing TV ( r = 0.39 , P < 0.05 during the TV-no ads condition , and r = 0.29 , P = 0.06 during the TV-ads condition ) . Controlling for sex , distractibility was associated with body weight ( r = 0.36 , P < 0.05 ) but not energy intake . Distractibility , however , accounted for 13 % of the variance in men 's energy intake ( P = 0.11 ) . CONCLUSIONS TVV did not affect energy intake , but individual characteristics ( memory for ads ) were associated with body weight and energy intake in certain conditions . These characteristics should be considered in food intake and intervention studies Television viewing may contribute to obesity via promotion of sedentary behavior and exposure to food-related commercials . However , the mechanisms by which food-related commercials promote food intake are not well understood . Therefore , the purpose of the present study was to examine the impact of television advertisements on food intake according to sex and transportability , or the tendency to become engrossed in what one is viewing . Eighty-three undergraduate students , free of disordered eating symptoms , were stratified by sex and r and omly assigned to one of three conditions ( food-related advertisements , neutral advertisements , or no advertisements ) . They were then identified as high or low in transportability according to a median split . A significant interaction was found between advertisement condition and transportability such that those high in transportability ate more in the food than other advertisement conditions . A second interaction was found between sex and transportability with women high in transportability eating more food than women low in transportability irrespective of advertisement condition . No significant main effects of advertisement condition , sex , or transportability were found . Results suggest the importance of study ing the impact of individual difference variables on the relationship between food-related advertising and food intake BACKGROUND Previous studies have focused on the effects of television advertising on the energy intake of children . However , the rapidly changing food-marketing l and scape requires research to measure the effects of nontraditional forms of marketing on the health-related behaviors of children . OBJECTIVES The main aim of this study was to examine the effect of advergames that promote energy-dense snacks or fruit on children 's ad libitum snack and fruit consumption and to examine whether this consumption differed according to br and and product type ( energy-dense snacks and fruit ) . The second aim was to examine whether advergames can stimulate fruit intake . DESIGN We used a r and omized between-subject design with 270 children ( age : 8 - 10 y ) who played an advergame that promoted energy-dense snacks ( n = 69 ) , fruit ( n = 67 ) , or nonfood products ( n = 65 ) or were in the control condition ( n = 69 ) . Subsequently , we measured the free intake of energy-dense snacks and fruit . The children then completed question naire measures , and we weighed and measured them . RESULTS The main finding was that playing an advergame containing food cues increased general energy intake , regardless of the advertised br and or product type ( energy-dense snacks or fruit ) , and this activity particularly increased the intake of energy-dense snack foods . Children who played the fruit version of the advergame did not eat significantly more fruit than did those in the other groups . CONCLUSION The findings suggest that playing advergames that promote food , including either energy-dense snacks or fruit , increases energy intake in children This study examined the potential moderating role of attentional bias ( i.e. , gaze duration , number of fixations , latency of initial fixation ) in the effect of advergames promoting energy-dense snacks on children 's snack intake . A r and omized between-subject design was conducted with 92 children who played an advergame that promoted either energy-dense snacks or nonfood products . Eye movements and reaction times to food and nonfood cues were recorded to assess attentional bias during playtime using eye-tracking methods . Children could eat freely after playing the game . The results showed that playing an advergame containing food cues increased total intake . Furthermore , children with a higher gaze duration for the food cues ate more of the advertised snacks . In addition , children with a faster latency of initial fixation to the food cues ate more in total and ate more of the advertised snacks . The number of fixations on the food cues did not increase actual snack intake . Food advertisements are design ed to grab attention , and this study shows that the extent to which a child 's attention is directed to a food cue increases the effect of the advertisement Eating behaviour is often studied in the laboratory under controlled conditions . Yet people care about the impressions others form about them so may behave differently if they feel that their eating behaviour is being monitored . Here we examined whether participants are likely to change their eating behaviour if they feel that food intake is being monitored during a laboratory study . In Study 1 participants were provided with vignettes of typical eating behaviour experiments and were asked if , and how , they would behave differently if they felt their eating behaviour was being monitored during that experiment . Study 2 tested the effect of experimentally manipulating participants ' beliefs about their eating behaviour being monitored on their food consumption in the lab . In Study 1 , participants thought they would change their behaviour if they believed their eating was being monitored and , if monitored , that they would reduce their food consumption . In Study 2 participants ate significantly less food after being led to believe that their food consumption was being recorded . Together , these studies demonstrate that if participants believe that the amount of food they eat during a study is being monitored then they are likely to suppress their food intake . This may impact the conclusions that are drawn from food intake studies
Output:
| Evidence to date shows that acute exposure to food advertising increases food intake in children but not in adults .
These data support public health policy action that seeks to reduce children 's exposure to unhealthy food advertising |
MS212963 | ***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 r and omised controlled pilot study was carried out to examine the effects of adjunctive aromatherapy massage on mood , quality of life and physical symptoms in patients with cancer attending a specialist unit . Participants were r and omised to conventional day care alone or day care plus weekly aromatherapy massage using a st and ardised blend of oils for four weeks . At baseline and at weekly intervals , patients rated their mood , quality of life and the intensity and bother of two symptoms most important to them . Forty-six patients were recruited to the study . Due to a large number of withdrawals , only 11 of 23 ( 48 % ) patients in the aromatherapy group and 18 of 23 ( 78 % ) in the control group completed all four weeks . Mood , physical symptoms and quality of life improved in both groups . There was no statistically significant difference between groups in any of the outcome measures . Despite a lack of measurable benefit , all patients were satisfied with the aromatherapy and wished to continue . Whilst this pilot study has shown that a r and omised controlled trial of complementary therapy is feasible , it has also identified several areas that would require further consideration when design ing future studies , e.g. , the recruitment and retention of appropriate numbers of patients and the outcome measures used AIM The objective of this study was to determine whether reflexology has an impact on the quality of life of patients in the palliative stage of cancer . METHOD Twelve patients in the palliative stage of cancer with various tumour types were r and omised into two groups . They were r and omly assigned to receive either reflexology or placebo reflexology . All participants completed a linear analogue self- assessment scale relating to quality of life . All participants then received three sessions of either reflexology or placebo reflexology . The same person , a qualified reflexologist , provided the interventions for both groups . The participants were not aware of which intervention they were receiving . All participants then completed a second linear analogue self- assessment scale relating to quality of life . RESULTS All participants felt that their quality of life had improved , even those who had received the placebo treatment . The reflexology group , however , reported more benefit than the placebo group . There was a significant difference ( p = 0.004 ) between the reflexology group and the placebo group . CONCLUSION This study showed that reflexology does have an impact on the quality of life of patients in the palliative stage of cancer The Memorial Symptom Assessment Scale ( MSAS ) is a new patient-rated instrument that was developed to provide multidimensional information about a diverse group of common symptoms . This study evaluated the reliability and validity of the MSAS in the cancer population . R and omly selected in patients and out patients ( n = 246 ) with prostate , colon , breast or ovarian cancer were assessed using the MSAS and a battery of measures that independently evaluate phenomena related to quality of life . Symptom prevalence in the 218 evaluable patients ranged from 73.9 % for lack of energy to 10.6 % for difficulty swallowing . Based on a content analysis , three symptoms were deleted and two were added ; the revised scale evaluates 32 physical and psychological symptoms . A factor analysis of variance yielded two factors that distinguished three major symptom groups and several subgroups . The major groups comprised psychological symptoms ( PSYCH ) , high prevalence physical symptoms ( PHYS H ) , and low prevalence physical symptoms ( PHYS L ) . Internal consistency was high in the PHYS H and PSYCH groups ( Cronback alpha coefficients of 0.88 and 0.83 , respectively ) , and moderate in the PHYS L group ( alpha = 0.58 ) . Although the severity , frequency and distress dimensions were highly intercorrelated , canonical correlations and other analyses demonstrated that multidimensional assessment ( frequency and distress ) augments information about the impact of symptoms . High correlations with clinical status and quality of life measures support the validity of the MSAS and indicate the utility of several subscale scores , including PSYCH , PHYS , and a brief Global Distress Index . The MSAS is a reliable and valid instrument for the assessment of symptom prevalence , characteristics and distress . It provides a method for comprehensive symptom assessment that may be useful when information about symptoms is desirable , such as clinical trials that incorporate quality of life measures or studies of symptom epidemiology Visual analogue scales ( VAS ) and verbal rating scales ( VRS ) are widely used to assess pain . This paper presents a secondary analysis of a subsection of data collected as part of an evaluation of an intervention to improve nighttime pain . The aims were to describe the relationship between the VAS and VRS ; to compare characteristics of the noncompliant groups in terms of age , gender , type of surgery , and analgesics ; to explore the reasons for noncompletion of the VAS or VRS ; and to determine the noncompliance rates with each assessment scale . Worst and average pain scores were obtained for the second postoperative night for 417 patients . Fifty-nine patients ( 14.2 % ) did not complete the VAS . In contrast , two patients did not complete the VRS ( 0.5 % ) . The scores generated from the VAS and VRS correlated well , although the range of VAS scores corresponding to each VRS category was wide . We conclude that the VRS was more suitable for use in this clinical setting Many specialist palliative care services are under pressure to provide therapies such as aromatherapy , acupuncture or reflexology either by paid staff or volunteers . The evidence to justify the provision of such treatment , however , remains largely anecdotal as controlled clinical trials are difficult to design . Reflexology involves the application of pressure to ` reflex ’ areas of the h and s or feet with the intention of producing specific effects elsewhere in the body . The reflexologist palpates tender or painful areas that , it is suggested , indicate functional imbalance . As well as treatment of specific conditions , it is suggested that reflexology can relax the patient , which may aid selfhealing and prevention of disease . We have therefore conducted a pilot study with a r and omized controlled design to compare reflexology with simple foot massage The purpose of this study was to develop and test the Verran and Snyder-Halpern ( VSH ) Sleep Scale , an instrument to subjectively measure sleep characteristics . Four major sleep factors and their associated characteristics were proposed for the Sleep Scale . Subjects completed three r and omly ordered sleep question naires on three consecutive weekday mornings within the first two hours after arising . Scales included the VSH Sleep Scale , a sleep question naire and a sleep log . The VSH Sleep Scale had a reliability coefficient of .82 ( theta ) . Construct validity was examined by factor analysis and correlations between Sleep Scale items and corresponding items on the two other study instruments . Scale validity also was assessed by the known groups method . Beginning support for the validity of the VSH Sleep Scale is provided Research suggests that patients with cancer , particularly in the palliative care setting , are increasingly using aromatherapy and massage . There is good evidence that these therapies may be helpful for anxiety reduction for short periods , but few studies have looked at the longer term effects . This study was design ed to compare the effects of four-week courses of aromatherapy massage and massage alone on physical and psychological symptoms in patients with advanced cancer . Forty-two patients were r and omly allocated to receive weekly massages with lavender essential oil and an inert carrier oil ( aromatherapy group ) , an inert carrier oil only ( massage group ) or no intervention . Outcome measures included a Visual Analogue Scale ( VAS ) of pain intensity , the Verran and Snyder-Halpern ( VSH ) sleep scale , the Hospital Anxiety and Depression ( HAD ) scale and the Rotterdam Symptom Checklist ( RSCL ) . We were unable to demonstrate any significant long-term benefits of aromatherapy or massage in terms of improving pain control , anxiety or quality of life . However , sleep scores improved significantly in both the massage and the combined massage ( aromatherapy and massage ) groups . There were also statistically significant reductions in depression scores in the massage group . In this study of patients with advanced cancer , the addition of lavender essential oil did not appear to increase the beneficial effects of massage . Our results do suggest , however , that patients with high levels of psychological distress respond best to these therapies BACKGROUND The literature supporting the use of music therapy in palliative care is growing . However , the number of quantitative research studies investigating the use of music therapy in palliative care , and specifically anxiety , is limited . OBJECTIVE The aim of this research project was to examine the effectiveness of a single music therapy session in reducing anxiety for terminally ill patients . DESIGN A r and omized-controlled design was implemented and the following hypotheses tested . There will be a significant difference between the experimental and control groups on anxiety levels as demonstrated by the anxiety measurement of the Edmonton Symptom Assessment System ( ESAS ) , and heart rate . The experimental group received a single music therapy intervention and the control group received a volunteer visit . SETTING /SUBJECTS Twenty-five participants with end-stage terminal disease receiving inpatient hospice services were recruited . RESULTS The first hypothesis was supported . Results demonstrated a significant reduction in anxiety for the experimental group on the anxiety measurement of the ESAS ( p = 0.005 ) . A post hoc analysis found significant reductions in other measurements on the ESAS in the experimental group , specifically pain ( p = 0.019 ) , tiredness ( p = 0.024 ) and drowsiness ( p = 0.018 ) . The second hypothesis was not supported . CONCLUSIONS The study supports the use of music therapy to manage anxiety in terminally ill patients . Further studies are required to examine the effect of music therapy over a longer time period , as well as addressing other symptom issues Background About 90 % of patients with intra-thoracic malignancy experience breathlessness . Breathing training is helpful , but it is unknown whether repeated sessions are needed . The present study aims to test whether three sessions are better than one for breathlessness in this population . Methods This is a multi-centre r and omised controlled non-blinded parallel arm trial . Participants were allocated to three sessions or single ( 1:2 ratio ) using central computer-generated block r and omisation by an independent Trials Unit and stratified for centre . The setting was respiratory , oncology or palliative care clinics at eight UK centres . Inclusion criteria were people with intrathoracic cancer and refractory breathlessness , expected prognosis ≥3 months , and no prior experience of breathing training . The trial intervention was a complex breathlessness intervention ( breathing training , anxiety management , relaxation , pacing , and prioritisation ) delivered over three hour-long sessions at weekly intervals , or during a single hour-long session . The main primary outcome was worst breathlessness over the previous 24 hours ( ‘ worst ’ ) , by numerical rating scale ( 0 = none ; 10 = worst imaginable ) . Our primary analysis was area under the curve ( AUC ) ‘ worst ’ from baseline to 4 weeks . All analyses were by intention to treat . Results Between April 2011 and October 2013 , 156 consenting participants were r and omised ( 52 three ; 104 single ) . Overall , the ‘ worst ’ score reduced from 6.81 ( SD , 1.89 ) to 5.84 ( 2.39 ) . Primary analysis [ n = 124 ( 79 % ) ] , showed no between-arm difference in the AUC : three sessions 22.86 ( 7.12 ) vs single session 22.58 ( 7.10 ) ; P value = 0.83 ) ; mean difference 0.2 , 95 % CIs ( –2.31 to 2.97 ) . Complete case analysis showed a non-significant reduction in QALYs with three sessions ( mean difference –0.006 , 95 % CIs –0.018 to 0.006 ) . Sensitivity analyses found similar results . The probability of the single session being cost-effective ( threshold value of £ 20,000 per QALY ) was over 80 % . Conclusions There was no evidence that three sessions conferred additional benefits , including cost-effectiveness , over one . A single session of breathing training seems appropriate and minimises patient burden . Trial registration Registry : IS RCT N ; Trial registration number : IS RCT N49387307 ; http://www.is rct n.com/IS RCT N49387307 ; registration date : Purpose A pilot study to document changes in symptoms after acupuncture or nurse-led supportive care in patients with incurable cancer . Methods Patients receiving palliative care with estimated survival of at least 3 months were screened with the Edmonton Symptom Assessment System ( ESAS ) . Patients ( n=20 ) with significant symptoms were r and omised to receive weekly acupuncture or nurse-led supportive care for 4 weeks . ESAS scores were obtained before and after each treatment , and weekly for 6 weeks after treatment by telephone . Results 42 of 170 patients screened were eligible . 20 gave consent for recruitment . The compliance rate was 90 % for acupuncture and 80 % for nurse-led supportive care . Total symptom scores were reduced by an average of 22 % after each acupuncture visit and by 14 % after each supportive care visit . Compared with baseline , ESAS scores at the end of the follow-up period were reduced by 19 % for the acupuncture arm and 26 % for nurse-led supportive care . Conclusion Patients appear to benefit from incorporating acupuncture in the treatment of advanced incurable cancer . Acupuncture was well tolerated with no significant or unexpected side effects . Acupuncture had an immediate effect on all symptoms , whereas nurse-led supportive care had a larger impact 6 weeks after the final session . Both interventions appear helpful to this population and warrant further study Effective evaluation and treatment of cancer pain require valid and independent measurement of pain intensity , pain relief , and psychological distress . The Memorial Pain Assessment Card ( MPAC ) is a simple instrument design ed to provide rapid evaluation of these subjective experiences . On the 8.5 by 11 inch card are printed the eight pain intensity descriptors , and three visual analog scales
Output:
| CAM may provide a limited short-term benefit in patients with symptom burden . |
MS212964 | ***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 Many patients with cervical disc disease require leave from work , due to long-lasting , complex symptoms , including chronic pain and reduced levels of physical and psychological function . Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits , but not the non-specific neck pain and the frequent illness . No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery . The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease , with respect to function , disability , work capability , and cost effectiveness . Methods / Design This study was design ed as a prospect i ve , r and omised , controlled , multi-centre study . An independent , blinded investigator will compare two alternatives of rehabilitation . We will include 200 patients of working age , with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression . After providing informed consent , study participants will be r and omised to one of two alternative physiotherapy regimes ; ( A ) customary treatment ( information and advice on a specialist clinic ) ; or ( B ) customary treatment plus active physiotherapy . Physiotherapy will follow a st and ardised , structured programme of neck-specific exercises combined with a behavioural approach . All patients will be evaluated both clinical ly and subjectively ( with question naires ) before surgery and at 6 weeks , 3 months , 6 months , 12 months , and 24 months after surgery . The main outcome variable will be neck-specific disability . Cost-effectiveness will also be calculated . Discussion We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease . Trial registration Clinical Trials.gov identifier : Study Design : Retrospective review of the prospect i ve American College of Surgeons National Surgical Quality Improvement Project ( ACS NSQIP ) data base with 30-day follow-up of 2164 patients undergoing elective anterior cervical discectomy and fusion ( ACDF ) . Objective : To determine factors independently associated with increased length of stay ( LOS ) and complications after ACDF to facilitate preoperative planning and setting of realistic expectations for patients and providers . Summary of Background Data : The effect of individual preoperative factors on LOS and complications has been evaluated in small-scale studies . Large data base analysis with multivariate analysis of these variables has not been reported . Methods : The ACS NSQIP data base from 2005 to 2010 was queried for patients undergoing ACDF procedures . Preoperative and perioperative variables were collected . Multivariate regression determined significant predictors ( P<0.05 ) of extended LOS and complications . Results : Average LOS was 2.0±4.0 days ( mean±SD ) with a range of 0–103 days . By multivariate analysis , age 65 years and above , functional status , transfer from facility , preoperative anemia , and diabetes were the preoperative factors predictive of extended LOS . Major complications , minor complications , and extended surgery time were the perioperative factors associated with increased LOS . The elongating effect of these variables was determined , and ranged from 0.5 to 5.0 days . Seventy-one patients ( 3.3 % ) had a total of 92 major complications , including return to operating room ( 40 ) , venous thrombotic events ( 13 ) , respiratory ( 21 ) , cardiac ( 6 ) , mortality ( 5 ) , sepsis ( 4 ) , and organ space infection ( 3 ) . Multivariate analysis determined ASA score ≥3 , preoperative anemia , age 65 years and above , extended surgery time , and male sex to be predictive of major complications ( odds ratios ranging between 1.756 and 2.609 ) . No association was found between levels fused and LOS or complications . Conclusion : Extended LOS after ACDF is associated with factors including age , anemia , and diabetes , as well as the development of postoperative complications . One in 33 patients develops a major complication postoperatively , which are associated with an increased LOS of 5 days Objectives The aims of this study are to answer the following questions ( 1 ) How does the pain intensity of lumbar and cervical disc surgery patients change within a postoperative time frame of 5 years ? ( 2 ) Which sociodemographic , medical , work-related , and psychological factors are associated with postoperative pain in lumbar and cervical disc surgery patients ? Methods The baseline survey ( T0 ; n = 534 ) was conducted 3.6 days ( SD 2.48 ) post-surgery in the form of face-to-face interviews . The follow-up interviews were conducted 3 months ( T1 ; n = 486 patients ) , 9 months ( T2 ; n = 457 ) , 15 months ( T3 ; n = 438 ) , and 5 years ( T4 ; n = 404 ) post-surgery . Pain intensity was measured on a numeric rating-scale ( NRS 0–100 ) . Estimated changes to and influences on postoperative pain by r and om effects were accounted by regression models . Results Average pain decreased continuously over time in patients with lumbar herniated disc ( Wald Chi² = 25.97 , p<0.001 ) . In patients with cervical herniated disc a reduction of pain was observed , albeit not significant ( Chi² = 7.02 , p = 0.135 ) . Two predictors were associated with postoperative pain in lumbar and cervical disc surgery patients : the subjective prognosis of gainful employment ( p<0.001 ) and depression ( p<0.001 ) . Conclusion In the majority of disc surgery patients , a long-term reduction of pain was observed . Cervical surgery patients seemed to benefit less from surgery than the lumbar surgery patients . A negative subjective prognosis of gainful employment and stronger depressive symptoms were associated with postoperative pain . The findings may promote multimodal rehabilitation concepts including psychological and work-related support Study Design . Population ‐based , cross‐sectional mailed survey . Objective . To determine the lifetime , period , and point prevalence of neck pain and its related disability among Saskatchewan adults and investigate the presence and strength of nonresponse bias . Summary of Background Data . In Europe , the life‐time and point prevalence of neck pain is almost as high as the prevalence of low back pain . Similarly , chronic neck pain is highly prevalent and a common source of disability in the working‐age population . However , no studies specifically have documented the prevalence of neck pain and its related disability in North America . Methods . The Saskatchewan Health and Back Pain Survey was mailed to 2184 r and omly selected Saskatchewan adults aged 20‐69 years . Fifty‐five percent of the study population participated . The presence of nonresponse bias was investigated through logistic regression and wave analysis . The Chronic Pain Question naire was used to classify the severity of chronic neck pain . Results . The age‐st and ardized lifetime prevalence of neck pain is 66.7 % ( 95 % confidence interval , 63.8‐69.5 ) , and the point prevalence is 22.2 % ( 95 % confidence interval , 19.7‐24.7 ) . The age‐st and ardized 6‐month prevalence of low‐intensity and low‐disability neck pain is 39.7 % ( 95 % confidence interval , 36.7‐42.7 ) , whereas it is 10.1 % ( 95 % confidence interval , 8.2‐11.9 ) for high‐intensity and low‐disability neck pain and 4.6 % ( 95 % confidence interval , 3.3‐5.8 ) for significantly disabling neck pain . The prevalence of low‐intensity and low‐disability neck pain decreases with age . More women experience high‐disability neck pain than men . Wave analysis suggests that the point prevalence and 6‐month prevalence of high‐intensity and low‐disability neck pain are overestimated in this survey . Conclusion . This cross‐sectional study shows that neck pain is highly prevalent in Saskatchewan and that it significantly disables 4.6 % ( 95 % confidence interval , 3.3‐5.8 ) of the adult population Study Design . Prospect i ve cohort study . Objective . To examine differences between preoperative and postoperative fear of movement and investigate the relationship between fear of movement and pain , disability and physical health after spinal surgery for degenerative conditions . Summary of Background Data . Consistent evidence supports the relationship between fear of movement and higher levels of pain and disability in various chronic pain population s. Fear of movement among patients undergoing spinal surgery for chronic pain has received little attention in the literature . Methods . Participants were 141 patients treated with surgery for lumbar and cervical degenerative conditions . Assessment s were conducted before surgery and 6 weeks and 3 months after hospitalization . Fear of movement was measured with the Tampa Scale for Kinesiophobia and outcomes were measured with the Brief Pain Inventory , Oswestry or Neck Disability Index , and 12-Item Short Form Health Survey ( SF-12 ) . Results . Follow-up rates were 91 % and 87 % for 6 weeks and 3 months , respectively . Fear of movement beliefs improved after surgery , but 49 % of patients continued to have high fear of movement at 6-week follow-up and 39 % at 3-month follow-up . Patients with higher levels of fear of movement had poorer postoperative outcomes . Multilevel linear regression analyses found that postoperative fear of movement was independently associated with postoperative pain intensity , pain interference , disability , and physical health ( P < 0.001 ) , after controlling for depression , age , sex , education , race , comorbidities , type and area of surgery , prior surgeries , and baseline outcome score . Preoperative fear of movement was not predictive of poorer surgical outcomes . Conclusion . Results demonstrate that postoperative but not preoperative fear of movement beliefs explain unique and significant variance in postoperative pain , disability , and physical health . Clinicians interested in improving surgical outcomes should address postoperative fear of movement along with other traditional clinical and medical risk factors . Recommendations include postoperative screening for high fear of movement beliefs and incorporating cognitive-behavioral techniques into postoperative rehabilitation for at-risk surgical spine patients BACKGROUND CONTEXT Spinal surgery in the workers compensation population shows evidence of less favorable outcomes than in general health cases . Although spine surgery has been alleged to be a cause of poor outcomes , such outcomes may be improved by appropriate postsurgical rehabilitation . PURPOSE To compare objective demographic , physical and psychological measurements and socioeconomic outcomes of treatment in work-related disabling cervical pain for the combination of anterior cervical fusion ( ACF ) plus functional restoration , compared with rehabilitation alone . STUDY DESIGN / SETTING A prospect i ve study of patients undergoing ACF for degenerative disc disease before rehabilitation for work-related musculoskeletal disorders versus neck pain unoperated controls , with data collected in an outpatient tertiary interdisciplinary rehabilitation setting . PATIENT SAMPLE A group of 52 patients completed a functional restoration treatment program after undergoing ACF ( Group S ) at one or two levels for degenerative cervical disc disease . During the study period , 625 patients with work-related neck pain were identified from the same study population , from which a rehabilitation ( Group R ) comparison group ( n=150 ) was identified who were stratified according to the number and location of other compensable body parts . OUTCOME MEASURES Socioeconomic outcomes relevant to chronic disabling work-related cervical spinal disorders are reported based on 1-year posttreatment interviews . Pre- to posttreatment assessment of pain intensity , disability , depression and cumulative physical capability were assessed prospect ively . METHODS All patients were totally or partially disabled before completing an intensive , medically supervised , functional restoration program combining quantitatively directed exercise progression with a multimodal disability management approach . Preprogram preparation included drug detoxification , psychotropic medication management and preparatory aerobic and mobility training . The intensive treatment phase involved strength and endurance training , with counseling geared to goals of work return and fitness maintenance . The 1-year structured clinical interview had a contact rate of 93 % to 95 % , and partial information acquisition on all patients . RESULTS Although Group S had lower work return and work retention outcomes , the differences were not significant . Group S patients had significantly more health utilization from a new provider in the year after completion of functional restoration ( 46 % vs 24 % ; OR=2.7 [ 1.3 , 5.3 ] , p<.004 ) . Group S patients were also more likely to be depressed , both at pre- and postrehabilitation . There were no significant differences in recurrent injury , additional surgery , physical measures or pain/disability self-report between the groups . CONCLUSIONS Workers compensation patients with chronic disabling work-related cervical spinal disorders who undergo a cervical fusion , combined with functional restoration , have socioeconomic outcomes after their surgery statistically similar to those for unoperated controls . Surgery patients had a higher rate of additional health-care-seeking behaviors from new providers and a greater likelihood of being clinical ly depressed before and after rehabilitation . This study suggests that cervical fusion for degenerative disc disease in workers compensation patients is not contraindicated , as long as interdisciplinary rehabilitation is available for complex cases after the surgical procedure Cervical total disk arthroplasty has proven to be an effective and safe alternative for anterior cervical diskectomy and fusion ( ACDF ) for the treatment of cervical disk degenerative disease . However , whether and when cervical
Output:
| There are low- to very-low- quality evidence that some interventions ( use of cervical collars after non-plated anterior cervical diskectomy an fusion , structured physiotherapy , and interactive patients ’ education ) provide some benefit within functioning , pain , and selected psychological variables in patients undergoing cervical disk surgery .
Conclusion : There is insufficient evidence with few trials of low quality to allow any conclusion to be drawn about the effectiveness , harms , and general ineffectiveness of rehabilitation for people who have had cervical disk surgery for pain or radiculopathy |
MS212965 | ***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: Renal denervation reduces office blood pressure in patients with resistant hypertension . This study investigated the effects of renal denervation on blood pressure , heart rate , and chronotropic index at rest , during exercise , and at recovery in 60 patients ( renal denervation group=50 , control group=10 ) with resistant hypertension using a st and ardized bicycle exercise test protocol performed 6 and 12 months after renal denervation . After renal denervation , exercise blood pressure at rest was reduced from 158±3/90±2 to 141±3/84±4 mm Hg ( P<0.001 for systolic blood pressure/P=0.007 for diastolic blood pressure ) after 6 months and 139±3/83±4 mm Hg ( P<0.001/P=0.022 ) after 12 months . Exercise blood pressure tended to be lower at all stages of exercise at 6- and 12-month follow-up in patients undergoing renal denervation , although reaching statistical significance only at mild-to-moderate exercise levels ( 75–100 W ) . At recovery after 1 minute , blood pressure decreased from 201±4/95±2 to 177±4/88±2 ( P<0.001/P=0.066 ) and 188±6/86±2 mm Hg ( P=0.059/P=0.01 ) after 6 and 12 months , respectively . Heart rate was reduced after renal denervation from 71±3 bpm at rest , 128±5 bpm at maximum workload , and 96±5 bpm at recovery after 1 minute to 66±2 ( P<0.001 ) , 115±5 ( P=0.107 ) , and 89±3 bpm ( P=0.008 ) after 6 months and to 69±3 ( P=0.092 ) , 122±7 ( P=0.01 ) , and 93±4 bpm ( P=0.032 ) after 12 months . Mean exercise time increased from 6.59±0.33 to 8.4±0.32 ( P<0.001 ) and 9.0±0.41 minutes ( P=0.008 ) , and mean workload increased from 93±2 to 100±2 ( P<0.001 ) and 101±3 W ( P=0.007 ) at 6- and 12-month follow-up , respectively . No changes were observed in the control group . In conclusion , renal denervation reduced blood pressure and heart rate during exercise , improved mean workload , and increased exercise time without impairing chronotropic competence BACKGROUND The potential role of renal denervation ( RD ) in patients with AF and less severe hypertension is unknown . OBJECTIVE The purpose of this study was to assess the potential role of RD as an adjunct to pulmonary vein isolation ( PVI ) in patients with atrial fibrillation ( AF ) and moderate resistant or severe resistant hypertension . METHODS The data for this study were obtained from 2 different prospect i ve r and omized studies , analyzed by meta- analysis . Patients with paroxysmal AF or persistent AF and moderate resistant hypertension ( office blood pressure BP ≥140/90 mm Hg and < 160/100 mm Hg ; first study ; n = 48 ) or severe resistant hypertension ( ≥160/100 mm Hg ; second study ; n = 38 ) were r and omized to PVI or PVI with RD . RESULTS At 12 months , 26 of the 41 PVI with RD patients ( 63 % ) were AF-free vs 16 of the 39 patients ( 41 % ) in the PVI-only group ( P = .014 ) . In patients with severe hypertension , 11 of the 18 PVI with RD patients ( 61 % ) vs 5 of the 18 PVI-only patients ( 28 % ) were AF-free ( P = .03 ) . For moderate hypertension , the differences were less dramatic : 11 of 21 ( 52 % ) vs 15 of 23 ( 65 % ) when RD added ( P = .19 ) . The superior efficacy of adding RD was most apparent in persistent AF and severe hypertension ( hazard ratio 0.25 , confidence interval 0.09 - 0.72 , P = .01 ) . Duration of the procedure and fluoroscopy were nonsignificantly longer in the RD group . CONCLUSION RD may improve the results of PVI in patients with persistent AF and /or severe resistant hypertension & NA ; We aim ed to investigate for the first time the blood pressure (BP)–lowering effect of renal sympathetic denervation ( RDN ) versus clinical ly adjusted drug treatment in true treatment-resistant hypertension ( TRH ) after excluding patients with confounding poor drug adherence . Patients with apparent TRH ( n=65 ) were referred for RDN , and those with secondary and spurious hypertension ( n=26 ) were excluded . TRH was defined as office systolic BP ( SBP ) > 140 mm Hg , despite maximally tolerated doses of ≥3 antihypertensive drugs including a diuretic . In addition , ambulatory daytime SBP > 135 mm Hg after witnessed intake of antihypertensive drugs was required , after which 20 patients had normalized BP and were excluded . Patients with true TRH were r and omized and underwent RDN ( n=9 ) performed with Symplicity Catheter System versus clinical ly adjusted drug treatment ( n=10 ) . The study was stopped early for ethical reasons because RDN had uncertain BP-lowering effect . Office SBP and diastolic BP in the drug-adjusted group changed from 160±14/88±13 mm Hg ( ±SD ) at baseline to 132±10/77±8 mm Hg at 6 months ( P<0.0005 and P=0.02 , SBP and diastolic BP , respectively ) and in the RDN group from 156±13/91±15 to 148±7/89±8 mm Hg ( P=0.42 and P=0.48 , SBP and diastolic BP , respectively ) . SBP and diastolic BP were significantly lower in the drug-adjusted group at 6 months ( P=0.002 and P=0.004 , respectively ) , and absolute changes in SBP were larger in the drug-adjusted group ( P=0.008 ) . Ambulatory BPs changed in parallel to office BPs . Our data suggest that adjusted drug treatment has superior BP lowering effects compared with RDN in patients with true TRH . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : The first studies on renal denervation ( RDN ) suggest that this treatment is feasible , effective , and safe in the short term . Presently available data are promising , but important uncertainties exist ; therefore , SYMPATHY has been initiated . SYMPATHY is a multicenter , r and omized , controlled trial in patients r and omized to RDN in addition to usual care ( intervention group ) or to continued usual care ( control group ) . R and omization will take place in a ratio of 2 to 1 . At least 300 participants will be included to answer the primary objective . Sample size may be extended to a maximum of 570 to address key secondary objectives . The primary objective is to assess whether RDN added to usual care compared with usual care alone reduces blood pressure ( BP ) ( ambulatory daytime systolic BP ) in subjects with an average daytime systolic BP ≥135 , despite use of ≥3 BP-lowering agents , 6 months after RDN . Key secondary objectives are evaluated at 6 months and at regular intervals during continued follow-up and include the effect of RDN on the use of BP-lowering agents , in different subgroups ( across strata of estimated glomerular filtration rate and of baseline BP ) , on office BP , quality of life , and cost-effectiveness Percutaneous renal sympathetic denervation by radiofrequency energy has been reported to reduce blood pressure ( BP ) by the reduction of renal sympathetic efferent and afferent signaling . We evaluated the effects of this procedure on BP and sleep apnea severity in patients with resistant hypertension and sleep apnea . We studied 10 patients with refractory hypertension and sleep apnea ( 7 men and 3 women ; median age : 49.5 years ) who underwent renal denervation and completed 3-month and 6-month follow-up evaluations , including polysomnography and selected blood chemistries , and BP measurements . Antihypertensive regimens were not changed during the 6 months of follow-up . Three and 6 months after the denervation , decreases in office systolic and diastolic BPs were observed ( median : −34/−13 mm Hg for systolic and diastolic BPs at 6 months ; both P<0.01 ) . Significant decreases were also observed in plasma glucose concentration 2 hours after glucose administration ( median : 7.0 versus 6.4 mmol/L ; P=0.05 ) and in hemoglobin A1C level ( median : 6.1 % versus 5.6 % ; P<0.05 ) at 6 months , as well as a decrease in apnea-hypopnea index at 6 months after renal denervation ( median : 16.3 versus 4.5 events per hour ; P=0.059 ) . In conclusion , catheter-based renal sympathetic denervation lowered BP in patients with refractory hypertension and obstructive sleep apnea , which was accompanied by improvement of sleep apnea severity . Interestingly , there are also accompanying improvements in glucose tolerance . Renal sympathetic denervation may conceivably be a potentially useful option for patients with comorbid refractory hypertension , glucose intolerance , and obstructive sleep apnea , although further studies are needed to confirm these proof-of-concept data BACKGROUND Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension . METHODS We design ed a prospect i ve , single-blind , r and omized , sham-controlled trial . Patients with severe resistant hypertension were r and omly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure . Before r and omization , patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs , including a diuretic . The primary efficacy end point was the change in office systolic blood pressure at 6 months ; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure . The primary safety end point was a composite of death , end-stage renal disease , embolic events result ing in end-organ damage , renovascular complications , or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70 % at 6 months . RESULTS A total of 535 patients underwent r and omization . The mean ( ±SD ) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group ( P<0.001 for both comparisons of the change from baseline ) , for a difference of -2.39 mm Hg ( 95 % confidence interval [ CI ] , -6.89 to 2.12 ; P=0.26 for superiority with a margin of 5 mm Hg ) . The change in 24-hour ambulatory systolic blood pressure was -6.75±15.11 mm Hg in the denervation group and -4.79±17.25 mm Hg in the sham-procedure group , for a difference of -1.96 mm Hg ( 95 % CI , -4.97 to 1.06 ; P=0.98 for superiority with a margin of 2 mm Hg ) . There were no significant differences in safety between the two groups . CONCLUSIONS This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control . ( Funded by Medtronic ; SYMPLICITY HTN-3 Clinical Trials.gov number , NCT01418261 . ) Objective : Renal denervation ( RDN ) has been demonstrated to reduce muscle sympathetic nerve activity ( MSNA ) and blood pressure ( BP ) in patients with resistant hypertension . Whether alterations of arterial stiffness may contribute to BP-lowering effects of RDN is unknown . Methods : We measured office BP and arterial stiffness using fingertip tonometry-derived augmentation index ( EndoPAT2000 ) at baseline and at 3-month follow-up in 50 consecutive patients with resistant hypertension . Forty patients received RDN and 10 patients served as controls . MSNA was obtained in 20 RDN and 10 non-RDN patients . Results : Baseline BP averaged 170/92 ± 19/15 mmHg ( RDN ) and 171/93 ± 14/8 mmHg ( non-RDN ) despite the use of 4.9 ± 1.9 and 4.4 ± 2.0 antihypertensive drugs , respectively . RDN significantly reduced SBP ( 1
Output:
| AUTHORS ' CONCLUSIONS In patients with resistant hypertension , there is low quality evidence that renal denervation does not change major cardiovascular events , and renal function .
There was moderate quality evidence that it does not change blood pressure and and low quality evidence that it caused an increaseof bradycardia episodes . |
MS212966 | ***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 Endothelial dysfunction is frequently present in individuals with insulin resistance or type 2 diabetes and can be induced by high-fat or high-carbohydrate meals . Because exenatide reduces postpr and ial glucose and lipid excursions , we hypothesized that it may also improve postpr and ial endothelial function . RESEARCH DESIGN AND METHODS In a double-blinded r and omized crossover design , postpr and ial endothelial function was examined in 28 individuals with impaired glucose tolerance or recent-onset type 2 diabetes after a single injection of exenatide or placebo given just before a high-fat meal . Endothelial function was determined with peripheral arterial tonometry pre- and postpr and ially . RESULTS Postpr and ial endothelial function was higher after exenatide compared with placebo ( P = 0.0002 ) . In the placebo phase , postpr and ial change in endothelial function was inversely associated with mean postpr and ial concentrations of triglycerides ( r = −0.62 , P = 0.0004 ) . Changes in postpr and ial triglyceride concentrations explained 64 % of exenatide 's effect on postpr and ial endothelial function . CONCLUSIONS Exenatide ameliorates postpr and ial endothelial dysfunction after a high-fat meal Introduction Pregnancy is associated with decreased insulin sensitivity , which is usually overcome by a compensatory increase in insulin secretion . Some pregnant women are not able to increase their insulin secretion sufficiently , and consequently develop gestational diabetes mellitus ( GDM ) . The disease normally disappears after delivery . Nevertheless , women with previous GDM have a high risk of developing type 2 diabetes ( T2D ) later in life . We aim to investigate the early development of T2D in women with previous GDM and to evaluate whether treatment with the glucagon-like peptide-1 receptor ( GLP-1R ) agonist , liraglutide , may modify their risk of developing T2D . Methods and analyses 100 women with previous GDM will be r and omised to either liraglutide or placebo treatment for 1 year ( blinded ) with an open-label extension for another 4 years . Additionally , 15 women without previous GDM will constitute a baseline control group . Women will be tested with an oral glucose tolerance test ( primary endpoint : area under the curve for plasma glucose ) and an isoglycaemic intravenous glucose infusion at baseline , after 1 year and after 5 years . Additional evaluations include a glucagon test , dual-energy X-ray absorptiometry , imaging of the liver ( ultrasound elastography and fibroscanning ) , an ad libitum meal for food intake evaluation and question naires related to appetite , quality of life and alcohol consumption habits . Ethics and dissemination The protocol has been approved by the Danish Medicines Agency , the Scientific-Ethical Committee of the Capital Region of Denmark , and the Danish Data Protection Agency and will be carried out under the surveillance and guidance of the GCP unit at Copenhagen University Hospital Bispebjerg in compliance with the ICH-GCP guidelines and in accordance with the Helsinki Declaration . Positive , negative and inconclusive results will be published at scientific conferences and as one or more scientific manuscripts in peer- review ed journals . Registration s The trial is registered at https://eudract.ema.europa.eu ( 2012 - 001371 - 37 ) and http://www . clinical trials.gov ( NCT01795248 ) Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged PURPOSE We aim ed to assess the impact of spin ( ie , reporting to convince readers that the beneficial effect of the experimental treatment is greater than shown by the results ) on the interpretation of results of abstract s of r and omized controlled trials ( RCTs ) in the field of cancer . METHODS We performed a two-arm , parallel-group RCT . We selected a sample of published RCTs with statistically nonsignificant primary outcome and with spin in the abstract conclusion . Two versions of these abstract s were used-the original with spin and a rewritten version without spin . Participants were clinician corresponding authors of articles reporting RCTs , investigators of trials , and review ers of French national grants . The primary outcome was clinicians ' interpretation of the beneficial effect of the experimental treatment ( 0 to 10 scale ) . Participants were blinded to study hypothesis . RESULTS Three hundred clinicians were r and omly assigned using a Web-based system ; 150 clinicians assessed an abstract with spin and 150 assessed an abstract without spin . For abstract s with spin , the experimental treatment was rated as being more beneficial ( mean difference , 0.71 ; 95 % CI , 0.07 to 1.35 ; P = .030 ) , the trial was rated as being less rigorous ( mean difference , -0.59 ; 95 % CI , -1.13 to 0.05 ; P = .034 ) , and clinicians were more interested in reading the full-text article ( mean difference , 0.77 ; 95 % CI , 0.08 to 1.47 ; P = .029 ) . There was no statistically significant difference in the clinicians ' rating of the importance of the study or the need to run another trial . CONCLUSION Spin in abstract s can have an impact on clinicians ' interpretation of the trial results BACKGROUND & AIMS Uncontrolled studies show sitagliptin , an oral DPP-4 inhibitor , may improve alanine aminotransferase and liver histology in non-alcoholic fatty liver disease ( NAFLD ) patients . We aim ed to compare sitagliptin vs. the efficacy of a placebo in reducing liver fat measured by MRI-derived proton density-fat fraction ( MRI-PDFF ) . METHODS This r and omized , double-blind , allocation-concealed , placebo-controlled trial included 50 NAFLD patients with prediabetes or early diabetes r and omized to sitagliptin orally 100mg/day or placebo for 24weeks . Primary outcome was liver fat change measured by MRI-PDFF in colocalized regions of interest within each of nine liver segments . Additional advanced assessment s included MR spectroscopy ( MRS ) for internal validation of MRI-PDFF 's accuracy , and magnetic resonance elastography ( MRE ) and FIBROSpect ® II to assess liver fibrosis . RESULTS Sitagliptin was not significantly better than placebo in reducing liver fat measured by MRI-PDFF ( mean difference between sitagliptin and placebo arms : -1.3 % , p=0.4 ) . Compared to baseline , there were no significant differences in end-of-treatment MRI-PDFF for sitagliptin ( 18.1 % to 16.9 % , p=0.27 ) or placebo ( 16.6 % to 14.0 % , p=0.07 ) . The groups had no significant differences for changes in alanine aminotransferase , aspartate aminotransferase , low-density lipoprotein , homeostatic model assessment insulin resistance , and MRE-derived liver stiffness . In both groups at baseline and post-treatment , MRI-PDFF and MRS showed robust correlation coefficients ranging from r(2)=0.96 to r(2)=0.99 ( p<0.0001 ) , demonstrating the strong internal validity of the findings . FIBROSpect ® II showed no changes in the sitagliptin group but was significantly increased in the placebo group ( p=0.03 ) . CONCLUSIONS Sitagliptin was safe but not better than placebo in reducing liver fat in prediabetic or diabetic patients with NAFLD . LAY SUMMARY In a r and omized , double-blind , placebo-controlled study , the anti-diabetic drug sitagliptin was no more effective than placebo for improving liver fat and liver fibrosis in patients with non-alcoholic fatty liver disease . This study demonstrates that non-invasive magnetic resonance imaging techniques , including magnetic resonance imaging-proton density-fat fraction and magnetic resonance elastography , can be used to assess treatment response in non-alcoholic fatty liver disease clinical trials BACKGROUND The cardiovascular safety and efficacy of many current antihyperglycemic agents , including saxagliptin , a dipeptidyl peptidase 4 ( DPP-4 ) inhibitor , are unclear . METHODS We r and omly assigned 16,492 patients with type 2 diabetes who had a history of , or were at risk for , cardiovascular events to receive saxagliptin or placebo and followed them for a median of 2.1 years . Physicians were permitted to adjust other medications , including antihyperglycemic agents . The primary end point was a composite of cardiovascular death , myocardial infa rct ion , or ischemic stroke . RESULTS A primary end-point event occurred in 613 patients in the saxagliptin group and in 609 patients in the placebo group ( 7.3 % and 7.2 % , respectively , according to 2-year Kaplan-Meier estimates ; hazard ratio with saxagliptin , 1.00 ; 95 % confidence interval [ CI ] , 0.89 to 1.12 ; P=0.99 for superiority ; P<0.001 for noninferiority ) ; the results were similar in the " on-treatment " analysis ( hazard ratio , 1.03 ; 95 % CI , 0.91 to 1.17 ) . The major secondary end point of a composite of cardiovascular death , myocardial infa rct ion , stroke , hospitalization for unstable angina , coronary revascularization , or heart failure occurred in 1059 patients in the saxagliptin group and in 1034 patients in the placebo group ( 12.8 % and 12.4 % , respectively , according to 2-year Kaplan-Meier estimates ; hazard ratio , 1.02 ; 95 % CI , 0.94 to 1.11 ; P=0.66 ) . More patients in the saxagliptin group than in the placebo group were hospitalized for heart failure ( 3.5 % vs. 2.8 % ; hazard ratio , 1.27 ; 95 % CI , 1.07 to 1.51 ; P=0.007 ) . Rates of adjudicated cases of acute and chronic pancreatitis were similar in the two groups ( acute pancreatitis , 0.3 % in the saxagliptin group and 0.2 % in the placebo group ; chronic pancreatitis , < 0.1 % and 0.1 % in the two groups , respectively ) . CONCLUSIONS DPP-4 inhibition with saxagliptin did not increase or decrease the rate of ischemic events , though the rate of hospitalization for heart failure was increased . Although saxagliptin improves glycemic control , other approaches are necessary to reduce cardiovascular risk in patients with diabetes . ( Funded by AstraZeneca and Bristol-Myers Squibb ; SAVOR-TIMI 53 Clinical Trials.gov number , NCT01107886 . )
Output:
| AUTHORS ' CONCLUSIONS There is no firm evidence that DPP-4 inhibitors or GLP-1 analogues compared mainly with placebo substantially influence the risk of T2DM and especially its associated complications in people at increased risk for the development of T2DM . |
MS212967 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: To assess age and gender differences in muscle strength , isometric , concentric ( Con ) , and eccentric ( Ecc ) peak torque was measured in the knee extensors at a slow ( 0.52 rad/s ) and fast ( 3.14 rad/s ) velocity in 654 subjects ( 346 men and 308 women , aged 20 - 93 yr ) from the Baltimore Longitudinal Study of Aging . Regression analysis revealed significant ( P < 0.001 ) age-related reductions in Con and Ecc peak torque for men and women at both velocities , but no differences were observed between the gender groups or velocities . Age explained losses in Con better than Ecc peak torque , accounting for 30 % ( Con ) vs. 19 % ( Ecc ) of the variance in men and 28 % ( Con ) vs. 11 % ( Ecc ) in women . To assess age and gender differences in the ability to store and utilize elastic energy , the stretch-shortening cycle was determined in a subset of subjects ( n = 47 ) . The older women ( mean age = 70 yr ) showed a significantly greater enhancement in the stretch-shortening cycle , compared with men of similar age ( P < 0.01 ) and compared with younger men and women ( each P < 0.05 ) . Both men and women showed significant declines in muscle quality for Con peak torque ( P < 0.01 ) , but no gender differences were observed . Only the men showed a significant decline in muscle quality ( P < 0.001 ) for Ecc peak torque . Thus both men and women experience age-related losses in isometric , Con , and Ecc knee extensor peak torque ; however , age accounted for less of the variance in Ecc peak torque in women , and women tend to better preserve muscle quality with age for Ecc peak torque . In addition , older women have an enhanced capacity to store and utilize elastic energy compared with similarly aged men as well as with younger women and men The purpose s of this study were to analyze the impact of 24 weeks of vibratory and multicomponent training ( MT ) and to determine what type of training creates greater adaptations on body composition and isokinetic strength of the knee and ankle joints in postmenopausal women . Thirty-eight women ( 60.0 ± 6.3 years ) were r and omly assigned to whole body vibration group ( WBVG ) , multicomponent training group ( MTG ) , or a control group . A significant decrease in total fat mass was observed in experimental groups . There were no changes in total lean mass and total bone mineral density in both groups . WBVG and MTG showed significant increases in isokinetic strength for knee extensors at 60 ° /s and at 270 ° /s . Regarding the ankle joint , there were significant increments in strength for plantar flexion at 60 ° /s in WBVG and at 120 ° /s in the two trainings groups . MTG showed a significant increase in strength for dorsiflexion at 60 ° /s . With respect to eversion and inversion , WBVG and MTG improved strength at 60 ° /s . Also , the WBVG showed increased strength in the ankle evertors at 120 ° /s and both groups showed increased strength in the ankle invertors at 120 ° /s . Twenty-four weeks of whole body vibration or MTs result in positive modifications in total fat mass . These trainings are effective in improving knee extension and stabilizer muscles of the ankle joint strength Forty-eight community living women 66–87 years old volunteered to participate in a 12-month prospect i ve , r and omized , controlled , trial . The aim was to determine if a combined weight-bearing training program twice a week would be beneficial to bone mineral density and neuromuscular function . The participants were pairwise age-matched and r and omly assigned to either an exercise group ( n=24 ) or a control group ( n=24 ) . Twenty-one subjects in the intervention group and 19 in the control group completed the study . The exercise program lasted for 50 min and consisted of a combination of strengthening , aerobic , balance and coordination exercises . The mean percentage of scheduled sessions attended for the exercise group was 67 % . At the completion of the study , the intervention group showed significant increments in bone mineral density of the Ward ’s triangle ( 8.4 % , P<0.01 ) as well as improvement in maximum walking speed ( 11.4 % , P<0.001 ) and isometric grip strength ( 9.9 % , P<0.05 ) , as compared to the control group . The conclusion was that a combined weight-bearing training program might reduce fracture risk factors by improving bone density as well as muscle strength and walking ability . This program could be suitable for older community living women in general , and might , therefore , have important implication s for fracture prevention Summary We determined the effect of antioxidants and resistance training on bone mineral density of postmenopausal women . After 6 months , we observed a significant decrease in the lumbar spine BMD of the placebo group while other groups remained stable . Antioxidants may offer protection against bone loss such as resistance training . Introduction The purpose of this pilot study was to determine the effects of antioxidant supplements combined to resistance training on bone mineral density ( BMD ) in healthy elderly women . Methods Thirty-four postmenopausal women ( 66.1 ± 3.3 years ) were r and omized in four groups ( placebo , n = 7 ; antioxidants , n = 8 ; exercise and placebo , n = 11 ; and exercise and antioxidants , n = 8) . The 6-month intervention consisted in antioxidant supplements ( 600 mg vitamin E and 1,000 mg vitamin C daily ) or resistance exercise ( 3 × /week ) . Femoral neck and lumbar spine BMD ( DXA ) and dietary intakes ( 3-day food record ) were measured before and after the intervention . A repeated measure ANOVA and non-parametric Mann – Whitney U tests were used . Results We observed a significant decrease in the placebo group for lumbar spine BMD ( pre , 1.01 ± 0.17 g/cm2 ; post , 1.00 ± 0.16 g/cm2 ; P < 0.05 respectively ) while it remained stable in all other groups . No changes were observed for femoral neck BMD . Conclusions Antioxidant vitamins may offer some protection against bone loss in the same extent as resistance exercise although combining both does not seem to produce additional effects . Our results suggest to further investigate the impact of antioxidant supplements on the prevention of osteoporosis Summary This study showed that combination of strength , balance , agility and jumping training prevented functional decline and bone fragility in home-dwelling elderly women . The finding supports the idea that it is possible to maintain good physical functioning by multi-component exercise program and thus postpone the age-related functional problems . Introduction This 1-year r and omized , controlled exercise intervention trial assessed the effects of two different training programs and their combination on physical functioning and bone in home-dwelling elderly women . Methods One hundred and forty-nine healthy women aged 70–78 years were r and omly assigned into : group 1—resistance training ( RES ) , group 2—balance-jumping training ( BAL ) , group 3—combination of resistance and balance-jumping training ( COMB ) , and group 4—controls ( CON ) . Self-rated physical functioning , leg extensor force , dynamic balance , and bone mass and structure were measured . Results Self-rated physical functioning improved in the COMB group , but was reduced in the CON group ; the mean inter-group difference was 10 % ( 95 % CI : 0–22 % ) . Mean increase in the leg extensor force was higher in the RES ( 14 % ; 4–25 % ) and COMB ( 13 % ; 3–25 % ) compared with the CON groups . Dynamic balance improved in the BAL ( 6 % ; 1–11 % ) and in the COMB ( 8 % ; 3–12 % ) groups . There were no inter-group differences in BMC at the proximal femur . In those COMB women who trained at least twice a week , the tibial shaft structure weakened 2 % ( 0–4 % ) less than those in the CON group . Conclusions Strength , balance , agility , and jumping training ( especially in combination ) prevented functional decline in home-dwelling elderly women . In addition , positive effects seen in the structure of the loaded tibia indicated that exercise may also play a role in preventing bone fragility 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 This study examined the correlations between isokinetic muscle strength of knee and elbow flexors and extensors with vertebral and femoral bone mineral density in a population of 106 women between the ages of 44 and 87 years . The absolute value of muscle strength correlated significantly with bone mineral density ; muscle strength of the upper limb appeared to be more closely correlated with bone mass , while muscle strength in the lower limb was more specific for femoral mineral bone density . The most important finding that these results demonstrated was a concomitant decline in muscle strength of the upper limb and bone mineral density between the 5th and 6th decades . In contrast , they also showed a decline in muscle strength of the lower limbs after the 6th decade , occurring before the decline in bone mineral density observed between the 7th and 8th decades . From these results it would appear that other studies are required to examine the relationship between the essentially hormonal role in postmenopausal decline in muscle strength and the decline in physical activity during the senile period . These elements are important because they must be taken into account in physical exercise programmes design ed to prevent osteoporosis UNLABELLED We prospect ively examined vBMD and structural bone parameters assessed by QCT among participants of the InCHIANTI study over a 6-yr follow-up . Periosteal apposition occurred both in men and women . Endocortical resorption causes bone loss in older women despite periosteal apposition . INTRODUCTION To address the hypothesis that age-related changes in BMD and bone geometry may be different in men and women , we prospect ively examined volumetric BMD ( vBMD ) and structural bone parameters assessed by QCT among participants of the InCHIANTI study over a 6-yr follow-up . MATERIAL S AND METHODS Three hundred forty-five men and 464 women 21 - 102 yr of age from the InCHIANTI study , a population -based study in Tuscany , Italy , were included . Tibial QCT bone parameters were measured at enrollment ( 1998 - 2000 ) and at 3- ( 2001 - 2003 ) and 6-yr ( 2004 - 2006 ) follow-ups . RESULTS Periosteal apposition occurred both in men and women . The annual rate of bone periosteal apposition was higher in younger than in older men , whereas in women , the rate of apposition was homogenous across age groups . The age-related medullary expansion , expression of endocortical resorption , was significantly higher in women compared with men . In women , but not in men , accelerated endocortical resorption not sufficiently balanced by periosteal apposition caused accelerated loss in cortical bone mass . The cross-sectional moment of inertia decreased progressively over the life span in both sexes . CONCLUSIONS Endocortical resorption causes bone loss in older women despite periosteal apposition . Obtaining a balance between endocortical resorption and periosteal apposition should be the target for interventions aim ed to decrease bone loss and prevent osteoporosis in older women BACKGROUND Physical exercise affects many risk factors and diseases and therefore can play a vital role in general disease prevention and treatment of elderly individuals and may reduce costs . We sought to determine whether a single exercise program affects fracture risk ( bone mineral density [ BMD ] and falls ) , coronary heart disease ( CHD ) risk factors , and health care costs in community-dwelling elderly women . METHODS We conducted a r and omized , single-blinded , controlled trial from May 1 , 2005 , through July 31 , 2008 , recruiting women 65 years or older who were living independently in the area of Erlangen-Nuremberg , Germany . In all , 246 women were r and omly assigned to an 18-month exercise program ( exercise group ) or a wellness program ( control group ) . The exercise group ( n = 123 ) performed a multi purpose exercise program with special emphasis on exercise intensity ; the controls ( n = 123 ) focused on well-being with a low-intensity , low-frequency program . The main outcome measures were BMD , the number of falls , the Framingham-based 10-year CHD risk , and direct health care costs . RESULTS For the 227 women who completed the 18-month study , significant exercise effects were observed for BMD of the lumbar spine ( mean [ 95 % confidence interval ( CI ) ] percentage of change in BMD [ baseline to follow-up ] for the exercise group : 1.77 % [ 1.26 % to 2.28 % ] vs controls : 0.33 % [ -0.24 % to 0.91 % ] ; P < .001 ) , femoral neck ( exercise group : 1.01 % [ 0.37 % to 1.65 % ] vs controls : -1.05 % [ -1.70 % to -0.40 % ] ; P < .001 ) , and fall rate per person during 18 months ( exercise group : 1.00 [ 0.76 to 1.24 ] vs controls
Output:
| Studies examining the effects of combined training methods in postmenopausal and older women showed contrasting results , possibly due to the wide range of the participants ’ age , the evaluation of different regions , and the varying characteristics of the training methods between studies .
Overall , it appears that exercise modes that combine resistance , weight-bearing training , and impact-aerobic activities can increase or prevent muscle and skeletal mass loss during the ageing process in women . |
MS212968 | ***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 double-blind clinical study was to compare the tooth whitening efficacy ( stain removal ) of a new commercially available tooth whitening dentifrice ( Colgate Total Plus Whitening Toothpaste ) containing 0.2 % triclosan and 3.0 % PVM/MA copolymer in a 0.243 % sodium fluoride/high cleaning silica base , with that of two commercially available dentifrices , Crest Multi-Care Advanced Cleaning Toothpaste and Colgate Winterfresh Gel Fluoride Toothpaste . Following a baseline examination to assess extrinsic tooth stain , qualifying adult male and female subjects were r and omized into three treatment groups which were balanced for gender , age and level of extrinsic tooth stain . Subjects were asked to brush their teeth twice ( morning and evening ) for one minute with their assigned dentifrice using a soft-bristled toothbrush . Examinations for extrinsic tooth stain were repeated after six weeks ' use of the study dentifrices . One-hundred and twenty-three ( 123 ) subjects complied with the protocol and completed the study . At the six-week examination , subjects assigned to the Colgate Total Plus Whitening Toothpaste treatment group exhibited statistically significant reductions in extrinsic tooth stain area and extrinsic tooth stain intensity relative to those subjects assigned to the Crest Multi-Care Advanced Cleaning Toothpaste and the Colgate Winterfresh Gel Fluoride Toothpaste The objective of this double-blind clinical study was to investigate the tooth whitening efficacy of a new commercially available calculus-inhibiting dentifrice ( Colgate Tartar Control Plus Whitening Fluoride dentifrice ) containing tetra-sodium pyrophosphate , sodium tripolyphosphate , and PVM/MA copolymer in a 0.243 % sodium fluoride/silica base ( test dentifrice ) , compared to a commercially available , non-tooth whitening dentifrice containing 0.243 % sodium fluoride in a silica base ( control dentifrice ) . Following a baseline examination for , extrinsic tooth stain , qualifying adult male and female subjects from the Manchester , United Kingdom area were r and omized into two treatment groups which were balanced for gender , age and level of extrinsic tooth stain . Subjects were instructed to brush their teeth twice daily ( morning and evening ) for one minute with their assigned dentifrice using a soft-bristled toothbrush . Examinations for extrinsic tooth stain were repeated after six weeks ' use of the study dentifrices . Seventy-nine(79 ) subjects complied with the protocol and completed the entire study . At the six-week examination , subjects assigned to the test dentifrice treatment group exhibited statistically significant reductions of over 40 % with respect to both extrinsic tooth stain area and extrinsic tooth stain intensity relative to those subjects assigned to the control dentifrice treatment group The objective of this double-blind clinical study was to compare the efficacy for extrinsic tooth stain removal of four commercially available dentifrices : Colgate Tartar Control with Baking Soda & Peroxide Fluoride Toothpaste ; Aquafresh Advanced Whitening Toothpaste with Fluoride ; Rembr and t Tartar Control Low Abrasion Fluoride Whitening Toothpaste ; and Crest Regular Fluoride Toothpaste . Following a baseline examination for extrinsic tooth stain on the anterior six m and ibular and maxillary teeth , qualifying adult male and female subjects from the Philadelphia , Pennsylvania area were r and omized into four treatment groups which were balanced for age , gender , tobacco habits , and level of extrinsic tooth stain . Subjects were instructed to brush their teeth twice daily ( morning and evening ) for one minute with their assigned dentifrice using a soft-bristled toothbrush . Examinations for extrinsic tooth stain were repeated after six weeks ' use of the study dentifrices . One hundred eighty ( 180 ) subjects complied with the protocol , and completed the entire study . At the six-week examination , subjects assigned to the Colgate Tartar Control with Baking Soda & Peroxide Fluoride Toothpaste treatment group exhibited statistically lower levels of extrinsic tooth stain area and extrinsic tooth stain intensity than did those subjects assigned to the Crest Regular Fluoride treatment group . Subjects assigned to the Aquafresh Advanced Whitening treatment group exhibited significantly lower levels of extrinsic tooth stain area than did those assigned the Crest Regular Fluoride group . No other significant differences among the four study dentifrices were noted . Thus , the results of this double-blind clinical study support the conclusion that Colgate Tartar Control with Baking Soda & Peroxide Fluoride Toothpaste provides significantly greater control of extrinsic tooth stain than does Crest Regular Fluoride , a sodium fluoride/silica dentifrice OBJECTIVE The objective of this clinical investigation was to evaluate the effectiveness in removing existing extrinsic tooth stains of a sodium bicarbonate ( baking soda ) , dual-phase dentifrice containing calcium and phosphate ( Test Dentifrice ) , when compared to a commercial hydrated silica dentifrice ( Control Dentifrice ) , during a six-week period of normal , unsupervised use . METHODOLOGY This investigation was a double-blind comparison of two equivalent , parallel groups of subjects assigned to use different dentifrices for six weeks . A total of 108 adult male and female subjects qualified for the trial based on the presence of existing extrinsic tooth stains and other inclusion /exclusion criteria . The two groups were balanced for gender , tobacco use , and extrinsic tooth stain scores , and r and omly assigned the Test or Control dentifrices . All subjects were instructed to brush their teeth twice daily using only the dentifrice and toothbrush provided , and to refrain from using any other oral hygiene products for the duration of the study . Although product usage was unsupervised after the baseline visit , subjects maintained a treatment diary , and product consumption was monitored to estimate compliance . Oral soft and hard tissue and extrinsic stain assessment s ( Modified Lobene Stain Index ) for each subject were conducted at baseline and after two , four , and six weeks of product use . RESULTS A total of 107 subjects complied with the protocol and completed the six-week study . Compared to baseline , at the two- , four- , and six-week examinations the Test Dentifrice group had statistically significant reductions in extrinsic tooth stain . In contrast , the Control Dentifrice group did not attain significant reductions from baseline at any of the exams . At both the four-week and six-week examinations , the Test Dentifrice group had significantly lower levels of extrinsic tooth stain than the Control Dentifrice group . CONCLUSION A sodium bicarbonate , dual-phase dentifrice containing calcium and phosphate demonstrated statisically significant efficacy in removing naturally acquired , extrinsic tooth stain , and was significantly more effective for stain removal than a commercially available , hydrated silica dentifrice The effect of twice-daily brushing with one of three different dentifrices ( Arm & Hammer Dental Care , Arm & Hammer Dental Care Extra Whitening , Crest ) on stain removal and tooth whitening was examined in 115 volunteers over a period of 12 weeks . The facial surfaces of 12 anterior teeth were assessed for stain using a published , modified version of a st and ard stain index . Whiteness was measured on teeth 8 and 9 using a single Vita Lumin-Vaccum Shade Guide for consistency . At baseline , the mean facial stain scores were significantly higher ( p < 0.05 - 0.01 ) for both Arm & Hammer dentifrices than for Crest . In addition , the tooth shades , as indicated by the stain guide , specifically the b * values representing yellowness , were quantified using a Minolta spectrophotometer . Arm & Hammer Dental Care Extra Whitening formula was found to be significantly better than Crest at removing naturally occurring extrinsic stain . The difference between Arm & Hammer Dental Care Extra Whitening and Crest became significant ( p < 0.01 ) after two weeks of use , and remained intact during the balance of the study , achieving p values of 0.0002 for at least one of the three assessed parameters ( total stain , proximal , and facial ) at weeks 4 and 12 . The study also found that Arm & Hammer Dental Care produced a significant increase in tooth whiteness by week 12 , whereas Crest showed no such increase at any time during the study . These results suggest that the two Arm & Hammer Baking Soda products are more effective in reducing stain and increasing whiteness than the st and ard silica-based dentifrice . Their effectiveness is not related to abrasivity since they are less abrasive to tooth enamel than the silica-based product tested OBJECTIVES To evaluate a modified tooth stain index and determine the effect of dietary factors on stain formation . METHODS At baseline , 182 adult volunteers were given a full oral prophylaxis followed by stain assessment using a modification of the Lobene index . This involved assigning separate scores to the mesial ( M ) and distal ( D ) sites of each tooth , in addition to the st and ard gingival area ( G ) and tooth body ( B ) . For each site , stain intensity and areas were scored . The sum of ( intensity X area ) scores was calculated for all sites ( GBMD-value ) and for the gingival and body sites only ( GB-value ) . The subjects used a st and ard abrasive dentifrice and a soft toothbrush for 6 weeks . RESULTS Stain was reassessed and the average increase in GBMD-value was 20.9 ( sd=9.9 ) ( buccal aspect ) and 29.9 ( sd=18.0 ) ( lingual aspect ) . The corresponding GB-values were 4.4 ( sd=4.8 ) and 12.5 ( sd=10.2 ) . The coefficients of variation of the GBMD index values were consistently lower than those of the GB values . Smoking and tea-drinking were found to be the only significant ( p<0.001 ) factors investigated for stain formation . CONCLUSIONS It is concluded that the modified index may well be advantageous to its conventional counterpart because sites with most visible stain are assessed separately and because it may also offer higher discriminatory power due to a lower coefficient of variation OBJECTIVE The primary purpose of this r and omized , controlled , six-week clinical trial was to determine the effectiveness and safety of a new whitening dentifrice in removing extrinsic tooth stain and whitening teeth . An additional two-week exploratory study was conducted to determine whether the whitening or stain-prevention activity of the dentifrice would persist following cessation of use . METHODS In the first study ( Phase I ) , one-hundred and forty-six qualifying subjects were r and omly assigned to either a sodium bicarbonate whitening dentifrice group ( Arm & Hammer Advance White Extreme Whitening Baking Soda and Peroxide Toothpaste ) or a silica-based negative control dentifrice group , and brushed twice daily with their assigned dentifrice for six weeks . Tooth shade on the labial surfaces of the eight incisors was assessed using a Vita Classic shade guide , and extrinsic tooth stain was scored using a Modified Lobene Stain Index ( MLSI ) at baseline , week 4 , and week 6 . In Phase II ( after the week 6 examination ) , volunteers from the Arm & Hammer whitening dentifrice group were r and omly assigned to continue using the whitening dentifrice or to use the negative control dentifrice twice daily for two weeks . The six-week shade and stain index scores served as the baseline for this exploratory phase and were rescored after two weeks . RESULTS The whitening dentifrice group had statistically significant ( p < 0.0001 ) mean shade score reductions of 1.82 and 2.57 from baseline to weeks 4 and 6 , respectively . For the same periods , the negative control dentifrice group was virtually unchanged from baseline . For tooth stain , the MLSI total mean scores for the whitening dentifrice group showed statistically significant ( p < 0.0001 ) decreases from baseline of 1.42 ( 41.6 % ) and 2.11 ( 61.6 % ) at weeks 4 and 6 , respectively . In contrast , the negative control dentifrice group had a MLSI reduction of 0.07 at week 4 and a 0.06 increase at week 6 . Between-group analyses using baseline-adjusted ANCOVA showed the whitening dentifrice to be statistically significantly more effective ( p < 0.0001 ) than the negative control for shade and tooth stain reductions for all index comparisons . Compared to the six-week ( baseline ) scores , subjects who continued to use the whitening dentifrice for the additional two weeks experienced statistically significant ( p < 0.0001 ) further mean reductions of 0.88 in shade score and 0.46 in MLSI score , while subjects who switched to the negative control dentifrice experienced smaller , statistically significant ( p < 0.05 ) reductions of 0.34 in shade score and 0.13 in total MLSI score . CONCLUSION The Arm & Hammer whitening dentifrice tested in this study is effective for removing extrinsic tooth stain and whitening teeth . While the results also suggest that this dentifrice may have stain-prevention activity that persists following cessation of product use , such activity would need to be confirmed with further studies The objective of this double-blind clinical study was to investigate the tooth whitening efficacy of a new dentifrice ( Colgate Tartar Control Plus Whitening Fluoride Toothpaste ) for the removal of extrinsic tooth stain , through a comparison with two commercially available dentifrices , Aquafresh Whitening Toothpaste with Fluoride , and Crest Regular Fluoride Toothpaste . Following a baseline examination for extrinsic tooth stain area and intensity , qualifying adult male and female subjects from the Mississauga , Ontario , Canada area were r and omized into three treatment groups which were balanced for age , gender , and level of extrinsic to
Output:
| In this review , nearly all dentifrices that are specifically formulated for tooth whitening were shown to have a beneficial effect in reducing ETD , irrespective of whether or not a chemical discoloration agent was added |
MS212969 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: This study sought to compare the analgesic efficacy and safety of patient controlled intra-nasal ( PCIN ) fentanyl with oral morphine for procedural wound care in burns patients . A r and omised double-blind placebo controlled , two period , two-treatment crossover trial was conducted within the Burns Unit of a major teaching hospital in Perth , Western Australia . Patients requiring identical wound care procedures on two consecutive mornings ( and not prescribed intravenous analgesia ) were r and omised to receive either PCIN fentanyl with oral placebo or oral morphine with intranasal placebo on 1 day , followed by the alternate active drug on the following day . Twenty-six patients ( 22 males ) , aged between 18 and 69 years ( 35.5 + /- 12.4 years ) , with total body surface burns ( TBSA ) range 1 - 25 % ( 6.9 + /- 4.5 ) , indicated their level of pain on a 10 point ( 0 - 10 ) numeric scale at various time periods before , during and after the procedure . A mean total dose of 1.48 + /- 0.57 microg/kg of PCIN fentanyl and 0.35 + /- 0.12 mg/kg of oral morphine was administered . No statistically significant difference was found between the pain scores recorded for patients during the procedure with PCIN fentanyl compared to that with oral morphine ( mean difference = -0.75 , 95 % CI = -1.97 to 0.47 , P = 0.22 ) . Two patients experienced hypotension during the procedure -- both had received active oral morphine . No patients experienced respiratory depression or a significant drop in oxygen saturation . There were four episodes ( in three patients ) where ' rescue analgesia ' for severe pain was required -- two episodes involving oral morphine and two involving PCIN fentanyl . It was concluded that PCIN fentanyl is similar in efficacy and safety to oral morphine for relief of procedural wound care pain in burns patients A prospect i ve study was design ed to compare two psychological support interventions in controlling peri-dressing change pain and anxiety in severely burned patients . Thirty patients with a total burned surface area of 10 - 25 % , requiring a hospital stay of at least 14 days , were r and omised to receive either hypnosis or stress reducing strategies ( SRS ) adjunctively to routine intramuscular pre-dressing change analgesia and anxiolytic drugs . Visual analogue scale ( VAS ) scores for anxiety , pain , pain control and satisfaction were recorded at 2-day intervals throughout the 14-day study period , before , during and after dressing changes . The psychological assistance was given on days 8 and 10 after hospital admission . The comparison of the two treatment groups indicated that VAS anxiety scores were significantly decreased before and during dressing changes when the hypnotic technique was used instead of SRS . No difference was observed for pain , pain control and satisfaction , although VAS scores were always better in the hypnosis group . The study also showed that , overall , psychological support interventions reduced pain and increased patient satisfaction . These results confirm the potential benefits of psychological assistance during dressing changes in burned patients This prospect i ve study evaluated the efficacy and safety of IV ibuprofen for the reduction of fever and treatment of pain in patients with thermal burn injury . A total of 61 patients with second- and /or third-degree thermal burns covering > 10 % TBSA were r and omly assigned in a 2:1 ratio to receive either 800 mg IV ibuprofen or placebo every 6 hours for 120 hours ( 5 days ) . Antipyretic medications were restricted during the first 24 hours of the study , but analgesics were allowed throughout . The primary efficacy endpoint was area under the curve for temperature ( AUC-T ° ) within the first 24 hours of treatment . After 24 hours of dosing , there was a significant reduction in temperature in patients who received IV ibuprofen compared with those who received placebo ( P = .008 ) . The temperature remained reduced over the entire 120-hour dosing period in the patients who received IV ibuprofen , although the difference beyond 24 hours did not reach statistical significance . Because of enrollment of patients unable to perform self- assessment s of pain , an inadequate number of patients were enrolled to detect differences in pain scores . There was no significant difference in the incidence of serious adverse events . Fever was reduced significantly by IV ibuprofen in burn patients over the initial 24-hour dosing period and remained reduced throughout the dosing period . Exposure to the maximum daily recommended dose of 3200 mg ( 800 mg every 6 hours ) for a total of 120 hours ( 5 days ) was well tolerated This study tested the efficacy of 2 brief cognitive interventions in supplementing regular medical treatment for pain during burn dressing change . Forty-two burn in patients were r and omly assigned to 3 groups : sensory focusing , music distraction , and usual care . Patients reported pain , pain relief , satisfaction with pain control and pain coping strategies . The sensory focusing group reported greater pain relief compared to the music distraction group and a reduction in remembered pain compared to the usual care group , although group differences were not observed on serial pain ratings . In addition , after controlling for burn size and relevant covariates , regression analyses indicated that catastrophizing predicted pain , memory for pain , and satisfaction with pain control . Refinement of the sensory focusing intervention is warranted to reduce catastrophic thinking and improve pain relief Background : The adverse consequences of burn injuries include pain and psychological distress , which show bidirectional associations . However , much of the existing research has relied on global measures of distress that do not separate distinct symptoms of anxiety and depression . Purpose : The purpose is to assess the prospect i ve effects of anxiety and depression on pain and functional outcomes following burn injury . Methods : This article describes a 2-year cohort study in patients hospitalized for serious burn injuries ( assessment s at discharge and 6-month , 1-year , and 2-year follow-up ) . Linear mixed effects analyses were conducted to model anxiety and depression ’s unique longitudinal effects ; at each time point , depressive and anxiety symptoms were studied as predictors of subsequent changes in pain , fatigue , and physical function . Results : When studied in separate prediction models , both depression and anxiety were strong prospect i ve predictors of greater pain , more fatigue , and physical dysfunction at the subsequent time point ( ps<.01 ) . However , when both were included in a single model to study their unique effects , depressive symptoms ( but not anxiety ) emerged as a signfiicant predictor of subsequent increases in pain and reductions in physical functioning , whereas anxiety ( but not depression ) predicted subsequent elevations in fatigue . Conclusions : These findings suggest potentially distinct effects of depression and anxiety and imply that assessment and early treatment of both depressive and anxiety symptoms may help improve a broad range of long-term pain-related outcomes following burn inury & NA ; This r and omised , double‐blind , placebo‐controlled trial assessed the efficacy and tolerability of pregabalin to alleviate the neuropathic component of moderate to severe burn pain . Patients aged 18 to 65 years admitted to a burns unit with a 5 % or greater total body surface area burn injury were screened to participate in the trial . Using the Neuropathic Pain Scale ( NPS ) , patients scoring 4 or higher on ‘ hot ’ pain or ‘ sharp ’ pain were invited to participate . Consenting patients were r and omly assigned to receive pregabalin or placebo for 28 days with individual dose titration commencing at 75 mg twice daily to a maximum pregabalin dose of 300 mg twice daily . The primary outcome measure was the patients ’ daily response to the sharp and hot pain of the NPS . Secondary outcome measures included the remaining elements of the NPS , daily opioid requirement , length of hospital stay , pain at 6 months , and side effects of nausea , vomiting , drowsiness and giddiness . For patients administered pregabalin , the primary outcome measures hot ( P = .01 ) and sharp ( P = .04 ) pain were significantly reduced compared with those in patients administered placebo . Secondary outcome measures of itch , unpleasantness , surface pain , and procedural pain were significantly lower ( P < .05 ) in the pregabalin group . Adverse effects were uncommon , with no difference between the treatment groups . There was no significant difference between the pregabalin and placebo treatment groups with respect to opioid consumption , duration of hospital stay , or pain at 6 months . Pregabalin was efficacious and well tolerated in patients after severe burn injury and whose pain was characterised by features of acute neuropathic pain . In this study , pregabalin was well tolerated and significantly reduced several elements of the neuropathic pain scale including hot pain , unpleasantness of the pain , surface pain , and itch , and also significantly reduced procedural pain Pain and anxiety are well-documented problems during the rehabilitation of patients with burns . This study examined the effect of music on anxiety and pain during range of motion . Eleven subjects with partial-thickness or deeper burns were r and omly assigned to a control group ( without music intervention ) or experimental group ( with music intervention ) . Vital signs , pain , and anxiety were recorded before and after treatments . There was no difference in pretest and posttest anxiety across the groups ; however , there was a difference in anxiety between the groups . Conversely , there was a difference in pretest and posttest pain across the groups but no difference in pain between the groups . Results showed no significant reduction in anxiety and pain during therapy with music relaxation . Limitations included nonhomogenous groups , small sample size , potentially unrepresentative sample , variation in exercise protocol , and small musical selection . Further research is recommended Burn patients must often endure intense pain during their regular dressing changes . The aim of the present study was to investigate the therapeutic effect of rapid induction analgesia ( RIA ) on resting and procedural pain , anticipatory anxiety , relaxation levels and medication consumption in 30 hospitalized burn patients . Patients rated levels of pain and relaxation for four burn care sessions . RIA was conducted twice on 15 patients , whereas dressing changes proceeded as usual in 15 control patients . When asked to recall pain during the dressing changes , patients remembered an experience which was worse in its entirety than the average of spot ratings taken during the burn care procedure . However , self-reported ratings of the sensory and affective components of pain decreased significantly during and after RIA , particularly in patients who became readily absorbed , and relaxation increased during burn care . Anticipatory anxiety decreased before dressing changes in the RIA group , and analgesic intake decreased between treatment sessions . The promising outcome of this study confirms RIA as a viable adjunct to narcotic treatment for pain control during burn care The purpose of this single-blinded r and omized clinical trial was to determine whether therapeutic touch ( TT ) versus sham TT could produce greater pain relief as an adjunct to narcotic analgesia , a greater reduction in anxiety , and alterations in plasma T-lymphocyte concentrations among burn patients . Therapeutic touch is an intervention in which human energies are therapeutically manipulated , a practice conceptually supported by Rogers ' ( 1970 ) theory of unitary human beings . Data were collected at a university burn centre in the south-eastern United States . The subjects were 99 men and women between the ages of 15 and 68 hospitalized for severe burns , and they received either TT or sham TT once a day for 5 days . Baseline data were collected on day 1 , data were collected before and after treatment on day 3 , and post-intervention data were collected on day 6 . Instruments included the McGill Pain Question naire , Visual Analogue Scales for Pain , Anxiety and Satisfaction with Therapy , and an Effectiveness of Therapy Form . Blood was drawn on days 1 and 6 for lymphocyte subset analysis . Medication usage for pain in mean morphine equivalents , and mean doses per day of sleep , anxiety and antidepressant medications were recorded . Subjects who received TT reported significantly greater reduction in pain on the McGill Pain Question naire Pain Rating Index and Number of Words Chosen and greater reduction in anxiety on the Visual Analogue Scale for Anxiety than did those who received sham TT . Lymphocyte subset analyses on blood from 11 subjects showed a decreasing total CD8 + lymphocyte concentration for the TT group . There was no statistically significant difference between groups on medication usage Abstract Benzodiazepines are commonly used to supplement opioid analgesics in treating procedural pain during the treatment of major burn injuries . To date , no study has investigated whether benzodiazepines actually have an analgesic or anxiolytic effect in such circumstances . Seventy‐nine patients admitted to a major regional burn center were r and omly assigned to groups that received 1 mg of lorazepam or a placebo in addition to their st and ard opioid analgesics . A strong analgesic effect of lorazepam was not observed when treatment groups were compared independent of their baseline pain ratings . However when patients who had high baseline pain were compared , lorazepam result ed in a significant reduction in pain ratings ( adjusted post‐treatment VAS mean score=54.28 ; adjusted control VAS mean score=69.06 ) . Trait anxiety did not predict those patients who had an analgesic effect with lorazepam , but state anxiety did prove to be a covariate with visual analogue score decreases in pain reports The authors examined ratings on a scale of pain-related anxiety in 173 burn patients in three groups : patients with small burns , patients with moderate burns and patients with extensive burns . The data suggest a greater degree of anxiety during procedures and before procedures in the burn patients with extensive burns than in burn patients with small and moderate burns . This study introduces a novel measure of pain-related anxiety in clinical burn patients , the abbreviated Burn Specific Pain Anxiety Scale ( BSPAS ) , which showed a high degree of reliability . The alpha coefficients were high for the BSPAS subscales Pain management during burn dressing changes is a critical part of treatment in acute burn injuries . Although several treatment options have been suggested , it is still a challenge
Output:
| Unidimensional pain assessment tools were most frequently used pain assessment tools , with multidimensional tools used less often , despite the multifaceted and complex nature of burn pain .
The review highlights the lack of consistency of pain assessment tool use in r and omized clinical trials with respect to managing burn pain . |
MS212970 | ***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: Office blood pressure ( OBP ) , ambulatory blood pressure ( ABP ) , and vascular reactivity were measured in 12 normotensive ' social ' drinkers ( mean alcohol consumption of 9.7 + /- 3.1 g/day ) after 4 days of alcohol consumption ( 1 g/kg/day ) and compared with the effects of an isocaloric substitute ( sucrose , 1.75 g/kg/day ) or no intervention . Alcohol consumption did not affect OBP or 24-mean ABP but appeared to decrease nocturnal systolic and diastolic blood pressure soon after consumption . Although vascular reactivity did not differ between the groups , the blood pressure rise in response to isometric exercise tended to be lower following alcohol . Thus , short-term alcohol ingestion by normotensive ' social ' drinkers does not increase office or ambulatory blood pressure A direct pressor effect of alcohol is proposed as the basis for the association between regular alcohol consumption and an increase in blood pressure found in population studies . To examine this further , a r and omized controlled crossover trial of the effects of varying alcohol intake on blood pressure in 46 healthy male drinkers was conducted . From an average of 336 ml of ethanol per week , alcohol consumption was reduced by 80 % for 6 weeks by drinking a low alcohol content beer alone . This reduction was associated with a significant reduction in systolic and diastolic blood pressure ( p less than 0.001 and p less than 0.05 respectively ) . The mean difference in supine systolic blood pressure during the last 2 weeks of normal or low alcohol intake was 3.8 mm Hg , which correlated significantly with change in alcohol consumption ( r = 0.53 , p less than 0.001 ) . Reduction of alcohol intake also caused a significant decrease in weight ( p less than 0.001 ) . After adjustment for weight change , an independent effect of alcohol on systolic but not diastolic blood pressure was still evident , with a 3.1 mm Hg fall predicted for a decrease in consumption from 350 ml of ethanol equivalent per week to 70 ml per week ( p less than 0.01 ) . Systolic blood pressure rose again when normal drinking habits were resumed . These results provide clear evidence for a direct and reversible pressor effect of regular moderate alcohol consumption in normotensive men and suggest that alcohol may play a major role in the genesis of early stages of blood pressure elevation The effect of alcohol on blood-pressure was studied in 16 men with hypertension who regularly drank up to 80 g of alcohol daily . Antihypertensive treatment was stopped 2 weeks before the men were admitted to hospital for a 7-day study . Blood pressure remained high in 8 patients who continued their regular alcohol consumption up to the fourth day after admission . In the next 4 days no alcohol was taken and diastolic and systolic blood pressures fell significantly . 8 other patients had no alcohol for the first 3 days after admission , but they resumed alcohol consumption from day 4 to 7 . In these patients , blood pressure fell slightly after admission . Re introduction of alcohol produced statistically significant increases in both systolic and diastolic pressures . This study demonstrated a pressor effect of alcohol in patients with hypertension and confirms the link between alcohol and blood-pressure reported in population studies . The mechanism of alcohol-induced hypertension is uncertain and is more likely to be due to an effect of alcohol rather than to the pressor response produced by alcohol withdrawal Fifty-four untreated , mildly hypertensive men whose daily alcohol consumption was > or = 28 ml ethanol and who drank at least 4 times per week took part in a r and omized , controlled crossover trial . The purpose of the trial was to test the effects of alcohol reduction on blood pressure . After a 2-week familiarization period , the participants were assigned to either a reduced alcohol drinking group or a usual drinking group for 3 weeks ( experimental period 1 ) . The situation was then reversed for the next 3 weeks ( experimental period 2 ) . The participants were requested to limit their daily alcohol consumption to zero or reduce it as much as possible for the reduced alcohol consumption period . The self-reported alcohol consumption was 56.1 + /- 3.6 ( SEM ) ml/day during the usual alcohol drinking period and 26.1 + /- 3.0 ml/day during the period of reduced alcohol consumption . Systolic and diastolic blood pressures in the intervention group were found by analysis of variance to be significantly lower ( 2.6 - 4.8 and 2.2 - 3.0 mm Hg , respectively ) than those in the control group during experimental period 2 for systolic blood pressure and experimental period 1 for diastolic blood pressure . Significant ( 3.6 mm Hg ) and nonsignificant ( 1.9 mm Hg ) decreases in systolic and diastolic blood pressure , respectively , were observed . The method of Hills and Armitage was used , reducing ethanol in daily alcohol consumption by 28 ml . The lowering effect of reduced alcohol consumption on blood pressure was independent of changes in salt consumption , which were estimated by 24-hour urine collection and body weight . ( ABSTRACT TRUNCATED AT 250 WORDS 44 men with treated essential hypertension who were moderate to heavy drinkers took part in a r and omised , controlled , crossover trial of the effects of alcohol intake on blood pressure . Usual antihypertensive treatment was maintained throughout 6 weeks of normal drinking and 6 weeks of drinking only a low-alcohol beer . Self-reported changes in alcohol consumption ( mean [ SEM ] from 452 [ 30 ] ml ethanol/week during normal drinking to 64 [ 8 ] ml/week while drinking the low-alcohol beer ) were confirmed by biochemical measurements . Mean systolic and diastolic blood pressures were significantly lower during the last 2 weeks of the low-alcohol period than during the normal-alcohol period , the mean difference in the supine readings being 5.0 ( 1.4 ) and 3.0 ( 0.9 ) mm Hg , respectively . Regression analysis suggested that reduction in alcohol intake contributed to the fall in both systolic and diastolic blood pressures independently of changes in weight . Thus , curtailing alcohol intake may lead to improved blood-pressure control and may reduce the need for antihypertensive drugs The vasodilation that follows acute alcohol intake is hard to conciliate with the high prevalence of hypertension detected in those persons who consume regular amounts of alcohol . In this experiment we examined early and late hemodynamic effects of acute administration of water and of 15 g , 30 g , and 60 g of alcohol in 40 normal men , aged 19 to 30 years , using 24-h ambulatory blood pressure monitoring ( ABPM ) . Mean systolic and diastolic blood pressures were each approximately 4 mm Hg lower during the period immediately after ingestion of 60 g ( v 0 g ) of ethanol , and were 7 and 4 mm Hg higher , respectively , at night . The day minus night differences displayed a dose-response curve both for systolic ( P < .001 ) and diastolic blood pressure ( P = .045 ) . Three subjects in the 60-g group had more than 50 % of nightly blood pressure loads in the hypertensive range against none in the remaining groups ( P < .01 ) . In conclusion , our findings suggest that acute alcohol intake elicits a biphasic hemodynamic response , causing , first , vasodilatation and , later , a pressor effect . The higher prevalence of hypertension in alcohol abusers seen in epidemiological surveys may be , in part , a result of measurements done in the period of transiently increased blood pressure during ethanol washout PURPOSE Restriction of alcohol intake is widely recommended in the treatment of hypertension . However , we have observed that alcohol may have biphasic effects on blood pressure in Japanese men with hypertension . METHODS Hypertensive men ( n = 34 ) who habitually drank alcohol were r and omly assigned to keep their drinking habits constant for 4 weeks , or to abstain ( or reduce alcohol intake to a maximum of 15 mL/day ) for 4 weeks in a crossover design . Amount of alcohol intake was recorded by each patient throughout the study . Office and 24-hour ambulatory blood pressure were measured at the end of both periods . RESULTS After alcohol restriction , mean ( + /-SD ) ethanol intake decreased from 66+/-26 mL/day to 11+/-10 mL/day . Office systolic blood pressure decreased slightly from 142+/-12 mm Hg to 139+/-11 mm Hg , and diastolic blood pressure decreased significantly from 95+/-7 mm Hg to 93+/-7 mm Hg in the low-alcohol period . Daytime systolic blood pressure fell by 3+/-9 mm Hg ( P < 0.05 ) , but nighttime systolic blood pressure rose by 4+/-9 mm Hg ( P < 0.05 ) with restriction of alcohol intake . Thus , average 24-hour blood pressure did not change , although 24-hour heart rate and day-night difference in blood pressure decreased significantly in the low-alcohol period . CONCLUSION In Asian men with hypertension , restriction of alcohol intake reduces daytime blood pressure but not night-time or 24-hour blood pressure Ten normal volunteers consumed 80 g of ethanol per day or abstained from ethanol for 4 consecutive days prior to measurements of blood pressure , heart rate , vascular responsiveness to noradrenaline ( NA ) and angiotensin II ( AII ) infusions and sympathetic responsiveness to isometric h and grip exercise in an open , r and om order , crossed study . Supine systolic and diastolic pressures and heart rates , and erect systolic pressures rose significantly following ethanol . Vascular responsiveness to NA infusions was reduced in all subjects following ethanol , while responses to AII infusions did not show a consistent pattern of change . Plasma renin activity , plasma NA and adrenaline concentrations , and concentrations of the NA metabolite 3,4 dihydroxyphenylethylene glycol ( DHPG ) did not significantly differ following ethanol and control treatments . The rise in plasma NA following 2 min isometric h and grip at 50 % of maximal effort was greater following ethanol ( 0.24 + /- 0.21 nM ) than control ( 0.12 + /- 0.10 nM ) but the difference did not reach statistical significance . The pressor effect of regular ethanol consumption and the reduced vascular reactivity to NA may both be the result of an increase in sympathetic activity that was not large enough to measurably alter resting plasma NA concentrations 1 . Forty‐four males with treated essential hypertension and a moderate‐to‐heavy alcohol intake participated in a r and omized controlled crossover trial of the effects of varying alcohol intake on blood pressure control . Usual antihypertensive therapy was maintained unchanged throughout Objectives The International Nifedipine GITS Study Intervention as a Goal in Hypertension Treatment ( INSIGHT ) showed , by means of office blood pressure measurements , that long-term treatment with nifedipine GITS is as effective as diuretics in preventing cardiovascular and cerebrovascular complications . However , since office blood pressure measurements reflect to a limited extent blood pressure outside the office , a side-arm INSIGHT study in which patients underwent both office measurement and 24 h ambulatory blood pressure monitoring was also performed . Design and methods The study had a r and omized , double-blind , parallel group design . After 4 weeks of placebo , mild-to-moderate essential hypertensive patients were r and omized to nifedipine GITS 30 mg or amiloride 2.5 + hydrochlorothiazide 5 mg for 3.1 years . Dose titration was performed by dose doubling and addition of atenolol 25–50 mg or enalapril 5–10 mg , or other drugs when needed . Analysis was carried out by intention-to-treat and included computation of 24 h , day and night ambulatory blood pressure and heart rate values . Additional analyses included computation of the trough-to-peak ratio and the smoothness index ( the ratio between the average of the 24-hourly blood pressure reductions after treatment and its st and ard deviation ) . Results A total of 151 patients were recruited and 149 were valid for analysis : 78 patients had 24 h ambulatory recordings both at baseline and during treatment and 134 during treatment . Office , 24 h and day and night blood pressures were all significantly and similarly reduced by both treatments . Office and ambulatory heart rate was left unchanged by diuretics , while it was slightly reduced by nifedipine . Median trough-to-peak ratios were always > 0.5 and superimposable between the two treatment groups . Similarly , smoothness indices of systolic and diastolic blood pressures were comparably high for nifedipine and diuretics , thus demonstrating a similar well-balanced antihypertensive response to both drugs . No significant differences were observed between the two treatment groups in the number of cardiovascular events ( 17 in the nifedipine-based and 26 in the diuretics-based treatment group ) . Conclusions In the INSIGHT study , the long-term antihypertensive effect on 24 h blood pressure and the cardiovascular protection of nifedipine was similar to that of diuretics Background and aims The Hypertension Optimal Treatment ( HOT ) study showed that when antihypertensive treatment reduces diastolic blood pressure well below 90 mmHg , there can be a further reduction of cardiovascular events , particularly myocardial infa rct ion , with no evidence of a J-shaped curve at lower pressures . Office measurement , however , gives no information about blood pressure outside
Output:
| An early effect of alcohol leading to a reduction BP ( in the hours after exposure ) and a later effect ( next day ) of raising BP led to smaller differences in the net effect of alcohol on BP when ambulatory BP monitoring measurements were compared with casual office- or clinic-based measurements .
These findings indicate that the timing of BP measurements after alcohol intake has a substantial effect on the magnitude and perhaps even the direction of BP change |
MS212971 | ***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 vali date the predictive impact of a hypoxia gene expression classifier in identifying patients with head and neck squamous cell carcinoma ( HNSCC ) having benefit from hypoxic modification of radiotherapy . PATIENTS AND METHODS Gene expressions were quantified from formalin-fixed , paraffin-embedded tumour biopsies of 323 HNSCC patients r and omized for placebo or nimorazole in conjunction with radiotherapy in the DAHANCA 5 study . Tumours were classified as either " more " or " less " hypoxic with a classifier constituting of 15 hypoxia responsive genes . The predictive impact was evaluated by analysing the response to nimorazole vs. placebo in terms of loco-regional tumour control ( LRC ) and disease-specific survival ( DSS ) in the two classified groups . RESULTS Hundred and fourteen patients ( 35 % ) were classified as having " more " hypoxic tumours . These patients had a significant benefit of hypoxic modification with nimorazole compared with placebo in terms of LRC ( 5-year actuarial values 49 % vs. 18 % ; p=0.001 ) and DSS ( 48 % vs. 30 % ; p=0.04 ) . " Less " hypoxic tumours had no significant effect of hypoxic modification ( LRC : 50 % vs. 44 % ; p=0.39 , DSS : 57 % vs. 51 % ; p=0.49 ) and generally an outcome , which was similar to " more " hypoxic tumours treated with nimorazole . In contrast to HPV-negative tumours , HPV-positive tumours had a substantially better outcome in response to radiotherapy , which was irrespective of hypoxic modification . CONCLUSIONS A predictive 15-gene hypoxia classifier could identify patients associated with improved outcome after combining radiotherapy with hypoxic modification and underlines the relevance of such therapy . The impact of the classifier was limited to HPV-negative tumours PURPOSE Tumor hypoxia is known to be associated with resistance to chemotherapy , radiotherapy , and poorer survival . Recently , it is shown that hypoxia induces the expression of hypoxia-inducible factor-1alpha and 2alpha ( HIF-1alpha and HIF-2alpha ) , which then up-regulates the expression of downstream genes such as carbonic anhydrase IX ( CA IX ) and vascular endothelial growth factor ( VEGF ) . EXPERIMENTAL DESIGN We examined the expression of HIF-1alpha , HIF-2alpha , CA IX , and VEGF by immunohistochemistry in nasopharyngeal carcinoma ( NPC ) biopsies from 90 consecutive patients recruited between 1994 and 1997 in a r and omized controlled trial of chemoradiation in locally advanced NPC and investigated their relationship with survival . RESULTS HIF-1alpha was expressed in 52 of 90 ( 58 % ) , HIF-2alpha in 6 of 89 ( 7 % ) , CA IX in 51 of 90 ( 57 % ) , and VEGF in 54 of 90 ( 60 % ) of tumors . Tumor HIF-1alpha expression correlated significantly with that of CA IX ( P = 0.008 ) and VEGF ( P = 0.003 ) . High tumor HIF-1alpha expression was associated with a trend for poor overall survival ( P = 0.06 ) . Tumors with a positive hypoxic profile ( defined as high expression of both HIF-1alpha and CA9 ) were associated with worse progression-free survival ( P = 0.04 ) . Tumors with both hypoxic and angiogenic profile ( defined as high VEGF expression ) were associated with a worse progression-free survival ( P = 0.0095 ) . CONCLUSION Overexpression of HIF-1alpha , CA IX , and VEGF is common in NPC , which is probably related to hypoxia up-regulated expression involving a HIF-dependent pathway , and is associated with poor prognosis . Targeting the hypoxia pathway may be useful in the treatment of NPC Hypoxia , a common feature of the microenvironment in solid tumors , is associated with resistance to radiotherapy , reduced therapeutic response , and a poorer clinical outcome . In head and neck squamous cell carcinomas ( HNSCC ) , the negative effect of hypoxia on radiotherapy can be counteracted via addition of hypoxic modification to the radiotherapy . To predict which patients harbor hypoxic tumors and would therefore benefit from hypoxic modification , clinical ly applicable methods for pretherapeutic hypoxic evaluation and categorization are needed . In this study , we developed a hypoxia classifier based on gene expression . Through study of xenograft tumors from human squamous cell carcinoma cell lines , we verified the in vivo relevance of previously identified in vitro derived hypoxia-induced genes . We then evaluated a training set of 58 hypoxia-evaluated HNSCCs to generate a gene expression classifier containing 15 genes . This 15-gene hypoxia classifier was vali date d in 323 patients with HNSCC r and omized for hypoxic modification or placebo in combination with radiotherapy . Tumors categorized as hypoxic on the basis of the classifier were associated with a significantly poorer clinical outcome than nonhypoxic tumors . This outcome was improved and equalized to the nonhypoxic tumors by addition of hypoxic modification . Thus , findings show that the classifier attained both prognostic and predictive impact , and its pretherapeutic use may provide a method to identify those patients who will benefit from hypoxic modification of radiotherapy BACKGROUND AND PURPOSE CA IX is suggested to be an endogenous marker of hypoxia in tumours like squamous cell carcinomas of the head and neck ( HNSCC ) . The aim of the present study was to investigate whether CA IX served as a prognostic factor for outcome in a large population of HNSCC and if CA IX was able to discriminate the tumours that did benefit from hypoxic modification with nimorazole . MATERIAL S AND METHODS Paraffin-embedded formalin-fixed pre-treatment tumour tissue was available from 320 of the 414 patients treated in the r and omized DAHANCA 5 protocol with primary radiotherapy+/-the hypoxic radiosensitizer nimorazole . CA IX was measured using immunohistochemistry and results were divided into four groups of CA IX expression : < 1 % , 1 - 10 % , 10 - 30 % and > 30 % of the tumour area with positive membrane staining . Locoregional control and disease-specific survival were used as endpoints . RESULTS Expression of CA IX was not correlated to any of the tumour or patient characteristics investigated . Furthermore , CA IX did not serve as a prognostic marker in the total cohort as well as in the group of 150 patients treated without nimorazole . Finally , no relation was found between the different expression levels of CA IX and the influence of nimorazole when locoregional control or disease-specific survival was used as endpoints . CONCLUSIONS This is to date one of the largest studies of CA IX in HNSCC . The data suggest that CA IX have no prognostic or predictive potential in patients with cancer in the head and neck treated with conventional radiotherapy and concomitant nimorazole Previously , we and others showed that hypoxia‐inducible factor‐1α ( HIF‐1α ) and transcriptionally upregulated Aurora‐A were required for disease progression in several tumors . Here , we address the clinicopathologic value of Aurora‐A and HIF‐1α in locally advanced nasopharyngeal carcinoma ( NPC ) . Aurora‐A and HIF‐1α expression was semiquantitatively evaluated by immunohistochemistry staining in 144 cases from a r and omized controlled trial . Of these patients , 69 received neoadjuvant chemotherapy plus concurrent chemoradiotherapy , and acted as the training set , and 75 cases treated with neoadjuvant chemotherapy plus radiotherapy were used as the testing set to vali date the prognostic effect of Aurora‐A and HIF‐1α . We found that Aurora‐A and HIF‐1α were highly expressed in NPC , but were deficient in normal adjacent epithelia . In the testing set , Aurora‐A overexpression predicted a shortened 5‐year overall survival ( 59.1 % vs 82.5 % , P = 0.024 ) , progression‐free survival ( 44.8 % vs 79.8 % , P = 0.004 ) , and distant metastasis‐free survival ( 43.0 % vs 17.3 % , P = 0.016 ) . Multivariate regression analysis confirmed that Aurora‐A was indeed an independent prognostic factor for death , recurrence , and distant metastasis both in the testing set and overall patients . Moreover , a positive correlation between Aurora‐A and HIF‐1α was detected ( P = 0.037 ) . Importantly , although HIF‐1α did not show any prognostic effect for patient outcome , the subset with Aurora‐A and HIF‐1α co‐overexpression had the poorest overall , progression‐free , and distant metastasis‐free survival ( all P < 0.05 ) . Our results confirmed that Aurora‐A was an independent prognostic factor for NPC . Aurora‐A combined with HIF‐1α refined the risk definition of the patient subset , thus potentially directing locally advanced NPC patients for more selective therapy . ( Cancer Sci , doi : 10.1111/j.1349‐7006.2012.02332.x , 2012 BACKGROUND AND PURPOSE In a phase III trial in patients with advanced stage laryngeal carcinoma comparing ARCON ( accelerated radiotherapy with carbogen breathing and nicotinamide ) to accelerated radiotherapy alone ( AR ) the prognostic and predictive value of CAIX , a hypoxia-associated protein , was investigated . MATERIAL AND METHODS 261 Paraffin embedded tumor biopsies and 79 fresh frozen biopsies from patients entered in the trial were immunohistochemically stained for CAIX . CAIX-fraction and CAIX expression pattern were related to tumor control and patient survival . RESULTS Low CAIX-fraction was prognostic for worse regional control and overall survival in patients treated with AR . Patients with a low CAIX-fraction treated with ARCON had better regional control and metastasis-free survival compared to AR ( RC 97 % vs 71 % , p < 0.01 and MFS 92 % vs 69 % , p = 0.06 ) . Patients with a perinecrotic CAIX staining pattern had a significantly worse local control , metastasis-free and overall survival compared to patients with a diffuse pattern ( 65 % vs 84 % , p = 0.01 , 70 % vs 96 % , p < 0.01 and 42 % vs 71 % , p < 0.01 respectively ) , and this could not be improved with ARCON . After multivariate analysis CAIX pattern and N-stage emerged as significant predictors for metastasis-free survival and overall survival . CONCLUSIONS ARCON improves regional control and metastasis-free survival only in patients with low CAIX expression . The different patterns of CAIX expression suggest different mechanisms of upregulation and have important prognostic value Abstract Purpose / Objective . A phase II clinical trial evaluating the feasibility and outcome of treating locally advanced head and neck squamous cell carcinoma ( HNSCC ) with accelerated radiotherapy , the hypoxic modifier nimorazole and weekly cisplatin . Material and methods . A total of 227 patients with stage III or IV HNSCC of the larynx , oropharynx , hypopharynx , or oral cavity where included between January 2007 and December 2010 . The prescribed radiotherapy ( RT ) dose was 66–68 Gy in 2 Gy fractions , 6 F/W. The hypoxic radiosensitiser nimorazole was given orally at a dose of 1200 mg/m2 before each fraction . Concomitant cisplatin ( 40 mg/m2 ) i.v . was given once a week for a maximum of six cycles . Outcome data were evaluated in terms of loco-regional tumour control ( LRC ) , event-free survival ( EFS ) and overall survival ( OS ) . Morbidity data were evaluated based on the DAHANCA routine registration . Human papillomavirus (HPV)-status was estimated by immunohistochemical staining of p16 . Results . Included were 178 ( 78 % ) men and 49 ( 22 % ) women with a median age of 57 years . All except five patients received RT as prescribed . At least five series of cisplatin was given to 164 ( 72 % ) of the patients , and 149 patients ( 66 % ) received the full dose of nimorazole . The five-year actuarial LRC , EFS and OS rates were 80 % , 67 % and 72 % , respectively . The LRC rates according to site were : oropharynx : 88 % , larynx : 77 % , hypopharynx 72 % and oral cavity 49 % , respectively . HPV/p16 staining was obtained in 141 of the 150 oropharyngeal cancers . Of these , 112 ( 79 % ) were p16 pos and 29 ( 21 % ) were p16 neg . LRC for the p16 neg oropharyngeal cancers was poorer than for the p16 pos ( 74 % vs.
Output:
| Positive expression was often correlated with adverse clinical characteristics , including disease stage and differentiation grade .
In summary , EMH expression was common in HNSCC patients and negatively influenced their prognosis . |
MS212972 | ***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 One of the main strategies to control tuberculosis ( TB ) is to find and treat people with active disease . Unfortunately , the case detection rates remain low in many countries . Thus , we need interventions to find and treat sufficient number of patients to control TB . We investigated whether involving health extension workers ( HEWs : trained community health workers ) in TB control improved smear-positive case detection and treatment success rates in southern Ethiopia . Methodology /Principal Finding We carried out a community-r and omized trial in southern Ethiopia from September 2006 to April 2008 . Fifty-one kebeles ( with a total population of 296 , 811 ) were r and omly allocated to intervention and control groups . We trained HEWs in the intervention kebeles on how to identify suspects , collect sputum , and provide directly observed treatment . The HEWs in the intervention kebeles advised people with productive cough of 2 weeks or more duration to attend the health posts . Two hundred and thirty smear-positive patients were identified from the intervention and 88 patients from the control kebeles . The mean case detection rate was higher in the intervention than in the control kebeles ( 122.2 % vs 69.4 % , p<0.001 ) . In addition , more females patients were identified in the intervention kebeles ( 149.0 vs 91.6 , p<0.001 ) . The mean treatment success rate was higher in the intervention than in the control kebeles ( 89.3 % vs 83.1 % , p = 0.012 ) and more for females patients ( 89.8 % vs 81.3 % , p = 0.05 ) . Conclusions / Significance The involvement of HEWs in sputum collection and treatment improved smear-positive case detection and treatment success rate , possibly because of an improved service access . This could be applied in setting s with low health service coverage and a shortage of health workers . Trial Registration Clinical Trials.gov A r and omized controlled trial was carried out in Pakistan in 1999 to establish the effectiveness of the direct observation component of DOTS programmes . It found no significant differences in cure rates for patients directly observed by health facility workers , community health workers or by family members , as compared with the control group who had self-administered treatment . This paper reports on the social studies which were carried out during and after this trial , to explain these results . They consisted of a survey of all patients ( 64 % response rate ) ; in-depth interviews with a smaller sample of different types of patients ; and focus group discussion s with patients and providers . One finding was that of the 32 in-depth interview patients , 13 ( mainly from the health facility observation group ) failed to comply with their allocated DOT approach during the trial , citing the inconvenience of the method of observation . Another finding was that while patients found the overall TB care approach efficient and economical in general , they faced numerous barriers to regular attendance for the direct observation of drug-taking ( most especially , time , travel costs , ill health and need to pursue their occupation ) . This may be one of the reasons why there was no overall benefit from direct observation in the trial . Provider attitudes were also poor : health facility workers expressed cynical and uncaring views ; community health workers were more positive , but still arranged direct observation to suit their , rather than patients ' , schedules . The article concludes that direct observation , if used , should be flexible and convenient , whether at a health facility close to the patient 's home or in the community . The emphasis should shift in practice from tablet watching towards treatment support , together with education and other adherence measures We assessed the effect of community participation on treatment outcomes for tuberculosis patients undergoing directly-observed therapy , short course ( DOTS ) . From February to December 2001 172 newly diagnosed patients in Baghdad were allocated into 2 treatment groups . The intervention group were visited daily at home for the 2-month initial phase by trained members of the Iraqi Women 's Federation while the control group attended the local health centre for treatment . Cure rates for patients treated at home were significantly better than controls ( 83.7 % versus 68.6 % ) , so too was compliance ( 100.0 % versus 14.0 % ) . Smear conversion rates were significantly better in intervention cases compared with controls at all stages . Default rates were similar in both groups ( 11.6 % versus 10.5 % ) , as was mortality ( 1 patient each ) SETTING Two small urban townships ( compounds ) in Ndola , Zambia , served by an HIV/AIDS home care programme . OBJECTIVE To evaluate the implementation of the directly observed treatment , short-course ( DOTS ) strategy as part of an existing HIV/AIDS home care programme , by comparing TB treatment outcomes in an intervention population ( Chipulukusu compound ) , where implementation of the DOTS strategy is an integral part of the HIV/AIDS home care programme , and in a control population ( Twapia compound ) with district TB services but as yet without coverage by the HIV/AIDS home care programme . DESIGN Prospect i ve evaluation of all new sputum smear-positive TB patients registered in Chipulukusu and Twapia compounds between 1 February 1998 and 30 September 1999 , with documentation of 2-month sputum smear conversion and 8-month treatment outcomes . RESULTS There were 72 new sputum smear-positive pulmonary TB cases in Chipulukusu and 96 in Twapia registered during the study period . In comparing treatment outcomes in Chipulukusu and Twapia , there was no significant difference in treatment success ( cure plus treatment completion ) ( 61 % vs. 48.9 % ) or in deaths ( 22 % vs. 19 % ) . However , cure rate was significantly higher in Chipulukusu than in Twapia ( 54.2 % vs. 20.8 % ) and treatment interruption was significantly lower in Chipulukusu than in Twapia ( 8.3 % vs. 22.9 % ) . CONCLUSION Integration of the DOTS strategy for TB control with an existing HIV/AIDS home care programme led to improved TB programme performance in a compound with a small population ( about 20000 ) . There is scope to scale up this approach so that the entire population of all the compounds in Ndola served by the HIV/AIDS home care programme can benefit from improved TB control 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 Background Directly observed therapy ( DOT ) remains the cornerstone of the global tuberculosis ( TB ) control strategy . Tanzania , one of the 22 high-burden countries regarding TB , changed the first-line treatment regimen to contain rifampicin-containing fixed-dose combination for the full 6 months of treatment . As daily health facility-based DOT for this long period is not feasible for the patient , nor for the health system , Tanzania introduced patient centred treatment ( PCT ) . PCT allows patients to choose for daily DOT at a health facility or at their home by a supporter of choice . The introduction of fixed dose combinations in the intensive and continuation phase made PCT feasible by eliminating the risk of selective drug taking by patients and reducing the number of tablets to be taken . The approach was tested in three districts with the objective to assess the effect of this strategy on TB treatment outcomes Methods Cohort analysis comparing patients treated under the PCT strategy ( registered April-September 2006 ) with patients treated under health-facility-based DOT ( registered April-September 2005 ) . The primary outcome was the cure rate . Differences were assessed by calculating the risk ratios . Associations between characteristics of the supporters and treatment outcomes in the group of patients opting for home-based DOT were assessed through logistic regression . Results In the PCT cohort there were 1208 patients and 1417 were included in the historic cohort . There was no significant difference in cure rates between the cohorts ( risk ratio [ RR ] : 1.06 ; 95 % confidence interval [ CI ] : 0.96 - 1.16 ) . In the PCT cohort , significantly more patients had successful treatment ( cure or treatment completed ; RR : 1.10 ; 95%CI : 1.01 - 1.15 ) . There were no characteristics of supporters that were associated with treatment outcome . Conclusion The PCT approach showed similar cure rates and better treatment success rates compared to daily health-facility DOT . The results indicate that there are no specific prerequisites for the supporter chosen by the patient . The programmatic setting of the study lends strong support for scaling-up of TB treatment observation outside the health facility by HEWs in the health posts and general health workers at health facility were compared along a community-r and omized trial . Costs were analysed from societal perspective in 2007 in US $ using st and ard methods . We prospect ively enrolled smear positive patients , and calculated cost-effectiveness as the cost per patient successfully treated . The total cost for each successfully treated smear-positive patient was higher in health facility ( $ 158.9 ) compared with community ( $ 61.7 ) . Community-based treatment reduced the total , patient and caregiver cost by 61.2 % , 68.1 % and 79.8 % , respectively . Involving HEWs added a total cost of $ 8.80 ( 14.3 % of total cost ) on health service per patient treated in the community . Conclusions / Significance Community-based treatment by HEWs costs only 39 % of what treatment by general health workers costs for similar outcomes . Involving HEWs in TB treatment is a cost effective treatment alternative to the health service , to the patients and the family . There is an economic and public health reason to consider involving HEWs in TB treatment in Ethiopia . However , community-based treatment requires initial investment to start its implementation , training and supervision . Trial Registration Clinical Trials.gov BACKGROUND Tuberculosis remains a major public-health problem in Bangladesh , despite national efforts to improve case identification and treatment compliance . In 1984 , BRAC ( formerly the Bangladesh Rural Advancement Committee ) , a national , non-governmental organisation , began an experimental tuberculosis-control programme in one thana ( subdistrict ) . Community health workers screened villagers for chronic cough and collected sputum sample s for acid-fast bacillus ( AFB ) microscopy ( phase one ) . Positive patients received 12 months of directly observed therapy . Phase two ( 1992 - 94 ) included another nine thanas and , in phase three ( 1995 ) , eight more thanas were included . From 1995 , the treatment was an 8-month oral regimen . METHODS In 1995 - 96 , we analysed all programme data from 1992 to 1995 . First we analysed phases two ( 12-month therapy ) and three ( 8-month therapy ) separately for proportion cured , died , treatment , failed , defaulted , migrated , and referred . Second , we did a cross-sectional survey of tuberculosis cases in more than 9000 r and omly selected households in two phase-two thanas and one non-programme thana , and analysed the follow-up of all patients treated in the programme thanas . FINDINGS In the phase-two analysis , 3497 ( 90 % ) of 3886 cases identified had accepted 12-month treatment . In phase three , all of 1741 identified cases accepted the 8-month regimen . 2833 ( 81.0 % ) and 1496 ( 85.9 % ) in phases two and three , respectively , were cured ; 336 ( 9.6 % ) and 133 ( 7.6 % ) died . The relapse rate 2 or more years after treatment was discontinued was higher than the early relapse rate . The drop-out rate was 3.1 % . In the cross-sectional survey , the prevalence of tuberculosis in the two programme thanas was half of that in the comparison thana , where only government services were available ( 0.07 vs 0.15 per 100 [ corrected ] ) . INTERPRETATION The BRAC tuberculosis-control programme has successfully achieved high rates of case detection and treatment compliance , with a cure rate of at least 85 % and a drop-out rate of 3.1 % . The prevalence survey suggested that at least half of all existing cases had been detected by the programme SETTING An urban district in Dar es Salaam city with a high tuberculosis ( TB ) caseload . OBJECTIVE To evaluate the effectiveness of community-based direct observation of treatment ( D
Output:
| Conclusions Based on this systematic review , CB DOT has a higher treatment success compared to clinic DOT . |
MS212973 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Aims /hypothesisCardiac disease remains the leading cause of mortality in type 2 diabetes , yet few strategies to target cardiac dysfunction have been developed . This r and omised controlled trial aim ed to investigate high intensity intermittent training ( HIIT ) as a potential therapy to improve cardiac structure and function in type 2 diabetes . The impact of HIIT on liver fat and metabolic control was also investigated . Methods Using an online r and om allocation sequence , 28 patients with type 2 diabetes ( metformin and diet controlled ) were r and omised to 12 weeks of HIIT ( n = 14 ) or st and ard care ( n = 14 ) . Cardiac structure and function were measured by 3.0 T MRI and tagging . Liver fat was determined by 1H-magnetic resonance spectroscopy and glucose control by an OGTT . MRI analysis was performed by an observer blinded to group allocation . All study procedures took place in Newcastle upon Tyne , UK . Results Five patients did not complete the study and were therefore excluded from analysis : this left 12 HIIT and 11 control patients for the intention-to-treat analysis . Compared with controls , HIIT improved cardiac structure ( left ventricular wall mass 104 ± 17 g to 116 ± 20 g vs 107 ± 25 g to 105 ± 25 g , p < 0.05 ) and systolic function ( stroke volume 76 ± 16 ml to 87 ± 19 ml vs 79 ± 14 ml to 75 ± 15 ml , p < 0.01 ) . Early diastolic filling rates increased ( 241 ± 84 ml/s to 299 ± 89 ml/s vs 250 ± 44 ml/s to 251 ± 47 ml/s , p < 0.05 ) and peak torsion decreased ( 8.1 ± 1.8 ° to 6.9 ± 1.6 ° vs 7.1 ± 2.2 ° to 7.6 ± 1.9 ° , p < 0.05 ) in the treatment group . Following HIIT , there was a 39 % relative reduction in liver fat ( p < 0.05 ) and a reduction in HbA1c ( 7.1 ± 1.0 % [ 54.5 mmol/mol ] to 6.8 ± 0.9 % [ 51.3 mmol/mol ] vs 7.2 ± 0.5 % [ 54.9 mmol/mol ] to 7.4 ± 0.7 % [ 57.0 mmol/mol ] , p < 0.05 ) . Changes in liver fat correlated with changes in HbA1c ( r = 0.70 , p < 0.000 ) and 2 h glucose ( r = 0.57 , p < 0.004 ) . No adverse events were recorded . Conclusions /interpretationThis is the first study to demonstrate improvements in cardiac structure and function , along with the greatest reduction in liver fat , to be recorded following an exercise intervention in type 2 diabetes . HIIT should be considered by clinical care teams as a therapy to improve cardiometabolic risk in patients with type 2 diabetes . Trial registration : www.is rct n.com 78698481 Funding : Medical Research Council Limited information is available regarding the physiological responses to different types of exercise training in patients with severe chronic obstructive pulmonary disease ( COPD ) . The aim of this study was two fold : firstly , to investigate the physiological response to training at 60 % of achieved peak load in patients with severe COPD ; and secondly to study the effects of interval ( I ) versus continuous ( C ) training in these patients . Twenty-one patients with COPD ( mean+/-SD forced expiratory volume in one second : 37+/-15 % of predicted , normoxaemic at rest ) were evaluated at baseline and after 8 weeks ' training . Patients were r and omly allocated to either I or C training . The training was performed on a cycle ergometer , 5 days a week , 30 min daily . The total work load was the same for both training programmes . C training result ed in a significant increase in oxygen consumption ( V'O2 ) ( 17 % , p<0.05 ) and a decrease in minute ventilation (V'E)/V'O2 ( p<0.01 ) and V'E/carbon dioxide production ( V'CO2 ) ( p<0.05 ) at peak exercise capacity , while no changes in these measures were observed after interval training . During submaximal exercise a significant decrease was observed in lactic acid production , being most pronounced in the C-trained group ( -31 % , p<0.01 versus -20 % , p<0.05 ) . Only in the I-trained group did a significant increase in peak work load ( 17 % , p<0.05 ) and a decrease in leg pain ( p<0.05 ) occur . Training did not result in a significant improvement in lung function , but maximal inspiratory mouth pressure increased in both groups by 10 % ( C : p<0.05 ) and 23 % ( I : p<0.01 ) . The present study shows a different physiological response pattern to interval or continuous training in chronic obstruction pulmonary disease , which might be a reflection of specific training effects in either oxidative or glycolytic muscle metabolic pathways . Further work is required to determine the role of the different exercise programmes and the particular category of patients for whom this might be beneficial We examined the effects of an 8-week exercise intervention on aerobic fitness , and roid and gynoid fat mass , and blood lipids in overweight and obese participants . Twenty-four sedentary participants ( average BMI = 30 ± 2 kg/m2 ; 18 females , 6 males ) were r and omized into either interval training and diet education ( INT group ) , continuous aerobic exercise and diet education ( CON group ) , or diet education only ( DIET group ) . Duration s of exercise sessions were similar ( ∼30 minutes ) , with both exercise groups completing the same amount of work . The INT and CON groups demonstrated significant improvements over time for ( p < 0.01 and p < 0.05 , ES = 1.1 and 1.2 , respectively ) and time to exhaustion on a grade d exercise test ( p < 0.01 and ES = 0.8 for both groups ) . Further , a large effect size ( 0.7 ) was recorded for the loss in and roid fat mass over time in the INT group only Exercise can have anti-inflammatory effects in obesity , but the optimal type and intensity of exercise are not clear . This study compared short-term high-intensity interval training ( HIIT ) with moderate-intensity continuous training ( MICT ) in terms of improvement in cardiorespiratory fitness , markers of inflammation , and glucose control in previously inactive adults at elevated risk of developing type 2 diabetes . Thirty-nine inactive , overweight/obese adults ( 32 women ) were r and omly assigned to 10 sessions over 2 wk of progressive HIIT ( n = 20 , four to ten 1-min sessions at ∼90 % peak heart rate , 1-min rest periods ) or MICT ( n = 19 , 20 - 50 min at ∼65 % peak heart rate ) . Before and 3 days after training , participants performed a peak O2 uptake test , and fasting blood sample s were obtained . Both HIIT ( 1.8 ± 0.4 vs. 1.9 ± 0.4 l/min , pre vs. post ) and MICT ( 1.8 ± 0.5 vs. 1.9 ± 0.5 l/min , pre vs. post ) improved peak O2 uptake ( P < 0.001 ) and lowered plasma fructosamine ( P < 0.05 ) . Toll-like receptor ( TLR ) 4 ( TLR4 ) expression was reduced on lymphocytes and monocytes after both HIIT and MICT ( P < 0.05 ) and on neutrophils after MICT ( P < 0.01 ) . TLR2 on lymphocytes was reduced after HIIT and MICT ( P < 0.05 ) . Plasma inflammatory cytokines were unchanged after training in both groups , but MICT led to a reduction in fasting plasma glucose ( P < 0.05 , 5.9 ± 1.0 vs. 5.6 ± 1.0 mmol/l , pre vs. post ) . Ten days of either HIIT or MICT can improve cardiorespiratory fitness and glucose control and lead to reductions in TLR2 and TLR4 expression . MICT , which involved a longer duration of exercise , may be superior for reducing fasting glucose Background — Exercise training reduces the symptoms of chronic heart failure . Which exercise intensity yields maximal beneficial adaptations is controversial . Furthermore , the incidence of chronic heart failure increases with advanced age ; it has been reported that 88 % and 49 % of patients with a first diagnosis of chronic heart failure are > 65 and > 80 years old , respectively . Despite this , most previous studies have excluded patients with an age > 70 years . Our objective was to compare training programs with moderate versus high exercise intensity with regard to variables associated with cardiovascular function and prognosis in patients with postinfa rct ion heart failure . Methods and Results — Twenty-seven patients with stable postinfa rct ion heart failure who were undergoing optimal medical treatment , including & bgr;-blockers and angiotensin-converting enzyme inhibitors ( aged 75.5±11.1 years ; left ventricular [ LV ] ejection fraction 29 % ; & OV0312;o2peak 13 mL · kg−1 · min−1 ) were r and omized to either moderate continuous training ( 70 % of highest measured heart rate , ie , peak heart rate ) or aerobic interval training ( 95 % of peak heart rate ) 3 times per week for 12 weeks or to a control group that received st and ard advice regarding physical activity . & OV0312;o2peak increased more with aerobic interval training than moderate continuous training ( 46 % versus 14 % , P<0.001 ) and was associated with reverse LV remodeling . LV end-diastolic and end-systolic volumes declined with aerobic interval training only , by 18 % and 25 % , respectively ; LV ejection fraction increased 35 % , and pro-brain natriuretic peptide decreased 40 % . Improvement in brachial artery flow-mediated dilation ( endothelial function ) was greater with aerobic interval training , and mitochondrial function in lateral vastus muscle increased with aerobic interval training only . The MacNew global score for quality of life in cardiovascular disease increased in both exercise groups . No changes occurred in the control group . Conclusions — Exercise intensity was an important factor for reversing LV remodeling and improving aerobic capacity , endothelial function , and quality of life in patients with postinfa rct ion heart failure . These findings may have important implication s for exercise training in rehabilitation programs and future studies Increasing evidence suggests that high-intensity training ( HIT ) is a time-efficient exercise strategy to improve fitness . HIT has never been explored in neuromuscular diseases , likely because it may seem counterintuitive . A single session of high-intensity exercise has been studied without signs of muscle damage in facioscapulohumeral muscular dystrophy type 1 ( FSHD1 ) . We aim ed to determine whether HIT is safe and effective in FSHD1 in a r and omized , controlled parallel study . Untrained adults with genetically verified FSHD1 ( n = 13 ) able to perform cycle-ergometer exercise were r and omized to 8 weeks of supervised HIT ( n = 6 ) ( 3 × 10-min cycle-ergometer-HIT/week ) or 8 weeks of usual care ( n = 7 ) . Following this , all participants performed 8 weeks of unsupervised HIT ( 3 × 10-min cycle-ergometer-HIT/week ) . Primary outcome was fitness , maximal oxygen uptake/min/kg body weight . Furthermore , workload , 6-min walk distance , 5-time sit-to-st and time , muscle strength , and daily activity levels were measured . Pain , fatigue , and plasma-CK were monitored . Twelve patients completed the r and omized part of the study . Plasma-CK levels and pain scores were unaffected by HIT . Supervised HIT improved fitness ( 3.3 ml O2/min/kg , CI 1.2–5.5 , P < 0.01 , n = 6 , NNT = 1.4 ) . Unsupervised HIT also improved fitness ( 2.0 ml O2/min/kg , CI 0.1–3.9 , P = 0.04 , n = 4 ) . There was no training effect on other outcomes . Patients preferred HIT over strength and moderate-intensity aerobic training . It may seem counterintuitive to perform HIT in muscular dystrophies , but this RCT shows that regular HIT is safe , efficacious , and well liked by moderately affected patients with FSHD1 , which suggests that HIT is a feasible method for rehabilitating patients with FSHD1 BACKGROUND Peak oxygen uptake ( Vo(2peak ) ) strongly predicts mortality in cardiac patients . We compared the effects of aerobic interval training ( AIT ) versus moderate continuous training ( MCT ) on Vo(2peak ) and quality of life after coronary artery bypass grafting ( CABG ) . METHODS Fifty-nine CABG patients were r and omized to either AIT at 90 % of maximum heart rate or MCT at 7
Output:
| Conclusions HIIT elicits improvements in objective measures of CRF within 8 wk in diseased cohorts compared with no intervention .
When compared with MCT , HIIT imparts statistically significant additional improvements in measures of CRF , with clinical ly important additional improvements in V˙O2peak in cardiovascular patients . |
MS212974 | ***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: Previous papers in this series on evidence -based dentistry have discussed the first 2 steps in seeking answers to clinical problems formulating a clear question and strategically search ing for evidence . The next step , critical appraisal of the evidence , is made easier if one underst and s the basic concepts of clinical research design . The strongest design , especially for questions related to therapeutic or preventive interventions , is the r and omized , controlled trial . Questions relating to diagnosis , prognosis and causation are often studied with observational , rather than experimental , research design s. The strongest study design should be used whenever possible . Rules have been established to grade research evidence . This paper , the fourth in the series , presents an overview of research methodology most commonly used in the dental literature OBJECTIVES To compare learning outcomes and perceptions of facilitator behaviours and small-group process in problem-based learning ( PBL ) groups led by students and those led by faculty . DESIGN A prospect i ve , Latin-square cross-over design was employed . Second-year medical students participated in 11 PBL cases over the course of the academic year . For each case , half the student groups were led by faculty and the other half by a student group member selected r and omly to serve in the facilitator role . Learning outcomes were assessed by performance on objective examinations covering factual material s pertinent to the case . Perceptions of facilitator behaviours and of group functioning were assessed with a question naire completed at the end of each individual case . Focus-group discussion s were held to gain more in-depth information about student perceptions and experience . Student-led sessions were observed at r and om by the investigators . SETTING A state-supported , US medical school with a hybrid lecture-based and problem-based curriculum . SUBJECTS One hundred and twenty-seven second-year medical students and 30 basic science and clinical faculty . RESULTS No differences were detected in student performance on the objective evaluation based on whether the facilitator was a faculty member or peer group member , nor were there any differences in the perceptions of group process . Students gave peer facilitators slightly higher ratings in the second semester of the experiment . In the focus-group discussion s , students voiced a general preference for student-led groups because they felt they were more efficient . Observation and focus-group reports suggest that groups led by students sometimes took short cuts in the PBL process . CONCLUSION In a hybrid lecture- and PBL-based curriculum , student performance on objective examinations covering PBL material s is unaffected by the status of the facilitator ( student vs. faculty ) . However , in peer-facilitated groups , students sometimes took short cuts in the PBL process that may undermine some of the intended goals of PBL Since the publication of Physicians for the Twenty-First Century —‘‘the GPEP Report ’ ’ of 1984 , medical educators have identified the need for physicians to become lifelong learners . Part of the impetus for this conclusion arises from several studies that have demonstrated that knowledge and /or competence of physicians decline as a function of time since graduation ; the evidence indicates the cause to be failure to acquire new knowledge rather than a tendency to forget previously learned material . Thus , physicians need to be trained to identify the relevant medical literature ( i.e. , information-seeking skills ) and to apply ‘ ‘ critical appraisal ’’ techniques to analyze potentially useful articles culled from the literature search . There is little published evidence that educational interventions around critical appraisal teaching in undergraduate or postgraduate medical curricula impact in a sustained way the knowledge of epidemiologic principles or the critical application of current research information for clinical decision making . In considering the impact on conceptual knowledge , one could argue that there is a lack of vali date d tools available for evaluating critical appraisal skills ; alternatively , the format of instruction , timing in the curriculum , and duration of instruction may be at fault . More important , studies have not addressed the issue of whether the demonstration of mastery of particular critical appraisal skills can be related to clinical decision making . Ultimately , such mastery becomes largely irrelevant if it does not translate into better judgment . The authors of this study were concerned that , despite the inclusion in the first-year undergraduate curriculum of several focused objectives surrounding critical appraisal in the domain of clinical epidemiology , feedback from clinical faculty suggested that students had only rudimentary knowledge of the application of these principles at the end of the first year . In contrast to this feedback , problem-based learning ( PBL ) is believed to hold the potential to equip graduates with the skills to learn after graduation . In fact , several studies have shown significant differences between students of PBL and students of conventional curricula in the use of recently published medical literature . With this inconsistency in mind , two experimental questions were asked
Output:
| Problem-based learning and evidence -based health care interventions increased student knowledge of medical topics and their ability to search , evaluate , and appraise medical literature .
Dental students in a problem-based learning curriculum , emphasizing evidence -based practice s , scored higher on the NDB I ( National Dentistry Boards , Part I ) than students in traditional curricula .
Considering the strength of evidence in the review ed literature , we concluded that an evidence -based approach to clinical care is effective |
MS212975 | ***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: Codeine is widely used in combination with acetaminophen and aspirin for the management of mild to moderate pain . However , there are few controlled clinical trials of single-entity codeine in chronic cancer pain . The purpose of this study was to evaluate the clinical efficacy and safety of controlled-release codeine given every 12 hr in patients with cancer pain . Thirty-five patients with chronic cancer pain were r and omized in a double-blind crossover study to controlled-release ( CR ) codeine or placebo , for 7 days each . Pain intensity was assessed at 0800 hr and 2000 hr using a visual analogue scale ( VAS ) and a five-point categorical scale , and the use of " rescue " acetaminophen-plus-codeine ( 300 mg/30 mg every 4 hr as needed ) was recorded . Thirty patients completed the study ( 17 male , 13 female ; mean age , 64.4 + /- 9.8 years ) with a mean daily CR codeine dose of 277 + /- 77 mg ( range , 200 - 400 mg ) . CR codeine treatment result ed in significantly lower overall VAS pain intensity scores ( 22 + /- 18 mm versus 36 + /- 20 mm , P = 0.0001 ) , categorical pain intensity scores ( 1.2 + /- 0.8 versus 1.8 + /- 0.8 , P = 0.0001 ) , and pain scores when assessed by day of treatment and by time of day . Daily " rescue " analgesic consumption was significantly lower on CR codeine , compared to placebo treatment ( 2.2 + /- 2.3 versus 4.6 + /- 2.8 tablets per day , P = 0.0001 ) . Both patients and investigators preferred CR codeine to placebo ( 80 % versus 3 % , P = 0.0014 and 73 % versus 7 % , P = 0.0160 , respectively ) . These data indicate that CR codeine , given every 12 hr results in significant reductions in pain intensity and the use of " rescue " acetaminophen-plus-codeine in patients with cancer pain . CR codeine provides the benefits of a flexible single entity codeine formulation and the convenience of 12-hr duration of action , which allows patients uninterrupted sleep and improved compliance To compare the effectiveness and safety of controlled-release ( CR ) oxycodone tablets with immediate-release ( IR ) oxycodone in patients with chronic cancer pain , a multicenter , r and omized , double-blind , parallel-group study was performed in 111 patients with cancer pain . Patients were treated with 6 to 12 tablets or capsules of fixed-combination opioid/nonopioid analgesics per day at study entry . Patients received 30 mg of CR oxycodone tablets every 12 hr or 15 mg of IR oxycodone four times daily for 5 days . No titration or supplemental analgesic medications were permitted . The mean ( + /- SE ) baseline pain intensity ( 0 = none , 1 = slight , 2 = moderate , 3 = severe ) was 1.5 + /- 0.1 for the CR oxycodone-treated group and 1.3 + /- 0.1 for the group given IR oxycodone ( P > 0.05 ) . The 5-day mean pain intensity was 1.4 + /- 0.1 and 1.1 + /- 0.1 for the CR and IR groups , respectively ( P > 0.05 ) . Discontinuation rates were equivalent ( 33 % ) . There was no significant difference between treatment groups in the incidence of adverse events . This study demonstrates that cancer pain patients given 6 to 12 tablets or capsules of fixed-dose combination analgesics can be equally well treated with CR oxycodone administered every 12 hr or IR oxycodone four times daily at the same total daily dose . CR oxycodone offers the benefits of twice daily dosing Summary Sustained-release morphine ( MST ) given by the rectal route was compared with oral MST in an open r and omised cross-over trial in ten patients with cancer who received stable doses of MST . No significant difference was found in the areas under the curve of the concentration-time profiles ( AUC ) following oral or rectal administration for parent morphine . The AUCs determine for morphine-6-glucuronide ( M6 G ) and morphine-3-glucuronide ( M3 G ) after oral administration were approximately twice those obtained following rectal administration . The maximal concentration achieved was lower and the time to maximal concentration was longer following rectal administration for morphine , M6 G and M3 G . The relative mean arrival times following rectal administration were significantly longer for morphine and M3 G but not for M6 G . These findings suggest slower absorption but less first-pass metabolism of MST after rectal administration . No significant difference was noted between the oral and the rectal route in measurements on visual-analogue scales for pain or side effects . We recommend the rectal route as being suitable for MST administration when the oral route is no longer available . In changing from oral to rectal administration , the same dose and dose interval may be used , but dose adjustment may be needed & NA ; A controlled trial of diamorphine ( diacetylmorphine , heroin ) and morphine is reported in which the two drugs were administered regularly by mouth in individually determined effective analgesic doses . Elixirs contained cocaine hydrochloride 10 mg/dose ; other drugs were prescribed when indicated clinical ly . 699 patients entered the trial and , of these , 146 crossed from diamorphine to morphine , or vice versa , after about two weeks using an oral potency ratio of 1.5/1 determined in a pilot trial . Additional medication and survival were closely similar in both treatment groups . In the female crossover patients , no difference was noted in relation either to pain or the other symptoms evaluated . On the other h and , male crossover patients experienced more pain , and were more depressed , while receiving diamorphine . In these , the potency ratio of diamorphine to morphine appeared to be less than 1.5/1 . If this is allowed for , then the difference in mood is probably not significant . Compared with male patients , fewer females required a dose of 10 mg or more , but more were prescribed an anxiolytic . The ability to do without a 2 a.m. dose appeared to be related more to the size of the dose than to gender or treatment . It is concluded that , provided allowance is made for the difference in potency , morphine is a satisfactory substitute for orally administered diamorphine . However , when injections are necessary , the greater solubility of its hydrochloride gives diamorphine an important practical advantage over morphine , especially when large doses are required Immediate‐release oral morphine , given every four hours in individually titrated doses , is effective in the control of severe cancer pain . To evaluate the analgesic efficacy of a controlled‐release morphine sulfate preparation , MS Contin tablets ( MSC , Purdue Frederick , Toronto , Ontario , Canada ) , after a single dose and under steady‐state conditions , the authors compared MSC administered every 12 hours with morphine oral solution ( MOS ) administered every 4 hours in 17 adult cancer patients with chronic severe pain . In the single‐dose evaluation , in which the patients were r and omly assigned to receive MSC or MOS , there were no significant differences in analgesic efficacy or requirement for supplemental morphine between the two treatments . With both preparations , pain severity ratings increased toward the end of the 12‐hour , single‐dose observation period and were higher than the pain scores reported after dose titration . In the steady‐state evaluation , which was a r and omized crossover comparison , both preparations provided effective pain control with minimal side effects . There was no significant difference between MSC and MOS in overall pain scores or La pain scores analyzed by time of day and day of therapy . In conclusion , that an individualized twice‐daily regimen of MSC is as effective as 4‐hourly MOS for the control of chronic severe cancer pain . The twice‐daily regimen has several advantages : it allows an uninterrupted night ' sleep , it is substantially more convenient , and it can be expected to reduce both medication errors and noncompliance & NA ; Oral transmucosal fentanyl citrate ( OTFC ® ; Actiq ® ) is a drug delivery formulation used for management of breakthrough cancer pain . Previous studies with open‐label comparisons indicated OTFC was more effective than patients ’ usual opioid for breakthrough pain . The objective of this study was to compare OTFC and morphine sulfate immediate release ( MSIR ® ) for management of breakthrough pain in patients receiving a fixed scheduled opioid regimen . This double‐blind , double‐dummy , r and omized , multiple crossover study was conducted at 19 US university‐ and community‐based hospitals and clinics and comprised 134 adult ambulatory cancer patients . Patients were receiving a fixed scheduled opioid regimen equivalent to 60–1000 mg/day oral morphine or 50–300 & mgr;g/h transdermal fentanyl , were using a ‘ successful ’ MSIR dose ( 15–60 mg ) as defined by entry criteria , and were experiencing 1–4 episodes of breakthrough pain per day . In open‐label fashion , OTFC was titrated such that a single unit ( 200–1600 & mgr;g ) provided adequate pain relief with acceptable side effects . Successfully titrated patients entered the double‐blind phase of the study and received ten prenumbered sets of r and omized capsules and oral transmucosal units . Five sets were the successful OTFC dose paired with placebo capsules , and five sets were placebo OTFC paired with capsules containing the successful MSIR dose . Patients took one set of study medication for each episode of target breakthrough pain . Pain intensity ( PI ) , pain relief ( PR ) and global performance of medication ( GP ) scores were recorded . Pain intensity differences ( PID ) were calculated and 15‐min PID was the primary efficacy variable . Adverse events were recorded . Sixty‐nine percent of patients ( 93/134 ) found a successful dose of OTFC . OTFC yielded outcomes ( PI , PID , and PR ) at all time points that were significantly better than MSIR . GP also favored OTFC and more patients opted to continue with OTFC than MSIR following the study . Somnolence , nausea , constipation , and dizziness were the most common drug‐associated side effects . In conclusion , OTFC was more effective than MSIR in treating breakthrough cancer pain Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size Although the oral route is the preferred method of opioid therapy in patients with cancer pain , many patients will require an alternate route of analgesic administration at some point during the trajectory of their illness . This study compared the efficacy and safety of a novel , controlled-release suppository of morphine ( MSC-R ) and controlled-release morphine tablets ( MSC-T ) in patients with cancer pain . In a double-blind crossover study , 27 patients with cancer pain were r and omized to receive MSC-R or MSC-T every 12 hours for 7 days each , using a 1:1 analgesic equivalence ratio . Pain intensity was assessed using a visual analog scale ( VAS ) and the Present Pain Intensity Index of the McGill Pain Question naire . Nausea and sedation were also assessed with a VAS . Pharmacodynamic assessment s were made by the patient at 8:00 AM , 12:00 PM , 4:00 PM , and 8:00 PM and rescue morphine use recorded in a daily diary . There were no significant differences between MSC-R and MSC-T in overall scores for pain intensity VAS , ordinal pain intensity , and sedation . There was a small but significant difference in overall nausea VAS score in favor of MSC-R. Mean daily rescue analgesic use did not differ significantly during between treatment with MSC-R and MSC-T. MSC-R provides pain control comparable
Output:
| We found no direct evidence that opioids affected patient consciousness , appetite or thirst when used to treat cancer pain .
However , somnolence , dry mouth , and anorexia were common adverse events in people with cancer pain treated with morphine , fentanyl , oxycodone , or codeine . |
MS212976 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: CONTEXT Evidence to support antibiotic treatment for acute rhinosinusitis is limited , yet antibiotics are commonly used . OBJECTIVE To determine the incremental effect of amoxicillin treatment over symptomatic treatments for adults with clinical ly diagnosed acute rhinosinusitis . DESIGN , SETTING , AND PARTICIPANTS A r and omized , placebo-controlled trial of adults with uncomplicated , acute rhinosinusitis were recruited from 10 community practice s in Missouri between November 1 , 2006 , and May 1 , 2009 . INTERVENTIONS Ten-day course of either amoxicillin ( 1500 mg/d ) or placebo administered in 3 doses per day . All patients received a 5- to 7-day supply of symptomatic treatments for pain , fever , cough , and nasal congestion to use as needed . MAIN OUTCOME MEASURES The primary outcome was improvement in disease-specific quality of life after 3 to 4 days of treatment assessed with the Sinonasal Outcome Test-16 ( minimally important difference of 0.5 units on a 0 - 3 scale ) . Secondary outcomes included the patient 's retrospective assessment of change in sinus symptoms and functional status , recurrence or relapse , and satisfaction with and adverse effects of treatment . Outcomes were assessed by telephone interview at days 3 , 7 , 10 , and 28 . RESULTS A total of 166 adults ( 36 % male ; 78 % with white race ) were r and omized to amoxicillin ( n = 85 ) or placebo ( n = 81 ) ; 92 % concurrently used 1 or more symptomatic treatments ( 94 % for amoxicillin group vs 90 % for control group ; P = .34 ) . The mean change in Sinonasal Outcome Test-16 scores was not significantly different between groups on day 3 ( decrease of 0.59 in the amoxicillin group and 0.54 in the control group ; mean difference between groups of 0.03 [ 95 % CI , -0.12 to 0.19 ] ) and on day 10 ( mean difference between groups of 0.01 [ 95 % CI , -0.13 to 0.15 ] ) , but differed at day 7 favoring amoxicillin ( mean difference between groups of 0.19 [ 95 % CI , 0.024 to 0.35 ] ) . There was no statistically significant difference in reported symptom improvement at day 3 ( 37 % for amoxicillin group vs 34 % for control group ; P = .67 ) or at day 10 ( 78 % vs 80 % , respectively ; P = .71 ) , whereas at day 7 more participants treated with amoxicillin reported symptom improvement ( 74 % vs 56 % , respectively ; P = .02 ) . No between-group differences were found for any other secondary outcomes . No serious adverse events occurred . CONCLUSION Among patients with acute rhinosinusitis , a 10-day course of amoxicillin compared with placebo did not reduce symptoms at day 3 of treatment . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00377403 In this double-blind , parallel-group , multicenter study , 169 patients with symptoms of maxillary sinusitis but without radiographically confirmed empyema ( pus ) were r and omly assigned to receive either 500 mg azithromycin once daily for 3 days ( 87 patients ) or placebo daily for 3 days ( 82 patients ) . Nasal secretion , maxillary tenderness and pain , nasal obstruction , general malaise , and hyposmia were assessed at the start of the study and on days 4 , 11 , and 25 of treatment . After 11 days 58 % of the patients in the azithromycin group were cured versus 31 % in the placebo group ; after 25 days the cure rate was 79 % versus 67 % , respectively . When both cure and improvement were considered , the corresponding figures after day 25 were 90 % and 88 % , respectively . Adverse events , predominantly gastrointestinal , occurred in 24 ( 27 % ) of the azithromycin-treated patients and in 15 ( 18 % ) of those treated with placebo , but the difference was not statistically significant . There was a difference in efficacy in favor of azithromycin in the treatment of rhinitis with symptoms of maxillary sinusitis but without radiological signs of empyema ( pus ) . Antibiotics should only be used to alleviate symptoms in patients with moderate to severe symptoms , as the results after 25 days for both improvement and cure are equal . In the treatment of acute rhinitis with symptoms and signs of maxillary sinusitis but without empyema , treatment with azithromycin seems to result in a better cure rate after 10–12 days when compared with placebo OBJECTIVE To compare the efficacy of amoxicillin vs placebo in patients with an acute upper respiratory tract infection and purulent rhinorrhea . STUDY DESIGN Double-blind r and omized placebo-controlled trial . POPULATION The 416 patients included from 69 family practice s were 12 years or older , presenting with acute upper respiratory complaints , and having a history of purulent rhinorrhea and no signs of complications of sinusitis . OUTCOMES MEASURED Therapy success ( disappearance of symptoms that most greatly affected the patient 's health ) at day 10 and duration of general illness , pain , and purulent rhinorrhea . RESULTS Therapy was successful in 35 % of patients with amoxicillin and in 29 % of patients with placebo ( relative risk [ RR ] 1.14 , 95 % confidence interval [ CI ] , 0.92 - 1.42 ) . There was no effect on duration of general illness or pain . Duration of purulent rhinorrhea was shortened by amoxicillin ( 9 days vs 14 for clearing of purulent rhinorrhea in 75 % of patients ; P = .007 ) . Diarrhea was more frequent with amoxicillin ( 29 % vs 19 % , RR 1.28 , 95 % CI , 1.05 - 1.57 ) . No complications were reported . One patient ( 0.5 % ) receiving amoxicillin and 7 ( 3.4 % ) receiving placebo discontinued trial therapy because of exacerbation of symptoms ( RR 0.25 , 95 % CI 0.04 - 1.56 , P = .07 ) . All 8 patients recovered with antibiotic therapy . CONCLUSIONS Amoxicillin has a beneficial effect on purulent rhinorrhea caused by an acute infection of the nose or sinuses but not on general recovery . The practical implication is that all such patients , whatever the suspected diagnosis , can be safely treated with symptomatic therapy and instructed to return if symptoms worsen CONTEXT Acute sinusitis is a common clinical problem that usually results in a prescription for antibiotics but the role of antibiotics is debated . Anti-inflammatory drugs such as topical steroids may be beneficial but are under research ed . OBJECTIVE To determine the effectiveness of amoxicillin and topical budesonide in acute maxillary sinusitis . DESIGN , SETTING , AND PATIENTS A double-blind , r and omized , placebo-controlled factorial trial of 240 adults ( aged > or = 16 years ) with acute nonrecurrent sinusitis ( had > or = 2 diagnostic criteria : purulent rhinorrhea with unilateral predominance , local pain with unilateral predominance , purulent rhinorrhea bilateral , presence of pus in the nasal cavity ) at 58 family practice s ( 74 family physicians ) between November 2001 and November 2005 . Patients were r and omized to 1 of 4 treatment groups : antibiotic and nasal steroid ; placebo antibiotic and nasal steroid ; antibiotic and placebo nasal steroid ; placebo antibiotic and placebo nasal steroid . INTERVENTION A dose of 500 mg of amoxicillin 3 times per day for 7 days and 200 mug of budesonide in each nostril once per day for 10 days . MAIN OUTCOME MEASURES Proportion clinical ly cured at day 10 using patient symptom diaries and the duration and severity of symptoms . RESULTS The proportions of patients with symptoms lasting 10 or more days were 29 of 100 ( 29 % ) for amoxicillin vs 36 of 107 ( 33.6 % ) for no amoxicillin ( adjusted odds ratio , 0.99 ; 95 % confidence interval , 0.57 - 1.73 ) . The proportions of patients with symptoms lasting 10 or more days were 32 of 102 ( 31.4 % ) for topical budesonide vs 33 of 105 ( 31.4 % ) for no budesonide ( adjusted odds ratio , 0.93 ; 95 % confidence interval , 0.54 - 1.62 ) . Secondary analysis suggested that nasal steroids were significantly more effective in patients with less severe symptoms at baseline . CONCLUSION Neither an antibiotic nor a topical steroid alone or in combination was effective as a treatment for acute sinusitis in the primary care setting . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N60825437 BACKGROUND Sinusitis is the fifth most common reason for patients to visit primary care physicians , yet clinical outcomes relevant to patients are seldom studied . OBJECTIVE To determine whether patients with purulent rhinitis , " sinusitis-type symptoms , " improved with antibiotics . Second , to examine a clinical prediction rule to provide preliminary validation data . METHODS Prospect i ve clinical trial , with double-blinded placebo controlled r and omization . The setting was a suburb of Washington , DC , from Oct 1 , 2001 , to March 31 , 2003 . All participants were 18 years or older , presenting to a family practice clinic with a complaint of sinusitis and with pus in the nasal cavity , facial pressure , or nasal discharge lasting longer than 7 days . The main outcome measures were resolution of symptoms within a 14-day follow-up period and the time to improvement ( days ) . RESULTS After exclusion criteria , 135 patients were r and omized to either placebo ( n=68 ) or amoxicillin ( n=67 ) for 10 days . Intention-to-treat analyses showed that 32 ( 48 % ) of the amoxicillin group vs 25 ( 37 % ) of the placebo group ( P=.26 ) showed complete improvement by the end of the 2-week follow-up period ( relative risk=1.3 ; 95 % confidence interval [ CI ] , 0.87 - 1.94 ] ) . Although the rates of improvement were not statistically significantly different at the end of 2 weeks , the amoxicillin group improved significantly earlier , in the course of treatment , a median of 8 vs 12 days , than did the placebo group ( P=.039 ) . CONCLUSION For most patients with sinusitis-type complaints , no improvement was seen with anti-biotics over placebo . For those who did improve , data suggested there is a subgroup of patients who may benefit from antibiotics Objective . Although antimicrobial treatment for children with acute sinusitis is used commonly , it is unclear whether it offers significant clinical benefit . The purpose of this study was to evaluate the effectiveness of antimicrobial treatments for acute sinusitis as they are used in community pediatric practice . Methods . We conducted a r and omized , placebo-controlled trial in 3 community pediatric practice s in St Louis , Missouri . A total of 188 patients who were between the ages of 1 and 18 years and who had had 10 to 28 days of persistent sinus symptoms and a clinical diagnosis of acute sinusitis were r and omized to receive 14 days of amoxicillin ( 40 mg/kg/d in 3 daily doses ) , amoxicillin-clavulanate ( amoxicillin 45 mg/kg/d in 2 daily doses ) , or placebo . Change in sinus symptoms was assessed both by a quantitative symptom score ( the S5 score ) and subjectively by the parent . Secondary outcomes included adverse effects of treatment and recurrence or relapse of sinus symptoms . Outcomes were assessed by telephone interviews over a 2-month period . Results . Of the 161 patients who were included in the analysis , 58 received amoxicillin , 48 received amoxicillin-clavulanate , and 55 received placebo . Day 14 improvement rates were 79 % , 81 % , and 79 % , respectively . There were no differences in the 14-day change in S5 score among treatment groups . The rates of adverse events ( amoxicillin , 19 % ; amoxicillin-clavulanate , 11 % ; placebo , 10 % ) , relapse ( amoxicillin , 12 % ; amoxicillin-clavulanate , 13 % ; placebo , 13 % ) , and recurrence ( amoxicillin , 9 % ; amoxicillin-clavulanate , 13 % ; placebo , 13 % ) of sinus symptoms were similar among treatment groups . Conclusion . Neither
Output:
| The potential benefit of antibiotics in the treatment of clinical ly diagnosed acute rhinosinusitis needs to be seen in the context of a high prevalence of adverse events .
Taking into account antibiotic resistance and the very low incidence of serious complications , we conclude that there is no place for antibiotics for the patient with clinical ly diagnosed , uncomplicated acute rhinosinusitis . |
MS212977 | ***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 Peanut allergy is a major public health problem that affects 1 % of the population and has no effective therapy . OBJECTIVE To examine the safety and efficacy of oral desensitization in peanut-allergic children in combination with a brief course of anti-IgE mAb ( omalizumab [ Xolair ] ) . METHODS We performed oral peanut desensitization in peanut-allergic children at high risk for developing significant peanut-induced allergic reactions . Omalizumab was administered before and during oral peanut desensitization . RESULTS We enrolled 13 children ( median age , 10 years ) , with a median peanut-specific IgE level of 229 kU(A)/L and a median total serum IgE level of 621 kU/L , who failed an initial double-blind placebo-controlled food challenge at peanut flour doses of 100 mg or less . After pretreatment with omalizumab , all 13 subjects tolerated the initial 11 desensitization doses given on the first day , including the maximum dose of 500 mg peanut flour ( cumulative dose , 992 mg , equivalent to > 2 peanuts ) , requiring minimal or no rescue therapy . Twelve subjects then reached the maximum maintenance dose of 4000 mg peanut flour per day in a median time of 8 weeks , at which point omalizumab was discontinued . All 12 subjects continued on 4000 mg peanut flour per day and subsequently tolerated a challenge with 8000 mg peanut flour ( equivalent to about 20 peanuts ) , or 160 to 400 times the dose tolerated before desensitization . During the study , 6 of the 13 subjects experienced mild or no allergic reactions , 5 subjects had grade 2 reactions , and 2 subjects had grade 3 reactions , all of which responded rapidly to treatment . CONCLUSIONS Among children with high-risk peanut allergy , treatment with omalizumab may facilitate rapid oral desensitization and qualitatively improve the desensitization process Background : Oral immunotherapy ( OIT ) is an effective experimental food allergy treatment that is limited by treatment withdrawal and the frequent reversibility of desensitization if interrupted . Newly diagnosed preschool children may have clinical and immunological characteristics more amenable to treatment . Objective : We sought to test the safety , effectiveness , and feasibility of early OIT ( E‐OIT ) in the treatment of peanut allergy . Methods : We enrolled 40 children aged 9 to 36 months with suspected or known peanut allergy . Qualifying subjects reacted to peanut during an entry food challenge and were block‐r and omized 1:1 to receive E‐OIT at goal maintenance doses of 300 or 3000 mg/d in a double‐blinded fashion . The primary end point , sustained unresponsiveness at 4 weeks after stopping early intervention oral immunotherapy ( 4‐SU ) , was assessed by double‐blinded , placebo‐controlled food challenge either upon achieving 4 prespecified criteria , or after 3 maintenance years . Peanut‐specific immune responses were serially analyzed . Outcomes were compared with 154 matched st and ard‐care controls . Results : Of 40 consented subjects , 3 ( 7.5 % ) did not qualify . Overall , 29 of 37 ( 78 % ) in the intent‐to‐treat analysis achieved 4‐SU ( 300‐mg arm , 17 of 20 [ 85 % ] ; 3000 mg , 12 of 17 [ 71 % ] , P = .43 ) over a median of 29 months . Per‐ protocol , the overall proportion achieving 4‐SU was 29 of 32 ( 91 % ) . Peanut‐specific IgE levels significantly declined in E‐OIT‐treated children , who were 19 times more likely to successfully consume dietary peanut than matched st and ard‐care controls , in whom peanut‐specific IgE levels significantly increased ( relative risk , 19.42 ; 95 % CI , 8.7‐43.7 ; P < .001 ) . Allergic side effects during E‐OIT were common but all were mild to moderate . Conclusions : At both doses tested , E‐OIT had an acceptable safety profile and was highly successful in rapidly suppressing allergic immune responses and achieving safe dietary re introduction Background : Peanut oral immunotherapy is a promising approach to peanut allergy , but reactions are frequent , and some patients can not be desensitized . The anti‐IgE medication omalizumab ( Xolair ; Genentech , South San Francisco , Calif ) might allow more rapid peanut updosing and decrease reactions . Objective : We sought to evaluate whether omalizumab facilitated rapid peanut desensitization in highly allergic patients . Methods : Thirty‐seven subjects were r and omized to omalizumab ( n = 29 ) or placebo ( n = 8) . After 12 weeks of treatment , subjects underwent a rapid 1‐day desensitization of up to 250 mg of peanut protein , followed by weekly increases up to 2000 mg . Omalizumab was then discontinued , and subjects continued on 2000 mg of peanut protein . Subjects underwent an open challenge to 4000 mg of peanut protein 12 weeks after stopping study drug . If tolerated , subjects continued on 4000 mg of peanut protein daily . Results : The median peanut dose tolerated on the initial desensitization day was 250 mg for omalizumab‐treated subjects versus 22.5 mg for placebo‐treated subject . Subsequently , 23 ( 79 % ) of 29 subjects r and omized to omalizumab tolerated 2000 mg of peanut protein 6 weeks after stopping omalizumab versus 1 ( 12 % ) of 8 receiving placebo ( P < .01 ) . Twenty‐three subjects receiving omalizumab versus 1 subject receiving placebo passed the 4000‐mg food challenge . Overall reaction rates were not significantly lower in omalizumab‐treated versus placebo‐treated subjects ( odds ratio , 0.57 ; P = .15 ) , although omalizumab‐treated subjects were exposed to much higher peanut doses . Conclusion : Omalizumab allows subjects with peanut allergy to be rapidly desensitized over as little as 8 weeks of peanut oral immunotherapy . In the majority of subjects , this desensitization is sustained after omalizumab is discontinued . Additional studies will help clarify which patients would benefit most from this approach BACKGROUND Peanut oral immunotherapy , using a variety of approaches , has been previously shown to induce desensitization in peanut-allergic subjects , but no products have been approved for clinical use by regulatory agencies . OBJECTIVE We performed the first phase 2 multicentered study to assess the safety and efficacy of AR101 , a novel oral biologic drug product . METHODS A r and omized , double-blind , placebo-controlled trial was conducted at 8 US centers . Eligible subjects were 4 to 26 years old , sensitized to peanut , and had dose-limiting symptoms to ≤143 mg of peanut protein in a screening double-blind , placebo-controlled food challenge ( DBPCFC ) . Subjects were r and omized 1:1 to daily AR101 or placebo and gradually up-dosed from 0.5 to 300 mg/day . The primary endpoint was the proportion of subjects in each arm able to tolerate ≥443 mg ( cumulative peanut protein ) at exit DBPCFC with no or mild symptoms . RESULTS Fifty-five subjects ( 29 AR101 , 26 placebo ) were enrolled . In the intention-to-treat analysis , 23 of 29 ( 79 % ) and 18 of 29 ( 62 % ) AR101 subjects tolerated ≥443 mg and 1043 mg at exit DBPCFC , respectively , versus 5 of 26 ( 19 % ) and 0 of 26 ( 0 % ) placebo subjects ( both P < .0001 ) . Compared with placebo , AR101 significantly reduced symptom severity during exit DBPCFCs and modulated peanut-specific cellular and humoral immune responses . Gastrointestinal ( GI ) symptoms were the most common treatment-related adverse events ( AEs ) in both groups , with 6 AR101 subjects ( 21 % ) withdrawing , 4 of those due primarily to recurrent GI AEs . CONCLUSIONS In this study , AR101 demonstrated an acceptable safety profile and demonstrated clinical activity as a potential immunomodulatory treatment option in peanut-allergic children over the age of 4 , adolescents , and young adults BACKGROUND Although promising results have emerged regarding oral immunotherapy ( OIT ) and sublingual immunotherapy ( SLIT ) for the treatment of peanut allergy ( PA ) , direct comparisons of these approaches are limited . OBJECTIVE This study was conducted to compare the safety , efficacy , and mechanistic correlates of peanut OIT and SLIT . METHODS In this double-blind study children with PA were r and omized to receive active SLIT/placebo OIT or active OIT/placebo SLIT . Doses were escalated to 3.7 mg/d ( SLIT ) or 2000 mg/d ( OIT ) , and subjects were rechallenged after 6 and 12 months of maintenance . After unblinding , therapy was modified per protocol to offer an additional 6 months of therapy . Subjects who passed challenges at 12 or 18 months were taken off treatment for 4 weeks and rechallenged . RESULTS Twenty-one subjects aged 7 to 13 years were r and omized . Five discontinued therapy during the blinded phase . Of the remaining 16 , all had a greater than 10-fold increase in challenge threshold after 12 months . The increased threshold was significantly greater in the active OIT group ( 141- vs 22-fold , P = .01 ) . Significant within-group changes in skin test results and peanut-specific IgE and IgG4 levels were found , with overall greater effects with OIT . Adverse reactions were generally mild but more common with OIT ( P < .001 ) , including moderate reactions and doses requiring medication . Four subjects had sustained unresponsiveness at study completion . CONCLUSION OIT appeared far more effective than SLIT for the treatment of PA but was also associated with significantly more adverse reactions and early study withdrawal . Sustained unresponsiveness after 4 weeks of avoidance was seen in only a small minority of subjects Background : Reports on oral immunotherapy ( OIT ) for anaphylactic food allergy are lacking . We investigated the efficacy and safety of peanut OIT for anaphylactic patients . Methods : We enrolled 22 peanut anaphylactic patients who underwent OIT between 2011 and 2013 , all of whom demonstrated anaphylaxis during a baseline double-blind , placebo-controlled food challenge . After starting in-hospital OIT , participants gradually increased ingestion to 795 mg of peanut protein per day at home and then took a maintenance dose ( 795 mg ) daily . After 3 asymptomatic months , participants underwent an oral food challenge ( OFC ) of 795 mg after 2 weeks of peanut avoidance to confirm sustained unresponsiveness . The historical control group consisted of 11 patients with anaphylaxis by OFC and underwent the second OFC after 2 years . Results : All patients ( 22/22 ) achieved desensitization by 8 months after starting OIT and completed the protocol within 2 years . Two years later , 15/22 patients ( 68.1 % ) in the OIT group achieved sustained unresponsiveness , whereas only 2 ( 18.1 % ) in the control group passed the second OFC . After 2 years , the median peanut-specific IgE had significantly decreased ( from 38.5 to 12.4 kUA/L ) in the OIT group , but not in the control group . Median peanut- and Ara h 2-specific IgG4 in the OIT group had significantly increased from baseline after 1 month . The adverse reaction rate per ingestion was 43 % in hospital and 5 % at home . Three patients received adrenaline at the hospital and 2 at home . Conclusions : These data suggest that for patients with peanut anaphylaxis , OIT can increase the threshold and support achieving sustained unresponsiveness with relative safety Background Peanut allergy is severe and rarely resolves BACKGROUND Open-label oral immunotherapy ( OIT ) protocol s have been used to treat small numbers of patients with peanut allergy . Peanut OIT has not been evaluated in double-blind , placebo-controlled trials . OBJECTIVE To investigate the safety and effectiveness of OIT for peanut allergy in a double-blind , placebo-controlled study . METHODS In this multicenter study , children ages 1 to 16 years with peanut allergy received OIT with peanut flour or placebo . Initial escalation , build-up , and maintenance phases were followed by an oral food challenge ( OFC ) at approximately 1 year . Titrated skin prick tests ( SPTs ) and laboratory studies were performed at regular intervals . RESULTS Twenty-eight subjects were enrolled in the study . Three peanut OIT subjects withdrew early in the study because of allergic side effects . During the double-blind , placebo-controlled food challenge , all remaining peanut OIT
Output:
| Use of a rush treatment phase and targeting a higher maintenance dose were associated with a higher risk and frequency of epinephrine use , while using co-treatments in addition to POIT was associated with a lower risk of treatment discontinuation due to adverse events .
While adverse events to POIT are common , this study provides promising explorative evidence that certain modifications to existing treatment protocol s could significantly improve treatment outcomes |
MS212978 | ***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: Pilot studies for phase III trials - which are comparative r and omized trials design ed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas . Also commonly know as " feasibility " or " vanguard " studies , they are design ed to assess the safety of treatment or interventions ; to assess recruitment potential ; to assess the feasibility of international collaboration or coordination for multicentre trials ; to increase clinical experience with the study medication or intervention for the phase III trials . They are the best way to assess feasibility of a large , expensive full-scale study , and in fact are an almost essential pre-requisite . Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies . The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including : 1 ) the general reasons for conducting a pilot study ; 2 ) the relationships between pilot studies , proof-of-concept studies , and adaptive design s ; 3 ) the challenges of and misconceptions about pilot studies ; 4 ) the criteria for evaluating the success of a pilot study ; 5 ) frequently asked questions about pilot studies ; 7 ) some ethical aspects related to pilot studies ; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format OBJECTIVE To test the feasibility , acceptability , and potential efficacy of after-school dance classes and a family-based intervention to reduce television viewing , thereby reducing weight gain , among African-American girls . DESIGN Twelve-week , 2-arm parallel group , r and omized controlled trial . SETTING Low-income neighborhoods . PARTICIPANTS Sixty-one 8 - 10-year-old African-American girls and their parents/guardians . INTERVENTIONS The treatment intervention consisted of after-school dance classes at 3 community centers , and a 5-lesson intervention , delivered in participants ' homes , and design ed to reduce television , videotape , and video game use . The active control intervention consisted of disseminating newsletters and delivering health education lectures . MAIN OUTCOME MEASURES Implementation and process measures , body mass index , waist circumference , physical activity measured by accelerometry , self-reported media use , and meals eaten with TV . RESULTS Recruitment and retention goals were exceeded . High rates of participation were achieved for assessment s and intervention activities , except where transportation was lacking . All interventions received high satisfaction ratings . At follow up , girls in the treatment group , as compared to the control group , exhibited trends toward lower body mass index ( adjusted difference = -.32 kg/m2 , 95 % confidence interval [ CI ] -.77 , .12 ; Cohen 's d = .38 st and ard deviation units ) and waist circumference ( adjusted difference = -.63 cm , 95 % CI -1.92 , .67 ; d = .25 ) ; increased after-school physical activity ( adjusted difference = 55.1 counts/minute , 95 % CI -115.6 , 225.8 ; d = .21 ) ; and reduced television , videotape , and video game use ( adjusted difference = -4.96 hours/week , 95 % CI -11.41 , 1.49 ; d = .40 ) . The treatment group reported significantly reduced household television viewing ( d = .73 , P = .007 ) and fewer dinners eaten while watching TV ( adjusted difference = -1.60 meals/week , 95 % CI -2.99 , -.21 ; d = .59 ; P = .03 ) . Treatment group girls also reported less concern about weight ( d = .60 ; P = .03 ) , and a trend toward improved school grade s ( d = .51 ; P = .07 ) . CONCLUSIONS This study confirmed the feasibility , acceptability , and potential efficacy of using dance classes and a family-based intervention to reduce television viewing , thereby reducing weight gain , in African-American girls To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design OBJECTIVE The objective of the current study was to examine the effectiveness of a multidisciplinary weekly family-based behavioral group delivered via telemedicine to rural areas , compared with a st and ard physician visit intervention . METHODS A r and omized controlled trial was conducted with 58 rural children and their families comparing a family-based behavioral intervention delivered via telemedicine to a structured physician visit condition . Outcome measures included child body mass index z-score ( BMI z ) , 24-hr dietary recalls , accelerometer data , Child Behavior Checklist , Behavioral Pediatrics Feeding Assessment Scale , and feasibility and fidelity . RESULTS Child BMI z outcomes were not statistically different between the 2 groups ( F = 0.023 , p = .881 ) . Improvements in BMI z , nutrition , and physical activity were seen for both groups . CONCLUSIONS Both telemedicine and structured physician visit may be feasible and acceptable methods of delivering pediatric obesity treatment to rural children Summary Background Although childhood overweight and obesity prevalence has increased substantially worldwide in the past three decades , scarce evidence exists for effective preventive strategies . We aim ed to establish whether a school-based intervention for children aged 9–10 years would prevent excessive weight gain after 24 months . Methods This pragmatic cluster r and omised controlled trial of the Healthy Lifestyles Programme ( HeLP ) , a school-based obesity prevention intervention , was done in 32 schools in southwest Engl and . All state-run primary and junior schools in Devon and Plymouth ( UK ) with enough pupils for at least one year-5 class were eligible . Schools were assigned ( 1:1 ) using a computer-generated sequence to either intervention or control , stratified by the number of year-5 classes ( one vs more than one ) and the proportion of children eligible for free school meals ( < 19 % [ the national average ] vs ≥19 % ) . HeLP was delivered to year-5 children ( ages 9–10 years ) over 1 year , and included dynamic and interactive activities such as physical activity workshops , education sessions delivered by teachers with short homework tasks , drama sessions , and setting goals to modify behaviour ( with parental support and one-to-one discussion s with HeLP coordinators ) . The primary outcome was change in body-mass index ( BMI ) st and ard deviation score ( SDS ) between baseline and 24 months , analysed in children with BMI data available for both timepoints . This study is registered with the International St and ard R and omised Controlled Trial register , number IS RCT N15811706 , and the trial status is complete . Findings Between March 21 , 2012 , and Sept 30 , 2013 , 32 eligible schools with 1324 children were recruited , of which 16 schools ( 676 children ) were r and omly assigned to the HeLP intervention and 16 schools ( 648 children ) to control . All schools that began the trial completed the intervention , and 1244 children ( 628 in intervention group and 616 in control group ) had BMI data at both baseline and 24 months for the primary outcome analysis . Mean BMI SDS was 0·32 ( SD 1·16 ) at baseline and 0·35 ( 1·25 ) at 24 months in the intervention group , and 0·18 ( 1·14 ) at baseline and 0·22 ( 1·22 ) at 24 months in the control group . With adjustment for school-level clustering , baseline BMI scores , sex , cohort , and number of year-5 classes and socioeconomic status of each school , the mean difference in BMI SDS score ( intervention – control ) at 24 months was −0·02 ( 95 % CI −0·09 to 0·05 ) , p=0·57 . One parent reported an adverse event related to their child 's eating and activity behaviours , but agreed for the child to continue trial participation after discussion with the chief investigator . Interpretation Despite a theoretically informed and extensively piloted intervention that achieved high levels of engagement , follow-up , and fidelity of delivery , we found no effect of the intervention on preventing overweight or obesity . Although schools are an ideal setting in which to deliver population -based interventions , school-based interventions might not be sufficiently intense to affect both the school and the family environment , and hence the weight status of children . Future research should focus on more upstream determinants of obesity and use whole-systems approaches . Funding UK National Institute for Health Research , Public Health Research Programme Background The bias toward immediate gratification is associated with maladaptive eating behaviors and has been cross-sectionally and prospect ively related to obesity . Engaging in episodic future thinking , which involves mental self-projection to pre-experience future events , reduces this bias and energy intake in overweight/obese adults and children . To examine how episodic future thinking can be incorporated into clinical interventions , a Web-based system was created to provide training for adults and children in their everyday lives . Objective Our study examined the technical feasibility , usability , and acceptability of a Web-based system that is accessible by mobile devices and adapts episodic future thinking for delivery in family-based obesity interventions . Methods We recruited 20 parent-child dyads ( N=40 ) from the surrounding community and r and omized to episodic future thinking versus a nutritional information thinking control to test the feasibility of a 4-week Web-based intervention . Parents were 44.1 ( SD 7.8 ) years of age with BMI of 34.2 ( SD 6.8 ) kg/m2 . Children were 11.0 ( SD 1.3 ) years of age with BMI percentile of 96.0 ( SD 1.8 ) . Families met weekly with a case manager for 4 weeks and used the system daily . Adherence was collected through the Web-based system , and perceived acceptance of the Web-based system was assessed postintervention . Measurements of body composition and dietary intake were collected at baseline and after the 4 weeks of intervention . Results All 20 families completed the intervention and attended all sessions . Results showed parents and children had high adherence to the Web-based system and perceived it to be easy to use , useful , and helpful . No differences between conditions were found in adherence for parents ( P=.65 ) or children ( P=.27 ) . In addition , results suggest that basic nutrition information along with episodic future thinking delivered through our Web-based system may reduce energy intake and weight . Conclusions We showed that our Web-based system is an accepted technology and a feasible utility . Furthermore , results provide initial evidence that our system can be incorporated into family-based treatments targeting behaviors related to weight control . These results show promising utility in using our Web-based system in interventions This study explored a community-based after-school program ’s effect on obesity in minority children . Study participants included 178 third through fifth grade rs ( 47 % Latino , 25 % Asian , and 18 % African-American ) enrolled in America SCORES Bay Area . Outcomes were attendance , change in fitness ( 20-meter shuttle test ) , and body mass index ( BMI ) z-score over eight months . At baseline , 52 percent of children were overweight or obese . Children attended SCORES > 4 days/week and fitness significantly improved ( p < 0.01 ) . BMI z-score decreased by 0.04 ( p = 0.10 ) overall , and by 0.05 ( p = 0.08 ) among obese children , but increased among African-American children . These results suggest that SCORES increases fitness and may improve BMI in some minority children . Effect modification by race may relate to differential growth patterns or engagement in SCORES . These findings suggest community-based programs could effectively address obesity . A r and omized trial of the SCORES program is warranted to rigorously examine this type of after-school program ’s impact on child health To
Output:
| Pre-emptive avoidance of RGBs during the initial testing of an intervention may diminish the voltage drop between pilot and larger efficacy/effectiveness trials and enhance the odds of successful translation |
MS212979 | ***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 : Uremic toxins play a pivotal role in the development of systemic complications of chronic kidney disease ( CKD ) , which are largely mediated by the activation of the immune system . Triggers of inflammation in CKD are largely unknown and strategies aim ing to reduce circulating lig and s that could start the inflammatory response are potentially important . In the present study , we investigated the impact of sevelamer hydrochloride treatment in reducing endotoxemia and inflammation in a group of hemodialysis ( HD ) patients . Material and Methods : HD patients , who were converted from calcium carbonate treatment to sevelamer according to KDOQI guidelines , were included and prospect ively followed for 6 months . Systemic inflammation was evaluated by serum ultra-high-sensitivity C-reactive protein ( hsCRP ) using an automated immunoturbidimetric assay . Endotoxin was measured using Limulus amebocyte lysate chromogenic endpoint assay . All the analyses were performed immediately before conversion and after 6 months of treatment . Results : After the exclusion of patients discontinuing the treatment , 20 patients ( mean dialysis time 12 ± 4 months on HD , age 52 ± 2 years , 38 % males , 11 % diabetics ) were included in the analysis . No significant changes were observed in Ca , P and PTH levels , while a reduction in cholesterol levels was seen . Plasma concentration of hsCRP and endotoxin significantly decreased after 6 months of conversion to sevelamer compared with baseline . Conclusion : We conclude that sevelamer treatment leads to a decrease in hsCRP levels , which was accompanied by a parallel decrease in endotoxemia , suggesting that endotoxemia may contribute to the systemic inflammation in HD patients , which was partially reduced by the use of sevelamer AIMS No conventional phosphate binder is entirely satisfactory for the treatment of hyperphosphatemia in patients with end-stage renal disease ( ESRD ) . Consequently , there is a need for new agents . One such agent is lanthanum carbonate ( La ) . This large-scale study compares the safety of La with st and ard therapy ( any approved phosphate binder ) in patients who were treated for up to 2 years . Efficacy , having previously been demonstrated , was a secondary endpoint . MATERIAL S AND METHODS After washout , patients were r and omized to receive La ( n=682 ) or their pre- study phosphate binder ( n=677 ) . Over a 6-week period , La was titrated to a maximum daily dose of 3000 mg elemental lanthanum ( serum phosphorus target levels for titration were < or = 5.9 mg/dl ( 1.90 mmol/l ) ) . Safety assessment s included adverse events ( AEs ) , full laboratory parameters and blood profiles . Efficacy assessment s included serum phosphorus , calcium , calcium x phosphorus product and parathyroid hormone ( PTH ) levels . RESULTS Average treatment exposure was greater in the st and ard therapy group ( 501.4 days ) than in the La group ( 370.3 days ) because st and ard therapy patients who switched or combined treatments were allowed to continue in the study . The most common AEs were gastrointestinal . The incidences of AEs in the La and treatment exposure-corrected st and ard therapy groups were nausea , 37 versus 29 % ; vomiting , 27 versus 22 % and diarrhea ( 24 % in each group ) . Hypercalcemia that was reported as an AE ( La versus treatment exposure-corrected st and ard therapy ) occurred in 4.3 % and 8.4 % of patients , respectively . There was no indication of liver toxicity , suppression of erythropoiesis or changes in the mini-mental state examination . Over 2 years , phosphorus control was similar in both groups ; in the La group , however , serum calcium was lower and serum PTH levels were maintained in the range recommended by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative ( K/DOQI ) . CONCLUSIONS The 2-year tolerability and efficacy of La are similar to those seen with st and ard therapy , although lower serum calcium levels and improved PTH levels were observed in the La group . These results support La as a viable new option for the management of hyperphosphatemia in ESRD AIMS High serum phosphorus levels are a common problem in patients receiving long-term dialysis treatment . Lanthanum carbonate ( Fosrenol ) is a new non-aluminum , non-calcium phosphate binder developed for the treatment of hyperphosphatemia in patients with end-stage renal disease ( ESRD ) . We report data from a recent trial , which , for the first time , assessed the efficacy and tolerability of lanthanum carbonate treatment , compared with placebo , in Chinese patients with ESRD . PATIENTS AND METHODS Following a one- to three-week washout phase and a four-week , open-label lanthanum carbonate dose-titration phase , male and female hemodialysis patients were r and omized ( 1:1 ) to receive either lanthanum carbonate or placebo for four weeks . The primary efficacy parameter of the study was the control of serum phosphorus levels ( < or = 1.8 mmol/l [ < or = 5.6 mg/dl ] ) . Secondary endpoints included the profile of serum phosphorus during titration and parathyroid hormone , calcium , and calcium x phosphorus ( Ca x P ) product levels . The safety and tolerability of lanthanum carbonate were assessed by monitoring adverse events throughout the study . RESULTS Mean serum phosphorus level at the end of washout was 2.5 + /- 0.5 mmol/l ( 7.7 + /- 1.5 mg/dl ; n=73 ) , and there was no evidence of a difference in levels between the treatment groups pre-r and omization . At the end of the study , lanthanum carbonate-treated patients had significantly lower phosphorus levels ( 1.6 + /- 0.5 mmol/l [ 5.1 + /- 1.5 mg/dl ] ; n=30 ) than those receiving placebo ( 2.3 + /- 0.4 mmol/l [ 7.2 + /- 1.3 mg/dl ] ; n=31 ; p < 0.001 ) . In addition , a significantly higher proportion of patients receiving lanthanum carbonate had controlled serum phosphorus levels ( 60 % ) compared with the placebo group ( 10 % ; p < 0.001 ) . Ca x P product levels were also significantly lower in the lanthanum carbonate group at the end of r and omized treatment ( p < 0.001 ) . Lanthanum carbonate was well tolerated ; only one serious adverse event was reported , which was unrelated to treatment . CONCLUSIONS Lanthanum carbonate was shown to be an effective and well-tolerated phosphate binder for the treatment of hyperphosphatemia in Chinese patients with ESRD . This finding supports the results of previous US and European studies , which have also shown that lanthanum carbonate treatment effectively controls serum phosphorus levels Background : Control of serum phosphate over the long term is essential in patients with end-stage renal disease . Six-month and 2-year extensions to a 6-month study evaluated the long-term safety , tolerability and efficacy of the new phosphate binder lanthanum carbonate . Methods : Patients who participated in a 6-month , r and omized trial comparing lanthanum carbonate with calcium carbonate were eligible for a 24-week , open-label extension . Lanthanum carbonate-treated patients continued taking their established maintenance dose ( ‘ continued-lanthanum group ’ ) and calcium carbonate-treated patients switched to lanthanum carbonate , 375–3,000 mg/day ( ‘ switch group ’ ) . Patients could also enter a further 2-year extension . Efficacy parameters , including serum phosphate , were monitored . Results : Mean serum phosphate was ∼1.80 mmol/l throughout the trial . The percentage of patients with controlled serum phosphate ( ≤1.80 mmol/l ) after the 6-month extension was 63.3 and 58.4 % in the continued-lanthanum and switch groups , respectively ; after the 2-year extension , 54.4 % of patients had controlled serum phosphate . After discontinuation of calcium carbonate and initiation of lanthanum carbonate , the hypercalcemia incidence was 2.7 % , compared with 20.2 % during the double-blind phase . Calcium × phosphate product was maintained at an acceptable level . Lanthanum carbonate was well tolerated ; adverse events were mild/moderate and mainly gastrointestinal . Conclusions : Lanthanum carbonate maintains effectiveness with continued tolerability for up to 3 years Background Serum phosphorus control is critical for chronic kidney disease ( CKD ) 5D patients . Currently , clinical profile for an oral phosphorus binder in the mainl and Chinese population is not available . Objective To establish the efficacy , safety , and tolerability of lanthanum carbonate in CKD 5D patients . Design Multicenter , r and omized , double blind , placebo-controlled study . A central r and omization center used computer generated tables to allocate treatments . Setting Twelve tertiary teaching hospitals and medical university affiliated hospitals in mainl and China . Participants Overall , 258 hemodialysis or continuous ambulatory peritoneal dialysis ( CAPD ) adult patients were enrolled . InterventionAfter a 0–3-week washout period and a 4-week lanthanum carbonate dose-titration period , 230 patients were r and omized 1:1 to receive lanthanum carbonate ( 1500 mg-3000 mg ) or placebo for a further 4-week maintenance phase . Main outcome measures Efficacy and safety of lanthanum carbonate to achieve and maintain target serum phosphorus concentrations were assessed . Results In the titration phase , serum phosphorus concentrations of all patients decreased significantly . About three-fifths achieved target levels without significantly disturbing serum calcium levels . At the end of the maintenance period , the mean difference in serum phosphorus was significantly different between the lanthanum carbonate and placebo-treated groups ( 0.63±0.62 mmol/L vs. 0.15±0.52 mmol/L , P < 0.001 ) . The drug-related adverse effects were mild and mostly gastrointestinal in nature . Conclusion Lanthanum carbonate is an efficacious and well-tolerated oral phosphate binder with a mild AE profile in hemodialysis and CAPD patients . This agent may provide an alternative for the treatment of hyperphosphatemia in CKD 5D patients in mainl and China . Trial registration No. BACKGROUND The majority of patients with end-stage renal disease on dialysis are hyperphosphataemic . Lanthanum carbonate has been shown to be a highly effective phosphate binder in pre- clinical studies . A 4-week , open-label , dose-titration trial was conducted to assess the ability of lanthanum carbonate to control phosphate levels in patients with chronic renal failure . METHODS This preliminary study was of 6 weeks duration : 2 weeks of washout followed by 4 weeks of dose titration . Patients ( n = 59 ) were titrated on the basis of weekly serum phosphate levels from a daily dose of 375 mg lanthanum carbonate to a maximum dose of 2250 mg . Patients were maintained on the dose that controlled serum phosphate to between 1.30 and 1.80 mmol/l ( 4.03 - 5.58 mg/dl ) . Serum phosphate levels represented the main efficacy assessment . Safety was also evaluated . RESULTS Most patients were successfully titrated to 1500 and 2250 mg lanthanum/day ( mean dose at end of titration : 1278 mg ) . At completion of the study 70 % of patients achieved a serum phosphate of < or=1.80 mmol/l . The use of lanthanum carbonate in patients undergoing continuous ambulatory peritoneal dialysis or haemodialysis was generally well tolerated . CONCLUSIONS Lanthanum carbonate , a new non-aluminium , non-calcium phosphate binder , effectively reduces serum phosphate levels . Results of longer-term efficacy and safety studies are awaited with interest BACKGROUND Atherosclerosis and vascular calcification ( VC ) progression in chronic kidney disease is favored by disturbances of mineral metabolism . We compared the effect of phosphate binder lanthanum ( La ) carbonate with sevelamer-HCl on atherosclerosis , VC and bone structure and function in mice with chronic renal failure ( CRF ) . METHODS Apolipoprotein E-deficient ( apoE(-/- ) ) mice were r and omized to one non-CRF and three CRF groups , fed with st and ard diet ( one non-CRF and one CRF ) or diet supplemented with either 3 % lanthanum carbonate ( La3 % ) or 3 % sevelamer-HCl ( Sev3 % ) . RESULTS Both La3 % and Sev3 % supplemented CRF mice displayed a decrease of serum phosphorus , calcification at both intimal and medial aortic sites and atherosclerosis . This was associated with a reduction of plaque Type I collagen expression by both binders and of positive nitrotyrosine staining in response to sevelamer-HCl only . Increased mineral apposition and bone formation rates in unsupplemented CRF mice were reduced by Sev3 % but not by La3 % . CONCLUS
Output:
| The limited number of trials was insufficient to show the superiority of LC over other treatments in lowering vascular calcification or cardiovascular events and in improving bone morphology , bone metabolism , or bone turn-over parameters .
LC decreased the serum phosphorus level and calcium × phosphate product ( Ca × P ) as compared to placebo .
LC , calcium carbonate ( CC ) , and sevelamer hydrochloride ( SH ) were comparable in terms of controlling the serum phosphorus , Ca × P product , and intact parathyroid hormone ( iPTH ) levels .
However , LC result ed in a lower serum calcium level and a higher bone-specific alkaline phosphatase level compared with CC .
LC had higher total cholesterol and low-density lipoprotein ( LDL ) cholesterol levels compared with SH .
LC-treated patients appeared to have a higher rate of vomiting and lower risk of hypercalcemia , diarrhea , intradialytic hypotension , cramps or myalgia , and abdominal pain .
Meta- analysis showed no significant difference in the incidence of other side effects .
Accumulation of LC in blood and bone was below toxic levels .
Conclusions LC has high efficacy in lowering serum phosphorus and iPTH levels without increasing the serum calcium .
Current evidence does not show a higher rate of adverse effects for LC compared with other treatments , except for a higher incidence of vomiting .
Moreover , LC accumulation in blood and bone was below toxic levels . |
MS212980 | ***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 Compulsory admission to psychiatric hospitals may be distressing , disruptive to patients and families , and associated with considerable cost to the health service . Improved patient experience and cost reductions could be realised by providing cost-effective crisis planning services . Methods Economic evaluation within a multi-centre r and omised controlled trial comparing Joint Crisis Plans ( JCP ) plus treatment as usual ( TAU ) to TAU alone for patients aged over 16 , with at least one psychiatric hospital admission in the previous two years and on the Enhanced Care Programme Approach register . JCPs , containing the patient 's treatment preferences for any future psychiatric emergency , are a form of crisis intervention that aim to mitigate the negative consequences of relapse , including hospital admission and use of coercion . Data were collected at baseline and 18-months after r and omisation . The primary outcome was admission to hospital under the Mental Health Act . The economic evaluation took a service perspective ( health , social care and criminal justice services ) and a societal perspective ( additionally including criminal activity and productivity losses ) . Findings The addition of JCPs to TAU had no significant effect on compulsory admissions or total societal cost per participant over 18-months follow-up . From the service cost perspective , however , evidence suggests a higher probability ( 80 % ) of JCPs being the more cost-effective option . Exploration by ethnic group highlights distinct patterns of costs and effects . Whilst the evidence does not support the cost-effectiveness of JCPs for White or Asian ethnic groups , there is at least a 90 % probability of the JCP intervention being the more cost-effective option in the Black ethnic group . Interpretation The results by ethnic group are sufficiently striking to warrant further investigation into the potential for patient gain from JCPs among black patient groups . Trial Registration Current Controlled Trials IS RCT BACKGROUND Psychiatric emergency situations ( PES ) are of high importance to the German prehospital physician-based emergency medical system . So far , however , no prospect i ve studies regarding the incidence of PES have been performed , neither have effects of training programs on diagnostic and therapeutic accuracy been studied . METHOD The protocol s of two emergency medical services ( EMS ) were collected and analyzed prospect ively . Emergency physicians ( EPs ) in Kaiserslautern ( KL ) attended a st and ardized educational program and underwent daily supervision . EPs in Homburg ( HOM ) had not been informed about the study . In KL , sociodemographic variables were collected . An investigator who was not involved in the individual EMS mission assessed the correct classification of PES . RESULTS Among all calls for an EP , 11.8 % were classified as PES . There was no difference between the two centers . Correct classification of PES in KL was significantly higher than that in HOM ( 94.3 % vs. 80.6 % ) . Documentation of suicidal behavior was deficient in both centers . EPs in KL gave verbal crisis intervention significantly more often , administered less medication overall , and dispensed more specific drugs in psychotic disorders and significantly less drugs in substance abuse disorders . Patients were more often treated at the scene and were less often transported to a hospital . Some sociodemographic variables were associated with psychiatric morbidity of treatment . CONCLUSION Accounting for 12 % of all missions , psychiatric emergencies are a frequent reason for calls for EPs , equaling trauma-related and neurological emergencies . The most frequent reasons for calls were alcohol intoxication , states of agitation and suicidal behavior . The diagnostic and therapeutic accuracy of EPs may be improved with a concise st and ardized teaching program BACKGROUND Women 's crisis houses have been developed in the UK as a less stigmatising and less institutional alternative to traditional psychiatric wards . AIMS To examine the effectiveness and cost-effectiveness of women 's crisis houses by first examining the feasibility of a pilot patient-preference r and omised controlled trial ( PP- RCT ) design ( IS RCT N20804014 ) . METHOD We used a PP- RCT study design to investigate women presenting in crisis needing informal admission . The four study arms were the patient preference arms of women 's crisis house or hospital admission , and r and omised arms of women 's crisis house or hospital admission . RESULTS Forty-one women entered the r and omised arms of the trial ( crisis house n = 19 , wards n = 22 ) and 61 entered the patient-preference arms ( crisis house n = 37 , ward n = 24 ) . There was no significant difference in outcomes ( symptoms , functioning , perceived coercion , stigma , unmet needs or quality of life ) or costs for any of the groups ( r and omised or preference arms ) , but women who obtained their preferred intervention were more satisfied with treatment . CONCLUSIONS Although the sample sizes were too small to allow definite conclusions , the results suggest that when services are able to provide interventions preferred by patients , those patients are more likely to be satisfied with treatment . This pilot study provides some evidence that women 's crisis houses are as effective as traditional psychiatric wards , and may be more cost-effective Background : A&E departments are key points of contact for many people with mental health problems . Various models of care have been developed in A&E departments for delivering mental health services , but few have been assessed for effectiveness . The present study aim ed to assess the impact of a dedicated A&E psychiatric nurse service on several outcomes relevant to patients and clinicians . Methods : A crossover design was used to introduce a dedicated psychiatric nurse service ( comprising four experienced community psychiatric nurses ) into two busy UK A&E departments . St and ardised assessment s were completed for each patient , and a r and om sample of these independently assessed for quality . Data were also collected on the number of patients assessed , psychiatric nurse time employed , waiting times , onward referrals , repeat attendances , patient satisfaction , and staff views . Results : A&E staff referred about a third of patients judged to have mental health problems to the psychiatric nurse service ; approximately half of those assessed had a psychiatric history . On average , assessment s took 60 min and over 90 % of the formulated management plans were judged appropriate by independent assessors . The psychiatric nurse intervention had little impact on waiting times or satisfaction levels for mental health patients , although there was evidence of a change in onward referral patterns . Comment : Psychiatric nurse assessment services have been introduced in many A&E departments , although the evidence base for the effectiveness of this development is not well established . This study presents evidence that psychiatric nurses can provide an accurate assessment and referral service with advantages for patient care Background Mental health patients can feel anxious about losing the support of staff and patients when discharged from hospital and often discontinue treatment , experience relapse and readmission to hospital , and sometimes attempt suicide . The benefits of peer support in mental health services have been identified in a number of studies with some suggesting clinical and economic gains in patients being discharged . Methods This pilot r and omised controlled trial with economic evaluation aim ed to explore whether peer support in addition to usual aftercare for patients during the transition from hospital to home would increase hope , reduce loneliness , improve quality of life and show cost effectiveness compared with patients receiving usual aftercare only , with follow-up at one and three-months post-discharge . Results A total of 46 service users were recruited to the study ; 23 receiving peer support and 23 in the care-as-usual arm . While this pilot trial found no statistically significant benefits for peer support on the primary or secondary outcome measures , there is an indication that hope may be further increased in those in receipt of peer support . The total cost per case for the peer support arm of the study was £ 2154 compared to £ 1922 for the control arm . The mean difference between costs was minimal and not statistically significant . However , further analyses demonstrated that peer support has a reasonably high probability of being more cost effective for a modest positive change in the measure of hopelessness . Challenges faced in recruitment and follow-up are explored alongside limitations in the delivery of peer support . Conclusions The findings suggest there is merit in conducting further research on peer support in the transition from hospital to home consideration should be applied to the nature of the patient population to whom support is offered ; the length and frequency of support provided ; and the contact between peer supporters and mental health staff . There is no conclusive evidence to support the cost effectiveness of providing peer support , but neither was it proven a costly intervention to deliver . The findings support an argument for a larger scale trial of peer support as an adjunct to existing services . Trial registration Current Controlled Trials IS RCT OBJECTIVE In spite of much effort to create guidelines on the management of violent behavior ( VB ) in emergency departments , little is known about the impact of such guidelines on a real-life emergency environment . The aim of this study is to investigate the impact of a staff educational crisis intervention ( SECI ) on the reduction of VB in patients admitted to emergency departments following drug suicidal attempt . METHOD The impact of a SECI on VB of patient consulting the ER following a drug suicide attempt was assessed by comparing the occurrence of VB before ( 5 months ) and after ( 5 months ) the introduction of a SECI . RESULTS A significant reduction in VB ( from 17.32 % to 7.14 % ) was found with the comparison of two 5-month periods : before ( 254 patients ) and after ( 224 patients ) the introduction of a SECI program ( chi(2)=11.238 ; P=.0008 ) . CONCLUSION These preliminary data suggest the need for further prospect i ve r and omized studies aim ing to prevent VB in emergency departments by developing specific SECI programs Abstract Objective To investigate whether a form of advance agreement for people with severe mental illness can reduce the use of inpatient services and compulsory admission or treatment . Design Single blind r and omised controlled trial , with r and omisation of individual patients . The investigator was blind to allocation . Setting Eight community mental health teams in southern Engl and . Participants 160 people with an operational diagnosis of psychotic illness or non-psychotic bipolar disorder who had experienced a hospital admission within the previous two years . Intervention The joint crisis plan was formulated by the patient , care coordinator , psychiatrist , and project worker and contained contact information , details of mental and physical illnesses , treatments , indicators for relapse , and advance statements of preferences for care in the event of future relapse . Main outcome measures Admission to hospital , bed days , and use of the Mental Health Act over 15 month follow up . Results Use of the Mental Health Act was significantly reduced for the intervention group , 13 % ( 10/80 ) of whom experienced compulsory admission or treatment compared with 27 % ( 21/80 ) of the control group ( risk ratio 0.48 , 95 % confidence interval 0.24 to 0.95 , P = 0.028 ) . As a consequence , the mean number of days of detention ( days spent as an inpatient while under a section of the Mental Health Act ) for the whole intervention group was 14 compared with 31 for the control group ( difference 16 , 0 to 36 , P = 0.04 ) . For those admitted under a section of the Mental Health Act , the number of days of detention was similar in the two groups ( means 114 and 117 , difference 3 , −61 to 67 , P = 0.98 ) . The intervention group had fewer admissions ( risk ratio 0.69 , 0.45 to 1.04 , P = 0.07 ) . There was no evidence for differences in bed days ( total number of days spent as an inpatient ) ( means 32 and 36 , difference 4 , −18 to 26 , P = 0.15 for the whole sample ; means 107 and 83 , difference −24 , −72 to 24 , P = 0.39 for those admitted ) . Conclusions Use of joint crisis plans reduced compulsory admissions and treatment in patients with severe mental illness . The reduction in overall admission was less . This is the first structured clinical intervention that seems to reduce compulsory admission and treatment in mental health services BACKGROUND People with borderline personality disorder frequently experience crises . To date , no r and omised controlled trials ( RCTs ) of crisis interventions for this population have been published . AIMS To examine the feasibility of recruiting and retaining adults with borderline personality disorder to a pilot RCT investigating the potential efficacy and cost-effectiveness of using a joint crisis plan . METHOD An RCT of joint crisis plans for community-dwelling adults with borderline personality disorder ( trial registration : IS RCT N12440268 ) . The primary outcome measure was the occurrence of self-harming behaviour over the 6-month period following r and omisation . Secondary outcomes included depression , anxiety , engagement and satisfaction with services , quality of life , well-being and cost-effectiveness . RESULTS In total , 88 adults out of the 133 referred were eligible and were r and omised to receive a joint crisis plan in addition to treatment as usual ( TAU ; n = 46 ) or TAU alone ( n = 42 ) . This represented approximately 75 % of our target sample size and follow-up data were collected on 73 ( 83.0 % ) participants . Intention-to-treat analysis revealed no significant differences in the proportion of participants who reported self-harming ( odds ratio ( OR ) = 1.9 , 95 % CI 0.53 - 6.5 , P = 0.33 ) or the frequency of self-harming behaviour ( rate ratio ( RR ) = 0.74 , 95 % CI 0.34 - 1.63 , P = 0.46 ) between the two groups at follow-up . No significant differences were observed between the two groups on any of the secondary outcome measures or costs . CONCLUSIONS It is feasible to recruit and retain people with borderline personality disorder to a trial of joint crisis plans and the intervention appears to have high face validity with this population . However , we found no evidence of clinical efficacy in this feasibility study BACKGROUND The CRIMSON ( CRisis plan IMpact : Subjective and Objective coercion and eNgagement ) study is
Output:
| There was evidence of benefits for liaison psychiatry teams in improving service-related outcomes in emergency departments , but this was often limited by potential confounding in most studies .
There was limited evidence regarding models to improve urgent and emergency access to crisis care to guide police officers in their Mental Health Act responsibilities .
There was positive evidence on clinical effectiveness and cost-effectiveness of crisis resolution teams but variability in implementation .
There was a large evidence base on promoting recovery with a range of interventions recommended by NICE likely to be important in helping people stay well . |
MS212981 | ***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 A commonly reported problem with the conduct of multicentre r and omised controlled trials ( RCTs ) is that recruitment is often slower or more difficult than expected , with many trials failing to reach their planned sample size within the timescale and funding originally envisaged . The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies : the UK Medical Research Council ( MRC ) and the Health Technology Assessment ( HTA ) Programme . Methods The cohort of trials was identified from the administrative data bases held by the two funding bodies . 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria . The full scientific applications and subsequent trial reports su bmi tted by the trial teams to the funders provided the principal data sources . Associations between trial characteristics and recruitment success were tested using the Chi-squared test , or Fisher 's exact test where appropriate . Results Less than a third ( 31 % ) of the trials achieved their original recruitment target and half ( 53 % ) were awarded an extension . The proportion achieving targets did not appear to improve over time . The overall start to recruitment was delayed in 47 ( 41 % ) trials and early recruitment problems were identified in 77 ( 63 % ) trials . The inter-relationship between trial features and recruitment success was complex . A variety of strategies were employed to try to increase recruitment , but their success could not be assessed . Conclusion Recruitment problems are complex and challenging . Many of the trials in the cohort experienced recruitment difficulties . Trials often required extended recruitment periods ( sometimes supported by additional funds ) . While this is of continuing concern , success in addressing the trial question may be more important than recruitment alone R and omized controlled trials ( RCTs ) in palliative cancer care often experience method ological problems . In this paper we discuss issues of major concern , including recruitment , patient attrition and compliance , arising from an RCT that compared comprehensive palliative care to conventional care . The main criteria for trial entry were incurable malignant disease and a survival expectancy of between 2 and 9 months . Patients ' health-related quality of life ( HRQL ) , self-assessed by multi-item question naires , was a defined endpoint . The planned number of patients was successfully recruited , although the patients were referred late in the course of their disease so that follow-up tended to be short . Compliance in completing HRQL question naires was good up to 1 month before the patient 's death ; but in the final weeks it was found to drop substantially . Based on our experience , recommendations are given for those planning similar research . Procedures for improving patient recruitment are suggested , stressing the need for local data management , repeated information to referral sources , extensive screening for potentially eligible patients and simple referral routines . Precise inclusion criteria , including prognostic factors other than physicians ' estimates of life expectancy , should be used to ensure a sufficient follow-up period . For HRQL assessment , multi-item question naires can achieve excellent compliance up to 1 month before patients ' death , but in order to evaluate the very final weeks of life we recommend the use of simpler methods 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 CONTEXT Latinos experience significant health disparities at the end of life compared with non-Latinos . OBJECTIVES To determine the feasibility of a patient navigator intervention to improve palliative care outcomes for Latino adults with serious illness . METHODS This was a pilot r and omized controlled trial that included 64 Latino adults with life-limiting illness r and omized to an intervention or a control group . All participants received a packet of linguistically matched material s on palliative care . In addition , intervention participants received up to five home visits from the bilingual , bicultural patient navigator . Visits focused on addressing barriers to palliative care through education , activation , and culturally tailored messaging . Outcomes included feasibility and advance care planning rates , documentation of pain management discussion s in the medical record , and hospice utilization . RESULTS Of the 32 patients r and omized to the intervention arm , 81 % had at least one home visit ( range 1 - 5 ) with the patient navigator . Overall , advance care planning was higher in the intervention group ( 47 % [ n = 15 ] vs. 25 % [ n = 8 ] , P = 0.06 ) , and 79 % of intervention participants had a discussion about pain management documented in their medical record vs. 54 % of control patients ( P = 0.05 ) . Hospice enrollment between the two groups ( n = 18 decedents ) was similar ( n = 7 intervention vs. n = 6 control ) ; length of stay in the intervention group was 36.4 ± 51.6 vs. 19.7 ± 33.6 days for control patients ( P = 0.39 ) . CONCLUSION A culturally tailored patient navigator intervention was feasible and suggests improved palliative care outcomes for Latinos facing advanced medical illness , justifying a fully powered r and omized controlled trial BACKGROUND Venous thromboembolism is common in cancer patients and requires anticoagulation with low-molecular-weight heparin ( LMWH ) . Current data recommend LMWH for anticoagulation as far as 6 months , yet guidelines recommend LMWH beyond 6 months in patients who have ongoing or active cancer . This recommendation , based on expert consensus , has not been evaluated in a clinical study . OBJECTIVES ( 1 ) To identify the most clinical ly and cost-effective length of anticoagulation with LMWH in the treatment of cancer-associated thrombosis ( CAT ) ; ( 2 ) to identify practicalities of conducting a full r and omised controlled trial ( RCT ) with regard to recruitment , retention and outcome measurement ; and ( 3 ) to explore the barriers for progressing to a full RCT . DESIGN The Anticoagulation with Low-molecular-weight heparin In the treatment of Cancer-Associated Thrombosis ( ALICAT ) trial is a r and omised , multicentre , feasibility mixed- methods study with three components : ( 1 ) a RCT comparing ongoing LMWH treatment for CAT with cessation of LMWH at 6 months ' treatment ( current licensed practice ) in patients with locally advanced or metastatic cancer , consulted in three clinical setting s ( haematology out patients , oncology out patients and primary care ) ; ( 2 ) a nested qualitative study , including focus groups with clinicians to investigate attitudes for recruiting to the study and identify the challenges of progressing to a full RCT , and semistructured interviews with patients and relatives to explore their attitudes towards participating in the study , and potential barriers and concerns to participation ; and ( 3 ) a UK-wide survey exercise to develop a classification and enumeration system for the CAT models and pathways of care . SETTING A haematology out patients department , an oncology out patients department and primary care . PARTICIPANTS Patients with ongoing active or metastatic cancer who have received 6 months of LMWH for CAT . INTERVENTIONS Ongoing LMWH treatment for CAT versus cessation of LMWH at 6 months ' treatment in patients with locally advanced or metastatic cancer . MAIN OUTCOME MEASURES ( i ) The number of eligible patients over 12 months ; ( ii ) the number of recruited patients over 12 months ( target recruitment rate of 30 % of eligible patients ) ; and ( iii ) the proportion of r and omised participants with recurrent venous thromboembolisms ( VTEs ) during follow-up . RESULTS Following several delays in setting up the RCT component of the study , 5 out of 32 eligible patients consented to be r and omised to the RCT suggesting progression to a full RCT was not feasible . Reasons for non-consenting were primarily based on a fixed preference for continuing or discontinuing treatment after 6 months of anticoagulation , and a fear of r and omisation to their non-preferred option . Views were largely influenced by patients ' initial experience of CAT . Focus groups with clinicians revealed that they would be reticent to recruit to such a study as they had fixed views of best management despite the lack of evidence . Patient pathway modelling suggested that there is a broad heterogeneity of practice with respect to CAT management and co-ordination , with no consensus on which specialty should best manage such cases . CONCLUSIONS The results of the RCT reflect recruitment from the oncology site only and provide no recruitment data from haematology centres . However , it is unlikely that these other sites would have access to more eligible patients . The management of cancer-associated thrombosis beyond 6 months will remain a clinical challenge . As it is unlikely that a prospect i ve study will successfully recruit , other strategies to accrue relevant data are necessary . Currently the LONGHEVA ( Long-term treatment for cancer patients with deep-venous thrombosis or pulmonary embolism ) registry is in development to prospect ively evaluate this important and common clinical scenario . STUDY REGISTRATION This study is registered as clinical trials.gov number NCT01817257 and International St and ard R and omised Controlled Trial Number ( IS RCT N ) 37913976 . FUNDING DETAILS Funding for the ALICAT trial was provided by the Health Technology Assessment programme ( 10/145/01 ) in response to a themed funding call . The study was design ed in accordance with the initial funding brief and feedback from the review process CONTEXT The h and held fan is an inexpensive and safe way to provide facial airflow , which may reduce the sensation of chronic refractory breathlessness , a frequently encountered symptom . OBJECTIVES To test the feasibility of developing an adequately powered , multicenter , multinational r and omized controlled trial comparing the efficacy of a h and held fan and exercise advice with advice alone in increasing activity in people with chronic refractory breathlessness from a variety of medical conditions , measuring recruitment rates ; data quality ; and potential primary outcome measures . METHODS This was a Phase II , multisite , international , parallel , nonblinded , mixed- methods r and omized controlled trial . Participants were central ly r and omized to fan or control . All received breathlessness self-management/exercise advice and were followed up weekly for four weeks . Participants /carers were invited to participate in a semistructured interview at the study 's conclusion . RESULTS Ninety-seven people were screened , 49 r and omized ( mean age 68 years ; 49 % men ) , and 43 completed the study . Site recruitment varied from 0.25 to 3.3/month and screening : r and omization from 1.1:1 to 8.5:1 . There were few missing data except for the Chronic Obstructive Pulmonary Disease Self-Efficacy Scale ( two-thirds of data missing ) . No harms were observed . Three interview themes included 1 ) a fan is a helpful self-management strategy , 2 ) a fan aids recovery , and 3 ) a symptom control trial was welcome . CONCLUSION A definitive , multisite trial to study the use of the h and held fan as part of self-management of chronic refractory breathlessness is feasible . Participants found the fan useful . However , the value of information for changing practice or policy is unlikely to justify the expense of such a trial , given perceived benefits , the minimal costs , and an absence of harms demonstrated in this study Abstract Objective : To evaluate a palliative care home support team based on an inpatient unit . Design : R and omised controlled trial with waiting list . Patients in the study group received the service immediately , those in the control group received it after one month . Main comparison point was at one month . Setting - A city of 300 000 people with a publicly funded home care service and about 200 general practitioners , most of whom provide home care . Main outcome measures : Pain and nausea levels were measured at entry to trial and at one month , as were quality of life for patients and care givers ' health . Results : Because of early deaths , problems with recruitment , and a low compliance rate for completion of question naires , the required sample size was not attained . Conclusion : In design ing evaluations of palliative care services , investigators should be prepared to deal with the following issues : attrition due to early death , opposition to r and omisation by patients and referral sources , ethical problems raised by r and omisation of dying patients , the appropriate timing of comparison points , and difficulties of collecting data from sick or exhausted patients and care givers . Investigators may choose to evaluate a service from various perspectives using different methods : controlled trials , qualitative studies , surveys , and audits . R and omised trials may prove to be impracticable for evaluation of palliative care Objective The aim of the study was to investigate how doctors considered and experienced the concept of equipoise while recruiting patients to r and omized controlled tri
Output:
| Careful messaging and the use of scripts/role play ( Promotion ) were recommended .
The need for intensive re sources and gatekeeping by professionals were barriers while having research staff on-site and lead clinician support ( Working with Partners ) was advocated .
The findings of this review are applicable to all palliative care research and not just r and omised controlled trials |
MS212982 | ***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: OBJECTIVES To evaluate a paging system design ed to improve independence in people with memory problems and executive deficits . METHODS After a successful pilot study , a r and omised control trial was conducted involving a crossover design with 143 people aged between 8 and 83 years . All had one or more of the following : memory , planning , attention , or organisation problems . Most had sustained a traumatic head injury or a stroke although a few had developmental learning difficulties or other conditions . The crossover design ensured that some people received a pager after a 2 week baseline whereas others were required to wait for 7 weeks after the baseline before receiving the pager . Participants were assessed at three time periods — namely , at baseline , 7 weeks , and at 14 weeks postbaseline . RESULTS More than 80 % of those who completed the 16 week trial were significantly more successful in carrying out everyday activities ( such as self care , self medication , and keeping appointments ) when using the pager in comparison with the baseline period . For most of these , significant improvement was maintained when they were monitored 7 weeks after returning the pager . CONCLUSIONS This particular paging system significantly reduces everyday failures of memory and planning in people with brain injury Deficits in attention and executive control are some of the most common , debilitating and persistent consequences of brain injuries . Underst and ing neural mechanisms that support clinical ly significant improvements , when they do occur , may help advance treatment development . Intervening via rehabilitation provides an opportunity to probe such mechanisms . Our objective was to identify neural mechanisms that underlie improvements in attention and executive control with rehabilitation training . We tested the hypothesis that intensive training enhances modulatory control of neural processing of perceptual information in patients with acquired brain injuries . Patients ( n=12 ) participated either in st and ardized training design ed to target goal -directed attention regulation , or a comparison condition ( brief education ) . Training result ed in significant improvements on behavioural measures of attention and executive control . Functional magnetic resonance imaging methods adapted for testing the effects of intervention for patients with varied injury pathology were used to index modulatory control of neural processing . Pattern classification was utilized to decode individual functional magnetic resonance imaging data acquired during a visual selective attention task . Results showed that modulation of neural processing in extrastriate cortex was significantly enhanced by attention regulation training . Neural changes in prefrontal cortex , a c and i date mediator for attention regulation , appeared to depend on individual baseline state . These behavioural and neural effects did not occur with the comparison condition . These results suggest that enhanced modulatory control over visual processing and a rebalancing of prefrontal functioning may underlie improvements in attention and executive control Aim : To examine the effects of working memory ( WM ) training in adult patients with stroke . Methods : A r and omized pilot study with a treatment group and a passive control group ; 18 participants ( 12 males ) in a vocational age group ( mean age 54 years ) were r and omized to either the treatment or the control condition . The intervention consisted of computerized training on various WM tasks for five weeks . A neuropsychological test battery and self-rating on cognitive functioning in daily life ( the CFQ ) were administered both before and after the treatment . Results : Statistically significant training effects were found on the non-trainedtests for WM and attention , i.e. , tests that measure related cognitive functions but are not identical to tasks in the training programme ( Span board p < 0.05 ; PASAT p < 0.001 ; Ruff 2&7 p < 0.005 ) . There was a significant decrease in symptoms of cognitive problems as measured by the CFQ ( p < 0.005 ) . Conclusion : More than one year after a stroke , systematic WM training can significantly improve WM and attention Objective : Study short- and long-term transfer effects of a computerized working memory ( WM ) training programme for patients suffering from working memory deficits after acquired brain injury . Research design : A controlled experimental study with a cross-over design . Methods : A consecutive sample of 21 subjects . Mean age 43.2 years , time since injury/illness onset 37 months ( median ) . The subjects were r and omly selected into two groups where one group served as controls . All subjects trained daily for 5 weeks in a computer WM task program . They were followed-up at 4 and 20 weeks after the training . Results : A significant improvement in the trained WM tasks , significant improvements in neuropsychological WM-test results at 4 and 20 weeks after training compared to baseline . Improvement in the subjects ’ rated occupational performance and satisfaction with performance in pre-defined occupational problems . Rated quality -of-life did not change . However , rated overall health increased 20 weeks after training . Conclusions : Structured and intense computerized WM training improves subjects ’ cognitive functioning as measured by neuropsychological WM-dem and ing tests , rated occupational performance , satisfaction with performance and rated overall health . The training probably has an impact on the rehabilitation outcome , returning to work , as well as on daily activities for individuals with verified WM impairments The aim of the study was to compare the fidelity of manualised group memory rehabilitation programmes for participants with neurological disabilities . A sample of 11 neurological patients with memory problems , enrolled in a r and omised controlled trial comparing compensation , restitution and self-help treatments , were observed during group sessions . Time-sampling was used to record the activity of the participants and the content of the discussion at one minute intervals . There was a significant difference between groups in the amount of time the group leader and participants spent talking ( p < .001 ) . Participants in the compensation and restitution groups spent significantly more time in memory rehabilitation discussion than participants in the self-help group ( p < .001 ) . There was also a significant difference between the amount of time spent discussing internal and external memory aids in the compensation and restitution groups ( p < .001 ) . These results support the fidelity of the interventions provided . This study also highlights the usefulness of time-sampling as a method to record the content and activity in rehabilitation groups Cognitive impairment is a frequent complication of stroke . The aim of this study was to evaluate the effectiveness of cognitive training performed early after stroke . Ninety-two patients were r and omly assigned to either the study group ( SG ) or the control group ( CG ) . Cognitive rehabilitation consisted of 16 individual one-hour sessions in which patients performed therapist- guided computer exercises . The patients in the CG performed a sham intervention . After four weeks all the patients were re-evaluated . In the SG , significant improvements ( p<0.05 ) were detected in all neuropsychological measures at the post-training evaluation , while the CG showed mild ( not statistically significant ) improvements on cognitive tests . Between-group analysis revealed statistically significant differences in the domains of memory and visual attention . Cognitive training performed early after stroke seems to be a viable option for improving cognitive outcome in stroke survivors . Further studies should assess whether this may favor their reintegration into everyday life BACKGROUND AND PURPOSE To be useful for clinical research , an outcome measure must be feasible to administer and have sound psychometric attributes , including reliability , validity , and sensitivity to change . This study characterizes the psychometric properties of the Stroke Impact Scale ( SIS ) Version 2.0 . METHODS Version 2.0 of the SIS is a self-report measure that includes 64 items and assesses 8 domains ( strength , h and function , ADL/IADL , mobility , communication , emotion , memory and thinking , and participation ) . Subjects with mild and moderate strokes completed the SIS at 1 month ( n=91 ) , at 3 months ( n=80 ) , and at 6 months after stroke ( n=69 ) . Twenty-five subjects had a replicate administration of the SIS 1 week after the 3-month or 6-month test . We evaluated internal consistency and test-retest reliability . The validity of the SIS domains was examined by comparing the SIS to existing stroke measures and by comparing differences in SIS scores across Rankin scale levels . The mixed model procedure was used to evaluate responsiveness of the SIS domain scores to change . RESULTS Each of the 8 domains met or approached the st and ard of 0.9 alpha-coefficient for comparing the same patients across time . The intraclass correlation coefficients for test-retest reliability of SIS domains ranged from 0.70 to 0.92 , except for the emotion domain ( 0.57 ) . When the domains were compared with established outcome measures , the correlations were moderate to strong ( 0.44 to 0.84 ) . The participation domain was most strongly associated with SF-36 social role function . SIS domain scores discriminated across 4 Rankin levels . SIS domains are responsive to change due to ongoing recovery . Responsiveness to change is affected by stroke severity and time since stroke . CONCLUSIONS This new , stroke-specific outcome measure is reliable , valid , and sensitive to change . We are optimistic about the utility of measure . More studies are required to evaluate the SIS in larger and more heterogeneous population s and to evaluate the feasibility and validity of proxy responses for the most severely impaired patients Background Stroke is one of the most common causes of cognitive impairment . Up to 75 % of stroke survivors may be considered to have cognitive impairment , which severely limit individual autonomy for successful reintegration into family , work and social life . The clinical efficacy of acupuncture with Baihui ( DU20 ) and Shenting ( DU24 ) in stroke and post-stroke cognitive impairment has been previously demonstrated . Computer-assisted cognitive training is part of conventional cognitive rehabilitation and has also shown to be effective in improvement of cognitive function of affected patients . However , the cognitive impairment after stroke is so complexity that one single treatment can not resolve effectively . Besides , the effects of acupuncture and RehaCom cognitive training have not been systematic ally compared , nor has the possibility of a synergistic effect of combination of the two therapeutic modalities been evaluated . Our primary aim of this trial is to evaluate the synergistic effect of acupuncture and RehaCom cognitive training on cognitive dysfunction after stroke . Method / Design A r and omized controlled trial of 2 × 2 factorial design will be conducted in the Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine . A total of 240 patients with cognitive dysfunction after stroke who meet the eligibility criteria will be recruited and r and omized into RehaCom training group , acupuncture group , a combination of both or control group in a 1:1:1:1 ratio . All patients will receive conventional treatment . The interventions will last for 12 weeks ( 30 min per day , Monday to Friday every week ) . Evaluations will be conducted by blinded assessors at baseline and again at 4 , 8 and 12 weeks . Outcome measurements include mini – mental state examination ( MMSE ) , Montreal cognitive assessment s ( MoCA ) , functional independence measure scale ( FIM ) and adverse events . Discussion The results of this trial are expected to clarify the synergistic effect of acupuncture and RehaCom cognitive training on cognitive dysfunction after stroke . Furthermore , to confirm whether combined or alone of acupuncture and RehaCom cognitive training , is more effective than conventional treatment in the management of post-stroke cognitive dysfunction . Trial registration Chinese Clinical Trial Registry : ChiCTR-TRC-13003704 . Registration date : 4 September , 2013 BACKGROUND Rehabilitation of impaired cognitive functions begins to be considered a st and ard component of medical care after acquired brain injury . Indeed , many evidence s support the effectiveness of the two major categories of techniques , i.e. the traditional and computer-assisted ones , which are widely used in cognitive rehabilitative treatment . OBJECTIVE Aim of this study is to evaluate the effects of pc - cognitive training in brain injury patients . METHODS We studied 35 subjects ( r and omly divided into two groups ) , affected by traumatic or vascular brain injury , having attended from January 2010 to December 2012 the Laboratory of Robotic and Cognitive Rehabilitation of IRCCS Neurolesi of Messina . Cognitive impairment was investigated through psychometric battery , administered before ( T0 ) and two months ( T1 ) after the cognitive pc-training , which was performed only by the experimental group , in addition to conventional treatment . Statistical analysis was performed using Wilcoxon test with a p < 0.01 . RESULTS At time T0 , all patients showed language deficits and cognitive alterations in visual attention and memory abilities . After the rehabilitation program we noted a global improvement in both the groups . However , at T1 , the experimental group showed a greater cognitive improvement than the control group , with significant differences in nearly all the neuropsychological tests performed . CONCLUSIONS Our data suggest that cognitive pc-training may be a promising methodology to optimize the rehabilitation outcomes following brain injury Memory problems are common in patients with a range of neurological conditions , but there have been few attempts to provide and evaluate the usefulness of memory training for groups of neurological out patients . We used a waitlist-controlled trial design to assess the effectiveness of a newly created , 6-session intervention , which involved training in the use of compensatory strategies as well as education regarding memory function , neurological damage , sleep and lifestyle factors that have an impact on memory . Fifty-six patients with neurological conditions ( e.g. , stroke , epilepsy ) and memory complaints completed the training and assessment s. Outcomes were evaluated in terms of reported strategy use as well as objective and subjective measures of antero grade and prospect i ve memory . Training result ed in significant improvements on number of strategies used , scores on the Rey Auditory Verbal Learning Test ( total learning and delayed recall ) and self-report on the Comprehensive Assessment of Prospect i ve Memory . Improvements were stable at 3-month follow-up . Better individual outcomes were related to lower baseline memory scores , fewer symptoms of depression and greater self-awareness of memory function . Overall the study provides encouraging results to indicate that patients with neurological conditions such as stroke and epilepsy can show improvements in memory after a relatively short group-based intervention Background and Purpose — Impaired attention contributes to poor stroke outcomes . Attention process training ( APT ) reduces attention deficits after traumatic brain injury . There was no evidence for effectiveness of APT in stroke
Output:
| The results do not show any significant effect of memory rehabilitation on performance in objective memory tests , mood , functional abilities , or quality of life .
AUTHORS ' CONCLUSIONS Participants who received cognitive rehabilitation for memory problems following a stroke reported benefits from the intervention on subjective measures of memory in the short term ( i.e. the first assessment point after the intervention , which was a minimum of four weeks ) .
This effect was not , however , observed in the longer term ( i.e. the second assessment point after the intervention , which was a minimum of three months ) .
There was , therefore , limited evidence to support or refute the effectiveness of memory rehabilitation . |
MS212983 | ***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 In the HPV FOCAL trial , we will establish the efficacy of hr-HPV DNA testing as a st and -alone screening test followed by liquid based cytology ( LBC ) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome . Methods / Design HPV-FOCAL is a r and omized , controlled , three-armed study over a four year period conducted in British Columbia . It will recruit 33,000 women aged 25 - 65 through the province 's population based cervical cancer screening program . Control arm : LBC at entry and two years , and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases ; Two Year Safety Check arm : hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives ; Four Year Intervention Arm : hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion To date , 6150 participants have a completed sample and epidemiologic question naire . Of the 2019 women enrolled in the control arm , 1908 ( 94.5 % ) were cytology negative . Women aged 25 - 29 had the highest rates of HSIL ( 1.4 % ) . In the safety arm 92.2 % of women were hr-HPV negative , with the highest rate of hr-HPV positivity found in 25 - 29 year old women ( 23.5 % ) . Similar results were obtained in the intervention arm HPV FOCAL is the first r and omized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population -based cervical cancer screening program . Trial Registration International St and ard R and omised Controlled Trial Number Register , IS RCT BACKGROUND To determine whether testing for DNA of oncogenic human papillomaviruses ( HPV ) is superior to the Papanicolaou ( Pap ) test for cervical-cancer screening , we conducted a r and omized trial comparing the two methods . METHODS We compared HPV testing , using an assay approved by the Food and Drug Administration , with conventional Pap testing as a screening method to identify high- grade cervical intraepithelial neoplasia in women ages 30 to 69 years in Montreal and St. John 's , Canada . Women with abnormal Pap test results or a positive HPV test ( at least 1 pg of high-risk HPV DNA per milliliter ) underwent colposcopy and biopsy , as did a r and om sample of women with negative tests . Sensitivity and specificity estimates were corrected for verification bias . RESULTS A total of 10,154 women were r and omly assigned to testing . Both tests were performed on all women in a r and omly assigned sequence at the same session . The sensitivity of HPV testing for cervical intraepithelial neoplasia of grade 2 or 3 was 94.6 % ( 95 % confidence interval [ CI ] , 84.2 to 100 ) , whereas the sensitivity of Pap testing was 55.4 % ( 95 % CI , 33.6 to 77.2 ; P=0.01 ) . The specificity was 94.1 % ( 95 % CI , 93.4 to 94.8 ) for HPV testing and 96.8 % ( 95 % CI , 96.3 to 97.3 ; P<0.001 ) for Pap testing . Performance was unaffected by the sequence of the tests . The sensitivity of both tests used together was 100 % , and the specificity was 92.5 % . Triage procedures for Pap or HPV testing result ed in fewer referrals for colposcopy than did either test alone but were less sensitive . No adverse events were reported . CONCLUSIONS As compared with Pap testing , HPV testing has greater sensitivity for the detection of cervical intraepithelial neoplasia . ( Current Controlled Trials number , IS RCT N57612064 [ controlled-trials.com ] . ) BACKGROUND Although testing for human papillomavirus ( HPV ) has higher sensitivity and lower specificity than cytology alone for detecting cervical intraepithelial neoplasia ( CIN ) , studies comparing conventional and liquid-based cytology have had conflicting results . METHODS In the first phase of a two-phase multicenter r and omized controlled trial , women aged 35 - 60 years in the conventional arm ( n = 16,658 ) were screened using conventional cytology , and women in the experimental arm ( n = 16,706 ) had liquid-based cytology and were tested for high-risk HPV types using the Hybrid Capture 2 assay . Women in the conventional arm were referred to colposcopy with atypical cells of undetermined significance ( ASCUS ) or higher and those in the experimental arm were referred with ASCUS or higher cytology or with a positive ( > or = 1 pg/mL ) HPV test . Sensitivity and positive predictive value ( PPV ) for detection of cervical intraepithelial neoplasia grade 2 or higher ( CIN2 + ) were calculated . RESULTS The screening methods and referral criterion applied in the experimental arm had higher sensitivity than that in the conventional arm ( relative sensitivity = 1.47 ; 95 % confidence interval [ CI ] = 1.03 to 2.09 ) but a lower PPV ( relative PPV = 0.40 ; 95 % CI = 0.23 to 0.66 ) . With HPV testing alone at > or = 1 pg/mL and at > or = 2 pg/mL , the gain in sensitivity compared with the conventional arm remained similar ( relative sensitivity = 1.43 , 95 % CI = 1.00 to 2.04 and relative sensitivity = 1.41 , 95 % CI = 0.98 to 2.01 , respectively ) but PPV progressively improved ( relative PPV = 0.58 , 95 % CI = 0.33 to 0.98 and relative PPV = 0.75 , 95 % CI = 0.45 and 1.27 , respectively ) . Referral based on liquid-based cytology alone did not increase sensitivity compared with conventional cytology ( relative sensitivity = 1.06 ; 95 % CI = 0.72 to 1.55 ) but reduced PPV ( relative PPV = 0.57 ; 95 % CI = 0.39 to 0.82 ) . CONCLUSIONS HPV testing alone was more sensitive than conventional cytology among women 35 - 60 years old . Adding liquid-based cytology improved sensitivity only marginally but increased false-positives . HPV testing using Hybrid Capture 2 with a 2 pg/mL cutoff may be more appropriate than a 1 pg/mL cutoff for primary cervical cancer screening BACKGROUND Primary cervical screening with both human papillomavirus ( HPV ) DNA testing and cytological examination of cervical cells with a Pap test ( cytology ) has been evaluated in r and omized clinical trials . Because the vast majority of women with positive cytology are also HPV DNA positive , screening strategies that use HPV DNA testing as the primary screening test may be more effective . METHODS We used the data base from the intervention arm ( n = 6,257 women ) of a population -based r and omized trial of double screening with cytology and HPV DNA testing to evaluate the efficacy of 11 possible cervical screening strategies that are based on HPV DNA testing alone , cytology alone , and HPV DNA testing combined with cytology among women aged 32 - 38 years . The main outcome measures were sensitivity for detection of cervical intraepithelial neoplasia grade 3 or worse ( CIN3 + ) within 6 months of enrollment or at colposcopy for women with a persistent type-specific HPV infection and the number of screening tests and positive predictive value ( PPV ) for each screening strategy . All statistical tests were two-sided . RESULTS Compared with screening by cytology alone , double testing with cytology and for type-specific HPV persistence result ed in a 35 % ( 95 % confidence interval [ CI ] = 15 % to 60 % ) increase in sensitivity to detect CIN3 + , without a statistically significant reduction in the PPV ( relative PPV = 0.76 , 95 % CI = 0.52 to 1.10 ) , but with more than twice as many screening tests needed . Several strategies that incorporated screening for high-risk HPV subtypes were explored , but they result ed in reduced PPV compared with cytology . Compared with cytology , primary screening with HPV DNA testing followed by cytological triage and repeat HPV DNA testing of HPV DNA-positive women with normal cytology increased the CIN3 + sensitivity by 30 % ( 95 % CI = 9 % to 54 % ) , maintained a high PPV ( relative PPV = 0.87 , 95 % CI = 0.60 to 1.26 ) , and result ed in a mere 12 % increase in the number of screening tests ( from 6,257 to 7,019 tests ) . CONCLUSIONS Primary HPV DNA-based screening with cytology triage and repeat HPV DNA testing of cytology-negative women appears to be the most feasible cervical screening strategy Objective To assess which of three triage strategies for women with borderline abnormal cervical smear results in the best psychosocial outcomes . Design Pragmatic , non-blinded , multicentre , r and omised controlled trial . Setting 18 family planning clinics across Australia , covering both urban and rural areas , between January 2004 and October 2006 . Participants Women aged 16 - 70 years ( n=314 ) who attended routine cervical screening and received a borderline cervical smear . Interventions Patients were r and omly assigned to human papillomavirus ( HPV ) DNA testing ( n=104 ) , a repeat smear test at six months ( n=106 ) , or the patient ’s informed choice of either test supported by a decision aid ( n=104 ) . Psychosocial outcomes were assessed at multiple time points over 12 months by postal question naire . Main outcome measures We assessed health related quality of life ( SF36 mental health subscale ) , cognitive effects ( such as perceived risk of cervical cancer , intrusive thoughts ) , affective outcomes ( general anxiety [ state-trait anxiety inventory ] ) , specific anxiety about an abnormal smear ( cervical screening question naire ) , and behavioural outcomes ( sexual health behaviour and visits to the doctor ) over 12 months of follow-up . Results At two weeks , some psychosocial outcomes were worse for women allocated to HPV testing compared with those in the smear testing group ( SF36 vitality subscale : t=−1.63 , df=131 , P=0.10 ; intrusive thoughts χ2=8.14 , df=1 , P<0.01 ) . Over 12 months , distress about the abnormal smear was lowest in women allocated to HPV testing and highest in the repeat smear testing group ( t=−2.89 , df=135 , P<0.01 ) . Intrusive thoughts were highest in patients allocated to HPV testing ( 25 % , compared with 13 % in the informed choice group ; difference=12 % , 95 % CI −1.1 % to 25.1 % ) . Women in the HPV DNA group and the informed choice group were more satisfied with their care than women allocated to repeat smear testing . Conclusions Although the psychosocial effect was initially worse for women allocated to HPV triage , over the full year of follow-up this intervention was better for women ’s psychosocial health than repeat smear testing . Offering informed choice could have a small advantage for cognitive outcomes , but in view of the additional effort and logistical complexity that this intervention requires , HPV testing alone can be justified for most women . Trial Registration actr.org.au Identifier : BACKGROUND Testing for human papillomavirus ( HPV ) DNA is reportedly more sensitive than cytology for the detection of high- grade cervical intraepithelial neoplasia ( CIN ) . The effectiveness of HPV testing in primary cervical screening was assessed in the ARTISTIC trial , which was done over two screening rounds approximately 3 years apart ( 2001 - 03 and 2004 - 07 ) by comparing liquid-based cytology ( LBC ) combined with HPV testing against LBC alone . METHODS Women aged 20 - 64 years who were undergoing routine screening as part of the English National Health Service Cervical Screening Programme in Greater Manchester were r and omly assigned ( between July , 2001 , and September , 2003 ) in a ratio of 3:1 to either combined LBC and HPV testing in which the results were revealed and acted on , or to combined LBC and HPV testing where the HPV result was concealed from the patient and investigator . The primary outcome was the detection rate of cervical intraepithelial neoplasia grade 3 or worse ( CIN3 + ) in the second screening round , analysed by intention to treat . This trial is registered with the International St and ard R and omised Controlled Trial Number IS RCT N25417821 . FINDINGS There were 24 510 eligible women at entry ( 18 386 in the revealed group , 6124 in the concealed group ) . In the first round of screening 233 women ( 1.27 % ) in the revealed
Output:
| Four fair- to good- quality diagnostic accuracy studies and 4 fair- to good- quality RCTs showed mixed results of cotesting ( HPV plus cytology ) in women aged 30 years or older compared with cytology alone , with no clear advantage over primary HPV screening . |
MS212984 | ***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 prospect ively evaluate the psychosocial outcomes and body image of patients 2 years postmastectomy reconstruction using a multicenter , multisurgeon approach . Background : Although breast reconstruction has been shown to confer significant psychosocial benefits in breast cancer patients at year 1 postreconstruction , we considered the possibility that psychosocial outcomes may remain in a state of flux for years after surgery . Methods : Patients were recruited as part of the Michigan Breast Reconstruction Outcome Study , a 12 center , 23 surgeon prospect i ve cohort study of mastectomy reconstruction patients . Two-sided paired sample t tests were used to compare change scores for the various psychosocial subscales . Multiple regression analysis was used to determine whether the magnitude of the change score varied by procedure type . Results : Preoperative and postoperative year 2 surveys were received from 173 patients ; 116 with immediate and 57 with delayed reconstruction . For the immediate reconstruction cohort , significant improvements were observed in all psychosocial subscales except for body image . This occurred essentially independent of procedure type . In the cohort with delayed reconstruction , significant change scores were observed only in body image . Women with transverse rectus abdominis musculocutaneous flaps had significantly greater gains in body image scores ( P = 0.003 and P = 0.034 , respectively ) when compared with exp and er/implants . Conclusions : General psychosocial benefits and body image gains continued to manifest at 2 years postmastectomy reconstruction . In addition , procedure type had a surprisingly limited effect on psychosocial well being . With outcomes evolving beyond year 1 , these data support the need for additional longitudinal breast reconstruction outcome studies Although it is thought that transverse rectus abdominis muscle ( TRAM ) flap breast reconstruction produces excellent cosmetic results that are maintained over the long term , there is little objective evidence in the literature to support this . One hundred seventy‐one consecutive patients who underwent TRAM flap reconstruction were prospect ively analyzed over an 8‐year period to assess their morbidity and late cosmetic outcome . The early patient complication rate ( < 2 months ) was 37.4 percent , the late hernia and fat necrosis rates ( > 2 months ) were 8.8 and 13.5 percent , respectively , and the contralateral symmetrization rate was 33.9 percent . The cosmetic results were evaluated prospect ively using an objective five‐point global scale . Each patient was scored at each visit once surgery was completed . Follow‐up continued until a flap was lost , a patient died , or the point of last patient contact was reached . Six patients died during the study . The actuarial percentage cosmetic outcome remained stable during the study period , with an acceptable result in 96.4 percent of patients at 2 years and in 94.2 percent of patients at 5 years . Only five patients in this series obtained poor cosmetic outcomes , with three due to substantial flap necrosis and two because of poor flap design . Two free TRAM flaps were also lost . Log‐rank analysis revealed that neither patient age nor timing of surgery significantly affected the cosmetic outcome . Single pedicle and supercharged ( single pedicle ) TRAM flaps produced slightly better results than bipedicle and free TRAM flaps . In this prospect i ve longitudinal study , TRAM flap reconstructions were shown to produce aesthetically pleasing results . Moreover , with long‐term follow‐up , it was demonstrated that these reconstructions maintained their stability . ( Plast . Reconstr . Surg . 107 : 1710 , 2001 . In the past decade , changing attitudes toward breast reconstruction among both patients and providers have led a growing number of women to seek breast reconstruction after mastectomy . Although investigators have documented the psychological , social , emotional , and functional benefits of breast reconstruction , little research has evaluated the effects of procedure choice on these outcomes . The current study prospect ively evaluated and compared psychosocial outcomes for three common options for mastectomy reconstruction : tissue exp and er/implant , pedicle TRAM , and free TRAM techniques . In a prospect i ve cohort design , patients undergoing postmastectomy reconstruction for the first time with exp and er/implant , pedicle TRAM , or free TRAM procedures were recruited from 12 centers and 23 plastic surgeons in the United States and Canada . Before reconstruction and at 1 year after reconstruction , patients were evaluated by a battery of question naires consisting of both generic and condition-specific surveys . Outcomes assessed included emotional well-being , vitality , general mental health , social functioning , functional well-being , social well-being , and body image . Baseline ( preoperative ) scores and the change in scores ( the difference between postoperative and preoperative scores ) were compared across procedure types using t tests and analysis of covariance . Preoperative and 1-year postoperative surveys were obtained from 273 patients . Procedure type was reported in 250 patients , of whom 56 received implant reconstructions , 128 pedicle TRAM flaps , and 66 free TRAM flaps . A total of 161 immediate and 89 delayed reconstructions were performed . Among women receiving immediate reconstruction , significant improvements were observed in all psychosocial variables except body image . However , no significant effects of procedure type on these changes over time existed . Similarly , delayed reconstruction patients had significant increases in emotional well-being , vitality , general mental health , functional well-being , and body image . Although the choice of reconstructive technique did not significantly impact most of these outcomes , significant differences existed among procedure types for three psychosocial subscales . Patients undergoing delayed exp and er/implant reconstructions reported greater improvements in vitality and social well-being relative to women receiving delayed TRAM procedures . By contrast , delayed TRAM patients noted significantly greater gains in body image compared with women choosing delayed exp and er-implant reconstruction . The authors conclude that both immediate and delayed breast reconstructions provide substantial psychosocial benefits for mastectomy patients . Although the choice of reconstructive procedure does not seem to significantly affect improvements in psychosocial status with immediate reconstruction , our data suggest that procedure type does have a significant effect on gains in vitality and body image for women undergoing delayed reconstruction BACKGROUND Previously , we found patient satisfaction with breast reconstruction at postoperative year 1 significantly higher in the autogenous tissue compared with the exp and er/implant population . But breast reconstructive procedures have different " aging " processes , and the point at which outcomes stabilize is unclear . So we evaluated patient satisfaction with breast reconstruction at postoperative year 2 and compared the results with those from our previous study . STUDY DESIGN As part of the Michigan Breast Reconstruction Outcomes Study , women undergoing mastectomy reconstruction ( including exp and er/implants and pedicle and free transverse rectus abdominis musculocutaneous flaps [ TRAM ] ) were prospect ively evaluated . Preoperatively and at postoperative years 1 and 2 , women completed a question naire that collected a variety of vali date d health status information . The postoperative question naire had an additional seven items assessing both general and esthetic satisfaction as separate subscales . To assess the effects of procedure on satisfaction and control for possible confounding , multiple logistic regression was used . RESULTS At year 2 , patients with TRAM flaps ( both free and pedicle ) continued to have higher levels of esthetic satisfaction compared with exp and er/implant patients ( odds ratio 2.8 , p < 0.01 ) . But no significant differences were appreciated in esthetic satisfaction between women with free and pedicle TRAM flaps . In regard to general satisfaction , the type of reconstruction ( exp and er/implant , pedicle TRAM , and free TRAM ) had no statistically significant effect . CONCLUSIONS At postoperative year 2 , procedural differences initially found in women 's general satisfaction with breast reconstruction diminish . Specifically , women with pedicle TRAM flaps , free TRAM flaps , and exp and er/implants had similar levels of general satisfaction . But at year 2 , patients continue to be more esthetically satisfied with autogenous tissue than with exp and er/implant reconstructions Twenty-seven free transverse rectus abdominis musculocutaneous ( TRAM ) and 16 pedicled TRAM flap breast reconstruction patients were studied for 7 to 41 months ( mean , 23 months ) postoperatively to compare abdominal sequelae after these two operations . The patient groups were demographically similar ; mean age was 47 years in both groups . Subjective grading of the results was similar in both groups . The incidence of minor lower abdominal bulges was higher ( 44 % , 7/16 ) in the pedicled group than in the free TRAM flap group ( 4 % , 1/27 ) . No hernias were found . Delayed healing of the abdominal scar occurred in 3 free TRAM flap and 1 pedicled TRAM flap patients . Two free TRAM flap ( 8 % ) and 7 pedicled TRAM ( 44 % ) flap patients had minor edge necrosis of the breast . Trunk strength was tested using an isokinetic device ( Lido Multi Joint II ) , and peak torque for flexion ( mean , 111 Nm ± 25 Nm in the free TRAM flap group and 123 Nm ± 28 Nm in the pedicled TRAM flap group ) and extension ( mean , 144 Nm ± 38 Nm and 167 Nm ± 45 Nm ) were measured . No statistical differences occurred between these groups . Sit-up performance was tested and grade d from 1 to 6 . Both groups performed equally ( 4.8 and 4.8 ) and within normal values for this age group . Ultrasonography of the rectus muscles revealed that in the free TRAM flap group , the rectus muscle of the operated side was significantly thinner ( cranial segment 6.8 mm vs. 7.8 mm , p < 0.05 ) , thus the harvesting of a segment of muscle below the umbilicus seems to disturb the quality of the entire muscle . The mean size of the muscular defect in the free TRAM flap group was 4.3 x 6.1 cm . In this study no differences in patient satisfaction or trunk strength could be found between free and pedicled TRAM flap patients Background : Functional outcomes in breast reconstruction are important quality measures and aid in patients ' decision-making process . To address the concerns of abdominal wall morbidity with transverse rectus abdominis musculocutaneous ( TRAM ) flap reconstructions , the authors prospect ively evaluated the long-term effects of postmastectomy breast reconstruction on trunk function using objective clinical measures . Methods : Using a multicenter prospect i ve cohort design , they recruited women undergoing first-time immediate or delayed breast reconstructions from 12 centers and 23 plastic surgeons . Trunk functional data , objective ly measured with Cybex machines , for patients with an exp and er/implant , pedicle TRAM , and free TRAM reconstructions were evaluated preoperatively and at postoperative years 1 and 2 in 183 patients . The effects of procedure type , timing , and laterality on trunk peak torque and range of motion were analyzed using linear regression . Results : At 2 years postoperatively , procedure type , timing , and laterality did not significantly affect the range of motion for trunk flexion and extension . Peak torque for trunk flexion at year 2 was significantly decreased in patients with TRAM compared with exp and er/implant reconstructions ( p < 0.05 ) , with a 6 to 19 percent decrease in flexion peak torque . However , no significant difference in flexion peak torque was found between patients with free and pedicle TRAM reconstructions . Conclusions : The authors found that ( 1 ) breast cancer patients with TRAM reconstructions had a less than 20 percent long-term deficit in trunk flexion peak torque and ( 2 ) there was no significant difference in trunk function between patients receiving pedicle and free TRAM reconstructions Objective The authors prospect ively studied the impact of immediate breast reconstruction on patients undergoing mastectomy . Summary Background Data Despite the advocation of a breast-conserving approach to the treatment of breast cancer , many women continue to medically require or choose mastectomy for the treatment of breast cancer . In recent years , immediate breast reconstruction has become an alternative to either mastectomy alone or to delayed reconstruction . Methods A prospect i ve data base of 216 patients who underwent mastectomy with immediate reconstruction was established . In this series , 94 procedures involved implants or tissue exp and ers , and 124 tissue transfers were performed . Results The overall complication rate was 15.3 % ; only 9 % of patients who underwent autologous tissue transfers required secondary procedures . When implants were performed , the overall rate of prosthetic loss was 8 % . The majority of patients ( n = 101 ) underwent transverse rectus abdominis musculocutaneous ( TRAM ) flaps . Twenty-six of the 38 ( 17.5 % ) patients who required transfusion were from this group . Partial flap losses in this group ( 7 % ) were correlated to a history of heavy smoking . With a median follow-up of 33.2 months , only two patients had recurred locally . According to patient opinion , autologous tissue transfers result ed in a statistically better cosmetic result . Conclusions Immediate reconstruction can be performed safely and with excellent cosmetic results Abdominal weakness is a known potential complication of breast reconstruction with a pedicled or free TRAM flap . It has been presumed that the DIEP flap , which involves no muscle resection , does not compromise abdominal muscle strength but little objective research exists to substantiate this . The aims of this retrospective study were to compare abdominal muscle strength following free TRAM flap and DIEP flap , to compare both groups with a control group and to establish the effect of both procedures on functional activities . Fifty women ( 23 with a DIEP flap , 27 with a free TRAM flap ) plus 32 non-operated controls underwent assessment of their abdominal and back extensor muscle strength on a KIN COM isokinetic dynamometer . Two question naires were used to establish the impact on function . The TRAM flap group had significant weakness of the abdominal and back extensor muscles compared with the DIEP flap group and the control group . The trend was for the DIEP flap group to
Output:
| However , none of the comparative studies of pedicle and free TRAM procedures found significant differences in abdominal wall function between the 2 groups .
Free TRAM groups experienced minimal deficit in rectus muscle function , whereas DIEP flaps returned to baseline for both rectus and oblique muscle function .
Subjective measures of abdominal wall function were similar across unipedicle TRAM , free TRAM , and DIEP flap procedures .
Patients with bilateral pedicle or free TRAM reconstruction also experienced a significant decrease in the ability to perform sit-ups and a significant decrease in activities of daily living , recreational , and laborious activities .
With the exception of those who had bipedicled TRAM or bilateral free TRAM procedures , most women reported return to their preoperative function without a decrease in their ability to perform activities of daily living .
Although some studies report an objective advantage of DIEP flaps , this does not appear to translate to detriments in the performance of activities of daily living . |
MS212985 | ***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 Patients with chronic heart failure ( CHF ) have a continuing high mortality . Autonomic dysfunction may play an important role in the pathophysiology of cardiac death in CHF . UK-HEART examined the value of heart rate variability ( HRV ) measures as independent predictors of death in CHF . METHODS AND RESULTS In a prospect i ve study powered for mortality , we recruited 433 out patients 62+/-9.6 years old with CHF ( NYHA functional class I to III ; mean ejection fraction , 0.41+/-0.17 ) . Time-domain HRV indices and conventional prognostic indicators were related to death by multivariate analysis . During 482+/-161 days of follow-up , cardiothoracic ratio , SDNN , left ventricular end-systolic diameter , and serum sodium were significant predictors of all-cause mortality . The risk ratio for a 41.2-ms decrease in SDNN was 1.62 ( 95 % CI , 1.16 to 2.44 ) . The annual mortality rate for the study population in SDNN subgroups was 5.5 % for > 100 ms , 12.7 % for 50 to 100 ms , and 51.4 % for < 50 ms . SDNN , creatinine , and serum sodium were related to progressive heart failure death . Cardiothoracic ratio , left ventricular end-diastolic diameter , the presence of nonsustained ventricular tachycardia , and serum potassium were related to sudden cardiac death . A reduction in SDNN was the most powerful predictor of the risk of death due to progressive heart failure . CONCLUSIONS CHF is associated with autonomic dysfunction , which can be quantified by measuring HRV . A reduction in SDNN identifies patients at high risk of death and is a better predictor of death due to progressive heart failure than other conventional clinical measurements . High-risk subgroups identified by this measurement are c and i date s for additional therapy after prescription of an ACE inhibitor Background Functional limitations , altered cardiac autonomic activity , and psychological distress are known disorders in chronic hemodialysis ( HD ) patients , relating to increased morbidity and mortality . The aim of this study was to examine the influence of an exercise training program on emotional parameters and heart rate variability ( HRV ) indices , as well as to determine whether emotional stress contributes to autonomic dysfunction in these patients . Methods Forty-four HD patients were r and omly assigned into group A ( 24 patients , aged 46.3 ± 11.2 years ) , who participated in a 1-year intradialytic exercise training program and group B ( 20 patients , aged 45.8 ± 10.8 years ) , who were used as controls . At baseline and a year after , measures of HRV were obtained for the estimation of st and ard deviation of RR intervals , the mean square successive differences , percentage of RR intervals differing by more than 50 ms from the preceding RR interval ( pNN50 ) , and low to high frequency components . Emotional parameters ( Beck Depression Inventory – BDI and Hospital Anxiety and Depression Scale – HADS ) were also assessed by vali date d question naires . Moreover , all patients performed a spiroergometric study for the estimation of VO2peak . Results At baseline , all measurements were similar in the two groups and remained almost unchanged after a year in group B. After a year of training , VO2peak increased from 16.79 ± 5.24 to 22.33 ± 4.90 ml/kg per min ( P > 0.001 ) in group A. Trained patients also showed an increase in st and ard deviation of RR intervals by 58.8 % ( P > 0.001 ) , the mean square successive differences by 68.1 % ( P > 0.001 ) , pNN50 by 23.5 % ( P > 0.001 ) , and a low to high frequency ratio by 17.3 % ( P > 0.001 ) . Finally , at the end of the study , group A showed a decrease in BDI score by 34.5 % ( P > 0.001 ) and HADS by 23.9 % ( P > 0.001 ) . Canonical correlation revealed significant inverse correlation among depression ( in BDI and HADS ) and HRV indices before and after exercise training . Conclusion Cardiac autonomic modulation seemed to be sensitive to the experience of persistent depression in HD patients . Significantly , exercise training reduced emotional distress and concomitantly improved HRV AIM To evaluate the effects of a yoga-based exercise program on pain , fatigue , sleep disturbance , and biochemical markers in hemodialysis patients . MATERIAL S AND METHODS In 2004 a r and omized controlled trial was carried out in the outpatient hemodialysis unit of the Nephrology Department , Uludag University Faculty of Medicine . Clinical ly stable hemodialysis patients ( n=37 ) were included and followed in two groups : the modified yoga-based exercise group ( n=19 ) and the control group ( n=18 ) . Yoga-based exercises were done in groups for 30 min/day twice a week for 3 months . All of the patients in the yoga and control groups were given an active range of motion exercises to do for 10 min at home . The main outcome measures were pain intensity ( measured by the visual analogue scale , VAS ) , fatigue ( VAS ) , sleep disturbance ( VAS ) , and grip strength ( mmHg ) ; biochemical variables-- urea , creatinine , calcium , alkaline phosphatase , phosphorus , cholesterol , HDL-cholesterol , triglyceride , erythrocyte , hematocrit -- were evaluated . RESULTS After a 12-week intervention , significant improvements were seen in the variables : pain -37 % , fatigue -55 % , sleep disturbance -25 % , grip strength + 15 % , urea -29 % , creatinine -14 % , alkaline phosphatase -15 % , cholesterol -15 % , erythrocyte + 11 % , and hematocrit count + 13 % ; no side-effects were seen . Improvement of the variables in the yoga-based exercise program was found to be superior to that in the control group for all the variables except calcium , phosphorus , HDL-cholesterol and triglyceride levels . CONCLUSION A simplified yoga-based rehabilitation program is a complementary , safe and effective clinical treatment modality in patients with end-stage renal disease BACKGROUND The prevalence of obesity has markedly increased in patients with chronic kidney disease ( CKD ) . Studies on the impact of exercise focusing on obese CKD patients are scarce . Therefore , we aim ed to investigate the effect of aerobic exercise performed either in an exercise centre or at home on visceral fat in overweight non-dialysed CKD patients . METHODS Twenty-seven sedentary men ( 52.1 ± 9.5 years , body mass index 30.4 ± 3.8 kg/m(2 ) , estimated glomerular filtration rate ( eGFR ) 27.5 ± 11.6 mL/min ) were r and omly assigned to a centre-based exercise group ( n = 10 ) , home-based exercise group ( n = 8) or control group ( n = 9 ) . The aerobic training was prescribed according to ventilatory threshold and performed three times per week during 12 weeks . Body composition was assessed by dual energy X-ray absorptiometry ( DEXA ) and the distribution of abdominal fat by computed tomography . RESULTS In the centre-based group , visceral fat and waist circumference decreased 6.4 ± 6.4 mm ( P < 0.01 ) and 2.0 ± 2.3 cm ( P = 0.03 ) and leg lean mass increased 0.5 ± 0.4 kg ( P < 0.01 ) . No significant changes were observed in the home-based group . Visceral fat increased 5.0 ± 4.4 mm in the control group ( P = 0.01 ) . In relation to the control , a group-by-time interaction was significant for visceral fat and waist circumference for both exercise groups and for leg lean mass for the centre-based group . Mean blood pressure decreased in both exercise groups ( centre-based 13 % , P < 0.01 and home-based 10 % , P = 0.03 ) and eGFR increased 3.6 ± 4.6 mL/min ( P = 0.03 ) in the centre-based group . These parameters remained unchanged in the control group . CONCLUSIONS Centre-based aerobic exercise is an effective approach to reduce visceral fat besides promoting relevant clinical benefits in male overweight CKD patients BACKGROUND AND OBJECTIVES CKD is associated with poor cardiorespiratory fitness ( CRF ) . This predefined sub study determined the effect of exercise training and lifestyle intervention on CRF and explored the effect on cardiovascular risk factors and cardiac and vascular function . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS Between February 2008 and March 2010 , 90 patients with stage 3 - 4 CKD were screened with an exercise stress echocardiogram before enrollment . Patients ( n=83 ) were r and omized to st and ard care ( control ) or lifestyle intervention . The lifestyle intervention included multidisciplinary care ( CKD clinic ) , a lifestyle program , and aerobic and resistance exercise training for 12 months . CRF ( peak Vo2 ) , left ventricular function , arterial stiffness , anthropometric , and biochemical data were collected at baseline and 12 months . RESULTS Ten percent of r and omized patients had sub clinical myocardial ischemia at screening and completed the study without incident . There was no baseline difference among 72 patients who completed follow-up ( 36 in the lifestyle intervention group and 36 in the control group ) . The intervention increased peak Vo2 ( 2.8±0.7 ml/kg per minute versus -0.3±0.9 ml/kg per minute ; P=0.004 ) . There was small weight loss ( -1.8±4.2 kg versus 0.7±3.7 kg ; P=0.02 ) but no change in BP or lipids . Diastolic function improved ( increased e ' of 0.75±1.16 cm/s versus -0.47±1.0 cm/s ; P=0.001 ) but systolic function was well preserved and did not change . The change in arterial elastance was attenuated ( 0.11±0.76 mmHg/ml versus 0.76±0.96 mmHg/ml ; P=0.01 ) . Δ peak Vo2 was associated with group allocation and improved body composition . CONCLUSIONS Exercise training and lifestyle intervention in patients with CKD produces improvements in CRF , body composition , and diastolic function Background : Dyslipidemia has been established as a well-known traditional risk factor for cardiovascular disease in chronic kidney disease patients . Aim : This study investigated the impact of Hatha yoga exercise on lipid parameters in patients with end-stage renal disease ( ESRD ) on hemodialysis . Material s and Methods : This prospect i ve r and omized study consisted of 33 ESRD patients in the Hatha yoga exercise group that was matched with 35 ESRD patients in the control group . Serum total cholesterol , triglycerides , low-density lipoprotein (LDL)-cholesterol , and high-density lipoprotein (HDL)-cholesterol were determined at baseline ( 0 month ) and after 4 months . Results : Comparing values after 4 months versus baseline in the prehemodialysis Hatha yoga exercise group , there was found a significant decrease in total cholesterol from 5.126 ± 0.092 mmol/l to 4.891 ± 0.072 mmol/l ( -4.58 % ; P = 0.0001 ) , triglycerides from 2.699 ± 0.078 mmol/l to 2.530 ± 0.063 mmol/l ( -6.26 % ; P = 0.0001 ) , LDL-cholesterol from 2.729 ± 0.083 mmol/l to 2.420 ± 0.066 mmol/l ( -11.32 % ; P = 0.0001 ) , and total cholesterol/HDL-cholesterol ratio from 5.593 ± 0.119 mmol/l to 4.907 ± 0.116 mmol/l ( -12.26 % ; P = 0.047 ) . For patients in the Hatha yoga exercise group , 51.5 % had normal total cholesterol at 0 month while 70.0 % had normal total cholesterol ( P < 0.05 ) after 4 four months and 54.5 % of patients had normal LDL-cholesterol at 0 month while 84.9 % had normal LDL-cholesterol after 4 months ( P < 0.05 ) . Conclusion : These findings suggest that Hatha yoga exercise has preventive and beneficial effects and may be a safe therapeutic modality in ESRD patients BACKGROUND Cardiovascular disease ( CVD ) mortality rates are greatly elevated in chronic kidney disease patients receiving maintenance haemodialysis therapy . The purpose of this study was to evaluate the efficacy of intradialytic endurance exercise training on novel risk
Output:
| The strongest evidence is for the effects of aerobic exercise on improving physical fitness , muscular strength and quality of life in dialysis patients .
The benefits of exercise in dialysis patients are well established , supporting the prescription of physical activity in their regular treatment . |
MS212986 | ***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: BACKGROUND Between 1995 and 2000 , KwaZulu-Natal province , South Africa , experienced a marked increase in Plasmodium falciparum malaria , fuelled by pyrethroid and sulfadoxine-pyrimethamine resistance . In response , vector control was strengthened and artemether-lumefantrine ( AL ) was deployed in the first Ministry of Health artemisinin-based combination treatment policy in Africa . In South Africa , effective vector and parasite control had historically ensured low-intensity malaria transmission . Malaria is diagnosed definitively and treatment is provided free of charge in reasonably accessible public-sector health-care facilities . METHODS AND FINDINGS We review ed four years of malaria morbidity and mortality data at four sentinel health-care facilities within KwaZulu-Natal 's malaria-endemic area . In the year following improved vector control and implementation of AL treatment , malaria-related admissions and deaths both declined by 89 % , and outpatient visits decreased by 85 % at the sentinel facilities . By 2003 , malaria-related outpatient cases and admissions had fallen by 99 % , and malaria-related deaths had decreased by 97 % . There was a concomitant marked and sustained decline in notified malaria throughout the province . No serious adverse events were associated causally with AL treatment in an active sentinel pharmacovigilance survey . In a prospect i ve study with 42 d follow up , AL cured 97/98 ( 99 % ) and prevented gametocyte developing in all patients . Consistent with the findings of focus group discussion s , a household survey found self-reported adherence to the six-dose AL regimen was 96 % . CONCLUSION Together with concurrent strengthening of vector control measures , the antimalarial treatment policy change to AL in KwaZulu-Natal contributed to a marked and sustained decrease in malaria cases , admissions , and deaths , by greatly improving clinical and parasitological cure rates and reducing gametocyte carriage Pregnant women participating in a longitudinal immuno-epidemiologic survey in Lambaréné , Gabon , and presenting with Plasmodium falciparum parasitemia at monthly blood smear examinations were offered treatment with oral 7-day quinine monotherapy according to national health guidelines . A total of 50 pregnant women were offered 7-day oral quinine sulfate 10 mg/kg thrice daily . Clinical examinations and laboratory tests were performed on Days 28 and 56 to assess the effectiveness of this st and ard regimen . By Day 28 , the effectiveness of the 7-day quinine regimen was 60 % ( 95 % confidence interval : 46 - 72 % ) . We conclude that a 7-day course of quinine has a poor effectiveness and that alternative treatment regimens for malaria in pregnant women should be assessed BACKGROUND Artemisinin-based combination therapies are the recommended first-line treatments of falciparum malaria in all countries with endemic disease . There are recent concerns that the efficacy of such therapies has declined on the Thai-Cambodian border , historically a site of emerging antimalarial-drug resistance . METHODS In two open-label , r and omized trials , we compared the efficacies of two treatments for uncomplicated falciparum malaria in Pailin , western Cambodia , and Wang Pha , northwestern Thail and : oral artesunate given at a dose of 2 mg per kilogram of body weight per day , for 7 days , and artesunate given at a dose of 4 mg per kilogram per day , for 3 days , followed by mefloquine at two doses totaling 25 mg per kilogram . We assessed in vitro and in vivo Plasmodium falciparum susceptibility , artesunate pharmacokinetics , and molecular markers of resistance . RESULTS We studied 40 patients in each of the two locations . The overall median parasite clearance times were 84 hours ( interquartile range , 60 to 96 ) in Pailin and 48 hours ( interquartile range , 36 to 66 ) in Wang Pha ( P<0.001 ) . Recrudescence confirmed by means of polymerase-chain-reaction assay occurred in 6 of 20 patients ( 30 % ) receiving artesunate monotherapy and 1 of 20 ( 5 % ) receiving artesunate-mefloquine therapy in Pailin , as compared with 2 of 20 ( 10 % ) and 1 of 20 ( 5 % ) , respectively , in Wang Pha ( P=0.31 ) . These markedly different parasitologic responses were not explained by differences in age , artesunate or dihydroartemisinin pharmacokinetics , results of isotopic in vitro sensitivity tests , or putative molecular correlates of P. falciparum drug resistance ( mutations or amplifications of the gene encoding a multidrug resistance protein [ PfMDR1 ] or mutations in the gene encoding sarco-endoplasmic reticulum calcium ATPase6 [ PfSERCA ] ) . Adverse events were mild and did not differ significantly between the two treatment groups . CONCLUSIONS P. falciparum has reduced in vivo susceptibility to artesunate in western Cambodia as compared with northwestern Thail and . Resistance is characterized by slow parasite clearance in vivo without corresponding reductions on conventional in vitro susceptibility testing . Containment measures are urgently needed . ( Clinical Trials.gov number , NCT00493363 , and Current Controlled Trials number , IS RCT N64835265 . Objective To compare the effectiveness of oral quinine with that of artemether-lumefantrine in treating uncomplicated malaria in children . Design R and omised , open label effectiveness study . Setting Outpatient clinic of Ug and a ’s national referral hospital in Kampala . Participants 175 children aged 6 to 59 months with uncomplicated malaria . Interventions Participants were r and omised to receive oral quinine or artemether-lumefantrine administered by care givers at home . Main outcome measures Primary outcomes were parasitological cure rates after 28 days of follow-up unadjusted and adjusted by genotyping to distinguish recrudescence from new infections . Secondary outcomes were adherence to study drug , presence of gametocytes , recovery of haemoglobin concentration from baseline at day 28 , and safety profiles . Results Using survival analysis the cure rate unadjusted by genotyping was 96 % for the artemether-lumefantrine group compared with 64 % for the quinine group ( hazard ratio 10.7 , 95 % confidence interval 3.3 to 35.5 , P=0.001 ) . In the quinine group 69 % ( 18/26 ) of parasitological failures were due to recrudescence compared with none in the artemether-lumefantrine group . The mean adherence to artemether-lumefantrine was 94.5 % compared with 85.4 % to quinine ( P=0.0008 ) . Having adherence levels of 80 % or more was associated with a decreased risk of treatment failure ( 0.44 , 0.19 to 1.02 , P=0.06 ) . Adverse events did not differ between the two groups . Conclusions The effectiveness of a seven day course of quinine for the treatment of uncomplicated malaria in Ug and an children was significantly lower than that of artemether-lumefantrine . These findings question the advisability of the recommendation for quinine therapy for uncomplicated malaria in Africa . Trial registration Clinical Trials.gov NCT00540202 BACKGROUND Artemisinin-based drug combinations are the mainstay in the fight against drug-resistant malaria in Africa . Currently available antimalarial drug combinations that include artemisinins are pharmacokinetically unmatched and are therefore potentially increasing the risk of selection of resistant mutants in areas in which the rate of transmission of malaria is high . We tested the potential value of artemisinin-based combination therapy with a short elimination half-life for the treatment of uncomplicated Plasmodium falciparum malaria in sub-Saharan Africa . METHODS We conducted an open-label , r and omized , controlled clinical trial to evaluate the efficacy and tolerability of oral artesunate-clindamycin therapy given twice daily for 3 days ( artesunate , 2 mg/kg , and clindamycin , 7 mg/kg , per dose ) , compared with a st and ard quinine-clindamycin regimen given twice daily for 3 days ( quinine , 15 mg/kg , and clindamycin , 7 mg/kg , per dose ) , for the treatment of uncomplicated falciparum malaria in 100 Gabonese children aged 3 - 12 years . The primary end point of the study was the polymerase chain reaction-corrected cure rate for the per- protocol population . RESULTS The activity of artesunate-clindamycin was comparable to that of quinine-clindamycin in the per- protocol analysis of cure rates at day 28 of follow-up ( 87 % versus 94 % ) . No serious adverse events were reported , and tolerability was good and was similar in both groups . Times to clearance of fever and clearance of parasites were significantly shorter in the artesunate-clindamycin group . CONCLUSIONS Artesunate-clindamycin and other matching artemisinin-based combinations with a short plasma half-life merit further attention for use in regions in which the rate of transmission of malaria is high ABSTRACT Therapeutic responses to clindamycin in combination with quinine were assessed in adult Thai patients with uncomplicated multidrug-resistant Plasmodium falciparum malaria . In total 204 patients were r and omized to receive a 7-day oral treatment regimen of quinine ( Q7 ) either alone ( n = 68 ) , in combination with clindamycin ( Q7C7;n = 68 ) , or in combination with tetracycline ( Q7T7 ; n = 68 ) . All patients had uncomplicated recoveries with no serious adverse effects . Fever clearance times for both of the two combination regimens ( median of 47 h and range of 8 to 120 h for Q7C7 and median of 36 h and range of 8 to 117 h for Q7T7 ) were significantly shorter than that for the Q7-only regimen ( median , 56 ; range , 4 to 152 h ) ( P = 0.002 ) . Parasite clearance times ( overall mean ± st and ard deviation , 78 ± 23 h ) were not significantly different between the three treatment groups ( P = 0.98 ) . The cure rates assessed at 28 days of follow-up were 100 % for Q7C7 and 98 % for Q7T7 , whereas the cure rate was 87 % for the Q7-only regimen ( P ≤ 0.04 ) . Clindamycin in combination with quinine is a safe and effective treatment for multidrug-resistant P. falciparum malaria . This combination may be of particular value in children and pregnant women , in whom tetracyclines are contraindicated ABSTRACT We conducted a r and omized , double-blind , placebo-controlled trial to compare a 3-day quinine-clindamycin regimen ( group QC ) with a 7-day quinine regimen ( group Q ) for the treatment of uncomplicatedPlasmodium falciparum malaria in travelers returning from the tropics . A total of 55 and 53 patients in groups Q and QC were analyzed , respectively . Adverse effects were similar in both groups , although two patients in group Q had severe adverse reactions , leading to the cessation of treatment . The 28-day cure rate for the evaluated patients ( per- protocol analysis ) was 100 % for group QC , whereas it was 96.3 % for group Q ( P = 0.5 ) . The 28-day cure rate in the intention-to-treat analysis was 96.2 % for group QC , whereas it was 94.6 % for group Q ( P = 1 ) . There were no significant differences between the two regimens with regard to parasite and fever clearance times . Our study shows that the 3-day quinine-clindamycin regimen is well tolerated and compares favorably with a 7-day quinine treatment . This short-term regimen had previously been evaluated only in areas of endemicity . According to our results , the 3-day quinine-clindamycin regimen may be an alternative for the treatment of imported uncomplicated P. falciparum malaria in travelers returning from the tropics In this open r and omized trial comparing 3-day oral quinine-clindamycin versus st and ard mefloquine regimen for uncomplicated imported falciparum malaria , mefloquine treatment was associated with a higher risk of discontinuation of the treatment ( RR=1.8 , 95 % CI [ 1.1 - 2.8 ] ) related to mainly mild gastrointestinal adverse drug events . The poor tolerability of mefloquine sets a question mark against its use in out patients The frequency of antibiotic-associated diarrhoea ( AAD ) and Clostridium difficile-associated diarrhoea ( CdAD ) was prospect ively determined in a population of 2462 patients recruited from five Swedish hospitals , including divisions for infectious diseases , orthopaedics , surgery , geriat
Output:
| Adverse events were similar across treatment groups but were poorly reported . |
MS212987 | ***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 & AIM The immunomodulating nutrition was supposed to reduce the incidence of complications in surgical patients , but many authors have question ed its value recently . The aim of the study was to assess the impact of enteral immunonutrition in postoperative period . METHODS Between January 2003 and December 2009 , 305 malnourished patients ( 123 F , 182 M , m. age 60.8 ) undergoing resection for pancreatic or gastric cancer , after preoperative 14 days of parenteral feeding , were r and omized in double-blind manner to receive either postoperative immunomodulating enteral diet ( IMEN ) or st and ard oligopeptide diet ( SEN ) . Outcome measures of the intend-to-treat analysis were : number and type of complications , length of hospitalization , mortality , and vital organ function . RESULTS Median postoperative hospital stay was 17.1 days in SEN and 13.1 days in IMEN group ( p = 0.006 ) . Infectious complications were observed in 60 patients ( 39.2 % ) in SEN and 43 ( 28.3 % ) in IMEN group ( p = 0.04 ) . Differences were also observed in overall morbidity ( 47.1 vs 33.5 % , p = 0.01 ) and mortality ( 5.9 vs 1.3 % , p = 0.03 ) , but the ratio of surgical complications , organ function , and treatment tolerance did not differ . CONCLUSIONS The study proved that postoperative immunomodulating enteral nutrition should be the treatment of choice in malnourished surgical cancer patients . The Clinical Trials Data base registry number : NCT00576940 OBJECTIVES To study the impact of different adherence levels to the enhanced recovery after surgery ( ERAS ) protocol and the effect of various ERAS elements on outcomes following major surgery . DESIGN Single-center prospect i ve cohort study before and after reinforcement of an ERAS protocol . Comparisons were made both between and across periods using multivariate logistic regression . All clinical data ( 114 variables ) were prospect ively recorded . SETTING Ersta Hospital , Stockholm , Sweden . PATIENTS Nine hundred fifty-three consecutive patients with colorectal cancer : 464 patients treated in 2002 to 2004 and 489 in 2005 to 2007 . MAIN OUTCOME MEASURES The association between improved adherence to the ERAS protocol and the incidence of postoperative symptoms , complications , and length of stay following major colorectal cancer surgery was analyzed . RESULTS Following an overall increase in preoperative and perioperative adherence to the ERAS protocol from 43.3 % in 2002 to 2004 to 70.6 % in 2005 to 2007 , both postoperative complications ( odds ratio , 0.73 ; 95 % confidence interval , 0.55 - 0.98 ) and symptoms ( odds ratio , 0.53 ; 95 % confidence interval , 0.40 - 0.70 ) declined significantly . Restriction of intravenous fluid and use of a preoperative carbohydrate drink were major independent predictors . Across periods , the proportion of adverse postoperative outcomes ( 30-day morbidity , symptoms , and readmissions ) was significantly reduced with increasing adherence to the ERAS protocol ( > 70 % , > 80 % , and > 90 % ) compared with low ERAS adherence ( < 50 % ) . CONCLUSION Improved adherence to the st and ardized multimodal ERAS protocol is significantly associated with improved clinical outcomes following major colorectal cancer surgery , indicating a dose-response relationship OBJECTIVE To evaluate the influence of postoperative immunonutrition on immune and nutritional parameters in patients with gastric carcinoma . METHODS From September 2002 to August 2003 , 40 patients with gastric carcinoma who had undergone major surgery were r and omly divided into an immunonutrition group and st and ard nutrition group , each of 20 patients . On postoperative Day 2 , patients in the st and ard nutrition group received a st and ard enteral formula , while those in the immunonutrition group received an enteral formula enriched with glutamine , arginine and omega-3 fatty acids . Nutritional support was continued for 7 days . Blood sample s were obtained to determine plasma albumin , prealbumin and transferrin on Days 0 , 5 and 9 . On Days 0 , 1 and 9 , blood sample s were collected to detect immunoglobulin ( Ig ) A , IgG , IgM , CD4 and CD8 cell counts , the ratio of CD4/CD8 , interleukin (IL)-2 , IL-6 and tumour necrosis factor (TNF)-alpha , respectively . RESULTS There were no significant differences between the two groups in protein and immune parameters preoperatively and no significant differences in management perioperatively . No serious adverse effects were recorded with the two formulas . Postoperative procedures were smooth in both groups . On Day 9 , serum levels of prealbumin and transferrin were higher in the immunonutrition group than in the st and ard nutrition group ( p<0.01 ) . After 7 days ' nutritional support , patients in the immunonutrition group had higher levels of immunoglobulin , CD4 cell counts , CD4/CD8 ratio and IL-2 than those in the control group , whereas IL-6 and TNF-alpha levels were significantly lower in the immunonutrition group . CONCLUSION Compared with st and ard enteral nutrition , enteral immunonutrition can improve defence mechanisms and modulate inflammatory action after major elective surgery for gastric carcinoma Objective The authors determined the effect of glutamine-supplementation of TPN on postoperative peripheral blood T-cell response and proinflammatory cytokine production in patients undergoing colorectal resection . Summary Background Data Several vital tissues , including the immune system , are very dependent on glutamine ; however , this amino acid , which may be essential in conditions of stress , only now is becoming formulated suitably for incorporation into TPN . The effects of such supplementation on the immune function of stressed surgical patients is unknown . Methods Patients ( n = 20 ) were r and omized to receive conventional TPN ( 0.2 g nitrogen/kg/d ) or an isonitrogenous/isocaloric regimen with 0.18 g of glutamine/kg/d from days 1 to 6 postoperatively . T-cell DNA synthesis and interleukin (IL)-2 production and peripheral blood mononuclear cell IL-6 and tumor necrosis factor ( TNF ) production were measured in vitro preoperatively and on days 1 and 6 postoperatively . Results T-cell DNA synthesis after 5 days of TPN was increased compared with preoperative values in the glutamine-supplemented group ( median preoperative tritiated thymidine uptake : 78.3 X 103 cpm , day 6 : 95.0 X 103 cpm , p < 0.05 ) . There was no such increase in the control TPN group ( preoperative : 89.0 X 103 cpm , day 6 : 69.4 X 103 cpm , p > 0.05 ) . Glutamine supplementation did not influence IL-2 production or the production of TNF or IL-6 . Conclusions Glutamine supplementation may be a method of enhancing T-cell function in the surgical patient receiving TPN Specific immunonutrients may reduce the incidence of postoperative complications and shorten recovery time . This r and omized trial evaluated the clinical efficacy of a fish oil emulsion on outcome and immune function after gastrointestinal cancer surgery BACKGROUND & AIMS Malnutrition is a recognized risk factor for perioperative morbidity , but there is currently no st and ardized definition of malnutrition . The Nutrition Risk Screening 2002 score was recently proposed to identify patients at nutritional risk who may benefit from nutritional support therapy , and has been officially adopted by the European Society of Parenteral and Enteral Nutrition . The aim of this study was to assess the value of the Nutrition Risk Screening 2002 score in predicting the incidence and severity of postoperative complications in gastrointestinal surgery . METHODS We prospect ively evaluated 608 patients admitted for elective gastrointestinal surgery . Nutritional risk was defined by the Nutrition Risk Screening 2002 score and correlated to the incidence and severity of postoperative complications . Complications were classified using an established surgical complication classification . RESULTS The overall incidence of nutritional risk was 14 % . We observed a significantly higher complication rate of 40 % ( 35 out of 87 ) in patients at nutritional risk , compared to 15 % ( 81 out of 521 ) in patients with a normal score ( p<0.001 ) . The incidence of severe complications was significantly higher in patients at nutritional risk ( 54 % versus 15 % ; p<0.001 ) . The odds ratio to develop a complication was 2.8 in patients at risk ( p=0.001 ) , and 3.0 in patients with malignant disease ( p<0.001 ) . The median length of stay in nutritional risk patients was significantly longer ( 10 versus 4 days , p<0.001 ) . CONCLUSION The prevalence of nutritional risk patients in gastrointestinal surgery is high . We showed that nutritional risk screening using the NRS 2002 strongly predicts the incidence and severity of complications BACKGROUND Malnutrition in gastrointestinal ( GI ) surgery is associated with increased morbidity . Therefore , careful screening remains crucial to identify patients at risk for malnutrition and consequently postoperative complications . The aim of this study was to evaluate the ability of 3 established score systems to identify patients at risk of developing postoperative complications in GI surgery and to assess the correlation among the score systems . METHODS We evaluated prospect ively 200 patients admitted for elective GI surgery using ( 1 ) nutrition risk index , ( 2 ) nutrition risk score , and ( 3 ) bioelectrical impedance analysis . Complications were assessed using a st and ardized complication classification . The findings of the score systems were correlated with the incidence and severity of complications . Parametric and nonparametric correlation analysis was performed among the different score systems . RESULTS All 3 score systems correlated significantly with the incidence and severity of postoperative complications and the duration of hospital stay . Using multiple regression analysis , only nutrition risk score and malignancy remained prognostic factors for the development of complications with odds ratios of 4.2 ( P = .024 ) and 5.6 ( P < .001 ) , respectively . The correlation between nutrition risk score and nutrition risk index was only moderate ( Pearson coefficient = 0.54 ) . Bioelectrical impedance analysis displayed only weak to trivial correlation to the nutrition risk index ( 0.32 ) and nutrition risk score ( 0.19 ) , respectively . CONCLUSION The nutrition risk score , nutrition risk index , and bioimpedance analysis correlate with the incidence and severity of perioperative complications in GI surgery . The nutrition risk score was the best score in predicting patients who will develop complications in this study population . The correlation between the individual scores was only moderate , and therefore , they do not necessarily identify the same patients BACKGROUND The aim of this trial was to compare multimodal optimization with conventional perioperative management in a consecutive series of patients undergoing gastrectomy procedures . METHODS According to r and omized controlled studies and conclusions made by meta-analyses in colorectal surgery , optimized perioperative measures were design ed and applied in gastrectomy surgery . Thirty-three patients were r and omized to the optimized group and 30 patients to a control group . Two groups were treated in 1 center by a single surgical team in different wards . Both groups used patient-controlled intravenous analgesia for postoperative analgesia . The primary end point was length of postoperative hospital stay . Secondary outcomes included bowel function recovery after surgery , perioperative changes of inflammatory factors , glucocorticoid , insulin resistance , and body composition . Perioperative complications and adverse events were also recorded . RESULTS The groups were similar in terms of age , sex ratio , and Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity ( POSSUM score ) . The optimized group was associated with a significantly shorter postoperative hospital stay compared with the conventional care group ( P < .001 ) . Duration s of urinary catheterization and abdominal drainage were also less ( P < .001 ) . The diet program in the optimization group was well tolerated and was associated with an earlier recovery of gut function ( P < .001 ) . Proinflammatory factors were less elevated and body composition was more stable in the optimized group than in controls . There were no differences in morbidity or mortality between the groups . CONCLUSIONS Optimization of care in gastrectomy can shorten postoperative hospital stay and provides multiple beneficial outcomes , including hastening the return of gut function , without increasing morbidity Surgical injury provokes a stress response that leads to a catabolic state and , when prolonged , interferes with the postoperative recovery process . This study tests the impact of 2 nutrition support regimens on protein and glucose metabolism as part of an integrated approach in the perioperative period incorporating epidural analgesia in 18 nondiabetic patients undergoing colorectal surgery .
Output:
| Several controlled r and omized studies and systematic review s indicate that immune nutrition formulas reduce both morbidity and length of stay after major abdominal surgery .
Current data shows that the use of perioperative immunonutrition diets for major abdominal surgery is beneficial . |
MS212988 | ***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 investigate the relationship of smoking with the rate of pseudarthrosis ( surgical nonunion ) , 50 patients , who were smokers , and 50 patients , who were not , and who had had a two-level laminectomy and fusion during 1977 and 1978 were r and omly selected for this study . Most of those participating had sustained job-related injuries whereas the others had no common etiology for their back dysfunction . Most of the patients were from the southeastern United States . Ages ranged from 23 to 62 years , with a mean age of 42.4 years for smokers and 42.7 years for nonsmokers . There was an equal representation of males and females , with minorities represented according to their general percentage in the population . Examination 1 to 2 years after surgery revealed that 40 % ( 20 ) of the smokers had developed a pseudarthrosis , whereas among nonsmokers , the rate was 8 % ( 4 ) . This finding appears to be independent of age , sex , or race and was statistically significant ( χ2=14.035 , p=.001 ) . It was hypothesized that the higher incidence of surgical nonunion among smokers may be related to blood gas levels . Nonsmokers showed no significant deficiencies , whereas smokers showed a mean PO2 level of 78.5 % ( normal=95 - 97 ) and a mean O2 saturation level of 92.9 % ( normal=95 or above ) . Implication s and suggestions for further research are also discussed The aim of this controlled , clinical study was to evaluate guided tissue regeneration using a bioabsorbable membrane in periodontal intraosseous defects . Forty patients , each contributing one defect > or = 4 mm in depth participated . The control group ( 18 individuals ) received conventional flap therapy , while the test group ( 22 individuals ) was treated using the bioabsorbable membrane , Guidor . Clinical assessment s were made by one examiner , blinded with respect to treatment group , at baseline , 6 and 12 months following surgery . Baseline probing pocket depths of 7.7+/-1.4 mm in the membrane group and 7.6+/-1.9 mm in the control group were measured . Twelve month results showed a significant clinical attachment level gain in both control ( 1.1+/-1.8 mm ) , and membrane group ( 1.3+/-2.1 mm ) . Probing pocket depth reduction of 2.6+/-1.9 mm and 2.7+/-1.9 mm was observed in the respective groups . Bone sounding showed a non-significant gain of 0.4+/-1.8 mm and 0.6+/-1.4 mm at membrane and control sites , respectively . Radiographic evaluation confirmed these results . There were no significant differences found between treatment groups for any of the tested variables . Smoking had a negative effect on healing in both groups . In conclusion , clinical and radiographic results indicate that guided tissue regeneration using a bioabsorbable membrane at intraosseous defects did not predictably achieve greater clinical attachment level gain nor bone gain when compared to conventional flap therapy We retrospectively review ed a prospect ively followed cohort of 105 patients with 110 open tibia fractures treated with external fixator or intramedullary nail to determine whether smoking affects fracture healing . Severe open tibia-shaft fractures treated at a tertiary-care medical center were included . Patients with type II , IIIA , or IIIB tibia fractures were eligible . Treatment for all patients was similar , except that they were r and omized to receive external fixator or intramedullary nail . Time to fracture healing was the main outcome measurement . Smokers had a union rate of 84 % ( 52/62 ) , and nonsmokers had a union rate of 94 % ( 45/48 ) , P = .10 . For smokers in one arm of the study , time to union was significantly longer ( P = .01 ) , and there were more complications ( P = .04 ) . Smoking decreased unions , slowed healing , and increased complications Objectives : Current data show smoking is associated with a number of complications of the fracture healing process . A concern , however , is the potential confounding effect of covariates associated with smoking . The present study is the first to prospect ively examine time to union , as well as major complications of the fracture healing process , while adjusting for potential confounders . Setting : Eight Level I trauma centers . Patients : Patients with unilateral open tibia fractures were divided into 3 baseline smoking categories : never smoked ( n = 81 ) , previous smoker ( n = 82 ) , and current smoker ( n = 105 ) . Outcome Measure : Time to fracture healing , diagnosis of infection , and osteomyelitis . Methods : Survival and logistic analyses were used to study differences in time to fracture healing and the likelihood of developing complications , respectively . Multivariate models were used to adjust for injury severity , treatment variations , and patient characteristics Results : After adjusting for covariates , current and previous smokers were 37 % ( P = 0.01 ) and 32 % ( P = 0.04 ) less likely to achieve union than nonsmokers , respectively . Current smokers were more than twice as likely to develop an infection ( P = 0.05 ) and 3.7 times as likely to develop osteomyelitis ( P = 0.01 ) . Previous smokers were 2.8 times as likely to develop osteomyelitis ( P = 0.07 ) , but were at no greater risk for other types of infection . Conclusion : Smoking places the patient at risk for increased time to union and complications . Previous smoking history also appears to increase the risk of osteomyelitis and increased time to union . The results highlight the need for orthopaedic surgeons to encourage their patients to enter a smoking cessation programs The aim of the present clinical trial was to evaluate the effect of different modes of periodontal therapy on patients with moderately advanced periodontal disease and to express the findings in terms of probing pocket depth and attachment level alterations at periodontal sites with different initial probing depths . The material consisted of 16 patients , 35 - 65 years of age . Following a Baseline examination including assessment s of oral hygiene status , gingival conditions , probing pocket depths and probing attachment levels , the patients were subjected to periodontal treatment . A " split-mouth " design approach of therapy was used and the jaw quadrants were r and omly selected for the following different treatment procedures : ( 1 ) scaling and root planning , ( 2 ) scaling and root planing in conjunction with a gingivectomy procedure , ( 3 ) scaling and root planing in conjunction with an apically repositioned flap procedure without bone recontouring , ( 4 ) scaling and root planing in conjunction with an apically repositioned flap procedure including bone recontouring , ( 5 ) scaling and root planing in conjunction with a modified Widman flap procedure without bone recontouring and ( 6 ) scaling and root planing in conjunction with a modified Widman flap procedure including bone recontouring . The patients were following active treatment enrolled in a supervised maintenance care program including " professional tooth cleaning " once every 2 weeks during a 6-month period of healing , after which a final examination was performed . The investigation demonstrated that active therapy including meticulous subgingival debridement result ed in a low frequency of gingival sites which bled on probing , a high frequency of sites with shallow pockets ( less than 4 mm ) and the disappearance of pockets with a probing depth of greater than 6 mm . Between the Baseline examination and the 6-month re-examination , the probing attachment level for initially shallow pockets remained basically unaltered , but with a tendency of a minor apical shift . This occurred in all 6 treatment groups . For sites with initial probing depths of 4 - 6 mm and greater than 6 mm , there was in all groups some gain of probing attachment . This gain was most pronounced in the initially deeper ( greater than 6 mm ) pockets . With the use of regression analysis , the " critical probing depth " ( CPD ) value ( i.e. the initial probing depth value below which loss of attachment occurred as a result of treatment and above which gain of probing attachment level result ed ) was calculated for each of the 6 methods of treatment used . A comparison of the CPD-values between the 6 treatment groups did not reveal any major differences OBJECTIVES Current literature is ambivalent on the use of barrier membranes for regeneration of intraosseous defects . One of the reasons for unpredictable results may be related to infection before , during and after the surgical procedure . Therefore , the purpose of the present controlled study was to evaluate both the use of membranes ( MEM ) and antibiotics ( AB ) , separately and in combination . METHODS In all , 25 patients with two intraosseous periodontal defects each were r and omized in two groups : AB+ group receiving systemic antibiotics ( n = 13 ) and AB- group without antibiotics ( n = 12 ) . After raising flaps and after debridement , both defects in each patient were covered by a bioresorbable membrane ( MEM+ ) . However , just before suturing the flaps in a coronal position , the membrane over one of the two defects was removed at r and om ( MEM- ) . This protocol result ed in four groups of defects : ( i ) . MEM- AB- ; ( ii ) . MEM+ AB- ; ( iii ) . MEM- AB+ ; ( iv ) . MEM+ AB+ . Patients were monitored clinical ly and microbiologically for 1 year . Data were analyzed in repeated measures ancova 's and adjusted means for clinical variables were obtained from the final statistical model . RESULTS Reduction in probing pocket depth ( PPD ) at 12 months postoperatively varied between 2.54 and 3.06 mm between the four treatment modalities , but overall no main effect of MEM or AB was found . Gains in probing attachment level ( PAL ) at 12 months postoperatively varied between 0.56 and 1.96 mm for the 4 treatments . In the overall analysis for PAL , no main effect of MEM or AB was found . Gains in probing bone level ( PBL ) 12 months postoperatively ranged from 1.39 to 2.09 mm between the treatment groups . Again , overall , no main effects of MEM or AB were found for PBL . Explorative statistical analyses indicated that smoking and not MEM or AB is a determining factor for gain in PBL ( P = 0.0009 ) . Nonsmokers were estimated to gain 2.04 mm PBL compared to 0.52 mm in smokers . The prevalence of several periodontal pathogens , at the day of surgery or postoperatively , and specific defect characteristics , were not determining factors for gain in PAL and PBL . CONCLUSIONS Neither the application of barrier membranes nor the use of systemic antibiotics showed an additional effect over control on both soft and hard tissue measurements in the treatment of intraosseous defects . In contrast , smoking was a determining factor severely limiting gain in PBL in surgical procedures aim ed at regeneration of intraosseous defects The role of smoking as a risk factor for periodontitis was assessed separately in diabetic and nondiabetic study groups . Subject listings stratified for age ( 19 to 40 years ) and sex were obtained for subjects with insulin-dependent diabetes mellitus ( IDDM ) and nondiabetic subjects . For both the IDDM group ( n = 132 ) and the nondiabetic group ( n = 95 ) , age and sex stratified sample s were constructed by r and om selection of subjects from each subject listing . Patients were recruited by phone , examined , and their medical and dental histories obtained . Among nondiabetic subjects , the prevalence of periodontitis was markedly higher among current smokers compared with never smokers ( P < or = 0.005 ) in both the 19 to 30 year-old ( 46 % vs. 12 % ) and 31 to 40 year-old groups ( 88 % vs. 33 % ) . The subject mean percent of sites with gingival pocket depth > or = 4 mm was higher among current smokers than never smokers ( P = 0.001 ) in the 19 to 30 ( 8.2 % vs. 3.4 % ) and 31 to 40 ( 14.3 % vs. 4.3 % ) age groups . The effects of smoking among IDDM subjects were similar to that observed in the nondiabetic population . There were no differences between current and never smokers in the proportion of sites positive for plaque . Attributable risk percents from prevalence data suggest that among nondiabetic subjects , a large proportion , perhaps as much as 51 % of the periodontitis in the 19 to 30 year old group and 32 % of the periodontitis in the 31 to 40 year old group , is associated with smoking . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND The purpose of this r and omized , controlled , blinded , clinical investigation was to determine the effect of postsurgical antibiotics on osseous healing in Class II furcation defects . METHODS Twenty-four Class II furcation defects in 24 patients were treated with either a polylactide bioabsorbable membrane , demineralized freeze-dried bone allograft ( DFDBA ) plus antibiotics ( GBA or test group ) or with a polylactide membrane and DFDBA alone ( GB or control group ) . Twelve patients were included in each group . The antibiotic regimen consisted of ciprofloxacin 250 mg twice daily and metronidazole 250 mg tid for 1 week followed by a 7-week regimen of doxycycline hy
Output:
| Smoking has a negative effect on bone regeneration after periodontal treatment .
Patients should be advised that their smoking habit may result in poorer bone regeneration after periodontal treatment |
MS212989 | ***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 Recommending increased physical activity facilitates long-term weight loss , but the optimal level of physical activity to recommend is unknown . OBJECTIVE The objective of the study was to evaluate the efficacy for long-term weight loss of recommendations for much higher physical activity than those normally used in behavioral treatments . DESIGN Overweight men and women ( n = 202 ) were r and omly assigned to either a st and ard behavior therapy ( SBT ) for obesity , incorporating an energy expenditure ( EE ) goal of 1000 kcal/wk , or to a high physical activity ( HPA ) treatment , in which the goal was an EE of 2500 kcal/wk . To help HPA treatment group participants achieve this high exercise goal , their treatment included encouragement to recruit 1 - 3 exercise partners into the study , personal counseling from an exercise coach , and small monetary incentives . RESULTS The HPA treatment group reported achieving higher mean ( + /- SD ) physical activity levels than did the SBT group at 6 mo ( EE of 2399 + /- 1571 kcal/wk compared with 1837 + /- 1431 kcal/wk ) , 12 mo ( EE of 2249 + /- 1751 kcal/wk compared with 1565 + /- 1309 kcal/wk ) , and 18 mo ( EE of 2317 + /- 1854 kcal/wk compared with 1629 + /- 1483 kcal/wk ) ( all P < 0.01 ) . Mean ( + /- SEM ) cumulative weight losses at 6 , 12 , and 18 mo in the HPA treatment group were 9.0 + /- 7.1 , 8.5 + /- 7.9 , and 6.7 + /- 8.1 kg , respectively . In the SBT group , the corresponding weight losses were 8.1 + /- 7.4 , 6.1 + /- 8.8 , and 4.1 + /- 7.3 kg , respectively . Between-group differences in weight loss were significant at 12 and 18 mo . CONCLUSION These results suggest that recommendations of higher levels of physical activity ( EE of 2500 kcal/wk ) promote long-term weight loss better than do conventional recommendations The National Weight Control Registry ( NWCR ) is , to the best of our knowledge , the largest study of individuals successful at long-term maintenance of weight loss . Despite extensive histories of overweight , the 629 women and 155 men in the registry lost an average of 30 kg and maintained a required minimum weight loss of 13.6 kg for 5 y. A little over one-half of the sample lost weight through formal programs ; the remainder lost weight on their own . Both groups reported having used both diet and exercise to lose weight and nearly 77 % of the sample reported that a triggering event had preceded their successful weight loss . Mean ( + /-SD ) current consumption reported by registry members was 5778 + /- 2200 kJ/d , with 24 + /- 9 % of energy from fat , Members also appear to be highly active : they reported expending approximately 11830 kJ/wk through physical activity . Surprisingly , 42 % of the sample reported that maintaining their weight loss was less difficult than losing weight . Nearly all registry members indicated that weight loss led to improvements in their level of energy , physical mobility , general mood , self-confidence , and physical health . In summary , the NWCR identified a large sample of individuals who were highly successful at maintaining weight loss . Future prospect i ve studies will determine variables that predict continued maintenance of weight loss Exercise is frequently identified as a predictor of weight maintenance after elective weight loss in retrospective studies of treatments for obesity . We conducted a prospect i ve study to test whether physical activity measured soon after weight loss predicted weight maintenance and to determine how much physical activity was required to optimize maintenance . Thirty-two women [ mean ( + /- SD ) age , 38 + /- 7 y ; body mass index ( in kg/m2 ) , 24 + /- 3 ] were recruited through local advertising within 3 mo of reaching their target for weight loss ( 23 + /- 9 kg ) . Total energy expenditure ( TEE ) was measured by the doubly labeled water method . Postabsorptive resting metabolic rate ( RMR ) and postpr and ial RMR [ expressed as thermic effect of a meal ( TEM ) ] were measured by respiratory gas exchange . Women in the physically active group ( ratio of TEE to RMR = 1.89 + /- 0.08 ) gained 2.5 + /- 3.1 kg during the 12 mo after reaching their target for weight loss , moderately active women ( TEE : RMR = 1.64 + /- 0.05 ) gained 9.9 + /- 10.5 kg , and sedentary women ( TEE : RMR = 1.44 + /- 0.08 ) gained 7.0 + /- 5.9 kg ( P < 0.01 ) . Retrospective analyses of weight regain as a function of energy expended in physical activity indicated a threshold for weight maintenance of 47 kJ x kg body wt(-1 ) x d(-1 ) . This corresponds to an average of 80 min/d of moderate activity or 35 min/d of vigorous activity added to a sedentary lifestyle A definitive model for predicting absolute risk of coronary heart disease ( CHD ) in male and female people with Type II diabetes is not yet available . This paper provides an equation for estimating the risk of new CHD events in people with Type II diabetes , based on data from 4540 U.K. Prospect i ve Diabetes Study male and female patients . Unlike previously published risk equations , the model is diabetes-specific and incorporates glycaemia , systolic blood pressure and lipid levels as risk factors , in addition to age , sex , ethnic group , smoking status and time since diagnosis of diabetes . All variables included in the final model were statistically significant ( P<0.001 , except smoking for which P=0.0013 ) in likelihood ratio testing . This model provides the estimates of CHD risk required by current guidelines for the primary prevention of CHD in Type II diabetes In 1997 , the World Health Organization published a l and mark document recognizing obesity as a worldwide disease that poses a serious threat to public health ( 1 ) . Persons who are overweight or obese have substantially increased risk for morbidity from numerous chronic disorders , such as diabetes ( 2 , 3 ) , hypertension ( 4 , 5 ) , and cardiovascular disease ( 6 , 7 ) . Obesity-related health risk is greater when excess fat is deposited in the abdomen region because this phenotype is a stronger predictor of cardiovascular disease and type 2 diabetes mellitus than general obesity is ( 8 - 11 ) . This may be partially explained by excess accumulation of visceral fat , an independent correlate of insulin resistance ( 9 - 11 ) and dyslipidemia ( 8 , 9 ) . These observations highlight the need to identify appropriate treatment strategies to prevent and reduce obesity and suggest that the effectiveness of these treatments would be enhanced if abdominal obesity , particularly visceral fat , was substantially reduced . Diet restriction remains the most common method of obesity reduction ( 12 ) . Despite the observation that low levels of physical activity are a major cause of obesity ( 13 ) , increased physical activity alone is not thought to be a useful strategy for obesity reduction . Some reports have suggested that physical activity in obese adults results in only modest weight loss ( approximately 1 to 2 kg ) independent of the effects of diet restriction ( 14 ) . However , these conclusions are drawn from studies in which individual energy intake and expenditure were not rigorously controlled or accurately measured ( 15 - 17 ) . Moreover , in most studies , the negative energy balance induced by exercise was modest enough that substantial weight loss was not expected ( 15 - 17 ) . Currently , no compelling evidence supports the observation that exercise alone is not a useful method for reducing total or abdominal obesity . It is well known that a single exercise session is associated with a significant improvement in insulin-stimulated glucose uptake ( 18 , 19 ) . It is also clear that weight loss is associated with an improvement in insulin action ( 20 - 24 ) . It is unclear , however , whether regular exercise improves glucose metabolism after the short-term effects of exercise and changes in body fat distribution are considered . Segal and colleagues ( 25 ) controlled for the confounding effect of the last exercise session and body composition changes and found that exercise had no independent effect on insulin sensitivity ( 25 ) . Given the established importance of insulin resistance as an antecedent to both cardiovascular disease and type 2 diabetes mellitus ( 26 ) , it is important to clarify whether exercise improves insulin action independent of fat loss . We performed a r and omized , controlled trial to determine the independent effect of diet-induced or exercise-induced weight loss on obesity and insulin resistance in moderately obese men . We also evaluated whether exercise without weight loss was associated with reductions in abdominal obesity and insulin resistance . Methods Participants Participants were recruited from Kingston , Ontario , Canada , a typical suburban region , through the general media . We selected men with a body mass index greater than 27 kg/m2 and a waist circumference greater than 100 cm whose weight had been stable ( 2 kg ) for 6 months before study entry . Participants were nonsmokers who consumed an average of fewer than two alcoholic beverages per day , had a sedentary lifestyle , and took no medications known to affect the principal outcome measures . All participants had a preparticipation medical examination that included screening for normal glucose tolerance and plasma lipid profile . A computer program was used to r and omly assign eligible men to one of the following four groups : control , diet-induced weight loss , exercise-induced weight loss , and exercise without weight loss ( Figure 1 ) . Of the 101 participants who were r and omly assigned to groups , 34 chose not to participate because they were dissatisfied with their assigned group , 5 were diabetic or dyslipidemic , and 3 were relocated because of job transfers . Those who chose not to participate and those who completed the trial were similar with regard to anthropometric variables . In addition , those who completed the trial were similar to those who did not in each group ( P > 0.10 ) . Baseline characteristics among groups were similar for all participants ( Table 1 ) . All participants gave fully informed written consent . The study was conducted in accordance with the ethical guidelines of Queen 's University . The participants did not receive monetary compensation . Figure 1 . Flow of participants through the study . Table 1 . Selected Anthropometric , Magnetic Resonance Imaging , and Metabolic Variables before Treatment and 3 Months after Treatment Diet and Exercise Regimen During the baseline period , daily energy requirements for all participants were determined by estimating resting energy expenditure and multiplying the obtained value by a factor of 1.5 ( 27 ) . All participants followed a weight maintenance diet ( 55 % to 60 % carbohydrate , 15 % to 20 % protein , and 20 % to 25 % fat ) for a 4- to 5-week baseline period . During this period , body weight was monitored to determine the accuracy of the prescribed energy requirement , which was adjusted accordingly to maintain body weight . Controls were asked to maintain body weight throughout the 12-week treatment period . Participants in the diet-induced weight loss group were asked to reduce the isocaloric diet by 700 kcal/d during the treatment period to achieve a weekly weight loss of approximately 0.6 kg . To lose the same amount of weight , participants in the exercise-induced weight loss group were asked to maintain the isocaloric diet for the duration of the treatment period and to perform exercise that expended 700 kcal/d . Participants assigned to exercise without weight loss were asked to maintain body weight . Therefore , they consumed enough calories to compensate for the energy expended during the daily exercise sessions ( approximately 700 kcal ) . At the end of the treatment period , isocaloric requirements were determined and prescribed for a 2-week weight stabilization period . All participants were free-living and consumed self-selected foods . No vitamins or other nutritional supplements were prescribed . Each person participated in a series of weekly 1-hour seminars in which a dietitian taught proper food selection and preparation . Participants were told that the composition of the maintenance and energy-reduced diets should be approximately 55 % to 60 % carbohydrate , 15 % to 20 % protein , and 20 % to 25 % fat . Participants kept and analyzed daily , detailed food records for the duration of the study period ( approximately 20 weeks ) ; the study dietitian also review ed these records . For the 2-week period during which doubly labeled water measurements were acquired ( weeks 6 and 7 ) , the diet records were analyzed by using a computerized program ( Food Processor , Esha Research , Salem , Oregon ) . Participants in both exercise groups performed daily exercise ( brisk walking or light jogging ) on a motorized treadmill for the duration of the 12-week trial . The length of each exercise session was determined by the time required to expend 700 kcal . Participants were asked to exercise at an intensity not greater than 70 % of their peak oxygen uptake ( Vo 2 ) ( approximately 80 % of maximal heart rate ) . Energy expenditure was determined by using the heart rate and oxygen consumption data that were obtained from the pretreatment grade d exercise test and were adjusted according to the results of two subsequent tests performed at weeks 4 and 8 . During each session , heart rate was monitored every 5 minutes by using an automated heart rate monitor ( Polar Oy , Kempele , Finl and ) . All exercise sessions were by appointment and were supervised . Peak Vo 2 was determined by using a grade d treadmill test and st and
Output:
| Therefore , there is firm and consistent evidence that programs of increased physical activity and modest weight loss reduce the incidence of type 2 diabetes in individuals with IGT .
In contrast , postintervention body weight did not differ between the exercise and control groups .
Meta-regression confirmed that the beneficial effect of exercise on A1C |
MS212990 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: AIM To evaluate the protocol -specified final analysis of overall survival ( OS ) in the KEYNOTE-002 study ( NCT01704287 ) of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory , advanced melanoma . METHODS In this r and omised , phase II study , eligible patients had advanced melanoma with documented progression after two or more ipilimumab doses , previous BRAF or MEK inhibitor or both , if BRAFV600 mutant-positive . Patients were r and omised to pembrolizumab 2 mg/kg or 10 mg/kg every 3 weeks or investigator-choice chemotherapy . Crossover to pembrolizumab was allowed following progression on chemotherapy . The protocol -specified final OS was performed in the intent-to-treat population . Survival was positive if p < 0.01 in one pembrolizumab arm . RESULTS A total of 180 patients were r and omised to pembrolizumab 2 mg/kg , 181 to pembrolizumab 10 mg/kg and 179 to chemotherapy . At a median follow-up of 28 months ( range 24.1 - 35.5 ) , 368 patients died and 98 ( 55 % ) crossed over to pembrolizumab . Pembrolizumab 2 mg/kg ( hazard ratio [ HR ] 0.86 , 95 % confidence interval [ CI ] 0.67 - 1.10 , p = 0.117 ) and 10 mg/kg ( 0.74 , 0.57 - 0.96 , p = 0.011 ) result ed in a non-statistically significant improvement in OS versus chemotherapy ; median OS was 13.4 ( 95 % CI 11.0 - 16.4 ) and 14.7 ( 95 % CI 11.3 - 19.5 ) , respectively , versus 11.0 months ( 95 % CI 8.9 - 13.8 ) , with limited improvement after censoring for crossover . Two-year survival rates were 36 % and 38 % , versus 30 % . Progression-free survival , objective response rate and duration of response improved with pembrolizumab versus chemotherapy , regardless of dose . Grade III-V treatment-related adverse events occurred in 24 ( 13.5 % ) , 30 ( 16.8 % ) and 45 ( 26.3 % ) patients , respectively . CONCLUSION Improvement in OS with pembrolizumab was not statistically significant at either dose versus chemotherapy BACKGROUND Limited evidence exists to show that adding a third agent to platinum-doublet chemotherapy improves efficacy in the first-line advanced non-small-cell lung cancer ( NSCLC ) setting . The anti-PD-1 antibody pembrolizumab has shown efficacy as monotherapy in patients with advanced NSCLC and has a non-overlapping toxicity profile with chemotherapy . We assessed whether the addition of pembrolizumab to platinum-doublet chemotherapy improves efficacy in patients with advanced non-squamous NSCLC . METHODS In this r and omised , open-label , phase 2 cohort of a multicohort study ( KEYNOTE-021 ) , patients were enrolled at 26 medical centres in the USA and Taiwan . Patients with chemotherapy-naive , stage IIIB or IV , non-squamous NSCLC without targetable EGFR or ALK genetic aberrations were r and omly assigned ( 1:1 ) in blocks of four stratified by PD-L1 tumour proportion score ( < 1 % vs ≥1 % ) using an interactive voice-response system to 4 cycles of pembrolizumab 200 mg plus carboplatin area under curve 5 mg/mL per min and pemetrexed 500 mg/m2 every 3 weeks followed by pembrolizumab for 24 months and indefinite pemetrexed maintenance therapy or to 4 cycles of carboplatin and pemetrexed alone followed by indefinite pemetrexed maintenance therapy . The primary endpoint was the proportion of patients who achieved an objective response , defined as the percentage of patients with radiologically confirmed complete or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1 assessed by masked , independent central review , in the intention-to-treat population , defined as all patients who were allocated to study treatment . Significance threshold was p<0·025 ( one sided ) . Safety was assessed in the as-treated population , defined as all patients who received at least one dose of the assigned study treatment . This trial , which is closed for enrolment but continuing for follow-up , is registered with Clinical Trials.gov , number NCT02039674 . FINDINGS Between Nov 25 , 2014 , and Jan 25 , 2016 , 123 patients were enrolled ; 60 were r and omly assigned to the pembrolizumab plus chemotherapy group and 63 to the chemotherapy alone group . 33 ( 55 % ; 95 % CI 42 - 68 ) of 60 patients in the pembrolizumab plus chemotherapy group achieved an objective response compared with 18 ( 29 % ; 18 - 41 ) of 63 patients in the chemotherapy alone group ( estimated treatment difference 26 % [ 95 % CI 9 - 42 % ] ; p=0·0016 ) . The incidence of grade 3 or worse treatment-related adverse events was similar between groups ( 23 [ 39 % ] of 59 patients in the pembrolizumab plus chemotherapy group and 16 [ 26 % ] of 62 in the chemotherapy alone group ) . The most common grade 3 or worse treatment-related adverse events in the pembrolizumab plus chemotherapy group were anaemia ( seven [ 12 % ] of 59 ) and decreased neutrophil count ( three [ 5 % ] ) ; an additional six events each occurred in two ( 3 % ) for acute kidney injury , decreased lymphocyte count , fatigue , neutropenia , and sepsis , and thrombocytopenia . In the chemotherapy alone group , the most common grade 3 or worse events were anaemia ( nine [ 15 % ] of 62 ) and decreased neutrophil count , pancytopenia , and thrombocytopenia ( two [ 3 % ] each ) . One ( 2 % ) of 59 patients in the pembrolizumab plus chemotherapy group experienced treatment-related death because of sepsis compared with two ( 3 % ) of 62 patients in the chemotherapy group : one because of sepsis and one because of pancytopenia . INTERPRETATION Combination of pembrolizumab , carboplatin , and pemetrexed could be an effective and tolerable first-line treatment option for patients with advanced non-squamous NSCLC . This finding is being further explored in an ongoing international , r and omised , double-blind , phase 3 study . FUNDING Merck & BACKGROUND Atezolizumab is a humanised antiprogrammed death-lig and 1 ( PD-L1 ) monoclonal antibody that inhibits PD-L1 and programmed death-1 ( PD-1 ) and PD-L1 and B7 - 1 interactions , reinvigorating anticancer immunity . We assessed its efficacy and safety versus docetaxel in previously treated patients with non-small-cell lung cancer . METHODS We did a r and omised , open-label , phase 3 trial ( OAK ) in 194 academic or community oncology centres in 31 countries . We enrolled patients who had squamous or non-squamous non-small-cell lung cancer , were 18 years or older , had measurable disease per Response Evaluation Criteria in Solid Tumors , and had an Eastern Cooperative Oncology Group performance status of 0 or 1 . Patients had received one to two previous cytotoxic chemotherapy regimens ( one or more platinum based combination therapies ) for stage IIIB or IV non-small-cell lung cancer . Patients with a history of autoimmune disease and those who had received previous treatments with docetaxel , CD137 agonists , anti-CTLA4 , or therapies targeting the PD-L1 and PD-1 pathway were excluded . Patients were r and omly assigned ( 1:1 ) to intravenously receive either atezolizumab 1200 mg or docetaxel 75 mg/m2 every 3 weeks by permuted block r and omisation ( block size of eight ) via an interactive voice or web response system . Co primary endpoints were overall survival in the intention-to-treat ( ITT ) and PD-L1-expression population TC1/2/3 or IC1/2/3 ( ≥1 % PD-L1 on tumour cells or tumour-infiltrating immune cells ) . The primary efficacy analysis was done in the first 850 of 1225 enrolled patients . This study is registered with Clinical Trials.gov , number NCT02008227 . FINDINGS Between March 11 , 2014 , and April 29 , 2015 , 1225 patients were recruited . In the primary population , 425 patients were r and omly assigned to receive atezolizumab and 425 patients were assigned to receive docetaxel . Overall survival was significantly longer with atezolizumab in the ITT and PD-L1-expression population s. In the ITT population , overall survival was improved with atezolizumab compared with docetaxel ( median overall survival was 13·8 months [ 95 % CI 11·8 - 15·7 ] vs 9·6 months [ 8·6 - 11·2 ] ; hazard ratio [ HR ] 0·73 [ 95 % CI 0·62 - 0·87 ] , p=0·0003 ) . Overall survival in the TC1/2/3 or IC1/2/3 population was improved with atezolizumab ( n=241 ) compared with docetaxel ( n=222 ; median overall survival was 15·7 months [ 95 % CI 12·6 - 18·0 ] with atezolizumab vs 10·3 months [ 8·8 - 12·0 ] with docetaxel ; HR 0·74 [ 95 % CI 0·58 - 0·93 ] ; p=0·0102 ) . Patients in the PD-L1 low or undetectable subgroup ( TC0 and IC0 ) also had improved survival with atezolizumab ( median overall survival 12·6 months vs 8·9 months ; HR 0·75 [ 95 % CI 0·59 - 0·96 ] ) . Overall survival improvement was similar in patients with squamous ( HR 0·73 [ 95 % CI 0·54 - 0·98 ] ; n=112 in the atezolizumab group and n=110 in the docetaxel group ) or non-squamous ( 0·73 [ 0·60 - 0·89 ] ; n=313 and n=315 ) histology . Fewer patients had treatment-related grade 3 or 4 adverse events with atezolizumab ( 90 [ 15 % ] of 609 patients ) versus docetaxel ( 247 [ 43 % ] of 578 patients ) . One treatment-related death from a respiratory tract infection was reported in the docetaxel group . INTERPRETATION To our knowledge , OAK is the first r and omised phase 3 study to report results of a PD-L1-targeted therapy , with atezolizumab treatment result ing in a clinical ly relevant improvement of overall survival versus docetaxel in previously treated non-small-cell lung cancer , regardless of PD-L1 expression or histology , with a favourable safety profile . FUNDING F. Hoffmann-La Roche Ltd , Genentech , Background The programmed death 1 ( PD‐1 ) inhibitor pembrolizumab has been found to prolong progression‐free and overall survival among patients with advanced melanoma . We conducted a phase 3 double‐blind trial to evaluate pembrolizumab as adjuvant therapy in patients with resected , high‐risk stage III melanoma . Methods Patients with completely resected stage III melanoma were r and omly assigned ( with stratification according to cancer stage and geographic region ) to receive 200 mg of pembrolizumab ( 514 patients ) or placebo ( 505 patients ) intravenously every 3 weeks for a total of 18 doses ( approximately 1 year ) or until disease recurrence or unacceptable toxic effects occurred . Recurrence‐free survival in the overall intention‐to‐treat population and in the subgroup of patients with cancer that was positive for the PD‐1 lig and ( PD‐L1 ) were the primary end points . Safety was also evaluated . Results At a median follow‐up of 15 months , pembrolizumab was associated with significantly longer recurrence‐free survival than placebo in the overall intention‐to‐treat population ( 1‐year rate of recurrence‐free survival , 75.4 % [ 95 % confidence interval { CI } , 71.3 to 78.9 ] vs. 61.0 % [ 95 % CI , 56.5 to 65.1 ] ; hazard ratio for recurrence or death , 0.57 ; 98.4 % CI , 0.43 to
Output:
| Compared with PD-L1 inhibitors , PD-1 inhibitors neither increased trAEs nor irAEs significantly .
Conclusions : Current data showed that PD-L1 inhibitors had the best safety on both trAEs and irAEs . |
MS212991 | ***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: The purpose of this study was to examine the impact of geriatric day care and homemaker services on patient outcomes . Patients were r and omly assigned to receive the experimental services in three study sample s. In comparing outcomes between the experimental and control groups , it was found that there were significant differences in physical functioning and activity level for the day care sample s , in physical functioning and contentment level for the homemaker study sample , and in all of these outcome measures for the combined services group . Among users of the experimental services , increased use of the services was associated with improved outcomes of care . Multivariate analysis of data showed that factors other than the use of the experimental services were more effective in explaining variation in outcomes . Significant factors that affected all four outcome measures in both the day care and homemaker study were primary diagnosis , impairment prognosis , and number of inpatient hospital days The effectiveness and cost of day hospital care in rehabilitation were studied in a r and omised controlled trial in 120 elderly patients who were assessed at referral and six weeks and five months later in activities of daily living skills and mood . Day hospital patients were compared with a control group , who were managed as they would have been before the availability of day hospital care . Day hospital patients showed a significant improvement in performance of activities of daily living at six weeks but not at five months ; however , they had a sustained improvement in mood . The cost of day hospital rehabilitation was one third greater than that of rehabilitation by alternative means . In its current form the geriatric day hospital is not a cheap alternative to other means of rehabilitation . Expensive components of the day hospital should be critically re-examined and renewed emphasis placed on sufficient inpatient beds , domiciliary services , and day care centres 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 Falls in older people are a major public health concern in terms of morbidity , mortality and cost . Previous studies suggest that multifactorial interventions can reduce falls , and many geriatric day hospitals are now offering falls intervention programmes . However , no studies have investigated whether these programmes , based in the day hospital are effective , nor whether they can be successfully applied to high-risk older people screened in primary care . The hypothesis is that a multidisciplinary falls assessment and intervention at Day hospitals can reduce the incidence of falls in older people identified within primary care as being at high risk of falling . This will be tested by a pragmatic parallel-group r and omised controlled trial in which the participants , identified as at high risk of falling , will be r and omised into either the intervention Day hospital arm or to a control ( current practice ) arm . Those participants preferring not to enter the full r and omised study will be offered the opportunity to complete brief diaries only at monthly intervals . This data will be used to vali date the screening question naire . Three day hospitals ( 2 Nottingham , 1 Derby ) will provide the interventions , and the University of Nottingham 's Departments of Primary Care , the Division of Rehabilitation and Ageing Unit , and the Trent Institute for Health Service Research will provide the method ological and statistical expertise . Four hundred subjects will be r and omised into the two arms . The primary outcome measure will be the rate of falls over one year . Secondary outcome measures will include the proportion of people experiencing at least one fall , the proportion of people experiencing recurrent falls ( > 1 ) , injuries , fear of falling , quality of life , institutionalisation rates , and use of health services . Cost-effectiveness analyses will be performed to inform health commissioners about re source allocation issues . The importance of this trial is that the results may be applicable to any UK day hospital setting .SitesGeneral practice s across Nottinghamshire and Derbyshire . Day hospitals : Derbyshire Royal Infirmary ( Southern Derbyshire Acute Hospitals NHS Trust)Sherwood Day Service ( Nottingham City Hospital Trust)Leengate Day Hospital ( Queen 's Medical Centre Nottingham University Hospital NHS Trust OBJECTIVE To assess the effectiveness of comprehensive geriatric assessment conducted in day hospitals . DESIGN Retrospective cohort comparison study with restricted inclusion ary criteria and adjustment for baseline characteristics . SETTING A hospital-based geriatric day hospital and geriatric clinic sites ( both in the university and in the community ) . PATIENTS Four hundred sixty-eight patients referred for comprehensive geriatric assessment during a 12-month period . INTERVENTION Comprehensive geriatric assessment in a geriatric day hospital compared with assessment received in clinic sites without a day hospital . MAIN OUTCOME MEASURES Services received in the first 2 weeks ; hospitalization , emergency room visits , placement , death , and change in selected health status measures . Follow-up data was obtained from medical records , a telephone survey , and death certificates . RESULTS Except in the case of rehabilitative services , day hospital patients were more likely to receive interdisciplinary services . The population seen in the day hospital was more functionally impaired and had significantly more dementia and depression . After adjusting for subjects ' baseline characteristics and limiting the analyses to subjects meeting specific inclusion ary criteria , the day hospital had no significant effect on mortality , use of emergency or hospital services , placement , or change on selected measures of health status . For example , compared with the clinic patients , receiving care in the day hospital was associated with an adjusted odds ratio of 1.01 ( 95 % confidence interval : 0.53 , 1.91 ) of being at a higher level of care at 6 months . The results were not sensitive to the choice of inclusion ary criteria . CONCLUSION Given their cost and uncertain effectiveness , day hospitals need additional evaluation before their further diffusion occurs OBJECTIVES To compare the effectiveness of Cooperative Health Care Clinic ( ( CHCC ) group outpatient model for chronically ill , older health maintenance organization ( HMO ) patients ) with usual care . DESIGN Two-year , r and omized , controlled trial conducted with recruitment from February 1995 through July of 1996 . SETTING Nonprofit group model HMO . PARTICIPANTS Two hundred ninety-four adults ( 145 intervention and 149 usual care ) , aged 60 and older ( mean age 74.1 ) with 11 or more outpatient visits in the prior 18 months , one or more self-reported chronic conditions , and expressed interest in participating in a group clinic . INTERVENTION Monthly group meetings held by patients ' primary care physicians . MEASUREMENT Differences in clinic visits , inpatient admissions , emergency room visits , hospital outpatient services , professional services , home health , and skilled nursing facility admissions ; measures of patient satisfaction , quality of life , self-efficacy , and activities of daily living ( ADLs ) . RESULTS Outpatient , pharmacy services , home health , and skilled nursing facility use did not differ between groups , but CHCC patients had fewer hospital admissions ( P=.012 ) , emergency visits ( P=.008 ) , and professional services ( P=.005 ) . CHCC patients ' costs were $ 41.80 per member per month less than those of control patients . CHCC patients reported higher satisfaction with their primary care physician ( P=.022 ) , better quality of life ( P=.002 ) , and greater self-efficacy ( P=.03 ) . Health status and ADLs did not differ between groups . CONCLUSION The CHCC model result ed in fewer hospitalizations and emergency visits , increased patient satisfaction , and self-efficacy , but no effect on outpatient use , health , or functional status OBJECTIVES To compare the effectiveness and costs of a new domiciliary rehabilitation service for elderly stroke patients with geriatric day-hospital care . DESIGN R and omized controlled trial . PARTICIPANTS Stroke patients aged 55 + who required further rehabilitation after hospital discharge or after referral to geriatricians from the community . SETTING Poole area , East Dorset , a mixed urban/rural area on the south coast of Engl and . MAIN OUTCOMES Primary -changes between hospital discharge and 6-month follow-up in physical function as measured by Barthel index . Secondary -changes over this period in Rivermead Mobility Index and mental state ( Philadelphia Geriatric Centre Morale Scale ) and differences in social activity ( Frenchay Activities Index ) and generic health status ( SF-36 ) . Health service and social service cost per patient were compared for the two groups . RESULTS 180 patients were eligible and 140 ( 78 % ) were r and omized . The groups were well balanced for age , sex , social class and initial Barthel index . We achieved follow-up in 88 % of subjects who were alive at 6 months . We detected no significant differences in patient outcomes , although there was a non-significant improvement in measures of physical function and social activity in the domiciliary group . Domiciliary patients had more physiotherapy time per session and more district nurse time , and made greater use of social service day centres and home helps . Total cost per patient did not differ significantly between the two groups , with reduced health service costs in the domiciliary arm offset by higher social service costs . CONCLUSION No significant differences were detected in the effectiveness of the two services . Neither service influenced patients ' mental state , and their social activity remained low . Total costs were similar . A mixed model of day-hospital and domiciliary care may be most cost-effective for community stroke rehabilitation , but this requires further evaluation This study compared the functional ability and perceived health status of stroke patients treated by a domiciliary rehabilitation team or by routine hospital-based services after discharge from hospital . Patients discharged from two acute and three rehabilitation hospitals in Nottingham were r and omly allocated in three strata ( Health Care of the Elderly , General Medical and Stroke Unit ) to receive domiciliary or hospital-based care after discharge . Functional recovery was assessed by the Extended Activities of Daily Living ( ADL ) scale three and six months after discharge and perceived health at six months was measured by the Nottingham Health Profile . A total of 327 eligible patients of 1119 on a register of acute stroke admissions were recruited over 16 months . Overall there were no differences between the groups in their Extended ADL scores at three or six months , or their Nottingham Health Profile scores at six months . In the Stroke Unit stratum , patients treated by the domiciliary team had higher household ( p = 0.02 ) and leisure activity ( p = 0.04 ) scores at six months than those receiving routine care . In the Health Care of the Elderly stratum , death or a move into long-term institutional care at six months occurred less frequently in patients allocated to the routine service , about half of whom attended a geriatric day hospital . Overall there was no difference in the effectiveness of the domiciliary and hospital-based services , although younger stroke unit patients appeared to do better with home therapy while some frail elderly patients might have benefited from day hospital attendance The DOMINO study ( DOMiciliary rehabilitation In NOttingham ) was a r and omized controlled trial comparing domiciliary and hospital-based rehabilitation for stroke patients after discharge from hospital , stratified according to the ward at hospital discharge . The outcomes of these patients have been reported previously . In this paper , we present estimates of health service costs of care . No difference in outcome had been found between the overall services , but we have found the hospital-based costs to be 27 % cheaper . However , different cost-effectiveness patterns are observable when the strata are analysed . Patients from geriatric wards had been shown to be 2.4 times less likely to die or become institutionalized by 6 months if allocated to a day hospital service , although the cost of this service was 25 % more than that of the domiciliary service . Patients from the Stroke Unit who had received domiciliary rehabilitation had been shown to have greater household and leisure abilities at 6 months than those treated in outpatient departments , but the domiciliary service was found to cost 2.6 times more . Patients from general medical wards had similar outcomes whether treated at home or in outpatient departments , but the cost of the latter service was 5
Output:
| These compared day hospital with a ) comprehensive elderly care ( five trials ) , b ) domiciliary care ( five trials ) , or c ) no comprehensive elderly care ( three trials).There were no significant differences between day hospital attendance and the sub-categories of comparison treatments for the outcomes of death , death or requiring institutional care , death or deterioration in ADL .
Using the outcome of deterioration in ADL among survivors , day hospital patients showed a reduced odds of deterioration when compared with those receiving no comprehensive elderly care ( OR 0.60 ; 95 % CI 0.38 to 0.97 ; P < 0.05).When re source use was examined the day hospital group showed trends towards reductions in hospital bed use and placement of survivors in institutional care .
Medical day hospital care for the elderly appears to be more effective than no intervention but may have no clear advantage over other forms of comprehensive elderly medical services |
MS212992 | ***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: One hundred patients who presented to the accident and emergency ( A&E ) department with an acute ankle sprain were entered into a study to determine the efficacy of topical ibuprofen cream by using a double-blind placebo controlled design in a single type of soft-tissue injury . The subjects were given either topical ibuprofen cream or a placebo cream in addition to the st and ard management of the department . Patients kept diaries recording walking ability and pain visual analogue scales for resting , st and ing and walking . A total of 51 patients returned diaries that were suitable for analysis . Patients using the topical ibuprofen cream had significant reduction in pain scores over the first 48 h of treatment Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size A double-blind , placebo-controlled , multi-centre study was carried out to assess the efficacy and tolerability of percutaneous niflumic acid gel in the treatment of uncomplicated ankle sprains . Sixty patients were enrolled in three centres and were r and omly allocated to receive treatment with 2.5 % percutaneous niflumic acid gel or placebo gel applied 3-times daily for 7 days . Clinical evaluations were made on entry to the study , after 3 days and at the end of treatment . The major efficacy criteria were the pain felt by the patient and the investigators ' and patients ' global evaluation of effectiveness of the treatment . Adverse events that occurred were also noted . The results showed that topically applied 2.5 % niflumic acid gel was superior to placebo in the treatment of ankle sprains in respect of all major parameters studied . Niflumic acid gel and the placebo were shown to be equally well tolerated . The study findings indicate that treatment with topical niflumic acid gel is effective in treating uncomplicated ankle sprains and results in improved clinical signs on Day 4 and after 7 days Topical anti-inflammatory management of superficial and deep phlebopathy with feprazone and benzidamine was compared in a double-blind test . Both drugs were active and well tolerated . Significantly less time was needed to obtain a cure with feprazone Objectives : To investigate the clinical efficacy and safety of a newly developed diclofenac patch in the topical treatment of blunt impact injuries . Methods : This was a r and omised , placebo controlled , double blind , multicentre study in 120 patients with traumatic blunt soft tissue injury . Within 3 h of the injury participants of sport competitions and training camps were enrolled and treated twice daily with the diclofenac or a placebo patch over a period of 7 days . Patients were r and omised ( 1:1 ) to two parallel groups . Tenderness produced by pressure was measured twice daily during the first 3 days after enrolment as well as at day 7 . Tenderness was defined as the amount of pressure ( measured by a calibrated caliper at the centre of the injury ) that first produced a pain reaction as reported by the patient . Results : The primary efficacy variable was the area under the curve for tenderness over the first 3 days . The diclofenac patch was significantly more effective than placebo ( p<0.0001 ) . The treatment effect was 64.7 kp h/cm2 ( 95 % confidence interval 48.7 to 80.9 ) between diclofenac and placebo patches . These results were supported by all secondary efficacy variables . The diclofenac patch produced rapid pain relief as reflected by the time to reach resolution of pain at the injured site which was significantly shorter compared to placebo ( p<0.0001 ) . The diclofenac patch was well tolerated . The most frequently observed adverse events were local cutaneous adverse reactions ( pruritus , rash ) of minor severity occurring with the same frequency as in the placebo group . Conclusions : A newly developed diclofenac patch is effective and safe for the treatment of blunt impact injuries Introduction Gastrointestinal upset and local pain commonly limit the use of oral nonsteroidal anti-inflammatory drugs and corticosteroid injection as treatments for lateral epicondylitis . Transdermal administration of an anti-inflammatory drug could avoid these adverse effects . Purpose To determine the effectiveness of topical diclofenac as a treatment of lateral epicondylitis . Methods A convenience sample of 14 subjects meeting clinical criteria of chronic lateral epicondylitis participated in this r and omized , double blind , crossover study . Each subject applied a plutonic lecithin liposomal organo-gel ( PLO ) over the affected lateral elbow three times daily for 1 week , followed by a 1-week “ washout ” period of no gel . A second topical PLO gel was then applied similarly for 1 week . Both gels were identical , but only one gel contained 2 % diclofenac . Treatment order was r and omized , and both the subject and tester were blinded . Pain and isometric wrist extension strength were measured using a visual analog pain scale ( VAS ) and a mounted manual muscle testing dynamometer , respectively , at the following time periods : just before application of the first gel , the last day of using the first gel , the last day of the washout week , and the last day of using the second gel . Analysis was performed using repeated measures analysis of variance . Results When subjects used diclofenac PLO , pain was significantly less than that during the pretreatment , washout , and placebo PLO periods ( mean VAS ; diclofenac PLO , 2.1 ; pretreatment , 3.5 ; washout , 3.4 ; placebo PLO , 3.6 ) . Average wrist extension strength was significantly greater when subjects used diclofenac PLO ( 8.4 kg ) than it was before treatment ( 5.9 kg ) . One subject developed a local rash while using diclofenac PLO . Conclusion Topical 2 % diclofenac in PLO appears to provide effective short-term reduction in elbow pain and wrist extensor weakness associated with chronic lateral epicondylitis A double-blind study vs placebo was carried out on 82 pts suffering from soft tissue trauma , to evaluate the efficacy and tolerance of a new anti-inflammatory , non-steroidal analgesic for topical use , 3 % BPAA . Clinical results obtained by the group treated with BPAA gel were highly significant ( p = 0.01 ) and positive , showing absence of local and systemic side-effects . Accordingly , BPAA gel can be recommended for treatment of soft tissue trauma One hundred and thirty-one male and female out patients , aged 18 - 70 yr , with acute pain in the ankle joint caused by a post-traumatic sprain , entered a multicentre , r and omised , double-blind , parallel-group , study . The patients were assigned to a 40 mg flurbiprofen patch ( n = 65 ) or a non-medicated ( but otherwise identical ) control ( n = 66 ) , 12-hourly over 7 days , and were assessed at entry and after 3 and 7 days treatment . On day 7 , spontaneous pain ( the prime efficacy parameter ) , as evaluated by the patient on a visual analogue scale in the physician 's office , showed significant improvement in the 40 mg flurbiprofen patch group compared to control ( change from baseline ) ( p = 0.039 ) , a result corroborated by the evaluation of the periarticular oedema : a reduction of 77.4 % was observed in the 40 mg flurbiprofen patch group , compared with 63.8 % in the control group ( p = 0.025 ) . The other selected efficacy criteria showed changes with a trend in favour of the 40 mg flurbiprofen patch but without statistical significance . Two mild and local adverse events were reported by two flurbiprofen patch patients , but neither patients discontinued the treatment prematurely . Physicians and patients found the flurbiprofen patch to be efficacious and well tolerated . Compliance was excellent in both groups . The efficacy and tolerability of the 40 mg flurbiprofen patch are therefore confirmed in the treatment of acute ankle sprains Abstract Objective : To determine whether inappropriate subgroup analysis together with chance could change the conclusion of a systematic review of several r and omised trials of an ineffective treatment . Design : 44 r and omised controlled trials of DICE therapy for stroke were performed ( simulated by rolling different coloured dice ; two trials per investigator ) . Each roll of the dice yielded the outcome ( death or survival ) for that “ patient . ” Publication bias was also simulated . The results were combined in a systematic review . Setting : Edinburgh . Main outcome measure — Mortality . Results : The “ hypothesis generating ” trial suggested that DICE therapy provided complete protection against death from acute stroke . However , analysis of all the trials suggested a reduction of only 11 % ( SD 11 ) in the odds of death . A predefined subgroup analysis by colour of dice suggested that red dice therapy increased the odds by 9 % ( 22 ) . If the analysis excluded red dice trials and those of poor method ological quality the odds decreased by 22 % ( 13 , 2P=0.09 ) . Analysis of “ published ” trials showed a decrease of 23 % ( 13 , 2P=0.07 ) while analysis of only those in which the trialist had become familiar with the intervention showed a decrease of 39 % ( 17 , 2P=0.02 ) . Conclusion : The early benefits of DICE therapy were not confirmed by subsequent trials . A plausible ( but inappropriate ) subset analysis of the effects of treatment led to the qualitatively different conclusion that DICE therapy reduced mortality , whereas in truth it was ineffective . Chance influences the outcome of clinical trials and systematic review s of trials much more than many investigators realise , and its effects may lead to incorrect conclusions about the benefits of treatment Anecdotally many athletes use non-steroidal anti-inflammatory gels during competition to allow continued participation . To determine if this clinical practice is useful a r and omised placebo-controlled study was conducted at the 5-day 2004 Red Cross Murray River Marathon . Forty-two kayakers presented with wrist extensor tenosynovitis while competing in the single and double kayak events . All subjects received st and ard treatment of ice , stretches and massage for wrist tenosynovitis before being r and omised into a placebo or 1 % diclofenac gel group . Evaluation was done by using a visual analogue scale ( 0 - 10 ) for pain and by clinical grading ( 0 - 3 ) . The main outcome measurements were reduction in pain and clinical grading , the requirement for a rescue medication ( paracetamol or diclofenac tablets ) and effect on performance times . Both groups had similar pain scores and clinical grading on the first and fifth days of pain . On the second to fourth days of pain there was clearly no benefit and possibly a detrimental effect on pain with diclofenac gel relative to placebo . However , diclofenac tablets were possibly beneficial for pain relative to paracetamol tablets . The effects of pain and the various treatments on performance time were either trivial ( < 0.5 % ) or small , but none was particularly clear . We conclude that st and ard treatment appears to be sufficient for the management of wrist extensor tenosynovitis during competition To evaluate the efficacy and tolerability of the new diclofenac-N-(2-hydroxyethyl)-pyrrolidine lecithin gel ( DHEP lecithin gel , with 1.3 % DHEP and 2.4 % lecithin ) compared with the efficacy and tolerability of diclofenac-N-(2-hydroxyethyl)-pyrrolidine gel ( DHEP gel ) in peri and extraarticular inflammatory states , a controlled , r and omized , double-blind clinical study was conducted . Two groups of 50 patients each were enrolled and were given one of the two different formulations with a slight massage on the painful area three times a day for 10 consecutive days . Patients received a self-evaluation notebook in which to record daily assessment of spontaneous pain ( Huskisson 's visual analogue scale ) . On days 0 , 3 and 10 , the patients were visited by the investig
Output:
| Topical diclofenac , ibuprofen , ketoprofen , and piroxicam were of similar efficacy , but indomethacin and benzydamine were not significantly better than placebo .
Local skin reactions were generally mild and transient , and did not differ from placebo .
There were very few systemic adverse events or withdrawals due to adverse events .
Topical NSAIDs can provide good levels of pain relief , without the systemic adverse events associated with oral NSAIDs , when used to treat acute musculoskeletal conditions |
MS212993 | ***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 Anemia and malnutrition are significant complications in peritoneal dialysis ( PD ) patients . Previous studies in hemodialysis have shown that and rogens are effective as therapy for anemia ; however , this has not been tested in a r and omized prospect i ve trial in PD patients . Furthermore , the anabolic properties of and rogens may exert additional benefits on the nutritional status in this population . METHODS Twenty-seven stable male patients over 50 years who were under maintenance continuous ambulatory peritoneal dialysis ( CAPD ) therapy were r and omized to receive recombinant human erythropoietin ( rHuEPO ; N = 14 ) or n and rolone decanoate ( ND ; 200 mg/week IM ; N = 13 ) as therapy for anemia . The evolution of hematologic parameters and the impact on both nutritional anthropometric and biochemical variables were evaluated after six months of treatment . RESULTS Hemoglobin and hematocrit experienced similar increases in both groups : from 8.5 + /- 0.9 g/dL and 25.8 + /- 2.7 % to 11.7 + /- 0.6 g/dL and 34.7 + /- 1.6 % ( P < 0.001 ) in patients receiving rHuEPO , and from 8.9 + /- 0.8 and 27 + /- 2.2 % to 11.8 + /- 0.4 g/dL and 35.1 + /- 1.5 % ( P < 0.001 ) in subjects treated with ND . At the end of the study , out of the diverse nutritional variables included in this investigation , only weight and body mass index significantly increased in the rHuEPO group . Conversely , both anthropometric [ weight , body mass index , triceps skinfold , mid-arm circumference ( MAC ) and mid-arm muscle circumference ( MAMC ) ] and biochemical parameters ( serum total proteins , albumin , prealbumin and transferrin ) were significantly increased in patients treated with ND . In this group , serum urea nitrogen , urea net excretion and protein equivalent of nitrogen appearance significantly decreased . These facts , together with an increase in serum creatinine and no changes in dietary intake during the study , suggest a rise in muscle mass related to an anabolic effect of n and rolone decanoate . Interestingly , serum levels of insulin-like growth factor type 1 ( IGF-1 ) increased in patients on the and rogen group compared to subjects treated with rHuEPO . Moreover , there was a positive and significant correlation between the rise in IGF-1 concentrations and the increase in hemoglobin , hematocrit , MAC and MAMC . CONCLUSIONS And rogens therapy improved the anemia in elderly male CAPD patients in a similar manner to that observed with rHuEPO . Furthermore , compared with rHuEPO , and rogen administration was associated with beneficial effects on nutritional status . The mechanism of action of and rogens on hematologic and nutritional parameters might be mediated , at least in part , by IGF-1 AIM To evaluate the effects of a protein-rich liquid supplementation , alone or in combination with the anabolic steroid n and rolone decanoate , on body composition , activities of daily living ( ADL ) status and the health-related quality of life ( HRQoL ) after a femoral neck fracture . METHODS Sixty women , aged 83 + /- 5 years ( mean + /- SD ) , BMI < 24 kg/m2 ( 20.4 + /- 2 kg/m2 ) and capable of co-operating , with a femoral neck fracture treated with internal fixation , were r and omised to open treatment during 6 months with a protein-rich liquid formula alone ( PR , Fortimel , 200 ml/day , 20 g protein/day ) or in combination with n and rolone decanoate ( PR/N , Deca-Durabol 25 mg i.m./3 weeks ) or to a control group ( C ) . The patients were re-examined after 6 and 12 months regarding body weight ( BW ) , lean body mass ( LBM , DXA ) , ADL status according to Katz , HRQoL according to EQ 5-D and fracture healing . RESULTS LBM decreased in the C ( -1.2 + /- 2 kg ) and PR groups ( -1.2 + /- 1 kg ) but remained the same in the PR/N group ( 0.3 + /- 1 kg ) ( P < 0.05 between groups ) . ADL remained at a high level in the two intervention groups but declined significantly in the C group ( P < 0.005 between groups ) . The decline in HRQoL was least pronounced in the PR/N group at 6 months ( P < 0.05 between groups ) . Patients with fracture healing complications lost more BW ( P < 0.05 ) and LBM ( P < 0.01 ) than patients with uneventful fracture healing . CONCLUSION Protein-rich liquid supplementation in combination with n and rolone given for 6 months to lean elderly women after a femoral neck fracture may positively affect LBM , ADL and 59 elderly patients ( mean age 82 ) with femoral neck fractures were r and omised into two groups . 27 patients received daily an oral nutrition supplement ( 250 ml , 20 g protein , 254 kcal ) for a mean of 32 days ; 32 patients acted as controls . On admission most patients had nutritional deficiencies . Despite being offered adequate quantities , nutritional requirements were not met during the hospital stay . Clinical outcome was significantly better in the supplemented group ( 56 % favourable course vs 13 % in controls ) during the stay in the convalescent hospital . The rates of complications and deaths were also significantly lower in supplemented patients ( 44 % vs 87 % ) . 6 months after the fracture the rates of complications and mortality were significantly lower in supplemented patients ( 40 % vs 74 % ) . The median duration of hospital stay was significantly shorter in the supplemented group ( 24 vs 40 days ) . Thus the clinical outcome of elderly patients with femoral neck fracture can be improved by once daily dietary oral supplementation A total of 63 women who had an operation for a fracture of the hip was r and omly allocated to one year of treatment either with anabolic steroids , vitamin D and calcium ( anabolic group ) or with calcium only ( control group ) . The thigh muscle volume was measured by quantitative CT . The bone mineral density of the hip , femur and tibia was assessed by quantitative CT and dual-energy x-ray absorptiometry and of the heel by quantitative ultrasound . Quantitative CT showed that the anabolic group did not lose muscle volume during the first 12 months whereas the control group did ( p<0.01 ) . There was less bone loss in the proximal tibia in the anabolic group than in the control group . The speed of gait and the Harris hip score were significantly better in the anabolic group after six and 12 months . Anabolic steroids , even in this moderate dose , given in combination with vitamin D and calcium had a beneficial effect on muscle volume , bone mineral density and clinical function in this group of elderly women Objective : To evaluate ox and rolone , an oral anabolic steroid with potent anabolic activity and minimal and rogenic effects , for the treatment of AIDS‐associated myopathy and wasting . Methods : In a multicenter , double‐blind study , 63 HIV‐seropositive men with > 10 % loss of body weight were r and omized to receive either placebo , 5 mg/day ox and rolone , or 15 mg/day ox and rolone for 16 weeks . Body weight , neuromuscular evaluation , and measures of well‐being were repeatedly assessed . Results : Patients who received 15 mg/day ox and rolone showed weight gain throughout the 16‐week treatment period . Overall , the 5 mg/day ox and rolone group maintained their weight gain over the 16‐week period , whereas the placebo group showed continual weight loss . At week 16 , significantly more patients in the 15 mg/day dose group reported increases in appetite and activity than those receiving placebo . There were no consistent , dose related , statistically significant differences from baseline in laboratory values or adverse events . Conclusion : Ox and rolone , at a dose of either 5 mg/day or 15 mg/day , in contrast to placebo , had a positive impact on the weight and well‐being of HIV‐seropositive patients suffering from wasting and weakness . Measurable improvement in muscle strength was not noted at the doses employed in this study . Ox and rolone was well tolerated in all the patients who were enrolled in the study Based on the results reported here , additional studies using higher doses of ox and rolone seem warranted Abstract As the world population ages , the prevalence of osteoporosis and the incidence of hip fractures will increase dramatically , being responsible for an increase of the health expenditure . On the other h and , there is the inescapable fact of scarcity creating the necessity of making difficult choices with regard to the allocation of human re sources . So the question remains : should we carry on investing an important part of our health expenditure for the treatment of hip fractures in elderly people ? To answer this statement , we compared 384 hip fracture patients of 70 years and older treated in our department between 1978 and 1983 with 1102 patients treated between 1998 and 2003 . Both groups had a prospect i ve follow-up of at least one year . There were no statistically significant differences : mortality rate 24 % vs. 23 % ; good functional outcome 82 % vs. 73 % ; and home going rate 60 % vs. 66 % . The factors influencing these results were studied . So we can conclude : -The number of hip fractures treated nowadays has increased compared with twenty years ago ; -There is no significant improvement in mortality , nor in quality of life ; -Age is not a contraindication for hip fracture surgery BACKGROUND We examined the effects of hip fracture on mortality , entry into long-term institutional care , and new evidence of poverty . We estimate of the proportion of hip fracture patients who require not just short-term rehabilitation but who become dependent on long-term institutional care , and the risk of becoming newly dependent on Medicaid or eligible for low-income subsidies following hip fracture . METHODS We used data from 2005 through 2010 for a r and om 5 % sample of Medicare beneficiaries ( N = 3.1 million ) to conduct a retrospective matched cohort study . We used high-dimensional propensity score matching to compare outcomes for patients who experienced a hip fracture with subjects who did not , but had similar propensity for suffering a hip fracture . We then compared the 1-year risk of death , debility , and destitution between groups . RESULTS We matched 43,210 hip fracture patients to comparators without a hip fracture . Hip fractures were associated with more than a twofold increase in likelihood of mortality ( incidence proportion ratio [ IPR ] of 2.27 , 95 % CI , 2.20 - 2.34 ) , a fourfold increase in likelihood of requiring long-term nursing facility care ( IPR , 3.96 ; 95 % CI , 3.77 - 4.16 ) , and a twofold increase in the probability of entering into low-income status ( IPR , 2.14 ; 95 % CI 1.99 - 2.31 ) within 1 year following hip fracture compared with subjects without a hip fracture . CONCLUSIONS Hip fracture in elderly patients result ed in increased death , debility , and destitution . Initiatives that lead to improved treatment of osteoporosis could result in a decrease in incidence of fractures , subsequent death , debility , and destitution for older adults Background Hip fractures in the elderly are followed by considerable risk of functional decline and mortality . Questions / purpose sThe purpose s of this study were to ( 1 ) explore predictive factors of functional level at discharge , ( 2 ) evaluate 1-year mortality after hip fracture compared with that of the general population , and ( 3 ) evaluate the affect of early functional outcome on 1-year mortality in patients operated on for hip fractures . Methods A total of 228 consecutive patients ( average age , 77.6 ± 7.4 years ) with hip fractures who met the inclusion criteria were enrolled in an open , prospect i ve , observational cohort study . Functional level at discharge was measured with the motor Functional Independence Measure ( FIM ) score , which is the most widely accepted functional assessment measure in use in the rehabilitation community . Mortality rates in the study population were calculated in absolute numbers and as the st and ardized mortality ratio . Multivariate regression analysis was used to explore predictive factors for motor FIM score at discharge and for 1-year mortality adjusted for important baseline variables . Results Age , health status , cognitive level , preinjury functional level , and pressure sores after hip fracture surgery were independently related to lower discharge motor FIM scores . At 1-year followup , 57 patients ( 25 % ; 43 women and 14 men ) had died . The 1-year hip fracture mortality rate compared with that of the general population was 31 % in our population versus 7 % for men and 23 % in our population versus 5 % for women 65 years or older . The 1-year st and ardized mortality rate was 341.3 ( 95 % CI , 162.5–520.1 ) for men and 301.6 ( 95 % CI , 212.4–391.8 ) for women , respectively . The all-
Output:
| The available evidence is insufficient to draw conclusions on the effects , primarily in terms of functional outcome and adverse events , of anabolic steroids , either separately or in combination with nutritional supplements , after surgical treatment of hip fracture in older people . |
MS212994 | ***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: Carbohydrate metabolism was assessed in 20 glucose-intolerant subjects before and after 12 wk on a high-carbohydrate diet ( HC ) or the diet combined with exercise training ( HC-EX ) . The diet provided 60 % of energy as carbohydrate and 20 % as fat . Neither treatment altered fasting glucose or insulin concentrations or their response to a meal . During a glucose clamp ( 216 pmol insulin/L ) glucose disposal increased from 13.2 + /- 0.83 to 14.6 + /- 0.83 mumol.kg fat-free mass-1.min-1 ( P < 0.05 ) in both groups . During more pronounced hyperinsulinemia ( 654 pmol/L ) glucose disposal did not change significantly ( 49.9 + /- 3.8 to 50.7 + /- 3.8 mumol.kg fat-free mass-1.min-1 ) . Muscle glycogen increased in the HC-EX group ( 78.5 + /- 8.1 to 161.1 + /- 15.7 mmol glucose/kg muscle ) , with no changes in the HC group . These results do not support the recommendation to increase the dietary carbohydrate content for improving postpr and ial glucose metabolism or insulin action in glucose-intolerant adults unless combined with exercise training , which promotes muscle glycogen storage Circulating adiponectin is reduced in disorders associated with insulin resistance . This study was conducted to determine whether an exercise/diet intervention would alter adiponectin multimer distribution and adiponectin receptor expression in skeletal muscle . Impaired glucose-tolerant older ( > 60 yr ) obese ( BMI 30 - 40 kg/m(2 ) ) men ( n = 7 ) and women ( n = 14 ) were r and omly assigned to 12 wk of supervised aerobic exercise combined with either a hypocaloric ( ExHypo , approximately 500 kcal reduction , n = 11 ) or eucaloric diet ( ExEu , n = 10 ) . Insulin sensitivity was determined by the euglycemic ( 5.0 mM ) hyperinsulinemic ( 40 mU x m(-2 ) x min(-1 ) ) clamp . Adiponectin multimers [ high ( HMW ) , middle ( MMW ) , and low molecular weight ( LMW ) ] were measured by nondenaturing Western blot analysis . Relative quantification of adiponectin receptor expression through RT-PCR was determined from skeletal muscle biopsy sample s. Greater weight loss occurred in ExHypo compared with ExEu subjects ( 8.0 + /- 0.6 vs. 3.2 + /- 0.6 % , P < 0.0001 ) . Insulin sensitivity improved postintervention in both groups ( ExHypo : 2.5 + /- 0.3 vs. 4.4 + /- 0.5 mg x kg FFM(-1 ) x min(-1 ) , and ExEu : 2.9 + /- 0.4 vs. 4.1 + /- 0.4 mg x kg FFM(-1 ) x min(-1 ) , P < 0.0001 ) . Comparison of multimer isoforms revealed a decreased percentage in MMW relative to HMW and LMW ( P < 0.03 ) . The adiponectin SA ratio ( HMW/total ) was increased following both interventions ( P < 0.05 ) and correlated with the percent change in insulin sensitivity ( P < 0.03 ) . Postintervention adiponectin receptor mRNA expression was also significantly increased ( AdipoR1 P < 0.03 , AdipoR2 P < 0.02 ) . These data suggest that part of the improvement in insulin sensitivity following exercise and diet may be due to changes in the adiponectin oligomeric distribution and enhanced membrane receptor expression To evaluate the effects of endurance training on the expression of monocarboxylate transporters ( MCT ) in human vastus lateralis muscle , we compared the amounts of MCT1 and MCT4 in total muscle preparations ( MU ) and sarcolemma-enriched ( SL ) and mitochondria-enriched ( MI ) fractions before and after training . To determine if changes in muscle lactate release and oxidation were associated with training-induced changes in MCT expression , we correlated b and densities in Western blots to lactate kinetics determined in vivo . Nine weeks of leg cycle endurance training [ 75 % peak oxygen consumption ( VO(2 peak ) ) ] increased muscle citrate synthase activity ( + 75 % , P < 0.05 ) and percentage of type I myosin heavy chain ( + 50 % , P < 0.05 ) ; percentage of MU lactate dehydrogenase-5 ( M4 ) isozyme decreased ( -12 % , P < 0.05 ) . MCT1 was detected in SL and MI fractions , and MCT4 was localized to the SL . Muscle MCT1 contents were consistent among subjects both before and after training ; in contrast , MCT4 contents showed large interindividual variations . MCT1 amounts significantly increased in MU , SL , and MI after training ( + 90 % , + 60 % , and + 78 % , respectively ) , whereas SL but not MU MCT4 content increased after training ( + 47 % , P < 0.05 ) . Mitochondrial MCT1 content was negatively correlated to net leg lactate release at rest ( r = -0.85 , P < 0.02 ) . Sarcolemmal MCT1 and MCT4 contents correlated positively to net leg lactate release at 5 min of exercise at 65 % VO(2 peak ) ( r = 0.76 , P < 0.03 and r = 0 . 86 , P < 0.01 , respectively ) . Results support the conclusions that 1 ) endurance training increases expression of MCT1 in muscle because of insertion of MCT1 into both sarcolemmal and mitochondrial membranes , 2 ) training has variable effects on sarcolemmal MCT4 , and 3 ) both MCT1 and MCT4 participate in the cell-cell lactate shuttle , whereas MCT1 facilitates operation of the intracellular lactate shuttle OBJECTIVE To determine the efficacy of high-intensity progressive resistance training ( PRT ) on glycemic control in older adults with type 2 diabetes . RESEARCH DESIGN AND METHODS We performed a 16-week r and omized controlled trial in 62 Latino older adults ( 40 women and 22 men ; mean + /- SE age 66 + /- 8 years ) with type 2 diabetes r and omly assigned to supervised PRT or a control group . Glycemic control , metabolic syndrome abnormalities , body composition , and muscle glycogen stores were determined before and after the intervention . RESULTS Sixteen weeks of PRT ( three times per week ) result ed in reduced plasma glycosylated hemoglobin levels ( from 8.7 + /- 0.3 to 7.6 + /- 0.2 % ) , increased muscle glycogen stores ( from 60.3 + /- 3.9 to 79.1 + /- 5.0 mmol glucose/kg muscle ) , and reduced the dose of prescribed diabetes medication in 72 % of exercisers compared with the control group , P = 0.004 - 0.05 . Control subjects showed no change in glycosylated hemoglobin , a reduction in muscle glycogen ( from 61.4 + /- 7.7 to 47.2 + /- 6.7 mmol glucose/kg muscle ) , and a 42 % increase in diabetes medications . PRT subjects versus control subjects also increased lean mass ( + 1.2 + /- 0.2 vs. -0.1 + /- 0.1 kg ) , reduced systolic blood pressure ( -9.7 + /- 1.6 vs. + 7.7 + /- 1.9 mmHg ) , and decreased trunk fat mass ( -0.7 + /- 0.1 vs. + 0.8 + /- 0.1 kg ; P = 0.01 - 0.05 ) . CONCLUSIONS PRT as an adjunct to st and ard of care is feasible and effective in improving glycemic control and some of the abnormalities associated with the metabolic syndrome among high-risk older adults with type 2 diabetes Hispanics are at increased risk of morbidity and mortality due to their high prevalence of diabetes and poor glycemic control . Strength training is the most effective lifestyle intervention to increase muscle mass but limited data is available in older adults with diabetes . We determined the influence of strength training on muscle quality ( strength per unit of muscle mass ) , skeletal muscle fiber hypertrophy , and metabolic control including insulin resistance ( Homeostasis Model Assessment –HOMA-IR ) , C-Reactive Protein ( CRP ) , adiponectin and Free Fatty Acid ( FFA ) levels in Hispanic older adults . Sixty-two community-dwelling Hispanics ( > 55 y ) with type 2 diabetes were r and omized to 16 weeks of strength training plus st and ard care ( ST group ) or st and ard care alone ( CON group ) . Skeletal muscle biopsies and biochemical measures were taken at baseline and 16 weeks . The ST group show improved muscle quality ( mean±SE : 28±3 ) vs CON ( -4±2 , p<0.001 ) and increased type I ( 860±252µm2 ) and type II fiber cross-sectional area ( 720±285µm2 ) compared to CON ( type I : -164±290µm2 , p=0.04 ; and type II : -130±336µm2 , p=0.04 ) . This was accompanied by reduced insulin resistance [ ST : median ( interquartile range ) -0.7(3.6 ) vs CON : 0.8(3.8 ) , p=0.05 ] ; FFA ( ST : -84±30µmol/L vs CON : 149±48µmol/L , p=0.02 ) ; and CRP [ ST : -1.3(2.9)mg/L vs CON : 0.4(2.3)mg/L , p=0.05 ] . Serum adiponectin increased with ST [ 1.0(1.8)µg/mL ] compared to CON [ -1.2(2.2)µg/mL , p<0.001 ] . Strength training improved muscle quality and whole-body insulin sensitivity . Decreased inflammation and increased adiponectin levels were related with improved metabolic control . Further studies are needed to underst and the mechanisms associated with these findings . However , these data show that strength training is an exercise modality to consider as an adjunct of st and ard of care in high risk population s with type 2 diabetes We examined the expression of the sodium-dependent glucose co-transporter system ( hSGLT3 ) in skeletal muscle of Hispanic older adults with type 2 diabetes . Subjects ( 65±8 yr ) were r and omized to resistance training ( 3x/wk , n=13 ) or st and ard of care ( controls , n=5 ) for 16 weeks . Skeletal muscle hSGLT3 and GLUT4 mRNA transcript levels were determined by real time RT-PCR . hSGLT3 transcripts increased by a factor of ten following resistance training compared to control subjects ( 0.10 , P=0.03 ) . There were no differences in GLUT4 mRNA expression levels between groups . Protein expression levels of these transporters were confirmed by immunohistochemistry and Western blotting . hSGLT3 after resistance exercise was found not to be co-localized with the nicotinic acetylcholine receptor . The change in hSGLT3 transcript levels in the vastus lateralis muscle was positively correlated with glucose uptake , as measured by the change in muscle glycogen stores ( r=0.53 , P=0.02 ) ; and with exercise intensity , as measured by the change in muscle strength ( r=0.73 , P=0.001 ) . Group assignment was be the only independent predictor of hSGLT3 transcript levels , explaining 68 % of its variability ( P=0.01 ) . Our data show that hSGLT3 , but not GLTU4 , expression was enhanced in skeletal muscle after 16 weeks of resistance training . This finding suggests that hSGLT3 , an insulin-independent glucose transporter , is activated with exercise and it may play a significant role in glycemic control with muscle contraction . The hSGLT3 exact mechanism is not well understood and requires further investigation . However its functional significance regarding a reduction of glucose toxicity and improvement of insulin resistance is the subject of ongoing research OBJECTIVE To determine the feasibility and the benefits of combined resistance and interval exercise training on phenotype characteristics and skeletal muscle function in deconditioned , type 2 diabetes ( T2D ) patients with polyneuropathy . DESIGN Short-term , single-arm intervention trial . METHODS Eleven male T2D patients ( age : 59.1+/-7.5 years ; body mass index : 32.2+/-4.0 kg/m2 ) performed progressive resistance and interval exercise training thrice a week for 10 weeks . Besides primary diabetes outcome measures , muscle strength ( MUST ) , maximal workload capacity
Output:
| Beneficial adaptations to exercise were seen primarily in muscle fiber area and capillary density , glycogen , glycogen synthase and GLUT4 protein expressions . |
MS212995 | ***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 oxygen uptake efficiency slope ( OUES ) is a submaximal index incorporating cardiovascular , peripheral , and pulmonary factors that determine the ventilatory response to exercise . The purpose of this study was to evaluate the effects of continuous exercise training and interval exercise training on the OUES in patients with coronary artery disease . Thirty-five patients ( 59.3±1.8 years old ; 28 men , 7 women ) with coronary artery disease were r and omly divided into two groups : continuous exercise training ( n=18 ) and interval exercise training ( n=17 ) . All patients performed grade d exercise tests with respiratory gas analysis before and 3 months after the exercise-training program to determine ventilatory anaerobic threshold ( VAT ) , respiratory compensation point , and peak oxygen consumption ( peak VO2 ) . The OUES was assessed based on data from the second minute of exercise until exhaustion by calculating the slope of the linear relation between oxygen uptake and the logarithm of total ventilation . After the interventions , both groups showed increased aerobic fitness ( P<0.05 ) . In addition , both the continuous exercise and interval exercise training groups demonstrated an increase in OUES ( P<0.05 ) . Significant associations were observed in both groups : 1 ) continuous exercise training ( OUES and peak VO2 r=0.57 ; OUES and VO2 VAT r=0.57 ) ; 2 ) interval exercise training ( OUES and peak VO2 r=0.80 ; OUES and VO2 VAT r=0.67 ) . Continuous and interval exercise training result ed in a similar increase in OUES among patients with coronary artery disease . These findings suggest that improvements in OUES among CAD patients after aerobic exercise training may be dependent on peripheral and central mechanisms Objective . To study the effect of aerobic treadmill exercise training with different intensity on left ventricular ( LV ) function in patients with stable coronary artery disease , using Strain Rate- and Tissue Doppler Imaging . Design . Seventeen patients were r and omly assigned to either moderate ( 50–60 % of peak oxygen uptake ( VO2peak ) ) or high intensity exercise ( 80–90 % of VO2peak ) for 10 weeks . Results . The increase of VO2peak was significantly higher ( p=0.01 ) in the high intensity group ( 17 vs. 8 % ) . Mean LV early diastolic strain rate increased in the high , but not in the moderate , intensity group . For systolic strain rate or mitral annular velocities there were no change after training in either group . Conclusions . Aerobic treadmill exercise improves early diastolic relaxation in patients with stable coronary artery disease , measured by the mean LV early diastolic strain rate BACKGROUND Peak oxygen uptake ( Vo(2peak ) ) strongly predicts mortality in cardiac patients . We compared the effects of aerobic interval training ( AIT ) versus moderate continuous training ( MCT ) on Vo(2peak ) and quality of life after coronary artery bypass grafting ( CABG ) . METHODS Fifty-nine CABG patients were r and omized to either AIT at 90 % of maximum heart rate or MCT at 70 % of maximum heart rate , 5 d/wk , for 4 weeks at a rehabilitation center . Primary outcome was Vo(2peak ) , at baseline , after rehabilitation ( 4 weeks ) , and after 6 months of home-based exercise ( 6 months ) . RESULTS Vo(2peak ) increased between baseline and 4 weeks in AIT ( 27.1 + /- 4.5 vs 30.4 + /- 5.5 mL.kg(-1).min(-1 ) , P < .001 ) and MCT ( 26.2 + /- 5.2 vs 28.5 + /- 5.6 mL.kg(-1).min(-1 ) , P < .001 ; group difference , not significant ) . Aerobic interval training increased Vo(2peak ) between 4 weeks and 6 months ( 30.4 + /- 5.5 vs 32.2 + /- 7.0 mL.kg(-1).min(-1 ) , P < .001 ) , with no significant change in MCT ( 28.5 + /- 5.6 vs 29.5 + /- 5.7 mL.kg(-1).min(-1 ) ) . Quality of life improved in both groups from baseline to 4 weeks , remaining improved at 6 months . There were no changes in echocardiographic systolic and diastolic left ventricular function . Adiponectin increased between 4 weeks and 6 months in both groups ( group differences , not significant ) . CONCLUSIONS Four weeks of intense training increased Vo(2peak ) significantly after both AIT and MCT . Six months later , the AIT group had a significantly higher Vo(2peak ) than MCT . The results indicate that AIT and MCT increase Vo(2peak ) similarly in the short term , but with better long-term effect of AIT after CABG We found that interval training provides an effective means to improve the cardiovascular fitness and health status of highly functional patients with coronary artery disease . We also revealed that interval training improves anaerobic tolerance to a greater extent than the traditional exercise training model without increasing the risk to the patient . This research supports the implementation of interval training for highly functional patients with coronary artery disease BACKGROUND Peak oxygen uptake ( pVO2 ) is used for risk stratification in chronic heart failure ( CHF ) , but little is known about the prognostic impact of pVO2-changes in patients on chronic beta-blocker ( BBL ) therapy . We therefore prospect ively evaluated individual pVO2-changes at a 6-month interval in patients all receiving BBL . METHODS 194 patients with stable CHF on stable medication were included ( V1 ) and underwent clinical evaluation and exercise testing . Testing was repeated ( V2 ) at 5.7+/-1.5 months after V1 and patients were followed > 12 months after V2 . Death or hospitalisation due to cardiac reasons was the predefined EP ( EPP , end-point positive ; n=62 ; EPN , end-point negative ; n=113 ) . RESULTS Initial characteristics did not differ between EPP and EPN . Multivariate cox regression analysis revealed that change of pVO2 ( EPP : -0.6+/-2.6 ml/kg min ; EPN : + 2.5+/-3.3 ml/kg min ; p<0.001 ) was independent to pVO2 , LVEF , NTproBNP and NYHA at V2 for prediction of the combined end-point during follow-up . An increase of pVO2 by 10 % was identified as an adequate cut-off value for risk stratification and ROC- analysis showed the significant incremental prognostic value of the determination of pVO2 changes in combination with pVO2 . CONCLUSIONS Serial measurements of pVO2 yield additional information for risk stratification in clinical ly homogenous CHF patients receiving BBL . This is the first study demonstrating this fact within a narrow predefined interval with all patients on BBL The aim of the present study was to investigate effects of aerobic interval training ( AIT ) versus moderate continuous training ( MCT ) on coronary atherosclerosis in patients with significant coronary artery disease on optimal medical treatment . Thirty-six patients were r and omized to AIT ( intervals at ≈ 90 % of peak heart rate ) or MCT ( continuous exercise at ≈ 70 % of peak heart rate ) 3 times a week for 12 weeks after intracoronary stent implantation . Grayscale and radiofrequency intravascular ultrasounds ( IVUS ) were performed at baseline and follow-up . The primary end point was the change in plaque burden , and the secondary end points were change in necrotic core and plaque vulnerability . Separate lesions were classified using radiofrequency IVUS criteria . We demonstrated that necrotic core was reduced in both groups in defined coronary segments ( AIT -3.2 % , MCT -2.7 % , p < 0.05 ) and in separate lesions ( median change -2.3 % and -0.15 mm(3 ) , p < 0.05 ) . Plaque burden was reduced by 10.7 % in separate lesions independent of intervention group ( p = 0.06 ) . No significant differences in IVUS parameters were found between exercise groups . A minority of separate lesions were transformed in terms of plaque vulnerability during follow-up with large individual differences between and within patients . In conclusion , changes in coronary artery plaque structure or morphology did not differ between patients who underwent AIT or MCT . The combination of regular aerobic exercise and optimal medical treatment for 12 weeks induced a moderate regression of necrotic core and plaque burden in IVUS-defined coronary lesions OBJECTIVE : The purpose of this study was to evaluate the following : 1 ) the effects of continuous exercise training and interval exercise training on the end-tidal carbon dioxide pressure ( PETCO2 ) response during a grade d exercise test in patients with coronary artery disease ; and 2 ) the effects of exercise training modalities on the association between PETCO2 at the ventilatory anaerobic threshold ( VAT ) and indicators of ventilatory efficiency and cardiorespiratory fitness in patients with coronary artery disease . METHODS : Thirty-seven patients ( 59.7±1.7 years ) with coronary artery disease were r and omly divided into two groups : continuous exercise training ( n = 20 ) and interval exercise training ( n = 17 ) . All patients performed a grade d exercise test with respiratory gas analysis before and after three months of the exercise training program to determine the VAT , respiratory compensation point ( RCP ) and peak oxygen consumption . RESULTS : After the interventions , both groups exhibited increased cardiorespiratory fitness . Indeed , the continuous exercise and interval exercise training groups demonstrated increases in both ventilatory efficiency and PETCO2 values at VAT , RCP , and peak of exercise . Significant associations were observed in both groups : 1 ) continuous exercise training ( PETCO2VAT and cardiorespiratory fitness r = 0.49 ; PETCO2VAT and ventilatory efficiency r = -0.80 ) and 2 ) interval exercise training ( PETCO2VAT and cardiorespiratory fitness r = 0.39 ; PETCO2VAT and ventilatory efficiency r = -0.45 ) . CONCLUSIONS : Both exercise training modalities showed similar increases in PETCO2 levels during a grade d exercise test in patients with coronary artery disease , which may be associated with an improvement in ventilatory efficiency and cardiorespiratory fitness Background . We tested the hypothesis that high intensity interval training ( HIIT ) would be more effective than moderate intensity continuous training ( MIT ) to improve newly emerged markers of cardiorespiratory fitness in coronary heart disease ( CHD ) patients , as the relationship between ventilation and carbon dioxide production ( VE/VCO2 slope ) , oxygen uptake efficiency slope ( OUES ) , and oxygen pulse ( O2P ) . Methods . Seventy-one patients with optimized treatment were r and omly assigned into HIIT ( n = 23 , age = 56 ± 12 years ) , MIT ( n = 24 , age = 62 ± 12 years ) , or nonexercise control group ( CG ) ( n = 24 , age = 64 ± 12 years ) . MIT performed 30 min of continuous aerobic exercise at 70–75 % of maximal heart rate ( HRmax ) , and HIIT performed 30 min sessions split in 2 min alternate bouts at 60%/90 % HRmax ( 3 times/week for 16 weeks ) . Results . No differences among groups ( before versus after ) were found for VE/VCO2 slope or OUES ( P > 0.05 ) . After training the O2P slope increased in HIIT ( 22 % , P < 0.05 ) but not in MIT ( 2 % , P > 0.05 ) , while decreased in CG ( −20 % , P < 0.05 ) becoming lower versus HIIT ( P = 0.03 ) . Conclusion . HIIT was more effective than MIT for improving O2P slope in CHD patients , while VE/VCO2 slope and OUES were similarly improved by aerobic training regimens versus controls Objective : Exercise capacity strongly predicts survival and aerobic interval training ( AIT ) increases peak oxygen uptake effectively in cardiac patients . Usual care in Norway provides exercise training at the hospitals following myocardial infa rct ion ( MI ) , but the effect and actual intensity of these rehabilitation programmes are unknown . Design : R and omized controlled trial . Setting : Hospital cardiac rehabilitation . Subjects : One hundred and seven patients , recruited two to 12 weeks after MI , were r and omized to usual care rehabilitation or treadmill AIT . Interventions : Usual care aerobic group exercise training or treadmill AIT as 4 × 4 minutes intervals at 85–95 % of peak heart rate . Twice weekly exercise training for 12 weeks . Main measures : The primary outcome measure was peak oxygen uptake . Secondary outcome measures were endothelial function , blood markers of cardiovascular disease , quality of life , resting heart rate , and heart rate recovery . Results : Eighty-nine patients ( 74 men , 15 women , 57.4 ± 9.5 years ) completed the programme . Peak oxygen uptake increased more ( P = 0.002 ) after AIT ( from 31.6 ± 5.8 to 36.2 ± 8.6 mL·kg−1·min−1 , P < 0.001 ) than after usual care rehabilitation ( from 32.2 ± 6.7 to 34.7 ± 7.9 mL·kg−1·min−1 , P < 0.001 ) . The AIT group exercised with significantly higher intensity in the intervals compared to the highest intensity in the usual care group ( 87.3 ± 3.
Output:
| Conclusions High-intensity interval training may improve peak oxygen uptake and should be considered as a component of care of coronary artery disease patients .
However , this superiority disappeared when isocaloric protocol is compared |
MS212996 | ***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 We set out to assess the new Aberdeen Varicose Veins Question naire ( Aberdeen Question naire ) for the properties necessary for a valid measure of health outcome , to determine quality of life of patients with varicose veins , and to determine the effect of surgery on quality of life . METHODS A prospect i ve consecutive cohort of 137 patients undergoing varicose vein surgery completed the self-administered SF-36 and Aberdeen Question naire and 25 questions relating to the symptoms and concerns of patients with varicose veins . Follow-up was done by repeated question naires 6 weeks after surgery . The Aberdeen Question naire was assessed for reliability , validity , responsiveness , and practicality . Quality of life of patients with varicose veins was compared with an age- and sex-matched sample of the general population . RESULTS Reliability estimates for the 8 scales short-form health survey ( SF-36 ) and the Aberdeen Question naire were all above 0.7 ( Cronbach 's alpha ) . The Aberdeen Question naire had a highly significant correlation ( r = 0 . 74 , P < .0001 ) with the patients ' symptoms and concerns question naire , which is evidence of its validity . Patients with varicose veins score lower than United Kingdom norms ( P < .001 ) in the physical domains of the SF-36 , indicating worse health . After surgery , the SF-36 scores improved in all 8 domains of health , reaching significance in " Mental Health " ( P < .05 ) and approaching significance in " General Health " ( P = .066 ) . The Health Transition Item of the SF-36 and the Aberdeen Question naire both showed a highly significant improvement in health ( P < .001 ) . CONCLUSION The Aberdeen Question naire is a valid measure of quality of life for patients with varicose veins . Persons with varicose veins have a reduced quality of life compared with the general population , and this discrepancy is significantly improved at 6 weeks by operating on them OBJECTIVE To determine whether a period of one or three weeks of compression following varicose vein surgery influenced the outcome . DESIGN R and omised controlled trial . METHOD 300 patients aged between 18 - 80 years underwent unilateral varicose vein surgery in a Day Procedure Unit . Compression b and aging was applied post-operatively for three days . Patients then wore graduated elastic compression stockings r and omised to a period of either one or three weeks . Patients were assessed by question naire on pain scores at rest and during mobilisation for up to six weeks , total analgesic consumption , duration of time off work , any complications , and patient perception of cosmetic results at various periods up to 12 weeks following surgery . RESULTS The mean pain score reported by patients over 6 weeks was similar in the two groups ( 1 week group : mean 2.18 , three week group : mean 1.87 ) . The 95 % confidence interval ( CI ) for the mean difference in pain was ( -0.05 - 0.66 ) . Analysis of the pain curves at 1 week , 4 weeks and 6 weeks , showed equivalence at 4 and 6 weeks , but not for 1 week , with the group wearing stockings for only one week complaining of more pain for this period . A significant increase in the total number of analgesia tablets consumed was also found in the group wearing stockings for only one week . No significant differences were found in the other secondary endpoints - return to work ( categorised as < 2 weeks , 2 - 6 weeks or 6 - 12 weeks ) , patient satisfaction or post-operative complications . CONCLUSION We found no benefit in wearing compression stockings for more than one week following uncomplicated high saphenous ligation with stripping of the great saphenous vein with respect to post-operative pain , number of complications , time to return to work , or patient satisfaction for up to 12 weeks following surgery Quality of life may be considerably reduced in patients who are suffering from chronic lower limb venous insufficiency , although existing generic quality of life instruments ( NHP , SF-36 or SIP ) can not completely identify their specific complaints . The Chronic Venous Insufficiency Question naire ( CIVIQ ) has been developed by iterative process . First , a pilot group of 20 patients was used to identify a number of important features of quality of life affected by venous insufficiency , other than physical symptoms of discomfort . A second study involving 2,001 subjects was used to reduce the number of items . Subjects were asked to score both the severity of their problems and the importance they attributed to each problem on a 5-point Likert scale . The importance items found in patients with venous insufficiency were subjected to factorial analyses ( PCA , PAF ) . The final version is a 20-item self-administered question naire which explores four dimensions : psychological , physical and social functioning and pain . Internal consistency of the question naire was vali date d for each dimension ( Cronbach 's alpha > 0.820 for three out of four factors ) . Reproducibility was confirmed in a 60 patient test-retest study . Pearson 's correlation coefficients for both the four dimension subscales and for the global score at 2-week intervals were greater than 0.940 . Finally , the question naire was tested in a r and omized clinical trial of 934 patients in order to assess responsiveness and the convergent validity of the instrument , together with the patient 's own quality of life . This study demonstrated that convergence was valid : Pearson 's correlation coefficients between clinical score differences and quality of life score differences were small ( from 0.199–0.564 ) but were statistically different from 0 ( p<0.001 ) . St and ardized response mean ( SRM ) and effect size ( ES ) were calculated to assess sensitivity to change . SRM and ES both demonstrated considerble responsiveness to change ( > 0.80 ) . Reliability , face , content , construct validity and responsiveness were also determined for this specific quality of life question naire relating to venous insufficiency . Results suggest that this question naire may be used with confidence to assess quality of life in clinical trials on chronic venous insufficiency OBJECTIVE --To develop a valid and reliable outcome measure for patients with varicose veins . DESIGN --Postal question naire survey of patients with varicose veins . SETTING --Surgical outpatient departments and training general practice s in Grampian region . SUBJECTS--373 patients , 287 of whom had just been referred to hospital for their varicose veins and 86 who had just consulted a general practitioner for this condition and , for comparison , a r and om sample of 900 members of the general population . MAIN MEASURES --Content validity , internal consistency , and criterion validity . RESULTS --281(76 % ) patients ( mean age 45.8 ; 76 % female ) and 542(60 % ) of the general population ( mean age 47.9 ; 54 % female ) responded . The question naire had good internal consistency as measured by item-total correlations . Factor analysis identified four important health factors : pain and dysfunction , cosmetic appearance , extent of varicosity and complications . The validity of the question naire was demonstrated by a high correlation with the SF-36 health profile , which is a general measure of patients ' health . The perceived health of patients with varicose veins , as measured by the SF-36 , was significantly lower than that of the sample of the general population adjusted for age and a lower proportion of women . CONCLUSION --A clinical ly derived question naire can provide a valid and reliable tool to assess the perceived health of patients with varicose veins . IMPLICATION S -- The question naire may be used to justify surgical treatment of varicose veins BACKGROUND Neoreflux at the sapheno-femoral junction ( SFJ ) is an important cause of recurrent great saphenous varicose veins . This study compares four surgical methods of ligating the SFJ with the aim to reduce the rate of neoreflux . METHOD In a prospect i ve study , 379 patients ( 500 SFJ ligations ) were r and omised to one of four surgical procedures at the SFJ ( 125 groins each ) . In group A ( control group ) the SFJ was ligated in st and ard fashion with Vicryl ( absorbable ligature ) ; in group B , after Vicryl ligation continuous Prolene ( non-absorbable ) was sutured over the stump endothelium to prevent any contact with surrounding tissue ; in group C. SFJ ligation was done with Ethibond ( non-absorbable ) ; in group D Ethibond ligation was followed by Prolene oversewing . The final study group included 114 patients ( 152 groins ) who were all known to be free from recurrent groin reflux 3 months postoperatively and had colour duplex venous imaging 2 years after operation . RESULTS Duplex imaging identified neoreflux at the SFJ in 10 out of 114 groins after 2 years ( 7 % ) . There were differences in the rates between the four groups : Group A 3/31 ( 10 % ) , Group B 0/32 , Group C 5/44 ( 11 % ) and Group D 2/45 ( 4 % ) . Neoreflux was significantly reduced in the two groups with endothelial closure ( B and D ) : 2/70 ( 3 % ) versus 8/75 ( 11 % , p<0.025 ) . CONCLUSION Recurrent reflux in the groin was reduced by over sewing the ligated SFJ in patients having varicose vein surgery . This adds weight to the theory of neovascularisation as a cause of recurrent veins and offers a means to reduce clinical recurrence rates AIM The innovations for disease management need to be thoroughly evaluated so that their benefits and potential downsides can be compared with the already existing approaches . Endovascular laser ( EVL ) treatment for varicose veins offers today several advantages over surgical st and ard stripping . The Italian Endovenous-laser Working Group ( IEWG ) is a homogeneous group of surgeons and phlebologists who have been using EVL since 1999 and has undertaken to examine EVL in a multicenter study starting from a well defined rationale , with the benefit of a single protocol to use . METHODS In a cooperative , multicenter , clinical study , 1076 limbs in 1050 patients , mean age of 54.5 years , 241 males and 809 females affected by chronic venous insufficiency ( CVI ) were considered eligible for surgery and stratified by CEAP classification in a four-year period ( January 1999 December 2003 ) . Inclusion criteria were insufficiency of the great and /or small saphenous vein at various levels , beyond those accessory saphenous trunks with incompetence in the saphenofemoral junction . In all cases truncular reflux apparead up on duplex scan examination , with or without associated varicosities . All the patients underwent a surgery on the basis of the clinical assessment . All the centres involved performed treatment in conformity with the Food and Drug Administration ( FDA ) vali date d procedure , using an endo-laser venous system kit with a 810 - 980 nm diode . Duplex scan was performed in all patients after 36 months with very few lost to follow-up cases . RESULTS In the immediate postoperative period the results have been impressive , with a very effective closure of incompetent great saphenous vein and the other treated varicose veins ( the early occlusion rate has been 99 % ) . Major complications have not been detected : in particular , no deep venous thrombosis ( DVT ) evaluated duplex ultrasound . The patients ' acceptability and satisfaction regarding the procedure , have been measured by means of a question naire on the quality of life , and the result was 96.7 % . After 36 months , the total occusion rate of saphenous trunks has been 97 % . CONCLUSIONS The first important Italian experience with EVL based on preoperative , perioperative and postoperative duplex control and which is also based on the patients ' satisfaction at mid/long-term has indicated some advantages over the st and ard treatment with the stripping method . In terms of reduced postoperative pain , shorter sick leave , a faster resumption of the normal activities , and , in particular , the total absence of DVT , we can conclude that EVL is a good solution for all patients with anatomic and hemodinamic patterns for saphenous vein surgery Endovenous laser ablation ( EVLA ) is a minimally invasive technique for treating varicose veins due to truncal vein incompetence . This r and omized trial compared EVLA with conventional surgery in patients with primary saphenofemoral and great saphenous vein ( GSV ) reflux OBJECTIVE Conventional surgery for varicose veins due to small saphenous reflux is associated with high recurrence rates ( up to 50 % ) , many result ing from inadequate surgery . This prospect i ve audit examines the safety and efficacy of EVLA in the treatment of this . METHOD 65 patients ( 68 limbs ) with varicosities due to primary or recurrent sapheno-popliteal junction ( SPJ ) and small saphenous vein ( SSV ) reflux underwent out-patient EVLA ( 810 nm diode laser ) . The SSV was ablated from mid-calf to the SPJ . Symptomatic improvement ( Aberdeen Varicose Vein Severity Score [ AVVSS ] ) , time to return to normal activity , post-EVLA analgesic requirements , and complications were recorded . RESULTS Duplex ultrasound follow-up ( median 6-months ) confirmed abolition of SPJ/SSV reflux in all limbs following a median total laser energy delivery of 1131J ( IQR 928 - 1364 ) at an energy density of 66.3 Joules/cm ( IQR 54.2 - 71.
Output:
| Serious adverse events after ELT or surgery were rare .
While occurrence rates of some minor adverse events appeared higher after ELT in collated data , comparative studies commonly favored ELT over surgery .
Few differences were apparent between treatments with respect to clinical effectiveness outcomes , although long-term follow-up was lacking .
Non clinical effectiveness outcomes generally favored ELT over surgery in the first 2 months after treatment .
ELT appears to be at least as safe as surgery . |
MS212997 | ***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: Sentinel lymph node biopsy ( SLNB ) is the st and ard surgical procedure for the axilla in early node-negative breast cancer . To date , the " gold st and ard " to localize the sentinel lymph node ( SLN ) is the radiotracer (99m)Tc with or without blue dye . The aim of this study was to evaluate potential equivalency of the new SentiMag ( ® ) technique in comparison to the " gold st and ard " . Within this prospect i ve , multicentric and multinational non-inferiority study including 150 patients (99m)Tc was compared with the magnetic technique , using superparamagnetic iron oxide particles ( SPIOs , Sienna+ ( ® ) ) for localization of SLNs . The results showed a detection rate per patient of 97.3 % ( 146/150 ) for (99m)Tc vs. 98.0 % ( 147/150 ) for Sienna+ ( ® ) with a similar average number of removed SLNs per patient and a higher per patient malignancy detection rate for the SPIO tracer . We obtained convincing results that magnetic SLNB can be performed easily , safely and equivalently well in comparison to the radiotracer method Background Sentinel lymph node biopsy ( SLNB ) in melanoma is currently performed using the st and ard dual technique ( radioisotope and blue dye ) . The magnetic technique is non-radioactive and provides a brown color change in the sentinel lymph node ( SLN ) through an intradermal injection of a magnetic tracer , and utilizes a h and held magnetometer . The MELAMAG Trial compared the magnetic technique with the st and ard technique for SLNB in melanoma . Methods Clinical ly node-negative patients with primary cutaneous melanoma were recruited from four centers . SLNB was undertaken after intradermal administration of both the st and ard ( blue dye and radioisotope ) and magnetic tracers . The SLN identification rate per patient , with the two techniques , was compared . Results A total of 133 patients were recruited , 129 of which were available for final analysis . The sentinel node identification rate was 97.7 % ( 126/129 ) with the st and ard technique and 95.3 % ( 123/129 ) with the magnetic technique [ 2.3 % difference ; 95 % upper confidence limit ( CL ) 6.4 ; 5.4 % discordance ] . With radioisotope alone , the SLN identification rate was 95.3 % ( 123/129 ) , as with the magnetic technique ( 0 % difference ; 95 % upper CL 4.5 ; 7.8 % discordance ) . The lymph node retrieval rate was 1.99 nodes per patient overall , 1.78 with the st and ard technique and 1.87 with the magnetic technique . Conclusions The magnetic technique is feasible for SLNB in melanoma with a high SLN identification rate , but is associated with skin staining . When compared with the st and ard dual technique , it did not reach our predefined non-inferiority margin BACKGROUND AND OBJECTIVES The French Sentimag feasibility trial evaluated a new method for the localization of breast cancer sentinel lymph node ( SLN ) using Sienna+ ® , superparamagnetic iron oxide particles , and Sentimag ® detection in comparison to the st and ard technique ( isotopes ± blue dye ) . METHODS We conducted a prospect i ve multicentric paired comparison trial on 115 patients . SLN localization was performed using both the magnetic technique and the st and ard method . Detection rate and concordance between magnetic and st and ard tracers were calculated . Post-operative complications were assessed after 30 days . RESULTS Results are based on 108 patients . SLN identification rate was 98.1 % [ 93.5 - 99.8 ] for both methods , 97.2 % [ 92.1 - 99.4 ] for Sienna+ ® and 95.4 % [ 89.5 - 98.5 ] for st and ard technique . A mean of 2.1 SLNs per patient was removed . The concordance rate was 99.0 % [ 94.7 - 100.0 % ] per patient and 97.4 % [ 94.1 - 99.2 ] per node . Forty-six patients ( 43.4 % ) had nodal involvement . Among involved SLNs , concordance rate was 97.7 % [ 88.0 - 99.9 ] per patient and 98.1 % [ 90.1 - 100.0 ] per node . CONCLUSIONS This new magnetic tracer is a feasible method and a promising alternative to the isotope . It could offer benefits for ambulatory surgery or sites without nuclear medicine departments . J. Surg . Oncol . 2016;113:501 - 507 . © 2016 Wiley Periodicals , Background The r and omized EORTC 10981 - 22023 AMAROS trial investigates whether breast cancer patients with a tumor-positive sentinel node biopsy ( SNB ) are best treated with an axillary lymph node dissection ( ALND ) or axillary radiotherapy ( ART ) . The aim of the current sub study was to evaluate the identification rate and the nodal involvement . Methods The first 2,000 patients participating in the AMAROS trial were evaluated . Associations between the identification rate and technical , patient- , and tumor-related factors were evaluated . The outcome of the SNB procedure and potential further nodal involvement was assessed . Results In 65 patients , the sentinel node could not be identified . As a result , the sentinel node identification rate was 97 % ( 1,888 of 1,953 ) . Variables affecting the success rate were age , pathological tumor size , histology , year of accrual , and method of detection . The SNB results of 65 % of the patients ( n = 1,220 ) were negative and the patients underwent no further axillary treatment . The SNB results were positive in 34 % of the patients ( n = 647 ) , including macrometastases ( n = 409 , 63 % ) , micrometastases ( n = 161 , 25 % ) , and isolated tumor cells ( n = 77 , 12 % ) . Further nodal involvement in patients with macrometastases , micrometastases , and isolated tumor cells undergoing an ALND was 41 , 18 , and 18 % , respectively . Conclusions With a 97 % detection rate in this prospect i ve international multicenter study , the SNB procedure is highly effective , especially when the combined method is used . Further nodal involvement in patients with micrometastases and isolated tumor cells in the sentinel node was similar — both were 18 % BACKGROUND Sentinel lymph node biopsy in women with operable breast cancer is routinely used in some countries for staging the axilla despite limited data from r and omized trials on morbidity and mortality outcomes . We conducted a multicenter r and omized trial to compare quality -of-life outcomes between patients with clinical ly node-negative invasive breast cancer who received sentinel lymph node biopsy and patients who received st and ard axillary treatment . METHODS The primary outcome measures were arm and shoulder morbidity and quality of life . From November 1999 to October 2003 , 1031 patients were r and omly assigned to undergo sentinel lymph node biopsy ( n = 515 ) or st and ard axillary surgery ( n = 516 ) . Patients with sentinel lymph node metastases proceeded to delayed axillary clearance or received axillary radiotherapy ( depending on the protocol at the treating institution ) . Intention-to-treat analyses of data at 1 , 3 , 6 , and 12 months after surgery are presented . All statistical tests were two-sided . RESULTS The relative risks of any lymphedema and sensory loss for the sentinel lymph node biopsy group compared with the st and ard axillary treatment group at 12 months were 0.37 ( 95 % confidence interval [ CI ] = 0.23 to 0.60 ; absolute rates : 5 % versus 13 % ) and 0.37 ( 95 % CI = 0.27 to 0.50 ; absolute rates : 11 % versus 31 % ) , respectively . Drain usage , length of hospital stay , and time to resumption of normal day-to-day activities after surgery were statistically significantly lower in the sentinel lymph node biopsy group ( all P < .001 ) , and axillary operative time was reduced ( P = .055 ) . Overall patient-recorded quality of life and arm functioning scores were statistically significantly better in the sentinel lymph node biopsy group throughout ( all P < or = .003 ) . These benefits were seen with no increase in anxiety levels in the sentinel lymph node biopsy group ( P > .05 ) . CONCLUSION Sentinel lymph node biopsy is associated with reduced arm morbidity and better quality of life than st and ard axillary treatment and should be the treatment of choice for patients who have early-stage breast cancer with clinical ly negative nodes A mini-symposium was held in Montreal , Canada , at the International Surgical Week for the Breast Surgical International in 2007 addressing the question whether breast cancer is the same disease in Asian and Western countries . Numerous investigators from Asian and Western countries presented the epidemiologic and clinical outcome data of women with breast cancer . Although there are significant similarities , the striking difference is that the peak age for breast cancer is between 40 and 50 years in the Asian countries , whereas the peak age in the Western countries is between 60 and 70 years . Also , the incidence of breast cancer in Asia is rising and is associated with increased mortality . In the West , although the incidence is increasing , the mortality rate is definitely decreasing . Future prospect i ve data collection from Asian and Western countries may provide further interesting epidemiologic and outcome data regarding the outcome of women with breast cancer from Asian and Western countries . Background Whether breast cancer is the same disease in Asian and Western countries was the topic of a 2007 Breast Surgery International symposium at International Surgical Week . Methods Participating investigators from China , Taiwan , India , Japan , South Korea , Sweden , Canada , and the United States were asked beforeh and to provide data on the epidemiology and treatment outcome of women in their countries . Results Comparisons of the epidemiologic and clinical outcome data of women with breast cancer showed significant similarities , but the striking difference is that the peak age is between 40 and 50 years in Asian countries , but is between 60 and 70 years in Western countries . The incidence of breast cancer in Asia is rising and is associated with increased mortality . In the West , although the incidence is also increasing , the mortality rate is definitely decreasing . Discussion Future prospect i ve data collection from Asian and Western countries may provide further interesting epidemiologic and outcome data regarding the outcome of women with breast cancer from Asian and Western countries Background [99mTc]Tilmanocept is a CD206 receptor-targeted radiopharmaceutical design ed for sentinel lymph node ( SLN ) identification . Two nearly identical nonr and omized phase III trials compared [99mTc]tilmanocept to vital blue dye . Methods Patients received [99mTc]tilmanocept and blue dye . SLNs identified intraoperatively as radioactive and /or blue were excised and histologically examined . The primary end point , concordance , was the proportion of blue nodes detected by [99mTc]tilmanocept ; 90 % concordance was the prespecified minimum concordance level . Reverse concordance , the proportion of radioactive nodes detected by blue dye , was also calculated . The prospect i ve statistical plan combined the data from both trials . Results Fifteen centers contributed 154 melanoma patients who were injected with both agents and were intraoperatively evaluated . Intraoperatively , 232 of 235 blue nodes were detected by [99mTc]tilmanocept , for 98.7 % concordance ( p < 0.001 ) . [99mTc]Tilmanocept detected 364 nodes , for 63.7 % reverse concordance ( 232 of 364 nodes ) . [99mTc]Tilmanocept detected at least one node in more patients ( n = 150 ) than blue dye ( n = 138 , p = 0.002 ) . In 135 of 138 patients with at least one blue node , all blue nodes were radioactive . Melanoma was identified in the SLNs of 22.1 % of patients ; all 45 melanoma-positive SLNs were detected by [99mTc]tilmanocept , whereas blue dye detected only 36 ( 80 % ) of 45 ( p = 0.004 ) . No positive SLNs were detected exclusively by blue dye . Four of 34 node-positive patients were identified only by [99mTc]tilmanocept , so 4 ( 2.6 % ) of 154 patients were correctly staged only by [99mTc]tilmanocept . No serious adverse events were attributed to [99mTc]tilmanocept . Conclusions [99mTc]Tilmanocept met the prespecified concordance primary end point , identifying 98.7 % of blue nodes . It identified more SLNs in more patients , and identified more melanoma-containing nodes than blue dye Background The SentiMAG Multicentre Trial evaluated a new magnetic technique for sentinel lymph node biopsy ( SLNB ) against the st and ard ( radioisotope and blue dye or radioisotope alone ) . The magnetic technique does not use radiation
Output:
| The magnetic technique for SLNB is non-inferior to the st and ard technique , with a high identification rate but with a significantly higher lymph node retrieval rate |
MS212998 | ***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 energy density ( ED ; kcal/g ) of an entrée influences children 's energy intake ( EI ) , but the effect of simultaneously changing both ED and portion size of an entrée on preschool children 's EI is unknown . In this within-subject crossover study , 3- to 5-year-old children ( 30 boys , 31 girls ) in a daycare facility were served a test lunch once/week for 4 weeks . The amount and type of vegetables and cheeses incorporated into the sauce of a pasta entrée were manipulated to create two versions that varied in ED by 25 % ( 1.6 or 1.2 kcal/g ) . Across the weeks , each version of the entrée was served to the children in each of two portion sizes ( 400 or 300 g ) . Lunch , consumed ad libitum , also included carrots , applesauce , and milk . Decreasing ED of the entrée by 25 % significantly ( P<0.0001 ) reduced children 's EI of the entrée by 25 % ( 63.1+/-8.3 kcal ) and EI at lunch by 17 % ( 60.7+/-8.9 kcal ) . Increasing the proportion of vegetables in the pasta entrée increased children 's vegetable intake at lunch by half of a serving of vegetables ( P<0.01 ) . Decreasing portion size of the entrée by 25 % did not significantly affect children 's total food intake or EI at lunch . Therefore , reducing the ED of a lunch entrée result ed in a reduction in children 's EI from the entrée and from the meal in both portion size conditions . Decreasing ED by incorporating more vegetables into recipes is an effective way of reducing children 's EI while increasing their vegetable intake BACKGROUND The results of previous studies indicated that energy density , independent of fat content , influences energy intake . In most studies , however , both fat content and energy density were lower than in typical American diets . OBJECTIVE We examined the influence of energy density on intake when fat content was above , below , or similar to the amount of fat typically consumed and when energy density was closer to that of American diets . DESIGN Lean ( n = 19 ) and obese ( n = 17 ) women consumed all meals daily in our laboratory during 6 experimental sessions . The main entrées , consumed ad libitum , were formulated to vary in fat content ( 25 % , 35 % , and 45 % of energy ) and energy density ( 5.23 kJ/g , or low energy density , and 7.32 kJ/g , or high energy density ) but to have similar palatability . RESULTS Energy density influenced energy intake across all fat contents in both lean and obese women ( P < 0.0001 ) . Women consumed less energy in the low ( 7531 kJ ) than in the high ( 9414 kJ ) energy density condition . Despite this 20 % lower energy intake , there were only small differences in hunger ( 7 % ) and fullness ( 5 % ) . Women consumed a similar volume , but not weight , of food daily across conditions . Differences in intake by weight , but not volume , occurred because for some versions of manipulated foods , weight and volume were not directly proportional . CONCLUSIONS Energy density affected energy intake across different fat contents and at levels of energy density comparable with those in typical diets . Furthermore , our findings suggest that cues related to the amount of food consumed have a greater influence on short-term intake than does the amount of energy consumed BACKGROUND The contribution of energy density ( ED ) of the total diet to increased risk of obesity from childhood into adolescence is unclear . OBJECTIVE We assessed the relation between the ED of the diet in childhood , calculated in a number of ways , and change in adiposity from childhood to adolescence . DESIGN In a prospect i ve study , 48 children ( 30 boys , 18 girls ) were initially studied at age 6 - 8 y ( baseline ) and followed up at age 13 - 17 y. Daily ED , energy intake , and food intake were assessed at baseline by 7-d weighed food records concurrent with estimates of total energy expenditure ( TEE ) by doubly labeled water . ED was calculated with the use of 5 published methods . Obesity risk was defined with the use of body fat from total body water by isotope dilution . Body fat was normalized for height and expressed as fat mass index ( FMI ) . Change in adiposity was calculated as follow-up FMI minus baseline FMI . RESULTS Misreporting of energy intake at the group level at baseline was low relative to the TEE . ED of the total diet at baseline by the 3 methods for calculating ED that excluded all or most beverages was prospect ively associated with change in FMI . However , ED of the total diet by any of the methods was not associated with change in the percentage body fat , body mass index , or waist circumference z scores . CONCLUSION The methods used to calculate ED and to assess obesity risk lead to different conclusions about the relation between the ED of the diet in childhood and gain in fat into adolescence BACKGROUND Consuming foods low in energy density ( kcal/g ) decreases energy intake over several days , but the effectiveness of this strategy for weight loss has not been tested . OBJECTIVE The effects on weight loss of 2 strategies for reducing the energy density of the diet were compared over 1 y. DESIGN Obese women ( n = 97 ) were r and omly assigned to groups counseled either to reduce their fat intake ( RF group ) or to reduce their fat intake and increase their intake of water-rich foods , particularly fruit and vegetables ( RF+FV group ) . No goals for energy or fat intake were assigned ; the subjects were instructed to eat ad libitum amounts of food while following the principles of their diet . RESULTS After 1 y , study completers ( n = 71 ) in both groups had significant decreases in body weight ( P < 0.0001 ) . Subjects in the RF+FV group , however , had a significantly different pattern of weight loss ( P = 0.002 ) than did subjects in the RF group . After 1 y , the RF+FV group lost 7.9 + /- 0.9 kg and the RF group lost 6.4 + /- 0.9 kg . Analysis of all r and omly assigned subjects also showed a different pattern of weight loss between groups ( P = 0.021 ) . Diet records indicated that both groups had similar reductions in fat intake . The RF+FV group , however , had a lower dietary energy density than did the RF group ( P = 0.019 ) as the result of consuming a greater weight of food ( P = 0.025 ) , especially fruit and vegetables ( P = 0.037 ) . The RF+FV group also reported less hunger ( P = 0.003 ) . CONCLUSION Reducing dietary energy density , particularly by combining increased fruit and vegetable intakes with decreased fat intake , is an effective strategy for managing body weight while controlling hunger BACKGROUND Dietary energy density ( ED ) reductions are associated with energy intake ( EI ) reductions . Little is known about influences on body weight ( BW ) . OBJECTIVES We examined the effects of behavioral interventions on ED values and explored how 6-mo ED changes relate to BW . DESIGN Prehypertensive and hypertensive persons were r and omly assigned to 1 of 3 groups : the established group received an 18-session intervention implementing well-established hypertension recommendations ( eg , weight loss , sodium reduction , and physical activity ) , the established+Dietary Approaches to Stop Hypertension ( DASH ) group received an 18-session intervention also implementing the DASH diet , and the advice group received 1 session on these topics . Two 24-h dietary recalls were collected ( n=658 ) . RESULTS Each group had significant declines in EI , ED , and BW . The established and established+DASH groups had the greatest EI and BW reductions . The established+DASH group had the greatest ED reduction and the greatest increase in the weight of food consumed . When groups were combined and analyzed by ED change tertiles , participants in the highest tertile ( ie , largest ED reduction ) lost more weight ( 5.9 kg ) than did those in the middle ( 4.0 kg ) or lowest ( 2.4 kg ) tertile . Participants in the highest and middle tertiles increased the weight of food they consumed ( 300 and 80 g/d , respectively ) but decreased their EI ( 500 and 250 kcal/d ) . Conversely , those in the lowest tertile decreased the weight of food consumed ( 100 g/d ) , with little change in EI . The highest and middle tertiles had favorable changes in fruit , vegetable , vitamin , and mineral intakes . CONCLUSION Both large and modest ED reductions were associated with weight loss and improved diet quality To examine whether artificial sweeteners aid in the control of long-term food intake and body weight , we gave free-living , normal-weight subjects 1150 g soda sweetened with aspartame ( APM ) or high-fructose corn syrup ( HFCS ) per day . Relative to when no soda was given , drinking APM-sweetened soda for 3 wk significantly reduced calorie intake of both females ( n = 9 ) and males ( n = 21 ) and decreased the body weight of males but not of females . However , drinking HFCS-sweetened soda for 3 wk significantly increased the calorie intake and body weight of both sexes . Ingesting either type of soda reduced intake of sugar from the diet without affecting intake of other nutrients . Drinking large volumes of APM-sweetened soda , in contrast to drinking HFCS-sweetened soda , reduces sugar intake and thus may facilitate the control of calorie intake and body weight BACKGROUND Little is known about the long-term effects of dietary energy density ( ED ) on weight gain . OBJECTIVE The objective was to assess the long-term relation between changes in dietary ED and age-related weight gain . DESIGN We conducted a prospect i ve study of 50 026 women ( x + /- SD age : 36.5 + /- 4.6 y ) in the Nurses ' Health Study II followed from 1991 to 1999 . Dietary ED and body weight were ascertained in 1991 , 1995 , and 1999 . Total dietary ED was calculated by dividing each subject 's daily energy intake ( kcal ) by the reported weight ( g ) of all foods consumed . RESULTS Dietary ED was positively correlated with saturated fat ( r = 0.16 ) , trans fat ( r = 0.15 ) , and the glycemic index ( r = 0.16 ) , but was inversely correlated with vegetable protein ( r = -0.30 ) , vegetables ( r = -0.27 ) , and fruit ( r = -0.17 ) . ED was not significantly correlated with total fat intake as a percentage of energy ( r = 0.08 ) . Women who increased their dietary ED during follow-up the most ( 5th quintile ) had a significantly greater multivariate-adjusted weight gain than did those who decreased their dietary ED ( 1st quintile ) ( 8-y time period : 6.42 kg compared with 4.57 kg ; P for trend < 0.001 ) . However , the amount of weight change over time varied considerably according to the ED values of individual foods and beverages . CONCLUSION A high dietary ED reflects a dietary pattern higher in saturated and trans fats and refined carbohydrates . Increases in dietary ED were associated with greater weight gain among middle-aged women during 8 y of follow-up . However , public health recommendations can not be made simply on the basis of ED values of individual foods and beverages We previously increased the energy density and fat content across three diets ( factorial design ) , which led to a marked increase in energy intake in six men over 7 d while continuously resident in a whole-body indirect calorimeter . In the present study we fed the same diets to seven men who were resident in , but not confined to , a metabolic suite for 2 wk/diet . This added a component of increased physical activity . The fat , carbohydrate , and protein contents , respectively , of each diet ( as a percent of energy ) were as follows : low-fat ( LF ) , 20:67:13 ; medium-fat ( MF ) , 40:47:13 ; and high-fat ( HF ) , 60:27:13 . Energy density increased as the percent of fat in the diet increased . Energy intakes from the LF , MF , and HF diets ( 9.11 , 10.32 , and 12.78 MJ/d , respectively ) were almost identical to those in our calorimeter study ( 9.02 , 10.2 , and 12.35 MJ/d , respectively ) whereas energy expenditures ( estimated by the doubly labeled water method ) were 12.45 , 12.10 , and 11.97 MJ/d on the LF , MF and HF diets , respectively , compared with 9.48 , 9.53 , and 9.78 MJ/d , respectively , in our calorimeter study . This finding suggests that diet composition and energy expenditure combined influence energy balance in humans BACKGROUND The rising prevalence of obesity in children has been linked in part to the consumption of sugar-sweetened drinks . Our aim was to examine this relation . METHODS We enrolled 548 ethnically diverse schoolchildren ( age 11.7 years , SD 0.8 ) from public schools in four Massachusetts communities , and studied them prospect ively for 19 months from October , 1995 , to May , 1997 . We examined the association between
Output:
| We posit , based on the experimental evidence , that calculating the energy density of diets by excluding drinks and including calories from drinks as a covariate in the analysis is the most valid and reliable method of testing the relationship between energy density and weight gain in free-living humans . |
MS212999 | ***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 A double-blind , placebo-controlled , multicenter study , was performed to evaluate the efficacy and safety of ziprasidone in 139 patients with an acute exacerbation of schizophrenia or schizoaffective disorder . Patients were r and omized to receive ziprasidone 40 mg/day , 120 mg/day or placebo for 28 days . Ziprasidone 120 mg/day was significantly more effective than placebo in improving the BPRS total , CGI-S , BPRS depression cluster and BPRS anergia cluster scores ( all P < 0.05 ) . Similarly , the percentages of patients classified as responders on the BPRS ( ≥30 % reduction ) and the CGI improvement ( score ≤2 ) were significantly greater with ziprasidone 120 mg/day compared with placebo ( P < 0.05 ) . The number of patients who experienced an adverse event was similar in all three treatment groups , and discontinuation due to adverse events was rare ( five of 91 ziprasidone-treated patients ) . The most frequently reported adverse events , that were more common in either ziprasidone group than in the placebo group , were dyspepsia , constipation , nausea and abdominal pain . There was a notably low incidence extrapyramidal side-effects ( including akathisia ) and postural hypotension and no pattern of laboratory abnormalities or apparent weight gain . Ziprasidone-treated patients were not clinical ly different from placebo-treated patients on the Simpson-Angus Rating scale , Barnes Akathisia scale and AIMS assessment s. These results indicate that ziprasidone 120 mg/day is effective in the treatment of the positive , negative and affective symptoms of schizophrenia and schizoaffective disorder with a very low side-effect burden In this double-blind study , patients with an acute exacerbation of schizophrenia or schizoaffective disorder were r and omized to receive either ziprasidone 80 mg/day ( n = 106 ) or 160 mg/day ( n = 104 ) or placebo ( n = 92 ) , for 6 weeks . Both doses of ziprasidone were statistically significantly more effective than placebo in improving the PANSS total , BPRS total , BPRS core items , CGI-S , and PANSS negative subscale scores ( p < .05 ) . Ziprasidone 160 mg/day significantly improved depressive symptoms in patients with clinical ly significant depression at baseline ( MADRS ≥ 14 , over-all mean 23.5 ) ( p < .05 ) as compared with placebo . The percentage of patients experiencing adverse events was similar in each treatment group , and result ant discontinuation was rare . The most frequent adverse events associated with ziprasidone were generally mild dyspepsia , nausea , dizziness , and transient somnolence . Ziprasidone was shown to have a very low liability for inducing movement disorders and weight gain . The results indicate that ziprasidone is effective and well tolerated in the treatment of the positive , negative , and depressive symptoms of an acute exacerbation of schizophrenia or schizoaffective disorder 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 AIMS To assess the potential of ziprasidone to alter the renal clearance and steady-state serum levels of lithium . METHODS Healthy subjects who had stable serum lithium levels during the first 7 days of treatment with lithium 900 mg day(-1 ) , given as two divided daily doses , were r and omized to receive concomitant treatment with either ziprasidone , 40 mg day(-1 ) , given as two divided daily doses , on days 9 - 11 followed by 80 mg day(-1 ) , given as two divided daily doses on days 12 - 15 ( n = 12 ) , or placebo twice daily ( n = 13 ) . Ziprasidone or placebo was administered 2 h before each dose of lithium . RESULTS Ziprasidone administration was associated with a 0.07 mmol l(-1 ) ( 13 % ) mean increase in steady-state serum lithium levels compared with a mean increase of 0.06 mmol l(-1 ) ( 10 % ) with placebo . Mean renal clearance of lithium decreased by 0.09 l h(-1 ) ( 5 % ) in the ziprasidone group and by 0.14 l h(-1 ) ( 9 % ) in the placebo group . None of these differences between the two groups was statistically or clinical ly significant . CONCLUSIONS Ziprasidone does not alter steady-state serum lithium concentrations or renal clearance of lithium BACKGROUND Ziprasidone is a novel antipsychotic with a unique pharmacologic profile . This study compared ziprasidone with the conventional antipsychotic haloperidol in out patients with stable schizophrenia . METHOD Three hundred one out patients with stable chronic or subchronic schizophrenia ( DSM-III-R ) were r and omized and participated in this double-blind , multicenter , parallel-group clinical study comparing flexible-dose oral ziprasidone , 80 - 160 mg/day ( N = 148 ) , with haloperidol , 5 - 15 mg/day ( N = 153 ) , over 28 weeks . Patients were assessed using the Positive and Negative Syndrome Scale ( PANSS ) , the Clinical Global Impressions-Severity of Illness scale , the Montgomery-Asberg Depression Rating Scale , the Simpson-Angus Scale , the Barnes Akathisia Scale , and the Abnormal Involuntary Movement Scale . RESULTS Modal doses at endpoint were 80 mg/day for ziprasidone and 5 mg/day for haloperidol . Improvements in all mean efficacy variables with both ziprasidone and haloperidol were observed . Significantly more patients were categorized as negative symptom responders ( > or = 20 % reduction in PANSS negative subscale score ) in the ziprasidone group ( 48 % ) compared with the haloperidol group ( 33 % ) ( p < .05 ) . Ziprasidone had clear advantages over haloperidol in all evaluations of movement disorders . Changes in body weight were negligible with both treatments . No pattern of laboratory or cardiovascular changes was observed . CONCLUSION Ziprasidone and haloperidol were both effective in reducing overall psychopathology ; ziprasidone demonstrated effective treatment of negative symptoms and was better tolerated than haloperidol . Ziprasidone appears to offer an effective alternative to haloperidol in the long-term treatment of stable out patients with schizophrenia Ninety patients with schizophrenia or schizoaffective disorder according to DSM-III-R criteria participated in this double-blind , exploratory , dose-ranging trial . After a single-blind washout period of 4 to 7 days , patients were r and omly assigned to receive one of four fixed doses of the new antipsychotic , ziprasidone 4 ( N = 19 ) , 10 ( N = 17 ) , 40 ( N = 17 ) , or 160 ( N = 20 ) mg/day or haloperidol 15 mg/day ( N = 17 ) for 4 weeks . A dose-response relationship among ziprasidone groups was established for improvements in Clinical Global Impression Severity ( CGI-S ) score ( p = 0.002 ) but not in Brief Psychiatric Rating Scale ( BPRS ) total score ( p = 0.08 ) . The intent-to-treat analysis of mean changes from baseline in the BPRS total , BPRS Psychosis core , and CGI-S scores demonstrated that ziprasidone 160 mg/day was comparable with haloperidol in reducing overall psychopathology and positive symptoms and was superior to ziprasidone 4 mg/day . Despite the small sample size and short duration of the trial , the improvement in CGI-S with both ziprasidone 160 mg/day and haloperidol 15 mg/day was statistically significantly greater than with ziprasidone 4 mg/day ( p = 0.001 and p = 0.005 , respectively ) . The percentage of patients classified as responders on both the BPRS total ( > or = 30 % improvement ) and CGI-Improvement ( score of 1 or 2 ) scales in the ziprasidone 160 mg/day group was similar to that in the haloperidol group and nonsignificantly greater than that in the ziprasidone 4 mg/day group . On all assessment s of clinical efficacy , the improvements associated with ziprasidone 4 mg/day , 10 mg/day , and 40 mg/day were similar . Concomitant benztropine use at any time during the study was less frequent with ziprasidone 160 mg/day ( 15 % ) than with haloperidol ( 53 % ) . Haloperidol was associated with a sustained hyperprolactinemia , unlike ziprasidone , where only transient elevations in prolactin that returned to normal within the dosing interval were observed . Ziprasidone was well tolerated , and the incidence of adverse events was similar in all groups . The results of this study suggest that ziprasidone 160 mg/day is as effective as haloperidol 15 mg/day in reducing overall psychopathology and positive symptoms of an acute exacerbation of schizophrenia or schizoaffective disorder but has a lower potential to induce extrapyramidal symptoms A modification of an earlier rating scale for extrapyramidal system disturbance is described , and evidence for the validity and reliability of the scale is presented . The usefulness of the scale in studies of neuroleptic drugs is discussed . By its application it is possible to quantify extrapyramidal side effects and to separate them into four principal factors
Output:
| Ziprasidone may be an effective antipsychotic with less extrapyramidal effects than haloperidol .
It also , however , causes more nausea and vomiting than the typical drugs , and , at present , there is no data suggesting that it is different to other atypical compounds . |
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