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MS211800 | ***TASK*** the task is to summarize an input biomedical literature 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 Alzheimer ’s disease ( AD ) is the most common cause of dementia . However , none of medical treatment can stop or reverse the underlying neurodegenerative of AD at present . Acupuncture has attracted more and more attention in recent years due to its efficacy and very few side effects . Lately , a systematic review has thought that the evidence on the effectiveness of acupuncture in improving the cognitive function of AD patients was not powerful enough . Therefore , the aim of this study is to explore the efficacy and safety of acupuncture in patients with mild to moderate AD . Methods This was a r and omized , controlled , parallel-group , exploratory study with 4-week baseline ( T0 ) , 12-week treatment phase ( T1 ) and 12-week follow-up period ( T2 ) . Patients with mild to moderate AD meeting the included criteria were r and omly allocated into either acupuncture or donepezil hydrochloride groups . The acupuncture group(AG ) was given acupuncture treatment three times per week and the donepezil hydrochloride group(DG ) group was administered donepezil hydrochloride once daily ( 5 mg/day for the first 4 weeks and 10 mg/day thereafter ) . Primary efficacy was measured using Alzheimer ’s disease Assessment Scale-Cognitive ( ADAS-cog ) and Clinician ’s Interview-Based Impression of Change-Plus ( CIBIC-Plus ) . The second outcomes were measured with 23-Item Alzheimer ’s disease Cooperative Study Activities of Daily Living Scales ( ADAS-ADL23 ) and Neuropsychiatric Index ( NPI ) . Results Of 87 participants enrolled in the study , 79 patients finished their treatment and follow-up processes . The ADAS-cog scores for AG group showed obvious decreases at T2 and ∆(T2-T0)when compared with DG group , and significant between-group differences were detected ( all p < 0.05 ) . The mean CIBIC-Plus values for the AG group at T1 and T2 were much lower than that for the DG group , and there were significant differences between the two groups ( 푃<0.05 ) . There were no significant between-group differences in the scores of ADAS-ADL23 and NPI during the study period . Treatment discontinuations due to adverse events were 0 ( 0 % ) and 4 ( 9.09 % ) for the AG and DG groups , respectively . Conclusions Acupuncture is safe , well tolerated and effective in improving the cognitive function , global clinical status of AD.Trial Registration ChiCTR-IOR-17010465 ( Retroactively registered on 18 JAN 2017 ) Background Alzheimer ’s disease is a progressive neurodegenerative disease . Although some of the current treatments offer some symptomatic relief , this disease can not be cured at present . Electroacupuncture may be effective for Alzheimer ’s disease for cognitive function , but the evidence for its effectiveness is still limited . The aim of this study is to evaluate the add-on effect of electroacupuncture to donepezil for improving the cognitive function of Alzheimer ’s disease . Methods / design A total of 334 participants with Alzheimer ’s disease will be r and omly assigned to either an electroacupuncture combined with donepezil group or a donepezil group with a ratio of 1:1 . Participants in the electroacupuncture combined with donepezil group will receive electroacupuncture in addition to donepezil for 12 weeks and will keep taking donepezil for the following 24 weeks . Participants in the control group will take donepezil only . The primary outcome is the change from baseline in the total score of the Alzheimer ’s Disease Assessment Scale-cognition at week 12 . A follow-up will be conducted 24 weeks after the treatment . Discussion We expect to verify the hypothesis that acupuncture in addition to donepezil is better than donepezil in improving the cognitive function of patients with Alzheimer ’s disease . This trial has a limitation that participant blinding is impossible . Trial registration Clinical Trials.gov : ID : NCT02305836 . Registered on 13 November 2014 BACKGROUND / OBJECTIVE Balance problems are common in older adults with Alzheimer 's disease ( AD ) . The objective was to study the effects of a Wii-Fit interactive video-game-led physical exercise program to a walking program on measures of balance in older adults with mild AD . METHODS A prospect i ve r and omized controlled parallel-group trial ( Wii-Fit versus walking ) was conducted in thirty community-dwelling older adults ( 73±6.2 years ) with mild AD . Home-based exercises were performed under caregiver supervision for 8 weeks . Primary ( Berg Balance Scale , BBS ) and secondary outcomes ( fear of falls and quality of life ) were measured at baseline , 8 weeks ( end of intervention ) , and 16 weeks ( 8-weeks post-intervention ) . RESULTS At 8 weeks , there was a significantly greater improvement ( average inter-group difference [ 95 % CI ] ) in the Wii-Fit group compared to the walking group in BBS ( 4.8 [ 3.3 - 6.2 ] , p < 0.001 ) , after adjusting for baseline . This improvement was sustained at 16 weeks ( 3.5 [ 2.0 - 5.0 ] , p < 0.001 ) . Analyses of the secondary outcome measures indicated that there was a significantly greater improvement in the Wii-Fit group compared to walking group in Activity-specific Balance Confidence scale ( 6.5 [ 3.6 - 9.4 ] , p < 0.001 ) and Falls Efficacy Scale ( -4.8 [ -7.6 to -2.0 ] , p = 0.002 ) at 8 weeks . However , this effect was not sustained at 16 weeks . Quality of life improved in both groups at 8 weeks ; however , there were no inter-group differences ( p = 0.445 ) . CONCLUSION Home-based , caregiver-supervised Wii-Fit exercises improve balance and may reduce fear of falling in community-dwelling older adults with mild AD Background : This study explored the feasible efficacy and safety of the Spore Powder of Ganoderma Lucidum ( SPGL ) for treating patients with Alzheimer disease ( AD ) . Methods : Forty-two eligible patients with AD were recruited . These patients were r and omly allocated to an intervention group and a control group equally . The patients in the intervention group underwent SPGL , whereas the subjects in the control received placebo . All patients were treated for a total of 6 weeks . The primary outcome was measured by Alzheimer 's disease Assessment Scale-Cognitive ( ADAS-cog ) . The secondary outcomes were measured by the World Health Organization Quality of Life question naire ( WHOQOL-BREF ) and Neuropsychiatric Index ( NPI ) . The adverse events were also recorded during the treatment period . Results : At the end of the treatment , GLSP did not show more encouraging outcomes in symptoms improvement , measured by the ADAS-cog ( P = .31 ) , and NPI ( P = .79 ) ; and quality of life enhancement , measured by the WHOQOL-BREF ( physical , P = .62 ; psychological , P = .69 ; social relationships , P = .75 ; environment , P = .82 ; overall quality of life , P = .74 ) , compared with the control group . In addition , all adverse events were mild , and no significant differences were found between 2 groups . Conclusion : The results of this study did not find the promising efficacy of SPGL for the treatment of AD after 6-week treatment . It may be because of the relative short-term of intervention . Future clinical trials with larger sample size and longer treatment period are urgently needed BACKGROUND Alzheimer 's disease is characterized by the deposition of amyloid‐beta ( Aβ ) plaques in the brain . Aβ is produced from the sequential cleavage of amyloid precursor protein by β‐site amyloid precursor protein – cleaving enzyme 1 ( BACE‐1 ) followed by γ‐secretase . Verubecestat is an oral BACE‐1 inhibitor that reduces the Aβ level in the cerebrospinal fluid of patients with Alzheimer 's disease . METHODS We conducted a r and omized , double‐blind , placebo‐controlled , 78‐week trial to evaluate verubecestat at doses of 12 mg and 40 mg per day , as compared with placebo , in patients who had a clinical diagnosis of mild‐to‐moderate Alzheimer 's disease . The co primary outcomes were the change from baseline to week 78 in the score on the cognitive subscale of the Alzheimer 's Disease Assessment Scale ( ADAS‐cog ; scores range from 0 to 70 , with higher scores indicating worse dementia ) and in the score on the Alzheimer 's Disease Cooperative Study Activities of Daily Living Inventory scale ( ADCS‐ADL ; scores range from 0 to 78 , with lower scores indicating worse function ) . RESULTS A total of 1958 patients underwent r and omization ; 653 were r and omly assigned to receive verubecestat at a dose of 12 mg per day ( the 12‐mg group ) , 652 to receive verubecestat at a dose of 40 mg per day ( the 40‐mg group ) , and 653 to receive matching placebo . The trial was terminated early for futility 50 months after onset , which was within 5 months before its scheduled completion , and after enrollment of the planned 1958 patients was complete . The estimated mean change from baseline to week 78 in the ADAS‐cog score was 7.9 in the 12‐mg group , 8.0 in the 40‐mg group , and 7.7 in the placebo group ( P=0.63 for the comparison between the 12‐mg group and the placebo group and P=0.46 for the comparison between the 40‐mg group and the placebo group ) . The estimated mean change from baseline to week 78 in the ADCS‐ADL score was ‐8.4 in the 12‐mg group , ‐8.2 in the 40‐mg group , and ‐8.9 in the placebo group ( P=0.49 for the comparison between the 12‐mg group and the placebo group and P=0.32 for the comparison between the 40‐mg group and the placebo group ) . Adverse events , including rash , falls and injuries , sleep disturbance , suicidal ideation , weight loss , and hair‐color change , were more common in the verubecestat groups than in the placebo group . CONCLUSIONS Verubecestat did not reduce cognitive or functional decline in patients with mild‐to‐moderate Alzheimer 's disease and was associated with treatment‐related adverse events . ( Funded by Merck ; Clinical Trials.gov number , NCT01739348 . Objectives To explore the cost-effectiveness of a supervised moderate-to-high intensity aerobic exercise programme in people diagnosed with Alzheimer ’s disease ( AD ) and estimate incremental cost-effectiveness ratios ( ICER ) using participant-reported and proxy-reported measures of health-related quality of life ( HRQoL ) Design A cost-effectiveness analysis of economic and HRQoL data from a r and omised trial delivered over 16 weeks . Setting Memory clinics in Denmark . Participants 200 individuals with mild AD aged 50–90 years gave informed consent to participate in the study . Participants were r and omised to control or intervention group . Interventions Control group received treatment as usual . The intervention group performed 1 hour of supervised moderate-to-high intensity aerobic exercise three times weekly for 16 weeks . Primary and secondary outcomes measures Different physical , functional and health measures were obtained at inclusion ( baseline ) and 4 and 16 weeks after . HRQoL ( EuroQol-5 Dimensions-5 Levels/EQ-Visual Analogue Scale ) was reported by the participants and the primary caregivers as proxy respondents . Differences in HRQOL as reported by the participant and caregiver were explored as were different values of caregiver time with respite from care tasks . Results The intervention cost was estimated at € 608 and € 496 per participant , with and without transport cost , respectively . Participants and caregivers in the intervention group reported a small , positive non-significant improvement in EQ-5D-5L and EQ-VAS after 16 weeks . The ICER was estimated at € 72 000/ quality -adjusted life year using participant-reported outcomes and € 87000 using caregiver-reported outcomes . Conclusions The findings suggest that the exercise intervention is unlikely to be cost-effective within the commonly applied threshold values . The cost of the intervention might be offset by potential savings from reduction in use of health and social care . Trial registration number https:// clinical trials.gov/ct2/show/NCT01681602 BACKGROUND Alzheimer 's disease is characterized by amyloid‐beta ( Aβ ) plaques and neurofibrillary tangles . The humanized monoclonal antibody solanezumab was design ed to increase the clearance from the brain of soluble Aβ , peptides that may lead to toxic effects in the synapses and precede the deposition of fibrillary amyloid . METHODS We conducted a double‐blind , placebo‐controlled , phase 3 trial involving patients with mild dementia due to Alzheimer 's disease , defined as a Mini – Mental State Examination ( MMSE ) score of 20 to 26 ( on a scale from 0 to 30 , with higher scores indicating better cognition ) and with amyloid deposition shown by means of florbetapir positron‐emission
Output:
| Conclusions : This systematic review will present the existing evidence for the efficacy and safety of SPGL for treating patients with AD . |
MS211801 | ***TASK*** the task is to summarize an input biomedical literature 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 Outcome measurement following surgery is increasingly the focus of attention in current health-care debates because of the rising costs of medical care and the large variety of operative options . The purpose of the present study was to correlate quality of life after volar locked plate fixation of unstable intra-articular distal radial fractures with functional and radiographic results as well as with quality -of-life data from population norms . METHODS Fifty-four consecutive patients with intra-articular distal radial fractures and a mean age of sixty-three years were managed with a volar locked plate system . Range of motion , grip strength , and radiographs were assessed at a mean of six years postoperatively . The wrist-scoring systems of Gartl and and Werley and Castaing were adopted for the assessment of objective outcomes . The Disabilities of the Arm , Shoulder and H and and Short Form-36 question naires were completed as subjective outcome measures , and the results were compared with United States and Austrian population norms . RESULTS Functional improvement continued for two years postoperatively . At the time of the latest follow-up , > 90 % of all patients had achieved good or excellent results according to the scoring systems of Gartl and and Werley and Castaing . The results of the Short Form-36 question naire were similar to the United States and Austrian population norms . The mean Disabilities of the Arm , Shoulder and H and score was 5 points at two years , and it increased to 13 points at six years . The twenty patients with radiocarpal arthritis had significantly poorer results in the physical component summary measure of the Short Form-36 question naire ( p = 0.012 ) . CONCLUSIONS The results of the present single-center study show that , following distal radial fracture fixation , wrist arthritis may affect the patient 's subjective well-being , as documented with the Short Form-36 , without influencing the functional outcome . Well- design ed longitudinal clinical trials are needed to confirm the findings of the present investigation in terms of quality of life after surgical treatment of intra-articular distal radial fractures Different methods exist to treat distal radius fractures . A prospect i ve r and omized study was conducted to establish whether palmar plate fixation with locking screws gave better results than percutaneous K-wire fixation in patients over 50 years of age . Only fractures with dorsal displacement after a simple fall were included in the study . Twenty wrists were treated with K-wires and 20 with a plate . Radiological parameters were measured on preoperative radiographs and at five weeks postoperatively . Clinical results and DASH scores were determined at three months postoperatively and at more than one year . No significant difference in radial inclination , palmar tilt , clinical outcome and DASH score was found between plating and K-wires , but the mean difference in ulnar variance between pre- and postoperative radiographs was significantly better with plates . It can be concluded that plates were superior to K-wires in restoring ulnar variance , but functional outcome was similar with both techniques INTRODUCTION Malunion following open reduction and internal fixation of distal radius fracture threatens wrist function . Fixed-angle palmar plates provide rigid fixation that is stable over time ; however , the pronator quadratus sectioning required by the anterior approach entails a risk of pronation strength loss and of distal radioulnar joint destabilization . The present study assessed recovery of grip , pronation and supination strength following such internal fixation . PATIENTS AND METHOD A prospect i ve study included 26 distal radial fractures with dorsal displacement , osteosynthesized using a fixed-angle palmar plate , in 25 patients ( mean age : 47.5 years ; range : 17 - 72 years ) . Assessment concerned the classical parameters , plus grip and pronosupination strength recovery . RESULTS At a mean 14 months follow-up ( range : 6 - 30 months ) , patients had recovered 91 % grip strength , 88 % pronation strength and 85 % supination strength with respect to the healthy side . Complications comprised three cases of malunion , two of reflex sympathetic dystrophy syndrome , and four of post-traumatic carpal tunnel syndrome . DISCUSSION A study of the literature found 75 - 95 % grip strength recovery following osteo synthesis using fixed-angle plates . Few studies , however , have focused on pronosupination strength , and none reported its evolution following osteo synthesis . CONCLUSION The present study found no drawbacks associated with a technique which usually involves sectioning the pronator quadratus . Except in case of malunion or joint stiffness , fixed-angle palmar plate osteo synthesis was followed by recovery of grip and pronosupination strength . LEVEL OF EVIDENCE Level IV : prospect i ve non-r and omized , non-comparative observational study PURPOSE To compare minimally invasive intramedullary nails ( IMN ) and volar locking plates ( VLP ) for the treatment of unstable distal radius fractures by evaluating postoperative subjective , radiographic , and functional outcomes . The hypothesis was that IMN patients would have less pain and required less pain medication in the early postoperative period and returned to work earlier than VLP patients . METHODS Sixty patients with closed , displaced , unstable , extra-articular , metaphyseal fractures of the distal radius were r and omized to receive a VLP or an IMN for internal fixation . Functional outcomes ( Quick Disabilities of the Arm , Shoulder , and H and , Michigan H and Question naire ) , radiographic measurements ( ulnar variance , radial height , inclination , and volar tilt ) , and range of motion were assessed until final follow-up at 2 years after surgery . Narcotic pain medication use was documented for 5 weeks following surgery . RESULTS There were 2 groups of 30 patients with IMN ( mean age , 55 ± 14 y ) or VLP ( mean age , 55 ± 16 y ) with similar demographics and comorbidities . Patients with IMN regained extension earlier but had similar range of motion to patients with VLP at final follow-up . There was similar improvement in Michigan H and Question naire , Quick Disabilities of the Arm , Shoulder , and H and , and strength between groups . Five weeks after surgery , fewer IMN patients required narcotic pain medication ( 13 % ) than VLP patients ( 33 % ) . Radiographic outcomes were similar at final follow-up . There were 3 failures with IMN versus 1 failure with VLP . All 10 employed patients with IMN returned to previous work compared with 10 of the 12 employed patients with VLP . Time to return to work was similar for both groups . CONCLUSIONS In a cohort of similar patients , IMN and VLP provided comparable improvement in functional and radiographic outcomes . Patients with IMN required less narcotic pain medication after surgery than VLP patients . TYPE OF STUDY /LEVEL OF EVIDENCE Therapeutic II ABSTRACT The purpose of this study was to determine whether volar locking plate fixation for distal radius fracture benefits the fragility fracture population as much as it benefits the non-fragility fracture population . This matched case-control study was conducted based on a multi-center clinical prospect i ve cohort . A comparison of treatment outcomes after volar locking plate fixation was made between females 55 years of age and older ( fragility fracture population ) and males less than 75 years of age ( non-fragility fracture population ) by evaluating clinical , radiological , and subjective outcomes using H and 20 , a vali date d patient-rated disability instrument . A total of 170 patients were enrolled in this study . The two cohorts were matched in terms of AO fracture type . The fragility fracture population group and the non-fragility fracture population group each consisted of 50 patients . All objective measurements including wrist range of motion and radiological evaluations , but excluding grip strength , were not significantly different between the two groups . However , the H and 20 at 18 months after surgery was worse in the fragility fracture population group than in the non-fragility fracture population group . Carpal tunnel syndrome was the most frequently encountered complication in the fragility fracture population group , with one case ( 2 % ) in the non-fragility fracture population group and six cases ( 12 % ) in the fragility fracture population group , but the difference was not significant . In conclusion , there was a significant deficit in the improvement in disability despite favorable radiological and functional outcomes in fragility fracture population patients . Therefore , the fragility fracture population , especially middle-aged or older women , needs to be informed about prolonged disability and the higher risk of upper extremity disorders prior to surgery Objectives : The purpose of this study was to compare the postoperative radiologic and clinical outcomes of conventional plate osteo synthesis ( C ) with minimally invasive plate osteo synthesis ( M ) using a transverse skin incision without cutting the pronator quadratus muscle for distal radius fractures . Design : Retrospective consecutive cohort with prospect i ve data collection . Setting : One community teaching hospital . Surgical treatment was performed by a single surgeon . Patients : Sixty-six patients ( C group , 36 ; M group , 30 ) underwent open reduction and internal fixation of dorsally displaced distal radius fractures with the volar locking plating system from June 2006 to August 2008 . Their mean age was 63.5 years and the mean follow-up period was 22.7 months . Main Outcome Measures : Radiologic parameters ( volar tilt , radial inclination , ulnar variance ) , range of motion , grip strength , and Disability of the Arm , Shoulder , and H and score were evaluated at each examination . The visual analog scale of wrist pain and evaluations of cosmetic problems were assessed at the final follow-up . Results : The groups did not differ significantly in all main outcomes . In the M group , the mean values of the Disability of the Arm , Shoulder , and H and score at 2 weeks postoperatively ( P = 0.06 ) and visual analog scale ( P = 0.07 ) were lower and the mean value of the patient 's satisfaction score of cosmetic problems ( P = 0.08 ) was higher than those in the C group , but no statistically significant differences were apparent in these values . Conclusion : No significant differences were found between the minimally invasive plate osteo synthesis and conventional plating for distal radius fractures based on the data from postoperative radiologic and clinical outcomes Background Current surgical approaches to the distal radius include dorsal and palmar plate fixation . While palmar plates have gained widespread popularity , few reports have provided data on long term clinical outcomes in comparison . This paper reports the result of a r and omised clinical study comparing dorsal Pi plates and palmar , angle-stable plates for treatment of comminuted , intraarticular fractures of the distal radius over the course of twelve months . Methods 42 patients with unilateral , intraarticular fractures of the distal radius were included and r and omised to 2 groups , 22 were treated with a palmar plate , 20 received a dorsal Pi-plate . Results were evaluated after 6 weeks , 3 , 6 and 12 months postoperatively focussing on functional recovery as well as radiological results . Results The palmar plate group demonstrated significantly better results regarding range of motion and grip strength over the course of 12 months . While a comparable increase in function was observed in both groups , the better results from the early postoperative period in the palmar plate group prevailed over the whole course . Radiological results showed a significantly increased palmar tilt and carpal sag in dorsal plates , with other radiological parameters being comparable . Pain levels were decreased in dorsal plates after hardware removal and failed to show significant differences after 12 months . However , complications such as tendon ruptures were more frequent in the dorsal plate group . Conclusions Functional advantage of palmar plates gained within the first 6 weeks prevails over the course of a year . Both groups demonstrate further gradual increase of function after 6 months , although dorsal plates did not catch up completely . Improved early postoperative function seems to be the cornerstone for the best possible results . Patients with dorsal plates benefit from hardware removal more than palmar plates in terms of reduction of pain levels . The advantage of palmar plates is a faster functional recovery with lower complication rates . This is especially important in the elderly population . Radiological results did not show a superiority of palmar plates over dorsal plates Introduction : Distal radius fracture ( DRF ) is a common injury and various treatment modalities including open reduction and internal fixation ( ORIF ) with volar locking plate are available . More recently , a non-invasive external fixator has been used . Aims : To prospect ively compare the use of a non-invasive external fixator with early dynamisation for DRF against ORIF with volar locking plate control group . Methods : Consecutive patients with closed DRF were included in a prospect i ve case-controlled study . Patients were assigned to non-invasive external fixator or ORIF . Minimum follow-up was two years . Follow-up was at weeks 2 , 4 , 6 , 8 , 12 , 26 and at one and two-year post-operatively . The outcome measures included demographic details , injury mechanism , AO fracture type , risk factors , body mass index ( BMI ) , ulnar styloid fracture and dorsal comminution , radiographs , grip strength and DASH score . Results : Consecutive 50 patients were treated either with non-invasive external fixator ( 25/50 ) or with ORIF ( 25/50 ) and the mean age of the two groups was 53 years ( SD 17.1 ) and 49 years ( SD 19.5 ) , respectively . Demographics were matched in two groups . In the non-invasive external fixator group , there were 10 AO Type-A , 5 Type-B and 10 Type-C fractures . The ORIF group included 8 Type-A , 6 Type-B and 11 Type-C fractures . The mean DASH score at three-months and one-
Output:
| There was a diversity of removal rate and reasons in the studies over the world .
High frequent VLP removal did not contribute to better clinical outcomes |
MS211802 | ***TASK*** the task is to summarize an input biomedical literature 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 Few studies have explored the relationship between weight bias and weight loss treatment outcomes . Purpose This investigation examined the relationship between implicit and explicit weight bias and ( a ) program attrition , ( b ) weight loss , ( c ) self-monitoring adherence , ( d ) daily exercise levels and overall caloric expenditure , ( e ) daily caloric intake , and ( f ) daily caloric deficit among overweight/obese treatment-seeking adults . Methods Forty-six overweight/obese adults ( body mass index ≥ 27 kg/m2 ) participating in an 18-week , stepped-care , behavioral weight loss program completed implicit and explicit measures of weight bias . Participants were instructed to self-monitor and electronically report daily energy intake , exercise , and energy expenditure . Results Greater weight bias was associated with inconsistent self-monitoring , greater caloric intake , lower energy expenditure and exercise , creation of a smaller caloric deficit , higher program attrition , as well as less weight loss during the self-help phase of the stepped-care treatment . Conclusions Weight bias may interfere with overweight/obese treatment-seeking adults ' ability to achieve optimal health An implicit association test ( IAT ) measures differential association of 2 target concepts with an attribute . The 2 concepts appear in a 2-choice task ( 2-choice task ( e.g. , flower vs. insect names ) , and the attribute in a 2nd task ( e.g. , pleasant vs. unpleasant words for an evaluation attribute ) . When instructions oblige highly associated categories ( e.g. , flower + pleasant ) to share a response key , performance is faster than when less associated categories ( e.g. , insect & pleasant ) share a key . This performance difference implicitly measures differential association of the 2 concepts with the attribute . In 3 experiments , the IAT was sensitive to ( a ) near-universal evaluative differences ( e.g. , flower vs. insect ) , ( b ) expected individual differences in evaluative associations ( Japanese + pleasant vs. Korean + pleasant for Japanese vs. Korean subjects ) , and ( c ) consciously disavowed evaluative differences ( Black + pleasant vs. White + pleasant for self-described unprejudiced White subjects )
Output:
| Weight stigma was positively associated with obesity , diabetes risk , cortisol level , oxidative stress level , C-reactive protein level , eating disturbances , depression , anxiety , body image dissatisfaction and negatively associated with self-esteem among overweight and obese adults .
Weight stigma is associated with adverse physiological and psychological outcomes . |
MS211803 | ***TASK*** the task is to summarize an input biomedical literature 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 Despite the increasing breast cancer incidence and mortality rates , Korean American immigrant women have one of the lowest rates of breast cancer screening across racial groups in the United States . Mobile health ( mHealth ) , defined as the delivery of health care information or services through mobile communication devices , has been utilized to successfully improve a variety of health outcomes . Objective This study adapted the principles of mHealth to advance breast cancer prevention efforts among Korean American immigrant women , an underserved community . Methods Using a r and omized controlled trial design , 120 Korean American women aged 40 to 77 years were recruited and r and omly assigned to either the mMammogram intervention group ( n=60 ) to receive culturally and personally tailored multilevel and multimedia messages through a mobile phone app along with health navigator services or the usual care control group ( n=60 ) to receive a printed brochure . Outcome measures included knowledge , attitudes , and beliefs about breast cancer screening , readiness for mammography , and mammogram receipt . The feasibility and acceptability of the mMammogram intervention was also assessed . Results The intervention group showed significantly greater change on scores of knowledge of breast cancer and screening guidelines ( P=.01 ) . The intervention group also showed significantly greater readiness for mammography use after the intervention compared with the control group . A significantly higher proportion of women who received the mMammogram intervention ( 75 % , 45/60 ) completed mammograms by the 6-month follow-up compared with the control group ( 30 % , 18/60 ; P<.001 ) . In addition , the intervention group rated satisfaction with the intervention ( P=.003 ) , effectiveness of the intervention ( P<.001 ) , and increase of knowledge on breast cancer and screenings ( P=.001 ) significantly higher than the control group . Conclusions A mobile phone app – based intervention combined with health navigator service was a feasible , acceptable , and effective intervention mechanism to promote breast cancer screening in Korean American immigrant women . A flexible , easily tailored approach that relies on recent technological advancements can reach underserved and hard-to-recruit population s that bear disproportionate cancer burdens . Trial Registration Clinical trials.gov NCT01972048 ; https:// clinical trials.gov/show/NCT01972048 ( Archived by WebCite at https:// clinical trials.gov/archive/NCT01972048/2013_10_29 The progressive nature of Parkinson ’s disease , its complex treatment regimens and the high rates of comorbid conditions make self-management and treatment adherence a challenge . Clinicians have limited face-to-face consultation time with Parkinson ’s disease patients , making it difficult to comprehensively address non-adherence . Here we share the results from a multi-centre ( seven centres ) r and omised controlled trial conducted in Engl and and Scotl and to assess the impact of using a smartphone-based Parkinson ’s tracker app to promote patient self-management , enhance treatment adherence and quality of clinical consultation . Eligible Parkinson ’s disease patients were r and omised using a 1:1 ratio according to a computer-generated r and om sequence , stratified by centre and using blocks of variable size , to intervention Parkinson ’s Tracker App or control ( Treatment as Usual ) . Primary outcome was the self-reported score of adherence to treatment ( Morisky medication adherence scale −8 ) at 16 weeks . Secondary outcomes were Quality of Life ( Parkinson ’s disease question naire −39 ) , quality of consultation for Parkinson ’s disease patients ( Patient-centred question naire for Parkinson ’s disease ) , impact on non-motor symptoms ( Non-motor symptoms question naire ) , depression and anxiety ( Hospital anxiety and depression scale ) and beliefs about medication ( Beliefs about Medication Question naire ) at 16 weeks . Primary and secondary endpoints were analysed using a generalised linear model with treatment as the fixed effect and baseline measurement as the covariate . 158 patients completed the study ( Parkinson ’s tracker app = 68 and TAU = 90 ) . At 16 weeks Parkinson ’s tracker app significantly improved adherence , compared to treatment as usual ( mean difference : 0.39 , 95%CI 0.04–0.74 ; p = 0.0304 ) with no confounding effects of gender , number of comorbidities and age . Among secondary outcomes , Parkinson ’s tracker app significantly improved patients ’ perception of quality of consultation ( 0.15 , 95 % CI 0.03 to 0.27 ; p = 0.0110 ) . The change in non-motor symptoms was −0.82 ( 95 % CI −1.75 to 0.10 ; p = 0.0822 ) . 72 % of participants in the Parkinson ’s tracker app group continued to use and engage with the application throughout the 16-week trial period . The Parkinson ’s tracker app can be an effective and novel way of enhancing self-reported medication adherence and quality of clinical consultation by supporting self-management in Parkinson ’s disease in patients owning smartphones . Further work is recommended to determine whether the benefits of the intervention are maintained beyond the 16 week study period . Digital healthcare : App helps patients stick to planA smartphone-based application improves treatment adherence of patients with Parkinson ’s disease ( PD ) . Rashmi Lakshminarayana , from uMotif Ltd , and research ers from the UK and The Netherl and s describe the results of a 16 week trial of a Parkinson ’s tracker app ( PTA ) that r and omised 215 patients from seven different health centres . Patients using the app reported significantly better adherence to their medication plan compared with control patients who continued their treatment as usual . Interestingly , using the PTA also improved the patients ’ perception of the quality of their clinical care , possibly as a result of feeling more involved and in control of their care . These findings suggest that by sending medication reminders and tracking symptoms , the app can help patients with Parkinson ’s self-manage their increasingly complex treatment regimen as the disease progresses Background : Little is known about the benefits of social networks in the management of patients . Objective : The aim of this study was to compare the effects of self-management ( SM ) education using telephone follow-up and mobile phone-based social networking on SM behaviors among patients with hypertension . Methods : This r and omized clinical trial was conducted with 100 patients . They were r and omly allocated to four groups : ( i ) control , ( ii ) SM training without follow-up , ( iii ) telephone follow-up and ( iv ) smartphone-based social networking follow-up . The hypertension SM behavior question naire was used for data collection before and six weeks after the study . Results : Those patients who underwent SM education training ( with and without follow-up ) had statistically significant differences from those in the control group in terms of SM behaviors ( p < .001 ) . There was no statistically significant difference between different types of follow-up . Conclusion : SM education using telephone follow-up and /or smartphone-based social networking follow-up influenced SM behaviors among patients with hypertension Background Many preventable behaviors contribute to adolescent mortality and morbidity . Non-adherence to preventive measures represents a challenge and has been associated with worse health outcomes in this population . The widespread use of electronic communication technologies by adolescents , particularly the use of text messaging ( short message service , SMS ) and mobile phones , presents new opportunities to intervene on risk and preventive risk behavior , but little is known about their efficacy . Objective This study aim ed to systematic ally evaluate evidence for the efficacy of text messaging and mobile phone app interventions to improve adherence to preventive behavior among adolescents and describe intervention approaches to inform intervention development . Methods This review covers literature published between 1995 and 2015 . Search es included PubMed , Embase , CENTRAL , PsycINFO , CINAHL , INSPEC , Web of Science , Google Scholar , and additional data bases . The search strategy sought articles on text messaging and mobile phone apps combined with adherence or compliance , and adolescents and youth . An additional h and search of related themes in the Journal of Medical Internet Research was also conducted . Two review ers independently screened titles and abstract s , assessed full-text articles , and extracted data from articles that met inclusion criteria . Included studies reflect original research —experimental or preexperimental design s with text messaging or mobile phone app interventions —targeting adherence to preventive behavior among adolescents ( 12 - 24 years old ) . The preferred reporting items of systematic review s and meta-analyses ( PRISMA ) guidelines were followed for reporting results , and findings were critically appraised against the Oxford Centre for Evidence -based Medicine criteria . Results Of 1454 records , 19 met inclusion criteria , including text messaging ( n=15 ) and mobile phone apps ( n=4 ) . Studies targeted clinic attendance , contraceptive use , oral health , physical activity and weight management , sun protection , human papillomavirus ( HPV ) vaccination , smoking cessation , and sexual health . Most studies were performed in the United States ( 47 % , 9/19 ) , included younger adolescents ( 63 % , 12/19 ) , and had sample size < 100 ( 63 % , 12/19 ) . Although most studies were r and omized controlled trials ( RCTs ; 58 % , 11/19 ) , only 5 followed an intent-to-treat analysis . Only 6 of 19 studies ( 32 % ) incorporated a theoretical framework in their design . Most studies reported good feasibility with high acceptability and satisfaction . About half of the included studies ( 42 % , 8/19 ) demonstrated significant improvement in preventive behavior with moderate st and ardized mean differences . As early efforts in this field to establish feasibility and initial efficacy , most studies were low to moderate in quality . Studies varied in sample size and methods of preventive behavior adherence or outcome assessment , which prohibited performing a meta- analysis . Conclusions Despite the promising feasibility and acceptability of text messaging and mobile phone apps in improving preventive behavior among adolescents , overall findings were modest in terms of efficacy . Further research evaluating the efficacy , effectiveness , and cost-effectiveness of these intervention approaches in promoting preventive behavior among adolescents is needed Purpose The purpose of this prospect i ve r and omized-controlled trial ( RCT ) was to evaluate if an app-based feedback-controlled active muscle training programme can be used to improve the outcome in the immediate postoperative period after total knee arthroplasty ( TKA ) . Methods Sixty patients , with a median age of 65.9 years ( range 45–84 ) , awaiting primary TKA were r and omized into a control and training group . Both groups followed an identical postoperative protocol . In addition , the training group postoperatively performed an app-based feedback-controlled active muscle training programme multiple times daily . Outcome measures were active and passive range of motion ( ROM ) , pain at rest and in motion , knee extension strength , the timed “ Up and Go ” , 10-m Walk Test , 30-s Chair St and Test , Knee Injury and Osteoarthritis Outcome Score ( KOOS ) , Knee Society Score ( KSS ) , and clinical data . Results The training group performed an average of 18.4 training sessions , which led to significantly higher ROM , less pain at rest and in motion , higher strength , and significantly higher functional scores . More training correlated with a better outcome . Conclusions The use of an app-based feedback-controlled active muscle training programme can improve the clinical outcome after TKA , especially ROM and reduce pain . Clinical ly relevant is that the training programme could be considered an alternative to continuous passive motion after total knee arthroplasty . Level of evidence II Background Modern health care focuses on shared decision making ( SDM ) because of its positive effects on patient satisfaction , therapy compliance , and outcomes . Patients ’ knowledge about their illness and available treatment options , gained through medical education , is one of the key drivers for SDM . Current patient education relies heavily on medical consultation and is known to be ineffective . Objective This study aim ed to determine whether providing patients with information in a subdivided , categorized , and interactive manner via an educational app for smartphone or tablet might increase the knowledge of their illness . Methods A surgeon-blinded r and omized controlled trial was conducted with 213 patients who were referred to 1 of the 6 Dutch hospitals by their general practitioner owing to knee complaints that were indicative of knee osteoarthritis . An interactive app that , in addition to st and ard care , actively sends informative and pertinent content to patients about their illness on a daily basis by means of push notifications in the week before their consultation . The primary outcome was the level of perceived and actual knowledge that patients had about their knee complaints and the relevant treatment options after the intervention . Results In total , 122 patients were enrolled in the control group and 91 in the intervention group . After the intervention , the level of actual knowledge ( measured on a 0 - 36 scale ) was 52 % higher in the app group ( 26.4 vs 17.4 , P<.001 ) . Moreover , within the app group , the level of perceived knowledge ( measured on a 0 - 25 scale ) increased by 22 % during the week within the app group ( from 13.5 to 16.5 , P<.001 ) , compared with no gain in the control group . Conclusions Actively offering patients information in a subdivided ( per day ) , categorized ( per theme ) , and interactive ( video and quiz questions ) manner significantly increases the level of perceived knowledge and demonstrates a higher level of actual knowledge , compared with st and ard care educational practice s. Trial Registration International St and ard R and omized Controlled Trial Number IS RCT N98629372 ; http://www.is rct n.com/IS RCT N98629372 ( Archived by WebCite at http://www.webcitation.org/73F5trZbb BACKGROUND AND AIM Getting ready for a colonos
Output:
| The interventions showed the highest effects on satisfaction with information , adherence to treatment instructions and to medication usage , clinical outcomes , and knowledge .
Conclusions This review demonstrates that educating patients with timely medical information through their smartphones or tablets improves their levels of knowledge , medication or treatment adherence , satisfaction , and clinical outcomes , as well as having a positive effect on health care economics .
These effects are most pronounced in interventions with a short duration ( ie , less than a month ) and with a high frequency of messages to patients ( ie , once per week or more ) . |
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Input: BACKGROUND Postoperative delirium and cognitive decline are common in elderly surgical patients after non-cardiac surgery . Despite this prevalence and clinical importance , no specific aetiological factor has been identified for postoperative delirium and cognitive decline . In experimental setting in a rat model , nitrous oxide ( N(2)O ) produces neurotoxic effect at high concentrations and in an age-dependent manner . Whether this neurotoxic response may be observed clinical ly has not been previously determined . We hypothesized that in the elderly patients undergoing non-cardiac surgery , exposure to N(2)O result ed in an increased incidence of postoperative delirium than would be expected for patients not receiving N(2)O. METHODS Patients who were > or=65 yr of age , undergoing non-cardiac surgery and requiring general anaesthesia were r and omized to receive an inhalational agent and either N(2)O with oxygen or oxygen alone . A structured interview was conducted before operation and for the first two postoperative days to determine the presence of delirium using the Confusion Assessment Method . RESULTS A total of 228 patients were studied with a mean ( range ) age of 73.9 ( 65 - 95 ) yr . After operation , 43.8 % of patients developed delirium . By multivariate logistic regression , age [ odds ratio ( OR ) 1.07 ; 95 % confidence interval ( CI ) 1.02 - 1.26 ] , dependence on performing one or more independent activities of daily living ( OR 1.54 ; 95 % CI 1.01 - 2.35 ) , use of patient-controlled analgesia for postoperative pain control ( OR 3.75 ; 95 % CI 1.27 - 11.01 ) and postoperative use of benzodiazepine ( OR 2.29 ; 95 % CI 1.21 - 4.36 ) were independently associated with an increased risk for postoperative delirium . In contrast , the use of N(2)O had no association with postoperative delirium . CONCLUSIONS Exposure to N(2)O result ed in an equal incidence of postoperative delirium when compared with no exposure to OBJECTIVES To determine whether donepezil hydrochloride can reduce the prevalence and severity of delirium in older adults undergoing hip fracture repair . DESIGN Pilot double-masked r and omized placebo-controlled trial . SETTING Large academic medical center . PARTICIPANTS Sixteen individuals aged 70 and older with hip fracture . INTERVENTION Donepezil 5 mg or placebo was r and omly allocated and initiated within 24 hours of surgery , preoperatively or postoperatively . Daily treatment was continued for 30 days or until side effects or the clinical situation required termination . MEASUREMENTS All outcomes were ascertained masked to treatment status . Information on drug tolerability and safety was obtained from the participant , nurse , and medical record . Delirium presence and severity were measured during daily hospital interviews and at 2 , 4 , and 6 weeks after surgery after a st and ardized assessment using the Confusion Assessment Method ( CAM ) and the Memorial Delirium Assessment Scale ( MDAS ) . RESULTS Participants in the donepezil and placebo arms had similar baseline characteristics . Participants in the donepezil arm experienced significantly more side effects . In longitudinal models , there were no significant differences between the donepezil and placebo arms with regard to delirium presence over time ( odds ratio = 0.9 , 95 % confidence interval ( CI ) = 0.4 - 2.3 ) or delirium severity over time ( effect size = -0.2 on 30-point MDAS scale , 95%CI = -1.5 - 1.2 ) . CONCLUSION Participants r and omized to donepezil had no significant improvement in delirium presence or severity but experienced more side effects . Overall , sufficient evidence was not found from this pilot study to warrant a definitive Phase III trial Background Hip fractures are common among frail elderly persons and often have serious consequences on function , mobility and mortality . Traditional treatment of these patients is performed in orthopedic departments without additional geriatric assessment . However , studies have shown that interdisciplinary geriatric treatment may be beneficial compared to traditional treatment . The aim of the present study is to investigate whether treatment of these patients in a Department of Geriatrics ( DG ) during the entire hospital stay gives additional benefits as compared to conventional treatment in a Department of Orthopaedic Surgery ( DOS ) . Findings A new clinical pathway for in-hospital treatment of hip fracture patients was developed . In this pathway patients were treated pre- and postoperatively in DG . Comprehensive geriatric assessment was performed as an interdisciplinary , multidimensional , systematic assessment of all patients focusing on each patient ’s capabilities and limitations as recommended in guidelines and systematic review s. Identification and treatment of co-morbidities , pain relief , hydration , oxygenation , nutrition , elimination , prevention and management of delirium , assessment of falls and osteoporosis were emphasized . Discharge planning started as early as possible . Initiation of rehabilitation with focus on early mobilisation and development of individual plans was initiated in hospital and continued after discharge from hospital . Fracture specific treatment was based upon st and ard treatment for the hospital , expert opinions and a review of the literature . Conclusion A new treatment program for old hip fracture patients was developed , introduced and run in the DG , the potential benefits of which being compared with traditional care of hip fracture patients in the DOS in a r and omised clinical trial Background and objectives : Postoperative confusion and delirium is a common complication in the elderly with a poorly understood pathophysiology . The aim of this study was to examine whether the type of anaesthesia ( general or regional ) plays a role in the development of cognitive impairment in elderly patients during the immediate postoperative period . Methods : Forty‐seven patients > 60 yr of age and undergoing major surgery were r and omly allocated to receive either regional or general anaesthesia . The mental status of the patients was assessed preoperatively and during the first three postoperative days with the Mini Mental State Examination . The incidence of delirium was also examined during the same period with the use of DSM III criteria . Results : Overall , during the first three postoperative days , the mean Mini Mental State Examination score decreased significantly ( P < 0.001 ) . However , this decline was very significant only in patients assigned to receive general anaesthesia ( P < 0.001 ) compared to regional anaesthesia . Nine patients developed delirium but the type of anaesthesia did not affect its incidence . The only important factor for the development of delirium was pre‐existing cardiovascular disease irrespective of anaesthesia type ( P < 0.025 ) . Conclusions : Elderly patients subjected to general anaesthesia displayed more frequent cognitive impairment during the immediate postoperative period in comparison to those who received a regional technique OBJECTIVE To determine whether limiting intraoperative sedation depth during spinal anesthesia for hip fracture repair in elderly patients can decrease the prevalence of postoperative delirium . PATIENTS AND METHODS We performed a double-blind , r and omized controlled trial at an academic medical center of elderly patients ( > or=65 years ) without preoperative delirium or severe dementia who underwent hip fracture repair under spinal anesthesia with propofol sedation . Sedation depth was titrated using processed electroencephalography with the bispectral index ( BIS ) , and patients were r and omized to receive either deep ( BIS , approximately 50 ) or light ( BIS , > or=80 ) sedation . Postoperative delirium was assessed as defined by Diagnostic and Statistical Manual of Mental Disorders ( Third Edition Revised ) criteria using the Confusion Assessment Method beginning at any time from the second day after surgery . RESULTS From April 2 , 2005 , through October 30 , 2008 , a total of 114 patients were r and omized . The prevalence of postoperative delirium was significantly lower in the light sedation group ( 11/57 [ 19 % ] vs 23/57 [ 40 % ] in the deep sedation group ; P=.02 ) , indicating that 1 incident of delirium will be prevented for every 4.7 patients treated with light sedation . The mean + /- SD number of days of delirium during hospitalization was lower in the light sedation group than in the deep sedation group ( 0.5+/-1.5 days vs 1.4+/-4.0 days ; P=.01 ) . CONCLUSION The use of light propofol sedation decreased the prevalence of postoperative delirium by 50 % compared with deep sedation . Limiting depth of sedation during spinal anesthesia is a simple , safe , and cost-effective intervention for preventing postoperative delirium in elderly patients that could be widely and readily adopted Introduction We hypothesized that delirium symptoms may respond differently to antipsychotic therapy . The purpose of this paper was to retrospectively compare duration and time to first resolution of individual delirium symptoms from the data base of a r and omized , double-blind , placebo-controlled study comparing quetiapine ( Q ) or placebo ( P ) , both with haloperidol rescue , for critically ill patients with delirium . Methods Data for 10 delirium symptoms from the eight-domain , intensive care delirium screening checklist ( ICDSC ) previously collected every 12 hours were extracted for 29 study patients . Data between the Q and P groups were compared using a cut-off P- value of ≤0.10 for this exploratory study . Results Baseline ICDSC scores ( 5 ( 4 to 7 ) ( Q ) vs 5 ( 4 to 6 ) ) ( median , interquartile range ( IQR ) ) and % of patients with each ICDSC symptom were similar in the two groups ( all P > 0.10 ) . Among patients with the delirium symptom at baseline , use of Q may lead to a shorter time ( days ) to first resolution of symptom fluctuation ( 4 ( Q ) vs. 14 , P = 0.004 ) , inattention ( 3 vs. 8 , P = .10 ) and disorientation ( 2 vs. 10 , P = 0.10 ) but a longer time to first resolution of agitation ( 3 vs. 1 , P = 0.04 ) and hyperactivity ( 5 vs. 1 , P = 0.07 ) . Among all patients , Q-treated patients tended to spend a smaller percent of time with inattention ( 47 ( 0 to 67 ) vs. 78 ( 43 to 100 ) , P = 0.025 ) , hallucinations ( 0 ( 0 to 17 ) vs. 28 ( 0 to 43 ) , P = 0.10 ) and symptom fluctuation ( 47 ( 19 to 67 ) vs. 89 ( 33 to 00 ) , P = 0.04 ] and there was a trend for Q-treated patients to spend a greater percent of time at an appropriate level of consciousness ( 26 % ( 13 to 63 % ) vs. 14 % ( 0 to 33 % ) , P = 0.17 ] . Conclusions Our exploratory analysis suggests that quetiapine may resolve several intensive care unit ( ICU ) delirium symptoms faster than the placebo . Individual symptom resolution appears to differ in association with the pharmacologic intervention ( that is , P vs Q , both with as needed haloperidol ) . Future studies evaluating antipsychotics in ICU patients with delirium should measure duration and resolution of individual delirium symptoms and their relation to long-term outcomes BACKGROUND People with cognitive impairment and dementia have a poor outcome after a hip fracture surgery , about 30 - 50 % of all those who sustain a hip fracture have dementia . Therefore the aim was to investigate whether a multidisciplinary postoperative intervention program could reduce postoperative complications and improve functional recovery among people with dementia . METHODS A r and omized controlled trial with subgroup analyses among patients with dementia . Sixty-four patients with femoral neck fracture , aged ≥70 years at Umeå University Hospital , Sweden . The intervention consisted of staff education , individualized care planning and rehabilitation , active prevention , detection and treatment of postoperative complications , especially delirium . The staff worked in teams to apply comprehensive geriatric assessment , management and rehabilitation , including a follow-up at 4 months postoperatively . The control group followed conventional postoperative routines . RESULTS There were fewer postoperative complications in the intervention group such as urinary tract infections , p=0.001 ; nutritional problems , p=0.025 ; postoperative delirium , p=0.002 ; falls , p=0.006 . At 4 months a larger proportion in the intervention group had regained their previous independent indoor walking ability performance , p=0.005 . At 12 months a larger proportion in the intervention group had regained the activities of daily living ( ADL ) performance level they had before the fracture , p=0.027 . CONCLUSION This study demonstrates that patients with dementia who suffer a hip fracture can benefit from multidisciplinary geriatric assessment and rehabilitation and should not be excluded from rehabilitation programs Background Approximately 40 % of hospitalized older adults have cognitive impairment ( CI ) and are more prone to hospital-acquired complications . The Institute of Medicine suggests using health information technology to improve the overall safety and quality of the health care system . Objective Evaluate the efficacy of a clinical decision support system ( CDSS ) to improve the quality of care for hospitalized older adults with CI . Design A r and
Output:
| Meta- analysis supported dexmedetomidine sedation , multicomponent interventions and antipsychotics were useful in preventing postoperative delirium |
MS211805 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Abstract Objective : To evaluate the effectiveness of combinations of three methods to promote physical activity . Design : R and omised controlled trial . Baseline assessment with post-intervention follow up at 12 weeks and 1 year . Setting : One urban general practice , 1995 - 7 . Participants : 523 adults aged 40 to 64 years , r and omised to four intervention groups and a control group . Interventions : Brief ( one interview ) or intensive ( six interviews over 12 weeks ) motivational interviewing based on the stages of change model of behaviour change , with or without financial incentive ( 30 vouchers entitling free access to leisure facilities ) . Main outcome measures : Physical activity score ; sessions of moderate and vigorous activity in the preceding four weeks . Results : Response rate was 81 % at 12 weeks and 85 % at one year . More participants in the intervention group reported increased physical activity scores at 12 weeks than controls ( 38 % v 16 % , difference 22 % , 95 % confidence interval for difference 13 % to 32 % ) , with a 55 % increase observed in those offered six interviews plus vouchers . Vigorous activity increased in 29 % of intervention participants and 11 % of controls ( difference 18 % , 10 % to 26 % ) , but differences between the intervention groups were not significant . Short term increases in activity were not sustained , regardless of intensity of intervention . Conclusions : The most effective intervention for promoting adoption of exercise was the most intensive . Even this did not promote long term adherence to exercise . Brief interventions promoting physical activity that are used by many schemes in the United Kingdom are of question able effectiveness . Key messages Schemes promoting physical activity are currently popular in general practice in Britain , but few have been rigorously evaluated and their effectiveness is unknown . In this study , the most effective intervention for promoting adoption of physical activity was the most intensive , involving six motivational interviews and a financial incentive A comparatively brief intervention ( one interview ) was only effective in the short term in around a third of participants Short term increases in physical activity were not maintained at one year follow up and even the most intensive intervention was ineffective in promoting long term adherence to increased physical activity . National and local government , health authorities , and primary healthcare teams should be cautious about current and future expenditure on , and implementation of , exercise prescription or referral BACKGROUND Using peer volunteers as delivery agents may improve translation of evidence -based physical activity promotion programs for older adults . This study examined whether tailored support from older peer volunteers could improve initiation and long-term maintenance of physical activity behavior . METHODS Participants were r and omized to 2 16-week , group-based programs : ( 1 ) peer-delivered , theory-based support for physical activity behavior change ; or ( 2 ) an intervention typically available in community setting s ( basic education , gym membership , and pedometer for self-monitoring ) , attention-matched with health education . Moderate-to-vigorous physical activity ( MVPA ) was assessed via daily self-report logs at baseline , at the end of the intervention ( 16 weeks ) , and at follow-up ( 18 months ) , with accelerometry validation ( RT3 ) in a r and om sub sample . RESULTS Seven peer volunteers and 81 sedentary adults were recruited . Retention at the end of the trial was 85 % and follow-up at 18 months was 61 % . Using intent-to-treat analyses , at 16 weeks , both groups had similar significant improvements in MVPA . At 18 months , the group supplemented with peer support had significantly more MVPA . CONCLUSIONS Trained peer volunteers may enhance long-term maintenance of physical activity gains from a community-based intervention . This approach has great potential to be adapted and delivered inexpensively in community setting Purpose . This study examined the broader use of a print-media intervention , which was previously shown to be effective at promoting physical activity to participants recruited from a regional Australian community , as a strategy suitable for a more diverse statewide population sample . Methods . Participants were r and omly selected adults who responded to a telephone interview conducted by the New South Wales Health Department and consented to participate in a r and omized controlled trial . Consenters were allocated to either intervention ( n = 361 ) or control ( n = 358 ) conditions . The intervention , a personalized letter plus stage-targeted booklets , was sent 1 week postbaseline . Data were collected via telephone interview at baseline and 2 and 8 months and were analyzed using repeated measures analysis of variance ( ANOVA ) and χ2 statistics . Results . The groups were similar at baseline ( mean age 43 ± 3 years ; 64 % women ) . Process evaluation showed high intervention recall ( 76 % at 2 months ) and high follow-up response rates ( > 85 % at 8 months ) were achieved . Nonsignificant increases in physical activity were observed ( F 1,719 = 2.18 , p = .14 ) . Discussion . A single mailing of stage-targeted print material s was not effective in promoting increases in physical activity among participants selected from the statewide population . Future research could examine how the effectiveness of print media might be enhanced , possibly by using supplementary media , community-based prompts , or other incentives Background Research ers theorize that interventions increase physical activity by influencing key theory-based mediators ( e.g. , behavioral processes ) . However , few studies have been adequately powered to examine the importance of mediators . Purpose This study examined both physical activity behavior and psychosocial mediators in a r and omized trial specifically powered to detect mediation . Methods Healthy , sedentary adults ( n = 448 ; 70 % Caucasian , 87 % women , mean age was 43 ) were r and omly assigned to either a 6-month print-based theory tailored physical activity intervention ( n = 224 ) or a 6-month health/wellness contact control arm ( n = 224 ) . Results The print intervention arm exhibited greater increases in physical activity than the control arm at 6 and 12 months ( p < .05 ) . Additionally , behavioral processes were found to be an important mediator of physical activity behavior . Conclusions It is important for research ers and practitioners to focus on increasing behavioral strategies for physical activity adoption . Future studies should examine other potential mediators of physical activity This study examined predictors of exercise maintenance following completion of a physical activity intervention . Sedentary adults recruited through newspaper advertisements were r and omly assigned to receive either ( a ) a motivation-matched intervention with feedback reports that were individually tailored ( IT ) to psychological variables from social cognitive theory and the Transtheoretical Model via computer expert system , or ( b ) a st and ard , print-based intervention ( ST ) . The intervention phase of the study included mailed assessment s and intervention material s at baseline , 1 , 3 , and 6 months . An assessment -only follow-up was conducted 6 months after the end of the intervention ( Month 12 ) . Participants were assessed for current physical activity participation , motivational readiness for physical activity , a number of psychological constructs posited to influence participation in physical activity ( e.g. , self-efficacy ) , and current affect . Significantly more participants in the IT condition met or exceeded exercise participation goals at the end of the intervention period and maintained , this level of physical activity through the Month 12 follow-up compared to ST participants . Prospect i ve analyses revealed significant differences in several psychological constructs both at program entry ( baseline ) and the end of the intervention period between individuals who maintained their physical activity participation through Month 12 and those who did not . Results suggest that the maintenance of physical activity following the end of an active intervention program , may be influenced by attitudes and behaviors acquired along with increased participation in physical activity , as well as by preexisting characteristics that individuals bring into treatment BACKGROUND The impact of a 6-month lifestyle change intervention on cardiovascular risk factors in obese , sedentary , postmenopausal women was examined . A secondary aim of this investigation was to determine whether the addition of self-control skills training to an empirically supported lifestyle change intervention would result in greater cardiovascular risk reduction . METHODS Forty-four women were r and omly assigned to receive either a lifestyle change or a lifestyle change with self-control skills intervention . Pretreatment and posttreatment weight loss , body composition , physical activity , cardiorespiratory fitness , diet , blood pressure ( BP ) , blood lipids , and psychosocial functioning were assessed . Also , at 1-year posttreatment , weight loss , body composition , self-reported physical activity , and psychosocial functioning were assessed . RESULTS The women significantly increased their physical activity ( + 39.6 % ) and cardiorespiratory fitness ( + 13.5 % ) and reduced their body weight ( -6.5 % ) , fat mass ( -7.4 % ) , body fat ( -2.4 % ) , BP ( SBP -6.2 % , DBP -9.2 % ) , total cholesterol ( -7.4 % ) , triglycerides ( -16.5 % ) , and low-density lipoprotein ( LDL ) cholesterol ( 9.1 % ) and improved their diet ( p < 0.05 ) . At the 1-year follow-up , women had regained approximately 63 % of their posttreatment weight loss ( p < 0.05 ) , but had maintained their previous increases in physical activity . Additionally , there were no significant changes in fat free mass , body fat , anxiety , or depression between the end of treatment and 1-year posttreatment . The addition of self-control skills training did not significantly improve cardiovascular risk reduction . CONCLUSIONS Lifestyle change interventions may be an effective means for reducing cardiovascular risk in obese , sedentary , postmenopausal women . However , greater attention should be devoted to the maintenance of these positive lifestyle changes Study objective : To determine if a self help intervention , delivered via written interactive material s ( the “ Walk in to Work Out ” pack ) , could increase active commuting behaviour ( walking and cycling ) . Design : R and omised controlled trial . The intervention group received the “ Walk in to Work Out ” pack , which contained written interactive material s based on the transtheoretical model of behaviour change , local information about distances and routes , and safety information . The control group received the pack six months later . Focus groups were also conducted after six months . Setting : Three workplaces in the city of Glasgow , Scotl and , UK . Participants : 295 employees who had been identified as thinking about , or doing some irregular , walking or cycling to work . Main results : The intervention group was almost twice as likely to increase walking to work as the control group at six months ( odds ratio of 1.93 , 95 % confidence intervals 1.06 to 3.52 ) . The intervention was not successful at increasing cycling . There were no distance travelled to work , gender , or age influences on the results . Twenty five per cent ( 95 % confidence intervals 17 % to 32 % ) of the intervention group , who received the pack at baseline , were regularly actively commuting at the 12 month follow up . Conclusion : The “ Walk in to Work Out ” pack was successful in increasing walking but not cycling . The environment for cycling must be improved before cycling will become a popular option Background The purpose of the study was to evaluate a 6-month intervention to promote office-employees ’ walking with pedometers and e-mail messages . Methods Participants were recruited by 10 occupational health care units ( OHC ) from 20 worksites with 2,230 employees . Voluntary and insufficiently physically active employees ( N = 241 ) were r and omized to a pedometer ( STEP , N = 123 ) and a comparison group ( COMP , N = 118 ) . STEP included one group meeting , log-monitored pedometer-use and six e-mail messages from OHC . COMP participated in data collection . Reach , effectiveness , adoption , implementation , maintenance ( RE- AIM ) and costs were assessed with question naires ( 0 , 2 , 6 , 12 months ) , process evaluation and interviews ( 12 months ) . Results The intervention reached 29 % ( N = 646 ) of employees in terms of participation willingness . Logistic regression showed that the proportion of walkers tended to increase more in STEP than in COMP at 2 months in “ walking for transportation ” ( Odds ratio 2.12 , 95%CI 0.94 to 4.81 ) and at 6 months in “ walking for leisure ” ( 1.86 , 95%CI 0.94 to 3.69 ) . Linear model revealed a modest increase in the mean duration of “ walking stairs ” at 2 and 6 months ( Geometric mean ratio 1.26 , 95%CI 0.98 to 1.61 ; 1.27 , 0.98 to 1.64 ) . Adoption and implementation succeeded as intended . At 12 months , some traces of the intervention were sustained in 15 worksites , and a slightly higher number of walkers in STEP in comparison with COMP was observed in “ walking stairs ” ( OR 2.24 , 95%CI 0.94 to 5.31 ) and in “ walking for leisure ” ( 2.07 , 95%CI 0.99 to 4.34 ) . The direct costs of the intervention were 43 Euros per participant . Conclusions The findings indicate only modest impact on some indicators of walking . Future studies should invest in reaching the employees , minimizing attrition rate and using objective walking assessment .Trial registerationIS RCT Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more The aim of the project was to reach inactive people through primary care offices and motivate them to become more active for health purpose s. Physical activity question naires based on the transtheoretical model ( TM ) of
Output:
| Good evidence was found for behavior change maintenance effects in healthy inactive adults , and underlying BCTs .
This review provides translational evidence to improve research , intervention design , and service delivery in physical activity interventions , while highlighting the lack of fidelity measurement |
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Input: BACKGROUND Falling is a common and morbid condition among elderly persons . Effective strategies to prevent falls have been identified but are underutilized . METHODS Using a nonr and omized design , we compared rates of injuries from falls in a region of Connecticut where clinicians had been exposed to interventions to change clinical practice ( intervention region ) and in a region where clinicians had not been exposed to such interventions ( usual-care region ) . The interventions encouraged primary care clinicians and staff members involved in home care , outpatient rehabilitation , and senior centers to adopt effective risk assessment s and strategies for the prevention of falls ( e.g. , medication reduction and balance and gait training ) . The outcomes were rates of serious fall-related injuries ( hip and other fractures , head injuries , and joint dislocations ) and fall-related use of medical services per 1000 person-years among persons who were 70 years of age or older . The interventions occurred from 2001 to 2004 , and the evaluations took place from 2004 to 2006 . RESULTS Before the interventions , the adjusted rates of serious fall-related injuries ( per 1000 person-years ) were 31.2 in the usual-care region and 31.9 in the intervention region . During the evaluation period , the adjusted rates were 31.4 and 28.6 , respectively ( adjusted rate ratio , 0.91 ; 95 % Bayesian credibility interval , 0.88 to 0.94 ) . Between the preintervention period and the evaluation period , the rate of fall-related use of medical services increased from 68.1 to 83.3 per 1000 person-years in the usual-care region and from 70.7 to 74.2 in the intervention region ( adjusted rate ratio , 0.89 ; 95 % credibility interval , 0.86 to 0.92 ) . The percentages of clinicians who received intervention visits ranged from 62 % ( 131 of 212 primary care offices ) to 100 % ( 26 of 26 home care agencies ) . CONCLUSIONS Dissemination of evidence about fall prevention , coupled with interventions to change clinical practice , may reduce fall-related injuries in elderly persons The aim of this evaluation study was to assess the impact of peer-presented education sessions on the falls-related attitude , knowledge and behaviour of older people . The evaluation was undertaken on the Bellarine Peninsula in Victoria , Australia , and adopted a non-r and omised pre-test post-test design . Baseline , 3 and 12 months follow-up data were collected for 107 individuals who attended the education sessions and 116 controls , matched by age range and sex . The groups were not strictly equivalent at baseline , with the intervention group having a greater knowledge about falls and falls prevention . Analyses which controlled for baseline differences showed that those who attended the education sessions maintained a greater knowledge of factors that can prevent falls at 12 months follow-up . The intervention group also made more changes in and around their home to prevent falls by 3 and 12 months follow-up . Younger participants who reported a previous history of falls and having taken action to prevent falls were most likely to take additional action . The results can help target this type of education program and suggest that their major benefit may lie in providing those who voluntarily attend with the impetus to take the most effective preventative action OBJECTIVES To determine whether a practice -based intervention can improve care for falls , urinary incontinence , and cognitive impairment . DESIGN Controlled trial . SETTING Two community medical groups . PARTICIPANTS Community-dwelling patients ( 357 at intervention sites and 287 at control sites ) aged 75 and older identified as having difficulty with falls , incontinence , or cognitive impairment . INTERVENTION Intervention and control practice s received condition case-finding , but only intervention practice s received a multicomponent practice -change intervention . MEASUREMENTS Percentage of quality indicators satisfied measured using a 13-month medical record abstract ion . RESULTS Before the intervention , the quality of care was the same in intervention and control groups . Screening tripled the number of patients identified as needing care for falls , incontinence , or cognitive impairment . During the intervention , overall care for the three conditions was better in the intervention than the control group ( 41 % , 95 % confidence interval (CI)=35 - 46 % vs 25 % , 95 % CI=20 - 30 % , P<.001 ) . Intervention group patients received better care for falls ( 44 % vs 23 % , P<.001 ) and incontinence ( 37 % vs 22 % , P<.001 ) but not for cognitive impairment ( 44 % vs 41 % , P=.67 ) than control group patients . The intervention was more effective for conditions identified by screening than for conditions identified through usual care . CONCLUSION A practice -based intervention integrated into usual clinical care can improve primary care for falls and urinary incontinence , although even with the intervention , less than half of the recommended care for these conditions was provided . More-intensive interventions , such as embedding intervention components into an electronic medical record , will be needed to adequately improve care for falls and incontinence BACKGROUND Since falling is associated with serious morbidity among elderly people , we investigated whether the risk of falling could be reduced by modifying known risk factors . METHODS We studied 301 men and women living in the community who were at least 70 years of age and who had at least one of the following risk factors for falling : postural hypotension ; use of sedatives ; use of at least four prescription medications ; and impairment in arm or leg strength or range of motion , balance , ability to move safely from bed to chair or to the bathtub or toilet ( transfer skills ) , or gait . These subjects were given either a combination of adjustment in their medications , behavioral instructions , and exercise programs aim ed at modifying their risk factors ( intervention group , 153 subjects ) or usual health care plus social visits ( control group , 148 subjects ) . RESULTS During one year of follow-up , 35 percent of the intervention group fell , as compared with 47 percent of the control group ( P = 0.04 ) . The adjusted incidence-rate ratio for falling in the intervention group as compared with the control group was 0.69 ( 95 percent confidence interval , 0.52 to 0.90 ) . Among the subjects who had a particular risk factor at base line , a smaller percentage of those in the intervention group than of those in the control group still had the risk factor at the time of re assessment , as follows : at least four prescription medications , 63 percent versus 86 percent , P = 0.009 ; balance impairment , 21 percent versus 46 percent , P = 0.001 ; impairment in toilet-transfer skills , 49 percent versus 65 percent , P = 0.05 ; and gait impairment , 45 percent versus 62 percent , P = 0.07 . CONCLUSIONS The multiple-risk-factor intervention strategy result ed in a significant reduction in the risk of falling among elderly persons in the community . In addition , the proportion of persons who had the targeted risk factors for falling was reduced in the intervention group , as compared with the control group . Thus , risk-factor modification may partially explain the reduction in the risk of falling BACKGROUND AND PURPOSE An abundance of evidence suggests that interventions targeting fall risk factors are effective ; however , it remains unknown whether , or to what extent , this body of evidence has affected the clinical practice of physical therapy providers . The purpose s of this study were : ( 1 ) to describe knowledge of , and attitudes toward , fall risk factors and fall reduction strategies ; ( 2 ) to assess self-reported use of fall reduction strategies with patients ; and ( 3 ) to identify factors associated with increased use of fall reduction strategies with patients among physical therapy providers exposed to a behavioral change strategy . SUBJECTS AND METHODS A cross-sectional survey of physical therapy providers from hospital-based and freest and ing outpatient physical therapy facilities throughout north- central Connecticut was conducted between October 2002 and April 2003 . The participants were 94 physical therapy providers who had been exposed to the Connecticut Collaboration for Fall Prevention ( CCFP ) behavioral change effort . The CCFP program uses multicomponent professional behavioral change strategies to embed fall risk factor assessment and management , based on evidence from r and omized controlled trials , into the clinical care of older patients . A telephone question naire -- focusing on fall risk factor knowledge and attitudes and self-reported fall risk factor assessment and management practice s before and after exposure to the CCFP efforts -- was administered to consenting physical therapy providers . RESULTS Environmental hazards and gait and balance deficits were named as fall risk factors by 86 ( 91 % ) and 73 ( 78 % ) participants , respectively . All of the targeted risk factors were mentioned by at least 30 % of the participants . Sixty-four participants ( 68 % ) reported increased fall reduction practice behaviors . The area of multiple medications was noted most frequently , with 77 participants ( 82 % ) noting new practice s related to medication use . Only knowledge of fall risk factors and pre-CCFP behaviors were associated with increased fall reduction practice s. DISCUSSION AND CONCLUSION Physical therapy providers reported an increase in practice behaviors in response to the multicomponent behavioral change strategy . Knowledge of fall risk factors was associated with increased fall reduction practice behaviors , most likely due to the focused nature of the education strategy
Output:
| The evidence around changing the way people who fall are managed within primary care practice s , and , layperson , peer or community delivered models was mixed .
IMPACT ON INDUSTRY Translating the evidence -base into practice involves changing the attitudes and behaviours of older people , healthcare professionals and organisations . |
MS211807 | ***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 The purpose of this study was to evaluate the efficacy and safety of acute quetiapine monotherapy in adolescents with schizophrenia . METHODS Patients ages 13 - 17 years with an American Psychiatric Association , Diagnostic and Statistical Manual of Mental Disorders , 4th ed . , Text Revision ( DSM-IV-TR ) diagnosis of schizophrenia and a Positive and Negative Syndrome Scale ( PANSS ) total score ≥60 were r and omized to 6 weeks of quetiapine ( 400 or 800 mg/day ) or placebo treatment . The primary efficacy measure was change in PANSS total score from baseline to day 42 . Safety endpoints included adverse events and assessment s of clinical chemistry values , suicidality , and extrapyramidal symptoms . RESULTS The intent-to-treat population included 220 patients . Least-squares mean change in PANSS total score from baseline to endpoint was -27.31 with quetiapine 400 mg/day , -28.44 with quetiapine 800 mg/day , and -19.15 with placebo ( p=0.043 and 0.009 for quetiapine 400 and 800 mg/day , respectively , vs. placebo ; mixed-model , repeated- measures analysis ) . Several secondary efficacy outcomes , including Clinical Global Impressions-Improvement score , supported the primary outcome measure in demonstrating significantly greater improvement in quetiapine groups than in the placebo group . Mean changes in body weight at day 42 were 2.2 kg and 1.8 kg for quetiapine 400 and 800 mg/day , respectively , and -0.4 kg for placebo . Mean changes in certain clinical chemistry parameters , including total cholesterol and triglycerides , were numerically greater in the quetiapine groups than in the placebo group . Adverse events associated with quetiapine were mostly mild to moderate in intensity and were consistent with its known profile in adults with schizophrenia . CONCLUSIONS In this 6-week study of adolescent patients , quetiapine at doses of 400 and 800 mg/day provided significant improvements in symptoms associated with schizophrenia in adolescent patients , including the primary efficacy measure of PANSS total score change . Quetiapine was generally well tolerated with a profile broadly similar to that reported in adult and adolescent population s. CLINICAL TRIAL REGISTRATION INFORMATION Quetiapine Fumarate ( SEROQUEL ( ™ ) ) Compared to Placebo in the Treatment of Adolescent Patients With Schizophrenia ( ANCHOR 112 ) . Available at : http://www . clinical trials.gov/ct2/show/NCT00090324?term=quetiapine+112&rank=1 OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate We examined the potential risks and benefits of switching from olanzapine to quetiapine in mentally stable , obese , or overweight patients with schizophrenia or schizoaffective disorder . Patients receiving olanzapine were r and omized to continuing olanzapine treatment ( N = 68 ; 7.5–20 mg/day ) or switching to quetiapine ( N = 65 ; 300–800 mg/day ) . Time to relapse was the primary study objective ; secondary objectives included changes in weight , metabolic parameters , and psychiatric symptoms , and discontinuation rates . No significant difference in time to relapse was observed ( p = 0.293 ) , but significantly more patients remained on treatment in the olanzapine group compared with the quetiapine group ( 70.6 % vs 43.1 % ; p = 0.002 ) . Olanzapine-treated patients had significantly lower rates of study discontinuation for lack of efficacy and psychiatric adverse events ( AEs ) compared to quetiapine ( 2.94 % vs 15.38 % , p = 0.015 ) . Significantly more patients in the olanzapine group experienced an increase in BMI ≥1 kg/m2 . Olanzapine-treated patients experienced significantly greater increases in weight from Weeks 2 through 13 . Switching patients with stable disease from olanzapine to quetiapine did not significantly shorten time to relapse , but produced more frequent study discontinuations due to lack of efficacy or psychiatric AEs with moderate but variable improvement in weight and no significant between-group differences in mean changes in metabolic laboratory parameters In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials OBJECTIVE Potency equivalents for anti-psychotic drugs are required to guide clinical dosing and for design ing and interpreting research studies . Available dosing guidelines are limited by the methods and data from which they were generated . METHOD With a two-step Delphi method , the authors surveyed a diverse group of international clinical and research experts , seeking consensus regarding antipsychotic dosing . The authors determined median clinical dosing equivalents and recommended starting , target range , and maximum doses for 61 drugs , adjusted for selected clinical circumstances . RESULTS Participants ( N=43 ) from 18 countries provided dosing recommendations regarding treatment of psychotic disorders for 37 oral agents and 14 short-acting and 10 long-acting parenteral agents . With olanzapine 20 mg/day as reference , estimated clinical equivalency ratios of oral agents ranged from 0.025 for sulpiride to 10.0 for trifluperidol . Seventeen patient and treatment characteristics , including age , hepatic and renal function , illness stage and severity , sex , and diagnosis , were associated with dosing modifications . CONCLUSIONS In the absence of adequate prospect i ve , r and omized drug-drug comparisons , the present findings provide broad , international , expert consensus-based recommendations for most clinical ly employed antipsychotic drugs . They can support clinical practice , trial design , and interpretation of comparative antipsychotic trials OBJECTIVE Placebo response and the rate of failed clinical trials are increasing in schizophrenia , resembling previous experience with antidepressant clinical trials . In depression , the percent of patients r and omized to placebo was shown to be strongly associated with drug-placebo differences ( signal detection).We hypothesized that this factor would also be important in recent schizophrenia clinical trials . To test this hypothesis a data base of acute schizophrenia placebo-controlled studies conducted between 1997 and 2008 was constructed . The data base contained 27 studies , with 79 active treatment arms . As percentage of patients r and omized to placebo increased , mean placebo improvement decreased ( p = 0.047 ) and mean drug-placebo differences tended to increase ( p = 0.166 ) . The frequency of significant contrasts from studies with ≥ 25 % r and omized to placebo was 83.3 % , compared with 58.3 % in studies with < 25 % r and omized to placebo . Caveats to these findings include limited data and confounding of potentially influential factors . These limitations prevent definitive conclusions . However , results are consistent with previous findings in depression where having a higher percent of patients r and omized to placebo increased drug-placebo differences OBJECTIVES This study aim ed to demonstrate efficacy of once-daily extended release quetiapine fumarate ( quetiapine XR ) versus placebo in patients with acute schizophrenia . METHODS In this 6-week , r and omized , double-blind study ( 5077IL/0041 ) patients were r and omized to receive quetiapine XR ( 300 , 600 , or 800 mg/day ) , quetiapine fumarate immediate release ( quetiapine IR ) [ 300 or 600 mg/day ] , or placebo . Primary endpoint was change from baseline in the Positive and Negative Syndrome Scale ( PANSS ) total score at Day 42 . Secondary variables included PANSS response rate at Day 42 ( > /=30 % decrease in PANSS total score from baseline ) and Clinical Global Impressions Severity ( CGI-S ) and Improvement ( CGI-I ) ratings . Safety assessment s included adverse event ( AE ) reporting and laboratory measures . RESULTS Of 532 patients r and omized , 222 ( 41.7 % ) completed the study . Improvements in PANSS total scores from baseline to Day 42 across treatment groups were : quetiapine XR 300 mg/day -5.01 , 600 mg/day -13.01 and 800 mg/day -11.17 , quetiapine IR 300 mg/day -9.42 and 600 mg/day -6.97 , and placebo -5.19 ; the difference in change was statistically significant only for quetiapine XR 600 mg/day ( p = 0.033 ) . There were no statistically significant differences between active treatment groups and placebo for PANSS response rates . Several post hoc analyses were conducted to explain the study efficacy outcome but these were inconclusive . Quetiapine XR was generally well tolerated with the majority of AEs being mild or moderate in intensity and no unexpected AEs . CONCLUSIONS Superior efficacy of quetiapine XR versus placebo in patients with schizophrenia was demonstrated for quetiapine XR 600 mg/day . The safety and tolerability profile of quetiapine XR was similar to that of quetiapine IR BACKGROUND Current antipsychotics have only a limited effect on 2 core aspects of schizophrenia : negative symptoms and cognitive deficits . Minocycline is a second-generation tetracycline that has a beneficial effect in various neurologic disorders . Recent findings in animal models and human case reports suggest its potential for the treatment of schizophrenia . These findings may be linked to the effect of minocycline on the glutamatergic system , through inhibition of nitric oxide synthase and blocking of nitric oxide-induced neurotoxicity . Other proposed mechanisms of action include effects of minocycline on the dopaminergic system and its inhibition of microglial activation . OBJECTIVE To examine the efficacy of minocycline as an add-on treatment for alleviating negative and cognitive symptoms in early-phase schizophrenia . METHOD A longitudinal double-blind , r and omized , placebo-controlled design was used , and patients were followed for 6 months from August 2003 to March 2007 . Seventy early-phase schizophrenia patients ( according to DSM-IV ) were recruited and 54 were r and omly allocated in a 2:1 ratio to minocycline 200 mg/d . All patients had been initiated on treatment with an atypical antipsychotic < or = 14 days prior to study entry ( risperidone , olanzapine , quetiapine , or clozapine ; 200 - 600 mg/d chlorpromazine
Output:
| Quetiapine IR caused sedation and increased rates of clinical ly significant weight gain , but no extrapyramidal effects were observed .
CONCLUSIONS Quetiapine IR has a small beneficial effect on overall psychotic symptoms over 2 - 12 weeks , but also leads to weight gain and sedation |
MS211808 | ***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: Goals of workThe purpose of this study is to compare the treatment and retention effects between st and ard decongestive lymphatic therapy ( DLT ) combined with pneumatic compression ( PC ) and modified DLT , in which the use of a short-stretch b and age is replaced with the use of Kinesio tape ( K-tape ) combined with PC . Material s and methods Forty-one patients with unilateral breast-cancer-related lymphedema for at least 3 months were r and omly grouped into the DLT group ( b and age group , N = 21 ) or the modified DLT group ( K-tape group , N = 20 ) . Skin care , 30-min manual lymphatic drainage , 1-h pneumatic compression therapy , application of a short-stretch b and age or K-tape for each group , and a 20-min physical therapy exercise were given during every treatment session . Patient evaluation items included physical therapy assessment , limb size , water composition of the upper extremity , lymphedema-related symptoms , quality of life , and patients ’ acceptance to the b and age or tape . Main results There was no significant difference between groups in all outcome variables ( P > 0.05 ) through the whole study period . Excess limb size ( circumference and water displacement ) and excess water composition were reduced significantly in the b and age group ; excess circumference and excess water composition were reduced significantly in the tape group . The acceptance of K-tape was better than the b and age , and benefits included longer wearing time , less difficulty in usage , and increased comfort and convenience ( P < 0.05 ) . Conclusions The study results suggest that K-tape could replace the b and age in DLT , and it could be an alternative choice for the breast-cancer-related lymphedema patient with poor short-stretch b and age compliance after 1-month intervention . If the intervention period was prolonged , we might get different conclusion . Moreover , these two treatment protocol s are inefficient and cost time in application . More efficient treatment protocol is needed for clinical practice BACKGROUND Lymphedema following breast cancer treatment is one of the most morbid conditions affecting breast cancer survivors . Currently , no therapy completely cures this condition . Comprehensive Decongestive Therapy ( CDT ) , a novel physiotherapeutic method offers promising results in managing this condition . This therapy is being widely used in the West . Till date , there are no studies evaluating the effectiveness and feasibility of this therapy in the east . MATERIAL S AND METHODS The therapeutic responses of 25 patients with postmastectomy lymphedema were analyzed prospect ively in this study . Each patient received an intensive phase of therapy for eight days from trained physiotherapists , which included manual lymphatic drainage , multi layered compression b and aging , exercises , and skin care . Instruction in self management techniques were given to the patients on completion of intensive therapy . The patients were followed up for three months . Changes in the volume of the edematous limb were assessed with a geometric approximation derived from serial circumference measurements of the limb and by water displacement volumetry . Changes in skin and sub cutis thickness were assessed using high frequency ultrasound . RESULTS The reduction in limb volume observed after therapy was 32.3 % and 42 % of the excess , by measurement and volumetry , respectively . The maximum reduction was obtained after the intensive phase . The reduction in skin and subcutis thickness of the edematous limb followed the same pattern as volume reduction . Patients could maintain the reduction obtained by strictly following the protocol s of the maintenance phase . CONCLUSIONS CDT combined with long-term self management is effective in treating post mastectomy lymphedema . The tropical climate is a major factor limiting the regular use of b and ages by the patients Background Women who develop secondary arm lymphoedema subsequent to treatment associated with breast cancer require life-long management for a range of symptoms including arm swelling , heaviness , tightness in the arm and sometimes the chest , upper body impairment and changes to a range of parameters relating to quality of life . While exercise under controlled conditions has had positive outcomes , the impact of yoga has not been investigated . The aim of this study is to determine the effectiveness of yoga in the physical and psycho-social domains , in the hope that women can be offered another safe , holistic modality to help control many , if not all , of the effects of secondary arm lymphoedema . Methods and design A r and omised controlled pilot trial will be conducted in Hobart and Launceston with a total of 40 women receiving either yoga intervention or current best practice care . Intervention will consist of eight weeks of a weekly teacher-led yoga class with a home-based daily yoga practice delivered by DVD . Primary outcome measures will be the effects of yoga on lymphoedema and its associated symptoms and quality of life . Secondary outcome measures will be range of motion of the arm and thoracic spine , shoulder strength , and weekly and daily physical activity . Primary and secondary outcomes will be measured at baseline , weeks four , eight and a four week follow up at week twelve . Range of motion of the spine , in a self-nominated group , will be measured at baseline , weeks eight and twelve . A further outcome will be the women ’s perceptions of the yoga collected by interview at week eight . Discussion The results of this trial will provide information on the safety and effectiveness of yoga for women with secondary arm lymphoedema from breast cancer treatment . It will also inform methodology for future , larger trials . Trial registration The incidence of breast cancer (BC)‐related lymphedema ( LE ) ranges from 7 % to 47 % . Successful management of LE relies on early diagnosis using sensitive measurement techniques . In the current study , the authors demonstrated the effectiveness of a surveillance program that included preoperative limb volume measurement and interval postoperative follow‐up to detect and treat sub clinical LE Objective : To compare the long-term efficacy of pneumatic compression and low-level laser therapies in the management of postmastectomy lymphoedema . Design : R and omized controlled trial . Setting : Department of Physical Medicine and Rehabilitation of Cukurova University , Turkey . Subjects : Forty-seven patients with postmastectomy lymphoedema were enrolled in the study . Interventions : Patients were r and omly allocated to pneumatic compression ( group I , n=24 ) and low-level laser ( group II , n=23 ) groups . Group I received 2 hours of compression therapy and group II received 20 minutes of laser therapy for four weeks . All patients were advised to perform daily limb exercises . Main measures : Demographic features , difference between sum of the circumferences of affected and unaffected limbs ( ▵ C ) , pain with visual analogue scale and grip strength were recorded . Results : Mean age of the patients was 48.3 ( 10.4 ) years . ▵ C decreased significantly at one , three and six months within both groups , and the decrease was still significant at month 12 only in group II ( P = 0.004 ) . Improvement of group II was greater than that of group I post treatment ( P = 0.04 ) and at month 12 after 12 months ( P = 0.02 ) . Pain was significantly reduced in group I only at posttreatment evaluation , whereas in group II it was significant post treatment and at follow-up visits . No significant difference was detected in pain scores between the two groups . Grip strength was improved in both groups , but the differences between groups were not significant . Conclusions : Patients in both groups improved after the interventions . Group II had better long-term results than group I. Low-level laser might be a useful modality in the treatment of postmastectomy lymphoedema We examined the effects of low stretch compression b and aging ( CB ) alone or in combination with manual lymph drainage ( MLD ) in 38 female patients with arm lymphedema after treatment for breast cancer . After CB therapy for 2 weeks ( Part I ) , the patients were allocated to either CB or CB + MLD for 1 week ( Part II ) . Arm volume and subjective assessment s of pain , heaviness and tension were measured . The mean lymphedema volume reduction for the total group during Part I was 188 ml ( p < 0.001 ) , a mean reduction of 26 % ( p < 0.001 ) . During Part II the volume reduction in the CB + MLD group was 47 ml ( p < 0.001 ) and in CB group 20 ml . These differences were not significant ( p = 0.07 ) . A percentage reduction of 11 % ( p < 0.001 ) in the CB + MLD group and 4 % in the CB group was significantly different ( p = 0.04 ) . In both the CB and the CB + MLD group , a decrease of feeling of heaviness ( p < 0.006 and p < 0.001 , respectively ) and tension ( p < 0.001 for both ) in the arm was found , but only the CB + MLD group showed decreased pain ( p < 0.03 ) . Low stretch compression b and aging is an effective treatment giving volume reduction of slight or moderate arm lymphedema in women treated for breast cancer . Manual lymph drainage adds a positive effect We compared manual lymph drainage ( MLD ) with sequential pneumatic compression ( SPC ) for treatment of unilateral arm lymphedema in 28 women previously treated for breast cancer . After 2 weeks of therapy with a st and ard compression sleeve ( Part I ) with maintenance of a steady arm volume , each patient was r and omly assigned to either one of two treatment regimens ( Part II ) . MLD was performed according to the Vodder technique for 45 min/day and SPC was performed with a pressure of 40 - 60 mmHg for 2 hours/day . Both treatments were carried out for 2 weeks . Arm volume was measured by water displacement . Arm mobility , strength , and subjective assessment s were also determined . Lymphedema was reduced by 49 ml ( 7 % reduction ) ( p = 0.01 ) in the total group during Part I. During Part II , the MLD group decreased by 75 ml ( 15 % reduction ) ( p < 0.001 ) and the SPC group by 28 ml ( 7 % reduction ) ( p = 0.03 ) . The total group reported a decrease of tension ( p = 0.004 ) and heaviness ( p = 0.01 ) during Part I. During Part II , only the MLD group reported a further decrease of tension ( p = 0.01 ) and heaviness ( p = 0.008 ) . MLD and SPC each significantly decreased arm volume but no significant difference was detected between the two treatment methods Lymphedema is a chronic and progressive long-term adverse effect of breast cancer treatment commonly defined by swelling of the affected arm . Current clinical guidelines indicate that women with and at risk for lymphedema should protect the affected arm from overuse . In clinical practice , this often translates into risk aversive guidance to avoid using the arm . This could lead to a disuse pattern that may increase the likelihood of injury from common activities of daily living . Further , such guidance poses an additional barrier to staying physically active , potentially translating to weight gain , which has been shown to be associated with worse clinical course for women with lymphedema . We hypothesize that a program of slowly progressive strength training with no upper limit on the amount of weight that may be lifted would gradually increase the physiologic capacity of the arm so that common activities represent a decreasing percentage of maximal capacity . Theoretically , this increased capacity should decrease the risk that daily activities put stress on the lymphatic system of the affected side . The Physical Activity and Lymphedema ( PAL ) Trial is a recently completed r and omized controlled exercise intervention trial that recruited 295 breast cancer survivors ( 141 with lymphedema at study entry , 154 at risk for lymphedema at study entry ) . The purpose of this report is to provide detail regarding the study design , statistical design , and protocol of the PAL trial Background Secondary arm lymphoedema continues to affect at least 20 % of women after treatment for breast cancer requiring lifelong professional treatment and self-management . The holistic practice of yoga may offer benefits as an adjunct self-management option . The aim of this small pilot trial was to gain preliminary data to determine the effect of yoga on women with stage one breast cancer-related lymphoedema ( BCRL ) . This paper reports the results for the primary and secondary outcomes . Methods Participants were r and omised , after baseline testing , to receive either an 8-week yoga intervention ( n = 15 ) , consisting of a weekly 90-minute teacher-led class and a 40-minute daily session delivered by DVD , or to a usual care wait-listed control group ( n = 13 ) . Primary outcome measures were : arm volume of lymphoedema measured by circumference and extra-cellular fluid measured by bioimpedance spectroscopy . Secondary outcome measures were : tissue in duration measured by tonometry ; levels of sensations , pain , fatigue , and their limiting effects all measured by a visual analogue scale ( VAS ) and quality of life based on the Lymphoedema Quality of Life Tool ( LYMQOL ) . Measurements were conducted at baseline , week 8 ( post-intervention ) and week 12 ( four weeks after cessation of the intervention ) . Results At week 8 , the intervention group had a greater decrease in tissue in duration of the affected upper arm compared to the control group ( p = 0.050 ) , as well as a greater reduction in the symptom sub-scale for QOL ( p = 0.038 ) . There was no difference in arm volume of lymphoedema or extra-cellular fluid between groups at week 8 ; however , at week 12 , arm volume increased more for the intervention group than the control group ( p = 0.032 ) . Conclusions An 8-week yoga intervention reduced tissue in duration of the affected upper arm and decreased the QOL sub-scale of symptoms . Arm volume of lymphoedema and extra-cellular fluid did not increase . These benefits did not last on cessation of the intervention when arm volume of
Output:
| Exercise seems beneficial in reducing oedema volume in BCRL .
IPC seems beneficial in helping to reduce the oedema volume in the acute phase of treatment .
Compression sleeves do not aid in the volume reduction in the acute phase ; however , they do prevent additional swelling |
MS211809 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Online therapy offers many advantages over face-to-face therapy . Interapy includes psychoeducation , screening , effect measures , and a protocol -driven treatment via the Internet for people suffering from posttraumatic stress . The present article reports the results of a controlled trial on the Internet-driven treatment of posttraumatic stress and grief in a group of people who manifested mild to relatively severe trauma symptoms . Participants in the treatment condition ( n=69 ) improved significantly more than participants in the waiting-list control condition ( n=32 ) on trauma-related symptoms and general psychopathology . The effect sizes were large . On most subscales , more than 50 % of the treated participants showed reliable change and clinical ly significant improvement , with the highest percentages being found for depression and avoidance Background Posttraumatic stress disorder ( PTSD ) develops in 10 - 20 % of injury patients . We developed a novel , self-guided Internet-based intervention ( called Trauma TIPS ) based on techniques from cognitive behavioral therapy ( CBT ) to prevent the onset of PTSD symptoms . Objective To determine whether Trauma TIPS is effective in preventing the onset of PTSD symptoms in injury patients . Methods Adult , level 1 trauma center patients were r and omly assigned to receive the fully automated Trauma TIPS Internet intervention ( n=151 ) or to receive no early intervention ( n=149 ) . Trauma TIPS consisted of psychoeducation , in vivo exposure , and stress management techniques . Both groups were free to use care as usual ( non protocol ized talks with hospital staff ) . PTSD symptom severity was assessed at 1 , 3 , 6 , and 12 months post injury with a clinical interview ( Clinician-Administered PTSD Scale ) by blinded trained interviewers and self-report instrument ( Impact of Event Scale — Revised ) . Secondary outcomes were acute anxiety and arousal ( assessed online ) , self-reported depressive and anxiety symptoms ( Hospital Anxiety and Depression Scale ) , and mental health care utilization . Intervention usage was documented . Results The mean number of intervention logins was 1.7 , SD 2.5 , median 1 , interquartile range ( IQR ) 1 - 2 . Thirty-four patients in the intervention group did not log in ( 22.5 % ) , 63 ( 41.7 % ) logged in once , and 54 ( 35.8 % ) logged in multiple times ( mean 3.6 , SD 3.5 , median 3 , IQR 2 - 4 ) . On clinician-assessed and self-reported PTSD symptoms , both the intervention and control group showed a significant decrease over time ( P<.001 ) without significant differences in trend . PTSD at 12 months was diagnosed in 4.7 % of controls and 4.4 % of intervention group patients . There were no group differences on anxiety or depressive symptoms over time . Post hoc analyses using latent growth mixture modeling showed a significant decrease in PTSD symptoms in a subgroup of patients with severe initial symptoms ( n=20 ) ( P<.001 ) . Conclusions Our results do not support the efficacy of the Trauma TIPS Internet-based early intervention in the prevention of PTSD symptoms for an unselected population of injury patients . Moreover , uptake was relatively low since one-fifth of individuals did not log in to the intervention . Future research should therefore focus on innovative strategies to increase intervention usage , for example , adding gameplay , embedding it in a blended care context , and targeting high-risk individuals who are more likely to benefit from the intervention . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 57754429 ; http://www.controlled-trials.com/IS RCT N57754429 ( Archived by WebCite at http://webcitation.org/6FeJtJJyD ) Background Suicide , attempted suicide and suicidal thoughts are major public health problems worldwide . Effective face-to-face treatments are Cognitive Behavioural Therapy ( CBT ) , Dialectical Behavioural Therapy ( DBT ) and Problem Solving Treatment ( PST ) . However , about two-thirds of persons who die by suicide have not been in contact with mental health care services in the preceding year , and many have never been treated . Furthermore , many patients do not disclose their suicidal thoughts to their care provider . This may be out of shame , due to fear of stigma or due to lack of trust in ( mental ) health care . Since many suicidal individuals seek information online , the internet provides an opportunity to reach suicidal individuals who would not be contacted otherwise . By providing a self-help intervention online , persons can anonymously learn to gain control over their suicidal thoughts . There is convincing evidence that self-help is effective for a number of mental disorders . In this study the effectiveness for suicidal thoughts is examined . Methods / Design In this study , a recently developed self-help intervention will be evaluated in a R and omized Controlled Trial . The intervention is based on Cognitive Behavioural Therapy and is aim ed at subjects who experience mild to moderate suicidal thoughts . This is defined as a score between 1 and 26 on the Beck Scale for Suicidal Ideation ( BSS ) . Higher and lower scores are excluded . In addition , severely depressed subjects are excluded . In total , 260 subjects will be r and omly allocated to the intervention-condition ( N = 130 ) or to the information-control condition ( N = 130 ) . Self-report question naires will be filled out at baseline , 6 weeks after baseline and 18 weeks after baseline . Primary outcome measure is the reduction in frequency and intensity of suicidal thoughts . Secondary outcome measures are the reduction of hopelessness , anxiety and depression , sleeplessness , worry and quality of life measures . Discussion This study is the first to evaluate the effectiveness of a web-based self-help intervention for suicidal thoughts . Several limitations and strengths of the design are discussed . Trial Registration Netherl and s Trial Register , OBJECTIVE The aim of this article was to evaluate the effectiveness of an information provision web-based early intervention via a r and omized controlled trial for children and their parents following pediatric unintentional injury . METHOD Participants were r and omly assigned to an intervention ( n = 29 ) or a control group ( n = 27 ) following baseline measurements . Further assessment was taken at 4 - 6 weeks and 6 months post-trauma event . RESULTS Analyses revealed that children within the intervention group reported improved anxiety , in comparison to a worsening of symptoms for children in the control group . Furthermore , children who had higher baseline trauma scores reported the intervention to be helpful . CONCLUSIONS The intervention showed promising results in its ability to aid child recovery OBJECTIVE The authors report an 8-week r and omized , controlled proof-of-concept trial of a new therapist-assisted , Internet-based , self-management cognitive behavior therapy versus Internet-based supportive counseling for posttraumatic stress disorder ( PTSD ) . METHOD Service members with PTSD from the attack on the Pentagon on September 11th or the Iraq War were r and omly assigned to self-management cognitive behavior therapy ( N=24 ) or supportive counseling ( N=21 ) . RESULTS The dropout rate was similar to regular cognitive behavior therapy ( 30 % ) and unrelated to treatment arm . In the intent-to-treat group , self-management cognitive behavior therapy led to sharper declines in daily log-on ratings of PTSD symptoms and global depression . In the completer group , self-management cognitive behavior therapy led to greater reductions in PTSD , depression , and anxiety scores at 6 months . One-third of those who completed self-management cognitive behavior therapy achieved high-end state functioning at 6 months . CONCLUSIONS Self-management cognitive behavior therapy may be a way of delivering effective treatment to large numbers with unmet needs and barriers to care This study compared the efficacy of an Internet-based , 8-week self-help program for traumatic event-related consequences ( SHTC ) ( n = 13 ) to a wait-list ( WL ) condition ( n = 14 ) . The SHTC consisted of cognitive-behavioral modules that progressed from the least anxiety-provoking component ( i.e. , information ) to the most anxiety-provoking ( i.e. , exposure ) . Participants were those who had experienced a traumatic event and had been experiencing sub clinical levels of symptoms associated with the event . Participants mastered the material in each module before proceeding to the next module . Pre- and post-treatment assessment s revealed that SHTC participants decreased avoidance behavior , frequency of intrusive symptoms , state anxiety , and depressive symptoms , and increased coping skills and coping self-efficacy significantly more than WL participants . SHTC participants demonstrated more clinical ly significant improvement than WL individuals Background Suicidal ideation is highly prevalent , but often remains untreated . The Internet can be used to provide accessible interventions . Objective To evaluate the cost-effectiveness of an online , unguided , self-help intervention for reducing suicidal ideation . Methods A total of 236 adults with mild to moderate suicidal thoughts , defined as scores between 1 - 26 on the Beck Scale for Suicide Ideation ( BSS ) , were recruited in the general population and r and omized to the intervention ( n = 116 ) or to a waitlist , information-only , control group ( n = 120 ) . The intervention aim ed to decrease the frequency and intensity of suicidal ideation and consisted of 6 modules based on cognitive behavioral techniques . Participants in both groups had unrestricted access to care as usual . Assessment s took place at baseline and 6 weeks later ( post-test ) . All question naires were self-report and administered via the Internet . Treatment response was defined as a clinical ly significant decrease in suicidal ideation on the BSS . Total per-participant costs encompassed costs of health service uptake , participants ’ out-of-pocket expenses , costs stemming from production losses , and intervention costs . These were expressed in Euros ( € ) for the reference year 2009 . Results At post-test , treatment response was 35.3 % and 20.8 % in the experimental and control conditions , respectively . The incremental effectiveness was 0.35 − 0.21 = 0.15 ( SE 0.06 , P = .01 ) . The annualized incremental costs were −€5039 per participant . Therefore , the mean incremental cost-effectiveness ratio ( ICER ) was estimated to be −€5039/0.15 = −€34,727 after rounding ( US −$41,325 ) for an additional treatment response , indicating annual cost savings per treatment responder . Conclusions This is the first trial to indicate that online self-help to reduce suicidal ideation is feasible , effective , and cost saving . Limitations included reliance on self-report and a short timeframe ( 6 weeks ) . Therefore , replication with a longer follow-up period is recommended
Output:
| The results showed that research into online psychological crisis intervention has been conducted in several different countries , especially the Netherl and s and Australia , and that the users of these tools benefit from them .
Online crisis interventions have been developed and research ed in many countries around the world . |
MS211810 | ***TASK*** the task is to summarize an input biomedical literature 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: Patients with first-episode schizophrenia appear to respond to lower doses of neuroleptics , and to be more sensitive to developing extrapyramidal side-effects . The authors therefore compared in such patients the efficacy and extrapyramidal tolerability of comparatively low dosages of the atypical neuroleptic risperidone and of the conventional neuroleptic haloperidol . Risperidone was hypothesized to have better extrapyramidal tolerability and efficacy in treating negative symptoms . Patients were r and omly assigned under double-blind conditions to receive risperidone ( n=143 ) or haloperidol ( n=146 ) for 8 wk . The primary efficacy criterion was the estimated difference in the mean change in the Positive and Negative Symptom Scale ( PANSS ) negative score between treatment groups ; secondary efficacy criteria were changes on the PANSS total score and other PANSS subscores , and several other measures of psychopathology and general functioning . The primary tolerability criterion was the difference in baseline-adjusted occurrence rates of extrapyramidal side-effects measured with the Simpson-Angus Scale ( SAS ) compared between treatment groups . The main hypothesis was that risperidone would be superior in terms of improving negative symptoms and lowering the risk of extrapyramidal symptoms . Secondary tolerability criteria were the other extrapyramidal symptoms , measured with the Hillside Akathisia Scale ( HAS ) and the Abnormal Involuntary Movement Scale ( AIMS ) . The average mean daily doses were 3.8 mg ( s.d.=1.5 ) for risperidone and 3.7 mg ( s.d.=1.5 ) for haloperidol . There were similar , significant improvements in both treatment groups in the primary and secondary efficacy criteria . At week 8 nearly all scores of extrapyramidal side-effects indicated a significantly higher prevalence of extrapyramidal side-effects with haloperidol than with risperidone [ SAS : risperidone 36.5 % of patients ; haloperidol 51.5 % of patients ; likelihood ratio test , chi2(1)=7.8 , p=0.005 ] . There were significantly fewer drop-outs [ risperidone n=55 , drop-out rate=38.5 % ; haloperidol n=79 , drop-out rate=54.1 % , chi2(1)=7.1 , p=0.009 ] and a longer non-discontinuation time [ risperidone : average of 50.8 d to drop-out ; haloperidol : average of 44.0 d to drop-out ; log rank test , chi2(1)=6.4 , p=0.011 ] in the risperidone group . Risperidone and haloperidol appear to be equally effective in treating negative and other symptoms of first-episode schizophrenia . Risperidone has better extrapyramidal tolerability and treatment retention rate than the equivalent dose of haloperidol in these patients OBJECTIVE Potency equivalents for anti-psychotic drugs are required to guide clinical dosing and for design ing and interpreting research studies . Available dosing guidelines are limited by the methods and data from which they were generated . METHOD With a two-step Delphi method , the authors surveyed a diverse group of international clinical and research experts , seeking consensus regarding antipsychotic dosing . The authors determined median clinical dosing equivalents and recommended starting , target range , and maximum doses for 61 drugs , adjusted for selected clinical circumstances . RESULTS Participants ( N=43 ) from 18 countries provided dosing recommendations regarding treatment of psychotic disorders for 37 oral agents and 14 short-acting and 10 long-acting parenteral agents . With olanzapine 20 mg/day as reference , estimated clinical equivalency ratios of oral agents ranged from 0.025 for sulpiride to 10.0 for trifluperidol . Seventeen patient and treatment characteristics , including age , hepatic and renal function , illness stage and severity , sex , and diagnosis , were associated with dosing modifications . CONCLUSIONS In the absence of adequate prospect i ve , r and omized drug-drug comparisons , the present findings provide broad , international , expert consensus-based recommendations for most clinical ly employed antipsychotic drugs . They can support clinical practice , trial design , and interpretation of comparative antipsychotic trials An international , multicenter , double-blind study was conducted in 183 patients with a first psychotic episode ( provisional schizophreniform disorder or schizophrenia ; DSM-III-R ) treated with flexible doses of risperidone or haloperidol for 6 weeks . At endpoint , 63 percent of risperidone-treated patients and 56 percent of haloperidol-treated patients were clinical ly improved ( > or = 50 % reduction in Positive and Negative Syndrome Scale total scores ) . Risperidone was better tolerated than haloperidol : the severity of extrapyramidal symptoms was significantly lower in the risperidone-treated patients ; significantly fewer risperidone-treated patients required antiparkinsonian medication ; and significantly fewer discontinued treatment because of adverse events . A post hoc analysis revealed that low doses of these antipsychotics were efficacious in some patients . Furthermore , the severity of extrapyramidal symptoms and the use of antiparkinsonian medications were significantly lower in patients receiving low doses ( maximum , < or = 6 mg/day ) than high doses ( maximum , > 6 mg/day ) of risperidone or haloperidol . These findings are consistent with the suggestion that patients with a first psychotic episode may require low doses of antipsychotic medications . Studies design ed specifically to compare low and high doses of antipsychotics are warranted to help optimize treatment for these patients OBJECTIVE This multicenter , double-blind , placebo-controlled study evaluated the efficacy and safety of three doses of sertindole ( 12 , 20 , and 24 mg/day ) and haloperidol ( 4 , 8 , and 16 mg/day ) in the treatment of psychotic symptoms for 497 hospitalized patients with schizophrenia . METHOD The patients were r and omly assigned to one of the medication groups and received treatment for 8 weeks . Changes in Positive and Negative Syndrome Scale , Scale for the Assessment of Negative Symptoms , Brief Psychiatric Rating Scale , and Clinical Global Impression scores were used as evaluations of treatment efficacy . Three rating scales were used to assess extrapyramidal symptoms as well as the occurrence of adverse events and the use of medications related to extrapyramidal symptoms . RESULTS Both sertindole and haloperidol were comparably effective in the treatment of psychosis , and all dose levels were significantly more effective than placebo . For the treatment of negative symptoms , only sertindole , 20 mg/day , was significantly more effective than placebo . For all extrapyramidal symptom measures , sertindole was clinical ly and statistically indistinguishable from placebo , and rates of extrapyramidal symptoms were not dose related . All dose levels of haloperidol produced significantly more extrapyramidal symptoms than placebo or sertindole . Adverse events associated with sertindole treatment were mild in severity . CONCLUSIONS Sertindole is a new antipsychotic agent effective for the treatment of both the positive and negative symptoms of schizophrenia , with motor side effects that are indistinguishable from those associated with placebo The mechanism of action of a relatively new antipsychotic drug-Risperidone differs from conventional antipsychotics like Haloperidol . We compared low dosages of Risperidone with near equivalent dosages of Haloperidol in first episode drug naive Acute and Transient Psychotic disorder . A single blind r and omised four-week study protocol was employed . Highly significant and comparable efficacy as assessed by Brief Psychiatric Rating Scale and Global Assessment of Functioning Scale was seen at the end of the Study protocol in both the groups . Risperidone had significantly , an early onset of action on some of the positive as well as negative symptoms with less incidence of Extrapyramidal Symptoms in comparison to Haloperidol . We conclude that Risperidone may represent a potential useful first line agent in the treatment of Acute and Transient Psychotic Disorder BACKGROUND Studies on the effects of antipsychotics on cognitive deficits in schizophrenia mostly suggest a superior effect of atypical over typical compounds , although findings are inconsistent and effect sizes small . Several method ological issues , such as heterogeneous patient sample s , incomparable drug doses , effects of prior medication , construct validity , and retest effects on neuropsychological tasks , confound most results and the comparability between studies . Consequently , the conclusion concerning effects of antipsychotics on cognition is still equivocal . OBJECTIVE The present r and omized clinical trial examined the effects on cognition of comparatively low doses of a typical antipsychotic ( zuclopenthixol ) and an atypical antipsychotic ( risperidone ) in a homogeneous group of drug-naive first-episode schizophrenic patients in a longitudinal setting . METHODS First-episode schizophrenic patients who had never previously been exposed to antipsychotic treatment ( N=25 ) were r and omly allocated to treatment with flexible doses of zuclopenthixol or risperidone in an open-label design . Cognitive functions were examined both when patients were drug-naive , and after 13 weeks of treatment . A comprehensive neuropsychological battery was used in order to optimize construct validity , and principal components of cognitive functions were extrapolated in order to reduce type I errors . A healthy control group was tested at baseline and after 13 weeks , in order to examine retest effects . The cognitive domains studied were executive functions , selective attention , and reaction time . RESULTS The patients showed considerable cognitive deficits when drug-naive . There were few differential effects of risperidone and zuclopenthixol on cognitive deficits , except for a differential significance , respectively , tendency towards improved reaction and movement times in the risperidone group , and a lack of such in the zuclopenthixol group . These differences were no longer significant after covarying for extrapyramidal side effects and anticholinergic medication that were more prevalent in the zuclopenthixol group and the increases after medication were comparable with retest effects in controls . CONCLUSION The study underscores the importance of examining impact of factors , such as clinical improvement , extrapyramidal side effects , anticholinergic medication and retest effects in longitudinal efficacy studies . This study does not support efficacy of either risperidone or zuclopenthixol on cognitive functions in drug-naive schizophrenia patients after 3 months of medication , because neither could be distinguished from retest effects of the healthy control group OBJECTIVE R and omized controlled drug trials have demonstrated that antipsychotic medication is effective to rapidly improve psychotic symptomatology in first-episode psychosis . However , these results may not be generalizable to routine clinical practice . We evaluated the effectiveness , tolerability , and safety of olanza-pine , risperidone , and haloperidol in individuals with first-episode nonaffective psychosis who are representative of clinical practice and who are treated in routine clinical setting s. METHOD 172 patients participated in a practical clinical trial and were r and omly assigned to haloperidol ( N = 56 ) , risperidone ( N = 61 ) , and olanzapine ( N = 55 ) . The mean modal daily doses were 5.4 mg/day for halo-peridol , 4 mg/day for risperidone , and 15.3 mg/day for olanzapine ; 98.3 % of subjects were drug naive at baseline . Data from clinical measures of treatment response and tolerability and safety data from the 6-week acute phase of a large epidemiologic and longitudinal ( February 2001 to February 2005 ) intervention program of first-episode psychosis ( schizophrenia spectrum disorders , DSM-IV criteria ) are reported . RESULTS All 3 treatments showed similar effectiveness in reducing the severity of general , negative , and positive symptomatology after 6 weeks of treatment , as reported by mean change in total Clinical Global Impressions-Severity of Illness scale , Brief Psychiatric Rating Scale ( BPRS ) , Scale for the Assessment of Positive Symptoms , and Scale for the Assessment of Negative Symptoms scores between baseline and 6 weeks . The proportion of study subjects responding , defined as 40 % or greater BPRS total score improvement from baseline , was 57.1 % ( N = 32 of 56 ) haloperidol , 52.5 % ( N = 32 of 61 ) risperidone , and 63.6 % ( N = 35 of 55 ) olanzapine , with no statistical differences among groups . The frequency of extrapyramidal symptoms ( chi(2 ) = 24.519 ; p < .001 ) and concomitant anticholinergic medication use ( chi(2 ) = 57.842 ; p < .0001 ) was greater with haloperidol than olanzapine or risperidone . Olanzapine-treated patients had significantly more weight gain compared with the haloperidol and risperidone groups ( p < .001 ) . CONCLUSION Relatively low doses of haloperidol , risperidone , and olanzapine are equally effective for the acute treatment of first-episode nonaffective psychosis under usual conditions of real clinical practice OBJECTIVE This study examined the treatment response of patients with first-episode schizophrenia and schizoaffective disorder and potential predictors of response . METHOD First-episode patients were assessed on measures of psychopathology , cognition , social functioning , and biological parameters and treated according to a st and ardized algorithm . R
Output:
| Olanzapine was superior to haloperidol and risperidone for reduction of negative symptoms .
Several second-generation antipsychotics were superior to haloperidol in terms of all-cause discontinuation .
Olanzapine was associated with at least one use of drugs to treat parkinsonian symptoms and quetiapine with less akathisia than haloperidol , aripiprazole , risperidone , and olanzapine , but , again , evidence was very low to low quality .
Molindone was superior to risperidone , haloperidol , and olanzapine in terms of weight gain , and superior to risperidone in terms of increase in prolactin release .
INTERPREATION Haloperidol seems to be a suboptimum treatment option for acute treatment of first-episode schizophrenia , but we found little difference between second-generation antipsychotics . |
MS211811 | ***TASK*** the task is to summarize an input biomedical literature 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 Great Taste , Less Waste ( GTLW ) , a communications campaign , capitalized on the synergy between healthy eating and eco-friendly behaviors to motivate children to bring more fruits and vegetables and fewer sugar-sweetened beverages ( SSBs ) to school . METHODS A cluster-r and omized trial in Eastern Massachusetts elementary schools in 2011 - 2012 tested the hypothesis that GTLW would improve the quality of foods from home more than a nutrition-only campaign -- Foods 2 Choose (F2C)--or control . Lunch and snack items from home were measured at baseline and 7 months later using digital photography . Mixed linear models compared change in mean servings of fruits , vegetables , and SSBs among groups , and change in mean prevalence of packaging type . Change in prevalence of food items of interest was compared among groups using generalized linear models . RESULTS Five hundred and eighty-two third and fourth grade rs from 82 classrooms in 12 schools participated . At follow-up , no significant differences were observed between groups in change in mean servings or change in prevalence of items of interest . No packaging differences were observed . CONCLUSION GTLW was well received , but no significant changes were observed in the quality of food brought to school . Whether classrooms are an effective environment for change remains to be explored . Clinical Trials.gov identifier : NCT0157384 Aims : The aim of this pilot study was to investigate the feasibility and effectiveness of placing water coolers on sugar-sweetened beverage sales at secondary schools ( age 12–18 years ) in the city of Zwolle , the Netherl and s. Methods : Six schools , hosting 5,866 pupils , were divided in three intervention and three control schools . In the intervention schools , water coolers were placed in the canteen . Hidden observations were performed in one school to study the intervention ’s feasibility , and school personnel was interviewed . Beverage sales were monitored before and during the intervention . After the intervention period , 366 class 1 and 2 pupils completed a question naire about their drinking habits ( response rate 81 % ) . Results : Placement of water coolers appeared to be a feasible intervention at secondary schools . However , it did not affect sales of sugar-sweetened beverages at schools . Although mean intake of sugar-sweetened beverages at school was high , more than 500 ml/day for boys , and more than 250 ml/day for girls , only a minority of these quantities was purchased at school . Conclusion : We conclude that placing water coolers as a single-issue intervention in secondary school canteens should not be prioritized in the combat against obesity Background The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health . In 2005 a prevention protocol was developed applicable within Youth Health Care . This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children . Methods and design A cluster r and omised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams r and omised within 9 Municipal Health Services . The teams are r and omly allocated to the intervention or control group . The teams measure the weight and height of all children . When a child in the intervention group is detected with overweight according to the international age and gender specific cut-off points of BMI , the prevention protocol is applied . According to this protocol parents of overweight children are invited for up to three counselling sessions during which they receive personal advice about a healthy lifestyle , and are motivated for and assisted in behavioural change . The primary outcome measures are Body Mass Index and waist circumference of the children . Parents will complete question naires to assess secondary outcome measures : levels of overweight inducing/reducing behaviours ( i.e. being physically active , having breakfast , drinking sweet beverages and watching television/playing computer games ) , parenting styles , parenting practice s , and attitudes of parents regarding these behaviours , health-related quality of life of the children , and possible negative side effects of the prevention protocol . Data will be collected at baseline ( when the children are aged 5 years ) , and after 12 and 24 months of follow-up . Additionally , a process and a cost-effectiveness evaluation will be conducted . Discussion In this study called ' Be active , eat right ' we evaluate an overweight prevention protocol for use in the setting of Youth Health Care . It is hypothesized that the use of this protocol will result in a healthier lifestyle of the children and an improved BMI and waist circumference . Trial registration Current Controlled Trials IS RCT OBJECTIVE . The study tested whether a combined environmental and educational intervention solely promoting water consumption was effective in preventing overweight among children in elementary school . METHODS . The participants in this r and omized , controlled cluster trial were second- and third- grade rs from 32 elementary schools in socially deprived areas of 2 German cities . Water fountains were installed and teachers presented 4 prepared classroom lessons in the intervention group schools ( N = 17 ) to promote water consumption . Control group schools ( N = 15 ) did not receive any intervention . The prevalence of overweight ( defined according to the International Obesity Task Force criteria ) , BMI SD scores , and beverage consumption ( in glasses per day ; 1 glass was defined as 200 mL ) self-reported in 24-hour recall question naires , were determined before ( baseline ) and after the intervention . In addition , the water flow of the fountains was measured during the intervention period of 1 school year ( August 2006 to June 2007 ) . RESULTS . Data on 2950 children ( intervention group : N = 1641 ; control group : N = 1309 ; age , mean ± SD : 8.3 ± 0.7 years ) were analyzed . After the intervention , the risk of overweight was reduced by 31 % in the intervention group , compared with the control group , with adjustment for baseline prevalence of overweight and clustering according to school . Changes in BMI SD scores did not differ between the intervention group and the control group . Water consumption after the intervention was 1.1 glasses per day greater in the intervention group . No intervention effect on juice and soft drink consumption was found . Daily water flow of the fountains indicated lasting use during the entire intervention period , but to varying extent . CONCLUSION . Our environmental and educational , school-based intervention proved to be effective in the prevention of overweight among children in elementary school , even in a population from socially deprived areas OBJECTIVES The objectives of this pilot study were to compare the dietary , physiological and metabolic effects of 12-week modified carbohydrate nutrition intervention when disseminated in an individualized home-based format versus a group classroom-based format . METHODS Twenty-three overweight ( > /=85(th ) percentile BMI ) Latina adolescent females ( 12 - 17 years of age ) were r and omized to a 12-week modified carbohydrate dietary intervention delivered in either an individualized home-based format ( n = 11 ) or a group classroom-based format ( n = 12 ) . Anthropometrics , dietary intake by 3-day diet records , insulin dynamics by extended 3-hour Oral Glucose Tolerance test ( OGTT ) and body composition by Dual energy X-ray absorptiometry ( DXA ) were measured before and after intervention ; 24-hour diet recalls were collected once or twice per month throughout the program . RESULTS Mixed modeling showed no significant differences in changes in dietary intake between intervention groups , but both groups significantly reduced intake of added sugar , sugary beverages and refined carbohydrates by 33 % , 66 % , and 35 % , respectively , and dietary fiber significantly increased by 44 % ( p < 0.01 ) throughout the 12 weeks . There was a significant time effect for BMI z-scores within each intervention group ( p < 0.05 ) . There was no significant time*intervention group interaction for any of the physiological or metabolic variables , indicating that change over time was not significantly different between intervention groups . CONCLUSIONS Although a culturally tailored , modified carbohydrate dietary intervention led to significant improvements in dietary intake and BMI z-scores , the extremely intensive , individualized , home-based program was no more effective at improving diet , decreasing adiposity or reducing type 2 diabetes risk factors than the traditional classroom-based format BACKGROUND Secondary school students often do not drink sufficient quantities of water during the school day to prevent dehydration , promote learning and good health . The study aim ed to measure the effect of health promotion and the free provision of cooled filtered water on the consumption of water and soft drinks . It also aim ed to explore students ' views of drinking water provision . METHODS A study was conducted with three secondary schools in North Tyneside . Over a 3 month period one school was given cooled filtered water and active promotion ( W + P ) , another had water only ( W ) . The control school ( C ) took part in post-intervention focus group work . RESULTS The average volume of water drunk by students , in school ' W + P ' was greater ( P = 0.05 ) than that drunk in school ' W ' and control school ' C ' . The volume of soft drinks purchased by students in all three schools before and during the intervention remained static . Focus group data revealed that students viewed their existing water provision as poor and wanted sufficient supplies of cooled filtered water in school . CONCLUSIONS This pilot study indicates that active promotion of water drinking increased consumption of water by secondary school students . Further developments of the project are suggested Background Computer tailoring may be a promising technique for prevention of overweight in adolescents . However , very few well-developed , evidence -based computer-tailored interventions are available for this target group . We developed and evaluated a computer-tailored intervention for adolescents targeting energy balance-related behaviours : i.e. consumption of snacks , sugar-sweetened beverages , fruit , vegetables , and fibre , physical activity , and sedentary behaviours . This paper describes the planned development of a school-based computer-tailored intervention aim ed at improving energy balance-related behaviours in order to prevent excessive weight gain in adolescents , and the protocol for evaluating this intervention . Methods / design Intervention development : Informed by the Pre caution Adoption Process Model and the Theory of Planned Behaviour , the computer-tailored intervention provided feedback on personal behaviour and suggestions on how to modify it . The intervention ( VETisnietVET translated as ' FATaintPHAT ' ) has been developed for use in the first year of secondary school during eight lessons . Evaluation design : The intervention will be evaluated in a cluster-r and omised trial including 20 schools with a 4-months and a 2-years follow-up . Outcome measures are BMI , waist circumference , energy balance-related behaviours , and potential determinants of these behaviours . Process measures are appreciation of and satisfaction with the program , exposure to the program 's content , and implementation facilitators and barriers measured among students and teachers . Discussion This project result ed in a theory and evidence -based intervention that can be implemented in a school setting . A large-scale r and omised controlled trial with a short and long-term follow-up will provide sound statements about the effectiveness of this computer-tailored intervention in adolescents . Trial Registration IS RCT OBJECTIVE To explore whether the effects on dietary behaviours of a computer-tailored intervention aim ed to prevent excessive weight gain among adolescents , FATaintPHAT , were moderated by sociodemographic , cognitive and home environmental factors . DESIGN A two-group cluster r and omized trial . Potential moderation of the outcome measures ( consumption of sugar-sweetened beverages , snacks , fruits and vegetables ) was studied by gender , education level , ethnicity , awareness of risk behaviour , intention and home availability . SETTING Twenty schools in the Netherl and s. SUBJECTS Students ( n 883 ) aged 12 - 13 years . RESULTS Of the twenty-four interactions tested , only three were significant . The intervention effect on sugar-sweetened beverages was moderated by level of education ( P = 0·009 ) ; intervention effects were found only among academic preparatory students . The intervention effects on fruit and vegetable intake were moderated by awareness of fruit intake ( P < 0·001 ) and home availability of vegetables ( P = 0·007 ) ; an effect on fruit intake was found only among students who were aware of their low fruit intake at baseline and an effect on vegetable consumption was found only among students who reported that vegetables were always available at their home . CONCLUSIONS The effects of the intervention generally did not differ between sociodemographic subgroups . The moderation by home availability illustrates that the environment may influence the effects of educational interventions BACKGROUND During the nutrition transition in Chile , dietary changes were marked by increased consumption of high-energy , nutrient-poor products , including sugar-sweetened beverages ( SSBs ) . Obesity is now the primary nutritional problem in posttransitional Chile . OBJECTIVE We conducted a r and omized controlled trial to examine the effects on body composition of delivering milk beverages to the homes of overweight and obese children to displace SSBs . DESIGN We r and omly assigned 98 children aged 8 - 10 y who regularly consumed SSBs to intervention and control groups . During a 16-wk intervention , children were instructed to drink 3 servings/d ( approximately 200 g per serving ) of the milk delivered to their homes and to not consume SSBs . Body composition was measured by dual-energy X-ray absorptiometry . Data were analyzed by multiple regression analysis according to the intention-to-treat principle . RESULTS For the intervention group , milk consumption increased by a mean ( + /- SEM ) of 452.5 + /- 37.7 g/d ( P < 0.0001 ) , and consumption of SSBs decreased by -711.0 + /- 33.7 g/d
Output:
| Adoption , implementation , and maintenance reporting did not vary among levels . |
MS211812 | ***TASK*** the task is to summarize an input biomedical literature 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: & NA ; The placebo effect of transcutaneous electrical stimulation was studied in 93 patients in a double‐blind cross‐over trial using a genuine stimulator and a placebo machine . Placebo analgesic effects occurred in 32 % of trials , as compared with 48 % for actual stimulation . The placebo effect of the transcutaneous electrical stimulator is similar to the placebo effect that is noted in other double‐blind studies in which medicationms are used BACKGROUND AND PURPOSE The prescriptive validity of a treatment-oriented extension-mobilization category for patients with low back syndrome ( LBS ) was examined . SUBJECTS Of a total of 39 patients with LBS referred for physical therapy , 24 patients ( 14 male , 10 female ) , aged 14 to 50 years ( means = 31.3 , SD = 11.6 ) , were classified as having signs and symptoms indicating treatment with an extension-mobilization approach . The remaining subjects were dismissed from the study . Patients in the extension-mobilization category were r and omly assigned to either an experimental ( treatment ) group ( n = 14 ) or a comparison group ( n = 10 ) . METHODS The experimental and comparison group subjects were treated with either mobilization and extension ( a treatment matched to the category ) or a flexion exercise regimen ( an unmatched treatment ) . Outcome was assessed with a modified Oswestry Low Back Pain Question naire administered initially and at 3 and 5 days after initiation of treatment . Data were analyzed with a 2 x 3 ( treatment group x treatment period ) analysis of variance . RESULTS The subjects ' rate of improvement , as indicated by the Oswestry question naire scores , was dependent on the treatment group to which they were assigned . Subjects treated with extension and mobilization positively responded at a faster rate than did those treated with a flexion-oriented program . CONCLUSION AND DISCUSSION This study illustrates that a priori classification of selected patients with LBS into a treatment category of extension and mobilization and subsequently treating the patients accordingly with specified interventions can be an effective approach to conservative management of selected patients Therapeutic trials often attempt to “ blind ” patient and investigator to the true nature of treatments received , reducing the influences of conscious or subconscious prejudices . In drug trials , this is accomplished with placebo tablets , but blinding in trials of physical treatments is more problematic . This issue arose in a clinical trial of transcutaneous electrical nerve stimulation ( TENS ) for patients with chronic low back pain . Several study design features were incorporated to promote blinding : use of sham TENS units visually identical with real units , exclusion of potential subjects with previous TENS experience , avoidance of a crossover design and use of identical visit frequency , instructions and modifications in electrode placement . Subjects were asked not to discuss treatments with the clinicians who performed outcome assessment s. Both patients and clinicians were asked to guess actual treatment assignments at the trial 's end . Every patient in the true TENS group believed the unit was functioning properly , but the degree of certainty varied . In the sham TENS group , 84 % also believed they had functioning units , but their certainty was significantly less than in the active treatment group . Differences in patient perceptions did not affect compliance , as the two groups had similar dropout rates , appointment compliance , days of TENS use and daily duration of TENS use . Clinicians guessed treatments correctly 61 % of the time ( as opposed to 50 % expected by chance ) , again suggesting partial success in blinding . These efforts at blinding may partly explain the negative trial results for TENS efficacy . We conclude that complete blinding is difficult to achieve because of sensory difference in treatment and unintended communication between patient and examiner . Nonetheless , trials of physical treatments can achieve partial blinding with the techniques described here , and the success of blinding can be assessed with simple questions at study completion OBJECTIVES To determine the efficacy of a complementary analgesic modality , percutaneous electrical nerve stimulation ( PENS ) , for the treatment of chronic low back pain ( CLBP ) in community-dwelling older adults . DESIGN R and omized , controlled clinical trial . SETTING University of Pittsburgh Pain Evaluation and Treatment Institute . PARTICIPANTS Thirty-four English speaking , community-dwelling adults aged 65 and older with CLBP of at least moderate intensity experienced every day or almost every day . INTERVENTION Subjects were r and omized to receive twice-weekly PENS and physical therapy ( PT ) or sham PENS and physical therapy for 6 weeks . MEASUREMENTS At baseline , immediately after the 6-week intervention period , and 3 months later , the primary outcome measures pain intensity and pain-related disability were assessed . The secondary outcome measures physical performance ( timed chair rise , functional reach , gait speed , static and isoinertial lifting ) , psychosocial factors ( mood , sleep , and life control ) , and cognitive function ( measures of attention , concentration , and mental flexibility ) were also collected . RESULTS Subjects r and omized to PENS plus PT displayed significant reductions in pain intensity measures from pre- to posttreatment ( P < .001 ) , but the sham PENS plus PT group did not ( P = .94 ) . These pain reduction effects were maintained at 3-month follow-up . Similarly , significant reductions in pain-related disability were observed at posttreatment ( P = .002 ) for the PENS plus PT group and were maintained at follow-up , but the sham PENS plus PT group did not show reductions in pain-related disability ( P = .81 ) . Of the secondary outcome measures , psychosocial function , timed chair rise , and isoinertial lifting endurance also improved significantly at posttreatment for the PENS plus PT group , and their improvement was sustained at 3-month follow-up , but the sham PENS plus PT did not display significant changes on these measures after treatment . CONCLUSION This preliminary study suggests that PENS may be a promising treatment modality for community-dwelling older adults with CLBP , as demonstrated by reduction in pain intensity and self-reported disability , and improvement in mood , life control , and physical performance . Larger studies with longer duration of follow-up are needed to vali date these findings and support the use of PENS in clinical practice OBJECTIVE To investigate to what extent a single 60-minute session of transcutaneous electrical nerve stimulation ( TENS ) would modify chronic clinical pain , acute experimental pain , and the flexion reflex evoked in chronic low back pain patients . STUDY DESIGN Thirty young subjects with chronic low back pain were r and omly allocated to two groups , receiving either TENS or placebo stimulation to the lumbosacral region for 60 minutes . The flexion reflex was elicited by an electrical stimulation applied to the subject 's right sole and recorded electromyographically from the biceps femoris and the tibialis anterior muscles . MAIN OUTCOME MEASURES Subjective sensation of low back pain and the electrically induced pain were measured by two separate visual analog scales , termed VAS(LBP ) and VAS(FR ) , respectively . Data obtained before , during , and 60 minutes after TENS and placebo stimulations were analyzed using repeated measures ANOVA . RESULTS The VAS(LBP ) score was significantly reduced to 63.1 % of the prestimulation value after TENS ( p<.001 ) , but the reduction was negligible after placebo stimulation ( to 96.7 % , p = .786 ) . In contrast , no significant change was found in the VASFR score ( p = .666 ) and the flexion reflex area ( p = .062 ) during and after stimulation within each group and between the two groups ( p = .133 for VASFR and p = .215 for flexion reflex area ) . CONCLUSIONS The same TENS protocol had different degrees of antinociceptive influence on chronic and acute pain in chronic low back pain patients BACKGROUND Electrical stimulation of peripheral nerves produces acute analgesic effects . This r and omized , sham-controlled , crossover study was design ed to evaluate the effect of differing duration s of electrical stimulation on the analgesic response to percutaneous electrical nerve stimulation in 75 consenting patients with low back pain . METHODS All patients received electrical stimulation for four different time intervals ( 0 , 15 , 30 , and 45 min ) in a r and om sequence over the course of an 11-week study period . All active percutaneous electrical nerve stimulation treatments were administered using alternating frequencies of 15 and 30 Hz three times per week for 2 consecutive weeks . The pre study assessment s included the health status survey short form question naire and 10-cm visual analog scale scores for pain , physical activity , and quality of sleep , with 0 being the best and 10 being the worst . The pain scoring was repeated 5 - 10 min after each 60-min study session and 24 h after the last treatment session with each of the four methods . The daily oral analgesic requirements were assessed during each of the four treatment blocks . At the end of each 2-week treatment block , the question naire was repeated . RESULTS Electrical stimulation using percutaneously placed needles produced short-term improvements in the visual analog scale pain , physical activity , and quality of sleep scores , and a reduction in the oral analgesic requirements . The 30-min and 45-min duration s of electrical stimulation produced similar hypoalgesic effects ( 48+/-21 % and 46+/-19 % , respectively ) and were significantly more effective than either 15 min ( 21+/-17 % ) or 0 min ( 10+/-11 % ) . The 30- and 45-min treatments were also more effective in improving physical activity and sleep scores over the course of the 2-week treatment period . In contrast to the sham treatment ( 0 min ) , the health status survey short form revealed that electrical stimulation for 15 to 45 min three times per week for 2 weeks improved patient function . CONCLUSION The recommended duration of electrical stimulation with percutaneous electrical nerve stimulation therapy is 30 min & NA ; It has recently been shown that ice massage of the web between the thumb and index finger produces significantly greater relief of dental pain than a placebo control procedure . These results indicate that ice massage may be comparable to transcutaneous electrical stimulation ( TES ) and acupuncture , and may be mediated by similar neural mechanisms . The purpose of this study was to examine the relative effectiveness of ice massage and TES for the relief of low‐back pain . Patients suffering chronic low‐back pain were treated with both ice massage and TES . The order of treatments was balanced , and changes in the intensity of pain were measured with the McGill Pain Question naire ( MPQ ) . The results show that both methods are equally effective : based on the Pain Rating Index of the MPQ , 67–69 % of patients obtained pain relief greater than 33 % with each method . The results indicate that ice massage is an effective therapeutic tool , and appears to be more effective than TES for some patients . It may also serve as an additional sensory‐modulation method to alternate with TES to overcome adaptation effects . Evidence that cold signals are transmitted to the spinal cord exclusively by A‐delta fibers and not by C fibers suggests that ice massage provides a potential method for differentiating among the multiple feedback systems that mediate analgesia produced by different forms of intense sensory input A prospect i ve , r and omized , double-blind , placebo-controlled clinical trial was performed to investigate the efficacy of electrical muscle stimulation when combined with a therapist-guided , st and ardized exercise therapy program in the treatment of nonacute low back pain . Eighty patients with low back pain of at least 6 weeks ' duration were r and omized into the following 2 groups : st and ardized exercise therapy with functional electrical muscle stimulation or st and ardized exercise therapy with placebo electrical stimulation . Subjects were evaluated at baseline , 2 months , and 6 months with a st and ardized back pain question naire and objective measurements of lumbar spine function . Exercise therapy was continued for 6 months , but electrical stimulation was discontinued at the 2-month interval . Of the 80 patients initially enrolled , 42 discontinued or withdrew before completing the entire study protocol . At the 2-month follow-up interval , subjects in the treatment group had statistically significantly improved lumbar spine function compared with the control subjects . This effect continued during the last 4 months of the study after electrical stimulation had been discontinued . This suggests that electrical muscle stimulation can be an effective adjunctive treatment modality for nonacute low back pain . The effects of this combined therapy seem to last beyond the duration of electrical stimulation treatment Patients with acute or chronic low back pain were treated in a double-blind study that compared transcutaneous electrical nerve stimulation at intense levels and gentle , mechanically administered massage . Transcutaneous electrical nerve stimulation produced significantly greater pain relief , based on two measures of the McGill Pain Question naire , and significant improvement in straight leg raising . There were no significant differences between the two groups in backflexion scores . Pain-relief scores and range-of-motion scores were significantly correlated . The results indicate that pain-relief scores provide valuable information and can easily be obtained from patients for whom pain is a major symptom STUDY DESIGN A r and omized trial design ed to compare interferential therapy with motorized lumbar traction and massage management for low back pain in a primary care setting . OBJECTIVE To measure and compare the outcome of interferential therapy and management by motorized lumbar traction and massage . SUMMARY OF BACKGROUND DATA Management of low back pain by interferential therapy and motorized lumbar traction and massage is common in Germany . No reports of previous r and omized trials for the outcome from interferential therapy were found . METHODS Consenting patients were r and omly assigned into one of two groups . A pretreatment interview was performed by the patient using a computer-based question naire . It also incorporated the Oswestry Disability Index and a pain visual
Output:
| However , in the other RCT , no statistically significant differences between treatment and control groups were shown for multiple outcome measures .
There is inconsistent evidence to support the use of TENS as a single treatment in the management of chronic LBP . |
MS211813 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Recent reports have drawn attention to the importance of pulse pressure as a predictor of cardiovascular events . Pulse pressure is used neither by clinicians nor by guidelines to define treatable levels of blood pressure . METHODS In the Cardiovascular Health Study , 5888 adults 65 years and older were recruited from 4 US centers . At baseline in 1989 - 1990 , participants underwent an extensive examination , and all subsequent cardiovascular events were ascertained and classified . RESULTS At baseline , 1961 men and 2941 women were at risk for an incident myocardial infa rct ion or stroke . During follow-up that averaged 6.7 years , 572 subjects had a coronary event , 385 had a stroke , and 896 died . After adjustment for potential confounders , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , and pulse pressure were directly associated with the risk of incident myocardial infa rct ion and stroke . Only SBP was associated with total mortality . Importantly , SBP was a better predictor of cardiovascular events than DBP or pulse pressure . In the adjusted model for myocardial infa rct ion , a 1-SD change in SBP , DBP , and pulse pressure was associated with hazard ratios ( 95 % confidence intervals ) of 1.24 ( 1.15 - 1.35 ) , 1.13 ( 1.04 - 1.22 ) , and 1.21 ( 1.12 - 1.31 ) , respectively ; and adding pulse pressure or DBP to the model did not improve the fit . For stroke , the hazard ratios ( 95 % confidence intervals ) were 1.34 ( 1.21 - 1.47 ) with SBP , 1.29 ( 1.17 - 1.42 ) with DBP , and 1.21 ( 1.10 - 1.34 ) with pulse pressure . The association between blood pressure level and cardiovascular disease risk was generally linear ; specifically , there was no evidence of a J-shaped relationship . In those with treated hypertension , the hazard ratios for the association of SBP with the risks for myocardial infa rct ion and stroke were less pronounced than in those without treated hypertension . CONCLUSION In this population -based study of older adults , although all measures of blood pressure were strongly and directly related to the risk of coronary and cerebrovascular events , SBP was the best single predictor of cardiovascular events The effect of conventional propranolol and bendrofluazide tablets given twice daily has been compared with an equivalent dosage combined in a single capsule given twice daily in fourteen patients with essential hypertension . Good blood pressure control was achieved on both regimes in the majority of patients and there was no significant difference in treatment response between the two regimes . Use of the combined capsule is convenient and may improve patient compliance BACKGROUND Short-term studies have suggested that the use of initial combination therapy for the control of blood pressure improves early effectiveness . We tested whether a combination of aliskiren and amlodipine is superior to each monotherapy in early control of blood pressure without excess of adverse events , and if initial control by monotherapy impairs subsequent control by combination therapy . METHODS We did a double-blind , r and omised , parallel-group , superiority trial at 146 primary and secondary care sites in ten countries , with enrolment from Nov 28 , 2008 , to July 15 , 2009 . Patients eligible for enrolment had essential hypertension , were aged 18 years or older , and had systolic blood pressure between 150 and 180 mm Hg . Patients were r and omly assigned ( 1:1:2 ) to treatment with 150 mg aliskiren plus placebo , 5 mg amlodipine plus placebo , or 150 mg aliskiren plus 5 mg amlodipine . R and om assignment was through a central interactive voice response system and treatment allocation was masked from the patients . From 16 - 32 weeks , all patients received combination therapy with 300 mg aliskiren plus 10 mg amlodipine . Our primary endpoints , assessed on an intention-to-treat basis ( ie , in patients who received the allocated treatment ) , were the adjusted mean reduction in systolic blood pressure from baseline over 8 to 24 weeks , and then the final reduction at 24 weeks . This trial is registered with Clinical Trials.gov , number NCT00797862 . FINDINGS 318 patients were r and omly assigned to aliskiren , 316 to amlodipine , and 620 to aliskiren plus amlodipine . 315 patients initially allocated to aliskiren , 315 allocated to amlodipine , and 617 allocated to aliskiren plus amlodipine were available for analysis . Patients given initial combination therapy had a 6·5 mm Hg ( 95 % CI 5·3 to 7·7 ) greater reduction in mean systolic blood pressure than the monotherapy groups ( p<0·0001 ) . At 24 weeks , when all patients were on combination treatment , the difference was 1·4 mm Hg ( 95 % CI -0·05 to 2·9 ; p=0·059 ) . Adverse events caused withdrawal of 85 patients ( 14 % ) from the initial aliskiren plus amlodipine group , 45 ( 14 % ) from the aliskiren group , and 58 ( 18 % ) from the amlodipine group . Adverse events were peripheral oedema , hypotension , or orthostatic hypotension . INTERPRETATION We believe that routine initial reduction in blood pressure ( > 150 mm Hg ) with a combination such as aliskiren plus amlodipine can be recommended . FUNDING Novartis Pharma AG ABSTRACT Objective : Free combination hypertension medication is associated with a lower compliance and less persistence compared to fixed combination therapy and can , therefore , be associated with insufficient blood pressure reductions . This non-r and omized study investigated whether valsartan 160 mg/ hydrochlorothiazide 25 mg ( Val 160/HCTZ 25 ) in fixed dose combination could provide additional blood pressure control in hypertensive patients not adequately controlled by the free combination of c and esartan 32 mg plus HCTZ 25 mg . Research design and methods : One hundred and ninety-seven patients with a mean sitting diastolic blood pressure ( MSDBP ) between 100 and 110 mmHg entered a 4-week treatment phase with 32 mg of c and esartan in free combination with 25 mg of HCTZ once daily . One hundred and thirty-eight patients with uncontrolled BP at Week 4 , entered a second 4-week treatment phase with Val160/ HCTZ 25 once daily . Main outcome measures : The primary efficacy parameter was the reduction in MSDBP at trough between Week 4 and Week 8 in the intent-to-treat population . Results : At baseline , MSDBP was 103.0 ± 2.8 mmHg . After Week 4 , MSDBP had decreased to 93.8 ± 4.5 mmHg . Subsequent treatment with Val 160/HCTZ 25 for 4 weeks reduced MSDBP to 88.7 ± 8.6 mmHg . This represented an additional decrease in MSDBP of 5.1 ± 7.9 mmHg ( p < 0.0001 ) . Val 160/ HCTZ 25 reduced mean sitting systolic BP by 3.4 ± 13.0 mmHg ( p = 0.0029 ) . Conclusions : The fixed dose combination of valsartan 160/HCTZ 25 mg provided a statistically and clinical ly significant additional BP reduction in patients not controlled by the free combination of c and esartan 32 mg and HCTZ 25 mg The importance of number of tablets for patient compliance was investigated in 160 patients with mild-moderate essential hypertension treated with a beta-adrenoceptor blocker and a thiazide diuretic . Mean BP at entry 146 + /- 16/92 + /- 8 mm Hg . All patients were given pindolol 10 mg and clopamide 5 mg in one combination tablet or in separate tablets for 4 months respectively . Approximately 90 % of the patients took greater than 90 % of the prescribed dose throughout the study . Mean BP decreased progressively and heart rate increased slightly . Side effects were more frequently reported during the first month of the study than previously , and 30 patients discontinued the treatment . No differences in this respect were seen between 1 and 2 tablets daily . Approximately 75 % of the patients preferred 1 tablet daily , but combining two drugs in one tablet had no effect upon compliance OBJECTIVES To assess medication adherence , persistence , and costs between cohorts of patients in managed care setting s using a fixed-dose combination ( FDC ) or individual components ( IC ) of valsartan and hydrochlorothiazide in an insurance cl aims data base . METHODS Medical and prescription cl aims for hypertensive patients using a combination of valsartan and HCTZ were identified from the IHCIS National Managed Care Benchmark Data base via a retrospective cohort analysis . Study subjects had at least 110 days prior to start of study medications during which no other antihypertensive medications were prescribed , and were followed for 12 months . Cl aims for 8711 adult patients were analyzed for adherence , persistence and costs . General linear regression was conducted to detect differences in adherence among groups . Covariates included age , gender , persistence , number on concomitant cardiovascular drugs , and number of cardiovascular diagnoses . RESULTS Most subjects used an FDC product ( N=8150 , 93.6 % ) vs. the IC ( N=561 , 6.4 % ) . The FDC group had a larger portion of males and less concomitant cardiovascular medications or disease . A r and om sample of 1628 of the FDC subjects had improved values for medication adherence compared to the IC group ( 62.1 vs. 53.0 % , p<0.001 ) and persistence values were improved at both 180 days ( 73 vs. 28 % , p<0.001 ) and 365 days ( 54 vs. 19 % , p<0.001 ) . Both prescription drug costs ( $ 1587 vs. $ 2050 , p<0.001 ) and medical costs ( $ 3343 vs. $ 3817 , p<0.001 ) were lower in the FDC cohorts . CONCLUSIONS The use of fixed-dose therapy in hypertension may lead to increased adherence and persistence with a positive financial impact on both prescription and total medical costs . As with any retrospective cl aims data base analysis , unobserved systematic differences between the two medication groups may exist 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 Background and Purpose — The benefits of antihypertensive ( AH ) drugs on the risks of major cardiovascular outcomes have been demonstrated in clinical trials . However , approximately half of hypertensive patients do not adhere well to their prescribed AH therapy in actual practice . The purpose of this study was to assess the impact of adherence to AH agents on the incidence of cerebrovascular disease ( CD ) in real-world practice . Methods — A cohort of 83 267 hypertensive patients was reconstructed from the Régie de l'assurance maladie du Québec data bases . Subjects included were between 45 and 85 years old , initially free of cardiovascular disease , and newly treated for hypertension with AH agents between 1999 and 2004 . A nested case – control design was conducted to study CD occurrence . Every case was matched for age and duration of follow-up with up to 15 r and omly selected control subjects . The adherence to AH drugs was measured by calculating the medication possession ratio . Conditional logistic regression models were performed to assess the association between adherence to AH agents and CD adjusting for various potential confounders . Results — At cohort entry , the mean patient age was 65 years , 37.3 % were male , 8.6 % had diabetes , and 19.5 % had dyslipidemia . High adherence ( ≥80 % ) to AH drugs significantly decreased the risk of CD by 22 % ( rate ratio , 0.78 ; 95 % CI , 0.70 to 0.87 ) compared with lower adherence
Output:
| For endpoints correlated with higher adherence ( e.g. , a reduction in blood pressure ) , a nonsignificant benefit was observed for FDCs .
Moreover , it was demonstrated that higher adherence can lead to a lower risk of cardiovascular events .
Conclusions In comparison with FECs , the FDC treatment is associated with a significant improvement in the cooperation between a doctor and a patient and with increased patients ' adherence to the treatment schedule |
MS211814 | ***TASK*** the task is to summarize an input biomedical literature 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 ADAGIO study investigated whether rasagiline has disease-modifying effects in Parkinson 's disease . Rasagiline 1 mg per day , but not 2 mg per day , was shown to be efficacious in the primary analysis . Here , we report additional secondary and post-hoc analyses of the ADAGIO study . METHODS ADAGIO was a placebo-controlled , double-blind , multicentre , delayed-start study , in which 1176 patients with untreated early Parkinson 's disease were r and omly assigned to receive rasagiline 1 mg or 2 mg per day for 72 weeks ( early-start groups ) or placebo for 36 weeks followed by rasagiline 1 mg or 2 mg per day for 36 weeks ( delayed-start groups ) . We assessed the need for additional antiparkinsonian therapy and changes in non-motor experiences of daily living and fatigue scales ( prespecified outcomes ) and changes in unified Parkinson 's disease rating scale ( UPDRS ) scores and subscores in placebo and active groups ( post-hoc outcomes ) . The ADAGIO study is registered with Clinical Trials.gov , number NCT00256204 . FINDINGS The need for additional antiparkinsonian therapy was reduced with rasagiline 1 mg ( 25 of 288 [ 9 % ] patients ) and 2 mg ( 26 of 293 [ 9 % ] ) versus placebo ( 108 of 593 [ 18 % ] ; odds ratio for 1 mg rasagiline vs placebo 0·41 , 95 % CI 0·25 - 0·65 , p=0·0002 ; 2 mg rasagiline vs placebo 0·41 , 0·26 - 0·64 , p=0·0001 ) . At week 36 , both doses significantly improved UPDRS motor subscores compared with placebo ( 1 mg rasagiline mean difference -1·88 [ SE 0·35 ] ; 2 mg rasagiline -2·18 [ 0·35 ] ; both p<0·0001 ) and activities of daily living subscores ( ADL ; 1 mg rasagiline -0·86 [ 0·18 ] ; 2 mg rasagiline -0·88 [ 0·18 ] ; both p<0·0001 ) , and 1 mg rasagiline significantly improved UPDRS mentation subscore ( -0·22 [ 0·08 ] ; p=0·004 ) . At week 72 , the only significant difference between early-start and delayed-start groups was for ADL subscore with the 1 mg dose ( -0·62 [ 0·29 ] ; p=0·035 ) . When assessed for the effect on non-motor symptoms at week 36 , both doses showed benefits on the Parkinson fatigue scale versus placebo ( 1 mg rasagiline mean difference -0·14 [ SE 0·05 ] , p=0·0032 ; 2 mg rasagiline -0·19 [ 0·05 ] , p<0·0001 ) , and the 1 mg dose showed benefits on the scale for non-motor experiences of daily living compared with placebo ( mean difference -0·33 [ 0·17 ] ; p=0·049 ) . The rate of progression of total UPDRS score for patients in the placebo group was 4·3 points [ SE 0·3 ] over 36 weeks , with extrapolation to about 6 units per year . In the placebo group , patients with the lowest quartile of baseline UPDRS scores ( ≤14 ; n=160 ) progressed more slowly than did those with highest scores ( > 25·5 ; n=145 ; mean difference -3·46 [ SE 0·77 ] ; p<0·0001 ) . INTERPRETATION These findings show that rasagiline delayed the need for symptomatic antiparkinsonian drugs and emphasise the contribution of the UPDRS ADL in the response of the rasagiline 1 mg per day early-start versus delayed-start group . The rate of UPDRS deterioration was less than was anticipated from previous studies and correlated with baseline severity . Underst and ing of the pattern of UPDRS deterioration is essential to assess disease modification . FUNDING Teva Pharmaceutical Industries and H Lundbeck BACKGROUND AND PURPOSE Fatigue is a common and disabling non-motor symptom in Parkinson 's disease ( PD ) . The pathogenesis is unknown , and the treatment options are limited . The aim of the present study was to investigate the development of fatigue during the first year after diagnosis . METHODS The study design was a prospect i ve , controlled population -based longitudinal cohort study , comprising 181 de novo , drug-naïve patients with PD and 162 control participants . PD was diagnosed according to the Gelb criteria . Fatigue was assessed by the Fatigue Severity Scale ( FSS ) . Both groups were assessed for fatigue at baseline and after 1 year . RESULTS Patients reported more fatigue than the control subjects at baseline and at the 1-year follow-up evaluation . The FSS scores in the patient group improved from a mean score of 4.4 ( SD 1.6 ) to 4.0 ( SD 1.6 ) . Patients with fatigue at baseline received higher doses of dopaminergic medication during follow-up . Patients who received dopamine agonists improved slightly more than patients who received levodopa . A regression analysis did not show a correlation between an improvement in fatigue and a change in disease severity , depressive symptoms , sleep problems , apathy or cognitive impairment . CONCLUSION Fatigue is a common symptom in PD , also in early , untreated patients . During the first year of observation , an improvement in the fatigue scores was found . The improvement could not be attributed to a change in disease severity or depressive symptoms . The results indicate a better effect of dopamine agonists than of levodopa . This may have implication s for treatment in patients with PD-associated fatigue Objective : To evaluate if mental fatigue is a symptom that appears independently from other clinical features in patients with Parkinson disease ( PD ) , and to study if fatigue is persistent over time in these patients . Methods : In 1993 , 233 patients with PD were included in a community-based study of fatigue and followed prospect ively over 8 years . Fatigue was measured by a combination of a seven-point scale and parts of the Nottingham Health Profile ( NHP ) at baseline and after 4 and 8 years . In addition , the Fatigue Severity Scale ( FSS ) was used to evaluate fatigue in 2001 . Population -averaged logistic regression models for correlated data were performed to study the relationship between fatigue and various demographic and clinical variables . Results : In patients who were followed throughout the 8-year study period , fatigue increased from 35.7 % in 1993 to 42.9 % in 1997 and 55.7 % in 2001 . Fatigue was related to disease progression , depression , and excessive daytime sleepiness ( EDS ) . However , the prevalence of fatigue in patients without depression and EDS remained high and increased from 32.1 % to 38.9 % during the study period . For about 44 % of the patients with fatigue the presence of this symptom varied during the study period , as it was persistent in 56 % of the patients with fatigue . Conclusions : The authors confirmed the high prevalence of mental fatigue in patients with Parkinson disease ( PD ) . Fatigue is related to other non-motor features such as depression and excessive daytime sleepiness , but can not be explained by this comorbidity alone . In more than half of the patients mental fatigue is persistent and seems to be an independent symptom that develops parallel to the progressive neurodegenerative disorder of PD BACKGROUND Fatigue is one of the most disabling non-motor symptoms for people with Parkinson 's disease . Exercise may modify fatigue . This study examines prescribed exercise effects on physical activity levels , well-being , and fatigue in Parkinson 's disease . METHODS In this single-blinded trial , participants were r and omly assigned to either a 12 week community exercise program or control group . Primary outcome measures were fatigue ( Fatigue Severity Scale ) and physical activity . RESULTS Thirty-nine people with Parkinson 's disease were included : 20 in exercise and 19 in control . Sixty-five percent of the study group were fatigued ( n = 24 , mean 4.02 , SD 1.48 ) . Increased fatigue was associated with lower mobility and activity ( P < .05 ) . Individuals participated in a mean of 15 ( SD 10 ) exercise sessions with no significant change in fatigue , mobility , well-being , or physical activity after exercise ( P ≥ .05 ) . CONCLUSION Participation in weekly exercise did not improve fatigue in people with Parkinson 's Disease Objectives : Fatigue is common in Parkinson 's disease ( PD ) , causing serious negative effects on quality of life . Despite its clinical importance , the nature of fatigue in PD is poorly understood because its underlying neurobiology is unknown . Fatigue can be more complicated in advanced PD because of its chronicity . In order to find features that are innate to fatigue in PD , it would be useful to conduct a study looking at de novo PD . Assessing fatigue in de novo patients allows excluding at least one confounding factor . Methods : We prospect ively investigated 87 drug-naïve PD patients . Thirty-nine patients ( 44.8 % ) were found to have fatigue around the time of diagnosis of PD . Results : We found that depression and difficulties with activities of daily living were independent risk factors for fatigue ; however , motor dysfunction was not related . Clinical ly meaningful responses to dopaminergic medication were observed . Discussion : Our study determined that fatigue occurs in the early stages of PD . It can inform clinical decision-making to significantly benefit PD patients with fatigue BACKGROUND Fatigue affects 40 % to 50 % of all PD patients and is a leading cause of disability , with no clearly established or efficacious established treatments . METHODS In this double-blinded , placebo-controlled , pilot trial , we investigated whether rasagiline improved fatigue among PD patients . Subjects were r and omized to 1 mg daily of rasagiline or placebo for 12 weeks . The primary endpoint was a change in the Modified Fatigue Impact Scale from baseline to week 12 . RESULTS Thirty PD subjects ( 16 men ) , with Modified Fatigue Impact Scale baseline score of 67 ± 15 , were r and omized ( 16 to rasagiline vs. 14 to placebo ) . Significant improvement was noted in the mean Modified Fatigue Impact Scale score of the rasagiline group ( 12 points ) as compared to placebo ( 8.5 points ) from baseline to week 12 ( P = 0.003 ) . CONCLUSION In this pilot study , rasagiline at a dose of 1 mg per day improved fatigue . Larger r and omized studies are needed to confirm this finding OBJECTIVE To identify the motor and non-motor factors that are associated with health related quality of life ( HR-QOL ) in a subgroup of Parkinson 's disease ( PD ) patients with Levodopa therapy in early clinical stages . METHODS 391 Levodopa exposed patients were evaluated during the baseline assessment of a clinical trial in China . HR-QOL was measured by the Short Form 36 ( SF-36 ) . Motor and non-motor variables were determined during a structured interview and by clinical examination by movement disorder specialists . Multiple regression analyses were used to determine which variables were associated with low levels of HR-QOL . RESULTS Even if excluding non-motor variables from the regression model , motor factors , particularly motor deficits ( measured by motor score of UPDRS ) , rigidity ( measured by item 22 of UPDRS ) , and disease severity ( measured by Hoehn&Yahr scale ) , explained only 18.9 % of the variance of total SF-36 score . Whereas , when non-motor variables were included in the model , especially depression ( measured by CES-D ) , sleep disturbances ( measured by PSQ-I ) , and fatigue ( measured by FSS ) , 61.7 % of the variance of SF-36 score could be explained . Two motor variables , UPDRS motor score and Hoehn&Yahr score , were also contributed to the model , however , the 95 % confidence intervals ( CIs ) of these two motor factors were wide and included the null value ( CIs -0.282 , 0.019 for UPDRS motor score , and CIs -4.043 , 0.856 for Hoehn&Yahr score ) . Neither , did higher daily levodopa dose contribute significantly to both models predicting SF-36 score . CONCLUSIONS In our sample patients with levodopa therapy , motor disability and severity of parkinsonism contributed to a lesser extent to patients ' self-report distress , within the first 5 years of disease onset . The clinical factors that showed the highest predictive value for worsen HR-QOL were non-motor symptoms , such as depression , sleep disorders , and fatigue . Great effort should be made to recognize and treat those conditions , thus improving all aspects of PD and giving these patients as a good HR-QOL as possible Objectives : Fatigue is a complaint frequently encountered among patients with Parkinson ’s disease ( PD ) . Considering the possible relationship between fatigue and dopaminergic dysfuncion , we investigated the effect of pergolide mesilate ( a D2 and D1 dopamine receptor agonist ) and bromocriptine
Output:
| Our analyses suggest that fatigue is a frequent , independent nonmotor symptom in PD appearing early and persisting throughout the disease course , and that establishing uniform diagnostic criteria for PD-related fatigue is critical .
In addition , several nonmotor symptoms appear to be associated with fatigue and negatively impact quality of life .
Pharmacological and nonpharmacological interventions targeting fatigue and associated symptoms may improve quality of life in patients with PD . |
MS211815 | ***TASK*** the task is to summarize an input biomedical literature 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 Medical research must involve the participation of human subjects . Knowledge of patients ' perspectives and concerns with their involvement in research would enhance recruitment efforts , improve the informed consent process , and enhance the overall trust between patients and investigators . Several studies have examined the views of patients from Western countries . There is limited empirical research involving the perspectives of individuals from developing countries . The purpose of this study is to examine the attitudes of Egyptian individuals toward medical research . Such information would help clarify the type and extent of concerns regarding research participation of individuals from cultural , economic , and political background s that differ from those in developed countries . Methods We conducted semi-structured interviews with 15 Egyptian individuals recruited from the outpatient setting s ( public and private ) at Ain Shams University in Cairo , Egypt . Interviews were taped , transcribed , and translated . Thematic analysis followed . Results All individuals valued the importance of medical research ; however most would not participate in research that involved more than minimal risk . Individuals were comfortable with studies involving surveys and blood sampling , but many viewed drug trials as being too risky . All participants valued the concept of informed consent , as they thought that their permission to be in a research study was paramount . Many participants had discomfort with or difficulty in the underst and ing several research concepts : r and omization , double-blind , and clinical equipoise . Trust in the physicians performing research was important in deciding to participate in clinical research . The small sample size and the selection bias associated with obtaining information from only those who agreed to participate in a research study represent limitations in this study . Conclusion Overall , individuals in our sample recognize the value of medical research and have a great deal of trust regarding medical research and their participation in research . There were , however , concerns with the level of research risks associated with several types of medical research . Many also demonstrated confusion with certain research method ologies . We recommend 1 ) enhanced educational efforts regarding general research concepts to enhance the validity of informed consent and 2 ) further survey studies in other areas of Egypt to determine the generalizability of our results Introduction HIV epidemics in sub-Saharan Africa are generalized , but high-risk subgroups exist within these epidemics . A recent study among fisher-folk communities ( FFC ) in Ug and a showed high HIV prevalence ( 28.8 % ) and incidence ( 4.9/100 person-years ) . However , those findings may not reflect population -wide HIV rates in FFC since the study population was selected for high-risk behaviour . Methods Between September 2011 and March 2013 , we conducted a community-based cohort study to determine the population representative HIV rates and willingness to participate ( WTP ) in hypothetical vaccine trials among FFC , Ug and a. At baseline ( September 2011–January 2012 ) , a household enumeration census was done in eight fishing communities ( one lakeshore and seven isl and s ) , after which a r and om sample of 2200 participants aged 18–49 years was selected from 5360 individuals . Interviewer-administered question naire data were collected on HIV risk behaviours and WTP , and venous blood was collected for HIV testing using rapid HIV tests with enzyme-linked immunosorbent assay ( EIA ) confirmation . Adjusted prevalence proportion ratios ( adj . PPRs ) of HIV prevalence were determined using log-binomial regression models . Results Overall baseline HIV prevalence was 26.7 % and was higher in women than men ( 32.6 % vs. 20.8 % , p<0.0001 ) . Prevalence was lower among fishermen ( 22.4 % ) than housewives ( 32.1 % ) , farmers ( 33.1 % ) and bar/lodge/restaurant workers ( 37 % ) . The adj . PPR of HIV was higher among women than men ( adj . PPR = 1.50 , 95 % ; 1.20 , 1.87 ) and participants aged 30–39 years ( adj . PPR=1.40 , 95 % ; 1.10 , 1.79 ) and 40–49 years ( adj . PPR=1.41 , 95 % ; 1.04 , 1.92 ) compared to those aged 18–24 years . Other factors associated with HIV prevalence included low education , previous marriage , polygamous marriage , alcohol and marijuana use before sex . WTP in hypothetical vaccine trials was 89.3 % and was higher in men than women ( 91.2 % vs. 87.3 % , p=0.004 ) and among isl and communities compared to lakeshore ones ( 90.4 % vs. 85.8 % , p=0.004 ) . Conclusions The HIV prevalence in the general fisher-folk population in Ug and a is similar to that observed in the “ high-risk ” fisher folk . FFC have very high levels of willingness to participate in future HIV vaccine trials BACKGROUND In setting s where multiple HIV prevention trials are conducted in close proximity , trial participants may attempt to enroll in more than one trial simultaneously . Co-enrollment impacts on participant 's safety and validity of trial results . We describe our experience , remedial action taken , inter-organizational collaboration and lessons learnt following the identification of co-enrolled participants . EXPERIENCES Between February and April 2008 , we identified 185 of the 398 enrolled participants as ineligible . In violation of the study protocol exclusion criteria , there was simultaneous enrollment in another HIV prevention trial ( ineligible co-enrolled , n=135 ) , and enrollment of women who had participated in a microbicide trial within the past 12 months ( ineligible not co-enrolled , n=50 ) . Following a complete audit of all enrolled participants , ineligible participants were discontinued via study exit visits from trial follow-up . Custom- design ed education program on co-enrollment impacting on participants ' safety and validity of the trial results was implemented . Shared electronic data base between research units was established to enable verification of each volunteer 's trial participation and to prevent future co-enrollments . LESSONS LEARNT Interviews with ineligible enrolled women revealed that high- quality care , financial incentives , altruistic motives , preference for sex with gel , wanting to increase their likelihood of receiving active gel , perceived low risk of discovery and peer pressure are the reasons for their enrollment in the CAPRISA 004 trial . CONCLUSION Instituting education programs based on the reasons reported by women for seeking enrollment in more than one trial and using a shared central data base system to identify co-enrollments have effectively prevented further co-enrollments Background and Purpose — Most stroke rehabilitation studies have been performed in high-income countries . The aim of this study was to identify the main barriers for patient inclusion in a research protocol performed in Brazil . Methods — We evaluated reasons for exclusion of patients in a pilot , r and omized , double-blinded clinical trial of stroke rehabilitation . Descriptive statistical analysis was performed . Results — Only 5.6 % of 571 screened patients were included . Recurrent stroke was responsible for exclusion of 45.4 % of potentially eligible patients . Conclusions — Recurrent stroke represented a big barrier to enroll patients in the protocol . External validity of rehabilitation trials will benefit from definition of study criteria according to regional characteristics of patients , including rates of recurrent stroke . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01333579 Background In the past , clinical study participants have suffered from the experiments that they were subjected to . Study subjects may not underst and the study process or may participate in clinical studies because they do not have access to medical care . The objectives of the present study were 1 . to analyze the motives that might cause a volunteer to participate as a study subject ; 2 . to identify the social-demographic profile of this study subjects ; and 3 . to determine whether the motives to volunteer as a study subject are in accordance with the established legal and ethical principles for research in Brazil . Methods Mixed- methods research was used ( a qualitative-quantitative approach ) . A sample of 80 volunteers underwent a semi-structured interview , which was based on a survey script that was elaborated from discussion s with key informants . The sample was r and omly selected from a data base of clinical study volunteers that was provided by Brazilian clinical study centers . The interviews were recorded and transcribed . Descriptive statistics were used for content analysis , including contingency tables with hypothesis testing . Results The motivations for clinical study participation were linked to types of benefit . The most frequently encountered motivations were financial gain and therapeutic alternative . Altruism was not a common motivator , and when altruism was present , it was observed as a secondary motivator . All participants reported that they understood the Informed Consent Statement ( ICS ) . However , only two parts of the form were remembered by all of the volunteers : the section on being able to leave the study at any point and the section that stated that there would be some responsible professional at their disposal for the entirety of the study . Conclusions The present study shows that study participants are primarily motivated by personal benefit when volunteering to participate in clinical studies . Whether these study participants had an integral underst and ing of the ICS is not clear Background Mexico has the highest adult overweight and obesity prevalence in the Americas ; 23.8 % of children < 5 years old are at risk for overweight and 9.7 % are already overweight or obese . Creciendo Sanos was a pilot intervention to prevent obesity among preschoolers in Instituto Mexicano del Seguro Social ( IMSS ) clinics . Methods We r and omized 4 IMSS primary care clinics to either 6 weekly educational sessions promoting healthful nutrition and physical activity or usual care . We recruited 306 parent-child pairs : 168 intervention , 138 usual care . Children were 2 - 5 years old with WHO body mass index ( BMI ) z-score 0 - 3 . We measured children ’s height and weight and parents reported children ’s diet and physical activity at baseline and 3 and 6-month follow-up . We analyzed behavioral and BMI outcomes with generalized mixed models incorporating multiple imputation for missing values . Results 93 ( 55 % ) intervention and 96 ( 70 % ) usual care families completed 3 and 6-month follow-up . At 3 months , intervention v. usual care children increased vegetables by 6.3 servings/week ( 95 % CI , 1.8 , 10.8 ) . In stratified analyses , intervention participants with high program adherence ( 5 - 6 sessions ) decreased snacks and screen time and increased vegetables v. usual care . No further effects on behavioral outcomes or BMI were observed . Transportation time and expenses were barriers to adherence . 90 % of parents who completed the post-intervention survey were satisfied with the program . Conclusions Although satisfaction was high among participants , barriers to participation and retention included transportation cost and time . In intention to treat analyses , we found intervention effects on vegetable intake , but not other behaviors or BMI .Trial registration Clinical Trials.gov NCT01539070.Comisión Nacional de Investigación Científica del IMSS : 2009 - 785 - 120 The study objective was to assess willingness of men who have sex with men ( MSM ) enrollled in a vaccine preparedness study ( ' Projeto Rio ' ) to participate in phase III anti-HIV/AIDS vaccine trials . Overall , 57 % of Projeto Rio participants stated they would participate in a putative vaccine trial . MSM who reported commercial sex work were significantly ( p<0.05 ) more likely to engage in risky behaviours than others . In bivariate analysis , commercial sex workers ( CSWs ) were significantly ( p<0.05 ) more likely than non-commercial sex workers ( NCSWs ) to be willing to participate in vaccine trials ( 62.6 % versus 51.4 % ) . Among those willing , CSWs reported significantly more often ( p<0.05 ) ( 50.5 % ) than NCSWs ( 38.0 % ) that they would enroll to protect themselves from HIV . In multivariate analyses , variables associated with willingness to participate ( WTP ) were lower educational level , positive serology for syphilis , and ' engagement , under the influence of alcohol , in risky sexual practice s that would normally be avoided ' , but not commercial sex work . The potential enrollment in vaccine trials of MSM CWSs , as well as participants of low socio-economic status and high risk , seems thus to be possible Background During the last decade , the number of clinical trials conducted in sub-Saharan Africa has increased significantly which has helped to address priority health problems in the region . Navrongo health research centre since it was established in 1989 , has conducted several trial studies including rectal artesunate trial in the Kassena-Nankana districts . However , there is little evidence -based for assessing the impact of new drug trials . This study explored factors that motivate parents to allow their children to participate in new drug trials in northern Ghana . Method The study used both quantitative and qualitative methods . The participants were r and omly selected from among parents whose children were enrolled in a new drug trial conducted in the Kassena-Nankana districts between 2000 and 2003 . QSR Nvivo 9 software was used to code the qualitative data into themes before analysis while STATA software Version 11.2 © was used to analyze the quantitative data . Results The results showed that majority ( 95.9 % ) of the parents were willing to allow their children to be enrolled in future new drug trials . The main factors motivating their willingness to allow their children to be enrolled in these trials were quality of health care services offered to trial participants ( 92.9 % ) , detail medical examination ( 90.8 % ) , promptness of care provided ( 94.4 % ) and quality of drugs ( 91.9 % ) . Other factors mentioned included disease prevention ( 99.5 % )
Output:
| Altruism , personal health benefits , access to health care , monetary benefit , knowledge , social support and trust were the most important reasons for participation .
Primary reasons for non‐participation were safety concerns , inconvenience , stigmatisation , lack of social support , confidentiality concerns , physical pain , efficacy concerns and distrust .
Stigmatisation was a major concern in relation to HIV research .
Reasons were similar across different regions , gender , non‐patient or patient participants and real or hypothetical study design s. Conclusions Addressing factors that affect (non‐)participation in the planning process and during the conduct of research may enhance voluntary consent to participation and reduce barriers for potential participants |
MS211816 | ***TASK*** the task is to summarize an input biomedical literature 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 Green tea consumption has been associated with favorable changes in body weight and obesity-related hormones , although it is not known whether these changes result from green tea polyphenols or caffeine . OBJECTIVE We examined the impact of decaffeinated green tea extract ( GTE ) containing 843 mg of (-)-epigallocatechin-3-gallate on anthropometric variables , obesity-associated hormones , and glucose homeostasis . METHODS The Minnesota Green Tea Trial was a 12-mo r and omized , double-blind , placebo-controlled clinical trial of 937 healthy postmenopausal women assigned to either decaffeinated GTE ( 1315 mg total catechins/d ) or a placebo , stratified by catechol-O-methyltransferase ( COMT ) genotype . This study was conducted in a subset of 237 overweight and obese participants [ body mass index ( BMI ) ≥25 kg/m(2 ) ] . RESULTS No changes in energy intake , body weight , BMI , or waist circumference ( WC ) were observed over 12 mo in women taking GTE ( n = 117 ) or placebo ( n = 120 ) . No differences were seen in circulating leptin , ghrelin , adiponectin , or glucose concentrations at month 12 . Participants r and omly assigned to GTE with baseline insulin ≥10 μIU/mL ( n = 23 ) had a decrease in fasting serum insulin from baseline to month 12 ( -1.43 ± 0.59 μIU/mL ) , whereas those r and omly assigned to placebo with baseline insulin ≥10 μIU/mL ( n = 19 ) had an increase in insulin over 12 mo ( 0.55 ± 0.64 μIU/mL , P < 0.01 ) . Participants with the homozygous high-activity ( G/G ) form of COMT had significantly lower adiponectin ( 5.97 ± 0.50 compared with 7.58 ± 0.53 μg/mL , P = 0.03 ) and greater insulin concentrations ( 7.63 ± 0.53 compared with 6.18 ± 0.36 μIU/mL , P = 0.02 ) at month 12 compared with those with the low-activity ( A/A ) genotype , regardless of treatment group . CONCLUSIONS Decaffeinated GTE was not associated with reductions in body weight , BMI , or WC and did not alter energy intake or mean hormone concentrations in healthy postmenopausal women over 12 mo . GTE decreased fasting insulin concentrations in those with elevated baseline fasting concentrations . The high-activity form of the COMT enzyme may be associated with elevations in insulin and a reduction in adiponectin concentrations over time . This trial was registered at http://www . clinical trials.gov as NCT00917735 Background —Epidemiological studies suggest that tea consumption decreases cardiovascular risk , but the mechanisms of benefit remain undefined . Endothelial dysfunction has been associated with coronary artery disease and increased oxidative stress . Some antioxidants have been shown to reverse endothelial dysfunction , and tea contains antioxidant flavonoids . Methods and Results —To test the hypothesis that tea consumption will reverse endothelial dysfunction , we r and omized 66 patients with proven coronary artery disease to consume black tea and water in a crossover design . Short-term effects were examined 2 hours after consumption of 450 mL tea or water . Long-term effects were examined after consumption of 900 mL tea or water daily for 4 weeks . Vasomotor function of the brachial artery was examined at baseline and after each intervention with vascular ultrasound . Fifty patients completed the protocol and had technically suitable ultrasound measurements . Both short- and long-term tea consumption improved endothelium- dependent flow-mediated dilation of the brachial artery , whereas consumption of water had no effect ( P < 0.001 by repeated- measures ANOVA ) . Tea consumption had no effect on endothelium-independent nitroglycerin-induced dilation . An equivalent oral dose of caffeine ( 200 mg ) had no short-term effect on flow-mediated dilation . Plasma flavonoids increased after short- and long-term tea consumption . Conclusions —Short- and long-term black tea consumption reverses endothelial vasomotor dysfunction in patients with coronary artery disease . This finding may partly explain the association between tea intake and decreased cardiovascular disease events BACKGROUND Green tea is one of the most popular beverages in the world . It is believed to have beneficial effects in the prevention and treatment of many diseases , one of which is type 2 diabetes . The aim of the study is to examine the effect of a decaffeinated green tea extract ( GTE ) providing a daily dose of 856 mg of epigallocatechin gallate ( EGCG ) on obese individuals with type 2 diabetes . MATERIAL S AND METHODS The clinical trial was a r and omized , double-blind , placebo-controlled clinical trial conducted from December 2007 through November 2008 . The subjects were r and omly assigned to either receive 1,500 mg of a decaffeinated GTE or placebo daily for 16 weeks . Sixty-eight of 80 subjects , ages 20 - 65 years with BMI > 25 kg/m2 and type 2 diabetes for more than one year , completed this study . Homeostasis model assessment for insulin resistance ( HOMA-IR ) was used as the major outcome measurement . At baseline and after 16 weeks of treatment , anthropometric measurements , fasting glucose , hemoglobin A1C percent ( HbA1C ) , hormone peptides , and plasma lipoproteins were measured from both groups . RESULTS No statistically significant differences were detected between the decaffeinated GTE and placebo groups in any measured variable . A statistically significant within-group 0.4-percent reduction in HbA1C ( from 8.4 to 8.0 % ) was observed after GTE treatment compared to baseline . Within-group comparison also revealed that the GTE group had significant reductions in waist circumference ( WC ) , HOMA-IR index , and insulin level , and a significant increase in the level of ghrelin . Within-group comparison of those in the placebo group showed a significant increase in the level of ghrelin . CONCLUSIONS This study found no statistical difference in any measured variable between the decaffeinated GTE and placebo groups ; however , there were some statistically significant within-group changes detected . More research is required to determine whether a decaffeinated GTE st and ardized for EGCG content will provide any clinical benefits in obese individuals with type 2 diabetes . Clinical Trial Registration NO : NCT00567905 AIMS Coffee consumption is associated with a reduced risk of Type 2 diabetes . Our aim was to investigate if coffee intake may also reduce the risk of latent autoimmune diabetes in adults , an autoimmune form of diabetes with features of Type 2 diabetes . METHODS We used data from a population -based case-control study with incident cases of adult onset ( ≥ 35 years ) diabetes , including 245 cases of latent autoimmune diabetes in adults ( glutamic acid decarboxylase antibody positive ) , 759 cases of Type 2 diabetes ( glutamic acid decarboxylase antibody negative ) , together with 990 control subjects without diabetes , r and omly selected from the population . Using question naire information on coffee consumption , we estimated the odds ratio of latent autoimmune diabetes in adults and Type 2 diabetes adjusted for age , sex , BMI , smoking , physical activity , alcohol , education and family history of diabetes . RESULTS Coffee intake was inversely associated with Type 2 diabetes ( odds ratio 0.92 , 95 % CI 0.87 - 0.98 per cup/day ) . With regard to latent autoimmune diabetes in adults , the general trend was weak ( odds ratio 1.04 , 95 % CI 0.96 - 1.13 ) , but stratification by degree of autoimmunity ( median glutamic acid decarboxylase antibody levels ) suggested that coffee intake may be associated with an increased risk of high glutamic acid decarboxylase antibody latent autoimmune diabetes in adults ( odds ratio 1.11 , 95 % CI 1.00 - 1.23 per cup/day ) . Furthermore , for every additional cup of coffee consumed per day , there was a 15.2 % ( P = 0.0268 ) increase in glutamic acid decarboxylase antibody levels . CONCLUSIONS Our findings confirm that coffee consumption is associated with a reduced risk of Type 2 diabetes . Interestingly , the findings suggest that coffee may be associated with development of autoimmunity and possibly an increased risk of more Type 1-like latent autoimmune diabetes in adults Purpose Coffee is known to contain phytochemicals with antioxidant potential . The aim of this study was to investigate possible antioxidant effects of coffee in healthy human volunteers . Methods A placebo-controlled intervention trial was carried out on 160 healthy human subjects , r and omised into three groups , receiving 3 or 5 cups of study coffee or water per day , for 8 weeks . Blood sample s were taken before , during , and after the intervention . Serum was used for analysis of blood lipids and st and ard clinical chemistry analytes . Peripheral blood mononuclear cells were isolated , and DNA damage ( str and breaks and oxidised bases ) was measured with the comet assay . The lipid oxidation product isoprostane 8-iso-PGF2α was assayed in urine sample s by LC – MS/MS . Results There was no significant effect of coffee consumption on the markers of oxidation of DNA and lipids . Creatinine ( in serum ) increased by a few per cent in all groups , and the liver enzyme γ-glutamyl transaminase was significantly elevated in serum in the 5 cups/day group . Other clinical markers ( including glucose and insulin ) , cholesterol , triacylglycerides , and inflammatory markers were unchanged . There was no effect of coffee on blood pressure . Conclusion In a carefully controlled clinical trial with healthy subjects , up to 5 cups of coffee per day had no detectable effect , either beneficial or harmful , on human health BACKGROUND Increasing coffee intake was inversely associated with risk of type 2 diabetes in population s of European descent ; however , data from high-risk Asian population s are lacking as are data on tea intake in general . OBJECTIVE We investigated the prospect i ve associations between intakes of coffee , black tea , and green tea with the risk of type 2 diabetes in Singaporean Chinese men and women . DESIGN We analyzed data from 36 908 female and male participants in the Singapore Chinese Health Study aged 45 - 74 y in 1993 - 1998 who had multiple diet and lifestyle measures assessed and then were followed up between 1999 and 2004 . We used Cox regression models to investigate the association of baseline coffee and tea intakes with incident type 2 diabetes during follow-up , with adjustment for a number of possible confounding or mediating variables . RESULTS In multivariate models participants reporting > or = 4 cups of coffee/d had a 30 % reduction in risk of diabetes [ relative risk ( RR ) : 0.70 ; 95 % CI : 0.53 , 0.93 ] compared with participants who reported nondaily consumption . Participants reporting > or = 1 cup of black tea/d had a suggestive 14 % reduction in risk of diabetes ( RR : 0.86 ; 95 % CI : 0.74 , 1.00 ) compared with participants who reported 0 cups/d , and we observed no association with green tea . CONCLUSION Regular consumption of coffee and potentially black tea , but not green tea , is associated with lower risk of type 2 diabetes in Asian men and women in Singapore The aim of this study is to investigate the effect of green tea extract on patients with type 2 diabetes mellitus and lipid abnormalities on glycemic and lipid profiles , and hormone peptides by a double-blinded , r and omized and placebo-controlled clinical trial . This trial enrolled 92 subjects with type 2 diabetes mellitus and lipid abnormalities r and omized into 2 arms , each arm comprising 46 participants . Of the participants , 39 in therapeutic arm took 500 mg green tea extract , three times a day , while 38 in control arm took cellulose with the same dose and frequency to complete the 16-week study . Anthropometrics measurements , glycemic and lipid profiles , safety parameters , and obesity-related hormone peptides were analyzed at screening and after 16-week course . Within-group comparisons showed that green tea extract caused a significant decrease in triglyceride and homeostasis model assessment of insulin resistance index after 16 weeks . Green tea extract also increased significantly high density lipoprotein cholesterol . The HOMA-IR index decreased from 5.4±3.9 to 3.5±2.0 in therapeutic arm only . Adiponectin , apolipoprotein A1 , and apolipoprotein B100 increased significantly in both arms , but only glucagon-like peptide 1 increased in the therapeutic arm
Output:
| The oolong tea group also showed a significant decrease in FBG , but the quality of evidence was very low .
In conclusion , green tea consumption might decrease FBG levels , especially in < 55-year-olds or Asian-based population |
MS211817 | ***TASK*** the task is to summarize an input biomedical literature 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 In a double blind , placebo controlled trial of 40 volunteers , the burning discomfort associated with application of capsaicin cream ( 0.025 % ) was compared to placebo , GTN cream ( 1.33 % ) and to the combination of capsaicin cream ( 0.025 % ) plus GTN cream 1.33 % . Median VAS for burning pain were 0 for the placebo , GTN and GTN+capsaicin groups and 3 for the capsaicin group after single application of each cream at daily intervals . This study demonstrates that after single application the addition of GTN to capsaicin significantly reduces the burning discomfort associated with application of capsaicin alone Experimental studies have indicated that N-methyl-D-aspartate ( NMDA ) receptor antagonists may be effective analgesics in a wide variety of chronic pain states . The mechanism is presumed to be related to decreased firing of dorsal horn neurons after constant repeated C-fiber stimulation . Dextromethorphan ( DM ) , a potent NMDA antagonist with a good safety profile , may be a promising agent for the treatment of persistent pain . An open-label r and omized trial was design ed to examine the effects of combining DM with NSAIDs , dextropropoxyphene , or morphine in cancer patients with pain . Patients who required a change in the step of the World Health Organization 's ( WHO ) analgesic ladder because of a pain level of 4 or more on a numerical pain scale were r and omly allocated to receive DM 30 mg three times a day ( 30 patients ) or conventional treatment ( 30 patients ) . There were 20 patients r and omized for each step of the analgesic ladder . Pain mechanisms , pain intensity ( numerical 0 - 10 scale ) , symptoms more frequently present in advanced cancer patients or associated with opioid therapy ( grade d on a 0 - 3 scale -- not at all , slight , a lot , awful ) , opioid escalation index , days on opioid treatment , and adverse effects were recorded . After 2 days 75 % , 80 % , and 100 % of patients treated with DM in steps 1 , 2 , and 3 , respectively , required conventional treatment , because adequate pain relief had not been achieved ( pain scale > 4 ) . Failure of this treatment was equally observed in neuropathic pain or nociceptive pain syndromes . Four patients treated with DM who did not require the conventional treatment immediately did require this change after some days , due to poor pain control . A highly significant reduction in pain was observed in patients directly treated with the conventional treatment in all the three steps of the analgesic ladder . No significant analgesic effects could be found when DM at this dose was combined with NSAIDs , dextropropoxyphene , or morphine Aims and Background Amitriptyline is the most common analgesic adjuvant used in cancer patients with neuropathic pain , even though no specific studies have demonstrated a benefit . A r and omized placebo-controlled , double-blind crossover study was design ed to evidence the effects of amitriptyline in patients with neuropathic cancer pain . Methods Sixteen advanced cancer patients with neuropathic pain on systemic morphine therapy , no longer receiving oncologic treatment , presenting moderate pain ( about 4 or more , but less than 7 , on a numerical scale of 0 - 10 ) in the last week , and given a stable morphine dose in the last 2 days were admitted to the study . During the first week of study , patients were administered 25 mg of amitriptyline or equivalent drops of placebo at night for 3 days and 50 mg for the following 4 days . Doses for patients aged more than 65 years were 15 mg ( first 3 days ) and 30 mg ( 3 days after ) . After a week , a crossover took place for the second week , with the other treatment at an inverse sequence . Opioid consumption , pain intensity , symptoms and adverse effects , mood , sleep , patient 's preference , quality of life before starting the study , the first week after and the second week after were recorded . Results No significant benefits in analgesia were found in the global pain intensity of the previous week of treatment , the least pain intensity or the pain evaluated just after a week of treatment , at the moment of the visit , when amitriptyline was compared with placebo . A significant difference was evidence d for the worst pain ( P < 0.035 ) . No differences in opioid doses during the period of study were found . Drowsiness , confusion and dry mouth were significantly more intense with amitriptyline than with placebo ( P < 0.036 , 0.003 , and 0.034 , respectively ) . There were no substantial differences between the two treatments in Spitzer 's quality of life score and for each item . No differences in patients ' preference for the two treatment periods were found . The analgesic effects of amitriptyline were slight and associated with adverse effects . Conclusions In light of the results obtained in the study , the extensive use of the drug for cancer pain should be question ed Neuropathic cancer pain represents a major challenge . Treatment often requires adjuvant analgesics , including gabapentin , to complement the effects of opioids . This study aim ed to compare the effectiveness and safety of gabapentin combined with an opioid versus opioid monotherapy for the management of neuropathic cancer pain . Seventy-five cancer patients who were receiving opioid therapy and reported sufficient pain relief of nociceptive , but not neuropathic , pain were enrolled . Sixty-three patients completed the study . Patients were r and omized to one of the following treatment protocol s : 1 ) gabapentin adjuvant to ongoing opioid treatment titrated according to pain response while opioid dose was kept constant ( group GO ) , and 2 ) continuation of opioid monotherapy according to the World Health Organization treatment ladder approach ( group OO ) . Changes in pain intensity , allodynia , and analgesic drug consumption were evaluated at Day 4 and Day 13 . Side effects were also recorded . Both treatments result ed in a significant reduction of pain intensity at Day 4 and Day 13 compared to baseline . However , mean pain intensity for burning and shooting pain was significantly higher in the OO group compared to the GO group at both the fourth ( P=0.0001 ) and 13th ( P=0.0001 ) days of the study . An earlier significant decrease ( at Day 4 , P=0.002 ) was observed for allodynia in the GO group compared to the OO group . The rate of side effects in the GO group was significantly lower than that in the OO group ( P=0.015 ) . These data suggest that gabapentin added to an opioid provides better relief of neuropathic pain in cancer patients than opioid monotherapy ; this combination of gabapentin and an opioid may represent a potential first-line regimen for the management of pain in these patients & NA ; Topical aspirin/diethyl ether ( ADE ) mixture was used to treat 45 consecutive patients with acute herpetic neuralgia ( AHN ) ( n = 28 ) and with post‐herpetic neuralgia ( PHN ) ( n = 17 ) in an open‐label study . Good‐to‐excellent results were achieved by 93 % of AHN patients and by 65 % of PHN patients . Earlier treatment yielded better results for the AHN but not the PHN group . The topical treatment seemed to accelerate the healing of acute herpetic skin lesions and possibly modulate the severity of the herpetic infection . Furthermore , a striking reduction in the percentage of AHN patients developing PHN was observed in the treated group , as compared with the disease natural history reported in the literature ( 4 vs. 50–70 % ) . Treatment tolerance was excellent with no adverse effect observed . In addition to the open trial , a pilot double‐blind crossover placebo‐controlled study ( n = 11 ) compared the analgesic efficacy of ADE with two other NSAID ( indomethacin and diclofenac ) drug/ether mixtures . Aspirin ( but not indomethacin and diclofenac ) was significantly superior to placebo as regards pain relief ( P < 0.05 ) 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 Background We have recently reported successful treatment of patients with chronic pain syndromes using human pooled intravenous immunoglobulin ( IVIG ) in a prospect i ve , open-label cohort study . A r and omised , placebo controlled , double blinded study is needed to confirm these results . We chose to study patients with carbamazepine resistant primary Trigeminal Neuralgia ( rpTN ) , as these had responded particularly well to IVIG.A protocol involving the use of IVIG in rpTN is complex for three reasons : 1 . The effect of IVIG does not follow simple dose-response rules ; 2 . The response pattern of patients to IVIG was variable and ranged between no effect at all and pain free remission between two weeks and > 1 year ; 3 . TN is characterized by extremely severe pain , for which operative intervention is ( if temporarily ) helpful in most patients . Design A placebo controlled , parallel , add-on model was developed and the primary outcome variable defined as the length of time during which patients remain in the study . Study groups are compared using Kaplan-Maier survival analysis . Patients record their response to treatment ( " severe , moderate , slight , no pain " ) . The study coordinator monitors pain diaries . Severe or moderate pain of three days duration will result in termination of the study for that patient . Conclusions This study design utilizes a method of survival analysis and is novel in chronic pain research . It allows for both early departure from the study and voluntary crossover upon non-response . It may be applicable to the analysis of IVIG efficacy in other chronic pain syndromes & NA ; Levodopa has been used to treat some painful conditions and found to be effective in neuropathic pain due to herpes zoster in a double‐blind study . From our anecdotal observations about the efficacy of levodopa on diabetic neuropathic pain , we design ed a double‐blind placebo‐controlled study to test levodopa in painful diabetic neuropathy . Twenty‐five out‐ patients with painful symmetrical diabetic polyneuropathy were admitted to the study . Fourteen patients were given 100 mg levodopa plus 25 mg benserazide to be taken three times per day for 28 days . Eleven patients were given identical placebo capsules . A blinded neurologist evaluated the patients clinical ly and performed Visual Analogue Scale ( VAS ) measurement every week from day 0 to day 28 . The results seemed promising and levodopa may be a choice for the control of pain in neuropathy for which we do not have many alternative treatments This observational study examined the outcome of two different therapeutic strategies in the treatment of chronic neuropathic pain by including pregabalin ( PGB ) as mono- or add-on therapy in one of two treatment options . Patients with a pain score of ≥4 , refractory to usual care for neuropathic pain for at least 6 months , were allocated consecutively to one of two treatment strategies according to the decision of the physician : complete switch to a flexible-dosage , monotherapeutic or add-on therapy with pregabalin ( PGB group ) , or change established doses and combinations of pre-existing mono- or combination therapy without pregabalin ( non-PGB group ) . After 4 weeks ( primary endpoint ) a significant improvement in pain reduction was documented in both intention-to treat ( ITT ) analysis ( PGB group , n = 85 : mean pain score reduction of 3.53 , SD 2.03 , p < 0.001 ; non-PGB group , n = 102 ; mean pain score reduction of 2.83 , SD 2.23 , p < 0.001 ) and per- protocol ( PP ) analysis ( PGB group , n = 79 : mean pain score reduction 3.53 vs. 2.83 , p < 0.05 ; non-PGB group , n = 81 ; 3.5 vs. 2.9 , p < 0.05 ) compared to baseline . Comparison of the
Output:
| However , this combination also produced significantly more frequent side effect-related trial dropouts compared to gabapentin alone .
AUTHORS ' CONCLUSIONS Multiple , good- quality studies demonstrate superior efficacy of two-drug combinations .
However , the number of available studies for any one specific combination , as well as other study factors ( e.g. limited trial size and duration ) , preclude the recommendation of any one specific drug combination for neuropathic pain . |
MS211818 | ***TASK*** the task is to summarize an input biomedical literature 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 Chemohormonal therapy with docetaxel and and rogen deprivation therapy ( ADT+D ) for metastatic hormone-sensitive prostate cancer improves overall survival as compared with and rogen deprivation therapy ( ADT ) alone . We compared the quality of life ( QOL ) between patients with metastatic hormone-sensitive prostate cancer who were treated with ADT+D and those who were treated with ADT alone . Methods Men were r and omly assigned to ADT+ D ( six cycles ) or to ADT alone . QOL was assessed by Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) , FACT-Taxane , Functional Assessment of Chronic Illness Therapy-Fatigue , and the Brief Pain Inventory at baseline and at 3 , 6 , 9 , and 12 months . The Wilcoxon signed rank test was used to examine changes over time . Mixed-effect models compared the QOL between arms at each time point . Results Seven hundred ninety men were r and omly assigned ( ADT+D [ n = 397 ] and ADT [ n = 393 ] ) and completed FACT-P ( 90 % at baseline , 86 % at 3 months , 83 % at 6 months , 78 % at 9 months , and 77 % at 12 months ) . ADT+D patients reported a statistically significant decline in FACT-P at 3 months ( P < .001 ) but FACT-P did not differ significantly between baseline and 12 months ( P = .38 ) . ADT+D FACT-P scores were significantly lower at 3 months ( P = .02 ) but significantly higher at 12 months ( P = .04 ) when compared with ADT FACT-P scores . Differences did not exceed the minimal clinical ly important difference at any time point . ADT+D patients reported significantly lower Functional Assessment of Chronic Illness Therapy-Fatigue scores at 3 months than did ADT patients ( P < .001 ) . Over time , both arms reported significantly poorer FACT-Taxane scores ( P < .001 ) when compared with baseline . Brief Pain Inventory scores were similar between arms . Conclusion Although ADT+D was associated with statistically worse QOL at 3 months , QOL was better at 12 months for ADT+D patients than for ADT patients . Both arms reported a similar minimally changed QOL over time , suggesting that ADT+D is not associated with a greater long-term negative impact on QOL 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 Summary Background Long-term hormone therapy has been the st and ard of care for advanced prostate cancer since the 1940s . STAMPEDE is a r and omised controlled trial using a multiarm , multistage platform design . It recruits men with high-risk , locally advanced , metastatic or recurrent prostate cancer who are starting first-line long-term hormone therapy . We report primary survival results for three research comparisons testing the addition of zoledronic acid , docetaxel , or their combination to st and ard of care versus st and ard of care alone . Methods St and ard of care was hormone therapy for at least 2 years ; radiotherapy was encouraged for men with N0M0 disease to November , 2011 , then m and ated ; radiotherapy was optional for men with node-positive non-metastatic ( N+M0 ) disease . Stratified r and omisation ( via minimisation ) allocated men 2:1:1:1 to st and ard of care only ( SOC-only ; control ) , st and ard of care plus zoledronic acid ( SOC + ZA ) , st and ard of care plus docetaxel ( SOC + Doc ) , or st and ard of care with both zoledronic acid and docetaxel ( SOC + ZA + Doc ) . Zoledronic acid ( 4 mg ) was given for six 3-weekly cycles , then 4-weekly until 2 years , and docetaxel ( 75 mg/m2 ) for six 3-weekly cycles with prednisolone 10 mg daily . There was no blinding to treatment allocation . The primary outcome measure was overall survival . Pairwise comparisons of research versus control had 90 % power at 2·5 % one-sided α for hazard ratio ( HR ) 0·75 , requiring roughly 400 control arm deaths . Statistical analyses were undertaken with st and ard log-rank-type methods for time-to-event data , with hazard ratios ( HRs ) and 95 % CIs derived from adjusted Cox models . This trial is registered at Clinical Trials.gov ( NCT00268476 ) and ControlledTrials.com ( IS RCT N78818544 ) . Findings 2962 men were r and omly assigned to four groups between Oct 5 , 2005 , and March 31 , 2013 . Median age was 65 years ( IQR 60–71 ) . 1817 ( 61 % ) men had M+ disease , 448 ( 15 % ) had N+/X M0 , and 697 ( 24 % ) had N0M0 . 165 ( 6 % ) men were previously treated with local therapy , and median prostate-specific antigen was 65 ng/mL ( IQR 23–184 ) . Median follow-up was 43 months ( IQR 30–60 ) . There were 415 deaths in the control group ( 347 [ 84 % ] prostate cancer ) . Median overall survival was 71 months ( IQR 32 to not reached ) for SOC-only , not reached ( 32 to not reached ) for SOC + ZA ( HR 0·94 , 95 % CI 0·79–1·11 ; p=0·450 ) , 81 months ( 41 to not reached ) for SOC + Doc ( 0·78 , 0·66–0·93 ; p=0·006 ) , and 76 months ( 39 to not reached ) for SOC + ZA + Doc ( 0·82 , 0·69–0·97 ; p=0·022 ) . There was no evidence of heterogeneity in treatment effect ( for any of the treatments ) across prespecified subsets . Grade 3–5 adverse events were reported for 399 ( 32 % ) patients receiving SOC , 197 ( 32 % ) receiving SOC + ZA , 288 ( 52 % ) receiving SOC + Doc , and 269 ( 52 % ) receiving SOC + ZA + Doc . Interpretation Zoledronic acid showed no evidence of survival improvement and should not be part of st and ard of care for this population . Docetaxel chemotherapy , given at the time of long-term hormone therapy initiation , showed evidence of improved survival accompanied by an increase in adverse events . Docetaxel treatment should become part of st and ard of care for adequately fit men commencing long-term hormone therapy . Funding Cancer Research UK , Medical Research Council , Novartis , Sanofi-Aventis , Pfizer , Janssen , Astellas , NIHR Clinical Research Network , Swiss Group for Clinical Cancer Research Background Abiraterone acetate plus prednisolone improves survival in men with relapsed prostate cancer . We assessed the effect of this combination in men starting long‐term and rogen‐deprivation therapy ( ADT ) , using a multigroup , multistage trial design . Methods We r and omly assigned patients in a 1:1 ratio to receive ADT alone or ADT plus abiraterone acetate ( 1000 mg daily ) and prednisolone ( 5 mg daily ) ( combination therapy ) . Local radiotherapy was m and ated for patients with node‐negative , nonmetastatic disease and encouraged for those with positive nodes . For patients with nonmetastatic disease with no radiotherapy planned and for patients with metastatic disease , treatment continued until radiologic , clinical , or prostate‐specific antigen ( PSA ) progression ; otherwise , treatment was to continue for 2 years or until any type of progression , whichever came first . The primary outcome measure was overall survival . The intermediate primary outcome was failure‐free survival ( treatment failure was defined as radiologic , clinical , or PSA progression or death from prostate cancer ) . Results A total of 1917 patients underwent r and omization from November 2011 through January 2014 . The median age was 67 years , and the median PSA level was 53 ng per milliliter . A total of 52 % of the patients had metastatic disease , 20 % had node‐positive or node‐indeterminate nonmetastatic disease , and 28 % had node‐negative , nonmetastatic disease ; 95 % had newly diagnosed disease . The median follow‐up was 40 months . There were 184 deaths in the combination group as compared with 262 in the ADT‐alone group ( hazard ratio , 0.63 ; 95 % confidence interval [ CI ] , 0.52 to 0.76 ; P<0.001 ) ; the hazard ratio was 0.75 in patients with nonmetastatic disease and 0.61 in those with metastatic disease . There were 248 treatment‐failure events in the combination group as compared with 535 in the ADT‐alone group ( hazard ratio , 0.29 ; 95 % CI , 0.25 to 0.34 ; P<0.001 ) ; the hazard ratio was 0.21 in patients with nonmetastatic disease and 0.31 in those with metastatic disease . Grade 3 to 5 adverse events occurred in 47 % of the patients in the combination group ( with nine grade 5 events ) and in 33 % of the patients in the ADT‐alone group ( with three grade 5 events ) . Conclusions Among men with locally advanced or metastatic prostate cancer , ADT plus abiraterone and prednisolone was associated with significantly higher rates of overall and failure‐free survival than ADT alone . ( Funded by Cancer Research U.K. and others ; STAMPEDE Clinical Trials.gov number , NCT00268476 , and Current Controlled Trials number , IS RCT N78818544 .
Output:
| Enzalutamide appeared to have better OS compared with docetaxel in men with low-volume disease , but there was no difference in other comparisons .
Combination therapy with any of docetaxel , abiraterone acetate , enzalutamide , or apalutamide provides a significant OS benefit when compared with ADT alone .
We did not identify significant differences in OS between different combination therapies . |
MS211819 | ***TASK*** the task is to summarize an input biomedical literature 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 — Data supporting the prognostic significance of high-sensitivity C-reactive protein ( hs-CRP ) are derived largely from individuals with no overt coronary artery disease or from patients with acute coronary syndromes . In contrast , the ability of hs-CRP to predict outcomes in patients with stable coronary artery disease and the prognostic significance of the Centers for Disease Control/American Heart Association hs-CRP cut points in such a population remain relatively unexplored . Methods and Results — We measured hs-CRP in 3771 patients with stable coronary artery disease from the Prevention of Events With Angiotensin-Converting Enzyme Inhibition ( PEACE ) trial , a r and omized placebo-controlled trial of the angiotensin-converting enzyme inhibitor tr and olapril . Patients were followed up for a median of 4.8 years for cardiovascular death , myocardial infa rct ion , or stroke , as well as new heart failure and diabetes . After adjustment for baseline characteristics and treatments , higher hs-CRP levels , even > 1 mg/L , were associated with a significantly greater risk of cardiovascular death , myocardial infa rct ion , or stroke ( hs-CRP 1 to 3 mg/L : adjusted hazard ratio , 1.39 ; 95 % CI , 1.06 to 1.81 ; P=0.016 ; hs-CRP > 3 mg/L : adjusted hazard ratio , 1.52 ; 95 % CI , 1.15 to 2.02 ; P=0.003 ) . Similarly , elevated hs-CRP levels were an independent predictor of new heart failure ( adjusted P<0.001 for trend ) and new diabetes ( adjusted P<0.001 for trend ) . There were no significant interactions between hs-CRP levels and the effects of tr and olapril on any of the above outcomes . Conclusions — In stable coronary artery disease , an elevated hs-CRP level , even > 1 mg/L , is a significant predictor of adverse cardiovascular events independently of baseline characteristics and treatments . An elevated hs-CRP does not appear to identify patients with stable coronary artery disease and preserved ejection fraction who derive particular benefit from angiotensin-converting enzyme inhibition BACKGROUND C-reactive protein ( CRP ) is a sensitive marker of inflammation , and elevated levels have been associated with future risk of myocardial infa rct ion ( MI ) . However , whether measurement of CRP adds to the predictive value of total cholesterol ( TC ) and HDL cholesterol ( HDL-C ) in determining risk is uncertain . METHODS AND RESULTS Among 14916 apparently healthy men participating in the Physicians ' Health Study , baseline levels of CRP , TC , and HDL-C were measured among 245 study subjects who subsequently developed a first MI ( cases ) and among 372 subjects who remained free of cardiovascular disease during an average follow-up period of 9 years ( controls ) . In univariate analyses , high baseline levels of CRP , TC , and TC : HDL-C ratio were each associated with significantly increased risks of future MI ( all P values < 0.001 ) . In multivariate analyses , models incorporating CRP and lipid parameters provided a significantly better method to predict risk than did models using lipids alone ( all likelihood ratio test P values < 0.003 ) . For example , relative risks of future MI among those with high levels of both CRP and TC ( RR=5.0 , P=0.0001 ) were greater than the product of the individual risks associated with isolated elevations of either CRP ( RR=1.5 ) or TC ( RR=2.3 ) . In stratified analyses , baseline CRP level was predictive of risk for those with low as well as high levels of TC and the TC : HDL-C ratio . These findings were virtually identical in analyses limited to nonsmokers and after control for other cardiovascular risk factors . CONCLUSIONS In prospect i ve data from a large cohort of apparently healthy men , baseline CRP level added to the predictive value of lipid parameters in determining risk of first MI Background Pentraxin 3 ( PTX3 ) is a novel inflammatory marker produced by various cell types including those of the vasculature and the heart . The relationship between inflammatory markers and prognosis of patients with heart failure with normal ejection fraction ( HFNEF ) remains unknown . We investigated whether plasma PTX3 levels can predict future cardiovascular events in patients with HFNEF . Methods and Results Plasma PTX3 , high‐sensitivity C‐reactive protein , and B‐type natriuretic peptide levels were measured prospect ively in 360 stable patients with HFNEF . The subsequent incidence of cardiovascular events , including cardiovascular death , nonfatal myocardial infa rct ion ( MI ) , unstable angina pectoris , nonfatal ischemic stroke , hospitalization for heart failure decompensation , and coronary revascularization , was determined . During a mean 30‐month follow‐up , 106 patients experienced cardiovascular events . These events were more frequent in patients with high plasma PTX3 levels ( > 3.0 ng/mL ) than low levels ( ≤3.0 ng/mL ) . Multivariable Cox hazard analysis showed that PTX3 ( hazard ratio : 1.16 ; 95 % CI : 1.05 to 1.27 ; P<0.01 ) and B‐type natriuretic peptide ( hazard ratio : 1.08 ; 95 % CI : 1.03 to 1.14 ; P<0.001 ) , but not high‐sensitivity C‐reactive protein levels , were significant predictors of future cardiovascular events . Multivariable Cox analysis with the forced inclusion model , including 5 previously identified prognostic factors , found that PTX3 was a significant predictor of cardiovascular events ( hazard ratio : 1.16 ; 95 % CI : 1.06 to 1.27 ; P<0.01 ) . The C‐statistics for cardiovascular events substantially increased from 0.617 to 0.683 when PTX3 was added to the 5 previously identified prognostic factors . Conclusions High plasma PTX3 levels , but not other inflammatory markers , are correlated with future cardiovascular events in patients with HFNEF . PTX3 may be a useful biomarker for assessment of risk stratification in HFNEF . Clinical Trial Registration URL : http://www.umin.ac.jp ; Unique identifier : UMIN000002170 Sensitive cardiac troponin I ( cTnI ) predicts all-cause and cardiovascular mortality in various clinical setting s. However , its clinical significance in hemodialysis ( HD ) patients with preserved left ventricular ejection fraction ( LVEF ) has not been fully eluci date d. This study investigated the association of cTnI with LV morphology and function , and its long-term outcome in HD patients with preserved LVEF . This prospect i ve study consists of 96 HD patients with preserved LVEF ( 69 ± 8 years and 63 % male ) who underwent two-dimensional echocardiographic examination and biomarker tests including cTnI , brain natriuretic peptide , and high-sensitive C-reactive protein . The primary endpoint was all-cause death and secondary endpoint was cardiovascular death . Factors independently associated with cTnI were systolic blood pressure ( β = − 0.239 , p = 0.011 ) , heart rate ( β = 0.216 , p = 0.021 ) , LV mass index ( β = 0.231 , p = 0.020 ) , and E to e ’ ratio ( β = 0.237 , p = 0.016 ) . During a mean follow-up of 3.6 years , primary and secondary endpoints were observed in 23 ( 24 % ) and 18 ( 19 % ) patients , respectively . In the multivariate Cox proportional hazard analysis , the upper cTnI tertile has significantly increased risk of all-cause mortality [ hazard ratio ( HR ) , 2.69 ; 95 % confidence interval ( CI ) , 1.139–6.386 ; p = 0.024 ] and that of cardiovascular death ( HR , 4.56 ; 95 % CI 2.021–16.968 ; p = 0.006 ) independent of echocardiographic measures and other serum biomarkers . In HD patients with preserved LVEF , serum cTnI levels were significantly associated with diastolic function and risk of mortality independent of echocardiographic variables and other biomarkers Aims The prognostic role of high-sensitivity C-reactive protein ( hsCRP ) in acute heart failure is less well established than for chronic heart failure and the impact of its variation is unknown . We studied the impact of hsCRP variation in acute heart failure and whether it differed according to left ventricular function . Methods We analyzed patients prospect ively included in an acute heart failure registry . Admission and discharge hsCRP were evaluated as part of the registry 's protocol and its relative variation ( & Dgr;hsCRP ) was assessed . & Dgr;hsCRP during hospitalization = [ ( admission hsCRP – discharge hsCRP)/admission hsCRP ] × 100 . Endpoint : all-cause death ; follow-up : 3 years . A multivariate Cox-regression model was used to assess the prognostic value of & Dgr;hsCRP ( continuous and categorical variable : cut-off 40 % decrease ) ; analysis was stratified according to ventricular function . Results We studied 439 patients : mean age 75 years , 50.1 % men and 69.2 % had heart failure with reduced ejection fraction ( HFrEF ) . Median discharge hsCRP was 12.4 mg/l and median & Dgr;hsCRP was ∼40 % . During follow-up 247 patients ( 56.3 % ) died : 73 ( 54.1 % ) heart failure with preserved ejection fraction ( HFpEF ) patients and 174 ( 57.2 % ) HFrEF patients . The multivariate-adjusted hazard ratio of 3-year mortality in HFpEF patients with hsCRP decrease of at least 40 % during hospitalization was 0.56 ( 95 % CI 0.32–0.99 ) . A decrease of at least 40 % in hsCRP was not mortality-associated in HFrEF patients . There was interaction between & Dgr;hsCRP and left ventricular ejection fraction . Conclusion A decrease of at least 40 % in hsCRP in acute heart failure was associated with a 44 % decrease in 3-year death risk in HFpEF patients . No association between & Dgr;hsCRP and prognosis existed in HFrEF patients . Inflammation appears to play a different role according to left ventricular function BACKGROUND Soluble ST2 ( sST2 ) is a marker of inflammation and fibrosis , which is a significant predictor of prognosis of heart failure ( HF ) , independent of brain natriuretic peptide ( BNP ) . This study aim ed to clarify how sST2 associates with clinical outcome through investigations of clinical correlates and mode of death in patients with heart failure with preserved ejection fraction ( HFpEF ) . METHODS A total 191 patients with acute decompensated HF and EF ≥50 % were prospect ively enrolled . Echocardiographic and laboratory data including sST2 were obtained in pre-discharge stable condition . RESULTS Serum sST2 level showed significant positive correlations with C-reactive protein and pentraxin3 levels , and negative correlations with body mass index , albumin , and hemoglobin . Serum sST2 level was significantly higher in patients with all-cause death and non-cardiovascular ( CV ) death compared to those without events , whereas there was no significant difference in sST2 level between patients with and without CV death . On the other h and , BNP level was significantly higher in patients with all-cause death and CV death compared to those without events . Cox regression analyses adjusted for age and sex revealed that sST2 was a significant predictor of non-CV death , whereas BNP was a significant predictor of CV death . CONCLUSIONS Serum sST2 level was associated with non-CV death showing significant correlations with systemic factors including malnutrition and inflammation , while BNP was associated with CV death
Output:
| CRP can be used as a biomarker to predict the development of HFpEF and long-term clinical outcomes in HFpEF patients , in turn justifying its use as a simple , accessible parameter to guide clinical management in this patient population . |
MS211820 | ***TASK*** the task is to summarize an input biomedical literature 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: Clinical observations have suggested a relationship between shoulder range of movement ( ROM ) and lateral epicondylalgia . This study reports the effect of a single intervention of a mobilization with movement ( MWM ) applied to the elbow , on shoulder rotation ROM in subjects with lateral epicondylalgia . Twenty-three subjects with lateral epicondylalgia were included . In a one-group pretest-post-test design , ROM of shoulder internal and external rotation were measured by goniometer before and after the application of the MWM , of both the unaffected and the affected limbs . Significant differences in pre-intervention external rotation ROM were found between unaffected and affected shoulders of subjects with lateral epicondylalgia , but no significant difference remained post-intervention . It may be concluded that restriction of shoulder rotation ROM is present in patients with lateral epicondylalgia , probably due to a facilitated level of shoulder rotator muscle tone . Shoulder internal and external rotation ROM increases significantly following MWM to the elbow , in subjects with unilateral lateral epicondylalgia . Surprisingly , these ROM increases are also apparent on the ' unaffected ' limb . These findings suggest that the MWM causes a neurophysiologically mediated decrease in resting muscle tone The treatment of lateral epicondylalgia , a widely-used model of musculoskeletal pain in the evaluation of many physical therapy treatments , remains somewhat of an enigma . The protagonists of a new treatment technique for lateral epicondylalgia report that it produces substantial and rapid pain relief , despite a lack of experimental evidence . A r and omized , double blind , placebo-controlled repeated- measures study evaluated the initial effect of this new treatment in 24 patients with unilateral , chronic lateral epicondylalgia . Pain-free grip strength was assessed as an outcome measure before , during and after the application of the treatment , placebo and control conditions . Pressure-pain thresholds were also measured before and after the application of treatment , placebo and control conditions . The results demonstrated a significant and substantial increase in pain-free grip strength of 58 % ( of the order of 60 N ) during treatment but not during placebo and control . In contrast , the 10 % change in pressure-pain threshold after treatment , although significantly greater than placebo and control , was substantially smaller than the change demonstrated for pain-free grip strength . This effect was only present in the affected limb . The selective and specific effect of this treatment technique provides a valuable insight into the physical modulation of musculoskeletal pain and requires further investigation BACKGROUND AND PURPOSE Lateral epicondylitis ( " tennis elbow " ) is a common entity . Several nonoperative interventions , with varying success rates , have been described . The aim of this study was to compare the effectiveness of 2 protocol s for the management of lateral epicondylitis : ( 1 ) manipulation of the wrist and ( 2 ) ultrasound , friction massage , and muscle stretching and strengthening exercises . SUBJECTS AND METHODS Thirty-one subjects with a history and examination results consistent with lateral epicondylitis participated in the study . The subjects were r and omly assigned to either a group that received manipulation of the wrist ( group 1 ) or a group that received ultrasound , friction massage , and muscle stretching and strengthening exercises ( group 2 ) . Three subjects were lost to follow-up , leaving 28 subjects for analysis . Follow-up was at 3 and 6 weeks . The primary outcome measure was a global measure of improvement , as assessed on a 6-point scale . Analysis was performed using independent t tests , Mann-Whitney U tests , and Fisher exact tests . RESULTS Differences were found for 2 outcome measures : success rate at 3 weeks and decrease in pain at 6 weeks . Both findings indicated manipulation was more effective than the other protocol . After 3 weeks of intervention , the success rate in group 1 was 62 % , as compared with 20 % in group 2 . After 6 weeks of intervention , improvement in pain as measured on an 11-point numeric scale was 5.2 ( SD=2.4 ) in group 1 , as compared with 3.2 ( SD=2.1 ) in group 2 . DISCUSSION AND CONCLUSION Manipulation of the wrist appeared to be more effective than ultrasound , friction massage , and muscle stretching and strengthening exercises for the management of lateral epicondylitis when there was a short-term follow-up . However , replication of our results is needed in a large-scale r and omized clinical trial with a control group and a longer-term follow-up Abstract Objective To investigate the efficacy of physiotherapy compared with a wait and see approach or corticosteroid injections over 52 weeks in tennis elbow . Design Single blind r and omised controlled trial . Setting Community setting , Brisbane , Australia . Participants 198 participants aged 18 to 65 years with a clinical diagnosis of tennis elbow of a minimum six weeks ' duration , who had not received any other active treatment by a health practitioner in the previous six months . Interventions Eight sessions of physiotherapy ; corticosteroid injections ; or wait and see . Main outcome measures Global improvement , grip force , and assessor 's rating of severity measured at baseline , six weeks , and 52 weeks . Results Corticosteroid injection showed significantly better effects at six weeks but with high recurrence rates thereafter ( 47/65 of successes subsequently regressed ) and significantly poorer outcomes in the long term compared with physiotherapy . Physiotherapy was superior to wait and see in the short term ; no difference was seen at 52 weeks , when most participants in both groups reported a successful outcome . Participants who had physiotherapy sought less additional treatment , such as non-steroidal anti-inflammatory drugs , than did participants who had wait and see or injections . Conclusion Physiotherapy combining elbow manipulation and exercise has a superior benefit to wait and see in the first six weeks and to corticosteroid injections after six weeks , providing a reasonable alternative to injections in the mid to long term . The significant short term benefits of corticosteroid injection are paradoxically reversed after six weeks , with high recurrence rates , implying that this treatment should be used with caution in the management of tennis elbow Abstract Cyriax and Cyriax advocated the use of deep transverse friction massage in combination with Mill 's manipulation in treating lateral epicondylalgia . Evidence comparing this approach with other physical therapies is lacking . The purpose of this r and omized clinical trial was to compare the effectiveness of deep transverse friction massage with Mill 's manipulation versus phonophoresis with supervised exercise in managing lateral epicondylalgia . Sixty patients age 30 - 60 , presenting with the teno-periosteal variety of lateral epicondylalgia with symptom duration greater than one month , were r and omized into two groups . The control group received phonophoresis with diclofenac gel over the area of the lateral epicondyle for 5 minutes combined with supervised exercise . The experimental group received 10 minutes of deep transverse friction massage followed by a single application of Mill 's manipulation . Both groups received treatment 3 times per week for 4 weeks . Outcomes of interest included pain via visual analog scale ( VAS ) , pain-free grip strength , and functional status measured with the Tennis Elbow Function Scale . Data were analyzed using a one-way ANOVA . Whereas both groups improved significantly from the initiation of treatment , a between-group comparison revealed significantly greater ( p<0.05 ) improvements regarding pain , pain-free grip , and functional status for the experimental group compared to the control group . The results of this study demonstrate that Cyriax physiotherapy is a superior treatment approach compared to phonophoresis and exercise in managing lateral epicondylalgia Objective : To compare the effectiveness of Cyriax physiotherapy , a supervised exercise programme , and polarized polychromatic non-coherent light ( Bioptron light ) in the treatment of lateral epicondylitis . Design : Controlled clinical trial . Setting : Rheumatology and rehabilitation centre . Subjects : This study was carried out with 75 patients who had lateral epicondylitis . They were allocated to three groups by sequential allocation . Interventions : Group A ( n=25 ) was treated with Cyriax physiotherapy . A supervised exercise programme was given to group B ( n=25 ) . Group C ( n=25 ) received polarized polychromatic non-coherent light ( Bioptron light ) . All patients received three treatments per week for four weeks . Outcomes : Pain was evaluated using a visual analogue scale and function using a visual analogue scale and pain-free grip strength at the end of the four-week course of treatment ( week 4 ) , one month ( week 8) , three months ( week 16 ) and six months ( week 28 ) after the end of treatment . Results : The supervised exercise programme produced the largest effect in the reduction of pain and in the improvement of function at the end of the treatment ( P<0.05 ) and at any of the follow-up time points ( P<0.05 ) . Conclusion : The supervised exercise programme should be the first treatment option for therapists when they manage lateral epicondylitis patients . If this is not possible , Cyriax physiotherapy and polarized polychromatic non-coherent light ( Bioptron light ) may be suitable This preliminary study indicates the proportion of patients with lateral epicondylalgia that demonstrate a favourable initial response to a manual therapy technique - the mobilization with movement ( MWM ) for tennis elbow . Twenty-five subjects with lateral epicondylalgia participated . In a one-group pretest - post-test design , we measured ( 1 ) pain with active motion , ( 2 ) pain-free grip strength and , ( 3 ) maximum grip strength before and after a single intervention of MWM . Results of the study indicate that MWM was effective in allowing 92 % of subjects to perform previously painful movements pain-free , and improving grip strength immediately afterwards . Significant differences were found between the grip strength of the affected and unaffected limbs prior to the intervention . Both pain-free grip strength and maximum grip strength of the affected limb increased significantly following the intervention . Pain-free grip strength increased by a greater magnitude than maximum grip strength . It can be concluded that MWM is a promising intervention modality for the treatment of patients with Lateral Epicondylalgia . Pain-free grip strength is a more responsive measure of outcome than maximum grip strength for patients with Lateral Epicondylalgia . Further research is warranted to investigate the long-term effectiveness of MWM in the treatment of impairment and disability result ing from Lateral Epicondylalgia BACKGROUND AND PURPOSE Mulligan has proposed the use of mobilization with movement for lateral epicondylalgia . In this study , mobilization with movement for the elbow was examined to determine whether this intervention was capable of inducing physiological effects similar to those reported for some forms of spinal manipulation . PARTICIPANTS Seven women and 17 men ( mean age=48.5 years , SD=7.2 ) with chronic lateral epicondylalgia participated in the study . METHODS A placebo , control , repeated- measures study was conducted to evaluate whether mobilization with movement at the elbow produced concurrent hypoalgesia and sympathoexcitation . RESULTS The treatment demonstrated an initial hypoalgesic effect and concurrent sympathoexcitation . Improvements in pain result ed in increased pain-free grip force and pressure pain thresholds . Sympathoexcitation was indicated by changes in heart rate , blood pressure , and cutaneous sudomotor and vasomotor function . DISCUSSION AND CONCLUSION This study showed that a mobilization with movement treatment technique exerted a physiological effect similar to that reported for some spinal manipulations We performed a prospect i ve , r and omised trial on 106 patients to compare the effects of local corticosteroid injections with physiotherapy as advocated by Cyriax in the treatment of tennis elbow . The main outcome measures were the severity of pain , pain provoked by resisted dorsiflexion of the wrist , and patient satisfaction . At six weeks 22 of 53 patients in the injection group were free from pain compared with only three in the physiotherapy group . In the corticosteroid-treated group 26 patients had no pain on resisted dorsiflexion of the wrist compared with only three in the physiotherapy group . Thirty-five patients who had injections and 14 who had physiotherapy were satisfied with the outcome of treatment at six weeks . At the final assessment there were 18 excellent and 18 good results in the corticosteroid group and one excellent and 12 good results in the physiotherapy group . There was a significant increase in grip strength in both groups but those with injections had a significantly better result . After one year there were no significant differences between the two groups . Half of the patients , however , had received only the initial treatment , 20 % had had combined therapy and 30 % had had surgery . We conclude that at six weeks , treatment with corticosteroid injections was more effective than Cyriax physiotherapy and we recommend it because of its rapid action , reduction of pain and absence of side-effects Carpal tunnel syndrome is the most common peripheral entrapment neuropathy . There is little literature available that addresses the management of this condition , which may partly explain why physiotherapy is often overlooked as a treatment approach in its management . This study investigated the effects of two manual therapy techniques in the treatment of patients experiencing carpal tunnel syndrome . An experimental different subject design compared three groups of subjects in three different conditions ( two treatment interventions and one control group ) . Each group consisted of seven patients . The objectives of the study were : ( 1 ) to investigate differences between treated and untreated groups ; ( 2 ) to investigate differences in the effectiveness of treatment I ( median nerve mobilization ) compared with treatment II ( carpal bone mobilization ) . Measurements were taken applying several measurement tools , including active range of wrist movement ( ROM flexion and extension ) , upper limb tension test with a median nerve bias ( ULTT2a ) , three different scales to evaluate pain perception and function , and lastly numbers of patients continuing to surgery in each group were compared . In visual terms a clear trend was demonstrated between subjects who received treatment compared to those who were not treated , in particular the
Output:
| RESULTS The current evidence provides moderate support for the inclusion of joint mobilizations in the treatment of lateral epicondylalgia ( LE ) .
Other described techniques include those known as Kaltenborn , Cyriax physical therapy , and Maitl and , but the evidence for these techniques is limited .
There is also limited evidence for the joint mobilizations in the treatment of wrist and h and conditions .
The current literature offers limited support for joint mobilizations of the wrist and h and , and moderate support for joint mobilizations of the elbow for LE .
There is moderate support for mobilization with movement .
|
MS211821 | ***TASK*** the task is to summarize an input biomedical literature 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: Relationships among risky sexual behaviors , other problem behaviors , and the family and peer context were examined for two sample s of adolescents . Many adolescents reported behaviors ( e.g. , promiscuity or nonuse of condoms ) which risked HIV or other sexually transmitted disease infection . Such risky behaviors were significantly intercorrelated . Consistent condom use was rare among those whose behavior otherwise entailed the greatest risk of infection . In both sample s , an index of high-risk sexual behavior was significantly related to antisocial behavior , cigarette smoking , and illicit drug or alcohol use . Social context variables , including family structure , parenting practice s , and friends ' engagement in problem behaviors , were associated with high-risk sexual behavior . Finally , for sexually active adolescents , problem behaviors and social context variables were predictive of nonuse of condoms . Results were consistent across the two studies and regression weights held up well under cross-validation Little is known about early life diet as a risk factor for early-onset persistent conduct problems ( EOP CP ) . To investigate this , we used data from the Avon Longitudinal Study of Parents and Children , a UK-based prospect i ve epidemiological birth cohort . 5727 mother-child pairs ( 49.9 % boys ) monitored since pregnancy ( delivery date between 1 April , 1991 and 31 December , 1992 ) reported intake of fish and processed foods at 32 weeks gestation and , for the child , at 3 years ; EOP ( n = 666 ) and Low conduct problem ( Low CP , n = 5061 ) trajectories were measured from 4 to 13 years ; hyperactivity and emotional difficulties were assessed in childhood ( 4–10 years ) and early adolescence ( 12–13 years ) , in addition to potential confounding factors ( family adversity , birth complications , income ) . Compared to Low CP , mothers of EOP children consumed less fish ( p < 0.01 ) and more processed food ( p < 0.05 ) prenatally , while EOP children consumed more processed food at 3 years ( p < 0.05 ) . For EOP , but not Low CP children , consuming less than two servings/week of fish ( vs. two or more servings/week , p < 0.05 ) , and one or more servings/day of processed food ( vs. less than one serving/day , p < 0.01 ) , was associated with higher emotional difficulties in early adolescence . Conclusions : Findings suggest that prenatal and postnatal diets high in processed food , and low in fish , associate with an EOP CP trajectory and co-occurring difficulties in early adolescence . As small effect size differences were found , further studies are needed to investigate the long-term impact of early unhealthy diet Largely because of the influence of Moffitt 's useful distinction between adolescence-limited and life-course persistent antisocial behavior , it has become increasingly common to view problem behavior that makes its first appearance in adolescence as developmentally normative . This study prospect ively examined the lives of individuals in the NICHD Study of Early Child Care and Youth Development whose patterns of antisocial behavior varied with respect to age of onset and stability from kindergarten through age 15 . Consistent with past research , early-onset , persistently deviant youth experienced more context ual adversity and evinced higher levels of intraindividual disadvantages than their peers from infancy through midadolescence . However , relative to youth who never showed significantly elevated antisocial behavior through age 15 , children who showed antisocial behavior primarily in adolescence also were more disadvantaged from infancy forward , as were youth who only demonstrated significant externalizing problems in childhood . Findings generally replicated across sex and did not vary as a function of whether antisocial behavior groups were defined using T-scores normed within sex or identified using an empirically driven grouping method applied to raw data Moffitt 's theory regarding two types of adolescent antisocial behavior was investigated using a prospect i ve , longitudinal study of normal and abnormal development in a primarily low socioeconomic status , ethnically diverse sample . Results supported the presence of an early-onset/persistent ( EOP ) group and an adolescence-onset ( AO ) group . Groups were most reliably and significantly distinguished by indices of socioemotional history within the first 3 years , but no significant differences were found on early measures of temperament or neuropsychological functioning . EOPs scored significantly lower than other groups on measures of neuropsychological functioning only during late childhood and adolescence , suggesting that the declines in verbal functioning that have been so reliably found in this and other sample s of early-starting antisocial adolescents are progressive and consequent to adverse experience . In adolescence , AOs were significantly more likely to report high levels of internalizing symptoms and life stress , suggesting that AO antisocial behavior is not a benign phenomenon . Implication s of these findings for etiologic theories of adolescent antisocial behavior are discussed CONTEXT A cardinal feature of the DSM-IV diagnostic criteria for conduct disorder is the distinction between childhood- vs adolescent-onset subtypes . Whether such developmental subtypes exist in the population and have different prognoses should be rigorously tested to inform the DSM-V. OBJECTIVES To evaluate the epidemiological validity of childhood- vs adolescent-onset conduct problems in a prospect i ve birth cohort , and to assess whether life-course-persistent conduct problems are associated with a greater adult health burden . DESIGN , SETTING , AND PARTICIPANTS Our sample includes 526 male study members in the Dunedin Multidisciplinary Health and Development Study , a 1-year birth cohort ( April 1 , 1972 , through March 30 , 1973 ) . Developmental trajectories were defined using prospect i ve ratings of conduct problems at 7 , 9 , 11 , 13 , 15 , 18 , 21 , and 26 years of age . MAIN OUTCOME MEASURES Health burden was assessed as mental and physical health problems at 32 years of age measured via diagnostic interviews and physical examinations . RESULTS We identified the following 4 developmental subtypes of conduct problems through general growth mixture modeling : ( 1 ) childhood-onset/life-course-persistent , ( 2 ) adolescent onset , ( 3 ) childhood limited , and ( 4 ) low . At 32 years of age , study members with the life-course-persistent subtype experienced the worst health burden . To a lesser extent , those with the adolescent-onset subtype also experienced health problems . A childhood-limited subtype not specified by DSM-IV was revealed ; its adult health outcomes were within the range of the cohort norm . CONCLUSIONS Results support the epidemiological validity of the DSM-IV conduct disorder distinction based on age of onset but highlight the need to also consider long-term persistence to refine diagnosis . Preventing and treating conduct problems has the potential to reduce the adult health burden The prospect i ve relationships of conduct problems and peer coercion and deviancy training during kindergarten ( mean age = 5.3 years ) to overt and covert conduct problems in third-fourth grade were examined in a sample of 267 boys and girls . Coercion and deviancy training were distinct peer processes . Both were associated with earlier child conduct problems but were differentially associated with child impulsivity , verbal ability , anxiety , peer rejection , and deviant peer affiliation . Coercion by peers predicted overt conduct problems and peer deviancy training and the interaction of deviancy training and coercion predicted covert conduct problems in third-fourth grade . Peer deviancy training occurs in early childhood and may serve as an independent risk mechanism in addition to peer coercion for early-onset , persisting conduct problems 76 9 - 12 yr old aggressive males were assigned to anger-coping , goal - setting , anger-coping plus goal - setting , or no-treatment groups . Anger-coping interventions were school-based secondary prevention efforts that utilized social problem-solving and cognitive-behavioral techniques . At 1-mo followup , Ss who received anger-coping treatment had reduced their aggressive behavior in the classroom and at home and displayed improved self-esteem . ( 5 ref ) VioLit summary OBJECTIVE : The objective of this study by Lochman et al. was to observe the treatment and generalization effects of cognitive-behavioral and goal - setting interventions with aggressive boys . METHODOLOGY : An experimental design was used within a cognitive-behavioral framework , using a 2X2 factorial design to compare the separate and combined effects of a cognitive-behavioral condition , and a less intensive goal - setting condition . The 4 experimental cells were anger coping , goal setting , anger coping plus goal setting , and an untreated control cell . 76 boys , 9 - 12 years of age , from 8 elementary schools , were chosen via having the highest teacher ratings of aggression on the Missouri Children 's Behavior Checklist . These youth were assigned to cells on a rotating basis . FINDINGS / DISCUSSION : Children in the anger-coping cells displayed significant improvement over time versus subjects not in the anger-coping cells . Anger-coping plus goal - setting subjects significantly reduced their scores in comparison to subjects in the untreated control cell . The goal setting procedure tended to augment the treatment effects in the classroom . Despite indications in intervention , significant changes were not evident to teachers and peers , which may have been a result of limited treatment effects and rigid perceptions of the boys ' reputations . ( CSPV Abstract - Copyright © 1992 - 2007 by the Center for the Study and Prevention of Violence , Institute of Behavioral Science , Regents of the University of Colorado ) KW - Late Childhood KW - Child Anger KW - Child Aggression KW - Child Male KW - Child Treatment KW - Male Anger KW - Male Aggression KW - Aggression Treatment KW - Aggression Intervention KW - Cognitive Behavioral Treatment KW - Cognitive Behavioral Intervention KW - Anger Management KW - Goal Setting KW - Treatment Effectiveness Language :
Output:
| Overall , EOP individuals showed significant higher risk of poor outcome followed by AO individuals , CL individuals , and finally participants in the low group .
All conduct problems trajectories showed higher risk of poor psychosocial outcomes compared to the low group , but the magnitude of risk differed across trajectories , with a general trend for the EOP to perform significantly worse , followed by the AO and CL . |
MS211822 | ***TASK*** the task is to summarize an input biomedical literature 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 investigate the performance of a novel assay for N-terminal pro-brain natriuretic peptide ( NT-proBNP ) in diagnosing heart failure in various r and omly selected general and high risk community population s. Design : Community cohort study ( sub study of the echocardiographic heart of Engl and screening study ) . Setting : Four r and omly selected general practice s in the West Midl and s of Engl and . Participants : 591 r and omly sample d patients over the age of 45 , stratified for age and socioeconomic status and falling into four cohorts ( general population , patients with an existing clinical label of heart failure , patients prescribed diuretics , and patients deemed at high risk of heart failure ) . Main outcome measure : Sensitivity , specificity , positive and negative predictive values , likelihood ratios , and area under receiver operating characteristic curve for NT-proBNP assay in the diagnosis of heart failure . Results : For NT-proBNP in the diagnosis of heart failure in the general population ( population screen ) , a level of > 36 pmol/l had a sensitivity of 100 % , a specificity of 70 % , a positive predictive value of 7 % , a negative predictive value of 100 % , and an area under the receiver operating characteristic curve of 0.92 ( 95 % confidence interval 0.82 to 1.0 ) . Similar negative predictive values were found for patients from the three other population s screened . Conclusions : This NT-proBNP assay seems to have value in the diagnosis of heart failure in the community . High negative predictive values indicate that the assay 's chief use would be to rule out heart failure in patients with suspected heart failure with normal concentrations of NT-proBNP . Positive results may identify patients who need cardiac imaging CONTEXT Several reports have suggested the usefulness of plasma brain natriuretic peptide ( BNP ) as a screening test for left ventricular hypertrophy ( LVH ) and systolic dysfunction ( LVSD ) . Prior studies were limited by small sample sizes and selection bias and none compared the diagnostic performance of these peptides in men and women . OBJECTIVES To examine the usefulness of natriuretic peptides for screening for elevated LV mass and LVSD in the community . DESIGN , SETTING , AND PARTICIPANTS Community-based prospect i ve cohort study of 3177 participants ( 1707 women ) from the Framingham Study who attended a routine examination in 1995 - 1998 . MAIN OUTCOME MEASURES Receiver operating characteristic ( ROC ) curves , test sensitivity , specificity , positive and negative predictive values , and likelihood ratios for identifying elevated LV mass ( sex-specific 90th percentile or higher of LV mass/[height](2 ) ) , LVSD ( ejection fraction < or = 50 % and /or fractional shortening < 29 % ) , and moderate to severe LVSD ( ejection fraction < or = 40 % and /or fractional shortening < 22 % ) at different discrimination limits of plasma BNP and N-terminal proatrial natriuretic peptide ( NT-ANP ) , with echocardiography as the criterion st and ard . RESULTS The areas under the ROC curves for elevated LV mass or LVSD were at or below 0.75 for both peptides , were higher for men compared with women , and were similar for BNP and NT-ANP . The diagnostic performance of natriuretic peptides for LVSD improved in women but not in men when select high-risk subgroups were targeted . Discrimination limits based on high specificity ( 0.95 ) yielded better positive predictive values and likelihood ratios compared with age- and sex-specific reference limits yet only identified less than one third of participants who had elevated LV mass or LVSD . CONCLUSION In our large community-based sample , the performance of BNP and NT-ANP for detection of elevated LV mass and LVSD was suboptimal , suggesting limited usefulness of natriuretic peptides as mass screening tools BACKGROUND The aim of the study was to prospect ively evaluate patients with suspected or known heart disease using plasma brain natriuretic peptide ( BNP ) measurement and radionuclide ventriculography to examine whether left ventricular dysfunction is associated with an abnormal rise of BNP concentration . METHODS Patients ( n=153 ) and controls ( n=14 ) underwent radionuclide ventriculography to determine Left ventricular Ejection Fraction ( LVEF ) and measurement of plasma BNP concentration using a commercial kit . RESULTS Plasma BNP concentration in controls was significantly lower than that in patients whatever the stage of the disease , significantly lower than that of patients with normal LVEF ( LVEF>55 % ) ; than that of patients with altered LVEF ( LVEF < or = 40 % ) ; and than that of patients with moderately reduced LVEF ( 40%<LVEF < or = 5 % ) . Comparisons between groups of patients showed that the more severe the disease , the higher the BNP level . From the ROC curve , a plasma BNP concentration of 52 pg/ml was attached to a 85 % sensitivity and 82 % specificity in identifying patients with LVEF < or = 40 % . CONCLUSIONS Plasma BNP concentration provides a reliable and sensitive marker of LV systolic dysfunction evaluated by a nuclear medicine technique , and could be a potential screening test to identify patients for additional investigations BACKGROUND B-type natriuretic peptide is released from the cardiac ventricles in response to increased wall tension . METHODS We conducted a prospect i ve study of 1586 patients who came to the emergency department with acute dyspnea and whose B-type natriuretic peptide was measured with a bedside assay . The clinical diagnosis of congestive heart failure was adjudicated by two independent cardiologists , who were blinded to the results of the B-type natriuretic peptide assay . RESULTS The final diagnosis was dyspnea due to congestive heart failure in 744 patients ( 47 percent ) , dyspnea due to noncardiac causes in 72 patients with a history of left ventricular dysfunction ( 5 percent ) , and no finding of congestive heart failure in 770 patients ( 49 percent ) . B-type natriuretic peptide levels by themselves were more accurate than any historical or physical findings or laboratory values in identifying congestive heart failure as the cause of dyspnea . The diagnostic accuracy of B-type natriuretic peptide at a cutoff of 100 pg per milliliter was 83.4 percent . The negative predictive value of B-type natriuretic peptide at levels of less than 50 pg per milliliter was 96 percent . In multiple logistic-regression analysis , measurements of B-type natriuretic peptide added significant independent predictive power to other clinical variables in models predicting which patients had congestive heart failure . CONCLUSIONS Used in conjunction with other clinical information , rapid measurement of B-type natriuretic peptide is useful in establishing or excluding the diagnosis of congestive heart failure in patients with acute dyspnea BACKGROUND In previous studies on the use of natriuretic peptides to detect left-ventricular systolic dysfunction , a higher rate of cardiac disorders in the control groups than in the study groups could have led to bias . We investigated the effectiveness of plasma N-terminal atrial natriuretic peptide ( NT-ANP ) and brain natriuretic peptide ( BNP ) concentrations to show left-ventricular systolic dysfunction in a r and om sample of the general population . METHODS We r and omly selected 2000 participants aged 25 - 74 years from family physicians ' lists in Glasgow , UK . We sent all participants question naires . 1653 respondents underwent echocardiography and electrocardiography . We took a left-ventricular ejection fraction of 30 % or less to show left-ventricular systolic dysfunction . NT-ANP and BNP were measured in plasma by RIAs . FINDINGS 1252 participants had analysable electrocardiograms and echocardiograms , completed question naires , and available blood sample s. Median concentrations of NT-ANP and BNP were significantly higher in participants with left-ventricular systolic dysfunction ( 2.8 ng/mL [ IQR 1.8 - 4.6 ] and 24.0 pg/mL [ 18.0 - 33.0 ] ) than in those without ( 1.3 ng/mL [ 0.9 - 1.8 ] and 7.7 pg/mL [ 3.4 - 13.0 ] ; each p < 0.001 ) . Among participants with left-ventricular systolic dysfunction , both symptomatic and asymptomatic subgroups had raised NT-ANP and BNP concentrations . A BNP concentration of 17.9 pg/mL or more gave a sensitivity of 77 % and specificity of 87 % in all participants , and 92 % and 72 % in participants aged 55 years or older . INTERPRETATION Measurement of BNP could be a cost-effective method of screening for left-ventricular systolic dysfunction in the general population , especially if its use were targeted to individuals at high risk BACKGROUND In the studies of left ventricular dysfunction ( SOLVD ) , enalapril reduced mortality in patients with symptomatic but not asymptomatic left ventricular systolic dysfunction during the trial . We did a 12-year follow-up of SOLVD to establish if the mortality reduction with enalapril among patients with heart failure was sustained , and whether a subsequent reduction in mortality would emerge among those with asymptomatic ventricular dysfunction . METHODS Of the 6797 patients previously enrolled in the SOLVD prevention and treatment trials , we ascertained the subsequent vital status of 5165 individuals who were alive when the trials had been completed . Follow-up was done through direct contacts in Belgium and linkages with national death registries and federal beneficiary or historic tax summary files in the USA and Canada . FINDINGS Follow-up was 99.8 % ( 6784/6797 ) complete . In the prevention trial , 50.9 % ( 1074/2111 ) of the enalapril group had died compared with 56.4 % ( 1195/2117 ) of the placebo group ( generalised Wilcoxon p=0.001 ) . In the treatment trial , 79.8 % ( 1025/1285 ) of the enalapril group had died compared with 80.8 % ( 1038/1284 ) of the placebo group ( generalised Wilcoxon p=0.01 ) . The reductions in cardiac deaths were significant and similar in both trials . When data for the prevention and treatment trials were combined , the hazard ratio for death was 0.90 for the enalapril group compared with the placebo group ( 95 % CI 0.84 - 0.95 , generalised Wilcoxon p=0.0003 ) . Enalapril extended median survival by 9.4 months in the combined trials ( 95 % CI 2.8 - 16.5 , p=0.004 ) . INTERPRETATION Treatment with enalapril for 3 - 4 years led to a sustained improvement in survival beyond the original trial period in patients with left ventricular systolic dysfunction , with an important increase in life expectancy BACKGROUND The reliability of a clinical diagnosis of heart failure in primary care is poor . Concentrations of natriuretic peptides are high in heart failure . This population -based study examined the predictive value of natriuretic peptides in patients with a new primary -care diagnosis of heart failure . METHODS Concentrations of plasma atrial ( ANP and N-terminal ANP ) and B-type ( BNP ) natriuretic peptides were measured by radioimmunoassay in 122 consecutive patients referred to a rapid-access heart-failure clinic with a new primary -care diagnosis of heart failure . On the basis of clinical assessment , chest radiography , and transthoracic echocardiography , a panel of three cardiologists decided that 35 ( 29 % ) patients met the case definition for new heart failure . ANP and NT-ANP results were available for 117 patients ( 34 with heart failure ) and BNP results for 106 ( 29 with heart failure ) . FINDINGS Geometric mean concentrations of natriuretic peptides were much higher in patients with heart failure than in those with other diagnoses ( 29.2 vs 12.4 pmol/L for ANP ; 63.9 vs 13.9 pmol/L for BNP ; 1187 vs 410.6 pmol/L for NT-ANP ; all p < 0.001 ) . At cut-off values chosen to give negative predictive values for heart failure of 98 % ( ANP > or = 18.1 pmol/L , NT-ANP > or = 537.6 pmol/L , BNP > or = 22.2 pmol/L ) , the sensitivity , specificity , and positive predictive value for ANP were 97 % , 72 % , and 55 % ; for NT-ANP 97 % , 66 % , and 54 % ; and for BNP 97 % , 84 % , and 70 % . Addition of ANP or NT-ANP concentration or both did not improve the predictive power of a logistic regression model containing BNP concentration alone . INTERPRETATION In patients with symptoms suspected by a general practitioner to be due to heart failure
Output:
| The use of BNP tests to rule out CHF in primary care setting s could reduce dem and for echocardiography . |
MS211823 | ***TASK*** the task is to summarize an input biomedical literature 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 Growth faltering during infancy is a characteristic of life in developing countries . Previous studies have shown that small-intestine mucosal enteropathy , accompanied by endotoxemia and a persistent systemic inflammatory response , accounts for up to 64 % of the growth faltering in Gambian infants . OBJECTIVE The objective was to test whether glutamine , with its putative trophic effects on enterocytes , immune cells , and intestinal integrity , can accelerate the repair of the intestine , lower immunostimulation , and reduce growth faltering . DESIGN Ninety-three infants aged 4 - 10 mo from the West Kiang region of The Gambia were studied in a double-blind , double-placebo , controlled trial . Glutamine ( 0.25 mg/kg body wt ) or a placebo that contained an isonitrogenous , isoenergetic mix of nonessential amino acids was orally administered twice daily throughout the 5-mo rainy season . Anthropometric measurements were made monthly during the supplementation period and for 6 mo after supplementation . Intestinal permeability was measured monthly ( by determining the ratio of lactulose to mannitol ) , and finger-prick blood sample s were collected for the analysis of plasma proteins on 3 occasions . RESULTS Gambian infants showed a seasonal deterioration in growth and persistently elevated acute phase protein concentrations and intestinal permeability . Oral supplementation with glutamine did not improve growth ( x + /- SE : weight gain , 60 + /- 19 and 69 + /- 20 g/mo ; length gain , 1.01 + /- 0.05 and 0.95 + /- 0.03 cm/mo ) or intestinal permeability [ lactulose : mannitol ratio : 0.29 ( 95 % CI : 0.23 , 0.35 ) and 0.26 ( 95 % CI : 0.21 , 0.32 ) ] in the glutamine and placebo groups , respectively . It also had no effect on infant morbidity or on plasma concentrations of immunoglobulins or acute phase proteins . CONCLUSION Glutamine supplementation failed to improve growth or intestinal status in malnourished Gambian infants BACKGROUND The effect of helminth infestation on the nutrition , growth , and physiology of the host is still poorly understood . Anthelmintic treatment of children in developing countries has had varying success in terms of growth improvements . OBJECTIVE The objective of this study was to assess the effect of regular deworming on child growth , physiology , and biochemical status . DESIGN The study was a 12-mo longitudinal intervention in 123 Bangladeshi children aged 2 - 5 y. Treatment ( mebendazole ) or placebo tablets were administered every 2 mo for 8 mo and again at 12 mo . Weight , height , midupper arm circumference , intestinal permeability , plasma albumin , alpha(1)-antichymotrypsin , and total protein concentration were assessed every 2 mo . RESULTS Treatment with mebendazole reduced the prevalence of Ascaris lumbricoides from 78 % to 8 % , of Trichuris trichiura from 65 % to 9 % , and of hookworm from 4 % to 0 % . There was no significant difference in the growth of treated children compared with those given placebo tablets . No changes in intestinal permeability or plasma albumin were observed after deworming . Significant decreases in total protein ( P<0.001 ) and alpha(1)-antichymotrypsin ( P<0.001 ) were observed in the treatment group , indicating possible reductions in inflammation and immunoglobulin concentration after deworming . A significant increase in the prevalence of Giardia intestinalis ( from 4 % to 49 % ) in the treatment group was associated with a short-term reduction in weight ( P = 0.02 ) and higher intestinal permeability ( P < 0.001 ) in infected subjects . No long-term effects of G. intestinalis on growth were observed . CONCLUSION Low-intensity helminth infections , predominantly of A. lumbricoides and T. trichiura , do not contribute significantly to the poor growth and biochemical status of rural Bangladeshi children BACKGROUND Tropical enteropathy is an asymptomatic villous atrophy of the small bowel that is prevalent in the developing world and is associated with altered intestinal function and integrity . The histology of tropical enteropathy resembles that seen in small-bowel bacterial overgrowth . OBJECTIVE This study tested the hypothesis that treatment of 3 - 5-y-old Malawian children with the probiotic Lactobacillus GG would improve their intestinal function and integrity . DESIGN Clinical ly healthy children ( n = 164 ) were enrolled in a placebo-controlled , r and omized , double-blind trial . Intestinal function and integrity were measured by using the site-specific sugar-absorption test before and after 30 d of treatment with Lactobacillus GG or placebo . The primary outcomes were the ratios of urinary lactulose to mannitol ( L : M ) and of urinary sucrose to lactulose ( S : L ) excretion . RESULTS Of the 161 children who completed the study , 119 ( 73 % ) had tropical enteropathy on enrollment ( L : M > 0.10 ) . Children receiving Lactobacillus GG did not differ significantly from the placebo group in the excretion ( in % of dose administered ) of mannitol ( mean + /- SD : 8.9 + /- 4.4 and 8.9 + /- 3.9 , respectively ) , lactulose ( 0.31 + /- 0.20 and 0.33 + /- 0.23 , respectively ) , or sucrose ( 0.078 + /- 0.058 and 0.082 + /- 0.075 , respectively ) . L : M and S : L also did not differ significantly between the Lactobacillus and placebo groups ( 0.19 + /- 0.13 and 0.20 + /- 0.12 , respectively , for L : M ; 0.58 + /- 0.46 and 0.65 + /- 0.57 , respectively , for S : L ) . CONCLUSION Administration of Lactobacillus GG for 30 d had no effect on the intestinal integrity of 3 - 5-y-old Malawian children The interrelationship between diarrhea , malnutrition , and small bowel integrity was investigated prospect ively in 68 Gambian infants aged 0 - 18 mo . Profiles of growth and morbidity were recorded for 8 mo . Each month intestinal permeability was measured by the differential uptake of orally administered lactulose ( L ) and mannitol ( M ) . In well infants the mean L : M ratio was 0.42 ( range 0.11 - 1.42 ) . This ratio was increased slightly for underweight ( 60 - 80 % wt for age ) infants ( mean 0.52 ) but considerably for those with marasmus ( less than 60 % wt for age ) ( mean 1.3 , p less than 0.001 ) , for those with acute or chronic diarrhea ( mean 1.0 and 2.85 , respectively ; p less than 0.001 ) , or with measles ( mean 1.4 , p less than 0.001 ) . Sequential studies of ward patients with malnutrition and diarrhea showed a rapid fall in L : M ratios with resolution of diarrhea . These studies suggest that damage to the small intestine may play an important part in the development of infant malnutrition in The Gambia Background : This study evaluates the effects of retinol on intestinal barrier function , growth , total parasites , and Giardia spp infections in children in northeastern Brazil . Subjects and Methods : The study was a double-blind , r and omized placebo-controlled trial ( http:// clinical trials.gov ; register no. # NCT00133406 ) involving 79 children who received vitamin A 100,000–200,000 IU ( n = 39 ) or placebo ( n = 40 ) at enrollment , 4 , and 8 months and were followed for 36 months . Intestinal barrier function was evaluated using the lactulose : mannitol ratio test . Stool lactoferrin was used as a marker for intestinal inflammation . Results : The groups were similar with regard to age , sex , nutritional parameters ( z scores ) , serum retinol concentrations , proportion of lactoferrin-positive stool sample s , and intestinal barrier function . The lactulose : mannitol ratio did not change during the same time of follow-up ( P > 0.05 ) . The proportion of lactoferrin-positive sample s evaluated at 1 month did not change between groups ( P > 0.05 ) . Total intestinal parasitic , specifically new , infections were significantly lower in the vitamin A treatment compared with control group ; these were accounted for entirely by significantly fewer new Giardia infections in the vitamin A treatment group . The cumulative z scores for weight-for-length or height , length or height-for-age z scores , and weight-for-age did not change significantly with vitamin A intervention for 36 months of follow-up . Conclusions : These data showed that total parasitic infection and Giardia spp infections were significantly lower in the vitamin A treatment group when compared with the placebo group , suggesting that vitamin A improves the host 's defenses against Giardia infections In order to test the impact of Giardia and geohelminthic infection on infant growth faltering in Bangladesh , a r and omised double-blind placebo controlled intervention of 36 weeks ' duration was conducted in a rural community located 40 km northwest of Dhaka . Infants aged between 3 and 15 months were r and omly assigned to either anti-Giardia and anthelminthic treatment , anti-Giardia treatment only , or a control . Weight and supine length were recorded every 4 weeks . Every 12 weeks intestinal permeability ( lactulose/mannitol ratio ) , haemoglobin , plasma albumin , alpha-1-acid glycoprotein , IgG and Giardia-specific IgM ( GSIgM ) and eggs of the three common geohelminths and G. intestinalis cysts were determined . Data on 222 fully compliant infants were analysed . No significant differences in intestinal permeability , biochemical or anthropometric variables were found between the intervention groups , although there were associations between improvement in small intestinal mucosal function and better weight-for-age and weight-for-height ( length ) Z-scores . GSIgM titres indicated high endemicity with rapid re-infection of Giardia among infants ; over 95 % of infants were positive throughout the study , whereas the stool examination showed very few infants with either geohelminth eggs or Giardia cysts Sub clinical mastitis , as diagnosed by an elevated sodium/potassium ratio in milk accompanied by an increased milk concentration of the inflammatory cytokine , interleukin-8 ( IL8 ) , was found to be common among breast feeding women in Bangladesh and Tanzania . Sub clinical mastitis results in leakage of plasma constituents into milk , active recruitment of leukocytes into milk , and possible infant gut damage from inflammatory cytokines . Therefore , we wished to investigate whether sub clinical mastitis was related to known risk factors for postnatal mother-to-child HIV transmission , that is , high milk viral load or increased infant gut permeability . HIV-infected South African women were recruited at the antenatal clinic of McCord 's Hospital , Durban . Risks and benefits of different feeding strategies were explained to them and , if they chose to breast feed , they were encouraged to do so exclusively . Women and infants returned to the clinic at 1 , 6 and 14 weeks postpartum for an interview about infant health and current feeding pattern , a lactulose/mannitol test of infant gut permeability , and milk sample collection from each breast separately for analysis of Na/K ratio , IL8 concentration and viral load in the cell-free aqueous phase . Only preliminary cross-sectional analyses from an incomplete data base are available at this point . Moderately ( 0.6 - 1.0 ) or greatly ( > 1.0 ) raised Na/K ratio was common and was often unilateral , although as a group right and left breasts did not differ . Considering both breasts together , normal , moderately raised or greatly raised Na/K was found , respectively , in 51 % , 28 % , 21 % of milk sample s at 1 week ( n=190 ) ; 69 % , 20 % , 11 % at 6 weeks ( n=167 ) ; and 72 % , 16 % , 12 % at 14 weeks ( n=122 ) . IL8 concentration significantly correlated with both Na/K and viral load at all times . Na/K correlated with viral load at 1 and 14 , but not 6 weeks . At 1 and 14 weeks , geometric mean viral loads in sample s with Na/K > 1.0 were approximately 4 times those in sample s with Na/K < 0.6 . At 1 week but not later times , exclusive breast feeding was associated with lower milk viral load than was mixed feeding . Gut permeability was unrelated to milk Na/K ratio or IL8 concentration and was not significantly increased by inclusion of other foods than breast milk in
Output:
| We conclude that the L : M test has many attributes , including reflecting 2 physiologic processes ( absorption and permeability ) and likely correlation with growth failure consequent to child gut dysfunction . |
MS211824 | ***TASK*** the task is to summarize an input biomedical literature 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: Biondi , Fazio , and colleagues recently reported that long term T4 treatment to suppress serum TSH markedly affects cardiac function . T4-treated patients had more symptoms [ 12.2 + /- 3.9 ( + /-SD ) vs. 4.2 + /- 2.3 by quantitative question naire ] , higher mean heart rate , increased incidence of atrial extrasystoles , increased interventricular septal thickness and left ventricular mass index ( LVMi ) , and significant diastolic dysfunction . The severity of cardiac abnormalities was highly correlated with scores of a rating scale used for assessing symptoms of thyrotoxicosis . We have duplicated their studies in 17 athyreotic patients ( mean age , 45 + /- 10 yr ; range , 27 - 63 yr ) without heart disease or hypertension whose dose of T4 was titrated to suppress serum TSH to less than 0.01 microU/mL. The mean duration of T4 treatment was 9.2 + /- 5.4 yr . Controls were healthy volunteers matched for sex and age ( + /-3 yr ) . The mean T4 dose was 2.8 + /- 0.9 micrograms/kg ( 0.192 + /- 0.058 mg/day ) . By question naire , patients had minimal symptoms , although their symptom score was significantly greater than the control value ( 4 + /- 3 vs. 2 + /- 1 ; P < 0.05 ; maximum score , 36 ) . No differences in mean heart rate or in atrial or ventricular extrasystoles were noted . In patients , indexes of systolic and diastolic function and interventricular septal thickness were similar to control values . The mean LVMi was normal in both groups . However , the mean LVMi in patients ( 117 + /- 35 g/m2 ) was higher than that in controls ( 92 + /- 31 ; P < 0.05 ) . In conclusion , patients were minimally affected by TSH-suppressive doses of T4 . They had few symptoms and no increase in extrasystoles or basal heart rate . Based on current knowledge , the increase in LVMi observed in patients without associated significant systolic or diastolic abnormalities does not have clinical or prognostic importance . Therefore , in the absence of symptoms of thyrotoxicosis , patients treated with TSH-suppressive doses of L-T4 may be followed clinical ly without specific cardiac laboratory studies CONTEXT Previous studies of the effects of levothyroxine ( LT(4 ) ) therapy on bone and bone metabolism have provided conflicting results . OBJECTIVE This study evaluated the potential effects and dose-response relationship of LT(4 ) therapy on bone mineral density ( BMD ) as well as bone and muscle strength . DESIGN AND SETTING We conducted a prospect i ve , nonr and omized , controlled cohort study with 1.1 ± 0.2-yr follow-up at an academic outpatient clinic in Germany . PARTICIPANTS Ninety-seven men and premenopausal women were enrolled in the study after thyroidectomy and radioiodine remnant ablation for well-differentiated thyroid carcinoma ( DTC ) or strumectomy for nontoxic goiter . Patients were matched with 89 healthy controls . INTERVENTIONS Twenty-eight men and 46 women on TSH-suppressive doses of LT(4 ) had DTC , and 23 women were on LT(4 ) replacement therapy for nontoxic goiter . MAIN OUTCOME MEASURE This study assessed total and trabecular volumetric BMD ( vBMD ) as well as bone strength at the ultradistal radius , areal BMD at the lumbar spine and both hips , and the grip strength of the nondominant forearm . The dependent variables were annualized rates of change . RESULTS LT(4 ) therapy did not impair the areal BMD , bone strength , or grip strength of patients compared with controls . Women with DTC showed a significant loss of total vBMD , whereas men with DTC developed marginally less bone strength than women . Carboxy-terminal telopeptide indicated greater bone resorption in DTC patients compared with controls . CONCLUSIONS There was little evidence of adverse LT(4 ) effects on bone ; however , premenopausal women with DTC might be at risk for reduced vBMD in their ultradistal radii Data on co-morbidity in patients with postsurgical hypoparathyroidism ( HypoPT ) are sparse . We aim ed to assess risk of fractures , spinal stenosis , cataract , neuropsychiatric diseases , cancer , and infections within the historic cohort of patients with postsurgical HypoPT due to non-malignant causes that we previously have characterized . Patients were identified through the Danish National Patient Registry and regional prescription data bases , with subsequent validation of their individual hospital records . Identified cases were matched with three age- ( ± 2 yr ) and gender-matched controls from the general background population . Compared with controls , patients did not have an increased risk of cataract ( p = 0.52 ) , spinal stenosis ( p = 0.59 ) , or any fracture ( p = 0.98 ) . However , the risk of fractures at the upper extremities was significantly decreased in patients ( HR 0.69 , 95 % CI 0.49 - 0.97 ) . Compared with controls , patients had a significantly increased risk of hospitalization due to infections ( HR 1.42 , 95 % CI 1.20 - 1.67 ) and depression/bipolar affective disorders ( HR 1.99 , 95 % CI 1.14 - 3.46 ) . The risk of malignant diseases did not differ between groups although the risk of gastrointestinal cancers was significantly lower in patients compared with controls ( HR 0.63 , 95 % CI 0.44 - 0.93 ) . In conclusion , HypoPT is associated with an increased risk of depression and other types of neuropsychiatric diseases as well as infections , whereas patients seem to be protected against fractures at the upper extremities and gastrointestinal malignancies OBJECTIVE To evaluate if a supervised exercise training program improves the quality of life ( QoL ) of differentiated thyroid carcinoma ( DTC ) patients on TSH-suppressive therapy with levothyroxine ( L-T4 ) . SUBJECTS AND METHODS Initially , a cross-sectional study was performed to compare the QoL and the health-related quality of life ( HRQoL ) between sub clinical hyperthyroidism ( SCH ) patients ( n = 33 ) and euthyroid subjects ( EU ; n = 49 ) . In the prospect i ve phase of the study , SCH patients were r and omized in a non-blinded fashion to either participate ( SCH-Tr = trained patients ; n = 16 ) or not ( SCH-Sed = untrained patients ; n = 17 ) in a supervised exercise training program . The exercise program consisted of 60 minutes of aerobic and stretching exercises , twice a week , during twelve weeks . The QoL was assessed by the application of the WHOQOL-Bref , and the SF-36 was used to assess the HRQoL. RESULTS SCH patients had statistically lower scores than EU on the " physical " domain of WHOQOL-Bref , besides " physical function " , " role-physical " , " bodily pain " , " general health " , " vitality " , " role-emotional " , and " mental-health " domains of SF-36 . After three months , SCH-Tr patients showed improvement in the " physical " and " psychological " domains of WHOQOL-Bref ( p < 0.05 ) , and in the " physical function " , " role-physical " , " bodily pain " , " vitality " and " mental health " domains of SF-36 . CONCLUSION Patients on TSH-suppressive therapy with L-T4 for DTC had impaired QoL and HRQoL compared to EU , but it was improved after 3-months of an exercise training program . Exercise seems to play an important role in the follow-up of DTC patients , since it seems to minimize the adverse effects of the treatment on QoL and To determine the effect of suppressive doses of thyroxine ( T4 ) on bone mass , we studied 50 women on suppressive doses of T4 for 3 - 27 years ( mean of 11 years ) . Twenty-five had nontoxic goiter and 25 had well-differentiated thyroid carcinoma . Fifty controls were matched for age , menopausal status , and body mass index . Bone mineral density ( BMD ) was measured in the lumbar spine ( LS ) , femoral neck ( FN ) , trunk ( TK ) , and extremities ( EXT ) by dual-energy X-ray absorptiometry ( DXA ) . In addition , the trunk area was measured by neutron activation analysis and recorded as a calcium bone index ( CaBI ) . Twenty-one patients were restudied with DXA measurements at a mean of 1.5 + /- 0.5 ( 1 SD ) years . The total population of 50 patients showed no difference in bone mass from controls . In patients with nontoxic goiter , there was no evidence of any loss in bone mass . Cancer patients showed insignificant reductions of 2 - 5 % in BMD of LS , FN , and TK and a significant 5 % reduction in BMD of EXT , compared to controls , and a 12 % reduction in CaBI compared to goiter patients . Cancer patients had a slightly higher ( p < 0.001 ) mean daily dose of T4 than goiter patients ( 0.23 vs 0.15 mg/day ) but had a similar degree of TSH suppression . BMD and CaBI values did not correlate with free T4 index ) with the daily T4 dose , accumulative dose , or with duration of T4 therapy . There were no significant changes in bone mass in either goiter or cancer patients restudied after a mean of 1.5 years . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND The influence of thyrotropin ( thyroid-stimulating hormone [ TSH ] ) suppressive therapy on bone mineral density ( BMD ) remains contentious . We have conducted a r and omized controlled trial evaluating the effects of postoperative TSH suppressive therapy on disease-free survival for papillary thyroid carcinoma ( PTC ) since 1996 , while prospect ively verifying the effects of TSH suppression on BMD . METHODS Lumbar spine BMD as expressed by T-score was examined annually in female patients r and omly assigned to receive TSH suppressive therapy ( group A ; n = 144 ) or no therapy ( group B ; n = 127 ) . RESULTS The mean TSH level was 0.07 ± 0.10 mU/L in group A and 3.14 ± 1.69 mU/L in group B. Group B did not show any significant decrease in T-score until 5 years postoperatively , whereas group A had a significant deterioration from 1 year postoperatively . Among group A patients , significant decreases in T-score within 1 year were seen in patients ≥ 50 years of age , but not in those < 50 years of age . After 5 years of TSH suppression , 20 patients had T-scores below -2.0 and 100 patients did not . These former patients were significantly older and had lower preoperative BMD measurements than the latter . CONCLUSION This prospect i ve controlled trial suggests that TSH suppression after surgery for PTC has adverse effects on BMD in women ≥ 50 years of age OBJECTIVE To address the influence of thyroid hormones on circulating markers of cell-mediated immune response in an in vivo human model . SUBJECTS AND DESIGN Twenty-two patients with stage I differentiated thyroid carcinoma were studied on the last day of thyroxine suppressive treatment , 4 - 7 days after withdrawal , and the day before whole body scanning . Three patients were excluded because of residual disease . Twenty euthyroid individuals served as controls . Serum thyrotrophin and thyroid hormones were measured by an immunometric assay , circulating cytokines by enzyme-linked immuno-sorbent assay and lymphoid population s by flow cytometry . RESULTS Thyroid function in patients changed from sub clinical or mild hyperthyroidism at the first visit , to a situation of normal circulating levels of free thyroxine and triiodothyronine at the second , ending in a state of overt hypothyroidism . Thyroxine suppressive treatment in patients increased serum interleukin-18 concentrations ( IL-18 , mean+/-s.d . , 280+/-122 vs 183+/-106 pg/ml , F = 3.192 , P = 0.029 ) , soluble interleukin-2 receptor levels ( sIL-2R , 4368+/-1480 vs 2564+/-846 pg/ml , F = 21.324 , P < 0.001 ) , and the percentage of natural killer ( NK ) cells in peripheral blood ( 15.9+/-8.6 vs 10.5+/-3.6 % , F = 4.977 , P = 0.004 ) compared with controls . After thyroxine withdrawal , serum levels of IL-18 , sIL-2R and the percentage of NK cells decreased progressively . CONCLUSION Our present results suggest that thyroid hormones modulate the cell-mediated immune response in humans Abstract . This study was carried out in order to investigate the possible detrimental effects on bone of levothyroxine ( l-T4 ) suppressive therapy in female patients who had undergone surg
Output:
| Skeletal effects were more marked in postmenopausal women .
There was no evidence of increased fracture risk , and only little data were available on hypoparathyroidism .
There was little difference in basic physiological parameters and limited literature regarding symptoms or significant events .
Impaired glucose metabolism and prothrombotic states were also found in DTC patients .
CONCLUSION There is limited literature regarding long-term DTC treatment-related morbidity , particularly regarding the effects of long-term hypocalcemia . |
MS211825 | ***TASK*** the task is to summarize an input biomedical literature 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: Supportive social relationships , including a positive patient-practitioner relationship , have been associated with positive health outcomes . Using the data from a r and omized controlled trial ( RCT ) undertaken in the Boston area of the United States , this study sought to identify baseline factors predictive of patients ' response to an experimentally applied supportive patient-practitioner relationship . To sort through the hundreds of potential attributes affecting the patient-practitioner relationship , we applied a false discovery rate method borrowed from the field of genomics and bioinformatics . To our knowledge such a method has not previously been applied to generate hypotheses from clinical trial data . In a previous RCT , our team investigated the effect of the patient-practitioner relationship on symptom improvement in patients with irritable Bowel syndrome ( IBS ) . Data were collected on a sample of 289 individuals with IBS using a three-week , single blind , three arm , r and omized controlled design . We found that a supportive patient-practitioner relationship significantly improved symptomatology and quality of life . A complex , multi-level measurement package was used to prospect ively measure change and identify factors associated with improvement . Using a local false discovery rate procedure , we examined the association of 452 baseline subject variables with sensitivity to treatment . Out of 452 variables , only two baseline factors , reclusiveness , and previous trial experience increased sensitivity to the supportive patient-practitioner relationship . A third variable , additional opportunity during the study for subjects to discuss their illness through experiential interview , was associated with improved outcomes among subjects who did not receive the supportive patient-practitioner relationship . The few variables associated with differential benefit suggest that a patient-centered supportive patient-practitioner relationship may be beneficial for most patients . This may be especially important for reclusive individuals . Within the context of our study , additional study attention in the form of repeated experiential interviews compensated for a lack of positive patient-practitioner support . A supportive patient-practitioner relationship may also help overcome low provider expectations for subjects with previous trial experience . These results converge with the results of the parent trial , implicating the importance of the social world in healing Background It is an inherent assumption in r and omised controlled trials that the drug effect can be estimated by subtracting the response during placebo from the response during active drug treatment . Objective To test the assumption of additivity . The primary hypothesis was that the total treatment effect is smaller than the sum of the drug effect and the placebo effect . The secondary hypothesis was that non-additivity was most pronounced in participants with large placebo effects . Methods We used a within-subject r and omised blinded balanced placebo design and included 48 healthy volunteers ( 50 % males ) , mean ( SD ) age 23.4 ( 6.2 ) years . Experimental pain was induced by injections of hypertonic saline into the masseter muscle . Participants received four injections with hypertonic saline along with lidocaine or matching placebo in r and omised order : A : received hypertonic saline/told hypertonic saline ; B : received hypertonic saline+lidocaine/told hypertonic saline ; C : received hypertonic saline+placebo/told hypertonic saline+pain killer ; D : received hypertonic saline+lidocaine/told hypertonic saline+pain killer . The primary outcome measure was the area under the curve ( AUC , mm2 ) of pain intensity during injections . Results There was a significant difference between the sum of the drug effect and the placebo effect ( mean AUC 6279 mm2 ( 95 % CI , 4936–7622 ) ) and the total treatment effect ( mean AUC 5455 mm2 ( 95 % CI , 4585–6324 ) ) ( P = 0.049 ) . This difference was larger for participants with large versus small placebo effects ( P = 0.015 ) , and the difference correlated significantly with the size of the placebo effect ( r = 0.65 , P = 0.006 ) . Conclusion Although this study examined placebo effects and not the whole placebo response as in r and omised controlled trials , it does suggest that the additivity assumption may be incorrect , and that the estimated drug effects in r and omised controlled trials may be underestimated , particularly in studies reporting large placebo responses . The implication s for r and omised controlled trials and systematic review s need to be discussed BACKGROUND Depression is frequently found in patients with age-related macular degeneration ( AMD ) . The purpose of this study was to assess the effectiveness of escitalopram in treating major and minor depression in AMD patients . METHODS We conducted a crossover , r and omized , double-blind , placebo-controlled , 16-week study comparing escitalopram with placebo . Inclusion criteria included reduced vision from AMD and major or minor depression , with a 17-item Hamilton Rating Scale for Depression ( HAMD-17 ) score of ≥10 . Participants were r and omly assigned to receive either escitalopram or placebo for 8 weeks and then crossed over to the other treatment . The primary outcome was change on the total HAMD-17 score with escitalopram treatment compared with placebo . RESULTS We enrolled 16 AMD patients ( mean age 79.1 ) , 12 with major depression and 4 with minor depression . Mean HAMD-17 score at enrollment was 16.1 ± 4.2 , and mean visual acuity in the better eye was 20/70 . During escitalopram treatment , participants showed a significant reduction in HAMD-17 scores compared with placebo treatment ( P = .01 ) . CONCLUSIONS These findings suggest escitalopram may be an effective treatment for depressive symptoms associated with major or minor depression in AMD patients with vision loss OBJECTIVE The present study examined the efficacy and tolerability of acute escitalopram treatment in depressed patients aged 60 years or older . METHODS Patients aged > or = 60 years with Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition major depressive disorder were r and omized to 12 weeks of double-blind , flexible-dose treatment with escitalopram ( 10 - 20 mg/day ; N = 130 ) or placebo ( N = 134 ) . The prospect ively defined primary efficacy end point was change from baseline to week 12 in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score using the last observation carried forward approach . RESULTS A total of 109 ( 81 % ) patients in the placebo group and 96 ( 74 % ) patients in the escitalopram group completed treatment . Mean age in both groups was approximately 68 years . Mean baseline MADRS scores were 28.4 and 29.4 for the placebo and escitalopram treatment groups , respectively . Escitalopram did not achieve statistical significance compared with placebo in change from baseline on the MADRS ( least square mean difference : -1.34 ; last observation carried forward ) . Discontinuation rates result ing from adverse events were 6 % for placebo and 11 % for escitalopram . Treatment-emergent adverse events reported by > 10 % of patients in the escitalopram group were headache , nausea , diarrhea , and dry mouth . CONCLUSIONS Escitalopram treatment was not significantly different from placebo treatment on the primary efficacy measure , change from baseline to week 12 in MADRS . In patients aged 60 years or older with major depression , acute escitalopram treatment appeared to be well tolerated The purpose of this study was to compare the effects of 16 weeks of a comprehensive exercise routine to supervised walking and social conversation on depression in nursing home residents with Alzheimer 's disease ( AD ) . Method : This study was a three-group , repeated- measures design with r and om assignment to treatment group . Forty-five nursing home residents with moderate to severe AD were r and omly assigned to a 16-week programme of comprehensive exercise , supervised walking or social conversation . Raters were blinded to treatment group assignment . Major outcome variables were depression measured by the Cornell Scale for Depression in Dementia , mood measured by the Dementia Mood Assessment Scale and the Alzheimer 's Mood Scale , and affect measured by the Observed Affect Scale . Depression was reduced in all three groups with some evidence of superior benefit from exercise . Depression is a common problem with serious and costly consequences for nursing home residents with AD . Exercise as a behavioural approach to treatment of depression in nursing home residents with severe AD evidence d a clear benefit to participants in this study . More research is needed to clarify the relative benefits of different types of exercise in conjunction with or without pharmacological intervention The logic of the r and omized double-blind placebo control group design is presented , and problems with using the design in psychotherapy are discussed . Placebo effects are estimated by examining clinical trials in medicine and psychotherapy . In medicine , a recent meta- analysis of clinical trials with treatment , placebo , and no treatment arms was conducted ( Hróbjartsson & Gøtzsche , 2001 ) , and it was concluded that placebos have small or no effects . A re- analysis of those studies , presented here , shows that when disorders are amenable to placebos and the design is adequate to detect the effects , the placebo effect is robust and approaches the treatment effect . For psychological disorders , particularly depression , it has been shown that pill placebos are nearly as effective as active medications whereas psychotherapies are more effective than psychological placebos . However , it is shown that when properly design ed , psychological placebos are as effective as accepted psychotherapies BACKGROUND Pill-taking , expectations and therapeutic alliance may account for much of the benefit of medication and placebo treatment for major depressive disorder ( MDD ) . Aims To examine the effects of medication , placebo and supportive care on treatment outcome , and the relationships of expectations and therapeutic alliance to improvement . METHOD A total of 88 participants were r and omised to 8 weeks of treatment with supportive care alone or combined with double-blind treatment with placebo or antidepressant medication . Expectations of medication effectiveness , general treatment effectiveness and therapeutic alliance were measured ( trial registration at Clinical Trials.gov : NCT00200902 ) . RESULTS Medication or placebo plus supportive care were not significantly different but had significantly better outcome than supportive care alone . Therapeutic alliance predicted response to medication and placebo ; expectations of medication effectiveness at enrolment predicted only placebo response . CONCLUSIONS Pill treatment yielded better outcome than supportive care alone . Medication expectations uniquely predicted placebo treatment outcome and were formed by time of enrolment , suggesting that they were shaped by prior experiences outside the clinical trial A previously tested theoretical model that specifies relationships among depression , activities of daily living ( ADL ) impairment , and social support components was vali date d with 307 patients aged 60 and older from a multisite effectiveness trial of 3 treatments ( antidepressant , placebo , Problem-Solving Treatment ) for dysthymia or minor depression in primary care . Participants completed interviews and self-reports at baseline and at 6 and 12 weeks . The short-term , longitudinal data were analyzed with covariance structure modeling techniques . Consistent with the previous model , impairment in ADLs was associated with subsequent increases in depression , a larger emotionally close network that made frequent visits was associated with subsequent increases in perceived support , and perceived support was associated with subsequent decreases in depression . This last effect was significant only among participants r and omly assigned to receive placebo with clinical management . The similar results in 2 different studies are a substantial validation of the theoretical model . The effect of perceived support primarily in the placebo group suggests that those with greater perceived social support and subsyndromal depression may be more likely to have a positive response to nonspecific clinical treatment components CONTEXT Insufficient evidence exists for recommendation of specific effective treatments for older primary care patients with minor depression or dysthymia . OBJECTIVE To compare the effectiveness of pharmacotherapy and psychotherapy in primary care setting s among older persons with minor depression or dysthymia . DESIGN R and omized , placebo-controlled trial ( November 1995-August 1998 ) . SETTING Four geographically and clinical ly diverse primary care practice s. PARTICIPANTS A total of 415 primary care patients ( mean age , 71 years ) with minor depression ( n = 204 ) or dysthymia ( n = 211 ) and a Hamilton Depression Rating Scale ( HDRS ) score of at least 10 were r and omized ; 311 ( 74.9 % ) completed all study visits . INTERVENTIONS Patients were r and omly assigned to receive paroxetine ( n = 137 ) or placebo ( n = 140 ) , starting at 10 mg/d and titrated to a maximum of 40 mg/d , or problem-solving treatment- primary care ( PST-PC ; n = 138 ) . For the paroxetine and placebo groups , the 6 visits over 11 weeks included general support and symptom and adverse effects monitoring ; for the PST-PC group , visits were for psychotherapy . MAIN OUTCOME MEASURES Depressive symptoms , by the 20-item Hopkins Symptom Checklist Depression Scale ( HSCL-D-20 ) and the HDRS ; and functional status , by the Medical Outcomes Study Short-Form 36 ( SF-36 ) physical and mental components . RESULTS Paroxetine patients showed greater ( difference in mean [ SE ] 11-week change in HSCL-D-20 scores , 0.21 [ 0 . 07 ] ; P = .004 ) symptom resolution than placebo patients . Patients treated with PST-PC did not show more improvement than placebo ( difference in mean [ SE ] change in HSCL-D-20 scores , 0.11 [ 0.13 ] ; P = .13 ) , but their symptoms improved more rapidly than those of placebo patients during the latter treatment weeks ( P = .01 ) . For dysthymia , par
Output:
| Baseline severity was not associated with an antidepressant-placebo difference and placebo responses are large in the treatment of depressed elderly people . |
MS211826 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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***EXAMPLES***
Input: BACKGROUND Little is known about the role of asymptomatic bacteriuria ( AB ) treatment in young women affected by recurrent urinary tract infection ( UTI ) . We aim ed to evaluate the impact of AB treatment on the recurrence rate among young women affected by recurrent UTI . METHODS A total of 673 consecutive asymptomatic young women with demonstrated bacteriuria from January 2005 to December 2009 were prospect ively enrolled . Patients were split into 2 groups : not treated ( group A , n = 312 ) and treated ( group B , n = 361 ) . Microbiological and clinical evaluations were performed at 3 , 6 , and 12 months . Quality of life was also measured . Recurrence-free rate at the end of the entire study period was the main outcome measure . RESULTS At baseline , the 2 most commonly isolated pathogens were Escherichia coli ( group A , 38.4 % ; group B , 39.3 % ) and Enterococcus faecalis ( group A , 32.7 % ; group B , 33.2 % ) . At the first follow-up visit , there was no difference between the 2 groups ( relative risk [ RR ] , 1.05 ; 95 % confidence interval [ CI ] , 1.01 - 1.10 ) , whereas after 6 months , 23 ( 7.6 % ) in group A and 98 ( 29.7 % ) in group B showed recurrence with a statistically significant difference ( RR , 1.31 ; 95 % CI , 1.21 - 1.42 ; P < .0001 ) . At the last follow-up , 41 ( 13.1 % ) in group A and 169 ( 46.8 % ) in group B showed recurrence ( RR , 3.17 ; 95 % CI , 2.55 - 3.90 ; P < .0001 ) . One patient in group A and 2 patients in group B were found to have pyelonephritis . CONCLUSIONS This study shows that AB should not be treated in young women affected by UTI , suggesting it may play a protective role in preventing symptomatic recurrence BACKGROUND Persistent Escherichia coli asymptomatic bacteriuria ( ASB ) is common among persons with diabetes mellitus , but the duration of colonization and the rates of recolonization are unknown . We estimated the duration of colonization and the rate of recolonization among successively isolated E. coli from diabetic women with ASB and compared the virulence profiles with uropathogenic and commensal E. coli . METHODS A total of 105 women with diabetes were enrolled in a r and omized , controlled clinical trial for treatment of ASB in Manitoba , Canada , and were observed at least every 3 months for up to 3 years . We analyzed 517 isolates from 70 women with repeated E. coli ASB for genetic similarity using enterobacterial repetitive intergenic consensus polymerase chain reaction . Unique strains were screened for uropathogenic virulence characteristics using dot blot hybridization and compared with different collection s of E. coli isolates . RESULTS On average , differences were found among women assigned to treatment for ASB , those treated only for symptomatic infections , and untreated women in ( 1 ) follow-up time with bacteriuria ( 29 % , 31 % , and 66 % , respectively ; P<.001 ) , ( 2 ) duration of bacteriuria ( 2.2 , 2.5 , and 3.7 months , respectively ; P=.04 ) , and ( 3 ) carriage of unique isolates ( 2.4 , 2.8 , and 4 months , respectively ; P=.03 ) . Women assigned to antibiotic treatment usually had recurrent infection ( 76 % ) , 64 % of the time with a genetically new E. coli strain . Virulence characteristics of these isolates were comparable to those of fecal isolates from healthy women . CONCLUSIONS Treatment may reduce the overall proportion of time infected in the long term and carriage of a unique strain , but most treatment regimens were followed by subsequent recolonization . Infecting strains did not have virulence factors characteristic of uropathogenic E. coli This prospect i ve r and omized study was undertaken to determine the efficacy of antimicrobial therapy compared with no therapy for bacteriuria in elderly ambulatory nonhospitalized women . Sixty-one women ( mean age , 85.8 years ) with bacteriuria were in the no therapy control group and 63 women ( mean age , 85.8 years ) with bacteriuria were in the therapy group ; none had symptoms of urinary tract infection . One short course of antimicrobial therapy achieved a cure rate of 68.3 % ( 43 of 63 women cured ) two weeks after treatment . During the six-month follow-up period , ten ( 16.4 % ) of 61 women in the no therapy group and five ( 7.9 % ) of 63 women in the therapy group developed symptomatic urinary tract infection . At the time of six-month follow-up , 19 ( 34.5 % ) of 55 women in the no therapy group and 35 ( 63.6 % ) of 55 women in the therapy group did not have bacteriuria . We conclude that for asymptomatic bacteriuria in elderly ambulatory nonhospitalized women , short-course antimicrobial therapy is effective at two-week follow-up and that antimicrobial therapy can eliminate bacteriuria in most of these women for at least a six-month period OBJECTIVE To determine whether treatment of symptomatic bacteriuria in older ambulatory women affects the subsequent development of symptoms of urinary tract infection . DESIGN A controlled clinical trial . PARTICIPANTS Older women not having urinary catheters . MEASUREMENTS Urine cultures every 6 months ( the same organism at 10(5 ) colony-forming units or more per mL on two midstream urine specimens defined asymptomatic bacteriuria ) and question naire surveys for the new development of symptoms of urinary tract infection ( dysuria , frequency , urgency , low back pain with fever ) 1 , 3 , and 6 months after the initial survey . RESULTS Of the 23 initially culture-positive participants receiving antibiotic treatment for symptomatic bacteriuria , nine were culture positive at 6 months , which contrasts with 18 of 27 who received no treatment or placebo , P = .05 . However , symptoms of urinary tract infection were more common in the antibiotic-treated group . CONCLUSION Antibiotic therapy effectively reduced the subsequent occurrence of positive urine cultures , but symptoms were not reduced . Based on this study of morbidity , previous studies failing to show any relation to mortality , and the cost and complications of antibiotic therapy in the older population , treatment of asymptomatic bacteriuria in older women is contraindicated Fifty elderly ( mean age , 83.4 + /- 8.8 years ) institutionalized women with asymptomatic bacteriuria were r and omly assigned either to receive therapy for treatment of all episodes of bacteriuria identified on monthly culture or to receive no therapy unless symptoms developed . Subjects were followed for one year . The therapy group had a mean monthly prevalence of bacteriuria 31 + /- 15 percent lower than those in the no-therapy group , but periods free of bacteriuria lasting six months or longer were documented for only five ( 24 percent ) subjects . For residents receiving no therapy , 71 percent showed persistent infection with the same organism(s ) . Antimicrobial therapy was associated with an increased incidence of reinfection ( 1.67 versus 0.87 per patient-year ) and adverse antimicrobial drug effects ( 0.51 versus 0.046 per patient-year ) as well as isolation of increasingly resistant organisms in recurrent infection when compared with no therapy . No differences in genitourinary morbidity or mortality were observed between the groups . Thus , despite a lowered prevalence of bacteriuria , no short-term benefits were identified and some harmful effects were observed with treatment of asymptomatic bacteriuria . These data support current recommendations of no therapy for asymptomatic bacteriuria in this population Abstract . Background : The objective of this study was to examine the expression of Escherichia coli virulence-associated factors among the strains isolated from a group of women with a history of recurrent urinary tract infections ( UTIs ) , in whom asymptomatic bacteriuria ( ABU ) was detected at follow-up , and from a group of children without a history of previous UTI , in whom ABU was detected during the screening . Possible differences between the virulence potential of these strains were investigated . Material s and Methods : Hemolysin production , the ability to adhere to Buffalo green monkey cell line and hemagglutination ( HA ) ability of the ABU-associated E. coli strains were tested . E. coli strains isolated from patients with acute recurrent UTIs served as a comparison . Results : The well-known low virulence of strains isolated from patients with ABU was demonstrated . In contrast to strains isolated from recurrent uncomplicated UTIs , the ABU-associated strains were mostly nonhemolytic ( 75 % ) , nonadherent ( 70 % ) and lacked HA ability ( 61 % ) . HA ability was significantly more common among the strains isolated from children without a history of UTI than among the strains isolated from women with recurrent UTIs ( χ2 = 9.97 , p < 0.01 ) , whereas the adherence and hemolytic abilities did not differ between the two ABU groups . Conclusion : A further prospect i ve study is needed to determine whether the HA ability is the predictor of subsequent symptomatic UTI In a prospect i ve longitudinal study , ambulatory elderly men were followed from 1 to 4.5 years to gain insight into the prevalence rates , clinical characteristics , and patterns of clinical ly inapparent ( asymptomatic ) bacteriuria ( CIB ) . The prevalence of CIB was 12 % ( 29/238 ) and increases with age . Unlike the gram-negative organisms that cause overt urinary tract infection in this age group , gram-positive organisms dominated the CIB group . Both the CIB and abacteriuric patients have multiple chronic medical conditions and are indistinguishable on that basis . Twenty-nine elderly men with bacteriuria and 105 abacteriuric subjects were followed with serial urine cultures . During the study period the bacteriuric subjects exhibited spontaneous temporary or permanent resolution ( 76 % , 22/29 ) , intermittency ( 21 % , 6/29 ) , and probable bacterial persistence ( 38 % , 11/29 ) . No consistent pattern of bacteriuria was evident . Therefore , antimicrobial therapy is not warranted in the treatment of asymptomatic or clinical ly inapparent bacteriuria in ambulatory elderly men Asymptomatic bacteriuria , a common problem of the elderly , has been associated with increased mortality in the elderly [ 1 - 4 ] , although not all studies have confirmed this finding [ 5 - 9 ] . To reconcile these conflicting results , we did a longitudinal study of urinary tract infection in ambulatory elderly women to evaluate the putative relation between asymptomatic bacteriuria and mortality . We considered resolution of this issue to be important because of the implication s for clinical practice . If asymptomatic bacteriuria were shown to be an independent risk factor for mortality and if it could also be shown that eradication of the infection by antimicrobial therapy decreased the risk for death , then screening and antimicrobial treatment of elderly ambulatory women with asymptomatic bacteriuria might be warranted and the cost of identifying and treating such infections might be justified . Conversely , failure to confirm a relation would support the view that programs to screen for bacteriuria would not be justified if their goal was to enhance survival . This report summarizes the findings of our 9-year study to determine whether asymptomatic bacteriuria in elderly ambulatory women is a marker of increased mortality and , if so , whether it is because of an association with other determinants of mortality or because asymptomatic bacteriuria is itself an independent cause , the removal of which might improve longevity . The components of the study were a longitudinal study in elderly ambulatory women to compare mortality in those with and without asymptomatic bacteriuria and a double-blind , controlled clinical trial in which antimicrobial therapy was administered for asymptomatic bacteriuria to assess whether treatment decreases mortality . Methods Participant enrollment and the participating institutions have been described previously [ 10 , 11 ] . Elderly ambulatory residents of the Philadelphia Geriatric Center and of 21 continuing care retirement communities in the greater Philadelphia metropolitan area who gave informed consent were enrolled in this long-term study of urinary tract infection in the elderly . Enrollment continued throughout the course of the study . Philadelphia Geriatric Center houses about 1000 residents who primarily are Jewish ; incomes are higher than the maximum Social Security payment ; and congregate living is provided either in an apartment house or in a nursing home . In contrast , the continuing care retirement communities are smaller ( bed size range , 108 to 675 ) ; incomes are higher ; residents are primarily not Jewish ; and a higher proportion of residents are fully independent . All female residents were eligible to participate except those with indwelling catheters or those incapable of providing midstream clean-catch urine specimens for culture . Specimens were obtained on enrollment and every 6 months thereafter . The protocol was approved by the appropriate institutional review boards , and informed consent was obtained from the participants or their surrogates . Table 1 shows the study periods and chronology of important study events . Throughout the study , urine cultures were obtained at about 6-month intervals . An observational study to compare mort
Output:
| No differences were observed between antibiotics versus no treatment of asymptomatic bacteriuria for the development of symptomatic UTI , complications or death .
Antibiotics were superior to no treatment for the bacteriological cure but with significantly more adverse events .
There was no clinical benefit from treating asymptomatic bacteriuria in the studies included in this review |
MS211827 | ***TASK*** the task is to summarize an input biomedical literature 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 Acute hemodynamic instability increases morbidity and mortality . We investigated whether early non-invasive cardiac output monitoring enhances hemodynamic stabilization and improves outcome . Methods A multicenter , r and omized controlled trial was conducted in three European university hospital intensive care units in 2006 and 2007 . A total of 388 hemodynamically unstable patients identified during their first six hours in the intensive care unit ( ICU ) were r and omized to receive either non-invasive cardiac output monitoring for 24 hrs ( minimally invasive cardiac output/MICO group ; n = 201 ) or usual care ( control group ; n = 187 ) . The main outcome measure was the proportion of patients achieving hemodynamic stability within six hours of starting the study . Results The number of hemodynamic instability criteria at baseline ( MICO group mean 2.0 ( SD 1.0 ) , control group 1.8 ( 1.0 ) ; P = .06 ) and severity of illness ( SAPS II score ; MICO group 48 ( 18 ) , control group 48 ( 15 ) ; P = .86 ) ) were similar . At 6 hrs , 45 patients ( 22 % ) in the MICO group and 52 patients ( 28 % ) in the control group were hemodynamically stable ( mean difference 5 % ; 95 % confidence interval of the difference -3 to 14 % ; P = .24 ) . Hemodynamic support with fluids and vasoactive drugs , and pulmonary artery catheter use ( MICO group : 19 % , control group : 26 % ; P = .11 ) were similar in the two groups . The median length of ICU stay was 2.0 ( interquartile range 1.2 to 4.6 ) days in the MICO group and 2.5 ( 1.1 to 5.0 ) days in the control group ( P = .38 ) . The hospital mortality was 26 % in the MICO group and 21 % in the control group ( P = .34 ) . Conclusions Minimally-invasive cardiac output monitoring added to usual care does not facilitate early hemodynamic stabilization in the ICU , nor does it alter the hemodynamic support or outcome . Our results emphasize the need to evaluate technologies used to measure stroke volume and cardiac output -- especially their impact on the process of care -- before any large-scale outcome studies are attempted . Trial Registration The study was registered at Clinical Trials.gov ( Clinical Trials identifier NCT00354211 BACKGROUND Some observational studies suggest that the use of pulmonary-artery catheters to guide therapy is associated with increased mortality . METHODS We performed a r and omized trial comparing goal -directed therapy guided by a pulmonary-artery catheter with st and ard care without the use of a pulmonary-artery catheter . The subjects were high-risk patients 60 years of age or older , with American Society of Anesthesiologists ( ASA ) class III or IV risk , who were scheduled for urgent or elective major surgery , followed by a stay in an intensive care unit . Outcomes were adjudicated by observers who were unaware of the treatment-group assignments . The primary outcome was in-hospital mortality from any cause . RESULTS Of 3803 eligible patients , 1994 ( 52.4 percent ) underwent r and omization . The base-line characteristics of the two treatment groups were similar . A total of 77 of 997 patients who underwent surgery without the use of a pulmonary-artery catheter ( 7.7 percent ) died in the hospital , as compared with 78 of 997 patients in whom a pulmonary-artery catheter was used ( 7.8 percent)--a difference of 0.1 percentage point ( 95 percent confidence interval , -2.3 to 2.5 ) . There was a higher rate of pulmonary embolism in the catheter group than in the st and ard-care group ( 8 events vs. 0 events , P=0.004 ) . The survival rates at 6 months among patients in the st and ard-care and catheter groups were 88.1 and 87.4 percent , respectively ( difference , -0.7 percentage point [ 95 percent confidence interval , -3.6 to 2.2 ] ; negative survival differences favor st and ard care ) ; at 12 months , the rates were 83.9 and 83.0 percent , respectively ( difference , -0.9 percentage point [ 95 percent confidence interval , -4.3 to 2.4 ] ) . The median hospital stay was 10 days in each group . CONCLUSIONS We found no benefit to therapy directed by pulmonary-artery catheter over st and ard care in elderly , high-risk surgical patients requiring intensive care Background : An individualized fluid optimization strategy , based on maximization of cardiac stroke volume ( SV ) with colloid boluses ( goal ‐directed therapy ) , improves outcome after surgery . Oesophageal Doppler ( OD ) is used for SV maximization in most r and omized studies , but evidence ‐based guidelines for the SV maximization procedure are lacking and variation in SV may influence the indication for fluid administration . We measured beat‐to‐beat OD SV before and after fluid optimization in order to estimate the number of heartbeats for which SV needs to be averaged to provide an acceptable accuracy for goal ‐directed therapy with this technology Background Major colorectal surgery usually requires a hospital stay of more than 12 days . Inadequate pain management , intestinal dysfunction and immobilisation are the main factors associated with delay in recovery . The present work assesses the short and medium term results achieved by an enhanced recovery program based on previously published protocol s. Methods This prospect i ve study , performed at 12 Spanish hospitals in 2008 and 2009 , involved 300 patients . All patients underwent elective colorectal resection for cancer following an enhanced recovery program . The main elements of this program were : preoperative advice , no colon preparation , provision of carbohydrate-rich drinks one day prior and on the morning of surgery , goal directed fluid administration , body temperature control during surgery , avoiding drainages and nasogastric tubes , early mobilisation , and the taking of oral fluids in the early postoperative period . Perioperative morbidity and mortality data were collected and the length of hospital stay and protocol compliance recorded . Results The median age of the patients was 68 years . Fifty-two % of the patients were women . The distribution of patients by ASA class was : I 10 % , II 50 % and III 40 % . Sixty-four % of interventions were laparoscopic ; 15 % required conversion to laparotomy . The majority of patients underwent sigmoidectomy or right hemicolectomy . The overall compliance to protocol was approximately 65 % , but varied widely in its different components . The median length of postoperative hospital stay was 6 days . Some 3 % of patients were readmitted to hospital after discharge ; some 7 % required repeat surgery during their initial hospitalisation or after readmission . The most common complications were surgical ( 24 % ) , followed by septic ( 11 % ) or other medical complications ( 10 % ) . Three patients ( 1 % ) died during follow-up . Some 31 % of patients suffered symptoms that delayed their discharge , the most common being vomiting or nausea ( 12 % ) , dyspnoea ( 7 % ) and fever ( 5 % ) . Conclusion The following of this enhanced recovery program posed no risk to patients in terms of morbidity , mortality and shortened the length of their hospital stay . Overall compliance to protocol was 65 % . The following of this program was of benefit to patients and reduces costs by shortening the length of hospital stay . The implantation of such programmes is therefore highly recommended Introduction Perioperative hypovolemia arises frequently and contributes to intestinal hypoperfusion and subsequent postoperative complications . Goal -directed fluid therapy might reduce these complications . The aim of this study was to compare the effects of goal -directed administration of crystalloids and colloids on the distribution of systemic , hepatosplanchnic , and microcirculatory ( small intestine ) blood flow after major abdominal surgery in a clinical ly relevant pig model . Methods Twenty-seven pigs were anesthetized and mechanically ventilated and underwent open laparotomy . They were r and omly assigned to one of three treatment groups : the restricted Ringer lactate ( R-RL ) group ( n = 9 ) received 3 mL/kg per hour of RL , the goal -directed RL ( GD-RL ) group ( n = 9 ) received 3 mL/kg per hour of RL and intermittent boluses of 250 mL of RL , and the goal -directed colloid ( GD-C ) group ( n = 9 ) received 3 mL/kg per hour of RL and boluses of 250 mL of 6 % hydroxyethyl starch ( 130/0.4 ) . The latter two groups received a bolus infusion when mixed venous oxygen saturation was below 60 % ( ' lockout ' time of 30 minutes ) . Regional blood flow was measured in the superior mesenteric artery and the celiac trunk . In the small bowel , microcirculatory blood flow was measured using laser Doppler flowmetry . Intestinal tissue oxygen tension was measured with intramural Clark-type electrodes . Results After 4 hours of treatment , arterial blood pressure , cardiac output , mesenteric artery flow , and mixed oxygen saturation were significantly higher in the GD-C and GD-RL groups than in the R-RL group . Microcirculatory flow in the intestinal mucosa increased by 50 % in the GD-C group but remained unchanged in the other two groups . Likewise , tissue oxygen tension in the intestine increased by 30 % in the GD-C group but remained unchanged in the GD-RL group and decreased by 18 % in the R-RL group . Mesenteric venous glucose concentrations were higher and lactate levels were lower in the GD-C group compared with the two crystalloid groups . Conclusions Goal -directed colloid administration markedly increased microcirculatory blood flow in the small intestine and intestinal tissue oxygen tension after abdominal surgery . In contrast , goal -directed crystalloid and restricted crystalloid administrations had no such effects . Additionally , mesenteric venous glucose and lactate concentrations suggest that intestinal cellular substrate levels were higher in the colloid-treated than in the crystalloid-treated animals . These results support the notion that perioperative goal -directed therapy with colloids might be beneficial during major abdominal surgery Introduction Little is known about mortality rates following general surgical procedures in the United Kingdom . Deaths are most common in the ' high-risk ' surgical population consisting mainly of older patients , with coexisting medical disease , who undergo major surgery . Only limited data are presently available to describe this population . The aim of the present study was to estimate the size of the high-risk general surgical population and to describe the outcome and intensive care unit ( ICU ) re source use . Methods Data on inpatient general surgical procedures and ICU admissions in 94 National Health Service hospitals between January 1999 and October 2004 were extracted from the Intensive Care National Audit & Research Centre data base and the CHKS data base . High-risk surgical procedures were defined prospect ively as those for which the mortality rate was 5 % or greater . Results There were 4,117,727 surgical procedures ; 2,893,432 were elective ( 12,704 deaths ; 0.44 % ) and 1,224,295 were emergencies ( 65,674 deaths ; 5.4 % ) . A high-risk population of 513,924 patients was identified ( 63,340 deaths ; 12.3 % ) , which accounted for 83.8 % of deaths but for only 12.5 % of procedures . This population had a prolonged hospital stay ( median , 16 days ; interquartile range , 9–29 days ) . There were 59,424 ICU admissions ( 11,398 deaths ; 19 % ) . Among admissions directly to the ICU following surgery , there were 31,633 elective admissions with 3,199 deaths ( 10.1 % ) and 24,764 emergency admissions with 7,084 deaths ( 28.6 % ) . The ICU stays were short ( median , 1.6 days ; interquartile range , 0.8–3.7 days ) but hospital admissions for those admitted to the ICU were prolonged ( median , 16 days ; interquartile range , 10–30 days ) . Among the ICU population , 40.8 % of deaths occurred after the initial discharge from the ICU . The highest mortality rate ( 39 % ) occurred in the population admitted to the ICU following initial postoperative care on a st and ard ward . Conclusion A large high-risk surgical population accounts for 12.5 % of surgical procedures but for more than 80 % of deaths . Despite high mortality rates , fewer than 15 % of these patients are admitted to the ICU OBJECTIVE To determine the effect of a community hospital-wide program enabling nurses and prehospital personnel to mobilize institutional re sources for the treatment of patients with nontraumatic shock . DESIGN Historically controlled single-center study . SETTING A 180-bed community hospital . PATIENTS Patients in shock who were c and i date s for aggressive therapy . INTERVENTIONS From January 1998 to May 31 , 2000 , patients in shock received st and ard therapy ( control group ) . During the month of June 2000 , intensive education of all health-care providers ( ie , pre
Output:
| Despite heterogeneity in trial quality and design , we found GDT to be beneficial in all high-risk patients undergoing major surgery .
The mortality benefit of GDT was confined to the subgroup of patients at extremely high risk of death .
The reduction of complication rates was seen across all subgroups of GDT patients |
MS211828 | ***TASK*** the task is to summarize an input biomedical literature 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: Atypical antipsychotics have been shown to improve disruptive and repetitive behaviors in pervasive developmental disorders ( PDDs ) , but they require assessment of potential side effects . This is the first placebo-controlled trial of olanzapine in the treatment of children and adolescents with PDD . Eleven patients with a diagnosis of either autism , Asperger 's syndrome , or PDD not otherwise specified ( PDD-NOS ) and aged 6 - 14 years were r and omized into an 8-week double-blind , placebo-controlled , parallel treatment study with olanzapine . There was a significant linear trend x group interaction on the Clinical Global Impressions- Improvement ( CGI-I ) and 50 % on olanzapine versus 20 % on placebo were responders . Olanzapine was associated with significant weight gain ( 7.5 + /- 4.8 lbs vs. 1.5 + /- 1.5 lbs on placebo ) . Olanzapine may be a promising treatment for improving global functioning of PDDs , but the risk of significant weight gain remains a concern . Additional studies are needed to determine the efficacy and safety of olanzapine in the treatment of children with PDD OBJECTIVE The authors studied weight gain mechanisms and energy balance in patients treated with olanzapine . METHOD The body mass index of male schizophrenic adolescent in patients treated with olanzapine ( N=10 ) and of 10 matched patients treated with haloperidol ( N=10 ) were measured at baseline and after 4 weeks of treatment . For the patients treated with olanzapine , caloric intake , resting energy expenditure , and physical activity ( determined through accelerometry and heart rate monitoring ) were assessed at baseline and after 4 weeks of treatment . RESULTS Body mass index significantly increased in those treated with olanzapine but not in those given haloperidol . The increase in body mass index was due to an increase in caloric intake without change in diet composition . Olanzapine had no significant effect on resting energy expenditure . Daily energy expenditure was very low before and after treatment . CONCLUSIONS Olanzapine-induced weight gain is associated with a general increase in caloric intake OBJECTIVE The purpose of this study was to evaluate the impact of prior antipsychotic exposure ( PAE ) on safety and tolerability outcomes in pediatric subjects receiving aripiprazole treatment . METHODS This study was a post-hoc analysis of pooled data from two 8-week , double-blind , r and omized , placebo-controlled studies evaluating aripiprazole for the treatment of irritability in pediatric subjects with autistic disorder , aged 6 - 17 years . Subjects were stratified by PAE ; adverse events ( AEs ) , and changes in weight , and metabolic measures were evaluated . For subjects receiving aripiprazole , regardless of PAE , baseline weight , age , gender , and symptom severity were evaluated in a regression model predicting body weight change . RESULTS Of 316 r and omized subjects , 259 ( 82.0 % ) were antipsychotic naïve ( AN ) and 57 ( 18.0 % ) had a PAE . Aripiprazole-treated AN subjects were more likely than PAE subjects to report somnolence ( 11.9 % vs. 2.8 % ) , sedation ( 22.7 % vs. 11.1 % ) , or fatigue ( 17.0 % vs. 13.9 % ) . Rates of extrapyramidal disorder and drooling , but not akathisia or tremor , were marginally higher in AN subjects . Overall , 10.8 % of aripiprazole-treated AN subjects had at least one AE leading to discontinuation compared with 8.3 % of aripiprazole-treated PAE subjects . AN subjects receiving aripiprazole had a larger change in weight from baseline to endpoint compared with those receiving placebo ( 1.9 vs. 0.7 kg ; treatment difference 1.2 kg , 95 % CI : 0.5 , 1.9 ) than PAE subjects receiving aripiprazole compared with subjects receiving placebo ( 0.4 vs. -0.4 kg ; treatment difference 0.9 kg , 95 % CI : -0.6 , 2.4 ) . Regression analysis identified that younger subjects with higher baseline weight z-score were at highest risk for weight gain . There were no significant changes in metabolic measures compared with placebo in either group . CONCLUSIONS Weight gain was more pronounced in AN subjects and more likely to occur in younger subjects with a higher baseline weight z-score . AN subjects were more likely to experience AEs related to somnolence . However , based on discontinuations rates from AEs , overall tolerability was good for both AN and PAE groups . CLINICAL TRIAL REGISTRATION Study of aripiprazole in the treatment of children and adolescents with autistic disorder . Registry : www . clinical trials.gov . Identifiers : NCT00332241 and NCT00337571 OBJECTIVE The purpose of this study was to evaluate the efficacy and safety of acute quetiapine monotherapy in adolescents with schizophrenia . METHODS Patients ages 13 - 17 years with an American Psychiatric Association , Diagnostic and Statistical Manual of Mental Disorders , 4th ed . , Text Revision ( DSM-IV-TR ) diagnosis of schizophrenia and a Positive and Negative Syndrome Scale ( PANSS ) total score ≥60 were r and omized to 6 weeks of quetiapine ( 400 or 800 mg/day ) or placebo treatment . The primary efficacy measure was change in PANSS total score from baseline to day 42 . Safety endpoints included adverse events and assessment s of clinical chemistry values , suicidality , and extrapyramidal symptoms . RESULTS The intent-to-treat population included 220 patients . Least-squares mean change in PANSS total score from baseline to endpoint was -27.31 with quetiapine 400 mg/day , -28.44 with quetiapine 800 mg/day , and -19.15 with placebo ( p=0.043 and 0.009 for quetiapine 400 and 800 mg/day , respectively , vs. placebo ; mixed-model , repeated- measures analysis ) . Several secondary efficacy outcomes , including Clinical Global Impressions-Improvement score , supported the primary outcome measure in demonstrating significantly greater improvement in quetiapine groups than in the placebo group . Mean changes in body weight at day 42 were 2.2 kg and 1.8 kg for quetiapine 400 and 800 mg/day , respectively , and -0.4 kg for placebo . Mean changes in certain clinical chemistry parameters , including total cholesterol and triglycerides , were numerically greater in the quetiapine groups than in the placebo group . Adverse events associated with quetiapine were mostly mild to moderate in intensity and were consistent with its known profile in adults with schizophrenia . CONCLUSIONS In this 6-week study of adolescent patients , quetiapine at doses of 400 and 800 mg/day provided significant improvements in symptoms associated with schizophrenia in adolescent patients , including the primary efficacy measure of PANSS total score change . Quetiapine was generally well tolerated with a profile broadly similar to that reported in adult and adolescent population s. CLINICAL TRIAL REGISTRATION INFORMATION Quetiapine Fumarate ( SEROQUEL ( ™ ) ) Compared to Placebo in the Treatment of Adolescent Patients With Schizophrenia ( ANCHOR 112 ) . Available at : http://www . clinical trials.gov/ct2/show/NCT00090324?term=quetiapine+112&rank=1 BACKGROUND Paliperidone extended-release ( ER ) is approved for treatment of schizophrenia in adults but has not been evaluated in adolescents . METHODS In this 6-week , double-blind , parallel-group study , participants ( n = 201 ) aged 12 to 17 years , with a Positive and Negative Syndrome Scale ( PANSS ) total score of 60 to 120 were r and omly allocated ( 1:1:1:1 ) to receive either placebo or one of three weight-based , fixed doses of paliperidone ER , once-daily ( patients weighing 29 to < 51 kg at baseline : 1.5 mg [ Low ] , 3 mg [ Medium ] , or 6 mg [ High ] ; patients weighing ≥ 51 kg : 1.5 mg [ Low ] , 6 mg [ Medium ] , or 12 mg [ High ] ) . RESULTS The mean ( SD ) change in PANSS total score from baseline to endpoint ( primary efficacy variable ) was significant for the paliperidone ER Medium-treatment ( -17.3 [ 14.33 ] ; p < .05 ; n = 54 ) but not for Low- ( -9.8 [ 16.31 ] ; n = 48 ) or High-treatment groups ( -13.8 [ 15.74 ] ; n = 47 ) versus placebo ( -7.9 [ 20.15 ] ; n = 51 ) . By actual dose , the mean ( SD ) change in PANSS total score was significant for the 3- , 6- , and 12-mg doses ( 3 mg : -19.0 [ 15.45 ] ) , 6 mg : -13.8 [ 14.75 ] , and 12 mg : -16.3 [ 15.41 ; ] all ps < .05 ) , compared with placebo ( -7.9 [ 20.15 ] ) . The total percentages of treatment-emergent adverse events were dose-related for the three weight-based treatment groups . CONCLUSIONS With weight-based treatment , only paliperidone ER Medium-treatment ( 3 - 6 mg ) result ed in significant improvement in symptoms of schizophrenia in adolescents , as did 3 , 6 , and 12 mg by actual dose strengths . Weight-based dosing of paliperidone ER in adolescents with schizophrenia does not appear to be necessary . Paliperidone ER ( 1.5 - 12 mg , once daily ) was tolerable , and no new safety concerns were reported BACKGROUND This study evaluates the long-term efficacy of aripiprazole compared to placebo in children with bipolar disorders . METHOD Out patients aged 4 to 9 years meeting DSM-IV criteria for a bipolar disorder ( I , II , not otherwise specified , cyclothymia ) were eligible to receive up to 16 weeks of open-label treatment with aripiprazole ( phase 1 ) . Patients were r and omized into the 72-week double-blind phase of the study once they met a priori response criteria for stabilization ( phase 2 ) . During phase 2 , patients either remained on their current aripiprazole regimen or began a double-blind taper with aripiprazole discontinued and switched to placebo . The primary outcome measure for phase 2 was time to discontinuation due to a mood event . RESULTS Patients were recruited between May 2004 and November 2008 . Following phase 1 , in which 96 patients received aripiprazole , 30 patients ( mean age = 7.1 years ) were r and omly assigned to continue aripiprazole and 30 patients ( mean age = 6.7 years ) were r and omly assigned to placebo . The mean ( SD ) dose of aripiprazole prior to r and omization for these patients was 6.4 ( 2.1 ) mg/d . Patients r and omly assigned to aripiprazole were enrolled significantly longer until time to study discontinuation due to a mood event ( 6.14 median weeks , SE ± 11.88 weeks ; P = .005 ) and discontinuation for any reason ( including mood events ) ( 4.00 median weeks , SE ± 3.91 weeks ; P = .003 ) than those r and omly assigned to placebo ( mood event , 2.29 median weeks , SE ± 0.38 weeks ; any reason , 2.00 median weeks , SE ± 0.31 weeks ) . Regardless of r and om assignment , both the aripiprazole and placebo groups showed substantial rates of withdrawal from maintenance treatment over the initial 4 weeks ( 15/30 [ 50 % ] for aripiprazole ; 27/30 [ 90 % ] for placebo ) , suggesting a possible nocebo effect ( ie , knowledge of possibly switching from active medication to placebo increasing concern about relapse ) . The most frequently reported adverse events during double-blind aripiprazole therapy included stomach pain ( n = 10 , 33 % ) , increased appetite ( n = 9 , 30 % ) , and headaches ( n = 9 , 30 % ) . CONCLUSIONS Despite the possibility of a nocebo effect , these results suggest that aripiprazole may be superior to placebo in the long-term treatment of pediatric patients following stabilization with open-label aripiprazole . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00194077 BACKGROUND & AIMS Weight gain is an undesirable side effect of second-generation antipsychotics ( SGAs ) . We performed this study to examine the influence of SGAs on resting energy expenditure ( REE ) and the relationship of REE to weight gain in adolescent patients . METHODS Antipsychotic-naïve or quasi-naïve ( < 72 h of exposure to antips
Output:
| FGAs caused slightly less weight gain and more extrapyramidal symptoms than SGAs .
SGAs as a class caused adverse effects , including weight gain , high triglyceride levels , extrapyramidal symptoms , sedation , and somnolence .
They appeared to increase the risk for high cholesterol levels and type 2 diabetes .
Olanzapine caused more short-term gains in weight and body mass index than several other SGAs .
The dose of SGAs may not make a difference over the short term for some outcomes . |
MS211829 | ***TASK*** the task is to summarize an input biomedical literature 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: & NA ; Transcutaneous electrical nerve stimulation ( TENS ) is a frequently applied therapy in chronic pain although evidence for effectiveness is inconclusive . Several types of TENS , based on different combinations of frequency , pulse duration and intensity , exist . The precise mechanism of action and the relevance of combinations of stimulus parameters are still unclear . To compare the effectiveness of three types of TENS we conducted a r and omized , single blinded crossover trial . Patients received two times a 2‐week period of daily TENS treatment , separated by a washout period of 2 weeks . In total , 180 chronic pain patients were r and omized into three groups . In group 1 , high frequency , low intensity TENS ( HFT ) was compared with high frequency , high intensity TENS ( HIT ) . In groups 2 and 3 , HFT and HIT were compared with a control TENS ( COT ) . The order of applying the different modalities of TENS in each group was also r and omized . Primary outcome was the patient 's overall assessment of effectiveness and pain reduction ( VAS ) . No differences were found in patient 's assessment or pain reducing effect between the three groups , indicating no superiority of one type of TENS . In total , 56 % continued TENS after the 2‐week treatment period . At 6 months , 42 % of all patients still used TENS . We concluded that there were no differences in effectiveness for the three types of TENS used in this study . Because no placebo group was included , no definite conclusions on effectiveness of TENS in general in the treatment of chronic pain could be made Objective : To investigate the hypoalgesic effects of transcutaneous electrical nerve stimulation ( TENS ) upon low back pain ( LBP ) in people with multiple sclerosis ( MS ) . Design : A r and omized double-blind placebo controlled clinical pilot study . Subjects and setting : Fifteen people with MS were recruited and r and omly allocated to one of the following groups under double blind conditions ( n = 5 per group ) : TENS 1 ( 4 Hz , 200 µs ) , TENS 2 ( 110 Hz , 200 µs ) , placebo TENS . Interventions : Treatment was applied for 45 minutes three times a week for six weeks with a four-week follow-up . Outcome measures : The following outcome measures were taken at weeks 1 , 6 , and 10 : visual analogue scale ( VAS ) ( for current LBP , right leg pain , left leg pain ) ; Leeds Multiple Sclerosis Quality of Life Question naire ; Rol and Morris Disability Question naire ; Short Form-36 ( SF-36 ) Version 1 ; and the McGill Pain Question naire ( MPQ ) . VAS for current LBP , right and left leg pain were also taken before and after treatment , and once a week during the follow-up period . Results : Analysis showed no statistically significant effects for any of the data . However , both active treatment groups showed a trend of improvement in the majority of the outcome measures . Conclusion : Active TENS was more effective than placebo TENS in decreasing VAS scores following each treatment although results were not statistically significant . Further work in this area is warranted and should include a larger number of participants in the form of a r and omized controlled clinical trial to determine the efficacy of this modality OBJECTIVES A preliminary examination of NMES and combined NMES/TENS for the management of chronic back pain . DESIGN Double-blind , placebo-controlled , r and omized repeated measures . SUBJECTS AND SETTING Consecutive sample of 24 chronic back pain patients ( 16 women and 8 men ) attending an outpatient pain clinic ( mean age 51.67 years , mean pain duration 3.83 years ) . All treatments were administered at home . INTERVENTIONS Subjects self-administered NMES , combined NMES/TENS , TENS , and placebo treatments . Each treatment had a duration of 5 consecutive hours per day over 2 consecutive days , with a 2-day hiatus between treatments to minimize carryover effects . MAIN OUTCOME MEASURES Pain reduction was assessed through pretreatment to posttreatment differences on the Present Pain Intensity ( PPI ) scale , and a visual analogue scale of Pain Intensity ( VAS-I ) . Posttreatment pain relief was assessed using a visual analogue scale of Pain Relief ( VAS-R ) . RESULTS Combined treatment , NMES , and TENS each produced significant pretreatment to posttreatment reductions in pain intensity as measured by both the PPI and VAS-I ( p < .05 ) . Combined treatment was superior to placebo on pain reduction ( p = .001 , p = .016 ) as well as pain relief ( p < .001 ) . Combined treatment was also superior to both TENS and NMES for pain reduction and pain relief ( p < .01 ) . NMES and TENS were superior only to placebo for pain relief ( p < .001 ) . CONCLUSIONS Combined NMES/TENS treatment consistently produced greater pain reduction and pain relief than placebo , TENS , or NMES . NMES alone , although less effective , did produce as much pain relief as TENS . Although preliminary , this pattern of results suggests that combined NMES/TENS may be a valuable adjunct in the management of chronic back pain . Further research investigating the effectiveness of both NMES and combined NMES/TENS seems warranted Objective This study was design ed to investigate the hypoalgesic effects of self-applied transcutaneous electrical nerve stimulation ( TENS ) on chronic low-back pain ( LBP ) in a multiple sclerosis ( MS ) population . Methods Ninety participants with probable or definite MS ( aged 21 to 78 y ) presenting with chronic LBP were recruited and r and omized into 3 groups ( n=30 per group ) : ( 1 ) low-frequency TENS group ( 4 Hz , 200 μs ) ; ( 2 ) high-frequency TENS group ( 110 Hz , 200 μs ) ; and ( 3 ) placebo TENS . Participants self-applied TENS for 45 minutes , a minimum of twice daily , for 6 weeks . Outcome measures were recorded at weeks 1 , 6 , 10 , and 32 . Primary outcome measures included : Visual Analog Scale for average LBP and the McGill Pain Question naire . Secondary outcome measures included : Visual Analog Scale for worst and weekly LBP , back and leg spasm ; Rol and Morris Disability Question naire ; Barthel Index ; Rivermead Mobility Index ; Multiple Sclerosis Quality of Life-54 Instrument , and a daily logbook . Data were analyzed blind using parametric and nonparametric tests , as appropriate . Results Results indicated a statistically significant interactive effect between groups for average LBP ( P=0.008 ) ; 1-way analysis of covariance did not show any significant effects at any time point once a Bonferonni correction was applied ( P>0.05 ) . However , clinical ly important differences were observed in some of the outcome measures in both active treatment groups during the treatment and follow-up periods . Discussion Although not statistically significant , the observed effects may have implication s for the clinical prescription and the use of TENS within this population In 23 patients with pancreatitis , daily pain for at least 3 months , and no abuse of alcohol , the pain-relieving effect of electroacupuncture ( 13 patients ) or transcutaneous electric nerve stimulation ( TENS ) ( 16 patients ) was studied . In two prospect i ve studies with a cross-over design , active acupuncture was compared with sham acupuncture , and TENS of the segmental points of the pancreas with sham treatment . Neither electroacupuncture nor TENS brought about pain relief that could substitute for or supplement medical treatment
Output:
| We were therefore unable to conclude with any confidence that , in people with chronic pain , TENS is harmful , or beneficial for pain control , disability , health-related quality of life , use of pain relieving medicines , or global impression of change . |
MS211830 | ***TASK*** the task is to summarize an input biomedical literature 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 : Interferon ( IFN ) beta has repeatedly shown benefit in multiple sclerosis ( MS ) in reducing the rate of relapse , the disease activity as shown with magnetic resonance imaging and , to some degree , the progression of disability ; however , it is unknown how much the therapeutic response depends on the dose , the subgroup involved , and the disease stage . This multicentre , double blind , placebo controlled study explored the dose−response curve by examining the clinical benefit of low dose IFN beta-1a ( Rebif ® ) , 22 μg subcutaneously once weekly , in patients with secondary progressive MS . Methods : A total of 371 patients with clinical ly definite SPMS were r and omised to receive either placebo or subcutaneous IFN beta-1a , 22 μg once weekly , for 3 years . Clinical assessment s were performed every 6 months . The primary outcome was time to sustained disability , as defined by time to first confirmed 1.0 point increase on the Exp and ed Disability Status Scale ( EDSS ) . Secondary outcomes included a sensitive disability measure and relapse rate . Results : Treatment had no beneficial effect on time to confirmed progression on either the EDSS ( hazard ratio ( HR ) = 1.13 ; 95 % confidence interval ( CI ) 0.82 to 1.57 ; p = 0.45 for 22 μg v placebo ) or the Regional Functional Status Scale ( HR = 0.93 ; 95 % CI 0.68 to 1.28 ; p = 0.67 ) . Other disability measures were also not significantly affected by treatment . Annual relapse rate was 0.27 with placebo and 0.25 with IFN ( rate ratio = 0.90 ; 95 % CI 0.64 to 1.27 ; p = 0.55 ) . The drug was well tolerated with no new safety concerns identified . No significant gender differences were noted . Conclusions : This patient population was less clinical ly active than SPMS population s studied in other trials . Treatment with low dose , IFN beta-1a ( Rebif ® ) once weekly did not show any benefit in this study for either disability or relapse outcomes , including a subgroup with preceding relapses . These results add a point at one extreme of the dose−response spectrum of IFN beta therapy in MS , indicating that relapses in this phase may need treatment with higher doses than in the initial phases Background : The recently completed placebo-controlled multicenter r and omized trial of interferon beta-1b ( Betaferon ) in 718 patients with secondary progressive MS shows significant delay of disease progression and reduction of relapse rate . This study provides an opportunity to assess the level of relationship between clinical and MRI outcomes in this cohort of patients with secondary progressive MS . Methods : Brain T2-weighted lesion volume was measured annually in all available patients , with visual analysis to identify any new or enlarging ( active ) T2 lesions at each annual time point . A subgroup of 125 patients had monthly gadolinium-enhanced , T1-weighted imaging at months 0 to 6 and 18 to 24 . Relapses were documented and exp and ed disability status scale ( EDSS ) was measured every 3 months . Results : For the annual MRI outcomes , a significant but modest correlation was identified between the change in T2 lesion volume from baseline to the final scan and the corresponding change from baseline in EDSS ( r = 0.17 , p < 0.0001 ) . There were significant correlations between the cumulative number of active T2 lesions and 1 ) change in EDSS ( r = 0.18 , p < 0.0001 ) and 2 ) relapse rate ( r = 0.24 , p < 0.0001 ) . In the subgroup of 125 patients undergoing monthly imaging , MRI lesion activity was correlated with relapse rate over months 0 to 24 ( r = 0.24 , p = 0.006 ) but not with change in EDSS . Conclusions : These results confirm that the clinical –MRI relationships previously identified in relapsing-remitting MS still are apparent in the secondary progressive phase of the disease and support the use of MRI as a relevant outcome measure . In view of the relatively modest nature of the correlations , it seems unwise to rely on such MRI measures alone as primary efficacy variables in secondary progressive MS trials Recently , the clinical efficacy of interferon beta-1b ( IFNbeta-1b ) was demonstrated for secondary progressive ( SP ) multiple sclerosis in a European multicentre study . We evaluated the effect of IFNbeta-1b treatment on the rate of development of hypointense T(1 ) MRI lesions , a putative marker of axonal damage . Unenhanced T(1)-weighted images were obtained in a subgroup of 95 multiple sclerosis patients from five centres at 6-month intervals ; this subgroup was similar to the total study population for all demographic , clinical and MRI parameters . An experienced observer blinded to the clinical data and treatment allocation measured volumes . The median baseline lesion load for hypointense T(1 ) lesions was 5.1 cm(3 ) for placebo-treated and 4.9 cm(3 ) for IFNbeta-1b-treated patients ( P = 0.56 ) . Placebo-treated patients showed an increase in T(1 ) lesion load by a median of 14 % per year ( P = 0.0002 compared with baseline ) ; this was reduced to 7.7 % per year in the IFNbeta-1b-treated patients ( P = 0.003 versus placebo ) . In the IFNbeta-1b arm there was a statistically significant correlation between absolute change in Exp and ed Disability Status Scale scores and T(1 ) lesion load by month 36 ( r = 0.38 , P = 0.0015 ) . In patients with SP multiple sclerosis , IFNbeta-1b treatment reduces the development of hypointense T(1 ) lesions , suggesting that reduced axonal damage in lesions may play a part in the beneficial effect that is observed clinical ly Several phase III studies have proven that the beta-interferons have positive effects on the number and severity of acute exacerbations of relapsing remitting multiple sclerosis . Recently the first study on the effectiveness of interferon beta-1b in secondary progressive multiple sclerosis was published . In a multicenter , double-blind , r and omized , Placebo-controlled study 718 patients with secondary progressive multiple sclerosis and an exp and ed disability status scale ( EDSS ) value between 3.0 and 6.5 were treated with either 8 Mio.interferon beta-1b or Placebo subcutaneously every second day for two to three years . The primary study end-point was the time until confirmed progression of the disease as signified by a one point increase of the EDSS value ( for initial EDSS values between 3.0 and 5.5 ) or 0.5 point increase when the initial EDSS value was between 6.0 and 6.5 . After two years an interim analysis showed a highly significant difference in delay of disease progression by nine to twelve months for the treatment group ( p = 0.0008 ) . This means that interferon beta-1b is the first recombinant beta-interferon to be shown effective in the treatment of secondary progressive multiple sclerosis Abstract Combination therapy may benefit the subgroup of patients with secondary progressive multiple sclerosis ( SPMS ) who do not respond to interferon beta ( IFNB ) . We performed a two-year study of azathioprine ( AZA ) combined with IFNB-1b in SPMS patients who had not responded well to IFNB-1b alone . Patients with SPMS were eligible for this non-controlled prospect i ve study if they had two or more relapses requiring corticosteroid treatment or deteriorated by at least 0.5 points on the Exp and ed Disability Status Scale ( EDSS ) while on IFNB-1b in the year preceeding the study . Patients were to continue treatment with IFNB-1b ( 8 MIU qod , subcutaneous ) and received AZA ( 50 mg tid , oral ) . Safety was assessed in terms of adverse reactions and laboratory measures grade d according to the WHO toxicity scale . Efficacy was explored by changes in relapse rate , EDSS , 9-hole peg test ( 9-HPT ) , neuropsychological scores , and magnetic resonance imaging ( MRI ) results . Neutralizing antibodies ( NAB ) were measured . Ten SPMS patients ( 6 females ) with a median EDSS score of 4.5 were enrolled . One patient withdrew because of gastrointestinal complaints , one was withdrawn owing to poor compliance , and 8 patients completed therapy . The only frequent side effect was lymphopenia , reported at least once in all patients . Annual relapse rate was reduced by approximately 50 % in the second year . There was a significant trend for EDSS increase . Total lesion load measured by MRI decreased at 12 and 24 months ; only one patient had active lesions . No changes were seen in the 9-HPT . There was a significant improvement in neuropsychological tests after 24 months ( p = 0.045 ) . One patient tested positive for NAB throughout the study , and transient NAB were detected in 4 patients . In conclusion , combination therapy with IFNB-1b and AZA was safe and generally well tolerated in patients with SPMS . Strict clinical and laboratory monitoring is recommended during this combination therapy Background Evidence for efficacy of disease-modifying drugs in multiple sclerosis ( MS ) comes from trials of short duration . We report results from a 16 y , retrospective follow-up of the pivotal interferon β-1b ( IFNB-1b ) study . Methods The 372 trial patients were r and omly assigned to placebo ( n=123 ) , IFNB-1b 50 μg ( n=125 ) or IFNB-1b 250 μg ( n=124 ) subcutaneously every other day for at least 2 y. Some remained r and omised for up to 5 y but , subsequently , patients received treatment according to physicians ' discretion . Patients were re-contacted and asked to participate . Efficacy related measures included MRI parameters , relapse rate , the Exp and ed Disability Status Scale , the Multiple Sclerosis Functional Composite Measure and conversion to secondary progressive MS . Results Of the 88.2 % ( 328/372 ) of patients who were identified , 69.9 % ( 260/372 ) had available case report forms . No differences in outcome between original r and omisation groups could be discerned using st and ard disability and MRI measures . However , mortality rates among patients originally treated with IFNB-1b were lower than in the original placebo group ( 18.3 % ( 20/109 ) for placebo versus 8.3 % ( 9/108 ) for IFNB-1b 50 μg and 5.4 % ( 6/111 ) for IFNB-1b 250 μg ) . Conclusions The original treatment assignment could not be shown to influence st and ard assessment s of long-term efficacy . On- study behaviour of patients was influenced by factors that could not be controlled with the sacrifice of r and omisation and blinding . Mortality was higher in patients originally assigned to placebo than those who had received IFNB-1b 50 μg or 250 μg . The data set provides important re sources to explore early predictors of long-term outcome This manuscript describes the outline of a double-blind , placebo-controlled , ( European ) , multicentre phase III study to evaluate the safety and efficacy of 8 MIU of interferon beta-Ib given subcutaneously every other day for 3 years in patients with secondary progressive multiple sclerosis . The primary efficacy variable of this trial is the time to confirmed neurological deterioration as documented by the Exp and ed Disability Status Scale . The essentials of the study design are presented , including the rationale for the performance of the study and the selection of both clinical and magnetic resonance imaging outcome parameters Objective : To investigate the relationship between neutralizing antibodies ( NAB ) and disease progression , relapses , and MR measures of MS . Methods : Sequential serum sample s from all 718 patients of the European Study Group in Interferon β-1b in Secondary Progressive MS were analyzed to investigate relations between NAB and disease progression , relapses , and MR measures . Results : This study showed no attenuating effect of NAB development on progression in disability . The effects of NAB on relapse rate showed substantial variation , depending on the statistical approach and definition of positivity , though analyses comparing low- and high-NAB+ periods with NAB− periods suggested a titer-related effect . MR T2 lesion volume changes from baseline were significantly higher for NAB+ patients but remained lower than for placebo patients . A substantial proportion of NAB+ patients became NAB−. No untoward effect of NAB development on safety was observed . Conclusion : These results support the conclusion that even though high NAB titers appear to have impact on treatment efficacy with respect to relapses , treatment decisions should be based primarily on clinical grounds Objective : To determine the percentage of patients with residual deficits following multiple sclerosis ( MS ) exacerbations and the magnitude of those deficits using a data base of pooled placebo patients from clinical trials . Methods : A data base of patients assigned to the placebo group in several r and omized clinical trials was queried to determine those patients with Exp and ed Disability Status Scale ( EDSS ) and Scripps Neurologic Rating Scale assessment s prior to , at the time of , and after an acute exacerbation of MS . The extent of deficit present at these time points was compared to determine the acute effect of exacerbations and the degree of persistent disability . Results : Forty-two percent of patients had residual deficit of at least 0.5 and 28 % had residual of ≥1.0 EDSS units , at an average of 64 days after an exacerbation . The results were reproduced across subsequent exacerbations and were sustained over
Output:
| The risk of developing new active brain lesions decreased over time but this data was obtained from single studies on Magnetic Resonance Imaging ( MRI ) , performed in subgroups of patients ; in spite of no effect on progression , the radiological data supported an effect on MRI parameters .
The safety profile reflects what is commonly reported in MS IFN-treated patients .
Recombinant IFN beta does not prevent the development of permanent physical disability in SPMS .
We were unable to verify the effect on cognitive function for the lack of comparable data .
This treatment significantly reduces the risk of relapse and of short -term relapse-related disability .
Overall , these results show that IFNs ' anti-inflammatory effect is unable to retard progression , when established .
We believe that this review gives conclusive evidence on the clinical efficacy of IFNs versus placebo in SPMS |
MS211831 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background : This study aim ed to determine whether combination S-1 plus cisplatin ( CDDP ) therapy , the most widely used therapy for Japanese patients with advanced gastric cancer , and the novel oral antiangiogenic agent TSU-68 could contribute to gastric cancer treatment . Methods : Ninety-three patients with chemotherapy-naïve unresectable or recurrent advanced gastric cancers were r and omised into two groups : TSU-68 plus S-1/CDDP ( group A ) and S-1/CDDP ( group B ) groups . Both patient groups received identical S-1 and CDDP dosages . TSU-68 was orally administered for 35 consecutive days . Group B patients received S-1 orally twice daily for three consecutive weeks , followed by intravenous CDDP on day 8 . The primary endpoint was progression-free survival ( PFS ) . Results : Median PFS periods were 208 and 213 days in groups A and B , respectively ( P=0.427 ) . Median survival periods for groups A and B were 497.0 and 463.5 days , respectively ( P=0.219 ) . No statistically significant differences were noted for PFS , survival or the adverse event ( AE ) incidence rate . All AEs were expected according to previous reports for TSU-68 , TS-1 , and CDDP . Conclusion : Combination therapy involving TSU-68 , S-1 , and CDDP was safe and well tolerated in patients with chemotherapy-naïve unresectable or recurrent advanced gastric cancers . However , factors related to therapeutic efficacy should be investigated further 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 BACKGROUND Clinical data showed promising antitumour activity with feasible tolerability for matuzumab plus epirubicin , cisplatin and capecitabine ( ECX ) chemotherapy in untreated advanced oesophago-gastric ( OG ) cancer . The aim was to evaluate the efficacy of matuzumab plus ECX versus ECX alone . PATIENTS AND METHODS In this multicentre , r and omised open-label phase II study , 72 patients with metastatic OG cancer were r and omly assigned to either 800 mg matuzumab weekly plus epirubicin 50 mg/m² , cisplatin 60 mg/m² on day 1 and capecitabine 1250 mg/m² daily in a 21-day cycle ( ECX ) or the same ECX regimen alone . The primary end point was objective response . Secondary end points included progression-free survival ( PFS ) , overall survival ( OS ) , quality of life , safety and tolerability . RESULTS Following r and om assignment , 35 patients ( median age 59 years ) received ECX/matuzumab and 36 patients ( median age 64 years ) ECX . The addition of matuzumab to ECX did not improve objective response : 31 % for ECX/matuzumab [ 95 % confidence interval ( CI ) 17 - 49 ] compared with 58 % for the ECX arm ( 95 % CI 41 - 74 ) P = 0.994 ( one sided ) . There was no significant difference in median PFS : 4.8 months ( 95 % CI 2.9 - 8.1 ) for ECX/matuzumab versus 7.1 months ( 95 % CI 4.4 - 8.5 ) for ECX , or in median OS : 9.4 months ( 95 % CI 7.5 - 16.2 ) , compared with 12.2 months ( 95 % CI 9.8 - 13.8 months ) . Grade 3/4 treatment-related toxicity was observed in 27 and 25 patients in the ECX/matuzumab and ECX groups , respectively . CONCLUSION Matuzumab 800 mg weekly combined with ECX chemotherapy does not increase response or survival for patients with advanced OG cancer . Therefore , ECX/matuzumab should not be examined further in phase III trials BACKGROUND Dysregulation of the hepatocyte growth factor (HGF)/MET pathway promotes tumour growth and metastasis . Rilotumumab is a fully human , monoclonal antibody that neutralises HGF . We aim ed to assess the safety , efficacy , biomarkers , and pharmacokinetics of rilotumumab combined with epirubicin , cisplatin , and capecitabine ( ECX ) in patients with advanced gastric or oesophagogastric junction cancer . METHODS We recruited patients ( ≥18 years old ) with unresectable locally advanced or metastatic gastric or oesophagogastric junction adenocarcinoma , an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0 or 1 , who had not received previous systemic therapy , from 43 sites worldwide . Phase 1b was an open-label , dose de-escalation study to identify a safe dose of rilotumumab ( initial dose 15 mg/kg intravenously on day 1 ) plus ECX ( epirubicin 50 mg/m(2 ) intravenously on day 1 , cisplatin 60 mg/m(2 ) intravenously on day 1 , capecitabine 625 mg/m(2 ) twice a day orally on days 1 - 21 , respectively ) , administered every 3 weeks . The phase 1b primary endpoint was the incidence of dose-limiting toxicities in all phase 1b patients who received at least one dose of rilotumumab and completed the dose-limiting toxicity assessment window ( first cycle of therapy ) . Phase 2 was a double-blind study that r and omly assigned patients ( 1:1:1 ) using an interactive voice response system to receive rilotumumab 15 mg/kg , rilotumumab 7·5 mg/kg , or placebo , plus ECX ( doses as above ) , stratified by ECOG performance status and disease extent . The phase 2 primary endpoint was progression-free survival ( PFS ) , analysed by intention to treat . The study is registered with Clinical Trials.gov , number NCT00719550 . FINDINGS Seven of the nine patients enrolled in the phase 1b study received at least one dose of rilotumumab 15 mg/kg , only two of whom had three dose-limiting toxicities : palmar-plantar erythrodysesthesia , cerebral ischaemia , and deep-vein thrombosis . In phase 2 , 121 patients were r and omly assigned ( 40 to rilotumumab 15 mg/kg ; 42 to rilotumumab 7·5 mg/kg ; 39 to placebo ) . Median PFS was 5·1 months ( 95 % CI 2·9 - 7·0 ) in the rilotumumab 15 mg/kg group , 6·8 months ( 4·5 - 7·5 ) in the rilotumumab 7·5 mg/kg group , 5·7 months ( 4·5 - 7·0 ) in both rilotumumab groups combined , and 4·2 months ( 2·9 - 4·9 ) in the placebo group . The hazard ratio for PFS events compared with placebo was 0·69 ( 80 % CI 0·49 - 0·97 ; p=0·164 ) for rilotumumab 15 mg/kg , 0·53 ( 80 % CI 0·38 - 0·73 ; p=0·009 ) for rilotumumab 7·5 mg/kg , and 0·60 ( 80 % CI 0·45 - 0·79 ; p=0·016 ) for combined rilotumumab . Any grade adverse events more common in the combined rilotumumab group than in the placebo group included haematological adverse events ( neutropenia in 44 [ 54 % ] of 81 patients vs 13 [ 33 % ] of 39 patients ; anaemia in 32 [ 40 % ] vs 11 [ 28 % ] ; and thrombocytopenia in nine [ 11 % ] vs none ) , peripheral oedema ( 22 [ 27 % ] vs three [ 8 % ] ) , and venous thromboembolism ( 16 [ 20 % ] vs five [ 13 % ] ) . Grade 3 - 4 adverse events more common with rilotumumab included neutropenia ( 36 [ 44 % ] vs 11 [ 28 % ] ) and venous thromboembolism ( 16 [ 20 % ] vs four [ 10 % ] ) . Serious adverse events were balanced between groups except for anaemia , which occurred more frequently in the combined rilotumumab group ( ten [ 12 % ] vs none ) . INTERPRETATION Rilotumumab plus ECX had no unexpected safety signals and showed greater activity than placebo plus ECX . A phase 3 study of the combination in MET-positive gastric and oesophagogastric junction cancer is in progress . FUNDING Amgen BACKGROUND Trastuzumab , a monoclonal antibody against human epidermal growth factor receptor 2 ( HER2 ; also known as ERBB2 ) , was investigated in combination with chemotherapy for first-line treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer . METHODS ToGA ( Trastuzumab for Gastric Cancer ) was an open-label , international , phase 3 , r and omised controlled trial undertaken in 122 centres in 24 countries . Patients with gastric or gastro-oesophageal junction cancer were eligible for inclusion if their tumours showed overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation . Participants were r and omly assigned in a 1:1 ratio to receive a chemotherapy regimen consisting of capecitabine plus cisplatin or fluorouracil plus cisplatin given every 3 weeks for six cycles or chemotherapy in combination with intravenous trastuzumab . Allocation was by block r and omisation stratified by Eastern Cooperative Oncology Group performance status , chemotherapy regimen , extent of disease , primary cancer site , and measurability of disease , implemented with a central interactive voice recognition system . The primary endpoint was overall survival in all r and omised patients who received study medication at least once . This trial is registered with Clinical Trials.gov , number NCT01041404 . FINDINGS 594 patients were r and omly assigned to study treatment ( trastuzumab plus chemotherapy , n=298 ; chemotherapy alone , n=296 ) , of whom 584 were included in the primary analysis ( n=294 ; n=290 ) . Median follow-up was 18.6 months ( IQR 11 - 25 ) in the trastuzumab plus chemotherapy group and 17.1 months ( 9 - 25 ) in the chemotherapy alone group . Median overall survival was 13.8 months ( 95 % CI 12 - 16 ) in those assigned to trastuzumab plus chemotherapy compared with 11.1 months ( 10 - 13 ) in those assigned to chemotherapy alone ( hazard ratio 0.74 ; 95 % CI 0.60 - 0.91 ; p=0.0046 ) . The most common adverse events in both groups were nausea ( trastuzumab plus chemotherapy , 197 [ 67 % ] vs chemotherapy alone , 184 [ 63 % ] ) , vomiting ( 147 [
Output:
| There is uncertainty about the effect of adding targeted therapy to chemotherapy on survival outcomes in people with advanced gastric cancer , with very little information on its impact on quality of life .
There is more certain evidence of increased risk of adverse events and serious adverse events . |
MS211832 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To evaluate the effect of sodium and fructose restriction on mitochondrial DNA ( mtDNA ) content and systemic oxidative stress in a sample of overweight and pre hypertensive subjects . MATERIAL / METHODS Data and blood sample s were collected from 36 overweight and pre hypertensive patients r and omly assigned to either an isocaloric ( with respect to baseline ) low sodium-fructose diet or an isocaloric low sodium diet . Patients were followed for 8 weeks . We measured mitochondrial DNA ( mtDNA ) content from peripheral blood white cells by Real-time PCR and plasma malondialdehyde ( MDA ) and 2,4-dinitrophenylhydrazine ( DNPH ) as markers of reactive oxygen species ( ROS ) . RESULTS Compared to baseline , at week 8 there was a continued and significant increase in mtDNA in both the low sodium diet group [ 2.4 vs. 13.1 ( relative copy number ) , p<0.05 ] and the low sodium diet-fructose group ( 1.9 vs. 147.2 , p<0.05 ) . By week 8 there was a continued decrease in plasma DNPH levels in the low sodium diet group ( 4.6 vs. 2.6 , p<0.05 ) and in the low sodium diet-fructose group ( 5.8 vs. 2.2 , p<0.05 ) . No significant differences were found with MDA . CONCLUSION Our studies suggest that simple dietary measures such as reducing salt with or without restricting fructose can increase mtDNA and improve markers of oxidative stress
Output:
| The combination of low sodium and low fructose did increase mtDNA but it did not increase it more than the low sodium diet alone without fructose restriction .
This suggests that the eff ect appears dependent on sodium but not fructose .
Conversely , in isocaloric comparisons where energy intake is matched , these eff ects are not observed .
That is , fructose behaves no worse than any other carbohydrate [ 4 – 8 ] , although there may be a dosethreshold for some fasting lipid eff ects [ 4 , 10 – 12 ] .
This lack of eff ect remains true even under conditions of fructose overfeeding ( positive energy balance ) , as long as the comparison is matched for the excess calories .
Taken together , the main driver mediating any harm attributable to fructose appears to be excess energy .
In conclusion , there is insuffi cient evidence to conclude that fructose restriction has a signifi ca nt eff ect on mtDNA and oxidative stress when holding energy equal .
Energy imbalance appears to be a prerequisite for eliciting an eff ect . |
MS211833 | ***TASK*** the task is to summarize an input biomedical literature 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: 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 Results of the pilot study of the four counties r and omised controlled trial to evaluate the effectiveness of aromatherapy massage with 1 % Santalum album ( S and alwood ) ( group A ) when compared with massage with Sweet Almond Carrier oil , ( group B ) or S and alwood oil via an aromastone ( group C ) , in reducing levels of anxiety in palliative care . The aims of the pilot study were to evaluate the effectiveness of aromatherapy in reducing anxiety in patients receiving palliative care in four counties . The primary end points of the research were to report a statistically significant difference in anxiety scores between experimental group ( B ) and comparison groups ( A and C ) and to influence the integration of aromatherapy into all aspects of palliative care . The limited data of the pilot study ( N=34 ) tested the logistics of the research , particularly the 25 % attrition rate and the robustness of the data collection tools . The results were not substantial enough to generate coherent statistics . Therefore no assumptions could be drawn from these results due to the inconsistencies that were bound to occur in such a small sample . However , the results do seem to support the notion that S and alwood oil is effective in reducing anxiety The goal of this study was to investigate the impact of the essential oils of orange and lavender on anxiety , mood , alertness and calmness in dental patients . Two hundred patients between the ages of 18 and 77 years ( half women , half men ) were assigned to one of four independent groups . While waiting for dental procedures patients were either stimulated with ambient odor of orange or ambient odor of lavender . These conditions were compared to a music condition and a control condition ( no odor , no music ) . Anxiety , mood , alertness and calmness were assessed while patients waited for dental treatment . Statistical analyses revealed that compared to control condition both ambient odors of orange and lavender reduced anxiety and improved mood in patients waiting for dental treatment . These findings support the previous opinion that odors are capable of altering emotional states and may indicate that the use of odors is helpful in reducing anxiety in dental patients CONTEXT Interest in the use of alternative therapies to reduce anxiety in patients undergoing medical interventions is increasing . We sought to assess the effectiveness of aromatherapy involving essential oils in reducing preoperative anxiety in women undergoing abortions . SETTING An urban , free-st and ing abortion clinic in Vancouver , BC . PATIENTS 66 women waiting for surgical abortions . DESIGN A double blind , r and omized trial . INTERVENTION Ten minutes spent sniffing a numbered container with either a mixture of the essential oils vetivert , bergamot , and geranium ( treatment arm ) or a hair conditioner ( placebo ) . OUTCOME MEASURES Anxiety was measured before and after the intervention by using a verbal anxiety scale from 0 to 10 . RESULTS The anxiety score was reduced by 1.0 point ( 5.0 to 4.0 ) in the aromatherapy group and by 1.1 points ( 6.1 to 5.0 ) in the placebo group ( P = 0.71 ) . The 95 % CI on the 0.1 greater decrease in anxiety for the placebo group extends from 0.55 less ( favors aromatherapy ) to 0.75 greater ( favors placebo ) . CONCLUSION Aromatherapy involving essential oils is no more effective than having patients sniff other pleasant odors in reducing preprocedure anxiety OBJECTIVE Melissa officinalis ( lemon balm ) and Valeriana officinalis ( valerian ) have been used both traditionally and contemporaneously as mild sedatives , anxiolytics and hypnotics . Recent research has suggested that both may attenuate laboratory induced stress . As the two herbs are most often sold in combination with each other the current study assessed the anxiolytic properties of such a combination during laboratory-induced stress . METHODS In this double-blind , placebo-controlled , r and omized , balanced cross-over experiment , 24 healthy volunteers received three separate single doses ( 600 mg , 1200 mg , 1800 mg ) of a st and ardized product containing M. officinalis and V. officinalis extracts , plus a placebo , on separate days separated by a 7 day wash out period . Modulation of mood and anxiety were assessed during pre-dose and 1 h , 3 h and 6 h post-dose completions of a 20 min version of the Defined Intensity Stressor Simulation ( DISS ) battery . Cognitive performance on the four concurrent tasks of the battery was also assessed . RESULTS The results showed that the 600 mg dose of the combination ameliorated the negative effects of the DISS on ratings of anxiety . However , the highest dose ( 1800 mg ) showed an increase in anxiety that was less marked but which reached significance during one testing session . In addition , all three doses led to decrements in performance on the Stroop task module within the battery , and the two lower doses led to decrements on the overall score generated on the DISS battery . CONCLUSIONS These results suggest that a combination of Melissa officinalis and Valeriana officinalis possesses anxiolytic properties that deserve further investigation This study examined the effect of aromatherapy-massage in healthy postpartum mothers . A quasi-experimental between-groups design was used . Mothers who received aromatherapy-massage were compared with a control group who received st and ard postpartum care . Thirty-six healthy , first-time mothers with vaginal delivery of a full-term , healthy infant participated in this study . Sixteen mothers received a 30-minute aromatherapy-massage on the second postpartum day ; 20 mothers were in the control group . All mothers completed the following four st and ardized question naires before and after the intervention : 1 ) Maternity Blues Scale ; 2 ) State-Trait Anxiety Inventory ; 3 ) Profile of Mood States ( POMS ) ; and 4 ) Feeling toward Baby Scale . In the aromatherapy-massage group , posttreatment scores significantly decreased for the Maternity Blues Scale , the State-Anxiety Inventory , and all but one of the Profile of Mood States subscales . Posttreatment scores in the intervention group significantly increased in Profile of Mood States-Vigor subscale and the Approach Feeling toward Baby subscale . Scores in the intervention group significantly decreased in Conflict Index of Avoidance/Approach Feeling toward Baby subscale . Our results suggest that aromatherapy-massage might be an effective intervention for postpartum mothers to improve physical and mental status and to facilitate mother-infant interaction PURPOSE To test the effectiveness of supplementing usual supportive care with aromatherapy massage in the management of anxiety and depression in cancer patients through a pragmatic two-arm r and omized controlled trial in four United Kingdom cancer centers and a hospice . PATIENTS AND METHODS Two hundred eighty-eight cancer patients , referred to complementary therapy services with clinical anxiety and /or depression , were allocated r and omly to a course of aromatherapy massage or usual supportive care alone . RESULTS Patients who received aromatherapy massage had no significant improvement in clinical anxiety and /or depression compared with those receiving usual care at 10 weeks postr and omization ( odds ratio [ OR ] , 1.3 ; 95 % CI , 0.9 to 1.7 ; P = .1 ) , but did at 6 weeks postr and omization ( OR , 1.4 ; 95 % CI , 1.1 to 1.9 ; P = .01 ) . Patients receiving aromatherapy massage also described greater improvement in self-reported anxiety at both 6 and 10 weeks postr and omization ( OR , 3.4 ; 95 % CI , 0.2 to 6.7 ; P = .04 and OR , 3.4 ; 95 % CI , 0.2 to 6.6 ; P = .04 ) , respectively . CONCLUSION Aromatherapy massage does not appear to confer benefit on cancer patients ' anxiety and /or depression in the long-term , but is associated with clinical ly important benefit up to 2 weeks after the intervention The purpose of this study was to assess the effects of water , lavender , or rosemary scent on physiology and mood state following an anxiety-provoking task . The nonsmoking participants , ages 18–30 years , included 42 women and 31 men who reported demographic information and measures of external temperature and heart rate were taken prior to introduction of an anxiety-eliciting task and exposure to lavender , rosemary , or water scents . Following the task , participants completed the Profile of Mood States to assess mood , and temperature and heart rate were reassessed . Participants rated the pleasantness of the scent received . When pleasantness ratings of scent were covaried , physiological changes in temperature and heart rate did not differ based on scent exposure , but mood ratings differed by scent condition . Participants in the rosemary condition scored higher on measures of tension – anxiety and confusion – bewilderment relative to the lavender and control conditions . The lavender and control conditions showed higher mean vigor – activity ratings relative to the rosemary group , while both rosemary and lavender scents were associated with lower mean ratings on the fatigue – inertia subscale , relative to the control group . These results suggest that , when individual perception of scent pleasantness is controlled , scent has the potential to moderate different aspects of mood following an anxiety-provoking task OBJECTIVE The objective is to identify whether single 20 min massage sessions were safe and effective in reducing stress levels of isolated haematological oncology patients . DESIGN Based on a r and omised controlled trial , 39 patients were r and omised to aromatherapy , massage or rest ( control ) arm . MEASURES The measures were serum cortisol and prolactin levels , quality of life ( EORTC QLQ-C30 ) and semi-structured interviews . Primary outcome measure was the fall in serum cortisol levels . RESULTS A significant difference was seen between arms in cortisol ( P=0.002 ) and prolactin ( p=0.031 ) levels from baseline to 30 min post-session . Aromatherapy and massage arms showed a significantly greater drop in cortisol than the rest arm . Only the massage arm had a significantly greater reduction in prolactin then the rest arm . The EORTC QLQ-C30 showed a significant reduction in ' need for rest ' for patients in both experimental arms compared with the control arm , whereas the semi-structured interviews identified a universal feeling of relaxation in patients in the experimental arms . CONCLUSION This pilot study demonstrated that in isolated haematological oncology patients , a significant reduction in cortisol could be safely achieved through massage , with associated improvement in psychological well-being . The implication s are discussed The purpose of this study was to evaluate the use of aromatherapy to reduce anxiety prior to a scheduled colonoscopy or esophagogastroduodenoscopy . A controlled , prospect i ve study was done on a convenience sample of 118 patients . The “ state ” component of the State Trait Anxiety Inventory ( STAI ) was used to evaluate patients ' anxiety levels pre- and postaromatherapy . The control group was given an inert oil ( placebo ) for inhalation , and the experimental group was given the essential oil , lavender , for inhalation . The STAI state anxiety raw score revealed that patients were at the 99th ( women ) and 96th ( men ) percentiles for anxiety . The intervention group and the control group had similar levels of state anxiety prior to the beginning of the study ( t[116 ] = .47 , p = .64 ) . There was no difference in state anxiety levels between pre- and postplacebo inhalation in the control group ( t[112 ] = .48 , p = .63 ) . There was no statistical difference in state anxiety levels between pre- and postlavender inhalation in the experimental group ( t[120 ] = .73 , p = .47 ) . Although this study did not show aromatherapy to be effective based on statistical analysis , patients did generally report the lavender scent to be pleasant . Lavender is an inexpensive and popular technique for relaxation that can be offered to patients as an opportunity to promote preprocedural stress reduction in a hospital setting Benzodiazepines remain widely used for the treatment of anxiety disorders despite prominent , often limiting side effects including sedation , muscle relaxation , and ataxia . A compound producing a robust anxiolytic action comparable to benzodiazepines , but lacking these limiting side effects at therapeutic doses ( an anxioselective agent ) , would represent an important advance in the treatment of generalized anxiety disorder , and perhaps other anxiety disorders . Here we report that the pyrazolo[1,5
Output:
| Most of the studies indicated positive effects to quell anxiety .
It is recommended that aromatherapy could be applied as a complementary therapy for people with anxiety symptoms . |
MS211834 | ***TASK*** the task is to summarize an input biomedical literature 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 : In the And ean Region , HIV and sexually transmitted infections ( STI ) are most prevalent among men who have sex with men ( MSM ) , but incidence estimates and associated factors have never been prospect ively assessed . Methods : A cohort of 1056 high-risk HIV-negative MSM in Lima , Peru , were recruited during 1998 - 2000 ( the ALASKA Cohort ) , and a nested case-control analysis was conducted between seroconverters and nonseroconverters , matched 1:3 by age and duration of follow-up for comparison of risk behaviors , acute retroviral symptoms , circumcision , and STI . Results : During average follow-up of 335 days , 34 men seroconverted , providing a HIV incidence estimate of 3.5 per 100 person-years [ 95 % confidence interval ( CI ) : 2.3 to 4.7 ] . High syphilis ( 8.4 per 100 person-years , 95 % CI : 6.7 to 10.1 ) and herpes simplex virus type 2 ( HSV-2 ) infection ( 10.4 per 100 person-years , 95 % CI : 8.6 to 11.9 ) incidence estimates were obtained . HIV seroconverters were more likely than men who remained seronegative to report fever ≥3 days ( 46 % vs. 7 % ) , to seek medical care ( 62 % vs. 27 % ) , and to have ≥1 casual partner ( 86.2 % vs. 74.1 % ) since their last visit . HIV seroconverters also were more likely to have acquired syphilis or HSV-2 infection ( 31 % vs. 8 % among initially HSV-2-seronegative men ) although they were less likely to be circumcised ( 4.2 % vs. 20.6 % , a nonsignificant difference ) . In multivariate analysis , incident syphilis or HSV-2 infection ( odds ratio [ OR ] : 5.9 , 95 % CI : 1.5 to 22.7 ) and sex with any casual partner ( OR : 4.8 , 95 % CI : 0.9 to 26.2 ) were associated with HIV seroconversion . Conclusions : STI that may cause anogenital ulcers are important risk factors for HIV acquisition among high-risk MSM in Lima , a population with a very high HIV incidence estimate . Synergistic interventions focusing in preventing both HIV and HSV-2 , like male circumcision , are warranted to be assessed , especially in MSM population s with low levels of circumcision and high incidence estimates of ulcerative STI Background Although HIV treatment as prevention ( TasP ) via early antiretroviral therapy ( ART ) has proven to reduce transmissions among HIV-serodiscordant couples , its full implementation in developing countries remains a challenge . In this study , we determine whether China 's current HIV treatment program prevents new HIV infections among discordant couples in rural China . Methods A prospect i ve , longitudinal cohort study was conducted from June 2009 to March 2011 , in rural Yunnan . A total of 1,618 HIV-discordant couples were eligible , 1,101 were enrolled , and 813 were followed for an average of 1.4 person-years ( PY ) . Routine ART was prescribed to HIV-positive spouses according to eligibility ( CD4<350 cells/µl ) . Seroconversion was used to determine HIV incidence . Results A total of 17 seroconversions were documented within 1,127 PY of follow-up , for an overall incidence of 1.5 per 100 PY . Epidemiological and genetic evidence confirmed that all 17 seroconverters were infected via marital secondary sexual transmission . Having an ART-experienced HIV-positive partner was associated with a lower rate of seroconvertion compared with having an ART-naïve HIV-positive partner ( 0.8 per 100 PY vs. 2.4 per 100 PY , HR = 0.34 , 95%CI = 0.12–0.97 , p = 0.0436 ) . While we found that ART successfully suppressed plasma viral load to < 400 copies/ml in the majority of cases ( 85.0 % vs. 19.5 % , p<0.0001 at baseline ) , we did document five seroconversions among ART-experienced subgroup . Conclusions ART is associated with a 66 % reduction in HIV incidence among discordant couples in our sample , demonstrating the effectiveness of China 's HIV treatment program at preventing new infections , and providing support for earlier ART initiation and TasP implementation in this region Introduction : We explored factors associated with differential HIV incidence among women participating in a HIV prevention trial in Harare , Durban , and Johannesburg . The trial had shown no effect of the intervention ( diaphragm and lubricant gel ) on HIV incidence . Methods : A prospect i ve cohort analysis was conducted of trial participants followed for 12 - 24 months . Sociodemographic , biological , and behavioral data were collected at baseline and at quarterly visits . Factors associated with HIV incidence were estimated using multivariable Cox regression models , stratified by study location . Attributable risk was calculated from the adjusted hazard ratios ( AHR ) . Results : There were 309 incident HIV infections among the 4948 women in the analysis . HIV incidence was highest in Durban [ 6.75/100 person-years ; 95 % confidence interval ( CI ) : 5.74 to 7.93 ] , lower in Johannesburg ( 3.33/100 person-years ; 95 % CI : 2.51 to 4.44 ) , and lowest in Harare ( 2.72/100 person-years ; 95 % CI : 2.26 to 3.26 ) . Sexually transmitted infections were important risk factors in Harare [ prevalent herpes simplex virus type 2 ( HSV2 ) AHR = 2.56 , 95 % CI : 1.61 to 4.06 ; incident HSV2 AHR = 12.60 , 95 % CI : 2.13 to 21.87 ; Neisseria gonorrhoeae AHR = 6.82 , 95 % CI : 2.13 to 21.87 ] and in Durban ( prevalent HSV2 AHR = 1.64 , 95 % CI : 1.07 to 2.51 ; N. gonorrhoeae AHR = 4.40 , 95 % CI : 2.07 to 9.39 ) . In Durban , having multiple partners ( adjusted odds ratio ( AOR ) = 1.78 95 % CI : 1.11 to 2.85 ) and sex although a partner was under the influence of alcohol/drugs ( AOR = 1.51 95 % CI : 1.05 to 2.16 ) significantly increased risk , whereas in Johannesburg , sexual debut < 16 years ( AOR = 2.60 95 % CI : 1.30 to 5.17 ) was a strong predictor of HIV acquisition . Discussion : Important differences were seen in drivers of HIV incidence at the 3 study locations . Results from this analysis imply that targeted HIV programing could have a large impact on incident HIV infection in women , and that the most effective approach will likely vary based on knowledge of the local situation/epidemiology Objective : We assessed the protective effect of medical male circumcision ( MMC ) against HIV , herpes simplex virus type 2 ( HSV-2 ) , and genital ulcer disease ( GUD ) incidence . Design : Two thous and , seven hundred and eighty-seven men aged 18–24 years living in Kisumu , Kenya were r and omly assigned to circumcision ( n=1391 ) or delayed circumcision ( n = 1393 ) and assessed by HIV and HSV-2 testing and medical examinations during follow-ups at 1 , 3 , 6 , 12 , 18 , and 24 months . Methods : Cox regression estimated the risk ratio of each outcome ( incident HIV , GUD , HSV-2 ) for circumcision status and multivariable models estimated HIV risk associated with HSV-2 , GUD , and circumcision status as time-varying covariates . Results : HIV incidence was 1.42 per 100 person-years . Circumcision was 62 % protective against HIV [ risk ratio = 0.38 ; 95 % confidence interval ( CI ) 0.22–0.67 ] and did not change when controlling for HSV-2 and GUD ( risk ratio = 0.39 ; 95 % CI 0.23–0.69 ) . GUD incidence was halved among circumcised men ( risk ratio = 0.52 ; 95 % CI 0.37–0.73 ) . HSV-2 incidence did not differ by circumcision status ( risk ratio = 0.94 ; 95 % CI 0.70–1.25 ) . In the multivariable model , HIV seroconversions were tripled ( risk ratio = 3.44 ; 95 % CI 1.52–7.80 ) among men with incident HSV-2 and seven times greater ( risk ratio = 6.98 ; 95 % CI 3.50–13.9 ) for men with GUD . Conclusion : Contrary to findings from the South African and Ug and an trials , the protective effect of MMC against HIV was independent of GUD and HSV-2 , and MMC had no effect on HSV-2 incidence . Determining the causes of GUD is necessary to reduce associated HIV risk and to underst and how circumcision confers protection against GUD and HIV BACKGROUND Male circumcision could provide substantial protection against acquisition of HIV-1 infection . Our aim was to determine whether male circumcision had a protective effect against HIV infection , and to assess safety and changes in sexual behaviour related to this intervention . METHODS We did a r and omised controlled trial of 2784 men aged 18 - 24 years in Kisumu , Kenya . Men were r and omly assigned to an intervention group ( circumcision ; n=1391 ) or a control group ( delayed circumcision , 1393 ) , and assessed by HIV testing , medical examinations , and behavioural interviews during follow-ups at 1 , 3 , 6 , 12 , 18 , and 24 months . HIV seroincidence was estimated in an intention-to-treat analysis . This trial is registered with Clinical Trials.gov , with the number NCT00059371 . FINDINGS The trial was stopped early on December 12 , 2006 , after a third interim analysis review ed by the data and safety monitoring board . The median length of follow-up was 24 months . Follow-up for HIV status was incomplete for 240 ( 8.6 % ) participants . 22 men in the intervention group and 47 in the control group had tested positive for HIV when the study was stopped . The 2-year HIV incidence was 2.1 % ( 95 % CI 1.2 - 3.0 ) in the circumcision group and 4.2 % ( 3.0 - 5.4 ) in the control group ( p=0.0065 ) ; the relative risk of HIV infection in circumcised men was 0.47 ( 0.28 - 0.78 ) , which corresponds to a reduction in the risk of acquiring an HIV infection of 53 % ( 22 - 72 ) . Adjusting for non-adherence to treatment and excluding four men found to be seropositive at enrollment , the protective effect of circumcision was 60 % ( 32 - 77 ) . Adverse events related to the intervention ( 21 events in 1.5 % of those circumcised ) resolved quickly . No behavioural risk compensation after circumcision was observed . INTERPRETATION Male circumcision significantly reduces the risk of HIV acquisition in young men in Africa . Where appropriate , voluntary , safe , and affordable circumcision services should be integrated with other HIV preventive interventions and provided as expeditiously as possible Vaginal Gel Versus HIV HIV prevention technologies for women are urgently needed , especially in sub-Saharan Africa where young women bear the greatest burden of the HIV epidemic . Abdool Karim et al. ( p. 1168 ; published online 19 July ) present the results of the CAPRISA 004 r and omized control trial . The nearly 3-year-long trial , conducted in urban and rural South African women , tested the efficacy of a vaginal gel containing the antiretroviral drug tenofovir in preventing HIV infection . The dosing strategy required application of the gel both before and after coitus , and with this regime HIV infection was reduced by approximately 39 % overall , by 54 % in women with high adherence to the protocol , and with no increase in overall adverse event rates . Tenofovir in a vaginal gel formulation shows significant protection against HIV infection in a r and omized control trial . The Centre for the AIDS Program of Research in South Africa ( CAPRISA ) 004 trial assessed the effectiveness and safety of a 1 % vaginal gel formulation of tenofovir , a nucleotide reverse transcriptase inhibitor , for the prevention of HIV acquisition in women . A double-blind , r and omized controlled trial was conducted comparing tenofovir gel ( n = 445 women ) with placebo gel ( n
Output:
| Interpretation We found evidence that HSV-2 infection increases the risk of HIV acquisition .
Interventions targeting HSV-2 , such as new HSV vaccines , have the potential for additional benefit against HIV , which could be particularly powerful in regions with a high incidence of co-infection . |
MS211835 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Objectives To evaluate salt sensitivity in elderly subjects with different forms of hypertension and controls and to investigate any modulation by genotype Design R and omized , double-blinded , placebo-controlled latin-square Setting Tertiary referral hospital Participants Community subjects ( n = 46 ) aged ⩾ 60 years classified as isolated systolic hypertension [ ISH ; systolic blood pressure ( SBP ) ⩾ 160 , diastolic blood pressure ( DBP ) < 90 mmHg , n = 19 ] , diastolic ± systolic hypertension ( SDH ; DBP ⩾ 90 mmHg , n = 10 ) and normotension ( SBP < 160 , DBP < 90 mmHg , n = 17 ) . Intervention Four 14 day treatments , 50 , 100 , 200 and 300 mmol/day of sodium chloride supplementation interspersed with 14 day washout periods on a salt-restricted diet . Main outcome measures The 24 h blood pressure , heart rate , weight , urinary sodium and creatinine clearance measured during baseline , treatment and washout periods and angiotensinogen ( AGT ) and angiotensin converting enzyme ( ACE ) genotypes . Results For the entire cohort , the mean ± st and ard error ( SE ) of change from baseline in SBP for 50 , 100 , 200 and 300 mmol/day salt was 7.7 ± 2.4 , 12.1 ± 2.4 , 16.6 ± 3.0 , 18.5 ± 2.6 mmHg , respectively . For DBP , the respective changes were:− 0.1 ± 1.5 , 2.4 ± 1.6 , 3.0 ± 1.5 , 5.8 ± 1.7 mmHg . The increase in SBP among ISH subjects was significantly higher than among subjects in the SDH and normotensive groups ( P < 0.05 ) . AGT genotype influenced the effect of salt dose on the change in DBP ( P = 0.006 ) but not SBP ( P = 0.7 ) . Conclusions In healthy , older subjects , a linear increase in BP occurred with increasing salt dose , it appeared most pronounced in ISH subjects and could be modulated by AGT genotype The aim of the present study was to evaluate the effects of a normal-sodium ( 120 mmol sodium ) diet compared with a low-sodium diet ( 80 mmol sodium ) on readmissions for CHF ( congestive heart failure ) during 180 days of follow-up in compensated patients with CHF . A total of 232 compensated CHF patients ( 88 female and 144 male ; New York Heart Association class II-IV ; 55 - 83 years of age , ejection fraction < 35 % and serum creatinine < 2 mg/dl ) were r and omized into two groups : group 1 contained 118 patients ( 45 females and 73 males ) receiving a normal-sodium diet plus oral furosemide [ 250 - 500 mg , b.i.d . ( twice a day ) ] ; and group 2 contained 114 patients ( 43 females and 71 males ) receiving a low-sodium diet plus oral furosemide ( 250 - 500 mg , b.i.d . ) . The treatment was given at 30 days after discharge and for 180 days , in association with a fluid intake of 1000 ml per day . Signs of CHF , body weight , blood pressure , heart rate , laboratory parameters , ECG , echocardiogram , levels of BNP ( brain natriuretic peptide ) and aldosterone levels , and PRA ( plasma renin activity ) were examined at baseline ( 30 days after discharge ) and after 180 days . The normal-sodium group had a significant reduction ( P<0.05 ) in readmissions . BNP values were lower in the normal-sodium group compared with the low sodium group ( 685+/-255 compared with 425+/-125 pg/ml respectively ; P<0.0001 ) . Significant ( P<0.0001 ) increases in aldosterone and PRA were observed in the low-sodium group during follow-up , whereas the normal-sodium group had a small significant reduction ( P=0.039 ) in aldosterone levels and no significant difference in PRA . After 180 days of follow-up , aldosterone levels and PRA were significantly ( P<0.0001 ) higher in the low-sodium group . The normal-sodium group had a lower incidence of rehospitalization during follow-up and a significant decrease in plasma BNP and aldosterone levels , and PRA . The results of the present study show that a normal-sodium diet improves outcome , and sodium depletion has detrimental renal and neurohormonal effects with worse clinical outcome in compensated CHF patients . Further studies are required to determine if this is due to a high dose of diuretic or the low-sodium diet BACKGROUND Few trials have evaluated the effects of reduced sodium intake in older individuals , and no trial has examined the effects in relevant subgroups such as African Americans . PATIENTS AND METHODS The effects of sodium reduction on blood pressure ( BP ) and hypertension control were evaluated in 681 patients with hypertension , aged 60 to 80 years , r and omly assigned to a reduced sodium intervention or control group . Participants ( 47 % women , 23 % African Americans ) had systolic BP less than 145 mm Hg and diastolic BP less than 85 mm Hg while taking 1 antihypertensive medication . Three months after the start of intervention , medication was withdrawn . The primary end point was occurrence of an average systolic BP of 150 mm Hg or more , an average diastolic BP of 90 mm Hg or more , the resumption of medication , or a cardiovascular event during follow-up ( mean , 27.8 months ) . RESULTS Compared with control , mean urinary sodium excretion was 40 mmol/d less in the reduced sodium intervention group ( P<.001 ) ; significant reductions in sodium excretion occurred in subgroups defined by sex , race , age , and obesity . Prior to medication withdrawal , mean reductions in systolic and diastolic BPs from the reduced sodium intervention , net of control , were 4.3 mm Hg ( P<.001 ) and 2.0 mm Hg ( P = .001 ) . During follow-up , an end point occurred in 59 % of reduced sodium and 73 % of control group participants ( relative hazard ratio = 0.68 , P<.001 ) . In African Americans , the corresponding relative hazard ratio was 0.56 ( P = .005 ) ; results were similar in other subgroups . In dose-response analyses , end points were progressively less frequent with greater sodium reduction ( P for trend = .002 ) . CONCLUSION A reduced sodium intake is a broadly effective , nonpharmacologic therapy that can lower BP and control hypertension in older individuals This study presents an extensive analysis of the effects on blood pressure ( BP ) of changes in sodium intake over a wide array of subgroups , including joint subgroups defined by age and hypertension status , race or ethnicity and hypertension status , and gender and race or ethnicity . Participants were given 3 levels of sodium ( 50 , 100 , and 150 mmol/2,100 kcal ) for 30 days while consuming the Dietary Approaches to Stop Hypertension ( DASH ) diet ( rich in fruits , vegetables , and low-fat dairy ) or a more typical American diet . Within each diet and subgroup , there was a general pattern such that the lower the sodium level , the greater the mean reduction in BP . Sodium reduction from 100 to 50 mmol/2,100 kcal generally had twice the effect on BP as reduction from 150 to 100 mmol/2,100 kcal . Age had a strong and grade d influence on the effect of sodium within the typical and DASH diets , respectively : -4.8 and -1.0 mm Hg systolic for 23 to 41 years , -5.9 and -1.8 mm Hg for 42 to 47 years , -7.5 and -4.3 mm Hg for 48 to 54 years , and -8.1 and -6.0 mm Hg for 55 to 76 years . The influence of age on the effect of sodium reduction was particularly strong in nonhypertensive patients : -3.7 mm Hg systolic for < 45 years and -7.0 mm Hg for > 45 years with the typical diet and -0.7 and -2.8 mm Hg with the DASH diet . Reduced sodium intake and the DASH diet should be advocated for the prevention and treatment of high BP , particularly because the benefits to BP strengthen as subjects enter middle age , when the rate of cardiovascular disease increases sharply Computer simulations have been used to estimate the mortality benefits from population -wide reductions in dietary sodium , although comparisons of these estimates have not been rigorously evaluated . We used 3 different approaches to model the effect of sodium reduction in the US population over the next 10 years , incorporating evidence for direct effects on cardiovascular disease mortality ( method 1 ) , indirect effects mediated by blood pressure changes as observed in r and omized controlled trials of antihypertension medications ( method 2 ) , or epidemiological studies ( method 3).The 3 different modeling approaches were used to model the same scenarios : scenario A , gradual uniform reduction totaling 40 % over 10 years ; scenario B , instantaneous 40 % reduction in sodium consumption sustained for 10 years to achieve a population -wide mean of 2200 mg/d ; and scenario C , instantaneous reduction to 1500 mg sodium per day sustained for 10 years . All 3 methods consistently show a substantial health benefit for reductions in dietary sodium under each of the 3 scenarios tested . A gradual reduction in dietary sodium over the next decade ( scenario A ) as might be achieved with a range of proposed public health interventions would yield considerable health benefits over the next decade , with mean effects across the 3 models ranging from 280 000 to 500 000 deaths averted . Projections of instantaneous reductions illustrate the maximum benefits that could be achieved ( 0.7–1.2 million deaths averted in 10 years ) . Under 3 different modeling assumptions , the projected health benefits from reductions in dietary sodium are substantial BACKGROUND The effect of dietary composition on blood pressure is a subject of public health importance . We studied the effect of different levels of dietary sodium , in conjunction with the Dietary Approaches to Stop Hypertension ( DASH ) diet , which is rich in vegetables , fruits , and low-fat dairy products , in persons with and in those without hypertension . METHODS A total of 412 participants were r and omly assigned to eat either a control diet typical of intake in the United States or the DASH diet . Within the assigned diet , participants ate foods with high , intermediate , and low levels of sodium for 30 consecutive days each , in r and om order . RESULTS Reducing the sodium intake from the high to the intermediate level reduced the systolic blood pressure by 2.1 mm Hg ( P<0.001 ) during the control diet and by 1.3 mm Hg ( P=0.03 ) during the DASH diet . Reducing the sodium intake from the intermediate to the low level caused additional reductions of 4.6 mm Hg during the control diet ( P<0.001 ) and 1.7 mm Hg during the DASH diet ( P<0.01 ) . The effects of sodium were observed in participants with and in those without hypertension , blacks and those of other races , and women and men . The DASH diet was associated with a significantly lower systolic blood pressure at each sodium level ; and the difference was greater with high sodium levels than with low ones . As compared with the control diet with a high sodium level , the DASH diet with a low sodium level led to a mean systolic blood pressure that was 7.1 mm Hg lower in participants without hypertension , and 11.5 mm Hg lower in participants with hypertension . CONCLUSIONS The reduction of sodium intake to levels below the current recommendation of 100 mmol per day and the DASH diet both lower blood pressure substantially , with greater effects in combination than singly . Long-term health benefits will depend on the ability of people to make long-lasting dietary changes and the increased availability of lower-sodium foods 31 patients with a diastolic blood-pressure between 95 and 109 mm Hg have been treated for two years with a regimen involving a moderate restriction of salt in the diet . The results are compared with those in a control group and in a drug-treated group . Salt restriction has reduced the diastolic blood-pressure by 7.3+/-1.6 mm Hg , a result similar to that in patients treated with antihypertensive drugs . In the untreated group the diastolic blood-pressure rose by 1.8+/-1.1 mm Hg . Most patients did not achieve the desired amount of salt restriction and a stricter adherence to the diet might have caused further falls in blood-pressure . Excessive salt intake is probably a major cause of the epidemic of hypertension in " civilised " countries and a reduction in salt intake may help to control the epidemic . In persons with a diastolic blood-pressure between
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| The relationship of blood pressure ( BP ) with stroke is direct and progressive throughout the range of usual BP , starting at a level of ≈115/75 mm Hg.4 It has been estimated that elevated BP accounts for 54 % of stroke and 47 % of coronary heart disease events.5 It is noteworthy that about half of these events occur in persons without hypertension . |
MS211836 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Objective To determine whether mobile phone based monitoring improves asthma control compared with st and ard paper based monitoring strategies . Design Multicentre r and omised controlled trial with cost effectiveness analysis . Setting UK primary care . Participants 288 adolescents and adults with poorly controlled asthma ( asthma control question naire ( ACQ ) score ≥1.5 ) from 32 practice s. Intervention Participants were central ly r and omised to twice daily recording and mobile phone based transmission of symptoms , drug use , and peak flow with immediate feedback prompting action according to an agreed plan or paper based monitoring . Main outcome measures Changes in scores on asthma control question naire and self efficacy ( knowledge , attitude , and self efficacy asthma question naire ( KASE-AQ ) ) at six months after r and omisation . Assessment of outcomes was blinded . Analysis was on an intention to treat basis . Results There was no significant difference in the change in asthma control or self efficacy between the two groups ( ACQ : mean change 0.75 in mobile group v 0.73 in paper group , mean difference in change −0.02 ( 95 % confidence interval −0.23 to 0.19 ) ; KASE-AQ score : mean change −4.4 v −2.4 , mean difference 2.0 ( −0.3 to 4.2 ) ) . The numbers of patients who had acute exacerbations , steroid courses , and unscheduled consultations were similar in both groups , with similar healthcare costs . Overall , the mobile phone service was more expensive because of the expenses of telemonitoring . Conclusions Mobile technology does not improve asthma control or increase self efficacy compared with paper based monitoring when both groups received clinical care to guidelines st and ards . The mobile technology was not cost effective . Trial registration Clinical Trials NCT00512837 The self-management of asthma can improve clinical outcomes . Recently , mobile telephones have been widely used as an efficient , instant personal communication tool . This study investigated whether a self-care system will achieve better asthma control through a mobile telephone-based interactive programme . This was a prospect i ve , controlled study in outpatient clinics . From 120 consecutive patients with moderate-to-severe persistent asthma , 89 were eventually recruited for the study , with 43 in the mobile telephone group ( with a mobile telephone-based interactive asthma self-care system ) . In the mobile telephone group , mean±sem peak expiratory flow rate significantly increased at 4 ( 378.2±9.3 L·min−1 ; n = 43 ; p = 0.020 ) , 5 ( 378.2±9.2 L·min−1 ; n = 43 ; p = 0.008 ) and 6 months ( 382.7±8.6 L·min−1 ; n = 43 ; p = 0.001 ) compared to the control group . Mean±sem forced expiratory volume in 1 s significantly increased at 6 months ( 65.2±3.2 % predicted ; n = 43 ; p<0.05 ) . Patients in the mobile telephone group had better quality of life after 3 months , as determined using the Short Form-12 ® physical component score , and fewer episodes of exacerbation and unscheduled visits than the control group . Patients in the mobile telephone group significantly increased their mean daily dose of either systemic or inhaled corticosteroids compared with the control group . The mobile telephone-based interactive self-care system provides a convenient and practical self-monitoring and -management of asthma , and improves asthma control BACKGROUND For children younger than 12 years old with asthma , there are several quality -of-life instruments , clinical diaries , and question naires assessing symptoms ; however , a vali date d tool for assessing asthma control is currently lacking . OBJECTIVE To develop and vali date the Childhood Asthma Control Test ( C-ACT ) , a self-administered tool for identifying children aged 4 - 11 years whose asthma is inadequately controlled . METHODS A 21-item question naire was administered to 343 patients with asthma and their caregivers , r and omly assigning 75 % ( n = 257 ) for development and cross-sectional validation of the tool and 25 % ( n = 86 ) to a confirmatory sample . Stepwise logistic regression was used to reduce the 21 items to those best able to discriminate control as defined by the specialist 's rating of asthma control . RESULTS Seven items were selected from regression analyses of the development sample to comprise the C-ACT . The scores of each item were summed for a total score ( 0 - 27 ) , with lower scores indicating poorer control . Summed scores discriminated between groups of patients differing in the specialists ' rating of asthma control ( F = 36.89 ; P < .0001 ) , the need for change in patients ' therapy ( F = 20.07 ; P < .0001 ) , and % predicted FEV(1 ) ( F = 2.66 ; P = .0494 ) . A score of 19 indicated inadequately controlled asthma ( specificity 74 % , sensitivity 68 % ) . These analyses were confirmed in the confirmatory sample . CONCLUSION The C-ACT is a vali date d tool to assess asthma control and identify children with inadequately controlled asthma . CLINICAL IMPLICATION S The C-ACT can be valuable in clinical practice and research based on its validation , ease of use , input from the child and caregiver , and alignment with asthma guidelines
Output:
| Conclusions No apps for people with asthma combined reliable , comprehensive information about the condition with supportive tools for self-management .
There remains much to be done if apps are to find broad use in clinical practice ; clinicians can not recommend tools that are inaccurate , unsafe or lack an evidence base |
MS211837 | ***TASK*** the task is to summarize an input biomedical literature 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 : Information on major harms of medical interventions comes primarily from epidemiologic studies performed after licensing and marketing . Comparison with data from large-scale r and omized trials is occasionally feasible . We compared evidence from r and omized trials with that from epidemiologic studies to determine whether they give different estimates of risk for important harms of medical interventions . Methods : We targeted well-defined , specific harms of various medical interventions for which data were already available from large-scale r and omized trials ( > 4000 subjects ) . Nonr and omized studies involving at least 4000 subjects addressing these same harms were retrieved through a search of MEDLINE . We compared the relative risks and absolute risk differences for specific harms in the r and omized and nonr and omized studies . Results : Eligible nonr and omized studies were found for 15 harms for which data were available from r and omized trials addressing the same harms . Comparisons of relative risks between the study types were feasible for 13 of the 15 topics , and of absolute risk differences for 8 topics . The estimated increase in relative risk differed more than 2-fold between the r and omized and nonr and omized studies for 7 ( 54 % ) of the 13 topics ; the estimated increase in absolute risk differed more than 2-fold for 5 ( 62 % ) of the 8 topics . There was no clear predilection for r and omized or nonr and omized studies to estimate greater relative risks , but usually ( 75 % [ 6/8 ] ) the r and omized trials estimated larger absolute excess risks of harm than the nonr and omized studies did . Interpretation : Nonr and omized studies are often conservative in estimating absolute risks of harms . It would be useful to compare and scrutinize the evidence on harms obtained from both r and omized and nonr and omized studies Background We aim ed to determine the representation of elderly people in published reports of r and omized controlled trials ( RCTs ) . We focused on trials of 4 medications — pioglitazone , rosuvastatin , risedronate , and valsartan — frequently used by elderly patients with chronic medical conditions . Methods and Findings We selected all reports of RCTs indexed in PubMed from 1966 to April 2008 evaluating one of the 4 medications of interest . Estimates of the community-based “ on-treatment ” population were from a national health insurance data base ( SNIIR-AM ) covering approximately 86 % of the population in France . From this data base , we evaluated data cl aims from January 2006 to December 2007 for 1,958,716 patients who received one of the medications of interest for more than 6 months . Of the 155 RCT reports selected , only 3 studies were exclusively of elderly patients ( 2 assessing valsartan ; 1 risedronate ) . In only 4 of 37 reports ( 10.8 % ) for pioglitazone , 4 of 22 ( 18.2 % ) for risedronate , 3 of 29 ( 10.3 % ) for rosuvastatine and 9 of 67 ( 13.4 % ) for valsartan , the proportion of patients aged 65 or older was within or above that treated in clinical practice . In 62.2 % of the reports for pioglitazone , 40.9 % for risedronate , 37.9 % for rosuvastatine , and 70.2 % for valsartan , the proportion of patients aged 65 or older was lower than half that in the treated population . The representation of elderly people did not differ by publication date or sample size . Conclusions Elderly patients are poorly represented in RCTs of drugs they are likely to receive Context Prescription and management of medications are important issues for older adults . Contribution Among elders enrolled in two managed care organizations , most quality problems were related to failure to prescribe indicated medications ; failure to monitor medications ; and failure to provide medication along with proper documentation and education in concert with other physicians . Implication s Prescribing inappropriate medications for older adults is less of an issue than other aspects of drug therapy . Quality improvement efforts should focus on avoiding errors of omission in prescribing indicated medications , monitoring , patient education , and follow-up . The Editors Pharmacotherapy is an essential component of medical treatment for older patients , but medications are also responsible for many adverse events in this group . Ninety percent of people 65 years of age or older take at least one medication ( 1 ) . This age group , which represents only 13 % of the population , accounts for one third of all prescription drug expenditures in the United States ( 2 ) . Many older persons take multiple drugs for the treatment of several conditions , which increases the chance of adverse drug reactions , drugdrug interactions , and drugdisease interactions . The frequency of adverse drug events in elderly out patients ranges from 10 % to 35 % , depending on the setting ( 3 - 5 ) . Recognizing the magnitude of medication-related issues , panels of geriatric experts rate medication problems among the most important quality -of-care problems for older patients ( 6 - 8 ) . Reflecting the severity and frequency of adverse drug events in older patients , many investigations have focused on the appropriateness of medication prescribing to elderly persons . Implicit review mechanisms include the Medication Appropriateness Index , which consists of 10 medication characteristics ( including indication , effectiveness , and dosage ) that a trained pharmacist review er can judge as appropriate , marginally appropriate , or inappropriate . An application of the Medication Appropriateness Index to elderly veterans taking 5 or more prescription medications found that 74 % had at least 1 inappropriate aspect to their prescriptions ( 9 , 10 ) . Review s using explicit criteria usually focus on medications that should be avoided in the care of older patients . The list of medications to avoid , which was developed by Beers and colleagues on the basis of a formal consensus of geriatric experts ( 11 - 13 ) , has been applied to various groups of patients , revealing a high prevalence of inappropriate drug use ( 14 - 20 ) . In addition , explicit criteria about drugdrug interactions , treatment duration , and drug contraindications were created by Tamblyn and colleagues and applied to medications prescribed to older patients in Canada ( 21 ) . They found that more than half of older patients took at least one high-risk medication . Health policy efforts , on the other h and , have focused predominantly on finding ways to pay for the medication needed by older patients . Proposals aim to improve access to pharmacologic care but do not strive to develop mechanisms to evaluate or improve the quality of medication management for older patients . Improvement in access to medications without quality assurance may result in a mere increase in care without change in outcomes . To provide a more comprehensive evaluation of the quality of pharmacologic care for older patients , we systematic ally evaluated medication management for a sample of older patients by taking advantage of a set of explicit process of care quality indicators developed and implemented in the Assessing Care of Vulnerable Elders ( ACOVE ) project ( 22 ) . Whereas the earlier ACOVE analysis described overall quality of care and compared care quality for geriatric and medical conditions , this study focuses on pharmacologic care and identifies improvement needs in medication management . Our quality evaluation covered the continuum of pharmacologic care , from recognizing the indications for medications to choosing medication , prescribing appropriately , educating and documenting , and monitoring after prescribing . Methods The ACOVE project developed a set of explicit quality indicators to evaluate the care provided to vulnerable older persons ( 22 - 24 ) . The system focuses on processes of care within the domains of prevention , diagnosis , treatment , and follow-up and covers the spectrum of care contained in 22 conditions that are important in the care of older patients ( 7 ) . The methods for selecting conditions and developing the quality indicators are described in detail elsewhere ( 7 , 23 ) . Methods included systematic literature review s and multiple layers of expert judgment ( 23 ) . The literature review result ed in proposal of c and i date quality indicators , which were review ed by an expert panel that rated each of the proposed quality indicators for validity and feasibility . This set was modified and approved by a clinical committee of national geriatric experts and by the American College of Physicians Task Force on Aging ( 24 ) . From the final ACOVE set of quality indicators , 43 quality indicators ( Table 1 and Appendix Table ) that pertained to pharmacologic care and had more than 5 eligible patients are included in this analysis . Table 1 . Medication Quality Indicators , Number of Eligible Patients , and Pass Rates Patients and Data Collection We assessed care provided to older persons who were enrolled in 2 managed care organizations . Each managed care organization , one in the U.S. Northeast and the other in the Southwest , had more than 20 000 senior enrollees and contracted with a network of providers to deliver care . A r and om sample of community-dwelling persons 65 years of age or older was drawn from enrollees in each managed care organization . Eligibility criteria included continuous enrollment in the managed care organization for at least 13 months , no out-of-plan care , and no active treatment for malignant conditions ( excluding nonmelanoma skin cancer ) during the period . In addition , persons who did not speak English were excluded because our interview instruments were not available in other language s. Among the enrollees , we targeted vulnerable elders , defined as persons 65 years of age and older who are at increased risk for death or functional decline . Vulnerable elders were identified on the basis of self-report ( or proxy report ) by using a brief screening survey ( the Vulnerable Elders-13 [ VE-13 ] Survey [ 25 ] ) administered by telephone . The R AND Institutional Review Board approved the study protocol . Data were derived mainly from abstract ing medical records . For participating patients , we identified all inpatient and outpatient medical records during the 13-month period of 1 July 1998 to 31 July 1999 . These medical records were abstract ed by trained nurses with experience in quality assessment . The abstract or considered all of a patient 's medical records when assessing whether a patient was eligible for and received the indicated care processes . Information on eligibility for a quality indicator could be derived from one medical record ( such as a primary care physician starting an appropriate antidepressant ) and the care process delivered and documented from records in another setting ( such as a psychiatric consultant escalating the antidepressant dosage in response to lack of improvement ) . A senior nurse- review er assessed each completed medical record abstract , and physician overreaders review ed quality indicators that required a clinical assessment , such as whether there was follow-up to newly started long-term therapy with a medication or whether newly started therapy with a highly anticholinergic drug had acceptable alternatives . We evaluated inter-rater reliability by re- abstract ing a r and om sample of 10 % of the medical records . These records contained 698 quality indicators ; 97 % had identical eligibility and 95 % demonstrated identical eligibility and score . Details of study enrollment and data collection can be found elsewhere ( 22 ) . Because some aspects of care might not be adequately captured in the medical record ( for example , patient education about medications ) , these data were supplemented by a quality -of-care interview with study participants ( or , if necessary , their proxies ) . During the interview , patients were asked to list all of their medications . On the basis of conditions and medications reported during the interview , patients were asked about specific processes of care they had received . The interview was conducted by telephone between August and October 2000 . To minimize recall bias , we asked about most recent care when implementing quality indicators that may include multiple events ( for example , education about newly started therapy with a medication ) . Information was obtained from medical records for 37 quality indicators and from the patient interview for 6 quality indicators . For 4 quality indicators reported previously by using medical record data ( 22 ) , we used interview data in this analysis because subsequent evaluation revealed that interview data on information transfer quality indicators yielded higher pass rates that were aligned with a priori hypotheses and provided more conservative estimates of quality of care . Statistical Analysis A quality indicator was scored for a patient if he or she met the eligibility criteria to receive the specified care process . The quality indicator was passed if the care process was implemented for the patient . If the medical record indicated that the patient declined the care process , the quality indicator was considered to be passed . On the other h and , if the patient had a prespecified contraindication to the care process ( such as a patient with asthma who otherwise was eligible to receive a -blocker after a myocardial infa rct ion ) , the patient was considered ineligible for the quality indicator . Quality scores were calculated as the proportion of eligible patients who received indicated care . 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 Frail older people have been systematic ally excluded from r and omised controlled trials ( RCT ) . We aim to recruit older , frail hospitalised patients in an RCT and evaluate the frailty index ( FI ) as a measure to describe the types of people included in the study . We recruited 315 hospitalised patients aged 65 years ; age ranged from 60 to 102 years . Baseline assessment scores ranged as follow : Mini‐Mental Status Examination from 7 to 30 , Barthel index from 5 to 100 and FI from 2 to 24 . Total deaths were 20 ( 6 % ) . We demonstrated that it is feasible to recruit frail older people into RCTs . The FI does not show any ‘ floor ’ or ‘ ceiling ’ effects . We can measure frailty in an RCT cohort , and we believe that clinical trials should include more frail older people and that the use of an FI can facilitate such trials and generate reliable data to guide future medical practice in a rapidly ageing society CONTEXT R and omized trials with adequate sample size offer an opportunity to assess the safety of new medications in a controlled setting ; however , general
Output:
| CONCLUSIONS The efficacy of pharmacologic treatments did not significantly differ , on average , between RCTs including older adults only and RCTs of all adults . |
MS211838 | ***TASK*** the task is to summarize an input biomedical literature 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: Recent re-evaluation of preventive health care has result ed in more limited and directed guidelines ; nonetheless , physician compliance has remained poor . This study assessed whether an inexpensive reminder system of preventive care checklists would improve physician implementation of periodic health measures . Residents in internal medicine were r and omly placed into two groups : one received a copy of the appropriate checklist with each patient 's medical record ; the other did not . After one year , 200 r and omly selected records were audited to determine the proportion of recommendations implemented for each patient . Residents who received checklists performed appropriate preventive health measures at a significantly higher rate than those who did not ( 0.56 + /- 0.26 versus 0.39 + /- 0.22 , p less than 0.002 ) . The actual use of the checklist to record the results was associated with an even higher rate of compliance compared with instances in which the checklists were provided but not used and instances in which checklists were not received ( 0.70 + /- 0.21 versus 0.44 + /- 0.24 and 0.39 + /- 0.22 , respectively , p less than 0.002 ) . These data suggest that a physician 's use of simple checklists can provide an inexpensive and effective means of improving implementation of periodic health maintenance We developed a computer-stored medical record system containing a limited set of the total clinical data base -- primarily diagnostic studies and treatments . This system responds to its own content according to physician-authored reminder rules . To determine the effect of the reminder messages generated by 1490 rules on physician behavior , we r and omly assigned practitioners in a general medicine clinic to study or control groups . The computer found indications for six different actions per patient in 12 467 patients during a 2-year study : 61 study group residents who received computer reminders responded to 49 % of these indications ; 54 control group residents , to only 29 % ( p less than 0.0001 ) . Preventive care ( occult blood testing , mammographic screening , weight reduction diets , influenza and pneumococcal vaccines ) was affected . The intentions of the study group to use a given action for an indication predicted their response to the indications ( p less than 0.03 , r2 = 0.33 ) . The intentions of the control residents did not In an academic general medicine clinic , we performed a r and omized , controlled trial to compare ( 1 ) the effects of supplying monthly feedback reports of compliance with preventive care protocol s by 135 internal medicine house staff with ( 2 ) the effects of specific reminders given to them at the time of patient visits . The protocol s were r and omly divided into two groups , A and B , and half the house staff were given feedback for Group A and half for Group B. Thus , each group served as a control for the other . Each feedback group was also r and omly assigned to receive reminders for either Group A or B protocol s. House staff receiving feedback more often complied with fecal occult blood testing , mammography , pneumococcal vaccination , use of metronidazole , and combined Group A and B protocol s than did controls ( P < 0.01 ) . There was also significantly more compliance with the same protocol s by house staff receiving reminders , but the increase for fecal occult blood testing , pneumococcal vaccination , and combined Group A protocol s was twice that seen in physicians given feedback alone . In addition , reminders alone increased compliance with oral calcium supplementation . Overall compliance with the preventive care protocol s was low : 10 - 15 % in physicians receiving neither feedback nor reminders , increasing to 15 - 30 % in those receiving reminders . Physician compliance with suggested preventive care protocol s can be increased by both delayed feedback and immediate reminders , but reminders have a greater effect OBJECTIVE --To discover whether systematic methods of call and recall are more effective than a non- systematic method and to see which of the two systematic methods was more effective . DESIGN -- Prospect i ve r and omised controlled trial over a year . SETTING --One group general practice . PATIENTS --416 Women over 35 eligible for a smear test who had never had a cervical smear test or in whom a smear test was overdue ( previous test more than five years before ) . INTERVENTIONS --One group received written invitations to have a smear taken . The second group had their notes tagged so that the doctor would remind them ( when they attended for another reason ) to have a smear test . No special intervention was made in the third group . MAIN OUTCOME MEASURE -- Performance of a cervical smear test during the year of the study . RESULTS --32 % ( 45/140 ) of the screened group , 27 % ( 39/142 ) of the tagged group , and 15 % ( 20/134 ) of the control group had a smear test during the year . The percentage of women having a smear test in the screened group was not significantly different from that in the tagged group , but the percentages in the two groups were significantly different from that in the control group . Whether a woman had had a previous smear test significantly affected the uptake of the invitation to have a smear test independently of the method of invitation . CONCLUSIONS --The systematic methods of call and recall were more effective than a non- systematic method . There was no significant difference between the two systematic methods ( sending letters or tagging the notes ) at one year Objective : To improve the delivery of preventive care in a medical clinic , a controlled trial was conducted of two interventions that were expected to influence delivery of preventive services differently , depending on level of initiative required of the physician or patient to complete a service . Design : A prospect i ve , controlled trial of five-months ’ duration . Setting : A university hospital-based , general medical clinic . Participants : Thirty-nine junior and senior medical residents who saw patients in stable clinic teams throughout the study .Intervention : A computerized reminder system for physicians and a patient question naire and educational h and out on preventive care . Measurements and main results : Delivery of five of six audited preventive services improved significantly after the interventions were introduced . The computerized reminder alone increased completion rates of services that relied primarily on physician initiative ; the question naire alone increased completion rate of the service that depended more on patient compliance as well as on some physician-dependent services . Both interventions used together were slightly less effective in improving performance of physician-dependent services than the computerized reminder used alone . Conclusions : These interventions can improve the delivery of preventive care but they differ in their impacts on physician and patient behaviors . Overall , the computer reminder was the more effective intervention BACKGROUND We compared the efficacy of a computer-generated prompt sheet placed on the front of patients ' charts with a patient-carried prompt card to remind physicians to perform selected health maintenance items . METHODS A r and omized prospect i ve single-blind study was performed in private practice offices in rural eastern North Carolina , with 28 family practitioners and nine general internists participating . Twenty-two physicians were r and omized to the computer prompt group and 22 to the card prompt group . Four physicians in the computer group did not complete the study because of computer software problems , and three physicians did not complete the study because their limited staff was unable to enter patient data into the computer . Before the intervention , 20 patient charts ( 10 males and 10 females ) from each physician were audited for the performance of influenza vaccinations , stool for occult blood , pap smears , breast examinations performed by the physicians , and mammograms . One year after the intervention was instituted , chart audits for the above five items were done again on 20 different patient charts for each physician . RESULTS There was a 7 % increase in the performance of influenza vaccinations in the card group ( 17 % vs 24 % ) compared with a 6 % increase in the computer group ( 20 % vs 26 % ) . There was a 5 % decrease in the performance of stool for occult blood in the card group ( 28 % vs 23 % ) compared with a 1 % increase in the computer group ( 30 % vs 31 % ) . There was an 11 % decrease in the performance of pap smears in the card group ( 26 % vs 15 % ) compared with a 3 % increase in the computer group ( 23 % vs 26 % ) . There was a 2 % decrease in the performance of breast examinations by the physician in the card group ( 35 % vs 33 % ) compared with a 3 % increase in the computer group ( 30 % vs 33 % ) . Finally , there was a 3 % increase in the performance of mammograms in the card group ( 22 % vs 25 % ) compared with an 11 % increase in the computer group ( 15 % vs 26 % ) . CONCLUSIONS Our data show a greater increase in performance of health maintenance items in the computer-prompted group . The performance of stool for occult blood , pap smears , breast examinations performed by the physician , and mammograms were increased more in the computer-prompted group than in the card group . However , there was not a statistically significant difference after intervention for any of the audited health maintenance items for either the computer group or the card group . Overall , health maintenance measures were performed in only a minority of appropriate patients To determine effective methods of promoting routine cancer screening , we r and omly assigned 62 internal medicine residents to receive cancer screening reminders ( computer-generated lists of overdue tests at patients ' visits ) , audit with feedback ( monthly seminars about screening , with feedback about their performance rates ) , or no intervention ( controls ) . Half of the residents in each group also were r and omized to receive patient education ( patients received literature and notices of overdue tests ) . We review ed a sample of each physician 's medical records to assess performance of seven tests during 9-month periods before and after initiating the interventions . Cancer screening reminders increased performance of six of seven tests ; audit with feedback , four of seven tests ; and patient education , one of two targeted breast cancer screening tests . The results indicate that the cancer screening reminders strategy was the most effective in promoting the performance of routine cancer screening tests In a r and omized trial three ways of increasing rates of cervical screening were compared for women attending a family medicine center . Working from computerized medical records , 1,587 women aged 18 to 35 years who were overdue for a screening test were included in the study . In a control group , no formal method was used to encourage patients to attend for screening , and 13.7 percent obtained a test within the trial year . In one intervention group the physician was issued a message identifying those women visiting the center for a routine appointment who were due for screening ; 16.1 percent were screened . Sending a letter to patients in a second group yielded a 25.9 percent compliance rate . In a third group the practice nurse called patients on the telephone to advise them to obtain the test , and 20.0 percent complied . Reminders issued to the physician provide a low-cost , opportunistic approach to reach women who happen to visit the practice , but this approach should be supplemented by telephoning or sending a letter to those women who do not attend regularly Despite its demonstrated efficacy in reducing breast carcinoma mortality , screening mammography remains underutilized and its promotion in the primary care setting provides an important opportunity for intervention BACKGROUND Colorectal cancer is the second leading cause of cancer mortality in israel . Unfortunately , compliance with annual fecal occult blood testing is very low . OBJECTIVE To assess the effectiveness of interventions to increase FOBT screening in primary care clinics in Israel . METHODS A prospect i ve , r and omized study included all 50 - 75 year old enrollees of six family physicians in two primary care clinics . The register of two physicians , one from each clinic , was allocated to one of three groups . Two FOBT reminder strategies were tested : a physician reminder ( 753 patients ) , and a patient reminder that was either a phone call ( 312 patients ) or a letter ( 337 patients ) . The control group ( 913 patients ) of physicians continued administering their regular level of care . The main outcome measure was the percentage of patients undergoing FOBT screening in each study arm at the conclusion of the one year study period . RESULTS In the intervention groups 14.3 % ( 201/1,402 ) were screened using the FOBT over the course of the study year . Using an intent-to-screen analysis , the screening rate in the physician and patient reminder groups was significantly higher than in the control group ( 16.5 and 11.9 % , vs. 1.2 % respectively , P < 0.0001 ) . Phone reminders were significantly more effective than letters ( 14.7 vs. 9.2 % , P = 0.01 ) . CONCLUSIONS Various reminder systems for FOBT are beneficial , especially those centered around the family physician . Further research should focus on this area , in conjunction with other novel approaches Performance of health maintenance procedures by internal medicine house staff is inadequate , yet little has been published outlining means to improve performance rates . We prospect ively studied the effectiveness of a reminder system to improve screening by Pap smear , rectal examination with stool guaiac test , breast examination , and pneumococcal vaccine administration in two resident outpatient clinics . Performance of these preventive health measures was determined during a six-week baseline period and again after five months of chart reminders to residents in one clinic , and after six months without reminders . For the intervention , a physician 's assistant screened each chart and attached a reminder to the front indicating which procedures were overdue based on published recommendations . Health screening behavior was not significantly different between the two resident clinics during baseline . After the five-month reminder intervention , residents in both groups moderately increased their preventive health activities over baseline ; however , only the reminded group showed significant improvement ( chi 2 = 11.60 , P less than .001 ) . Six months after remainders were discontinued there was no difference in overall performance between the two clinics ( chi 2 = 2.79 , NS ) . The reminded group did preserve its significant improvement over the bas
Output:
| Evidence in this review of studies published from 1986 through 2004 indicates that reminder/recall systems can effectively increase screening with mammography , Pap , fecal occult blood tests , and flexible sigmoidoscopy . |
MS211839 | ***TASK*** the task is to summarize an input biomedical literature 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 . Germinated barley foodstuff ( GBF ) is a prebiotic foodstuff that effectively increases luminal butyrate production by stimulating the growth of protective bacteria . In the first pilot study , GBF has been shown to reduce both clinical activity and mucosal inflammation in ulcerative colitis ( UC ) . The aim of this study was to investigate the efficacy of GBF in the treatment of UC in a multicenter open control trial . Methods . Eighteen patients with mildly to moderately active UC were divided into two groups using a r and om allocation protocol . The control group ( n = 7 ) were given a baseline anti-inflammatory therapy for 4 weeks . In the GBF-treated group ( n = 11 ) , patients received 20–30 g GBF daily , together with the baseline treatment , for 4 weeks . The response to the treatments was evaluated clinical ly and endoscopically . Fecal micro-flora were also analyzed . Results . After 4 weeks of observation , the GBF-treated group showed a significant decrease in clinical activity index scores compared with the control group ( P < 0.05 ) . No side effects related to GBF were observed . GBF therapy increased fecal concentrations of Bifidobacterium and Eubacterium limosum . Conclusions . Oral GBF therapy may have the potency to reduce clinical activity of UC . We believe that these results support the use of GBF administration as a new adjunct therapy for UC This document represents the first collaboration between 2 organizations — the American Society for Parenteral and Enteral Nutrition and the Society of Critical Care Medicine — to describe best practice s in nutrition therapy in critically ill children . The target of these guidelines is intended to be the pediatric critically ill patient ( > 1 month and 2–3 days in a PICU admitting medical , surgical , and cardiac patients . In total , 2032 citations were scanned for relevance . The PubMed / MEDLINE search result ed in 960 citations for clinical trials and 925 citations for cohort studies . The EMBASE search for clinical trials culled 1661 citations . In total , the search for clinical trials yielded 1107 citations , whereas the cohort search yielded 925 . After careful review , 16 r and omized controlled trials and 37 cohort studies appeared to answer 1 of the 8 preidentified question groups for this guideline . We used the GRADE criteria ( Grading of Recommendations , Assessment , Objective To determine the effectiveness of increasing the dietary content of soluble fibre ( psyllium ) or insoluble fibre ( bran ) in patients with irritable bowel syndrome . Design R and omised controlled trial . Setting General practice . Participants 275 patients aged 18 - 65 years with irritable bowel syndrome . Interventions 12 weeks of treatment with 10 g psyllium ( n=85 ) , 10 g bran ( n=97 ) , or 10 g placebo ( rice flour ) ( n=93 ) . Main outcome measures The primary end point was adequate symptom relief during at least two weeks in the previous month , analysed after one , two , and three months of treatment to assess both short term and sustained effectiveness . Secondary end points included irritable bowel syndrome symptom severity score , severity of abdominal pain , and irritable bowel syndrome quality of life scale . Results The proportion of responders was significantly greater in the psyllium group than in the placebo group during the first month ( 57 % v 35 % ; relative risk 1.60 , 95 % confidence interval 1.13 to 2.26 ) and the second month of treatment ( 59 % v 41 % ; 1.44 , 1.02 to 2.06 ) . Bran was more effective than placebo during the third month of treatment only ( 57 % v 32 % ; 1.70 , 1.12 to 2.57 ) , but this was not statistically significant in the worst case analysis ( 1.45 , 0.97 to 2.16 ) . After three months of treatment , symptom severity in the psyllium group was reduced by 90 points , compared with 49 points in the placebo group ( P=0.03 ) and 58 points in the bran group ( P=0.61 versus placebo ) . No differences were found with respect to quality of life . Fifty four ( 64 % ) of the patients allocated to psyllium , 54 ( 56 % ) in the bran group , and 56 ( 60 % ) in the placebo group completed the three month treatment period . Early dropout was most common in the bran group ; the main reason was that the symptoms of irritable bowel syndrome worsened . Conclusions Psyllium offers benefits in patients with irritable bowel syndrome in primary care . Trial registration Clinical trials NCT00189033 Background and Aim Partially hydrolyzed guar gum ( PHGG ) is a water-soluble , non-gelling dietary fiber with a wide range of uses in clinical nutrition . The aim of this prospect i ve study was to investigate the effect of guar gum on colonic transit time ( CTT ) and symptoms of chronic constipation . Methods We enrolled patients fulfilling Rome III criteria for chronic constipation . CTT was measured before and at the end of treatment . After a 2-week run-in period , patients received 5 mg PHGG daily for 4 weeks . During study period , patients kept daily symptoms , stool and laxative usage diaries . They also recorded their symptom-related satisfaction weekly and treatment adverse events . Results Forty-nine patients received treatment ; 39 ( 80 % ) completed the study . Treatment significantly reduced colon transit time , from 57.28 ± 39.25 to 45.63 ± 37.27 h ( p = 0.026 ) , a reduction more prominent in slow transit patients ( from 85.50 ± 27.75 to 63.65 ± 38.11 h , p = 0.016 ) . Overall , the weekly number of complete spontaneous and spontaneous bowel movements increased significantly ( p < 0.001 ) ; the latter correlated significantly with the acceleration of CTT in the overall population and in slow transit patients ( B = 0.382 ; p = 0.016 and B = 0.483 ; p = 0.023 , respectively ) . In addition , the number of bowel movements with straining decreased ( p < 0.001 ) and stool form improved ( p < 0.001 ) , while days with laxative intake and days with abdominal pain decreased ( p = 0.001 and p = 0.027 , respectively ) . Conclusion Four-week PHGG use accelerates colon transit time in patients with chronic constipation , especially in those with slow transit , and improves many of their symptoms including frequency of bowel movements BACKGROUND AND AIMS Enteral fiber-free diets alter intestinal transit and produce diarrhea or constipation . This prospect i ve double blind , controlled study evaluates the use of guar gum , a soluble fiber and a c and i date prebiotic in enteral feeds , to prevent diarrhea and potential health benefits in intensive care unit patients . METHODS Twenty patients on enteral nutrition with persistent diarrhea were r and omized to receive a new enteral feed either enriched with 2 % soluble guar gum ( study group , n = 10 ) or fiber-free ( control group , n = 10 ) for 4 successive days . RESULTS The number of liquid stools in response to a soluble fiber-enriched diet was 2.0+/-0.9 ( first day ) vs. 1.0+/-0.7 ( fourth day ) ( P < 0.01 ) , and in the control group 1.2+/-0.7 ( first day ) vs. 2.1+/-0.8 ( fourth day ) ( P < 0.05 ) . In the fiber-enriched feed group , plasma glucose and cholesterol levels at termination of the study , respectively , reached 126+/-81 and 164+/-71 mg dl(-1 ) , as compared to 333+/-108 and 378+/-26 mg dl(-1 ) on Day first ( P < 0.01 ) . In the control group , these values on the fourth day were , respectively , 267+/-94 and 263+/-79 vs. 247+/-115 and 315+/-78 on Day first ( P > 0.05 ) . CONCLUSIONS Guar gum-enriched enteral nutrition was related to a decrease of diarrheal episodes in ICU patients with preexisting diarrhea ; and to a trend for lower plasma glucose and cholesterol levels Abstract PURPOSE : Inflammation is a constant finding in the ileal reservoir of patients with an ileal pouch-anal anastomosis and is associated with decreased fecal concentrations of the short chain fatty acid butyrate , increased fecal pH , changes in fecal flora , and increased concentrations of secondary bile acids . In healthy subjects , inulin , a dietary fiber , is fermented to short chain fatty acids and leads to a lower pH and potentially beneficial changes in fecal flora . The aim of the present study was to investigate the effect of enteral supplementation of inulin on inflammation of the ileal reservoir . METHODS : Twenty patients received 24 g of inulin or placebo daily during three weeks in a r and omized , double-blind , crossover design . Stools were analyzed after each test period for pH , short chain fatty acids , microflora , and bile acids . Inflammation was assessed endoscopically , histologically , and clinical ly . RESULTS : Compared with placebo , three weeks of dietary supplementation with 24 g of inulin increased butyrate concentrations , lowered pH , decreased numbers of Bacteroides fragilis , and diminished concentrations of secondary bile acids in feces . This was endoscopically and histologically accompanied by a reduction of inflammation of the mucosa of the ileal reservoir . CONCLUSION : Enteral inulin supplementation leads to a decrease of inflammation-associated factors and to a reduction of inflammation of pouch mucosa The effect of hydrolyzed partially guar-gum was evaluated in the treatment of functional constipation among hospitalized patients . Following a r and omized blind controlled-trial 64 adults were allocated to two groups : one received daily high-fiber diet ( approximately 30 g ) and the other similar diet plus 10 g of hydrolyzed partially guar-gum , during 15 days . Dietary fiber reduced functional constipation by 78.0 % . Hydrolyzed partially guar-gum did not show any additional effect in defecation frequency , fecal consistence , need of laxative drug use , although a reduction in bowel complaints . Dietary fiber may be used in the treatment of functional constipation . However the therapeutic role of hydrolyzed partially guar-gum should be further investigated BACKGROUND AND AIMS Attempts to control enteral nutrition associated diarrhea in the critically ill tube-fed patient by implementing feeding formulas enriched with fiber were mostly unsuccessful . Recently , it was shown that enteral feeding containing soluble partially hydrolyzed guar decreased the incidence of diarrhea in a cohort of non-critically ill medicosurgical patients . We investigated whether this type of enteral feed could also influence stool production in patients with severe sepsis , a population at risk for developing diarrhea . METHODS The study was double-blind . Patients with severe sepsis and septic shock were consecutively enrolled and at r and om received either an enteral formula supplemented with 22 g/l partially hydrolyzed guar or an isocaloric isonitrogenous control feed without fiber . All patients were mechanically ventilated and treated with catecholamines and antibiotics . Enteral feeding was provided through a nasogastric tube for a minimum of 6 days . A semiquantitative score based on stool volume and consistency was used for daily assessment of diarrhea . RESULTS 25 patients fulfilled the criteria for data analysis . Soluble fiber was administered in 13 of them . The two groups were well-matched for gender , age , disease severity , cause of sepsis , laboratory parameters , total feeding days and time to reach nutritional goals . The mean frequency of diarrhea days was significantly lower in patients receiving fiber than in those on st and ard alimentation ( 8.8+/-10.0 % vs 32.0+/-15.3 % ; P=0.001 ) . The whole group of fiber-fed patients had less days with diarrhea per total feeding days ( 16/148 days ( 10.8 % ) vs 46/146 days ( 31.5 % ) ; P<0.001 ) and a lower mean diarrhea score ( 4.8+/-6.4 vs 9.4+/-10.2 ; P<0.001 ) . The type of enteral diet did not influence sepsis-related mortality and duration of stay in the intensive care unit . CONCLUSION Total enteral nutrition supplemented with soluble fiber is beneficial in reducing the incidence of diarrhea in tube-fed full-resuscitated and mechanically ventilated septic patients OBJECTIVE Butyrate enemas may be effective in the treatment of active distal ulcerative colitis . Because colonic fermentation of Plantago ovata seeds ( dietary fiber ) yields butyrate , the aim of this study was to
Output:
| Conclusions : GGPH is useful in the management of enteral nutrition associated diarrhea . |
MS211840 | ***TASK*** the task is to summarize an input biomedical literature 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 : Pain following spinal cord injury ( SCI ) is a therapeutic challenge . Only a few treatments have been assessed in r and omized , controlled trials . The primary objective of the present study was to examine the analgesic effect of ketamine and lidocaine in a group of patients with neuropathic pain below the level of spinal cord injury . We also wanted to assess sensory abnormalities to see if this could help us to identify responders and if treatments result ed in changes of sensibility OBJECTIVES Complex regional pain syndrome ( CRPS ) , formerly known as reflex sympathetic dystrophy ( RSD ) , is a painful , disabling disorder for which treatment is difficult . The aim of this study was to determine the efficacy of pamidronate in a double-blind r and omized placebo-controlled trial . METHODS Patients referred to our regional multidisciplinary pain management center who fulfilled the International Association for the Study of Pain criteria for CRPS Type I were enrolled in the study over a 2-year period . Patients were administered , intravenously , either pamidronate , 60 mg as a single dose , or normal saline . Patients ' pain scores , global assessment of disease severity scores , and functional assessment ( SF-36 ) scores were documented at baseline and at 1 and 3 months . RESULTS Twenty-seven patients ( 18 female , 9 male ; average age 45 years ) were recruited , of whom 14 received pamidronate and 13 received placebo . Overall improvements in pain score , patient 's global assessment of disease severity score , and physical function ( SF-36 ) score were noted in the pamidronate group at 3 months , and improvements in role physical ( SF-36 ) score were noted at 1 and 3 months . There was variability in pamidronate response among individuals . CONCLUSIONS Pamidronate may be a useful treatment option in the management of patients with CRPS Type I. Although treatment response was variable , the majority of patients improved . Early administration in t and em with other treatment measures is recommended Background : The mechanisms underlying neuropathic pain are incompletely understood . Targeting specific molecular mechanisms in the pain signaling system may assist in underst and ing key features in neuropathic pains such as allodynia . This study examined the effect of systemically administered ketamine , an N-methyl-d-aspartate receptor antagonist and lidocaine , a sodium channel blocker , on spontaneous pain , brush-evoked pain , and pinprick-evoked pain in patients with nerve injury pain . Methods : Twenty patients participated in two r and omized , double-blinded , placebo-controlled , crossover experiments in which they , on four different days , received a 30-minute intravenous infusion of ketamine ( 0.24 mg/kg ) , lidocaine ( 5 mg/kg ) , or saline . Ongoing pain , pain evoked by brush and repetitive pinprick stimuli , and acetone was measured before , during , and after infusion . Results : Ketamine significantly reduced ongoing pain and evoked pain to brush and pinprick , whereas lidocaine only reduced evoked pain to repetitive pinprick stimuli . In individual patients , there was no correlation between the pain-relieving effect of lidocaine and ketamine on ongoing or mechanically evoked pains . Conclusions : N-methyl-d-aspartate receptor-linked systems and sodium channels are involved in generation and maintenance of pain in patients with peripheral nerve injury . It is likely that ongoing pain as well as mechanical hyperalgesia in individual patients is dependent on several separate molecular mechanisms Study Design . A r and omized , controlled , double-blind trial . Objective . To assess the effectiveness of fluoroscopically directed caudal epidural injections in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis with local anesthetic with or without steroids . Summary of Background Data . The available literature on the effectiveness of epidural injections in managing chronic low back pain secondary to disc herniation is highly variable . Methods . One hundred twenty patients suffering with low back and lower extremity pain with disc herniation and radiculitis were r and omized to one of the two groups : group I received caudal epidural injections with an injection of local anesthetic , lidocaine 0.5 % , 10 mL ; group II patients received caudal epidural injections with 0.5 % lidocaine , 9 mL , mixed with 1 mL of steroid . The Numeric Rating Scale ( NRS ) , the Oswestry Disability Index 2.0 ( ODI ) , employment status , and opioid intake were utilized with assessment at 3 , 6 , and 12 months posttreatment . Results . The percentage of patients with significant pain relief of 50 % or greater and /or improvement in functional status with 50 % or more reduction in ODI scores was seen in 70 % and 67 % in group I and 77 % and 75 % in group II with average procedures per year of 3.8 ± 1.4 in group I and 3.6 + 1.1 in group II . However , the relief with first and second procedures was significantly higher in the steroid group . The number of injections performed was also higher in local anesthetic group even though overall relief was without any significant difference among the groups . There was no difference among the patients receiving steroids . Conclusion . Caudal epidural injection with local anesthetic with or without steroids might be effective in patients with disc herniation or radiculitis . The present evidence illustrates potential superiority of steroids compared with local anesthetic at 1-year follow-up Background and objective To investigate the effect of intravenous regional anesthesia ( Bier block ) with methylprednisolone and lidocaine in complex regional pain syndrome ( CRPS ) type I in a r and omized , double-blinded , and placebo-controlled study . Methods Twenty-two patients with the diagnosis of CRPS of their upper limb were divided r and omly into 2 groups . The mean age was 22.3 ±1.6 years . Average pain duration was 3.1 ± 1.4 months . In the placebo group ( 10 patients ) , patients received only 100 mL of saline . In the study group ( 12 patients ) , 40 mg of methylprednisolone and 10 mL of 2 % lidocaine were added to the saline . Treatments were applied once a week . Unless significant adverse effects occurred , 3 sessions of blockade were completed . Pain severity , range of motion ( ROM ) , and volumetric edema measurements were obtained before treatment . Pain severity and satisfaction ( resolved , better , no change , or worse ) were recorded after each session . The final assessment was performed 1.5 months later . ROM and volumetric measurements were repeated the day after the block and at the final assessment . Results Differences in pretreatment features of the patients were not statistically significant ( P > .05 ) . In all assessment periods during the study , improvement in pain severity was statistically significant ( P < .05 ) in both groups . This statistically significant difference disappeared at the final assessment ( P > .05 ) . No statistically significant difference was obtained in ROM and volumetric measures in any assessment period before and after the block . Satisfaction scores between the groups were also not different in any assessment period . Conclusions Bier block with methylprednisolone and lidocaine in CRPS type I does not provide long-term benefit in CRPS , and its short-term benefit is not superior to placebo Background Efficacy of epidural local anesthetics plus steroids for the treatment of cervicobrachial pain is uncertain . Methods A prospect i ve study r and omized 160 patients with cervicobrachial pain resistant to conventional therapy . Patients were divided into 4 groups on the basis of the time between pain onset and treatment initiation : group A , 40 patients with pain onset 15 to 30 days ; group B , 40 patients with pain from 31 to 60 days ; group C , 40 patients , 61 to 180 days ; and group D , 40 patients with pain > 180 days . Patients of each group were r and omized to receive an epidural block with bupivacaine and methylprednisolone at intervals of 4 to 5 days ( Single injection ) or continuous epidural bupivacaine every 6 , 12 , or 24 hours plus methylprednisolone every 4 to 5 days ( Continuos epidural ) . The maximum duration of treatment ( 9 blocks in Single injection , and 30 days in Continuos epidural ) was dependent on achieving Pain Control ( PC ) ≥80 % [ PC is defined by this formulae : ( 100 ) (VASinitial−VASfinal)/VASinitial ] . Follow-up at 1 month and 6 months compared PC and the number of pain-free hours of sleep . Results One hundred forty-one patients completed the study . The 4 groups had similar characteristics . At the 1-month and 6-month follow-up analysis based on the time between pain onset and treatment initiation showed that patients of group D , who received the Continuous epidural treatment , had significantly greater PC and significantly more pain-free hours of sleep compared with similar patients in Single injection . Conclusions Therapy with continuous epidural local anesthetic and methylprednisolone provides better control of chronic cervicobrachial pain compared with Single injection . These results are discussed with respect to the possible mechanism of action of the drugs and may relate to the physiopathologic mechanisms associated with neuronal plasticity that result in chronic pain Background : Neuropathic pain in spinal cord injury is a common challenging therapeutic condition . The current study examines the analgesic effect of the sodium channel blocker lidocaine on neuropathic pain in patients with spinal cord injury and the predictive role of concomitant evoked pain on pain relief with lidocaine . Methods : Twenty-four spinal cord injury patients with neuropathic pain at or below the level of injury were r and omized and completed a double-blind crossover trial of 5 mg/kg lidocaine and placebo infused over 30 min . Twelve patients reported evoked pain , and 12 patients had no evoked pain . Spontaneous and evoked pains were assessed using a visual analog scale and quantitative sensory testing . Results : Lidocaine significantly reduced spontaneous pain in all patients ( P < 0.01 ) and in each of the two groups with ( P < 0.01 ) and without ( P = 0.048 ) evoked pain , with no difference in number of responders ( pain reduction ≥ 33 % ) between the patients with ( n = 6 ) and without ( n = 5 ) evoked pain . Lidocaine significantly relieved both at-level and below-level neuropathic pain and decreased brush-evoked dysesthesia but not cold allodynia , pinprick hyperalgesia , or pain evoked by repetitive pinprick . Conclusions : Lidocaine reduced neuropathic pain at and below the level of injury irrespective of the presence or absence of evoked pain . Results are consistent with a central -acting effect of sodium channel blockers acting on neuronal hyperexcitability . Agents ( such as anticonvulsants or antiarrhythmics ) with sodium channel – blocking properties may be a treatment option for spinal cord injury pain Study Design . Clinical practice guideline . Objective . To develop evidence -based recommendations on use of interventional diagnostic tests and therapies , surgeries , and interdisciplinary rehabilitation for low back pain of any duration , with or without leg pain . Summary of Background Data . Management of patients with persistent and disabling low back pain remains a clinical challenge . A number of interventional diagnostic tests and therapies and surgery are available and their use is increasing , but in some cases their utility remains uncertain or controversial . Interdisciplinary rehabilitation has also been proposed as a potentially effective noninvasive intervention for persistent and disabling low back pain . Methods . A multidisciplinary panel was convened by the American Pain Society . Its recommendations were based on a systematic review that focused on evidence from r and omized controlled trials . Recommendations were grade d using methods adapted from the US Preventive Services Task Force and the Grading of Recommendations , Assessment , Development , and Evaluation Working Group . Results . Investigators review ed 3348 abstract s. A total of 161 r and omized trials were deemed relevant to the recommendations in this guideline . The panel developed a total of 8 recommendations . Conclusion . Recommendations on use of interventional diagnostic tests and therapies , surgery , and interdisciplinary rehabilitation are presented . Due to important trade-offs between potential benefits , harms , costs , and burdens of alternative therapies , shared decision-making is an important component of a number of the recommendations A total of 57 patients , aged between 23 and 86 years , with complex regional pain syndrome ( CRPS ) type 1 nine weeks after an isolated closed fracture of the distal radius , was r and omised to receive either serial intravenous regional blockade ( IVRB ) with 15 mg of guanethidine in 30 ml of 0.5 % prilocaine or serial IVRB with 30 ml of normal saline at weekly intervals until the tenderness in their fingers had resolved or they had received a maximum of four IVRBs . The analgesic efficacy was assessed at 24 hours , 48 hours and one week after each procedure by the dolorimetry ratio and verbal pain scores , and at intervals up to six months after the fracture . There was no significant difference in the number of IVRBs administered or in finger tenderness , stiffness or grip strength between the two groups . The guanethidine group experienced more pain in the affected h and ( p = 0.025 ) and at six months had more vasomotor instability ( p < 0.0001 ) compared with the control group . IVRB using guanethidine offers no significant analgesic advantage over a normal saline placebo block in the treatment of early CRPS type 1 of the h and after fracture
Output:
| There is sufficient evidence to support recommendations for some of these interventions for selected neuropathic pain conditions . |
MS211841 | ***TASK*** the task is to summarize an input biomedical literature 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: After nearly three decades of studies evaluating the legal practice of involuntary outpatient commitment , there is yet little consensus about its effectiveness and only limited implementation . Debate continues over how best to assist adults with serious mental illnesses who are unable or unwilling to participate in prescribed community treatment and as a result experience repeated involuntary hospitalizations or involvement with the criminal justice system . The authors comment on the Oxford Community Treatment Order Evaluation Trial ( OCTET ) , a recently conducted r and omized trial of outpatient commitment , and discuss the limitations of the study 's design for resolving the persistent question of whether compulsory treatment is more effective than purely voluntary treatment for this difficult-to-reach target population . The authors conclude that the search for a definitive and generalizable r and omized trial of outpatient commitment may be a quixotic quest ; the field should , rather , welcome the results of well-conducted , large-scale , quasi-experimental and naturalistic studies with rigorous multivariable statistical controls The use of coercion to assure that people with a mental illness receive treatment has been the focus one of the longest running controversies among mental health professionals . Until quite recently , however , this debate has been almost entirely based on abstract principles . Empirical research concerning coercion was quite limited . Recently , however , research in this field has blossomed . The development of a vali date d measure of perceived coercion has spawned a variety of new studies . A five-nation study in Sc and inavia has begun the difficult task of assessing the impact of different legal systems and systems of care on perceived coercion . Two new studies have used r and om assignment design s to study the impact of outpatient commitment . This article review s these and other studies and describes what they do , and do not , tell us about coercion in mental health treatment OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate Supervised community treatment to address ' revolving door ' care is part of the new Mental Health Act in Engl and and Wales . Two recent epidemiological studies in Australia ( n>118 000 ) , as well as a systematic review of all previous literature using appropriately matched or r and omised controls ( n=1108 ) , suggest that it is unlikely to help How does society protect some of its most vulnerable and disadvantaged patients while respecting individual autonomy ? This is the dilemma facing many Canadian jurisdictions as they consider the extension of compulsory treatment to community setting s. Canada is not unique but part of a trend to enforce outpatient treatment in many jurisdictions , including Australia , New Zeal and , the United States , and the European Union ( 1,2 ) . What is the basis for this enthusiasm ? Certainly , research published in this journal has endorsed the measure to varying degrees ( 3 ) , as does the position paper of the Canadian Psychiatric Association ( 4 ) . We wonder whether this confidence is misplaced , and we critically examine several troubling aspects of the literature on CTOs . Opinion Is Not Evidence One approach to the evaluation of CTOs has been to ask practising psychiatrists for their opinion on the utility of the orders ( 3 ) . These suggest general support for the measure . However , surveys of psychiatrists ' views on CTOs provide only Level 3 evidence , in contrast to the Level 1 evidence from appropriately conducted RCTs and the Level 2 evidence from well- design ed non- RCT studies , such as case-control studies or interrupted time series . Such surveys have little place in an era of evidence -based practice and , in the absence of other data , would not be accepted as a reason to introduce any other psychiatric intervention . No Controls , Little Evidence Early uncontrolled studies , largely from the United States , suggested that patients on CTOs had reduced rates of rehospitalization and shorter stays in hospital , associated with increased compliance . However , there were no significant differences between the 2 groups when control subjects not subject to a compulsory treatment order were included ( 5 - 7 ) . The weakness of uncontrolled design s is the difficulty in determining the reason for any change in outcome . Aside from the effect of the intervention , other possible explanations include regression to the mean , other treatment , life events , or changes in social circumstances . These often overestimate the effect of the intervention of interest . Controlled studies without r and omization also have shortcomings . There may always be another reason why patients were placed on treatment and the control subjects were not . They may be less insightful about their illness or more likely to have a history of aggressive behaviour . Only one matched control study controlled for forensic history ( 7 ) . What About RCTs ? RCTs address many of these problems but are very difficult to conduct where mental health legislation policy is implemented at a state , provincial , or national level . There have therefore only been 2 RCTs , and both were in the United States ( New York and North Carolina ) ( 8 - 11 ) . These trials have been the subject of much debate in terms of subjects , design , analysis , and generalizability . Selection and Follow-Up Bias : Were the Patients Typical ? Both RCTs excluded patients with a history of violence from r and omization . Although underst and able from an ethical and legal st and point , this limits their applicability because recent dangerousness , particularly violence against others , is often the reason for compulsory treatment in hospital or in the community . One study did include a nonr and omized violent subgroup in the analysis , but this negates the whole point of an RCT ( see below ) ( 9 - 11 ) . Selection bias was further compounded by high dropout rates . Of the 577 patients identified as eligible for participation in the New York and North Carolina studies , including the violent subgroup , only 292 ( 51 % ) were followed up 1 year later . Although the North Carolina study had a higher completion rate among r and omized patients than the New York study ( 82 % and 45 % , respectively ) , data were not available for all patients for all of the outcomes . The 1 -year follow-up is therefore of a highly selected and potentially unrepresentative population that was not dangerous and was sufficiently compliant to participate in baseline and follow-up assessment s. Aims and method Community treatment orders ( CTOs ) were introduced in Scotl and in 2005 , but are controversial owing to a lack of supportive r and omised evidence . The non-r and omised studies provide mixed results on their efficacy and utility . We aim ed to examine hospital bed day usage across Scotl and both before and after CTOs were initiated in a national cohort of patients , spanning 5 years . Results In total , 1558 individuals who were subject to a CTO between 2007 and 2012 , of whom 63 % were male , were included . After CTO initiation the number of hospital bed days fell , on average , from 66 to 39 per annum per patient . Those with a longer psychiatric history appeared to benefit more from a CTO , in terms of reduced time in hospital . Clinical implication s Our data offer cautious support for the use of CTOs in routine practice , in terms of reducing time spent in psychiatric hospital . This finding is balanced by the more rigorous r and omised studies which do not find any benefit to CTOs Background : Supervised Discharge Orders ( SDOs ) were introduced in 1995 , as an amendment to the Mental Health Act in Engl and and Wales . They require patients to abide by specific conditions on discharge from hospital , but can not enforce medication compliance . On introduction , SDOs were received with scepticism by the psychiatric profession . The purpose of this study was to describe the use of SDOs in Engl and and the characteristics of patients made subject to these orders , and to evaluate the effectiveness of the order in securing treatment compliance on discharge from hospital . Method : A survey was conducted of 170 mental health provider Trusts in Engl and . Interviews with senior managers in 12 Trusts and associated Local Authorities were subjected to qualitative analysis , and a cohort of patients subject to SDOs in 56 r and omly sample d Trusts was described . Results : SDOs were being used for 596 patients ( 1.2 per 100,000 total population ) at the survey date in 1999 , and use had been increasing steadily since its introduction . The order is not systematic ally considered for all potential cases . The majority of the 182 patients in the cohort had complied , if sometimes intermittently , with conditions of the order . Conclusions : For patients compliant with SDOs , the pressures necessary to treat effectively need not involve powers to enforce medication compliance This study examines self-reported coercion in subjects with severe mental illness who were r and omly assigned in an experimental study to continue under , or be released from , involuntary outpatient commitment ( OPC ) subsequent to hospital discharge . After review of bivariate relationships , multivariable analyses demonstrated significantly higher levels of reported coercion among subjects who experienced longer periods of OPC ; who were African American ; who were single and not cohabiting ; and who had ongoing substance abuse problems , poor insight into illness , and severe symptoms . Case managers ' verbal reminders to subjects about the consequences of nonadherence to treatment partially account for higher reports of coercion . Previous reports from this study have found that OPC , if sustained and combined with frequent outpatient mental health services , can improve some outcomes . The current analyses demonstrate that a consequence of OPC is increased perceptions of coercion in the treatment process , which is partially explained by the increased attention by case managers to noncompliance with treatment PURPOSE The study evaluated whether seclusion and coercive incidents would be reduced in extent and number if involuntary medication was the first choice of intervention . Patients admitted to an acute psychiatric ward were r and omly allocated to two groups . In Group 1 , involuntary medication was the intervention of first choice for dealing with agitation and risk of violence . In Group 2 , seclusion was the intervention of first choice . Patients ' characteristics between the groups were compared by Pearson χ(2 ) and two- sample t-tests ; the incidence rates and risk ratios ( RRs ) were calculated to examine differences in number and duration of coercive incidents . In Group 1 , the relative risk of being secluded was lower than in Group 2 , whereas the risk of receiving involuntary medication was higher . However , the mean duration of the seclusion incidents did not differ significantly between the two groups ; neither did the total number of coercive incidents . Although the use of involuntary medication could successfully replace and reduce the number of seclusions , alternative interventions are needed to reduce the overall number and duration of coercive incidents . A new policy for managing acute aggression - such as involuntary medication - can be implemented effectively only if certain conditions are met The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas OBJECTIVE The authors ' goal was to evaluate the effectiveness of outpatient commitment in reducing victimization among people with severe mental illness . METHOD One hundred eighty-four involuntarily hospitalized patients were r and omly assigned to be released ( N=99 ) or to continue under outpatient commitment ( N=85 ) after hospital discharge . An additional group of patients with a recent history of serious violent behavior ( N=39 ) was nonr and omly assigned to at least a brief period of outpatient commitment following hospital disharge . All three groups were followed for 1 year , and case management services plus additional outpatient treatment were provided to all subjects . Outcome data were based on interviews with the patients and informants as well as service records
Output:
| CCT results in no significant difference in service use , social functioning or quality of life compared with st and ard voluntary care .
People receiving CCT were , however , less likely to be victims of violent or non-violent crime .
It is unclear whether this benefit is due to the intensity of treatment or its compulsory nature .
Short periods of conditional leave may be as effective ( or non-effective ) as formal compulsory treatment in the community . |
MS211842 | ***TASK*** the task is to summarize an input biomedical literature 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: Based on research demonstrating associations between folate , B-12 and B-6 vitamins and cognition and mood , we investigated the effects of short-term supplementation in 211 healthy younger , middle-aged and older women who took either 750 microg of folate , 15 microg of vitamin B-12 , 75 mg of vitamin B-6 or a placebo daily for 35 d. In addition , we examined associations between dietary intake of these vitamins and cognition and mood . Usual dietary intake status was estimated using a retrospective , self-report , quantified food frequency question naire . Participants completed alternate forms of st and ardized tests of cognitive processing re sources , memory , executive function , verbal ability and self-report mood measures before and after supplementation . Supplementation had a significant positive effect on some measures of memory performance only , and no effect on mood . Dietary intake status was associated with speed of processing , recall and recognition and verbal ability BACKGROUND Frail elders are at risk of suboptimal micronutrient status , functional decline , and neurologic disorders . The influence of oral multimicronutrients in physiologic doses and of moderately intense physical exercise on homocysteine ( Hcy ) , methylmalonic acid ( MMA ) , and neurologic functioning have not yet been investigated . OBJECTIVE Our goal was to determine the effects of enriched foods and exercise on blood vitamins , Hcy , MMA , and neuropsychological functioning in the frail . DESIGN A 17-wk r and omized controlled intervention trial was used to study 1 ) enriched foods plus a social program , 2 ) regular foods plus exercise , 3 ) enriched foods plus exercise , and 4 ) regular foods plus a social program . Enriched foods contained multiple micronutrients ( 25 - 100 % of the Dutch recommended dietary allowances ) ; exercises focused on strength , coordination , flexibility , and endurance . Vitamin ( cobalamin , red blood cell folate , and pyridoxal 5'-phosphate ) , Hcy , and MMA concentrations were measured and 2 neuropsychological tests were conducted . RESULTS Vitamin concentrations were higher in the supplemented groups than in the unsupplemented groups ( P < 0.001 ; total n = 130 ) . Compared with baseline , cobalamin in the supplemented groups was increased by 22 % , plasma folate by 101 % , red blood cell folate by 87 % , and pyridoxal 5'-phosphate by 68 % . Concentrations in the unsupplemented groups changed by -2 % , -6 % , 1 % , and -13 % , respectively . Hcy decreased by 25 % and MMA by 30 % in the supplemented groups , compared with a small increase in Hcy ( 2 % ) and decrease in MMA ( 9 % ) in the unsupplemented groups . Exercise did not significantly affect vitamin , Hcy , or MMA concentrations . No significant effect of either intervention was observed on the neuropsychological tests . CONCLUSIONS The decrease in Hcy and MMA in frail elders confirms a sub clinical metabolic deficiency state . Enriched foods containing physiologic amounts of micronutrients have a beneficial effect on these metabolites . No effects of B vitamins on mental health were identified Paulinia cupana ( guarana ) is a Brazilian plant given great prestige in popular medicine , for example as being a potent stimulator of brain functions . The authors assessed the effects of the long-term administration of guarana on the cognition of normal , elderly volunteers . Forty-five volunteers were studied , with a r and om distribution in three experimental groups : placebo ( n = 15 ) , caffeine ( n = 15 ) , and guarana ( n = 15 ) , in a double-blind study . There were no significant cognitive alterations in these volunteers Objective : To determine the efficacy of acetyl-l-carnitine ( ALCAR ) on the rate of decline in early-onset AD patients . Methods : A 1-year , multicenter , double-blind , placebo-controlled , r and omized trial was conducted . Subjects were 45 to 65 years old , with a diagnosis of probable AD according to National Institute of Neurological Communicative Disorders – Alzheimer ’s Disease and Related Disorders Association criteria and had a Mini-Mental State Examination ( MMSE ) score between 12 and 26 . They were treated with ALCAR ( 1 g tid ) or placebo . Primary outcome measures were the Alzheimer ’s Disease Assessment Scale – Cognitive Component and the Clinical Dementia Rating Scale . Secondary measures included the ADAS Non-Cognitive Subscale , the MMSE , an Activities of Daily Living Scale ( ADL ) , and a Clinician-Based Impression of Change ( CIBIC ) . Results : Two-hundred twenty-nine patients were enrolled and r and omized to drug treatment , with 117 taking placebo and 112 taking ALCAR . There were no significant differences between the two groups at baseline . For the primary outcome measures , there were no significant differences between the treatment groups on the change from baseline to endpoint in the intent-to-treat analysis . In the completer sample only , there was less deterioration in the MMSE for the ALCAR-treated subjects . There was no difference in rate of decline on the CIBIC and the ADL scale . There were no significant differences in the incidence of adverse events by treatment arm . Conclusion : Overall , in a prospect ively performed study in young-onset AD patients , ALCAR failed to slow decline . Less decline was seen on the MMSE in the completer sample only , with the difference being mediated by reducing decline in attention . A combination of ALCAR and a cholinesterase inhibitor should be tested for additivity OBJECTIVES To assess the longitudinal effects of acety-L-carnitine ( ALC ) on patients diagnosed with Alzheimer 's disease . DESIGN Longitudinal , double-blind , parallel-group , placebo-controlled . SETTING Twenty-four outpatient sites across the United States . PARTICIPANTS A total of 334 subjects diagnosed with probable Alzheimer 's disease by NINCDS-ADRDA criteria . These data were originally reported by Thal and colleagues ( 1996 ) . MEASUREMENTS Cognitive subscale of the Alzheimer Disease Assessment Scale ( ADAS ) given every 3 months for 1 year . RESULTS The average rate of change was estimated using the trilinear approach , which allows for periods of both change and stability . Both the ALC group and the placebo group exhibited the same mean rate of change on the ADAS ( 0.68 points/month ) . However , a multiple regression analysis revealed a statistically significant Age x Drug interaction characterized by younger subjects benefiting more from ALC , significant , cutpoint for ALC benefit was 61 years of age . CONCLUSIONS ALC slows the progression of Alzheimer 's disease in younger subjects , and the use of the trilinear approach to estimate the average rate of change may prove valuable in pharmacological trials BACKGROUND There is evidence that medications or vitamins that increase the levels of brain catecholamines and protect against oxidative damage may reduce the neuronal damage and slow the progression of Alzheimer 's disease . METHODS We conducted a double-blind , placebo-controlled , r and omized , multicenter trial in patients with Alzheimer 's disease of moderate severity . A total of 341 patients received the selective monoamine oxidase inhibitor selegiline ( 10 mg a day ) , alpha-tocopherol ( vitamin E , 2000 IU a day ) , both selegiline and alpha-tocopherol , or placebo for two years . The primary outcome was the time to the occurrence of any of the following : death , institutionalization , loss of the ability to perform basic activities of daily living , or severe dementia ( defined as a Clinical Dementia Rating of 3 ) . RESULTS Despite r and om assignment , the baseline score on the Mini-Mental State Examination was higher in the placebo group than in the other three groups , and this variable was highly predictive of the primary outcome ( P<0.001 ) . In the unadjusted analyses , there was no statistically significant difference in the outcomes among the four groups . In analyses that included the base-line score on the Mini-Mental State Examination as a covariate , there were significant delays in the time to the primary outcome for the patients treated with selegiline ( median time , 655 days ; P=0.012 ) , alpha-tocopherol ( 670 days , P=0.001 ) or combination therapy ( 585 days , P=0.049 ) , as compared with the placebo group ( 440 days ) . CONCLUSIONS In patients with moderately severe impairment from Alzheimer 's disease , treatment with selegiline or alpha-tocopherol slows the progression of disease A r and omized , double-blind , placebo-controlled , parallel-group clinical trial was carried out to compare 24-week periods of treatment with 1 g acetyl-l-carnitine twice daily and placebo in the treatment of patients with dementia of the Alzheimer type . A total of 36 patients entered the trial , of whom 20 patients ( 7 active , 13 placebo ) completed the full 24 weeks . Whilst several of the efficacy indices showed little change in either group during the trial , there was an apparent trend for more improvement in the acetyl-l-carnitine group in relation to the Names Learning Test and a computerized Digit Recall Test , both related to aspects of short-term memory . Similarly , there was a trend for reaction time in the computerized classification test to show less deterioration in the active treatment group . Changes within groups , and changes between groups , failed to reach statistical significance , at least partially because of the small number of patients available for analysis . Two indices of overall therapeutic benefit showed a trend for less deterioration in the active-treatment group than in the placebo group . Nausea and /or vomiting occurred in 5 patients in the acetyl-l-carnitine group . Laboratory tests revealed no signs of drug toxicity . The results suggest that acetyl-l-carnitine may have a beneficial effect on some clinical features of Alzheimer-type dementia , particularly those related to short-term memory 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 In two double-blind , placebo-controlled clinical studies of the nootropic compound acetyl-L-carnitine on the electroencephalogram ( EEG ) and impaired brain functions of elderly out patients with mild to moderate cognitive decline of the organic brain syndrome , statistically significant effects could be detected after eight weeks ( on the EEG ) , and after 12 weeks of treatment ( on the physician 's clinical global impression and the patient-rated level of activities of daily living ) . Side-effects of acetyl-L-carnitine were generally minor and overall rare . Longer treatment periods and further specifications with regard to the aetiopathology and degree of cognitive impairment are recommended for further clinical studies of this promising compound Acetyl levocarnitine hydrochloride has been reported to retard dementia in patients with Alzheimer 's disease . In a double-blind , parallel design , placebo-controlled pilot study of 30 mild to moderately demented patients with probable Alzheimer 's disease , tests of memory , attention , language , visuospatial , and constructional abilities were administered , and the level of acetyl levocarnitine was measured in the cerebrospinal fluid . Patients were then r and omly assigned to receive acetyl levocarnitine hydrochloride ( 2.5 g/d for 3 months followed by 3 g/d for 3 months ) or placebo . After 6 months , the acetyl levocarnitine group demonstrated significantly less deterioration in timed cancellation tasks and Digit Span ( forward ) and a trend toward less deterioration in a timed verbal fluency task . No differences were found in any other neuropsychological test results . A subgroup with the lowest baseline scores , receiving acetyl levocarnitine , had significantly less deterioration on the verbal memory test and a significant increase in cerebrospinal fluid acetyl levocarnitine levels compared with those receiving placebo . These results suggest that acetyl levocarnitine may retard the deterioration in some cognitive areas in patients with Alzheimer 's disease and stress the need for a larger study of this drug This study evaluates the effects of vitamin B-6 supplementation ( 20 mg pyridoxine HCL daily for 3 months ) on mood and performance in 38 self-supporting healthy men , aged between 70–79 years . Effects were compared with 38 controls who received placebo and were matched for age , plasma pyridoxal-5′-phosphate ( PLP ) concentration
Output:
| Despite the heterogeneity in trial design , the results of this review suggest that nutritional supplements may improve the cognitive functioning of elderly persons and do no harm . |
MS211843 | ***TASK*** the task is to summarize an input biomedical literature 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 A number of breast cancer risk prediction models have been developed to provide insight into a woman 's individual breast cancer risk . Although circulating levels of estradiol in postmenopausal women predict subsequent breast cancer risk , whether the addition of estradiol levels adds significantly to a model 's predictive power has not previously been evaluated . Methods Using linear regression , the authors developed an imputed estradiol score using measured estradiol levels ( the outcome ) and both case status and risk factor data ( for example , body mass index ) from a nested case-control study conducted within a large prospect i ve cohort study and used multiple imputation methods to develop an overall risk model including both risk factor data from the main cohort and estradiol levels from the nested case-control study . Results The authors evaluated the addition of imputed estradiol level to the previously published Rosner and Colditz log-incidence model for breast cancer risk prediction within the larger Nurses ' Health Study cohort . The follow-up was from 1980 to 2000 ; during this time , 1,559 invasive estrogen receptor-positive breast cancer cases were confirmed . The addition of imputed estradiol levels significantly improved risk prediction ; the age-specific concordance statistic increased from 0.635 ± 0.007 to 0.645 ± 0.007 ( P < 0.001 ) after the addition of imputed estradiol . Conclusion Circulating estradiol levels in postmenopausal women appear to add to other lifestyle factors in predicting a woman 's individual risk of breast cancer Key Summary Points Risk prediction models are statistical models used to predict the probability of an outcome on the basis of the values of 1 or more risk factors ( markers ) . The accuracy of the model 's predictions is typically summarized with statistics that describe the model 's discrimination and calibration . Risk stratification tables are a more informative way to assess and compare the models . The tables illustrate the distribution of predictions across risk categories . That illustration allows users to assess 3 key measures of the models ' value for guiding medical decisions : the models ' calibration , ability to stratify people into clinical ly relevant risk categories , and accuracy at classifying patients into higher- and lower-risk categories . This information is contained in the margins of the risk stratification table rather than in its cells . The tables should only be used to compare risk prediction models when one of the models contains all of the markers that are contained in the other ( nested models ) ; they should not be used to compare models with different sets of markers ( nonnested models ) . The table predictions require corrections when casecontrol data are used . The recent epidemiologic and clinical literature is filled with studies evaluating statistical models that predict risk for disease or some other adverse event ( 15 ) . Because risk prediction models are intended to help patients and clinicians make decisions , evaluation of these models requires methods that differ from those used to assess models describing disease etiology . This is because the characteristics of the models are less important than their value for guiding decisions . Cook and colleagues ( 1 , 6 ) recently proposed a new approach to evaluate risk prediction models : a risk stratification table . This methodology appropriately focuses on the key purpose of a risk prediction model , which is to classify individuals into clinical ly relevant risk categories , and it has therefore been widely adopted in the literature ( 24 ) . We examine the risk stratification approach in detail in this article , identifying the relevant information that can be abstract ed from a risk stratification table and caution ing against misuses of the method that frequently occur in practice . We use a recently published study of a breast cancer risk prediction model by Tice and colleagues ( 2 ) to illustrate the concepts . Background A risk prediction marker is any measure that is used to predict a person 's risk for an event . It may be a quantitative measure , such as high-density lipoprotein cholesterol level , or a qualitative measure , such as family history of disease . Risk predictors are also risk factors , in the sense that they will necessarily be strongly associated with the risk for disease . But a large , significant association does not assure that the marker has value in predicting risk for many people . A risk prediction model is a statistical model that combines information from several markers . Common types include logistic regression models , Cox proportional hazard models , and classification trees . Each type of model produces a predicted risk for each person by using information in the model . Consider , for example , a model predicting breast cancer risk that includes age as the only predictor . The result ing risk prediction for a woman of a given age is simply the proportion of women her age who develop breast cancer . The woman 's predicted risk will change if more information is included in the model . For instance , if family history information is added , her predicted risk will be the proportion of women her age and with her family history who develop breast cancer . The purpose of a risk prediction model is to accurately stratify individuals into clinical ly relevant risk categories . This risk information can be used to guide clinical or policy decisions , for example , about preventive interventions for persons or disease screening for sub population s identified as high risk , or to select persons for inclusion in clinical trials . The value of a risk prediction model for guiding these kinds of decisions can be judged by the extent to which the risk calculated from the model reflects the fraction of persons in the population with actual events ( its calibration ) ; the proportions in which the population is stratified into clinical ly relevant risk categories ( its stratification capacity ) ; and the extent to which participants with events are assigned to high-risk categories and those without events are assigned to low-risk categories ( its classification accuracy ) . Risk prediction models are commonly evaluated by using the receiver-operating characteristic ( ROC ) curve ( 4 , 7 ) , which is a st and ard tool for evaluating the discriminatory accuracy of diagnostic or screening markers . This curve shows the true-positive rate plotted against the false-positive rate for rules that classify persons by using risk thresholds that vary over allpossible values . Receiver-operating characteristic curves are generally not helpful for evaluating risk prediction models because they do not provide information about the actual risks that the models predict or about the proportion of participants who have high or low risk values . Moreover , when comparing ROC curves for 2 risk prediction models , the models are aligned according to their false-positive rates ( that is , different risk thresholds are applied to the 2 models to achieve the same false-positive rate ) . This is clearly inappropriate . In addition , the area under the ROC curve or c-statistic , a commonly reported summary measure that can be interpreted as the probability that the predicted risk for a participant with an event is higher than that for a participant without an event , has little direct clinical relevance . Clinicians are never asked to compare risks for a pair of patients one who will eventually have the event and one who will not . Neither the ROC curve nor the c-statistic relates to the practical task of predicting risks for clinical decision making . Cook and colleagues ( 1 , 6 ) propose using risk stratification tables to evaluate the incremental value of a new marker , or the benefit of adding a new marker ( for example , C-reactive protein ) , to an established set of risk predictors ( for example , Framingham risk predictors , such as age , diabetes , cholesterol level , smoking , and low-density lipoprotein cholesterol levels ) . In these stratification tables , risks calculated from models with and without the new marker are cross-tabulated . This approach represents a substantial improvement over the use of ROC methodology because it displays the risks calculated by use of the model and the proportions of individuals in the population who are stratified into the risk groups . We will provide an example of this approach and show how information about model calibration , stratification capacity , and classification accuracy can be derived from a risk stratification table and used to assess the added value of a marker for clinical and health care policy decisions . Example Tice and colleagues ( 2 ) published a study that builds and evaluates a model for predicting breast cancer risk by using data from 1095484 women in a prospect i ve cohort and incidence data from the Surveillance , Epidemiology , and End Results data base . Age , race or ethnicity , family history , and history of breast biopsy were used to model risk with a Cox proportional hazard model . The study focused on the benefit of adding breast density information to the model . The hazard ratio for breast density in the multivariate model ( extremely dense vs. almost entirely fat ) was estimated as 4.2 for women younger than age 65 years and 2.2 for women age 65 years or older . This suggests that breast density is strongly associated with disease riskthat is , that breast cancer rates are higher among women with higher breast density . However , it does not describe the value of breast density for helping women make informed clinical decisions , which requires knowledge of the frequency distribution of breast density in the population . To evaluate the added value of breast density , Tice and colleagues defined 5-year breast cancer risk categories as low ( # # lt##1 % ) , low to intermediate ( 1 % to 1.66 % ) , intermediate to high ( 1.67 % to 2.5 % ) , and high ( # # gt##2.5 % ) . The 1.67 % cutoff for intermediate risk was presumably chosen on the basis of recommendations by the American Society of Clinical Oncology ( 8) and the Canadian Task Force on Preventive Health Care ( 9 ) to counsel women with 5-year risks greater than this threshold about considering tamoxifen for breast cancer prevention . Tice and colleagues used a risk stratification table ( Table 1 ) to compare risk prediction models with and without breast density . Table 1 . Five-Year Risks for Breast Cancer as Predicted by Models That Do and Do Not Include Breast Density Calibration Assessing model calibration is an important first step in evaluating any risk prediction model . Good calibration is essential ; it means that the model-predicted probability of an event for a person with specified predictor values is the same as or very close to the proportion of all persons in the population with those same predictor values who experience the event ( 10 ) . With many predictors , and especially with continuous predictors , we can not evaluate calibration at each possible predictor value because there are too few participants with exactly those values . Instead , the st and ard approach is to place persons within categories of predicted risk and to compare the category values with the observed event rates for participants in each category . The calibration of the risk prediction models for breast cancer can be assessed by comparing the proportions of events in the margins of Table 1 with the corresponding row and column labels . For the model without breast density , the proportions of observed events within each risk category are in the far-right Total column and they generally agree Objectives To develop a predictive model for pre-eclampsia based on clinical risk factors for nulliparous women and to identify a subgroup at increased risk , in whom specialist referral might be indicated . Design Prospect i ve multicentre cohort . Setting Five centres in Auckl and , New Zeal and ; Adelaide , Australia ; Manchester and London , United Kingdom ; and Cork , Republic of Irel and . Participants 3572 “ healthy ” nulliparous women with a singleton pregnancy from a large international study ; data on pregnancy outcome were available for 3529 ( 99 % ) . Main outcome measure Pre-eclampsia defined as ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg , or both , on at least two occasions four hours apart after 20 weeks ’ gestation but before the onset of labour , or postpartum , with either proteinuria or any multisystem complication . Preterm pre-eclampsia was defined as women with pre-eclampsia delivered before 37 + 0 weeks ’ gestation . In the stepwise logistic regression the comparison group was women without pre-eclampsia . Results Of the 3529 women , 186 ( 5.3 % ) developed pre-eclampsia , including 47 ( 1.3 % ) with preterm pre-eclampsia . Clinical risk factors at 14 - 16 weeks ’ gestation were age , mean arterial blood pressure , body mass index ( BMI ) , family history of pre-eclampsia , family history of coronary heart disease , maternal birth weight , and vaginal bleeding for at least five days . Factors associated with reduced risk were a previous single miscarriage with the same partner , taking at least 12 months to conceive , high intake of fruit , cigarette smoking , and alcohol use in the first trimester . The area under the receiver operating characteristics curve ( AUC ) , under internal validation , was 0.71 . Addition of uterine artery Doppler indices did not improve performance ( internal validation AUC 0.71 ) . A framework for specialist referral was developed based on a probability of pre-eclampsia generated by the model of at least 15 % or an abnormal uterine artery Doppler waveform in a subset of women with single risk factors . Nine per cent of nulliparous women would be referred for a specialist opinion , of whom 21 % would develop pre-eclampsia . The relative risk for developing pre-eclampsia and preterm pre-eclampsia in women referred to a specialist compared with st and ard care was 5.5 and 12.2 , respectively . Conclusions The ability to predict pre-eclampsia in healthy nulliparous women using clinical phenotype is modest and requires external validation in other population s. If vali date d , it could provide a personalised clinical risk profile for nulliparous women to which biomarkers could be added . Trial registration ACTRN12607000551493 The analytical effect of the number of events per variable ( EPV ) in a proportional hazards regression analysis was evaluated using Monte Carlo simulation techniques for data from a r and omized trial containing 673 patients and 252 deaths , in which seven predictor variables had an original significance level of p < 0.10 . The 252 deaths and 7 variables correspond to 36 events per variable analyzed in the full data set . Five hundred simulated analyses were conducted for these seven variables at EPVs of 2 , 5 , 10 , 15 , 20 , and 25 . For each simulation , a r and om exponential survival time was generated for each of the 673 patients , and the simulated results were compared with their original counterparts . As EPV decreased , the regression coefficients became more biased relative to the true value ; the 90 % confidence limits about the simulated values did not have a coverage of 90 % for the original value ; large sample properties did not hold for variance estimates from the proportional hazards model , and the Z statistics used to test the significance of the regression coefficients lost validity under the null hypothesis . Although a single boundary level for avoiding problems is not easy to choose , the value of EPV =
Output:
| Most models yielded relatively poor discrimination in both internal and external validation .
This poor discriminatory accuracy of existing models might be because of a lack of knowledge about risk factors , heterogeneous subtypes of breast cancer , and different distributions of risk factors across population s. In addition the concordance statistic itself is insensitive to measure the improvement of discrimination . |
MS211844 | ***TASK*** the task is to summarize an input biomedical literature 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 appropriate dietary intervention for overweight persons with type 2 diabetes mellitus ( DM2 ) is unclear . Trials comparing the effectiveness of diets are frequently limited by short follow-up times and high dropout rates . AIM The effects of a low carbohydrate Mediterranean ( LCM ) , a traditional Mediterranean ( TM ) , and the 2003 American Diabetic Association ( ADA ) diet were compared , on health parameters during a 12-month period . METHODS In this 12-month trial , 259 overweight diabetic patients ( mean age 55 years , mean body mass index 31.4 kg/m(2 ) ) were r and omly assigned to one of the three diets . The primary end-points were reduction of fasting plasma glucose , HbA1c and triglyceride ( TG ) levels . RESULTS 194 patients out of 259 ( 74.9 % ) completed follow-up . After 12 months , the mean weight loss for all patients was 8.3 kg : 7.7 kg for ADA , 7.4 kg for TM and 10.1 kg for LCM diets . The reduction in HbA1c was significantly greater in the LCM diet than in the ADA diet ( -2.0 and -1.6 % , respectively , p < 0.022 ) . HDL cholesterol increased ( 0.1 mmol/l + /- 0.02 ) only on the LCM ( p < 0.002 ) . The reduction in serum TG was greater in the LCM ( -1.3 mmol/l ) and TM ( -1.5 mmol/l ) than in the ADA ( -0.7 mmol/l ) , p = 0.001 . CONCLUSIONS An intensive 12-month dietary intervention in a community-based setting was effective in improving most modifiable cardiovascular risk factors in all the dietary groups . Only the LCM improved HDL levels and was superior to both the ADA and TM in improving glycaemic control Mediterranean-inspired diets have been shown to decrease cholesterol levels in patients with hypercholesterolaemia , who frequently exhibit endothelial dysfunction . The aims of the present study are to improve endothelial function by dietary intervention in healthy subjects with lipid levels representative of a Western population . Twenty-two healthy subjects ( mean total cholesterol , 5.6 mmol/l ) were given a Mediterranean-inspired diet rich in omega-3 fatty acids and sterol esters , but low in saturated fat , or an ordinary Swedish diet , for 4 weeks in a r and omized cross-over study . The composition of the diets were : in the Swedish diet , 2090 kcal ( where 1 kcal=4.184 kJ ; 48 % of energy from carbohydrate , 15 % from protein and 36 % from fat ) and 19 g of fibre ; in the Mediterranean-inspired diet , 1869 kcal ( 48 % of energy from carbohydrate , 16 % from protein , 34 % from fat ) and 40 g of fibre . After each dietary period , fasting blood lipids , insulin and glucose levels , as well as apo B ( apolipoprotein B ) and LDL ( low-density lipoprotein ) particle size , were analysed . Endothelial-dependent and -independent vasodilation was measured invasively by venous occlusion plethysmography , and arterial distensibility was assessed by echocardiography tracking . Fibrinolytic capacity across the forearm , as well as oxidative stress measured through urinary F(2)-isoprostane , were evaluated . Total , LDL- and apo B-cholesterol and triacylglycerol ( triglyceride ) concentrations were decreased by 17 % , 22 % , 16 % and 17 % respectively , after the Mediterranean-inspired diet compared with the Swedish diet ( P < 0.05 for all ) . However , no differences in plasma concentrations of insulin and glucose and LDL particle size , endothelial function , arterial distensibility , fibrinolytic capacity or oxidative stress were detected . Treatment for 4 weeks with a Mediterranean-inspired diet decreased blood lipids in healthy individuals with a low-risk profile for cardiovascular disease . This beneficial effect was not mirrored in vascular function or oxidative stress evaluation BACKGROUND Adherence to a Mediterranean diet may improve longevity , but relevant data are limited . METHODS We conducted a population -based , prospect i ve investigation involving 22,043 adults in Greece who completed an extensive , vali date d , food-frequency question naire at base line . Adherence to the traditional Mediterranean diet was assessed by a 10-point Mediterranean-diet scale that incorporated the salient characteristics of this diet ( range of scores , 0 to 9 , with higher scores indicating greater adherence ) . We used proportional-hazards regression to assess the relation between adherence to the Mediterranean diet and total mortality , as well as mortality due to coronary heart disease and mortality due to cancer , with adjustment for age , sex , body-mass index , physical-activity level , and other potential confounders . RESULTS During a median of 44 months of follow-up , there were 275 deaths . A higher degree of adherence to the Mediterranean diet was associated with a reduction in total mortality ( adjusted hazard ratio for death associated with a two-point increment in the Mediterranean-diet score , 0.75 [ 95 percent confidence interval , 0.64 to 0.87 ] ) . An inverse association with greater adherence to this diet was evident for both death due to coronary heart disease ( adjusted hazard ratio , 0.67 [ 95 percent confidence interval , 0.47 to 0.94 ] ) and death due to cancer ( adjusted hazard ratio , 0.76 [ 95 percent confidence interval , 0.59 to 0.98 ] ) . Associations between individual food groups contributing to the Mediterranean-diet score and total mortality were generally not significant . CONCLUSIONS Greater adherence to the traditional Mediterranean diet is associated with a significant reduction in total mortality BACKGROUND Diet has been reported to influence arterial blood pressure , and evidence indicates that the Mediterranean diet reduces cardiovascular mortality . OBJECTIVE The objective was to examine whether the Mediterranean diet , as an entity , and olive oil , in particular , reduce arterial blood pressure . DESIGN Arterial blood pressure and several sociodemographic , anthropometric , dietary , physical activity , and clinical variables were recorded at enrollment among participants in the Greek arm of the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) study . Of these participants , 20 343 had never received a diagnosis of hypertension and were included in an analysis in which systolic and diastolic blood pressure were regressed on the indicated possible predictors , including a 10-point score that reflects adherence to the Mediterranean diet and , alternatively , the score 's individual components and olive oil . RESULTS The Mediterranean diet score was significantly inversely associated with both systolic and diastolic blood pressure . Intakes of olive oil , vegetables , and fruit were significantly inversely associated with both systolic and diastolic blood pressure , whereas cereals , meat and meat products , and ethanol intake were positively associated with arterial blood pressure . Mutual adjustment between olive oil and vegetables , which are frequently consumed together , indicated that olive oil has the dominant beneficial effect on arterial blood pressure in this population . CONCLUSIONS Adherence to the Mediterranean diet is inversely associated with arterial blood pressure , even though a beneficial component of the Mediterranean diet score-cereal intake-is positively associated with arterial blood pressure . Olive oil intake , per se , is inversely associated with both systolic and diastolic blood pressure BACKGROUND Greater adherence to the Mediterranean diet has been associated with a lower incidence of cardiovascular disease and cancer . OBJECTIVE We studied the effect of the Mediterranean diet on total antioxidant capacity ( TAC ) in 3042 participants who had no clinical evidence of cardiovascular disease . DESIGN During 2001 - 2002 , a r and om sample of 1514 men and 1528 women aged 18 - 89 y from the Attica area of Greece was selected . TAC was measured with an immune-diagnostic assay . Food consumption was evaluated with a vali date d food-frequency question naire , and adherence to the Mediterranean diet was assessed on the basis of a diet score that incorporated the inherent characteristics of this diet . RESULTS TAC was positively correlated with diet score . The participants in the highest tertile of the diet score had , on average , 11 % higher TAC levels than did the participants in the lowest tertile , even after adjustment for relevant confounders ( P < 0.01 ) . On the other h and , the participants in the highest tertile of the diet score had , on average , 19 % lower oxidized LDL-cholesterol concentrations than did the participants in the lowest tertile ( P < 0.01 ) . An additional analysis showed that TAC was positively correlated with the consumption of olive oil ( rho = 0.54 , P = 0.002 ) and of fruit and vegetables ( rho = 0.34 and rho = 0.31 , respectively ; P < 0.001 for both ) , whereas it was inversely associated with the consumption of red meat ( rho = -0.35 , P = 0.02 ) . CONCLUSION Greater adherence to the Mediterranean diet is associated with elevated TAC levels and low oxidized LDL-cholesterol concentrations , which may explain the beneficial role of this diet on the cardiovascular system BACKGROUND Although the typical diet of the Mediterranean region has received much recognition over the past several years for its association with substantial health benefits , it remains unknown whether its favorable effects are mediated through changes in adiponectin concentrations . OBJECTIVE The objective was to determine whether adherence to a Mediterranean-type diet is associated with higher plasma adiponectin concentrations . DESIGN This study was a prospect i ve and cross-sectional evaluation of plasma adiponectin concentrations and dietary data from 987 diabetic women from the Nurses ' Health Study who had no history of cardiovascular disease at the time blood was drawn in 1990 . RESULTS Women who scored highest on a 9-point scale that measures adherence to a Mediterranean-type dietary pattern tended to be older , were less likely to be current smokers , had lower body mass indexes and waist circumferences , and had higher total energy intakes , physical activities , and plasma adiponectin concentrations than did women with the lowest scores . Median plasma adiponectin concentrations were 23 % higher in women who most closely followed a Mediterranean-type diet than in low adherers after adjustment for age and energy intake ( P < 0.01 ) . Body composition , lifestyle , and medical history explained some , but not all , of the observed association between diet and adiponectin concentrations because high adherers tended to have greater adiponectin concentrations than did moderate or low adherers , even after adjustment for these variables . CONCLUSIONS Our data suggest that , of the several components of the Mediterranean dietary pattern score , alcohol , nuts , and whole grains show the strongest association with adiponectin concentrations . Close adherence to a Mediterranean-type diet is associated with higher adiponectin concentrations BACKGROUND An important therapeutic goal for patients with type 2 diabetes is weight loss , which improves metabolic abnormalities . Ad libitum low-fat diets cause weight loss in nondiabetic population s. Compared with diets higher in monounsaturated fat , however , eucaloric low-fat diets may increase plasma triacylglycerol concentrations and worsen glycemic control in persons with type 2 diabetes . OBJECTIVE We investigated whether , in type 2 diabetes patients , an ad libitum low-fat diet would cause greater weight loss than would a high-monounsaturated fat diet and would do this without increasing plasma triacylglycerol concentrations or worsening glycemic control . DESIGN Eleven patients with type 2 diabetes were r and omly assigned to receive an ad libitum low-fat , high-carbohydrate diet or a high-monounsaturated fat diet , each for 6 wk . The diets offered contained 125 % of the estimated energy requirement to allow self- selection of food quantity . The response variables were body weight ; fasting plasma lipid , lipoprotein , glucose , glycated hemoglobin A(1c ) , and fructosamine concentrations ; insulin sensitivity ; and glucose disposal . RESULTS Body weight decreased significantly ( 1.53 kg ; P < 0.001 ) only with the low-fat diet . Plasma total , LDL- , and HDL-cholesterol concentrations tended to decrease during both diets . There were no interaction effects between diet and the lipid profile response over time . Plasma triacylglycerol concentrations , glycemic control , and insulin sensitivity did not differ significantly between the 2 diets . CONCLUSION Contrary to expectations , the ad libitum , low-fat , high-fiber diet promoted weight loss in patients with type 2 diabetes without causing unfavorable alterations in plasma lipids or glycemic control A r and omised crossover study of eight overweight or obese
Output:
| These results are of considerable public health importance , because this dietary pattern can be easily adopted by all population groups and various cultures and cost-effectively serve for primary and secondary prevention of the MS and its individual components |
MS211845 | ***TASK*** the task is to summarize an input biomedical literature 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 evaluate the influence of renal function on the efficacy and safety of the sodium glucose cotransporter 2 inhibitor luseogliflozin ( TS-071 ) in Japanese patients with type 2 diabetes mellitus ( T2DM ) . METHODS Study 1 was a 52-week , Phase III study to evaluate the efficacy and safety of 2.5 mg/d luseogliflozin ( or increased to 5 mg/d ) in patients with T2DM with moderate renal impairment . During the initial 24 weeks , efficacy and safety of luseogliflozin were compared with placebo . Study 2 was a pooled analysis of four 52-week , Phase III studies of luseogliflozin , including Study 1 , to evaluate the efficacy and safety of luseogliflozin in patients with various degrees of renal function . Patients were stratified into 3 groups by baseline estimated glomerular filtration rate ( eGFR ) : normal renal function ( ≥90 mL/min/1.73 m(2 ) ) , mild impairment ( ≥60 to < 90 mL/min/1.73 m(2 ) ) , and moderate impairment ( ≥30 to < 60 mL/min/1.73 m(2 ) ) . Patients with moderate impairment were further divided into those with mild-moderate ( ≥45 to < 60 mL/min/1.73 m(2 ) ) and moderate-severe ( ≥30 to < 45 mL/min/1.73 m(2 ) ) . In both studies , efficacy end points included changes in glycated hemoglobin ( HbA1c ) level , fasting plasma glucose ( FPG ) level , and body weight . The safety end points included adverse events ( AEs ) and laboratory parameters . FINDINGS In Study 1 , HbA1c , FPG , and body weight significantly decreased at Week 24 in patients treated with luseogliflozin compared with patients treated with placebo , with the decrease in these parameters also observed with luseogliflozin at Week 52 . The incidence of AEs was similar between groups . In Study 2 , 1030 patients were included ( normal , 275 ; mildly impaired , 598 ; and moderately impaired , 157 ) . At Week 52 , HbA1c , FPG , and body weight were significantly decreased from baseline in all groups . In between-group comparisons , the decreases in HbA1c and body weight were significantly smaller in patients with moderate impairment than in those with normal function ; however , the HbA1c-lowering efficacy was reduced by nearly half , whereas the efficacy of body weight lowering was not so much diminished in the moderate impairment group . Furthermore , a scatter plot showed that changes in HbA1c were more influenced by baseline HbA1c than by baseline eGFR . The incidence of AEs during 52 weeks was similar among all groups , with the majority being mild . IMPLICATION S Luseogliflozin improved glycemic control and reduced body weight in all eGFR groups , and its efficacy on HbA1c lowering was reduced in those with moderate renal impairment . Luseogliflozin was well tolerated and safe , with no significant safety issues identified , regardless of baseline eGFR . The study is registered with Clinical Trials Information/JapicCTI of the Japan Pharmaceutical Information Center , and the study registry identification numbers are JapicCTI-111507 , JapicCTI-111508 , JapicCTI-111509 , and JapicCTI-111543 Background Evidence concerning the importance of glucose lowering in the prevention of cardiovascular ( CV ) outcomes remains controversial . Given the multi-faceted pathogenesis of atherosclerosis in diabetes , it is likely that any intervention to mitigate this risk must address CV risk factors beyond glycemia alone . The SGLT-2 inhibitor empagliflozin improves glucose control , body weight and blood pressure when used as monotherapy or add-on to other antihyperglycemic agents in patients with type 2 diabetes . The aim of the ongoing EMPA-REG OUTCOME ™ trial is to determine the long-term CV safety of empagliflozin , as well as investigating potential benefits on macro-/microvascular outcomes . Methods Patients who were drug-naïve ( HbA1c ≥7.0 % and ≤9.0 % ) , or on background glucose-lowering therapy ( HbA1c ≥7.0 % and ≤10.0 % ) , and were at high risk of CV events , were r and omized ( 1:1:1 ) and treated with empagliflozin 10 mg , empagliflozin 25 mg , or placebo ( double blind , double dummy ) superimposed upon the st and ard of care . The primary outcome is time to first occurrence of CV death , non-fatal myocardial infa rct ion , or non-fatal stroke . CV events will be prospect ively adjudicated by an independent Clinical Events Committee . The trial will continue until ≥691 confirmed primary outcome events have occurred , providing a power of 90 % to yield an upper limit of the adjusted 95 % CI for a hazard ratio of < 1.3 with a one-sided α of 0.025 , assuming equal risks between placebo and empagliflozin ( both doses pooled ) . Hierarchical testing for superiority will follow for the primary outcome and key secondary outcomes ( time to first occurrence of CV death , non-fatal myocardial infa rct ion , non-fatal stroke or hospitalization for unstable angina pectoris ) where non-inferiority is achieved . Results Between Sept 2010 and April 2013 , 592 clinical sites r and omized and treated 7034 patients ( 41 % from Europe , 20 % from North America , and 19 % from Asia ) . At baseline , the mean age was 63 ± 9 years , BMI 30.6 ± 5.3 kg/m2 , HbA1c 8.1 ± 0.8 % , and eGFR 74 ± 21 ml/min/1.73 m2 . The study is expected to report in 2015 . Discussion EMPA-REG OUTCOME ™ will determine the CV safety of empagliflozin in a cohort of patients with type 2 diabetes and high CV risk , with the potential to show cardioprotection . Trial registration Clinical trials.gov Aims We examined the efficacy , safety and tolerability of canagliflozin , a sodium glucose co-transporter 2 inhibitor , in Japanese patients with type 2 diabetes ( T2DM ) undergoing diet and exercise therapy . Methods Patients aged 20–80 years with T2DM diagnosed ≥3 months previously , and HbA1c of 6.9–9.9 % were r and omized to 50 , 100 , 200 or 300 mg canagliflozin or placebo once daily for 12 weeks . The primary and secondary endpoints were changes in HbA1c , fasting plasma glucose ( FPG ) , urinary glucose/creatinine and postpr and ial glycaemic parameters following a meal test . The safety assessment s included adverse events ( AEs ) and clinical laboratory tests . Results Overall , 383 patients were r and omized to receive either placebo ( n = 75 ) , or 50 mg ( n = 82 ) , 100 mg ( n = 74 ) , 200 mg ( n = 77 ) or 300 mg canagliflozin ( n = 75 ) . At week 12 , significant reductions in HbA1c were observed in all canagliflozin groups relative to placebo ( −0.61 , –0.80 , –0.79 and −0.88 % for 50 , 100 , 200 and 300 mg , respectively , versus + 0.11 % for placebo ; all , p < 0.01 ) . FPG and postpr and ial glycaemic parameters improved significantly in the canagliflozin groups . Body weight was significantly decreased by canagliflozin . No deaths or drug-related serious AEs were reported . There was no dose-dependent increase in the incidence of AEs in the canagliflozin groups . The incidence of hypoglycaemia was low ; episodes were not severe or dose dependent . Canagliflozin did not affect serum creatinine levels or the urinary albumin/creatinine ratio . Conclusions Treatment with canagliflozin for 12 weeks significantly improved glycaemic control and reduced body weight in Japanese patients with T2DM . Canagliflozin was well tolerated Background As a first-line diabetes drug that is widely prescribed around the world , metformin has been demonstrated to be effective in reducing microvascular risk , in addition to lowering glucose levels . Specifically , metformin use has been shown to be associated with improved lipid profiles , such as increased levels of high-density lipoprotein cholesterol ( HDL-C ) . However , no study has been performed to examine the differential response in HDL-C levels to metformin treatment by race/ethnicity . Methods Here , based on a re- analysis of the data from the Diabetes Prevention Program , which involved pre-diabetic participants receiving 850 mg of metformin twice daily , we compared the lipid profile changes following the metformin use . The participants were composed of 602 Whites , 221 African Americans ( AAs ) and 162 Hispanics . Results We found that the one-year metformin treatment result ed in a significant increase in HDL-C levels in Whites ( p = 0.002 ) and AAs ( p = 0.016 ) , but not in Hispanics . Consistently , both Whites ( p = 0.018 ) and AAs ( p = 0.020 ) had more pronounced changes in HDL-C levels than Hispanics following metformin treatment . Conclusion This result suggests a notion that Whites and AAs are more responsive than Hispanics to one-year metformin use in HDL-C level changes , and that racial and ethnic identity is a factor to consider when interpreting the effects of metformin treatment on lipid profiles Introduction This study was design ed to determine the efficacy and tolerability of empagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus ( T2DM ) . Methods Patients with glycosylated hemoglobin ( HbA1c ) ≥7.0–≤10 % were r and omized via an interactive web response system , and treated double-blind with empagliflozin 5 , 10 , 25 , 50 mg , or placebo once daily for 12 weeks . The primary endpoint was change from baseline in HbA1c at week 12 . Other endpoints included percentage of patients with HbA1c < 7.0 % and changes from baseline in fasting plasma glucose ( FPG ) , body weight , and systolic blood pressure ( SBP ) at week 12 . Results A total of 547 patients were r and omized and treated with empagliflozin 5 mg ( n = 110 ) , 10 mg ( n = 109 ) , 25 mg ( n = 109 ) , 50 mg ( n = 110 ) , or placebo ( n = 109 ) for 12 weeks . Adjusted mean [ 95 % confidence interval ( CI ) ] differences vs. placebo in changes from baseline in HbA1c were −0.72 % ( −0.87 , −0.57 ) with empagliflozin 5 mg , −0.70 % ( −0.85 , −0.55 ) with 10 mg , −0.95 % ( −1.10 , −0.80 ) with 25 mg , and −0.91 ( −1.06 , −0.76 ) with 50 mg ( all p < 0.001 ) . More patients with HbA1c ≥7.0 % at baseline reached HbA1c < 7.0 % with empagliflozin ( 19–33 % ) than placebo ( 3 % ) . Compared with placebo , empagliflozin reduced FPG , body weight ( p < 0.001 for all doses for both endpoints ) and SBP ( p = 0.001 , p = 0.014 and p = 0.003 for empagliflozin 10 , 25 , and 50 mg , respectively ) . Adverse events were reported by 42 % of patients receiving placebo and 33–38 % of patients receiving empagliflozin . There were few reports of confirmed hypoglycemic adverse events or events consistent with urinary tract infection or genital infection in any treatment group . Conclusions Empagliflozin monotherapy for 12 weeks in Japanese patients with T2DM reduced HbA1c , FPG , body weight and SBP , and was well tolerated SUMMARY Abstract Background Combination therapy with canagliflozin and insulin was investigated in a prescribed sub study of the canagliflozin Cardiovascular Assessment Study ( CANVAS ) ; however , it was not evaluated in Japanese patients with type 2 diabetes mellitus ( T2DM ) . Since the usage profile of insulin therapy and pathologic features of Japanese patients differ from those of Caucasian patients , we determined the clinical benefit of such a combination therapy in Japanese patients . Methods Patients who had inadequate glycemic control despite insulin , diet and exercise therapies were
Output:
| SGLT2is significantly improved HbA1c [ mean difference - 0.80 ( 95%CI - 0.96 to - 0.64)% , p < 0.00001 ] , TG [ mean difference - 16.42 ( 95%CI - 22.71 to - 10.12 ) mg/dL , p < 0.00001 ] , and HDL-C [ mean difference 3.36 ( 95%CI 2.73 to 3.98 ) mg/dL , p < 0.00001 ] , but significantly deteriorated LDL-C [ mean difference 3.00 ( 95%CI 1.18 to 4.82 ) mg/dL , p < 0.001 ] .
Conclusion The present results suggest that in Asian patients with type 2 diabetes mellitus , TG and HDL-C values were better , while LDL-C values were worse with SGLT2is than with a placebo .
However , the negative impact of SGLT2is on lipid profiles was modest .
The present results will be informative for SGLT2is users with concerns regarding the effects of SGLT2is on lipid profiles |
MS211846 | ***TASK*** the task is to summarize an input biomedical literature 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 determine whether racial/ethnic differences in colon cancer screening are independent of socioeconomic and personal risk factors . DESIGN Baseline cross-section for a prospect i ve cohort . METHOD We recruited adults between 2000 and 2002 to undergo a question naire and venipuncture to study cancer risks . RESULTS Among 5595 adults over 50 years old , 40.3 % reported sigmoidoscopy or colonoscopy within the prior five years ; rates were 48.0 % for Whites , 32.8 % for Blacks , 27.9 % for Hispanics , 30.3 % for Asians , and 33.3 % for others . Adjusting for age , gender , access to care ( as income and insurance ) , and risk profile ( as cancer in family , smoking , and obesity ) , Blacks and Hispanics were less likely to have been screened than Whites . CONCLUSIONS Screening for colon cancer is low , especially among racial/ethnic minorities . Sociocultural factors merit closer attention CONTEXT A 1990 National Institutes of Health Consensus Conference recommended that patients with stage III colon cancer receive adjuvant chemotherapy because survival was improved in clinical trials in patients who received a 5-fluorouracil-based regimen . OBJECTIVE To determine whether adjuvant chemotherapy is used in the community as a st and ard of practice that improves outcome and whether it failed to benefit any specific sets of patients . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve data from 85 934 patients with stage III colon cancer from 560 hospital cancer registries were entered into the National Cancer Data Base between 1990 and 2002 and included st and ard clinical , pathological , and first course of treatment variables . MAIN OUTCOME MEASURES Prevalence of adjuvant chemotherapy usage and 5-year survival in patients treated in US hospitals . RESULTS Adjuvant chemotherapy use increased from 39 % in 1991 to 64 % in 2002 but was lower in black , female , and elderly patients . It improved 5-year survival from almost 8 % in 1991 to more than 16 % in 1997 compared with surgery alone . Adjuvant chemotherapy increases survival in elderly patients as much as it does in younger patients . However , the benefit of adjuvant chemotherapy in blacks and those with high- grade cancers is not as great . CONCLUSIONS Adjuvant chemotherapy use has increased from 1990 to 2002 for patients with stage III colon cancer with an associated increase in 5-year survival of 16 % . The benefit of adjuvant chemotherapy seems to be lower in black patients and high- grade cancers . Women have the same benefit but are less often treated . Elderly patients have the same benefit as younger patients but are less frequently treated . New options for adjuvant therapy in 2004 - 2005 may further improve the outcome of patients with stage III colon cancer Background : Evidence about the accuracy of self-reports of colorectal cancer ( CRC ) screening is lacking . We conducted a validation protocol in a r and omized trial to increase CRC screening among high-risk individuals . Methods : First-degree relatives ( n = 1,280 ) of CRC cases who were due for CRC screening were included in the parent trial . All subjects who completed the follow-up interview ( n = 948 ) were asked to participate in validation activities . Self-reports of receipt of CRC screening during the 12-month study period were verified via physicians . Results : Although 60 % ( n = 567 ) verbally agreed , only 171 subjects ( 18 % of original sample ) returned the signed validation form with the physician name and contact information and a medical information release statement . The signed forms were mailed to physicians with a $ 10 incentive and the request to list the date s of recent CRC screening tests . One hundred twenty-three physicians ( 72 % of physicians contacted , 13 % of original sample ) returned completed validation forms . Rates of agreement were low across all three screening types with physicians verifying self-reported screening for 29 % of fecal occult blood testing , 56 % of sigmoidoscopy , 55 % of colonoscopy , and 57 % of any screening test . Conclusion : Validation of self-report using the type of protocol we used for subjects receiving medical care in many community setting s may be unfeasible and cost inefficient . Given the overall low participation rate in validation activities and considerable challenges in collecting high quality data , conclusions about the accuracy of self-reported CRC screening are difficult to make based on the results of this study . ( Cancer Epidemiol Biomarkers Prev 2008;17(4):791–8 Colorectal cancer is the second leading cause of cancer death in the United States.1 Appropriate screening can reduce incidence of and mortality from colorectal cancer.2–5 The US Preventive Services Task Force recommends that all average-risk individuals aged 50 years and older receive colorectal cancer screening.6 The American Cancer Society recommends several acceptable approaches to screening , including an annual 3-card home fecal occult blood test.7 The Healthy People 2010 objective is to increase the proportion of people aged 50 and older who have received a fecal occult blood test within the preceding 2 years to at least 50%.8 Lack of knowledge , confidence , and skills ; negative attitudes toward the tests themselves ; fear of the consequences of screening ; and inadequate social support all have been suggested as possible barriers to colorectal cancer screening,9 whereas positive attitudes toward colorectal cancer screening and physician encouragement have been associated with receipt of a fecal occult blood test with a home stool kit.10 Despite these studies , gaps remain in what is known about barriers to successful interventions to increase colorectal cancer screening , particularly in minority population s.11,12 This study is based on the assumption that identification and definition of barriers to colorectal cancer screening in low-income , underserved minority population s can help guide the development of effective interventions Abstract The present study was design ed to assess ethnic disparities in CRC screening rates in a low-income population and to examine factors that could account for those differences . Participants were r and omly selected and asked to complete a question naire about CRC screening . After controlling for gender , age , education , income , health insurance , and family history of CRC , differences in screening rates as a function of ethnicity remained . Physicians ' recommendations and perceived efficacy of screening were also strong predictors of CRC screening . Psychological factors accounted in part for differences in screening rates between European Americans and Mexican Americans Colorectal carcinoma ranks as the second most common cancer and the second leading cause of cancer death in the United States . Hispanics are less likely than their non‐Hispanic white counterparts to have ever received a fecal occult blood test ( FOBT ) or sigmoidoscopy/colonoscopy . Little is known about the barriers to screening in the Hispanic population Background : Diabetics have been found to have a greater risk of colorectal cancer than non-diabetics . Methods : We examined whether this relationship differed by ethnic group , cancer site or tumour stage in a population -based prospect i ve cohort , including 3549 incident colorectal cancer cases identified over a 13-year period ( 1993–2006 ) among 199 143 European American , African American , Native Hawaiian , Japanese American and Latino men and women in the Multiethnic Cohort . Results : Diabetics overall had a significantly greater risk of colorectal cancer than did non-diabetics ( relative risk (RR)=1.19 , 95 % confidence interval (CI)=1.09–1.29 , P-value (P)<0.001 ) . Positive associations were observed for colon cancer , cancers of both the right and left colon , and cancers diagnosed at a localised and regional/distant stage . The association with colorectal cancer risk was significantly modified by smoking status ( PInteraction=0.0044 ) , with the RR being higher in never smokers ( RR=1.32 , 95 % CI=1.15–1.53 , P<0.001 ) than past ( RR=1.19 , 95 % CI=1.05–1.34 , P=0.007 ) and current smokers ( RR=0.90 , 95 % CI=0.70–1.15 , P=0.40 ) . Conclusion : These findings provide strong support for the hypothesis that diabetes is a risk factor for colorectal cancer Objective : There is evidence that non-English speakers in the United States receive lower quality health care and preventive services than English speakers . We tested the hypothesis that Spanish-speaking women would respond differently to an intervention to increase up-to- date status for cancer screening . Study Design and Setting : A multisite r and omized controlled trial showed that scripted telephone support , provided by a Prevention Care Manager ( PCM ) , increased up-to- date rates for breast , cervical , and colorectal cancer screening . This subgroup analysis investigated the relative efficacy of the PCM among women who chose to communicate with the PCM in Spanish versus English . Results : Of 1,346 women in this analysis , 63 % were Spanish speakers . Whereas the PCM intervention increased cancer screening rates generally , Spanish-speaking women seemed to benefit disproportionately more than English-speaking women for cervical cancer screening ( unadjusted odds ratio , 1.77 ; 95 % confidence interval , 1.03 - 3.05 ) . In addition , in this exploratory analysis , there was a trend toward Spanish-speaking women receiving more benefit than English-speaking women from the intervention in increased breast and colorectal cancer screening rates . Conclusion : Spanish-speaking women seemed to benefit more than did English-speaking women from a bilingual telephone support intervention aim ed at increasing cancer screening rates . ( Cancer Epidemiol Biomarkers Prev 2007;16(10):2058–64 Background This paper presents the study design , intervention components , and baseline data from Open Doors to Health , a study design ed to address social context ual factors in colorectal cancer ( CRC ) prevention for low-income , racial/ethnic minority population s. Methods A cluster r and omized design with 12 housing sites as the primary sampling units was used : 6 sites were assigned to a " Peer-led plus Screening Access " ( PL ) condition , and 6 were assigned to " Screening Access only " ( SCR ) condition . Study -related outcomes were CRC screening , physical activity ( measured as mean steps/day ) , and multivitamin use . Results At baseline ( unweighted sample size = 1554 ) , two-thirds self-reported that they were current with screening recommendations for CRC ( corrected for medical records validation , prevalence was 52 % ) , with half having received a colonoscopy ( 54 % ) ; 96 % had health insurance . Mean steps per day was 5648 ( se mean = 224 ) , and on average 28 % of the sample reported regular multivitamin use . Residents reported high levels of social support [ mean = 4.40 ( se = .03 ) ] and moderately extensive social networks [ mean = 2.66 ( se = .02 ) ] . Conclusion Few studies have conducted community-based studies in public housing communities ; these data suggest areas for improvement and future opportunities for intervention development and dissemination . Findings from the r and omized trial will determine the effectiveness of the intervention on our health-related outcomes as well as inform future avenues of research OBJECTIVE Health promotion efforts directed at Latinos may be more effective when culturally adapted methods are used . Our study was design ed to test a novel communication modality for promoting colorectal cancer ( CRC ) prevention and screening messages among Latinos . METHODS We compared a culturally aligned , brief storytelling educational intervention ( ST ) to a numeric risk tool intervention ( NR ) based on the Harvard Cancer Risk Index . Both interventions included risk factor information and recommendations for primary prevention and screening for CRC . Sixty-four Latinos ( mean age 46.8 , 86 % female ) were r and omized and completed pre- and post-tests . RESULTS Participants in ST indicated intent to add significantly more servings of vegetables ( p=.030 ) and more minutes of exercise ( p=.018 ) to daily routines than those in NR . Most respondents ( ST and NR ) reported intentions to recommend CRC screening to friends and relatives . CONCLUSIONS These data provide support for storytelling 's potential to promote health behavior change with cultural relevance for Latinos . PRACTICE IMPLICATION S Storytelling shows promise as an effective method for reaching one of the historically underserved ethnic groups with cancer prevention and screening information Background Minority racial/ethnic groups have low colorectal cancer ( CRC ) screening rates . Objective To evaluate a culturally tailored intervention to increase CRC screening , primarily using colonoscopy , among low income and non-English speaking patients . Design R and omized controlled trial conducted from January to October of 2007 . Setting Single , urban community health center serving a low-income , ethnically diverse population . Patients A total of 1,223 patients 52 - 79 years of age overdue for CRC screening , r and omized to intervention ( n = 409 ) vs. usual care control ( n = 814 ) groups . InterventionIntervention patients received an introductory letter with educational material followed by phone or in-person contact by a language -concordant “ navigator . ” Navigators ( n = 5 ) were community health workers trained to identify and address patient-reported barriers to CRC screening . Individually tailored interventions included patient education , procedure scheduling , translation and explanation of bowel preparation , and help with transportation and insurance coverage . Rates of colorectal cancer screening were assessed for intervention and usual
Output:
| There is great inconsistency in reported characteristics of Hispanics in health research . |
MS211847 | ***TASK*** the task is to summarize an input biomedical literature 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 objectives of this study were to examine the effects of diabetes during pregnancy on the long-term motor development of the offspring and to study possible correlations between glycemic control and motor development . We compared the motor development of 57 children , 5- to 12-years-of-age , born to 48 mothers with well-controlled diabetes , to the motor development of 57 control children matched by age , birth order , and parental socio-economic status . Children born to mothers with diabetes performed less well than controls in fine and gross motor functions on the Bruininks-Oseretsky Test of Motor Proficiency . A negative correlation existed between the test scores of the children whose mothers had diabetes and the severity of hyperglycemia as assessed by blood glycosylated hemoglobin levels and acetonuria . Motor ability of the children of mothers with diabetes had a high correlation with biological and environmental variables . These results suggest that diabetes during pregnancy may affect the developing brain , inducing long-term mild motor deficiency . The effects seem to result from the adverse effects of diabetic metabolic factors , and the effects correlate with the degree of diabetes control . The combination of metabolic functioning of women with diabetes and home environment may affect the motor development of their children PURPOSE The purpose of this study was to evaluate the Hunter Illawarra Kids Challenge Using Parent Support physical activity program in overweight children . METHODS A multisite r and omized controlled trial was conducted with three intervention arms : 1 ) child-centered physical activity skill development program ( Activity ) , 2 ) parent-centered dietary modification program ( DIET ) , or 3 ) both programs combined ( PA+DIET ) . Movement skill proficiency , perceived athletic competence , accelerometer-assessed physical activity , and parent-reported time spent in screen behaviors were assessed at baseline , 6 months , and 12 months in 165 prepubertal children aged 5.5 - 9 yr ( 59 % girls , 78 % obese ) . Differences in changes in outcomes between groups were assessed using linear mixed models . RESULTS Compared with the diet group , the activity group ( mean ( 95 % confidence interval ) : + 7.7 units ( 3.8 - 11.6 units ) ) and the activity + diet group ( + 6.7 units ( 2.9 - 10.5 units ) ) displayed 11%-13 % greater improvement in overall movement skill proficiency ( gross motor quotient ) at 6 months . Perceived athletic competence increased across groups at follow-up ( across groups : 6 months = + 0.21 units ( 0.11 - 0.31 units ) , 12 months = + 0.21 units ( 0.07 - 0.35 units ) ) . Groups did not differ statistically for change in physical activity outcomes . Total screen time ( min·wk(-1 ) ) decreased in all groups at 6 months ( across groups : -385.4 ( -501.0 to -269.8 ) ) and in the activity group ( -261.8 ( -470.5 to -53.1 ) ) and activity + diet group ( -340.5 ( -534.6 to -146.4 ) ) at 12 months . The diet group reported greater reductions in TV or DVD viewing time at 6 months compared with the activity group ( 248.6 ( 24.0 - 473.3 ) ) . CONCLUSIONS The activity and the activity + diet programs were efficacious in improving overweight children 's movement skill proficiency . All programs were efficacious in reducing time spent in screen behaviors . Other correlates may need to be targeted in addition to movement skills to increase physical activity among overweight children Differences in the age of attainment of motor skills between boys and girls have been established in previous studies . It has been noted that boys develop ball skills earlier than girls and that girls acquire manual dexterity before boys . The purpose of this study was to determine if the same differences could be identified in a group of typically developing seven and eight year old children using the Movement Assessment Battery for Children Test ( MABC Test ) . In this study , a physiotherapist administered the MABC Test to 103 r and omly selected children ( boys-60 , girls-43 ) . The MABC Test examines children 's motor skills in the areas of manual dexterity , ball skills and balance . Results were analyzed using analysis of variance ( ANOVA ) . The ANOVA results indicated significant differences between boys ' and girls ' ball skill scores and manual dexterity scores PURPOSE To test for relationships between objective ly measured habitual physical activity and fundamental movement skills in a relatively large and representative sample of preschool children . METHODS Physical activity was measured over 6 d using the Computer Science and Applications ( CSA ) accelerometer in 394 boys and girls ( mean age 4.2 , SD 0.5 yr ) . Children were scored on 15 fundamental movement skills , based on the Movement Assessment Battery , by a single observer . RESULTS Total physical activity ( r=0.10 , P<0.05 ) and percent time spent in moderate to vigorous physical activity ( MVPA ) ( r=0.18 , P<0.001 ) were significantly correlated with total movement skills score . Time spent in light-intensity physical activity was not significantly correlated with motor skills score ( r=0.02 , P>0.05 ) . CONCLUSIONS In this sample and setting , fundamental movement skills were significantly associated with habitual physical activity , but the association between the two variables was weak . The present study questions whether the widely assumed relationships between motor skills and habitual physical activity actually exist in young children AIM The objective of this study was to determine relationships between body composition and motor and physical competence of Grade 1 learners living in the North West Province of South Africa . METHODS Data were collected by means of a stratified r and om sampling procedure from 816 Grade 1 learners ( 419 boys , 397 girls ) with a mean age of 6.84 years ( + 0.39 SD ) , in the NW-CHILD- study . Height , weight , skinfolds ( subscapular , triceps , calf ) and waist circumference were measured . International cut-off values were used to classify the subjects in normal , overweight or obese categories . Motor and physical competence was measured by using the Bruiniks-Oseretsky Test of Motor Proficiency-2 SF and the Test of Gross Motor Development 2 . RESULTS One out of 10 learners were overweight or obese . Fine motor precision , balance , running speed and agility and strength correlated significantly with BMI with no clear relationships with object control skills and upper limb-coordination . CONCLUSION A clear relationship was found between body composition and most of the motor and physical fitness competencies of Grade 1 learners . Intervention strategies to improve the body composition of overweight children and accompanying motor proficiency back logs and physical fitness deficiencies are recommended PURPOSE Physical activity ( PA ) declines dramatically during adolescence , and activity levels are consistently lower among children living in low-income communities . Competency in a range of fundamental movement skills ( FMS ) may serve as a protective factor against the decline in PA typically observed during adolescence . The purpose of this study was to evaluate the effect of a 12-month multicomponent PA and FMS intervention on children attending primary schools in low-income communities . METHODS The Supporting Children 's Outcomes using Rewards , Exercise , and Skills intervention was evaluated using a cluster r and omized controlled trial . The sample included 25 classes from eight primary schools located in low-income communities . Participants were 460 children ( 54.1 % girls ) age 8.5 ± 0.6 yr . Primary outcomes were objective ly measured PA ( ActiGraph GT3X and GT3X+ accelerometers ) , FMS competency ( Test of Gross Motor Development 2 , six locomotor and six object control skills ) , and cardiorespiratory fitness ( 20-m multistage fitness test ) assessed at baseline , midprogram ( 6-months ) , and at posttest ( 12 months ) . Linear mixed models , adjusted for sex , age , body mass index z-score , socioeconomic status , ethnicity , and school class as a r and om factor , were used to assess the effect of the intervention . RESULTS At midprogram , there were no significant intervention effects for any of the outcomes . At posttest ( study 's primary time point ) , there were intervention effects for daily moderate-to-vigorous PA ( MVPA ) ( adjusted mean difference , 12.7 min·d of MVPA ; 95 % confidence interval ( CI ) , 5.0 - 20.5 ) , overall FMS competency ( 4.9 units ; 95 % CI , -0.04 to 9.8 ) , and cardiorespiratory fitness ( 5.4 laps ; 95 % CI , 2.3 - 8.6 ) . CONCLUSIONS A school-based multicomponent PA and FMS intervention maintained daily MVPA , improved overall FMS competency , and increased cardiorespiratory fitness among children attending primary schools in low-income communities
Output:
| The most examined correlates were biological and demographic factors .
Age ( increasing ) was a correlate of children ’s motor competence .
Weight status ( healthy ) , sex ( male ) and socioeconomic background ( higher ) were consistent correlates for certain aspects of motor competence only .
Physical activity and sport participation constituted the majority of investigations in the behavioral attributes and skills category .
Whilst we found physical activity to be a positive correlate of skill composite and motor coordination , we also found indeterminate evidence for physical activity being a correlate of object control or locomotor skill competence .
Indeed our findings do suggest that evidence for some correlates differs according to how motor competence is operationalized |
MS211848 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To evaluate the efficacy of different antipyretic agents and their highest recommended doses for preventing febrile seizures . DESIGN R and omized , placebo-controlled , double-blind trial . SETTING Five hospitals , each working as the only pediatric hospital in its region . PARTICIPANTS A total of 231 children who experienced their first febrile seizure between January 1 , 1997 , and December 31 , 2003 . The children were observed for 2 years . INTERVENTIONS All febrile episodes during follow-up were treated first with either rectal diclofenac or placebo . After 8 hours , treatment was continued with oral ibuprofen , acetaminophen , or placebo . MAIN OUTCOME MEASURE Recurrence of febrile seizures . RESULTS The children experienced 851 febrile episodes , and 89 of these included a febrile seizure . Febrile seizure recurrences occurred in 54 of the 231 children ( 23.4 % ) . There were no significant differences between the groups in the main measure of effect , and the effect estimates were similar , as the rate was 23.4 % ( 46 of 197 ) in those receiving antipyretic agents and 23.5 % ( 8 of 34 ) in those receiving placebo ( difference , 0.2 ; 95 % confidence interval , -12.8 to 17.6 ; P = .99 ) . Fever was significantly higher during the episodes with seizure than in those without seizure ( 39.7 degrees C vs 38.9 degrees C ; difference , 0.7 degrees C ; 95 % confidence interval , -0.9 degrees C to -0.6 degrees C ; P < .001 ) , and this phenomenon was independent of the medication given . CONCLUSIONS Antipyretic agents are ineffective for the prevention of recurrences of febrile seizures and for the lowering of body temperature in patients with a febrile episode that leads to a recurrent febrile seizure A descriptive profile for antipyretic drug action has been documented for children . However , a linked pharmacokinetic – pharmacodynamic ( PK/PD ) model is central to the underst and ing of antipyretic drug action in febrile children . This was examined for previously reported data from 178 febrile children who received a single oral dose of acetaminophen ( APAP ) ( 12.5 mg/kg ) , ibuprofen ( IBU ) ( 5 or 10 mg/kg ) , or placebo . Rectal temperatures and plasma levels ( μg/ml ) of APAP and IBU were measured for up to 12 hr after drug administration . Nonlinear regression analyses were applied to these measurements and yielded simultaneous solutions of an integrated one-compartment PK , link , and SigmoidEmaxeffect model in 102/153 febrile children given APAP or IBU . The PK parameters ( tlag , ka , β , T1/2β , AUC0–∞,Vd/F , and Clp/F ) were not different than those reported previously , except the APAPkawas significantly lower . The link component yieldedkeos of 0.58±0.06 ( X±SE ) , 0.70±0.11 and 0.57 ± 0.11 hr-1for APAP , IBU05 , and IBU10 , respectively : the SigmoidEmaxcomponent yieldedEC50s ( μg/ml ) and sigmoidicity ( γ ) of 4.63±0.39 and 3.98±0.42 for APAP , 11.33±1.35 and 3.97±0.58 for IBU05 and 12.83±1.89 and 4.27±0.63 for IBU10 . On visual inspection of the efficacy – time profiles of the febrile children , a number of them had an apparent linear function ( slope ; Δ ° C/hr ) and /or a sinusoidal cyclic function “ confounding ” st and ard approaches to PD analysis . Thus , the temperature profiles of 91/102 children given APAP or IBU required the addition of a slope ( Δ ° C/hr ) and /or a sinusoidal cyclic function to the SigmoidEmaxcomponent to fit the data satisfactorily . All 22 children given a placebo also required a slope and /or a cyclic function in their PD model . The residual Δ ° Cs ( observed-predicted ) of the placebo group were not significantly different from 0 . Thus , no placebo antipyretic effect was observed . Dose dependency of IBUAUC0–∞was confirmed ; doubling the dose from 5 to 10 mg/kg increased theAUC0→∞by only 1.5-fold . The confounding effect of initial temperature ( Tempi ) on antipyretic efficacy in all treatment groups except placebo was also confirmed to expose nonlinear pharmacodynamics . A significant ( p=0.03 ) contribution ofTempi(but not age ) on the value of the slope function was found . There was no consistent effect of age orTempi , on the cyclic component of the integrated model of antipyresis . In addition , a multiple linear relationship of age and Tempiwas observed with a large number of the PK , link , and PD variables in those who received IBU . Dose , age , and Tempiinteracted with β in a significant multiple linear relationship withAUC0–∞. The effects of IBU dose , age , and Tempiare pervasive and cascade down the chain of events leading to the PD response . The etiology of pyresis may create the slope function , the magnitude of which may be partially due to the underlying disease . In some cases , the cyclic function may be explained by temperature regulation . Regardless of their cause , both confound analysis of drug action and make the simple , unmodified SigmoidEMaxeffect model less than satisfactory for interpretation of antipyretic drug effects . The influence of Tempion the magnitude of antipyretic drug response is also a finding with major impact on PD investigations of antipyretic medications . In children receiving IBU , dose and age are also confounders , in addition toTempi . A multiplicity of covariables must be taken into account when developing appropriate dosing regimens for these antipyretics in febrile children BACKGROUND Many pediatricians recommend , and many parents administer , alternating or combined doses of ibuprofen and acetaminophen for fever . Limited data support this practice with st and ard US doses . OBJECTIVE This study compared the antipyretic effect of 3 different treatment regimens in children , using either ibuprofen alone , ibuprofen combined with acetaminophen , or ibuprofen followed by acetaminophen over a single 6-hour observation period . METHODS Febrile episodes from children aged 6 to 84 months were r and omized into the 3 treatment groups : a single dose of ibuprofen at the beginning of the observation period ; a single dose of ibuprofen plus a single dose of acetaminophen at the beginning of the observation period ; or ibuprofen followed by acetaminophen 3 hours later . Ibuprofen was administered at 10 mg/kg ; acetaminophen at 15 mg/kg . Temperatures were measured hourly for 6 hours using a temporal artery thermometer . The primary outcome was temperature difference between treatment groups . Adverse-event data were not collected in this single treatment period study . RESULTS Sixty febrile episodes in 46 children were assessed . The mean ( SD ) age of the children was 3.4 ( 2.2 ) years , and 31 ( 51.7 % ) were girls . Differences among temperature curves were significant ( P < 0.001 ; the combined and alternating arms had significantly better antipyresis compared with the ibuprofen-alone group at hours 4 to 6 ( hour 4 , P < 0.005 ; hours 5 and 6 , P < 0.001 ) . All but one of the children in the combined and alternating groups were afebrile at hours 4 , 5 , and 6 . In contrast , for those receiving ibuprofen alone , 30 % , 40 % , and 50 % had temperatures > 38.0 ° C at hours 4 , 5 , and 6 , respectively ( hour 4 , P = 0.002 ; hours 5 and 6 , P < 0.001 ) . CONCLUSION During a single 6-hour observation period for these participating children , combined and alternating doses of ibuprofen and acetaminophen provided greater antipyresis than ibuprofen alone at 4 to 6 hours . Clinical Trials.gov identifier : NCT00267293 A comparison of different antipyretics in children with malaria showed a small effect of naproxen , but not of metamizol , on the reduction of fever peaks . Antipyretic treatment had no effect on fever clearance and therefore should be used cautiously in the treatment of malaria Purpose LATIN is a multinational case – control study design ed to identify risk factors for agranulocytosis and to estimate the incidence rate of the disease in some Latin American countries . Methods Each study site in Brazil , Argentina and Mexico conducted an active search of agranulocytosis patients in hematology clinics and looked for possible associations with drug use . Results The overall incidence rate was 0.38 cases per 1 million inhabitant – years . Agranulocytosis patients more often took medications already associated with agranulocytosis than controls ( p = 0.01 ) , mainly methimazole ( OR 44.2 , 95 % CI 6.8 to infinity ) . The population attributable risk percentage ( etiologic fraction ) was 56 % . The use of nutrient supplements was more frequent among patients than controls ( p = 0.03 ) . Conclusions Agranulocytosis seems to be very rare in Latin America . The lower than expected number of cases identified during the study period precluded estimation of the risk associated to individual drugs , with the exception of methimazol . However , this is the longest series of agranulocytosis cases ever gathered in Latin America , and information on drug exposures was collected prospect ively . The conclusion is that drug-induced agranulocytosis does not seem to be a major public health problem in the study regions OBJECTIVE To compare the antipyretic benefit of acetaminophen or ibuprofen monotherapy with an alternating regimen of both drugs in young children aged 6 to 36 months . DESIGN R and omized , double-blind , parallel-group trial . SETTING Three primary pediatric community ambulatory centers in central Israel . PARTICIPANTS A total of 464 children aged 6 to 36 months with fever . INTERVENTION Infants were assigned to receive either acetaminophen ( 12.5 mg/kg per dose every 6 hours ) ( n = 154 ) or ibuprofen ( 5 mg/kg per dose every 8 hours ) ( n = 155 ) or to receive alternating acetaminophen and ibuprofen ( every 4 hours ) ( n = 155 ) for 3 days after a loading dose . MAIN OUTCOME MEASURES Temperature , stress score , amount of antipyretic received , total days that the infant or caregiver was absent from day care or work , respectively , at the 3-day time point , recurrence of fever , and number of emergency department visits . RESULTS The group given the alternating regimen was characterized by a lower mean temperature , more rapid reduction of fever , receiving less antipyretic medication , less stress , and less absenteeism from day care as compared with the other groups ; all of the differences were statistically significant ( P < .001 ) . None of the regimens were associated with a significantly higher number of emergency department visits ( P = .65 ) or serious long-term complications ( P = .66 ) . The drug used for initial loading had no effect on outcome in any of the groups . CONCLUSIONS An alternating treatment regimen of acetaminophen ( 12.5 mg/kg per dose ) and ibuprofen ( 5 mg/kg per dose ) every 4 hours for 3 days , regardless of the initial loading medication , is more effective than monotherapy in lowering fever in infants and children The antipyretic effect of nimesulide has not been adequately compared with paracetamol and ibuprofenparacetamol combination in children . Hence , a r and omized , double blind , and parallel groups ’ design and multicenter study was conducted on children with respiratory tract infections . Eighty-nine patients with temperatures above 38.5 ° C were r and omly administered nimesulide ( 1.5 mgJkgJdose ) , paracetamol ( 10.0 mgJkgJdose ) , or ibuprofen- patients combination ( 10.0 mgJkgJdose ) , thrice daily for five days . The axillary temperature was recorded at the baseline and at different time intervals post administration of drugs . The hematological and biochemical investigations were performed at the basal level and at the end of the treatment period . The adverse drug reactions were monitored during the trial . All the drugs produced a significant fall in temperature as compared to their respective basal values ( p<0.001 ) . However , on looking at the change in temperatures at different time intervals from the respective basal levels , no significant difference was found among all the drugs . Surprisingly , nimesulide had a tendency to raise serum glutamate pyruvate transaminase and serum glutamate oxaloacetate transaminase levels as compared to its baseline values . There was no marked adverse effect of the drugs on other hematological and biochemical parameters investigated . No other serious adverse reaction occurred in the study . Ibuprofen-paracetamol combination , nimesulide , and paracetamol had almost similar antipyretic effects in children Abstract Objective : To compare the effectiveness and rate of temperature reduction of three antipyretic medications in febrile children . Design :
Output:
| Overall , the articles pointed to a tendency of lower mean temperatures in groups with alternating therapy .
Few adverse effects were reported .
Although there was a tendency towards the reduction of mean temperatures with alternating antipyretics compared to the use of one antipyretic alone , there is not enough evidence to say that alternating antipyretic therapy is more effective than monotherapy |
MS211849 | ***TASK*** the task is to summarize an input biomedical literature 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 prevalence rate of ascariasis in primary school children in northern Jakarta , Indonesia varies from 60 % to 90 % . An association between helminthic infection and educational achievement has long been recognized . This study was carried out in the northern part of Jakarta among primary school children 6 - 8 years of age . Treatment of ascariasis and health education were used as the interventions . Before the interventions , basic data on socioeconomic status , epidemiology , infection with Ascaris lumbricoides , nutritional status , and cognitive function were collected . After the interventions , only data on infection with A. lumbricoides , nutritional status , and cognitive function were collected . The children were divided into five groups . Group I was given an anthelminthic ( mebendazole ) , group II was provided with health education , group III was given an antihelminthic and provided with health education , group IV was given a placebo ( controls ) , and group V consisted of egg-negative children , who also served as controls . Data from 336 students were analyzed by analysis of covariance . Parasitologic examinations showed a mean prevalence rate of 58.4 % for A. lumbricoides infection in the pre-intervention children and a mean prevalence rate of 40.6 % in the post-intervention children . Concerning nutritional status , approximately 80 % of the children showed good scores in the pre- and post-treatment data , and only a small percentage ( 0.9 - 16.2 % ) showed mild or moderate malnutrition . No significant difference was found between the pre- and post-treatment nutritional status . The results of the cognitive test showed that the group treated with mebendazole showed significant improvement in the Colored Progressive Matrices and Coding test . Children also showed an improvement in their learning ability , concentration , and eye-h and coordination after five months of receiving this intervention We studied growth in infected children given one dose ( 600 mg ) or two doses of albendazole per school year . Children were examined and allocated at r and om within sex by descending hookworm egg count to one of three groups : placebo ( n = 93 ) , one dose ( 1x , n = 96 ) or two doses ( 2x , n = 95 ) . Each child was treated and then re-examined and treated 3.6 and 8.2 mo later ( Exams 2 and 3 ) . The 1x and 2x groups gained significantly more by Exam 3 than the placebo group in weight ( 1.1 and 0.9 kg more , respectively ) , percent weight-for-age ( 3.3 and 2.7 percentage points more ) , percent weight-for-height ( 3.1 and 2.9 percentage points more ) , percent arm circumference-for-age ( 2.3 and 2.0 percentage points more ) and triceps and subscapular skinfolds but did not differ significantly from each other . The placebo group showed significant decreases between exams ( P < 0.0002 ) in percent weight-for-age and percent arm circumference-for-age and no change in percent weight-for-height , whereas the 1x and 2x groups exhibited significant increases ( P < 0.005 ) . At Exam 3 , arithmetic mean egg reduction rates for the 1x and 2x groups were 84 and 95 % for hookworm , 42 and 32 % for Trichuris and 55 and 87 % for Ascaris , respectively . We conclude that one or two doses of albendazole per year result ed in similar growth improvements , despite reinfection , in school-age children in an area where these helminths and poor growth are prevalent We studied physical fitness with the Harvard Step Test , growth , and appetite in primary school boys infected with hookworm ( 96 % baseline prevalence ) , Trichuris trichiura ( 98 % prevalence ) and Ascaris lumbricoides ( 41 % prevalence ) who received a single 600-mg dose of albendazole or an identical placebo . Boys were examined , allocated at r and om within pairs by descending hookworm egg count to placebo ( n = 26 ) or albendazole ( n = 27 ) groups , treated , and re-examined 4 mo later . Four months after treatment , the albendazole group showed highly significant improvements in fitness score , resting heart rate , and heart rates at 1 , 2 , 3 and 4 min after the Harvard Step Test , whereas the placebo group had not changed significantly . The albendazole group also exhibited significantly more rapid growth judged by weight gain ( 1.0 kg greater than the placebo group , P < 0.0002 ) , height increment ( 0.6 cm more , P < 0.003 ) , arm circumference ( 0.3 cm more , P < 0.0002 ) , and triceps and subscapular skinfolds ( 1.0 mm more , P < 0.0002 ) , and showed improved appetite with objective and subjective measures . We conclude that single-dose treatment with albendazole can allow improved physical fitness , growth , and appetite in school-age children in areas where these helminths and poor growth are highly prevalent A r and omized controlled trial was conducted in eastern Zaire to assess the effects of high dose vitamin A supplementation and regular deparasitation on the growth of 358 moderately malnourished preschool children , discharged from the hospital . The treatment groups received either vitamin A ( 60 mg of oily solution of retinyl palmitate , 30 mg if aged < 12 mo ) every 6 mo or mebendazole ( 500 mg ) every 3 mo ; the control group received no supplementation . Anthropometric data were gathered at baseline and after 6 and 12 mo of follow-up . Serum retinol concentrations were measured at baseline and after 3 mo . The three groups did not differ in sociodemographic indicators , age and sex composition , nutritional status and serum retinol concentrations at baseline . In children who were vitamin A deficient at baseline , adjusted mean weight and mid-upper arm circumference ( MUAC ) increments were higher in the vitamin A-supplemented group than in the control group [ annual increment in weight and MUAC in vitamin A vs. control group : 2.088 vs. 1.179 kg ( P = 0.029 ) and 2.24 vs. 0.95 cm ( P = 0.012 ) , respectively ] , whereas growth increment did not differ between the dewormed group and the control group . In children who were not vitamin A deficient at baseline , growth increment did not differ between the vitamin A-supplemented and control groups , whereas weight gain was lower in the dewormed group than in the control group . Vitamin A-supplemented boys gained more weight and height than control boys , whereas vitamin A-supplemented girls gained less height than control girls . Dewormed boys and girls gained less weight than control boys and girls . Programs to improve vitamin A status by high dose vitamin A supplementation may improve growth of preschool children who are vitamin A deficient , whereas deworming does not We evaluated the effects of the Zanzibar school-based deworming program on the iron status of primary school children . Parasitologic and nutritional assessment s were carried out at baseline , 6 mo , and 12 mo in 4 nonprogram schools ( n = 1002 ) , 4 schools in which students received twice-yearly deworming ( n = 952 ) , and 4 schools in which students received thrice-yearly deworming ( n = 970 ) with 500 mg generic mebendazole . Schools were r and omly selected for evaluation and allocated to program groups . Relative to no treatment , thrice-yearly deworming caused significant decreases in protoporphyrin concentrations and both deworming regimens caused marginally significant increases in serum ferritin concentrations . The average annual changes in protoporphyrin concentrations were -5.9 and -23.5 micromol/mol heme in the control and thrice-yearly deworming groups , respectively ( P < 0.001 ) . The average changes in ferritin concentration were 2.8 and 4.5 microg/L , respectively ( P = 0.07 ) . Deworming had no effect on annual hemoglobin change or prevalence of anemia . However , the relative risk of severe anemia ( hemoglobin < 70 g/L ) was 0.77 ( 95 % confidence limits : 0.39 , 1.51 ) in the twice-yearly deworming group and 0.45 ( 0.19 , 1.08 ) in the thrice-yearly deworming group . The effects on prevalence of high protoporphyrin values and incidence of moderate-to-severe anemia ( hemoglobin < 90 g/L ) were significantly greater in children with > 2000 hookworm eggs/g feces at baseline . We estimate that this deworming program prevented 1260 cases of moderate-to-severe anemia and 276 cases of severe anemia in a population of 30,000 schoolchildren in 1 y. Where hookworm is heavily endemic , deworming programs can improve iron status and prevent moderate and severe anemia , but deworming may be needed at least twice yearly One-hundred eighty-five Bangladeshi children age 1 1/2 to 8 yr with no Ascaris lumbricoides infection or with light , moderate , or heavy infection were r and omly assigned to treatment of placebo groups , with treatment given in a double-blind fashion . The groups were comparable for nutritional and socioeconomic parameters . Treatment consisted of a single dose of piperazine citrate administered twice within a 2-wk period . The cure rates for the low , moderate , and heavy A. lumbricoides infected subgroups were 53 , 31 , and 36 % , respectively . With more severe infections , worm eradication was more difficult and the rate of reinfection after treatment was more rapid . The rate of reinfection was significantly different for the low A. lumbricoides infected treatment and placebo subgroups for 5 months after treatment , for the moderate treatment and placebo subgroups for 3 months after treatment , and for the heavy A. lumbricoides infected treatment and placebo subgroups there was a difference , although not significant , for 1 month after treatment . Anthropometric measurements were obtained for a period of 11 months . Analysis of covariance revealed no significant difference for change of weight , change of height , weight-for age , weight-for-height , height-for-age , triceps skinfold , midarm circumference , and the abdominal girth to chest circumference ratio between the treatment and placebo groups after drug administration . The results of this study do not support single dose worm therapy as a means to enhance growth Growth , activity , appetite and intestinal helminth infections were compared for 55 Kenyan primary school children with hookworm ( 93 % prevalence ) , T. trichiura ( 84 % prevalence ) and A. lumbricoides ( 29 % prevalence ) before and 9 wk after treatment with three 400-mg doses of albendazole ( Zentel ) or placebo . Fecal sample s were examined for helminth eggs using a modified Kato technique . Activity was measured during free-play with motion recorders on the dominant thigh . Children rated their appetites on a 5-point scale . After baseline measurements , children were r and omly allocated to the albendazole-treated ( n = 28 ) and placebo ( n = 27 ) groups , treated , and re-examined 9 wk later . At follow-up , egg counts were significantly lower than at baseline in the albendazole-treated group ( P < or = 0.002 ) , and gains in activity , reported appetite and most indices of growth were significantly greater for the albendazole-treated group than for the placebo group . We conclude that treatment of undernourished school children for intestinal helminth infections with albendazole may improve growth and appetite and increase spontaneous physical activity One hundred fifty-nine children aged 24 to 61 months with 60 % ascariasis prevalence and 21.5 % giardiasis prevalence in rural Guatemala were studied prospect ively for 1 yr . They were divided into four groups comparable for age , sex , socioeconomic status , and past growth experience as judged by slopes of height and weight on age . Each group was r and omly assigned to the following 2-monthly treatment regimens : group I , placebo , group II , piperazine , group III , metronidazole ; group IV , piperazine and metronidazole . Height and weight were measured every 3 months and stools were examined for parasites every 4 months . Piperazine administration decreased the prevalence of ascariasis to 33.8 % at the end of the study but growth remained unaltered . Metronidazole administration decreased the prevalence of giardiasis to 2.5 % at the end of the study and was accompanied by increased growth as judged by delta weight , delta % weight for age , slope of weight on age , delta height , delta % height for age and slope of height on age . It is suggested that failure of antiascaris treatment to enhance growth in this study may be because of 1 ) absence of severe malnutrition in the subjects , 2 ) adequacy of dietary protein , 3 ) possible low worm load , and 4 ) failure to eradicate ascariasis . The findings suggest that giardiasis is associated with reduced growth in preschool children The effects of treating Trichuris trichiura infections were investigated in 407 Jamaican children age 6 to 12 y. The children were r and omly assigned to receive treatment ( albendazole ) or a placebo . The outcome variables included growth , tests of reading , spelling and arithmetic , and school attendance . After 6 mo of treatment ,
Output:
| There is some limited evidence that routine treatment of children in areas where helminths are common has effects on weight gain , but this is not consistent between trials .
There is insufficient evidence as to whether this intervention improves cognitive performance |
MS211850 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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***EXAMPLES***
Input: BACKGROUND Blockade of programmed death 1 ( PD-1 ) , an inhibitory receptor expressed by T cells , can overcome immune resistance . We assessed the antitumor activity and safety of BMS-936558 , an antibody that specifically blocks PD-1 . METHODS We enrolled patients with advanced melanoma , non-small-cell lung cancer , castration-resistant prostate cancer , or renal-cell or colorectal cancer to receive anti-PD-1 antibody at a dose of 0.1 to 10.0 mg per kilogram of body weight every 2 weeks . Response was assessed after each 8-week treatment cycle . Patients received up to 12 cycles until disease progression or a complete response occurred . RESULTS A total of 296 patients received treatment through February 24 , 2012 . Grade 3 or 4 drug-related adverse events occurred in 14 % of patients ; there were three deaths from pulmonary toxicity . No maximum tolerated dose was defined . Adverse events consistent with immune-related causes were observed . Among 236 patients in whom response could be evaluated , objective responses ( complete or partial responses ) were observed in those with non-small-cell lung cancer , melanoma , or renal-cell cancer . Cumulative response rates ( all doses ) were 18 % among patients with non-small-cell lung cancer ( 14 of 76 patients ) , 28 % among patients with melanoma ( 26 of 94 patients ) , and 27 % among patients with renal-cell cancer ( 9 of 33 patients ) . Responses were durable ; 20 of 31 responses lasted 1 year or more in patients with 1 year or more of follow-up . To assess the role of intratumoral PD-1 lig and ( PD-L1 ) expression in the modulation of the PD-1-PD-L1 pathway , immunohistochemical analysis was performed on pretreatment tumor specimens obtained from 42 patients . Of 17 patients with PD-L1-negative tumors , none had an objective response ; 9 of 25 patients ( 36 % ) with PD-L1-positive tumors had an objective response ( P=0.006 ) . CONCLUSIONS Anti-PD-1 antibody produced objective responses in approximately one in four to one in five patients with non-small-cell lung cancer , melanoma , or renal-cell cancer ; the adverse-event profile does not appear to preclude its use . Preliminary data suggest a relationship between PD-L1 expression on tumor cells and objective response . ( Funded by Bristol-Myers Squibb and others ; Clinical Trials.gov number , NCT00730639 . ) 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 The development of human cancer is a multistep process characterized by the accumulation of genetic and epigenetic alterations that drive or reflect tumour progression . These changes distinguish cancer cells from their normal counterparts , allowing tumours to be recognized as foreign by the immune system . However , tumours are rarely rejected spontaneously , reflecting their ability to maintain an immunosuppressive microenvironment . Programmed death-lig and 1 ( PD-L1 ; also called B7-H1 or CD274 ) , which is expressed on many cancer and immune cells , plays an important part in blocking the ‘ cancer immunity cycle ’ by binding programmed death-1 ( PD-1 ) and B7.1 ( CD80 ) , both of which are negative regulators of T-lymphocyte activation . Binding of PD-L1 to its receptors suppresses T-cell migration , proliferation and secretion of cytotoxic mediators , and restricts tumour cell killing . The PD-L1–PD-1 axis protects the host from overactive T-effector cells not only in cancer but also during microbial infections . Blocking PD-L1 should therefore enhance anticancer immunity , but little is known about predictive factors of efficacy . This study was design ed to evaluate the safety , activity and biomarkers of PD-L1 inhibition using the engineered humanized antibody MPDL3280A . Here we show that across multiple cancer types , responses ( as evaluated by Response Evaluation Criteria in Solid Tumours , version 1.1 ) were observed in patients with tumours expressing high levels of PD-L1 , especially when PD-L1 was expressed by tumour-infiltrating immune cells . Furthermore , responses were associated with T-helper type 1 ( TH1 ) gene expression , CTLA4 expression and the absence of fractalkine ( CX3CL1 ) in baseline tumour specimens . Together , these data suggest that MPDL3280A is most effective in patients in which pre-existing immunity is suppressed by PD-L1 , and is re-invigorated on antibody treatment Purpose : The aberrant expression of programmed cell death 1 lig and s 1 and 2 ( PD-Ls ) on tumor cells dampens antitumor immunity , result ing in tumor immune evasion . In this study , we investigated the expression of PD-Ls in human hepatocellular carcinoma ( HCC ) to define their prognostic significance after curative surgery . Experimental Design : Immunohistochemistry was used to investigate PD-Ls expression as well as granzyme B+ cytotoxic and FoxP3 + regulatory T cell infiltration on tissue microarrays containing 240 r and omly selected HCC patients who underwent surgery . The results were further verified in an independent cohort of 125 HCC patients . PD-Ls expression on HCC cell lines was detected by Western blot assay . Results : Patients with higher expression of PD-L1 had a significantly poorer prognosis than patients with lower expression . Although patients with higher expression of PD-L2 also had a poorer survival , the difference in recurrence was not statistically significant . Multivariate analysis identified tumor expression of PD-L1 as an independent predictor for postoperative recurrence . No correlation was found between PD-Ls expression and granzyme B+ lymphocyte infiltration , whereas a significant positive correlation was detected between PD-Ls expression and FoxP3 + lymphocyte infiltration . In addition , tumor-infiltrating cytotoxic and regulatory T cells were also independent prognosticators for both survival and recurrence . The prognostic value of PD-L1 expression was vali date d in the independent data set . Conclusion : Our data suggest for the first time that PD-L1 status may be a new predictor of recurrence for HCC patients and provide the rationale for developing a novel therapy of targeting the PD-L1/PD-1 pathway against this fatal malignancy BACKGROUND Programmed death 1 ( PD-1 ) protein , a T-cell coinhibitory receptor , and one of its lig and s , PD-L1 , play a pivotal role in the ability of tumor cells to evade the host 's immune system . Blockade of interactions between PD-1 and PD-L1 enhances immune function in vitro and mediates antitumor activity in pre clinical models . METHODS In this multicenter phase 1 trial , we administered intravenous anti-PD-L1 antibody ( at escalating doses ranging from 0.3 to 10 mg per kilogram of body weight ) to patients with selected advanced cancers . Anti-PD-L1 antibody was administered every 14 days in 6-week cycles for up to 16 cycles or until the patient had a complete response or confirmed disease progression . RESULTS As of February 24 , 2012 , a total of 207 patients --75 with non-small-cell lung cancer , 55 with melanoma , 18 with colorectal cancer , 17 with renal-cell cancer , 17 with ovarian cancer , 14 with pancreatic cancer , 7 with gastric cancer , and 4 with breast cancer -- had received anti-PD-L1 antibody . The median duration of therapy was 12 weeks ( range , 2 to 111 ) . Grade 3 or 4 toxic effects that investigators considered to be related to treatment occurred in 9 % of patients . Among patients with a response that could be evaluated , an objective response ( a complete or partial response ) was observed in 9 of 52 patients with melanoma , 2 of 17 with renal-cell cancer , 5 of 49 with non-small-cell lung cancer , and 1 of 17 with ovarian cancer . Responses lasted for 1 year or more in 8 of 16 patients with at least 1 year of follow-up . CONCLUSIONS Antibody-mediated blockade of PD-L1 induced durable tumor regression ( objective response rate of 6 to 17 % ) and prolonged stabilization of disease ( rates of 12 to 41 % at 24 weeks ) in patients with advanced cancers , including non-small-cell lung cancer , melanoma , and renal-cell cancer . ( Funded by Bristol-Myers Squibb and others ; Clinical Trials.gov number , NCT00729664 . )
Output:
| These results suggest that expression of PD-L1 is associated with worse survival in solid tumors .
However , the correlations between PD-L1 and prognosis are variant among different tumor types . |
MS211851 | ***TASK*** the task is to summarize an input biomedical literature 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 long-term effectiveness of a structured health education program ( HEP ) for spouses and frail older adults was evaluated in a staff model health maintenance organization ( HMO ) . HEP is a multicomponent group program that includes emotion-focused and problem-focused coping strategies , education , and support . For caregivers , HEP was more effective than usual care ( UC ) in reducing depression , increasing knowledge of community services and how to access them , and changing caregivers ' feelings of competence and the way they respond to the caregiving situation . For care recipients , HEP was more effective than UC in preventing increases in somatic symptoms and symptoms of anxiety/insomnia . ( ( c ) 2004 APA , all rights reserved Abstract Objective To evaluate the efficacy of two internet interventions for community-dwelling individuals with symptoms of depression — a psychoeducation website offering information about depression and an interactive website offering cognitive behaviour therapy . Design R and omised controlled trial . Setting Internet users in the community , in Canberra , Australia . Participants 525 individuals with increased depressive symptoms recruited by survey and r and omly allocated to a website offering information about depression ( n = 166 ) or a cognitive behaviour therapy website ( n = 182 ) , or a control intervention using an attention placebo ( n = 178 ) . Main outcome measures Change in depression , dysfunctional thoughts ; knowledge of medical , psychological , and lifestyle treatments ; and knowledge of cognitive behaviour therapy . Results Intention to treat analyses indicated that information about depression and interventions that used cognitive behaviour therapy and were delivered via the internet were more effective than a credible control intervention in reducing symptoms of depression in a community sample . For the intervention that delivered cognitive behaviour therapy the reduction in score on the depression scale of the Center for Epidemiologic Studies was 3.2 ( 95 % confidence interval 0.9 to 5.4 ) . For the “ depression literacy ” site ( BluePages ) , the reduction was 3.0 ( 95 % confidence interval 0.6 to 5.2 ) . Cognitive behaviour therapy ( MoodGYM ) reduced dysfunctional thinking and increased knowledge of cognitive behaviour therapy . Depression literacy ( BluePages ) significantly improved participants ' underst and ing of effective evidence based treatments for depression ( P < 0.05 ) . Conclusions Both cognitive behaviour therapy and psychoeducation delivered via the internet are effective in reducing symptoms of depression Abstract Objectives : To determine the acceptability of two psychological interventions for depressed adults in the community and their effect on caseness , symptoms , and subjective function . Design : A pragmatic multicentre r and omised controlled trial , stratified by centre . Setting : Nine urban and rural communities in Finl and , Republic of Irel and , Norway , Spain , and the United Kingdom . Participants : 452 participants aged 18 to 65 , identified through a community survey with depressive or adjustment disorders according to the international classification of diseases , 10th revision or Diagnostic and Statistical Manual of Mental Disorders , fourth edition . Interventions : Six individual sessions of problem solving treatment ( n=128 ) , eight group sessions of the course on prevention of depression ( n=108 ) , and controls ( n=189 ) . Main outcome measures : Completion rates for each intervention , diagnosis of depression , and depressive symptoms and subjective function . Results : 63 % of participants assigned to problem solving and 44 % assigned to prevention of depression completed their intervention . The proportion of problem solving participants depressed at six months was 17 % less than that for controls , giving a number needed to treat of 6 ; the mean difference in Beck depression inventory score was −2.63 ( 95 % confidence interval −4.95 to −0.32 ) , and there were significant improvements in SF-36 scores . For depression prevention , the difference in proportions of depressed participants was 14 % ( number needed to treat of 7 ) ; the mean difference in Beck depression inventory score was −1.50 ( −4.16 to 1.17 ) , and there were significant improvements in SF-36 scores . Such differences were not observed at 12 months . Neither specific diagnosis nor treatment with antidepressants affected outcome . Conclusions : When offered to adults with depressive disorders in the community , problem solving treatment was more acceptable than the course on prevention of depression . Both interventions reduced caseness and improved subjective function Background .Depression is common in primary care , but rates of adequate care are low . Little is known about the role of patient treatment preferences in encouraging entry into care . Objectives .To examine whether a primary care based depression quality improvement ( QI ) intervention design ed to accommo date patient and provider treatment choice increases the likelihood that patients enter depression treatment and receive preferred treatment . Methods .In 46 primary care clinics , patients with current depressive symptoms and either lifetime or current depressive disorder were identified through screening . Treatment preferences , patient characteristics , and use of depression treatments were assessed at baseline and 6 months by patient self-report . Matched clinics were r and omized to usual care ( UC ) or 1 of 2 QI interventions . Data were analyzed using logistic regression models . Results .For patients not in care at baseline , the QI interventions increased rates of entry into depression treatment compared with usual care ( adjusted percentage : 50.0 % ± 5.3 and 33.0 % ± 4.9 for interventions vs. 15.9 % ± 3.6 for usual care ; F = 12.973 , P < 0.0001 ) . Patients in intervention clinics were more likely to get treatments they preferred compared with those in usual care ( adjusted percentage : 54.2 % ± 3.3 and 50.7 % ± 3.1 for interventions vs. 40.5 % ± 3.1 for usual care ; F = 6.034 , P < 0.003 ) ; however , in all clinics less than half of patients preferring counseling reported receiving it . Conclusions .QI interventions that support patient choice can improve the likelihood of patients receiving preferred treatments . Patient treatment preference appears to be related to likelihood of entering depression treatment , and patients preferring counseling may require additional interventions to enhance entry into treatment BACKGROUND Many people who are depressed do not receive any professional help and their beliefs about the helpfulness of treatment do not always correspond with those of health professionals . To facilitate choices about treatment , the present study examined the effects of providing depressed people in the community with evidence on whether various treatment options work . METHOD A r and omized controlled trial was carried out with 1094 persons selected at r and om from the community who screened positive for depressive symptoms and agreed to participate . Participants were mailed either an evidence -based consumer guide to treatments for depression or , as a control , a general brochure on depression . Outcomes were the rated usefulness of the information provided , changes in attitudes to depression treatments , actions taken to reduce depression , and changes in depressive symptoms , anxiety symptoms and disability . RESULTS Participants rated the evidence -based consumer guide as more useful than the control brochure . Attitudes to some treatments changed . Improvements in symptoms and disability did not differ significantly between interventions . CONCLUSION Providing people who are depressed with evidence on which treatments work produces some changes in attitudes and behaviour . However , this intervention may need to be enhanced if it is to produce symptom change The aim of this controlled study was to evaluate a 1-year learner-centred educational project in end-of-life care for home care staff in a rural district of Sweden . Another rural district in the same region served as a control area . A 20-item question naire measuring attitudes towards end-of-life care was design ed , and the Hospital Anxiety and Depression ( HAD ) scale was used to measure mental well being . Increased agreement to 18 of 20 attitude statements was seen in the education group , while 2 of 20 items showed a decreased agreement in the control group . Test retest reliability of the 20-item question naire was good ( r = 0.92 ) . The total HAD score decreased from 8.3 pretest to 5.3 post-test in the education group ( 95 % CI=2.1– 3.7 ; P<0.001 ) , and was 6.8 for both years in the control group . Our study shows that a comprehensive educational programme not only improved attitudes towards end-of-life care , but also the mental well being of the home care staff
Output:
| The primary outcome measure was significant improvement on the key depression measure .
Results Components which were found to significantly predict improvement were the revision of professional roles , the provision of a case manager who provided direct feedback and delivered a psychological therapy , and an intervention that incorporated patient preferences into care .
Nurse , psychologist and psychiatrist delivered care were effective , but pharmacist delivery was not .
Training directed to general practitioners was significantly less successful than interventions that did not have training as the most important intervention .
Community interventions were effective .
Conclusion Case management is important in the provision of care in general practice .
Certain community models of care ( education programs ) have potential while others are not successful in their current form ( pharmacist monitoring ) |
MS211852 | ***TASK*** the task is to summarize an input biomedical literature 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: AIMS To evaluate the effectiveness of a family-centred group education programme , in adolescents with Type 1 diabetes . METHODS Three hundred and five adolescents with Type 1 diabetes ; age 13.1 ± 1.9 years , diabetes duration 5.6 ± 3.3 years , BMI 20.9 ± 3.7 kg/m(2 ) , HbA(1c ) 78 ± 6 mmol/mol ( 9.3 ± 1.9 % ) were r and omly allocated to the Families and Adolescents Communication and Teamwork Study ( FACTS ) diabetes education programme ; ( six 90-min monthly sessions attended by parents and adolescents incorporating skills training and family teamwork ) or conventional clinical care . Primary outcome was HbA(1c ) at 18 months ( 12 months post-intervention ) . Secondary outcomes were HbA(1c ) at 9 months , psychosocial outcomes , adolescent quality of life , well-being , family responsibility and insulin dose adjustment behaviours at 12 months ( 6 months post-intervention ) and episodes of severe hypoglycaemia and diabetic ketoacidois during the 12 months post-intervention . All analyses are intention to treat . RESULTS Session attendance was poor with 48/158 families ( 30.4 % ) not attending any sessions and only 75/158 ( 47.5 % ) families attending ≥ 4 group education sessions . All biomedical and psychosocial outcomes were comparable between groups . At 18 months there was no significant difference in HbA(1c ) in either group and no between-group differences over time : intervention group 75 mmol/mol ( 9.0 % ) to 78 mmol/mol ( 9.3 % ) , control group 77 mmol/mol ( 9.2 % ) to 80 mmol/mol ( 9.5 % ) . Adolescents perceived no changes in parental input at 12 months . CONCLUSION Poor attendance of group education sessions delivered in routine clinics was a major challenge . More personalized educational approaches may be required to support and motivate families who are struggling to integrate the dem and s of intensive insulin regimens into their daily lives AIMS To assess Sweet Talk , a text-messaging support system design ed to enhance self-efficacy , facilitate uptake of intensive insulin therapy and improve glycaemic control in paediatric patients with Type 1 diabetes . METHODS One hundred and twenty-six patients fulfilled the eligibility criteria ; Type 1 diabetes for > 1 year , on conventional insulin therapy , aged 8 - 18 years . Ninety-two patients were r and omized to conventional insulin therapy ( n = 28 ) , conventional therapy and Sweet Talk ( n = 33 ) or intensive insulin therapy and Sweet Talk ( n = 31 ) . Goal - setting at clinic visits was reinforced by daily text-messages from the Sweet Talk software system , containing personalized goal -specific prompts and messages tailored to patients ' age , sex and insulin regimen . RESULTS HbA(1c ) did not change in patients on conventional therapy without or with Sweet Talk ( 10.3 + /- 1.7 vs. 10.1 + /- 1.7 % ) , but improved in patients r and omized to intensive therapy and Sweet Talk ( 9.2 + /- 2.2 % , 95 % CI -1.9 , -0.5 , P < 0.001 ) . Sweet Talk was associated with improvement in diabetes self-efficacy ( conventional therapy 56.0 + /- 13.7 , conventional therapy plus Sweet Talk 62.1 + /- 6.6 , 95 % CI + 2.6 , + 7.5 , P = 0.003 ) and self-reported adherence ( conventional therapy 70.4 + /- 20.0 , conventional therapy plus Sweet Talk 77.2 + /- 16.1 , 95 % CI + 0.4 , + 17.4 , P = 0.042 ) . When surveyed , 82 % of patients felt that Sweet Talk had improved their diabetes self-management and 90 % wanted to continue receiving messages . CONCLUSIONS Sweet Talk was associated with improved self-efficacy and adherence ; engaging a classically difficult to reach group of young people . While Sweet Talk alone did not improve glycaemic control , it may have had a role in supporting the introduction of intensive insulin therapy . Scheduled , tailored text messaging offers an innovative means of supporting adolescents with diabetes and could be adapted for other health-care setting s and chronic diseases Evaluated the effects of stress management training ( SMT ) for adolescents with diabetes in a 9-month controlled treatment- outcome study . Nine patients were r and omly assigned to a stress management group while another 10 patients served as controls and received st and ard outpatient treatment . The treatment program consisted of 10 sessions over 3 months , 3 additional sessions over 3 months , and a 3-month follow-up without treatment . Diabetes-specific stress decreased significantly for patients in the SMT group over the course of the intervention and follow-up . However , metabolic control , regimen adherence , coping styles , and self-efficacy about diabetes were unchanged . These findings suggest a SMT program for adolescents with diabetes may be helpful in reducing diabetes-specific stress , but additional procedures are necessary to improve adherence , coping styles , and metabolic control OBJECTIVE The objective of this study was to compare the relative effectiveness of two modes of delivering Behavioral Family Systems Therapy for Diabetes ( BFST-D ) to improve adherence and glycemic control among adolescents with type 1 diabetes with suboptimal glycemic control ( HbA1c ≥9.0 % [ ≥74.9 mmol/mol ] ) : face to face in clinic ( Clinic ) and Internet videoconferencing ( Skype ) conditions . RESEARCH DESIGN AND METHODS Adolescents aged 12 to 18 years and at least one adult caregiver were r and omized to receive BFST-D via the Clinic or Skype condition . Participants completed up to 10 therapy sessions within a 12-week period . Changes in youth- and parent-reported adherence and glycemic control were compared before and after the intervention and at follow-up assessment . RESULTS Using an intent-to-treat analytic approach , no significant between-group differences were identified between the before , after , and follow-up assessment s. Groups were collapsed to examine the overall effects of BFST-D on adherence and glycemic control . Results identified that statistically significant improvements in adherence and glycemic control occurred from before to after the intervention ; improvements were maintained at 3-month follow-up . CONCLUSIONS Delivery of BFST-D via Internet-based videoconferencing is viable for addressing nonadherence and suboptimal glycemic control in adolescents with type 1 diabetes , potentially reducing important barriers to care for youth and families OBJECTIVE : To test the effect on diabetes management outcomes of a low-intensity , clinic-integrated behavioral intervention for families of youth with type 1 diabetes . METHODS : Families ( n = 390 ) obtaining care for type 1 diabetes participated in a 2-year r and omized clinical trial of a clinic-integrated behavioral intervention design ed to improve family diabetes management practice s. Measurement of hemoglobin A1c , the primary outcome , was obtained at each clinic visit and analyzed central ly . Blood glucose meter data were downloaded at each visit . Adherence was assessed by using a semistructured interview at baseline , mid- study , and follow-up . Analyses included 2- sample t tests at predefined time intervals and mixed-effect linear-quadratic models to assess for difference in change in outcomes across the study duration . RESULTS : A significant overall intervention effect on change in glycemic control from baseline was observed at the 24-month interval ( P = .03 ) . The mixed-effect model showed a significant intervention by age interaction ( P < .001 ) . Among participants aged 12 to 14 , a significant effect on glycemic control was observed ( P = .009 for change from baseline to 24-month interval ; P = .035 for mixed-effect model across study duration ) , but there was no effect among those aged 9 to 11 . There was no intervention effect on child or parent report of adherence ; however , associations of change in adherence with change in glycemic control were weak . CONCLUSIONS : This clinic-integrated behavioral intervention was effective in preventing the deterioration in glycemic control evident during adolescence , offering a potential model for integrating medical and behavioral sciences in clinical care Background Few interventions have effectively improved health outcomes among youth with diabetes in chronic poor metabolic control . Purpose This study aims to determine whether multisystemic therapy ( MST ) , an intensive , home-based , tailored family treatment , was superior to weekly telephone support for improving regimen adherence and metabolic control among adolescents with chronic poor metabolic control . Methods A r and omized controlled trial was conducted with 146 adolescents with types 1 or 2 diabetes . Data were collected at baseline , 7 months ( treatment termination ) , and 12 months ( 6 months follow-up ) . Results Adolescents receiving MST had significantly improved metabolic control at 7 ( 1.01 % decrease ) and 12 months ( 0.74 % decrease ) compared to adolescents in telephone support . Parents of adolescents receiving MST reported significant improvements in adolescent adherence . However , adolescent-reported adherence was unchanged . Conclusions MST improved health outcomes among adolescents with chronic poor metabolic control when compared to telephone support . Home-based approaches may provide a viable means to improve access to behavioral interventions for such youth The purpose of this pilot study was to test the hypothesis that adolescents with type 1 diabetes can learn to become better problem solvers in diabetes self-care and thereby improve their metabolic control . METHODS Fifty-three adolescents aged 13 to 17 with type 1 diabetes were r and omly assigned to either a 6-week problem-solving diabetes education program or to a control group ( usual care ) . Al C levels were obtained as well as assessment s of problem solving , frequency of behavior , level of responsibility , and 24-hour behavior recall at baseline and 6 months . RESULTS The experimental group participants showed significantly improved problem-solving test scores and Al C values from baseline to 6 months , changes not evident in the control group . At 6 months , the experimental group participants were doing blood glucose testing more often than those in the control group . However , there was no significant difference in problem-solving test scores or Al C values . CONCLUSIONS This 6-week intervention for adolescents with diabetes result ed in better problem-solving skills , more frequent blood glucose testing , and improved Al C values . The results suggest that a diabetes problem-solving program for adolescents can be effective in improving metabolic control OBJECTIVE To examine the impact of a Cognitive Behavior Therapy (CBT)-based intervention on HbA(1c ) , self-care behaviors and psychosocial factors among poorly controlled adult type 1 diabetes patients . METHODS Ninety-four type 1 diabetes patients were r and omly assigned to either an intervention group or a control group . The intervention was based on CBT and was mainly delivered in group format , but individual sessions were also included . All subjects were provided with a continuous glucose monitoring system ( CGMS ) during two 3-day periods . HbA(1c ) , self-care behaviors and psychosocial factors were measured up to 48 weeks . RESULTS Significant differences were observed with respect to HbA(1c ) ( P<0.05 ) , well-being ( P<0.05 ) , diabetes-related distress ( P<0.01 ) , frequency of blood glucose testing ( P<0.05 ) , avoidance of hypoglycemia ( P<0.01 ) , perceived stress ( P<0.05 ) , anxiety ( P<0.05 ) and depression ( P<0.05 ) , all of which showed greater improvement in the intervention group compared with the control group . A significant difference ( P<0.05 ) was registered with respect to non-severe hypoglycemia , which yielded a higher score in the intervention group . CONCLUSION This CBT-based intervention appears to be a promising approach to diabetes self-management . PRACTICE IMPLICATION S Diabetes care may benefit from applying tools commonly used in CBT . For further scientific evaluation in clinical practice , there is a need for specially educated diabetes care teams , trained in the current approach , as well as cooperation between diabetes care teams and psychologists trained in CBT The feasibility of a family-based clinic-integrated behavioral intervention to improve family management of type 1 diabetes was evaluated . In each of four clinical sites , 30 - 32 families ( a total of 122 ) were r and omized to intervention or usual care comparison groups . The WE*CAN intervention , based on family problem-solving methods , was delivered during three routine clinic visits by trained ' Health Advisors ' . Of eligible families across the four sites , 83 % agreed to participate , of whom 96 % completed the baseline , mid-term , and postintervention assessment s. Families participated in an average of 2.85 intervention sessions over an 8-month period . The intervention was integrated into the clinic setting without impairing clinic flow
Output:
| For instance , intensive lowering of blood pressure has reduced major cardiovascular events by 11 % ( 6 ) . |
MS211853 | ***TASK*** the task is to summarize an input biomedical literature 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 Limited information is available about predictors of short-term outcomes in patients with exacerbation of chronic obstructive pulmonary disease ( e COPD ) attending an emergency department ( ED ) . Such information could help stratify these patients and guide medical decision-making . The aim of this study was to develop a clinical prediction rule for short-term mortality during hospital admission or within a week after the index ED visit . Methods This was a prospect i ve cohort study of patients with e COPD attending the EDs of 16 participating hospitals . Recruitment started in June 2008 and ended in September 2010 . Information on possible predictor variables was recorded during the time the patient was evaluated in the ED , at the time a decision was made to admit the patient to the hospital or discharge home , and during follow-up . Main short-term outcomes were death during hospital admission or within 1 week of discharge to home from the ED , as well as at death within 1 month of the index ED visit . Multivariate logistic regression models were developed in a derivation sample and vali date d in a validation sample . The score was compared with other published prediction rules for patients with stable COPD . Results In total , 2,487 patients were included in the study . Predictors of death during hospital admission , or within 1 week of discharge to home from the ED were patient age , baseline dyspnea , previous need for long-term home oxygen therapy or non-invasive mechanical ventilation , altered mental status , and use of inspiratory accessory muscles or paradoxical breathing upon ED arrival ( area under the curve ( AUC ) = 0.85 ) . Addition of arterial blood gas parameters ( oxygen and carbon dioxide partial pressures ( PO2 and PCO2 ) ) and pH ) did not improve the model . The same variables were predictors of death at 1 month ( AUC = 0.85 ) . Compared with other commonly used tools for predicting the severity of COPD in stable patients , our rule was significantly better . Conclusions Five clinical predictors easily available in the ED , and also in the primary care setting , can be used to create a simple and easily obtained score that allows clinicians to stratify patients with e COPD upon ED arrival and guide the medical decision-making process BACKGROUND AND OBJECTIVE Hospitalization for exacerbation of COPD is associated with a high risk of mortality . A risk-prediction model using information easily obtained on admission could help to identify high-risk individuals . The CURB65 score was developed to predict mortality risk in community acquired pneumonia . A retrospective study found that this score was also associated with mortality in COPD exacerbations . We conducted a prospect i ve study to assess the utility of the CURB65 score in acute COPD exacerbations . METHODS Consecutive patients with physician diagnosed COPD exacerbations admitted to a public hospital during a 1-year period were studied prospect ively . The CURB65 scores were calculated from information obtained at initial hospital presentation . CURB65 = one point each for Confusion , Urea > 7 mmol/L , Respiratory rate ≥ 30/min , low Blood pressure , age ≥ 65 years . RESULTS 30-day mortality data were available for 249 of 252 patients . CURB65 scores on admission significantly predicted risk of death during the hospital admission and at 30 days . The 30-day mortality by score groups were : low risk ( scores 0 - 1 ) 2.0 % ( 2/98 ) , moderate risk ( score 2 ) 6.7 % ( 6/90 ) and high risk ( scores 3 - 5 ) 21.3 % ( 13/61 ) . CURB65 scores were not predictive of 1-year mortality . CONCLUSIONS A simple 6-point score based on confusion , blood urea , respiratory rate , blood pressure and age can be used to stratify patients with COPD exacerbation into different management groups . The CURB65 score was as effective in predicting early mortality in our cohort of acute COPD exacerbations as it was in previous cohorts with community acquired pneumonia . Our findings suggest that CURB65 scores can help clinicians to assess patients with exacerbation of COPD The aim of the present prospect i ve multicentric study was to develop a simple rule for the prediction of poor outcome in patients presenting to emergency departments with initially non-life threatening-chronic obstructive pulmonary disease ( COPD ) exacerbations in a real-life setting . All patients with an acute exacerbation of COPD visiting the emergency departments of 103 hospitals during a 3-month period were included , except those who immediately required intensive care unit admission and /or ventilatory support . The data collected included patient characteristics , in-hospital outcomes ( mortality and length of stay ) and mode of discharge ( unsupported or need for post-hospital assistance ) . The in-hospital mortality rate was 7.4 % ( 59 out of 794 ) . Independent prognostic factors were age , number of clinical signs of severity ( among cyanosis , impaired neurological status , lower limb oedema , asterixis and use of accessory inspiratory or expiratory muscles ) and dyspnoea grade in the stable state . The need for post-hospital support was also predicted by female sex . In order to construct and vali date a prediction score for mortality based on these items , patients were r and omly allocated to a derivation and a validation cohort . The prediction score showed good discrimination , with a c-statistic of 0.79 in the derivation cohort and 0.83 in the validation cohort . Thus simple purely clinical factors can reliably predict the risk of death and requirement for post-hospital support in an initially non-life threatening-acute exacerbation of chronic obstructive pulmonary disease . Their use needs to be prospect ively vali date SETTING Reported predictors of the adverse evolution of patients with chronic obstructive pulmonary disease exacerbations ( e COPD ) are various and inconsistent in the bibliography . OBJECTIVE To develop clinical prediction rules for short-term outcomes in e COPD patients attending an emergency department ( ED ) . DESIGN Prospect i ve cohort study of patients with an e COPD . Short-term outcomes were admission to an intensive care unit ( ICU ) , admission to an intermediate respiratory care unit ( IRCU ) and death in these groups . Multivariate logistic regression models were developed for each of the outcomes . RESULTS Predictors of ICU or IRCU admission were use of long-term home oxygen therapy ( LT-HOT ) or non-invasive mechanical ventilation ( NIMV ) , elevated PCO2 and decreased pH upon ED arrival ( area under the curve [ AUC ] 0.87 in the derivation sample ; 0.89 in the validation sample ) . Among those admitted to an ICU or IRCU , predictors of death were increased age , use at home of LT-HOT or NIMV , use of inspiratory accessory muscles upon ED arrival and altered Glasgow Coma Scale ( < 15 points ) ( AUC 0.78 ) . CONCLUSIONS Three clinical predictors available in the ED can be used to create a simple score to predict the need for intensive treatment among e COPD patients . Such a score can be a tool for clinical practice Background The use of a severity score to help orientation decisions could improve the efficiency of care for acute exacerbations of COPD ( AE COPD ) . We previously developed a score ( ‘ 2008 score ’ , based on age , dyspnea grade at steady state and number of clinical signs of severity ) predicting in-hospital mortality in patients with AE COPD visiting emergency departments ( EDs ) . External validity of this score remained to be assessed . Objectives To test the predictive properties of the ‘ 2008 score ’ in a population of patients hospitalized in medical respiratory wards for AE COPD , and determine whether a new score specifically derived from this population would differ from the previous score in terms of components or predictive performance . Methods Data from a cohort study in 1824 patients hospitalized in a medical ward for an AE COPD were analyzed . Patients were categorized using the 2008 score and its predictive characteristics for in-hospital mortality rates were assessed . A new score was developed using multivariate logistic regression modeling in a r and omly selected derivation population sample followed by testing in the remaining population ( validation sample ) . Robustness of results was assessed by case-by-case validation . Results The 2008 score was characterized by a c-statistic at 0.77 , a sensitivity of 69 % and a specificity of 76 % for prediction of in-hospital mortality . The new score comprised the same variables plus major cardiac comorbidities and was characterized by a c-statistic of 0.78 , a sensitivity of 77 % and specificity of 66 % . Conclusions A score using simple clinical variables has robust properties for predicting the risk of in-hospital death in patients hospitalized for AE COPD . Adding cardiac comorbidities to the original score increased its sensitivity while decreasing its specificity Background In patients with acute hypercapnic respiratory failure ( AHRF ) during exacerbations of COPD , mortality can be high despite noninvasive ventilation ( NIV ) . For some , AHRF is terminal and NIV is inappropriate . However there is no definitive method of identifying patients who are unlikely to survive . The aim of this study was to identify factors associated with inpatient mortality from AHRF with respiratory acidosis due to COPD . Methods COPD patients presenting with AHRF and who were treated with NIV were studied prospect ively . The forced expiratory volume in 1 second ( FEV1 ) , World Health Organization performance status ( WHO-PS ) , clinical observations , a composite physiological score ( Early Warning Score ) , routine hematology and biochemistry , and arterial blood gases prior to commencing NIV , were recorded . Results In total , 65 patients were included for study , 29 males and 36 females , with a mean age of 71 ± 10.5 years . Inpatient mortality in the group was 33.8 % . Mortality at 30 days and 12 months after admission were 38.5 % and 58.5 % , respectively . On univariate analysis , the variables associated with inpatient death were : WHO-PS ≥ 3 , long-term oxygen therapy , anemia , diastolic blood pressure < 70 mmHg , Early Warning Score ≥ 3 , severe acidosis ( pH < 7.20 ) , and serum albumin < 35 g/L. On multivariate analysis , only anemia and WHO-PS ≥ 3 were significant . The presence of both predicted 68 % of inpatient deaths , with a specificity of 98 % . Conclusion WHO-PS ≥ 3 and anemia are prognostic factors in AHRF with respiratory acidosis due to COPD . A combination of the two provides a simple method of identifying patients unlikely to benefit from NIV The aim of this study was to develop and vali date a new method : a classification and regression tree ( CART ) based on easily accessible measures to predict mortality in patients with stable chronic obstructive pulmonary disease ( COPD ) . This was a prospect i ve study of two independent prospect i ve cohorts : a derivation cohort with 611 recruited patients and a validation cohort with 348 patients , all followed for 5 yrs . CART analysis was used to predict 5-yr mortality risk using the following covariates from the derivation cohort : age , % predicted forced expiratory volume in 1 s ( FEV1 ) , dyspnoea , physical activity , general health and number of hospital admissions for COPD exacerbations in the previous 2 yrs . Age ( ≥75 or < 75 yrs ) provided the first branch of the COPD -CART . The highest mortality risk ( 0.74 ) was seen in patients > 75 yrs of age with higher levels of dyspnoea and FEV1 < 50 % pred . Patients with the lowest risk of 5-yr mortality ( 0.04 ) were < 55 yrs of age with FEV1 > 35 % pred and one or no recent hospitalisations for COPD exacerbations . A simple decision tree that uses variables commonly gathered by physicians can provide a quick assessment of the severity of the disease , as measured by the risk of 5-yr mortality BACKGROUND Mortality rate , the possible factors affecting mortality and intubation in patients with acute exacerbation of chronic obstructive pulmonary diseases ( COPD ) and hypercapnic respiratory failure ( RF ) are yet unclear . OBJECTIVE To identify the possible factors affecting mortality and intubation in COPD patients . DESIGN A prospect i ve study using data obtained over the first 24h of respiratory intensive care unit ( RICU ) admission . Consecutive admissions of 656 patients were monitored and 151 of them who had acute exacerbation of COPD and hypercapnic RF were enrolled . SETTING University hospital , Department of Chest Diseases , RICU . RESULTS Mean age was 65.1 years . The mean APACHE II score was 23.7 . Eighty-seven patients ( 57.6 % ) received mechanical ventilation ( MV ) via an endotracheal tube for more than 24 h. Twenty-two patients received non-invasive ventilation ( NIV ) . Fifty patients died ( 33.1 % ) in hospital during the study period . The mortality rate was 52.9 % in patients in need of MV . In the multivariate analysis , the need for intubation , inadequate metabolic compensation for respiratory acidosis , and low ( = bad ) Glasgow Coma Score ( GCS ) were determined as independent factors associated with mortality . The low GCS ( OR : 0.61 ; CI : 0.48 - 0.78 ) and high APACHE II score ( OR : 1.24 ; CI
Output:
| This study constitutes a detailed mapping and assessment of the prognostic models for outcome prediction in COPD patients . |
MS211854 | ***TASK*** the task is to summarize an input biomedical literature 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 studies have shown unequivocally a lack of pituitary-adrenocortical stress hormone activation during lactate-induced panic attacks despite considerable psychopathological alterations , signs of arousal and several vegetative symptoms regularly occurring during stressful conditions . To study the possible inhibitory action of atrial natriuretic hormone ( ANH ) on adrenocorticotrophic hormone ( ACTH ) and cortisol release in humans , 10 patients with panic disorder ( DSM-III-R ) received sodium lactate and placebo ( 0.9 % saline ) infusions and ten healthy comparison subjects additionally received a 2.5 % saline infusion and the response of ANH , vasopressin , ACTH , cortisol , and several biochemical and physiological cardiovascular parameters were measured . In comparison to placebo , lactate infusion led to enhanced ANH levels in both non-panicking comparison subjects and panickers . Importantly , panickers showed significantly lower baseline levels of ANH than comparison subjects followed by a faster release . No significant concomitant changes in vasopressin , ACTH , and cortisol were observed . During lactate infusion , heart rate was accelerated considerably in the two groups ; in contrast , the reduction of pCO2 indicated an enhanced ventilation only in panickers . The pattern of ANH release can not be attributed simply to either the volume load administered , the cardiac activation or an osmotic effect since neither 0.9 nor 2.5 % saline result ed in comparable effects . Additional central nervous mechanisms must be considered for the increased ANH concentrations in lactate-induced panic attacks . We propose that the release of ANH is an intrinsic mechanism contributing to the apparent unresponsiveness of the pituitary-adrenocortical system in lactate-induced panic attacks . In addition , we surmise that ANH may also play a role in the yet unknown mechanisms for termination of panic attacks , e.g. either by inhibitory actions on the locus coeruleus or by bronchiorelaxation and consecutive decatastrophization Experiments design ed to establish the effects of video games on breathing patterns have led to contradictory results . Several authors reported that video games tended to increase breathing frequency ( i.e. to reduce breath duration ) , whereas others reported the opposite . We postulated that video games contain different psychophysiological components which may have opposite effects on breathing pattern . On the one h and , arousal and emotion may tend to stimulate breathing . On the other , focusing attention on the game may prompt subject to inhibit any movement -- including breathing -- which might be a potential nuisance variable . The aim of this study was to assess the specific effects of the attentional load in an experimental environment characterized by its low emotional impact . We measured breathing variables , cardiac frequency and cortisol levels in 10 healthy children ( mean age = 9.2 + /- 1.5 years ) who were familiar with the environment , the experimenter and the video game . Breath duration rose significantly , from 2.56 to 3.16 s , as a function of game difficulty . Cortisol levels , heart rate and the thoracic contribution to breathing displayed no significant changes . Taken together , these data suggest that focusing attention on the game tended to inhibit breathing and that previous contradictory reports in this respect were due to the confounding effects of emotion BACKGROUND Dysregulated respiratory control may play a role in the pathophysiology of panic disorder . This could be due to abnormalities in brain stem respiratory nuclei or to dysregulation at higher brain levels . Results from previous studies using the doxapram model of panic have yielded an unclear picture . A brief cognitive manipulation reduced doxapram-induced hyperventilation in patients , suggesting that higher level inputs can substantially alter their respiratory patterns . However , respiratory abnormalities persisted , including a striking irregularity in breathing patterns . METHODS To directly study respiratory irregularity , breath-by-breath records of tidal volume ( V(t ) ) and frequency ( f ) from previously studied subjects were obtained . Irregularity was quantified using von Neumann 's statistic and calculation of " sigh " frequency in 16 patients and 16 matched control subjects . Half of each group received a st and ard introduction to the study and half received a cognitive intervention design ed to reduce anxiety/distress responses to the doxapram injection . RESULTS Patients had significantly greater V(t ) irregularity relative to control subjects . Neither the cognitive intervention nor doxapram-induced hyperventilation produced significant changes in V(t ) irregularity . The V(t ) irregularity was attributable to a sighing pattern of breathing that was characteristic of panic patients but not control subjects . Patients also had somewhat elevated f irregularity relative to control subjects . CONCLUSIONS The irregular breathing patterns in panic patients appear to be intrinsic and stable , uninfluenced by induced hyperventilation or cognitive manipulation . Further study of V(t ) irregularity and sighs are warranted in efforts to localize dysregulated neural circuits in panic to brain stem or midbrain levels RATIONALE Psychologic factors are increasingly recognized to influence the onset and course of asthma . Previous cross-sectional community-based studies have provided evidence for a relatively specific association between asthma and panic . OBJECTIVES To examine concurrent and longitudinal associations between asthma and panic in young adults . MEASUREMENTS AND MAIN RESULTS Prospect i ve community-based cohort study of young adults ( n = 591 ) followed between ages 19 and 40 . Information was derived from six subsequent semistructured diagnostic interviews conducted by professionals . Cross-sectionally ( over the whole study period ) , asthma was more strongly associated with panic disorder ( odds ratio [ OR ] = 4.0 ; 95 % confidence interval [ CI ] , 1.7 , 9.3 ) than with any panic , which included panic disorder and panic attacks ( OR = 2.1 ; 95 % CI , 1.1 , 4.5 ) . Longitudinally , after adjusting for potentially confounding variables , active asthma predicted subsequent panic disorder ( OR = 4.5 ; 95 % CI , 1.1 , 20.1 ) , and the presence of panic disorder predicted subsequent asthma activity ( OR = 6.3 ; 95 % CI , 2.8 , 14.0 ) . Asthma predicted any panic ( OR = 2.7 ; 95 % CI , 1.1 , 7.1 ) , whereas any panic did not predict subsequent asthma activity . Associations were stronger in smokers than in nonsmokers , and stronger in women than in men . Smoking , early-childhood anxiety , and a family history of allergy were important confounders of the asthma-panic association . CONCLUSIONS This is the first long-term follow-up study on asthma and panic . It showed dose-response-type relationships between panic and asthma , and bidirectional longitudinal associations between the two conditions . It provided evidence for familial factors and smoking as possible shared etiologic explanations Progesterone administration increase VE in man , but its effects on ventilatory response to hypercapnia and hypoxia have not been well documented . Accordingly , VE , HVR , and HCVR were measured during placebo and MPA administration in 11 normal men . The effect of MPA ( 20 mg orally q 8 hr for 32 hr ) on T degrees , metabolic rate ( VO2 and VCO2 ) was also determined . With MPA , T degrees , rose 0.4 degrees C + /- 0.0008 ( S.E.M. ) p less than 0.0001 ) , VE increased 0.46 + /- 0.16 L/min ( p less than 0.01 ) , and VO2 and VCO2 did not change significantly . HCVR ( measured under hyperoxic conditions during rebreathing ) increased significantly ( P less than 0.01 ) from 2.9 + /- 0.33 L/min/mm Hg ( placebo ) to 4.0 + /- 0.29 ( MPA ) . HVR was measured as the shape parameter A , so that when A increased , HVR was augmented . During MPA , HVR increased from A = 132 + /- 19.1 to 179 + /- 20.5 ( P less than 0.02 ) . We conclude that 60 mg of MPA daily in normal men increases VE and chemosensitivity as measured by the ventilatory response to hypercapnia and hypoxia The goals of this study were to a ) confirm prior evidence that the respiratory stimulant doxapram induces panic attacks and produces excessive hyperventilation in patients with panic disorder and b ) explore the impact of cognitive mediators on symptom and respiratory responses . Method : Thirty-two subjects ( 16 patients and 16 controls ) received doxapram ( 0.5 mg/kg ) and placebo infusions while symptom , respiratory , and heart rate responses were monitored . Subjects were r and omly assigned to receive either a st and ard introduction or a cognitive intervention design ed to reduce the panic responses of panic patients to laboratory challenges . Results : Doxapram was a potent and specific panicogenic agent , inducing panic in 75 % of patients and 12.5 % of controls . Compared with controls , patients also showed a greater decrease in end tidal carbon dioxide ( CO2 ) and greater increases in minute ventilation , respiratory frequency , and heart rate . The cognitive intervention substantially attenuated the excessive hyperventilatory response of patients but did not fully normalize their breathing patterns . Tidal volume was the only respiratory measure not significantly altered by the cognitive intervention . Conclusions : In patients with panic disorder , doxagram ( 0.5 mg/kg ) triggers panic attacks about as potently as 7 % CO2 and more potently than 5 % CO2 or lactate . Psychological factors can modulate the appearance of ventilatory abnormalities in panic patients , but persistent respiratory disturbances were still seen . Psychological factors and respiratory physiology both appear to be important phenomena in laboratory panic OBJECTIVE The authors assessed the substance and diagnostic specificity of carbon-dioxide-induced panic since , in addition to the specific biochemical effects of inhaled carbon dioxide ( CO2 ) , simple physiologic distress is also frequently implicated as a panicogenic factor during respiratory challenge studies with CO2 in patients with anxiety disorders . METHOD Eighteen patients with panic disorder , 20 with social phobia , and 23 psychiatrically normal subjects inhaled a mixture of 35 % CO2 and 65 % O2 for 30 seconds through a face mask . They also breathed for 30 seconds through a valve reducing the diameter of the airway . A double-blind , counterbalanced , r and omized design was used . RESULTS In spite of important similarities between the two interventions , including the induction of equal amounts of subjective respiratory distress , carbon dioxide inhalation was significantly more potent than increased airway resistance in provoking panic in the anxiety disorder patients . The patients with panic disorder were significantly more sensitive to CO2 than were the patients with social phobia or the normal subjects . CONCLUSIONS Carbon dioxide inhalation appears to have a specific panicogenic effect in panic patients that goes beyond simple breathlessness BACKGROUND Disordered breathing among patients with panic disorder , including hyperventilation during attacks and increased anxiogenic response to carbon dioxide ( CO2 ) inhalation , is well established . We wished to assess whether there is a change in the physiological response to CO2 after patients have undergone antipanic therapy with either tricyclic antidepressants or cognitive behavioral therapy ( CBT ) . METHODS Twenty-nine patients with panic disorder underwent baseline CO2 sensitivity testing using the traditional Read rebreathing method and then received either antidepressant treatment ( n = 21 ) or CBT ( n = 8) . After completing treatment , CO2 testing was repeated . A comparison sample of 14 normal volunteers also had two CO2 sensitivity tests , separated by an average of 21.6 ( SD = 8.8 ) weeks . RESULTS Using a liberal st and ard , in which all CO2 sensitivity tests whose correlations between minute ventilation and end-tidal CO2 were at least .75 were used , patients , but not controls , demonstrated a significant reduction in CO2 sensitivity between the first and second test . Using a more conservative .90 correlation st and ard reduced the sample size available and result ed in trend reduction in patients but no significant change in controls . There was a suggestion that the change was most pronounced in treatment responders , although the number of patient nonresponders is extremely small in this sample . CONCLUSIONS These data indicate that treatment reduces CO2 sensitivity in patients with panic disorder . We speculate that manipulation of the serotonergic and noradrenergic neurotransmission systems , both known to play a role in the control of respiration , may have a specific effect in reducing respiratory hyperactivity in panic disorder Panic disorder ( PD ) and asthma share many common characteristics and have been found in epidemiological studies to be significantly comorbid . To investigate possible reasons for this overlapping , the authors evaluated 51 patients with asthma , assessing the prevalence of PD and sporadic panic attacks , the temporal relationship between these two disorders , and the familial risk for PD in the families of asthmatics . The results showed significantly higher prevalences of PD , sporadic panic attacks , and social phobia in asthmatics than those reported for the general population . In 9 ( 90 % ) of the asthmatics with PD , asthma appeared first . Finally , the morbidity risk for PD in families of asthmatics with PD ( 13.5 % ) was significantly higher than in families of asthmatics without evidence of panic ( 2 % ) . Our results suggest that the high prevalence of PD in asthmatics might be related to a facilitating effect of asthma on the development of PD in subjects with familial pre
Output:
| RESULTS Lower pCO(2 ) levels in PD subjects are a consistent finding during the baseline/resting condition , the challenge , and recovery phases .
Tidal volume and minute volume are increased in PD subjects relative to controls during the baseline/resting condition .
However , the most robust finding is a higher than normal respiratory variability , which appears to be a promising factor for the identification of respiratory etiopathological pathways in PD .
Respiratory variability might be a c and i date for a biological marker of PD : an abnormal breathing pattern as found in panic disorder ( PD ) patients compared with controls might indicate instability of the respiratory homeostasis |
MS211855 | ***TASK*** the task is to summarize an input biomedical literature 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 Cigarette smoking is a tough addiction to break . Therefore , improved approaches to smoking cessation are necessary . The electronic-cigarette ( e-Cigarette ) , a battery-powered electronic nicotine delivery device ( ENDD ) resembling a cigarette , may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption . Efficacy and safety of these devices in long-term smoking cessation and /or smoking reduction studies have never been investigated . Methods In this prospect i ve proof-of-concept study we monitored possible modifications in smoking habits of 40 regular smokers ( unwilling to quit ) experimenting the ' Categoria ' e-Cigarette with a focus on smoking reduction and smoking abstinence . Study participants were invited to attend a total of five study visits : at baseline , week-4 , week-8 , week-12 and week-24 . Product use , number of cigarettes smoked , and exhaled carbon monoxide ( eCO ) levels were measured at each visit . Smoking reduction and abstinence rates were calculated . Adverse events and product preferences were also review ed . Results Sustained 50 % reduction in the number of cig/day at week-24 was shown in 13/40(32.5 % ) participants ; their median of 25 cigs/day decreasing to 6 cigs/day ( p < 0.001 ) . Sustained 80 % reduction was shown in 5/40(12.5 % ) participants ; their median of 30 cigs/day decreasing to 3 cigs/day ( p = 0.043 ) . Sustained smoking abstinence at week-24 was observed in 9/40(22.5 % ) participants , with 6/9 still using the e-Cigarette by the end of the study . Combined sustained 50 % reduction and smoking abstinence was shown in 22/40 ( 55 % ) participants , with an overall 88 % fall in cigs/day . Mouth ( 20.6 % ) and throat ( 32.4 % ) irritation , and dry cough ( 32.4 % ) were common , but diminished substantially by week-24 . Overall , 2 to 3 cartridges/day were used throughout the study . Participants ' perception and acceptance of the product was good . Conclusion The use of e-Cigarette substantially decreased cigarette consumption without causing significant side effects in smokers not intending to quit ( http:// Clinical Trials.gov number NCT01195597 ) Background While electronic cigarettes are forbidden in several countries , their sales are exploding in many others . Although e-cigarettes have been proposed as long-term substitutes for traditional smoking or as a tool for smoking cessation , very scarce data are available on their efficacy and safety . We describe the protocol of a 5-year multicentric prospect i ve study aim ed to evaluate short- and long-term adherence to e-cigarette smoking and the efficacy of e-cigarettes in reducing and /or quitting traditional cigarette smoking . The study will also compare the health effects of electronic vs traditional vs mixed cigarette smoking . Methods / design From June to December 2013 , we will enroll adult smokers of : ( EC ) e-cigarettes ( self-reported inhaling ≥ 50 puffs per week since ≥ 6 months ) ; ( TC ) traditional cigarettes ( ≥ 1 per day since ≥ 6 m ) ; ( Mixed ) both electronic and traditional cigarettes ( ≥1 per day since ≥ 6 m ) . Eligible subjects will be requested participation through newspaper advertisements and direct contact at the shops . Each subject will have to compile a structured question naire at enrolment and after 6 , 12 , 24 , 36 and 60 months . The level of carbon monoxide in expired after breath will be evaluated in all subjects declaring no traditional cigarette smoking in any follow-up phase , using portable carbon monoxide analyzers . The primary outcomes are traditional smoking cessation rates and number of smoked cigarettes . Secondary outcomes include adherence to e-cigarettes , self-reported adverse events , quality of life , and time to hospital admission for one among cardiovascular diseases , chronic obstructive pulmonary diseases , cancer of the lung , esophagus , larynx , oral cavity , bladder , pancreas , kidney , stomach , cervix , and myeloid leukemia . Admissions will be checked using official discharge data of the Abruzzo Region . A minimum of 500 subjects in each group will be enrolled , for a total of 1500 participants . Cox proportional hazards analysis will be used to calculate adjusted relative hazards of smoking cessation by each variable . Discussion Data on long-term efficacy and safety of e-cigarettes will be of utmost importance to form the basis for guidelines and regulatory decisions on e-cigarettes . Trial registration The protocol has been registered ( NCT01785537 ) and approved by the Ethics Committee of the University of Chieti ( Record n. 6 ; 25 - 03 - 2013 ) Background Electronic cigarettes ( e-cigarettes ) are becoming increasingly popular with smokers worldwide . Users report buying them to help quit smoking , to reduce cigarette consumption , to relieve tobacco withdrawal symptoms , and to continue having a ‘ smoking ’ experience , but with reduced health risks . Research on e-cigarettes is urgently needed in order to ensure that the decisions of regulators , healthcare providers and consumers are based on science . Methods ECLAT is a prospect i ve 12-month r and omized , controlled trial that evaluates smoking reduction/abstinence in 300 smokers not intending to quit experimenting two different nicotine strengths of a popular e-cigarette model ( ‘ Categoria ’ ; Arbi Group Srl , Italy ) compared to its non-nicotine choice . GroupA ( n = 100 ) received 7.2 mg nicotine cartridges for 12 weeks ; GroupB ( n = 100 ) , a 6-week 7.2 mg nicotine cartridges followed by a further 6-week 5.4 mg nicotine cartridges ; GroupC ( n = 100 ) received no-nicotine cartridges for 12 weeks . The study consisted of nine visits during which cig/day use and exhaled carbon monoxide ( eCO ) levels were measured . Smoking reduction and abstinence rates were calculated . Adverse events and product preferences were also review ed . Results Declines in cig/day use and eCO levels were observed at each study visits in all three study groups ( p<0.001 vs baseline ) , with no consistent differences among study groups . Smoking reduction was documented in 22.3 % and 10.3 % at week-12 and week-52 respectively . Complete abstinence from tobacco smoking was documented in 10.7 % and 8.7 % at week-12 and week-52 respectively . A substantial decrease in adverse events from baseline was observed and withdrawal symptoms were infrequently reported during the study . Participants ’ perception and acceptance of the product under investigation was satisfactory . Conclusion In smokers not intending to quit , the use of e-cigarettes , with or without nicotine , decreased cigarette consumption and elicited enduring tobacco abstinence without causing significant side effects . Trial Registration Clinical Trials.gov NCT01164072 Electronic cigarettes ( e-cigarettes ) are battery operated devices that deliver nicotine via inhaled vapour . Few studies have evaluated acute effects on craving and mood , and none have explored effects on cognition . This study aim ed to explore the effects of the White Super e-cigarette on desire to smoke , nicotine withdrawal symptoms , attention and working memory . Eighty-six smokers were r and omly allocated to either : 18 mg nicotine e-cigarette ( nicotine ) , 0 mg e-cigarette ( placebo ) , or just hold the e-cigarette ( just hold ) conditions . Participants rated their desire to smoke and withdrawal symptoms at baseline ( T1 ) , and five ( T2 ) and twenty ( T3 ) minutes after using the e-cigarette ad libitum for 5 min . A subset of participants completed the Letter Cancellation and Brown-Peterson Working Memory Tasks . After 20 min , compared with the just hold group , desire to smoke and some aspects of nicotine withdrawal were significantly reduced in the nicotine and placebo group ; the nicotine e-cigarette was superior to placebo in males but not in females . The nicotine e-cigarette also improved working memory performance compared with placebo at the longer interference intervals . There was no effect of nicotine on Letter Cancellation performance . To conclude , the White Super e-cigarette alleviated desire to smoke and withdrawal symptoms 20 min after use although the nicotine content was more important for males . This study also demonstrated for the first time that the nicotine e-cigarette can enhance working memory performance . Further evaluation of the cognitive effects of the e-cigarette and its efficacy as a cessation tool is merited Background : Cigarette smoking is a tough addiction to break . This dependence is the most common dual diagnosis for individuals with schizophrenia . Currently three effective drugs are approved for smoking cessation : nicotine replacement therapy ( NRT ) , varenicline and bupropion . However , some serious side effects of varenicline have been reported , including depression , suicidal thoughts , and suicide . The use of bupropion also has side effects . It should not be used by people who have epilepsy or any condition that lowers the seizure threshold , nor by people who take a specific class of drugs called monoamine oxidase inhibitors . Hence , there are pharmacodynamic reason to believe they could precipitate or exacerbate psychosis . For its capacity to deliver nicotine and provide a coping mechanism for conditioned smoking cues by replacing some of the rituals associated with smoking gestures , electronic-cigarettes may reduce nicotine withdrawal symptoms without serious side effects . Our recent work with ECs in healthy smokers not intending to quit consistently show surprisingly high success rates . We hypothesised that these positive findings could be replicated in difficult patients with schizophrenia This tool may help smokers with schizophrenia remain abstinent during their quitting attempts or to reduce cigarette consumption . Efficacy and safety of these devices in long-term smoking cessation and /or smoking reduction studies have never been investigated for this special population . Methods : In this study we monitored possible modifications in smoking habits of 14 smokers ( not intending to quit ) with schizophrenia experimenting with the “ Categoria ” e-Cigarette with a focus on smoking reduction and smoking abstinence . Study participants were invited to attend six study visits : at baseline , week-4 , week-8 , week-12 week-24 and week 52 . Product use , number of cigarettes smoked , carbon monoxide in exhaled breath ( eCO ) and positive and negative symptoms of schizophrenia levels were measured at each visit . Smoking reduction and abstinence rates were calculated . Adverse events were also review ed . Results : Sustained 50 % reduction in the number of cig/day at week-52 was shown in 7/14 ( 50 % ) participants ; their median of 30 cig/day decreasing significantly to 15 cig/day ( p = 0.018 ) . Sustained smoking abstinence at week-52 was observed in 2/14 ( 14.3 % ) participants . Combined sustained 50 % reduction and smoking abstinence was shown in 9/14 ( 64.3 % ) participants . Nausea was observed in 2/14 ( 14.4 % ) of participants , throat irritation in 2/14 ( 14.4 % ) of participants , headache in 2/14 ( 14.4 % ) of participants , and dry cough in 4/14 ( 28.6 % ) of participants . However , these adverse events diminished substantially by week-24 . Overall , one to two cartridges/day were used throughout the study . Positive and negative symptoms of schizophrenia are not increased after smoking reduction/cessation in patients using e-cigarettes . Conclusions : We have shown for the first time that the use of e-cigarette substantially decreased cigarette consumption without causing significant side effects in chronic schizophrenic patients who smoke not intending to quit . This was achieved without negative impacts on the symptoms of schizophrenia as assessed by SAPS and SANS symptoms scales AIMS To provide an initial abuse liability assessment of an electronic cigarette ( EC ) in current tobacco cigarette smokers . DESIGN The first of four within-subject sessions was an EC sampling session that involved six , 10-puff bouts ( 30 seconds inter-puff interval ) , each bout separated by 30 minutes . In the remaining three sessions participants made choices between 10 EC puffs and varying amounts of money , 10 EC puffs and a varying number of own br and cigarette ( OB ) puffs , or 10 OB puffs and varying amounts of money using the multiple-choice procedure ( MCP ) . The MCP was completed six times at 30-minute intervals , and one choice was reinforced r and omly at each trial . SETTING Clinical laboratory . PARTICIPANTS Twenty current tobacco cigarette smokers . MEASUREMENTS Sampling session outcome measures included plasma nicotine , cardiovascular response and subjective effects . Choice session outcome was the cross-over value on the MCP . FINDINGS EC use result ed in significant nicotine delivery , tobacco abstinence symptom suppression and increased product acceptability
Output:
| The use of the EC can reduce the number of cigarettes smoked and withdrawal symptoms , but the AEs reported are mainly related to a short period of use . |
MS211856 | ***TASK*** the task is to summarize an input biomedical literature 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 We report data from NEWART , a r and omised phase 4 clinical trial comparing virologic efficacy and safety of nevirapine ( NVP ) vs. ritonavir-boosted atazanavir ( ATV/r ) on a background of tenofovir/emtricitabine ( TDF/FTC ) in HIV-1-infected treatment-naïve patients . This study enrolled patients according to CD4-based initiation criteria for NVP ( < 250 cells/mm(3 ) for women and < 400 cells/mm(3 ) for men ) , to reduce the likelihood of symptomatic hepatic events . NEWART was design ed to support and confirm results from ARTEN , an international trial with similar design and study endpoints . METHODS A total of 152 patients were r and omised 1 : 1 to open-label NVP 200 mg twice daily or ATV/r ( 300/100 mg ) once daily , plus once daily TDF/FTC ( 300/200 mg ) . All participants met CD4(+ ) guidelines at entry . The primary endpoint for non-inferiority was virologic response prior to and at week 48 ( confirmed HIV plasma viral load < 50 copies/ml , without rebound or change in ARVs ) . Safety data , including plasma lipids , were recorded throughout the study . RESULTS The primary endpoint was achieved in 46/75 ( 61.3 % ) and 50/77 ( 64.9 % ) of patients taking NVP and ATV/r , respectively . Frequency of adverse events ( AEs ) was similar between arms , with 88.0 % of NVP-treated patients and 94.8 % of ATV/r-treated patients experiencing at least one AE . Nine patients ( 12 % ) in each arm experienced an AE that led to discontinuation . At week 48 , a significantly greater increase was seen in mean plasma HDL cholesterol ( HDL-C ) in the NVP arm ( 9.6 mg/dl ) vs. the ATV/r arm ( 3.5 mg/dl ) ; p = 0.016 . Also , total cholesterol (TC):HDL-C ratio on-treatment was -0.38 and -0.02 for the NVP and ATV/r arms , respectively ( p = 0.038 ) . CONCLUSIONS Efficacy results were consistent with the ARTEN study demonstrating that NVP was non-inferior to ATV/r when taken in combination with TDF/FTC . Rates of AEs were similar between the two arms , whereas HDL-C increased and TC : HDL-C decreased significantly more in patients taking NVP than ATV/r Introduction : Direct comparison of the efficacy and safety of different agents is needed to guide selection of optimal treatment regimens for therapy-naive HIV-1-infected patients . Methods : Gemini was a 48-week , multicenter , open-label , noninferiority trial in treatment-naive HIV-1-infected adults r and omized to either saquinavir/ritonavir ( SQV/r ) 1000 mg/100 mg twice a day or lopinavir/ritonavir ( LPV/r ) 400 mg/100 mg twice a day , each with emtricitabine/tenofovir 200 mg/300 mg every day . Results : A similar proportion of participants in the SQV/r ( n = 167 ) and LPV/r ( n = 170 ) arms had HIV-1 RNA levels < 50 copies per milliliter at week 48 : 64.7 % vs 63.5 % and estimated difference in proportion for noninferiority : 1.14 % , 96 % confidence interval : −9.6 to11.9 ( P < 0.012 ) , confirming that SQV/r was noninferior to LPV/r treatment . There were no significant differences in week 48 CD4 counts between arms . The rate and severity of adverse events were similar in both groups . There were no significant differences in the median change from baseline between arms in plasma lipids except for triglyceride levels , which were significantly higher in the LPV/r at week 48 . Conclusions : In treatment-naive , HIV-1-infected patients , SQV/r treatment was noninferior in virologic suppression at 48 weeks to LPV/r treatment and offered a better triglyceride profile In a r and omized control trial , Shahin Lockman and colleagues compare nevirapine-based therapy with lopinavir/ritonavir-based therapy for HIV-infected women without previous exposure to antiretroviral treatment Thomas Campbell and colleagues report findings of a r and omized trial conducted in multiple countries regarding the efficacy of antiretroviral regimens with simplified dosing OBJECTIVE To compare the efficacy and safety of fixed-dose abacavir/lamivudine ( ABC/3TC ) and tenofovir/emtricitabine ( TDF/FTC ) with ritonavir-boosted atazanavir ( ATV/r ) in treatment-naïve Japanese patients with HIV-1 infection . METHODS A 96-week multicenter , r and omized , open-label , parallel group pilot study was conducted . The endpoints were times to virologic failure , safety event and regimen modification . RESULTS 109 patients were enrolled and r and omly allocated ( 54 patients received ABC/3TC and 55 patients received TDF/FTC ) . All r and omized subjects were analyzed . The time to virologic failure was not significantly different between the two arms by 96 weeks ( HR , 2.09 ; 95 % CI , 0.72 - 6.13 ; p=0.178 ) . Both regimens showed favorable viral efficacy , as in the intention-to-treat population , 72.2 % ( ABC/3TC ) and 78.2 % ( TDF/FTC ) of the patients had an HIV-1 viral load < 50 copies/mL at 96 weeks . The time to the first grade 3 or 4 adverse event and the time to the first regimen modification were not significantly different between the two arms ( adverse event : HR 0.66 ; 95 % CI , 0.25 - 1.75 , p=0.407 ) ( regimen modification : HR 1.03 ; 95 % CI , 0.33 - 3.19 , p=0.964 ) . Both regimens were also well-tolerated , as only 11.1 % ( ABC/3TC ) and 10.9 % ( TDF/FTC ) of the patients discontinued the allocated regimen by 96 weeks . Clinical ly suspected abacavir-associated hypersensitivity reactions occurred in only one ( 1.9 % ) patient in the ABC/3TC arm . CONCLUSION Although insufficiently powered to show non-inferiority of viral efficacy of ABC/3TC relative to TDF/FTC , this pilot trial suggested that ABC/3TC with ATV/r is a safe and efficacious initial regimen for HLA-B*5701-negative patients , such as the Japanese population BACKGROUND Efavirenz with tenofovir-disoproxil-fumarate and emtricitabine is a preferred antiretroviral regimen for treatment-naive patients infected with HIV-1 . Rilpivirine , a new non-nucleoside reverse transcriptase inhibitor , has shown similar antiviral efficacy to efavirenz in a phase 2b trial with two nucleoside/nucleotide reverse transcriptase inhibitors . We aim ed to assess the efficacy , safety , and tolerability of rilpivirine versus efavirenz , each combined with tenofovir-disoproxil-fumarate and emtricitabine . METHODS We did a phase 3 , r and omised , double-blind , double-dummy , active-controlled trial , in patients infected with HIV-1 who were treatment-naive . The patients were aged 18 years or older with a plasma viral load at screening of 5000 copies per mL or greater , and viral sensitivity to all study drugs . Our trial was done at 112 sites across 21 countries . Patients were r and omly assigned by a computer-generated interactive web response system to receive either once-daily 25 mg rilpivirine or once-daily 600 mg efavirenz , each with tenofovir-disoproxil-fumarate and emtricitabine . Our primary objective was to show non-inferiority ( 12 % margin ) of rilpivirine to efavirenz in terms of the percentage of patients with confirmed response ( viral load < 50 copies per mL intention-to-treat time-to-loss-of-virological-response [ ITT-TLOVR ] algorithm ) at week 48 . Our primary analysis was by intention-to-treat . We also used logistic regression to adjust for baseline viral load . This trial is registered with Clinical Trials.gov , number NCT00540449 . FINDINGS 346 patients were r and omly assigned to receive rilpivirine and 344 to receive efavirenz and received at least one dose of study drug , with 287 ( 83 % ) and 285 ( 83 % ) in the respective groups having a confirmed response at week 48 . The point estimate from a logistic regression model for the percentage difference in response was -0.4 ( 95 % CI -5.9 to 5.2 ) , confirming non-inferiority with a 12 % margin ( primary endpoint ) . The incidence of virological failures was 13 % ( rilpivirine ) versus 6 % ( efavirenz ; 11%vs 4 % by ITT-TLOVR ) . Grade 2 - 4 adverse events ( 55 [ 16 % ] on rilpivirine vs 108 [ 31 % ] on efavirenz , p<0.0001 ) , discontinuations due to adverse events ( eight [ 2 % ] on rilpivirine vs 27 [ 8 % ] on efavirenz ) , rash , dizziness , and abnormal dreams or nightmares were more common with efavirenz . Increases in plasma lipids were significantly lower with rilpivirine . INTERPRETATION Rilpivirine showed non-inferior efficacy compared with efavirenz , with a higher virological-failure rate , but a more favourable safety and tolerability profile . FUNDING Tibotec BACKGROUND The aim of this study was to investigate the effect on fasting lipid parameters of switching to tenofovir disoproxil fumarate ( TDF ) plus emtricitabine ( FTC ) from abacavir ( ABC ) plus lamivudine ( 3TC ; both fixed-dose combinations ) , while maintaining ritonavir-boosted lopinavir ( LPV/r ) . METHODS This was an open-label r and omized two-arm 12-week controlled study in virologically suppressed HIV-infected patients with elevated cholesterol ( ≥5.2 mmol/l ) . Patients stable on ABC/3TC plus LPV/r either continued treatment or switched to TDF/FTC plus LPV/r for 12 weeks . St and ard efficacy and safety end points ( including fasting lipids ) were assessed . RESULTS In total , 85 subjects were treated ( n=42 ABC/FTC and n=43 TDF/3TC ) . A statistically significant decrease in total cholesterol was observed in the TDF/FTC group : from median ( IQR ) 6.22 mmol/l ( 5.91 - 6.77 ) at baseline to 5.75 mmol/l ( 5.04 - 6.18 ) at week 12 ( median [ IQR ] change from baseline -0.73 mmol/l [ -1.20- -0.18 ] ; P<0.001 ) . No notable change was observed for the ABC/3TC group . The difference between groups at week 12 was -0.82 mmol/l ( P<0.001 ) . For TDF/FTC ( but not for ABC/3TC ) , statistically significant reductions ( P<0.05 ) from baseline were observed in total , low-density lipoprotein , high-density lipoprotein (HDL)- and non-HDL cholesterol ( at weeks 4 and 12 ) . Statistically significant decreases were observed in median estimated creatinine clearance ( Cockcroft-Gault ) from baseline to week 12 for patients who switched to TDF/FTC ( -5.47 ml/min ) versus the ABC/3TC group ( -2.15 ml/min ; P=0.016 between groups ) . Virological suppression was maintained in both groups . No new safety issues were identified . CONCLUSIONS Switching to TDF/FTC from ABC/3TC was associated with rapid improvements in fasting lipid parameters and continued virological control in patients receiving LPV/r as the third component of antiretroviral therapy . The effect of these changes on clinical end points remains unclear and would need to be evaluated in a longer-term study Context Once-daily HIV treatment regimens are being used in clinical practice with the objective of improving patient acceptance and adherence . Objective To evaluate the efficacy and safety of saquinavir-soft-gelatin capsule (SGC)/ritonavir combination ( 1600 mg/100 mg ) vs efavirenz ( 600 mg ) both once daily and combined with 2 nucleoside analogs twice daily . Setting Tw
Output:
| Adjusting for the effect of NRTI backbone , treatment with DTG result ed in significantly higher odds of virologic suppression ( HIV RNA<50 copies/mL ) and increase in CD4 + cells/µL versus ATV/r , DRV/r , EFV , LPV/r , and RPV .
Dolutegravir had better or equivalent changes in total cholesterol , LDL , triglycerides , and lower odds of adverse events and discontinuation due to adverse events compared to all treatments .
Conclusion Three clinical trials of DTG have demonstrated comparable or superior efficacy and safety to DRV , RAL , and EFV in HIV-1–infected treatment-naive patients .
This network meta- analysis suggests DTG is also favorable or comparable to other commonly used third agents ( ATV/r , LPV/r , RPV , and EVG/c ) |
MS211857 | ***TASK*** the task is to summarize an input biomedical literature 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 Evidence suggests an association between periodontal disease and coronary heart disease ( CHD ) . C-reactive protein ( CRP ) , fibrinogen , and white blood cell ( WBC ) counts are markers of inflammation , and their systemic levels have been associated with CHD risk . This pilot study investigated the effect of non-surgical periodontal therapy on systemic levels of CRP , fibrinogen , and WBC counts in subjects with CHD or no CHD ( NCHD ) . METHODS Twenty-seven angiographically defined patients with CHD and 18 subjects with NCHD aged > or=40 years were recruited for the study . Periodontal disease was measured through the clinical parameters bleeding on probing ( BOP ) and probing depth ( PD ) . All subjects received non-surgical periodontal therapy that included oral hygiene instructions and subgingival scaling and root planing . Systemic levels of inflammatory markers ( CRP , fibrinogen , and WBC counts ) were measured prior to and 1 month after periodontal therapy . RESULTS Seventeen subjects with CHD and 11 subjects with NCHD completed the study . Subjects with CHD or NCHD experienced significant reductions in BOP ( 59 % and 34 % , respectively ; P < 0.05 ) and PD ( 41 % and 35 % , respectively ; P < 0.05 ) , with non-significant intergroup differences ( P > 0.05 ) . In all subjects , CRP , fibrinogen , and WBC counts were reduced significantly ( 21 % to 40 % ) after periodontal therapy ( P < 0.05 ) . CONCLUSIONS Periodontal treatment result ed in significant decreases in BOP and PD and lowered serum inflammatory markers in patients with CHD or NCHD . This may result in a decreased risk for CHD in the treated patients . These findings will allow pursuit of a large-scale r and omized intervention trial in this population BACKGROUND Chronic infections , such as periodontitis , are associated with increased risk of systemic diseases driven by a persistent low- grade systemic inflammation and metabolic changes . Severity of periodontitis has also been associated with increased systolic blood pressure ( BP ) . However , the issue remains poorly investigated . We aim ed to estimate the effect of periodontal therapy on traditional and novel cardiovascular risk factors in systemically healthy individuals who have periodontitis . METHODS We enrolled 40 otherwise healthy patients with severe chronic generalized periodontitis in a 6-month pilot intervention trial . Individuals were r and omized either to a st and ard course of periodontal therapy ( subgingival scaling and root planing ) or an intensive one ( including the adjunctive use of a locally delivered antimicrobial , IPT ) . RESULTS Compared to control , IPT produced significant reductions in a cluster of inflammatory markers at 1 ( P = .0406 ) and 2 ( P = .0060 ) months together with an improvement in lipid markers at 2 ( P = .0320 ) and 6 ( P = .0432 ) months after therapy . Intensive periodontal therapy produced greater reductions in IL-6 at 1 ( 0.4 + /- 0.2 ng/L difference , 95 % CI 0.03 - 0.9 , P = .0284 ) and 2 months ( 0.3 + /- 0.2 ng/L difference , 95 % CI 0.1 - 0.8 , P = .0284 ) , together with decreases in C-reactive protein ( 0.4 + /- 0.2 mg/L difference , 95 % CI 0.01 - 0.8 , P = .0438 ) and total cholesterol ( 0.3 + /- 0.1 mmol/L difference , 95 % CI 0.04 - 0.6 , P = .0254 ) . Moreover , a 7 + /- 3-mm Hg decrease in systolic BP was observed at 2 months in the IPT group ( 95 % CI 1 - 12 , P = .0211 ) , and this difference was greater in current smokers ( 14 + /- 5 mm Hg 95 % CI 3 - 25 , P = 0.0124 ) . Intensive periodontal therapy subjects exhibited a 1.53 % + /- 1.20 % ( 95 % CI 1.05 - 2.24 , P = .0290 ) and 2.00 % + /- 1.42 % ( 95 % CI 0.98 - 4.09 , P = .0568 ) decreases in cardiovascular risk scores ( Framingham ) at 2 and 6 months , respectively , when compared to those in the st and ard group . CONCLUSIONS Our findings suggest that intensive periodontal treatment reduces systemic inflammatory markers and systolic BP , and improves lipid profiles with subsequent changes in cardiovascular risk when compared to st and ard therapy BACKGROUND Systemic inflammation may impair vascular function , and epidemiologic data suggest a possible link between periodontitis and cardiovascular disease . METHODS We r and omly assigned 120 patients with severe periodontitis to community-based periodontal care ( 59 patients ) or intensive periodontal treatment ( 61 ) . Endothelial function , as assessed by measurement of the diameter of the brachial artery during flow ( flow-mediated dilatation ) , and inflammatory biomarkers and markers of coagulation and endothelial activation were evaluated before treatment and 1 , 7 , 30 , 60 , and 180 days after treatment . RESULTS Twenty-four hours after treatment , flow-mediated dilatation was significantly lower in the intensive-treatment group than in the control-treatment group ( absolute difference , 1.4 % ; 95 % confidence interval [ CI ] , 0.5 to 2.3 ; P=0.002 ) , and levels of C-reactive protein , interleukin-6 , and the endothelial-activation markers soluble E-selectin and von Willebr and factor were significantly higher ( P<0.05 for all comparisons ) . However , flow-mediated dilatation was greater and the plasma levels of soluble E-selectin were lower in the intensive-treatment group than in the control-treatment group 60 days after therapy ( absolute difference in flow-mediated dilatation , 0.9 % ; 95 % CI , 0.1 to 1.7 ; P=0.02 ) and 180 days after therapy ( difference , 2.0 % ; 95 % CI , 1.2 to 2.8 ; P<0.001 ) . The degree of improvement was associated with improvement in measures of periodontal disease ( r=0.29 by Spearman rank correlation , P=0.003 ) . There were no serious adverse effects in either of the two groups , and no cardiovascular events occurred . CONCLUSIONS Intensive periodontal treatment result ed in acute , short-term systemic inflammation and endothelial dysfunction . However , 6 months after therapy , the benefits in oral health were associated with improvement in endothelial function 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 BACKGROUND Studies investigating effects of periodontal treatment ( PT ) on markers of inflammation in healthy subjects show conflicting results . Few studies have investigated the effects of PT among subjects with coronary heart disease ( CHD ) risk factors . AIM To report the results of a pilot prospect i ve study on the effects of periodontal treatment on markers of inflammation among subjects with CHD risk factors . MATERIAL AND METHODS Seventy three patients aged 53+/-6 years ( 25 % males ) with chronic periodontitis , dyslipidemia and other CHD risk factors were subjected to PT consisting on root planning and oral metronidazol and amoxicillin for 7 days . Periodontal clinical parameters , serum C-reactive protein ( CRP ) , fibrinogen levels and erythrocyte sedimentation rate ( ESR ) were assessed before and at 6 weeks after PT . Polymorphisms at the ILlA-889 and IL1B+3954 genes were also genotyped . RESULTS After the treatment period , CRP levels significantly increased from 3.6+/-3.7 mg/ L to 5.4+/-5.7 mg/L ( p = 0.001 ) . No significant changes were observed in fibrinogen levels and ESR . Higher post-treatment CRP levels were significantly associated with the composite polymorphic genotype at the ILlA-889 and IL1B+3954 genes ( p = 0.0001 ) , and extensive periodontitis ( p = 0.005 ) . Moderate alcohol consumption appeared as a protective factor for CRP elevation ( p = 0.029 ) . CONCLUSIONS The increase of the CRP levels after PT in patients with CVD risk factors appeared associated with IL-1 gene polymorphisms and extensive periodontitis Most studies linking obesity and periodontal disease have been cross-sectional in design . We examined whether gains in body weight , waist circumference , and arm fat area are associated with periodontitis progression in 893 non-diabetic men followed for up to four decades in the prospect i ve VA Dental Longitudinal Study . Probing pocket depth ( PPD ) was measured by calibrated examiners . Repeated- measures generalized linear models estimated the mean cumulative numbers of teeth with PPD events ( PPD > 3 mm ) at each dental examination and the slopes associated with increasing numbers of affected teeth over time . Means were adjusted for baseline PPD , education , and cigarette pack-years , and time-dependent values of age , mean plaque score , cigarette packs/day , brushing , and flossing . Men who were overweight at baseline and gained weight most rapidly ( > 0.19 kg/yr or ~15 lb during follow-up ) had significantly more PPD events than men in the lowest tertile of weight gain ( ≤ -0.05 kg/yr ) . Overweight men whose waist circumference increased > 0.14–0.39 or > 0.39 cm/yr experienced more PPD events than men in the lowest tertile ( ≤ 0.14 cm/yr ) . Increase in arm fat area was associated with disease progression in normal-weight men . These results suggest that tracking adiposity changes with easily obtained anthropometric measures may help predict risk of periodontitis progression BACKGROUND We investigated the effect of oral alendronate ( ALN ) treatment on radiological and clinical measurements of periodontal disease in postmenopausal women without hormone replacement therapy . METHODS We evaluated the effect of 6 months of ALN treatment in 40 postmenopausal women , 55 to 65 years old with established periodontal disease , in a controlled , double-masked , prospect i ve study . Volunteers were paired by age and r and omized to receive ALN ( 10 mg/day ) or placebo for the study period . Periodontal mechanical treatment was carried out in both groups . At baseline and after treatment , clinical evaluation , hormone blood levels , distance from the crestal alveolar bone ( CAB ) to the cemento-enamel junction ( CEJ ) , calcaneus bone mineral density ( BMD ) , hormone levels , serum N-telopeptide ( NTx ) , and bone-specific alkaline phosphatase ( BSAP ) were assessed . RESULTS Periodontal disease conditions improved in both groups , but greater improvement in probing depth ( -0.8 + /- 0.3 mm versus -0.4 + /- 0.4 mm , P = 0.02 ) and gingival
Output:
| Whereas no difference was found in clinical periodontal parameters , significant differences in inflammatory or metabolic parameters were found between overweight/obese and normal-weight patients , but existing evidence is weak |
MS211858 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE The purpose of this study was to estimate the prevalence and time trends in prescriptions of methylpheni date , dexamphetamine , and atomoxetine in children and adolescents , within three diagnostic groups : 1 ) autism spectrum disorder ( ASD ) , 2 ) attention-deficit/hyperactivity disorder ( ADHD ) , and 3 ) other psychiatric disorders . METHODS Data from six different national registers were used and merged to identify a cohort of all children and adolescents born in Denmark between 1990 and 2001 ( n=852,711 ) . Sociodemographic covariates on cohort members and their parents and lifetime prescriptions of methylpheni date , dexamphetamine , and atomoxetine were extracted from the registers . Prescriptions were also stratified by duration ( < 6 months . vs.≥ 6 months ) . RESULTS Sixteen percent of 9698 children and adolescents with ASD ( n=1577 ) , 61 % of 11,553 children and adolescents with ADHD ( n=7021 ) and 3 % of 48,468 children and adolescents with other psychiatric disorders ( n=1537 ) were treated with one or more ADHD medications . There was a significant increase in prescription rates of these medications for all three groups . From 2003 to 2010 , youth 6 - 13 years of age with ASD , ADHD , and other psychiatric disorders had 4.7-fold ( 4.4 - 4.9 ) , 6.3-fold ( 6.0 - 6.4 ) , and 5.5-fold ( 5.0 - 5.9 ) increases , respectively , in prescription rates of ADHD medications . CONCLUSION This is the largest study to date assessing stimulant treatment in children and adolescents with ASD , and is the first prospect i ve study quantifying the change over time in the prevalence of treatment with ADHD medications in a population -based national cohort of children and adolescents with ASD . The prevalence of stimulant treatment in youth with ASD of 16 % is consistent with earlier studies . The past decade has witnessed a clear and progressive increase in the prescription rates of medications typically used to treat ADHD in children and adolescents in Denmark . This increase is not limited to only those with ADHD , but includes others with neuropsychiatric disorders , including ASD . The risks and benefits of this practice await further study OBJECTIVE . The objective of this study was to provide national estimates of psychotropic medication use among Medicaid-enrolled children with autism spectrum disorders and to examine child and health system characteristics associated with psychotropic medication use . METHODS . This cross-sectional study used Medicaid cl aims for calendar year 2001 from all 50 states and Washington , DC , to examine 60641 children with an autism spectrum disorder diagnosis . Logistic regression with r and om effects was used to examine the child , county , and state factors associated with psychotropic medication use . RESULTS . Of the sample , 56 % used at least 1 psychotropic medication , 20 % of whom were prescribed ≥3 medications concurrently . Use was common even in children aged 0 to 2 years ( 18 % ) and 3 to 5 years ( 32 % ) . Neuroleptic drugs were the most common psychotropic class ( 31 % ) , followed by antidepressants ( 25 % ) and stimulants ( 22 % ) . In adjusted analyses , male , older , and white children ; those who were in foster care or in the Medicaid disability category ; those who received additional psychiatric diagnoses ; and those who used more autism spectrum disorder services were more likely to have used psychotropic drugs . Children who had a diagnosis of autistic disorder or who lived in counties with a lower percentage of white residents or greater urban density were less likely to use such medications . CONCLUSIONS . Psychotropic medication use is common among even very young children with autism spectrum disorders . Factors unrelated to clinical presentation seem highly associated with prescribing practice s. Given the limited evidence base , there is an urgent need to assess the risks , benefits , and costs of medication use and underst and the local and national policies that affect medication use This study examined change prospect ively in autism symptoms and maladaptive behaviors during a 4.5 year period in 241 adolescents and adults with an autism spectrum disorder who were 10–52 years old ( mean = 22.0 ) when the study began . Although many individuals ’ symptoms remained stable , a greater proportion of the sample experienced declines than increases in their level of autism symptoms and maladaptive behaviors , and there were significant improvements in mean levels of symptoms . Individuals with mental retardation had more autism symptoms and maladaptive behaviors than those without mental retardation , and they improved less over time . Compared to adolescents , older sample members ( 31 and older ) had fewer maladaptive behaviors and experienced more improvement in these behaviors over time OBJECTIVE . Data on the current costs of medical services for children with autism spectrum disorders are lacking . Our purpose for this study was to compare health care utilization and costs of children with and without autism spectrum disorders in the same health plan . PATIENTS AND METHODS . Participants included all 2- to 18-year-old children with autism spectrum disorders ( n = 3053 ) and a r and om sample of children without autism spectrum disorders ( n = 30529 ) who were continuously enrolled in the Kaiser Permanente Medical Care Program in northern California between July 1 , 2003 , and June 30 , 2004 . Data on health care utilization and costs were derived from health plan administrative data bases . MAIN OUTCOME MEASURES . Outcome measures included mean annual utilization and costs of health services per child . RESULTS . Children with autism spectrum disorders had a higher annual mean number of total clinic ( 5.6 vs 2.8 ) , pediatric ( 2.3 vs 1.6 ) , and psychiatric ( 2.2 vs 0.3 ) outpatient visits . A higher percentage of children with autism spectrum disorders experienced inpatient ( 3 % vs 1 % ) and outpatient ( 5 % vs 2 % ) hospitalizations . Children with autism spectrum disorders were nearly 9 times more likely to use psychotherapeutic medications and twice as likely to use gastrointestinal agents than children without autism spectrum disorders . Mean annual member costs for hospitalizations ( $ 550 vs $ 208 ) , clinic visits ( $ 1373 vs $ 540 ) , and prescription medications ( $ 724 vs $ 96 ) were more than double for children with autism spectrum disorders compared with children without autism spectrum disorders . The mean annual age- and gender-adjusted total cost per member was more than threefold higher for children with autism spectrum disorders ( $ 2757 vs $ 892 ) . Among the subgroup of children with other psychiatric conditions , total mean annual costs were 45 % higher for children with autism spectrum disorders compared with children without autism spectrum disorders ; excess costs were largely explained by the increased use of psychotherapeutic medications . CONCLUSIONS . The utilization and costs of health care are substantially higher for children with autism spectrum disorders compared with children without autism spectrum disorders . Research is needed to evaluate the impact of improvements in the management of children with autism spectrum disorders on health care utilization and costs Introduction : Antipsychotic polypharmacy ( APP ) , the concomitant use of ≥ 2 antipsychotics , is common in clinical practice . Prior review s have focused on the efficacy of APP , but no systematic review exists regarding the safety and tolerability of this practice . Areas covered : A systematic review of adverse effects associated with APP was conducted to prepare this review ; case series with ≥ 2 patients , chart review s , naturalistic , data base , cohort and r and omized studies that reported on the association between APP in general or specific APP combinations and global or specific adverse effect were included . Method ological limitations of available studies are discussed and recommendations for clinicians and future research are provided . Expert opinion : Across mostly small and uncontrolled studies , APP has been associated with increased global side effect burden , rates of Parkinsonian side effects , anticholinergic use , hyperprolactinemia , sexual dysfunction , hypersalivation , sedation/somnolence , cognitive impairment and diabetes . Effects on akathisia and mortality were inconclusive . Although some combinations , particularly aripiprazole augmentation of an agent with greater side effect burden , may reduce weight gain , dyslipidemia , hyperprolactinemia and sexual dysfunction , APP should remain a last-resort treatment option after monotherapy , switching and non-antipsychotic combinations have failed . More data are needed to further inform the individualized risk – benefit evaluation of APP
Output:
| Regarding drug classes , antipsychotics were most frequently used , followed by attention-deficit/hyperactivity disorder ( ADHD ) medication and antidepressants .
Both older age and psychiatric comorbidity were associated with higher prevalences of psychopharmacotherapy and psychotropic polypharmacy .
There were no time trends in psychopharmacotherapy prevalence observable .
Despite a lack of pharmacological treatment options for ASD core symptoms , the prevalence of psychopharmacotherapy and polypharmacy in ASD patients is considerable , which is probably due to the treatment of non-core ASD symptoms and psychiatric comorbidities . |
MS211859 | ***TASK*** the task is to summarize an input biomedical literature 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 There is growing evidence concerning the acceptability and feasibility of home-based HIV testing . However , less is known about the cost-effectiveness of the approach yet it is a critical component to guide decisions about scaling up access to HIV testing . This study examined the cost-effectiveness of a home-based HIV testing intervention in rural South Africa . Methods Two alternatives : clinic and home-based HIV counselling and testing were compared . Costs were analysed from a provider ’s perspective for the period of January to December 2010 . The outcome , HIV counselling and testing ( HCT ) uptake was obtained from the Good Start home-based HIV counselling and testing ( HBHCT ) cluster r and omised control trial undertaken in KwaZulu-Natal province . Cost-effectiveness was estimated for a target population of 22,099 versus 23,864 people for intervention and control communities respectively . Average costs were calculated as the cost per client tested , while cost-effectiveness was calculated as the cost per additional client tested through HBHCT . Results Based on effectiveness of 37 % in the intervention ( HBHCT ) arm compared to 16 % in control arm , home based testing costs US$ 29 compared to US$ 38 per person for clinic HCT . The incremental cost effectiveness per client tested using HBHCT was $ 19 . Conclusions HBHCT was less costly and more effective . Home-based HCT could present a cost-effective alternative for rural ‘ hard to reach ’ population s depending on affordability by the health system , and should be considered as part of community outreach programs Introduction Linkage from HIV testing and counselling ( HTC ) to initiation of antiretroviral therapy ( ART ) is suboptimal in many national programmes in sub-Saharan Africa , leading to delayed initiation of ART and increased risk of death . Reasons for failure of linkage are poorly understood . Methods Semi-structured qualitative interviews were undertaken with health providers and HIV-positive primary care patients as part of a prospect i ve cohort study at primary health centres in Blantyre , Malawi . Patients successful and unsuccessful in linking to ART were included . Results Progression through the HIV care pathway was strongly influenced by socio-cultural norms , particularly around the perceived need to regain respect lost during a period of visibly declining health . Capacity to call upon the support of networks of families , friends and employers was a key determinant of successful progression . Over-busy clinics , non-functioning laboratories and unsuitable tools used for ART eligibility assessment ( WHO clinical staging system and central ized CD4 count measurement ) were important health systems determinants of drop-out . Conclusions Key interventions that could rapidly improve linkage include guarantee of same-day , same-clinic ART eligibility assessment s ; utilization of the support offered by peer-groups and community health workers ; and integration of HTC and ART programmes Background Antiretroviral therapy ( ART ) has been scaled-up rapidly in Africa . Programme reports typically focus on loss to follow-up and mortality among patients receiving ART . However , little is known about linkage and retention in care of individuals prior to starting ART . Methodology Data on adult residents from a periurban community in Cape Town were collected at a primary care clinic and hospital . HIV testing registers , CD4 count results provided by the National Health Laboratory System and ART registers were linked . A r and om sample ( n = 885 ) was drawn from adults testing HIV positive through antenatal care , sexual transmitted disease and voluntary testing and counseling services between January 2004 and March 2009 . All adults ( n = 103 ) testing HIV positive through TB services during the same time period were also included in the study . Linkage to HIV care was defined as attending for a CD4 count measurement within 6 months of HIV diagnosis . Linkage to ART care was defined as initiating ART within 6 months of HIV diagnosis in individuals with a CD4 count ≤200 cells/µl taken within 6 months of HIV diagnosis . Findings Only 62.6 % of individuals attended for a CD4 count measurement within 6 months of testing HIV positive . Individuals testing through sexually transmitted infection services had the best ( 84.1 % ) and individuals testing on their own initiative ( 53.5 % ) the worst linkage to HIV care . One third of individuals with timely CD4 counts were eligible for ART and 66.7 % of those were successfully linked to ART care . Linkage to ART care was highest among antenatal care clients . Among individuals not yet eligible for ART only 46.3 % had a repeat CD4 count . Linkage to HIV care improved in patients tested in more recent calendar period . Conclusion Linkage to HIV and ART care was low in this poor peri-urban community despite free services available within close proximity . More efforts are needed to link VCT scale-up to subsequent care Background The 2015 WHO recommendation of antiretroviral therapy ( ART ) for all immediately following HIV diagnosis is partially based on the anticipated impact on HIV incidence in the surrounding population . We investigated this approach in a cluster-r and omised trial in a high HIV prevalence setting in rural KwaZulu-Natal . We present findings from the first phase of the trial and report on uptake of home-based HIV testing , linkage to care , uptake of ART , and community attitudes about ART . Methods and Findings Between 9 March 2012 and 22 May 2014 , five clusters in the intervention arm ( immediate ART offered to all HIV-positive adults ) and five clusters in the control arm ( ART offered according to national guidelines , i.e. , CD4 count ≤ 350 cells/μl ) contributed to the first phase of the trial . Households were visited every 6 mo . Following informed consent and administration of a study question naire , each resident adult ( ≥16 y ) was asked for a finger-prick blood sample , which was used to estimate HIV prevalence , and offered a rapid HIV test using a serial HIV testing algorithm . All HIV-positive adults were referred to the trial clinic in their cluster . Those not linked to care 3 mo after identification were contacted by a linkage-to-care team . Study procedures were not blinded . In all , 12,894 adults were registered as eligible for participation ( 5,790 in intervention arm ; 7,104 in control arm ) , of whom 9,927 ( 77.0 % ) were contacted at least once during household visits . HIV status was ever ascertained for a total of 8,233/9,927 ( 82.9 % ) , including 2,569 ascertained as HIV-positive ( 942 tested HIV-positive and 1,627 reported a known HIV-positive status ) . Of the 1,177 HIV-positive individuals not previously in care and followed for at least 6 mo in the trial , 559 ( 47.5 % ) visited their cluster trial clinic within 6 mo . In the intervention arm , 89 % ( 194/218 ) initiated ART within 3 mo of their first clinic visit . In the control arm , 42.3 % ( 83/196 ) had a CD4 count ≤ 350 cells/μl at first visit , of whom 92.8 % initiated ART within 3 mo . Regarding attitudes about ART , 93 % ( 8,802/9,460 ) of participants agreed with the statement that they would want to start ART as soon as possible if HIV-positive . Estimated baseline HIV prevalence was 30.5 % ( 2,028/6,656 ) ( 95 % CI 25.0 % , 37.0 % ) . HIV prevalence , uptake of home-based HIV testing , linkage to care within 6 mo , and initiation of ART within 3 mo in those with CD4 count ≤ 350 cells/μl did not differ significantly between the intervention and control clusters . Selection bias related to noncontact could not be entirely excluded . Conclusions Home-based HIV testing was well received in this rural population , although men were less easily contactable at home ; immediate ART was acceptable , with good viral suppression and retention . However , only about half of HIV-positive people accessed care within 6 mo of being identified , with nearly two-thirds accessing care by 12 mo . The observed delay in linkage to care would limit the individual and public health ART benefits of universal testing and treatment in this population . Trial registration Clinical Trials.gov Introduction We aim ed to quantify and identify associated factors of linkage to HIV care following home-based HIV counselling and testing ( HBHCT ) in the ongoing ANRS 12249 treatment-as-prevention ( TasP ) cluster-r and omized trial in rural KwaZulu-Natal , South Africa . Methods Individuals ≥16 years were offered HBHCT ; those who were identified HIV positive were referred to cluster-based TasP clinics and offered antiretroviral treatment ( ART ) immediately ( five clusters ) or according to national guidelines ( five clusters ) . HIV care was also available in the local Department of Health ( DoH ) clinics . Linkage to HIV care was defined as TasP or DoH clinic attendance within three months of referral among adults not in HIV care at referral . Associated factors were identified using multivariable logistic regression adjusted for trial arm . Results Overall , 1323 HIV-positive adults ( 72.9 % women ) not in HIV care at referral were included , of whom 36.9 % ( n=488 ) linked to care <3 months of referral ( similar by sex ) . In adjusted analyses ( n=1222 ) , individuals who had never been in HIV care before referral were significantly less likely to link to care than those who had previously been in care ( <33 % vs. > 42 % , p<0.001 ) . Linkage to care was lower in students ( adjusted odds-ratio [aOR]=0.47 ; 95 % confidence interval [ CI ] 0.24–0.92 ) than in employed adults , in adults who completed secondary school ( aOR=0.68 ; CI 0.49–0.96 ) or at least some secondary school ( aOR=0.59 ; CI 0.41–0.84 ) versus ≤ primary school , in those who lived at 1 to 2 km ( aOR=0.58 ; CI 0.44–0.78 ) or 2–5 km from the nearest TasP clinic ( aOR=0.57 ; CI 0.41–0.77 ) versus < 1 km , and in those who were referred to clinic after ≥2 contacts ( aOR=0.75 ; CI 0.58–0.97 ) versus those referred at the first contact . Linkage to care was higher in adults who reported knowing an HIV-positive family member ( aOR=1.45 ; CI 1.12–1.86 ) versus not , and in those who said that they would take ART as soon as possible if they were diagnosed HIV positive ( aOR=2.16 ; CI 1.13–4.10 ) versus not . Conclusions Fewer than 40 % of HIV-positive adults not in care at referral were linked to HIV care within three months of HBHCT in the TasP trial . Achieving universal test and treat coverage will require innovative interventions to support linkage to HIV care Background In high HIV prevalence setting s , offering HIV testing may be a reasonable part of contact tracing of index tuberculosis ( TB ) patients . We evaluated the uptake of HIV counselling and testing ( HCT ) among household contacts of index TB patients and the proportion of newly diagnosed HIV-infected persons linked into care as part of a household TB contact tracing study . Methods We recruited index TB patients at public health clinics in two South African provinces to obtain consent for household contact tracing . During scheduled household visits we offered TB symptom screening to all household members and HCT to individuals ≥14years of age . Factors associated with HCT uptake were investigated using a r and om effects logistic regression model . Results & Discussion Out of 1,887 listed household members ≥14 years old , 984 ( 52 % ) were available during a household visit and offered HCT of which 108 ( 11 % ) self-reported being HIV infected and did not undergo HCT . Of the remaining 876 , a total of 304 agreed to HCT ( 35 % ) ; 26 ( 8.6 % ) were newly diagnosed as HIV positive . In multivariable analysis , factors associated with uptake of HCT were prior testing ( odds ratio 1.6 ; 95 % confidence interval [ CI ] : 1.1–2.3 ) and another member in the household testing ( odds ratio 2.4 ; 95 % CI : 1.7–3.4 ) . Within 3 months of testing HIV-positive , 35 % reported initiating HIV care . Conclusion HCT as a component of household TB contact tracing reached individuals without prior HIV testing , however uptake of HIV testing was poor . Strategies to improve HIV testing in household contacts should be evaluated OBJECTIVE Antiretroviral therapy ( ART ) significantly decreases HIV-associated morbidity , mortality , and HIV transmission through HIV viral load suppression . In high HIV prevalence setting s , outreach strategies are needed to find asymptomatic HIV positive persons , link them to HIV care and ART , and achieve viral suppression . METHODS We conducted a prospect i ve intervention study in two rural communities in KwaZulu-Natal , South Africa , and Mbabara district , Ug and a. The intervention included home HIV testing and counseling ( HTC ) , point-of-care CD4 count testing for HIV positive persons , referral to care , and one month then quarterly lay counselor follow-up visits . The outcomes at 12 months were linkage to care , and ART initiation and viral suppression among
Output:
| Linkage was often low after routine referral but higher if additional interventions were used to facilitate it . |
MS211860 | ***TASK*** the task is to summarize an input biomedical literature 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 see whether fourth-year medical students can teach the physical examination to first-year students as effectively as can faculty preceptors . METHOD : Ninety-three first-year students study ing the physical examination were r and omly assigned to one of ten fourth-year student preceptors or one of 15 faculty preceptors . Test results and course evaluations were compared by type of preceptor . Fourth-year student preceptors were surveyed regarding their experience . RESULTS : The mean test scores did not differ between the first-year students with fourth-year student preceptors and those with faculty preceptors . The first-year students rated the fourth-year student preceptors higher than they did the faculty preceptors . The fourth-year students rated their experience favorably . CONCLUSION : A select group of fourth-year medical students provides a successful alternative to faculty in the teaching of the physical examination to first-year students Aim : The aim of this study is to compare student teachers and clinical associate professors regarding the quality of procedural skills teaching in terms of participants ’ technical skills , knowledge and satisfaction with the teaching . Methods : This is an experimental , r and omized , controlled study comparing the teaching of student teachers and associate professors regarding participants ’ learning outcome and satisfaction with the teaching . Two skills are chosen for the experiment , IV-access and bladder catheterization . Learning outcome is assessed by a pre- and post testing of the participants ’ knowledge and skills . Participants evaluate satisfaction with teaching on nine statements immediately after the teaching . Results : In total 59 first year medical students are included as participants in the experiment . The students taught by student teachers perform just as well as the students taught by associate professors and in one skill – catheterization – they perform even better , mean post- minus pre-test scores 65.5 ( SD 12.9 ) vs. 35.0 ( SD 23.3 ) , One-way ANOVA , p < 0.0001 , effect size 1.62 . Student teachers receive significantly more positive evaluations than associate professors on several statements . Conclusion : Trained student teachers can be as good as associate professors in teaching clinical skills Peer tutoring is a potentially valuable re source in higher education . There are few published accounts of the impact of peer tutoring in medical education . College-wide experience of peer tutoring together with difficulties recruiting medical teachers for a communication programme led to the development of a peer-tutoring project . This paper reports the impact on first-year medical students of peer tutoring in patient-centred interviewing . After attending a preparatory workshop , third-year medical students co-facilitated their first-year colleagues in a session : Interviewing a Simulated Patient . First-year students completed written evaluations immediately after the session and two months later r and omly selected students were assessed in patient-centred interviews . The impact of the peer-tutoring experience was evaluated by comparing these outcomes for students in groups co-facilitated by peer tutors with those who worked in groups facilitated by medical teachers . The eight learning objectives were completely met by more than 56 % of students . However , there were statistically significant differences for four objectives with more students in groups facilitated by medical teachers completely meeting these objectives . Although the seven educational techniques used in the session were rated favourably by all students , two were rated as more effective in achieving the learning objectives by students in groups facilitated by medical teachers . Free-text comments revealed no differences between groups . Two months after the session , there were no differences between students in terms of interviewing skills as rated by trained observers and simulated patients , whilst simulated patients were more satisfied with interviews from students facilitated by peer tutors ( p < 0.02 ) . Peer tutors can support the acquisition of basic patient-centred interviewing skills in first-year medical students when contributing to one session of a structured programme . First-year students were receptive and willing to learn from their senior colleagues Abstract . Limited access to expert tutors is a problem that can be addressed by using tutors from different stages of medical or non-medical ( under- , post- ) graduate education . To address whether such differences in qualification affect the results of process evaluation by participants or their learning outcome ( exam results ) , we analysed the data of a 4-year prospect i ve study performed with 787 3rd-year medical students ( 111 groups of 5–10 participants ) taking an obligatory problem-based learning (PbL)-course of basic pharmacology . We compared peer tutors ( undergraduate medical students , ≥4th year ) , non-expert ( junior ) staff tutors ( physicians , pharmacists , veterinarians , biologists , or chemists during postgraduate education ) , and expert ( senior ) staff tutors ( completed postgraduate education ) . Evaluation scores related to PbL gave the highest values for senior staff-led groups . The tutor 's performance score of peer-led groups did not differ from those of staff-led groups , but the score obtained from groups tutored by junior staff was lower than that obtained with senior staff tutors . Students ' weekly preparation time tended to be lower in peer-led groups , while learning time spent specifically on exam preparation seemed to be increased compared to PbL-groups of staff tutors . As a putative confounding variable , tutors ' experience in coaching PbL-groups was also investigated . Groups led by experienced tutors , defined as tutors with at least one term of previous PbL tutoring , were found to have significantly higher evaluation scores . Interestingly , neither tutors ' subject-matter expertise ( peer students , junior staff , or senior staff ) nor their teaching- method expertise showed any influence on PbL-groups ' mean test scores in a written exam . This indicates that the effect of tutor expertise on the learning process is not associated with a difference in learning outcome when just factual knowledge is assessed by traditional methods OBJECTIVES Bedside sonography is a growing field of medicine , but there is little evidence about how to teach it to medical students . A peer-mentoring system may help pre clinical medical students learn bedside sonography . METHODS In 2008 and 2009 , participating first-year medical students completed an image recognition test at 0 , 2 , and 4 months and were r and omized to an early or a late intervention group . In h and s-on sessions , senior medical students taught the early intervention group how to perform a Trinity hypotensive ultrasound protocol between months 0 and 2 and then taught the late intervention group the Trinity protocol between months 2 and 4 . Participants completed a practical examination at month 4 . We measured the improvement in knowledge after the intervention and retention of knowledge and skills in the early intervention group at month 4 . First-year medical students completed precourse and postcourse surveys about comfort and skills with sonography . RESULTS Eighty-six first-year medical students enrolled ; 79 completed the precourse survey ; 54 completed all knowledge tests ; 52 completed the practical examination ; and 49 completed the postcourse survey . Of the 125 non participants , 109 completed the precourse survey , and 25 completed the postcourse survey . Participants ' knowledge scores increased by 30 % after the intervention . The early intervention group retained 92 % of the knowledge gained . Thirty-six percent of participants were able to complete the Trinity protocol in 15 minutes during the practical examination , with no significant difference between the early and late intervention groups . Participants responded positively about the experience and indicated that h and s-on sessions were helpful . CONCLUSIONS Peer mentoring is a useful method for teaching sonography to pre clinical medical students
Output:
| Although some studies demonstrated effective learning outcomes result ing from near-peer teaching , others were inconclusive .
The studies review ed focused on cognitive and psychomotor abilities of learners . |
MS211861 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE To compare the efficacy of immediate functionally loaded implants placed with a flapless procedure ( test group ) versus implants placed after flap elevation and conventional load-free healing ( control group ) in partially edentulous patients . MATERIAL S AND METHODS Forty patients were r and omized : 20 to the flapless immediately loaded group and 20 to the conventional group . To be immediately loaded , implants had to be inserted with a minimum torque > 45 Ncm . Implants in the immediately loaded group were provided with full acrylic resin temporary restorations the same day . Implants in the conventional group were submerged ( anterior region ) or left unsubmerged ( posterior region ) and were left load-free for 3 months ( m and ibles ) or 4 months ( maxillae ) . Provisional restorations were replaced with definitive single metal-ceramic crowns 1 month postloading . Outcome measures were prosthesis and implant failures , biological and prosthetic complications , postoperative edema , pain , and use of analgesics . Independent sample chi2 tests , Mann-Whitney tests , t tests , and paired t tests were used with a significance level of .05 . RESULTS Fifty-two implants were placed in the flapless group and 56 in the conventionally loaded group . In the flapless group , 1 flap had to be raised to control the direction of the bur and 1 implant did not reach the planned primary stability and was treated as belonging to the conventional group . After 3 years no dropouts or failures occurred . There was no statistically significant difference for complications ; however , patients in the conventional group had significantly more postoperative edema and pain and consumed more analgesics than those in the flapless group . Osstell values were significantly higher at baseline in the flapless group ( P = .033 ) . When comparing baseline data with years 1 , 2 , and 3 within each group , mean Osstell values of the flapless group did not increase , whereas there were statistically significant increases in the Periotest values . CONCLUSIONS Implants can be successfully placed flapless and loaded immediately without compromising success rates ; the procedure decreases treatment time and patient discomfort OBJECTIVE The purpose of this prospect i ve clinical study was to evaluate peri-implant soft-tissue conditions and esthetic fulfillment during a 3-year follow-up period following prosthetic rehabilitation . MATERIAL AND METHODS As part of a prospect i ve multi-center study , 152 ITI dental implants were placed in 80 patients in the maxillary anterior region . Fifty-nine crowns ( 38.82 % ) were cement retained , while 93 ( 61.18 % ) crowns were screw retained . At loading and 3 , 6 , 12 and 36 months post-loading , modified plaque index ( MPI ) , sulcus bleeding index ( SBI ) , keratinized mucosa ( KM ) , gingival level ( GL ) , and esthetic fulfillment were recorded . RESULTS All patients completed the study and no complications were reported . While statistically not significant at all time points , cement-retained crowns seemed to present a worsening trend in MPI and SBI scores . Interestingly , screw-retained crowns seemed to present an opposite picture , their MPI and SBI scores improved over time . While plaque accumulation , prophylaxis and depth of crown margin significantly affected levels of sulcus bleeding , prophylaxis alone played a key role in reducing plaque accumulation . No soft tissue recession was observed in either cement- or screw-retained crowns up to 3 years post-loading . Esthetic fulfillment survey revealed that patients did not have a preference for crown types ; however , dentists favored cement-retained over screw-retained crowns . CONCLUSIONS Peri-implant soft tissues responded more favorably to screw-retained crowns when compared with cement-retained crowns . However , no soft-tissue recession was observed in either type of crowns . Cement-retained crowns were preferred by dentists , while patients were equally satisfied with either type of crowns they received The aim of this study was to evaluate the survival and success rates of immediately restored implants with s and blasted , large-grit , acid-etched ( SLA ) surfaces over a period of 5 years . Twenty patients ( mean age , 47.3 years ) received a total of 21 SLA wide-neck implants in healed m and ibular first molar sites after initial periodontal treatment . To be included in the study , the implants had to demonstrate primary stability with an insertion torque value of 35 Ncm . A provisional restoration was fabricated chairside and placed on the day of surgery . Definitive cemented restorations were inserted 8 weeks after surgery . Community Periodontal Index of Treatment Needs ( CPITN ) indices and the radiographic distance between the implant shoulder and the first visible bone-implant contact ( DIB ) were measured and compared over the study period . The initial mean CPITN was 3.24 , and decreased over the study period to 1.43 . At the postoperative radiographic examination , the mean DIB was 1.41 mm for the 21 implants , indicating that part of the machined neck of the implants was placed slightly below the osseous crest . The mean DIB value increased to 1.99 mm at the 5-year examination . This increase proved to be statistically significant ( P < .0001 ) . Between the baseline and 5-year examinations , the mean bone crest level loss was 0.58 mm . Success and survival rates of the 21 implants after 5 years of function were 100 % . This 5-year study confirms that immediate restoration of m and ibular molar wide-neck implants with good primary stability , as noted by insertion torque values of at least 35 Ncm , is a safe and predictable procedure BACKGROUND Long-term follow-up studies ( i.e. , over 5 years ) , focusing on prosthetic outcomes and maintenance of implant-supported reconstructions in the edentulous maxilla , are scarce in the literature . PURPOSE The purpose of this study was to evaluate and report 10-year data on outcomes and maintenance of screw-retained implant-supported full-arch casted titanium-resin prostheses in the edentulous maxilla . MATERIAL S AND METHODS In the r and omized control trial cohort of 24 patients , the outcome and maintenance of 23 bridges were registered . RESULTS One patient dropped out of the study prior to the 10-year control . Of the 23 remaining patients , 21 still had their original frameworks ; one framework fractured after 8 years and one was remade after 7 years to create better support for the acrylic . The remaining 23 prostheses showed criteria of success , survival , and failure in 9 , 82 , and 9 % , respectively . Tightening of two assembly screws was necessary in one patient . No detrimental effects were seen because of long cantilever extensions or opposing dentition . A total of 4.7 resin-related complications per prosthesis were observed ; tooth fracture was the most common prosthetic complication . There was an indication of greater prevention in the number of resin-related complications with the use of lingual gold onlay compared with a resilient mouth guard , 0.71 and 1.67 , respectively per bridge . The bridges were removed and reinserted 0.83 times per patient . No abutment or abutment screw fractures were registered . CONCLUSION Fracture or wear of the reconstruction material s were considered predictable risks when using resin-based suprastructure material s. Status of opposing dentition and length of cantilevers did not confer additional risk . The use of a lingual gold onlay indicated prevention of resin-related complications . Future research should focus on the suprastructure material s to predict better overall treatment results of implant-supported full-arch bridges in the edentulous maxilla PURPOSE The possibility of expediting dental implant therapy by early or immediate loading protocol s requires long-term clinical investigation . The aim of this prospect i ve cohort trial was to determine the 3-year implant success rate and prosthesis complications associated with functional loading 3 weeks after 1-stage placement of Astra Tech single-tooth implants replacing maxillary anterior teeth . A secondary objective was to determine peri-implant tissue responses at these implants . MATERIAL S AND METHODS The peri-implant bone and mucosal conditions of 43 implants in 39 subjects were radiographically and clinical ly measured 3 years after implant placement . RESULTS Of the 48 patients originally treated , 39 patients and 43 implants were examined at the 3-year time point . Three of 54 implants failed within the first year . No additional failures were recorded since the 12-month reporting period . Peri-implant bone levels were stable for the 3-year period following implant placement . The change in marginal bone levels after 3 years was 0.42 + /- 0.59 mm . Papilla growth was measured at 1 and 3 years ( 0.61 + /- 0.95 mm and 0.74 + /- 0.79 mm , respectively ) . The buccal peri-implant tissue dimensions at the gingival zenith also increased at 1 and 3 years ( 0.34 + /- 0.94 mm and 0.51 + /- 1.42 mm , respectively ) . No abutment screw loosening or fracture occurred . DISCUSSION AND CONCLUSIONS Early loading of endosseous dental implants placed in healed ridges offers select benefits to clinicians and their patients PURPOSE To present long-term clinical and radiographic data on single-implant treatment in the anterior maxilla and to compare these results with comparable data of central implants supporting fixed prostheses in the edentulous maxilla . MATERIAL S AND METHODS A total of 38 patients consecutively restored with 47 single-implant crowns in the anterior maxilla were included in the single-implant ( study ) group . The implants in the edentulous group ( control ) were included by r and omly selecting one of the central implants ( closest to midline ) from 76 consecutively treated edentulous patients . Mean age was 25.4 years ( SD : 10.0 ) and 60.1 years ( SD : 11.6 ) at inclusion ( P < .001 ) for the study and control groups , respectively . Clinical and radiographic data were retrospectively retrieved from files holding up to 15 years of function in both groups . RESULTS No implants in the study group were lost ( cumulative success rate : 100 % ) , while 3 implants in the control group were lost ( cumulative success rate : 95.4 % ) . Ten single crowns were replaced ( 15-year cumulative survival rate : 77.0 % ) , and the study group showed more mucosal problems and fistulas compared to the implants in the control group ( P < .05 ) . Loose screws were a common problem in the single-implant group during the first 5 years of function , but bone loss did not differ significantly between patients with stable and loose screws/fistulas ( P > .05 ) or between study and control implants after 15 years ( P > .05 ) . CONCLUSIONS There is an obvious difference between the survival of the implants ( 100 % ) and original implant crowns ( 77 % ) in the study group . The present early single-implant restorations showed significantly more mechanical/fistula problems compared to central implants in the edentulous maxilla ( P < .05 ) , but bone response was similar for both groups during 15 years of follow-up . Bone loss was not affected by the level of the implant head in relation to the cementoenamel junction of adjacent teeth , nor was it affected by mechanical or mucosal problems or persistent fistulas of the single implants during the entire follow-up period Screw loosening is considered to be a common problem with both screw - retained and cemented implant restorations . A wider abutment platform , as well as using a torque driver to tighten specifically design ed screws may help prevent this loosening . However , there has been no clinical study evaluating either of these . To longitudinally compare the frequency of screw loosening in st and ard diameter , ( 3.75 and 4.0 mm ) implant supported prostheses to that of wide diameter , ( 5.0 and 6.0 mm ) implant supported prostheses that were h and tightened , and to evaluate whether using a torque driver would minimize or prevent this problem , if screw loosening occurred . A total of 213 dental implants in 106 patients were included in this prospect i ve longitudinal study . Of the implants 68 were wide diameter and 145 were st and ard diameter implants . Wide diameter implants showed 5.8 % screw loosening , while st and ard diameter implants showed 14.5 % screw loosening after insertion with only h and torquing . When these loose screws were tightened with a torque driver , there was no more loosening of screws . Within the limitations of this study , the wide diameter implants tested showed less screw loosening than the st and ard diameter implants when h and torqued . Additionally , within the scope of our study , using a torque driver to tighten the screws with the recommended force prevented this loosening from reoccurring in all cases The purpose of this study was to evaluate the survival and success of screw- versus cement-retained implant crowns over a 5-year period . This was a multi-center prospect i ve cohort study , consisting of patients who had ≥1 dental implant placed and restored in the anterior maxilla over a 5-year period . The primary predictor variable was the type of restoration ( screw- versus cement-retained ) . The outcome variables were clinician- or patient-reported measures related to soft tissue and restoration quality . Descriptive and bivariate statistics were computed to compare the screw- versus cement-retained groups . Kaplan – Meier statistics were computed for implant survival . Information was collected for
Output:
| Although no statistical difference was found between cement- and screw-retained reconstructions for survival or failure rates , screw-retained reconstructions exhibited fewer technical and biologic complications overall .
There were no statistically significant differences between the failure rates of the different reconstruction types ( I-SCs , I-FDPs , full-arch I-FDPs ) or abutment material s ( titanium , gold , ceramic ) .
The failure rate of cemented reconstructions was not influenced by the choice of a specific cement , though cement type did influence loss of retention |
MS211862 | ***TASK*** the task is to summarize an input biomedical literature 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: Levels of the stress-sensitive hormone cortisol increase dramatically in the first 30 - 40min after waking , an effect known as the cortisol awakening response ( CAR ) . There is considerable cross-sectional evidence that psychosocial stress is associated with an increased CAR , and the CAR has been found to be altered in the presence of stress-related diseases , including major depressive disorder ( MDD ) . To date , no prospect i ve longitudinal studies have examined whether individual differences in the CAR serve as a premorbid risk factor for MDD . In a sample of 230 late adolescents , clinical diagnoses of MDD were predicted from the CAR as well as other indicators of basal cortisol functioning gathered 1 year earlier , including : waking cortisol levels , bedtime cortisol levels , the size of the CAR , average cortisol , and the slope of the diurnal cortisol rhythm across the waking day . Age and gender , health and health behaviors , baseline neuroticism , exposure to stressful life events and past episodes of mood and anxiety disorders were included as covariates , to help ensure effects are attributable to the CAR rather than related variables . A higher baseline CAR was associated with a significantly increased risk of developing MDD by follow-up , even when excluding individuals with baseline MDD . No other baseline cortisol measures were significant prospect i ve predictors of MDD . In summary , the CAR is a significant prospect i ve risk factor for the development of MDD in young adults , providing some support for the possibility that a heightened CAR may play a role in the etiology of major depressive disorder BACKGROUND Sex differences in stress responses may be one mechanism underlying gender differences in depression . We hypothesized that men and women would show different adrenocortical responses to different stressors . In particular , we predicted that women would show greater responses to social rejection stressors , whereas men would demonstrate greater responses to achievement stressors . METHODS Following a rest session in which they habituated to the laboratory , 50 healthy volunteers ( 24 men and 26 women , mean age 19.1 , SD = 1.13 ) were r and omly assigned to achievement or rejection stress conditions . The achievement condition involved a mathematical and a verbal challenge ; the rejection condition involved two social interaction challenges . Self-reported affect and salivary cortisol were measured throughout each stress session ( baseline , stress , and poststress periods ) . RESULTS There were no sex differences in mood ratings following the stressors ; however , cortisol responses showed the predicted gender by condition by time interaction . Men showed significantly greater cortisol responses to the achievement challenges , but women showed greater cortisol responses to the social rejection challenges . CONCLUSIONS Women appear more physiologically reactive to social rejection challenges , but men react more to achievement challenges . Women 's greater reactivity to rejection stress may contribute to the increased rates of affective disorders in women The current cross-sectional study investigated basal and stress-challenged hypothalamic-pituitary-adrenocortical ( HPA ) system function in 102 five-year old kindergarten children ( 59 boys , 43 girls ) who had been assessed by a comprehensive psychological and behavioral test battery . Baseline HPA system activity was significantly increased in girls when compared to boys ( p<0.001 ) . Furthermore , basal HPA system activity predicted a high hormonal release during stress with -- again -- girls showing higher hormonal responses than boys ( p<0.01 ) . Importantly , increased HPA system activity ( baseline and stress-challenged ) was significantly associated with hyperactivity/impulsivity and emotional problems in boys and with positive emotions in girls ( p<0.05 ) . These results suggest an occurrence of neurobiological alterations early in development . The observed neurobiological changes are gender specific already at the age of 5 years . Prospect i ve long-term follow up of the identified subjects with HPA axis alterations will clarify if these markers are predictive for the onset of psychiatric disorders Estrogens are reported to provide protection against the development of cardiovascular disease in women , but the mechanisms underlying these effects are not well defined . We hypothesized that estrogen might affect the hormonal responses to stress . We therefore studied cortisol , ACTH , epinephrine , norepinephrine , and norepinephrine spillover and hemodynamic responses to a 10-min mental arithmetic test in 12 perimenopausal women r and omized to 8 weeks of estrogen supplementation ( estradiol valerate , 2 mg daily ; n = 7 ) or placebo ( n = 5 ) . Total body and forearm norepinephrine spillover were measured by radiotracer methodology . After supplementation with estradiol , the increases in both systolic and diastolic blood pressure in response to mental stress were reduced , and cortisol , ACTH , plasma epinephrine and norepinephrine , and total body norepinephrine spillover responses to stress were significantly attenuated ( P < 0.05 in each case ) . Forearm norepinephrine spillover was unchanged by estrogen , and there was no change in any of the responses after placebo . We conclude that estrogen supplementation in perimenopausal women attenuates blood pressure , glucocorticoid , and catecholamine responses to psychological stress The current study sought to examine whether children 's spontaneous use of the emotion regulation strategies suppression and re appraisal during a psychosocial stress task was related to their cortisol and alpha-amylase responses to that task . Salivary cortisol and alpha-amylase responses to a psychosocial stress task were assessed in 158 10-year-old children ( 83 girls ) . The children completed a self-report question naire measuring use of re appraisal and suppression during the task . Results showed overall increases in cortisol and alpha-amylase in response to the stressor , with higher cortisol reactivity in girls than in boys . With regard to emotion regulation , more use of suppression was related to lower cortisol reactivity in girls , and lower alpha-amylase reactivity and quicker alpha-amylase recovery in all children . The use of re appraisal was not related to the children 's cortisol or alpha-amylase responses . The current study is the first to investigate the relation between the spontaneous use of re appraisal and suppression , and physiological stress responses to a psychosocial stressor in children . Our results indicate that re appraisal and suppression are used and can be measured even in 10-year-olds . At this age re appraisal appears ineffective at down-regulating physiological responses , while suppression was related to lower physiological responses . For cortisol reactivity there was a sex difference in the relation with suppression , indicating the importance of including sex as a moderator variable in research study ing stress reactivity and its correlates in this age group Data from five independent studies were reanalyzed in order to investigate the impact of age and gender on HPA axis responses to an acute psychosocial laboratory stress task . The total sample consisted of 102 healthy subjects with 30 older adults ( mean age : 67.3 y ) , 41 young adults ( mean age : 23.5 y ) , and 31 children ( mean age : 12.1 y ) . All participants were exposed to the Trier Social Stress Test ( TSST ) . The stress protocol caused highly significant ACTH and total plasma cortisol responses in older and younger male and female adults ( all p<0.0001 ) as well as salivary free cortisol responses in all six age and gender groups ( all p<0.0001 ) . Three-way ANOVAs for repeated measurement were applied to investigate the impact of age and gender on ACTH and cortisol responses . Results showed that the ACTH response to stress was higher in younger adults compared to older adults ( main effect : p=0.009 , interaction : p=0.06 ) . Post hoc analyses revealed that there was no age effect in the subgroup of women ( p = n.s . ) , while younger men had higher ACTH responses compared to older men ( p=0.01 ) . For total plasma cortisol , ANOVA results showed that the pattern of reactivity did not differ between age and gender groups ( all interactional effects p = n.s . ) , although older females had hightened overall cortisol levels compared to the other groups , as proofed in post hoc analyses ( all p<0.05 ) . For free salivary cortisol , a significant main effect of gender ( p=0.05 ) and an almost significant three-way-interaction ( p=0.09 ) emerged . Post hoc analyses showed an elevated overall free salivary cortisol response in elderly men compared to elderly women ( p=0.006 ) , while no gender differences emerged in neither young adults nor children ( both p = n.s . ) . In sum , the stressor induced significant HPA axis responses in all age and gender groups . The observed ACTH response patterns in young and elderly adults may suggest that a heightened hypothalamic drive in young men decreases with age , result ing in similar ACTH responses in elderly men and women . Alternative interpretations are also discussed . The data also supports the idea of a greater adrenal cortex sensitivity to ACTH signals in young females . Free salivary cortisol responses were elevated in elderly men compared to elderly women , an effect which can not be explained by gender differences in perceived stress responses to the TSST . It can be speculated if corticosteroid binding globulin ( CBG ) and /or sex steroids are important modulators of these effects Sex differences in rates of internalizing disorders have been attributed in part to heightened sensitivity to stress in females . While the sex difference in disorder rates becomes most pronounced in adolescence , developmental research suggests that stress reactivity in girls may be related to elevated internalizing symptoms even in childhood . We therefore examined whether child sex moderated associations between symptoms of psychopathology and cortisol reactivity to a st and ardized stress task in 409 three-year-old community-dwelling children . Anxious symptoms were associated with elevated cortisol reactivity , but only in girls . Externalizing symptoms were unrelated to baseline cortisol or cortisol reactivity , and no evidence for moderation by child sex was found . Results suggest that cortisol reactivity to stress in early childhood has a sex-specific association with girls ' internalizing symptoms This study investigates basal levels of cortisol and dehydroepi and rosterone ( DHEA ) , and their relation to gender and pubertal development , in healthy children and adolescents . Salivary cortisol and DHEA levels were examined in 129 normally developing subjects aged eight to 16 years . Subjects provided morning ( 08:00 h ) and evening ( 20:00 h ) saliva sample s over four consecutive days . Pubertal stage was assessed using Tanner stage sketches , and subjects were grouped according to their general status of pubertal development ( pre-early puberty : Tanner stageII ) . Results showed that morning salivary cortisol in mid-postpubertal girls was greater than in mid-postpubertal boys , but not pre-early pubertal girls and boys . Mean levels of salivary DHEA were greater in mid-postpubertal boys and girls than in pre-early pubertal boys and girls . Changes in hypothalamic-pituitary-adrenal ( HPA ) axis function that occur during puberty may have implication s for immediate and long-term adolescent health OBJECTIVE Our purpose was to determine the pattern of reactivity to stress in premenopausal and postmenopausal women and to assess the effects of estrogen . STUDY DESIGN A behavioral stress test was given to premenopausal ( n = 13 ) and postmenopausal women ( n = 36 ) . Biophysical and neuroendocrine responses were measured during and on completion of the stress test . The postmenopausal women were then r and omized to placebo or transdermal estradiol treatment for 6 weeks , at which time another behavioral stress test was given . RESULTS Stress reactivity to math and speech tasks elicited significantly greater systolic blood pressure responses in postmenopausal women compared with premenopausal women ( p < 0.05 ) . On retesting , significant biophysical responses that were present during the initial stress testing were still present ( p < 0.05 ) in the placebo group but were blunted with estrogen treatment . Plasma corticotropin , cortisol , and rostenedione , and norepinephrine increased during testing to a similar degree in premenopausal and postmenopausal women ; this response was maintained after placebo treatment . Postmenopausal women treated with estrogen had blunted responses . CONCLUSION Significant differences in responses to psychologic stress exist in premenopausal and postmenopausal women . The lack of adaptation may account in part for the increased risk of cardiovascular disease in postmenopausal women . Estrogen appears to blunt the stress-induced response OBJECTIVE Consistent sex differences in regulation of the hypothalamic pituitary adrenocortical ( HPA ) axis have been shown in animal models and emerge over puberty . However , parallel work in humans is lacking despite implication s for elucidating the emergence of sex differences in depression over puberty . We investigated sex differences in HPA response to corticotropin releasing hormone ( CRH ) challenge over puberty in a carefully screened normative sample . METHODS Participants were 68 healthy children ( 41 % girls ) , ages 6 - 16 , with no personal or family history of psychiatric disorder . Pubertal maturation was determined by Tanner staging . Following 24h of adaptation , 9 - 10 plasma cortisol sample s were collected over 30 - 40 min pre-infusion baseline , 1 μg/kg CRH infusion , and 90 - 180 min post-infusion recovery . Thirty-seven participants completed 2 + CRH challenges allowing inclusion of cross-sectional and longitudinal data in all analyses . The influence of gender and pubertal maturation on parameters of cortis
Output:
| Discussion Sex differences in HPA axis reactivity appear to be present in childhood , although evidence is not unequivocal . |
MS211863 | ***TASK*** the task is to summarize an input biomedical literature 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: Recent developments in dressings for intravenous access sites include a transparent dressing which does not retain moisture . This article describes a r and omised controlled trial to compare the new dressing with a st and ard dressing . There was no difference in sepsis rates between the two groups , and both methods had advantages and disadvantages . The authors suggest that cost may be a factor in choice of dressing The objective of this study was to assess the risk of bacteremia , estimate the cost and evaluate the quality of life by using a transparent dressing ( TD ) versus ( vs ) a dry gauze ( DG ) on the exit site of long term central I.V. catheters ( LTCC ) of hemodialysis patients . This 6-months preliminary study was conducted on 58 patients ( pts ) r and omized to receive DG replaced 3 times/week ( 29 pts ) or TD replaced every 7 days ( 29 pts ) . Data on patients , conditions of the exit site , local infection , bacteremia , quality of life and cost related to each type of dressing were collected . Two pts in the DG group experienced bacteremia related to their LTCC vs 1 pt in the group TD . A total of 7 ( DG ) vs 13 ( TD ) pts experienced skin condition changes at the catheter exit site . Some skin reactions , erythema and pruritus , did occur initially in the group TD and was due in part to insufficient drying time of the skin preparation solution . The estimated individual , weekly costs for using the DG was $ 7.60 vs $ 4.72 Canadian dollars for the TD . The SF-36 ™ scores did not show a significant difference between the 2 groups during the study ( 3.8 ( PCS ) , 6.4 ( MCS ) at study end ) . Although this study was statistically underpowered , it suggests that the incidence of bacteremia was not increased with the use of a TD . Moreover , the use of a TD allowed fewer dressing changes , lowered total treatment costs , with no observed unfavorable impact on the quality of life and without significant local complications of the exit site . Based on the positive results observed in this pilot study , further study is warranted to examine the cost effectiveness of long-term use of TD dressings on dialysis catheter exit sites A prospect i ve r and omized clinical trial has been conducted to compare the clinical performance , with prolonged use , of two film-type transparent dressings used over subclavian and jugular single-lumen venous catheters . ' OpSite ' , a traditional dressing with a moderate moisture vapour permeability was compared with a new dressing of high moisture vapour permeability , ' OpSite IV3000 ' . Information was collected daily to assess the nature and incidence of complications , dressing durability and the ease of application and removal . One hundred and one patients provided two well-matched population s receiving a total of 153 dressings for a total of 780 catheter-days . No differences between the two dressings were noted with respect to the incidence of complications , such as moisture accumulation or lifting , and dressing durability . The low incidence of catheter-related sepsis ( ' OpSite ' group three episodes and ' OpSite IV3000 ' group one episode ) suggests that transparent dressings do not increase this risk . This clinical study demonstrated the new ' OpSite IV3000 ' to be easier to h and le , leading to better application , improved catheter fixation and easy removal A comparative study of ' Op-site ' and ' Nobecutan-gauze ' dressings for central venous lines was performed . Seventy-seven long antebrachial and 68 infraclavicular subclavian catheters were studied . A statistically significant reduction in the incidence of positive cultures from the catheter tip and from the skin puncture site was found with the ' Nobecutan-gauze ' dressing . No difference in the incidence of catheter-related septicaemia was found . The theoretical advantage of being able to observe signs of inflammation when ' Op-site ' was used did not reduce the incidence of local infection at the skin puncture site . In conclusion we found that a ' Nobecutan-gauze ' dressing was a satisfactory alternative to an ' Op-site ' dressing The incidence of catheter-related sepsis associated-with the use of Tegaderm or Opsite IV3000 dressings on 100 critically ill patients with liver disease was studied . All the patients had central venous catheters in situ and they were r and omly assigned to one of the two dressings . In this study the sites of insertion were assessed at each dressing change , together with any fluid under the dressing . No statistically significant difference between the two dressings was found in accumulation of fluid , skin microbial colonization , local infection or systemic infection of patients in our sample . There was no apparent advantage to using the more permeable Opsite IV3000 dressing The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . Patients having central venous catheters for three or more days were prospect ively r and omized to receive a transparent ( n = 58 ) or gauze ( n = 57 ) dressing to compare the incidence of insertion site colonization , local catheter-related infection , and catheter-related sepsis . Quantitative cultures of the catheter insertion site ( 25 cm2 ) revealed significantly greater colonization ( P less than or equal to .009 ) after 48 h in the transparent versus the gauze dressing group . Local catheter-related infection occurred significantly more often ( P = .002 ) in the transparent ( 62 % ) than in the gauze group ( 24 % ) . Seven episodes of catheter-related bacteremia occurred in the transparent group ( 16.6 % ) and none in the gauze group ( P = .015 ) . Stepwise logistic regression analysis revealed that cutaneous colonization at the insertion site of greater than or equal to 10(3 ) cfu/mL ( relative risk , 13.16 ) and difficulty of insertion ( relative risk , 5.39 ) were significant factors for catheter-related infection . These data suggest that transparent dressings are associated with significantly increased rates of insertion site colonization , local catheter-related infection , and systemic catheter-related sepsis in patients with long-term central venous catheters PURPOSE / OBJECTIVES To determine the effect of two central venous catheter ( CVC ) dressing protocol s on catheter-related infections in hospitalized patients with long-term tunneled catheters undergoing an autologous bone marrow transplant ( BMT ) , to determine the prevalence of long-term CVC-related infections in this population , and to identify other factors in the study sample related to long-term CVC infection . DESIGN Experimental . SETTING BMT unit of a regional oncology center in a tertiary care hospital . SAMPLE The sample consisted of 101 adult patients with cancer with long-term , tunneled CVCs inserted in the operating room on admission for autologous BMT . METHODS Patients r and omly were assigned to one of two dressing-change procedure groups . The control group received the current st and ard of care for patients receiving BMT -- a dry , sterile gauze dressing ( DSGD ) changed every 24 hours . The experimental group received Opsite 3000TM ( Smith + Nephew Ltd. , Massilon , OH ) transparent moisture vapor permeable dressings ( MVPD ) changed weekly . MAIN RESEARCH VARIABLES CVC infection rates , frequency of IV tubing changes , immune status , duration of catheter use , occurrence and outcome of catheter occlusion , and use of a catheter for total parenteral nutrition . FINDINGS Research ers determined the difference in CVC-related infections between the two groups and the impact of select variables on CVC-related infection . When all categories of CVC-related infection ( i.e. , suspected , sepsis , tunnel ) were considered , no statistical difference was found in the likelihood of the groups remaining infection-free ( p = 0.76 ) over time . CVC sepsis occurred in one patient in the DSGD group and five patients in the MVPD group ; however , this difference was not statistically significant over time ( p = 0.067 ) . CONCLUSIONS Development of CVC sepsis or tunnel infection in close proximity to the time of CVC surgical placement suggests that factors other than the assigned dressing were associated with the occurrence of CVC-related infection in three cases . Although the MVPD group required dressing changes more frequently than every seven days ( as specified by the protocol ) because of exit-site drainage and nonocclusiveness , transparent dressings were more cost-effective than daily gauze dressings in this population . IMPLICATION S FOR NURSING PRACTICE For adults undergoing autologous BMT , either DSGD or transparent CVC dressing can be used safely based on patient preference and skin tolerance to the dressing material Patients undergoing bone marrow transplant ( BMT ) are at great risk of infection and sepsis . Long-term central catheters ( LTCCs ) , required for IV therapy , can be a portal of entry for infectious agents . This r and omized , prospect i ve study compared two types of catheter dressings in 98 patients undergoing BMT : a dry sterile gauze dressing ( DSGD ) changed daily and a transparent adherent dressing ( TAD ) changed every four days . Study outcomes included incidence and severity of local and systemic complications , patient assessment of comfort , and calculation of nursing time . One case of catheter-related infection occurred during the study . No significant differences existed between the two dressings in the incidence of positive skin cultures or local complications with the exception of skin irritation . The TAD caused less skin irritation , was preferred by patients , cost less , and required less nursing time . The findings indicate that TADs provide a safe , comfortable , and cost-effective alternative to DSGDs for patients undergoing BMT and receiving antibiotic support during aplasia A prospect i ve , r and omized study compared the use of Opsite and st and ard gauze/tape dressings in 261 patients receiving parenteral nutrition . Eighty-four patients had a source of external drainage and were evaluated as a separate group . Catheter-related sepsis was assessed by blood culture , catheter tip culture , clinical sepsis , and clinical defervescence of fever after catheter removal . Although no statistically significant difference between Opsite and st and ard dressings could be identified , Opsite-treated patients consistently had increased parameters of catheter-related sepsis in all comparisons . As used here , Opsite is probably not a suitable catheter dressing system for parenteral nutrition Central venous lines are now common in children who need a permanent form of intravenous access . These lines frequently become infected . This study compared the effects of different antiseptics ( Hibiclens [ chlorhexadine 4 % ; Stuart Pharmaceutical , Wilmington , DE ] and Betadine [ povidone-iodine , Clini Pad Corp , Guilford , CT ] ) used to clean the skin as well as the dressings used to cover the exit site ( Tegaderm [ 3-M Medical-Surgical Division , St Paul , MN ] and gauze ) on microorganism growth on the skin in a pediatric oncology population . Sixty subjects were recruited from the oncology and bone marrow transplant units of Children 's Hospital in Boston , MA . The subjects were r and omly assigned to one of four dressing groups . These included : 1 , Betadine and Tegaderm ; 2 , Betadine and gauze ; 3 , Hibiclens and Tegaderm ; and 4 , Hibiclens and gauze . Dressings were done on a Monday-Wednesday-Friday basis . Quantitative cultures were obtained before the first and after the fifth dressing changes . There were no significant differences in incidence of bacterial growth between dressing groups ( F = 1.05 , P = .377 ) . Redness ( F = 3.01 , P = .037 ) and swelling ( F = 2.75 , P = .051 ) were more frequently seen in Betadine groups . Boys were more often infected than girls . ( χ 2 = 4.075 , P = .044 Abstract Central venous catheterization is one of the important sepsis reasons in surgical patients . In this r and omized controlled study , the effect of the frequency and type of catheter site care , as well as age , coexisting malignancy or diabetes mellitus , total parenteral nutrition administration and antibiotics use , on central venous catheter infection was investigated . Seventy-two single-lumen polyurethane catheters were included . In group I ( n : 33 ) , a transparent occlusive dressing was applied to the insertion site and not removed for 7 days unless there were signs of local infection . In group II ( n : 39 ) , daily site care was done with povidone-iodine 10 % solution and a new sterile gauze was applied . Chi-square , linear correlation and multiple regression tests were used for statistical analysis . Mean duration of catheters was 8 ±4 days . There was no catheter-related sepsis . Ten ( 13.9 % ) patients had positive catheter tip cultures of whom three had site infection as well . The incidence of site and tip infections were not significantly different in group I and II ( p > 0.05 ) . Site infection and age younger than 60 years significantly increased the rate of tip infection ( p : 0.004 and p : 0.02 respectively ) . Total parenteral nutrition administration was associated with higher rate of tip infection ( p : 0.06 ) . Coexisting malignancy or diabetes mellitus , duration of catheter and antibiotics use did not have any significant effect on the rate of central venous catheter infe
Output:
| There was no evidence of a difference between highly permeable polyurethane dressings and other polyurethane dressings in the prevention of catheter-related bloodstream infection ( low quality evidence ) . |
MS211864 | ***TASK*** the task is to summarize an input biomedical literature 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 There is a paucity of data regarding the association between glycosylated hemoglobin ( HbA1c ) variability and risk of microvascular complications in adolescents with type 1 diabetes ( T1D ) . OBJECTIVE To investigate the association between HbA1c variability and risk of microvascular complications in adolescents with T1D . DESIGN Prospect i ve cohort study from 1990 to 2014 ( median follow-up , 8.1 y ) . SETTING Tertiary pediatric hospital . PARTICIPANTS A total of 1706 adolescents ( aged 12 - 20 minimum diabetes duration 5 y ) with median age of 15.9 years ( interquartile range , 14.3 - 17.5 ) and diabetes duration of 8.1 years ( 6.3 - 10.8 ) . MAIN OUTCOME MEASURES Glycemic variability was computed as the SD of all HbA1c measurements ( SD-HbA1c ) after diagnosis . Retinopathy was detected using 7-field fundal photography , renal function assessed using albumin excretion rate , peripheral neuropathy detected using thermal and vibration threshold testing , and cardiac autonomic neuropathy ( CAN ) detected using time- and frequency-domain analyses of electrocardiogram recordings . Generalized estimating equations were used to examine the relationship between complications outcomes and HbA1c variability , after adjusting for known risk factors , including HbA1c , diabetes duration , blood pressure , and lipids . RESULTS In multivariable analysis , SD-HbA1c was associated with early retinopathy ( odds ratio [ OR ] 1.32 ; 95 % confidence interval , 1.00 - 1.73 ) , albuminuria ( OR 1.81 ; 1.04 - 3.14 ) , increased log10 albumin excretion rate ( OR 1.10 ; 1.05 - 1.15 ) and CAN ( OR 2.28 ; 1.23 - 4.21 ) but not peripheral neuropathy . CONCLUSIONS Greater HbA1c variability predicts retinopathy , early nephropathy , and CAN , in addition to established risk factors , in adolescents with T1D . Minimizing long term fluctuations in glycemia may provide additional protection against the development of microvascular complications INTRODUCTION Osteoporosis is a growing health problem in patients with type 1 diabetes mellitus ( T1DM ) . The aim of this study was to determine the effects of a 9-month weight-bearing physical activity program on bone mineral density ( BMD ) and bone biomarkers in T1DM compared with healthy children . METHODS This was a r and omized controlled trial including 27 diabetic and 32 healthy children ( mean age = 10.5 ± 2.5 yr ) . Both T1DM and healthy participants were r and omized to either an exercise or a control group ( i.e. , four groups ) . At baseline and 9 months , total body ( TB ) , lumbar spine ( LS2-LS4 ) , femoral neck , and greater trochanter areal BMD ( aBMD ) and serum bone biomarkers ( osteocalcin , type 1 collagen cross-linking ) were measured . The intervention consisted of two 90-min sessions per week of weight-bearing physical activity ( ball games , jumping , rope skipping , and gymnastics ) . RESULTS Baseline variables were similar among groups . At 9 months , changes in TB ( T1DM = 0.035 ± 0.022 g·cm(-2 ) , healthy = 0.031 ± 0.017 g·cm(-2 ) ) and LS2-LS4 ( T1DM = 0.046 ± 0.038 g·cm(-2 ) , healthy = 0.063 ± 0.034 g·cm(-2 ) ) aBMD were statistically significant in the intervention groups and of similar magnitude between T1DM and healthy subjects . The level of type 1 collagen cross-linking ( T1DM = -0.12 ± 0.32 ng·mL(-1 ) , healthy = -0.36 ± 0.11 ng·mL(-1 ) ) decreased in the intervention groups but was not associated with TB aBMD changes . CONCLUSIONS Regular weight-bearing physical activity ( 180 min·wk(-1 ) , including ball games , jumping activities , and gymnastics ) improves total and LS2-LS4 bone mineral accretion in children with T1DM , in a similar magnitude to healthy subjects . We conclude that children with T1DM should be encouraged to practice regular physical activity to enhance peak bone mass and prevent osteoporosis later in life OBJECTIVES To evaluate the evolution of subcutaneous glucose ( SG ) after a st and ardized aerobic exercise in children and adolescents treated with continuous subcutaneous insulin infusion ( CSII ) or multiple daily injection ( MDI ) regimen before and after adaptation of insulin doses . RESEARCH DESIGN AND METHODS Eleven CSII- and 13 MDI-treated patients performed 2 30-minute sessions of moderate to vigorous ( 70 % of age-based maximal heart rate ) exercise on a treadmill under continuous glucose monitoring ( CGM ) . First sessions were scheduled without insulin modification ( TT#1 ) while patients performed second sessions ( TT#2 ) after preemptive algorithm-based insulin dose modifications . RESULTS While insulin adaptations did not modify immediate postexercise drops in blood glucose during TT#2 in either group , CSII-treated patients had their glucose control improved during TT#2 ( mean of 141 ± 56 mg/dL vs 144 ± 80 mg/dL in TT#1 ; P < .05 ) with up to 86 % of SG levels within targets during 16 hours postexercise . Contrarily , SG levels did not normalize during TT#2 in MDI-treated patients who experienced higher rates of hyperglycemia during the afternoon snack . As compared with TT#1 , CSII-treated patients had reduced rates of hypoglycemia during 4 hours post-TT#2 ( from 19.5 % to 2.1 % ; P < .01 ) and had shorter duration of nocturnal hypoglycemia ( 35.5 ± 12.8 vs 204.7 ± 165 minutes ; P = .04 ) whereas in the MDI group no changes in percentages of hypoglycemia were observed during TT#2 . CONCLUSION In our pediatric cohort , algorithmic adaptations of insulin doses were associated with better outcomes in terms of postexercise glucose control in patients with CSII therapy but not with MDI treatment This paper describes PEDro , the Physiotherapy Evidence Data base . PEDro is a web-based data base of r and omized controlled trials and systematic review s in physiotherapy . It can be accessed free of charge at http://ptwww.cchs.usyd.edu.au/pedro . The data base contains bibliographic details and abstract s of most English- language r and omized trials and systematic review s in physiotherapy , and of many trials and review s in other language s. Trials on the data base are rated on the basis of their method ological quality so that users of the data base can quickly identify trials of high quality . Trials and systematic review s are extensively indexed to facilitate search ing . PEDro provides an important information re source to support evidence -based clinical practice BACKGROUND Patients with type 1 diabetes mellitus ( T1DM ) may experience poor muscle health as a result of chronic hyperglycemia . Despite this , muscle function in children with T1DM with good or poor glycemic control has yet to be examined in detail . OBJECTIVE To assess differences in muscle-related fitness variables in children with T1DM with good glycemic control ( T1DM-G ) , as well as those with poor glycemic control ( T1DM-P ) , and non-diabetic , healthy controls . SUBJECTS Eight children with T1DM-G [ glycosylated hemoglobin ( HbA1c ) ≤ 7.5 % for 9 months ] , eight children with T1DM-P ( HbA1c ≥ 9.0 % for 9 months ) , and eight healthy controls completed one exercise session . METHODS Anaerobic and aerobic muscle functions were assessed with a maximal isometric grip strength test , a Wingate test , and an incremental continuous cycling test until exhaustion . Blood sample s were collected at rest to determine HbA1c at the time of testing . Physical activity was monitored over 7 d using accelerometry . RESULTS Children with T1DM-P displayed lower peak oxygen consumption ( VO2peak ) values ( mL/kg/min ) compared to healthy controls ( T1DM-P : 33.2 ± 5.6 , controls : 43.5 ± 6.3 , p < 0.01 ) , while T1DM-G ( 43.5 ± 6.3 ) had values similar to controls and T1DM-P. There was a negative relationship between VO2peak and HbA1c% ( r = -0.54 , p < 0.01 ) . All groups were similar in all other fitness variables . There were no group differences in physical activity variables . CONCLUSION Children with T1DM-G did not display signs of impaired muscle function , while children with T1DM-P have signs of altered aerobic muscle capacity
Output:
| FINDINGS Both observational and interventional studies showed considerable agreement that supervised regular moderate to vigorous physical activity ( MVPA ) is more effective on adiposity and cardiorespiratory fitness than habitual PA .
Further , it was reported that PA of different intensities improves insulin sensitivity and decreases daily insulin dosage .
Results of glycemic control were equivocal .
A consistent agreement among the studies revealed a considerable benefit of regular habitual PA of light to moderate intensity on blood glucose regulation and lipid profile . |
MS211865 | ***TASK*** the task is to summarize an input biomedical literature 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: & NA ; Adverse events in r and omized controlled trials of noninvasive , pharmacologic analgesics are frequently incompletely or inconsistently reported . A comprehensive reporting checklist is proposed to improve disclosure of adverse effects . & NA ; The development of valid and informative treatment risk – benefit profiles requires consistent and thorough information about adverse event ( AE ) assessment and participants ’ AEs during r and omized controlled trials ( RCTs ) . Despite a 2004 extension of the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement recommending the specific AE information that investigators should report , there is little evidence that analgesic RCTs adequately adhere to these recommendations . This systematic review builds on prior recommendations by describing a comprehensive checklist for AE reporting developed to capture clinical ly important AE information . Using this checklist , we coded AE assessment methods and reporting in all 80 double‐blind RCTs of noninvasive pharmacologic treatments published in the European Journal of Pain , Journal of Pain , and PAIN ® from 2006 to 2011 . Across all trials , reports of AEs were frequently incomplete , inconsistent across trials , and , in some cases , missing . For example , > 40 % of trials failed to report any information on serious adverse events . Trials of participants with acute or chronic pain conditions and industry‐sponsored trials typically provided more and better‐ quality AE data than trials involving pain‐free volunteers or trials that were not industry sponsored . The results of this review suggest that improved AE reporting is needed in analgesic RCTs . We developed an ACTTION ( Analgesic , Anesthetic , and Addiction Clinical Trial Translations , Innovations , Opportunities , and Networks ) AE reporting checklist that is intended to assist investigators in thoroughly and consistently capturing and reporting these critically important data in publications 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 Postoperative pain can have a significant effect on patient recovery . An underst and ing of patient attitudes and concerns about postoperative pain is important for identifying ways health care professionals can improve postoperative care . To assess patients ’ postoperative pain experience and the status of acute pain management , we conducted a national study by using telephone question naires . A r and om sample of 250 adults who had undergone surgical procedures recently in the United States was obtained from National Family Opinion . Patients were asked about the severity of postsurgical pain , treatment , satisfaction with pain medication , patient education , and perceptions about postoperative pain and pain medications . Approximately 80 % of patients experienced acute pain after surgery . Of these patients , 86 % had moderate , severe , or extreme pain , with more patients experiencing pain after discharge than before discharge . Experiencing postoperative pain was the most common concern ( 59 % ) of patients . Almost 25 % of patients who received pain medications experienced adverse effects ; however , almost 90 % of them were satisfied with their pain medications . Approximately two thirds of patients reported that a health care professional talked with them about their pain . Despite an increased focus on pain management programs and the development of new st and ards for pain management , many patients continue to experience intense pain after surgery . Additional efforts are required to improve patients ’ postoperative pain experience OBJECTIVE To assess how information about adverse events is included in systematic review s. STUDY DESIGN AND SETTING We included all new Cochrane review s published in the Cochrane Data base of Systematic Review s ( CDSRs ) and all new review s ( 2003 - -2004 ) in the Data base of Abstract s of Review s of Effects ( DAREs ) in Issue 1 2005 of The Cochrane Library . RESULTS More than half of Cochrane ( 44/78 ) and DARE ( 46/79 ) review s assessed drug interventions . The rest assessed surgery ( Cochrane [ 12 ] ; DARE [ 10 ] ) , psychosocial , educational , or physiotherapy interventions ( 22 ; 23 ) . Seventy-six percent ( 59/78 ) of Cochrane review s mentioned adverse events as an outcome compared with 48 % ( 38/79 ) of DARE review s. Most review s mentioning adverse events were of drug interventions ( Cochrane [ 41/59 ] ; DARE review s [ 29/38 ] ) . Considering review s that mentioned adverse events , 95 % ( 56/59 ) of Cochrane review s included only r and omized trials and 73 % ( 43/59 ) included an analysis of adverse events . For 10 Cochrane review s , adverse events had not been reported by the included trials . In contrast , 58 % ( 22/38 ) of DARE review s mentioning adverse events included only r and omized trials , the rest included both r and omized and nonr and omized studies . CONCLUSIONS Most Cochrane review s of drug interventions considered adverse events . This was not the case for DARE review s and for Cochrane review s of nondrug interventions . This could be improved The nocebo effect is the onset of untoward reactions following the administration of an indifferent substance . The oral challenge with alternative drugs plays a central role in the management of drug allergy and the use of inert substances is part of this procedure . We evaluated the occurrence and clinical characteristics of nocebo effect in patients with adverse drug reactions . Six hundred patients , seen in three different centres ( Genoa , Naples and Verona ) with a history of reactions to drugs , underwent a blind oral challenge with the administration of an indifferent substance and active drugs . The administration of an inert substance provoked untoward reactions in 54 patients ( 27 % ) in Verona , 60 ( 30 % ) in Naples and 48 ( 24 % ) in Genoa . The overall occurrence of nocebo effect was 27 % . The majority of reactions were subjective symptoms ( itching , malaise , headache etc ) , perceived as troublesome by all subjects . The occurrence was significantly higher in women than in men . Our data , collected in a large population , confirm that the nocebo effect occurs frequently in clinical practice . In managing adverse drug reactions through oral challenge the nocebo effect is m and atory to recognize false positive responses Objectives To compare the efficacy and safety of single versus combination non-prescription oral analgesics in community-derived people aged 40 years and older with chronic knee pain . Methods A r and omised , double-blind , four-arm , parallel-group , active controlled trial investigating short-term ( day 10 ) and long-term ( week 13 ) benefits and side-effects of four regimens , each taken three times a day : ibuprofen ( 400 mg ) ; paracetamol ( 1000 mg ) ; one fixed-dose combination tablet ( ibuprofen 200 mg/paracetamol 500 mg ) ; two fixed-dose combination tablets ( ibuprofen 400 mg/paracetamol 1000 mg ) . Results There were 892 participants ( mean age 60.6 , range 40–84 years ) ; 63 % had radiographic knee osteoarthritis and 85 % fulfilled American College of Rheumatology criteria for osteoarthritis . At day 10 , two combination tablets were superior to paracetamol ( p<0.01 ) for pain relief ( determined by mean change from baseline in WOMAC pain ; n=786 ) . At 13 weeks , significantly more participants taking one or two combination tablets rated their treatment as excellent/good compared with paracetamol ( p=0.015 , p=0.0002 , respectively ; n=615 ) . The frequency of adverse events was comparable between groups . However , by 13 weeks , decreases in haemoglobin ( ≥1 g/dl ) were observed in some participants in all groups . Twice as many participants taking two combination tablets had this decrease compared with those on monotherapy ( p<0.001 ; paracetamol , 20.3 % ; ibuprofen , 19.6 % ; one or two combination tablets , 24.1 % , 38.4 % , respectively ) . Conclusions Ibuprofen/paracetamol combination analgesia , at non-prescription doses , confers modest short-term benefits for knee pain/osteoarthritis . However , in this population , paracetamol 3 g/day may cause similar degrees of blood loss as ibuprofen 1200 mg/day , and the combination of the two appears to be additive . Study no IS RCT CONTEXT R and omized trials with adequate sample size offer an opportunity to assess the safety of new medications in a controlled setting ; however , generalizable data on drug safety reporting are sparse . OBJECTIVE To scrutinize the completeness of safety reporting in r and omized trials . DESIGN , SETTING , AND PATIENTS Survey of safety reporting in 192 r and omized drug trials 7 diverse topics with sample sizes of at least 100 patients and at least 50 patients in a study arm ( N = 130074 patients ) . Trial reports were identified from comprehensive meta-analyses in 7 medical areas . MAIN OUTCOME MEASURES Adequate reporting of specific adverse effects and frequency and reasons for withdrawals due to toxic effects ; article space allocated to safety reporting and predictors of such reporting . RESULTS Severity of clinical adverse effects and laboratory-determined toxicity was adequately defined in only 39 % and 29 % of trial reports , respectively . Only 46 % of trials stated the frequency of specific reasons for discontinuation of study treatment due to toxicity . For these 3 parameters , there was significant heterogeneity in rates of adequate reporting across topics ( P = .003 , P<.001 , and P = .02 , respectively ) . Overall , the median space allocated to safety results was 0.3 page . A similar amount of space was devoted to contributor names and affiliations ( P = .16 ) . On average , the percentage of space devoted to safety in the results section was 9.3 % larger in trials involving dose comparisons than in those that did not ( P<.001 ) and 3.8 % smaller in trials reporting statistically significant results for efficacy outcomes ( P = .047 ) . CONCLUSIONS The quality and quantity of safety reporting vary across medical areas , study design s , and setting s but they are largely inadequate . Current st and ards for safety reporting in r and omized trials should be revised to address this inadequacy Background Although the methods for conducting systematic review s of efficacy are well established , there is much less guidance on how systematic review s of adverse effects should be performed . Methods In order to determine where method ological research is most needed to improve systematic review s of adverse effects of health care interventions , we conducted a descriptive analysis of systematic review s published between 1994 and 2005 . We search ed the Data base of Abstract s of Review s of Effects ( DARE ) and The Cochrane Data base of Systematic Review s ( CDSR ) to identify systematic review s in which the primary outcome was an adverse effect or effects . We then extracted data on many of the elements of the systematic review process including : types of interventions studied , adverse effects of interest , re sources search ed , search strategies , data sources included in review s , quality assessment of primary data , nature of the data analysis , and source of funding . Results 256 review s were included in our analysis , of which the majority evaluated drug interventions and pre-specified the adverse effect or effects of interest . A median of 3 re sources were search ed for each review and very few review s ( 13/256 ) provided sufficient information to reproduce their search strategies . Although more than three quarters ( 185/243 ) of the review s sought to include data from sources other than r and omised controlled trials , fewer than half ( 106/256 ) assessed the quality of the studies that were included . Data were pooled quantitatively in most
Output:
| For aspirin 1000 mg and diflunisal 1000 mg , opioids , or fixed-dose combination drugs containing opioids , participants typically experienced significantly more adverse events than with placebo .
Studies of combinations of ibuprofen and paracetamol reported significantly fewer adverse events .
Serious adverse events were rare , occurring a rate of about 1 in 3200 participants .Most review s did not report specific adverse events .
AUTHORS ' CONCLUSIONS Despite ongoing problems with the measurement , recording , and reporting of adverse events in clinical trials and in systematic review s , the large amount of information available for single oral doses of analgesics provides evidence that adverse events rates are generally similar with active drug and placebo in these circumstances , except at higher doses of some drugs , and in combinations including opioids |
MS211866 | ***TASK*** the task is to summarize an input biomedical literature 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 : Sensory assessment to estimate spread and effectiveness of a peripheral nerve block is difficult because no clinical test is specific for small sensory fibers . Occurrence of a swelling illusion ( SI ) during a peripheral nerve block corresponds to the impairment of small sensory fibers . The authors investigated the usefulness of SI in predicting successful peripheral nerve block by assessing the temporospatial correlation between progression of sensory impairment in cutaneous distributions anesthetized and localization of SI during peripheral nerve block installation . Methods : Interscalene , infracoracoid , or sciatic nerve blocks were performed using a nerve stimulator and 1.5 % mepivacaine in 53 patients , with a total of 201 nerves to be anesthetized . Pinprick , cold , warm , touch , and proprioception were assessed every 3 min , while patients were asked to describe their perception of size and shape of their anesthetized limb and localization of these illusions . Data are presented as mean ± SD and percentage ( 95 % confidence interval ) . Results : Failure occurred in 12 cutaneous distributions out of a total of 201 theoretically blocked nerves . SI appeared earlier than warmth impairment ( 4.3 ± 2.7 vs. 6.2 ± 2.0 min ; P < 0.05 ) , always corresponding to successfully anesthetized cutaneous distributions , with the exception of 1 patient , who developed SI in 2 cutaneous distributions while sensory testing indicated failure in 1 distribution . SI successfully predicted the blockade of a cutaneous distribution with a sensitivity of 1.00 ( 0.98–1.00 ) , a specificity of 0.92 ( 0.65–0.99 ) , and an accuracy of 0.99 ( 0.97–1.00 ) . Conclusions : Swelling illusion may provide an early assessment of the success of a peripheral nerve block in unse date d patients Objective : To characterize the nature of sensory impairments after stroke , identify associated factors , and assess the relationships between sensory impairment , disability , and recovery . Methods : Prospect i ve cross-sectional survey of 102 people with hemiparesis following their first stroke . Tactile and proprioceptive sensation in the affected arm and leg were measured using the Rivermead Assessment of Somatosensory Perception 2 - 4 weeks post-stroke . Demographics , stroke pathology , weakness , neglect , disability , and recovery were documented . Results : Tactile impairment was more common than proprioceptive ( P < .000 ) , impairment of discrimination was more common than detection ( P < .000 ) , and tactile sensation was more severely impaired in the leg than the arm ( P < .000 ) . No difference in proprioception between the arm and leg ( P = .703 ) or between proximal and distal joints ( P = .589 , P = .705 ) was found . The degree of weakness and the degree of stroke severity were significantly associated with sensory impairment ; demographics , stroke side and type , and neglect were not associated . All the sensory modalities were significantly related to independence , mobility , and recovery ( r = 0.287 [ P < .011 ] to r = 0.533 [ P < .000 ] ) . Conclusion : Sensory impairments of all modalities are common after stroke , although tactile impairment is more frequent than proprioceptive loss , especially in the leg . They are associated with the degree of weakness and the degree of stroke severity but not demographics , stroke pathology , or neglect , and they are related to mobility , independence in activities of daily living , and recovery The role of proprioception as a protective mechanism has gained interest in recent years . From the clinical st and point , several studies have dealt with ways to enhance proprioception following surgery and during rehabilitation . If kinesthesia ( ability to detect passive motion ) can be enhanced as a consequence of long-term athletic training , such training must be included as a part of the rehabilitation process to protect the patient from reinjury . Consequently , the purpose of this study was to compare the kinesthetic knee pattern between trained gymnasts and healthy nongymnasts . The proprioception testing device ( PTD ) was used to evaluate knee kinesthesia . From 45 ° of flexion , the knee was passively extended with the PTD . The device was stopped by the subject when this passive motion was detected . Fifteen healthy college-age female gymnasts ( mean age 19.3 years ) and 30 normal volunteers ( mean age 20.7 years ) comprised our study sample . A one-way analysis of variance ( ANOVA ) was used to compare the mean values of the dominant gymnastic knee to the dominant knee in the control group . Results revealed statistically significant mean differences between the trained gymnastic group and the untrained control group ( F1.34 (.95)=7.17.P=0.011 ) . The results of this study suggest that extensive training has a positive influence on knee kinesthesia in addition to increasing muscle tone . According to the findings of this and other studies , highly trained athletes possess enhanced neurosensory pathways which are speculated to develop as a result of long-term athletic training . Although definite conclusions can not be made from our investigation , prospect i ve studies can determine the true role of athletic training in proprioceptive patterns The effect of glenohumeral arthritis and subsequent total shoulder arthroplasty ( TSA ) on shoulder proprioception has not been evaluated previously . A prospect i ve analysis of 20 consecutive patients with unilateral advanced glenohumeral arthritis who underwent TSA was undertaken . Shoulder proprioception testing for passive position sense and detection of motion was performed 1 week before surgery and 6 months after TSA . The presence of glenohumeral arthritis had a significant effect on position sense for all 3 planes tested ( flexion , abduction , and external rotation ) . There were significant differences ( P < .05 ) compared with the uninvolved shoulder and with a group of 20 age- and gender-matched subjects without a history of shoulder problems . Six months after TSA , position sense was significantly improved ( P < .05 ) and was not significantly different from that in the contralateral shoulder or the comparison group . Detection of motion was also significantly worse in the arthritic group compared with that in the uninvolved contralateral side ( P < .05 ) . Six months after TSA , the sensitivity to detection of motion improved ( P < .01 ) and was not significantly different than that in the uninvolved contralateral shoulder . In addition , the postoperative values for the involved shoulder were not significantly different than those in the age- and gender-matched comparison group . This study demonstrates a significant decrease in proprioceptive function in patients with advanced glenohumeral arthritis . After TSA , there was a marked improvement in proprioception STUDY DESIGN A cross-sectional study in patients with recurrent/chronic low back trouble and healthy control subjects . OBJECTIVE To evaluate the effect of paraspinal muscle fatigue on the ability to sense a change in lumbar position . SUMMARY OF BACKGROUND DATA Protection against spinal injury requires proper anticipation of events , appropriate sensation of body position , and reasonable muscular responses . Lumbar fatigue is known to delay lumbar muscle responses to sudden loads . It is not known whether the delay is because of failure in the sensation of position , output of the response , or both . METHODS Altogether , 106 subjects ( 57 patients with low back trouble [ 27 men and 30 women ] and 49 healthy control subjects [ 28 men and 21 women ] ) participated in the study . Their ability to sense a change in lumbar position while seated on a special trunk rotation unit was assessed . A motor rotated the seat with an angular velocity of 1 degree per second . The task in the test involved reacting to the perception of lumbar movement ( rotation ) by releasing a button with a finger movement . The test was performed twice , before and immediately after a fatiguing procedure . During the endurance task , the participants performed upper trunk repetitive extensions against a resistance , with a movement amplitude adjusted between 25 degrees flexion and 5 degrees extension , until exhaustion . RESULTS Patients with chronic low back trouble had significantly poorer ability than control subjects on the average to sense a change in lumbar position ( P = 0.007 ) , which was noticed before and after the fatiguing procedure . Lumbar fatigue induced significant impairment in the sensation of position change ( P < 0.000001 ) . CONCLUSIONS Lumbar fatigue impairs the ability to sense a change in lumbar position . This feature was found in patients and control subjects , but patients with low back trouble had poorer ability to sense a change in lumbar position than control subjects even when they were not fatigued . There seems to be a period after a fatiguing task during which the available information on lumbar position and its changes is inaccurate Study Design . A clinical trial comparing a back pain group with a pain‐free group . Objectives . To investigate whether proprioceptive deficits existed in a group of individuals reporting low back pain . Summary of Background Data . Little work has so far been conducted on the measurement of proprioception in the spine . Those studies that have been carried out , however , have failed to identify proprioceptive deficits in individuals with back pain . Previous work on peripheral joints has revealed that proprioception is affected with muscular or joint injury or degeneration . Methods . Forty individuals took part in the study , 20 with back pain and 20 with no pain . Participants were required to reproduce a predetermined target position , in st and ing and four‐point kneeling , 10 times in 30 seconds . A computer screen was used to provide visual feedback on position . A mean deviation from the target position was obtained for each individual . A measurement of left elbow position sense was conducted in five individuals from each group to establish differences in short‐term motor memory between the groups . Results . There were no differences between the subject groups in terms of short‐term motor memory ( P > 0.05 ) . A two‐way analysis of variance between subject groups and position to identify differences in accuracy ( deviation from the target ) found that there were differences between subject groups in either position ( P < 0.05 ) . There was no significant difference in accuracy between the positions used ( P > 0.05 ) . Conclusions . Differences in proprioception do exist between individuals with back pain and those free from back pain . Further research needs to be undertaken on proprioceptive exercise programs and their effect on back pain Objective : To develop a st and ardized , clinical ly relevant , quantitative assessment of somatosensory performance in patients with stroke . Design : Prospect i ve observational study and test evaluation . Setting : Local Oxford hospitals and a regional neurological rehabilitation centre . Subjects : Stroke patients with a ” rst , lateralized acute stroke in hospital , and age-matched control subjects . Method : Each patient was assessed in a structured way using a new battery of formal tests of somatosensory performance . Results : A total of 100 patients and 50 controls were fully investigated . Control subjects performed at or near ceiling on all tests , but patients showed impaired performance on all tests . The Rivermead Assessment of Somatosensory Performance ( RASP ) showed good intra-rater and inter-rater reliability for all subtests . There were however only weak relationships between scores of sensory impairment and scores of motor impairment or mobility and dependence . Conclusions : The RASP provides a practical and reliable assessment of sensory loss , which provides the clinician with a comprehensive picture of the patient ’s performance and can be used to inform and monitor rehabilitation and recovery OBJECTIVES To identify a battery of tests that predicts safe and unsafe performance on an on-road assessment of driving . DESIGN Prospect i ve cohort study . SETTING University laboratory assessment and an on-road driving test . PARTICIPANTS Two hundred seventy community-living adults aged 70 to 88 recruited through the electoral roll . MEASUREMENTS Performance on a battery of multidisciplinary tests and on a st and ardized measure of on-road driving performance . RESULTS A combination of three tests from the vision , cognitive , and motor domains , including motion sensitivity , color choice reaction time , postural sway on a compliant foam rubber surface , and a self-reported measure of driving exposure , was able to classify participants into safe and unsafe driver groups with sensitivity of 91 % and specificity of 70 % . CONCLUSION In a sample of licensed older drivers , a short battery of tests and a self-reported measure of driving exposure were able to accurately predict driving safety Background Female athletes are at significantly greater risk of anterior cruciate ligament ( ACL ) injury than male athletes in the same high-risk sports . Decreased trunk ( core ) neuromuscular control may compromise dynamic knee stability . Hypotheses ( 1 ) Increased trunk displacement after sudden force release would be associated with increased knee injury risk ; ( 2 ) coronal ( lateral ) , not sagittal , plane displacement would be the strongest predictor of knee ligament injury ; ( 3 ) logistic regression of factors related to core stability would accurately predict knee , ligament , and ACL injury risk ; and ( 4 ) the predictive value of these models would differ between genders . Study Design Cohort study ( prognosis ) ; Level of evidence , 2 . Methods In this study , 277 collegiate athletes ( 140 female and 137 male ) were prospect ively tested for trunk displacement after a sudden force release . Analysis of variance and multivariate logistic regression identified predictors of risk in athletes who sustained knee injury . Results Twenty-five athletes ( 11 female and 14 male ) sustained knee injuries over a 3-year period . Trunk displacement was greater in athletes with knee , ligament , and ACL injuries than in uninjured athletes ( P < .05 ) . Lateral displacement was the strongest predictor of ligament injury ( P = .009 ) . A logistic regression model , consisting of trunk displacements , proprioception , and history of low back pain , predicted knee ligament injury with 91 % sensitivity and 68 % specificity ( P = .001 ) . This model predicted knee , ligament , and ACL injury risk in female athletes with 84 % , 89 %
Output:
| There was wide variation in methods , the joints able to be tested , and the population s sample d. The predominant construct was active or passive joint position detection , followed by passive motion detection and motion direction discrimination .
The Rivermead Assessment of Somatosensory Perception was generally considered to be a valid and reliable tool but with low precision ; other tools with higher precision are potentially not clinical ly feasible . |
MS211867 | ***TASK*** the task is to summarize an input biomedical literature 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 : In epidemiological studies , weight loss is usually associated with increased mortality rate . Contrarily , among obese people , weight loss reduces other risk factors for disease and death . We hypothesised that this paradox could exist because weight is used as an implicit adiposity index . No study has considered the independent effects of weight loss and fat loss on mortality rate . We studied mortality rate as a function of weight loss and fat loss . DESIGN : Analysis of ‘ time to death ’ in two prospect i ve population -based cohort studies , the Tecumseh Community Health Study ( 1890 subjects ; 321 deaths within 16 y of follow-up ) and the Framingham Heart Study ( 2731 subjects ; 507 deaths within 8 y of follow-up ) , in which weight and fat ( via skinfolds ) loss were assessable . RESULTS : In both studies , regardless of the statistical approach , weight loss was associated with an increased , and fat loss with a decreased , mortality rate ( P<0.05 ) . Each st and ard deviation ( s.d . ) of weight loss ( 4.6 kg in Tecumseh , 6.7 kg in Framingham ) was estimated to increase the hazard rate by 29 % ( 95 % confidence interval CI ) , ( 14 % , 47 % , respectively ) and 39 % ( 95 % CI , 25 % , 54 % respectively ) , in the two sample s. Contrarily , each s.d . of fat loss ( 10.0 mm in Tecumseh , 4.8 mm in Framingham ) was estimated to reduce the hazard rate 15 % ( 95 % CI , 4 % , 25 % ) and 17 % ( 95 % CI , 8 % , 25 % ) in Tecumseh and Framingham , respectively . Generalisability of these results to severely ( that is , body mass index BMI ) ≥34 ) obese individuals is unclear . CONCLUSIONS : Among individuals that are not severely obese , weight loss is associated with increased mortality rate and fat loss with decreased mortality rate Binge eating disorder ( BED ) is associated with high levels of obesity and psychological suffering , but little is known about 1 ) the distribution of features of BED in the general population and 2 ) their consequences for weight development and psychological distress in young adulthood . We investigated the prevalence of features of BED and their association with body mass index ( BMI ) and psychological distress among men ( n = 2423 ) and women ( n = 2825 ) from the longitudinal community-based FinnTwin16 cohort ( born 1975 - 1979 ) . Seven eating-related cognitions and behaviors similar to the defining features of BED were extracted from the Eating Disorder Inventory-2 and were assessed at a mean age of 24 . BMI and psychological distress , measured with the General Health Question naire , were assessed at ages 24 and 34 . We assessed prevalence of the features and their association with BMI and psychological distress cross-sectionally and prospect ively . More than half of our participants reported at least one feature of BED ; clustering of several features in one individual was less common , particularly among men . The most frequently reported feature was ' stuffing oneself with food ' , whereas the least common was ' eating or drinking in secrecy ' . All individual features of BED and their clustering particularly were associated with higher BMI and more psychological distress cross-sectionally . Prospect ively , the clustering of features of BED predicted increase in psychological distress but not additional weight gain when baseline BMI was accounted for . In summary , although some features of BED were common , the clustering of several features in one individual was not . The features were cumulatively associated with BMI and psychological distress and predicted further increase in psychological distress over ten years of follow-up Aims : To compare effectiveness of a 1-year weight loss program in moderately and severely obese patients . Methods : The study sample included 311 obese patients participating in a weight loss program , which comprised a 12-week weight reduction phase ( low-calorie formula diet ) and a 40-week weight maintenance phase . Body weight and glucose and lipid values were determined at the beginning of the program as well as after the weight reduction and the weight maintenance phase . Participants were analyzed according to their BMI class at baseline ( 30 - 34.9 kg/m2 ; 35 - 39.9 kg/m2 ; 40 - 44.9 kg/m2 ; 45 - 49.9 kg/m2 ; ≥50 kg/m2 ) . Furthermore , moderately obese patients ( BMI < 40 kg/m2 ) were compared to severely obese participants ( BMI ≥ 40 kg/m2 ) . Results : Out of 311 participants , 217 individuals completed the program . Their mean baseline BMI was 41.8 ± 0.5 kg/m2 . Average weight loss was 17.9 ± 0.6 % , result ing in a BMI of 34.3 ± 0.4 kg/m2 after 1 year ( p < 0.001 ) . Overall weight loss was not significantly different in moderately and severely obese participants . Yet , severely obese participants achieved greater weight loss during the weight maintenance phase than moderately obese participants ( -3.1 ± 0.7 % vs. -1.2 ± 0.6 % ; p = 0.04 ) . Improvements in lipid profiles and glucose metabolism were found throughout all BMI classes . Conclusion : 1-year weight loss intervention improves body weight as well as lipid and glucose metabolism not only in moderately , but also in severely obese individuals Background Behavioral lifestyle interventions during pregnancy can prevent excessive gestational weight gain ( GWG ) in women with normal weight ; however , effective interventions to reduce GWG in ethnically diverse women with obesity are lacking . Objective A r and omized controlled trial was conducted to test whether a behavioral lifestyle intervention with partial meal replacement reduces GWG rate in Hispanic and non-Hispanic women with overweight or obesity relative to enhanced usual care . Design Participants ( n = 257 ) were recruited in San Luis Obispo , California , and Providence , Rhode Isl and , between November 2012 and May 2016 . Participants were pregnant ( mean ± SD : 13.6 ± 1.8 wk of gestation ) with overweight or obesity and had a mean age of 30.3 y ; 41.6 % of participants were Hispanic . Women were r and omly assigned within site and by ethnicity to enhanced usual care ( n = 128 ) or to a behavioral lifestyle intervention with partial meal replacement ( n = 129 ) . The primary outcome was GWG per week of observation . Secondary outcomes were proportions exceeding Institute of Medicine ( IOM ) guidelines for total GWG , changes in weight-control behaviors and cardiovascular disease risk factors , and incidence of pregnancy complications . Study retention was 99.6 % ( 256 of 257 ) . Results The intervention compared with usual care result ed in less mean ± SD weekly GWG ( 0.33 ± 0.25 compared with 0.39 ± 0.23 kg/wk ; P = 0.02 ) and total GWG ( 9.4 ± 6.9 compared with 11.2 ± 7.0 kg ; P = 0.03 ) and reduced the proportion of women who exceeded IOM guidelines for total GWG ( 41.1 % compared with 53.9 % ; P = 0.03 ) . No significant group × time × demographic subgroup ( ethnicity , BMI , age , parity , and income ) interactions were observed . Among intervention participants , greater meal replacement intake was related to reduced GWG rate ( β = -0.07 ; 95 % CI:-0.12 , -0.03 ; P = 0.002 ) . The intervention compared with usual care increased weight-control strategies ( P < 0.0001 ) and cognitive restraint ( P < 0.0001 ) and reduced triglycerides ( P = 0.03 ) . Conclusion Prenatal behavioral intervention with partial meal replacement significantly reduced GWG in Hispanic and non-Hispanic women with overweight or obesity . This trial was registered at www . clinical trials.gov as NCT01545934 Background We evaluated the effectiveness of a sequential diet regimen termed the obese preoperative diet ( OPOD ) in morbidly obese patients with and without type 2 diabetes mellitus ( T2DM ) scheduled for laparoscopic bariatric surgery . Methods Fifty patients ( body mass index 53.5 ± 8.4 kg/m2 ) scheduled for bariatric surgery , including 14 with T2DM , were prospect ively enrolled and followed the OPOD regimen : a very low-calorie ketogenic diet for 10 days , followed by a very low-calorie diet for 10 days , and then a low-calorie diet for 10 days . Patients were evaluated at baseline ( T0 ) and after 10 days ( T1 ) , 20 days ( T2 ) , and 30 days ( T3 ) . Results Body weight , body mass index , waist circumference , and neck circumference were significantly lower at T1 , T2 , and T3 than at T0 in the 48 patients who completed the OPOD . Two patients discontinued the OPOD after 4–7 days . In patients with T2DM , fasting plasma glucose levels decreased significantly , enabling reduction of diabetic medications . Plasma and urine ketone levels increased at T1 but were all < 1 mmol/L , and hunger decreased during the diet period . Conclusions OPOD , including 10 days of a VLCKD , was safe and effective in morbidly obese patients , and it seems to be promising in morbidly obese patients with and without T2DM scheduled for laparoscopic bariatric surgery Objective Attrition rates of up to 77 % have been reported in conservative weight-reduction programs for the treatment of obesity . In view of the cost of such programs to the health system , there is a need to identify the variables that predict premature discontinuation of treatment . Previous studies have focused mainly on somatic and sociodemographic parameters . The prospect i ve influence of psychological factors has not been systematic ally investigated to date . Methods A total of 164 patients ( 138 of whom were women ) with a mean age of 45 years and a mean body mass index of 39.57 participated in a 1-year outpatient weight-reduction program at the Charité – Universitätsmedizin Berlin University Hospital . The program included movement therapy , dietary advice , psychoeducational and behavioral interventions , relaxation procedures , and consultations with a specialist in internal medicine and a psychologist . Patients also underwent regular laboratory and psychological testing . The results were evaluated using a t-test , χ2-test , and logistic regression analysis . Results Seventy-one of the 164 patients ( 61 women , mean age = 43 years , mean body mass index = 39.53 ) withdrew before the end of the program ( attrition rate = 43.3 % ) . While there were no differences between the somatic and metabolic characteristics of those who withdrew and those who remained , the sociodemographic and psychological factors had some relevance . In particular , “ expectation of self-efficacy ” ( Fragebogen zu Selbstwirksamkeit , Optimismus und Pessimismus [ SWOP ] ) , “ not working , ” “ tiredness ” ( Berliner Stimmungsfragebogen [ BSF ] ) , “ pessimism ” ( SWOP ) and “ positive reframing ” ( Brief-COPE ) were found to play a role in whether participants subsequently dropped out of the treatment . “ Support coping ” ( Brief-COPE ) and “ older age ” prior to the start of treatment were identified as variables that promoted treatment adherence . Conclusion The results are discussed in light of previous findings and with regard to whether the modules of the weight-reduction program should be adapted 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 OBJECTIVE To estimate the effect of intentional weight loss on mortality in overweight individuals with diabetes . RESEARCH DESIGN AND METHODS We performed a prospect i ve analysis with a 12-year mortality follow-up ( 1959 - 1972 ) of 4,970 overweight individuals with diabetes , 40 - 64 years of age , who were enrolled in the American Cancer Society 's Cancer Prevention Study I. Rate ratios ( RRs ) were calculated , comparing overall death rates , and death from cardiovascular disease ( CVD ) or diabetes in individuals with and without reported intentional weight loss . RESULTS Intentional weight loss was reported by 34 % of the cohort . After adjustment for initial BMI , sociodemographic factors , health status , and physical activity , intentional weight loss was associated with a 25 % reduction in total mortality ( RR = 0.75 ; 95 % CI 0.67 - 0.84 ) , and a 28 % reduction in CVD and diabetes mortality ( RR = 0.72 ; 0.63 - 0.82 ) . Intentional weight loss of 20 - 29 lb was associated with the largest
Output:
| While the included publications had a moderate risk of bias score , which may inflate reported weight loss outcomes , the published data to date suggest that severely energy-restricted diets , delivered via diets of varying composition , effectively produce clinical ly relevant weight loss ( ≥10 % of initial body weight ) when used for 6 weeks or more in people with class III obesity |
MS211868 | ***TASK*** the task is to summarize an input biomedical literature 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: High-dose immunosuppressive therapy ( HDIT ) with autologous hematopoietic stem cell transplantation ( auto-HSCT ) is a new and promising approach to the treatment of multiple sclerosis ( MS ) patients because currently there are no effective treatment methods for this disease . In this article , we present results of a prospect i ve clinical study of efficacy of HDIT + auto-HSCT in MS patients . The following treatment strategies were employed in the study : " early , " " conventional , " and " salvage/late " transplantation . Fifty patients with various types of MS were included in this study . No toxic deaths were reported among 50 MS patients ; transplantation procedure was well-tolerated by the patients . The efficacy analysis was performed in 45 patients . Twenty-eight patients achieved an objective improvement of neurological symptoms , defined as at least 0.5-point decrease in the Exp and ed Disability Status Scale ( EDSS ) score as compared to the baseline and confirmed during 6 months , and 17 patients had disease stabilization ( steady EDSS level as compared to the baseline and confirmed during 6 months ) . The progression-free survival at 6 years after HDIT + auto-HSCT was 72 % . Magnetic resonance imaging data were available in 37 patients before transplantation showing disease activity in 43.3 % . No active , new , or enlarging lesions were registered in patients without disease progression . In conclusion , HDIT + auto-HSCT suggests positive results in management of patients with different types of MS . Identification of treatment strategies based on the level of disability , namely " early , " " conventional , " and " salvage/late " transplantation , appears to be feasible to improve treatment outcomes Based on the good results of experimental transplantation in animal models of multiple sclerosis and of other autoimmune diseases , we have treated 24 patients suffering from chronic progressive multiple sclerosis with high-dose chemotherapy ( BEAM regimen ) followed by autologous blood stem cell rescue and antithymocyte globulin . Blood stem cells were mobilised with cyclophosphamide at 4g/m2 and G- ( or GM- ) CSF . In 9 cases , additional CD34 + cell- selection of the graft was performed . Here we up date previously published results of this novel treatment , mainly with regard to clinical efficacy , as the median follow-up time has reached 40 months ( range , 21–51 ) . Infections were the principal toxicity early after the procedure , with death of a patient from aspergillosis 65 days post stem cell infusion . No serious late events occurred apart from a case of autoimmune thyroiditis that developed 11 months after transplant in a patient who had received a CD34 + cell-depleted graft . Mild and transient neurotoxicity was observed in 10 patients ( 42 % ) , most probably associated with fever and infections . Eighteen patients ( 18/23 ; 78 % ) responded to the treatment , i.e. , they were improved or stabilized , while five patients progressed , of which 4 had primary progressive disease . Of those improved or stabilised ( 18 ) , 9 patients have maintained stable condition whereas 9 developed relapses or they slowly resumed progression , although their disability scores have not gotten worse than they were before transplantation . The probability of progression-free survival ( compared to entry status ) at 3 years is 92 % for patients with secondary progressive disease and 39 % for the primary progressive type . CD34 + cell- selection did not seem to yield better results except for a delay in progression or in relapse after transplantation . These results appear better than those achieved by any other treatment of progressive multiple sclerosis , including beta-interferon , but they need to be confirmed by other open or controlled studies in view of the well-known difficulty of judging objective ly the effect of a treatment in patients with this disease There were 26 patients enrolled in a pilot study of high-dose immunosuppressive therapy ( HDIT ) for severe multiple sclerosis ( MS ) . Median baseline exp and ed disability status scale ( EDSS ) was 7.0 ( range , 5.0 - 8.0 ) . HDIT consisted of total body irradiation , cyclophosphamide , and antithymocyte globulin ( ATG ) and was followed by transplantation of autologous , granulocyte colony-stimulating factor (G-CSF)-mobilized CD34-selected stem cells . Regimen-related toxicities were mild . Because of bladder dysfunction , there were 8 infectious events of the lower urinary tract . One patient died from Epstein-Barr virus (EBV)-related posttransplantation lymphoproliferative disorder ( PTLD ) associated with a change from horse-derived to rabbit-derived ATG in the HDIT regimen . An engraftment syndrome characterized by noninfectious fever with or without rash developed in 13 of the first 18 patients and was associated in some cases with transient worsening of neurologic symptoms . There were 2 significant adverse neurologic events that occurred , including a flare of MS during mobilization and an episode of irreversible neurologic deterioration after HDIT associated with fever . With a median follow-up of 24 ( range , 3 - 36 ) months , the Kaplan-Meier estimate of progression ( > /= 1.0 point EDSS ) at 3 years was 27 % . Of 12 patients who had oligoclonal b and s in the cerebrospinal fluid at baseline , 9 had persistence after HDIT . After HDIT , 4 patients developed new enhancing lesions on magnetic resonance imaging of the brain . The estimate of survival at 3 years was 91 % . Important clinical issues in the use of HDIT and stem cell transplantation for MS were identified ; however , modifications of the initial approaches appear to reduce treatment risks . This was a heterogeneous high-risk group , and a phase 3 study is planned to fully assess efficacy Aggressive forms of multiple sclerosis ( MS ) represent a limited group of demyelinating diseases that rapidly progress to severe disability . Currently available therapies are poorly effective against these clinical entities . Recently , it has been demonstrated that intense immunosuppression followed by autologous haematopoietic stem cell transplantation ( AHSCT ) can affect the clinical course of individuals with severe MS and completely abrogate the inflammatory activity detected by MRI . We report the result of the Italian phase 2 GITMO study , a multicentre study in which 21 MS patients , who were rapidly deteriorating and not responding to the usual therapeutic strategies , were treated with this procedure . The clinical effect of the treatment is long lasting , with a striking abrogation of inflammation detected by MRI findings . These results support a role for intense immunosuppression followed by ASCT as treatment in rapidly evolving MS cases unresponsive to conventional therapies There were 21 patients with rapidly progressive multiple sclerosis ( MS ) treated on a phase 1/2 study of intense immune suppressive therapy and autologous hematopoietic stem cell ( HSC ) support with no 1-year mortality . Following transplantation , one patient had a confirmed acute attack of MS . Neurologic progression defined by the exp and ed disability status scale ( EDSS ) did not increase in disability by 1.0 or more steps in any of 9 patients with a pretransplantation EDSS of 6.0 or less . In 8 of 12 patients with high pretransplantation disability scores ( EDSS > 6.0 ) , progressive neurologic disability as defined by at least a 1-point increase in the EDSS has occurred and was manifested as gradual neurologic deterioration . There were 2 patients with a pretransplantation EDSS of 7.0 and 8.0 who died from complications of progressive disease at 13 and 18 months following treatment . Our experience suggests that intense immune suppression using a total body irradiation (TBI)-based regimen and hematopoietic stem cell transplantation ( HSCT ) are not effective for patients with progressive disease and high pretransplantation disability scores . Further studies are necessary to determine the role of intense immune suppressive therapy and HSC support in ambulatory patients with less accumulated disability and more inflammatory disease activity . Specifically , more patients and longer follow-up would be required in patients with an EDSS of 6.0 or less before drawing conclusions on this subgroup RATIONALE Phase I/II studies of autologous hematopoietic stem cell transplantation ( HSCT ) for multiple sclerosis ( MS ) were initiated , based on results of experimental transplantation in animal models of multiple sclerosis and clinical observations in patients treated concomitantly for malignant disease . PATIENTS Eighty-five patients with progressive MS were treated with autologous HSCT in 20 centers and reported to the autoimmune disease working party of the European Group for Blood and Marrow Transplantation ( EBMT ) . 52 ( 61 % ) were female , median age was 39 [ 20 - 58 ] years . The median interval from diagnosis to transplant was 7 [ 1 - 26 ] years . Patients suffered from severe disease with a median EDSS score of 6.5 [ 4.5 - 8.5 ] . Active disease prior to transplant was documented in 79 of 82 evaluable cases . RESULTS The stem cell source was bone marrow in 6 and peripheral blood in 79 , and stem cells were mobilized into peripheral blood using either cyclophosphamide combined with growth factors or growth factors alone . Three patients experienced transient neurological complications during the mobilization phase . The high dose regimen included combination chemotherapy , with or without anti-lymphocyte antibodies or , with or without , total body irradiation . The stem cell transplants were purged of lymphocytes in 52 patients . Median follow-up was 16 [ 3 - 59 ] months . There were 7 deaths , 5 due to toxicity and infectious complications , 2 with neurological deterioration . The risk of death of any cause at 3 years was 10 (+/-7)% ( 95 % confidence interval ) . Neurological deterioration during transplant was observed in 22 patients ; this was transient in most but was associated with MS progression in 6 patients . Neurological improvement by > or = 1 point in the EDSS score was seen in 18 ( 21 % ) patients . Confirmed progression-free survival was 74 (+/-12)% at 3 years being 66 (+/-23)% in patients with primary progressive MS but higher in patients with secondary progressive or relapsing-remitting MS , 78 (+/-13)% ; p = 0.59 . The probability of confirmed disease progression was 20 (+/-11)% . MRI data were available in 78 patients before transplant showing disease activity ( gadolinium enhancing , new or enlarging lesions ) in 33 % . Posttransplant MRI showed activity at any time in 5/61 ( 8 % ) evaluable cases . CONCLUSION Autologous HSCT suggest positive early results in the management of progressive MS and is feasible . These multicentre data suggest an association with significant mortality risks especially in some patient groups and are being utilised in the planning of future trials to reduce transplant related mortality AUTOIMMUNE DISEASES ( AD ) have a high prevalence and cause significant morbidity , health care expense , and mortality . The treatment of certain patients suffering from severe AD , refractory to conventional therapies , is unsatisfactory . Theoretical considerations , pre clinical animal models , and recently published clinical experience support the concept that the natural course of AD may be altered by intensive immunoablation and autologous stem cell transplantation ( ASCT ) . Eradication of autoreactive cells by the conditioning regimen and redistribution of an altered cellular and humoral immunological network , or thymic reeducation , are potential mechanisms for response . On this basis , ASCT is a promising experimental therapy for AD resistant to conventional treatments . We report the preliminary results of the Spanish experience in this field BACKGROUND AND OBJECTIVES Autologous stem cell transplantation ( ASCT ) is currently being evaluated as a therapy for patients with multiple sclerosis ( MS ) . We report the results of a phase II trial to evaluate feasibility and toxicity of CD34 + selected ASCT ( CD34+/ASCT ) and treatment results at one year of follow-up . DESIGN AND METHODS Patients with advanced secondary progressive ( SP ) or relapsing-remitting ( RR ) MS and confirmed worsening of the extended disability status scale ( EDSS ) in the previous year despite interferon or other immunotherapies were included . Peripheral blood stem cells were obtained by leukaphereses after mobilization with cyclophosphamide ( Cy ) and granulocyte colony-stimulating factor ( G-CSF ) . CD34 + selection was performed by means of an Isolex 300 or CliniMACS device . BCNU , Cy and antithymocyte globulin ( ATG ) were administered as conditioning regimen . RESULTS Fifteen patients ( 9 SPMS and 6 RRMS ) with a median EDSS of 6.0 ( 4.5 - 6.5 ) and a median of 3 ( 1 - 7 ) relapses in the previous year were included . Mobilization was unsuccessful in one patient . During mobilization , one patient had a transient neurologic deterioration . The main complication during ASCT were engraftment syndrome , which developed in three patients , CMV reactivation in one , and neurologic deterioration in two patients coinciding with high-fever related to ATG . Hematologic recovery was fast and complete in all cases . At 12 months , the EDSS had improved in three patients , worsened in two and remained stable in nine . Despite withdrawal of all immunosuppressive therapy only two patients had relapses . Magnetic resonance imaging showed disappearance of enhanced T1 lesions but oligoclonal b and s persisted in the cerebrospinal fluid of all evaluated cases . INTERPRETATION AND CONCLUSIONS CD34
Output:
| Results : For secondary progressive MS , immunoablative therapy with autologous bone marrow/peripheral blood stem cell transplantation was associated with higher progression-free survival ( up to 3 years following treatment ) when using intermediate-intensity conditioning regimens compared with high-intensity conditioning regimens .
Conclusions : Patients with secondary progressive MS refractory to conventional medical treatment have longer progression-free survival following autologous stem cell transplantation with intermediate-intensity conditioning regimens than with high-intensity conditioning regimens |
MS211869 | ***TASK*** the task is to summarize an input biomedical literature 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 prospect i ve , open-label study evaluated the efficacy and safety of adjunctive levetiracetam ( LEV ) in Korean adults with uncontrolled partial epilepsy . Study patients had to have an average of at least 1 and not more than 14 partial seizures per month ( averaged over a 3-month historical baseline ) despite the use of one or two AEDs . Patients initially received LEV 1000 mg/day ( administered bid ) and could increase to 2000 mg/day after 2 weeks , and to 3000 mg/day after another 2 weeks , to obtain adequate seizure control . During the 12-week maintenance period , the dose of LEV could be increased or decreased once if seizure control was insufficient or tolerability warranted , respectively . Seizure count and adverse events ( AEs ) were recorded by patients . Global evaluation scale ( GES ) and quality of life ( QOLIE-31 ) were also evaluated . A total of 100 patients were enrolled and 92 patients completed the study . The median percent reduction in weekly seizure frequency over the treatment period was 43.2 % . The > or=50 % and > or=75 % responder rates were 45.4 % and 36.1 % , respectively . Seizure freedom throughout the 16-week treatment period was observed in 17 patients . On investigator 's GES , 81 patients were considered improved , with 41 patients showing marked improvement . Most QOLIE-31 scales improved significantly . Treatment-emergent AEs were reported in 59 patients . Three most common AEs were somnolence ( 36 % ) , dizziness ( 12 % ) , and headache ( 8 % ) . Adjunctive LEV therapy was effective and well-tolerated in Korean adults with refractory partial epilepsy CONTEXT Despite reported success , surgery for pharmacoresistant seizures is often seen as a last resort . Patients are typically referred for surgery after 20 years of seizures , often too late to avoid significant disability and premature death . OBJECTIVE We sought to determine whether surgery soon after failure of 2 antiepileptic drug ( AED ) trials is superior to continued medical management in controlling seizures and improving quality of life ( QOL ) . DESIGN , SETTING , AND PARTICIPANTS The Early R and omized Surgical Epilepsy Trial ( ERSET ) is a multicenter , controlled , parallel-group clinical trial performed at 16 US epilepsy surgery centers . The 38 participants ( 18 men and 20 women ; aged ≥12 years ) had mesial temporal lobe epilepsy ( MTLE ) and disabling seizues for no more than 2 consecutive years following adequate trials of 2 br and -name AEDs . Eligibility for anteromesial temporal resection ( AMTR ) was based on a st and ardized presurgical evaluation protocol . Participants were r and omized to continued AED treatment or AMTR 2003 - 2007 , and observed for 2 years . Planned enrollment was 200 , but the trial was halted prematurely due to slow accrual . INTERVENTION Receipt of continued AED treatment ( n = 23 ) or a st and ardized AMTR plus AED treatment ( n = 15 ) . In the medical group , 7 participants underwent AMTR prior to the end of follow-up and 1 participant in the surgical group never received surgery . MAIN OUTCOME MEASURES The primary outcome variable was freedom from disabling seizures during year 2 of follow-up . Secondary outcome variables were health-related QOL ( measured primarily by the 2-year change in the Quality of Life in Epilepsy 89 [ QOLIE-89 ] overall T-score ) , cognitive function , and social adaptation . RESULTS Zero of 23 participants in the medical group and 11 of 15 in the surgical group were seizure free during year 2 of follow-up ( odds ratio = ∞ ; 95 % CI , 11.8 to ∞ ; P < .001 ) . In an intention-to-treat analysis , the mean improvement in QOLIE-89 overall T-score was higher in the surgical group than in the medical group but this difference was not statistically significant ( 12.6 vs 4.0 points ; treatment effect = 8.5 ; 95 % CI , -1.0 to 18.1 ; P = .08 ) . When data obtained after surgery from participants in the medical group were excluded , the effect of surgery on QOL was significant ( 12.8 vs 2.8 points ; treatment effect = 9.9 ; 95 % CI , 2.2 to 17.7 ; P = .01 ) . Memory decline ( assessed using the Rey Auditory Verbal Learning Test ) occurred in 4 participants ( 36 % ) after surgery , consistent with rates seen in the literature ; but the sample was too small to permit definitive conclusions about treatment group differences in cognitive outcomes . Adverse events included a transient neurologic deficit attributed to a magnetic resonance imaging-identified postoperative stroke in a participant who had surgery and 3 cases of status epilepticus in the medical group . CONCLUSIONS Among patients with newly intractable disabling MTLE , resective surgery plus AED treatment result ed in a lower probability of seizures during year 2 of follow-up than continued AED treatment alone . Given the premature termination of the trial , the results should be interpreted with appropriate caution . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00040326 The objective of this study was to compare the relative cost-effectiveness of two AEDs by a prospect i ve clinical audit . Patients starting on the adjunctive therapies lamotrigine and topiramate were recruited from the out-patient epilepsy clinics at Queen Square . Three interview were scheduled : baseline ; three months follow-up and six months from baseline . Of the 81 patients recruited , a total of 73 patients completed all three interviews . An intention to treat analysis was performed on the data . Seizure severity and frequency were assessed using the National Hospital Seizure Severity Scale . Side-effects , adverse events and reasons for stopping medication were also recorded . At the third interview , a total of 47/73 ( 64 % ) were still on the prescribed adjunctive drug . Outcome was assessed by two methods : the > 50 % seizure reduction cited in the literature and a more stringent assessment of patient ' satisfaction ' which we defined operationally on clinical criteria . Using this definition , a total of 10/73 ( 14 % ) patients were ' satisfied ' . The relative costs of starting patients on each of the two AEDs were calculated , both drug costs and the costs of adverse events ( the latter were defined as events requiring urgent medical attention ) . The costs of the two drugs were compared . A number of method ological issues relating to cost comparison are discussed . Outcome and pharmaco-economic studies need to assess more than reduction in number of seizures . They should take into account variables important for quality of life including side-effects and adverse events PURPOSE In this prospect i ve study , we compared the long-term cognitive and behavioral effects of lamotrigine ( LTG ) and carbamazepine ( CBZ ) in patients with newly diagnosed or untreated partial epilepsy . METHODS This was a multicenter , open-label , r and omized study that compared monotherapy with LTG and CBZ in newly diagnosed or untreated patients with partial epilepsy . We employed an 8-week titration period and a 40-week maintenance period . Neuropsychological tests , Symptom Check List-90 , and QOLIE-31 were assessed at baseline , 16 weeks , and 48 weeks after drug treatment . A group-by-time interaction was the primary outcome measure and was analyzed by use of the linear mixed model . RESULTS A total of 110 patients were eligible and 73 completed the 48-week study ( LTG , n=39 ; CBZ , n=34 ) . Among the cognitive tests , significant group-by-time interaction was identified only in phonemic fluency of Controlled Oral Word Association Task ( p=0.0032 ) and Stroop Color-Word Interference ( p=0.0283 ) , with a significant better performance for LTG group . All other neuropsychological tests included did not show significant group-by-time interactions . Among the subscales of Symptom Check List-90 , significant group-by-time interactions were identified in Obsessive-Compulsive ( p=0.0005 ) , Paranoid Ideation ( p=0.0454 ) , Global Severity Index ( p=0.0194 ) , and Positive Symptom Total ( p=0.0197 ) , with a significant improvement for CBZ group . QOLIE-31 did not show significant group-by-time interactions . CONCLUSION Our data suggest that epilepsy patients on LTG have better performance on phonemic fluency and the task of Stroop Color-Word Interference than do patients on CBZ , whereas patients on CBZ had more favorable behavioral effects on two subscales and two global scores of Symptom Check List-90 than did patients on LTG Twenty-four patients with refractory epilepsy on one or more antiepileptic drugs were given additional vigabatrin ( 1 g twice daily for six weeks , followed by 1.5 g twice daily for a further six weeks ) and matched placebo in a double blind , r and omised , crossover study . A battery of neuropsychological tests was administered at baseline and at weeks two , six and 12 of both treatment periods . No significant differences were found between vigabatrin and placebo at any time point for any of the objective tests of cognitive function . Patients , however , reported a greater degree of sedation after two and six weeks on vigabatrin than during the equivalent placebo phase ( p < 0.01 ) , although no such difference was apparent at 12 weeks . Follow up over a mean of 14.75 months in 12 responders , who continued on vigabatrin , revealed a significant improvement ( all p < 0.01 ) on each of three composite scales ( three psychomotor tests , four memory tests , three self rating scales ) compared with their scores during the double blind trial . Vigabatrin did not cause cognitive impairment either acutely or in the long term . Phased introduction , however , seems a prudent policy to allow tolerance to early subjective sedation Lamotrigine is a broad-spectrum antiepileptic drug that blocks sodium channels , thereby inhibiting the pre-synaptic release of excitatory neurotransmitters . The primary aim of the study was to evaluate lamotrigine add-on therapy and consecutive monotherapy in patients with epilepsy whose seizures were not controlled by carbamazepine or valproate . One hundred and twenty six epilepsy patients at 18 centres in Pol and were recruited into a lamotrigine substitution study . In all patients , existing seizures were poorly controlled with valproate ( n= 63 ) or carbamazepine ( n= 63 ) monotherapy . The study consisted of four phases : ( 1 ) a 4-week lamotrigine dose-escalation phase , ( 2 ) an 8-week lamotrigine add-on phase , ( 3 ) an 8-week carbamazepine/valproate withdrawal phase , and ( 4 ) an 8-week lamotrigine monotherapy phase . Of 126 patients recruited into the study , 107 ( 85 % ) completed dose-escalation and add-on therapy with lamotrigine and 85 ( 68 % ) completed lamotrigine monotherapy . Fifty percent of patients during add-on therapy and 53 % during lamotrigine monotherapy experienced at least 50 % reduction in total seizures ( responders ) compared to the pre- study period . Approximately 20 % of patients during add-on therapy and 27 % during lamotrigine monotherapy were seizure free . Total well-being was assessed using a Visual Analogue Scale with 62 % of patients during add-on therapy and 60 % in lamotrigine monotherapy reporting improvement in scores . Lamotrigine was generally well tolerated . Treatment was discontinued in 7 % because of adverse events . In conclusion , lamotrigine is an effective AED in add-on therapy and monotherapy , it is safe and well tolerated , and successful conversion from add-on to monotherapy can be achieved in many cases . An additive effect between lamotrigine and valproate was observed Several specific and general measures are available for the assessment of overall health related quality of life in epilepsy . Few of the commonly used measures provide utility weights for use in cost-utility analyses . This study compares four methods for measuring utility weights : time trade-off ( TTO ) , st and ard gamble ( SG ) , 15D , end the EuroQol visual analog scale . All patients aged 18 - 67 years with a diagnosis of epilepsy , who had been admitted to or attended the outpatient clinic at a large county hospital 1987 - 1994 , received a comprehensive question naire . From 397 respondents , 82 patients were r and omly selected . Most of the 57 patients completing the study generally had well-controlled epilepsy , but were still on anti-epileptic medication . Mean age was 44 years . Fourty-one percent were male and 59 % female . The result ing utility weights differed considerably between the measures , both with regard to central tendency and dispersion . Median utility scores : EuroQol visual analog scale 0.75 , 15D 0.90 , TTO 0.98 , SG 0.99 . There was a good association between the EuroQol rating scale and the 15D , and a moderate association between SG and TTO . These preference instruments measure different aspects
Output:
| Javed noted that patients with ID were less likely to report side effects than patients without ID , especially in regard to cognitive adverse events [ 5 ] .
A recent Cochrane review concluded that side effects in the ID population are similar to the |
MS211870 | ***TASK*** the task is to summarize an input biomedical literature 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 effects of high-intensity , short- duration , re-warm-ups on team-sport-related performance were investigated . In a r and omised , cross-over study , participants performed 2 × 26-min periods of an intermittent activity protocol ( IAP ) on a non-motorized treadmill , interspersed by 15-min of passive recovery ( CON ) ; 3-min small-sided game ( SSG ) ; or a 5RM leg-press . Measures included counter-movement jump , repeated-sprint , the Loughborough soccer passing test ( LSPT ) , blood lactate concentration , heart-rate , and perceptual measures . Data were analyzed using effect size ( 90 % confidence intervals ) , and percentage change ; determining magnitudes of effects . A 5RM re-warm-up improved flight-time to contraction-time ratio when compared to SSG ( 9.8 % , ES ; 0.5±0.3 ) and CON ( ES : 9.4 % , 0.7±0.5 ) re-warm-ups , remaining higher following the second IAP ( 8.8 % , ES ; 0.5±0.3 and 10.2 % , ES ; 0.6±0.6 , respectively ) . Relative-maximum rate-of-force development was greater in the 5RM condition following the second IAP compared to SSG ( 29.3 % , ES ; 0.7±0.5 ) and CON ( 16.2 % , ES ; 0.6±0.6 ) . Repeated-sprint ability during the second IAP improved in the 5RM re-warm-up ; peak velocity , mean velocity , and acceleration were 4 , 3 , and 18 % greater , respectively . Within groups , the SSG re-warm-up improved LSPT performance post-intervention ; 6.4 % ( ES : 0.6±0.8 ) and following the second IAP 6.2 % ( ES : 0.6±0.6 ) , compared to pre-intervention . A 5RM leg-press re-warm-up improved physical performance , while a SSG re-warm-up enhanced skill execution following st and ardized intermittent exercise Sweeney , KM , Wright , GA , Brice , AG , and Doberstein , ST . The effect of β-alanine supplementation on power performance during repeated sprint activity . J Strength Cond Res 24(1 ) : 79 - 87 , 2010-The dipeptide carnosine has been shown to contribute to the buffer capacity of hydrogen ions ( H+ ) during intense exercise . Increasing skeletal muscle carnosine levels through β-alanine ( BA ) supplementation has been shown to maintain acid-base balance , delay fatigue , and improve exercise performance . We design ed this study to examine the effect of 5 weeks of BA supplementation on repeat high-intensity sprint performance . Nineteen , physically active , college men were divided into 2 groups ( control [ C ] , n = 10 or BA , n = 9 ) . We performed double-blind placebo-controlled study where subjects ingested 4 g per day during the first week and 6 g per day over the next 4 weeks of a placebo ( rice flour ) or a BA supplement . Subjects completed 2 sets of 5 5-second sprints with 45-second recovery separated by 2 minutes of active recovery . All tests were conducted on a non-motorized treadmill against a resistance of 15 % of the participant 's body weight . We recorded horizontal power ( HP ) of the running sprint . Post-exercise capillary blood sample s were analyzed for lactate to determine the metabolic dem and s. There were no significant between-group differences ( p > 0.05 ) in HPpeak or HPmean for the repeat sprint protocol . No significant between-group differences were found for performance decrement ( % fatigue ) for HPpeak or HPmean . In addition , no significant interactions were observed . Post-exercise blood lactate values were similar pre and post supplementation in both groups . The results of this study clearly indicate that 5 weeks of BA supplementation provides no benefit for repeat sprint performance We investigated the acute and chronic responses to multiple sets of repeated-sprint exercise ( RSE ) , focusing on changes in acceleration , intermittent running capacity and physiological responses . Ten healthy young adults ( 7 males , 3 females ) performed an incremental test , a Yo-Yo intermittent recovery test level1 ( Yo-Yo IR1 ) , and one session of RSE . RSE comprised three sets of 5 × 4-s maximal sprints on a non-motorised treadmill , with 20 s of passive recovery between repetitions and 4.5 min of passive recovery between sets . After ten repeated-sprint training sessions , participants repeated all tests . During RSE , performance was determined by measuring acceleration , mean and peak power/velocity . Recovery heart rate ( HR ) , HR variability , and finger-tip capillary lactate concentration ( [ Lac− ] ) were measured . Performance progressively decreased across the three sets of RSE , with the indices of repeated-sprint ability being impaired to a different extent before and after training . Training induced a significant increase ( p < 0.05 ) in all indices of performance , particularly acceleration ( 21.9 , 14.7 and 15.2 % during sets 1 , 2 and 3 , respectively ) . Training significantly increased Yo-Yo IR1 performance by 8 % and decreased Δ[Lac−]/work ratio ( −15.2 , −15.5 , −9.4 % during sets 1 , 2 and 3 , respectively ) and recovery HR during RSE . There were strong correlations between Yo-Yo IR1 performance and indices of RSE performance , especially acceleration post-training ( r = 0.88 , p = 0.004 ) . Repeated-sprint training , comprising only 10 min of exercise overall , effectively improved performance during multiple-set RSE . This exercise model better reflects team-sport activities than single-set RSE . The rapid training-induced improvement in acceleration , quantified here for the first time , has wide applications for professional and recreational sport activities Abstract Reliability refers to the reproducibility of values of a test , assay or other measurement in repeated trials on the same individuals . Better reliability implies better precision of single measurements and better tracking of changes in measurements in research or practical setting s. The main measures of reliability are within-subject r and om variation , systematic change in the mean , and retest correlation . A simple , adaptable form of within-subject variation is the typical ( st and ard ) error of measurement : the st and ard deviation of an individual ’s repeated measurements . For many measurements in sports medicine and science , the typical error is best expressed as a coefficient of variation ( percentage of the mean ) . A biased , more limited form of within-subject variation is the limits of agreement : the 95 % likely range of change of an individual ’s measurements between 2 trials . Systematic changes in the mean of a measure between consecutive trials represent such effects as learning , motivation or fatigue ; these changes need to be eliminated from estimates of within-subject variation . Retest correlation is difficult to interpret , mainly because its value is sensitive to the heterogeneity of the sample of participants . Uses of reliability include decision-making when monitoring individuals , comparison of tests or equipment , estimation of sample size in experiments and estimation of the magnitude of individual differences in the response to a treatment . Reasonable precision for estimates of reliability requires approximately 50 study participants and at least 3 trials . Studies aim ed at assessing variation in reliability between tests or equipment require complex design s and analyses that research ers seldom perform correctly . A wider underst and ing of reliability and adoption of the typical error as the st and ard measure of reliability would improve the assessment of tests and equipment in our disciplines Despite the exp and ing use of Whole Body Vibration training among athletes , it is not known whether adding Whole Body Vibration training to the conventional training of sprint-trained athletes will improve speed-strength performance . Twenty experienced sprint-trained athletes ( 13 male symbol , 7 female symbol , 17 - 30 years old ) were r and omly assigned to a Whole Body Vibration group ( n=10 : 6 male symbol and 4 female symbol ) or a Control group ( n=10 : 7 male symbol , 3 female symbol ) . During a 5-week experimental period all subjects continued their conventional training program , but the subjects of the Whole Body Vibration group additionally performed three times weekly a Whole Body Vibration training prior to their conventional training program . The Whole Body Vibration program consisted of unloaded static and dynamic leg exercises on a vibration platform ( 35 - 40 Hz , 1.7 - 2.5 mm , Power Plate ) . Pre and post isometric and dynamic ( 100 degrees/s ) knee-extensor and -flexor strength and knee-extension velocity at fixed resistances were measured by means of a motor-driven dynamometer ( Rev 9000 , Technogym ) . Vertical jump performance was measured by means of a contact mat . Force-time characteristics of the start action were assessed using a load cell mounted on each starting block . Sprint running velocity was recorded by means of a laser system . Isometric and dynamic knee-extensor and knee-flexor strength were unaffected ( p>0.05 ) in the Whole Body Vibration group and the Control group . As well , knee-extension velocity remained unchanged ( p>0.05 ) . The duration of the start action , the result ing start velocity , start acceleration , and sprint running velocity did not change ( > 0.05 ) in either group . In conclusion , this specific Whole Body Vibration protocol of 5 weeks had no surplus value upon the conventional training program to improve speed-strength performance in sprint-trained athletes The literature contains some hypotheses regarding the most favorable ground reaction force ( GRF ) for sprint running and how it might be achieved . This study tested the relevance of these hypotheses to the acceleration phase of a sprint , using GRF impulse as the GRF variable of interest . Thirty-six athletes performed maximal-effort sprints from which video and GRF data were collected at the 16-m mark . Associations between GRF impulse ( expressed relative to body mass ) and various kinematic measures were explored with simple and multiple linear regressions and paired t-tests . The regression results showed that relative propulsive impulse accounted for 57 % of variance in sprint velocity . Relative braking impulse accounted for only 7 % of variance in sprint velocity . In addition , the faster athletes tended to produce only moderate magnitudes of relative vertical impulse . Paired t-tests revealed that lower magnitudes of relative braking impulse were associated with a smaller touchdown distance ( p < 0.01 ) and a more active touchdown ( p < 0.001 ) . Also , greater magnitudes of relative propulsive impulse were associated with a high mean hip extension velocity of the stance limb ( p < 0.05 ) . In conclusion , it is likely that high magnitudes of propulsion are required to achieve high acceleration . Although there was a weak trend for faster athletes to produce lower magnitudes of braking , the possibility of braking having some advantages could not be ruled out . Further research is required to see if braking , propulsive , and vertical impulses can be modified with specific training . This will also provide insight into how a change in one GRF component might affect the others The aim of the study was to assess the reliability of sprint performance in both field and laboratory conditions . Twenty-one male ( mean ± s : 19 ± 1 years , 1.79 ± 0.07 m , 77.6 ± 7.1 kg ) and seventeen female team sport players ( mean ± s : 21 ± 4 years , 1.68 ± 0 . 07 m , 62.7 ± 4.7 kg ) performed a maximal 20-metre sprint running test on eight separate occasions . Four trials were conducted on a non-motorised treadmill in the laboratory ; the other four were conducted outdoors on a hard-court training surface with time recorded by single-beam photocells . Trials were conducted in r and om order with no familiarisation prior to testing . There was a significant difference between times recorded during outdoor field trials ( OFT ) and indoor laboratory trials ( ILT ) using a non-motorised treadmill ( 3.47 ± 0.53 vs. 6.06 ±1.17s ; p < 0.001 ) . The coefficient of variation ( CV ) for time was 2.55 - 4.22 % for OFT and 5.1 - 7.2 % for ILT . During ILT peak force ( 420.9 ± 87.7N ) , mean force ( 147.2 ± 24.7N ) , peak power ( 1376.8 ± 451.9W ) and mean power ( 514.8 ± 164.4W ) , and were measured . The CV for all ILT variables was highest during trial 1 - 2 comparison . The CV ( 95 % confidence interval ) for the trial 3 - 4 comparison yielded : 9.4 % ( 7.7 - 12 . 1 % ) , 7.9 % ( 6.4 - 10.2 % ) , 10.1 % ( 8.2 - 13.1 % ) and 6.2 % ( 5.1 - 8.0 % ) for PF , MF , PP and MP and respectively . The results indicate that reliable data can be derived for single maximal sprint measures , using fixed distance protocol s. However , significant differences in time/speed over 20-m exist between field and laboratory conditions . This is primarily due to the frictional resistance in the non- motorised treadmill . Measures of force and power during ILT require at least 3 familiarisations to reduce variability in test scores . Key pointsReliable data can be derived from single maximal sprint measures in both indoor and outdoor environments using fixed distance protocol s . There may be significant time differences to complete fixed distance trials between the two environments . Measures of mean force , peak force and peak power during indoor trials may require multiple trials to reduce variability in test scores & NA ; Lakomy , J. , and D.T. Haydon . The effects of enforced , rapid deceleration on performance in a multiple sprint test . J.
Output:
| However , low intraday reliability was reported for the theoretical maximum horizontal force ( ICC 0.64 ) within adolescent athletes , and low validity was reported for velocity during the initial 5 m of a sprint acceleration ( bias up to 0.41 m/s ) measured with a laser device .
There have been no reports to date of criterion validity of kinetic measures of sprint acceleration performance on NMT and TT , and only limited results regarding acceptable concurrent validity of radar-derived kinetic data .
Conclusions Radar , laser , NMT and TT technologies can be used to reliably measure sprint acceleration performance and to provide insight into the determinants of sprinting speed .
Radar and laser technology may not be suitable for measuring the first few steps of a sprint acceleration |
MS211871 | ***TASK*** the task is to summarize an input biomedical literature 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: Amputations of the lower extremity are still a common problem in diabetic feet and peripheral vasculopathies . The presented paper introduces a new device for an easier and faster mobilization of below-the-knee amputees . It is based on a new modular prostheses with individual inflatable air bladders . The compliance rate is higher with this device and it could be used from the day of surgery until the definitive prostheses is made . A biomechanical cadaver study with the prostheses will also be presented BACKGROUND Perioperative treatment of patients with colorectal cancer according to the Enhanced Recovery After Surgery ( ERAS ) protocol has proven to reduce complications and duration of stay . However , strict adherence remains a challenge and the benefits may decrease with lower adherence . In this study , we report on 8 years of adherence to the ERAS protocol and its effect on postoperative outcome in patients with colon cancer . METHODS In 2006 , the ERAS protocol was introduced for treatment of colon cancer patients in the Medical Center Alkmaar , a large teaching hospital . Patients scheduled for elective colon cancer resection were included in this study . Adherence to ERAS items was monitored and along with clinical data prospect ively gathered in a data base . In 2011 , several measures to improve adherence were implemented . RESULTS In total , 816 patients were included . Mean adherence rate was 73 % in 2006 and 2007 , 66 % in 2008 and 2009 , 63 % in 2010 and 2011 , and 82 % in 2012 and 2013 . There was a shorter duration of stay in the years with high adherence ( 5.7 days ) compared with the years with low adherence ( 7.3 days ; P < .001 ) . The ERAS items that were the strongest predictors for a shorter duration of stay were no nasogastric tube , early mobilization , early oral nutrition , early removal of epidural , early removal of catheter , and nonopioid oral analgesia . CONCLUSION It is possible to improve adherence to the ERAS protocol and related outcomes with specific measures . Adherence to the ERAS protocol was related inversely to duration of stay . Only postoperative items of the ERAS protocol were predictive for a shorter duration of stay . Keeping adherence optimal remains an ongoing challenge that requires repeated training and dedicated personnel To evaluate the use of an immediate postoperative prosthesis ( IPOP ) for transtibial amputees , we compared patient outcomes from a prospect i ve clinical study of 19 patients managed with an IPOP with those of a retrospective review of a matched historic control group of 23 patients managed with st and ard soft dressings . Data were analyzed with the Student 's t-test , and significance was set at P=0.05 . The IPOP patients had no surgical revisions , whereas the patients with st and ard soft dressings had 11 . This was a significant difference . IPOP patients also had significantly fewer postoperative complications and shorter times to custom prosthesis than did controls Eighty lower-extremity amputation patients were r and omly divided into two groups : one that ambulated ( A ) early ( 48 to 72 hours ) and one that did not ( NA ) . Group A patients used an immediate , post-operative , pneumatic splinting device . The two groups were compared as to the incidence of wound and constitutional post-operative complications , with the A group showing significantly fewer . As in previous studies , the A group continued toward quicker and more successful rehabilitation OBJECTIVES To estimate the prevalence of different levels of mobility in a hospitalized older cohort , to measure the degree and rate of adverse outcomes associated with different mobility levels , and to examine the physician activity orders and documented reasons for bedrest in the lowest mobility group . DESIGN A prospect i ve cohort study . SETTING An 800-bed university teaching hospital . PARTICIPANTS Four hundred ninety-eight hospitalized medical patients , aged 70 and older . MEASUREMENTS Using average mobility level , scored from 0 to 12 , the low-mobility group was defined as having a score of 4 or less , intermediate as a score of higher than 4 to 8 , and high as higher than 8 . Outcomes were functional decline , new institutionalization , death , and death or new institutionalization . RESULTS Low and intermediate levels of mobility were common , accounting for 80 ( 16 % ) and 157 ( 32 % ) study patients , respectively . Overall , any activity of daily living ( ADL ) decline occurred in 29 % , new institutionalization in 13 % , death in 7 % , and death or new institutionalization in 22 % of patients in this cohort . When compared with the high mobility group , the low and intermediate groups were associated with the adverse outcomes in a grade d fashion , even after controlling for multiple confounders . The low-mobility group had an adjusted odds ratio ( OR ) of 5.6 ( 95 % confidence interval (CI)=2.9 - 11.0 ) for ADL decline , 6.0 ( 95 % CI=2.5 - 14.8 ) for new institutionalization , 34.3 ( 95 % CI=6.3 - 185.9 ) for death , and 7.2 ( 95 % CI=3.6 - 14.4 ) for death or new institutionalization . The intermediate group had adjusted ORs of 2.5 ( 95 % CI=1.5 - 4.1 ) , 2.9 ( 95 % CI=1.4 - 6.0 ) , 10.1 ( 95 % CI=1.9 - 52.9 ) , and 3.3 ( 95 % CI=1.8 - 5.9 ) for ADL decline , new institutionalization , death , and death or new institutionalization , respectively . Bedrest was ordered at some point during hospitalization in 165 ( 33 % ) patients . For most patients , mobility was limited involuntarily ( bedrest orders ) , and almost 60 % of bedrest episodes in the lowest mobility group had no documented medical indication . CONCLUSION Low mobility and bedrest are common in hospitalized older patients and are important predictors of adverse outcomes . This study demonstrated that the adverse outcomes associated with low mobility and bedrest may be viewed as iatrogenic events leading to complications , such as functional decline It is common practice to keep those patients with lower extremity autografts immobile until post-operative day ( POD ) 5 . There is however inherent risks associated with even short periods of immobility . As of now there are no r and omized controlled trials looking at early ambulation of patients with lower extremity autografts in the burn community . The objective of this study was to show that patients who begin ambulation within 24 hours of lower extremity autografting will have no increased risk of graft failure than those patients who remain immobile until POD 5 . Thirty-one subjects who received autografts to the lower extremity were r and omized after surgery into either the early ambulation group ( EAG;17 subjects ) or the st and ard treatment group ( STG;14 subjects ) . Those subjects r and omized to the EAG began ambulating with physical therapy on POD 1 . Subjects in the STG maintained bed rest until POD 5 . There was no difference in the number of patients with graft loss in either the EAG or STG on POD 5 , and during any of the follow-up visits . No subjects required regrafting . There was a significant difference in the mean minutes of ambulation , with the EAG ambulating longer than the STG ( EAG 23.4 minutes [ SD 12.03 ] , STG 14.1 [ SD 9.00 ] , P=.0235 ) on POD 5 . Burn patients with lower extremity autografts can safely ambulate on POD 1 without fear of graft failure compared with those patients that remain on bed rest for 5 days
Output:
| CONCLUSIONS This systematic review reveals a lack of evidence to determine whether early mobilisation interventions are beneficial to this vulnerable patient group .
Nevertheless , ambulation from the first postoperative day with temporary prosthesis is possible among the heterogeneous population of dysvascular lower limb-amputated patients if the necessary interdisciplinary team is dedicated to the task . |
MS211872 | ***TASK*** the task is to summarize an input biomedical literature 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 evaluate the efficacy of a community-based adult obesity intervention in Angang . The intervention included health education activities among residents in a community in Anyang . 2400 and 1200 individual were r and omly selected as intervention group and control group respectively from a community in Anyang . The question nairing survey and body weight measuring were conducted and repeated at the end of the study for one year . The results showed that the awareness on the prevention of obesity was enhanced(P < 0.05 ) and mean weight of target population decreased . The community-based intervention for obesity was effective as well as feasible Background : Childhood obesity has become a nutritional problem in China since the 1990s . Aims : A family based behavioural treatment was developed and tested , to see if its use was feasible in China and to evaluate its impact on obese schoolchildren . Methods : In a single school in Beijing , 33 obese children were r and omly assigned to a treatment group and 35 to a control group . The treatment group participated in a family based behavioural treatment programme for two years . Height and weight were measured every six months for all participants . Blood pressure , cholesterol , and triglyceride levels were measured at baseline and after two years of programme implementation . Results : Body mass index ( BMI , kg/m2 ) was significantly reduced in the treatment group ( from 26.6 ( 1.7 ) to 24.0 ( 0.9 ) , 95 % CI 2.06 to 3.18 ) but not in the control group ( from 26.1 ( 1.5 ) to 26.0 ( 1.6 ) ) . Total cholesterol decreased 5.5 % and triglycerides 9.7 % in the treatment group . There was a significant correlation between change in BMI and change in triglycerides . There were no significant changes in plasma lipids in the controls . Blood pressure values also decreased significantly in the treatment , but not the control group . Conclusions : A family based behavioural intervention was feasible to use in treating obesity in schoolchildren in Beijing , China . After two years of implementation , it successfully decreased the degree of obesity , reduced levels of blood pressure , and decreased serum lipids in treatment ; there were no significant changes among control children OBJECTIVE To examine the effect of community-based health education and health promotion on body mass index ( BMI ) , overweight and obesity . METHODS We separately selected 100,000 population in Beijing , Shanghai and Changsha Cities during 1991 - 2000 . Each of the cities was then r and omly separated intervention and control community of 500,000 population . In the intervention community various kinds of health education and health promotion had been carried out . The level of knowledge , attitude and behavior ( KAB ) and body mass index ( BMI ) were evaluated . RESULTS The net increases of KAB level and regularly exercising rate in three city and different target population were statistically differences in comparison with baseline survey of 1992 , and the net decreases of the BMI , overweight rate and obesity rate of the whole population were statistically differences . CONCLUSION Health education and health promotion can effectively control the rising of population BMI , and have great meaningful for population preventing from cardio-cerebro-vascular diseases
Output:
| CONCLUSIONS Comprehensive interventions with at least physical activity , dietary intervention and health education may be effective in reducing obesity in Chinese children . |
MS211873 | ***TASK*** the task is to summarize an input biomedical literature 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 prevalence of obesity in the United States is a significant public health problem . Many obesity-related risk factors are more prevalent in minority population s. Given the recalcitrant nature of weight loss interventions for adults , prevention of overweight and obesity has become a high priority . The present study reports baseline data from an obesity prevention intervention developed for minority preschool children . METHODS Hip-Hop to Health Jr. is a 5-year r and omized controlled intervention that targets 3- to 5-year-old minority children enrolled in 24 Head Start programs . Our primary aim is to test the effect of the intervention on change in body mass index . Data were collected on sociodemographic , anthropometric , behavioral , and cognitive variables for the children and parents at baseline . RESULTS Participants included 416 black children , 337 black parents , 362 Latino children , and 309 Latino parents . Using body mass index for age and sex > or = the 95th percentile as the definition of overweight , 15 % of the black children and 28 % of the Latino children were overweight . More than 75 % of the parents were either overweight or obese . DISCUSSION The development of interventions to effectively prevent or control obesity early in life is crucial . These data highlight the escalating problem of weight control in minority population Context : Recent data indicate a marked increase in the prevalence of obesity among school-aged children . Thus , efficacious programmes that prevent overweight development in children are urgently needed . Objective : To evaluate the impact of repeatedly given , individualised dietary and lifestyle counselling on the prevalence of overweight during the first 10 years of life . Design and participants : This study was a part of the Special Turku Coronary Risk Factor Intervention Project for Children ( STRIP ) , which is a prospect i ve , r and omised trial aim ed at reducing the exposure of the intervention children to the known risk factors of atherosclerosis . At the child 's age of 7 months , 1062 children were assigned to an intervention group ( n=540 ) or to a control group ( n=522 ) . The intervention children received individualised counselling focused on healthy diet and physical activity biannually . Height and weight of the children were measured at least once a year . Main outcome measure : Prevalence of overweight and obesity among the intervention and control children by sex and age . Children were classified as overweight or obese if their weight for height was > 20 % or ⩾40 % above the mean weight for height of healthy Finnish children , respectively . Results : After the age of 2 years , there were continuously fewer overweight girls in the intervention group than in the control group . At the age of 10 years , 10.2 % of the intervention girls and 18.8 % of the control girls were overweight ( P=0.0439 ) , whereas 11.6 % of the intervention boys and 12.1 % of the control boys were overweight ( P≈1.00 ) . Only three children in the intervention group were obese at some age point , whereas 14 control children were classified as obese at some age point . Conclusion : Individualised dietary and lifestyle counselling given twice a year since infancy decreases prevalence of overweight in school-aged girls even without any primary energy restrictions BACKGROUND The evidence that breastfeeding protects against obesity and a variety of chronic diseases comes almost entirely from observational studies , which have a potential for bias due to confounding , selection bias , and selective publication . OBJECTIVE We assessed whether an intervention design ed to promote exclusive and prolonged breastfeeding affects children 's height , weight , adiposity , and blood pressure at age 6.5 y. DESIGN The Promotion of Breastfeeding Intervention Trial ( PROBIT ) is a cluster-r and omized trial of a breastfeeding promotion intervention based on the WHO/UNICEF Baby-Friendly Hospital Initiative . A total of 17,046 healthy breastfed infants were enrolled from 31 Belarussian maternity hospitals and their affiliated clinics ; of those infants , 13,889 ( 81.5 % ) were followed up at 6.5 y with duplicate measurements of anthropometric variables and blood pressure . Analysis was based on intention to treat , with statistical adjustment for clustering within hospitals or clinics to permit inferences at the individual level . RESULTS The experimental intervention led to a much greater prevalence of exclusive breastfeeding at 3 mo in the experimental than in the control group ( 43.3 % and 6.4 % , respectively ; P < 0.001 ) and a higher prevalence of any breastfeeding throughout infancy . No significant intervention effects were observed on height , body mass index , waist or hip circumference , triceps or subscapular skinfold thickness , or systolic or diastolic blood pressure . CONCLUSIONS The breastfeeding promotion intervention result ed in substantial increases in the duration and exclusivity of breastfeeding , yet it did not reduce the measures of adiposity , increase stature , or reduce blood pressure at age 6.5 y in the experimental group . Previously reported beneficial effects on these outcomes may be the result of uncontrolled confounding and selection bias Exercise has been found to be effective for prevention of weight gain and maintenance of a stable weight in adults . The objective of this study was to evaluate the effect of a school-based aerobic exercise program on the obesity indexes of preschool children . Subjects were 292 second-year elementary school pupils from 2 kindergartens in Hat Yai municipality , Songkhla province , southern Thail and . A specially design ed exercise program , including a 15-min walk before beginning the morning class and a 20-min aerobic dance session after the afternoon nap , 3 times a week , was conducted for 29.6 wk . Weight , height , and triceps skinfold thickness were measured 4 times . At the end of the study , the prevalence of obesity , using 95th percentile National Center for Health Statistics triceps-skinfold-thickness cutoffs , of both the exercise and control groups decreased . That of the exercise group decreased from 12.2 % at baseline to 8.8 % ( Wilcoxon signed-rank test , P = 0.058 ) , whereas that of the control group decreased from 11.7 % to 9.7 % ( Wilcoxon signed-rank test , P = 0.179 ) . A sex difference in the response of body mass index ( BMI ) to exercise was observed . Girls in the exercise group had a lower likelihood of having an increasing BMI slope than the control girls did ( odds ratio : 0.32 ; 95 % CI : 0.18 , 0.56 ) . In conclusion , our study suggests that a 29.6-wk school-based exercise program can prevent BMI gain in girls and may induce a remission of obesity in preschool-age children The evidence that breast-feeding protects against obesity is based on observational studies , with potential for confounding and selection bias . This article summarizes a previously published study in which we assessed whether an intervention design ed to promote exclusive and prolonged breast-feeding affects children 's height , weight , adiposity , and blood pressure ( BP ) at age 6.5 y. The Promotion of Breastfeeding Intervention Trial ( PROBIT ) is a cluster-r and omized trial of a breast-feeding promotion intervention based on the WHO/UNICEF Baby-Friendly Hospital Initiative . A total of 17,046 healthy breast-fed infants were enrolled from 31 Belarussian maternity hospitals and affiliated clinics , of whom 13,889 ( 81.5 % ) were followed up at 6.5 y with duplicate measurements of height , weight , waist circumference , triceps and subscapular skinfold thicknesses , systolic and diastolic BP . Analysis was based on intention to treat , with statistical adjustment for clustering within hospitals/clinics to permit inferences at the individual level . The experimental intervention led to a large increase in exclusive breast-feeding at 3 mo ( 43.3 % vs. 6.4 % , P < 0.001 ) and a significantly higher prevalence of any breast-feeding throughout infancy . No significant intervention effects were observed on height , BMI , adiposity measures , or BP . The breast-feeding promotion intervention result ed in substantial increases in the duration and exclusivity of breast-feeding yet did not reduce measures of adiposity at age 6.5 y. Previous reports of protective effects against obesity may reflect uncontrolled bias caused by confounding and selection Objective To assess whether a physical activity intervention reduces body mass index in young children . Design Cluster r and omised controlled single blinded trial over 12 months . Setting Thirty six nurseries in Glasgow , Scotl and . Participants 545 children in their preschool year , mean age 4.2 years ( SD 0.2 ) at baseline . Intervention Enhanced physical activity programme in nursery ( three 30 minute sessions a week over 24 weeks ) plus home based health education aim ed at increasing physical activity through play and reducing sedentary behaviour . Main outcome measure Body mass index , expressed as a st and ard deviation score relative to UK 1990 reference data . Secondary measures were objective ly measured physical activity and sedentary behaviour ; fundamental movement skills ; and evaluation of the process . Results Group allocation had no significant effect on the primary outcome measure at six and 12 months or on measures of physical activity and sedentary behaviour by accelerometry . Children in the intervention group had significantly higher performance in movement skills tests than control children at six month follow-up ( P=0.0027 ; 95 % confidence interval 0.3 to 1.3 ) after adjustment for sex and baseline performance . Conclusions Physical activity can significantly improve motor skills but did not reduce body mass index in young children in this trial . Trial registration Current Controlled Trials IS RCT N36363490 OBJECTIVE To investigate whether dietary counseling design ed for primary prevention of atherosclerosis and given repeatedly since infancy had an effect on prepubertal children 's body satisfaction . DESIGN R and omized controlled trial . PARTICIPANTS At the age of 7 months , 1062 infants were r and omized to an intervention group ( n = 540 ) or a control group ( n = 522 ) . At the age of 8 years , body satisfaction of 217 children in the intervention group and 218 in the control group was evaluated . Intervention Since the children were 8 months old , families in the intervention group had regularly received individualized health education and dietary advice aim ed at decreasing the children 's intake of saturated fat and cholesterol . MAIN OUTCOME MEASURES A pictorial instrument was used in measuring estimated current and desired body sizes ; a difference between the 2 indicated body dissatisfaction . Weight and height were measured . RESULTS When adjusted for relative weight , there were no differences in the mean values of estimated current size , desired size , or body dissatisfaction between the girls in the intervention and control groups ( P = .62 , P = .72 , and P = .39 , respectively ) , or between the boys in the intervention and control groups ( P = .21 , P = .64 , and P = .53 , respectively ) . The proportions of children who were satisfied with their size , who wished to be thinner , or who wished to look heavier did not differ between the intervention and control groups in either girls ( P = .65 ) or boys ( P = .85 ) . CONCLUSION Long-term , individualized dietary counseling since infancy with the focus on dietary fat did not enhance body dissatisfaction or desire to be thinner in 8-year-old children OBJECTIVE To determine whether maternal participation in an obesity prevention plus parenting support ( OPPS ) intervention would reduce the prevalence of obesity in high-risk Native-American children when compared with a parenting support (PS)-only intervention . RESEARCH METHODS AND PROCEDURES Forty-three mother/child pairs were recruited to participate . Mothers were 26.5 + /- 5 years old with a mean BMI of 29.9 + /- 3 kg/m(2 ) . Children ( 23 males ) were 22 + /- 8 months old with mean weight-for-height z ( WHZ ) scores of 0.73 + /- 1.4 . Mothers were r and omly assigned to a 16-week OPPS intervention or PS alone . The intervention was delivered one-on-one in homes by an indigenous peer educator . Baseline and week 16 assessment s included weight and height ( WHZ score and weight-for-height percentile for children ) , dietary intake ( 3-day food records ) , physical activity ( measured by accelerometers ) , parental feeding style ( Child Feeding Question naire ) , and maternal outcome expectations , self-efficacy , and intention to change diet and exercise behaviors . RESULTS Changes in WHZ scores showed a trend toward significance , with WHZ scores decreasing in the PS condition and increasing among the OPPS group ( -0.27 + /- 1.1 vs. 0.31 + /- 1.1 , p = 0.06 ) . Children in the OPPS condition also significantly decreased energy intake ( -316 + /- 835 kcal/d vs. 197 + /- 608 kcal/d , p < 0.05 ) . Scores on the restriction subscale of the Child Feeding Question naire decreased significantly in the OPPS condition ( -0.22+/- 0.42 vs. 0.08+/- 0.63 , p < 0.05 ) , indicating that mothers in the OPPS group were engaging in less restrictive child feeding practice s over time . DISCUSSION A home-visiting program focused on changing lifestyle behaviors and improving parenting skills showed promise for obesity prevention in high-risk Native-American children OBJECTIVE . Our goal was to study childhood growth patterns and development of overweight in children who were
Output:
| None of the interventions had an effect in preventing overweight and obesity . |
MS211874 | ***TASK*** the task is to summarize an input biomedical literature 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 Consoli date d St and ards for Reporting of Trials ( CONSORT ) statement was developed to help improve the quality of reports of r and omized controlled trials ( RCTs ) . To date , a paucity of data exists regarding whether it has achieved this goal . OBJECTIVE To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs . DESIGN AND SETTING Comparative before- and -after evaluation in which reports of RCTs published in 1994 ( pre-CONSORT ) were compared with RCT reports from the same journals published in 1998 ( post-CONSORT ) . We included 211 reports from BMJ , JAMA , and The Lancet ( journals that adopted CONSORT ) as well as The New Engl and Journal of Medicine ( a journal that did not adopt CONSORT and was used as a comparator ) . MAIN OUTCOME MEASURES Number of CONSORT items included in a report , frequency of unclear reporting of allocation concealment , and overall trial quality score based on the Jadad scale , a 5-point quality assessment instrument . RESULTS Compared with 1994 , the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998 , and this increase was statistically significant for the 3 adopter journals ( pre-CONSORT , 23.4 ; mean change , 3.7 ; 95 % confidence interval [ CI ] , 2.1 - 5.3 ) . The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals , and this change was statistically significant for adopters ( pre-CONSORT , 61 % ; mean change , -22 % ; 95 % CI , -38 % to -6 % ) . Similarly , 3 of the 4 journals showed an improvement in the quality score for reports of RCTs , and this increase was statistically significant for adopter journals overall ( pre-CONSORT , 2.7 ; mean change , 0.4 ; 95 % CI , 0.1 - 0.8 ) . CONCLUSION Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs Background Recent research identifies unhealthful weight-control behaviors ( fasting , vomiting , or laxative abuse ) induced by a negative experience of the body , as the common antecedents of both obesity and eating disorders . In particular , according to the allocentric lock hypothesis , individuals with obesity may be locked to an allocentric ( observer view ) negative memory of the body that is no longer up date d by contrasting egocentric representations driven by perception . In other words , these patients may be locked to an allocentric negative representation of their body that their sensory inputs are no longer able to up date even after a dem and ing diet and a significant weight loss . Objective To test the brief and long-term clinical efficacy of an enhanced cognitive-behavioral therapy including a virtual reality protocol aim ed at unlocking the negative memory of the body ( ECT ) in morbidly obese patients with binge eating disorders ( BED ) compared with st and ard cognitive behavior therapy ( CBT ) and an inpatient multimodal treatment ( IP ) on weight loss , weight loss maintenance , BED remission , and body satisfaction improvement , including psychonutritional groups , a low-calorie diet ( 1200 kcal/day ) , and physical training . Methods 90 obese ( BMI > 40 ) female patients with BED upon referral to an obesity rehabilitation center were r and omly assigned to conditions ( 31 to ECT , 30 to CBT , and 29 to IP ) . Before treatment completion , 24 patients discharged themselves from hospital ( 4 in ECT , 10 in CBT , and 10 in IP ) . The remaining 66 in patients received either 15 sessions of ECT , 15 sessions of CBT , or no additional treatment over a 5-week usual care inpatient regimen ( IP ) . ECT and CBT treatments were administered by 3 licensed psychotherapists , and patients were blinded to conditions . At start , upon completion of the inpatient treatment , and at 1-year follow-up , patients ' weight , number of binge eating episodes during the previous month , and body satisfaction were assessed by self-report question naires and compared across conditions . 22 patients who received all sessions did not provide follow-up data ( 9 in ECT , 6 in CBT , and 7 in IP ) . Results Only ECT was effective at improving weight loss at 1-year follow-up . Conversely , control participants regained on average most of the weight they had lost during the inpatient program . Binge eating episodes decreased to zero during the inpatient program but were reported again in all the three groups at 1-year follow-up . However , a substantial regain was observed only in the group who received the inpatient program alone , while both ECT and CBT were successful in maintaining a low rate of monthly binge eating episodes . Conclusions Despite study limitations , findings support the hypothesis that the integration of a VR-based treatment , aim ed at both unlocking the negative memory of the body and at modifying its behavioral and emotional correlates , may improve the long-term outcome of a treatment for obese BED patients . As expected , the VR-based treatment , in comparison with the st and ard CBT approach , was able to better prevent weight regain but not to better manage binge eating episodes . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 59019572 ; http://www.controlled-trials.com/IS RCT N59019572 ( Archived by WebCite at http://www.webcitation.org/6GxHxAR2 G Body image ( BI ) disturbances are considered to be central in eating disorders ( ED ) psychopathology . There are few studies focused on the treatment of BI disturbances in ED , and most of them have used " traditional methods . " The purpose of the present study was to probe the effectiveness of one specific component in the assessment and treatment of BI in ED by means of virtual reality ( VR ) . Two treatment conditions were applied : ( a ) The St and ard Body Image Treatment Condition ( SBIT ) and ( b ) the VR Condition . Thirteen eating disordered patients were r and omly assigned to one of those conditions . No differences between both conditions were found in general ED measures , but patients treated in the VR condition showed a greater significant improvement in specific BI measures . These results suggest that BI treatment with VR could be more targeted to its disturbances . than traditional techniques are The aim of this article was to study the effect of virtual-reality exposure to situations that are emotionally significant for patients with eating disorders ( ED ) on the stability of body-image distortion and body-image dissatisfaction . A total of 85 ED patients and 108 non-ED students were r and omly exposed to four experimental virtual environments : a kitchen with low-calorie food , a kitchen with high-calorie food , a restaurant with low-calorie food , and a restaurant with high-calorie food . In the interval between the presentation of each situation , body-image distortion and body-image dissatisfaction were assessed . Several 2 x 2 x 2 repeated measures analyses of variance ( high-calorie vs. low-calorie food x presence vs. absence of people x ED group vs. control group ) showed that ED participants had significantly higher levels of body-image distortion and body dissatisfaction after eating high-calorie food than after eating low-calorie food , while control participants reported a similar body image in all situations . The results suggest that body-image distortion and body-image dissatisfaction show both trait and state features . On the one h and , ED patients show a general predisposition to overestimate their body size and to feel more dissatisfied with their body image than controls . On the other h and , these body-image disturbances fluctuate when participants are exposed to virtual situations that are emotionally relevant for them Binge eating is often preceded by reports of negative affect , but the mechanism by which affect may lead to binge eating is unclear . This study evaluated the effect of negative affect on neural response to anticipation and receipt of palatable food in women with bulimia nervosa ( BN ) versus healthy controls . We also evaluated connectivity between the amygdala and reward-related brain regions . Females with and without BN ( n=26 ) underwent functional magnetic resonance imaging ( fMRI ) during receipt and anticipated receipt of chocolate milkshake and a tasteless solution . We measured negative affect just prior to the scan . Women with BN showed a positive correlation between negative affect and activity in the putamen , cau date , and pallidum during anticipated receipt of milkshake ( versus tasteless solution ) . There were no significant relations between negative affect and receipt of milkshake . Connectivity analyses revealed a greater relation of amygdala activity to activation in the left putamen and insula during anticipated receipt of milkshake in the bulimia group relative to the control group . The opposite pattern was found for the taste of milkshake ; the control group showed a greater relation of amygdala activity to activation in the left putamen and insula in response to milkshake receipt than the bulimia group . Results show that as negative affect increases , so does responsivity of reward regions to anticipated intake of palatable food , implying that negative affect may increase the reward value of food for individuals with bulimia nervosa or that negative affect has become a conditioned cue due to a history of binge eating in a negative mood Background Many research ers and clinicians have proposed using virtual reality ( VR ) in adjunct to in vivo exposure therapy to provide an innovative form of exposure to patients suffering from different psychological disorders . The rationale behind the ' virtual approach ' is that real and virtual exposures elicit a comparable emotional reaction in subjects , even if , to date , there are no experimental data that directly compare these two conditions . To test whether virtual stimuli are as effective as real stimuli , and more effective than photographs in the anxiety induction process , we tested the emotional reactions to real food ( RF ) , virtual reality ( VR ) food and photographs ( PH ) of food in two sample s of patients affected , respectively , by anorexia ( AN ) and bulimia nervosa ( BN ) compared to a group of healthy subjects . The two main hypotheses were the following : ( a ) the virtual exposure elicits emotional responses comparable to those produced by the real exposure ; ( b ) the sense of presence induced by the VR immersion makes the virtual experience more ecological , and consequently more effective than static pictures in producing emotional responses in humans . Methods In total , 10 AN , 10 BN and 10 healthy control subjects ( CTR ) were r and omly exposed to three experimental conditions : RF , PH , and VR while their psychological ( Stait Anxiety Inventory ( STAI-S ) and visual analogue scale for anxiety ( VAS-A ) ) and physiological ( heart rate , respiration rate , and skin conductance ) responses were recorded . Results RF and VR induced a comparable emotional reaction in patients higher than the one elicited by the PH condition . We also found a significant effect in the subjects ' degree of presence experienced in the VR condition about their level of perceived anxiety ( STAI-S and VAS-A ) : the higher the sense of presence , the stronger the level of anxiety . Conclusions Even though preliminary , the present data show that VR is more effective than PH in eliciting emotional responses similar to those expected in real life situations . More generally , the present study suggests the potential of VR in a variety of experimental , training and clinical context s , being its range of possibilities extremely wide and customizable . In particular , in a psychological perspective based on a cognitive behavioral approach , the use of VR enables the provision of specific context s to help patients to cope with their diseases thanks to an easily controlled stimulation Body-image dissatisfaction is a problem that affects a substantial minority ofwomen and cuts across various diagnostic groups . College women with a significant level ofbody-image dissatisfaction were r and omly assigned to either a cognitive-behavioral treatment ( CBT ) program ( n = 15 ) or to a waiting-list control group ( n = 16 ) . The CBT program consisted of six structured , individual sessions that applied cognitive-behavioral procedures to the problem of negative body image . At pretest , posttest , and 7-week foUow-up , multiple aspects of body image and other areas of psychosocial functioning were assessed . Relative to the control condition , the CBT program successfully improved affective body image , weakened maladaptive body-image cognitions , and enhanced social self-esteem and feelings about physical fitness and sexuality . Treatment effects were largely maintained at followup . After posttest , the control group received a 3-week treatment with immediate effects that generally replicated those obtained in the 6-wer program Treating binge eating disorders is not easy : the disordered eating is usually combined with a patient who is overweight and often obese . As underlined by the current literature , treatment outcome must focus , at a minimum , on the binge eating characterizing this disorder , on weight changes , and preferably also changes in co-morbid psychopathology . To address these issues , cognitive behavioral therapy ( CBT ) is still considered the best approach . However , if we check the results of follow-up studies , different authors reported some relapse in the frequency of binge eating and small weight gains over the follow-up period . This paper describes the 6-month follow-up outcome of the Experiential Cognitive Therapy ( ECT ) , a multi factorial treatment for binge eating disorders , including virtual reality therapy . These results are compared in a r and omized controlled trial ( n = 36 ) with the ones obtained by CBT and nutritional groups only . The results showed that 77 % of the ECT group quit binging after 6 months versus 56 % for the CBT sample and 22 % for the nutritional group sample . Moreover , the ECT sample reported better scores in most psychometric tests including EDI-2 and body image scores The main goal of this paper is to preliminarily evaluate the efficacy of a virtual-reality (VR)-based multidimensional approach in the treatment of body image attitudes and related constructs . The female binge eating disorder ( BED ) patients ( n=20 ) , involved in a residential weight control treatment including low-calorie diet (
Output:
| However , considering the available evidence , the use of VR in the assessment of those conditions showed some promise in identifying : ( 1 ) how those patients experienced their body image ; and ( 2 ) environments or specific kinds of foods that may trigger binge-purging cycle .
Some studies using VR-based environments associated to cognitive behavioral techniques showed their potential utility in improving motivation for change , self-esteem , body image disturbances and in reducing binge eating and purging behavior |
MS211875 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The purpose of this study was to test agreement in blood values obtained from a discard method and a push-pull method in sample s from central venous catheters in pediatric patients . The discard method causes blood loss beyond what is necessary for blood testing and increases potential for infection each time the central venous catheter is entered . Twenty-eight children ranging in age from 6 months to 12 years were enrolled in the study . A research protocol was developed to pair the 2 methods of blood collection for each sample . The Bl and -Altman method was used to test agreement on each blood value for each paired sample . Of the 438 pairs of measured blood values , 420 ( 95.9 % ) fell within the limits of agreement . Nurses reported no difficulty in using the push-pull technique to obtain any sample s. The push-pull method of obtaining blood specimens from pediatric central venous catheters should be considered . It can eliminate blood loss through discard and can reduce infection because it reduces the number of times a catheter is entered Purpose / Objective : The purpose of this study was to test an evidence -based procedure of drawing blood sample s for coagulation testing from heparinized peripherally inserted central catheter ( PICC ) by comparing results with blood drawn from venipuncture ( VP ) . Design : A prospect i ve , quasi-experimental design using purposive sampling was used . Setting : The setting was a 230-bed community hospital located in the Southwest . The hospital is part of a 15-hospital system . Sample : The sample was composed of 30 hospitalized patients with heparinized PICCs . Methods : Informed consent was obtained . Using aseptic technique , sample s of blood were drawn via VP and from the PICC using the evidence -based procedure . Data were analyzed using Pearson product moment correlations and Bl and -Altman analysis . Findings : For 5 coagulation tests studied , correlations between PICC values and VP values ranged from 0.990 to 0.998 , indicating almost perfect correlations . In Bl and -Altman analyses , mean biases and SDs were small to moderate for prothrombin time , 0.13 seconds ( −0.55 to 0.81 seconds ) ( P = 0.0484 ) ; international normalized ratio , 0.010 ( −0.050 to 0.070 ) ( P = 0.085 ) ; partial thromboplastin time , 2.16 seconds ( −5.10 to 9.43 seconds ) ( P = 0.0033 ) ; and fibrinogen , −18.2 mg ( −70.4 to 34.1 mg ) ( P = 0.0033 ) and 0.52 ( −0.73 to 1.77 ) seconds ( P = 0.0003 ) . Correlations of absolute difference versus average ranged from 0.18 to 0.49 . Only the paired international normalized ratio sample s had P values suggesting nonagreement . Conclusions : Drawing blood sample s from heparinized PICCs for coagulation tests using the evidence -based procedure developed for this study result ed in accurate coagulation test results in 4 of the 5 tests : prothrombin time , partial thromboplastin time , and fibrinogen in seconds and in milligrams PURPOSE / OBJECTIVES Determine the blood volume that must be wasted to obtain a clinical ly useful prothrombin time ( PT ) , activated partial thromboplastin time ( APTT ) , and fibrinogen concentration for blood drawn from a heparinized ( 2.5 ml of 100 units/ml ) , double-lumen venous catheter . DESIGN Prospect i ve , nonr and omized study comparing test results obtained from blood sample s drawn through the catheters with those obtained via peripheral venipuncture . Patients acted as their own control . SETTING Inpatient and outpatient units of a cancer research center located in a mid-Atlantic city in the United States . SAMPLE Twenty double-lumen 10 Fr . Hickman catheters ( Bard Access Systems , Salt Lake City , UT ) were studied in 20 adult patients with cancer who had no history of coagulation disorders . METHODS Sample s were collected from the red lumen of 20 heparinized , double-lumen Hickman catheters after 5 , 10 , 15 , 20 , and 25 ml of blood first were discarded . PTs , APTTs , and fibrinogen concentrations were measured on each sample . The results were compared with those derived from a simultaneously obtained peripheral blood sample . MAIN RESEARCH VARIABLES PT , APTT , and fibrinogen values of blood sample s after 5 , 10 , 15 , 20 , and 25 ml discards and PT , APTT , and fibrinogen of peripheral blood sample s. FINDINGS The coagulation results using peripheral blood were always within the normal range except for one slightly elevated APTT . After 25 ml of discard , all of the PTs and fibrinogen concentrations and 95 % of the APTTs of catheter blood were within the normal range and therefore clinical ly useful . CONCLUSIONS Clinical ly useful PTs , APTTs , and fibrinogen concentrations often can be derived with catheter-drawn blood when the objective is to confirm normal coagulation . However , because it is very difficult to obtain heparin-free sample s through heparinized , double-lumen Hickman catheters , peripheral blood should be drawn for coagulation testing when a totally heparin-free sample is needed to make a critical clinical decision . IMPLICATION S FOR NURSING PRACTICE These findings provide important information for practice when nurses have to decide whether to draw coagulation tests through a heparinized catheter . Further research is needed with larger sample s in varied population s ( e.g. , pediatrics ) to study catheters made of different material s and of different calibers
Output:
| FINDINGS The only method for obtaining reliable coagulation test results from central venous access devices is the flush then waste/discard method . |
MS211876 | ***TASK*** the task is to summarize an input biomedical literature 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 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 We tested the hypothesis that serum isoform [-2]proPSA derivatives % p2PSA and Prostate Health Index are accurate predictors of prostate cancer in men scheduled for repeat biopsy . MATERIAL S AND METHODS The study was an observational prospect i ve evaluation of a clinical cohort of men with 1 or 2 previous negative prostate biopsies , with persistent suspicion of prostate cancer . They were enrolled in the study to determine the diagnostic accuracy of % p2PSA using the formula , ( p2PSA pg/ml)/(free prostate specific antigen ng/ml × 1,000)] × 100 , and Beckman-Coulter Prostate Health Index using the formula , ( p2PSA/free prostate specific antigen ) × √total prostate specific antigen ) , and to compare it with the accuracy of established prostate cancer serum tests ( total prostate specific antigen , free prostate specific antigen and percent free prostate specific antigen ) . Multivariable logistic regression models were complemented by predictive accuracy analysis and decision curve analysis . RESULTS Prostate cancer was found in 71 of 222 ( 31.9 % ) subjects . % p2PSA and Prostate Health Index were the most accurate predictors of disease . % p2PSA significantly outperformed total prostate specific antigen , free prostate specific antigen , percent free prostate specific antigen and p2PSA in the prediction of prostate cancer ( p ≤0.01 ) , but not Prostate Health Index ( p = 0.094 ) . Prostate Health Index significantly outperformed total prostate specific antigen and p2PSA ( p ≤0.001 ) but not free prostate specific antigen ( p = 0.109 ) and free/total prostate specific antigen ( p = 0.136 ) . In multivariable logistic regression models % p2PSA and Prostate Health Index achieved independent predictor status , and significantly increased the accuracy of multivariable models including prostate specific antigen and prostate volume with or without percent free prostate specific antigen and prostate specific antigen density by 8 % to 11 % ( p ≤0.034 ) . At a % p2PSA cutoff of 1.23 , 153 ( 68.9 % ) biopsies could have been avoided , missing prostate cancer in 6 patients . At a Prostate Health Index cutoff of 28.8 , 116 ( 52.25 % ) biopsies could have been avoided , missing prostate cancer in 6 patients . CONCLUSIONS Serum % p2PSA and Prostate Health Index are more accurate than st and ard reference tests in predicting repeat prostate biopsy outcome , and could avoid unnecessary repeat biopsies Study Type – Diagnosis ( exploratory cohort ) Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men . In the United States , 90 % of men with prostate cancer are more than age 60 years , diagnosed by early detection with the prostate-specific antigen ( PSA ) blood test , and have disease believed confined to the prostate gl and ( clinical ly localized ) . Common treatments for clinical ly localized prostate cancer include watchful waiting ( WW ) , surgery to remove the prostate gl and ( radical prostatectomy ) , external-beam radiation therapy and interstitial radiation therapy ( brachytherapy ) , and and rogen deprivation . Little is known about the relative effectiveness and harms of treatments because of the paucity of r and omized controlled trials . The Department of Veterans Affairs/National Cancer Institute/Agency for Healthcare Research and Quality Cooperative Studies Program Study # 407:Prostate Cancer Intervention Versus Observation Trial ( PIVOT ) , initiated in 1994 , is a multicenter r and omized controlled trial comparing radical prostatectomy with WW in men with clinical ly localized prostate cancer . We describe the study rationale , design , recruitment methods , and baseline characteristics of PIVOT enrollees . We provide comparisons with eligible men declining enrollment and men participating in another recently reported r and omized trial of radical prostatectomy vs WW conducted in Sc and inavia . We screened 13 022 men with prostate cancer at 52 US medical centers for potential enrollment . From these , 5023 met initial age , comorbidity , and disease eligibility criteria , and a total of 731 men agreed to participate and were r and omized . The mean age of enrollees was 67 years . Nearly one-third were African American . Approximately 85 % reported that they were fully active . The median PSA was 7.8ng/mL ( mean 10.2ng/mL ) . In three-fourths of men , the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise . Using previously developed tumor risk categorizations incorporating PSA levels , Gleason histologic grade , and tumor stage , it was found that approximately 40 % had low-risk , 34 % had medium-risk , and 21 % had high-risk prostate cancer based on local histopathology . Comparison to our national sample of eligible men declining PIVOT participation as well as to men enrolled in the Sc and inavian trial indicated that PIVOT enrollees are representative of men being diagnosed and treated in the United States and quite different from men in the Sc and inavian trial . PIVOT enrolled an ethnically diverse population representative of men diagnosed with prostate cancer in the United States . Results will yield important information regarding the relative effectiveness and harms of surgery compared with WW for men with predominately PSA-detected clinical ly localized prostate cancer BACKGROUND The Prostate CAncer gene 3 ( PCA3 ) assay has shown promise as an aid in prostate cancer ( pCA ) diagnosis in identifying men with a high probability of a positive ( repeat ) biopsy . OBJECTIVE This study evaluated the clinical utility of the PROGENSA PCA3 assay . DESIGN , SETTING , AND PARTICIPANTS This European prospect i ve , multicentre study enrolled men with one or two negative biopsies scheduled for repeat biopsy . MEASUREMENTS After digital rectal examination ( DRE ) , first-catch urine was collected to measure PCA3 mRNA concentration and to calculate the PCA3 score . The PCA3 score was compared to biopsy outcome . The diagnostic accuracy of the PCA3 assay was compared to percent of free prostate-specific antigen ( % fPSA ) . RESULTS AND LIMITATIONS In 463 men , the positive repeat biopsy rate was 28 % . The higher the PCA3 score , the greater the probability of a positive repeat biopsy . The PCA3 score ( cut-off of 35 ) had a greater diagnostic accuracy than % fPSA ( cut-off of 25 % ) . The PCA3 score was independent of the number of previous biopsies , age , prostate volume , and total prostate-specific antigen ( PSA ) level . Moreover , the PCA3 score was significantly higher in men with high- grade prostate intraepithelial neoplasia ( HGPIN ) versus those without HGPIN , clinical stage T2 versus T1 , Gleason score > or=7 versus < 7 , and " significant " versus " indolent " ( clinical stage T1c , PSA density [ PSAD ] < 0.15ng/ml , Gleason score in biopsy < or=6 , and percent positive cores < or=33 % ) pCA . CONCLUSIONS The probability of a positive repeat biopsy increases with rising PCA3 scores . The PCA3 score was superior to % fPSA for predicting repeat prostate biopsy outcome and may be indicative of clinical stage and significance of pCa Background : Identification of men harbouring insignificant prostate cancer ( PC ) is important in selecting patients for active surveillance . Tools have been developed in PSA-screened population s to identify such men based on clinical and biopsy parameters . Methods : Prospect ively collected case series of 848 patients was treated with radical prostatectomy between July 2007 and October 2011 at an English tertiary care centre . Tumour volume was assessed by pathological examination . For each tool , receiver operator characteristics were calculated for predicting insignificant disease by three different criteria and the area under each curve compared . Comparison of accuracy in screened and unscreened population s was performed . Results : Of 848 patients , 415 had Gleason 3 + 3 disease on biopsy . Of these , 32.0 % had extra-prostatic extension and 50.2 % were up grade d. One had positive lymph nodes . Two hundred and six ( 24 % of cohort ) were D’Amico low risk . Of these , 143 had more than two biopsy cores involved . None of the tools evaluated has adequate discriminative power in predicting insignificant tumour burden . Accuracy is low in PSA-screened and -unscreened population s. Conclusions : In our unscreened population , tools design ed to identify insignificant PC are inaccurate . Detection of a wider size range of prostate tumours in the unscreened may contribute to relative inaccuracy BACKGROUND After 11 years of follow-up , the European R and omized Study of Screening for Prostate Cancer ( ERSPC ) reported a 29 % reduction in prostate-cancer mortality among men who underwent screening for prostate-specific antigen ( PSA ) levels . However , the extent to which harms to quality of life result ing from overdiagnosis and treatment counterbalance this benefit is uncertain . METHODS On the basis of ERSPC follow-up data , we used Microsimulation Screening Analysis ( MISCAN ) to predict the number of prostate cancers , treatments , deaths , and quality -adjusted life-years ( QALYs ) gained after the introduction of PSA screening . Various screening strategies , efficacies , and quality -of-life assumptions were modeled . RESULTS Per 1000 men of all ages who were followed for their entire life span , we predicted that annual screening of men between the ages of 55 and 69 years would result in nine fewer deaths from prostate cancer ( 28 % reduction ) , 14 fewer men receiving palliative therapy ( 35 % reduction ) , and a total of 73 life-years gained ( average , 8.4 years per prostate-cancer death avoided ) . The number of QALYs that were gained was 56 ( range , -21 to 97 ) , a reduction of 23 % from unadjusted life-years gained . To prevent one prostate-cancer death , 98 men would need to be screened and 5 cancers would need to be detected . Screening of all men between the ages of 55 and 74 would result in more life-years gained ( 82 ) but the same number of QALYs ( 56 ) . CONCLUSIONS The benefit of PSA screening was diminished by loss of QALYs owing to postdiagnosis long-term effects . Longer follow-up data from both the ERSPC and quality -of-life analyses are essential before universal recommendations regarding screening can be made . ( Funded by the Netherl and s Organization for Health Research and Development and others . ) BACKGROUND In 2008 , we reported that radical prostatectomy , as compared with watchful waiting , reduces the rate of death from prostate cancer . After an additional 3 years of follow-up , we now report estimated 15-year results . METHODS From October 1989 through February 1999 , we r and omly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy . Follow-up was complete through December 2009 , with histopathological review of biopsy and radical-prostatectomy specimens and blinded evaluation of causes of death . Relative risks , with 95 % confidence intervals , were estimated with the use of a Cox proportional-hazards model . RESULTS During a median of 12.8 years , 166 of the 347 men in the radical-prostatectomy group and 201 of the 348 in the watchful-waiting group died ( P=0.007 ) . In the case of 55 men assigned to surgery and 81 men assigned to watchful waiting , death was
Output:
| In addition , the implication s of adding either the PCA3 assay or the phi to clinical assessment were not clear .
Furthermore , the addition of the PCA3 assay or the phi to clinical assessment plus magnetic resonance imaging was not found to improve discrimination .
The results from the cost-effectiveness analyses indicated that using either the PCA3 assay or the phi in the NHS was not cost-effective .
The clinical benefit of using the PCA3 assay or the phi in combination with existing tests , scans and clinical judgement has not yet been confirmed .
The results from the cost-effectiveness analyses indicate that the use of these tests in the NHS would not be cost-effective . |
MS211877 | ***TASK*** the task is to summarize an input biomedical literature 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 Laparoscopic surgery challenges both the surgical novice and experienced open surgeon with unique psychomotor adaptations . Surgical skills assessment has historically relied on subjective opinion and case experience . Objective performance metrics have stimulated much interest in surgical education over the last decade and proficiency-based simulation has been proposed as a paradigm shift in surgical skills training . New assessment tools must be subjected to scientific validation . This study examined the construct validity of a hybrid laparoscopic simulator with in-built motion tracking technology . Methods Volunteers were recruited from four experience groups ( consultant surgeon , senior trainee , junior trainee , medical student ) . All subjects completed question naires and three tasks on the ProMIS laparoscopic simulator ( laparoscope orientation , object positioning , sharp dissection ) . Motion analysis data was obtained via optical tracking of instrument movements . Objective metrics included time , path length ( economy of movement ) , smoothness ( controlled h and ling ) and observer-recorded penalty scores . Results One hundred and sixty subjects completed at least one of the three tasks . Significant group differences were confirmed for number of years qualified , age and case experience . Significant differences were found between experts and novices in all three tasks . Sharp dissection was the strongest discriminator of four recognised laparoscopic skill groups : consultants outperformed students and juniors in all three performance metrics and objective penalty score ( p < 0.05 ) , and only accuracy of dissection did not distinguish them from senior trainees ( p = 0.261 ) . Seniors dissected faster , more efficiently and more accurately than juniors and students ( p < 0.05 ) . Conclusions ProMIS provides a construct valid laparoscopic simulator and is a feasible tool to assess skills in a cross-section of surgical experience groups . ProMIS has the potential to objective ly measure pre-theatre dexterity practice until an agreed proficiency level of dexterity is achieved . Future work should now examine whether training to expert criterion levels on ProMIS correlates with actual operative performance Background : To vali date the usefulness of virtual reality surgical simulators , we investigated the transfer of skills achieved by their use to real tasks . Methods : Thirty medical students underwent a pretest using a real laparoscopic trainer . They were then r and omized to the following three groups : group I received no training ; group II received training using the Minimal Invasive Surgical Trainer in Virtual Reality ( MIST-VR ) ; and group III received training using conventional training exercises . Each group then underwent a posttest . Using the Imperial College Surgical Assessment Device ( ICSAD ) , scores were generated for time taken , distance traveled , number of movements made , and speed of instrument movement . Results : Significant changes between the MIST-VR group ( group II ) and the conventionally trained group ( group III ) , were observed in the speed of movement of the left h and and the numbers of movements taken by each h and , when compared to the untrained group ( group I ) . Conclusion : The training of novices using MIST-VR yields quantifiable changes in skill that are transferable to a simple real task and are similar to the results achieved with conventional training Objective : To determine if prior training on the LapMentor ™ laparoscopic simulator leads to improved performance of basic laparoscopic skills in the animate operating room environment . Summary Background Data : Numerous influences have led to the development of computer-aided laparoscopic simulators : a need for greater efficiency in training , the unique and complex nature of laparoscopic surgery , and the increasing dem and that surgeons demonstrate competence before proceeding to the operating room . The LapMentor ™ simulator is expensive , however , and its use must be vali date d and justified prior to implementation into surgical training programs . Methods : Nineteen surgical interns were r and omized to training on the LapMentor ™ laparoscopic simulator ( n = 10 ) or to a control group ( no simulator training , n = 9 ) . Subjects r and omized to the LapMentor ™ trained to expert criterion levels 2 consecutive times on 6 design ated basic skills modules . All subjects then completed a series of laparoscopic exercises in a live porcine model , and performance was assessed independently by 2 blinded review ers . Time , accuracy rates , and global assessment s of performance were recorded with an interrater reliability between review ers of 0.99 . Results : LapMentor ™ trained interns completed the 30 ° camera navigation exercise in significantly less time than control interns ( 166 ± 52 vs. 220 ± 39 seconds , P < 0.05 ) ; they also achieved higher accuracy rates in identifying the required objects with the laparoscope ( 96 % ± 8 % vs. 82 % ± 15 % , P < 0.05 ) . Similarly , on the two-h and ed object transfer exercise , task completion time for LapMentor ™ trained versus control interns was 130 ± 23 versus 184 ± 43 seconds ( P < 0.01 ) with an accuracy rate of 98 % ± 5 % versus 80 % ± 13 % ( P < 0.001 ) . Additionally , LapMentor ™ trained interns outperformed control subjects with regard to camera navigation skills , efficiency of motion , optimal instrument h and ling , perceptual ability , and performance of safe electrocautery . Conclusions : This study demonstrates that prior training on the LapMentor ™ laparoscopic simulator leads to improved resident performance of basic skills in the animate operating room environment . This work marks the first prospect i ve , r and omized evaluation of the LapMentor ™ simulator , and provides evidence that LapMentor ™ training may lead to improved operating room performance OBJECTIVES To assess the face , content , and construct validity of the dV-Trainer . The dV-Trainer is a virtual reality simulator for the da Vinci Surgical System that is in beta development . METHODS Medical students , residents , and attending surgeons were enrolled in a prospect i ve , institutional review board-approved study . The subjects were prospect ively categorized as novice or experienced . Each subject completed 2 EndoWrist modules and 2 needle-driving modules . The performance was recorded using a built-in scoring algorithm . Each subject completed a question naire after finishing the modules . RESULTS The novice group ( n = 19 ) consisted of 3 students ( 16 % ) , 11 residents ( 58 % ) , and 5 attending surgeons ( 26 % ) . The novices had operated an average of 1.3 + /- 2.2 hours at the da Vinci console before using the simulator . The experienced subjects ( n = 7 ) had performed an average of 140 robotic cases ( range 30 - 320 ) . Experienced robotic surgeons outperformed novices in nearly all variables , including total score , total task time , total instrument motion , and number of instrument collisions ( P < .01 ) . All experienced surgeons ranked the simulator as useful for training and agreed with incorporating the simulator into a residency curriculum . The virtual reality and instrumentation achieved acceptability . The needle-driving modules did not exceed the acceptability threshold . CONCLUSIONS The results of the present study have shown that the dV-Trainer has face , content , and construct validity as a virtual reality simulator for the da Vinci Surgical System . The needle-driving modules need to be refined . Studies are underway to assess the concurrent and predictive criterion validity . The dV-Trainer could become a beneficial training simulator for robotic surgery OBJECTIVES : Computer-based colonoscopy simulation ( CBCS ) is being utilized in endoscopy training without supporting evidence that it improves patient-based colonoscopy performance . The goal of this pilot study was to determine if CBCS training improves gastroenterology ( GI ) fellows ' patient-based colonoscopy skills . METHODS : Competency at colonoscopy among 4 novice GI fellows who completed a 6-h CBCS curriculum was compared with 4 novice fellows who were not CBCS-trained . Measurements of competency were rendered by supervising faculty by recording “ insertion time,”“depth of unassisted insertion,”“independent procedure completion,”“ability to identify endoscopic l and marks,”“inserts in a safe manner,”“adequately visualizes mucosa on withdrawal , ” and “ responds appropriately to patient discomfort ” with each colonoscopy . RESULTS : Simulator-trained fellows outperformed traditionally trained fellows during their initial 15 colonoscopies in all performance aspects except “ insertion time ” ( pp < 0.05 ) . Simulator-trained fellows inserted the endoscope significantly further and reached the cecum independently nearly twice as often during this early training period . Three parameters ( “ depth of insertion,”“independent completion , ” and “ ability to identify l and marks ” ) demonstrated a continued advantage out to 30 colonoscopies . Beyond 30 procedures , there was no difference in the performance of the two groups . CONCLUSION : In this pilot study , a 6-h CBCS curriculum provides an early training advantage by enhancing competency at the early stages of patient-based colonoscopy . These advantages are negligible after approximately 30 patient-based procedures . CBCS-enhanced training may allow faculty to be more efficient with their colonoscopy practice This research represents a r and omized blinded pilot study to evaluate the acceptability and validity of a da Vinci robotic virtual reality simulator platform tested during a pediatric robotic surgery post-graduate course during the annual American Urological Association meeting in June 2007 . Course enrollees performed robotic skills tasks on the da Vinci robot and on an offline dV-Trainer and course participant demographic and performance data were analyzed . The majority of learners believed that VR simulation is useful for teaching robotic skills , they believed that the offline trainer can teach robotic skills comparable to a dry lab robotics skills station , and the offline trainer was able to discriminate between experts and novices of robotic surgery , thereby meeting criteria for face , content , and construct validities . This is the first reported acceptability study of a VR robotic surgery simulator as compared to the da Vinci robot system
Output:
| The Mimic dV-Trainer ( ® ) , ProMIS ( ® ) , SimSurgery Educational Platform ( ® ) ( SEP ) and Intuitive systems have shown face , content and construct validity .
The Robotic Surgical SimulatorTM system has only been face and content vali date d. All of the simulators except SEP have shown educational impact .
Virtual reality simulators were shown to be effective training tools for junior trainees .
Simulation training holds the greatest potential to be used as an adjunct to traditional training methods to equip the next generation of robotic surgeons with the skills required to operate safely .
There is no evidence to suggest one type of simulator provides more effective training than any other . |
MS211878 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND We evaluated the effects of cytochrome P450 3A4 ( CYP3A4 ) induction and inhibition on steady-state pharmacokinetics of the components of a novel oral contraceptive ( OC ) containing estradiol valerate ( E₂V ) and dienogest ( DNG ) . STUDY DESIGN CYP3A4 induction was assessed in an open-label , one-arm study . Sixteen healthy postmenopausal women received E₂V 2 mg/DNG 3 mg ( days 1 - 17 ) and concomitant rifampicin ( 600 mg , days 12 - 16 ) . Ratios of the area under the serum concentration-time curve between 0 and 24 h [ AUC(0 - 24 h ) ] and maximum serum concentration ( C(max ) ) of E₂ and DNG on days 17 and 11 ( after and before rifampicin intervention ) are presented . CYP3A4 inhibition was investigated in an open-label , parallel-group study in 24 healthy postmenopausal women receiving E₂V 2 mg/DNG 3 mg ( days 1 - 14 ) and concomitant ketoconazole ( 400 mg , n=12 ) or erythromycin ( 500 mg three times daily , n=12 ) on days 8 - 14 . Mean ratios of AUC(0 - 24 h ) and C(max ) of E₂ and DNG on days 7 and 14 are presented . RESULTS Concomitant administration of rifampicin decreased systemic drug exposure and yielded geometric mean ratios for E₂C(max ) and AUC(0 - 24 h ) of 75 % and 56 % , respectively . Corresponding mean ratios for DNG were 48 % and 17 % , respectively . Ketoconazole coadministration increased systemic drug exposure and yielded ratios of E₂ of 165 % and 157 % , respectively , and ratios of DNG of 194 % and 286 % , respectively . Erythromycin coadministration also result ed in increased mean C(max ) and AUC(0 - 24 h ) of both E₂ and DNG . Geometric mean ratios of C(max ) and AUC(0 - 24 h ) for E₂ were 151 % and 133 % , respectively . Corresponding ratios for DNG were 133 % and 162 % , respectively . CONCLUSIONS Significant drug-drug interactions are apparent when CYP3A4 modulators are coadministered with the components of a novel OC containing E₂V/DNG . Coadministration of CYP3A4 modulators should be avoided where possible , and another type of contraception should be used when coadministration of CYP3A4 inducers like rifampicin is unavoidable The effect of ciprofloxacin , a new broad-spectrum quinolone derivative , on concomitant oral contraceptive steroids has been studied in a double-blind cross-over placebo-controlled r and omized trial . Ten healthy women using long-term oral contraceptive steroids received either ciprofloxacin 500 mg BID or placebo during two consecutive cycles . Therapy was continued for seven days from the first day of contraceptive treatment . FSH , LH and oestradiol blood levels were repeatedly determined to monitor contraceptive steroid efficacy . A seven-day treatment with ciprofloxacin did not affect steroid treatment outcome and appears to be safe in women using this contraceptive method The possibility of escape ovulation in women using a fluoroquinolone ofloxacin for antibacterial treatment at a dose of 200 mg twice daily for 7 days when taking a combined oral contraceptive ( Microgynon , 150 μg levonorgestrel and 30 μg ethinyl estradiol ) was studied in 20 women . By using a placebocontrolled , rendomized , cross-over design 6 contraceptive pill cycles were followed . Follicle-stimulating hormone and estradiol concentrations were measured on tablet days 5–8 , 19–21 ; progesterone was assayed on days 19–21 during treatment with ofloxacin or placebo . Ultrasonographical investigations for measurements of the number and diameter of ovarian follicles were performed on one of days 5–10 , 11–17 , 18–24 , 25–28 . No indications of ovulation during ofloxacin medication were detected . It is concluded that alternative contraceptive pre caution s should not be needed when ofloxacin is prescribed for patients taking oral contraceptives . ResuméOn a étudié la possibilité d'une ovulation fortuite chez une vingtaine de femmes utilisant la fluoroquinoline ofloxacine pour un traitement antibactérien , selon une dose de 200 mg deux fois par jour pendant 7 jours , en même temps que le contraceptif oral Microgynon ( 150 μg de lévonorgestrel et 30 μg d'éthinyl oestradiol ) . A l'aide d'un contrôle croisé , r and omisé avec placebo , on a suivi 6 cycles pendant lesquels la pilule avait été utilisée . On a mesuré les concentrations de gonadostimuline ( FSH ) et d'oestradiol aux jours 5–8 et 19–21 de la prise des pilules , et on a analysé la progestérone aux jours 19–21 soit durant le traitement à l'ofloxacine soit durant la prise du placebo . Par explorations échographiques , on a mesuré le nombre et le diamètre des follicules ovariens au cours de l'un des jours 5 à 10 , 11 à 17 , 18 à 24 , 25 à 28 . Aucune indication d'ovulation n'a été décelée pendant l'administration de l'ofloxacine . On peut en conclure qu'il ne devrait pas être nécessaire de prendre d'autres pré caution s contraceptives lorsque l'ofloxacine est prescrit à des femmes utilisant les contraceptifs orauxResumenSe estudió en 20 mujeres la posibilidad de ovulación de escape en mujeres a las que se administró una fluoroquinolona , ofloxacin , como tratamiento antibacteriano a una dosis de 200 mg dos veces al día durante 7 días al tomar un anticonceptivo oral combinado , Microgynon ( 150 μg de levonorgestrel y 30 μg de etinilestradiol ) . Utiliz and o un diseño cruzado , aleatorizado y controlado por placebo , se examinaron 6 ciclos con píldora anticonceptiva . Se midieron las concentraciones de folicoestimulina y estradiol en los días de píldora 5–8 , 19–21 ; la progesterona se examinó en los días 19–21 durante et tratamiento con ofloxacin o placebo . Se realizaron investigaciones ecográficas para medir el número y tamaño de los folículos ováricos en uno de los días 5–10 , 11–17 , 18–24 , 25–28 . No se detectó ninguna indicación de ovulación durante la medicación con ofloxacin . Se llegó a la conclusión de que no se necesitan precauciones anticonceptivas adicionales cu and o a las pacientes que toman anticonceptivos orales se les prescribe ofloxacin In view of the considerable debate concerning the possible failure of contraception in women taking broad spectrum antibiotics , we have examined a group of 12 women aged 22 - 32 in a controlled study . Each woman had been on long-term therapy with oral contraceptive steroids ( OCS ) containing ethynylestradiol ( EE2 ) and levonorgestrel ( Ng ) for at least 6 months and all were in good general health . Blood sample s were taken about 11.0 hours after dosing with their OCS on days 5 , 6 , 7 and 8 of their contraceptive cycle , for measurement of EE2 , Ng , FSH and LH by radioimmunoassay . In addition blood sample s were taken on days 19 , 20 and 21 of the contraceptive cycle for assay of progesterone concentrations in plasma . The study was repeated in the next cycle of use of their OCS during which they took temafloxacin , a broad spectrum quinolone antibiotic in a dose of 600 mg twice daily for 7 days starting on day 1 of the cycle . All women completed the study satisfactorily as judged by diary cards , tablet counts and plasma temafloxacin concentrations . In the early part of the study some nausea and headaches were seen due to taking temafloxacin on an empty stomach but these effects were not seen when the antibiotic was later given with food . There was no evidence of any interaction between temafloxacin and the OCS . The plasma concentration of EE2 was 61.4 + /- 21.1 pg/ml in the control cycle and 68.5 + /- 26.6 pg/ml in the temafloxacin cycle . ( ABSTRACT TRUNCATED AT 250 WORDS Objective To use a novel , sensitive study design to detect a potential oral contraceptive ( OC ) and dirithromycin drug interaction by assessing the pharmacokinetics of the ethinyl estradiol ( E2 ) component of a common OC and the potential failure of OC effectiveness . Methods In this nonblinded study , 20 healthy women using Ortho Novum 7/7/7 - 28 were selected for a three-OC-cycle study . Baseline measures included E2 and progesterone serum levels on days 21 , 23 , 25 , and 27 of cycle one and days 1 , 3 , 5 , and 7 of cycle two . During cycle two , 24-hour blood sampling and radioimmunoassay analysis for ethinyl E2 pharmacokinetics were performed on day 8 and pelvic ultrasound on day 13 . Oral dirithromycin 500 mg/day for 14 days began on day 21 of cycle 2 . After starting dirithromycin , cycle two and three serum E2 , progesterone , and serial ethinyl E2 levels and pelvic ultrasound replicated the baseline schedule . Ovulation was assumed if E2 concentration was greater than 50 pg/mL , progesterone concentration was greater than 3 ng/mL , or if an ovarian cyst greater than 10 mm was present on ultrasound . Results Pharmacokinetic analysis demonstrated a small ( 7.6 % ) but statistically significant decrease ( P = .03 ) in the mean ethinyl E2 24-hour area under the curve and an increase in apparent oral clearance . No woman ovulated , based on E2 levels and progesterone concentrations or ultra sound . Conclusion Dirithromycin increased the apparent oral clearance of ethinyl E2 . The clinical importance of the interaction may be negligible because no woman ovulated or had compromised OC effectiveness in this small series WHAT IS KNOWN AND OBJECTIVE Ulipristal acetate ( UPA ) is a novel selective progesterone receptor modulator for the treatment of benign gynaecological conditions such as uterine myoma . In vitro , it is mainly metabolized by the cytochrome P450 isoenzyme CYP3A4 and to a small extent by CYP1A2 and CYP2D6 . Erythromycin , a macrolide antibiotic , has been shown to be a moderate CYP3A4 inhibitor . Thus , the aim of this study was to determine the effects of erythromycin at steady-state concentrations on the pharmacokinetics of UPA . Effects on the pharmacokinetics of the mono-demethylated metabolite of UPA ( PGL4002 ) were also evaluated . METHODS This was a non-r and omized , single-sequence , two-period , open , single-dose study in 18 healthy female subjects . Subjects received oral UPA ( 20 mg ) once daily on days 1 and 13 and twice-daily erythromycin propionate administrations ( 500 mg ) from days 9 through 17 . RESULTS Geometric mean Cmax and AUCs of UPA were increased by 24 % [ geometric mean ratio point estimate ( 90 % CI ) : 1·24 ( 1·01 - 1·52 ) ] and + 224 % and + 227 % [ geometric mean ratio point estimates ( 90 % CI ) : AUC0-t 3·24 ( 2·75 - 3·83 ) and AUC0-∞ ( 3·27 ( 2·79 - 3·83 ) ] , respectively , with no effect on median tmax or t1/2 . Geometric mean Cmax of PGL4002 was decreased by 47 % [ geometric mean ratio point estimate ( 90 % CI ) : 0·523 ( 0·44 - 0·62 ) ] , but AUCs were increased by + 62 % and + 66 % [ geometric mean ratio point estimates ( 90 % CI ) : AUC0-t 1·62 ( 1·43 - 1·85 ) and AUC0-∞ by 1·66 ( 1·47 - 1·88 ) ] , respectively , with no effect on median tmax . However , geometric mean t1/2.doubled from 24 h to 48 h. No subject was discontinued from the
Output:
| RESULTS : Study quality ranged from good to poor and addressed only oral contraceptive pills , emergency contraception pills , and the combined vaginal ring .
No differences in ovulation suppression or breakthrough bleeding were observed in any study that combined hormonal contraceptives with any antibiotic .
No significant decreases in any progestin pharmacokinetic parameter occurred during co‐administration with any antibiotic .
: Evidence from clinical and pharmacokinetic outcomes studies does not support the existence of drug interactions between hormonal contraception and non‐rifamycin antibiotics .
Most women can expect no reduction in hormonal contraceptive effect with the concurrent use of non‐rifamycin antibiotics |
MS211879 | ***TASK*** the task is to summarize an input biomedical literature 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 Increasing clinician awareness of racial disparities and improving communication may enhance diabetes care among black patients . OBJECTIVE To evaluate the effect of cultural competency training and performance feedback for primary care clinicians on diabetes care for black patients . DESIGN Cluster r and omized , controlled trial conducted between June 2007 and May 2008 . ( Clinical Trials.gov registration number : NCT00436176 ) SETTING : 8 ambulatory health centers in eastern Massachusetts . PARTICIPANTS 124 primary care clinicians caring for 2699 ( 36 % ) black and 4858 ( 64 % ) white diabetic patients . INTERVENTION INTERVENTION clinicians received cultural competency training and monthly race-stratified performance reports that highlighted racial differences in control of hemoglobin A(1c ) ( HbA(1c ) ) and low-density lipoprotein ( LDL ) cholesterol levels and blood pressure . MEASUREMENTS Clinician awareness of racial differences in diabetes care and rates of achieving clinical control targets among black patients at 12 months . RESULTS White and black patients differed significantly in baseline rates of achieving an HbA(1c ) level less than 7 % ( 46 % vs. 40 % ) , an LDL cholesterol level less than 2.59 mmol/L ( < 100 mg/dL ) ( 55 % vs. 43 % ) , and blood pressure less than 130/80 mm Hg ( 32 % vs. 24 % ) ( all P < 0.050 ) . At study completion , intervention clinicians were significantly more likely than control clinicians to acknowledge the presence of racial disparities in the 8 health centers as a whole ( 82 % vs. 59 % ; P = 0.003 ) , within their local health center ( 70 % vs. 51 % ; P = 0.020 ) , and among their own patients ( 63 % vs. 43 % ; P = 0.037 ) . Black patients of clinicians in the intervention and control groups did not differ at 12 months in rates of controlling HbA(1c ) level ( 48 % vs. 45 % ; P = 0.24 ) , LDL cholesterol level ( 48 % vs. 49 % ; P = 0.40 ) , or blood pressure ( 23 % vs. 25 % ; P = 0.47 ) . LIMITATION 11 % of primary care teams did not attend cultural competency training sessions . CONCLUSION The combination of cultural competency training and race-stratified performance reports increased clinician awareness of racial disparities in diabetes care but did not improve clinical outcomes among black patients BACKGROUND Complete diagnostic evaluation or CDE ( i.e. , colonoscopy or combined flexible sigmoidoscopy plus barium enema X-ray ) is often not performed for persons with an abnormal screening fecal occult blood test ( FOBT+ ) result . METHOD This study evaluated the impact of a reminder-feedback and educational outreach intervention on primary care practice CDE recommendation and performance rates . Four hundred seventy primary care physicians ( PCPs ) in 318 practice s participated in the study . Patients were mailed an FOBT kit annually as part of a screening program . Practice s were r and omly assigned to a Control Group ( N = 198 ) or an Intervention Group ( N = 120 ) . During an 18-month pre-r and omization period and a 9-month post-r and omization period , 2992 screening FOBT+ patients were identified . Intervention practice s received the screening program and the intervention . Control practice s received only the screening program . Study outcomes were baseline-adjusted CDE recommendation and performance rates . RESULTS At baseline , about two-thirds of FOBT+ patients received a CDE recommendation , and about half had a CDE performed . At endpoint , CDE recommendation and performance rates were both significantly higher for the Intervention as compared to the Control practice s ( OR = 2.28 ; 95 % CI : 1.37 , 3.78 , and OR = 1.63 ; 95 % CI : 1.06 , 2.50 , respectively ) . CONCLUSIONS The reminder-feedback plus educational outreach intervention significantly increased CDE recommendation and performance We performed a r and omized , prospect i ve study to evaluate the use of a written feedback system in reducing the intraoperative costs of drugs and supplies used by anesthesiologists . Over 6 mo , 27 anesthesiology residents were r and omized to feedback and control groups for their rotations in neurosurgical anesthesia . We recorded the cost of drugs and supplies for three procedures : carotid endarterectomy , lumbar decompression , and cervical decompression . For each study case , members of the feedback group received a written cost analysis showing their performance relative to the departmental average . Members of the feedback group had significantly lower costs for carotid endarterectomies ( $ 79.98 + /- $ 15.20 vs $ 97.59 + /- $ 21.53 ) and for lumbar decompressions ( $ 56.72 + /- $ 16.49 vs $ 76.05 + /- $ 20.11 ) . The source of savings included lower use rates for propofol and etomi date and for patient warming devices . Analysis of data from recovery areas revealed a trend toward lower patient temperature in lumbar procedures performed by the feedback group . Three months after the feedback period , we collected a follow-up data set in the absence of feedback . This revealed a significant rebound in overall cost by the feedback group for both carotid endarterectomies and lumbar surgery . Implication s : This is the first r and omized , prospect i ve evaluation of a cost management system in anesthesia . Using resident anesthesiologists , we showed that the written feedback of individualized performance data can be used to lower the overall cost of intraoperative drugs and supplies used for an anesthetic in the absence of m and ated clinical guidelines . ( Anesth Analg 1998;86:510 - 5 Although numerous utilization review s of serum digoxin assays have demonstrated the positive impact of therapeutic drug monitoring , to our knowledge , the question of whether the withdrawal of such a program would reverse the effect has not been addressed . The current study employed a prospect i ve , r and omized , crossover design to evaluate this question and document the cost savings . There were 196 serum digoxin assays performed in the 207 patients . It was found that a continuous therapeutic drug-monitoring program was warranted since , after its withdrawal , there was a deterioration in audit criteria performance . Reimplementation of the therapeutic drug-monitoring program result ed in a significant decrease in the average number of assays requested per patient ( from 1.41 to 0.73 ) and an improvement in audit criteria performance OBJECTIVE : To determine whether residents perceived oral , face-to-face feedback about their continuity clinic performance as better than a similar , written version . DESIGN : Single-blind , r and omized controlled trial . SETTING : Two university-based , internal medicine residency clinics . PARTICIPANTS : All 68 internal medicine and combined program ( medicine-pediatrics , medicine-psychiatry , medicine-neurology , and preliminary year ) residents and their clinic preceptors . MEASUREMENTS AND MAIN RESULTS : Residents at each program were separately r and omized to oral or written feedback sessions with their clinic preceptors . The oral and written sessions followed similar , structured formats . Both groups were later sent question naires about aspects of the clinic . Sixty-five ( 96 % ) of the residents completed the question naire . Eight of the 19 questions dealt with aspects of feedback . A feedback scale was developed from the survey responses to those eight questions ( α=.86 ) . There were no significant differences in the responses to individual questions or in scale means ( p>.20 ) between the two feedback groups . When each university was analyzed separately , one had a higher scale mean ( 3.10 vs 3.57 , p=.047 ) , but within each university , there were no differences between the oral and written feedback groups ( p>.20 ) . CONCLUSIONS : No differences were observed between the oral and written feedback groups . In attempting to provide better feedback to their residents , medical educators may better apply their efforts to other aspects , such as the frequency of their feedback , rather than the form of its delivery Due to possible method ological and practical problems , many research ers refrain from using a r and omized controlled trial design to evaluate procedures already embedded in routine health care . We performed a r and omized controlled trial on the effects of routine individual feedback on test ordering behavior of family physicians . The trial started after 4 years of feedback and lasted for 2.5 years . With some adaptations a r and omized trial proved to be possible . In evaluating health-care procedures that can not be blinded in a traditional way , asking full and study -specific informed consent may conflict with the validity of the design . In such studies , an alternative procedure is to be considered . Our trial , with doctors as study subjects , was held on an already accepted routine procedure ( feedback ) . This made it possible to refrain from obtaining study -specific informed consent . Consequently , a Hawthorne effect and contamination of the trial arms through information leakage could be avoided . Justification and general criteria for not obtaining full and study -specific informed consent are worked out . In health-care research on the performance of doctors or on interventions into the quality of care , obtaining a general informed consent in advance is an acceptable alternative approach OBJECTIVE To evaluate the impact of systematic patient evaluation and patient and provider feedback on the processes and intermediate outcomes of diabetes care in Independent Practice Association model internal medicine practice s. RESEARCH DESIGN AND METHODS Nine practice s providing care to managed care patients were r and omly assigned as intervention or comparison sites . Intervention-site subjects had Annual Diabetes Assessment Program ( ADAP ) assessment s ( HbA(1c ) , blood pressure , lipids , smoking , retinal photos , urine microalbumin , and foot examination ) at years 1 and 2 . Comparison-site subjects had ADAP assessment s at year 2 . At Intervention sites , year 1 ADAP results were review ed with subjects , mailed to providers , and incorporated into electronic medical records with guideline -generated suggestions for treatment and follow-up . Medical records were evaluated for both groups for the year before both the year 1 and year 2 ADAP assessment s. Processes and intermediate outcomes were compared using linear and logistic mixed hierarchical models . RESULTS Of 284 eligible subjects , 103 of 173 ( 60 % ) at the Intervention sites and 71 of 111 ( 64 % ) at the comparison sites participated ; 83 of 103 ( 81 % ) of the intervention-site subjects returned for follow-up at year 2 . Performance of the six recommended assessment s improved in intervention-site subjects at year 2 compared with year 1 ( 5.8 vs. 4.3 , P = 0.0001 ) and compared with comparison-site subjects at year 2 ( 4.2 , P = 0.014 ) . No significant changes were noted in intermediate outcomes . CONCLUSIONS The ADAP significantly improved processes of care but not intermediate outcomes . Additional interventions are needed to improve intermediate outcomes OBJECTIVE To assess the effects of a facilitator enhanced multifaceted intervention to implement a locally adapted guideline on the shared care for people with type 2 diabetes . METHODS During 1 year a cluster-r and omized trial was performed in 30 general practice s. In the intervention group , nurse facilitators enhanced guideline implementation by analysing barriers to change , introducing structured care , training practice staff and giving performance feedback . Targets for HbA1c% , systolic blood pressure as well as indications for angiotensin converting enzyme/angiotensin receptor blocking agent prescription differed from the national guidelines . In the control group , GPs were asked to continue the care for people with diabetes as usually . Generalized estimating equations were used to control for the clustered design of the study . RESULTS In the intervention group , more people were seen on a 3-monthly basis ( 88 % versus 69 % , P < 0.001 ) and more blood pressure and bodyweight measurements were performed every 3 months ( blood pressure 83 % versus 66 % , P < 0.001 and bodyweight 78.9 % versus 48.5 % , P < 0.001 ) . Apart from a marginal difference in mean cholesterol , differences in HbA1c% , blood pressure , body mass index and treatment satisfaction were not significant . CONCLUSION Multifaceted implementation of locally adapted shared care guidelines did improve the process of diabetes care but hardly changed intermediate outcomes . In the short term , local adaptation of shared care guidelines does not improve the cardiovascular risks of people with type 2 diabetes Improved pneumococcal vaccine ( PPV ) immunization for seniors is a national goal of the Medicare program . This study examined whether adding a simple telephone follow-up to an existing mailed physician performance feedback under the Medicare program would increase the impact on billed pneumococcal immunizations . Medicare fee-for-service cl aims data were used to select New York primary care physicians with high volume ( n = 732 ) or African-American serving ( n = 329 ) practice s. All practice s received mailed feedback on their 1999 Medicare practice specific PPV coverage rates , along with educational material s and offers of assistance . Practice s were also r and omized to receive telephone calls directing attention to the mailing and further promoting improvements in PPV coverage or no active follow-up . Physicians r and omized to telephone follow-up showed significantly higher rates of practice specific PPV coverage in 2000 than those receiving the routine mailing only , and 27 % vs. 17 % ( p = 0.01 ) of high volume physicians and 34 % vs.
Output:
| Multivariable meta-regression indicated that feedback may be more effective when baseline performance is low , the source is a supervisor or colleague , it is provided more than once , it is delivered in both verbal and written formats , and when it includes both explicit targets and an action plan .
In addition , the effect size varied based on the clinical behaviour targeted by the intervention .
Audit and feedback generally leads to small but potentially important improvements in professional practice .
The effectiveness of audit and feedback seems to depend on baseline performance and how the feedback is provided . |
MS211880 | ***TASK*** the task is to summarize an input biomedical literature 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: Substantial progress has been made in the awareness , treatment , and prevention of cardiovascular disease ( CVD ) in women since the first women-specific clinical recommendations for the prevention of CVD were published by the American Heart Association ( AHA ) in 1999.1 The myth that heart disease is a “ man 's disease ” has been debunked ; the rate of public awareness of CVD as the leading cause of death among US women has increased from 30 % in 1997 to 54 % in 2009.2 The age-adjusted death rate result ing from coronary heart disease ( CHD ) in females , which accounts for about half of all CVD deaths in women , was 95.7 per 100 000 females in 2007 , a third of what it was in 1980.3,4 Approximately 50 % of this decline in CHD deaths has been attributed to reducing major risk factors and the other half to treatment of CHD including secondary preventive therapies.4 Major r and omized controlled clinical trials such as the Women 's Health Initiative have changed the practice of CVD prevention in women over the past decade.5 The investment in combating this major public health issue for women has been significant , as have the scientific and medical achievements . Despite the gains that have been made , considerable challenges remain . In 2007 , CVD still caused ≈1 death per minute among women in the United States.6 These represent 421 918 deaths , more women 's lives than were cl aim ed by cancer , chronic lower respiratory disease , Alzheimer disease , and accidents combined.6 Reversing a trend of the past 4 decades , CHD death rates in US women 35 to 54 years of age now actually appear to be increasing , likely because of the effects of the obesity epidemic.4 CVD rates in the United States are significantly higher for black females compared with their white counterparts ( 286.1/100 000 versus Introduction Isometric resistance training has repeatedly shown to be an effective exercise modality in lowering resting blood pressure ( BP ) , yet associated mechanisms and sex differences in the response to training remain unclear . Exploration into potential sex differences in the response to isometric resistance training is necessary , as it may allow for more optimal and sex-based exercise prescription , thereby maximizing the efficacy of the training intervention . Purpose Therefore , we investigated , in normotensives , whether sex differences exist in the response to isometric h and grip ( IHG ) training . Methods Resting BP and endothelium-dependent vasodilation ( brachial artery flow-mediated dilation ; FMD ) were assessed in 11 women ( 23 ± 4 years ) and 9 men ( 21 ± 2 years ) prior to and following 8 weeks of IHG training ( four , 2-min unilateral contractions at 30 % of maximal voluntary contraction ; 3 days per week ) . Results Main effects of time were observed ( all P < 0.05 ) , whereby IHG training reduced systolic BP ( Δ 8 ± 6 mmHg ) , diastolic BP ( Δ 2 ± 3 mmHg ) , mean arterial pressure ( Δ 4 ± 3 mmHg ) , and pulse pressure ( Δ 5 ± 7 mmHg ) , accompanied by increases in absolute ( Δ 0.09 ± 0.15 mm ) and relative ( Δ 2.4 ± 4.1 % ) brachial artery FMD ; however , no significant sex differences were observed in the magnitude of post-training change in any variable assessed ( all P > 0.05 ) . Conclusion IHG training effectively lowers resting BP and improves endothelium-dependent vasodilation in men and women , without significant sex differences in the magnitude of response Isometric HG ( h and grip ) training lowers resting arterial BP ( blood pressure ) , yet the mechanisms are elusive . In the present study , we investigated improved systemic endothelial function as a mechanism of arterial BP modification following isometric HG training in normotensive individuals . This study employed a within-subject repeated measures design primarily to assess improvements in BA FMD ( brachial artery flow-mediated dilation ; an index of endothelium-dependent vasodilation ) , with the non-exercising limb acting as an internal control . Eleven subjects performed four 2-min unilateral isometric HG contractions at 30 % of maximal effort , three times per week for 8 weeks . Pre- , mid- and post-training resting ABP and BA FMD ( exercised arm and non-exercised arm ) were measured via automated brachial oscillometry and ultrasound respectively . BA FMD ( normalized to the peak shear rate experienced in response to the reactive hyperaemic stimulus ) remained unchanged [ exercised arm , 0.029+/-0.003 to 0.026+/-0.003 to 0.029+/-0.004%/s(-1 ) ( pre- to mid- to post-training respectively ) ; non-exercised arm , 0.023+/-0.003 to 0.023+/-0.003 to 0.024+/-0.003%/s(-1 ) ( pre- to mid- to post-training respectively ) ; P=0.22 ] . In conclusion , improved systemic endothelial function is unlikely to be responsible for lowering arterial BP in this population Aerobic and isometric training have been shown to reduce resting blood pressure , but simultaneous aerobic and isometric training have not been studied . The purpose of this study was to compare the changes in resting systolic ( SBP ) , diastolic ( DBP ) , and mean arterial blood pressure ( MAP ) after 6 weeks of either ( i ) simultaneous walking and isometric h and grip exercise ( WHG ) , ( ii ) walking ( WLK ) , ( iii ) isometric h and grip exercise ( IHG ) , or control ( CON ) . Forty-eight healthy sedentary participants ( age 20.7 ± 1.7 yrs , mass 67.2 ± 10.2 kg , height 176.7 ± 1.2 cm , male n = 26 , and female n = 22 ) were r and omly allocated , to one of four groups ( n = 12 in each ) . Training was performed 4 × week−1 and involved either treadmill walking for 30 minutes ( WLK ) , h and grip exercise 3 × 10 s at 20 % MVC ( IHG ) , or both performed simultaneously ( WHG ) . Resting SBP , DBP , and MAP were recorded at rest , before and after the 6-week study period . Reductions in resting blood pressure were significantly greater in the simultaneous walking and h and grip group than any other group . These results show that simultaneous walking and h and grip training may have summative effects on reductions in resting blood pressure Aerobic endurance exercise ( AEX ) is an effective treatment in the prevention and management of high blood pressure ( BP ) . Growing evidence suggests potential benefits from isometric h and grip ( IHG ) exercise , which may promote similar or even larger reductions in BP than AEX . We compared the effects of home-based AEX and home-based IHG on BP . Sixty healthy individuals ( 31 men ; mean age , 33.1 years ; mean BP , 126.9 ± 1.6/84.7 ± 1.1 mm Hg ) were r and omized to IHG , AEX , or a control group . Both exercise interventions were performed in the home environment . The IHG group performed daily 4 × 2 minutes sustained grips at 30 % of maximal volitional contraction . Participants in the AEX group were advised to perform at least 150 min/wk of aerobic exercise at moderate intensity . Outcome measurements were assessed at baseline and 8 weeks of follow-up . Compared with the control group , AEX result ed in a larger reduction in ambulatory BP ; both AEX and IHG exercise tended to induce larger reductions in office systolic BP , and office diastolic BP was significantly more reduced after AEX but not IHG exercise . Responses to training were not significantly different between both the exercise interventions . Eight weeks of home-based AEX results in significant reductions in both ambulatory BP and office BP in healthy adults , whereas IHG reduces only office BP Introduction : Several established tools are available to assess study quality and reporting of r and omized controlled trials ; however , these tools were design ed with clinical intervention trials in mind . In exercise training intervention trials some of the traditional study quality criteria , such as participant or research er blinding , are extremely difficult to implement . Methods : We developed the Tool for the assEssment of Study qualiTy and reporting in EXercise ( TESTEX ) – a study quality and reporting assessment tool , design ed specifically for use in exercise training studies . Our tool is a 15-point scale ( 5 points for study quality and 10 points for reporting ) and addresses previously unmentioned quality assessment criteria specific to exercise training studies . Results : There were no systematic differences between the summated TESTEX scores of each observer [ H(2 ) = 0.392 , P = 0.822 ] . There was a significant association between the summated TESTEX scores of the three observers , with almost perfect agreement between observers 1 and 2 [ intra-class correlation coefficient ( ICC ) = 0.93 , 95 % confidence interval ( CI ) 0.82–0.97 , P < 0.001 ] , observers 1 and 3 ( ICC = 0.96 , 95 % CI 0.89–0.98 , P < 0.001 ) and observers 2 and 3 ( ICC = 0.91 , 95 % CI 0.75–0.96 , P < 0.001 ) . Conclusions : The TESTEX scale is a new , reliable tool , specific to exercise scientists , that facilitates a comprehensive review of exercise training trials OBJECTIVE A short-term isometric exercise protocol was tested in ten hypertensive individuals to determine its efficacy as a high blood pressure-reducing intervention . DESIGN The study was a prospect i ve case study of 10 hypertensive individuals ( 8 men , 2 woman , mean age = 52 + 5 years ) who underwent six weeks of isometric exercise training ( three sessions/week ) . METHODS Blood pressure , blood lipids and markers of oxidative stress were monitored before , during and following the isometric intervention . Electron spin resonance spectroscopy was used to directly measure radicals in the blood sample s. RESULTS After six weeks , systolic blood pressure decreased an average 13 mm Hg ( p < 0.05 ) from a mean blood pressure of 146 to 133 mm Hg , a level that is below the usual 140 mm Hg hypertension threshold . Blood lipids were unchanged , but markers of oxidative stress were affected , with a dramatic decrease in exercise-induced oxygen centered radicals ( -266 % ) , ( p < 0.05 ) and an increased resting whole blood glutathione : oxidized glutathione ( + 61 % ) in hypertensive adults following six weeks of isometric exercise . CONCLUSION Six weeks of isometric exercise training was effective in lowering systolic but not diastolic blood pressure in pre-hypertensive and hypertensive individuals , and enhanced antioxidant protection is a likely underlying mechanism Introduction : Hypertension is a major risk factor contributing to cardiovascular disease , which is the number one cause of deaths worldwide . Although antihypertensive medications are effective at controlling blood pressure , current first-line treatment for hypertension is nonpharmacological lifestyle modifications . Recent studies indicate that isometric resistance training ( IRT ) may also be effective for assisting with blood pressure management . The aim of this study was to determine the efficacy of IRT for blood pressure management and the suitability of a low-intensity working control group . Methods : Forty hypertensive individuals , aged between 36 and 65 years , conducted IRT for 8 weeks . Participants were r and omized into 2 groups , working at an intensity of either 5 % or 30 % of their maximum voluntary contraction . Participants performed 4 × 2 minute isometric h and grip exercises with their nondominant h and , each separated by a 3-minute rest period , 3 days a week . Results : Blood pressure measurements were conducted at baseline and at the end of the protocol using a Finometer . Eight weeks of isometric resistance training result ed in a 7-mmHg reduction of resting systolic blood pressure ( SBP ) ( 136 ± 12 to 129 ± 15 ; P = 0.04 ) in the 30 % group . Reductions of 4 mmHg were also seen in mean arterial pressure ( MAP ) ( 100 ± 8 to 96 ± 11 ; P = 0.04 ) in the 30 % group . There were no statistically significant reductions in diastolic blood pressure for the 30 % group , or any of the data for the 5 % group . Conclusion : Isometric resistance training conducted using h and grip exercise at 30 % of maximum voluntary contraction significantly reduced SBP and MAP . A lack of reduction in blood pressure in the 5 % group indicates that a low-intensity group may be suitable as a working control for future studies Objectives : Aerobic dynamic exercise reduces blood pressure ( BP ) and is broadly recommended by current American and European hypertension guidelines . Isometric exercise is currently not recommended , since data from only a few studies are available . We compare for the first time the effects of isometric h and grip training and aerobic exercise in a r and omized controlled trial . Methods : A total of 75 hypertensive patients were r and omized to one of the following 12-week programmes : Isometric h and grip training five times weekly ( two contractions of 2 min at 30 % of maximal power with each arm ) ; ‘ Sham-h and grip training ’ five times weekly
Output:
| Conclusions H and grip exercise is an effective modality for resting BP reduction result ing in clinical ly significant reductions for men and women of all ages . |
MS211881 | ***TASK*** the task is to summarize an input biomedical literature 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 conducted a phase II study of S-1 and carboplatin combination regimen in the treatment of patients with advanced non-small cell lung cancer ( NSCLC ) . Chemotherapy-naïve patients with advanced NSCLC were treated with S-1 and carboplatin . S-1 was administered orally twice daily for 14 days and carboplatin AUC 5 on day 1 of each cycle , and this was repeated every 4 weeks . Twenty-nine patients were enrolled in this study . The main grade 3 or 4 toxicities observed during the first cycle were neutropenia ( 10.3 % ) , thrombocytopenia ( 41 % ) , and transaminase elevation . Objective responses were seen in 9 patients ( response rate 31.0 % ) . The median survival time and median progression-free survival were 16.0 months ( 95 % CI , 12.1 - 19.0 months ) and 4.5 months ( 95 % CI , 3.2 - 6.1 months ) , respectively . Hematological adverse events reaching grade 3 or 4 were neutropenia ( 10.3 % ) , anemia ( 3.4 % ) , and thrombocytopenia ( 3.4 % ) . No febrile neutropenia was detected . Nonhematological toxicities were also mild . Although grade 3 infection was observed in 1 patient , the patient improved without intervention . The combination of S-1 plus carboplatin is an active and well-tolerated regimen for the treatment of patients with advanced NSCLC . Further investigations are required to confirm our results in r and omized trials Gefitinib , an epidermal growth factor receptor tyrosine kinase inhibitor ( EGFR-TKI ) , is an effective treatment for advanced non-small cell lung cancer ( NSCLC ) in patients with activating EGFR mutations . However , there have been little evidence -based studies of gefitinib in combination with platinum-doublet therapy in these patients . We performed a phase II trial to determine the efficacy and safety of triplet chemotherapy with gefitinib , carboplatin , and S-1 as a first-line treatment . This was a multicentre , single-arm , phase II trial of carboplatin , S-1 , and gefitinib in advanced NSCLC patients with activating EGFR mutations . Patients received four courses of these drugs in 3–4 week cycles . In each cycle , carboplatin ( area under curve = 5 ) was administered on day 1 , S-1 ( 80 mg/m2 ) on days 1–14 , and gefitinib ( 250 mg ) every day . Subsequently , the same regimen without carboplatin was administered until disease progression or unacceptable toxicity occurred . The 1-year progression-free survival ( PFS ) was the primary endpoint , while response rate ( RR ) , PFS , overall survival ( OS ) , and safety were secondary endpoints . Thirty-five patients were enrolled into this study . The 1-year PFS was 74.3 % and the overall RR was 85.7 % . The median PFS for all patients was 17.6 months ( 95 % confidence interval 15.5–∞ ) , but the median OS was not reached , because 28 patients were still alive after a median follow-up time of 21.4 months . Haematological adverse events ( grade 3 or higher ) included neutropaenia ( 17.1 % ) , thrombocytopenia ( 14.3 % ) , and anaemia ( 5.7 % ) , while non-haematological adverse events ( grade 3 or higher ) included elevated aminotransferase ( 20.0 % ) , diarrhoea ( 14.3 % ) , and febrile neutropaenia ( 2.9 % ) . No interstitial lung disease or treatment-related deaths occurred . Combination chemotherapy with carboplatin , S-1 , and gefitinib is efficacious and well tolerated as a first-line treatment in advanced NSCLC patients with activating EGFR mutations A previous phase 3 trial demonstrated noninferiority in terms of overall survival for combined S‐1 ( an oral fluoropyrimidine ) and carboplatin compared with combined paclitaxel and carboplatin as first‐line treatment for advanced non – small cell lung cancer ( NSCLC ) . In the current study , the authors evaluated the efficacy and safety of combined S‐1 , carboplatin , and bevacizumab followed by maintenance with S‐1 and bevacizumab in chemotherapy‐naive patients with advanced nonsquamous NSCLC The majority of patients with completely resected stage II or IIIA non-small-cell lung cancer ( NSCLC ) require adjuvant chemotherapy to improve survival following surgery . In the present trial , the 2-year disease-free survival ( DFS ) , and the feasibility and safety of S-1 as an adjuvant chemotherapy for advanced lung cancer were evaluated . A total of 40 patients with completely resected stage II or IIIA NSCLC were enrolled and r and omized to receive postoperative chemotherapy with either up to 4 cycles of paclitaxel plus carboplatin ( arm A ) or with up to 1 year of S-1 ( arm B ) . The primary endpoint was 2-year DFS . The secondary endpoints were feasibility and toxicity . A total of 40 patients were enrolled , but 3 were excluded in accordance with the exclusion criteria . The remaining 37 patients were analyzed . The 2-year DFS rate was 54.2 % in arm A and 84.2 % in arm B. Overall , 15/18 ( 83.3 % ) patients completed 4 cycles of paclitaxel plus carboplatin and 13/19 ( 68.4 % ) completed 1-year of S-1adjuvant chemotherapy . Of the 18 ( 16.7 % ) patients in arm A , 3 experienced grade 3 or 4 adverse events , while none in arm B experienced such events . Therefore , S-1 chemotherapy for patients with completely resected stage II or IIIA NSCLC was a feasible and safe regimen , and it may therefore be considered as a potential adjuvant chemotherapy option for advanced NSCLC The objective of this phase I/II study was to determine the recommended dose ( RD ) of S-1 and carboplatin ( CBDCA ) , and to evaluate the efficacy and safety of this combination in the treatment of patients with advanced non-small cell lung cancer ( NSCLC ) . Chemotherapy-naïve patients were treated with S-1 given orally on days 1 - 14 , and CBDCA infused intravenously on day 1 , repeated every 3 weeks . RD was AUC5 of CBDCA and 80 mg/m(2 ) of S-1 . Nineteen patients were treated at the RD . The overall response was 30.8 % ( 95 % confidence interval : 17.1 - 58.3 % ) . The response rate in the RD was 36.8 % ( 95 % CI : 16.3 - 61.6 % ) . The median overall survival time was 11.1 months ( 95 % CI : 8.1 - 15.3 months ) and the median progression-free survival time was 5.0 months ( 95 % CI : 3.6 - 6.0 months ) . Major grade s 3 - 4 toxicities were thrombocytopaenia ( 47 % ) , anaemia ( 26 % ) and infection ( 16 % ) . This is the first report to show promising activity of this combination in phase II , including survival data and manageable toxicity , especially in out patients receiving treatment for advanced NSCLC PURPOSE The primary goal of this open-label , multicenter , r and omized phase III trial was to determine whether treatment with carboplatin plus the oral fluoropyrimidine derivative S-1 was noninferior versus that with carboplatin plus paclitaxel with regard to overall survival ( OS ) in chemotherapy-naive patients with advanced non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS A total of 564 patients were r and omly assigned to receive either carboplatin ( area under the curve , 5 ) on day 1 plus oral S-1 ( 40 mg/m2 twice per day ) on days 1 to 14 or carboplatin ( area under the curve , 6 ) plus paclitaxel ( 200 mg/m2 ) on day 1 every 21 days . RESULTS At the planned interim analysis , with a total of 268 death events available , the study passed the O'Brien-Fleming boundary of 0.0080 for a positive result and noninferiority of carboplatin and S-1 compared with carboplatin and paclitaxel was confirmed for OS ( hazard ratio , 0.928 ; 99.2 % CI , 0.671 to 1.283 ) . Median OS was 15.2 months in the carboplatin and S-1 arm and 13.3 months in the carboplatin and paclitaxel arm , with 1-year survival rates of 57.3 % and 55.5 % , respectively . Rates of leukopenia or neutropenia of grade 3/4 , febrile neutropenia , alopecia , and neuropathy were more frequent in the carboplatin and paclitaxel arm , whereas thrombocytopenia , nausea , vomiting , and diarrhea were more common in the carboplatin and S-1 arm . The carboplatin and S-1 arm had significantly more dose delays than the carboplatin and paclitaxel arm . CONCLUSION Oral S-1 with carboplatin was noninferior in terms of OS compared with carboplatin and paclitaxel in patients with advanced NSCLC , and is thus a valid treatment option Background : The purpose of this study was to evaluate the feasibility and compliance of adjuvant chemotherapy of S-1 plus carboplatin for patients with completely resected non-small cell lung cancer ( NSCLC ) of pathological stage IB-IIIB . Methods : S-1 was given orally at a dose of 80 mg/m2/day for 2 weeks , followed by a 2-week period of no treatment . Carboplatin was given intravenously on day 8 at an area under the curve of 6 . This regimen was repeated for four to six 28-day courses . Results : Seventeen patients were enrolled in this study . Fourteen of them completed at least 4 cycles of chemotherapy . Nine patients had grade 2 and three patients had grade 3 thrombocytopenia , respectively . Severe nonhematologic toxicities were uncommon . Treatment was delayed in a few patients because of prolonged thrombocytopenia . Conclusion : We concluded that the regimen was feasible and tolerable for patients with completely resected NSCLC as adjuvant chemotherapy BACKGROUND A phase III study ( Lung Cancer Evaluation of TS-1 ) previously demonstrated noninferiority in terms of overall survival ( OS ) at interim analysis for carboplatin-S-1 compared with carboplatin-paclitaxel for first-line treatment of advanced non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS A total of 564 patients were r and omly assigned to receive either carboplatin on day 1 plus oral S-1 on days 1 - 14 or carboplatin-paclitaxel on day 1 every 21 days . Up date d results and post hoc subgroup analysis according to tumor histology are presented . RESULTS The up date d analysis revealed a median OS of 15.2 months in the carboplatin-S-1 arm and 13.1 months in the carboplatin-paclitaxel arm , with a hazard ratio ( HR ) of 0.956 [ 95 % confidence interval ( CI ) 0.793 - 1.151 ] , consistent with the previous primary analysis . Median OS was 14.0 months in the carboplatin-S-1 arm and 10.6 months in the carboplatin-paclitaxel arm ( HR 0.713 ; 95 % CI 0.476 - 1.068 ) for patients with squamous cell carcinoma ( SCC ) , with corresponding values of 15.5 and 13.9 months ( HR 1.060 ; 95 % CI 0.859 - 1.308 ) for those with non-SCC . CONCLUSIONS These results establish the efficacy and safety of carboplatin-S-1 in patients with advanced NSCLC regardless of tumor histology Purpose There is no established st and ard regimen for non-small cell lung cancer ( NSCLC ) patients with interstitial lung disease ( ILD ) . For them , we performed a pilot study to evaluate the feasibility of chemotherapy with carboplatin and S-1 , which are known as cytotoxic drug with rare development of ILD as adverse event . Methods A total of 21 chemotherapy-naive NSCLC patients with ILD were prospect ively enrolled between March 2009 and September 2011 . Every 3 weeks , carboplatin at a dose of AUC 5 on day 1 and S-1 at a dose of 80 mg/m2 daily for 14 days were administered . Results The median age at initiating chemotherapy was 67 . Histological examination revealed 10 patients ( 48 % ) with adenocarcinoma . Before chemotherapy , partial pressure of arterial O2 ( PaO2 ) was low with a median of 71 Torr on room air . The median number of cycles administered was four , and the overall response rate and disease control rate were 33 and 67 % , respectively . At the time of data cut-off , all patients were deceased . The median progression-free survival ( PFS ) and median overall survival ( OS ) periods were
Output:
| Conclusion : It will provide latest evidence to determine the efficacy and safety of CS for treatment of patients with NSCLC . |
MS211882 | ***TASK*** the task is to summarize an input biomedical literature 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 : Studies suggest that giving newly born preterm infants sustained lung inflation ( SLI ) may decrease their need for mechanical ventilation ( MV ) and improve their respiratory outcomes . METHODS : We r and omly assigned infants born at 25 weeks 0 days to 28 weeks 6 days of gestation to receive SLI ( 25 cm H2O for 15 seconds ) followed by nasal continuous positive airway pressure ( nCPAP ) or nCPAP alone in the delivery room . SLI and nCPAP were delivered by using a neonatal mask and a T-piece ventilator . The primary end point was the need for MV in the first 72 hours of life . The secondary end points included the need for respiratory supports and survival without bronchopulmonary dysplasia ( BPD ) . RESULTS : A total of 148 infants were enrolled in the SLI group and 143 in the control group . Significantly fewer infants were ventilated in the first 72 hours of life in the SLI group ( 79 of 148 [ 53 % ] ) than in the control group ( 93 of 143 [ 65 % ] ) ; unadjusted odds ratio : 0.62 [ 95 % confidence interval : 0.38–0.99 ] ; P = .04 ) . The need for respiratory support and survival without BPD did not differ between the groups . Pneumothorax occurred in 1 % ( n = 2 ) of infants in the control group compared with 6 % ( n = 9 ) in the SLI group , with an unadjusted odds ratio of 4.57 ( 95 % confidence interval : 0.97–21.50 ; P = .06 ) . CONCLUSIONS : SLI followed by nCPAP in the delivery room decreased the need for MV in the first 72 hours of life in preterm infants at high risk of respiratory distress syndrome compared with nCPAP alone but did not decrease the need for respiratory support and the occurrence of BPD Background Current neonatal resuscitation guidelines recommend 3:1 compression : ventilation ( C : V ) ratio . Recently , animal studies reported that continuous chest compressions ( CC ) during a sustained inflation ( SI ) significantly improved return of spontaneous circulation ( ROSC ) . The approach of CC during SI ( CC+SI ) has not been examined in the delivery room during neonatal resuscitation . Hypothesis It is a feasibility study to compare CC+SI versus 3:1 C : V ratio during neonatal resuscitation in the delivery room . We hypothesised that during neonatal resuscitation , CC+SI will reduce the time to ROSC . Our aim was to examine if CC+SI reduces ROSC compared with 3:1 C : V CPR in preterm infants <33 weeks of gestation . Study design R and omised feasibility trial . Method Once CC was indicated all eligible infants were immediately and r and omly allocated to either CC+SI group or 3:1 C : V group . A sequentially numbered , brown , sealed envelope contained a folded card box with the treatment allocation was opened by the clinical team at the start of CC . Study interventions Infants in the CC+SI group received CC at a rate of 90/min during an SI with a duration of 20 s ( CC+SI ) . After 20 s , the SI was interrupted for 1 s and the next SI was started for another 20 s until ROSC . Infants in the ‘ 3:1 group ’ received CC using 3:1 C : V ratio until ROSC . Primary outcome Overall the mean ( SD ) time to ROSC was significantly shorter in the CC+SI group with 31 ( 9 ) s compared with 138 ( 72 ) s in the 3:1 C : V group ( p=0.011 ) . Conclusion CC+SI is feasible in the delivery room . Trial registration number Clinical trials.gov NCT02083705 , pre- results Abstract Aim : To evaluate efficacy and safety of delivery room ( DR ) sustained lung inflation ( SLI ) in resuscitation of preterm neonates . Methods : R and omized Controlled Trial including 112 preterm infants r and omized to either SLI ( n = 57 ) using T-piece resuscitator [ maximum three inflations with maximum pressure of 30 cmH2O for 15 s followed by continuous positive airway pressure ( CPAP ) of 5–7 cmH2O ] or conventional bag/mask inflation ( C BMI ) ( n = 55 ) using traditional self-inflating bag ( maximum pressure of 40 cmH2O at a rate of 40–60 per min ) . Failure was defined as the need for DR or first 72 h intubation . Cord and 2-h post-resuscitation blood sample s were collected to measure interleukin (IL)-1β and tumor necrosis factor-α levels before and after intervention . Results : SLI was associated with significantly higher success rate compared to C BMI [ 75.4 versus 54.5 % ; p = 0.017 ] , lower need for DR intubation [ 5.3 % versus 23.6 % ; ( X2 = 7.7 ; p = 0.005 ) ] , higher 5-min-Apgar score ( median 8 versus 7 ; p = 0.018 ) , shorter duration on nasal-CPAP ( p = 0.017 ) , and non-significantly different air leak ( 7 % versus 11 % ; p = 0.3 ) and bronchopulmonary dysplasia rates among survivors ( 2 % versus 11 % ; p = 0.09 ) . Post-resuscitation IL-1β plasma levels increased significantly in C BMI ( p = 0.009 ) and not in SLI group . Conclusion : Delivery room SLI is more effective than intermittent bag and mask inflation for improving short-term respiratory outcome in preterm infants , without significant adverse effects AIM To compare the effects of sustained lung inflation ( SLI ) vs. st and ard resuscitation on physiologic responses of preterm infants during resuscitation . METHODS Preterm infants ( 25 - 32 weeks gestational age ) requiring positive-pressure ventilation or continuous positive airway pressure were r and omly assigned to either the SLI group ( SLI at 25cmH2O for 15s ) or Non-SLI group ( st and ard resuscitation alone ) . The heart rate ( HR ) , oxygen saturation ( SpO2 ) , oxygen requirement , and intubation rate in the delivery room were evaluated . RESULTS Eighty-one infants were enrolled ( SLI group , 43 ; Non-SLI group , 38 ) . The use of SLI effectively reduced the oxygen requirement . The mean fraction of inspired oxygen 10min after birth was 0.28 ( 95 % CI , 0.26 - 0.30 ) in the SLI group and 0.47 ( 95 % CI , 0.43 - 0.52 ) in the Non-SLI group ( p<0.001 ) . During the first 5min , infants in the SLI group trended towards a higher HR and SpO2 than those in the Non-SLI group . The intubation rate in the delivery room was not different between the two groups ; however , among infants ≤28 weeks gestational age , the intubation rate was lower in the SLI than Non-SLI group ( 5 of 17 [ 29 % ] vs. 10 of 16 [ 63 % ] , respectively ; p=0.05 ) . The duration of respiratory support , survival without bronchopulmonary dysplasia , and the occurrence of pneumothorax were not different between the groups . CONCLUSION SLI in infants who require respiratory support appears to be effective in facilitating postnatal transition as determined by HR and SpO2 responses , result ing in less oxygen supplementation . Further studies are needed to confirm the benefits of SLI Background : Sustained lung inflation ( SLI ) applied at birth has been demonstrated to lead to clearance of lung fluid and achievement of a precocious functional residual capacity in animal studies . Objectives : To verify if the application of SLI in preterm infants at birth may reduce the need for mechanical ventilation and improve their respiratory outcome . Methods : We prospect ively studied 89 infants with respiratory distress ( gestational age ( GA ) 28.1 ± 2.2 weeks ) treated at birth with a SLI ( 25 cm H2O , sustained for 15 s ) in addition to AAP recommendations versus a historical control group ( n = 119 ; GA 28.1 ± 2.0 weeks ) treated without SLI with the same device ( controlled positive end-expiratory pressure of 5 cm H2O ) . Results : The SLI group had less need for ( 51 vs. 76 % , p < 0.0001 ) and shorter duration of mechanical ventilation ( 5 ± 11 vs. 11 ± 19 days , p = 0.008 ) , a more frequent occurrence of exclusive nasal continuous airway pressure support ( 49 vs. 24 % , p < 0.0001 ) and INtubation-SURfactant-Extubation ( INSURE ) treatment ( 16 vs. 3 % , p = 0.01 ) , less need for surfactant ( 45 vs. 61 % , p = 0.027 ) and postnatal steroids ( 10 vs. 25 % , p = 0.01 ) , a shorter duration of oxygen therapy ( 21 ± 27 vs. 31 ± 31 days , p = 0.016 ) , and , finally , a lower occurrence of bronchopulmonary dysplasia in survivors ( 7 vs. 25 % , p = 0.004 ) . Multiple regression analysis showed that 23–27 weeks of GA and birth weight < 750 g increased the risk of mechanical ventilation , while a clinical risk index for babies ( CRIB ) score <3 as well as INSURE strategy and SLI treatment in the delivery room decreased it . Conclusions : The application of a SLI at birth in preterm infants with respiratory distress may decrease the need for mechanical ventilation without inducing evident adverse effects The protection of preterm lungs should start immediately after birth , and the current trial is a much awaited research in this direction . This study ( 1 ) evaluates the role of application of prophylactic sustained lung inflation ( SLI ) immediately after birth as a lung protective strategy in decreasing the need of mechanical ventilation ( MV ) in first 72 hours of life and in preventing bronchopulmonary dysplasia ( BPD ) among extreme preterm infants . BPD is a multifactorial disease , and the advantage of SLI over intermittent MV in terms of improving functional residual capacity ( 2,3 ) forms the basis of this trial . The application of SLI immediately after birth is a new strategy which was first evaluated by Lindner et al. in 1999 ( 4 ) . Two additional studies showed beneficial effects of SLI ; however , one was an observational study ( 5 ) and the other did not use positive end expiratory pressure ( 6 ) . The current r and omised trial has used nCPAP immediately after birth in the control group and in the intervention group following SLI , thus overcoming the disadvantage of the previous trial . The investigators eluci date d eligibility and exclusion criteria . The actual time of taking consent ( antenatal or immediately after birth ) is not clear . There was appropriate generation of the r and omisation sequence and allocation concealment . Although the research ers who decided to start MV and those assessing the study end points were blinded to the intervention however , the caregivers were not blinded which could have led to performance bias . Given the paucity of the literature , the amount and duration of pressure chosen for providing SLI seem appropriate . Authors have set the SpO2 targets at 88–95 % against the currently recommended targets of 91–95 % . The sample size was calculated a priori , and the outcomes were clearly defined . All r and omised subjects completed the trial as per protocol , and all predefined outcomes were reported . Authors have used intention-totreat principle . This study has shown that the application of prophylactic SLI followed by nCPAP in the delivery room decreased the need for MV in the first 72 hours of life in extreme preterm infants . However , there is no effect on the robust clinical outcomes such as death and /or BPD . Additionally , there is concern of a trend towards increased incidence of pneumothorax and interstitial emphysema , which may be related to the pressure and duration used in SLI . Moreover , there is no statistically significant difference in need and duration of any respiratory support . Although the trial has not result ed in reduction in BPD or death , the reduction in need of MV in first 72 hours may be beneficial in re source -restricted setting s where the availability of MV is limited . Given these findings , the routine application of SLI at birth can not be recommended in extreme preterm infants . More trials are required across different setting s and gestations to establish its efficacy . Given the risk of air leak syndromes , future trials also need to establish the optimal pressure and duration of SLI . Moreover , the data regarding the neurodevelopmental outcome need to be generated to establish its long-term safety Objective : To assess the need for respiratory support in late preterm infants treated with sustained lung inflation ( SLI ) at birth . Study design : In this controlled trial , we r and omly assigned infants born at 34 + 0 to 36 + 6 weeks of gestation to receive SLI ( 25 cmH2O for 15 s ) at birth , followed by continuous positive airway pressure ( CPAP ) or assistance according to the recommendations of the American Academy of Pediatrics . The primary outcome was the need for any type of respiratory support . The secondary outcomes included neonatal intensive care unit ( NICU ) admission for respiratory distress and length of stay . The risk ratios ( RRs ) and 95 % confidence intervals ( CIs ) of the outcomes were calculated for the SLI group in reference to the control
Output:
| Sustained inflation was not better than intermittent ventilation for reducing mortality in the delivery room and during hospitalisation .
When considering secondary outcomes , such as need for intubation , need for or duration of respiratory support , or bronchopulmonary dysplasia , we found no evidence of relevant benefit for sustained inflation over intermittent ventilation .
The duration of mechanical ventilation was shortened in the SLI group . |
MS211883 | ***TASK*** the task is to summarize an input biomedical literature 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 / Aims : Multi-glycoside from Tripterygium wilfordii Hook f. ( GTW ) is used for treatment of progressive glomerulonephritis ( GN ) in China . We have previously reported the beneficial effects of GTW on acute GN induced by an anti-Thy-1.1 monoclonal antibody ( mAb ) . In the present study , the effect and potential mechanisms of GTW on the chronic irreversible model of GN were investigated . Methods : Progressive GN was induced in rats by two intravenous injections of anti-Thy-1.1 mAb 1 - 22 - 3 . Daily oral administration of GTW was started before the second injection of mAb until the day of sacrifice . Ten rats were r and omly divided into a control ( vehicle-treated ) and a GTW-treated group , and sacrificed on day 45 after the first injection of mAb 1 - 22 - 3 . Proteinuria was determined on days 0 , 1 , 3 , 5 , 7 , 10 , 14 , 20 , 25 , 30 , 35 , 40 , and 45 . Blood biochemical parameters , morphological changes of mesangium , glomerular infiltration of macrophage and T lymphocyte , and glomerular mRNA expression of cytokines ( TGF-β , IL-2 , and IFN-γ ) were examined from the sample s taken at terminal sacrifice . Results : GTW treatment significantly ameliorated proteinuria , renal function , prolonged mesangial lesions and inflammatory cell accumulation in glomerulus . In addition , it significantly reduced the glomerular mRNA expression for TGF-β , IL-2 , and IFN-γ . Conclusion : GTW ameliorates prolonged glomerular lesions presumably through suppression of cytokine production ( TGF-β , IL-2 , and IFN-γ ) . GTW could be an effective therapeutic agent for treatment of chronic renal diseases BACKGROUND In a proportion of adults with steroid-resistant nephrotic syndrome ( SRNS ) , intravenous cyclophosphamide therapy fails . Tacrolimus may be a promising alternative to cyclophosphamide for such patients . STUDY DESIGN Prospect i ve observational study . SETTING & PARTICIPANTS 19 adults with SRNS ( 6 with minimal change nephropathy , 8 with focal segmental glomerulosclerosis [ FSGS ] , and 5 with mesangioproliferative glomerulonephritis ) that did not respond to intravenous cyclophosphamide therapy were studied from January 2003 to September 2006 . Oral tacrolimus was administered ( target trough levels , 5 to 10 ng/mL ) for 24 weeks , then reduced doses were given ( target trough level , 3 to 6 ng/mL ) for another 24 weeks . FACTORS Histopathologic types : minimal change nephropathy ( n = 6 ) , FSGS ( n = 8) , and mesangioproliferative glomerulonephritis ( n = 5 ) . OUTCOMES MEASUREMENTS outcome variables included complete remission ( decrease in daily proteinuria to protein < or = 0.3 g/d ) , partial remission ( decrease in daily proteinuria to protein < 3.5 g/d but > 0.3 g/d ) , relapse ( increase in daily proteinuria to protein > or = 3.5 g/d in patients who had partial or complete remission ) , change in kidney function , and tacrolimus dosing and serum levels . RESULTS 17 patients completed at least 24 weeks of tacrolimus therapy . Complete remission was achieved in 11 patients ( 64.7 % ) , and partial remission was achieved in 3 ( 17.6 % ) . Complete or partial remission was achieved in 5 of 5 patients with minimal change nephropathy , 4 of 7 patients with FSGS , and 5 of 5 patients with mesangioproliferative glomerulonephritis . Primary resistance to tacrolimus was seen in 3 patients ( 17.6 % ) , all with FSGS . Mean times to achieve partial and complete remission were 5.6 + /- 1.4 and 8.0 + /- 5.1 weeks , respectively . In patients who achieved complete or partial remission , 35.7 % experienced relapse during follow-up ( mean , 37.6 + /- 13.4 months ) . Two patients had doubling of serum creatinine levels , both with FSGS . LIMITATIONS Observational study . CONCLUSIONS Tacrolimus rapidly and effectively induced remission of SRNS in Chinese adults with disease refractory to treatment with intravenous cyclophosphamide . Treatment may be less effective in patients with FSGS Context In Chinese medicine , extracts of Tripterygium wilfordii Hook F ( TwHF , known as lei gong teng or thunder god vine ) are used to treat autoimmune and inflammatory conditions . Small clinical trials suggest that TwHF may benefit patients with rheumatoid arthritis . Contribution This trial compared TwHF extract with sulfasalazine in 121 patients with active rheumatoid arthritis who could continue oral prednisone and nonsteroidal anti-inflammatory drugs but not disease-modifying antirheumatic drugs . Among patients who continued treatment for 24 weeks , achievement of 20 % improvement in American College of Rheumatology criteria was greater with TwHF than with sulfasalazine . Adverse event rates were similar . Caution Only 62 % and 41 % of patients continued TwHF and sulfasalazine treatment , respectively , and provided 24 weeks of data . The Editors Rheumatoid arthritis is characterized by chronic inflammation of the joint lining ( synovial membrane ) ( 1 ) , which causes pain and swelling of diarthrodial joints . Over time , uncontrolled disease results in progressive joint damage , disability , and increased mortality ( 2 ) . The evolving underst and ing of the immune mechanisms that perpetuate the inflammatory response has led to effective targeted therapies , including inhibitors of inflammatory cytokines ( tumor necrosis factor , interleukin-1 , and interleukin-6 ) , modulators of activation of CD4 + T cells and dendritic cells , and agents that deplete B cells ( 3 , 4 ) . Despite the clinical efficacy of these therapies , many patients have no clinical ly meaningful response or discontinue treatment because of adverse events . Furthermore , the limited availability of effective biologics in developing countries , the need for parenteral administration of the biologics , and the relatively high cost all restrict access to these therapies in many patients with rheumatoid arthritis around the world ( 5 ) . In traditional Chinese medicine , extracts of the roots of the medicinal vine Tripterygium wilfordii Hook F ( TwHF ) ( known in China as lei gong teng or thunder god vine ) have shown therapeutic promise in treating autoimmune and inflammatory conditions as well as cancer ( 68 ) . More recently , different extracts of TwHF have been used in Chinese allopathic medicine for the treatment of autoimmune and inflammatory diseases , and small controlled trials reported good responses with TwHF extracts in patients with cadaveric kidney transplants ( 9 , 10 ) and Crohn disease ( 11 ) . Of the approximately 380 metabolites isolated from the plant , 95 % are terpenoids ( 12 , 13 ) . Three diterpenoidstriptolide , tripdiolide , and triptonide (13)are the most abundant and account for the immunosuppressive and anti-inflammatory effects observed with the root extracts in both in vitro and in vivo studies ( 6 ) . In 2 previous single-center trials of patients with rheumatoid arthritis , the extract was st and ardized by the content of triptolide and tripdiolide ( 14 ) . This made it possible to use optimal doses identified in an open-label trial ( 15 ) for the design of a subsequent small placebo-controlled study ( 16 ) . Although the number of patients was small , the apparent clinical impact and experimental results indicating potent inhibition of the expression of proinflammatory genes both in vitro and in vivo in animal models ( 1721 ) provided the rationale for our multicenter , double-blind , active comparator trial of a st and ardized TwHF extract in patients with active rheumatoid arthritis . Methods Design Overview This r and omized , controlled , 24-week study was conducted between March 2004 and October 2005 . All participants provided written informed consent to enter the trial , and the institutional review boards at the participating sites approved the protocol . All investigators and outcome assessors were blinded to group assignment of the patients . Our objective was to determine whether therapy with TwHF extract , 180 mg/d , was statistically significantly better than therapy with sulfasalazine , 2 g/d , over 24 weeks in patients with rheumatoid arthritis by using st and ard outcome measures . Setting and Participants Our study was conducted at 11 U.S. centers : 2 academic centers ( National Institutes of Health , Bethesda , Maryl and , and University of Texas , Dallas , Texas ) and 9 rheumatology subspecialty clinics ( 1 each in Dallas and Austin , Texas ; Tampa and Fort Lauderdale , Florida ; Arlington , Virginia ; Duncanville , Pennsylvania ; Wheaton and Greenbelt , Maryl and ; and Lansing , Michigan ) . Eligible patients had to be at least 18 years of age and have established rheumatoid arthritis , defined by the American College of Rheumatology ( ACR ) classification criteria ( 22 ) as rheumatoid arthritis lasting longer than 6 months . Eligible patients had active disease , defined as 6 or more painful and swollen joints , a visual analogue scale score for pain of at least 3 ( on a scale of 1 to 10 , with 1 being mild ) , and a C-reactive protein ( CRP ) level of 57.14 nmol/L or greater ( 0.6 mg/dL ) or an erythrocyte sedimentation rate ( ESR ) greater than 25 mm/h . Patients who were taking any disease-modifying antirheumatic drug at screening underwent a 28-day washout period . The use of oral prednisone , at stable doses up to 7.5 mg/d , and nonsteroidal anti-inflammatory drugs were allowed as long as the dose was not changed for 28 days before r and omization and the patient agreed to continue to take the medication during the study . Table 1 lists baseline patient characteristics . Table 1 . Patient Characteristics at Baseline R and omization and Interventions We used a computer-generated , pseudo-r and om code ( with r and om , permuted blocks ) to assign patients to treatment groups across all centers . We assigned eligible patients at a 1:1 ratio to receive either TwHF extract , 180 mg/d , or sulfasalazine , 2 g/d . In the event of gastrointestinal intolerance , the protocol allowed for temporary dose reduction of 50 % . As described elsewhere ( 15 , 16 ) , the triptolide and tripdiolide content of the ethanol and ethylacetate extract ( measured by high-performance liquid chromatography [ 22 ] ) was used to st and ardize the drug preparation for this study . On the basis of data on in vitro activity and in vivo toxicity , 30 mg of TwHF extract were formulated per capsule . Our study was conducted under the U.S Food and Drug Administrationapproved Investigational New Drug application 39191 . Outcomes and Measurements Patients were evaluated clinical ly and by laboratory measures at baseline , 2 weeks , and every 4 weeks for a total of 24 weeks . A rheumatologist or trained staff member masked to treatment allocation assessed the patients . Serum or plasma specimens were obtained from the patients at baseline , 4 weeks , and 24 weeks and stored at 80C until analysis . Radiographs of h and s and feet were obtained at baseline and 24 weeks or at study discontinuation . The primary end point was a 20 % improvement at 24 weeks , as defined by ACR criteria ( ACR 20 ) ( 23 ) . To meet criteria , a patient must have 20 % or greater improvement in both tender and swollen joints ( 68 tender and 66 swollen joints were assessed ) and 20 % or greater improvement in 3 or more of the following : the physician 's or patient 's assessment of global health status , the patient 's assessment of pain on a visual analogue scale , the patient 's assessment of function ( using a modified version of the Health Assessment Question naire [ HAQ ] ) , and the serum CRP level . Secondary end points included the efficacy of TwHF in achieving ACR 50 and ACR 70 responses at 24 weeks , the improvement in the European League Against Rheumatism Disease Activity Score 28 ( DAS 28 ) measure , and a change in the Sharpvan der Heijde score of the h and and foot radiographs ( 24 ) . Radiographs were obtained at baseline and at the end of the study and were scored by 2 independent readers who were blinded to the r and omization schedule and the radiograph sequence . Drug adherence was assessed by using a daily diary and by pill counts . Body weight , blood pressure , and serum glucose level were measured at each visit . Laboratory assessment s included ESR ( Westergren method ) ; high-sensitivity CRP with normal levels up to 38.1 nmol/L ( 0.4 mg/dL ) , which was analyzed in a central laboratory ; and interleukin-6 levels , which were
Output:
| TwHF may have an add-on effect on remission in patients with primary NS .
There was insufficient evidence to assess if TwHF was as effective as prednisone or CPA . |
MS211884 | ***TASK*** the task is to summarize an input biomedical literature 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 aim of this clinical study was to evaluate the association of locally delivered doxycycline ( 10 % ) with scaling and root planing in the periodontal treatment of smokers . METHODS Forty-three patients with chronic periodontitis and a minimum of four pockets ( > or = 5 mm ) on anterior teeth that bled on probing were selected . Patients were r and omly assigned to scaling and root planing ( SRP ) or scaling and root planing followed by local application of doxycycline ( SRP-D ) . Plaque , bleeding on probing , gingival recession , relative attachment level ( RAL ) , and probing depth ( PD ) were recorded at baseline , 45 days , and 3 and 6 months . Differences between baseline and each period were considered for analysis . RESULTS At 6 months , no difference was found between groups regarding plaque , bleeding reduction , gingival recession or PD ( P > 0.05 ) . However , RAL gain was greater for SRP-D ( 1.63 + /- 0.93 mm ) than for SRP ( 1.04 + /- 0.71 mm ) ( P = 0.025 ) . In addition , deep pockets ( > or = 7 mm ) showed a significant reduction ( 3.78 + /- 1.41 versus 2.60 + /- 1.28 mm , P = 0.039 ) and RAL gain ( 2.54 + /- 1.27 mm versus 1.29 + /- 0.95 mm , P = 0.01 ) when doxycycline was applied . The proportion of sites showing RAL gain of 1 to 2 mm was 36.8 % versus 21.7 % for SRP-D and SRP , respectively ( P = 0.01 ) . CONCLUSION The use of locally delivered doxycycline may constitute an important adjunct for the treatment of severe periodontal disease in smokers AIM To evaluate the potential of antimicrobial photodynamic therapy ( aPDT ) as an adjunct to scaling and root planing ( SRP ) in the treatment of chronic periodontitis . MATERIAL AND METHODS In a single-centred r and omized and controlled clinical trial , 90 patients ( 51 females and 39 males ) with untreated chronic periodontitis were r and omly assigned to receive SRP with aPDT ( test group ) or SRP alone ( control group ) . Clinical parameters and halitosis were recorded for 6 months after treatment by a periodontist who was blinded to the procedure . RESULTS Inter-group and intra-group statistical analyses were performed . Significant difference between the two groups with respect to each variable was assessed using non-parametric Rank Order ancova . Probing pocket depth and clinical attachment levels showed statistically significant reduction in the test group on evaluation at 3 months and 6 months as compared to the control group ( p < 0.05 ) . A statistically significant improvement in gingival index and gingival bleeding index was seen for the test group after 2 weeks and 1 month of aPDT ( p < 0.01 ) , whereas the improvement in gingival index and gingival bleeding index at 3 months and in plaque index at 2 weeks after aPDT was less ( p < 0.05 ) . Also , a significant difference was detected for the test group at 1 month in terms of halitosis ( p < 0.05 ) , which did not persist for long . CONCLUSIONS Antimicrobial photodynamic therapy acts as a beneficial adjunct to SRP in non-surgical treatment and management of chronic periodontitis in short-term . Further studies are required to assess the long-term effectiveness of aPDT Objectives This r and omized split-mouth clinical trial was design ed to evaluate the efficacy of scaling and root planing associated to the high-intensity diode laser on periodontal therapy by means of clinical parameters and microbial reduction . Material s and methods A total of 36 chronic periodontitis subjects , of both genders , were selected . One pair of contralateral single-rooted teeth with pocket depth > 5 mm was chosen from each subject . All patients received non-surgical periodontal treatment , after which the experimental teeth were design ated to either test or control groups . Both teeth received scaling , root planing and coronal polishing ( SRP ) and teeth assigned to the test group ( SRP + DL ) were irradiated with the 808 ± 5 nm diode laser , for 20 s , in two isolated appointments , 1 week apart . The laser was used in the continuous mode , with 1.5 W and power density of 1,193.7 W/cm2 . Clinical and microbiological data were collected at baseline , 6 weeks and 6 months after therapy . Results There was a significant improvement of all the clinical parameters— clinical attachment level ( CAL ) , probing depth ( PD ) , plaque index ( PI ) and Bleeding on Probing (BOP)—for both groups ( P < 0.001 ) , with no statistical difference between them at the 6 weeks and the 6 months examinations . As for microbiological analysis , a significant reduction after 6 weeks ( P > 0.05 ) was observed as far as colony forming units ( CFU ) is concerned , for both groups . As for black-pigmented bacteria , a significant reduction was observed in both groups after 6 months . However , the difference between test and control groups was not significant . There was no association between group and presence of Porphyromonas gingivalis , Prevotella intermedia and Aggregatibacter actinomycetemcomitans at any time of the study . Conclusions After 6 months of evaluation , the high-intensity diode laser has not shown any additional benefits to the conventional periodontal treatment . Clinical relevance The high intensity diode laser did not provide additional benefits to non-surgical periodontal treatment . More studies are necessary to prove the actual need of this type of laser in the periodontal clinical practice BACKGROUND / AIM Tobacco use reduces the effect of non-surgical periodontal therapy . Host-modulation with low-dose doxycycline ( LDD ) might favour repair and promote an improved treatment response . The aim of this study was to investigate the effect of LDD in smokers on non-surgical periodontal therapy . MATERIAL AND METHODS This was a parallel arm , r and omized , identical placebo-controlled trial with masking of examiner , care-giver , participant and statistician and 6 months of follow-up . Patients received non-surgical therapy and 3 months of test or control drug . Statistical analysis used both conventional methods and multilevel modelling . RESULTS Eighteen control and 16 test patients completed the study . The velocity of change was statistically greater for the test group for clinical attachment level -0.19 mm/month ( 95 % CI=-0.34 , 0.04 ; p=0.012 ) and probing depth 0.30 mm/month ( 95 % CI=-0.42 , -0.17 ; p<0.001 ) . However , no differences were observed for absolute change in clinical or biochemical markers at 6 months . CONCLUSIONS This study does not provide evidence of a benefit of using LDD as an adjunct to non-surgical periodontal therapy in smokers BACKGROUND Diabetes and periodontitis are complex chronic diseases with an established bidirectional relationship . There is long-established evidence that hyperglycaemia in diabetes is associated with adverse periodontal outcomes . However , given the ubiquity of periodontal diseases and the emerging global diabetes epidemic , the complications of which contribute to significant morbidity and premature mortality , it is timely to review the role of periodontitis in diabetes . AIMS To report the epidemiological evidence from cross-sectional , prospect i ve and intervention studies for the impact of periodontal disease on diabetes incidence , control and complications and to identify potential underpinning mechanisms . EPIDEMIOLOGY Over the last 20 years , consistent and robust evidence has emerged that severe periodontitis adversely affects glycaemic control in diabetes and glycaemia in non-diabetes subjects . In diabetes patients , there is a direct and dose-dependent relationship between periodontitis severity and diabetes complications . Emerging evidence supports an increased risk for diabetes onset in patients with severe periodontitis . BIOLOGICAL MECHANISMS Type 2 diabetes is preceded by systemic inflammation , leading to reduced pancreatic β-cell function , apoptosis and insulin resistance . Increasing evidence supports elevated systemic inflammation ( acute-phase and oxidative stress biomarkers ) result ing from the entry of periodontal organisms and their virulence factors into the circulation , providing biological plausibility for the effects of periodontitis on diabetes . AGE ( Advanced Glycation Endproducts)-RAGE ( Receptor for AGEs ) interactions and oxidative-stress-mediated pathways provide plausible mechanistic links in the diabetes to periodontitis direction . INTERVENTIONS R and omized controlled trials ( RCTs ) consistently demonstrate that mechanical periodontal therapy associates with approximately a 0.4 % reduction in HbA1C at 3 months , a clinical impact equivalent to adding a second drug to a pharmacological regime for diabetes . RCTs are needed with larger numbers of subjects and longer term follow-up , and if results are substantiated , adjunctive periodontal therapies subsequently need to be evaluated . There is no current evidence to support adjunctive use of antimicrobials for periodontal management of diabetes patients . GUIDELINES Given the current evidence , it is timely to provide guidelines for periodontal care in diabetes patients for medical and dental professionals and recommendations for patients /the public The aim of this r and omized , parallel , controlled clinical trial was to examine the clinical and biochemical efficacy of diode laser as an adjunct to scaling and root planing ( SRP ) . Thirty chronic periodontitis patients were r and omly assigned into two groups to receive SRP alone ( control ) or SRP followed by diode laser ( test ) . Plaque index , gingival index , bleeding on probing , probing depth , and clinical attachment level were measured at baseline and at 1 , 3 , and 6 months after treatment . The gingival crevicular fluid levels of interleukin-1β ( IL-1β ) , interleukin-6 ( IL-6 ) , interleukin-8 ( IL-8 ) , matrix metalloproteinase-1 ( MMP-1 ) , matrix metalloproteinase-8 ( MMP-8 ) and tissue inhibitor matrix metalloproteinase-1 ( TIMP-1 ) were analyzed by enzyme-linked immunosorbent assay . Test group showed significantly a better outcome compared to the control group in full-mouth clinical parameters . MMP-1 , MMP-8 , and TIMP-1 showed significant differences between groups after treatment compared to baseline ( p < 0.05 ) . The total amount of IL-1β , IL-6 , MMP-1 , MMP-8 , and TIMP-1 decreased ( p < 0.05 ) and IL-8 increased after treatment in both test and control groups ( p < 0.05 ) . Diode laser provided significant improvements in clinical parameters and MMP-8 was significantly impacted by the adjunctive laser treatment at first month providing an insight to how lasers can enhance the outcomes of the nonsurgical periodontal therapy The primary goal of periodontal therapy is the removal of supra and subgingival bacterial deposits by mechanical debridement consisting in scaling and root-planing ( SRP ) using manual or power-driven instruments . The complete removal of bacteria and their toxins from periodontal pockets is not always achieved with conventional mechanical treatment . The use of lasers as an adjunctive therapy for periodontal disease may improve tissue healing by bactericidal and detoxification effects . The aim of this study was to compare the effectiveness of Diode laser used as adjunctive therapy of SRP to that of SRP alone for non surgical periodontal treatment in patients with chronic periodontitis . Nineteen pairs of teeth with untreated chronic periodontitis were selected in 13 patients and r and omly treated by SRP alone ( control group ) or by SRP + laser irradiation ( test group ) . Clinical measurements ( PPD , CAL , BOP , GI , PI ) were performed before treatment at baseline ( T0 ) and at T1 ( after 4 weeks ) , T2 ( 8 weeks ) , T3 ( 12 weeks ) , T4 ( 6 months ) . Subgingival plaque sample s were taken at baseline and after treatment and examined for 8 periopathogens bacteria using PCR technique . The present study showed that the additional treatment with diode laser may lead to a slightly improvement of clinical parameters , whereas no significant differences between test and control group in reduction of periodontopathogens were found OBJECTIVE The aim of this clinical trial was to determine the clinical and biochemical efficacy of an 810 nm diode laser as an adjunct to scaling and root planing ( SRP ) . BACKGROUND DATA Lasers can achieve excellent tissue ablation with strong bactericidal and detoxification effects . The use of lasers is one of the most promising new technical modalities for nonsurgical periodontal treatment . However , the most effective wavelength and parameters for their use are still under investigation . METHODS This study was design ed as a single-blinded , r and omized-controlled , split-mouth clinical trial . Twenty-one patients ( 12 females and 9 males between 26 and 55 years of age ) , diagnosed with generalized chronic periodontitis , were included in the study . After initial periodontal therapy , which consisted of oral hygiene instructions and scaling , patients underwent two different treatment modalities . Test and control sites were chosen with coin toss r and omization . At the test site , patients received SRP and laser treatment ; at the contralateral control site , they received SRP treatment alone . RESULTS Both treatment modalities result ed in significant improvements in all clinical and biochemical parameters . Sites irrad
Output:
| The panel judged the following 4 adjunctive therapies as beneficial with a moderate level of certainty : systemic subantimicrobial-dose doxycycline , systemic antimicrobials , chlorhexidine chips , and photodynamic therapy with a diode laser .
There was a low level of certainty in the benefits of the other included adjunctive therapies . |
MS211885 | ***TASK*** the task is to summarize an input biomedical literature 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 document the prevalence and patterns of use of alternative medical therapies as well as their perceived effectiveness by patients in a rehabilitation medicine outpatient practice . DESIGN Cross-sectional survey by written question naire . SETTING An urban rehabilitation medicine outpatient referral office . PATIENTS A r and om sample of 103 patients referred for rehabilitation outpatient care , while waiting for their appointment , were given a question naire addressing their use of alternative therapies . MAIN OUTCOME MEASURES Use of alternative therapies and their perceived effectiveness . RESULTS One or more alternative medical therapies had been used by 29.1 % of subjects in the past 12 months for their presenting problem . The most common therapies were massage , chiropractic , vitamin and mineral supplementation , and acupuncture . Musculoskeletal pain syndromes involving the spine and extremities were the most common problems for which patients sought both physiatric and alternative care . Of the patients who used alternative treatments 53 % reported some degree of efficacy . CONCLUSIONS A significant proportion of rehabilitation medicine patients use and frequently perceive a benefit from alternative therapies , particularly massage , chiropractic , vitamin and mineral supplementation , and acupuncture . Incorporating alternative therapies into physiatric practice is a desirable future direction for the specialty Three treatments for non-specific lumbar pain -- balneotherapy , underwater traction bath , and underwater massage -- were assessed in a r and omised prospect i ve controlled trial in 158 out patients . Each group was treated for four weeks and patients were review ed at the end of this period and at 12 months after entry to the trial . The prescription of analgesics and the pain score were significantly reduced in all three treated groups , but there was no difference between the three groups . No significant change occurred in spinal motion and the straight leg raising test . After one year only the analgesic consumption was significantly lower than in the control group OBJECTIVE --To compare the effectiveness of manipulative therapy , physiotherapy , treatment by the general practitioner , and placebo therapy in patients with persistent non-specific back and neck complaints . DESIGN --R and omised clinical trial . SETTING -- Primary health care in the Netherl and s. PATIENTS --256 patients with non-specific back and neck complaints of at least six weeks ' duration who had not received physiotherapy or manipulative therapy in the past two years . INTERVENTIONS --At the discretion of the manipulative therapists , physiotherapists , and general practitioners . Physiotherapy consisted of exercises , massage , and physical therapy ( heat , electrotherapy , ultrasound , shortwave diathermy ) . Manipulative therapy consisted of manipulation and mobilisation of the spine . Treatment by general practitioners consisted of drugs ( for example , analgesics ) , advice about posture , home exercises , and (bed)rest . Placebo treatment consisted of detuned shortwave diathermy ( 10 minutes ) and detuned ultrasound ( 10 minutes ) . MAIN OUTCOME MEASURES --Changes in severity of the main complaint and limitation of physical functioning measured on 10 point scales by a blinded research assistant and global perceived effect measured on a 6 point scale by the patients . RESULTS --Many patients in the general practitioner and placebo groups received other treatment during follow up . Improvement in the main complaint was larger with manipulative therapy ( 4.5 ) than with physiotherapy ( 3.8 ) after 12 months ' follow up ( difference 0.9 ; 95 % confidence interval 0.1 to 1.7 ) . Manipulative therapy also gave larger improvements in physical functioning ( difference 0.6 ; -0.1 to 1.3 ) . The global perceived effect after six and 12 months ' follow up was similar for both treatments . CONCLUSIONS --Manipulative therapy and physiotherapy are better than general practitioner and placebo treatment . Furthermore , manipulative therapy is slightly better than physiotherapy after 12 months BACKGROUND The effectiveness of massage therapy for low-back pain has not been documented . This r and omized controlled trial compared comprehensive massage therapy ( soft-tissue manipulation , remedial exercise and posture education ) , 2 components of massage therapy and placebo in the treatment of subacute ( between 1 week and 8 months ) low-back pain . METHODS Subjects with subacute low-back pain were r and omly assigned to 1 of 4 groups : comprehensive massage therapy ( n = 25 ) , soft-tissue manipulation only ( n = 25 ) , remedial exercise with posture education only ( n = 22 ) or a placebo of sham laser therapy ( n = 26 ) . Each subject received 6 treatments within approximately 1 month . Outcome measures obtained at baseline , after treatment and at 1-month follow-up consisted of the Rol and Disability Question naire ( RDQ ) , the McGill Pain Question naire ( PPI and PRI ) , the State Anxiety Index and the Modified Schober test ( lumbar range of motion ) . RESULTS Of the 107 subjects who passed screening , 98 ( 92 % ) completed post-treatment tests and 91 ( 85 % ) completed follow-up tests . Statistically significant differences were noted after treatment and at follow-up . The comprehensive massage therapy group had improved function ( mean RDQ score 1.54 v. 2.86 - 6.5 , p < 0.001 ) , less intense pain ( mean PPI score 0.42 v. 1.18 - 1.75 , p < 0.001 ) and a decrease in the quality of pain ( mean PRI score 2.29 v. 4.55 - 7.71 , p = 0.006 ) compared with the other 3 groups . Clinical significance was evident for the comprehensive massage therapy group and the soft-tissue manipulation group on the measure of function . At 1-month follow-up 63 % of subjects in the comprehensive massage therapy group reported no pain as compared with 27 % of the soft-tissue manipulation group , 14 % of the remedial exercise group and 0 % of the sham laser therapy group . INTERPRETATION Patients with subacute low-back pain were shown to benefit from massage therapy , as regulated by the College of Massage Therapists of Ontario and delivered by experienced massage therapists Delayed onset muscle soreness is a common problem that can interfere with rehabilitation as well as activities of daily living . The purpose of this study was to test the impact of therapeutic massage , upper body ergometry , or microcurrent electrical stimulation on muscle soreness and force deficits evident following a high-intensity eccentric exercise bout . Forty untrained , volunteer female subjects were r and omly assigned to one of three treatment groups or to a control group . Exercise consisted of high-intensity eccentric contractions of the elbow flexors . Resistance was reduced as subjects fatigued , until they reached exhaustion . Soreness rating was determined using a visual analog scale . Force deficits were determined by measures of maximal voluntary isometric contraction at 90 degrees of elbow flexion and peak torque for elbow flexion at 60 degrees/sec on a Cybex II isokinetic dynamometer . Maximal voluntary isometric contraction and peak torque were determined at the 0 hour ( before exercise ) and again at 24 and 48 hours postexercise . Treatments were applied immediately following exercise and again at 24 hours after exercise . The control group subjects rested following their exercise bout . Statistical analysis showed significant increases in soreness rating and significant decreases in force generated when the 0 hour was compared with 24- and 48-hour measures . Further analysis indicated no statistically significant differences between massage , microcurrent electrical stimulation , upper body ergometry , and control groups We conducted a pilot study to evaluate a practical exercise program for elderly people with chronic musculo-skeletal pain . Thirty-three subjects ( mean age , 73 years ; 69 % back pain ; 24 % knee pain ; 9 % hip pain ) were r and omly assigned to one of three groups . Group 1 received a 6-week supervised program of walking . Group 2 received a pain education program that included instruction and demonstration of use of heat , cold , massage , relaxation and distraction . Group 3 received usual care . Outcomes including pain , self-reported health and functional status , and performance-based measures of functional status were evaluated at baseline , at two weeks and at eight weeks ( end of study ) . Attendance was 100 % for the education sessions and 93 % for walking sessions . No injuries were sustained . Both intervention groups demonstrated significant improvements in pain ( p<0.05 ) and performance-based measures of functional status ( p<0.05 ) , while the control group had no changes . These data suggest that patient education and fitness walking can improve overall pain management and related functional limitations among elderly people with chronic musculo-skeletal pain Evaluating the effectiveness of nursing interventions in decreasing pain is a top priority for clinical research . Unfortunately , most of the research on cancer pain relief has been limited to treatment studies involving the administration of analgesics . Research is needed to determine which nonanalgesic methods of pain control are effective and under what conditions . Consequently , an experimental study was design ed to test the effectiveness of massage as an intervention for cancer pain . Twenty-eight patients were r and omly assigned to a massage or control group . The patients in the massage group were given a 10 minute massage to the back ; the patients in the control group were visited for 10 minutes . For males , there was a significant decrease in pain level immediately after the massage . For females , there was not a significant decrease in pain level immediately after the massage . There were no significant differences between pain 1 hour and 2 hours after the massage in comparison with the initial pain for males or females . Massage was shown to be an effective short-term nursing intervention for pain in males in this sample & NA ; It has recently been shown that ice massage of the web between the thumb and index finger produces significantly greater relief of dental pain than a placebo control procedure . These results indicate that ice massage may be comparable to transcutaneous electrical stimulation ( TES ) and acupuncture , and may be mediated by similar neural mechanisms . The purpose of this study was to examine the relative effectiveness of ice massage and TES for the relief of low‐back pain . Patients suffering chronic low‐back pain were treated with both ice massage and TES . The order of treatments was balanced , and changes in the intensity of pain were measured with the McGill Pain Question naire ( MPQ ) . The results show that both methods are equally effective : based on the Pain Rating Index of the MPQ , 67–69 % of patients obtained pain relief greater than 33 % with each method . The results indicate that ice massage is an effective therapeutic tool , and appears to be more effective than TES for some patients . It may also serve as an additional sensory‐modulation method to alternate with TES to overcome adaptation effects . Evidence that cold signals are transmitted to the spinal cord exclusively by A‐delta fibers and not by C fibers suggests that ice massage provides a potential method for differentiating among the multiple feedback systems that mediate analgesia produced by different forms of intense sensory input One year after head trauma , 23 patients with post-traumatic headache entered a prospect i ve clinical controlled trial to find out if specific manual therapy on the neck could reduce the headache . The study was completed by 19 patients ( 83 % ) . Ten patients were treated twice with manual therapy and nine patients were treated twice with cold packs on the neck . The pain index was calculated blindly . Two weeks after the last treatment the mean pain index was significantly reduced to 43 % in the group treated with manual therapy compared with the pretreatment level . At follow-up five weeks later , the pain index was still lower in this group compared with the group treated with cold packs , but this difference was not statistically significant . The pain index for all 19 patients was significantly correlated to the use of analgesics as well as to the frequency of associated symptoms ( number of days per week with dizziness , visual disturbances and ear symptoms ) . It is concluded that the type of manual therapy used in this study seems to have a specific effect in reducing post-traumatic headache . The result supports the hypothesis of a cervical mechanism causing post-traumatic headache and suggests that post-traumatic dizziness , visual disturbances and ear symptoms could be part of a cervical syndrome Patients with acute or chronic low back pain were treated in a double-blind study that compared transcutaneous electrical nerve stimulation at intense levels and gentle , mechanically administered massage . Transcutaneous electrical nerve stimulation produced significantly greater pain relief , based on two measures of the McGill Pain Question naire , and significant improvement in straight leg raising . There were no significant differences between the two groups in backflexion scores . Pain-relief scores and range-of-motion scores were significantly correlated . The results indicate that pain-relief scores provide valuable information and can easily be obtained from patients for whom pain is a major symptom BACKGROUND Because the value of popular forms of alternative care for chronic back pain remains uncertain , we compared the effectiveness of acupuncture , therapeutic massage , and self-care education for persistent back pain . METHODS We r and omized 262 patients aged 20 to 70 years who had persistent back pain to receive Traditional Chinese Medical acupuncture ( n = 94 ) , therapeutic massage ( n = 78 ) , or self-care educational material s ( n = 90 ) . Up to 10 massage or acupuncture visits were permitted over 10 weeks . Symptoms ( 0 - 10 scale ) and dysfunction ( 0 - 23 scale ) were assessed by telephone interviewers masked to treatment group . Follow-up was available for 95 % of patients after 4 , 10 , and 52 weeks , and none withdrew for adverse effects . RESULTS Treatment groups were compared after adjustment for prer and omization covariates using an intent-to-treat analysis . At 10 weeks , massage was superior to self-care on the symptom scale ( 3.41 vs 4.
Output:
| They showed that massage was inferior to manipulation and transcutaneous electrical nerve stimulation ; massage was equal to corsets and exercises ; and massage was superior to relaxation therapy , acupuncture , and self-care education .
CONCLUSIONS Massage might be beneficial for patients with subacute and chronic nonspecific LBP , especially when combined with exercises and education .
The evidence suggests that acupuncture massage is more effective than classic massage , but this needs confirmation . |
MS211886 | ***TASK*** the task is to summarize an input biomedical literature 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: Between August 1990 and August 1995 , 231 patients ( median age 51 , 53 % Durie-Salmon stage III , median serum beta-2-microglobulin 3.1 g/L , median C-reactive protein 4 g/L ) with symptomatic multiple myeloma were enrolled in a program that used a series of induction regimens and two cycles of high-dose therapy ( " Total Therapy " ) . Remission induction utilized non-cross-resistant regimens ( vincristine-doxorubicin-dexamethasone [ VAD ] , high-dose cyclophosphamide and granulocyte-macrophage colony-stimulating factor with peripheral blood stem cell collection , and etoposide-dexamethasone-cytarabine-cisplatin ) . The first high-dose treatment comprised melphalan 200 mg/m2 and was repeated if complete ( CR ) or partial ( PR ) remission was maintained after the first transplant ; in case of less than PR , total body irradiation or cyclophosphamide was added . Interferon--2b maintenance was used after the second autotransplant . Fourteen patients with HLA-compatible donors underwent an allograft as their second high-dose therapy cycle . Eighty-eight percent completed induction therapy whereas first and second transplants were performed in 84 % and 71 % ( the majority within 8 and 15 months , respectively ) . Eight patients ( 3 % ) died of toxicity during induction , and 2 ( 1 % ) and 6 ( 4 % ) during the two transplants . True CR and at least a PR ( PR plus CR ) were obtained in 5 % ( 34 % ) after VAD , 15 % ( 65 % ) at the end of induction , and 26 % ( 75 % ) after the first and 41 % ( 83 % ) after the second transplants ( intent-to-treat ) . Median overall ( OS ) and event-free ( EFS ) survival duration s were 68 and 43 months , respectively . Actuarial 5-year OS and EFS rates were 58 % and 42 % , respectively . The median time to disease progression or relapse was 52 months . Among the 94 patients achieving CR , the median CR duration was 50 months . On multivariate analysis , superior EFS and OS were observed in the absence of unfavorable karyotypes ( 11q breakpoint abnormalities , -13 or 13-q ) and with low beta-2-microglobulin at diagnosis . CR duration was significantly longer with early onset of CR and favorable karyotypes . Time-dependent covariate analysis suggested that timely application of a second transplant extended both EFS and OS significantly , independent of cytogenetics and beta-2-microglobulin . Total Therapy represents a comprehensive treatment approach for newly diagnosed myeloma patients , using multi-regimen induction and t and em transplantation followed by interferon maintenance . As a result , the proportion of patients attaining CR increased progressively with continuing therapy . This observation is particularly important because CR is a sine qua non for long-term disease control and , eventually , cure Thalidomide ( Thal ) can overcome drug resistance in multiple myeloma ( MM ) but is associated with somnolence , constipation , and neuropathy . In previous in vitro studies , we have shown that the potent immunomodulatory derivative of thalidomide ( IMiD ) CC-5013 induces apoptosis or growth arrest even in resistant MM cell lines and patient cells , decreases binding of MM cells to bone marrow stromal cells ( BMSCs ) , inhibits the production in the BM milieu of cytokines ( interleukin-6 [ IL-6 ] , vascular endothelial growth factor [ VEGF ] , tumor necrosis factor-alpha [ TNF-alpha ] ) mediating growth and survival of MM cells , blocks angiogenesis , and stimulates host anti-MM natural killer ( NK ) cell immunity . Moreover , CC-5013 also inhibits tumor growth , decreases angiogenesis , and prolongs host survival in a human plasmacytoma mouse model . In the present study , we carried out a phase 1 CC-5013 dose-escalation ( 5 mg/d , 10 mg/d , 25 mg/d , and 50 mg/d ) study in 27 patients ( median age 57 years ; range , 40 - 71 years ) with relapsed and refractory relapsed MM . They received a median of 3 prior regimens ( range , 2 - 6 regimens ) , including autologous stem cell transplantation and Thal in 15 and 16 patients , respectively . In 24 evaluable patients , no dose-limiting toxicity ( DLT ) was observed in patients treated at any dose level within the first 28 days ; however , grade 3 myelosuppression developed after day 28 in all 13 patients treated with 50 mg/d CC-5013 . In 12 patients , dose reduction to 25 mg/d was well tolerated and therefore considered the maximal tolerated dose ( MTD ) . Importantly , no significant somnolence , constipation , or neuropathy has been seen in any cohort . Best responses of at least 25 % reduction in paraprotein occurred in 17 ( 71 % ) of 24 patients ( 90 % confidence interval [ CI ] , 52%-85 % ) , including 11 ( 46 % ) patients who had received prior Thal . Stable disease ( less than 25 % reduction in paraprotein ) was observed in an additional 2 ( 8 % ) patients . Therefore , 17 ( 71 % ) of 24 patients ( 90 % CI , 52%-85 % ) demonstrated benefit from treatment . Our study therefore provides the basis for the evaluation of CC-5013 , either alone or in combination , to treat patients with MM at earlier stages of disease BACKGROUND In this trial of the treatment of newly diagnosed multiple myeloma , we compared a protocol that entailed a hematopoietic stem-cell autograft followed by an allograft from an HLA-identical sibling with a protocol of t and em autografts . METHODS We enrolled 162 consecutive patients with newly diagnosed myeloma who were 65 years of age or younger and who had at least one sibling . All patients were initially treated with vincristine , doxorubicin , and dexamethasone , followed by melphalan and autologous stem-cell rescue . Patients with an HLA-identical sibling then received nonmyeloablative total-body irradiation and stem cells from the sibling . Patients without an HLA-identical sibling received two consecutive myeloablative doses of melphalan , each of which was followed by autologous stem-cell rescue . The primary end points were overall survival and event-free survival . RESULTS After a median follow-up of 45 months ( range , 21 to 90 ) , the median overall survival and event-free survival were longer in the 80 patients with HLA-identical siblings than in the 82 patients without HLA-identical siblings ( 80 months vs. 54 months , P=0.01 ; and 35 months vs. 29 months , P=0.02 , respectively ) . Among patients who completed their assigned treatment protocol s , treatment-related mortality did not differ significantly between the double-autologous-transplant group ( 46 patients ) and the autograft-allograft group ( 58 patients , P=0.09 ) , but disease-related mortality was significantly higher in the double-autologous-transplant group ( 43 % vs. 7 % , P<0.001 ) . The cumulative incidence rates of grade s II , III , and IV graft-versus-host disease ( GVHD ) combined and of grade IV GVHD in the autograft-allograft group were 43 % and 4 % , respectively . Overall , 21 of 58 patients ( 36 % ) were in complete remission after a median follow-up of 38 months ( range , 10 to 72 ) after allografting . Of the 46 patients who received two autografts , 25 ( 54 % ) died . CONCLUSIONS Among patients with newly diagnosed myeloma , survival in recipients of a hematopoietic stem-cell autograft followed by a stem-cell allograft from an HLA-identical sibling is superior to that in recipients of t and em stem-cell autografts . ( Clinical Trials.gov number , NCT00415987 [ Clinical Trials.gov ] . ) BACKGROUND AND OBJECTIVES The Dutch-Belgian HOVON group performed a r and omized phase 3 trial to compare single non-myeloablative intensive treatment with double , intensive treatment in previously untreated patients with multiple myeloma ( MM ) . DESIGN AND METHODS Three hundred and three patients with stage II/III MM were r and omized after VAD induction chemotherapy to receive two cycles of non-myeloablative intermediate-dose melphalan ( 70 mg/m2 ) ( single treatment ) or the same regimen followed by cyclophosphamide 120 mg/kg iv plus total body irradiation ( TBI ) 9 Gy and autologous stem cell transplantation ( double , intensive treatment ) . In both treatment arms interferon .IIa was given as maintenance until relapse/progression . RESULTS A significantly higher proportion of patients achieved a complete remission ( CR ) on protocol treatment with double , intensive therapy ( 32 % vs 13 % , p<0.001 ) . Double treatment produced better outcome in terms of event-free survival ( median 22 vs 21 months , 28 % vs 14 % at 4 years and 15 % vs 7 % at 6 years after r and omization ; logrank p=0.013 ; univariate HR 0.74 , 95 % CI , 0.58 - 0.94 ) , progression-free survival ( median 27 vs 24 months , 33 % vs 16 % at 4 years , and 17 % vs 9 % at 6 years after r and omization ; logrank p=0.006 ; HR=0.71 , 95 % CI 0.56 - 0.91 ) , but not overall survival ( median 50 vs 55 months , 52 % vs 56 % at 4 years and 39 % vs 36 % at 6 years after r and omization ; logrank p=0.51 ; HR=1.10 , 95 % CI 0.83 - 1.46 ) . The achievement of a CR had a favorable prognostic impact on event-free survival ( HR=0.60 , 95 % CI=0.44 -0.82 , p=0.001 ) and progression-free survival ( HR=0.62 , 95 % CI=0.45 -0.84 , p=0.002 ) . INTERPRETATION AND CONCLUSIONS Double , intensive treatment result ed in a better CR rate , event-free survival and progression-free survival but not overall survival compared to single non-myeloablative treatment in previously untreated patients with multiple myeloma BACKGROUND Autologous haemopoietic stem-cell transplantation ( HSCT ) improves survival in patients with multiple myeloma , but disease progression remains an issue . Allogeneic HSCT might reduce disease progression , but can be associated with high treatment-related mortality . Thus , we aim ed to assess effectiveness of allogeneic HSCT with non-myeloablative conditioning after autologous HSCT compared with t and em autologous HSCT . METHODS In our phase 3 biological assignment trial , we enrolled patients with multiple myeloma attending 37 transplant centres in the USA . Patients ( < 70 years old ) with adequate organ function who had completed at least three cycles of systemic antimyeloma therapy within the past 10 months were eligible for inclusion . We assigned patients to receive an autologous HSCT followed by an allogeneic HSCT ( auto-allo group ) or t and em autologous HSCTs ( auto-auto group ) on the basis of the availability of an HLA-matched sibling donor . Patients in the auto-auto group subsequently underwent a r and om allocation ( 1:1 ) to maintenance therapy ( thalidomide plus dexamethasone ) or observation . To avoid enrolment bias , we classified patients as st and ard risk or high risk on the basis of cytogenetics and β2-microglobulin concentrations . We used the Kaplan-Meier method to estimate differences in 3-year progression-free survival ( PFS ; primary endpoint ) between patients with st and ard-risk disease in the auto-allo group and the best results from the auto-auto group ( maintenance , observation , or pooled ) . This study is registered with Clinical Trials.gov , number NCT00075829 . FINDINGS Between Dec 17 , 2003 , and March 30 , 2007 , we enrolled 710 patients , of whom 625 had st and ard-risk disease and received an autologous HSCT . 156 ( 83 % ) of 189 patients with st and ard-risk disease in the auto-allo group and 366 ( 84 % ) of 436 in the auto-auto group received a second transplant . 219 patients in the auto-auto group were r and omly assigned to observation and 217 to receive maintenance treatment , of whom 168 ( 77 % ) completed this treatment . PFS and overall survival did not differ between maintenance and observation groups and pooled data were used . Kaplan-Meier estimates of 3-year PFS were 43 % ( 95 % CI 36 - 51 ) in the auto-allo group
Output:
| Conclusion Despite higher complete remission rates , there is no improvement in OS with auto-allo HCT ; but this approach results in higher NRM in patients with newly diagnosed MM . |
MS211887 | ***TASK*** the task is to summarize an input biomedical literature 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 Farmers have an increased risk of respiratory morbidity and mortality . The causal agents have not been fully established . METHODS In a cross-sectional study of 4,735 Norwegian farmers , we assessed respiratory symptoms and lung function . Atopy was assessed in a sub sample ( n = 1,213 ) . Personal exposures to dust , fungal spores , actinomycete spores , endotoxins , bacteria , storage mites , (1 - ->3)-ss-D-glucans , fungal antigens , organic dust , inorganic dust , silica , ammonia , and hydrogen sulfide were measured for 127 r and omly selected farms . RESULTS Compared to crop farmers , livestock farmers were more likely to have chronic bronchitis ( odds ratio [ OR ] , 1.9 ; 95 % confidence interval [ CI ] , 1.4 to 2.6 ) and COPD ( OR , 1.4 ; 95 % CI , 1.1 to 1.7 ) . FEV(1 ) ( -41 mL ; 95 % CI , -75 to -7 ) was significantly reduced , but FVC ( -15 mL ; 95 % CI , -54 to 24 ) was not . Exposure to most agents were predictors of respiratory morbidity , except FVC . Ammonia , hydrogen sulfide , and inorganic dust were most strongly associated in multiple regression models adjusted for coexposures , but the effects of specific biological agents could not be assessed in multiple regression models because they were too highly correlated . Farmers with atopy had a significantly lower FEV(1 ) ( OR , -87 mL ; 95 % CI , -170 to -7 ) , but atopy was not directly associated with chronic bronchitis , COPD , and FVC . However , the effects of farming and specific exposures on COPD were substantially greater in farmers with atopy . CONCLUSIONS Livestock farmers have an increased risk of chronic bronchitis , COPD , and reduced FEV(1 ) . Ammonia , hydrogen sulfide , inorganic dust , and organic dust may be causally involved , but a role for specific biological agents can not be excluded . Farmers with atopy appear more susceptible to develop farming-related COPD In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias OBJECTIVES . Little is known about the health effects of living in close proximity to industrial swine operations . We assessed the relationship between estimated exposure to airborne effluent from confined swine feeding operations and asthma symptoms among adolescents who were aged 12 to 14 years . METHODS . During the 1999–2000 school year , 58169 adolescents in North Carolina answered questions about their respiratory symptoms , allergies , medications , socioeconomic status , and household environments . To estimate the extent to which these students may have been exposed during the school day to air pollution from confined swine feeding operations , we used publicly available data about schools ( n = 265 ) and swine operations ( n = 2343 ) to generate estimates of exposure for each public school . Prevalence ratios and 95 % confidence intervals for wheezing within the past year were estimated using r and om-intercepts binary regression models , adjusting for potential confounders , including age , race , socioeconomic status , smoking , school exposures , and household exposures . RESULTS . The prevalence of wheezing during the past year was slightly higher at schools that were estimated to be exposed to airborne effluent from confined swine feeding operations . For students who reported allergies , the prevalence of wheezing within the past year was 5 % higher at schools that were located within 3 miles of an operation relative to those beyond 3 miles and 24 % higher at schools in which livestock odor was noticeable indoors twice per month or more relative to those with no odor . CONCLUSIONS . Estimated exposure to airborne pollution from confined swine feeding operations is associated with adolescents ’ wheezing symptoms OBJECTIVES To describe the relation between spirometric findings and farming characteristics and variables of exposure to organic dust measured during work in animal buildings . Farmers have traditionally been described as having one of the most dangerous occupations , so a large scale study on European farmers was carried out . This is the report of the second part of that study . METHODS 40 pig farmers in Denmark and 36 poultry farmers in Switzerl and were chosen r and omly and were assessed over 1 working day . RESULTS Mean ( SD ) baseline spirometric results in pig farmers were higher than in poultry farmers ( forced expiratory volume in 1 second ( FEV1 ) ( % of reference value ) 108.3 ( 16.7 ) v 100.2 ( 14.2 ) ; p=0.04 ) . Baseline lung function results were significantly associated with ventilation of the animal houses . Furthermore , temperature was related to spirometric findings in pig farmers . CONCLUSIONS Ventilation of the animal house and temperature might influence respiratory morbidity in farmers BACKGROUND Up to now potential health effects of environmental exposure to intensive livestock production facilities have not been thoroughly studied . The aim of the Lower Saxony Lung Study ( NiLS ) was to assess the prevalence of respiratory symptoms and disease in an area with intensive animal production facilities taking into account environmental exposure to emissions from these large-scale farms . METHODS All 10 864 inhabitants ( age 18 to 44 years ) of four towns with a large number of intensive animal production facilities in the area were invited to answer a mail-in question naire . Of these , 6416 subjects were r and omly selected for the clinical part of the study ( specific IgE , lung function measurements , bronchial provocation with methacholine ) . Overall , 6937 subjects answered the question naire ( 68 % ) , 60 % took part in the clinical tests . RESULTS The prevalence of allergic disease in the study population was lower than in urban citizens . Subjects with more than 12 animal houses within 500 m of their home had an increased odds ratio for wheezing without a cold ( odds ratio 2.7 ; 95 % confidence interval 1.4 - 5.4 ) . They also showed a significantly decreased FEV ( 1 ) ( mean 0.26 l ; 0.04 l - 0.48 l ) as well as a trend for a lower Tiffeneau-Index . CONCLUSIONS In result , a large number of intensive animal production facilities might be associated with decreased lung function results in the immediate neighbours . Further studies are necessary to confirm our findings Background : Despite public concern about potential adverse health effects of concentrated animal feeding operations , objective ly assessed data on environmental exposure to concentrated animal feeding operations and respiratory health are sparse . We aim ed to assess respiratory health in neighbors of confined animal feeding operations . Methods : A survey was done in 2002–2004 among all adults ( 18–45 years old ) living in 4 rural German towns with a high density of confined animal feeding operations . Question naire data were available for 6937 ( 68 % ) eligible subjects . In a r and om sample we measured the following outcomes : specific IgE to common and farm-specific allergens , lung function , and bronchial hyperresponsiveness to methacholine . Exposure was measured by collecting data on odor annoyance and geo-coded data on the number of animal houses within 500 m of the home . Locally optimal estimating and smoothing scatter plots were used to model the association between exposure and outcome . Analyses were restricted to subjects without private or professional contact with farming environments . Results : The prevalence of self-reported asthma symptoms and nasal allergies increased with self-reported odor annoyance . The number of animal houses was a predictor of self-reported wheeze and decreased forced expiratory volume in 1 second , but not allergic rhinitis or specific sensitization . Self-reported exposure and results of clinical measurements were poorly correlated . Conclusions : Confined animal feeding operations may contribute to the burden of respiratory disease among their neighbors . Our findings underline the importance of objective assessment of exposure and outcome in environmental epidemiology Numerous articles have been published regarding the adverse respiratory health consequences of working in intensive livestock and poultry housing . Threshold limit exposure guidelines are not currently applied to this environment , but they are essential to implement and monitor effective environmental controls . Previous dose-response research work with swine workers has result ed in exposure limit recommendations of 2.5 mg/m3 total dust , 0.23 mg/m3 respirable dust , 100 EU/m3 endotoxin , and 7 ppm ammonia . No similar recommendations have been reported previously for poultry workers . Therefore , an industry-wide study was conducted to examine dose-response relationships of bioaerosol exposures and worker respiratory health . A total of 257 poultry workers were studied for respiratory symptoms , pulmonary function , and exposure to dust ( total and respirable ) , endotoxin ( respirable and total ) , and ammonia . Details of the sampling plan and environmental assessment are described elsewhere . Relationships between exposures and response were studied by correlation and multiple regressions . Significant dose-response relationships were observed between exposures and pulmonary function decrements over a work shift . Exposure concentrations associated with significant pulmonary function decrements were as follows : 2.4 mg/m3 total dust , 0.16 mg/m3 respirable dust , 614 EU/m3 endotoxin , and 12 ppm ammonia BACKGROUND Exposure to swine dust leads to an intense airway inflammation and increased bronchial responsiveness . The purpose of the present study was to evaluate the effect of a respiratory protection device during exposure in a swine house . METHODS Twenty-two subjects , 11 with a respirator , were exposed . Symptoms , body temperature , nasal lavage , and a bronchial metacholine challenge were performed before and 7 hr after exposure . For exposure assessment a nasal sample r was evaluated . RESULTS The subjects with a respirator showed an attenuated inflammatory nasal response . An increase in bronchial responsiveness was observed in both groups , significantly greater in the unprotected group . The use of respirators reduced endotoxin exposure by more than 90 % ( assessed by nasal sample rs ) . CONCLUSION The use of a respirator attenuated the inflammatory response compared with an unprotected group . The minor effect on bronchial responsiveness suggests that gases and /or ultrafine particles may also be important factors Testing of lung function and bronchial reactivity , bronchoalveolar lavage ( BAL ) , and a skin prick test with a st and ard panel and six " swine " extracts obtained from swine and swine environment were performed in 20 r and omly selected nonsmoking swine confinement workers . In addition , blood sample s for detection of antibodies by the diffusion in gel-enzyme-linked immunosorbent assay ( DIG-ELISA ) technique and precipitating antibodies were drawn . Air sample s for measurement of dust and endotoxin levels were collected . All the farmers regarded themselves as healthy . The results were compared with reference groups consisting of urban nonsmoking subjects who had not been exposed to pig farming environment . The pig farmers had normal lung function and the bronchial reactivity was not different from the reference group . In the BAL fluid of the farmers , the concentration of total cells and granulocytes was increased while the concentrations of lymphocytes and macrophages were normal . The BAL fluid concentrations of albumin , fibronectin , and hyaluronan were elevated in the farmers . Skin prick tests with swine extracts were negative in all farmers . Antibodies ( assessed by DIG-ELISA ) against swine d and er , swine dust , and pig feed were increased and precipitating antibodies against swine d and er were found in 14 , against pig food in five , and against swine confinement dust in three of the 20 pig farmers . The concentration of airborne total dust was 7.4 mg/cu mm and the endotoxin concentration was 37 ( 22 to 60 ) ng/cu mm during tending the pigs and increased , during feeding , to 13.8 mg/cu mm and 315 ( 194 to 716 ) ng/cu mm , respectively . There was no correlation between exposure and lung function or lavage findings . In conclusion , r and omly selected pig farmers had signs of airway inflammatory reaction and activation of the immune system without alteration in lung function and bronchial reactivity A crossover trial was conducted to evaluate the acute human health effects of a dust control technology in a swine confinement facility . Twenty lifetime nonsmoking male subjects , with no evidence of allergy or asth
Output:
| The majority of occupational studies found a negative impact on respiratory health outcomes and increases in inflammatory biomarkers among farm workers exposed to bioaerosols .
Studies investigating the health of communities living near intensive farms had mixed findings .
The review indicated a potential impact of intensive farming on childhood respiratory health , based on a small number of studies using self-reported outcomes , but supported by findings from occupational studies . |
MS211888 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVES : To determine whether intravaginal clindamycin cream reduces the incidence of abnormal pregnancy outcome in women with abnormal vaginal microbial flora grade d as intermediate or BV and to investigate the effect of the antibiotic on vaginal microbial flora . METHODS : A prospect i ve cohort study of pregnant women in an antenatal clinic of a district general hospital . The subjects were 268 women who had abnormal vaginal microbial flora at first clinic visit by examination of a Gram-stained vaginal smear and 34 women with a normal vaginal flora . Two hundred and thirty-seven women were evaluable . Women with abnormal Gram-stained smears ( grade d as II or III ) on clinic recall were r and omised to receive treatment ( intravaginal clindamycin cream ) or placebo and followed to assess outcome of pregnancy , vaginal flora , and detection of Mycoplasma hominis and Ureaplasma urealyticum after treatment . RESULTS : Abnormal outcomes of pregnancy were not significantly different in treated and placebo groups by Chi square ( P = 0.2 ) . However , women with grade III flora responded better to clindamycin than women with grade II flora by numbers of abnormal outcomes ( P = 0.03 ) and return to normal vaginal flora ( P = 0.01 ) ( logistic regression analysis model ) . This may be due to differences in vaginal bacterial species in these grade s. Women whose abnormal vaginal flora had spontaneously returned to normal on follow-up and were therefore not treated ( revertants ) had as many abnormal outcomes as placebos suggesting that damage by abnormal bacterial species occurred early in pregnancy . CONCLUSIONS : Gram-stain screening distinguishing grade II from grade III flora may be helpful in prescribing treatment other than clindamycin for women with grade II flora . Earlier diagnosis and treatment may be more effective in preventing an abnormal outcome , possibly as soon as pregnancy is diagnosed or even offered as a pre-conception screen Abstract Objective To evaluate whether a screening strategy in pregnancy lowers the rate of preterm delivery in a general population of pregnant women . Design Multicentre , prospect i ve , r and omised controlled trial . Setting Non-hospital based antenatal clinics . Participants 4429 pregnant women presenting for their routine prenatal visits early in the second trimester were screened by Gram stain for asymptomatic vaginal infection . In the intervention group , the women 's obstetricians received the test results and women received st and ard treatment and follow up for any detected infection . In the control group , the results of the vaginal smears were not revealed to the caregivers . Main outcome measures The primary outcome variable was preterm delivery at less than 37 weeks . Secondary outcome variables were preterm delivery at less than 37 weeks combined with different birth weight categories equal to or below 2500 g and the rate of late miscarriage . Results Outcome data were available for 2058 women in the intervention group and 2097 women in the control group . In the intervention group , the number of preterm births was significantly lower than in the control group ( 3.0 % v 5.3 % , 95 % confidence interval 1.2 to 3.6 ; P = 0.0001 ) . Preterm births were also significantly reduced in lower weight categories at less than 37 weeks and ≤ 2500 g. Eight late miscarriages occurred in the intervention group and 15 in the control group . Conclusion Integrating a simple infection screening programme into routine antenatal care leads to a significant reduction in preterm births and reduces the rate of late miscarriage in a general population of pregnant women OBJECTIVE To assess the ability of clindamycin vaginal cream to reduce the incidence of preterm birth in women with abnormal genital tract flora in the second trimester of pregnancy . METHODS This was a r and omized , double-blind , placebo-controlled , tricenter study . A total of 409 women with abnormal genital tract flora on Gram stain of vaginal secretions at 13–20 weeks ' gestation were r and omized to receive a 3-day course of clindamycin vaginal cream or placebo . Those women who still had abnormal vaginal flora 3 weeks later received a 7-day course of the original study drug ( ie , either clindamycin vaginal cream or placebo as per original r and omization ) . The primary outcome measure was the incidence of preterm birth . RESULTS There was a statistically significant reduction in the incidence of preterm birth in the clindamycin vaginal cream group ( 4 % ) compared with placebo ( 10 % ) ( P < .03 ) . Significantly more babies born preterm ( 63 % ) required admission to the neonatal intensive care unit compared with term infants ( 4 % ) ( P < .001 ) . CONCLUSION A 2 % clindamycin vaginal cream , when compared with placebo administered to women with abnormal genital tract flora before 20 weeks ' gestation , can reduce the incidence of preterm birth by 60 % and hence the need for neonatal intensive care OBJECTIVE Our purpose was to analyze ( 1 ) the effects of prevalent lower reproductive tract infections and ( 2 ) the effect of systematic diagnosis and treatment to reduce risks of early pregnancy loss ( < 22 weeks ) , preterm premature rupture of membrances , and overall preterm birth . STUDY DESIGN A prospect i ve , controlled treatment trial was conducted on 1260 women . During the first 7 months of the program ( observation , phase I ) , women were examined at initiation of prenatal care for a panel of lower genital tract microorganisms and bacterial vaginosis . Women were followed up with reexaminations at 22 to 29 weeks and after 32 weeks ' gestation . The recommended treatments of the Centers for Disease Control ( i.e. , 300 mg of clindamycin orally twice daily for 7 days for bacterial vaginosis ) were used for infected women during the second 8 months of the study ( treatment , phase II ) . Data were analyzed according to intent to treat by means of univariate and multivariate methods . RESULTS Overall , presence of bacterial vaginosis ( 32.5 % ) at enrollment was associated with pregnancy loss at < 22 weeks ' gestation ( relative risk 3.1 , 95 % confidence interval 1.4 to 6.9 ) . Among women in the observation phase bacterial vaginosis was associated with increased risk of both preterm birth ( relative risk 1.9 , 95 % confidence interval 1.2 to 3.0 ) and preterm premature rupture of membranes ( relative risk 3.5 , 95 % confidence interval 1.4 to 8.9 ) . Within this population ( phase I ) 21.9 % of preterm birth overall ( 43.8 % premature rupture of membranes ) is estimated as attributable to bacterial vaginosis . Among women with bacterial vaginosis phase II ( treatment ) was associated with reduced preterm birth ( relative risk 0.5 , 95 % confidence interval 0.3 to 0.9 ) ; there was a similar reduction for women with preterm premature rupture of membranes ( relative risk 0.5 , 95 % confidence interval 0.2 to 1.4 ) . Women with both bacterial vaginosis and trichomoniasis were at highest risk of preterm birth ( 28 % ) ; treatment of both conditions ( phase II ) reduced preterm birth ( 17 % ) but did not eliminate this risk . Earlier patient enrollment and oral antibiotic treatment were associated with reduced preterm birth . CONCLUSIONS This prospect i ve , controlled trial confirms that the presence of bacterial vaginosis is associated with increased risks of pregnancy loss at < 22 weeks , preterm premature rupture of membranes , and preterm birth . Orally administered clindamycin treatment is associated with a 50 % reduction of bacterial vaginosis-linked preterm birth and preterm premature rupture of membranes . Women at risk for preterm birth or preterm premature rupture of membranes because of bacterial vaginosis or common genital tract infections should be screened , treated , reevaluated for cure , and re-treated if necessary BACKGROUND Pregnant women with bacterial vaginosis may be at increased risk for preterm delivery . We investigated whether treatment with metronidazole and erythromycin during the second trimester would lower the incidence of delivery before 37 weeks ' gestation . METHODS In 624 pregnant women at risk for delivering prematurely , vaginal and cervical cultures and other laboratory tests for bacterial vaginosis were performed at a mean of 22.9 weeks ' gestation . We then performed a 2:1 double-blind r and omization to treatment with metronidazole and erythromycin ( 433 women ) or placebo ( 191 women ) . After treatment , the vaginal and cervical tests were repeated and a second course of treatment was given to women who had bacterial vaginosis at that time ( a mean of 27.6 weeks ' gestation ) . RESULTS A total of 178 women ( 29 percent ) delivered infants at less than 37 weeks ' gestation . Eight women were lost to follow-up . In the remaining population , 110 of the 426 women assigned to metronidazole and erythromycin ( 26 percent ) delivered prematurely , as compared with 68 of the 190 assigned to placebo ( 36 percent , P = 0.01 ) . However , the association between the study treatment and lower rates of prematurity was observed only among the 258 women who had bacterial vaginosis ( rate of preterm delivery , 31 percent with treatment vs. 49 percent with placebo ; P = 0.006 ) . Of the 358 women who did not have bacterial vaginosis when initially examined , 22 percent of those assigned to metronidazole and erythromycin and 25 percent of those assigned to placebo delivered prematurely ( P = 0.55 ) . The lower rate of preterm delivery among the women with bacterial vaginosis who were assigned to the study treatment was observed both in women at risk because of previous preterm delivery ( preterm delivery in the treatment group , 39 percent ; and in the placebo group , 57 percent ; P = 0.02 ) and in women who weighed less than 50 kg before pregnancy ( preterm delivery in the treatment group , 14 percent ; and in the placebo group , 33 percent ; P = 0.04 ) . CONCLUSIONS Treatment with metronidazole and erythromycin reduced rates of premature delivery in women with bacterial vaginosis and an increased risk for preterm delivery Fourteen of 28 Trichomonas vaginalis isolates collected from patients in Guangzhou , China from 2003 to 2004 were found to be naturally infected with Mycoplasma hominis , as determined by PCR using specific primers . In vitro metronidazole sensitivity assay of the 28 isolates revealed four displaying low susceptibility [ minimum lethal concentration (MLC)=∼13–25 μg/ml ] and another four displaying high resistance ( MLC=50–100 μg/ml ) . The overwhelming majority of these resistant isolates ( 7/8 ) were mycoplasma-infected . The mean of MLCs of mycoplasma-infected isolates is ∼10-fold higher than the mean of noninfected isolates ( p=0.029 ) . Sequence analyses of PCR-amplified small subunit – large subunit rRNA interspacer regions ( ITS1/5.8S/ITS2 ) revealed that 23 of the 28 sample s are identical , the remaining five being separable into two groups , each with a single point mutation . These internal transcribed spacer sequence variants are associated neither with mycoplasma infection nor with drug resistance . In contrast , r and om amplified polymorphic DNA analyses of DNAs using 10 different primers showed that the drug-resistant isolates are clustered together in association with mycoplasma infection , albeit more loosely . Taken together , the results obtained from this study suggest that in vitro metronidazole resistance of T. vaginalis is related to mycoplasma infection of this protozoan BACKGROUND The ORACLE II trial compared the use of erythromycin and /or amoxicillin-clavulanate ( co-amoxiclav ) with that of placebo for women in spontaneous preterm labour and intact membranes , without overt signs of clinical infection , by use of a factorial r and omised design . The aim of the present study --the ORACLE Children Study II -- was to determine the long-term effects on children after exposure to antibiotics in this clinical situation . METHODS We assessed children at age 7 years born to the 4221 women who had completed the ORACLE II study and who were eligible for follow-up with a structured parental question naire to assess the child 's health status . Functional impairment was defined as the presence of any level of functional impairment ( severe , moderate , or mild ) derived from the mark III Multi-Attribute Health Status classification system . Educational outcomes were assessed with national curriculum test results for children resident in Engl and . FINDINGS Outcome was determined for 3196 ( 71 % ) eligible children . Overall , a greater proportion of children whose mothers had been prescribed erythromycin , with or without co-amoxiclav , had any functional impairment than did those whose mothers had received no erythromycin ( 658 [ 42.3 % ] of 1554 children vs 574 [ 38.3 % ] of
Output:
| Recently , a more focused SR&MA has demonstrated that antibiotics active against BV-related organisms , used in women whose risk of PTB is due to abnormal microflora , and used early in pregnancy before irreversible inflammatory damage has occurred , can reduce the rate of PTB . |
MS211889 | ***TASK*** the task is to summarize an input biomedical literature 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 Experimental evidence suggests that neutrophils and their metabolites play an important role in the pathogenesis of pyelonephritis . The aim of this study was to investigate the diagnostic value of polymorphonuclear elastase-a(1)-antitrypsin complex ( E-a(1)-Pi ) for the detection of acute pyelonephritis in children . METHODS Eighty-three patients , 29 boys and 54 girls , 25 days to 14 years of age , with first-time symptomatic urinary tract infection were prospect ively studied . Fifty-seven healthy children served as controls . Dimercaptosuccinic acid ( DMSA ) scan and voiding cystourethrography were performed in all patients . Plasma and urinary E-a(1)-Pi , C-reactive protein ( CRP ) , erythrocyte sedimentation rate ( ESR ) , neutrophil count , urinary N-acetyl-beta-glucosaminidase ( NAG ) , N-acetyl-beta-glucosaminidase b ( NAG b ) , and creatinine levels were measured in all patients on admission and 3 days after the introduction of antibiotics . The same markers were also measured in the control subjects . RESULTS Planar DMSA scintigraphy demonstrated changes of acute pyelonephritis in 30 of 83 children ( group A ) . It was normal in the remaining 53 children ( group B ) . The sex and age distributions were not significantly different between the 2 groups , as well as between the patients and the control subjects ( group C ) . Nineteen of the 53 children with a normal DMSA had body temperature > /=38 degrees C , whereas all but 4 children with abnormal DMSA had temperature > /=38 degrees C. Therefore , the temperature was significantly different between these 2 groups . The sensitivity and specificity of fever ( > /=38 degrees C ) as an indicator of renal involvement based on isotopic findings were 86 % and 64 % , respectively . Given the significant number of the febrile children with normal DMSA scintiscans , group B was subdivided into B(1 ) with 19 febrile children ( 14 boys and 5 girls ) and B(2 ) with 34 children whose body temperature was below 38 degrees C ( 8 boys and 26 girls ) . The sex and age distribution was significantly different between groups B(1 ) and B(2 ) . The mean age of group B(1 ) was.78 years ( range : 28 days to 9 years ; median:.25 years ; st and ard deviation : 2.1 ) . All but 1 child in this group were younger than 1 year of age . In contrast , in group B(2 ) , there were only 4 infants , the remaining 30 children were older than 2.5 years ( mean age : 6 years ; median : 7 years ; st and ard deviation : 3.5 ; range : 34 days to 12 years ) . The mean duration of fever before hospital admission was 2.8 days for group A and 1.8 days for group B(1 ) . This difference was not statistically significant . Similarly , body temperature was not significantly different between these 2 groups . The distribution of plasma E-a(1)-Pi values was normal in the control subjects . The sensitivity and specificity of plasma E-a(1)-Pi , as an indicator of renal involvement , were 96 % and 50 % , respectively , taking the 95th percentile of the reference range as a cutoff value . However , considering as a cutoff value the level of 72 microg/dL ( 95th percentile of group B(2 ) ) , its sensitivity and specificity were 74 % and 86 % , respectively . Plasma E-a(1)-Pi levels were significantly elevated in group A compared with group B and in both groups , the plasma E-a(1)-Pi values were significantly higher than in the control subjects . A significant difference also was noticed between group A and each of the subgroups B(1 ) and B(2 ) and also between the subgroups themselves . Plasma E-a(1)-Pi concentrations correlated significantly with neutrophil count in groups A ( r = .3 ) , B ( r = .4 ) , and B(2 ) ( r = .46 ) , but the correlation was not significant in group B(1 . ) ESR levels showed , among the different groups , similar differences with those of E-a(1)-Pi values . Unlike E-a(1)-Pi , CRP levels were comparable between groups A and B(1 ) , which both consisted of febrile children . Neutrophil count was not significantly different between subgroups B(1 ) and B(2 ) . ( ABSTRACT TRUNCATED Background . During the course of our routine renal ultrasound examinations , we noticed that some children who developed dilatation of a renal pelvis following voiding had reflux found on voiding cystourethrography ( VCUG ) . Purpose . To determine if increase in renal pelvic size on post-void ultrasound is an accurate predictor of vesicoureteral reflux . Material s and methods . Fifty-seven children ( 113 kidneys ) underwent renal ultrasound and VCUG on the same day . Anteroposterior dimensions of the renal pelves were prospect ively measured on ultrasound prior to and following patient voiding and correlated with the results of the VCUG . Results . The diameter of the renal pelvis increased in 12 and decreased in 38 kidneys on post-void ultrasound . Vesicoureteral reflux occurred in 19 kidneys and among these kidneys , renal pelvic diameter increased in 2 , decreased in 7 , and was unchanged in 10 following voiding . There was no significant correlation between post-void change in renal pelvic diameter and the presence of vesicoureteral reflux . Conclusion . Increase in renal pelvic size on post-void ultrasound is not a reliable indicator of vesicoureteral reflux UNLABELLED The results of serial dimercaptosuccinic acid ( DMSA ) imaging over 5 years are reported in 287 children with severe vesico-ureteral reflux entered into the European Branch of the International Reflux Study in Children . The children were r and omly allocated to medical ( n=147 ) or surgical ( n=140 ) management and DMSA studies were performed during the follow up period at least 6 months after any urinary tract infection . Abnormal images were classified into four types : ( 1 ) large polar hypodensity with normal renal outline ; ( 2 ) peripheral photon deficient defect(s ) in a non-deformed kidney ; ( 3 ) small renal image with normal contour ; and ( 4 ) peripheral defect(s ) with result ant irregularity of the renal outline . The DMSA findings were abnormal at entry in 235 ( 82 % ) with no difference in incidence or severity between the two treatment groups . During follow up , deterioration was observed in 25 medically and 23 surgically treated patients and comprised image deterioration alone in 17 , image deterioration with corresponding reduction in differential function in 16 and reduction in relative function without image change in 15 , with similar distribution between the two treatment groups . Deterioration was more frequent in children entering the study under the age of 2 years and in those with grade IV rather than grade III reflux . These findings , showing no difference in outcome between children managed surgically or medically , are consistent with the radiological results already published . CONCLUSION In the International Reflux Study the DMSA scintigraphic data showed no difference in outcome between children managed surgically or medically A prospect i ve blind study comparing the findings of ultrasonography , intravenous pyelography , and voiding cystourethrography was conducted on 81 patients to examine the place of ultrasonography in the initial radiologic evaluation of children with urinary tract infection . The patients ' mean age was 4.8 years ; 15 were male . Forty-eight were in patients ( mean age , 3.2 years ) and 33 were out patients ( mean age 7.2 years ) . In 29 patients ( 35.8 % ) abnormality of the urinary system was detected by one or more of the three imaging procedures ; 21 were in patients and eight were out patients . The most frequent finding was vesicoureteral reflux , occurring in 62.1 % of the pathologic cases . The findings at ultrasonography correlated well with those of intravenous pyelography in 73 of the 81 studies ( 90.1 % ) , but they failed to demonstrate double collecting systems and several of the minor changes . However , ultrasonography in combination with cystourethrography identified all patients who had abnormal urinary systems , except for two children with negligible findings . Moreover , ultrasonography and cystourethrography together identified all 11 patients , nine of them in patients , in whom surgical treatment was indicated . It is concluded that ultrasonography can successfully replace intravenous pyelography as a screening imaging procedure for the urinary system , but because of the superiority of intravenous pyelography in the detection of some types of lesions , intravenous pyelography will be required whenever ultrasonography or cystourethrography results are abnormal . ( ABSTRACT TRUNCATED AT 250 WORDS UNLABELLED Capabilities of color and power Doppler sonography ( DS ) were prospect ively evaluated for diagnosis of acute pyelonephritis and for prediction of scarring by comparison with 99mTc-dimercaptosuccinic acid scintigraphy ( DMSA ) . METHODS Fifty-seven children ( mean age , 5 + /- 3 y ) with acute pyelonephritis were investigated by biologic testing , DS ( DS 1 ) , and DMSA ( DMSA 1 ) . Patients who were < 6 mo old or had high- grade reflux or obstruction were excluded . Forty-five children had a clinical follow-up examination , biologic testing , DS ( DS 2 ) , and DMSA ( DMSA 2 ) at a mean of 7 + /- 2 mo after acute infection . Sonography ( gray-scale and DS ) was performed by 1 experienced radiologist who was unaware of patient data . DMSA studies were interpreted by 2 physicians who were unaware of patient data . RESULTS Temperature , neutrophil count , and C-reactive protein value were significantly higher in patients with abnormal DMSA 1 findings than in those with abnormal DS 1 findings ( P < 0.05 ) . When compared with DMSA 1 , DS 1 had a sensitivity and specificity of 80 % and 81 % , respectively . At follow-up , all clinical and biologic data had normalized . Scarring after infection occurred in 51 % of children . When compared with DMSA 2 , DS 1 had positive and negative predictive values of 57 % and 75 % , respectively , and DMSA 1 had respective values of 62 % and 100 % . Reflux was not considered a good predictor of scarring . CONCLUSION DS and DMSA results were concordant in 81 % of kidneys with acute pyelonephritis . The predictive value of DS for renal scarring was not considered sufficiently high for DS to be used in routine practice A system for defining renal scarring on ultrasound is proposed and compared with DMSA scintigraphy . Renal scarring was assessed with ultrasound in children following urinary tract infection ( UTI ) using the following criteria : ( 1 ) proximity of sinus echoes to cortical surface ; ( 2 ) loss of pyramids ; ( 3 ) irregularity of outline ; ( 4 ) loss of definition of capsular echo ; and ( 5 ) calyceal dilatation . Three hundred and thirty-nine consecutive ultrasound scans ( US ) and DMSA scintigrams , comprising 648 kidneys , were performed and reported blindly and the results were compared . Using DMSA scintigraphy as the gold st and ard , ultrasound had a positive predictive value of 93 % and a negative predictive value of 95 % . Ultrasound disagreed with DMSA scintigraphy in 5.2 % of kidneys . On review of the cases of disagreement where arbitration was possible by comparison with other imaging , ultrasound was incorrect in 10 kidneys and DMSA was incorrect in 13 . We conclude that the sensitivity in the ultrasound detection of renal scarring can be greatly improved using this method . If no scars were detected at ultrasound an alternative explanation for an abnormal DMSA scintigram should be sought This prospect i ve study was design ed to investigate the most relevant radiological approach for the evaluation of urinary tract infections ( UTI ) in childhood . In the first 48 hours following the diagnosis of UTI , all patients underwent99mTc dimercaptosuccinic acid ( DMSA ) scanning , ultrasonography ( US ) and intravenous urography ( IVU ) . For the imaging of renal parenchymal infection the sensitivity of IVU and US as compared to DMSA scanning were found to be 9.09 % and 25 % , respectively . It was concluded that99mTc DMSA , where available , should be the first step for the accurate diagnosis and follow-up of patients with UTI Abstract . This prospect i ve study , performed in 101 children with a first symptomatic urinary tract infection ( UTI ) , evaluates the diagnostic value of clinical , biological , and ultrasound parameters in detecting children with acute renal infection documented by dimercaptosuccinic acid ( DMSA ) scintigraphy . In children with a positive DMSA scan , mean C-reactive protein ( CRP ) was higher than in children with a normal DMSA scan ( 114±64 vs. 67±38 mg/dl , mean±SD , P=0.0002 ) . The sensitivity and specificity of CRP was 64 % and 68 % , respectively . In children with severe kidney involvement , mean CRP and white
Output:
| Conclusion There is no evidence to support the clinical effectiveness of routine investigation of children with confirmed UTI . |
MS211890 | ***TASK*** the task is to summarize an input biomedical literature 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: Abbreviations ACCORD Action to Control Cardiovascular Risk in Diabetes ADVANCE Action in Diabetes and Vascular Disease : Preterax and Diamicron Modified-Release Controlled Evaluation AGI α-Glucosidase inhibitor CAD Coronary artery disease CKD Chronic kidney disease CVD Cardiovascular disease DPP-4 Dipeptidyl peptidase IV GIP Glucose-dependent insulinotropic peptide GLP-1 Glucagon-like peptide 1 NPH Neutral protamine Hagedorn TZD Thiazolidinedione UKPDS UK Prospect i ve Diabetes Study VADT Veterans Affairs Diabetes Aim : Type II diabetes mellitus ( DM ) increases the risk of cardiovascular disease . Treatment with insulin substantially reduces C - reactive protein ( CRP ) because of its anti-atherosclerotic action . This study was design ed to explore and compare the cardio protective role of regular human insulin ( RHI ) , aspart and lispro insulin in type II DM . Material s and Methods : A r and omized , open , parallel group , comparative clinical study was conducted on 90 patients of type II DM . After baseline clinical assessment and investigations , RHI was prescribed to 30 patients , aspart insulin to 30 patients and lispro insulin to another 30 patients for 12 weeks . The efficacy variables were change in blood pressure , glycemic control , lipid profile , serum potassium , high-sensitivity CRP ( hsCRP ) and UKPDS 10-year CHD risk scoring over 12 weeks . At the end of the study , the patients were followed up and changes in variables from baseline were analyzed by statistical tools . Results : Systolic blood pressure decreased significantly in aspart group ( P = 0.008 ) whereas diastolic blood pressure was decreased significantly both in aspart ( P < 0.001 ) and lispro group ( P = 0.01 ) . Fasting , postpr and ial blood glucose and HbA1c were decreased in all three groups significantly but change in aspart group was superior ( P = 0.01 ) . Triglyceride was significantly better controlled by lispro ( P < 0.01 ) whereas aspart insulin was superior to decrease total cholesterol and LDL ( P < 0.05 ) . The extent of potassium loss was significantly more with RHI ( P = 0.004 ) than others . CRP-lowering effect ( P = 0.017 ) and decrease in UKPDS risk scoring ( P = 0.019 ) in aspart and lispro group was superior to RHI group . Conclusion : Short acting insulin analogues , especially aspart insulin have been found to have a better cardio protective role than RHI in type II DM OBJECTIVE Because there are limited data on the comparison of insulin aspart and mixed insulin in type 2 diabetes , this trial was performed to compare the efficacy and safety of prepr and ial insulin aspart with human soluble insulin ( HI ) and human premix ( 70 % NPH/30 % regular ) insulin ( MIX ) . RESEARCH DESIGN AND METHODS A total of 231 type 2 diabetic patients were r and omized to insulin aspart ( n = 75 ) , HI ( n = 80 ) , or MIX ( n = 76 ) for 3 months . Insulin aspart and HI were administered with or without bedtime NPH insulin . A total of 204 patients completed the trial according to protocol . HbA1c , 7-point blood glucose , insulin dosage , and hypoglycemic episodes were recorded . The primary end point was " change of HbA1c " from baseline to last visit . Analysis for equivalence was performed by t tests with three subtests . RESULTS HbA1c decreased 0.91 + /- 1.00 for insulin aspart , 0.73 + /- 0.87 for HI , and 0.65 + /- 1.10 for MIX with the following confidence intervals : insulin aspart HI ( -0.21 to 0.57 , P = 0.025 ) , insulin aspart MIX ( -0.17 to 0.69 , P = 0.092 ) , and HI-MIX ( -0.33 to 0.48 , P = 0.006 ) . Postpr and ial blood glucose decreased in the insulin aspart group : 0.44 mmol/l to > 1.67 mmol/l compared with HI and 1.1 mmol/l to > 1.67 mmol/l compared with MIX . Prepr and ial insulin doses were similar in the insulin aspart and HI groups ( 10 - 14.5 U ) . Hypoglycemic events per month were 0.56 HI , 0.40 insulin aspart , and 0.19 MIX . CONCLUSIONS Statistically , insulin aspart was not equivalent to another treatment in terms of HbA1c reduction . Insulin aspart treatment result ed in improved HbA1c and postpr and ial blood glucose . The application of insulin aspart was safe and well tolerated OBJECTIVE To compare the safety and efficacy of insulin aspart ( IAsp ) , buffered regular insulin ( BR ) , and insulin lispro administered by continuous subcutaneous insulin infusion ( CSII ) in patients with type 1 diabetes . RESEARCH DESIGN AND METHODS After completing a 4-week run-in period with BR , 146 adult patients with type 1 diabetes ( with pretrial CSII experience ) were r and omly assigned ( 2:2:1 ) to CSII treatment with IAsp , BR , or lispro for 16 weeks in a multicenter , open-label , r and omized , parallel-group study . Bolus insulin doses were administered 30 min before meals ( BR ) or immediately before meals ( IAsp or lispro ) . RESULTS Treatment groups had similar baseline HbA(1c ) ( 7.3 % + /- 0.7 for IAsp , 7.5 % + /- 0.8 for BR , and 7.3 % + /- 0.7 for lispro ) . After 16 weeks of treatment , HbA1c values were relatively unchanged from baseline , and the mean changes in baseline HbA1c values were not significantly different between the three groups ( 0.00 + /- 0.51 , 0.15 + /- 0.63 , and 0.18 + /- 0.84 for the IAsp , BR , and lispro groups , respectively ) . The rates of hypoglycemic episodes ( blood glucose < 50 mg/dl ) per patient per month were similar ( 3.7 , 4.8 , and 4.4 for the IAsp , BR , and lispro groups , respectively ) . Clogs/blockages in pumps or infusion sets were infrequent ; most subjects ( 76 , 83 , and 75 % in the IAsp , BR , and lispro groups , respectively ) had < or = 1 clog or blockage per 4 weeks during the trial . CONCLUSIONS Insulin aspart in CSII was as efficacious and well tolerated as BR and lispro and is a suitable insulin for continuous subcutaneous insulin infusion using external pumps BACKGROUND Severe hypoglycemia may increase the risk of a poor outcome in patients with type 2 diabetes assigned to an intensive glucose-lowering intervention . We analyzed data from a large study of intensive glucose lowering to explore the relationship between severe hypoglycemia and adverse clinical outcomes . METHODS We examined the associations between severe hypoglycemia and the risks of macrovascular or microvascular events and death among 11,140 patients with type 2 diabetes , using Cox proportional-hazards models with adjustment for covariates measured at baseline and after r and omization . RESULTS During a median follow-up period of 5 years , 231 patients ( 2.1 % ) had at least one severe hypoglycemic episode ; 150 had been assigned to intensive glucose control ( 2.7 % of the 5571 patients in that group ) , and 81 had been assigned to st and ard glucose control ( 1.5 % of the 5569 patients in that group ) . The median times from the onset of severe hypoglycemia to the first major macrovascular event , the first major microvascular event , and death were 1.56 years ( interquartile range , 0.84 to 2.41 ) , 0.99 years ( interquartile range , 0.40 to 2.17 ) , and 1.05 years ( interquartile range , 0.34 to 2.41 ) , respectively . During follow-up , severe hypoglycemia was associated with a significant increase in the adjusted risks of major macrovascular events ( hazard ratio , 2.88 ; 95 % confidence interval [ CI ] , 2.01 to 4.12 ) , major microvascular events ( hazard ratio , 1.81 ; 95 % CI , 1.19 to 2.74 ) , death from a cardiovascular cause ( hazard ratio , 2.68 ; 95 % CI , 1.72 to 4.19 ) , and death from any cause ( hazard ratio , 2.69 ; 95 % CI , 1.97 to 3.67 ) ( P<0.001 for all comparisons ) . Similar associations were apparent for a range of nonvascular outcomes , including respiratory , digestive , and skin conditions ( P<0.01 for all comparisons ) . No relationship was found between repeated episodes of severe hypoglycemia and vascular outcomes or death . CONCLUSIONS Severe hypoglycemia was strongly associated with increased risks of a range of adverse clinical outcomes . It is possible that severe hypoglycemia contributes to adverse outcomes , but these analyses indicate that hypoglycemia is just as likely to be a marker of vulnerability to such events . ( Funded by Servier and the National Health and Medical Research Council of Australia ; Clinical Trials.gov number , NCT00145925 . ) This r and omized , open-label , cross-over study compares the efficacy of mealtime rapid-acting analog insulin aspart with human insulin , in combination with metformin . A total of 30 patients with type 2 diabetes , inadequately controlled ( HbA(1c)>7.5 % ) with oral hypoglycemic agents ( OHAs ) , were assigned to human insulin 30 min before meals or aspart immediately before meals , both with metformin 500 mg t.i.d . for 90 days . Patients then switched to the alternate insulin . At 90 and 180 days , blood glucose and lipids were measured at baseline and every 30 min after test meals , for 3h . HbA(1c ) and hypoglycemic events were also assessed . After 3 months , HbA(1c ) was significantly reduced with aspart , but not human insulin ( -0.4+/-0.7 % versus + 0.1+/-0.7 % , p<0.05 ) . During meal tests , blood glucose area under the curve ( AUC ) was significantly lower with aspart than human insulin ( 1240+/-476 min/mmol/l versus 1588+/-766 min/mmol/l , p<0.01 ) . AUCs for lipids were similar for both treatments . Neither group experienced serious hypoglycemic events . These results encourage treatment with mealtime insulin aspart plus metformin , in type 2 diabetes patients with postpr and ial hyperglycemia inadequately controlled by OHAs alone Insulin aspart ( IAsp ) , is a rapid-acting analogue of human insulin ( HI ) , for use in the meal related treatment of diabetes mellitus . The degree of glycaemic control achieved by IAsp in comparison with HI after algorithm-driven dose optimisation was tested over 3 months . The prospect i ve , multicentre , r and omised , open-label study with parallel groups was performed in 48 centres in 11 countries and included 423 basal-bolus treated patients with Type 1 diabetes . Main outcome measures were blood glucose control assessed by HbA1c , nine-point self-monitored blood glucose profiles , insulin dose , quality of life , hypoglycaemia and adverse events . An algorithm-driven increase occurred in the dose and number of daily injections of basal insulin , particularly in the IAsp group . After 12 weeks of treatment , HbA1c was significantly lower in IAsp compared to HI treated subjects by 0.17 ( 95 % CI 0.30 - 0.04 ) ( P<0.05 ) . Comparison of the blood glucose profiles showed lower blood glucose levels with IAsp after breakfast ( mean 8.4 vs 10.1 mmol/l ; P<0.0001 ) and dinner ( 8.2 vs 9.3 mmol/l ; P<0.01 ) . There were no differences between treatments in the incidence of hypoglycaemic episodes or in the adverse event profiles . The WHO Diabetes Treatment Satisfaction Question naire score for perceived hyperglycaemia was lower with Iasp ( P=0.005 ) , and patients found the insulin aspart treatment more flexible ( P=0.022 ) . The current study underlines the need for optimising the basal
Output:
| The risk of overall hypoglycemia and severe adverse effects was comparable between the groups .
CONCLUSIONS IAsp provides better glycemic control when compared with RHI in patients with T1DM and T2DM .
Fewer T1DM patients treated with IAsp experienced nocturnal hypoglycemia , while both interventions showed a comparable risk of severe hypoglycemic events in both types of diabetes |
MS211891 | ***TASK*** the task is to summarize an input biomedical literature 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: Sixty-two consecutive patients with recurrent traumatic anterior instability of the shoulder were prospect ively observed . Thirty patients were observed after arthroscopic stabilization , and 32 were observed after open Bankart repair during a mean follow-up of 36 and 40 months , respectively ( range , 24 to 60 months for both groups ) . To reattach the labrum , the arthroscopic technique used transglenoid sutures and the open technique used bone anchors . Redislocation occurred in two patients ( 6 % ) in the open repair group and in five patients ( 17 % ) in the arthroscopic repair group . Three of the five patients with redislocations in the arthroscopic repair group underwent reoperation . According to the criteria of Rowe et al. , 29 patients ( 90.6 % ) who had open repair and 24 patients ( 80 % ) who had arthroscopic repair had good-to-excellent results . The patients averaged 90.6 points in the open repair group and 83.1 points in the arthroscopic repair group postoperatively . Little or no limitations in their postoperative sports activities were reported by 30 patients ( 94 % ) who underwent open repair and by 25 patients ( 83 % ) who had arthroscopic repair . Despite similar patient population s and using arthroscopic examination to select the type of repair in both groups , the results of arthroscopic shoulder stabilization are inferior to those of the classic open Bankart procedure BACKGROUND The prevalence and risk factors for recurrent instability and functional impairment following a primary glenohumeral dislocation remain poorly defined in younger patients . We performed a prospect i ve cohort study to evaluate these outcomes . We also aim ed to produce guidelines for the design of future clinical trials , assessing the efficacy of interventions design ed to improve the outcome after a primary dislocation . METHODS We performed a prospect i ve cohort study of 252 patients ranging from fifteen to thirty-five years old who sustained an anterior glenohumeral dislocation and were treated with sling immobilization , followed by a physical therapy program . Patients received regular clinical follow-up to assess whether recurrent instability had developed . Functional assessment s were made and were compared for two subgroups : those who had not had instability develop and those who had received operative stabilization to treat recurrent instability . RESULTS On survival analysis , instability developed in 55.7 % of the shoulders within the first two years after the primary dislocation and increased to 66.8 % by the fifth year . The younger male patients were most at risk of instability , and 86.7 % of all of the patients known to have recurrent instability had this complication develop within the first two years . A small but measurable degree of functional impairment was present at two years after the initial dislocation in most patients . Sample -size calculations revealed that a relatively small number of patients with a primary dislocation would be required in future clinical trials examining the effects of interventions design ed to reduce the prevalence of recurrent instability and improve the functional outcome . CONCLUSIONS Recurrent instability and deficits of shoulder function are common after primary nonoperative treatment of an anterior shoulder dislocation . There is substantial variation in the risk of instability , with younger males having the highest risk and females having a much lower risk . Future clinical trials to evaluate primary interventions should evaluate the prevalence of recurrent instability and functional deficits , with use of an assessment tool specifically for shoulder instability , during the first two years after the initial dislocation BACKGROUND Anterior dislocation of the glenohumeral joint in younger patients is associated with a high risk of recurrence and persistent functional deficits . The aim of this study was to assess the efficacy of a primary arthroscopic Bankart repair , while controlling for the therapeutic effects produced by the arthroscopic intervention and joint lavage . METHODS In a single-center , double-blind clinical trial , eighty-eight adult patients under thirty-five years of age who had sustained a primary anterior glenohumeral dislocation were r and omized to receive either an arthroscopic examination and joint lavage alone or together with an anatomic repair of the Bankart lesion . Assessment of the rate of recurrent instability , functional outcome ( with use of three scores ) , range of movement , patient satisfaction , direct health-service costs , and treatment complications was completed for eighty-four of these patients ( forty-two in each group ) during the subsequent two years . RESULTS In the two years after the primary dislocation , the risk of a further dislocation was reduced by 76 % and the risk of all recurrent instability was reduced by 82 % in the Bankart repair group compared with the group that had arthroscopy and lavage alone . The functional scores were also better ( p < 0.05 ) , the treatment costs were lower ( p = 0.012 ) , and patient satisfaction was higher ( p < 0.001 ) after arthroscopic repair . The improved functional outcome appeared to be mediated through the prevention of instability since the functional outcome in patients with stable shoulders was similar , irrespective of the initial treatment allocation . The patients who had a Bankart repair and played contact sports were also more likely to have returned to their sport at two years ( relative risk = 3.4 , p = 0.007 ) . CONCLUSIONS Following a first-time anterior dislocation of the shoulder , there is a marked treatment benefit from primary arthroscopic repair of a Bankart lesion , which is distinct from the so-called background therapeutic effect of the arthroscopic examination and lavage of the joint . However , primary repair does not appear to confer a functional benefit to patients with a stable shoulder at two years after the dislocation Background Nonoperative treatment of traumatic shoulder dislocations leads to a high rate of recurrent dislocations . Hypothesis Early arthroscopic treatment for shoulder dislocation will result in a lower recurrence rate than nonoperative treatment . Study Design Prospect i ve , r and omized clinical trial . Methods Two groups of patients were studied to compare nonoperative treatment with arthroscopic Bankart repair for acute , traumatic shoulder dislocations in young athletes . Fourteen nonoperatively treated patients underwent 4 weeks of immobilization followed by a supervised rehabilitation program . Ten operatively treated patients underwent arthroscopic Bankart repair with a bioabsorbable tack followed by the same rehabilitation protocol as the nonoperatively treated patients . The average follow-up was 36 months . Results Three patients were lost to follow-up . Twelve nonoperatively treated patients remained for follow-up . Nine of these ( 75 % ) developed recurrent instability . Six of the nine have required subsequent open Bankart repair for recurrent instability . Of the nine operatively treated patients available for follow-up , only one ( 11.1 % ) developed recurrent instability . Conclusions Arthroscopic stabilization of traumatic , first-time anterior shoulder dislocations is an effective and safe treatment that significantly reduces the recurrence rate of shoulder dislocations in young athletes when compared with conventional , nonoperative treatment PURPOSE The aim of this study was to evaluate , prospect ively , outcomes following arthroscopic Bankart repair performed with 2 types of suture anchor -- the G II ( DePuy Mitek , Raynham , MA ) nonabsorbable anchor and the Panalok ( DePuy Mitek ) absorbable anchor . METHODS Patients with a diagnosis of recurrent traumatic anterior instability of the shoulder who were seen in a single unit between April of 2000 and June of 2003 were considered for inclusion in the study . Patients were assessed preoperatively and postoperatively by means of a subjective , patient-related outcome measurement tool ( Oxford Instability Score ) , a visual analogue scale for pain and instability ( VAS Pain and VAS Instability ) , and a quality -of-life question naire ( Short Form-12 [ SF-12 ] ) . Length of follow-up was 1.5 to 5 years ( mean , 2.6 y ) . The incidence of recurrent instability and the level of sporting ability were recorded . Patients were r and omized to undergo surgical repair with nonabsorbable or absorbable anchors . RESULTS A total of 130 patients were included in this study , of whom 6 were lost to follow-up ; therefore 124 patients ( 95 % ) completed the study . Both types of anchor were highly effective . No differences in rate of recurrence or in any of the scores were noted between the 2 groups . In all , 4 patients in the nonabsorbable group and 3 in the absorbable group experienced additional episodes of dislocation after a traumatic event . Rate of redislocation in the whole series was therefore 6 % . In addition , 4 patients , all of them from the absorbable group ( 4 % ) , described ongoing symptoms of instability but no true dislocations . In all , 85 % of the patient group have returned to their previous level of sporting activity . CONCLUSIONS No differences in outcomes of arthroscopic Bankart repair were seen whether absorbable or nonabsorbable anchors were used . Both are highly effective , with a redislocation rate of 6 % . LEVEL OF EVIDENCE Level I , therapeutic r and omized controlled trial The purpose of this study was to compare patients with anterior shoulder instability who were treated with an open Bankart procedure with those treated with an arthroscopic procedure . During a 3-year period , 43 patients ( 44 shoulders ) were surgically treated . Thirty-four patients were available for followup . Eighteen shoulders had open Bankart procedure , and 16 shoulders were treated arthroscopically . Capsular laxity can be better assessed with the open procedure . A Bankart lesion was found in all the patients in both series . Average followup for Group 1 was 34 months , and for Group 2 , it was 23 months . Group 1 had 83 % good to excellent results with no recurrent dislocation or reoperation . Group 2 had 50 % good to excellent results , and 50 % fair to poor results with 3 recurrent dislocations and 4 recurrent subluxations that required second operation . The average loss of external rotation in Group 1 was not significantly greater than that in Group 2 . Sixteen patients in Group 1 and 8 patients in Group 2 were able to return to their primary work or sport . Results of arthroscopic Bankart repair do not equal those of the open Bankart procedure for the rate of recurrence and postoperative range of motion . The followup reported is short , and more dislocations can be anticipated with longer followup Abstract A total of 41 consecutive patients ( 11 women and 30 men , median age 29 ( 18–51 ) years ) with unilateral , isolated , posttraumatic , recurrent anterior shoulder dislocation and a Bankart lesion were operatively repaired , either by an arthroscopic technique including a capsular plication , or by an open procedure with Mitec anchors . All the patients were followed prospect ively and evaluated after a median of 36 ( 30–52 ) months follow-up by a “ blind ” observer . Nineteen patients in each group had excellent or good results , and one in each group was grade d as fair . One patient in the arthroscopic group had a traumatic dislocation 5 months after the operation and was grade d as poor . Three patients experienced subluxations postoperatively , one in the arthroscopic and two in the open group . There was no significant difference in anterior-posterior shoulder laxity measured objective ly with Donjoy . The open Bankart repair group had a statistically significantly longer hospitalization ( P = 0.001 ) , a slight decrease in external range of motion , and more frequent cosmetic complaints . Apart from this , the results revealed no major differences between the two methods after a median of 36 months in this selected group of patients with longst and ing problems We performed a prospect i ve study of 117 patients ( 119 shoulders ) with symptomatic , recurrent anterior post-traumatic shoulder instability to compare open versus arthroscopic reconstruction . Arthroscopic reconstructions ( N = 66 ) were performed using bioabsorbable tacks ( Suretac fixators ) , whereas open reconstructions ( N = 53 ) were performed with suture anchors . All of the patients had a Bankart lesion . Independent observers examined 108 of the 119 shoulders ( 91 % ) at a median follow-up period of 28 months ( range , 24 to 63 ) for the arthroscopic group and 36 months ( range , 24 to 63 ) for the open group . The recurrence rate , including both dislocations and subluxations , was 9 of 60 ( 15 % ) in the arthroscopic group , compared with 5 of 48 ( 10 % ) in the open group . At follow-up , the Rowe score was 93 points ( range , 39 to 100 ) and the Constant score was 91 points ( range , 56 to 100 ) in the arthroscopic group , compared with 89 points ( range , 53 to 100 and 57 to 100 for the Rowe and Constant scores , respectively ) for both scores in the open group . The only significant difference was in external rotation in abduction , which was 90 ° ( range , 50 ° to 135 ° ) in the arthroscopic group and 80 ° ( range , 25 ° to 115 ° ) in the open group . Both methods produced stable and well-functioning shoulders in the majority of patients PURPOSE The purpose of this study was to compare the results of arthroscopic and open repair of isolated Bankart lesions of the shoulder using metallic suture anchors . TYPE OF STUDY Prospect i ve r and omized clinical study . METHODS Sixty patients with traumatic anterior shoulder instability underwent a surgical repair of an isolated Bankart lesion . The patients were divided into 2 groups of 30 patients each . In group 1 , an arthroscopic repair was performed , and in group 2 , an open procedure was performed . The groups were homogeneous for gender , age , dominance , number of dislocations , time elapsed between first dislocation and surgery , and pathologic findings . In all cases of both groups , the lesion was repaired using metallic suture anchors carrying nonabsorbable braided sutures . Postoperative rehabilitation was the same for the 2
Output:
| There were no differences in recurrence or complication rate among patients undergoing surgery after the primary dislocation when compared with those undergoing surgery after multiple recurrent episodes .
Clinical outcome measures significantly improved within all independent studies from preoperatively to postoperatively . |
MS211892 | ***TASK*** the task is to summarize an input biomedical literature 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 : Nutrients in the one-carbon metabolism pathway may be involved in carcinogenesis . Few cohort studies have investigated the intakes of folate and related nutrients in relation to gastric and esophageal cancer . Methods : We prospect ively examined the association between self-reported intakes of folate , methionine , vitamin B6 , and vitamin B12 and gastric and esophageal cancer in 492 293 men and women . Results : We observed an elevated risk of esophageal squamous cell carcinoma with low intake of folate ( relative risk ( 95 % confidence interval ) : Q1 vs Q3 , 1.91 ( 1.17 , 3.10 ) ) , but no association with high intake . Folate intake was not associated with esophageal adenocarcinoma , gastric cardia adenocarcinoma , or non-cardia gastric adenocarcinoma . The intakes of methionine , vitamin B6 , and vitamin B12 were not associated with esophageal and gastric cancer . Conclusion : Low intake of folate was associated with increased risk of esophageal squamous cell carcinoma Evidence shows that there is a rapid increase in the production of markers of oxidative damage immediately following acute stroke and that endogenous antioxidant defences are rapidly depleted , thus permitting further tissue damage . Several studies point to an antioxidant effect of B-group vitamins and a pro-oxidant effect of elevated plasma tHcy ( total homocysteine ) . In the present study , we assessed whether supplementary B-group vitamins during this critical period will enhance antioxidant capacity and mitigate oxidative damage . Forty-eight patients with acute ischaemic stroke within 12 h of symptom onset were assigned to receive daily oral supplements of B-group vitamins comprising 5 mg of folate , 5 mg of vitamin B2 , 50 mg of vitamin B6 and 0.4 mg of vitamin B12 ( n=24 ) or no supplements ( n=24 ) for 14 days . The treatment group and controls were matched for stroke subtype and age . Blood sample s were obtained before intervention and also at 7 and 14 days post-recruitment for measurement of the following biomarkers : red cell folate ( whole blood folate corrected with haematocrit ) , erythrocyte glutathione reductase activity coefficient ( EGRAC ; measure of vitamin B2 status ) , plasma pyridoxal phosphate ( vitamin B6 status ) , plasma vitamin B12 , plasma alpha-tocopherol , plasma ascorbic acid , plasma TAOC ( total antioxidant capacity ) , plasma MDA ( malondialdehyde ) , plasma tHcy and CRP ( C-reactive protein ) . Supplementation for 14 days with B-group vitamins significantly increased the plasma concentrations of pyridoxal phosphate and red blood cell folate and improved a measure of B2 status compared with the control group ( P<0.05 ) . Plasma tHcy decreased in both groups albeit less in the control group , but differences in cumulative changes were not significant . There was , however , a decrease in plasma MDA concentration in the treatment group , in contrast with the increase seen in the control group and these differences were significant ( P=0.05 ) . CRP concentration , a marker of tissue inflammation , was significantly lower in the treatment group compared with controls ( P<0.05 ) . In conclusion , B-group vitamin supplementation immediately post-infa rct may have antioxidant and anti-inflammatory effects in stroke disease independent of a homocysteine-lowering effect BACKGROUND Evidence shows that there is a rapid increase in the production of markers of oxidative damage immediately after acute ischemic stroke and that endogenous antioxidant defenses are rapidly depleted , thus permitting further tissue damage . Several studies point to an antioxidant effect of B-group vitamins and a pro-oxidant effect of elevated total plasma homocysteine ( tHcy ) . METHODS To test whether supplementary antioxidants with or without B-group vitamins during this critical period enhance antioxidant capacity or mitigate oxidative damage , ninety-six acute ischemic stroke patients within 12 hours of symptom onset were r and omly assigned to receive either daily oral 800 IU ( 727 mg ) vitamin E and 500 mg vitamin C ( n = 24 ) , or B-group vitamins ( 5 mg folic acid , 5 mg vitamin B(2 ) , 50 mg vitamin B(6 ) , and 0.4 mg of vitamin B(12 ) ; n = 24 ) , both vitamins together ( n = 24 ) , or no supplementation ( n = 24 ) for 14 days . Treatment groups and controls were matched for stroke subtype and age . Blood was obtained before treatment , at day 7 , and day 14 for measurements of plasma or blood vitamin status , plasma total antioxidant capacity ( TAOC ) , malondialdehyde ( MDA ) , tHcy and C-reactive protein ( CRP ) . RESULTS Supplementation with antioxidant vitamins and B-group vitamins separately or together significantly increased the plasma concentration of vitamin C , E , pyridoxal phosphate ( B(6 ) status ) , red blood cell folate , and improved a measure of B(2 ) status ( red cell glutathione reductase activation coefficient [ EGRAC ] ) , compared with the control group . Plasma TAOC increased significantly in the antioxidant treatment groups compared with the nonsignificant decline seen in the control group . tHcy concentrations decreased in subjects who received B-group vitamins and the control group compared with the rise seen in those who received antioxidants alone . There was a significant reduction in plasma MDA concentration in the 3 treatment groups , in contrast to the increase seen in the control group ; however , the changes were most evident in antioxidant groups . CRP concentrations ( a marker of tissue inflammation ) were significantly lower in the 3 treatment groups compared with the control group . There were no additive or synergistic effects of antioxidants and B-group vitamins together on any outcome measure . CONCLUSIONS Antioxidants supplementation with or without B-group vitamins enhances antioxidant capacity , mitigates oxidative damage , and may have an anti-inflammatory effect immediately postinfa rct in stroke disease CONTEXT Recently , concern has been raised about the safety of folic acid , particularly in relation to cancer risk . OBJECTIVE To evaluate effects of treatment with B vitamins on cancer outcomes and all-cause mortality in 2 r and omized controlled trials . DESIGN , SETTING , AND PARTICIPANTS Combined analysis and extended follow-up of participants from 2 r and omized , double-blind , placebo-controlled clinical trials ( Norwegian Vitamin Trial and Western Norway B Vitamin Intervention Trial ) . A total of 6837 patients with ischemic heart disease were treated with B vitamins or placebo between 1998 and 2005 , and were followed up through December 31 , 2007 . INTERVENTIONS Oral treatment with folic acid ( 0.8 mg/d ) plus vitamin B(12 ) ( 0.4 mg/d ) and vitamin B(6 ) ( 40 mg/d ) ( n = 1708 ) ; folic acid ( 0.8 mg/d ) plus vitamin B(12 ) ( 0.4 mg/d ) ( n = 1703 ) ; vitamin B(6 ) alone ( 40 mg/d ) ( n = 1705 ) ; or placebo ( n = 1721 ) . MAIN OUTCOME MEASURES Cancer incidence , cancer mortality , and all-cause mortality . RESULTS During study treatment , median serum folate concentration increased more than 6-fold among participants given folic acid . After a median 39 months of treatment and an additional 38 months of posttrial observational follow-up , 341 participants ( 10.0 % ) who received folic acid plus vitamin B(12 ) vs 288 participants ( 8.4 % ) who did not receive such treatment were diagnosed with cancer ( hazard ratio [ HR ] , 1.21 ; 95 % confidence interval [ CI ] , 1.03 - 1.41 ; P = .02 ) . A total of 136 ( 4.0 % ) who received folic acid plus vitamin B(12 ) vs 100 ( 2.9 % ) who did not receive such treatment died from cancer ( HR , 1.38 ; 95 % CI , 1.07 - 1.79 ; P = .01 ) . A total of 548 patients ( 16.1 % ) who received folic acid plus vitamin B(12 ) vs 473 ( 13.8 % ) who did not receive such treatment died from any cause ( HR , 1.18 ; 95 % CI , 1.04 - 1.33 ; P = .01 ) . Results were mainly driven by increased lung cancer incidence in participants who received folic acid plus vitamin B(12 ) . Vitamin B(6 ) treatment was not associated with any significant effects . CONCLUSION Treatment with folic acid plus vitamin B(12 ) was associated with increased cancer outcomes and all-cause mortality in patients with ischemic heart disease in Norway , where there is no folic acid fortification of foods . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00671346 Abstract Purpose . The incidence of adenocarcinoma of the esophagus is increasing in most Western industrialized nations especially in white males . The impact of vitamins on the development of squamous cell carcinoma ( SCC ) and adenocarcinoma ( AC ) of the esophagus has not been eluci date d. The goal of this pilot- study was to analyze the influence of daily vitamin consumption on the frequency of esophageal carcinoma in Germany . Methods . Ninety-nine patients ( males ) with esophageal carcinoma ( 52 with SCC and 47 with AC ) were compared to a control group of 50 r and omly selected males from the Cologne area . Using a computer program to record the data , patients and controls were question ed in detail about their dietary habits . The interaction between known risk factors and the influence of vitamins on esophageal tumor risk were analyzed using logistic regression analysis . Results . The univariate analysis showed a significant risk reduction with increased intake of β-carotene , vitamin C , vitamin E , and folic acid for both AC and for SCC . The results of logistic regression analysis were compatible with the known risk factors for SCC ( alcohol and tobacco ) and for AC ( obesity , tobacco , and alcohol ) and showed a significant risk reduction with an intake of vitamin E greater than 13 mg/day ( RR=0.13 , 95 % CI=0.1–0.5 , P=0.0004 ) and vitamin C greater than 100 mg/day ( RR=0.33 , 95 % CI=0.11–0.92 , P=0.034 ) for patients with SCC and similar results for patients with AC . Conclusion . Our data showed that low intake of vitamin C and E correlates significantly with the development of squamous cell carcinoma as well as adenocarcinoma of the esophagus in males . The relevance of interaction of vitamins with other dietary factors , alcohol , and tobacco are topics of current research Objective This study aims to investigate the risk of esophageal squamous cell carcinoma in relation to exogenous factors in a rural area of China with a high incidence of esophageal squamous cell carcinoma . Methods A population -based case – control study was conducted in Yangzhong County , Jiangsu Province , China , with 355 histologically confirmed esophageal squamous cell carcinoma cases recruited between 1 January 2004 and 28 February 2006 and 408 controls matched by sex and age , r and omly selected from the local population . Results Stratified logistic regression analysis by sex revealed that hot-temperature food items , pork braised in brown sauce and old stocked rice intake could increase the risk of esophageal squamous cell carcinoma with odds ratio of 2.127 ( 95 % confidence interval : 1.394–3.245 ) , 2.059 ( 95 % confidence interval : 1.417–2.993 ) and 9.059 ( 95 % confidence interval : 5.930–13.840 ) , respectively , in men and 3.048 ( 95 % confidence interval : 1.733–5.364 ) , 1.914 ( 95 % confidence interval : 1.159–3.162 ) and 14.532 ( 95 % confidence interval : 7.816–27.019 ) , respectively , in women , whereas diet high in salt and chili , tobacco smoking and alcohol drinking only showed possible risk effects in men with odds ratio 2.338 ( 95 % confidence interval : 1.568–3.485 ) , 3.378 ( 95 % confidence interval : 2.117–5.389 ) , 1.976 ( 95 % confidence interval : 1.337–2.921 ) and 2.197 ( 95 % confidence interval : 1.510–3.195 ) , respectively . Green tea drinking showed a protective effect in women ( odds ratio=0.257 ; 95 % confidence interval : 0.070–0.94
Output:
| Conclusion These findings support that vitamin B may have an influence on carcinogenesis of the esophagus .
Vitamin B1 , B3 , B6 , B9 showed a decreased risk of EC , and vitamin B12 showed an increased risk of EC |
MS211893 | ***TASK*** the task is to summarize an input biomedical literature 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: Venous ulcers affect up to 1 % of the population . This review provides the hemodynamic , hematologic and clinical effects of intermittent pneumatic compression ( IPC ) in the treatment of venous ulcers . It presents the different IPCs and their application on venous disease . It points out that a large r and omized study on IPC versus st and ard four-layer compression in the treatment of venous ulcers is needed . The cost-effectiveness of IPC in the treatment of venous ulcers should also be assessed BACKGROUND Intermittent pneumatic compression ( IPC ) has been successfully used in the treatment of venous ulcers , although the optimal setting of pressure , inflation and deflation times has not yet been established . The aim of this study was to compare the effect of two different combinations of IPC pump setting s ( rapid vs slow ) in the healing of venous ulcers . MATERIAL / METHODS 104 patients with pure venous ulcers were r and omized to receive either rapid IPC or slow IPC for one hour daily . The primary and secondary end points were the complete healing of the reference ulcer and the change in the area of the ulcer over the six months observational period , respectively . RESULTS Complete healing of the reference ulcer occurred in 45 of the 52 patients treated with rapid IPC , and in 32 of the 52 patients treated with slow IPC . Life table analysis showed that the proportion of ulcers healed at six months was 86 % in the group treated with the fast IPC regimen , compared with 61 % in the group treated with slow IPC ( p=0.003 , log-rank test ) . The mean rate of healing per day in the rapid IPC group was found to be significantly faster compared to the slow IPC group ( 0.09 cm2 vs 0.04 cm2 , p=0.0002 ) . CONCLUSIONS Treatment with rapid IPC healed venous ulcers more rapidly and in more patients than slow IPC . Both IPC treatments were well tolerated and accepted by the patients . These data suggest that the rapid IPC used in this study is more effective than slow IPC in venous ulcer healing OBJECTIVE It has been previously shown that the SCD Response Compression System , by sensing the postcompression refill time of the lower limbs , delivers more compression cycles over time , result ing in as much as a 76 % increase in the total volume of blood expelled per hour . Extended indications for pneumatic compression have necessitated the introduction of portable devices . The aim of our study was to test the hemodynamic effectiveness of a new portable sequential compression system ( the SCD Express ) , which has the ability to detect the individual refill time of the two lower limbs separately . METHODS This was an open , controlled trial with 30 normal volunteers . The new SCD Express was compared with the SCD Response Compression System in the supine and semirecumbent positions . The refilling time sensed by the device was compared with that determined from velocity recordings of the superficial femoral vein using duplex ultrasonography . Baseline and augmented flow velocity and volume flow , including the total volume of blood expelled per hour during compression with the SCD Express , were compared with those produced by the SCD Response compression system in the same volunteers and positions . RESULTS Both devices significantly increased venous flow velocity as much as 2.26 times baseline in supine position and 2.67 times baseline in semirecumbent position ( all P < .001 ) . There was a linear relationship between duplex ultrasonography-derived refill time and the SCD Express-derived refill time in both the supine ( r = 0.39 , P = .03 ) and semirecumbent ( r = 0.71 , P < .001 ) positions but not with the SCD Response . Refill time measured by the SCD Express device was significantly shorter and the cycle rate higher in comparison with the SCD Response in both positions . The single-cycle flow velocity and volume flow parameters generated by the two devices were similar in both positions . However , median ( interquartile range ) total volume of blood expelled per hour was slightly higher with the SCD Express device in the supine position ( 7206 mL/h [ range , 5042 - 8437 ] vs 6712 mL/h [ 4941 - 10,676 ] ; P = .85 ) and semirecumbent position ( 4588 mL/h [ range , 3721 - 6252 ] vs 4262 mL/h [ 3520 - 5831 ] ; P = .22 ) . Peak volume of blood expelled per hour by the SCD Express device in the semirecumbent position was significantly increased by 10 % in comparison with the SCD Response ( P = .03 ) . CONCLUSIONS Flow velocity and volume flow enhancement by the SCD Response and SCD Express were essentially similar . The latter , a portable device with optional battery power that detects the individual refill time of the lower limbs separately , is anticipated to be associated with improved overall compliance and therefore optimized thromboprophylaxis . Studies testing its potential for improved efficacy in preventing deep vein thrombosis are justified Intermittent pneumatic leg compression ( IPC ) increases arterial calf inflow and foot skin blood flux in normal subjects and claudicants . Our hypothesis was that IPC could enhance foot skin blood flux after infrainguinal grafting and thus promote distal perfusion in limbs with tissue loss . The aim of this study was to compare the effects of three IPC modes [ applied to the foot ( IPCfoot ) , the calf ( IPCcalf ) , or both ( IPCfoot+calf ) ] on foot skin perfusion in healthy individuals , claudicants , and patients after infrainguinal arterial revascularization performed for critical or subcritical limb ischemia . Altogether , 20 healthy limbs , 22 claudicating limbs , and 36 limbs of arteriopaths with prior successful autologous femoropopliteal and femorodistal ( 18 each ) grafts were examined . Five-minute laser Doppler recordings were obtained from the pulp of the big toe in the sitting position , at rest , and during r and om applications of IPCfoot , IPCcalf , and IPCfoot+calf delivered at 120 mmHg for 4 seconds three times per minute . Foot skin blood flux increased using all IPC modes ( p < 0.001 ) , with IPCfoot and IPCfoot+calf generating higher flux levels than IPCcalf ( p < 0.01 ) in all groups . Intergroup differences of flux with each of the three IPC modes were not significant . IPCfoot and IPCfoot+calf similarly ( p > 0.14 ) produced a higher percentage flux increase than IPCcalf in all groups ( p < 0.004 ) . Controls had a higher percentage flux increase with both IPCcalf and IPCfoot than did claudicants ( p ≤ 0.016 ) . No differences were documented between normal and grafted limbs ( p > 0.05 ) . The percentage flux increase with IPCfoot+calf and IPCcalf was significantly higher in femorodistal grafts than in femoropopliteal ones ( p ≤ 0.026 ) . IPC enhances skin blood flux in limbs with infrainguinal bypass , claudication , and normal arteries , with IPCfoot and IPCfoot+calf being more effective than IPCcalf . Our findings suggest that IPC may be beneficial in limbs with impaired distal perfusion and thus may have clinical implication s in the treatment of leg ulcers either prior to or after revascularization BACKGROUND The purpose of the present paper was to compare healing rate and leg swelling with an intermittent compression pump versus compression b and ages in the treatment of venous leg ulcers , and to also compare patient compliance and satisfaction with the two techniques . METHODS A r and omized cross-over study of patients attending an outpatient wound clinic ( n = 16 ) was undertaken . A regular monthly follow-up with measurement of ulcer size and leg volume was carried out , as well as completion of a question naire . RESULTS Assessment was possible in 11 of the 16 patients . There was no significant difference between treatment types with regards to ulcer healing rates or control of leg oedema . The survey revealed that patients found the pump easier and more comfortable to use , with a trend towards increased compliance . CONCLUSIONS Although the present study was too small for generalizable conclusions , compression pumps and b and ages are comparable in efficacy for the healing of venous leg ulcers . The compression pump is reported as being easier and more comfortable to use than b and ages OBJECTIVES To test the hypothesis that the SCD EXPRESS intermittent pneumatic compression applied in combination with a four-layer b and age in patients with venous ulcers increases popliteal vein volume flow and velocity . DESIGN Twenty limbs of 18 patients with venous leg ulcers were studied , median age 76 years . The Total Volume Flow ( TVF ) and the Peak Systolic Velocity ( PSV ) were recorded in the popliteal vein using duplex ultrasonography . Measurements were made ( i ) without b and age , ( ii ) with four layer b and age and ( iii ) following the application of the SCD Compression System on top of a four-layer b and age for at least 15 minutes . RESULTS The median VCSS was 17 ( range , 12 - 22 ) while the median VSDS for reflux was 4.5 ( range , 1 - 7.5 ) . The median TVF was 71 mL/min ( inter-quartile range 57 - 101 ) without b and age , 112 ( IQR 89 - 148 ) with four-layer b and age and 291 ( IQR 241 - 392 ) with the addition of the SCD System ( P<.001 , Wilcoxon signed ranks test ) . The median PSV was 8.4 cm/sec ( IQR 6.8 - 14 ) without b and age , 13 ( 9.0 - 19 ) with four-layer b and age and 27 ( 21 - 31 ) with the addition of the SCD System ( P<.001 , Wilcoxon signed ranks test ) . Both TVF and PSV increased slightly with the addition of the four-layer b and age . However , with the addition of the SCD System these parameters increased three fold . CONCLUSIONS The SCD EXPRESS Compression System accelerates venous flow in the legs of patients with venous ulcers already treated with a four-layer b and age . The combination of four-layer compression with the SCD System on healing venous ulcers needs to be tested by a clinical effectiveness study Compression therapy -- including inelastic , elastic , and intermittent pneumatic compression -- is the st and ard of care for venous ulcers ( VLUs ) and chronic venous insufficiency , but there is no consensus in the literature regarding the most effective type of compression therapy . A prospect i ve , r and omized , clinical pilot study was conducted among 70 patients with unilateral VLUs treated in a hospital dermatology department in Pol and to compare three types of compression therapy ( intermittent pneumatic compression , stockings , and short-stretch b and ages ) in persons with superficial deep venous reflux alone or combined with the segmental variety . Study endpoints were change in ulcer dimensions and proportions healed . Patients with superficial or combined superficial and deep vein insufficiency were r and omly allocated to receive one of the three therapies ( one of each vein type for each treatment option , six groups total ) . All patients received saline-soaked gauze dressings along with micronized purified flavonoid fraction , diosmin , hesperidin , and Daflon 500 once daily . Compression treatments were changed or pneumatic compression provided daily for 15 days . Wound size reduction and percentage of wounds healed were significantly higher in groups receiving intermittent pneumatic compression or stockings than in groups using short-stretch b and ages ( for percentage change of ulcer surface area , P = 0.02 ; for healing rates P = 0.01 ) . These results warrant additional r and omized controlled clinical studies with a larger sample size and longer patient follow-up BACKGROUND A number of different treatment approaches have been recommended for the treatment of venous ulceration , including local ulcer treatment , compression and drug therapy . Recent advances in tissue engineering have result ed in living tissues being developed for cutaneous wound repair and skin replacement . The aim of this pilot study was to compare the rate of healing of venous ulcers in patients treated with Dermagraft ( a human fibroblast-derived dermal replacement ) and compression therapy or compression therapy alone . METHODS A total of 18 patients with venous ulceration of the leg were recruited into the pilot study . Ten patients were treated with Dermagraft and compression therapy , and eight patients were treated with compression therapy alone . Healing was assessed by ulcer tracing and computerised planimetry . Skin perfusion was measured by laser Doppler . RESULTS Five ( 50 % ) of the patients treated with Dermagraft and one ( 12.5 % ) control patient had healed by the end of the 12-week study period ( NS ) . The total ulcer area rate of healing and linear rate of healing was significantly improved in patients treated with Dermagraft ( P=0.001 and P=0.006 , respectively , Mann-Whitney U-test ) . The number of capillaries increased in both the treatment and control group . Peri-ulcer skin perfusion increased by 20 % in patients treated with Dermagraft , compared with 4.9 % in the control group . CONCLUSION The data from this small pilot study suggests that Dermagraft is associated with improved healing of venous ulceration . Following this pilot study , further clinical studies are needed to confirm the validity of these results in ' hard to heal ' venous leg ulcers Despite improvements in healing rates venous ulcer disease still carries significant morbidity and cost . Any therapy that further improves healing rates is worthy of consideration . The recognised effects of intermittent pneumatic compression ( IPC ) on both arterial and venous
Output:
| IPC may increase healing compared with no compression .
It is unclear whether it can be used instead of compression b and ages .
There is some limited evidence that IPC may improve healing when added to compression b and ages . |
MS211894 | ***TASK*** the task is to summarize an input biomedical literature 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 European Hernia Society ( EHS ) is proud to present the EHS Guidelines for the Treatment of Inguinal Hernia in Adult Patients . The Guidelines contain recommendations for the treatment of inguinal hernia from diagnosis till aftercare . They have been developed by a Working Group consisting of expert surgeons with representatives of 14 country members of the EHS . They are evidence -based and , when necessary , a consensus was reached among all members . The Guidelines have been review ed by a Steering Committee . Before finalisation , feedback from different national hernia societies was obtained . The Appraisal of Guidelines for REsearch and Evaluation ( AGREE ) instrument was used by the Cochrane Association to vali date the Guidelines . The Guidelines can be used to adjust local protocol s , for training purpose s and quality control . They will be revised in 2012 in order to keep them up date d. In between revisions , it is the intention of the Working Group to provide every year , during the EHS annual congress , a short up date of new high-level evidence ( r and omised controlled trials [ RCTs ] and meta-analyses ) . Developing guidelines leads to questions that remain to be answered by specific research . Therefore , we provide recommendations for further research that can be performed to raise the level of evidence concerning certain aspects of inguinal hernia treatment . In addition , a short summary , specifically for the general practitioner , is given . In order to increase the practical use of the Guidelines by consultants and residents , more details on the most important surgical techniques , local infiltration anaesthesia and a patient information sheet is provided . The most important challenge now will be the implementation of the Guidelines in daily surgical practice . This remains an important task for the EHS . The establishment of an EHS school for teaching inguinal hernia repair surgical techniques , including tips and tricks from experts to overcome the learning curve ( especially in endoscopic repair ) , will be the next step . Working together on this project was a great learning experience , and it was worthwhile and fun . Cultural differences between members were easily overcome by educating each other , respecting different views and always coming back to the principles of evidence -based medicine . The members of the Working Group would like to thank the EHS board for their support and especially Ethicon for sponsoring the many meetings that were needed to finalise such an ambitious project A prospect i ve study was carried out to determine the incidence of wound infection following surgery for inguinal hernia repair in a day surgery unit . The study incorporated surveillance for 1 month postoperatively . All patients were contacted by telephone , and reports of possible wound infection investigated via their General Practitioners . Ninety-seven patients were included in the study and the infection rate was 4 % A blinded r and omized clinical trial was undertaken to evaluate the effect of applying ointment to a wound before occlusive dressing , in comparison with no ointment or sterile paraffin Two hundred patients in a major Indian hospital who were undergoing clean operations participated in a prospect i ve , r and omised , controlled clinical trial of the effectiveness of systemic antibiotics in preventing wound infectious . Of the patients on antibiotics 12.6 % developed wound infections and of those not on antibiotics 13.3 % did -- a difference of no significance . Other factors analysed which included age , duration of operation , place on the operating list and length of the incision did not appear to effect the incidence of infection . Wound infection delayed the discharge of the patient from hospital by seven days . Avoiding antibiotic prophylaxis in these operations would have saved our hospital 12,500 pounds a year . We suggest that prophylactic antibiotics are ineffective in preventing wound infection after clean operations in India . Their use is wasteful and should be discouraged In a series of 762 general surgical wounds 376 were selected at r and om to receive three parenteral doses of cephaloridine and 386 remained as untreated controls . In all types of operation , with the exception of wounds in the lower extremities associated with arterial surgery , the rate of wound infection was lowered by the prophylactic use of cephaloridine . The results were statistically significant for total wounds , clean wounds , total contaminated wounds , and contaminated wounds other than in colorectal surgery . We therefore recommend the routine use of three doses of cephaloridine In a r and omised controlled prospect i ve trial , different antibiotic regimens were evaluated as prophylaxis in wound infection following elective surgical procedures . Four hundred and four consecutive cases were divided in four groups . Two groups were allotted two different conventional postoperative antibiotic regimens while the fourth group received short term perioperative antibiotic ; group one served as control . A higher frequency of postoperative wound infection was observed in the controls . Results showed reduction in gross infection in only group III where short term perioperative antibiotic was used . Combination of penicillin and streptomycin were not found effective , and low infection rate was observed with Cephamendole used perioperatively Abstract . Antibiotic prophylaxis is not routinely given for nonimplant , clean operations , although this view has recently been challenged . We have conducted a r and omized multicenter , double-blind prospect i ve trial to compare co-amoxiclav with placebo in 619 patients undergoing open groin hernia repair . Altogether 563 ( 91 % ) patients fulfilled the protocol ; 283 received co-amoxiclav and 280 placebo . There was no difference between the groups in the number of patients receiving local or general anesthetic , the type of repair performed , the use of a subcutaneous fat suture , the type of skin closure used , the use of wound analgesia , or the use of a wound drain . Patients were given a card to return to the hospital in the event of their wound discharging or their needing to see their general practitioner . All patients were review ed at approximately 6 weeks after operation . Fifty ( 8.9 % ) patients sustained a wound infection , 25 in the co-amoxiclav group and 25 in the placebo group . We conclude that antibiotic prophylaxis is of no benefit to patients undergoing open groin hernia repair Objective To assess the value of single-dose , intravenous , prophylactic ampicillin and sulbactam ( AS ) in the prevention of wound infections during open prosthetic inguinal hernia repair by a double-blind , prospect i ve , r and omized trial . Summary Background Data The use of antibiotic prophylaxis during open prosthetic inguinal hernia surgery is controversial , and no prospect i ve trial has been conducted to examine this issue . Methods Patients undergoing unilateral , primary inguinal hernia repair electively with the Lichtenstein technique using polypropylene mesh were r and omized to receive 1.5 g intravenous AS before the incision or an equal volume of placebo according to a predetermined code of which the surgeons were unaware . Patients with recurrent , femoral , bilateral , giant , or incarcerated hernias or any systemic diseases were excluded . Age , sex , body mass index , American Society of Anesthesiologists score , type of hernia , type of anesthesia , duration of surgery , and use of drains were recorded . Infection was defined according to the criteria of Centers for Disease Control . Patients were evaluated 1 week , 1 month , 6 months , and 1 year after surgery by an independent surgeon . All complications were recorded . Results were assessed using chi-square , Fisher ’s exact , and Student t tests as appropriate . Results Between September 1996 and July 1998 , 280 patients ( 140 AS , 140 placebo group ) entered the protocol . Four patients from the AS group and seven from the placebo group were excluded because of inadvertent antibiotic administration or follow-up problems . Groups were well matched for all the variables studied and postoperative complications , excluding wound infections , which occurred at a rate of 0.7 % in the AS group and 9 % in the placebo group ( P = .00153 ) . Twelve patients in the placebo group developed wound infections , requiring five repeat hospital admissions in three patients . These three patients suffered deep infections reaching the graft , which result ed in graft loss in two . The single infected patient in the AS group had his graft removed as well because of deep persistent infection . Conclusions This study documented a significant ( 10-fold ) decrease in overall wound infections when single-dose , intravenous AS was used during Lichtenstein hernia repair . Deep infections and wound infection-related readmissions were also reduced by the use of AS . Proponents of mesh repairs may therefore be advised to use prophylactic single-dose intravenous antibiotic coverage in the light of the results of this trial . AS proved to be an effective antimicrobial agent BACKGROUND Prophylactic antibiotics are recommended for clean-contaminated and selected contaminated surgery . In clean surgery antibiotics are suggested if the operation involves the insertion of prosthetic devices and a potential infection is expected to cause serious morbidity or mortality . Inguinal hernia repair is a clean operation , infections are rare ; they can usually be cured without removing the prosthesis and recurrence is uncommon even after removal of the mesh . Aim of the study is to evaluate whether the lack of antimicrobial prophylaxis increases the risk of postoperative infections in patients treated for groin hernia , compared to those treated with prophylaxis . METHODS One hundred and forty-eight patients underwent inguinal hernia repair with mesh : 64 patients ( 43 % ) received 2 g cefotaxime by intravenous bolus about 30 minutes before the operation , 84 patients ( 57 % ) did not receive any antimicrobic prophylaxis . Mean follow-up was 13 months ( range 1 - 31 months ) for both groups . RESULTS We did not observe any major complication . Among both groups , no patient had developed infection at one week and one month after surgery . CONCLUSIONS In personal experience , any advantage in terms of prevention of infections with antibiotic prophylaxis in patients operated on for groin hernia has been observed . A review of the literature showed no general agreement on this subject with different risk of infections in different trials . A new prospect i ve r and omized trial is necessary to clarify this topic A study was made of the risk factors causing a high incidence of surgical wound infections in clean operations . Identification of these factors in the preoperative stage allows the patients to be divided into two categories : a high risk ( about 10 % of patients for surgery ) and low risk . By giving antibiotic prophylaxis only to patients at high risk , the incidence of postoperative infections can be reduced , decreasing the number of extra days in hospital and consequently lowering costs . This is a new approach to the problem of surgical wound infections since not only is it based on the usual classification of operations into clean , clean-contaminated , contaminated and dirty , but it also takes into account the defensive capacity of the target of the infection : the patient Mesh prosthesis , local anesthesia , and ambulatory care have been widely introduced in recent decades in the treatment of inguinal hernia . The use of antibiotic prophylaxis during open inguinal hernia repair has been controversial . No prospect i ve trial has been conducted to assess the role of antibiotic prophylaxis in patients operated on for inguinal hernia under the above-mentioned conditions . A prospect i ve , r and omized , double-blinded trial was initiated to assess the efficacy of antibiotic prophylaxis in the prevention of wound infection during open mesh inguinal hernia repair under local anesthesia on an ambulatory basis . Ninety-nine consecutive hernia repairs were r and omized to receive 1 g of parenteral Cefazolin preoperatively or a placebo . No wound infections existed in the therapeutic group ( 0/50 ) . Four infections appeared in the control group ( 4/49 ) , and the study was suspended for ethical reasons when differences reached values close to statistical significance ( P=0.059 ) . We conclude that a single dose of intravenous Cefazolin decreases the risk of wound infection during open mesh inguinal hernia repair under local anesthesia on an ambulatory basis Objective : To determine whether the use of prophylactic antibiotics is effective in the prevention of postoperative wound infection after Lichtenstein open mesh inguinal hernia repair . Summary Background Data : A recent Cochrane meta- analysis ( 2003 ) concluded that “ antibiotic prophylaxis for elective inguinal hernia repair can not be firmly recommended or discarded . ” Methods : Patients with a primary inguinal hernia scheduled for Lichtenstein repair were r and omized to a preoperative single dose of 1.5 g intravenous cephalosporin or a placebo . Patients with recurrent hernias , immunosuppressive diseases , or allergies for the given antibiotic were excluded . Infection was defined using the Centers for Disease Control and Prevention criteria . Results : We included 1040 patients in the study between November 1998 and May 2003 . According to the intention-to-treat principle , 1008 patients were analyzed . There were 8 infections ( 1.6 % ) in the antibiotic prophylaxis group and 9 ( 1.8 % ) in the placebo group ( P = 0.82 ) . There was 1 deep infection in the antibiotic prophylaxis group and 2 in the placebo group ( P = 0.57 ) . Statistical analysis showed an absolute risk reduction of 0.19 % ( 95 % confidence interval , −1.78%–1.40 % ) and a number needed to treat of 520 for the total number of infections . For deep infection , the absolute risk reduction is 0.20 % ( 95 % confidence interval ,
Output:
| Based on the results of this systematic review the administration of antibiotic prophylaxis for elective inguinal hernia repair can not be universally recommended .
Neither can the administration be recommended against when high rates of wound infection are observed |
MS211895 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias Objectives : Examining the effects of tracheal suctioning on cerebral hemodynamics of normotensive ventilated very low birth weight ( VLBW ) infants with normal cranial ultrasounds ; determining the factor(s ) influencing changes in mean cerebral blood flow velocity ( CBFv ) after suctioning . Methods : Seventy-three VLBW infants had continuous monitoring of mean arterial blood pressure ( MABP ) , PaCO2 , PaO2 and mean CBFv before , during , and after 202 suctioning sessions during the first week of life . Peak ( or nadir ) and relative changes of the four variables for 45 min after suctioning were calculated . Multiple linear regression was used to determine the factor(s ) influencing changes in mean CBFv after suctioning . Result : Birth weight was 928±244 g ; gestational age was 27.0±2.0 weeks . Mean CBFv increased to 31.0±26.4 % after suctioning and remained elevated for 25 min . PaCO2 was highly associated with mean CBFv ( P<0.001 ) , whereas MABP and PaO2 were not . Conclusion : We observed prolonged increases of mean CBFv following suctioning in ventilated VLBW infants that were previously unrecognized . This is concerning since disturbances of CBF may be associated with subsequent brain injury Abstract A numeric scoring system for the assessment of hypoxic ischaemic encephalopathy during the neonatal period was tested . The value of the score in predicting neurodevelopmental outcome at 1 y of age was assessed . Forty‐five infants who developed hypoxic ischaemic encephalopathy after birth were studied prospect ively . In addition to the hypoxic ischaemic encephalopathy score all but two infants had at least one cranial ultrasound examination . Thirty‐five infants were evaluated at 12 months of age by full neurological examination and the Griffiths Scales of Mental Development . Five infants were assessed at an earlier stage , four who died before 6 months of age and one infant who was hospitalized at the time of the 12 month assessment . Twenty‐three ( 58 % ) of the infants were normal and 17 ( 42 % ) were abnormal , 16 with cerebral palsy and one with developmental delay . The hypoxic ischaemic encephalopathy score was highly predictive for outcome . The best correlation with outcome was the peak score ; a peak score of 15 or higher had a positive predictive value of 92 % and a negative predictive value of 82 % for abnormal outcome , with a sensitivity and specificity of 71 % and 96 % , respectively . For the clinician working in areas where sophisticated technology is unavailable this scoring system will be useful for assessment of infants with hypoxic ischaemic encephalopathy and for prognosis of neurodevelopmental outcome The effect of oro-naso-pharyngeal suction at birth on pulmonary mechanics is described in a r and om assigned controlled study of 40 normal term vaginally born infants . Twenty cases had their oro-naso-pharynx suctioned immediately after birth ( S Group ) , whereas 20 were not suctioned in the neonatal period ( NS Group ) . A computerized pneumotachographic system ( MECVENT ) was used for the assessment of respiratory mechanics ( Dynamic Compliance ( C. Dyn . ) and Total Pulmonary Resistance ( R ) in inspiration and expiration at 10 , 30 and 120 minutes after birth . In both groups the C. Dyn increased during the study period whereas the R decreased , mainly in the initial 30 minutes . No significant differences were observed between S and NS groups for any of the parameters of respiratory mechanics . The results obtained in this study provide no physiological basis to recommend routine airway suction at birth in normal , term , vaginally born infants Adverse changes in cerebral hemodynamics during endotracheal suctioning have been reported in conventionally ventilated newborns , whereas observations on the effect of endotracheal suctioning during high-frequency ventilation have not been reported to date . The present study was design ed to investigate the effect of endotracheal suctioning on cerebral hemodynamics in high-frequency and conventionally ventilated infants . Changes in cerebral concentration of oxygenated ( cO(2)Hb ) and deoxygenated hemoglobin ( cHHb ) and oxidized cytochrome aa3 ( cCyt.aa3 ) were measured by noninvasive near-infrared spectroscopy . In an open prospect i ve study , 26 suctioning periods in 9 high-frequency and in 6 conventionally ventilated newborn infants were investigated . Heart rate , arterial oxygen saturation ( SaO(2 ) ) , mean blood pressure ( MABP ) , and transcutaneous carbon dioxide tension ( TcpCO(2 ) ) were monitored continuously . In both groups , a marked decrease in heart rate , SaO(2 ) and in cO(2)Hb , an increase in cHHb , and a variable pattern in the concentration of total hemoglobin were noted during endotracheal suctioning . During suctioning , no statistically significant differences between the two methods of mechanical ventilation could be observed . We conclude that the mode of ventilation had no significant effect on changes in cerebral hemodynamics during endotracheal suctioning BACKGROUND Wiping of the mouth and nose at birth is an alternative method to oronasopharyngeal suction in delivery-room management of neonates , but whether these methods have equivalent effectiveness is unclear . METHODS For this r and omised equivalency trial , neonates delivered at 35 weeks ' gestation or later at the University of Alabama at Birmingham Hospital , Birmingham , AL , USA , between October , 2010 , and November , 2011 , were eligible . Before birth , neonates were r and omly assigned gentle wiping of the face , mouth ( implemented by the paediatric or obstetric resident ) , and nose with a towel ( wipe group ) or suction with a bulb syringe of the mouth and nostrils ( suction group ) . The primary outcome was the respiratory rate in the first 24 h after birth . We hypothesised that respiratory rates would differ by fewer than 4 breaths per min between groups . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT01197807 . FINDINGS 506 neonates born at a median of 39 weeks ' gestation ( IQR 38 - 40 ) were r and omised . Three parents withdrew consent and 15 non-vigorous neonates with meconium-stained amniotic fluid were excluded . Among the 488 treated neonates , the mean respiratory rates in the first 24 h were 51 ( SD 8) breaths per min in the wipe group and 50 ( 6 ) breaths per min in the suction group ( difference of means 1 breath per min , 95 % CI -2 to 0 , p<0·001 ) . INTERPRETATION Wiping the nose and mouth has equivalent efficacy to routine use of oronasopharyngeal suction in neonates born at or beyond 35 weeks ' gestation . FUNDING None OBJECTIVE To assess whether endotracheal suctioning of nonvigorous infants born through meconium stained amniotic fluid ( MSAF ) reduces the risk and complications of meconium aspiration syndrome ( MAS ) . STUDY DESIGN Term , nonvigorous babies born through MSAF were r and omized to endotracheal suction and no-suction groups ( n=61 in each ) . Risk of MAS , complications of MAS and endotracheal suction , mortality , duration of neonatal intensive care unit stay , and neurodevelopmental outcome at 9 months were assessed . RESULTS Maternal age , consistency of meconium , mode of delivery , birth weight , sex , and Apgar scores were similar in the groups . In total , 39 ( 32 % ) neonates developed MAS and 18 ( 14.8 % ) of them died . There were no significant differences in MAS , its severity and complications , mortality , and neurodevelopmental outcome for the 2 groups . One infant had a complication of endotracheal suctioning , which was mild and transient . CONCLUSIONS The current practice of routine endotracheal suctioning for nonvigorous neonates born through MSAF should be further evaluated . TRIAL REGISTRATION Clinical Trial Registry of India : CTRI/2013/03/003469 The purpose of the study was to examine the effects of bulb suctioning on healthy , term newborns and the feasibility of conducting a large-scale study of this practice . In a r and omized , controlled two-group design pilot study , 10 newborns received oronasopharyngeal bulb suctioning at birth and 10 did not . Differences in Apgar scores , heart rates , and oxygen saturation levels were determined . Infants were r and omized to groups before delivery . The participants were 20 term , healthy newborns of uncomplicated pregnancies . Apgar scores , heart rates , and oxygen saturation levels in the first 20 minutes of life were the main outcome variables . There were no statistically significant differences in Apgar scores between groups . Apgar scores at 5 and 10 minutes were 9 or 10 for all newborns . Newborns receiving bulb suctioning showed a statistically significant , lower heart rate ( P=.042 ) during the first 20 minutes and a significantly higher SpO2 level ( P=.005 ) by 15 minutes of age . Although statistically significant , these findings were not considered clinical ly significant because values remained within normal parameters BACKGROUND Meconium aspiration syndrome ( MAS ) is a life-threatening respiratory disorder in infants born through meconium-stained amniotic fluid ( MSAF ) . Although anecdotal data concerning the efficacy of intrapartum oropharyngeal and nasopharyngeal suctioning of MSAF are conflicting , the procedure is widely used . We aim ed to assess the effectiveness of intrapartum suctioning for the prevention of MAS . METHODS We design ed a r and omised controlled trial in 11 hospitals in Argentina and one in the USA . 2514 patients with MSAF of any consistency , gestational age at least 37 weeks , and cephalic presentation were r and omly assigned to suctioning of the oropharynx and nasopharynx ( including the hypopharynx ) before delivery of the shoulders ( n=1263 ) , or no suctioning before delivery ( n=1251 ) . Postnatal delivery-room management followed Neonatal Resuscitation Program guidelines . The primary outcome was incidence of MAS . Clinicians diagnosing the syndrome and design ating other study outcomes were masked to group assignment . An informed consent waiver was used . Analysis was by intention to treat . FINDINGS 18 infants in the suction group and 15 in the no suction group did not meet entry criteria after r and om assignment . 87 in the suction group were not suctioned , and 26 in the no suction group were suctioned . No significant difference between treatment groups was seen in the incidence of MAS ( 52 [ 4 % ] suction vs 47 [ 4 % ] no suction ; relative risk 0.9 , 95 % CI 0.6 - 1.3 ) , need for mechanical ventilation for MAS ( 24 [ 2 % ] vs 18 [ 1 % ] ; 0.8 , 0.4 - 1.4 ) , mortality ( 9 [ 1 % ] vs 4 [ 0.3 % ] ; 0.4 , 0.1 - 1.5 ) , or in the duration of ventilation , oxygen treatment , and hospital care . INTERPRETATION Routine intrapartum oropharyngeal and nasopharyngeal suctioning of term-gestation infants born through MSAF does not prevent MAS . Consideration should be given to revision of present recommendations Abstract Oronasopharyngeal suction ( ONPS ) with a suction bulb at birth is a traditional practice in the initial management of healthy infants in Iran and many other countries . The purpose of this study was to compare the effects of oronasopharyngeal suction ( ONPS ) with those of no suction in normal , term newborns delivered vaginally . A total of 170 healthy term infants of first and single uncomplicated pregnancies , with clear amniotic fluid , vaginal delivery and cephalic presentation , enrolled in the trial during labour . Newborns were r and omised into one of the two groups , according to the use of the ONPS procedure . Arterial oxygen saturation ( SaO2 ) levels , heart rates , blood gases of umbilical cord and Apgar scores were determined . The mean SaO2 values over the first and fifth min of
Output:
| The currently available evidence does not support or refute the benefits or harms of routine oro/nasopharyngeal suction over no suction . |
MS211896 | ***TASK*** the task is to summarize an input biomedical literature 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 objective is to assess the effect of mechanical and manual intermittent cervical traction on pain , use of analgesics and disability during the recent cervical radiculopathy ( CR ) . METHODS We made a prospect i ve r and omized study including patients sent for rehabilitation between April 2005 and October 2006 . Thirty-nine patients were divided into three groups of 13 patients each . A group ( A ) treated by conventional rehabilitation with manual traction , a group ( B ) treated with conventional rehabilitation with intermittent mechanical traction and a third group ( C ) treated with conventional rehabilitation alone . We evaluated cervical pain , radicular pain , disability and the use of analgesics at baseline , at the end and at 1 , 3 and 6 months after treatment . RESULTS At the end of treatment improving of cervical pain , radicular pain and disability is significantly better in groups A and B compared to group C. The decrease in consumption of analgesics is comparable in the three groups . At 6 months improving of cervical and radicular pain and disability is still significant compared to baseline in both groups A and B. The gain in consumption of analgesics is significant in the three groups : A , B and C. CONCLUSION Manual or mechanical cervical traction appears to be a major contribution in the rehabilitation of CR particularly if it is included in a multimodal approach of rehabilitation Background : To date , optimal strategies for the management of patients with cervical radiculopathy remain elusive . Preliminary evidence suggests that a multimodal treatment program consisting of manual therapy , exercise , and cervical traction may result in positive outcomes for patients with cervical radiculopathy . However , limited evidence exists to support the use of mechanical cervical traction in patients with cervical radiculopathy . Objective : The purpose of this study was to examine the effects of manual therapy and exercise , with or without the addition of cervical traction , on pain , function , and disability in patients with cervical radiculopathy . Design : This study was a multicenter r and omized clinical trial . Setting : The study was conducted in orthopedic physical therapy clinics . Patients : Patients diagnosed with cervical radiculopathy ( N=81 ) were r and omly assigned to 1 of 2 groups : a group that received manual therapy , exercise , and intermittent cervical traction ( MT EXTraction group ) and a group that received manual therapy , exercise , and sham intermittent cervical traction ( MTEX group ) . Intervention : Patients were treated , on average , 2 times per week for an average of 4.2 weeks . Measurements : Outcome measurements were collected at baseline and at 2 weeks and 4 weeks using the Numeric Pain Rating Scale ( NPRS ) , the Patient-Specific Functional Scale ( PSFS ) , and the Neck Disability Index ( NDI ) . Results : There were no significant differences between the groups for any of the primary or secondary outcome measures at 2 weeks or 4 weeks . The effect size between groups for each of the primary outcomes was small ( NDI=1.5 , 95 % confidence interval [CI]=−6.8 to 3.8 ; PSFS=0.29 , 95 % CI=−1.8 to 1.2 ; and NPRS=0.52 , 95 % CI=−1.8 to 1.2 ) . Limitations : The use of a nonvali date d clinical prediction rule to diagnose cervical radiculopathy and the lack of a control group without treatment were limitations of this study . Conclusions : The results suggest that the addition of mechanical cervical traction to a multimodal treatment program of manual therapy and exercise yields no significant additional benefit to pain , function , or disability in patients with cervical radiculopathy Ongoing efforts to develop mechanisms-based assessment and treatment of chronic pain have been hindered by the lack of assessment tools differentially sensitive to various phenomena underlying different mechanisms of pain . This study describes the development of an assessment instrument intended to measure neuropathic pain based on qualities of pain as they are inferred from pain descriptors . Subjects were 528 chronic pain patients from several clinics . Of these , 149 had strictly neuropathic pain , while 233 had non-neuropathic pain . Subjects completed a 32 item preliminary question naire , which asked them to rate their usual pain on multiple descriptors , as well as the degree to which their pain differed in response to various internal and external factors . This preliminary question naire was su bmi tted to factor analysis , and this yielded 6 factors . Representatives of each of these factors were combined with additional items that demonstrated significant differences between neuropathic and non-neuropathic pain groups , to yield a 12 item Neuropathic Pain Question naire ( NPQ ) . These items were able to differentiate neuropathic pain patients from non-neuropathic pain patients in a holdout sample with 66.6 % sensitivity and 74.4 % specificity . The newly developed instrument , NPQ , may be used for the initial screening of neuropathic pain patients . It also has the ability to provide a quantitative measure for the descriptors important in the diagnosis and assessment of neuropathic pain . Consequently , it can be used for monitoring of neuropathic pain treatments and as an outcome measure A new design of cervical traction modality with closed loop traction weight control based on electromyographic ( EMG ) biofeedback was developed . It consists of the development of a high signal-to-noise ratio EMG scanner , on-line self-adjusted traction weight controller , computer interface hardware , and closed loop biofeedback control software . Six healthy , young adults received conventional cervical traction to establish basic information of cervical EMG activities . Twenty-four patients with cervical radiculopathy were r and omly divided into two groups for clinical assessment by conventional and new EMG biofeedback traction modality . The average electromyographic activity in healthy subjects ranged from 2.41 to 3.49 microV , whereas EMG activity in patients with neck pain ranged from 4.75 to 6.97 microV. There was a significant decrease of EMG activity during the whole traction phase , especially at pull phase in healthy subjects , but it was not as significant in patients with cervical radiculopathy . There was no significant change of myoelectric activity in the paraspinal muscles at vertebral levels C1 - 2 , C3 - 4 , and C5 - 6 . Comparison of the average EMG activity of the paraspinal C-5 muscle in different phases of cervical traction showed a more significant decrease of EMG activity during the pull phase of traction as well as after traction in the high muscle tension group ( with EMG activity above 5 microV ) , especially with the biofeedback traction modality . The raised traction force from start to optimum was shortened from 4 to 2 wk to achieve the same effective outcome by biofeedback as conventional traction modality OBJECTIVE The objective of this study was to investigate the effect of the cervical traction modality with and without electromyographic ( EMG ) biofeedback for neck muscles in patients with cervical radiculopathy . METHODS This study was carried out at the Department of Rehabilitation Sciences , College of Applied Medical Sciences , King Saud University , Riyadh , Kingdom of Saudi Arabia between February and May 2002 . Twenty patients with cervical radiculopathy were r and omly divided into 2 equal groups . Group A was treated by a conventional traction modality and group B was treated by a conventional traction modality with EMG biofeedback ( to obtain relaxation of paraspinal neck muscles ) . The average EMG activity was recorded pre and post treatment at cervical ( C ) 5 - 6 level for both groups during pull , rest and post traction for a period of 6 weeks . RESULTS Comparison of the average EMG activity of the paraspinal C5 - 6 muscle in different phases of cervical traction showed significant decrease of EMG activity during the pull phases of traction as well as after traction , especially with group B which was treated by the EMG biofeedback modality . CONCLUSION Electromyographic biofeedback with cervical traction showed a significant effect in avoiding muscle spasm and decreasing root compression during traction Objective : To determine if combining intermittent cervical traction with conventional physical therapy methods is more effective than using conventional approaches alone in the improvement of the grip strength and treatment of the patients with unilateral cervical 7 ( C7 ) radiculopathy . Design : R and omized controlled trial ( RCT ) . Setting : An outpatient physical therapy clinic , University of Social Welfare and Rehabilitation Science , Iran . Patients : A sample of convenience of 30 patients with unilateral C7 radiculopathy participated in this study . Patients were assigned r and omly to a control ( N=15 , mean age=46.939 ±5.32 ) and an experimental group ( N=15 , mean age=47.53 ±5.6 ) . Interventions : Electrotherapyu/exercise treatment for control group and combined cervical traction and electrotherapyu/exercise for experimental group . Ten physical therapy sessions , three times a week for each group . Main outcome measures : Grip strength as an appropriate objective parameter was measured before treatment and after 5 and 10 treatment sessions . Results : Statistical analysis ( paired t-test ) revealed significant increase in grip strength after 10 treatment sessions in control ( p<0.01 ) and experimental group ( p<0.01 ) compared with pretreatment score . In the ANCOVA , controlling for pretest scores , no significant difference was found between the two groups in the after 10 treatment sessions grip score ( p=0.65 ) . However , the change in grip strength after five sessions was significantly greater for the experimental group than for the control group ( P=0.04 ) . Conclusions : The application of cervical traction combined with electrotherapy and exercise produced an immediate improvement in the h and grip function in patients with cervical radiculopathy Previous investigations with plain radiography , myelography , and computed tomography have shown that degenerative disease of the cervical spine frequently occurs in the absence of clinical symptoms . We studied the magnetic resonance-imaging scans of sixty-three volunteers who had no history of symptoms indicative of cervical disease . The scans were mixed r and omly with thirty-seven scans of patients who had a symptomatic lesion of the cervical spine , and all of the scans were interpreted independently by three neuroradiologists . The scans were interpreted as demonstrating an abnormality in 19 per cent of the asymptomatic subjects : 14 per cent of those who were less than forty years old and 28 per cent of those who were older than forty . Of the subjects who were less than forty , 10 per cent had a herniated nucleus pulposus and 4 per cent had foraminal stenosis . Of the subjects who were older than forty , 5 per cent had a herniated nucleus pulposus ; 3 per cent , bulging of the disc ; and 20 per cent , foraminal stenosis . Narrowing of a disc space , degeneration of a disc , spurs , or compression of the cord were also recorded . The disc was degenerated or narrowed at one level or more in 25 per cent of the subjects who were less than forty years old and in almost 60 per cent of those who were older than forty . The prevalence of abnormal magnetic-resonance images of the cervical spine as related to age in asymptomatic individuals emphasizes the dangers of predicating operative decisions on diagnostic tests without precisely matching those findings with clinical signs and symptoms PURPOSE To describe and explore the relationships between pain , emotional state and coping strategies in patients with chronic radicular neck pain before and after surgery or conservative treatments . METHODS We r and omize 81 conseutive patients with cervical radicular pain and nerve root compression , verified by MRI , to either surgical decompression with fusion or physiotherapy or neck collar . Emotional state was both measured with Mood Adjective Check List . Hospital Anxiety and Depression Scale and with a Coping Strategies Question naire . Pain was measured with VAS and function with Disability Index Rating . Measurements were made before treatment , and follow ups after 3 and 12 months post treatment . RESULTS We found generally a low emotional state with anxiety , depression and sleep-disturbances not only connected to pain . Pain improved faster in the surgery group but after one year no differences were seen . Surgery and physiotherapy improved function with heavy work compared to collar after 3 months . Many patients used active coping before treatment , but after treatment more passive coping strategies were found . CONCLUSION We recommend a multidisciplinary rehabilitation with cognitive behavioural therapy and psychological interventions This prospect i ve , r and omised study compares the efficacy of surgery , physiotherapy and cervical collar with respect to pain , motor weakness and sensory loss in 81 patients with long-lasting cervical radiculopathy corresponding to a nerve root that was significantly compressed by spondylotic encroachment , with or without an additional bulging disk , as verified by MRI or CT-myelography . Pain intensity was registered on a visual analogue scale ( VAS ) , muscle strength was measured by a h and -held dynamometer , Vigorometer and pinchometer . Sensory loss and paraesthesia were recorded . The measurements were performed before treatment ( control 1 ) , 4 months after the start of treatment ( control 2 ) and after a further 12 months ( control 3 ) . A healthy control group was used for comparison and to test the reliability of the muscle-strength measurements . The study found that before start of treatment the groups were uniform with respect to pain , motor weakness and sensory loss . At control 2 the surgery group reported less pain , less sensory loss and had better muscle strength , measured as the ratio of the affected side to the non-affected side , compared to the two conservative treatment groups . After a further year ( control 3 ) , there were no differences in pain intensity , sensory loss or paraesthesia between the groups . An improvement in muscle strengths , measured as the ratio of the affected to the non-affected side , was seen in the surg
Output:
| There is consensus on the presence of pain , but not on the exact location of pain |
MS211897 | ***TASK*** the task is to summarize an input biomedical literature 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 define outcome data and prognostic criteria for patients with metastatic renal cell carcinoma ( RCC ) treated with interferon-alfa as initial systemic therapy . The data can be applied to design and interpretation of clinical trials of new agents and treatment programs against this refractory malignancy . PATIENTS AND METHODS Four hundred sixty-three patients with advanced RCC administered interferon-alpha as first-line systemic therapy on six prospect i ve clinical trials were the subjects of this retrospective analysis . Three risk categories for predicting survival were identified on the basis of five pretreatment clinical features by a stratified Cox proportional hazards model . RESULTS The median overall survival time was 13 months . The median time to progression was 4.7 months . Five variables were used as risk factors for short survival : low Karnofsky performance status , high lactate dehydrogenase , low serum hemoglobin , high corrected serum calcium , and time from initial RCC diagnosis to start of interferon-alpha therapy of less than one year . Each patient was assigned to one of three risk groups : those with zero risk factors ( favorable risk ) , those with one or two ( intermediate risk ) , and those with three or more ( poor risk ) . The median time to death of patients deemed favorable risk was 30 months . Median survival time in the intermediate-risk group was 14 months . In contrast , the poor-risk group had a median survival time of 5 months . CONCLUSION Progression-free and overall survival with interferon-alpha treatment can be compared with new therapies in phase II and III clinical investigations . The prognostic model is suitable for risk stratification of phase III trials using interferon-alpha as the comparative treatment arm Objective : To report side effects seen in a clinical cohort of patients aged > 65 years with rheumatoid arthritis ( RA ) treated with the tumor necrosis factor-α TNF-α blocker etanercept and to compare the side effects rate with patients aged ≤65 years . Methods : All patients with RA that started etanercept and who were referred to our rheumatology unit from November 2005 to March 2009 were included in this study and prospect ively followed to collect side effects related to therapy . Results : One hundred three patients were enrolled : 41 ( 37 females , 4 males ) aged > 65 years and 62 ( 40 females , 22 males ) aged < 65 years . In the patients aged > 65 years , the safety profile ( defined as rate of side effects ) of etanercept was similar to that in patients aged ≤65 years ( P > 0.05 ) and the survival curves between the groups were similar ( P > 0.05 ) . Conclusions : In our three-year experience , the anti-TNFα agent etanercept has been well tolerated and safe in elderly patients . The risk of side effects in these patients was no greater than in subjects aged ≤65 years . However , such inhibitors are associated with various and numerous side effects and elderly patients with RA should be carefully monitored to limit the risk of side effects during anti-TNFα therapy as much as possible Background The perception that older cancer patients may be at higher risk than younger patients of toxic effects from cancer therapy but may obtain less clinical benefit from it may be based on the underrepresentation of older patients in clinical trials and the known toxic effects of cytotoxic chemotherapy . It is not known how older patients respond to targeted therapy . Methods This retrospective subgroup analysis of data from the phase 3 , r and omized Treatment Approach in Renal Cancer Global Evaluation Trial examined the safety and efficacy of sorafenib in older ( age ≥70 years , n = 115 ) and younger patients ( age < 70 years , n = 787 ) who received treatment for advanced renal cell carcinoma . Patient demographics and progression-free survival were recorded . Best tumor response , clinical benefit rate ( defined as complete response plus partial response plus stable disease ) , time to self-reported health status deterioration , and toxic effects were assessed by descriptive statistics . Health-related quality of life was assessed with a Cox proportional hazards model . Kaplan – Meier analyses were used to summarize time-to-event data . Results Median progression-free survival was similar in sorafenib-treated younger patients ( 23.9 weeks ; hazard ratio [ HR ] for progression compared with placebo = 0.55 , 95 % confidence interval [ CI ] = 0.47 to 0.66 ) and older patients ( 26.3 weeks ; HR = 0.43 , 95 % CI = 0.26 to 0.69 ) . Clinical benefit rates among younger and older sorafenib-treated patients were also similar ( 83.5 % and 84.3 % , respectively ) and were superior to those of younger and older placebo-treated patients ( 53.8 % and 62.2 % , respectively ) . Adverse events were predictable and manageable regardless of age . Sorafenib treatment delayed the time to self-reported health status deterioration among both older patients ( 121 days with sorafenib vs 85 days with placebo ; HR = 0.66 , 95 % CI = 0.43 to 1.03 ) and younger patients ( 90 days with sorafenib vs 52 days with placebo ; HR = 0.69 , 95 % CI = 0.59 to 0.81 ) and improved quality of life over that time . Conclusions Among patients with advanced renal cell carcinoma receiving sorafenib treatment , outcomes of older ( ≥70 years ) and younger ( < 70 years ) patients were similar Background The development of novel chemotherapeutic agents in colorectal cancer has improved survival . Following initial response to chemotherapeutic strategies many patients develop refractory disease . This poses a significant challenge common to many cancer subtypes . Newer agents such as Bevacizumab have successfully targeted the tyrosine kinase receptor epidermal growth factor receptor in metastatic colorectal cancer . Human epidermal growth factor receptor-2 is another member of the tyrosine kinase receptor family which has been successfully targeted in breast cancer . This may play a role in colorectal cancer . We conducted a clinicopathological study to determine if overexpression of human epidermal growth factor receptor-2 is a predictor of outcome in a cohort of patients with colorectal cancer . Methods Clinicopathological data and paraffin-embedded specimens were collected on 132 consecutive patients who underwent colorectal resections over a 24-month period at Mayo General Hospital . Twenty-six contained non-malignant disease . Her-2/neu protein overexpression was detected using immunohistochemistry ( IHC ) . The HER-2 4B5 Ventana monoclonal antibody was used . Fluorescent insitu hybridisation ( FISH ) was performed using INFORM HER-2/Neu Plus . Results were correlated with established clinical and pathological predictors of outcome including TNM stage . Statistical analysis was performed using SPSS version 11.5 . Results 114 were HER-2/Neu negative using IHC , 7 showed barely perceptible positivity ( 1 + ) , 9 showed moderate staining ( 2 + ) and 2 were strongly positive ( 3 + ) . There was no correlation with gender , age , grade , Dukes ' stage , TNM stage , time to recurrence and 5-year survival ( p > 0.05 ) . FISH was applied to all 2 + and 3 + cases as well as some negative cases selected at r and om . Three were amplified ( 2 were 3 + and 1 was 2 + ) . Similarly , HER-2 gene overexpression did not correlate with established prognostic indicators . Conclusion HER-2 protein is over expressed in 11 % of colorectal cancer patients . The gene encoding HER-2 is amplified in 3 % of cases . Overexpression of HER-2 is not a predictor of outcome . However , patients who over express HER-2 may respond to Herceptin therapy LBA4 Background : Temsirolimus ( TEMSR , CCI-779 ) is a specific inhibitor of mTOR , a signaling protein that regulates cell growth and angiogenesis . In a single-agent , phase 2 study , TEMSR administration to heavily pretreated patients ( pts , n = 111 ) with adv RCC result ed in a median overall survival ( OS ) of 15.0 mos ( Atkins et al , J Clin Oncol 2004 ) . Retrospectively , 49 pts were categorized in a poor-risk group ( Motzer et al , J Clin Oncol 2002 ) . The TEMSR-treated pts in this group had a 1.7-fold longer median OS than the first-line , IFN-treated , poor-risk group reported by Motzer et al. In a phase 1 study , the maximum tolerated dose of the combination of TEMSR + IFN in adv RCC pts was TEMSR 15 mg intravenously ( IV ) once/wk + IFN 6 million units ( MU ) subcutaneously ( SC ) 3 times weekly ( TIW ) ( Smith et al , Proc ASCO 2004 ) . Thus , this phase 3 study in first-line , poor-risk adv RCC pts was initiated in July 2003 . METHODS Pts with adv RCC and no prior systemic therapy were enrolled in this open-label study if they had ≥3 of 6 risk factors ( the 5 Motzer criteria and > 1 metastatic disease site ) . Pts were r and omized ( 1:1:1 ) to arm 1 , IFN up to 18 MU SC TIW ; arm 2 , TEMSR 25 mg IV once/wk ; or arm 3 , TEMSR 15 mg IV once/wk + IFN 6 MU SC TIW . The primary study endpoint was OS ; the study was powered to compare the TEMSR arms with the IFN arm . RESULTS We report 20 Mar 2006 preliminary data from an interim analysis performed by the IDMC . Of the 626 pts enrolled , 442 deaths occurred . Patients treated with TEMSR had a statistically longer survival than those treated with IFN ( Table ) . OS of patients treated with IFN and TEMSR + IFN were not statistically different . The 3 most frequently occurring adverse events ≥gr 3 were asthenia ( arm 1 : arm 2 : arm 3 , 27 % : 12 % : 30 % pts ) , anemia ( 24 % : 21 % : 39 % pts ) , and dyspnea ( 8 % : 9 % : 11 % pts ) . CONCLUSIONS Single-agent TEMSR significantly increases the OS of first-line , poor-risk adv RCC pts compared with IFN , with an acceptable safety profile . [ Table : see text ] [ Table : see text ] Sir , We thank you for providing us the opportunity to respond to the Letter to the Editor received by your office in response to our article ‘ Sunitinib and bevacizumab for first-line treatment of metastatic renal cell carcinoma : a systematic review and indirect comparison of clinical effectiveness ' ( Thompson Coon et al , 2009 ) . We are pleased that Professor Mickisch recognises the need for and importance of indirect treatment comparisons in the absence of head-to-head comparisons and welcome a debate on the relative merits of indirect treatment comparison methods . It appears that some of the comments outlined by Professor Mickisch stem from a misunderst and ing of the methods used in our analysis . Ideally we would have given a more detailed account in the paper , but owing to restrictions in the length of the article we chose to rely on the cited reference ( Ades , 2003 ) to provide a fuller description of the methods used . Our analysis was mainly conducted within the Bayesian framework and as such issues relating to frequentist hypothesis testing are not applicable . Our analysis compared the reported differences ( hazard ratios ) between the three treatments rather than comparing the absolute effects of sunitinib with those of bevacizumab plus IFN and those of IFN alone . Accordingly , it is important to clarify that we did not use a one-sided t-test to calculate the P-value , as inferred by Professor Mickisch . We acknowledge that the language used in describing the output from the MCMC as a one-sided P-value may give rise to some interpretation issues for an audience who are more familiar with frequentist hypothesis testing than Bayesian analysis . The P-value obtained from the MCMC – although regarded as equivalent to that obtained from a one-sided test – is in reality a direct estimate of the probability that one treatment is better than another . It is one of the advantages of the Bayesian approach that it enables intuitive probability statements to be made about propositions ; in this case , 0.0272 is an estimate of the probability that bevacizumab provides superior PFS gain to sunitinib . As a result , within the context of our analysis , it would have been neither possible nor desirable to adopt the methods suggested by Professor Mickisch , which relate solely to the frequentist paradigm . In terms of the number of simulations used in our analysis , we are unaware of any references suggesting that simulation numbers should be as low as 2000 iterations in an MCMC and we would be interested in the source of Professor Mickisch 's comments . It is important to clarify that we were not simulating individual patient experiences but rather repeatedly sampling the differences between treatments in each of the uncertain distributions ( i.e. , our analysis was at the level of a cohort of patients as reflected in trial results ) . Accordingly , caution s that apply to , for example , bootstrap sampling of individual patient data are not applicable in this instance . Increasing the number of simulations in an MCMC will produce a more accurate estimate ( with less possibility of the outputs being distorted by outlying or extreme simulations ) , but will not result in spurious certainty ( in other words , the posterior distribution will become smoother , but not narrower ) . Notwithst and ing the relevance of guidance from the Canadian Agency for Drugs and Technologies in Health ( CADTH ) to this work , we do not share Professor Mickisch
Output:
| In patients with clear cell renal cancers who had failed prior cytokine therapy , oral sorafenib gives a better quality of life than placebo as well as improved chance of being free of disease progression ; overall survival may have improved but is hard to evaluate because of crossover of placebo-assigned patients after the study closed to accrual ( Escudier 2007a ) .
Based on less than a decade of experience , some targeted agents with specified molecular targets have demonstrated clinical ly useful benefits over the previous st and ard of care for patients with advanced renal cancer . |
MS211898 | ***TASK*** the task is to summarize an input biomedical literature 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 Recent studies suggest that strict perioperative glycemic control improves clinical outcomes after cardiothoracic surgery . However , optimal methods and targets for controlling blood glucose ( BG ) levels in this setting have not been established . Currently published intensive insulin infusion protocol s ( IIPs ) have important practical limitations , which may affect their utility . In this article , the authors present their experience with a safe , effective , nurse-driven IIP , which was implemented simultaneously in 2 cardiothoracic intensive care units ( CTICUs ) . DESIGN Prospect i ve cohort study . SETTING Tertiary referral hospital and community teaching hospital . PARTICIPANTS CTICU patients . INTERVENTIONS A st and ardized , intensive IIP was used for all patients admitted to both CTICUs . Hourly BG levels , relevant baseline variables , and clinical interventions were collected prospect ively from the active hospital chart and CTICU nursing records . MEASUREMENTS AND MAIN RESULTS The IIP was used 137 times in 118 patients . The median time required to reach target BG levels ( 100 - 139 mg/dL ) was 5 hours . Once BG levels decreased below 140 mg/dL , 58 % of 2,242 subsequent hourly BG values fell within the narrow target range , 73 % within a " clinical ly desirable " range of 80 to 139 mg/dL , and 94 % within a " clinical ly acceptable " range of 80 to 199 mg/dL. Only 5 ( 0.2 % ) BG values were less than 60 mg/dL , with no associated adverse clinical events . CONCLUSIONS The IIP safely and effectively improved glycemic control in 2 CTICUs , with minimal hypoglycemia . Based on prior studies showing the benefits of strict glycemic control , the implementation of this IIP should help to reduce morbidity and mortality in CTICU patients Background —This study sought to determine whether tight glycemic control with a modified glucose-insulin-potassium ( GIK ) solution in diabetic coronary artery bypass graft ( CABG ) patients would improve perioperative outcomes . Methods and Results —One hundred forty-one diabetic patients undergoing CABG were prospect ively r and omized to tight glycemic control ( serum glucose , 125 to 200 mg/dL ) with GIK or st and ard therapy ( serum glucose < 250 mg/dL ) using intermittent subcutaneous insulin beginning before anesthesia and continuing for 12 hours after surgery . GIK patients had lower serum glucose levels ( 138±4 versus 260±6 mg/dL ; P < 0.0001 ) , a lower incidence of atrial fibrillation ( 16.6 % versus 42 % ; P = 0.0017 ) , and a shorter postoperative length of stay ( 6.5±0.1 versus 9.2±0.3 days ; P = 0.003 ) . GIK patients also showed a survival advantage over the initial 2 years after surgery ( P = 0.04 ) and decreased episodes of recurrent ischemia ( 5 % versus 19 % ; P = 0.01 ) and developed fewer recurrent wound infections ( 1 % versus 10 % , P = 0.03 ) . Conclusions —Tight glycemic control with GIK in diabetic CABG patients improves perioperative outcomes , enhances survival , and decreases the incidence of ischemic events and wound complications BACKGROUND AND PURPOSE Hyperglycemia following acute stroke is strongly associated with subsequent mortality and impaired neurological recovery , but it is unknown whether maintenance of euglycemia in the acute phase improves prognosis . Furthermore , the safety of such intervention is not established . METHODS In an explanatory , r and omized , controlled trial to test safety , 53 acute ( within 24 hours of ictus ) stroke patients with mild to moderate hyperglycemia ( plasma glucose between 7.0 and 17.0 mmol/L ) were r and omized to receive either a 24-hour infusion of 0.9 % ( 154 mmol/L ) saline or a glucose potassium insulin ( GKI ) infusion at 100 mL/h . The GKI consisted of 16 U human soluble insulin and 20 mmol potassium chloride in 500 mL 10 % glucose . Blood glucose was measured every 2 hours with Boehringer Mannheim Glycaemie test strips , pulse and blood pressure were measured every 4 hours , and plasma glucose sample s were taken every 8 hours . Insulin concentration in the GKI was altered according to BM glucose values . RESULTS There were no statistically significant differences between the 2 groups at baseline . Twenty-five patients received GKI , 1 of whom required intravenous glucose for symptomatic hypoglycemia . Plasma glucose levels were nonsignificantly lower in the GKI group throughout the infusion period . Four-week mortality in the GKI group was 7 ( 28 % ) , compared with 8 ( 32 % ) in the control group . CONCLUSIONS GKI infusions can be safely administered to acute stroke patients with mild to moderate hyperglycemia producing a physiological but attenuated glucose response to acute stroke , the effectiveness of which remains to be eluci date BACKGROUND : Critically ill cardiothoracic patients are prone to hyperglycemia and an increased risk of surgical site infections postoperatively . Aggressive insulin treatment is required to achieve tight glycemic control ( TGC ) and improve outcomes . OBJECTIVE : To examine and report on the performance of an insulin infusion protocol to maintain TGC , defined as a blood glucose level of 80–150 mg/dL , in critically ill cardiothoracic surgical patients . METHODS : A nurse-driven insulin infusion protocol was developed and initiated in postoperative cardiothoracic surgical intensive care patients with or without diabetes . In this before — after cohort study , 2 periods of measurement were performed : a 6–month baseline period prior to the initiation of the insulin infusion protocol ( control group , n = 174 ) followed by a 6–month intervention period in which the protocol was used ( TGC group , n = 168 ) . RESULTS : Findings showed percent and time of blood glucose measurements within the TGC range ( control 47 % vs TGC 61 % ; p = 0.001 ) , AUC of glucose exposure > 150 mg/dL versus time for the first 24 hours of the insulin infusion ( control 28.4 vs TGC 14.8 ; p < 0.001 ) , median time to blood glucose < 150 mg/dL ( control 9.4 h vs TGC 2.1 h ; p < 0.001 ) , and percent blood glucose < 65 mg/dL as a marker for hypoglycemia ( control 9.8 % vs TGC 16.7 % ; NS ) . CONCLUSIONS : An insulin infusion protocol design ed to achieve a goal blood glucose range of 80–150 mg/dL efficiently and significantly improved TGC in critically ill postoperative cardiothoracic surgery patients without significantly increasing the incidence of hypoglycemia Intensive insulin therapy to control blood glucose has been found to reduce mortality among critically ill patients in a surgical intensive care unit , though a simple prescriptive insulin infusion protocol to achieve this has not been published previously . This study documents the development and routine use of a simple prescriptive intravenous insulin infusion protocol for critically ill patients and compares the results with previous practice . During development the protocol was optimized and practical issues of implementation addressed . The optimized protocol was then used for all ICU admissions , and a prospect ively defined retrospective chart audit performed for the first month of use . Results were compared with a similar time period the previous year . In September 2002 , 27 admissions were started on the protocol . Blood glucose for the time on the protocol had a median value of 6.2 ( IQR 5.9 - 7.1 ) mmol/l compared with 9.2 ( IQR 8.1 - 10.2 ) mmol/l for those on insulin in 2001 . Blood glucose for the whole ICU stay for those on the protocol in 2002 had a median value of 6.6 ( IQR 6.0 - 7.4 ) mmol/l compared with 8.6 ( IQR 8.0 - 9.4 ) mmol/l in 2001 . Blood glucose for all ICU patients in 2002 had a median value of 6.5 ( IQR 6.0 - 7.3 ) mmol/l compared with 7.2 ( IQR 6.3 - 8.3 ) mmol/l in 2001 . Three blood glucose recordings were less than 2.2 mmol/l in September 2002 . This study provides initial effectiveness and safety data for the Bath Insulin Protocol . Further audits in a larger patient population are now needed OBJECTIVE To describe the main findings of the Portl and Diabetic Project , which eluci date s the adverse relationship between hyperglycemia and outcomes of cardiac surgical procedures in patients with diabetes and delineates the protective effects of intravenous insulin therapy in reducing those adverse outcomes . RESULTS In this ongoing 17-year prospect i ve , nonr and omized , interventional study of 4,864 patients with diabetes who underwent an open-heart surgical procedure , we investigated the effects of hyperglycemia , and its subsequent reduction by continuous intravenous insulin ( CII ) therapy , on in-hospital outcomes . Increasing blood glucose levels were found to be directly associated with increasing rates of death , deep sternal wound infections ( DSWI ) , length of hospital stay ( LOS ) , and hospital cost . In separate multivariate analyses , increasing hyperglycemia was found to be independently predictive of increasing mortality ( P<0.0001 ) , DSWI ( P = 0.017 ) , and LOS ( P<0.002 ) . Conversely , CII therapy , design ed to achieve predetermined target blood glucose levels , independently reduced the risks of death and DSWI by 57 % and 66 % , respectively ( P<0.0001 for both ) . Target blood glucose levels of less than 150 mg/dL and a 3-day postoperative duration of CII therapy are both important variables that determine the effect of the CII therapy on improved outcomes . Coronary artery bypass grafting-related mortality ( 2.5 % ) and DSWI rates ( 0.8 % ) in patients with diabetes were normalized to those of the nondiabetic population by the use of the Portl and CII Protocol . CONCLUSION Perioperative hyperglycemia in patients undergoing a cardiac surgical procedure affects biochemical and physiologic functions , which , in turn , adversely alter mortality , LOS , and infection rates . The Portl and CII Protocol is a cost-efficient method that effectively eliminates hyperglycemia and reduces postoperative morbidity and mortality in patients with diabetes undergoing an open-heart operation . CII protocol s should be the st and ard care for glycometabolic control in all patients undergoing cardiac surgical procedures OBJECTIVES This study tested the impact of intensive metabolic treatment with insulin on transient myocardial ischaemia detected with continuous 12-lead ST-segment monitoring during non-ST segment elevation acute coronary syndromes in type 2 diabetic patients . METHODS AND RESULTS The study included 57 type 2 diabetic patients with non-ST segment elevation acute coronary syndromes . Twenty-eight patients r and omized to conventional treatment plus intensive insulin therapy ( group A ) and twenty-nine to conventional therapy only ( group B ) . Group A patients received insulin by infusion for 48 hours according to a predefined protocol aim ing to maintain normoglycaemia . Group B patients received st and ard coronary care unit treatment . The ST-segment monitoring was performed for 48 hours in the coronary care unit . The two groups were comparable in terms of medical history , clinical and biochemical data . Three patients from both groups were excluded from the analysis because there was objective evidence for evolution in persistent ST-segment elevation acute myocardial infa rct ion . Six patients ( 24 % ) from group A vs. twelve from group B ( 46.2 % ) had evidence of transient ischaemia ( p = 0.098 ) . Group A patients showed significantly lower values in the mean number [ group A vs. group B : 0.4 + /- 0.8 vs. 2 + /- 3.1 , p < 0.01 ] and total duration of ST-episodes [ group A vs. group B : 2.4 + /- 5.1 vs. 21.2 + /- 31 min , p < 0.01 ] . Multivariate analysis revealed that the mean plasma glucose during the study period was a powerful predictor of the presence ( b:0.377,p < 0.01 ) , the number ( b:0.523,p < 0.001 ) and the total duration ( b : 0.686 , p < 0.001 ) of ST-episodes , respectively . CONCLUSIONS ; Intensive insulin treatment considerably decreases the number and the total duration of ST-episodes in type 2
Output:
| ConclusionS tudies using a dynamic scale protocol combining a tight glucose target and the last two blood glucose values to determine the insulin infusion rate yielded the best results in terms of glycaemic control and reported low frequencies of hypoglycaemic episodes |
MS211899 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Recent consensus guidelines recommend pregabalin as a first-tier treatment for painful diabetic peripheral neuropathy ( DPN ) . We evaluated the efficacy of pregabalin 600 mg/d ( 300 mg dosed BID ) versus placebo for relieving DPN-associated neuropathic pain , and assessed its safety using objective measures of nerve conduction ( NC ) . Methods In this r and omized , double-blind , placebo-controlled trial , the primary efficacy measure was endpoint mean pain score ( MPS ) from daily pain diaries ( 11-point scale ) . NC velocity and sensory and motor amplitudes were assessed at baseline , endpoint , and end of follow-up ( 2 weeks post-treatment ) . At each timepoint , the median-motor , median-sensory , ulnar-sensory , and peroneal-motor nerves were evaluated . Secondary efficacy measures included weekly MPS and proportion of responders ( patients achieving ≥50 % reduction in MPS from baseline to endpoint ) . After 1-weeks ' dosage escalation , pregabalin-treated patients received 300 mg BID for 12 weeks . Results Eighty-two patients received pregabalin and 85 placebo . Mean duration s were 10 years for diabetes and ~5 years for painful DPN . Pregabalin-treated patients had lower MPS than controls ( mean difference , -1.28 ; p < .001 ) . For all four nerves , 95 % CIs for median differences in amplitude and velocity from baseline to endpoint and baseline to follow-up included 0 ( ie , no significant difference vs. placebo ) . Significant pain improvement among pregabalin-treated patients was evident at week 1 and sustained at every weekly timepoint . More pregabalin-treated patients ( 49 % ) than controls ( 23 % ) were responders ( p < .001 ) . Conclusion Pregabalin 600 mg/d ( 300 mg BID ) effectively reduced pain , was well tolerated , and had no statistically significant or clinical ly meaningful effect on NC in patients with painful DPN.Trial registration Clinical Trials.gov & NA ; Post‐herpetic neuralgia ( PHN ) is a common and often intractable neuropathic pain syndrome predominantly affecting the elderly . Topical local anesthetics have shown promise in both uncontrolled and controlled studies . Thirty‐five subjects with established PHN affecting the torso or extremities completed a four‐session , r and om order , double‐blind , vehicle‐controlled study of the analgesic effects of topically applied 5 % lidocaine in the form of a non‐woven polyethylene adhesive patch . All subjects had allodynia on examination . Up to 3 patches , covering a maximum of 420 cm2 , were applied to cover the area of greatest pain as fully as possible . Lidocaine containing patches were applied in two of the four 12‐h‐long sessions , in one session vehicle patches were applied , and one session was a no‐treatment observation session . Lidocaine containing patches significantly reduced pain intensity at all time points 30 min to 12 h compared to no‐treatment observation , and at all time points 4–12 h compared to vehicle patches . Lidocaine patches were superior to both no‐treatment observation and vehicle patches in averaged category pain relief scores . The highest blood Lidocaine level measured was 0.1 & mgr;g/ ml , indicating minimal systemic absorption of Lidocaine . Patch application was without systemic side effects and well tolerated when applied on allodynic skin for 12 h. This study demonstrates that topical 5 % Lidocaine in patch form is easy to use and relieves post‐herpetic neuralgia An 8-week double-blind , multicenter , parallel study compared the safety and efficacy of topical capsaicin and oral amitriptyline in patients with painful diabetic neuropathy involving the feet . Two hundred thirty-five patients were r and omized to treatment with either capsaicin cream or amitriptyline capsules . Capsaicin-treated patients received inactive capsules , and amitriptyline-treated patients applied vehicle cream . A visual analogue scale of pain intensity and measurements of interference by pain with functional activities were recorded at onset and at 2-week intervals . A visual analogue scale of pain relief and physicians ' global evaluation assessed changes in pain status from baseline . Topical capsaicin and oral amitriptyline produced equal and statistically significant improvements in pain over the course of the study . By the end of week 8 , 76 % of patients in each group experienced less pain , with a mean reduction in intensity of more than 40 % . By the end of the study , the interference with daily activities by pain had diminished significantly ( P = .001 ) in both groups , including improvements in sleeping and walking . No systemic side effects were observed in patients treated with topical capsaicin . Most patients receiving amitriptyline experienced at least one systemic side effect , ranging from somnolence ( 46 % ) to neuromuscular ( 23 % ) and cardiovascular ( 9 % ) adverse effects . Topically applied capsaicin is an equally effective but considerably safer alternative to amitriptyline for relief of the pain of diabetic neuropathy An 8-week , double-blind , vehicle-controlled study was conducted to determine the effectiveness of topical capsaicin 0.075 % cream in relieving pain associated with diabetic neuropathy . Patients were selected who experienced moderate to very severe pain , which interfered with sleep or activities on a daily basis , and who were unresponsive or intolerant to conventional therapy . The results after 8 weeks showed a statistically significant difference in favor of the capsaicin-treated patients , with 90 % of these patients improved . The results of this study indicate that topical capsaicin 0.075 % cream is safe and effective in managing painful diabetic neuropathy The objective of this study was to compare the efficacy and tolerability of gabapentin and amitriptyline monotherapy in painful diabetic neuropathy . This was a 12-week , open-label , prospect i ve , r and omized trial . Twenty-five type-II diabetic patients with pain attributed to diabetic neuropathy and a minimum score of 2 on a pain intensity scale ranging from 0 ( no pain ) to 4 ( excruciating pain ) were r and omized to receive either gabapentin , titrated from 1,200 mg/day to a maximum of 2,400 mg/day , or amitriptyline , titrated from 30 mg/day to a maximum of 90 mg/day . Both drugs were titrated over a 4-week period and maintained at the maximum tolerated dose for 8 weeks . The main outcome measures were weekly pain intensity and paresthesia intensity , measured on two categorical scales . Thirteen patients received gabapentin and 12 received amitriptyline . All 25 patients completed the trial . Gabapentin produced greater pain reductions than amitriptyline ( mean final scores were 1.9 vs. 1.3 points below baseline scores ; P = 0.026 ) . Decreases in paresthesia scores also were in favor of gabapentin ( 1.8 vs. 0.9 points ; P = 0 . 004 ) . Adverse events were more frequent in the amitriptyline group than in the gabapentin group : they were reported by 11/12 ( 92 % ) and 4/13 ( 31 % ) of patients , respectively ( P = 0.003 ) . Side effects were the main limiting factor preventing dose escalation . Gabapentin produced greater improvements than amitriptyline in pain and paresthesia associated with diabetic neuropathy . Additionally , gabapentin was better tolerated than amitriptyline . Further controlled trials are needed to confirm these preliminary results Postherpetic neuralgia ( PHN ) following herpes zoster is a common and disabling neuropathic pain syndrome . In a double‐blind , three‐session study , 5 % lidocaine gel or vehicle was applied simultaneously to both the area of pain and to the contralateral mirror‐image unaffected skin . In the local session , lidocaine gel was applied to the painful skin area . In the remote session , lidocaine gel was applied to mirror‐image skin . In the placebo session , vehicle was applied bilaterally . For cranial PHN , gel was applied without occlusion for 8 hours . For limb or torso PHN , gel was applied under occlusion for 24 hours . The 16 subjects with cranial PHN reported pain relief significantly favoring local drug application at 30 minutes , 2 , 4 , and 8 hours . The 23 subjects with torso or limb PHN reported significantly lower pain intensity with local drug application at 8 hours and both pain relief and reduced pain intensity at 24 hours . Remote lidocaine application to mirror‐image skin was no different from placebo . No systemic adverse effects were reported and blood levels did not exceed 0.6 μg/ml . Topical application of 5 % lidocaine gel relieves PHN pain by a direct drug action on painful skin ABSTRACT Objective : Neuropathic pain is often difficult to treat due to a complex pathophysiology . This study evaluated the efficacy , tolerability and safety of combination therapy with 5 % lidocaine medicated plaster and pregabalin for neuropathic pain in patients with post-herpetic neuralgia ( PHN ) or painful diabetic polyneuropathy ( DPN ) . Methods : Patients completing 4-week monotherapy with 5 % lidocaine medicated plaster or pregabalin were enrolled in an 8-week combination phase . Patients with adequate response to monotherapy ( recalled average pain intensity of 4 or less on 11-point numeric rating scale in the previous 3 days [ NRS-3 score ] ) continued their previous therapy , whereas those with insufficient response received combination therapy . Efficacy endpoints included change in NRS-3 from combination phase baseline , Patient and Clinical Global Impression of Change ( PGIC/CGIC ) , and patient 's satisfaction with treatment . Safety evaluation included adverse events ( AEs ) , drug-related AEs ( DRAEs ) , and withdrawal due to AEs . Clinical trial registration : EudraCT No. 2006 - 003132 - 29 . Results : Of 229 patients in the per- protocol set ( PPS : 68 PHN and 161 DPN ) , 71 received 5 % lidocaine medicated plaster monotherapy , 57 had pregabalin added to 5 % lidocaine medicated plaster , 57 pregabalin monotherapy and 44 received 5 % lidocaine medicated plaster in addition to continued pregabalin treatment . There were no meaningful differences in demographic data between the treatment groups . Patients continuing on monotherapy demonstrated additional decreases in NRS-3 scores . Patients receiving combination therapy achieved clinical ly relevant reduction in NRS-3 values in addition to improvement achieved during the 4 weeks of monotherapy . Improvement was similar between the two combination therapy groups . Considerable improvements in patients ’ treatment satisfaction were reported . Incidences of AEs were in line with previous reports for the two treatments and combination therapy was generally well tolerated . Conclusions : In patients with PHN and painful DPN failing to respond to monotherapy , combination therapy with 5 % lidocaine medicated plaster and pregabalin provides additional clinical ly relevant pain relief and is safe and well-tolerated Neuropathic pain treatment remains unsatisfactory despite a substantial increase in the number of trials . This EFNS Task Force aim ed at evaluating the existing evidence about the pharmacological treatment of neuropathic pain . Studies were identified using first the Cochrane Data base then Medline . Trials were classified according to the aetiological condition . All class I and II controlled trials ( according to EFNS classification of evidence ) were assessed , but lower‐class studies were considered in conditions that had no top level studies . Only treatments feasible in an outpatient setting were evaluated . Effects on pain symptoms/signs , quality of life and comorbidities were particularly search ed for . Most of the r and omized controlled trials included patients with postherpetic neuralgia ( PHN ) and painful polyneuropathies ( PPN ) mainly caused by diabetes . These trials provide level A evidence for the efficacy of tricyclic antidepressants , gabapentin , pregabalin and opioids , with a large number of class I trials , followed by topical lidocaine ( in PHN ) and the newer antidepressants venlafaxine and duloxetine ( in PPN ) . A small number of controlled trials were performed in central pain , trigeminal neuralgia , other peripheral neuropathic pain states and multiple‐aetiology neuropathic pains . The main peripheral pain conditions respond similarly well to tricyclic antidepressants , gabapentin , and pregabalin , but some conditions , such as HIV‐associated polyneuropathy , are more refractory . There are too few studies on central pain , combination therapy , and head‐to‐head comparison . For future trials , we recommend to assess quality of life and pain symptoms or signs with st and ardized tools Neuropathic pain ( NeP ) , generated by disorders of the peripheral and central nervous system , can be particularly severe and disabling . Prevalence estimates indicate that 2 % to 3 % of the population in the developed world suffer from NeP , which suggests that up to one million Canadians have this disabling condition . Evidence -based guidelines for the pharmacological management of NeP are therefore urgently needed . R and omized , controlled trials , systematic review s and existing guidelines focusing on the pharmacological management of NeP were evaluated at a consensus meeting . Medications are recommended in the guidelines if their analgesic efficacy was supported by at least one method ologically sound , r and omized , controlled trial showing significant benefit relative to placebo or another relevant control group . Recommendations for treatment are based on degree of evidence of analgesic efficacy , safety , ease of use and cost-effectiveness . Analgesic agents
Output:
| DPN patients experienced a greater improvement in quality of life when using 5%LMP compared to pregabalin .
Adverse events were significantly fewer in patients treated with 5%LMP .
The results suggest that the effects in pain reduction of 5 % lidocaine medicated plaster are comparable to those of amitriptyline , capsaicin , gabapentin and pregabalin .
Topical agents such as 5%LMP may be associated with fewer and less clinical ly significant adverse events than is the case for systemic agents . |
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