Use of Condition-Specific Patient-Reported Outcome Measures in Clinical Trials among Patients with Wrist Osteoarthritis: A Systematic Review An empirical evaluation of the SF-12, SF-6D, EQ-5D and Michigan Hand Outcome Questionnaire in patients with rheumatoid arthritis of the hand Improving the reliability of event-based laboratory tests of prospective memory Reliability, validity, and responsiveness of the modified Kapandji index for assessment of functional mobility of the rheumatoid hand. WHICH QUESTIONNAIRE IS BEST? THE RELIABILITY, VALIDITY AND EASE OF USE OF THE PATIENT EVALUATION MEASURE, THE DISABILITIES OF THE ARM, SHOULDER AND HAND AND THE MICHIGAN HAND OUTCOME MEASURE The Responsiveness and Minimal Important Change of the Western Ontario Shoulder Instability Index and Oxford Shoulder Instability Score Qualitative analysis of patients’ feedback from a PROMs survey of cancer patients in England Assessing the Motor Status Score: A Scale for the Evaluation of Upper Limb Motor Outcomes in Patients after Stroke The interrater and intrarater reliability of the Modified Ashworth Scale in the assessment of muscle spasticity: limb and muscle group effect. Assessing adherence to the evidence base in the management of poststroke dysphagia Comparison of tools for assessing the methodological quality of primary and secondary studies in health technology assessment reports in Germany Evidence regarding the utility of multiple mini-interview (MMI) for selection to undergraduate health programs: A BEME systematic review: BEME Guide No. 37 Effect of annual intramuscular vitamin D on fracture risk in elderly men and women--a population-based, randomized, double-blind, placebo-controlled trial. The Evidence Project risk of bias tool: assessing study rigor for both randomized and non-randomized intervention studies Conducting experimental research in marginalised populations: clinical and methodological implications from a mixed-methods randomised controlled trial in Kenya Psychometric evaluation of the FACT Colorectal Cancer Symptom Index (FCSI-9): reliability, validity, responsiveness, and clinical meaningfulness. Reliability of the Modified Tardieu Scale and the Modified Ashworth Scale in adult patients with severe brain injury: a comparison study INFANT GROWTH AND HUMAN MILK REQUIREMENTS: A Fresh Approach Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol Assessing the performance of the EQ-VAS in the NHS PROMs programme AMSTAR is a reliable and valid measurement tool to assess the methodological quality of systematic reviews. Reliability and External Validity of AMSTAR in Assessing Quality of TCM Systematic Reviews Systematic Reviews of Animal Studies; Missing Link in Translational Research?
Background . This paper aim ed to identify condition-specific patient-reported outcome measures used in clinical trials among people with wrist osteoarthritis and summarise empirical peer- review ed evidence supporting their reliability , validity , and responsiveness to change . Methods . A systematic review of r and omised controlled trials among people with wrist osteoarthritis was undertaken . Studies reporting reliability , validity , or responsiveness were identified using a systematic reverse citation trail audit procedure . Psychometric properties of the instruments were examined against predefined criteria and summarised . Results . Thirteen clinical trials met inclusion criteria . The most common patient-reported outcome was the disabilities of the arm , shoulder , and h and question naire ( DASH ) . The DASH , the  Michigan H and Outcomes Question naire ( MHQ ) , the  Patient Evaluation Measure ( PEM ) , and the  Patient-Reported Wrist Evaluation ( PRWE ) had evidence supporting their reliability , validity , and responsiveness . A post-hoc review of excluded studies revealed the AUSCAN Osteoarthritis H and Index as another suitable instrument that had favourable reliability , validity , and responsiveness . Conclusions . The DASH , MHQ , and AUSCAN Osteoarthritis H and Index instruments were supported by the most favourable empirical evidence for validity , reliability , and responsiveness . The PEM and PRWE also had favourable empirical evidence reported for these elements . Further psychometric testing of these instruments among people with wrist osteoarthritis is warranted Background The aim of this study was to assess the psychometric properties , namely acceptability , validity , reliability , interpretability and responsiveness of the EuroQol EQ-5D ( EQ-5D visual analogue ( VAS ) and EQ-5D ( utility ) ) , Short Form 12 Dimensions ( SF-12 ) , SF-6D and Michigan H and Outcome Question naire ( MHQ ) in patients with rheumatoid arthritis ( RA ) of the h and . Methods The empirical investigation was based upon data from a r and omised controlled trial of 488 adults with rheumatoid arthritis who had pain and dysfunction of the h and s and /or wrists . Participants completed the EQ-5D , SF-12 and MHQ at baseline and at 4 and 12 months follow up . Acceptability was measured using completion rates over time ; construct validity using the “ known groups ” approach , based on pain troublesomeness ; convergent validity using spearman ’s rho correlation ( ρ ) ; reliability using internal consistency ( Cronbach ’s alpha ) ; interpretability using minimal important differences ( MID ) ; and responsiveness using effect sizes and st and ardised response means ( SRM ) stratified by level of self-rated improvement in h and and wrist function or level of self-rated benefit and satisfaction from trial treatments . Results At baseline , the study population had a mean age of 62.4 years , a mean MHQ score of 52.1 and included 76 % women . The EQ-5D ( utility ) had the highest completion rates across time points . All instruments discriminated between pre-specified groups based on pain troublesomeness . Convergent validity analysis indicated that the MHQ score correlated strongly with the EQ-5D ( ρ = 0.65 ) and SF-6D ( ρ = 0.63 ) utility scores . The MHQ was most responsive at detecting change in indicators of RA pain severity between baseline and 4 months , whilst minimal important differences varied considerably across PROMs . Conclusions The instruments evaluated in this study displayed varying psychometric properties in the context of RA of the h and . The selection of a preferred instrument in evaluative studies should ultimately depend on the relative importance placed on individual psychometric properties and the importance placed on generation of health utilities for economic evaluation purpose Laboratory tests of event-based prospect i ve memory ( ProM ) require participants to perform actions in response to infrequent cues in a background task . We conducted three experiments to assess and improve the reliability of this popular procedure . In Experiment 1 , we tested college students on 2 separate days and found that the alternate-forms reliability of ProM accuracy was quite low ( r = .31 ) , although general knowledge accuracy was more reliable ( r= .89 ) . In Experiment 2 , a statistically significant difference in reliability emerged between conditions with a low ( n = 6 ) versus a high ( n = 30 ) number of ProM targets . Finally , lower ProM accuracy increased reliability in Experiment 3 . Adopting these straightforward changes may enhance the search for individual differences in OBJECTIVE To determine the reliability , validity , and responsiveness of the modified Kap and ji index ( MKI ) . DESIGN Prospect i ve study . A cohort of patients planned for surgery of the wrist and /or fingers was evaluated within 48 hours before surgery and at least 6 months after surgery . SETTING Patients were in hospitalized or private care in France . PARTICIPANTS Patients with rheumatoid arthritis according to criteria of the American College of Rheumatology . Forty-two patients ( 36 women ; mean age , 57.5y ; range , 22 - 80y ) were included in the reliability study . Fifty patients ( 42 women ; mean age , 54.18y ; range , 19 - 77y ) were included in the validity study . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Clinical outcome measures included the MKI , the overall mobility score of the wrist and fingers , the finger mobility score , a visual analog scale ( VAS ) of pain in the h and s and wrists , morning stiffness duration , total score of tenderness , total score of swelling , grip and pinch strength , the H and Functional Index ( HFI ) , and the Cochin rheumatoid h and disability scale . Reliability was studied with the intraclass correlation coefficient ( ICC ) and the Bl and and Altman method . Convergent and divergent validity were assessed with the Spearman correlation coefficient . Responsiveness was assessed by the paired t test , the effect size , and the st and ardized response mean ( SRM ) . RESULTS Interobserver reliability was good with an ICC of.90 , and the Bl and and Altman analysis showed homogeneous distribution of the differences , with no systematic trend . The MKI correlated well with the other mobility measures ( HFI , the finger mobility score measured with the finger goniometer ) , indicating a good convergent validity , and the expected divergent validity with the other outcome measures ( grip and pinch strength , total score of swelling , total score of Ritchie Articular Index , Cochin scale , VAS of pain ) was observed . The 50 patients in the validity study were evaluated twice , before and after surgery , at a mean interval + /- st and ard deviation of 7.16+/-2.10 months ( range , 6 - 15mo ) . Thirty-six patients ( 72 % ) were very satisfied or satisfied with the results of surgery , 7 ( 14 % ) were not satisfied or dissatisfied , and 7 ( 14 % ) were dissatisfied or very dissatisfied . The SRM and effect size values of the MKI were -.19 and -.10 , respectively . Individual changes in the score had the best correlation ( r(s)=.51 ) with overall patient satisfaction . CONCLUSIONS The MKI has excellent validity and reliability . Individual changes in the score are clinical ly relevant . This index can be used in clinical practice and in therapeutic trials ; it needs further study concerning its use for h and surgery The  Patient Evaluation Measure ( PEM ) , The  Michigan H and Outcome Question naire ( MHQ )  and the Disabilities of the Arm , Shoulder and H and ( DASH ) score were assessed independent of their originators for reliability , construct and criterion validity and acceptability , using an ease of use question naire . These were administered in r and om order to 100 patients with different h and and wrist disorders and with different impairments of movement , pain , sensation and strength . The internal consistency of all three question naires was very high suggesting redundancy in the questions . All question naires were reproducible and valid for finger and wrist disorders , but less for nerve disorders . All had poor construct validity . The PEM was the easiest to underst and and complete , taking the least time . Correlation between the scales is high and conversion equations were calculated . All three are reliable and reproducible patient completed question naires , but the PEM is the easiest to use . The validity of all is suspected for nerve disorders • STUDY DESIGN : Prospect i ve cohort study . • BACKGROUND : Patient‐reported outcome measurements ( PROMs ) are widely used to evaluate functional limitations . Considering PROMs for shoulder instability , information is lacking with regard to what constitutes a relevant change from baseline scores . • OBJECTIVES : To evaluate the responsiveness of the Western Ontario Shoulder Instability Index ( WOSI ) and the  Oxford Shoulder Instability Score ( OSIS ) and estimate their minimal important change ( MIC ) . • METHODS : One hundred five consecutive patients with shoulder instability completed 5 PROMs at baseline and at 6‐month follow‐up . The PROMs included the  WOSI and OSIS , the Simple Shoulder Test , the Oxford Shoulder Score , and the Disabilities of the Arm , Shoulder and H and assessment .  Patients also rated their functional change on an anchor question at follow‐up . Responsiveness was evaluated by testing 9 hypotheses regarding predefined correlations between the changes in PROM scores , by calculating the area under the receiver operating characteristic curve and by calculating the st and ardized response mean and effect size statistics . The MIC was determined by identifying the optimal cutoff on the receiver operating characteristic curve . • RESULTS : Seven out of 9 hypotheses ( 78 % ) were confirmed ; as expected , a high correlation ( 0.77 ) was found between change scores of the WOSI and OSIS , whereas the correlations of the change scores of the WOSI and OSIS with those of general shoulder PROMs were slightly lower ( 0.61‐0.75 ) . The area under the curve was 0.83 ( 95 % confidence interval : 0.75 , 0.91 ) for the OSIS and 0.82 ( 95 % confidence interval : 0.74 , 0.90 ) for the WOSI . The MIC was about 6 points for the OSIS and about 14 points for the WOSI . • CONCLUSION : Both the WOSI and OSIS are able to measure change in shoulder function in patients with shoulder instability . The estimated MIC is 6 points for the OSIS ( on a scale from 0 to 48 ) and 14 points for the WOSI ( on a scale from 0 to 100 ) . •KEY WORDS : clinimetrics , functional outcome measures , outcome assessment , Objective This study examined how free-text comments from cancer survivors  could complement formal patient-reported outcome measures ( PROMs ) , as part of the Engl and PROMs survey programme for cancer . Design A qualitative content analysis was conducted of responses to a single open-ended free-text question placed at the end of the cross-sectional population -based postal question naire . Setting Individuals were identified through three UK Cancer Registries and question naires were posted to their home addresses . Participants A r and om sample of individuals ( n=4992 ) diagnosed with breast , colorectal , non-Hodgkins lymphoma or prostate cancer at 1 , 2 , 3 and 5 years earlier . Results 3300 participants completed the survey ( 68 % response rate ) . Of these 1056 ( 32 % ) completed the free-text comments box , indicating a high level of commitment to provide written feedback on patient experience . Almost a fifth ( 19 % ) related experiences of excellent care during the treatment phase , with only 8 % reporting negative experiences . This contrasted with experiences of care after primary cancer treatment where the majority were negative . Factors impacting negatively upon patient-reported outcomes included the emotional impact of cancer ; poor experiences of treatment and care ; comorbidities , treatment side effects , social difficulties and inadequate preparation for a wide range of sometimes long-lasting on-going physical and psychological problems . Mediating factors assisting recovery incorporated both professional-led factors , such as quality of preparation for anticipated problems and aftercare services , and participant-led factors , such as learning from other cancer survivors and self-learning through trial and error . The support of friends and family was also a factor in participants ' outcomes . Conclusions This analysis of free-text comments complements quantitative analysis of PROMs measure 's by illuminating relationships between factors that impact on quality of life ( QoL ) and indicate why cancer patients may experience significantly worse QoL than the general population . The data suggest more systematic preparation and aftercare for individuals to self-manage post-treatment problems might improve QoL outcomes among cancer survivors The  Motor Status Scale ( MSS ) measures shoulder , elbow ( maximum score = 40 ) , wrist , h and , and finger movements ( maximum score = 42 ) , and exp and s the measurement of upper extremity impairment and disability provided by the Fugl-Meyer ( FM ) score . This work examines the interrater reliability and criterion validity of the MSS performed in patients admitted to a rehabilitation hospital 21 ± 4 days after stroke . Using the MSS and the FM , 7 occupational therapists masked to each other ’s judgments , evaluated 12 consecutive patients with stroke . Two therapists evaluated 6 additional patients on consecutive days . Intraclass correlation coefficients were significant for each group of raters for the shoulder/elbow and for the wrist/h and ( P < 0.0001 ) ; test-retest measures were also significant for the shoulder/elbow ( Pearson correlation coefficient r = 0.99 , P < 0.004 ) and for the wrist/h and ( Pearson correlation coefficient r = 0.99 , P < 0.003 ) . The internal item consistency for the overall MSS was significant ( Cronbach alpha = 0.98 , P < 0.0001 ) . Finally the correlation between the MSS and the FM ( R 2 = 0.964 ) was significant ( P < 0.0001 ) . The MSS affords a reliable and valid assessment of upper limb impairment and disability following stroke The Modified Ashworth Scale ( MAS ) is a clinical scale used to assess muscle spasticity . While the evidence indicates that the reliability of the MAS is better in the upper limb and in certain distal muscle groups , no investigation has compared the effect of limbs and muscle groups on the MAS reliability . This study aim ed to evaluate the effect of limb and muscle group on the reliability of the MAS in patients with spastic hemiplegia . Thirty subjects with upper and lower limb muscle spasticity were recruited for this trial . Two female experienced physiotherapists participated in this examination of reliability , and rated each patient in a r and omized order in a single session . For the intrarater reliability , the second rater repeated the test 1 week later . Shoulder adductor , elbow flexor , wrist flexor , hip adductor , knee extensor , and ankle plantar flexor were tested on the hemiplegic side . Results demonstrated moderate inter ( kappa=0.514 , SE=0.046 , p < 0.001 ) and intrarater ( kappa=0.590 , SE=0.051 , p<0.001 ) reliability . For the inter and intrarater reliability , the agreement obtained for the upper and lower limb was similar . In the upper limb , the agreement between raters on the distal wrist flexor was significantly higher than the agreement on the proximal shoulder adductor . In the lower limb , there was a similar agreement between raters on the distal ankle plantar flexor and proximal hip adductor . For within rater , the agreement on the proximal and distal muscles of both limbs was not statistically significant . The Modified Ashworth Scale had moderate reliability . The limbs had no effect on the reliability . The agreement on distal wrist flexor in the upper limb was significantly higher between rater than in the proximal shoulder adductor . The agreement obtained with the MAS was not good , which questions the validity of the measurements Objective : To evaluate the reliability and responsiveness to change of an audit tool to assess adherence to evidence of effectiveness in the  speech and language therapy ( SLT ) management of poststroke dysphagia . Design : The tool was used to review SLT practice as part of a r and omized study of different education strategies . Medical records were audited before and after delivery of the trial intervention . Setting : Seventeen SLT departments in the north-west of Engl and participated in the study . Subjects : The assessment tool was used to assess the medical records of 753 patients before and 717 patients after delivery of the trial intervention across the 17 departments . A target of 10 records per department per month was sought , using systematic sampling with a r and om start . Analysis : Inter- and intra-rater reliability were explored , together with the tool 's internal consistency and responsiveness to change . Results : The assessment tool had high face validity , although internal consistency was low ( r a=0.37 ) . Composite scores on the tool were however responsive to differences between SLT departments . Both inter- and intra-rater reliability ranged from ‘ substantial ’ to ‘ near perfect ’ across all items . Conclusions : The audit tool has high face validity and measurement reliability . The use of a composite adherence score should , however , proceed with caution as internal consistency is low Health care policy background Findings from scientific studies form the basis for evidence -based health policy decisions . Scientific background Quality assessment s to evaluate the credibility of study results are an essential part of health technology assessment reports and systematic review s. Quality assessment tools ( QAT ) for assessing the study quality examine to what extent study results are systematic ally distorted by confounding or bias ( internal validity ) . The tools can be divided into checklists , scales and component ratings . Research questions What QAT are available to assess the quality of interventional studies or studies in the field of health economics , how do they differ from each other and what conclusions can be drawn from these results for quality assessment s ? Methods A systematic search of relevant data bases from 1988 onwards is done , supplemented by screening of the references , of the HTA reports of the German Agency for Health Technology Assessment ( DAHTA ) and an internet search . The selection of relevant literature , the data extraction and the quality assessment are carried out by two independent review ers . The substantive elements of the QAT are extracted using a modified criteria list consisting of items and domains specific to r and omized trials , observational studies , diagnostic studies , systematic review s and health economic studies . Based on the number of covered items and domains , more and less comprehensive QAT are distinguished . In order to exchange experiences regarding problems in the practical application of tools , a workshop is hosted . Results A total of eight systematic method ological review s is identified as well as 147 QAT : 15 for systematic review s , 80 for r and omized trials , 30 for observational studies , 17 for diagnostic studies and 22 for health economic studies . The tools vary considerably with regard to the content , the performance and quality of operationalisation . Some tools do not only include the items of internal validity but also the items of quality of reporting and external validity . No tool covers all elements or domains . Design -specific generic tools are presented , which cover most of the content criteria . Discussion The evaluation of QAT by using content criteria is difficult , because there is no scientific consensus on the necessary elements of internal validity , and not all of the generally accepted elements are based on empirical evidence . Comparing QAT with regard to contents neglects the operationalisation of the respective parameters , for which the quality and precision are important for transparency , replicability , the correct assessment and interrater reliability . QAT , which mix items on the quality of reporting and internal validity , should be avoided . Conclusions There are different , design -specific tools available which can be preferred for quality assessment , because of its wider coverage of substantive elements of internal validity . To minimise the subjectivity of the assessment , tools with a detailed and precise operationalisation of the individual elements should be applied . For health economic studies , tools should be developed and complemented with instructions , which define the appropriateness of the criteria . Further research is needed to identify study characteristics that influence the internal validity of studies Abstract Background : In the 11 years since its development at McMaster University Medical School , the multiple mini-interview ( MMI ) has become a popular selection tool . We aim ed to systematic ally explore , analyze and synthesize the evidence regarding MMIs for selection to undergraduate health programs . Methods : The review protocol was peer- review ed and prospect ively registered with the Best Evidence Medical Education ( BEME ) collaboration . Thirteen data bases were search ed through 34 terms and their Boolean combinations . Seven key journals were h and - search ed since 2004 . The reference sections of all included studies were screened . Studies meeting the inclusion criteria were coded independently by two review ers using a modified BEME coding sheet . Extracted data were synthesized through narrative synthesis . Results : A total of 4338 citations were identified and screened , result ing in 41 papers that met inclusion criteria . Thirty-two studies report data for selection to medicine , six for dentistry , three for veterinary medicine , one for pharmacy , one for nursing , one for rehabilitation , and one for health science . Five studies investigated selection to more than one profession . MMIs used for selection to undergraduate health programs appear to have reasonable feasibility , acceptability , validity , and reliability . Reliability is optimized by including 7–12 stations , each with one examiner . The evidence is stronger for face validity , with more research needed to explore content validity and predictive validity . In published studies , MMIs do not appear biased against applicants on the basis of age , gender , or socio-economic status . However , applicants of certain ethnic and social background s did less well in a very small number of published studies . Performance on MMIs does not correlate strongly with other measures of noncognitive attributes , such as personality inventories and measures of emotional intelligence . Discussion : MMI does not automatically mean a more reliable selection process but it can do , if carefully design ed . Effective MMIs require careful identification of the noncognitive attributes sought by the program and institution . Attention needs to be given to the number of stations , the blueprint and examiner training . Conclusion : More work is required on MMIs as they may disadvantage groups of certain ethnic or social background s. There is a compelling argument for multi-institutional studies to investigate areas such as the relationship of MMI content to curriculum domains , graduate outcomes , and social missions ; relationships of applicants ’ performance on different MMIs ; bias in selecting applicants of minority groups ; and the long-term outcomes appropriate for studies of predictive validity OBJECTIVES Low trauma fractures in older people incur enormous physical , social and economic costs . Previous research indicates that an annual intramuscular injection of vitamin D may reduce fracture rates in this group . This strategy requires validation in a population setting . METHODS R and omized , double-blind , placebo-controlled trial of 300,000 IU intramuscular ( i.m . ) vitamin D2 ( ergocalciferol ) injection or matching placebo every autumn over 3 years . 9440 people ( 4354 men and 5086 women ) aged 75 yrs and over were recruited from general practice registers in Wessex , Engl and . Primary outcome measure was all non-vertebral fracture . Secondary outcomes were hip and wrist fractures , and all falls . RESULTS 585 subjects had incident non-spine fractures  ( hip 110 , wrist 116 , ankle 37 ) . Hazard ratios ( HRs ) for fracture in the vitamin D group were : 1.09 [ 95 % confidence interval ( CI ) 0.93 - 1.28 , P = 0.29 ] for any first fracture , 1.49 ( 95 % CI 1.02 - 2.18 , P = 0.04 ) for hip and 1.22 ( 95 % CI 0.85 - 1.76 , P = 0.28 ) for wrist . There was no effect on falls : HR 0.98 ( 0.93 - 1.04 ) . No protective effect was observed in any subgroup when the cohort was stratified by sex , age , previous fracture or mobility . CONCLUSIONS An annual i.m . injection of 300,000 IU vitamin D2 is not effective in preventing non-vertebral fractures among elderly men and women resident in the general population Background Different tools exist for assessing risk of bias of intervention studies for systematic review s. We present a tool for assessing risk of bias across both r and omized and non-r and omized study design s. The tool was developed by the Evidence Project , which conducts systematic review s and meta-analyses of behavioral interventions for HIV in low- and middle-income countries . Methods We present the eight items of the tool and describe considerations for each and for the tool as a whole . We then evaluate reliability of the tool by presenting inter-rater reliability for 125 selected studies from seven published review s , calculating a kappa for each individual item and a weighted kappa for the total count of items . Results The tool includes eight items , each of which is rated as being present ( yes ) or not present ( no ) and , for some items , not applicable or not reported . The items include ( 1 ) cohort , ( 2 ) control or comparison group , ( 3 ) pre-post intervention data , ( 4 ) r and om assignment of participants to the intervention , ( 5 ) r and om selection of participants for assessment , ( 6 ) follow-up rate of 80 % or more , ( 7 ) comparison groups equivalent on sociodemographics , and ( 8) comparison groups equivalent at baseline on outcome measures . Together , items (1)–(3 ) summarize the study design , while the remaining items consider other common elements of study rigor . Inter-rater reliability was moderate to substantial for all items , ranging from 0.41 to 0.80 ( median κ = 0.66 ) . Agreement between raters on the total count of items endorsed was also substantial ( κw = 0.66 ) . Conclusions Strengths of the tool include its applicability to a range of study design s , from r and omized trials to various types of observational and quasi-experimental studies . It is relatively easy to use and interpret and can be applied to a range of review topics without adaptation , facilitating comparability across review s. Limitations include the lack of potentially relevant items measured in other tools and potential threats to validity of some items . To date , the tool has been applied in over 30 review s. We believe it is a practical option for assessing risk of bias in systematic review s of interventions that include a range of study design ABSTRACT Experimental studies to test interventions for people living with HIV in low- and middle-income countries are essential to ensure appropriate and effective clinical care . The implication s of study participation on outcome data in such population s have been discussed theoretically , but rarely empirically examined . We aim ed to explore the effects of participating in a r and omised controlled trial conducted in an HIV clinic in Mombasa , Kenya . We report qualitative data from the Treatment Outcomes in Palliative Care trial , which evaluated the impact of a nurse-led palliative care intervention for HIV positive adults on antiretroviral therapy compared to st and ard care . Participants in both arms attended five monthly quantitative data collection appointments . Post-trial exit , 10 control and 20 intervention patients participated in semi-structured qualitative interviews , analysed using thematic analysis . We found benefit attributed to the compassion of the research team , social support , communication , completion of patient reported outcome measures ( PROMs ) and material support ( transport reimbursement ) . Being treated with compassion and receiving social support enabled participants to build positive relationships with the research team , which improved mental health and well-being . Open and non-judgmental communication made participants feel accepted . Participants described how repeated completion of the PROMs was a prompt for reflection , through which they began to help themselves and self-care . Participant reimbursements relieved financial hardship and enabled them to fulfil their social responsibilities , enhancing self-worth . These findings emphasise the importance of compassion , support and effective communication in the clinical encounter , particularly in stigmatised and isolated population s , and the potential of the integration of simple PROMs to improve patient outcomes . Participation in research has unexpected positive benefits for participants , which should be taken into account when design ing research in similar population s. Research ers should be aware of the effects of financial reimbursement and contact with research ers in isolated and impoverished communities BACKGROUND Patient-reported outcomes ( PROs ) are essential for evaluating treatment effects on health-related quality of life and symptoms from the patient 's perspective . This study sought to evaluate the psychometric properties of the nine-item Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network Colorectal Cancer Symptom Index ( FCSI-9 ) in a metastatic colorectal cancer ( mCRC ) population . METHODS The FCSI-9 and EQ-5D were administered every 2 - 4 weeks to mCRC subjects in a phase III clinical trial . Three hundred ninety-one mCRC subjects completed the question naires at baseline and at least one follow-up assessment . Internal consistency reliability , test-retest reliability , construct validity , known groups validity , responsiveness , and the minimum important difference ( MID ) of the FCSI-9 were evaluated . RESULTS The internal consistency and test-retest reliability of the FCSI-9 were acceptable ( 0.81 and 0.76 , respectively ) . Construct validity was supported based on moderate correlations with the EQ-5D . Known groups validity was evaluated by examining the FCSI-9 scores of subjects categorized by their Eastern Cooperative Oncology Group performance status ( PS ) score . Subjects with better PS scores reported significantly higher FCSI-9 scores than those with lower PS scores at both baseline and week 8 . Responsiveness , as measured by Guyatt 's statistic , was 0.77 from baseline to week 8 and 0.60 from week 4 to week 12 . Considering all data together , the MID of the FCSI-9 is estimated to be in the range of 1.5 - 3.0 points . CONCLUSION Results provide preliminary evidence of the reliability , validity , and responsiveness of the FCSI-9 Objective : To assess and to compare the reliability of the Modified Tardieu Scale with the Modified Ashworth Scale in patients with severe brain injury and impaired consciousness . Design : Cross-sectional observational comparison study . Setting : An early rehabilitation centre for adults with neurological disorders . Subjects : Thirty patients with impaired consciousness due to severe cerebral damage of various aetiologies . Measurement protocol : Four experienced physical therapists rated each patient in a r and omized order once daily for two consecutive days . Shoulder , elbow , wrist , hip , knee and ankle spasticity were assessed by the use of Modified Tardieu Scale and Modified Ashworth Scale data collection procedures . Main outcome measures : Test - retest and inter-rater reliability ( k = kappa value ) of the Modified Tardieu Scale and the Modified Ashworth Scale .  Results : The test-retest reliability of the Modified Ashworth Scale was moderate to good ( k = 0.47 - 0.62 ) and of the Modified Tardieu Scale moderate to very good ( k = 0.52 - 0.87 ) . Test - retest reliability was significantly higher within the Modified Tardieu Scale in comparison with the Modified Ashworth Scale ( Z<1.96 ; p<0.05 ) except for shoulder extensor and internal rotator muscles ( Z<1.96 ; p<0.05 ) . Although inter-rater reliability of both scales was poor to moderate ( Modified Ashworth Scale : k = 0.16 - 0.42 ; Modified Tardieu Scale : k = 0.29 - 0.53 ) , significantly higher k-values were revealed with the Modified Tardieu Scale for all tested muscle groups ( Z<1.96 ; p<0.05 ) except for wrist extensors ( Z<1.96 ; p<0.05 ) . Conclusion : In patients with severe brain injury and impaired consciousness the Modified Tardieu Scale provides higher test-retest and inter-rater reliability compared with the Modified Ashworth  Scale and may therefore be a more valid spasticity scale in adults Abstract The relationship between growth and the breast-milk plus complementary food intake of a group of British babies has been studied prospect ively up to 8 months . From the data the human milk needs of  solely breast-fed children to grow along the 5th , 50th , and 95th Gentile of the NCHS st and ard have been predicted using multiple regression analysis . The values obtained are substantially lower than previous estimates and they may form a more practical guideline for the evaluation of lactational adequacy within a community . Individual variation is important . It is futile to identify a single age when breast-feeding becomes inadequate as the sole source of food Background UK-wide national clinical guidelines promote routine 6-month post-stroke follow-up assessment . However , as part of this 6-month assessment little information is gathered from the patient ’s perspective . The means of collecting this patient-centred information might be served best by a patient-reported outcome measure ( PROM ) at the 6-month assessment time point . Currently , four different methods of 6-month follow-up assessment occur ; the most common being face-to-face interview followed by telephone interview , postal question naire and online question naire . Therefore , this study will investigate if the acceptability of telephone , online or postal administration of a PROM at the 6-month post-stoke time point is not inferior to face-to-face administration . Methods / design A UK multicentre , blinded ( analyst and research er ) , pragmatic , non-inferiority study , with 80 % power using a 2.5 % non-inferiority margin was design ed to compare the acceptability of three modes of administration ( telephone interview , postal question naire and online question naire ) compared with face-to-face interview administration of a PROM . We plan to approach and r and omise a minimum of 808 potentially eligible participants , 202 participants per group . Discussion The aim of this ongoing research is to underst and if there is a difference between face-to-face administration and the other three methods of administering a PROM as a patient-centred supplement to the 6-month review for stroke survivors . In utilising a pragmatic design , it is believed that this study will offer UK wide generalisable results , of the acceptability of the methods under investigation , to inform clinicians and commissioners of stroke services . Trials registration Clinical Trials.gov : NCT03177161 . Registered on 6 June 2017 Objectives The study aims to increase knowledge about the performance of the EuroQol-visual analogue scales ( EQ-VAS ) in the UK NHS patient-reported outcome measures ( PROMs ) programme , which covers groin hernia , hip and knee replacement and varicose vein surgery , and make suggestions for improved collection , coding and analysis of data . Methods Four hundred scanned images of matched before- and -after EQ-VAS PROMs responses were selected at r and om . These were classified according to the different ways in which they were completed . Patient-level PROMs programme data linked to Hospital Episode Statistics for all patients from April 2009 to February 2011 were used to analyse the relationship between the EQ-VAS and the EQ-5D profile , index-weighted profile and condition-specific instruments . The linked PROMs and HES data comprise 331,951 anonymised patient records . Results A large majority ( 95 % ) of EQ-VAS responses were completed in an unambiguous way , but only a minority ( 45 % ) conformed strictly to the instructions given , posing challenges for data coding . The EQ-VAS data have a predictable and consistent relationship with the EQ-5D profile , although the correlations between the EQ-VAS and other measures of patient-reported health , both before and after surgery and in the change between them , are weak . Conclusions EQ-VAS data might be improved by providing better guidance on collection and coding . It is argued that the observed differences in results from EQ-VAS and other measures of health reflect the fact that it measures a broader underlying construct of health , arguably providing a means of summarising overall health that is closer to the patient ’s perspective OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess  systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review Objective . The aim of this study is to measure the reliability and external validity of AMSTAR by applying it to a sample of TCM systematic review s. Study Design and Methods . We tested the agreement , reliability , construct validity , and feasibility of AMSTAR through comparisons with OQAQ . Statistical analyses were performed by using SPSS 13.0 . Results . A r and om of sample with 41 TCM systematic review s was selected from a data base . The interrater agreement of the individual items of AMSTAR was moderate with a mean kappa of 0.50 ( 95 % CI : 0.26 , 0.73 ) . The ICC for AMSTAR against OQAQ ( total score of 9 items , excluding item 10 ) was 0.87 ( 95 % CI : 0.76 , 0.93 ) . Conclusions . Although there is room for improvement on few items , the new tool is reliable , valid , and easy to use for method ological quality assessment of systematic review s on TCM Background The method ological quality of animal studies is an important factor hampering the translation of results from animal studies to a clinical setting . Systematic review s of animal studies may provide a suitable method to assess and thereby improve their method ological quality . Objectives The aims of this study were : 1 ) to evaluate the risk of bias assessment in animal-based systematic review s , and 2 ) to study the internal validity of the primary animal studies included in these systematic review s. Data Sources We systematic ally search ed Pubmed and Embase for SRs of pre clinical animal studies published between 2005 and 2012 . Results A total of 91 systematic review s met our inclusion criteria . The risk of bias was assessed in 48 ( 52.7 % ) of these 91 systematic review s. Thirty-three ( 36.3 % ) SRs provided sufficient information to evaluate the internal validity of the included studies . Of the evaluated primary studies , 24.6 % was r and omized , 14.6 % reported blinding of the investigator/caretaker , 23.9 % blinded the outcome assessment , and 23.1 % reported drop-outs . Conclusions To improve the translation of animal data to clinical practice , systematic review s of animal studies are worthwhile , but the internal validity of primary animal studies needs to be improved . Furthermore , risk of bias should be assessed by systematic review s of animal studies to provide insight into the reliability of the available evidence
Only the DASH and PRWE have evidence of reliability , validity , and responsiveness in patients with traumatic injuries to the h and and wrist ; other measures either have incomplete evidence or evidence gathered in a nontraumatic population .
Conclusions : The DASH and PRWE both have evidence of reliability , validity , and responsiveness in a h and and wrist trauma population .
Other PROMs used to assess h and and wrist trauma patients do not .
Background : Patient-reported outcome measures ( PROMs ) are important tools for assessing outcomes following injuries to the h and and wrist .
Many commonly used PROMs have no evidence of reliability , validity , and responsiveness in a h and and wrist trauma population .
This systematic review examines the PROMs used in the assessment of h and and wrist trauma patients , and the evidence for reliability , validity , and responsiveness of each measure in this population .