title: Outcome assessment in clinical trials. Evidence for the sensitivity of a health status measure. Which outcome measures should be used in rheumatoid arthritis clinical trials? Clinical and quality-of-life measures' responsiveness to treatment in a randomized controlled trial. Preliminary core set of domains and reporting requirements for longitudinal observational studies in rheumatology. The modified sphygmomanometer-an instrument to measure muscle strength: a validation study. Reliability, validity, and responsiveness of the modified Kapandji index for assessment of functional mobility of the rheumatoid hand. Use of a numerical rating scale as an answer modality in ankylosing spondylitis-specific questionnaires. An articular index for the assessment of osteoarthritis. Grading of tenderness as a source of interrater error in the Ritchie articular index. Comparisons of Five Health Status Instruments for Orthopedic Evaluation A simple pressure dolorimeter for the quantification of joint tenderness in inflammatory arthritis Comparative measurement efficiency and sensitivity of five health status instruments for arthritis research. Evaluation of joint mobility in rheumatoid arthritis trials: the value of the EPM-range of motion scale. The Beck Depression Inventory, Center for Epidemiological Studies Depression Scale (CES-D), and General Well-Being Schedule depression subscale in rheumatoid arthritis. Criterion contamination of responses. Effect Sizes for Interpreting Changes in Health Status An assessment of grip strength measurement in rheumatoid arthritis. Evaluation of a functional index and an articular index in ankylosing spondylitis. Studies with an enthesis index as a method of clinical assessment in ankylosing spondylitis. The assessment of disease activity in rheumatoid arthritis using a multivariate analysis. Validity and reliability of Swedish WOMAC osteoarthritis index: A self-administered disease-specific questionnaire (WOMAC) versus generic instruments (SF-36 and NHP) An electronic method for measuring joint tenderness in rheumatoid arthritis. Validity and reliability of the twenty-eight-joint count for the assessment of rheumatoid arthritis activity.
abstract: Health status measures are conceptually relevant to the assessment of clinical outcome in the rheumatic diseases , but their ability to detect meaningful changes in health has not been clearly demonstrated . This report describes the performance of a self-administered health status question naire in a r and omized , double-blind , 21-week comparison of placebo , oral gold , and injectable gold in rheumatoid arthritis patients . Outcome was assessed by st and ard clinical measures , including joint count , grip strength , and laboratory tests , and by the Arthritis Impact Measurement Scales , a reliable and valid health status measure that assesses physical disability , psychological status , and pain . Data from the clinical and health status measures produced highly similar conclusions : injectable and oral gold are more effective than placebo for rheumatoid arthritis , and injections are slightly more effective than oral gold . The health status measure was thus quite sensitive to clinical ly meaningful drug-induced improvements . These findings provide justification for the further application of health status measures to clinical trials of chronic disease OBJECTIVE To determine the discriminant validity of the core set of outcome measures proposed by the American College of Rheumatology ( ACR ) and the Outcome Measures in Clinical Trials ( OMERACT ) conference committee to be used in clinical trials of rheumatoid arthritis ( RA ) . METHODS Utilizing data from a multicenter r and omized double-blind clinical trial of low-dose cyclosporine and placebo in RA , we estimated the relative efficiency ( RE ) of measures to detect a treatment effect ( relative to tender joint count , which was assigned a value of 1 ) . Four pain measures ( 10-cm visual analog scale [ VAS ] , 5-point categorical scale , Health Assessment Question naire [ HAQ ] pain index , Arthritis Impact Measurement Scales [ AIMS ] pain score ) and 3 quality -of-life measures ( Problem Elicitation Technique [ PET ] , HAQ , AIMS )  were compared . RESULTS Physician and patient global measures were the most responsive instruments , although neither was statistically superior to tender joint count . Swollen joint count , grip strength , pain measured on a 10-cm VAS , and functional status as measured by the PET and HAQ were all of intermediate responsiveness . Morning stiffness , 5-point pain scale , and erythrocyte sedimentation rate were the least responsive instruments . CONCLUSION This study provides further evidence to support the core set of outcome measures proposed by the ACR and OMERACT Observational and longitudinal observational studies ( LOS ) provide essential information about the course and outcome of rheumatic disorders that can not be provided by r and omized controlled trials , and they constitute the major clinical scientific communication in rheumatology . There has been no consensus as to the full and appropriate content of LOS . This report defines a core set of domains and reporting requirements for LOS . At the 1998 OMERACT IV Conference a consensus process evaluated the literature of rheumatology in light of the constructs , variables , and outcomes of rheumatology by using introductory lectures , nominal groups , and plenary sessions . The result of this process was to identify 5 " core " domains that should be included in every LOS : Health Status , Disease Process , Damage , Mortality , and Toxicity/Adverse Reactions . Two additional domains , Work Disability and Costs , were recognized as important , but need not be used in all LOS . Eleven subdomains were identified that divided the domains into convenient clinical and conceptual units . A set of reporting requirements was also determined . The core recommendations , which follow on the WHO ICIDH-2 outline , are not disease-specific ; the substitution of different " disease process " and " damage " measures make them suitable for many rheumatic disorders . The core set is intended to serve as a core for LOS in almost all rheumatic conditions Is the modified aneroid sphygmomanometer a valid instrument to measure isometric quadriceps strength ? Three techniques were compared : the cuff method , in which the original cuff and bladder were folded then secured by rubber b and s ; the bag method , in which the folded bladder was secured in a sewn bag ; and a st and ard method , employing weights . Using a design to control for method and order of measurement , five physiotherapists measured quadriceps muscle strength in five rheumatoid patients . The design features explained 97 % of the variation amongst the measurements . Order of observation and the observers had no effect on the measurements . Patients were quite different and methods of measurement were different . The cuff and bag methods obtained higher readings than the weights , and the bag readings were higher than the cuff . Compared to the st and ard weights , the sphygmomanometer methods were : equally sensitive and reproducible , performed in 16th of the time , independent of gravity and potentially adaptable to 24 different muscle groups 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 OBJECTIVES To determine the agreement of scores on the original visual analog scale ( VAS ) or Likert scale of the Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , Bath Ankylosing Spondylitis Functional Index ( BASFI ) , and Dougados Functional Index ( DFI ) with scores on a numerical rating scale ( NRS ) . To assess the reproducibility and responsiveness of the instruments with the original scale and NRS . METHODS Five hundred thirty-six patients with ankylosing spondylitis from the Netherl and s , Mexico , and Switzerl and completed a question naire  in which all questions from the BASDAI , BASFI , and DFI were presented twice in r and om order with an 11-point NRS and either a 10-cm VAS ( BASDAI and BASFI ) or a 5-point Likert scale ( DFI ) . Agreement of scores using Bl and -Altman plots and intraclass correlation coefficients ( ICCs ) , reproducibility using ICCs , and responsiveness were assessed . RESULTS Large variability between the scores on the original scales and the NRS was found in individual questions of all 3 question naires , although total scores showed ICCs of at least 0.88 . Reproducibility of all answer modalities showed low ICCs in individual questions , but moderate to good ICCs in total scores ( Dutch group 0.62 - 0.89 ; Mexican group 0.53 - 0.72 ) . Moderate to large effects ( 0.48 - 1.04 ) were found in responsiveness scores in the 3 question naires . No major differences in reproducibility and responsiveness between the answer modalities were found . CONCLUSION Although large variability between the scores on the original answer scales and the NRS was observed , the BASDAI , BASFI , and DFI can be administered with an NRS , which does not show important differences compared with the original scales An articular index was devised for the sequential assessment of patients with osteoarthritis ( OA ) . Forty-eight joint units , chosen to reflect the characteristic pattern of the disease , were scored for tenderness on pressure or movement on a 4-point scale . Four observers examined patients to assess inter- and intraobserver error . The index was highly reproducible both within and between observers ; intraobserver error was , however , significantly smaller . In a double-blind , cross-over trial the index was sufficiently sensitive to detect a statistically significant difference between the responses of patients with OA to an anti-inflammatory agent and to a simple analgesic . It is likely to be a useful addition to current methods of measurement in osteoarthritis To assess the effect of grading of tenderness on the interrater reliability of the Ritchie articular index ( RAI ) , 3 physicians recorded independent joint scores on each of 18 patients , examined in r and om order . Our results indicate that close agreement ( Intraclass Correlation Coefficient = 0.85 ) can be achieved on global RAI scores , and that raters can achieve reasonable agreement ( kappa = 0.40 - 0.59 ) on the absolute presence or absence of tenderness of individual joints . By contrast , interrater agreement hardly exceeds the chance level ( kappa = 0.008 - 0.148 ) when degree of tenderness is independently assessed . The grading system of the RAI may thus be implicated as an important source of the instrument 's interrater error This study represents a long-term effort to find optimal techniques for evaluating outcome in patients who have undergone total joint arthroplasty . Sensitivity of five health status question naires was studied in a longitudinal evaluation of orthopedic surgery . The question naires ( Arthritis Impact Measurement Scales [ AIMS ] , Functional Status Index [ FSI ] ,  Health  Assessment  Question naire [ HAQ ] , Index of  Well  Being [ IWB ] , and Sickness Impact Profile  [ SIP ] ) were administered to 38 patients with end-stage arthritis at three points in time : two weeks before hip or knee arthroplasty , and at three-month and 12- to 15-month follow-up . Response values ( i.e. , changes within patients ) were calculated on four scales : global health , pain , mobility , and social function . By the three-month follow-up , most instruments detected large mean responses in global health , pain scores , and mobility . Smaller changes on these scales were found between three and 12 to 15 months . Social function showed small to modest gains at successive follow-ups . St and ardized response means were calculated to assess sensitivity to detect change . Confidence intervals for these indices were constructed using a jackknife procedure , and significance tests were performed by pairing selected indices . Finally , the study projected sample sizes required to assess a new therapy , using each response . These statistical tools facilitated comparisons among instruments and may prove useful in other setting Summary A simple pressure dolorimeter for the detection and quantification of joint tenderness is described and evaluated . The pressure dolorimeter was more sensitive than a modified Ritchie Index in measuring degree of joint tenderness and as sensitive in detecting tender joints . The interobserver error of the pressure dolorimeter was low , and in a drug withdrawal study , the pressure dolorimeter was able to detect change in joint tenderness whereas the conventional Ritchie Index was not . These results suggest that the pressure dolorimeter is a simple , reliable and sensitive instrument for measuring joint tenderness in patients with inflammatory joint disease . It is also inexpensive and readily available Five health status instruments were administered in r and om order to 50 arthritis patients before and after total joint arthroplasty . Relative efficiency and sensitivity in measurement of change in pain , mobility and physical function , social role and social activity , and global health were assessed . The instruments had highly correlated scores , but had differences in certain dimensions . Inter-instrument differentials were larger for social and global outcomes than for pain or mobility . NO single instrument consistently outperformed the others . A method for determining relative efficiency is described OBJECTIVE Evaluation of joint range of motion ( ROM )  is important in the therapeutic approach to patients with rheumatoid arthritis ( RA ) . The reliability , construct validity and sensitivity to change of the Escola Paulista de Medicina (EPM)--range of motion scale that measures 10 distinct movements of small and large joints were examined . METHODS Fifty patients with active RA who were participating in an inpatient multidisciplinary treatment program were examined by 2 investigators . Twenty-five of the patients were examined both at admission and at discharge from the hospital . RESULTS The mean EPM-ROM score at study entry was 11.52 ( SD + /- 3.80 ) . The intra and inter-observer reliability of the EPM-ROM scale was high , with correlations of r = 0.91 and r = 0.85 , respectively . There was a good correlation between the EPM-ROM scale and measures of functional ability . Correlations with measures of disease activity were poor . After a mean duration of the treatment program of 4.2 weeks , patients generally improved in variables of functional status and disease activity . The improvement of the EPM-ROM score ( mean difference 1.58 , 95 % CI 0.84 - 2.32 ) was generally larger than improvement in other variables of functional status . CONCLUSION The EPM-ROM scale is a reliable instrument , and according to its correlation with measures of functional status , relevant to the performance of activities of daily living . It showed a good response to improvement of functional status and disease activity and was more sensitive to changes than other variables of functional status Three widely used  depression scales -- the  Beck Depression Inventory ( BDI ) , Center for Epidemiological Studies Depression scale ( CES-D ) , and  General Well-Being Schedule depression subscale (GWB-D)--were studied in rheumatoid arthritis ( RA ) . Twenty-three rheumatologists identified 19 of the 45 items on these three question naires as likely to differ in patients with RA and control subjects because of the presence of RA , regardless of psychological status . Responses to 13 of these 19 individual scale items , design ated as " RA-related items , " differed significantly in 41 RA patients versus 57 age-matched control subjects . Only three of the other 26 items differed significantly in the two groups . These data extend evidence that responses of people with RA on widely used depression scales might be affected by somatic disease regardless of psychological status Health status measures are being used with increasing frequency in clinical research . Up to now the emphasis has been on the reliability and validity of these measures . Less attention has been given to the sensitivity of these measures for detecting clinical change . As health status measures are applied more frequently in the clinical setting , we need a useful way to estimate and communicate whether particular changes in health status are clinical ly relevant . This report considers effect sizes as a useful way to interpret changes in health status . Effect sizes are defined as the mean change found in a variable divided by the st and ard deviation of that variable . Effect sizes are used to translate “ the before and after changes ” in a “ one group ” situation into a st and ard unit of measurement that will provide a clearer underst and ing of health status results . The utility of effect sizes is demonstrated from four different perspectives using three health status data sets derived from arthritis population s administered the Arthritis Impact Measurement Scales ( AIMS ) . The first perspective shows how general and instrument-specific benchmarks can be developed and how they can be used to translate the meaning of clinical change . The second perspective shows how effect sizes can be used to compare traditional clinical measures with health status measures in a st and ard clinical drug trial . The third application demonstrates the use of effect sizes when comparing two drugs tested in separate drug trials and shows how they can facilitate this type of comparison . Finally , our health status results show how effect sizes can supplement st and ard statistical testing to give a more complete and clinical ly relevant picture of health status change . We conclude that effect sizes are an important tool that will facilitate the use and interpretation of health status measures in clinical research in arthritis and other chronic diseases The intra-observer , inter-observer , day-to-day , week-to-week and diurnal variations in grip strength measurement have been studied in patients with rheumatoid arthritis . In addition , the changes in grip strength measurements in a double-blind , cross-over trial of Sodium Salicylate and Prednisolone are reported . An intra-observer error of up to 9 mmHg was found and , in addition , there was also considerable variation in grip strength measurements between different observers . Grip strength is responsive to Sodium Salicylate and Prednisolone therapy but the change in association with the former was minimal — indicating insensitivity of the test . In clinical trials , measurement of grip strength should not only be performed by one observer for each patient but measurements should be made at the same time of day because of its diurnal variation . The inherent errors in the method should be considered when interpreting results of grip strength measurement in such trials We describe an index of functional impairment and a system of scoring joint tenderness for use in the assessment of ankylosing spondylitis . The functional index consists of 20 questions and the articular index is based on the scoring of a total of 10 joint responses after movement or firm digital pressure . These indices are simple to establish and not time consuming . They have a high degree of intra- and interobserver reproducibility . The indices showed changes in short term clinical trials of antiinflammatory drugs ; these changes were highly correlated with the patient 's overall assessment of his own clinical condition The histopathological characteristic of ankylosing spondylitis ( AS ) is the presence of chronic enthesitis . Our aim was to develop a clinical measurement of the severity of tenderness over entheses . The scoring system was based on the patients ' response to palpation over entheses easily accessible to examination . The enthesis index ( EI ) correlated with pain ( r = 0.67 , p less than 0.01 ) and stiffness ( r = 0.46 , p less than 0.05 ) scores . A single , blind , crossover study was conducted to determine the sensitivity of the index to change in clinical state associated with non-steroidal antirheumatic drug therapy and to record the interobserver variability . The index showed significantly lower scores after one week 's drug treatment ( p less than 0.05 ) . The EI is a convenient , non-invasive measure of disease severity in patients with AS . Potential applications include the assessment of enthesitis in other polyarthritides and a means of distinguishing clinical ly between severity of enthesitis and synovitis in different types of polyarthritis A simple method of assessing ' index of disease activity ' ( IDA ) in rheumatoid arthritis ( RA ) using a multivariate analysis ( MVA ) comprising morning stiffness ( MS ) , pain scale ( PS ) , grip strength ( GS ) , articular index ( AI ) , haemoglobin ( Hb ) and erythrocyte sedimentation rate ( ESR ) is described . The IDA of 99 patients with RA was assessed using MVA . The method could be used reliably and readily for r and om or longitudinal assessment , in drug trials and for comparing disease activity with other objective indices We assessed whether a disease-specific , self-administered question naire could replace a generic instrument as an outcome tool after total hip replacement , and tested the validity and reliability of the Swedish WOMAC osteoarthritis index . 58 patients operated on with total hip arthroplasty 2 - 10 years ago were r and omized to the study . All patients were asked to answer one disease-specific question naire ( WOMAC osteoarthritis index ) and two generic instruments ( NHP and SF-36 ) in the same week . The procedure was repeated after 4 weeks . We tested content validity , construct validity , criterion validity , test-retest reliability and internal consistency reliability according to total score , domains and items . We found that both the generic instruments ( NHP and SF-36 ) and the disease-specific test ( WOMAC ) had a high validity , i.e. , measuring what they were supposed to measure ( high validity ) . The question naires were also reproducible over time ( high reliability ) . We suggest the Swedish WOMAC to be used after total hip arthroplasty in future studies OBJECTIVE To test the precision of a new electronic method for measuring joint tenderness . METHOD Joint tenderness was measured in 30 patients with rheumatoid arthritis , using an electronic dolorimeter . The results were compared with joint tenderness counts , which were made according to the American Rheumatism Association ( ARA ) methods . RESULTS The intra-observer variability using the electronic method was significantly decreased compared with the conventional ARA joint tenderness counts . CONCLUSION The electronic method is more efficient for use in clinical trials than is the conventional ARA joint tenderness count OBJECTIVE To investigate the validity of the 28-joint count for assessment of joint involvement in patients with rheumatoid arthritis ( RA ) . METHODS Joint involvement as determined by the 28- and the 66/68-joint count was compared using data from 735 prospect ively studied RA patients . RESULTS The joints included in the 28-joint count were more commonly involved than other joints , and findings from the 28-joint count correlated highly with those from the 66/68-joint count in all analyses . CONCLUSION The 28-joint count is a reliable and valid measure for joint assessment . It is easier to perform than the 66/68-joint count , and it addresses the joints that are critically involved
target: Only a limited number of the identified instruments for the assessment of impairments is both reliable and valid .
background: The objective of this study is to provide a critical overview of available instruments to assess impairments in patients with rheumatic disorders , and to recommend reliable and valid instruments for use in allied health care and rehabilitation medicine .