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. The modified sphygmomanometer-an instrument to measure muscle strength: a validation study. Defining disease activity in ankylosing spondylitis: is a combination of variables (Bath Ankylosing Spondylitis Disease Activity Index) an appropriate instrument? Clinical assessment of disease activity in rheumatoid arthritis: evaluation of a functional test. 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. Sensitivity of a health status measure to short-term clinical changes in arthritis. 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. 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 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 Disease activity has been defined using a self-administered instrument , focusing on fatigue , axial pain , peripheral pain , enthesopathy and morning stiffness [ Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) ] . This vali date d instrument is simple and takes 40 s to complete , but whether the index is an accurate expression of the component parts , or whether additional weighting would enhance its efficacy , is unclear . METHODS Four hundred and seventy-three patients with ankylosing spondylitis received placebo or active non-steroidal anti-inflammatory drug ( NSAID ) for 6 weeks , and changes between entry and completion were captured by BASDAI and the individual components . Principle component analysis ( PCA ) was used to explore the best combinations of variables in decreasing order of explained total dispersion and to assess whether a single sum ( or algebraic expression ) best defined disease activity status . RESULTS At entry , the correlation between BASDAI and the first axis was 0.99 , 0.11 with the second , and zero thereafter . Data at study end and relating to change revealed a 100 % correlation ( R = 1 ) between the first axis and the sum , with zero for the remainder . CONCLUSIONS The data support BASDAI as being a valid and appropriate composite to define disease activity in ankylosing spondylitis . Developed as a simple sum of its components , BASDAI has excellent content validity A cross sectional analysis of the correlation between clinical , laboratory , and radiological markers of disease activity in 98 patients with classical rheumatoid arthritis ( RA ) is reported . The median age was 38 years , the median age at onset of disease 29 years , and the median duration of disease seven years . The  Keitel function test ( KFT ) showed good correlation with the Ritchie articular index ( RAI ) ( p less than 0.0001 ; r = 0.5 ) and the disability question naire ( DQ ) ( p less than 0.0001 ; r = 0.6 ) . The RAI and DQ correlated weakly with laboratory variables , while the KFT showed significant correlation with the erythrocyte sedimentation rate ( ESR ) , C reactive protein ( CRP ) , and plasma viscosity ( PV ) ( p less than 0.001 ; r = 0.4 ; 0.3 ; 0.4 ) . Only the KFT showed significant correlations with bone mass measurements ( p less than 0.01 ; r = -0.3 ; -0.4 ) , and the Larsen index at the right wrist ( p less than 0.0001 ; r = 0.4 ) . Consensus analysis suggested that the KFT is a useful single clinical test of disease activity in RA . The h and functional index ( HFI ) , a component of the KFT , showed significant correlation with the total KFT ( r = 0.9 ) . Prospect i ve drug trials are needed to establish the value of the HFI in the monitoring of patients with RA 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 To assess the sensitivity of the Arthritis Impact Measurement Scales ( AIMS ) , we analyzed data from 3 clinical trials . One trial involving 255 patients with rheumatoid arthritis ( RA ) was a 12-week , r and omized controlled trail of diclofenac , naproxen , and aspirin . Two trials were open-label studies of 24 weeks duration that included 165 RA and 355 osteoarthritis ( OA ) patients , all of whom were treated with diclofenac .  In addition to the AIMS , tender joint count , morning stiffness , and erythrocyte sedimentation rate were used as outcome measures in the trials . The AIMS results showed substantial improvements in Physical Function , Psychological Status , and Pain , as well as in overall Arthritis Impact . These improvements were detected by the time of the initial outcome assessment at 4 weeks or 8 weeks , and were detected in patients with either OA or RA . These AIMS results closely parallel improvements shown by traditional clinical measures , and demonstrate that the AIMS health status measure is sensitive to improvements in OA as well as in RA . The AIMS also detects responses produced by therapy with nonsteroidal antiinflammatory drugs ( NSAIDs ) , and these improvements can be demonstrated in as short a treatment time as 4 weeks . These findings confirm the utility of the AIMS for assessing outcome in rheumatic disease studies , and they have implication s for the design of future clinical trials of NSAIDs 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 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: In general , estimates of construct validity were lower when vali date d against dissimilar constructs , except for instruments measuring impairments in mental functions .
  CONCLUSION There is a trend that validation against a similar construct yields higher correlation coefficients than validation against a dissimilar construct .
background: PURPOSE This paper focuses on the construct validity of instruments measuring impairments in body structures and function in rheumatic disorders .
  The objective is : 1 ) to make an inventory of constructs , based on the domains of the International Classification of Functioning , Disabilities and Health problems ( ICF ) , against which instruments measuring impairments in body structures and function were vali date d ; 2 ) to analyse whether validation against a similar construct result ed in higher correlation coefficients than validation against a dissimilar construct .