title: 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. Comparison of two approaches to measuring change in health status in rheumatoid arthritis: the Health Assessment Questionnaire (HAQ) and modified HAQ. The Sickness Impact Profile: Development and Final Revision of a Health Status Measure 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. Effect Sizes for Interpreting Changes in Health Status Quality of life assessment: a comparison of four questionnaires: for measuring improvements after total hip replacement The limited value of the Health Assessment Questionnaire as an outcome measure in short term exercise trials. Repeated validation of parental self-reported smoking during pregnancy and infancy: a prospective cohort study of infants at high risk for allergy development.
abstract: 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 As an alternative to the calculation of change scores for health status question naires used in clinical trials or longitudinal studies , transitional questions have been developed for patients to assess changes directly themselves . Here the original Health Assessment Question naire ( HAQ ) is compared with a modified version of the HAQ ( MHAQ ) which contains transition questions used at follow up . These , together with a set of st and ard rheumatological tests , were all completed by 100 patients with rheumatoid arthritis on two occasions , three months apart . Change scores were calculated for the HAQ and for the clinical measures and compared with the MHAQ . The results were strikingly in favour of encouraging patients to assess their own degree of change through the use of transition questions in the MHAQ The final development of the Sickness Impact Profile ( SIP ) , a behaviorally based measure of health status , is presented . A large field trial on a r and om sample of prepaid group practice enrollees and smaller trials on sample s of patients with hyperthyroidism , rheumatoid arthritis and hip replacements were undertaken to assess reliability and validity of the SIP and provide data for category and item analyses . Test-retest reliability ( r = 0.92 ) and internal consistency ( r = 0.94 ) were high . Convergent and discriminant validity was evaluated using the multitrait – multi method technique . Clinical validity was assessed by determining the relationship between clinical measures of disease and the SIP scores . The relationship between the SIP and criterion measures were moderate to high and in the direction hypotheszed . A technique for describing and assessing similarities and differences among groups was developed using profile and pattern analysis . The final SIP contains 136 items in 12 categories . Overall , category , and dimension scores may be calculated 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 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 Summary Three experimental question naires were compared with the Influence of Rheumatic Diseases on Health and Lifestyle ( IRGL ) question naire , a Dutch version of the Arthritis Impact Measurement Scales . Sixty-two patients with osteoarthritis ( OA ) and 35 patients with rheumatoid arthritis ( RA ) , all of whom underwent hip arthroplasty , completed the study . Results showed that visual analogue scales for pain , stiffness , fatigue , and anxiety were strongly correlated with a number of the IRGL scales . Patient preference scales were sensitive to change and provided additional information on aspects of the patients ' quality of life ( QOL ) that were felt to be important by the patients themselves . The question naire on performance in various roles in life was insensitive to change . In existing question naires , there is an attempt to represent the concept of QOL in terms of its most important aspects . Such realizations of the concept of QOL are not entirely suitable for application in clinical trials . The IRGL is overly complex , and its sometimes comprehensive scales do not deal with the possible effects of treatment . Neither of these properties is conducive to sensitivity to change . Visual analogue scales reduce the complexity . A simpler representation of QOL that can evaluate aspects relevant to treatment is recommended OBJECTIVE To examine the value of the  Health Assessment Question naire ( HAQ ) as an outcome measure in short term exercise trials . We studied the association of the objectives of exercise , namely joint mobility , muscle strength , and physical condition , with the HAQ . METHODS Data for 100 patients with rheumatoid arthritis ( RA ) included in a study to examine the effect of exercise therapy were used for secondary analysis . Disease activity was determined by the disease activity score ( DAS3 ) , pain was scored on a visual analog scale ( VAS ) , and depression was measured by the Dutch Arthritis Impact Measurement Scale . Aerobic capacity ( VO2max ) estimated from a submaximal ergometer test , grip strength ( kPa ) ,  isokinetic muscle strength of the knee  ( Nm/kg ) , and the  Escola Paulista de Medicina range of motion ( EPM-ROM ) score , a measure of general flexibility , were used as indicators for physical impairments . All variables were entered in a forward multiple regression analysis with the HAQ as dependent variable . RESULTS The HAQ was significantly correlated with the DAS3 score ( r = 0.53 ) , pain ( r = 0.51 ) , depression ( r = 0.40 ) , joint mobility ( r = 0.27 ) , quadriceps strength ( r = -0.35 ) , and grip strength ( r = -0.50 ) , but not with physical condition . The DAS3 score was first entered in the multiple regression analysis model , followed by pain , quadriceps strength , and grip strength ( R2 = 0.45 ) . After 12 weeks of exercise therapy changes in the HAQ were significantly correlated with changes in pain ( r = 0.41 ) , in depression ( r = 0.33 ) , and in quadriceps strength ( r = -0.25 ) , but not with changes in joint mobility or physical condition . CONCLUSION Physical impairments are weakly associated with the HAQ .  The HAQ is not an appropriate instrument to detect changes in physical impairments due to short term exercise therapy Exposure to environmental tobacco smoke ( ETS ) during fetal life and infancy is closely related to the smoking habits of the parents . Estimates of exposure to ETS require valid and detailed information on changes in cigarette smoking over time . The objective was to test the validity of self-reported smoking among parents during pregnancy and early childhood in a cohort of children at high risk for allergy development by measurement of  exhaled carbon monoxide ( CO ) . The cohort comprised 117 families enrolled from the general population of pregnant women at admission to antenatal care . Data on parental tobacco smoking were obtained by interview and  exhaled CO  was measured ( Micro-Smokerlyzer(R ) ) in parents twice during pregnancy and when the child was 6 and 18 months old . The median ( range ) exhaled CO levels were 3 ( 0 - 10 ) parts per million ( ppm ) for non-smokers and 15 ( 1 - 39 ) ppm for smokers ( P < 0.0005 ) . A receiver operating characteristic ( ROC ) analysis was performed at each examination . The areas under the ROC curve were high for both mothers ( between 0.88 and 0.99 ) and fathers ( between 0.87 and 0.89 ) , indicating exhaled CO as a good diagnostic tool for determining smoking status . Comparing the ROC areas obtained for mothers from late pregnancy and during infancy with the area from early pregnancy showed no statistical differences ( P = 0.21 , 0.43 and 0.44 respectively ) and the same was true for fathers during infancy ( P = 0.81 ) . The level of 8 ppm was used as the cut-off between smokers and non-smokers , based on data from a pilot study . Using CO as a diagnostic tool for smoker status showed very high specificity ( between 97 and 100 % ) , indicating that very few persons cl aim ing to be non-smokers had CO levels higher than 8 ppm . In conclusion , the validity of interview-obtained self-reported smoking among parents during pregnancy and early childhood was high . Repeated interviews and CO measurements in a prospect i ve study design did not change the validity , indicating a low risk of information bias . A structured interview combined with measurement of exhaled CO is a valid and reliable method for estimating ETS exposure to the fetus and young infant
target: No difference was found in the strength of correlation between validation against the most similar construct versus validation against the least similar construct .
  It is concluded that the Arthritis Impact Measurement Scale ( AIMS ) is the most suitable instrument for the assessment of disabilities in personal care
background: OBJECTIVES The first aim was to make an inventory of available instruments and question naires for the assessment of  disabilities  in personal care in patients with rheumatic disorders .
  The second aim was to investigate which of these instruments have acceptable , method ological quality with regard to reliability , validity and responsiveness .
  The third aim was to investigate the assumption that convergent validity results in stronger correlations when vali date d against a more similar construct .