Patient-reported Measures Of Physical Function Research Articles

Associations between changes in leg extensor muscle power and physical function after supervised exercise in patients with hip osteoarthritis. Secondary analysis from the hip booster trial

ObjectiveTo investigate associations between changes in leg extensor muscle power of the affected limb (ΔLEP) and changes in physical function after 12 weeks of progressive resistance training (PRT) or neuromuscular exercise (NEMEX) in patients with hip osteoarthritis. DesignSecondary analyses of a randomized controlled trial. From 160 participants enrolled in the clinical trial and cluster randomized to PRT (n ​= ​82) or NEMEX (n ​= ​78), a total of 147 (92%) had complete follow-up data and were included in the analyses. Simple linear and multivariate linear regression models estimated the crude and adjusted associations between ΔLEP normalized to body weight (watt/kg) and changes in performance-based and patient-reported measures of physical function. ResultsAdjusted estimates [95% confidence intervals] showed associations between ΔLEP (watt/kg) and changes in 30-s chair stand test (β: 2.34 [1.33; 3.35], R2: 0.13), 9-step timed stair climb test (β: −1.47 [-2.09; −0.85], R2: 0.38), 40-m fast paced walking test (β: −2.20 [-3.30; −1.11], R2: 0.09), Activities of Daily Life function (β: 8.63 [3.16; 14.10], R2: 0.23) and Sport and Recreation function (β: 10.57 [2.32; 18.82], R2: 0.21) subscales from the Hip disability and Osteoarthritis Outcomes Score. Group allocation to PRT did not lead to greater regression coefficients than in NEMEX. ConclusionsChanges in leg extensor muscle power after supervised exercise are consistently associated with changes in physical function across performance-based and patient-reported measures in patients with hip osteoarthritis. These associations seem to be independent of allocation to PRT or NEMEX.

What facets of physical function are most important to adults diagnosed with cancer?

Successful patient-focused drug development involves selecting and measuring outcomes in clinical trials that are important to patients. The U.S. Food & Drug Administration's definition of clinical benefit includes how patients feel, function, or survive. Patients are considered the experts in describing how they feel and function. In cancer trials, patient-reported measures of physical function provide insight into how patients function at baseline, benefit from the interventions being studied, and the impact of treatment side effects. We conducted a qualitative study with adults diagnosed with cancer to describe facets of physical function from their perspective and to identify which facets are most important to this patient population. Using concept elicitation and cognitive interviewing techniques, we conducted semi-structured interviews with 72 adults ≥ 22years of age with cancer who received treatment with an anticancer drug or biologic within six months of the interview. We selected participants using purposive sampling with the aim to elicit diverse experiences regarding how they may interpret and respond to questions related to physical function. Participants were presented with patient-reported outcome (PRO) items representative of PRO measures used in cancer and general populations. Five facets of how physical function relates to activities were defined from the patient perspective: ability, difficulty, limitation, satisfaction, and completion. More than half of the participants indicated that ability was the most important facet of physical function. The next most important were satisfaction (18.3%), limitation (14.1%), difficulty (5.6%), and completion (2.8%). This study demonstrates that we must be more specific about the facets of physical function that we set out to assess when we use PRO measures to describe the patient experience. These results have implications for the specificity of physical function facets when measured in cancer clinical trials.

Improvements in Objective and Patient-Reported Measures of Physical Function Following an 8-Week Exercise Oncology Program

Background: Physical function is often impaired because of cancer and its treatment. Despite this, it is not common to comprehensively assess physical function in clinical practice. The purpose of this study was to examine the changes in objective and patient-reported physical function in adults with a history of cancer who completed an exercise program. Methods: The program was offered 2 d/wk for 8 weeks at an outpatient physical therapy clinic and consisted of resistance and aerobic exercises that were individualized to each participant. Objective physical function was assessed using the Bellarmine Norton Assessment Tool consisting of self-reported physical activity frequency, 2-minute step test, 30-second sit to stand, timed arm curl, Timed Up and Go, and scaled total score. Patient-reported physical function was assessed using the PROMIS-Physical Function (PF) Computerized Adaptive Test (CAT). Results: Significant differences (P < .001) were found for all outcomes demonstrating improvements in objective and patient-reported physical function. Changes in raw and scaled total score for objective physical function displayed large Cohen d effect sizes (ES), physical activity (ES = 0.82), 2-minute step test (ES = 1.00), 30-second sit to stand (ES = 1.01), arm curl (ES = 1.01), Timed Up and Go (ES = 0.85), and scaled total score (ES = 1.31). Changes in PROMIS-PF CAT demonstrated a medium-large effect (ES = 0.78). Conclusion: The effectiveness of the exercise program was supported by significant improvements in objective and patient-reported physical function. The use of such outcomes provides a useful method to understand changes in physical function and supports the development of effective exercise methods for survivors of cancer.

Optimizing the Design of Clinical Trials to Evaluate the Efficacy of Function-Promoting Therapies.

Several candidate molecules that may have application in treating physical limitations associated with aging and chronic diseases are in development. Challenges in the framing of indications, eligibility criteria, and endpoints and the lack of regulatory guidance have hindered the development of function-promoting therapies. Experts from academia, pharmaceutical industry, National Institutes of Health (NIH), and Food and Drug Administration (FDA) discussed optimization of trial design including the framing of indications, eligibility criteria, and endpoints. Mobility disability associated with aging and chronic diseases is an attractive indication because it is recognized by geriatricians as a common condition associated with adverse outcomes, and it can be ascertained reliably. Other conditions associated with functional limitation in older adults include hospitalization for acute illnesses, cancer cachexia, and fall injuries. Efforts are underway to harmonize definitions of sarcopenia and frailty. Eligibility criteria should reconcile the goals of selecting participants with the condition and ensuring generalizability and ease of recruitment. An accurate measure of muscle mass (eg, D3 creatine dilution) could be a good biomarker in early-phase trials. Performance-based and patient-reported measures of physical function are needed to demonstrate whether treatment improves how a person lives, functions, or feels. Multicomponent functional training that integrates training in balance, stability, strength, and functional tasks with cognitive and behavioral strategies may be needed to translate drug-induced muscle mass gains into functional improvements. Collaborations among academic investigators, NIH, FDA, pharmaceutical industry, patients, and professional societies are needed to conduct well-designed trials of function-promoting pharmacological agents with and without multicomponent functional training.

Abstract 10271: Poor Response and Nonresponse to Clinically Available Supervised Exercise Therapy for Peripheral Artery Disease: A Pooled Analysis

Introduction: Nonresponse to supervised exercise therapy (SET) for symptomatic peripheral artery disease (PAD) is a known, but poorly understood, phenomenon affecting approximately one third of individuals. This study evaluated the prevalence and characteristics of poor response and nonresponse among patients with PAD participating in clinically-available SET programs. Methods: Data were pooled from four studies (conducted from 2015-2021) embedded within clinically-available SET programs in the Midwest. SET was 12 weeks in duration and included individualized treadmill walking or other exercise modalities (e.g., total body recumbent stepping, cycling) to moderate ischemia, according to patient ability. In addition to providing demographic and medical information, patients completed the 6-minute walk test (6MWT), Short Physical Performance Battery (SPPB), Walking Impairment Questionnaire (WIQ), and PAD Quality of Life Questionnaire (PADQOL) at baseline and 12 weeks. In post-hoc analyses, we examined the prevalence of nonresponse (including no change [≤0 m] or lack of a clinically meaningful change [≤9 m]) in the 6MWT total distance (primary outcome) and other objective and patient-reported outcomes. Results: A total of 130 patients (85%) completed SET. Mean (SD) age was 72.3 (8.4), BMI 30.2 (6.3), ABI 0.68 (0.23) and 53.1% of patients were male. Despite the overall improvement observed in 6MWT total distance (34.1 [57.1] meters), there was substantial inter-individual variability in changes in 6MWT total distance over 12 weeks, ranging from a 249.9-meter increase to a 104.6-meter decrease. The prevalence of nonresponse (no change/decline in performance) in 6MWT total distance was 24.6%. The prevalence of poor response (lack of a clinically meaningful improvement) was 32.3%. Similar patterns of poor and nonresponse were observed in both objective and patient-reported measures of physical function. Conclusions: The prevalence of nonresponse observed in these clinically available programs is similar to what has been reported in randomized controlled trials. Additional research should examine modifiable predictors of poor and nonresponse to inform programming and maximize an individual’s potential benefit from exercise therapy.

AB0922 Psoriatic Arthritis Disease Activity Differs by Race/Ethnicity

BackgroundPsoriatic arthritis (PsA) affects up to 30% of individuals with psoriasis. Studies have demonstrated that the presenting disease severity and quality of life impact of psoriasis differs by race/ethnicity in patients with and without PsA, but little is known about disease activity among different racial/ethnic groups [1-3].ObjectivesThe objective of our study was to evaluate disease activity by race/ethnicity among patients with PsA.MethodsWe performed a cross-sectional study of adult (≥18 years old) patients with PsA who had at least one outpatient visit within the University of Pennsylvania health system between 2010 and 2019. Patients with PsA were identified by the presence of at least two International Classification of Diseases (ICD)-9 or ICD-10 codes for PsA associated with two different healthcare encounters. The primary outcome was disease activity as measured by the Routine Assessment of Patient Index Data 3 (RAPID3) assessment. The RAPID3 score is a validated patient-reported measure of physical function, pain, and global status [4]. RAPID3 scores range from 0 to 30, with higher scores indicating greater disease activity. Patients were included if they had at least one documented RAPID3 score. For patients with multiple RAPID3 scores, the median value was used. The primary independent variable was race/ethnicity categorized as White (reference), Black, Asian, Hispanic, or other race. Multivariable linear regression was used to assess the relationship between race/ethnicity and RAPID 3 score.ResultsThe study population included 742 patients. Mean (standard deviation [SD]) age was 47.2 (13.3) years and 57.4% were female. The racial/ethnic distribution was 79.4% White, 7.0% Black, 5.0% Asian, 3.1% Hispanic, 2.6% other race, and 3.0% missing race/ethnicity. The means of the median Rapid3 scores were statistically significantly different across racial/ethnic groups (p<.001): White mean (SD) 9.79 (6.02), Black mean (SD) 14.86 (14.86), Asian mean (SD) 9.79 (5.44), Hispanic mean (SD) 15.09 (7.11), other race mean (SD) 10.57 (6.91). In an adjusted multivariable model controlling for other sociodemographic factors, body mass index, treatment history, and medical comorbidity, Hispanic patients had higher RAPID3 scores compared to White patients, indicating greater disease activity (β 3.36; 95% confidence interval [CI] 1.04 – 5.67, p <.005). In exploratory stratified analyses to evaluate effect modification by sex, among males, Black (β 3.43; 95% CI 0.23 – 6.63, p=.04) and Hispanic (β 5.94; 95% CI 2.18 – 9.70, p <.005) patients had higher RAPID3 scores than White patients. Among females, no significant racial/ethnic differences in RAPID3 scores were identified.ConclusionBlack and Hispanic patients report greater disease activity as indicated by higher RAPID3 scores compared to White patients. Larger studies are necessary to confirm our findings and understand the causes of racial/ethnic differences in disease activity among patients with PsA.

Individual Differences in Response to Supervised Exercise Therapy for Peripheral Artery Disease.

Nonresponse to exercise has been extensively examined in young athletes but is seldom reported in studies of aerobic exercise interventions in older adults. This study examined the prevalence of nonresponse and poor response to exercise in functional and quality of life outcomes and response patterns between and among older adults undergoing 12-weeks of supervised exercise therapy for the management of peripheral artery disease (N = 44, mean age 72.3 years, 47.7% female). The prevalence of nonresponse (no change/decline in performance) in walking distance was 31.8%. The prevalence of poor response (lack of a clinically meaningful improvement) was 43.2%. Similar patterns of response were observed in both objective and patient-reported measures of physical function. All participants improved in at least one outcome; only two participants improved in all measured outcomes. Additional research should examine modifiable predictors of response to inform programming and maximize an individual's potential benefit from exercise therapy.

The Trail Making test: a study of its ability to predict falls in the acute neurological in-patient population

Objective: To determine whether tests of cognitive function and patient-reported outcome measures of motor function can be used to create a machine learning-based predictive tool for falls. Design: Prospective cohort study. Setting: Tertiary neurological and neurosurgical center. Subjects: In all, 337 in-patients receiving neurosurgical, neurological, or neurorehabilitation-based care. Main Measures: Binary (Y/N) for falling during the in-patient episode, the Trail Making Test (a measure of attention and executive function) and the Walk-12 (a patient-reported measure of physical function). Results: The principal outcome was a fall during the in-patient stay (n = 54). The Trail test was identified as the best predictor of falls. Moreover, addition of other variables, did not improve the prediction (Wilcoxon signed-rank P < 0.001). Classical linear statistical modeling methods were then compared with more recent machine learning based strategies, for example, random forests, neural networks, support vector machines. The random forest was the best modeling strategy when utilizing just the Trail Making Test data (Wilcoxon signed-rank P < 0.001) with 68% (± 7.7) sensitivity, and 90% (± 2.3) specificity. Conclusion: This study identifies a simple yet powerful machine learning (Random Forest) based predictive model for an in-patient neurological population, utilizing a single neuropsychological test of cognitive function, the Trail Making test.

Capturing a Patient-Reported Measure of Physical Function Through an Online Electronic Health Record Patient Portal in an Ambulatory Clinic: Implementation Study.

BackgroundDespite significant interest in the collection of patient-reported outcomes to make care more patient-centered, few studies have evaluated implementation efforts to collect patient-reported outcomes from diverse patient populationsObjectiveWe assessed the collection of patient-reported outcomes from rheumatoid arthritis patients in an academic rheumatology clinic, using a paper and an online form through the electronic health record patient portal.MethodsWe identified patients seen between 2012-2016 with ≥2 face-to-face encounters with a rheumatology provider and International Classification of Diseases codes for RA, ≥30 days apart. In 2013, our clinic implemented a paper version of the Patient Reported Outcome Measurement Information System (PROMIS) physical function form that was administered to patients upon their check-in at the clinic. In 2015, an online version of the form became available by way of the electronic health record patient portal to patients with active portal accounts. We compared the proportion of visits with documented PROMIS scores across age, race and ethnicity, and language and examined trends over time using a control chart.ResultsWe included 1078 patients with rheumatoid arthritis with 7049 in-person encounters at the rheumatology clinic over 4 years, with an average of 168 visits per month. Of the included patients, 80.4% of patients (867/1078) were female and the mean age was 58 (SD 16) years. The overall PROMIS physical function score documentation increased from 60.4% (1081/1791) of visits in 2013 to 74.4% (905/1217) of visits in 2016. Online score documentation increased from 10.0% (148/1473) in 2015 to 19.3% (235/1217) in 2016. African American patients were least likely to have a PROMIS physical function score recorded (55/88, 62.5% compared to 792/990, 80.0% for other racial or ethnic groups; P<.001). Compared with white patients, both African American and Hispanic patients were less likely to have active online electronic health record portal accounts (44/88, 50% and 90/157, 57.3% respectively, compared to 437/521, 83.9% of white patients; P<.001) and, once activated, less likely to use the online survey (6/44, 13.6% and 16/90, 17.8% respectively, compared to 135/437, 30.9% of white patients; P=.02). There was no significant difference in the proportion of any PROMIS physical function forms recorded between non-English vs English preferred patients. No significant differences were found across age or gender.ConclusionsPROMIS physical function form completion improved overall from 2012-2016 but lagged among racial and ethnic minorities and non-English preferred patients. Future studies should address issues of portal access, enrollment, satisfaction, and persistence and focus on developing PRO implementation strategies that accommodate the needs and preferences of diverse populations.

Patient-Reported Physical Function Measures in Cancer Clinical Trials.

Patient-reported outcomes (PROs) are increasingly used to monitor treatment-related symptoms and physical function decrements in cancer clinical trials. As more patients enter survivorship, it is important to capture PRO physical function throughout trials to help restore pretreatment levels of function. We completed a systematic review of PRO physical function measures used in cancer clinical trials and evaluated their psychometric properties on the basis of guidelines from the US Food and Drug Administration. Five databases were searched through October 2015: PubMed/MEDLINE, EMBASE, CINAHL (Cumulative Index of Nursing and Allied Health Literature), Health and Psychosocial Instruments, and Cochrane. From an initial total of 10,233 articles, we identified 108 trials that captured PRO physical function. Within these trials, approximately 67% used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and 25% used the Medical Outcomes Study Short Form 36. Both the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and Medical Outcomes Study Short Form 36 instruments generically satisfy most Food and Drug Administration requirements, although neither sought direct patient input as part of item development. The newer Patient-Reported Outcomes Measurement Information System physical function short form may be a brief, viable alternative. Clinicians should carefully consider the psychometric properties of these measures when incorporating PRO instrumentation into clinical trial design to provide a more comprehensive understanding of patient function.

Patient-Reported Measures of Physical Function in Knee Osteoarthritis.

Knee osteoarthritis is a common cause of an array of functional limitations in older adults, and the accurate assessment of such limitations is critical for practicing clinicians and scientists. Patient-reported measures are a valuable resource to track the type and severity of limitation, although the psychometric performance of each instrument should be thoroughly evaluated before adoption. This article reviews the validity, reliability, sensitivity to change, and responsiveness of 3 patient-reported measures of physical function: the Western Ontario and McMaster Universities Osteoarthritis Index, the Knee Injury and Osteoarthritis Outcome Score, and the Patient Reported Outcomes Measurement Information System Physical Function scale.

Hip Abductor Strength Reliability and Association With Physical Function After Unilateral Total Knee Arthroplasty: A Cross-Sectional Study

Because people with total knee arthroplasty (TKA) have persistent functional limitations and disability, identifying modifiable risk factors for persistent disability is warranted. Before surgery, people have pervasive lower extremity muscle weakness. The fact that hip abductor muscle strength is often not targeted in postoperative rehabilitation may contribute to functional limitations. Study objectives were: (1) to examine the reliability of handheld dynamometry (HHD) for measuring hip abductor strength and (2) to determine whether hip abductor strength contributes to physical function beyond the contribution of quadriceps muscle strength. This was a cross-sectional study. Two-hundred ten participants underwent quadriceps and hip abductor muscle strength testing and measurement of physical function (performance-based and self-reported outcomes). Correlation and regression equations were built to determine the relationships of strength, pain, and functional ability. A subset of 16 participants underwent hip abductor strength testing at 2 sessions to determine the reliability of the measure. Measuring hip abductor strength with HHD yielded excellent relative reliability, with an intraclass correlation coefficient (ICC [2,3]) of .95 and a 95% confidence interval of .86 to .98, but moderate absolute reliability, with a minimal detectable change (with 95% confidence) of 47.6 N and a 95% confidence interval of 35.5 to 76.5. Hip abductor strength made a significant additional contribution to performance-based measures of physical function after anthropometric covariates and quadriceps muscle strength were accounted for. Hip abductor strength did not show bivariate correlations with patient-reported measures of physical function and did not contribute to patient-reported physical function after covariates and quadriceps muscle strength were accounted for. A cause-and-effect relationship between hip abductor strength and physical function could not be established. In people with unilateral TKA, HHD testing of hip abductor strength is reliable. Hip abductor strength contributes to performance-based but not patient-reported measures of physical function in people with unilateral TKA.

Performance-Based Versus Patient-Reported Physical Function: What Are the Underlying Predictors?

Functional limitations have been operationally defined for studies of rehabilitation science through measures of physical performance and patient-reported function. Although conceived as representing similar concepts, differences between these 2 modes of measuring physical functioning have not been adequately characterized scientifically. The purpose of this study was to compare the Short Physical Performance Battery (SPPB) with the function component of the Late-Life Function and Disability Instrument (LLFDI) with respect to their association with physiologic factors and other psychosocial and health factors potentially influencing rehabilitative care. This study was a cross-sectional analysis of baseline data from a sample of community-dwelling older adults (N=137) with mobility limitations enrolled in a randomized controlled trial of exercise. A performance-based measure of function (the SPPB) and a self-report measure of function (the LLFDI) served as functional outcomes. Physiologic factors included measures of leg strength, leg velocity, and exercise tolerance test (ETT) duration, which served as a surrogate measure of aerobic capacity. Psychosocial and health factors included age, sex, height, body mass index, number of chronic conditions, depression, and falls efficacy. Separate multivariable regression models predicting SPPB and LLFDI scores described 33% and 42% of the variance in each outcome (R(2)), respectively. Leg velocity and ETT duration were positively associated with both performance-based and patient-reported functional measures. Leg strength and age were positively associated with SPPB scores, whereas number of chronic conditions, sex, and falls efficacy were associated with the LLFDI scores. This study included older adults with mobility limitations and may not generalize to other populations. Performance-based and patient-reported measures of physical function appear to assess different aspects of an older person's functioning. The SPPB was associated with age and physiologic factors, whereas patient-reported function measured by the LLFDI was associated with these factors as well as with psychosocial and health factors.

Dialysis patients treated with Epoetin α show improved exercise tolerance and physical function: A new analysis of the Canadian Erythropoietin Study Group trial

The risks/benefits of anemia treatment in dialysis patients have been redefined in the US Epoetin α label. This analysis was carried out to determine if increasing hemoglobin (Hb) levels improve exercise tolerance and physical function in anemic dialysis patients. This is a new analysis of the Canadian Erythropoietin Study Group trial, a double-blind, randomized, placebo-controlled trial in dialysis patients. Subjects were 18 to 75 years old, on hemodialysis for >3 months, and had a baseline Hb <9.0 g/dL. Patients with a history of diabetes mellitus, ischemic heart disease, or severe/uncontrolled hypertension were excluded. Patients were randomized to receive Epoetin α to a target Hb of 9.5 to 11.0 g/dL (n=40) or a target of 11.5 to 13.0 g/dL (n=38), or receive placebo (n=40). Results from patients in the Epoetin-α-treated arms were combined for this analysis. Hb level, exercise tolerance (Treadmill Stress Test and 6-Minute Walk Test) and patient-reported physical function measures (Physical Summary domain from the Kidney Disease Questionnaire, and 4 domains from the Sickness Impact Profile) were reported at baseline and months 2, 4, and 6. Differences in measures were statistically significant for exercise tolerance (Treadmill Stress, P=0.0001) and patient-reported physical function (Kidney Disease Questionnaire Physical, P=0.0001; Sickness Impact Profile Physical, P=0.0015) across all time points for Epoetin-α-treated patients compared with placebo. Improvements were seen at 2 months and were maintained through months 4 and 6. Dialysis patients receiving Epoetin α showed improved exercise tolerance and physical function. These findings should be considered as physicians weigh the risks and benefits of treatment.

Interrater Reliability and Validity of the Stair Ascend/Descend Test in Subjects With Total Knee Arthroplasty

Almeida GJ, Schroeder CA, Gil AB, Fitzgerald GK, Piva SR. Interrater reliability and validity of the stair ascend/descend test in subjects with total knee arthroplasty. Objective (1) To determine the interrater reliability and measurement error of an 11-step stair ascend/descend test (STTotal-11) and stair up (ascend) test (STUp-11); (2) to seek evidence for the STTotal-11 and STUp-11 as valid measures of physical function by determining if they relate to measures of physical function and do not relate to measures not of physical function; and (3) to explore if the STTotal-11 and STUp-11 scores relate to lower-extremity muscle weakness and knee range of motion (ROM) in subjects with total knee arthroplasty (TKA). Design Cross-sectional study. Setting Academic center. Participants Subjects (N=43, 30 women; mean age, 68±8y) with unilateral TKA. Interventions Not applicable. Main Outcome Measures STTotal-11 and STUp-11 were performed twice, and scores were compared with scores on 4 lower extremity performance-based tasks, 2 patient-reported questionnaires of physical function, 3 psychologic factors, knee ROM, and strength of quadriceps, hip extensors, and abductors. Results Intraclass correlation coefficient was .94 for both the STTotal-11 and STUp-11, standard error of measurements were 1.14 seconds and .82 seconds, and minimum detectable change associated with 90% confidence interval was 2.6 seconds and 1.9 seconds, respectively. Correlations between stair tests and performance-based measures and knee and hip muscle strength ranged from Pearson correlation coefficient ( r)=.40 to .78. STTotal-11 and STUp-11 had a small correlation with one of the patient-reported measures of physical function. Stair tests were not associated with psychologic factors and knee extension ROM and were associated with knee flexion ROM. Conclusions STTotal-11 and STUp-11 have good interrater reliability and minimum detectable changes adequate for clinical use. The pattern of associations supports the validity of the stair tests in TKA.

Monitoring disease activity of rheumatoid arthritis in clinical practice: contributions from clinical trials

Rheumatoid arthritis is a heterogeneous and progressive autoimmune disease, and patients with this condition show varied responses to treatment. Practical, reliable, individually tailored measures of disease activity and treatment responses are needed. Outcome measures used in randomized, controlled trials, including American College of Rheumatology response criteria and Disease Activity Scores, identify when treatment should be initiated or changed, but can be time consuming and impractical in daily practice. Simplified disease activity indices, abbreviated joint counts and patient-report questionnaires are more-convenient ways to assess therapeutic responses in the clinic. Patient-reported measures of physical function, pain and global disease activity best differentiate the results of active treatment from those of placebo treatment in randomized, controlled trials. Improvements in physical function closely reflect changes in health-related quality of life. Recent trials have demonstrated limited correlations between clinical responses and radiographically demonstrated responses; both should be assessed on a regular basis. It is recommended that three domains be assessed in the clinic for therapeutic responses: patient-reported measures of physical function and/or global disease activity; physician assessment of disease activity; and imaging of the hands and/or feet on a biannual basis. Problematic joints and cervical spine involvement should be followed as clinically indicated. Measures of improvement for individually relevant physical activities need to be defined for each patient.