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Purpose Upper respiratory tract infections (URTI) and related symptoms are widespread and a common reason for visiting primary care with cough and sore throat being most prevalent. Despite their impact on daily activities, no studies have explored the impact on health-related quality of life (HRQOL) in representative general populations. We aimed to understand the short-term impact of the two most prevalent URTI symptoms on HRQOL. Methods Online 2020 surveys including acute (≤ 4 weeks) respiratory symptoms (sore throat and cough) and SF-36® health survey (all with 4-week recall) were analysed using analysis of covariance (ANCOVA) in comparison with adult US population norms. Linear T-score transformation of SF-6D utility (ranging from 0 to 1) enabled direct comparisons with SF-36. Results In total, 7563 US adults responded (average age: 52 years; range: 18–100 years). Sore throat and cough lasting at least several days were experienced by 14% and 22% participants, respectively. Chronic respiratory conditions were reported by 22% of the sample. A clear and consistent pattern of group HRQOL means declining significantly (p Conclusion Declines in HRQOL with acute cough and sore throat symptoms consistently exceeded MID standards and should not be ignored as self-limiting without intervention. Future studies on early self-care for symptom relief and its implications on HRQOL and health economics would be valuable to understand the benefits on healthcare burden and need for updating treatment guidelines.

PURPOSE: Adults with autism spectrum disorder (ASD) consistently report worse functional health and well-being, compared to neurotypical (NT) peers. In a series of studies, we aimed to elucidated the effects of sex, age, and their interaction on health-related quality of life (HRQoL) and evaluated the effectiveness of mindfulness-based stress reduction (MBSR) for improving health-, disability-, and autism-related QoL, with possible sex and age outcome moderators, in adults with ASD. METHODS: Study 1 used the 36-Item Short Form Survey to compare mental and physical HRQoL composite scores in adults with ASD (n = 67) and matched NT adults (n = 66). Study 2 was a randomized pilot evaluation of the effect of MBSR, compared to an active control intervention with social support and relaxation education (support/education; n = 56), on the World Health Organization QoL BREF, Disability, and Autism-Specific scales in adults with ASD. RESULTS: In Study 1, we replicated findings that mental HRQoL is worse in both men and women with ASD, compared to NT counterparts, but physical HRQoL is only worse in women with ASD. We present novel findings that older age is associated with better mental HRQoL in women with ASD only. In Study 2, MBSR improved disability-related QoL in adults with ASD over and above the support/education intervention, but both interventions improved mental HRQoL. Lastly, both interventions were more effective for HRQoL improvements in women with ASD. CONCLUSION: Findings encourage precision medicine approaches tailored to age and sex groups for best HRQoL outcomes in adults with ASD. CLINICALTRIALS.GOV IDENTIFIER: NCT04017793.

Background Interpretation of health-related quality of life (QOL) outcomes requires improved methods to control for the effects of multiple chronic conditions (MCC). This study systematically compared legacy and improved method effects of aggregating MCC on the accuracy of predictions of QOL outcomes. Methods Online surveys administered generic physical (PCS) and mental (MCS) QOL outcome measures, the Charlson Comorbidity Index (CCI), an expanded chronic condition checklist (CCC), and individualized QOL Disease-specific Impact Scale (QDIS) ratings in a developmental sample (N = 5490) of US adults. Controlling for sociodemographic variables, regression models compared 12- and 35-condition checklists, mortality vs. population QOL-weighting, and population vs. individualized QOL weighting methods. Analyses were cross-validated in an independent sample (N = 1220) representing the adult general population. Models compared estimates of variance explained (adjusted R2) and model fit (AIC) for generic PCS and MCS across aggregation methods at baseline and nine-month follow-up. Results In comparison with sociodemographic-only regression models (MCS R2 = 0.08, PCS = 0.09) and Charlson CCI models (MCS R2 = 0.12, PCS = 0.16), increased variance was accounted for using the 35-item CCC (MCS R2 = 0.22, PCS = 0.31), population MCS/PCS QOL weighting (R2 = 0.31–0.38, respectively) and individualized QDIS weighting (R2 = 0.33 & 0.42). Model R2 and fit were replicated upon cross-validation. Conclusions Physical and mental outcomes were more accurately predicted using an expanded MCC checklist, population QOL rather than mortality CCI weighting, and individualized rather than population QOL weighting for each reported condition. The 3-min combination of CCC and QDIS ratings (QDIS-MCC) warrant further testing for purposes of predicting and interpreting QOL outcomes affected by MCC.

Background Patient-reported outcome measures that are more practical and clinically useful are needed for patients with CKD. We compared a new CKD-specific quality-of-life impact scale (CKD-QOL) with currently used measures. Methods Patients ( n =485) in different treatment groups (nondialysis stages 3–5, on dialysis, or post-transplant) completed the kidney-specific CKD-QOL and Kidney Disease Quality of Life-36 (KDQOL-36) forms and the generic SF-12 Health Survey at baseline and 3 months. New items summarizing quality of life (QOL) impact attributed to CKD across six QOL domains yielded single impact scores from a six-item static (fixed-length) form and from computerized adaptive tests (CATs) with three to six items. Validity tests compared the CKD-QOL, KDQOL-36 (Burden, Effects, and Symptoms/Problems subscales), and generic SF-12 measures across groups in four tests of clinical status and clinician assessment of change (CKD-specific tests), and number of comorbidities. ANOVA was used to test for group mean differences, variances in each measure explained by groups, and relative validity (RV) in comparison with the referent KDQOL-36 Burden subscale. Results KDQOL-36 and CKD-QOL measures generally discriminated better than generic SF-12v2 measures. The pattern of variances across CKD-specific tests comparing validity favored CKD-QOL two-fold over KDQOL-36. Two RV test results confirmed CKD-QOL improvements over the referent KDQOL scale. Results for static and CAT CKD-QOL forms were similar. SF-12 Physical and KDQOL-36 Symptoms scores worsened with increasing comorbid condition counts. Conclusions Overall, compared with the KDQOL-36, the new approach to summarizing CKD-specific QOL impact performed better across multiple tests of validity. CAT surveys were more efficient than static surveys.

The objective of this study was to develop the classification system for version of the SF-6D (SF-6Dv2) from the SF-36v2. SF-6Dv2 is an improved version of SF-6D, one of the most widely used generic measures of health for the calculation of quality-adjusted life years.A 3-step process was undertaken to generate a new classification system: (1) factor analysis to establish dimensionality; (2) Rasch analysis to understand item performance; and (3) tests of differential item function. To evaluate robustness, Rasch analyses were performed in multiple subsets of 2 large cross-sectional datasets from recently discharged hospital patients and online patient samples.On the basis of factor analysis, other psychometric evidence, cross-cultural considerations, and amenability to valuation, the 6-dimension classification used in SF-6D was maintained. SF-6Dv2 resulted in the following modifications to SF-6D: a simpler classification of physical function with clearer separation between levels; a more detailed 5-level description of role limitations; using negative wording to describe vitality; and using pain severity rather than pain interference.The SF-6Dv2 classification system describes more distinct levels of health than SF-6D, changes the descriptions used for a number of dimensions and provides clearer wording for health state valuation. The second stage of the study has developed a utility value set using discrete choice methods so that the measure can be used in health technology assessment. Further work should investigate the psychometric characteristics of the new instrument.

ObjectiveTo develop a tool for estimating the 10-year risk of death from other causes in men with localized prostate cancer.Subjects and methodsWe identified 2,425 patients from the Surveillance Epidemiology and End Results—Medicare Health Outcomes Survey database, age ResultsOver a median follow-up of 7.7 years, 76 men died of prostate-specific causes and 465 died of other causes. The strongest predictors of 10-year other cause mortality risk included increasing age at diagnosis, higher approximated Charlson Comorbidity Index score, worse patient-reported general health (fair or poor vs. excellent-good), smoking at diagnosis, and marital status (all other vs. married) (all pConclusionsWe provide a tool for estimating the 10-year risk of dying from other causes when making decisions about treating prostate cancer using pre-treatment patient-reported characteristics.

Objective: \ud The objective of this study was to develop the classification system for version of the SF-6D (SF-6Dv2) from the SF-36v2. SF-6Dv2 is an improved version of SF-6D, one of the most widely used generic measures of health for the calculation of quality-adjusted life years.\ud \ud Study Design and Setting: \ud A 3-step process was undertaken to generate a new classification system: (1) factor analysis to establish dimensionality; (2) Rasch analysis to understand item performance; and (3) tests of differential item function. To evaluate robustness, Rasch analyses were performed in multiple subsets of 2 large cross-sectional datasets from recently discharged hospital patients and online patient samples.\ud \ud Results: \ud On the basis of factor analysis, other psychometric evidence, cross-cultural considerations, and amenability to valuation, the 6-dimension classification used in SF-6D was maintained. SF-6Dv2 resulted in the following modifications to SF-6D: a simpler classification of physical function with clearer separation between levels; a more detailed 5-level description of role limitations; using negative wording to describe vitality; and using pain severity rather than pain interference.\ud \ud Conclusions: \ud The SF-6Dv2 classification system describes more distinct levels of health than SF-6D, changes the descriptions used for a number of dimensions and provides clearer wording for health state valuation. The second stage of the study has developed a utility value set using discrete choice methods so that the measure can be used in health technology assessment. Further work should investigate the psychometric characteristics of the new instrument.

Objective To evaluate validity and responsiveness of the Knee Injury and Osteoarthritis Outcome Score (KOOS) in relation to other patient-reported outcome measures before and after total knee replacement (TKR). Methods Pre-TKR and 6-month post-TKR data from 1,143 patients in a US joint replacement cohort were used to compare the KOOS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the SF-36 Health Survey (SF-36). Validity was evaluated with multiple methods, including correlations of pre-TKR scale scores and analysis of variance models that used pre-TKR data to compare the relative validity of scales in discriminating between groups differing in assistive walking device use and number of comorbid conditions. Validity was also evaluated by using post-TKR minus pre-TKR change scores to assess relative validity of scales in discriminating between groups rating themselves as better, same, or worse (BSW) in their capability to do activities at 6 months. Responsiveness also was described using effect sizes and standardized response means. Results In support of convergent and discriminant validity, KOOS scale scores were worse for patients using an assistive device but only declined weakly with increasing comorbid conditions. While all knee-specific scales discriminated between BSW groups, the KOOS quality of life (QOL) scale was significantly better (P

Summary Objective To evaluate reliability, validity and responsiveness of KOOS-12, a 12-item short form of the 42-item Knee injury and Osteoarthritis Outcome Score (KOOS) that provides Pain, Function and Quality of Life (QOL) scale scores and a summary knee impact score. Design Data from 1,392 knee osteoarthritis (OA) patients from the FORCE-TJR research cohort who completed KOOS before and 6 and 12 months after total knee replacement (TKR) were analyzed. KOOS-12 includes a pain frequency item and three items measuring pain during increasingly difficult (sitting/lying, walking, stairs) activities; function items about standing, rising from sitting, getting in/out of a car, and twisting/pivoting; and the 4-item KOOS QOL scale. Percent computable scale scores, floor and ceiling effects, internal consistency reliability, validity (scale correlations, tests of known groups validity using one-way analysis of variance (ANOVA)) and responsiveness (effect sizes, standardized response means) were compared for the KOOS-12, full-length KOOS, KOOS-PS and KOOS, JR. Results Internal consistency reliability was above 0.70 for all KOOS-12 scales and ≥0.90 for the KOOS-12 Summary score. Validity and responsiveness of KOOS-12 Pain, Function and QOL scales was satisfactory and reached similar conclusions as comparable full-length KOOS scales. The KOOS-12 Summary score was most responsive in discriminating between groups who differed in global ratings of post-TKR change in physical capabilities and had the highest effect sizes and standardized response means. Conclusions KOOS-12 was a reliable and valid alternative to KOOS in TKR patients with moderate to severe OA and provided three domain-specific and summary knee impact scores with substantially reduced respondent burden.

Background : A crucial assumption underlying all disease-specific quality of life (QOL) measures, that patients can validly differentiate a specific disease in the presence of multiple chronic conditions , has not been tested using multiple methods. Our objective was to evaluate the convergent and discriminant validity of QOL attributions to specific diseases among adults with multiple chronic conditions (MCC). Methods : Adults age 18 and older (N=4,480) sampled from eight pre-identified condition groups (asthma, COPD, angina/MI with angina, congestive heart failure, diabetes, chronic kidney disease, osteoarthritis, rheumatoid arthritis) completed an Internet survey. Comorbid conditions were determined using a 35-condition checklist. Product-moment correlations were analyzed separately by pre-identified condition group using the multitrait-multimethod of construct validation, where traits were defined by 9-26 conditions and each condition was measured by two methods: disease severity rating and Disease-specific Quality of Life Impact Scale (QDIS) global rating. A third method (symptom or clinical marker) was available for the eight pre-identified conditions. Convergent validity was supported when correlations among different methods of measuring the same condition (trait) were substantial (r≥ 0.40). Discriminant validity was supported when correlations between the same and different methods of measuring different conditions were significantly lower than corresponding convergent correlations. Results : In support of convergent validity, 22 of 24 convergent correlations were substantial (r=0.38-0.84, median=0.53). In support of discriminant validity, 833 of 924 tests (90.2%) yielded significantly higher convergent than discriminant correlations across the eight pre-identified conditions. Exceptions to this pattern of results were most often observed for comorbid conditions within the same clinical area. Conclusions : Collectively, convergent and discriminant test results support the construct validity of disease-specific QOL impact attributions across MCC within the eight pre-identified conditions. Noteworthy exceptions should be considered when interpreting some specific QOL impact attributions and warrant further study. Pursuit of a summary disease-specific QOL impact score standardized across MCC is recommended.

OBJECTIVE: To develop 12-item short forms (KOOS-12, Hip disability and Osteoarthritis Outcome Score (HOOS)-12) of the 42-item Knee injury and Osteoarthritis Outcome Score (KOOS) and 40-item HOOS that represent the full-length instruments sufficiently to provide joint-specific pain, function and quality of life (QOL) domain and summary joint impact scores. This paper describes KOOS-12 and HOOS-12 item selection. Subsequent papers will examine KOOS-12 and HOOS-12 reliability, validity and responsiveness.DESIGN: Items were selected based on qualitative information from patients, clinicians and KOOS/HOOS translators and analysis of data from 1,395 knee osteoarthritis (OA) and 1,281 hip OA patients from the FORCE-TJR cohort who completed KOOS or HOOS before and after total joint replacement (TJR). Item response theory models and computerized adaptive test (CAT) simulations were used to identify items that best measured patients' levels of pain and function pre- and post-TJR. KOOS-12/HOOS-12 items were selected based on content, coverage of a wide measurement range, high item information, item usage in computerized adaptive testing (CAT) simulations, scale-level properties (reliability, validity, responsiveness), and qualitative information.RESULTS: KOOS-12 and HOOS-12 each included a pain frequency item and three items measuring pain during increasingly difficult activities (sitting/lying, walking, up/down stairs); function items about standing, rising from sitting, getting in/out of a car, and twisting/pivoting (KOOS-12) or walking on an uneven surface (HOOS-12); and the original 4-item QOL scale.CONCLUSIONS: This study demonstrated the benefits of examining patient-reported outcome measures using modern psychometric methods, to create short forms with diverse content that provide domain-specific and summary joint impact scores.

Background: Assessment of health-related quality of life (HRQoL) is well established in clinical research, but ceiling effects in validated tools might prevent detection of changes in well respondents. Tobacco Quality of Life Impact Tool (TQOLITv1) uses conceptual and psychometric advances to enhance detection of HRQoL changes. Methods: In a 6-month, forced-switch study, the German TQOLITv1 was assessed in healthy adult (age 23–55 years) current and matched former-smokers. At baseline, smokers were switched to reduced toxicant prototype (RTP) or conventional cigarette for 6 months. TQOLITv1 responses were collected at baseline, 3 and 6 months from current smokers whilst former smokers completed it at the latter two time points. TQOLITv1 includes SF-36v2 and new smoking-specific, physical and general-health measures. Results: Reliability at baseline was good (Cronbach’s coefficient alpha > 0.70) for all measures. The baseline percentage with the best possible score (ceiling effect) for former and current smokers was substantially better for the new physical function than SF-36 physical function measure (35% vs. 59% at ceiling, respectively). New smoking-specific measures discriminated current from former smokers better than general health measures. Smoking-specific symptoms ( r = 0.73) were more stable from baseline to 6 months than other measures (r = 0.38–0.54) particularly more than the SF-36 mental component score (r = 0.24). Although both product smoking groups worsened in most HRQoL measures, changes in general and smoking-specific HRQoL impact measures favored RTP smokers. Conclusions: The German TQOLITv1 is sufficiently reliable and valid to assess HRQoL and may be more useful than SF-36v2 in evaluation of interventions in well smoking populations including those consuming RTPs.

Objectives To test the impact of the method of administration (MOA) on score level, reliability, and validity of scales developed in the Patient Reported Outcomes Measurement Information System (PROMIS). Study Design and Setting Two nonoverlapping parallel forms each containing eight items from each of three PROMIS item banks (Physical Function, Fatigue, and Depression) were completed by 923 adults with chronic obstructive pulmonary disease, depression, or rheumatoid arthritis. In a randomized crossover design, subjects answered one form by interactive voice response (IVR) technology, paper questionnaire (PQ), personal digital assistant (PDA), or personal computer (PC) and a second form by PC, in the same administration. Method equivalence was evaluated through analyses of difference scores, intraclass correlations (ICCs), and convergent/discriminant validity. Results In difference score analyses, no significant mode differences were found and all confidence intervals were within the prespecified minimal important difference of 0.2 standard deviation. Parallel-forms reliabilities were very high (ICC = 0.85–0.93). Only one across-mode ICC was significantly lower than the same-mode ICC. Tests of validity showed no differential effect by MOA. Participants preferred screen interface over PQ and IVR. Conclusion We found no statistically or clinically significant differences in score levels or psychometric properties of IVR, PQ, or PDA administration compared with PC.

Background To document the development and evaluation of the Quality of life Disease Impact Scale (QDIS®), a measure that standardizes item content and scoring across chronic conditions and provides a summary, norm-based QOL impact score for each disease. Methods A bank of 49 disease impact items was constructed from previously-used descriptions of health impact to represent ten frequently-measured quality of life (QOL) content areas and operational definitions successfully utilized in generic QOL surveys. In contrast to health in general, all items were administered with attribution to a specific disease (osteoarthritis, rheumatoid arthritis, angina, myocardial infarction, congestive heart failure, chronic kidney disease (CKD), diabetes, asthma, or COPD). Responses from 5418 adults were analyzed as five disease groups: arthritis, cardiovascular, CKD, diabetes, and respiratory. Unidimensionality, item parameter and scale-level invariance, reliability, validity and responsiveness to change during 9-month follow-up were evaluated by disease group and for all groups combined using multi-group confirmatory factor analysis (MGCFA), item response theory (IRT) and analysis of variance methods. QDIS was normed in an independent chronically ill US population sample (N = 4120). Results MGCFA confirmed a 1-factor model, justifying a summary score estimated using equal parameters for each item across disease groups. In support of standardized IRT-based scoring, correlations were very high between disease-specific and standardized IRT item slopes (r = 0.88–0.96), thresholds (r = 0.93–0.99) and person-level scores (r ≥ 0.99). Internal consistency, test-retest and person-level IRT reliability were consistently satisfactory across groups. In support of interpreting QDIS as a disease-specific measure, in comparison with generic measures, QDIS consistently discriminated markedly better across disease severity levels, correlated higher with other disease-specific measures in cross-sectional tests, and was more responsive in comparisons of groups with better, same or worse evaluations of disease-specific outcomes at the 9-month follow-up. Conclusions Standardization of content and scoring across diseases was shown to be justified psychometrically and enabled the first summary measure of disease-specific QOL impact normed in the chronically ill population. This disease-specific approach substantially improves discriminant validity and responsiveness over generic measures and provides a basis for better understanding the relative QOL impact of multiple chronic conditions in research and clinical practice. Electronic supplementary material The online version of this article (doi:10.1186/s12955-016-0483-x) contains supplementary material, which is available to authorized users.

Research addressing the effect of finasteride, an inhibitor of 5α-reductase (the enzyme that converts testosterone to dihydrotestosterone), on health-related quality of life has been conducted primarily in the context of two medical conditions: benign prostatic hyperplasia and alopecia. Three studies that addressed the effects of finasteride on benign prostatic hyperplasia (1–3) were generally well-powered, with a measurement focus on disease-specific symptoms; improvement associated with finasteride was observed for disease-specific symptoms (except for sexual function) and impact on daily activities or bother items. Less change was observed in these studies for more general measures of health-related quality of life, such as global health-related quality of life, life satisfaction, and worry or concern. Two small studies addressed the impact of finasteride on depression among patients treated for alopecia: one study reported moderate to severe depression or mood disturbance in 19 of 23 patients (4); the other, a single-arm study with 144 patients, reported a statistically significant increase in two measures of depression (ie, more depression) 2 months after treatment with finasteride (5). However, the results of the alopecia studies were preliminary and require confirmation in more patients. The Prostate Cancer Prevention Trial (PCPT) was a 7-year double-blind, placebo-controlled randomized trial of finasteride as a preventive agent for prostate cancer (6–9). There was a 24.8% reduction in the prevalence of prostate cancer over the 7-year trial duration associated with finasteride treatment (9). In that initial report (9), finasteride was associated with increased sexual dysfunction; however, a subsequent publication demonstrated that the level of sexual dysfunction was minimal and decreased over time (10). Given the sparse data regarding long-term finasteride use and health-related quality of life, we felt that it was important to monitor this outcome in the PCPT. We have previously reported the baseline health-related quality of life of men who entered the PCPT (11) and on changes in sexual functioning according to PCPT study arm assignment (10). In this report, we examine the effect of finasteride treatment on health-related quality of life, with particular focus on physical function results, over the course of the 7-year study. In this article, we refer to the physical function domain as measured by the Physical Functioning scale.

To evaluate the validity and participants' acceptance of an online assessment of role function using computer adaptive test (RF-CAT).The RF-CAT and a set of established quality of life instruments were administered in a cross-sectional study in a panel sample (n = 444) recruited from the general population with over-selection of participants with selected self-report chronic conditions (n = 225). The efficiency, score accuracy, validity, and acceptability of the RF-CAT were evaluated and compared to existing measures.The RF-CAT with a stopping rule of six items with content balancing used 25 of the available bank items and was completed on average in 66 s. RF-CAT and the legacy tools scores were highly correlated (.64-.84) and successfully discriminated across known groups. The RF-CAT produced a more precise assessment over a wider range than the SF-36 Role Physical scale. Patients' evaluations of the RF-CAT system were positive overall, with no differences in ratings observed between the CAT and static assessments.The RF-CAT was feasible, more precise than the static SF-36 RP and equally acceptable to participants as legacy measures. In empirical tests of validity, the better performance of the CAT was not uniformly statistically significant. Further research exploring the relationship between gained precision and discriminant power of the CAT assessment is needed.

Role functioning (RF) is a key component of health and well-being and an important outcome in health research. The aim of this study was to develop an item bank to measure impact of health on role functioning.A set of different instruments including 75 newly developed items asking about the impact of health on role functioning was completed by 2,500 participants. Established item response theory methods were used to develop an item bank based on the generalized partial credit model. Comparison of group mean bank scores of participants with different self-reported general health status and chronic conditions was used to test the external validity of the bank.After excluding items that did not meet established requirements, the final item bank consisted of a total of 64 items covering three areas of role functioning (family, social, and occupational). Slopes in the bank ranged between .93 and 4.37; the mean threshold range was -1.09 to -2.25. Item bank-based scores were significantly different for participants with and without chronic conditions and with different levels of self-reported general health.An item bank assessing health impact on RF across three content areas has been successfully developed. The bank can be used for development of short forms or computerized adaptive tests to be applied in the assessment of role functioning as one of the common denominators across applications of generic health assessment.

Objective The two-component factor structure underlying Short Form-36 (SF-36) summary scores may not be valid worldwide. We studied a three-component model of SF-36 scores in Japan. Study Design and Setting The SF-36 scores came from representative samples of the population of Japan. Factor analysis and structural equation modeling were used. The two-component model gave physical component summary (PCS) scores and mental component summary (MCS) scores. The three-component model gave scores on the PCS, the MCS, and also on the third component, which we call the role component summary (RCS) score. These were evaluated with external criteria. Results In the three-component model, the RCS was strongly associated with the role-physical, social functioning, and role-emotional subscales, whereas the PCS and MCS were associated with the physical functioning and mental health subscales, as expected. The goodness-of-fit index was 0.945 for the three-component model and 0.935 for the two-component model. The PCS discriminated between groups stratified by comorbid conditions, and the MCS discriminated between groups stratified by psychological depression. Absence from work was associated with both PCS and RCS. Conclusion The three-component model is better than the two-component model, and it provides more useful PCS and MCS scores. Criteria for validation testing of the RCS are needed.

Role functioning (RF) is an important part of health-related quality of life, but is hard to measure due to the wide definition of roles and fluctuations in role participation. This study aims to explore the dimensionality of a newly developed item bank assessing the impact of health on RF.A battery of measures with skip patterns including the new RF bank was completed by 2,500 participants answering only questions on social roles relevant to them. Confirmatory factor analyses were conducted for the participants answering items from all conceptual domains (N = 1193). Conceptually based dimensionality and method effects reflecting positively and negatively worded items were explored in a series of models.A bi-factor model (CFI = .93, RMSEA = .08) with one general and four conceptual factors (social, family, occupation, generic) was retained. Positively worded items were excluded from the final solution due to misfit. While a single factor model with methods factors had a poor fit (CFI = .88, RMSEA = .13), high loadings on the general factor in the bi-factor model suggest that the RF bank is sufficiently unidimensional for IRT analysis.The bank demonstrated sufficient unidimensionality for IRT-based calibration of all the items on a common metric and development of a computerized adaptive test.

Objective: The Patient-Reported Outcomes Measurement Information System (PROMIS) was initiated to improve precision, reduce respondent burden, and enhance the comparability of health outcomes measures. We used item response theory (IRT) to construct and evaluate a preliminary item bank for physical function assuming four subdomains. Study Design and Setting: Data from seven samples (N 517,726) using 136 items from nine questionnaires were evaluated. A generalized partial credit model was used to estimate item parameters, which were normed to a mean of 50 (SD 510) in the US population. Item bank properties were evaluated through Computerized Adaptive Test (CAT) simulations. Results: IRT requirements were fulfilled by 70 items covering activities of daily living, lower extremity, and central body functions. The original item context partly affected parameter stability. Items on upper body function, and need for aid or devices did not fit the IRT model. In simulations, a 10-item CAT eliminated floor and decreased ceiling effects, achieving a small standard error (!2.2) across scores from 20 to 50 (reliability O0.95 for a representative US sample). This precision was not achieved over a similar range by any comparable fixed length item sets. Conclusion: The methods of the PROMIS project are likely to substantially improve measures of physical function and to increase the

The objective of the study was to examine the burden of coronary artery disease (CAD) and heart failure (HF) on health-related quality of life (HRQOL) and the HRQOL trajectory among participants in a disease management (DM) program characterized by personalized models of education, counseling, and supportive contact. In all, 2,590 CAD and 3,182 HF patients were assessed at baseline and at 3, 6, 9, and 12 months post-enrollment. HRQOL was measured via a computerized dynamic test, whose core consisted of SF-8 items. HRQOL burden was assessed by comparing physical component summary (PCS) and mental component summary (MCS) scores to demographically adjusted US norms and to historical controls. Disease trajectories were assessed with change score analyses and by a categorization of participants as improving, stable, or deteriorating. Among the results, both groups showed between 1.7 to 2.6 times the likelihood of improving over worsening after a full year of DM participation in all measures. In contrast, historical controls experienced no significant HRQOL improvement or decline after 2 years of standard treatment. After 1 or 2 years they were more likely to decline than to improve in their PCS scores and were about as likely to improve as to worsen in their MCS scores. In conclusion, HF places a substantial burden on HRQOL, and the burden of CAD is also noticeable. While the study design does not allow causal interpretations, HRQOL significantly improved for both CAD and HF patients during DM program participation. This trend is in contrast to historic controls, where no significant HRQOL improvement occurred over time.

To evaluate a patient-reported participation measure constructed within the framework of the International Classification of Functioning, Disability, and Health.The Participation Measure for Post-Acute Care (PM-PAC) contains 51 items that assess participation in nine domains: mobility; role functioning; community, social, and civic life; domestic life/self-care; economic life; interpersonal relationships; communication; work; and education. Self-reported data were collected by interview with 395 noninstitutionalized rehabilitation patients. Psychometric analyses were conducted to test assumptions underlying the scaling and scoring of PM-PAC scales and to evaluate reliability and validity.In general, analyses supported assignment of items to hypothesized scales. However, the community, social, and civic life, interpersonal relationships, and communication domains were highly correlated. Item response theory models indicated that items were directed primarily at people with worse than average limitations in participation than the average patient in this rehabilitation sample. Test and retest scale scores did not differ significantly (intraclass correlation coefficient range, 0.61-0.86). Groups with more severe conditions scored worse on PM-PAC scales, as hypothesized.PM-PAC is a promising new measure of patient-reported participation as defined by the International Classification of Functioning, Disability, and Health. Information about PM-PAC items from this study will be useful in developing a computerized, adaptive measure of participation.

BACKGROUND: Thyroid diseases affect quality of life (QoL). The Thyroid-Related Patient-Reported Outcome (ThyPRO) is an international comprehensive well-validated patient-reported outcome, measuring thyroid-related QoL. The current version is rather long-85 items. The purpose of the present study was to develop an abbreviated version of the ThyPRO, with conserved good measurement properties.METHODS: A cross-sectional (N = 907) and a longitudinal sample (N = 435) of thyroid patients were analyzed. A graded item response theory (IRT) model was fitted to the cross-sectional data. Short-form scales with three items were aimed for, by selecting items with best fit according to the IRT model, avoiding cross-culturally noninvariant items. Seven scales measuring mental and social well-being and function as well as one overall QoL impact item were analyzed in a bifactor model, to develop a supplementary composite score. Short-form scales were linked to original scales with IRT-based summed-score-linking. Agreement between the short and long form was estimated by agreement plots, intraclass correlations, and mean score levels. Responsiveness was compared by relative validity indices, clinical validity by ability to detect clinically relevant differences, and test-retest reliability by intra-class correlation.RESULTS: One four-item scale was not abbreviated and one two-item scale was omitted from the short-form. For the 11 scales undergoing abbreviation, 10 with three and one with four items were developed. A bifactor model with good overall fit was fitted to the composite score, including the single QoL item. Responsiveness and clinical validity of the short-form scales were preserved, as were test-retest reliability (0.75-0.89). Short- versus long-form intraclass correlations were high (0.89-0.98), and the mean scale levels were similar.CONCLUSIONS: A 39-item version of the ThyPRO, with good measurement properties, was developed and is recommended for clinical use.

Purpose The Quality-of-life (QOL) Disease Impact Scale (QDIS) standardizes the content and scoring of QOL impact attributed to different diseases using item response theory (IRT). This study examined the IRT invariance of the QDISstandardized IRT parameters in an independent sample. Method The differential functioning of items and test (DFIT) of a static short-form (QDIS-7) was examined across two independent sources: patients hospitalized for acute coronary syndrome (ACS) in the TRACE-CORE study (N = 1,544) and chronically ill US adults in the QDIS standardization sample. ‘‘ACS-specific’’ IRT item parameters were calibrated and linearly transformed to compare to ‘‘standardized’’ IRT item parameters. Differences in IRT model-expected item, scale and theta scores were examined. The DFIT results were also compared in a standard logistic regression differential item functioning analysis. Results Item parameters estimated in the ACS sample showed lower discrimination parameters than the standardized discrimination parameters, but only small differences were found for thresholds parameters. In DFIT, results on the non-compensatory differential item functioning index (range 0.005–0.074) were all below the threshold of 0.096. Item differences were further canceled out at the scale level. IRT-based theta scores for ACS patients using standardized and ACS-specific item parameters were highly correlated (r = 0.995, root-mean-square difference = 0.09). Using standardized item parameters, ACS patients scored one-half standard deviation higher (indicating greater QOL impact) compared to chronically ill adults in the standardization sample. Conclusion The study showed sufficient IRT invariance to warrant the use of standardized IRT scoring of QDIS-7 for studies comparing the QOL impact attributed to acute coronary disease and other chronic conditions.

Role functioning and its limitations due to one's health is an important aspect of health-related quality of life (HRQoL). The Medical Outcomes Study (MOS) SF-36 includes 2 role functioning scales: role limitations due to physical health problems (RP) or emotional problems (RE). Although they capture important concepts of HRQoL, these 2 scales have some limitations in their measurement properties. Using dichotomized sets of response choices, the scales are limited in their distributional properties (eg, higher standard deviation than other SF-36 scales) and ability to discriminate between clinically relevant groups. In this study, we ascertain the improvements to these 2 scales using 5-point ordinal response choices for each of the scale items. Two thousand one hundred sixty-two patients from the Veterans Health Study (VHS), an observational study of health outcomes in patients receiving ambulatory care, completed a health status questionnaire and a medical history. The health questionnaire included (1) the MOS SF-36, in which the RP and RE items used dichotomized yes/no responses; and (2) a set of modified RP and RE items that used 5-response choices for each of the items, ranging from "no, none of the time" to "yes, all of the time." We compared the original and modified RP and RE scales using internal consistency reliability and factor analysis. We tested item convergent and discriminant validity using multitrait scaling, and scale discriminant validity using ordinary least squares regression. Results indicate that the modifications to the original RP and RE scales accomplish important gains in the distributional properties of the scales. The floor and ceiling effects of the 2 scales have been reduced and the reliability of the RP scale has increased (0.87-0.95). Factor analysis and multitrait scaling tests indicate that the modified items have the same interpretation as the original items. Tests of discriminant validity indicate that the modified RP and RE scales have greater explanatory power for measures of disease burden, depression, and disease severity. The modified SF-36 role scales are clearly superior to the original versions. The modifications have increased the explained variability, suggesting greater explanatory power and more information obtained by the role functioning measures. The modified RP and RE are capturing a wider spectrum of disease severity, in part due to the lowering of the floor and raising of the ceiling of the scales. Additional work needs to test these improvements in other populations and to expand the analysis to track the responsiveness of the modified scales to clinically and socially important changes over time.

Background: Item response theory (IRT) is a powerful framework for analyzing multiitem scales and is central to the implementation of computerized adaptive testing. Objectives: To explain the use of IRT to examine measurement properties and to apply IRT to a questionnaire for measuring migraine impact – the Migraine Specific Questionnaire (MSQ). Methods: Data from three clinical studies that employed the MSQ-version 1 were analyzed by confirmatory factor analysis for categorical data and by IRT modeling. Results: Confirmatory factor analyses showed very high correlations between the factors hypothesized by the original test constructions. Further, high item loadings on one common factor suggest that migraine impact may be adequately assessed by only one score. IRT analyses of the MSQ were feasible and provided several suggestions as to how to improve the items and in particular the response choices. Out of 15 items, 13 showed adequate fit to the IRT model. In general, IRT scores were strongly associated with the scores proposed by the original test developers and with the total item sum score. Analysis of response consistency showed that more than 90% of the patients answered consistently according to a unidimensional IRT model. For the remaining patients, scores on the dimension of emotional function were less strongly related to the overall IRT scores that mainly reflected role limitations. Such response patterns can be detected easily using response consistency indices. Analysis of test precision across score levels revealed that the MSQ was most precise at one standard deviation worse than the mean impact level for migraine patients that are not in treatment. Thus, gains in test precision can be achieved by developing items aimed at less severe levels of migraine impact. Conclusions: IRT proved useful for analyzing the MSQ. The approach warrants further testing in a more comprehensive item pool for headache impact that would enable computerized adaptive testing.

Background: Item response theory (IRT) scoring of health status questionnaires offers many advantages. However, to ensure 'backwards comparability' and to facilitate interpretations of results, we need the ability to express the IRT score in the metrics of the traditional scales. Objectives: To develop procedures to calibrate IRT-based scores on the Headache Impact Test (HIT) into the metrics of the traditional headache scales. To assess the degree to which the calibrated HIT scores agree with the observed traditional scores and lead to the same conclusions in group comparisons. Methods: We used telephone interview data (n = 1016) and Internet data (n = 1103) from general population surveys of recent headache sufferers. Analyses were conducted in four steps: (1) develop IRT models for all items, (2) for each IRT score level, calculate the expected score on each of the traditional scales (calibration), (3) adjust this calibrated score for measurement error in the IRT score, (4) for each of the traditional scales, assess agreement between calibrated HIT scores and observed scores using intraclass correlation (ICC) and evaluate the agreement of mean scores and the relative validity (RV) in discriminating among groups differing in migraine diagnosis, headache severity, and change in impact over time. Results: For the traditional categorical questionnaire items (the Migraine Specific Questionnaire (MSQ) and the Headache Disability Inventory (HDI)) the calibrated HIT agreed with the observed traditional scores: ICC's were between 0.80 and 0.94. In RV analyses the maximum mean difference between the observed and expected scores was 1.7 points on a 0–100 scale for comparisons at one point in time. Analyses of change over time and analyses calibrating scores from the fixed-form HIT-6 to the metric of other questionnaires were also satisfactory although less precise. Analysis of non-standard questionnaire items (e.g. On how many days in the past 3 months did you have a headache, from the HIMQ and the MIDAS) required special IRT models. Agreement was less good: ICC's were between 0.56 and 0.61 and the maximum mean differences were 2.9 (on a 0–270 scale) and 3.8 (on a 0–450 scale) in RV analyses at one point in time. The ability of the calibrated scale scores to discriminate between groups was at least as good as the ability of the observed sum scales and often remarkably better. Conclusion: The theoretical advantage of IRT models in scale calibration is supported by our results. This approach to achieving comparability of new and widely-used scales and accelerating the accumulation of interpretation guidelines based on previous work warrant testing for measures of other generic and disease-specific concepts.

Objective: To evaluate the feasibility of computerized adaptive testing (CAT) and the reliability and validity of CAT-based estimates of headache impact scores in comparison with 'static' surveys. Methods: Responses to the 54-item Headache Impact Test (HIT) were re-analyzed for recent headache sufferers (n = 1016) who completed telephone interviews during the National Survey of Headache Impact (NSHI). Item response theory (IRT) calibrations and the computerized dynamic health assessment (DYNHA®) software were used to simulate CAT assessments by selecting the most informative items for each person and estimating impact scores according to pre-set precision standards (CAT-HIT). Results were compared with IRT estimates based on all items (total-HIT), computerized 6-item dynamic estimates (CAT-HIT-6), and a developmental version of a 'static' 6-item form (HIT-6-D). Analyses focused on: respondent burden (survey length and administration time), score distributions ('ceiling' and 'floor' effects), reliability and standard errors, and clinical validity (diagnosis, level of severity). A random sample (n = 245) was re-assessed to test responsiveness. A second study (n = 1103) compared actual CAT surveys and an improved 'static' HIT-6 among current headache sufferers sampled on the Internet. Respondents completed measures from the first study and the generic SF-8™ Health Survey; some (n = 540) were re-tested on the Internet after 2 weeks. Results: In the first study, simulated CAT-HIT and total-HIT scores were highly correlated (r = 0.92) without 'ceiling' or 'floor' effects and with a substantial reduction (90.8%) in respondent burden. Six of the 54 items accounted for the great majority of item administrations (3603/5028, 77.6%). CAT-HIT reliability estimates were very high (0.975–0.992) in the range where 95% of respondents scored, and relative validity (RV) coefficients were high for diagnosis (RV = 0.87) and severity (RV = 0.89); patient-level classifications were accurate 91.3% for a diagnosis of migraine. For all three criteria of change, CAT-HIT scores were more responsive than all other measures. In the second study, estimates of respondent burden, item usage, reliability and clinical validity were replicated. The test–retest reliability of CAT-HIT was 0.79 and alternate forms coefficients ranged from 0.85 to 0.91. All correlations with the generic SF-8 were negative. Conclusions: CAT-based administrations of headache impact items achieved very large reductions in respondent burden without compromising validity for purposes of patient screening or monitoring changes in headache impact over time. IRT models and CAT-based dynamic health assessments warrant testing among patients with other conditions.

Background: Measurement of headache impact is important in clinical trials, case detection, and the clinical monitoring of patients. Computerized adaptive testing (CAT) of headache impact has potential advantages over traditional fixed-length tests in terms of precision, relevance, real-time quality control and flexibility. Objective: To develop an item pool that can be used for a computerized adaptive test of headache impact. Methods: We analyzed responses to four well-known tests of headache impact from a population-based sample of recent headache sufferers (n = 1016). We used confirmatory factor analysis for categorical data and analyses based on item response theory (IRT). Results: In factor analyses, we found very high correlations between the factors hypothesized by the original test constructers, both within and between the original questionnaires. These results suggest that a single score of headache impact is sufficient. We established a pool of 47 items which fitted the generalized partial credit IRT model. By simulating a computerized adaptive health test we showed that an adaptive test of only five items had a very high concordance with the score based on all items and that different worst-case item selection scenarios did not lead to bias. Conclusion: We have established a headache impact item pool that can be used in CAT of headache impact.

Background: Migraine and other severe headaches can cause suffering and reduce functioning and productivity. Patients are the best source of information about such impact. Objective: To develop a new short form (HIT-6) for assessing the impact of headaches that has broad content coverage but is brief as well as reliable and valid enough to use in screening and monitoring patients in clinical research and practice. Methods: HIT-6 items were selected from an existing item pool of 54 items and from 35 items suggested by clinicians. Items were selected and modified based on content validity, item response theory (IRT) information functions, item internal consistency, distributions of scores, clinical validity, and linguistic analyses. The HIT-6 was evaluated in an Internet-based survey of headache sufferers (n = 1103) who were members of America Online (AOL). After 14 days, 540 participated in a follow-up survey. Results: HIT-6 covers six content categories represented in widely used surveys of headache impact. Internal consistency, alternate forms, and test–retest reliability estimates of HIT-6 were 0.89, 0.90, and 0.80, respectively. Individual patient score confidence intervals (95%) of app. ±5 were observed for 88% of all respondents. In tests of validity in discriminating across diagnostic and headache severity groups, relative validity (RV) coefficients of 0.82 and 1.00 were observed for HIT-6, in comparison with the Total Score. Patient-level classifications based in HIT-6 were accurate 88.7% of the time at the recommended cut-off score for a probability of migraine diagnosis. HIT-6 was responsive to self-reported changes in headache impact. Conclusions: The IRT model estimated for a 'pool' of items from widely used measures of headache impact was useful in constructing an efficient, reliable, and valid 'static' short form (HIT-6) for use in screening and monitoring patient outcomes.

Background: While item response theory (IRT) offers many theoretical advantages over classical test theory in the construction and scoring of patient based measures of health few studies compare scales constructed from both methodologies head to head. Objective: Compare the responsiveness to treatment of migraine specific scales scored using summated rating scale methods vs. IRT methods. Methods: The data came from three clinical studies of migraine treatment that used the Migraine Specific Quality of Life Questionnaire (MSQ). Five methods of quantifying responsiveness were used to evaluate and compare changes from pre- to post-treatment in MSQ scales scored using Likert and IRT scaling methods. Results: Changes in all MSQ scale scores from pre- to post-treatment were highly significant in all three studies. A single index scored from the MSQ using IRT methods was determined to be more responsive than any one of the MSQ subscales across the five methods used to quantify responsiveness. Across 13 of the 15 tests (5 responsiveness methods * 3 studies) conducted, the single index scored from the MSQ using IRT methods was the most responsive measure. Conclusions: IRT methods increased the responsiveness of the MSQ to the treatment of migraine. The results agree with the psychometric evidence that suggest that it is feasible to score a single index from the MSQ using IRT methods. This approach warrants further testing with other measures of migraine impact.

Background: Migraine headaches have been shown to have substantial personal and societal implications. Health-related quality of life (HRQOL) assessments of migraineurs have been used to monitor and evaluate patient- and population-based outcomes, and to evaluate effectiveness and responsiveness to treatment. In this paper, we test a new, even shorter generic health survey, the SF-8™ Health Survey (SF-8™), an alternate form that uses one question to measure each of the eight SF-36® Health Survey (SF-36®) domains, in a sub-sample of migraine sufferers. Methods: Data from 7557 participants surveyed via the Internet and mail were used to document the burden of migraine on HRQOL and to compare the relative burden of migraine with other chronic conditions using the SF-8. Results: Migraineurs' HRQOL is similar to those with congestive heart failure, hypertension and diabetes, and is better than those with depression. Migraine sufferers experience better physical health and worse mental health (MH) than those with osteoarthritis. Results support prior research indicating that the burden of migraine on functional health and well-being is considerable and comparable to other chronic conditions known to have substantial impact on HRQOL. Conclusions: The SF-8 may provide a more practical and efficient method to describe the burden of migraine in population studies.

Analyses of cognitive aspects of survey methodology (CASM) and psychometric analysis are two methods that are able to complement each other. We use concrete examples to illustrate how psychometric analyses can test hypotheses from CASM. The psychometrics framework recognizes that survey responses are affected by other factors than the concept being assessed, for example by cognitive factors and processes. Such factors are subsumed under the concept of measurement error. Possible sources of measurement error can be tested, e.g. by randomized experiments. A standard way to reduce measurement error is to ask several questions about the same concept and combine the answers into a multi-item scale that is more precise than the individual items. Techniques like structural equation models use the item correlations to assess the magnitude of measurement error and to test the assumptions behind the multi-item scale, e.g. the effect of common response choices and item time frames. A central problem in modern psychometrics is how to model the mapping of the continuous latent variable onto the item response choice categories. This is achieved by threshold models (e.g. item response models and structural equation models for categorical data). These models can, for example, analyze the impact of mode of administration, test whether the items function in the same way for all people (measurement invariance/differential item functioning) and examine the consistency of responses from any single person. Such analyses provide new possibilities for combining psychometrics and cognitive methods.

To assess whether cilostazol, a phosphodiesterase III inhibitor, improves treadmill and community-based walking ability and health-related quality of life (HQL) in patients with intermittent claudication resulting from peripheral arterial disease (PAD).Retrospective meta-analysis of data pooled from six Phase 3, multicenter, double-blind, placebo-controlled, parallel-group, randomized studies.Patients were recruited from outpatient ambulatory medical care facilities.Patients' (n = 1,751) mean age +/- standard deviation was 65 +/- 9, and they had a history of PAD for 6 months or longer and an ankle brachial index (ABI) of 0.90 or less.Cilostazol 50 mg bid or 100 mg bid for 12, 16, or 24 weeks.ABI; maximal walking distance (MWD); pain-free walking distance on a graded and constant-load treadmill; and HQL, measured using the Walking Impairment Questionnaire (WIQ) and the Medical Outcomes Study Short Form-36 (SF-36).Maximal treadmill walking distance improved more in both cilostazol groups than in the placebo group (both P.0001). WIQ and SF-36 physical summary scores improved significantly more with cilostazol than with placebo (for instance, WIQ distance score, P.0001 and SF-36 physical summary score, P.0001, comparing persons taking cilostazol with controls). Improved MWD correlated with improvements in WIQ (correlation with distance score, r = 0.34, P.0001) and SF-36 physical summary scores (r = 0.29, P.0001).Treatment with cilostazol was associated with greater improvements in community-based walking ability and HQL in patients with intermittent claudication than treatment with placebo. These improvements correlated with increased MWD. This analysis of effects of cilostazol on improving walking ability in persons with claudication is the first cilostazol study focused on community-based measures of functional status and HQL. Questionnaires assessing walking ability and HQL provide important patient-based information about clinical outcomes of claudication therapy.

Vitality is an important domain reflecting both the physical and emotional components of health-related quality of life. Because of its complexity, it has been defined and measured both broadly and narrowly. We explored the dimensionality of a very comprehensive item bank hypothesized to measure vitality and its related concepts. Secondary analyses were conducted using the responses of 1,343 adults representative of the US general population to Internet-based surveys including 42 items compiled from multiple scales (e.g., SF-36 Vitality, PROMIS-Fatigue), covering a broad range of vitality-related content areas (energy, fatigue, and their interference with physical, mental, social activities, and quality of life). Exploratory and confirmatory factor models were evaluated independently using split-half samples. Bifactor model was used to assess the essential unidimensionality of the items, in comparison with traditional unidimensional, multidimensional, and hierarchical models. Method effects of a common scale or phrase were modeled via correlating errors. The exploratory factor analysis identified one dominant factor. The confirmatory factor analysis identified a best-fitting (CFI = 0.964, RMSEA = 0.084) bifactor model with one general (vitality) and two group (energy and fatigue) factors, explaining 69, 3, and 4 % of total variance. Correlating errors accounting for the method effects were important in identifying the substantive dimensionality of the items. The bifactor model proved to be useful for evaluating the dimensionality of a complex construct. Results supported conceptualizing and measuring vitality as a unidimensional energy-fatigue construct. We encourage future studies comparing practical implications of measures based on the broader and narrower conceptualizations of vitality.

To evaluate the responsiveness of the SF-36 Health Survey in drug trials and to determine how often clinically efficacious treatments produce meaningful functional health changes across medical conditions.We conducted a systematic review of randomized, double-blind, placebo-controlled drug trials published from 1995 to 2011 that documented results for primary clinical endpoints and SF-36 outcomes. PubMed and a database of SF-36 publications were searched. We evaluated responsiveness as concordance (both statistically significant or both nonsignificant) between primary clinical and SF-36 outcomes. To determine how often SF-36 physical and mental component summary (PCS, MCS) score changes were of meaningful magnitude, mean net of placebo changes with treatment were compared against the developer's recommended 3-point threshold for a minimal important difference (MID) across groups of medical conditions.Of 805 screened trials, 185 met eligibility criteria. Primary clinical and SF-36 outcomes were concordant in 151 trials (82%). Among clinically efficacious trials, 58% reported net mean SF-36 improvements ≥MID threshold; however, SF-36 changes were often modest (PCS IQR, 1.6-4.1; MCS IQR, 0.8-3.5). Variations in treatment impact were apparent across conditions. Clinically efficacious therapies for rheumatoid arthritis, psoriatic arthritis, and psoriasis consistently achieved the largest SF-36 improvements, with 87% exceeding MID, whereas no efficacious therapies for peripheral arterial disease or chronic obstructive pulmonary disease achieved MID threshold.The SF-36 responds to treatment impact, distinguishing drug therapies that, on average, produce meaningful functional health benefits. Overall, just over half of clinically efficacious trials report meaningful functional health improvements, and results vary widely by medical condition.