Health-related quality of life outcomes after neoadjuvant chemoradiotherapy for rectal cancer in NRG Oncology/NSABP R-04.

BACKGROUND: There has been limited evaluation of health-related quality of life (HRQOL) in rectal cancer patients receiving neoadjuvant chemoradiotherapy. HRQOL outcomes in the National Surgical Adjuvant Breast and Bowel Project R-04 trial are examined in this article. METHODS: Between 2004 and 2010, R-04 patients were invited to enroll in the HRQOL substudy, with questionnaires administered before randomization, after completion of chemoradiotherapy, and 1-year after surgery. HRQOL measures included: Functional Assessment of Cancer Therapy for colorectal cancer (FACT-C); Short Form-36v.2 Vitality scale; a treatment-specific symptom scale; and the FACT neurotoxicity scale. A 5-year postsurgery assessment was added to the protocol in 2012. Mixed-effects models examined neoadjuvant therapy treatment effects in the 1-year sample and models that explored associations of host factors and treatment impact on 5-year HRQOL. RESULTS: A total of 1373 patients completed baseline HRQOL and at least one additional assessment. The average age was 58 years (range, 23-85 years), male (68%), and 59% Stage II. There were no statistically significant differences in HRQOL outcomes by treatment arm, but HRQOL worsened from baseline to postneoadjuvant chemoradiotherapy, with statistically significant effect sizes changes ranging from 0.6 (Vitality) to 0.9 (FACT-C Trial Outcome Index). Neurotoxicity was greater in the oxaliplatin-treated groups. Obese/overweight patients had statistically significantly worse FACT-C Trial Outcome Index scores than did underweight/normal weight groups. At 5 years, younger patients and those with normal baseline weight had statistically significantly better physical function scores and older patients had better mental health outcomes. CONCLUSIONS: HRQOL did not differ across the four R-04 treatment arms; however, host factors explained significant variation in posttreatment HRQOL. CLINICALTRIALS: gov: NCT00058474 (https://ClinicalTrials.gov/ct2/show/NCT00058474). LAY SUMMARY: This article reports on the health-related quality of life (HRQOL) outcomes of patients treated with four different chemotherapy regimens combined with radiation in rectal cancer patients before definitive surgical treatment. There were no significant differences in HRQOL by treatment regimen, but all patients experienced decreased vitality (energy) and physical functioning. By 1 year after treatment, most patients had returned to pretreatment vitality and physical functioning, with the exception of increased neurotoxicity. In a subsample of patients assessed at 5 years after surgery, physical function was better in those who at pretreatment were younger, normal weight, and had better performance status. Mental function was better in those who at pretreatment were older and had better performance status.

Health-Related Quality of Life Among United States Service Members with Low Back Pain Receiving Usual Care Plus Chiropractic Care vs Usual Care Alone: Secondary Outcomes of a Pragmatic Clinical Trial.

OBJECTIVE: This study examines Patient-Reported Outcome Measurement Information System (PROMIS®)-29 v1.0 outcomes of chiropractic care in a multi-site, pragmatic clinical trial and compares the PROMIS measures to: 1) worst pain intensity from a numerical pain rating 0-10 scale, 2) 24-item Roland-Morris Disability Questionnaire (RMDQ); and 3) global improvement (modified visual analog scale). DESIGN: A pragmatic, prospective, multisite, parallel-group comparative effectiveness clinical trial comparing usual medical care (UMC) with UMC plus chiropractic care (UMC+CC). SETTING: Three military treatment facilities. SUBJECTS: 750 active-duty military personnel with low back pain. METHODS: Linear mixed effects regression models estimated the treatment group differences. Coefficient of repeatability to estimate significant individual change. RESULTS: We found statistically significant mean group differences favoring UMC+CC for all PROMIS®-29 scales and the RMDQ score. Area under the curve estimates for global improvement for the PROMIS®-29 scales and the RMDQ, ranged from 0.79 to 0.83. CONCLUSIONS: Findings from this pre-planned secondary analysis demonstrate that chiropractic care impacts health-related quality of life beyond pain and pain-related disability. Further, comparable findings were found between the 24-item RMDQ and the PROMIS®-29 v1.0 briefer scales.

Using Item Response Theory to Identify Responders to Treatment: Examples with the Patient-Reported Outcomes Measurement Information System (PROMIS®) Physical Function Scale and Emotional Distress Composite.

The reliable change index has been used to evaluate the significance of individual change in health-related quality of life. We estimate reliable change for two measures (physical function and emotional distress) in the Patient-Reported Outcomes Measurement Information System (PROMIS®) 29-item health-related quality of life measure (PROMIS-29 v2.1). Using two waves of data collected 3 months apart in a longitudinal observational study of chronic low back pain and chronic neck pain patients receiving chiropractic care, and simulations, we compare estimates of reliable change from classical test theory fixed standard errors with item response theory standard errors from the graded response model. We find that unless true change in the PROMIS physical function and emotional distress scales is substantial, classical test theory estimates of significant individual change are much more optimistic than estimates of change based on item response theory.

Applying the Toxicity Index to Patient-Reported Symptom Data: An Example Using the European Organization for Research and Treatment of Cancer Colorectal Cancer-Specific Quality of Life Questionnaire.

PURPOSE: The toxicity index (TI) is a summary index that accounts for toxicity grades associated with cancer symptoms that is more sensitive than other toxicity systems to treatment differences. The TI can be used with patient-reported symptoms but requires that scores for different items represent equivalent severity. The purpose of this article is to provide an example of scoring patient-reported symptoms that satisfies the requirement of equivalent symptom severity. METHODS: A sample of 1232 adults with rectal cancer from a Phase III clinical trial self-reported 18 symptoms on the European Organization for Research and Treatment of Cancer colorectal cancer measure using a 4-category response scale (not at all, a little bit, quite a bit, or very much). The participants were 22 to 85 years of age (mean age, 57 years), 30% were female, 85% were non-Hispanic white, 59% had stage II cancer, and 41% had stage III cancer. A recoded TI was created using item response theory category thresholds. FINDINGS: The recoded TI had larger rank-order correlations than the original TI with Karnofsky performance status index, hemoglobin level, symptom bother, and other aspects of health-related quality of life. IMPLICATIONS: Recoding items based on category thresholds yielded a more valid TI score that can be used to summarize adverse events.

Assessing the Significance of Individual Change in 2 Samples of Patients in Treatment for Low Back Pain Using 5 Different Statistical Indicators.

OBJECTIVE: The purpose of this study was to estimate the significance of individual change using 5 statistical indicators in 2 samples of patients treated for low back pain. METHODS: This secondary analysis used observational and clinical trial data from 2 samples of patients with low back pain to compare 5 ways of estimating significant individual change on the Impact Stratification Score (ISS) administered at the following 2 time points: 3 months apart in an observational study of 1680 patients undergoing chiropractic care, and 6 weeks apart in a randomized trial of 750 active-duty military personnel with low back pain. The following 5 methods were compared: (1) standard deviation index; (2) standard error of measurement (SEM); (3) standard error of estimate (SEE); (4) standard error of prediction (SEP); and (5) the reliable change index (RCI). The ISS is the sum of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 physical function, pain interference, and pain intensity scores and is scored to have a possible range of 8 (least impact) to 50 (greatest impact). RESULTS: The amount of change on the ISS needed for significant individual change in both samples was 5 for the SEM and for the SEE and 7 for the SEP and RCI. CONCLUSIONS: The results of the current study provide some preliminary support for use of the SEP or the RCI to identify significant individual change and provide estimated thresholds of individual change that can be used for the ISS. The SEP and RCI estimates of significant change were consistent with retrospective ratings of change of at least moderately better in prior research. These 2 were less likely than other methods to classify people with low back pain as responders who have not actually gotten better (false positive). In contrast, the SEM and SEE were less likely to miss real change (false negative).

Experiences With Chiropractic Care for Patients With Low Back or Neck Pain.

BACKGROUND: Musculoskeletal disorders are the second leading cause of disability worldwide. OBJECTIVE: Examine experiences of chiropractic patients in the United States with chronic low back or neck pain. METHOD: Observational study of 1853 chronic low back pain and neck pain patients (74% female) who completed an online questionnaire at the 3-month follow-up that included Consumer Assessment of Healthcare Providers and Systems (CAHPS) items assessing their experiences with care. RESULTS: We found similar reports of communication for the chiropractic sample and patients in the 2016 CAHPS National Database, but 85% in the database versus 79% in the chiropractic sample gave the most positive response to the time spent with provider item. More patients in the CAHPS database rated their provider at the top of the scale (8 percentage points). More chiropractic patients reported always getting answers to questions the same day (16 percentage points) and always being seen within 15 minutes of their appointment time (29 percentage points). CONCLUSIONS: The positive experiences of patients with chronic back and neck pain are supportive of their use of chiropractic care.

Responsiveness of PROMIS® to change in chronic obstructive pulmonary disease.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a progressive chronic disease characterized by airflow obstruction that leads to shortness of breath and substantial negative impacts on health-related quality of life (HRQL). The course of COPD includes periodic acute exacerbations that require changes in treatment and/or hospitalizations. This study was designed to examine the responsiveness of Patient-Reported Outcomes Measurement Information System® (PROMIS®) measures to changes associated with COPD exacerbation recovery. METHODS: A longitudinal analysis using mixed-effects models was conducted of people who were enrolled while stable (n = 100) and those who experienced an acute exacerbation (n = 85). PROMIS (physical function, pain interference, pain behavior, fatigue, anxiety, depression, anger, social roles, discretionary social activities, Global Health, dyspnea severity and dyspnea functional limitations) and COPD-targeted HRQL measures were completed at baseline and at 12 weeks. RESULTS: We administered PROMIS measures using computer adaptive testing (CAT), followed by administration of any remaining short form (SF) items that had not yet been administered by CAT. Examination of the difference between group differences from baseline to 12 weeks in the stable and exacerbation groups revealed that the exacerbation group changed (improved) significantly more than the stable group in anxiety (p < .001 to p < .01; f2 effect size [ES] = 0.023/0.021), fatigue (p < .0001; ES = 0.036/0.047) and social roles (p < .001 to p < .05; ES = 0.035/0.024). All effect sizes were small in magnitude and smaller than hypothesized. Depression was also statistically significant (p < .05, SF only) but the ES was trivial. For all other PROMIS domains, the differences were not significant and ES were trivial. CONCLUSIONS: This longitudinal study provides some support for the validity of the PROMIS fatigue, anxiety, and social roles domains in COPD, but further evaluation of responsiveness is warranted.

Group and Individual-level Change on Health-related Quality of Life in Chiropractic Patients With Chronic Low Back or Neck Pain.

STUDY DESIGN: A prospective observational study. OBJECTIVE: The aim of this study was to evaluate group-level and individual-level change in health-related quality of life among persons with chronic low back pain or neck pain receiving chiropractic care in the United States. SUMMARY OF BACKGROUND DATA: Chiropractors treat chronic low back and neck pain, but there is limited evidence of the effectiveness of their treatment METHODS.: A 3-month longitudinal study of 2024 patients with chronic low back pain or neck pain receiving care from 125 chiropractic clinics at six locations throughout the United States was conducted. Ninety-one percent of the sample completed the baseline and 3-month follow-up survey (n = 1835). Average age was 49, 74% females, and most of the sample had a college degree, were non-Hispanic White, worked full-time, and had an annual income of $60,000 or more. Group-level (within-group t tests) and individual-level (coefficient of repeatability) changes on the Patient-Reported Outcomes Measurement Information System (PROMIS-29) v2.0 profile measure was evaluated: six multi-item scales (physical functioning, pain, fatigue, sleep disturbance, social health, emotional distress) and physical and mental health summary scores. RESULTS: Within-group t tests indicated significant group-level change (P < 0.05) for all scores except for emotional distress, and these changes represented small improvements in health (absolute value of effect sizes ranged from 0.08 for physical functioning to 0.20 for pain). From 13% (physical functioning) to 30% (PROMIS-29 v2.0 Mental Health Summary Score) got better from baseline to 3 months later according to the coefficient of repeatability. CONCLUSION: Chiropractic care was associated with significant group-level improvement in health-related quality of life over time, especially in pain. But only a minority of the individuals in the sample got significantly better ("responders"). This study suggests some benefits of chiropractic on functioning and well-being of patients with low back pain or neck pain. LEVEL OF EVIDENCE: 3.

PROMIS®-29 v2.0 profile physical and mental health summary scores.

PURPOSE: The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. This paper describes the development of physical and mental health summary scores for the PROMIS-29 v2.0. METHOD: We conducted factor analyses of PROMIS-29 scales on data collected from two internet panels (n = 3000 and 2000). RESULTS: Confirmatory factor analyses provided support for a physical health factor defined by physical function, pain (interference and intensity), and ability to participate in social roles and activities, and a mental health factor defined primarily by emotional distress (anxiety and depressive symptoms). Reliabilities for these two summary scores were 0.98 (physical health) and 0.97 (mental health). Correlations of the PROMIS-29 v2.0 physical and mental health summary scores with chronic conditions and other health-related quality of life measures were consistent with a priori hypotheses. CONCLUSIONS: This study develops and provides preliminary evidence supporting the reliability and validity of PROMIS-29 v2.0 physical and mental health summary scores that can be used in future studies to assess impacts of health care interventions and track changes in health over time. Further evaluation of these and alternative summary measures is recommended.

Differential item functioning by language on the PROMIS® physical functioning items for children and adolescents.

PURPOSE: To assess the equivalence of self-reports of physical functioning between pediatric respondents to the English- and Spanish-language patient-reported outcomes measurement information system (PROMIS®) physical functioning item banks. METHODS: The PROMIS pediatric physical functioning item banks include 29 upper extremity items and 23 mobility items. A sample of 5091 children and adolescents (mean age = 12 years, range 8-17; 49% male) completed the English-language version of the items. A sample of 605 children and adolescents (mean age = 12 years, range 8-17; 55% male; 96% Hispanic) completed the Spanish-language version of the items. RESULTS: We found language (English versus Spanish) differential item functioning (DIF) for 4 upper extremity items and 7 mobility items. Product-moment correlations between estimated upper extremity and mobility scores using the English versus the equated Spanish item parameters for Spanish-language respondents were 0.98 and 0.99, respectively. After excluding cases with significant person misfit, we found DIF for the same 4 upper extremity items that had DIF in the full sample and for 12 mobility items (including the same 7 mobility items that had DIF in the full sample). The identification of DIF items between English- and Spanish-language respondents was affected slightly by excluding respondents displaying person misfit. CONCLUSIONS: The results of this study provide support for measurement equivalence of self-reports of physical functioning by children and adolescents who completed the English- and Spanish-language surveys. Future analyses are needed to replicate the results of this study in other samples.

Alternative Approaches to Addressing Non-Normal Distributions in the Application of IRT Models to Personality Measures.

It is generally assumed that the latent trait is normally distributed in the population when estimating logistic item response theory (IRT) model parameters. This assumption requires that the latent trait be fully continuous and the population homogenous (i.e., not a mixture). When this normality assumption is violated, models are misspecified, and item and person parameter estimates are inaccurate. When normality cannot be assumed, it might be appropriate to consider alternative modeling approaches: (a) a zero-inflated mixture, (b) a log-logistic, (c) a Ramsay curve, or (d) a heteroskedastic-skew model. The first 2 models were developed to address modeling problems associated with so-called quasi-continuous or unipolar constructs, which apply only to a subset of the population, or are meaningful at one end of the continuum only. The second 2 models were developed to address non-normal latent trait distributions and violations of homogeneity of error variance, respectively. To introduce these alternative IRT models and illustrate their strengths and weaknesses, we performed real data application comparing results to those from a graded response model. We review both statistical and theoretical challenges in applying these models and choosing among them. Future applications of these and other alternative models (e.g., unfolding, diffusion) are needed to advance understanding about model choice in particular situations.

Differential item functioning of the patient-reported outcomes information system (PROMIS®) pain interference item bank by language (Spanish versus English).

BACKGROUND: About 70% of Latinos, 5 years old or older, in the United States speak Spanish at home. Measurement equivalence of the PROMIS® pain interference (PI) item bank by language of administration (English versus Spanish) has not been evaluated. METHODS: A sample of 527 adult Spanish-speaking Latinos completed the Spanish version of the 41-item PROMIS® pain interference item bank. We evaluate dimensionality, monotonicity and local independence of the Spanish-language items. Then we evaluate differential item functioning (DIF) using ordinal logistic regression with item response theory scores estimated from DIF-free "anchor" items. RESULTS: One of the 41 items in the Spanish version of the PROMIS® PI item bank was identified as having significant uniform DIF. CONCLUSIONS: English- and Spanish-speaking subjects with the same level of pain interference responded differently to 1 of the 41 items in the PROMIS® PI item bank. This item was not retained due to proprietary issues. The original English language item parameters can be used when estimating PROMIS® PI scores.

Two-item PROMIS® global physical and mental health scales.

BACKGROUND: Self-reports of health provide useful information about function and well-being that can improve communication between patients and clinicians. Global health items provide summary information that are predictive of health care utilization and mortality. There is a need for parsimonious global health scales for use in large sample surveys. This study evaluates the reliability and validity of brief measures of global physical health and mental health in the Patient Reported Outcomes Measurement and Information System (PROMIS®) project. METHODS: A total of 21,133 persons included in the PROMIS development sample: 52% female; 82% White, 9% Black, 9% Hispanic; median age of 50 years. We identified two global physical health items (GPH-2) and two global mental health items (GMH-2) with highest discrimination parameters and compared their reliabilities and construct validity to that of the original 4-item scales (GPH-4 and GMH-4) and a single global health item (Global01). RESULTS: Internal consistency reliability was 0.73 for the GPH-2 (versus 0.81 for the GPH-4) and 0.81 for the GMH-2 (versus 0.86 for the GMH-4). Marginal reliabilities were 0.55 for Global01, 0.70 for GPH-2, 0.79 for GPH-4, 0.80 for GMH-2, and 0.86 for GMH-4. The product-moment correlation between the GPH-2 and GPH-4 was 0.94 and between GMH-2 and GMH-4 was 0.97. The 2-item and 4-item versions of the scales had similar correlations with PROMIS domain scores, the EQ-5D-3L and comorbidities, but the 4-item scales were more strongly correlated with these measures. CONCLUSIONS: Adding a single item to a large cross-sectional population survey can cost as much as $100,000. The 2-item variants of the PROMIS global health scales reduce the cost of use on national surveys by 50%, a substantial cost savings. These briefer scales are also more practical for use in clinical practice. The 2-item versions of the PROMIS global health scales display adequate reliability for group comparisons and their associations with other indicators of health are similar to that of the original 4-item scales. The briefer scales are psychometrically sound and reduce burden of survey administration.

Assessment of the Psychometric Properties of a Questionnaire Assessing Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL).

IMPORTANCE: Patient-reported outcome (PRO) measures for laser in situ keratomileusis (LASIK) are needed. OBJECTIVE: To develop PRO measures to assess satisfaction, eye-related symptoms, and their effect on functioning and well-being following LASIK based on patient and expert input. DESIGN, SETTING, AND PARTICIPANTS: The Patient-Reported Outcomes With LASIK (PROWL) studies were prospective observational studies of patients undergoing LASIK surgery for myopia, hyperopia, or astigmatism. PROWL-1 was a single-center study of active-duty US Navy personnel and PROWL-2 was a 5-center study of civilians. PROWL-1 enrolled 262 active-duty service personnel and PROWL-2 enrolled 312 civilians 21 years or older who spoke English; 241 individuals in PROWL-1 and 280 in PROWL-2 completed a baseline questionnaire before surgery. The analytic sample included those also completing 1 or more follow-up questionnaires: 240 (99.6%) of those in PROWL-1 and 271 (94.4%) of those in PROWL-2. Questionnaires were self-administered through the internet preoperatively and at 1 and 3 months postoperatively in both studies and at 6 months postoperatively in PROWL-1. PROWL-1 began in August 2011 and was completed May 30, 2014; PROWL-2 began in July 2012 and was completed June 27, 2014. Data were analyzed from June 28, 2014, to October 24, 2016. MAIN OUTCOMES AND MEASURES: Scales assessing visual symptoms (double images, glare, halos, and starbursts), dry eye symptoms, satisfaction with vision, and satisfaction with LASIK surgery. Items from the National Eye Institute (NEI) Refractive Error Quality of Life Instrument (NEI-RQL-42), NEI Visual Function Questionnaire (NEI-VFQ), and the Ocular Surface Disease Index (OSDI) were included. All scales are scored on a 0 to 100 possible range. Construct validity and responsiveness to change were evaluated (comparing scores before and after surgery). RESULTS: The median age of the 240-person PROWL-1 analytic sample was 27 years (range, 21-52 years); 49 were women (20.4%). The median age of the 271-person PROWL-2 analytic sample was 30 years (range, 21-57 years); 147 were women (54.2%). Internal consistency reliabilities for the 4 visual symptom scales ranged from 0.96 to 0.98 in PROWL-1 and from 0.95 to 0.97 in PROWL-2. The median (interquartile range) test-retest intraclass correlation was 0.69 (0.57-0.79) and 0.76 (0.68-0.84) in PROWL-1 and PROWL-2, respectively. Product-moment correlations of satisfaction with surgery with visual symptom scales at follow-up evaluations ranged from r = 0.24 to r = 0.49. Measures improved from baseline to follow-up, with effect sizes of 0.14 to 1.98, but scores on the NEI-RQL-42 glare scale worsened at the 1-month follow-up. Hours of work did not change significantly from baseline to 1-month follow-up, with the mean number (mean [SD] difference) in PROWL-1 of 41.7 vs 40.9 hours (-0.8 [18.7]) and in PROWL-2 of 38.8 vs 38.2 hours (-0.6 [17.1]). CONCLUSIONS AND RELEVANCE: The results of these studies support the reliability and validity of visual symptom scales to evaluate the effects of LASIK surgery in future studies.

Change in Health-Related Quality-of-Life at Group and Individual Levels Over Time in Patients Treated for Chronic Myofascial Neck Pain.

BACKGROUND: This study evaluated change in health-related quality of life at the group and individual levels in a consecutive series of patients with chronic myofascial neck pain. METHODS: Fifty patients with chronic neck pain self-administered the Short Form-36 Version 2 (SF-36 v2) before treatment and 6 weeks later. Internal consistency reliability was estimated for the 8 scale scores and Mosier's formula was used to estimate reliability of the physical and mental health composite scores. Significance of group-level change was estimated using within-group t statistics. Significance of individual change was evaluated by reliable change index. RESULTS: Statistically significant ( P < .05) group mean improvement over time was found for all SF-36 scores. At the individual level, 20% of the possible changes were statistically significant (17% improvement, 3% decline). CONCLUSIONS: Estimating the significance of individual change in health-related quality of life adds important information in comparing different treatment modalities for chronic myofascial neck pain.

Using Linear Equating to Map PROMIS(®) Global Health Items and the PROMIS-29 V2.0 Profile Measure to the Health Utilities Index Mark 3.

BACKGROUND: Preference-based health-related quality of life (HR-QOL) scores are useful as outcome measures in clinical studies, for monitoring the health of populations, and for estimating quality-adjusted life-years. METHODS: This was a secondary analysis of data collected in an internet survey as part of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) project. To estimate Health Utilities Index Mark 3 (HUI-3) preference scores, we used the ten PROMIS(®) global health items, the PROMIS-29 V2.0 single pain intensity item and seven multi-item scales (physical functioning, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, sleep disturbance), and the PROMIS-29 V2.0 items. Linear regression analyses were used to identify significant predictors, followed by simple linear equating to avoid regression to the mean. RESULTS: The regression models explained 48 % (global health items), 61 % (PROMIS-29 V2.0 scales), and 64 % (PROMIS-29 V2.0 items) of the variance in the HUI-3 preference score. Linear equated scores were similar to observed scores, although differences tended to be larger for older study participants. CONCLUSIONS: HUI-3 preference scores can be estimated from the PROMIS(®) global health items or PROMIS-29 V2.0. The estimated HUI-3 scores from the PROMIS(®) health measures can be used for economic applications and as a measure of overall HR-QOL in research.

U.S. General Population Estimate for "Excellent" to "Poor" Self-Rated Health Item.

BACKGROUND: The most commonly used self-reported health question asks people to rate their general health from excellent to poor. This is one of the Patient-Reported Outcomes Measurement Information System (PROMIS) global health items. Four other items are used for scoring on the PROMIS global physical health scale. Because the single item is used on the majority of large national health surveys in the U.S., it is useful to construct scores that can be compared to U.S. general population norms. OBJECTIVE: To estimate the PROMIS global physical health scale score from the responses to the single excellent to poor self-rated health question for use in public health surveillance, research, and clinical assessment. DESIGN: A cross-sectional survey of 21,133 individuals, weighted to be representative of the U.S. general population. PARTICIPANTS: The PROMIS items were administered via a Web-based survey to 19,601 persons in a national panel and 1,532 subjects from PROMIS research sites. The average age of individuals in the sample was 53 years, 52 % were female, 80 % were non-Hispanic white, and 19 % had a high school degree or lower level of education. MAIN OUTCOME MEASURES: PROMIS global physical health scale. KEY RESULTS: The product-moment correlation of the single item with the PROMIS global physical health scale score was 0.81. The estimated scale score based on responses to the single item ranged from 29 (poor self-rated health, 2.1 SDs worse than the general population mean) to 62 (excellent self-rated health, 1.2 SDs better than the general population mean) on a T-score metric (mean of 50). CONCLUSIONS: This item can be used to estimate scores for the PROMIS global physical health scale for use in monitoring population health and achieving public health objectives. The item may also be used for individual assessment, but its reliability (0.52) is lower than that of the PROMIS global health scale (0.81).

Correlation of PROMIS scales and clinical measures among chronic obstructive pulmonary disease patients with and without exacerbations.

PURPOSE: The Patient-Reported Outcomes Measurement Information System (PROMIS(®)) initiative was developed to advance the methodology of PROs applicable to chronic diseases. Chronic obstructive pulmonary disease (COPD) is a progressive chronic disease associated with poor health. This study was designed to examine the correlation of PROMIS health-related quality of life (HRQOL) scales and clinical measures among COPD patients. METHODS: A cross-sectional analysis was conducted comparing patients who were stable (n = 100) with those currently experiencing a COPD exacerbation (n = 85). All PROMIS measures for adults available at the time of the study (2008), disease-targeted and other HRQOL instruments, health literacy, percent predicted FEV1, and a 6-min walk distance were assessed when patients were considered clinically stable. RESULTS: Stable COPD patients reported significantly (p ≤ 0.05) better health-related quality of life on PROMIS domains than patients experiencing an exacerbation. PROMIS domain scores were significantly (p ≤ 0.01) correlated with each of legacy measures. Six-min walk scores were most highly correlated with the PROMIS physical function domain scores (r = 0.53) followed by the fatigue (r = -0.26), social (r = 0.24) and to a lesser extent depression (r = -0.23), and anxiety (r = -0.22) domain scores. Percent predicted FEV1 score was significantly associated with PROMIS physical function scores (r = 0.27). CONCLUSION: This study provides support for the validity of the PROMIS measures in COPD patients.

Responsiveness and minimally important difference for the patient-reported outcomes measurement information system (PROMIS) 20-item physical functioning short form in a prospective observational study of rheumatoid arthritis.

OBJECTIVE: To estimate responsiveness (sensitivity to change) and minimally important difference (MID) for the Patient-Reported Outcomes Measurement Information System (PROMIS) 20-item physical functioning scale (PROMIS PF-20). METHODS: The PROMIS PF-20, short form 36 (SF-36) physical functioning scale, and Health Assessment Questionnaire (HAQ) were administered at baseline, and 6 and 12 months later to a sample of 451 persons with rheumatoid arthritis. A retrospective change (anchor) item was administered at the 12-month follow-up. We estimated responsiveness between 12 months and baseline, and between 12 months and 6 months using one-way analysis of variance F-statistics. We estimated the MID for the PROMIS PF-20 using prospective change for people reporting getting 'a little better' or 'a little worse' on the anchor item. RESULTS: F-statistics for prospective change on the PROMIS PF-20, SF-36 and HAQ by the anchor item over 12 and 6 months (in parentheses) were 16.64 (14.98), 12.20 (7.92) and 10.36 (12.90), respectively. The MID for the PROMIS PF-20 was 2 points (about 0.20 of an SD). CONCLUSIONS: The PROMIS PF-20 is more responsive than two widely used ('legacy') measures. The MID is a small effect size. The measure can be useful for assessing physical functioning in clinical trials and observational studies.

Age-related Differential Item Functioning for the Patient-Reported Outcomes Information System (PROMIS®) Physical Functioning Items.

PURPOSE: To evaluate the equivalence of the PROMIS® wave 1 physical functioning item bank, by age (50 years or older versus 18-49). MATERIALS AND METHODS: A total of 114 physical functioning items with 5 response choices were administered to English- (n=1504) and Spanish-language (n=640) adults. Item frequencies, means and standard deviations, item-scale correlations, and internal consistency reliability were estimated. Differential Item Functioning (DIF) by age was evaluated. RESULTS: Thirty of the 114 items were fagged for DIF based on an R-squared of 0.02 or above criterion. The expected total score was higher for those respondents who were 18-49 than those who were 50 or older. CONCLUSIONS: Those who were 50 years or older versus 18-49 years old with the same level of physical functioning responded differently to 30 of the 114 items in the PROMIS® physical functioning item bank. This study yields essential information about the equivalence of the physical functioning items in older versus younger individuals.