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.

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).

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.

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.

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.

Evaluation of the Patient-Reported Outcomes Information System (PROMIS(®)) Spanish-language physical functioning items.

PURPOSE: To evaluate the equivalence of the PROMIS(®) physical functioning item bank by language of administration (English versus Spanish). METHODS: The PROMIS(®) wave 1 English-language physical functioning bank consists of 124 items, and 114 of these were translated into Spanish. ANALYSIS: Item frequencies, means and standard deviations, item-scale correlations, and internal consistency reliability were calculated. The IRT assumption of unidimensionality was evaluated by fitting a single-factor confirmatory factor analytic model. IRT threshold and discrimination parameters were estimated using Samejima's Graded Response Model. DIF by language of administration was evaluated. RESULTS: Item means ranged from 2.53 (SD = 1.36) to 4.62 (SD = 0.82). Coefficient alpha was 0.99, and item-rest correlations ranged from 0.41 to 0.89. A one-factor model fits the data well (CFI = 0.971, TLI = 0.970, and RMSEA = 0.052). The slope parameters ranged from 0.45 ("Are you able to run 10 miles?") to 4.50 ("Are you able to put on a shirt or blouse?"). The threshold parameters ranged from -1.92 ("How much do physical health problems now limit your usual physical activities (such as walking or climbing stairs)?") to 6.06 ("Are you able to run 10 miles?"). Fifty of the 114 items were flagged for DIF based on an R(2) of 0.02 or above criterion. The expected total score was higher for Spanish- than English-language respondents. CONCLUSIONS: English- and Spanish-speaking subjects with the same level of underlying physical function responded differently to 50 of 114 items. This study has important implications in the study of physical functioning among diverse populations.

Upper-extremity and mobility subdomains from the Patient-Reported Outcomes Measurement Information System (PROMIS) adult physical functioning item bank.

OBJECTIVE: To create upper-extremity and mobility subdomain scores from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning adult item bank. DESIGN: Expert reviews were used to identify upper-extremity and mobility items from the PROMIS item bank. Psychometric analyses were conducted to assess empirical support for scoring upper-extremity and mobility subdomains. SETTING: Data were collected from the U.S. general population and multiple disease groups via self-administered surveys. PARTICIPANTS: The sample (N=21,773) included 21,133 English-speaking adults who participated in the PROMIS wave 1 data collection and 640 Spanish-speaking Latino adults recruited separately. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: We used English- and Spanish-language data and existing PROMIS item parameters for the physical functioning item bank to estimate upper-extremity and mobility scores. In addition, we fit graded response models to calibrate the upper-extremity items and mobility items separately, compare separate to combined calibrations, and produce subdomain scores. RESULTS: After eliminating items because of local dependency, 16 items remained to assess upper extremity and 17 items to assess mobility. The estimated correlation between upper extremity and mobility was .59 using existing PROMIS physical functioning item parameters (r=.60 using parameters calibrated separately for upper-extremity and mobility items). CONCLUSIONS: Upper-extremity and mobility subdomains shared about 35% of the variance in common, and produced comparable scores whether calibrated separately or together. The identification of the subset of items tapping these 2 aspects of physical functioning and scored using the existing PROMIS parameters provides the option of scoring these subdomains in addition to the overall physical functioning score.

Differences in CAHPS reports and ratings of health care provided to adults and children.

BACKGROUND: Consumer assessment of health care is an important metric for evaluating quality of care. These assessments can help purchasers, health plans, and providers deliver care that fits patients' needs. OBJECTIVE: To examine differences in reports and ratings of care delivered to adults and children and whether they vary by site. RESEARCH DESIGN: This observational study compares adult and child experiences with care at a large west coast medical center and affiliated clinics and a large mid-western health plan using Consumer Assessment of Healthcare Providers and Systems Clinician & Group 1.0 Survey data. RESULTS: Office staff helpfulness and courtesy was perceived more positively for adult than pediatric care in the west coast site. In contrast, more positive perceptions of pediatric care were observed in both sites for coordination of care, shared decision making, overall rating of the doctor, and willingness to recommend the doctor to family and friends. In addition, pediatric care was perceived more positively in the mid-west site for access to care, provider communication, and office staff helpfulness and courtesy. The differences between pediatric care and adult care were larger in the mid-western site than the west coast site. CONCLUSIONS: There are significant differences in the perception of care for children and adults with care provided to children tending to be perceived more positively. Further research is needed to identify the reasons for these differences and provide more definitive information at sites throughout the United States.

Development and implementation of a dental office assessment program.

This paper summarizes steps taken by a large U.S. commercial dental plan to meet measurement challenges through development of a program designed to assess and improve the practices of dentists enrolled in a large preferred provider network. Data collected by trained evaluators who assessed 1,428 dental offices using a structured office assessment instrument were subjected to psychometric analysis by UCLA researchers. Results suggested that the optimal structure for an office assessment instrument consisted of 71 items organized into 10 scales (clusters of measures) reflecting key aspects of dental practice.

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.

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.

Effects of mode and order of administration on generic health-related quality of life scores.

OBJECTIVE: We evaluate the effects of mode and order of administration on health-related quality of life (HRQOL) scores. METHOD: We analyzed HRQOL data from the Clinical Outcomes and Measurement of Health Study (COMHS). In COMHS, we enrolled patients with heart failure or cataracts at three sites (University of California, San Diego, University of California, Los Angeles, and University of Wisconsin). Patients completed self-administered HRQOL instruments at baseline and months 1 and 6 post-baseline, including the EuroQol (EQ-5D), Health Utilities Index (HUI), Quality of Well-Being Scale--self-administered (QWB-SA), and the Short Form (SF)-36v2. At the 6 months follow-up, individuals were randomized to mail or telephone administration first, followed by the other mode of administration. We used repeated measures mixed effects models, adjusting for site, patient age, education, gender, and race. RESULTS: Included were 121 individuals entering a heart failure program and 326 individuals scheduled for cataract surgery who completed the survey by mail or phone at the 6-month follow-up. The majority of the sample was female (53%) and white (86%). About a quarter of the sample had high school education or less (26%). The average age was 66 (36-91 range). HRQOL scores were higher (more positive) for phone administration following mail administration. The largest differences in scores between phone and mail responses occurred for comparisons of telephone responses for those who were randomized to a mail survey first compared with mail responses for those randomized to a telephone survey first (i.e., mode effects for responses that were given on the second administration of the HRQOL measures). The QWB-SA was the only measure that did not display the pattern of mode effects. The biggest differences between modes were 4 points on the SF-36v2 physical health and mental health component summary scores, 0.06 on the SF-6D, 0.03 on the QWB-SA, 0.08 on the EQ-5D, 0.04 on the HUI2, and 0.10 on the HUI3. CONCLUSIONS: Telephone administration yields significantly more positive HRQOL scores for all of the generic HRQOL measures except for the QWB-SA. The magnitude of effects was clearly important, with some differences as large as a half-standard deviation. These findings confirm the importance of considering mode of administration when interpreting HRQOL scores.

Psychometric properties of an instrument to assess Medicare beneficiaries' prescription drug plan experiences.

Using data from 335,249 Medicare beneficiaries who responded to the 2007 Medicare Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey, along with data from 22 cognitive interviews, we investigated the reliability and validity of an instrument designed to assess beneficiaries' experiences with their prescription drug plans. Composite measures derived from the instrument had acceptable internal consistency and sufficient plan-level reliability to inform consumer choice, quality improvement, and payor oversight. These measures were positively associated with members' overall rating of the plan and their willingness to recommend the plan. Moreover, each was independently useful in predicting beneficiaries' global ratings of their plan. This instrument can be an important tool for helping beneficiaries to choose a plan that best meets their needs.

Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items.

BACKGROUND: The use of global health items permits an efficient way of gathering general perceptions of health. These items provide useful summary information about health and are predictive of health care utilization and subsequent mortality. METHODS: Analyses of 10 self-reported global health items obtained from an internet survey as part of the Patient-Reported Outcome Measurement Information System (PROMIS) project. We derived summary scores from the global health items. We estimated the associations of the summary scores with the EQ-5D index score and the PROMIS physical function, pain, fatigue, emotional distress, and social health domain scores. RESULTS: Exploratory and confirmatory factor analyses supported a two-factor model. Global physical health (GPH; 4 items on overall physical health, physical function, pain, and fatigue) and global mental health (GMH; 4 items on quality of life, mental health, satisfaction with social activities, and emotional problems) scales were created. The scales had internal consistency reliability coefficients of 0.81 and 0.86, respectively. GPH correlated more strongly with the EQ-5D than did GMH (r = 0.76 vs. 0.59). GPH correlated most strongly with pain impact (r = -0.75) whereas GMH correlated most strongly with depressive symptoms (r = -0.71). CONCLUSIONS: Two dimensions representing physical and mental health underlie the global health items in PROMIS. These global health scales can be used to efficiently summarize physical and mental health in patient-reported outcome studies.