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Purpose Confirmatory factor analysis fit criteria typically are used to evaluate the unidimensionality of item banks. This study explored the degree to which the values of these statistics are affected by two characteristics of item banks developed to measure health outcomes: large numbers of items and nonnormal data. Methods Analyses were conducted on simulated and observed data. Observed data were responses to the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Impact Item Bank. Simulated data fit the graded response model and conformed to a normal distribution or mirrored the distribution of the observed data. Confirmatory factor analyses (CFA), parallel analysis, and bifactor analysis were conducted. Results CFA fit values were found to be sensitive to data distribution and number of items. In some instances impact of distribution and item number was quite large. Conclusions We concluded that using traditional cutoffs and standards for CFA fit statistics is not recommended for establishing unidimensionality of item banks. An investigative approach is favored over reliance on published criteria. We found bifactor analysis to be appealing in this regard because it allows evaluation of the relative impact of secondary dimensions. In addition to these methodological conclusions, we judged the items of the PROMIS Pain Impact bank to be sufficiently unidimensional for item response theory (IRT) modeling.

•This profile leverages existing PROMIS items with enhanced content relevant for OAK.•Brief, targeted assessment options exist based on research and clinical preferences.•PROMIS metric facilitates comparisons to other conditions and general population.•The profile promotes disease-specific attention and system-wide PRO implementation. The Patient-Reported Outcomes Measurement Information System (PROMIS)-Plus-Osteoarthritis of the Knee (OAK) profile integrates universal PROMIS items with knee-specific items across 13 domains. We evaluated the psychometric properties of a subset of six domains associated with quality of life in people with OAK. In a cross-sectional study of OAK patients (n=600), we estimated reliability using Pearson and Spearman correlations with Knee Injury and Osteoarthritis Outcome Score (KOOS) subscores and known-groups validity with PROMIS Global Health. Measure responsiveness was tested via paired t-tests in a longitudinal study (n=238), pre/post total knee replacement. Across the six domains, internal consistency reliability (Cronbach's alpha) was 0.77−0.95 and test-retest reliability (intraclass correlation coefficients) was ≥0.90. Correlations with Knee Injury and Osteoarthritis Outcome Score (KOOS) subscores and PROMIS Global supported convergent and divergent validity. Known-groups validity testing revealed better scores in all domains for high vs. low global status groups, and knee-specific items added value in physical function and pain. All domains reflected (p<0.001) better health status scores at follow up. The six PROMIS-Plus-OAK profile domains demonstrated good psychometric characteristics. The measure integrates universal and knee-specific content to provide enhanced relevance, measurement precision and efficient administration for patient care and clinical research.

Few interventions have been shown to improve retention in HIV care. We recently completed a randomized, controlled trial of a peer mentoring intervention, which failed to increase retention in care or HIV suppression. We sought to gain insight into this negative result and elicit suggestions for future interventions. We conducted semi-structured one-on-one interviews with a sub-sample of participants and all available interventionists after completion of the primary study. Interviews were coded by two researchers and thematically analyzed. Participants in the intervention arm (N = 16) reported good rapport with and benefit from peer mentoring and found the mentors helpful in facilitating the transition from hospital to out-patient clinic. Control arm participants (N = 9) reported similar emotional and social support benefits from the health educators. In both arms, ongoing challenges including completing paperwork, securing transportation, and rescheduling missed appointments were cited, along with internalized stigma and lack of will to seek care, despite the mentors' best efforts. Suggested improvements to the intervention included: more frequent contact with interventionists; additional support for mental health problems; and targeting overall health rather than a more selective focus on HIV. Mentors and health educators agreed with the participant-reported barriers and added that some participants were too sick to meaningfully participate in the intervention, while others appeared unwilling to engage with the interventionists in a meaningful way. Mentoring was highly acceptable and felt to be impactful, however it was not sufficient to overcome structural barriers or stigma and low motivation in some participants. The attention control intervention may have had an unintended positive impact. Future interventions should focus on broad aspects of health and well-being.

Patient-reported outcome measures are crucial for informed medical decisions and evaluating treatments. However, they can be burdensome for patients and sometimes lack the reliability clinicians need for clear clinical interpretations. We aimed to assess the extent to which applying alternative stopping rules can increase reliability for clinical use while minimizing the burden of computerized adaptive tests (CATs). CAT simulations were conducted on 3 adult item banks in the NIH Toolbox for Assessment of Neurological and Behavioral Function Emotion Battery; the item banks were in the Negative Affect subdomain (ie, Anger Affect, Fear Affect, and Sadness) and contained at least 8 items. In the originally applied NIH Toolbox CAT stopping rules, the CAT was stopped if the score SE reached <0.3 before 12 items were administered. We first contrasted this with a SE-change rule in a planned simulation analysis. We then contrasted the original rules with fixed-length CATs (4-12 items), a reduction of the maximum number of items to 8, and other modifications in post hoc analyses. Burden was measured by the number of items administered per simulation, precision by the percentage of assessments yielding reliability cutoffs (0.85, 0.90, and 0.95), and accurate score recovery by the root mean squared error between the generating θ and the CAT-estimated \"expected a posteriori\"-based θ. In general, relative to the original rules, the alternative stopping rules slightly decreased burden while also increasing the proportion of assessments achieving high reliability for the adult banks; however, the SE-change rule and fixed-length CATs with 8 or fewer items also notably increased assessments yielding reliability <0.85. Among the alternative rules explored, the reduced maximum stopping rule best balanced precision and parsimony, presenting another option beyond the original rules. Our findings demonstrate the challenges in attempting to reduce test burden while also achieving score precision for clinical use. Stopping rules should be modified in accordance with the context of the study population and the purpose of the study.

The management of type 2 diabetes mellitus (T2DM) includes mastery of complex care activities, self-management skills, and routine health care encounters to optimize glucose control and achieve good health. Given the lifelong course of T2DM, patients are faced with navigating complex medical and disease-specific information. This health-seeking behavior is a driver of health disparities and is associated with hospitalization and readmission. Given that health-seeking behavior is a potentially intervenable social determinant of health, a better understanding of how people navigate these complex systems is warranted. To address this need, we aimed to develop new patient-reported outcome (PRO) measures that evaluate health-seeking behavior in persons with T2DM. These new PROs were designed to be included in the Re-Engineered Discharge for Diabetes-Computer Adaptive Test (REDD-CAT) measurement system, which includes several other PROs that capture the importance of social determinants of health. Overall, 225 participants with T2DM completed 56 self-report items that examined health-seeking behaviors. Classical Test Theory and Item Response Theory were used for measurement development. Exploratory factor analysis (EFA; criterion ratio of eigenvalue 1 to eigenvalue 2 being >4; variance for eigenvalue 1 ≥40%) and confirmatory factor analysis (CFA; criterion 1-factor CFA loading <.50; 1-factor CFA residual correlation >.20; comparative fit index ≥0.90; Tucker-Lewis index ≥0.90; root mean square error of approximation <0.15) were used to determine unidimensional sets of items. Items with sparse responses, low-adjusted total score correlations, nonmonotonicity, low factor loading, and high residual correlations of high error modification indices were candidates for exclusion. A constrained graded response model was used to examine item misfit, and differential item functioning was examined to identify item bias. Cronbach α was used to examine internal consistency reliability for the new PROs (criterion ≥0.70), and floor and ceiling effects were examined (criterion ≤20%). Four unidimensional sets of items were supported by EFA (all EFA eigenvalue ratios >4; variance for eigenvalue 1=41.4%-67.3%) and CFA (fit statistics all exceeded criterion values). This included (1) \"Health-Seeking Behavior: PCP-Specific\" (6 items); (2) \"Health-Seeking Behavior: General Beliefs\" (13 items); (3) \"Health-Seeking Behavior: Family or Friends-Specific\" (5 items); and (4) \"Health-Seeking Behavior: Internet-Specific\" (4 items). All items were devoid of differential item functioning for age, sex, education, or socioeconomic status factors. \"Health-Seeking Behavior: General Beliefs\" was developed to include both a computer adaptive test and a 6-item short form version; all other PROs were developed as static short forms. The psychometric reliability of these new PROs was supported; internal consistency ranged from acceptable to excellent (Cronbach α=.78-.91), and measures were free of significant floor or ceiling effects (floor effects range: 0%-8.9%; ceiling effects range: 0%-8.4%). The new REDD-CAT Health-Seeking Behavior PROs provide reliable assessments of health-seeking behaviors among those with T2DM.

Aims Heart failure (HF) is a common and morbid condition impacting multiple health domains. We previously reported the development of the PROMIS®‐Plus‐HF (PROMIS+HF) profile measure, including universal and HF‐specific items. To facilitate use, we developed shorter, PROMIS+HF profiles intended for research and clinical use. Methods and results Candidate items were selected based on psychometric properties and symptom range coverage. HF clinicians (n = 43) rated item importance and clinical actionability. Based on these results, we developed the PROMIS+HF‐27 and PROMIS+HF‐10 profiles with summary scores (0–100) for overall, physical, mental, and social health. In a cross‐sectional sample (n = 600), we measured internal consistency reliability (Cronbach's alpha and Spearman–Brown), test–retest reliability (intraclass coefficient; n = 100), known‐groups validity via New York Heart Association (NYHA) class, and convergent validity with Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. In a longitudinal sample (n = 75), we evaluated responsiveness of baseline/follow‐up scores by calculating mean differences and Cohen's d and comparing with paired t‐tests. Internal consistency was good to excellent (α 0.82–0.94) for all PROMIS+HF‐27 scores and acceptable to good (α/Spearman–Brown 0.60–0.85) for PROMIS+HF‐10 scores. Test–retest intraclass coefficients were acceptable to excellent (0.75–0.97). Both profiles demonstrated known‐groups validity for the overall and physical health summary scores based on NYHA class, and convergent validity for nearly all scores compared with KCCQ scores. In the longitudinal sample, we demonstrated responsiveness for PROMIS+HF‐27 and PROMIS+HF‐10 overall and physical summary scores. For the PROMIS+HF overall summary scores, a group‐based increase of 7.6–8.3 points represented a small to medium change (Cohen's d = 0.40–0.42). For the PROMIS+HF physical summary scores, a group‐based increase of 5.0–5.9 points represented a small to medium change (Cohen's d = 0.29–0.35). Conclusions The PROMIS+HF‐27 and PROMIS+HF‐10 profiles demonstrated good psychometric characteristics with evidence of responsiveness for overall and physical health. These new measures can facilitate patient‐centred research and clinical care, such as improving care quality through symptom monitoring, facilitating shared decision‐making, evaluating quality of care, assessing new interventions, and monitoring during the initiation and titration of guideline‐directed medical therapy.

Background The measurement of healthcare provider performance is becoming more widespread. Physicians have been guarded about performance measurement, in part because the methodology for comparative measurement of care quality is underdeveloped. Comprehensive quality improvement will require comprehensive measurement, implying the aggregation of multiple quality metrics into composite indicators. Objective To present a conceptual framework to develop comprehensive, robust, and transparent composite indicators of pediatric care quality, and to highlight aspects specific to quality measurement in children. Methods We reviewed the scientific literature on composite indicator development, health systems, and quality measurement in the pediatric healthcare setting. Frameworks were selected for explicitness and applicability to a hospital-based measurement system. Results We synthesized various frameworks into a comprehensive model for the development of composite indicators of quality of care. Among its key premises, the model proposes identifying structural, process, and outcome metrics for each of the Institute of Medicine's six domains of quality (safety, effectiveness, efficiency, patient-centeredness, timeliness, and equity) and presents a step-by-step framework for embedding the quality of care measurement model into composite indicator development. Conclusions The framework presented offers researchers an explicit path to composite indicator development. Without a scientifically robust and comprehensive approach to measurement of the quality of healthcare, performance measurement will ultimately fail to achieve its quality improvement goals.

Purpose The study purposes were to mathematically link scores of the Brief Pain Inventory Pain Interference Subscale and the Short Form-36 Bodily Pain Subscale (legacy pain interference measures) to the NIH Patient-Reported Outcome Measurement Information System (PROMIS®) Pain Interference (PROMIS-PI) metric and evaluate results. Methods Linking was accomplished using both equipercentile and item response theory (IRT) methods. Item parameters for legacy items were estimated on the PROMIS-PI metric to allow for pattern scoring. Crosswalk tables also were developed that associated raw scores (summed or average) on legacy measures to PROMIS-PI scores. For each linking strategy, participants' actual PROMIS-PI scores were compared to those predicted based on their legacy scores. To assess the impact of different sample sizes, we conducted random resampling with replacement across 10,000 replications with sample sizes of n = 25, 50, and 75. Results Analyses supported the assumption that all three scales were measuring similar constructs. IRT methods produced marginally better results than equipercentile linking. Accuracy of the links was substantially affected by sample size. Conclusions The linking tools (crosswalks and item parameter estimates) developed in this study are robust methods for estimating the PROMIS-PI scores of samples based on legacy measures. We recommend using pattern scoring for users who have the necessary software and score crosswalks for those who do not.

Purpose To describe the psychometric properties (e.g., data distribution characteristics, convergent/discriminant validity, internal consistency reliability, and test administration characteristics) of the spinal cord injury quality of life measurement system (SCI-QOL) Resilience item bank delivered as a computer adaptive test (CAT) in a sample of individuals with chronic pain and spinal cord injury (SCI). Methods Descriptive statistics were calculated to investigate variable data distribution characteristics. Correlation analyses were conducted for convergent and discriminant validity. Item response theory-derived reliability was calculated for the SCI-QOL Resilience CAT. Result One hundred thirty-three adults with SCI ( N  = 133; 73.5% male, 26.5% female) were enrolled. Sample mean T score on the SCI-QOL Resilience measure was 48.40, SD = 8.60 (min = 29.4; max = 70.0). The CAT administered between 4 (most common, 41.4% of cases) and 12 (9% of cases) items with the Mean #items  = 5.73, SD = 2.45. The SCI-QOL Resilience CAT scores were normally distributed, with very low ceiling (0%) and floor (3%) effects. The SCI-QOL Resilience CAT had a reliability of 0.89, and the mean length of time for respondents to complete the SCI-QOL Resilience CAT was 44.34 s. SCI-QOL Resilience CAT validity was supported by significant moderate correlations with pain acceptance, depressive symptoms, pain catastrophizing, positive affect and well-being, and pain interference (convergent validity) and small non-significant correlations with age, sex, injury level, pain intensity, mobility level, and years since injury (discriminant validity). Conclusion The SCI-QOL Resilience CAT demonstrated good convergent and discriminant validity. The CAT administration characteristics were impressive: With few items (low response burden), the scale achieved good reliability.

Purpose The purpose of this study was to develop a new measure, the Re-Engineered Discharge for Diabetes Computer Adaptive Test (REDD-CAT) Illness Burden item bank, to evaluate the impact that a chronic condition has on independent living, the ability to work (including working at home), social activities, and relationships. Methods Semi-structured interviews were used to inform the development of an item pool (47 items) that captured patients’ beliefs about how a diagnosis of type 2 diabetes interferes with different aspects of their lives. The Illness Burden item bank was developed and tested in 225 people with type 2 diabetes mellitus. Results No items had sparse response option cells or problems with monotonicity; two items were deleted due to low item-rest correlations. Factor analyses supported the retention of 29 items. With those 29 remaining items, a constrained (common slope) graded response model fit assessment indicated that two items had misfit; they were excluded. No items displayed differential item functioning by age, sex, education, or socio-economic status. The final item bank is comprised of 27 items. Preliminary data supported the reliability (internal consistency and test–retest reliability) and validity (convergent, discriminant, and known-groups) of the new bank. Conclusion The Illness Burden item bank can be administered as a computer adaptive test or a 6-item short form. This new measure captures patients’ perceptions of the impact that having type 2 diabetes has on their daily lives; it can be used in conjunction with the REDD-CAT measurement system to evaluate important social determinants of health in persons with type 2 diabetes mellitus.