Purpose The Patient-Reported Outcomes Measurement Information System (PROMIS) aims to develop self-reported item banks for clinical research. The PROMIS pediatrics (aged 8–17) project focuses on the development of item banks across several health domains (physical function, pain, fatigue, emotional distress, social role relationships, and asthma symptoms). The psychometric properties of the anxiety and depressive symptom item banks are described. Methods Participants (n = 1,529) were recruited in public school settings, hospital-based outpatient and subspecialty pediatrics clinics. The anxiety (k = 18) and depressive symptoms (k = 21) items were split between two test administration forms. Hierarchical confirmatory factor-analytic models (CFA) were conducted to evaluate scale dimensionality and local dependence. IRT analyses were then used to finalize item banks and short forms. Results CFA results confirmed that anxiety and depressive symptoms are separate constructs and indicative of negative affect. Items with local dependence and DIF were removed resulting in 15 anxiety and 14 depressive symptoms items. The psychometric differences between short forms and simulated computer adaptive tests are presented. Conclusions PROMIS pediatric item banks were developed to provide efficient assessment of health-related quality of life domains. This sample provides initial calibrations of anxiety and depressive symptoms item banks and creates PROMIS pediatric instruments, version 1.0.

Objective-To create self-report physical function (PF) measures for children using modern psychometric methods for item analysis as part of Patient Reported Outcomes Measurement Information System (PROMIS).Study Design and Setting-PROMIS qualitative methodology was applied to develop two PF item pools comprised of 32 mobility and 38 upper extremity items. Items were computer administered to subjects aged 8-17 years. Scale dimensionality and sources of local dependence (LD) were evaluated with factor analysis. Items were analyzed for differential item functioning (DIF) between genders. Items with LD, DIF, or low discrimination were considered for removal. Computerized adaptive testing performance was simulated, and short forms were constructed.Results-3,048 children (51.8% female, 40% non-white, 22.7% chronically ill) participated. At least 754 respondents answered each item. Factor analytic results confirmed two dimensions of PF. Fifty-two of 70 items tested were retained. A 23 item mobility bank and a 29 item upper extremity bank resulted, and 8 item short forms were created. The item banks have high information from the population mean to 3 standard deviations below. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. The Patient Reported Outcomes Measurement Information System (PROMIS) was created through a National Institutes of Health initiative to improve patient reported outcomes (PRO) assessment (1). PROMIS uses modern psychometric methods, including item response theory (IRT), to construct item banks from which static short forms or computerized adaptive tests (CAT) may be created to measure outcomes in a more efficient and precise manner than is possible using classical test theory(2). We describe the development of PROMIS physical function (PF) scales for pediatrics. Conclusions-PROMIS NIH Public AccessItem banks developed to satisfy the assumptions of IRT offer several advantages related to the measurement properties of IRT. Necessary conditions for item bank development are unidimensionality, that a scale measures a single underlying construct, lack of local dependence (LD), or that items share no covariance beyond that of the underlying construct, and lack of differential item functioning (DIF), meaning that people from different groups, (e.g., age, gender) who have a given level of an underlying trait, have the same probability of a given response. IRT based scales include the property of interval level scaling for better interpretation of change, calibration of items across a broad range of an underlying trait to overcome floor/ceiling effects, increas...

Objective This study’s objective was to develop a measure of social health using item response theory as part of the Patient Reported Outcomes Measurement Information System (PROMIS). Methods After candidate items were generated from review of prior literature, focus groups, expert input, and cognitive interviews, items were administered to youth aged 8–17 as part of the PROMIS pediatric large scale testing. Exploratory and confirmatory factor analyses were used to assess dimensionality and to identify instances of local dependence. Items that met the unidimensionality criteria were subsequently calibrated using Samejima’s Graded Response Model. Differential item functioning was examined by gender and age. Results The sample included 3,048 youth who completed the questionnaire (51.8% female, 60% white, and 22.7% with chronic illness). The initial conceptualization of social function and sociability did not yield unidimensional item banks. Rather, factor analysis revealed dimensions contrasting peer relationships and adult relationships. The analysis also identified dimensions formed by responses to positively versus negatively worded items. The resulting 15-item bank measures quality of peer relationships and has strong psychometric characteristics as a full bank or an 8-item short form. Conclusions The PROMIS pediatric peer relationships scale demonstrates good psychometric characteristics and addresses an important aspect of child health.

Purpose: To evaluate the reliability and validity of six PROMIS measures (anxiety, depression, fatigue, pain interference, physical function, sleep disturbance) telephone-administered to a diverse, population-based cohort of localized prostate cancer patients. Methods: Newly-diagnosed men were enrolled in the North Carolina Prostate cancer Comparative Effectiveness and Survivorship Study. PROMIS measures were telephone-administered pre-treatment (baseline), and at 3-months and 12-months post-treatment initiation (N=778). Reliability was evaluated using Cronbach’s alpha. Dimensionality was examined with bifactor models and explained common variance (ECV). Ordinal logistic regression models were used to detect potential differential item functioning (DIF) for key demographic groups. Convergent and discriminant validity were assessed by correlations with the legacy instruments Memorial Anxiety Scale for Prostate Cancer and SF-12v2. Known-groups validity was examined by age, race/ethnicity, comorbidity, and treatment. Results: Each PROMIS measure had high Cronbach’s alpha values (0.86 to 0.96) and was sufficiently unidimensional. Floor effects were observed for anxiety, depression, and pain interference measures; ceiling effects were observed for physical function. No DIF was detected. Convergent validity was established with moderate to strong correlations between PROMIS and legacy measures (0.41 to 0.77) of similar constructs. Discriminant validity was demonstrated with weak correlations between measures of dissimilar domains (−0.20 to −0.31). PROMIS measures detected differences across age, race/ethnicity, and comorbidity groups; no differences were found by treatment. Conclusions: This study provides support for the reliability and construct validity of six PROMIS measures in prostate cancer, as well as the utility of telephone administration for assessing HRQoL in low literacy and hard-to-reach populations.