The authors report on the development and calibration of item banks for depression, anxiety, and anger as part of the Patient-Reported Outcomes Measurement Information System (PROMIS®). Comprehensive literature searches yielded an initial bank of 1,404 items from 305 instruments. After qualitative item analysis (including focus groups and cognitive interviewing), 168 items (56 for each construct) were written in a first person, past tense format with a 7-day time frame and five response options reflecting frequency. The calibration sample included nearly 15,000 respondents. Final banks of 28, 29, and 29 items were calibrated for depression, anxiety, and anger, respectively, using item response theory. Test information curves showed that the PROMIS item banks provided more information than conventional measures in a range of severity from approximately −1 to +3 standard deviations (with higher scores indicating greater distress). Short forms consisting of seven to eight items provided information comparable to legacy measures containing more items.

We report on the development of short forms from the Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance (SD) and Sleep-Related Impairment (SRI) item banks. Results from post-hoc computerized adaptive testing (CAT) simulations, item discrimination parameters, item means, and clinical judgment were used to select the best-performing 8 items for SD and SRI. The final 8-item short forms provided less test information than the corresponding full banks, but correlated strongly with the longer forms. The short forms had greater measurement precision than the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS) as indicated by larger test information values across the continuum of severity, despite having fewer total items, a major advantage for both research and clinical settings.

The PROMIS sleep disturbance and SRI item banks have excellent measurement properties and may prove to be useful for assessing general aspects of sleep and SRI with various groups of patients and interventions.

A plausible factorial structure for many types of psychological and educational tests exhibits a general factor and one or more group or method factors. This structure can be represented by a bifactor model. The bifactor structure results from the constraint that each item has a nonzero loading on the primary dimension and, at most, one of the group factors. The authors develop estimation procedures for fitting the graded response model when the data follow the bifactor structure. Using maximum marginal likelihood estimation of item parameters, the bifactor restriction leads to a major simplification of the likelihood equations and (a) permits analysis of models with large numbers of group factors, (b) permits conditional dependence within identified subsets of items, and (c) provides more parsimonious factor solutions than an unrestricted full-information item factor analysis in some cases. Analysis of data obtained from 586 chronically mentally ill patients revealed a clear bifactor structure.

Purpose Symptomatic adverse events (AEs) are monitored by clinicians as part of all US-based clinical trials in cancer via the U.S. National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) for the purposes of ensuring patient safety. Recently there has been a charge toward capturing the patient perspective for those AEs amenable to patient self-reporting via patient-reported outcomes (PRO). The aim of this review was to summarize the empirically reported association between analogous CTCAE and PRO ratings. Methods A systematic literature search was conducted using PubMed, EMBASE, Web of Science, and Cochrane databases through July 2015. From a total of 5,658 articles retrieved, 28 studies met inclusion criteria. Results Across studies, patients were of mixed cancer types, including anal, breast, cervical, chronic myeloid leukemia, endometrial, hematological, lung, ovarian, pelvic, pharyngeal, prostate and rectal. Given this mixture, the AEs captured were variable, with many common across studies (e.g., dyspnea, fatigue, nausea, neuropathy, pain, vomiting), as well as several that were disease-specific (e.g., erectile dysfunction, hemoptysis). Overall, the quantified association between CTCAE and PRO ratings fell in the fair to moderate range and had large variation across the majority of studies (n = 21). Conclusions The range of measures used and symptoms captured varied greatly across the reviewed studies. Regardless of concordance metric employed, reported agreement between CTCAE and PRO ratings was moderate at best. To assist with reconciliation and interpretation of these differences toward ultimately improving patient care, an important next step is to explore approaches to integrate PROs with clinician reporting of AEs.