In the United States, HIV has evolved from an acute disease to a chronic illness making health-related quality of life a pre-eminent goal for many persons living with HIV (PLWH). There have been a number of HIV-specific quality-of-life instruments developed, but little attention has been paid to the validation of standardized nondisease-specific quality-of-life instruments tailored to PLWH. The...

PROMIS (Patient-Reported-Outcomes Measurement Information System) is an NIH Roadmap network project intended to improve the reliability, validity, and precision of PROs and to provide definitive new instruments that will exceed the capabilities of classic instruments and enable improved outcome measurement for clinical research across all NIH institutes. Item response theory (IRT) measurement m...

BACKGROUND The EuroQol 5 dimensions questionnaire (EQ-5D), Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Global Health, and Veterans RAND 12-Item Health Survey (VR-12) are generic patient-reported outcome (PRO) questionnaires that assess a patient's general health. In choosing a PRO to track general health status, it is necessary to consider which measure will be the most...

INTRODUCTION Disability and Physical Function (PF) outcome assessment has had limited ability to measure functional status at the floor (very poor functional abilities) or the ceiling (very high functional abilities). We sought to identify, develop and evaluate new floor and ceiling items to enable broader and more precise assessment of PF outcomes for the NIH Patient-Reported-Outcomes Measurem...

BACKGROUND Integrative medicine (IM) provides patient-centered care and addresses the full range of physical, emotional, mental, social, spiritual, and environmental influences that affect a person's health. IM is a "whole systems" approach that employs multiple modalities as opposed to an isolated complementary therapy. Thus, studying outcomes of IM is more challenging than evaluating an isola...

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Adverse event (AE) reporting is a critical component of all cancer clinical trials, and the National Cancer Institute's Common Terminology Criteria for Adverse Events™ (CTCAE) is the primary system used by clinicians to describe the severity of AEs. The National Cancer Institute's Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE) assesses patient self-reports of symptoms using a Web-ba...

The aims of this paper are to present findings related to differential item functioning (DIF) in the Patient Reported Outcome Measurement Information System (PROMIS) depression item bank, and to discuss potential threats to the validity of results from studies of DIF. The 32 depression items studied were modified from several widely used instruments. DIF analyses of gender, age and education we...

Evaluation of clinical genetics services (CGS), including genetic counseling and genetic testing, has been problematic. Patient mortality and morbidity are unlikely to be directly improved by interventions offered in CGS. Patient-reported outcomes (PROs) are not routinely measured in CGS evaluation, but this may change as patient-reported outcome measures (PROMs) become a key part of how health...