PROMIS Fatigue Item Bank had Clinical Validity across Diverse Chronic Conditions

Abstract

Objective To evaluate the comparability and responsiveness of PROMIS Fatigue Item Bank across six chronic conditions. Study Design and Setting Individuals (n=1,430) with chronic obstructive pulmonary disease (COPD; n=125), chronic heart failure (CHF; n=60), chronic back pain (n=218), major depressive disorder (MDD; n=196), rheumatoid arthritis (RA; n=521), and cancer(n=310) completed assessments from the PROMIS fatigue item bank at baseline and a clinically-relevant follow-up. The cancer and arthritis samples were followed in observational studies; the other four groups were enrolled immediately prior to a planned clinical intervention. All participants completed global ratings of change at follow-up. Linear mixed effects models and standardized response means were estimated to examine clinical validity and responsiveness to change. Results All patient groups reported more fatigue than the general population (range = 0.2 – 1.29 SD worse). The four clinical groups with pre-treatment baseline data experienced significant improvement in fatigue at follow-up (effect size range= 0.25 to 0.91). Individuals reporting better overall health usually experienced larger fatigue changes than those reporting worse overall health. Conclusion The results support the PROMIS fatigue measures’s responsiveness to change in six different chronic conditions. In addition, these results support the ability of the PROMIS fatigue measures to compare differences in fatigue across a range of chronic conditions, thereby enabling comparative effectiveness research.

PROMIS and legacy measures compared in a supportive care intervention for breast cancer patients and caregivers: Experience from a randomized trial

“…In this study, the shortest PROMIS‐29 Profile v1.0 is compared with a collection of instruments of similar conceptual content but created prior to the PROMIS initiative and referred to as legacy measures. The legacy measures used in the initial PROMIS development and validation studies included the Medical Outcomes Study Short Form 36 (SF‐36), the Center for Epidemiologic Studies‐Depression (CESD) scale, the State Anxiety scale, and the Pittsburgh Sleep Symptom Questionnaire‐Insomnia (PSSQ_I). In this study, the M.D.…”

“…While extensive evidence on the validity of PROMIS tools is available, their responsiveness, ie, the ability to discriminate groups, is beginning to be addressed in observational studies involving clinical populations . However, evidence of responsiveness of PROMIS measures from randomized controlled trials (RCTs) is lacking, with the exception of measures of pain interference in populations of patients with musculoskeletal pain or among stroke survivors .…”

“…This set of legacy measures includes disease-general and disease-specific tools that have either longer or shorter length compared with the 4-item short forms that comprise PROMIS-29 Profile. 1 While extensive evidence on the validity of PROMIS tools is available, [2][3][4]6 their responsiveness, ie, the ability to discriminate groups, is beginning to be addressed in observational studies involving clinical populations. [7][8][9][10][11] However, evidence of responsiveness of PROMIS measures from randomized controlled trials (RCTs) is lacking, with the exception of measures of pain interference in populations of patients with musculoskeletal pain or among stroke survivors.…”

Performance of the Patient‐Reported Outcomes Measurement Information System 29‐Item Profile in Rheumatoid Arthritis, Osteoarthritis, Fibromyalgia, and Systemic Lupus Erythematosus

“…To date, a number of researchers have examined the psychometric properties of PROMIS measures in rheumatic conditions, with the largest concentration of work on the physical functioning measures, both CAT and static forms, in RA . More recently, the psychometric performance of other CAT and static scales have been examined in RA , and PROMIS measures are beginning to be explored in other rheumatic conditions .…”

Estimates of Responsiveness, Minimally Important Differences, and Patient Acceptable Symptom State in Five Patient‐Reported Outcomes Measurement Information System Short Forms in Systemic Lupus Erythematosus

“…Standardized response means (SRMs) (mean change/SD of change) and effect sizes (ESs) (mean change/SD of baseline) were calculated for the worse and better groups (10,30). Assignments to worse, same, and better anchor groups were independent across change periods.…”