Validity of PROMIS physical function measured in diverse clinical samples

Abstract

Objective To evaluate the validity of the PROMIS® Physical Function measures using longitudinal data collected in six chronic health conditions. Study Design and Setting Individuals with rheumatoid arthritis (RA), major depressive disorder (MDD), back pain, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF), and cancer completed the PROMIS Physical Function computerized adaptive test (CAT) or fixed-length short form (SF) at baseline and at the end of clinically-relevant follow-up intervals. Anchor items were also administered to assess change in physical function and general health. Linear mixed effects models and standardized response means were estimated at baseline and follow-up. Results 1415 individuals participated (COPD n = 121; CHF n = 57; back pain n = 218; MDD n = 196, RA n = 521; cancer n = 302). The PROMIS Physical Function scores improved significantly for treatment of CHF and back pain patients, but not for patients with MDD or COPD. Most of the patient subsamples that reported improvement or worsening on the anchors showed a corresponding positive or negative change in PROMIS Physical Function. Conclusion This study provides evidence that the PROMIS Physical Function measures are sensitive to change in intervention studies where physical function is expected to change and able to distinguish among different clinical samples. The results inform the estimation of meaningful change, enabling comparative effectiveness research.

Treatment‐associated toxicities reported by patients with early‐stage invasive breast cancer

“…To measure physical health, we used the 4‐item physical function subscale of the Patient Reported Outcomes Measurement Information System (PROMIS) global health measure. The scale is a brief, valid, reliable, precise, and clinically interpretable measure of physical health . Respondents rated each item on a 5‐point ordinal scale.…”

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 .…”

Physical function and pain intensity in patients with metastatic bone disease

“…Jensen et al demonstrated that physical function decreases with worse cancer stages, in line with the finding in our study that patients with bone metastases have a poor function. Physical function of patients with bone metastases is comparable to patients with COPD (mean: 38), congestive heart failure (mean: 35), and back pain (mean: 38), but worse than patients with rheumatoid arthritis (mean: 41), and major depressive disorder (mean: 47) . The slightly less pain among patients with bone metastases in this study as compared to the US general population (PROMIS) might be explained by the skewed distribution of our sample; 27 patients (13%) had the lowest possible pain intensity score (ie, no pain), which lowers the mean.…”

“…Based on these subanalyses, and the fact that possible confounders were accounted for in the multivariable analysis (by including explanatory variables with a P value below .10) we do not feel that confounding played a major role in the association of primary tumor type with physical function and pain. A strength of this study is the use of validated patient reported outcome measures that have adequately been tested for validity in the population under study . Fourth, the correlation between pain intensity and physical function does not imply causation; we, therefore, cannot conclude that reducing pain would improve physical function or vice versa.…”