Series: Clinical Validity of PROMIS Measures Across Several Chronic Conditions
Original Article
PROMIS Fatigue Item Bank had Clinical Validity across Diverse Chronic Conditions

https://doi.org/10.1016/j.jclinepi.2015.08.037Get rights and content

Abstract

Objective

To evaluate the comparability and responsiveness of Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue item bank across six chronic conditions.

Study Design and Setting

Individuals (n = 1,430) with chronic obstructive pulmonary disease (n = 125), chronic heart failure (n = 60), chronic back pain (n = 218), major depressive disorder (n = 196), rheumatoid arthritis (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 before 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 standard deviation worse). The four clinical groups with pretreatment baseline data experienced significant improvement in fatigue at follow-up (effect size range = 0.25–0.91). 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.

Introduction

Fatigue is a symptom commonly experienced by healthy individuals as well as those with chronic disorders. When experienced as part of a chronic condition, it is often experienced as overwhelming, debilitating, and exhausting; decreasing one's ability to carry out daily activities, including the ability to work effectively and to function at one's usual level in family or social roles [1], [2], [3], [4]. A growing body of literature documents the high prevalence of fatigue and its impact across a variety of chronic heart failure, including back pain [5], cancer [6], [7], chronic heart failure (CHF) [8], chronic obstructive pulmonary disease (COPD) [9], major depressive disorder (MDD) [10], [11], and rheumatoid arthritis (RA) [12]. Its prevalence makes it a common treatment target, as relieving fatigue often results in improved well-being and function across a large number of people.

The World Health Organization (WHO)'s International Classification of Functioning, Disability and Health included the minimization of fatigue among its stated aims [13], highlighting the importance of regular assessment of fatigue in both research and clinical contexts. Although a number of disease-specific fatigue measures exist [14], [15], [16], [17], a well-developed and carefully calibrated universal fatigue measure that can be applied across chronic health populations and treatment contexts could enhance the comparability of findings and thus serve as a common metric of fatigue across chronic health condition groups. This would greatly enhance the interpretability of fatigue results across clinical research studies and enable meaningful comparative effectiveness research.

To this end, the Patient-Reported Outcomes Measurement Information System (PROMIS®) investigators used a multistep, mixed-methods approach to develop a fatigue item bank which can be used as an assessment tool as either a computerized adaptive test (CAT) or a fixed-length short form. The development process and psychometric properties of the fatigue item bank have been reported previously [18], [19], [20]. In this article, we describe the longitudinal clinical validation of the fatigue item bank in adults in six different chronic health condition samples: back pain, cancer, CHF, COPD, MDD, and RA. We hypothesized that these clinical samples would present with more fatigue than is found in the general US population. We also hypothesized that clinical samples with baseline (pretreatment) data available, who were embarking on a new or modified treatment plan (i.e., treatment for back pain; CHF; COPD patients in an acute exacerbation of symptoms; MDD), would experience longitudinal improvements in fatigue. We also predicted relative stability in fatigue scores over time among other clinical samples being followed naturalistically (i.e., COPD-stable patients; cancer; RA), or in clinical situations where some patients would be expected to improve, some would be expected to worsen, and many would not be expected to change (e.g., RA, stable COPD). Finally, we hypothesized that fatigue scores would differentiate subsets of samples that were distinct in terms of clinical severity or functional impairment (e.g., COPD stable versus COPD exacerbation).

Section snippets

Clinical samples

Included in this report are data collected across six studies (back pain, cancer, CHF, COPD, MDD, and RA), conducted by PROMIS investigators. The studies of MDD, back pain, and CHF followed patients as they enrolled in new treatments. Patients with acute COPD exacerbation were expected to experience symptom resolution over the course of the study. Both RA and cancer samples were heterogeneous with respect to intervention but were dominated by participants who were already receiving treatments

Participant characteristics

A total of 1,430 people participated in the clinical studies. Participants were diverse in terms of gender, age, and marital status, as reported in the overview article in this issue (this volume) (Cook et al., submitted data). Most participants were non-Hispanic white, had some college education, and had moderate to severe health limitations. At baseline, participants from all studies reported more fatigue, ranging from 2 to 13 T-score points (i.e., 0.2–1.3 SD on the T-score metric) higher

Discussion

The PROMIS fatigue item bank was developed using rigorous methods, demonstrates good psychometric properties, and is publicly available [18]. The present study extends the initial published information on reliability and validity by examining the longitudinal validation of the PROMIS fatigue item bank in six chronic conditions, thus providing support for the clinical validity of PROMIS fatigue measures. The findings also highlight the ability to meaningfully compare fatigue levels across

Acknowledgments

PROMIS was funded with cooperative agreements from the National Institutes of Health Common Fund Initiative (Northwestern University, PI: D.C., U54AR057951, U01AR052177, R01CA60068; Northwestern University, PI: Richard C. Gershon, PhD, U54AR057943; American Institutes for Research, PI: Susan (San) D. Keller, PhD, U54AR057926; State University of New York, Stony Brook, PIs: Joan E. Broderick, PhD and Arthur A. Stone, PhD, U01AR057948, U01AR052170; University of Washington, Seattle, PIs: Heidi M.

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    Conflicts of interest: D.C. is an unpaid member of the board of directors and officer of the PROMIS Health Organization. B.B.R. is an unpaid member of the board of directors of the PROMIS Health Organization. A.A.S. declares a potential conflict as senior scientist with the Gallup Organization and as a senior consultant with ERT, Inc.

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