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Combining online and in-person methods to evaluate the content validity of PROMIS fatigue short forms in rheumatoid arthritis

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Abstract

Purpose

Fatigue is frequent and often severe and disabling in RA, and there is no consensus on how to measure it. We used online surveys and in-person interviews to evaluate PROMIS Fatigue 7a and 8a short forms (SFs) in people with RA.

Methods

We recruited people with RA from an online patient community (n = 200) and three academic medical centers (n = 84) in the US. Participants completed both SFs then rated the comprehensiveness and comprehensibility of the items to their fatigue experience. Cognitive debriefing of items was conducted in a subset of 32 clinic patients. Descriptive statistics were calculated, and associations were evaluated using Pearson and Spearman correlation coefficients.

Results

Mean SF scores were similar (p ≥ .61) among clinic patients reflecting mild fatigue (i.e., 54.5–55.9), but were significantly higher (p < .001) in online participants. SF Fatigue scores correlated highly (r ≥ 0.82; p < .000) and moderately with patient assessments of disease activity (r ≥ 0.62; p = .000). Most (70–92%) reported that the items “completely” or “mostly” reflected their experience. Almost all (≥ 94%) could distinguish general fatigue from RA fatigue. Most (≥ 85%) rated individual items questions as “somewhat” or “very relevant” to their fatigue experience, averaged their fatigue over the past 7 days (58%), and rated fatigue impact versus severity (72 vs. 19%). 99% rated fatigue as an important symptom they considered when deciding how well their current treatment was controlling their RA.

Conclusions

Results suggest that items in the single-score PROMIS Fatigue SFs demonstrate content validity and can adequately capture the wide range of fatigue experiences of people with RA.

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Acknowledgements

The authors would like to thank research teams at Johns Hopkins, Hospital for Special Surgery, and University of Alabama at Birmingham for their assistance (Michelle Jones, Bernadette Johnson, Kathleen Andersen, Jessica Ashley), and the rheumatologists and trainees who referred patients for participation in the studies. We gratefully acknowledge assistance from Global Healthy Living Foundation for access to an online arthritis patient community through CreakyJoints.org and technical support from David Curtis. We thank members of our external advisory group to this project, including our patient research partners Ms. Amye Leong and Ms. Anne Lyddiatt, in addition to Dr. James Witter and Dr. April Naegeli.

Disclosures

Dr. Bartlett is an unpaid non-voting member of the RA Working Group of the C-Path PRO Consortium and is an unpaid member of the steering committees for PROMIS International, the OMERACT Drug Safety Group, the Scleroderma Patient-centered Interventions Network (SPIN), Cancer Care Ontario, and Canada-PRO. She has served as a consultant to Eli Lilly, Janssen, Pfizer, Merck, and UCB in the area of patient-reported outcomes. Dr. Bykerk has consulted for Amgen, BMS, Pfizer, Sanofi/Regeneron, Gilead, and UCB; she has participated in advisory boards for Amgen, BMS, Pfizer, Sanofi/Regeneron, Gilead. Amgen, BMS, UCB have funded studies that are being or were recently performed at HSS where Dr. Bykerk is or was an investigator or principle investigator or site principle investigator on these studies. Dr. Orbai received research funding to Johns Hopkins University from Celgene, Eli Lilly, Horizon, Janssen, Novartis, and Pfizer. Dr. Orbai received consulting fees from participating in advisory boards for Eli Lilly, Janssen, Novartis, Pfizer, and UCB. Dr. Bingham is an unpaid non-voting member of the RA Working Group of the C-Path PRO Consortium and is an unpaid member of the executive committee of OMERACT (Outcome Measures in Rheumatology) which has been funded by arm’s length funding from 32 pharmaceutical companies and research organizations. He has served as a consultant to Eli Lilly, Janssen, Pfizer, and UCB in the area of patient-reported outcomes. All other authors declare that he/she has no conflict of interest.

Funding

The primary research data included within this report were acquired as part of projects funded in part from the Patient-Centered Outcomes Research Institute (PCORI) through a PCORI Methods Award (SC14-1402-10818). This work was also supported by the National Institutes of Health (NIH) through the Rheumatic Diseases Resource-based Core Center (P30-AR053503 Cores A and D, and P30-AR070254, Cores A and B), a research agreement from the Critical Path Institute (C-Path) to Johns Hopkins, and the Camille Julia Morgan Arthritis Research and Education Fund. All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of PCORI, its Board of Governors or Methodology Committee, of the NIH or the National Institute of Arthritis Musculoskeletal and Skin Diseases (NIAMS), or of the PROMIS Health Organization (PHO).

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Authors and Affiliations

  1. Center for Health Outcomes Research, McGill University, 5252 de Maisonneuve West, #3D-57, Montreal, QC, H4A 3S5, Canada

    S. J. Bartlett

  2. Division of Rheumatology, Johns Hopkins School of Medicine, Mason F Lord Tower, 5200 Eastern Avenue, Rm 404, Baltimore, MD, 21224, USA

    S. J. Bartlett, A. K. Gutierrez, A. Butanis, A. M. Orbai & C. O. Bingham 3rd

  3. Ateneo School of Medicine and Public Health, Pasig City, Philippines

    A. K. Gutierrez

  4. Hospital for Special Surgery, Weill Cornell Medical College, 525 East 71st St, 7th floor, New York, NY, 10021, USA

    V. P. Bykerk

  5. Division of Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA

    J. R. Curtis

  6. Global Healthy Living Foundation, Upper Nyack, NY, USA

    S. Ginsberg & W. B. Nowell

  7. Healthy Motivation, Santa Barbara, CA, USA

    A. L. Leong

  8. Patient Partners, London, ON, Canada

    A. Lyddiatt

  9. Johns Hopkins Bloomberg School of Public Health Center for Qualitative Studies in Health and Medicine, Baltimore, MD, USA

    K. C. Smith

Authors
  1. S. J. Bartlett
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  2. A. K. Gutierrez
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  3. A. Butanis
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  4. V. P. Bykerk
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  6. S. Ginsberg
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  7. A. L. Leong
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  8. A. Lyddiatt
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  9. W. B. Nowell
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  10. A. M. Orbai
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  11. K. C. Smith
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  12. C. O. Bingham 3rd
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Corresponding author

Correspondence to S. J. Bartlett.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Bartlett, S.J., Gutierrez, A.K., Butanis, A. et al. Combining online and in-person methods to evaluate the content validity of PROMIS fatigue short forms in rheumatoid arthritis. Qual Life Res 27, 2443–2451 (2018). https://doi.org/10.1007/s11136-018-1880-x

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