@article{1ece3f6b24744f4f984161fc6513f62e,
title = "Combining online and in-person methods to evaluate the content validity of PROMIS fatigue short forms in rheumatoid arthritis",
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.",
keywords = "Content validity, Fatigue, PROMIS, Rheumatoid arthritis",
author = "Bartlett, {S. J.} and Gutierrez, {A. K.} and A. Butanis and Bykerk, {V. P.} and Curtis, {J. R.} and S. Ginsberg and Leong, {A. L.} and A. Lyddiatt and Nowell, {W. B.} and Orbai, {A. M.} and Smith, {K. C.} and Bingham, {C. O.}",
note = "Funding Information: 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 OMER-ACT 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{\textquoteright}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 Information: 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. 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. Publisher Copyright: {\textcopyright} 2018, Springer International Publishing AG, part of Springer Nature.",
year = "2018",
month = sep,
day = "1",
doi = "10.1007/s11136-018-1880-x",
language = "English (US)",
volume = "27",
pages = "2443--2451",
journal = "Quality of Life Research",
issn = "0962-9343",
publisher = "Springer Netherlands",
number = "9",
}