@article{6b1480a8d84f4970a8e8ca945d6ede4d,
title = "Investigating gender-based differential item functioning on the Kansas City Cardiomyopathy Questionnaire (KCCQ) using qualitative content analysis",
abstract = "Purpose: The purpose of this study is to evaluate potential gender-based differences in interpreting the Kansas City Cardiomyopathy Questionnaire (KCCQ-23) and to explore if there are aspects of health-related quality of life (HRQOL) not captured by the KCCQ-23 that are important to assess in men and/or women with heart failure (HF). Methods: Patients ≥ 22 years of age with clinician-diagnosed HF and left ventricular ejection fraction ≤ 40% were recruited from two academic medical centers to participate in semi-structured concept elicitation and cognitive debriefing interviews. Enrollment was stratified by patient-identified gender (half women/half men). All interviews were conducted over the phone/web and audio recorded. Interviews were transcribed and descriptive qualitative content analysis was used to summarize findings overall and by gender. Results: Twenty-five adults (56% women) diagnosed with HF participated. The average age was 67 years (range: 25–88). Women attributed a wider variety of symptoms to HF than men. Some participants had difficulty differentiating whether their experiences were due to HF, side effects of their medications, or age. We found very little evidence that participants interpreted KCCQ-23 items differently based on gender. Conclusions: Overall, our findings indicate that interpretation of the KCCQ-23 items were similar in men and women. However, some modifications to items may improve clarity of interpretation for a wide range of patients.",
keywords = "Differential item functioning, Heart failure, Patient-reported outcomes, Qualitative, Women",
author = "Coles, {Theresa M.} and Nicole Lucas and Molly McFatrich and Debra Henke and Ridgeway, {Jennifer L.} and Behnken, {Emma M.} and Kevin Weinfurt and Reeve, {Bryce B.} and Amy Corneli and Dunlay, {Shannon M.} and Spertus, {John A.} and Li Lin and Pi{\~n}a, {Ileana L.} and Bocell, {Fraser D.} and Tarver, {Michelle E.} and Heidi Dohse and Anindita Saha and Brittany Caldwell",
note = "Funding Information: JS owns the copyright to the KCCQ and receives license fees for the KCCQ. JS receives consulting fees from Bayer, Imbria Pharmaceuticals, Merck, Novartis, Bristol Meyers Squibb, Janssen, Terumo, and United Healthcare. JS is supported in grants from Abbott Vascular, Janssen and Bristol Meyers Squibb, and is on the Board of Directors for Blue Cross Blue Shield of Kansas City. RM received research support and honoraria from Abbott, American Regent, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim/Eli Lilly, Boston Scientific, Cytokinetics, Fast BioMedical, Gilead, Innolife, Medtronic, Merck, Novartis, Relypsa, Respicardia, Roche, Sanofi, Vifor, and Windtree Therapeutics. TC received research support from Merck and has a consulting agreement with Regenxbio. LL, KW, BR, IP, FB, MT, AS, DH, and BC have no competing interests to disclose. Funding Information: This work was supported by the U.S. Food & Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) Office of Women{\textquoteright}s Health and the Patient Science & Engagement Program within the FDA{\textquoteright}s Center for Devices and Radiological Health (Contract 75F40119C10080), and as part of a financial assistance award [Center of Excellence in Regulatory Science and Innovation grant to Yale University and Mayo Clinic, U01FD005938] funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government. Publisher Copyright: {\textcopyright} 2022, The Author(s), under exclusive licence to Springer Nature Switzerland AG.",
year = "2023",
month = mar,
doi = "10.1007/s11136-022-03276-y",
language = "English (US)",
volume = "32",
pages = "841--852",
journal = "Quality of Life Research",
issn = "0962-9343",
publisher = "Springer Netherlands",
number = "3",
}