PMID- 32680513 OWN - NLM STAT- MEDLINE DCOM- 20201006 LR - 20201006 IS - 1477-7525 (Electronic) IS - 1477-7525 (Linking) VI - 18 IP - 1 DP - 2020 Jul 17 TI - Psychometric properties of the Japanese version of the Kansas City Cardiomyopathy Questionnaire in Japanese patients with chronic heart failure. PG - 236 LID - 10.1186/s12955-020-01483-0 [doi] LID - 236 AB - BACKGROUND: Heart failure is a worldwide health problem that significantly affects patients' physical function and health state. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcome measure commonly used for the assessment of health states of patients with heart failure. This study aimed to evaluate the psychometric properties of the Japanese version of the KCCQ. METHODS: Using pooled data of 141 Japanese patients with chronic heart failure from three clinical trials, the Japanese version of the KCCQ was evaluated for validity and reliability, with a focus on the clinical summary score (CSS) and its component domains. For construct validity, the associations of baseline KCCQ scores with New York Heart Association (NYHA) class and the EuroQol five-dimension, three-level (EQ-5D-3L) scores at baseline were analyzed. For reliability, internal consistency was assessed using Cronbach's alpha, and test-retest reliability (reproducibility) was assessed among stable patients. Responsiveness to changes in patients' clinical status was assessed by analyzing score changes between two timepoints among patients whose health states improved. RESULTS: Among 141 patients (mean age, 73.7 +/- 10.9 years), 76.6% were NYHA class II at baseline. For CSS and its component domains (physical limitations, symptom frequency, and symptom severity), baseline scores were all significantly lower in patients with a higher NYHA class (p < 0.001 for all, Jonckheere-Terpstra test). The physical limitations domain and CSS showed a moderate correlation (Spearman's rho = - 0.40 to - 0.54) with three functional status-related EQ-5D dimensions (mobility, self-care, and usual activities). The Cronbach's standardized alpha was high (> 0.70) for all KCCQ domain/summary scores. In the test-retest analysis among 58 stable patients, all domain/summary scores minimally changed by 0.3-4.2 points with intraclass correlation coefficients of 0.65-0.84, demonstrating moderate to good reproducibility, except for the symptom stability domain. Among 44 patients with improved health states, all domain/summary scores except for the symptom stability and self-efficacy domains substantially improved from baseline with a medium to large effect size of 0.62-0.88. CONCLUSIONS: The Japanese version of the KCCQ was demonstrated to be a valid and reliable tool for the assessment of symptoms and physical function of Japanese patients with chronic heart failure. FAU - Watanabe-Fujinuma, Emi AU - Watanabe-Fujinuma E AD - Health Economics and Outcomes Research, Market Access, Bayer Yakuhin, Ltd., Tokyo, Japan. FAU - Origasa, Hideki AU - Origasa H AD - Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences, Toyama, Japan. FAU - Bamber, Luke AU - Bamber L AD - Bayer AG, Wuppertal, Germany. FAU - Roessig, Lothar AU - Roessig L AD - Bayer AG, Wuppertal, Germany. FAU - Toyoda, Tetsumi AU - Toyoda T AD - Clinical Study Support, Inc, Nagoya, Japan. FAU - Haga, Yuri AU - Haga Y AUID- ORCID: 0000-0002-0365-4478 AD - Clinical Study Support, Inc, Nagoya, Japan. yuri_haga@jp-css.com. FAU - Gwaltney, Chad AU - Gwaltney C AD - Gwaltney Consulting, Westerly, RI, USA. FAU - Pieske, Burkert AU - Pieske B AD - Department of Internal Medicine and Cardiology, Campus Virchow Klinikum, Charite University Medicine Berlin, Berlin, Germany. AD - Department of Internal Medicine and Cardiology, German Heart Center Berlin, Berlin, Germany. AD - DZHK (German Center for Cardiovascular Research), Berlin, Germany. AD - Berlin Institute of Health (BIH), Berlin, Germany. LA - eng PT - Journal Article PT - Validation Study DEP - 20200717 PL - England TA - Health Qual Life Outcomes JT - Health and quality of life outcomes JID - 101153626 SB - IM MH - Aged MH - Aged, 80 and over MH - Chronic Disease/psychology MH - Female MH - Heart Failure/*psychology MH - Humans MH - Japan MH - Male MH - Middle Aged MH - Patient Reported Outcome Measures MH - *Quality of Life MH - Reproducibility of Results MH - Surveys and Questionnaires/*standards PMC - PMC7368765 OTO - NOTNLM OT - Functional status OT - Heart failure OT - Japanese OT - Kansas City Cardiomyopathy Questionnaire OT - Psychometric properties COIS- EF is an employee of Bayer Yakuhin, Ltd. HO has received advisory fee from Bayer Yakuhin, Ltd. LB and LR are employees of Bayer AG. TT and YH are employees of Clinical Study Support, Inc. CG has received consulting fees from Bayer AG, Bayer HealthCare Pharmaceuticals, and Bayer Yakuhin, Ltd. BP has received research funds from Bayer Healthcare, Servier, and Astra-Zeneca, as well as speakers honoraria/committee membership fees from Novartis, Bayer Healthcare, Daiichi-Sankyo, MSD, Stealth Peptides, Astra-Zeneca, Sanofi, Vifor, and Servier. EDAT- 2020/07/19 06:00 MHDA- 2020/10/07 06:00 PMCR- 2020/07/17 CRDT- 2020/07/19 06:00 PHST- 2019/12/10 00:00 [received] PHST- 2020/07/08 00:00 [accepted] PHST- 2020/07/19 06:00 [entrez] PHST- 2020/07/19 06:00 [pubmed] PHST- 2020/10/07 06:00 [medline] PHST- 2020/07/17 00:00 [pmc-release] AID - 10.1186/s12955-020-01483-0 [pii] AID - 1483 [pii] AID - 10.1186/s12955-020-01483-0 [doi] PST - epublish SO - Health Qual Life Outcomes. 2020 Jul 17;18(1):236. doi: 10.1186/s12955-020-01483-0.