A comparison of the EQ-5D-5L and the SF-6Dv2 among patients with hypertrophic obstructive cardiomyopathy

medrxiv(2023)

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摘要
Background Hypertrophic obstructive cardiomyopathy (HOCM) is a serious and complex chronic disease severely affecting patients’ daily lives and health-related quality of life (HRQoL). The psychometric performance of generic preference-based instruments has not been compared in Chinese patients with HOCM. We aimed to identify an applicable vehicle to determine HRQoL and explore the psychometric properties of SF-6Dv2 and EQ- 5D-5L in adults with HOCM. The interchangeability of the tools in cost-utility analysis was also investigated. Methods We collected data from 131 patients with HOCM from the First Affiliated Hospital of Zhengzhou University, China. Assessments were performed on the day of admission and three and six months after discharge using SF-6Dv2 and EQ-5D-5L. The responses were converted to utility values using the corresponding Chinese value sets. The tool distributions were explored, and the floor and ceiling effects were analyzed. The agreement was assessed using intra-class correlation coefficients (ICCs) and Bland–Altman plots. Convergent validity was tested using Spearman’s rank correlation coefficient. Known group validity was measured across various clinical and sociodemographic indicators using relative efficiency (RE) statistics. Results The mean utility scores for SF-6Dv2 and EQ-5D- 5L at baseline and 6-month follow-up were 0.61, 0.62, 0.736, and 0.797, respectively. The EQ-5D-5L and SF-6Dv2 distribution scores showed no normality. EQ-5D-5L was more sensitive to changes over time and showed a moderate to good correlation with the SF-6Dv2 (ICC: 0.598–0.862). The instruments’ agreement and convergent validity worsened in patients with a higher New York Heart Association (NYHA) cardiac function classification and lower general health status. SF-6Dv2 showed higher relative efficiency statistics and a greater ability to distinguish external health status. Conclusions The measured results can be used for future cost-utility analyses. SF-6Dv2 and EQ-5D-5L presented different results and should not be used interchangeably. SF-6Dv2 is optimal for detecting differences between subgroups with various health states. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement The author(s) received no specific funding for this work. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study protocol was approved by the University of Zhengzhou Ethics Committee (registration number 2021-KY-0943-002). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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