A Systematic Review and Quality Assessment of Cardiovascular Disease-Specific Health-Related Quality-of-Life Instruments Part I: Instrument Development and Content Validity

Xue Li; Rui Li; Meixuan Li; Liang Yao; Harriette Van Spall; Kun Zhao; Yunxiang Chen; Feiyi Xiao; Qiang Fu; Feng Xie

doi:10.1016/j.jval.2024.04.001

A Systematic Review and Quality Assessment of Cardiovascular Disease-Specific Health-Related Quality-of-Life Instruments Part I: Instrument Development and Content Validity

Value Health. 2024 Apr 11:S1098-3015(24)02331-3. doi: 10.1016/j.jval.2024.04.001. Online ahead of print.

Authors

Xue Li¹, Rui Li², Meixuan Li³, Liang Yao⁴, Harriette Van Spall⁵, Kun Zhao⁶, Yunxiang Chen⁷, Feiyi Xiao⁸, Qiang Fu⁸, Feng Xie⁹

Affiliations

¹ Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada; Department of Health Technology Assessment, China National Health Development Research Center, Beijing, China.
² Department of Health Technology Assessment, China National Health Development Research Center, Beijing, China; Evidence Based Social Science Research Center/Health Technology Assessment Center, School of Public Health, Lanzhou University, Lanzhou, Gansu, China; Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, Gansu, China.
³ Evidence Based Social Science Research Center/Health Technology Assessment Center, School of Public Health, Lanzhou University, Lanzhou, Gansu, China; Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, Gansu, China.
⁴ Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.
⁵ Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada; Research Institute of St Joseph's and Population Health Research Institute, Hamilton, ON, Canada.
⁶ Department of Health Technology Assessment, China National Health Development Research Center, Beijing, China; Vanke School of Public Health, Tsinghua University, Beijing, China.
⁷ Department of Library, Shengjing Hospital, China Medical University, Shenyang, Liaoning, China.
⁸ Department of Health Technology Assessment, China National Health Development Research Center, Beijing, China.
⁹ Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada; Center for Health Economics and Policy Analysis, McMaster University, Hamilton, ON, Canada. Electronic address: fengxie@mcmaster.ca.

PMID: 38608875
DOI: 10.1016/j.jval.2024.04.001

Abstract

Objectives: Health-related quality-of-life (HRQoL) instruments for cardiovascular diseases (CVD) have been commonly used to measure important patient-reported outcomes (PROs) in clinical trials and practices. This study aimed at systematically identifying and assessing the content validity of CVD-specific HRQoL instruments in clinical studies.

Methods: The research team searched Cumulative Index to Nursing and Allied Health Literature, Embase, and PubMed from inception to January 20, 2022. The research team included studies that reported the development and content validity for CVD-specific instruments. Two reviewers independently assessed the methodological quality using the Consensus-based Standards for the Selection of Health Measurement Instruments methods on evaluating content validity of PROs. Content analysis was used to categorize the items included in the instruments.

Results: The research team found 69 studies reporting the content validity of 40 instruments specifically developed for CVD. Fourteen (35.0%) were rated "sufficient" with very low to moderate quality of evidence. For PRO development, all instruments were rated "doubtful" or "inadequate." Twenty-eight (70.0%) instruments cover the core concepts of HRQoL.

Conclusions: The quality of development and content validity vary among existing CVD-specific instruments. The evidence on the content validity should be considered when choosing a HRQoL instrument in CVD clinical studies and health economic evaluations.

Keywords: cardiovascular diseases; content validity; health-related quality of life; patient-reported outcomes.

Publication types

Review