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

METHODS: CINAHL, Embase, and PubMed were systematically searched from inception to January 20, 2022. Studies that reported the development and content validity for CVD-specific instruments were included. The content analysis was used to analyze the constructs measured in the existing instruments. Two reviewers independently assessed the methodological quality using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) methods on evaluating content validity of PROs.

RESULTS: 69 studies reporting the development of 40 instruments were identified and included. All instruments were rated “doubtful” or “inadequate” on instrument development. 22 (55.0%) instruments reported evidence on content validity with rating of “doubtful”. The overall ratings of content validity for all instruments were moderate, and most evidence was of low or very low quality.

CONCLUSIONS: Of the 40 HRQoL instruments validated in CVDs, 14 were rated “sufficient” with moderate to very low quality of evidence. Given the use of HRQoL instruments to guide labeling claims of medical products in many countries, there is a need for better adherence to quality standards in HRQoL instruments development studies.