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

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.

Health Technology Assessment in China's Health Care Sector: Development and Applications.

China's health system is facing severe challenges from social transition and the double burden of population aging and non-communicable diseases. Addressing the tension between the public's increasing demand for health services and the limited availability of medical resources has become a critical issue for health care policymakers and medical insurance fund administrators. In promoting its medical insurance system reform, China is actively developing health technology assessment (HTA) with principles and applications adapted to the Chinese context. This study aims to analyze the evolution of HTA in China with a focus on context, actors, process, content, and challenges encountered through applying a modified verson of Walt and Gilson's policy triangle framework. Currently, HTA plays an indispensable part in the reform of China's health care and medical insurance system, especially in the formulation and adjustment of the National Reimbursement Drug List (NRDL). While HTA is increasingly used in China, there remain challenges, such as the slow development of HTA related disciplines, lack of an independent national HTA authority, and limited scope in the use of HTA. Despite the identified challenges, HTA has the potential to support a wide range of applications in China's health care sector, building on the progress achieved over the last three decades.