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Title: | Development and Validation of a Preference-based Health Related Quality Of Life Instrument for Patients with Cardiovascular Diseases In China |
Authors: | Li, Xue |
Advisor: | Xie, Feng Van Spall, Harriette Klassen, Anne |
Department: | Health Research Methodology |
Publication Date: | 2023 |
Abstract: | Health-related quality of life (HRQoL), often reported by patients themselves, have been widely collected in clinical trials and clinical practices. Preference-based HRQoL instruments can be used to generate health utilities for the calculation of quality-adjusted life years (QALYs), a recommended metric for health economic evaluation and coverage decision-making. Cardiovascular diseases (CVDs) are the cause of death globally, accounting for 32% of all deaths worldwide. Existing CVD-specific HRQoL instruments are developed by western countries. This may impose challenges when measuring HRQoL in China where there is a different social-cultural context. For example, items such as cleaning the yard or sexual activities included in some CVD-specific instruments may not be feasible for China. In addition, all the existing CVD-specific HRQoL instruments are profile-based, which cannot be used to generate utilities. In 2018, China has established the National Healthcare Security Administration (NHSA), a governmental agency responsible for making coverage decisions through a centralized review and pricing negotiation process. A QALY is a recommended outcome measure in this process. There is a need for a preference-based instrument to support national coverage decision-making in China. The objective of this thesis is to develop and validate a CVD-specific, preference-based, HRQoL instrument for use in China. This project began with two systematic reviews and quality assessments of all existing CVD-specific HRQoL instruments by using a standard assessment tool, highlighting key methodological challenges for developing and validating instruments, summarizing the core conceptual framework of HRQoL for CVD and selecting reference instruments for validation. This part of the study was followed by qualitative one-on-one interviews with 135 Chinese patients with CVD, multiple rounds of expert panel consultations and two rounds of cognitive debriefing interviews with 20 patients and 13 physicians. The qualitative data were used to develop an initial version of an instrument, i.e., the China Health Related Outcomes Measures-cardiovascular diseases (CHROME-CVD). Finally, this project concluded with a two-stage validation of the CHROME-CVD with 1,365 patients with CVD in China. The final version of CHROME-CVD was developed and validated and is available for clinical use. |
URI: | http://hdl.handle.net/11375/29096 |
Appears in Collections: | Open Access Dissertations and Theses |
Files in This Item:
File | Description | Size | Format | |
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Li_Xue_202309_PhD.pdf | 8.97 MB | Adobe PDF | View/Open |
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