Muratov Sergei, Podbielski Dominik W, Jack Susan M, Ahmed Iqbal Ike K, Mitchell Levine A H, Baltaziak Monika, Xie Feng
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.
BMJ Open. 2016 Nov 8;6(11):e012732. doi: 10.1136/bmjopen-2016-012732.
A primary objective of healthcare services is to improve patients' health and health-related quality of life (HRQoL). Glaucoma, which affects a substantial proportion of the world population, has a significant detrimental impact on HRQoL. Although there are a number of glaucoma-specific questionnaires to measure HRQoL, none is preference-based which prevent them from being used in health economic evaluation. The proposed study is aimed to develop a preference-based instrument that is capable of capturing important effects specific to glaucoma and treatments on HRQoL and is scored based on the patients' preferences.
A sequential, exploratory mixed methods design will be used to guide the development and evaluation of the HRQoL instrument. The study consists of several stages to be implemented sequentially: item identification, item selection, validation and valuation. The instrument items will be identified and selected through a literature review and the conduct of a qualitative study. Validation will be conducted to establish psychometric properties of the instrument followed by a valuation exercise to derive utility scores for the health states described.
This study has been approved by the Trillium Health Partners Research Ethics Board (ID number 753). All personal information will be de-identified with the identification code kept in a secured location including the rest of the study data. Only qualified and study-related personnel will be allowed to access the data. The results of the study will be distributed widely through peer-reviewed journals, conferences and internal meetings.
医疗服务的一个主要目标是改善患者的健康状况以及与健康相关的生活质量（HRQoL）。青光眼影响着世界上相当一部分人口，对HRQoL有重大的不利影响。虽然有一些用于测量HRQoL的青光眼专用问卷，但没有一个是基于偏好的，这使得它们无法用于卫生经济评估。本拟议研究旨在开发一种基于偏好的工具，该工具能够捕捉青光眼及其治疗对HRQoL的特定重要影响，并根据患者的偏好进行评分。
将采用一种序贯、探索性的混合方法设计来指导HRQoL工具的开发和评估。该研究包括几个需依次实施的阶段：条目识别、条目选择、验证和赋值。工具条目将通过文献综述和定性研究来识别和选择。将进行验证以确定该工具的心理测量特性，随后进行赋值练习以得出所描述健康状态的效用分数。
本研究已获得翠菊健康伙伴研究伦理委员会批准（编号753）。所有个人信息将进行去识别处理，识别码将保存在安全的位置，包括研究的其他数据。只有合格的与研究相关人员才被允许访问数据。研究结果将通过同行评审期刊、会议和内部会议广泛传播。
