Zheng Yingfeng, Qu Bo, Jin Ling, Wang Chunxiao, Zhong Yuxin, He Mingguang, Liu Yizhi
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.
BMJ Open. 2020 May 18;10(5):e032242. doi: 10.1136/bmjopen-2019-032242.
The need for cataract surgery is on the rise due to our ageing population and high demands for greater visual functioning. Although the majority of patients want to participate in a shared decision-making process, no decision aid has been available to improve the quality of decision. The present study aims to determine whether a decision aid increases informed decision about cataract surgery.
A parallel randomised controlled trial (772 participants) will be conducted. The decision aid will be implemented among patients with any age-related cataract in Yuexiu District, which is socioeconomically representative of a major metropolitan region in Southern China. Participants will be randomly assigned to receive either a patient decision aid or a traditional booklet, and they will complete three surveys: (1) baseline assessment before the intervention (time point (T)1), 2 weeks (T2) and 1 year (T3) after the intervention. The control group receives a traditional booklet with standard general information developed by the National Eye Institute to help patients understand cataract, whereas the intervention group receives a patient decision aid that includes not only the standard general information, but also the quantitative risk information on the possible outcomes of cataract surgery as well as value clarification exercise. The primary study outcome is the informed decision, the percentage of patients who have adequate knowledge and demonstrate consistency between attitudes and intentions. Secondary outcomes include perceived importance of cataract surgery benefits/harms, decision conflict and confidence, anticipated regret and booklet utilisation and acceptability at 2 weeks, and surgical rates and a cost-utility estimate of the decision aid at 1 year.
Ethics approval was obtained from the Ethics Committee of Zhongshan Ophthalmic Center (reference number: 2019KYPJ090). Results will be published in peer-reviewed journals and presented at scientific meetings for academic audiences.
NCT03992807.
由于人口老龄化以及对更好视觉功能的高需求，白内障手术的需求正在上升。尽管大多数患者希望参与共同决策过程，但一直没有可用的决策辅助工具来提高决策质量。本研究旨在确定一种决策辅助工具是否能增加白内障手术的明智决策。
将进行一项平行随机对照试验（772名参与者）。该决策辅助工具将在越秀区患有任何年龄相关性白内障的患者中实施，越秀区在社会经济方面代表了中国南方一个主要大都市地区。参与者将被随机分配接受患者决策辅助工具或传统手册，并且他们将完成三项调查：（1）干预前的基线评估（时间点（T）1）、干预后2周（T2）和1年（T3）。对照组接受由美国国立眼科研究所编制的包含标准一般信息的传统手册，以帮助患者了解白内障，而干预组接受一种患者决策辅助工具，其不仅包括标准一般信息，还包括白内障手术可能结果的定量风险信息以及价值澄清练习。主要研究结果是明智决策，即拥有足够知识并在态度和意图上表现出一致性的患者百分比。次要结果包括对白内障手术益处/危害的感知重要性、决策冲突和信心、预期遗憾以及2周时手册的使用情况和可接受性，以及1年时的手术率和决策辅助工具的成本效用估计。
已获得中山眼科中心伦理委员会的伦理批准（参考编号：2019KYPJ090）。结果将发表在同行评审期刊上，并在面向学术受众的科学会议上展示。
NCT03992807。
