Perestelo-Pérez Lilisbeth, Rivero-Santana Amado, Boronat Mauro, Sánchez-Afonso Juan A, Pérez-Ramos Jeanette, Montori Victor M, Serrano-Aguilar Pedro
Evaluation Unit of the Canary Islands Health Service (SESCS), Tenerife, Spain; Health Services Research on Chronic Patients Network (REDISSEC), Spain; Center for Biomedical Research of the Canary Islands (CIBICAN), Tenerife, Spain.
Health Services Research on Chronic Patients Network (REDISSEC), Spain; Center for Biomedical Research of the Canary Islands (CIBICAN), Tenerife, Spain; Canarian Islands Foundation of Health Research (FUNCANIS), Tenerife, Spain.
Patient Educ Couns. 2016 Feb;99(2):295-9. doi: 10.1016/j.pec.2015.08.032. Epub 2015 Sep 1.
Statin choice, an encounter decision aid (DA), was developed in the USA to facilitate shared decision making between patients and clinicians about the use of statins to reduce cardiovascular risk. We aimed to assess the efficacy of this DA, compared to usual primary care, in Spanish patients with type 2 diabetes.
Cluster randomized trial with 29 clinicians and 168 patients. Knowledge of statins, cardiovascular risk perception, decisional conflict, anxiety and satisfaction with the decision making process were assessed immediately after intervention, and self-reported adherence at three months.
Intervention significantly improved knowledge (p=0.01), perception of the 10-year risk of myocardial infarction without (p=0.01) and with statins (p=0.08), and satisfaction (p=0.01). There were no significant differences in decisional conflict, anxiety, consultation time or adherence, although more intervention patients reported taking all pills during the last week (92.7% vs. 81%; p=0.19).
The statin choice DA improved the quality of decision making about statins.
This trial contributes to the body of evidence substantiating the efficacy of statin choice and extending it to Spanish clinicians and their patients with type 2 diabetes.
This trial is registered with the European Union Clinical Trials Register (EudraCT: 2010-023912-14).
“他汀类药物选择”这一诊疗决策辅助工具(DA)在美国研发,旨在促进患者与临床医生之间就使用他汀类药物降低心血管风险进行共同决策。我们旨在评估该决策辅助工具与常规初级保健相比,对西班牙2型糖尿病患者的疗效。
对29名临床医生和168名患者进行整群随机试验。在干预后立即评估对他汀类药物的了解、心血管风险认知、决策冲突、焦虑程度以及对决策过程的满意度,并在三个月时评估自我报告的依从性。
干预显著提高了知识水平(p = 0.01)、对未使用他汀类药物时心肌梗死10年风险的认知(p = 0.01)以及使用他汀类药物时的认知(p = 0.08),并提高了满意度(p = 0.01)。在决策冲突、焦虑程度、咨询时间或依从性方面没有显著差异,尽管更多接受干预的患者报告在过去一周内服用了所有药物(92.7%对81%;p = 0.19)。
“他汀类药物选择”决策辅助工具提高了关于他汀类药物的决策质量。
该试验为证实“他汀类药物选择”的疗效并将其推广至西班牙临床医生及其2型糖尿病患者的证据体系做出了贡献。
本试验已在欧盟临床试验注册中心注册(EudraCT:2010 - 023912 - 14)。