University of Toronto, Toronto, Ontario, Canada ; Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada ; Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
University of Toronto, Toronto, Ontario, Canada ; Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.
PLoS Med. 2014 Feb 4;11(2):e1001588. doi: 10.1371/journal.pmed.1001588. eCollection 2014 Feb.
Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes.
All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population.
The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions.
http://www.ClinicalTrials.gov NCT01411865 and NCT01026688.
印刷教育材料是临床医生教育中最常用的方法之一，用于提高医疗质量。本实用型群组随机试验的目的是评估针对糖尿病患者心血管疾病筛查和风险降低的教育工具包的有效性。
利用人群水平的行政数据库对加拿大安大略省所有年龄≥40 岁且确诊患有糖尿病的 933789 人进行了研究，从高危患者中随机抽取 1592 例患者，收集了额外的临床结局数据。家庭医生诊所于 2009 年 6 月（干预组）或 2010 年 5 月（对照组）随机分配接受教育工具包。在行政数据研究中，主要结局为死亡或非致死性心肌梗死，干预组有 11736（2.5%）例患者发生，对照组有 11536（2.5%）例患者发生（p=0.77）。临床数据研究中的主要结局为他汀类药物的使用，干预组有 700（88.1%）例患者使用，对照组有 725（90.1%）例患者使用（p=0.26）。预先指定的次要结局，包括其他临床事件、护理流程和危险因素控制措施，也没有因干预而改善。一个限制是该人群中他汀类药物的起始治疗率较高。
教育工具包并未改善糖尿病患者的医疗质量或心血管结局。尽管实施相对简单且经济，但印刷教育材料并不有效。该研究强调了需要采用严格和基于科学的方法来开发、传播和评估质量改进干预措施。
http://www.ClinicalTrials.gov NCT01411865 和 NCT01026688。
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