Worsley Sally D, Oude Rengerink Katrien, Irving Elaine, Lejeune Stephane, Mol Koen, Collier Sue, Groenwold Rolf H H, Enters-Weijnen Catherine, Egger Matthias, Rhodes Thomas
Real World Evidence, GSK R&D, Gunnels Wood Road, Stevenage, Hertfordshire SG12NY, UK.
Julius Center for Health Sciences and Primary Care, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.
J Clin Epidemiol. 2017 Aug;88:14-20. doi: 10.1016/j.jclinepi.2017.05.003. Epub 2017 May 11.
This second article in the series on pragmatic trials describes the challenges in selection of sites for pragmatic clinical trials and the impact on validity, precision, and generalizability of the results. The selection of sites is an important factor for the successful execution of a pragmatic trial and impacts the extent to which the results are applicable to future patients in clinical practice. The first step is to define usual care and understand the heterogeneity of sites, patient demographics, disease prevalence and country choice. Next, specific site characteristics are important to consider such as interest in the objectives of the trial, the level of research experience, availability of resources, and the expected number of eligible patients. It can be advisable to support the sites with implementing the trial-related activities and minimize the additional burden that the research imposes on routine clinical practice. Health care providers should be involved in an early phase of protocol development to generate engagement and ensure an appropriate selection of sites with patients who are representative of the future drug users.
本系列关于实用试验的第二篇文章描述了实用临床试验中选择试验地点所面临的挑战，以及对结果的有效性、精确性和可推广性的影响。试验地点的选择是实用试验成功实施的一个重要因素，并且会影响结果在临床实践中适用于未来患者的程度。第一步是界定常规治疗并了解试验地点的异质性、患者人口统计学特征、疾病患病率以及国家选择。接下来，考虑特定的试验地点特征很重要，例如对试验目标的兴趣、研究经验水平、资源可用性以及符合条件的患者预期数量。支持试验地点开展与试验相关的活动，并尽量减少研究给常规临床实践带来的额外负担，这可能是明智之举。医疗保健提供者应在方案制定的早期阶段参与进来，以提高参与度，并确保恰当地选择有代表性的试验地点，这些地点的患者应能代表未来的药物使用者。
