University of North Carolina at Chapel Hill, School of Dentistry, NC 27599-7450, USA.
J Public Health Dent. 2010 Summer;70(3):171-5. doi: 10.1111/j.1752-7325.2010.00167.x.
As the number of dental-related randomized clinical trials (RCTs) increases, there is a need for literature to help investigators inexperienced in conducting RCTs design and implement studies. This commentary describes four "lessons learned" or considerations important in the planning and initial implementation of RCTs in dentistry that, to our knowledge, have not been discussed in the general dental literature describing trial techniques. These considerations are a) preparing or securing a thorough systematic review; b) developing a comprehensive set of study documents; c) designing and testing multiple recruitment strategies; and d) employing a run-in period prior to enrollment. Attention to these considerations in the planning phases of a dental RCT can help ensure that the trial is clinically relevant while also maximizing the likelihood that its implementation will be successful.
随着牙科相关随机临床试验 (RCT) 的数量增加，需要有文献来帮助那些没有 RCT 设计和实施经验的研究人员。本篇述评描述了四项“经验教训”或在牙科 RCT 规划和初步实施中重要的考虑因素，据我们所知，这些因素尚未在描述试验技术的一般牙科文献中讨论过。这些考虑因素包括：a）准备或确保全面的系统评价；b）制定一套全面的研究文件；c）设计和测试多种招募策略；以及 d）在入组前采用预试验阶段。在牙科 RCT 的规划阶段注意这些因素，可以帮助确保试验具有临床相关性，同时最大限度地提高其实施成功的可能性。
