Department of Oral Sciences, Section of Orthodontics and Temporomandibular disorders, University of Naples Federico II, Naples, Italy.
Int Dent J. 2011 Feb;61(1):37-42. doi: 10.1111/j.1875-595X.2011.00007.x.
Randomised controlled trials (RCTs) are regarded as the best study designs to test the efficacy of medical and dental intervention. Many reports, however, have shown that at the moment the quality of dental RCT reports is still poor, and further efforts to improve it are necessary. It has been suggested that trials that are not well designed provide biased estimates of the treatment effects and that a journal's impact factor is not related to the quality of RCTs published. For these reasons, before trusting RCT reports, a careful assessment of the study selected is needed. Randomisation, blinding, allocation concealment, drop outs analysis are essential quality components of RCTs. Many systems for RCTs quality assessment are available. In this report the concept of quality of RCTs will be critically evaluated and the most commonly used instruments available for quality assessment of RCTs in dental research will be reviewed.
随机对照试验（RCT）被认为是测试医学和牙科干预措施疗效的最佳研究设计。然而，许多报告表明，目前牙科 RCT 报告的质量仍然很差，需要进一步努力加以改进。有人认为，设计不佳的试验会对治疗效果产生有偏差的估计，而且期刊的影响因子与发表的 RCT 质量无关。出于这些原因，在信任 RCT 报告之前，需要对所选研究进行仔细评估。随机化、盲法、分配隐藏、脱落分析是 RCT 的重要质量组成部分。有许多 RCT 质量评估系统。本报告将对 RCT 的质量进行批判性评估，并回顾牙科研究中常用的 RCT 质量评估工具。
