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牙科领域的随机对照试验:常见陷阱及规避方法。

Randomized controlled trials in dentistry: common pitfalls and how to avoid them.

作者信息

Fleming Padhraig S, Lynch Christopher D, Pandis Nikolaos

机构信息

Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AD, United Kingdom.

Learning & Scholarship, School of Dentistry, Cardiff University, United Kingdom.

出版信息

J Dent. 2014 Aug;42(8):908-14. doi: 10.1016/j.jdent.2014.06.004. Epub 2014 Jun 12.

DOI:10.1016/j.jdent.2014.06.004
PMID:24930873
Abstract

OBJECTIVE

Clinical trials are used to appraise the effectiveness of clinical interventions throughout medicine and dentistry. Randomized controlled trials (RCTs) are established as the optimal primary design and are published with increasing frequency within the biomedical sciences, including dentistry. This review outlines common pitfalls associated with the conduct of randomized controlled trials in dentistry.

METHODS

Common failings in RCT design leading to various types of bias including selection, performance, detection and attrition bias are discussed in this review. Moreover, methods of minimizing and eliminating bias are presented to ensure that maximal benefit is derived from RCTs within dentistry.

CONCLUSIONS

Well-designed RCTs have both upstream and downstream uses acting as a template for development and populating systematic reviews to permit more precise estimates of treatment efficacy and effectiveness. However, there is increasing awareness of waste in clinical research, whereby resource-intensive studies fail to provide a commensurate level of scientific evidence. Waste may stem either from inappropriate design or from inadequate reporting of RCTs; the importance of robust conduct of RCTs within dentistry is clear.

CLINICAL SIGNIFICANCE

Optimal reporting of randomized controlled trials within dentistry is necessary to ensure that trials are reliable and valid. Common shortcomings leading to important forms or bias are discussed and approaches to minimizing these issues are outlined.

摘要

目的

临床试验用于评估医学和牙科学中临床干预措施的有效性。随机对照试验(RCT)已被确立为最佳的主要设计方法,并且在包括牙科学在内的生物医学领域中发表的频率越来越高。本综述概述了牙科学中随机对照试验实施过程中常见的陷阱。

方法

本综述讨论了RCT设计中导致各种类型偏倚(包括选择偏倚、实施偏倚、检测偏倚和失访偏倚)的常见缺陷。此外,还介绍了减少和消除偏倚的方法,以确保从牙科学中的RCT中获得最大益处。

结论

设计良好的RCT具有上游和下游用途,可作为开展研究和进行系统评价的模板,从而更精确地估计治疗的疗效和效果。然而,人们越来越意识到临床研究中的浪费现象,即资源密集型研究未能提供相应水平的科学证据。浪费可能源于设计不当或RCT报告不充分;在牙科学中严谨开展RCT的重要性不言而喻。

临床意义

牙科学中随机对照试验的最佳报告对于确保试验的可靠性和有效性至关重要。讨论了导致重要偏倚形式的常见缺点,并概述了将这些问题最小化的方法。

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