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口腔种植体随机对照试验的质量评估

Quality assessment of randomized controlled trials of oral implants.

作者信息

Esposito M, Coulthard P, Worthington H V, Jokstad A

机构信息

Institute of Anatomy and Cell Biology, Göteborg University, Sweden.

出版信息

Int J Oral Maxillofac Implants. 2001 Nov-Dec;16(6):783-92.

Abstract

The aim of this study was to assess the quality of randomized controlled trials (RCTs) concerned with the effectiveness of oral implants and to create a trial register. A multilayered search strategy was used to identify all RCTs published by the end of 1999 in any language. The Cochrane Oral Health Group specialist register, PubMed, and personal libraries were searched. Seventy-four RCTs were identified. Forty-three articles, not presenting the same patient material, were independently assessed by 3 researchers using a specially designed form. A statistician assessed all trials for the appropriateness of statistics. The quality of each study was assessed on 7 items, including 3 key domains. Randomization and concealment allocation procedures were not described in 30 articles (70%). Reasons for withdrawals were not given in 10 reports (23%). No attempt at blinding was reported in 31 studies (72%). The quality of RCTs of oral implants is generally poor and needs to be improved.

摘要

本研究的目的是评估有关口腔种植体有效性的随机对照试验(RCT)的质量,并建立一个试验登记册。采用多层次搜索策略来识别1999年底前以任何语言发表的所有RCT。检索了Cochrane口腔健康小组专业登记册、PubMed和个人藏书。共识别出74项RCT。3名研究人员使用专门设计的表格对43篇未呈现相同患者材料的文章进行了独立评估。一名统计学家评估了所有试验统计方法的适用性。根据7个项目(包括3个关键领域)对每项研究的质量进行了评估。30篇文章(70%)未描述随机化和隐藏分配程序。10份报告(23%)未给出退出原因。31项研究(72%)未报告采用盲法。口腔种植体RCT的质量普遍较差,需要改进。

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