Department of Restorative Dentistry, School of Clinical Dentistry, University of Sheffield, Sheffield, UK.
Clin Oral Implants Res. 2011 Dec;22(12):1338-45. doi: 10.1111/j.1600-0501.2010.02124.x. Epub 2011 Mar 21.
The aim of this systematic review was to assess the methodological and statistical quality of randomised controlled trials of treatment interventions of dental implant surgery and prosthodontics published between 2004 and 2008.
Randomised controlled trials were identified following detailed searches of Medline, EMBASE, CINHAL and the Cochrane Central Register of Controlled Trials. Identified studies were independently assessed by two non-blinded reviewers for 14 key methodological and statistical domains. Information was collected using a customised data collection sheet.
The initial Medline search yielded 1484 studies. Following application of inclusion criteria 38 randomised controlled trials, not presenting the same patient material, were identified for this review. Inter-examiner agreement was assessed for all domains (median κ score 0.7). All disagreements were resolved by discussion. Randomisation was adequate in 16 trials (42%), allocation concealment was adequate in seven trials (18%) and outcome assessment was blind in 12 trials (31%). Seven trials (18%) tested the intra/inter-examiner reliability of at least one outcome of interest. Confidence intervals were reported in two trials (5%). Seventeen different statistical tests were used. However, inferential statistical analysis was considered appropriate in only 22 trials (57%).
Randomised controlled trials of treatment interventions of dental implant surgery and prosthodontics published between 2004 and 2008 are poorly reported and, by themselves, provide little unbiased evidence to support the clinical decisions that we make.
本系统评价的目的是评估 2004 年至 2008 年间发表的关于牙种植术和修复学治疗干预的随机对照试验的方法学和统计学质量。
通过详细搜索 Medline、EMBASE、CINHAL 和 Cochrane 对照试验中心注册库,确定了随机对照试验。两名非盲评阅人独立评估了 14 个关键的方法学和统计学领域。使用定制的数据收集表收集信息。
最初的 Medline 搜索产生了 1484 项研究。在应用纳入标准后,确定了 38 项随机对照试验,这些试验没有呈现相同的患者资料,供本综述使用。所有领域的观察者间一致性均进行了评估(中位数 κ 评分 0.7)。所有分歧均通过讨论解决。16 项试验(42%)的随机化是充分的,7 项试验(18%)的分配隐藏是充分的,12 项试验(31%)的结果评估是盲法的。7 项试验(18%)测试了至少一个感兴趣结局的内部/外部观察者可靠性。仅在两项试验(5%)中报告了置信区间。使用了 17 种不同的统计检验。然而,只有 22 项试验(57%)认为推断性统计分析是合适的。
2004 年至 2008 年间发表的关于牙种植术和修复学治疗干预的随机对照试验报告质量较差,仅凭自身提供的证据很少能够支持我们所做的临床决策。