D. G. LeBrun, Hospital for Special Surgery, New York, NY, USA D. G. LeBrun, T. Tran, D. Wypij , Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA T. Tran, Alpert Medical School of Brown University, Providence, RI, USA M. S. Kocher, Division of Sports Medicine, Boston Children's Hospital, Boston, MA, USA.
Clin Orthop Relat Res. 2019 Mar;477(3):655-662. doi: 10.1097/CORR.0000000000000612.
Case-control studies are a common method of analyzing associations between clinical outcomes and potential risk factors. Matching cases to controls based on known confounding variables can decrease bias and allow investigators to assess the association of interest with increased precision. However, the analysis of matched data generally requires matched statistical methods, and failure to use these methods can lead to imprecise or biased results. The appropriate use of matched statistical methods in orthopaedic case-control studies has not been documented.
QUESTIONS/PURPOSES: (1) What proportion of matched orthopaedic case-control studies use the appropriate matched statistical analyses? (2) What study factors are associated with the use of appropriate matched statistical tests?
All matched case-control studies published in the top 10 orthopaedic journals according to impact factor from 2007 to 2016 were identified by literature review. Studies using appropriate statistical techniques were identified by two independent evaluators; discrepancies were settled by a third evaluator, all with advanced training in biostatistics. The number of studies using appropriate matched statistical methods was compared with the number of studies reviewed. Logistic regression was used to identify key study factors (including journal, publication year, rank according to impact factor, number of matching factors, number of controls per case, and the inclusion of a biostatistician coauthor) associated with the use of appropriate statistical methods. Three hundred nineteen articles that were initially classified as case-control studies were screened, yielding 83 matched case-control studies. One hundred two of the excluded articles were cohort or cross-sectional studies that were misclassified as case-control studies. The median number of matching factors was 3.0 (range, 1-10) and the median number of controls per case was 1.0 (range, 0.5-6.0). Thirty studies (36%) had a statistician coauthor.
Thirty of the 83 included studies (36%) used appropriately matched methods throughout, 11 (13%) used matched methods for multivariable but not univariable analyses, and 42 (51%) used only unmatched methods, which we considered inappropriate. After controlling for the number of controls per case and publication year, we found that the inclusion of a statistician coauthor (70% versus 38%; odds ratio, 3.6; 95% confidence interval, 1.4-20.3; p = 0.01) and journal were associated with the use of appropriate methods.
Although matched case-control studies can be statistically more efficient study designs, in that they are capable of generating more precise effect size estimates than other kinds of retrospective research, most orthopaedic case-control studies use inappropriate statistical methods in their analyses. Additionally, the high degree of study misclassification indicates a need to more rigorously define differences among case-control, cohort, and cross-sectional study designs.
Failing to use matched statistical tests may lead to imprecise and/or biased effect estimates, which may lead to a tendency to overestimate or underestimate associations between possible risk factors and clinically relevant outcomes. Orthopaedic researchers should be cognizant of the risks and benefits of matching and should consult individuals with biostatistical expertise as needed to ensure that their statistical methods are appropriate and methodologically rigorous.
病例对照研究是分析临床结局与潜在风险因素之间关联的常用方法。根据已知的混杂变量对病例和对照进行匹配,可以减少偏倚,并使研究人员能够更精确地评估感兴趣的关联。然而,匹配数据的分析通常需要匹配的统计方法,如果不使用这些方法,可能会导致结果不精确或有偏倚。在骨科病例对照研究中,匹配统计方法的正确使用尚未得到记录。
问题/目的:(1)有多少比例的匹配骨科病例对照研究使用了适当的匹配统计分析?(2)哪些研究因素与适当的匹配统计检验的使用有关?
通过文献回顾,确定了 2007 年至 2016 年按影响因子排名前 10 的骨科期刊发表的所有匹配病例对照研究。由两位独立评估人员确定使用适当统计技术的研究;分歧由第三位评估人员解决,所有评估人员都接受过生物统计学的高级培训。将使用适当匹配统计方法的研究数量与审查的研究数量进行比较。采用逻辑回归确定与使用适当统计方法相关的关键研究因素(包括期刊、出版年份、按影响因子排名、匹配因素数量、每个病例的对照数量和包含生物统计学家合著者)。最初被归类为病例对照研究的 319 篇文章被筛选,得出 83 篇匹配病例对照研究。102 篇被排除的文章为队列或横断面研究,被错误归类为病例对照研究。匹配因素的中位数为 3.0(范围 1-10),每个病例的对照中位数为 1.0(范围 0.5-6.0)。30 项研究(36%)有统计学家合著者。
83 项纳入研究中有 30 项(36%)始终使用适当的匹配方法,11 项(13%)仅在多变量分析中使用匹配方法,而在单变量分析中未使用,42 项(51%)仅使用非匹配方法,我们认为这不恰当。在控制每个病例的对照数量和出版年份后,我们发现包含统计学家合著者(70%比 38%;比值比,3.6;95%置信区间,1.4-20.3;p=0.01)和期刊与使用适当方法有关。
尽管匹配病例对照研究在统计学上可以更有效地设计研究,因为它们能够生成比其他类型的回顾性研究更精确的效应大小估计值,但大多数骨科病例对照研究在分析中使用不适当的统计方法。此外,研究高度混淆表明需要更严格地定义病例对照、队列和横断面研究设计之间的差异。
不使用匹配的统计检验可能会导致不精确和/或有偏倚的效应估计,这可能导致高估或低估可能的风险因素与临床相关结局之间的关联。骨科研究人员应该意识到匹配的风险和益处,并根据需要咨询具有生物统计学专业知识的人员,以确保他们的统计方法是适当的和方法严谨的。