Gewandter Jennifer S, McDermott Michael P, McKeown Andrew, Smith Shannon M, Williams Mark R, Hunsinger Matthew, Farrar John, Turk Dennis C, Dworkin Robert H
Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Departments of Biostatistics and Computational Biology and Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA School of Professional Psychology, Pacific University, Hillsboro, OR, USA Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, USA Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.
Pain. 2014 Sep;155(9):1871-1877. doi: 10.1016/j.pain.2014.06.018. Epub 2014 Jun 30.
Missing data in clinical trials can bias estimates of treatment effects. Statisticians and government agencies recommend making every effort to minimize missing data. Although statistical methods are available to accommodate missing data, their validity depends on often untestable assumptions about why the data are missing. The objective of this study was to assess the frequency with which randomized clinical trials published in 3 major pain journals (ie, European Journal of Pain, Journal of Pain, and Pain) reported strategies to prevent missing data, the number of participants who completed the study (ie, completers), and statistical methods to accommodate missing data. A total of 161 randomized clinical trials investigating treatments for pain, published between 2006 and 2012, were included. Approximately two-thirds of the trials reported at least 1 method that could potentially minimize missing data, the most common being allowance of concomitant medications. Only 61% of the articles explicitly reported the number of patients who were randomized and completed the trial. Although only 14 articles reported that all randomized participants completed the study, fewer than 50% of the articles reported a statistical method to accommodate missing data. Last observation carried forward imputation was used most commonly (42%). Thirteen articles reported more than 1 method to accommodate missing data; however, the majority of methods, including last observation carried forward, were not methods currently recommended by statisticians. Authors, reviewers, and editors should prioritize proper reporting of missing data and appropriate use of methods to accommodate them so as to improve the deficiencies identified in this systematic review.
临床试验中的数据缺失可能会使治疗效果的估计产生偏差。统计学家和政府机构建议尽一切努力将数据缺失降至最低。尽管有统计方法可用于处理缺失数据，但其有效性取决于关于数据缺失原因的往往无法检验的假设。本研究的目的是评估在3种主要疼痛期刊（即《欧洲疼痛杂志》、《疼痛杂志》和《疼痛》）上发表的随机临床试验报告预防数据缺失策略的频率、完成研究的参与者数量（即完成者）以及处理缺失数据的统计方法。共纳入了2006年至2012年间发表的161项研究疼痛治疗的随机临床试验。约三分之二的试验报告了至少1种可能将数据缺失降至最低的方法，最常见的是允许使用伴随药物。只有61%的文章明确报告了随机分组并完成试验的患者数量。虽然只有14篇文章报告所有随机参与者都完成了研究，但不到50%的文章报告了处理缺失数据的统计方法。末次观察结转插补法使用最为普遍（42%）。13篇文章报告了不止1种处理缺失数据的方法；然而，包括末次观察结转法在内的大多数方法并非统计学家目前推荐的方法。作者、审稿人和编辑应优先正确报告数据缺失情况并适当使用处理数据缺失的方法，以改善本系统评价中发现的不足之处。
