LOST to follow-up Information in Trials (LOST-IT): a protocol on the potential impact.
LOST to follow-up Information in Trials (LOST-IT): a protocol on the potential impact.
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DOI：
10.1186/1745-6215-10-40
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发表时间：
2009-06-11
期刊：
影响因子：
2.5
通讯作者：
Guyatt GH
中科院分区：
文献类型：
--
作者：
Akl EA;Briel M;You JJ;Lamontagne F;Gangji A;Cukierman-Yaffe T;Alshurafa M;Sun X;Nerenberg KA;Johnston BC;Vera C;Mills EJ;Bassler D;Salazar A;Bhatnagar N;Busse JW;Khalid Z;Walter S;Cook DJ;Schünemann HJ;Altman DG;Guyatt GH
如果患者数据不可用的原因与关注的结局相关，则随机对照试验（RCT）中结局的不完全确定可能会使最终研究结果产生偏倚。本研究的主要目的是评估失访对治疗效果估计值的潜在影响。次要目的是描述已发表RCT的（1）失访信息的报告，（2）用于处理失访信息的分析方法，以及（3）报告失访的程度。我们将对最近发表在五种顶级综合医学期刊上的RCT报告进行系统综述。合格的RCT将证明对患者重要的主要结局的统计学显著性效应估计，并表示为二进制数据。由2名审查员组成的小组将独立确定合格性，并使用标准化的预试验表格从每项合格试验中提取相关信息。为了评估失访对治疗效果估计值的潜在影响，我们将针对关于失访受试者结局（LTFU）的不同假设，计算（1）失去统计学显著性的RCT百分比和（2）RCT间效果估计值的平均变化。我们将测试的不同假设如下：（1）LTFU参与者均未发生该事件;（2）所有LTFU参与者均发生该事件;（3）治疗组中的所有LTFU参与者均发生该事件;对照组中无一人发生该事件（最坏情况）;（4）LTFU参与者中的事件发生率（相对于观察的参与者）增加，干预组的相对增加更高;（5）LTFU参与者的事件发生率（相对于观察参与者）在干预组中增加，而在对照组中减少。我们的目标和方法是透明的。这项研究的结果可能对临床试验者和医学文献的用户都有重要意义。
Incomplete ascertainment of outcomes in randomized controlled trials (RCTs) is likely to bias final study results if reasons for unavailability of patient data are associated with the outcome of interest. The primary objective of this study is to assess the potential impact of loss to follow-up on the estimates of treatment effect. The secondary objectives are to describe, for published RCTs, (1) the reporting of loss to follow-up information, (2) the analytic methods used for handling loss to follow-up information, and (3) the extent of reported loss to follow-up. We will conduct a systematic review of reports of RCTs recently published in five top general medical journals. Eligible RCTs will demonstrate statistically significant effect estimates with respect to primary outcomes that are patient-important and expressed as binary data. Teams of 2 reviewers will independently determine eligibility and extract relevant information from each eligible trial using standardized, pre-piloted forms. To assess the potential impact of loss to follow-up on the estimates of treatment effect we will, for varying assumptions about the outcomes of participants lost to follow-up (LTFU), calculate (1) the percentage of RCTs that lose statistical significance and (2) the mean change in effect estimate across RCTs. The different assumptions we will test are the following: (1) none of the LTFU participants had the event; (2) all LTFU participants had the event; (3) all LTFU participants in the treatment group had the event; none of those in the control group had it (worst case scenario); (4) the event incidence among LTFU participants (relative to observed participants) increased, with a higher relative increase in the intervention group; and (5) the event incidence among LTFU participants (relative to observed participants) increased in the intervention group and decreased in the control group. We aim to make our objectives and methods transparent. The results of this study may have important implications for both clinical trialists and users of the medical literature.
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通讯作者：
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