Influence of pilot and small trials in meta-analyses of behavioral interventions: a meta-epidemiological study.

Influence of pilot and small trials in meta-analyses of behavioral interventions: a meta-epidemiological study.
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DOI:
10.1186/s13643-023-02184-7
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发表时间:
2023-02-18
期刊:
影响因子:
3.7
通讯作者:
--
中科院分区:
医学4区
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--
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试点/可行性或小样本研究可能与夸大效应有关。本研究探讨了荟萃分析中根据样本大小或试点/可行性状态考虑不同纳入标准时效应大小 (VoE) 的振动。检索的目的是确定 2016 年 1 月至 2019 年 10 月期间对儿童肥胖预防/治疗相关主题的行为干预措施进行荟萃分析的系统评价。从每个荟萃分析中提取计算得出的总结效应大小 (ES)。荟萃分析中包含的个别研究被分为以下四类之一:自我确定的试点/可行性研究或基于样本量但不是试点/可行性研究(N ≤ 100、N > 100和N > 370样本量的上75)。 VoE 被定义为仅限于研究分类的摘要 ES 的重新估计与最初报告的摘要 ES 之间的绝对差 (ABS)。评估了四类研究之间总结 ES 的统计显着性的一致性 (kappa)。估计了固定和随机效应模型以及元回归。提出了三个案例研究来说明包括试点/可行性研究和 N≤≤100 项研究对估计总结 ES 的影响。从包含 603 项独特研究的 48 项荟萃分析中提取了总共 1602 个效应量,代表 145 项报告的 ES 总结(每个荟萃分析平均 22 项研究,范围 2-108),包括 227,217 名参与者。试点/可行性研究和 N ≤ 100 项研究占荟萃分析中纳入研究的 22% (0–58%) 和 21% (0–83%)。元回归表明重新估计的 ES 与原始 ES 之间的 ABS,其中 ES 的范围从 0.20 到 0.46,具体取决于包含原始 ES 的研究比例,要么大部分较小(例如,N ≤ 100),要么大部分较大(N > 370)。当删除试点/可行性研究和 N ≤ 100 项研究 (kappa = 0.53) 并将分析仅限于最大的研究 (N > 370, kappa = 0.35) 时,一致性较低,最初报告的具有统计显着性的 ES 中有 20% 和 26% 变得不显着。对三个案例研究荟萃分析的重新分析导致重新估计的 ES 变得不显着或为最初报告的 ES 的一半。当行为干预的荟萃分析包括大量试点/可行性研究和 N≤≤100 项研究时,总结 ES 可能会受到显着影响,应谨慎解释。在线版本包含可在 10.1186/s13643-023-02184-7 获取的补充材料。
Pilot/feasibility or studies with small sample sizes may be associated with inflated effects. This study explores the vibration of effect sizes (VoE) in meta-analyses when considering different inclusion criteria based upon sample size or pilot/feasibility status. Searches were to identify systematic reviews that conducted meta-analyses of behavioral interventions on topics related to the prevention/treatment of childhood obesity from January 2016 to October 2019. The computed summary effect sizes (ES) were extracted from each meta-analysis. Individual studies included in the meta-analyses were classified into one of the following four categories: self-identified pilot/feasibility studies or based upon sample size but not a pilot/feasibility study (N ≤ 100, N > 100, and N > 370 the upper 75th of sample size). The VoE was defined as the absolute difference (ABS) between the re-estimations of summary ES restricted to study classifications compared to the originally reported summary ES. Concordance (kappa) of statistical significance of summary ES between the four categories of studies was assessed. Fixed and random effects models and meta-regressions were estimated. Three case studies are presented to illustrate the impact of including pilot/feasibility and N ≤ 100 studies on the estimated summary ES. A total of 1602 effect sizes, representing 145 reported summary ES, were extracted from 48 meta-analyses containing 603 unique studies (avg. 22 studies per meta-analysis, range 2–108) and included 227,217 participants. Pilot/feasibility and N ≤ 100 studies comprised 22% (0–58%) and 21% (0–83%) of studies included in the meta-analyses. Meta-regression indicated the ABS between the re-estimated and original summary ES where summary ES ranged from 0.20 to 0.46 depending on the proportion of studies comprising the original ES were either mostly small (e.g., N ≤ 100) or mostly large (N > 370). Concordance was low when removing both pilot/feasibility and N ≤ 100 studies (kappa = 0.53) and restricting analyses only to the largest studies (N > 370, kappa = 0.35), with 20% and 26% of the originally reported statistically significant ES rendered non-significant. Reanalysis of the three case study meta-analyses resulted in the re-estimated ES rendered either non-significant or half of the originally reported ES. When meta-analyses of behavioral interventions include a substantial proportion of both pilot/feasibility and N ≤ 100 studies, summary ES can be affected markedly and should be interpreted with caution. The online version contains supplementary material available at 10.1186/s13643-023-02184-7.
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发表时间: 2018-03
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