Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Laarbeeklaan 101, Brussels 1090, Belgium.
Hum Reprod. 2011 Jun;26(6):1371-6. doi: 10.1093/humrep/der044. Epub 2011 Feb 28.
Treatment decisions should ideally be based on well-designed randomized controlled trials (RCTs). Here we determine the rate of full publication of RCTs presented at annual meetings of the European Society of Human Reproduction and Embryology (ESHRE), identify potential bias against publishing non-significant results and results not favoring the experimental arm, quantify this bias in case it exists, and identify factors associated with time to publication.
RCTs presented at ESHRE meetings 2003 and 2004 were recorded. Subsequent search in Medline, Cochrane Library and EMBASE was performed through December 2010 to identify full-text publication in a peer-review journal.
Among 155 abstracts describing RCTs 89 (57%) were published in full-text in a peer-review journal. Median time from presentation to publication was 15 months (range: 0-75). In bivariate analysis, only type of presentation and presence of outcomes favoring the experimental arm were related to publication rate. Studies presented orally or reporting a positive outcome in favor of the experimental arm were more likely to be published (P = 0.018 and 0.014, respectively). Results were consistent in a multivariable logistic regression, with odds ratio (OR) 2.51 [95% confidence interval (CI), 1.25-5.03] for oral versus poster presentations and OR 2.46 (95% CI, 1.23-4.95) for trials favoring versus not favoring the experimental arm. Kaplan-Meier curves revealed time to publication was shorter for oral presentations (log-rank test = 0.013) and trials favoring the experimental arm, compared with all others (log rank = 0.007).
RCTs with significant results in favor of the experimental arm are more likely to be published and are published sooner. Publication bias in reproductive medicine is a fact.
治疗决策理想上应基于精心设计的随机对照试验(RCT)。在这里,我们确定了在欧洲人类生殖与胚胎学会(ESHRE)年会上报告的 RCT 完全发表的比率,确定了对发表非显著性结果和不利于试验组结果的潜在偏见,量化了如果存在这种偏见的程度,并确定了与发表时间相关的因素。
记录了在 ESHRE 会议 2003 年和 2004 年报告的 RCT。随后在 2010 年 12 月之前通过 Medline、Cochrane 图书馆和 EMBASE 进行了后续检索,以确定在同行评议期刊上发表的全文。
在 155 份描述 RCT 的摘要中,有 89 份(57%)以全文形式在同行评议期刊上发表。从报告到发表的中位数时间为 15 个月(范围:0-75)。在单变量分析中,只有报告类型和有利于试验组的结果存在与发表率相关。口头报告或报告有利于试验组的阳性结果的研究更有可能发表(P=0.018 和 0.014)。在多变量逻辑回归中结果一致,口头报告与海报报告相比,OR 为 2.51(95%CI,1.25-5.03),有利于试验组的试验与不利于试验组的试验相比,OR 为 2.46(95%CI,1.23-4.95)。Kaplan-Meier 曲线显示,口头报告(对数秩检验=0.013)和有利于试验组的试验的发表时间较短,与其他所有试验相比(对数秩检验=0.007)。
有利于试验组的具有显著性结果的 RCT 更有可能发表,并且发表时间更早。生殖医学中的发表偏倚是一个事实。