Fleming Padhraig S, Koletsi Despina, Dwan Kerry, Pandis Nikolaos
Oral Growth and Development, Barts and The London School of Medicine and Dentistry, Institute of Dentistry, Queen Mary University of London, London, England.
Department of Orthodontics, University of Athens, Athens, Greece.
PLoS One. 2015 May 21;10(5):e0127495. doi: 10.1371/journal.pone.0127495. eCollection 2015.
Selective outcome reporting of either interesting or positive research findings is problematic, running the risk of poorly-informed treatment decisions. We aimed to assess the extent of outcome and other discrepancies and possible selective reporting between registry entries and published reports among leading medical journals.
Randomized controlled trials published over a 6-month period from July to December 31st, 2013, were identified in five high impact medical journals: The Lancet, British Medical Journal, New England Journal of Medicine, Annals of Internal Medicine and Journal of American Medical Association were obtained. Discrepancies between published studies and registry entries were identified and related to factors including registration timing, source of funding and presence of statistically significant results.
Over the 6-month period, 137 RCTs were found. Of these, 18% (n = 25) had discrepancies related to primary outcomes with the primary outcome changed in 15% (n = 20). Moreover, differences relating to non-primary outcomes were found in 64% (n = 87) with both omission of pre-specified non-primary outcomes (39%) and introduction of new non-primary outcomes (44%) common. No relationship between primary or non-primary outcome change and registration timing (prospective or retrospective; P = 0.11), source of funding (P = 0.92) and presence of statistically significant results (P = 0.92) was found.
Discrepancies between registry entries and published articles for primary and non-primary outcomes were common among trials published in leading medical journals. Novel approaches are required to address this problem.
选择性报告有趣或阳性的研究结果存在问题，可能导致治疗决策缺乏充分信息。我们旨在评估主要医学期刊中注册登记条目与已发表报告之间结果及其他差异的程度，以及可能存在的选择性报告情况。
在五种高影响力医学期刊中识别出2013年7月至12月31日这6个月期间发表的随机对照试验：获取了《柳叶刀》《英国医学杂志》《新英格兰医学杂志》《内科学年鉴》和《美国医学会杂志》。确定已发表研究与注册登记条目之间的差异，并分析其与注册时间、资金来源和具有统计学显著结果等因素的关系。
在这6个月期间，共发现137项随机对照试验。其中，18%（n = 25）的试验在主要结局方面存在差异，15%（n = 20）的试验主要结局发生了改变。此外，64%（n = 87）的试验在非主要结局方面存在差异，预先指定的非主要结局被遗漏（39%）和引入新的非主要结局（44%）的情况都很常见。未发现主要或非主要结局变化与注册时间（前瞻性或回顾性；P = 0.11）、资金来源（P = 0.92）以及具有统计学显著结果（P = 0.92）之间存在关联。
在主要医学期刊发表的试验中，注册登记条目与已发表文章在主要和非主要结局方面的差异很常见。需要采用新的方法来解决这一问题。
