Reporting of Randomized Controlled Trials With Statistically Nonsignificant Primary Outcomes Published in High-impact Surgical Journals
Reporting of Randomized Controlled Trials With Statistically Nonsignificant Primary Outcomes Published in High-impact Surgical Journals
复制标题
DOI：
10.1097/sla.0000000000001795
复制
发表时间：
2017-06-01
影响因子：
9
通讯作者：
Killeen, Shane
中科院分区：
文献类型：
--
作者：
Arunachalam, Lakshmanan;Hunter, Iain A.;Killeen, Shane
目的：确定失真呈现或“旋转”的性质和频率（即，特定的报告策略，强调实验性治疗是有益的，尽管主要结果的统计学上无显著差异，或分散读者对统计学上无显著差异结果的注意力）在外科杂志上发表的随机对照试验（RCT）报告中，主要结果的统计学上无显著差异。背景：多份报告表明，发表报告的作者可能会歪曲医学期刊中RCT结果的解释。方法：使用定义的检索策略，主要结局结果明显不显著的RCT 10种高影响因子的外科学期刊中，与对照组相比，差异无显著性（P > 0.05）（外科年鉴，神经病学，神经外科和精神病学杂志，心肺移植杂志，美国移植杂志，英国外科杂志，《骨与关节外科杂志》、《美国外科医师学会杂志》、《内窥镜检查》、《外科档案》和《肝移植》），发表于2013年7月至2015年7月。两名审查独立评估每个选定的文章使用一个有效的，标准化的数据abstractionform.Results：在所有，110个合格的随机对照试验与非显着的主要结果进行了评估。8篇（7%）文章报告了标题旋转。44篇（40%）纳入的摘要和39篇（35%）主要文本被分类为至少有1节有自旋。在16个（14%）摘要和19个（19%）正文“结论”部分中，旋转水平较高。25篇文章（23%）推荐了关注的干预措施，尽管主要结局不显著。试验资金来源，使用统计学家和文章部分，并存在spin.Conclusions：在随机对照试验与统计学上不显着的主要结果发表在外科杂志，结果的报告和解释往往是不一致的结果之间没有关系。
Objective: To determine the nature and frequency of distorted presentation or "spin'' (ie, specific reporting strategies which highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or distract the reader from statistically nonsignificant results) in published reports of randomized controlled trials (RCTs) with statistically nonsignificant results for primary outcomes in surgical journals.Background: Multiple reports have suggested that interpretation of RCT results in medical journals can be distorted by authors of published reports.Methods: Using a defined search strategy, RCTs with clearly nonsignificant results for the primary outcome (P > 0.05) form 10 high-impact factor surgical journals (Annals of Surgery, Journal of Neurology, Neurosurgery and Psychiatry, Journal of Heart and Lung Transplantation, American Journal of Transplantation, British Journal of Surgery, Journal of Bone and Joint Surgery, Journal of the American College of Surgeons, Endoscopy, Archives of Surgery, and Liver transplantation), published between July 2013 to July 2015, were identified. Two reviewers independently appraised each selected article using a validated, standardized data abstraction form.Results: In all, 110 eligible RCTs with nonsignificant primary outcomes were appraised. The title was reported with spin in 8 (7%) articles. Forty-four (40%) included abstracts and 39 (35%) main texts were classified as having spin in at least 1 section. The level of spin was high in 16 (14%) abstract and 19 (19%) main-text "Conclusions'' sections. Twenty-five articles (23%) recommended the intervention of interest despite a nonsignificant primary outcome. There was no relationship between trial funding source, use of statistician and article section, and the presence of spin.Conclusions: In RCTs with statistically nonsignificant primary outcomes published in surgical journals, the reporting and interpretation of findings was frequently inconsistent with the results.