Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results: A Systematic Review.
Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results: A Systematic Review.
复制标题
DOI：
10.1001/jamanetworkopen.2021.35765
复制
发表时间：
2021-12-01
影响因子：
13.8
通讯作者：
Oba K
中科院分区：
文献类型：
--
作者：
Ito C;Hashimoto A;Uemura K;Oba K
主要终点结果不具有统计显着性的非劣效性试验的解释和报告是否正确？误导性报告的相关因素有哪些？这项对 52 项癌症治疗非劣效性随机临床试验的系统评价，其主要终点结果不具有统计学意义，其中 75% 包含误导性报告。多变量分析发现，在营利性来源资助的报告中，误导性报告的发生率明显较低，而在新型实验治疗的报告中，误导性报告的发生率则较高。这些发现表明作者应仔细考虑非劣效性癌症临床试验结果的解释和报告，特别是对于统计上不显着的主要结局结果。本系统评价检查了非劣效性随机临床试验中的误导性报告和相关因素，其主要结果不具有统计学意义。自旋是随机临床试验 (RCT) 的不准确报告，其结果对于主要终点没有统计学意义，扭曲了结果的解释并导致误解。然而，非劣效性癌症随机对照试验中旋转和相关因素的流行率仍不清楚。通过系统评价来检查非劣效性癌症随机对照试验中的误导性报告或虚假陈述以及相关因素。使用 Cochrane 高灵敏度检索策略对 PubMed 数据库中 2010 年 1 月 1 日至 2019 年 12 月 31 日期间发表的文章进行了系统检索。两名研究人员使用非劣效性平行组随机对照试验纳入标准独立选择了研究，旨在确认2010年1月1日至2019年12月31日期间发表的癌症治疗效果，报告的结果对于主要终点没有统计学意义。标准化数据抽象用于根据预先指定的定义提取有关试验特征和旋转的信息。主要研究者提取试验特征，而两位读者独立评估旋转。遵循系统评价和荟萃分析的首选报告项目 (PRISMA) 报告指南。主要结果是报告中任何部分的旋转流行率。旋转被定义为无论出于何种动机，使用特定的报告策略来强调实验治疗是有益的，尽管主要结果没有统计学上的显着差异，或者分散读者对不具有统计学意义的结果的注意力。还评估了旋转和试验特征之间的关联（患病率差异和比值比 [OR]）。该分析包括 PubMed 搜索中确定的 2752 份报告中的 52 份。 39 份报告（75.0%；95% CI，61.6%-84.9%）中发现了旋转，包括摘要（34 份报告[65.4%；95% CI，51.1%-76.9%]）和正文（38 份报告[73.1%；95% CI，59.7%-83.3%]）。单变量分析发现，有数据管理者的报告（患病率差异，27%；95% CI，1.1%-50.3%）、没有营利性来源资助的报告（患病率差异，31.2%；95% CI，4.8%-53.8%）和新实验治疗的报告（患病率差异，37.5%；95% CI， 5.8%-64.7%）。多变量分析发现，新颖的实验治疗（OR，4.64；95% CI，0.98-22.02）和仅来自非营利来源的资金（OR，5.20；95% CI，1.21-22.29）与旋转相关。在本次系统评价中，大多数非劣效性随机对照试验报告的主要终点结果在统计上不显着，显示出扭曲的解释和不准确的报告。实验性治疗的新颖性和仅来自非营利来源的资金与旋转有关。
Is the interpretation and reporting of noninferiority trials with primary end point results that are not statistically significant correct, and what are the associated factors of misleading reporting? This systematic review of 52 noninferiority randomized clinical trials of cancer treatments with results for primary end points that are not statistically significant, 75% included misleading reporting. Multivariable analysis found that the prevalence of misleading reporting was significantly lower in reports with funding from for-profit sources and higher in reports of novel experimental treatments. These findings suggest that authors should carefully consider noninferiority cancer clinical trial result interpretation and reporting, especially for primary outcome results that are not statistically significant. This systematic review examines misleading reporting and associated factors in noninferiority randomized clinical trials with primary results that are not statistically significant. Spin, the inaccurate reporting of randomized clinical trials (RCTs) with results that are not statistically significant for the primary end point, distorts interpretation of results and leads to misinterpretation. However, the prevalence of spin and related factors in noninferiority cancer RCTs remains unclear. To examine misleading reporting, or spin, and the associated factors in noninferiority cancer RCTs through a systematic review. A systematic search of the PubMed database was performed for articles published between January 1, 2010, and December 31, 2019, using the Cochrane Highly Sensitive Search Strategy. Two investigators independently selected studies using the inclusion criteria of noninferiority parallel-group RCTs aiming to confirm effects to cancer treatments published between January 1, 2010, and December 31, 2019, reporting results that were not statistically significant for the primary end points. Standardized data abstraction was used to extract information concerning the trial characteristics and spin based on a prespecified definition. The main investigator extracted the trial characteristics while both readers independently evaluated the spin. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline was followed. The main outcome was spin prevalence in any section of the report. Spin was defined as use of specific reporting strategies, from whatever motive, to highlight that the experimental treatment is beneficial, despite no statistically significant difference for the primary outcome, or to distract the reader from results that are not statistically significant. The associations (prevalence difference and odds ratios [ORs]) between spin and trial characteristics were also evaluated. The analysis included 52 of 2752 reports identified in the PubMed search. Spin was identified in 39 reports (75.0%; 95% CI, 61.6%-84.9%), including the abstract (34 reports [65.4%; 95% CI, 51.1%-76.9%]) and the main text (38 reports [73.1%; 95% CI, 59.7%-83.3%]). Univariate analysis found that the spin prevalence was higher in reports with data managers (prevalence difference, 27%; 95% CI, 1.1%-50.3%), reports without funding from for-profit sources (prevalence difference, 31.2%; 95% CI, 4.8%-53.8%), and reports of novel experimental treatments (prevalence difference, 37.5%; 95% CI, 5.8%-64.7%). Multivariable analysis found that novel experimental treatment (OR, 4.64; 95% CI, 0.98-22.02) and funding only from nonprofit sources only (OR, 5.20; 95% CI, 1.21-22.29) were associated with spin. In this systematic review, most noninferiority RCTs reporting results that were not statistically significant for the primary end points showed distorted interpretation and inaccurate reporting. The novelty of an experimental treatment and funding only from nonprofit sources were associated with spin.
登录
查看更多内容
DOI：
10.1016/s1470-2045(14)70460-7
发表时间：
2014-11
期刊：
The Lancet. Oncology
影响因子：
--
作者：
Donker M;van Tienhoven G;Straver ME;Meijnen P;van de Velde CJ;Mansel RE;Cataliotti L;Westenberg AH;Klinkenbijl JH;Orzalesi L;Bouma WH;van der Mijle HC;Nieuwenhuijzen GA;Veltkamp SC;Slaets L;Duez NJ;de Graaf PW;van Dalen T;Marinelli A;Rijna H;Snoj M;Bundred NJ;Merkus JW;Belkacemi Y;Petignat P;Schinagl DA;Coens C;Messina CG;Bogaerts J;Rutgers EJ
通讯作者：
Rutgers EJ
影响因子：
45.3
作者：
Fuchs, Michael;Goergen, Helen;Engert, Andreas
通讯作者：
Engert, Andreas
影响因子：
2.9
作者：
Haneef, Romana;Yavchitz, Amelie;Boutron, Isabelle
通讯作者：
Boutron, Isabelle
影响因子：
3.8
作者：
Claessens, Anouk K. M.;Bos, Monique E. M. M.;Erdkamp, Frans L. G.
通讯作者：
Erdkamp, Frans L. G.
影响因子：
8.8
作者：
Fujiwara, Yasuhiro;Mukai, Hirofumi;Nambu, Yoshihiro
通讯作者：
Nambu, Yoshihiro