Ward Frank, Shiely Frances
Department of Nephrology, Tallaght University Hospital, Dublin, Ireland.
Health Research Board Clinical Research Facility, University College Cork, Ireland.
Contemp Clin Trials Commun. 2022 May 25;28:100924. doi: 10.1016/j.conctc.2022.100924. eCollection 2022 Aug.
Outcome reporting bias (ORB) is widely reported in the medical literature, but the contribution from published graphical illustrations is unknown. The aim of this study was to investigate the occurrence of ORB in contemporary nephrology clinical trials relating to the choice of outcomes reported through graphical illustrations.
An observational study was conducted using nephrology clinical trials searched from five high-impact medical journals from 2015 to 2020. Eligible trials reported a phase 2, 3 or 4 trial, contained at least one published outcome graphical illustration and were registered on a clinical trial registry. The primary outcome was the occurrence of ORB based on the choice of graphical illustrations in published trial manuscripts, deemed to be present if a graphical illustration displayed a secondary or unregistered outcome ahead of a trial's primary outcome, or if any unregistered trial outcome was presented as a graphical illustration.
In 75 eligible clinical trials, the primary outcome for ORB was present in 60% of the trials (n = 45). Occurrence of the primary outcome did not differ significantly based on trial sample size, funding model, trial phase, individual medical journal or publication year. An unregistered trial outcome was graphically illustrated in 93% (n = 42) of those clinical trials with ORB present.
Outcome reporting bias based on the choice of graphical illustration is common, driven primarily by graphical illustration of unregistered trial outcomes. More appropriate choice of outcomes for graphical illustrations by authors, coupled with both increased enforcement of CONSORT guidelines by medical journals and specific guidelines for graphical illustrations choice, are desirable to address these findings.
结果报告偏倚（ORB）在医学文献中广泛报道，但已发表的图表的影响尚不清楚。本研究的目的是调查当代肾脏病临床试验中通过图表报告的结果选择方面ORB的发生情况。
采用观察性研究，纳入2015年至2020年从五种高影响力医学期刊检索到的肾脏病临床试验。符合条件的试验报告了2期、3期或4期试验，包含至少一幅已发表的结果图表，并在临床试验注册库中注册。主要结果是基于已发表试验稿件中图表选择的ORB发生情况，如果图表在试验主要结果之前展示了次要或未注册的结果，或者如果任何未注册的试验结果以图表形式呈现，则认为存在ORB。
在75项符合条件的临床试验中，60%（n = 45）的试验存在ORB主要结果。主要结果的发生在试验样本量、资助模式、试验阶段、个别医学期刊或出版年份方面无显著差异。在存在ORB的那些临床试验中，93%（n = 42）的试验以图表形式展示了未注册的试验结果。
基于图表选择的结果报告偏倚很常见，主要由未注册试验结果的图表展示驱动。作者更恰当地选择图表结果，同时医学期刊加强对CONSORT指南的执行以及制定图表选择的具体指南，对于解决这些问题是可取的。
