BackgroundMany authors choose to work with professional medical writers when reporting the results of clinical trials. We conducted a systematic review to examine the relationship between professional medical writing support (PMWS) and the quality, ethics and timeliness of publications reporting clinical trials.MethodsUsing terms related to ‘medical writer’ and ‘observational study’, we searched MEDLINE and Embase (no date limits), as well as abstracts and posters from meetings of the International Society for Medical Publication Professionals (ISMPP; 2014–2018). We also hand-searched the journals Medical Writing and The Write Stuff (2014–2018) and the bibliographies of studies identified in the electronic searches. We screened the results to identify studies that compared the quality, ethics and timeliness of clinical trial publications written with and without declared PMWS.ResultsOur searches identified 97 potentially relevant studies, of which 89 were excluded during screening and full paper review. The remaining eight studies compared 849 publications with PMWS with 2073 articles developed without such support. In these eight studies, PMWS was shown to be associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines (in 3/3 studies in which this was assessed), publication in journals with an impact factor (one study), a higher quality of written English (one study), and a lower likelihood of reporting non-pre-specified outcomes (one study). PMWS was not associated with increased adherence to CONSORT for Abstracts guidelines (one study) or with the impact of published articles (mean number of citations per year, mean number of article views per year and Altmetric score; one study). In studies that assessed timeliness of publication, PMWS was associated with a reduced time from last patient visit in clinical trials to primary publication (one study), whereas time from submission to acceptance showed inconsistent results (two studies).ConclusionsThis systematic review of eight observational studies suggests that PMWS is positively associated with measures of overall quality of reporting of clinical trials and may improve the timeliness of publication.

中文翻译：

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专业医学写作支持和临床试验报告的质量、伦理和及时性：系统评价

背景许多作者在报告临床试验结果时选择与专业医学作家合作。我们进行了系统评价，以检查专业医学写作支持 (PMWS) 与报告临床试验的出版物的质量、伦理和及时性之间的关系。方法使用与“医学作家”和“观察性研究”相关的术语，我们搜索了 MEDLINE 和 Embase (没有日期限制），以及来自国际医学出版专业协会（ISMPP；2014-2018）会议的摘要和海报。我们还手动搜索了医学写作和写作材料（2014-2018）期刊以及电子搜索中确定的研究书目。我们筛选了结果以确定比较质量的研究，有和没有声明的 PMWS 的临床试验出版物的伦理和及时性。结果我们的搜索确定了 97 项可能相关的研究，其中 89 项在筛选和全文审查期间被排除在外。其余八项研究将 849 篇出版物与 PMWS 与没有此类支持的 2073 篇文章进行了比较。在这八项研究中，PMWS 被证明与增加对联合报告试验标准 (CONSORT) 指南的依从性有关（在 3/3 的研究中对此进行了评估）、在具有影响因子的期刊上发表（一项研究）、书面英语质量更高（一项研究），报告非预先指定结果的可能性更低（一项研究）。PMWS 与增加对 CONSORT for Abstracts 指南的依从性（一项研究）或与已发表文章的影响（每年平均引用次数、每年平均文章浏览次数和 Altmetric 评分；一项研究）无关。在评估发表及时性的研究中，PMWS 与从最后一次临床试验患者就诊到初次发表的时间缩短有关（一项研究），而从提交到接受的时间显示出不一致的结果（两项研究）。结论这项对八项观察性观察的系统评价研究表明，PMWS 与临床试验报告的整体质量测量呈正相关，并可能提高发表的及时性。