Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial.
Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial.
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DOI：
10.1186/s12916-015-0460-y
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发表时间：
2015-09-15
期刊：
影响因子：
9.3
通讯作者：
Ravaud P
中科院分区：
文献类型：
--
作者：
Barnes C;Boutron I;Giraudeau B;Porcher R;Altman DG;Ravaud P
不完整的报告是研究中经常出现的浪费。我们的目的是评估基于CONSORT声明及其扩展的书写辅助工具（WAT）对随机对照试验（RCT）报告完整性的影响。我们进行了一项“分稿”随机对照试验，并进行了盲法结局评估。参加者是公共卫生专业的硕士生和博士生。他们被要求在4小时内根据真实的RCT方案撰写手稿的方法部分，并向每位参与者提供不同的方案。方法部分分为六个不同的领域：“试验设计”，“随机化”，“盲法”，“参与者”，“干预”和“结果”。参与者必须为六个域中的随机三个域起草所有六个可以访问WAT的域。随机序列是计算机生成并隐藏的。对于每个领域，WAT包括相应CONSORT项目的提醒，详细说明所有应报告的关键要素的要点，以及良好报告的示例。控制干预包括没有提醒。主要结局是使用或不使用WAT撰写的所有领域的报告完整性平均总体评分（0-10分）。41名参与者撰写了41份不同的RCT方法部分手稿，对应于246个领域（41个协议中的每个协议六个）。分析了所有域。对于主要结局，报告完整性的平均（SD）总体评分在使用WAT时高于未使用WAT时：7.1（1.2）vs 5.0（1.6），平均（95%CI）差异为2.1（1.5-2.7; P <0.01）。除设盲和结局外，WAT在所有领域的报告完整性均显著较高。使用WAT可以提高报告RCT结果的手稿的完整性。Clinicaltrials.gov：//clinicaltrials.govNCT02127567，注册日期2014年4月29日首次收到）本文的在线版本（doi：10.1186/s12916-015-0460-y）包含补充材料，授权用户可使用。
Incomplete reporting is a frequent waste in research. Our aim was to evaluate the impact of a writing aid tool (WAT) based on the CONSORT statement and its extension for non-pharmacologic treatments on the completeness of reporting of randomized controlled trials (RCTs). We performed a ‘split-manuscript’ RCT with blinded outcome assessment. Participants were masters and doctoral students in public health. They were asked to write, over a 4-hour period, the methods section of a manuscript based on a real RCT protocol, with a different protocol provided to each participant. Methods sections were divided into six different domains: ‘trial design’, ‘randomization’, ‘blinding’, ‘participants’, ‘interventions’, and ‘outcomes’. Participants had to draft all six domains with access to the WAT for a random three of six domains. The random sequence was computer-generated and concealed. For each domain, the WAT comprised reminders of the corresponding CONSORT item(s), bullet points detailing all the key elements to be reported, and examples of good reporting. The control intervention consisted of no reminders. The primary outcome was the mean global score for completeness of reporting (scale 0–10) for all domains written with or without the WAT. Forty-one participants wrote 41 different manuscripts of RCT methods sections, corresponding to 246 domains (six for each of the 41 protocols). All domains were analyzed. For the primary outcome, the mean (SD) global score for completeness of reporting was higher with than without use of the WAT: 7.1 (1.2) versus 5.0 (1.6), with a mean (95 % CI) difference 2.1 (1.5–2.7; P <0.01). Completeness of reporting was significantly higher with the WAT for all domains except for blinding and outcomes. Use of the WAT could improve the completeness of manuscripts reporting the results of RCTs. Clinicaltrials.gov (http://clinicaltrials.govNCT02127567, registration date first received April 29, 2014) The online version of this article (doi:10.1186/s12916-015-0460-y) contains supplementary material, which is available to authorized users.