Peters Jeroen P M, Hooft Lotty, Grolman Wilko, Stegeman Inge
Department of Otorhinolaryngology and Head & Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands; Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.
Dutch Cochrane Centre, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
PLoS One. 2015 Mar 20;10(3):e0122328. doi: 10.1371/journal.pone.0122328. eCollection 2015.
Randomised Controlled Trials (RCTs) are the preferred study design when comparing therapeutical interventions in medicine. To improve clarity, consistency and transparency of reporting RCTs, the Consolidated Standards of Reporting Trials (CONSORT) statement was developed.
(1) To assess the quality of reports and abstracts of RCTs in otorhinolaryngologic literature by using CONSORT checklists, (2) to compare the quality of reports and abstracts of otorhinolaryngologic RCTs between the top 5 general medical journals and top 5 otorhinolaryngologic journals, and (3) to formulate recommendations for authors and editors of otorhinolaryngologic ('ENT') journals.
Based on 2012 ISI Web of Knowledge impact factors, the top 5 general medical and ENT journals were selected. On 25 June 2014, using a highly sensitive Cochrane RCT filter and ENT filter, possibly relevant articles since January 1st, 2010 were retrieved and relevant RCTs were selected. We assessed how many CONSORT items were reported adequately in reports and abstracts and compared the two journal types.
Otorhinolaryngologic RCTs (n = 15) published in general medical journals reported a mean of 92.1% (95% confidence interval: 89.5%-94.7%) of CONSORT items adequately, whereas RCTs (n = 18) published in ENT journals reported a mean of 71.8% (66.7%-76.8%) adequately (p < 0.001). For abstracts, means of 70.0% (63.7%-76.3%) and 32.3% (26.6-38.0%) were found respectively (p < 0.001). Large differences for specific items exist between the two journal types.
The quality of reporting of RCTs in otorhinolaryngologic journals is suboptimal. RCTs published in general medical journals have a higher quality of reporting than RCTs published in ENT journals. We recommend authors to report their trial according to the CONSORT Statement and advise editors to endorse the CONSORT Statement and implement the CONSORT Statement in the editorial process to ensure more adequate reporting of RCTs and their abstracts.
在医学领域比较治疗性干预措施时，随机对照试验（RCT）是首选的研究设计。为提高RCT报告的清晰度、一致性和透明度，制定了《报告试验的统一标准》（CONSORT）声明。
（1）使用CONSORT清单评估耳鼻咽喉科文献中RCT报告和摘要的质量；（2）比较前5种综合医学期刊和前5种耳鼻咽喉科期刊中耳鼻咽喉科RCT报告和摘要的质量；（3）为耳鼻咽喉科（“ENT”）期刊的作者和编辑制定建议。
根据2012年科学信息研究所（ISI）的期刊影响因子，挑选出前5种综合医学期刊和耳鼻咽喉科期刊。2014年6月25日，使用高度敏感的Cochrane随机对照试验过滤器和耳鼻咽喉科过滤器，检索自2010年1月1日以来可能相关的文章，并挑选出相关的随机对照试验。我们评估了报告和摘要中充分报告的CONSORT项目数量，并比较了这两种期刊类型。
发表在综合医学期刊上的耳鼻咽喉科随机对照试验（n = 15）平均充分报告了92.1%（95%置信区间：89.5%-94.7%）的CONSORT项目，而发表在耳鼻咽喉科期刊上的随机对照试验（n = 18）平均充分报告率为71.8%（66.7%-76.8%）（p < 0.001）。对于摘要，平均充分报告率分别为70.0%（63.7%-76.3%）和32.3%（26.6%-38.0%）（p < 0.001）。两种期刊类型在特定项目上存在较大差异。
耳鼻咽喉科期刊中随机对照试验的报告质量欠佳。发表在综合医学期刊上的随机对照试验的报告质量高于发表在耳鼻咽喉科期刊上的随机对照试验。我们建议作者根据CONSORT声明报告他们的试验，并建议编辑认可CONSORT声明，并在编辑过程中实施CONSORT声明，以确保随机对照试验及其摘要得到更充分的报告。
