Borrelli Mimi R, Farwana Reem, Andrew Tom W, Chicco Maria, Abukhder Munir, Mobarak Dima, Thavayogan Rachel, Agha Riaz, Pidgeon Thomas E
Division of Plastic Surgery, Department of Surgery, Hagey Laboratory for Pediatric Regenerative Medicine, Stanford University School of Medicine, Stanford, CA.
School of Medical Education, University of Birmingham, Birmingham.
J Craniofac Surg. 2019 Jan;30(1):96-104. doi: 10.1097/SCS.0000000000004900.
Randomized controlled trials (RCTs) are gold standard assessments for healthcare interventions. The Consolidated Standards of Reporting Trials (CONSORT) statement was published to maximize RCT reporting transparency. The authors conducted a systematic review to assess current compliance of RCTs published within craniofacial surgery with the CONSORT statement.
The Thomson Reuters Impact Factor Report 2016 was consulted to identify craniofacial surgery journals. PubMed was used to search for recent RCTs published within the 5 journals identified. Two independent researchers assessed each study for inclusion and performed data extraction. The primary outcome was compliance of each RCT with the CONSORT statement. Secondary outcomes were the pathology and interventions examined, impact factor, multi-versus-single center, number of authors, and publication date.
Eighty-six studies met the inclusion criteria, across which a median of 56% (range 33%-94%) applicable CONSORT items were reported. The 5 least reported items were: trial design (3a); registration number and name of trial registry (23); who generated random allocation sequences, enrolled participants, and assigned participants to interventions (10); sample size determination (7a); mentioning "randomized trial" in the title (1a).
The compliance of craniofacial surgery RCTs with the CONSORT statement requires improvement. Areas in need are identified, and methods to improve reporting transparency, are discussed.
随机对照试验（RCTs）是医疗保健干预措施的金标准评估方法。《试验报告统一标准》（CONSORT）声明已发布，以最大限度地提高RCT报告的透明度。作者进行了一项系统评价，以评估颅面外科领域发表的RCTs目前对CONSORT声明的依从性。
查阅《2016年汤森路透期刊影响因子报告》以确定颅面外科期刊。使用PubMed在确定的5种期刊中搜索近期发表的RCTs。两名独立研究人员评估每项研究是否纳入并进行数据提取。主要结果是每项RCT对CONSORT声明的依从性。次要结果是所研究的病理学和干预措施、影响因子、多中心与单中心、作者数量以及发表日期。
86项研究符合纳入标准，其中报告的适用CONSORT项目中位数为56%（范围33%-94%）。报告最少的5个项目是：试验设计（3a）；试验注册号和试验注册名称（23）；谁生成随机分配序列、招募参与者并将参与者分配至干预措施（10）；样本量确定（7a）；标题中提及“随机试验”（1a）。
颅面外科RCTs对CONSORT声明的依从性需要提高。确定了需要改进的领域，并讨论了提高报告透明度的方法。
