Kenny Kate P, Day Peter F, Sharif Mohammad O, Parashos Peter, Lauridsen Eva, Feldens Carlos Alberto, Cohenca Nestor, Skapetis Tony, Levin Liran, Kenny David J, Djemal Serpil, Malmgren Olle, Chen Yong-Jin, Tsukisboshi Misuhiro, Andersson Lars
Department of Paediatric Dentistry, School of Dentistry, University of Leeds, Leeds, UK.
Departments of Orthodontics, Eastman Dental Hospital and Croydon University Hospital, London, UK.
Dent Traumatol. 2018 Feb;34(1):4-11. doi: 10.1111/edt.12367. Epub 2017 Nov 16.
BACKGROUND/AIMS: There are numerous treatment options following traumatic dental injury (TDI). Systematic reviews of different treatments are challenging owing to the diversity of outcomes reported between clinical studies. This issue could be addressed through the development and implementation of a agreed and standardized collection of outcomes known as a core outcome set (COS). The aim of this study was to develop a COS for TDI in children and adults. The secondary aim was to establish what, how, when and by whom these outcomes should be measured.
The project was registered with Core Outcomes Measures in Effectiveness Trials (COMET). A web-based survey was developed to capture the opinions of dentists globally as to which outcomes should be recorded. A list of outcomes was entered into a Delphi Survey and scored by an Expert Working Group (EWG). The scoring was repeated, followed by conference calls to discuss, refine and finalize the COS. The EWG split into small groups of subject-specific experts to determine how, when and by whom each outcome would be measured.
The questionnaire was completed by 1476 dentists. The EWG identified 13 core outcomes to be recorded for all TDI's. An additional 10 injury-specific outcomes were identified. A table has been produced for each outcome detailing what, when, and how each outcome should be recorded.
A robust consensus process was used to develop an international COS for TDI in children and adults. This includes both generic and injury-specific outcomes across all identified domains.
背景/目的:创伤性牙损伤(TDI)后有多种治疗选择。由于临床研究报告的结果具有多样性,对不同治疗方法进行系统评价具有挑战性。这个问题可以通过开发和实施一个商定的、标准化的结果集(称为核心结局集,COS)来解决。本研究的目的是为儿童和成人的TDI制定一个COS。次要目的是确定这些结局应该测量什么、如何测量、何时测量以及由谁测量。
该项目已在有效性试验核心结局指标(COMET)注册。开展了一项基于网络的调查,以收集全球牙医对应记录哪些结局的意见。将一系列结局纳入德尔菲调查,并由一个专家工作组(EWG)进行评分。重复评分,随后进行电话会议以讨论、完善和最终确定COS。EWG分成特定主题的专家小组,以确定每个结局将如何、何时以及由谁进行测量。
1476名牙医完成了问卷。EWG确定了所有TDI都应记录的13项核心结局。还确定了另外10项特定损伤结局。为每个结局制作了一个表格,详细说明了每个结局应记录什么、何时记录以及如何记录。
采用了严格的共识过程来为儿童和成人的TDI制定一个国际COS。这包括所有已确定领域的通用结局和特定损伤结局。