The aim of this project is to reach international consensus on a minimal set of outcomes that should be measured and reported in all future clinical trials investigating inguinal hernia repair in children. The development process comprises three phases. First, we identify outcome domains associated with paediatric inguinal hernia repair from a patient perspective and through a systematic review of the literature using EMBASE, MEDLINE and the Cochrane Library databases. Second, we conduct a three-step Delphi study to identify and prioritise \'core\' outcomes for the eventual minimal set. In the third phase, an expert meeting is held to establish the final COS and develop implementation strategies with participants from all stakeholder groups: healthcare professionals, parents and patients\' representatives. The final COS will be reported in accordance with the COS-Standards for Reporting statement.
The medical research ethics committee of the Amsterdam UMC confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study and that full approval by the committee is not required. Electronic informed consent will be obtained from all participants. Results will be presented in peer-reviewed academic journals and at relevant conferences.
CRD42021281422.
方法:本项目的目的是在研究儿童腹股沟疝修补术的所有未来临床试验中应测量和报告的最低限度结果方面达成国际共识。开发过程包括三个阶段。首先,我们从患者的角度,通过使用EMBASE对文献进行系统回顾,确定与小儿腹股沟疝修补术相关的结局领域。MEDLINE和Cochrane图书馆数据库。第二,我们进行了三步Delphi研究,以确定并优先考虑最终最小集的“核心”结果。在第三阶段,举行了一次专家会议,以建立最终的COS并与所有利益相关者团体的参与者制定实施策略:医疗保健专业人员,家长和患者代表。最终COS将根据COS报告标准声明进行报告。
背景:阿姆斯特丹UMC的医学研究伦理委员会确认,《荷兰涉及人类受试者的医学研究法案》(WMO)不适用于本研究,并且不需要委员会的完全批准。将获得所有参与者的电子知情同意书。结果将在同行评审的学术期刊和相关会议上发表。
■CRD42021281422。