PDF(Pubmed)
Abstract：
In children, open inguinal hernia repair has been the gold standard for treatment, but with recent technical advancements in laparoscopy, laparoscopic hernia repair is gaining popularity. Despite available results from comparative studies, there is still no consensus regarding the superiority of open versus laparoscopic treatment strategy. An important reason for lack of consensus is the large heterogeneity in the trials\' reported outcomes and outcome definitions, which limits comparisons between studies and precludes conclusions regarding the superiority of treatment strategies. The development and implementation of a core outcome set (COS) is a solution for this heterogeneity in the selection, measurement and reporting of trial outcome measures across studies. Currently, there is no COS for the treatment of paediatric inguinal hernia.
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.
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.
摘要：
背景：在儿童中，开放式腹股沟疝修补术一直是治疗的金标准,但是随着腹腔镜检查技术的进步，腹腔镜疝修补术越来越受欢迎。尽管有比较研究的结果，关于开腹与腹腔镜治疗策略的优越性仍未达成共识.缺乏共识的一个重要原因是试验报告的结果和结果定义的巨大异质性，这限制了研究之间的比较，并排除了有关治疗策略优越性的结论。核心结果集（COS）的开发和实施是选择中这种异质性的解决方案，跨研究的试验结果测量和报告。目前,没有用于治疗小儿腹股沟疝的COS。
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。
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。
