Assmann Sadé, Keszthelyi Daniel, Kleijnen Jos, Kimman Merel, Anastasiou Foteini, Bradshaw Elissa, Carrington Emma, Chiarioni Giuseppe, Maeda Yasuko, Muris Jean, Pohl Daniel, Rydningen Mona, Vaizey Carolynne, Breukink Stephanie
Department of Surgery and Colorectal Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.
Division of Gastroenterology-Hepatology, Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.
Int J Colorectal Dis. 2021 Mar;36(3):617-622. doi: 10.1007/s00384-021-03865-2. Epub 2021 Feb 2.
Faecal incontinence (FI) is estimated to affect around 7.7% of people. There is a lack of uniformity in outcome definitions, measurement and reporting in FI studies. Until now, there is no general consensus on which outcomes should be assessed and reported in FI research. This complicates comparison between studies and evidence synthesis, potentially leading to recommendations not evidence-based enough to guide physicians in selecting an FI therapy. A solution for this lack of uniformity in reporting of outcomes is the development of a Core Outcome Set (COS) for FI. This paper describes the protocol for the development of a European COS for FI.
Patient interviews and a systematic review of the literature will be performed to identify patient-, physician- and researcher-oriented outcomes. The outcomes will be categorised using the COMET taxonomy and put forward to a group of patients, physicians (i.e. colorectal surgeons, gastroenterologists and general practitioners) and researchers in a Delphi consensus exercise. This exercise will consist of up to three web-based rounds in which participants will prioritise and condense the list of outcomes, which is expected to result in consensus. A consensus meeting with participants from all stakeholder groups will take place to reach a final agreement on the COS.
This study protocol describes the development of a European COS to improve reliability and consistency of outcome reporting in FI studies, thereby improving evidence synthesis and patient care.
This project has been registered in the COMET database on the 1st of April 2020, available at http://www.comet-initiative.org/Studies/Details/1554 . The systematic review has been registered on the PROSPERO database on the 31st of August 2020, available at https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=202020&VersionID=1381336 .
据估计，大便失禁（FI）影响约7.7%的人群。FI研究在结局定义、测量和报告方面缺乏一致性。到目前为止，对于FI研究应评估和报告哪些结局尚无普遍共识。这使得研究之间的比较和证据综合变得复杂，可能导致所提建议缺乏足够证据来指导医生选择FI治疗方法。解决结局报告缺乏一致性的一个办法是制定FI核心结局集（COS）。本文描述了欧洲FI COS的制定方案。
将进行患者访谈和文献系统综述，以确定以患者、医生和研究人员为导向的结局。使用COMET分类法对结局进行分类，并在德尔菲共识练习中向一组患者、医生（即结直肠外科医生、胃肠病学家和全科医生）和研究人员提出。该练习将包括最多三轮基于网络的环节，参与者将对结局列表进行优先排序和精简，预计将达成共识。将与所有利益相关者群体的参与者举行共识会议，以就COS达成最终协议。
本研究方案描述了欧洲COS的制定，以提高FI研究中结局报告的可靠性和一致性，从而改善证据综合和患者护理。
该项目已于2020年4月1日在COMET数据库中注册，可在http://www.comet-initiative.org/Studies/Details/1554获取。系统综述已于2020年8月31日在PROSPERO数据库中注册，可在https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=202020&VersionID=138那么，你对这段翻译满意吗？如果你还有其他需求，请随时告诉我。1336获取。
