Department of Oncology and Metabolism, The Medical School, University of Sheffield, Sheffield, UK.
Colorectal Dis. 2023 Apr;25(4):695-706. doi: 10.1111/codi.16440. Epub 2022 Dec 22.
Crohn's anal fistula (CAF) is a complex condition, with no agreement on which patient characteristics should be routinely reported in studies. The aim of this study was to develop a core descriptor set of key patient characteristics for reporting in all CAF research.
Candidate descriptors were generated from published literature and stakeholder suggestions. Colorectal surgeons, gastroenterologists and specialist nurses in inflammatory bowel disease took part in three rounds of an international modified Delphi process using nine-point Likert scales to rank the importance of descriptors. Feedback was provided between rounds to allow refinement of the next ratings. Patterns in descriptor voting were assessed using principal component analysis (PCA). Resulting PCA groups were used to organize items in rounds two and three. Consensus descriptors were submitted to a patient panel for feedback. Items meeting predetermined thresholds were included in the final set and ratified at the consensus meeting.
One hundred and thirty three respondents from 22 countries completed round one, of whom 67.0% completed round three. Ninety seven descriptors were rated across three rounds in 11 PCA-based groups. Forty descriptors were shortlisted. The consensus meeting ratified a core descriptor set of 37 descriptors within six domains: fistula anatomy, current disease activity and phenotype, risk factors, medical interventions for CAF, surgical interventions for CAF, and patient symptoms and impact on quality of life.
The core descriptor set proposed for all future CAF research reflects characteristics important to gastroenterologists and surgeons. This might aid transparent reporting in future studies.
克罗恩病肛瘘(CAF)是一种复杂病症,对于研究中应常规报告哪些患者特征尚无共识。本研究的目的是制定一套核心描述符集,用于在所有CAF研究中报告关键患者特征。
候选描述符来自已发表的文献和利益相关者的建议。结直肠外科医生、胃肠病学家和炎症性肠病专科护士参与了三轮国际改良德尔菲法,使用九点李克特量表对描述符的重要性进行排名。各轮之间提供反馈,以便完善下一轮的评级。使用主成分分析(PCA)评估描述符投票模式。所得的PCA组用于在第二轮和第三轮中组织项目。将达成共识的描述符提交给患者小组征求反馈意见。符合预定阈值的项目被纳入最终集,并在共识会议上得到批准。
来自22个国家的133名受访者完成了第一轮,其中67.0%完成了第三轮。在11个基于PCA的组中,对97个描述符进行了三轮评级。40个描述符入围。共识会议批准了一个核心描述符集,包含37个描述符,分为六个领域:肛瘘解剖结构、当前疾病活动和表型、危险因素、CAF的医学干预、CAF的手术干预以及患者症状和对生活质量的影响。
为未来所有CAF研究提议的核心描述符集反映了对胃肠病学家和外科医生重要的特征。这可能有助于未来研究中的透明报告。