Supplementary Material for: Development of a Multinational Clinical Practice Guideline: A Practical Structured Procedure

Introduction: The development of a clinical guideline is a challenging process. National and international organizations have established a variety of approaches, grading systems, evaluation scales, and voting modes; however, a practical description which illustrates all steps from starting the initiative to publication and dissemination of the guideline is usually not provided. We describe a structured guideline procedure that can be adjusted to the requirements of other multinational guidelines. Methods: A group of European specialist gastroenterological societies and national societies initiated a guideline for the use of breath tests in gastroenterology. A balance between scientific evidence and clinical experience was achieved by involving European specialist societies and physicians from 18 European countries. For persons contributing to the guideline process, different levels of involvement were defined. The tasks were assigned to different groups of persons, which formed scientific institutions. Results: We describe organizational structures and institutions, the stepwise approach, and illustrate the multistep guideline development procedure in a flowchart diagram that shows workflow and assigned responsibilities and provides details for the execution of each step, including timelines. The process is split into 4 phases: foundation, preparation, voting, and publication. Discussion: This structured procedure of a gastroenterological clinical practice guideline can serve as a blueprint for future multinational guideline initiatives and may aid future attempts to standardize and harmonize guideline development processes in gastroenterology and in other medical fields. Although the described procedure is for a diagnostic guideline, it may also be appropriate for therapeutic guidelines by adjusting the acceptance criteria for recommendations.

引言：临床实践指南的制定是一项极具挑战性的工作。全球各国及国际组织已构建了多种方法体系、分级标准、评价量表与投票模式，但目前鲜有能完整覆盖从指南发起、直至最终发布与传播全流程的实操性指南制定流程说明。本研究旨在介绍一套结构化的指南制定流程，该流程可适配其他跨国临床指南的制定需求。
方法：本研究联合欧洲消化专科协会联盟及多国国家学会，启动了一项针对消化科呼吸检测应用的临床指南制定工作。研究纳入了来自18个欧洲国家的消化专科协会与临床医师，以平衡科学证据与临床实践经验的权重。本研究对参与指南制定的人员设定了不同的参与层级，并将具体任务分配至不同的科学工作组与科研机构。
结果：本研究详细阐述了该指南制定的组织架构与科研团队，以及分阶段的执行路径，并通过流程图可视化展示了多步骤的指南制定流程，涵盖工作流、职责分配，同时明确了各执行步骤的细节与时间节点。该制定流程共分为四个阶段：奠基阶段、筹备阶段、投票阶段与发布阶段。
讨论：本研究提出的消化科临床实践指南结构化制定流程，可作为未来跨国临床指南制定项目的参考范式，亦有助于推动消化科乃至其他医学领域内指南制定流程的标准化与同质化建设。尽管本流程针对诊断类指南设计，但通过调整推荐意见的接受判定标准，同样可适用于治疗类临床指南的制定工作。