With the rapid increase of integrated Traditional Chinese Medicine (TCM) and Western medicine guidelines, their methodological development must integrate international evidence-based frameworks while closely aligning with localized clinical practices. As a pivotal step in guideline formulation, the scientific rigor and practical relevance of clinical problem structuring directly determine guideline quality, necessitating a systematic synthesis of its methodologies and influencing factors.

To review domestic and international guideline development manuals, summarizing the methods and influencing factors for clinical question formulation, and provide references for the formulation of clinical issues.

This study involved a comprehensive search for clinical practice guideline methodological guidance manuals through databases such as PubMed, Embase, Web of Science, CNKI, Wanfang Data, SinoMed, and VIP, as well as web searches. The search period covered from the inception of these databases to May 2025. Relevant data on clinical questions were extracted from the manuals, and descriptive analysis was used for collation and summarization.

A total of 53 domestic and international guideline development manuals were collected. The study found that methods for collecting clinical questions primarily include internal decision-making by guideline teams, literature search, and solicitation of opinions from multiple stakeholders. Factors influencing the determination of clinical questions mainly include policy and clinical decision relevance, target user positioning, clinical necessity, question controversy, anticipated outcome positioning, evidence support, and feasibility. The decomposition formats for clinical questions have evolved from the PICO framework into nine variations, including PICOM, PICOT, PICOTS, PICOTT, PECOT, PInGO, PERO, PIPOH, and DSCO.

The formulation of clinical questions should be centered on the actual needs of clinical practice, utilizing multi-channel, multi-angle, and multi-faceted information collection strategies to enhance the objectivity and comprehensiveness of the questions. The deconstruction of clinical questions using formats such as PICO can enhance the pertinence and feasibility of the final recommendations in the guidelines, guaranteeing the quality of the guidelines. This provides a reference for the development of guidelines in Traditional Chinese Medicine and integrated traditional Chinese and Western medicine.

随着中医/中西医结合指南的快速增多，其方法学构建必须兼容国际循证框架并深度融合本土诊疗实践。作为指南制定的核心环节，临床问题构建的科学性与适用性直接与指南质量相关，亟须系统总结其提出方法及影响因素。

检索国内外指南制定方法学手册，总结指南制定方法学手册中临床问题提出方法及影响因素，为临床问题的研制提供参考。

本文通过PubMed、Embase、Web of Science、中国知网、万方数据知识服务平台、中国生物医学文献服务系统和维普网等数据库检索结合网页检索，搜集临床实践指南制定方法学手册。检索时间为建库至2025年5月，提取指南制定方法学手册中关于临床问题提出的相关资料，采用描述性分析进行整理和归纳。

共收集了国内外53篇指南制定方法学手册，总结临床问题的收集主要有指南小组内部决策、文献检索及多主体意见征询等方法；影响临床问题的确定主要有政策及临床相关性、目标用户定位、临床所需性、问题争议性、预期结果定位、证据支持度、可执行性等因素；临床问题的解构格式以人群、干预、对照、结局（PICO）为基础衍生出如人群、干预、对照、结局、方法学（PICOM）；人群、干预、对照、结局、时间（PICOT）；人群、干预、对照、结局、时间、环境（PICOTS）；人群、干预、对照、结局、时间、研究类型（PICOTT）；患者/消费者/参与者、暴露、对照、结局、时间（PECOT）；人群、待测指标、金标准、结局（PInGO）；人群、暴露、参照、结局（PERO）；人群、干预、专业人员、结局、医疗环境（PIPOH）；中成药品种、特定疾病阶段、对照，特定结局（DSCO）共9种。

临床问题的提出应以临床实践的实际需求为核心，通过多渠道、多角度、多方位的信息收集策略来增强问题的客观性与全面性，利用PICO等格式深入解构临床问题以提升指南最终建议的针对性和可行性，保障指南质量，为中医/中西医结合指南制定提供参考。