The formulation of clinical questions is a critical starting point in the development of Clinical Practice Guidelines (CPGs), directly influencing their scope and recommendations. Although various health organizations have issued numerous guideline development manuals, their guidance on the specific processes and operational methods for formulating clinical questions remains generally insufficiently detailed. This often leads to misunderstandings and operational difficulties for guideline developers in practice.
To compare the methodological content related to the formulation of clinical questions in authoritative guideline development manuals from both domestic and international sources, and to provide insights and references for constructing a more systematic and operational clinical question formulation process.
The system systematically retrieved guidelines and manual development documents published by authoritative domestic and international institutions, with a search period spanning from January 2010 to May 2025. Data were screened based on clearly defined inclusion and exclusion criteria. Using a directed content analysis approach, the study employed the seven-step framework of WHO manuals as an analytical framework to encode, extract, and conduct summary analyses of clinically relevant content identified in the 11 included manuals. Comparative analyses were performed on key elements and processes.
A total of 11 manuals were included, comprising those from the WHO, the National Institute for Health and Care Excellence (NICE) in the UK, the Scottish Interhospital Guidelines Network (SIGN), and the Manual on Acupuncture in Traditional Chinese Medicine [World Federation of Acupuncture Societies (WFAS), National Administration of Traditional Chinese Medicine (NATCM)]. Comparative analysis revealed that all manuals recommended the use of the PICO framework for problem formulation, but differences existed in the definition and application of core concepts such as "scope","issues"and "problems". Only a few manuals provided step-by-step procedural recommendations, while most offered only general guidelines. Regarding the sources of clinical questions, clinical surveys and literature reviews were included. In terms of outcome measure importance evaluation, manuals such as WHO explicitly adopted a 9-point scoring system.
Current guideline manuals provide insufficient guidance in terms of standardization and refinement for the clinical question formulation stage. Future efforts should focus on constructing a systematic, step-by-step operational framework that integrates multi-source clinical question collection, PICO-structured formulation, pre-assessment of evidence quality, and incorporation of patient values. Through systematic comparison, this study clarifies the key components and directions for building such a framework, offering direct methodological references for enhancing the scientific rigor, practicality, and efficiency of guideline development.
Observer-reported outcome (ObsRO), which records patients' observable behavioral signs and symptoms from a third-party perspective, has become a key technical support for health management in special populations such as infants, young children, and individuals with cognitive impairments. This paper reviews the international development context and trends of ObsRO, as well as the progress and bottlenecks in domestic localization practices; it reveals the core value of ObsRO in primary healthcare and its role in supporting the "prevention-treatment-rehabilitation" full-cycle management; and it explicitly identifies three key pathways for future breakthroughs: developing localized tools adapted to the Chinese model, integrating cutting-edge digital technologies, and improving policy support and interdisciplinary collaboration mechanisms. It provides a theoretical basis for the standardized application of ObsRO under the "Healthy China" strategy, emphasizing its practical potential to enhance the quality of primary healthcare services and the effectiveness of health management for special populations through the integration of cutting-edge technologies.
Clinical practice guidelines are able to regulate the clinical behavior of clinicians and provide appropriate suggestions and references for patients. In recent years, the number of clinical practice guidelines in China has been on the rise. However, the quality of the guidelines, especially traditional Chinese medicine (TCM) is very uneven. At present, there have been some studies on the application of guideline evaluation tools, but studies on the evaluation of TCM guidelines are scant.
To evaluate the selected TCM clinical practice guidelines using two guideline evaluation tools, and to analyze the important dimensions influencing the quality of TCM clinical practice guidelines.
TCM clinical practice guidelines for common and frequently occurring diseases in the Gastroenterology, Pediatrics, Orthopedics and Gynecology were searched in China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP and SinoMed databases from November 1, 2023 to June 30, 2024. Two guidelines of each specialty were selected after a negotiation with 2 clinical doctors. Journals that published the guidelines, publishing institutions/groups, tools used for evidence grading and recommendation intensity, number of references, number of authors, number of experts formulated, whether to update the guidelines, the evaluation results of the AGREE-China evaluation, the evaluation results of the list of suggestions for quality evaluation of TCM clinical practice guidelines, and the evaluation time of the guidelines were collected.
Among the 8 guidelines evaluated, 6 guidelines were strongly recommended after the AGREE-China evaluation, and only 3 guidelines had more than half of the reports after the evaluation of the list of suggestions for quality evaluation of TCM clinical practice guidelines. The median time required for AGREE-China evaluation was 22.0 min. The median time required for the list of suggestions for quality evaluation of TCM clinical practice guidelines was 18.8 min.
Although AGREE-China evaluates 6 high-quality guidelines, the tool lacks an evaluation of TCM content and takes a relatively long time. Although the list of suggestions for the quality evaluation of TCM clinical practice guidelines has increased the content of TCM evaluation and shortened the time consuming, only three guideline reports have reached more than half in the number, and the evaluation results are not quantitative and intuitive. Therefore, there are still some inconveniences in clinical use.
Surrogate endpoints are frequently used to substitute for primary outcomes in randomized controlled trials to shorter trial duration, reduce sample size and etc. But some surrogate endpoints would increase uncertainty of the intervention's true effect and unreliable in revealing intervention harms. We do need better reporting of trials that rely on surrogate endpoints. The SPIRIT-Surrogate and CONSORT-Surrogate provides the minimum reporting requirements for trials that use surrogate endpoints. Those extension checklists help to improve transparency, usefulness of trial findings, and ultimately reduce research waste. We interpreted these two guidelines with the aim of providing reference for practitioners and drawing their attention to surrogate endpoints.
While traditional centralized clinical studies often face barriers such as geographic constraints, lack of participant diversity, and logistical challenges, modern decentralized clinical trials (DCT) are an innovative approach to clinical research that leverages digital health technologies and real-world environments to improve inclusiveness and accessibility of clinical research, streamline trial process, reduce costs, put "patient-centeredness" into practice in clinical research, and provide clinical evidence with good extrapolation and reliability. This paper introduces the development history of DCT at home and abroad, the similarities and differences between DCT and traditional clinical research, the advantages and challenges, on the basis, discusses the prospects for the application of DCT in the real world.
