BACKGROUND:Although guidelines focus predominantly on individual diseases, some dedicated guidelines and recommendations exist for common combinations of comorbidities. Using diabetes, coronary heart disease (CHD) and stroke as an example, we aimed to assess the current status and quality of such guidelines. METHODS:We systematically searched literature databases, Google, guideline platforms, and websites of relevant organizations. We included guidelines published between 2020 and 2024 that addressed at least two of the following diseases: diabetes, CHD, and stroke; and included drug therapy interventions. We extracted the recommendations on drug therapy and sources of the supporting evidence, and assessed the quality of the guidelines using AGREE II and RIGHT with the help of a large language model based tool. RESULTS:We identified 82 guidelines: 64 focused on one disease with recommendations on comorbidities, and 18 specifically addressed a combination of diseases. China was the most frequent country of origin (n = 50, 61.0%). The methodological and reporting quality of these guidelines was moderate on average. For most guidelines (n = 54, 65.9%), the primary focus was on diabetes. We grouped the recommended drug therapies for patients with combinations of these diseases into four main categories: anti-diabetic therapy, antihypertensive therapy, lipid-lowering therapy, and anticoagulant therapy. Most recommendations were supported by RCTs, but only a third of the guidelines referred to studies done in multimorbid patients. CONCLUSION:Most recommendations related to multimorbidity were found in guidelines focusing on a single target disease, and supporting evidence from multimorbid patients was rare. More primary evidence from multimorbid patients is needed.
OBJECTIVES:The use of guidelines in multimorbidity-related practice has not yet been extensively investigated. We aimed to explore how health-care professionals use guidelines when managing individuals with multimorbidity. METHODS:We conducted an exploratory survey among a convenience sample of medical professionals with clinical experience. The questionnaire addressed whether and how different types of guidelines are used in multimorbidity-related practice, the reasons for not using specific types of guidelines, and other approaches to inform multimorbidity practice. It was distributed through the investigators' contact networks. The results were presented descriptively. RESULTS:We received 311 valid responses: 136 from the World Health Organization European Region, 137 from the Western Pacific Region, and 38 from other regions. Most participants were familiar with the concept of multimorbidity (n = 245, 79%). Among the 269 respondents who reported using guidelines in multimorbidity practice, 124 (46%) used guidelines specifically focusing on combinations of diseases, and 148 (55%) multiple single-disease guidelines together. Lack of availability was the main reason for not using guidelines that address multimorbidity itself, and the high number of guidelines (n = 76, 40%) and possible interactions between conditions or treatments (n = 62, 38%) for not using single-disease guidelines. Respondents frequently consult experts or refer to systematic reviews and primary studies when existing guidelines do not meet their needs. The development of a tool or method to guide the use of multiple guidelines ranked highest among possible actions to improve multimorbidity practice. CONCLUSION:Although the medical professionals in our sample were generally familiar with the use of guidelines, there are many unmet needs and tool gaps related to guideline-informed multimorbidity-related practice.
ObjectiveTo sort, summarize, and introduce key terms related to guideline reporting, evaluation, dissemination, implementation, and updating.MethodsWe systematically searched guideline development manuals and methodological literature from database inception to October 25, 2024. Terms related to guideline reporting, updating, evaluation, and implementation were extracted, standardized, and finalized through a structured consensus process.ResultsA total of 13 guideline manuals and 32 methodological articles were included, yielding 14 core terms with standardized definitions.ConclusionsThis article introduces key terms such as reporting standards, external review, and research gaps across guideline development phases to promote concept application and deepen readers' understanding of guideline development.
BackgroundThe burden of multimorbidity is increasing globally, which complicates the use of guidelines in clinical practice and health care: practitioners may need to increasingly refer to multiple guidelines with potentially conflicting recommendations. ObjectiveWe aim to develop a guideline-based decision support framework for the management of patients with multimorbidity to help clinicians efficiently evaluate, select, and adapt recommendations focusing on the different comorbidities and aspects of multimorbidity. MethodsWe will conduct the project using the following steps: (1) needs assessment (searching published literature and documents on guideline use in multimorbidity care through the study initiators, and assessing the necessity of developing a comprehensive decision-making framework focusing on multimorbidity in a broad sense), (2) establishing international working groups (a coordination team, an evidence support group, and a consensus group) by leveraging existing participants’ networks and inviting experts with relevant academic publications or activities, (3) conducting literature reviews of multimorbidity guidelines and original qualitative research involving interest-holders in multimorbidity care and/or guideline development to formulate an initial draft framework, (4) a consensus process including an expert survey and a consensus meeting, (5) formulating and releasing the final framework, and (6) testing the framework (collecting feedback through educating health professionals in different settings and applying the framework in practice to evaluate and improve it). We plan to complete the project within 3 years. ResultsThe project has started in March 2024 and is due to conclude in June 2026. As of May 2025, we have finished the literature reviews and qualitative studies and are currently conducting the first round of the expert survey. ConclusionsThis framework will help clinicians from all levels of health care institutions to make decisions in the management of patients with multimorbidity based on the latest available evidence, and to reduce potential health risks to their patients. One limitation of this framework is that such a broad framework may not fully fit all disease combinations or realistic situations. To reduce the degree of inapplicability, after completion of the framework, we will continue to monitor its use with regular updates as needed. International Registered Report Identifier (IRRID)DERR1-10.2196/63339
Objective To promote the development of high-quality health standards in China and summarize the characteristics of global health standards management systems and development processes. Methods We conducted a systematic search of relevant databases and the websites of standardization institutions. A descriptive method was used to analyze the basic characteristics of the standard management systems and development processes. Results The majority of the investigated countries and organizations primarily implement voluntary standards, with the exception of Chinese and the European Committee for Standardization that enforce compulsory standards. All countries and organizations have health standards at the national, group, and enterprise levels. In China and Japan, standards authorities are subordinate to the government, while in other countries or organizations, they operate as independent civil societies. The development process for health standards generally involves five stages: 'Project/Proposal → Draft → Enquiry → Review → Publication'. However, the specific steps in the development of health standards vary across different countries and organizations. Furthermore, China ranks high in the number of both standards and health standards issued, but the proportion of health standards is only 2.06%. Conclusions There are significant differences between China and other countries in terms of the management system and development process of health standards. To promote the management and development of high-quality health standards in China, we recommend promoting the coordination mechanism for standard development, increasing efforts to publicize standards and evaluate the implementation effect, strengthening the construction of personnel for the development of health standards, optimizing the efficiency of standard development and improving the internationalization level of health standards.
Diagnostic criteria, as a critical component of clinical practice guidelines, play a direct role in guiding clinicians' diagnostic and treatment decisions. Although China has increasingly emphasized the development and updating of clinical guidelines in recent years, research focusing on the diagnostic criteria within these guidelines remains limited. This paper aims to explore the types of diagnostic criteria, the issues they present, and the processes involved in their formulation. Based on this analysis, suggestions are proposed to improve the recommendation and application of diagnostic criteria in Chinese guidelines.
Background:The STAR (Scientific, Transparent, and Applicable Rankings) working group conducts regular evaluations of Chinese guidelines and consensus statements. This study gathered insights from STAR working group members using qualitative interviews.Methods:From March to August 2023, members of the STAR specialist committees were interviewed using semi-structured interview outline. The interviewees were selected through purpose-based sampling. Subject analysis was employed to summarize the findings.Results:We conducted interviews with 37 members from 36 committees and summarized the contents into four main themes and 16 specific topics. The value of STAR in enhancing the development and selection of high-quality guidelines in China was commonly mentioned. Challenges identified included the lack of resources and suboptimal organizational structures, collaboration, and evaluation efficiency. Suggestions for the STAR tool included developing extensions for different guideline types, adjusting certain items, and better covering guideline applicability. The promotion of STAR and the consideration of an international committee for global outreach were also highlighted.Conclusion:STAR has exerted a substantial influence on the evaluation of Chinese guidelines, and the insights gained from interviews offer valuable directions for its further enhancement.
OBJECTIVES:Patient and public versions of guidelines (PVGs) have gradually gained wide recognition and attention from the public and the society due to their scientific, professional, and authoritative characteristics. This study aims to survey the awareness and knowledge of PVGs among stakeholders in China. STUDY DESIGN AND SETTING:This was a cross-sectional survey among stakeholders (guideline developers, clinicians, journal editors, patients, and the public) in China. We self-designed the questionnaire and distributed it through the Questionnaire Star platform. The primary outcomes were awareness of PVGs and opinions about the development methodology, writing, dissemination, and implementation of PVGs. The Kruskal-Wallis H test and post hoc multiple comparison tests were used to compare the levels of awareness of PVGs between different subgroups of respondents. RESULTS:A total of 1319 valid questionnaires were collected: 722 from guideline developers, 136 from clinicians, 83 from journal editors, 284 from patients, and 94 from members of the public. Of all respondents, 253 (19.2%) had not heard of PVGs, 349 (26.5%) had heard of PVGs but had no further knowledge, 475 (36.0%) had some knowledge of PVGs, and 242 (18.3%) were familiar with or had participated in the development of PVGs. Guideline developers, clinicians, and journal editors had higher awareness than patients and the public. Higher education and older age also correlated with higher awareness of PVGs. More than half (52.9%) of guideline developers considered that both rewriting of the source guidelines and direct development as independent documents were appropriate methods for developing PVGs. The survey respondents agreed that clinicians (97.3%), guideline methodologists (76.6%), representatives of patients and the public (74.5%), and medical editors or writers (63.4%) should participate in the development of PVGs. More than 80% of the respondents agreed that the quality of evidence and strength of recommendations should be presented; however, there was no consensus in the form of presentation. CONCLUSIONS:The level of awareness of PVGs among stakeholders in China is relatively low and differs between different stakeholder groups, but the majority of key stakeholders have a positive attitude toward PVGs. The collection of the perspectives and opinions on the development methods, writing, dissemination, and implementation provides a key reference and basis for the future optimization and improvement of PVGs development.
The development of patient and public versions of guidelines (PVGs) in China is still in its early stages. The aim of this article is to systematically identify the PVGs published or released in China, analyse their development methods, and assess their reporting quality. We searched five major literature databases and conducted supplementary searches to identify all PVGs published or released by 8 January 2023 in China. After screening the literature according to the inclusion and exclusion criteria, we analysed the development methodology and evaluated the reporting quality of the included PVGs using the Reporting Items for Practice Guidelines in Healthcare-Public or Patient Versions of Guidelines (RIGHT-PVG). We reported this systematic review in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A total of 3795 records were first identified, and 17 PVGs were included. Nine PVGs reported their development methodology: seven used de novo development (similar to developing clinical practice guidelines [CPGs]), and two rewrote the recommendations of an existing CPG. The reporting quality differed substantially between the PVGs. The PVGs adhered to between 8 and 16 (47.1%–94.1%) of the 17 RIGHT-PVG items, with a median of 9. All PVGs specified the topic addressed in the PVGs, introduced the target condition, described the purpose, scope and target users and had precise recommendations. In contrast, none of the PVGs listed questions for patients to ask their healthcare providers. Only few PVGs have so far been released in China. Most PVGs were developed de novo from the evidence, while some were instead rewritten from an existing CPG. In addition, we encourage PVGs developers to follow RIGHT-PVG checklist when writing the guidelines in the future.
OBJECTIVES:To investigate the frequency, determinants, stages, and barriers of patient and public involvement (PPI) in systematic reviews and to explore its association with the dissemination of reviews. STUDY DESIGN AND SETTING:We examined systematic reviews that required the inclusion of a PPI declaration, published in The BMJ between January 1, 2015, and December 31, 2022. Multivariable analysis was used to assess the association between PPI and key variables. We investigated the association between PPI and the dissemination of reviews using Altmetric scores, citations, and full-text views. RESULTS:A total of 217 systematic reviews were included, of which 56 (25.8%, 95% CI 20.0%-31.6%) included PPI, with a steady increase from 5.9% (1/17) in 2015 to 44.4% (4/35) in 2022. Of the 217 systematic reviews, 160 (73.7%) involved methodologists as co-authors. Factors significantly associated with a higher proportion of PPI included the publication year after 2019 (adjusted odds ratio [aOR] 2.46, 95% CI 1.26-4.83), the involvement of methodologist (aOR 3.08; 95% CI 1.27-7.47), and being led by researchers from high-income countries (aOR 5.47; 95% CI 1.23-24.30). Reviews that included PPI had higher Altmetric scores per month (6.6 vs 3.4, P = .002) and more monthly full-text (1048.6 vs 636.5, P < .001) and PDF (217.7 vs 129.0, P < .001) views than reviews without PPI. However, there was no difference in the monthly citations (2.2 vs 2.0, P = .365) between reviews with and without PPI. CONCLUSION:The proportion of systematic reviews reporting PPI in The BMJ has increased over time, possibly due to journal policies, but it still remains at a low level. Reviews led by researchers from high-income countries or involving methodologists are associated with a higher frequency of PPI within The BMJ. Furthermore, reviews incorporating PPI within The BMJ have a higher potential for broad dissemination.
BACKGROUND:As the population is aging, multimorbidity has become an increasingly important global health challenge. Clinical practice guidelines are essential references to guide daily practice for health care providers. This systematic review aims to assess whether existing multimorbidity guidelines adhered to the principles outlined in a previously developed framework for multimorbidity management recommendations, Ariadne, and evaluate their methodological and reporting quality. METHODS:We systematically searched six literature databases and nine guideline platforms from their inception until September 30, 2024. We included guidelines and guideline-like documents on multimorbidity and polypharmacy. Language was limited to English and Chinese. We extracted data related to basic information and guideline development methodology, and categorized guideline recommendations based on the Ariadne framework. We used the Appraisal of Guidelines, Research and Evaluation II (AGREE II) instrument and Reporting Items for practice Guidelines in HealThcare (RIGHT) checklist to evaluate the methodological and reporting quality of the guidelines, respectively. RESULT:Our systematic review identified 20 eligible guidelines, of which 10 focused on multimorbidity, eight on polypharmacy, and two covered both topics. The mean overall AGREE II score was 27.9 % and the mean compliance rate to the RIGHT reporting checklist 35.1 %. Individualized management was the most frequently addressed of the five steps of the Ariadne framework (n=18 guidelines, 90.0 %), followed by interaction assessment (n=17, 85.0 %). CONCLUSION:The methodological and reporting quality of multimorbidity guidelines were suboptimal. The recommendations of these guidelines covered primarily the management process of multimorbid patients. Future guidelines should pay more attention to the scientific quality of the development methodology and the feasibility of implementing the guidelines in practice. FUNDING:Research Unit of Evidence-Based Evaluation and Guidelines (2021RU017), Chinese Academy of Medical Sciences, School of Basic Medical Sciences, Lanzhou University, Lanzhou, Gansu, China.
ObjectiveAs a large and populous country, China releases a high number of diagnostic criteria. However, the published diagnostic criteria have not yet been systematically analyzed. Therefore, the aim of this study is to investigate the characteristics, development methods, reporting quality, and evidence basis of diagnostic criteria published in China.MethodsWe searched five databases for diagnostic criteria from their inception until July 31, 2023. All diagnostic criteria were screened through abstract and full-text reading, and included if satisfying the prespecified criteria. Two researchers independently extracted data on the characteristics, development methods, reporting quality, and evidence basis of diagnostic criteria.ResultsA total of 143 diagnostic criteria were included. In terms of development methods, the proportions of diagnostic criteria that involved a systematic literature search (n = 2; 1.4%; 95% confidence interval (CI), 0.4% to 5.0%), adoption of formal consensus methods (n = 4; 2.8%; 95% CI, 1.1% to 7.0%), and criteria validation (n = 9; 6.3%; 95% CI, 3.3% to 11.5%) were relatively low. Regarding reporting quality, the average compliance with the ACCORD checklist was 5.1%; none of the diagnostic criteria reported on registration, expert inclusion criteria, expert recruitment process, or consensus results. A majority (58.7%; 95% CI, 50.6% to 66.5%) of criteria did not cite any research, and only one (0.7%; 95% CI, 0.1% to 3.9%) criterion was derived from a systematic review. Moreover, only 16.1% (95% CI, 11.0% to 23.0%) of diagnostic criteria used evidence from the Chinese population.ConclusionThe diagnostic criteria developed in China exhibit serious flaws, particularly in evidence retrieval, formation of expert panels, consensus methods, and validation. Additionally, only few diagnostic criteria used a systematic synthesis of the evidence or evidence from the China. There is an urgent need to enhance the methodology for developing diagnostic criteria.
This study conducted a comprehensive assessment of the current state of health standards in China by systematically searching the National Health Commission's Health Standards website and variousliterature databases. By identifying key issues within the domain of health standards, this study subsequently presentstargeted strategies and recommendations. These findings serve as a valuable reference for refining China's health standard system and developing policies related to health standards.
ObjectiveTo analyze the development method of existing clinical practice guidelines in primary care to inform the future development of high-quality clinical practice guidelines in primary care.MethodsChinese and English databases and guideline websites were systematically searched for clinical practice guidelines in primary care published from January 1, 2019 to December 31, 2021, with additional searches conducted by reference tracing and Google Scholar. After screening was completed, basic information on included studies and information related to the development methodology was extracted and analyzed.ResultsTwenty primary guidelines published between 2019 and 2021 were finally included, 95% of which originated from developed countries. The most common developing institutions were universities/research institutes (8, 40%), the disciplines with the most attention were nursing (4, 20%), infectious diseases (3, 15%), and gastroenterology (3, 15%), and the areas of the guidelines were mainly focused on management (4, 20%), treatment (4, 20%) and nursing (3, 15%).None of the guidelines were registered, and 11 (55%) guidelines used evidence grading and strength of recommendation criteria. Mean reporting on the 18 topics in the Guideline 2.0 inventory was 40%, with relatively good reporting on the topics of guideline panelists (85%), conflict of interest considerations (75%), and evidence retrieval and incorporation (75%), and low reporting on the topics of organizing-budgeting-planning-training (15%), and summarizing the evidence and considering other information (15%).ConclusionsThe number of clinical practice guidelines in primary care that explicitly report on the methodology and process of development is low, and there is insufficient consideration of the relevant topics in the Guideline 2.0 checklist. It is recommended that future research focus on standardizing the reporting of clinical practice guidelines in primary care and developing the methodological guidebook for guideline development.