Search

Expert evidence, expert opinion, and expert consensus are frequently mentioned and used in the process of guideline development. However, due to the lack of clear definitions and standards, there is confusion and misuse among the three in practice. This paper clarifies the meanings, current status, differences, and connections of expert evidence, expert opinion, and expert consensus in the development of guidelines, aiming to provide a reference for guideline developers in China.

The essence of clinical practice guidelines lies in their recommendations. It is common to find strong recommendations supported by low-quality evidence in current published guidelines. There is a typical misunderstanding among medical professionals that without high-quality evidence, it is impossible to develop high-quality guidelines or only expert consensus can be developed. Based on the GRADE approach, this paper explains the concept and clinical significance of low-quality evidence, and introduces the methods for formulating recommendations based on low-quality evidence in guidelines, with the aim to provide reference for guideline developers and users in China.

National health standards involve all kinds of technical requirements formulated and numbered in accordance with the procedures and formats stipulated in the standardisation system for the implementation of national health and hygiene laws, regulations and policies, and the protection of human health. The establishment of health standards in China should align with our legal framework, including laws, regulations, departmental rules, and health and hygiene policies. During the development of these standards, a comprehensive approach is advocated, encompassing in-depth investigations, rigorous demonstrations, and extensive stakeholder engagement. However, the process of standard formulation may suffer from insufficient research evidence. The evidence-based concept emphasizes the significance of evidence. Therefore, integrating evidence-based concept into the process of developing health standards can enhance the quality and scientific basis of these standards. This article systematically elucidates the current status and development process of health standards in China, explores the necessity and feasibility of incorporating evidence-based concept into the development of these standards, analyzes the challenges and opportunities, and presents reflections and suggestions.

With the development of the Scientific, Transparent and Applicable Rankings tool for clinical practice guidelines(STAR), the publication of evaluation and ranking for scientificity, transparency and applicability of Chinese guidelines and consensus published in the medical journals in 2021and 2022, as well as the publication of the STAR evaluation and ranking for some specialities, the STAR evaluation and ranking has received widespread attention in the medical community. In order to further enhance its scientificity and transparency, Methodology and Technology Specialization Committee of the STAR Working Group presents this article to introduce sample identification and speciality assignment in the evaluation and ranking process.

The aims of developing rapid and living guidelines is to keep the recommendations in the guideline up-to-date. Compared with the conventional guideline, the rapid and living guideline can make better use of the existing evidence and apply and transform the evidence in a timely manner. This paper introduces the advantages and usage of rapid and living guidelines, the development process and existing challenges, and offers some insights, in order to provide reference for domestic organizations and scholars engaged in guideline development.

Objective To analyze the current status of the development of adaptation guidelines in China, as well as their methodological quality and the reporting quality, in order to provide reference for the development of adaptation guidelines. Methods We searched and collected adaptation guidelines led by Chinese researchers or institutions from 2015 to 2023 from four electronic databases, China National Knowledge Infrastructure, WanFang Data Knowledge Service Platform, SinoMed and PubMed, extracted the basic information of the adapted guidelines, and assessed their methodological quality and reporting quality using the Appraisal of Guidelines for REsearch and Evaluation (AGREE) Ⅱ and RIGHT-Ad@pt tools. Results A total of 14 adaptation guidelines were included, mainly focusing on nursing (42.9%, 6/14), with the most frequently used adaptation method of ADAPTE (71.4%, 10/14), and with reference to pre-existing guidelines mainly from the United States, the United Kingdom, and international organizations. Assessment by the AGREE Ⅱ tool showed that the average methodological quality score of the adapted guidelines was 36.6%. The scores were relatively high in the domains of clarity of expression and rigor of formulation (44.4% and 54.9%), and lowest in the domain of applicability (15.3%). The results of the RIGHT-Ad@pt tool showed that the reporting quality of the adaptation guidelines was relatively good, with the highest reporting rate of 91.2% and the lowest of 35.3%, and the reporting rates of seven articles were higher than 70%. Conclusions Adaptation guidelines in China are still in their infancy, with a relatively small number and mainly focusing on the nursing field. The most commonly used adaptation method is the ADAPTE method. The methodological quality and reporting quality of adaptation guidelines need to be further improved, and more research should be conducted on the specific conditions and timing of adaptation guidelines development.

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.

Objective To 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. Methods Chinese 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. Results Twenty 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%). Conclusions The 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.

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.

Evidence synthesis is the synthesis of existing research using a systematic and appropriate method. Various types of evidence synthesis are currently in use. Correctly choosing and applying the best evidence synthesis method is crucial for researchers, policymakers, and stakeholders. Thus, based on summarizing the current situation, progress, and classification of evidence synthesis methods, we introduced the definition and characteristics of common evidence synthesis methods and problems in their application, and presented thoughts and suggestions for the problems in the application of evidence synthesis methods.

Patient and public versions of guidelines (PVG) have attracted increasing attention in China, and their number is also on the rise. This article explores the methods for the development of PVG, introduces and compares different development methods, and incorporates case studies for interpretation, with the aim of providing reference for the developers of PVG and further promoting the development of PVG in China.

The quality and methodology of guidelines developed by the World Health Organization (WHO) have been continuously improved after decades of development and reform. However, the implementation of conventional guidelines faces certain challenges, including lengthy timelines, the possible loss of accuracy and consistency of recommendations, and limited capacity of some countries to support guideline adaptation and implement. As a result, the expected effects of guideline recommendations may not be fully achieved. As many countries are investing heavily in digital health systems, both the WHO and its Member States have recognized the importance of digital implementation of guidelines and developed the SMART Guidelines. As a new approach, SMART Guidelines can accelerate the implementation of evidence-based recommendations in the digital age, enhance their compliance and implementability, and improve healthcare quality and population outcomes. This article aims to provide an overview of the background, definition, framework, and knowledge layers of the WHO SMART Guidelines, using antenatal care guidelines as an example for interpretation.

Background Clinical practice guidelines in primary care are important tools to guide primary care practice, but they are found with relatively low quality and unstandardized reporting on the whole. Objective To develop the reporting guideline for clinical practice guidelines in primary care based on the Reporting Items for practice Guidelines in HealThcare (RIGHT) . Methods According to the reporting methods recommended by EQUATOR Network, an item development group and an expert consensus group were established to develop reporting guideline for clinical practice guidelines in primary care. Content analysis, brainstorming, and topic analysis were used in developing the initial items. The Delphi survey was conducted to determine the final items. Results Thirteen items (five were modified and eight were added) were developed initially, covering five domains: guideline title, health issues, intended setting, recommendations and suggestions for future research. Then the initial item checklist was revised to a final version consisting of 15 items according to the results of two rounds of Delphi survey (with 100% response rates from 22 experts) conducted from December 2 to December 26, 2022. Conclusion This reporting checklist will provide a detailed guide for developers of guidelines in primary care, which will further improve the reporting quality of guidelines in primary care, especially that of those in China.

Background The clinical practice guidelines in general practice can improve healthcare quality in primary health care, however, no study has yet systematically investigated the current status and quality of the guidelines in China. Objective To investigate the current status and influencing factors of quality of the guidelines in China. Methods We searched China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform, Chinese biomedical literature database, and CQVIP website, and included the published guidelines in China. We analyzed the basic characteristics and used RIGHT to evaluate the reporting quality and AGREE-China for methodological quality. Results A total of 150 guidelines were included, mainly published from 2019 to 2021. Most of the guidelines〔108 (72.0%) 〕focused on the diagnosis and treatment of diseases. The top three specialties were cardiovascular disease〔40 (26.7%) 〕, gastroenterology〔31 (20.7%) 〕, and clinical pharmacy〔27 (18.0%) 〕. The main development institutions were the Chinese Medical Association and its branches〔123 (82.0%) 〕, the editorial committee of the Chinese Journal of General Practitioners〔119 (79.3%) 〕, and the Chinese Medical Journals Publishing House〔116 (77.3%) 〕. In terms of reporting quality, the average reporting rate of RIGHT was 23.6% (11.4%-42.9%) ; the reporting rate of basic information (59.8%) was higher, and that of evidence (0.3%) was the lowest. As for methodological quality, the average AGREE-China score was 23.4 (12.0-40.0) ; the reporting rates of conflicts of interest (63.0%) and availability/feasibility (53.0%) were higher, and that of economics (7.0%) was the lowest. Conclusion The number of Chinese clinical practice guidelines in general practice has increased rapidly in the past five years, which has played an important role in promoting the quality of primary health care. In the future, it is necessary to further develop the guidelines in different specialties and diseases and accelerate the methodology of development and reporting of the guidelines.

Although the incidence of rare diseases is extremely low, 6% to 8% of the global population are affected by more than 7000 rare diseases. Rare diseases guidelines are playing an increasingly important role as guiding documents in improving the health outcomes of patients with rare diseases. Therefore, we aim to systematically elaborate on the status quo, challenges and opportunities of rare disease guidelines at home and abroad, and put forward thoughts and suggestions on promoting the development of rare diseases guidelines in the future.

Objective To evaluate the methodological quality of systematic review/meta analysis (SR/MA) published in Chinese Science Citation Database (CSCD) journals in 2020, with the aim of providing suggestions for researchers in China to develop SR/MA and reference for editors and reviewers to review SR/MA. Methods The list of journals was formed with a sample of journals published by the Chinese Medical Association Publishing House and included in CSCD. Four researchers working in pairs conducted independently manual searches on the official websites of the journals to include SR/MA published in 2020, and one researcher conducted a supplementary search on China National Knowledge Infrastructure. After identifying the included literature, the researchers worked in pairs to extract information independently, evaluated methodological quality by using AMSTAR 2(A Measurement Tool to Assess Systematic Reviews 2) and performed statistical analysis of the results. Results A total of 79 journals from the Chinese Medical Association Publishing House were included in CSCD, 46 of which published SR/MA in 2020, and 126 SR/MA were included for analysis after screening according to inclusion and exclusion criteria. AMSTAR 2 evaluation results showed that the average score of SR/MA was 10.38±1.91. The scored proportion of 9 items was more than 70%. SR/MA met partially/met a minimum of 5 AMSTAR 2 items and a maximum of 12 items. Before the key items were adjusted, over 90% of SR/MA's credibility rating was critically low. After adjusting the key items according to the actual Chinese situation, about 40% of SR/MA's credibility rating was medium and low, respectively. The results of the stratified analysis showed that the use of GRADE, adherence to the PRISMA statement, the number of authors greater than 5, the language of publication, the type of included studies including RCTs, and the reporting of funding were not factors that influenced the methodological quality of SR/MA. Conclusions The methodological quality of SR/MA published in CSCD journals in 2020 need to improve. Attention should be paid to the registration, retrieval, inclusion and exclusion criteria of SR/MA as well as financial support, so as to effectively improve the quality of SR/MA.

Objective To compare and analyze the recommendations for the timing and frequency of home blood pressure monitoring (HBPM) in clinical practice guidelines to help clinicians select the best recommendations and provide suggestions for the development of recommendations in the future. Methods Clinical practice guidelines related to hypertension published in the last five years were systematically searched and screened, and the recommendations for the timing and frequency of HBPM were extracted for statistical analysis. Results A total of 21 guidelines developed by institutions in 16 countries or regions were included, containing recommendations related to the timing and/or frequency of HBPM. For the HBPM timing, all guidelines recommend that blood pressure measurements be taken twice a day, in the morning and evening. In the morning blood pressure should be measured before taking antihypertensive medication (94.4%, 17/18), before breakfast (72.2%, 13/18) and after urination (55.6%, 10/18), while in the evening it should be taken before dinner (50.0%, 8/16), before bedtime (37.5%, 6/16) or 2 hours after dinner (6.3%, 1/16).For HBPM frequency, 9 (40.9%, 9/22) guidelines recommend at least 3 consecutive days of measurement in the week before the visit, and others suggest that measurements should be taken consecutively for at least 4 d (18.2%, 4/22), 5 d (13.6%, 3/22) or 7 d (27.3%, 6/22) days. Conclusions The guidelines of different countries and regions have great differences in recommendations on the timing and frequency of HBPM. It is recommended that future guideline developers develop the best recommendations after a thorough search, evaluation, and synthesis of the evidence, with full consideration of the balance of pros and cons, feasibility, patient preferences and values, as well as the context in which the guidelines are implemented.

A comprehensive evaluation of clinical practice guidelines (CPGs) is essential to measure their quality. This study introduces the function and meaning of the systematic review of CPGs and combs the development and current status of guideline appraisal tools. On this basis, we expound the content and characteristics of the Scientific, Transparent, and Applicable Rankings Tool (STAR) for Guidelines in depth, with the hope of providing reference for the improvement of the compressive guideline assessment system and the development of high-quality guidelines in the future.

This study reviews the core methods and models that have emerged from the development of evidence-based medicine over the past 30 years, including the PICO question model, systematic reviews, grading of evidence quality and strength of recommendations, reporting guidelines, the 5S pyramid of evidence resources, and evidence ecosystem. The above methods and models constitute the theoretical system, promote the progress of evidence-based medicine and provide the internal impetus for its development. The clarification of the core methods and key models of evidence-based medicine will help scholars and researchers fully understand its scientific philosophy, explore its future direction in light of current development trends, achieve its renewal and iteration, and further promote the construction of evidence-based science and the development of multidisciplinary integration.

As an important guidance of medical practice, clinical practice guideline of integrative Chinese medicine (ICM-CPG) plays an extremely important role in showing the respective advantages of Chinese and Western medicine and in promoting the integrated Chinese and Western medicine. However, the research status on ICM-CPG is faced with the problem of emphasizing development but neglecting implementation. The establishment of ICM-CPG implementation model based on the theoretical framework of implementation science is conducive to promoting the implementation of ICM-CPG and advancing the integration and development of Chinese and Western medicine. In this paper, by sorting out and analyzing the knowledge to action (KTA) framework, we discuss the implementation framework development of ICM-CPG in order to provide reference for future research.

Off-label drug use represents a reasonable need for diagnosis and treatment in some cases, but it faces potential risks with drug safety and legal challenges. However, there was no guideline on how to manage the off-label drug use in China. Therefore, Peking Union Medical College Hospital, in cooperation with Evidence-based Medicine Center of Lanzhou University, established a working group and an expert group consisting of multidisciplinary group of experts to develop the Management Guideline for the Off-label Use of Drugs in China (2021). The Guideline is guided by the Law on Doctors of the People's Republic of China and the World Health Organization Guideline Development Manual. This is the first management guideline on the off-label use of drugs, aiming to improve the stakeholders' understanding of this topic and establish a standardized management procedure in China. This guideline has determined nine questions and proposed a total of twenty-three recommendations. The English version of the guideline was published in September 2022. This paper offers a detailed interpretation of the key points of the guidelines in order to provide suggestions and references for the management of off-label drug use.

The registration of the guidelines is not only the initial step in the development process, but also an important part of the quality control of the guidelines. Thus, we analyzed the establishment and evolution of registration systems, the current state of guideline registration platforms, and the use of the Practice guideline REgistration for transPAREncy(PREPARE), with the goal of improving the transparency and quality of guideline development.

Clinical practice guidelines can facilitate the standardization of the diagnosis and treatment and improve health care quality. However, there are barriers to guideline dissemination and implementation, thus impeding the standardization of clinical practice and improvement of patient outcomes. One major barrier is that it is difficult for doctors to read and understand the unstructured text-based guidelines, and apply them in real clinical practice. This paper introduces the design of decision trees based on clinical practice guidelines, and the advantages, challenges and solutions of this approach, with the hope of providing references for promoting the transformation of textual clinical practice guidelines.