The characteristics, development methods, reporting quality, and evidence basis of diagnostic criteria in China between 1965 and 2023: A cross-sectional study.

OBJECTIVE: As 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. METHODS: We 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. RESULTS: A 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. CONCLUSION: The 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.

Mapping the awareness and knowledge about patient and public versions of guidelines among stakeholders in China: a cross-sectional survey.

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.

Reporting Conflicts of Interest and Funding in Health Care Guidelines: The RIGHT-COI&F Checklist.

BACKGROUND: Conflicts of interest (COIs) of contributors to a guideline project and the funding of that project can influence the development of the guideline. Comprehensive reporting of information on COIs and funding is essential for the transparency and credibility of guidelines. OBJECTIVE: To develop an extension of the Reporting Items for practice Guidelines in HealThcare (RIGHT) statement for the reporting of COIs and funding in policy documents of guideline organizations and in guidelines: the RIGHT-COI&F checklist. DESIGN: The recommendations of the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network were followed. The process consisted of registration of the project and setting up working groups, generation of the initial list of items, achieving consensus on the items, and formulating and testing the final checklist. SETTING: International collaboration. PARTICIPANTS: 44 experts. MEASUREMENTS: Consensus on checklist items. RESULTS: The checklist contains 27 items: 18 about the COIs of contributors and 9 about the funding of the guideline project. Of the 27 items, 16 are labeled as policy related because they address the reporting of COI and funding policies that apply across an organization's guideline projects. These items should be described ideally in the organization's policy documents, otherwise in the specific guideline. The remaining 11 items are labeled as implementation related and they address the reporting of COIs and funding of the specific guideline. LIMITATION: The RIGHT-COI&F checklist requires testing in real-life use. CONCLUSION: The RIGHT-COI&F checklist can be used to guide the reporting of COIs and funding in guideline development and to assess the completeness of reporting in published guidelines and policy documents. PRIMARY FUNDING SOURCE: The Fundamental Research Funds for the Central Universities of China.

Potential Roles of Large Language Models in the Production of Systematic Reviews and Meta-Analyses.

Large language models (LLMs) such as ChatGPT have become widely applied in the field of medical research. In the process of conducting systematic reviews, similar tools can be used to expedite various steps, including defining clinical questions, performing the literature search, document screening, information extraction, and language refinement, thereby conserving resources and enhancing efficiency. However, when using LLMs, attention should be paid to transparent reporting, distinguishing between genuine and false content, and avoiding academic misconduct. In this viewpoint, we highlight the potential roles of LLMs in the creation of systematic reviews and meta-analyses, elucidating their advantages, limitations, and future research directions, aiming to provide insights and guidance for authors planning systematic reviews and meta-analyses.

Paediatric off-label use of drugs in Gansu, China: a multicentre cross-sectional study.

OBJECTIVE: To examine the current prevalence and cost of paediatric off-label drug prescriptions in Gansu, China, and the potential influencing factors. DESIGN: The prevalence of off-label prescriptions in paediatrics was evaluated according to the National Medical Products Administration drug instructions in the China Pharmaceutical Reference (China Pharmaceutical Reference, MCDEX) database. The evidence of the prescription was determined by existing clinical practice guidelines and the Thomson Grade in the Micromedex 2021 compendium. We used logistic regression to investigate the characteristics that influence paediatric off-label drug use after single-factor regression analysis. SETTING: A multicentre cross-sectional study of outpatient paediatric prescriptions in 196 secondary and tertiary hospitals in Gansu Province, China, in March and September 2020. RESULTS: We retrieved 104 029 paediatric prescriptions, of which 39 480 (38.0%) contained off-label use. The most common diseases treated by off-label drugs were respiratory system diseases (n=15 831, 40.1%). A quarter of off-label prescriptions had adequate evidence basis (n=10 130, 25.6%). Unapproved indications were the most common type of off-label drug use (n=25 891, 65.6%). A total of 1177 different drugs were prescribed off-label, with multienzyme tablets being the most common drug (n=1790, 3.5%). The total cost of the prescribed off-label drugs was ¥106 116/day. Off-label prescriptions were less frequent in tertiary than in secondary hospitals. Topical preparations were more commonly prescribed off-label than other types of drugs. Senior-level clinicians prescribed drugs off-label more often than intermediate and junior clinicians. CONCLUSION: Off-label drug use is widespread in paediatric practice in China. Three-quarters of the prescriptions may potentially include inappropriate medication use, resulting in a daily economic burden of about ¥81 000 in 2020 in Gansu Province with 25 million inhabitants. The management of off-label drug use in paediatrics in China needs improvement.

Patient and public involvement in systematic reviews: frequency, determinants, stages, barriers, and dissemination.

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.

Barriers and facilitators to guideline for the management of pediatric off-label use of drugs in China: a qualitative descriptive study.

BACKGROUND: Despite being a global public health concern, there is a research gap in analyzing implementation strategies for managing off-label drug use in children. This study aims to understand professional health managers' perspectives on implementing the Guideline in hospitals and determine the Guideline's implementation facilitators and barriers. METHODS: Pediatric directors, pharmacy directors, and medical department directors from secondary and tertiary hospitals across the country were recruited for online interviews. The interviews were performed between June 27 and August 25, 2022. The Consolidated Framework for Implementation Research (CFIR) was adopted for data collection, data analysis, and findings interpretation to implement interventions across healthcare settings. RESULTS: Individual interviews were conducted with 28 healthcare professionals from all over the Chinese mainland. Key stakeholders in implementing the Guideline for the Management of Pediatric Off-Label Use of Drugs in China (2021) were interviewed to identify 57 influencing factors, including 27 facilitators, 29 barriers, and one neutral factor, based on the CFIR framework. The study revealed the complexity of the factors influencing managing children's off-label medication use. A lack of policy incentives was the key obstacle in external settings. The communication barrier between pharmacists and physicians was the most critical internal barrier. CONCLUSION: To our knowledge, this study significantly reduces the implementation gap in managing children's off-label drug use. We provided a reference for the standardized management of children's off-label use of drugs.

Development of the China's list of ambulatory care sensitive conditions (ACSCs): a study protocol.

BACKGROUND: The hospitalization rate of ambulatory care sensitive conditions (ACSCs) has been recognized as an essential indicator reflective of the overall performance of healthcare system. At present, ACSCs has been widely used in practice and research to evaluate health service quality and efficiency worldwide. The definition of ACSCs varies across countries due to different challenges posed on healthcare systems. However, China does not have its own list of ACSCs. The study aims to develop a list to meet health system monitoring, reporting and evaluation needs in China. METHODS: To develop the list, we will combine the best methodological evidence available with real-world evidence, adopt a systematic and rigorous process and absorb multidisciplinary expertise. Specific steps include: (1) establishment of working groups; (2) generations of the initial list (review of already published lists, semi-structured interviews, calculations of hospitalization rate); (3) optimization of the list (evidence evaluation, Delphi consensus survey); and (4) approval of a final version of China's ACSCs list. Within each step of the process, we will calculate frequencies and proportions, use descriptive analysis to summarize and draw conclusions, discuss the results, draft a report, and refine the list. DISCUSSION: Once completed, China's list of ACSCs can be used to comprehensively evaluate the current situation and performance of health services, identify flaws and deficiencies embedded in the healthcare system to provide evidence-based implications to inform decision-makings towards the optimization of China's healthcare system. The experiences might be broadly applicable and serve the purpose of being a prime example for nations with similar conditions.

CARE-radiology statement explanation and elaboration: reporting guideline for radiological case reports.

Despite the increasing number of radiological case reports, the majority lack a standardised methodology of writing and reporting. We therefore develop a reporting guideline for radiological case reports based on the CAse REport (CARE) statement. We established a multidisciplinary group of experts, comprising 40 radiologists, methodologists, journal editors and researchers, to develop a reporting guideline for radiological case reports according to the methodology recommended by the Enhancing the QUAlity and Transparency Of health Research network. The Delphi panel was requested to evaluate the significance of a list of elements for potential inclusion in a guideline for reporting mediation analyses. By reviewing the reporting guidelines and through discussion, we initially drafted 46 potential items. Following a Delphi survey and discussion, the final CARE-radiology checklist is comprised of 38 items in 16 domains. CARE-radiology is a comprehensive reporting guideline for radiological case reports developed using a rigorous methodology. We hope that compliance with CARE-radiology will help in the future to improve the completeness and quality of case reports in radiology.

Reporting guidelines for traditional Chinese medicine could be improved: a cross-sectional study.

OBJECTIVES: The aim of this study is to identify available reporting guidelines for traditional Chinese medicine (TCM), delineate their fundamental characteristics, assess the scientific rigor of their development process, and evaluate their dissemination. STUDY DESIGN AND SETTING: A search was conducted in Medline (via PubMed), China National Knowledge Infrastructure (CNKI), SinoMed, WANFANG DATA, and the EQUATOR Network to identify TCM reporting guidelines. A preprepared Excel database was used to extract information on the basic characteristics, development process, and dissemination information. The development process quality of TCM reporting guidelines was assessed by evaluating their compliance with the Guidance for Developers of Health Research Reporting Guidelines (GDHRRG). The extent of dissemination of these guidelines was analyzed by examining the number of citations received. RESULTS: A total of 26 reporting guidelines for TCM were obtained from 20 academic journals, with 61.5% of them published in English journals. Among the guidelines, 14 (53.8%) were registered in the EQUATOR Network. On average, the compliance rate of GDHRRG guidelines was reported to be 63.3% ranging from 22.2% to 94.4%. Three steps showed poor compliance, namely guideline endorsement (23.1%), translated guidelines (19.2%), and developing a publication strategy (19.2%). Furthermore, the compliance rate of GDHRRG guidelines published in English journals was higher than that in Chinese journals. In terms of the dissemination, 15.4% of the guidelines had been cited over 100 times, while 73.1% had been cited less than 50 times. CONCLUSION: The development of TCM reporting guidelines still has limitations in terms of regarding scientific rigor and follow-up dissemination. Therefore, it is important to ensure adherence to the scientific process in the development of TCM reporting guidelines and to strengthen their promotion, dissemination, and implementation.

Exploring the diverse definitions of 'evidence': a scoping review.

OBJECTIVES: To systematically collect and analyse diverse definitions of 'evidence' in both health and social sciences, and help users to correctly use the term 'evidence' and rethink what is the definition of 'evidence' in scientific research. DESIGN: Scoping review. METHODS: Definitions of evidence in the health sciences and social sciences were included. We have excluded the definition of evidence applied in the legal field, abstracts without full text, documents not published in either Chinese or English and so on. We established a multidisciplinary working group and systematically searched five electronic databases including Medline, Web of Science, EBSCO, the Chinese Social Sciences Citation Index and the Chinese Science Citation Database from their inception to 26 February 2022. We also searched websites and reviewed the reference lists of the identified studies. Six reviewers working in pairs, independently, selected studies according to the inclusion and exclusion criteria, and extracted information. Any differences were discussed in pairs, and if there was disagreement, it was resolved via discussion or with the help of a third reviewer. Reviewers extracted document characteristics, the original content for the definitions of 'evidence', assessed definitions as either intensional or extensional, and any citations for the given definition. RESULTS: Forty-nine documents were finally included after screening, and 68 definitions were obtained. After excluding duplicates, a total of 54 different definitions of 'evidence' were identified. There were 42 intensional definitions and 12 extensional definitions. The top three definiens were 'information', 'fact' and 'research/study'. The definition of 'evidence' differed between health and social sciences. The term 'research' appeared most frequently in the definitions. CONCLUSIONS: The definition of 'evidence' has gradually attracted the attention of many scholars and decision-makers in health and social sciences. Nevertheless, there is no widely recognised and accepted definition in scientific research. Given the wide use of the term, we need to think about whether, or under what circumstances, a standardised, clear, meaningful and widely applicable definition of 'evidence' might be helpful.