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.

Background: Complementary and alternative therapy is widely used to treat chronic obstructive pulmonary disease (COPD). A Chinese herbal medicine, JianPiYiFei (JPYF) II granules, have been shown to improve COPD patients' quality of life, however long-term effectiveness has not been examined. Purpose: To investigate whether long-term treatment with JPYF II granules is effective and safe for patients with stable, moderate to very severe COPD. Study design and methods: A multicentre, randomised, double-blinded, placebo-controlled trial was conducted. Eligible participants from six hospitals were randomly assigned 1:1 to receive either JPYF II granules or placebo for 52 weeks. The primary outcome was the change in St. George's Respiratory Questionnaire (SGRQ) score during treatment. Secondary outcomes included the frequency of acute exacerbations during treatment, COPD Assessment Test (CAT), 6-minute walking test (6MWT), lung function, body mass index, airflow obstruction, dyspnoea, exercise capacity (BODE) index, and peripheral capillary oxygen saturation (SpO2) at the end of treatment. Results: A total of 276 patients (138 in each group) were included in the analysis. JPYF II granules led to a significantly greater reduction in SGRQ score (-7.33 points, 95% CI -10.59 to -4.07; p < 0.0001) which reflects improved quality of life. JPYF II granules improved CAT (-3.49 points, 95% CI -5.12 to -1.86; p < 0.0001) and 6MWT (45.61 metres, 95% CI 20.26 to 70.95; p = 0.0005), compared with placebo. Acute exacerbations were less frequent with JPYF II granules than with placebo (0.87 vs. 1.34 events per patient; p = 0.0043). There were no significant differences between the groups in lung function, BODE index and SpO2. JPYF II granules were well tolerated and no significant adverse effects were noted. Conclusions: Long-term treatment with JPYF II granules is effective in moderate to very severe COPD, improving quality of life and exercise capacity, decreasing the risk of acute exacerbation, and relieving symptoms.

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.

Ulcerative colitis (UC), a chronic and nonspecific inflammatory disease of the intestine, has become a prevalent global health concern. This guideline aims to equip clinicians and caregivers with effective strategies for the treatment and management of adult UC patients using traditional Chinese medicine (TCM). The guideline systematically evaluated contemporary evidence through the Grading of Recommendations Assessment, Development, and Evaluation framework. Additionally, it incorporated insights from ancient Chinese medical sources, employing the evidence grading method found in traditional TCM literature. The development process involved collaboration with multidisciplinary experts and included input from patients with UC. The guideline, based on a comprehensive review of available evidence, present 40 recommendations. They offer a condensed overview of TCM's role in understanding the pathogenesis, diagnosis, and treatment of UC, along with an assessment of the efficacy of various TCM-based treatments. TCM exhibits promising outcomes in the treatment of UC. However, to establish its efficacy conclusively, further high-quality clinical studies on TCM for UC are essential.

BackgroundAn increasing number of systematic reviews (SRs) in the environmental field have been published in recent years as a result of the global concern about the health impacts of air pollution and temperature. However, no study has assessed and compared the methodological and reporting quality of SRs on the health effects of air pollutants and extreme temperatures. This study aims to assess and compare the methodological and reporting quality of SRs on the health effects of ambient air pollutants and extreme temperatures.MethodsPubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Library, Web of Science, and Epistemonikos databases were searched. Two researchers screened the literature and extracted information independently. The methodological quality of the SRs was assessed through A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2). The reporting quality was assessed through Preferred Reporting Items of Systematic reviews and Meta-Analyses (PRISMA).ResultsWe identified 405 SRs (286 for air pollution, 108 for temperature, and 11 for the synergistic effects). The methodological and reporting quality of the included SRs were suboptimal, with major deficiencies in protocol registration. The methodological quality of SRs of air pollutants was better than that of temperature, especially in terms of satisfactory explanations for any heterogeneity (69.6% v. 45.4%). The reporting quality of SRs of air pollution was better than temperature, however, adherence to the reporting of the assessment results of risk of bias in all SRs (53.5% v. 34.3%) was inadequate.ConclusionsMethodological and reporting quality of SRs on the health effect of air pollutants were higher than those of temperatures. However, deficiencies in protocol registration and the assessment of risk of bias remain an issue for both pollutants and temperatures. In addition, developing a risk-of-bias assessment tool applicable to the temperature field may improve the quality of SRs.

Objectives: To systematically analyze the use of evidence assessment tools in systematic reviews of management and education. Study design and setting: We systematically searched selected literature databases and websites to identify systematic reviews on management and education. We extracted general information of the included studies and information about the evidence assessment tool they applied, including whether it was used for methodological quality assessment, reporting quality assessment or evidence grading, as well as the name, reference, publication year, version and original intended use of the tool, the role of the tool in the systematic review, and whether the quality determination criteria were given. Results: A total of 299 systematic reviews were included, of which only 34.8% used evidence assessment tools. A total of 66 different evidence assessment tools were used, of which Risk of Bias (ROB) and its updated version (n = 16, 15.4%) were the most frequent. The specific roles of the evidence assessment tools were reported clearly in 57 reviews, and 27 reviews used two tools. Conclusion: Evidence assessment tools were seldom used in systematic reviews in social sciences. The understanding and reporting of evidence assessment tools among the researchers and users still needs improvement.

Background and Objectives: To review the efforts and progress in promoting quality and transparency of health research in China and to discuss how to improve.Methods: We focused on three different types of health research: clinical trials, systematic reviews, and clinical practice guidelines, and summarized China's progress from their registration, implementation, and reporting stages.Results: In the last 3 decades, China's major works include the following: 1) For registration, the trials and CPGs registries have been set up, and released policies to mandate registration and submission of protocols for trials. 2) For implementation, multiple clinical research and EBM centers have been established. The ResMan platform for data management has been created and required researchers to share results data. 3) For reporting, the Chinese EQUATOR Center has been set up. Translations and extensions of the CONSORT, PRISMA, and RIGHT have been published. 4) For traditional Chinese medicine (TCM), specific guidelines for the registration and reporting of TCM research have been developed.Conclusion: China has made progress in promoting research quality and transparency, especially in research registration and reporting. Nevertheless, more can be done in data management and sharing for research implementation, and good publication practices in TCM.(c) 2022 Elsevier Inc. All rights reserved.

Objective: Clinical Practice Guidelines (CPGs) have an indispensable role in guiding the selection of various treatments for insomnia, however, little is known about the quality of released insomnia CPGs. This study aims to critically appraise the quality of existing insomnia CPGs and identify quality limitations. Methods: PubMed, Web of Science, Embase, China National Knowledge Infrastructure, Wanfang, China Biology Medicine disc, and 6 databases of international guideline developing institutions were systematically searched. CPGs on the diagnosis or treatment of insomnia were included. Reviewers independently extracted basic information and development methods, and assessed methodological quality and reporting quality using the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool and Reporting Items for practice Guidelines in Healthcare (RIGHT) checklist respectively. Intraclass correlation coefficients (ICCs) were used to measure the agreement among reviewers and assess inter-rater reliability. Results: Twenty-six CPGs were identified that focused on adults, children, or children with autistic spectrum disorder, patients in the intensive care unit, patients with cancer and pregnant, lactating or menopausal women. Twenty-two CPGs used nine grading systems to rate the level of evidence and strength of recommendation. 53.85% CPGs were classified as "recommended with modification" according to the AGREE II scores (ICC from 0.64 to 0.90), and 2 CPGs were "recommended". The "clarity of presentation" domain achieved the highest mean score (67.9% +/- 11.04%) but the "applicability" domain (37.1% +/- 12.67%) achieved the lowest. The average reporting rate of RIGHT items in all guidelines was 67.87%. Conclusions: The quality of guidelines varied substantially. Guideline developers should realize the importance of guideline applicability, patients' preferences and values. (c) 2022 Elsevier B.V. All rights reserved.

Background As systematically developed statements regarding possible courses of action, health system guidance (HSG) can assist with making decisions about addressing problems or achieving goals in health systems. However, there are conceptual and methodological challenges in HSG implementation due to the complexity of health-system policy-making, the diversity of available evidence and vast differences in contexts. To address these gaps, we aim to develop a theoretical framework for supporting HSG implementation as part of a broader effort to promote evidence-informed policy-making in health systems. Methods To develop a theoretical framework about facilitators, barriers and strategies for HSG implementation, we will apply a critical interpretive synthesis (CIS) approach to synthesize the findings from a range of relevant literature. We will search 11 electronic databases and seven organizational websites to identify relevant published and grey literature. We will check the references of included studies and contact experts to identify additional eligible papers. Finally, we will conduct purposively sampling of the literature to fill any identified conceptual gaps. We will use relevance and five quality criteria to assess included papers. A standardized form will be developed for extracting information. We will use an interpretive analytic approach to synthesize the findings, including a constant comparative method throughout the analysis. Two independent reviewers will conduct the literature screening and relevance assessment, and disagreements will be resolved through discussion. The principal investigator will conduct data extraction and synthesis, and a second reviewer will check the sample of extracted data for consistency and accuracy. Discussion A new theoretical framework about facilitators, barriers and strategies for HSG implementation will be developed using a CIS approach. The HSG implementation framework could be widely used for supporting the implementation of HSG covering varied topics and in different contexts (including low-, middle- and high-income countries). In later work, we will develop a tool for supporting HSG implementation based on the theoretical framework. Registration PROSPERO CRD42020214072. Date of Registration: 14 December 2020.

To explore the current state of research on off-label drug use in children and identify the existing research gaps in this topic. Six literature databases were searched to identify studies focusing exclusively on off-label drug use in children (aged < 18 years) published in Chinese or English between 2016 and 2021. We also searched clinicaltrials.gov for pediatric clinical trials conducted in the same period and compared the numbers of studies on off-label use and clinical trials for the most commonly reported drugs and drug types. Our search revealed 568 studies on off-label drug use. Almost half of the studies (n = 240) were cross-sectional. A total of 212 specific drugs or drug types were addressed in 361 studies, the most frequent being antipsychotic agents (n = 12), dexmedetomidine (n = 10), and rituximab (n = 8). Antipsychotic agents were also the most common type of drug examined in clinical trials in children. We identified a total of 435 different types of off-label use, the top three being unapproved indication (n = 157), population (n = 96), or age (n = 36). Only about one-third of the studies reported collecting informed consent (n = 195) or having ethics committee approval (n = 166). Conclusions: Off-label use of antipsychotics in children is widely reported in the literature. We suggest pediatric researchers to consider the number of studies on off-label use and existing clinical trials on different drugs when selecting target drugs for new studies and systematic reviews. What is Known: center dot There exist a large number of studies on off-label drug use in children. What is New: center dot This is the first scoping review of studies on off-label drug use in children. center dot Off-label use of antipsychotic agents is widely reported.