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Promoting the quality and transparency of health research in China
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.
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Guideline for the diagnosis, treatment and long-term management of cutaneous lupus erythematosus
Cutaneous lupus erythematosus (CLE) is an inflammatory, autoimmune disease encompassing a broad spectrum of subtypes including acute, subacute, chronic and intermittent CLE. Among these, chronic CLE can be further classified into several subclasses of lupus erythematosus (LE) such as discoid LE, verrucous LE, LE profundus, chilblain LE and Blaschko linear LE. To provide all dermatologists and rheumatologists with a practical guideline for the diagnosis, treatment and long-term management of CLE, this evidence- and consensus-based guideline was developed following the checklist established by the international Reporting Items for Practice Guidelines in Healthcare (RIGHT) Working Group and was registered at the International Practice Guideline Registry Platform. With the joint efforts of the Asian Dermatological Association (ADA), the Asian Academy of Dermatology and Venereology (AADV) and the Lupus Erythematosus Research Center of Chinese Society of Dermatology (CSD), a total of 25 dermatologists, 7 rheumatologists, one research scientist on lupus and 2 methodologists, from 16 countries/regions in Asia, America and Europe, participated in the development of this guideline. All recommendations were agreed on by at least 80% of the 32 voting physicians. As a consensus, diagnosis of CLE is mainly based on the evaluation of clinical and histopathological manifestations, with an exclusion of SLE by assessment of systemic involvement. For localized CLE lesions, topical corticosteroids and topical calcineurin inhibitors are first-line treatment. For widespread or severe CLE lesions and (or) cases resistant to topical treatment, systemic treatment including antimalarials and (or) short-term corticosteroids can be added. Notably, antimalarials are the first-line systemic treatment for all types of CLE, and can also be used in pregnant patients and pediatric patients. Second-line choices include thalidomide, retinoids, dapsone and MTX, whereas MMF is third-line treatment. Finally, pulsed-dye laser or surgery can be added as fourth-line treatment for localized, refractory lesions of CCLE in cosmetically unacceptable areas, whereas belimumab may be used as fourth-line treatment for widespread CLE lesions in patients with active SLE, or recurrence of ACLE during tapering of corticosteroids. As for management of the disease, patient education and a long-term follow-up are necessary. Disease activity, damage of skin and other organs, quality of life, comorbidities and possible adverse events are suggested to be assessed in every follow-up visit, when appropriate.
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PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Extension for Chinese Herbal Medicines 2020 (PRISMA-CHM 2020)
Chinese Herbal Medicines (CHM) are the most common interventions of traditional Chinese medicine (TCM), typically administered as either single herbs or formulas. Systematic reviews (SRs) are essential references for evaluating the efficacy and safety of CHM treatments accurately and reliably. Unfortunately, the reporting quality of SRs with CHM is not optimal, especially the reporting of CHM interventions and the rationale of why these interventions were selected. To address this problem, a group of TCM clinical experts, methodologists, epidemiologists, and editors has developed a PRISMA extension for CHM interventions (PRISMA-CHM) through a comprehensive process, including registration, literature review, consensus meeting, three-round Delphi survey, and finalization. The PRISMA checklist was extended by introducing the concept of TCM Pattern and the characteristics of CHM interventions. A total of twenty-four items (including sub-items) are included in the checklist, relating to title (1), structured summary (2), rationale (3), objectives (4), eligibility criteria (6), data items (11), synthesis of results (14, 21), additional analyses (16, 23), study characteristics (18), summary of evidence (24), and conclusions (26). Illustrative examples and explanations are also provided. The group hopes that PRISMA-CHM 2020 will improve the reporting quality of SRs of CHM.
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