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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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The reporting quality of N-of-1 trials and protocols still needs improvement
Objective To evaluate the reporting quality of single-patient (N-of-1) trials and protocols based on the CONSORT Extension for N-of-1 trials (CENT) statement and the standard protocol items: recommendations for interventional trials (SPIRIT) extension and elaboration for N-of-1 trials (SPENT) checklist to examine the factors that influenced reporting quality. Methods Four electronic databases were searched to identify N-of-1 trials and protocols from 2015 to 2020. Quality was assessed by two reviewers. We calculated the overall scores based on binary responses in which "Yes" was scored as 1 (if the item was fully reported), and "No" was scored as 0 (if the item was not clearly reported or not definitely stated). Results A total of 78 publications (55 N-of-1 trials and 23 protocols) were identified. The mean reporting score (SD) of the N-of-1 trials and protocols were 29.24 (0.89) and 29.61 (1.83), respectively. For the items related to outcomes, sample size, allocation concealment protocol, and informed consent materials, the reporting quality was low. Our results showed that the year of publication (t = -0.793, p = 0.872 for the trials and t = 1.352, p = 0.623 for the protocols) and the impact factor of the journal (t = 1.416, p = 0.619 for the trials and t = 0.359, p = 0.667 for the protocols) were not factors associated with better reporting quality. Conclusion With the publication of the CENT 2015 statement and the SPENT 2019 checklist, authors should adhere to the relevant reporting guidelines and improve the reporting quality of N-of-1 trials and protocols.
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Achieving higher performing primary care through patient registration: A review of twelve high-income countries
Background Patient registration with a primary care providers supports continuity in the patient-provider relationship. This paper develops a framework for analysing the characteristics of patient registration across countries; applies this framework to a selection of countries; and identifies challenges and ongoing reform efforts. Methods 12 jurisdictions (Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Norway, Ontario [Canada], Sweden, Switzerland, United Kingdom) were selected for analysis. Information was collected by national researchers who reviewed relevant literature and policy documents to report on the establishment and evolution of patient registration, the requirements and benefits for patients, providers and payers, and its connection to primary care reforms. Results Patient registration emerged as part of major macro-level health reforms linked to the introduction of universal health coverage. Recent reforms introduced registration with the aim of improving quality through better coordination and efficiency through reductions in unnecessary referrals. Patient registration is mandatory only in three countries. Several countries achieve high levels of registration by using strong incentives for patients and physicians (capitation payments). Conclusion Patient registration means different things in different countries and policy-makers and researchers need to take into consideration: the history and characteristics of the registration system; the use of incentives for patients and providers; and the potential for more explicit use of patient-provider agreements as a policy to achieve more timely, appropriate, continuous and integrated care.
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Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS
ObjectiveTo assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS.MethodWe searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes.ResultsA total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s).ConclusionOverall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.
期刊论文
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Registration factors that limit international mobility of people holding physiotherapy qualifications: A systematic review
Introduction There is no enforced international standardisation of the physiotherapy profession. Thus, registration is used in many countries to maintain standards of care and to protect the public. However, registration may also limit international workforce mobility. Question What is known about the professional registration factors that may limit the international mobility of people holding physiotherapy qualifications? Design Systematic review using an electronic database search and hand searching of the World Confederation for Physical Therapy and International Network of Physiotherapy Regulatory Authorities websites. Analysis was conducted using thematic analysis. Results 10 articles and eight websites were included from the search strategy. Data is representative of high-income English speaking countries. Four themes emerged regarding limitations to professional mobility: practice context, qualification recognition, verification of fitness to practice, and incidental limitations arising from the registration process. Conclusion Professional mobility is limited by differences in physiotherapy education programmes, resulting in varying standards of competency. Thus, it is often necessary to verify clinical competencies through assessments, as well as determining professional attributes and ability to apply competencies in a different practice context, as part of the registration process. There has been little evaluation of registration practices, and at present, there is a need to re-evaluate current registration processes to ensure they are efficient and effective, thereby enhancing workforce mobility.
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