scholarly journals Quality assessment of clinical trial registration with traditional Chinese medicine in WHO registries

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e025218 ◽  
Author(s):  
Xuan Zhang ◽  
Ran Tian ◽  
Zhen Yang ◽  
Chen Zhao ◽  
Liang Yao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Reporting Quality ◽  
Reporting Rate ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Data Set

ObjectiveThis study aimed to assess the registration quality of clinical trials (CTs) with traditional Chinese medicine (TCM) in the WHO International Clinical Trials Registry Platform (ICTRP) and identify the common problems if any.MethodsThe ICTRP database was searched for all TCM CTs that were registered up to 31 December 2017. Registered information of each trial was collected from specific registry involved in ICTRP through hyperlink. The primary analysis was to assess the reporting quality of registered trials with TCM interventions, which is based on the minimum 20 items of WHO Trial Registration Data Set (TRDS, V.1.2.1) plus optional additional three items recommended by ICTRP, and some specific items for TCM information (including TCM intervention, diagnosis, outcome and rationale). Descriptive statistics were additionally used to analyse the baseline characteristics of TCM trial registrations.ResultsA total of 3339 records in 15 registries were examined. The number of TCM registered trials has increased rapidly after the requirement of mandatory trial registration proposed by International Committee of Medical Journal Editors on 1 July 2005, and the top two registries were Chinese Clinical Trial Registry and ClincialTrials.gov. Of 3339 trials, 61% were prospective registration and 12.8% shared resultant publications. There were 2955 interventional trials but none of them had a 100% reporting rate of the minimum 20 items and additional three items. The reporting quality of these 23 items was not optimal due to 11 of them had a lower reporting rate (<65%). For TCM details, 49.2% lacked information on description of TCM intervention(s), 85.9% did not contain TCM diagnosis criteria, 92.6% did not use TCM outcome(s) and 67.1% lacked information on TCM background and rationale.ConclusionThe registration quality of TCM CTs should be improved by prospective registration, full completion of WHO TRDS, full reporting of TCM information and results sharing. Further full set of trial registration items for TCM trials should be developed thus to standardise the content of TCM trial registration.

scholarly journals 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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Secondary Outcome ◽  
Specific Information ◽  
Clinical Trial Registry ◽  
Data Set ◽  
Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We 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. Results A 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). Conclusion Overall, 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.

scholarly journals WHO Trial Registration Data Set (TRDS) Extension  for Traditional Chinese Medicine 2020: Recommendations, Explanation, and Elaboration

2020 ◽  
Author(s):  
Xuan Zhang ◽  
Liang Lan ◽  
Jacky CP Chan ◽  
Linda LD Zhong ◽  
Chung-Wah Cheng ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Reporting Quality ◽  
Health Condition ◽  
Trial Registration ◽  
Baseline Survey ◽  
Exclusion Criteria ◽  
Data Set ◽  
Registration Data

Abstract Background: Although the WHO Trial Registration Data Set (TRDS) has been published for many years, the quality of clinical trial registrations with traditional Chinese medicine (TCM) is still not satisfactory, especially about the inadequate reporting on TCM interventions. The development of the WHO TRDS for TCM Extension 2020 (WHO TRDS-TCM 2020) aims to address this inadequacy. Methods: A group of clinical experts, methodologists, epidemiologists, and editors has developed this WHO TRDS-TCM 2020 through a comprehensive process, including publication of the baseline survey, draft of the initial items, three-round of Delphi survey, solicitation of comments, revision, and finalization. Results: The WHO TRDS-TCM 2020 statement extends the latest version (V.1.3.1) of TRDS published in November 2017. The checklist includes 11 extended items (including subitems), namely Source(s) of Monetary or Material Support (Item 4), Scientific Title (Item 10a and 10b), Countries of Recruitment (Item 11), Health Condition(s) or Problem(s) Studied (Item 12), Intervention(s) (Item 13a, 13b and 13c), Key Inclusion and Exclusion Criteria (Item 14), Primary and Key Secondary Outcomes (Item 19 to 20), and Lay Summary (Item B1). For Item 13 (Interventions), three common TCM interventions--i.e., Chinese herbal medicine formulas, acupuncture and moxibustion—are elaborated. Conclusions: The group hopes that the WHO TRDS-TCM 2020 can improve the reporting quality and transparency of TCM trial registrations, assist registries in assessing the registration quality of TCM trials, and help readers understand TCM trial design.

scholarly journals WHO Trial Registration Data Set (TRDS) Extension  for Traditional Chinese Medicine 2020: Recommendations, Explanation, and Elaboration

2020 ◽  
Author(s):  
Xuan Zhang ◽  
Liang Lan ◽  
Jacky CP Chan ◽  
Linda LD Zhong ◽  
Chung-Wah Cheng ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Reporting Quality ◽  
Health Condition ◽  
Trial Registration ◽  
Baseline Survey ◽  
Exclusion Criteria ◽  
Data Set ◽  
Registration Data

Abstract Background: Although the WHO Trial Registration Data Set (TRDS) has been published for many years, the quality of clinical trial registrations with traditional Chinese medicine (TCM) is still not satisfactory, especially about the inadequate reporting on TCM interventions. The development of the WHO TRDS for TCM Extension 2020 (WHO TRDS-TCM 2020) aims to address this inadequacy. Methods: A group of clinical experts, methodologists, epidemiologists, and editors has developed this WHO TRDS-TCM 2020 through a comprehensive process, including the baseline survey, draft of the initial items, three-round of Delphi survey, solicitation of comments, revision, and finalization. Results: The WHO TRDS-TCM 2020 statement extends the latest version (V.1.3.1) of TRDS published in November 2017. The checklist includes 11 extended items (including subitems), namely Source(s) of Monetary or Material Support (Item 4), Scientific Title (Item 10a and 10b), Countries of Recruitment (Item 11), Health Condition(s) or Problem(s) Studied (Item 12), Intervention(s) (Item 13a, 13b and 13c), Key Inclusion and Exclusion Criteria (Item 14), Primary and Key Secondary Outcomes (Item 19 to 20), and Lay Summary (Item B1). For Item 13 (Interventions), three common TCM interventions--i.e., Chinese herbal medicine formulas, acupuncture and moxibustion—are elaborated. Conclusions: The group hopes that the WHO TRDS-TCM 2020 can improve the reporting quality and transparency of TCM trial registrations, assist registries in assessing the registration quality of TCM trials, and help readers understand TCM trial design.Trial registration: Not applicable.

scholarly journals WHO Trial Registration Data Set (TRDS) Extension  for Traditional Chinese Medicine 2020: Recommendations, Explanation, and Elaboration

2020 ◽  
Author(s):  
Xuan Zhang ◽  
Liang Lan ◽  
Jacky CP Chan ◽  
Linda LD Zhong ◽  
Chung-Wah Cheng ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Reporting Quality ◽  
Health Condition ◽  
Trial Registration ◽  
Baseline Survey ◽  
Exclusion Criteria ◽  
Data Set ◽  
Registration Data

Abstract Background: Although the WHO Trial Registration Data Set (TRDS) has been published for many years, the quality of clinical trial registrations with traditional Chinese medicine (TCM) is still not satisfactory, especially about the inadequate reporting on TCM interventions. The development of the WHO TRDS for TCM Extension 2020 (WHO TRDS-TCM 2020) aims to address this inadequacy. Methods: A group of clinical experts, methodologists, epidemiologists, and editors has developed this WHO TRDS-TCM 2020 through a comprehensive process, including the baseline survey, draft of the initial items, three-round of Delphi survey, solicitation of comments, revision, and finalization. Results: The WHO TRDS-TCM 2020 statement extends the latest version (V.1.3.1) of TRDS published in November 2017. The checklist includes 11 extended items (including subitems), namely Source(s) of Monetary or Material Support (Item 4), Scientific Title (Item 10a and 10b), Countries of Recruitment (Item 11), Health Condition(s) or Problem(s) Studied (Item 12), Intervention(s) (Item 13a, 13b and 13c), Key Inclusion and Exclusion Criteria (Item 14), Primary and Key Secondary Outcomes (Item 19 to 20), and Lay Summary (Item B1). For Item 13 (Interventions), three common TCM interventions--i.e., Chinese herbal medicine formulas, acupuncture and moxibustion—are elaborated. Conclusions: The group hopes that the WHO TRDS-TCM 2020 can improve the reporting quality and transparency of TCM trial registrations, assist registries in assessing the registration quality of TCM trials, and help readers understand TCM trial design.

scholarly journals WHO Trial Registration Data Set (TRDS) Extension  for Traditional Chinese Medicine 2020: Recommendations, Explanation, and Elaboration

2020 ◽  
Author(s):  
Xuan Zhang ◽  
Liang Lan ◽  
Jacky CP Chan ◽  
Linda LD Zhong ◽  
Chung-Wah Cheng ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Reporting Quality ◽  
Health Condition ◽  
Trial Registration ◽  
Exclusion Criteria ◽  
Data Set ◽  
Chinese Herbal ◽  
Registration Data

Abstract Background: Although the WHO Trial Registration Data Set (TRDS) has been published for many years, the quality of clinical trial registrations with traditional Chinese medicine (TCM) is still not satisfactory, especially about the inadequate reporting on TCM interventions. The development of the WHO TRDS for TCM Extension 2020 (WHO TRDS-TCM 2020) aims to address this inadequacy. Methods: A group of clinical experts, methodologists, epidemiologists, and editors has developed this WHO TRDS-TCM 2020 through a comprehensive process, including publication of the literature review, consensus collection of the initial items, three-round of Delphi survey, solicitation of comments, revision, and finalization. Results: The WHO TRDS-TCM 2020 statement extends the latest version (V.1.3.1) of TRDS published in November 2017. The checklist includes 11 extended items (including subitems), namely Source(s) of Monetary or Material Support (Item 4), Scientific Title (Item 10a and 10b), Countries of Recruitment (Item 11), Health Condition(s) or Problem(s) Studied (Item 12), Intervention(s) (Item 13a, 13b and 13c), Key Inclusion and Exclusion Criteria (Item 14), Primary and Key Secondary Outcomes (Item 19 to 20), and Lay Summary (Item B1). For Item 13 (Interventions), three common TCM interventions--i.e., Chinese herbal medicine formulas, acupuncture and moxibustion—are elaborated. Conclusions: The group hopes that the WHO TRDS-TCM 2020 can improve the reporting quality and transparency of TCM trial registrations, assist registries in assessing the registration quality of TCM trials, and help readers understand TCM trial design.

scholarly journals A scoping review of cohort studies assessing traditional Chinese medicine interventions

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Yuting Duan ◽  
Zhirui Xu ◽  
Jingjing Deng ◽  
Yanjia Lin ◽  
Yan Zheng ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Cohort Studies ◽  
Scoping Review ◽  
Chinese Literature ◽  
English Literature ◽  
Reporting Quality ◽  
Immune Deficiency Syndrome ◽  
Reporting Rate

Abstract Backgrounds Identifying topics and assessing the reporting quality of Traditional Chinese Medicine (TCM) cohort studies. Methods A scoping review of the literature was performed. A descriptive approach to summarize the core study characteristics was prepared, along with structured tables and figures to identify salient points of differences noted across studies. The reporting quality of TCM cohort studies was assessed according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)-cohort checklist. Results A total of 199 TCM cohort studies were included. The largest number of TCM cohort studies was conducted in Mainland China (70.9%). The TCM cohort study was first published in 2003. The top three diseases studied were Acquired Immune Deficiency Syndrome (AIDS), Stroke, and Asthma. As for the intervention methods, Chinese herbal medicine formulas (60.3%), acupuncture (14.1%) and single herbs (12.6%) accounted for the majority, followed by moxibustion (4.0%) and qigong (2.0%). The overage sufficient reporting rate of included TCM cohort studies according to the STROBE-cohort checklist was 42.9%. Comparing with Chinese literature, the reporting rates of English literature in most items were higher. Conclusion For the application of cohort studies to inform the effects of TCM interventions, the interventions assessed and conditions studied were diverse, the reporting quality was unsatisfied.

scholarly journals Practical and conceptual issues of clinical trial registration for Brazilian researchers

2015 ◽  
Vol 134 (1) ◽  
pp. 28-33 ◽  
Author(s):  
Carolina Gomes Freitas ◽  
Thomas Fernando Coelho Pesavento ◽  
Maurício Reis Pedrosa ◽  
Rachel Riera ◽  
Maria Regina Torloni
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
International Committee ◽  
New Drugs ◽  
Trial Registration ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Registration Process ◽  
Trial History ◽  
Definition Of

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

scholarly journals The Reporting Quality Assessment of Complex Interventions’ Articles in Traditional Chinese Medicine

2013 ◽  
Vol 2013 ◽  
pp. 1-8
Author(s):  
Meng Wu ◽  
Jingqing Hu ◽  
Biaoyan Liu
Keyword(s):  
Quality Control ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Complex Interventions ◽  
Reporting Quality ◽  
Chinese Journal ◽  
Inform Consent ◽  
Ethical Approval ◽  
Selection Of

Objective.To realize the current situation and problems of complex interventions’ clinical trials.Methods.Searching at Chinese Journal Integrated Traditional and Western Medicine and Journal of Traditional Chinese Medicine from 2007 to 2012 by hand, we identified complex interventions’ articles, and then we used the proposed criteria of complex interventions and CONSORT FOR TCM to evaluate.Results.All data is presented as counts with percentages and details in tables.Conclusion.Our evaluation presented that complex interventions have many defects: the selection of the intervention’s components lacks rationale, complex interventions were short of fundamental researches, components’ interactions were ambiguous, and the advantages of complex interventions were not mentioned. Furthermore, explanation of sample size, blind, quality control, ethical approval, and inform consent were neglected in different degrees.

Sign in / Sign up

Export Citation Format

Share Document