COVID-19 randomised trial protocols: rapid publication without barriers

Treweek, Shaun; Jüni, Peter; Li, Tianjing; Collin, Jonathan; Briel, Matthias; Chan, An Wen; Hemming, Karla; Meurer, William J; Sydes, Matthew R.; Grimshaw, Jeremy

doi:10.1186/s13063-020-04304-3

Cited by 6 publications

(9 citation statements)

References 2 publications

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“…Registration improves the transparency of TCM CTs by making protocols available to the public. Publicity, however, is invalid if the results do not appear in a journal [ 21 ]. Therefore, it is necessary not only to provide sufficient information in the registration but also to provide a prerequisite for quality evaluation, i.e., to prevent reporting bias.…”

Section: Discussionmentioning

confidence: 99%

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

Kuang

Cai

et al. 2021

Trials

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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.

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Section: Discussionmentioning

confidence: 99%

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

Kuang

Cai

et al. 2021

Trials

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“…This highlights two important points. First, despite the high level of commitment the conduct of RCTs faces a number of constraints and challenges [ 34 , 35 ]. Second, that the only preventative measures the world currently possessed are social distancing, wearing of masks and hand hygiene [ 7 ], until effective prophylactic and vaccine candidates can be identified.…”

Section: Discussionmentioning

confidence: 99%

Prophylaxis for COVID-19: a systematic review

Smit¹,

Marinosci²,

Agoritsas³

et al. 2021

Clinical Microbiology and Infection

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Background: While the landscape of vaccine and treatment candidates against the novel coronavirus disease 2019 (COVID-19) has been reviewed systematically, prophylactic candidates remain unexplored. Objectives: To map pre-and postexposure prophylactic (PrEP and PEP) candidate for COVID-19. Data sources: PubMed/Medline, Embase, International Committee of Medical Journal Editors and International Clinical Trials Registry Platform clinical trial registries and medRxiv. Study eligibility criteria and participants: All studies in humans or animals and randomized controlled trials (RCTs) in humans reporting primary data on prophylactic candidates against COVID-19, excluding studies focused on key populations. Interventions: PrEP and PEP candidate for COVID-19. Methods: Systematic review and qualitative synthesis of COVID-19 PrEP and PEP studies and RCTs complemented by search of medRxiv and PubMed and Embase for studies reporting RCT outcomes since systematic review search completion. Results: We identified 13 studies (from 2119 database records) and 117 RCTs (from 5565 RCTs listed in the registries) that met the inclusion criteria. Non-RCT studies reported on cross-sectional studies using hydroxychloroquine (HCQ) in humans (n ¼ 2) or reported on animal studies (n ¼ 7), most of which used antibodies. All five completed RCTs focused on the use of HCQ as either PrEP or PEP, and these and the cross-sectional studies reported no prophylactic effect. The majority of ongoing RCTs evaluated HCQ or other existing candidates including nonesevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, anti(retro)virals or use of vitamins and supplements. Conclusions: The key message from completed studies and RCTs seems to be that HCQ does not work. There is little evidence regarding other compounds, with all RCTs using candidates other than HCQ still ongoing. It remains to be seen if the portfolio of existing molecules being evaluated in RCTs will identify successful prophylaxis against COVID-19 or if there is a need for the development of new candidates.

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“…(4) All stakeholders involved in academic research and scientific publishing have directed efforts to enable an efficient publication outflow: governments and supporting agencies are releasing special funding and grants for research about COVID-19; ethics committees and other regulatory agencies are prioritizing COVID-19-related projects; (5) publishers are applying open access policies to COVID-19 articles; and journals are reviewing COVID-19 articles using fast-track processes. (6,7) All these efforts have the ultimate goal of enhancing knowledge and generating evidence about COVID-19. From an evidence-based perspective, meta-analyses are usually regarded as the experimental approach that generates the highest level of scientific evidence.…”

Section: ❚ Introductionmentioning

confidence: 99%

COVID-19 meta-analyses: a scoping review and quality assessment

Pires¹,

Bezerra²,

Oliveira³

et al. 2021

Einstein (São Paulo)

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Objective: To carry out a scoping review of the meta-analyses published regarding about coronavirus disease 2019 (COVID-19), evaluating their main characteristics, publication trends and methodological quality. Methods: A bibliometric search was performed in PubMed ® , Scopus and Web of Science, focusing on meta-analyses about COVID-2019 disease. Bibliometric and descriptive data for the included articles were extracted and the methodological quality of the included metaanalyses was evaluated using A Measurement Tool to Assess Systematic Reviews. Results: A total of 348 meta-analyses were considered eligible. The first meta-analysis about COVID-19 disease was published on February 26, 2020, and the number of meta-analyses has grown rapidly since then. Most of them were published in infectious disease and virology journals. The greatest number come from China, followed by the United States, Italy and the United Kingdom. On average, these meta-analyses included 23 studies and 15,200 participants. Overall quality was remarkably low, and only 8.9% of them could be considered as of high confidence level. Conclusion: Although welldesigned meta-analyses about COVID-19 disease have already been published, the majority are of low quality. Thus, all stakeholders playing a role in COVID-19 deseases, including policy makers, researchers, publishers and journals, should prioritize well-designed meta-analyses, performed only when the background information seem suitable, and discouraging those of low quality or that use suboptimal methods.

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COVID-19 randomised trial protocols: rapid publication without barriers

Cited by 6 publications

References 2 publications

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

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

Prophylaxis for COVID-19: a systematic review

COVID-19 meta-analyses: a scoping review and quality assessment

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