Correction of scientific literature: Too little, too late!

The Coronavirus Disease 2019 (COVID-19) pandemic has highlighted the limitations of the current scientific publication system, in which serious post-publication concerns are often addressed too slowly to be effective. In this Perspective, we offer suggestions to improve academia's willingness and ability to correct errors in an appropriate time frame.

Tracking changes between preprint posting and journal publication during a pandemic.

Amid the Coronavirus Disease 2019 (COVID-19) pandemic, preprints in the biomedical sciences are being posted and accessed at unprecedented rates, drawing widespread attention from the general public, press, and policymakers for the first time. This phenomenon has sharpened long-standing questions about the reliability of information shared prior to journal peer review. Does the information shared in preprints typically withstand the scrutiny of peer review, or are conclusions likely to change in the version of record? We assessed preprints from bioRxiv and medRxiv that had been posted and subsequently published in a journal through April 30, 2020, representing the initial phase of the pandemic response. We utilised a combination of automatic and manual annotations to quantify how an article changed between the preprinted and published version. We found that the total number of figure panels and tables changed little between preprint and published articles. Moreover, the conclusions of 7.2% of non-COVID-19-related and 17.2% of COVID-19-related abstracts undergo a discrete change by the time of publication, but the majority of these changes do not qualitatively change the conclusions of the paper.

Epidemiology, methodological quality, and reporting characteristics of systematic reviews and meta-analyses on coronavirus disease 2019: A cross-sectional study.

ABSTRACT: During the coronavirus disease 2019 (COVID-19) pandemic, convenient accessibility and rapid publication of studies related to the ongoing pandemic prompted shorter preparation time for studies. Whether the methodological quality and reporting characteristics of published systematic reviews (SRs)/meta-analyses are affected during the specific pandemic condition is yet to be clarified. This study aimed to evaluate the epidemiology, methodological quality, and reporting characteristics of published SRs/meta-analyses related to COVID-19.The Ovid Medline, Ovid Embase, Cochrane Library, and Web of Science electronic databases were searched to identify published SRs/meta-analyses related to the COVID-19 pandemic. Study screening, data extraction, and methodology quality assessment were performed independently by 2 authors. The methodology quality of included SRs/meta-analyses was evaluated using revised version of a measurement tool to assess SRs, and the reporting characteristics were assessed based on the preferred reporting items for SRs and meta-analyses guidelines.A total of 47 SRs/meta-analyses were included with a low to critically low methodological quality. The median number of days from the date of literature retrieval to the date that the study was first available online was 21 days; due to the limited time, only 7 studies had study protocols, and the studies focused on a wide range of COVID-19 topics. The rate of compliance to the preferred reporting items for SRs and meta-analyses checklists of reporting characteristics ranged from 14.9% to 100%. The rate of compliance to the items of protocol and registration, detailed search strategy, and assessment of publication bias was less than 50%.SRs/meta-analyses on COVID-19 were poorly conducted and reported, and thus, need to be substantially improved.

Evaluation of reporting quality of randomized controlled trials in patients with COVID-19 using the CONSORT statement.

OBJECTIVE: To evaluate the reporting quality of randomized controlled trials (RCTs) regarding patients with COVID-19 and analyse the influence factors. METHODS: PubMed, Embase, Web of Science and the Cochrane Library databases were searched to collect RCTs regarding patients with COVID-19. The retrieval time was from the inception to December 1, 2020. The CONSORT 2010 statement was used to evaluate the overall reporting quality of these RCTs. RESULTS: 53 RCTs were included. The study showed that the average reporting rate for 37 items in CONSORT checklist was 53.85% with mean overall adherence score of 13.02±3.546 (ranged: 7 to 22). The multivariate linear regression analysis showed the overall adherence score to the CONSORT guideline was associated with journal impact factor (P = 0.006), and endorsement of CONSORT statement (P = 0.014). CONCLUSION: Although many RCTs of COVID-19 have been published in different journals, the overall reporting quality of these articles was suboptimal, it can not provide valid evidence for clinical decision-making and systematic reviews. Therefore, more journals should endorse the CONSORT statement, authors should strictly follow the relevant provisions of the CONSORT guideline when reporting articles. Future RCTs should particularly focus on improvement of detailed reporting in allocation concealment, blinding and estimation of sample size.

Editorial: Reporting Clinical Trials with Important Modifications Due to Extenuating Circumstances, Including the COVID-19 Pandemic: CONSERVE 2021.

During 2020 and 2021, the COVID-19 pandemic has resulted in interruptions and cancellations of clinical trials and has delayed drug development in all areas except SARS-CoV-2 vaccine development. A further concern is the need to rapidly share anonymized datasets and improve opportunities to conduct randomized clinical trials (RCTs) in low-resource developing countries, particularly for oncology trials and for other infectious diseases. The Consolidated Standards of Reporting Trials (CONSORT) 2010 and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 currently guide the reporting of trial protocols and completed RCTs, respectively. Extenuating circumstances or unavoidable situations may occur that are beyond the control of study sponsors and investigators. On June 21, 2021, the CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstance (CONSERVE) was published. The scope of CONSERVE 2021 includes modifications that have substantive implications for the feasibility, ethical conduct, scientific content, and study analysis. This Editorial aims to provide the background to CONSERVE 2021 and show how these guidelines may reduce the number of clinical trials currently being paused or discontinued due to the COVID-19 pandemic, particularly in poorly resourced and developing countries.

Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement.

Importance: Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modifications is incomplete. Objective: As a joint extension for the CONSORT and SPIRIT reporting guidelines, CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) aims to improve reporting of trial protocols and completed trials that undergo important modifications in response to extenuating circumstances. Evidence: A panel of 37 international trial investigators, patient representatives, methodologists and statisticians, ethicists, funders, regulators, and journal editors convened to develop the guideline. The panel developed CONSERVE following an accelerated, iterative process between June 2020 and February 2021 involving (1) a rapid literature review of multiple databases (OVID Medline, OVID EMBASE, and EBSCO CINAHL) and gray literature sources from 2003 to March 2021; (2) consensus-based panelist meetings using a modified Delphi process and surveys; and (3) a global survey of trial stakeholders. Findings: The rapid review yielded 41 673 citations, of which 38 titles were relevant, including emerging guidance from regulatory and funding agencies for managing the effects of the COVID-19 pandemic on trials. However, no generalizable guidance for all circumstances in which trials and trial protocols might face unanticipated modifications were identified. The CONSERVE panel used these findings to develop a consensus reporting guidelines following 4 rounds of meetings and surveys. Responses were received from 198 professionals from 34 countries, of whom 90% (n = 178) indicated that they understood the concept definitions and 85.4% (n = 169) indicated that they understood and could use the implementation tool. Feedback from survey respondents was used to finalize the guideline and confirm that the guideline's core concepts were applicable and had utility for the trial community. CONSERVE incorporates an implementation tool and checklists tailored to trial reports and trial protocols for which extenuating circumstances have resulted in important modifications to the intended study procedures. The checklists include 4 sections capturing extenuating circumstances, important modifications, responsible parties, and interim data analyses. Conclusions and Relevance: CONSERVE offers an extension to CONSORT and SPIRIT that could improve the transparency, quality, and completeness of reporting important modifications to trials in extenuating circumstances such as COVID-19.

[COVID-19 and medical publications: How three articles have influenced the media and public decisions in France]. / Littérature médicale et COVID-19 : comment trois articles ont influencé les médias et la décision publique en France.

The present article details the publication process and the vicissitudes of three articles about SARS-CoV-2 and its related disease (COVID-19). The three articles were published one month apart between March and May 2020. Their mediatization led French health authorities to intervene. Our article does not focus on and does not assess the scientific quality of the articles presented, but only aims to open the reflection on medical publication. Beyond the description of these three specific cases, this article raises issues about article retraction, peer-reviewing, preprints, authorship and the dissemination of scientific medical information, including through the mass media. It discusses new publishing modes and the dissemination of published information in clinical research.

Is publication ethics becoming a casualty of Covid-19?

Public health emergencies require real-time, accurate information to guide effective and timely responses. This calls for rapid and timely publication of information to promote both its scientific validity and societal value. On the other hand, rapid publication poses a potential threat to the integrity of the information published. Inaccurate or incomplete information arises due to the difficulty in conducting rigorous studies during an ongoing emergency, and the race for the fame and prestige that come with being first. The balance between the potential risks and benefits of rapid publication can be achieved by adhering to the principles of publication ethics that promote the integrity, accuracy and value of scientific literature (1). We highlight ten potential challenges related to scientific publishing and dissemination of information during this pandemic, and the underlying principles of publication ethics that could guide us.

Understanding the COVID 19 Conundrum and Decluttering the scientific literature on COVID 19.

As COVID 19 continues to over burden the healthcare system globally, the scientists are relentlessly pursuing research and publishing copious data on relevant managements strategies for the infection. This short communication has attempted to simplify the available information on the subject in a manner that is easy to understand and implement in clinical setting. COVID 19 is not a single disease but a spectrum and should be classified based on clinical, radiological and laboratory parameters. A simple yet powerful way is to classify COVID 19 as COVIN - COVID Infection but no disease; COVIRI - COVID infection with predominant respiratory symptoms; COVIDI - COVID infection leading to an abnormal immune response and COVID S- referring to the sequalae of an acute COVID Infection. A clinical subtype specific approach may result in easier communication between healthcare providers which in turn may improve patient outcomes by providing targeted therapy.