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1.
Medicine (Baltimore) ; 100(47): e27950, 2021 Nov 24.
Article in English | MEDLINE | ID: covidwho-1604259

ABSTRACT

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.


Subject(s)
COVID-19 , Meta-Analysis as Topic , Periodicals as Topic/standards , Publishing/standards , Systematic Reviews as Topic , Cross-Sectional Studies , Humans , Pandemics , Quality Control , SARS-CoV-2
2.
PLoS One ; 16(9): e0257093, 2021.
Article in English | MEDLINE | ID: covidwho-1435606

ABSTRACT

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.


Subject(s)
COVID-19/epidemiology , Publications/standards , Publishing/standards , Randomized Controlled Trials as Topic/standards , Data Management/standards , Guideline Adherence/standards , Humans , Journal Impact Factor , PubMed/standards , SARS-CoV-2/pathogenicity
4.
Med Sci Monit ; 27: e934514, 2021 Aug 30.
Article in English | MEDLINE | ID: covidwho-1378498

ABSTRACT

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.


Subject(s)
COVID-19/epidemiology , Clinical Protocols/standards , Guidelines as Topic , Publishing/standards , Randomized Controlled Trials as Topic/standards , Research Report/standards , SARS-CoV-2/physiology , COVID-19/virology , Humans , United States/epidemiology
6.
JAMA ; 326(3): 257-265, 2021 07 20.
Article in English | MEDLINE | ID: covidwho-1338165

ABSTRACT

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.


Subject(s)
COVID-19 , Guidelines as Topic , Randomized Controlled Trials as Topic/standards , Research Report/standards , Clinical Protocols , Delphi Technique , Humans , Publishing/standards , Surveys and Questionnaires
7.
Rev Med Interne ; 42(8): 583-590, 2021 Aug.
Article in French | MEDLINE | ID: covidwho-1318949

ABSTRACT

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.


Subject(s)
COVID-19 , Communications Media , Information Dissemination , Public Opinion , Publishing , COVID-19/epidemiology , Data Accuracy , Decision Making , France/epidemiology , Humans , Public Health Administration/standards , Publications/standards , Publications/statistics & numerical data , Publishing/standards , Publishing/statistics & numerical data , SARS-CoV-2/physiology
8.
Adv Skin Wound Care ; 33(9): 455-456, 2020 09.
Article in English | MEDLINE | ID: covidwho-1310941
10.
JAMA ; 326(3): 257-265, 2021 07 20.
Article in English | MEDLINE | ID: covidwho-1274634

ABSTRACT

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.


Subject(s)
COVID-19 , Guidelines as Topic , Randomized Controlled Trials as Topic/standards , Research Report/standards , Clinical Protocols , Delphi Technique , Humans , Publishing/standards , Surveys and Questionnaires
11.
Indian J Med Ethics ; VI(1): 1-3, 2021.
Article in English | MEDLINE | ID: covidwho-1257356

ABSTRACT

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.


Subject(s)
COVID-19 , Data Accuracy , Guidelines as Topic , Information Dissemination/ethics , Pandemics/ethics , Publishing/ethics , Publishing/standards , Research Report/standards , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , SARS-CoV-2
14.
Diabetes Metab Syndr ; 15(4): 102137, 2021.
Article in English | MEDLINE | ID: covidwho-1230440

ABSTRACT

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.


Subject(s)
COVID-19/epidemiology , Publishing/statistics & numerical data , Publishing/standards , Research Report/standards , SARS-CoV-2/isolation & purification , COVID-19/pathology , COVID-19/virology , Humans
17.
CMAJ Open ; 9(1): E295-E301, 2021.
Article in English | MEDLINE | ID: covidwho-1160661

ABSTRACT

BACKGROUND: The quality of case reports, which are often the first reported evidence for a disease, may be negatively affected by a rush to publication early in a pandemic. We aimed to determine the completeness of reporting (COR) for case reports published on coronavirus disease 2019 (COVID-19). METHODS: We conducted a systematic search of the PubMed database for all single-patient case reports of confirmed COVID-19 published from Jan. 1 to Apr. 24, 2020. All included case reports were assessed for adherence to the CARE (Case Report) 31-item checklist, which was used to create a composite COR score. The primary outcome was the mean COR score assessed by 2 independent raters. Secondary outcomes included whether there was a change in overall COR score with certain publication factors (e.g., publication date) and whether there was a linear relation between COR and citation count and between COR scores and social media attention. RESULTS: Our search identified 196 studies that were published in 114 unique journals. We found that the overall mean COR score was 54.4%. No one case report included all of the 31 CARE checklist items. There was no significant correlation between COR with either citation count or social media attention. INTERPRETATION: We found that the overall COR for case reports on COVID-19 was poor. We suggest that journals adopt common case-reporting standards to improve reporting quality.


Subject(s)
COVID-19/epidemiology , Checklist/standards , Publishing/standards , Research Report/standards , Bibliography of Medicine , Bibliometrics , COVID-19/diagnosis , COVID-19/virology , Data Management , Epidemiologic Studies , Ethics , Guideline Adherence , Humans , Outcome Assessment, Health Care , Research Report/trends , SARS-CoV-2/genetics , SARS-CoV-2/isolation & purification , Social Media/statistics & numerical data
18.
Recenti Prog Med ; 112(3): 173-181, 2021 03.
Article in Italian | MEDLINE | ID: covidwho-1123706

ABSTRACT

When a pandemic occurs, scientific research moves fast in order to achieve readily results, such as effective therapies to fight the SARS-CoV-2 and vaccines. But this high-speed science, engaged by the emergency and characterized by the explosion of online publications in preprint form not subject to scrutiny by peer reviewers, carries some risks. And it represents a challenge to maintain research integrity and to comply with those globally recognized standard principles of fairness. Competition and the pressure to publish immediately - a way of encouraging rapid data sharing - can favor the dissemination of incomplete if not erroneous results obtained from partial studies, which feed false news, such as the benefits of a drug, and illusory hopes. It is commonly through press releases that "speed science" disseminates information to an audience that wants to be informed and reassured. Financial and political interests often mix with the urgency to find solutions. Covid-19 has highlighted in particular the risk of a politicization of science at the expense of transparency.


Subject(s)
COVID-19 , Pandemics , Publishing/standards , Research/standards , SARS-CoV-2 , Adenosine Monophosphate/analogs & derivatives , Adenosine Monophosphate/economics , Adenosine Monophosphate/supply & distribution , Adenosine Monophosphate/therapeutic use , Alanine/analogs & derivatives , Alanine/economics , Alanine/supply & distribution , Alanine/therapeutic use , Antiviral Agents/economics , Antiviral Agents/supply & distribution , Antiviral Agents/therapeutic use , COVID-19 Vaccines/adverse effects , Disease Outbreaks , Drug Approval , European Union , Humans , Influenza, Human/drug therapy , Influenza, Human/economics , Influenza, Human/epidemiology , Influenza, Human/prevention & control , Information Dissemination , Informed Consent , Oseltamivir/economics , Oseltamivir/supply & distribution , Oseltamivir/therapeutic use , Peer Review, Research , Periodicals as Topic , Politics , Risk , Time Factors , United States
19.
J Med Internet Res ; 23(3): e22219, 2021 03 02.
Article in English | MEDLINE | ID: covidwho-1088863

ABSTRACT

Coincident with the tsunami of COVID-19-related publications, there has been a surge of studies using real-world data, including those obtained from the electronic health record (EHR). Unfortunately, several of these high-profile publications were retracted because of concerns regarding the soundness and quality of the studies and the EHR data they purported to analyze. These retractions highlight that although a small community of EHR informatics experts can readily identify strengths and flaws in EHR-derived studies, many medical editorial teams and otherwise sophisticated medical readers lack the framework to fully critically appraise these studies. In addition, conventional statistical analyses cannot overcome the need for an understanding of the opportunities and limitations of EHR-derived studies. We distill here from the broader informatics literature six key considerations that are crucial for appraising studies utilizing EHR data: data completeness, data collection and handling (eg, transformation), data type (ie, codified, textual), robustness of methods against EHR variability (within and across institutions, countries, and time), transparency of data and analytic code, and the multidisciplinary approach. These considerations will inform researchers, clinicians, and other stakeholders as to the recommended best practices in reviewing manuscripts, grants, and other outputs from EHR-data derived studies, and thereby promote and foster rigor, quality, and reliability of this rapidly growing field.


Subject(s)
COVID-19/epidemiology , Data Collection/methods , Electronic Health Records , Data Collection/standards , Humans , Peer Review, Research/standards , Publishing/standards , Reproducibility of Results , SARS-CoV-2/isolation & purification
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