Methodological Rigor in COVID-19 Clinical Research – A Systematic Review and Case-Control Analysis

Abstract

<jats:p>Objective: To systematically evaluate the quality of reporting of currently available COVID-19 studies compared to historical controls. Design: A systematic review and case-control analysis Data sources: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials until May 14, 2020 Study selection: All original clinical literature evaluating COVID-19 or SARS-CoV2 were identified and 1:1 historical control of the same study type in the same published journal was matched from the previous year Data extraction: Two independent reviewers screened titles, abstracts, and full-texts and independently assessed methodological quality using Cochrane Risk of Bias Tool, Newcastle-Ottawa Scale, QUADAS-2 Score, or case series checklist. Results: 9895 titles and abstracts were screened and 686 COVID-19 articles were included in the final analysis in which 380 (55.4%) were case series, 199 (29.0%) were cohort, 63 (9.2%) were diagnostic, 38 (5.5%) were case-control, and 6 (0.9%) were randomized controlled trials. Overall, high quality/low-bias studies represented less than half of COVID-19 articles - 49.0% of case series, 43.9% of cohort, 31.6% of case-control, and 6.4% of diagnostic studies. We matched 539 control articles to COVID-19 articles from the same journal in the previous year for a final analysis of 1078 articles. The median time to acceptance was 13.0 (IQR, 5.0-25.0) days in COVID-19 articles vs. 110.0 (IQR, 71.0-156.0) days in control articles (p&lt;0.0001). Overall, methodological quality was lower in COVID-19 articles with 220 COVID-19 articles of high quality (41.0%) vs. 392 control articles (73.3%, p&lt;0.0001) with similar results when stratified by study design. In both unadjusted and adjusted logistic regression, COVID-19 articles were associated with lower methodological quality (odds ratio, 0.25; 95% CI, 0.20 to 0.33, p&lt;0.0001). Conclusion: Currently published COVID-19 studies were accepted more quickly and were found to be of lower methodological quality than comparative studies published in the same journal. Given the implications of these studies to medical decision making and government policy, greater effort to appropriately weigh the existing evidence in the context of emerging high-quality research is needed. Study registration: PROSPERO: CRD42020187318</jats:p>

Show me the study! Science by press release is not science

“…To the best of our knowledge, there is no evidence to support that most fast-tracked studies from 2020 have been wasteful and aimed at self-promotion [2]. Notwithstanding, COVID-19 studies were found to be of worse quality than their prepandemic counterparts [10][11][12][13] and that is an indication that the reward system in science could have been currently skewed towards recognition at the expense of reliability [2]. On the topic of incentives and recognition, it is worthy mentioning that citation is not a reliable proxy for quality assessment.…”

“…Accelerated time from submission to publication [6][7][8] and qualitative changes in the peer review processes [9] could imply lower quality of peer review in COVID-19 research. Evidence of lower quality of studies during the pandemic has indeed been found [2,[10][11][12]. Meanwhile, data availability practices remained largely unchanged, making claims still very hard to be independently verified [13].…”

“…Due to the urgency for solutions that the COVID-19 crisis imposed, more efficiency in scientific publication should had been associated with better and more readily available reliable science [14][15][16][17]. Instead, studies carried in the pandemic era proved to be less reliable [2,[10][11][12]18]. In addition, the trend to disseminate scientific findings through press releases and press conferences without immediate simultaneous access to the study has gained traction in 2020 and what was already far from ideal may have turned worse [18].…”

An immunization program against the COVID-19 infodemic

“…It will be a few years though before being able to analyze the retraction rate of COVID-related papers 5 by means of comparing it with a control group. Yet, the time from article submission to online publication of COVID-related articles accelerated remarkably in comparison to previous publication timeframes according to independent studies published in pre-print servers and in prestigious journals as well [6][7][8][9][10] . For example, two independent studies found that the median time to final acceptance was eight times faster for COVID-related articles as opposed to papers on other issues [8][9] .…”

“…Yet, the time from article submission to online publication of COVID-related articles accelerated remarkably in comparison to previous publication timeframes according to independent studies published in pre-print servers and in prestigious journals as well [6][7][8][9][10] . For example, two independent studies found that the median time to final acceptance was eight times faster for COVID-related articles as opposed to papers on other issues [8][9] . One of them found that the median time from article receipt to article being made available online was five times faster for COVID-related articles as opposed to papers on other issues and more than 10% of COVIDrelated studies were found to had been accepted within two days after submission in a pool of PubMed-indexed journals which have had their metadata analyzed 9 .…”