COVID-19 preprint studies take about 6 months to be published

Time from online preprint submission of randomized clinical trials to journal publication COVID-19 (new coronavirus infectious disease) Subjects range from two weeks to over a year, according to a new study.

Data from a team of Canadian researchers showed that it takes a median of more than six months for preprint research papers on COVID-19 to actually be published in journals. Significant delays in publication, and mixed results of preprint article publication based on trial sample size and risk of bias, point to a lack of unified strategies and priorities for professional review of current research on pandemic viruses. It tells a story.

Researchers led by Anthony D. Bai, M.D., Ph.D., of the Division of Infectious Diseases, Queen’s University School of Medicine, sought to interpret the time-to-journal publication of COVID-19 randomized clinical trial (RCT) preprints and the differences between studies. It was published as a preprint and eventually as a journal article.

Bai and colleagues emphasized the “drive” to provide RCT data surrounding COVID-19 as soon as possible to support clinical care strategies during the pandemic. They cited preprint successes such as the results of his RECOVERY trial of dexamethasone as a beneficial standard of care for COVID-19.

“However, preprints may not meet the standards required for scientific publication without peer review, are subject to change because the manuscript is not yet completed, and may contain errors or misinformation. “As a result, preprints can mislead the public.”

Studies to date have found differences between pairs of COVID-19 RCT preprints and final journal articles. A systematic review and meta-epidemiological analysis of investigators, based on preprints on the journal’s publication status, determined exactly how journal articles differed in time to publication, outcomes, analyses, results, and conclusions. I tried to answer

“We hypothesized that there is a significant time lag between preprint submission and publication in the journal, and that there are notable differences between preprints and corresponding published journal articles,” they wrote. .

The team conducted a literature search of the World Health Organization (WHO) COVID-19 database and Embase to identify preprint RCT articles published between 1 January and 31 December 2021. COVID-19 (new coronavirus infectious disease.

For the observed preprints, researchers conducted a literature search and found corresponding journal articles. Outcomes, including risk of bias and time to publication, were defined by independent reviewers and Cox proportional hazards regression models, respectively. Bai and his colleagues independently described differences in RCT trial pairs by means of results, analyses, findings, and conclusions.

The final evaluation included 152 preprints, of which 119 (78.3%) were published in the journal by 1 October 2022. Of the published RCTs, 65 (54.6%) were published with changes to outcomes, analyses, results or conclusions. The median time to publication was 186 days (range, 17–407 days). Two (1.7%) studies were published with conclusions that contradicted those contained in the preprint.

The team identified an association between larger RCT sample sizes and lower risk of bias for journal publications. RCT patients or sample size 201-1000 refer to RCTs with ≤200 samples (hazard ratio [HR], 1.23; 95% CI, 0.80–1.91). RCTs with more than 1000 samples were more than twice as likely to be published (HR, 2.19; 95% CI, 1.36 – 3.53).

Using RCTs at high risk of bias as references, researchers observed that RCTs at intermediate risk of bias were 77% more likely to be published (HR, 1.77; 95% CI, 1.02 – 3.09). The odds of a low-risk RCT were three times higher (HR, 3.01; 95% CI, 1.71 – 5.30).

Bai et al found that the time lag between preprint and publication in COVID-19 RCTs was ‘substantial’, similar to differences in outcomes, analyses, sample sizes, and results between preprint and publication in most RCTs. concluded that it is “substantial”. Among the most thought-provoking findings they noted was the need for more context related to preprint data, including RCTs published in journals.

“However, researchers should exercise caution in synthesizing and interpreting knowledge when including preprints, and should acknowledge that unpublished preprints may be at high risk of bias,” they said. wrote. “In this study, the primary outcome estimates and conclusions were generally consistent between the preprint and the corresponding journal article, so these updates are unlikely to change the overall conclusions.” increase.”

the study, “Comparison of Preprint Submissions of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles,” was published online at JAMA network open.