Exploring trial publication and research waste in COVID-19 randomised trials of hydroxychloroquine, corticosteroids, and vitamin D: a meta-epidemiological cohort study

{ 'indexed': {'date-parts': [[2024, 1, 24]], 'date-time': '2024-01-24T00:37:39Z', 'timestamp': 1706056659809}, 'reference-count': 27, 'publisher': 'Springer Science and Business Media LLC', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2024, 1, 23]], 'date-time': '2024-01-23T00:00:00Z', 'timestamp': 1705968000000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}, { 'start': { 'date-parts': [[2024, 1, 23]], 'date-time': '2024-01-23T00:00:00Z', 'timestamp': 1705968000000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}], 'funder': [{'name': 'Research, Evidence and Development Initiative', 'award': ['300342-104']}], 'content-domain': {'domain': ['link.springer.com'], 'crossmark-restriction': False}, 'abstract': '<jats:title>Abstract</jats:title><jats:sec>\n' ' <jats:title>Background</jats:title>\n' ' <jats:p>The global research response to the COVID-19 pandemic was impressive, ' 'but also led to an infodemic and considerable research waste. Registered, but unpublished ' 'trials added to this noise. We aimed to determine the proportion of registered randomised ' 'trials of common COVID-19 treatments that were published and to describe the characteristics ' 'of these trials to examine the association between trial characteristics, publication status ' 'and research waste.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>This meta-epidemiological cohort study used a sample of randomised ' 'trials of corticosteroids, hydroxychloroquine or vitamin D as treatments for COVID-19, ' 'registered between 1 November 2019 and 31 December 2021 and available via the WHO ICTRP ' 'portal. We searched for the trials’ published results up to 20 October 2022. We extracted the ' 'trial characteristics, analysing with descriptive statistics. We performed univariate ' 'logistic regression to examine the association between trials’ characteristics and ' 'publication status, followed by multiple logistic regression using significant ' 'characteristics to assess the association between trial characteristics and publication ' 'status.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>We identified 357 eligible trials on ICTRP. Of these, 107 (30%) had ' 'published or made their results available publicly by 20 October 2022, while 250 (70%) had ' 'not been published or shared their results publicly. Multiple logistic regression analysis ' 'showed that a larger target sample size was a significant positive predictor of publication ' 'with target sample sizes above 300 almost tripling the odds of publication (aOR: 2.75, 95% ' 'CI: 1.35 to 5.62).</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>Less than one third of registered trials made their results public ' 'and our findings identified that many trialists had not updated their trial registry entry ' 'with the trial status, results or both. Failure to share trial results publicly is a ' 'disservice to patients, clinicians and policy makers and adds to research waste.</jats:p>\n' ' </jats:sec>', 'DOI': '10.1186/s12874-023-02110-4', 'type': 'journal-article', 'created': {'date-parts': [[2024, 1, 23]], 'date-time': '2024-01-23T10:02:33Z', 'timestamp': 1706004153000}, 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Exploring trial publication and research waste in COVID-19 randomised trials of ' 'hydroxychloroquine, corticosteroids, and vitamin D: a meta-epidemiological cohort study', 'prefix': '10.1186', 'volume': '24', 'author': [ {'given': 'Lisa', 'family': 'Fincham', 'sequence': 'first', 'affiliation': []}, {'given': 'Ameer', 'family': 'Hohlfeld', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mike', 'family': 'Clarke', 'sequence': 'additional', 'affiliation': []}, {'given': 'Tamara', 'family': 'Kredo', 'sequence': 'additional', 'affiliation': []}, {'given': 'Michael', 'family': 'McCaul', 'sequence': 'additional', 'affiliation': []}], 'member': '297', 'published-online': {'date-parts': [[2024, 1, 23]]}, 'reference': [ { 'key': '2110_CR1', 'doi-asserted-by': 'publisher', 'first-page': '1', 'DOI': '10.26633/RPSP.2021.40', 'volume': '45', 'author': 'C Zielinski', 'year': '2021', 'unstructured': 'Zielinski C. 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