Completeness and consistency of primary outcome reporting in COVID-19 publications in the early pandemic phase: a descriptive study
Abstract Background The COVID-19 pandemic saw a steep increase in the number of rapidly published scientific studies, especially early in the pandemic. Some have suggested COVID-19 trial reporting is of lower quality than typical reports, but there is limited evidence for this in terms of primary ou...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-07-01
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| Series: | BMC Medical Research Methodology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12874-023-01991-9 |
| _version_ | 1797769458262999040 |
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| author | Marlene Stoll Saskia Lindner Bernd Marquardt Maia Salholz-Hillel Nicholas J. DeVito David Klemperer Klaus Lieb |
| author_facet | Marlene Stoll Saskia Lindner Bernd Marquardt Maia Salholz-Hillel Nicholas J. DeVito David Klemperer Klaus Lieb |
| author_sort | Marlene Stoll |
| collection | DOAJ |
| description | Abstract Background The COVID-19 pandemic saw a steep increase in the number of rapidly published scientific studies, especially early in the pandemic. Some have suggested COVID-19 trial reporting is of lower quality than typical reports, but there is limited evidence for this in terms of primary outcome reporting. The objective of this study was to assess the prevalence of completely defined primary outcomes reported in registry entries, preprints, and journal articles, and to assess consistent primary outcome reporting between these sources. Methods This is a descriptive study of a cohort of registered interventional clinical trials for the treatment and prevention of COVID-19, drawn from the DIssemination of REgistered COVID-19 Clinical Trials (DIRECCT) study dataset. The main outcomes are: 1) Prevalence of complete primary outcome reporting; 2) Prevalence of consistent primary outcome reporting between registry entry and preprint as well as registry entry and journal article pairs. Results We analyzed 87 trials with 116 corresponding publications (87 registry entries, 53 preprints and 63 journal articles). All primary outcomes were completely defined in 47/87 (54%) registry entries, 31/53 (58%) preprints and 44/63 (70%) journal articles. All primary outcomes were consistently reported in 13/53 (25%) registry-preprint pairs and 27/63 (43%) registry-journal article pairs. No primary outcome was specified in 13/53 (25%) preprints and 8/63 (13%) journal articles. In this sample, complete primary outcome reporting occurred more frequently in trials with vs. without involvement of pharmaceutical companies (76% vs. 45%), and in RCTs vs. other study designs (68% vs. 49%). The same pattern was observed for consistent primary outcome reporting (with vs. without pharma: 56% vs. 12%, RCT vs. other: 43% vs. 22%). Conclusions In COVID-19 trials in the early phase of the pandemic, all primary outcomes were completely defined in 54%, 58%, and 70% of registry entries, preprints and journal articles, respectively. Only 25% of preprints and 43% of journal articles reported primary outcomes consistent with registry entries. |
| first_indexed | 2024-03-12T21:09:16Z |
| format | Article |
| id | doaj.art-b250256f95c244f19fb30d9632b39152 |
| institution | Directory Open Access Journal |
| issn | 1471-2288 |
| language | English |
| last_indexed | 2024-03-12T21:09:16Z |
| publishDate | 2023-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Research Methodology |
| spelling | doaj.art-b250256f95c244f19fb30d9632b391522023-07-30T11:18:37ZengBMCBMC Medical Research Methodology1471-22882023-07-0123111110.1186/s12874-023-01991-9Completeness and consistency of primary outcome reporting in COVID-19 publications in the early pandemic phase: a descriptive studyMarlene Stoll0Saskia Lindner1Bernd Marquardt2Maia Salholz-Hillel3Nicholas J. DeVito4David Klemperer5Klaus Lieb6Department of Psychiatry and Psychotherapy, University Medical Center of the Johannes Gutenberg University MainzDepartment of Psychiatry and Psychotherapy, University Medical Center of the Johannes Gutenberg University MainzDepartment of Psychiatry and Psychotherapy, University Medical Center of the Johannes Gutenberg University MainzQUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charité Universitätsmedizin BerlinBennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of OxfordOstbayrische Technische Hochschule RegensburgDepartment of Psychiatry and Psychotherapy, University Medical Center of the Johannes Gutenberg University MainzAbstract Background The COVID-19 pandemic saw a steep increase in the number of rapidly published scientific studies, especially early in the pandemic. Some have suggested COVID-19 trial reporting is of lower quality than typical reports, but there is limited evidence for this in terms of primary outcome reporting. The objective of this study was to assess the prevalence of completely defined primary outcomes reported in registry entries, preprints, and journal articles, and to assess consistent primary outcome reporting between these sources. Methods This is a descriptive study of a cohort of registered interventional clinical trials for the treatment and prevention of COVID-19, drawn from the DIssemination of REgistered COVID-19 Clinical Trials (DIRECCT) study dataset. The main outcomes are: 1) Prevalence of complete primary outcome reporting; 2) Prevalence of consistent primary outcome reporting between registry entry and preprint as well as registry entry and journal article pairs. Results We analyzed 87 trials with 116 corresponding publications (87 registry entries, 53 preprints and 63 journal articles). All primary outcomes were completely defined in 47/87 (54%) registry entries, 31/53 (58%) preprints and 44/63 (70%) journal articles. All primary outcomes were consistently reported in 13/53 (25%) registry-preprint pairs and 27/63 (43%) registry-journal article pairs. No primary outcome was specified in 13/53 (25%) preprints and 8/63 (13%) journal articles. In this sample, complete primary outcome reporting occurred more frequently in trials with vs. without involvement of pharmaceutical companies (76% vs. 45%), and in RCTs vs. other study designs (68% vs. 49%). The same pattern was observed for consistent primary outcome reporting (with vs. without pharma: 56% vs. 12%, RCT vs. other: 43% vs. 22%). Conclusions In COVID-19 trials in the early phase of the pandemic, all primary outcomes were completely defined in 54%, 58%, and 70% of registry entries, preprints and journal articles, respectively. Only 25% of preprints and 43% of journal articles reported primary outcomes consistent with registry entries.https://doi.org/10.1186/s12874-023-01991-9Primary outcomeDiscrepancyReporting qualityMethodological qualityCOVID-19Trial registry |
| spellingShingle | Marlene Stoll Saskia Lindner Bernd Marquardt Maia Salholz-Hillel Nicholas J. DeVito David Klemperer Klaus Lieb Completeness and consistency of primary outcome reporting in COVID-19 publications in the early pandemic phase: a descriptive study BMC Medical Research Methodology Primary outcome Discrepancy Reporting quality Methodological quality COVID-19 Trial registry |
| title | Completeness and consistency of primary outcome reporting in COVID-19 publications in the early pandemic phase: a descriptive study |
| title_full | Completeness and consistency of primary outcome reporting in COVID-19 publications in the early pandemic phase: a descriptive study |
| title_fullStr | Completeness and consistency of primary outcome reporting in COVID-19 publications in the early pandemic phase: a descriptive study |
| title_full_unstemmed | Completeness and consistency of primary outcome reporting in COVID-19 publications in the early pandemic phase: a descriptive study |
| title_short | Completeness and consistency of primary outcome reporting in COVID-19 publications in the early pandemic phase: a descriptive study |
| title_sort | completeness and consistency of primary outcome reporting in covid 19 publications in the early pandemic phase a descriptive study |
| topic | Primary outcome Discrepancy Reporting quality Methodological quality COVID-19 Trial registry |
| url | https://doi.org/10.1186/s12874-023-01991-9 |
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