Transparency and reporting characteristics of COVID-19 randomized controlled trials
Abstract Background In the context of the COVID-19 pandemic, randomized controlled trials (RCTs) are essential to support clinical decision-making. We aimed (1) to assess and compare the reporting characteristics of RCTs between preprints and peer-reviewed publications and (2) to assess whether repo...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2022-09-01
|
| Series: | BMC Medicine |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12916-022-02567-y |
| _version_ | 1797998667542560768 |
|---|---|
| author | Philipp Kapp Laura Esmail Lina Ghosn Philippe Ravaud Isabelle Boutron |
| author_facet | Philipp Kapp Laura Esmail Lina Ghosn Philippe Ravaud Isabelle Boutron |
| author_sort | Philipp Kapp |
| collection | DOAJ |
| description | Abstract Background In the context of the COVID-19 pandemic, randomized controlled trials (RCTs) are essential to support clinical decision-making. We aimed (1) to assess and compare the reporting characteristics of RCTs between preprints and peer-reviewed publications and (2) to assess whether reporting improves after the peer review process for all preprints subsequently published in peer-reviewed journals. Methods We searched the Cochrane COVID-19 Study Register and L·OVE COVID-19 platform to identify all reports of RCTs assessing pharmacological treatments of COVID-19, up to May 2021. We extracted indicators of transparency (e.g., trial registration, data sharing intentions) and assessed the completeness of reporting (i.e., some important CONSORT items, conflict of interest, ethical approval) using a standardized data extraction form. We also identified paired reports published in preprint and peer-reviewed publications. Results We identified 251 trial reports: 121 (48%) were first published in peer-reviewed journals, and 130 (52%) were first published as preprints. Transparency was poor. About half of trials were prospectively registered (n = 140, 56%); 38% (n = 95) made their full protocols available, and 29% (n = 72) provided access to their statistical analysis plan report. A data sharing statement was reported in 68% (n = 170) of the reports of which 91% stated their willingness to share. Completeness of reporting was low: only 32% (n = 81) of trials completely defined the pre-specified primary outcome measures; 57% (n = 143) reported the process of allocation concealment. Overall, 51% (n = 127) adequately reported the results for the primary outcomes while only 14% (n = 36) of trials adequately described harms. Primary outcome(s) reported in trial registries and published reports were inconsistent in 49% (n = 104) of trials; of them, only 15% (n = 16) disclosed outcome switching in the report. There were no major differences between preprints and peer-reviewed publications. Of the 130 RCTs published as preprints, 78 were subsequently published in a peer-reviewed journal. There was no major improvement after the journal peer review process for most items. Conclusions Transparency, completeness, and consistency of reporting of COVID-19 clinical trials were insufficient both in preprints and peer-reviewed publications. A comparison of paired reports published in preprint and peer-reviewed publication did not indicate major improvement. |
| first_indexed | 2024-04-11T10:52:22Z |
| format | Article |
| id | doaj.art-c04c9535a3464c76a84e3734c8e5567f |
| institution | Directory Open Access Journal |
| issn | 1741-7015 |
| language | English |
| last_indexed | 2024-04-11T10:52:22Z |
| publishDate | 2022-09-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medicine |
| spelling | doaj.art-c04c9535a3464c76a84e3734c8e5567f2022-12-22T04:28:52ZengBMCBMC Medicine1741-70152022-09-0120111410.1186/s12916-022-02567-yTransparency and reporting characteristics of COVID-19 randomized controlled trialsPhilipp Kapp0Laura Esmail1Lina Ghosn2Philippe Ravaud3Isabelle Boutron4Université Paris Cité, Inserm, INRAE, Centre of Research in Epidemiology and Statistics (CRESS)Université Paris Cité, Inserm, INRAE, Centre of Research in Epidemiology and Statistics (CRESS)Université Paris Cité, Inserm, INRAE, Centre of Research in Epidemiology and Statistics (CRESS)Université Paris Cité, Inserm, INRAE, Centre of Research in Epidemiology and Statistics (CRESS)Université Paris Cité, Inserm, INRAE, Centre of Research in Epidemiology and Statistics (CRESS)Abstract Background In the context of the COVID-19 pandemic, randomized controlled trials (RCTs) are essential to support clinical decision-making. We aimed (1) to assess and compare the reporting characteristics of RCTs between preprints and peer-reviewed publications and (2) to assess whether reporting improves after the peer review process for all preprints subsequently published in peer-reviewed journals. Methods We searched the Cochrane COVID-19 Study Register and L·OVE COVID-19 platform to identify all reports of RCTs assessing pharmacological treatments of COVID-19, up to May 2021. We extracted indicators of transparency (e.g., trial registration, data sharing intentions) and assessed the completeness of reporting (i.e., some important CONSORT items, conflict of interest, ethical approval) using a standardized data extraction form. We also identified paired reports published in preprint and peer-reviewed publications. Results We identified 251 trial reports: 121 (48%) were first published in peer-reviewed journals, and 130 (52%) were first published as preprints. Transparency was poor. About half of trials were prospectively registered (n = 140, 56%); 38% (n = 95) made their full protocols available, and 29% (n = 72) provided access to their statistical analysis plan report. A data sharing statement was reported in 68% (n = 170) of the reports of which 91% stated their willingness to share. Completeness of reporting was low: only 32% (n = 81) of trials completely defined the pre-specified primary outcome measures; 57% (n = 143) reported the process of allocation concealment. Overall, 51% (n = 127) adequately reported the results for the primary outcomes while only 14% (n = 36) of trials adequately described harms. Primary outcome(s) reported in trial registries and published reports were inconsistent in 49% (n = 104) of trials; of them, only 15% (n = 16) disclosed outcome switching in the report. There were no major differences between preprints and peer-reviewed publications. Of the 130 RCTs published as preprints, 78 were subsequently published in a peer-reviewed journal. There was no major improvement after the journal peer review process for most items. Conclusions Transparency, completeness, and consistency of reporting of COVID-19 clinical trials were insufficient both in preprints and peer-reviewed publications. A comparison of paired reports published in preprint and peer-reviewed publication did not indicate major improvement.https://doi.org/10.1186/s12916-022-02567-yCOVID-19Randomized controlled trialSelective outcome reportingSelection biasQuality of reportingPeer review; Completeness of reporting |
| spellingShingle | Philipp Kapp Laura Esmail Lina Ghosn Philippe Ravaud Isabelle Boutron Transparency and reporting characteristics of COVID-19 randomized controlled trials BMC Medicine COVID-19 Randomized controlled trial Selective outcome reporting Selection bias Quality of reporting Peer review; Completeness of reporting |
| title | Transparency and reporting characteristics of COVID-19 randomized controlled trials |
| title_full | Transparency and reporting characteristics of COVID-19 randomized controlled trials |
| title_fullStr | Transparency and reporting characteristics of COVID-19 randomized controlled trials |
| title_full_unstemmed | Transparency and reporting characteristics of COVID-19 randomized controlled trials |
| title_short | Transparency and reporting characteristics of COVID-19 randomized controlled trials |
| title_sort | transparency and reporting characteristics of covid 19 randomized controlled trials |
| topic | COVID-19 Randomized controlled trial Selective outcome reporting Selection bias Quality of reporting Peer review; Completeness of reporting |
| url | https://doi.org/10.1186/s12916-022-02567-y |
| work_keys_str_mv | AT philippkapp transparencyandreportingcharacteristicsofcovid19randomizedcontrolledtrials AT lauraesmail transparencyandreportingcharacteristicsofcovid19randomizedcontrolledtrials AT linaghosn transparencyandreportingcharacteristicsofcovid19randomizedcontrolledtrials AT philipperavaud transparencyandreportingcharacteristicsofcovid19randomizedcontrolledtrials AT isabelleboutron transparencyandreportingcharacteristicsofcovid19randomizedcontrolledtrials |