Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials
Objective Prospective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective registration is still commonly found. We assessed to what extent retrospective registration is reported transparently in journal publications and investigated factor...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/4/e069553.full |
| _version_ | 1797844141214793728 |
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| author | Daniel Strech Martin Haslberger Stefanie Gestrich |
| author_facet | Daniel Strech Martin Haslberger Stefanie Gestrich |
| author_sort | Daniel Strech |
| collection | DOAJ |
| description | Objective Prospective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective registration is still commonly found. We assessed to what extent retrospective registration is reported transparently in journal publications and investigated factors associated with transparent reporting.Design We used a dataset of trials registered in ClinicalTrials.gov or Deutsches Register Klinischer Studien, with a German University Medical Center as the lead centre, completed in 2009–2017, and with a corresponding peer-reviewed results publication. We extracted all registration statements from results publications of retrospectively registered trials and assessed whether they mention or justify the retrospective registration. We analysed associations of retrospective registration and reporting thereof with registration number reporting, International Committee of Medical Journal Editors (ICMJE) membership/-following and industry sponsorship using χ2 or Fisher exact test.Results In the dataset of 1927 trials with a corresponding results publication, 956 (53.7%) were retrospectively registered. Of those, 2.2% (21) explicitly report the retrospective registration in the abstract and 3.5% (33) in the full text. In 2.1% (20) of publications, authors provide an explanation for the retrospective registration in the full text. Registration numbers were significantly underreported in abstracts of retrospectively registered trials compared with prospectively registered trials. Publications in ICMJE member journals did not have statistically significantly higher rates of both prospective registration and disclosure of retrospective registration, and publications in journals claiming to follow ICMJE recommendations showed statistically significantly lower rates compared with non-ICMJE-following journals. Industry sponsorship of trials was significantly associated with higher rates of prospective registration, but not with transparent registration reporting.Conclusions Contrary to ICMJE guidance, retrospective registration is disclosed and explained only in a small number of retrospectively registered studies. Disclosure of the retrospective nature of the registration would require a brief statement in the manuscript and could be easily implemented by journals. |
| first_indexed | 2024-04-09T17:17:34Z |
| format | Article |
| id | doaj.art-b19264d57d5f4f018a53e3ad8a2ed212 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-09T17:17:34Z |
| publishDate | 2023-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-b19264d57d5f4f018a53e3ad8a2ed2122023-04-19T13:30:06ZengBMJ Publishing GroupBMJ Open2044-60552023-04-0113410.1136/bmjopen-2022-069553Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trialsDaniel Strech0Martin Haslberger1Stefanie Gestrich2QUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charite Universitatsmedizin Berlin, Berlin, GermanyQUEST Center for Responsible Research, Berlin Institute of Health at Charité, Berlin, GermanyQUEST Center for Responsible Research, Berlin Institute of Health at Charité, Berlin, GermanyObjective Prospective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective registration is still commonly found. We assessed to what extent retrospective registration is reported transparently in journal publications and investigated factors associated with transparent reporting.Design We used a dataset of trials registered in ClinicalTrials.gov or Deutsches Register Klinischer Studien, with a German University Medical Center as the lead centre, completed in 2009–2017, and with a corresponding peer-reviewed results publication. We extracted all registration statements from results publications of retrospectively registered trials and assessed whether they mention or justify the retrospective registration. We analysed associations of retrospective registration and reporting thereof with registration number reporting, International Committee of Medical Journal Editors (ICMJE) membership/-following and industry sponsorship using χ2 or Fisher exact test.Results In the dataset of 1927 trials with a corresponding results publication, 956 (53.7%) were retrospectively registered. Of those, 2.2% (21) explicitly report the retrospective registration in the abstract and 3.5% (33) in the full text. In 2.1% (20) of publications, authors provide an explanation for the retrospective registration in the full text. Registration numbers were significantly underreported in abstracts of retrospectively registered trials compared with prospectively registered trials. Publications in ICMJE member journals did not have statistically significantly higher rates of both prospective registration and disclosure of retrospective registration, and publications in journals claiming to follow ICMJE recommendations showed statistically significantly lower rates compared with non-ICMJE-following journals. Industry sponsorship of trials was significantly associated with higher rates of prospective registration, but not with transparent registration reporting.Conclusions Contrary to ICMJE guidance, retrospective registration is disclosed and explained only in a small number of retrospectively registered studies. Disclosure of the retrospective nature of the registration would require a brief statement in the manuscript and could be easily implemented by journals.https://bmjopen.bmj.com/content/13/4/e069553.full |
| spellingShingle | Daniel Strech Martin Haslberger Stefanie Gestrich Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials BMJ Open |
| title | Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials |
| title_full | Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials |
| title_fullStr | Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials |
| title_full_unstemmed | Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials |
| title_short | Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials |
| title_sort | reporting of retrospective registration in clinical trial publications a cross sectional study of german trials |
| url | https://bmjopen.bmj.com/content/13/4/e069553.full |
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