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General practice / Family practice
Original research
Reporting of adverse events, conflict of interest and funding in randomised controlled trials of antibiotics: a secondary analysis
  1. Mina Bakhit1,
  2. Mark Jones1,
  3. Jenalle Baker2,
  4. Ramil Nair3,
  5. Kylie Yan3,
  6. Chris Del Mar1,
  7. Anna Mae Scott1
  1. 1Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Queensland, Australia
  2. 2Griffith University Faculty of Health, Gold Coast, Queensland, Australia
  3. 3Bond University Faculty of Health Sciences and Medicine, Gold Coast, Queensland, Australia
  1. Correspondence to Dr Anna Mae Scott; ascott{at}bond.edu.au

Abstract

Objectives Transparent reporting of trials is necessary to assess their internal and external validity. Currently, little is known about the quality of reporting in antibiotics trials. Our study investigates the reporting of adverse events, conflicts of interest and funding information in trials of penicillins, cephalosporins and macrolides.

Design A secondary analysis of trials included in a convenience sample of three systematic reviews.

Methods All randomised controlled trials included in the systematic reviews were included, although duplicates were removed. Eligible trials compared the specified antibiotics to placebo, for any indication. Author pairs independently extracted the data on reporting of adverse events from parent reviews, and data on funding and conflict of interest information from the trial reports. We calculated the overall proportion of trials reporting adverse events, conflict of interest information and funding information, and their proportion before and after the publication of the Consolidated Standards of Reporting Trials (CONSORT) 2001 Statement.

Results We included 432 trials. Overall, 62% of trials reported adverse events of any kind, although reporting of deaths or antibiotic resistance was less frequent (20% and 37%, respectively). Conflict-of-interest information was provided in 26% of the trials, and funding information was provided in 66% of the trials. There was no significant difference in reporting of adverse events before and after the publication of CONSORT 2001 Statement (62% vs 62%, p=0.92). Conflict of interest statements were provided more frequently (2% vs 55%, p<0.001) and conflict was present more often (0% vs 14%, p<0.001). There was no difference in the provision of the information about trial funding before (62%) and after (70%) CONSORT 2001 publication.

Conclusions Information about adverse events, conflict of interest and funding, remains under-reported in trials of antibiotics.

  • adverse events
  • primary care
  • public health

Data availability statement

The full list of RCTs analysed is provided in online supplemental appendix 1. Further data are available from the authors on reasonable request.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2020-045406

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    Data availability statement

    The full list of RCTs analysed is provided in online supplemental appendix 1. Further data are available from the authors on reasonable request.

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    Footnotes

    • Twitter @Mina_Bakhit

    • Contributors AMS and CDM conceived and designed the project. MB, JB, RN, KY and AMS extracted the data. MJ conducted the analyses. All authors (MB, MJ, JB, RN, KY, CDM and AMS) contributed to writing and critical revisions of drafts of the manuscript.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.