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Evidence based practice
Research
Publication status of completed registered studies in paediatric appendicitis: a cross-sectional analysis
  1. Thomas Breil1,
  2. Michael Boettcher2,
  3. Georg F Hoffmann1,3,
  4. Markus Ries3
  1. 1 Pediatric Gastroenterology and Hepatology, Center for Pediatric and Adolescent Medicine, Heidelberg University Hospital, Heidelberg, Germany
  2. 2 Pediatric Surgery, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany
  3. 3 Pediatric Neurology and Metabolic Medicine, Center for Pediatric and Adolescent Medicine, Heidelberg University Hospital, Heidelberg, Germany
  1. Correspondence to Professor Markus Ries; markus.ries{at}uni-heidelberg.de

Abstract

Objective Appendicitis is considered the most frequent surgical emergency in children. While the management of paediatric appendicitis is evolving, the precise amount of unpublished completed trials, potentially introducing bias into meta-analyses, is unknown. Controversial issues include the appropriate choice of surgical procedures, criteria for diagnosis of appendicitis, the role of antibiotic treatment and pain management. Selective reporting may introduce bias into evidence-based clinical decision-making, and the current, precise extent of unpublished results in paediatric appendicitis is unknown. We therefore assessed the publication status of completed clinical studies involving children registered on ClinicalTrials.gov.

Design Cross sectional analysis. STrengthening the Reporting of OBservational studies in Epidemiology criteria were applied for design and analysis.

Setting and participants ClinicalTrials.gov was queried for completed studies which were matched to publications on ClinicalTrials.gov, PubMed or Google Scholar. If no publication could be identified, principal investigators were contacted.

Interventions/exposure Observational analysis.

Primary and secondary outcome measures The proportion of published and unpublished studies was calculated. Subgroup analysis included studies on surgical procedures, diagnosis, antibiotic treatment and pain management.

Results Out of n=52 completed clinical studies involving children with appendicitis, n=33 (63%) were published and n=19 (37%) were unpublished. Eighty-three per cent (n=43/52) of clinical trials assessed the above-listed controversial issues. Diagnostic studies were most rigorously published (91% of trials reported), data on surgical procedures, antibiotic and pain management were less transparent. Sixty-six per cent of interventional studies and 60% of randomised studies were published. Median time-to-publication, for example, the delay between completion of the trial until public availability of the results was 24 (IQR 12–36), range 2–92 months.

Conclusion Despite the importance of appendicitis in clinical practice for the paediatric surgeon, there remains scientific uncertainty due to unpublished clinical trial results with room for improvement in the future. These data are helpful in framing the shifting paradigms in paediatric appendicitis because it adds transparency to the debate.

  • paediatric surgery
  • pain management
  • ethics (see medical ethics)
  • quality in health care

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-2018-021684

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    Footnotes

    • Contributors Substantial contributions to conception or design of the work, or the acquisition, analysis, or interpretation of data for the work: TB, MB, GFH, MR. Drafting of the work or revising it critically for important intellectual content: TB, MB, GFH, MR. Final approval of the version to be published: TB, MB, GFH, MR. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved: TB, MB, GFH, MR.

    • Funding We acknowledge financial support by Deutsche Forschungsgemeinschaft within the funding programme Open Access Publishing, by the Baden-Württemberg Ministry of Science, Research and the Arts and by Ruprecht-Karls-Universität Heidelberg.

    • Competing interests MR received consultancy fees or research grants from Alexion, GSK, Oxyrane and Shire unrelated to the subject of this project.

    • Patient consent Not required.

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

    • Data sharing statement All data are in the manuscript.