Publication status of completed registered studies in paediatric appendicitis: a cross-sectional analysis

Abstract

ObjectiveAppendicitis 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 While the management of paediatric appendicitis is evolving, the precise amount of unpublished completed trials, potentially introducing bias into meta-analyses, is unknown.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Selective reporting may introduce bias into evidence-based clinical decision-making, and the current, precise extent of unpublished results in paediatric appendicitis is unknown.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.DesignCross sectional analysis. STrengthening the Reporting of OBservational studies in Epidemiology criteria were applied for design and analysis.Setting and participantsClinicalTrials.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/exposureObservational analysis.Primary and secondary outcome measuresThe proportion of published and unpublished studies was calculated. Subgroup analysis included studies on surgical procedures, diagnosis, antibiotic treatment and pain management.ResultsOut of n=52 completed clinical studies involving children with appendicitis, n=33 (63%) were published and n=19 (37%) were unpublished.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.ConclusionDespite 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importance of appendicitis in clinical practice for the paediatric surgeon, there remains scientific uncertainty due to unpublished clinical trial results with room for improvement in the future.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.

Clinical Trials on Diabetic Nephropathy: A Cross-Sectional Analysis

“…Since treatment options and decisions are often based on the results of clinical trials, knowledge of the outcome of these studies is of great importance. In our analysis, 31% of the completed phase III clinical trials on DN remained unpublished, which is in line with previous findings on phase III clinical trials on other diseases [ 34 – 36 ]. The high number of undisclosed clinical trials may lead to an underestimation of the relevance of DN in the medical literature and thereby hinder a correct risk–benefit assessment of a certain intervention.…”

Publication rate and research topics of studies in pediatric kidney transplantation

“…However, recent investigations on the publication rate of registered clinical trials show that there might be a risk of selective reporting of study results in all fields of medicine including pediatric subspecialties. For example, the publication rate of studies in children is currently as low as 63% (pediatric appendicitis) or 58% (pediatric liver transplantation) 7‐9 …”

“…For example, the publication rate of studies in children is currently as low as 63% (pediatric appendicitis) or 58% (pediatric liver transplantation). [7][8][9] The reasons underlying this incomplete reporting of study results remain largely unknown. However, selective non-publication of negative results could result in a publication bias with presumable impact on clinical decision-making.…”

Decision-making in acute viral bronchiolitis: A universal guideline and a publication gap

“…However, it is increasingly noted that the results of many clinical trials are not reported in a timely manner or not reported at all. Such selective reporting of study results, known as publication bias or publication gap has been observed in a various fields of pediatrics [ 5 – 8 ]. Given the discrepancy between the few treatment options recommended by the AAP guideline and the widespread use of various other therapeutic approaches, we were wondering whether the actual decision making might be influenced by such a publication gap.…”