An Assessment of Publication Status of Pediatric Liver Transplantation Studies

Breil, Thomas; Wenning, Daniel; Teufel, Ulrike; Hoffmann, Georg F.; Ries, Markus

doi:10.1371/journal.pone.0168251

Cited by 9 publications

(12 citation statements)

References 12 publications

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“…Unfortunately, the low publication rate for studies on ED that we found in our analysis is in line with other published observations. Anderson et al recently reported that only 38.3% of all completed or prematurely terminated trials registered at ClinicalTrials.gov were published 15 , and we came to similar conclusions when testing for publication bias in fields as diverse as pediatric liver transplantation 16 or autism 17 . Publication of the results gathered in clinical trials involving human subjects is considered an ethical imperative 18 .…”

Section: Discussionsupporting

confidence: 81%

Unpublished clinical studies in pediatric emergence delirium – a cross sectional analysis

Meyburg

Ries

2020

Preprint

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Objectives: Emergence delirium (ED) is a frequent and potentially serious complication of general anesthesia in children. Although there are various treatment strategies, no general management recommendations can be made. Selective reporting of study results may impair clinical decision making. We therefore analyzed whether the results of completed registered clinical studies in patients with pediatric ED are publically available or remain unpublished. Design: cross sectional analysis Setting: ClinicalTrials.gov and ClinicalTrialsRegister.eu Participants and outcome measures: We determined the proportion of published and unpublished studies registered at ClinicalTrials.gov and ClinicalTrialsRegister.eu that were marked as completed by September 1st 2018. The major trial and literature databases were used to search for publications. In addition, the study investigators were contacted directly. Results: Of the 44 registered studies on pediatric ED, only 24 (54%) have been published by September 2019. Published trials contained data from n=2556 patients, whereas n=1644 patients were enrolled in unpublished trials. Median time to publication was 19 months. Studies completed in recent years were published faster, but still only 9 of 25 trials were published within 12 months after completion. Conclusion: There is a distinct publication gap in clinical research in pediatric ED that may have an impact on clinical practice.

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Section: Discussionsupporting

confidence: 81%

Unpublished clinical studies in pediatric emergence delirium – a cross sectional analysis

Meyburg

Ries

2020

Preprint

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“…Similar issues exist in other challenging areas of paediatric medicine, such as epilepsy, autism and liver transplantation. 15–17 22 …”

Section: Discussionmentioning

confidence: 99%

“…Selective reporting of clinical trial results introduces bias into evidence-based clinical decision-making. 15–17 The precise extent of bias in paediatric appendicitis is unknown. We therefore assessed the public availability of study results of completed clinical studies involving children with appendicitis registered in the major clinical trial database.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2018

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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.

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“…A trend towards improvement in terms of timely, pubic availability of results exists also in other areas of paediatric medicine, such as epilepsy, autism and liver transplantation, even if a considerable amount of study data from registered and completed studies is still missing today. 32–34 41 …”

Section: Discussionmentioning

confidence: 99%

“…As the current literature shows, however, unselective reporting of study results in paediatrics must still be considered. 32–34 …”

Section: Introductionmentioning

confidence: 99%

Cross-sectional analysis on publication status and age representation of clinical studies addressing mechanical ventilation and ventilator-induced lung injury in infants and children

et al. 2018

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ObjectivesWe determined the number and time-to-public availability of study results of published and unpublished clinical studies in paediatric mechanical ventilation (MV) and ventilator-induced lung injury (VILI), which were registered as completed on ClinicalTrials.gov. Furthermore, we explored the pattern of represented research study subtopics and the corresponding study populations.SettingLiterature search based on ClinicalTrials.gov, PubMed and Google Scholar from 9 July 2017 to 27 September 2017.Primary and secondary outcome measuresAssessment, if studies included in our analysis had been published. Assessment of primary research focus, patient enrolment and age representation of the analysed studies.ResultsWe identified n=109 registered and completed clinical studies on paediatric MV and VILI (enrolment: 22 233 participants). 71% were published, including data from 18 647 subjects. 29% of studies were unpublished, containing data from 3586 subjects. Median time-to-public availability of study results was 22 (IQR, 12.8–41.5) months. The most important study subtopics were biophysical and technical aspects of MV (32 studies), administration of drugs to mitigate VILI through various mechanisms (40 studies) and diagnostic procedures (16 studies). n=66/109 (61%) studies exclusively focused on children below 1 year of age and n=2/109 (2%) exclusively on children between 1 and 14 years.ConclusionsOne-third of clinical studies in paediatric MV and VILI registered as completed on ClinicalTrials.gov remained unpublished and contained data on 3586 study participants. The overall median time-to-public availability of study results was longer than the deadline of 12 months mandated by the Food and Drug Administration Amendment Act of 2007. Important and clinically relevant research study subtopics were represented in the research questions investigated in paediatric MV and VILI. The study population was skewed towards children younger than 1 year which indicates, that there is a substantial need for clinical VILI research in older children.

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An Assessment of Publication Status of Pediatric Liver Transplantation Studies

Cited by 9 publications

References 12 publications

Unpublished clinical studies in pediatric emergence delirium – a cross sectional analysis

Unpublished clinical studies in pediatric emergence delirium – a cross sectional analysis

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

Cross-sectional analysis on publication status and age representation of clinical studies addressing mechanical ventilation and ventilator-induced lung injury in infants and children

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