Evidence map›Paper›PMID 30455388›Full record

ArticleBMJ open2018

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

Christian Patry, Simon Kranig, Neysan Rafat, Thomas Schaible, Burkhard Toenshoff, Georg F Hoffmann, Markus Ries

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Time to publication for results of clinical trials.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Christian Patry *Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.ORCID 0000-0002-1270-6508
Simon Kranig *Department of Neonatology, University Children's Hospital Heidelberg, Heidelberg, Germany.
Neysan RafatClinic for Neonatology, University Medical Center Mannheim, Mannheim, Germany.
Thomas SchaibleClinic for Neonatology, University Medical Center Mannheim, Mannheim, Germany.
Burkhard ToenshoffDepartment of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.
Georg F HoffmannDepartment of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.
Markus RiesPediatric Neurology and Metabolic Medicine, Center for Pediatric and Adolescent Medicine, University Hospital Heidelberg, Heidelberg, Germany.ORCID 0000-0002-5054-5741
Heidelberg University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 MEASURES: Assessment, 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.

Indexed as

Bronchopulmonary DysplasiaRespiration, ArtificialVentilator-Induced Lung InjuryAdolescentBiomedical ResearchChildChild, PreschoolCross-Sectional StudiesEvidence-Based MedicineHumansInfantInfant, NewbornPublication BiasPublishingRespiratory Insufficiencyevidence-based medicinemechanical ventilationpediatricspublication biasresearch ethicsventilator induced lung injury

Identifiers

PMID30455388
PMCPMC6252714
OpenAlexW2901282493

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.