Evidence map›Paper›PMID 22529271›Full record

ArticlePediatrics2012

Clinical research involving children: registration, completeness, and publication.

Tatyana Shamliyan, Robert L Kane

Abstract read
PubMed Publisher
In one paragraph

Article in Pediatrics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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

29 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Time to publication for results of clinical trials.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Pooled it
  3. Randomized controlled trials in children's heart surgery in the 21st century: a systematic review.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2018
    Pooled it
  4. Pooled it
  5. Pooled it
  6. A systematic review of randomized controlled trials for the prevention of bronchopulmonary dysplasia in infants.Journal of perinatology : official journal of the California Perinatal Association · 2014
    Pooled it
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Congenital heart surgery avidly awaits evidence.Indian journal of thoracic and cardiovascular surgery · 2021
    Article
  14. Observational
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors.

Tatyana ShamliyanDivision of Health Policy and Management, School of Public Health, University of Minnesota, Minneapolis, Minnesota 55455, USA. shaml005@umn.edu
Robert L Kane

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveEffective health care for children must be based on thorough analyses of the best research evidence. The objective of this study was to examine registration, completeness, and publication of studies involving children.

methodsWe searched the ClinicalTrials.gov registry to identify all closed studies involving children and examined them for completeness and availability of results. We examined publication in peer-reviewed journals for 160 randomly selected National Institutes of Health (NIH)-funded studies from 2000 through 2010 and for 758 randomly selected completed studies.

resultsOf 3428 closed studies involving children identified in ClinicalTrials.gov, 2385 (70%) were completed, 28 (0.8%) suspended, 152 (4.4%) terminated, and 38 (1.1%) withdrawn. The proportion of non-completed studies (terminated and suspended) increased linearly by 186% between 2001 and 2009, from 1.9% to 8.4%. Of the 152 terminated studies, 48 did not report reasons for termination, 21 cited safety concerns, and 83 cited poor recruitment or other administrative reasons. Only 29% of completed studies were published. Publication that did occur was an average of 2 years after study completion. Completed interventional studies were published more often than observational studies. Completed industry-funded studies were published less often than studies funded by the NIH. Registered NIH-funded trials were published more often than unregistered.

conclusionsResults are unavailable for more than half of the studies involving children, revealing a substantial publication bias. Registration and posting of results on ClinicalTrials.gov should be mandatory for all studies involving children.

Indexed as

Ethics, ResearchBiomedical ResearchChildClinical Trials as TopicEarly Termination of Clinical TrialsFinancing, GovernmentFinancing, OrganizedHumansPublication BiasPublishingRegistriesUnited States

Identifiers

PMID22529271

What OpenQuestion holds

Textmetadata
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.