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- Title
Nonpublication and discontinuation of randomised controlled trials in newborns.
- Authors
Rüegger, Christoph M.; Dawson, Jennifer A.; Donath, Susan M.; Owen, Louise S.; Davis, Peter G.
- Abstract
<bold>Aim: </bold>To determine the rate of nonpublication and discontinuation of randomised controlled trials (RCTs) in newborns.<bold>Methods: </bold>This was a retrospective, cross-sectional study of RCTs registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR) between 2008 and 2012.<bold>Results: </bold>Fifty trials were identified, of which 23 (46%) were retrospectively registered. Thirty trials (60%) were published. After a median follow-up of 8.0 (range 4.6-17.4) years from Research Ethics Committee approval, 15 of 41 completed trials (37%) remained unpublished, representing 5422 neonatal trial participants. Nine trials (18%) were discontinued, including four that were published. The most frequent reason for discontinuation was poor recruitment (n = 4). Sample size discrepancies between registration and publication were found in 17 (65%) of the 26 completed, published trials. In nine (35%) of these trials, the calculated sample size in the method section of the published article differed from the planned sample size in the trial registry (relative difference -20% to +33%).<bold>Conclusion: </bold>Nonpublication and discontinuation of RCTs conducted in newborns is common. Additional efforts are needed to minimise the number of neonatal trial participants that are exposed to interventions without subsequent publication.
- Subjects
AUSTRALIA; NEW Zealand; NEWBORN infants; RANDOMIZED controlled trials; SCIENCE publishing; PATIENT selection; SAMPLE size (Statistics); CLINICAL trials; PUBLISHING; SYSTEMATIC reviews; CROSS-sectional method; RETROSPECTIVE studies
- Publication
Acta Paediatrica, 2017, Vol 106, Issue 12, p1940
- ISSN
0803-5253
- Publication type
journal article
- DOI
10.1111/apa.14062