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PLoS One. 2014 Jan 21;9(1):e85949. doi: 10.1371/journal.pone.0085949. eCollection 2014.

Are sample sizes clear and justified in RCTs published in dental journals?

Author information

1
Department of Orthodontics, School of Dentistry, University of Athens and Private Practice in Athens, Greece.
2
Barts and The London School of Medicine and Dentistry, Institute of Dentistry, Queen Mary University of London, London, United Kingdom.
3
Department of Orthodontics, Kings College Hospital NHS Foundation Trust, London, United Kingdom.
4
Department of Computer Science and Biomedical Informatics, University of Thessaly, Lamia, Greece.
5
Department of Orthodontics and Dentofacial Orthopedics, Dental School/Medical Faculty, University of Bern, Switzerland and Private Practice in Corfu, Greece.

Erratum in

  • PLoS One. 2014;9(3):e85949.

Abstract

Sample size calculations are advocated by the CONSORT group to justify sample sizes in randomized controlled trials (RCTs). The aim of this study was primarily to evaluate the reporting of sample size calculations, to establish the accuracy of these calculations in dental RCTs and to explore potential predictors associated with adequate reporting. Electronic searching was undertaken in eight leading specific and general dental journals. Replication of sample size calculations was undertaken where possible. Assumed variances or odds for control and intervention groups were also compared against those observed. The relationship between parameters including journal type, number of authors, trial design, involvement of methodologist, single-/multi-center study and region and year of publication, and the accuracy of sample size reporting was assessed using univariable and multivariable logistic regression. Of 413 RCTs identified, sufficient information to allow replication of sample size calculations was provided in only 121 studies (29.3%). Recalculations demonstrated an overall median overestimation of sample size of 15.2% after provisions for losses to follow-up. There was evidence that journal, methodologist involvement (OR = 1.97, CI: 1.10, 3.53), multi-center settings (OR = 1.86, CI: 1.01, 3.43) and time since publication (OR = 1.24, CI: 1.12, 1.38) were significant predictors of adequate description of sample size assumptions. Among journals JCP had the highest odds of adequately reporting sufficient data to permit sample size recalculation, followed by AJODO and JDR, with 61% (OR = 0.39, CI: 0.19, 0.80) and 66% (OR = 0.34, CI: 0.15, 0.75) lower odds, respectively. Both assumed variances and odds were found to underestimate the observed values. Presentation of sample size calculations in the dental literature is suboptimal; incorrect assumptions may have a bearing on the power of RCTs.

PMID:
24465806
PMCID:
PMC3897561
DOI:
10.1371/journal.pone.0085949
[Indexed for MEDLINE]
Free PMC Article

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