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

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 potenti...

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Autores principales: Despina Koletsi, Padhraig S Fleming, Jadbinder Seehra, Pantelis G Bagos, Nikolaos Pandis
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Publicado: Public Library of Science (PLoS) 2014
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Acceso en línea:https://doaj.org/article/dae66475a7674abb9cd915572307ae74
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spelling oai:doaj.org-article:dae66475a7674abb9cd915572307ae742021-11-18T08:36:54ZAre sample sizes clear and justified in RCTs published in dental journals?1932-620310.1371/journal.pone.0085949https://doaj.org/article/dae66475a7674abb9cd915572307ae742014-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24465806/?tool=EBIhttps://doaj.org/toc/1932-6203Sample 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.Despina KoletsiPadhraig S FlemingJadbinder SeehraPantelis G BagosNikolaos PandisPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 9, Iss 1, p e85949 (2014)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Despina Koletsi
Padhraig S Fleming
Jadbinder Seehra
Pantelis G Bagos
Nikolaos Pandis
Are sample sizes clear and justified in RCTs published in dental journals?
description 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.
format article
author Despina Koletsi
Padhraig S Fleming
Jadbinder Seehra
Pantelis G Bagos
Nikolaos Pandis
author_facet Despina Koletsi
Padhraig S Fleming
Jadbinder Seehra
Pantelis G Bagos
Nikolaos Pandis
author_sort Despina Koletsi
title Are sample sizes clear and justified in RCTs published in dental journals?
title_short Are sample sizes clear and justified in RCTs published in dental journals?
title_full Are sample sizes clear and justified in RCTs published in dental journals?
title_fullStr Are sample sizes clear and justified in RCTs published in dental journals?
title_full_unstemmed Are sample sizes clear and justified in RCTs published in dental journals?
title_sort are sample sizes clear and justified in rcts published in dental journals?
publisher Public Library of Science (PLoS)
publishDate 2014
url https://doaj.org/article/dae66475a7674abb9cd915572307ae74
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