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Sample size estimation: an overview with applications to orthodontic clinical trial designs


Pandis, N; Polychronopoulou, A; Eliades, T (2011). Sample size estimation: an overview with applications to orthodontic clinical trial designs. American Journal of Orthodontics and Dentofacial Orthopedics, 140(4):e141-e146.

Abstract

Proper sample size estimation is an important part of clinical trial methodology and closely related to the precision and power of the trial's results. Trials with sufficient sample sizes are scientifically and ethically justified and more credible compared with trials with insufficient sizes. Planning clinical trials with inadequate sample sizes might be considered as a waste of time and resources, as well as unethical, since patients might be enrolled in a study in which the expected results will not be trusted and are unlikely to have an impact on clinical practice. Because of the low emphasis of sample size calculation in clinical trials in orthodontics, it is the objective of this article to introduce the orthodontic clinician to the importance and the general principles of sample size calculations for randomized controlled trials to serve as guidance for study designs and as a tool for quality assessment when reviewing published clinical trials in our specialty. Examples of calculations are shown for 2-arm parallel trials applicable to orthodontics. The working examples are analyzed, and the implications of design or inherent complexities in each category are discussed.

Proper sample size estimation is an important part of clinical trial methodology and closely related to the precision and power of the trial's results. Trials with sufficient sample sizes are scientifically and ethically justified and more credible compared with trials with insufficient sizes. Planning clinical trials with inadequate sample sizes might be considered as a waste of time and resources, as well as unethical, since patients might be enrolled in a study in which the expected results will not be trusted and are unlikely to have an impact on clinical practice. Because of the low emphasis of sample size calculation in clinical trials in orthodontics, it is the objective of this article to introduce the orthodontic clinician to the importance and the general principles of sample size calculations for randomized controlled trials to serve as guidance for study designs and as a tool for quality assessment when reviewing published clinical trials in our specialty. Examples of calculations are shown for 2-arm parallel trials applicable to orthodontics. The working examples are analyzed, and the implications of design or inherent complexities in each category are discussed.

Citations

3 citations in Web of Science®
9 citations in Scopus®
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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Center for Dental Medicine > Clinic for Orthodontics and Pediatric Dentistry
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2011
Deposited On:23 Feb 2012 08:18
Last Modified:05 Apr 2016 15:41
Publisher:Elsevier
ISSN:0889-5406
Publisher DOI:https://doi.org/10.1016/j.ajodo.2011.04.021
PubMed ID:21967951

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