Sample size calculations for pilot randomized trials: a confidence interval approach

被引:318
作者
Cocks, Kim [1 ]
Torgerson, David J. [1 ]
机构
[1] Univ York, Dept Hlth Sci, York Trials Unit, York YO10 5DD, N Yorkshire, England
关键词
Sample size; Pilot trials; Confidence intervals; Statistical power; Review; Randomised trials; EFFICIENCY; POWER;
D O I
10.1016/j.jclinepi.2012.09.002
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
100404 [儿少卫生与妇幼保健学];
摘要
Objectives: To describe a method using confidence intervals (CIs) to estimate the sample size for a pilot randomized trial. Study Design: Using one-sided CIs and the estimated effect size that would be sought in a large trial, we calculated the sample size needed for pilot trials. Results: Using an 80% one-sided CI, we estimated that a pilot trial should have at least 9% of the sample size of the main planned trial. Conclusion: Using the estimated effect size difference for the main trial and using a one-sided CI, this allows us to calculate a sample size for a pilot trial, which will make its results more useful than at present. (C) 2013 Elsevier Inc. All rights reserved.
引用
收藏
页码:197 / 201
页数:5
相关论文
共 14 条
[1]
What is a pilot or feasibility study? A review of current practice and editorial policy [J].
Arain, Mubashir ;
Campbell, Michael J. ;
Cooper, Cindy L. ;
Lancaster, Gillian A. .
BMC MEDICAL RESEARCH METHODOLOGY, 2010, 10
[2]
INTERNAL PILOT-STUDIES FOR ESTIMATING SAMPLE-SIZE [J].
BIRKETT, MA ;
DAY, SJ .
STATISTICS IN MEDICINE, 1994, 13 (23-24) :2455-2463
[3]
The tyranny of power: is there a better way to calculate sample size? [J].
Bland, John Martin .
BMJ-BRITISH MEDICAL JOURNAL, 2009, 339 :1133-1135
[4]
ON THE USE OF A PILOT SAMPLE FOR SAMPLE-SIZE DETERMINATION [J].
BROWNE, RH .
STATISTICS IN MEDICINE, 1995, 14 (17) :1933-1940
[5]
Cox Helen, 2010, Complement Ther Clin Pract, V16, P76, DOI 10.1016/j.ctcp.2009.09.010
[6]
POWER AND SAMPLE-SIZE CALCULATIONS - A REVIEW AND COMPUTER-PROGRAM [J].
DUPONT, WD ;
PLUMMER, WD .
CONTROLLED CLINICAL TRIALS, 1990, 11 (02) :116-128
[7]
Sample size of 12 per group rule of thumb for a pilot study [J].
Julious, SA .
PHARMACEUTICAL STATISTICS, 2005, 4 (04) :287-291
[8]
Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses [J].
Kjaergard, LL ;
Villumsen, J ;
Gluud, C .
ANNALS OF INTERNAL MEDICINE, 2001, 135 (11) :982-989
[9]
The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency [J].
Sim, Julius ;
Lewis, Martyn .
JOURNAL OF CLINICAL EPIDEMIOLOGY, 2012, 65 (03) :301-308
[10]
Smithson M., 2003, Confidence Intervals