How to reduce the number of patients needed for randomized trials: A basic introduction Journal Article


Author: Vickers, A.
Article Title: How to reduce the number of patients needed for randomized trials: A basic introduction
Abstract: Complementary therapies are often used to treat patients with persisting conditions. In a typical randomized trial, patients are assessed for symptom severity at baseline, randomized to treatment or control and then reassessed after a suitable follow-up period. It can be shown that the number of patients required for such trials can be reduced by the use of two methods: repeat measurement and analysis of co-variance (ANCOVA). An example is given of a trial of acupuncture for back pain. Administering the pain questionnaire twice at baseline and four times at follow-up reduces the number of patients by approximately 20% compared to single questionnaire administration. Use of ANCOVA decreases the number of patients by approximately a further 10%. There are considerable economic and ethical advantages to reducing sample size by a third; however, ANCOVA is statistically complex and expert statistical help is required. © 2002 Elsevier Science Ltd. All rights reserved.
Keywords: controlled study; clinical trial; patient selection; follow up; controlled clinical trial; randomized controlled trial; medical assessment; backache; questionnaire; disease severity; statistical analysis; randomized controlled trials; alternative medicine; acupuncture; symptomatology; pain measurement; analysis of variance; medical ethics; pain assessment; economic aspect; sample size; acupuncture therapy; back pain; analysis of covariance; humans; human; article
Journal Title: Complementary Therapies in Medicine
Volume: 9
Issue: 4
ISSN: 0965-2299
Publisher: Elsevier Inc.  
Date Published: 2001-12-01
Start Page: 234
End Page: 236
Language: English
DOI: 10.1054/ctim.2001.0467
PUBMED: 12184352
PROVIDER: scopus
DOI/URL:
Notes: Export Date: 21 May 2015 -- Source: Scopus
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  1. Andrew J Vickers
    880 Vickers