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Baseline data in clinical trials
Author(s) -
Burgess David C,
Gebski Val J,
Keech Anthony C
Publication year - 2003
Publication title -
medical journal of australia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 131
eISSN - 1326-5377
pISSN - 0025-729X
DOI - 10.5694/j.1326-5377.2003.tb05447.x
Subject(s) - clinical trial , medicine , principal (computer security) , library science , computer science , operating system
The Medical Journal of Australia ISSN: 0025-729X 21 July 2003 179 2 105-107 ©The Medical Journal of Australia 2003 www.mja.com.au EBM: Trials On Trial ALTHOUGH REPORTING BASELINE DATA seems simple, it is crucial information for readers in judging the validity of a trial. Knowing the baseline characteristics of the trial participants allows readers to assess how closely these match patients seen in their own clinical practice, and therefore how generalisable the results of the trial will be (so-called external validity). Baseline characteristics also allow the success of randomisation to be assessed. In studies where important baseline factors appear well balanced, it is likely that any differences in outcome between the intervention and control groups are a real effect of treatment (one component of internal validity). For these reasons, the reporting of baseline demographic and clinical characteristics of each group is a requirement of the CONSORT statement.1 The item and its descriptor as they appear in the CONSORT checklist are shown in Box 1, and a checklist for baseline data is provided in Box 2.