Statistics Notes: Analysing controlled trials with baseline and follow up measurements

doi:10.1136/bmj.323.7321.1123

BMJ 2001;323:1123-1124 ( 10 November )

Education and debate

Statistics Notes

Analysing controlled trials with baseline and follow up measurements

Andrew J Vickers, assistant attending research methodologist ^a, Douglas G Altman, professor of statistics in medicine ^b.

^a Integrative Medicine Service, Biostatistics Service, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA, ^b ICRF Medical Statistics Group, Centre for Statistics in Medicine, Institute of Health Sciences, Oxford OX3 7LF

Correspondence to: Dr Vickers vickersa@mskcc.org
The first 150 words of the full text of this article appear below.

In many randomised trials researchers measure a continuous variable at baseline and again as an outcome assessed at followup. Baseline measurements are common in trials of chronic conditionswhere researchers want to see whether a treatment can reduce pre-existinglevels of pain, anxiety, hypertension, and thelike.

Statistical comparisons in such trials can be made in several ways. Comparison of follow up (post-treatment) scores will givea result such as "at the end of the trial, mean pain scores were15 mm (95% confidence interval 10 to 20 mm) lower in the treatmentgroup." Alternatively a change score can be calculated by subtractingthe follow up score from the baseline score, leading to a statementsuch as "pain reductions were 20 mm (16 to 24 mm) greater on treatmentthan control." If the average baseline scores are the same ineach group the estimated treatment effect will be the same usingthese two simple approaches. . . . [Full text of this article]

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