Published in:
Open Access
01-08-2011 | Letters
Inclusion and Analysis of Older Adults in RCTs
Authors:
W. Van de Water, MD, E. Bastiaannet, MSc, C. J. H. Van de Velde, MD, PhD, G. J. Liefers, MD PhD
Published in:
Journal of General Internal Medicine
|
Issue 8/2011
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Excerpt
To the Editor:—We read with interest the paper of Zulman et al. regarding the inclusion and analysis of older adults in randomized controlled trials
1. In a detailed cohort study of over 1500 breast cancer patients aged 65 years and older, we applied the inclusion and exclusion criteria of the clinical trials upon which the national breast cancer guidelines in The Netherlands are founded. Based on age, 43% of the patients would be excluded. Of the remaining patients, 25% would be ineligible due to comorbid conditions and 12% because of a history of cancer. After exclusion criteria regarding breast cancer stage, a maximum of 12% of elderly patients could enter the trials. Consequently, studies which do include elderly are likely to suffer from selection bias; only elderly patients considered ‘healthy enough’ will enter
2. Extrapolation of results of many clinical trials to the elderly population therefore is at least questionable. …
