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BMJ No 7115 Volume 315 Papers Saturday 25 October 1997
Exclusion of elderly people from clinical research: a descriptive study of published reportsG Bugeja, A Kumar, Arup K Banerjee See Editorial by Avorn, p 1033 Conclusions reached in studies of young people cannot be extrapolated to elderly people.(1) It is thus essential that elderly people are included in clinical studies. We set out to discover whether and to what extent studies published in medical journals exclude this section of the population. Methods and resultsWe examined all the original research papers in all the issues of the BMJ, Gut, the Lancet, and Thorax between 1 June 1996 and 1 June 1997. We excluded case studies and meta-analyses. We looked for a mention of age limit first in the abstract or the methods section of the papers, but we sometimes found it mentioned in other parts of the papers instead. We then categorised the papers as studies (a) specifically of elderly people (aged 75 years or more); (b) excluding elderly people for justifiable reasons (where long follow up was planned); (c) excluding elderly people with no justifiable reasons; and (d) not setting an age limit. We excluded papers that were concerned with children and adolescents; pregnancy and reproduction; sexually transmitted diseases; animal work; cell and tissue studies; or employment related research. The results are given in the table. We found 1,012 papers and excluded 522. Of the remaining 490 papers, 18 were specifically about elderly people, 37 excluded the elderly for justifiable reasons, 170 excluded them unjustifiably, and in 265 no age limit was set.
CommentA third of the original research papers in major medical journals excluded elderly people without justification. Although the journals were not selected randomly and we included a small number of papers published within a short period of time, we believe that our findings are important and relevant to current practice and behaviour in clinical research. Elderly people may be excluded from clinical research for many reasons.
Often the decision to participate in research cannot be taken by the
elderly person alone. Family members and caregivers take part in the
decision to participate in the study, and the investigator has to
establish rapport with both the patient and family members. This is
usually a time consuming and complicated task. Many investigators may
avoid these problems by excluding elderly people from their
study.(2) Or they may exclude them because they fear that
frailty and comorbid conditions may put e Applying the results of research that excluded e
Department of Medicine for the Elderly,
Correspondence to: Dr
Banerjee
Funding: None.
Conflicts of interest: None.
(Accepted 7 October 1997)
References
1 Bell J A, May F E, Stewart R B. Clinical research in the
elderly: ethical and methodological considerations. Drug Intell
Clin Pharm 1987;21:1002-7.
2 Williams S G. Research considerations: family opinions about
elderly relatives in research. J Gerontol Nurs
1992;18(12):3-8.
3 Monfardini S, Sorio R, Boes G H, Kaye S, Serraino D. Entry and
evaluation of elderly patients in European Organization for Research
and Treatment of Cancer (EORTC) new drug-development studies.
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