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. 2011 Jul;26(7):783-90.
doi: 10.1007/s11606-010-1629-x. Epub 2011 Feb 1.

Examining the evidence: a systematic review of the inclusion and analysis of older adults in randomized controlled trials

Donna M Zulman  1 , Jeremy B Sussman, Xisui Chen, Christine T Cigolle, Caroline S Blaum, Rodney A Hayward
Affiliations

Examining the evidence: a systematic review of the inclusion and analysis of older adults in randomized controlled trials

Donna M Zulman et al. J Gen Intern Med. 2011 Jul.

Abstract

Background: Due to a shortage of studies focusing on older adults, clinicians and policy makers frequently rely on clinical trials of the general population to provide supportive evidence for treating complex, older patients.

Objectives: To examine the inclusion and analysis of complex, older adults in randomized controlled trials.

Review methods: A PubMed search identified phase III or IV randomized controlled trials published in 2007 in JAMA, NEJM, Lancet, Circulation, and BMJ. Therapeutic interventions that assessed major morbidity or mortality in adults were included. For each study, age eligibility, average age of study population, primary and secondary outcomes, exclusion criteria, and the frequency, characteristics, and methodology of age-specific subgroup analyses were reviewed.

Results: Of the 109 clinical trials reviewed in full, 22 (20.2%) excluded patients above a specified age. Almost half (45.6%) of the remaining trials excluded individuals using criteria that could disproportionately impact older adults. Only one in four trials (26.6%) examined outcomes that are considered highly relevant to older adults, such as health status or quality of life. Of the 42 (38.5%) trials that performed an age-specific subgroup analysis, fewer than half examined potential confounders of differential treatment effects by age, such as comorbidities or risk of primary outcome. Trials with age-specific subgroup analyses were more likely than those without to be multicenter trials (97.6% vs. 79.1%, p < 0.01) and funded by industry (83.3% vs. 62.7%, p < 0.05). Differential benefit by age was found in seven trials (16.7%).

Conclusion: Clinical trial evidence guiding treatment of complex, older adults could be improved by eliminating upper age limits for study inclusion, by reducing the use of eligibility criteria that disproportionately affect multimorbid older patients, by evaluating outcomes that are highly relevant to older individuals, and by encouraging adherence to recommended analytic methods for evaluating differential treatment effects by age.

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Figures

Figure 1
Figure 1
Study selection process.
See this image and copyright information in PMC

Comment in

  • Inclusion and analysis of older adults in RCTs.
    Van de Water W, Bastiaannet E, Van de Velde CJ, Liefers GJ. Van de Water W, et al. J Gen Intern Med. 2011 Aug;26(8):831; author reply 832. doi: 10.1007/s11606-011-1705-x. J Gen Intern Med. 2011. PMID: 21503814 Free PMC article. No abstract available.

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