An important study in the Journal of General Internal Medicine shows these examples are not isolated incidents. Rather, the failure to make clinical research relevant to most older patients is a deeply embedded, pervasive, and systemic problem. Things really need to change.
The investigators, led by Dr. Donna Zulman at the University of Michigan, reviewed over 100 studies of theraputic interventions for diseases that are common in older persons. They focused on studies published in the most widely read and influential medical journals. They analyzed these studies to evaluate their relevance to the typical older patient. Here are the rather distressing findings:
- 20% of studies automatically excluded patients above a specific age
- An additional 46% of studies had exclusion criteria that would inevitably result in the disproportionate exclusion of older patients (including decreased life expectancy, functional limitations, comorbid illness)
- 40% of studies did not bother to report the age range of subjects
- Only 27% of studies measured outcomes of particular relevance to older patients such as quality of life or functional status
- Only 39% of studies examined whether treatment results were different in younger and older patients.
- Research studying diseases common in older patients should not exclude subjects based solely on age
- Eligibility criteria that disproportionately exclude older patients should be minimized. For example, exclusions based on comorbid disease and functional status should be avoided. A useful guideline is that if the patient would be a candidate for the treatment, they are a candidate for the study. It is not appropriate to exclude subjects to make the study easier.
- Studies of diseases that are common in older patients should examine the impact of treatments on functional status and quality of life
- Surveillance for adverse effects should include problems of special concerns in older persons such as falls
- Research procedure should be modified to allow inclusion of frail patients (for example, providing transportation, home visits)
- Characteristics of older patients should be described in detail--including detailed description of age ranges, as well as descriptions of the functional and cognitive status
It is time to for funders like the NIH and regulators like the FDA to insist that studies of problems common in older persons are actually relevant to older patients. As previously discussed on GeriPal, the NIH should start this process by requiring all research it funds to describe how it will assure relevance to older populations.
Things really need to change.
by Ken Covinsky