Monday, August 8, 2011

The (Ir)Relevance of Medical Research to Older Patients

Research studies often are conducted as if older patient's don't exist. Even when the disease being studied predominantly effects older persons, the study includes patients that bear little resemblence to the typical older patient. This makes providing the best care for older patients difficult because we have little evidence to inform best care practices. We have discussed several specific examples of this problem on GeriPal (see here, here, and here).

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.
Zulman and her team make a number of useful suggestions that should guide future studies:

  • 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

4 comments:

Accunurse said...

Thanks for sharing this, this issue really needs to be addressed, especially as the elderly population grows.

Christopher Langston said...

I've been toying with the argument that disparities in health care due to age should be considered just like those due to race.

I don't know if that would actually get more older persons included in trials. I don't know if our concerns about racial disparities results in appropriate inclusion either.

But, I think it would add a moral imparative to the issue that might help people understand.

ken covinsky said...

Chris--the disparities idea is interesting. It is perhaps not the usual disparities arguement in that it is often correct to provide different care to older patients than younger patients. This is in part of why representing older persons in clinical research is so important. The assumption that works for younger patients will work for older patients can be hazardous.

Yet, from a social justice point of view, the disparities approach is right on. The systematic exclusion of elders from clinical research is a form of ageism-and suggests elders are not viewed as that important.

It may be time for our community to put a sustained focus on encouraging the NIH to add representation of older populations to the inclusiveness criteria of grant applications. This seems to have had beneficial effects in terms of including diverse populations and women in clinical research.

While this approach might only apply to NIH funded work, its eventual impact could be greater. A declaration by the NIH that age inclusiveness is an essential component of the scientific merit of a research proposal could have more wide ranging effects on research cultures.

Alex Smith said...

I think the idea of asking the NIH to specifically require justification for inclusion or exclusion of older adults is a terrific idea.

50 years ago there were few studies that included women or people of color. That has changed for the better, perhpas in large part due to efforts to include these groups in government funded research. But no justification is required for the routine age cut-offs of most trials.