Skip to main content

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

Comments

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

Popular posts from this blog

Practical Advice for the End of Life: A Podcast with BJ Miller

This week we talk with BJ Miller, hospice and palliative care physician, public speaker, and now author with Shoshana Berger of the book "A Beginner's Guide to the End."

As we note on the podcast, BJ is about as close as we get to a celebrity in Hospice and Palliative Care.  His TED Talk "What Really Matters at the End of Life" has been viewed more than 9 million times.  As we discuss on the Podcast, this has changed BJ's life, and he spends most of his working time engaged in public speaking, being the public "face" of the hospice and palliative care movement.

The book he and Berger wrote is filled to the brim with practical advice.  I mean, nuts and bolts practical advice.  Things like:
How to clean out not only your emotional house but your physical house (turns out there are services for that!)Posting about your illness on social media (should you post to Facebook)What is the difference between a funeral home and mortuaryCan I afford to die?  …

Improving Advance Care Planning for Latinos with Cancer: A Podcast with Fischer and Fink

In this week's GeriPal podcast we talk with Stacy Fischer, MD and Regina Fink, RN, PhD, both from the University of Colorado, about a lay health navigator intervention to improve advance care planning with Latinos with advanced cancer.  The issue of lay health navigators raises several issues that we discuss, including:
What is a lay health navigator?What do they do?  How are they trained?What do lay health navigators offer that specialized palliative care doesn't?  Are they replacing us?What makes the health navigator intervention particularly appropriate for Latinos and rural individuals?  For advance care planning? Eric and I had fun singing in French (yes French, not Spanish, listen to the podcast to learn why).
Enjoy! -@AlexSmithMD




You can also find us onYoutube!



Listen to GeriPal Podcasts on:
iTunes Google Play MusicSoundcloudStitcher

Transcript

Eric: Welcome to the GeriPal podcast. This is Eric Widera.

Alex: This is Alex Smith.

Eric: And Alex, I'm really excited about toda…

The Dangers of Fleet Enemas

The dangers of oral sodium phosphate preparations are fairly well known in the medical community. In 2006 the FDA issued it’s first warning that patients taking oral sodium phosphate preparations are at risk for potential for acute kidney injury. Two years later, over-the-counter preparations of these drugs were voluntarily withdrawn by the manufacturers.  Those agents still available by prescription were given black box warnings mainly due to acute phosphate nephropathy that can result in renal failure, especially in older adults. Despite all this talk of oral preparations, little was mentioned about a sodium phosphate preparation that is still available over-the-counter – the Fleet enema.

Why Oral Sodium Phosphate Preparations Are Dangerous 

Before we go into the risks of Fleet enemas, lets spend just a couple sentences on why oral sodium phosphate preparations carry significant risks. First, oral sodium phosphate preparations can cause significant fluid shifts within the colon …