How Can We Make Biomedical Studies More Inclusive?

Even in 2011, persons with disabilities (more than 47 million Americans)
are still “ profoundly underrepresented in mainstream health research”. In their recent article, the researchers Ann Williams and Shirley Moore propose a “Universal Design of Research” (UDR), which allows “routine inclusion of persons with disabilities in studies, without the need for adaptation or specialized design.”

They offer a few guidelines and ideas to support researchers in designing materials in accessible formats. Some good food for thought as the new UCSF Participant Recruitment Service (PRS) takes shape. Here is what they propose:

… provide multisensory, flexible options for recruitment, research instruments (such as questionnaires), measurements, and responses from participants, with reasonable accommodations that invite and facilitate participation by persons with disabilities; and when you do not know how to include someone with a disability, consult someone who does (the potential research participant, another person with that disability who is knowledgeable about the range of methods people use for living fully with it, or a professional who works with persons who have that disability). 

Practical guidelines for implementing the Universal Design of Research include:

… (i) plan multiple options for people to learn about, respond to, and arrive at opportunities to participate in research; (ii) provide multiple means to communicate the information in research instruments and instructions for participants; and (iii) provide multiple means of responding to research instruments and self-management interventions.

I wonder what our PRS team thinks about these ideas. And, do we know of other successful approaches, web-based technologies or great examples we could share?  Ann Williams and Shirley Moore are looking for ideas to develop comprehensive guidelines.

2 thoughts on “How Can We Make Biomedical Studies More Inclusive?

  1. This is an interesting and challenging topic. To begin with, I don’t remember ever seeing a protocol that explicitly excluded individuals with disabilities. Of course, it’s entirely possible that these subjects were excluded by sites on the basis of a general exclusion category, such as “Patient is unable or unwilling to perform all of the procedures in the protocol”. The truth is, clinical investigators probably make many decisions to exclude (or include) patients that might not be in the best interest of a broader population.

    Off the top of my head, I can think of two reasons why this happens:

    1) Sites are generally trying to recruit patients as quickly as possible, and they would like to have as few barriers as possible once the patient is in the study. As this article references, there may be a perceived notion that patients with disabilities will require more time and effort by the site staff.

    2) Any changes (or accommodations) to the data collection forms would need to be approved by an IRB. Again, this requires extra effort by both the site and the sponsor.

    I’m sure that there are other reasons as well.

    Although we’d like to think that patients in a clinical study represent a valid cross-section of the population, the reality tends to be different. One study that I worked on ended up not meeting it’s clinical target because the patients who entered the trial tended to be students (with statistically low body fat) who needed the money from participation.

    Once a drug is approved, one hopes that a broader range of data will be collected in Phase IV registry trials. But in that case, the drug is already “out there”. In Phase I, II, and III trials, it seems that speed often trumps the use of a wider patient population.

  2. One specific type of observational research is ripe for the inclusion of people with disabilities: studies using Medicare claims files or other Medicare data sets. Often researchers exclude Medicare beneficiaries under age 65 (i.e., those qualifying for Medicare because of disability; end-stage renal disease is another special category of excluded cases) without explicit justification.

    In addition to routinely gathering basic demographic data on persons experiencing events related to drugs or devices, the FDA should add information about the person’s functional status or disability. Over time, these routine data would snowball into sufficient sample sizes for meaningful statistical analyses.

    If there is a move towards pay-for-performance, what are the special protections that people with disabilities need in place to make sure that there are not perverse incentives” relating to their care? If, for example, persons with disabilities should be eliminated from certain denominators in calculating rates for performance indicators, what is to stop clinicians from gaming these numbers (e.g., excluding persons inappropriately from denominators in rate calculation.

    What is obvious is;
    •With few exceptions, little scientific evidence is available to inform development of quality indicators for persons with disabilities.
    •Hence, not surprisingly, relatively few quality measures exist specifically addressing disability-related issues.
    •Those examples that do exist focus primarily on biomedical aspects of underlying disabling conditions rather than on functioning, wellness, quality of life, and the broad range of environmental concerns

    It is undoubtedly an area where research has long way to go and which is perhaps better conducted in foreign countries.

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