Document Type

Other

Publication Date

7-2024

Notes

ABSTRACT

Although working-age and older adults with disabilities are among the greatest beneficiaries of healthcare services, they are often excluded from clinical research that informs healthcare policy. The exclusion of people with disabilities from research may impact access to and quality of care for millions of Americans. We conducted a scoping review to examine the exclusion of working-age and older adults with disabilities from behavioral clinical trials. We aimed to explore whether exclusion criteria regarding diagnoses or health conditions associated with disability were strongly justified, poorly justified, or unjustified, as well as the distribution of the excluded health conditions by justification category. We conducted a systematic search of ClinicalTrials.gov on November 18, 2018, and an updated search on April 27, 2021. We searched for interventional behavioral studies that were conducted in the US, focused on working-age adults (18–64) and/or older adults (65+), and were completed from 2008–2020. We found 327 clinical trials that matched our criteria. Of 327 studies, 256 excluded at least one diagnosis or health condition. A total of 1342 exclusion criteria related to diagnoses or health conditions were listed, 76.3% of which were unjustified. Our findings provide strong evidence that people with disabilities are excluded from behavioral clinical trials, often with no or poor justification. Results support the need to develop strategies, such as including disability as a demographic variable, to minimize the exclusion of people with disabilities when the population is part of a group to which study results are generalized. When exclusion of health conditions is necessary, a clear justification should be provided.

FUNDING

The contents of this report were developed under a grant from the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR grant number 90DPCP0001). NIDILRR is a center within the Administration for Community Living (ACL), Department of Health and Human Services (HHS). The contents of this report do not necessarily represent the policies of NIDILRR, ACL, or HHS, and endorsement by the Federal Government should not be assumed.

ORCID iD

Szu-Wei Chen (0000-0002-9630-0934) - ORCID

Sandra Martina Espín Tello (0000-0002-0235-3104) - ORCID

Audrey Keleman (0000-0003-1025-3100) - ORCID

Rebecca Bollinger (0000-0002-1931-8372) - ORCID

Jessica Dashner (0000-0002-0415-3691) - ORCID

Megen Devine (0000-0003-3279-1110) - ORCID

Susan Stark (0000-0002-2816-7158) - ORCID

Download

Share

COinS