25 Jul Who is Underrepresented in Cardiology Trials?
MedicalResearch.com Interview with:
Quoc Dinh Nguyen, MD MA MPH
Interniste-gériatre – Service de gériatrie
Centre hospitalier de l’Université de Montréal – CHUM
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Randomized trials are the best evidence basis we have to treat patients. It is known for more than 20 years that older adults and women are disproportionately excluded from randomized trials in cardiology diseases. As the current US population is fast aging, we examined whether this underrepresentation improved or worsened in the last 20 years in the most influential studies published between 1996 and 2015.
The main finding is that the women and older adults continue to be underrepresented in cardiology trials. Overall, the mean age was 63 years and the percentage of women was 29%. For coronary heart disease, women comprise 54% of the US population in need of treatment, yet are only 27% of the trial population. For heart failure, the median age of older adults in the US population is 70 years whereas it is only 64 years in the trial population.
Our results indicate that the gap has very slowly narrowed in the last 2 decades. However, based on current trends, reaching proportionate enrollment would require between 3 and 9 decades. This persistent lack of representation has significant impacts on the ability of clinicians to provide evidenced based care for these segments of the population. Physicians and other health care professionals are forced to extrapolate study results from younger and male-predominant populations. This is problematic since we know that older adults and women may react differently to medications and to interventions.
MedicalResearch.com: What should readers take away from your report?
Response: Achieving better representation is important to ensure the provision of age and sex-appropriate care for patients with cardiology diseases. Stronger regulations, reducing recruitment biases, facilitating the participation of older adults in studies may improve representation. We have to do better in the future.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: I think that future research should aim to define the best measure to capture the differential effects of an intervention according to age, comorbidities (other diseases), and frailty.
Circ Cardiovasc Qual Outcomes. 2018 Jun;11(6):e004713. doi: 10.1161/CIRCOUTCOMES.118.004713.
Nguyen QD, Peters E, Wassef A, Desmarais P, Rémillard-Labrosse D, Tremblay-Gravel M.
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