1 2 aim

#apaperaday: Barriers to diverse clinical trial participation in Duchenne muscular dystrophy: Engaging Hispanic/Latina caregivers and health professionals

In today’s #apaperaday, Prof. Aartsma-Rus reads and comments on the paper titled: Barriers to diverse clinical trial participation in Duchenne muscular dystrophy: Engaging Hispanic/Latina caregivers and health professionals

The pick is from @ojrarediseases by Crossnohere et al on barriers to clinical trial participation of Hispanic/Latina Duchenne families doi 10.1186/s13023-024-03209-7

Diversity matters in clinical trials: benefits & side effects can occur & be experienced differently due to cultural, social & genetic differences. But often minorities are underrepresented in clinical trials, eg in USA 19% is Hispanic/Latina but 11-16% of trial participants are.

For Duchenne this underrepresentation is likely even larger. Authors here explored barriers by interviewing 12 Hispanic/Latina Duchenne caregivers (all female) and 18 health care professionals (HCP). Both groups mentioned barriers across all stages of trial inclusion.

  1. Identification of participants: often families were not or less aware as most online information is in English and proficiency may be low (6 of the interviews with caregivers were done in Spanish). HCP indicate disparity in families attending the clinic. Usually these are first approached and some trial sites have lower representation of minorities.
  2. Prescreening. No English proficiency is sometimes a reason not to include a family as there are no interpreters available. Also anticipated non compliance was mentioned by HCPs. HCPs sometimes outline this may be a bias, while others worry that non compliance (eg missing check up visits) may lead to safety issues (missing side effects).
  3. Screening. Families decline participation when the burden is seen as too high (eg biopsy).HCPs mention there is a lack of trust in the healthcare system. Caregivers specify there is lack of trust with specific HCP but not the system in general. HCP also mention some families are illegally in the USA and want to stay below the radar and thus not participate. This was not mentioned by the caregivers but probably the illegal caregivers would also not want to participate in the interviews.
  4. Consent/enrollment Both caregivers and HCP mentioned logistic challenges. Time, money and resources can be prohibitive factors. When there is no English proficiency this means families need to take a family member who is more proficient to trial visits while also missing work themselves, which poses a large burden for low income families. Thus families need more time for decision making. Sometimes this leads to missing a slot as it is filled by another patient. Having Spanish trial information would be a huge help to facilitate decision making. Authors discuss the study was done only in the US & involved few Hispanic/Latino families only (recruitment was challenging).

Authors have recommendations:

  1. Translations of resources in Spanish
  2. Provide decision making tools
  3. Give more time to minorities
  4. Build trust (also during management). Listen to concerns and take them seriously.
  5. Engage more with minorities (all stakeholders).

Provide ethical screening guidelines to avoid exclusion of patients due to biases. Important paper and I appreciate that authors outlined challenges and provided recommendations.