Background: Participants in randomised controlled trials (RCTs) for secondary stroke may not reflect the broader stroke population due to exclusion criteria or lack of willingness to participate. The TIIPS RCT assessed the effectiveness of health coaching for secondary stroke prevention. We aimed to compare the sociodemographic profile of those who declined or were ineligible with the randomised group.
Methods: We recruited 326 adults aged ≥18 years with recent TIA/minor stroke from public hospitals in New Zealand. Exclusion criteria included: systolic blood pressure < 120 mmHg, not fluent in English, significant comorbidities, alcohol/drug abuse, and cognitive impairment. Descriptive comparisons were conducted between the randomised and non-randomised groups.
Results: Of the 1197 who were potentially eligible, 41% declined at first contact, 14% were ineligible before consent, and 18% were ineligible post-consent at screening. The randomised group contained more males (60%), older participants - average age 68 [SD 10.7] and Europeans (80%). Only 11% of participants were under 54. In contrast the non-randomised group had 54% males, was younger (mean age 65 [SD 12.6]) and had a greater proportion of non-European ethnicities (36% Māori, Pacific, and Asian compared to 19% in the randomised group). Māori and Pacific people were also more likely to decline participation.
Conclusion: Participants willing and eligible for secondary stroke prevention RCTs were more likely to be older Europeans. Māori and Pacific peoples, who often experience stroke at younger ages, were underrepresented. These findings highlight the need for culturally responsive recruitment strategies to ensure equitable representation in stroke prevention RCTS.