Recruiting equal numbers of indigenous and non-indigenous participants to a ‘polypill’ randomized trialReportar como inadecuado

Recruiting equal numbers of indigenous and non-indigenous participants to a ‘polypill’ randomized trial - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

International Journal for Equity in Health

, 12:44

First Online: 22 June 2013Received: 10 February 2013Accepted: 18 June 2013DOI: 10.1186-1475-9276-12-44

Cite this article as: Selak, V., Crengle, S., Elley, C.R. et al. Int J Equity Health 2013 12: 44. doi:10.1186-1475-9276-12-44


IntroductionMāori are disproportionately affected by cardiovascular disease CVD, which is the main reason for the eight year difference in life expectancy between Māori and non-Māori. The primary care-based IMPACT IMProving Adherence using Combination Therapy trial evaluates whether fixed dose combination therapy a -polypill- improves adherence to guideline-based therapy compared with current care among people at high risk of CVD. Interventions shown in trials to be effective do not necessarily reduce ethnic disparities, and may in fact widen them. Indigenous populations with poorer health outcomes are often under-represented in trials so the effect of interventions cannot be assessed for them, specifically. Therefore, the IMPACT trial aimed to recruit as many Māori as non-Māori to assess the consistency of the effect of the polypill. This paper describes the methods and results of the recruitment strategy used to achieve this.

MethodsExperienced Māori researchers were involved in trial governance throughout trial development and conduct. The trial Steering Committee included leading Māori researchers and was committed to equal recruitment of Māori and non-Māori. Additional funding and Māori research nurses were sought to allow home-based assessment, establishment of the relationship between research nurse and participant, more family involvement prior to enrollment, continuity of the research nurse-participant relationship, and acknowledgement of other Māori culturally important procedures, interactions, language and manners. Primary care practices with high enrollment of Māori were targeted, with over-sampling of potentially eligible Māori patients, lower thresholds for screening of Māori and 6 months continued Māori recruitment after non-Māori recruitment had finished.

ResultsA total of 257 Māori and 256 non-Māori participants were randomized. Four Māori and eight non-Māori participants were randomized per research nurse per month. Potentially eligible Māori were more likely than non-Māori to proceed to subsequent stages of recruitment. Differences between randomized Māori and non-Māori were evident e.g. Maori were less likely to have established coronary artery disease.

ConclusionsRecruitment of equal numbers of indigenous and non-indigenous participants is possible if it is prioritised, adequately resourced and self-determination is supported.

Trial registrationThe trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN12606000067572

KeywordsInequalities Cardiovascular disease Indigenous Polypill Primary care Randomized controlled trial Electronic supplementary materialThe online version of this article doi:10.1186-1475-9276-12-44 contains supplementary material, which is available to authorized users.

Download fulltext PDF

Autor: Vanessa Selak - Sue Crengle - C Raina Elley - Angela Wadham - Matire Harwood - Natasha Rafter - Chris Bullen - Avinesh Pi


Documentos relacionados