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Facilitators and barriers to implementation of a pragmatic clinical trial in Aboriginal health services

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The principles of conducting ethically sound health research involving Aboriginal and Torres Strait Islander peoples have been well documented.13 There are, however, many challenges to implementation of these principles and negative experiences have been reported.411 A key element to the National Health and Medical Research Council (NHMRC) guidelines for ethical conduct in Aboriginal and Torres Strait Islander health research is the notion of reciprocity — that the benefits of the research be clearly articulated, negotiated and implemented in such a way that it will build community capacity.1 In the context of clinical trials, this includes ensuring that studies test interventions in the settings in which they will eventually be delivered, rather than contrived environments that are conducive to easier trial implementation. Such trials are often referred to as pragmatic randomised controlled trials (PRCTs).12

The Kanyini Guidelines with the Adherence Polypill (KGAP) study was a PRCT that tested whether a polypill-based strategy would improve prescriber and patient adherence to recommended treatments for cardiovascular disease (CVD).13