The demise of a planned randomised controlled trial in an urban Aboriginal medical service

To the Editor: Jamrozik's editorial1 about our report of a failed randomised controlled trial (RCT)2 in an Aboriginal medical service helps to explain why researchers might be reluctant to submit articles describing unsuccessful trials, thus limiting potential for the scientific community to learn from such experiences. The main point of our article was to describe the manifest difficulties of implementing an RCT — the evidence "gold standard" — in this type of setting. Interestingly, Jamrozik largely attributes these difficulties to incompetence or naivety (or both) on the part of the researchers and funders, rather than to complexities inherent in the study design, the setting and the intervention.

A separately funded pilot study is, in principle, a good idea, but extremely difficult to get funding for in today's environment. Of course, we did conduct a pilot — that, in fact, was what we reported on — but it is unclear how this would have helped us better estimate absolute prevalences and effect sizes for intervention and control groups, as a substantial number of participants, followed up for six months, would have been needed to do this.

Nor is it clear how taking a population approach and distributing guidelines to all drinkers rather than offering personalised advice to hazardous drinkers would have helped — firstly, because we were specifically trialling the internationally validated brief intervention, and secondly, because the effect size of the alternative approach would have been so small that we would have needed very much larger numbers to test its effectiveness. We had no intention of "stumbling down something like this path".

Nor do we agree that the blood tests were "medicalising a social problem". They were intended not only to provide robust outcome measures (a mark of a good trial), but also tangible evidence to clients of the health effects of alcohol, shown from previous research to be well received by Aboriginal people.3,4 They were not a requirement for participation.

Further, that we should have got around the potentially off-putting business of seeking informed consent by bypassing this step almost defies comment. While trials of some therapeutic interventions can be undertaken blind with patient consent by using placebos, this does not mean that where blinding is not possible patient consent should be done away with in order to avoid a Hawthorne effect!

However, we do agree with Jamrozik on one point — nothing about this study or our report could reasonably "compound any negative perceptions about Aboriginal Medical Services and Aboriginal patients".1