Philpot et al have done no more than reiterate (albeit in more detail) what we have already described and discussed in the paper.1 The study design as outlined in the methods clearly states that the Fremantle Primary Prevention Study was ‘an open, prospective, pragmatic2 randomised study in three practices’ involving 1200 participants with the aim of absolute cardiovascular risk reduction.
We sought to examine our intervention in the real life situation of busy clinical practices. We clearly stated that the study designated five visits for the intensive group and two for the opportunistic group and for ethical reasons we placed no restrictions on routine attendances outside of planned study visits. We have no information on whether or not relative risk cardiovascular targets were discussed at unplanned visits. It is possible that the impact of the intervention on absolute risk reduction could have been more marked if visits were restricted.
Time constraints inevitably impact on busy GPs and practice nurses in clinical practice and need to be taken into account in the design of research studies. In our study, ethical practice necessitated that clinical judgements on the efficacy of introducing or altering pharmacological treatment, referrals to a dietician, exercise physiologist, or cardiologist, were at the discretion of the treating doctor. The practice nurses played key roles in recruitment, randomisation, and follow-up of participants.3 Whether health promotion messages are effective or not would depend on who delivers the messages and how they are delivered.
Effective translational research in a general practice setting requires a pragmatic approach which inevitably leads to complexity of study design. We were pleased that so many patients engaged in the study and follow-up discussions suggest their enablement benefitted from the experience.
All research can be improved as none is perfect.
- © British Journal of General Practice 2012