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Andrew W Murphy, Professor and Head of Department Department of General Practice, Clinical Sciences Institute, NUI, Galway, Ireland, Byrne Mary
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Dear Professor Delaney We were very interested to read the paper by Rowlands et al regarding the importance of modelling in randomised controlled trials for complex interventions in primary care(1). We are presently conducting a randomised control trial on the secondary prevention of cardiac disease in general practice (http://www.controlled-trials.com/isrctn/; ISRCTN24081411) and have, as described in the paper, developed our intervention using the MRC framework(2). Like Rowlands et al, we found the template to be very useful. Our study involves two healthcare systems – those of the United Kingdom and of Ireland – and the model was especially useful in ensuring generalisability. However, we wish to make two additional comments. Firstly, the extent and time commitment required of the exploratory study cannot be over emphasised. Rowlands et al performed a pilot study in only one general practice and highlight the subsequent difficulties which ensued due to this. We performed a pilot study in four practices – two in each healthcare system; additional practices would have been welcome. We had time-tabled this work for one year - eighteen months was required. This, we believe, was well worthwhile with high quality information gained which specifically fed into the main study design. Finally, we would disagree somewhat with Rowlands et al regarding the determination of appropriate outcomes. Surely the outcomes should be determined by the original hypotheses rather than preliminary findings? An old Irish saying is that ‘ní bhféidir muc a raimhrú trí é mheá’ (you cannot make a pig grow by weighing him). As researchers, it is important that we do not become involved in repeated weighing ! Yours sincerely Prof AW Murphy and Dr Mary Byrne Department of General Practice NUI, Galway Ireland 1 Rowlands G, Simms J, Kerry S. A Lesson Learnt: The importance of modelling in randomised controlled trials for complex interventions in primary are. Family Practice, 2005; 22: 132-9. 2 Medical Research Council. A Framework for Development and Evaluation of RCTs for Complex Interventions to Improve Health. London: Medical Research Council; 2000. Conflict of Interest:None declared |
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