Trials in primary care: statistical issues in the design, conduct and evaluation of complex interventions.

Trials carried out in primary care typically involve complex interventions that require considerable planning if they are to be implemented successfully. The role of the statistician in promoting both robust study design and appropriate statistical analysis is an important contribution to a multi-disciplinary primary care research group. Issues in the design of complex interventions have been addressed in the Medical Research Council's new guidance document and over the past 7 years by the Royal Statistical Society's Primary Health Care Study Group. With the aim of raising the profile of statistics and building research capability in this area, particularly with respect to methodological issues, the study group meetings have covered a wide range of topics that have been of interest to statisticians and non-statisticians alike. The aim of this article is to provide an overview of the statistical issues that have arisen over the years related to the design and evaluation of trials in primary care, to provide useful examples and references for further study and ultimately to promote good practice in the conduct of complex interventions carried out in primary care and other health care settings. Throughout we have given particular emphasis to statistical issues related to the design of cluster randomised trials.