Coping with methodological dilemmas; about establishing the effectiveness of interventions in routine medical practice

For this study an ethnographic design was used. We observed and interviewed the researchers and the practice nurses. All gathered research documents, transcribed observations and interviews were analysed thematically.Conducting a pragmatic trial is a continuous balancing act between meeting methodological demands and implementing a complex intervention in routine primary health care. As an effect, the research design had to be adjusted pragmatically several times and the intervention that was meant to be tailor-made became a rather stringent procedure.A pragmatic trial research is a dynamic process that, in order to be able to assess the validity and reliability of any effects of interventions must also have a continuous process of methodological and practical reflection. Ethnographic analysis, as we show, is therefore of complementary value.The question has been raised to what extent evidence from controlled clinical trials on prevention interventions is of value in the routine clinical practice of primary care [1-6]. Explanatory trials, the randomised controlled trials (RCTs) measuring the treatments' efficacy, meet the criteria for valid evaluation through randomisation, recruiting a sufficiently large number of subjects and using control situations [7-9] plus reliable measurements. Pragmatic trials, as opposed to explanatory RCTs, measure the effectiveness of treatments in routine clinical practice [8,10,11]. In pragmatic trials, the definition of the treatments is more or less standardised to correspond with daily clinical decision-making. Additionally, the heterogeneity of patients is reflected, fewer exclusion criteria are used, and blinding, randomisation and control situations may not always be used. As Hotopf argues, pragmatic trials are preferable when health care provision and services are to be evaluated, because their external validity to the extent of their usefulness in routine clinical practice is not compromised [12]. In the literature, pragmatic t