Abstract
BackgroundThe aim of this paper is to show how researchers balance between scientific rigour and localisation in conducting pragmatic trial research. Our case is the Quattro Study, a pragmatic trial on the effectiveness of multidisciplinary patient care teams used in primary health care centres in deprived neighbourhoods of two major cities in the Netherlands for intensified secondary prevention of cardiovascular diseases.MethodsFor 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.ResultsConducting 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.ConclusionA 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.
Highlights
The aim of this paper is to show how researchers balance between scientific rigour and localisation in conducting pragmatic trial research
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 [1,2,3,4,5,6]
In this paper we show how researchers balance between scientific rigour and localisation in pragmatic trial research
Summary
The aim of this paper is to show how researchers balance between scientific rigour and localisation in conducting pragmatic trial research. Our case is the Quattro Study, a pragmatic trial on the effectiveness of multidisciplinary patient care teams used in primary health care centres in deprived neighbourhoods of two major cities in the Netherlands for intensified secondary prevention of cardiovascular diseases. 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 [1,2,3,4,5,6]. As opposed to explanatory RCTs, measure the effectiveness of treatments in routine clinical practice [8,10,11]. 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]. Pragmatic trials are considered to provide a realistic alternative to conventional RCTs [10,11,13,14]
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