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


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Jansen
Yvonne J F M
YJ
Institute of Health Policy and Management, Erasmus MC Rotterdam, Rotterdam, The Netherlands. y.jansen@erasmusmc.nl
Bal
Roland
R
Bruijnzeels
Marc
M
Foets
Marleen
M
Frenken
Rianne
R
de Bont
Antoinette
A
D000328:Adult; D000368:Aged; D000884:Anthropology, Cultural; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D036262:Empirical Research; D005260:Female; D006302:Health Services Research / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010348:Patient Care Team; D011204:Poverty Areas; D011320:Primary Health Care / Q000458:organization & administration*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012111:Residence Characteristics; D019037:Urban Health Services / Q000458:organization & administration*; D035862:Vulnerable Populations