An alternative trial design to overcome validity and recruitment problems in primary care research.
BACKGROUND
Although the randomized controlled trial is widely accepted as the best design to investigate new interventions, conducting a trial in primary care may present researchers with many methodological problems.


OBJECTIVE
Our aim was to present an alternative trial design to overcome internal validity and recruitment problems.


METHODS
In a randomized controlled trial, fatigued employees absent from work were selected among the population of an occupational health service in the South of The Netherlands. Patients randomly assigned to the experimental condition received cognitive behavioural therapy by a research GP near their home address, whereas patients in the control group received no intervention. We describe our considerations for building an alternative design. Research GPs and patients were recruited separately for the study. The pre-randomization design was applied.


RESULTS
Nine research GPs performed all the interventions. Seventy-six experimental patients and 75 control patients were selected for study participation. Of these, only six patients in the experimental group and seven patients in the control group withdrew from the study at some point during follow-up.


CONCLUSIONS
Results suggest that recruitment and randomization procedures in the alternative design served their purpose well. The alternative design proposed here might have several advantages compared with conventional trial procedures. However, our design is not widely applicable and there are ethical aspects involved that should be considered. Researchers should address their creativity when trying to minimize the problems they may encounter in designing a study.
Huibers
Marcus J H
MJ
Department of Epidemiology, Maastricht University, The Netherlands. m.huibers@dmkep.unimass.nl
Bleijenberg
Gijs
G
Beurskens
Anna J H M
AJ
Kant
I Jmert
IJ
Knottnerus
J André
JA
van der Windt
Daniëlle A W M
DA
Bazelmans
Ellen
E
van Schayck
Constant P
CP
D000041:Absenteeism; D002908:Chronic Disease; D015928:Cognitive Behavioral Therapy; D005221:Fatigue / Q000628:therapy; D006801:Humans; D009426:Netherlands; D018579:Patient Selection; D011320:Primary Health Care / Q000379:methods*; D011897:Random Allocation; D045808:Refusal to Participate; D015203:Reproducibility of Results; D012106:Research / Q000592:standards*; D012107:Research Design; D016896:Treatment Outcome