Comparing alternative design options for chronic disease prevention interventions.
BACKGROUND
While the randomized clinical trial is considered to provide the highest level of evidence in clinical medicine, its superiority to other study designs in the context of prevention studies is debated. The purpose of this review was (i) to gather evidence about challenges facing both randomized controlled trials and observational designs for the conduct of population-based chronic disease prevention interventions and (ii) to consider the suitability of recently proposed hybrid designs for population-based prevention intervention studies.


METHODS
Rapid review methods were employed for this study. Articles published within 2007-2012, were included if they: (i) discussed challenges or benefits related to any intervention study design, (ii) compared randomized controlled trials (RCT) and observational designs or (iii) introduced a new study design potentially applicable to population-based interventions. After initial screening, papers retained for inclusion were subjected to content analysis and synthesis.


RESULTS
A total of 35 included articles were reviewed and used for synthesis. Both RCTs and observational studies are subject to multiple challenges, the main being external and internal validity for RCTs and observational designs, respectively. Four new hybrid designs identified.


CONCLUSIONS
Although any high quality design can produce high level of evidence, multiple challenges with prevention intervention RCTs or observational studies identified. New hybrid designs that carry benefits of randomized and observational methods may be the road ahead for to assess the effects of population-based interventions.
Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, ON, Canada; Nuclear Medicine Residency Program, Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
Mohammad
M
Golfam
Reed
R
Beall
Jamie
J
Brehaut
Sara
S
Saeed
Clare
C
Relton
Fredrick D
FD
Ashbury
Julian
J
Little
D002908:Chronic Disease / Q000517:prevention & control*; D006801:Humans; D064887:Observational Studies as Topic / Q000379:methods; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design; D018401:Sample Size; D015983:Selection Bias
Cohort studies; intervention studies; prevention; randomized controlled trial; research design