Reducing the confusion and controversies around pragmatic trials: using the Cardiovascular Health Awareness Program (CHAP) trial as an illustrative example.
Knowledge translation (KT) involves implementation of evidence-based strategies and guidelines into practice to improve the process of care and health outcomes for patients. Findings from pragmatic trials may be used in KT to provide patients, healthcare providers and policymakers with information to optimize healthcare decisions based on how a given strategy or intervention performs under the real world conditions. However, pragmatic trials have been criticized for having the following problems: i) high rates of loss to follow-up; ii) nonadherence to study intervention; iii) unblinded treatment and patient self-assessment, which can potentially create bias; iv) being less perfect experiments than efficacy trials; v) sacrificing internal validity to achieve generalizability; and vi) often requiring large sample sizes to detect small treatment effects in heterogeneous populations. In this paper, we discuss whether these criticisms hold merit, or if they are simply driven by confusion about the purpose of pragmatic trials. We use the Cardiovascular Health Awareness Program (CHAP) trial--a community randomized pragmatic trial designed to assess whether offering a highly organized, community-based CHAP intervention compared to usual care can reduce cardiovascular disease-related outcomes--to address these specific criticisms and illustrate how to reduce this confusion.


BACKGROUND
Current controlled trials ISRCTN50550004 (9 May 2007).
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. thabanl@mcmaster.ca.|Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare, Hamilton, ON, Canada. thabanl@mcmaster.ca.|Departments of Paediatrics and Anaesthesia, McMaster University, Hamilton, ON, Canada. thabanl@mcmaster.ca.|Centre for Evaluation of Medicine, St Joseph's Healthcare, Hamilton, ON, Canada. thabanl@mcmaster.ca.|Department of Family Medicine, McMaster University, McMaster Innovation Park, Hamilton, ON, Canada. thabanl@mcmaster.ca.|Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada. thabanl@mcmaster.ca.
Lehana
L
Thabane
Department of Family Medicine, McMaster University, McMaster Innovation Park, Hamilton, ON, Canada. janusz.kaczorowski@umontreal.ca.|Department of Family and Emergency Medicine, Université de Montréal, Montreal, QC, Canada. janusz.kaczorowski@umontreal.ca.|University of Montreal Hospital Research Centre (CRCHUM), Montreal, QC, Canada. janusz.kaczorowski@umontreal.ca.
Janusz
J
Kaczorowski
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. ldolovic@mcmaster.ca.|Centre for Evaluation of Medicine, St Joseph's Healthcare, Hamilton, ON, Canada. ldolovic@mcmaster.ca.|Department of Family Medicine, McMaster University, McMaster Innovation Park, Hamilton, ON, Canada. ldolovic@mcmaster.ca.
Lisa
L
Dolovich
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. LChambers@bruyere.org.
Larry W
LW
Chambers
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. mbuagblc@mcmaster.ca.|Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare, Hamilton, ON, Canada. mbuagblc@mcmaster.ca.|Centre for the Development of Best Practices in Health, Yaoundé Central Hospital, Yaoundé, Cameroon. mbuagblc@mcmaster.ca.
Lawrence
L
Mbuagbaw
D000367:Age Factors; D001364:Awareness; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*; D003153:Community Health Services; D019317:Evidence-Based Medicine; D007722:Health Knowledge, Attitudes, Practice; D006302:Health Services Research / Q000379:methods*; D006304:Health Status; D006801:Humans; D009864:Ontario; D010353:Patient Education as Topic; D017410:Practice Guidelines as Topic; D012107:Research Design; D012307:Risk Factors; D016896:Treatment Outcome