Table 1.

Distinguishing differences between pragmatic and traditional clinical efficacy trials. Used with permission from Dr. Krist

	Pragmatic study	Traditional clinical efficacy
Stakeholder involvement	Engaged in all study phases including study design, conducting the study, collecting data, interpreting results, disseminating findings	Limited engagement, often in response to investigator ideas or study subjects
Research design	Includes internal and external validity, design fidelity and local adaptation, real life settings and populations, contextual assessments	Focus on limiting threats to internal validity, typically uses randomized controlled trial, participants and settings typically homogenous
Outcomes	Reach, effectiveness, adoption, implementation, comparative effectiveness, sustainability	Efficacy, mechanism identification, component analysis
Measures	Brief, valid, actionable with rapid clinical utility, feasible in real world and low-resource settings	Validated measures that minimize bias, focus on internal consistency and theory rather than clinical relevance
Costs	Assessments include intervention costs and replication costs in relation to outcomes	Often not collected or reported
Data source	May include existing data (electronic health records, administrative data) and brief patient reports	Data generation and collection part of clinical trial
Analyses	Process and outcome analyses relevant to stakeholders and from different perspectives	Specified a priori and typically restricted to investigator hypotheses
Availability of findings	Rapid learning and implementation	Delay between trial completion and analytic availability

Source: Krist et al. Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project. Implement Sci 2013; 8: 73.