Section 1: Pragmatic Research Questions

1.1 Research Question Considerations

 In pragmatic research, the research question:

  • Tests if an intervention is effective in routine practice or service setting, often compared to well-defined usual care or existing programs and/or other comparator interventions. What intervention(s) or comparator(s) will you test?
  • Considers the organization (and its existing personnel and infrastructure). What organization type(s) are relevant? Are the resources and expertise required for program delivery available in typical delivery settings?

References

  • Karanicolas PJ, Montori VM, Devereaux PJ, Schünemann H, Guyatt GH. A new ‘mechanistic-practical” framework for designing and interpreting randomized trials. J Clin Epidemiol. 2009;62(5):479-484. doi:10.1016/j.jclinepi.2008.02.009
  • Patsopoulos NA. A pragmatic view on pragmatic trials. Dialogues Clin Neurosci. 2011;13(2):217-224. doi:10.31887/DCNS.2011.13.2/npatsopoulos
  • Godwin M, Ruhland L, Casson I, et al. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med Res Methodol. 2003;3:28. Published 2003 Dec 22. doi:10.1186/1471-2288-3-28
  • Sox HC, Lewis RJ. Pragmatic Trials: Practical Answers to “Real World” Questions. JAMA. 2016;316(11):1205-1206. doi:10.1001/jama.2016.11409
  • Kilbourne AM, Switzer G, Hyman K, Crowley-Matoka M, Fine MJ. Advancing health disparities research within the health care system: a conceptual framework. Am J Public Health. 2006;96(12):2113-2121. doi:10.2105/AJPH.2005.077628
  • Kilbourne AM, Goodrich DE, Miake-Lye I, Braganza MZ, Bowersox NW. Quality Enhancement Research Initiative Implementation Roadmap: Toward Sustainability of Evidence-based Practices in a Learning Health System. Med Care. 2019;57 Suppl 10 Suppl 3(10 Suppl 3):S286-S293. doi:10.1097/MLR.0000000000001144

Videos

An Introduction to Pragmatic Trials: A View into the Rationale and Process of Real-Life interventions

Let’s Get Real: Planning Rigorous Pragmatic Health Services Research for Equitable, Real-World Care

1.2 Settings and Populations

The settings studied in pragmatic research are typical delivery settings (e.g., typical workplaces, schools, or communities) rather than highly specialized types of these settings.

In a highly pragmatic study, the population of interest will be defined by:

  • Broad eligibility criteria to represent “typical real-world” recipients of this program.
  • A recruitment path that leverages typical workflows in clinical/community settings (e.g., registry data, best practice alerts, other).

References

  • Pfaff E, Lee A, Bradford R, et al. Recruiting for a pragmatic trial using the electronic health record and patient portal: successes and lessons learned. J Am Med Inform Assoc. 2019;26(1):44-49. doi:10.1093/jamia/ocy138

1.3 Pragmatic Research Questions

To begin your pragmatic research plan, start by asking yourself these questions:

  • What are my research questions?
  • What makes this research “pragmatic”? That is, what sense is it designed to produce evidence relevant to real-world health issues, populations, and health care settings?
  • What intervention(s) will be tested? How will the intervention(s) be implemented, ideally making use of existing service structures, systems, and processes?
  • What is the level of evidence for the intervention(s) to be tested? Will this be a pilot effectiveness study or is it ready for a dissemination and/or implementation (D&I) study?
  • What level(s) of change are relevant? (e.g., individual, provider, setting, policy levels)
  • What characteristics of the setting or context are relevant to the research questions?
  • What is the timeframe for this project?