Table 3.
Checklist of key considerations when developing a quasi-experimental study
| CONSIDERATIONS FOR RETROSPECTIVE AND PROSPECTIVE QUASI-EXPERIMENTAL STUDIES |
| 1. Determine PICO: population, intervention, control group, outcomes (specify primary vs. secondary outcomes) |
| 2. What is the hypothesis? |
| 3. Is it ethical or feasible to randomize patients to the intervention? |
| 4. Will this be a retrospective or prospective study or a combination of both? |
| 5. What are the main inclusion and exclusion criteria? |
| 6. Will anyone (participants, study staff, research team, analyst) be blinded to the intervention assignment? |
| 7. Consider options for control group |
| 8. Consider options for nonequivalent dependent variable |
| 9. How will the observations (outcomes) be measured? |
| 10. How many observations can be measured pre and post intervention? |
| 11. How should the observations be spaced to account for seasonality? Weekly? Monthly? Quarterly? |
| 12. Do you hypothesize that the intervention will diffuse quickly or slowly? (e.g. are changes in the outcomes expected right away or only after a phase-in period?) |
| 13. Do you hypothesize that the intervention will have a lasting effect on the outcome? (If yes, do not use cross-over design) |
| 14. What is the analysis plan? (Consult a statistician) |
| 15. If the unit of analysis differs from the unit of assignment, what analytical method will be used to account for this (e.g. adjusting the standard error estimates by the design effect or using multilevel analysis)? |
| 16. What sample size is needed to be powered to see a significant difference? (Consult a statistician) |
| 17. Will the analysis strategy be intention to treat or how will non-compliers be treated in the analysis? |
| ADDITIONAL CONSIDERATIONS FOR QUASI-EXPERIMENTAL STUDIES WITH PROSPECTIVE COMPONENTS |
| 18. What will be the unit of delivery? (e.g. Individual patient or unit or hospital) |
| 19. How will the units of delivery be allocated to the intervention? |
| 20. Who will deliver the intervention? (e.g. study team or healthcare workers) |
| 21. How and when will the intervention be delivered? |
| 22. How will compliance with the intervention be measured? |
| 23. Will there be activities to increase compliance or adherence? (e.g. incentives, coaching calls) |