Developing a Protocol for Observational Comparative Effectiveness Research

................................................................................................................................................ 7 Overview ............................................................................................................................................... 7 Identifying Decisions, Decisionmakers, Actions, and Context ............................................................ 9 Synthesizing the Current Knowledge Base .......................................................................................... 9 Conceptualizing the Research Problem .............................................................................................. 10 Determining the Stage of Knowledge Development for the Study Design ........................................ 11 Defining and Refining Study Questions Using PICOTS Framework ................................................. 12 Endpoints .................................................................................................................................... 13 Discussing Evidentiary Need and Uncertainty ................................................................................... 13 Additional Considerations When Considering Evidentiary Needs ............................................. 15 Specifying Magnitude of Effect .......................................................................................................... 16 Challenges to Developing Study Questions and Initial Solutions ...................................................... 17 Summary and Conclusion ................................................................................................................... 17 Checklist: Guidance and Key Considerations for Developing Study Objectives and Questions for Observational CER Protocols ............................................................................................................. 18 References........................................................................................................................................... 19 Chapter 2. Study Design Considerations ............................................................................................. 21 Abstract ............................................................................................................................................... 21.............................................................................................................................................. 2