Chapter 6. Description of Ideal Evaluation Methods: Overview
Assessing the Evidence for Context-Sensitive Effectiveness and Safety
The overriding finding of our project is that in order to better understand the context-sensitivity of the effectiveness and safety of patient safety practices (PSPs) we need to move past the discussion of the merits of the traditional study designs aimed at assessing causality (e.g., "randomized trials" versus "observational studies"). We also need to pay far more attention to other important features currently missing from most published reports of PSP implementations. These features include:
- A presentation of why or how the PSP should work. What is the theory supporting why this particular intervention should influence the target patient safety outcome? What is the logic model for how the PSP should work?
- A description of the PSP in sufficient detail that readers could replicate it. PSPs are often complex interventions and cannot be described in only a few sentences.
- A description of key contextual domains.
- A description of the implementation process. For many PSPs, the line between the intervention and the implementation is not sharp, and the intervention and implementation may be considered to be a single construct.
- An assessment of what actually happened during implementation of the PSP. What went as planned, and what happened that was unexpected?
- An assessment of the results achieved, including benefits and harms.
- An analysis of how the effectiveness and safety of the PSP varied as a function of the key contextual domains.
The remaining seven chapters of the report address these features in more detail.