Table 7: Criteria for assigning strength of evidence
Assessing the Evidence for Context-Sensitive Effectiveness and Safety
Does this evidence help me decide whether I can implement this PSP in my organization and get a similar result?
Type of evidence:
Randomized trial = high
Decrease score if:
- No explanation of why the PSP might work, either in terms of theory, logic models, or prior success in other fields or in pilot studies (-1).
- No reporting of contexts, including at least structural organizational characteristics, external factors, patient safety culture, leadership, teamwork, or implementation tools (-1).
- PSP not described in sufficient detail to permit replication (-1).
- No reporting of the implementation process, assessment of unplanned events, or changes to workflow (-1).
- No assessment of the effect of contexts on implementation effectiveness (-1).
Observational study = low
Increase score if:
- Consistent results obtained in multiple studies (+2).
- Use of observational study designs of stronger internal validity (controlled before-and after, time series, statistical process control) (+1).
- Very strong effect (+1).
- Use of theory/logic models, assessment of contexts, reporting of implementation process, and fidelity of implementation (+1).
Any other evidence = insufficient
Across all study types, decrease score if:
- Serious (-1) or very serious (-2) limitation to study quality.
- Important inconsistency across studies (-1).
- Imprecise or sparse data (-1).
- High probability of reporting bias (-1).