Question |
Efficacy—can the intervention work? |
Effectiveness—does the intervention work when used in normal practice? |
Setting |
Well resourced, “ideal” setting |
Normal practice |
Participants |
Highly selected. Poorly adherent participants and those with conditions which might dilute the effect are often excluded |
Little or no selection beyond the clinical indication of interest |
Intervention |
Strictly enforced and adherence is monitored closely |
Applied flexibly as it would be in normal practice |
Outcomes |
Often short term surrogates or process measures |
Directly relevant to participants, funders, communities, and healthcare practitioners |
Relevance to practice |
Indirect—little effort made to match design of trial to decision making needs of those in usual setting in which intervention will be implemented |
Direct—trial is designed to meet needs of those making decisions about treatment options in setting in which intervention will be implemented |