The scientific background and rationale for the implementation strategy (including any underpinning theory/framework/model, how it is expected to achieve its effects and any pilot work). | The scientific background and rationale for the intervention being implemented (including evidence about its effectiveness and how it is expected to achieve its effects). |
Examples Rationale for the implementation strategy | Rationale for the intervention |
Facilitated rapid-cycle quality-improvement techniques (plan-do-study-act cycles [PDSA]) and learning collaboratives are effective in primary care settings, and the two strategies ought to be complementary.21 | … brief interventions delivered in primary care office settings have affected smoking cessation and alcohol consumption. Although less evidence supports brief interventions for improving diet or increasing exercise, there are reasons for optimism.21 |
The Health Decision Model, which combines decision analysis, behavioral decision theory, and health beliefs, is useful to identify patient characteristics related to treatment adherence and subsequent blood pressure control… Successful implementation generally requires a comprehensive approach, in which barriers and facilitators to change in a specific setting are targeted.22 | If not properly controlled, elevated blood pressure (BP) can lead to serious patient morbidity and mortality… Inconsistent patient adherence to the prescribed treatment regimen is known to contribute to poor rates of BP control and improving medication adherence has been shown to be effective in improving BP.22 |
Explanation Authors of implementation studies need to explain the rationale for the choice of implementation strategy and for the validity of the intervention being implemented: | |
It is recommended that reporting the methods, outcomes and conclusions related to the implementation strategy precedes the corresponding reporting of the health outcomes of the intervention (because the key question in an implementation study is about the impact of the implementation strategy). However, authors may wish to reverse this in the introduction and establish that the intervention is effective before explaining the approach they took to implementing it. The use of hybrid study designs, which combine features of clinical effectiveness and implementation studies, may affect the relative emphasis that is placed on the implementation and health intervention aspects of trials.14 |