Ways to Address Efficacy/Effectiveness in Efficacy and Effectiveness Studies

During Efficacy Trials (Phase III Research), do these things to address Efficacy/Effectiveness:

• Measure outcomes using intent to treat assumptions and a high level of rigor.
• Assess both positive (anticipated) and negative (unintended) outcomes.

During Effectiveness Trials (Phase IV Research), do these things to address Efficacy/Effectiveness:

• Use the same strategies as listed above, although measures are usually more limited.
• In this phase, the outcomes to be assessed are more likely to be economic in nature.

Common Challenge Encountered in Evaluating Health Behavior Interventions and Remedies

Not thoroughly understanding outcomes or how they come about, e.g., no knowledge of mediators, conflicting or amgibuous results, or inadequate control conditions to rule out alternative hypotheses might be remedied by doing these things:

• Assess broad set of outcomes including possible negative ones.
• Include measures of hypothesized mediators.
• Conduct subgroup analyses or include different assessment points.
• Select stringency of control condition to fit your question.

Questions to Ask about Efficacy/Effectiveness when Evaluating Health Promotion Programs and Policies

• What impact did the intervention have on all participants who began the program?
• What impact did the intervention have on process intermediate outcomes and primary outcomes?
• What impact did the intervention have on both positive and negative (unintended) outcomes, including quality of life?

The Questions

• Does program achieve key targeted outcomes?
• Does program produce unintended adverse consequences?
• How will impact on quality of life (QOL) be assessed?

Possible Ways to Enhance Dissemination

• Incorporate more tailoring to individual.
• Reinforce via repetition, multiple modalities, social support and systems change.
• Use stepped care approach.
• Evaluate adverse outcomes and QOL for program revision and cost-to-benefit analysis.

Individual Target Level

• Tailor to individual
• Stepped care
• Outreach components
• Evolve over time

Delivery Site or Organization Level

• Report at each contact
• Proactive planning
• Record goals
• Elicit patient or participant barriers and concerns

Systems or Network Level

• Seek public feedback
• Adopt goals as part of organizational mission
• CQI
• Collaborate and network

Addressing Other Elements

Click on other elements listed below to access related resources.

• Reach
• Adoption
• Implementation
• Maintenance