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Studies
Ways to Address RE-AIM Issues
in Efficacy and Effectiveness Studies
| RE-AIM Element |
Efficacy Trials (Phase III Research) |
Effectiveness Trials in Defined Populations (Phase
IV Research) |
| Reach
Strategies |
Specified inclusion criteria or purposeful selection, but participants
will be volunteers in a specific research setting
Report exclusion and participation rates, dropouts, and representativeness |
Include all relevant members of a defined population
Report exclusions, participation rates, drop-outs and representativeness |
| Efficacy
or Effectiveness Strategies |
Measure outcomes using intent to treat assumptions and a high
level of rigor
Assess both positive (anticipated) and negative (unintended) outcomes |
Same as above, though measures are usually more limited
More likely to include economic outcomes |
| Adoption Strategies |
Have potential adoptees assess fit of prototype intervention to
their setting
Include "proxy measures" of adoption —such as participation
among those staff members of a system who will participate in the study |
Assess willingness of stakeholders from multiple settings to
adopt and adapt the program
Report on representativeness of settings, participation rate and
reasons for declining |
| Implementation Strategies |
Collect data on likely treatment demands
Evaluate delivery of intervention protocol by different intervention
agents (usually research staff) |
Assess staff ability to implement key components of the intervention
in routine practice
Evaluate consistency of intervention delivery by agency staff
who are not part of research team |
| Maintenance Strategies |
Assess recidivism among participants
Engage potential community settings in strategic planning efforts
Document extent to which research protocol is retained by setting/agency
once the formal study is completed |
Assess continuation of program over time, and especially after
research phase concludes
Systematically program for and evaluate the level of institutionalization
of the program elements after formal study assistance is terminated |
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