| Efficacy trials (Phase III research) |
Have specified inclusion criteria or purposeful selection, but participants will be volunteers in a specific research setting. |
Measure outcomes using intent to treat assumptions or imputation of missing values and a high level of rigor. |
Have potential adoptees assess fit of prototype intervention to their setting. |
Collect data on likely treatment demands. |
Assess recidivism among participants. |
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Evaluate delivery of intervention protocol by different intervention agents (usually research staff). |
Engage potential community settings in strategic planning efforts from the outset. |
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Report exclusions, participation rates, dropouts, and representativeness on key characteristics. |
Assess both positive (anticipated) and negative (unintended) outcomes. |
Include “proxy measures” of adoption, such as participation among those staff members of a system who will participate in the study. |
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Document extent to which research protocol is retained by setting/agency once the formal study is completed. |
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Report effects of moderator variables. |
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| Effectiveness trials in defined populations (Phase IV research) |
Include all relevant members of a defined population. |
Address as above, though measures are usually more limited. |
Assess willingness of stakeholders from multiple settings to adopt and adapt the program. |
Assess staff ability to implement key components of the intervention in routine practice. |
Assess continuation of program over time, and especially after research phase concludes. |
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Report exclusions, participation rates, dropouts, and representativeness. |
Include economic outcomes. |
Report on representativeness of settings, participation rate, and reasons for declining. |
Evaluate consistency of intervention delivery by agency staff who are not part of research team. |
Systematically program for and evaluate the level of institutionalization of the program elements after formal study assistance is terminated. |
