Intervention Development | 1. Using theory in behavioral intervention development |
2. Use of systematic approaches to move from evidence to intervention components |
3. Specifying intervention components |
4. Exploring impact of mode of intervention delivery |
5. Tailoring interventions to specific populations and contexts |
Comparison Group | 6. Selection of suitable comparison group(s) within trials |
7. Contamination between study arms (intervention and comparison) within trials |
8. Blinding of researchers and participants to study-arm allocation |
Intervention Fidelity | 9. Impact on intervention delivery of characteristics (such as qualifications and training) of those delivering interventions |
10. Strategies to optimize intervention fidelity |
11. Methods to assess intervention fidelity |
12. Strategies to maximize trial participant recruitment and retention |
Pilot/Feasibility trials | 13. Establishing criteria for progressing from trial piloting phases to full randomized controlled trial (RCT) |
14. Sample-size calculations for pilot trials |
15. Novel approaches and designs for piloting behavioral interventions |
Reporting | 16. Standardizing methods for reporting behavioral trials |
17. Reporting intervention and comparison group(s) intervention content |
18. Standardized methods for reporting and registering behavioral trials’ protocols |
Novel Trial Designs | 19. Development of novel research designs to test behavioral interventions as alternatives to, or to complement, standard RCTs |
Data Issues | 20. Strategies for handling missing data within behavioral trials |
21. Developing novel statistical techniques to enhance behavioral trials |
Outcomes | 22. Determining clinically significant changes in outcomes within trials |
23. Selecting appropriate behavioral outcomes for trials |
24. Relationship between behavioral outcomes and clinical/other outcomes |
25. Determining ideal timing of outcome measurement within trials |
26. Measurement of process(es) of change or mechanisms of action within interventions |
Cost-effectiveness | 27. Methods for cost-effectiveness analyses for behavioral trials |
Implementation | 28. Methods for ensuring that behavioral interventions are implementable into practice and policy |
29. How to disseminate behavioral trial research findings to increase implementation |
Stakeholder engagement | 30. How to optimize stakeholder engagement in behavioral trial research |
31. Incorporating stakeholder input in intervention development and delivery |
32. Testing the impact of stakeholder engagement in behavioral trial research |
Development of behavioral science and theory | 33. Trials’ research to test and develop behavioral theories |