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Table 1 The “long-list” of items for methodological research in trials of behavioral interventions agreed in Phase 1

From: An international, Delphi consensus study to identify priorities for methodological research in behavioral trials in health research

CategoriesItem
Intervention Development1. 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 Group6. 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 Fidelity9. 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 trials13. 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
Reporting16. 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 Designs19. Development of novel research designs to test behavioral interventions as alternatives to, or to complement, standard RCTs
Data Issues20. Strategies for handling missing data within behavioral trials
21. Developing novel statistical techniques to enhance behavioral trials
Outcomes22. 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-effectiveness27. Methods for cost-effectiveness analyses for behavioral trials
Implementation28. Methods for ensuring that behavioral interventions are implementable into practice and policy
29. How to disseminate behavioral trial research findings to increase implementation
Stakeholder engagement30. 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 theory33. Trials’ research to test and develop behavioral theories