Table 1.
NIH fidelity recommendations
| Fidelity component | Aim | Key considerations |
|---|---|---|
| Study design: The precision with which the ‘active’ components of the intervention can be assessed | To facilitate adequate hypothesis testing regarding underlying theory and clinical processes via: | • Intervention theory, goal and strategies including structure and delivery, role of interventionists, topics, activities, equipment and materials, mode of delivery |
| (1) Ensuring the intervention has sound theoretical underpinnings | • Treatment dose (for example, minimum and ideal frequency, duration and number of sessions) | |
| (2) Monitoring and minimising contamination within and between treatment arms | • Troubleshooting (for example, interventionist dropout) | |
| (3) Measuring treatment dose and intensity | ||
| (4) Identifying and addressing potential setbacks in intervention implementation | ||
| Training providers: The consistency and adequacy of training | To ensure competent acquisition and maintenance of skills to equip providers to effectively deliver the intervention via | • Interventionist differences (for example, skill, education, experience and implementation style) |
| (1) Standardisation | • Threats (for example, intervention complexity and drift in delivery over time) | |
| (2) Steps to minimise skill ‘decay’ or ‘drift’ over time | ||
| Delivery of treatment: Whether the intervention was delivered as intended | To ensure that the intervention is delivered as intended via (1) Standardisation and monitoring | • Behaviours that are unique; essential, but not unique; compatible, but neither essential nor unique and prohibited |
| • Skill with which the intervention is delivered | ||
| • Non-specific treatment effects (for example, warmth, rapport) | ||
| • Assessment method (for example, reliability and validity of assessment measures; assessors; training) | ||
| • Threats (for example, mismatch between intervention and practitioner skill/education/self-efficacy; intervention complexity; contamination across treatment conditions) | ||
| Receipt of treatment: Whether the patient can understand and perform treatment-related behaviours | To monitor and improve patient capacity to acquire knowledge and skills | • Comprehension of, engagement in and adherence to intervention content |
| • Dose received | ||
| Patient enactment: Whether the patient actually performs treatment-related skills in the real world | To monitor and improve patient application of knowledge and skills in real life settings | • NA |