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Table 1 NIH fidelity recommendations

From: Fidelity considerations in translational research: Eating As Treatment — a stepped wedge, randomised controlled trial of a dietitian delivered behaviour change counselling intervention for head and neck cancer patients undergoing radiotherapy

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