Table 1.
Evaluation frameworks guiding the process evaluation and data collection
| Evaluation framework | Implementation outcome | Definition | Data collection | ||
|---|---|---|---|---|---|
| Source | Type | ||||
| RE-AIM [30, 31] | Reacha | Willingness of eligible families to participate in the study | Report on the rate of approached eligible families who consent to participate | Quantitative | |
| Effectiveness | Extent to which the intervention eliciting intended effects and the overall perceived benefits and potential undesired effects | Numeric ratings of pain, anxiety, and itch; physiologic measures of distress; data on wound re-epithelialisation | Quantitative | ||
| Reported adverse events | Qualitative | ||||
| Reported perceived benefits | Qualitative | ||||
| Adoption by cliniciansb | Willingness of clinicians to take part in the study | Report on the rate of clinicians conducting dressing changes who consent to join the study | Quantitative | ||
| Implementation | The quality of delivery and consistent delivery of study procedures as intended or prescribed in the protocol (i.e. fidelity) | Report on retention rates among children | Quantitative | ||
| Level of adherence to the fidelity checklist in delivering the intervention | Quantitative | ||||
| Completeness of collected data on health outcomes | Quantitative | ||||
| Additional adaptations and modifications | Qualitative | ||||
| Maintenance | Degree of long-term outcomes by participants or program sustainability within the setting | Not assessed due to the absence of follow-up | |||
| TFA [27] | Acceptability | Perceived self-efficacy | Confidence in the ability to accomplish the behaviour(s) needed to participate in the intervention | Level of children’s perceived self-efficacy on a Likert scale | Quantitative |
| Ethicality | Level of understanding of the intervention | Level of children’s positive therapy expectations on a Likert scale | Quantitative | ||
| Coherence | Degree to which the intervention fits well with participants’ beliefs and value system | Semi-structured interview on beliefs and views of children and parents on hypnotherapy | Qualitative | ||
| Perceived effectiveness | The degree to which the intervention is perceived as likely to succeed in its purpose | Families’ and clinicians’ satisfaction with hypnotherapeutic sessions and study procedures (procedures are not rated by clinicians) on NRS | Quantitative | ||
| Semi-structured interview with parents, children, and clinicians on likes, dislikes, and recommendations | Qualitative | ||||
| Perceived burden | Perceived extent of effort required to engage in the intervention | Semi-structured interview on perceived required time and cognitive effort for the intervention | Qualitative | ||
| OIR [28] | Feasibility | The extent to which study procedures can be successfully delivered to participants in a distinctive context that is not fully controlled |
- Number of disruptions - Available time (recordings) |
Quantitative | |
| Field notes on the adequacy of resources | Qualitative | ||||
TFA Theoretical framework of acceptability, NRS Numeric Rating Scale, OIR Outcomes for implementation research
aRepresentativeness (i.e. the similarity between participants and eligible patients) will not be assessed as part of Reach due to the small sample size [31]
bAdoption at setting level is already established