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Table 1 Evaluation frameworks guiding the process evaluation and data collection

From: Hypnotherapy for procedural pain, itch, and state anxiety in children with acute burns: a feasibility and acceptability study protocol

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
  1. TFA Theoretical framework of acceptability, NRS Numeric Rating Scale, OIR Outcomes for implementation research
  2. 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]
  3. bAdoption at setting level is already established