Strategies to improve adherence to interventions {11c}
RECRUITMENT
ResNs allocated to each site received training regarding Good Clinical Practice (GCP), the study protocol (including subsequent amendments), intervention, recruitment strategies, data collection using an electronic database, and inspection of the sacrum surgical site including how to take photographs (in terms of consistent angle, lighting, and distance where possible) and edit photographs prior to commencement in the role. A manual detailing the standard operating procedures (SOP) for the trial (including subsequent updates) is available to all members of the research team for top-up training to ensure ongoing protocol adherence and consistency. The information provided ensures all participants receive identical verbal and written information and instructions regarding the study. In addition, ResNs have received education from the dressing manufacturer representatives.Audits of 10% of photographs have been taken to evaluate the quality of photographs (e.g. lighting, angle, distance) and photo modification to conceal dressing markings. Detailed instructions and images have been added to the SOP to provide continued support to ResNs and training new staff.Regular assessment of treatment fidelity by the clinical trial coordinator (CTC) focuses on data integrity, the trial dressing and its application, photography, and image editing. Fleiss Kappa analysis will estimate inter-rater reliability between blinded outcome assessors. A score of ≥08 will be considered acceptable.