Prevention of pressure injury (PI) in hospitalised infants, children, and young people (CYP) (aged 0-19 years): Modification and validation of a PI risk assessment tool for infants and CYP with darker skin tones.

Research question: How accurate is the BRADEN-QD in capturing risk of pressure injury (PI) in hospitalised infants and children and young people (CYP) with dark skin tones (DST)?

Background: Globally, infants and CYP are sometimes harmed due to PI and/or skin integrity problems during hospitalisation.

PI prevalence for hospitalised infants and CYP ranges from 1.4% to 8% with those that are critically ill having higher prevalence (up to 43%), attributable to extreme physiological disequilibrium, immobility, and malnutrition.

PIs can negatively impact the physical, emotional, and medical outcomes for infants/CYP and have an economic and health utilisation impact for healthcare organisations.

CYP with DST have been under-served and under-represented in many PI risk prediction tool development studies, limiting generalisability, accuracy and utility in diverse patient groups. We need to make sure that tools are fit for purpose for all.

Aim: To evaluate critical gaps in knowledge and evidence by modification (as required) and validation of the BRADEN-QD in hospitalised infants and CYP with DST.

Objectives: To identify and gain consensus on additional factors pertinent to hospitalised CYP with DST for inclusion in the BRADEN-QD [Phase 1]. To validate the original/modified BRADEN-QD in a DST population through multi-centre study [Phase 2].

Methods: Phase 1 [Months 0-9]: Stage 1 [Months 0-6]- Systematic review and meta-analysis of current literature to identify and quantify PI risk factors in hospitalised infants and CYP.

A review protocol will be registered on PROPSERO, PEO framework will be used to develop search terms and strategy, various electronic databases will be searched by an experienced medical librarian.

Stage 2 [Months 3-7]– Using data from stage 1 as a baseline, a purposive sample size of 20 diverse participants (7 CYP, 7 parents, 6 healthcare professionals/experts) will be interviewed to identify PI risk factors not captured from the literature. Interviews will be conducted online or face-to-face according to participant preference.

Interviews will be recorded and transcribed verbatim.

Stage 3 [Months 8-9]– participants from Stage 2 will take part in a Nominal Group Technique workshop to rank, according to relevance and importance, the PI risk items identified from Stages 1&2. Phase 2 [Months 9-18]: Multi-centre study to evaluate the accuracy and validity of the original or modified BRADEN-QD.

A prospective cohort of 522 hospitalised CYP will be stratified according to skin tone. PI assessment will be conducted at scheduled visits up to 8 times if the child is still in hospital by day 28.

PI risk assessment tool accuracy will be evaluated by comparison of specificity and sensitivity of the modified PI tool with the original BRADEN-QD.

Anticipated Impact and Dissemination: At the end of this study, we will have a valid and reliable PI assessment tool for use with hospitalised CYP of all skin tones.

This will enhance accuracy of daily PI risk assessment at the patient bedside and in development of future studies on PI complex interventions.

We will disseminate the results of this study through publications, infographics, and conference presentation to professionals, our network of patient participants, and expert panel.