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Published on: May 2, 2025
Development and content validation of WoundPilot: a clinical decision support system for structured wound assessment
Steven Smet1, Hilde Beele2, Lies Van De Voorde3
1Wound Care Centre, Ghent University Hospital, Ghent, Belgium; Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery (UCVV), Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.
Aim:
This study aimed to develop and content-validate a computerised clinical decision support system (CDSS) to support primary care clinicians in structured wound assessment and decision-making, by standardising assessment, guiding treatment planning, and reducing variability in practice.
Methods:
An adapted RAND/UCLA Appropriateness Method was applied to develop and assess the content validity of the CDSS. A panel of two clinical nurse specialists, one dermatologist, and one nursing professor constructed a clinical decision support tree based on evidence and guidelines, which was transformed into an interactive tool. Two validation rounds were conducted with wound care experts (n = 36 invited; 24 participated in round 1 and 22 in round 2), who evaluated the relevance, comprehensiveness, and clarity of each node using the item-level content validity index (I-CVI).
Results:
The initial CDSS emphasized assessment of wound etiology, infection, wound bed, exudate, and wound edges. In round 1, most nodes achieved acceptable validity (I-CVI >0.78), and revisions improved infection assessment, wound classification, and exudate definitions. In round 2, all nodes met the I-CVI threshold, confirming strong content validity. The final CDSS, named WoundPilot, incorporated expert feedback, simplified navigation, and included supportive definitions, images, and referral guidance.
Conclusion:
WoundPilot provides a structured, holistic tool for wound management in primary care, offering a content-validated framework for structured wound assessment and decision-making. Clinical validation is required to evaluate its usability, reliability, integration with digital platforms, and performance in real-world settings. The system was designed for subsequent translation and international validation in comparable healthcare contexts.
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