Development and Preliminary Validation of a Central Venous Access Device-Associated Skin Impairment Classification Tool Using Modified Delphi and Clinimetric Methods

An evidence and consensus-based instrument is needed to classify central venous access device-associated skin impairments. The aim of this study was to design and evaluate the central venous access device-associated skin impairment classification tool. A two-phase modified Delphi study. This two-phase study consisted of a literature review, followed by the development and validation of a classification instrument, by experts in the fields of central venous access devices and wound management (Phase 1). The instrument was tested (Phase 2) using 38 clinical photographs of a range of relevant skin impairments by the same expert panel. The expert panel consisted of registered nurses who were clinical researchers (n = 4) and clinical experts (n = 3) with an average of 24 years of nursing and research experience and 11 years of experience in wound management. Measures to assess preliminary content validity and inter-rater reliability were used. The instrument consists of five overarching aetiological classifications, including contact dermatitis, mechanical injury, infection, pressure injury and complex clinical presentation, with 14 associated subcategory diagnoses (e.g., allergic dermatitis, skin tear and local infection), with definitions and signs and symptoms. High agreement was achieved for preliminary scale content validity and item content validity (I-CVI = 1). Inter-rater reliability of aetiologies was high. The overall inter-rater reliability of individual definitions and signs and symptoms had excellent agreement. The development and preliminary validation of this classification tool provide a common language to guide the classification and assessment of central venous access device-associated skin impairment. The comprehensive and validated classification tool will promote accurate identification of central venous access device-associated skin impairment by establishing a common language for healthcare providers. The availability of this tool can reduce clinical uncertainty, instances of misdiagnosis and the potential for mismanagement. Consequently, it will play a pivotal role in guiding clinical decision-making, ultimately enhancing the quality of treatment and improving patient outcomes. The Guidance on Conducting and Reporting Delphi Studies (CREDES) was adhered to. No patient or public contribution.