Background
Patient-reported outcomes (PROs) are of growing importance in research and clinical care and may be used as primary outcomes or as compliments to traditional surgical outcomes. In assessing the impact of surgical and traumatic scars, PROs are often the most meaningful. To assess outcomes from the patient perspective, rigorously developed and validated PRO instruments are essential.
Methods
The authors conducted a systematic literature review to identify PRO instruments developed and/or validated for patients with surgical and/or non-burn traumatic scars. Identified instruments were assessed for content, development process, and validation under recommended guidelines for PRO instrument development.
Results
The systematic review identified 6,534 articles. After review, we identified 4 PRO instruments meeting inclusion criteria: Patient and Observer Scar Assessment Scale (POSAS), Bock Quality of Life Questionnaire for Patients with Keloid and Hypertrophic Scarring (Bock), Patient Scar Assessment Questionnaire (PSAQ), and Patient-Reported Impact of Scars Measure (PRISM). Common concepts measured were symptoms and psychosocial well-being. Only PSAQ had a dedicated appearance domain. Qualitative data were used to inform content for the PSAQ and PRISM, and a modern psychometric approach (Rasch Measurement Theory) was used to develop PRISM and to test POSAS. Overall, PRISM demonstrated the most rigorous design and validation process, however was limited by the lack of a dedicated appearance domain.
Conclusions
PRO instruments to evaluate outcomes in scars exist but vary in terms of concepts measured and psychometric soundness. This review discusses the strengths and weaknesses of existing instruments, highlighting the need for future scar-focused PRO instrument development.