title: Patient-Reported Outcome Instruments for Surgical and Traumatic Scars: A Systematic Review of their Development, Content, and Psychometric Validation.
abstract: 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 6534 articles. After review, we identified four 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.
  
  
  METHODS
  This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to Table of Contents or the online Instructions to Authors www.springer.com/00266 .
authors.affiliation: College of Physicians and Surgeons, Columbia University, 630 West 168th Street, New York, NY, USA.
authors.forename: Lily R
authors.initials: LR
authors.lastname: Mundy
authors.affiliation: School of Medicine, University of Washington, 4333 Brooklyn Avenue Northeast, Seattle, WA, USA.
authors.forename: H Catherine
authors.initials: HC
authors.lastname: Miller
authors.affiliation: Departments of Pediatrics and Clinical Epidemiology & Biostatistics, McMaster University, 1280 Main Street West, Hamilton, ON, Canada.
authors.forename: Anne F
authors.initials: AF
authors.lastname: Klassen
authors.affiliation: Clinical Neurology Research Group, Peninsula Schools of Medicine and Dentistry, Plymouth University, Drake Circus, Plymouth, Devon, UK.
authors.forename: Stefan J
authors.initials: SJ
authors.lastname: Cano
authors.affiliation: Plastic and Reconstructive Service, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA. PusicA@mskcc.org.
authors.forename: Andrea L
authors.initials: AL
authors.lastname: Pusic
mesh_terms: D002921:Cicatrix / Q000453:epidemiology / Q000209:etiology / Q000523:psychology*; D005260:Female; D006801:Humans; D008297:Male; D000071066:Patient Reported Outcome Measures; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D011594:Psychometrics; D011788:Quality of Life; D000072836:Surgical Wound / Q000150:complications / Q000523:psychology; D014947:Wounds and Injuries / Q000150:complications / Q000601:surgery*
keywords: Cicatrix; Instrument; Measure; Patient-reported outcome; Quality of life; Scar; Systematic review