Development of a New Patient-Reported Outcome Instrument to Evaluate Treatments for Scars

The SCAR-Q

Anne F. Klassen, DPhil; Natalia Ziolkowski, MD; Lily R. Mundy, MD; H. Catherine Miller, MD; Alison McIlvride, BA; Allison DiLaura, BS; Joel Fish, MD, MSc, FRCSC; Andrea L. Pusic, MD, MHS, FACS, FRCSC

Disclosures

Plast Reconstr Surg Glob Open. 2018;6(4):e1672 

In This Article

Abstract and Introduction

Abstract

Background: Every year millions of individuals acquire scars. A literature review of patient-reported outcome (PRO) instruments identified content limitations in existing scar-specific measures. The aim of this study was to develop a new PRO instrument called SCAR-Q for children and adults with surgical, traumatic, and burn scars.

Methods: We performed a secondary analysis of the qualitative datasets used in the development of PRO instruments for plastic and reconstructive surgery, that is, BREAST-Q, FACE-Q, BODY-Q, and CLEFT-Q. The keyword "scar*" was used to extract scar-specific text. Data were analyzed to identify concepts of interest and to form a comprehensive item pool. Scales were developed and refined through multiple rounds of cognitive interviews with patients and with input from international clinical experts between July 2015 and December 2016.

Results: A total of 52 children and 192 adults from the qualitative datasets provided between 1 and 34 scar-specific codes (n = 1,227). The analysis led to the identification of 3 key domains for which scales were developed: scar appearance (eg, size, color, contour), scar symptoms (eg, painful, tight, itchy), and psychosocial impact (eg, feeling self-conscious, bothered by scar). Cognitive interviews with 25 adults and 20 pediatric participants with scars, plus feedback from 27 clinical experts, led to rewording and removal of items, and new items added. These steps ensured content validity for SCAR-Q in a broad range of scars.

Conclusions: The SCAR-Q is now being field-tested. Once completed, we anticipate SCAR-Q will be used in clinical practice and in clinical trials to test different scar therapies.

Introduction

Millions of scars from surgical interventions, burns, and trauma occur annually.[1] The annual operative burden worldwide is 234 million operations, with 1 in 25 individuals expected to undergo surgery that results in a visible scar.[1] Although numerous clinical outcome assessment (COA) tools are used to evaluate scars, such tools represent the perspective of the health care provider.[2] Although such COA tools have been used extensively, and are hence well known, they do not measure how a patient feels and functions. To measure the patient perspective, a patient-reported outcome (PRO) instrument is needed.[2]

PRO instruments are rating scales that measure outcomes that matter to patients by asking them directly.[2] Mundy et al.[3] reviewed the development and content of PRO instruments designed for surgical and traumatic scars and found 4 scales as follows: Patient and Observer Scar Assessment Scale,[4] Bock Quality of Life Questionnaire for Patients with Keloid and Hypertrophic Scarring,[5] Patient Scar Assessment Questionnaire,[6] and the Patient-Reported Impact of Scars Measure.[7] These PRO instruments, designed for both children and adults, focus mainly on the measurement of symptoms and psychological issues. No PRO instrument exists that comprehensively measures scar appearance (eg, size, shape, color, contour). Since treatments aim to specifically improve the appearance of scars, asking patients what they think about how their scar looks seems a fundamental and practical measure of outcome for a scar-specific PRO instrument.

Given content limitations of existing scar-specific PRO instruments, our team created the SCAR-Q. In this article, we describe the various steps taken to develop this new PRO instrument.

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