Patient reported outcome measures for facial skin cancer: a systematic review and evaluation of the quality of their measurement properties Tom Dobbs, Harsh Samarendra, Sarah Hughes, Hayley Hutchings, Iain S Whitaker Welsh Centre for Burns and Plastics Swansea University Medical School Oxford University Medical School British Journal of Dermatology. DOI: 10.1111/bjd.17342

Mr Tom Dobbs

Introduction What is already known about this topic? Patient-reported outcome measures (PROMs) are important in both research and daily clinical practice. This is especially true in facial skin cancer, where both the condition and the resulting aesthetic outcome of treatment are important. PROMs for facial skin cancer exist, however their validity against the contemporary international consensus have yet to be reported. The relevance of these PROMs to patients’ views of treatment outcomes is yet to be investigated.

Objectives Identify PROMs that have been designed for and/or validated in patients with facial skin cancer Assess the methodological quality of the included studies Assess the psychometric properties of those identified PROMs Make an assessment of the focus of each PROM on the reconstructive aspect of patient care

Methods (1) Systematic review to identify PROMs for facial skin cancer MEDLINE, EMBASE, PsychINFO, Cochrane and CINAHL searched Abstracts screened using inclusion and exclusion criteria by two reviewers

Methods (2) Methodological quality of included studies assessed using the COnsenus- based Standards for the Selection of Health Measurement INstruments (COSMIN) Psychometric properties of included studies assessed using criteria developed by Terwee et al Combination of these used to develop best evidence summary Assessment of relevance to reconstruction of skin cancer also assessed

Fig. 1 – PRISMA flow-diagram Results (1) Fig. 1 – PRISMA flow-diagram 24 studies on 11 PROMs included (Fig. 1)

Results (2) Fig. 2 – Best evidence summary of results from COSMIN and Terwee et al assessment. OMERACT recommendation: instrument meets two or more required items and therefore has potential for use

Results (3) Patient Outcome of Surgery – Head/Neck (POS-H/N), Skin Cancer Index (SCI), Skin Cancer Quality of Life Impact Tool (SCQLIT) and Essers et al demonstrating the greatest level of validation (Fig. 2) None scored well in terms of relevant questions to post- treatment reconstruction

Discussion (1) Identified PROMs had a variable degree of validation against current international best standards Four show potential, with reasonably good validation already completed A fifth (FACE-Q Skin Cancer module) has potential but at the time of systematic review very little had been published on it

Discussion (2) All showed little relevance in their questions to the aesthetic and functional aspects of reconstruction This needs to be addressed and further validation performed before routine use of a PROM for facial skin cancer can be recommended

Conclusions What does this study add? This systematic review provides a comprehensive assessment of the validity of PROMs used for facial skin cancer using current best practice assessment tools, helping clinicians and researchers to select the most appropriate PROM to use. Each PROM is also assessed for relevance to the post-treatment aesthetic outcome, with a recommendation that further validated items are required to adequately assess this important area of skin cancer treatment.

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