UK-based prospective cohort study to anglicise and validate the FACE-Q Skin Cancer Module in patients with facial skin cancer undergoing surgical reconstruction: the PROMISCR (Patient-Reported Outcome Measure in Skin Cancer Reconstruction) study

INTRODUCTION: Skin cancer is the most common malignancy worldwide, often occurring on the face, where the cosmetic outcome of treatment is paramount. A number of skin cancer-specific patient-reported outcome measures (PROMs) exist, however none adequately consider the difference in type of reconstruction from a patient’s point of view. It is the aim of this study to ‘anglicise’ (to UK English) a recently developed US PROM for facial skin cancer (the FACE-Q Skin Cancer Module) and to validate this UK version of the PROM. The validation will also involve an assessment of the items for relevance to facial reconstruction patients. This will either validate this new measure for the use in clinical care and research of various facial reconstructive options, or provide evidence that a more specific PROM is required. METHODS AND ANALYSIS: This is a prospective validation study of the FACE-Q Skin Cancer Module in a UK facial skin cancer population with a specific focus on the difference between types of reconstruction. The face and content validity of the FACE-Q questionnaire will initially be assessed by a review process involving patients, skin cancer specialists and methodologists. An assessment of whether questions are relevant and any missing questions will be made. Initial validation will then be carried out by recruiting a cohort of 100 study participants with skin cancer of the face pre-operatively. All eligible patients will be invited to complete the questionnaire preoperatively and postoperatively. Psychometric analysis will be performed to test validity, reliability and responsiveness to change. Subgroup analysis will be performed on patients undergoing different forms of reconstruction postexcision of their skin cancer. ETHICS AND DISSEMINATION: This study has been approved by the West Midlands, Edgbaston Research Ethics Committee (Ref 16/WM/0445). All personal data collected will be anonymised and patient-specific data will only be reported in terms of group demographics. Identifiable data collected will include the patient name and date of birth. Other collected personal data will include their diagnosis, treatment performed, method of reconstruction and complications. A unique identifier will be applied to each patient so that pretreatment and post-treatment questionnaire results can be compared. All data acquisition and storage will be in accordance with the Data Protection Act 1998. Following completion of the study, all records will be stored in the Abertawe Bro Morgannwg University (AMBU) Health Board archive facility. Only qualified personnel working on the project will have access to the data. The outputs from this work will be published as widely as possible in peer-review journals and it is our aim to make this open access.