New concepts elicited.

PurposeThis study aimed to assess and modify the content of the FACE-Q Craniofacial Module, an appearance-based patient-reported outcome measure to address the lack of validated measures for use in retinoblastoma survivors.MethodsThis cross-sectional qualitative content validity study was conducted at the Hospital for Sick Children. Through purposive sampling, survivors (8 years old or older) and parents of ineligible survivors participated in cognitive debriefing interviews from February 2022 to February 2024. Participants provided suggestions regarding comprehensibility, comprehensiveness, and relevance of the FACE-Q Craniofacial Module to the retinoblastoma experience. Interviews continued until saturation. The suggestions were presented to a panel of clinicians, scientists, and patient advocates to make iterative modifications.ResultsSurvivor participants (n = 14) and parent participants (n = 15) enrolled to the study. The mean age of participants was 20.3 and 40 years for survivors and parents respectively. The FACE-Q Craniofacial Module was modified with the revision of ten items, addition of eleven items, and removal of three items, with the Social Function (n = 7) and Appearance Distress (n = 5) scales requiring the most modifications. A novel scale of 17 items was also developed to assess the appearance of survivors who wear a prosthetic eye with input from 10 patients and 6 parents.ConclusionsThe FACE-Q Craniofacial Module may be suitable to adapt for retinoblastoma survivors. The modifications resulting from this study ensure the tool comprehensively captures retinoblastoma-specific concerns, facilitating holistic and patient-centred clinical assessment and research. The next step in the adaptation of the FACE-Q Craniofacial Module is to psychometrically validate the modified version to ascertain its reliability and validity.