"Impact of Completing Face-Q Craniofacial Module Scales on Children and Young Adults with Facial Differences: An International Study".

BACKGROUND: The FACE-Q Craniofacial module measures outcomes that matter to patients with diverse craniofacial conditions. However, it is not known whether completing a patient reported outcome measure (PROM) has a negative impact on patients, particularly children. This study aims to investigate the impact of completing the FACE-Q Craniofacial module and identify factors associated with a negative impact. METHODS: Participants were aged 8-29 years, with a facial difference, who completed at least one module of the FACE-Q Craniofacial module as part of the international field-test study between December 2016-2019. Participants were asked three questions: 'Did you like or dislike answering this questionnaire?'; 'Did answering these questions change how you feel about how you look?'; and 'Did answering this questionnaire make you feel unhappy or happy?' Univariate and multivariable logistic regression analyses were used to evaluate variables associated with a negative response. RESULTS: The sample included 927 participants. Most patients responded neutrally to all impact questions: 42.7% neither disliked nor liked the questionnaire; 76.6% felt the same about how they looked; and 72.7% felt neither unhappy/happy after completion. Negative responses represented a small proportion of patients across all three impact questions (<13.2%). Increased craniofacial severity, more scales completed, and lower scores on all FACE-Q scales were associated with negative responses for all three impact questions (p<0.01). CONCLUSION: This study provides evidence that the FACE-Q Craniofacial module is acceptable for most participants. Clinicians and study investigators should follow up with patients after completing this PROM to address areas of concern in scale scores.