FACE-Q KIDS PROM Study
Research type
Research Study
Full title
An International Study to Develop a Patient-Reported Outcome Instrument for Children and Youth with Facial Differences: The FACE-Q KIDS
IRAS ID
176828
Contact name
Tim Goodacre
Contact email
Sponsor organisation
Research and Development Department, Oxford University Hospitals
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Visible facial differences in paediatric patients have a significant impact on patient quality of life. An integral component of treatment is aimed at improving appearance, function, and psychosocial well-being, outcomes best evaluated with patient input. To measure the patient perspective, a clinically meaningful patient reported outcome measure (PROM) is needed, but none currently exist for assessing the entire breadth of paediatric facial deformities. Our international team previously developed the CLEFT-Q from 138 patient interviews across six countries, which measures what patients think about their appearance, speech, psychological, social, and physical health. Our team is strategically placed to address other paediatric conditions where PRO instruments are lacking. The aim of this study is to develop a new PRO instrument called FACE-Q KIDS for patients with: acne vulgaris, vascular malformations, congenital melanocytic nevi, burns, ear anomalies, facial asymmetries (e.g., craniosynostosis), and facial paralysis. Participants will be 8 to 29 years old recruited from children’s hospitals in Canada (McMaster Children’s Hospital in Hamilton; Hospital for Sick Children in Toronto), England (Oxford Children’s Hospital in Oxford; Great Ormond Street Hospital in London), and the United States (Inova Hospital for Children in Washington). Phase I of this study includes semi-structured interviews with patients to develop a conceptual framework and set of scales, and cognitive interviews with patients to refine the preliminary set of scales and items ensuring they contain maximum content validity and are easy to comprehend. Phase I will take approximately 2 years to complete.
Summary of Resuts
Our final study results showed that the FACE-Q measured concepts important to patients and worked as expected to measure them. The FACE-Q can now be used in research studies to study outcomes of craniofacial conditions. In addition, the FACE-Q can be used by healthcare providers to better understand the concerns that matter the most to patients. You can learn more about the FACE-Q Craniofacial module at https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbUSAjc6Aq3jgFboXJhZeBtyyhRusFsxtGP5dcEIZnRasy57WDxtMtkeMC7GAnO6kOQ-3D-3DmTEq_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKQvgPKBIfWUKW7FBndy81TKnu5j3iH-2FiqMBahXVR-2FFRU8mv-2BCPq-2FM0HKJfq8d0NQpWNq11hVO5nFdx2GSGEdihCKMLq7awb-2FvG5KQnA8XS2e0Q7PAdqWR4Nx5mbrukezTRYEpL14RRWN7EHcsPMkCgl2qqbZHcjyBVbbrGQ2v3nQ-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7Cec9c8b83af6e435053bc08da1d8e31d6%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637854793801605914%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=CFRr5TyHwxm%2FQrSS0nEwJ7wsOmMirs2JX7JhQIaFTRM%3D&reserved=0 . In the future, other properties of the FACE-Q can be examined, such as how well it can measure change after treatment.REC name
London - Queen Square Research Ethics Committee
REC reference
15/LO/1507
Date of REC Opinion
24 Aug 2015
REC opinion
Favourable Opinion