Establishing content validity of the CLEFT-Q: A new patient-reported outcome instrument for CLEFT lip/palate

Elena Tsangaris, Karen W.Y.Wong Riff, Tim Goodacre, Christopher R. Forrest, Marieke Dreise, Jonathan Sykes, Tristan De Chalain, Karen Harman, Aisling O'Mahony, Andrea L. Pusic, Lehana Thabane, Achilleas Thoma, Anne F. Klassen

Research output: Contribution to journalArticlepeer-review

34 Scopus citations


Background: The CLEFT-Q is a new patient-reported outcome instrument designed to measure outcomes that matter to patients. The aim of this qualitative study was to establish content validity of the CLEFT-Q in patients who differ by age and culture. Methods: Patients aged between 6 and 29 years were recruited from plastic surgery clinics in Canada, India, Ireland, the Philippines, The Netherlands and the United States. Healthcare providers and other experts participated in a focus group or provided individual feedback. Input was sought on all aspects of the CLEFT-Q (item wording, instructions, and response options), and to identify missing content. Patient interviews and expert feedback took place between September 2013 and September 2014. Results: Sixty-nine patients and 44 experts participated. The first draft of the CLEFT-Q consisted of 163 items measuring 12 constructs. The first round of feedback identified 92 items that required revision. In total, 3 rounds of interviews, and the involvement of an artist to create pictures for 17 items, were needed to establish content validity. At the conclusion of cognitive interviews, the CLEFT-Q consisted of 13 scales (total 171 items) that measure appearance, health-related quality of life, and facial function. The mean Flesch-Kincaid readability statistic for items was 1.4 (0 to 5.2). Conclusion: Cognitive interviews and expert review allowed us to identify items that required re-wording, re-conceptualizing, or to be removed, as well as any missing items. This process was useful for refining the CLEFT-Q scales for further testing.

Original languageEnglish (US)
Article numbere1305
JournalPlastic and Reconstructive Surgery - Global Open
Issue number4
StatePublished - Jan 1 2017

ASJC Scopus subject areas

  • Surgery


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