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Establishing Content Validity of the CLEFT-Q: A New Patient-reported Outcome Instrument for Cleft Lip/Palate
Elena Tsangaris1, Karen W Y Wong Riff1, Tim Goodacre1
1Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Surgery, Division of Plastic and Reconstructive Surgery, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada; Department of Plastic Surgery, Spires Cleft Center, Oxford Radcliffe Children's Hospital, Oxford, United Kingdom; Department of Plastic Surgery, University of Groningen, Groningen, the Netherlands; Department of Otolaryngology/Facial Plastic Surgery, UC Davis Health System, Sacramento, Calif.; Auckland Plastic Surgical Centre, Auckland, New Zealand; Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada; Department of Cleft Orthodontic/Prosthodontic, St. James Hospital, Dublin, Ireland; Department of Plastic and Reconstructive Surgery, Memorial Sloan-Kettering Cancer Center, New York, N.Y.; Department of Surgery, Division of Plastic Surgery, McMaster University, Hamilton, Ontario, Canada; and Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.
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.
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