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Cleft Palate Craniofac J. 2018 Mar;55(3):442-450. doi: 10.1177/1055665617732854. Epub 2017 Dec 14.

What Matters to Patients With Cleft Lip and/or Palate: An International Qualitative Study Informing the Development of the CLEFT-Q.

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1 Division of Plastic and Reconstructive Surgery, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
2 Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
3 Spires Cleft Center, Oxford Radcliffe Children's Hospital, Oxford, United Kingdom.
4 Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA.
5 Plastic and Reconstructive Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
6 Department of Pediatrics, McMaster University, Hamilton, Canada.



The goal of treatment for individuals with cleft lip and/or palate (CL/P) is to improve physical, psychological, and social health. Outcomes of treatment are rarely measured from the patient's perspective. The aim of the study was to develop a conceptual framework for a patient-reported outcome (PRO) instrument for individuals with clefts (CLEFT-Q) by developing an in-depth understanding of issues that individuals consider to be important.


The qualitative methodology of interpretive description was used. Setting, Participants, and Intervention: We performed 136 individual in-depth interviews with participants with clefts of any age, presenting for cleft care, across 6 countries. Parents were involved if the child was more comfortable. Interviews were audio-recorded, transcribed verbatim, and coded using constant comparison. The data were used to develop a refined conceptual framework.


Participants described concepts of interest in 3 top-level domains, each of which included subdomains: appearance (face, nose, nostrils, teeth, lips, jaw, cleft lip scar), health-related quality of life (psychological, social, school, speech-related distress), and facial function (speech, eating/drinking). Participants were able to describe changes over time with regard to the 3 domains.


A conceptual framework of concepts of interest to individuals with CL/P formed the basis of the scales in the CLEFT-Q. Each subdomain represents an independently functioning scale. Understanding what matters to patients is essential in guiding PRO measurement.


cleft lip and/or palate; interpretive description; patient-reported outcomes; qualitative


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