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Copyright 15-083


Cleft lip and/or palate is estimated to be the most common congenital craniofacial abnormality, with an incidence of approximately 7.9 clefts per 10,000 live births annually. These conditions present with an abnormal connection between the mouth and the nose that can be visible on the lip – or invisible, affecting the palate alone.


Cleft left lip and/or palate patients often undergo numerous procedures to improve appearance, speech, dentition and hearing. In order to facilitate rigorous international measurement and benchmarking, Dr. Anne Klassen at McMaster University along with Dr. Karen Wong developed the CLEFT-Q.

This instrument is designed for patients with cleft lip and/or palate aged 8 to 29 years. The CLEFT-Q consists of 13 independently functioning scales/checklists measuring the following concepts: facial appearance (ie. face, nose, nostrils, teeth, lips, cleft scar, jaws), facial function (ie. speech, eating/drinking), and quality of life (ie. speech distress, psychological, social, school function). Each CLEFT-Q scale is composed of a series of items, or questions, that together evaluate a unidimensional construct.

The CLEFT-Q is a self-report tool intended to be answered independently by patients themselves, without interpretation by the parent(s) or healthcare provider. The CLEFT-Q is utilized in academic research and observational studies. It can also be used to collect and compare evidence-based data outcomes. The instrument has been licensed out worldwide and 11 validated translations are available.

To meet increasing demand for electronic versions of questionnaires, the CLEFT-Q is available in electronic format as well as in hardcopy. MILO is also continuing to increase the portfolio of validated translations for questionnaires.

Therapeutic Areas

  • Cleft palate
  • Cleft lip
  • Cleft lip and alveolus


  • Academic studies
  • Observational studies
  • PRO instrument


  • 11 validated translations according to ISPOR guidelines
  • Use in hardcopy or electronic


MILO Business Development

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