CLEFT-Q: Detecting Differences in Outcomes among 2434 Patients with Varying Cleft Types.

BACKGROUND: Measuring the patient perspective is important in evaluating outcomes of cleft care. Understanding how treatment outcomes vary depending on cleft type may allow for better planning of treatments, setting of expectations, and more accurate benchmarking efforts. The CLEFT-Q is a patient-reported outcome measure for patients with cleft lip and/or palate. METHODS: The 12 CLEFT-Q scales measuring appearance (i.e., face, nose, nostrils, lips, cleft lip scar, teeth, and jaws), function (i.e., speech), and health-related quality of life (i.e., psychological, school, social, and speech-related distress) were field tested in a cross-sectional study in 30 centers in 12 countries. Patients with cleft lip and/or cleft palate aged 8 to 29 years were recruited from clinical settings. Differences in CLEFT-Q scores by cleft subtypes were evaluated using one-way analysis of variance or Kruskal-Wallis H tests, with Tukey or Dunn procedure with Bonferroni corrections post hoc analyses, respectively. Scores are presented using radar charts to visualize all outcomes simultaneously. RESULTS: The field test included 2434 patients. Scores on all CLEFT-Q scales varied significantly with cleft subtype. Patients with unilateral or bilateral cleft lip and/or palate scored lower on all appearance scales compared with patients with cleft palate or unilateral incomplete cleft lip. Scores on the speech function and speech-related distress scales decreased with each progressive group in the Veau classification. Patients with complete bilateral cleft lip and palate scored lowest on the social, school, and psychological scales. CONCLUSIONS: Patient-reported outcomes measured with the CLEFT-Q vary significantly with cleft type. Visualizing multiple outcomes simultaneously with radar charts allows for an understanding of a patient's overall status in a single graph.

Establishing Content Validity of the CLEFT-Q: A New Patient-reported Outcome Instrument for Cleft Lip/Palate.

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.

Repair of anterior cleft palate fistulae with cancellous bone graft: a simple technique that facilitates dental reconstruction.

BACKGROUND: Cleft palate fistulas of the anterior hard palate following previous repair are a challenging surgical problem. In addition to nasal regurgitation and potential adverse effects on speech, these fistulas may necessitate obturation with a removable dental prosthesis and can mitigate a fixed prosthodontic dental reconstruction. The authors present a method of repair using cancellous bone graft and only native palatal mucosa. METHODS: The authors carried out a retrospective review of 27 consecutive patients who underwent anterior palate fistula repair performed by a single surgeon over an 8-year period. RESULTS: The authors performed 29 fistula closure procedures using cancellous bone on 27 consecutive patients. Twenty-three (85 percent) of the initial 27 palatal fistula repairs in this study resulted in complete closure of the fistula. Two of the four patients who had incomplete closure went on to have a second operation using exactly the same technique, and complete closure was achieved. The remaining two patients in whom only partial closure was achieved were asymptomatic and no further treatment was necessary. All patients had an improvement in fistula symptoms after surgery. All patients who were using removable dentures/obturators were restored with fixed dental restorations supported by osseointegrated implants or fixed conventional bridges. CONCLUSIONS: This relatively simple method achieves reliable closure of most anterior hard palate fistulas and can be repeated if necessary. This technique removes the necessity of obturation of the defect with a removable prosthesis and in some cases facilitates the placement of dental implants.