Psychometric Validation of the CLEFT-Q Patient Reported Outcome Measure: A Prospective Study to Examine Cross-Sectional Construct Validity

• Published in: The Cleft palate-craniofacial journal Vol. 60; no. 3; pp. 327 - 335
• Main Authors: Miroshnychenko, Anna, Rae, Charlene, Riff, Karen Wong, Forrest, Christopher, Goodacre, Tim, Swan, Marc, Slator, Rona, Goldstein, Jesse, Thoma, Achilleas, Harman, Karen, Klassen, Anne
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01-03-2023; SAGE PUBLICATIONS, INC
• Subjects: Birth defects; Child; Cleft Lip - psychology; Cleft Lip - surgery; Cleft Palate - psychology; Cleft Palate - surgery; Cross-Sectional Studies; Female; Humans; Hypotheses; Male; Original; Patient Reported Outcome Measures; Patients; Prospective Studies; Psychometrics; Quality of Life; Quantitative psychology; Validation studies; Validity; orthognathic surgery; quality of life; rhinoplasty; bone grafting
• ISSN: 1055-6656; 1545-1569
• DOI: 10.1177/10556656211062837

Objective
CLEFT-Q is a condition-specific patient-reported outcome measure (PROM) for patients with cleft lip and/or palate (CL/P). The aim of this study was to examine the cross-sectional construct validity of the CLEFT-Q scales.
Design
Construct validity was assessed through a prospective study that tested hypotheses regarding correlations of scores with other PROMs that measure related constructs.
Setting
Seven cleft centres in Canada, the USA, and UK were involved.
Patients/Participants
Patients were aged eight to 29 years with CL/P.
Interventions
Before undergoing rhinoplasty, orthognathic, cleft lip scar revision, and alveolar bone graft, participants were asked to complete the following PROMs: CLEFT-Q (9 scales), Child Oral Health Impact Profile (socio-emotional subscale) and Cleft Hearing Appearance and Speech Questionnaire (features 1 subscale).
Main Outcome Measure(s)
The correlation coefficients examining the relationship between the scales were the main outcome measures. Correlations (Spearman) were calculated and interpreted as follows: <0.3 weak, 0.30 to 0.50 moderate, ≥0.50 strong.
Results
Participants (n = 177) were mostly male (61%) and aged between eight and 11 years (42%). Overall, 38 of 52 (73%) hypotheses tested were supported. More specifically, 20 of 26 (77%) hypotheses about correlations between the appearance scales were supported, two of three (67%) hypotheses about correlations between the health-related quality of life scales were supported, and 16 of 23 (70%) hypotheses about correlations between the appearance and health-related quality of life scales were supported.
Conclusions
Cross-sectional construct validity of the CLEFT-Q scales adds further evidence of the psychometric properties of this instrument.