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

Tsangaris, Elena; Riff, Karen W. Y. Wong; Goodacre, Tim; Forrest, Christopher R.; Dreise, Marieke M.; Sykes, Jonathan M.; Chalain, Tristan de; Harman, K. E.; O'Mahony, A; Pusic, Andrea L.; Thabane, Lehana; Thoma, Achilleas; Klassen, Anne F.

doi:10.1097/gox.0000000000001305

Cited by 56 publications

(45 citation statements)

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“…Results from the literature review was used to develop an initial CLEFT-Q conceptual framework that was refined from the qualitative data and used to inform the development of a set of scales [ 30 ]. Revisions to the scales (items, instructions, and response options) were made using feedback from patients during a series of cognitive interviews as well as experts in the field of CL/P [ 31 ].…”

Section: Methodsmentioning

confidence: 99%

“…The field- test version of the CLEFT-Q comprised 154 items distributed across 3 domains and 13 concepts as follows: appearance of the face, nose, nostrils, teeth, lips, jaws, cleft scar; HRQOL, i.e., psychological, social, school, and speech-related distress; and facial function i.e., speaking and eating/drinking [ 31 ]. The 7 appearance scales ask respondents to answer each item thinking of how their face (or specific area of their face) looks now and respondents are then asked to answer for each item “how much do you like…” using the following 4 response options: “Not at all”, “A little bit”, “Quite a bit”, “Very much” [ 31 ]. The HRQOL and facial function scales ask respondents to answer each item in relation to the past week, and in terms of the following frequency response options: “Never”, “Sometimes”, “Often”, “Always” [ 31 ].…”

Section: Methodsmentioning

confidence: 99%

“…The 7 appearance scales ask respondents to answer each item thinking of how their face (or specific area of their face) looks now and respondents are then asked to answer for each item “how much do you like…” using the following 4 response options: “Not at all”, “A little bit”, “Quite a bit”, “Very much” [ 31 ]. The HRQOL and facial function scales ask respondents to answer each item in relation to the past week, and in terms of the following frequency response options: “Never”, “Sometimes”, “Often”, “Always” [ 31 ]. Mean Flesch–Kincaid (F–K) grade-reading level for the CLEFT-Q items was 1.4 (range, 0–5.2), most of which were below the fifth-grade reading level, with the exception of 2 items [ 31 ].…”

Section: Methodsmentioning

confidence: 99%

“…The HRQOL and facial function scales ask respondents to answer each item in relation to the past week, and in terms of the following frequency response options: “Never”, “Sometimes”, “Often”, “Always” [ 31 ]. Mean Flesch–Kincaid (F–K) grade-reading level for the CLEFT-Q items was 1.4 (range, 0–5.2), most of which were below the fifth-grade reading level, with the exception of 2 items [ 31 ].…”

Section: Methodsmentioning

confidence: 99%

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Translation and cultural adaptation of the CLEFT-Q for use in Colombia, Chile, and Spain

Tsangaris

Riff

Vargas³

et al. 2017

Health Qual Life Outcomes

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BackgroundCleft lip and/or palate (CL/P) is a common congenital craniofacial anomaly that may negatively affect an individual’s appearance, health-related quality of life, or speech. In Spain, Colombia, and Chile the overall prevalence of CL/P ranges from 0.53 to 1.59 cases per 1000 live births. Currently, there is no patient-reported outcome (PRO) instrument that is specific for patients with CL/P. The CLEFT-Q is a new PRO instrument developed to measure outcomes of treatment in patients 8 to 29 years of age with CL/P. The aim of this study was to translate and culturally adapt the CLEFT-Q for use in Colombia, Chile, and Spain.MethodsThe CLEFT-Q was translated from English to 3 Spanish language varieties (Colombian, Chilean, and Spanish (Spain)) and Catalan. Translation and cultural adaptation guidelines set forth by the International Society for Pharmacoeconomics and Outcomes Research were followed.ResultsThe field- test version of the CLEFT-Q consisted of 13 scales (total 154 items) measuring appearance, health-related quality of life, and facial function. Forward translations revealed 10 (7%) items that were difficult to translate into Chilean, and back translations identified 34 (22%) and 21 (13%) items whose meaning differed from the English version in at least 1 of the 3 Spanish varieties and Catalan respectively. Twenty-one participants took part in cognitive debriefing interviews. Participants were recruited from plastic surgery centres in Bogotá, Colombia (n = 4), Santiago, Chile (n = 7), and Barcelona, Spain (n = 10). Most participants were males (n = 14, 67%) and were diagnosed with CL/P (n = 17, 81%). Participants reported difficulty understanding 1 item in the Colombian, 1 item in the Spanish (Spain), and 11 items from the Catalan version. Comparison of the 3 Spanish varieties revealed 61 (40%) of the 154 items whose wording differed across the 3 Spanish versions.ConclusionTranslation and cultural adaptation processes provided evidence of transferability of the CLEFT-Q scales into 3 Spanish varieties and Catalan, as semantic, idiomatic, experiential, and conceptual equivalence of the items, instructions, and response options were achieved.Electronic supplementary materialThe online version of this article (10.1186/s12955-017-0805-7) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Translation and cultural adaptation of the CLEFT-Q for use in Colombia, Chile, and Spain

Tsangaris

Riff

Vargas³

et al. 2017

Health Qual Life Outcomes

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“…6 , 10-12 , 14-16 This approach of data collection is particularly appealing in the case of the CLEFT-Q, which has a total of 110 items if all scales are used and is intended for children as young as 8 years old. 17 CATs can be administered on computers or electronic tablets with an engaging user interface, and results are uploaded instantly to a secure server. They have the potential to provide realtime graphical feedback on performance in an easily interpretable format.…”

Section: Introductionmentioning

confidence: 99%

Computerised adaptive testing accurately predicts CLEFT-Q scores by selecting fewer, more patient-focused questions

Harrison

Geerards

Ottenhof

et al. 2019

Journal of Plastic, Reconstructive & Aesthetic Surgery

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Background: The International Consortium for Health Outcome Measurement (ICHOM) has recently agreed upon a core outcome set for the comprehensive appraisal of cleft care, which puts a greater emphasis on patient-reported outcome measures (PROMs) and, in particular, the CLEFT-Q. The CLEFT-Q comprises 12 scales with a total of 110 items, aimed to be answered by children as young as 8 years old. Objective: In this study, we aimed to use computerised adaptive testing (CAT) to reduce the number of items needed to predict results for each CLEFT-Q scale. Method: We used an open-source CAT simulation package to run item responses over each of the full-length scales and its CAT counterpart at varying degrees of precision, estimated by standard error (SE). The mean number of items needed to achieve a given SE was recorded for Conflicts of Interest: The CLEFT-Q is owned by McMaster University and The Hospital for Sick Children, and it was developed by Anne Klassen and Karen Wong Riff. The CLEFT-Q can be used free of charge for non-profit purposes (e.g. by clinicians, researchers and students). The other authors declare no potential conflicts of interest with regard to the research, authorship and publication of this article.

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Patient-Reported Outcome Measures as Driving Factors to Transform Surgical Cleft Care

Denadai¹,

Lo²

2022

Current Concept in Cleft Surgery

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

Abstract: Supplemental Digital Content is available in the text.

Cited by 56 publications

References 42 publications

Translation and cultural adaptation of the CLEFT-Q for use in Colombia, Chile, and Spain

Translation and cultural adaptation of the CLEFT-Q for use in Colombia, Chile, and Spain

Computerised adaptive testing accurately predicts CLEFT-Q scores by selecting fewer, more patient-focused questions

Patient-Reported Outcome Measures as Driving Factors to Transform Surgical Cleft Care

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