Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q

Study Overview
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Brief Summary
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The goal of this observational study is to test the questionnaire CLEFT-Q in a population of patients with cleft lip and/or palate. The main questions it aims to answer are: Are CLEFT-Q scores reliable over time? Can CLEFT-Q detect change following surgical treatment intervention? What is the norm for CLEFT-Q within a control population who do not have cleft lip and/or palate? What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and/or palate? Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention? What are the main expectations that patients express before a surgical intervention? How do patients perceive that the results after surgical interventions meet their expectations? Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q? How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes? Participants will Fill out the questionnaire CLEFT-Q twice with a two-week space. Before and 1 year after an operation. Be interviewed about their experiences related to an operation or using CLEFT-Q. Researchers will compare results from the cleft lip and palate population to see if there is a difference between them and a population without cleft lip and palate.

Official Title
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Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q

Conditions
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Cleft Lip and Palate

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cleft lip and/or palate Planned secondary surgery of the nose, lips, jaw or to improve speech Can speak and read Swedish Exclusion Criteria: Multiple surgeries at once

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Test-retest reliability<br>50 patients answer CLEFT-Q twice with 1-2 weeks in between. | |
| Secondary Nose Surgery<br>50 patients answer CLEFT-Q before and 6 months after secondary nose surgery. | |
| Secondary Lip Surgery<br>50 patients answer CLEFT-Q before and 6 months after secondary lip surgery. | |
| Jaw Surgery<br>50 patients answer CLEFT-Q before and 1 year after jaw surgery. | |
| Secondary Speech Improving Surgery<br>50 patients answer CLEFT-Q before and 1 year after secondary speech improving surgery. | |
| Health care professionals<br>20 health care professionals will be interviewed about their experiences on working with CLEFT-Q. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CLEFT-Q change scores | CLEFT-Q is a questionnaire on health related quality of life specific to patients with cleft lip and palate | At enrollment and after 1-2 weeks, or after 6 months, or after 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photograph | Photographs from before and after surgery | Before surgery and after 6 months or 1 year. | 
| Speech | Recording of speech | Before surgery and after 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLEFT-Q, Psychometrics, Test-retest reliability, Interpretability, Responsiveness