Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q (CLEFT-QSwePsyc)

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:

1. Are CLEFT-Q scores reliable over time?
2. Can CLEFT-Q detect change following surgical treatment intervention?
3. What is the norm for CLEFT-Q within a control population who do not have cleft lip and/or palate?
4. What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and/or palate?
5. Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention?
6. What are the main expectations that patients express before a surgical intervention?
7. How do patients perceive that the results after surgical interventions meet their expectations?
8. Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q?
9. How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes?

Participants will

1. Fill out the questionnaire CLEFT-Q twice with a two-week space.
2. Before and 1 year after an operation.
3. 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.

Study Overview

• Status: Recruiting
• Conditions: Cleft Lip and Palate

• Study Type: Observational
• Enrollment (Anticipated): 260

Contacts and Locations

• Study Contact: Name: Mia Stiernman, MD PhD; Phone Number: +46737032606; Email: mia.stiernman@med.lu.se

Study Locations

• Sweden
  • Skania
    • Malmö, Skania, Sweden
      • Recruiting
      • Skania University Hospital
      • Contact: Mia Stiernman, MD PhD; Phone Number: +46737032606; Email: mia.stiernman@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 29 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

- Patients with cleft lip and/or palate who have been operated as infants and opt for secondary surgery to improve appearance, occlusion or speech.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Department of Plastic and Reconstructive Surgery
• Collaborators: Karolinska University Hospital; Uppsala University Hospital; Linköping Univeristy Hospital; Umeå University Hospital
• Investigators: Principal Investigator: Mia Stiernman, MD PhD, Mia Stiernman

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Psychometrics; Responsiveness; Test-retest reliability; CLEFT-Q; Interpretability
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: 2021-06993-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No