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

Department of Plastic and Reconstructive Surgery

Status: Enrolling

Conditions: Cleft Lip and Palate

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT05775679

2021-06993-01

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 8 to 29 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

260 participants in 6 patient groups

Test-retest reliability

Description:

50 patients answer CLEFT-Q twice with 1-2 weeks in between.

Secondary Nose Surgery

Description:

50 patients answer CLEFT-Q before and 6 months after secondary nose surgery.

Secondary Lip Surgery

Description:

50 patients answer CLEFT-Q before and 6 months after secondary lip surgery.

Jaw Surgery

Description:

50 patients answer CLEFT-Q before and 1 year after jaw surgery.

Secondary Speech Improving Surgery

Description:

50 patients answer CLEFT-Q before and 1 year after secondary speech improving surgery.

Health care professionals

Description:

20 health care professionals will be interviewed about their experiences on working with CLEFT-Q.