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

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

Recruiting
8-29 years
All
Phase N/A

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Overview

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.

Eligibility

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 details
    Cleft Lip and Palate

NCT05775679

Department of Plastic and Reconstructive Surgery

26 January 2024

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