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CLEFT-Q SwePsych protocol: A prospective observational study to investigate the psychometric characteristics test-retest reliability, responsiveness, and interpretability of CLEFT-Q

Stiernman, Mia LU ; Klintö, Kristina LU orcid ; Wiedel, Anna-Paulina LU ; Schaar Johansson, Malin LU orcid ; Cornefjord, Måns LU orcid ; Schönmeyr, Björn ; Stålhand, Gudrun ; Korduner, Mikael ; Bengtsson, Martin LU orcid and Mani, Maria , et al. (2025) In PLoS ONE 20(5). p.1-11
Abstract
Objectives
Patient perceived benefit of treatment for cleft lip and/or palate is of great importance since it is central to development of cleft care. CLEFT-Q is a cleft-specific questionnaire on health-related quality of life. Test-retest reliability, aspects of responsiveness and interpretability are yet to be established for CLEFT-Q. This study aims to investigate these psychometric characteristics of CLEFT-Q.

Methods
To establish the test-retest reliability of CLEFT-Q, data will be collected repeatedly and independently at approximately 1-week intervals. Inclusion of approximately 50 patients is considered adequate for a test-retest study. To improve the interpretability of CLEFT-Q norm data from a control population... (More)
Objectives
Patient perceived benefit of treatment for cleft lip and/or palate is of great importance since it is central to development of cleft care. CLEFT-Q is a cleft-specific questionnaire on health-related quality of life. Test-retest reliability, aspects of responsiveness and interpretability are yet to be established for CLEFT-Q. This study aims to investigate these psychometric characteristics of CLEFT-Q.

Methods
To establish the test-retest reliability of CLEFT-Q, data will be collected repeatedly and independently at approximately 1-week intervals. Inclusion of approximately 50 patients is considered adequate for a test-retest study. To improve the interpretability of CLEFT-Q norm data from a control population of volunteers without a cleft will be collected. A total of approximately 210 participants will be included from schools, high-schools and universities. To test the responsiveness of CLEFT-Q, patients will answer selected subscales of CLEFT-Q, longitudinal anchor questions and perform global ratings of change before and after surgery. To ensure robust results, approximately 50 patients for each type of treatment will be recruited. If CLEFT-Q is found to be responsive, the pre- and postoperative difference in scores of CLEFT-Q will be compared with the change in objective measurements based on assessments by professionals in cleft care obtained in this study. To evaluate interpretability, results will be analysed to investigate the minimal important change using anchor-based, distribution-based and qualitative approach.

Registration details
This study is registered at ClinicalTrials.gov under the ID 2021-06993-01. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
PLoS ONE
volume
20
issue
5
article number
e0321021
pages
1 - 11
publisher
Public Library of Science (PLoS)
external identifiers
  • scopus:105004763014
  • pmid:40334197
ISSN
1932-6203
DOI
10.1371/journal.pone.0321021
language
English
LU publication?
yes
id
dc3da4bf-ca53-449f-b4ea-4b41639b123b
date added to LUP
2025-06-10 14:53:47
date last changed
2025-06-12 03:34:03
@article{dc3da4bf-ca53-449f-b4ea-4b41639b123b,
  abstract     = {{Objectives<br/>Patient perceived benefit of treatment for cleft lip and/or palate is of great importance since it is central to development of cleft care. CLEFT-Q is a cleft-specific questionnaire on health-related quality of life. Test-retest reliability, aspects of responsiveness and interpretability are yet to be established for CLEFT-Q. This study aims to investigate these psychometric characteristics of CLEFT-Q.<br/><br/>Methods<br/>To establish the test-retest reliability of CLEFT-Q, data will be collected repeatedly and independently at approximately 1-week intervals. Inclusion of approximately 50 patients is considered adequate for a test-retest study. To improve the interpretability of CLEFT-Q norm data from a control population of volunteers without a cleft will be collected. A total of approximately 210 participants will be included from schools, high-schools and universities. To test the responsiveness of CLEFT-Q, patients will answer selected subscales of CLEFT-Q, longitudinal anchor questions and perform global ratings of change before and after surgery. To ensure robust results, approximately 50 patients for each type of treatment will be recruited. If CLEFT-Q is found to be responsive, the pre- and postoperative difference in scores of CLEFT-Q will be compared with the change in objective measurements based on assessments by professionals in cleft care obtained in this study. To evaluate interpretability, results will be analysed to investigate the minimal important change using anchor-based, distribution-based and qualitative approach.<br/><br/>Registration details<br/>This study is registered at ClinicalTrials.gov under the ID 2021-06993-01.}},
  author       = {{Stiernman, Mia and Klintö, Kristina and Wiedel, Anna-Paulina and Schaar Johansson, Malin and Cornefjord, Måns and Schönmeyr, Björn and Stålhand, Gudrun and Korduner, Mikael and Bengtsson, Martin and Mani, Maria and Hakelius, Malin and Peroz, Roshan and Johan, Zötterman and Cajander, Jenny and Mats, Sjöström and Weinfeld, Justin and Christina, Persson and Harrison, Conrad and Allori, Alexander and Miroshnychenko, Anna and Becker, Magnus}},
  issn         = {{1932-6203}},
  language     = {{eng}},
  month        = {{05}},
  number       = {{5}},
  pages        = {{1--11}},
  publisher    = {{Public Library of Science (PLoS)}},
  series       = {{PLoS ONE}},
  title        = {{CLEFT-Q SwePsych protocol: A prospective observational study to investigate the psychometric characteristics test-retest reliability, responsiveness, and interpretability of CLEFT-Q}},
  url          = {{http://dx.doi.org/10.1371/journal.pone.0321021}},
  doi          = {{10.1371/journal.pone.0321021}},
  volume       = {{20}},
  year         = {{2025}},
}