Cognitive testing of a Patient-Reported Outcome Measure for Cleft Lip and Palate: The Cleft Q
Completed
- Conditions
- cleft lip and palate10027664
- Registration Number
- NL-OMON40315
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
• Children/adolescents with CLP between 8 and 22 years of age.
• 6 participants in the age group 8-12 and 7 in the age group of 13-17 and 18-22 years
• who are under treatment in our cleft centre or
• who had treatment in our centre in the close past
* written informed consent of subject and/or parents/legal representative
*
Exclusion Criteria
• Children with a cognitive disability and/or who cannot read.
• Children who do not understand/speak Dutch.
• Children who have any other congenital syndrome of craniofacial anomaly besides cleft lip and/or palate
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>There are no clear study parameters in this qualitative study. The interviewer<br /><br>will use the cognitive interview guide to probe the child (appendix 2) He/she<br /><br>will record participant*s answers on a computerized spreadsheet.<br /><br>After each interview, the interviewer will complete a summary statement for<br /><br>each item and the child*s comments. After completing all initial cognitive<br /><br>interviews for an item, the interviewer will compile reports that include all<br /><br>comments for an item. The team will review all the comments to determine issues<br /><br>with formatting, item comprehension, instructions, tense and response options.<br /><br>Items deemed problematic by 2 or more children of any age will be revised for<br /><br>clarity. Other items similar to those revised after the initial interview<br /><br>process are also changed to maintain consistency across item stems or wording. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>