Cognitive testing of a Patient-Reported Outcome Measure for Cleft Lip and Palate: The Cleft Q

Cognitive testing of a Patient-Reported Outcome Measure for Cleft Lip and Palate: The Cleft Q - Testing the CLEFT-Q

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40315

Enrollment

Registered

2014-03-19

Start date

2014-05-02

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cleft lip and palate

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
There are no clear study parameters in this qualitative study. The interviewer will use the cognitive interview guide to probe the child (appendix 2) He/she will record participants answers on a computerized spreadsheet. After each interview, the interviewer will complete a summary statement for each item and the childs comments. After completing all initial cognitive interviews for an item, the interviewer will compile reports that include all comments for an item. The team will review all the comments to determine issues with formatting, item comprehension, instructions, tense and response options. Items deemed problematic by 2 or more children of any age will be revised for clarity. Other items similar to those revised after the initial interview process are also changed to maintain consistency across item stems or wording.	—

Measure

Time frame

There are no clear study parameters in this qualitative study. The interviewer will use the cognitive interview guide to probe the child (appendix 2) He/she will record participant*s answers on a computerized spreadsheet. After each interview, the interviewer will complete a summary statement for each item and the child*s comments. After completing all initial cognitive interviews for an item, the interviewer will compile reports that include all comments for an item. The team will review all the comments to determine issues with formatting, item comprehension, instructions, tense and response options. Items deemed problematic by 2 or more children of any age will be revised for clarity. Other items similar to those revised after the initial interview process are also changed to maintain consistency across item stems or wording.

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Countries

Netherlands

Outcome results