To determine the appropriateness of scale content of the preliminary CLEFT-Q scales by age and culture and to identify unclear or ambiguous items, instructions and response options
ID
Source
Brief title
Condition
- Congenital and hereditary disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Not applicable
Background summary
So far outcomes in cleft treatment have mainly been measured in objective and
biomedical outcomes. Patient perspectives are often overlooked, because an
appropriate, well-defined, valid, reliable and responsive Patient Reported
Outcome measurement tool is not available An international team of experts
from Canada, USA and UK has taken up the challenge and is developing this PRO
instrument, called the CLEFT-Q
Study objective
To determine the appropriateness of scale content of the preliminary CLEFT-Q
scales by age and culture and to identify unclear or ambiguous items,
instructions and response options
Study design
This study is an observational study following recommended guidelines and
criteria for the development of a PRO instrument . The CLEFT-Q scales are
preliminary and need to be refined through cognitive interviewing with
patients. This will involve interviews with patients, asking them to complete
CLEFT-Q scales using the think-aloud-technique, in which patients verbalize
their thoughts as they work through the questionnaire.
Study burden and risks
To implement the study there is no other way than to interview this target
group consisting partly of minors (WMO, art 4, lid 1). The study is group
related, the risks are minimal/negligible and there is no pain and minimal
discomfort. Therefore the study is in line with the codes of conduct as found
on the CCMO website: *Non therapeutic research with minors and legally
incompetent adults: *no-unless* * (12) and *Code of conduct concerning
objection of minors who take part in medical scientific research*.(13)
There is no benefit to the subject directly, but the outcomes of the study will
help future patients who face the same problems as the subject and improve
treatment and care, delivered through the specialized cleft teams in and
outside the Netherlands. Therefore we feel that the burden to the patient will
be in proportion to the potential value of the study
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47560.042.13 |