To contribute to completion of the psychometric development of the Cleft Q
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome of the study: An internationally validated PROM for use by patients
with cleft lip and/or palate.
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 Candada, USA and UK has taken up the challenge and is developing this PRO
instrument, called the CLEFT-Q. The UMCG, MCL , UMCU, ErasmusMC and VUMC will
participate in testing the dutch version of the CLEFT-Q.
Study objective
To contribute to completion of the psychometric development of the Cleft Q
Study design
Psychometric study that involves qualitative and quantitative methods,
following international guidelines and criteria for the development of a PROM
Study burden and risks
To implement the study there is no other way than to test the CLEFT-Q on the
target group. This group consists partly f minors (WMO, art4 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
imcompetent adults: "no-unless" and "Code of conduct concerning objection of
minors who take part in medical scientific research". There is no benefit to
the subject directly but the outcomes of the study will halp future patients
who face the same problems as the subject and improve treatment an care,
deleiberd through the specialized cleft teams in and outside the Netherland.
Therefore we feel that the burden to the pattient will be in proportion to the
potential value of the study.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
* Children/adolescents with CL, CP, CLP between 6 and 29 years of age.
* Who gave written informed consent (and/or their parents in case of minors)
* who are under treatment in our centres or
* who had treatment in our centres in the past:
Exclusion criteria
* Children with a cognitive disability and/or who cannot read.
* Children who do not understand/speak Dutch.
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 | NL51703.042.14 |
| Other | number not yet received. |