Clinical trial NCT06918392: Field-test and Psychometric Validation of the Pectus Excavatum Evaluation Questionnaire in the Dutch Pectus Excavatum Population
Official title: Field-test and Psychometric Validation of the Pectus Excavatum Evaluation Questionnaire in the Dutch Pectus Excavatum Population
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pectus Excavatum
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 66
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be identified and enrolled during their preoperative visit at the outpatient clinic of Zuyderland Medical Center by a member of the research team.

Brief summary: A questionnaire that can measure disease severity from the patients perspective in patients with pectus excavatum already exists in English (Pectus Excavatum Evaluation Questionnaire; PEEQ). This questionnaire was recently translated into Dutch. Before this Dutch version can be used, it needs to be tested by a number of patients.

Data will be collected at three moments:

1. Preoperatively: The PEEQ will be completed on paper during the outpatient clinic visit.
2. Postoperatively: The PEEQ will be completed electronically 2 months post-surgery.
3. Test-retest reliability: The PEEQ will be administered electronically at least two weeks after a previous assessment.


Eligibility criteria: Inclusion Criteria:

* Eligible participants will be pectus excavatum patients aged 12 to 18 years old who are scheduled for a Nuss procedure. Parents or legal guardians will also be invited to complete the parent section of the PEEQ.

Exclusion Criteria:

* Exclusion criteria will be the inability of the patient or their parent/guardian to complete the corresponding section of the questionnaire due to language barriers.

Primary outcomes:
measure: Structural validity
timeFrame: Pre-operative assessment of pectus excavatum evaluation questionnaire at the outpatient clinic visit. Minimum score of this questionnaire is 22, maximum score is 88, a higher score indicates a lower disease-related quality of life.
measure: Internal consistency
timeFrame: Pre-operative assessment of pectus excavatum evaluation questionnaire at the outpatient clinic visit. Minimum score of this questionnaire is 22, maximum score is 88, a higher score indicates a lower disease-related quality of life.
measure: Test-retest reliability
timeFrame: Pre-operative assessment of pectus excavatum evaluation questionnaire OR the 2 months postoperative assessment will be used as a baseline. Another assessment wil be performed minimally 2 weeks after one of the aforementioned assessments.
measure: Responsiveness
timeFrame: re-operative assessment of pectus excavatum evaluation questionnaire at the outpatient clinic visit. Minimum score of this questionnaire is 22, maximum score is 88, a higher score indicates a lower disease-related quality of life.
measure: Smallest detectable change
timeFrame: Pre-operative assessment of pectus excavatum evaluation questionnaire and two months postoperative assessment. Minimum score of this questionnaire is 22, maximum score is 88, a higher score indicates a lower disease-related quality of life.
Secondary outcomes:
measure: Floor and ceiling effects
timeFrame: Pre-operative assessment of pectus excavatum evaluation questionnaire and two months postoperative assessment. Minimum score of this questionnaire is 22, maximum score is 88, a higher score indicates a lower disease-related quality of life.
Other outcomes:
Locations:
Study officials:
References:
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