Menu
Recruiting NCT06918392

Field-test and Psychometric Validation of the Pectus Excavatum Evaluation Questionnaire in the Dutch Pectus Excavatum Population

— Observational Pectus Excavatum

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pectus Excavatum. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Structural validity [Time frame: 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.]
  • Internal consistency [Time frame: 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.]
  • Test-retest reliability [Time frame: 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.]
  • Responsiveness [Time frame: 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.]
  • Smallest detectable change [Time frame: 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 outcome measures (1)
  • Floor and ceiling effects [Time frame: 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Zuyderland Medical Center — Heerlen

Publications

  • Janssen N, Daemen JHT, van Polen EJ, Coorens NA, Jansen YJL, Franssen AJPM, Hulsewe KWE, Vissers YLJ, Haecker FM, Milanez de Campos JR, de Loos ER; Chest Wall International Group Collaborator Group. Pectus Excavatum: Consensus and Controversies in Clinical Practice. Ann Thorac Surg. 2023 Jul;116(1):191-199. doi: 10.1016/j.athoracsur.2023.02.059. Epub 2023 Mar 29. PMID 36997016
  • Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24. PMID 17161752
  • Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74. PMID 843571
  • Cicchetti D V. Guidelines, criteria, and rules of thumb for evaluating normed and standardized assessment instruments in psychology. Psychol Assess. 1994;6:284-90.
  • Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. doi: 10.1037//0033-2909.86.2.420. PMID 18839484
  • Fayers PM. Quality of life : The assessment, analysis, and reporting of patient-reported outcomes. 3rd ed. Chichester: Wiley Blackwell; 2016.
  • Schreiber JB, Nora A, Stage FK, Barlow EA, King J. Reporting Structural Equation Modeling and Confirmatory Factor Analysis Results: A Review. J Educ Res. 2006;99:323-38
  • Kline P. An Easy Guide to Factor Analysis. 1st ed. New York: Routledge; 2014.

Identifiers

NCT: NCT06918392 · Z2021173

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗