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

March 23, 2026 updated by: Erik de Loos

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pectus excavatum patients
pectus excavatum patients aged 12 to 18 years old who are scheduled for a Nuss procedure, and their parents or legal guardians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
A Kaiser-Meyer-Olkin (KMO) test and Bartlett's test of sphericity are performed to assess the adequacy of patient sampling before performing further structural tests. Threshold values of ≥ 0.70 in KMO test and p < 0.05 in Bartlett's test of sphericity indicate the suitability of the collected data for factor analysis (6,7). Exploratory factor analysis (EFA), using principal axis factoring and a promax rotation method, will be conducted to identify the underlying factor structure for both the child and parent sections (8,9). These factor structures will later be subjected to confirmatory factor analysis (CFA), using polychoric correlations and robust maximum likelihood estimation, to evaluate the validity of the structures derived from EFA (8,10). Within EFA, the Kaiser criterion (eigenvalue > 1), explained variance (≥50%), and interpretability principle will be applied to determine the number of factors to be retained. Squared multiple correlations are used to compute the communality
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.
Cronbach's alpha coefficient, a measure of internal consistency, will be calculated for each subscale. A value > .70 indicates sufficient reliability of the questionnaire for application at the group level, while a value > .90 implies suitability for individual assessment
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.
Test-retest reliability for each subscale will be evaluated using a two-way mixed-effects model for the intraclass correlation coefficient (ICC), type (3.1), with 95% confidence intervals reported (CI) (15). The strength of agreement will be interpreted following the guideline provided by Cicchetti (1994) (16): < 0.40 = poor, 0.40-0.59 = fair, 0.60-0.74 = good, 0.75-1.00 = excellent. For individual items, quadratic weighted Cohen's kappa will be calculated along with its 95% to identify problematic items, with interpretation based on the standards proposed by Landis and Koch (1977) (17): <0 = poor, 0.01-0.20 = slight, 0.21-0.40 = fair, 0.41-0.60 = moderate, 0.61-0.80 = substantial, and 0.81-.001 = almost perfect.
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.
The responsiveness of the questionnaire will be determined using the construct approach in which preoperative and postoperative scores are compared using a paired t-test or Wilcoxon signed-rank test for skewed data. The effect size will be expressed in Cohen's d and is calculated as the mean difference divided by the standard deviation of the difference. We hypothesize that the total score on the PEEQ and mean scores per subscale improve after surgical correction of the pectus excavatum deformity as demonstrated by the original questionnaire (2,3). Responsiveness of individual items will be evaluated using a paired t-test or Wilcoxon signed-rank test, as appropriate, to guide further item refinement.
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.

The standard error of measurement (SEM) quantifies the precision of the scores across different time points and is calculated as (18):

SEM = squareroot of MSE

Where:

· Mean square error (MSE) is the error term obtained from repeated measures ANOVA

The SDC represents the minimum change in points a patient must score on the questionnaire over time to ensure the observed change reflects a real change and not a measurement error. The SDC is expressed in points on the PEEQ and will be calculated for the mean scores per subscale, and the total scores of the child's section, parent's section and entire questionnaire. The SDC at a 95% confidence level will be calculated as (18):

SDC = 1.96 x square root of 2 x SEM

Where:

  • 1.96 is the z-score corresponding to a 95% confidence level
  • square root of 2 x SEM accounts for the error variance from both time points
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

Outcome Measure
Measure Description
Time Frame
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.
The floor and ceiling effects will be assessed by calculating the proportion of participants scoring the lowest or highest possible scores. Effects are considered substantial if > 15% of the participants score at the extremes for a specific item or subscale (18).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erik de Loos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z2021173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

trough publication in a peer-reviewed journal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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