Translation and Validation of a Disease-specific Questionnaire for Hirschsprung's Disease in Danish Patients

NCT04730128 | Completed DMC

• 1 other identifier: 011-2018-NQ
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

The Hirschsprung and anorectal malformation quality of life (HAQL) questionnaire is a disease-specific quality of life questionnaire with 5 different elements (3 questionnaires for patients (categories: age 8-11, 12-16, and \>17 years) and two questionnaires for parents of patients (categories: patients aged 8-11 and 12-16 years). In the first part of this study, the questionnaires will be translated via forward-backward-translation, culturally adapted and evaluated for content validity. In the second part of the study, the questionnaires will be validated in a cohort of all eligible Hirschsprung patients from Odense University Hospital from 1985-2014.

Conditions

Hirschsprung Disease

Keywords

Hirschsprung Disease; Quality of Life; Translation and validation

Outcome Measures

Primary Outcomes (1)

• Internal Consistency (IC) assessed by Cronbach's Alpha

  Day 1

Secondary Outcomes (1)

• Test-retest reliability assessed by intraclass-correlations coefficient

  4 weeks

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Based on the ICD-10 code for Hirschsprung's disease, all patients with Hirschsprung's disease diagnosed in Odense University Hospital will be offered to participate in the study. The diagnosis must be registered between the years 1985-2014 and the patient must be \> 7 years at the study initiation.

You may qualify if:

• Diagnosed with Hirschsprung's Disease between the years 1985-2014
• Age \> 7 years
• Good Danish comprehension
• Signed informed consent

You may not qualify if:

• Inability to follow the procedures of the study, e.g. due to language problems, severe psychological disorders, dementia, etc.

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator

Study Sites (1)

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

MeSH Terms

Conditions

Hirschsprung Disease

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 29, 2021
• Study Start: July 1, 2020
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

DK (1)