QUALAS Validation in Dutch
ConditionSpina Bifida
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8+
SponsorErasmus Medical Center
About this trial
Rationale Patients with spina bifida often experience a decreased quality of life compared to patients without spina bifida. The Quality of Life Assessment for Spina Bifida (QUALAS) is a validated questionnaire to assess the quality of life in children, teenagers and adults with spina bifida, accounting for specific factors, such as bladder and bowel dysfunction. This questionnaire enables us to assess the current spina bifida related quality of life and identify if bladder and bowel dysfunction is of influence.
Objective(s) To validate the Quality of Life Assessment for Spina Bifida in Children, Teenagers and Adults in Dutch.
Study type A multicenter prospective validation cohort study.
Study population Children aged 8 - 17 years and adults who are diagnosed with spina bifida. As a control group children aged 8 - 17 years and adults without spina bifida will be approached at the Ear-Nose-Throat (ENT) and paediatric clinics.
Methods The main study parameter is the validation of the Dutch version of the questionnaire. Patients with spina bifida are asked to fill out the QUALAS at two time-points. They are also asked to fill out an extra questionnaire at two time-points, in order to validate the QUALAS. Children and adults in the control groups are asked to fill out the two questionnaires only once.
Burden and risks No (extra) outpatient visit is required. The questions in the questionnaires are similar to the medical history during an outpatient visit. The burden is therefore minimal for these patients. Participation in this study will not influence patient treatment.
Recruitment and consent Parents of children and children and adults who meet the inclusion criteria and none of the exclusion criteria will be informed orally about this study by their treating urologist during a regular visit. A patient information and consent form will be handed over to the parents and children over eight years of age and adults. Parents of children and children and adults at the ENT clinic will be approached by the local urologist for participation for this study. If they are willing to participate they will be asked to sign informed consent and fill out the questionnaire.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female patients aged 8 -12 years (QUALAS-C)
Male or female patients aged 13 - 17 years (QUALAS-T)
Adult patients (QUALAS-A)
Has spina bifida
Disqualifiers
Has a neurogenic disease other than spina bifida
Has had surgery in the last month
Trial population
Parents of children and children and adults with spina bifida that are patients at the Urology department of the two hospitals will be approached to participate. This questionnaire quantifies the quality of life in patients with spina bifida, with a special interest in bladder and bowel dysfunction. A group of children and adults without spina bifida will function as a control group. These children and adults will be approached at the ENT and paediatric clinics.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
QUALAS survey
Other interventionParticipants will be asked to complete the surveys at one (controls) and two (patients) timepoints.
Treatment groups
300 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Children with spina bifida1 intervention
Group B: Control group children1 intervention
Group C: Teenagers with spina bifida1 intervention
Group D: Control group teenagers1 intervention
Group E: Adults with spina bifida1 intervention
Group F: Control group adults1 intervention
Trial outcomes
Primary outcomes
1
Internal consistency of QUALAS
Internal consistency is the main study endpoint. This will be calculated with Cronbach's alpha. Values between 0.70 and 0.95 reflect good consistency. QUALAS questionnaire: Scores range from 0-100 with higher scores indicating better quality of life.
Time frame
3 monthsSecondary outcomes
1
Reproducibility
Reproducibility will be determined to assess the ability to reproduce similar answers during the retest period. This will be calculated using Intraclass Correlation Coefficient (ICC), where ICC scores over 0.7 are acceptable. The limits of agreement (LOA), which is calculated by mean change in scores ± 1.96 SD are determined as well.
Time frame
2 weeks2
Content validity
Content validity is subjectively determined by examining whether the questionnaire is measuring the quality of life related to spina bifida.
Time frame
3 months3
Construct validity
Construct validity is determined by testing the following hypotheses: * The control group will have higher scores in the QUALAS than patients with spina bifida. * Patients who score higher in the KIDSCREEN-27 or WHOQOL-BREF/ICIQ will have higher scores in the QUALAS. The KIDSCREEN-27: Each item is scored on a 5-point Likert scale ranging from 1 meaning "not at all" to 5 meaning "very much". Certain items (1, 9, 10 and 11) were reversed when scoring the questionnaire. Reverse scoring means that the numerical scoring scale runs in the opposite direction. The total KIDSCREEN score was calculated by summing up all the responses. Higher scores of KIDSCREEN indicated better QoL and social support. The WHOQOL-BREF questionnaire: 26 items are scored on a 5-point Likert scale. Scores range from 0-100 with higher scores indicating better quality of life The ICIQ questionnaire: 3 items are scored with a total sum range of 0-21, higher score indicate worse quality of life.
Time frame
3 monthsSponsors and contacts
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Erasmus Medical Center
Lead sponsor
University Medical Center Groningen
Collaborator
Source ClinicalTrials.gov