Validation of the Quality of Life Assessment in Spina Bifida for Children and Adolescents in Dutch
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Internal consistency of QUALAS
研究概览
简要总结
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.
详细描述
Introduction and rationale Patients with spina bifida often face challenges in different areas. It is common to have a dedicated team of medical specialists for yearly follow-up. This team includes paediatricians, neurosurgeons, orthopaedics, urologists and rehabilitation specialists. Patients with spina bifida may experience symptoms in each of these areas which will have an impact of these patient's quality of life. From the urologist perspective urinary incontinence and faecal incontinence have a high impact on quality of life.
Questionnaires to evaluate quality of life in patients with spina bifida do not incorporate these specific symptoms. The QUAlity of Life Assessment in Spina bifida in Children (QUALAS-C), QUAlity of Life Assessment in Spina bifida in Teenagers (QUALAS-T) and The QUAlity of Life Assessment in Spina bifida in Adults (QUALAS-A) have been developed to take these symptoms into account when assessing quality of life. These questionnaires are validated in the United States. For children aged 8-12 years the QUALAS-C version is available. For children between 13-17 years of age the QUALAS-T version is available. For adults the QUALAS-A version is available.
Currently, no versions of the QUALAS-C, QUALAS-T, QUALAS-A questionnaires are available in Dutch.
With the QUALAS-C, QUALAS-T and QUALAS-A the investigators will be able to assess spina bifida related quality of life and monitor the development over time. This will enable clinicians to offer improved standardized care.
Objective(s) The aim of this study is to validate the QUALAS questionnaire for children, teenagers and adults in Dutch.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient group:
- •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
- •Adult or child and at least one parent fluent in the Dutch language
- •Signed informed consent
- •Control group:
- •Male or female children aged 8 -12 years (QUALAS-C)
- •Male or female adolescents aged 13 - 17 years (QUALAS-T)
- •Adults (QUALAS-A)
- •Has no spina bifida
- •Adult or child and at least one parent fluent in the Dutch language
- •Signed informed consent
排除标准
- •Has a neurogenic disease other than spina bifida
- •Has had surgery in the last month
结局指标
主要结局
Internal consistency of QUALAS
时间窗: 3 months
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.
次要结局
- Reproducibility(2 weeks)
- Content validity(3 months)
- Construct validity(3 months)
研究者
Lisette 't Hoen
Principal Investigator
Erasmus Medical Center