Health-related Quality of Life in Chiari Malformation Type 1 - A National Cross-Sectional Patient Survey
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,004
- 试验地点
- 1
- 主要终点
- EQ-5D index score
研究概览
简要总结
The goal of this observational survey study is to investigate factors that may affect the health-related quality of life (HRQoL) in adults with Chiari malformation type 1 (CM1). The main questions it aims to answer are:
How do CM1 patients rate their HRQoL compared to the general population? Are there any factors that lead to better or worse HRQoL in CM1 patients? Is there a difference in HRQoL in operated versus non-operated CM1 patients?
Participants will be identified via the Swedish National Board of Health and Welfare's Patient register. They will be asked to participate in a survey of HRQoL containing standardized questionnaires, and their answers will be analyzed together with data from the Patient register. Their questionnaire answers will also be compared to normative Swedish data.
详细描述
This is an observational, cross-sectional survey study investigating health-related quality of life (HRQoL) in adults with Chiari malformation type 1 (CM1).
A total of 1,004 adults with CM1 will be invited to participate, including 666 patients who have undergone surgery for CM1 and 338 patients who have not. Participants were identified through the Swedish National Board of Health and Welfare's National Patient Register, which holds data on all inpatient episodes as well as specialized outpatient visits in Sweden.
Operated patients were identified based on diagnosis of Arnold Chiari Malformation (ICD-code Q07.0) and posterior fossa decompression (procedure code ABE50) recorded in the National Patient Register between 2011 and 2024. Non-operated patients were identified based on a diagnosis of CM1 (ICD-10 code Q07.0) recorded during a visit to a neurosurgical outpatient clinic between 2021 and 2024. Patients with a diagnosis of spina bifida (ICD-10 code Q05.X) were excluded from the overall cohort. Non-operated patients with a record of duraplasty (procedure code AAK10) or another operation on the cranium or dura (procedure code AAK99) were excluded.
Participants will be contacted by mail and invited to complete an online survey administered through REDCap, hosted by Karolinska Institutet. The survey includes the Swedish version of the EQ-5D-3L, including the EQ Visual Analogue Scale (EQ-VAS), the Hospital Anxiety and Depression Scale (HADS), and a study-specific questionnaire focusing on clinical characteristics, medication use, sick leave, return to work, and attitudes toward surgical treatment.
Survey data will be linked to relevant information from the National Patient Register and the Swedish Social Insurance Agency. Register data will include information on diagnoses, surgical treatment, comorbidities, and relevant social insurance variables.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Arnold Chiari Malformation (ICD-code Q07.0)
- •for operated patients: record of posterior fossa decompression (procedure code ABE50)
- •for non-operated patients: the diagnosis Q07.0 recorded during an outpatient visit to a neurosurgical unit
排除标准
- •record of spina bifida diagnosis (Q05.X)
- •for non-operated patients: record of the procedures duraplasty (procedure code AAK10) or another operation on the cranium or dura (procedure code AAK99)
研究组 & 干预措施
Chiari Malformation Type 1, operated
Patients identified via the National Patient Register to have 1) diagnosis of Arnold Chiari Malformation (ICD-code Q07.0), 2) received posterior fossa decompression (procedure code ABE50), 3) no record of spina bifida diagnosis (Q05.X), which would indicate Chiari Malformation type 2. The group was limited to the years 2011-2024 to ensure approximately 2/3 of 1000 patients, resulting in 666 eligible participants. Only patients ≥18 years of age at the time the diagnosis was first recorded were included.
Chiari Malformation Type 1, non-operated
Patients identified via the National Patient Register to have 1) diagnosis of Arnold Chiari Malformation (ICD-code Q07.0), 2) the diagnosis recorded at a visit to a neurosurgical unit, 3) no record of posterior fossa decompression (procedure code ABE50) or the similar procedures duraplasty (procedure code AAK10) or another operation on the cranium or dura (procedure code AAK99), 4) no record of spina bifida diagnosis (Q05.X), which would indicate Chiari Malformation type 2. The group was limited to the years 2021-2024 to ensure approximately 1/3 of 1000 patients, resulting in 338 eligible participants. Only patients ≥18 years of age at the time the diagnosis was first recorded were included.
结局指标
主要结局
EQ-5D index score
时间窗: Baseline
Combined value of the five dimensions of the Euroqol five-dimensional three level (EQ-5D-3L) questionnaire, based on the United Kingdom value set. The index score has a value between 0 and 1, where 1 represents full health.
EQ-5D VAS score
时间窗: Baseline
The Euroqol five-dimensonial (EQ-5D) visual analog scale (VAS). The respondents rate their current health between 0 (worst imaginable health) and 100 (best imaginable health).
次要结局
未报告次要终点
研究者
Adrian Elmi Terander
Associate Professor
Karolinska Institutet