跳至主要内容
临床试验/NCT04638894
NCT04638894进行中(未招募)不适用

Are Patient Characteristics and Treatment Characteristics Related to the Value of the Adult Spinal Deformity (ASD) Care Pathway in University Hospitals Leuven?

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
140
试验地点
1
主要终点
Disease specific value: Scoliosis Research Society Outcomes Questionnaire (SRS-22)

研究概览

简要总结

The study will examine if variability in created value (outcome/costs) over the care cycle for ASD patients can be explained by patient and treatment characteristics.

详细描述

Due to budget restrictions in health care, cost is a major challenge, particularly in chronic disorders affecting the ageing population for which advanced but often expensive medical technologies offer benefit. Stakeholders strive to define, assess and improve the so-called "value in healthcare" to achieve the best outcome at the lowest cost of care.

First and foremost, the investigator will try to examine if we can explain variability in the created value over the care cycle by patient and treatment characteristics. This knowledge can be used to optimize the value for the patients. Also, the investigator will try to compare the psychometric properties between the different versions of value equations, resulting from the use of different outcome tools to measure value.

Adult Spinal Deformity patients can take part in the study. This will be decided by clinical examination and radiographic evaluation and is based on at least one of the following criteria: 1) Coronal spinal curvature ≥20°, 2)Sagittal vertical axis (SVA) >5 cm, 3) Pelvic tilt >25°, 4) Thoracic kyphosis >60°. The patients have to be older than or equal to 18 years old at the time of surgery.

In line with the standard of care, the patients will be seen after 3 months, 6 months, 1 year and 2 years postoperatively. Pre- and post-operatively, questionnaires will be completed by the patients. The patient questionnaires EuroQol 5D (EQ-5D-3L and EQ-5D-5L) , Scoliosis Research Society 22 score (SRS-22), Oswestry disability Index, Core Outcome Measures Index score (COMI) and Work status will be completed by the patients during the baseline visit and on each follow-up moment at 3 months, 6 months, 1 year and 2 years.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult Spinal Deformity patients
  • Index Surgery from 15/03/2020 and 15/03/2022
  • Age of 18 years old or older at the moment of the index surgery
  • Patients treated in University Hospitals Leuven
  • Patient has full understanding and is willing to participate (Informed consent)

排除标准

  • • Patients younger than 18 years old at the moment of index surgery
  • Patients with an index surgery before 15/03/2020
  • Patients treated in other centers outside of University Hospitals Leuven

结局指标

主要结局

Disease specific value: Scoliosis Research Society Outcomes Questionnaire (SRS-22)

时间窗: 2 years

Disease-specific value, measured via the Scoliosis Research Society Outcomes Questionnaire (SRS-22), divided by costs

Disease specific value: Oswestry Low Back Pain Disability Questionnaire (ODI)

时间窗: 2 years

Disease-specific value, measured via the Oswestry Low Back Pain Disability Questionnaire (ODI), divided by costs

Generic Value

时间窗: 2 years

Generic outcome, measured via the EuroQol 5D (EQ-5D), divided by costs

Disease specific value: Core Outcome Measures Index (COMI)

时间窗: 2 years

Disease-specific value, measured via the Core Outcome Measures Index (COMI), divided by costs

次要结局

  • Return to work(2 years)
  • Workstatus(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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