"The (Cost-)Effectiveness of a Patient Empowered Protocol Without Routine X-rays for Follow-up of Adolescent Idiopathic Scoliosis Patients; A Pragmatic Randomized Trial"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 812
- 试验地点
- 46
- 主要终点
- The proportion of radiographs that has led to treatment consequences
研究概览
简要总结
Objective: To evaluate the (cost-)effectiveness of a new patient-empowered follow up (FU) protocol in patients with Adolescent idiopathic Scoliosis (AIS) that is based on patient-reported outcome measures (PROMs), self-assessment tools and physical examination, which is compared to standard FU care by: 1) Effect evaluation, 2) Economic evaluation, 3) Implementation (process) evaluation.
Study design: A multicentre pragmatic randomized trial design with two arms, combined with a patient preference cohort for each arm (partially randomized preference trial [PRPT]).
Study population: A total of 812 AIS patients (age 10-18 years) treated by the Dutch AIS Consortium, representing the scoliosis treatment centres in the Netherlands, will be included.
Three subgroups of AIS patients are distinguished, which are monitored over two years:
- Pre-treatment group: adolescents with curve 10-25° (n=132 per arm; total n=264)
- Post-brace treatment group (n=122 per arm; total n=244)
- Post-surgery group (n=152 per arm; total n=304)
Intervention: The new patient-empowered FU protocol (PE-FU) is based on PROMs, self-assessment tools and clinical assessment including physical examination. The protocol aims to detect curve progression or postoperative complications based on these patient-based and clinical parameters to substitute the need to obtain routine x-rays. X-rays will only be taken when progression or postoperative complications are suspected in the pre- and post-intervention groups based on predefined criteria. The standard FU protocol consists of routine full-spine radiographs and routine clinical evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with adolescent idiopathic scoliosis (AIS).
- •Age: 10-18 years old.
- •Patients scheduled for follow up in one of the participating centres.
- •Understanding of the Dutch language.
- •Signed informed consent.
- •Biplanar (Posterior-Anterior [PA] and Lateral) full-spine x-rays within the last 3 months.
- •Specifically for the pre-treatment group:
- •Girls aged ≤14 years (i.e. 10-14 years) and boys <16 years (i.e. 10-15 years). These patients still have generally 2 years of remaining skeletal growth. Patients above this age with a curve below 25 degrees have a limited risk for progression
- •Girls: pre-menarche up to 6 months post-menarche (to estimate end of growth)
- •A primary coronal curve of 10-25 degree.
- •Specifically for the post-brace group:
- •Patients aged 12-18 years
- •Within 3 months after termination of brace treatment
- •Minimum of 6 months of brace treatment
- •Specifically for the post-surgery group:
- •Patients aged 12-18 years
排除标准
- •Patients with juvenile or infantile idiopathic scoliosis with the diagnosis of onset under the age of
- •Patients who are undergoing brace treatment. These patients are not included because of the need to monitor brace therapy with radiographs.
- •Patients who have undergone previous spinal surgery and are undergoing revision surgery.
- •Skeletally mature patients.
结局指标
主要结局
The proportion of radiographs that has led to treatment consequences
时间窗: 24 months
the proportion will serve as an indication of the sensitivity of the new PE-FU protocol and standard FU protocol. The number of x-rays that has led to treatment will be divided by the total number of x-rays in each subgroup to calculate the primary outcome.
次要结局
- The specificity, negative predictive value and positive predictive value of the standard and new patient empowered follow up protocol.(24 months)
- Self-assessment tool: Scolioscoop(or pre-treatment and the post-brace group at 6, 12,18 and 24 months and for the postsurgery group at 3,12 and 24 months)
- The change in readiation exposure(24 months)
- The safety of the standard and the new protocol(for pre-treatment and the post-brace group at 6, 12,18 and 24 months and for the postsurgery group at 3,12 and 24 months)
- Participants perspective: Numeric pain rating scale [NPRS 0-10](24 Months)
- Participants perspective: health-related quality of life [EQ5D-5L](24 months)
- Cost-Benefit analysis: Cost analysis(24 months)
- Participants perspective: Scoliosis Appearance questionnaire short version [short SAQ])(24 months)
- educational status(24 months)
- Cost-Benefit analysis: Patient outcome analysis using Quality-Adjusted Life Years (QALY).(24 months)
- Global perceirved effect [GPE](24 months)
- Participants perspective: condition-specific quality of life [SRS-22r](24 months)