comparing use of radiographs versus patient empowerment (curve)

Conditions: Adolescent Idiopathic Scoliosis

Summary: 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: 1. pre-treatment group: adolescents with curve 10-25° (n=132 per arm; total n=264) 2. post-brace treatment group (n=122 per arm; total n=244) 3. 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.


Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * patients with juvenile or infantile idiopathic scoliosis with the diagnosis of onset under the age of 10. * 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.

Keywords: scoliosis spine quality of health care cost-benefit analysis patient participation radiology