The effectiveness of a protocol without routine radiographs for follow-up of adolescent idiopathic scoliosis patients (CURVE): a study protocol.
Publication year
2024Source
Acta Orthopaedica Scandinavica, 95, (2024), pp. 298-306ISSN
Publication type
Article / Letter to editor
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Organization
Orthopaedics
Rehabilitation
IQ health
Primary and Community Care
Journal title
Acta Orthopaedica Scandinavica
Volume
vol. 95
Page start
p. 298
Page end
p. 306
Subject
IQ health - Radboud University Medical Center; Orthopaedics - Radboud University Medical Center; Pharmacy - Radboud University Medical Center; Primary and Community Care - Radboud University Medical Center; Rehabilitation - Radboud University Medical CenterAbstract
BACKGROUND AND PURPOSE: Current follow-up protocols for adolescent idiopathic scoliosis (AIS) are based on consensus and consist of regular full-spine radiographs to monitor curve progression and surgical complications. Consensus exists to avoid inappropriate use of radiographs in children. It is unknown whether a standard radiologic follow-up (S-FU) approach is necessary or if a patient-empowered follow-up (PE-FU) approach can reduce the number of radiographs without treatment consequences. METHODS AND ANALYSES: A nationwide multicenter pragmatic randomized preference trial was designed for 3 follow-up subgroups (pre-treatment, post-brace, post-surgery) to compare PE-FU and S-FU. 812 patients with AIS (age 10-18 years) will be included in the randomized trial or preference cohorts. Primary outcome is the proportion of radiographs with a treatment consequence for each subgroup. Secondary outcomes consist of the proportion of patients with delayed initiation of treatment due to non-routine radiographic follow-up, radiation exposure, societal costs, positive predictive value, and interrelation of clinical assessment, quality of life, and parameters for initiation of treatment during follow-up. Outcomes will be analyzed using linear mixed-effects models, adjusted for relevant baseline covariates, and are based on intention-to-treat principle. Study summary: (i) a national, multicenter pragmatic randomized trial addressing the optimal frequency of radiographic follow-up in patients with AIS; (ii) first study that includes patient-empowered follow-up; (iii) an inclusive study with 3 follow-up subgroups and few exclusion criteria representative for clinical reality; (iv) preference cohorts alongside to amplify generalizability; (v) first study conducting an economic evaluation comparing both follow-up approaches.
This item appears in the following Collection(s)
- Academic publications [245186]
- Electronic publications [132505]
- Faculty of Medical Sciences [93207]
- Open Access publications [106110]
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