The effectiveness of a protocol without routine radiographs for follow-up of adolescent idiopathic scoliosis patients (CURVE): a study protocol
DOI:
https://doi.org/10.2340/17453674.2024.40904Keywords:
adolescent idiopatic scoliosis, follow-up, Paediatric orthopaedics, patient empoweredAbstract
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.
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Weinstein S L, Dolan L A, Cheng J C, Danielsson A, Morcuende J A. Adolescent idiopathic scoliosis. Lancet 2008; 371(9623): 1527-37. doi: 10.1016/s0140-6736(08)60658-3. DOI: https://doi.org/10.1016/S0140-6736(08)60658-3
Negrini S, Grivas T B, Kotwicki T, Maruyama T, Rigo M, Weiss H R. Why do we treat adolescent idiopathic scoliosis? What we want to obtain and to avoid for our patients. SOSORT 2005 Consensus paper. Scoliosis 2006; 1:4. doi: 10.1186/1748-7161-1-4. DOI: https://doi.org/10.1186/1748-7161-1-4
de Kleuver M, Lewis S J, Germscheid N M, Kamper S J, Alanay A, Berven S H, et al. Optimal surgical care for adolescent idiopathic scoliosis: an international consensus. Eur Spine J 2014; 23(12): 2603-18. doi: 10.1007/s00586-014-3356-1. DOI: https://doi.org/10.1007/s00586-014-3356-1
Negrini S, Aulisa A G, Aulisa L, Circo A B, de Mauroy J C, Durmala J, et al. 2011 SOSORT guidelines: Orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Dis 2012; 7. doi: 10.1186/1748-7161-7-3. DOI: https://doi.org/10.1186/1748-7161-7-3
Negrini S, Donzelli S, Aulisa A G, Czaprowski D, Schreiber S, de Mauroy J C, et al. 2016 SOSORT guidelines: Orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Dis 2018; 13. doi: 10.1186/s13013-017-0145-8. DOI: https://doi.org/10.1186/s13013-017-0145-8
Simony A, Hansen E J, Christensen S B, Carreon L Y, Andersen M O. Incidence of cancer in adolescent idiopathic scoliosis patients treated 25 years previously. Eur Spine J 2016; 25(10): 3366-70. doi: 10.1007/s00586-016-4747-2. DOI: https://doi.org/10.1007/s00586-016-4747-2
Ronckers C M, Land C E, Miller J S, Stovall M, Lonstein J E, Doody M M. Cancer mortality among women frequently exposed to radiographic examinations for spinal disorders. Radiat Res 2010; 174(1): 83-90. doi: 10.1667/rr2022.1. DOI: https://doi.org/10.1667/RR2022.1
Almén A J, Mattsson S. Dose distribution at radiographic examination of the spine in pediatric radiology. Spine (Phila Pa 1976). 1996; 21(6): 750-6. doi: 10.1097/00007632-199603150-00019. DOI: https://doi.org/10.1097/00007632-199603150-00019
Rose L D, Williams R, Ajayi B, Abdalla M, Bernard J, Bishop T, et al. Reducing radiation exposure and cancer risk for children with scoliosis: EOS the new gold standard. Spine Deform 2023; 11(4): 847-51. doi: 10.1007/s43390-023-00653-6. DOI: https://doi.org/10.1007/s43390-023-00653-6
Cuschieri S. The CONSORT statement. Saudi J Anaesth 2019; 13(Suppl 1): S27-s30. doi: 10.4103/sja.SJA_559_18. DOI: https://doi.org/10.4103/sja.SJA_559_18
Bunnell W P. Outcome of spinal screening. Spine 1993; 18(12): 1572-80. doi: 10.1097/00007632-199309000-00001. DOI: https://doi.org/10.1097/00007632-199309000-00001
Schepers S A, Sint Nicolaas S M, Haverman L, Wensing M, Schouten van Meeteren A Y N, Veening M A, et al. Real-world implementation of electronic patient-reported outcomes in outpatient pediatric cancer care. Psycho-Oncology 2017; 26(7): 951-9. doi: 10.1002/pon.4242. DOI: https://doi.org/10.1002/pon.4242
Weinstein S L, Dolan L A, Wright J G, Dobbs M B. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med 2013; 369(16): 1512-21. doi: 10.1056/NEJMoa1307337.
Lonstein J E, Carlson J M. The prediction of curve progression in untreated idiopathic scoliosis during growth. J Bone Joint Surg Am 1984; 66a(7): 1061-71. doi: 10.2106/00004623-198466070-00013. DOI: https://doi.org/10.2106/00004623-198466070-00013
Yang M Y, Zhao Y C, Yin X, Chen Z Q, Yang C W, Li L, et al. Prevalence, risk factors, and characteristics of the “adding-on” phenomenon in idiopathic scoliosis after correction surgery: a systematic review and meta-analysis. Spine 2018; 43(11): 780-90. doi: 10.1097/Brs.0000000000002423. DOI: https://doi.org/10.1097/BRS.0000000000002423
White I R, Royston P, Wood A M. Multiple imputation using chained equations: issues and guidance for practice. Stati Med 2011; 30(4): 377-99. doi: 10.1002/sim.4067. DOI: https://doi.org/10.1002/sim.4067
El Alili M, van Dongen J M, Goldfeld K S, Heymans M W, van Tulder M W, Bosmans J E. Taking the analysis of trial-based economic evaluations to the next level: the importance of accounting for clustering. Pharmacoeconomics 2020; 38(11): 1247-61. doi: 10.1007/s40273-020-00946-y. DOI: https://doi.org/10.1007/s40273-020-00946-y
Ben  J, van Dongen J M, El Alili M, Esser J L, Broulíková H M, Bosmans J E. Conducting trial-based economic evaluations using R: a tutorial. Pharmacoeconomics 2023; 41(11): 1403-13. doi: 10.1007/s40273-023-01301-7. DOI: https://doi.org/10.1007/s40273-023-01301-7
Association WM. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 2013; 310(20): 2191-4. doi: 10.1001/jama.2013.281053. DOI: https://doi.org/10.1001/jama.2013.281053
Weinstein S L, Dolan L A, Wright J G, Dobbs M B. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med 2013; 369(16): 1512-21. doi: 10.1056/NEJMoa1307337. DOI: https://doi.org/10.1056/NEJMoa1307337
ZonMw Z G. gehonoreerde subsidieaanvraag “The (cost-)effectiveness of a new patient empowered protocol without routine X-rays for follow-up of adolescent idiopathic scoliosis patients: a pragmatic randomized trial”. Projectnummer 10330022010004. Available from: https://www.zonmw.nl/nl/onderzoek-resultaten/doelmatigheidsonderzoek/programmas/project-detail/evaluatieonderzoek-zegg/the-cost-effectiveness-of-a-new-patient-empowered-protocol-without-routine-x-rays-for-follow-up-of/.
Dimeglio A, Canavese F, Charles P. Growth and adolescent idiopathic scoliosis: when and how much? J Pediatr Orthoped 2011; 31: S28-S36. DOI: https://doi.org/10.1097/BPO.0b013e318202c25d
SRS. Sanders Webinar SRS Research Grant Outcome Symposium March 6 2021. Available from: https://www.srs.org/Research/SRS-Research-Grants/SRS-Research-Grant-Outcome-Symposium.
CBS. How many residents have a foreign country of origin? 2023. Available from: https://www.cbs.nl/en-gb/dossier/asylum-migration-and-integration/how-many-residents-have-a-foreign-country-of-origin-.
Versteegh M M, Vermeulen K M, Evers S M A A, de Wit G A, Prenger R, Stolk E A. Dutch tariff for the five-level version of EQ-5D. Value Health 2016; 19(4): 343-52. doi: 10.1016/j.jval.2016.01.003. DOI: https://doi.org/10.1016/j.jval.2016.01.003
Schlosser T P C, Stadhouder A, Schimmel J J P, Lehr A M, van der Heijden G J M G, Castelein R E M. Reliability and validity of the adapted Dutch version of the revised Scoliosis Research Society 22-item questionnaire. Spine J 2014; 14(8): 1663-72. doi: 10.1016/j.spinee.2013.09.046. DOI: https://doi.org/10.1016/j.spinee.2013.09.046
Carreon L Y, Sanders J O, Polly D W, Sucato D J, Parent S, Roy-Beaudry M, et al. Spinal Appearance Questionnaire factor analysis, scoring, reliability, and validity testing. Spine 2011; 36(18): E1240-E4. doi: 10.1097/BRS.0b013e318204f987. DOI: https://doi.org/10.1097/BRS.0b013e318204f987
van de Fliert D G, Schlösser T P C, Kempen D H R, Rutges J P H J, Bisseling P, de Kleuver M, et al. The Dutch version of the Spinal Appearance Questionnaire for adolescents with idiopathic scoliosis: patient-based cross-cultural adaptation and measurement properties evaluation. Spine Deformity 2023. doi: 10.1007/s43390-023-00746-2. DOI: https://doi.org/10.1007/s43390-023-00746-2
Kamper S J, Ostelo R W J G, Knol D L, Maher C G, de Vet H C W, Hancock M J. Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. J Clin Epidemiol 2010; 63(7): 760-6. doi: 10.1016/j.jclinepi.2009.09.009. DOI: https://doi.org/10.1016/j.jclinepi.2009.09.009
Kanters T A, Bouwmans C A M, van der Linden N, Tan S S, Hakkaart-van Roijen L. Update of the Dutch manual for costing studies in health care. Plos One 2017; 12(11). doi: ARTNe0187477.10.1371/journal.pone.0187477. DOI: https://doi.org/10.1371/journal.pone.0187477
Mens R H, van Hooff M L, Geuze R E, Spruit M, Horsting P P, de Kleuver M, et al. No added value of 2-year radiographic follow-up of fusion surgery for adolescent idiopathic scoliosis. Eur Spine J 2021; 30(3): 759-67. doi: 10.1007/s00586-020-06696-x. DOI: https://doi.org/10.1007/s00586-020-06696-x
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Copyright (c) 2024 Jurre T F Baetsen, Miranda L Hooff, Pepijn Bisseling, Johanna M van Dongen, Dineke G van de Fliert, Eric Hoebink, Diederik H R Kempen, Joost P H J Rutges, Tom P C Schlösser, Hanneke M van West, Philip J Van der Wees, Paul C Willems, Marinus de Kleuver
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