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Article

A Pragmatic Benchmarking Study of an Evidence-Based Personalised Approach in 1938 Adolescents with High-Risk Idiopathic Scoliosis

1
Department of Biomedical, Surgical and Dental Sciences, University “La Statale”, 20122 Milan, Italy
2
IRCCS Istituto Ortopedico Galeazzi, 20161 Milan, Italy
3
ISICO (Italian Scientific Spine Institute), 20141 Milan, Italy
4
IRCCS Fondazione Don Gnocchi, 20148 Milan, Italy
5
Department of Physical Medicine and Rehabilitation, University Hospital Leuven, 3000 Leuven, Belgium
6
Department of Development and Regeneration, University of Leuven, 3000 Leuven, Belgium
*
Author to whom correspondence should be addressed.
Academic Editor: Theodoros B. Grivas
J. Clin. Med. 2021, 10(21), 5020; https://doi.org/10.3390/jcm10215020
Received: 21 September 2021 / Revised: 21 October 2021 / Accepted: 23 October 2021 / Published: 28 October 2021
Combining evidence-based medicine and shared decision making, current guidelines support an evidence-based personalised approach (EBPA) for idiopathic scoliosis in adolescents (AIS). EBPA is considered important for adolescents’ compliance, which is particularly difficult in AIS. Benchmarking to existing Randomised Controlled Trials (RCTs) as paradigms of single treatments, we aimed to check the effectiveness and burden of care of an EBPA in high-risk AIS. This study’s design features a retrospective observation of a prospective database including 25,361 spinal deformity patients < 18 years of age. Participants consisted of 1938 AIS, 11–45° Cobb, Risser stage 0–2, who were studied until the end of growth. EBPA included therapies classified for burdensomeness according to current guidelines. Using the same inclusion criteria of the RCTs on exercises, plastic, and elastic bracing, out of the 1938 included, we benchmarked 590, 687, and 884 participants, respectively. We checked clinically significant results and burden of care, calculating Relative Risk of success (RR) and Number Needed to Treat (NNT) for efficacy (EA) and intent-to-treat analyses. At the end of growth, 19% of EBPA participants progressed, while 33% improved. EBPA showed 2.0 (1.7–2.5) and 2.9 (1.7–4.9) RR of success versus Weinstein and Coillard’s studies control groups, respectively. Benchmarked to plastic or elastic bracing, EBPA had 1.4 (1.2–1.5) and 1.7 (1.2–2.5) RR of success, respectively. The EBPA treatment burden was greater than RCTs in 48% of patients, and reduced for 24% and 42% versus plastic and elastic bracing, respectively. EBPA showed to be from 40% to 70% more effective than benchmarked individual treatments, with low NNT. The burden of treatment was frequently reduced, but it had to be increased even more frequently. View Full-Text
Keywords: adolescent idiopathic scoliosis; shared decision-making; personalised approach; bracing adolescent idiopathic scoliosis; shared decision-making; personalised approach; bracing
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MDPI and ACS Style

Negrini, S.; Donzelli, S.; Negrini, F.; Arienti, C.; Zaina, F.; Peers, K. A Pragmatic Benchmarking Study of an Evidence-Based Personalised Approach in 1938 Adolescents with High-Risk Idiopathic Scoliosis. J. Clin. Med. 2021, 10, 5020. https://doi.org/10.3390/jcm10215020

AMA Style

Negrini S, Donzelli S, Negrini F, Arienti C, Zaina F, Peers K. A Pragmatic Benchmarking Study of an Evidence-Based Personalised Approach in 1938 Adolescents with High-Risk Idiopathic Scoliosis. Journal of Clinical Medicine. 2021; 10(21):5020. https://doi.org/10.3390/jcm10215020

Chicago/Turabian Style

Negrini, Stefano, Sabrina Donzelli, Francesco Negrini, Chiara Arienti, Fabio Zaina, and Koen Peers. 2021. "A Pragmatic Benchmarking Study of an Evidence-Based Personalised Approach in 1938 Adolescents with High-Risk Idiopathic Scoliosis" Journal of Clinical Medicine 10, no. 21: 5020. https://doi.org/10.3390/jcm10215020

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