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

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 exi...

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Autores principales: Negrini, Stefano, Donzelli, Sabrina, Negrini, Francesco, Arienti, Chiara, Zaina, Fabio, Peers, Koen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
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Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8584294/
https://www.ncbi.nlm.nih.gov/pubmed/34768544
http://dx.doi.org/10.3390/jcm10215020
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author Negrini, Stefano
Donzelli, Sabrina
Negrini, Francesco
Arienti, Chiara
Zaina, Fabio
Peers, Koen
author_facet Negrini, Stefano
Donzelli, Sabrina
Negrini, Francesco
Arienti, Chiara
Zaina, Fabio
Peers, Koen
author_sort Negrini, Stefano
collection PubMed
description 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.
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spelling pubmed-85842942021-11-12 A Pragmatic Benchmarking Study of an Evidence-Based Personalised Approach in 1938 Adolescents with High-Risk Idiopathic Scoliosis Negrini, Stefano Donzelli, Sabrina Negrini, Francesco Arienti, Chiara Zaina, Fabio Peers, Koen J Clin Med Article 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. MDPI 2021-10-28 /pmc/articles/PMC8584294/ /pubmed/34768544 http://dx.doi.org/10.3390/jcm10215020 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Negrini, Stefano
Donzelli, Sabrina
Negrini, Francesco
Arienti, Chiara
Zaina, Fabio
Peers, Koen
A Pragmatic Benchmarking Study of an Evidence-Based Personalised Approach in 1938 Adolescents with High-Risk Idiopathic Scoliosis
title A Pragmatic Benchmarking Study of an Evidence-Based Personalised Approach in 1938 Adolescents with High-Risk Idiopathic Scoliosis
title_full A Pragmatic Benchmarking Study of an Evidence-Based Personalised Approach in 1938 Adolescents with High-Risk Idiopathic Scoliosis
title_fullStr A Pragmatic Benchmarking Study of an Evidence-Based Personalised Approach in 1938 Adolescents with High-Risk Idiopathic Scoliosis
title_full_unstemmed A Pragmatic Benchmarking Study of an Evidence-Based Personalised Approach in 1938 Adolescents with High-Risk Idiopathic Scoliosis
title_short A Pragmatic Benchmarking Study of an Evidence-Based Personalised Approach in 1938 Adolescents with High-Risk Idiopathic Scoliosis
title_sort pragmatic benchmarking study of an evidence-based personalised approach in 1938 adolescents with high-risk idiopathic scoliosis
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8584294/
https://www.ncbi.nlm.nih.gov/pubmed/34768544
http://dx.doi.org/10.3390/jcm10215020
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