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

Abstract

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.

Evolution of Early Onset Scoliosis under Treatment with a 3D-Brace Concept

“…At each visit, patients had their brace checked and underwent a physical examination. Because we have a private practice and, in accordance with an evidence-based personalized approach model [ 23 ], we do not have a fixed protocol for radiographic control, an Out Of Brace (OOB) radiograph was ordered when (and only when) either a physical examination gave us a clear suspicion of curve deterioration, or we had to change the brace due to growth and development, or we suspected a change in the curve pattern necessitating a new brace design.…”

Impact of the Free-Pelvis Innovation in Very Rigid Braces for Adolescents with Idiopathic Scoliosis: Short-Term Results of a Matched Case-Control Study

“…The attention to the sagittal plane is one of the major features of the Sforzesco brace. The very high rigidity achieves the same corrective results as the Risser cast [ 13 ] and superior results compare with the Lyon brace [ 14 ]; end-of-growth results have also been documented according to classical indications [ 6 ] and in extreme, surgical cases refusing spinal fusion [ 8 ].…”

“…More details on the clinical approach are reported elsewhere [ 6 ]. In this study, all patients had to wear the brace 23 h per day.…”

“…The out-of-brace radiograph was performed immediately after brace removal at the first consultation six months after prescription (T2). We previously verified the reliability of the radiographic measurements by clinicians in our institute [ 6 , 18 ]. The secondary outcomes included clinical assessment of the angle of trunk rotation (ATR), measured using a Bunnell scoliometer [ 19 ] and aesthetics using the Trunk Aesthetic Clinical Evaluation (TRACE) score [ 20 ].…”

“…The classification introduces rigidity as a critical characteristic to distinguish braces, with three categories: elastic, rigid, and very rigid [ 5 ]. It has been proposed that the changes in the rigidity of braces can explain the efficacy in different populations, with biomechanically stronger orthoses allowing the treatment of worse AIS [ 6 ].…”