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      Recommendations for research studies on treatment of idiopathic scoliosis: Consensus 2014 between SOSORT and SRS non–operative management committee

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      , , , , SOSORT Boards, SRS Non-Operative Committee
      Scoliosis
      BioMed Central

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          Abstract

          The two main societies clinically dealing with idiopathic scoliosis are the Scoliosis Research Society (SRS), founded in 1966, and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT), started in 2004. Inside the SRS, the Non-Operative Management Committee (SRS-NOC) has the same clinical interest of SOSORT, that is the Orthopaedic and Rehabilitation (or Non-Operative, or conservative) Management of idiopathic scoliosis patients. The aim of this paper is to present the results of a Consensus among the best experts of non-operative treatment of Idiopathic Scoliosis, as represented by SOSORT and SRS, on the recommendation for research studies on treatment of Idiopathic Scoliosis. The goal of the consensus statement is to establish a framework for research with clearly delineated inclusion criteria, methodologies, and outcome measures so that future meta- analysis or comparative studies could occur. A Delphi method was used to generate a consensus to develop a set of recommendations for clinical studies on treatment of Idiopathic Scoliosis. It included the development of a reference scheme, which was judged during two Delphi Rounds; after this first phase, it was decided to develop the recommendations and 4 other Delphi Rounds followed. The process finished with a Consensus Meeting, that was held during the SOSORT Meeting in Wiesbaden, 8–10 May 2014, moderated by the Presidents of SOSORT (JP O’Brien) and SRS (SD Glassman) and by the Chairs of the involved Committees (SOSORT Consensus Committee: S Negrini; SRS Non-Operative Committee: MT Hresko). The Boards of the SRS and SOSORT formally accepted the final recommendations. The 18 Recommendations focused: Research needs (3), Clinically significant outcomes (4), Radiographic outcomes (3), Other key outcomes (Quality of Life, adherence to treatment) (2), Standardization of methods of non-operative research (6).

          Electronic supplementary material

          The online version of this article (doi:10.1186/s13013-014-0025-4) contains supplementary material, which is available to authorized users.

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          Most cited references68

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          Adherence to long-term therapies: evidence for action.

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            Adolescent idiopathic scoliosis.

            Adolescent idiopathic scoliosis (AIS) affects 1-3% of children in the at-risk population of those aged 10-16 years. The aetiopathogensis of this disorder remains unknown, with misinformation about its natural history. Non-surgical treatments are aimed to reduce the number of operations by preventing curve progression. Although bracing and physiotherapy are common treatments in much of the world, their effectiveness has never been rigorously assessed. Technological advances have much improved the ability of surgeons to safely correct the deformity while maintaining sagittal and coronal balance. However, we do not have long-term results of these changing surgical treatments. Much has yet to be learned about the general health, quality of life, and self-image of both treated and untreated patients with AIS.
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              Effects of bracing in adolescents with idiopathic scoliosis.

              The role of bracing in patients with adolescent idiopathic scoliosis who are at risk for curve progression and eventual surgery is controversial. We conducted a multicenter study that included patients with typical indications for bracing due to their age, skeletal immaturity, and degree of scoliosis. Both a randomized cohort and a preference cohort were enrolled. Of 242 patients included in the analysis, 116 were randomly assigned to bracing or observation, and 126 chose between bracing and observation. Patients in the bracing group were instructed to wear the brace at least 18 hours per day. The primary outcomes were curve progression to 50 degrees or more (treatment failure) and skeletal maturity without this degree of curve progression (treatment success). The trial was stopped early owing to the efficacy of bracing. In an analysis that included both the randomized and preference cohorts, the rate of treatment success was 72% after bracing, as compared with 48% after observation (propensity-score-adjusted odds ratio for treatment success, 1.93; 95% confidence interval [CI], 1.08 to 3.46). In the intention-to-treat analysis, the rate of treatment success was 75% among patients randomly assigned to bracing, as compared with 42% among those randomly assigned to observation (odds ratio, 4.11; 95% CI, 1.85 to 9.16). There was a significant positive association between hours of brace wear and rate of treatment success (P<0.001). Bracing significantly decreased the progression of high-risk curves to the threshold for surgery in patients with adolescent idiopathic scoliosis. The benefit increased with longer hours of brace wear. (Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and others; BRAIST ClinicalTrials.gov number, NCT00448448.).
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                Author and article information

                Contributors
                stefano.negrini@unibs.it
                timothy.hresko@childrens.harvard.edu
                jpobrien@scoliosis.org
                nprice@cmh.edu
                Journal
                Scoliosis
                Scoliosis
                Scoliosis
                BioMed Central (London )
                1748-7161
                7 March 2015
                7 March 2015
                2015
                : 10
                : 8
                Affiliations
                [ ]Clinical and Experimental Sciences Department, University of Brescia, Viale Europa 32, 25123 Brescia, Italy
                [ ]IRCCS Fondazione Don Gnocchi, Milan, Italy
                [ ]Department of Orthoapedic Surgery, Harvard Medical School, Boston Children’s Hospital, Boston, USA
                [ ]National Scoliosis Foundation, Stoughton, MA USA
                [ ]Children’s Mercy Hospital, University of Missouri Kansas City, Kansas, USA
                Article
                25
                10.1186/s13013-014-0025-4
                4360938
                25780381
                8ccd511f-81e3-4e0f-9bdb-b88eb47ce04e
                © Negrini et al.; licensee BioMed Central. 2015

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 12 December 2014
                : 12 December 2014
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                © The Author(s) 2015

                Orthopedics
                Orthopedics

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