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Isico involved in an international research project: brace versus plaster cast

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An international project involving clinical centres in 40 countries in the US, Canada, Europe and Asia has just started. Target? A comparison between the use of plaster casts and braces in the treatment of infantile scoliosis.
Isico is one of the centres involved, thus representing Italy, expressly invited given the clinical and research experience gained over the years.

The project manager is Prof. Stuart L. Weinstein, referent Dr Lori A. Dolan, both from the American University of Iowa. The target enrollment is 440 subjects (220 patients and 220 parents). For Isico, the head researcher is Prof. Negrini, while Dr Donzelli is involved as the research referent.

We recall that infantile (early-onset) idiopathic scoliosis (IEOS) is a relatively rare disease affecting 40 out of 100,000 children. Defined as an idiopathic curve measuring > 20 degrees in those less than three years of age, the natural history of IEOS is variable with some curves resolving spontaneously and others quickly progressing to such a degree that severe pulmonary disease and shortened life span may occur. Casting, and less frequently bracing, have been used to treat this condition in hopes of resolving the curve or at least delaying surgical interventions.

The plaster cast is widely used for these early forms of scoliosis, but a plaster requires hospitalization, sedation, and daily handling is much less comfortable for hygiene than a removable brace.

“During the two-year duration of the project, funded by the University of Iowa and The Orthopedic Research and Education Foundation, – explains Dr Donzelli – we will bring between 5 and 10 cases treated at our Institute to research purposes. Isico has several years of experience in the use of braces; our participation will not involve the application of plaster casts; our results will be compared with those of other centres that apply these casts “.

And the Sosort Award winner is… Isico!

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At the International Sosort Meeting in June, this year held for the first time ever entirely online, Isico recorded another great success.

Dr Sabrina Donzelli, Isico physiatrist, won the Sosort Award, the event’s top prize, for her research entitled: “Predicting final results of Brace Treatment of Adolescents with Idiopathic Scoliosis: First Out-of-Brace are Better than In-Brace-radiographs”. Her study was chosen over the work of 7 other researchers in the running for the award.

Among eight studies selected as oral presentations, the Scientific Committee picked out, as the two finalists, Dr Donzelli’s research study and a study on the genetics of scoliosis by the Montreal-based research group led by Prof A Moreau. “After the initial selection we were asked to submit a complete article to be entered for the Sosort Award” explains Dr Donzelli. “The prize, for the winning study, is a sum of money allowing it to be published in any magazine, as an open-access article, in other words in a format accessible, free of charge, to anyone who might be interested in reading it”.

The other studies running for the award included a long-term follow up of patients with scoliosis, presented by Dr AG Aulisa, a cost analysis of conservative versus surgical treatment, and two studies on Scolioscan©, the ultrasound equipment present as well at Isico’s Milan clinic. 

“Our winning research underlines how important patients’ first out-of-brace radiographs are for predicting the results at the end of their course of treatment,” Dr Donzelli goes on. “The accuracy of the model we developed and tested, is the key factor that won us this prestigious award, which will allow us to publish our work in the coming months.” 

In the course of the online meeting, several of our specialists gave presentations: Alessandra Negrini, Isico physiotherapist, asked “Is swimming helpful or harmful in adolescents with idiopathic scoliosis?”, Dr Fabio Zaina, Isico physiatrist, gave a presentation entitled “ISYQOL, a Rasch consistent tool for quality of life evaluation in scoliosis patients during adulthood: comparison with the gold standard”, while our director of physiotherapy, Michele Romano, spoke about “The effect of dance performance on idiopathic scoliosis progression in adolescents”.

This is the second year running that Isico has not only been among the finalists but also gone on to win the award. 

In 2019, Isico also won an award with a study concerning scoliosis and sport. “The quality of our research has increased not only as a result of our acquisition of increasingly high-level methodological skills, but also thanks to the growing availability of systematically collected data,” explains Dr Donzelli. “In recent years, the data we routinely collect from patients visiting our facilities have allowed us to develop so-called predictive models. In other words, we consider the characteristics of large groups of patients to try and understand whether they allow us to predict their final results, or whether certain risk factors are more important to consider than others when deciding what type of therapy to prescribe. Our growing clinical and research expertise has led to international collaborations. Many others now look to us to provide expert support. We are also seeing an increase in our collaborations with international partners that want to analyse and compare their clinical and radiographic data with our database”.

Bracing works better in Italy

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Bracing treatment reduces the risk of needing surgery, but the proportion of patients who manage to avoid the scalpel differs between Europe and North America. The factor that makes the difference is patient compliance, i.e. a patient’s adherence to, and belief in, the course of bracing treatment prescribed. In this regard, Italian patients certainly come out on top. 
This is what emerged from a study conducted by ISICO entitled “AIS Bracing Success is Influenced by Time in Brace: Comparative Effectiveness Analysis of BrAIST and ISICO Cohorts”, which has just been published in the scientific journal Spine.

The study was based on a comparison of two populations of patients at high risk of surgery, which showed that, after bracing treatment, 39% of US patients go on to have surgery, as opposed to just 12% of patients treated by ISICO. The Italian institute sent clinical data referring to patients seen by its specialists to the University of Iowa, so that these data might be compared with those obtained in previous research published by the American group in 2014. 

“We worked in collaboration with the researchers at the University of Iowa” explains Dr Sabrina Donzelli, ISICO physician and author of the paper. “In 2014, our American colleagues published a randomized controlled multicentre trial called the “Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)”. The resulting paper, by Lori Dolan and Stuart Weinstein, was published in the New England Journal of Medicine. Their study, the most important on this topic in the past 30 years, involved 383 patients from 25 US and Canadian institutes studied between March 2007 and February 2011. It showed that brace treatment reduced the percentage of patients requiring surgery. Given that surgeons and families in North America have always had a rather negative attitude towards bracing (unlike those in Europe, where it is well received), the authors were surprised by this finding. We took the results of the BrAIST study as the starting point for our research, comparing them with our own data. Working with our American colleagues, we selected patient subpopulations comparable for disease severity and risk of surgery”.

This comparison was a demanding task requiring clarity: the Italian researchers and the American surgeons from the Children’s Hospital of Iowa measured the radiographs of the patients from the BrAIST study and of 169 patients being treated at ISICO, in order to objectively verify the data. 
What did the comparison show? That bracing treatment at Isico works better, with the proportion of at-risk Italian patients who actually had surgery found to be just a third of the proportion recorded in the American population (12% vs 39%). It also emerged that the ISICO patients, respecting the treatment prescribed, wore their brace for a far greater number of hours than their American counterparts.

“Patient compliance is crucial,” Dr Donzelli continues “Our patients are careful to respect their doctor’s prescriptions, and the doctors and patients enjoy a good relationship based on mutual trust and faith in the proposed treatment. All this adds up to great teamwork between the patient, his/her family, the doctor, the orthopaedic technician and the physiotherapist”.

Predicting scoliosis progression: published an Isico review

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The scientific knowledge and the clinical competence of Isico experts recognized by Lancet’s EClinical Medicin Journal

One of the major challenges faced by clinicians is related to Idiopathic Scoliosis prognosis and to decision-making concerning which would be the best treatment for every single patient. 

Precisely on this topic, it has just been published by Isico in the journal EClinical Medicine the commentary Predicting scoliosis progression: a challenge for researchers and clinicians.  The editor invited to comment on the study  “A validated composite model to predict the risk of curve progression in adolescent idiopathic scoliosis”, following the review of the same conducted by Dr. Donzelli for the journal.

Idiopathic scoliosis has a multifactorial aetiology showing a wide range of different forms: anatomical (single or multiple curves and different localization), aesthetical (milder curves with visible changes and severe hiding perfectly), and prognostical (from highly to non-progressive).

Experts use some known clinical risk factors, the most important being residual growth: the more it is, the more the risk.

“It has been shown that ending growth below 30° allows preventing progression, disability and pain in adulthood – explains dr. Sabrina Donzelli, physiatrist in Isico and author of the review – the study of these colleagues developed a predictive model of the progression of scoliosis beyond 40 degrees, combining both clinical data and data from genetic tests. The idea of ​​combining clinical and genetic factors is interesting, but the results show that genetic testing does not play as significant a role as clinical data. The test of the accuracy of the model showed 80% of specificity and 92% of sensitivity, thus meaning that the model is good in discriminating patients at high risk for progression to 40°. According to the model, there is a 20% risk of overtreating patients with less aggressive IS. Is this enough? It depends on the treatment used to avoid progression”. 

The study therefore conducted is undoubtedly interesting, but the researchers showed a fundamentally surgical approach without any reference to the preventive role of the worsening and surgical risk shown by conservative treatments. Therefore we have been invited to process a comment to associate with the publication.

We would like to remind you that the SOSORT Guidelines recommend that ” for each patient, it is mandatory to choose the correct step of treatment, where the most efficacious is also the most demanding.” Expert clinicians should always choose the option they think is the most likely to reach the goals agreed with the patient but also the less invasive in the attempt to balance between undertreatment (that leads to little or no efficacy) and overtreatment.

“The introduction of a composite model, including genetic factors, is the novelty of this study, but some clinical questions remain open – continues dr Sabrina Donzelli – The type and quality of treatment applied, the compliance to treatment and the dosage of brace-wear have not been included in the model, although they are recognised as determinants of final results”.

From a clinical point of view, the 40° threshold is too low for surgery indication and too high for the best achievable result from patients’ perspective. Surgery is indicated for curves exceeding 50°.  

“A prognostic model should help clinicians in their choices after risks estimation – finalises dr Sabrina Donzelli – the currently developed composite prediction model for progression over 40° showed that the major predictor is Cobb degrees at start. The fact that Cobb at start is the major predictor, confirms the key-role played by screening and conservative care: exercises and bracing to prevent progression should be started at early stages of the deformity when it is early diagnosed“. 

Dr Donzelli at Oxford University

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Dr Sabrina Donzelli, an Isico physician, participated some weeks ago in a joint programme in collaboration with the Centre for Evidence-Based Medicine in Oxford, together with other 15 students coming from Egypt, Brasil, Ireland, UK, USA, Ghana, Canada, Hong Kong, Malaysia, Lebano and Italia.

The topic of this demanding course was basic and advanced statistical methods for meta-analysis for health professionals designed to provide an overview of different meta-analysis methods and common problems encountered with extracting data. The module is part of the MSc degree in Medical Statistic provided by the department in  Evidence Based Health Care at Oxford University, Dr. Donzelli was admitted to the program in the Academic year 2019. 

Dr Donzelli is currently a teaching assistant for the online program in Principle and Practice in Clinical Research provided by the Harvard University gathering every year more than 400 students from all around the world.