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Dr. Sabrina Donzelli, the next president, tells us about the SOSORT conference

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Once again, the international SOSORT conference was one of the most important appointments for our institute (eight abstracts were presented), and with a cherry on top, the fifth SOSORT Award was won!
We asked Dr Sabrina Donzelli, physiatrist and president of SOSORT in 2024, the first woman to hold this position, to tell us something more about the event, given that she was one of the three Isico specialists present in Melbourne (the others were Dr Fabio Zaina and our director of physiotherapy, Michele Romano).

1) What did participating in this event mean to you?
For the first time, SOSORT participated in Spineweek. Spineweek is an event that occurs every four years and brings together many societies dedicated to various aspects of the spine. This event allows participants to follow different companies by participating in a single event. It provides the other companies involved greater visibility or the possibility of being known and attracting new members.
The event was a success for SOSORT thanks to the number of participants and presentations. SOSORT is growing, and this experience was another opportunity for growth for the company, which is preparing to organize its first annual congress with total autonomy.

2) What were the major scientific innovations?
Dr Angelo Aulisa presented a remarkable study on the efficacy of braces in patients with Scheuermann with a 10-year follow-up. It is the first study to explore this area with such an extended follow-up.
Comparison studies are starting to emerge, for example, between braces at different dosages or nighttime bracing compared with exercises only; unfortunately, the quality of these studies is limited, and the results still need to be evaluated with caution.
We are also witnessing an increasing collaboration between surgery and rehabilitation treatment in a great communication effort to learn how to manage better patients who have surgical indications and those who would like a surgical approach but could benefit from conservative treatment. The president of the SRS (Scoliosis Research Society), Dr Serena Hu, showed the innovations in the surgical field; indeed, there are still many challenges to reducing invasiveness with the same effectiveness.

3) The SRS also has a female president for the first time, and your successor in the SOSORT presidency is the Croatian doctor Suncica Bulat Wuerching. There are more and more women, so how are you experiencing this moment of transition to your presidency?
We women play a fundamental role in the scientific world, like our colleagues, and this can only fill me with satisfaction for the work we carry out with great determination and professionalism. In terms of my position, it will be a great responsibility to lead the company through this transition. Still, I am delighted to work with a fantastic team of professionals, starting with the current president, James Wynne.

Isico’s research wins the SOSORT Award

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For the fourth consecutive year, Isico has obtained the most prestigious award for those involved in rehabilitative treatment of the spine, winning the SOSORT Award with the study Prediction of Future Curve Angle using Prior Visit Information in Previously Untreated Idiopathic Scoliosis: Natural History in Patients under 26 Years Old with Prior Radiographs.

The research, which involved 2317 patients with idiopathic scoliosis between 6 and 25 years old, was developed by our researchers (the Isico authors are Prof. Stefano Negrini, together with Dr Giulia Rebagliati, Dr Fabio Zaina, Dr Sabrina Donzelli and Dr Alberto Negrini) in collaboration with Dr Erik Parent of the University of Alberta, Canada. This project was funded by a Standard Research Grant from the Scoliosis Research Society.

“Understanding natural history helps inform the treatment selection for modifying the course of the disease or to avoid overtreatment – explains prof. Stefano Negrini, Isico Scientific Director- Previous models predicting curve progression lacked validation, did not include the full growth spectrum or included treated patients. Our aim was to develop and validate models to predict future curve angles using clinical data collected only at, or both at and prior to, an initial specialist consultation in idiopathic scoliosis”. 

Scoliosis-specific exercises are recommended in small curves in skeletally immature patients, exercises and progressively more aggressive brace treatments are recommended for moderate and severe curves in 10% of growing children and adolescents and invasive corrective surgery is recommended in severe curves at risk of continued progression in adulthood for 0.1-0.3% of cases. 

“Patients were previously untreated and provided at least one prior radiograph prospectively collected at first consult – continues prof. Negrini – We excluded those previously treated”.

 Radiographs were remeasured blinded to the predicted outcome: the maximum Cobb angle on the last radiograph while untreated. Linear mixed-effects models with random effects and maximum likelihood estimate were used to examine the effect of data from the oldest visit (age, sex, maximum Cobb angle, Risser, and curve type) and from other visits while untreated (Max Cobb angle), and time (from oldest radiograph to prediction) on the Cobb angle outcome.

“Predictions models were proposed which can help clinicians predict future curve severity expected in patients not receiving treatment –ends prof. Negrini – Predictions can inform treatment prescription or show families why no treatment is recommended. Our models offer the flexibility to predict at a future timepoints over the full growth period. These validated models predicted future Cobb angle with 80% of predictions within 100 in non-treated idiopathic scoliosis over the full growth spectrum. Improved prediction ability may help clinicians inform treatment prescription or show families why no treatment is recommended”.

SOSORT 2022: the AWARD winners and a fourth ISICO President

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This year’s SOSORT meeting, held in San Sebastian, Spain in the wake of two editions forced online by the pandemic, was a double success for ISICO, which had two studies shortlisted for the SOSORT Award.
One of them, Prediction of Future Curve Angle using Prior Visit Information in Previously Untreated Idiopathic Scoliosis: Natural History in Patients under 26 Years Old with Prior Radiograph, conducted in collaboration with the University of Alberta in Canada, came first, making this the fourth consecutive year that ISICO has taken home the prestigious award. But this was not the only high point. Our Dr Sabrina Donzelli, physiatrist, was named as the next President of the International Society. This is the fourth time that ISICO has had this has honour since SOSORT was founded in 2004,  and it is the first time a woman has been appointed to the role.

“This prestigious appointment is an acknowledgement of Dr Donzelli’s scientific standing, hard work and commitment, as well as a recognition of our institute, which now provides a benchmark for clinical and research activity worldwide” remarked Prof. Stefano Negrini, Scientific Director of ISICO as well as one of the ISICO authors — the others being De Giulia Rebagliati, Dr Fabio Zaina and Dr Alberto Negrini — who collaborated with Dr Eric  Parent, first author of the study that won the SOSORT AWARD. The congress was hugely stimulating and we can’t wait for 2023 and next year’s meeting in Melbourne, Australia”.

Ready for SOSORT

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There are just a few days and the SOSORT  International Conference finally, after two years from the start of the pandemic, is back in person in San Sebastian, Spain from the 4th to the 7th of May.
It will be the usual pre-course, scheduled for May 4, to kick off the event: three of our specialists will participate in the round table, Dr Fabio Zaina, with a session on Overview of Adult Spinal Deformity classification, and how it is differing from AIS, Dr Sabrina Donzelli with  ASD prevalence and Dr Michele Romano, director of Isico Physiotherapy, with Standardized presentations describing assessment, clinical decision making process and treatment.

In the following days, Isico will be present again with three presentations: Dr Fabio Zaina will present on May 6th “Night-time bracing improves back pain in patients with painful scoliosis: six months results of a retrospective controlled study“, Dr Michele Romano on May 7th “Exercises for adolescent idiopathic scoliosis: Updated Cochrane Review”  and finally, Prof. Stefano Negrini, scientific director of Isico, will compete for the SOSORT Award with his research “Splitting Growth into 3 Phases with Cut-offs at Pubertal Spurt and Risser 3 Facilitates Prediction of Progression. A Study of Natural History of Idiopathic Scoliosis Patients from age 6 to End of Growth”.

For more info: https://sansebastian2022.sosort.org

The winning study of the SOSORT Award 2020 has been published

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Two years after winning the SOSORT AWARD, the study “Predicting final results of Brace Treatment of Adolescents with Idiopathic Scoliosis: First Out-of-Brace are Better than In-Brace-radiographs” has finally been published in the European Spine Journal.

 A total of 131 patients were included in the study, the researchers aimed to determine which of the two radiographs is the best predictor of the Cobb angle at the end of treatment (final radiograph). In fact, the in-brace radiograph of adolescents with idiopathic scoliosis (AIS) has been shown to reflect brace efficacy and the possibility of achieving curve correction. Conversely, the first out-of-brace radiograph could demonstrate the patient’s ability to maintain the correction.

The first out-of-brace radiograph predicts end results better than the in-brace radiograph.

“Our research has highlighted – explains Dr. Sabrina Donzelli, author of the research – how important the first x-ray taken without the brace is in predicting end-of-care results. The first out-of-brace radiograph should be considered an essential element of future predictive models and offers an excellent clinical reference for clinicians and patients. The collection of clinical data that occurs routinely during all visits to ISICO has allowed in recent years to be able to develop the so-called predictive models, i.e. we can use the characteristics of the patient to understand how the final results can be predicted or to understand if there are risk factors more important than others to consider when deciding what type of therapy to prescribe “.

Brace wearing: tenacity is rewarded with improvements

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It is not just a question of how many hours the brace is worn but also patient compliance with the prescription. Take, for example, Marco and Ginevra. Both have idiopathic scoliosis, are followed by Isico specialists, and wear a Sforzesco brace for 20 and 23 hours a day, respectively. Marco complies with the prescription for wearing the brace, but he is inconsistent with the prescribed hours: sometimes he wears it for the 20 hours prescribed, others for 10, and others for 22. Ginevra instead regularly respects the prescription of 23 hours daily; this allows her to attain better results and avoid worsening.

Our study demonstrates this, Consistent and regular daily wearing improves bracing results: a case-control study published in the journal Scoliosis and Spinal Disorders some years ago. The study considered 168 patients who wore a brace for between 18 and 23 hours per day, divided according to high, medium, or low compliance and classified according to consistency or inconsistency in wearing.
The data were collected using Thermobrace, a temperature sensor applied to the brace to monitor its actual wearing.

Isico was the first organization to introduce Thermobrace into the daily clinical routine in 2010, and since then, its use has become commonplace. It has been verified that the relationship between doctor and patient is strengthened through Thermobrace, since the therapeutic choices are based on real data; therefore, the data obtained from the sensor can be used to facilitate the use of the brace.

“The data confirmed that the brace should be worn consistently, which means that wearing the brace for a constant number of hours allows the achievement of good results,” explains Dr Sabrina Donzelli, physiatrist and author of the publication, “also for those who are not completely compliant to the prescribed hours”.
This confirms what we always recommend to patients who undergo brace therapy: the break must always be constant; fewer hours one day and then recovering the lost hours in the following days is not ideal!

In addition to not adhering to the prescribed treatment, patients who are also not consistent in wearing the brace are at greater risk of worsening. Patients who have worn the brace for less than 70% of the prescribed duration are considered non-compliant.
“The study shows that to achieve the best results, the brace must be worn for a consistent number of hours. The attempt to recover lost hours is useless,” concludes Dr Donzelli “While tenacity together with compliance, i.e., the adherence of the patient to the prescription, is rewarded”. 

The importance of observational studies

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Our study, Observational Studies: Specific Considerations for the Physical and Rehabilitation Medicine Physician, was recently published in the American Journal of Physical Medicine & Rehabilitation. 

Experimental and non-experimental designs are used to investigate the effect or association of an intervention and clinical or surrogate outcome. These methods aim to improve knowledge and develop new strategies to manage a disease or condition. 

While experimental research studies entail scrutiny by the scientist and provide results that are less prone to systematic errors, their downside is that they are poorly generalisable. “What all this means in clinical terms,” explains Dr Sabrina Donzelli, physiatrist at Isico and first author of the published research,” is that a treatment that worked fine during a study may in the long term, following its prescription by a hospital or general practitioner, throw up problems that did not emerge in the experimental research”. 

Therefore, to verify what happens in the real world, non-experimental studies, called observational studies, can be carried out, of the kind dealt with by the research we have just published. 

Well-designed observational studies can provide valuable information regarding exposure factors and the event under investigation. 

“Basically, what the researcher does is simply observe data, without having the possibility to manipulate it”, Dr Donzelli goes on. “The researcher’s task is to interpret and contextualise the results, taking into account all potential errors introduced during the selection of the study sample. To eliminate, as far as possible, systematic errors that could lead to incorrect evaluations and interpretations, it is necessary to implement a series of methodological strategies that are not very widespread in the rehabilitation field.” 

In physical and rehabilitation medicine, where complex procedures and multiple risk factors can be involved in the same disease, the use of observational study must be planned in detail and a priori to avoid overestimations. 

“This is why we wrote this article, to offer clear suggestions to researchers in the rehabilitation field who are interested in planning an observational study”, concludes Dr Donzelli. “We give an overview of the methods used for observational design studies and describe when it is appropriate to use them and how to do so in different scenarios”. 

eSosort2021: Isico competes for the AWARD

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Isico, too will be present with several presentations at the annual international conference Sosort, online from April 29th to May 1st.
A presence, albeit virtual, characterized by the possibility of competing again for the SOSORT Award. We recall that Isico has been awarded already in the last two years the prestigious international recognition given by SOSORT for the best research, to which is added, in 2019, the Award won as co-authors of a research study in collaboration with the University of Hong Kong.

“In this online edition, our study Efficacy of bracing in infantile scoliosis. A 4-years prospective cohort shows that idiopathic respond better than secondary scoliosis will compete for the Award along with six other studies – explains Prof Stefano Negrini, scientific director of Isico and first author of the research – an important result that recognizes the high quality of the research we are performing in Isico. Also, the study Adults with idiopathic scoliosis: progression over 5 Cobb degrees is predicted by menopause and metabolic bone disease, which sees as first author Dr Sabrina Donzelli (who won the Award in 2020) was nominated among the 7 best research studies: Dr. Donzelli will hold the presentation but will not compete for the Award this year.”
In addition, another study, Increasing Brace Comfort, Durability and Sagittal Balance through Semi-rigid Pelvis Material does not change Short-Term Very-Rigid Sforzesco Brace Results, is among those selected for the Podium presentation and will be presented during the event by Dr Francesco Negrini, an Isico physiatrist.

Isico also distinguished itself for the works accepted as Posters, available to subscribers to the event in an on-demand session, and they are three: Can the tilt-differences of limiting vertebrae be a prognostic factor for the worsening of the scoliosis curves treated with specific exercises? A pilot study using a series of matched patients, edited by our director of physiotherapy, Michele Romano, Reducing the pelvis constriction changes the sagittal plane in the brace. A retrospective case-control study of 37 free-pelvis vs 336 classical consecutive very-rigid Sforzesco braces and The modular MI-brace is as effective as the classical custom-made Sforzesco brace. A matched case-control study of 120 consecutive high-degree female AIS, both from Prof Stefano Negrini.

This year’s virtual meeting will begin with synchronous (live) presentations on Thursday, April 29th and Friday, April 30th, from 9 am to 11 am Eastern Time, and on Saturday, May 1st, from 9 am to 1 pm Eastern Time.

All the presentations will be recorded and be made available on-demand for a duration of 1 year on the SOSORT conference website for registered participants. For more information and registration, visit the event website https://esosort21.sosort.org

SRS research evaluates AIS brace management

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The research Scoliosis Research Society survey: brace management in adolescent idiopathic scoliosis has just been published by the journal Spine Deformities. While the Scoliosis Research Society (SRS) has established criteria for brace initiation in adolescent idiopathic scoliosis (AIS), there are no recommendations concerning other management issues. As the BrAIST study reinforced the utility of bracing, the SRS Non-Operative Management Committee decided to evaluate the consensus or discord in AIS brace management developing this research.

1200 SRS members were sent an online survey in 2017, which included 21 items concerning demographics, bracing indications, management, and monitoring.

218 SRS members participated in the survey: 207 regularly evaluate and manage patients with AIS, and 205 currently prescribe bracing.  99% of respondents use bracing for AIS and the majority (89%) use the published SRS criteria, or a modified version, to initiate bracing. 85% do not use brace monitoring and 66% use both Cobb correction and fit criteria to evaluate brace adequacy. 

“From the research it emerges that in practice the variability is very large – explains Dr Sabrina Donzelli, physiatrist and researcher at Isico – the treatment protocols, the hours of wearing, the time elapsed between visits, the radiographs required, with or without brace, with what times and after how many hours of break, the brace-weaning protocols, vary considerably from one specialist to another”.

In the United States, the use of braces is recent, it spread after the publication of the results of the BrAIST study: “The management of therapies and treatments is affected by the inexperience of specialists – continues Dr Donzelli – often the indications given to patients are not precise, they are not justified by the objectives of the treatment and they are not supported by strong motivations deriving from clinical experience. Or at least this is what emerges from the survey “.
What then is the conclusion of the research? 
This variability may impact the overall efficacy of brace treatment and may be decreased with more robust guidelines from the SRS. Furthermore, brace therapy must be personalised in a pathology so complex that it cannot be simplified: “The dosage with which the brace is prescribed must be correlated with the therapeutic goal to be achieved – states Dr Donzelli – Risser 0, 1 or 2 is characterised by different progression risks, the extent of the starting curve changes the treatment objectives: sometimes it is necessary to improve the curve, sometimes it is enough to stabilise. The type of brace to be used varies according to the type of curve, their localization and the estimated evolutionary risks of the curve correlated with the problems in adult life. I want to add to the research  – concludes Dr Donzelli – that they only considered the use of the brace, nothing is said about the role of exercises, of which several research studies have efficacy already proven, alone or in association with the brace itself as for example these articles https://pubmed.ncbi.nlm.nih.gov/25729406/ and https://pubmed.ncbi.nlm.nih.gov/30145241/ published by Isico”.

Natural History of Scoliosis: the development of a predictive model

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There are two abstracts on the natural history of scoliosis that Isico is going to present at the 56th SRS conference scheduled for next September in the United States: “Predicting Future Curve Severity for Juvenile Idiopathic Scoliosis: A Natural History Study” and “Predicting Future Curve Severity Requires Different Models for Adolescent and Juvenile Idiopathic Scoliosis “.
Abstracts which constitute research carried out by Isico in collaboration with the Canadian University of Alberta and Dr Erik Parent. The preliminary results of this research study will be presented by Prof Stefano Negrini at the Research Grant Outcome Symposium organized by SRS and scheduled for March 6 from 9 to 11 ET US.
Most models to predict future Scoliosis severity have not been validated; many previous samples included treated patients limiting our understanding of the natural history. 

“Our aim was to predict future curve severity at a time point of the clinician’s choice during adolescence using data from x-rays obtained before starting treatment in patients with a diagnosis of Juvenile Idiopathic Scoliosis (JIS) – explains dr Sabrina Donzelli, one of the authors of this research study – we included 2331 patients with a diagnosis of JIS, under age 26, previously untreated.
The data obtained through the radiographs confirm the factors involved in the severity of scoliosis: for juvenile scoliosis the age at onset and the extent of the curve, and for adolescent scoliosis the Risser stage and female gender. The idea is to optimize the use of this data for clinical purposes “.

That is, to be able to validate the model to verify  whether it works for another population with similar characteristics. “During the webinar to which I have been invited – says Prof. Negrini – I will present the preliminary data not only of the two abstracts but also of the other analyses developed by the Canadian university. As a team, we are continuing to validate one model with which we can create an algorithm to predict the cases with the highest development risk.”