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Adherence to treatment: the abstract for Sosort Conference

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“Adherence to Physiotherapeutic Scoliosis-Specific Exercises during adolescence: voices of patients and their families. A qualitative content analysis” is one of the 8 studies being presented by ISICO during the forthcoming SOSORT international conference in Melbourne, Australia.
Its purpose was to explore the experience with PSSE of adolescents with spinal deformities and their parents, and their insights on how to assess the quality and frequency of PSSE performed at home.
The study is the exploratory phase of the development of a new Rasch-consistent questionnaire to assess adherence to PSSE in adolescents with spinal deformities. 

“The efficacy of specific exercises for scoliosis is closely linked to patient adherence to the treatment programme,” says Dr Irene Ferrario, ISICO psychologist and author of the study. “Treatment adherence is a complex concept, as it is the result of the interaction of various factors associated with patients, families, therapists and the treatment itself. Managing to identify the factors that promote or prevent treatment adherence is crucial in order to help youngsters get the best possible result. In this study, we set out to look at how our patients and their parents get on with scoliosis exercises, and examine their ideas on how the quality and the quantity of exercises done at home might be assessed”.

How did we collect the data? The researchers sent 2699 patients a questionnaire made up of open questions designed to collect thoughts and experiences with respect to adherence to a home exercise programme; 110 adolescents and 93 parents filled in the questionnaire anonymously. On the basis of what they wrote, we identified the five main categories of factors that can facilitate or hinder treatment adherence: “Organisation of time and space”, “Help tools”, “Understanding the therapeutic goals”, “Loneliness”, and “Nature of the exercises”.  

The most commonly reported facilitating factors were: using an app specially developed by ISICO, being able to listen to your favourite music while doing the exercises, being able to decide when to schedule the home sessions, and certain characteristics of the exercises (e.g., easy, fun, not requiring specific instruments). The factors most commonly deemed to hinder treatment adherence were lack of time, lack of motivation, lack of feedback from the physiotherapist, and type of exercises (i.e., boring ones).

“Patients and their families know what can help or interfere with their adherence to a home exercise programme for scoliosis” Dr Ferrario concludes. “Listening to what they have to say about the various factors that can hinder or facilitate them in this regard can help physiotherapists to develop exercise programmes tailored to patients’ specific needs and offer solutions and strategies to overcome common problems, thereby helping youngsters to more easily achieve the goals of the treatment.”

Why the therapeutic team is part of the treatment

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Scoliosis treatment, whether we are talking about exercises alone or also bracing, can be an uphill battle in which adherence to the therapy itself is always fundamental. 

“A famous study conducted in the US and published in 2013 (Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct.) confirmed beyond doubt the effectiveness of brace therapy in arresting the evolution of idiopathic scoliosis. And the patient’s adherence to the treatment was the factor that most influenced the result,” underlines physiotherapist Alessandra Negrini.

To ensure that a youngster manages to be collaborative in carrying out this demanding therapy, especially considering that it is often undertaken during early adolescence which is a notoriously tricky time, it is essential that all those interacting with the patient and with their family make sure they are always on the same page, giving clear and consistent messages.

With this in mind, it is easy to see why the therapeutic team, by encouraging patient compliance, plays such an important role in achieving the goals set.

Educating children and parents means explaining the nature of the disease, together with its possible course and potential consequences, setting and explaining realistic therapeutic objectives and rules to follow while performing physical (including home-based) exercises, and ensuring that there is cooperation with the physiotherapist and physician supervising the treatment. Specific physiotherapeutic exercises should be conducted by a trained and certified physiotherapist operating within a therapeutic team that includes a psychologist, orthotist, orthopaedist, and medical rehabilitation specialist.  

The team that takes on the patient’s care needs to manage to lighten the burden of the treatment, and help the patient and their family to cope with the situation. 

Within the multidisciplinary team, the physiotherapist is the patient’s point of reference, the one who motivates and, when necessary, re-motivates them. The physiotherapist is also the linchpin of the team itself.

 “In view of this important role, the physiotherapist should always bear in mind three key rules that I always think of (in Italian) as the 3 As, explains physiotherapist Marta Tavernaro. The first “A” stands for addestrare (coaching), which reminds me of the need to explain to patients what is happening to them, what scoliosis actually means, and how we and they can prevent it from getting worse. The second “A” stands for approccio (approach), which in this case means being enthusiastic about what we are doing and conveying this to the patient; the third “A”, both in Italian and English, stands for “acquire”, in the sense of collecting the information you need to know whether the youngster in your care has been working effectively.”

During the rehabilitation process, the therapist may become aware of specific problems concerning the family and/or the young person that could jeopardise the treatment. The psychologist is the team member ideally placed to manage these difficulties.

In this regard, it is important to remember that this course of treatment is followed in what is already a difficult and delicate life stage, characterised by sudden changes that influence the young person’s developing personality and how they view their role in society: all of this can have important repercussions on the therapy.

“When we are working within a biopsychosocial model of care, we must of course also keep the psychological aspects in mind,” points out ISICO psychologist Dr Irene Ferrario. “In this case, adopting a person-centred approach means not only measuring the individual patient’s Cobb angle, but also taking into account their emotions and feelings at this particular time in their life. When the doctor or therapist senses that there is an underlying problem, they seek the intervention of the psychologist on the team, who, through individual counselling or psychotherapy, will probe and identify the factors responsible for the change.”

An ISICO study published a few years ago (Importance of team to increase compliance in adolescent spinal deformities brace treatment: a cross-sectional study of two different settings) highlighted the role of the therapeutic team. As pointed out by one of the authors, ISICO physiatrist Dr Andrea Zonta, “the concept of compliance has to be understood in a broad sense, and therefore as adherence not so much to the use of the brace or the prescribed programme of exercises, as to the entire therapeutic pathway, which can last years. After all, we will not obtain lasting results if we think we can intensify the exercises for a certain amount of time and then just abandon them”.
In our research, the population was split into two groups according to the setting in which the treatment was performed and the two groups were administered two questionnaires: the SRS-22 [3, 4], and another, specially developed, one (QT) with 25 multiple choice questions about adherence to treatment (sections: brace, exercises, team).In fact, since the population was chosen as having been treated by the same orthotist and physician, the only distinction between the two populations was in the physiotherapeutic and general team approach.

“If the therapeutic team is not working properly, and I refer particularly to the professionals involved, there is a great risk of pain and decreased QoL. The same is true with regard to compliance with bracing” concludes Dr Zonta. “Moreover, this study has shown that the SOSORT management criteria can be important for brace treatment. The results seem to confirm that the management of patients is sometimes neglected, probably because it is an aspect not understood or perceived by the people involved; nevertheless, effective patient management could (through increased compliance) be a main determinant of the final results and/or the patient’s immediate QoL”.

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”. 

A closer look at the data

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The study just published, A Pragmatic Benchmarking Study of an Evidence-Based Personalised Approach in 1938 Adolescents with High-Risk Idiopathic Scoliosis, focused on 1938 participants with AIS, Cobb angles of 11–45°, and Risser stage 0–2, who were studied until the end of growth. 

Using the inclusion criteria reported in existing RCTs on physiotherapeutic scoliosis-specific exercises (PSSE), plastic bracing (PB), and elastic bracing (EB), we benchmarked 590, 687, and 884 members of our study population, respectively.
The study showed EBPA to be from 40% to 70% more effective than benchmarked individual treatments, with a low number needed to treat (NNT). 

“We evaluated clinically significant results and burdensomeness of care, calculating the relative risk of success and the NNT for efficacy”, explains Dr Sabrina Donzelli, Isico physiatrist who contributed to the data analysis. “In randomised studies, patients are randomly allocated to one treatment or another, to ensure that all patients have the same probability of being treated or observed. This randomisation process is necessary to rule out factors (such as physician choice of treatment) that could affect the outcome. We compared our PB, EB, and PSSE subgroups with the corresponding paired RCTs for benchmarking purposes. The probability of success in patients treated in EBPA is between 1.5 and 3.5 times that of natural history and between 1.2 and 2.9 when compared to per-protocol treated groups. Although surgery could not be avoided completely, only 2% of our patients ultimately needed it, compared with 28% of those belonging to the comparison studies’ untreated control groups”.

Patient compliance is the factor underlying the significant difference in these results. 

A comparison of the Chêneau and Sforzesco braces

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Unfortunately, it has become common to think of braces in the same way as we do drugs. But before we go any further, we need to make one thing clear: whereas we all know that aspirin is not the same as paracetamol, in the case of a brace, the name doesn’t really mean anything specific.
A brace is a product that is made-to-measure for the individual patient, and therefore the success of bracing treatment depends not on the name of the brace, but on how correctly it has been constructed for the particular patient. If the pads are incorrectly positioned, or if the brace is constructed so that it sits too low or presses too much on one side, it may even contribute to worsening rather than improving the scoliosis. 

The names of the different braces, therefore, are meaningful only to those who prescribe them. 

Finally, adding to the confusion, Dr Chêneau gave his name to two completely different types of brace: the first Chêneau is much more symmetrical than the second one, which, on the other hand, is clearly asymmetrical. Although the second Chêneau brace is the one most commonly used worldwide, we prefer to use the first one, for two reasons: first of all, it is discreet (practically invisible under clothes) and second, in constructing it, we are able to apply the same principles that characterise the Sforzesco, which is the brace developed at our own centre. For this reason, the Chêneau that we use at Isico has been given a new name: we call it the Sibilla- Chêneau, in honour of Dr Sibilla, a pioneer of our school.

So, how do the Sibilla-Chêneau and the Sforzesco differ? They differ in several features, which determine the choice of one over the other on a case-by-case basis. The decision to prescribe one type of brace rather than another must always be taken by a medical specialist.

Let’s start with the material: the Sibilla-Chêneau, used at Isico, is of monovalve construction and it is made of polyethylene, whereas the Sforzesco has two valves and is made from a much more rigid material. Its two parts are linked to posterior fasteners, and there is sometimes an aluminium rod at the back, too. Being more rigid, the Sforzesco has shown the same efficacy as the old system of plaster casting, but with the huge advantage of being removable for bathing/showering.

The Sibilla-Chêneau tends to be used to treat milder cases with less rigid scoliotic curves; it is also preferred for pre-pubertal patients. The Sforzesco, on the other hand, is used for more severe scoliosis with more rigid curves (for example, in youngsters with greater bone maturation). 

In some cases, patients start off with a Sibilla-Chêneau brace but subsequently switch to a Sforzesco one if the scoliosis becomes too aggressive (a decision reflecting the concept that the treatment should evolve gradually): on a hypothetical treatment scale, we can say that the Sforzesco (a super-rigid brace) is one step up from the Sibilla-Chêneau (a rigid brace).

At Isico, both these braces are prepared in accordance with the SPoRT (Symmetrical, Patient-oriented, Rigid, Three-dimensional) concept of bracing.

 “Symmetrical” means that the brace, externally, appears almost perfectly symmetrical, which makes it unobtrusive and helps to replicate the natural shape of the human body. In other words, for aesthetic reasons, it is outwardly symmetrical. By contrast, internally the brace acts asymmetrically, exerting a three-dimensional corrective action on the deformity. 

The brace is defined “Patient-oriented” on account of its wearability, and therefore tolerability. Being very closely fitting, it moves with the patient, and it does not restrict arm and leg movements at all. Furthermore, since it is easy to conceal, patients accept it readily, rather than merely putting up with it.

The term “Rigid” refers to the type of material used.

Finally, “Three-dimensional” refers to the corrective action of this type of brace on the spine; technically speaking, the brace pushes in a down-up direction; overall, the transmission of the corrective forces to the spine is carefully balanced in such a way as to obtain optimal correction in all three planes of space, without any of the three being allowed to dominate.

As explained at the start, another type of Chêneau brace is also used worldwide; in Italy, we call this the Chêneau 2000: it is an asymmetrical brace that uses expansion chambers. It remains clearly asymmetrical, even externally.  We, on the other hand, prefer to use the symmetrical version of the Chêneau, in order to respect the SPoRT concept mentioned above and also because it favours compliance. Indeed, applying our school of thought, we have obtained, in our patients, the best bracing results recorded anywhere in the world, and this is thanks, in part, to the type of braces we use. Naturally, braces only work if patients actually wear them, and the easier they are to conceal under clothes, the more patients will wear them.

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”.