Will the Covid emergency finally teach us the importance of scientific evidence?

Many people are saying that the present coronavirus epidemic will change our whole way of being: our relations with others and the way we see things. Indeed, this health emergency has forced practically all of us to change our habits and our way of life.

Perhaps we should therefore also be asking ourselves whether, in the post-Covid age, there will be greater recognition of the health sector and a greater understanding of the importance of the scientific community, research and evidence-based investigations.

Just think about it. Today, we are all anxiously waiting for an anti-Covid vaccine, whereas not so long ago (although it feels like a lifetime) there were parents who were choosing not to vaccinate their children with drugs that have been available on the market for many years and that countless studies have shown to be effective.

It is to be hoped that, in the wake of this emergency, it will be clear to everyone that infectious diseases (i.e. diseases that are passed from person to person) are only truly brought under control when most of the population is immune to them, in other words when there is so-called herd immunity. This situation is reached when a large section of the population has either been vaccinated against the disease or exposed to the virus and developed antibodies against it.

Unfortunately, there is plenty of incorrect information circulating at the moment. This includes, on a medical level, numerous false beliefs and myths that are difficult to eliminate. These ideas are spread in different ways: via media channels, by word of mouth or even, in some cases, by poorly informed healthcare workers. Some of the ideas going around might raise a smile, but what is less amusing is that they are sometimes heeded and applied by people without the necessary education and expertise to recognise them for what they are.

The Italian Health Ministry has warned people to beware of the various fake news currently circulating about novel coronavirus infection, debunking myths concerning Ayurvedic therapies, yoga and breathing exercises — these are claimed to offer protection against the virus —, the idea that it can be sweated out of the body during physical exercise, and even the claim that honey exerts a useful antibacterial and disinfectant action.

There is a common saying used in science: “In God we trust, all others must bring evidence”. Because what assumes scientific validity must first be proven.
The basis of all evidence-based medicine is the same: scientific studies in which data have been collected and methods and results rigorously compared and analysed by the various experts on the topic in question. A good doctor must always seek to integrate the best scientific evidence from research with the patient’s clinical experience and values. Patients, in turn, must be fully informed about the treatments they are about to undertake.

But the trouble is, many people today tend to lack scientific culture, and few really appreciate the value of “scientific evidence”. Simply trusting in the views of a certain doctor, or the experiences of someone we know, is really no way to drive advances in medicine.

In rehabilitation, as in other branches of medicine, there exist various methods and techniques whose efficacy has been little explored, and others that have no valid medical basis and are quite often administered by people without proper qualifications, who therefore lack the right approach.

For example, numerous studies have shown that simply telling patients “what a terrible back you have!” will only aggravate their tendency to catastrophise and increase their fear of movement, two factors that contribute to the chronification of back pain. 

Similarly, reading on an MRI report that your spine has several protrusions or thinned discs is no more significant than being told that you have lots of grey hairs: the fact that you have a hernia is meaningless unless this information is correctly set within the overall clinical context. What we are saying is that it is the medical specialist’s job to make the diagnosis and prescribe a course of rehabilitation, which the therapist then decides how best to implement in the individual patient.

In the literature, there are various studies showing that some subjects with spinal hernias are completely asymptomatic. Unfortunately, however, we still have patients who come to us either alarmed to have learned they have a hernia or convinced that their osteopath, by manipulating their spine, has managed to “put back” a decades-old hernia.

At ISICO, we treat disorders of the spine, a field closely related to the concept of posture. Postural problems, too, are frequently addressed using approaches whose effectiveness may not have been properly demonstrated.

While this does not always create problems, in some cases, it costs patients valuable time and money, delaying the reaching of a correct diagnosis and proper planning of their care.

Take scoliosis, for example, a condition that tends to worsen with growth: it is one thing starting the treatment when the patient has a curve measuring 20°, quite another waiting until it has reached 40°. The treatment options, by this stage, are drastically reduced, and there is the risk of having to resort to more invasive therapies. Clearly, it is a shame for this situation to have been reached simply because an appropriate treatment was not proposed sooner.

At the courses we run, we are often asked, both by patients and colleagues, whether there is any link between scoliosis and mastication, dental occlusion, and foot and/or knee position/alignment. For the moment, all these ideas are theories with no scientific basis. It could be that, in the future, data will be collected that confirm these correlations and we will be prompted to review our position, but as things stand, it is not ethical to propose treatments based on these theories.

As regards the treatment of scoliosis, the current scientific literature tells us that we have different avenues that we can pursue: observation, exercises, bracing (with different types of brace, for different numbers of hours per day) and, in the most severe cases, surgery.

It is crucially important to offer the patient the right treatment, where “right” means that it is supported by scientific evidence of its effectiveness. Specific exercises for the back, including self-correction ones, are an active and important part of scoliosis treatment, as well as scientifically proven to be effective (“Specific exercises reduce the need for bracing in adolescents with idiopathic scoliosis: a practical clinical trial“). Instead, gymnastics generally, like other physical activity, has no therapeutic value, even though it can have positive effects (“Sport activity reduces the risk of progression and bracing: an observational study of 511 JIS and AIS Risser 0-2 adolescents“).

Conservative or surgical treatment in adults? Two steps of therapy

Is there an alternative treatment to another in adults with scoliosis who suffer from back pain? The answer is no, simply because therapy is made up of several steps. 

It just has been published by the scientific journal Annals of Translational Medicine the editorial comment of Isico “Symptomatic adult spinal deformity: implications for treatment“. A comment to another editorial, namely “Operative Versus Nonoperative Treatment for Adult Symptomatic Lumbar Scoliosiswhich compared the treatment for adults with conservative asymptomatic scoliosis with that for surgical scoliosis.

Let’s start with a premise.

Lumbar scoliosis is particularly relevant for its significant correlation with back pain. There are two main common etiologies for this pattern, degenerative scoliosis and idiopathic. Degenerative curves, also called “de novo” scoliosis, derives from pathological changes at the level of the facet joints and discs in the lumbar spine. Usually, they are not very large but frequently very painful and rapidly progressive. The other type is idiopathic scoliosis appeared during growth that starts its progression in adulthood, usually depending on the size of the curve as previously stated. There is a further type of adult scoliosis called metabolic, which is less frequent.

The most common treatment for scoliosis patients with chronic low back pain, according to current practice, is the surgical one. This has the aim of both preventing progression and improving pain and quality of life. Unfortunately, surgery in such patients is associated with a relevant number of complications, so that it cannot be considered appropriate for every patient. Moreover, some patients don’t want to be operated.

“The study we considered – explains Dr Francesca di Felice, physician of Isico – presents a mixed design, with a randomized and an observational arm. In both arms, conservative treatment was compared to surgery. The general conclusions were driven from the observational arm, since in the randomized one the rate of crossover was dramatically high (64%): this led to similar results for both the approaches in the intent to treat analysis (ITT). For the observational arm, the success of surgery in improving pain and reducing disability was clearly higher than for the conservative approach as supported by the as-treated analysis. We think that this study raises a number of interesting points that should be discussed in the scientific community. The authors tried to apply the best possible design, which is the randomized control trial, but its results were not really informative for the high crossover rate. Hence our comment.”

The ITT is considered more conservative in such cases, and this could be an advantage in case some efficacy is equally demonstrated, but it also underestimates the side effects, and this is a significant shortcoming. We think it’s thus evident that the RCT design cannot be applied to the comparison of surgery and conservative treatment at least in this specific field of spine care. When patients have to face big issues like painful scoliosis, and/or very invasive treatments like fusion for scoliosis, they want to choose their treatment. Some of them want to be operated in case the conservative treatment is not effective, and others are scared of surgery and decide to avoid it. 

Another limitation of the study is that there was no distinction between degenerative and idiopathic scoliosis. We know that the progression rate of the two is different, and also the association with pain. Degenerative scoliosis is more challenging for the conservative treatment, and focusing on this would have been more informative.

Furthermore, the most severe surgical complications for the patient compared to conservative exercise and brace treatment were not considered in the study.

We are convinced that the choice between one treatment or another cannot be an alternative and thus dichotomous – concludes Dr Di Felice – both treatments must be considered as a step of therapy, if conservative treatment is not sufficient, it is necessary to resort to surgery.

 Surgical complications are a big challenge in adult patients with scoliosis, so we cannot consider surgery as the best option for a problem that can affect QoL but is not life-threatening. We strongly believe that surgery can be a good option for very selected and motivated patients, but we need more data about the advantages of a surgery over the conservative treatment, and hopefully a further improvement of the surgical approach. On the other side, the conservative treatment protocol applied in this study doesn’t rely on the Guidelines on the conservative treatment currently available, we need an appropriately conservative approach to be studied, based on the current guidelines and evidence and managed by experts in the field.”

Seas: how it evolves to move forward

Due to the Coronavirus emergency and the consequent restrictive measures, our SEAS courses, foreseen in different countries of the world in the next period, cannot be done: we are ready to reschedule them as soon as possible.
In some cases, however, SEAS has been able to evolve in online mode in order not to stop completely.
After the four-handed course in Moscow when Michele Romano, director of physical therapy in Isico, was connected online from Milan, we were invited to hold a theoretical Webinar in Turkey, a few days ago, on April 22nd.
In both cases it was a success beyond expectations, considering that the Webinar had 600 participants. During the Webinar, Dr Michele Romano explained what SEAS is, the scientific evidence of this type of approach to the treatment of idiopathic scoliosis and how it will evolve after the epidemic.

About Seas Course in Moscow, the lessons were given by our director of physiotherapy, Michele Romano, who linked up with 21 participants in Moscow, together with the course organiser Dr Dimitri Gorkovsky, who is a sports physician and specialist in physical and rehabilitation medicine.

“As the current situation prevented me from going to Moscow in person, as originally planned, we took a last-minute decision to switch from a residential to an online course” Romano explained. “A fundamentally important role in the success of this event was played by Dr Gorkovsky, who, since 2016, has worked with us on the staging of eight previous courses in various Russian cities: Moscow, St. Petersburg and Novosibirsk.”

On all these previous occasions, Dr Gorkovsky flanked Romano, translating from English into Russian.
“Those past experiences certainly helped me this time, as I am now familiar with the topic” he said. “Michele gave practical demonstrations using a dummy, which we watched via Skype, and I then replicated these exercises with volunteers from among the participants. Instead, Michele was able to answer the participants’ questions and clarify their doubts directly, as though he were here with us. The course was excellent, as usual, and the participants were very satisfied with what they learned. This remote modality could certainly represent an important opportunity for the future.”

Teleprevention: a video

If we analyse it, movement, in general, is part of different aspects of our lives: knowledge, therapies, human relationships… And, of course, we are also talking about physical activity: our body in motion! 

More than anything, movement promotes wellbeing, mental as well as physical, and above all, it helps to prevent conditions of the kind our specialists deal with, such as low back pain and neck pain. The more we move, the less susceptible we are to such ailments.

Our director of physiotherapy, Michele Romano, has prepared a video in which he explains how to prevent back pain and presents a series of simple exercises to be done at home.
They take up very little time and you don’t need any equipment to do them: preventive exercises in telehealth mode
Share our exercise programme using the hashtag #isicotelemedicine. 

Take a look at the video!

Bracing works better in Italy

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”.

Telemedicine in response to Covid-19 emergency: the first results

I have appreciated being able to have continuity of treatment and the certainty that I can go on being supported by my doctor and therapist even in an emergency, like the one created by the coronavirus outbreak”. This is one of many anonymous comments collected by ISICO through quality assessment questionnaires that patients are filling in, voluntarily, to give us their personal feedback on our telemedicine service. 

The first results show a very high level of satisfaction among patients (mean overall satisfaction rating 2.8/3). Dozens of them clearly feel reassured by the fact that the telemedicine modality guarantees them continuity of care. As well as considering the modality worth recommending to others (mean satisfaction rating 2.8/3), they also feel that the information they have received is clear and exhaustive (mean satisfaction rating 2.99/3). 

As you know, on March 16th, after 13 days of constant and increasing cancellations due to travel restrictions (50% of bookings), ISICO launched its telemedicine initiative. 

It was clear to us, here at ISICO, that we needed to find a way of guaranteeing our patients ongoing care while at the same time removing the need for them to travel and physically access health facilities, thereby protecting them from possible contact with the virus.

Over the 12 days since the introduction of this new system, we have provided more than 1000 medical consultations or physiotherapy sessions in telemedicine mode, and cut face-to-face interventions to just 0.5% of the total. 

“This is a viable solution allowing us to continue providing services to patients, while eliminating the risk of infection associated with the need (both for patients and healthcare providers) to travel and access health facilities” explains Prof. Stefano Negrini, medical and scientific director of Isico. 

Organizing the service

The ISICO staff worked together, in teleconferences, to identify the tools necessary to conduct examinations remotely, i.e. via Skype or WhatsApp video call. The sensitive data are not recorded on these channels, but only in the internally used and protected file storage.

To be able to conduct examinations in telemedicine mode, we requested the collaboration of parents, sending them tutorials on how to photograph their children in a way that would allow us to do the measurements necessary to evaluate the state of their scoliosis.

We also had to explain to parents how the patient should be positioned in relation to the video camera. “Of course, measurements obtained in this way are slightly less reliable than those taken directly, but the photos/videos we are sent before the actual examination are generally of good quality” Prof. Negrini adds.

Parental support is also essential for delivering rehabilitation in telemedicine mode. “Fortunately, parents are always there in the gym, and so they are familiar with the work we do with their children” says Michele Romano, director of physiotherapy at ISICO. “We therapists have also sent written instructions and tutorials to explain how to perform simple tests of musculoskeletal function, and how to make their own simple measurement tools, which then help us to obtain reliable data. We are able to do, remotely, 70% of what we would normally do at the center”.

Consultations include adapted measurements and evaluations, which are done both “live” and from the photos/videos received. During physiotherapy sessions, new sets of exercises are defined and recorded. In both these settings, interviews and counselling are performed as usual.

It is worth recalling that treatments provided by ISICO are mostly based on home practice. Patients exercise at home 10/20 minutes per day, and individual physiotherapy sessions are provided every 30-90 (deformities) or 7-15 (pain) days.
During the sessions, physiotherapists perform evaluations, update and teach exercises (video recorded by parents), and provide patients with cognitive-behavioural therapy and counselling. An App, synchronised with the individual patient’s file, is used to manage treatment plans, provide exercise programmes and videos, promote compliance (with motivational tools) and encourage contact between patients and physiotherapists.

In conclusion, our early results are extremely positive. The telemedicine approach, which has been well received both by the patients and the professionals involved, has given us a means of providing uninterrupted outpatient services. In the current pandemic, this approach, reducing the need for travel and face-to-face contacts, can offer a viable alternative to closure for many outpatient services.

Telemedicine: the video explaining

Prof. Stefano Negrini, medical director of Isico explains how the examinations and treatments evolve during the Coronavirus epidemic.
Isico maintains its commitment and the trust that patients have given us by putting their health in our hands.

Isico launches Telemedicine: home treatment and care for the duration of the coronavirus emergency

Dear Patients and Families,

The most difficult periods we face in life are the ones when we most need to be courageous and decisive, and look to the future.

We are living through a dramatic time, in which the health of every single one of us must take priority over every other consideration. And at a time like this, we, as a clinical institute, are acutely aware of our mission as doctors, therapists and specialists: a whole team working to support you, our patients. Because you have shown faith in us, by putting your health in our hands.

Over recent weeks, we have tried to keep all our outpatient clinics running, always in full compliance with the different regulations that have, progressively, been issued. Many of our patients in this period have had to go without examinations and treatments. 

Scoliosis, however, is a condition that goes on evolving all the time. Therefore, even in the midst of the present coronavirus emergency, it is crucial to ensure that treatments are not interrupted.

With the dual aim of guaranteeing our patients continuity of care while at the same time taking steps to drastically decrease the risk of infection, on Monday 16 March, we introduced a radically new way of operating. This has been done in order to limit the movements of our staff members, to limit the clinical activities performed in our dozens of centres throughout Italy, and thus to reduce, as far as possible, the risk of the virus being spread during examinations and treatments. However, for us, limiting does not mean not being there for our patients: we are still providing examinations, prescriptions and treatments, but we are adapting our activity to the rigorous restrictions imposed by our country. In recent days we have been working harder than ever, racing to find new approaches and solutions, in order to continue repaying your faith in us.

Isico is now ready to activate a new method for providing examinations and treatments, in all situations in which this is feasible. This approach, called Telemedicine, is a hugely important opportunity for patients. The patients we see are ones whose condition requires or can require

 a long and difficult course of treatment, and this is a way of preventing their hard work and sacrifices from going to waste. This new approach also reflects our determination to do all we can to reduce the burden on our National Health System, which is wrestling with the emergency, and also to do our bit for our country and for the many families facing unexpected economic hardship (we will be offering examinations and treatments at reduced rates). Obviously, these services will remain unchanged in terms of duration, timing and quality.

As one of our physiotherapists, Marta Tavernaro, wrote on the Facebook page aimed at our scoliosis patients: “I am not worried about this approach. We therapists already use it to follow young patients abroad, and for some time now our doctors have been studying an approach that might allow us to reach youngsters the world over. However, this emergency has hit everyone with catastrophic speed, and we have had to work day and night to come up with an adequate solution. Personally, in my 30-year career as a physiotherapist I have never experienced as many emotions, or had so many thoughts running round in my head as I have in recent days. Never before have I found it so hard to advise those who called me asking for advice, in this case on what they should do about their planned examinations and treatments. Now, however, with Isico Telemedicine, we have found the solution. And the fact that we have managed to do this is, believe me, yet another Isico miracle! At last, I have some peace of mind: in addition to being able, as a private citizen, to play my part in tackling this dreadful situation, I am now confident, as a professional, that I can go on giving our young patients the support they need without exposing them to the slightest risk”. 

Should we have been looking for further confirmation of the value of our approach, in recent days the New England Journal of Medicine published an editorial entitled Virtually Perfect? Telemedicine for Covid-19which remarks that”disasters and pandemics pose unique challenges to health care delivery. Though telehealth will not solve them all, it’s well suited for scenarios in which infrastructure remains intact and clinicians are available to see patients”.

Isico has equipped itself to be, until the emergency ends, a digital institute.

Together we can get through this difficult time.

Isico launches a free psychological support service

Recent weeks have seen Italy, and the world, plunged into an emergency that is quite naturally leaving people feeling fearful and anxious. Fear is a normal and useful reaction, because it helps us to prevent, and therefore avoid, danger. Sometimes, however, these emotions become overwhelming and prevent us from seeing things in the right perspective: anxiety can become unmanageable and turn into panic. That is why, in these difficult times, we need to look after our mental health, and not just our physical health.

Isico has launched a psychological support service available not only to its patients and their families, but to anyone in Italy who needs this kind of help.

The service consists of two free Skype sessions aimed at providing users with the tools they need to manage the current situation. Dr Irene Ferrario is a psychologist who already works with our therapeutic team. “To combat the spread of the virus, our government has ordered us to stay at home, allowing us to go out only when strictly necessary” she says. “But ‘doing our bit’ isn’t always easy. Our social contacts have been drastically reduced and the future is suddenly filled with uncertainty: all this naturally makes us feel isolated, lonely and unhappy. The aim of these Skype interviews is to help patients find ways of managing the emotions generated by this situation, and also to provide them with practical advice that might enable them to deal with this enormous upheaval in our daily lives more calmly”.

Online interviews are an easy and convenient way of getting direct help from a professional without having to leave the home. What is more, this method of delivery has no detrimental impact on the usual ethical and care standards. 

The current scientific evidence also shows that psychological support and treatments provided online are just as effective as those provided face to face” Dr Ferrario adds. “In a review of the literature carried out in 2016, which considered data from 15 years of research, more than 100 randomized controlled trials showed online psychological and psychotherapeutic interventions to be effective in treating a very broad spectrum of medical and psychiatric conditions”.