Thank you very much. Here are my disclosures, but most of all, I'm not American, and so I hope you will forgive my language mistakes, and I hope you will forgive my usage of PRM instead of PM&R. And we all have this burden on our shoulders, the concept that in PRM there is no evidence, so I would like to discuss a little bit about this point. This is an overview of my lecture. I will introduce you to evidence-based medicine, physical rehabilitation medicine in EBM, implementation of EBM in PRM, and then some final solutions and conclusions. And I would like to start with Charles II, King of England and Scotland. He had a stroke and was obviously treated by the best physicians of his kingdom, and so he had 16 ounces of bloodletting, not allowed to sleep, making him sitting, glass caps on the shoulders, shoulder scarification for five ounces more of bloodletting, emetics and laxatives at high dosage with repeated clisters, shaven and stick needles in the head, white hot coterie. Luckily, he never wake up again. That was the so-called official medicine at that time. So we have to question a little bit about this concept of official medicine. Why official medicine is better than alternative, complementary medicine? So I will speak to you to Dr. Lind, it has nothing to do with chocolate, and he had to do with scurvy. And you know that in the beginning of the exploration, sea exploration, there was this huge problem of scurvy, and Dr. Lind was a physician of the Royal College, and the Royal College told him to use the sulfuric acid. While the admiralty was paid by the admiralty, the admiralty said to use vinegar to treat scurvy. So he was in a challenge, the one who paid and the one who make his job worthwhile. He did the first controlled study in the literature ever published, and he had these 12 patients, and he gave the different treatments of the time, and I think you can guess what was the best treatment. But it took to him 40 years, since he was a very young doctor, he came back to England, 40 years before even accepting and publishing his results, because it was not accepted by the Royal College. So just to say, another problem of science is not only producing the results, but also have these results accepted. So this is the first controlled study in the story. Here in the States, you for sure know very well the history of thalidomide, and this drug went to an incredible boost of the FDA, because of the damages that this drug was creating. And if you look in a perspective of all these things, you see that what characterized official medicine was learning. Learning from our own mistakes, learning from what we were doing, and trying to create a methodology to develop better understanding of what we are doing. Dr. Spock, Dr. Spock is not the one of Star Wars, he's the one of a very well-known pediatrician, and he was the first one who said that you don't have to beat your kids to make them grow up well. And so it was quite an important educational topic, and in his book he wrote that you should make infants sleep on their stomach. And now, and if you remember, 20, 30 years ago, and you enter in a world, all the little kids were lying on their stomach, because that was suggested by a very important author, a very well-known author, pediatrician. But then it came, the first randomized controlled trials, then it came the first meta-analysis clearly showing that sleeping on the stomach increases four times the chance of having sudden infant death syndrome. So this tells a lot about the importance of the important authors. You can be an important author, but you can make mistakes, and that can be proven only through regular studies. So there is a methodological pathway in all this, and in fact evidence-based medicine, this is my point, is only the last step of this pathway. Evidence-based medicine has been defined as the explicit, conscientious, and judicious use of the current best evidence in making decisions about the care of individual patients. And practice must include the best research evidence, the patient values, and your expertise, your own expertise. And the combination of the three can give the best, most appropriate treatment for your patient. One of the problems that we are facing today is the continuous, incredible increase and growth of research. And nowadays in PubMed you can find, I didn't look in the last year, but a couple of years ago was 800,000 papers per year. How can you keep the pace with this incredibly increasing number of research? And this growth made the need to have some kind of a selection. And one way that has been proposed by the evidence-based medicine is the best methodology allow us to understand which are the best paper on which we can best rely. And this is the very well-known pyramids of evidence, even if we will see later that has been changed a little bit. But this is still at the base of evidence-based medicine. So my first point is that ABM is the last methodological achievement in the young history of medicine. And we cannot avoid to look at it. We can criticize, we can discuss, we can do whatever we want, but evidence-based medicine is there and is there to help us, not against us as someone like to say. And I also want to introduce Cochrane. Cochrane is not so well-known in the States like it is well-known in Europe. Cochrane, Archibald Cochrane you've seen on the extreme right, died 30 years ago and 25 years ago has been founded in his name the so-called Cochrane Collaboration. What's called Cochrane Collaboration now is only Cochrane. The vision of Cochrane is a world of improved health where decisions about health and health care are informed by high-quality, relevant, and up-to-date synthesized research evidence. So we should work basing ourselves on the best evidence. And the work of Cochrane is to produce systematic reviews and meta-analysis in all the fields of medicine to understand what are at this moment the best treatments. So in all medicine, not only in rehabilitation. And you see on the right the new edition of the pyramids in which the top has been cut and it becomes a lens to look at all the literature produced. One of the characteristics of Cochrane is that there is no conflict. No conflict at all, no sponsorships, it's based only on a voluntary board. There are 35,000 researchers all over the world that work voluntarily in this group. Why is Cochrane important? An example, this comes from a very good friend of mine, a physiotherapist. He had two very nice blonde girls with long hair, and they had a problem. They had pediculosis. And can you imagine these two nice girls with pediculosis, like the girls that we have seen upstairs, the cheerleaders? And can you imagine the drama? They tried everything, and they were at the point of shaving them completely, and the drama in the family. And at that point, I used to discuss with this friend about ABM and Cochrane, and so he said he had an idea. Okay, let's look at what Cochrane says. And he found this review, and he used that treatment, and he solved the problem. He didn't have to shave his daughters. So this is just a little example. But this guy now is author of two Cochrane reviews. This guy has totally converted to evidence-based medicine. And this is the problem of license, but think of your own problems. Think of your own patients. Think of where you can find the most reliable information, not the most up-to-date. You have to be careful about that. For sure you will not find anything about genetic therapy. It's too early to have a randomized control trial, to have a systematic review. It takes time. So you don't find the most up-to-date, but you find the most reliable, the one that you cannot avoid. So this is the website of the Cochrane Library. In the Cochrane Library, you can find all the information you are searching for at their best update today. This is the website of Cochrane, and this is the website of Cochrane Rehabilitation that we'll introduce to you later. Very easy to use. You just wrote www.cochranerehabilitation.org or cochrane.org or rehabilitation.cochrane.org. So very easy. So Cochrane today is the actual gold standard for a good EBM approach. Let's move to physical rehabilitation medicine and EBM. You all know this biopsychosocial model produced by the World Health Organization that gives us a description of the human being in a way, and the classical medical specialties focus on a specific area. They focus on the health condition, and they focus on the body function and structure. But this is not physical rehabilitation medicine. Physical rehabilitation medicine, this comes from the White Book of Physical Rehabilitation Medicine in Europe that will be published in February. That is an interesting book that you could all look at, an interesting reference. And we focus on body function and structure, but we focus mainly on activities while having input from all the rest of this graph and looking for the best participation of our patients. So we have a different focus from the other specialties. And in that book, in the White Book, for example, it is represented this aspect when compared to a classical specialty. We are not disease-oriented. We are person- and functioning-oriented. Our diagnosis and prognosis is not only medical, but we have also the functional, and it's so important in our specialty. Our treatments usually are not unimodal. They are multimodal. Morbidities, we usually have to deal with patients with multiple morbidities, not a single morbidity, and we look at the multiple morbidities. This is also our own interest. And the professional approach is rarely individual. It is usually multi-professional in a team. All these challenge the EBM approach. All these challenge our research approach. And so what are the problems? There are many problems. I cannot list these problems all together now in this presentation. But just look at the setting. We have outpatient, inpatient, primary, secondary, tertiary. We cover all the settings, and not like other specialties that are usually focused on one specific setting. We have the problem of functional diagnosis, but it's not so well-defined as it is well-defined, the medical diagnosis. You have the ICD code, and you have the medical diagnosis. Why the functional diagnosis is something different, not so well-defined. When you look at the design, I found this list of 32 possible biases in research, and I tried to look at them in terms of physical rehabilitation medicine. At least 13 of these are very difficult in our specialty because of how our specialty deals with behaviors. Our specialty deals with human relationships. And we have to face all these problems, and this creates inherent biases in most of our researchers. It's not so difficult to research around the drug. I would say it's not so difficult to research around an injection, around a robotic application, but when you try to look at the overall picture, not only at the robotic application inside your rehabilitation field, you are facing so many faces in this, so many problems. In randomized control trials, we have always problem of blinding. This is a problem most of the time in allocation concealment. I invite you to look at this paper published in the Annals of Medicine by the leader of our methodological committee in cochlear rehabilitation, Antti Malmivara, that proposed the benchmarking control trials. The benchmarking control trials are a very interesting solution for healthcare system, but also for multiple interventions. It's just comparing two situations, not comparing two treatments, and is an observational trial, but can avoid some of the problems of the randomized control trials that we are facing. We have problem of meters. The rehabilitation process is based on team, multi-professional, interdisciplinary, on the competencies of people and how many papers we find in which is not well defined what was the competence of the therapist. If you don't know what the therapist was competent in, beyond being a physical therapist, you don't know. Then the other point is the convincement. Convincement of the patient and convincement of the therapist of what he is doing. How do we measure that? We know very well if you give a treatment on one side with a not convinced therapist, even if the treatment is bad, is good, is the best one, if the therapist is not convinced, you will have the worst result when compared to the convinced therapist with the bad treatment. And we don't measure that. We should have a solution for that. We are working as Cochrane Rehabilitation on this topic because we need to have solutions to produce a good research, understandable research. And there are technical factors. I would like to focus mainly on the usual therapy factor. The black box. We have done a systematic review. We are going to publish this systematic review. It has to be submitted in a few days. We looked at 86 papers about lower limb stroke, published in one decade, and were all randomized controlled trials. But we didn't look at the treatment. We looked at the usual therapy. Because all these papers related to a treatment added to usual therapy. What is usual therapy? Do you know what is usual therapy? And we found 20 different treatments in the usual therapy group. And treatment ranged from one treatment to seven treatments. The mode was free. We had one time three papers of three different groups with the same treatment, but it was gait and gait training. That was the similar treatment. Then we had two papers of two different groups with the same treatment, and then all the rest where they were all different one from the other. So 80 papers with usual treatment, and the description of the usual treatment was different. So just imagine to use your robot above a usual therapy. And this usual therapy includes seven treatments, but you are doing only one treatment. You use your robot above one treatment. Do you think the result will be the same? Again, what are we studying now? What are we trying to understand if we don't face this problem? And so the usual, the black box is the black hole of our research. And then let's look at the multi-modal approach. I put myself in that slide. Put myself in front of those different ingredients. Like our treatments, we have different ingredients. And we try to do a sucker tort. I will be for sure on the right. Same ingredients, totally different results. This is the expertise. This is the ability to combine the treatment and to achieve the best results. This is so inherent to our specialty. When you put some physiotherapy together with some occupational therapy, with some speech therapy, with neuropsychological approach, and you deal with a team, the team is speaking or is not speaking between them. Are they collaborating or not? Are they fighting or not? And the result will be a different sucker tort. And those are our patients. And this is something that I don't know if I will be able to see this solution before going to pension, but we have to work on that. We cannot avoid to work on that. Otherwise, we don't understand what we are doing. I will look at the ethical committee approval as the last point because that is quite interesting also. So we have big methodological problems that we have to face, and we need a place where to face these kind of problems. Then the state of research. I wanted to publish these results, and I found there was a paper published just a couple of years ago in the American Archives of Physical Rehabilitation Medicine showing exactly the same data. So I will show mine now. I looked at rehabilitation. This was a paper in the European Journal some years ago that showed the dramatic increase of research that we are facing in physical rehabilitation medicine, doubling in 10 years all over the world, in all countries. So I told you that there is this increase of papers in general in MEDLINE, but if you look at the relative increase of physical rehabilitation medicine, of rehabilitation, compared to the rehabilitation mesh term, compared to the growth of the papers published in general, the growth of rehabilitation mesh term is much higher than the growth of... The line you see in the middle is the relative calculation when compared to the growth above. And this is the growth of all studies and the growth of randomized controlled trials, systematic reviews, and meta-analysis. Relatively, in percentage, when compared to all the other studies, randomized controlled trials and systematic reviews and meta-analysis are growing much more than what is growing in general rehabilitation. That is, the percentage of randomized controlled trials is almost 10% among all the studies published in rehabilitation nowadays. Quite incredible. All this data comes from the data, the production of the National Library of Medicine of the U.S. So each paper that is published in MEDLINE has its own mesh terms and is defined as a randomized controlled trial or not directly by the National Library of Medicine. So it doesn't come from me. It's just extracting the data from Medline. And so I looked at the rehabilitation when compared to physiotherapy modalities. And they are growing at the same rate, almost. But drug therapy is not growing as much. The number of randomized controlled trials remains almost the same. Yeah, these are randomized controlled trials. But what is rehabilitation? Rehabilitation mesh includes a lot of things. So I tried to figure out what could be more interesting for us, neurological rehabilitation and exercise therapy. These are really our work. And if you look at this graph again, the direction is that. We are growing. We are producing more and more randomized controlled trial. We are producing more and more systematic reviews. And why we are so challenged about the evidence? I think this is an answer that we are trying to give. We are trying to face the challenge of evidence. We are trying to produce more and more randomized controlled trials. They are with little numbers. When you compare the numbers of drug therapy, you have 5,000 patients per arm. In our randomized controlled trials, we had 25, 30 patients per arm. But if you are able to show the difference, if the sensibility of the study is enough to show the difference, it's not important to have 5,000. You don't need 5,000 patients. In fact, the problem of drug therapy is to show such a little difference between the different drugs. But they need 5,000 patients. We don't need 5,000 patients. We are able to show, and we have a good power analysis, showing that what we have published with 30 patients is enough. And this is also why I don't like at all finding everywhere these are provisional results waiting for bigger numbers. If you have done a good power analysis, those are not provisional results. Those are results. And you must say that. But we always think that we need big numbers. That's not true. Depends of what you are looking for. And in rehabilitation, we are looking for big changes, not yet too little changes. We are not yet at that stage. It will take some 30, 40 years before we will be able to look at the little changes. Because now we are really looking at the big picture, not the little things. And now I want to introduce you a little bit to the concept of knowledge translation before reaching the end of the presentation. We all know that there is a big gap between what we know and what we do. This is common knowledge. And this is really the big problem of evidence-based medicine. We know that something works. For example, when I started my job many, many years ago, I was very well aware that putting a person in bed for low back pain, as been demonstrated, was not correct. But I was fighting for at least 10 years of my profession against big professors from big universities stating that for low back pain, you have to go to bed. And I think we all faced that period some years ago. And because before you are able to apply in the everyday life something that has been proven by research, it takes a year. I told you 40 years for the poor Dr. Lind with his results about scurvy. And for us, it's shown that it takes 10 years, usually. And in a country like Italy where we don't speak English, it's 20 years. What is knowledge translation? It is a dynamic interactive process that includes the synthesis, dissemination, exchange, and ethically sound application of knowledge to improve health, provide effective health services and products, and strengthen the health care system. So you have the knowledge. You need to package the knowledge and push the knowledge to the users, to the end users. This is something that now is also very well known by Cochrane. And Cochrane is working a lot to change and to improve its ability to make the evidence they produce used in the everyday world by clinicians. And they have found at least four different audiences, consumers and public, practitioners, policymakers, and health care managers, researchers, and research founders. These four groups need different languages. Need different concepts. If you give a Cochrane review to a politician, what will do a politician with a Cochrane review? If you give a Cochrane, have you ever read a Cochrane review? A Cochrane review is 70, 80 pages of data, very well structured with all the information you need. But also, a clinician will never read a Cochrane review. It takes too much time. You need a little peel of information in front of your patient. You need a little. So now Cochrane is really working in trying to produce this, to do this knowledge translation. It is something on which we are working all together. I am in the KT advisory board of Cochrane. And we are trying to make it useful to everybody in the best way. And obviously, I look at it in the terms of rehabilitation. I am trying to influence all that structure to make it work in a way that is useful for rehabilitation. These are into that knowledge translation. We will discuss a little bit more in the next hour after this talk. We will have the Cochrane rehabilitation session in this same room. So we can discuss a little bit more about that. And let's arrive to Cochrane rehabilitation. What is Cochrane rehabilitation? Cochrane is organized in groups. And you have the review groups. And the review groups produce the evidence. You have the methods groups. There are 15 groups only focusing on methods to produce the best evidence. And they are incredible. There are incredible people there. And then there are the centers. So there is the US center. There is the Italian center. Those are geographically located to make Cochrane work into the single reality. And then there are the fields and networks that deals with things that cannot be dealt well by the review groups. Just to give you an example, there are today 56 Cochrane review groups. We looked at those. And we found more than 20 reviews of interest for PRM in these four groups, back and neck, bone joint and muscle trauma, musculoskeletal, and stroke. But when we looked at least one review of PRM interest, we found 28 out of 56 groups had at least one review. And this is one problem of our specialty. We don't have really a container for all these reviews, a place where you can find all the reviews. And that's why we looked at creating a field, a field that is transversal to all the specialties, to collect and put together all the reviews of interest for rehabilitation, but also to make in a way that rehabilitation is represented in Cochrane. Rehabilitation was not represented. In the place where the best evidence is produced, there was not the voice of rehabilitation. This is also important. Because the methodology, if you look at some comparison, this is a classical comparison in my field. I deal with scoliosis and spinal disorders. And you usually find the papers, the randomized control trials comparing surgery to rehabilitation. And you find the best surgeon compared to usual therapy. And we know very well what usual therapy is. In this case, usual therapy is the simple physiotherapist that a spinal surgeon can have around him. How can you compare? And then usually you find that there are no big differences. That's astonishing. And that's quite a lot. Anyway, this should be faced, should be considered in the methodological approach to these studies. And we need the rehabilitation professionals inside the group producing reviews. And this is another job that we are trying to support in the next future. And what is a field? A field is a bridge. It's a bridge between two sides of the rivers. On one side, you have the stakeholders. And we are the stakeholders. On another side, you have Cochrane. And you need the communication between the two. You create the communication between the two. On one side, you have to give Cochrane to the stakeholders. That means spreading the knowledge. On the other side, you have to give rehabilitation to Cochrane and making a way that Cochrane produces something that is significant for us and not something that is not significant. And this is part of the job. So our vision is that all rehabilitation professionals can apply evidence-based clinical practice and that decision makers will be able to take decisions according to the best and most appropriate evidence. And we do it in two ways. On one way is to collect all the evidence and make it known to the world of rehabilitation. And in another way, we want to improve the methods for evidence synthesis related to rehabilitation. We are working on the methodology. And this is so crucial for us. We are volunteers. We have some funds, not so much. And we organized ourselves. But we are not a society. We are an organization. And this is how we are trying to function. And we organize ourselves quite in a complex way. This is the group of people that are in the executive committee. And we are from all over the world. And that is very important. We have an advisory board. And it was quite impressive. And Walter Frontera was there when we had the first meeting in the ISPRM in Buenos Aires, putting together the precedents of ISPO, ISPRM, WCPT, WFNR, WFOT. They are all so much challenged by evidence. When we told them that we need to work on evidence through cognitive rehabilitation, they just came. We have 12 journals in our advisory board. Just to tell you how much is felt important all this, we didn't know at start. But we realized while working on this. And we have contributors and partners from all over the world. And I would like to have much more people from the US. So I hope you will soon join us. This is our website I have already shown to you. In our website, you can find evidence. And in evidence, we are putting the database of all the Cochrane Reviews of Interest for Rehabilitation. At this point, we have 100. But those comes only from the first six months of 2017. We are almost ready to publish all those from 2015 until now. Because the selection process is quite demanding. And we are working in a very careful way with two people checking the reviews, finding agreement, and eventually discussing. So we are quite careful in what to include and what not. In these years, we had some publication. And two of them you can find in the American Journal. And the collaboration with the American Journal is very strong. We have a newsletter. So if you want, you just put your mail there. And you can receive in a newsletter the last information. We have the blogshops. The blogshops is a typical production of Cochrane. And in the blogshops, you have a very appeal of what has been published in the last reviews. And we are producing. Our aim is to send out a blogshop once a week. And we have the reviews once a week. So it's not so difficult. It's just a question of making it work. And since January, we started once a week. But we are not yet set completely. So you can also subscribe to this. These are published in the White Book. And these are in the Twitter. So just linking and, again, going on the site, you can link and have all this information. And then we have calls. What are the calls? If you want to help us, we just spread around the call. We need people to help in the review selection. We need people to help in this, on that. And everyone can help if they just want to give some time to support this effort that is important for all of us. So just giving your email, we can let you receive a call. And then you can participate in what you are able to do, not anything else. Then we have the methodological committee. The methodological committee, as I told you, is crucial for us. We started working on the problems of EBM in rehabilitation. And we published a first paper about a survey we made. And we will have probably a special issue on methodological problem in the European Journal in 2019, coming from a workshop of two days that will be run before the ISPRM. So if there is someone here that want to help in that effort, just let us know. And you can help us on that. And we will have Cochrane Corners. We had a discussion yesterday with Walter Frontier how to organize these Cochrane Corners in the single journals, how to make without superposition between the different journals around the world. And we are trying to be very fair in this process. And I hope after the summer, we will be able to start the first Cochrane Corners in the main journals. We are working on e-book. The e-book has been supported with 50,000 euros by the European Physical and Rehabilitation Medicine bodies that are the Union, the Society, and the Academy of Rehabilitation Medicine. And the e-book will collect all these reviews but digest it. The aim is to produce summaries for the different audiences so that a student enter there and look at the student summaries of the reviews. A clinician enter there, a politician, an administrator enter there and found very little slogans with one single statement stressing the results of that review. So to make it understandable and usable for the different audiences. Then we have lectures and workshops and other initiatives. We are working quite a lot, I must say. And we will have the time to discuss about that. So let's arrive to the conclusion. What can we do to face all these challenges? What can we do about this concept that PRM has low evidence? Cochrane rehabilitation can be an answer. But we are producing so much research, so much randomized control trials, so many randomized control trials, so many systematic reviews. So perhaps it's the time to think out of the box. I would like to introduce you to this very important paper published in the British Medical Journal in, I don't find the date, 2003, a piece of history. The parachute systematic review, their aim was to determine if parachutes were effective. So they made a systematic, very well-done research of the literature. And they didn't find any randomized control trial. So the conclusion is that parachute could be useful, but we don't know. What does this mean? What does this mean? This means that not everything can be proven. Can you imagine in a patient with a stroke not to make him walk? To produce a randomized control trial to check if gait is a good approach for stroke patients? Is that possible? It's like a parachute trial. How many things we are doing every day that are like a parachute trial? We have so much evidence there. But the point is that we are challenged from the view that randomized control trials are the only way to produce evidence. But it's not true. It's very well parachutely proven. So we have to perform randomized control trial about who makes him walk, how to make him walk, but not about making him walk. And this is a challenge that probably we will try to face in the next phase. We are not yet ready with cochlear rehabilitation, but with ISPRM and with other societies, at least of the evidence that should not be proven, but is already there in rehabilitation. And that is something that should really be considered when we are challenged with evidence. And we need to find out what should not be proven. And you just look at what an ethical committee would not approve in your study. And ethical committees are already telling us what is parachute, because they would not approve it. And then there is another point. Is everything provable only through randomized control trials? No. No. So the other point is that probably we need different pyramids, not only one pyramid. We do not have to be challenged by the only one pyramid that is valid, is the most valid. For sure it's the most valid, but the best is enemy of the good. So we need to define a priori what are the pyramids of evidence, and in which situation is correct to use the classical pyramid, and which other situation we need to use a little less high pyramid with different top. And this is the challenge that I want to propose to Cochrane. Cochrane should look, not only a randomized control trial, should look at the top of the pyramid. But the top of the pyramid is different in different fields, in different situations. But that should be defined a priori, not a posteriori. And this is because methodologically we cannot arrive after and say this is the best. No, we cannot. We should define in which situation this is the best, in which other situation that is the best. And then we will produce the best evidence according to the different pyramids. And this is another challenge that we will have to face, and we will face as Cochrane Rehabilitation in the next years. It will take some years, but OK, we have time. So take home messages. EBM is the last mythological achievement of medicine. Cochrane is the actual, I don't know what happened there, gold standard for a good EBM approach. PRM has specific challenges for EBM that must be faced. PRM research methodological problems requires better understanding. PRM is comparatively producing a lot of good research. When evidence is known, a knowledge translation effort is required, and Cochrane Rehabilitation is the KT organization for PRM. This is what we are trying to do. And PRM needs new out-of-the-box thinking about the evidence that we have and how to generate future better evidence. And I hope that after this lecture, we will realize a little bit that this is a challenge, but perhaps more than a big rock on our shoulders is a pebble in the shoe of PRM, this concept of evidence. Thank you very much. Thank you.

evidence-based medicine

Cochrane collaboration

physical rehabilitation medicine

research selection

knowledge translation

collaboration

Cochrane Library

expanding evidence base