3 publicaciones etiquetados con "Clinical trials"

Introduction​

The future of dermatology has arrived thanks to Legit.Health's revolutionary application of the PASI system: APASI (Automatic Psoriasis Area and Severity Index). Using computer vision algorithms, the researchers have created a tool that processes smartphone images and automatically translates them into the domain of the PASI.

It is widely known that objective, reliable, and precise outcome measures are key to evidence-based medicine. When considering psoriasis, the PASI has the best measurement properties and is the most recommended for clinical trials. That is why we automated the PASI to help patients and doctors achieve better health outcomes.

The origins of the PASI​

This scoring system for psoriasis was first published in a paper by T. Fredericksson and U. Pettersson in 1978, where they explored the validity of a new treatment for the disease.

Their formula for assessing the severity of the condition would go on to become the gold standard for dermatologists around the globe and is still widely used to this day.

In order to calculate the PASI, the sum of the severity of these three main changes was multiplied with the numerical value of the areas involved and with the various percentages of the four body areas. These values were then added in order to obtain the PASI.

The shortfalls of the pen-and-paper PASI​

The main goal of PASI is to provide a tool to record data precisely and consistently for routine evaluations and clinical studies. However, it carries a set of problems and limitations.

We found substantial variation [in the results] between experienced and inexperienced physicians using PASI

In other words, there is a high inter-observer variability, that is most pronounced when compared between experienced and inexperienced practitioners.

Aside from the inter-observer variation, many physicians have reported that filling up the paper sheet is too tedious and time-consuming and that they don't really use it on a day-to-day basis.

Digital calculators: A half-baked solution to the problem​

With the advent of basic computation, several digitalized versions of the PASI scoring system were developed, in an attempt to reduce the time wasted in calculations. These online calculators tackle, although inefficiently, just one of the issues the traditional PASI has. While the formula is calculated automatically, the doctor still has to fill in the value for each parameter.

This not only still requires the time and attention of the physician, but does nothing to address the multiple issues of lack of objectivity and reproducibility within the PASI system.

¿Cómo sabemos si un sistema de puntuación es bueno?​

Cuando se trata de evaluaciones dermatológicas, la efectividad de un sistema de puntuación es primordial. Pero, ¿qué es exactamente lo que hace que un sistema de puntuación sea fiable y útil? A través del consenso científico, se han identificado varios factores clave que contribuyen a la robustez de estas escalas. Vamos a profundizar en los elementos cruciales:

• Facilidad de uso: Este factor considera si el sistema puede aplicarse sin esfuerzo dentro de las limitaciones de tiempo y recursos financieros. Que un sistema sea fácil de usar es crucial para su adopción generalizada en entornos clínicos.
• Sensibilidad al cambio: Un sistema de puntuación efectivo debe ser capaz de detectar cambios clínicamente significativos a lo largo del tiempo. Esta sensibilidad asegura que cualquier progreso o deterioro en la condición de un paciente se captura con precisión.
• Fiabilidad interobservador: Esto se refiere a la consistencia de los resultados cuando diferentes observadores utilizan el sistema de puntuación. Una alta fiabilidad interobservador significa que diferentes dermatólogos llegarán a conclusiones similares, mejorando la credibilidad del sistema.
• Variabilidad intraobservador: Esto analiza la consistencia de los resultados cuando el mismo observador utiliza el sistema de puntuación varias veces. Una baja variabilidad intraobservador indica que el sistema proporciona resultados similares todas las veces que un mismo dermatólogo evalúe un mismo caso.
• Interpretabilidad: Un sistema de puntuación práctico debería proporcionar interpretaciones cualitativas significativas de sus puntuaciones, como categorizar la gravedad de una condición como leve, moderada o severa.

Estos criterios no solo aseguran la efectividad del sistema de puntuación sino también su aplicabilidad y fiabilidad en diversos escenarios clínicos.

Adaptado de "Methods and definitions to rate the quality of outcome measures". Schmitt, J., Langan, S., Deckert, S., Svensson, A., von Kobyletzki, L., Thomas, K., & Spuls, P. (2013). Assessment of clinical signs of atopic dermatitis: A systematic review and recommendation. Journal of Allergy and Clinical Immunology, 132(6), 1337--1347. doi:10.1016/j.jaci.2013.07.008.

Six ways in which APASI is better​

Legit.Health is the revolutionary Clinical Data and Communication tool for Next-generation dermatologists that triples the empowerment of patients.

After 12 months using Legit.Health, in which we analysed the applicability of the tool at our hospital, we have drawn conclusions that help to propose a new care paradigm in the follow-up of psoriasis.

The purpose of the deep learning algorithms is to relieve doctors from the tedious manual calculation of scoring systems and allow the practice of more objective evidence-based dermatology while speeding up the pathology reporting process and increasing patients' autonomy and control.

Legit.Health's algorithms automatically grade lesions just by looking at smartphone images and small patient-reported outcome measures (PROMs). In other words: the tool will automatically fill in most of the dermatology scoring systems, such as PASI, SCORAD, UAS, GAGS, and many more.

Esto significa que la nueva versión de este sistema de puntuación extrae datos de manera precisa y consistente, tanto durante evaluaciones rutinarias como en investigación clínica. La mejora se puede ver en la siguiente tabla, que compara las métricas de rendimiento de la forma más común de utilizar los sistemas de puntuación:

	Papel y lápiz	Digital	Automático (IA)
Auto-supervisión	-	-	Realiza diagnóstico
Facilidad de uso	≈ 600 segundos	≈ 420 segundos	≈ 23 segundos
Sensibilidad al cambio	0 a 4	0 a 4	0 a 100
Variabilidad interobservador	Media (20%)	Media (20%)	La más baja (8%)
Variabilidad intraobservador	Alta	Alta	Cero

Gracias a los algoritmos de aprendizaje profundo, Legit.Health libera a los médicos de la tediosa tarea de calcular manualmente los sistemas de puntuación y permite la práctica de una dermatología basada en evidencia más objetiva. Además, al utilizar algoritmos para medir la sequedad, la liquenificación, el eritema, el exudado, el edema y muchos más signos, la herramienta puede calcular signos visuales de manera más fiable y consistente.

1. Easier to use and faster than any other existing method​

While an experienced physician might take six to seven minutes to completely fill in and calculate the PASI score of a patient, an inexperienced one will need ten minutes. Meanwhile, Legit.Health's algorithm only takes 23 seconds to get the final score, including capturing the image.

This is key both from a time management perspective, allowing the doctors better use their time with the patient, and from a clinical perspective. The fact that many physicians won't fill in any scoring system for considering the process too tedious and time-consuming and would rather make a gut estimate of the severity of the disease is incompatible with the modern idea of practising evidence-based medicine.

2. APASI assists the doctor in the diagnosis of the disease​

The algorithm developed by Legit.Health isn't limited to simply measuring the severity, like the PASI does. It can also help assess whether or not the condition is actually psoriasis. The APASI has been trained using the input of top dermatologists to distinguish between hundreds of conditions, including most types of psoriasis.

This means that APASI will distinguish between several types of psoriasis and assist the doctor in the disease assessment process, not only making it quicker by providing relevant information but improving the rate of correct diagnosis by 23%

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3. APASI can detect small changes in the evolution of the pathology​

Legit.Health's tool analyzes the pathologies using a validated scoring system that has both the lowest MID (Minimal important Difference) and is sensible to the lowest LDC (Lowest Detectable Change), which means the algorithm analyzes every image with more precision and attention to detail than any human observer would.

In clinical trials, quantification of the disease is critical to measure the efficacy of an investigational treatment by comparing the severity of disease before therapy to that measured after treatment.

Furthermore, it has a higher validity and reliability while maintaining comparable clinimetric properties, thanks to the intrinsic functioning of computer vision algorithms.

4. Greatly reduces inter-observer variability​

Our data indicate that even experienced investigators had difficulty with PASI in rating the area of involvement […], especially among patients with more severe psoriasis.

The experimental results show that APASI outperforms the baseline methods when it comes to inter-observer variability, achieving a mean absolute percentage of error of just 13%, way below the usual 20% that can be observed in the classical application of the traditional scoring systems.

5. Zero intra-observer variability​

The algorithmic nature of the APASI eliminates entirely, and without question, the intra-observer variability, as every reading is reliably consistent.

This allows the doctor to not rely on his memory when assessing the severity of the psoriasis, so they can focus on the analysis of the contextual information. In this sense, the more objective data reduces considerably the risk of misdiagnosing, providing a more objective, accurate, and precise way of tracing the development of the disease.

To judge a treatment effect, the variation in rating a patient from time to time should be low

This becomes especially important in clinical trials, where reducing this kind of variability is key to gathering the precise data required in this kind of study.

6. More accessible and easier-to-read data​

Last but not least, Legit.Health's interface provides access to all the relevant information about the patient in an easy-to-read manner.

Every data derived from the APASI is clearly displayed on the screen, showing the severity of the affection and the different factors considered by the algorithm when analyzing the image and their scores.

The app also provides a handy graff that shows the evolution of the disease across time and makes following the healing process and the effectiveness of the treatment really easy.

Do you want to see the clinical AI technology in action?

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In conclusion​

The revolutionary and innovative APASI represents the future of dermatology. We are giving doctors access to the best tool for the diagnosis of psoriasis and allowing them to practice evidence-based medicine and improve the communication between doctor and patient.

Thanks to Legit.Health, doctors across the globe can improve their correct diagnosis rate by 23% and make treatment easier to follow for the patient by making them active participants in their own recovery.

There is no denying that the use of algorithms that estimate the severity of the disease represents a bright future for the practice of dermatology and that will, without doubt, help advance the field.

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This free 23-day trial of Legit.Health gives clinics and hospitals a hands-on look at how to drive increased adherence and improve patient outcomes, as well as improving efficiency and overall quality of life.

Healthcare provider Ribera Salud and Legit.Health started working together in one of the group's hospitals, the Torrejón Hospital, to implement the revolutionary algorithmic technology that, 2 years later, has shown excellent results.

In 2020, the healthcare provider Ribera Salud and Legit.Health started working together in one of the group's hospitals, the Torrejón Hospital, to implement the revolutionary algorithmic technology that, 2 years later, has shown excellent results thanks to the amazing job done by the doctors.

The pandemic could be a blessing in disguise, as it forced the teams to truly push the possibilities of remote care to new heights. In this particular case, the team at Torrejón Hospital needed to follow up on the patient's treatment but could not ensure all of them could go to the medical centre due to COVID-19.

Under these circumstances at hand, Legit.Health was the perfect tool for the job.

Video Summary​

Watch Dr Elena Sanchez Largo's presentation: Artificial Intelligence for Remote Monitoring of Patients With Skin Conditions, where she lays out an overview of how the hospital uses Legit.Health's solution.

Next to Dr Sanchez-Largo, the co-founder of Legit.Health, Taig Mac Carthy, explains some of the key components of the solution, such as the severity measure feature, which automates the filling of scoring systems like PASI or SCORAD.

It is pretty easy to see how a telematic tool like Legit.Health can help to monitor patients remotely. But, how does it manage not to add to the doctor's workload by making them have to worry about yet another system? Let's find out.

First Step: Patient registration​

Implementing a new system into an established workflow is a dreaded task for most people. After all, that workflow has been honed and perfected along with years of adjustment and modifications, and including a new element to it can feel like throwing a wrench into a well-oiled machine.

Thankfully, the process of onboarding new patients is both easy and contained in time, as it only needs to happen once.

Once the doctors at Torrejón Hospital had access to their Legit.Health account (a process that barely takes two minutes) they just needed to, as a part of a visit, ask for the Patient's Name, Surname, Email, or Telephone, and input their Pathology information.

Onboarding​

The onboarding process only takes part once for each patient.

This process takes no more than a minute, and it only needs to happen once, but if you want to avoid it completely it is possible to avoid this step altogether thanks to Legit.Health's Dermatology API.

In Torrejón Hospital's case, the patients confirmed their account and logged in with their password on the spot, and were instructed by the doctor to check their email or phones for alerts asking them to take pictures for the monitoring.

In total, both doctors and patients have spent around 5 minutes combined to set up this process. And although at Torrejón Hospital the medical team chose to take this process into their own hands, at other centres they leave the patient registration step in the hands of their non-medical teams.

Second step: Follow up​

Once the system had been set up, each Torrejón Hospital patient began a continuous use loop, where the follow-up and monitorization process gets simplified by the algorithm into a single decision by the doctors.

Each time a patient uploads a picture, either because the doctor had set an upload pattern for them on their last visit or because they felt like their condition has changed significantly, the algorithm processes the information.

After analysing the image, if the algorithms detect an increase in severity or in the suspicion of malignancy or pre-malignancy, it will flag the picture as urgent and show it to the doctor first.

Continuous use​

Brief description of what Doctors and Patients do when using Legit.Health

The doctor then can, at any time, review all the pictures sent to them by their patients, being able to set up a face-to-face consultation if they think is necessary or simply send a message to the patients with indications about the treatment and the upload pattern.

This not only takes a minimal amount of work for the doctor for each patient, but in fact increases the efficiency significantly.

The true heroes of the story​

The implementation of new technology is most challenging for doctors, as they are already very busy with the clinical workload. Luckily, the great dermatologists at Torrejón are very innovative professionals, who aim at improving their daily practices by finding better ways to care for patients.

The main conclusion here is that technology comes second, and clinical talent comes first. If the medical team is talented and capable, any solution can flourish. And that is precisely what happened when Hospital U. of Torrejón implemented Legit.Health.

The best results we can show you of how this project has worked, are the words of some of the doctors involved:

Dr Elena Sánchez-Largo​

The use of applications for telematic follow-up allows the flow of information between doctor and patient without the need for face-to-face consultations, adjusting it to a more real time and allowing changes in the therapeutic attitude more quickly and effectively.

Dr Elena Sánchez-Largo has put Legit.Health to work with her Psoriasis patients at Torrejón Hospital, achieving great results.

She reports that 27% of her patients benefited from an early adjustment to their treatment, all thanks to the improvement in the communication between doctor and patient.

You can follow Elena Sánchez-Largo on twitter

Dr Marta Andreu​

This telematic follow-up prevented school absences in paediatric patients, work absences in adults, and allowed the follow-up of patients in quarantine due to COVID-19 or with diseases that make it difficult to travel. Both patients and their dermatologists showed a high degree of satisfaction with the use of the app, with 100% of patients interested in continuing to use the tool.

Dr. Marta Andreu puts into perspective the use of the app at Torrejón hospital, saying it was used in patients of Psoriasis, Atopic Dermatitis, Urticaria, Acne, and Hidradenitis Suppurativa. She highlights the good reception of the app from the patients and how its use improved the satisfaction they had with the medical centre.

You can find Dr. Marta Andreu on LinkedIn.

In future posts, we hope to highlight also the work and talent of their colleagues, such as Dr. Leticia Calzado, Dr. Marta Andreu, Dra. Marta Ruano or Dr. Javier Alcántara, to name a few. Truly highly innovative healthcare professionals who are exploring the best ways of caring for their patients and improving health systems.

Get access now​

This free 23-day trial of Legit.Health gives clinics and hospitals a hands-on look at how to drive increased adherence and improve patient outcomes, as well as improving efficiency and overall quality of life.

Introduction​

In recent years, society as a whole has started to get used to the inevitability of a fully digital world embedding itself in all aspects of life, including healthcare.

And although there are many benefits the applied practice of telemedicine brings, there are also challenges to overcome before we can start to reap the benefits of this novel way of understanding healthcare.

Dermatologists highlight the usefulness of images in remote monitoring of chronic pathologies. That is why the tool is still in use today in our care activity, and we continue to explore new uses and improvements to it in the future.

Telemedicine is a reality, not a prediction​

Digital disconnection is no longer a possibility for the average person. To this day and age, where every home has an internet connection and every pocket is laced with a smartphone, trying to deny the power the global net holds over our daily lives is as ridiculous as impractical.

Of course, the healthcare world is no different in that regard. Those who try to resist this wave of modernization are quickly being left behind or are being forced to adapt. It is common for concepts like telemedicine to be treated in future tense, but the COVID-19 pandemic has shown us that the time of predictions is over.

It is time to face the challenges that this new form of healthcare brings to us.

The past of remote care​

One of the first practical usages of telemedicine happened in the late 1950s, in the state of Nebraska, where a state hospital and a psychiatric institution implemented a closed-circuit television link in order to help to monitor the conditions of patients remotely.

Although technology did rapidly advance in the following decades, its application to the remote care of patients never got through to be majorly used. Thus far, the most notorious advancement consists in a telephonic consultation, despite being widely considered an insufficient measure by both physicians and patients.

Today, the urge of using telemedicine is rather a reality than a remote possibility. The pandemic of 2020 rapidly changed the perception and necessities of many, forcing the healthcare community to prioritize efficiency and implement all the tools at their disposal.

What does the future look like?​

Even though it is foolish to try to predict what future technologies will be developed in the next decade, we can learn from the most recent advancements to make an educated guess on the scientifical progress that will shape the future of healthcare.

An example can be the expansion of portable wirelessly accessible sensors, built into smartphones, smartwatches and other wearable devices, that allow doctors to collect data about their patients in real life and with minimal interference on their day-to-day life.

Another very promising prospect is Artificial Intelligence. Projects based on this technology have shown great results in the last couple of years in areas as diverse as oncology, radiotherapy, neurology, and dermatology.

One shining example of the use of Artificial Intelligence is Legit.Health, the revolutionary Clinical Data and Communication tool for Next-generation dermatologists that applies clinically validated algorithms and computer vision technology to enhance their medical practice.

The purpose of the deep learning algorithms is to relieve doctors from the tedious manual calculation of scoring systems and to allow the practice of a more objective evidence-based dermatology while speeding up the pathology reporting process and increasing patients' autonomy and control.

The 5 challenges of modern telemedicine​

Financing​

As commonly happens when suggesting to introduce a new technology or infrastructure, detractors rise money as an issue. However, considering only the potential costs of overhauling the medical system to make it more telematic is rather reductive unless the potential savings and profits are taken into account.

Balancing the economic costs and benefits of telemedicine will be without any doubt one of the biggest challenges to overcome, and the companies that offer services in this field need to keep that in mind. That's why Legit.Health keeps its pricing flexible and its technological requirements simple, so that any medical centre or institution can afford the small investment required.

Regulations​

Another big challenge to overcome before adopting a fully telemetric system has to do with laws and regulations. It varies from country to country, but anywhere you go in the world, the implementation of medical devices is heavily regulated.

Additionally, if those devices manage patient information, laws like GDPR come into place to guarantee the security and integrity of the data. That's why any attempt of leaning into telemedicine requires addressing these issues.

Legit.Health not only has the European CE marking, but is a tool that is fully compliant with the GDPR as well as all other European standards, taking some of the burden and the hard work associated with keeping these matters in check. In other words, your work will be mostly done for you when the time for an audit comes.

Adoption​

All the fancy technology in the world is equally useful or wasteful if those who are meant to use it do not know how to or do not want to adopt it. In this case, the challenge is twofold, as doctors and patients must come to terms with the idea of including these new technologies in the dynamics that have been ingrained in our collective mind for centuries.

Not only we need to convince patients that they can effectively communicate with their doctors via computers and smartphones, but we also need to help doctors adapt their usual routines to this novel systems.

This is why, Legit.Health has been developed with ease of use in mind. After being taken by the patient, the picture is analysed by the clinically validated algorithm and its results are sent to the doctor, who benefits from the consistency of the data generated by this process and greatly facilitates the work of monitoring rashes and disease development.

Technology​

Technology has been the focus of telemedicine for a long time. However, telemedicine is really about the services and not about the uniqueness of the latest technology. An approach based on services and positive health outcomes means that no matter how much technology changes, the medical centre will have a system in place to implement it.

Legit.Health enables medical centres to merge technology and service into one easy-to-use package, offering both a plethora of tools for the medical practice and multiple options to provide their patients with the services they need to feel cared for.

Evidence​

In the medical world, good ideas amount to nothing if they aren't backed by solid clinical evidence. This is true for procedures, drugs, medical devices and, of course, general concepts or services such as telemedicine.

Gathering scientific evidence might be the most difficult challenge telemedicine has to overcome before it can succeed. Every system, application, medical device or technology put in place to make this change possible must be thoroughly tested before it's implemented into a real-life setting.

Legit.Health participates in a myriad of clinical trials that pit algorithmic technology and application design against real medical scenarios in several European medical centres. As a company, we highly value our presence on medical journals, and helping to advance the field of dermatology is one of our main purposes.

In conclusion​

Although the road ahead is long and tortuous, the healthcare community as a whole has already begun to take the first steps towards a future where telemedicine is a reality.

Thanks to technological advances by companies such as Legit.Health and initiatives by medical service providers such as DKV, to name a few, both patients and doctors are becoming more accustomed to the reality of remote medicine.

Get access now​

This free 23-day trial of Legit.Health gives clinics and hospitals a hands-on look at how to drive increased adherence and improve patient outcomes, as well as improving efficiency and overall quality of life.