Exemplary Project. DIAPRO MS-APP THE NETHERLANDS April 2018
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1 Exemplary Project DIAPRO MS-APP THE NETHERLANDS April 2018
2 This document was prepared as part of the EU-funded project: ESIF Support in the area of health: building knowledge and capacities for monitoring and implementation, supporting innovation and effectiveness. Study Contract No Author: Milieu Ltd This document was produced under the EU s third Health Programme ( ) in the framework of a service contract with the Consumers, Agriculture, Health and Food Executive Agency (Chafea) acting under the mandate from the European Commission. The content of this document represents the views of the contractor and is its sole responsibility; it can in no way be taken to reflect the views of the European Commission and/or Chafea or any other body of the European Union. The European Commission and/or Chafea do not guarantee the accuracy of the data included in this report, nor do they accept responsibility for any use made by third parties thereof.
3 The Netherlands - DiaPro MS-app: From big data to individual diagnosis, prognosis and provision of information concerning multiple sclerosis General information OP information Timeline Budget Beneficiary/ies Category of intervention: Contact details Project website Thematic block covered Title OP: Priority axis: Investment priority: Specific objective: Start date: End date: Total budget: Co-financing rate: EU Fund: Main beneficiary: Other organisations: OP East Netherlands ERDF Innovation 1B Promoting business investment in R&I, developing links and synergies between enterprises, research and development centres and higher education ( ) 1B-B Increasing the proportion of sales from new products by companies through the promotion of experimental development of new products, including the development and testing of prototypes in SMEs 01/07/ /06/2017 EUR % ERDF Orikami (private company involved in data analysis and production) Drug Target Identification and Development (DTID), Ltd. 64: Research and innovation processes in SMEs (including voucher schemes, process, design, service and social innovation) Name: Organisation: Role in project: address: Bram den Teuling Data Scientist, orikami Project manager bram@orikami.nl T3: ehealth and digital health technologies Project summary Multiple sclerosis (MS) manifests itself in the Netherlands in about one in people, and the first symptoms usually occur between ages 15 and 50. The diagnosis and prognosis of the disease are often difficult to determine and define, as the clinical symptoms and course of MS can vary greatly between patients. In order to address these issues, the DiaPro MS project was set up, aiming to develop a more targeted and individual approach to the disease that would allow for an earlier diagnosis and more accurate prognosis of this complex disease, as well as a better tailored provision of information to the patient. Such an approach would not only improve the overall quality of life of MS patients but also reduce the economic pressure that MS puts on society. A wealth of genetic data and other 'big data' related to MS has become available during the past decades. The first main aim of the project was to integrate all publicly available information into a so-called 'molecular landscape' of MS, which served as the basis for generating the smartphone application DiaPro MS-app. The idea behind the application is to (eventually) combine data from MS patients (genetic data as well as information on biomarkers and possible drug targets) with clinical information - i.e. patients' individual symptoms - in order to support MS specialists in: 1) earlier and better disease diagnosis and prognosis; and 2)in the long term, the best possible treatment(s) in individual MS patients. 1
4 The second main aim of the project was to conduct a pilot study by testing the smartphone app in a small group of MS patients, aiming to receive feedback on the app and further improve its usability as well as to develop a range of tests that can be carried out by the patients themselves, allowing them to register data on their disease progression in a more continuous manner. The pilot study resulted in an application that allows the patients to do a walking test, a cognitive test and a balance test. A FitBit wearable was integrated into the application, which also registers useful data and information on the patients' movements and activity. Finally, the DiaPro MS-app is currently being evaluated in a validation study, involving 60 people, i.e. 30 MS patients and a healthy control group of 30 people. The results of this study are expected in September 2017, but the pilot study already shows promising results. Development and Implementation Initiator/trigger Project objective Target group(s) Project health-related indicators There were various triggers that resulted in the development of this project. Firstly, from a company perspective it was an interesting opportunity, as it allowed the company to combine its knowledge and research in the area of biophysics with data science in the medical sector. It also provided Orikami with the opportunity to collaborate with a new partner who is operating in a different field, i.e. DTID. Finally, the complexity of MS and its considerable variability was considered a challenge that the beneficiaries wanted to address and tackle, as so far similar research and products had not been conducted or developed. The project has three objectives: 1. To be better able to diagnose MS at an earlier stage in the process; 2. To determine the prognosis of the disease more accurately; and 3. To provide the patient with more individual and targeted information and advice, including - in the long term - the best possible treatment for his/ her MS. The project will benefit MS patients as it will allow them to measure and register their symptoms on a more regular basis, which will result in a better diagnosis, prognosis and information provision of the disease and its symptoms. Moreover, as the project combines big data of MS with clinical information on patients individual symptoms, it will in the long term provide MS specialists and neurologists with new evidence and information that will allow to better understanding of the course and progression of the disease. The application will be successful if it is able to facilitate the following two processes: 1. Better interpretation of genetic, biomarker and clinical characteristics of the MS patient, resulting in a better MS diagnosis and prognosis; 2. Provision of more targeted and individual information to the MS patient. Results Expected/attained results, outcomes and potential impacts Success factors & Challenges The results of the pilot study are promising. Patients who were part of the pilot consider the application to be user friendly and easy to handle. Moreover, the MS patients who participated in the pilot were still enthusiastic about the product towards the end of the study and did not show any disinterest in continuing to use the product. The pilot only had one dropout case, as the patient became too ill to keep participating. After 70 days, the patients involved in the pilot study had used the application on 70-80% of the days. The ongoing validation study, which involves a larger group of patients as well as a control group, will provide the beneficiaries with further data and information on the application and its usability and usefulness for MS patients as well as MS specialists and neurologists. The validation study will also allow the project team to conduct statistical analyses of the data acquired. Challenges encountered during the project included problems in relation to resources and administrative matters: people left the project team and therefore, the continuity of support and follow-up was interrupted. It also took longer than expected to get medical ethical approval for the validation study. Another challenge was that only a limited number of patients and neurologists could be involved in the project due to budget restrictions. With regards to the success factors, an important element was the direct involvement of patients and neurologists in the development and optimisation of the application. Moreover, the app was promoted during hackathon events, which resulted in 2
5 quite a lot of media attention and useful feedback that was important for further development of the product. Potential for replication The application has great potential for replication in other countries. MS specialists and neurologists from other regions of the Netherlands as well as Belgium and the United Kingdom have already expressed an interest in the app. Based on these conversations, the timing, content and product format seem to be adequate for other regions and countries too. Wider context Relevance of the project to the objective of the relevant thematic block Relevance of the project objective to the specific objective of the OP Relevance of the project towards reducing health inequalities Relevance of the project towards the reform of health systems Relevance of the project objective to the national context and policy goals Relevance of the project objective to health policy goals at EU level The project is relevant for thematic block 3 on e-health is it demonstrates how mobile applications can be used for the diagnosis, prognosis and collection of information and data of people suffering from a specific disease. In the context of MS, the use of a mobile app allows for a more continuous registration of clinical symptoms, which has so far not been possible in the Netherlands (normally, patients only see their neurologist - on average - once a year). The project concerns the development of a new product, but it does not directly contribute to the increase of sales as a result of it, as the development of application is still in the testing phase. However, if the product becomes successful and interest has already been shown by stakeholders from the Netherlands and abroad to continue and further expand the work this could indeed result in an increasing sales revenue. The project does not have a specific objective that contributes to reducing health inequalities. The project does not directly contribute towards the reform of health systems. However, it does show the potential of mhealth for both patients and medical professionals, which could result in changing health systems in the long term. No-health specific CSRs in The project contributes to the development of new tools for healthcare. 3
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