New generation of Personal Health Systems enabling quality health data and information gathering and use Nicos Maglaveras Professor & Director Lab of Medical Informatics Aristotle University Thessaloniki, GREECE EMAIL.
Download ReportTranscript New generation of Personal Health Systems enabling quality health data and information gathering and use Nicos Maglaveras Professor & Director Lab of Medical Informatics Aristotle University Thessaloniki, GREECE EMAIL.
New generation of Personal Health Systems enabling quality health data and information gathering and use Nicos Maglaveras Professor & Director Lab of Medical Informatics Aristotle University Thessaloniki, GREECE EMAIL : [email protected] Some background….. • Health delivery is becoming more preventive, continuous, and personalized • A large scale of biomedical data and information are becoming available for use in health delivery • Biomedical data are produced by diverse sources and technologies • Medical decision support is directly related with data quality, medical evidence and intelligent semantics extraction and integration Main Features of Personal Health Systems (PHS) • Personal health systems aim in the monitoring, intelligent interaction between physicians and patients, implementation of multiparametric information analysis, providing coaching and intervention possibilities, enable medical decision support, and personalize health services delivery. • The main layers as it concerns information a PHS are the data layer, the information layer, the knowledge engineering layer and the output of information processing and analysis. • In all the above mentioned layers, the primary concern is the quality both in data and information, thus increasing the need for filtering out noise and artifacts from wherever they originate. • PHS lead to new R&D pathways as it concerns biomedical information processing and management, as well as new pathways in designing new intelligent medical CDSS enabling timely medical interventions and quality health care delivery. PHS – TELEHEALTH - AAL • Telehealth is expected to become a reality in the near future • Today we are developing the third generation of telemedicine systems, implementing closed loop approaches such as e.g. in the HEARTCYCLE project • Use of the above mentioned systems / modules is expected to be used in the multimorbid patients management arena and the AAL and healthy ageing arena, involving users more and more • In the end PHS, PGS, VPH, access platforms, are expected to be integrated and work in an interoperable and reconfigurable way Major challenges in PHS data & information gathering • Embedding intelligence and medical knowledge in personal health systems • Multi-parametric modeling for clinical decision support • Contextualization of healthcare services • Interoperability across personal health systems and the clinical IT infrastructure (EHR, PHR, PGS) • Patient and healthcare professionals’ acceptance • Evaluation aspects of coordinated care (CC) • Data: – are generated in huge volumes, fast & continuously – vary in nature and complexity – vary in structure; it can be even unpredictable! (=> ad-hoc solutions required) → “Big data” characteristics: Volume, Velocity and Versatility (3V) • “Big data” management: – Cloud-based approaches have been proposed – But still: • efficient distribution of data and workload to support massive parallel processing is a challenge • data-intensive processing over a distributed network of computer machines is required 6 • To generate “Value” out data, i.e. mastering the process to derive insight from the data; requires: – capturing data, aligning data from different sources, transforming data for analytical processing, modelling data and, finally, understanding the output as well as visualizing and sharing the results • Beyond “big data” management: – Scalable Data Analytics (SDA) to empower organizations in extracting knowledge from their data and support decision making – Deployment of flexible and open platform architectures for data streaming, federated storage solutions and above all robust and scalable data analytics 7 • Decentralization: Highly distributed across the healthcare organization • Wide range: Span from clinical information systems to research information systems and personal health systems • Technical heterogeneity, with differences in terms of: – schematic and semantic information representation and – data access (from legacy systems to well-defined / standardbased communication interfaces) • Autonomy: Typically operate independently, but their linkage is required 8 • “Big data” technologies are considered the cornerstone of “Personalized Medicine” • Medical information systems are “big data” producers, especially when seen in an integrated fashion: – e.g. Electronic Health Record + Personal Health Record + Patient Monitoring System + Genetic Profiling (e.g. Next Generation Sequencers) • Exploiting value from data is a key quality procedure for healthcare organizations: – May help healthcare professionals in decision making and patient treatment 9 Data complexity scale evolution Support wide-scale epidemiological studies by managing and exploiting the wealth of sensor data Support the management and exploitation of data in the context of wide-scale health-related studies (e.g. concerning lifestyle) acquired via opportunistic sensing by devices like smartphones Contribute in individualized care through scalable data analytics 11 • Within the clinical environment a wide variety of Information Systems operate • The dominant Information System is the Electronic Medical Record • All actions and resources within the clinical environment are expected to be captured and annotated electronically • The necessity for continuity of health/medical records brings to the scene a key challenge: interoperability! 12 • A wide range of data sources is available, capable to facilitate medication safety: spontaneous reporting systems, EHRs, patient reports, scientific literature • Key challenges: – effectively explore large volumes of heterogeneous data – capturing the dynamic features of the obtained drug safety signals 13 More Americans die from medical errors than from car accidents, breast cancer, or AIDS annually, 44,00098,000 deaths/year Medication errors result in at least 1 death per day and 1.5 million people injured per year Estimated US annual cost of drug-related morbidity and mortality is nearly $17 billion Preventable adverse drug events cost the healthcare system $2.5 billion annually Institute of Medicine, Preventing Medication Errors, 2006 14 KOHN LT, CORRIGAN J, DONALDSON MS. To err is human building a safer health system. Washington, D.C.: National Academy Press; 2000. The PSIP (http://www.psip-project.eu/) approach: Identification of Adverse Drug Events (ADEs) via data and semantic mining applied on large volumes of patient data (EHRs), so as to obtain a better knowledge of the prevalence of ADEs and of their characteristics per Medical Department, Hospital, Region, and Country Development of concepts, methods and knowledgebased modules to provide contextualized Clinical Decision Support System (CDSS) functions for ADEs prevention 16 Identification of ADEs requires large volumes of quality-controlled, longitudinal data to be analyzed, e.g., millions of patient records Drug safety signals (typically expressed in the form of rules) have a dynamic nature, i.e. their importance (in terms of statistical significance) varies according to local settings (e.g. a specific hospital department/clinic) and time aspects Knowledge discovery has to be implemented as a continuous process Decision support has to be provided in real-time: Performance is an issue! 17 The “big data” challenge 18 V. Koutkias, V. Kilintzis, G. Stalidis, K. Lazou, J. Niès, L. Durand-Texte, P. McNair, R. Beuscart and N. Maglaveras, “Knowledge Engineering for Adverse Drug Event Prevention: On the Design and Development of a Uniform, Contextualized and Sustainable Knowledge-based Framework”, Journal of Biomedical Informatics, vol. 45, no. 3, 2012, pp. 495-506. 19 30000 25000 # classifications 20000 15000 10000 5000 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Response time (seconds) Scatter plot of the response time (ms) and request size (89,340 classifications) Histogram of the CDSS response time (89,340 classifications) 20 Wider spectrum of data exploration for ADE identification More accurate identification & better understanding of ADEs → Performance issues will occur at a larger scale: Cloud or Grid computing necessary! 21 • Research Information Systems in biomedicine have been recognized as a major source of new knowledge • Typical examples involve data registries obtained through specialized studies following application-specific protocols • Large-scale studies require huge volumes of data to be available and analyzed: – data reuse is an option for acquiring the necessary magnitude of samples 22 • The aim: – Revealing evidence among factors contributing to disease understanding/prognosis/evolution • Challenges: – Coping with heterogeneous data models – The need for semantic integration of data – The need for effective inference mechanisms – Overcoming performance issues – Reproducibility of the results obtained 23 Epidemiologica l data (e.g. lifestyle, marital status, sexual habits, smoking habits, etc.) Clinical data (e.g. clinical tests, health status) Genetic data (e.g. viral type, variant, load, personal and family genotype alterations) Data Assembly For: Hypothesis testing Statistical evaluation Conclusions Goal: Identify new markers of risk, diagnosis and prognosis 24 An integrated environment that: • virtually unifies multiple patient records • facilitates the construction of study groups “on demand” • enables association studies combining phenotypic and genotypic data • automates the process of evaluating medical hypotheses 25 Gynecology Clinic B Medical Format: B data Level of Detail: B Format: B Level of detail: B Medical Data Gynecology Clinic A Medical data Format: A Level of detail: A Medical Data Format: A Level of Detail: A A I SS ST Medical Data Format: C Medical data Level of Detail: C Format: C Level of detail: C Gynecology Clinic C 26 Hypothesis: Combination of certain types of p53, GSTT1 gene polymorphisms and HPV infection increases risk of developing low-grade squamous intraepithelial lesions. Access ASSIST for more data 100 Gynecology Clinics join ASSIST mutually allowing access to patient data: 1. Data differ in degree of detail 2. Use different examinations 3. Have different ranges for normal values Medical Researcher X Gynecology Clinic A ASSIST Local Records: Available p53 and GSTT1 tests for 35 patients Group 1 -> 20 Group 2 -> 15 Gynecology Clinic B Gyn. Clinic C ASSIST: 220 Cases Group 1: 100 cases Group 2: 120 cases 27 Encoding AUTH Charite Un. of Ghent 0: Normal Inflammation Hyperplasia Metaplasia Carnification Hyperkeratosis PAPI PAPII 0: normal 1: reactive changes 1: CIN1, ASCUS, LSIL, AGUS PAPIII PAPIIID LSIL 2: ASCUS 3: LSIL (CIN1 - koilocytosis mild dysplasia) 7: AGC-NOS 2 2: ASC-H, CIN2, CIN3, Ca in situ, AIS PAPIVa PAPIVb HSIL 5: HSIL (CIN2 - CIN3 - CIS moderate & severe dysplasia) 8: AGC-Favours neoplasia 4: ASC-H 9: AIS 3 3: Invasive cancer PAPV 6: squamous cell carcinoma 10: Adenocarcinoma 0 1 28 Clinic 1 Clinic N HPV Test +/- HPV Test +/- Pap Test Class 1/2/3/4 Pap Test Class 1/2/3/4 MTHFR +/- MTHFR N/A Colposcopy Normal/LCIN/ HCIN Diagnosis CIN 1/2/3, Ca ASSIST Virtual Repository Unification HPV Test +/- Pap Test WNL, LCIN, HCIN, Ca Diagnosis Diagnosis CIN 1/2/3, Ca Colposcopy MTHFR HPV test Clinic 2 Colposcopy Normal/LCIN/ HCIN Test Pap test MTHFR Colposcopy + - Normal WNL LCIN HCIN Cancer CIN2 CIN3 + - +/N/A CIN 1/2/3, Ca Class1 Class2 CIN1 Class3 Class4 Relation <isMeasured> Relation <subsumes> 29 RULE 1: IF There is a Difference between any two diagnostic test results (Colposcopy, Cytology, Biopsy) >= 2 , THEN The greater index should be used as <severity index> IF all test results are present and the difference between the derived <severity index> and two test results is >=2, then the validity of the derived <severity index> is LOW IF all test results are present and the difference between the derived <severity index> and 1 only test result is >=2 then the validity of the derived <severity index> is MEDIUM IF at least one test result is missing ... 30 31 for Heart Diseases The data engineering perspective The knowledge engineering perspective for Breast Cancer for Cervical Cancer for Colon Cancer 32 Third generation telemonitoring driven PHS • Example case: A pervasive health care system, providing home telemonitoring, surveillance, and educational services to chronic disease patients • Healthcare professionals monitor the patients’ status, based on their regular interaction with the system, and accordingly regulate them through medical interventions • Persistent need for effectively managing and interpreting the large volume of multi-parametric biomedical data collected during the patient sessions / interactions with the system → Efficient information extraction and monitoring mechanisms are required, capable of timely identifying cases where urgent attention is necessary PHS and Tele-monitoring of chronic disease patients issues • Big data are needed for Population Health Management • It is currently difficult to collect large data sets in telehealth home monitoring – Example from the HeartCycle experience • The clinical trials process as well as the modeling based CDSS, and Coordinated Care Why do we need large data sets in coordinated care? • The growth in health expenditures is driven by multiple factors. One critical factor is the rising incidence of chronic diseases, which account for 75% of the cost of medical care. • Chronic patients have higher rates of unnecessary hospital admissions and take many medications to manage their conditions. • Traditional fee-for-service payment models that pay for treatment transactions are ill-suited for serving patients that require close monitoring and treatment tweaking and must be managed in a coordinated fashion. • The traditional providers of chronic disease management, primary care physicians, only touch patients intermittently and rely on patients themselves to comply with care plans and lifestyle recommendations. Why do we need large data sets in coordinated care? • Need for coordinated care – Patients with complex chronic diseases and multiple comorbidities may see on average 11 different doctors a year, creating major challenges for communication, information sharing, reconciliation of care plans and patient follow-up – Another key driver of high health care expenditures is waste. Studies found that roughly 30 percent of health care spending is wasted due to unnecessary or poor quality care and a general lack of coordination between providers. – New incentives are required to increase accountability and foster a continuous improvement culture focused on longitudinal patient outcomes. – In addition, all participants in the health care system – patients, doctors, hospitals, health systems, long-term and post-acute care providers, insurers and government agencies – need to have usable information available to make informed decisions. The HEARTCYCLE APPROACH • HeartCycle developed a personalised disease management care system, integrating care at home with professional care in the hospital. • The approach follows a closed-loop disease management concept that consists of two loops. An inner home-based loop directly interacts with the patient in his daily life, giving feedback, motivation, and tailored help. An outer loop involves medical professionals, maintaining a personalised care plan for optimal therapy. • The HeartCycle project aims to improve the quality of care for coronary heart disease and heart failure patients by developing systems for monitoring their condition at home and involving them in the daily management of their disease. • One of the main goals is to motivate patients to adhere to treatment regimes and adopt beneficial lifestyles, with the expectation that survivability of heart disease is improved and the overall cost of care is reduced. The HEARTCYCLE Professional & User Loops HEARTCYCLE CHF Monitoring and Intervention Functionalities CHF Management System Innovations • #1: Medication Titration • #2: Diuretic Management • #3: Decision Support Analysis (Patient & Professional) • #4: Education & Coaching for Patient Self-Management • #5: Health Maintenance Motivation: feedback on measures and trends, what they mean and what to do about them Health-Care Provider Secondary Loop Analysis Intelligent, integrated, multimeasure (time & type) personalised analysis Education: on healthy lifestyle, reasons for treatments, self management Patient / Carer Primary Loop 70% of Care Decisions Communication System ‘Monitor’ Guided Exercise Innovation • #1: Independence & Compliance • #2: Safety & Confidence • #3: Improved Treatment Delivery & Closer Follow-up Overall HEARTCYCLE Assessment System HEARTCYCLE Assessment Use Cases (AUC) - Innovations • #1: Novel Sensors to Enhance Patient Assessment in the Home Environment • #2: New Information Processing for Integration & Interpretation of Sensor & Patient Data • #3: Improved Decision Support to Maintain Patient Closer to Their Ideal Personal Haemodynamic Profile Novel Sensors • For Assessing – Congestion • Bio-Impedance Monitor (BIM) – Cardiac Output / Function • Multi-Sensor (Sensatron) – Arrhythmia • Sensatron • Bed-Sensor Heart Sounds Impedance • Observational Studies – Incident Events - Longer-Term Observations – Congestion Resolution • Randomized Trials – Clinical Calibration – Haemodynamic Interventions Photoplethysmography GEx – Product Overview Monitoring Service Platform; targeted to patients with CAD providing real-time guidance while exercising, as well as support and motivation while following an exercise plan. 46 GEx – System Components Use Development pending* Shirt (6 different sizes for males and females) to attach sensors and keep them in skin contact Biocompatibility testing for sensation and irritation according to ISO standard Clothing+ Image sensor (with a cradle) records vital signs and exercise related signals CE certification & CE certification as medical device CSEM Patients portable device, including a mobile phone PDA mobile phone for patient interaction; performs sensor data processing, provides feedback to patient during exercise Continua Certification & CE certification as medical device UPM Motivation & Education content Strategy and content to change lifestyle Patients station main interface between the patient and the GEx system; Gateway between the Portable Station and the Professional System and is used as motivational and educational platform Continua Certification & CE certification as medical device UPM Continua Certification & CE certification as medical device TSB/ITACA Component Portable Station Patient Station Professional System Professional System for interaction with medical professionals. Based on clientserver architecture, medical professionals are able to access to the central server using a standard web browser Integrated 47 System Integrated System integration with main server that stores and processes recorded data Exploiter** NHS Heart Manual TSB *Refers to additional development issues required in order for the system to be marketed. **The GEx system will be commercially exploited through subcontracting an external manufacturer under license. GEx – Competitive Positioning Classical Polar’s belt integrated into an Adidas shirt and bra The competitive advantage of the GEx system is that it is tailored specifically to patients with CAD and their needs The BioHarness BT belt by Zephyr 48 Sensatron – Product Overview Around 10 million people in the EU and 5.7 million people in US with HF. There is an unmet need of the cardiologists to be able to frequently monitor haemodynamics in order to safely titrate medication and to effectively target doses Solution Sensatron is an on-body-unit that measures clinical haemodynamic parameters with the aim to be used in home based telehealth scenarios by patients with CHF M A R K E T Targeting the home telemonitoring (HTM) market with focus on systems for non-invasive haemodynamic monitoring BedSensor – Product Overview Ballistocardiography (BCG) based system for non-obtrusive monitoring during sleep that can be easily used at homes sensitive 8-channel foil sensor embedded in bed mattress Adresses the need for cost-effective and . reliable solutions for the diagnosis and follow-up of sleep disorders Magnetometer – Product Overview non-contact monitoring of cardiorespiratory activity; respiration and pulse rate One-Channel Magnetometer applied to chair back-rest (a) measurement sensor sewn coil and flexible electronic part (b) male volunteer wearing a shirt including the sensor 51 cECG– Product Overview non-contact monitoring of cardiac related signals on the body surface without the necessity to undress the user Early stage prototype of a capacitive ECG measurement system (left); the according block diagram (right) Capacitive electrodes integrated into the driver seat of a Ford S-Max 52 Modeling Approaches on Adherence and Complications of Chronic Cardiac Patients in HEARTCYCLE Perspectives And Challenges Based On Continuous Data Gathering And Personal Health Systems PHS and chronic patients • In the scope of PHS data analysis, two basic pillars that may support medical decision, especially in complex or multimorbid chronic patients, are: – Assessment of the person’s response to treatment, including complications, which links directly to the needs for care plan updates by the health professional. – Assessment of adherence to treatment, which reflects the patient’s responsibility in following the therapy as agreed and prescribed by the professional. Main concepts • Medication effectiveness • actual change of vital signs as a result of medication treatment, with respect to the expected change • Medication compliance • patient’s behaviour, as regards the extent to which the prescribed medicines are taken as agreed with the medical professional Assessment of Compliance – Why? • Costs and treatment inefficiency • Barrier to treatment optimisation • 'less forgiving' drugs that, when missed, may lead to an adverse event (e.g. withdrawal symptoms) or disease exacerbation. Compliance Prediction Approaches • Known factors (self-efficacy, depression, health literacy, medication knowledge) in patients with specific profiles (e.g. elderly patients with chronic diseases) – Predictors of medication adherence may use machine learning • Assessment of ability – Drug Regimen Unassisted Grading Scale (DRUGS). The DRUGS tool uses a performance-based measurement to assess the individual’s ability to identify, access, and determine the dosage and timing of their medications. Assessment of Compliance • Direct questioning “Did you take your medication?” – unreliable – judgmental • Questioning – through patient or caregiver interview using open-ended, non-threatening and non-judgmental questions. • Prescription refill records and pill counts – overestimate true adherence rates. – Temporal information ? • Other devices – Digital pill – still in its infancy. Adherence and vital signs • A time series of vital sign values of a patient is expected, after a transitional period due to treatment change, to statistically converge, unless specific causal factors occur in that instance, which might include an acute medical condition, a period of non-adherence, etc.. • Patterns of deviation from the steady state values can be quantify with data driven approaches • This is advantageous due to the existence of vital sign recording in various setups Treatment effect population-based medical evidence • Amplitude of effect • Time scale • What are the factors potentially causing a temporal variation? Example Acute illness Bad diet ? ? Increase salt Withdraw diuretics worsening HF AFib Example: for a patient, we notice that she has: HR •Increased BP •Increased weight What are the possible reasons? Increase weight BP symptoms Clinical Data Protocols Test1 HF & HTN patients The difference between MD-MG days in cycle1 relates to incompliance effect SBP-DBP-HR lying supine, standing, sitting, exercise task preparing The difference between MD-MG days in cycle2 relates to relates to deviations under medication Test 1 - What differs in HF • Morning between day differences vs • Afternoon between day differences • Morning deviation due to medication omission • -relate to salt • -activity? Test 1 - What differs in HTN • Standing/sitting differs due to medication omission • Also due to salt Classifying medication effect & compliance o Single features and pairs of features were tested via linear classifiers with leave-one-out cross-validation o The classification of the incompliance detection seems better in HS o In HTN, the standing to sitting differences (*diff) appear important for classification o In HF, systolic pressure seems more important in LS and diastolic pressure more important in HS Clinical Data protocols Test2 HF & HTN patients In Normal diet • Reference day • Medication given same morning • Medication omitted for 48hrs, and taken after the two cycles of measurements SBP-DBP-HR Medication & Activities • how vitals change with activity & medication in HF 155 med taken med omitted 150 145 Medication omission mean 140 135 130 Among activities 125 120 115 SBP-semiR SBP-su SBP-Leg SBP-st SBP-si SBP-nit SBP s6 25 med taken med omitted 20 15 10 mean 5 0 -5 -10 -15 -20 -25 SBP-semiR SBP-suSBP-LegSBP-st SBP-si SBP-nit SBP s6 DBP-semiR DBP-suDBP-LegDBP-st DBP-si DBP-nitDBP s6 HR-semiRHR-suHR-Leg HR-st HR-si HR-nit HR s6 Constructing Personal models of vital signs • daily vital sign data may vary due to medication, activity, time of the day, lifestyle and diet, as well as other reasons related to health, stress or challenges of life. • non-linear mixed effect modeling (NLME) SBP=f(salt,time,medication,activity) • each parameter is the sum of a fixed and a random effect, which expresses personal variations per patient The model Low salt SBP High salt SBP Med*+ 0.4975 0.3006 Time*+ 0.5104 -0.1739 Activity* 1.8415 1.3527 Ref 0.8676 0.9290 Ref bias -0.2041 -0.1511 Correlation 0.5333 0.4455 Y(i)= beta(1)*sign(time-24h)*time from last med+ beta(2)*time of day+ beta(3)*activity index+ • * the random effects in LS beta(4)*mean value+ • + the random effects in HS beta(5)*(mean-thres); thres=140 for SBP Model results • Low salt SBP 12 20 High salt SBP 10 15 8 10 6 4 5 2 0 0 -2 -5 -4 -10 -6 -15 0 2 4 6 8 10 -8 12 0 2 4 6 8 10 12 SBP, Low Salt 150 real axis model 140 130 120 A subject in low salt 110 100 90 start bedstand1sit1stand2Ex start bedstand1sit1stand2Ex start bedstand1sit1stand2Ex start bedstand1sit1stand2Ex In black: model In red: real Test model with the other datasets • We need to generalise descriptions • Patient Problems and – Disease – Diet – Medication – Personal baseline values – Recordings • Time • Activity • Value challenges Missing values Daily Variation Different profiles, comorbidities, medication dosages How to encode different activities? From controlled experiments to continuous home data • Extending these methods to an uncontrolled PHS case would be extremely exciting – for actually understanding patient’s health condition in real life, including medication effect, compliance, worsening – for guiding patients in achieving health goals – for retrospective data repurposing: the discovery of new patterns and knowledge based on longitudinal continuous physiological data From controlled experiments to continuous home data • New challenges, including: – How can large scale annotated data be requested and acquired – How can the various daily life conditions be mapped to unambiguous and quantitatively processable factors, • Use contextual information , activity, place, lifestyle and out of regular events, medication, stress, symptoms, diet – How can these factors be combined to a model that may help interpret data, and guide patient/health professional Steady properties Cloud Cloud Storage Storage of of PHS PHS data data For example in IndivoX Treatment plans and schedules Activity, e.g. 1 value per min … … Day y Modifiable health parameters Patient Day x • Personal Health Systems and Continuous Data Activity HRV, e.g. 1Hz HRV BP, e.g. 1 value per min BP Diet, as reported Diet Stress, as reported Stress Assuming a basic local processing Sleep, e.g. 1/30 hypnogram Event/Symptom, as reported How much data? In one day/one subject • HR: 86400 samples • BR: 86400 samples • Act: 1440 samples • SBP/DBP: 1440x2 samples • Hypn: 2880 samples 180000 samples per person per day (not to mention context information) In more intensive recordings… • Heart activity monitored by electrocardiography (ECG), I KHz – -> 86.4 million readings a day per patient. – -> heart rate and respiration rate, 86,400 readings a day per patient. • Impedance between each of the three ECG leads attached to the patient’s chest – chest wall movement to assess breathing rates – ->5.4 million data points a day per patient. Some HEARTCYCLE Conclusions • The overall HEARTCYCLE CHF and Gex telemonitoring system has produced the reference data set in its trial phase • AUC are currently used, with new sensors and intelligent modules so as to permit the production of big data coming from PHS in cardiology and other chronic disease domains • The overall high level architecture of the HEARTCYCLE assessment system is defined • The closed-loop system is realised and tested for performance optimisation and assessment of its performance in clinical environment • A third generation of telemonitoring systems is launched and currently in use Coordinated Care, Big Data and the ACT project What lies ahead in telemonitoring and ICT for health? • Consolidation of the processes for the acquisition of big data in telemonitoring health applications • Apply ICT for health telemonitoring systems in multi-morbid patients and healthy young individuals for disease management, prevention and behavioral patterns assessment • Identify and use key performance indicators (KPIs) in regional settings to assess CC in telemonitoring • Simplify the interfacing layer by using new I/F technologies • Integrate clouds of BAN big data with social media big data and semantics • Address regulatory and ethical constaints The ACT project Chronic illness poses a huge individual, social and economic burden. In the EU, heart failure alone accounts for over €10 billion per year in direct healthcare costs. Mortality rates are over 30% in patients whose condition is not controlled. Co-ordinated care and telehealth services have the potential to deliver quality care to chronically ill patients. These systems can both reduce the economic burden of chronic care and maximise the delivery of clinical support, despite the shortage of skilled professionals within European healthcare systems. The value of telehealth services has been highlighted in several clinical studies and test cases. However such services haven’t yet progressed substantially beyond pilots because they require new behaviors and ways of working directed at improving health outcomes, administrative efficiency, cost effectiveness and user (patient and health professional) experience. Translating evidence into practice is complex and requires significant organisational change. The Advancing Care Coordination and Telehealth (ACT) programme aims to overcome these barriers. This international consortium of key stakeholders (companies, universities, hospitals and healthcare authorities) investigates best practices in areas such as patient risk stratification, patient adherence, professional engagement, optimisation of organisation and workflow structures, and efficacy and efficiency factors. The objective of this EU co-funded project is to overcome structural and organizational barriers. This will: • Gather data and best practices from 5 regions • Determine a baseline for how care coordination and telehealth works in these regions • Conduct an iterative evaluation of care structures and procedures • Create a best practices “cookbook” to ensure that the findings can be replicated in other EU health regions . The ACT programme is fully aligned with the European Innovation Partnership in Active and Healthy Aging objectives to deploy integrated care for chronically ill patients. Picture from Philips Communications Link to EIP AHA B3: https://webgate.ec.europa.eu/eipaha/act iongroup/index/b3 ACT expected Outcomes • Outcomes: Principal outcome of ACT is the evaluation of key drivers & effective deployment of CC&TH services in the five participating regions, a best practice Cook Book specifying how the drivers can be leveraged to expedite deployment of CC&TH services in other European healthcare regions. Cook Book will provide explicit recommendations & examples regarding key drivers. Recommendations will take into account the regional/national boundary conditions & other diversity aspects. • CC&TH drivers summarised in the Cook Book. – Optimising CC&TH organisation & workflow structures. – Effective Patient Stratification – Improving Patient Adherence and Staff Engagement / Education – Improving Care Provider efficacy and efficiency ACT Objectives • • The ACT programme is the first of its kind, specifically designed to help overcome the barriers hindering care coordination and telehealth deployment. It is specifically designed to concentrate the efforts on the key drivers: Workpackages Objectives Optimisation CC&TH Organisation and Workflow Structures Effective deployment of CC&TH requires modification of the care provider eco-system, ensuring seamless, integrated delivery of patient-centric care. During the Baseline phase, CC&TH concepts and IT solutions in the regions are evaluated. Patient stratification Ensure CC&TH services can be tailored to needs of individual patients, accurate/easy to apply patient stratification tools are required: evaluate solutions (Baseline), optimise/enhance tools during Iteration phase, identify best in class solutions. Improving Patient Adherence and landscaping of staff engagement concept Evaluate current staff engagement and educational packages used within the region to support Care Coordination & TeleHealth, and provide this overview as part of the overall ACT evaluation package. Investigate how patient anxieties can be overcome & services effectively implemented to improve patient empowerment & adherence. After interactive phase (M24) service & solutions have been evaluated & concepts improving outcomes listed. Improving care provider efficacy & efficiency Clinical staff shortage mandates that existing resources are effectively utilised & deliver quality care. Assess guideline based CarePathways & algorithms targeted at HF,COPD, diabetes & comorbidities. Improve nurse/patient ratios. WELCOME project – Multimorbid patient integrated care model Biosensors recording evolution enabling higher dimensionality in biodata acquisition passive probes classical approach standalone sensors active probes (sensors) + in-situ electronics (allow optical and acoustical sensing) + simple connection (no cable) 2-wire bus for: ECG, EIT, isochronous synchronization, communication and simultaneous recharge state-of-the-art sensors (developed by CSEM) top: standalone sensor for one-lead ECG bottom: active probe for ECG and SpO2 (at chest) frontend analogue electronics outer ring for current injection (EIT) microcontroller for data acquisition & processing isochronous synchronization mechanism and communication intermediate ring made of electret for sound measurement simultaneous recharge mechanism inner ring for voltage measurement (EIT and ECG) SPLENDID project – Prevention and coaching of healthy young people Smart Dietary Monitoring Sub-System Components EAR-CH-SW SENSOR (EARCS) CHEWING-SWALLOWING SENSOR INTEGRATED TO EARPHONE SET ON-BODY DEDICATED DEVICES - EARCS (embedded sensor in earphone set) - Electrodes chewing / swallowing detection - Embedded in standard fancy earphone set - Sensor & audio wiring embedded - Signal / Audio connector to ADL Wireless Local Area Network (WIFI) Wireless Wide Area Network (GSM, GPRS, UMTS) - ADL (in-pocket/belt) - Sensor input analog front end / data acquisition - Chewing/Swallowing detection algorithm - Embedded accelerometer (ACC) - Activity classification and energy expenditure - User presence / absence detection - Wireless DATA communication to SP - Wired (standard) AUDIO connection to SP PERSONALIZED MONITORING AND GUIDANCE PLATFORM DATA TRANSMISSION MOBILE PHONE MSGS, MUSIC, ETC. USER PRESENCE/ABSENCE CHEWING &/OR SWALLOWING DETECTION ACTIVITY CLASSIFICATION ENERGY EXPENDITURE ACCELEROMETER DATA LOGGER (ADL) SMARTPHONE OR EQUIVALENT (SP) Smartphone (User interface/Gateway) MEAL INTAKE - GUI application (PMGP-SP) - Monitoring / Feedback - Gateway Bluetooth 4.0 or ANT+ Bluetooth WiFi EDGE ; GSM/GPRS ; UMTS Mandometer (MMT) - Food consumption during a meal - Communication bridge to SP (tbd) Conclusions • Large scale data are a function of sensor recording capacity, ICT barriers (e.g. network availability, communication means), energy scavenging, knowledge management & engng, patient empowerment, regulatory & ethical constraints, adaptability of clinical trial protocols, integration of social network information and semantics, regional KPIs, virtual physiological human models, computational resources…….. • We are currently still in the beginning of a long journey to the unknown world of big data • We need tools and means to be able to navigate so as to achieve efficient CDSS, patient adherence, personalized health and production of solid evidence based medicine