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Investment in Healthcare for the Prosperity of People and the Economic Wealth of Nations
Real Life Examples – from Prevention to Therapy o o o o o o o o o o o DIAGNOSIS and THERAPY – Medication process INFORMATION MANAGEMENT – Patient-centric processes DIAGNOSIS – Cardiovascular Diseases TREATMENT - Cardiovascular Diseases INFORMATION MANAGEMENT – Cardiovascular Diseases PREVENTION – Cancer SCREENING – Cancer DIAGNOSIS – Cancer TREATMENT – Cancer TREATMENT – Long Term Care TREATMENT – Intensive Care
Looking forward o DIAGNOSIS – Cardiovascular Diseases (Annex 1) o SCREENING – Cardiovascular Risks (Annex 2) o SCREENING – Cancer (Annex 3) Conclusions
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Investment in Healthcare for the Prosperity of People and the Economic Wealth of Nations
The Challenge – Health and the Economy Modern health care faces a change of paradigm. Health expenditure is increasingly being regarded not as a burden but as an investment for the future. A health burden leads to economic loss and threatens the Lisbon Agenda for growth, competitiveness and employment. It is vital that Europe reduces its health burden in order to decrease economic loss in view of the following factors: ageing population, decline of human capital and increasing competition on the global market. Health is therefore not only an investment to the benefit of individual citizens and their quality of life, but also to the economy. A healthier population leads to a healthier economy with higher productivity, increased labour supply, education and increased sustainability of public finances. But the personal well-being of the population will only be increased when the health of society as a whole is in the focus of health policy and the required investment is being made. According to a study of the WHO*[Macroeconomics and Health: Investing in Health for Economic Development, Report on the Commission on Macroeconomics and Health, Jeffrey D. Sachs, WHO, 20 December 2001] an average increase in life expectancy by 10 years will add 0.35 percentage points to the growth of the Gross Domestic Product (GDP) of a country. A society in bad health will be a burden on the budget of a country. A society in good health will raise productivity and contribute to sustainable long term growth. 50% of the difference in economic growth between rich and poor countries are connected to bad health and lower life expectancy of the population. In addition, while there is a direct effect of health on the economy, there is also an impact of the health system on the economy simply because of its size. Health care represents one of the most important sectors of the economics in developed countries and accounts for 9% of GDP in the EU member States- and rising. Expenditures that improve the health of citizens and focus on increasing healthy life years is therefore not a cost to society but rather an investment for its future. Health Care – A Vital Part of a Country’s Infrastructure The Member States of the European Union are connected by motorways, rail links and airways. Borders across regions and countries are disappearing quickly. People are moving around the Union for purposes of travel, study, work and retirement. Why health care is lacking behind? Health Care, too, will need shared infrastructures that improve health and support the strategic objectives of prosperity, solidarity and security within regions, countries and across Europe. Social and economic cohesion depend as much on economic development as on similar living conditions. A modern health care system, delivering high quality of care, is one of the major building blocks for the economic development of a region, a country and Europe as a whole. While the economic argument for investing in health in low income countries might differ in detail from high income
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countries, recent evidence show that significant benefits can be achieved by improving health infrastructure not only in developing, but also in developed countries. Policy makers who are interested in improving economic outcomes would have a strong case for considering investment in health infrastructure as one of theirs options by which to meet their economic objectives. The EU Structural Funds are providing the opportunity to new Member States and Accession Countries but also to all Regions of Europe to speed up the process of development. It is necessary that health care should be regarded as a vital part of a country‟s infrastructure in this framework. Health Care – The Need for a Holistic Process-oriented Approach It is essential to understand modern health care as a continuous and interlinked process. In a modern health system the complete care process consists of prevention, diagnosis, therapy, rehabilitation and long term care. Each of these steps as well as the continuum of care process as a whole need to be optimised, with the citizen-patient at the centre of all efforts. The goal is to help the citizen increasing his/her healthy life years and to help the patient get better as quickly and with as little burden as possible. To do so, medical professionals, nurses and other staff need to have all relevant information and knowledge available in the right form at the right point of time and the right point of care. Working towards such a process-oriented health care system requires joint efforts by all stakeholders in order to use the limited resources available in the most efficient way, without compromising the well-being of the individual citizen..
Improving Health Care Quickly – Delivery the quality of care we are entitled to In order to identify the “low hanging fruit“, one needs to understand and analyse the enormous positive contribution of standardised care processes and clinical pathways to the improvement of quality and efficiency of health care. A study performed by the US Institutes of Medicine with the title “To Err is Human” (2000) estimates that approximately 90,000 deaths per year are caused by “adverse events” during the treatment of patients. A second report “Quality Chasm” (2001) revealed a wide “chasm” between the quality of care the health system should be capable of delivering today and the quality of care most people received. It is widely believed that the situation in many,
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if not all European health delivery contexts is characterized by similar, if not the same deficiencies. These findings are confirmed by the Agency for Healthcare Research and Qaulity which states that there are more deaths per encounter with the healthcare system than for any of these other activities.
Source: AHRQ, Commission on Systematic Interoperability, USA, 2005 It is therefore obvious that investment into quality, safety and and efficiency of health care services will be highly beneficial to the individual citizen-patient as well as society as a whole. While medical information and communication technologies can be useful in almost every aspect of healthcare, including, simplifying diagnostic and therapeutic processes, preventing by making use of advanced screening technologies, enabling patient-centric workflows, facilitating information and communication within and among healthcare organisations, reducing costs, increasing the efficiency of care delivery, increasing the quality of care provided to patient, including improvements in patient safety, show the highest potential for improvements. The recent IOM/NAE report, “Building a Better Delivery System: A New Engineering/Health Care Partnership” underscores the importance of medical, information and communications technologies for meeting multidimensional performance challenges. It also identified proven, fundamental engineering concepts, such as designing for safety, mass customisation, continuous flow, and production planning, that could be brought to bear immediately to redesign and improve care processes to deliver greater patient safety and better quality. Furthermore, Wachter indicates that “it seems self-evident that many, perhaps most, of the solutions to medical mistakes will ultimately come through better information technology.” This development, he adds, is fuelled by the activities of the Leapfrog Group in the USA, a coalition that promotes patient safety. The National Audit Office in
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the UK also sees the preventing of errors by the appropriate use of information technology process-oriented as a well established fact.
Medical Technology - Essential Part of the Solution Innovative medical technologies are offering a range of solutions to address questions associated with the early detection and diagnosis and the efficient treatment of many diseases. From today‟s perspective, almost all widespread chronic diseases can be treated successfully, if they are detected and diagnosed early enough. Even if the health care systems differ between the Member States of the EU, the disease burden and the problems associated with these diseases are almost identical. Following well organized preventive measures, a process- oriented, efficient collaboration of medical professionals and other health care staff is required in order to ensure the best health care process. Ideally, this should be possible across borders, supporting the free movement of citizens in the EU. Also, regular preventive examinations, e.g. for cardiovascular risks or specific types of cancer, can save lives! Reliable diagnosis with up to date imaging equipment improves treatment decisions by medical staff. This again helps to avoid unnecessary medical procedures to the benefit of the patient and society as a whole. Highly efficient therapies like the use of linear accelerators in radiotherapy can kill cancer tumors quickly, while not damaging other healthy tissue in the body of the patient. Researchers in life sciences and industry are permanently looking for new solutions helping to detect and treat diseases earlier and more reliably. Health ICT Technology – Connecting Stakeholders for sharing health knowledge Modern Health ICT systems (the so-called Connected Health or eHealth) provide the possibility to make all relevant information concerning an individual citizen-patient available at any place and any time but has also the capability to support clinical decision 5
and to bring clinical knowledge to improve patient outcomes and make clinical services more effective. Networked IT systems in hospitals, doctors‟ offices and at home improve the way of working and permit a seamless flow of information. Health ICT systems and the shared eHealth infrastructure support and enable all steps along the patient-centered care process: from examination to electronic prescription in the doctor‟s office, from admission to discharge in hospital and including rehabilitation and long term care. In this way, all steps along the patient care process are becoming transparent for all stakeholders, including the citizen-patient. This helps to avoid possibly fatal mistakes, improves the quality of care and reduces cost. Real Life Examples – From Prevention to Therapy The following examples will highlight how to improve efficiency and quality in healthcare. They will show how this is beneficial for the patient and at the same time cost efficient for society. The examples will cover the areas from prevention to therapy, thus covering the complete care process. They will also highlight how to continuously improve this process. DIAGNOSIS and THERAPY - Medication Process The study from the Institute of Medicine in the USA, that has been mentioned earlier, has resulted in similar studies in a number of European countries. The European Commission estimates that as much as 10 % of all hospital admissions may be due to medication errors. This is making medication errors one of the leading causes of death worldwide, even more relevant than traffic accidents, breast cancer or HIV/AIDS. Computerized Order Entry Systems in hospitals can significantly reduce these errors. Soedersjukhuset, a Stockholm hospital, has reported a drop in erroneous or unclear medications by 73 % after introduction of such a systems, based on modern IT. The Cincinnati Children‟s Hospital in Ohio, USA reports 35% less medication errors and a 52 % reduction in the time from prescription to dispensing the medicine. It is realistic to consider to establish similar systems for a healthcare system in total, including doctors‟ offices and pharmacies. Any new prescription could then be checked against information in an Electronic Health Record (EHR). The EHR would contain the medication history of this patient, including allergies and chronic diseases, which could influence the medication. The medical professional would be warned about any contraindication regarding a specific medication. Nevertheless, medical professionals would be fully in charge of the decision making process. A system as described can only support decision making, but not replace the decision taken by a qualified medical professional. Many stakeholders in healthcare systems see the huge advantages of such a solution. Many countries are working on the implementation. Results from better medication process management
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CASE: Information Management – Patient-centric processes Healthcare delivery systems are in crisis, due to escalating demands for more services of higher quality. There has been a singular failure within the industry to significantly raise the productivity of healthcare professionals. Health care remains very administrative (only 30% of healthcare employees are dealing with patients). Productivity of healthcare professionals is low (30% of nurses time is dealing with administrative issues). Standards take too much time to find their ways in clinical routine (17 years according to US sources).The locations in which health care is provided are constantly changing as getting closer to the citizens-patients. The ways of working are also changing with the emergence of care pathways and integrated patient workflows. As a result, healthcare systems are typically inefficient, prone to serious levels of error and becoming an increasing burden on patients, providers and governments. Connected Health (so-called eHealth) has the means to tackle rising costs and improved productivity to get the necessary Return On Investment in order to invest in improved patient care and better clinical outcomes. In this respect, one of the most important developments in eHealth in recent years in many countries across the globe has been the slow move from a paper to an electronic based patient record system. The study from the Institute of Medicine in the USA, that has been mentioned earlier, advises that EHR (Electronic Health Record) would be the single step that would improve quality of care and patient safety. While EHRs are widely recognised as „Holy Grail‟ for Healthcare, investing in a shared infrastructure is not sufficient to support the modernization of healthcare and its transformation into a more „consumer led‟ delivery services. Today, all experts agree that „isolated‟ care practices are living their last days. However, they also highlight that trading up the information capacity at the providers side is to a pre-requisite to the development of networked services providing seamless care to informed public, the socalled eHealth. As highlighted during the high-level eHealth conference in Malaga (May 2006), “…Real eHealth cannot happen without trading up the information capacity at the health professionals‟ level. For example, the quality of an EHR summary is largely dependent on the basic patient records from which it is abstracted. In this respect there is still much to be done in terms of implementing an EHR solution effectively on a large scale at the point of care. We need to focus on in-depth institutional solutions and functional richness to allow cross-sharing and learning at the point of care…” Care processes have indeed received little attention so far across Europe but are becoming more and more important as cost containment policies (e.g. DRGs) push care providers to share workflow and collaborate across organization boundaries. However, developing a more patient-centric approach implies a radical shift, from focus on departmental care delivery to patient-centred, seamless multidisciplinary team both intra-
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and extra muros. The ability of care providers to communicate, interpret and act intelligently upon complex health information is therefore gaining paramount importance. The next step lies therefore in the implementation of flexible component-based solutions than can operate seamlessly within the workflow of a care provider and across providers within the wider healthcare environment it operates. Major areas of improvements remain therefore in advanced hospital-wide clinical applications surrounding electronic patient records and supporting care providers and specialists in managing care across the continuum. Policy makers and care providers that want to successfully meet the future of healthcare have therefore compelling reasons for embracing leading-edge technologies amongst which Advanced Electronic Patient Record (EPR) systems: to improve clinical documentation formats and decrease variations across departments and clinicians, to reduce physical storage requirements and to reduce the amount of time spent retrieving information, to avoid duplication of acts/exams due to more intergration and sharing, etc. Order entry systems: to reduce time to place order, to ensure correctness, legibility and completeness, to eliminate staff-intensive paper processes, to rovide direct alerts for abnormal results and reduce adverse events, etc. Medical documents management systems: to reduce time required for staff to manage paper and re-allocate time to care processes Knowledge/decision support systems: to provide guidance and generate alerts and reminders
In a survey conducted for the European Commission, the research organization empirica highlighted similar results at the Institut Curie in Paris (France) when assessing the costbenefits of a comprehensive EPR system associated with a sophisticated search metaengine. The chart below summarizes their findings and presents the values of annual costs and benefits during the period 2000- 2008 (in € 000s).
Source: empirica for EC DG INFSO, 2006
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As further described by Hillestad and colleagues in a study entitled “Can electronic medical record systems transform healthcare?”, after full adoption, $81 billion or more could be saved annually through improvements in healthcare delivery effiencies from using Electronic Patient systems. Transaction efficiencies could add another $10 billion or more in annual savings. The organisation‟ability to reengineer existing healthcare delivery processes through the EHR framework will indeed improve the sharing of information and will ultimately provide for better-quality healthcare, improve access to care, greater cost-efficiencies. Antony Bower even suggests that these savings could be more than double again –to $346 billion a year or more – if healthcare were transformed sufficiently. There is no reason to believe that similar benefit projections could not be expected in Europe. To sum up, there are sufficient evidences for the countries and regions of Europe to invest now in policies, programmes and projects to speed eHealth adoption and start from where the information is generated, at the point of care, by promoting standard-based electronic patient records adoption. As concluded within the industrial round-table chaired by the European Commission at the high-level eHealth Conference, “Whether near or longer term, what is certain is that the vision of the future starts TODAY. Achieving healthcare modernisation objectives requires immediate actions and longer term eHealth scenarios to enable the change process.”
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DIAGNOSIS – CARDIOVASCULAR DISEASES
Multislice Computed Tomography Fast Food, the beer after work and the cigarette against stress during the day – unhealthy habits which affect the heart and the cardiovascular system. The number of cardiovascular cases is increasing constantly. The precise, quick and non-invasive view into the body is therefore becoming more and more important. Multislice Computed Tomography (MSCT) can provide high-quality images even of quick moving parts of the body, like the heart. The invasive heart catheter is not necessary any more for diagnostic procedures. Different to classical X-Ray examinations, images taken by CT show crosssectional images of the body. This is possible since the X-ray source is rotating together with the detector around the body of the patient. The result is a large number of so-called cross-sectional images with high resolution, which are composed to 3D impressions of the body. Technological innovation of the past few years is now allowing MSCT to take images of the complete cardiovascular system. The latest MSCT systems can even deliver images of the moving heart and its vessels in real-time. This enables a so-called fourdimensional, dynamic evaluation of the health status of the patient. The advantages for the patient are manifold: The examination takes much less time. Most systems can do so-called “full body scans”, reducing the need for several appointments in order to study different regions of the body. The medical professional can acquire the images quicker and with higher quality and reliability for diagnosis. All this results in shorter waiting times for the patient between the examination and the result of the diagnosis. As a noninvasive procedure this examination is also beneficial to the patient, since there is no need to use the invasive method with a diagnostic catheter, which is the standard procedure today. In addition, there is positive effect on health expenditure, since catheter examinations are also more expensive. The whole heart in 5 beats The rapid advancement of multi-slice computed tomography (MSCT) technology over the past 5 years or so has greatly improved its spatial & temporal resolution & expanded its application to coronary angiography. There is mounting evidence that the latest generation 64-slice instruments now have the ability to rule-out haemodynamically significant stenoses and replace invasive, catheter-based coronary angiograms in selected clinical settings with associated clinical & economic benefits. Myocardial infarction, however, usually occurs due to sudden occlusion of a coronary artery. The underlying cause being atherosclerotic
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plaque formation within the arterial wall, which may rupture suddenly or which via various mechanisms – may contribute to thrombus formation in a patent artery. It is likely that such thrombi often remain unnoticed and undetected as they are non-occlusive. Due to a number of self-repair mechanisms, such thrombi will be remodeled and the plaque will grow. Such remodeling will initially not reduce lumen diameter but the vessel increases its outer diameter, a process known as vessel remodeling. Despite a large plaque burden, blood supply to the heart is preserved, the patient will not experience symptoms & such plaques will go undetected by conventional imaging techniques. Pathologic-anatomic findings suggest, that such a sequence consisting from plaque rupture healing formation of new atheroma repeat rupture healing etc., represents the primary mechanism of plaque progression. This process likely occurs in repetitive episodes which are comparable to wound healing. If, however, such a thrombus develops from a so called “vulnerable plaque”, grows rapidly and acutely interrupts blood flow over a longer period of time, a myocardial infarction will occur. While standard risk factor assessment provides a statistical estimate of risk, imaging-derived parameters allow direct visualization of plaque formation within the arterial wall and are providing new insights into plaque development, progression & individual risk of major cardiovascular events. Vulnerable plaque research is advancing rapidly through the development of invasive, catheter-based imaging procedures such as IVUS, OCT, intravascular MRI, and nuclear probes. However, in the case of vulnerable patients, the ultimate goal of diagnosis should focus on non-invasive approaches to the assessment of plaque burden and plaque characteristics such as morphology and inflammation. CT is a cross-sectional imaging technique and thus has the potential to show not only the contrast-enhanced lumen of the vessel but also to characterise the vessel wall and the severity of atherosclerotic burden.
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TREATMENT – CARDIOVASCULAR DISEASES 3-Dimensional Presentation of Coronary Vessels Calcifications in arteries can limit the capacity of the vessel or even block the vessel completely. This is called a stenosis. As a consequence, the heart muscle is no longer sufficiently supplied with oxygen and other essentials. This can result in a cardiac infarction. The situation can be corrected with the use of a minimally invasive procedure called angioplasty. In this procedure, a balloon catheter is used to reopen the blocked vessel. The catheter will be advanced from the hernia through the larger blood vessels of the body to the heart and the place of the stenosis. This process is supervised with the help of dedicated X-ray systems. When the catheter has reached the stenosis, a small balloon at the tip of the catheter is being inflated, which widens the vessel and reopens it. This process is called dilatation. To prevent the vessel to block again, a so-called “stent” is often placed in the vessel. A stent is a small tube made of wire. The stent is introduced into the vessel together with the catheter. It is pressed against the walls of the vessel from the inside and stabilizes the walls of the vessel. Determining the degree and the length of the stenosis is difficult, when only conventional two-dimensional images are available. The degree of the stenosis is of relevance for the decision about treatment. The length of the stenosis is especially important, when a stent shall be placed in the vessel in order to determine the required size of the stent. Three-dimensional presentations of the blood vessels in the area of interest do contribute significantly to the decision–making of medical professionals. Approximately 25 – 30 percent of patients suffer from a re-blocking of the vessel after the placing of a stent. The correct calculation of the required length of the stent can reduce this share considerably. Modern angiography systems can exactly show the location, the size and other information concerning the blocking of vessels. A dedicated software is combining the information from two-dimensional images of the area of interest and calculates a three-dimensional presentation of the vessel in question. To do so, only two images of the area of interest from different angles are required. The 3D presentation is then displayed on a monitor. The presentation is „virtual“ and can be accessed from all angles and perspectives. In contrast, a two-dimensional presentation may lead to wrong calculations regarding the length of a stenosis, because a stenosis that is following the view angle will look shorter than it is in reality. Only a presentation in three dimensions will avoid this risk.
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The patient will benefit form this procedure since additional interventions, e.g. to place another stent, can be avoided with the help of the three-dimensional presentation. Cost are in the end reduced.
Presentation of the opening of a blocked vessel by angioplasty
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INFORMATION MANAGEMENT – CARDIOVASCULAR DISEASES The glue in the process - Comprehensive cardiovascular IT solutions Over the past few years, digitization has contributed greatly to rapid improvements in efficiency, quality, and patient outcomes. Information Technology-based disease management will help to provide the most complete set of data at the shortest possible time to physicians for better and faster decision making (Electronic Patient Record EPR, completed with all imaging and ECG data as well as patient history). The future will show many more advances in fields like the interventional suite, aiming at further clinical utility and procedural efficiency. For instance will images from multiple modalities such as cardiac X-ray, CT, MR, IVUS, ICE be seamlessly integrated in the interventional suite to improve the efficiency and outcomes of complex procedures such as ablations and bi-ventricular lead placement. Imaging, information technology, and device technology will converge to provide optimized device visualization, or automated information flow for implant procedures.
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PREVENTION - CANCER Virtual Examination with Computed Tomography (CT) Bowel cancer is the second most frequent type of cancer behind lung cancer. In the European Union, for example, between 65.000 (Germany) and 5.500 (Greece) [Estimated data, Robert-Koch-Institut] patients are diagnosed with this cancer annually. Prevention and early detection can save lives. If the disease is diagnosed in an early stage, 90 percent of the patients could survive. However, many patients refrain from a preventive endoscopic examination, because it is unpleasant. Virtual Colonoscopy based on CT, which is non-invasive and capable to detect polyps as well as lesions, is therefore an important alternative preventive measure.
Images from a Virtual Colonoscopy
The examination is much more comfortable to the patient and much quicker. The results are comparable with regard to quality and reliability. With the help of a CT system several cross-sectional images of the abdomen are being taken. With the help of a specific software, the medical professional can then view a three-dimensional presentation of the complete bowel. He can take a virtual „flight“ through the complete organ, thus accessing even parts of the bowel that cannot be reached by endoscope. Since the procedure is computersupported, the time from the CT examination to the diagnosis is about 10 minutes only.
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SCREENING - CANCER
Introduction: A brief statement on MR Breast Imaging strength. MR has a High sensitivity but a lower specificity. Conventional mammography remains the primary diagnostic tool for breast cancer. It offers morphology information of the lesions and detects the presence of micro calcifications, an important sign for detecting breast cancer. Mammography limitation being a reduced sensitivity in dense breast. Breast MR has already been widely accepted as a very sensitive technique in the detection of infiltrating carcinoma, with a sensitivity ranking from 94% to 100%. However, no similar consensus occurred on specificity figures. Specificity of breast MR was ranked from 37% to 98%. Obviously, this extremely wide range took place because of the difference in MR acquisition and processing techniques used by people from different institutions. MR Breast Imaging: current indications. If some technical controversies persist, there is already strong scientific evidence of the clinical relevance of Breast MR in detecting invasive cancer. Some clinical indications of breast MR are nowadays well established: Preoperative Breast cancer staging , Discrimination between fibrosis and recurrent cancer, Some recent publications clearly suggest that breast MR in combination with mammography is the technique of choice for screening of high risks patients such as the ones with proven BRCA1 & BRCA2 genetic mutation. MR Breast Imaging: Morphology and Kinetics assessment of both breasts. MR imaging enables both High Contrast Assessment, relatively High Resolution Imaging as well as Dynamic Contrast Enhanced imaging (DCE) where breast cancer tissues demonstrate a greater signal enhancement than normal fibroglandular that thus allows wash-in / wash-out analysis. Different enhancement patterns in DCE have been described. In the vast majority of cancers, a rapid enhancement during the first minute after contrast injection is usually followed by a peak enhancement in the second minute that then exhibit a plateau or a washout. A good Morphology should exhibit the higher spatial resolution possible. A good kinetic analysis is characterise by a one minute temporal resolution during six minutes after contrast injection.
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MR Breast Imaging: Pre-requisites A Dedicated Coil. Along with the technical pre-requisites described in the previous paragraph, the necessity of image–guided wire localization or core biopsy of suspicious lesions is emphasizing the need for dedicated coils allowing full organ coverage as well as axillary coverage. Accreditation process will more and more emphasize this need. Custom made solutions does not provide enough patient positioning repeatability and Image Quality. A Dedicated Acquisition Package. Sequence optimization necessity also requires a specific package to achieve whole organ coverage compatible with kinetics characteristics. A Dedicated Post Processing Package. The large amount of data to process has lead to the development of software tools to ease the different steps of data processing. These tools permit the construction of coloured maps that allow to analyze at first glance normal and suspicious tissues behaviour.
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DIAGNOSIS - CANCER
Hybrid-Systems for Diagnosis: PET-CT X-ray examinations with CT systems permit detailed presentations of all the structures in the human body. If a tumour is detected, it is essential to determine whether the structure is a benign mass or a cancer Making this distinction is the domain of Positron Emission Tomography (PET). To perform a PET examination, a radioactively marked substance is introduced in the circulatory system of the patient. The radioactivity of the substance is not dangerous to the patient, but sufficient to be used for diagnosis. In most cases radioactively marked sugar, e.g. glucose, is being used. Since cancer cells require especially high amounts of energy for their rapid growth, the marked glucose will be concentrated in these tumours. The radiation form the decay of the marked sugars is being detected with highly sensitive detectors in the PET system. The radiation is used to locate the tumour, the intensity of the radiation indicates the activity of the tumour. Based on this information, an image is being calculated, which can be used by the medical professional to determine the nature of the structure. PET systems are very often used to stage the primary tumour and check for possible metastasis. The functional data generated by a PET examination can be improved, if they are combined with the structural (morphological) information from CT examinations. Ideally this is being done in a single examination using a socalled PET-CT system, which combines both examinations. Through the combination of simultaneously generated images, from both systems, the medical professional can determine the size and location of a malign tumour down to fractions of a millimetre. This information is essential in order to plan and perform cancer therapies, which may save the life of the patient.
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On the left hand side: CT image of the lung (left), PET image of the same area (middle). On the right hand side: combination of both images, allowing exact localisation of the tumour and determination of size (right). Arrows in the images indicate the tumour.
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TREATMENT - CANCER Radiotherapy – Linear Accelerators and Imaging Equipment Cancer cells are greedy. They grow extremely quickly and consume a lot of energy within the body. Treating cancer means to stop cancer cells from growing. This requires specific therapies. In addition to surgery and chemotherapy, radiotherapy has been established as an effective therapy in more than 60 percent of all cancer cases. The principle behind radiotherapy is to destroy tumour cells on the surface of the body or within the body through targeted high energy radiation. Surrounding healthy tissue and neighbouring organs will be affected as little as possible. To do so, exact information about the location of the tumour and the surrounding organs is required. Oncologists gather this information from a range of modern imaging procedures. These include: Magnetic Resonance Imaging (MRI), Computed Tomography (CT) or the combination of CT with other examinations like Positron Emission Tomography (PET) or Single Photon Emission Computed Tomography (SPECT). With the help of these procedures, malign tissue becomes visible and can be targeted exactly with the radiation. It is also possible to control the effect of the therapy. The amount of radiation that is required for therapy has to be calculated individually by the medical professional. The required amount will then be applied to the patient in several sessions with the help of a specific radiotherapy device, a linear accelerator. Radiotherapy addresses a natural process in the body: cell replication. The human body is constantly replicating cells with the help of cell division. Tumour cells do divide more quickly and more aggressively than healthy cells. The energy of the radiation applied through radiotherapy is changing the core of the cancer cell in such a way that it is no longer able to divide and replicate. If healthy tissue is hit, it normally regenerates due to its self-repairing mechanisms which are better developed than those of the cancer cells.
Radiotherapy Treatment Planning Multislice Large Bore Computed Tomography Within the last 10 years, radiotherapy have seen huge clinical and technological innovations such as 3D dose planning, Intensity modulated radiotherapy (IMRT) and Image Guided Radiotherapy (IGRT). The main goal of those new techniques is to dramatically improve the local control in order to better map the dose distribution on the volume of interest and avoid at maximum the organs at risks. To achieve this therapeutic goal, precise
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geometric knowledge of the target is needed. Therefore all those new techniques moved from 2D treatment planning made with x-ray radiographs systems named x-ray simulators to 3D and even 4D treatment planning based on Computed Tomography (CT) images.
Different to classical X-Ray examinations, images taken by CT show crosssectional images of the body. This is possible since the X-ray source is rotating together with the detector around the body of the patient. The result is a large number of so-called cross-sectional images with high resolution, which are composed to 3D impressions of the body. Moreover, the intrinsic relationship between CT numbers and tissue density provide the required data for treatment simulation and planning software to accurately calculate the dose distribution within the patient. Many radiotherapy treatment techniques implies specific patient positioning in order to avoid the irradiation beam to get through organs at risks (ie.: breast treatments ). Also, radiotherapy treatment being delivered daily during 5 to 8 weeks, the patients have to be precisely repositioned with great reproducibility using specific immobilisation accessories. Multislice Computed Tomography (MSCT) provides very high-quality images which allow radiotherapy physicians to accurately delineate target volume(s) and define the best treatment ballistic in 3D. However this is only clinically relevant if the patient is scanned in true treatment position with the positioning devices. Both the patient position and the accessories presence can be difficult to accommodate in a standard diagnostic MSCT tunnel (70 cm). Therefore, radiotherapy MSCT are now designed with a larger bore (>= 80 cm) to cope with this patient treatment conditions requirements.
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Recent technological innovation is now allowing Multislice Computed Tomography (MSCT) to acquire 4D data set showing possible tumour movements due to patient respiration and can help define gating of treatment in such difficult localisations.
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TREATMENT – Long Term Care IT-Supported Disease Management – Efficient Treatment of Chronic Patients The WHO concludes that 60 percent of all health expenditure worldwide is being used for the treatment of chronic diseases. The number of patients suffering form chronic conditions will be increasing in the next years. The number of diabetic patients is expected to double to 340 million worldwide until the year 2025. This development will burden health budgets in the future and may easily overburden them. Information and communication technologies have already proven that they can improve the quality and efficiency of treatment of chronic conditions significantly. In addition to educational and preventive measures for the population as a whole, it is essential to establish new procedures for the treatment of patients under chronic health conditions. These procedures will have to optimize the treatment of patients in their daily environment, help to avoid complications and a deterioration of the health status of the patient. For diabetics, asthmatics and patients suffering from cardiovascular conditions, the monitoring of vital parameters like the blood sugar level, the peak flow value or the body weight, may contribute significantly to the early detection of changes in the health status. If this monitoring is done in the daily environment of the patient, this will contribute to avoid costly stays in hospital. Trials have shown that the use of electronic patient records, call centres and the increased participation of patients can help to reduce by half the number of hospital admissions of patients suffering from cardiovascular conditions.
IT solutions can also contribute to the effective organization of measures for secondary prevention. For example, diabetic retinopathy is a complication that 60 percent of all diabetics develop. If not diagnosed in time, this can lead to permanent blindness. However, 90 percent of cases can be treated successfully, if diagnosed early enough. IT solutions can help to organize the prevention process and ensure the quality of preventive measures. Besides the improvement in the quality of life for the patients with chronic conditions, IT supported disease management will help to control healthcare expenditure significantly.
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A promising project for disease management with IT in Scotland
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TREATMENT – Intensive Care Integrated Workplaces in Intensive Care and Operating Room Perioperative medicine is the biggest single cost factor in the care process in hospitals not only for multimorbid patients, which are suffering from several diseases at the same time. Perioperative medicine consumes considerable resources both in the operating room (OR) as well as in the intensive care unit (ICU). In the ICU and OR it accounts for approximately 90 percent of staff cost. The medical devices used for monitoring and supporting life-critical organs are subject to continuous innovation and improvement. This also affects patient safety, safe use of devices and improved therapies. In OR and ICU as well, the coherent use of technologies for the improvement of clinical work places can contribute to more efficient processes and cost reductions. One of the technologies used are so-called “virtual local area networks” (Virtual LAN). A Virtual LAN can connect all systems used for therapy, monitoring and documentation without the need to install a separate, dedicated network of its own. Virtual LAN can use the existing network in the hospital or use wireless technologies. Integrated work places will also use a uniform user interface for all medical devices connected to the work place. This is supporting and facilitating the safe use of equipment as well as the training of staff. Integrated work places do connect all sub-systems integrated into the workplace. This enables for example plausibility checks between different devices that help to avoid false alarms. This is especially relevant since in the case of stand-alone conventional devices 80 percent of all alarms are false alarms without a critical situation for the patient. Dealing with such false alarms is a major burden for staff and consumes considerable resources. In addition, the networking of different devices enables new therapy procedures. Combining measurements from monitoring equipment with the control of therapy systems will considerably improve the effectiveness of life supporting equipment compared to a manual control of therapy devices. A fully integrated work place will provide the medical professional with all relevant patient information for the optimal therapy decisions. This can even be supported by automatic recommendations for specific procedures or clinical pathways, based on the available information and the comparison with data stored in the Electronic Health record (EHR) of the patient. One example for an already existing solution making use of such technologies are automated controls for clinical respirators. Automatic control of the respirator, a device supporting the breathing of unconscious patients, will 27
reduce the artificial interference with the breathing system of the patient to the minimum. It will also speed up the „weaning“ of the patient from breathing support and restore his natural breathing. This will not only reduce potential negative effects for the patient, but will also reduce the length of stay in the intensive care unit as well as free staff to perform other care tasks. Integrated systems also offer closed-loop feed-back control mechanisms for the exact dosage of medicines during intensive care and surgical interventions. This will not only reduce the consumption of pharmaceuticals but also facilitate the safe use of the equipment. It will be crucial for the hospital administration to have a transparent overview of the processes in the hospital. They must have the tools available to adapt and optimize the processes, due to the changed reimbursement system, which has moved from reimbursing individual cases towards average cost reimbursement (Diagnosis Related Groups). In the language of the modern industry: Full cost Accounting To secure the information, an appropriate IT environment has to be in place, which has all the variables available to manage an optimal process flow in the hospital. At the same time equipment should be flexible and be equipped with an easy and uniform user interface. Here lies a responsibility for the healthcare industries of today and tomorrow. Finally, the fact that most technologies make use of a web-based software environment opens the possibility for remote service of the equipment. Through the use of telematic services a service centre is able to control the performance of the equipment and initiate preventive inspections of the equipment, when necessary. This will help to improve the availability of the equipment for use. In the case of failure or malfunction, the service centre can diagnose the failure and make sure that the appropriate service technician with the right spare parts is being dispatched to fix the system as quickly as possible. Alternatively, the remote service may help the technician on site to find the source of the failure and correct it without the need for a service technician to visit the hospital.
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The duration of inadequate ventilation (length of bargraphs) on ICU is significantly reduced by automatic and seemless adaption of ventilator support compared to adaptation in clinical routine procedure by medical staff.
Example of intuitive and unified graphical user interface (GUI): Touch control for all workplace components (cockpit design approach). Example shows the effect of stepwise automatic adaptation of ventilation support. The stepwise adaptation over time (s. lower diagram) results in the desired patient status of normal ventilation (s. trend graph in the middle).
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DIAGNOSIS – CARDIOVASCULAR DISEASES (Annex 1) 4D Ultrasound In the area of Heart Failure (HF) real-time 4D ultrasound gives colour-coded information of hemodynamics and allows full left ventricle volume assessment within the same heart cycle. This way the pump function can be precisely quantified. Another rapidly evolving field for ultrasound is the assessment of wall motion abnormalities and asynchrony of ventricles. Technologies like Tissue Synchronisation Imaging (TSI) quantify left ventricle synchronicity for heart failure patients or those undergoing cardiac resynchronization therapy (CRT). SCREENING – Cardiovascular Risks (Annex 2) Detecting pathological cells before they spread - PET/CT and Molecular Imaging Looking at the most promising prospects of earlier detection of Cardiovascular Disease (CVD) one quickly steps over the “hybrid” of anatomical information (volumetric CT) and functional information (PET), both combined in one equipment (PET/CT).
CT
PET/C T
PET
Functionecificity Comprehensive and sensitivity approach to CAD • Perfusion and viability Diagnosis The most promising molecular cardiovascular applications of information PET in the near Anatomy my & coronary vasculature • Calcium scores
future include: strategic targeting of biologic feature of vulnerable atherosclerotic lesions, specific monitoring of novel interventions such as gene and cell therapy identification of specific pathobiologic alterations within myocardial tissue such as apoptosis and angiogenesis and extracellular matrix activations Many of theses applications will greatly benefit from the use of integrated PET/CT due to its precise spatial and morphological assignment of functional 31
information. PET is both capable and necessary for the transference of new biological knowledge to clinical practice. The future potential of Molecular Imaging (MI) Being more visionary in a second step leads to the idea of Molecular Imaging which is basically the ability to visualize and monitor processes on a cell level which may provide information about existing defects or the transformation towards pathology. This way technology enables the detection of small numbers of cells that are at the early stages of disease, the signal given off by the agent is relatively weak and it is like detecting a needle in a haystack. However, the new advances in the research of the human genome are leading to the discovery of early disease indicators, often called biomarkers, and the translation of this knowledge to aspects of disease expression inside the body (in vivo), are exciting aspects of Molecular Imaging. Imaging agents that look at the ability of cells to grow (or proliferate), die (widely known as apoptosis or programmed cell death), or to form new blood vessels (such as angiogenesis) are part of the untapped future potentials of molecular imaging. The stethoscope of the future - Portable ultrasound
Miniaturization of portable ultrasound systems for real-time imaging at the point of care places the power of ultrasound technology within the reach of even more physicians. Comprehensive cardiac measurement and analysis packages and also fullshared service capabilities, which in the past required huge machines of more than 100kg, are today housed in a portable 5kg unit.
This way ultrasound helps to address some of today‟s most pressing healthcare issues such as improving access to quality care in rural communities and developing regions of the world, and in developed regions, shifting to an „early health‟ model where technologies such as ultrasound can be used to help detect diseases earlier when they can be more effectively treated.
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An example for the early detection of coronary artery disease (CAD), which accounts for more than 60% of all CVD, is the screening of the carotid vessel and its intima media wall thickness (IMT). The degree of calcification of the intima media wall serves as a good indicator for the atherosclerotic risk of the coronaries.
A view from the inside - Platform integration with invasive device technology The leverage of miniaturized ultrasound probes, sitting at the tip of a catheter (Intra-cardiac echo, ICE) for a direct view into the chambers has just started and holds huge promises towards improved placement of RF leads for ablation therapy in the right atrium as well as ventricular assessment in heart failure patients. For interventional procedures intravascular ultrasound (IVUS) has already undergone intensive development over the past years and latest technologies allow for “virtual histology” assessment of plaque and lesions inside the coronaric vessels as well as judgement on stent deployment from an “inside” perspective.
ICE catheter
1. Flexible drive shaft 2. Single Large Aperture 9MHz Transducer 3. Clear Acoustic Window
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SCREENING – CANCER (Annex 3)
Introduction: A brief statement on MR Breast Imaging strength. MR has a High sensitivity but a lower specificity. Conventional mammography remains the primary diagnostic tool for breast cancer. It offers morphology information of the lesions and detects the presence of micro calcifications, an important sign for detecting breast cancer. Mammography limitation being a reduced sensitivity in dense breast. Breast MR has already been widely accepted as a very sensitive technique in the detection of infiltrating carcinoma, with a sensitivity ranking from 94% to 100%. However, no similar consensus occurred on specificity figures. Specificity of breast MR was ranked from 37% to 98%. Obviously, this extremely wide range took place because of the difference in MR acquisition and processing techniques used by people from different institutions. MR Breast Imaging: current indications. If some technical controversies persist, there is already strong scientific evidence of the clinical relevance of Breast MR in detecting invasive cancer. Some clinical indications of breast MR are nowadays well established: Preoperative Breast cancer staging , Discrimination between fibrosis and recurrent cancer, Some recent publications clearly suggest that breast MR in combination with mammography is the technique of choice for screening of high risks patients such as the ones with proven BRCA1 & BRCA2 genetic mutation. MR Breast Imaging: Morphology and Kinetics assessment of both breasts. MR imaging enables both High Contrast Assessment, relatively High Resolution Imaging as well as Dynamic Contrast Enhanced imaging (DCE) where breast cancer tissues demonstrate a greater signal enhancement than normal fibroglandular that thus allows wash-in / wash-out analysis. Different enhancement patterns in DCE have been described. In the vast majority of cancers, a rapid enhancement during the first minute after contrast injection is usually followed by a peak enhancement in the second minute that then exhibit a plateau or a washout. A good Morphology should exhibit the higher spatial resolution possible. A good kinetic analysis is characterise by a one minute temporal resolution during six minutes after contrast injection.
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MR Breast Imaging: Pre-requisites A Dedicated Coil. Along with the technical pre-requisites described in the previous paragraph, the necessity of image–guided wire localization or core biopsy of suspicious lesions is emphasizing the need for dedicated coils allowing full organ coverage as well as axillary coverage. Accreditation process will more and more emphasize this need. Custom made solutions does not provide enough patient positioning repeatability and Image Quality. A Dedicated Acquisition Package. Sequence optimization necessity also requires a specific package to achieve whole organ coverage compatible with kinetics characteristics. A Dedicated Post Processing Package. The large amount of data to process has lead to the development of software tools to ease the different steps of data processing. These tools permit the construction of coloured maps that allow to analyze at first glance normal and suspicious tissues behaviour.
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CONCLUSIONS
Partnership in the Interest of People New and existing Member States are directing their health policies to subscribe increasingly to the paradigm of citizen-centred and patient-centred services. This implies several activities that are: to support the need to improve patient safety along the full continuum of care; support healthcare professionals in their daily work and provide citizens with tools that enable them to become both well-informed and self-assured patients and, gather, analyse and disseminate relevant quality information for policymaking.
The examples above have shown, that innovation in medicine and medical, information and communication technologies technology can improve the different stages of the care process. Prevention, screening, diagnosis and therapy can be less burdensome to the citizen-patient, reach a higher level of quality and can be made more cost-efficient. This can be achieved through avoidance of errors and medical complications, easier examinations and therapies, easier access and sharing of information and less unnecessary procedures. Also, the locations in which health care is provided are constantly changing. Developments in medical, communication and information technologies allow selected services, previously provided only in hospitals, to be offered in community clinics, mobile health units and in patients‟ own homes. However, to achieve this vision, health, social care and other providers must no longer work in isolation, but need to collaborate as a team into a coherent continuum of care process, if necessary beyond their national and linguistic borders − medical, information and communication technologies again can facilitate this co-operation. It is indeed vital that these parties can have access to and share securely up-to-date information on a citizen‟s health status, data which they can understand and act on. all stakeholders in health care need to work together in order to combine all these individual procedures into a coherent care process of high quality and efficiency. The medical industry will contribute its technologies, and its experience and skills to this health care transformation process. Information technology and the Electronic Health Record (EHR), making all relevant health data available when and where needed, will play an essential role. Only well informed patients and medical professionals can take the right decisions in critical situations. In addition to that the diagnostic and therapeutic tools need to be available to implement these decisions. Transparency about the results from prevention and screening programs as well as different treatment paths will help to improve the process continuously.
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Industry and medical professionals have already started to optimise processes and the use of technology in dedicated areas. The initiative “Integrating the Health Care Enterprise” (IHE) is developing integration profiles that address eHealth interoperability problems across different standards, technologies and manufacturers. IHE describes and tests solutions for specific clinical situations in various departments of health care enterprises, e.g. clinical laboratories, cardiology or radiology departments. The relevant clinical processes are being defined by medical professionals and are being detailed and implemented by industry. The initiative is successful and addressing more and more clinical processes in a pragmatic way, that brings short term gains to medical professionals. The example of IHE shows, that the definition of sensible processes has to be done by stakeholders involved in the issue at hand. Only this will guarantee tangible improvements quickly. If systems are not interoperable from country to country, this would be more costly to deploy and maintain and bring an extra burden on healthcare while already at flex point.
To sum up, Aa health care system centredcentered on the citizenpatient and build on efficient processeshigh-quality health systems, services and processes can only be achieved, if all stakeholders jointly work for this goal: citizens, medical professionals, health insurances, industry and politicians and, at the same time, the industry. Health is the most important good for people, but health care is also an increasingly important sector of most economies. This combination is both the source and the driver for innovation. Health is therefore not a cost-saving action, health is an investment, not an expenditure.
Whether near or longer term, what is certain is that health modernisation starts “TODAY”. It requires immediate actions and longer term medical, information and communication technologies‟ scenarios to enable the change process. While new
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technologies are an enabler, it is not a driver and not a solver. It would not replace the need for political “will” and sustained investment. The prime onus is therefore on Governments to set the pace and bring together the agents of transformation in partnerships with the health stakeholders and the industry, and in the interest of people. Acknowledgement The following members of COCIR have contributed to the development of this brochure: AGFA -Gevaert Dräger Medical GE Healthcare KODAK Philips Medical Systems Siemens Medical Solutions Toshiba Medical Systems Europe COCIR Secretariat General Stresemannallee 19 60596 Frankfurt / Main phone: +49 69 6302 206 fax: +49 69 6302 390 e-mail: office@cocir.org “Back site” COCIR – European Coordination Committee of the Radiological, Electromedical and Medical IT Industries Bd. A. Reyerslaan 80 1030 Brussels Belgium www.cocir.org
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