V O L 3 0 I S S U E 1 / 2 1 M a r c h / A p r i l 2 0 2 1 T H E E U R O P E A N F O R U M F O R T H O S E I N T H E B U S I N E S S O F M A K I N G H E A L T H C A R E W O R K EH @ ECR 2021 6-14 AI boosts digital radiography QuADRANT project defines audit Managing cancer-questionable breast lesions LABORATORY 4-5 Better detection and diagnosis of fungal infections Covid-19: Overcoming unprecedented challenges The Chaimeleon project A new EU-wide repository for health-related imaging data could boost development and marketing of AI tools for better cancer management. The open-source database will collect and harmonise images acquired from 40,000 patients, spanning different countries, modalities and equipment. This approach could elimi- nate one of the major bottlenecks in the clinical adoption of AI today: Data bias. Report: Mélisande Rouger The project, named ‘Chaimeleon’, has been injected with €9 million from the European Commission to create a homogeneous dataset, by 2024, to predict tumour behaviour with the help of AI. Eighteen partner institutions and external providers will select and analyse images that have been acquired at different European sites in patients who have and will be diagnosed with breast, colorectal, lung and prostate cancer between 2015 and 2024. The researchers will design a multimodal analytical data engine to facilitate the interpretation and extraction of the relevant informa- tion stored in the database. Leading developers will validate applicabil- ity and performance for AI experi- mentation, and the selected tools will undergo early validation in observational clinical studies. Harmonising images of 40,000 patients A key step of the project is to har- monise images. This enables the algorithms to obtain relevant data from them which will help clinical practice. The developers are confi- dent that this will help overcome data heterogeneity, one of the main obstacles to the wider use of imag- ing biomarkers. After harmonisa- tion, image features can be corre- lated to other biological findings to track changes produced by a lesion or a drug treatment, according to Chaimeleon coordinator, Dr Luis M a r t í - B o n m a t í , director of the medical imag- ing department at La Fe Hospital in Valencia, Spain. ‘We want to be able to predict tumour behaviour using images regardless of the equipment, protocol or version used for their acquisition,’ he said. ‘Reducing vari- ation between imaging studies is critical for AI to have a real impact.’ Images obtained from different hospitals or even different depart- ments within the same hospital will always produce heterogene- ous results. Variations in imaging equipment and constantly evolving technologies make it near-impossi- ble to reliably generate comparable images in clinical practice, even when following the same imaging protocols. However, working with heterogeneous images may compro- mise data impartiality in the quanti- fication phase. ‘When images come from different centres and scanners, you run the risk of working with biased data,’ Marti-Bonmatí said. Because of its wide scope, the data repository should be applicable to other forms of cancer across the EU. Selecting relevant use cases Chaimeleon will tackle regulatory, technical and ethical issues, and then include pertinent clinical use cases. Dr Laure Fournier, profes- sor of radiology at the Georges Pompidou European Hospital and Paris University in France, is in charge of develop- ing the scientific content, under the aegis of Dr Jean- Paul Beregi The Chaimeleon project map shows locations of centres involved in the project www.healthcare-in-europe.com Dr Laure Fournier is professor of radiol- ogy at the Georges Pompidou European Hospital and the Université de Paris, France. Her time is divided between clinical work on urogenital cancers and imaging research in the INSERM U970 imaging research lab. She works on functional imaging, radiom- ics and big data, to extract quantitative parameters from images reflecting tumour physiology and biology, more specifically to define response to therapy. She organises the curriculum on AI for French radiology residents and is a member of the scientific committee of the DRIM France AI national image database and the medical imag- ing chair in the PRAIRIE interdisciplinary AI institute. to trade-offs: ‘The more relevant data you collect, the fewer patients you have.’ The selected imaging data must also add value to existing clinical practice, for example PSA in prostate cancer, she pointed out. Pioneering new combinations to explain AI The Chaimeleon repository will also be an opportunity to test combina- tions of advanced computational techniques, in order to make AI more understandable. Researchers will evaluate the combination of self-supervised learning and Generative Adversarial Networks (GANs) to enhance reproducibility of radiomics features and param- eters extracted from cross-vendor and cross-institution CT-MR-PET/ MR imaging data. The effort will be led by the Imperial College of Science Technology Medicine in London, UK, with GE Healthcare and Quibim, a medtech company that extracts imaging biomarkers from radiology images. ‘Our goal is to demonstrate that this combination is possible to reduce the bias in quan- tification, by building models that are more explainable,’ explained Angel Alberich-Bayarri, CEO and co-founder at Quibim. ‘Think of an iPad – you never give the instruction manual to a kid, they learn by inter- acting with the tool. In self-super- Dr Ángel Alberich-Bayarri is CEO and co-founder of Quibim, a medtech company based in Valencia, Spain. With a PhD in biomedical engineering, he served as sci- entific-technical director of the biomedical imaging research group (GIBI230) and as a board member of the European Society of Medical Imaging Informatics (EUSOMII) and the European Imaging Biomarkers Alliance (EIBALL). He has more than ten years’ experience in the development of quantitative image analysis solutions and their integration in clinical practice. He has co-authored more than 60 research papers and has participated in numerous interna- tional research projects in medical imaging. and the French radiology teachers association (CERF). ‘From image acquisition to imaging biomarkers reporting, the project is focused on inciting AI research,’ she said. ‘Everything has to be built from scratch; that’s one of the most inter- esting aspects of the project.’ Once the database is structured, researchers will have to feed it and decide what kind of images and data they want to put in. Their aim is to find a model that is viable across the EU. Criteria for inclu- sion in the dataset will be defined according to the clinical question - for example, to predict response to immunotherapy in lung cancer. This determines which kind of images should be sorted out and which type of biological and clini- cal data can help provide relevant information. Although harmonisation is a huge challenge, diversity of data is para- mount to avoid being too specific. ‘It’s very important that the images come from different sites, equip- ment and acquisition methods, with different slice thicknesses, etc.,’ Fournier explained. To achieve this, a proper balance between quantity and feasibility must be found - which inevitably leads Dr Luis Martí-Bonmatí is professor and chairman of radiology and direc- tor of the medical imaging department at La Fe University and Polytechnic Hospital, Valencia. He is a full member of the Spanish Royal National Academy of Medicine representing radiology and was founder and director of the research group on biomedical imaging (GIBI230) within La Fe Health Research Institute. He has presided over the European Society of Magnetic Resonance in Medicine and Biology (ESMRMB), Spanish Society of Radiology (SERAM), Spanish Society of Abdominal Radiology (SEDIA) and European Society of Gastrointestinal and Abdominal Radiology (ESGAR). vised learning, you interact with the data to find patterns within.’ Thus the researchers want to explore the use of self-supervised learning as a paradigm shift in AI, where models are autonomous- ly developed without the need of annotated data. In self-supervised schemes, part of the data contained in the images is withheld during the training process. This way, the algo- rithm learns to predict hidden parts from the knowledge acquired from complete images. The project will also build on tools that have been validated for image harmonisation of multi-ven- dor or multicentric data and inter- pretability of AI. Quibim will notably use its expe- rience in building the cloud-based platform of another EU project called PRIMAGE, which gathers thousands of paediatric oncology cases by inte- grating hospitals’ repositories from all across Europe. www.healthcare-in-europe.com CONTENTS 2-3 ONCOLOGY 4-5 LABORATORY EH @ ECR 6-14 DIGITAL PATHOLOGY 15-16
2 O N C O LO G Y What EU/UK deals may mean Post-Brexit and future cancer research Creating robust scientif Mark Nicholls reports on an online experts debate focused on how Brexit could affect research Despite Brexit uncertainties, four leading UK cancer research experts expressed optimism for continued pan-Europe- an collaboration and innovation dur- ing the online panel debate ‘Brexit deal: What it really means for cancer research and innovation’ hosted by the National Cancer Research Institute (NCRI). The experts, Dr Sheuli Porkess, Professor Richard Sullivan, Emlyn Samuel, and Jim Elliott, were chaired by Professor Pam Kearns, Chair of Clinical Paediatric Oncology at the University of Birmingham. Steep challenges Having reviewed the current UK research and innovation landscape, the panellists discussed the outlook from the perspective of key UK organ- isations. Also considered was the potential impact of the coronavirus pandemic on cancer research, science, innovation, funding and treatment in the future, and also the long-term economic effect of Covid-19 interna- tionally. Porkess noted that Brexit and the pandemic had brought disruption to global R&D and healthcare systems, but had motivated the Association of the Britisch Pharmaceutical Industry (ABPI) to be even more focused on being internationally competitive with commercial clinical trials. Concerns include continued partici- pation in EU programmes, data ade- quacy, clinical trial supplies, moving products for research and additional hurdles for equipment and consuma- bles imports, regulation of trials, and immigration factors. ‘It’s tough at the moment with the effects of Covid-19 and we also know some practicali- ties of Brexit have not been worked through,’ Porkess said. ‘But, we have a recovery resilience and growth pro- gramme in place that gives us oppor- tunities we’ve not had before to get through those changes, to ensure Research in a laboratory recovery from the pandemic and drive that growth in research that we all want to see.’ The Cancer Research UK (CRUK) has worked with the UK government, and across Europe, on the implica- tions of Brexit since the 2016 referen- dum to ensure, whatever the outcome, that ‘cancer patients and research is protected as far as possible’, Samuel pointed out. Continuity across borders Key topics were the regulatory envi- ronment for clinical trials, immigration and movement, as almost a third of CRUK trials involve patients from EU member states. ‘We’ve also been working to ensure that patients can continue to access new and innovative medicines as well as the supply of existing medicine across borders, and also working on monitoring broader research envi- ronment with the Horizon Europe Association – one of the real posi- tives to come out of the deal,’ Samuel added. ‘There was a huge relief that there was a deal; it provides a plat- form for further development and negotiation of the UK relationship with the EU.’ Sullivan said his team had examined the effect of Brexit on cancer research with regards to the socio-economic impact; the mechanistic aspects of collaboration and partnership, such as policy changes around the ability for people to move freely across borders; and the political attitude to collabora- tions. While the UK had previously enjoyed an enormous amount of EU funding, he feared it now risked no longer being centre stage in major initiatives. Elliott commented that it still remained difficult to see clearly what the issues may be because of the pan- demic, but added: ‘The characteristic of the cancer patient movement is a “can-do” attitude, so I’m reasonably confident that the UK research com- K U R C : t h g i r y p o C Professor Pam Kearns is Chair of Clinical Paediatric Oncology at the University of Birmingham, an Honorary Consultant Paediatric Oncologist at Birmingham Women and Children’s Hospital, and Director of the University of Birmingham’s Institute of Cancer and Genomic Sciences and Director of the Cancer Research UK Clinical Trials Unit (CRCTU). Emlyn Samuel leads the policy depart- ment at Cancer Research UK and a team of policy, public affairs and campaigning experts who work to drive policy change up to international levels. Jim Elliott is a member of the National Cancer Research Institute (NCRI) Consumer Forum and is part of the NCRI Consumer Involvement Advisory Group. munity will find ways to carry on and collaborate across Europe, as we do in the rest of the world.’ A new relationship Pre-Brexit free movement, ‘a sig- nificant enabler of collaboration’, has gone, causing Elliott concern over paediatric oncology and rarer cancers, and the possibility that UK patients may not be eligible to take part in trials being run in the EU. He warned of continuing uncertainty as a new relationship is developed with the EU on immigration and regula- tory status ‘…and how we will con- tinue to partner with the EU on clini- cal trials and research going forward’. Discussion flowed on. Question: Might the UK, being outside the European Medicines Agency (EMA), offer speedier approval of drugs and therapies from the Medical and Healthcare products Regulatory Agency (MHRA), making it an attrac- tive test bed for innovation? Sullivan said the new Horizon Europe programme remains impor- tant, with the Erasmus programme no longer accessible to the UK and replaced by a ‘global talent visa’, with concerns that movement between the UK and Europe for research would become more complex and costly. How will Brexit affect funding that enables cross border research? While Covid has impacted on charitable income, the panel felt UK participation in the Horizon Europe research and innovation framework programme was important. ‘The UK has some of the best early phase clinical trial activ- ity, not just in Europe but probably in the world,’ Sullivan said, pointing out the UK’s ‘amazing infrastructure for Pharmaceutical physician Dr Sheuli Porkess is Interim Medical Director at the British Pharmaceutical Industry Association. She began her career in the NHS and has held numerous medical leadership roles in companies at a nation- al, regional and international level. Richard Sullivan is Professor of Cancer and Global Health at King’s College London, Director of the Institute of Cancer Policy, and co-Director of the Conflict and Health Research Group. clinical research’ to run complex trials. Data protection and exchange of personal data with GDPR regula- tions is still an issue, but confidence remains over an agreement on data adequacy for data flow. CRUK funds 30% of research fellows, and 43% of post-doctoral researchers from the European Economic Area (EEA) who will hopefully be able to ‘work around Brexit’. On the upside, the Brexit deal provides 90-day visa-free visits. In conclusion, Kearns questioned the panel’s optimism about post-Brex- it cancer research. Porkess is optimis- tic about UK-EU research collabora- tions, and Sullivan believes research relationships built up over years will remain strong. Elliott added that patient anxiety could be eased with good communication and engage- ment, while Samuel feels positive about conversations over ‘moves to bolster’ the UK’s life sciences and clini- cal trial environment. n a e l c M k i r E / h s a l p s n U : e c r u o s e g a m I Due to compromised immune systems, cancer patients are at higher risk of contracting infec- tions. How does cancer impact on patients who also contract Covid-19? To collect this data, four cancer registries, one in the EU, one in the UK, two in the USA, have been established. Report: Cynthia E. Keen The first large, multi-institution study of the impact of Covid-19 was conducted in Wuhan, China, and presented at the virtual American Association for Cancer Research (AACR) Annual Meeting 2020 in April. The study included 105 can- cer patients and 536 age-matched patients without cancer, and showed that Covid-19 patients with cancer had higher risk in intensive care unit (ICU) admissions and mortality. However, at the same conference, researchers from Gustave Roussy Cancer Campus in Villejuif, France, reported that 137 cancer patients diagnosed with the coronavirus in March did not have more lethal or aggressive disease than patients without cancer in the global popu- lation. Such conflicting reports sup- ported the urgent need to acquire long-term global data. The UK Coronavirus Cancer Monitoring Project The UK Coronavirus Cancer Monitoring Project (UKCCMP) (www.ukcoronaviruscancermonitor- ing.com), established in mid-March 2020, was the first Covid-19 clinical registry to enable near real-time reports to frontline physicians about the effects of Covid-19 on cancer patients. Its objective is to monitor the impact of Covid-19 and enable oncologists to gain crucial insights and inform clinical- and infrastruc- ture-based decision making. A live clinical data dissemination system provides a daily update to an inter- active website; weekly reports are sent to individual UK cancer centres and clinicians. In its first five weeks EUROPEAN HOSPITAL Vol 30 Issue 1/21
O N C O LO G Y 3 The importance of Covid-19 registries for cancer patients from Canada, USA and Spain who received treatment for Covid-19 between 17 March and 16 April 2020. The study’s primary end- point was all-cause mortality with- in 30 days of Covid-19 diagnosis. This is an ongoing clinical trial (NCT04354701) with an accrual goal of 10,000 patients. Patients ranged in age from 18 to 90 years, with a median age of 66. The cohort had 20 different types of cancer in all stages, with 32% stable or responding to treatment, and 45% in remission or presumed cured. Three percent had surgical treat- ment within 30 days of contracting Covid-19, and 39% had received anticancer treatment in this time frame. The majority had two or more comorbidities; 51% had no smok- ing history. Thirteen percent died from Covid-19 within 30 days of contracting it. This highly detailed, early report suggested that cancer patients appear to be at increased risk of mortality and severe illness. The treatment utilisation study included 2,186 adults, with a median age of 67, of whom 47% had mild, 40% moderate, and 12% severe base- line Covid-19 severity. Patient demo- graphic and cancer characteristics, Covid-19 treatments received, and outcomes are discussed in detail. Sixteen percent died from Covid- 19 within 30 days of contracting it, again reinforcing the vulnerability of cancer patients to the novel coro- navirus. ASCO Covid-19 and Cancer Registry The American Society of Clinical Oncology (ASCO) launched the ASCO Survey on Covid-19 in Oncology Registry (www.asco.org/ asco-coronavirus-information/coro- navirus-registry) in early April, invit- ing oncology practices across the USA to share information about patients. ASCO established this reg- istry to collect both baseline and Richard L Schilsky MD is executive vice- president and chief medical officer of the American Society of Clinical Oncology (ASCO). Leonard Y W Lee MD PhD is an honorary research fellow of the Institute of Cancer and Genomic Studies of University Hospitals Birmingham and executive lead of the UK Coronavirus Cancer Monitoring Project. longitudinal data on how the virus impacts on cancer care and can- cer patient outcomes during the Covid-19 pandemic and into 2021. Data being collected includes char- acteristics of cancer patients most impacted by Covid-19, estimates of disease severity, treatment modifica- tions or delays, implementation of telemedicine in the cancer treatment setting and clinical outcomes related to both Covid-19 and cancer. Richard L Schilsky MD, ASCO executive vice president and chief medical officer, explained that whilst the ASCO Registry and CCC19 Registry have very similar objectives, the ASCO Registry col- lects more information on cancer treatment and outcomes, whereas CCC19 collects more data on Covid- 19 treatments. Data is also updated on different schedules, with ASCO requesting that practices update their patients’ Covid-19 status on a weekly basis and cancer status on a monthly basis. CCC19 is requesting 30- and 90-day outcomes. ‘As of mid-August, 45 oncology practices and cancer treatment cen- tres have submitted data about 300 patients with 33 different types of cancer,’ Schilsky said. ‘ASCO is inter- ested in collaborating with other Covid-19 and cancer registries to extend our findings and maximise our learning from data collection on the impact of Covid-19 on people with cancer.’ ESMO-CoCARE Registry Launched on 29 April, this registry provides Covid-19 data to cancer centres and organisations interna- tionally (but not North America). With the most diverse geographic enrolment in the world, it is led by a steering committee of nine oncol- ogy experts from France, Germany, Portugal, Switzerland, the UK and the USA. As of mid-August, partici- pation of cancer treatment centres was 111 – Europe, 23 – Middle East; 8 –Africa; 48 – Asia, and five – Oceania. To increase global data collection ESMO Co-Care also part- nered with the CCC19 Consortium, which covers North America, The Registry’s demographic data includes age, sex, place of residence, ethnicity, and nationality. Clinical history data includes prevalence of major comorbidities and the param- eters defining a patient’s malignan- cy, including histology, stage, organ dysfunction, and molecular features. Antineoplastic therapies admin- istered within two months from Covid-19 infection, including chem- otherapy, immune check point inhibitors and targeted therapies, surgery, and radiotherapy are being recorded. Creating robust scientific tools regular rapid Covid-19 testing, espe- cially prior to each cycle of chemo- therapy. Oncologists need to take decisive and active steps, such as screening regularly for Covid-19, to prevent infection while administer- ing effective anti-cancer treatments for patients who have a rapidly pro- gressive tumour.’ The Covid-19 and Cancer Consortium (CCC19) The Covid-19 and Cancer Consortium (CCC19) (www.ccc19.org), also established in mid-March, is collect- ing data to study the characteristics and course of illness among patients age 18 and older diagnosed with Covid-19 and a current or past diag- nosis of invasive solid or haemato- logic malignancy. Currently, 120 institutions are participating, of which 11 are locat- ed outside the USA. The 11-mem- ber steering committee includes Professor Solange Peters MD PhD, head of the Medical Oncology Service of the University Hospital Lausanne, and the current president of the European Society for Medical Oncology (ESMO). CCC19 is actively analysing and reporting findings from its registry, including a cohort study on the clin- ical impact of Covid-19, published open access in The Lancet (28 May 2020), and a study on the utilization of Covid-19 treatments and clinical outcomes among cancer patients, published open access (22 July) in Cancer Discovery. The clinical impact study includ- ed 928 invasive cancer patients The Covid-19 map. of operation, the UKCCMP accrued the largest prospective database of symptomatic and asymptomatic Covid-19 cancer patients globally. Approximately 80% of UK adult and 100% of paediatric cancer treatment centres are currently participating. As of mid-August, the cases of 2,314 adult and 61 paediatric can- cer patients were enrolled in the database. ‘Our objective is to identify and learn from every case of Covid-19 in cancer patients in the UK,’ said Leonard Y W Lee MD PhD., an hon- orary research fellow of the Institute of Cancer and Genomic Studies of University Hospitals Birmingham and an executive lead of the project. ‘The number of cancer patients with Covid-19 in the UK is relatively small. But approximately 2.5 million individuals live with or have a his- tory of cancer in the UK, with an estimated 1,000 new diagnoses each day. A substantial number of new cases require, are undergoing, or are recovering from surgery and com- plex treatments. One of the things we want to determine is if specific cancer treatments may differentially contribute to the risk of developing Covid-19.’ In results of a Covid-19 mortal- ity study* of 800 cancer patients who contracted Covid-19 between 18 March and 25 April revealed that patients receiving or who had received chemotherapy and/or radi- otherapy within the past 30 days were not at greater risk of dying when compared with other can- cer patients. (*Conducted by the UKCCMP project team and pub- lished in The Lancet 20/6/2020). However, age and comorbidities were significantly associated with Covid-19 related death of 28% of these patients, the researchers reported. ‘We also determined that can- cer patients were at increased risk from Covid-19,’ Lee told European Hospital. ‘Globally, a mortality rate of 20-35% is being reported. 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4 L A B O R AT O RY Wako ß-glucan test Better detection and diagnosis of fungal infections Beta-glucan tests are proving to be pivotal in the better detection and diagnosis of fungal infections. As a robust compli- mentary test for traditional testing techniques and biomarkers, it is helping clinicians deliver rapid results and offering greater reassurance in more accurately identifying such infections. ß-glucan testing, which is an in vitro diagnostic test, is regularly used at University Hospitals Leuven in Belgium. ‘Although it is not a specific test for a particular fungal disease, the value is its use in conjunction with other conventional tests, such as microscopy and culture, and biomarker detections,’ explained Professor Katrien Lagrou, head of the Molecular Diagnostics department at the university. Report: Mark Nicholls fungal diseases are a Invasive major worldwide health problem and affect immunocompromised patients, such as those undergoing intensive-care treatment, and people with chronic disorders – particu- larly lung diseases. Most infections are caused by Aspergillus, Candida and Pneumocystis jirovecii, with early recognition and diagnosis cru- cial to improve patient outcomes. Guidelines the European Confederation of Medical Mycology for Candida – which will be updated imminently – and Aspergillosis, rec- ommend the use of a ß-glucan test for their detection. from In addition, PCR (polymerase chain reaction) is the first line test in non-HIV Pneumocystis jirovecii Pneumonia but it has drawbacks that the ß-glucan test can help overcome. ‘It’s not always possible to have a bronchoalveolar fluid sample to perform a PCR test and Toxinometer MT-6500 system by FUJIFILM Wako Chemicals Europe GmbH for the kinetic turbidimetric measurement of ß-D-glucan have their own value and they do provide complimentary information, and the ß-glucan test is one of those tests.’ The Wako ß-glucan test – evalu- ated at the Leuven centre – is an in vitro diagnostic test for the quantitative determination of (1 3)-ß-D-glucan in serum or plasma and a marker of invasive fungal infections. The assay is performed on the Toxinometer MT-6500 device developed by FUJIFILM Wako Pure Chemical Corporation. The test may also have a role with Covid-19, where invasive aspergil- losis is a complication in Covid patients and also a known compli- cation with influenza patients. But, Lagrou added, ‘The diagnosis with Covid patients is not easy and it’s good to combine different tests. These patients might also have an invasive Candida infection, especial- ly among those in the ICU. As yet, we are in the learning phase about the incidence, disease characteris- tics, and still evaluating these tests. It is too early to say what the exact value of the ß-glucan test is in this instance.’ However, there are aspects of the Wako ß-glucan test that make it an appealing option for clinicians. The single sample test: a real advantage ‘One of the things that appeal is the fact that you can run it as a single sample test,’ Lagrou said. ‘That’s a real advantage because we are in a setting of several life-threatening infections where it is important to Professor Katrien Lagrou is Head of the Department of Microbiology, Immunology and Transplantation at the University of Leuven and also heads the National Reference Centre for Mycosis. She is also Professor at the Faculty of Medicine of the Catholic University of Leuven. Her major interest is the diagnosis of fungal and viral infections in severely immunocompromised patients, with a focus on invasive pulmo- nary aspergillosis. Lagrou also presides over the Belgian Society of Human and Animal Mycology and is former General Secretary of the European Confederation of Medical Mycology. get the information as soon as pos- sible and to be able to put together the results of different tests we are conducting. It’s also a robust test and the reproducibility is very high.’ Other advantages, she pointed out, are that the test adds additional information, is not difficult to imple- ment or execute, and staff can be trained to use it relatively easily, and it also delivers rapid results with clear benefits for prompt patient care. Lagrou believes there will be future areas where the Wako ß-glu- can test can be of value and this will evolve as the sensitivity can be improved by lowering the cut-off value, with high sensitivity of par- ticular importance when diagnosing invasive fungal infections. Patients with an impaired immune system are at risk of invasive fungal infections we also know the PCR test is super- sensitive and may detect colonisa- tion and not infection, said Lagrou, who also heads the Department of Microbiology, Immunology and Transplantation and also heads the National Reference Centre for Mycosis at University Hospitals of Leuven. ‘If it’s not possible to conduct bronchoalveolar lavage, the ß-glu- can test may be used to evaluate the likeness of Pneumocystis infection. In addition, this test may also be of value in the discrimination between infection and colonisation.’ What it offers as a complimentary test, she added, is an extra level of reassur- ance – either to support a diagnosis or exclude the diagnosis. In vitro diagnostic test ‘The diagnosis of fungal infection is complicated and you need to put together different tests and they all Stabilisation from the start Precise glucose testing Diabetes mellitus is one of the most common metabolic disorders in the world, and plasma glucose levels are essential for its evaluation, as well as gestational diabetes. The breakdown of glucose (glycolysis) in venous blood samples is of great significance in pre-analytics, par- ticularly in relation to the diagnosis of diabetes mellitus and gestational diabetes. Effective glycolysis inhibition: determining in vivo blood sugar content precisely with the Vacuette FC Mix Tube Greiner Bio-One produces the Vacuette FC Mix Tube. This special additive mixture not only reduces the pH value and blocks the pH- dependent enzymes which would be active in the initial stage of the glycolysis cascade. The tube can also stabilise the sample immediate- ly after collection for up to 48 hours. The time from collection until separation of plasma and cells, temperature as well as cell count strongly affect glucose levels, pos- sibly leading to false low results. Unfortunately, fluoride alone cannot stabilise the real in-vivo glucose level completely. Vacuette FC Mix Tubes are citrat- ed and therefore can help to prevent the initial loss of glucose within the first few hours from collection until fluoride shows its effect. Buffered Na2EDTA, citric acid, sodium citrate and sodium fluo- ride are used to decrease the pH and block the pH depend- ent enzymes, which would be active in the ini- tial stage of the glycolysis cascade. The shatter-proof tube is made of polyethylene terephthalate (PET). PET is important for the stability of the vacuum, Greiner Bio-One points out, adding that the safety cap is particularly easy to open and facilitates hygienic working. The transparent plastic label provides an optimum view of the tube contents. Powder additive ‘The powder additive in the Vacuette FC Mix Tube has no dilution effect. There is no need to take a con- version factor into consideration. Inverting ten times ensures that the tube additive is completely dis- solved and well mixed with the sample. than ‘Should the stored tubes be longer 24 hours at room tem- perature, samples should be centrifuged after blood collection. Centrifuged aliquots from FC Mix Tubes can be stored for up to 48 hours at room tempera- ture. Tubes should be centrifuged within 20 minutes after blood col- lection. Cooling of the samples is also suitable for 48 hours glucose stabilisation.’ Details: www.gbo.com EUROPEAN HOSPITAL Vol 30 Issue 1/21
L A B O R AT O RY 5 Optimising clinical laboratory management in a pandemic Covid-19: Overcoming unprecedented challenges During a pandemic, the demands for laboratory testing challenge routines in an efficiently run clinical laboratory. Gold standard procedures may need modification, or to be discarded, and the more nimble, resilient and receptive a lab is to change, the better off it could be. r a t s k a e l b / k c o t s r e t t u h S : e c r u o S Report: Cynthia E. Keen Senior managers at ARUP Laboratories in Salt Lake City, Utah, a large clini- cal reference laboratory that offers over 3,000 diagnostic tests and test combinations to client laboratories throughout the USA, describe how they coped with ‘unprecedented challenges in a world turned upside down’ during the first six months of the Covid-19 pandemic, in their article in the January 2021 issue of the American Journal of Clinical Pathology. Communication and collaboration Communication and collaboration are the primary means of creating and maintaining a flexible, resil- ient organisational structure, explain chief operating officer Jonathan R Genzen MD PhD, and Brian R Jackson MD, medical director of support services, IT and business. Before the pandemic struck, ARUP management prided itself on enforc- ing essential-only meetings and e-mail messaging policy to main- taining good communications with- out sacrificing workforce efficiency. In-person department and medi- cal directors’ meetings were held monthly. However, from March 2020 in- person meetings were cancelled, to be replaced with virtual meetings held once weekly to convey news and information and more rapidly deal with and implement necessary operational and policy changes. The underpinning of all initiatives was decision-making collaboration across teams, departments, and divisions. ‘Laboratory operations, R&D, supply chain, finance, human resources, business development, IT, safety, and facilities all have an essential role in this coordinated response. Each is affected by how the laboratory should respond to the crisis, and conflicting depart- www.healthcare-in-europe.com During a pandemic, laboratories need to cope with unprecedented challenges and must therefore change their workflows mental priorities can hinder the ability to successfully implement initiatives in a timely manner,’ the authors wrote. ‘Collaboration facili- tated effective conflict resolution.’ Also in March, ARUP’s chief exec- utive officer, Sherrie L Perkins MD PhD, began to send daily e-mails to the 4,000+ member workforce. Content included news updates about the lab, safety announce- ments, positive highlights of individ- ual department achievements, and employee wellness tips. To promote inclusiveness to all employees, ARUP conducted video ‘town halls’ as another means to respond to workforce questions and concerns. ‘It’s important to be informative and transparent during such stressful times,’ the authors pointed out. ‘This facilitated sensi- tive discussions about work reduc- tion that included hourly and sal- ary reductions across all depart- ments and jobs, voluntary leaves of absence, and the lab’s financial health due to significant reductions in routine tests.’ FAQ for staff The lab also developed a frequent- ly asked question (FAQ) list to address clinical questions from staff and physicians. This was updat- ed and expanded as needed. The answers provided were aligned to guidance provided by the World Health Organisation, the United States Centers for Disease Control and Prevention, and existing inter- nal policies and procedures regard- ing safe handling of respiratory specimens. Additionally, a Covid-19 Communications Group, comprised of marketing and communications staff, immediately developed a new website page of links to published resources, podcasts, material, and a free public laboratory test selection support tool. Supporting staff in turbulent times Prior to the onset of the pandemic in late February 2020, this non- profit enterprise of the University of Utah’s Department of Pathology processed over 60,000 clinical tests a day. Routing testing volume dropped with the pandemic. ARUP pivoted to divert some lab and financial resources and staff to sup- Editor-in-Chief: Brenda Marsh (BM) Editorial team: Wolfgang Behrends (WB), Sonja Buske (SB) Senior Writer: Mark Nicholls (MN), Great Britain Mélisande Rouger (MR), Spain Publishing Director: Mareike Scholze (MaS) Executive Director: Daniela Zimmermann (DZ) Founded by Heinz-Jürgen Witzke ISSN 0942-9085 Correspondents Austria: Michael Krassnitzer (MK), Christian Pruszinsky (CP) France: Jane MacDougall (JMD) Germany: Anja Behringer (AB), Walter Depner (WD), Cornelia Wels-Maug (CWM), port SARS-CoV-2 molecular testing by its Molecular Infectious Disease and Molecular Genetics laboratories to maximise capacity for Covid-19 diagnostic test orders and serology, including cytokine testing. Keeping the employee base intact and safe Because clinical laboratory staff represents a highly trained scarce resource that cannot be easily or quickly replaced, ARUP’s guiding principle is to keep its employ- ee base intact and safe during the pandemic. This has included a mix of offering work flexibility options, including remote working, where feasible; temporary leaves of absence; implementing temporary work and salary reductions fair- ly to both workers and managers; maintaining health benefits for all, and stringently implementing and enforcing safety measures. The increase in remote work options necessitated bolstering information technology services to support increased network use. Fiscal budget changes The authors note that, because labo- ratory cash flows tend to be rela- tively stable and predictable, creat- ing an operating budget for the following year tends to be a simple process of minor modification. The impact of a pandemic changes this. They recommend that because expenditures need to be evaluat- ed based on cash availability, lab managers should adopt a dynamic budget mindset. ARUP implemented a rolling forecast model and has suspended non-emergency spend- ing. Its objective is to preserve cash Karoline Laarmann (KL), Katrin Schreiter (KS) Spain: Eduardo de la Sota (EdS) The Netherlands: Madeleine van de Wouw (MvW) USA: Cynthia E. Keen (CK), Lisa Chamoff (LC) Subscriptions Dorothea Fleischer, Theodor-Althoff- Str. 45, 45133 Essen, Germany Subscription rate 4 issues: 32 Euro, Single copy: 8 Euro. Send order and cheque to: European Hospital Subscription Dept Printed by: WVD, Möhrfelden, Germany Publication frequency: quarterly Representatives China & Hongkong: Gavin Hua, Sun China Media Co, Ltd. 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Brian R Jackson MD is medical director of support services, IT and business at ARUP Laboratories in Salt Lake City, Utah. and available resources wherever possible and to justify expenditures based on immediate and Covid-19 related clinical needs. ‘The clinical laboratory environ- ment is very regulated and therefore adverse to quick change, but the crisis has required big decisions to happen fast,’ Genzen pointed out. ‘We’ve learned to be nimbler and more efficient, but cautiously, so as not to compromise quality.’ E-Mail: jund@european-hospital. com GB, Scandinavia, BeNeLux: Simon Kramer Phone: +31 180 6200 20 E-Mail: kramer@european-hospital. com Israel: Hannah Wizer, International Media Dep. of El-Ron Adv. & PR Co., Ltd., Phone: +972-3-6 955 367 E-Mail: firstname.lastname@example.org Taiwan: Charles Yang Phone: +886 4 232 236 33 E-Mail: email@example.com USA & Canada: Hanna Politis, Media International Phone: +1 301 869 66 10 E-Mail: firstname.lastname@example.org Maria Kaiser Phone: +1 250 726 4007 E-Mail: email@example.com Roxsy Mangiante Phone: +1 21 469 48542 E-Mail: firstname.lastname@example.org All company, brand and product names in this publication are the property of their respective holders. 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@ ECR W W W. H E A LT H C A R E - I N - E U R O P E . C O M 2021 S P E C I A L I S S U E F O R T H E E U R O P E A N C O N G R E S S O F R A D I O L O G Y O N L I N E E V E N T V I E N N A A U S T R I A M A R 0 3 - 0 7 2 0 2 1 Awareness is key for breast screening services time,” he said. With 3DQuorum, resolution and detection are better, he pointed out. It is an integrated solution that reduces the number of 3D images to review by two-thirds, improves workflow efficiency and can literally take an hour of work off an eight-hour shift. Educating consumers As a global leader within breast health, he underlined Hologic’s commitment to patients and custom- ers during the pandemic. This has seen Hologic reach out directly to patients with educational resources to raise and maintain awareness of the importance of breast cancer screening. In the United States, Hologic launched a “Back-to-Screening” con- sumer education initiative which focused on reminding women of the importance of mammograms and not missing examinations, and how facilities were working to be Covid- safe. In Europe, a similar breast can- cer awareness campaign addressed women directly, but targeted via social media. The European cam- paign will continue in 2021. Another element supports cus- tomers on tomosynthesis breast can- cer screening and products such as ultrasound technologies, hand-held Daniela Zimmermann speaks to Samir Parikh, Hologic’s Global Vice-President (Research & Development and Clinical Affairs), about the company’s approach to raising post-Covid awareness of breast screening. poned has created an additional burden on health systems as they move out of Covid” said Mr Parikh, who has been with Hologic for 24 years and from the start of the com- pany’s digital journey. Addressing the backlog With early detection a critical part of the breast cancer journey, awareness and access to screening are impor- tant messages for women as ser- vices pick up, but he acknowledged patients need to feel “comfortable” about coming back to screening ser- vices. Healthcare facilities are taking precautions, but that is adding to workload and means procedures will take longer. “The biggest challenge,” he con- tinued, “is how do we address the backlog and get back to that routine of annual screening for everybody, not just breast cancer? We believe this is where Artificial Intelligence will play a significant role.” Mr Parikh highlighted how Hologic’s Genius AI™ technology can improve workflow efficiency by enabling radiologists to read images more efficiently and help reduce backlogs. “AI is core of where we are going,” he said. “We believe AI will continue to help how we improve, not only in cancer detection or operational efficiency, but also affecting clinical outcome across the whole pathway.” Digital breast tomosynthesis (DBT) remains a proven technology within the mammography sphere, but having images sliced into 1mm segments in some systems can lead to fatigue with a 5cm area of breast resulting in 50 slices to scroll through. Hologic’s Genius AI solution sees the company’s 3DQuorum™ Imaging Technology, Powered by Genius AI™, create 6mm SmartSlices where each high-resolution SmartSlice overlaps the previous one by 3mm, ensuring there is no loss of 3D image data and continuity in scroll- ing. HIghlighted regions of interest “This not only overlaps, but with the AI underneath we are making sure regions of interest that are impor- tant to a radiologist – lesion, clas- sification, masses – are highlighted and that helps reduce the workflow Hologic’s 3DQuorum technology The impact of Covid-19 has been dev- astating; countless lives lost, millions of infections worldwide, health sys- tems overwhelmed and economies rapidly shrinking. In addition, rou- tine operations have been cancelled, patients have avoided Emergency Departments for fear of catching coronavirus or hampering health workers, and others have failed to seek help when they should have consulted a physician. Health experts fear this is stor- ing up a negative health legacy for years ahead as patients present with worse symptoms than if they had sought timely help. Screening, such as for breast or cervical cancer, is an area particular- ly affected, with numerous appoint- ments delayed. It is against this backdrop that Hologic is working to pave the way for a return to a degree of normality for when the coronavirus pandemic passes. Raising awareness Central to that is a role in raising awareness among women about the importance of breast cancer screen- ing, alongside helping health sys- tems reduce backlogs and restore screening to pre-Covid-19 levels. Within that are also steps to help clinician workflow and offset any increased workload. Samir Parikh has outlined how the company is raising awareness of breast screening with consumer education campaigns, and develop- ing innovations to support clinicians and health systems deliver effective screening programs post-Covid. At present, global health systems have a realigned focus to cope with Covid-19, which is having a signifi- cant effect on preventive screening and will impact future outcomes. He pointed to evidence in the UK that postponement of clinical cancer diagnostics and treatment may lead to 18,000 more deaths over the next year, while a French study found 38% of people avoided screening over Covid-19 concerns, and 28% did not want to further burden healthcare workers. Studies elsewhere in the world reflect a similar picture. “Breast cancer screening, cervical and other procedures being post- Samir Parikh is the Global Vice President of Research & Development. In this role, he is responsible for leading and driving innovative advanced solutions across the continuum of care to drive sustainable growth of the Breast and Skeletal Health division. Samir joined Hologic in 1997 and held positions of increasing responsibility over the years. and surgical devices, with a medi- cal education team established to deliver an educational and technol- ogy support structure. He said: “For us, the biggest learning point from Covid-19 was that it reinforced our commitment to providing insight- driven innovative solutions through- out the patient pathway. It is at the heart of what we do; it is about how we connect the dots from risk to screening, to diagnosis, biopsy, surgery, pathology, and to treatment and how we integrate our solutions for improving workflow and driving critical patient outcomes in a lifesav- ing way.” AI-led technology, he added, can improve efficiencies, reduce cost and burden, and “the impact of the backlog along the entire pathway.” Commitment for women’s health While Hologic has extended its portfolio with the acquisition of SuperSonic, he explained, that it will continue to see its portfolio evolve over the medical spectrum, with AI playing a crucial role but empha- sized Hologic’s commitment to, and core focus on, women’s health. Having structured the company’s innovation – internally, organically and through acquisitions – under- lines a sharp focus on the global pathway. “But this is just the starting point. Our goal is to impact a billion women in the coming years and we will not be able to do this unless our mission and purpose is very focused,” he concluded. “Hologic remains a leader in breast health and our commitment to that through innovation and technology remains our primary focus.” EUROPEAN HOSPITAL Vol 30 Issue 1/21
Introducing ATEM MiniThe compact television studio that lets you create training videos and live streams!Blackmagic Design is a leader in video for the medical industry, and now you can create your own streaming videos with ATEM Mini. Simply connect up to 4 HDMI cameras, computers or even technical equipment. Then push the buttons on the panel to switch video sources just like a professional broadcaster! You can even add titles, picture in picture overlays and mix audio! Then live stream to Zoom, Skype or YouTube!Create Training and Educational VideosATEM Mini’s includes everything you need. All the buttons are positioned on the front panel so it’s very easy to learn. There are 4 HDMI video inputs for connecting cameras and computers, plus a USB output that looks like a webcam so you can connect to Zoom or Skype. ATEM Software Control for Mac and PC is also included, which allows access to more advanced “broadcast” features!Use Professional Video EffectsATEM Mini is really a professional broadcast switcher used by television stations. This means it has professional effects such as a DVE for picture in picture effects commonly used for commentating over a computer slide show. There are titles for presenter names, wipe effects for transitioning between sources and a green screen keyer for replacing backgrounds with graphics!Live Stream Training and ConferencesThe ATEM Mini Pro model has a built in hardware streaming engine for live streaming via its ethernet connection. This means you can live stream to YouTube, Facebook and Twitch in much better quality and with perfectly smooth motion. You can even connect a hard disk or flash storage to the USB connection and record your stream for upload later!Monitor all Video Inputs!With so many cameras, computers and effects, things can get busy fast! The ATEM Mini Pro model features a “multiview” that lets you see all cameras, titles and program, plus streaming and recording status all on a single TV or monitor. There are even tally indicators to show when a camera is on air! Only ATEM Mini is a true professional television studio in a small compact design!ATEM Mini ..........265€*ATEM Mini Pro..........525€*ATEM Software Control..........Free* Recommended retail price excludes VAT and shipping and delivery costs. ATEM Mini for use in training, conferencing and teaching purposes only.Learn more at www.blackmagicdesign.com/nl
1 0 E H @ E C R Viewing through a ‘window’ empowers management How to shape a blueprint for progress Hospital data from a wide range of disciplines, departments and specialties strongly influences crucial decision-making and planning. Agfa HealthCare’s Business Intelligence solution, for example, uses data to measure, understand and predict developments, and aims to present this information in an accessible and transparent way so that administrators need not even ask for in-house generated reports. Agfa’s Business Intelligence product manager Tommy Vansteenkiste, and Willy Rosé, representing Agfa’s Imaging IT solu- tions marketing division, discussed the firm’s solution with Mark Nicholls. waiting times to see if there are peaks that can be flattened to provide a bet- ter patient experience, and how fast a report is delivered to the ordering physician,’ he added. ‘It’s about ensur- ing the operation runs smoothly, and also keeps a quality of service.’ Benefits can be measured in many ways, such as time efficiency and tracking how long it takes to provide a service, whilst also offering a check- point on a system’s quality. Here, identifying peaks and supporting changes in the scheduling and plan- ning of examinations, for example, can improve treatment delivery. More Agfa HealthCare’s Business Intelligence solution recently, the solution has tracked the growth of coronavirus and associ- ated changing service demands and delivery. ‘What we are seeing is where there are dips in certain procedures and those coming back in again. That can give input on resourcing and what is coming up and what a hos- pital might need to plan and change,’ Vansteenkiste pointed out. facet Diving into something strange A key is how Business Intelligence allows users to explore the data in detail. ‘The end user can explore data and add certain attrib- utes or “slice and dice” the data in a different way,’ he explained. ‘Often, There is a solution that amalgamates all hospital data – e.g. involving per- sonnel, equipment, patients’ waiting times, room occupancy, age groups and regions from which they have been referred, workflows and bot- tlenecks, and the use of an imaging device (e.g. if one CT scanner is used more than another, indicating further equipment investment). The solution reveals multiple aspects of the organi- sation, helping to streamline opera- tions and processes, accreditation, capacity and investment planning. It also monitors trends and helps with billing accuracy and quality improve- ment. Vital assessments during the pandemic This ability has proved particularly important during the coronavirus pandemic, during which assessment of workflow, capacity, and perfor- mance has been and is crucial. As Business Intelligence prod- uct manager Tommy Vansteenkiste observed, ‘The solution brings data to the fingertips of the end user.’ A department head can identify where there is room for improvement, view market information, assess a shift in the use of certain equipment, or where investment is needed. Clinical staff can also assess workflow, perfor- mance and future workloads. ‘It helps with resourcing and planning, patient After a 15-year engineering career at Agfa Gevaert, Willy Rosé transitioned to the role of Head of Marketing IT Europe at Agfa HealthCare. Leading a team of 10 highly skilled professionals, he connects the dots between regional sales organizations, R&D, finance and solution management. you do not know what you are look- ing for until you see it. The whole point of Business Intelligence is that you see something strange and dive into it and look what the issue is. We are not only giving the data more to the end user, but we are enabling them to explore the data.’ Willy Rosé, from Agfa’s Imaging IT solutions marketing arm, confirmed that the tool’s value lies in identify- ing areas that need improvement and where problems lie. ‘You can use it to mine the data, see where a prob- lem is; fix or improve, and measure again.’ He further outlined the solu- tion’s capability to focus on human performance. ‘If you can measure how many duplicate examinations you do, you can investigate if it’s because of equipment, people, or the process and, by doing that, you can Tommy Vansteenkiste joined Agfa HealthCare in 2004 as part of the IT R&D department and has been active in differ- ent roles in both R&D and Global Services. Currently he is Product Manager for Enterprise Imaging’s Business intelligence solution bringing actionable insights to Medical Imaging providers. increase operational efficiency and avoid unnecessary examinations. That is where Business Intelligence comes together with clinical intelligence.’ Identifying staff who need support If the analysis system reveals that some personnel take longer to per- form a task, this may suggest a need for support, or question whether the workload is being effectively distrib- uted across devices – for example, not overloading CT scanners. The Agfa Business Intelligence solution is also a powerful tool in terms of monitor- ing performance; producing reports for accreditation and documenting improvement, and measuring patient and referrer satisfaction. In a nutshell: The solution aims to transforms data into actionable insights leading to more informed decision-making and improved opera- tional efficiency. With easy access to all operational data and reports, it can help to detect productivity gaps, maximise modality utilisation, and optimise resource utilisation and per- formance. As Rosé summed up: ‘The Business Intelligence system is a win- dow on a hospital’s data, workflows, and performance.’ Images and patient data combined Integrated radiogenomics improves clinical outcomes Harnessing radiomics power and adopting an integrated way to com- bine imaging and patient data could improve cancer outcomes. Now, clinicians can explore a non-invasive method to identify the heteroge- neity of a tumour and more accurately target regions for biopsy. During a presentation at ECR 2021 in March, Professor Evis Sala will underline the importance of inte- grating data to build a clear, non- invasive diagnosis and potentially cut down on the need for biopsies, as imaging and radiomics builds up a clear view of a lesion. Her current research focuses on integrated diagnostics through the clinical development and validation of functional imaging biomarkers to rapidly evaluate treatment response using physiologic and metabolic More than just MRI accessories www.allmri.com tumour habitat imaging. Sala’s pres- entation, ‘Linking radiomics features to other omics data in clinical prac- tice’, will review potential applica- tions of emerging radiogenomics, and discuss how to analyse big data. The Cambridge team com- bines multi-layered data – radiomics, clinical, and blood data (CA 125 in the case of ovarian cancer) – with e-genomics, including circulating tumour DNA, and patients’ history, to develop algorithms to predict treatment response. Robust data to create a robust biomarker Underlining the need to have robust data to create a robust biomarker, Sala’s examples will concentrate on CT scan and ovarian cancer. She also emphasises the importance of keeping the research grounded in everyday practice, to ensure the developed biomarkers actually will be useful in the clinic. A challenge lies in making the transition from qualitative research and data to quantitative findings and turning that image data into num- bers. ‘That’s not going to be pretty to the eye,’ she acknowledged. ‘As radi- ologists we are visual, but we have to extract things we don’t see with our bare eye because that’s where the quantitative information is.’ Sala, whose work integrates quan- titative imaging methods for evalua- tion of spatial and temporal tumour heterogeneity with genomics, pro- teomics and metabolomics, points out that the additional features to acquire the quantitative informa- tion rely on heterogeneity, which is imperceptible to the human eye. ‘It might not be exciting to radi- ologists, but it is so crucial to feed that information into the algorithms that can actually predict response and outcome.’ To extract the quantitative features from an image, the first major step is to segment the lesion. Whilst labori- ous in metastatic disease, this has led to the development of automatic segmentation. Once the lesion is segmented and the radiomics data extracted, it is fed into the treatment prediction algorithm with other clin- ical and molecular data. Her team is working on the use of this tool to create a ‘virtual biopsy’ to reduce the number of biopsies needed, by more precisely targeting the optimum site EUROPEAN HOSPITAL Vol 30 Issue 1/21
E H @ E C R Clinical audits in radiology to promote high quality medical care The QuADRANT project 1 1 Advertisment Report: Mark Nicholls Clinical audit within radiology depart- ments can help promote high qual- ity medical care and improve patient experience, as well as provide edu- cational and teaching opportunities. Aiming to see consistent delivery across Europe, clinical audit is cur- rently under the initiative ‘Diagnostic and Interventional Radiology, Radiotherapy, and Nuclear medicine including Therapies’. The latest project is being con- ducted on behalf of the European Commission (EC) by a consorti- um led by the European Society of Radiology (ESR), including the European Society of Radiotherapy and Oncology (ESTRO) and the European Association of Nuclear Medicine (EANM). QuADRANT progress will be updated during an ECR 2021 ses- sion led by Professor David Howlett. This aims to help radiologists under- stand the principles of clinical audit, as well as deliver an update on the ESR Esperanto audit project. Howlett, who chairs the ESR Audit Standards subcommittee and leads the QuADRANT project, explained that the EC launched this in January 2020, to improve quality and safe- ty in radiology, radiotherapy and nuclear medicine through clinical audit (‘a systematic process where- by medical radiological practice is examined against agreed standards with modification of practice if needed’). ‘The EC want us to look at clinical audit across Europe,’ he explained, ‘to find how and where it’s being done well; what are good prac- tices, and what the barriers are to clinical audit, but with a par- ticular emphasis on clinical audit as mandated within the EU Basic Safety Standard Directive (BSSD)’ (2013/59/Euratom). The project looks at clinical audit implementation and procedures against a backdrop of seeing it embedded in clinical practice in support of the BSSD, which is now mandatory within the EU. The ESR has also developed the EuroSafe Imaging initiative to support and strengthen medical radiation protec- tion across Europe. The session will explain five key work packages of Images and patient data combined for biopsy. ‘With imaging, this can track the entire tumour border, not just one lesion, and point out the region for biopsy.’ Sala believes the concept is close to deployment in the setting of a clinical trial and validation. ‘It’s about understanding the biology of what we are seeing, how we can use this cross-scale investigation and interrogation to then limit the num- ber of biopsies, or biopsy the most useful part of the tumour.’ A key learning point from this ECR session will be that maximum benefit is achieved from integrating the data. ‘Integrating them will give a more powerful, robust way of pre- dicting an outcome,’ Sala added. She also emphasised the impor- Overview of workflow leading to the creation of virtual biopsy maps from key areas which can be used, along with real time biopsies from key areas, to inform clinical decisions. Source: P Martin- Gonzalez et al (2020). Integrative radiogenomics for virtual biopsy and treatment monitoring in ovarian cancer (https://doi.org/10.1186/s13244- 020-00895-2). Insights into Imaging. Republished under a Creative Commons Licence. www.healthcare-in-europe.com Source: Shutterstock/LEDOMSTOCK tance of radiologists enhancing their contribution by gaining knowledge of oncology; teamwork; having a multi-disciplinary approach with algorithm developers working close- ly with clinicians to develop the AI; and bringing patients into the research phase for the perspective they offer. (MN) Professor Evis Sala is a consultant radiolo- gist at Addenbrooke’s Hospital, Cambridge, UK, and, since late 2017, has been Professor of Oncological Imaging at the University of Cambridge, having previously served as Chief of Body Imaging Service at Memorial Sloan Kettering Cancer Center. Sala leads the Radiogenomics and Quantitative Imaging Group in the Department of Radiology and co-leads the Cancer Research UK (CRUK) Cambridge Centre Integrative Cancer Medi cine Theme and Advanced Cancer Imaging Programme. Consultant radiologist Professor David Howlett is with East Sussex Healthcare NHS Trust and is also Honorary Clinical Professor of Radiology at Brighton and Sussex Medical School, UK. He specialises in head, neck and symptomatic breast imag- ing. He is also chair of the European Society of Radiology Audit and Standards subcom- mittee and project lead for QuADRANT. the 30-month project. Howlett will examine the importance of clinical audit; review the role of audit within the BSSD; examine ESR audit-relat- ed initiatives; review the project, examining timelines and outputs of work packages; and consider chal- lenges and potential benefits for QuADRANT. The five work packages included an initial conference webinar meet- ing in December – to give back- ground and current practices in member states. and Dr Adrian Brady, Head of Department Consultant Radiologist at Mercy University Hospital, in Cork, Ireland, and ESR Second Vice-President, will update outcomes and recommendations from that session, while EC project officer Georgi Simeonov will discuss the project from the EC perspective. The next step will see the pro- ject survey clinical audit practice, process and infrastructure in all EU member states, plus the UK, Norway, Iceland and Switzerland. A further conference is planned for December 2021, with the fifth and final phase producing a summary conclusion and recommendations for the EC. Howlett said clinical audit is becoming increasingly rec- ognised within the clinical govern- ance process. ‘It’s part of quality improvement and an important tool in looking at practices and processes, and bench- marking against what is considered good practice,’ Howlett explained. ‘It has shown to be a very effec- tive tool in improving outcomes for patients and staff, but can also look at areas such as costs and enable departments to assess whether they are hitting targets and how things can be improved.’ The ESR has been active in audit- related initiatives, notably via the Esperanto document, launched at ECR 2019, which gives a back- ground to clinical audit and dis- cusses BSSD requirements, and also contains audit templates to allow departments to undertake their own audits. A new version of Esperanto is scheduled for 2022, with an upgrade in line with the project’s output findings. ‘QuADRANT will establish a roadmap of clinical audit activity across the EU, providing the EC, and thereby Europe, with a way forward for clinical audit that will help implementation and develop infrastructure, improving practice and process.’ Comfortable and secure: The swivelling handle system helps patients to position themselves on the examination table with as little assistance as possible – even when transferring from a wheelchair. Febromed provides support for everyday radiology work Safe and hygienic: „get up“ Whether in magnetic reso- “get up” by FEBROMED helps nance imaging (MRI), com- reduce this strain in day-to-day puter tomography (CT), diag- work to a minimum. nostic radiology, or radiation therapy: in radiology, it’s all Safety isn’t just a handling is- about the details. Highly spe- sue; everything has also been cialised equipment in a pro- carefully considered in terms fessional environment helps of hygiene. The “get up” handle to make exact diagnoses and system by FEBROMED is easy to implement precise therapies. disinfect and meets the highest Everything else needs to be hygienic requirements of a me- just as professional. dical environment. The material is extremely durable, an invest- We at FEBROMED can help ment in safety but also in cost with daily operations with the efficiency. “get up” handle system. With our handle system, patients can perfectly position themsel- ves on the examination table at their own pace. This takes the pressure off of medical person- nel, letting them concentrate on what’s essential: the examinati- on. Reducing workload In radiology, a large section of patients have restricted mobi- lity, something that can often present a considerable strain for medical staff. They have to use their full physical strength to move patients – and are in danger of becoming a medical emergency themselves. But be- sides the physical complaints, there are also costs for the em- ployer and the social system. The “get up” handle system can not only be mounted on the ceiling, but also on the wall. Photos: Febromed www.febromed.de Febromed GmbH & Co. KG Am Landhagen 52 | D-59302 Oelde Telephone Telefax E-Mail 0049 2522 92 01 920 0049 2522 92 01 919 email@example.com
1 2 E H @ E C R Portable ultrasound demonstrates versatility in all specialties Covid-19 – Testing time for people and devices which is easy to use and is respon- sive, even with gloves and gel. It can also connect seamlessly to the hospital’s electronic patient record (EPR) system. With a wide range of pre-sets to cover all POC exams, the device has full calculation packages included as standard. Three transducers can be connected at once with easy on-screen selection; there are 23 probes available ranging from 1 to 20MHz for high-definition imaging, and the machine boots up in less than 25 seconds, or three seconds from standby. At UMC, the TE7 is used in the recovery ward and to perform echo on patients’ lungs, heart and abdo- men. Also, should a patient need an emergency operation, it can be used to check whether the stomach is empty, or not. ‘We use a mobile machine because we do not have enough ultrasound devices to go around the 23 theatres we have, which are also on separate floors of our hospital,’ de Roos-Baron explained. Careful logging of equipment keeps track of where on site the five Mindray machines are at any time. Another advantage is that the device can last for 1-2 hours on Dr Karina de Roos-Baron at work battery, and then be plugged in or re-started promptly when needed. This is a robust machine – particu- larly important in the Covid envi- ronment where constant disinfec- tion is necessary – and it is easy and straightforward for ICU and theatre staff to cover the machines, the flat screen, and the probe with plastic protection. ‘What’s changed during Covid is that there is a lot more disinfection of machines,’ de Roos- Baron pointed out. This is in addi- tion to the constant use by staff of PPE and the time taken to put that on. While the theatres are working at reduced capacity, the ICU is very busy with Covid patients and, at UMC, additional ICU space has been created, with older wards reopened, re-purposed and re-equipped for coronavirus patients. Covid patients are also being treated on general wards, but can be moved to ICU if their condition deteriorates. In a nutshell, the benefits of the Mindray TE7 have become increas- ingly apparent to UMC staff during the coronavirus pandemic due to their mobility, performance, flexibil- ity and reliability. ‘In the beginning, I was sceptical, but we are pleased to have them,’ the UMC anaesthesi- ologist concluded. ‘As the person in charge of them, I think this is a very good machine.’ Due to the coronavirus, hospitals and medical staff developed new work practices involving, in acute settings, social distancing, rigid use of per- sonal protective equipment (PPE), handwashing, and disinfection of equipment every day. Additionally, portable, highly- mobile and versatile equipment came to the fore in point-of-care (POC) – particularly when wards and operating theatres are spread across several floors and access to specialist devices is at a premium. This proved the case in operat- ing theatres, wards and intensive care units (ICUs) at the Utrecht University Medical Clinic (UMC) in the Netherlands, where port- able ultrasound has supported swift and effective diagnosis of Covid-19 patients and supported treatment pathways. Anaesthesiologist Dr Karina de Roos-Baron, who works across the ICUs and operating theatres at UMC, said that during the second wave of the pandemic cases, and deaths remain high, with extra ICU beds opened up to cope with increasing numbers of Covid-19 patients. Here, ultrasound is playing a vital role. With wards and operating thea- tres spread across two floors at UMC, and not every unit having an ultrasound machine, the five highly portable and versatile Mindray TE7 machines are proving to be real workhorses. Elective surgery has been cut by half as operating theatre staff are redeployed to care for Covid-19 patients, meaning the portable TE7 is playing an increasingly important role. ‘This is a very mobile unit,’ de Roos-Baron confirmed. ‘It’s available at point-of-care, does not need a constant energy supply and is easy Anaesthesiologist Karina M M de Roos- Baron heads the regional anaesthesia working group at University Medical Centre Utrecht (UMC), the Netherlands. After completing medical school in Amsterdam, she gained experience in anaesthesiology and intensive care as a resident and fellow at the UMC and other Dutch hospitals. Keen to educate new staff, Roos-Baron is an instructor for the Acute Trauma Life Support (ATLS) train- ing programme as well as for the Dutch Association of Regional Anaesthesia (DARA). to disinfect. In the operating theatre, we use it for venous and arterial canulation and, in ICU, for vascular access.’ The hospital’s five Mindray TE7 systems are also being used by col- leagues in, for example, neurosur- gery, vascular surgery and urology. Also, with a programme starting for POCUS (point-of-care ultrasound), that role is set to expand further. The TE7 offers superior image quality, simple touchscreen opera- tion and intelligent tools to help speed up ultrasound examinations in demanding POC environments such as critical care, emergency and anaesthetics. It features a 15-inch high-resolu- tion anti-glare touchscreen display EASY ON PATIENTS EASY ON PATIENTS AND THE BUDGET. AND THE BUDGET. Accutron CT-D The diagnostics specialist. Quickly ready The diagnostics specialist. Quickly ready The diagnostics specialist. Quickly ready for use, intuitive to operate and self- for use, intuitive to operate and self- suﬃ cient thanks to latest battery technology. suﬃ cient thanks to latest battery technology. Hauptstrasse 255 · 66128 Saarbruecken · www.medtron.com Pan-European lung cancer screening Report: Mark Nicholls Pan-European lung cancer screening is challenged due to the range of approaches in different coun- tries. As attitudes towards smoking and smoking cessation programmes vary, experts are attempting to establish more unified lung cancer screening. The introduction of consistent pan-European lung cancer screen- ing will be outlined at a special session during the online ECR 2021, with presentations highlighting the current position in several countries. The session, entitled ‘Lung can- cer screening implementation in Europe: where are we now?’ will be chaired by Dr Annemiek Snoeckx, from the Department of Radiology at Antwerp University Hospital and the University of Antwerp in Belgium. With lung cancer causing 1.76m deaths a year worldwide (5,726 deaths a day), she will look ini- tially at the pivotal aspects of a lung cancer screening service, focusing on the 10 key points of eligibility criteria (who should be screened), plus shared decision-making; image acquisition; imaging review; good communication; smoking cessation; a multi-disciplinary approach; qual- ity assurance; cost effectiveness; research and Artificial Intelligence. ‘From there,’ Snoeckx said, ‘the session will focus on the strug- gles different countries encounter in the implementation of lung cancer screening. I think the biggest prob- lem now in Europe is that there are not yet any European recommenda- tions.’ Welcoming the recent move to include lung cancer screening in Europe’s Beating Cancer Plan, she gave a prediction. ‘I think one of the conclusions from the session might be that different countries have dif- ferent problems because they have different healthcare systems, but that there also are challenges that EUROPEAN HOSPITAL Vol 30 Issue 1/21
E H @ E C R 1 3 Updates: France, Germany, the UK, Croatia, Hungary, Poland, Russia Dr Annemiek Snoeckx is a chest radiolo- gist at the University Hospital of Antwerp and the University of Antwerp and is a co-founder of the Flemish Lung Cancer Screening Task Force. Her interest and research focuses on AI and biomarkers in lung cancer imaging, pulmonary nodules and screening. of France with different socio-eco- nomic profiles. Radiologists will be trained to use artificial intelligence in the process, with the work also evaluating AI as a unique reader. The study will additionally evalu- ate psychological consequences of screening among participants and the rate of detected co-morbidities, such as COPD and coronary artery disease. The hope, she explained, is that these trials will help shape future lung cancer screening pro- grammes in France. However, Revel stressed that only eradicating smok- ing will resolve the health threat, pointing particularly to rising cases of women of much younger age now presenting with Stage 4 lung cancer. ‘The smoking situation in France – and Spain – is really worrying. We have an epidemic of lung cancer in the female population. We need to change the way we consider smoking; for years it has been considered a way of life, as the expression of liberty, but being a smoker is a disease and is responsi- ble for so many deaths.’ Chest CT: lung cancer in the right upper lobe there is a reduction in lung cancer related mortality,’ she said. ‘So, we believe that now, the major reasons why lung cancer screening was not considered in France are not valid anymore.’ Funding has been granted for a national pilot study in France focusing on women aged 50-74 (the same catchment as for breast cancer). ‘We consider that women invited for breast cancer screen- ing, if they are eligible in terms of smoking history, could also benefit from lung cancer screening, and we also need more data on women.’ Another area of the work is in vali- dating readings to enable reliance on a single radiologist rather than double reading, said Revel, who also has a key role in a verification pro- gramme at European level, based on e-learning to train radiolo- gists in screening. Marie-Pierre Revel is professor and head of the Radiology department, Cochin hospital, University of Paris, and oversees the European Society of Thoracic Imaging (ESTI) Lung Cancer Screening Certification Project to introduce the European certifica- tion in nodule assessment and lung cancer screening. The French pilot study 2,400 females are participating in the French pilot study – selected from four areas an-European lung cancer screening Speaking to European Hospital ahead of the presentation, she explained that in 2016, France rejected lung cancer screening, mainly because of the high level of false positives from USA trials, and that European trials at the time did not confirm mortality reduction. However, that position has now changed following further studies in Europe. ‘What we know now is that lung cancer screening works and European trials have confirmed that The 10 elements of lung cancer screening are common and need to be tackled from a European level.’ Snoeckx, a co-founder of Flemish Lung Cancer Screening Task Force, explained that, in Belgium, lung cancer screening is organised on a regional level. She advocates a MDT (multi-disciplinary team) approach, including radiologists, medical physicists, tobacco cessation spe- cialists, pharmacologists, surgeons, radiotherapists, and epidemiologists and underlines the importance of the smoking cessation aspect to screening. Prepare to implement lung cancer screening Without clear European recommen- dations, she noted there is reluc- tance in Belgium – and other coun- tries – to press ahead with imple- mentation of formal and unified lung cancer screening programmes, though her advice is for nations to start preparing to be ready to imple- ment lung cancer screening. It is crucial, she underlined, for the EU to make recommendations on lung cancer screening and that pressure from member states could push that along. As another speaker in the session, Dr Marie-Pierre Revel, Head of the Radiology Department at Cochin hospital, University of Paris, will outline the position on lung cancer screening within France and ongoing plans to develop this. Her presentation will provide an overview of lung cancer screening studies in France, will discuss pilot programmes, as well as explain how French radiologists are being prepared for large-scale screening. Revel also has a role overseeing the European Society of Thoracic Imaging (ESTI) Lung Cancer Screening Certification Project (sup- ported by ESR) to introduce the European certification in nodule assessment and lung cancer screen- ing as a qualification to standardise training and expertise quality across Europe. www.healthcare-in-europe.com MORE CLARITYin cardiovascular imagingDue to an aging population, we are seeing a rising burden of cardiovascular diseases. Therefore we have developed sophisticated intraoperative imaging solutions that bring more clarity into cardiovascular interven-tions. Discover our innovative mobile C-arm solutions at www.ziehm.com/clarity.ALWAYS AHEAD
1 4 E H @ E C R Agfa’s SmartXR AI gives the digital radio- graphy workflow a boost · SmartDose uses 3D machine and more consistent projections. vision to determine the thickness of the patient, and then tailors the exposure parameters. This helps the technician to speed up the configuration of exposure settings, reduce retakes, improve image consistency, and ensure the ideal dose for the patient. SmartXR Assistant X-Ray Intelligence at work that are available for use with Agfa’s DR 600 and mobile DR 100s1. Defining what hospitals want from AI “The original ideas for possible features came from my time as an image processing researcher, work- ing with X-ray equipment in the lab. I found that I made a lot of mistakes and realized AI technology could potentially help me to avoid some of them,” Gert Merckx explains. To select which features to include in SmartXR, Agfa went directly to radiology managers and users. “We started by conducting customer workshops and data mining our workstation usage patterns to evalu- ate radiographers’ pains and needs. We found the greatest interest was in AI tools for optimising dose, improving positioning, and avoiding the nuisances that drive inconsistent imaging.” Based on these findings, Agfa developed SmartXR, which current- ly includes four sets of AI features SmartXR at a glance · SmartPositioning augments a live camera stream of the patient by projecting the image area and the AEC X-ray feedback sensor positions onto the patient’s body. This helps the technician speed up positioning, while making it more accurate and consistent to reduce retakes. · SmartRotate uses deep learning to auto-rotate images to their standard orientation based on the image content. Fewer post- processing actions are needed, while image presentation on both workstation and PACS is more consistent. · SmartAlign uses advanced sens- ing to give live feedback on the accuracy of the tube-to-pan- el alignment during bedside or out-of-bucky exams. Alignment is faster and more accurate, with fewer retakes due to grid cutoff Two SmartXR packs are available: the Convenience Pack includes SmartRotate and SmartAlign; and the Performance Pack includes the full set of intelligent features. An assistant, not a replacement The role of the tech- nologist in radiol- ogy is critical, not only from a technical standpoint but also from the perspec- tive of their i n t e r a c t i o n s with patients. “SmartXR is not intended to replace the tasks of the technicians, but rather to assist them in completing those tasks. It can help a less experienced technician to avoid errors, while lightening the workload for a more experi- enced technician. The technician remains in control – all the time,” describes Gert Merckx. “But a ‘help- ing hand’ that supports the work- flow reduces stress for both radiog- rapher and patient.” At ECR 2021, Agfa will introduce SmartXR to NEW: The CL-S1200 colour 30.9-inch monitor the European radiology field. Gert Merckx explains, “With SmartXR, we have given our imaging solutions eyes and a brain, we’ve made them aware of their environment and we have taught them their first skills. We are only bound by the limits of our imagination now.” 1 SmartXR SmartDose and SmartPositioning on DR100s is a work in progress. Contact your local sales representative for more information on the availability on the SmartXR tools in your region. Liv, the friendly face of Agfa’s SmartXR Imaging workflow assistant Control via PACS Another new feature of the CL-S1200 is the ability to control the display directly from the picture archiv- ing control system (PACS). JVC has developed and integrated a special interface to do this. ‘It allows the user to start the Visual Point Mode, for example, from within his famil- iar working environment and with- in the workflow. This darkens the areas outside the region of interest and enhances the contrast within,’ Herrmann points out. In addition, the presets, i.e. the defined default settings of the display for certain images, can also be switched from the PACS. ‘In doing so, the PACS transfers the respective DICOM tag to the MS-S1200, which then selects the appropriate pre-set,’ he explains. If a mammogram is to be found, the monitor would work with a bright- ness of 500cd/m², and with a CT scan with only 250cd/m². Sanitation Additionally, the smooth, flat design of the CL-S1200 ensures that both the monitor and the wide-angle swivel can be disinfected and thus maintain hygiene. Details: http://healthcare.jvc.com EUROPEAN HOSPITAL Vol 30 Issue 1/21 In the move to evidence-based medi- cine, healthcare budgets put more pressure on efficiency, while quality of care has to meet ever increas- ing standards. Agfa has chosen to direct its development of artificial intelligence (AI) solutions towards helping radiology departments meet these challenges. Agfa’s SmartXR AI upgrades for its digital radiography portfolio focus on supporting operational efficiency and clinical consistency, as Gert Merckx, Product Manager Radiology Solutions for Agfa, explains. An ‘intelligent’ approach to doing more with less “Eliminating waste, supporting quality care, and enabling an effi- cient workflow are certainly not new challenges! With our legacy in imaging going back 120 years, we have worked hand-in-hand with our customers to enable continuous improvements. But AI technology allows us to completely rethink the equation,” begins Product Manager Merckx. He continues, “One of the most pressing challenges for managers of imaging departments is a short- age of skilled technicians com- bined with more limited training on radiography. This raises problems that impact departmental quality and efficiency, including avoidable errors, high exam variability, and more.” Agfa is addressing these issues with SmartXR, which adds targeted AI-based features to its DR solu- tions. SmartXR acts as an ‘intelligent assistant’ to the technician, enabling a smoother and more efficient daily imaging workflow and more con- sistent images. Displaying medical images of different modalities, such as CT, CR/DR, MR, ultrasound or mammography and pathology, on one screen? That’s a radiologist’s dream – indeed, many place several medical displays side by side to see several scans at the same time. With its new 30.9-inch CL-S1200 colour monitor ,JVCKenwood has eliminated this awkward practice. With 12 megapixels (4,200 hori- zontal and 2,800 vertical), the device can display a variety of medical images side by side. The windows arrangement can be freely selected, and the large screen, without a cen- tre bar, creates a comfortable envi- ronment for radiological diagnostics. With a maximum brightness of 1200 cd/m² and contrast ratio of 1500:1, the monitor is also suitable for mam- mography. The CL-S1200 colour 30.9- inch monitor Analysing several scans on one screen succeeds even with moving images without any problems, although millions of operations per second are necessary here,’ explains Marcel Herrmann, Marketing Manager of Medical Imaging at JVCKenwood. Latest technology integration The display contains the latest technology. The patented Dynamic Gamma function, for example, analy- ses the entire screen content and selects the correct gamma curve for each individual pixel in real time. This applies to all images, whether ultrasound, endoscope, pathology or nuclear medicine, and always pro- vides an optimal representation. ‘This The innovative Turbo Luminance function can increase the bright- ness and contrast of the screen for a maximum of 30 seconds to magnify recognisable gray scales, the manu- facturer reports. ‘This allows radi- ologists to reliably assess even low- contrast lesions on mammograms. The effect is further enhanced by the Visual Point mode. ‘Luminance and colour tempera- ture are automatically adjusted in real time on the CL-S1200. The built- in colour front sensor on the screen constantly measures colour tempera- ture and adjusts changes over a long period of time,’ Herrmann explains. This is gentle on the examiner’s eyes – as is the built-in illumination on the back of the monitor and the indirect illumination of the keyboard and mouse, the company confirms.
D I G I TA L PAT H O LO G Y 1 5 Radiomics, pathomics and deep learning Computational imaging furthers precision medicine The advent of digital pathology provides the means to develop computerised image analysis to diagnose disease and predict out- comes for cancer patients from histopathology tissue sections. Report: Mark Nicholls Such advances can help predict the risk of recurrence, disease aggres- siveness and long-term surviv- al, according to leading expert Professor Anant Madabhushi, of Case Western Reserve University, Ohio, USA. Speaking to online delegates at the 7th Digital Pathology and AI Congress, Madabhushi outlined how tools are being developed to advance this area of diagnosis, prognostics and prediction. His team has developed a suite of image processing, computer vision and machine learning tools spe- cifically designed to predict disease progression and response to therapy via the extraction and analysis of image-based histological biomarkers derived from digitised tissue biopsy specimens. These have already been applied in the context of several different disease domains including breast, lung, oropharyngeal, prostate, ovarian cancer, and endomyocardial biopsies. He suggested the tools would serve as an attractive and cost-effec- tive alternative to molecular based assays, which attempt to perform the same predictions. His presenta- tion, ‘Computational Pathology as a Companion Diagnostic: Implications for Precision Medicine’, looked at the implications of such tools for preci- sion medicine against a backdrop of cancer diagnosis and mortality in the USA. With 600,000 deaths annually Spatial distribution of prostate cancer across a cohort of 80 men, colors reflect the frequency of occurrence in different prostate zones said, but they are expensive and have a limited success rate of 20-25%, and no clarity on which patients will benefit or respond to these therapies. This, he pointed out, underlines the need for better diagnostic, prog- nostic and predictive tools that will identify the presence of disease, as well as predict disease outcome and progression and the response to treatment. ‘AI, deep learning and machine learning can really aid the pathologist, but there is a real unmet clinical need for these tools which can benefit the clinician, the one who is interfacing with the patient and 40% of the population receiving a cancer diagnosis, he noted: ‘There is some discrepancy between those two statistics. ‘Some of the reasons why diagnos- tic incidence is high and mortality for the disease not in the same ball park is because we have become more aggressive about cancer detection, screening and imaging.’ Overdiagnosis harms patients Madabhushi warned that overdiag- nosis is harming patients – not only physically due to the treatments and side effects of therapy, but also financially with a high proportion of cancer patients having to invest their life savings in their treatment. While finding disease earlier leads to a more favourable outcome, he suggested computerised image analy- sis could play an increasingly impor- tant role in the cancer diagnosis and therapy evaluation. Immunotherapy is a game-changer for cancers such as melanoma and lung cancer, he and having to make treatment and management decisions. ‘This will support precision medi- cine by using prognostic and predic- tive tools for tailoring therapy for a given patient based on a specific risk profile.’ His group is working to under- stand the full value to be gained from the data gleaned from tissue biopsies and the unprecedented opportunity to use computational machine learn- ing tools on the digitised slides. ‘This will not only identify presence or absence of disease,’ he said, ‘but also mine data for digital interroga- tion of data from the perspective of mining digital biomarkers, to iden- tify features that can tell us about the risk of progression of disease, aggressiveness of disease, and how likely patients are going to respond to chemotherapy or immunotherapy.’ this illustrate Studies prove benefit To potential, Madabhushi highlighted a series of studies from his group where AI and machine learning had been shown to suggest which patients would benefit most from which treatment. These included one focusing on disorder of collagen fibre associated with risk of recurrence in Oestrogen Receptor Positive (ER+) breast can- cers in ECOG-ACRIN E2197 & TCGA. ‘This goes to show the value of these diagnostic tools to aid the clinician in figuring what the outcome is and how to treat these patients,’ he confirmed. ‘This is also true in early- stage disease.’ In other examples, Madabhushi outlined how a combination of com- puter extracted features of nuclear morphology, tubular formation and mitotic count predict disease-free Digitisation dawns in developing world The future of digital pathology is assured Pathologist Dr Talat Zehra reports from Pakistan Given the rapid transi- tion towards digitisa- tion, digital pathology is now unquestionably the future. However, some pathologists, particu- larly in underdevel- oped countries, are still reluctant to accept its place in their labs. Among their many reasons, some feel that histopathology is a very complex and subjective field and artificial intelligence (AI) software cannot cope with all the issues. Conversely, pathologists are also scared that AI might replace them completely. Last but not least, a large number of pathologists, particularly senior ones, or those who have not worked in the developed world, are not familiar with new modalities, so they are reluctant to adopt them. www.healthcare-in-europe.com Pathologists in many countries are eager to go fully digital – however, in some cases, crucial pieces are still missing (Image courtesy of Dr Alex Wright, University of Leeds) As for Pakistan, the bottleneck here is either the absence of pathology slide scanners, digital microscopes or manual whole slide image (WSI) software; if available ,they are main- ly used for educational or research purposes only. The use of AI is almost negligible, indeed very few pathologists know about this novel entity. Initially, I did some pilot projects to validate the results of AI software on previously diagnosed cases. For this I am highly thankful to Aiforia Technologies Oy, which gave me its demonstration version and training on AI software. Using this, I carried out some pilot projects on chorionic villi and malarial parasite detection and gained a good concordance of around 84%. We accomplished this project without a scanner or digital microscope. Despite slow adoption in many institutions and countries, the digital slide image is slowly replacing the glass slide. Aided by AI-based image analysis software, we can improve the much weaker and fragile health- care delivery in developing coun- Anant Madabhushi is the Donnell Institute Professor of Biomedical Engineering, Case School of Engineering, Case Western Reserve University, Cleveland, Ohio, and also Director of the Centre for Computational Imaging and Personalised Diagnostics. In the School of Medicine he is Professor in the Departments of Pathology, Radiation Oncology, Radiology, Urology and General Medical Sciences. His research interests include quantitative image analysis, radi- omics, pathomics (a central source for computational pathology), cancer imaging, and digital pathology. survival in ER+ breast cancer, and also how computer extracted images of nuclear shape, orientation disor- der and texture from whole slide imaging are associated with disease- free survival in ductal carcinoma in situ. He further detailed possibility of using similar approaches predicting post-surgical recurrence in prostate cancer, lung cancer, ovarian cancer, endometrial and cervical cancer. ‘Computational analysis with rou- tine imaging could help address questions in precision medicine, spe- cifically prognosis and predicting response to therapy,’ Madabhushi concluded. ‘The relatively low-cost aspect of computational diagnostic tools could also have global benefits, especially in low- and middle-income countries.’ And, he predicted, ‘the importance of establishing the con- nection to the molecular underpin- ning of the features, moving away from an abstract representation, is going to be a really important driver for clinical adoption and clinical utility.’ Dr Talat Zehra MBBS FCPS is assis- tant professor at Jinnah Sindh Medical University (JSMU) and consultant Histo- pathologist at JSMU Diagnostic Lab, Karachi, Pakistan. She gained her Bachelor of Medicine, Bachelor of Surgery degree in 2007 from Dow Medical College, Uni- versity of Karachi, Pakistan, and her fel- lowship in Histopathology at the College of Physicians and Surgeons of Pakistan. Zehra’s field of interest is digital pathology and the use of artificial intelligence in tis- sue imaging. Zehra has written a few arti- cles internationally to highlight the issues in delaying adoption of digital pathol- ogy techniques in the developing world. Currently, she is also a member of the edu- cation committee of the Digital Pathology Association (DPA). tries. These carry most of the world’s endemic disease workload but, Continued on page 16 Ki67, ER, PR, Her2 Imaging•Fully automatic•For WSI or microscope camera•LIMS IntegratedDigital Pathology Solutionswww.vmscope.com
1 6 D I G I TA L PAT H O LO G Y Multiplexing, DNA/RNA sequencing and AI applications An exciting new era for tissue microarrays A new generation of tissue microarrays are delivering more efficient, time-effective solutions to answer complex clinical and scientific questions, digital pathology allows specific and targeted analysis of small areas of tissue. During an online presentation of the 7th Digital Pathology and Artificial Intelligence congress, Professor Inti Zlobec outlined advances ‘From artificial intelligence to multiplexing: exciting avenues for next-generation Tissue Microarrays’. As of Head the Translational Research Unit (TRU) at the Institute of Pathology, University of Bern, Switzerland, Zlobec explored the potential of an approach pioneered through her unit’s development of next-generation Tissue Microarray (ngTMA), and looked at the benefits of coupling with digital pathology in translational research. A virtual goldmine The TRU has assembled a massive repository of pathol- ogist-annotated images through the ngTMA Facility, including whole slide and tissue microarray spots, linked to corresponding clini- cal and histopathological data, to create what the team described as ‘a virtual goldmine for training machine learning algorithms’. ‘Exciting new avenues for inves- tigation using tissue microarrays include multiplexing, DNA/RNA sequencing and artificial intel- ligence applications,’ she said. Underpinning their research at the Institute is the Tissue Bank Bern (TBB), a platform on which their collections of different tissues are used and stored for different stud- ies and analysis. This includes a frozen collection of 12-13,000 differ- ent tissue samples stored at -80°C. Outlining the evolution of TMAs from the late 1990s, Zlobec pointed to the benefits of having tissue cylinders in one block, making it easier to identify an area of focus. ‘It’s an incredible tool because they are easier to evaluate and it’s a research tool lasting years, depend- ing on the quality of the associated clinicopathological data. They create the same experimental conditions TMA of breast cancers with brain metastasis but with less resources and less material.’ Her group has focused on a subgroup of cells in colorectal cancer (CRC), called tumour buds, which are heavily related to CRC prognosis. ‘Tumour budding appears in many, or most, solid cancers and is a route to dissemination and metastasis,’ she added. ‘We wanted to capture these tumour buds and study them in terms of heterogene- ity of biomarkers. This would have been impossible using old TMA techniques because there is no guide to punch out very spe- cific areas. However, the way to do that would be to use a digital slide.’ That enables researchers to mark certain areas of interest and placing annota- tions on an image. ‘It is a digital pathology- based solution and works with annotation of a scan and align- ment with a block and creates beautiful TMAs,’ she pointed out. The ngTMA process is about con- structing a TMA that is very specific for the research project and, by using digital pathology as the basis, more questions can be answered. They can be used for pre- tumour cision medicine, rare dis- heterogeneity, eases/scenarios, to target histological areas, perform animal studies, and establish antibodies and new methods. Identify patients who will benefit most Examples include PD-L1 in colo- rectal cancer, to identify patients who will benefit most from immu- notherapy and the use of ngTMAs to answer the question about PTEN deletion, a known major cause of PTEN protein loss, correlating with aggressive characteristics and worst outcome. In addition, ngTMA has been used to compare the pro- tein expressions for breast, brain and pancreatic cancers. Future trends in ngTMA include multi- Inti Zlobec is professor and head of the Translational Research Unit and the Bern Tissue Bank at the Institute of Pathology, University of Bern, Switzerland. She leads the digital pathology project for rou- tine diagnostics as well as the colorectal research group which develops computa- tional approaches to address clinical questions. plexing, DNA/RNA sequencing and AI. Multiplexing can be expensive; scanning – and analysis – can be time consuming, but can lead to increased precision due to smaller areas/cores on which to concen- trate. ‘Scanning time can be avoided if you have a smaller number of slides,’ Zlobec explained. ‘One of the examples of multiplexing that we have helped to contribute to is CODEX, the application in co- detection by indexing.’ With colon cancer, the researchers plan to look at two different special types of immune cell infiltrates and investigate cellular neighbourhoods to orchestrate antitumoral immu- nity in CRC, processes that would not be possible using regular TMA processes. The ngTMA process also facilitates quality control, traceabil- ity and can support image analysis. With AI, the biobank offers a massive repository of images for machine learning and is a huge resource for training algorithms, though the challenge remains over management and efficient retrieval of the data. ‘TMAs are a highly valuable biobank collective,’ Zlobec con- firmed. ‘While useful for convention- al reasons, such as screening of bio- markers, they have an application in the new areas of multiplexing, genomic analysis and computational pathology.’ (MN) Every operating theatre is different - and we are prepared for it. In addition to technically and hygieni- cally high-quality wall-mounted consoles, operating theatre field monitors and all-in-one computers, we offer a scalable software suite that allows us to implement customized solutions for the medical IT sector. Our team integrates research and development, production and sales, project planning and service under one roof. With over 20 years of experience in the medical market, we stand for quality, innovation and reliable service. reinmedical.com The future of digital pathology is assured techniques, unfortunately, being less equipped with diagnostic the results are delayed diagnoses which, in turn, are associated with increased morbidity and mortality rates. The digitisation of pathology resources opens the door for the use of the massive potential of AI in pathology, which can speed up more accurate and reliable diagnosis. Additionally, integration will help to ease large data storage and predict the future outcome of disease, as well as per- sonalise care plans for each patient, and forecast oncology trends par- ticular to specific geographies. In this way, pathologists could suggest proactive approaches to prevent dis- ease progression. Thus, AI-enabled digital pathol- ogy use will transform the horizon of pathologists’ traditional clinical practice, which has been unchanged for many decades. The rise of the pandemic that penetrated the globe without discrimination, further enhanced the need for telepathol- ogy, which I and other pathologists belonging to my organisation use to send digital images to senior col- leagues in hospitals in Karachi to avoid unnecessary travel and expo- sure. However, the bottleneck in Continued from page 15 most of our setup has been the lack of pathology slide scanners or digital microscopes through which WSI can be sent easily. So, the idea of ‘working from home’ through devices emerged, which resulted in new norms in the thought process of pathologists, even in Pakistan, and will leave its impact even after the pandemic completely resolves. Additionally, an important and serious issue in digital pathology adoption is that a large number of technical, ethical and legal questions still need to be answered, particu- larly in developing countries with a weak monitoring system. A very important issue, which may not be a very big deal for developed coun- tries, is the high cost of scanners and AI-based software – among the reasons for delayed adoption of low resource setups and countries. That accounts for the delayed adoption of this novel technique in our area of the world. We sent the cases for second opinion in the form of digital images that we took through microscope cameras, which cannot produce a detailed image; so a second opinion is not always easy. Many times, senior pathologists ask us to come to their location because digital images are not enough to give a reliable consultation, particu- larly in difficult cases. So, due to the lack of scanners and digital micro- scopes, we have used digital images largely for research and educational purpose, not for routine clinical diagnosis. The role of world leading organi- sations of slide scanners and of AI software could be of great impor- tance. They could participate with pathologists and technical staff in developing countries, which are potential sources of big data, in terms of training, as well as to offer scanners, digital microscopes and software at a relatively affordable price, i.e. to put them within the budgets of low resource organisa- tions. Finally, I will conclude on the note that digital pathology and AI is in the forefront of modern pathology and its emerging use within health- care is now being realised. The novel technology is at our doorstep and it is better to welcome and accept it, otherwise a large proportion of the world population will suffer. EUROPEAN HOSPITAL Vol 30 Issue 1/21