2 O N C O L O G Y /W O M E N ' S H E A LT H Clinical computational tools Managing cancer more effectively Computational approaches are being applied on enormous amounts of data from sequenc- ing technologies to develop tools to help clinicians manage can- cer more effectively. Professor Serena Nik-Zainal explained that her team in Cambridge, UK, is working to further understand the physiology of mutagenesis to advance cancer diagnosis and care. Advances in the ability to read the human genome have made it pos- sible to sequence the entire 3000 million base pairs of the human genome in a single experiment. ‘My team at Cambridge uses this accel- erated whole genome sequencing technology to read all the muta- tions that are present in human cancers,’ explained Professor Nik- Zainal, who is NIHR Research Professor of Genomic Medicine and Bioinformatics and Honorary Consultant in Clinical Genetics at the University of Cambridge. She explained that human cancers are full of mutations that serve as an historic report of anything that has gone wrong in the cells as they turned into cancer cells. ‘If we can truly understand what those mutations signify, then we come closer to understanding the causes of each person’s cancer, and how to inform clinical decision-making for individual patients,’ she added. With computational methods criti- cal in studying the large mutation datasets, she explained that the two main groups of mutations to try to understand are: • the small handful of “driver” or causally-implicated mutations, which tend to happen in the body of genes, because these driver mutations can become targets for therapeutic intervention; and • the large swathe of mutations that form patterns across the genome, which are called muta- tional signatures. ‘Both of these types of mutations, drivers and mutational signatures, Montage of whole cancer genome visualisations: Professor Nik-Zainal’s team creates these graphical representations to enable clinicians to “read” them. Patient Reported Outcomes are important, because they help us to understand cancer develop- ment,’ the expert said. Her team is particularly interested in mutational signatures and per- forms laboratory experiments to understand how and why those mutational signatures arise. ‘Some of these signatures are like a sig- nal, a biomarker, of a biological pathway that is awry, and some- times those can be targetable,’ she continued. ‘For example, we can discern patterns of mutations that are due to DNA repair defects and drugs like immunotherapies can be used to target tumours with speci- fic DNA repair defects.’ Tools to manage the “data deluge” In order to derive maximum under- standing of mutagenesis, her team combines experimental work with computational approaches. ‘Ultimately, we want to use the new knowledge from the experimen- tal data and big cancer datasets to develop clinical computational tools that can help us to manage cancer more effectively.’ From there, the team applies statistical methods – such as machine-learning models – to cre- ate algorithmic tools. ‘The purpose of these tools is to enable clini- cians to quickly identify patients that may have sensitivities to par- ticular drugs or to help inform management in some way,’ added Professor Nik-Zainal. ‘We hope that our tools will facilitate clinicians in a future where cancer genomics is a routine part of cancer care.’ Given the current “deluge of data”, there are few easy ways to analyse and interpret it, so her team is looking to create apps to support clinicians in cancer genome inter- pretation. One example for this is an algorithm developed through machine-learning called HRDetect to identify tumours that have an abnormality in the BRCA1/BRCA2- dependent DNA repair pathway based on their mutational signa- tures. Creating the algorithm, however, was simply the first step, and sub- sequently the team had to demon- strate that HRDetect could distin- guish breast cancers with good from bad clinical outcomes. This saw collaboration with colleagues in Sweden, and later with those in London and with pharmaceuti- cal company Clovis to show that HRDetect was predictive of sensi- tivity to a drug. ‘We collaborated to show that our algorithm did have early predictive capabilities and that breast cancers with high HRDetect scores showed activity to treatment with a PARP-inhibitor drug,’ said Professor Nik-Zainal. Preparing for a data-driven future The next step is a Phase III trial with Genomics England – the national whole genome sequen- cing endeavour – to see wheth- er their clinical algorithmic tools can be implemented into the NHS bioinformatics pipeline. ‘The next stage of our work is to get our clinical algorithms to patients as soon as possible and get to a Phase III randomised controlled trial to Serena Nik-Zainal Professor Serena Nik-Zainal is Professor of Genomic Medicine and Bioinformatics and an NIHR Research Professor at the University of Cambridge, UK. She is also an Honorary Consultant in Clinical Genetics at Cambridge University Hospitals NHS Foundation Trust. Having been heavily involved in the development of the whole genome sequencing (WGS) using next-gener- ation sequencing (NGS) technology, she now leads the Genomic Medicine theme at the NIHR Cambridge Biomedical Research Campus. show that our algorithms really help inform patient care,’ she said. ‘Ultimately, genomics will become another tool in the everyday man- agement of cancer. Beyond cre- ating individual algorithms for genomic interpretation, there is a large piece of work involved in cre- ating holistic clinical decision sup- port tools and educating the next generation on how to use these tools so that they are equipped for  a data-driven future.’ Report: Mark Nicholls Going PRO to advance cancer treatment Involving cancer patients more closely in the treatment pathway can modify care and deliver bet- ter outcomes. Carefully designed questionnaires to gain a better insight into symptoms and the way patients respond to treat- ment are helping clinicians take therapies to a new level through a Patient Reported Outcomes (PROs) approach. Clinical oncologist Dr Alexandra Gilbert from the Leeds Cancer Centre in the UK is using PROs to improve measurement of patient symptoms, with a particular inte- rest in developing predictive bio- markers of radiotherapy effects and PRO methodology in clinical trials. While doctors traditionally respond to what patients tell them during clinics about side effects or adverse events, she explained that using a questionnaire for PROs can pro- vide extra information about side effects from the patients’ perspec- tive, including toxicity of treatment and the ‘quality of life impact of cancer treatment.’ With radiother- apy, the challenge clinical onco- logists face is in achieving the bal- ance between giving a dose to cure a patient of cancer, while keeping side effects to a minimum. ‘This is the real impetus for my research – to better identify radiotherapy side effects so that we could then try and improve our radiotherapy treatments,’ she explained. Patient participation improves insights Based on the findings so far, ques- tionnaires designed to measure changes over time have been developed with patient input. ‘It is also important that they are standardised to allow you to sta- tistically and robustly look for dif- ferences,’ she said. ‘With a good questionnaire, you can measure change over time and differenc- es between different treatments; you get much better granularity and detail about what patients are experiencing if you ask them directly.’ There are a range of val- idated questionnaires available for clinical practice or clinical trials; for example, the EORTC (European Organisation for the Research and Treatment of Cancer) Quality of Life group has 66 questionnaires covering different cancer areas in multiple languages. Gilbert, who is also Cancer Research UK (CRUK) Senior Clinical Trial fellow at the University of Leeds, said PROs are supporting better communica- tion, improving the patient jour- ney, recognising the patient voice, and improving outcomes. ‘There is good evidence that patients filling out a questionnaire about side effects can improve the way they are able to communicate with doc- tors. ‘More recently, randomised con- trolled trials have shown benefits in overall survival through using PROs in routine care because by regularly measuring side effects from the patient perspective, doc- tors are able to intervene and bet- ter support patients with their side effects, enabling them to carry on their treatment for longer.’ When using PROs in clinical prac- tice, Gilbert, who specialises in pel- vic cancers, said the questionnaires often prompt patients to talk about aspects they may not normally discuss, such as concerns about sexual dysfunction. Standardisation is key to consistency At cohort level, data collected can show patterns in patient symp- toms, enabling teams to better sup- port and identify interventions or develop preventive mechanisms for side effects. ‘That is really impor- tant, particularly in radiotherapy, where some side effects may not occur until years later,’ said Gilbert. Additionally, as patients may see different doctors during their fol- low up care, the accounts in the questionnaires allow for a consist- ency of story. As well as her research in PROs in radiation toxicity measurement in routine practice and clinical trials, she is involved in international projects to improve standardisa- tion of how PROs are measured, analysed, and reported and works with organisations such as the PROTEUS Consortium, which pro- motes tools and resources to opti- mise the use of PROs in clinical trials and practice. Stressing the need for consist- ency in PROs, she emphasised Alexandra Gilbert Dr Alexandra Gilbert is an Honorary Consultant in clinical oncology at Leeds Cancer Centre, and CRUK Senior Clinical Trial fellow at the University of Leeds, UK. Her research interests are in PROs in clinical trials and routine practice, and interventional radiother- apy trials. She is chair of the NCRI (National Cancer Research Institute) Methodology workstream and is an active member of the EORTC Quality of Life group. how studies are showing that this improved level of communication with the patient has an ‘obvious benefit in terms of overall survival  that is hard to ignore.’ Report: Mark Nicholls EUROPEAN HOSPITAL Vol 31 Issue 2/22

4 E H @ E C R Ovarian cancer and endometriosis detection Women’s health imaging: PET/CT and T2*w MR show promise Diagnostic imaging in women’s health advances: Positron emis- tomography–computed sion tomography (PET/CT) might provide a more accurate ima- ging alternative to CT in ovar- ian cancer. T2*-weighted MR imaging in deep endometriosis detection also shows promise, but ultimately falls flat. In a dedicated session at the ECR 2022 Overture in March, experts presented their latest research projects. Dr Elaine Yuen Phin Lee from the Department of Diagnostic Radiology at the University of Hong Kong talked about moni- toring treatment response in epi- thelial ovarian carcinoma (EOC) with PET/CT following neo-adju- vant chemotherapy (NACT). ‘EOC presents late as advanced-stage disease because early-stage disease tends not to present symptoms,’ she said. ‘Cytoreduction remains the most effective treatment and the ability to achieve complete cytoreduction is prognostic for sur- vival.’ To achieve cytoreduction, the patient can either undergo upfront cytoreduction or NACT, followed by interval debulking surgery. Treatment response to NACT is cur- rently assessed by CT, but this may not be accurate all the time, Lee explained. ‘The diagnostic accuracy of CT has quite a wide range, in between 57 to 94% depending on the study you look at. Mostly, this is limited by subcentimetre lesions and immeasurable disease, which is common in advanced stage car- cinoma,’ she said. By comparison, PET/CT offers accuracy rates that are consist- ently high, with reported figures of 90-95% in primary evaluation of EOC. The reason for this is that PET/CT picks up on the metabolic changes in the patients, which occurs earlier than the anatomical changes that are detected via CT, Dr Lee said. ‘Unfortunately, there’s a lack of data on the diagnostic accuracy of PET/CT in the set- ting of NACT in EOC.’ The expert and her team thus hypothesised that metabolic activity in these tumour deposits on PET/CT could increase the visual conspicuity of the tumours and diagnostic accura- cy after NACT in EOC. Evaluating the accuracy of PET/CT in monitoring treatment response The objective of the study Dr Lee presented at ECR was to evalu- ate the accuracy of PET/CT in monitoring treatment response in EOC after NACT. ‘We recruited 15 patients with stage III to IV of EOC who were scheduled for NACT and PET/CT after 3 cycles of NACT before interval debulking surgery,’ she explained. For PET/CT evaluation, the researchers divided the abdomino- pelvic cavity into 19 regions and used a 5-point Likert scale to score the evaluation, with 1 signifying the absence of disease and 5 being malignant. Region-based analysis was performed subsequently. Lee and her team also used his- topathological correlation as gold standard, and in the instances in which biopsy resection could not be performed, they took the surgi- cal evaluation as standard. They evaluated 285 regions with an accuracy of 88%, but low sen- ACCUTRON® CT-D VISION. SIMPLY MORE. The diagnostics specialist that can do more. More comfort, more mobility, more operating safety. More integration through Injection Data Sharing with RIS/PACS connection. View now at medtron.com sitivity at 38% and high specificity at 96%. Positive predictive value (PPV) was low at 56% while nega- tive predictive value (NPV) was high at 91%. This preliminary study showed that PET/CT achieves low sensitivity in all regions, but high specificity and NPV. Exceptions were found in two regions in the omentum, because of the presence of micro- scopic disease that could not be picked up on PET/CT, and also in the central pelvis because of low spatial resolution on both CT and PET examinations. ‘PET/CT is highly specific with high NPV in treatment response assessment after NACT in EOC,’ Lee concluded. Taking into account the relatively small sample size, she proposed that PET/CT might be useful in surgery planning, allow- ing for disease stratification to assess the viability of less aggres- sive and debulking surgery. the of following Endometriosis: A closer look at blood degradation products In talk, Dr Paolo Niccolò Franco from the Department Diagnostic Radiology at Papa Giovanni XXIII Hospital in Bergamo, Italy, shared the results of a study compar- ing T2*-weighted vs. stand- ard MR imaging performance in detection of deep endometriosis. ‘Endometriosis is a chronic gynae- cological disorder characterised by the presence of ectopic function- al endometrial tissue outside the uterine cavity,’ he said. ‘This condi- tion affects approximately 10% of women of reproductive age. Deep infiltrative endometriosis is defined as the presence of implants exten- ding 5 mm or deeper under the peritoneal surface.’ MRI has been shown to be an effective tool for both diagnosis and treatment planning of deep pelvic endometriosis. T2*-weighted sequences are susceptible to chro- nic blood degradation products – such as hemosiderin – which are visualised as signal voids. To take advantage of this, it has recently been proposed that these sequenc- es can provide added value to detect ectopic endometrium by identifying hemosiderin deposited during cyclic bleeding. The aim of Dr Franco’s study was to evaluate the diagnostic perfor- mance of T2*-weighted sequences, compared to conventional pelvic MRI protocol, in the detection of deep pelvic endometriosis. The researchers enrolled 44 patients who underwent a pelvic MRI on a 3T scanner for clinical and/or ultrasound suspicion of deep endo- metriosis. T2*w MRI prone to diagnostic overestimation Three readers independently eval- uated MR images. The first reader was a staff radiologist with ten A true positive lesion in the greater omentum involving the transverse mesocolon, confirmed at interval debulking surgery and subsequently on histopathological specimen. An ovoidal signal void (yellow arrow) on T2*-weighted imaging (left image) corresponding to artifacts caused by gas within the rectal lumen (white arrow), showed in a sagittal T2*w image (right). reader mistook some findings for endometriosis lesions, for example gas in the vaginal fornix and rectal lumen or artifacts caused by cae- sarean scars,’ the expert said. T2*w sequences do not seem to bring added value to expert read- ers in their assessment of endome- triotic lesions, Dr Franco conclud- ed. ‘Artifacts caused by undesirable sources of magnetic signal voids may lead to diagnostic overesti- mation, especially for readers with  limited experience.’ Report: Mélisande Rouger years’ experience, who analysed images taken with both conven- tional MRI protocol and T2*w sequences. The second reader, a resident with 2 years’ experience, analysed conventional sequences. The third reader had limited expe- rience and analysed images taken with both conventional MRI proto- col and T2*w sequences. The first reader diagnosed endo- metriosis lesions mainly in the ovaries, the torus uterinus, retro- cervical space and the utero sacral ligament. The first two readers agreed on endometriosis sites on both conventional protocols and T2*w sequences. ‘The number of lesions detected by the third reader on T2*w sequences was signifi- cantly higher, mainly because the Elaine Lee Paolo Niccolò Franco Following her radiology training in the UK, Elaine Lee joined the Department of Diagnostic Radiology, Li Ka Shing Faculty of Medicine, University of Hong Kong in 2010 and is now a Clinical Associate Professor. She has subspecialty interest in gynae-oncol- ogy, specifically in the application of functional and molecular imag- ing techniques. She is the primary investigator and recipient of compet- itive national grants in advancing the research in gynae-oncology imaging. She enjoys post-graduate mentoring and undergraduate teaching. Dr Paolo Niccolò Franco was born in Cosenza, Italy, and obtained his medical degree at the University of Florence. He is a fourth-year resi- dent at the Post-Graduate School of Diagnostic Radiology of the University of Milano-Bicocca and his residency was at San Gerardo Hospital in Monza and Papa Giovanni XXIII Hospital in Bergamo. He has a special interest in pelvic, genitourinary, and gynaecolog- ical imaging. Dr Franco is a member of the European Society of Radiology and the Italian Society of Medical and Interventional Radiology. EUROPEAN HOSPITAL Vol 31 Issue 2/22

6 Round table discussion E H @ E C R Specialists build bridges in interventional oncology Delivering a drug directly inside a lesion using minimally invasive procedures opens up new per- spectives for patients and medi- cal teams. At the ECR Ouverture in March, speakers looked at how to best join forces to advance the promising field of interventional oncology during a round table discussion. Injecting a chemotherapeutic agent into a tumour locally has gained ground in clinical practice, but there is still some way to go before immunotherapy or other target agents are used in this set- ting, according to Prof Dr Thomas Helmberger. The Chairman of the Department of Radiology, Neuroradiology, and Minimally Invasive Therapy at Munich Klinik Bogenhausen, Germany, made a case for more interdisciplinarity as he opened the session: ‘I’ve been lucky to work closely with oncolo- gists and surgeons for many years,’ he said. ‘Traditionally, specialists dealing with oncological patients tend to stick to their specific ther- apies for a long time before they even consider trying something else. Nevertheless, joining efforts for our patients will be worth- while.’ Stepping out of the comfort zone While he sympathised with onco- logists being cautious about inter- ventional oncological treatment options, or even feeling “threat- ened” by interventional radiolo- gy, Helmberger advocated that they should not hesitate to seek radiologists’ support to provide collaborative therapy concepts. ‘Interventional oncology has proved its efficiency and safety in hundreds of thousands of patients worldwide. When the first proce- dures were introduced 30 years ago, other specialties were scepti- cal too. Now, tumour embolisation for hepatocellular cancer, radioem- bolisation and thermal ablation – to name a few – are standard,’ he said. Today, peripheral and cerebral vas- cular procedures remain at the core of interventional radiology’s scope. One of the main obstacles to further deployment in oncol- ogy is the reluctance of many radiologists to work in this setting since it might be more demanding. ‘Interventional oncology is much more interactive and challenging for radiologists because they have to think like an oncologist and learn about new terminology,’ Prof Helmberger said. ‘They have to deal with patients who are often much sicker, facing complex ther- apies, and they also have to advise their families, just like a surgeon or an oncologist would.’ An aging population and increas- ing cost pressure on healthcare systems accelerate the trend for hospitals to deliver smart multi- modality treatment options, the expert predicted. In this setting, radiologists can provide more than just reading scans. ‘You’ll have to learn to leave your comfort zone and step into the treatment field,’ he said, addressing his radiologist colleagues. ‘Interventional oncolo- Andrés Cervantes Thomas Helmberger Andrés Cervantes is Head of the Medical Oncology Department at the University Hospital of Valencia and Professor of Medicine at the University of Valencia, Spain. He is the General and Scientific Director of the Institute of Health Research - INCLIVA. His main areas of interest and research are gastrointestinal and gynaecologi- cal cancer, as well as Phase I trials and new drugs development. Thomas Helmberger is Professor of Radiology and Chairman of the Department of Radiology, Neuroradiology, and Minimally Invasive Therapy at Munich clinic Bogenhausen, Germany. His medical specialties include diagnostic imaging of the abdominal and thoracic organs, including functional and tissue-spe- cific imaging (liver, pancreas, small and large intestine), the spectrum of diagnostic and interventional vascular medicine, and interventional oncology. gy is a very smart career choice for the new generation.’ Clear benefits for the patient The expert went into detail on the benefits of interventional oncology, which can help oncologists manage systemic treatments’ side effects in patients. For instance, local application of low dose chemo or immunotherapeutic agents can also allow disease control, while Mammography Breast cancer screening: AI shows promise A major new study shows that artificial intelligence (AI) is a promising tool for breast cancer detection in screening mammog- raphy programs. through Mammograms acquired population-based breast cancer screening programs produce a sig- nificant workload for radiologists. AI has been proposed as an automated second reader for mammograms that could help reduce this workload. The technology has shown encour- aging results for cancer detection, but evidence related to its use in real screening settings is limited. 123,000 examinations performed on more than 47,000 women In the new study — the largest of its kind to date — Norwegian researchers led by Solveig Hofvind, PhD, from the Section for Breast Cancer Screening, Cancer Registry of Norway in Oslo, compared the performance of a commercially available AI system with routine independent double reading as performed in a population-based screening program. The study drew from almost 123,000 examinations performed on more than 47,000 women at four facil- ities in BreastScreen Norway, the nation’s population-based screen- ing program. The dataset included 752 cancers detected at screening and 205 interval cancers, or cancers detect- ed between screening rounds. The AI system predicted the risk of cancer on a scale from 1 to 10, with 1 representing the lowest risk and 10 the highest risk. A total of 87.6% (653 of 752) of screen-detected and 44.9% (92 of 205) of interval can- cers had the highest AI score of 10. The researchers created three thresholds to assess the perfor- Managing Directors: Walter Schweinsberg, Bernd Müller Founded by Heinz-Jürgen Witzke ISSN 0942-9085 Correspondents Austria: Michael Krassnitzer (MK) France: Jane MacDougall (JMD) Germany: Cornelia Wels-Maug (CWM) Karoline Laarmann (KL) Katrin Schreiter (KS) Dr Christina Czeschik (CC) The Netherlands: Madeleine van de Wouw (MvW) USA: Cynthia E. Keen (CEK) Subscriptions Simone Sesselmann kundenservice@mgo-fachverlage.de Subscription rate 4 issues: 32 Euro, Single copy: 8 Euro. Printed by: mgo360 GmbH & Co. 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Publisher Mediengruppe Oberfranken – Fachverlage GmbH & Co. KG E.-C.-Baumann-Str. 5 95326 Kulmbach/Germany Phone +49 (0) 9221/949-311 Fax +49 (0) 9221/949-377 Editor-in-Chief: Mareike Scholze (MaS) Production Manager: Sonja Buske (SB) Editorial team: Wolfgang Behrends (WB) Sonja Buske (SB) Sascha Keutel (SKE) Senior Writer: Mark Nicholls (MN), Great Britain Mélisande Rouger (MR), Spain Publishing Director: Mareike Scholze (MaS) A N S R © Images in a 60-year-old woman with an invasive screen-detected cancer with an artificial intelligence (AI) score of 1 on the screening mammograms. (A) Mammogram of left breast from craniocaudal view. (B) Mammogram of left breast from mediolateral oblique view. (C) Craniocaudal cone view mammogram with magnification. AI score is defined as the overall examination-level score from the AI system, and a score of 1 is indicative of low probability of breast cancer and 10 of high probability. The arrows indicate the malignancy. mance of the AI system as a deci- sion-making tool. Using a threshold that mirrors the average individual radiologist rate of positive interpre- tation, the proportion of screen-de- tected cancers not selected by the AI system was less than 20%. AI will be of great value in interpre- tation of screening mammograms While the AI system performed well, the study’s reliance on ret- rospective data means that more research is needed. ‘In our study, we assumed that all cancer cases selected by the AI system were detected,’ Hofvind said. ‘This might not be true in a real screen- ing setting. However, given that assumption, AI will probably be of great value in interpretation of screening mammograms in the future.’ The results showed favora- ble histopathologic characteristics associated with a better progno- sis for screening-detected cancers with low versus high AI scores. Opposite results were observed for interval cancers. This may indicate that interval cancers with low AI scores are true interval cancers not visible on the screening mammograms. The Solveig Hofvind © Cancer Registry of Norway/Kreftregisteret EUROPEAN HOSPITAL Vol 31 Issue 2/22

8 E H @ E C R Patient-focused radiography Dementia and autism patients in the MRI: not aggressive, just lost Patients with neurological condi- tions such as dementia or autism can prove especially challenging for radiographers. A session at the ECR Overture in March gave insights to a patient-focused approach, with experts sharing the results of research projects as well as touching insights from their own experience. Professor Mark McEntee, a radio- grapher at University College Cork, Ireland, opened the early morning session by presenting the work of one of his students on the attitude of radiographers towards management and care of patients with dementia. In a moving pres- entation, the expert shared his experience both as a radiographer and the parent of a patient with dementia, a range of symptoms often misunderstood as a disease. ‘Dementia is an umbrella term used to describe a range of symp- toms rather than a disease itself,’ he said. ‘Dementia is associated with cognitive impairment and multiple diseases such as Alzheimer’s.’ While there are about 400 diseases that can cause dementia, a com- mon factor is the gradual shift in behaviour, McEntee explained. In early stages, family members might start to notice subtle changes in the execution of simple tasks like making tea, managing schedules or medication. As dementia advances, communication becomes more dif- ficult. ‘Caregivers may be needed for daily tasks such as feeding, dressing and personal hygiene. That can be troubling for fami- ly members, as the person with dementia begins to forget peo- ple’s names,’ the expert said. In late stages, full time care is often needed, with many patients having problems eating and swallowing, and become susceptible to infec- tions. Conflicting concerns for radiographers As his own mother suffers from dementia, McEntee had to switch perspectives to visit the x-ray department as a patient relative. He wrote down some of the expe- rience in a personal reflection that was published in the Journal of In another talk, Nikolaos Stogiannos from City University of London, UK, shared the results of a study that looked at the patient’s perspective in autism friendly MRI. ‘Autistic individuals may experience com- munication challenges, heightened anxiety and increased response to sensory stimuli,’ Stogiannos said. ‘They also face different challenges when accessing healthcare servic- es, such as poor staff awareness, stigma and suboptimal commu- nication. These differences may result in great challenges and a poor patient experience when coming to an MRI environment.’ The isolated and noisy MRI unit in combination with long scan times and the need for patient immo- bilisation often cause significant challenges to autistic individuals, he added. Two online surveys were con- ducted in autistic adults and chil- dren to explore efficient ways to improve both radiographers’ prac- tice and patient experience. The surveys were distributed through the UK National Autistic Society, More than just MRI accessories www.allmri.com Medical Imaging and Radiation Sciences in 2021. This personal view of dementia tells the story of an x-ray examination and was the basis for a study he carried out with student Caitlin Devereux and radiographers in Ireland. In the study, they asked participants to detail their experience and atti- tudes towards patients with demen- tia. The radiographers expressed concern about their practice and worried about patient care and imaging quality, but also about distressing patients. ‘They worried about patients’ fear and safety, but also about physical violence, consent and justification for the examination,’ McEntee said. that there was a stigma around the symptom. They were nervous that they were going to annoy patients or get them worked up.’ Those fears show common mis- understandings and highlight the necessity to change practice, the expert stressed. ‘We need to improve radiographers’ practice and knowledge about demen- tia patients and dementia care. Radiographers must remember that a patient is not an aggressive per- son, but someone who’s confused and scared. We should all involve the carer in the examination and bring them in the examination room. That will make the biggest difference,’ he concluded. Some of those concerns are based on a lack of training, knowledge, and education, he explained. ‘Radiographers said they would have liked to have more experi- ence with those types of patients experience and didn’t feel empow- ered to do things differently,’ he summarised. ‘They didn’t know what to expect but were aware k c o t s r e t t u h s – k u n o K t n e v e L © the imaging service demand of an increasingly ageing population  with cancer care needs. Report: Mélisande Rouger Mark McEntee Prof Mark McEntee is the Chair of Diagnostic Radiography at University College Cork and the Deputy Editor of the Journal of Medical Imaging and Radiation Sciences (JMIRS). When his mother was diagnosed with dementia in 2010, he realised how little work had been done on caring for patients with dementia during imaging. He has subsequently carried out focus group surveys with patients and radiogra- phers in Australia and Ireland and has written and presented on the subject, with the aim of translating research into practical guidance. Nikolaos Stogiannos Nikolaos Stogiannos is Honorary Research Fellow at City University of London. He is also a research assistant at the University College Cork, Ireland, and the Lead MRI Radiographer in the Medical Imaging Department at Corfu General Hospital, Greece. EUROPEAN HOSPITAL Vol 31 Issue 2/22 the London Autism Group, and the researchers’ networks on social media. From the 128 valid respons- es that were received, poor com- munication was identified as the main obstacle to successful MRI scans. Non-disclosure of autistic identity was noted in more than half of the respondents, which resulted in MRI departments unable to pro- vide customised examinations. Patient empowerment Poor patient experience was main- ly attributed to the acoustic noise, lack of physical comfort inside the scanner and lack of integrat- ed aftercare. ‘To improve exami- nations, MRI departments should receive adequate and timely infor- mation about a patient’s autistic condition and have the capacity to reduce acoustic noise during the examination,’ Stogiannos said. ‘Radiographers must ensure physi- cal comfort inside the scanner and offer other scan options, for exam- ple open-bore scanners.’ Autistic service users should also be encouraged and empowered to disclose their autistic identi- ty as well as their needs and preferences prior to the examina- tion. ‘Customised communication should be employed to achieve autism friendly MRI examinations. Radiographers should always adapt their communication style to their patients’ needs,’ he concluded. Other talks in the session fea- tured Dr Francis Zarv from Msida, Malta, who spoke of the effect of music during mammography breast screening; Elin Kjelle from Gjøvik, Norway, who detailed the implementation of a telemedi- cine and stroke evaluation ser- vice; and Anselm Chukwuani from Birmingham, UK, who focused on

1 0 P R E C I S I O N M E D I C I N E Advances in cancer risk assessment and prevention French oncologists pick up the pace after pandemic time-out The pandemic-imposed pause for oncology care is coming to an end: Real-life data and person- alised screening techniques are set to improve cancer prevention and patients’ quality of life. In a dedicated press conference in Paris, French oncologists pre- sented promising research that might bring hope for many can- cer patients. French cancer centres are catching up after the coronavirus pandem- ic put oncology interventions on hold in 2020, and the spirit of a fresh start was prevalent at an event organised by Unicancer, a federation regrouping 19 leading institutions specialising in oncol- ogy. ‘We’re getting out of it, after experiencing delays that have been detrimental to patients’ recovery,’ Unicancer President Jean-Yves Blay, a professor of medical oncol- ogy at Claude Bernard University in Lyon, said. After all, the pandemic left a consid- erable dent in cancer care: French facilities registered a 7% diagnos- tic delay for oncology patients in the aftermath of the Covid-19 outbreak in 2020. One year later, Unicancer centres, which treat about 20% of patients with cancer in France, reported a 6% increase in activity. Unicancer presented a series of proposals to better fight cancer, which remains the leading cause of death in France, with nearly 400,000 new cases and more than 157,000 deaths each year. Proposals target healthcare profes- sions’ attractiveness and remuner- ation and offer strategies on how to boost follow-up and prevention. The experts agreed that 40% of cancers could be avoided if cur- rent knowledge about risk factors was translated into effective pub- lic health strategies. ‘We want to develop highly connected research points to improve prevention from risk factor identification to screen- ing,’ Blay said. ‘Treatment follow-up of cancers in children and rare can- cers, which remain difficult to treat, is also one of our priorities.’ With over 100 studies enrolling 8,000 patients in 2021, Unicancer touches on several aspects of research beyond the clinical spec- trum, focusing on issues such as patients’ quality of life and how to make use of data which is already available. A few months ago, the organisation launched a pilot project with Health Data Hub, a platform dedicated to facilitating the sharing of health data from a wide variety of sourc- es, to help accelerate research. The program, called UNIBASE, aims to harness data from electronic patient records and create a collec- tion of cancer reference databases within three years. ‘Having this huge amount of real-life health data will help us better predict or evalu- ate treatment,’ Blay said. Personalising screening and patient involvement Underlining the historical weak- ness of France’s public health cul- ture, the latest report of the French National Audit Office on preven- tion policies mentioned ‘mediocre results’, despite significant financial efforts similar to those of European neighbours. For example, screen- ing remains problematic in France. National programmes are organ- ised for breast cancer, colorectal cancer and cervical cancer, but par- m o c . k c o t S e b o d A – a i d e m . r e b i e r h c s r e t e p © ticipation remains insufficient. To improve screening efforts, research- ers are looking to more personalised approaches, for example in breast cancer screening programmes. To this end, Unicancer is taking part in MyPeBS, an EU-funded randomised controlled trial that aims to assess the value of personalised breast cancer screening for women aged 40 to 70 in Europe. The study plans to determine whether risk-based cancer screening in these women is non-inferior to the standard screen- ing programme currently offered in Belgium, France, Israel, Italy, and the United Kingdom. The pro- ject will follow 85,000 women over four years and could mean a great advance, Blay explained. ‘This study is a revolution in screening manage- ment. If completed, it will transform the routine,’ he said. Patient empowerment is another promise of personalised cancer medicine. The aim is to involve the patient in clinical decision-mak- ing, another speaker highlighted in the conference. ‘We’re witnessing a cultural change and a reconstruc- tion of clinical decision-making,’ Ariane Weinman, a representative at EURORDIS, a non-governmen- tal alliance of rare disease patient organisations, said. ‘Patients and their increasingly involved and informed, sometimes even receive dedicated training to prepare for the experience.’ families are Patient organisations also increas- ingly take part in clinical trials, which benefits everyone, according to Weinman. ‘The more involved the patients are, the better they will be able to follow their treatment and support research near the  authorities,’ she concluded. Report: Mélisande Rouger Artificial intelligence and Deep learning to drive precision medicine Diving into medical big data Big data is transforming diagno- sis and medical care, but the criti- cal challenge remains over how to equally apply the benefits it delivers across real-world clinical settings. Industry expert Benoît Macq recognises that high quality data can be harvested from major university hospitals and academic centres but is convinced that the true value will emerge when it is accessible in a relevant way to clinicians and patients in smaller hospitals too. Prof Macq, who leads the PiLAB research team from the Institute of Information and Communication Technologies, Electronics and Applied Mathematics (ICTEAM) at the Université Catholique de Louvain in Belgium, explained that large-scale data sets can create predictors for diagnosis, treatment planning, and drug use, by har- nessing Artificial Intelligence (AI) and Deep Learning (DL) technolo- gies to acquire and analyse data to realise these goals. However, what An example of a prototype of Cone Beam CT that Prof Macqs team jointly developed with the IBA company for image-guided proton therapy. In the photograph is (from left): Eric de Lamotte (IBA), Benoît Macq, Merence Sibomana (PiLAB) and Rudi Labarbe (IBA). is key is that there is no centralised point of the data, but a system of “federated learning” where the DL model accesses a range of data silos in different hospitals. This brings data together to create a dis- tributed big data set, but with each institution retaining control of its data from a regulatory, cybersecuri- ty and patient privacy perspective. From this concept of federated learning, which groups organisa- tions together, the drive is to move to the next step of coalitional learn- ing between different institutions ‘to feed the new predictors, the new diagnosis and the new biomarkers’. With a challenge lying in the vary- ing data quality, annotation, clinical decision making and diagnosis, the move from federated learning to coalitional learning will help pro- vide cross control of data quality, he said. That will remove the variabil- ity in data and ‘align human judge- ment across a coalition’ in sharing data, procedural approaches, and joint strategy on the use of the data. A shift to coalitional learning increases the quality of the data, ensures validated expertise, and increases accuracy, said Professor Macq, who already applied this together with his team in areas such as proton therapy treatment planning and early detection of breast cancer. As an engineer, rath- er than a clinician, he emphasised the importance of ‘diving into the data’ from different places and making sense of it and being rel- evant to the patient. ‘We want to have a convergence with a coali- tional learning system where the data acquisition and the predic- tive model is increasing thanks to the contribution of the different institutions,’ said Macq. He further underlined the importance of diffe- rent types and sizes of institutions working together, as well as engi- neers collaborating with clinicians and data scientists, in constructing a DL model that is applicable and relevant to all clinical institutions and their patients. Precision medicine The benefit is to create precision medicine to deliver better diag- nosis and patient care, but also facilitate improved natural medi- cine. ‘The idea is to better under- stand diseases by trying to find causal relationships between DNA, RNA proteins and metabolics, and between different levels in the biol- ogy continuum to augment medi- cine,’ he said. He believes precision medicine will lower the costs as screening will be more efficient and treatment more precise and personalised. ‘Accessibility is our goal,’ he said, ‘and to increase the quality of treatment because it will be more personalised and delivered earlier Benoît Macq (ICTEAM) at Professor Benoît Macq leads PiLAB, a research team from the Institute of Information and Communication Technologies, Electronics and Applied Mathematics the Université Catholique de Louvain in Belgium, where around 30 researchers focus on three main research topics of: Signal & Pixels, Medical Imaging, and Interaction. The co-founder of 11 spin-off companies, he is a Fellow Member of the IEEE (The Institute of Electrical and Electronics Engineers) and a Member of the Royal Academy of Science of Belgium. with better diagnosis and better screening.’ This, he hopes, will cre- ate a new democracy to the use of the data so patients – whether at a university hospital or local hospital  – will benefit equally. Report: Mark Nicholls EUROPEAN HOSPITAL Vol 31 Issue 2/22

1 2 L A B O R AT O R Y Sponsored • Congress of the European Society for Emergency Medicine Preanalytical challenges and their clinical impact in POCT The European Society for Emergency Medicine (EUSEM) held their annual congress on October 27th to 31st, 2021 in the Portuguese city of Lisbon, to promote education, training and research in European acute care. The event’s hybrid format allowed for more than 2000 in-person and virtual delegates from over 70 countries. On October 30th, BD Life Sciences, Integrated Diagnostic Solutions (IDS), hosted a lunch-time edu- cational workshop entitled, ‘The impact of non-reported point- of-care testing (POCT) errors on patient care and hospital resources.’ The event was moderated by Anthony Malpass, Clinical Project Manager, BD IDS and presented by a team of expert guest speakers: Kevin Rooney Antonio Buño Soto Ulf Martin Schilling • Professor Kevin Rooney, Consultant Anaesthetist and Intensivist, United Kingdom • Dr Antonio Buño Soto, Point of Care Director and Head of Laboratory Medicine, Spain • Dr Ulf Martin Schilling, Consultant in Emergency and Internal Medicine, Sweden Throughout the presentation, attendees were interactively polled for their clinical opinions on a number of patient case studies to demonstrate the impact of POCT errors and their clinical conse- quences, even among experienced professionals. POCT and the imperative of test quality Professor Kevin Rooney explained that in a busy emergency depart- ment (ED), ‘POCT can reduce turn- around time ‘from vein to brain’ by bringing diagnostic testing to the patient’s bedside’. The ideal POCT kit meets the stand- ards established by the Institute of Medicine’s Six Domains of Health Care Quality: it is safe, efficient, and effective to use, and generates time- ly results which assist in providing equitable and person-centred care. So, POCT in the ED has the poten- tial to decrease delays to treatment, increase ED efficiency, positively influence patient care and negate the effects of overcrowding. The key word in that statement is ‘potential.’ For to meet this potential, the test- ing has to be of high quality. And therein lies the problem – the relia- bility of POCT results. Clearly if the sample is compro- mised, so too is the result. In a Stat laboratory setting, up to 61.9% of errors occur at the preanalytical phase due to the manual nature of sample collection. Similarly, POCT is susceptible to preanalytical error from poor sample quality and improper handling. Anyone, even an experienced cli- nician working in a busy ED, may miss a potentially erroneous POCT result, one that causes the develop- ment of a faulty clinical manage- ment plan. To prove the point, the audience was polled on the real- life clinical cases outlined below. Case Study: 30 weeks pregnant: emergency caesarean section or not? Rooney asked: ‘Would an incorrect POCT haemoglobin (Hb) force you down an incorrect management plan?’ A pregnant patient present- ed to the ED with 72-hour back pain radiating to the front, along with dizziness, shortness of breath, malaise and reduced foetal move- ment. She experienced increased urinary frequency from 20 weeks gestation. She also has a childhood history of vesico-ureteric reflux. On examination, the patient looked unwell: diaphoretic, anxious and writhing around the bed. • Glasgow Coma Scale (GCS) 14 with Verbal 4 (confused) • Temperature 37.5°C • Heart rate 138 BPM, blood pressure 82/63, capillary refill time 3 seconds • Respiratory rate 30, oxygen saturation 92% on air, reduced air entry at bases • Bloody show on her sanitary towel A POCT arterial blood gas analysis showed a partially compensated metabolic acidosis, with a carbon dioxide partial pressure of 3kPA, a lactate of 2.6 mmol/l and an Hb of 80 g/l. Was the patient experiencing a concealed antepartum haemor- rhage, requiring emergency caesar- ean section? 33% of the audience thought so. One hour later, the patient’s for- mal laboratory results arrived: white blood count 2.3 x109/l, Hb 106g/l, Haematocrit 0.3 l/l, C-reactive protein 100 mg/l. A diagnosis of urosepsis/pyelone- phritis was confirmed. Would the low Hb results guide you down an erroneous patient management plan? They did for one third of the audience. Urea and Electrolytes (U and E) and hidden haemolysis To further illustrate the impact of preanalytical errors, Dr Ulf Martin Schilling outlined the cases of three young women, each who presented with very similar com- plaints: severe abdominal pain and general malaise over the previous 24 hours, with vomiting, diarrhoea, nausea and vertigo. Their clinical observations were also similar and generally unconcerning. Then the Urea and Electrolyte results arrived: How can it be that while the women presented similarly, accord- ing to the blood results, one had a simple gastroenteritis while the other was undergoing a potentially life-threatening Addisonian crisis? Haemolysed samples can give an abnormally high K+ level or mask a true hypokalaemia. In central laboratory processes, haemolysis is flagged for a visual inspection of the centrifuged sample and sub- sequent analysis of the Haemolysis Index. However, with POCT these tools are not available, meaning Result Case Study 2 Case Study 3 Case Study 4 Potassium (K+) mmol/l Sodium (Na+) mmol/l Creatinine mmol/l Chloride (Cl-) mmol/l 3.2 128 65 90 4.2 135 95 98 5.2 122 110 90 Clinical interpretation Spurious result Hyperchloraemic hypokalaemic alkalosis + pseudohyperkalaemia Addisonian crisis haemolysed samples are not iden- tified. The hidden cost of preanalytical errors Following the case presentations, Dr Antonio Buño Soto presented the causes and costs of these pre- analytical errors. He demonstrat- ed that most errors in laboratory medicine occur in the preanalytical stage during patient preparation, blood collection and sample hand- ling/transport. He noted that the impact of errone- ous results can reach from patient management and safety to even the institute economy. But what about the impact of POCT preanalytical errors within the ED? According to Schilling, ‘Emergency departments have quite a high level of pre-analytical error’. As illustrated by the clinical cases, POCT errors in the ED can produce misleading readouts, with similar implications for patient care and resource use. What is the solution? Schilling advised the audience to ‘be sure that whatever is done, is of high quality’. The aim is to produce POCT results that are equivalent to those generated by a central laboratory. But what does this mean in practice? A multidiscipli- nary approach involving labora- tory professionals is the best way to mitigate POCT errors and to improve patient care. The central laboratory should lead and control every aspect of POCT: from the outpatient clinic to the hospital ward, from the intensive care unit to the physician’s office. Multidisciplinary involvement is supported by professional health- care organisations. ISO22870:2016, which is intended to be used in conjunction with ISO15189, gives specific requirements applicable to point-of-care testing, such as the creation of a POCT network and committee, whose members include representation from the central laboratory and who over- see all aspects of POCT manage- ment. k c o t S i © When interpreting POCT results, stop and think POCT is vulnerable to similar prea- nalytical errors as central laborato- ry testing but lacks the mitigating technology inherent to those sys- tems. Even if the POCT is impec- cably managed and operated, clini- cal discretion is required when actioning results. As Malpass said, ‘An analyser even if well main- tained, well quality checked, well controlled and well managed, is still capable of giving you a wrong result. It is based on the sam- ple put into it. If the sample is no longer representative of the patient, you are making judge- ments which could have significant consequences.’ Every caregiver’s primary aim is to provide the best possible care to all patients. Every clinical sample represents a human life, a per- son whose wellbeing relies on the accuracy of that sample. A good clinical decision is only support- ed by sound clinical results, and sound results can only come from a quality sample. If we depend on POCT to inform our clinical man- agement, we must ensure that the sample remains representative of the patient’s true clinical picture. Though complex and multi-facet- ed, mitigating preanalytical errors in POCT can be supported by the inte- gration of a dedicated, diverse POCT team that gives the ED central labora- tory support. Training, device mainte- nance and safety measures can then be rolled out, with evidence-based practice at the forefront. However, even if the ED has an exem- plar POCT system in place, Rooney cautioned the audience: ‘If you get a POCT result think, is that blood result  consistent with the patient?’ For references, please contact BD Life Sciences. EUROPEAN HOSPITAL Vol 31 Issue 2/22

1 4 L A B O R AT O R Y Diagnostic test regulation IVDR: Stop complaining, start contributing The in vitro diagnostic regula- tion (IVDR) aims to make IVD products safer, more reliable, and sustainable. Unfortunately, it is also widely regarded a bureau- cratic nightmare which will ren- der many tried-and-true lab tests obsolete, slow down diagnostics and generate horrendous addi- tional costs. At the ECCMID day on diagnostics, experts discussed the possible impact of the new IVDR on commercially available and in-house testing and why laboratories would do better to leave mere defiance behind. With large portions of the IVDR coming into effect in May 2022, the time for complaining about the new regulation is over, said Professor Elizabeth Macintyre, and instead appealed for a more con- structive approach. After all, the idea behind the new IVDR is sound, the expert attested: ‘The basic principle is that we do maximum patient benefit for the money spent.’ But while in prin- ciple, the bureaucrats devising the new rules act in the interest of the taxpayers and patients, they do not know about how laboratories work, she cautioned. ‘We have to be at the table when the imple- menting acts are happening. The devil is in the details, so we have to be involved.’ Speaking as a board member of the Biomedical Alliance in Europe, Prof Macintyre advocated the role of the organisation, which repre- sents 36 medical societies, in this process. ‘It is very difficult for the European Commission to reach out to all medical specialties since there are so many. So, one of the main interests of the Biomed Alliance is to speak as a common voice for our members.’ This gives the laboratories a chance to con- tribute to shape new legislation, rather than silently suffer its con- sequences. Six years to work out LDT implementation The impact of the new IVDR on everyday laboratory practice will likely be significant, the expert pointed out. ‘A main difference between the previous directive on IVD and the new IVDR is that the former was open to member state interpretation – and the lat- ter is not: It is to be applied as it is, to improve harmonisation and standardisation.’ Unlike its predecessor, the IVDR now also covers diagnostic tests developed in-house (laboratory-developed tests; LDTs). ‘This was born of good intention, to make sure that the tests are of optimal benefit to patients.’ This was a matter of concern, as in-house tests tend to be more complex than commercially availa- ble solutions. A recent survey from the Biomed Alliance to assess IVDR readiness among its mem- bers revealed that LDTs make up roughly 26% of tests used in laboratories, with some fields relying on in-house solutions for more than half of their diagnos- tics. Due to its high requirements for documentation, many critics see the new IVDR as a death knell for LDTs. However, there is a reprieve: Until May 2028, in-house tests may still be used under the condition that there is no equiv- alent solution on the market, or that the LDT is proven to be supe- rior to the commercial alternative. While this is a much-debated issue, Prof Macintyre believes that, if the remaining six years are put to good use, viable solutions will be found, with the key element being continued constructive com- munication. ‘The IVDR is there to dictate what we have to do, but it is up to us as diagnostic specialists to define and accompany how we do it.’ Who will go the extra mile for better tests? Judging from the results of the IVDR survey, the Biomedical Alliance so far mainly seems to be preaching to the converted: coun- tries with well-established pan-di- agnostic federative structures, such as Belgium or the Netherlands, were overrepresented, while other countries, which are more likely to run into problems with IVDR implementation, tended to respond less often, the expert noted. ‘My take-home message is that we need pan-diagnostic interaction between our societies, from pathologists and geneticists to laboratory med- icine, if we want to face up to these regulations in an appropriate fashion.’ She cautioned that coun- tries which lack such umbrella bodies will have a hard time pre- paring their laboratories for the new requirements, and thus be more susceptible for diagnostics companies peddling their IVDR- compliant solutions, instead of developing tests on their own. Prof Macintyre made it clear that the new regulation will make a temporary, but significant dent in diagnostic test availability: ‘There is no grandfather clause, so cur- rent tests will not automatical- ly be accepted.’ In other words, everything has to be retested – a tall order for the notified bodies in charge, with an estimated 30.000 to 40.000 tests to be approved. As a result, the diagnostic sector should prepare for vital tests simply disap- pearing, with no option of running in-house tests as a workaround. In the subsequent Q&A session, the expert voiced her concern of the increased regulatory require- ments stifling motivation to create new or improved LDTs across the fields: ‘I’m worried that many peo- k c o t s e b o d A - 4 0 8 1 r i i m d a l w © ple just won’t bother anymore.’ She predicted that, as soon as one diagnostic test is on the market, most experts would be content with the status quo, as finding ways to improve the test would simply be too much hassle. While the development would roughly take the same amount of work, the paperwork is another story, Prof Macintyre cautioned: ‘Bear in mind that you have to document every step, and clearly show to the health authority and national com- petence authority that everything is done according to good medical practice.’ ‘Working towards IVDR compliance will be a major effort in terms of time and budget,’ the expert sum- marised. ‘The cost of diagnostics is going to increase – we don’t know yet whether this will be offset by other benefits.’ To be prepared for the new IVDR, member societies of the Biomed Alliance declared a general need for guidance – infor- mation, templates and workshops on existing and upcoming stand- ards, availability of commercial diagnostic tests, and the sufficien- cy of both IVDR and ISO 15189 accreditation. Additionally, many felt that requirements for in-house tests should be more flexible. To meet the demand for IVDR-related guidance, the expert appealed to the diagnostic specialties to estab- lish overarching communication structures to provide and share information. While these structures should work on both national and European levels, possible synergies should be explored while redun-  dancies should be avoided. Report: Wolfgang Behrends Elizabeth Macintyre Professor Elizabeth Macintyre, MD PhD FRCP FRCPath, is a diag- nostic haematologist at the Necker- Enfants Malades Hospital in Paris, France, and President of the European Hematology Association (EHA). She is also board member of the Biomedical Alliance in Europe, an initiative of 36 European medical societies, and chairs the organisation’s IVDR task force. Sponsored • Safety blood collection set The gentle touch: Vacuette Evoprotect Evoprotect is the next stage in blood collection. The semi-auto- matic click mechanism protects the user from the risk of needle- stick injuries and makes the daily task of blood collection easier. Vacuette Evoprotect provides for gentle collection and safety from injury because we believe that every needlestick is one too many. The safety blood collection set meets current safety recommenda- tions and requirements and pro- vides substantial support for safe blood collection and infusion with the same set. User-friendly with optimised design The Vacuette Evoprotect is ergo- nomically designed and intuitive to use. It has a winged needle, spe- cially developed for one-handed use. The potential for needlestick injuries is minimized by the activa- tion of the safety mechanism while the needle is still in the vein. The Vacuette Evoprotect is suitable for a blood collection and a following infusion with the same set. The Vacuette Evoprotect Safety Blood Collection Set has a semi-au- tomatic safety mechanism. The trig- gers are located on the side of the product, facilitating one-hand- ed activation. The needle is then automatically retracted and, at the same time, safely and irreversibly enclosed in the safety shield. A clearly audible click confirms that the safety mechanism is success- fully activated. The safety mecha- nism is activated while still in the vein entry was successful. The tub- ing is designed to ensure that the needle stays as still as possible in the vein. The location of the safety mechanism triggers on the side of the device minimises the risk of the needle moving in the patient’s vein during activation. The same device can be used for taking blood and for a subsequent infusion following afterwards. Using the same set for blood collection and infusion means a second puncture is not needed. immediately O B G © patient’s vein, offering the user an even higher level of safety. The design of the safety mechanism promotes a straight removal of the needle from the vein, therefore offering more patient comfort. Designed with patient comfort in mind The ultra sharp, triple bevel needle tip ensures optimal patient com- fort. A view window between the needle and the tubing gives an immediate visual indication that More information: www.gbo.com  or www.power4safety.com. EUROPEAN HOSPITAL Vol 31 Issue 2/22

1 6 R O B O T I C S U R G E R Y Technology advances The importance of social sharing the During first Chemnitz’ Robotic-Symposium, two experts reported on the current state and the future of robot-assisted surgery and highlighted why it is a good time to be involved in this field of technology. gery and prostate, gynaecologic and cardiothoracic cases. Despite the rising number of procedures and systems, there are several dissenting voices. ’The criticism we sometimes get labeled with is that we are big boys with big toys,’ Tilney says. critical structures we’re trying not to damage,’ Tilney said. Additional benefits are that minimally invasive robotic interventions lessen the potential complications of larger wounds and shorten the patients’ convalescent periods. Once thought of as technique viable only in a far-off future, the use of robotics in surgery now is part of everyday life. The current systems are ’essential- ly master-and-slave-devices’, said Henry Tilney, MBBS, MD, FRCS, Consultant Colorectal and Robotic Surgeon, UK-Frimley Health NHS Foundation Trust. These machines are not autonomous, they are under the control of the surgeon in the operating room at all times. Robotic surgery can be used for many types of procedures, includ- ing cancer operations, colon sur- Yet there are real benefits to using robotics for patients. He pointed out that two known limitations of conventional laparoscopic surgery were the degrees of freedom and the mobility of instruments. The expert pointed out that robotics have a greater degree of move- ment within the abdomen and thus allowed the surgeons to essentially place mini versions of their hands in the abdominal cavity. That way, they would be able to manipulate and make small-scale movements with greater precision. ‘We get greater confidence in the dissec- tion we carry out and preserve the The state of robot-assisted surgery The major player in the market of robotics is Intuitive Surgical. Founded in 1995, the company introduced its first da Vinci system in 1999. Since then, the platform has gone through several refine- ments to become the benchmark that other systems are measured by. ’The “Ferrari of robotics” is the Intuitive 4th Generation Xi,’ said Joel Dunning, MD, MB.BCH, Ph.D., FRCS, Consultant Thoracic Surgeon, Department of Cardiothoracic Surgery, James Cook University Hospital. He added: ’Intuitive is really thinking about the best way to the actual mechanics of the robotic system itself.’ Another central player is CMR Surgical, which was established in 2014. Because they had some experience with robotics, Tilney’s team got involved with CMR in the early days of the company to help validate their Versius system. ‘We have always believed that the sys- tems we have now are not the sys- tems that we will use in the future,’ Tilney said and added: ’We wanted to be involved in the development of other systems to be part of what we termed “the democratisation of robotics”.’ R M C © One major difference in the sys- tems is Versius’ open console, Sponsored • CMR Versius Next-generation robotics Recovering from the pandemic impact, hospitals face increasing pressures and must find ways to optimise cost efficiencies whilst improving treatment quality. To achieve this, many institutions are embracing technology which helps reduce the cost of health- care and improve quality of care. CMR Surgical (CMR) is a global medical devices company dedicat- ed to transforming surgery with Versius, a next-generation surgi- cal robot. Versius was designed to give more power to surgeons, to make the benefits of minimal access surgery available to more patients. Approximately 16 million surgi- cal interventions are performed in German hospitals every year. Minimal access surgery (MAS) has revolutionised surgery, bringing many benefits, including reduc- tions in post-operative pain, com- plications and scarring, as well as a shorter length of inpatient stay and faster return to normal activ- ities. However, despite the proven advantages, only around half of the suitable procedures are performed using MAS techniques. Surgical robots enable surgeons to perform more minimal access sur- geries, allowing more patients to benefit from this type of treatment. The robots provide a practical way for surgeons to perform more com- plex and strenuous surgeries. Every day, surgeons set out to achieve the best outcomes for their patients. Versius has been spe- cifically designed with surgeons in busy operating rooms in mind to help meet high clinical stand- ards in surgery, while also offering essential versatility that hospitals running busy ORs need. More power to perform complex procedures: Versius enhances the surgeons’ accuracy and dexterity with its fully-wristed instruments, direct hand-to-instrument mapping and 3D vision. This gives surgeons the power to perform more com- plex procedural steps and entire procedures in a minimally-invasive way — whether fully robotic or using a combination of manual and robotic techniques. More power to operate with com- fort: Research has found that the leading causes of surgeon dis- comfort during MAS are awkward positions or movements, and pro- longed periods of standing. Versius has an open console which allows surgeons to sit or stand in an ergonomically beneficial position during surgery. This allows them to adapt their working environment to their ergonomic needs and helps to reduce the physical impact of surgery – with the potential to pre- vent early retirement of surgeons due to MAS-induced back, neck or shoulder pain. More power over port placement: Versius has a modular design that gives surgeons freedom of port placement to best suit the needs of their patient; enabling them to think laparoscopically, and act robotically. More power to maximise utilisa- tion: With a footprint of just 38cm x 38cm per bedside unit, Versius can fit into virtually any operating room and can be set up in a matter of min- utes. This gives hospitals the power which allows better interaction between the scrub team and the surgeon. The da Vinci system, how- ever, allows for a more immersive experience when surgeons put their heads into the box console. Yet, for Tilney, the difference is a matter of personal preferences. ‘We have two operating theatres with the Versius and da Vinci next to each other, and we can move com- fortably between the two.’ Besides da Vinci and Versius, sev- eral other systems are coming to market, e.g., Johnson & Johnson who, in 2019, acquired the remain- ing stake in Verb Surgical Inc. from Verily Life Sciences, a unit of Google parent Alphabet Inc. The companies had collaborated on surgical robot- ics since 2015. In 2020, Johnson & Johnson unveiled their Ottava platform, which features six arms to provide more control and flexi- bility in surgery, while its arms are integrated into the operating table. The company plans to start first in-human studies in 2022. The “new kid on the block” is Hugo by Medtronic. In 2021, the system was used in its first-ever patient procedure: a minimally invasive prostatectomy performed in Santiago, Chile. Each part of Hugo's system is housed on a sep- arate rolling cart and the surgeon can control up to four independent robotic arms during the procedure from one console. ‘I think more competition and more systems are only a good thing for robotics. It’s an area that is exciting to be in at the moment because it is developing so rapidly,’ Tilney said. ’Get away from the notion that the exciting thing about robot- ics is which system you are going to use – because they all are going to be good,’ Dunning said. For him, the future lies in sharing and scor- ing surgeons' videos. He pointed out that all players are working on solutions that imbed the capacity to capture videos during surgeries. One such surgical data manage- ment and learning platform already exists. Run by Johnson & Johnson, CSATS allows surgeons to track their performance, and refine their skills based on AI-driven clinical insights and analytics as well as assessment from board-certified surgical experts. ‘If we have an ecosystem in which we can share our robotic surgery videos, we are going to see it. We are going to learn and want to do it in that fashion. And that will become a vast advance in any randomised studies,” Dunning said. ‘Let’s innovate in robotics as well as in non-robotic surgery to decide what the best operation is. But the way we are going to innovate is by sharing our videos, by remote telementoring, and by patching into each other’s theatre,’ Dunning said. ‘This is what’s going to keep patients safe because we will be able to assess each other. This is why robotics is better than non-robotics, because of the ecosystem that is  being built,’ he concluded. Report: Sascha Keutel R M C © to move Versius to where it needs to be, whenever it needs to be there. What’s more, Versius provides a digital interface between the sur- geon and patient, opening up a wealth of insights to help surgeons and hospitals deliver the best sur- gical care and improve hospital efficiency. Versius is now an established surgi- cal tool and is being used by pub- lic and private healthcare systems across Europe, Australia, India, and the Middle East in a wide spectrum of specialties including gynaecolo- gy, urology as well as colorectal, general, and thoracic surgery. www2.cmrsurgical.com/more-power-to-you  EUROPEAN HOSPITAL Vol 31 Issue 2/22

1 8 H E A LT H I T Sponsored • RFID technology Modern authentication solutions for clinics A system for user authentication and access management is key for simple, as well as transpar- ent, processes in everyday hos- pital life. It thus contributes to an optimal working environment for staff and the best treatment conditions for patients. Because of this role, such a system can help clinics stand out from the competition. accessing Whether electronic patient records or gaining access to sensitive areas: a modern, uni- form system for user authenti- cation and access control based on radio frequency identification (RFID) ensures that permissions are exclusively granted for author- ized personnel. Not only does this simplify compliance with legal requirements, but it also ensures smooth processes. An RFID card, which staff members often already carry as an employee ID, is all that is needed to quickly gain access and entry to predefined areas. Authorizations can be managed centrally by the hospital IT with The access to sensitive areas is only possible with a modern, uniform system for user authentication. c e t a l E © little effort. This, along with the simple authentication processes for staff, increases the efficiency of clinics and helps to reduce costs. Similarly, RFID cards may be issued to patients, to facilitate cafeteria payments, access to enter- tainment programs and more, in an easy and convenient way. Sustainable and secure Universal readers are at the heart of modern access control systems. While hospital staff authenticate with cards, for example, patients can use their smartphones. To ensure that confidential informa- tion is protected, a reader that sup- ports advanced security protocols and encryption is also required. Furthermore, the reader's design must reflect the demands of a modern clinical environment, with an appealing aesthetic and the possibility for hygienic cleaning of the housing. Those in charge for the successful implementation of an access con- trol system should consider fur- ther important points beyond the choice of reader. For example, it is necessary to include the complete system in the hospital's security concepts in advance. Further cru- cial points are in the flexibility and future viability of the system. It should be compatible with exist- ing solutions, allow adaptations to changing requirements and be able to handle future technologies. Still, the system must be as user-friendly as possible to manage authori- zations. Given the complexity of these requirements, seeking advice from specialized solution providers is recommended in order to avoid bad investments. For example, Elatec GmbH, one of the world's leading providers of user authenti- cation and identification solutions, offers comprehensive consulting. Disinfection safely regulated The example of the American com- pany UV-Concepts shows how safety, flexibility and appearance requirements can be successfully met. The company specializes in innovative, non-contact disinfec- tion solutions, including a chamber that uses ultraviolet UV-C waves to kill germs on large items such as wheelchairs. To ensure disinfec- tion performance and avoid health hazards from UV-C rays, access to the equipment must be limited to trained personnel. To achieve this, UV-Concepts relies on Elatec's TWN4 Palon Compact Panel solu- tion. The reader features a durable, high-quality panel display and is compatible with up to 60 transpon- der technologies. Certified for sale in up to 110 countries worldwide, it offers exceptional flexibility. For example, the high level of compati- bility benefits hospital associations that use a range of different tech- nologies at their sites. In addition, activating new card technologies and updating firmware by remote configuration are easily possible. The reader is integrated into the UV chamber's digital tagging sys- tem and backend software, allow- ing for tracking of the time and trigger for each disinfection cycle. In this way, the reader contributes significantly to the correct appli- cation of the disinfection solution and protects patients and staff  alike. Sponsored • Fast-tracking research results into clinical practises Clinical evidence workflow solution The path from evidence-based research to clinical implementa- tion is straightforward in theory but taxing in practice: Research groups must be coordinated, rel- evant published material iden- tified, classified, and prepared, to shape findings into a compre- hensive SOP for clinical use. To facilitate this complex process, Wolters Kluwer developed a new suite of applications, called Ovid Synthesis. It streamlines research workflows and the implemen- tation of quality improvement measures into clinical practice. We spoke with Vikram Savkar, Senior Vice President & General Manager, Medicine Segment, Health Learning, Research & Practice, about the new solution, its development, and unexpected benefits for clinical education and onboarding. ‘We want to facilitate the process of continuous quality improvement, which is highly relevant for any hospital,’ he says. ‘Applying the best practice is essential for bet- ter clinical outcomes for patients and also benefits financial per- formance. But it can also be very tedious and time-consuming. With Ovid Synthesis, we have developed a workflow tool that helps make that process efficient, successful, collaborative and more accurate.’ Coordination of research groups is an enormous challenge, espe- cially in bigger institutions: teams are scattered and communication about ongoing projects often hap- pens in parallel over emails, offline documents and spreadsheets. ‘This is inefficient and makes it hard to find the relevant evidence,’ Savkar says. ‘Findings are challenging to share across teams in other depart- ments or hospitals. As a result, much time is wasted on research that has already been done before.’ To solve this, Ovid Synthesis offers a cloud-based space to conduct research activities, provides access to all relevant published evidence and ensures that all teams involved have visibility into current pro- jects in a comprehensive dash- board. ‘The system also allows teams to track previous unsuc- cessful research projects to avoid duplication of efforts.’ AI classification streamlines search for sources To accumulate relevant sources for research projects, the Synthesis solution is built upon the Ovid plat- form, which, according to Savkar, is the largest database of medical literature in the world. However, for teams searching for specific content, this wealth of information can be challenging to process: ‘Even the most accomplished and earnest researcher can’t possibly read all the articles that are pub- lished in a particular field,’ he says. ‘This is where our solution comes in – technology can help to make the selection and evaluation more efficient.’ To achieve this, Ovid Synthesis uses artificial intelligence (AI) to classify publications by their rele- vance. This is determined by scien- tific criteria, such as study design, sample size, or frequency of exter- nal citations. ‘If this were done manually, this classification alone may take up to an entire year, but our tools can reduce the process to a period of weeks.’ Only trained personnel can use the disinfection chambers. r e w u l K s r e t l o W © Not only does the system help pulling the relevant papers, but it also helps users extract their key insights and generates citation lists. ‘This process ensures that the tem- plate for any clinical improvement plan will be created in a rigorous, evidence-based way,’ Savkar stress- es. Originally intended as a tool to bring the latest evidence into clinical practice, the suite has also proven to be helpful in other, unexpected ways, Savkar reports: ‘We didn't build Ovid Synthesis as an educational or training tool. But the hospital systems we work with find that this is a very useful way to help residents and new doctors quickly assimilate to evi- dence-based practice culture in those hospitals. Because it is such a structured tool and it templatis- es the process of evidence-based practice, it helps teach them what that looks like.’ The process-oriented approach is also beneficial in creating greater job satisfaction for doctors and nurses, as user feedback shows: ‘They feel a sense of agency, that they can participate in a process to help improve clinical outcomes of their hospital. This is very mean- ingful for doctors and nurses, so it’s another by-product that we are thrilled about.’ Feedback loops fuel further development Ovid Synthesis launched in January 2022, after a two-year development phase. ‘We have worked closely with selected hospitals to make sure that all the innovation we put into this suite is driven by custom- er needs. We engaged many of our large hospital customers to help us design this so that it genuinely met their needs.’ Since the solution is cloud-based, it can be implement- ed into any pre-existing clinical IT infrastructure, says Savkar, adding that ‘cybersecurity is a top-level issue for us, so we implement the best practices to protect our cus- tomer’s data.’ Feedback loops are also to be a driver of the regular expansions to the suite, which are scheduled for release in six-month intervals; for example, a new institutional dash- board allowing users to identify and build on previously successful projects and automated integration with external research platforms. ‘So far, we have been very success- ful with this product; many major hospital systems adopted it on the first day it launched. The reason for this success is that we're choosing to take a steady customer-based path to building out the full solu-  tion over time.’ (WB) Vikram Savkar Vikram Savkar is the Senior Vice President and General Manager, Medicine Segment of the Health Learning, Research & Practice busi- ness at Wolters Kluwer. Previously, Mr Savkar served as General Manager for several businesses in the Legal & Regulatory division before join- ing the Health Division in late 2019. Prior to joining the company, he held senior positions at Nature Publishing Group and Pearson Education, and has earned degrees in Physics and Classics from Harvard University. EUROPEAN HOSPITAL Vol 31 Issue 2/22

2 0 I N F E C T I O N P R E V E N T I O N Antimicrobial resistance development AMR and climate change: a worrying dual threat to global health Climate change and antimicro- bial resistance (AMR) are form- ing an alarming alliance: Global warming creates new breeding grounds for resistant bacteria, which challenge human, animal, and environmental health sys- tems globally. A serious and very real threat to public health – but not quite the doomsday scenario some might make it out to be, says Prof Sabiha Essack from the University of KwaZulu-Natal in Durban, South Africa. ‘Antimicrobial resistance and cli- mate exacerbate each other,’ Prof Essack says. ‘Studies have shown that rising temperatures together with high population densities lead to higher AMR in bacteria – maps that show increases in tempera- ture correlate with areas where more resistant bacteria are found.’ Because the transfer of resistance genes is facilitated at higher tem- peratures, the bacteria can acquire and spread AMR genes more easi- ly. As global warming progresses, these high-risk areas become more common, creating new breeding grounds for resistant pathogens. Hunger for meat fuels AMR development The growing demand for meat protein and other animal products is another major driver of AMR, especially in low and middle-in- come countries. Animals are raised on a large scale, with regulations on antibiotic use not being very strict. The practice of prophylac- tic antibiotic supplementation of feed – which is cheaper than vac- cinating the animals – is especially problematic in this regard, Prof Essack points out. ‘Not only does this promote escalation of AMR, but the larger number of animals also leads to increased methane emissions, speeding up the green- house effect.’ Also, without proper preparation of the food produced from these animals, humans run risk of ingesting resistant bacteria themselves. Biosecurity is a key element to mitigate AMR in food animal pro- duction, the expert says: This con- cept includes the use of vaccines, establishing “all in/all out” sys- tems and thorough disinfection in production sites to prevent resist- ant pathogens from emerging and spreading from one herd or flock to another. Shifting from intensive to extensive and organic farming models may further reduce the need for antibiotics and the sub- sequent risk of AMR development. ‘This is more expensive, but it is a vital step to reduce AMR,’ she says. Emerging from origins hot and cold ‘Along with the rising tempera- tures, the ecosystems are chang- ing,’ Prof Essack continues. ‘This leads to floods, droughts, and other natural disasters. Microbes adapt and spread to new areas, as do insects that serve as vectors for new diseases. As a result, more antibiotics are used, increasing selective pressure on pathogens and thus promoting the develop- ment of AMR.’ However, global warming not only facilitates the development of new resistance but might also bring back old ones: ‘Climate change accelerates glacier melting and thawing of permafrost, which may contain antimicrobial resistance genes. Increased oceanic currents further help the spread of these AMR traits from Siberia and the Arctic to other parts of the world.’ For Prof Essack, the re-emergence of ancient resistant strains does not come as a surprise: ’Antimicrobial resistance has existed for millennia. It is our overuse and misuse that has severely tipped the balance and turned resistant pathogens into a significant global threat.’ Increasing health literacy without fearmongering To counteract the self-propagating effects of AMR and climate change, public awareness is essential, the expert says: ‘Antimicrobial resist- ance is a very intangible concept, so most people will not make the connection between the deaths from hospital infection and resist- ant pathogens.’ The main objec- tive for awareness campaigns is to clarify the consequences of AMR in an engaging way: ‘If we allow this development to continue, it will fundamentally change our healthcare standards. Many com- mon surgical procedures such as C-sections or implant surgeries will become impossible to perform, and untreatable infections will lead to premature death.’ Despite this, doomsday scenarios and fearmongering are not neces- sarily the way to go, Prof Essack believes: ‘We can achieve a lot with just little changes in our behaviour – sparing, prudent use of antibi- otics and running diagnostic tests to determine the type of pathogen before administering antibiotics – to ensure that our supply of effec- tive antibiotics do not run out.’ To further loosen our dependency on antibiotics, a number of inno- vative and promising approaches aim to not only develop new anti- biotics, but also antibiotic alterna- tives, such as bacteriophages. ‘Our arsenal of antibiotics is limited, not least because development of new antibiotics is not very profitable,’ the expert points out. To be pre- pared for the future, financial mod- els should be established to incen- tivise research and development of new antibiotics, independent from the current return-on-investment  model. Report: Wolfgang Behrends Sabiha Essack Professor Sabiha Essack, PhD, is Vice Chair of the WHO Strategic and Technical Advisory Group for Antimicrobial Resistance (STAG-AMR) and Advisor for several international initiatives on antimicrobial resistance. She further serves as expert consult- ant on antimicrobial resistance (AMR) and antimicrobial stewardship (AMS) to the WHO. Professor Essack’s current research interests include evidence-in- formed strategies for the prevention and containment of antibiotic resist- ance, characterization of the molec- ular epidemiology of resistance in humans, food animals and their asso- ciated environments, as well as health policy and health systems strengthen- ing to optimise the management of infections in the context of antibiotic resistance and stewardship. Drug dose optimisation Antibiotics: no more ‘dosing in the dark’ Antibiotics are essential for keep- ing bacterial infections in check, but finding the right dose is akin to a Goldilocks problem: give too little, and the infection will per- sist; too much, and side-effects will override the benefits of the therapy. To get it “just right”, Prof Dr Birgit Koch talked about dosing optimisation in the clini- cal setting at this year’s ECCMID in Lisbon. We spoke with the Clinical Pharmacologist from Erasmus MC, Rotterdam, about the shortcomings of current methods and the benefits of patient-tailored dosing. ‘The concept of “a lot helps a lot” clearly does not apply,’ the expert points out: ‘The higher the dose is, the more the toxicity of a drug becomes an issue.’ Furthermore, incorrect dosage encourages resist- ance-building in pathogens, and excessive prescription is not a sustainable, cost-effective practice. ‘This is why dose optimisation is so important.’ But getting the dosage of antibi- otics right is a challenging matter, Prof Koch says: ‘There is a range of factors that play a role. As a rule of thumb, anything that affects a patient’s metabolic function should be considered, so the most impor- tant parameters are age, gender, and renal function.’ Albumin levels in the blood are also relevant, as are pre-existing conditions and medication. Lastly, the type of tar- geted microorganism should be considered. Models in need of greater diversity Limited knowledge about a drug’s pharmacokinetic (PK) and phar- macodynamic (PD) properties can add another layer of difficulty: ‘Unfortunately, no PK/PD models exist for most drugs developed before 1995,’ Koch reports. This includes antibiotics that are still in widespread use, such as amox- icillin. But even for newer drugs, PK/PD models often lack heter- ogeneity in patient data. ‘A lot of times, references are only based on effects in young male persons.’ As a result, most patients receive the same antibiotic dosage – regardless of individual risk fac- tors. ‘We have discovered that for some beta-lactam antibiotics, most patients receive the same dose, but only 60% achieve site exposure,’ the pharmacologist states. In other words, the drug does not reach its target in the intended quantity. To establish more nuanced dosage models, researchers at Erasmus MC took a closer look at the blood of patients in the centre’s ICU. The team gained insights into how drugs were metabolised by differ- ent patient groups. ‘For example, impairment of renal function – due to advanced age or disease – affects the rate in which a drug is cleared from the blood,’ Koch reports. ‘We identified several of these risk factors for target non-at- tainment, so patients with these risk factors need to receive an adjusted antibiotic dose.’ AI to create more detailed connections While the benefits of individu- alised drug dosing might seem rather self-evident, scientific evalu- ation of the concept is surprising- ly sparse. The recently completed DOLPHIN trial is an effort to pro- vide evidence and encourage clin- ical application of patient-tailored dose models, the expert says. In the Dutch multicentre, prospec- tive, randomised study, outcomes were compared between critical- ly ill patients whose medication dose was monitored and adjusted to reflect individual factors and patients who received the standard dosage. ‘We hope that we will see more model informed precision dosing arrive in the clinical prac- tice in the future,’ says Prof Koch, who presented the findings of the trial at the ECCMID congress. The expert also regards AI as a key technology. ‘What is especially promising is that algorithms are not biased the way humans are. Because the AI will only process the raw data without knowing the context, it may establish correla- tions and identify risk factors that a human would have missed.’ Prof Koch also advertises the practice of infection site measurement, which should replace current blood analysis to ensure more targeted results. ‘We still have a lot of work to do,’ she concludes, ‘but getting the right drug in the right dose to the right patient could solve a lot of our current problems, so it’s clearly worth the effort.’  Report: Wolfgang Behrends Birgit Koch Prof Dr Birgit Koch is a Clinical Pharmacologist and Full Professor of Clinical Pharmacometrics at the Erasmus University Medical Center, Rotterdam, the Netherlands. She focu- ses on Therapeutic Drug Monitoring (TDM), PK/PD and Toxicology and is also part of the management team of the pharmacy. The laboratory cov- ers more than 70.000 TDM/toxicolo- gy samples per year and more than 100 assays, both in clinical care and in research. Since January 2020, Prof Koch is head of Research & Teaching of Pharmacy Erasmus MC. EUROPEAN HOSPITAL Vol 31 Issue 2/22