The COVID-19 pandemic continues to dominate since the worldwide lockdowns that were implemented in March 2020. The resulting health situations have progressed through numerous stages. The UAE has taken unprecedented precautionary measures, including complete lockdowns against COVID-19 to control its spread and ensure the well-being of individuals. Guidance on infection control and use of personal protective equipment was provided.

The major clinical tools used in the diagnosis of patients presenting with respiratory distress and suspected COVID-19 symptoms are radiology examinations. Along with the patient’s clinical history and blood biomarkers, radiological investigations play an important role in the identification of COVID-19 respiratory symptoms. Chest X-ray and computed tomography (CT) have an important role in the management of patients with respiratory distress and COVID-19 symptoms. 

Related: The 2021 Medical Imaging Report

Radiologists, radiographers and radiology nurses, are part of the front-line healthcare professionals combating COVID-19. Most of the workers come into physical contact with patients during radiological examinations. In the Middle East, the workload in the radiology department increased due to pressure on general x-ray and CT, and also decreased in other modalities due to adherence to national and international guidance to minimise non-essential examinations. On the other hand, portable X-ray increased to reduce disease transmission, and in-department examination has declined. The reported decline and increase in workload are similar to other reports from North America, Africa and Europe.

Radiology workers faced unique experience while delivering radiological services during this unprecedented time. They have dedicated to providing patient care service, supporting patient safety and promoting the well-being of others despite the impact on their health. Fear, anxiety, panic attacks, sleep, eating disorders and suicide have been reported among healthcare providers during previous pandemics. Similar findings were reported during the COVID-19 pandemic, with a heightened risk for mental health problems among healthcare professionals who were in direct contact with confirmed or suspected COVID-19 cases.

Related: Mental health and COVID-19: How are we coping?

Radiology workers reported adequate availability of personal protective equipment, were afraid of becoming infected at work. Healthcare professionals involved in the care of COVID-19 patients should undergo regular evaluations of stress, depression, and anxiety levels to support their well-being. Similarly, radiology workers suggested the need for professional support to deal with stress during the COVID-19 pandemic. It is the requirement of creating awareness of the need for professional support amongst the radiology workers in coping with stress, anxiety and other psychological disorders that might arise during the COVID-19 pandemic and similar crises.

In the Middle East, radiology workers reported adequate availability of personal protective equipment; however, 56.9 per cent were scared to be infected with COVID-19. China reported higher percentages, as 85 per cent of healthcare professionals were afraid of the COVID-19 infection. The COVID-19 pandemic has become a significant stressor to medical professionals, and studies in China indicated high levels of stress, depression, and anxiety. It is extremely important to support mental and physical health during the current pandemic and prepare an emergency plan for future similar incidents.

Studies reported that healthcare workers, especially the front-line staff, who were involved in handling patients infected or suspected to be infected with COVID-19 are at greater risk of stress and anxiety than other medical workers. The psychological outcomes of these workers can be due to many reasons such as increased workload, long working hours, use of personal protective equipment, and social media news. Infections among colleagues and family members increased the risk of developing anxiety, depression and stress among health care providers. It is imperative to establish clear directives, initiate precautionary measures, provide informed health interventions, obtain support from family, and increase the productivity of the radiology workers in preparation for both current and future outbreaks.

Dr. Wiam Elshami

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Patient shielding was used from the last 70 years, however, recent literature revealed new approaches. Shielding can be constituted by different materials with diverse atomic number. Lead is the most traditional, nevertheless bismuth and barium had been widely used on the last decades.

According to the use, patient shielding can be divided taking into account the acquisition plane (in-plane and out-of-plane) and the patient contact (with and without). Some particular shielding is more frequently used in specific modalities or examinations with the aim of dose reduction in radiosensitive organs.

Related: AI has arrived in medical imaging

On the last 40 years, no hereditary effects from ionising radiation of medical imaging procedures have been observed, examination doses reduced and consequently the gonads exposure reduced significantly. And the radiological equipment technical evolution also provided modern systems that strongly decreased the radiation levels outside the Field of View (FOV).

The use of shielding can also be controversial considering that in-plane shielding can block anatomical information and increase the radiation dose levels if the automatic exposure control (AEC) is used. Out-of-plane shielding impact is described as irrelevant by some authors, taking into account that most of the radiation comes from the scatter inside body.

Related: The 2021 Medical Imaging Report

The chances of repeat the exposure are also described as a concern. However, this fact also depends on patient collaboration and radiographer training. Exclusively paediatric radiographers are more trained to use shielding than the ones that works in a mix centre, with adult and paediatric patients.

Conventionally paediatric procedures involved patient shielding, however in 2015 Eurosafe Imaging recommended to avoid the use of gonadal shielding, for female paediatric patients, considering the ovaries positioning out of shielding area and the dose increase caused by AEC use. On this “Ask Eurosafe Imaging tips and tricks” document is suggested that out-of-plane shielding can be used for male paediatric patients.

More recently, in 2020, Eurosafe Imaging presented a review of patient shielding use recommendations on the European countries. Some countries do not recommend the use of bismuth shielding, as for example Norway. German Commission on Radiological Protection indicates that some computed tomography procedures may include out-of-plane shielding.

Some countries already provide documents to guide the use of patient shielding for diagnostic radiology applications. In the majority of situations shielding is not recommended. A list of a few exceptions is presented: particular patient care pathway, number of repeat examinations, high examination frequency in paediatric patients and a multidisciplinary decision after a patient request.

Image Wisely Campaign, from United States of America, provided some frequently ask questions (FAQs) about gonadal and foetal shielding in order to help professionals decisions and avoid the shielding use.

In our days new studies about patient shielding are still presented, however, more research is needed mainly about out-plane shielding without patient contact.

Actually, a large variation of procedures is present across the countries. Despite some countries presenting different guidance, a few countries don’t have new recommendations and the lack of norms harmonisation and guidelines hinders radiographers’ decisions.

According to Basic Safety Standards, radiographers are involved on benefits and risk patient communication, associated with radiation dose from medical exposure. Radiographers are in direct contact with the patients and the majority of them considering that the use of shielding in each procedure is a radiographer’s decision, must be to lower patient risk.

Is also relevant to be aware, that patients are used to the shielding, especially in paediatric procedures. Based on this, strategies to promote patient/tutor engagement to change the practices are crucial, in order to decrease the patient risk and maintain the confidence on radiography professionals.

The radiographer’s education and training guidelines, presented on “Radiation Protection Report nº 175, from European Commission” and on “European Qualification Framework (EQF), Level 6 Benchmarking Document: Radiographer” from, European Federation of Radiographer Societies, include patient shielding on the learning outcomes (described in knowledge, skills and competences). During the graduation course all the European radiographers learned how to use shielding and a large percentage increased their training on the daily practice or in specific continuing professional development (CPD).

The decision of shield, or not shield, is based in optimised procedures. However, worldwide different levels of radiation exposure optimisation are present. Dose reduction strongly depends on the examination device, the examination technique and the patient situation.

Recommendations must be harmonised in order to change undergraduate radiographer’s education and training, and radiographers CPD, to adapt the practices according to the norms and best practices.

If the technological devices evolve, the practices should be adapted in order to promote patient comfort and engagement without increasing risk.

Dr Joana Santos

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Artificial Intelligence (AI) is an innovative and potentially transformational tool in Radiology and diagnostics in general. The adoption and implementation of AI solutions within medicine has accelerated in recent years, with AI most commonly serving in a complementary role to the clinical workflow in order to expedite routine and well-defined processes.

These processes typically function as a clinical decision support system referred to as computer-aided detection (CADe) or computer-aided diagnosis (CADx). However, with the development of more complex deep-learning algorithms such as convolutional neural networks (CNN’s), AI has the potential to match or exceed human performance in domains involving vast amounts of information processing and synthesis. Given the profound and wide-ranging implications of AI implementation in healthcare, a foundational knowledge of AI is necessary for all pertinent provider domains. In this article, we will discuss the importance of AI systems and expound on current and impending utilisation of AI for Radiology and diagnostics.

Demand for AI in healthcare

Related: The 2021 Medical Imaging Report

The demand for radiologic diagnostics continues to grow and currently outpaces the growth of the Radiology workforce. For example, the Clinical Radiology UK Workforce Census 2020 Executive Summary estimated that the demand for complex imaging studies (CT, MRI) is increasing at a rate of 7 per cent per year while the Clinical Radiology consultant workforce is growing at a rate of 4 per cent per year. The same 2020 Executive Summary from the UK estimated that over 200,000 patients waited six weeks or more for a CT or MRI scan in September 2020, a number ten times greater than the year prior.

The COVID-19 pandemic has also created a backlog of patients requiring imaging studies. Part of this backlog is attributable to a sharp decline in utilisation of oncologic screening studies, with one study estimating a deficit of over nine million studies for prostate, breast, and colorectal cancer in the U.S. alone. The adoption and implementation of AI in Radiology has the potential to significantly alleviate this burden and could pave the way to more timely imaging and diagnosis for many patients.

Related: How post-COVID radiology will be shaped by data-driven insights powered by AI

In 2020, the ACR Data Science Institute Artificial Intelligence Survey showed that approximately 30 per cent of radiologists currently use AI in clinical practice, with more planning to purchase AI tools within the next five years. The survey found that large practices are more likely than small practices to use AI, and that the most common current usage of AI is for detection of intracranial haemorrhage, pulmonary emboli, or mammographic abnormalities. These AI applications are primarily clinical decision support systems (CADe, CADx) designed to supplement and expedite the workflow of a human diagnostician.

Established AI use cases

One of the more established use cases for AI in diagnostics is the in the detection of diabetic retinopathy on images of the retinal fundus. In one study, a CNN was developed and trained on over 12,000 images. This algorithm was able to achieve over 98 per cent specificity and approximately 90 per cent sensitivity as verified by practicing ophthalmologists. In another example, a deep learning algorithm was successfully developed and trained on over 14,000 three-dimensional optical coherence tomography (OCT) scans to make referral recommendations regarding range-of-sight threatening retinal diseases such as diabetic retinopathy which meet or exceed those of experts. In 2018, the FDA approved and granted Breakthrough Device designation to an AI system designed to detect diabetic retinopathy.

Breast cancer screening is an established but evolving use case for AI. CADe systems have been used for detecting mammographic abnormalities since as early as 1998 and have since become reimbursable through the Center for Medicare and Medicaid Services (CMS). Studies of CAD applied to mammography initially yielded mixed results with respect to accuracy and reading times. More recent studies with deep learning algorithms, however, have been much more promising. For example, in one study from University of Pennsylvania, a deep learning AI system was applied to digital breast tomosynthesis (DBT) breast screening studies with encouraging results including a 52.7 per cent decrease in reading time, an 8.0 per cent increase in sensitivity, and a 6.9 per cent increase in specificity as compared to radiologist performance without AI. Given these results and those from other similar studies involving deep learning, there is likely a substantially greater benefit in terms of accuracy and workflow optimisation from using more modern and sophisticated AI systems to assist with breast cancer screening.

Given that lung cancer is the most common cause of cancer-related death in the U.S., improvements in screening processes are crucial. For this reason, lung nodule screening with CT is another area in which AI has been implemented and shown positive results. One study used a deep learning algorithm to achieve exceptional CT screening performance with an area under the curve of 94.4 per cent. The deep learning algorithm performed at least as well as experienced radiologists in a direct comparison.

Transformative AI use cases

Recently, AI has been applied to the diagnosis and prognostication of COVID-19. Use cases involving COVID-19 have been particularly important due to overwhelming strains on medical infrastructure caused by an unprecedented volume of patients. In one study out of Stanford, a CNN was developed to detect COVID-19 on chest CT without any special image processing. This CNN is expected to additionally enable prognostication by tracking image features over time on sequential scans.

In another example, a deep learning model was developed to output biomarkers derived from CT scans from institutions around the world. These derived biomarkers were then utilised with electronic health record (EHR) data for prognosis analysis to identify predictors for patient severity outcomes.

Barriers to AI implementation

Despite the potential of AI to transform healthcare, there are many pertinent issues which are slowing or preventing more rapid and widespread adoption. One of the most pressing issues is how to regulate AI in an accountable, fair, and transparent manner while implementing it for complex and risk-intensive processes. As explained by Corinne Cath, AI regulation can be approached from an ethical, technical, or legal-regulatory perspective. There are various concerns regarding each of these approaches, and the concerns are often overlapping. The ideal regulatory framework will likely require a multidisciplinary effort that adequately address concerns around data privacy, accuracy, patient safety and medico-legal implications.

Within the legal-regulatory sphere, questions arise regarding the appropriate scope of legal policies surrounding AI as well as which entity or entities ought to be responsible for implementing and enforcing said policies. There exist significant accountability challenges due to the notion that AI and especially deep learning algorithms such as neural networks are “black box” systems which defy traditional conceptualisation and explanation. Individual errors or more large-scale discriminatory patterns may result from use of AI for which it will be difficult to assign liability in the absence of a fundamental understanding of the underlying mechanisms resulting in error.

Financial considerations

Currently, reimbursement for AI by the U.S. Center for Medicare and Medicaid Services (CMS) is limited to use in mammography. Additional uses of AI software deemed reimbursable by CMS will likely depend on evidence showing significant improvements in diagnostic accuracy and operational efficiency. For now, healthcare systems must assess the potential for AI to impact operational efficiency in order to evaluate potential cost-savings.

According to a recent analysis by Gartner, the AI investment landscape appears positive. This analysis indicates that, in 2020, 47 per cent of AI investments were unchanged and 30 per cent of organisations planning to increase their AI investments despite the impact of the COVID-19 pandemic.

The hype cycle for AI in 2020 showed a few new AI trends debuting on the Gartner Hype Cycle, including generative AI, composite AI, and responsible AI. Most AI trends reside near the Peak of Inflated Expectations, with AI as a general concept felt to be rolling off the Peak of Inflated Expectations as it begins to deliver on its potential by providing benefits for businesses.

Future of AI

The perceived lack of trustworthiness in current AI systems is related to the nature of complex AI algorithms as potentially unexplainable, a notion which confers significant reluctance to accepting and utilising the output generated by AI. To address this concern, developments are being made in the field of Explainable AI (XAI). One XAI study performed on the Heart Disease Dataset from UCI showed multiple approaches to generating XAI, including feature-based techniques showing how much input features contribute to model output as well as example-based techniques showing how much individual instances contribute to a model’s output.

Over time, AI algorithms, not only in radiology but healthcare generally, are bound to establish a key niche and find broader acceptance helping impact workflow efficiencies, safety, quality access and cost partly through automation of low-level tasks, better data organisation and contextualising insights. In order for society to realise this technology’s full potential commensurate regulatory, medico-legal and payment reform will be key.

Reference available on request.

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Medical imaging technology is characterised by continuous rapid changes and developments. Medical imaging is used extensively in the diagnosis, monitoring, and treatment of patient medical conditions. Medical imaging refers to a range of imaging technologies such as projection radiography, computerised tomography (CT), Magnetic resonance imaging (MRI), ultrasound (US) and others, which are used to provide information about the morphology (anatomy) and physiology (function) of the human body. (Figures 1 to 4)

Related: The 2021 Medical Imaging Report

Figure 1: Conventional radiography (X-rays)

The quality of the image is often assessed as how reliably the image represents the anatomy or the pathology being imaged and has a direct impact on the patient’s diagnosis and/or treatment. Suboptimal images may lead to misdiagnosis, incorrect treatment delivery, and necessitate a repeat of the image. Repeat images result in an unnecessary risk to the patient. All imaging technologies have an element of risk. Projection radiography and CT have the risks associated with the use of ionising radiation, which include both stochastic and non-stochastic effects. MRI uses magnetic fields and electromagnetic frequencies and their associated risks. US makes use of high frequency sound waves which produce a heating effect and potential cavitation in tissues.

Related: How post-COVID radiology will be shaped by data-driven insights powered by AI

Figure 2: Computerised tomography (CT)

Producing high quality medical images is important for image interpretation to obtain the maximum diagnostic information and to be able to visualise discrete changes in anatomy indicating early pathological processes. Higher quality medical images normally imply higher radiation dose or risks to patients since changes in exposure or scan parameters to this effect often increase radiation dose or associated imaging risks.

Figure 3: Positron emission tomography (PET) CT

Figure 4: Ultrasound (US)

Optimisation: Limitation of risks

In the case of imaging modalities using ionising radiation, reference doses serve as an indication of doses which are considered higher than would normally be expected for standard radiographic practice. Applying this concept helps radiologists and radiographers to identify and optimise those imaging protocols, which provide unusually high patient doses. Focusing dose reduction strategies on those centres or radiological examinations yielding higher radiation doses than the established norm is an efficient method of reducing radiation dose to patients. The establishment of reference doses is an important step towards the optimisation of patient doses. Publications 60 and 73 of the International Commission on Radiological Protection (ICRP) replaced the term reference dose with dose reference levels (DRLs). The concept of reference doses was then adopted by the European Union (EU) in its Medical Exposure Directive (MED) in 1997 and again in the Basic Safety Standards Directive of 2014 as diagnostic reference levels (DRLs), requiring all member states to promote the establishment and use of DRLs. The establishment of DRLs assesses and compares the radiation dose in performing clinical diagnostic examinations with the dose given in other national and international institutions. DRLs should be reviewed at certain time intervals to determine whether radiation dose optimisation is adequate or whether corrective action is required. DRL comparative assessment is performed for similar sized patients undergoing the same clinical examinations. DRLs are not there to compare individual patient doses but to compare average patient doses for a given examination in a particular hospital. DRLs are recommended for those radiological examinations, which are more frequently requested or those involving a higher radiation dose.

EU directives require the establishment of DRLs in medical imaging using dose quantities that are simple to obtain and which take scan parameters into account. Dose quantities should be applicable to all current and new types of imaging technologies. Radiation dose descriptors need to be consistent with other reference doses and dose descriptors already in use allowing comparison of the radiation doses in different imaging centres and with radiation doses from other diagnostic imaging examinations.

The criteria for radiation dose to the patient given for each projection radiography examination is expressed in the European Guidelines in terms of a reference value of the Entrance Surface Dose (ESD) for a standardised sized patient. Volume CT dose index (CTDIvol) and dose length product (DLP) have been proposed in the European Guidelines as appropriate dose quantities for the establishment of DRLs in CT. CTDIvol represents the average dose within a scan volume relative to a standardised CT phantom. CTDIvol is not the dose specific to the patient but a standardised index of the average dose delivered from the scanning series. A complete CT examination consists of several scans through the anatomical region. A longer scan length employs a greater number of slices and longer anatomical length. The CTDIvol multiplied by the total scan length in centimetres is given as the dose length product (DLP) given in milligray-cm (mGy-cm). Monitoring of DLP provides control on the volume of irradiation and overall exposure for a CT examination.

DRLs do not signify an optimum performance and reduction of radiation doses below the DRLs should always be pursued in line with ALARA, but with due attention to the potential loss of clinical information with any radiation dose reduction.

Optimisation: Diagnostic image quality

The standard of image quality in medical imaging mainly depends on the preferences and requirements of the reporting radiologists. Radiologists may opt for aesthetically pleasing low noise, high quality medical images and may be reluctant to reduce radiation dose or imaging risks. This potential for subjectivity increases the possibility of producing medical images that may exceed the clinical requirement for adequate diagnosis and hence the need for optimisation in keeping radiation doses as low as reasonably achievable, commensturate with the medical purpose. Hence the need for a keen understanding of image quality evaluation tools so that we can recognise good image quality to be able to balance this with low radiation dose or imaging risks. Low radiation dose and low imaging risks should be optimised in a way that is consistent with image quality to ensure that the radiation dose and imaging risk is ‘as low as reasonably achievable below the appropriate dose/risk constraints, with economic and social factors being considered’. Effective and scientifically accepted methods of assessing image quality are needed for the implementation of such optimised imaging protocols.

The important question here is, how can we ensure acceptable image quality while remaining confident in our diagnosis, using the lowest possible radiation dose or imaging risks?

The aim of image quality review during radiation dose or imaging risk reduction experimentation should, therefore, be to provide an image that is suitable for the clinical task and able to deliver sufficient information to the radiologist permitting a medical decision to be taken with an acceptable amount of assurance with the lowest radiation dose or imaging risks to the patient. Investigating new methods for radiation dose and imaging risk reduction in medical imaging have always been a priority and part of the fundamental principle of optimisation. Often simple low-cost measures are available to reduce radiation doses and imaging risks without loss of diagnostic information. Studies performed to investigate the effect of measures in reducing radiation dose and imaging risks and their effect on image quality have either tackled specific exposure or scan parameters individually or measured the effect on image quality by using phantoms. However, phantom studies alone may not necessarily reflect the true quality characteristics of the medical image in representing anatomical structures.

Evaluation of anatomical criteria such as the ones outlined in the European Commission’s documents: EUR 16260 and EUR 16262, consider both the anatomy of the area under examination and the physical image criteria including structures to be clearly visualised and discriminated reflecting contrast differences between tissues essential for the detection of pathologies. The underlying assumption in the use of these criteria is that if normal anatomy is faithfully reproduced then pathology will also be demonstrated.

To limit any uncertainties in interpretation, observer performance tests on optimised medical images should be carried out testing visualisation of anatomical structures or known pathologies. Observer performance methods such as image criteria (IC) studies, visual grading analysis (VGA) and receiver operating characteristic (ROC) analysis are established methods for the analysis of image quality. IC and VGA are useful in most cases where patient examinations present as normal anatomy. ROC is of value in determining whether a specific technique or technology is sufficient for identification of specific known pathologies. ROC is not always feasible, as obtaining an image database of sufficient size containing pathologies of varying subtlety may be difficult.

Conclusion

Adherence to diagnostic requirements for each radiographic examination will ensure that diagnostic effectiveness does not suffer from implemented optimisation strategies.

 References available on request

Dr Francis Zarb

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Throughout the pandemic, the focus has deservedly been placed upon the safety of the entire global population. However, at the same time, there has been another unseen threat posed to the safety of the healthcare industry during the pandemic. Primary Source Verification provider, TrueProfile.io, reveals that the rate of employment fraud uncovered by their diligent verification team has risen by 30 per cent during the ongoing pandemic period.

TrueProfile.io is part of the DataFlow Group, a global provider of specialised PSV solutions, background screening and immigration compliance services which bears the responsibility of verifying the credentials of healthcare workers within the GCC. By assessing its global database of verification applicants, the increased fraud rates were discovered, and the insights also revealed that overall fraud rates, which refers to fraud on any verified documents including degrees, ID, employment certificates, licenses, throughout the pandemic also increased by 15 per cent when compared to the same period last year.

Related: Combatting document fraud

René Seifert, Co-Head of TrueProfile.io, explains: “These worrying figures highlight that there’s never been a more urgent need for healthcare professionals to be properly vetted during the application stage to ensure they truly have the qualifications they claim to have in the application stage. It’s particularly concerning to see that the area people tend to embellish the most is in relation to their previous employment by tweaking their title, responsibilities or adding extra years of experience to try to get the edge over other candidates.

“The pandemic has caused an increase in unemployment rates. Additionally, the increase in online learning, working from home and access to the internet allows diploma mills – an unregulated institution of higher education granting degrees with few or no academic requirements – to flourish. Together, these conditions mean that fraudulent applications can thrive, and it’s becoming more difficult for employers to detect them.”

Related: How COVID-19 transformed healthcare recruitment

He adds, “For employers in high-risk sectors such as healthcare, hiring an unqualified candidate can literally be the difference between life and death, so it’s critical that organisations implement processes to evade this and protect both themselves as well as their patients or customers.”

TrueProfile.io safeguards businesses against fraudulent candidates with false credentials by carrying out pre-employment checks to the highest standards to ensure compliance. By providing a technology-driven platform that connects international employers with trusted professionals, TrueProfile.io ensures that an applicant’s credentials have been verified at the source. This trusted environment allows businesses to mitigate risk and save time by making informed decisions about the individuals they choose to work with. TrueProfile.io also offers a verified recruiting service via a tool known as TrueProfile.io Recruiting, where employers can search hundreds of thousands of pre-verified candidates to find an employee with the right skills and experience. 

René concludes: “The increase in employment fraud rates means that employers, regulators and recruiters need to act now to ensure that they don’t fall victim to fraudulent candidates. Ensure that a stringent recruitment process is in place to protect your business and the entire community that it operates within.”

For more information about TrueProfile.io’s verification services visit: www.trueprofile.io/ or email businesspartner@trueprofile.io

René Seifert

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

At a time when COVID-19 has proven how quickly a deadly pathogen can travel across the globe, Cleveland Clinic has significantly expanded its global commitment to infectious disease research and translational programs to form the Global Center for Pathogen Research & Human Health.

The new center positions Cleveland Clinic as an international leader for research into emerging pathogens and virus-related diseases.

Related: Cleveland Clinic unveils top 10 medical innovations for 2021

“This is the largest research effort in Cleveland Clinic’s 100-year history,” said Cleveland Clinic CEO and President Tom Mihaljevic, M.D. “The Global Center for Pathogen Research & Human Health will put Cleveland Clinic at the forefront of pathogen research and preparing for the next pandemic or healthcare crisis. The center will have a significant impact on global health.”

Headquartered in Cleveland and spanning Cleveland Clinic’s international footprint in Florida, London and Abu Dhabi, the Global Center for Pathogen Research & Human Health brings together a research team focused on broadening understanding of viral pathogens, virus-induced cancers, genomics, immunology and immunotherapies. It expands upon Cleveland Clinic’s existing programs and expertise, with newly recruited world leaders in immunology, cancer biology, immune-oncology and pathogen research as well as technology development and education. Researchers are expanding critical work on studying, preparing and protecting against public health threats such as HIV/AIDS, Dengue fever, Zika and COVID-19.

Related: Interhospital transport of patients with COVID-19: Cleveland Clinic approach

Cleveland Clinic, with its world-wide clinical and research operations, top scientists and physicians, medical educational programs and international funding, is uniquely positioned to be a global hub for state-of-the-art pathogen research, clinical care and serving as an incubator for rapid development, testing and deployment of diagnostics, medicines and vaccines. The Center is organized around six highly collaborative programs with multidisciplinary experts in virology and immunology; personalized medicine and genomics; population health; drug discovery; diagnostic development and integration of big data with patient care.

The center is led by Jae Jung, Ph.D., an internationally renowned expert in virology and virus-induced cancers who has broken ground in the field of inflammation, immune-oncology and emerging pathogens. This team plans the recruitment of more than 300 scientists in the next 5 to 7 years.

“The Global Center for Pathogen Research & Human Health will be a command center to help solve deadly threats to our health, economy and communities,” said Serpil Erzurum, M.D., Cleveland Clinic’s Chief Research and Academic Officer. “The unparalleled investment in the Center will drive workforce development while leveraging Cleveland Clinic’s research infrastructure to study pathogens and the immune system in novel ways to develop new diagnostic tests, vaccines and treatments.”

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Indirect immunofluorescence (IIF) is an important screening method for laboratory diagnostics due to its high sensitivity and specificity together with its broad antigenic spectrum. However, the microscopic evaluation of the fluorescence patterns is time-consuming and challenging for laboratory staff. Nowadays, many laboratories use automated systems to facilitate and standardise the IIF readout and interpretation. Automated microscopy systems enable fast digital acquisition of immunofluorescence images, as well as reliable result evaluation encompassing discrimination of positive and negative samples, pattern classification for key autoantibodies, and titer designations. New state-of-the-art systems incorporate artificial intelligence (AI) based on deep learning methods for classification of the immunofluorescence patterns and calculation of the antibody titer. The advent of live microscopy, whereby the evaluation is performed completely on-screen, provides a new level of speed and convenience for IIF diagnostics, as well as high standardisation between microscopes and operators. Automated IIF result interpretation is particularly useful for autoimmune serological applications such as detection of anti-nuclear antibodies (ANA) on human epithelial (HEp-2) cells, anti-neutrophil granulocyte cytoplasm antibodies (ANCA) on granulocytes, or anti-double-stranded DNA (dsDNA) antibodies on Crithidia luciliae.

ANA

ANA represent a key diagnostic criterion for many autoimmune diseases, especially rheumatic diseases such as systemic lupus erythematosus (SLE), mixed connective tissue disease, Sjögren’s syndrome, systemic sclerosis and poly/dermatomyositis. The gold standard for ANA determination is IIF on HEp-2 cells. This substrate provides the complete antigen spectrum and allows investigation of over 100 different autoantibodies. Positive results from IIF are confirmed using monospecific tests such as ELISA, chemiluminescence immunoassays (ChLIA), immunoblot or IIF microdot assays.

Related: Comprehensive analysis of SARS-CoV-2 immune responses

Identification of the fluorescence pattern on HEp-2 cells enables classification of the antibody or antibodies present in the patient sample. The International Consensus on Antinuclear Antibody (ANA) Patterns (ICAP, www.anapatterns.org) has developed a classification tree of patterns, with each assigned an anti-cell (AC) code number, to harmonise reporting between laboratories.

The evaluation of ANA on HEp-2 cells can be simplified and standardised using computer-aided microscopy systems, with those based on artificial intelligence providing the highest proficiency. The EUROPattern system, for example, uses deep convolutional neural networks to provide highly reliable differentiation of positive and negative ANA results, as well as identification of nine ANA patterns according to ICAP, namely homogeneous (AC-1), speckled (AC-4, 5 29), dense fine-speckled (AC-2), nucleolar (AC-8, 9, 10), nuclear dots (AC-6, 7), centromere (AC-3), nuclear envelope (AC-11, 12), anti-mitochondrial antibodies (AMA, AC-21), and cytoplasmic (AC-15 to 23). The deep learning algorithms ensure efficient segmentation of the HEp-2 cells, that is detection of their location and shape, so that counterstaining of the cells is no longer necessary. Both interface and mitotic cells are reliably identified. The automatic classifier generates pattern and titer suggestions with confidence values, including for mixed patterns, which occur where more than one antibody is present in the sample. For each pattern the titer is automatically calculated from the fluorescence intensities of the incubated dilutions, ensuring reproducible results.

Related: Euroimmun Webinar: Dermatomycoses – Diagnostic challenges

To investigate the diagnostic accuracy of the automated procedure, IIF evaluation using the EUROPattern classifier was compared to conventional visual interpretation using 213 patient sera. The overall agreement for positive/negative discrimination amounted to 93.0%. In the pattern assignment the agreement ranged from 90.1% to 100% for the different nuclear patterns, and 85.4% to 99.5% for the cytoplasmic patterns.

Anti-dsDNA antibodies

Anti-dsDNA antibodies are a hallmark of SLE and represent an important criterion for diagnosis. Their prevalence in SLE ranges from 20% to 90% in different studies, depending among other things on the test method used and the disease activity. Like the gold standard Farr assay, IIF using Crithidia luciliae as the substrate (CLIFT) is considered to have a very high disease specificity. The method takes advantage of the kinetoplast of Crithidia luciliae, which is rich in DNA but contains hardly any other antigens, thus enabling highly selective detection of anti-dsDNA antibodies. Automated evaluation of the fluorescence signals increases the reliability of the results compared to manual reading, which is subjective and leads to high intra- and inter-laboratory variation.

Interpretation of CLIFT is incorporated into the EUROPattern system. The sophisticated software is able to recognise the organelles of the protozoan and evaluates the specific kinetoplast fluorescence rather than just dark-light classification, ensuring high result reliability. Results are classified as positive or negative depending on the kinetoplast fluorescence, and include a titer designation based on the fluorescence intensity for positive samples. In a comparison of automated and visual evaluation of Crithidia luciliae IIF using 83 sera, the agreement between the two methods was 97.6%.

ANCA

ANCA are important serological markers for diagnosis and differentiation of autoimmune vasculitides, especially granulomatosis with polyangiitis (GPA, formally known as Wegener’s granulomatosis), which is characterised by autoantibodies against proteinase 3 (PR3), and microscopic polyangiitis (MPA), which is typified by autoantibodies against myeloperoxidase (MPO). In addition, ANCA can be found in chronic inflammatory bowel diseases. ANCA are detected by IIF with confirmation using monospecific assays.

The IIF substrates ethanol-fixed and formalin-fixed granulocytes are used to identify the typical ANCA staining patterns of anti-PR3 (cytoplasmic, cANCA) and anti-MPO (perinuclear, pANCA) antibodies. An additional substrate consisting of HEp-2 cells coated with granulocytes allows immediate differentiation between ANCA and ANA. The EUROPattern system incorporates automated positive/negative identification of ANCA, as well as pattern recognition for pANCA, cANCA and atypical ANCA (DNA-ANCA, xANCA). The latter can arise from antibodies against lactoferrin or other antigens. An estimated titer with a confidence value is given.

The computer-aided evaluation of ANCA with EUROPattern was compared to manual evaluation using 170 sera incubated on a BIOCHIP mosaic of ethanol-fixed granulocytes and formalin-fixed granulocytes. The overall agreement of results amounted to 98.2%. For the pattern assignment there was an agreement of 96.5% for cANCA, 94.7% for pANCA and 91.8% for atypical ANCA.

Further autoantibodies

The determination of autoantibodies on tissue substrates facilitates diagnosis of a range of autoimmune diseases. For example, investigation of autoantibodies in autoimmune liver diseases using the substrates rat liver and rat kidney supports the diagnosis and differentiation of autoimmune hepatitis type 1 and 2 and primary biliary cholangitis. Immunofluorescence signals on these two substrates can be evaluated automatically with the EUROPattern system. The evaluation includes positive-negative classification for relevant ANA (rat liver) and AMA (rat kidney), as well identification of an anti-liver kidney microsome (LKM) pattern using both substrates for reciprocal confirmation. The agreement between automated and visual evaluation on the tissue substrates amounted to 96.5% for ANA and 98.6% for LKM on rat liver and 94.6% for AMA and 98.9% for LKM on rat kidney.

Automated image acquisition for further tissue substrates, such as monkey liver, monkey stomach and monkey oesophagus, as well as for cell-based assays is also available.

Live and automatic microscopy

On-screen microscopy simplifies the IIF evaluation immensely by allowing recording and viewing of IIF images directly at the computer screen, thus eliminating the need for a dark chamber. The new EUROPattern Microscope Live (Figure 1) combined with EUROLabOffice 4.0 software (Figure 2), in particular, provides state-of-the-art live microscopy and fully automated acquisition of fluorescence images. The novel automatic laser focussing enables fast image acquisition and classification within two seconds per image. The images are recorded by means of a high-resolution camera, generating high-definition pictures. The microscope includes a self-calibrating long-life fluorescence LED which provides constant illumination, ensuring standardised quality between microscopes even at different locations. For live microscopy the multi-touch screen of the monitor allows easy navigation and zooming. Team consultations can be undertaken without the need for a discussion bridge.

Figure 1: EUROPattern Microscope Live

The EUROLabOffice 4.0 software classifies the fluorescence patterns and designates titers as described above. It communicates continuously between the LIS, the automatic processor and the microscope, ensuring rapid, secure, and traceable data exchange. Its complete network integration means that IIF results can be consolidated with findings from other analysis methods such as ELISA, immunoblot or ChLIA to produce a detailed and substantiated patient report. All information is presented clearly in the results window. Findings from different serum dilutions and substrates are consolidated into one report per patient, and new results are compared with the patient’s history. Negative samples can be confirmed in batches for added efficiency. All data, results and images are archived without the need for paper records.

Figure 2: Example of ANA evaluation with EUROPattern 

Perspectives

Computer-aided evaluation provides standardisation and consolidation of IIF results in autoimmune diagnostics. Automation platforms with harmonised software and hardware reduce workload for laboratory technicians and provide a more objective evaluation. The progression from hands-on microscopy to complete on-screen evaluation has resulted in an unprecedented level of convenience and efficiency in IIF diagnostics. Moreover, software incorporating deep learning processes provides accurate positive/negative classification, pattern recognition and titer designation at a quality equivalent to or better than visual microscopy. Further applications with pattern evaluation using neural networks will soon be added to the repertoire. 

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Arab Health and Medlab Middle East, the leading exhibitions for the healthcare and laboratory industries in the MENA region, generated AED767.7 million of new business deals during the live, in-person element of the show last month.

During the four-day showcase, inaugurated by H.H. Sheikh Ahmed bin Saeed Al Maktoum, Chairman of Dubai Civil Aviation Authority and Chairman and Chief Executive of Emirates Airline and Group, the exhibitions welcomed 22,800 visitors from 172 countries who connected with 1,700 exhibitors. A total of 61 countries were represented by exhibitors, which included 30 international pavilions.  

Related: Omnia Health Magazine June – July 2021

Wouter Molman, Executive Vice President for Informa Markets, said: “Arab Health and Medlab Middle East have been a resounding success this year and underscored the importance, and perhaps, more importantly, the demand, to host live and in-person events once again. Our overarching goal was to create a platform that was conducive to facilitating business deals by providing an opportunity to make connections, network and ultimately to support global healthcare recovery.”

Deals completed during the event included a collaboration between American Hospital Dubai and Etisalat Digital to enhance the patient experience by utilising multiple digital technologies. The Ministry of Health and Prevention, the EHSE, the DHA and DoH also signed a bulk purchase agreement for medicines and medical supplies.

Related: Arab Health Daily Dose 2021

Al Jalila Children’s Specialty Hospital (AJCSH) announced a high-profile agreement with Illumina Netherlands BV, the world’s leader in next-generation sequencing, to provide technical expertise, reagents and analysis tools and training to the group.

Elsewhere on the show floor, Gulf Medical University signed an MOU with GEOTAR-Med LLC, a leading company in Russia providing complex turnkey solutions for medical education, to develop, produce and advance exciting simulation equipment for education in healthcare professions.

At Medlab Middle East, a series of deals were completed, including G42 Healthcare who announced a partnership with Seegene, a global biotechnology company specialising in molecular diagnostics, to offer fully equipped mobile diagnostics and testing laboratories across the Mena region. Further announcements included Unilabs new diagnostic solutions deal with Roche Diagnostics.

Vincenzo Ventricelli, CEO, Philips Middle East, Turkey & Africa, said: “We’ve been very pleased with the positive feedback we’ve received during the show. Not only have customers been willing to come to the event, but they are also happy to engage, discuss, and make decisions in a face-to-face environment. This means business is being done faster and better.”

As part of the online element of the show, 19,699 visitors attended from countries including Chile, Congo, Mauritius, Zambia, Bolivia, Costa Rica & Dominican Republic, totaling over 31 countries who were only represented online thanks to the virtual aspect of the exhibitions. A survey of online participants revealed that 47% of online attendees had never attended either show in the past.

“These results underscore the importance of our online event by providing an opportunity for an even greater audience to participate. While the physical events remain a strong and impactful platform, which resulted in millions of dirhams worth of business generated at the in-person shows, the online element has so far facilitated over 46,300 unique connections from around the world," added Molman.   

The events, which took place under the theme of 'United by business, driving the industry forward’, was supported by the Ministry of Health and Prevention (MoHAP), Dubai Healthcare City Authority, Dubai Health Authority, and the Dubai Government.

As part of Informa Markets commitment to provide the highest hygiene levels at all events by ensuring attendees and staff safety, the event took place with protocols introduced via the company’s Informa AllSecure health and safety mandate. The enhanced measures include 35 guidelines covering all aspects of cleaning and hygiene, social distancing measures, and the use of PPE, screening, and a track and trace in conjunction with local authorities.

The 2022 edition of the show, which returns as a co-located event for the healthcare and laboratory industries, will take place from 24 – 27 January at the Dubai World Trade Centre.

“As an organiser, the learnings from hosting a live, in-person event concurrently with the online edition have been invaluable. The results have exceeded our expectations. As with our show theme this year, now is the time to drive the industry forward and prepare for 2022, where we look forward to replicating this year’s successes," concluded Molman.

For more information, visit www.arabhealthonline.com or medlabme.com

Blood transfusion is an important part of health services and is lifesaving in many conditions. SARS-CoV-2 (also known as COVID-19) has been an unprecedented challenge in many parts of the medical field with blood banking being no exception.

Blood services must be prepared to move quickly in response to changes in the pandemic situation. A national approach, rather than a sub-national or local approach, should be adopted for coherence and coordination, but taking into account any specific localised factors or needs.

Related: Spotlight on improving quality in haematology

The World Health Organization (WHO) has issued early during the pandemic a guidance for blood services entitled  “Maintaining a safe and adequate blood supply and collecting Convalescent plasma in the context of COVID-19 pandemic” to give directions and support to blood services in taking required action considering: mitigating the risk of staff and donor exposure to SARS-CoV-2 , managing the demand for blood and blood products , preventing disruption in supplies of critical material, temporary deferral of donors, mitigating the impact of reduced availability of blood donors, and equipment. The guidance was so important and useful to blood services.

During the pandemic, blood donation centres adopted additional eligibility criteria to ensure safety of blood donors and patients receiving blood. Such criteria have been continuously updated according to the information received from the WHO, Food & Drug Administration (FDA) and local health authorities in different countries.

Related: COVID 19 considerations in haematology

The WHO has provided no recommendations about screening the donors for SARS-CoV-2 by RT-PCR or immunoassays, however, it recommends temporary deferral for 28 days if any symptoms (cough, fever, flu) are present, or if they are exposed to a confirmed COVID-19 patient or have travelled to an epidemic area. It also recommends that the potential donors inform the blood donation centre if they develop symptoms within 28 days of donation. On March 2020, the American Association of Blood Banks (AABB) issued a toolkit and further recommending on eligibility criteria and deferral guidelines. The International Society of Blood Transfusion (ISBT) has afforded a wide range of scientific material to guide blood services during this critical time, through availability of guidance, educational sessions and live webinars through its website available for blood transfusion professionals.

The emergency and disaster authorities in almost all countries had implemented many guidelines to limit the spread of the infection and to ensure the safety of the population. The blood services faced a big challenge in maintaining its services that starts by availability of eligible blood donors. In most countries there was movement restriction for certain period of time, lockdowns and closures of many offices that was replaced by working from home. All of the previously mentioned factors have affected the organisation of blood donation campaigns and drives which is in most blood services the major source for blood donors.

The availability of a comprehensive and well-structured business continuity plan is an important part of any important facility planning to act during such a pandemic. To ensure donors safety during donation and staff safety in keeping social distance, blood services have adopted many measures such as giving appointments for donors to avoid crowds, extending or changing working hours, and in case their existing space for collection was small then finding temporarily bigger halls to carry out blood collection. Placing thermal cameras to check employee and donors body temperature at entry point to blood centre, frequent cleaning, social distancing in seating the donors and, of course, the usage of personal protective equipment as required by local health authorities. Ensuring the availability of the required number of donors was a big challenge that has been well managed in blood centres that have an updated data base for blood donors, including their contact telephone or emails. Contacting the donors by telephones, SMS, emails or calling public through social media posts has played a very important role in keeping the flow of blood donors to visit the blood centres.

Different countries have implemented different precautionary measures to avoid the transmission of COVID-19 among their populations. In many countries, lockdown strategies and social distancing is mandatory to reduce person-to-person transmission. Accordingly, the prevalence of asymptomatic cases has varied in different countries, and this has been reflected in blood donors.

Educating donors

In the absence of evidence-based guidelines, the international community has adopted conservative measures to ensure the safety of blood products at the level of blood donation. The recommendations suggest the education of donors on self-deferring in exposed or symptomatic patients and informing the blood centre if they develop COVID-19-related symptoms within 28 days of donation. Patients who had or were exposed to COVID-19 had to self-defer for at least 28 days. It was also recommended to quarantine the blood products until the donor is considered safe defined by the ‘absence of a reported subsequent illness’ and recall the blood components if the donor became symptomatic or reported contact with a certified case within 14–28 days of donation.

The prescription of blood products has been impacted by the decision of the medical community to defer elective surgeries and requested treating physicians to prioritise their blood and components requests. Priority was given to thalassaemic patients, oncology and critically ill patients. A good network between blood donation centres and ordering physicians is also very important.

The lessons learned from COVID -19 pandemic includes but not limited to the following:

1. The need to continuously be updated with the changes of the pandemic situation locally and at international levels by appropriate information from local health authorities and WHO.
2. Having an updated data base for registered blood donors to contact them during emergencies.
3. Social media’s role is an essential and important tool to educate the public about the need for blood donation, measures taken by blood facilities to ensure their safety during donation and working hours.
4. Having a well-structured business continuity plan, emergency and disaster plan and appropriate patient blood management policies and procedures.
5. Participation in conferences, workshops, working parties at national, regional and international levels has helped blood services a lot to learn from each other by sharing knowledge and experience.

Dr. May Raouf

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Focusing on the latest updates, diagnostic tools and disorders, the Haematology conference, taking place on June 21, at Medlab Middle East, will cover several developments in the field. In an interview with Omnia Health Magazine, Dr Aaron Han, Consultant pathologist and Infection Control physician, Kings College Hospital Dubai; Deputy International Commissioner for College of American Pathologists (CAP), and the Chair of the conference, highlighted several key topics that will be discussed during the sessions.

He said: “Medlab Middle East has been my “must attend” meeting every year. I am so excited it will be a live event this year. That is a big testament to the Dubai government on keeping us all safe throughout this pandemic.” Excerpts:

Could you give us an overview of your participation at Medlab Middle East? What will you be discussing?

Related: COVID 19 considerations in haematology

This year I will be chairing, and also speaking at the Haematology track on behalf of CAP on improving quality in the haematology lab. I am also a speaker at the histopathology track on the promise of artificial intelligence.

What has been the impact of COVID-19 on haematology and blood safety?

We have learned a lot about the importance of haematologic parameters in helping triage COVID-19 patients and matching the proper level of care to clinical severity. Dr Laila Al Suwaidi of Mohammed Bin Rashid University of Medicine and Health Sciences (MBRU) will be discussing one of Dubai’s big data projects on haematology and predictive ability in COVID-19. We have also seen rare incidents of haematologic illnesses which will be presented at this year’s conference by Dr Kayane Mheidly of Clemenceau Medical Center

What are the quality considerations to keep in mind when it comes to haematology?

Related: Improving Efficiency in the Haematology Laboratory

All of the labs in the UAE and most of the labs in the region are accredited. I am biased and believe that CAP provides the gold standard when it comes to the lab-quality framework. Participation in external quality assurance, having quality indicators that cover all the phases of lab testing is the starting point for lab quality. Also, having a critical mass of regional pathology leaders who care about quality makes this journey easier as we share best practices.

Dr Aaron Han

Is technology having an impact on improving patient outcomes?

Big data projects, point of care devices, artificial intelligence and smart algorithms all have the potential to improve outcomes. We are also seeing increasing adoption of telemedicine and telehealth which will continue to reshape our current practice. I believe that chronic illness management will be improved as a result of these innovations. Personalised medicine and genomics will continue to be adopted at a rapid rate. We have already seen the benefits of genetics and molecular medicine in helping us address the pandemic.

The theme of Medlab Middle East this year is ‘Reshaping the future of diagnostics.’ What does the future of haematology look like in your opinion?

In haematology, some of the exciting initiatives will be in applications of flow cytometry. Dr Rania Seliem, Chief at Rashid Hospital will update us on haematopathology diagnostics. Minimal residual disease detection and bone marrow transplantation will be exciting developments in the next couple of years for the UAE.

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.