The biotech market was estimated to be worth $1.55 trillion globally in 2023, and is due to grow at a compound annual rate of 13.96% between now and 2030[1]. Yet not all markets are equal; conditions are dynamic too. To delve deeper into biotech companies’ geographic strategy, and assess their changing perceptions against the experienced reality, Arriello recently commissioned a transatlantic survey among 200+ Regulatory, Safety and Quality Directors at small/medium biotechs, split 50/50 between the EU (Ireland) and North America (the US).

The companies polled already had a strong and well-balanced international presence, typically a blend of direct representation and indirect, via local partners. Direct representation is currently highest proportionally in Switzerland, followed by Norway and Austria, and lowest in Turkey, Mexico, Argentina, the Middle East, Japan, New Zealand, and France, where in-country partnerships are more common. In the US, where overall representation is highest (97% penetration), activity is split roughly 50/50 between direct and indirect. A similar ratio is reflected in the UK, where 87% of respondents cited an active presence.

Target markets

Looking at companies’ next priorities either for first-time entry or for active expansion, the survey revealed a consistent focus on the US, UK, and Canada in both categories – the US leading both as an immediate priority and of high interest in the near future.

The picture becomes more interesting when contrasting respondents’ current priorities versus their relative focus five years earlier (in 2019). Brexit has elevated the perceived importance of entering or expanding into the UK, so that it is at least as important a market as Canada now (where five years ago, Canada was a greater priority).

Brazil is now deemed an immediate priority, meanwhile, along with the Middle East which is also a strong interest for the near future. Five years ago, Brazil was sixth down the list (two places below Mexico, which no longer features as a priority target), while the Middle East did not feature as a top-10 market of interest.

The biotechnology market in Brazil is expected to reach revenues of over $69,140 million by 2030, if it achieves its forecast compound annual growth rate of 14.2% between now and then[2]. The country today accounts for the largest share of Latin America’s biotech market, which Grand View Research attributes partly to Brazil’s improving infrastructure and domestic biotech innovation.

The Middle East, which country by country is looking to reduce its dependence on oil as set out in a series of high-profile new economic national ‘visions’, has become a region of growing interest for life sciences, too. Saudi Arabia, for instance, is proposing possible market entry within as short a period as six weeks, as long as companies have the supporting infrastructure in place.

Barriers and green flags: perceptions versus reality

There is a general perception that it is still relatively complex and onerous to enter a new market, whatever efforts are in place to simplify processes. Respondents specified competition structure; political; and then legislative factors as the top three conditions for smoothing the way. By contrast, respondents ranked tax factors; resources/logistics; and cultural factors as contributing to a challenging experience.

When trying to enter new markets, respondents cited the following issues, in order of experienced negative impact:

1. The scale/degree of quality-related challenges (e.g. required licences/authorisations; associated roles such as Qualified/Responsible Persons; and Quality Management System requirements)
2. Pharmacovigilance-related infrastructure and expectations
3. Significantly lengthier timescales to approval
4. Substantially greater costs of market entry
5. Failure to understand the specific requirements of the new market.

Asked which markets had presented substantial additional access issues, respondents most commonly cited China, followed by Brazil. US-based companies were more likely to be affected by higher-than-anticipated costs when new market access plans went awry. Over a third of companies (36%) withdrew from the opportunity altogether, not going on to enter the market.

Learning the hard way

Where companies had encountered difficult market access experiences, respondents put this down to a range of contributing factors. Key lessons learned included:

• That Regulatory and/or Quality experts need to be involved much earlier and more intrinsically in initial decision-making and planning around target markets
• That Pharmacovigilance experts need to be involved much earlier and more intrinsically in initial decision-making and planning around target markets
• That other markets should have been considered instead
• That the European opportunity has changed, in terms of which countries are optimal to target
• That market size alone does not determine revenue or profit success.

Measures of success in the biotech market

Finally, the survey identified an evolution in the measures of perceived success in biotech over the last five years. Reflecting on the gauges applied in 2019, respondents deemed these to have been revenue performance; followed by the number of patients reached – then profitability. Today, by contrast, divestment or investor payback are the main considerations.

The role of problem-free compliance has risen too. Getting products successfully past regulators is clearly a critical step in achieving a good return for the business and its stakeholders. Compliance performance is particularly pronounced as a measure of success for respondents in the US: 43% of survey respondents here cited this as a main measure of success today.

With pressures likely to worsen before there is significant progress towards global harmonisation of requirements (almost 40% of survey respondents expected accelerated routes to market to increase the pressure), ambitious biotechs will need to allow more time and apply more scrutiny as they fine-tune their global expansion plans.

About the research

Conducted independently by Censuswide in September 2024, the quantitative research polled 210 senior managers or directors in regulatory/safety/pharmacovigilance/quality roles at small/medium biotech companies in the US and Ireland (101 and 109 respondents respectively). The full report can be accessed here .

About the author

Sam Tomlinson is Vice President of Global Drug Safety at Arriello.

References

[1] Biotechnology Market Size, Share & Growth Report, 2030, Grand View Research: https://www.grandviewresearch.com/industry-analysis/biotechnology-market

[2] Brazil Biotechnology Market Size & Outlook, 2023-2030, Grand View Research: https://www.grandviewresearch.com/horizon/outlook/biotechnology-market/brazil

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The assay from global health technology provider Mindray allows clinical teams to measure cardiac troponin I proteins that are released into the blood during heart attacks, and when the heart is damaged.

Found to be highly precise and sensitive for both men and women, the cardiac troponin I assay has been the focus of a new study carried out by world-renowned cardiac biomarker specialists at Hennepin Healthcare’s Hennepin County Medical Center in Minneapolis, Minnesota. Early evidence has shown significant potential for clinical applications in helping to reduce pressure on busy emergency departments.

Opportunity for Clinical Diagnosis of Heart Attack Risk

Researchers found that the test not only performed as well, if not better, than those already available in the market, but that it also had the potential to help clinical teams rule out many patients with symptoms suggestive of a heart attack at an early stage.

Focussing on more than 1,500 patients who presented to the inner-city hospital’s emergency department with symptoms such as chest pain, arm pain, or jaw pain, the study found that 15% of early presenters could be ruled out for a heart attack based on a single blood test on arrival at hospital.

Typically for most assays of this kind, an initial blood examination would serve as a baseline measurement for early presenters, with a further test required to detect cardiac troponin I two hours later.

Combining this approach and applying a second blood sample to the Mindray assay after two hours, researchers also found that an additional 30-40% of remaining participants could also be safely ruled out with less than a 1% probability of an adverse event within 30 days.

Unusually precise measurements of cardiac troponin I made possible using the Mindray assay, meant additional individuals could also be ruled out. In total, across all cardiac troponin I measures, researchers were able to identify 60% of patients presenting to the emergency department with heart attack like symptoms, who could be safely sent home.

Opportunities for Cardiac Troponin Assay

Professor Fred Apple, the study’s principal investigator, a medical director in laboratory medicine at Hennepin Healthcare, professor at the University of Minnesota, and a former committee chair of the International Federation of Clinical Chemistry and Laboratory Medicine Committee on Clinical Application of Cardiac Bio-markers, said: “Patients who comes in to an emergency department with chest pain or arm pain, symptoms suggestive of a heart attack, would rather spend the night at their home with a surety that they aren’t going to have a heart attack, versus a bed in the hospital. But sometimes it can be difficult for a clinician to determine whether or not that pain is related to the heart.

“Our preliminary findings around Mindray’s high-sensitivity troponin I test are exciting for emergency medicine – with multiple ways this could be built into algorithmic clinical practice to help avoid overcrowding and enhance triage safety.

“Cardiac troponin alone doesn’t determine if you have had a heart attack, but it can tell the clinician if the heart has been injured, and when measurements are normal that it is safe to send a patient home.

“In 40 years of cardiac biomarker research, this assay is as good, if not better than any cardiac troponin assay I’ve worked with in my career. That it is so incredibly precise and analytically very sensitive to measure low cardiac troponin concentrations, opens new and unique possibilities when patients present early to an emergency department, so that clinicians can make informed decisions to send people home, without concern.”

In addition to ruling individuals out, findings also demonstrate that the assay can help to determine with high probability when patients are having a heart attack, with a high positive predictive value of approximately 70%. Researchers believe this could assist clinical decisions to immediately admit patients.

The Institutional Review Board approved study (MERITnI) was conducted alongside existing tests as patients presented to the hospital. Standard hospital procedures were used in the triage and care of patients, and the same blood samples drawn for routine clinical practice were also applied to the Mindray high sensitivity cardiac troponin I assay for research purposes, in order to evaluate the assay. The Mindray assay used in research was not used for patient care decisions during the study.

The assays were produced by Mindray after it acquired the Finnish company HyTest in 2021, where Professor Apple previously served on the board.

Preliminary findings are now undergoing peer review, but already additional possibilities are being explored. Future work in examining high sensitivity cardiac troponin I and high sensitivity cardiac troponin T assays are expected to inform applications that might help clinicians to better understand if myocardial injuries are chronic or acute – and help them to determine the best treatments and therapies for patients.

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Cyberattacks Correlate with Increased Patient Mortality

A recent study of more than 600 IT professionals working at over 100 medical facilities revealed a link between health care cyberattacks and increased mortality rates. A large percentage of respondents reported cybersecurity incidents often worsened patient outcomes.

The possible connection between health care cyberattacks and patient mortality has been an ongoing discussion for years. Although previous studies on the subject exist, their scope was much narrower. This new research finally proves they correlate.

This 2023 study reveals the four most common health care cyberattack types — business email compromise (BEC), supply chain attack, ransomware and cloud compromise — increase delays, average visit length, procedure complications and patient mortality rates.

Of the 88% of health care organizations that experienced cyberattacks in 2023, roughly 20%-30% reported more fatalities as a result. IT professionals stated mortality rates increased by 28% for ransomware, 12% for BECs, 21% for supply chain attacks and 29% for cloud compromises. These substantial increases highlight the gaps in their cybersecurity.

How Cyberattacks Increase Patient Mortality

Truthfully, few patients have died as a direct result of a cyberattack. However, this new study proves the two variables correlate. This is because downed systems, inaccessible patient data and service disruptions incidentally harm people. Diminished quality of care almost always leads to poor outcomes.

Cyberattacks directly cause 57% of health care facilities to experience worse patient outcomes. Delays, disruptions, unplanned transfers, and cancellations led to increased complications and poor quality of care. Wasted hours and inaccessible systems have a ripple effect, impacting every service, from laboratory testing to medication dispensing.

Although fatalities caused by health care cyberattacks are uncommon, such cases have made national news before. In 2021, one mother sued a hospital after ransomware-related disruptions allegedly caused her baby to suffer brain damage during delivery and later pass away. These situations have significant financial, legal and security implications.

Every Health Care Facility Needs Adequate Cybersecurity

The cybercriminals behind health care cyberattacks accept heightened patient deaths as collateral damage because it increases the odds of their success. After all, a hospital is far more likely to pay an outrageous ransom to regain system access when people’s lives are at stake.

Experts believe the growing Internet of Things (IoT) will simplify distributed denial-of-service attacks (DDoS) attacks. Some also predict a ransomware incident will occur every two seconds by 2031. As the severity of cyberattacks increases, health care IT professionals will have to contend with the fact their security measures are one of the few things protecting patients.

Undoubtedly, cyberattacks will grow more severe than they have been for years. For instance, DDoS attacks now last 50 hours on average, up from their mere 30-minute duration in 2021. If health care organizations plan on protecting patients, they must address these growing concerns.

Whether organizations increase cybersecurity funding or expand their endpoint protections, proactive effort is critical. After all, research proves these actions are just as crucial to patients’ well-being as safety equipment or emergency services. A facility’s digital security measures will be its best defence if a cyberattack occurs.

Health Care Cybersecurity Is Now About Saving Lives

For too long, cybersecurity efforts have focused on indirect rather than direct patient outcomes. Instead of preventing critical system failure to safeguard people’s well-being, IT teams have prioritized securing data and privacy. While information security is essential, the new research linking cyberattacks to heightened mortality rates demands action.

Although compliance with regulations like the Health Insurance Portability and Accountability Act is critical, neglecting this newfound link will only lead to higher mortality rates as the frequency of cyberattacks increases. Health care cybersecurity is no longer just about patient privacy and data security — it’s now about saving people’s lives.

Even when a cybersecurity incident doesn’t result in death, it still risks patients’ well-being. Consider the situation where a nurse gave a 3-year-old boy five times the amount of medicine she was supposed to because ransomware prevented the computer from calculating the dosage for her.

Patient Health Depends on Proper Health Care Cybersecurity

Health care facilities must address the most common industry risks. While the recent study named supply chain attacks, BEC ransomware and cloud compromises as the most significant dangers, human error is often the source of most cybersecurity incidents. In fact, 30% of chief information security officers ranked insider threats as the top threat of 2023.

Adequate cybersecurity training, privilege limitation and digital monitoring are essential for reducing insider threats. Even though the IT team can’t account for every possible mistake a person can make, they can segment networks and make data backups to minimize the negative impact human error can have.

Safeguarding critical systems, having backups available and preparing an adequate incident response is crucial. While health care facilities already undertake a significant workload to maintain compliance and protect privacy, they must understand how critical cybersecurity is for patients’ safety.

Organizations Must Prioritize Cybersecurity

Previously, health care organizations have viewed cybersecurity as essential because it protects patient privacy and safeguards sensitive data against leaks and breaches. However, it’s now about saving people’s lives — it has become absolutely critical.

Much like a medical professional needs safety equipment to perform surgery, health care facilities need security measures to protect patients properly. Since the link between cyberattacks and mortality rates is proven, prioritizing cybersecurity is in the industry’s best interest.

By Zac Amos, rehack.com

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Their voices have been elevated in this first global, multiphase research report to not only understand where the healthcare system is following the COVID-19 pandemic, but where it needs to be in 10 years to ensure a future that both providers and patients deserve.

“Doctors and nurses play a vital role in the health and well-being of our society. Ensuring they are being heard will enable them to get the support they need to deliver better patient care in these difficult times,” said Jan Herzhoff, President of Elsevier Health. “We must start to shift the conversation away from discussing today’s healthcare problems to delivering solutions that will help improve patient outcomes. In our research, they have been clear about the areas they need support; we must act now to protect, equip and inspire the clinician of the future.”

There has never been a greater need for lifting the voices of healthcare professionals. The global study found 71% of doctors and 68% of nurses believe their jobs have changed considerably in the past 10 years, with many saying their jobs have gotten worse. One in three clinicians are considering leaving their current role by 2024, with as many as half of this group in some countries leaving healthcare entirely. This comes on top of the existing global healthcare workforce shortage, where clinicians continue to experience severe levels of fatigue and burnout since COVID-19 was declared a pandemic.

“As a practicing doctor, I am acutely aware of the struggles today’s clinicians face in their efforts to care for patients,” said Charles Alessi, MD, Chief Clinical Officer, Healthcare Information and Management Systems Society (HIMSS). “This comprehensive report from Elsevier Health provides an opportunity for the industry to listen — and act — on the pivotal guidance given by those on the frontlines. I commend this important initiative and look forward to next steps in supporting our doctors and nurses.”

What today’s clinicians want for the clinician of the future

The “Clinician of the Future” report includes a quantitative global survey, qualitative interviews and roundtable discussions with nearly 3,000 practicing doctors and nurses around the world. The data helps shed light on the challenges impacting the profession today and predictions on what healthcare will look like in the next decade, according to those providing critical patient care. To ensure a positive shift moving into the future—and to fill current gaps—clinicians highlight the following priority areas for greater support.

Enhancing health technology skills: Clinicians predict that over the next 10 years “technology literacy” will become their most valuable capability, ranking higher than “clinical knowledge.” In fact, 56% of clinicians predict they will base most of their clinical decisions using tools that utilize artificial intelligence. However, 69% report being overwhelmed with the current volume of data and 69% predict the widespread use of digital health technologies to become an even more challenging burden in the future. As a result, 83% believe training needs to be overhauled so they can keep pace with technological advancements.

A greater focus on the patient-provider relationship: Clinicians predict a blended approach to healthcare with 63% saying most consultations between clinicians and patients will be remote and 49% saying most healthcare will be provided in a patient’s home instead of in a healthcare setting. While clinicians may save time and see more patients thanks to telehealth, more than half of clinicians believe telehealth will negatively impact their ability to demonstrate empathy with patients they no longer see in person. As a result, clinicians are calling for guidance on when to use telehealth and how to transfer soft skills like empathy to the computer screen.

An expanded healthcare workforce: Clinicians are concerned about a global healthcare workforce shortage, with 74% predicting there will be a shortage of nurses and 68% predicting a shortage of doctors in 10 years’ time. This may be why a majority of global clinicians agree that a top priority will be to increase the number of healthcare workers in the coming decade. Clinicians require the support of larger, better equipped teams and expanded multidisciplinary healthcare teams, such as data analysts, data security experts and scientists, as well as clinicians themselves.

“While we know that many nurses are leaving the profession due to burnout, we also know that the pandemic has inspired others to enter the field because of a strong desire for purposeful work,” said Marion Broome, PhD RN, FAAN, Ruby F. Wilson Professor of Nursing at the School of Nursing, Duke University. “We must embrace this next wave of healthcare professionals and ensure we set them up for success. Our future as a society depends on it.”

Looking to the future

Findings from this research will be leveraged to provide strategic insights and solutions for physicians, nurses, educators, healthcare administrators and policymakers as Elsevier Health establishes initiatives designed to address the gaps highlighted; provide an annual Elsevier Health “Clinician of the Future” pulse survey to ensure these voices continue to be front-and-center; convene a Global Coalition of healthcare leaders and institutions to explore solutions at the medical school and clinical practice level; and explore the issue of patient empathy in partnership with our trusted research journals and subject matter experts.

“Ultimately, we asked clinicians for what they need, and now it’s our responsibility as a healthcare industry to act,” said Thomas (Tate) Erlinger, MD, MPH, Vice President, Clinical Analytics, Elsevier Health. “Now is the time for bold thinking — to serve providers and patients today and tomorrow. We need to find ways to give clinicians the enhanced skills and resources they need to better support and care for patients in the future. And we need to fill in gaps today, to stop the drain on healthcare workers to ensure a strong system in the next decade and beyond.”

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The research, undertaken by Healthcare Communications, revealed that 89% of NHS Trusts had delivered new digital appointment services as a direct response to the Covid-19 pandemic and the remaining 11% already had digital appointment services in place and further expanded their use. A YouGov survey of GB adults (18+) showed that 48% have a preference for digital communications for healthcare providers, which increases to 69% if you include telephone communications.

The figures were released in a white paper that analysed the trajectory of digital transformation across the NHS in England and looked at how it had affected patient experience. It also revealed the impact of restricted visiting arrangements and the role that digital technology can have in supporting patients and their loved ones.

Kenny Bloxham, Managing Director of Healthcare Communications, said: “Our original data and interviews reveal the extent of transformation across the NHS and demonstrate the innovation that is occurring up and down the country. One element that really came to the fore was the need to not make assumptions regarding how patients would like to receive their care. Patient choice is absolutely crucial and we would urge trusts to make full use of feedback technology available to monitor and deliver according to these preferences.”

Mark McKenna, Head of Patient and Family Experience, Liverpool University Hospitals NHS Foundation Trust, was interviewed for the whitepaper. He admits to being surprised by some of the patient feedback his trust received during the pandemic. “It’s easy to have sweeping generalisations about older age groups and technology – such as that they wouldn’t be able to use digital solutions and that they may not have the equipment they need. We found this was not always the case.”

Meanwhile, Amanda Hynes, Family and Friends Test Manager at Leeds Teaching Hospitals NHS Trust, explained: “This is the prime time to understand what our patients are experiencing. Feedback gives you some assurances, as staff members can sometimes be too close – it’s about seeing the care experience through the patient’s eyes.”

The whitepaper provides a series of recommendations for trusts to consider that are designed to optimise patient experience, which includes: the need provide choice around online or offline appointment methods; the need to monitor patient satisfaction levels over time; the benefits of sharing action taken as a result of patient feedback; and the benefits of sharing positive feedback with staff.

Commenting on the whitepaper findings, Digital Health Advisor Sam Shah said: “Digital health and modes of interacting with patients are evolving, depending on patient need they are increasingly likely to have a blended experience of online and offline healthcare. This raises the need to consider their experiences even more carefully and use a range of opportunities to obtain feedback and insights about their experiences. There is also a responsibility on all healthcare providers to recognise the heterogenous nature of the populations that we treat in terms of their digital literacy, their digital access and the digital penetration in the areas in which they live or work. Progressive trusts have built on existing feedback mechanisms such as FFT, and augmented these with more nuanced forms of obtaining insights about experiences. The evidence in this report highlights that a multi channel approach to feedback is just as important as the multichannel delivery of healthcare.”

Read the whitepaper, “Digital Transformation and the Patient Experience”, to find out more.

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Some of the major drivers for the expansion of the global IoT medical devices market include rising need for cost effective solutions in medical and healthcare sectors, increase in the incidence of chronic health conditions such as cancer, cardiovascular diseases, arthritis, and diabetes, and the rising burden it creates on the healthcare facilities and infrastructure. Furthermore, rising number of new medical centers and hospital set-ups in various parts of the world are also creating new opportunities in the global IoT medical devices market.

Increasing Focus on Patient Safety Fuels Demand in IoT Medical Devices Market

Patient engagement and patient care are contemporarily given more importance in the field of healthcare. This has also boosting the growth in the global IoT medical devices market. Moreover, rising number of patients and their family members are opting for products in order to gain proper and efficient hospital care. Increasing focus on the safety of patients is anticipated to create new avenues for expansion of the global IoT medical devices market in coming years.

Rising usage of new networking technologies as well as inception of high speed internet services has propelled the demand for healthcare IoT products and services. Furthermore, increasing usage of smart mobile computing devices such as smartphones and tablets is also expected to encourage the usage of products in the market in coming years, Although the high cost of deployment associated with connected medical devices and equipment may pose as a restraint for the healthcare market in current times, it is anticipated to draw more revenue into the industry in the long run.

Major regions functional within the global IoT medical devices market include Middle East and Africa, Latin America, Europe, North America, and Asia Pacific. Geographically, Asia Pacific region is projected to exhibit stunning growth rate in coming years owing to rising number of governmental initiatives promoting the usage of eHealth solutions, increasing medical tourism in the region, rising demand for quality healthcare facilities and services, and rising awareness among regional population about IoT products.

Players in the IoT Healthcare Market

Some of the major incumbent players operational within the global IoT medical devices market include Welch Allyn, Hill-Rom, Koninklijke Philips N. V., Medtronic, Johnson & Johnson Services, Inc., Siemens AG, and Boston Scientific Corporation, among others. Players and stakeholders in the global IoT healthcare market are adopting various growth and expansion strategies including strategic partnerships, mergers and acquisitions, and product innovations to capture a dominant industry position. For example, Surgical Theater and Medtronic announced a partnership in 2021 which interfaces Medtronic’s surgical navigation system called ‘StealthStation S8’ with Surgical Theater’s augmented reality technology ‘SyncAR’.

EarlySense was acquired by Hill-Rom in 2021 in order to build a differentiated suite comprising of connected devices solutions to improve patient outcomes. Furthermore, Insulet and Abbott partnered up in 2020 to provide automated insulin delivery through glucose sensing.

Source: Transparency Market Research

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In the last decade there has been an increase in the number of seniors who use touchscreen devices and technology, as a way to help cover their social needs. However, in 2019, there were still 2.8 million people aged 75+, 1.1 million people aged 65-74; and 0.5 million people aged 55-64 in the UK who did not use the internet.

Only 9% of people aged 65-74 made video calls regularly in 2018, with only 7% of people older than 75 doing the same. Over 79% of all digital exclusion was among those aged 65 and over.

Two-fifths (39%) of people aged 50 plus in England say they are using the internet more since the coronavirus outbreak. However, usage has increased most among groups already using the internet regularly and so far, there is little evidence that the pandemic has led to significant numbers of those previously digitally excluded getting online.

The Problems with Touchscreens and the Elderly

It is often believed that the use of touchscreens is one way to reduce this barrier to entry. Touchscreens are considered as natural and easy to use, and therefore they are often used in products designed to assist the elderly. However, the particular way touchscreens work and are used; could mean that thousands of seniors still aren’t able to use them.

It is a common misconception that when a touchscreen doesn’t respond to your finger, it is because your finger isn’t warm enough. But in fact, touchscreens aren’t detecting the heat of your finger, but its ability to conduct electricity. Capacitive touchscreens (almost all screens used by the average user) generate a small electrical field and it is the disturbance in the electrical field, when your finger conducts the electricity from it, that is sensed by the screen.

Certain characteristics of the fingers can reduce the electrical conductivity of the skin, such as calluses or dry skin; as the thick skin of calluses impedes electricity flow, and dry skin lacks the moisture needed for the electricity to travel.

When we age we naturally lose moisture from our skin, as the skin loses some of its ‘lipid’ content – essentially fats in the skin – that are essential in forming a barrier to hold moisture in5. It has been found that we can lose as much as 65% of our skin lipid content over time6. Likewise, as we age, we lose sweat glands5 that can provide vital external moisture when interacting with touchscreens. Dry skin is associated with other skin conditions in the elderly that cause abnormal thickening of the skin.

This issue is common in the elderly: it has been found that, in multiple studies, that 60% of seniors have dry skin. One study even showed that 99.1% of care home residents develop dry skin. It is therefore not surprising that it has been observed in studies that elderly people with dry or wrinkled fingertips have significant difficulty with getting tablets to recognise their touch.

11.8 million people are 65 years or older, therefore, being conservative and applying the 60% statistic, this would suggest that 7.08 million people would have dry skin in the UK alone. One study

has reported that dry skin meant that touchscreens didn’t recognise the touch of 25% of the participants, with another study reporting the same with 28% of the participants. Therefore it is possible that up to 1.98 million people with dry skin find touchscreens difficult to use as a result.

According to the report commissioned by digital health company No Isolation it is not surprising that with these additional health concerns that the elderly experience, they have difficulty in engaging with technology independently.

Their research found that 1.98, 3.07, and 2.95 million people may have difficulties in using touchscreen technology due to dry skin, physical impairments and subjective cognitive decline (SCD) respectively. 30-40% of these people will have both physical impairments and SCD30; accounting for this, we believe that in total 5.6 million unique people over the age of 65 in the UK find touchscreens difficult to use due to health barriers.

Read the full report here.

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By using a continuous wave radar-based system to sense tiny chest movements, the new method can accurately measure an individual’s vital signs including heart rate and respiratory rate without the need for wires, probes, wearable technology or other skin attachments. It could also identify early signs of heart disease like Arrythmia while highlighting deterioration for those living with Dementia.

The new technique will benefit all ages as well as those with COVID-19 where the risk of cross-infection is high.

Dr Dimitris Anagnostou, Associate Professor and project lead, explains: “Continuous monitoring of an individual’s vital signs can be necessary for several reasons. In hospital, it helps clinicians to determine which patients need urgent help, if someone is improving and can provide early warning signs of a more significant problem allowing quicker intervention.

“For infants and young children, extended use of electrodes and probes can cause skin damage as well as additional distress. Burn patients and those with compromised skin conditions are more challenging to monitor for long periods with wired devices. Our technology allows a patient full mobility while being monitored 24/7. Capable of working unmanned, the signal can also penetrate walls and protects privacy.

“Our approach has wide reaching applications for the treatment of COVID-19 and can allow the progression of the virus to be monitored long-term without increasing the risk of infection.”

For many elderly people, monitoring is now necessary at home. Despite leaps forward in technology, such as wearable sensors embedded in watches, for individuals living with Dementia, remembering to put on a watch or wearing one continuously is problematic.

Dr Anagnostou continues: “While our radar technology is not designed to be a diagnostic tool, we are confident it can support those with assisted living needs to remain at home for longer with greater confidence that they have unintrusive, real-time, continuous health and vital signs monitoring. This technology clearly demonstrates what can be achieved through academic collaboration across disciplines and institutes.”

Radars have been widely used for many years to determine the distance between aircrafts or the velocity of a vehicle by comparing the frequency or phase shift of the reflected and transmitted signals.

The new research works by using radar to monitor vital signs through the detection of tiny physiological movements in the body of around 1mm even when an individual is asleep. The results of the research indicate excellent accuracy even if a relatively low frequency (2.4 GHz) is used, thanks to the novel system architecture and specialised components. It is believed this will aid its progression into home and clinical settings more quickly.

The team has designed a proof-of-concept prototype which can be built into a hospital headboard or mounted on the ceiling. Further applications could include its use in prisons, care homes and sheltered housing.

The team will now take the project a step further, utilising Wi-Fi signals to extract complimentary location and position tracking data that will further support those with assisted living needs to feel safer at home. The team will trial the technology which shows when a person has fallen or if their daily movements have significantly changed, highlighting the progression of several degenerative diseases.

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Rupan Bose, MD, MB, Rebecca M. Ebert, BS, Leslie A. Saxon, MD

INTRODUCTION

We now live in an on-demand era. The majority of Americans have access to almost any type of information right in their palms. It is estimated that not only do 96% of Americans own a cell phone, but approximately 81% own a smartphone (Pew Research Center, 2019). Additionally, these statistics are relatively consistent across demographics. The ubiquity of these devices, paired with an ever-growing app ecosystem, allow for on-demand access to almost any kind of personal information, including access to entertainment, finance, retail, and work data (Saxon, 2016).

This unprecedented access will change how we interact with services and workflows and recalibrate our expectations regarding data ownership. Previously, product and service offerings were at the mercy of predetermined schedules for end-consumers. Before Netflix, consumers resorted to television guides to determine when to watch a certain movie – now consumers stream at their convenience. Before Uber, consumers looked up public transportation schedules to design their trip – now consumers order rider on-demand. With this digital revolution, consumers are dictating when and how they access data instead of relying on traditional providers. However, one area that is missing from this on-demand transformation is access to personal health data and care.

However, over the last decade, the trend towards personal cardiac monitoring has changed this dynamic broadly and swiftly. Smartphone enabled Electrocardiogram (ECG) recorders have flipped the workflow of how patients self-monitor and identify concerning findings and then seek care (Bose & Saxon, 2019). These devices offer a novel way to capture cardiac metrics such as heart rate, heart rhythm, and intervals in a form factor that is seamless. Devices like the AliveCor Kardia mobile ECG device and the Apple Watch have emerged as prototypical examples of these convenient, medical-grade diagnostics that integrate with smartphones and provide long term monitoring outside the confines of brick-and-mortar clinics. Apple reportedly shipped over 30 million Apple Watches in 2019, meaning that on-demand ECG monitoring has now reached the literal hands of tens of millions of people globally (Naas, 2020).

We have seen numerous stories of patients identifying arrhythmias using these devices and then taking their recorded ECGs to a cardiologist, thus further reinforcing the value of such devices (Saxon, 2013). This contrasts previous care models where patients presented to clinic visits endorsing past symptoms that need to be investigated retroactively. As cardiovascular disease continues to be the leading cause of mortality globally, novel innovations in the diagnosis and management of such diseases using ubiquitous technologies are bound to permeate to the care models of other diseases (Mensah et al., 2019). However, in order to continue this evolution, we must continue learning what motivates patients and consumers to use these devices and incorporate these findings into future designs.

We looked back at the AliveCor Mobile Device ECG Usability Study (2013 – 2015) to better understand how people interacted with these types of devices. We wanted to understand the demographics, behaviors, levels of comfort with technology, and other characteristics of people who use such devices. We sought to better understand the implications that these devices have on patients’ ability to self-learn about their diseases and leverage those findings to design future cardiovascular care models and devices.

EARLY EXPERIENCES – THE ALIVECOR MOBILE DEVICE ECG USABILITY STUDY (2013 – 2015)

The AliveCor Mobile Device ECG Usability Study enrolled subjects into a six-month longitudinal study to understand the characteristics and behaviors of those using the commercially available smartphone enabled AliveCor Kardia ECG monitor.

Recruited subjects were consented virtually using the DocuSign platform (DocuSign, San Francisco, CA). At the time, each step was done individually. However, today, Apple’s ResearchKit platform has since emerged as a seamless way to obtain informed consent, deploy surveys, and monitor active tasks (Jardine et al., 2015).

AliveCor Kardia ECG devices were distributed to participants. Participants were taught how to capture 30-second single lead ECG rhythm strips using the device. The rhythm strips were automatically analyzed for normal sinus rhythm or an arrhythmia such as Atrial Fibrillation (AF) using AliveCor’s FDA-cleared AF algorithm (AliveCor Inc., 2014). The rhythm strips could then be uploaded to a cloud-based secure database, where they could be accessed by authorized physicians via a secure portal.

All users were sent periodic surveys throughout the six-month period. Users received a survey prior to receiving the device with questions pertaining to their background, occupation, and general behaviors around technology and medical devices. Users then received subsequent surveys at one month, three months, and six months. Survey questions pertained to device-use and behaviors. Surveys were completed virtually, and results were statistically analyzed.

Study Population

From October 2013 through December 2015, a total of 1,345 participants were enrolled into the study. Recruitment was aimed at both members of the medical community and from the general population. Of this initial group, a total of 1,166 completed the entry survey and submitted an ECG transmission. In this group, 58.1% were male, mean age was 38.2 ± 13.6 years, and 44.1% were medical professionals. The majority of participants had previously used a digital device for health monitoring (75.7%), believed it is “very important” to use digital devices to monitor health (88.2%), and stated that the use of a mobile ECG recorder would make them more conscious about their health (77.6%). Also, 71.6% reported having experienced palpitations before, and 74.3% reported never having heard of AliveCor prior to the study. Additionally, 54.2% of study participants reported ease-of-use as a strength of the device. Though this study’s average age of 38.2 appears young when compared to the expected age of patients with significant cardiovascular disease, it is comparable to the average age of the US population, which was 38.2 in 2018 (Rogers, 2019).

Use Data

A total of 28,449 ECGs were transmitted through the AliveCor Kardia mobile app during the study. On average, subjects submitted 59.7 ECG submissions over the six-month period. Nineteen subjects submitted greater than 300 transmissions. The number of ECG transmissions increased with age (Figure 1). Subjects aged 70-80 transmitted approximately 4x more ECGs per subject (158.8 transmissions/person) compared to subjects aged 30-40 (38.6 transmissions/person). Subjects working in the technology industry recorded the highest number of average ECG transmissions (78.5 transmissions/person), and subjects working in academics transmitted the fewest number (34 transmissions/person).

Figure 1. Average number of ECGs recorded per person over the 6-month study period by age group

By six-months, 68% of users had stopped using the device. This did not vary significantly by age, gender, or profession. Medical professionals were more likely to abandon the device earlier in the study (47% vs. 41% at one-month) and transmitted an ECG less frequently (every 12 days compared to every 7 days).

Amongst survey questions pertaining to context, the two most common settings in which ECGs were recorded were in social settings and with physical activity/exercise. This did not differ significantly between medical professionals and other subjects. Certain other settings appeared to be common reasons amongst users: 8.1% of transmissions were associated with caffeine intake, 3.9% associated with palpitations, 0.9% associated with dizziness, and 0.6% associated with chest pain. During the study, 77% of non-medical users endorsed using the device to investigate palpitations compared to 63% of medical users.

ECG Data

The average recorded heart rate (HR) was 74 beats per minute (bpm) (minimum 31 bpm, maximum 265 bpm). Bradycardia below 40 bpm was detected on 85 transmitted ECGs, and tachycardia faster than 150 bpm was detected in 255 transmissions. Mean HR declined with age as users aged 30-40 had a mean HR of 79 bpm whereas users aged 80-90 had a mean of 70 bpm (Figure 2). Male subjects had a lower average HR (70 bpm) compared to female subjects (73 bpm).

Figure 2. Mean heart rate seen in each age group

IMPLICATIONS OF HISTORICAL FINDINGS ON FUTURE DESIGNS

In this predominantly young, non-medical cohort, the findings demonstrate a tremendous appetite for on-demand ECG recordings. Subjects repeatedly used these devices to not only investigate medical symptoms, but more interestingly, used it in settings beyond the medical context such as in social settings and during physical activity. Health data has traditionally been in a silo; however, users demonstrated a collective interest in learning how their health interfaces within the greater social context.

Unsurprisingly, average ECG transmissions per person appeared to increase with age. One explanation may be that older users are more concerned about their health or may have a higher probability of symptoms that trigger a desire to record an ECG. Nonetheless, this demonstrates that older users have a significant ability to leverage technology to monitor their health. Though users in the 70-80 age group may not traditionally be viewed as technologically savvy, this study demonstrates that they are a prime audience for emerging healthcare technologies, and they deserve further studies to understand how to design experiences for them.

The results reinforced previously described “real-world” HR trends with age, as seen in previous large-scale studies. The study found an average HR of 79 bpm in subjects aged 30-40, which decreased to an average of 70 bpm in subjects aged 70-80. In the recently published data from the UCSF Health eHeart study (June 2019) with data from 66,788 subjects using smartphone photoplethysmography devices, their results found a similar average HR of 78.5 bpm in subjects aged 31-40, which decreased to an average of 73 bpm in subjects aged 71-80 (Avram et al., 2019). These results reinforce the consistency of such devices and reiterate their ability to capture meaningful data outside the clinic.

One of the challenges that came to light in this study is that 68% of users had stopped transmitting ECGs by six-months. Our interpretation of this is that despite an initial intrigue with the device and the ability to record ECGs, this novelty wears off. One possibility is that despite the device being easier to use than traditional 12 lead ECG recorders and Holter monitors, it does carry its own burdens (Barrett et al., 2014). At the time of this study, the AliveCor device was a standalone device separate from the smartphone. Perhaps carrying two devices became onerous. Another possibility is that capturing an ECG required the user to actively initiate a recording. Over time, as interest perhaps decreased, this barrier of actively initiating a recording perhaps outweighed the presumed benefit. Finally, another reason for progressively decreased usage may stem from the lack of a captivating user experience associated with recording ECGs. At the time of this study, the user experience was rather minimal – open the app, push the button to capture the recording, and then review it. In the future, a more engaging experience may be necessary to motivate users to continue recording.

The takeaways of this study are to leverage these findings to guide future designs of remote diagnostic devices. These findings indicate that devices should aim to streamline use, which can be achieved by: (1) building these ECG abilities directly into the devices that people already use daily, and (2) designing them to initiate ECG recordings in the background without requiring active initiation. We have seen steps in this direction with Apple launching the ECG feature directly on the Apple Watch, thus leveraging a device that is already a part of peoples’ daily lives. Apple has developed built-in algorithms to seamlessly detect bradycardia, tachycardia, and atrial fibrillation of these ECGs (Doshi et al., 2019). Finally, devices will need engaging experiences – which may come in the form of gamification or through improved education portals – to promote continued usage.

As these devices become more ubiquitous, these devices will change the way we manage cardiovascular disease outside the clinic. In today’s care paradigm, we as a medical community manage diseases based on episodic clinic visits, which can often occur with months or years in between. Devices like this will help clinicians obtain better insights into patients’ signs and symptoms outside the clinic, which can be leveraged to make meaningful clinical decisions and improve outcomes. These insights can also promote broadening the care model to a global, virtual care clinic where patients and physicians can make decisions together from any location (Shinbane & Saxon, 2016). It also allows for patients to learn about their clinical condition, for which, as this study shows, there is a growing interest.

ON-DEMAND REMOTE DIAGNOSTICS IN THE COVID-19 ERA AND BEYOND

At the time of writing this article, we are in the midst of the COVID-19 pandemic. The medical community is facing new challenges of how to care for patients safely, and patients are facing new challenges of how to navigate their chronic diseases. Many clinics are closed and are relying on telemedicine visits. We are realizing the challenges of traditional healthcare models that rely heavily on in-clinic practices. Additionally, patients are concerned about exposure if they enter a clinical setting. In the author’s experience, one patient had a history of intermittent palpitations, and was experiencing them during a telemedicine visit, but was hesitant to seek care. This patient is an ideal candidate to evaluate and triage using remote diagnostics. This pandemic has forced the medical community to re-evaluate each traditional in-person clinical interaction. It will accelerate the adoption of remote technologies, and we are beginning to see this as the HRS, EHRA, APHRS, LAHRS, ACC, and AHA are expected to release their upcoming “Worldwide Practice Update for Telehealth and Arrhythmia Monitoring During and After a Pandemic” guidelines (Varma et al., 2020). Additionally, the current COVID-19 clinical workflow involves self-monitoring at home and then presenting for care when needed. This model is well suited to permeate to other future workflows. In the future, patients may self-monitor cardiovascular symptoms at home with remote monitoring devices and then present as needed, as opposed to fixed-interval clinic visits.

As the global medical community is forced to learn how to treat this novel virus, these devices offer a rapid method to deliver care and conduct novel research. Initial studies have shown the importance of inpatient QT monitoring when treating COVID-19 patients with potential QT-prolonging or arrhythmogenic medications such as hydroxychloroquine and azithromycin (Chang et al., 2020; Roden et al., 2020). However, as more patients are deemed stable for continued care at home, there will be an increased focus on studying patients in the outpatient setting using mobile devices. In light of this, AliveCor received FDA clearance to use their mobile six-lead personal ECG device to monitor QT durations in patients outside the hospital (AliveCor Inc., 2020). As the global medical community studies this in parallel, a new large-scale decentralized approach to collecting research data will emerge leveraging remote diagnostics to collect data from any person in an any location. Thus, remote diagnostics are quickly emerging out of necessity to become a key foundation in the way we do research and manage patients in an increasingly remote telemedicine-based healthcare paradigm.

CONCLUSIONS

There is a growing demand for on-demand healthcare. In a time when consumers have on-demand from all other industries, yearly clinical check-ins are far from sufficient. Rather, devices like this will fill the gap and quench the demand for healthcare. Consequently, a new paradigm of continuous measurement and self-learning will emerge and drive the future of cardiovascular disease management, aided by the rise of remote diagnostic devices.

The post Research Article: A Growing Demand for On-Demand Care appeared first on .

Ashish Kalraiya^1,4, Ben Walker², Shiron Rajendran³, Sayinthen Vivekanantham¹, Ian Gilmour¹, Danny Sharpe¹

¹Imperial College Healthcare NHS Trust

²University of Oxford

³University of Southampton

⁴NHS Innovation Accelerator

Keywords: Covid-19; logistical issues; mobile application; healthcare workers; National Health Service;

Abstract

Background

Covid-19 is exacerbating pre-existing pressures on healthcare systems. Frontline staff are relying more than usual on effective logistics and infrastructure to deliver patient care, for example provision of PPE, stock, facilities and equipment. Staff must adapt their ways of working in response to new challenges. Traditional communication channels within hospitals are often inefficient and not digitised, preventing healthcare organisations from adequately supporting staff and providing efficient solutions to problems.

Objectives

This study deployed the MediShout mobile phone application (app) to capture real-time data, on problems with logistics and infrastructure occurring in hospitals during the Covid-19 pandemic. The main objectives were to determine whether; healthcare staff would use the app, reporting led to immediate improvements, and data-collection could drive long-term transformational change and improve responses to future pandemics.

Methods

The app was used by staff to report issues with logistics and infrastructure across two hospital emergency departments (EDs) at Imperial College Healthcare Trust, UK. These reports were acted upon by senior physicians and nurses, operational managers and service helpdesks. Data was collected from the start of the first peak of Covid-19 in the UK, between March and April 2020. Data from each report were retrospectively analysed across multiple categories, including problem description and time of submission. To gauge the impact of each issue on clinical care, reports were scored against an impact scoring tool using a modified version of the World Health Organisation’s ‘quality of care’ definition.

Results

During this study, 94 reports were submitted. Reporting peaks were observed at times corresponding to clinical handovers. Peaks were also observed when changes had occurred to existing processes within the EDs. Impact analysis highlighted that every report sent had ‘impact’ or ‘significant impact’ on various aspects of care, including efficiency, patient safety and timely treatment.

Conclusions

The MediShout app captured valuable real-time data from frontline staff during the peak of Covid-19. Staff readily adopted the digital technology as it provided a more efficient way to resolve issues. This enabled hospitals to better allocate scarce resources, such as PPE, to those who needed it most. This study suggests listening to the voice of frontline staff during times of crisis allows more effective responses.

Capturing data during pandemics is critical for healthcare organisations to learn lessons and maintain control. During this study, it was established that most problems occurred due to changes in practice, such as dividing EDs into Covid-19 and non-Covid-19 zones, rather than increased caseload. Logistical and infrastructure issues were categorised as being ‘material’ (stock, equipment, medicines, or estates and facilities) or ‘workflow’ (task-management, new ways of working, infection control and communication) in nature. This provides healthcare organisations with a methodical tool for risk-assessing and coordinating future pandemic responses.

Background

Healthcare prior to Covid-19

The healthcare industry is perpetually under pressure to provide high quality, cost-effective, patient-centred care. The demand has gradually been rising over the years due to factors such as an ageing population,[1] the increasing prevalence of noncommunicable diseases [2,3] and the growing burden of largely preventable chronic conditions.[4] Even prior to Covid-19, logistical issues had a significant impact on clinical work with one report highlighting that approximately a third of NHS nurses waste more than one hour per shift finding missing equipment.[5]

Impact of Covid-19

The Covid-19 pandemic has exacerbated pressures already faced by healthcare systems. Globally, Covid-19 has forced healthcare organisations to enter crisis-mode making coordination of responses challenging. In the face of a disaster like Covid-19, frontline staff are even more reliant on well-functioning logistics and infra-structure to deliver care.[6] For example, staff require appropriate infection control measures such as clean working environments and personal protective equipment (PPE) to prevent spread of infection and save the lives of both patients and staff.[7]

The pandemic has forced healthcare organisations to rethink how healthcare is delivered with staff having to radically change their ways of working, often on an hourly basis. For example, elective work has been halted,[8] staff shift-patterns have changed and many clinicians have moved into sub-specialities they’ve not trained in.[9] Factors such as shortage of vital medical equipment, for example ventilators and PPE, are contributing to the psychological burden on healthcare workers.[10] Yet, job satisfaction of healthcare workers is critical for ensuring patients receive the best quality of care and ultimately feel satisfied.[11,12]

Digital Health

As healthcare systems adapt to new working conditions, Covid-19 has rapidly accelerated the need for digital health solutions and innovative technologies.[13] For example, GPs have radically changed their ways of working to adapt to the current crisis, resulting in demand for telemedicine soaring.[14] The importance of data, and not just patient data,[15] in the health and social care industry is becoming more apparent with global technology companies working with NHSx, the National Health Service’s digital branch, to help manage the coronavirus pandemic.[16]

However, many areas of healthcare still lack digital infrastructure and solutions to support frontline staff, who witness problems first-hand and in real-time. For example, most healthcare organisations lack efficient communication channels for staff to rapidly escalate logistical or infrastructure problems to the people or teams who create change. With healthcare staff relying on instant messaging mobile applications such as Whatsapp to communicate at work, the organisations that they work for are not able to respond rapidly or effectively to resolve issues.[17]

This lack of digital presence hugely impacts patient care. In the short-term, issues accumulate and delay staff, whilst in the long-term not collecting valuable data could prevent transformational change and better responses to future pandemics. Thus, whilst healthcare staff should be focused on treating patients, their time is often wasted by logistical and infrastructure issues such as insufficient PPE, estates and facilities problems, faulty IT or missing equipment, which they have difficulties reporting.[5]

MediShout is a mobile phone app that allows healthcare staff to instantly report any logistical or infrastructure problem they encounter to those who create change, such as senior physicians, senior nurses, operational managers and service helpdesk teams. By harnessing the insights of frontline staff, MediShout also hopes to better understand the challenges staff faced during the pandemic.

Objectives

This study aims to implement a mobile phone application (app) to capture real-time data on logistical and infrastructure problems occurring during Covid-19. The main objectives are:

1. To determine if frontline healthcare staff would engage with digital technology during a pandemic, and use a mobile phone app to report logistical and infrastructure problems in real-time.
2. To analyse the impact of problems reported and determine whether reporting led to immediate improvements in healthcare provision.
3. To establish whether reported data can drive long-term transformational change and enable healthcare organisations to respond better to future crises, for example future surges of Covid-19 or new pandemics.

Methods

Data collection

This study collected data using the MediShout mobile app,[18] which was made available to all staff working at the emergency departments (EDs) of Imperial College Healthcare NHS Trust’s two main hospitals in London, United Kingdom. These hospitals were granted free unlimited use of MediShout, with their staff downloading the app and registering with a hospital email account. Staff could report any logistical or infrastructure issue relating to several broad categories; Covid-19, equipment, estates, facilities, stock or IT. The reports were accessed via the MediShout platform by senior members of the ED team; such as senior physicians, senior nurses and operational managers who would resolve issues themself or escalate issues to the relevant service helpdesk team (Figure 1).

Figure 1. The process of creating, resolving and downloading report data.

Data-Analysis

This study analysed data reported from the start of the first peak of Covid-19 in the UK in late March to early April 2020, and this time-period was chosen as it is when hospitals underwent major changes to their normal function. The data was cleaned with duplicate reports removed. A retrospective analysis was performed by comparing data collected within each report (Figure 2); including problem description, date and time stamp, issue-category, location, staff self-reported time wasted by issue and solution where available.

Figure 2. A mock-up view of the reporting interface for users.

Impact-Analysis

To gauge the impact of each issue reported, on clinical care, the authors created an impact scoring tool using a modified version of a World Health Organisation’s ‘quality of care’ definition [19]. This definition lists six criteria to determine ‘quality of care’, but for this study ‘safe’ was sub-categorised as ‘safe for patients’ and ‘safe for staff’ (Table 1).

Table 1. Categories of care quality, modified from the World Health Organisation.[19]

All reports sent via the MediShout app were assessed against each of these categories and scored as 0 (no impact on this category of care quality), 1 (impact on this category) or 2 (significant impact on this category). Therefore, each report had a maximum ‘impact score’ of 14. Four individuals scored the reports independently, and a mean score was calculated for each report.

Results

Data Collection

96 reports were sent from 23 unique users over the period of this study. The maximum number of reports submitted by a single user was 14.

Data-Analysis

Location:

44.1% of issues were reported from green (non Covid-19) areas, 41.9% from the red (Covid-19) areas and the remaining 14% from non-clinical areas such as offices or corridors.

Category:

48.4% of issues were categorised as Covid-19, 27.5% as facilities and estates, 16.5% as equipment and 7.7% as stock.

Staff self-reported time wasted:

35.1% of issues didn’t waste staff time, 29.8% of issues wasted 0-15 minutes, 9.6% of issues wasted 15-30 minutes, 6.4% wasted 30-60 minutes and 19.1% wasted 60+ minutes.

Time of shout:

Figure 3 shows a large peak of reporting between 07:01 and 08:00, and another smaller peak between 19:01 and 20:00. Reporting activity at these times were higher than the daily average.

Date of shout:

The distribution of shouts by date shows three noticeable peaks; March 21, 25 and 31.

Figure 3. Distribution of all shouts per hour, over 24 hours.

Impact analysis

‘Efficient care’ was the aspect of care quality most impacted by the reported issues, with the highest average score of 1.298 out of a maximum of 2 (Table 2). The highest impact score for a report was 13.25, and the lowest was 2.25. The mean score was 7.111 and the median was 7.25. A full frequency distribution of the report impact scores can be seen in Figure 4, and a score for each report is available in Supplementary Figure 1.

Table 2. Average impact scores for each quality of care category. The categories are ranked by their scores.

Figure 4. A frequency distribution (histogram) of the report impact scores.

Analysis showed that reports with the highest impact score would often describe multiple issues within a single message. For example, the report that obtained the highest impact score of 13.25, described several issues such as ‘running low on Covid-19 swabs’, running ‘out/running low on blood cultures/Venturi mask/Venturi adapters’ whilst also highlighting issues about ‘capacity’.

Themes also emerged during free-text analysis which enabled the authors to categorise all reports as being ‘material’ or ‘workflow’ in nature, as seen in Table 3. Material problems are issues with physical aspects of service provision and can be further sub-categorised as stock, equipment, medicines, or estates and facilities. Workflow problems relate to processes and can be further categorised as task-management, new ways of working, infection control and communication.

Table 3. Examples of problems reported, categorised into ‘material’ or ‘workflow’. Quotations have been taken directly from the data and only amended for the purpose of making grammatical sense.

Discussion

The first objective for this study was to assess the ability of the MediShout mobile phone app  to be used by staff to capture real-time data on logistical and infrastructure problems. Around the peak of Covid-19 in the UK, 94 reports were sent using the MediShout app on a wide variety of issues. Staff voluntarily using this digital solution, without any form of direct incentivisation, highlights that they believe this form of communication could benefit their clinical practice.

A large peak of reporting was observed between 07:01 and 08:00, and another smaller peak at 19:01 to 20:00. Reporting activity at these times was higher than the daily average and coincided with the morning and evening handover meetings, where staff discuss both clinical and non-clinical issues. Without the app, staff would have to make time-consuming telephone calls or send emails, which could result in them missing vital parts of the hand-over, going home late or not reporting the issue.

Unreported and unresolved issues would have a huge knock-on effect for other staff, particularly when 65% of all reported problems wasted staff time. 20% of reported problems wasted an hour or more of staff time. The app provided staff with a quicker way of escalating any logistical or infra-structure problems encountered during their shift. This form of communication improved efficiency and saved time, highlighting why healthcare staff happily adopted the digital technology.

Figure 5. Timeline of COVID-19 related events highlighting that as more disruptions occurred in healthcare, more messages were sent using the mobile app. The first and last dates of data collection are shown in green and red respectively.

The second objective was to analyse the impact of reported problems and determine whether reporting led to immediate improvements in healthcare provision. The retrospective impact analysis demonstrated that the app enabled staff to highlight issues that were significantly impacting their ability to provide quality care. MediShout supported hospital teams and enabled them to resolve issues in a more efficient and effective way thus facilitating care improvements.

The majority of reported issues occurred in the two-week period after the healthcare system underwent major changes to its service provision, such as implementing red (Covid-19) areas, stopping elective care activities and requiring staff to wear PPE (Figure 5). The data collected from the app allowed hospital managers to respond rapidly to problems occurring on the frontline as a result of these changes.

By the third week of the study period, coinciding with the peak of the Covid-19 pandemic in London, far fewer reports were sent, indicating that the core issues had been resolved and the EDs were better prepared. By the time the peak caseload arrived, it seems staff were accustomed to the new ways of working and could focus on providing best care. The problems reported seem to be due to the changes in practice, and not related to the actual Covid-19 caseload itself. This implies that, if we can adequately accompany any changes to practice with staff feedback, healthcare environments will be able to respond to and manage crises more effectively.

The final objective was to establish whether reported data can drive long-term transformational change and enable healthcare organisations to respond better to future crises, for example another surge in Covid-19 cases. The data indicates that co-adaptation of frontline staff with their working environment, improves the capabilities of the healthcare system during a time of crisis. The valuable lessons from this study can be extrapolated and applied to other healthcare environments.

When times of crisis or pandemic occur, causing situations to evolve rapidly and change normal service provision, this study recommends that healthcare organisations adopt a methodical approach to managing logistical and infrastructure problems. Organisations should categorise all potential problems, risk-assess them and allocate managers to oversee problems deemed ‘high-impact’. A simple categorization system, based on the data analysed in the study, can be seen in Table 4.

Table 4. A way for healthcare organisations to categorise logistical and infra-structure problems occurring during a pandemic

This study also recommends that during pandemics, healthcare organisations should adopt digital technologies to engage their staff, act upon the problems they see in real-time and use the data to be better prepared next time. During this study, staff in non Covid-19 zones were not initially given PPE however those working in triage used MediShout to highlight the fact they were seeing Covid-19 patients (see Table 3). This consequently led to the hospitals updating their PPE policies, and the staff were appropriately given PPE for protection. Thus, listening to frontline staff enabled rapid responses and better allocation of scarce resources.

Limitations

The quantity and quality of reporting data is dependent on the information sent by staff using the mobile app. Thus, assumptions were made about the accuracy of the reported information. The app highlighted the unique experiences of staff and the problems that they encountered. However, the reported data also suggests that for optimal impact, the data should be considered alongside broader factors that contribute to best patient care. This will enable the full impact of each issue to be explored in more detail. The validity of the impact analysis tool was dependent on the strength of the WHO’s definitions, and the scoring system used to rate impact. Whilst the authors believe that the impact scale provided detailed metrics, this was performed retrospectively.

Future work

There are immediate opportunities for further research by collecting and analysing data from a larger pool of hospitals, and over a longer time frame. In addition, it would be insightful to prospectively understand the true impact of problems reported on wider healthcare systems. A larger quantity of follow-up data could be collected regarding reports and their resolutions, to identify more specific lessons for improving healthcare environments.

Conclusions

The use of the MediShout app in EDs captured valuable real-time data from frontline staff as they responded to the peak of Covid-19. This study indicates that listening to the voice of frontline staff during times of crisis enables healthcare organisations to respond to these challenges more effectively. Data collection is essential in ensuring better control, management and coordination of responses during pandemics and also normal times. The use of MediShout, and the categorisation of problems into material or workflow issues, provides healthcare organisations with a methodical tool for risk-assessing and coordinating future pandemic responses.

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Multimedia Appendix

Supplementary Figure 1. Average impact scores for each category of each shout, and their totals.

Abbreviations

PPE: Personal Protective Equipment

App: Mobile phone application

EDs: Emergency Departments

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