Tag: healthcare industry

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Court Rules that UTI Drug Trade Names are Too Similar

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A court case over the trade names of two urinary tract infection (UTI) drugs has been settled. The court ordered that Cipla Medpro be restrained from using the trade name Furizome as it is too similar to Adcock Ingram’s UTI drug Urizone, leading to potential confusion by consumers. In his ruling, Justice James Lekhuleni of the High Court, Western Cape Division, who stated that despite safeguards against confusion in prescribing, ultimately “doctors are human”, so miscommunications could occur – and that the agency of patients cannot be ignored.

The trademark infringement case was brought by three applicants Adcock Ingram Limited, Adcock Ingram Healthcare (Pty) LTD, and Italian company Zambon S.P.A was listed as the third applicant, being the owner of the name Urizone used under licence. Urizone had been launched in South Africa in 1993. The applicants stated that more than 3 million sachets had been sold between 2011 and 2023, with R5 million in advertising spent to promote the drug between 2018 and 2022 alone.

The applicants brought the case that Cipla Medpro’s Furizome, with the active ingredient fosfomycin, was too similar to their own product, Urizone, which contained the same ingredient in 3g sachets, and thus could confuse consumers. They alleged that Cipla Medpro sought to capitalise on the reputation earned by Urizone.

The applicants made the case that, despite Urizone being made available as a generic, none of the pharmaceutical companies producing it chose to use the name. When Furizome was launched, Adcock Ingram sent a letter of demand to Cipla to stop using the name due to its . Cipla, through its attorneys, rebutted the claim, saying that the two are sufficiently distinct to avoid confusion, with the “F” alluding to the fosfomycin ingredient. Cipla contended that it had already submitted the name through SAHPRA, and

Cipla also contended that the consumer – the patient – would not be misled during the prescribing and purchase of a schedule 4 medication as they would be informed by the pharmacist of the two different drugs.

In considering the judgment, the court noted that a test as to whether trademarks are be similar can be mode on a phonetic basis, or if they conceptually or visually similar. A trademark’s essential function is to indicate the origin of the goods in connection with which it is used. The “N” and “M” where seen as visually and phonetically similar, and “furi” was similar phonetically to “uri“. This could cause confusion and miscommunication even between doctors as to what drug they had prescribed a patient.

While Justice Lekhuleni acknowledged the safeguards of prescribing schedule 4 medications, he pointed out that the general public had become much more knowledgeable about prescription drugs in the past two decades. On this, he wrote “…the reality is that patients are involved in the process of deciding which medicines they will use, and that creates the risk of confusion. This situation in turn creates a responsibility upon pharmaceutical companies to make sure that they adopt trade marks that are not confusingly similar.”

Categories : Hospitals Medical IndustryTags :

Life Healthcare Delivers Strong Results on Healthy Southern Africa H2-2024 Performance and Thriving International Sales

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JOHANNESBURG, 26 November 2024 – Life Healthcare Group has delivered a robust operating performance for the year ended 30 September 2024, marked by a strong second-half (H2-2024) performance in its southern Africa operations and exceptional growth in its international Life Molecular Imaging (LMI) business. Group revenue grew by 12.7% year-on-year.

In southern Africa, Life Healthcare experienced a strong second half performance, particularly within its acute and complementary business. Acute-hospitals paid patient days (PPDs) grew 1.6% and occupancies reached 68.7% for the year with the second half delivering occupancies of 70.7%. This positive momentum resulted in a 7.7% increase in revenue, with H2-2024 revenue growth of 9.3%. Strategic partnerships with funder networks further cemented Life Healthcare’s position as the preferred hospital network for leading medical schemes.

LMI, the Group’s international operation, saw revenue grow by 181.3%. This was thanks to a 91.9% surge in doses sold of Neuraceq© – the company’s positron emission tomography (PET) diagnostic-imaging tracer, used in the Alzheimer’s diagnostic field. Additionally, LMI successfully secured a sub-licensing agreement for one of its early-stage diagnostic and therapeutic novel isotope products, RM2. This transaction delivered a $36 million (R665 million) upfront payment with further milestone and royalty payments to follow. This transaction elevated the LMI normalised earnings before interest, taxes, depreciation, and amortisation (EBITDA) to R637m.

Peter Wharton-Hood, Chief Executive of Life Healthcare Group, commented, “Our Group maintains a solid financial foundation, characterised by a fortress balance sheet and minimal gearing, which allows us to strategically invest in expansion opportunities across our diversified portfolio. We are particularly encouraged by our second-half results in southern Africa and the ongoing success of LMI as well as the extraordinary distribution to shareholders over the year. Our focus remains on delivering superior patient care and broadening access to essential and complementary healthcare services.”

Group revenue from continuing operations reached R25.5 billion (2023: R22.6 billion), with southern African revenue contributing R23.7 billion (2023: R22.0 billion), and international operations R1.8 billion (2023: R656 million).

Life Healthcare’s net debt to normalised EBITDA is at a healthy 0.45 times. Cash generated from continuing operations was R4.3 billion and available undrawn bank facilities amounted to R2.3 billion.

The Group’s total EPS increased by more than 1000% to 328.8 cents per share but this does include the profit on the disposal of Alliance Medical Group (AMG) (a profit of R2.8 billion). Excluding this profit and some small impairments the HEPS increased by 73.4% to 152.9 cents (2023: 88.2 cents). The best measure to reflect the Group’s strong financial performance for the year is normalised EPS excluding the benefit from the RM2 transaction, this reflected an increase of 14.5% to 132.3 cents per share.

The Group received R10.2 billion in net cash proceeds from the disposal of AMG, after the settlement of all offshore debt and transaction costs. A special dividend of R6 per share (R8.8 billion) was paid on 8 April 2024 from these proceeds.

The Life Healthcare Group board declared a final cash dividend of 31 cents per share, an increase of 14.8% over the prior year, and a special dividend of 70 cents per share. Total distributions for the year, including special dividends, amount to R10.6 billion.

“We are delighted with our progress in the acute, complementary, and pharmaceutical sectors,” remarked Wharton-Hood. “Our strategic funder network partnerships position us as the preferred choice among leading medical schemes. Our robust financial assets and prudent cost management will continue to support our capital expansion initiatives across all business areas. Exciting times lie ahead for Life Healthcare Group, and these results reflect that promise.”

Categories : Hospitals Medical IndustryTags :

Health Care Integration Sees Ballooning Costs for Minor Care Benefit

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Over the past few decades, health care integration has absorbed physician practices and hospitals into large health systems, a practice which was heralded as the way to cut health care costs and boosting quality of care.

But integrated health systems appear to be failing on both fronts, according to the results of a new US study published in JAMA. For patients in health systems, care is only marginally improved while costs are significantly higher compared to those at independent practices or hospitals.

In the US, health systems have grown exponentially in size and market share through mergers and acquisitions of physician practices and hospitals and the joining of separate health systems.

Proponents of consolidation have argued over the years that physicians and hospitals working together in integrated, coordinated systems provide better patients care while being more efficient than independent physician practices and hospitals. This would drive quality of care up while keeping spending steady and even driving costs down.

“One of the key arguments for hospital mergers and practice acquisition was that health systems would deliver better-value care for patients. This study provides the most comprehensive evidence yet that this isn’t happening,” said study first author Nancy Beaulieu at Harvard Medical School.

Today, these systems are responsible for a large proportion of the medical care delivered in the US, some employing thousands of physicians. But despite their impact on population health and the economy, little is known about the actual performance of integrated health organisations, the study authors noted.

A lack of detailed data on performance and scale is a key obstacle. The current analysis is believed to be the first comprehensive national study to compare outcomes between patients receiving care within health systems and outside of them, including patients with private insurance as well as traditional Medicare, which is the US health insurance system for those over 65 or which certain disabilities or conditions. 

The analysis included a total of 580 health systems, accounting 40% of physicians and 84% of general acute care hospital beds. Academic and large nonprofit systems accounted for a majority of system physicians (80%) and system hospital beds (64%).

System hospitals were larger than hospitals than nonsystem ones, with 67% of system hospitals having more than 100 beds, while only 23% of nonsystem hospitals having more than 100 beds. System physician practices were also more likely to have more than 100 physicians compared with nonsystem practices (74% vs 12%). Integrated systems delivered primary care to 41% of traditional Medicare beneficiaries.

As for quality and cost of care delivered within systems, patients with primary care physicians in health systems reported slightly better satisfaction and overall care experience than patients of independent physicians.

This is the case even though many patients with nonsystem primary care providers also receive some of their care in hospitals or specialist practices that are part of a health system. However, care in systems came at a much higher price, contributing to higher overall spending on health care, the research showed.

Prices for services from physicians and hospitals within health systems were significantly higher than for independent healthcare, the study found. Physician services delivered within health systems cost between 12% and 26% more, compared with independent practices. System-based hospital services cost an average of 31% more than care delivered by independent hospitals.

Small differences in quality combined with large differences in cost of care suggests that health systems have not, on average, realised their potential for better care at equal or lower cost, the researchers said.

Members of the research team have compiled a database from various sources to help characterise these health systems and to link claims data with information on health care providers in and out of health systems. The database, housed at NEBR, will be made available for free to other researchers in the near future.

“There’s no question that large, sophisticated health systems have benefits over independent systems,” said study author David Cutler, Harvard economic professor. “Big systems tend to be less vulnerable to economic downturns and they can provide specialised care that would be difficult to maintain in smaller systems. But the hoped-for cost savings benefits of integrated health systems have not yet materialised.”

Source: Harvard Medical School

Categories : Hospitals Medical Research & TechnologyTags :

The Pros and Cons of Robotics in Healthcare

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Having to cope with the strain of COVID on an already fragile healthcare system, a few hospitals in the Western Cape have been introducing robotics for specialised tasks – but are they worth the hype?

Robotics was able to fill an unprecedented need during the COVID pandemic – the ability to remotely conduct ward rounds from remote locations. Tygerberg Hospital made use of ‘Quintin’, a robot that is essentially a tablet on a mobile stand that allows users to remotely communicate and inspect the area, but it can’t physically interact with its environment.

Robotics offers greater surgical precision, which may translate into reduced healthcare load. IOL reported that the provincial Department of Health plans to use a pair of new robotic surgery machines installed at the Groote Schuur and Tygerberg hospitals to fast-track surgeries and address the province’s surgical backlogs caused by COVID. These robotic surgery units will be used for procedures on colorectal, liver, prostate, kidney and bladder cancers, and women with severe endometriosis. In the province’s private sector, Netcare Christiaan Barnard Memorial Hospital also makes use of robotic-assisted surgery.

Robotic surgery has a number of advantages. The small robotic arms allow for smaller incisions and faster recovery times, reducing the strain on hospitals. A liver resection that would have a patient in hospital for a week can be reduced to one or two days with robotic surgery. More complex surgery becomes possible, eg in difficult to access areas or in patients with obesity. Robotic surgery allows surgeons to be off their feet, easing an extremely fatiguing job, and the software automatically compensates for any tremor in the surgeon’s hands.

However, robotic surgery still has drawbacks – chief among them is cost and the need to have trained personnel to operate them. There is also some latency between the surgeon’s hands movements and the corresponding movement of the robot, leading to possible errors. Shorting of the electrical current running through the robotic arms can also cause burns to the patient’s tissue, and there is also the possibility of nerve compression injuries due to the positioning of the patient. Furthermore, operator errors, especially when operators are inexperienced or robotic surgery is performed in lower volumes, is always a possibility.

Robotics have promising applications in sanitation – they can easily disinfect areas using UV light, for example – and can also assist nurses with certain tasks, such as making a 3D vein map prior to a venipuncture. Some robots can even assist the elderly, conversing with them and can perform simple tasks like calling a nurse. Other applications include the much simpler technology of exoskeletons, a wearable frame which amplify users’ strength (though nowhere near that of the fictional Iron Man) and are useful in rehabilitation and for enhancing mobility in the elderly. Other applications include increasing strength of care staff for assisting patients, freeing up other staff.

Some exoskeletons are even purely mechanical, merely readjusting loads without any sophisticated electronics or motors. Yet even these are prohibitively expensive: the Phoenix Medical Exoskeleton goes for about US$30 000 each.

While promising, robotic systems are at present still hugely expensive, limited in function and can only assist with a small fraction of the tasks that healthcare workers perform. Even if the cost could be reduced enough to help ease healthcare worker burden in South Africa to help, that still leaves the problem of enough experienced and motivated healthcare workers, beds and neglected rural areas.

Categories : Healthcare Politics and Regulations HospitalsTags : 1 Comment

Exodus of Healthcare Professionals as NHI Introduction Nears

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Stethoscope
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The prospect of an exodus of doctors and other key healthcare personnel from South Africa ahead of the planned introduction of the National Health Insurance (NHI) scheme has prompted concern among healthcare stakeholders.

In addition to the loss of skilled healthcare professionals, there is also a growing concern that the country could lose valuable training skills as professionals look to leave.

Thirteen years on from its inception, the NHI continues to suffer from the same criticisms. A May 2021 research paper [PDF} found that South Africa’s per capita spending on public healthcare was higher than even wealthier developing countries, yet it ranked near the bottom for measures of healthcare outcomes.

An informal poll on the QuickNews website in March showed that 81% of respondents had at least considered emigrating due to the planned introduction of NHI.

Professional associations are also warning of an exodus with the start of NHI. The South African Medical Association (SAMA) has said that its members cannot support the NHI in its current form.

This stems from a deep-rooted lack of confidence in the capacity of government and its financial ability to ensure the service is successful, the association said. Other concerns that members have raised include only providing emergency treatment to refugees and illegal immigrants, as well as their children.

SAMA conducted a survey which showed that up to 38% of its members plan to emigrate from South Africa due to the planned introduction of the NHI.

6% of members said that they plan to emigrate for other reasons, while 17% of doctors said that they were unsure about leaving the country. Many doctors have said that the aim should rather be to get the public sector to a state where it can appeal to private sector patients.

They added that there should be engagement with private doctors to provide additional services funded by the state. The group also called for a proper pilot of the proposed systems and payment mechanisms.

The Department of Health noted these concerns in a parliamentary briefing this week, noting that skilled personnel will be needed for the NHI to work. It added that this was not limited to healthcare professionals, but that general skilled human resources will be central to the health system going forward.

It added that the complex interactions between training, registration compliance and employment can all be greatly improved.

“This is a big ship that will need to be turned, but the framework is in place,” said acting director-general of health Dr Nicholas Crisp. “We have heard the threats that there will be an exodus of personnel if the NHI is implemented and a brain drain.”

The department is actively responding to this, he said, with a framework in place to ensure the country retains the necessary skills. A ‘Human Resources for Health strategy’ before was already under development before the start of the COVID pandemic, he added.

This framework sets out a multi-work implementation plan, but it requires money and investment in the health workforce to ensure the country is ready for universal health coverage, Dr Crisp said.

“Every health professional has a place in the National Health Insurance – whether you choose to work in the public portion of the delivery system or the private portion of that delivery system.

“We do not think there needs to be a threat on anybody, or their viability, or their role to be played.”

Source: BusinessTech

Categories : General Interest Healthcare Politics and RegulationsTags :

NHI Faces Healthcare Human Resource Emigration Challenges

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While the proposed National Health Insurance (NHI) could make use of existing private healthcare human resources, the necessary tax increases to fund it could drive more healthcare professionals from the country, the Professional Provident Society (PPS) has said.  Economic and other factors, such as the Durban unrest, have already caused a surge of emigrations of professionals since July last year. In addition, foreign students graduates who study critical skills in South Africa (such as nurses and GPs) will no longer have an easy route to permanent residency. 

The PPS, which counts about 30 000 healthcare professionals among its membership, pointed out the vulnerability of South Africa’s tax base – which has shrunk to only 6.9 million taxpayers, down from 7.6 million the year from the year before.

While it raised a number of concerns about the NHI, the group stated that it was broadly supportive of establishing universal healthcare in the country, and this goal could still be accomplished by using a dual public-private system. The PPS further noted that the government could benefit from the exceptional administrative capabilities and existing patient management systems.

However, NHI is dependent on strong, competitively remunerated human resources, with PPS pointing out that “South Africa has experienced a mass exodus of nurses in the 90s; we cannot risk that again. Both the government and private sector need to find a solution for South Africa and it cannot ‘import solutions’.”

“Professionals are a big proportion of healthcare delivery and the tax base. Their voices need to be considered.

“We urgently need to see the funding model, the implementation of the Health Market Inquiry (HMI) and details of how the system will work.”

The PPS said in a 2019 report that the highest risk to effective universal health cover in South Africa is losing highly skilled professionals to emigration. Healthcare professionals have a great deal of geographic freedom, and it is becoming easier to work in their trades the world over. COVID with its restrictions may have slowed emigrations by skilled professionals, but since July 2021, experts have seen a surge backed up by 18 months of pent-up demand. 

The PPS noted that research has shown “that the decision to emigrate is a complex one that is driven by various personal and societal pull and push factors.”  The NHI could be yet another push factor adding to the list of healthcare professionals’ sore points. “Healthcare worker migration from South Africa in the past has been driven by policy decisions and socio-economic and political considerations.

“In 2001, the number of nurse emigrants was roughly 20% of the total number working within the public sector in South Africa. That, together with being ranked as having the eighth-highest global number of emigrating physicians in the year 2000, created a dire situation for the sustainability of healthcare in South Africa at the time.”

Among general professionals, PPS’s research has indicated that many are considering emigration. A majority of respondents surveyed (73%) cited NHI as a potential reason for emigration, with 15% unsure and only 12% not considering leaving at all.

In addition to losses from emigration, the Department of Home Affairs has ended a 2014 waiver which allowed a quicker path to a residency permit for foreign students who acquire critical skills in South African higher learning institutions. Going forward, foreign students will no longer be able to apply for permanent residency visas without complying with the usual requirements such as providing proof of five years’ work experience. This is seen as detrimental to South Africa’s ability to attract and retain skilled professionals. This may further impact NHI implementation as the necessary skilled human resources are squeezed further as fewer foreign students may choose to study and then work in South Africa.

Source: BusinessTech

Categories : HospitalsTags :

Netcare Seeking a Buyer for Bougainville Hospital

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Credit: Netcare

Netcare is looking for a buyer for its 60-bed Netcare Bougainville Hospital in Pretoria West, which first opened its doors in 1997.

Commenting on the development, Johan Smal, regional director of Netcare’s North East region said that unless a suitable buyer was found, the hospital would close its doors on 30 April 2022.

In outlining the reasons for the closure of the facility, Smal said that Netcare’s hospital division continually conducted strategic reviews of its asset portfolio in which Netcare Bougainville Hospital was identified as an under-performing facility for a sustained period.

“The hospital’s under-performance has prevailed from before COVID and this was further exacerbated by the adverse effects of the pandemic, in the past 24 months. These and other circumstances have rendered it uneconomical to retain Netcare Bougainville Hospital in the current business environment.”

“We have been in consultation with staff, doctors and facility management to notify them that the hospital may have to close. In addition the Department of Health, unions and other key stakeholders have been kept firmly updated on developments,” he added.

Sydney Masalla, general manager of Netcare Bougainville Hospital has confirmed that there are at present only three resident specialists on site at the hospital who also work at other facilities.

“In addition we have only 37 active staff members with whom we are in discussion regarding viable alternative employment options.”

Smal concluded by thanking patients, doctors, staff as well as healthcare service providers for their support through the years stating that they were an integral part of the history of Netcare Bougainville Hospital and the greater South African landscape.

“I am confident that we will continue working together, as we have in the past, in other Netcare facilities – this is therefore not farewell,” he concluded.

Categories : COVID Healthcare Politics and RegulationsTags :

Vaccine Patent Waivers are No Silver Bullet, Experts Argue

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Rather than a World Trade Organization (WTO) patent waiver, COVID vaccine equity requires improvements to manufacturing and distribution of vaccines in the Global South and compulsory licensing mechanisms, according to a statement by ALLEA, the European Federation of Academies of Sciences and Humanities. 

They state that the low level of COVID vaccination in the Global South is ethically unacceptable and risks prolonging the pandemic. At the end of 2021, access to Covid-19 vaccines is still a priority. Only 5.9 % of people in low-income countries have received at least one dose (on 29 November 2021, compared with 0.3% on 14 April), with numbers in Africa remaining very low, save for Morocco. The patent waiver being discussed within the WTO since 2020 will not solve these vaccination bottlenecks in the short-term. For instance, the waiver as proposed by South Africa and India would in practice require unanimity between the 164 WTO Members to be adopted – to achieve this in practice would simply delay the waiver until after the pandemic.

Rather, measures should be undertaken to accelerate local manufacturing and distribution of vaccines in low- and middle-income countries (LMICs), ramp up investment in vaccination campaigns, and facilitate the compulsory licensing of patents and knowledge transfer.

In particular, the statement advocates for (i) practical measures that could accelerate the production, export, distribution, and administration of vaccines worldwide and ii) an international mechanism affording additional scrutiny of the manufacturing bottlenecks combined with new measures in the intellectual property (IP) framework such as flexibility for the compulsory licensing of patents.

According to the experts, the current co-sponsored waiver proposal at the WTO is “not well-tailored to the urgent vaccine problem” and needs additional national legislation to have any practical effect. A WTO waiver would only remove the obligation for WTO Member States to grant IP protection, but would not ensure that stakeholders can effectively benefit from the invention and related know-how.

“A waiver (in the sense of the co-sponsored proposal at the WTO) of IP protection, including of trade secrets, would never make this know how publicly accessible, but only remove the possibility for companies enjoying confidentiality protection to sue for trade secret infringement”, the experts argued.

Other IPR measures need to be considered instead, with the WTO waiver debate raising other IP fixes that are needed in the field of health. The WTO rules on compulsory licensing of health-related patents should be amended. Important adjustments to patents and trade secret protections should also be adopted by the EU, its Member States, and other countries. In particular, improved procedures and institutional design should help to streamline the process for compulsory licensing on pharmaceutical products, including vaccines.

Source: ALLEA

Categories : Ethics and Law Medical Research & TechnologyTags :

Fraud Trial of Theranos Boss Begins

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On Wednesday, the trial of Elizabeth Holmes, founder of medical technology company Theranos, began. Prosecutors alleged she “lied and cheated” for money and fame.

Ms Holmes faces 12 fraud charges over her role at the failed company which was once worth $9bn, facing up to 20 years in prison if found guilty.

She is accused of deceiving patients and investors about the company’s testing technology, which was claimed to diagnose basic illnesses from a few drops of blood. Her defence team argues that she was naive and her company simply failed.

“Failure is not a crime. Trying your hardest and coming up short is not a crime,” said defence lawyer Lance Wade in his opening statement on Wednesday.

Former Theranos executive Ramesh “Sunny” Balwani faces the same charges next year. He was romantically involved with Ms Holmes.

Ms Holmes, who founded Theranos in 2003 aged 19, was dubbed the world’s youngest self-made female billionaire and hailed as the “next Steve Jobs”.

In 2015 and 2016, investigations by the Wall Street Journal revealed Theranos’ blood-testing devices did not work and the company was doing most of its testing on commercially available machines made by other manufacturers. She initially denied these reports.

Prosecutor Robert Leach alleges that, after running out of funds, Ms Holmes and Mr Balwani turned to fraud in 2009, lying about the tests and exaggerating the firm’s performance. Mr Leach said this included falsely claiming the tests were vetted by Pfizer and being used by the US military.

The case will probably take months and Ms Holmes will likely take the stand — a necessary gamble in the face of overwhelming evidence that the technology did not work.

Ms Holmes “dazzled” Walgreens into using the company’s services, and the company brought her fame.

“She had become, as she sought, one of the most celebrated CEOs in Silicon Valley and the world. But under the facade of Theranos’ success there were significant problems brewing.”

 The defence’s Mr Wade said Ms Holmes “naively underestimated” the business challenges but did not attempt to defraud investors. Ms Holmes has also alleged years of emotional and psychological abuse by Mr Balwani, who has denied the allegations. She is likely to testify as to how this affected her.

Source: BBC News

Categories : HospitalsTags :

Sleep Deprivation Common in Surgeons, Impacting Performance

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New research has found that surgeons were sleep deprived prior to on-call shifts and afterwards even more so, and crucially, that sleep deprivation impacted surgical performance. 

The study is the first to focus on Irish surgeons and is published in the Journal of Surgical Research. A separate study found that short naps of 30 to 60 minutes do little to reduce sleep deprivation.

Focussing on the effects of being ‘on-call’, a frequent state for surgeons, the study explored subjective and objective metrics around sleep and performance using ‘on-call’ as a particular influencer for increased fatigue.

Surgeons frequently work 24 straight hours (or more) resulting in unavoidable sleep disturbance. This is partly due to historical associations of the Halstedian Era of Surgery to ‘reside’ in the hospital in order to properly learn, but also current staffing levels mandating surgeons to complete regular on-call work.

Participants were hooked up to electroencephalogram (EEG) machines and a validated modified Multiple Sleep Latency Test testing was used to objectively measure sleep on the morning of their on-call shift. The researchers also record other validated tests for subjective sleep and fatigue measurement. ‘Sleep latency’ refers to the time it takes to go from being fully awake to sleeping and is often an indicator of sleepiness. The surgeons in the study had early onset sleep latency before on-call, which was exacerbated further in post-call settings.

Performance was measured with standardised and validated tools. Technical performance of surgeons was assessed using the validated Simendo © surgical simulator, while cognitive performance was measured using the Psychomotor Vigilance Task (PVT) to assess objective alertness and reaction time, a known aspect of cognitive performance.

The study is the first to attempt to control for a series of confounding variables such as experience, quality and quantity of sleep, the influence of caffeine and circadian rhythm influences.

The study found that:

  • Surgeons had poor baseline sleep quality and were objectively sleep-deprived, even pre-call, when they should be in a ‘rested state’.
  • In all study participants, early onset sleep latency was seen in pre-call settings and worsened in post-call settings.
  • Early onset sleep latency was worse in trainees compared to consultants, though both groups experienced early onset sleep latency post-call.
  • As sleep-deprivation increased, diminished performance was seen in cognitive tasks and surgical tasks with greater cognitive components.
  • Higher levels of self-reported fatigue and daytime sleepiness were recorded post-call.

Technical skill performance was relatively preserved in acutely sleep deprived states but may be influenced by learning curve effects and experience in surgical tasks.

Existing models of surgical on-call were not conducive to optimising sleep for surgeons, the research found. But making changes for better sleep has challenges, such as loss of continuity of patient care, loss of trainee exposure, and reduced service delivery.

Dale Whelehan, PhD researcher in Behaviour Science at the School of Medicine and lead researcher commented: “The findings of this study tell us that current provision of on-call models preclude the opportunity for surgeons to get enough rest. Similarly, surgeons are sleep deprived before going on-call which further perpetuates the issue. The implications for performance suggest aspects of surgeons performance is diminished, particularly tasks which might be more cognitively demanding. 

“We need meaningful engagement from all stakeholders in the process, working towards the common goal of optimising performance in surgeons. This involves looking at the multifactorial causes and effects of fatigue. Part of that discussion involves consideration around how current models of on-call influence sleep levels in healthcare staff, and how it creates barriers to fatigue management in staff.”

Professor Paul Ridgway, Department of Surgery at Trinity, who supervised the study, said: “Our study is further evidence that the way we deliver emergency work alongside normal work in Ireland has to change. We need to learn from our colleagues in aviation who have mandatory rest periods before flights.”

Source: Trinity College Dublin