Year: 2021

Categories : COVID Obstetrics & GynaecologyTags :

No COVID Impact on Increased Preterm Births or Stillbirths

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A study found no increases in preterm births or stillbirths during the first year of the COVID pandemic, which will help alleviate concerns around pregnancy and COVID. The large study of more than 2.4 million births in Ontario is published in CMAJ (Canadian Medical Association Journal).

Infection, inflammation, stress, medical or pregnancy-induced disorders, genetic predisposition, and environmental factors are risk factors for stillbirth and preterm birth, although in many instances the exact mechanism is not yet known.

During the COVID pandemic, reports emerged of declining rates of preterm births in countries such as the Netherlands, Ireland and the United States, while the United Kingdom, Italy, India while others reported increases in stillbirths and some variability in preterm birth rates. However, most studies were limited by their small size.

To identify a possible shift, the study researchers analysed Ontario births over an 18-year period and compared these trends in the prepandemic period (2002–2019) with the pandemic period (January to December 2020).

“We found no unusual changes in rates of preterm birth or stillbirth during the pandemic, which is reassuring,” said Dr Prakesh Shah, a paediatrician-in-chief at Sinai Health and professor at University of Toronto, Toronto, Ontario.

It is possible that measures related to the pandemic and compliance with them could affect preterm birth rates in different settings. Thus, the researchers examined birth outcomes in the public health units with higher SARS-CoV-2 positivity rates (Toronto, Peel Region, York Region and Ottawa), and also compared urban and rural births and those in neighbourhoods with different average income levels.

“In some areas and in certain people, the restrictions could be beneficial, and in other settings or individuals, restrictions could have the opposite effect,” said Dr Shah.  

International studies are now underway to help understand the impact of COVID on pregnancy and childbirth around the globe.

Source: EurekAlert!

Categories : COVID General InterestTags :

Japan Tries to Curb COVID with Public Shaming

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A train station in Japan. Photo by Zhipeng Ya on Unsplash

The Japanese government, struggling to control its latest and largest COVID outbreak while maintaining the Olympic bubble, is turning to a new tactic — public shaming.

On Monday, Japan’s health ministry released the names of three people who broke COVID rules after returning from overseas. An official statement said that the three people, two returning from South Korea and one from Hawaii, had clearly acted to avoid contact with the authorities.

All three had negative virus tests on arrival at the airport but thereafter neglected to report their health condition and did not respond to location-monitoring apps or video calls from the health authorities.

In May, the Japanese government had said that about 100 people a day were flouting the border control rules, and warned that it would disclose the names of violators soon.

Japanese authorities are struggling to adapt their COVID response as caseloads surge to their highest levels of the pandemic and vaccinations continue to lag behind other wealthy nations. Public fatigue seems to be setting in from the on-and-off emergency measures the government has imposed in various cities.

And in the face of rising cases, the Japanese government failed to speed up its vaccination campaign. It has maintained that hosting the Olympics inside a tightly controlled bubble, with spectators and athletes isolated from the public, did risk exacerbating the outbreak.

While comparatively few infections have occurred inside the Games, totalling about 300 so far, some Japanese people say that seeing the Olympics held in Tokyo has encouraged them to relax against the virus. The first cases were reported on July 17, with two members of the South Africa soccer team testing positive despite having tested negative on their departure.

Yet the outbreak has continued to worsen. On Tuesday, officials said they had recorded more than 8300 daily cases across Japan, slightly down from the weekend’s record high of more than 10 000. A total of 3709 cases were reported in Tokyo, also slightly lower than previous days.

On Monday the government said that it would hospitalise only those with severe cases of COVID, to avoid increasing the strain on hospitals, suggesting that they are already starting to struggle with the influx of cases.

Source: New York Times

Categories : HospitalsTags :

‘Vast Majority’ of Urine Tests Before Planned Surgery Unnecessary

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“The vast majority” of urine tests conducted prior to scheduled surgeries to check for infections “were not plausibly indicated,” according to US researchers in a study of claims data.

Though the individual tests were inexpensive at $17 each, over the study’s 11-year duration they came to $50 million, plus another $5 million for antibiotics prescribed to patients with no clinical signs of infection.

“Patients and society bear the risk of inappropriate antibiotic use, which can result in adverse drug reactions, increased risk of infections such as Clostridioides difficile, and emergence of antibiotic resistance,” wrote authors Erica Shenoy, MD, PhD, of Massachusetts General Hospital in Boston, and two colleagues in a JAMA Internal Medicine research letter, published in the journal’s ‘Less Is More’ series which highlights overused tests and treatments.

Once, preprocedural urinalyses were routinely done to check for infections that could increase complication risk. However studies have since shown that such testing rarely improves outcomes or even changes clinical management. Organisations such as the Infectious Diseases Society of America and the US Preventive Services Task Force have recommended against testing and prescribing for asymptomatic infections except in certain narrow indications.

To see just how common the practice has been, the researchers used data on some 13 million procedures performed from 2007 to 2017 from Medicare and the IBM Watson Marketscan database of commercial insurance claims, spanning 14 specialties. The researchers did not count kidney and urological surgeries since urinalysis is recommended by guidelines for most such procedures.

Urinalysis was deemed appropriate for the others when urinary tract symptoms, fever, or altered mental state was mentioned. Without those codes, the procedures were “not plausibly indicated.”

While 75% of surgeries in the data did not involve preprocedural urinalysis, suggesting good adherence, in the 25% that did, fully 89% across all types of surgery had no apparent indication; with the lowest non-indicated testing rate being 84%.

The results show that traditional practice patterns “remain entrenched”, according to the researchers, who called on insurers to take more steps to be more aggressive in denying claims for unneeded testing.

Limitations included incomplete patient data as patients may have had legitimate indications for testing and antibiotic prescriptions that were not recorded with the relevant diagnostic codes. Also, about half of the 11-year study period preceded the movement to limit ‘low-value’ testing.

Source: MedPage Today

Categories : Lab Tests and Imaging Neurodegenerative DiseasesTags :

Study Uncovers Assortment of New Biomarkers for Dementia

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Source: National Cancer Institute on Unsplash

An international study identified 15 novel biomarkers that are linked to late-onset dementias. These protein biomarkers predict cognitive decline and subsequent increased risk of dementia 20 years before the disease onset. 

The proteins identified by the study are involved with immune system dysfunction, blood-brain-barrier dysfunction, vascular pathologies, and central insulin resistance. Six of these proteins can be modified with currently available medications.  

“These findings provide novel avenues for further studies to examine whether drugs targeting these proteins could prevent or delay the development of dementia,” explained lead author Joni Lindbohm MD, PhD from the University College London and University of Helsinki.

The study findings have been published in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association.

Pathophysiological research on dementia aetiology has focused on amyloid beta and tau proteins, but thus far prevention and treatment trials targeting these biomarkers have been unsuccessful. This has spurred the search for other potential mechanisms that could predispose to dementia. Recent development of scalable platforms has made it possible to analyse a wide range of circulating proteins, which may reveal novel dementia-linked biological processes.

In this study, the researchers analysed proteins with a novel large-scale protein panel from stored blood samples of the British Whitehall II and US Atherosclerosis Risk in Communities (ARIC) study collected 20 years ago. Using a panel of 5000 proteins, the researchers identified proteins in plasma that predicted cognitive decline in 5-yearly screenings and subsequent onset of clinical dementia. The 15 proteins that were identified were predictive of dementia in both the British and US cohorts.

“This new study is the first step in our 5-year Wellcome Trust funded research programme. We will next examine whether the identified proteins have a causal association with dementia, and whether they are likely to be modifiable, and druggable”, said study author Professor Mika Kivimäki, Director of the Whitehall II study at University College London.

The research programme ultimately aims to identify novel drug targets for dementia prevention.

Source: EurekAlert!

Categories : New Compounds and TreatmentsTags :

New Lupus Treatment Gets the Nod from FDA

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AstraZeneca announced that its type 1 interferon receptor antagonist anifrolumab (Saphnelo) has received approval from the US Food and Drug Administration for the treatment of moderate-to-severe systemic lupus erythematosus alongside standard therapy.

“This is wonderful, exciting news, and is great for the lupus community — patients, family members, and clinicians who treat patients,” said Richard Furie, MD, chief of rheumatology at Northwell Health in Great Neck, New York, in an interview.

Only belimumab (Benlysta) in 2011 and voclosporin (Lupkynis) for lupus nephritis a few months ago had been approved in the past decades. “And that represents 25 years of trying,” Dr Furie said.

Significant benefits were reported in 2016 in a phase IIb trial known as MUSE. In that trial, 62.6% of patients receiving 300 mg intravenous anifrolumab every 4 weeks had an SLE Responder Index score of 4 (SRI-4) plus a reduction in the steroid dose to less than 10 mg/day compared with only 17.6% of patients in the placebo group, which was a significant difference — the best lupus trial data so far, according to Dr Furie.

Two pivotal phase III trials, TULIP-1 and TULIP-2, followed, with conflicting results.

In TULIP-1, the primary endpoint of Systemic Lupus Erythematosus Responder Index (SRI-4) was not met. After a year, an SRI-4 response was seen in 36% of patients receiving anifrolumab and in 40% on placebo. Some secondary endpoints suggested benefits, including the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA).

In TULIP-2, patients were randomised 300 mg intravenous anifrolumab or placebo every 4 weeks for 48 weeks, with a BICLA response as the primary endpoint. After a year, 47.8% of patients in the anifrolumab group achieved a BICLA response compared with 31.5% of placebo patients.

“We were all shocked when TULIP-1 failed,” said Dr Furie, who is also a leading member of the Lupus Research Alliance’s Lupus Clinical Investigators Network. “But it didn’t really fail — it depends on how you define failure. It did not reach the primary endpoint, but on the other composite, BICLA, it was successful, as well as on a lot of the key secondary endpoints. The totality of the data, I think, is the key phrase,” he said.

“I think the two studies were more similar than dissimilar. You have to have an appreciation of how difficult it is doing clinical trials in lupus. For every one trial that has been successful, there have probably been 10 that were unsuccessful,” he said.

This was not the first time discordant results had been seen in lupus trials. “We also saw discordance between the BICLA and SRI in the ustekinumab phase II trial,” he noted.

Source: MedPage Today

Categories : COVIDTags :

Human Rights Commission Inundated with Complaints of Pressure to Vaccinate

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The South African Human Rights Commission (SAHRC) said that it had been inundated with complaints from people who claimed they had been pressured to get a COVID vaccination. These included tenants being threatened with eviction if they did not vaccinate.

Employees and tenants were not the only ones coming forward; companies had also approached the commission for guidance and clarification. The situation is something of a grey area for employers, according to the Department of Labour’s director-general Thobile Lamati.

“Can the employer then force the employees to take the vaccine? This is a very difficult question because we have different work places and different situations,” he said, adding that a worker could not be compelled to take a vaccine without the risks being explained to them.

On Friday morning, acting Health Minister Mmamaloko Kubayi-Ngubane reiterated that vaccination was purely voluntary and confirmed that employers were not allowed to force workers to get the jab.

Nevertheless, the government is encouraging all eligible South Africans to achieve herd immunity, and exit the cycle of waves and economically crippling lockdowns. However, inoculation has not been mandatory, with a target of around two-thirds of the population vaccinated. In a statement, President Cyril Ramaphosa said that only one in ten South Africans now believed that COVID vaccines were not safe.

The commission’s Buang Jones said they would also be examining the reasons given by some people refusing to receive vaccines.

“The reasons may range from medical, religious or other constitutional accounts. But complainants will be requested to take us through their reasoning and the team will be offering advice to those who have complained to the commission.”

Jones said that companies also voiced concerns about the negative impact that COVID had had on their finances.

“That they would like staff to be at work and ensure that the company functions optimally. Their concern is there will be increases in sick leave taken and it will affect production. They are also concerned about the rights of other employees to have chosen to take the vaccine.”

Source: Eyewitness News

Categories : Hospitals Mental HealthTags :

Heavy Workload Reduces Outcomes and Turns Positives into Negatives

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Source: CC0

Employee wellbeing in healthcare is reflected in patient satisfaction, and a new study found that a heavy workload, even positive challenges such as learning new things are experienced as increased stress.

Researchers from the Department of Psychology at the University of Jyväskylä in Finland explored how the staff of a healthcare district experienced increasing job demands, and how wellbeing at work was linked to these demands. The study also clarified whether the demands on employees were reflected in patient satisfaction.

More than a thousand employees took part in the study and evaluated their experiences in a survey measuring intensified job demands, work exhaustion, and work engagement. Additionally, nearly a thousand patients of the healthcare district evaluated their treatment by the healthcare staff.

In line with expectations, healthcare staff’s experiences of greater time pressure and workload were associated with greater exhaustion. An especially high risk of exhaustion was seen in those working in emergency care and nurses.

Additionally, experience of increased job planning demands shared by the working community was associated with greater exhaustion and lower customer satisfaction. This was particularly evident in the staff of leadership services.

“A surprising observation was that none of the intensification demands was positively connected with work engagement,” said Senior Lecturer Mari Huhtala. “In the light of previous studies, employees may find some demands such as learning new things positive challenges, especially when the demands are reasonable. However, this was not the case with the studied healthcare employees. It is possible the general workload in healthcare has led to these positive challenges being experienced as additional stress as well.”

Research data for the study were collected using an electronic survey in the third quarter of 2019. The study will continue in the third quarter of 2021 with the collection of follow-up data.

Source: University of Jyväskylä

Journal information: Huhtala, M., et al. (2021) Intensified job demands in healthcare and their consequences for employee well‐being and patient satisfaction: A multilevel approach. Journal of Advanced Nursing. doi.org/10.1111/jan.14861.

Categories : AgeingTags :

Centenarians’ Unique Microbiomes Protect Against Bacterial Infections

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A new study has discovered that people who live to be 100 or older have a unique microbiome that may protect against certain bacterial infections  including those caused by multidrug-resistant bacteria. The findings, published in Nature, could point to new ways to treat chronic inflammation and bacterial disease.

A team of researchers studied microbes from  faecal samples of 160 Japanese centenarians who had an average age of 107. They found that centenarians, compared to people aged 85 to 89 and those between 21 and 55, had higher levels of several bacterial species that produce molecules called secondary bile acids. Secondary bile acids are generated by microbes in the colon and are thought to help protect the intestines from pathogens and regulate the body’s immune responses.

Next, the researchers treated common infection-causing bacteria in the lab with the secondary bile acids that were elevated in the centenarians. One molecule, called isoalloLCA, was found to strongly inhibit the growth of the  antibiotic-resistant bacterium Clostridioides difficile. Feeding mice infected with C. difficile diets supplemented with isoalloLCA similarly suppressed levels of the bacteria. The team also found that isoalloLCA potently inhibited or killed many other gram positive pathogens, suggesting that isoalloLCA may play a role in keeping the delicate equilibrium of microbial communities in a healthy gut.

“The ecological interaction between the host and different processes in bacteria really suggests the potential of these gut bugs for health maintenance,” said Plichta, a computational scientist at the Broad.

Additional studies from different regions around the world with more participants and longer duration could help find a causal link between longevity and bile acids. The bacteria identified in this study could help researchers in the meantime discover how to treat infections caused by antibiotic-resistant bacteria by manipulating bile acid.

“A unique cohort, international collaboration, computational analysis, and experimental microbiology all enabled this discovery that the gut microbiome holds the keys to healthy aging,” said co-first author Xavier, core institute member at the Broad. “Our collaborative work shows that future studies focusing on microbial enzymes and metabolites can potentially help us identify starting points for therapeutics.”

Source: Broad Institute of MIT and Harvard

Journal information: Sato Y, Atarashi K, et al. Unique bile acid-metabolizing bacteria in centenarians’ microbiome. Nature. Online July 29, 2021. DOI:10.1038/s41586-021-03832-5

Categories : Ethics and LawTags :

Pharmaceutical Companies Score Weak on Data Transparency

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Clinical trial data helps in deciding prescriptions and is good for science, but a new study revealed that not many pharmaceutical companies are completely transparent with the development data for their products. The study also found that large companies are much more transparent than smaller ones.

The study, co-authored by Yale researchers and published in The BMJ Open, assessed the data-sharing practices of 42 pharmaceutical companies for clinical trials of 40 novel drugs and 22 biologics which received US Food and Drug Administration approval in 2016 and 2017. They were evaluated with the Good Pharma Scorecard, which consists of transparency measures and a ranking system.

The researchers found that only seven of the 42 companies (17%) entirely met the tool’s standards for transparency and sharing data, with smaller companies being particularly opaque.

“The non-large pharmaceutical companies are dragging down the sector, often failing to meet federal reporting requirements, much less voluntary standards,” said study co-author Jennifer Miller, assistant professor at Yale School of Medicine, founder of Bioethics International.

“The lack of transparency is a problem because access to robust clinical-trial data supports patient care and good science,” she added. “Full transparency allows scientists to learn from previous work and prevents people from being exposed to unnecessary experiments.”

From the late 1990s, requirements for pharmaceutical companies to register and report results from clinical trials have been increasing. However, not all companies fully comply with the rules and industry guidelines vary.
In a smaller 2019 study using the transparency scorecard, 25% of companies fully met the standards, which include registering clinical trials, sharing data and study protocol publicly, and annually reporting requests for data. When given a 30-day window to improve, 33% met the standard.

For the latest study, the researchers also included biologics and smaller companies. While 17% of companies had perfect scores, 58% of the companies assessed had publicly available results for all patient trials, 42% complied with federal reporting laws, and 26% met the scorecard’s data-sharing measure.

Non-large companies were less responsive than large companies when offered the 30-day window to fix errors and improve data-sharing practices. Four companies used the window to improve data-sharing procedures

“It’s not surprising that non-large companies lag behind large as they may have fewer resources and smaller staffs with less compliance experience,” Miller said. “Our findings suggest that large companies may benefit from reviewing the transparency procedures of smaller companies before partnerships, mergers, and acquisitions so they don’t inherit any deficiencies.”

The researchers did notice improvements among large companies between the 2019 study and the latest one. For example, the median data-sharing score for large companies increased from 80% for drugs approved in 2015 to 100% for products approved in 2017.

Source: Yale University

Journal information:  Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis, BMJ Open (2021). DOI: 10.5061/dryad.r2280gbdb

Categories : COVIDTags :

Breakthrough Infections Among Vaccinated Alarmed CDC

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Image source: CDC/Unsplash

Three-quarters of COVID cases were among the vaccinated in an outbreak during large public gatherings at Cape Cod island in Massachusetts, USA, with the Delta variant predominating, researchers found. This helped reverse the official US recommendations on mask-wearing when fully vaccinated.

Of 469 cases linked to numerous summer events and large summer gatherings in a small town, 346 (74%) happened in fully vaccinated people, and almost 80% of those cases were symptomatic, reported Catherine Brown, DVM, of the Massachusetts Department of Public Health, and colleagues.

There were five hospitalisations, four among fully vaccinated people, and no deaths. Of 133 cases with sequence information available, 89% were from the Delta variant, the authors wrote in the Morbidity and Mortality Weekly Report.

Moreover, vaccination coverage in Massachusetts was reported to be 69% as of July 3, they noted.

The data on this outbreak, along with the Delta variant, reportedly motivated the Centers for Disease Contol’s change in indoor masking guidance earlier last week. 

CDC Director Rochelle Walensky, MD, noted that “rapid receipt and review of unpublished data” contributed to the guideline change.

The authors found that RT-PCR cycle threshold (Ct) values in vaccinated and unvaccinated people were comparable. Pointing to these high viral loads among the vaccinated in this case, Dr Walensky said it suggested that vaccinated individuals infected with Delta could still transmit the virus.

“This finding is concerning and was a pivotal discovery leading to CDC’s updated mask recommendation,” she said, saying it was “updated to ensure the vaccinated public would not unknowingly transmit virus to others, including their unvaccinated or immunocompromised loved ones.”

The authors detailed increased reports of COVID cases in Barnstable County, beginning on July 10, including those who were fully vaccinated. Many COVID patients reported attending large indoor and outdoor gatherings.

They identified a cluster of cases, 346 of them fully vaccinated, in Massachusetts residents, who tested COVID positive 14 days or sooner after travel to or staying in Barnstable County.

Cases were also reported from residents of other states who traveled to this town during the period, and reports of secondary transmission.

The authors urged stricter prevention measures at such events, given, “the potential risk of infection during attendance at large public gatherings that include travelers from many areas with differing levels of transmission.”

Source: MedPage Today

Journal information: Brown CM, et al “Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings – Barnstable County, Massachusetts, July 2021” MMWR 2021; Published July 30, 2021.