Body

Researchers from Hong Kong Baptist University (HKBU) and the Faculty of Medicine at The Chinese University of Hong Kong (CU Medicine) have jointly developed the Spermine Risk Score which, coupled with the use of a urine test, provides a non-invasive and more reliable method for the diagnosis of prostate cancer. In a study conducted by the researchers, about 37% of the patients, who were ultimately found to have no prostate cancer, can avoid undergoing a prostate biopsy procedure. The findings have just been published in the scientific journal Prostate Cancer and Prostatic Diseases.

Demand for more reliable and non-invasive diagnosis

Prostate cancer is the third most common and the fourth most fatal cancer for the male population in Hong Kong. It results from the abnormal and uncontrolled growth of the prostate gland. Two medical procedures are commonly used for its diagnosis, namely the digital rectal examination (DRE) and the serum prostate-specific antigen (PSA) test.

DRE is performed by a doctor who uses a gloved finger to check the back portion of the prostate. Its accuracy highly depends on the skill and experience of the doctor. The PSA test, a kind of blood test, is a more popular alternative. For the Asian population, individuals with a PSA level higher than 4 ng/mL are normally interpreted as having a high risk of prostate cancer, and a prostate biopsy for further confirmation is usually recommended. According to the Centre for Health Protection of the Department of Health, about three out of four men in this group do not have prostate cancer. However, the patients have to bear the risk of complications due to the invasive nature of the prostate biopsy procedure.

Prostate cancer patients have lower spermine levels

In search of a more reliable and non-invasive method for prostate cancer diagnosis, Professor Gary Wong Ka-leung, Professor and Head of the Department of Chemistry at HKBU, and Professor Ng Chi-fai and Dr Peter Chiu Ka-fung, Professor and Associate Professor respectively of the Division of Urology in the Department of Surgery at CU Medicine, have collaborated since 2014 to identify a new biomarker to supplement the PSA test. They found that prostate cancer patients in general have lower levels of spermine, a biogenic molecule in their urine, which offers a clue for the diagnosis of prostate cancer.

To investigate the diagnostic performance of spermine, the research team recruited 905 patients between 2015 and 2019 to participate in a study. All of them had elevated PSA levels and/or abnormal DRE, with a prostate biopsy scheduled.

Score to estimate prostate cancer risk

Among the 905 patients, 600 of them who had PSA levels ranging from 4 to 20 ng/mL were included in the analysis. Their urine samples were collected before they underwent a biopsy procedure. The biopsy results showed that out of the 600 patients, 185 (30.8%) were diagnosed with prostate cancer.

At the same time, the urine samples of these 600 patients were also analysed. The results found that about 49% of the patients with spermine levels in the lowest quartile had prostate cancer, which was nearly triple the number of patients in the highest quartile (17%). The research team then used the urine spermine level figures and three other clinical parameters, namely DRE, PSA level and prostate volume, to develop the Spermine Risk Score, with the objective of offering a more accurate estimation of patients' prostate cancer risk.

The higher the Spermine Risk Score, the greater the patient's risk of developing prostate cancer. Only patients with Spermine Risk Scores higher than 6.2 will be advised to undergo the biopsy procedure. Based on Spermine Risk Scores calculated with data collected from the study, about 37% of the non-cancer patients could have avoided the biopsy procedure. Moreover, the negative predictive value of the Spermine Risk Score for significant prostate cancer is 95%, which means the chance of no significant cancer is 95% if the value of the Score is negative.

Promising approach for prostate cancer diagnosis

Dr Chiu concluded the findings by highlighting that, "This study confirms that urine spermine and the Spermine Risk Score are effective at identifying men at higher risk of prostate cancer and the test could help reduce the number of unnecessary biopsies."

"It is the ?rst prospective study to investigate the efficacy of urine spermine in prostate cancer detection. It successfully demonstrated that the Spermine Risk Score, developed based on patients' urine spermine levels and other clinical parameters, can serve as a novel and promising approach to address the limitations of the diagnostic methods currently in use," said Professor Wong.

"Although there are a number of blood and urine adjuncts to guide prostate biopsy decisions in patients with elevated PSA levels, urine spermine is a convenient non-invasive test that doesn't require another blood test or attentive DRE before specimen collection. Thus it minimises any potential complications associated with the procedures," said Professor Ng.

Tiny nanoparticles can be furnished with dyes and could be used for new imaging techniques, as chemists and physicists at Martin Luther University Halle-Wittenberg (MLU) show in a recent study. The researchers have also been the first to fully determine the particles' internal structure. Their results were published in the renowned journal Angewandte Chemie.

Single-chain nanoparticles (SCNPs) are an attractive material for chemical and biomedical applications. They are created from just a single chain of molecules that folds into a particle whose circumference measures three to five nanometres. "Because they are so small, they can travel everywhere in the human body and be used for a wide variety of purposes," says Professor Wolfgang Binder from the Institute of Chemistry at MLU. As it is a new area of research, some questions still remain unanswered. Up until now, for example, the inner structure of the particles had only been assumed, but not finally resolved.

After Binder and his team developed new single-chain nanoparticles that could be used in medicine, they wanted to know more about their structure. "We concluded that the nanoparticles we developed must have a special, internal structure," says Binder. To establish this, he contacted colleagues from the departments of chemistry and physics at MLU. Using a combination of electron spin resonance and fluorescence spectroscopy, the scientists were able to visualise the structure of an SCNP for the first time. "They form a kind of nano-pocket that can protect a dye or other molecules," explains Binder. Their findings are in line with previous assumptions about the possible spatial structure within such tiny particles.

The aim of Binder's research group is to develop nanoparticles for diagnostic testing. However, producing the nanoparticles is a complex task. "They have to be virtually invisible to the body," explains Justus Friedrich Hoffmann, a PhD student in Binder's research group. They cannot be destroyed by the body's immune system and they must also have the right internal binding sites so that a dye or another molecule can be stored and protected. In addition, they have to be water-soluble so that they can be transported via the bloodstream. "They often form large clumps, but we have now been able to produce individual particles," says Hoffmann. They used a chemical trick to condense the chain into the desired form.

The dye, which is incorporated during the manufacturing process, is to be used for so-called photoacoustic imaging. The procedure represents an alternative to computer tomography but without the dangerous radiation. It allows one to look several centimetres deep into tissue from outside the body. Normally the dye is quickly destroyed by the body, says Binder. The tiny nanoparticles protect the dye, which could be used, for example, in the visualisation of tumours which it would enter via blood vessels.

SCNPs can be used in a wide variety of other applications, too. For instance, they could be used as nanoreactors in which chemical reactions take place.

In the event of a pandemic, delayed reactions and a decentralized approach by the authorities at the start of a follow-up wave can lead to longer-lasting, more severe and more fatal consequences, researchers from the universities of Zurich and Toronto have found. The interdisciplinary team compared the Spanish flu of 1918 and 1919 in the Canton of Bern with the coronavirus pandemic of 2020.

The Spanish flu was the greatest demographic catastrophe in Switzerland's recent history, causing approximately 25,000 deaths in the country during 1918 and 1919. In the wake of the current coronavirus pandemic, there has been increased public and scientific interest in the events of that time. An interdisciplinary team of researchers in evolutionary medicine, history, geography and epidemiology from the universities of Zurich and Toronto has spent several years analyzing historical data on the spread of influenza-like illnesses during 1918 and 1919 in the Canton of Bern. The canton is ideally suited as a Swiss case study, because it is large and has a diverse landscape, it was hit particularly hard by the Spanish flu, and right at the start of the pandemic in July 1918 it introduced an obligation to report cases.

Public health measures effective in the first wave

The results of the new study show that the spread of Spanish flu differed depending on the region. In the first wave in July and August 1918, the Canton of Bern intervened relatively quickly, strongly and centrally, including by restricting gatherings and closing schools. "We see from the numbers that these measures - similar to today - were associated with a decrease in infection numbers," says co-first author Kaspar Staub of the Institute of Evolutionary Medicine at the University of Zurich. After the first wave had subsided, the canton lifted all measures entirely in September 1918, which led to a rapid resurgence of cases and the onset of a second wave after only a short time.

Delayed action at start of second wave was fatal

At the beginning of the second wave in October 1918, the Canton of Bern reacted hesitantly, unlike in the first wave. Fearing renewed economic consequences, the cantonal authorities left responsibility for new measures up to the individual municipalities for several weeks. "This hesitant and decentralized approach was fatal and contributed to the fact that the second wave became all the stronger and lasted longer," says co-first author Peter Jueni of the University of Toronto.

In addition, shortly after the peak of the second wave in November 2018, there was a national strike with demonstrations on social and labor issues and, most importantly, larger troop deployments. These mass gatherings, as well as a subsequent relaxation of the ban on gatherings when the number of cases was still far too high, were accompanied by a significant resurgence in infections. Ultimately, about 80 percent of the reported illnesses and deaths were attributable to the second wave.

History repeats itself in 2020

By comparing the weekly case counts of the Spanish flu and coronavirus, the researchers found that the second wave started in almost the same calendar week in both 1918 and 2020, and the official delayed response was similar. "While there are still considerable differences between the two pandemics, the steadily increasing parallels between 1918 and 2020 are remarkable," Staub says. The study also shows that empirical knowledge from past pandemics - for example, on the challenges and how to deal with follow-up waves - is available. "Since November 2020, deaths from Covid-19 have far exceeded those caused by cancer or cardiovascular disease and for around three months it has been the most common cause of death in Switzerland. In view of the high death rate during the second wave in comparison with other countries, and with the threat of a third wave due to virus mutations from England, South Africa and Brazil, lessons from the past could help the authorities and the public to rethink their response," adds Jueni.

Historical archive data with relevance for the present day

The study was based on records in the Bern State Archives of cases of influenza-like illness by municipality and region, as reported weekly by doctors to the cantonal authorities. "These records are a real treasure trove and a great example of how data that is more than 100 years old can be relevant today," Staub says. Back in 2015, the research team began transcribing the more than 9,000 medical reports with over 120,000 influenza cases from 473 Bernese municipalities between June 1918 and June 1919. They then analyzed the data using modern epidemiological methods and reconstructed the measures taken at cantonal level to prevent the spread of the pandemic to create an overall picture.

DALLAS - Feb. 8, 2021 - Pregnant women, who are at increased risk of preterm birth or pregnancy loss if they develop a severe case of COVID-19, need the best possible guidance on whether they should receive a COVID-19 vaccine, according to an article by two UT Southwestern obstetricians published today in JAMA. That guidance can take lessons from what is already known about other vaccines given during pregnancy.

In the Viewpoint article, Emily H. Adhikari, M.D., and Catherine Y. Spong, M.D., describe how the available safety and effectiveness data, basic science of mRNA vaccines, and long history of successful administering of other vaccines in pregnant women worldwide sets the backdrop for obstetricians to outline the potential benefits of COVID-19 prevention with their patients.

Vaccines against diseases such as influenza and whooping cough have shown to be lifesaving for women and newborns when administered to pregnant women. The pertussis vaccine reduced whooping cough, a potentially fatal respiratory illness in infants, by 85 percent compared with waiting until after pregnancy. Influenza vaccination during pregnancy reduced both mother and infant influenza illness by 20 and 30 percent, respectively. Although it is not known what level of infant protection might be provided against COVID-19 by maternal vaccination, Adhikari says the potential for protection exists.

In the article, Adhikari and Spong describe how pregnant and lactating women were excluded from clinical trials during the development of COVID-19 vaccines due to concerns over liability. As a result, guidance issued by professional organizations on the topic has been limited, leaving physicians responsible for discussing the pros and cons with patients based on benefits of other vaccines used during pregnancy, evidence from COVID-19 vaccine trials in nonpregnant patients, and basic vaccine science suggesting safety for the fetus.

"We still need granular data on safety in pregnancy and data that shows no adverse pregnancy outcomes," says Adhikari, an assistant professor of obstetrics and gynecology at UT Southwestern.

"But without that data, we still have to care for our patients. It's not something where we can just wait," says Spong, a UTSW professor of obstetrics and gynecology, who will speak about the issue in a virtual JAMA panel discussion today at 2 p.m. EST. astern Standard Time.

Both the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine have advocated for making COVID-19 vaccines available to pregnant and lactating women. The World Health Organization on Jan. 26 recommended against vaccinating pregnant women using the Moderna vaccine except in select circumstances, but three days later revised its statement to more permissive language, supporting offering the vaccine to pregnant women at high risk of exposure or with comorbidities in consultation with their health care provider. However, the change in language caused significant anxiety despite no concerning data that was made available.

"I am very supportive of any woman who decides to get the vaccine," Adhikari says. "I fully support that woman's choice. I understand if a woman decides she's not ready for the vaccine, but I also think it's an opportunity for education about vaccines in general."

Adhikari previously published a study of 3,374 pregnant women, including 252 who had contracted COVID-19 during pregnancy and 3,122 who tested negative. They found no increase in adverse pregnancy outcomes overall. But among the 5 percent of pregnant women who were hospitalized for COVID-19 respiratory illness, preterm births increased.

The Viewpoint article reviews how the major risks to a pregnancy are from maternal respiratory illness from COVID-19, and states that prevention is key.

"Women who are pregnant, who have severe respiratory distress, who need significant oxygen support - some intubated for months - have most risk to the pregnancy," says Spong, who holds the Gillette Professorship of Obstetrics and Gynecology.

For a wider context, the piece reviews how the messenger RNA vaccines proved safe and effective in preventing COVID-19, and that the same technology has been tested in trials for prevention or treatment of other diseases.

"We are doing ongoing data collection to demonstrate what we anticipate but have not shown - that this vaccine is safe in pregnant women, does not result in harm, and results in no difference in pregnancy outcomes," Adhikari says. "It's important for us to study that. That's going to help establish an evidence basis that will allow the public and clinicians to feel more comfortable with the vaccine."

Colorectal cancer screening rates jumped by more than 1,000 percent when researchers sent take-at-home tests to patients overdue for testing at a community health center that predominantly serves people of color. Instead of the oft-standard text message that simply reminds a patient that they are overdue for screening, researchers from the Perelman School of Medicine at the University of Pennsylvania made it the default to send a take-at-home test to the patient's home unless they opted out via a text message prompt. The research was published in the Journal of General Internal Medicine.

"Colorectal cancer screening rates remain limited in underserved populations, which includes those in the clinic we partnered with," Shivan Mehta, MD, associate chief innovation officer at Penn Medicine and an assistant professor of Medicine. "We saw that there is an opportunity to use text messaging and new insights from behavioral science to increase uptake."

Colorectal cancer can be especially deadly if it is not discovered early enough for curative treatment. Across the United States, regular screening rates are relatively low, particularly in community health centers, where less than half of eligible patients are up-to-date. One study, in particular, found that the number of deaths from colorectal cancer among Black people was 40 percent higher than in white people, and 100 percent higher than in Asian/Pacific Islanders.

One method consistently used to boost screenings is the fecal immunochemical test (FIT). These kits just require a stool sample from a patient -- which can be provided at home -- that are then returned to a laboratory by mail and analyzed for the trace blood associated with colorectal cancer. While a colonoscopy remains the gold standard because it is the most thorough check and only needs to be completed once every 10 years, FIT kits are much easier for patients to handle and likely to be completed, even though they only clear a patient for a year.

Looking to increase low completion rates, the researchers -- led by Mehta and the study's first author, Sarah Huf, MBBS, a former Commonwealth Fund Fellow at Penn and now an Honorary Clinical Lecturer at Imperial College London -- decided to focus on completing FIT kits. As such, they randomly split a group of more than 400 patients overdue for screenings into two equal arms: one that just received a single reminder text and another that received FIT kits unless patients sent a response to an introduction text to say that they didn't want them. Almost 90 percent of these patients were Black, and half were Medicaid beneficiaries.

From March to May 2018, these patients were enrolled to either receive the reminder text (the control group) or to receive the FIT kit pending an opt-out (the intervention group). The latter group also received up to three follow-up texts with messages based on proven behavioral science techniques to nudge them into returning the kits.

By the end of the period studied (12 weeks from when each patient received their first text message) a little more than 2 percent of the patients in the control group had completed a FIT kit or had a colonoscopy. But for the intervention arm of the study, nearly 20 percent had done the same.

When looking purely at FIT kit return rates, the intervention arm increased by more than 17 percentage points. In the control, it was less than two. And while screening rates did remain relatively low, the improvement showed great promise for the population served.

"It is important to note that this is a population at a community health center that may not routinely seek out medical care, especially preventive care, so there is a low baseline screening rate," Huf explained. "Future interventions may need to address issues such as reading comprehension and not having a stable place to live."

What was especially important for the type of clinic this study was performed in was the cost to apply it. For the 200 patients in the intervention arm, it only cost about $150.

"For these types of health clinics, minimizing cost is critical for sustainability since they have many competing health priorities for their patients," Mehta said.

Moving forward, Mehta and his fellow researchers plan to explore how best to offer the choice of colonoscopy or FIT kits to patients in the populations that receive care at this type of health center.

Multidisciplinary team of international experts suggests participants should receive a "substantial" amount, be paid ethically

Healthy people volunteering to be infected with SARS-CoV-2, in order to help scientists better understand how to tackle the virus, should receive payment - if it is determined that these studies are otherwise ethical to proceed.

Those are the findings of a new peer-reviewed study published in the American Journal of Bioethics, which has assessed the ethics of paying participants to take part in so-called 'Human Infection Challenge Studies' (HICS).

Over the past few months there has been vast media coverage and discussion about the first COVID-19 HICS in the world, planned to begin in the UK later this year. This type of study can be particularly valuable for testing vaccines and can speed up the development of new vaccines.

Using HICS for a disease that can be fatal and currently lacks a cure is ethically controversial. Part of that controversy has to do with whether participants should be paid for such a risky endeavor and how payment might affect their consent.

Among the advocates of pursuing COVID-19 challenge trials is the organization, 1Day Sooner.

1Day Sooner sponsored the report on which the new study is based, seeking an independent assessment of whether and how much people should get paid to take part in challenge trials.

The international research team from the UK, US, and Canada does not necessarily endorse the use of HICS for COVID-19. But if HICS proceed, their findings reflect that not only should participants be paid, but their payment should be "substantial".

The research team - including experts in bioethics, economics, science, medicine, and law, as well as two individuals expressing interest in participating in SARS-CoV-2 HICS - created a framework for scientists to follow in order to ethically assess payments for people taking part in HICS. They also looked at payment in similar studies, but noted the difficulty of finding out this information.

"Our work was spurred by concerns that payment for SARS-CoV-2 HICS might require a novel ethical framework, which we ultimately determined to be unfounded," states lead author Holly Fernandez Lynch, John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics at the Perelman School of Medicine, University of Pennsylvania.

"Payment for HICS participation should be treated like payment in other clinical studies involving healthy participants," she says.

"High offers of payment are sometimes met with scrutiny and concern, but it can be ethically appropriate to offer substantial payment for research participation and we have to consider that low payment also raises significant ethical concerns."

Professor Fernandez Lynch, who is a lawyer and bioethics expert, adds: "SARS-CoV-2 HICS should not be allowed to proceed in any setting in which there have not been adequate provisions made for compensating research-related harms, as well as other efforts to minimize risk and promote social value.

"Our hope going forward is that our analysis will serve both to ease concerns about payment in these studies, should they proceed, and to advance the broader project of ensuring ethical payment to participants in all clinical research."

The framework the team has developed is split into two-parts. The first focuses on three main motives for payment: 'reimbursement' (for out-of-pocket expenses), 'compensation' (which includes payment for time, burden, inconvenience of isolating, etc.), and 'incentive' (to broaden the range of individuals willing to consider participation). The second part considers appropriate compensation in the event any harm materializes - ranging from injury to death.

In developing the framework, the team paid special attention to public trust, acknowledging that "research payments could affect public trust in several ways". Ultimately, they conclude that "the best way to promote trust in HICS is by helping the public understand why this design can be both scientifically important and ethically acceptable".

"HICS can proceed only when strict research and ethical standards are satisfied," says co-author Thomas Darton, from the Department of Infection, Immunity and Cardiovascular Disease at The University of Sheffield.

Dr Darton is a HICS researcher, although he does not work with the SARS-CoV-2 virus.

He states: "If the risks associated with these studies are unreasonable in relation to their potential benefits, payment for participation cannot help achieve ethical acceptability. But if the research is otherwise ethical, it doesn't become unethical simply because payment is offered."

Another factor the team considered is whether COVID-19 HICS would be "uniquely risky" and how that should influence payment levels.
Ultimately, they concluded that "the ethical concerns about payment for these studies are the same as those for payment in all clinical research".

"Although certainly relevant to considerations regarding the ethical acceptability of HICS, including the importance of planning for research-related harm, heightened risks do not support adopting a novel framework for HICS payment as compared to other types of research," adds co-author Emily Largent, the Emanuel and Robert Hart Assistant Professor of Medical Ethics at the Perelman School of Medicine, University of Pennsylvania.

Limitations of the project include the team's perspectives being "limited to the Global North". They state, therefore, that additional considerations may be relevant when research is conducted elsewhere.
The team also declined to identify a payment amount or even a range that would be appropriate for HICS or SARS-CoV-2 HICS. "Stakeholders must take the final step between conceptual guidance and actual payment offers on their own," the paper concludes. "This means that there may be several different payment offers that could be justified, but the framework can help determine which offers are ethically appropriate," says Professor Fernandez Lynch.

Sudden cardiac arrest is more often fatal in people with COVID-19, a new study shows. Those responsible for the research see the results as a wake-up call for the public and care providers alike.

The survey now published in the
European Heart Journal is a register-based observation study. It covers all 3,026 cases of sudden cardiac arrest that were reported to the Swedish Registry for Cardiopulmonary Resuscitation in the period from 1 January to 20 July 2020 -- that is, both before and during the pandemic.

The Registry's statistics show that, in Sweden, there are 6,000 cases of sudden cardiac arrest annually in which the person is not admitted to hospital. Some 600 of these people survive. The corresponding figures for cardiac arrest during inpatient care are 2,500 cases and 900 survivors.

The study results indicate that mortality from sudden cardiac arrest is higher if the person has COVID-19, but that different patient groups show divergent differences in mortality rates.

During the study period, 1,946 cases of sudden cardiac arrest outside of hospitals were registered. In 10 percent of the cases in this group, the person had COVID-19, and the risk of a fatal outcome proved to be 3.4 times higher for these people than for the other group members.

Of the 1,080 cases of sudden cardiac arrest that took place in hospitals, COVID-19 was present in 16 percent. Among the patients with COVID-19, mortality was 2.3 times higher than for the others in this group.

The largest mortality difference was noted in the group of women who were already receiving inpatient care at the time of their cardiac arrest. In these women, ongoing COVID-19 infection was associated with nine times the risk of a fatal outcome during the initial months and a sevenfold risk from April onward.

The study, carried out by researchers at the Swedish Registry for Cardiopulmonary Resuscitation and the University of Gothenburg, received financial support from the Swedish Heart-Lung Foundation. This Foundation's prompt funding action was crucial for the implementation, emphasizes Araz Rawshani, registrar and researcher at the Faculty of Medicine, Sahlgrenska Academy, who also works at Sahlgrenska University Hospital.

"We hope our results can help to raise awareness of COVID-19 complications among the public, care providers, and decision-makers. That could improve care and mobilize resources for high-risk patients," he says.

Kristina Sparreljung is the Secretary-General of the Swedish Heart-Lung Foundation.

"We hope these results will help to enable more lives to be saved. This study is a direct result of the emergency grant provided by the Heart-Lung Foundation for research on COVID-19 connected with cardiopulmonary disease back in spring 2020," she says.

The survival rate for cardiac arrest has risen successively in recent years, but mortality remains high. Surviving a sudden cardiac arrest outside of hospital requires, pending arrival of an ambulance, immediate action in the form of cardiopulmonary resuscitation (CPR) and use of an automated external defibrillator (AED).

Around one in three working-age adults (29%) surveyed in France in July 2020 would refuse any COVID-19 vaccine.

Willingness to receive a COVID-19 vaccination depended upon its country of origin, effectiveness, rate of serious side effects, and site of vaccination.

Although attitudes may have changed since July 2020 with the approval of several vaccines and a second wave of COVID-19, the findings suggest that communicating the collective benefits of herd immunity reduced people's hesitancy about being vaccinated.

Nearly one in three working-age adults in France (29%) surveyed in July 2020 - when lockdown restrictions had been eased - were outright opposed to being vaccinated against the virus, according to new research published in The Lancet Public Health journal.

Researchers found that more than two-thirds of people (71%) could accept a vaccine depending on its characteristics, with their decision based largely on its effectiveness and country of origin.

Based on their findings, the authors recommend that mass vaccination strategies in France would be most successful if they use vaccines with robust evidence of high levels of effectiveness, especially vaccines produced in the USA or the European Union, and emphasise the collective benefits of herd immunity.

While the study was conducted in France - where vaccine skepticism, in general, is high -highlights potential hurdles that widespread distrust of new vaccines could pose to a vaccine rollout strategy to achieve herd immunity. The authors also note that the study was undertaken before the development of highly effective vaccines, which may have altered people's attitudes.

To date, three COVID-19 vaccines have been approved for use in the European Union. Reaching herd immunity - when upwards of 60% of a country's population is immune due to infection or vaccination - will likely involve the need for mass vaccination, as physical distancing measures aim to prevent people from becoming infected. However, recent evidence from opinion polls suggests that COVID-19 vaccine hesitancy is increasing worldwide. [1]

The authors of the new study surveyed a representative sample of 1,942 adults in France aged 18-64 years using a two-part online questionnaire. The first section sought background information such as participants' past vaccination behaviour and their risk of having a severe case of COVID-19.

In the second part, participants selected from a range of options relating to scenarios involving several hypothetical vaccines. These differed on four characteristics: efficacy (50%, 80%, 90%, or 100%); risk of serious side effects (1/10,000 or 1/100,000 vaccinated people); country of manufacturer (European Union, USA, or China); and site of vaccination (GP practice, local pharmacy, or mass vaccination centre).

Analysing survey responses using a behavioural model enabled researchers to distinguish between people who would accept a vaccination with certain characteristics (known as vaccine hesitancy) and those who would always refuse one - a distinction that is usually not explored using opinion poll data.

Dr Verity Watson, of the University of Aberdeen, UK, said: "We used a study design that allowed us to separate people into two groups: those who will accept vaccination depending on its characteristics, and those who would always refuse one. This information is important for designing mass vaccination campaigns because it shows how sensitive uptake is to the design of the campaign. Opinion polls are rarely able to separate people in this way."

The authors found that nearly one third (29%, 650/1,942) of the French working-age population would refuse any COVID-19 vaccine. Among participants who would not outright refuse a vaccine (71%, 1,382/1,942), hesitancy mainly depended upon the effectiveness of vaccines and the country where they were made.

Vaccine hesitancy was minimised - resulting in a 61% acceptance rate overall - in a scenario using a vaccine manufactured in the European Union that was 90% effective and had a low risk of serious side effects (1/100,000 people vaccinated). Vaccine hesitancy was at its highest - an acceptance rate of only 27% overall - in a scenario involving a Chinese-made vaccine with 50% effectiveness and a risk of serious side effects of 1/10,000.

Survey responses also indicated that a reduction in hesitancy for a vaccine with 90% efficacy (compared with a vaccine with 50% efficacy) was entirely offset if it was made in China rather than the European Union. The authors suggest that hesitancy based on country of origin may be due to perceived rushed development and safety concerns about vaccines made in countries outside the European Union.

The collective benefits of herd immunity should be emphasised as part of mass vaccination strategies, the authors suggest, as communicating these was associated with significantly less COVID-19 vaccine hesitancy.

Both hesitancy and outright refusal to be vaccinated were more likely among women, people with lower educational achievements, and those who had previously chosen not to receive other recommended vaccinations. People aged 18-24 years and 55-64 years were less likely to outright refuse or be hesitant about accepting a vaccine than people aged 25-54 years.

Dr Michaël Schwarzinger, of Bordeaux University Hospital, France, said: "Understanding the factors that determine whether or not working-age people will accept a COVID-19 vaccine is vital. Like France, the majority of the population in most high-income countries is made up of working-age people, which means that reaching herd immunity through a mass vaccination campaign can only be achieved if they are willing to take part."

"Our findings suggest that vaccine hesitancy, alongside other factors including limited vaccine supplies and the emergence of new COVID-19 strains, continues to pose major challenges to getting the pandemic under control. With evidence indicating that hesitancy to receive a COVID-19 vaccine is growing worldwide, studies such as ours are important for helping to inform the development and rollout of national vaccination strategies that people are likely to support." [2]

The authors acknowledge that the main limitation of the study is the timing of the survey. In July 2020, stringent physical-distancing measures had been lifted following the first wave of infections, and information on COVID-19 vaccination was limited. People's attitudes towards COVID-19 vaccination may have changed since then in response to a resurgence of the virus, reintroduced physical distancing measures, and the development of highly effective vaccines.

Writing in a linked Comment, Pierre Verger and Patrick Peretti-Watel from Observatoire Regional de la Santé Provence-Alpes-Côte d'Azur and Aix-Marseille University, France, respectively, suggest the results may be important for informing mass vaccination strategies, saying: " ...this study shows that most people are probably not absolutely for or against COVID-19 vaccines. Depending on their own profile and preferences, and on the characteristics of the vaccines available, vaccine-hesitant individuals might consider taking the vaccine or delay it to get another vaccine. Health authorities must anticipate these behaviours, especially since the characteristics that influence them could change over time."

Publication of this research coincides with two other new studies in The Lancet Public Health journal assessing different aspects of the pandemic in France. One sought to better understand common factors associated with in-hospital COVID-19 cases and deaths across the country, while the other investigated prevalence of the virus among homeless people in Paris.

DALLAS - Feb. 5, 2021 - The COVID-19 pandemic is having a detrimental impact on substance use, mental health, and weight-related health behaviors among people with obesity, according to a new study by researchers at UT Southwestern and the UTHealth School of Public Health.

The study, published in the journal Clinical Obesity, surveyed 589 patients with obesity who are enrolled in the UT Southwestern Weight Wellness Program, a multidisciplinary weight management and post-bariatric care clinic. Nearly half of the group reported using recreational drugs and alcohol, and 10 percent reported increased use since the start of the pandemic. Seventeen of the patients have tested positive for COVID-19.

Almost a quarter (24.3 percent) of the patients reported using opioids in the 30 days preceding the survey, 9.5 percent sedatives or tranquilizers, 3.6 percent marijuana, and 1 percent stimulants. Patients were surveyed from June 1, 2020, to Sept. 30, 2020, after COVID-19 stay-at-home orders had been lifted in North Texas.

"Many patients with obesity are also challenged by mental health conditions. Those who reported anxiety, depression, and trouble sleeping were two to four times more likely to increase their use of substances. For those who reported stress eating, there was a sixfold increase in substance use," says study author Jaime Almandoz, M.D., MBA, medical director of the Weight Wellness Program and assistant professor of internal medicine at UT Southwestern.

According to the Centers for Disease Control and Prevention, more than 42 percent of American adults are obese. Obesity-related health conditions include heart disease, stroke, Type 2 diabetes, and certain types of cancer that are some of the leading causes of preventable, premature death.

Nearly 70 percent of the patients reported that it was more difficult to achieve their weight loss goals during the pandemic, with about half spending less time on exercise. These findings were similar to another paper authored by Almandoz last spring, which was one of the first studies to show the impact of shelter-in-place orders on health behaviors in people with obesity.

"This study demonstrates that adults with obesity continued to engage in the same behaviors and struggled with mental health challenges, even after lockdown orders were lifted. We need to develop interventions targeting these vulnerable groups, such as telehealth options and outreach efforts," says senior author Sarah Messiah, Ph.D., M.P.H., an adjunct professor in the UTSW department of population and data sciences and a professor in the department of epidemiology, human genetics, and environmental sciences at the UTHealth School of Public Health.

The researchers noted that the patients surveyed were predominantly white, college-educated individuals with middle- to high-income levels. Thus, the survey results may not be generalizable to other populations, and may not accurately assess the burden of the pandemic on obesity-related health behaviors in lower socioeconomic status and/or ethnic minority populations disproportionately affected more by obesity and COVID-19. The survey participants were established weight management patients with health insurance - not representative of the average American challenged with obesity, in which less than 2 percent receive anti-obesity medications and fewer than 1 percent undergo bariatric surgery.

Cases of symptomatic COVID-19 were extremely low among children and staff at a network of YMCA summer camps held last year in North Carolina that took precautions like masking and physical distancing, with close to zero transmissions occurring at the camps, according to researchers at Duke Health, Weill Cornell Medicine and NewYork-Presbyterian.

In the camps' 2020 sessions, there were 19 cases of COVID-19 among 5,344 staff and 1,486 youth, only two of which were linked to possible on-site transmission at a group of YMCA of the Triangle camps, at a time when rates in North Carolina had hit their first peak, according to a study published Feb. 3 in Pediatrics.

"This is part of the growing body of evidence demonstrating that if precautions like masking, distancing and hand washing are taken, coronavirus transmission can be avoidable in congregate settings for children during times of high community incidence," said Dr. Sallie Permar, chair of the Department of Pediatrics at Weill Cornell Medicine, pediatrician-in-chief at NewYork-Presbyterian/Weill Cornell Medical Center and NewYork-Presbyterian Komansky Children's Hospital and a co-senior author of the study. Dr. Permar conducted the study at Duke when she was a member of its faculty; she joined Weill Cornell Medicine and NewYork-Presbyterian in December 2020.

The YMCA of the Triangle day camps are located at 31 sites across six counties in North Carolina, including the cities of Chapel Hill, Durham and Raleigh. The camps committed to opening for the summer of 2020 and were advised on programming and mitigation strategies by a group of pediatricians, including Dr. Permar, who at the time lived in the area."These results suggest that the benefit of in-person programming for supporting youth learning and mental health, particularly in vulnerable populations, outweighs the risk of viral spread," added Dr. Permar, who was recruited as the Nancy C. Paduano Professor of Pediatrics at Weill Cornell Medicine. "This is true not only in a school setting, but in a camp setting where children are engaging in activities like playing outside and at the gym and doing crafts."

The camps implemented daily temperature checks, physical distancing of at least 6 feet, masks at indoor activities and outdoors where participants couldn't remain distanced, frequent hand washing and sanitizing, and site cleaning. They also split campers into cohorts of 10 youth and one staff member and trained staff in COVID-19 protocols. An internal audit in June found over 95 percent compliance with the mask mandate.

To identify potential COVID-19 cases, the camps asked about exposures outside of camp before allowing campers on site. If the camps learned of an infection, they did contact tracing to identify campers or staff who were exposed. Ten youth and 9 staff, or 0.6 percent of 3,030 people at camp sites where the exposures occurred, had infections that were linked to transmission outside the camps. The other two cases, or .07 percent, were potentially connected to exposure at the camps. Widespread testing was not available, which meant asymptomatic cases were not detected. The most common symptoms were fever and cough, and no one was hospitalized.

There was no difference in rates of transmissions between camps held outdoors, camps held indoors and those that offered a hybrid. Campers were an average of 8.5 years old; 66 percent were white and 54 percent were male.

The rate of transmission in the general North Carolina population was significantly higher, at 200 new cases per 10,000 people each a day, or a 2 percent infection rate. In Durham, positive cases among those under age 18 rose from 9 percent to 17 percent of total cases in the population from May to August, indicating increased spread in that demographic.

The low transmission rate contrasted with an overnight camp in Georgia, where 44 percent of campers had symptomatic cases. The camp was reported to lack adherence to masking practices and physical distancing, and allowed indoor singing and shouting while people were unmasked. The camp also didn't require testing immediately prior to camp attendance.

Dr. Permar said YMCA of the Triangle camps should be credited for forming an "academic-community partnership" early on to involve medical personnel and scientists, and ensure precautions were taken.

"They worked hard to stay open and keep campers as safe as possible," Dr. Permar said, "knowing how important these camps are to kids whose parents are essential workers, work multiple jobs and don't have another option for childcare."

Common fungi, often present in the gut, teach the immune system how to respond to their more dangerous relatives, according to new research from scientists at Weill Cornell Medicine. Breakdowns in this process can leave people susceptible to deadly fungal infections.

The study, published Feb. 5 in Cell, reveals a new twist in the complex relationship between humans and their associated microbes, and points the way toward novel therapies that could help combat a rising tide of drug-resistant pathogens.

The new discovery stemmed from work on inflammatory bowel disease, which often causes patients to carry larger than normal populations of fungi in their guts. These patients often develop strong antibody responses against mannan, a molecule common to a wide range of fungal species. However, Dr. Iliyan Iliev, associate professor of immunology in medicine in the Division of Gastroenterology and Hepatology at Weill Cornell Medicine, noticed that healthy controls in these studies also had some level of anti-fungal antibodies. "There was no actual evidence for fungal infections in the healthy individuals that we examined, so we started thinking about the possible function of those antibodies," said Dr. Iliev, who is senior author on the study and a member of the Jill Roberts Institute for Research in Inflammatory Bowel Disease.

The team developed a platform that allowed them to determine which gut fungi are targeted by antibodies in the blood of individual patients. They detected a strong response against the yeast Candida albicans. Turning to experiments in mice, Dr. Iliev and Itai Doron, a Weill Cornell Medicine Graduate School of Medical Sciences doctoral candidate in the lab and lead author on the study, found that colonizing the animals' guts with Candida albicans caused them to develop antibodies against the fungus in their bloodstreams, even though they didn't develop blood-borne fungal infections. Instead, the animals' immune cells appeared to transport fungal antigens to the spleen, stimulating the production of circulating antibodies in the bloodstream. "Those fungi just educate that immune response," Dr. Iliev said.

In patients with suppressed immune systems, such as organ transplant recipients and some cancer patients, fungi in the gut can invade the bloodstream and cause life-threatening infections. Dr. Iliev and his colleagues mimicked this process by treating mice with immunosuppressive drugs. When a Candida species colonizes the gut of these mice, the fungus moves into the bloodstream, causing a fatal infection. Treating the mice with purified anti-fungal antibodies from donor animals protected the immunosuppressed mice from these infections. The same strategy worked against infection with either Candida albicans or the emerging pathogenic yeast Candida auris, which has become a major cause of fungal disease in immunosuppressed patients and the elderly in recent years.

Collaborating with researchers at INSERM in Paris, France, the Weill Cornell Medicine team also looked at serum from patients with mutations in a gene called CARD9. This mutation affects a critical adapter protein in the immune system, leaving the affected individuals susceptible to severe fungal infections. Dr. Iliev's team found that the serum of these patients lacked the anti-fungal antibodies normally seen in serum of patients without this mutation. Experiments in mice confirmed an essential and specific role for CARD9 in priming the production of anti-fungal antibodies.

Graphic depicting relationship between fungi in gut, antibody levels and CARD gene
Relationship between gut fungi, anti-fungal antibodies, CARD9 gene, and fungal immunity. Image courtesy of the Iliev lab.

The results suggest that normal intestinal fungi such as Candida albicans may function as a kind of intestinal vaccine against fungal infection in healthy people, by inducing the production of bloodborne antibodies that can target multiple species of potentially pathogenic fungi. When those fungi do enter the bloodstream, the antibodies bind them and target them for destruction by cells of the immune system. In patients with suppressed immunity, the anti-fungal antibodies may decline, leaving them vulnerable to fungal infection. New therapies that involve either stimulating the production of anti-fungal antibodies, or injecting such purified antibodies directly into patients' bloodstreams, could potentially help combat these increasingly common infections.

If that approach works, it would be a welcome development. "Many fungal infections in immunosuppressed patients and elderly patients are happening by translocation of pathogenic Candida species from the gastrointestinal tract, and the survival rates upon systemic spreading are alarmingly low," said Dr. Iliev.

The discovery of an "Achilles heel" in a type of gut bacteria that causes intestinal inflammation in patients with Crohn's disease may lead to more targeted therapies for the difficult to treat disease, according to Weill Cornell Medicine and NewYork-Presbyterian investigators.

In a study published Feb. 3 in Cell Host and Microbe, the investigators showed that patients with Crohn's disease have an overabundance of a type of gut bacteria called adherent-invasive Escherichia coli (AIEC), which promotes inflammation in the intestine. Their experiments revealed that a metabolite produced by the bacteria interacts with immune system cells in the lining of the intestine, triggering inflammation. Interfering with this process, by either reducing the bacteria's food supply or eliminating a key enzyme in the process relieved gut inflammation in a mouse model of Crohn's disease.

"The study reveals a therapeutically targetable weak point in the bacteria," said senior author Dr. Randy Longman, associate professor of medicine in the Division of Gastroenterology and Hepatology and the Director of the Jill Roberts Center for Inflammatory Bowel Disease at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center.

To find this "Achilles heel," Dr. Longman and his colleagues, including Drs. Ellen Scherl and Chun-Jun Guo at Weill Cornell Medicine and collaborators Dr. Gretchen Diehl at Memorial Sloan Kettering and Dr. Kenneth Simpson at Cornell's Ithaca campus, targeted a process the AIEC bacteria uses to convert a byproduct of sugar fermentation in the gut to grow. Specifically, the AIEC uses 1,2-propanediol, a byproduct of the breakdown of a type of sugar called fucose that is found in the lining of the intestines. When the AIEC converts 1,2-propanediol, it produces propionate, which the study showed interacts with a type of immune system cell called mononuclear phagocytes that are also found in the lining of the gut. This sets off a cascade of inflammation.

Next, the investigators genetically engineered AIEC bacteria to lack a key enzyme in this process called propanediol dehydratase. Without propanediol dehydratase, the bacteria do not set off a cascade of inflammation in a mouse model of Crohn's disease. Reducing the available supply of fucose in the animal's gut also reduced inflammation.

"Changing one metabolic pathway in one type of bacteria can have a big impact on intestinal inflammation," said the study's co-lead author Dr. Monica Viladomiu, a post-doctoral associate in medicine in the Division of Gastroenterology and Hepatology and in the Jill Roberts Institute for Research in Inflammatory Bowel Disease at Weill Cornell Medicine. Maeva Metz, a Weill Cornell Medicine Graduate School of Medical Sciences doctoral candidate in Dr. Longman's laboratory, is also co-lead author.

The discovery could lead to better treatments for Crohn's disease, a type of inflammatory bowel disease that affects more than 4 million people worldwide. Currently, patients with Crohn's disease are often treated with antibiotics, which can kill both beneficial and harmful bacteria causing unwanted side effects. But treatments that precisely target the inflammatory cascade discovered by Dr. Longman and colleagues might help reduce inflammation while preserving beneficial bacteria.

"If we can develop small molecule drugs that inhibit propanediol dehydratase or use dietary modifications to reduce the availability of fucose, we may be able to reduce intestinal inflammation in patients with Crohn's disease with fewer side effects," said Dr. Longman, who is also a member of the Jill Roberts Institute for Research in Inflammatory Bowel Disease.

One of the next steps for the team will be testing potential treatments. They also plan to study the potential role of an enzyme called fucosyltransferase 2 in protecting the gut against this inflammatory cascade. Dr. Longman explained that many patients with Crohn's disease have mutations in the gene that encodes this enzyme, rendering it nonfunctional.

"From a clinical perspective, that's interesting because it may help us stratify people for whom one intervention or another maybe more useful," Dr. Longman said.

UNIVERSITY PARK, Pa.-- When actor Tom Hanks announced his COVID-19 diagnosis on March 11, 2020, many Americans were still learning about the virus and its severity. According to new research, Hanks' announcement may have affected how some people understood the virus and their behavior toward its prevention.

The day after Hanks posted the news on social media, Jessica Gall Myrick, an associate professor in the Donald P. Bellisario College of Communications at Penn State, and Jessica Fitts Willoughby, associate professor at Washington State University, surveyed 682 people about their attitudes and behaviors toward COVID-19.

Just under 90% of the people surveyed had heard about Hanks' social media posts saying he contracted the virus, and approximately half of that group reported it changed their attitudes and behaviors. The results were published in the journal Health Communication.

"There is a growing body of research about how celebrity behavior and social media posts can affect public health," Myrick said. "This research was different in that we were able to launch our study really fast and collect survey data within a day of Hanks posting about his diagnosis."

According to the study, the people who had heard the news reported Hanks' diagnosis "highlighted the reality of COVID-19" and broadened their understanding of not only the severity of the situation, but also their susceptibility to the illness.

Nearly half of the participants who had heard the news when surveyed reported a range of emotional responses, according to the study. Responses included "surprise, fear, anger, sadness and hope." The respondents who reported making changes said Hanks' disclosure inspired them to seek more information and/or take stricter precautions.

"Celebrities can have a huge reach, often more so than typical scientists or doctors or the health department," Myrick said. "If they are encouraging positive health behavior change, then it can serve as a de facto public health intervention."

The half of respondents who heard the news and said Hanks' diagnosis did not change their thoughts or behaviors reported thinking the actor would recover from the illness. They also noted they were already aware of COVID-19 and its effects and did not think Hanks' announcement changed their outlook or intentions regarding the virus.

The researchers conducted a statistical analysis to see if and what characteristics could predict whether people's attitudes and behaviors changed after learning Hanks' diagnosis. The results indicated that people who identified with Hanks or said they knew him were more likely to change their thoughts or COVID-related behaviors due to the announcement.

"People who said they typically trust celebrities, friends, family, or Donald Trump for health information were more likely to say that Hanks' announcement led to positive behavior change," Myrick said. "This suggests that public health officials and advocates may want to use these types of celebrity announcements to help reach people who may be harder to reach. They don't rely as much on news or on scientists for health information."

Because the study was launched so quickly -- the day after the announcement -- the researchers were able to talk to some people who had not yet heard the news. Nearly 4% of respondents reported not hearing the news about Hanks' diagnosis. The researchers showed half of these participants the Facebook post where Hanks announced his COVID-19 diagnosis and the other half a non-COVID Hanks post.

The researchers found one notable difference among these groups. Those who read the COVID-19 post said they felt less capable of avoiding the virus compared to the group who read the non-COVID-related Facebook post. It could be that learning of Hanks' diagnosis, despite his wealth and resources, resulted in people thinking that if Hanks could not avoid COVID-19 then they may not be able to, either, said the researchers.

Myrick is affiliated with the Science Communication Program, a program in the Bellisario College that supports research in the science of science communication. Willoughby is an associate professor at the Edward R. Murrow College of Communication at Washington State, where she is a member of the strategic communications department.

An assessment published this week in the journal The Lancet HIV provides new insight about an initiative to integrate treatment of opioid use disorder along with HIV in Vietnam.

The study marks one of the first scientifically robust assessments of a new model of treating HIV in lower or middle income countries where injection drug use is a major cause of HIV infection. It also suggests the importance of building support for peer and community connections to tackle the opioid epidemic that continues to ravage the United States in the midst of the COVID-19 pandemic.

The study was led by scientists and physicians at Hanoi Medical University and Oregon Health & Science University.

"Our study suggests that countries that want to expand treatment for opioid use disorder with buprenorphine should consider interventions to support retention on treatment directed at family networks, peers and community health workers," said co-author Todd Korthuis, M.D., M.P.H., a leader in addiction medicine at OHSU and the study's principal investigator.

Korthuis, professor of medicine (general internal medicine and geriatrics) in the OHSU School of Medicine, became involved in initiating the program in Vietnam after serving as a Visiting Fulbright Scholar in 2012-13.

The new study is the first multisite randomized trial to compare HIV clinic-based buprenorphine therapy compared with simply referring HIV patients to methadone clinics for opioid use disorder treatment. The study examined outcomes for opioid use disorder and for HIV, and how well participants stuck with treatment.

Researchers found that ongoing support is critical.

"We understand that addiction is a brain disease, so people have relapses," senior author Le Minh Giang, M.D., Ph.D., chair of global health at Hanoi Medical University, said in a podcast hosted by The Lancet HIV. "In many cases, the patients left the opioid use disorder treatment and then relapsed into drug use. That's problematic for people who don't have good support from clinical staff."

Buprenorphine, also known as Suboxone, can be prescribed and used outside a specialty addiction clinic, whereas methadone must be closely monitored in part because of a higher risk of overdose in unsupervised settings. Between July of 2015 and February of 2018, a total of 281 people were enrolled in a pilot project to treat people with buprenorphine - a first in Vietnam.

"It's a more flexible treatment than methadone maintenance," Korthuis said. "You can integrate it into HIV clinics and, theoretically, in primary care clinics. Methadone has to be very carefully controlled in a specialty setting."

The new study found that access to buprenorphine is essential for countries aiming to expand access to treatment for opioid use disorder, especially among patients also being treated for HIV.

"One of the things I was impressed with, is the very tight social fabric in Vietnam," Korthuis said in the Lancet podcast. "It's impossible not to overstate the role of the family, the role of the neighborhood and the role of the community in every aspect of life, including health care."

In fact, Korthuis is already implementing a similar outreach model in several rural counties in Oregon through an initiative funded by the National Institutes of Health. Known as Oregon HIV/Hepatitis and Opioid Prevention and Engagement, or Oregon HOPE, the initiative relies on peers who have recovered from addiction to engage their neighbors in prevention and treatment services.

The program is currently active in several counties across southern and eastern Oregon.

"Community health workers who really know their neighborhoods are really good at engaging people in addiction treatment - and keeping them in treatment," Korthuis said.

Toronto - (February 4, 2021) The results of a Phase III randomized clinical trial have shown that when it comes to detecting clinically significant prostate cancer, Magnetic Resonance Imaging (MRI) with targeted biopsies (MRI-TBx) matches the current standard and brings a multitude of advantages. The PRostate Evaluation for Clinically Important Disease: MRI vs Standard Evaluation Procedures (PRECISE) study will help to make prostate cancer diagnosis more accurate and less invasive.

PRECISE included 453 participants at Canadian academic cancer centres who were either assigned to receive MRI imaging followed by MRI-TBx of suspicious areas (identified by MRI), or the current standard of care of a systematic 12-core transrectal ultrasound-guided (TRUS) biopsy (TRUS-Bx).

Key findings:

MRI with targeted biopsy found five per cent more clinically significant prostate cancers compared to those receiving systematic TRUS-Bx biopsies, conclusively demonstrating the method can at least match the performance of the current standard of care.

Compared to standard TRUS-Bx, the MRI-TBx were found to be better in identifying clinically significant cancers.

More than a third of patients in the MRI arm of the trial avoided biopsies altogether following negative imaging results. Those individuals received a follow-up MRI in two years' time.

Those who did have biopsies in the MRI arm had significantly fewer samples taken when compared to systematic TRUS-Bx, resulting in less pain and discomfort for patients. Moreover, the MRI arm had a decreased adverse event profile, including less hematuria (blood in the urine) and incontinence.

There is a major unmet need for a test that identifies clinically significant prostate cancer while avoiding overdiagnosing clinically insignificant cancers. Use of MRI reduced the unnecessary diagnosis of slow growing, clinically insignificant prostate cancers by 55 per cent.

These findings show decisively that MRI together with targeted biopsies offer patients a less invasive procedure, the chance to avoid a biopsy all together and can help avoid the over-treatment of clinically insignificant prostate cancer - all while detecting a higher rate of clinically significant cancers.

"My colleagues and I are thrilled about these results that show, without a doubt, that imaging and targeted biopsies are the future of prostate cancer diagnosis. We can catch more of the cancers we should be treating, avoid unnecessary treatment at the same time and improve the quality of life for our patients." says Dr. Laurence Klotz, Chair of Prostate Cancer Research at Sunnybrook Health Sciences Centre and lead author of the study. "We thank the study participants and our funders for their support and look forward to continuing our efforts to have this technology used more widely."

"The study’s findings have influenced Ontario Health-Cancer Care Ontario’s upcoming, updated Prostate MRI Guidelines, which will be released this year,” says Dr. Masoom Haider, co-lead of the study and Professor of Medical Imaging at the University of Toronto, and Clinician Scientist with the Ontario Institute for Cancer Research. “I am pleased to see our research produce results that will make a real difference in how prostate cancer is diagnosed and improve the lives of patients."

"I congratulate Dr. Klotz and the PRECISE team on this truly impactful research which will change clinical care and make a difference for men with prostate cancer," says Dr. Christine Williams, Deputy Director and Head, Clinical Translation at the Ontario Institute for Cancer Research. "It is a great example of how, with our partners, we are moving research innovations to the clinic to improve the lives of patients and treat cancer with improved precision."

"These practice-changing results will have a significant and positive impact on the roughly 64 Canadians who are diagnosed with prostate cancer every day. Thanks to the efforts of Dr. Klotz and his team, people will need to undergo fewer biopsies and for some of them, they will be spared from unnecessary biopsies and treatments altogether," says Dr. Stuart Edmonds, Executive Vice President, Mission, Research and Advocacy at the Canadian Cancer Society. "We are proud to support this research, which will help people with prostate cancer live longer, fuller lives."

"At Movember, we are honoured to play a role in funding cutting-edge research like the PRECISE study, ultimately helping to provide more positive outcomes for men living with or beyond a prostate cancer diagnosis," says Todd Minerson, Country Director for Movember Canada.