Body

In the COVID-19 special session taking place at the online Annual Meeting of the European Association for the Study of Diabetes (EASD), Prof. Juliana Chan, (The Chinese University of Hong Kong and Prince of Wales Hospital, Shatin, Hong Kong, China) will present a new review of the evidence on the devastating impact COVID-19 is having on people with diabetes.

"Major risk factors for mortality include advanced age and chronic conditions, notably obesity, diabetes, hypertension, heart and kidney disease as well as social deprivation, minority ethnic groups and those with poor access to care. These frequent coexisting conditions highlight the complexity of COVID-19," explains Professor Chan.

In a recent report from The Lancet Diabetes & Endocrinology*, in a UK population-based survey of over 60 million people registered with the primary care system, 0.4% had type 1 diabetes and 4.6% had type 2 diabetes. Yet amongst the more than 24,000 deaths due to COVID-19, 30% occurred in people with diabetes. After adjusting for multiple risk factors including social deprivation, ethnicity and other chronic conditions, people with type 1 diabetes had an almost 3-fold (2.86 times) risk of death, and those with type 2 diabetes, an almost 2 times (1.8) higher risk of death due to COVID-19 versus those without diabetes.

Despite the short duration of the pandemic, still less than one year, a search term of 'COVID-19 and diabetes' yielded over 1800 publications in PubMed. "Many of these reports indicated close relationships between high blood glucose levels and poor outcomes including mechanical ventilation, admissions to the intensive care unit and death in patients with COVID-19," explains Prof Chan.

Glucose is a fuel and its effective use depends on adequate oxygen supply and insulin action to promote glucose entry into the cells to maintain bodily functions and survival. Diabetes is due to absolute or relative insulin insufficiency. People with poorly controlled diabetes have low grade inflammation, poor circulation and body defences. During acute stress such as COVID-19, these interlinking systems can destabilise resulting in uncontrolled blood glucose and multi-organ failure. In a consensus statement published in The Lancet Diabetes & Endocrinology, international experts call for optimisation of outpatient and in-patient care including appropriate use of insulin to control blood glucose and use of organ-protective drugs to improve the outcomes of these high risk patients.

Prof Chan says: "SARS-CoV-2 may damage pancreatic beta-cells, the only insulin-secreting cells. As such, COVID-19 may precipitate diabetes in people with risk factors such as those with obesity, low socioeconomic status and psychosocial stress."

The use of social distancing and restricted travelling have controlled the outbreak to some extent but also resulted in economic hardships and emotional distress. These can have effects on personal health, societal productivity and access to routine care. She adds: "On a more positive note, the COVID-19 crisis has raised public awareness about the plight of these vulnerable people and motivated development of new strategies such as telehealth aimed at providing preventive care and ongoing support to reduce the impacts of acute and chronic complications in these high risk individuals."

Prof Chan concludes: "Diabetes and COVD-19 are silent epidemics with devastating consequences, if not diagnosed or controlled. These global epidemics have strong environmental, behavioural and system determinants. The COVID-19-diabetes story highlights the huge burden of diabetes which affects 460 million people worldwide, mainly coming from developing countries with unprepared healthcare systems. This dual epidemic also illustrates how widespread social and care disparity can affect the global healthcare and economic systems during acute crisis. In this interconnecting world, there is an urgent need to improve our ecosystem, promote health literacy and reform our health and social systems to protect the health and humanity of people with vulnerable conditions such as diabetes."

A survey of more than 7,000 patients with type 1 diabetes from 89 countries, presented at this year's online Annual Meeting of the European Association for the Study of Diabetes (EASD) shows that three quarters of patients who have adapted to telemedicine appointments would consider continung the use of online or telephone appointments with their doctors, as has been happening during the COVID-19 pandemic, after the pandemic ends.
The study is by Dr Sam Scott and Prof Christoph Stettler, University of Bern, Switzerland, and colleagues, and will be published in the journal Endocrinology, Diabetes & Metabolism.

The COVID-19 pandemic has forced rapid reconsideration as to the way in which health care is delivered. One potential means to provide care while avoiding unnecessary person-to-person contact is to offer remote services (telemedicine).

Type 1 diabetes may be particularly well suited to telemedicine, as consultations are mostly based around a review of glucose data and conversations about therapy. The increasing use of continuous glucose monitoring (CGM), insulin pumps and smart insulin pens, alongside cloud/screen-based data sharing and greater access to webcams, can make this particularly useful, as both the healthcare provider and patient can simultaneously view the data without being together physically.

This study aimed to gather real-time information on the use and perception of telemedicine in people living with type 1 diabetes, and assess the challenges, such as restricted access to health care and/or medical supplies at the beginning of the COVID-19 pandemic.

There were 7477 survey responses from individuals in 89 countries. Globally, 30% reported that the pandemic had affected their healthcare access due to cancelled physical appointments with their healthcare providers. A third (32%) reported no fundamental change in their medical follow-up during this period, and 9% said that no personal contact was established with their doctors over the duration of the study.

More than a quarter (28%) received remote care through telephone (72%) or video-calls (28%). Of these, 86% found remote appointments useful and 75% plan to have remote appointments in the future. Glucose control, indicated by glycated haemoglobin HbA1c, was positively associated with positive perception of telemedicine. In males, 45% of respondents with an HbA1c > 9% (considered poor control) rated telemedicine not useful compared to those with lower HbA1c, while 20% of females with an HbA1c > 9% rated it not useful compared to those with lower HbA1c.

Dr Scott explains: "Due to the rapidly changing situation at the start of the pandemic, there was tremendous uncertainty, with almost no information on how people with type 1 diabetes would be affected. At the time, it was unknown whether people would experience difficulties gaining access to supplies such as insulin or what the impact of missing appointments with their endocrinologist would mean."

He concludes: "The COVID-19 pandemic poses unique challenges to diabetes care. The results from this real-time worldwide survey demonstrate that a large number of people living with type 1 diabetes have rapidly adopted telemedicine or plan to in the near future and that this has generally been perceived positively. Interestingly, age and level of education do not appear to influence peoples' perceptions of telemedicine so far, whereas poor glucose control seems to negatively affect the perception on usefulness of telemedicine, particularly in males. Beyond the pandemic, telemedicine may offer an alternative means to improve efficiency and cost effectiveness of care for people with diabetes."

New research presented at this year's annual meeting of the European Association for the Study of Diabetes (EASD) shows that among people with type 1 diabetes who stopped working in the COVID-19 lockdown, blood sugar levels improved during the first week of lockdown despite having reduced opportunities for exercise and heightened psychological stress. The study was undertaken by Dr Federico Boscari and colleagues at the Department of Medicine, University of Padova, Italy.

During lockdown, outpatient clinics were closed, while hospitals worked to deal with thousands of patients infected with SARS-CoV-2. As a result, the combination of the virus and the measures imposed to control it not only caused morbidity and mortality among infected patients, but also imposed a heavy burden on societal and population health. The impact of this is expected to be greatest among individuals with chronic diseases such as diabetes, due to outpatient clinics and services being scaled back or closed altogether.

Flash glucose monitoring (FGM) devices, widely used by individuals with T1D, have enabled healthcare professionals (HCPs) to maintain interaction with their patients throughout the lockdown, by providing real-time blood glucose level data to the clinic.

The team used data from 33 individuals with T1D who were selected using the following criteria: they attended the diabetes outpatient clinic of the University Hospital of Padova; lived in the area; had used the FreeStyle Libre FGM system (Abbott Diabetes Care, Rome, Italy) to monitor their glucose levels for at least 3 months; were sharing sensor data with the clinic, and had returned >90% of readings.

The time periods upon which the study was based were defined as follows: the 3 months before the start of measures to control the outbreak; the week immediately prior to the introduction of controls; the 14 days between the start of restrictions and full lockdown, and the first week of lockdown when everyone apart from essential workers was requested to 'stay at home'.

Patients were divided into 2 groups based on whether they stopped working during lockdown or continued to work due to being classed as an essential worker (such as those in healthcare or food supply), with the latter serving as the control group. The 20 who stopped working had an average age of 37 years, 60% were male, and had been living with diabetes for 15 years on average. The 13 who continued to work had an average age of 45 years, 53.8% were male, and their average diabetes duration was 5 years. Eight members of this second group were on insulin pump therapy which continuously supplies insulin and largely replaces the need for the patient to inject themselves multiple times per day.

The authors say: "In the 20 patients who stopped working, overall glycaemic control improved during the first 7 days of lockdown as compared to the weeks before SARS-CoV-2 spread."

Average blood glucose concentration decreased in these individuals from 177mg/dL in the week before lockdown to 160mg/dL during lockdown itself; the proportion of time spent 'within the safe range' increased from 54.4% to 65.2%; and time spent in hyperglycaemia (glucose level too high) decreased from 42.3% to 31.6%, while there was no significant change in time spent in hypoglycaemia (glucose level too low).

In contrast, the 13 patients who continued working during lockdown exhibited no improvement or deterioration in any of the measures of glycaemic control compared with before lockdown.

The researchers speculate that the improvement in patients who stopped working occurred due to them having more time to focus on diabetes control and a more regular lifestyle, including the timing and composition of meals. They also suggest: "In addition, the knowledge that diabetes worsens the outcomes of COVID-19 may have improved patients' awareness and compliance to diabetes management."

They acknowledge that participants had relatively good blood sugar control to begin with, so it is unclear whether the same results would apply to patients with worse glucose control or less frequent sensor scans. Lastly, only one week of lockdown was studied due to subsequent weeks introducing potential bias from patients having been contacted by the clinic with advice on diabetes management. Despite this, the data collected after this first week of lockdown suggests that this better blood sugar control continued in the patients who stopped working. Furthermore, other research from Spain backs the findings of this study. (see link below)

The authors conclude: "Despite the psychological stress and very limited opportunities for exercise, the study found that glucose control was significantly improved in patients with T1D who stayed at home during the first week of the COVID-19-induced lockdown in Italy. This observation suggests that slowing down routine activities can have beneficial effects on T1D control in the short term. However, the long-term effects of lockdown and the factors that affect glucose control in this particular situation deserve future investigation."

A team of researchers from Charité - Universitätsmedizin Berlin and the Deutsches Rheuma-Forschungszentrum (DRFZ) Berlin, a Leibniz Institute, have successfully treated two patients with the autoimmune disease systemic lupus erythematosus. Using daratumumab, a monoclonal antibody which targets specific immune cells known as plasma cells, the researchers were able to modulate the abnormal immunological memory processes found in these patients. Treatment induced sustainable clinical responses and resulted in a reduction in systemic inflammation. The results of this research have been published in the New England Journal of Medicine*.

The body's immunological memory enables the immune system to respond more rapidly and effectively to pathogens that have been encountered before. This immune response is mediated by both memory T lymphocytes and antibodies, which are produced by cells known as 'plasma cells'. Mature memory plasma cells reside in special niches in the bone marrow and are able to produce large amounts of antibodies for decades or even life-time. In autoimmune diseases, the immune system mistakes part of the body as foreign and considers it a danger. In a process that is assisted by the body's immunological memory, the immune system mounts a response using 'autoantibodies'. Systemic lupus erythematosus (SLE) is a prototypical autoimmune disease in which antibodies are produced against components of the body's cellular nuclei. This autoimmune response is associated with inflammation that may affect the skin, joints, or internal organ systems such as the kidneys, heart or central nervous system. Traditionally, treatments have relied on the long-term suppression of the immune response. Until now, however, they have not been targeted at mature memory plasma cells.

For the first time - and working alongside colleagues from the DRFZ (led by Prof. Dr. Andreas Radbruch) - Charité researchers, led by Dr. Tobias Alexander, have studied the effectiveness and tolerability of a plasma cell-specific treatment in two lupus patients who failed to respond to conventional therapies. "In a certain proportion of patients, the disease cannot be controlled using currently available treatments. As a result, there is a desperate need for novel and targeted treatment approaches," explains study lead Dr. Alexander, who is Head of Rheumatology Outpatient Services at Charité's Department of Rheumatology and Clinical Immunology and also conducts research at the DRFZ.

The researchers focused their efforts on the monoclonal anti-CD38 antibody daratumumab, which has been used for years to successfully treat patients with plasma cell cancer. The role of plasma cells in autoimmune diseases has been a major focus of the work conducted by the research group led by Dr. Alexander and his co-author, Prof. Dr. Falk Hiepe. "CD38 surface protein is considered a classic plasma cell marker. However, our preliminary investigations have shown that, in patients with lupus, increased levels of this marker can also be detected in other active immune cells such as memory T lymphocytes, as well as in the blood and urine," explains Dr. Alexander. This makes CD38 an ideal target for treatment, which aims to eliminate the pathologically altered immune cells.

The recipients of this new treatment were two female patients with life-threatening lupus, whose symptoms included inflammation of the heart and kidneys and antibody-induced anemia. Weekly administrations of daratumumab over four weeks resulted in a rapid and significant improvement in symptoms, which remained stable for several months. The patients also showed a marked decline in serum autoantibody levels. Using state-of-the-art immunological techniques - including single-cell sequencing - the researchers were furthermore able to show that daratumumab has a positive effect on active T lymphocytes, which are thought to play an important role in disease development. No relevant side effects were recorded. Although testing revealed a decline in protective antibodies in the blood, this was not associated with increased susceptibility to infections.

"The promising results seen in SLE may be transferable to other autoimmune diseases in which autoantibodies play a role," says first author Lennard Ostendorf, a doctoral student at the DRFZ. The next step, however, will be to test the safety and efficacy of daratumumab in a larger group of lupus patients. For this, the researchers are planning to conduct a pilot clinical study, which will be led by Dr. Alexander and conducted at Charité.

New research presented at this week's ESCMID Conference on Coronavirus Disease (ECCVID, held online from 23-25 September) shows that having a lower level of zinc in the blood is associated with a poorer outcome in patients with COVID-19. The study is by Dr Roberto Güerri-Fernández, Hospital Del Mar, Barcelona, Spain, and colleagues.

Increased intracellular zinc concentrations efficiently impair replication/reproduction of a number of viruses. However, the effect of plasma zinc levels on SARS-COV-2 is not yet understood. In this study, the authors explored whether plasma zinc levels at admission are associated with disease outcome in COVID-19 patients.

The authors did a retrospective analysis of symptomatic admitted patients to a tertiary university hospital in Barcelona, Spain over the period from 15th March 2020 to 30th April 2020. Data on demography, pre-existing chronic conditions, laboratory results and treatment were collected. Clinical severity of COVID-19 was assessed at admission. Fasting plasma zinc levels were measured routinely at admission (baseline) in all patients admitted to the COVID-19 Unit. Computer modelling and statistical analyses were used the assess the impact of zinc on mortality.

During this period of study 611 patients were admitted. The mean age was 63 years, and 332 patients were male (55%). During this period total mortality was 87 patients (14%).

This study includes 249 of these patients (of whom 21 [8%]) died. The authors say the 249 patients in this analysis are representative of the whole cohort of 611, and data collection and analysis for the other patients is ongoing - but the continuation of the study has been made difficult by the arrival of the second wave of SARS-CoV-2 in Spain.

Mean baseline zinc levels among the 249 patients were 61 mcg/dl. Among those who died, the zinc levels at baseline were significantly lower at 43mcg/dl vs 63.1mcg/dl in survivors. Higher zinc levels were associated with lower maximum levels of interleukin-6 (proteins that indicate systemic inflammation) during the period of active infection.

After adjusting by age, sex, severity and receiving hydroxychloroquine, statistical analysis showed each unit increase of plasma zinc at admission to hospital was associated with a 7% reduced risk of in-hospital mortality. Having a plasma zinc level lower than 50mcg/dl at admission was associated with a 2.3 times increased risk of in-hospital death compared with those patients with a plasma zinc level of 50mcg/dl or higher.

The authors conclude: "Lower zinc levels at admission correlate with higher inflammation in the course of infection and poorer outcome. Plasma zinc levels at admission are associated with mortality in COVID-19 in our study. Further studies are needed to assess the therapeutic impact of this association."

Oral pre-exposure prophylaxis (PrEP) is a highly effective method of reducing risk for HIV, yet use of PrEP is uniformly low, especially among women. As a result, researchers have developed long-acting injectable (LAI) versions of PrEP, one version of which was recently shown to be superior to oral PrEP in Phase 3 trials. A new study among women at high risk for HIV explored their hesitancy to use PrEP overall, as well as their interest in and willingness to use LAI PrEP. While one-third of the women interviewed would not consider PrEP regardless of its formulation, when asked to choose, the majority (55%) would prefer LAI PrEP over oral PrEP.

Researchers at Columbia University Mailman School of Public Health led the research, as part of Women's Interagency HIV Study (WIHS), the largest national prospective cohort study of women living with HIV and at risk for HIV infection in the U.S. Their analysis of in-depth interviews with 30 HIV-negative women, nearly all who are women of color, appears in the journal AIDS and Behavior.

Despite PrEP's increasing availability and inclusion in many state Medicaid formularies, just over half of the women interviewed had heard of PrEP. These women, whose median age was 51, shared a near uniform view that LAI PrEP was a useful option for others, but that it was not relevant for their lives. This was due to low levels of perceived HIV risk, primarily due to being in monogamous partnerships. However, previous research suggests a potential disconnect between perceived HIV risk and actual HIV risk; the only group of women for whom HIV incidence is not decreasing is 55 and over. An earlier study of HIV-negative women in WIHS found that 7 percent had a partner living with HIV, 38 percent had a new partner in the past six months, 19 percent reported consistent condom use, and 18 percent reported using cocaine or heroin--all risk factors for HIV.

Women pointed a number of barriers to using LAI PrEP, including their fear of new--and perceived untested--injectable products, injection location (buttocks) and related side effects (soreness); the need for more frequent doctors' visits (LAI PrEP injections require clinic visits every two months vs. every three to six months for pills); and medical mistrust. The researchers note that medical mistrust might also be particularly salient for women of color given the U.S.' history of forced sterilization campaigns that often used injections.

Reported benefits of LAI PrEP included beliefs that shots were more effective than pills, and convenience and confidentiality related to injections. The researchers speculate that LAI PrEP may provide a safeguard for women whose partners refuse condoms or for those who believe their partners may be unfaithful, while providing confidentiality in ways that minimize the fear of retaliation--providing women with more autonomy over their bodies and control of their health.

Women living with HIV comprise nearly one-quarter of all persons living with HIV in the U.S. Although HIV incidence has declined among women overall since 2010, HIV incidence has not decreased among women 55 and older. In addition, racial and ethnic disparities remain stark: in 2017, Black women constituted 59 percent of new HIV diagnoses among women despite being just 13 percent of the female population. Other research has shown that older adult women do not see themselves at risk for HIV, and often lack knowledge about HIV risk. However, HIV prevention programs rarely target women over 50 and healthcare providers rarely communicate with this demographic about sexual risk.

"Women of color in the U.S. are at disproportionate risk of HIV acquisition, and we must explore how prevention measures can be scaled up and deployed in ways that can be easily incorporated in their daily lives," said first author Morgan M. Philbin, PhD, assistant professor of sociomedical sciences at Columbia Mailman School. "Continued efforts must be made to provide information about PrEP in an appropriate and non-stigmatizing way to all women, and also to address all types of barriers that challenge women's ability to access and to use PrEP."

One of the major symptoms of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is post-exertional malaise (PEM), the worsening of symptoms after physical or mental activities. Using their own words and experiences, people with ME/CFS described how debilitating PEM can be in a study in Frontiers in Neurology. This is the first publication to come out of the National Institutes of Health's intramural post-infectious ME/CFS study.

"Post-exertional malaise following normal activities is unique to ME/CFS and we do not understand the biology underlying this severe and harmful feature of the disease," said Walter Koroshetz, M.D., director of NIH's National Institute of Neurological Disorders and Stroke (NINDS). "In-depth conversations with people who experienced post-exertional malaise and listening to them describe their individual experiences can provide a perspective not achieved through surveys. This study provides a window into just how much post-exertional malaise can affect a person's quality of life."

Researchers led by Avindra Nath, M.D., clinical director of NINDS, recruited 43 individuals with ME/CFS to participate in nine focus groups discussing their experiences with post-exertional malaise, including activities that led to it, how long it lasted, and techniques they used to help decrease their symptoms. Five out of the nine focus groups included participants who experienced PEM following a cardiopulmonary exercise test (CPET), which can measure how the body reacts to exercise and is often conducted using a stationary bike.

The focus groups were part of a larger study taking place at the NIH Clinical Center designed to take a comprehensive look at ME/CFS preceded by an infection. The goal of the larger study is to identify clinical and biological aspects of ME/CFS that may improve understanding of causes and how the disease changes over time. Dr. Nath and his colleagues will also examine the progression of PEM in study participants who undergo a CPET. The researchers included CPET experience in the PEM focus groups to assist in the design of the exercise challenge of the NIH ME/CFS study.

ME/CFS is a debilitating, chronic disease that may affect between 836,000 and 2.5 million people in the United States. In addition to PEM, people with ME/CFS will often experience pain, cognitive difficulties, and severe fatigue that does not improve with rest. The disease can affect all parts of the body including the immune, metabolic, cardiovascular, and neurological systems. There is no treatment for ME/CFS.

Qualitative analysis from the focus groups revealed that although the participants used a wide range of phrases to describe their experiences, many of their PEM symptoms fell into three core categories: exhaustion, cognitive difficulties, and neuromuscular complaints. Additional PEM symptoms included headaches, pain, nausea, sore throat, and sensitivity to light and sound. The onset of PEM is generally between 24 and 48 hours after exertion and can last from 24 hours to several weeks.

Almost everyone in the study indicated that complete rest, often in a dark and quiet room, was required to reduce the symptoms.

In addition, many participants described efforts to plan ahead and limit activities to avoid PEM, while also acknowledging that it can occur unexpectedly.

"It was quite striking to hear the extent to which PEM can affect their quality of life," said Barbara Stussman, statistician at the NIH's National Center for Complementary and Integrative Health and lead author of the study. "The widespread body symptoms, the unpredictability of PEM, and the sometimes-lengthy recovery greatly hindered individuals' ability to live a 'normal' life."

The study also identified, for the first time, differences between PEM caused by daily activities, such as grocery shopping or going to a doctor's appointment, and PEM caused by the lab test CPET. The results suggest that the overall symptoms were similar, but PEM caused by the exercise test came on faster and lasted longer.

Additional research is required to learn more about the causes of PEM in people with ME/CFS. Future studies may identify sub-types of PEM, which may help guide targeted treatments.

ROCHESTER, Minn. -- A new study published in the Journal of the National Cancer Institute is the first to examine the opinions and experiences of clinical oncologists working at a major medical center on the Federal Right to Try (RTT) law.

Enacted in 2018, the Federal RTT law was created as a new and parallel pathway to the Food and Drug Administration's (FDA) Expanded Access Programs (EAPs). The federal RTT law permits patients to request experimental medicine outside of clinical trials for cancer patients and patients with other conditions, but differs from EAPs since it requires no FDA review or ethics approval from an Institutional Review Board.

The study team undertook 21 interviews with oncologists at Mayo Clinic locations in Florida, Minnesota and Arizona who had experience obtaining experimental medicines for patients outside of clinical trials via the FDA's EAPs. "We purposely chose oncologists with experience in clinical trials and EAPs because they were likely to know about RTT and may have had experience with RTT, " says the study's lead author, Zubin Master, Ph.D., a Biomedical Ethicist at Mayo Clinic. Dr. Master says oncology and hematology are two fields with some of the highest number of EAP requests.

EAPs are preapproval pathways that permit oncologists to request access to unapproved and experimental drugs from companies for their patients when the patient is ineligible to participate in a traditional clinical trial.

Dr. Master says that despite all of the study participants having some experience with EAPs, most had limited familiarity and experience with RTT. And several participants reported being confused about the provisions of the RTT law, including whether patients had a right to investigational drugs and whether a drug company had an obligation to provide them.

"The federal RTT law does not obligate pharmaceutical companies to provide experimental drugs to patients and patients do not have any additional rights to access experimental drugs," says Dr. Master. "In this sense, RTT is similar to EAPs because in both cases, physicians have to request experimental drugs for patients, but companies do not have to provide them." Moreover, Dr. Master says "other studies have shown that FDA grants over 99 percent of EAP requests and gives physicians advice on dosage and monitoring."

After capturing the initial views of oncologists, the study team provided information about the federal RTT law to capture the opinions of participants. The study showed that the oncologists interviewed were interested in reducing their regulatory burden, but expressed concerns about RTT including:

Concerns about patient safety, limited oversight, and an unclear mechanism for accessing experimental therapeutics

No provision to collect data on patients who were given an investigational drug

Potentially heightening patient expectations.

Dr. Master and his colleagues observed that only a handful of oncologists had experience discussing RTT with their patients and none of them obtained the drugs from companies. "Oncologists identified the need to have a nimbler regulatory framework for accessing drugs for patients outside of clinical trials, a desire for more education, and the need for administrative support on the preapproval process," said Dr. Master.

"Our study shows that oncologists at a major cancer center, most of whom were engaged in clinical research and all of whom had experience with EAPs, were less informed about RTT, says Dr. Master. The study concludes that oncologists need to be better informed about RTT and other preapproval pathways in order to provide the best care for oncology patients.

Left or right. Among other uses, these terms can generally identify most Americans' political beliefs -- liberal or conservative, Democrat or Republican. When these views are at the extreme ends of the political spectrum, they are known as political polarization. With the gap between these political ideologies in American politics growing wider, experts argue that the gap between both sides is threatening the health of America's democratic system of government.

However, up to this point little has been done in proposing a solution to help decrease this political animosity. Now, communication experts at the University of Missouri have recently developed a narrative writing exercise designed to encourage people to reduce their political polarization.

"When people become politically polarized, they are unable to understand the people who are politically different from them, so they tend to make up reasons for why they are in disagreement," said Ben R. Warner, an associate professor of communication at MU's College of Arts and Science and co-director of MU's Political Communication Institute. "It's rooted in a belief that similarly minded people are motivated by benevolence, while those from the other group are motivated by malevolence. When that happens, the stakes of winning and losing in politics are too high, and it becomes impossible for people to cooperate with others who are politically opposite. This belief system can also lead to negative thoughts about democracy as a viable form of government."

For Warner, the encouragement to reduce political polarization needs to happen early on in life.

"For most people, their political socialization occurs sometime between the ages of 16 - 22," Warner said. "So, this is the prime time to reach young people as their long-term political attitudes are forming."

Warner's self-described "obsession" with politics began early. After he joined his high school's debate team, his interest in the study of communication began and continued into college. In graduate school, his debate team coaches encouraged him to study political communication, since the team was based in the communication department. This occurred during the rise of the internet in the early 2000s, and Warner, while optimistic that the internet would help foster a democratic culture, quickly learned it could also lead to political polarization. Despite this notion, his self-described obsession with politics continues today.

"It's a puzzle," Warner said of his passion for watching politics. "For example, I love watching people perform in the debates, and then seeing the reaction afterward from the media and the polls. I follow politics like some people follow their favorite pop culture, sports or hobbies. It's entertaining. The higher the stakes, the more compelling the content."

Warner reached out to two colleagues in MU's Department of Communication to help create and test his exercise -- Haley Kranstuber Horstman, an associate professor of communication at MU, and Cassandra Kearney, an assistant teaching professor of communication at MU. Horstman has experience using narrative writing in the context of health and family communication, and Kearney focuses on issues of communication and violence. Together, the researchers asked a group of 179 college students to test their theory.

First, each student was asked in an online survey to self-report their political beliefs. Using this information researchers could determine the following imaginary scenario -- the student finds a hypothetical classmate's Twitter profile, and upon reading six of their classmate's tweets, discovers the classmate is strongly political with different beliefs than the student. The tweets were modeled after actual partisan tweets, and designed to provoke angst in the reader.

Upon rating the level of angst toward the author of the tweets, each participant was randomly assigned one of three types of narrative writing exercises:

First-person perspective-taking: Describe a scene in which this hypothetical classmate was assigned to deliver a class presentation on an issue they cared deeply about in their favorite class. Something goes wrong with the presentation, and their classmate has to work creatively to salvage the project in order to get an A and pass the class.

Cooperative contract: Participants were asked to write about a non-political task in which they cooperated with the author of the tweets, such as creating recruitment materials for Mizzou.

Control: Participants were instructed to write a story about themselves rather than the author of the tweets.

At the end of the exercise, each participant was asked to re-evaluate their level of angst toward the author of the tweets. While other research studies on narrative writing have shown value for emotional and physical health, the researchers in this study also found narrative writing can reduce political polarization by fostering different perspectives and creating a sense of common identity.

"First, it forces people to think like someone they do not agree with," Warner said. "I think when people disagree with someone, they tend to think of them like a caricature image, or as a one-dimensional character. But, when someone has to write about that person, the character develops depth. So, by all of a sudden getting inside someone else's head like that, it's hard to develop that caricature image."

With personal protective equipment still in short supply, researchers at the University of Cincinnati examined what common household fabrics might work best as a face covering.

Next to a single-use N95 respirator or surgical mask, UC found the best alternative could be made by a hungry little caterpillar. Silk face masks are comfortable, breathable and repel moisture, which is a desirable trait in fighting an airborne virus. 

Perhaps best of all, silk contains natural antimicrobial, antibacterial and antiviral properties that could help ward off the virus, said Patrick Guerra, assistant professor of biology in UC's College of Arts and Sciences.

Studies have shown that copper, in particular, can kill bacteria and viruses on contact. And that's where the little caterpillars have their own superpower, Guerra said.

"Copper is the big craze now. Silk has copper in it. Domesticated silk moths eat mulberry leaves. They incorporate copper from their diet into the silk," Guerra said.

Many health care providers wear a surgical mask in combination with an N95 respirator. The outer covering helps prolong the life of the N95 respirator by keeping it clean. Guerra, whose wife, Evelyn, is a medical doctor, said silk might be an especially good choice for this outer cover as they perform similarly to surgical masks that are in short supply.

"Cotton traps moisture like a sponge. But silk is breathable. It's thinner than cotton and dries really fast," Guerra said.

With COVID-19 surging in parts of the United States, face masks have become a focal point of prevention.

In the UC biology lab, researchers tested cotton and polyester fabric along with multiple types of silk to see how effective a barrier each is for repelling water, representing respiratory droplets containing the virus. They found that silk worked far better as a moisture barrier than either polyester or cotton, both of which absorb water droplets quickly.

UC's study concluded that silk performs similarly to surgical masks when used in conjunction with respirators but has the added advantages of being washable and repelling water, which would translate to helping to keep a person safer from the airborne virus.

"The ongoing hypothesis is that coronavirus is transmitted through respiratory droplets," Guerra said. "If you wore layers of silk, it would prevent the droplets from penetrating and from being absorbed. Recent work by other researchers also found that increasing layers of silk improves filtration efficiency. This means that silk material can repel and filter droplets. And this function improves with the number of layers."

The study was published this month in the journal Plos One.

"We're trying to address this critical problem. Health care workers still don't have enough personal protective equipment, namely N95 respirators or basic surgical masks," Guerra said.

Previously, Guerra studied the neurobiology behind the incredible multigenerational migration of monarch butterflies across North America. Now UC students raise silk moths (Bombyx mori) in Guerra's biology lab.

UC postdoctoral researcher Adam Parlin wrote an undergraduate instruction manual for care and feeding of the moths he titled, "How to Train Your Bombyx," a riff on the DreamWorks' animated dragon movies. The cover features a picture of the adult moth. With its big head, enormous eyes and fanned wings, the silk moth indeed resembles a night fury from the films.

"These little guys are entertaining," he said.

As part of his research, Parlin studied how the caterpillars make their protective silk cocoons. When they reach a point in their life cycle, the caterpillars become manic workaholics. For 72 straight hours they spin and spin their silk to create a luxurious, breathable fortress where they can pupate safely into a fuzzy white moth.

Researchers created cardboard arenas with a wooden dowel in the center upon which the caterpillars can spin their silk cocoons. The caterpillars work methodically and nonstop, initially spinning silk from the top of the dowel at an angle to the cardboard like a tent. Once the tent is finished, they work in earnest on building their grape-sized cocoon in a corner of it.

"If the cocoon gets damaged, they just build a second layer around it," Parlin said.

The moisture-trapping cocoon provides an ideal microclimate to keep the caterpillars happy despite any sudden changes in the weather.

"The silk cocoons prevent moisture from getting in and keeps the animal from desiccation or drying out," Guerra said.

Now Guerra is investigating how long the virus survives on silk and other materials.

As shortages of personal protective equipment continue to plague health care providers, Guerra said homemade masks will continue to play an important role in keeping people safe from COVID-19.

"Silk has been with us for a while -- since the days of the Silk Road," Guerra said. "It's not a new fabric, yet now we're finding all these new uses for it."

BOSTON - Light therapy is safe and has measurable effects in the brain, according to a pioneering study by researchers from the Wellman Center for Photomedicine at Massachusetts General Hospital (MGH). Senior investigators Rajiv Gupta, MD, PhD, director of the Ultra-High Resolution Volume CT Lab at MGH and Benjamin Vakoc, PhD, at the Wellman Center led the study, which was supported by a grant from the Department of Defense (DOD) and published in JAMA Network Open September 14th.

This study is one of the first, if not the first, prospective, randomized, interventional clinical trials of near-infrared, low-level light therapy (LLLT) in patients who recently suffered a moderate brain injury. If further trials support these findings, light therapy could become the first widely-accepted treatment for this type of injury.

TBI is the leading cause of traumatic injury worldwide, and an estimated 69 million people experience such an injury every year. However, there are no treatments for this condition yet, largely because the underlying biological mechanisms are not well understood and it is so challenging to do studies with actual patients in the acute stage of trauma.

"The Gulf War put TBI in the headlines," says Gupta, "because body armor had been greatly improved by then. But there were still brain injuries caused by the shock waves from high powered explosives." For a variety of reasons, the number of TBIs has increased around the globe since then, but effective treatments are still sorely needed.

For this study, a special helmet had to be designed specifically to deliver the therapy, an undertaking that required a mix of medical, engineering and physics expertise. This multidisciplinary team included Gupta, a neuroradiologist, Vakoc, an applied physicist, and others specializing in the development and translation of optical instrumentation to the clinic and biologic laboratories. Both Gupta and Vakoc are also associate professors at Harvard Medical School.

"For this study, we designed a practical, near-infrared treatment based on Wellman Center research and working directly with DOD on the vexing problem of TBI, a condition faced by so many," says Rox Anderson, MD, the center's director.

Another challenge was optimizing the wavelength of the near-infrared LLLT. "Nobody knows how much light you need to get the optimal effect," explains Lynn Drake, MD, one of the study co-authors and director of business development at the Wellman Center. "We tried to optimize the wavelength, dosing, timing of delivery, and length of exposure." This was done through a series of pre-clinical experiments led by Anderson. These included multiple preclinical studies led by Michael Hamblin, PhD. Anderson and Hamblin are both co-authors on this paper.

Near-infrared LLLT has already been considered for multiple uses, but to date, few if any studies of this technology have been tested and none in patients with TBI. It has been studied in stroke patients and Wellman basic laboratory research suggests it is neuroprotective through a mechanism mediated by specialized intracellular organs called mitochondria. It took several years of research at Wellman to understand the basic mechanism prior to the clinical trial.

The randomized clinical trial included 68 patients with moderate traumatic brain injury who were divided into two groups. One group received LLLT, via the special helmet, which delivered the light. Patients in the control group wore the helmet for the same amount of time, but did not receive the treatment. The helmet was designed by Vakoc's team at Wellman. During the study, the subjects' brains were tested for neuroreactivity using quantitative magnetic resonance imaging (MRI) metrics and the subjects also underwent neurocognitive function assessment.

MRI was performed in the acute (within 72 hours of the injury), early subacute (2-3 weeks), and late subacute (approximately three months) stages of recovery. Clinical assessments were performed during each visit and at six months, using the Rivermead Post-Concussion Questionnaire, with each item assessed on a five-point scale.

Twenty-eight patients completed at least one LLLT session and none reported any adverse reactions. In addition, the researchers found that they could measure the effects of transcranial LLLT on the brain. The MRI studies showed statistically significant differences in the integrity of myelin surrounding the neurons of treated patients versus the control group. Both these findings support follow-up trials, especially since there are no other treatments for these patients.

The study also showed the light does impact the cells. While it is well established that cells have light receptors, "going into this trial, we had several unanswered questions such as whether the light would go through the scalp and skull, whether the dose was sufficient, and whether it would be enough to engage the neural substrates responsible for repair after TBI," says Gupta.

It's important to note, he adds, that for this initial study, the researchers focused on patients with moderate traumatic brain injury. That helped to ensure their study could have statistically significant findings because patients in this category are more likely to demonstrate a measurable effect. "It would be much more difficult to see such changes in patients with mild injuries and it is quite likely that in patients with severe brain injuries the effect of light therapy would be confounded by other comorbidities of severe trauma," says Gupta.

He adds that researchers are still very early in the development of this therapy, and it is not known if it could be applied to other types of brain injury, such as chronic traumatic encephalopathy (CTE), which has received a lot of public attention over the last few years. CTE is a progressive degenerative disease associated with a history of repetitive brain trauma such as that experienced by certain types of athletes, most notably football players.

This study opens up many possibilities for broader use of photomedicine. "Transcranial LED therapy is a promising area of research, with potential to help various brain disorders where therapies are limited," says Margaret Naeser, PhD, a prominent researcher in photomedicine and research professor of Neurology at Boston University School of Medicine. She was not affiliated with this particular study.

Having elevated cholesterol during the teens or early twenties increases a person's risk of having a heart attack, stroke or other cardiovascular event during middle age. That is the finding a new landmark study led by researchers at the University of Maryland School of Medicine (UMSOM). This increased risk persists even in those who were able to get their cholesterol levels down to a healthy level before reaching their late thirties. The research makes a strong case for doctors to intervene early to treat high levels of low-density lipoprotein (LDL), the so-called "bad" type of cholesterol, the study authors contend. It also provides guidance for future intervention studies aimed at stemming the worldwide epidemic of heart disease and stroke.

The study, entitled "Time Course of LDL Cholesterol Exposure and Cardiovascular Disease Event Risk", was published today in the Journal of the American College of Cardiology and relied on data from the Coronary Artery Risk Development in Young Adults Study (CARDIA). This ongoing study, funded by the National Heart, Lung, and Blood Institute, began 35 years ago, recruiting 5,000 young adults aged 18 to 30. It has been tracking this cohort ever since to understand how individual characteristics, lifestyle and environmental factors contribute to the development of cardiovascular disease later in life.

"We found having an elevated LDL cholesterol level at a young age raises the risk of developing heart disease, and the elevated risk persists even in those who were able to later lower their LDL cholesterol levels" said study leader Michael Domanski, MD, a Professor of Medicine at UMSOM. For instance, two people with the same cholesterol level at age 40 may have very different risks of having a heart attack or stroke with risk being higher for the person who had higher cholesterol as a teenager.

"Damage to the arteries done early in life may be irreversible and appears to be cumulative," Dr. Domanski said. "For this reason, doctors may want to consider prescribing lifestyle changes and also medications to lower high LDL cholesterol levels in young adults in order to prevent problems further down the road."

To conduct the study, the researchers used complex mathematical modeling to understand how cardiovascular risk (heart attack, stroke, blood vessel blockages, and death from cardiovascular disease) rises with increasing cumulative "exposure" to LDL cholesterol over an average of 22 years. They found that the greater the area under the "LDL curve" - which measured time of exposure and level of LDL cholesterol over time -- the more likely participants were to experience a major cardiovascular event.

"Interestingly and importantly, we also found it was not just the area under the curve that accounted for the difference in risk but also the time course of the exposure," study co-author Charles Hong, MD, PhD, the Melvin Sharoky, MD, Professor in Medicine at UMSOM. "This underscores the importance of regular cholesterol screenings beginning in early adulthood to help reduce this time of high exposure."

While the medical establishment understands the importance of managing high LDL cholesterol levels to lower heart risks, there is little consensus on how aggressively to intervene in young adults who may not experience a heart attack or stroke for decades. The American College of Cardiology's current cholesterol management guidelines recommend using lifestyle measures to lower high LDL levels during the teenage years. This includes exercise, maintaining a healthy body mass index, and following a healthy diet low in saturated animal fats. The guidelines recommend that doctors consider prescribing cholesterol-lowering medications like statins to prevent heart disease in those ages 20 to 39 who have elevated cholesterol levels, especially if they have a family history of early-onset heart disease.

Researchers from the National Heart, Lung, and Blood Institute, George Washington University, Northwestern Feinberg School of Medicine, University of Alabama School of Medicine, the University of Toronto and the Icahn School of Medicine at Mount Sinai were co-authors on this study.

"Cardiovascular disease remains the biggest killer in the world, and this new finding provides a potential way to save many lives," said E. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor and Dean, University of Maryland School of Medicine. "The medical community should sit up, take notice, and respond to this important new evidence."

The COVID-19 crisis has taken a psychological toll on people of all ages, but one group especially affected is teenagers. School closures and enforced social distancing have cut off many teens from major means of psychological support, putting them at higher risk of developing anxiety and depression.

To learn about how teens (as well as other age groups) might avoid experiencing these emotional difficulties, a new study has focused on a sample of adolescents who, even in normal times, are particularly prone to stress: youth who have entered puberty earlier than their peers.

The study examined brain scans of American teenagers taken five years ago and self- and parent-reported surveys about mental wellbeing and progression through puberty, both before and after the pandemic lockdown started in March 2020.

The researchers found that teenagers who showed greater connectivity, or interconnectedness, in a set of particular brain regions were less likely to experience pandemic-related depression and anxiety, even if they had started puberty early relative to their peers. The results highlight the importance of the so-called executive control network, or ECN, in dealing with stress and adapting to new challenges.

"Our findings suggest that executive functioning in our brain plays a key role in protecting against risk factors that worsen symptoms of depression and anxiety during stressful, uncertain times," said Rajpreet Chahal, a postdoctoral fellow in the Stanford Department of Psychology and lead author of the recent study, published in the journal Biological Psychiatry: Cognitive Neuroscience and Neuroimaging. "These results are very relevant for teenagers, as well as people of all ages, in this era of COVID-19."

The study adds to researchers' growing understanding of how the ECN supports cognitive processes, such as regulating emotions and navigating new situations, that can fortify people from developing psychological problems. In this way, engaging and strengthening the ECN through training and/or therapy could help buffer against not just COVID-19-related stress, but also the ups and downs of daily life.

"These findings raise the question of whether young people would benefit from executive function training," said Ian Gotlib, senior study author and the David Starr Jordan Professor in the Department of Psychology at Stanford's School of Humanities and Sciences. "It's possible that such a targeted intervention would reduce the chances of experiencing psychopathologies like depression and anxiety in the face of stress, like a pandemic, and especially for higher-risk teens going through early puberty."

Teens in time

The study's participants are a group of around 200 Bay Area teenagers originally recruited between 2013 and 2016. Gotlib's lab has followed this cohort to track how early life stress affects psychology and neurodevelopment, including brain function and structure. One of the main motivations behind the work is to learn more about the increasing rates of depression and suicidal behaviors among adolescents.

The teenagers had all received brain scans using functional magnetic resonance imaging (fMRI) upon enrolling in the study. Scans of this sort reveal areas of greater blood flow within the brain, indicative of the activation of those brain regions. The regions composing the ECN are found primarily within the frontal lobes, including the dorsolateral prefrontal cortex, and parietal lobes, located in the top of the brain. These regions ramp up their activity when people perform certain cognitive control tasks that require, for instance, suppressing an automatic response, paying or shifting attention and planning ahead.

In some people, the brain regions comprising the ECN activate more closely in time together. Chahal and Gotlib had been exploring the influence of this synchronization - known as coherence - in typically-developing teens and those who are maturing faster than their peers. The reasons for the latter group being more prone to anxiety and depression are both social and biological. Socially, teens can experience stress from being "different" than their peers - for example, with boys growing body hair and their voices changing, and with girls having their first menstruation and developing breasts. Biologically, the release of hormones also exacerbates tendencies toward experiencing psychological difficulties. Because puberty can last from two to five years, teens enrolled in the study at various times were in different stages of puberty, with some barely beginning the transformation and others already in the midst of this developmental period.

This overall line of research on ECN coherence and the influence of pubertal onset, however, ground to a halt when COVID-19 struck earlier this year. Yet Gotlib's group recognized that the pandemic offered a unique opportunity. With its social isolation, as well as the associated health and financial uncertainties, the pandemic served as a novel, profound stressor on the study group.

"This global pandemic, which is hopefully only a once-in-a-lifetime event for these kids, has presented a powerful way to test some of our hypotheses regarding the ECN, puberty and mental health," said Chahal.

Identifying and helping those at risk

The Stanford researchers prepared and administered online questionnaires to the cohort. The questions assessed the children's general psychological state and their perceived progression through puberty. The research team associated the responses with the original brain scans and with measures of the children's advancement through puberty when the scans were obtained.

A clear relation came through in the result, Chahal said. Teens who had exhibited low ECN coherence generally reported more symptoms of anxiety and depression during the pandemic than did those teens whose ECNs had been shown to activate more coherently.

"It's very compelling that the functional architecture of the brain that supports executive functioning seems to have such an integral role in coping with stress," says Chahal. "Prior studies have shown this to an extent, but not in this particular age group and not accounting for the social conditions caused by the pandemic."

A promising avenue for further study is identifying teenagers and people of all ages who are at greater risk of psychological distress on the basis of their brain circuitry. These high-risk individuals could be further evaluated to see if they might respond favorably to therapy or medication, especially as the challenges of the COVID era continue.

"An important takeaway is that we can start to look at predictors of mental health during COVID in susceptible, vulnerable children and adolescents," said Gotlib. "We're just starting to get a sense of the factors that increase not only risk but also resilience, to the effects of the pandemic."

Accurate detection and characterization of SLNs are crucial in cancer staging and making therapeutic decisions. At present, the clinical gold standard used to detect SLNs is to label them with blue dye or a radioactive nanocolloid and then perform SLN biopsy. But these methods have drawbacks, radioscintigraphy has relatively poor spatial resolution, and blue dye will quickly label downstream LNs, leading to difficulties recognized SLN from other nodes. In addition, the removal of the SLN may cause some side effects, such as lymphedema, shoulder dysfunction, and arm numbness. Therefore, the ideal method for detecting SLN needs to have the following characteristics: 1) The probe can quickly enter the lymphatic system and retain in the SLN for a while. 2) The probe should contain a specific ligand for the selective targeting of breast cancer cells. 3) Imaging technique requires sufficient sensitivity and spatial resolution to detect the distribution of tumor cells in the entire SLN.

LN enlargement can occur during both tumour cell invasion and under inflammatory conditions. Therefore, the accurately identify the status of the SLN intraoperatively will help surgeons choose appropriate treatment regimen and minimize the complications caused by unnecessary LN removal. Although various nanoprobes based on passively targeting macrophages in SLN combined with imaging techniques have been developed to predict the metastatic status of SLNs, few can distinguish metastatic SLNs from inflamed LNs in vivo.

In a new paper published in Light Science & Application, a team of scientists, led by Professor Zhihong Zhang and Professor Qingming Luo from Wuhan National Laboratory for Optoelectronics-Huazhong University of Science and Technology, Wuhan, Hubei, China, and School of Biomedical Engineering, Hainan University, Haikou, Hainan, China, and co-workers have developed a CD44 and SR-B1 dual-targeting hyaluronic acid nanoparticle (5K-HA-HPPS) loaded with the near-infrared fluorescent/photoacoustic dye DiR-BOA for imaging SLNs in breast cancer. Due to the small size, negative charge, and target ligand, 5K-HA-HPPS can rapidly (12 h) in pLN. More interestingly, they found that photoacoustic signals from 5K-HA-HPPS showed a significantly distinct spatial distribution among LNs of different statuses, which the signals were mainly distributed within tumour metastatic SLNs but at the peripheries of normal and inflamed LNs. The ratio of PA intensity (R) at the centre of the LNs compared with that at the periphery in the 5K-HA-HPPS group was 5.93 ± 0.75 for T-MLNs, which was much higher than that for the Inf-LNs (R = 0.2 ± 0.07) and N-LNs (R = 0.45 ± 0.09). The reported method and technique provide a new strategy for accurately identifying the status of SLNs during breast cancer surgery and facilitate the implementation of appropriate tumour treatment strategies.

Fluorescence imaging showed that 5K-HA-HPPS enhanced in both T-MLNs and Inf-LNs, indicating that T-MLNs and Inf-LNs cannot be distinguished according to their fluorescence intensities. Here wide-field fluorescence imaging is two-dimensional imaging, which possesses the advantage of sensitivity, convenience, and non-invasiveness for long-term monitoring, but it cannot distinguish whether the fluorescent signal is located inside the LN or at the periphery of the LN. By providing deep penetration and a high spatial resolution, photoacoustic microscopy has a great potential for the 3D visualization of photoacoustic signal distribution in intact LNs.

Both tumour cell infiltration and inflammation result in the enlargement of SLNs. Therefore, whether SLN enlargement is caused by the metastasis of tumour cells or inflammation should be determined before SLN resection. The presented technique possess the ability to distinguish metastatic SLNs from inflamed LNs, thus will expected to provide an in vivo detection method for quickly identifying whether the SLN has tumor metastasis and will reduce the complications caused by unnecessary LN removal during breast cancer surgery, which has potential clinical application value.

CHAPEL HILL, N.C.--One in seven black women with breast cancer had delays in starting treatment, and black women also had extended duration of treatment, according to a study led by UNC Lineberger Comprehensive Cancer Center researchers.

In the journal Cancer, Melissa Troester, PhD, Marc Emerson, PhD, and their colleagues report that Black women were more likely than white women (13.4% vs. 7.9%) to have the start of the care delayed by at least 60 days after diagnosis. Black women were also more likely to have longer duration of treatment, as were women under the age of 50 of all races.

The study assessed a variety of patient-reported factors for their impact on delaying start or prolonging duration. While access to care, tumor status and socioeconomic status did affect treatment start times, these factors had greater impact on the length of care. It was also notable that socioeconomic status was not as strongly connected to treatment delay as race.

"Our study found that Black women experienced delays in both treatment initiation and duration more often than white women. Even among women with low socioeconomic status, we still saw fewer delays among white women, underscoring the disparate experience of Black women, who appear to experience unique barriers," said Emerson, the paper's first author and postdoctoral fellow at UNC Lineberger and UNC Gillings.

Although they have a similar risk of developing breast cancer, Black women are 42% more likely than white women to die from the disease. Among women younger than 45, the mortality rate for black women is more than double that of white women.

The researchers analyzed the course of care of 2,841 women enrolled in the Carolina Breast Cancer Study Phase III, which is part of a population-based study UNC Lineberger and UNC Gillings School of Global Public Health launched in 1993 to investigate how the causes, treatments, and long-term outcomes of breast cancer differ between Black and white women. The women included in the new analysis were between 24 and 74 years of age at time of diagnosis, had stage 1, 2 or 3 breast cancer, and approximately half were Black.

The study used latent class analysis to group women according to a wide range of factors related to socioeconomic status, barriers to accessing care, and treatments and other patient factors that contribute to racial disparities. This aggregation allowed the investigators to consider how aggregated factors that may work together to define health care experiences.

"Describing and studying the complex set of factors that influence women's health care experience is a challenge, but this approach helps develop a more complex understanding," said Troester, the study's senior author and professor of epidemiology at the UNC Gillings and professor of pathology and lab medicine at UNC School of Medicine. "We observed that the duration of treatment was a particular sensitive indicator of access. This suggests that in addition to helping patients start treatment on time, we also have to work toward improving access so treatment doesn't drag on."