An experimental COVID-19 vaccine known as mRNA-1273 was well-tolerated in older adults, according to new research in the 

The vaccine was co-developed by the Cambridge, Massachusetts-based biotechnology company, Moderna Inc., and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Beginning on March 16, 2020, the Phase 1 trial began and expanded for older-adult enrollment one month later. As previous studies have shown, older adults are more vulnerable to complications of the virus and are important when measuring the vaccine’s efficacy and safety.

The trial enrolled 40 healthy volunteers: 20 adults aged 56 to 70 years, and 20 adults aged 71 years and older. Ten volunteers in each age group were given a lower dose of the vaccine (25 µg), and 10 volunteers in each age group received a higher dose (100 µg). After one month, volunteers received a second dose of the same vaccine at the same dosage.

Some volunteers reported fever and fatigue after vaccination. Results indicated a positive immune response in those vaccinated, with evidence of robust binding and neutralizing antibodies against the virus.

These results, according to researchers, further support testing the investigational vaccine in older adults in this ongoing large Phase 3 trial.

NIH Clinical Trial of Investigational Vaccine for COVID-19 Begins. News release. National Institute of Allergy and Infectious Diseases; March 16, 2020.

Investigational COVID-19 vaccine well-tolerated and generates immune response in older adults. News release. National Institutes of Health; September 29, 2020.

Phase 3 Clinical Trial of Investigational Vaccine for COVID-19 Begins. News release. National Institute of Allergy and Infectious Diseases; July 27, 2020.

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Investigational COVID-19 vaccine well-tolerated in older adults

She speaks here about how different disciplines worked together to achieve optimal patient care. The hospital system mobilized its resources in many ways, including establishing a Virtual COVID Clinic. You can read more about that 

It was shortly after the hospital diagnosed its first COVID-19 positive patient that officials realized there would be a need for a virtual clinic to monitor the high-risk population. Medical staff were being challenged and taxed in other ways, including working with different disciplines throughout the hospital.

in the midst of the crisis, check out “Dispatches During COVID-19.

Watch the full video interview with Dr. Aziz 

Podcasts

In this episode of Pap Talk by Contemporary OB/GYN, Senior Editor Angie DeRosa interviews Aleha Aziz, MD, an ob/gyn at Columbia University’s Irving Medical Center in New York. Dr. Aziz was one of many fellows involved with caring for patients during the peak of the COVID-19 pandemic in New York City earlier this year.

S2E4: The fellow on the frontlines of COVID-19

Learn more about the presentation, diagnosis, management, and treatment of the rare vulvar infection in this peer-reviewed article from the 

Poll

Test your knowledge of this rare vulvar condition

Dr. Santoro highlights just some of the content from the scientific program, including cardiovascular disease, the effect of menopause on vasomotor symptoms; genitourinary syndrome of menopause; and hormones of menopause, including a look into FSH as an active driver of menopause.

All presentations have been pre-recorded and now are available for on-demand viewing beginning Sept. 28 through Sept. 21, 2021. Live Q&A sessions will be held from Oct. 5 to Oct. 9. The full program can be found 

Videos

In this video, Senior Editor Angie DeRosa interviews Nanette Santoro, MD, Chair of the 2020 Scientific Program Committee for the Virtual Annual Meeting of the North American Menopause Society (NAMS). 

Highlights from NAMS 2020 Virtual Annual Meeting

This article is based on information presented at the 2020 Virtual Annual Meeting of the North American Menopause Society (NAMS). According to NAMS, all presentations have been pre-recorded and now are available for on-demand viewing beginning Sept. 28 through Sept. 21, 2021. For more information, click 

The findings are independent of sleep risk factors and depressive symptoms.

“I have a longstanding interest in understanding how trauma is related to poor sleep and health,” said first author Karen Jakubowski, PhD, a postdoctoral scholar in psychiatry at the University of Pittsburgh in Pennsylvania. 

“Although some past studies have found that trauma is connected to poor sleep, these studies measured sleep at only one time point. We realized there was a gap in our knowledge of whether trauma is related to poor sleep measured at multiple points over time, particularly in midlife women.”

The investigators used both objective and self-report measures of sleep, “which makes this research even more novel and exciting,” Dr. Jakubowski told 

The ongoing study, which is being conducted at the University of Pittsburgh, consists of a cohort of midlife women, aged 40 to 60 at baseline, who had participated in a previous study on menopausal hot flashes and cardiovascular health from 2012 to 2015.

The women were invited to return to the laboratory 5 years later for a follow-up visit between 2017 and 2020.

Of the 296 women assessed at baseline, 72% were White and 28% Black, with an average age of 54. For the follow-up visit, 166 women were evaluated.

At both baseline and follow-up, women reported adult trauma (Brief Trauma Questionnaire), demographics, depressive symptoms, sleep quality (Pittsburgh Sleep Quality Index [PSQI]) and apnea.

They also provided physical measures of height/weight, as well as a 3-day objective sleep assessment via actigraphy: duration and wake after sleep onset (WASO).

At baseline only, women reported childhood trauma (Child Trauma Questionnaire).

Linking childhood trauma (any/none) and adult trauma (any/none) at baseline with poor sleep (duration <7 hours, WASO ≥31 minutes, PSQI >5) across both baseline and follow-up visits were then assessed.

At baseline, 44% of women reported childhood trauma, compared to 60% who reported adult trauma.

Persistently poor sleep duration, WASO and sleep quality was observed in 61%, 60%, and 33% of women, respectively, at both baseline and follow-up visits.

Childhood trauma was related to persistently poor WASO: odds ratio (OR) 2.32; 95% confidence interval (CI): 1.11 to 4.84 (

Adult trauma also was connected to persistently poor sleep quality: OR 2.13; 95% CI: 1.01 to 4.52 (

However, trauma was unrelated to persistently poor sleep duration.

“We were surprised that trauma was unrelated to women’s sleep duration,” Dr. Jakubowski said. “Our results suggest that trauma history is more connected to disrupted and poor-quality sleep in midlife women, rather than how long women are sleeping.”

To improve sleep quality in this population, Dr. Jakubowski said she believes it is important that women allow themselves time to wind down at night, prior to going to bed. “This may involve doing an activity that they find restful or relaxing, without phones or screens if possible, to help promote the transition from our busy lives to sleep,” she said.

The authors hope that their work inspires further research on the lasting effects of trauma on sleep and health in midlife women, “and aids in the development of future interventions that can tailor and improve sleep in women who have experienced trauma,” Dr. Jakubowski said.

Dr. Jakubowski reports no relevant financial disclosures.

Poor sleep occurs frequently among midlife women, which is significantly linked to childhood and adult trauma, according to a prospective study presented at the 2020 Virtual Annual Meeting of the North American Menopause Society (NAMS).

Trauma’s relation to poor sleep and health in midlife women

In a recent interview, David Zetter, Founder of Zetter HealthCare LLC, told 

that practices should take advantage of federal and state programs that were set up to help small businesses, including medical practices, that were financially harmed by the pandemic.

A recent interview from Medical Economics discussed ways for medical practices to take advantage of federal- and state-funded programs. 

Expert discusses emergency financing sources for practitioners 

, virtual visits are making their way to the forefront of health care.

 offers practical advice to ob/gyns on conducting virtual Well Woman visits and provides practitioners with all the information needed to conduct a successful virtual assessment.

recently held a Q&A-style interview with 

Caroline Brennan, PhD, Vice President of the Health Division of Escalent, a health care research firm, to learn more about telehealth strategies and recent trends.

Medical Economics: How much of the reluctance to use telehealth comes from not having a comfort level with the technology? And how can doctors help patients overcome that?

: What's interesting is when we started our research on this, we thought that the technology barrier would be significant. And what we found is not that many people expressed concern about technology, about not being tech-savvy, or not having some tools at home, to have these telehealth visits. But nonetheless, any time any of us go on a new website and login and use technology for the first time, there's always some apprehension. So I think what the doctors’ offices can do is provide very detailed login information, exactly what needs to be downloaded, how it's going to work, maybe even provide some test runs, so that people can get more comfortable with it before they actually show up for that first appointment.

Medical Economics: Is there a certain patient demographic that prefers telehealth?

: We found in our study that people of all walks of life were using telehealth—all ages, all income levels, socio-economic backgrounds. However, we did see that those who were seniors, or older folks, as well as those with lower incomes, we're not using it quite at the same rate as others, which is interesting, especially for the seniors. They might be a particular group of people who would really benefit from telehealth not just during COVID to reduce their risk of exposure, but longer-term, in terms of mitigating some transportation concerns that they have, or especially if they have a lot of medical appointments.

Medical Economics: What does the long-term future of telehealth look like in the US?

: Based on what we're hearing, it certainly is not going to replace in-person visits. But I do think it will remain as a viable option in a lot of cases for a lot of people. At first, for very specific conditions and situations. But I think telehealth is here to stay and really anything that will increase people's access to health care is a win in my book.

In a recent Q&A-style interview, Medical Economics spoke with Caroline Brennan, PhD, Vice President of the Health Division of Escalent, a health care research firm, to learn more about telehealth strategies and recent trends. 

Expert insight on telehealth strategies and trends

The Center will aim to further the agency’s goal of advancing digital health technology, including mobile health devices, software as a medical device (SaMD), wearables used with medical devices, and technology to study medical products.

“Today’s announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings. The Digital Health Center of Excellence will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff,” 

said FDA Commissioner Stephen M. Hahn, MD

The agency will appoint Bakul Patel as the first director, who has been leading regulatory and scientific efforts related to digital health devices at the FDA since 2010.

The U.S. Food and Drug Administration (FDA) has announced the launch of its Digital Health Center of Excellence, which will be within the Center for Devices and Radiological Health (CDRH). 

New Digital Health Center of Excellence from FDA

, gender-affirming medical care is crucial for the wellbeing of transgender and nonbinary patients.

Many children and adolescents who are transgender or nonbinary may seek gender-affirming care at later ages. A new study in 

investigated whether there was a relationship between the age of presentation for gender-affirming medical care and mental health problems.

Terminology for ob/gyns to use when treating transgender patients

The researchers concluded that both late pubertal stage and older age are tied to worse mental health among adolescents who are gender incongruent and presenting for gender-affirming care. These results provide more data on how this group is vulnerable and in need of appropriate care.

For more information on this study and its findings, visit 

A new study in Pediatrics investigated whether there was a relationship between age of presentation for gender-affirming medical care and mental health problems. 

Relationship between mental health and age of gender-affirming medical care

Using cannabis for menopause symptom management is common, at least in a sample of midlife women veterans from across California.

The study, which was presented at the 2020 Virtual Annual Meeting of the North American Menopause Society (NAMS), found that among 231 women with a mean age of 55.95 years, 27% reported that they currently or previously used cannabis for managing menopause symptoms, including hot flashes, night sweats, insomnia, and genitourinary symptoms.

An additional 10% of participants expressed interest in using cannabis in the future to manage their menopause symptoms.

Principal investigator Carolyn Gibson, PhD, MPH, a psychologist and health services researcher at the San Francisco Veterans Affairs (VA) Health Care System, said, “These findings come from a larger study I conducted to examine the experience of menopause and menopause-related care among midlife and older women veterans, which is an understudied population that comprises over half of the women we serve in the VA.”

Dr. Gibson was inspired to add questions about cannabis use for menopause symptom management because, over the past several years, popular press articles about its use started appearing regularly in her newsfeed.

“It seems apparent that as cannabis use becomes increasingly mainstream, a growing number of midlife and older women are interested in or using cannabis to help manage menopause symptoms,” Dr. Gibson said. “However, we had no data on actual numbers, or if use is helping or harming women.”

Cross-sectional data were gleaned from the Midlife Women Veterans Health Survey, which was an observational study of women veterans, aged 45 to 64, who were enrolled in VA health care across Northern California. Data were collected between March 2019 and May 2020.

Cannabis use was more frequently reported among women reporting hot flashes (67% vs. 50% for non-users; 

But there were no differences observed for other menopause symptoms between the two groups.

“I was expecting some women to report cannabis use for menopause symptom management, but was a little surprised to see a rate approaching 30%,” Dr. Gibson said. “This is in comparison to 19% of women in the sample who reported menopausal hormone therapy use.”

Dr. Gibson also expected to find some differences, such as cannabis use for menopause symptoms being more common among women who were younger or less engaged in VA care, but this was not the case.

The study did not address frequency of use and/or potency of the cannabis.

“Patients may not always disclose cannabis use, especially in the VA health care system, where cannabis is considered illegal under federal guidelines, regardless of state laws,” Dr. Gibson said. “Nonetheless, providers should be aware that their perimenopausal and postmenopausal patients may be using cannabis to manage their menopause symptoms.”

There is much to be learned about the potential benefits and harms of cannabis use, particularly related to menopause and aging, she said. “However, existing evidence raises concerns about its impact on cognition, cardiovascular health and mental health,” she said.

Future areas of research include who is using cannabis for menopause symptom management, what type of cannabis products they are using, what symptoms they are targeting and whether cannabis is actually effective.

“We also need to know whether our numbers would look the same outside of Northern California, and how typical patterns of use impact health and functioning among perimenopausal and postmenopausal women,” Dr. Gibson said.

Dr. Gibson reports no relevant financial disclosures.

This article is based on information presented at the 2020 Virtual Annual Meeting of the North American Menopause Society (NAMS). According to NAMS, all presentations have been pre-recorded and now are available for on-demand viewing beginning Sept. 28 through Sept. 21, 2021.

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