Contemporary Clinic spoke with NAPNAP President Jessica Peck, DNP, APRN, CPNP-PC, CNE, CNL, FAANP, FAAN and NAPNAP Secretary Jennifer Sonney, PhD, APRN, PPCNP-BC, FAANP, about their latest study regarding the pandemic's impact on pediatric-focused nurse practitioner workforce.

Peck and Sonney share their inspiration for conducting the study, highlights of the findings, and what they hope this study will teach other NPs about the workforce. 

https://www.jpedhc.org/article/S0891-5245(21)00094-8/fulltext

Videos

The Impact of COVID-19 On Pediatric Advanced Practice Registered Nursing Workforces

interviewedLea Davis, PhD, an associate professor of medicine in the Department of Medicine at Vanderbilt University Medical Center and an investigator in the Vanderbilt Genetics Institute, on a recent study she co-authored that was published in 

 on the epidemiology of functional seizures among adults treated at a university hospital.

Could you explain further the novel association in your findings between functional seizures and cerebrovascular disease?

 Yeah. So, in our data, what we saw was basically that that the presence of functional seizures and the presence of cerebrovascular disease, or more specifically stroke, tended to co-occur at a rate higher than what we would expect by chance, just based on how common those 2 conditions are independently.

So, we saw them actually occurring together more often than we would expect. We did do some work to try to figure out which might be coming first, the functional seizure condition or the stroke event.

The challenge with that though is that patients with functional seizures often experience like a 7 to 8 year diagnostic odyssey, so by the time they actually get diagnosed with functional seizures they may have been having functional seizures for a very long time and that can be really hard to tease apart in the medical record.

So, that's part of our challenge in trying to understand the relationship between these 2. I will also say that it's not uncommon for stroke patients to experience or to develop epilepsy after a stroke, and so one of the recommendations that we make in the paper is that, for anybody who's experiencing seizures post-stroke who is not pretty quickly responding to anti-epileptic medications, they should be referred to a video EEG to determine if this is a functional seizure condition or epileptic seizures.

Lea Davis, PhD, of the Vanderbilt University Medical Center and Vanderbilt Genetics Institute, discussed the results of her research showing a novel association between functional seizures and cerebrovascular disease.

Novel Association Observed Between Functional Seizures, Cerebrovascular Disease

Patients with chronic refractory cough (CRC) may benefit from behavioral cough suppression therapy (BCST). In a session of the 2021 American Cough Conference, Laurie Slovarp, PhD, CCC-SLP, associate professor at the University of Montana in Missoula, said increased awareness of BCST is needed for clinicians and patients to know it as a noninvasive, efficacious, and inexpensive form of cough treatment, as well as to understand how this therapy works and how to identify eligible candidates.

According to Slovarp, BCST is known by various names, including speech pathology treatment for chronic cough, respiratory retraining, and cough-suppression physiotherapy.

“Just about every single paper refers to it by a different name,” she said. “If you see ‘speech pathology’ and ‘cough’ together, you can bet that we’re probably talking about the same therapy.”

Prior to using BCST, patients will often see multiple care providers, undergo multiple tests, and try multiple medications, she said.

However, up to 88% of patients with CRC using BCST have shown a reduction in cough severity through published studies. These reductions occurred in cough frequency and sensitivity, while also increasing quality of life for patients.

“These are all patients that have already failed just about every other medical treatment available to them,” Slovarp said.

A survey study published by Slovarp in 2021 investigated the post-BCST satisfaction of 164 patients in the United States and Australia. It found that 58% of patients reported being “quite satisfied” or “completely satisfied” following therapy. The mean change of 6.6 from the Leicester Cough Questionnaire was significant, according to Slovarp.

“There’s pretty reasonable efficacy data on BCST,” she said. “These patients are not just getting better a little bit, many of them have a pretty dramatic improvement.”

According to Slovarp, onset of CRC often occurs with a cough-inducing event, such as a respiratory virus. CRC may present itself in various ways, from a once-a-week coughing fit to a cough that induces gagging or vomiting.

“In my clinic, I see a wide variety of severity,” she said.

BCST is often determined with extensive case history, oral mechanism exam that may find muscle tension or tenderness in the neck, shoulders and suprahyoid, voice evaluation, urge-to-cough testing, and validated patient-report questionnaire.

“The biggest thing for me is the case history,” she said. “Most of the patients we see have been coughing for years.”

Treatment options may be educating patients about coughing including the safety of cough suppression, training patients to suppress coughing; increasing awareness of cough triggers and a pending cough; management of laryngopharyngeal reflux and postnasal drip, voice therapy, and, if needed, a challenge.

Cough-control breathing, relaxation, and swallowing techniques, as well as distractions, and resonant voicing are some of the methods employed in BCST.

“Over time, with suppression, you will feel a reduction in urge to cough,” she said.

Slovarp L. Issues in clinical cough management: Behavioral management of chronic refractory cough. Presented at: American Cough Conference; virtual. June 11, 2021. 

https://app.socio.events/NzMwMw/Agenda/85150/Session/385292

Articles

Noninvasive, efficacious treatment options are available to help patient outcomes and improve quality of life.  

Using Behavioral Management to Control Chronic Refractory Cough

Officials with the FDA have approved azelastine hydrochloride 0.15% (Astepro Allergy; Bayer) as an OTC product for the temporary relief of nasal congestion, runny nose, sneezing, and itchy nose associated with upper respiratory allergies such as hay fever. According to Bayer, the approval is the FDA’s first for a steroid-free, antihistamine nasal spray for allergies available OTC in the United States.

More than 50 million Americans are affected by allergies each year, according to Bayer. Azelastine hydrochloride 0.15% is indicated for adults and children 6 years of age and older. 

According to Catherine Vennat, vice president and general manager, GM Bayer Consumer Health US, azelastine HCI 0.15% addresses an unmet need for patients with allergic rhinitis. The approved OTC formulation is full prescription strength and can provide relief from allergy nasal symptoms that will last up to 24 hours.

Azelastine is currently only available with a prescription in the United States. According to Bayer, azelastine hydrochloride 0.15% is expected to become available in retail locations in early 2022.

Currently, OTC allergy medications includes 3 major classes: antihistamines, intranasal steroids, and mast cell stabilizers. Azelastine hydrochloride 0.15% will be the only OTC antihistamine nasal spray for indoor and outdoor allergy relief.

FDA Approves Astepro Allergy Nasal Spray for Over-the-Counter Use in the United States [news release]. June 17, 2021; Bayer. Accessed June 17, 2021. 

https://www.businesswire.com/news/home/20210617005872/en/FDA-Approves-Astepro%C2%AE-Allergy-Nasal-Spray-for-Over-the-Counter-Use-in-the-United-States

Astepro Allergy is the first steroid-free antihistamine of its kind to be available without a prescription.

New OTC Nasal Spray for Allergy Relief Granted FDA Approval

Mary Koslap-Petraco, DNP, PPCNP-BC, CPNP, FAANP, is a clinical assistant professor at Stony Brook University School of Nursing in New York.

The pandemic has changed life as we knew it, but COVID-19 vaccines are changing lives again, this time for the better.

Grandparents are once again able to hug their grandchildren, but those same grandchildren are still at risk for COVID-19 until we can get all of them who are medically able vaccinated. At press time, children accounted for the largest number of new cases of COVID-19, because most are still not vaccinated (AAP, 2021, April).1 Hospitalization rates for children with COVID-19 have also risen, and serious cases are being seen (AAP, 2021, June).2 From March 1, 2020, through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals aged 11 to 17 years had been reported to the CDC (USFDA, 2021, May 10).3

Most children will return to classrooms for school in the fall, if they have not done so already (Parents, 2021, March).4 Although handwashing, masks, and social distancing are essential public health measures and have slowed the pandemic, the best and most long-lasting way to protect children is to vaccinate them. The number of COVID-19 cases among individuals aged 50 years and older has dropped dramatically. A large segment of this population is fully vaccinated (CDC, 2021, June 13).5 There is also a serious public health threat from other vaccine-preventable diseases, such as measles and pertussis, as the rates of routine immunizations took a precipitous drop during the pandemic (Santoli, et al. 2020).6 The CDC is recommending that children receive all regularly scheduled vaccines, along with the COVID-19 vaccine (CDC, 2021 April 6).7

The Pfizer-BioNTech COVID-19 vaccine, which is an mRNA vaccine, recently received FDA approval for adolescents aged 12 through 15 years (USFDA, 2021, May 10).3 This vaccine is administered intramuscularly as a series of 2 doses (0.3 mL each) 3 weeks apart. The most common adverse effects are chills, fever, headache, joint and muscle pain, pain and redness at the injection site, and tiredness. Aside from pain at the injection site, more adolescents reported these adverse effects after the second dose than after the first dose, so it is important to advise adolescents and parents to expect that there may be some adverse effects after either dose but even more so after the second. The adverse effects in adolescents were consistent with those reported in clinical trial participants aged 16 years and older (USFDA, 2021, May 10).3

Pfizer also said that it plans to request authorization for BioNTech COVID vaccine use in children aged 2 through 11 years in September 2021 and for children younger than aged 2 years later in 2021 (Jenco, 2021, May 6).8

Recently, there have been reports of myocarditis and pericarditis following mRNA vaccines. These events occurred mostly in male adolescents and young adults aged 16 years and older. Myocarditis and pericarditis are seen more often after getting the second dose of either Moderna or Pfizer COVID-19 vaccines than after the first dose. The symptoms typically occur within 4 days after COVID-19 vaccination. As of press time, there have been 275 cases of either myocarditis or pericarditis of more than 600,000 doses administered to adolescents and children in the United States since Pfizer received its emergency use authorization on May 10, 2021 (CDC, 2021, May 18).9 Most patients who received care responded well to rest and treatment and quickly recovered. Patients can usually return to normal daily activities after their symptoms improve, and they should speak with health care providers about returning to exercise or sports. The CDC continues to monitor the situation and recommends COVID-19 vaccinations for everyone aged 12 years and older, given the greater risk of COVID-19 illness and related, possibly severe complications (CDC, 2021, May 27).10 Getting vaccinated is the best way to help protect individuals aged 12 years and older from COVID-19 illness and potential complications.

Another COVID-19 vaccine for adolescents is also moving toward approval. Moderna reported that its COVID-19 vaccine is 96% effective for adolescents aged 12 through 17 years after at least 1 dose and has no serious safety concerns (Jenco, 2021, May 6).8 The report did not provide additional details on a projected timeline for requesting FDA approval. Moderna is also continuing to study its vaccine in children aged 6 months to 11 years (Jenco, 2021, May 6).8

COVID-19 vaccines are becoming a reality for children. With the vaccines comes the return to birthday parties, in-classroom school, play dates, and sleepovers. But the COVID vaccine is not the only one children need. Routine vaccination is an essential preventive care service for adolescents, children, and adults, including pregnant women, that should not be delayed because of the COVID-19 pandemic. Parents have not been bringing their children into the offices of health care providers for well-child visits and vaccines. It is essential to assess the vaccination status of all adolescents and children at each patient visit to avoid missed opportunities for vaccination and ensure timely vaccine catch-up. All vaccines due or overdue should be administered according to the recommended CDC immunization schedules during each visit unless there is a specific contraindication. This will provide protection as soon as possible and minimize the number of health care visits needed to complete vaccination. Health care providers should identify children who have missed recommended vaccinations and/or well-child visits. Contact parents to schedule in-person appointments, starting with newborns, infants, and children up to aged 2 years, young children, and extending through adolescence. COVID-19 is still circulating, and cases among children can often be asymptomatic. Consequently, the importance of evidence-based infection prevention practices cannot be overemphasized for all patient encounters. These measures include hand and respiratory hygiene, physical distancing, source control, and surface decontamination (CDC, 2021, April 6).7

Because vaccine administration has decreased during the COVID-19 pandemic, under vaccinated or unvaccinated children are susceptible to preventable illness, such as measles, and communities are at risk for outbreaks. Strategies should be implemented to promote vaccination schedule adherence and ensure catch-up vaccination. Reminder and recall systems should be implemented to identify children who are due for or who have missed vaccine doses. Electronic health records and immunization information systems can be essential to tracking delinquent vaccine doses. In addition, the vaccination status of all children should be assessed at every health care visit to reduce missed opportunities for vaccination, including COVID-19 vaccination, and standing orders should be implemented (CDC, 2021, April 6).7

Health care providers who care for children must ensure that children receive not just COVID-19 vaccines but all age-appropriate vaccines that are due and catch up on any missed doses. It would be a travesty if children headed back to school without the vaccine-induced protection they need to stay healthy. Without all Advisory Committee on Immunization Practices (ACIP)-indicated vaccines, children could be headed back to school and out of the COVID-19 pandemic into a measles or pertussis epidemic.

1. Children and COVID-19: state data report. American Academy of Pediatrics. April 29, 2021. Accessed June 17, 2021. 

https://downloads.aap.org/AAP/PDF/AAP%20and%20CHA%20-%20Children%20and%20COVID-19%20State%20Data%20Report%204.29.21%20FINAL.pdf

2. Children and COVID-19: state data report. American Academy of Pediatrics. June 3, 2021. Accessed June 17, 2021. 

https://downloads.aap.org/AAP/PDF/AAP%20and%20CHA%20-%20Children%20and%20COVID-19%20State%20Data%20Report%206.3.21%20FINAL.pdf

3. United Stated Food and Drug Administration. (2021, May 10). Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic. Retrieved from 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use

4. Harris N. Will kids go back to school in the fall? Here’s what experts think and what it may look like. 

https://www.parents.com/kids/education/back-to-school/will-kids-go-back-to-school-in-the-fall-heres-what-experts-think-and-what-it-may-look-like/

5. Demographic characteristics of people receiving COVID-19 vaccinations in the United States. CDC. June 16, 2021. Accessed June 17, 2021. 

https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic

6. Santoli JM, Lindley MC, DeSilva MB, et al. Effects of the COVID-19 pandemic on routine pediatric vaccine ordering and administration — United States, 2020. 

 2020;69(19):591-593. doi:10.15585/mmwr.mm6919e2

7. Interim guidance for routine and influenza immunization services during the COVID-19 pandemic. CDC. April 6, 2021. Accessed June 17, 2021. 

https://www.cdc.gov/vaccines/pandemic-guidance/index.html

8. Jenco M. Moderna reports COVID-19 vaccine for teens safe, effective. 

https://www.aappublications.org/news/2021/05/06/moderna-covid-vaccine-teens-050621

9. Mendez R. CDC says 600,000 kids ages 12 to 15 have received Covid vaccine shots in last week. CDC. May 18, 2021. Accessed June 17, 2021. 

https://www.cnbc.com/2021/05/18/cdc-says-600000-kids-aged-12-to-15-have-received-covid-shots-in-last-week-.html

10. Myocarditis and pericarditis following mRNA COVID-19 vaccination. CDC. May 27, 2021. Accessed June 17, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html

Practitioners can help ensure that kids get these and all age-appropriate vaccinations before school starts in the fall.

COVID Vaccines for Children Are Becoming a Reality

interviewed Carrie Cuttler, an assistant professor in the Department of Psychology at Washington State University, on a recent study she co-authored that was published in the 

 on the use of cannabis in treating symptoms of obsessive-compulsive disorder (OCD).

 What are the implications of your research on the use of THC, CBD, and other compounds in cannabis, such as CBG or CBN, as potential treatments for OCD? Are there any potential benefits to one compound over another?

Yeah. So, we examined whether THC, CBD, or the interaction between THC and CBD might predict the size of the symptom reductions.

We found that as CBD increased, so did the size of the reduction in compulsions. That's actually consistent with a couple of previous animal studies that showed that CBD reduced compulsive behavior in rodents.

In contrast, THC and interactions between THC and CBD really did not predict the size of symptom reductions people reported.

So, these findings suggest that cannabis with higher concentrations of CBD may be more beneficial for managing compulsions. Well, inhaling really any cannabis product might produce perceived reductions in intrusions and anxiety.

Carrie Cuttler, PhD, an assistant professor in the Department of Psychology at Washington State University, on recent findings that show CBD may reduce intrusive thoughts and anxiety for patients with OCD.

CBD May Reduce Intrusive Thoughts, Anxiety for Patients With OCD

Columbia University School of Nursing (CUSN) in New York has established a research center on health care systems. The goal of the Center for Healthcare Delivery Research and Innovation (HDRI) is to expand access to high-quality, safe health care in the United States and around the world.

Lusine Poghosyan, PhD, MPH, RN, FAAN, was named executive director of the new center.

 Dr A CUSN professor, and professor of health policy and management at Columbia’s Mailman School of Public Health (MSPH), Poghosyan is an award-winning, internationally recognized research in health services. Her research background lies in primary care organizations, workforce, teamwork, and quality of patient care.

Other faculty and fellows affiliated with the center include scholars from CUSN, and MSPH, as well as ColumbiaDoctors, NewYork-Presbyterian Hospital, and other recognized institutions from the United States, Canada, Germany, and the United Kingdom. Additionally, HDRI is providing training for 5 PhD students and 2 postdoctoral fellows, who are studying care for high-cost, high-needs patients, and patients with dementia and multiple chronic conditions. These students and fellows are also training to provide delivery of mental health services in primary care and community health centers.

“Our research [at HDRI] focuses on how to build effective health-care teams—communities in their own right—to take care of patients in critical situations and how to improve work environments in health-care organizations to promote and support teamwork and ultimately patient care,” said Poghosyan, in a prepared statement issued by Columbia. “We also study how to optimally utilize the growing workforce of nurse practitioners (NPs) in primary care to ensure patients have access to timely, high-quality primary care.”

According to Poghosyan, This type of research is critical to expanding access to care.

“The demand for primary care services in the US is increasing exponentially, and the NP workforce, [which is] expected to almost double in near future, can help address this demand. But several barriers at the federal, state, and organizational level limit NPs’ ability to provide primary care. Our research seeks to identify these policies and barriers, particularly in how they relate to patient care and outcomes,” she added.

Investigators at HDRI are currently looking at racial disparities in care among people with dementia who receive care from NP practices

“Little is known about how to optimize primary care practices employing NPs, which often lack the organization and structure needed to ensure continuity of care and better outcomes for minority people with dementia,” Poghosyan said. “And there’s little guidance on how to improve access to community resources to help.”

The center’s research is intended to help answer questions about optimizing primary care practices employing NPs and guide policy changes to support the nursing workforce, according to Poghosyan.

Other projects underway include a program to train nurse scholars on comparative and cost-effectiveness research, and a study of social networks in medical homes and their impact on patient care and patient outcomes.

HDRI will also help investigators obtain research funding, and senior faculty will mentor and guide junior researchers as they develop their own research programs, giving them support needed for them to be successful at Columbia Nursing and obtain tenure.

“The spotlight has never shone brighter on nurses as leaders. HDRI will help build the evidence we need to support the nursing workforce, and nurses themselves, while expanding access to high-quality health care,” says Lorraine Frazier, PhD, the dean of Columbia University School of Nursing and the senior vice president of Columbia University Irving Medical Center, in a prepared statement.

Research at the center is currently funded by the National Institute of Nursing Research, the National Institute on Aging, the National Institutes of Health, the Agency for Healthcare Research and Quality, the Robert Wood Johnson Foundation, and the National Council of State Boards of Nursing, as well as other organizations.

Columbia University School of Nursing launches center for healthcare delivery research and innovation [news release]. May 20, 2021; Columbia School of Nursing. Accessed May 21, 2021. [email]

Lusine Poghosyan, PhD, MPH, RN, FAAN: Overview. Columbia School of Nursing. Accessed May 21, 2021. 

https://www.nursing.columbia.edu/profile/lusine-poghosyan-phd

The center was recently launched by Columbia School of Nursing.

New Research and Innovation Center Focuses on Health Services, Care Delivery

An analysis of randomized placebo-controlled trials suggests that the use of herbal and dietary supplements for weight loss cannot be justified based on the available evidence. Presented at the European Congress on Obesity, the analysis includes data from 121 trials with nearly 10,000 adult participants.

The findings indicate that although some herbal and dietary supplements show statistically greater weight loss than placebo, it is not enough to benefit health, according to the study authors. Further, the investigators call for more research into their long-term safety of these supplements.

“Over-the-counter herbal and dietary supplements promoted for weight loss are increasingly popular, but unlike pharmaceutical drugs, clinical evidence for their safety and effectiveness is not required before they hit the market”, said dietitian Erica Bessell, PhD candidate at the University of Sydney, in a press release. “Our rigorous assessment of the best available evidence finds that there is insufficient evidence to recommend these supplements for weight loss. Even though most supplements appear safe for short term consumption, they are not going to provide weight loss that is clinically meaningful.”

The researchers did a systematic review of 54 randomized trials comparing the effect of herbal supplements to placebo on weight loss up to August 2018, followed by a systematic review up to December 2019 of 67 randomized trials. Of the 14 supplements analyzed, only 4 resulted in a statistically significant increase in weight loss, and none resulted in clinically significant weight loss (5.5 lbs or greater).

Some dietary supplements, including modified cellulose—plant fibre that expands in the stomach to induce a feeling of fullness—and blood orange juice extract, showed promising results. However, these were only investigated in 1 trial and more evidence is required before recommending them for weight loss, according to the study authors.

“Herbal and dietary supplements might seem like a quick-fix solution to weight problems, but people need to be aware of how little we actually know about them,” Bessell said, in the press release. “Very few high-quality studies have been done on some supplements with little data on long-term effectiveness. What's more, many trials are small and poorly designed, and some don't report on the composition of the supplements being investigated. The tremendous growth in the industry and popularity of these products underscores the urgency for conducting larger, more rigorous studies to have reasonable assurance of their safety and effectiveness for weight loss.”

Most comprehensive studies to date find 'insufficient evidence' to support herbal and dietary supplements for weight loss [news release]. EurekAlert; May 8, 2021. Accessed May 10, 2021. 

https://www.eurekalert.org/pub_releases/2021-05/eaft-mcs050621.php

Presented at the European Congress on Obesity, the analysis includes data from 121 trials with nearly 10,000 adult participants.



Study Shows No Significant Evidence for the Efficacy of Herbal, Dietary Weight Loss Supplements

According to research selected for presentation at Digestive Disease Week 2021, combining minimally invasive endoscopic sleeve gastroplasty (ESG) with the diabetes drug semaglutide can provide additional significant weight loss for patients who are not candidates for invasive surgery.

"As the worldwide obesity rate continues to climb, so do the number of people seeking bariatric surgery to treat their condition," said Anna Carolina Hoff, MD, lead researcher on the study and founder and clinical director of Angioskope Brazil, São José dos Campos, in a press release. "Surgical procedures are some of the most successful ways to help patients lose weight, but they can eventually come with complications. Our study shows that patients may not have to undergo invasive surgery to get similar results."

In a double-blind study, researchers randomized 61 patients undergoing ESG into 2 groups with 1 group of 29 patients receiving semaglutide, an injectable glucagon-like peptide-1 receptor that has been found to stimulate weight loss, beginning 1 month after the procedure. Another group of 29 patients received a placebo administered with look-alike injector pens. Additionally, 3 patients were lost to follow-up and participants were monitored each month for body weight and body composition, with blood panels taken every 3 months, according to the press release.

Patients who received semaglutide lost an average of 26.7% of their total body weight compared to the control group, which lost an average of 19.6% of total body weight. The semaglutide group lost 86.3% of their excess weight, or the amount of weight the patients needed to lose to reach normal BMI, compared to 60.4% for the control group.

The semaglutide group also lost 12.7% of their body fat by weight compared to 9% for the control group. Further, glycated hemoglobin levels fell 0.95 for the semaglutide group and 0.61 for the controls.

Surgical procedures, such as laparoscopic sleeve gastrectomy, come with increased costs and a higher risk for complications, such as gastroesophageal reflux disease (GERD). These surgical procedures are typically limited to those with a BMI of at least 35 with comorbidities or with a BMI above 40.

ESG can be performed at an earlier stage of the disease and at a lower BMI, so more patients can get the treatment they need before their disease progresses. Additionally, treating patients with obesity earlier can help reduce death and comorbidities as well as reduce costs associated with treatments for these conditions, according to the study authors.

"ESG has been available to patients for years, but it has not always been as successful as surgical options in helping patients lose weight," Hoff said in the press release. "We now have a minimally invasive procedure that can be just as successful when combined with semaglutide and can be made available to even more people looking to lose a significant amount of weight."

ESG is performed by guiding a device through the patient’s throat and into the stomach, where an endoscopist uses sutures to make the stomach smaller. This helps patients lose weight by limiting the amount they can eat. Patients are candidates for ESG if they have a BMI at or above 30, diet and exercise have not helped them lose weight, or if they are not a candidate for surgery or do not wish to pursue surgery.

The researchers caution that long-term durability of the treatment still needs to be determined.

Pairing bariatric procedure with diabetes drug increases weight loss. EurekAlert! Published May 14, 2021. Accessed May 14, 2021. https://www.eurekalert.org/pub_releases/2021-05/ddw-pbp051221.php

Additionally, 3 patients were lost to follow-up and participants were monitored each month for body weight and body composition, with blood panels taken every 3 months.

Pairing Bariatric Procedure With Diabetes Drug Increases Weight Loss

A phase 3 trial investigating the PD-1 inhibitor cemiplimab (Libtayo, Regeneron) in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy showed a significant improvement in overall survival (OS), with a reduction in the risk of death by 31% compared to chemotherapy in the overall population, according to a presentation at the European Society for Medical Oncology Virtual Plenary.

These positive results add to the previously reported data showing an improvement in OS with cemiplimab compared to chemotherapy. In light of these positive findings, the data from this trial will be used as the basis for regulatory submissions in 2021.

"Improvements in progression-free survival [PFS] and objective response rate [ORR] were also demonstrated in the overall population compared to chemotherapy. Taken together, this landmark trial—which enrolled patients regardless of PD-L1 expression status—helps support the use of [cemiplimab] as a potential new second-line treatment for women with advanced cervical cancer who face a poor prognosis and limited treatment options," said trial investigator Krishnansu S. Tewari, MD, professor and director of the Division of Gynecologic Oncology at the University of California, Irvine, in a press release.

Currently, cervical cancer is the fourth leading cause of cancer mortality in women globally, with the most frequently diagnosed age group being women aged 35 to 44 years. Every year, approximately 570,000 women are diagnosed with cervical cancer, with deaths among those diagnosed totaling more than 250,000 annually. In the United States alone, there are approximately 14,500 patients diagnosed annually, with approximately 4000 women dying from the disease each year.

Although human papillomavirus infection is the cause of a majority of cases, approximately 80% are also classified as squamous cell carcinoma (SCC), which occurs from within cells in the lining at the bottom of the cervix. The remaining 20% of cases are classified as adenocarcinomas, which arises from glandular cells in the upper cervix. When detected early, cervical cancer is generally curable and can be managed; however, in advanced stages, the treatment options available become limited.

In the overall patient population, the investigators found that OS, PFS, and ORR significantly improved for those treated with cemiplimab (n=304), compared to chemotherapy (n=304). Specifically, the investigators observed a 31% reduction in mortality risk (hazard ratio [HR]: 0.69; 95% confidence interval [CI]: 0.56-0.84; one-sided p=0.00011), a 25% reduction in disease progression risk (HR: 0.75; 95% CI: 0.63-0.89; one-sided p=0.00048), and 16% ORR (50 patients; 95% CI: 13-21%; one-sided p=0.00004), compared to 6% with chemotherapy (19 patients).

Among this population, the median duration of response was 16 months with cemiplimab (95% CI: 12 months to not yet evaluable) and 7 months with chemotherapy (95% CI: 5-8 months), per Kaplan-Meier estimates.

Seventy-eight percent of trial participants were found to have advanced cervical cancer classified as SCC and also went on to experience significant improvements following treatment with cemiplimab (n=239) versus chemotherapy (n=238).

Specifically, patients in this population experienced a 27% reduction in mortality risk (HR: 0.73; 95% CI: 0.58-0.91; one-sided p=0.00306), a 29% reduction in disease progression risk (HR: 0.71; 95% CI: 0.58-0.86; one-sided p=0.00026), and 18% ORR (42 patients; 95% CI: 13-23%) compared to 7% with chemotherapy (16 patients; 95% CI: 4-11%).

Although the investigators did not set the assessment of adenocarcinoma as a pre-specified endpoint, a post-hoc analysis demonstrated that patients treated with cemiplimab (n=65) compared to chemotherapy (n=66) experienced a 44% reduction in mortality risk (HR: 0.56; 95% CI: 0.36-0.85; nominal one-sided p<0.005), a 9% reduction in disease progression risk (HR: 0.91; 95% CI: 0.62-1.34), and 12% ORR (8 patients; 95% CI: 6-23%), compared to 5% with chemotherapy (3 patients; 95% CI: 1-13%).

Additionally, the phase 3 trial demonstrated that patients treated with cemiplimab experienced an improvement or maintenance of their baseline Global Health Status/Quality of Life (GHS/QOL) over time. However, patients treated with chemotherapy experienced a deterioration that was clinically significant by cycle 8, per the European Organisation for Research and Treatment of Cancer QLQ-C30 (overall estimated mean change [95% CI]: improvement of 1.01 [-2.033, 4.047] for Libtayo, worsening of -6.81 [-10.977, -2.637] for chemotherapy; difference: 7.81; one-sided nominal p=0.00040).

The investigators observed no safety signals for patients treated with cemiplimab. The investigators had assessed safety in patients who received at least 1 dose of study treatment, which included 300 patients in the cemiplimab group (median duration of exposure: 15 weeks; range: 1-101 weeks) and 290 patients in the chemotherapy group (median duration of exposure: 10 weeks; range: 1-82 weeks).

In terms of adverse events (AEs) observed during the trial, investigators found 88% of cemiplimab patients and 91% of chemotherapy patients experienced AEs. In 15% or more of cemiplimab patients, AEs included anemia (25% cemiplimab, 45% chemotherapy), nausea (18% cemiplimab, 33% chemotherapy), fatigue (17% cemiplimab, 16% chemotherapy), vomiting (16% cemiplimab, 23% chemotherapy), decreased appetite (15% cemiplimab, 16% chemotherapy), and constipation (15% cemiplimab, 20% chemotherapy).

Additionally, grade 3 or higher AEs were observed in 45% of cemiplimab patients and 53% of chemotherapy patients, whereas in 15% or more of patients, certain grade 3 or higher AEs were observed more frequently in the cemiplimab group. These AEs included asthenia (2% cemiplimab, 1% chemotherapy) and pyrexia (less than 1% cemiplimab, 0% chemotherapy).

The investigators also observed immune-related AEs in 16% of cemiplimab patients and fewer than 1% of chemotherapy patients. The AEs at grade 3 or higher occurred in 6% of cemiplimab patients and fewer than 1% of chemotherapy patients. However, patients discontinuing treatment due to AEs only occurred among 8% of cemiplimab patients and 5% of chemotherapy patients.

Positive Phase 3 Libtayo® (cemiplimab) Results in Advanced Cervical Cancer Presented at ESMO Virtual Plenary. Tarrytown, NY: Regeneron Pharmaceuticals; May 12, 2021. 

https://investor.regeneron.com/news-releases/news-release-details/positive-phase-3-libtayor-cemiplimab-results-advanced-cervical

A phase 3 trial investigating the PD-1 inhibitor cemiplimab in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy showed a significant improvement in overall survival.

Positive Results for the Treatment of Advanced Cervical Cancer 

interviewed Lea Davis, PhD, an associate professor of medicine in the Department of Medicine at Vanderbilt University Medical Center and an investigator in the Vanderbilt Genetics Institute, on a recent study she co-authored that was published in 

During the interview, Davis discussed the findings of her research in relation to the epidemiology of functional seizures.

Lea Davis, PhD, an associate professor of medicine in the Department of Medicine at Vanderbilt University Medical Center and an investigator in the Vanderbilt Genetics Institute, discussed the epidemiology of functional seizures.

Understanding the Epidemiology of Functional Seizures

Individuals who are fully vaccinated against COVID-19 can resume activities they were doing prior to the pandemic, according to updated guidance from the CDC. The agency also advised that fully vaccinated individuals can resume many activities without wearing a mask or social distancing.

The CDC considers individuals in the United States to be fully vaccinated 2 weeks after receiving their second of a 2-dose Moderna or Pfizer-BioNTech vaccine series, or 2 weeks after receiving a single-dose Johnson & Johnson vaccine.

According to the CDC, outdoor activities deemed safest for fully vaccinated people, but less safe for unvaccinated individuals, include:

dining with friends from multiple households

attending crowded events, such as a live performance, parade, or sporting event

Some examples of indoor activities considered safest by the CDC for fully vaccinated individuals that are less safe for unvaccinated peers include:

going to an uncrowded shopping center or museum

attending a small gathering of people from multiple households, whether fully vaccinated or not

attending a full-capacity worship service or singing with a chorus

participating in a high-intensity exercise activity

In the updated guidance released today, the CDC cautioned that masks and social distancing may still be required of fully vaccinated individuals in adherence to federal, state, local, tribal, and territorial laws, rules, and regulations, as well as policies put into place by businesses and workplaces.

The agency is advising that all travelers, regardless of vaccination status, will still need to wear a mask when using public forms of transportation, including planes, buses, and trains. They should also continue to practice social distancing and frequent hand washing or use of hand sanitizer while traveling.3 However, fully vaccinated individuals do not need COVID-19 testing before or after traveling, nor do they need to quarantine upon arrival at a destination in the United States.

Individuals who are fully vaccinated should continue paying close attention to policies and COVID-19 situations at international destinations prior to making the trip. International travelers still need to provide a negative test result for COVID-19 or documentation of recovery from the virus prior to boarding international flights, regardless of vaccination status. The CDC also advises international travelers to obtain testing for COVID-19 within 3 days upon return to the United States, but these fully vaccinated individuals do not need to self-quarantine.

CDC guidance advises individuals who are not fully vaccinated to delay taking trips, if possible, until they are fully vaccinated. Those who do travel are advised to take a viral COVID-19 test 1 to 3 days prior to taking the trip and get tested again 3 to 5 days after returning home, as well as self-quarantining for a full 7 days.

When you’ve been fully vaccinated. CDC. Updated May 13, 2021. Accessed May 13, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html

Choosing safer activities. CDC. Updated May 13, 2021. Accessed May 13, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/participate-in-activities.html

Domestic travel during COVID-19. CDC. Updated April 27, 2021. Accessed May 13, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/travelers/travel-during-covid19.html

The CDC considers individuals in the United States to be fully vaccinated 2 weeks after receiving a complete series of COVID-19 vaccine doses.

CDC Says Fully Vaccinated Individuals can Resume Activities Without a Mask

During National Women’s Health Week, which takes place from May 9 to May 15, CVS Health announced new initiatives to further support women’s health and wellness during the month of May.

“Through our new initiatives to support women’s health and wellness in May, we aim to use our unmatched community presence and our diversified model to meet women where they are to help make preventative care more convenient and accessible for women,” said Eileen Howard Boone, senior vice president, corporate social responsibility & philanthropy and chief sustainability officer for CVS Health, in an interview with 

An example of an initiative CVS Health is doing is the 1100 MinuteClinic locations that are promoting a no-cost heart health screening program called “Know Your Numbers.” Patients will learn 5 key personal health numbers that can help them determine their risk for heart disease, including cholesterol, high-density lipoprotein (good) cholesterol, blood pressure, blood sugar, and body mass index.

“We know that nearly 80% of cardiac events can be prevented, yet many women don't have the awareness about this disease to understand and prevent their risk. That's why offering these free heart health screenings is so important, especially this year when so many people have put off preventative care,” Boone said.

In addition, CVS Pharmacy locations nationwide will raise funds to support the Go Red for Women movement. From now until May 29, customers can support the movement by making a donation at check-out or online at 

Mental and physical health has become more crucial than ever before since the start of the COVID-19 pandemic. Through the ExtraCare Rewards program, members will receive deals on women’s wellness items in-store, including weekly promotions on products such as vitamins and skin care, as well as feminine care and beauty products, until May 22.

“Given all of the responsibilities women have taken on, it can be difficult to find time to prioritize health and wellness. During National Women’s Health Week, we hope that women learn that although it’s been hard to prioritize preventative care during the pandemic, it’s essential for women to find the time to take care of themselves,” Boone told 

CVS Health announces new initiatives to support women’s health and wellness in May. CVS Health. Published May 3, 2021. Accessed May 13, 2021. 

https://cvshealth.com/news-and-insights/press-releases/cvs-health-announces-new-initiatives-to-support-womens-health-and

CVS Health Announces New Initiatives to Support Women's Health and Wellness in May

Contemporary Clinic spoke with Patricia Ryan Krause, MS, RN, MSN, PNP-BC, from the National Association of Pediatric Nurse Practitioners (NAPNAP) about Global Health Awareness Month 2021, which takes place in May.

This second part of the interview covers how to work with refugees with chronic conditions, any special considerations while working with those who experienced trauma while/before/after immigrating, and what she hopes to see for the future of patients who are impacted by health inequalities.

Special Considerations and Helping Patients with Health Inequalities

Because several pharmaceutical companies pulled back from the federal 340B program last fall, many patients with diabetes are now seeing skyrocketing insulin prices, according to Anne Webster, NP, with UnityPoint Health.

Webster said she has been forced to prescribe less effective insulin options in recent months and has seen patients beginning to ration their medications. In addition to impacting their physical health, Webster said she has seen patients struggling with their mental and financial wellbeing over the last few months, and she sees no end in sight. The only solution, she said, is for Health and Human Services Director Xavier Becerra, JD, to enforce federal policies to ensure affordable medication access.

Because several pharmaceutical companies pulled back from the federal 340B program last fall, many patients with diabetes are now seeing skyrocketing insulin prices.

News

All Content