1. Risks of removing ovaries at benign hysterectomy may outweigh the benefits for women at low risk for ovarian cancer
Findings support current recommendations for conserving ovaries in premenopausal patients
Abstract: https://www.acpjournals.org/doi/10.7326/M22-1628
Editorial: https://www.acpjournals.org/doi/10.7326/M23-0756
Patient Summary: https://www.acpjournals.org/doi/10.7326/P23-0001
URL goes live when the embargo lifts
An emulated target trial of more than 140,000 women in Denmark found that removing the ovaries at benign hysterectomy was associated with increased risk for cardiovascular disease in younger women and cancer in older women at low risk for ovarian cancer. These findings support current recommendations for preserving ovaries in premenopausal patients. The findings are published in Annals of Internal Medicine.
Removal of the ovaries decreases the risk for ovarian cancer and greatly benefits the survival of women at high risk for ovarian cancer. However, not enough is known about how removal of the ovaries affects other possible outcomes, such as heart attack, stroke, other types of cancer, and how long patients live.
Researchers from the Danish Cancer Society Research Center, Copenhagen, Denmark studied health records for 142,985 women who underwent a benign hysterectomy with or without bilateral salpingo-oophorectomy (removal of the ovaries and fallopian tubes) to compare long-term outcomes. The researchers found that women who had their ovaries removed had a lower risk of ovarian cancer, but other health outcomes varied by age/menopause status. Premenopausal women who had ovaries removed had a higher risk of hospitalization for cardiovascular disease. Perimenopausal, early postmenopausal, and late postmenopausal women who had ovaries removed had a higher risk for cancer. The authors noted that women who had their ovaries removed at perimenopausal ages had more deaths when measured at 10 and 20 years after surgery, but women aged 65 years or older had fewer deaths when measured at 20 years after surgery. According to the authors, these results suggest a cautious approach to removing ovaries in women at low risk for ovarian cancer.
An accompanying editorial by authors from the University of Health San Antonio and Wayne State University School of Medicine highlights the complex factors that must be considered when deciding to recommend BSO. They note that the recent practice of opportunistic salpingectomy can offer reduced ovarian cancer rates without compromising ovarian function, and data shows that the use of hormone replacement will mitigate risk rely on patients’ adherence to medication. The authors emphasize that based on available evidence and guidelines, the decision for BSO is best left to shared decision making between patient and physician.
Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org . To speak with the first author Mathilde Gottschau, MD, PhD, please send email to Mette Weber at mvw@CANCER.DK .
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2. Amubarvimab/romlusevimab reduces hospitalization and death by 79% in adults diagnosed with COVID-19
Abstract: https://www.acpjournals.org/doi/10.7326/M22-3428
URL goes live when the embargo lifts
A randomized controlled trial of more than 800 adults diagnosed with COVID-19 found that combination therapy with amubarvimab plus romlusevimab significantly reduced the rates of hospitalization and death compared to placebo. The clinical benefit was similar regardless of whether therapy was given within 5 days or more than 5 days of symptom onset. The findings are published in Annals of Internal Medicine.
As COVID-19 evolves, the development of safe and effective therapeutics is a high priority. Amubarvimab and romlusevimab are non-competing anti-SARS-CoV-2 monoclonal antibodies with an extended half-life that may be an effective and safe option for persons who are at high risk of clinical progression to severe COVID-19.
ACTIV-2/A5401 is a multinational, adaptive platform treatment trial designed to evaluate the safety and efficacy of investigational agents for the treatment of nonhospitalized adults with COVID-19. In the study of amubarvimab and romlusevimab, researchers randomly assigned 807 persons with symptomatic COVID-19 infection who were at high risk of clinical progression to be treated with either amubarvimab plus romlusevimab or placebo to assess the regimen’s safety and efficacy. Half of all participants received combination therapy with amubarvimab plus romlusevimab and the other half received placebo. The authors observed a 79 percent reduction in progression to hospitalization and death for persons receiving the active therapy. They also found that hospitalization and death occurred in only 2.3 percent of participants who received amubarvimab plus romlusevimab compared to 10.7 percent of participants who received placebo. Adverse events were observed in 7.3 percent of persons receiving amubarvimab plus romlusevimab compared with 16.1 percent of persons receiving placebo. However, the authors advise that these medications' utility is likely to be limited for currently circulating COVID-19 subvariants.
Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org . To speak with corresponding author Eric S. Daar, MD, at the Lundquist Institute at Harbor-UCA Medical Center, please email Max Benavidez at max.benavidez@lundquist.org .
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3. Combination therapy with oral fluvoxamine and inhaled budesonide significantly reduces risk for severe COVID-19 in outpatients at high risk for disease progression
Abstract: https://www.acpjournals.org/doi/10.7326/M22-3305
URL goes live when the embargo lifts
A randomized controlled trial found that treatment with oral fluvoxamine plus inhaled budesonide among high-risk outpatients with early COVID-19 reduced the incidence of severe disease requiring advanced care. Previous studies evaluated these drugs independently. The combined effect seems to offer benefits over individual use of each drug. The findings are published in Annals of Internal Medicine.
Researchers for the TOGETHER trial, a randomized adaptive platform trial to investigate the efficacy of repurposed treatments, conducted the trial with 738 symptomatic adults with confirmed SARS-CoV-2 infection residing in a highly vaccinated population. All patients had known risk factors for progression to severe disease. The investigators randomly assigned participants to either fluvoxamine (100 mg twice daily for 10 days) plus inhaled budesonide (800 mcg twice daily for 10 days) or matching placebos over 28 days and monitored for hospitalization and/or clinical progression. They found that administration of the drug combination significantly reduced the rate of COVID-19 progression resulting in prolonged observation in an emergency setting or hospitalization.
The study authors note that theirs is among the first to evaluate a drug combination for treatment of ambulatory patients with COVID-19 in a randomized trial. A difference from prior trials is that Their trial was conducted in a population that was approximately 95% vaccinated. Given the safety, tolerability, ease of use, low cost, and widespread availability of these drugs, the researchers suggest that their findings may be useful for clinicians worldwide who are considering treating outpatients.
Media contacts : For an embargoed PDF, please contact Angela Collom at acollom@acponline.org . To speak with corresponding author Gilmar Reis, MD, PhD, email greis@cardresearch.org . Second corresponding author, Edward Mills, PhD, can be reached at millsej@mcmaster.ca .
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4. ACP calls for appropriate and meaningful measures to evaluate telemedicine
Abstract: https://www.acpjournals.org/doi/10.7326/M23-0140
URL goes live when the embargo lifts
As the amount of health care services provided to patients using telemedicine increases, physicians must ensure the quality of the performance measures being used to evaluate that care, says the American College of Physicians (ACP) in a new policy paper. The paper details new recommendations to ensure that as measures are developed to gauge telemedicine services they are evidence-based, methodologically sound and clinically meaningful. The paper is published in Annals of Internal Medicine.
ACP’s paper focuses on telemedicine services provided in an ambulatory care environment, including via interactive audio and video telecommunications systems. ACP recommends that any performance measure used to evaluate telemedicine visits should adhere to the same criteria as in-person visits, and that existing measures for in-person visits should be evaluated to see whether it would be appropriate to also include telemedicine visits. ACP also cautions that telemedicine visits need to be incorporated into electronic health records systems, so that those visits do not become standalone encounters further fragmenting care delivery. The paper strongly recommends that measures must be tested to show that they are reliable and valid for the telemedicine environment, as well as attributed at the appropriate level, whether that’s to an individual physician, group practice, health system or health plan. Lastly, ACP recommends that measures should be used to evaluate the impact of telemedicine on under-resourced communities to ensure that access and quality of care are not harmed in communities that lack digital access.
Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org . To speak with ACP president, Ryan Mire, MD, MPH, please contact Jaquelyn Blaser at jblaser@acponline.org .
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Also new in this issue:
The New European Medical Device Regulation – Balancing Innovation and Patient Safety
Michael Bretthauer MD PhD1,2, Sara Gerke Dipl-Jur Univ MA3, Cesare Hassan MD PhD4,5, Omer F. Ahmad BSc MD6, Yuichi Mori MD PhD
Medicine and Public Issues
Abstract: https://www.acpjournals.org/doi/10.7326/M23-0454
Universal Masking in Healthcare Settings: A Pandemic Strategy Whose Time Has Come, and Gone, For Now
Erica S. Shenoy, MD, PhD; Hilary M. Babcock, MD, MPH5; Karen B. Brust, MD; Michael S. Calderwood, MD, MPH; Shira Doron, MD; Anurag N. Malani, MD; Sharon B. Wright, MD, MPH; Westyn Branch-Elliman, MD, MMSc
Ideas and Opinions
Abstract: https://www.acpjournals.org/doi/10.7326/M23-0793
Annals of Internal Medicine
Observational study
People
Long-Term Health Consequences After Ovarian Removal at Benign Hysterectomy
18-Apr-2023