December 5, 2023 Issue of JAMA

December 5, 2023, Vol 330, No. 21, Pages 2037-2128

This Week in JAMA

Audio Highlights

Abstract Full Text

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JAMA. 2023;330(21):e2216142. doi:10.1001/jama.2022.16142

Podcast: Sintilimab for Gastric Cancer, Lepodisiran Targeting Lipoprotein(a), CONSORT Extension for Factorial Trials, and more

Original Investigation

Sintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer: The ORIENT-16 Randomized Clinical Trial

Jianming Xu, MD; Haiping Jiang, MD; Yueyin Pan, PhD; et al.

Abstract Full Text

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JAMA. 2023;330(21):2064-2074. doi:10.1001/jama.2023.19918

This randomized clinical trial evaluates whether sintilimab plus chemotherapy vs placebo plus chemotherapy improved overall survival in patients in China with unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma.

Lepodisiran, an Extended-Duration Short Interfering RNA Targeting Lipoprotein(a): A Randomized Dose-Ascending Clinical Trial

Steven E. Nissen, MD; Helle Linnebjerg, PhD; Xi Shen, PhD; et al.

Abstract Full Text

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JAMA. 2023;330(21):2075-2083. doi:10.1001/jama.2023.21835

This randomized clinical trial compares a single dose of lepodisiran vs placebo to assess the safety, tolerability, pharmacokinetics, and effects on lipoprotein(a) concentrations in adults without cardiovascular disease and with lipoprotein(a) serum concentrations of 75 nmol/L or greater at baseline.

Adenotonsillectomy for Snoring and Mild Sleep Apnea in Children: A Randomized Clinical Trial

Susan Redline, MD, MPH; Kaitlyn Cook, PhD; Ronald D. Chervin, MD, MS; et al.

Abstract Full Text

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JAMA. 2023;330(21):2084-2095. doi:10.1001/jama.2023.22114

This randomized clinical trial evaluates whether early adenotonsillectomy, compared with watchful waiting and supportive care, improves neurodevelopmental, behavioral, health, and polysomnographic outcomes in US children with mild sleep-disordered breathing.

Editorial
Adenotonsillectomy or Watchful Waiting for Pediatric Sleep-Disordered Breathing
Inbal Hazkani, MD; Kathleen R. Billings, MD; Dana M. Thompson, MD, MS, MBA

JAMA
Invited Commentary
Adenotonsillectomy for Treatment of Mild Sleep-Disordered Breathing in Children
Norman R. Friedman, MD

JAMA Otolaryngol Head Neck Surg

Neonatal Survival After Serial Amnioinfusions for Bilateral Renal Agenesis: The Renal Anhydramnios Fetal Therapy Trial

Jena L. Miller, MD; Ahmet A. Baschat, MD; Mara Rosner, MD, MPH; et al.

Abstract Full Text

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JAMA. 2023;330(21):2096-2105. doi:10.1001/jama.2023.21153

This prospective, nonrandomized clinical trial assesses neonatal outcomes after serial amnioinfusions initiated before 26 weeks鈥� gestation to mitigate lethal pulmonary hypoplasia in pregnancies complicated by bilateral renal agenesis.

Podcast: Neonatal Outcomes Following Serial Amnioinfusions for Bilateral Renal Agenesis

Editorial
Bilateral Renal Agenesis鈥擨nterpreting the RAFT Trial
Cynthia Gyamfi-Bannerman, MD, MS; Krishelle Marc-Aurele, MD; Karen Mestan, MD, MS

JAMA

Research Letter

Ancillary Product Patents to Extend Biologic Patent Life

Rachel Goode, PhD; William B. Feldman, MD, DPhil, MPH; S. Sean Tu, JD, PhD

Abstract Full Text

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JAMA. 2023;330(21):2117-2119. doi:10.1001/jama.2023.19547

This study examines all patents associated with biologic litigation to understand how manufacturers use ancillary product patents to delay biosimilar market entry.

Inequitable Conduct and Invalidation of Patents Related to Food and Drug Administration鈥揜egulated Products

S. Sean Tu, JD, PhD; Caroline Leadmon, JD; C. Joseph Ross Daval, JD; et al.

Abstract Full Text

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JAMA. 2023;330(21):2119-2121. doi:10.1001/jama.2023.20196

This study examines the frequency of drug patent invalidations based on inequitable conduct.

Special Communication

Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement

Brennan C. Kahan, PhD; Sophie S. Hall, PhD; Elaine M. Beller, MAppStat; et al.

Abstract Full Text

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JAMA. 2023;330(21):2106-2114. doi:10.1001/jama.2023.19793

This article provides an extension of the Consolidated Standards of Reporting Trials 2010 checklist for the reporting of factorial trials.

Viewpoint

Explaining the Fifth Circuit Court of Appeals Ruling on Mifepristone Access

Molly A. Meegan, JD

Abstract Full Text

JAMA. 2023;330(21):2047-2048. doi:10.1001/jama.2023.21591

This Viewpoint summarizes the Fifth Circuit Court of Appeals ruling on access to mifepristone, the first of 2 pills used in medication abortion.

The Genetic Information Privacy Act: Drawbacks and Limitations

Anya E. R. Prince, JD, MPP

Abstract Full Text

JAMA. 2023;330(21):2049-2050. doi:10.1001/jama.2023.22345

This Viewpoint discusses proposed and enacted state legislation to protect genetic privacy for those participating in direct-to-consumer genetic testing and ensuring genetic antidiscrimination for life, health, long-term care, and disability insurance.

Rising From Ruin鈥擱evitalizing Native Hawaiian Health

Kekoa Taparra, MD, PhD; Nikki Kalani Apana, BA

Abstract Full Text

JAMA. 2023;330(21):2051-2052. doi:10.1001/jama.2023.21427

This Viewpoint offers insight into the health effects of the recent fires in Hawai驶i and what culturally conscious approaches are needed to ensure the health of Native Hawaiians going forward.

American Indian and Alaska Native Life Expectancy: Writing a New Narrative

Tassy Parker, PhD, RN; Allyson Kelley, DrPH

Abstract Full Text

JAMA. 2023;330(21):2053-2054. doi:10.1001/jama.2023.22614

This Viewpoint examines disparities and inequalities regarding life expectancy in American Indian and Alaska Native populations and what can be done to address them.

A Piece of My Mind

We Grieve Too

Mallory R. Taylor, MD, MS

Abstract Full Text

JAMA. 2023;330(21):2055-2056. doi:10.1001/jama.2023.23193

In this narrative medicine essay, a pediatric oncologist grapples with the emotions of loss and guilt while attending the memorial service of her 8-year-old patient.

Editorial

Adenotonsillectomy or Watchful Waiting for Pediatric Sleep-Disordered Breathing

Inbal Hazkani, MD; Kathleen R. Billings, MD; Dana M. Thompson, MD, MS, MBA

Abstract Full Text

JAMA. 2023;330(21):2057-2058. doi:10.1001/jama.2023.22373

Bilateral Renal Agenesis鈥擨nterpreting the RAFT Trial

Cynthia Gyamfi-Bannerman, MD, MS; Krishelle Marc-Aurele, MD; Karen Mestan, MD, MS

Abstract Full Text

JAMA. 2023;330(21):2059-2060. doi:10.1001/jama.2023.22747

AI in Medicine

The Future of Clinical Trials: Artificial to Augmented to Applied Intelligence

Adrian F. Hernandez, MD, MHS; Christopher J. Lindsell, PhD

Abstract Full Text

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JAMA. 2023;330(21):2061-2063. doi:10.1001/jama.2023.23822

Editorial
Innovation in Event Adjudication鈥擧uman vs Machine
Kenneth W. Mahaffey, MD; C. Michael Gibson, MS, MD; Renato D. Lopes, MD, MHS, PhD

JAMA Cardiol

JAMA Insights

Women's Health

Cardiovascular Health in the Postpartum Period

Sadiya S. Khan, MD, MSc; William A. Grobman, MD, MBA; Natalie A. Cameron, MD, MPH

Abstract Full Text

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JAMA. 2023;330(21):2115-2116. doi:10.1001/jama.2023.19192

This article in the Women鈥檚 Health series discusses recent increases in US maternal death rates, disparities in rates by race and ethnicity, poor cardiovascular health (CVH) as one of the multifactorial causes, and clinical approaches to assessing and treating poor CVH postpartum.

Podcast: Improving Cardiovascular Health During the Postpartum Period

Medical News & Perspectives

Highlights From IDWeek 2023鈥擭ew Vaccines, Artificial Intelligence, and Antimicrobial Resistance

Preeti Malani, MD, MSJ

Abstract Full Text

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JAMA. 2023;330(21):2040-2041. doi:10.1001/jama.2023.19291

This Medical News article is an interview with infectious disease physician Heather Yun, MD, cochair of this year鈥檚 Infectious Diseases Week meeting in Boston.

Podcast: Highlights From Infectious Diseases Week 2023

Quick Uptakes

Here鈥檚 What to Know About Cardiovascular-Kidney-Metabolic Syndrome, Newly Defined by the AHA

Howard Larkin

Abstract Full Text

JAMA. 2023;330(21):2042-2043. doi:10.1001/jama.2023.22276

This Medical News article discusses a recent American Heart Association presidential advisory on CKM syndrome that lays the groundwork for a new cardiovascular disease risk calculator.

Medical News in Brief