JAMA

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Effect of an Active vs Expectant Management Strategy on Successful Resolution of Pregnancy Among Patients With a Persisting Pregnancy of Unknown Location

Kurt T. Barnhart, MD1; Karl R. Hansen, MD2; Mary D. Stephenson, MD3; Rebecca Usadi, MD4; Anne Z. Steiner, MD5; Marcelle I. Cedars, MD6; Emily S. Jungheim, MD7; Kathleen M. Hoeger, MD8; Stephen A. Krawetz, PhD9; Benjie Mills, MD10; Meredith Alston, MD11; Christos Coutifaris, MD1; Suneeta Senapati, MD1; Sarita Sonalkar, MD1; Michael P. Diamond, MD12; Robert A. Wild, MD2; Mitchell Rosen, MD6; Mary D. Sammel, ScD13; Nanette Santoro, MD14; Esther Eisenberg, MD15; Hao Huang, MD16; Heping Zhang, PhD16; for the Reproductive Medicine Network

doi : 10.1001/jama.2021.10767

JAMA. 2021;326(5):390-400

Women with an early nonviable pregnancy of unknown location are at high risk of ectopic pregnancy and its inherent morbidity and mortality. Successful and timely resolution of the gestation, while minimizing unscheduled interventions, are important priorities.

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Effect of a Sedation and Ventilator Liberation Protocol vs Usual Care on Duration of Invasive Mechanical Ventilation in Pediatric Intensive Care Units

Bronagh Blackwood, PhD1; Lyvonne N. Tume, PhD2,3; Kevin P. Morris, MD4,5; Mike Clarke, DPhil6; Clíona McDowell, MSc7; Karla Hemming, PhD8; Mark J. Peters, PhD9,10; Lisa McIlmurray, MPhil1; Joanne Jordan, DPhil1; Ashley Agus, PhD7; Margaret Murray, PhD7; Roger Parslow, PhD11; Timothy S. Walsh, MD12; Duncan Macrae, MB13; Christina Easter, MSc8; Richard G. Feltbower, PhD11; Daniel F. McAuley, MD1; for the SANDWICH Collaborators

doi : 10.1001/jama.2021.10296

JAMA. 2021;326(5):401-410

There is limited evidence on the optimal strategy for liberating infants and children from invasive mechanical ventilation in the pediatric intensive care unit.

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Association of Dose Tapering With Overdose or Mental Health Crisis Among Patients Prescribed Long-term Opioids

Alicia Agnoli, MD, MPH, MHS1,2; Guibo Xing, PhD2; Daniel J. Tancredi, PhD2,3; Elizabeth Magnan, MD, PhD1,2; Anthony Jerant, MD1,2; Joshua J. Fenton, MD, MPH1,2,4

doi : 10.1001/jama.2021.11013

JAMA. 2021;326(5):411-419

Opioid-related mortality and national prescribing guidelines have led to tapering of doses among patients prescribed long-term opioid therapy for chronic pain. There is limited information about risks related to tapering, including overdose and mental health crisis.

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Association Between Hospital Voluntary Participation, Mandatory Participation, or Nonparticipation in Bundled Payments and Medicare Episodic Spending for Hip and Knee Replacements

Joshua M. Liao, MD, MSc1; Atul Gupta, PhD2; Yueming Zhao, MPH3; Jingsan Zhu, MS3; Joseph Martinez, BS2; Deborah S. Cousins, MSPH3; Amol S. Navathe, MD, PhD3

doi : 10.1001/jama.2021.10046

JAMA. 2021;326(5):438-440

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FDA Regulation and Approval of Medical Devices: 1976-2020

Jonathan J. Darrow, SJD, LLM, JD, MBA1; Jerry Avorn, MD1; Aaron S. Kesselheim, MD, JD, MPH1

doi : 10.1001/jama.2021.11171

JAMA. 2021;326(5):420-432

US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation.

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