August 15, 2017 Issue of JAMA

August 15, 2017, Vol 318, No. 7, Pages 587-676

This Week in JAMA

Highlights

Abstract Full Text

free access has audio

JAMA. 2017;318(7):587-589. doi:10.1001/jama.2016.13267

Podcast: FDA High-Risk and Accelerated Approvals, Review of Celiac and Nonceliac Gluten Sensitivity, and more

Original Investigation

Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements

Sarah Y. Zheng, MD; Sanket S. Dhruva, MD, MHS; Rita F. Redberg, MD, MSc

Abstract Full Text

free access has audio

JAMA. 2017;318(7):619-625. doi:10.1001/jama.2017.9414

This study characterizes the quality of clinical studies and data used to support US Food and Drug Administration approval of modifications to high-risk medical devices.

Podcast: Are they safe? Drugs and devices receiving accelerated approval by the FDA

Editorial
Balancing the Need for Access With the Imperative for Empirical Evidence of Benefit and Risk
Robert M. Califf, MD

JAMA
- Podcast: Are they safe? Drugs and devices receiving accelerated approval by the FDA

Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration

Huseyin Naci, PhD, MHS; Katelyn R. Smalley, BSc; Aaron S. Kesselheim, MD, JD, MPH

Abstract Full Text

free access has audio

JAMA. 2017;318(7):626-636. doi:10.1001/jama.2017.9415

This study uses public US Food and Drug Administration (FDA) data to characterize drug trials used to obtain FDA accelerated approval and to describe the existence, timing, and characteristics of postapproval trials mandated by the FDA as part of the accelerated approval decision.

Podcast: Are they safe? Drugs and devices receiving accelerated approval by the FDA

Editorial
Balancing the Need for Access With the Imperative for Empirical Evidence of Benefit and Risk
Robert M. Califf, MD

JAMA
- Podcast: Are they safe? Drugs and devices receiving accelerated approval by the FDA

Preliminary Communication

Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial

Mette Yun Johansen, MSc; Christopher Scott MacDonald, MSc; Katrine Bagge Hansen, MD, PhD; et al.

Abstract Full Text

free access

JAMA. 2017;318(7):637-646. doi:10.1001/jama.2017.10169

This randomized clinical trial compared the effects of an intensive lifestyle intervention vs standard care on glycemic control and medication reduction among participants with non鈥搃nsulin-dependent type 2 diabetes.

Research Letter

Public Response to a Proposed Field Trial of Genetically Engineered Mosquitoes in the United States

Cinnamon S. Bloss, PhD; Justin Stoler, PhD, MPH; Kimberly C. Brouwer, PhD; et al.

Abstract Full Text

free access

JAMA. 2017;318(7):662-664. doi:10.1001/jama.2017.9285

This study assesses public response to a proposed field trial in the United States of genetically engineered mosquito (OX513A) designed to suppress wild-type Aedes aegypti mosquitoes, which can transmit diseases such as Zika, dengue, and chikungunya.

Viewpoint

Consideration of Dental, Vision, and Hearing Services to Be Covered Under Medicare

Amber Willink, PhD; Cathy Schoen, MS; Karen Davis, PhD

Abstract Full Text

JAMA. 2017;318(7):605-606. doi:10.1001/jama.2017.8647

This Viewpoint argues that Medicare coverage should be expanded to include dental, vision, and hearing services, and discusses ways to structure the benefit.

Diagnostic Stewardship鈥擫everaging the Laboratory to Improve Antimicrobial Use

Daniel J. Morgan, MD, MS; Preeti Malani, MD, MSJ; Daniel J. Diekema, MD, MS

Abstract Full Text

JAMA. 2017;318(7):607-608. doi:10.1001/jama.2017.8531

This Viewpoint discusses the potential benefits and harms of diagnostic stewardship鈥攎odifying the ordering, performance, and reporting of diagnostic tests to improve treatment鈥攁s a means of reducing inappropriate antibiotic use.

Value-Based Pricing and State Reform of Prescription Drug Costs

Thomas J. Hwang, AB; Aaron S. Kesselheim, MD, JD, MPH; Ameet Sarpatwari, JD, PhD

Abstract Full Text

JAMA. 2017;318(7):609-610. doi:10.1001/jama.2017.8255

This Viewpoint discusses a New York law that allows the state to negotiate rebates with manufacturers to obtain value-based prices for drugs in its Medicaid program and assesses the potential effects of value-based pricing.

A Piece of My Mind

Climate Change: What Would Lincoln Do?

William G. Kaelin Jr, MD

Abstract Full Text

JAMA. 2017;318(7):611. doi:10.1001/jama.2017.6999

Trials and Tribulations

Jeffrey L. Brown, MD

Abstract Full Text

JAMA. 2017;318(7):612-613. doi:10.1001/jama.2017.7106

Editorial

Balancing the Need for Access With the Imperative for Empirical Evidence of Benefit and Risk

Robert M. Califf, MD

Abstract Full Text

has audio

JAMA. 2017;318(7):614-616. doi:10.1001/jama.2017.9412

Podcast: Are they safe? Drugs and devices receiving accelerated approval by the FDA

Shared Decision Making and Improving Health Care: The Answer Is Not In

Victor M. Montori, MD, MSc; Marleen Kunneman, PhD; Juan P. Brito, MD, MSc

Abstract Full Text

has audio

JAMA. 2017;318(7):617-618. doi:10.1001/jama.2017.10168

Podcast: Decision-making and the Patient

Review

Celiac Disease and Nonceliac Gluten Sensitivity: A Review

Maureen M. Leonard, MD, MMSc; Anna Sapone, MD, PhD; Carlo Catassi, MD, MPH; et al.

Abstract Full Text

JAMA. 2017;318(7):647-656. doi:10.1001/jama.2017.9730

This review discusses the the role of a gluten-free diet in the clinical management of celiac disease and nonceliac gluten sensitivity and highlights the importance for long-term therapy of distinguishing between these conditions.

JAMA Clinical Evidence Synopsis

Patient Decision Aids to Engage Adults in Treatment or Screening Decisions

Dawn Stacey, RN, PhD; France Légaré, MD, PhD; Krystina B. Lewis, RN, MN

Abstract Full Text

JAMA. 2017;318(7):657-658. doi:10.1001/jama.2017.10289

This Clinical Evidence Synopsis summarizes a Cochrane review of clinical trials evaluating patient decision aids designed to help patients understand their treatment options.

Editorial
Shared Decision Making and Improving Health Care: The Answer Is Not In
Victor M. Montori, MD, MSc; Marleen Kunneman, PhD; Juan P. Brito, MD, MSc

JAMA
- Podcast: Decision-making and the Patient

From The Medical Letter on Drugs and Therapeutics

Bezlotoxumab (Zinplava) for Prevention of Recurrent Clostridium Difficile Infection

Abstract Full Text

JAMA. 2017;318(7):659-660. doi:10.1001/jama.2017.10092

This Medical Letter review summarizes the indications, risks, and benefits of bezlotoxumab, a monoclonal antibody to be used with antibacterial drug treatment to reduce recurrence of Clostridium difficile infection in adults at high risk.

Medical News & Perspectives

Half-century After 鈥淪ummer of Love,鈥� Free Clinics Still Play Vital Role

Rita Rubin, MA

Abstract Full Text

JAMA. 2017;318(7):598-600. doi:10.1001/jama.2017.8631

This Medical News story discusses the founding of the first free clinics in the United States and the role free clinics continue to play in communities across the country.

News From the Food and Drug Administration