Diabetes Technology: Review of the 2019 American Diabetes Association Standards of Medical Care in Diabetes

Description: The American Diabetes Association (ADA) annually updates its Standards of Medical Care in Diabetes to provide clinicians, patients, researchers, payers, and other interested parties with evidence-based recommendations for the diagnosis and management of patients with diabetes. Methods: The ADA Professional Practice Committee comprises physicians, adult and pediatric endocrinologists, diabetes educators, registered dietitians, epidemiologists, pharmacists, and public health experts. To develop the 2019 standards, the committee continuously searched MEDLINE through November 2018 to consider and review studies, particularly high-quality trials including persons with diabetes, for potential incorporation into recommendations. It also solicited feedback from the larger clinical community. Recommendations: This synopsis focuses on selected guidance relating to use of diabetes technology in adults with diabetes. Recommendations address self-monitoring of blood glucose, continuous glucose monitors, and automated insulin delivery systems.

Prevention, Diagnosis, Evaluation, and Treatment of Hepatitis C Virus Infection in Chronic Kidney Disease: Synopsis of the Kidney Disease: Improving Global Outcomes 2018 Clinical Practice Guideline

This article has been corrected. The original version (PDF) is appended to this article as a Supplement. Description: The Kidney Disease: Improving Global Outcomes (KDIGO) 2018 clinical practice guideline for the prevention, diagnosis, evaluation, and treatment of hepatitis C virus (HCV) infection in chronic kidney disease (CKD) is an extensive update of KDIGO's 2008 guideline on HCV infection in CKD. This update reflects the major advances since the introduction of direct-acting antivirals (DAAs) in the management of HCV infection in the CKD population. Methods: The KDIGO work group tasked with developing the HCV and CKD guideline defined the scope of the guideline, gathered evidence, determined topics for systematic review, and graded the quality of evidence previously summarized by the evidence review team. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach was used to appraise the quality of evidence and rate the strength of the recommendations. Searches of the English-language literature were conducted through May 2017 and were supplemented with targeted searches for studies of DAA treatment and with abstracts from nephrology, hepatology, and transplantation conferences. A review process involving many stakeholders, subject matter experts, and industry and national organizations informed the guideline's final modification. Recommendation: The updated guideline comprises 66 recommendations. This synopsis focuses on 32 key recommendations pertinent to the prevention, diagnosis, treatment, and management of HCV infection in adult CKD populations.

Presenting Risks and Benefits: Helping the Data Monitoring Committee Do Its Job

Data monitoring committees (DMCs), or data and safety monitoring boards, protect clinical trial participants by conducting benefit–risk assessments during the course of a clinical trial. These evaluations may be improved by broader access to data and more effective analyses and presentation. Data monitoring committees should have access to all data, including efficacy data, at each interim review. The DMC reports should include graphical presentations that summarize benefits and harms in efficient ways. Benefit–risk assessments should include summaries that are consistent with the intention-to-treat principle and have a pragmatic focus. This article provides examples of graphical summaries that integrate benefits and harms, and proposes that such summaries become standard in DMC reports.

Insights on the Natural History of Adrenal Incidentalomas

Sodium–Glucose Cotransporter-2 Inhibitors: Lack of a Complete History Delays Diagnosis

On 15 May 2015, the U.S. Food and Drug Administration (FDA) warned that administration of sodium–glucose cotransporter-2 (SGLT2) inhibitors could lead to ketoacidosis in patients with diabetes mellitus. This announcement came more than 2 years after the FDA's first approval of an SGLT2 inhibitor, although the phenomenon had been known for more than 125 years. Luminaries of diabetes research (including Josef von Mering, Frederick Allen, I. Arthur Mirsky, and George Cahill) had described ketosis and ketoacidosis induced by administration of the phytochemical phlorizin, the prototypical SGLT inhibitor, as well as in patients with familial renal glucosuria, a condition that is considered a natural model of SGLT2 inhibition. Neither government regulators nor manufacturers of SGLT2 inhibitors evinced an awareness of this extensive historical record. The absence of historical inquiry delayed notice of ketoacidosis as an adverse reaction, which could have reduced the burden of illness from these drugs.

Role of an Accurate Treatment Locator and Cash-Only Practices in Access to Buprenorphine for Opioid Use Disorders

Cases in Precision Medicine: APOL1 and Genetic Testing in the Evaluation of Chronic Kidney Disease and Potential Transplant

This article discusses potential indications for genetic testing in an African American patient with chronic kidney disease who is being evaluated for a kidney transplant. Two known risk variants in the APOL1 (apolipoprotein L1) gene predispose to kidney disease and are found almost exclusively in persons of African ancestry. APOL1 risk variants are considered, including whether clinicians should incorporate genetic testing in the screening process for living kidney donors. In addition to APOL1 testing, the role of diagnostic exome sequencing in evaluating potential transplant recipients and donors with a positive family history of kidney disease is discussed.

Life-Gained–Based Versus Risk-Based Selection of Smokers for Lung Cancer Screening

Background: Although risk-based selection of ever-smokers for screening could prevent more lung cancer deaths than screening according to the U.S. Preventive Services Task Force (USPSTF) guidelines, it preferentially selects older ever-smokers with shorter life expectancies due to comorbidities. Objective: To compare selection of ever-smokers for screening based on gains in life expectancy versus lung cancer risk. Design: Cohort analyses and model-based projections. Setting: U.S. population of ever-smokers aged 40 to 84 years. Participants: 130 964 National Health Interview Survey participants, representing about 60 million U.S. ever-smokers during 1997 to 2015. Intervention: Annual computed tomography (CT) screening for 3 years versus no screening. Measurements: Estimated number of lung cancer deaths averted and life-years gained after development of a mortality model. Results: Using the calibrated and validated mortality model in U.S. ever-smokers aged 40 to 84 years and selecting 8.3 million ever-smokers to match the number selected by the USPSTF criteria in 2013 to 2015, the analysis estimated that life-gained–based selection would increase the total life expectancy from CT screening (633 400 vs. 607 800 years) but prevent fewer lung cancer deaths (52 600 vs. 55 000) compared with risk-based selection. The 1.56 million persons selected by the life-gained–based strategy but not the risk-based strategy were younger (mean age, 59 vs. 75 years) and had fewer comorbidities (mean, 0.75 vs. 3.7). Limitation: Estimates are model-based and assume implementation of lung cancer screening with short-term effectiveness similar to that from trials. Conclusion: Life-gained–based selection could maximize the benefits of lung cancer screening in the U.S. population by including ever-smokers who have both high lung cancer risk and long life expectancy. Primary Funding Source: Intramural Research Program of the National Cancer Institute, National Institutes of Health.

Beyond the Economics of Burnout

National Institutes of Health Pathways to Prevention Workshop: Research Gaps for Long-Term Drug Therapies for Osteoporotic Fracture Prevention

On 30 and 31 October 2018, the National Institutes of Health convened the Pathways to Prevention (P2P) Workshop: Appropriate Use of Drug Therapies for Osteoporotic Fracture Prevention to assess the available evidence on long-term (>3 years) use of drug therapies to prevent osteoporotic fractures and identify research gaps and needs for advancing the field. The workshop was cosponsored by the NIH Office of Disease Prevention (ODP), National Institute of Arthritis and Musculoskeletal and Skin Diseases, and National Institute on Aging. A multidisciplinary working group developed the agenda, and an Evidence-based Practice Center prepared an evidence report through a contract with the Agency for Healthcare Research and Quality to facilitate the discussion. During the 1.5-day workshop, invited experts discussed the body of evidence and attendees had the opportunity to comment during open discussions. After data from the evidence report, expert presentations, and public comments were weighed, an unbiased independent panel prepared a draft report that was posted on the ODP Web site for 5 weeks for public comment. This final report summarizes the panel's findings and recommendations. Current gaps in knowledge are highlighted, and a set of recommendations for new, strengthened research to better inform the long-term use of osteoporotic drug therapies is delineated.