Analysis of Devices Authorized by the FDA for Clinical Decision Support in Critical Care.

This case series study examines the clinical evidence cited for US Food and Drug Administration­approved clinical decision support devices for use in the critical care setting.

Artificial Intelligence and Liability in Medicine: Balancing Safety and Innovation.

Policy Points With increasing integration of artificial intelligence and machine learning in medicine, there are concerns that algorithm inaccuracy could lead to patient injury and medical liability. While prior work has focused on medical malpractice, the artificial intelligence ecosystem consists of multiple stakeholders beyond clinicians. Current liability frameworks are inadequate to encourage both safe clinical implementation and disruptive innovation of artificial intelligence. Several policy options could ensure a more balanced liability system, including altering the standard of care, insurance, indemnification, special/no-fault adjudication systems, and regulation. Such liability frameworks could facilitate safe and expedient implementation of artificial intelligence and machine learning in clinical care.

Legal implications of antibiotic stewardship programs.

Infectious diseases professional societies, public health agencies, and healthcare regulatory agencies call for antibiotic stewardship programs (ASP) in many healthcare settings. However, medical legal implications of these programs remain largely uncharted territory. Although there is no legal precedent addressing issues of liability and standards of care on this subject, anticipating how the courts may assess questions of medical liability with respect to the various components of ASPs is important to define best practices in ASP operations, not only to manage the potential risk but also to improve patient care. This article seeks to address some of the common processes and interventions involved in antibiotic stewardship and the potential professional liability implications of these activities.

A study of the VaSera arterial stiffness device in US patients.

The cardio-ankle vascular index (CAVI) represents a promising index of arterial stiffness. However, neither the CAVI measure nor its measurement device, the VaSera, have undergone general testing in a North American clinical setting. To begin the process of collecting normal values in the United States, we studied 20 male and 28 female volunteers without reported cardiovascular or renal disease and no history of smoking. Their CAVIs, ankle-brachial indices (ABIs), and four-limb blood pressures were measured in three positions: supine, 7° Trendelenburg, and 7° reverse Trendelenburg. In addition, the ABI function was validated against an established ABI measurement technique. Position was found to affect CAVI and other hemodynamic parameters, indicating that CAVI is not robust to slight positional variations. No differences were found in the blood pressure between arms or legs (interbrachial or interankle), supporting recent findings from meta-analyses and studies but contradicting other work. This study represents an early step in bringing the VaSera device and its CAVI measurement into clinical practice.

Levels of Influence: Habituation and the Prevalence of Declared Conflicts of Interest.

BACKGROUND: The International Committee of Medical Journal Editors has devised a system of mandatory disclosure, under which authors are required to disclose all conflicts of interest and the sources of support for the submitted research. Because payments from industry to physicians generally are common, it is likely that many authors of medical manuscripts will have information to disclose. As a result, the signal-to-noise ratio of such declarations may be low, thereby undermining the effectiveness of disclosure. To our knowledge, the comparative prevalence of such conflicts has not been reported. METHODS: We identified 100 consecutive scientific articles from the 2014 volumes of 3 journals with high impact factors: Pediatrics, The Journal of Bone & Joint Surgery (JBJS), and The New England Journal of Medicine (NEJM). Each study was categorized by funding source and other relationships with industry. RESULTS: In Pediatrics, 17 of 100 studies had a declared relationship with industry. Industry relationships were declared in 68 and 77 of the studies in JBJS and NEJM, respectively. CONCLUSIONS: Industry relationships were common in studies in NEJM and JBJS, but rare in Pediatrics. The high prevalence of conflicts of interest may weaken the meaning of declarations and undermine any bias-reducing effect intended by the disclosure system.

SGLT2 inhibitors: their potential reduction in blood pressure.

The sodium glucose co-transporter 2 (SGLT2) inhibitors represent a promising treatment option for diabetes and its common comorbidity, hypertension. Emerging data suggests that the SGLT2 inhibitors provide a meaningful reduction in blood pressure, although the precise mechanism of the blood pressure drop remains incompletely elucidated. Based on current data, the blood pressure reduction is partially due to a combination of diuresis, nephron remodeling, reduction in arterial stiffness, and weight loss. While current trials are underway focusing on cardiovascular endpoints, the SGLT2 inhibitors present a novel treatment modality for diabetes and its associated hypertension as well as an opportunity to elucidate the pathophysiology of hypertension in diabetes.

Transient osteoporosis of pregnancy.

Transient osteoporosis of pregnancy (TOP) is a rare yet perhaps under-reported condition that has affected otherwise healthy pregnancies throughout the world. The condition presents suddenly in the third trimester of a usually uneventful pregnancy and progressively immobilizes the mother. Radiographic studies detect drastic loss of bone mass, elevated rates of turnover in the bone, and oedema in the affected portion. Weakness of the bone can lead to fractures during delivery and other complications for the mother. Then, within weeks of labour, symptoms and radiological findings resolve. Aetiology is currently unknown, although neural, vascular, haematological, endocrine, nutrient-deficiency, and other etiologies have been proposed. Several treatments have also been explored, including simple bed rest, steroids, bisphosphonates, calcitonin, induced termination of pregnancy, and surgical intervention. The orthopedist plays an essential role in monitoring the condition (and potential complications) as well as ensuring satisfactory outcomes for both the mother and newborn.