Devices and Diagnostics

Development, regulation, pricing, and reimbursement of medical devices and diagnostic products.

Reducing Paediatric Overweight And Obesity Through Motivational Interviewing: Study Protocol For A Randomised Controlled Trial In The AAP PROS Research Network

Alexander G. Fiks, MD, MSCE
Jul. 28, 2020

Margaret E. Wright, Emerson Delacroix, Kendrin R. Sonneville, Shannon Considine, Tim Proctor, Jennifer Steffes, Donna Harris, Laura P. Shone, Heide Woo, Roger Vaughan, Robert W. Grundmeier, Alexander G. Fiks, Melissa S. Stockwell, Ken Resnicow

Abstract [from journal]

Introduction: Primary care remains an underused venue for prevention and management of paediatric overweight and obesity. A prior trial demonstrated a significant impact of paediatrician/nurse practitioner (Ped/NP)-and registered dietitian (RD)-delivered motivational interviewing (MI) on child body mass index (BMI). The study described here will test the effectiveness of an enhanced version of this primary care-based MI counselling intervention on child BMI.

Methods and analysis: This cluster


The Contemporary Landscape Of Genetic Testing And Breast Cancer: Emerging Issues

Jul. 20, 2020

Payal D. Shah, Susan M. Domchek

Abstract [from journal]

The landscape of genetic testing for breast cancer susceptibility has transformed dramatically over the last decade and a half. Traditionally, the process of genetic testing resided fully within a medical infrastructure, from identification of appropriate testing candidates to gene selection to risk mitigation recommendations. More recently, decreasing costs, advancing technology, and a growing understanding of therapeutic implications of certain genetic test results have led to more widespread uptake of testing that increasingly


Suprapubic Versus Urethral Catheter For Urinary Drainage After Robot-Assisted Radical Prostatectomy

Leilei Xia
Jun. 6, 2020

Leilei Xia, Thomas J Guzzo, Phillip Mucksavage, Daniel J. Lee 

Abstract [from journal]

Purpose of review: To review the evidence regarding the usage of suprapubic tube (SPT) versus indwelling urethral catheter (IUC) after robot-assisted radical prostatectomy (RARP).

Recent findings: Available data on the use of SPT for urinary drainage after RARP is somewhat limited mostly because of the variations of study designs and non-standardized outcomes. Although it may provide some mild benefit in terms of catheter-related pain and discomfort, the benefit seems not to be clinically


Vaccine Rationing And The Urgency Of Social Justice In The Covid-19 Response

May. 28, 2020

Harald Schmidt

Abstract [from journal]

The Covid-19 pandemic needs to be considered from two perspectives simultaneously. First, there are questions about which policies are most effective and fair in the here and now, as the pandemic unfolds. These polices concern, for example, who should receive priority in being tested, how to implement contact tracing, or how to decide who should get ventilators or vaccines when not all can. Second, it is imperative to anticipate the medium- and longer-term consequences that these policies have. The case of vaccine rationing is


A Randomized Trial of Behavioral Nudges to Improve Enrollment in Critical Care Trials

May. 22, 2020

Dustin C. Krutsinger, Kelly L. O'Leary, Susan S. Ellenberg, Cody E. Cotner, Scott D. Halpern, Katherine R. Courtright

Abstract [from journal]

Rationale: Low and slow patient enrollment remains a barrier to critical care randomized controlled trials (RCTs). Behavioral economic insights suggest that nudges may address some enrollment challenges.

Objectives: To evaluate the efficacy of a novel pre-consent survey consisting of nudges on critical care RCT enrollment.

Methods: We conducted an RCT in 10 intensive care units (ICUs) among surrogate decision-makers (SDMs). The novel multi-component behavioral nudge survey was...

A Randomized Trial Of Behavioral Nudges To Improve Enrollment In Critical Care Trials

May. 22, 2020

Dustin C Krutsinger, Kelly L O'Leary, Susan S Ellenberg, Cody E Cotner, Scott D Halpern, Katherine R Courtright

Abstract [from journal]

Rationale: Low and slow patient enrollment remains a barrier to critical care randomized controlled trials (RCTs). Behavioral economic insights suggest that nudges may address some enrollment challenges.

Objectives: To evaluate the efficacy of a novel pre-consent survey consisting of nudges on critical care RCT enrollment.

Methods: We conducted an RCT in 10 intensive care units (ICUs) among surrogate decision-makers (SDMs). The novel multi-component behavioral nudge survey was...

Evaluating Delirium Outcomes Among Older Adults In The Surgical Intensive Care Unit

May. 17, 2020

Kara J Pavone, Juliane Jablonski, Paul Junker, Pamela Z Cacchione, Peggy Compton, Rosemary C Polomano

Abstract [from journal]

Background: Delirium is prevalent in hospitalized older adults. Little is known about delirium among older adults admitted to the surgical intensive care unit (SICU).

Objectives: The purpose of this study was to describe the incidence of delirium, length of stay, 30-day readmission and mortality rates experienced by older adults in the SICU before and after a nurse-driven protocol for delirium-informed care.

Methods: This study employed a retrospective observational cohort...

Identifying the Organizational Innovation-specific Capacity Needed for Exposure Therapy

May. 10, 2020

Emily M. Becker‐Haimes, Young Vivian Byeon, Hannah E. Frank, Nathaniel J. Williams, Hilary E. Kratz, Rinad S. Beidas

Abstract [from journal]

Background: Current approaches to increasing the rates of clinician use of exposure therapy for anxiety disorders in community settings are limited. Research underscores the importance of addressing contextual variables to facilitate clinician use of evidence-based practices; however, no studies have identified the innovation-specific organizational capacity necessary to implement exposure therapy. Such work is critical to ensure that treatment-seeking individuals with anxiety receive effective care.



Predictors of 30-Day Readmission and Resource Utilization After Thoracic Endovascular Aortic Repair

Nimesh Desai, MD, PhD
May. 9, 2020

Amit Iyengar, Nicholas J. Goel, John J. Kelly, Jason HanChase R. Brown, Fabliha Khurshan, Zehang Chen, Nimesh D. Desai

Abstract [from journal]

Objectives: The introduction and expansion of thoracic endovascular aortic repair (TEVAR) have revolutionized the treatment of a variety of thoracic aortic diseases. We sought to evaluate the incidence, causes, predictors and costs associated with 30-day readmission after TEVAR in a nationally representative cohort.

Methods: Adult patients undergoing isolated TEVAR were identified in the National Readmissions Database from 2010 to 2014. Hospital costs were estimated by converting individual hospital charge data


Association of Utilization Management Policy With Uptake of Hypofractionated Radiotherapy Among Patients With Early-Stage Breast Cancer

Apr. 16, 2020

Ravi B. Parikh, Ezra Fishman, Winnie Chi, Robert P. Zimmerman, Atul Gupta, John J. Barron, Gosia Sylwestrzak, Justin E. Bekelman

Abstract [from journal]

Importance: Breast cancer accounts for the largest portion of cancer-related spending in the United States. Although hypofractionated radiotherapy after breast-conserving surgery is a cost-effective and convenient treatment strategy for patients with early-stage breast cancer, less than 40% of eligible women received hypofractionated radiotherapy in 2013.

Objective: To assess the association of a large commercial payer's utilization management policy with the use of hypofractionated radiotherapy among women


Association of Demographic, Clinical, and Hospital-Related Factors With Use of Robotic Hysterectomy for Benign Indications: A National Database Study

Anna Jo Smith
Apr. 10, 2020

Anna Jo B. Smith, Abdelrahman AlAshqar, Kate F. Chaves, Mostafa A. Borahay

Abstract [from journal]

Background: We examined the association of patient factors, gynecologic diagnoses, and hospital characteristics with utilization of the robotic approach for benign hysterectomy.

Methods: We performed cross‐sectional study of women (n = 725 050) undergoing hysterectomies in the 2012 to 2014 National Inpatient Sample.


The Volume-Outcome Relationship in Robotic Proctectectomy: Does Center Volume Matter? Results of a National Cohort Study

E. Carter Paulson, MD, MSCE
Oct. 21, 2019

Seth J. Concors, Douglas R. Murken, Paul T. Hernandez, Najjia N. Mahmoud, E. Carter Paulson

Abstract [from journal]

Background: Utilization of robotic proctectomy (RP) for rectal cancer has steadily increased since the inception of robotic surgery in 2002. Randomized control trials evaluating the safety of RP are in process to better understand the role of robotic assistance in proctectomy. This study aimed to characterize the trends in the use of RP for rectal cancer, and to compare oncologic outcomes with center-level RP volume.

Materials and Methods: 8107 patients with rectal adenocarcinoma who underwent RP were


Performance of a Clinical Decision Support Tool to Identify PICU Patients at High Risk for Clinical Deterioration

Heather Wolfe, MD
Oct. 2, 2019

Maya Dewan, Naveen Muthu, Eric Shelov, Christopher Bonafide, Patrick Brady, Daniela Davis, Eric Kirkendall, Dana Niles, Robert Sutton, Danielle Traynor, Ken Tegtmeyer, Vinay Nadkarni, Heather Wolfe

Abstract [from journal]

Objectives: To evaluate the translation of a paper high-risk checklist for PICU patients at risk of clinical deterioration to an automated clinical decision support tool.

Design: Retrospective, observational cohort study of an automated clinical decision support tool, the PICU Warning Tool, adapted from a paper checklist to predict clinical deterioration events in PICU patients within 24 hours.

Setting: Two quaternary care medical-surgical PICUs—The Children’s Hospital of Philadelphia and...

Effect of Prices, Distribution Strategies, and Marketing on Demand for HIV Self-testing in Zimbabwe: A Randomized Clinical Trial

Aug. 28, 2019

Wei Chang, Primrose Matambanadzo, Albert Takaruza, Karin Hatzold, Frances M. Cowan, Euphemia Sibanda, Harsha Thirumurthy

Abstract [from journal]

Importance: HIV self-testing is a promising approach for increasing awareness of HIV status in sub-Saharan Africa, particularly in Zimbabwe, where HIV prevalence is 13%. Evidence is lacking, however, on the optimal pricing policies and delivery strategies for maximizing the effect of HIV self-testing.

Objective: To assess demand for HIV self-testing among adults and priority-population subgroups under alternative pricing and distribution strategies.

Design, Setting, and Participants:...