Clinical Consensus Statement: Balloon Dilation of the Eustachian Tube.

Objective: To develop a clinical consensus statement on the use of balloon dilation of the eustachian tube (BDET).

Methods: An expert panel of otolaryngologists was assembled with nominated representatives of general otolaryngology and relevant subspecialty societies. The target population was adults 18 years or older who are candidates for BDET because of obstructive eustachian tube dysfunction (OETD) in 1 or both ears for 3 months or longer that significantly affects quality of life or functional health status.

Symptom Profile of Chronic Rhinosinusitis Versus Obstructive Sleep Apnea in a Tertiary Rhinology Clinic.

Objectives: Patients with undiagnosed obstructive sleep apnea (OSA) often present to an otolaryngologist with symptoms of chronic rhinosinusitis (CRS). This study analyzes symptom profiles of such patients to help identify those who may benefit from polysomnography.

Methods: This is a 2-year retrospective analysis of adult patients at an academic practice with a rhinologic chief complaint.

Tailored Treatment Strategies for Chronic Lymphocytic Leukemia in a Rapidly Changing Era.

The treatment landscape for chronic lymphocytic leukemia (CLL) is rapidly evolving, with multiple agents recently approved. They include a glycoengineered monoclonal antibody (obinutuzumab), B-cell receptor signaling inhibitors (ibrutinib, idelalisib, and duvelisib), and the BCL-2 inhibitor (venetoclax). These compounds are dramatically changing the natural course of the disease.

Financial Toxicity and Equitable Access to Clinical Trials.

Financial barriers to clinical trial enrollment are an area of active investigation. Financial toxicity as a concept describes how high costs and financial burden can lead to compromised care and outcomes. Despite the potential to yield large survival benefits and improved access to cutting-edge therapies, less than 5% of adult patients with cancer are enrolled in a clinical trial.

Addressing guideline and policy changes during pragmatic clinical trials.

While conducting a set of large-scale multi-site pragmatic clinical trials involving high-impact public health issues such as end-stage renal disease, opioid use, and colorectal cancer, there were substantial changes to both policies and guidelines relevant to the trials. These external changes gave rise to unexpected challenges for the trials, including decisions regarding how to respond to new clinical practice guidelines, increased difficulty in implementing trial interventions, achieving separation between treatment groups, and differential responses across sites. In this article, we describe these challenges and the approaches used to address them.

National Trends in End-of-Life Care for Veterans With Advanced Cancer in the Veterans Health Administration: 2009 to 2016.

Purpose: It is imperative to provide quality end-of-life (EOL) care for patients with cancer. Although rates of hospice use within the Veterans Health Administration have improved, antineoplastic administration and intensive care unit (ICU) admission at the EOL, indicators of aggressive care, have not clearly declined over recent years.

Methods: We identified 32,665 veterans diagnosed with stage IV lung, colorectal, or pancreatic cancer who died between 2009 and 2016 using a novel EOL Dashboard Tool created from Veterans Administration Cancer Registry data.

A 17-Year-Old Girl With Unilateral Headache and Double Vision.

Tolosa-Hunt syndrome is characterized by a painful ophthalmoplegia secondary to a granulomatous inflammation in or adjacent to the cavernous sinus. Magnetic resonance imaging will show enhancement of the cavernous sinus and/or the orbital apex. Although this syndrome is extremely rare in children, it should be a diagnostic consideration in patients presenting with painful ophthalmoplegia with variable involvement of cranial nerves II to VI.

Prospective Multicenter Validation of Androgen Receptor Splice Variant 7 and Hormone Therapy Resistance in High-Risk Castration-Resistant Prostate Cancer: The PROPHECY Study.

Purpose: Androgen receptor splice variant 7 (AR-V7) results in a truncated receptor, which leads to ligand-independent constitutive activation that is not inhibited by anti-androgen therapies, including abiraterone or enzalutamide. Given that previous reports suggested that circulating tumor cell (CTC) AR-V7 detection is a poor prognostic indicator for the clinical efficacy of secondary hormone therapies, we conducted a prospective multicenter validation study.

Patients And Methods: PROPHECY ( ClinicalTrials.

First-Line Nivolumab Plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer (CheckMate 568): Outcomes by Programmed Death Ligand 1 and Tumor Mutational Burden as Biomarkers.

Purpose: CheckMate 568 is an open-label phase II trial that evaluated the efficacy and safety of nivolumab plus low-dose ipilimumab as first-line treatment of advanced/metastatic non-small-cell lung cancer (NSCLC). We assessed the association of efficacy with programmed death ligand 1 (PD-L1) expression and tumor mutational burden (TMB).

Patients And Methods: Two hundred eighty-eight patients with previously untreated, recurrent stage IIIB/IV NSCLC received nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks.

Caregiver-guided pain coping skills training for patients with advanced cancer: Background, design, and challenges for the CaringPals study.

Background/aims: Pain is a major concern of patients with advanced cancer and their caregivers. There is strong evidence that pain coping skills training interventions based on cognitive-behavioral principles can reduce pain severity and pain interference. However, few such interventions have been tested for patients with advanced cancer and their family caregivers.

Early Impact of the Patient Protection and Affordable Care Act on Delivery of Children's Surgical Care.

The impact of the Patient Protection and Affordable Care Act (PPACA) on children's access to surgical care is not well-defined. Our objective was to describe the early impact of PPACA on children's surgical care before and after Medicaid expansion in 2014. We compared pediatric and young adult surgical outcomes in 2013 and 2014 in Medicaid expansion and nonexpansion states; young adults were included as a control group.

Medication Histories in Critically Ill Patients Completed by Pharmacy Personnel.

Background: Although critically ill adults often have extended hospital lengths of stay and are at high risk of having medication-related adverse events, the value of medication histories in these patients remains underreported.

Objective: To assess the feasibility of performing medication histories in critically ill adults and to establish the frequency of and characterize identified discrepancies.

Methods: This prospective study included patients admitted to 4 intensive care units (ICUs) in a large academic medical center and was conducted in 2 phases.

Overall Survival of Black and White Men With Metastatic Castration-Resistant Prostate Cancer Treated With Docetaxel.

Purpose: Several studies have reported that among patients with localized prostate cancer, black men have a shorter overall survival (OS) time than white men, but few data exist for men with advanced prostate cancer. The primary goal of this analysis was to compare the OS in black and white men with metastatic castration-resistant prostate cancer (mCRPC) who were treated in phase III clinical trials with docetaxel plus prednisone (DP) or a DP-containing regimen.

Methods: Individual participant data from 8,820 men with mCRPC randomly assigned in nine phase III trials to DP or a DP-containing regimen were combined.

Phase I/II Study of Stem-Cell Transplantation Using a Single Cord Blood Unit Expanded Ex Vivo With Nicotinamide.

Purpose: Increasing the number of hematopoietic stem and progenitor cells within an umbilical cord blood (UCB) graft shortens the time to hematopoietic recovery after UCB transplantation. In this study, we assessed the safety and efficacy of a UCB graft that was expanded ex vivo in the presence of nicotinamide and transplanted after myeloablative conditioning as a stand-alone hematopoietic stem-cell graft.

Methods: Thirty-six patients with hematologic malignancies underwent transplantation at 11 sites.

Reducing Social Judgment Biases May Require Identifying the Potential Source of Bias.

Social judgment is shaped by multiple biases operating simultaneously, but most bias-reduction interventions target only a single social category. In seven preregistered studies (total > 7,000), we investigated whether asking participants to avoid one social bias affected that and other social biases. Participants selected honor society applicants based on academic credentials.

Exploring patient-provider decision-making for use of anticoagulation for stroke prevention in atrial fibrillation: Results of the INFORM-AF study.

Background: Atrial fibrillation is associated with stroke, yet approximately 50% of patients are not treated with guideline-directed oral anticoagulants (OACs).

Aims: Given that the etiology of this gap in care is not well understood, we explored decision-making by patients and physicians regarding OAC use for stroke prevention in atrial fibrillation.

Methods And Results: We conducted a descriptive qualitative study among providers ( N=28) and their patients with atrial fibrillation for whom OACs were indicated ( N=25).

Possible Implications for Bundled Payment Models of Comorbidities and Complications as Drivers of Cost in Total Ankle Arthroplasty.

Background:: The Comprehensive Care for Joint Replacement (CJR) model provides bundled payments for in-hospital and 90-day postdischarge care of patients undergoing total ankle arthroplasty (TAA). Defining patient factors associated with increased costs during TAA could help identify modifiable preoperative patient factors that could be addressed prior to the patient entering the bundle, as well as determine targets for cost reduction in postoperative care.

Methods:: This study is part of an institutional review board-approved single-center observational study of patients undergoing TAA from January 1, 2012, to December 15, 2016.

Characterization of the Recommendations in the Choosing Wisely Initiative.

Choosing Wisely is a comprehensive set of recommendations that guides clinicians and patients away from low-value services. The recommendations were reviewed to investigate their breadth and limitations. The authors performed an abstraction of all Choosing Wisely recommendations between March 1 and May 27, 2016.