Oncology clinical trial disruption during the COVID-19 pandemic: a COVID-19 and cancer outcomes study.

BACKGROUND: COVID-19 disproportionately impacted patients with cancer as a result of direct infection, and delays in diagnosis and therapy. Oncological clinical trials are resource-intensive endeavors that could be particularly susceptible to disruption by the pandemic, but few studies have evaluated the impact of the pandemic on clinical trial conduct. PATIENTS AND METHODS: This prospective, multicenter study assesses the impact of the pandemic on therapeutic clinical trials at two large academic centers in the Northeastern United States between December 2019 and June 2021. The primary objective was to assess the enrollment on, accrual to, and activation of oncology therapeutic clinical trials during the pandemic using an institution-wide cohort of (i) new patient accruals to oncological trials, (ii) a manually curated cohort of patients with cancer, and (ii) a dataset of new trial activations. RESULTS: The institution-wide cohort included 4756 new patients enrolled to clinical trials from December 2019 to June 2021. A major decrease in the numbers of new patient accruals (-46%) was seen early in the pandemic, followed by a progressive recovery and return to higher-than-normal levels (+2.6%). A similar pattern (from -23.6% to +30.4%) was observed among 467 newly activated trials from June 2019 to June 2021. A more pronounced decline in new accruals was seen among academically sponsored trials (versus industry sponsored trials) (P < 0.05). In the manually curated cohort, which included 2361 patients with cancer, non-white patients tended to be more likely taken off trial in the early pandemic period (adjusted odds ratio: 2.60; 95% confidence interval 1.00-6.63), and substantial pandemic-related deviations were recorded. CONCLUSIONS: Substantial disruptions in clinical trial activities were observed early during the pandemic, with a gradual recovery during ensuing time periods, both from an enrollment and an activation standpoint. The observed decline was more prominent among academically sponsored trials, and racial disparities were seen among people taken off trial.

Acute and chronic propylene glycol dinitrate exposure in the monkey.

Rhesus monkeys (Macaca mulatta) were exposed to propylene glycol 1,2-dinitrate (PGDN) vapors on either an acute (4-h) or chronic (125-d) schedule. During acute exposures, PGDN concentrations ranged from a low of 2 ppm (parts per million) to a high of 33 ppm. Free operant avoidance behavior and visual evoked responses were monitored and free operant avoidance was not affected at any dose level. The late positive (100-150 ms) wave of the visual evoked response increased 20% at 2 ppm and decreased 25% at concentrations up to 33 ppm. Although these changes were statistically different from control values, they were within the limits caused by distracting events (+/-40%), and might possibly have been caused by the irritating or distracting properties of the vapor. Other monkeys were exposed to successively increasing concentrations of PGDN vapors at 0.3-4.2 ppm. 23 h/d, for 125 d. Daily performance testing included alternating sessions of discrete-trial cued avoidance and free operant avoidance. Non of the PGDN concentrations had a discernible effect on either type of avoidance performance.

An interview with Linda Slezak.

As director of the operating room region and assistant director of nursing at Stanford University Hospital, Linda Slezak, MSN, RN, represented Stanford on the surgical services council of the University HealthSystems Consortium. She chaired a task force which initiated a Surgical Services Benchmarking Project for perioperative services in academic health centers. In this interview, Ms. Slezak discusses the importance of benchmarking, defining best practices, and achieving benchmarking success.

The impact of corporate culture on nurse retention.

This article concerns the impact of the corporate culture of today's hospitals on the hospital's ability to attract and retain nurses. Several sources are used to illuminate recent sociohistoric changes that have had a profound impact on the business of health care and the professional world of staff nurses. Organizational characteristics that are associated with successful nurse retention strategies are offered.

A database to describe the practice component of the CNS role.

The purpose of this paper is to describe the development of the database and its usefulness in describing clinical nurse specialist (CNS) practice, providing the CNS with clinical information about specific patients, and identifying patterns and trends about the care for the specialty patient population during a 3-month pilot period. The pilot revealed that the database, which included elements of clinical encounters between the CNS and patients, was useful in organizing clinical information about patients and the specialty population and in describing the nature of the CNS practice. It provided a quantitative description of the process of CNS functioning that, when combined with data about actions and outcomes, will allow relations to be drawn. The organizing framework of the database may be replicated by CNSs who are interested in describing the nature of their clinical practice.

The nursing shortage becomes a growing human resource priority.

As trustees nationwide are discovering, the nursing shortage is rapidly becoming a top human resource priority. With the number of vacant positions for registered nurses on the upswing, hospitals are under increasing pressure to maintain cost-effective, high-quality health care.