Direct-to-participant recruitment of mothers and infants: A strategic approach during challenging pandemic times.

Under traditional circumstances, most clinical trials rely on in-person operations to identify, recruit, and enroll study participants and to complete study-related visits. During unusual circumstances, such as the COVID-19 pandemic, the typical clinical trial model is challenged and forced to explore alternative approaches to implementing study recruitment, participant enrollment, and data collection strategies. One such alternative is a direct-to-participant approach which leverages electronic resources and relevant technological devices (e.g., smart phones) available to researchers and patients. This approach functions under the assumption that a participant has access to a device that connects to the internet such as a smart phone, tablet, or computer. Researchers are then able to transition a typical paper-based, in-person model to an electronic-based, siteless, remote study. This article describes the challenges clinicians and researchers faced when implementing a direct-to-participant study approach during the COVID-19 pandemic. The lessons learned during this study of infant populations could help increase efficiency of future trials, specifically, by lessening the burden on participants and clinicians as well as streamlining the process for enrollment and data collection. While direct-to-adult participant recruitment is not a novel approach, our findings suggest that studies attempting to recruit the infant population may benefit from such a direct-to-participant approach.

Delayed vomiting in children with cancer after receiving moderately high or highly emetogenic chemotherapy.

Delayed vomiting is a potentially significant adverse effect of chemotherapy used to treat childhood cancer, but little is known about the experience of delayed vomiting in children and adolescents. An exploratory study was conducted to determine the pattern of delayed vomiting in children and adolescents with cancer after highly emetic chemotherapy and to identify possible risk factors. In a sample of 82 children and adolescents who completed 117 cycles of highly emetic chemotherapy, the overall prevalence of delayed vomiting was 32%. The frequency of delayed vomiting was highest on delayed day 2, with 21% of participants experiencing vomiting. By delayed day 7, only 9% of participants still reported vomiting. The severity of vomiting was moderate to severe in 11% to 12% of subjects. Age and gender had no significant effect on delayed vomiting. The emetic potential of the agent, incomplete protection from acute vomiting, and treatment regimens that lasted 6 or more days significantly affected delayed vomiting. In addition, a history of motion sickness, lack of acute control, and 6 or more days of chemotherapy were predictive of delayed vomiting.

Medical futility in the neonatal intensive care unit: hope for a resolution.

Contemporary medical practice in the NICU sometimes leads to conflicts between providers and parents in which the parent demands continuation of life-sustaining treatment that the medical team deems medically inappropriate or futile. Such conflicts can be difficult to resolve and trying for all parties. Here we describe a conflict involving a 25-week-gestation, 825-g newborn with multiple intractable medical problems and resolution of the conflict through ethics consultation under provisions of the Texas Advance Directives Act. The process established under Texas law sets conceptual and temporal boundaries around the problem of medical futility and provides a legal safe harbor for physicians who seek to withdraw life-sustaining treatments in the setting of medical futility, allowing resolution of such conflicts in a timely and effective manner. As such, it may provide a model for physicians in other states to follow.