Extrapolation of Efficacy from Adults to Pediatric Patients of Drugs for Treatment of Partial Onset Seizures: A Regulatory Perspective.

The US Food and Drug Administration (FDA) has concluded that the efficacy of drugs approved for the treatment of partial onset seizures (POS) in adults can be extrapolated to pediatric patients 1 month of age and above and that independent efficacy trials in this pediatric population are no longer needed. This paper focuses on the dosing, pharmacokinetic (PK), exposure-response, and clinical information that were leveraged from the approved drugs for the treatment of POS to conduct analyses that supported extrapolation of efficacy in pediatric patients. Clinical data from trials for eight drugs (levetiracetam, oxcarbazepine, topiramate, lamotrigine, gabapentin, perampanel, tiagabine, and vigabatrin) approved in both adults and pediatric patients for the treatment of POS were analyzed.

Severe Acute Respiratory Syndrome Coronavirus 2 Seropositivity among Healthcare Personnel in Hospitals and Nursing Homes, Rhode Island, USA, July-August 2020.

Healthcare personnel are recognized to be at higher risk for infection with severe acute respiratory syndrome coronavirus 2. We conducted a serologic survey in 15 hospitals and 56 nursing homes across Rhode Island, USA, during July 17-August 28, 2020. Overall seropositivity among 9,863 healthcare personnel was 4.

An observational study to assess an electronic point-of-care wound documentation and reporting system regarding user satisfaction and potential for improved care.

The integration of information technology into daily patient care potentially provides a means to standardize care and enable continuous quality improvement through improved communication among care teams. A 2-month observational study was conducted on 38 residents with pressure ulcers at a 51-bed skilled nursing facility to rate the Ease of Use and Wound Management Effectiveness of a point-of-care electronic wound documentation system. Nine nurses evaluated the use of handheld "smart phone" devices equipped with a digital camera to document pressure ulcer assessment and treatment at point of care.

Extrapolation of adult data and other data in pediatric drug-development programs.

Objectives: In 1994, the US Food and Drug Administration (FDA) proposed an approach, based on extrapolation of efficacy findings from adults to the pediatric population, to maximize the use of adult data and other data when designing pediatric drug-development programs. We examined the experience of the FDA in using extrapolation to evaluate how and when it was used and any changes in scientific assumptions over time.

Methods: We reviewed 370 pediatric studies submitted to the FDA between 1998 and 2008 in response to 159 written requests (166 products) issued under the Pediatric Exclusivity Provision.

Adult Bronchoesophageal Fistula Diagnosed on Computed Tomography.

Tracheoesophageal and bronchoesophageal fistulas are usually diagnosed early in life after an infant presents with difficulty feeding or recurrent pneumonias. These conditions rarely presents in adulthood. We report a case of a 59-year-old woman who presented with cough and recurrent pneumonias.

Comprehensive approach to automated assistive telemanagement for seniors in their home or residence-pilot program results.

A comprehensive pilot study was conducted to examine how remote senior monitoring of important vitals information and virtual nurse visits conducted remotely via videophone would improve seniors' adherence to care plan and enable them to remain in their homes longer. Recruitment of study individuals was conducted in the North Shore area of Chicago, Ill. Eleven seniors participated in this small scale study to keep scale issues controlled.