45 research outputs found
The Insertion and Management of External Ventricular Drains: An Evidence-Based Consensus Statement : A Statement for Healthcare Professionals from the Neurocritical Care Society.
External ventricular drains (EVDs) are commonly placed to monitor intracranial pressure and manage acute hydrocephalus in patients with a variety of intracranial pathologies. The indications for EVD insertion and their efficacy in the management of these various conditions have been previously addressed in guidelines published by the Brain Trauma Foundation, American Heart Association and combined committees of the American Association of Neurological Surgeons and the Congress of Neurological Surgeons. While it is well recognized that placement of an EVD may be a lifesaving intervention, the benefits can be offset by procedural and catheter-related complications, such as hemorrhage along the catheter tract, catheter malposition, and CSF infection. Despite their widespread use, there are a lack of high-quality data regarding the best methods for placement and management of EVDs to minimize these risks. Existing recommendations are frequently based on observational data from a single center and may be biased to the authors\u27 view. To address the need for a comprehensive set of evidence-based guidelines for EVD management, the Neurocritical Care Society organized a committee of experts in the fields of neurosurgery, neurology, neuroinfectious disease, critical care, pharmacotherapy, and nursing. The Committee generated clinical questions relevant to EVD placement and management. They developed recommendations based on a thorough literature review using the Grading of Recommendations Assessment, Development, and Evaluation system, with emphasis placed not only on the quality of the evidence, but also on the balance of benefits versus risks, patient values and preferences, and resource considerations
LB756 Patient-reported outcomes for sarecycline effectiveness in Acne Vulgaris in real-world settings: PROSES study protocol
Introduction: The detrimental psychosocial impact of acne vulgaris is well established. Patient-reported outcomes are needed to fully understand the psychosocial benefits of acne treatment. Sarecycline, a novel narrow-spectrum antibiotic, demonstrated efficacy, safety, and improvement in health-related quality of life (HRQOL) in clinical trials and is approved for treatment of moderate-to-severe acne. In 2020, a consensus panel generated a 10-question expert panel questionnaire (EPQ), which, along with the validated acne symptom and impact scale (ASIS), was considered a high-quality tool for real-world assessment of patient-reported HRQOL. The HRQOL benefits of sarecycline will be assessed using these instruments.
Methods: This single-group, prospective, 12-week cohort study is expected to enroll 300 patients (age, ≥9 years) with moderate-to-severe acne treated with sarecycline as part of routine care in up to 50 US community practices. The primary endpoint is patient-reported outcomes at week 12. At the baseline and week-12 visits, patients and caregivers of pediatric patients will complete the EPQ and ASIS. Additional endpoints include sarecycline effectiveness (success on investigator global assessment), satisfaction, safety, and tolerability.
Conclusions: This real-world study of sarecycline will be the first to use the most recent expert panel recommendations to evaluate HRQOL for patients with acne