Background: Risk-based decision making is increasingly recognized as key to support national blood policy makers and blood operators concerning the implementation of safety interventions, especially to address emerging infectious threats and new technology opportunities. There is an urgent need for practical decision support tools, especially for low- and middle-income countries that may not have the financial or technical capability to develop risk models. WHO supported the development of such a tool for blood safety. The tool enables users to perform both a quantitative Multi-Criteria Decision Assessment and a novel step-by-step qualitative assessment.
Study Design And Methods: This paper summarizes the content, functionalities, and added value of the new WHO tool. A fictitious case study of a safety intervention to reduce the risk of HIV transmission by transfusion was used to demonstrate the use and usefulness of the tool.
Results: Application of the tool highlighted strengths and weaknesses of both the quantitative and qualitative approaches. The quantitative approach facilitates assessment of the robustness of the decision but lacks nuances and interpretability especially when multiple constraints are taken into consideration. Conversely, while unable to provide an assessment of robustness, the step-by-step qualitative approach helps structuring the thought process and argumentation for a preferred intervention in a systematic manner.
Conclusion: The relative strengths and weaknesses of the quantitative and step-by-step qualitative approach to risk-based decision making are complementary and mutually enhancing. A combination of the two approaches is therefore advisable to support the selection of appropriate blood safety interventions for a particular setting.
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http://dx.doi.org/10.1111/trf.16231 | DOI Listing |
Gynecol Oncol Rep
February 2025
H. Lee Moffitt Cancer Center & Research Institute, Health Outcomes and Behavior, Tampa, FL, United States.
Background: The 2019 ASCCP Risk-Based Management Consensus Guidelines prefer expedited treatment, defined as proceeding to excisional treatment without first performing colposcopic biopsy, for patients with screening results indicating a high risk of cervical precancer. In this mixed methods study, we explored clinician attitudes toward expedited treatment.
Methods: In 2021, a national sample of 671 clinicians who performed colposcopy completed surveys; a subset (n = 41) of clinicians who performed colposcopy and/or directed patient treatment completed qualitative interviews.
Clin Pharmacol Ther
January 2025
Certara Predictive Technologies Division, Certara UK Limited, Sheffield, UK.
Understanding cytokine-related therapeutic protein-drug interactions (TP-DI) is crucial for effective medication management in conditions characterized by elevated inflammatory responses. Recent FDA and ICH guidelines highlight a systematic, risk-based approach for evaluating these interactions, emphasizing the need for a thorough mechanistic understanding of TP-DIs. This study integrates the physiologically based pharmacokinetic (PBPK) model for TP (specifically interleukin-6, IL-6) with small-molecule drug PBPK models to elucidate cytokine-related TP-DI mechanistically.
View Article and Find Full Text PDFAm J Sports Med
January 2025
Commons Clinic, Long Beach, California, USA.
Background: Orthopaedic surgeons play a critical role in ensuring the health and safety of professional athletes. Despite the privilege of treating elite athletes, there exists great financial exposure to individual physicians in the event of a malpractice lawsuit.
Hypothesis/purpose: The purpose of this study was to evaluate and model malpractice liability exposure of the sports medicine surgeon caring for athletes in the National Football League (NFL), Major League Baseball (MLB), and National Hockey League (NHL) with respect to player position and additional supplemental malpractice insurance needs.
Vaccines (Basel)
November 2024
Vaccine Research and Development, Pfizer Inc., Pearl River, NY 10965, USA.
Background/objectives: Respiratory syncytial virus (RSV) is the leading cause of severe respiratory disease in infants worldwide. Maternal immunization to protect younger infants is supported by evidence that virus-neutralizing antibodies, which are efficiently transferred across the placenta from mother to fetus, are a primary immune mediator of protection. In maternal RSV vaccine studies, estimates of correlates of protection are elusive because many factors of maternal-fetal immunobiology and disease characteristics must be considered for the estimates.
View Article and Find Full Text PDFCancers (Basel)
December 2024
Division of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.
Background: Early-phase clinical trials offer a unique opportunity for patients with cancer. These trials often mandate biopsies to collect tumor tissue for research purposes, requiring patients to undergo invasive procedures. Some trials mandate molecular prescreening, but the success of these analyses relies on the quality and quantity of the tested materials.
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