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Complementing randomized controlled trials, real-world evidence (RWE) from observational analyses can extend clinical insights in oncology. While healthcare stakeholders have published rigorous RWE frameworks and resources, a multidisciplinary think tank was established to further advance acceptance and use of RWE in treatment decision-making, with the focus on breast cancer (while recognizing relevance in oncology more broadly). Members discussed perceptions of RWE from a clinical perspective, across domains of data, methodology, and mindset, and "calls-to-action" for stakeholders. Agreement was reached on a primary "call-to-action," to develop clinically-relevant, patient-informed, real-world endpoints, and secondary "calls-to-action": establish a multidisciplinary consensus forum; publish examples of unique RWE value; build upon existing frameworks and resources; and tailor an approach for exhibiting utility to guideline bodies.
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http://dx.doi.org/10.1007/s12325-025-03201-y | DOI Listing |
Clin Transplant
September 2025
Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
Background: Liver transplantation is the definitive treatment for end-stage liver disease and some cancers. The use of livers from donors following pre-donation cardiac arrest (PDCA), especially with prolonged downtime duration, has been limited outside of the US due to fears over inferior outcomes from ischemic injury. However, PDCA may induce ischemic preconditioning, paradoxically improving post-transplant outcomes.
View Article and Find Full Text PDFWorld J Microbiol Biotechnol
September 2025
Department of Microbiology, University of Georgia, Athens, GA, 30602, USA.
While PGPB have historically been applied in agriculture, their formal recognition in the last century has driven intensive research into their role as sustainable tools for improving crop yield and stress tolerance. As they are primarily sourced from wild or native environments, the widespread enthusiasm has led to heightened expectations surrounding their potential, often based on the assumption that biological solutions are inherently safer and more effective than synthetic inputs. However, despite their popularity, increasing reports of inconsistent or limited performance under real-world, field conditions have raised critical questions about their credibility as biofertilizers and biocontrol agents.
View Article and Find Full Text PDFClin Infect Dis
September 2025
Epidemiology Informatics, Centre for Health Analytics, Melbourne Children's Campus, Parkville, Victoria, Australia.
Background: Following the introduction of a funded recombinant shingles (RZV, Shingrix®) vaccination program in ≥65 years in Australia, clinician reports of shingles presentations shortly after vaccination emerged. We investigated whether there was an increase in shingles risk immediately post RZV vaccination in South-eastern Australia.
Methods: Two independent datasets- a general practice dataset and a statewide linked dataset- were analysed separately using self-controlled case series analyses (SCCS) with 21-days post-vaccination as the risk window.
J Robot Surg
September 2025
Department of Orthopedic Surgery, Orthopedic and Rheumatology Institute, Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH, A4144195, USA.
Robotic-assisted total joint arthroplasty (RA-TJA) is projected to account for 70% of all arthroplasties by 2030, yet its economic value and operational efficiency have yet to be thoroughly synthesized. While early literature emphasized technical precision, evolving payment models and implementation costs have shifted focus toward cost-effectiveness and workflow integration. To evaluate the economic and institutional viability of RA-TJA by synthesizing available evidence on capital costs, perioperative expenses, learning curves, throughput, and long-term adoption trends.
View Article and Find Full Text PDFPharmacoepidemiol Drug Saf
September 2025
IQVIA, Real World Solutions, Durham, North Carolina, USA.
Background: The quality of real-world data (RWD) directly impacts the value of real-world evidence (RWE) generated for regulatory decision-making. Data owners and investigators must be prepared to provide documentation on data quality assessments to regulators when submitting secondary data for regulatory purposes. While robust feasibility is required to justify the relevance of a data source for a specific research question, the reliability of the data, including the chain of custody and data journey prior to reaching the end user, is of equal importance for drawing valid, meaningful conclusions.
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