Benefit and risk of adding rivaroxaban in patients with coronary artery disease: A systematic review and meta‐analysis
Sign Up to like & getrecommendations! Published in 2020 at "Clinical Cardiology"
DOI: 10.1002/clc.23514
Abstract: Although the European Medicines Agency and the US Food and Drug Administration have, respectively, approved rivaroxaban for the prevention of recurrent major adverse cardiovascular events in patients with myocardial infarction and stable coronary artery disease,… read more here.
Keywords: risk adding; artery disease; coronary artery; benefit risk ... See more keywords
Added Benefit and Risk of an Additional Biopsy or Targeting With Contrast‐Enhanced Ultrasound for Patients With Renal Transplants
Sign Up to like & getrecommendations! Published in 2020 at "Journal of Ultrasound in Medicine"
DOI: 10.1002/jum.15544
Abstract: To determine whether renal transplant diagnoses substantially change when 2 biopsy sites are chosen and whether contrast‐enhanced ultrasound (CEUS) has value for targeting the second site. read more here.
Keywords: biopsy; added benefit; benefit risk; enhanced ultrasound ... See more keywords
Mapping benefit-risk decision-making processes and identifying decision points with the potential to include patient preference information throughout the medical product lifecycle
Sign Up to like & getrecommendations! Published in 2018 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.4629
Abstract: Mapping benefit-risk decision-making processes and identifying decision points with the potential to include patient preference information throughout the medical product lifecycle read more here.
Keywords: decision; making processes; risk decision; mapping benefit ... See more keywords
The utility of real‐world evidence for benefit‐risk assessment, communication, and evaluation of pharmaceuticals: Case studies
Sign Up to like & getrecommendations! Published in 2020 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.5167
Abstract: In recent years, novel types of real‐world evidence (RWE) have played a role in various decision‐making processes relating to medicinal products, including regulatory approval, patient access, health technology assessment, safety monitoring, clinical use, and post‐approval… read more here.
Keywords: real world; world evidence; risk; risk assessment ... See more keywords
A Bayesian approach for individual-level drug benefit-risk assessment.
Sign Up to like & getrecommendations! Published in 2019 at "Statistics in medicine"
DOI: 10.1002/sim.8166
Abstract: In existing benefit-risk assessment (BRA) methods, benefit and risk criteria are usually identified and defined separately based on aggregated clinical data and therefore ignore the individual-level differences as well as the association among the criteria.… read more here.
Keywords: risk assessment; benefit risk; individual level;
Benefit–risk assessment of commonly consumed fish species from South China Sea based on methyl mercury and DHA
Sign Up to like & getrecommendations! Published in 2019 at "Environmental Geochemistry and Health"
DOI: 10.1007/s10653-019-00254-1
Abstract: Even though a growing number of reports indicated favorable health effects with fish consumption, kinds of hazardous substances in fish were detected in fish and to be exceeded advisory limitation. Benefit–risk assessment of commonly consumed… read more here.
Keywords: risk; commonly consumed; fish species; benefit risk ... See more keywords
Quantitative benefit and risk assessment of cadmium and nutrient levels in Chinese mitten crab (Eriocheir sinensis)
Sign Up to like & getrecommendations! Published in 2020 at "Environmental Science and Pollution Research"
DOI: 10.1007/s11356-020-10977-9
Abstract: The use of Chinese mitten crabs for human consumption is controversial due to their uptake of heavy metals, such as cadmium (Cd). We developed a formula for quantification of benefit and risk assessment (hazard quotient)… read more here.
Keywords: risk; chinese mitten; benefit risk; cadmium ... See more keywords
Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists
Sign Up to like & getrecommendations! Published in 2019 at "Drug Safety"
DOI: 10.1007/s40264-019-00812-7
Abstract: The prevalence of obesity and related comorbidities is increasing worldwide. Furthermore, clinically meaningful body weight losses has proven difficult to achieve and especially to maintain through sustained lifestyle change in the form of diet and… read more here.
Keywords: weight loss; obesity drugs; benefit risk; receptor ... See more keywords
Patient Global Impression of Benefit–Risk (PGI-BR): Incorporating Patients’ Views of Clinical Benefit–Risk into Assessment of New Medicines
Sign Up to like & getrecommendations! Published in 2021 at "Drug Safety"
DOI: 10.1007/s40264-021-01079-7
Abstract: There is a need to understand how patients assess perceived benefits and risks of treatments. The study aimed to (i) elucidate how patients evaluate treatment experiences and (ii) develop a brief patient-reported outcome (PRO) instrument… read more here.
Keywords: medicine; benefit; risk assessment; benefit risk ... See more keywords
Toward a Framework for Benefit-Risk Assessment in Diagnostic Imaging: Identifying Scenario-specific Criteria.
Sign Up to like & getrecommendations! Published in 2017 at "Academic radiology"
DOI: 10.1016/j.acra.2017.02.002
Abstract: RATIONALE AND OBJECTIVES Diagnostic imaging has many effects and there is no common definition of value in diagnostic radiology. As benefit-risk trade-offs are rarely made explicit, it is not clear which framework is used in… read more here.
Keywords: radiology; diagnostic imaging; benefit risk; framework ... See more keywords
A new framework to address challenges in quantitative benefit-risk assessment for medical products.
Sign Up to like & getrecommendations! Published in 2020 at "Contemporary clinical trials"
DOI: 10.1016/j.cct.2020.106073
Abstract: In recent years, there has been a proliferation of regulatory and industry-wide initiatives on structured benefit-risk (BR) assessment. Examples of structured BR frameworks include the PrOACT-URL (Problem formulation, Objectives, Alternatives, Consequences, Trade-Offs, Uncertainties, Risk Attitude… read more here.
Keywords: framework; risk assessment; benefit risk; risk ... See more keywords