PubMed Journals Articles About "Hold Workshop Structured Benefit Risk Assessment" RSS

11:33 EDT 26th September 2018 | BioPortfolio

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Showing "hold workshop structured benefit risk assessment" PubMed Articles 1–25 of 26,000+

Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis.

Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER)...

Confirmatory versus explorative endpoint analysis: Decision-making on the basis of evidence available from market authorization and early benefit assessment for oncology drugs.

The early benefit assessment of pharmaceuticals in Germany and their preceding market authorization pursue different objectives. This is reflected by the inclusion of varying confirmatory endpoints within the evaluation of oncology drugs in early benefit assessment versus market authorization, with both relying on the same evidence. Data from assessments up to July 2015 are used to estimate the impact of explorative in comparison to confirmatory endpoints on market authorization and early benefit assessment...

The role of structured Antenatal Risk Management (sARM) on experiences with antenatal care by vulnerable clients.

Vulnerable clients (i.e. clients reporting psychopathology, psychosocial problems, or substance use, and/or features of deprivation) represent a challenge in perinatal care, both in term of care process and outcome. Adhering to a structured care process (i.e. structured Antenatal Risk Management [sARM]) has shown to benefit professionals in supporting vulnerable clients, but its effect on client experiences is yet to be determined. As better processes are assumed to benefit outcome, we investigated the rela...

Scientific advances and challenges in safety evaluation of food packaging materials: Workshop proceedings.

Packaging is an indispensable component of the food manufacturing and food supply process. This scientific workshop was convened to bring together scientists from government, academia, and industry to discuss the state of the science regarding the safety of food packaging, prompted by rapidly advancing research to improve food packaging that continues to impact packaging technology, toxicology, exposure, risk assessment, and sustainability. The opening session focused on scientific challenges in the safety ...

Use of risk assessment instruments to predict violence in forensic psychiatric hospitals: a systematic review and meta-analysis.

Violent behaviour by forensic psychiatric inpatients is common. We aimed to systematically review the performance of structured risk assessment tools for violence in these settings.

Ethical considerations of researchers conducting pediatric clinical drug trials: a qualitative survey in two Belgian university children's hospitals.

There is a general consensus about the underlying theoretical ethical principles that ground the practice of pediatric clinical trials: scientific necessity, good risk/benefit ratio, minimized burden, and parental consent/child assent. However, these principles are so broadly construed that it is not always clear how they should be applied in clinical practice. We conducted a qualitative study at Ghent University Hospital and the hospital of the Dutch-speaking university of Brussels on how researchers weigh...

Decreasing the risk of SUDEP: Structured communication of risk factors for premature mortality in people with epilepsy.

Good practice guidelines highlight the importance of making people with epilepsy aware of the risk of premature mortality in epilepsy particularly due to Sudden Unexpected Death in Epilepsy (SUDEP). The SUDEP and Seizure Safety Checklist ("Checklist") is a structured risk communication tool used in UK clinics. It is not known if sharing structured information on risk factors allows individuals to reduce SUDEP and premature mortality risks.

Benefit, risk and cost of new oral anticoagulants and warfarin in atrial fibrillation; A multicriteria decision analysis.

Warfarin and new oral anticoagulants are effective in reducing stroke in atrial fibrillation; however, the benefits and risks rates in clinical trials show heterogeneity for each anticoagulant, and is unknown the cost influence on a model considering most of the treatment consequences. We designed a benefit-risk and cost assessment of oral anticoagulants.

The evaluation of three comorbidity indices in predicting postoperative complications and readmissions in pediatric urology.

The surgical comorbidity assessment is important for patient risk stratification, counseling, and research. In adults, risk assessment indices, such as the Charlson Co-morbidity Score (CCS) or Van Walraven Index (VWI), are well established. In pediatrics, however, risk assessment indices are scarce. Recently, a pediatric-specific risk assessment index, the Rhee index, was developed to discriminate mortality for pediatric general surgery patients. Currently, there is no validated risk assessment tool in pedi...

Analysis of Late AMNOG Benefit Assessments.

Since 2011, new drugs are assessed at the time of launch in Germany (AMNOG). Based on this early benefit assessment (EBA), drug prices are negotiated. At this time, the evidence base might be weak. A later benefit assessment (LBA) is not done on a regular basis except for selected drugs. Our objective was to analyze the impact of LBAs of drugs for the same indication.

Relative Bioavailability Risk Assessment: A Systematic Approach to Assessing In Vivo Risk Associated with CM&C related Changes.

Relative bioavailability (RBA) studies are often carried out to bridge changes made between drug products used for clinical studies. In this work we describe the development of a risk assessment tool that comprehensively and objectively assesses the risk of non-comparable in vivo performance associated with CM&C-related changes. The risk assessment tool is based on a risk grid that provides a quantitative context to facilitate discussions to determine the need for an in vivo RBA study. Relevant regulatory g...

Sex Offender Risk Assessment: Where Are We and Where Are We Going?

Risk assessment is one of the most ubiquitous tasks in the criminal justice system, informing virtually every decision made about offenders. This review, intended for researchers and practitioners, outlines some of the most important recent advances, emerging issues, and recommendations in sex offender risk assessment.

Analysis of the Risks and Benefits of New Chemical Entities Approved by the US Food and Drug Administration (FDA) and Subsequently Withdrawn From the US Market.

Benefit-risk evaluations of drugs have been conducted since the introduction of modern regulatory systems more than 50 years ago. Such judgments are typically made on the basis of qualitative or semiquantitative approaches, often without the aid of quantitative assessment methods, the latter having often been applied asymmetrically to place emphasis on benefit more so than harm. In an effort to preliminarily evaluate the utility of lives lost or saved, or quality-adjusted life-years (QALY) lost and gained a...

A framework to support risk assessment in hospitals.

A number of challenges have been identified with current risk assessment practice in hospitals, including: a lack of consultation with a sufficiently wide group of stakeholders; a lack of consistency and transparency; and insufficient risk assessment guidance. Consequently, risk assessment may not be fully effective as a means to ensure safety.

Ecofriendly nanotechnologies and nanomaterials for environmental applications: Key issue and consensus recommendations for sustainable and ecosafe nanoremediation.

The use of engineered nanomaterials (ENMs) for environmental remediation, known as nanoremediation, represents a challenging and innovative solution, ensuring a quick and efficient removal of pollutants from contaminated sites. Although the growing interest in nanotechnological solutions for pollution remediation, with significant economic investment worldwide, environmental and human risk assessment associated with the use of ENMs is still a matter of debate and nanoremediation is seen yet as an emerging t...

The Art of Cardiovascular Risk Assessment.

The authors would like to submit two corrections on the recently published manuscript, Art of Cardiovascular Risk Assessment. In section 4, the original sentence states: "However, the SCCT does not recommend use of a CAC score in low-risk patients with an ASCVD risk of < 10%." We would like to correct this to "Furthermore, the SCCT recommends consideration of a CAC score in those with a risk score of 5-20% and selectively in those with lower predicted risk who have a family history of premature ASCVD or oth...

DrawingOut - An innovative drawing workshop method to support the generation and dissemination of research findings.

A growing body of literature has explored the potential for arts-based methods to generate and disseminate research, particularly on sensitive or complex topics. This article presents DrawingOut, a metaphor-centred drawing workshop designed to collect visual and textual data about individuals' experiences of sensitive or taboo health experiences. The visual data, consisting of the artwork produced by participants, and the textual data, all conversations and discussions occurring during the workshop, can als...

Probabilistic Integrated Human Mixture Risk Assessment of Multiple Metals Through Seafood Consumption.

Inorganic arsenic (iAs), cadmium (Cd), lead (Pb), and methylmercury (MeHg) are toxic metals that cause substantial health concern and are present in various seafood items. This study linked probabilistic risk assessment to the interactive hazard index (HI ) approach to assess the human mixture risk posed by the dietary intake of iAs, Cd, Pb, and MeHg from seafood for different age populations, and joint toxic actions and toxic interactions among metals were also considered in the assessment. We found that, ...

Maintenance of Physical Function 1 Year After Exercise Intervention in At-Risk Older Adults: Follow-up From the LIFE Study.

Structured physical activity interventions delay the onset of disability for at-risk older adults. However, it is not known if at-risk older adults continue to participate in physical activity or maintain mobility benefits after cessation of structured intervention.

Primary prevention implantable cardioverter-defibrillator and opportunities for sudden cardiac death risk assessment in non-ischaemic cardiomyopathy.

Sudden cardiac death (SCD) accounts for approximately one-third of all deaths among patients with non-ischaemic cardiomyopathy (NICM). Implantable cardioverter-defibrillator (ICD) therapy has been the primary intervention for managing individuals at high risk for SCD. However, individual ICD trials in the NICM population have failed to demonstrate a mortality benefit with prophylactic ICD implantation. Current guidelines recommend ICD implantation in NICM patients with symptomatic heart failure and a left v...

The Interface of Pancreatic Cancer With Diabetes, Obesity, and Inflammation: Research Gaps and Opportunities: Summary of a National Institute of Diabetes and Digestive and Kidney Diseases Workshop.

A workshop on "The Interface of Pancreatic Cancer with Diabetes, Obesity, and Inflammation: Research Gaps and Opportunities" was held by the National Institute of Diabetes and Digestive and Kidney Diseases on October 12, 2017. The purpose of the workshop was to explore the relationship and possible mechanisms of the increased risk of pancreatic ductal adenocarcinoma (PDAC) related to diabetes, the role of altered intracellular energy metabolism in PDAC, the mechanisms and biomarkers of diabetes caused by PD...

Consent and labeling in the use of infectious risk donor kidneys: a response to "Information Overload.

We thank Singh et al for their interest in our work on the survival benefit conferred by increased infectious risk kidneys (IRD) (1). We agree that our findings of substantial benefit and elevated discard rates of IRD kidneys, coupled with existing literature on their low infectious risk, support broader utilization of these so-labeled kidneys. Physicians and patients considering these offers can also turn to our risk calculator ( to quantify the personalized survival benefit o...

Combining ecosystem services assessment with structured decision making to support ecological restoration planning.

Accounting for ecosystem services in environmental decision making is an emerging research topic. Modern frameworks for ecosystem services assessment emphasize evaluating the social benefits of ecosystems, in terms of who benefits and by how much, to aid in comparing multiple courses of action. Structured methods that use decision analytic-approaches are emerging for the practice of ecological restoration. In this article, we combine ecosystem services assessment with structured decision making to estimate ...

Statin Eligibility in Primary Prevention: From a Risk-Based Strategy to a Personalized Approach Based on the Predicted Benefit.

Guidelines have recommended statin initiation based on the absolute cardiovascular risk. We tested the hypothesis that a strategy based on the predicted cardiovascular benefit, compared with the risk-based approach, modifies statin eligibility and the estimated benefit in a population in primary cardiovascular prevention. The study included 16,008 subjects (48 ± 6 years, 73% men) with low-density lipoprotein cholesterol levels of 70 to 

Benefit-risk analysis for foods (BRAFO): Evaluation of exposure to dietary nitrates.

Dietary nitrate has been associated with health benefits as well as potential risks, thus presenting a paradox for consumers and health professionals. To address the issue, we applied the Benefit-Risk Analysis for Foods (BRAFO) framework to evaluate dietary exposure to nitrate by considering how the risks and benefits might vary under the reference scenario of the acceptable daily intake (ADI) set forth by JECFA (3.7 mg/kg-day), or under an alternative scenario of a higher ADI (independently developed her...

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