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04:17 EST 22nd February 2018 | BioPortfolio

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

Benefit Assessment for Examination and Treatment Methods with Medical Devices of High Hisk: Trade-off between Patient Benefit, Evidence and Access.

The lately inured § 137 h SGB V aims to assess the benefit of new examination and treatment methods with medical devices of class IIb and III. In the future, the decision on the reimbursement eligibility will be marked by high requirements in terms of documentation of benefits and harm. The objective of benefit assessment is the operationalization of benefit to patients. A comparative determination of benefit enables rational decision by regulatory authorities. The process of benefit assessment should guar...

Dermal absorption for pesticide health risk assessment: Harmonization of study design and data reporting for North American regulatory submissions.

Although an internationally-adopted in vitro dermal absorption test guideline is available (OECD Test Guideline 428), the replacement of the in vivo approach in North America for pesticide formulations has not occurred due to concern over the reliability and consistency of the in vitro results. A 2012 workshop convened a panel of experts in the conduct of in vitro studies used for pesticide risk assessment, together with North American regulators, to examine techniques for in vitro dermal absorption testing...

Current and future cardiovascular disease risk assessment in the European Union: an international comparative study.

Risk assessment is central to primary prevention of cardiovascular disease (CVD), but there remains a need to better understand the use of evidence-based interventions in practice. This study examines: (i) the policies and guidelines for risk assessment in Europe, (ii) the use of risk assessment tools in clinical practice and (iii) the barriers to, and facilitators of, risk assessment.

Low-dose aspirin for primary prevention of cardiovascular events in patients with diabetes: Benefit or risk?

Primary prevention aims to avert the onset of cardiovascular disease (CVD) by targeting its natural causes and risk factors; secondary prevention includes strategies and therapies that address preclinical or clinical evidence of CVD progression. The value of aspirin for primary CVD prevention is controversial because of increased bleeding, which may offset the overall modest benefits in patients with no overt CVD. In contrast, the benefits of aspirin for secondary prevention have been repeatedly and convinc...

The inappropriate use of risk-benefit analysis in the risk assessment of experimental trauma-focused research.

Facilitating peer based learning through summative assessment - An adaptation of the Objective Structured Clinical Assessment tool for the blended learning environment.

Adapting a course from face to face to blended delivery necessitates that assessments are modified accordingly. In Australia the Objective Structured Clinical Assessment tool, as a derivative from the Objective Structured Clinical Examination, has been used in the face-to-face delivery mode as a formative or summative assessment tool in medicine and nursing since 1990. The Objective Structured Clinical Assessment has been used at Charles Darwin University to assess nursing students' simulated clinical skill...

Procedure to select test organisms for environmental risk assessment of genetically modified crops in aquatic systems.

For a long time, the environmental risk assessment (ERA) of genetically modified (GM) crops mainly focused on terrestrial ecosystems. This changed when it was scientifically established that aquatic ecosystems are exposed to GM crop residues which may negatively affect aquatic species. To assist the risk assessment process, we present a tool to identify ecologically relevant species usable in tiered testing prior to authorization or for biological monitoring in the field. The tool is derived from a selectio...

The role of satellite remote sensing in structured ecosystem risk assessments.

The current set of global conservation targets requires methods for monitoring the changing status of ecosystems. Protocols for ecosystem risk assessment are uniquely suited to this task, providing objective syntheses of a wide range of data to estimate the likelihood of ecosystem collapse. Satellite remote sensing can deliver ecologically relevant, long-term datasets suitable for analysing changes in ecosystem area, structure and function at temporal and spatial scales relevant to risk assessment protocols...

Development and Internal Validation of the Abdominoplasty Risk Calculator.

Risk calculators are an emerging tool that provide granular, individualized risk estimation. Presently, there is a paucity of risk calculators specific to plastic surgery. Abdominoplasty is a popular plastic surgery procedure associated with moderate risks of complications, such as surgical-site infection and dehiscence, and would benefit from the ability to provide patients with accurate, personalized risk assessment.

The dilemmas of science for policy: Scientific evidence and the consequences of regulatory options in risk and benefit assessment.

Why Suicide Risk Assessment Still Matters.

Both public awareness of suicide and professional efforts directed at suicide prevention have increased considerably in recent years. Unfortunately, rates of death by suicide have remained relatively stable over the past decade despite these enhanced efforts. Some have argued that "suicide risk assessment doesn't work" and have called into question the utility of devoting clinical time and energy to risk assessment. In this column, the authors first present an overview of the argument against suicide risk a...

Current indication for hematopoietic cell transplantation in adults.

With advances in transplantation technology and supportive care practices, hematopoietic cell transplantation (HCT) has become relatively safer and the applicability of HCT continues to expand. However, appropriate selection of transplant candidates remains challenging. Identifying adult patients who may benefit from HCT involves consideration of patient and disease factors, including overall health, prior therapies, age, comorbidity, and disease/disease risk. The eligibility of transplants should be decide...

Predicting child maltreatment: A meta-analysis of the predictive validity of risk assessment instruments.

Risk assessment is crucial in preventing child maltreatment since it can identify high-risk cases in need of child protection intervention. Despite widespread use of risk assessment instruments in child welfare, it is unknown how well these instruments predict maltreatment and what instrument characteristics are associated with higher levels of predictive validity. Therefore, a multilevel meta-analysis was conducted to examine the predictive accuracy of (characteristics of) risk assessment instruments. A li...

Screening for Lung Cancer: Current Status.

The evidence for the benefit and risks of lung cancer screening is based on a single large randomised controlled trial that showed a significant reduction in lung cancer mortality among lung cancer patients in the CT screening group compared to the control group. However, there are significant risks to the proven benefit. The large and unresolved problem in CT screening for lung cancer is the high rate of false positive findings. Further diagnostic work-up of these findings often requires invasive procedure...

The 53rd North American Chemical Residue Workshop.

The 53rd North American Chemical Residue Workshop was held in July 2016. This is a brief review of the workshop including the awarding of the 2nd NACRW Excellence award to Dr. Andre de Kok. It is also an introduction to a special issue of the Journal of Agricultural and Food Chemistry that presents manuscripts of papers presented at that workshop.

Structured reporting platform improves CAD-RADS assessment.

Structured reporting in cardiac imaging is strongly encouraged to improve quality through consistency. The Coronary Artery Disease - Reporting and Data System (CAD-RADS) was recently introduced to facilitate interdisciplinary communication of coronary CT angiography (CTA) results. We aimed to assess the agreement between manual and automated CAD-RADS classification using a structured reporting platform.


This paper provides summary of the 8th Conference on Protection against Radon at Home and at Work and 13th Workshop on the Geological Aspects of Radon Risk Mapping held in September 2016 in Prague, Czech Republic.

Multicriteria Decision Framework for Cybersecurity Risk Assessment and Management.

Risk assessors and managers face many difficult challenges related to novel cyber systems. Among these challenges are the constantly changing nature of cyber systems caused by technical advances, their distribution across the physical, information, and sociocognitive domains, and the complex network structures often including thousands of nodes. Here, we review probabilistic and risk-based decision-making techniques applied to cyber systems and conclude that existing approaches typically do not address all ...

Mars science laboratory radiation assessment detector (MSL/RAD) modeling workshop proceedings.

Developing a caries risk registry to support caries risk assessment and management for children: A quality improvement initiative.

Health registries are commonly used in medicine to support public health activities and are increasingly used in quality improvement (QI) initiatives. Illustrations of dental registries and their QI applications are lacking. Within dentistry, caries risk assessment implementation and documentation are vital to optimal patient care. The purpose of this article is to describe the processes used to develop a caries risk assessment registry as a QI initiative to support clinical caries risk assessment, caries p...

Advantages and challenges associated with implementing an ecosystem services approach to ecological risk assessment for chemicals.

The ecosystem services (ES) approach is gaining broad interest in regulatory and policy arenas for use in landscape management and ecological risk assessment. It has the potential to bring greater ecological relevance to the setting of environmental protection goals and to the assessment of the ecological risk posed by chemicals. A workshop, organised under the auspices of the Society of Environmental Toxicology and Chemistry Europe, brought together scientific experts from European regulatory authorities, ...

Risk and surrogate benefit for pediatric Phase I trials in oncology: A systematic review with meta-analysis.

Pediatric Phase I cancer trials are critical for establishing the safety and dosing of anti-cancer treatments in children. Their implementation, however, must contend with the rarity of many pediatric cancers and limits on allowable risk in minors. The aim of this study is to describe the risk and benefit for pediatric cancer Phase I trials.

Benefit-risk communication in paediatric imaging: What do referring physicians, radiographers and radiologists think, say and do?

To assess how referrers and practitioners disclose benefit-risk information about medical imaging examinations to paediatric patients and their parents/guardians; to gauge their confidence in doing so; and to seek their opinion about who is responsible for disclosing such information.

A Web-Based System for Bayesian Benchmark Dose Estimation.

Benchmark dose (BMD) modeling is an important step in human health risk assessment and is used as the default approach to identify the point of departure for risk assessment. A probabilistic framework for dose-response assessment has been proposed and advocated by various institutions and organizations; therefore, a reliable tool is needed to provide distributional estimates for BMD and other important quantities in dose-response assessment.

Quantum chemistry in environmental pesticide risk assessment.

The scientific community and regulatory bodies worldwide, currently promote the development of non-experimental tests that produce reliable data for pesticide risk assessment. The use of standard quantum chemistry methods could allow the development of tools to perform a first screening of compounds to be considered for the experimental studies, improving the risk assessment. This fact results in a better distribution of resources and in better planning, allowing a more exhaustive study of the pesticides an...

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