Risk-based Decision-making Framework Research Articles

Optimal malarial screening strategy in Australian blood donors: A cost-effectiveness analysis.

The risk of transfusion-transmitted malaria (TTM) infections is extremely low in Australia, and the cost-effectiveness of the current screening strategy has not been assessed. This study aims to conduct a cost-effectiveness analysis of different malaria screening strategies in blood donors as part of the risk-based decision-making framework. A decision tree model was developed to assess the cost-effectiveness of five alternative malaria screening strategies from a healthcare sector perspective. Screening strategies combining total or partial removal of malaria testing with different deferral periods were considered. The probabilities of developing severe and uncomplicated TTM were based on a literature review of cases in non-endemic areas since 2000. The health outcomes were quantified using disability-adjusted life years. The costs of non-returning donors due to deferral were also included. Deterministic and probabilistic sensitivity analyses were conducted to account for data uncertainty. The residual risks for all strategies were so low that the costs, mortality and morbidity associated with TTM are almost negligible. The overall costs were predominantly influenced by the costs of non-returning blood donors. As a result, removal of malaria testing and applying a 28-day deferral for at-risk donors were the least costly and most cost-effective of all the options considered. The current screening strategy for malaria in blood donors in Australia is not an efficient use of healthcare resources. Partial or total removal of malaria testing would bring significant cost savings without significantly compromising blood safety.

Risk-Based Decision-Making Framework for Implementation of Collaboration and Integration Strategies

Risk-Based Decision-Making Framework for Implementation of Collaboration and Integration Strategies

How donor selection criteria can be evaluated with limited scientific evidence: lessons learned from the TRANSPOSE project.

Donor selection criteria (DSC) are a vital link in the chain of supply of Substances of Human Origin (SoHO) but are also subject to controversy and differences of opinion. Traditionally, DSC have been based on application of the precautionary principle. From 2017 to 2020, TRANSPOSE (TRANSfusion and transplantation PrOtection and SElection of donors), a European research project, aimed to identify discrepancies between current DSC by proposing a standardized risk assessment method for all SoHO (solid organs excluded) and all levels of evidence. The current DSC were assessed using a modified risk assessment method based on the Alliance of Blood Operators' Risk-based decision-making framework for blood safety. It was found that with limited or diverging scientific evidence, it was difficult to reach consensus and an international standardized method for decision-making was lacking. Furthermore, participants found it hard to disregard their local guidelines when providing expert opinion, which resulted in substantial influence on the consensus-based decision-making process. While the field of donation-safety research is expanding rapidly, there is an urgent need to formalize the decision-making process regarding DSC. This includes the need for standardized methods to increase transparency in the international decision-making process and to ensure that this is performed consistently. Our framework provides an easy-to-implement approach for standardizing risk assessments, especially in the context of limited scientific evidence.

A risk‐based decision‐making framework for blood safety: what's the case for Zika?

Risk‐based decision‐making (RBDM) is a systematic approach to decision‐making that strives to minimize risk, optimize outcomes and prioritize resources for maximum good. Such is achieved by weighing all the factors that influence policy for a given threat, drawing on the best available scientific data, engaging key stakeholders, while still considering the complex interplay of ethics, social values, politics, economics, culture and historical precedent that argue for or against intervention. In the context of blood transfusion safety, attention to RBDM stems from a growing awareness that the current paradigm of ‘safety at any cost’ is unsustainable and unbalanced. By contrast, RBDM emphasizes proportionality and encourages review of decisions as new data emerge. Zika virus (ZIKV), a formerly obscure mosquito‐borne flavivirus, emerged rapidly in 2015, spurring an international public health emergency. The mandatory adoption of laboratory‐based blood donor screening for ZIKV in the United States (US) in 2016 remains contentious. Clinical cases of transfusion‐transmitted ZIKV infection have never been reported, and four years after the emergence of ZIKV in the Americas, the pandemic has waned, suggesting that the donor screening for ZIKV is high cost yet of questionable benefit. The US response to ZIKV offers an illustrative case study of the challenges surrounding intervention to protect the blood supply from emerging pathogens, and how an RBDM framework might help to guide policy. However, careful assessment (i.e. RBDM) alone does not guarantee a desirable outcome. Rather, risk‐tolerance in a given setting should not be understated.

Hepatitis E Virus Infection in Blood Donors and Risk to Patients in the United States and Canada.

Hepatitis E virus (HEV) is the most common cause of acute hepatitis worldwide including large water-borne outbreaks, zoonotic infections and transfusion transmissions. Several countries have initiated or are considering blood donor screening in response to high HEV-RNA donation prevalence leading to transfusion-transmission risk. Because HEV transmission is more common through food sources, the efficacy of blood donor screening alone may be limited. HEV-nucleic acids in 101 489 blood donations in the United States and Canada were studied. A risk-based decision-making framework was used to evaluate the quantitative risks and cost-benefit of HEV-blood donation screening in Canada comparing three scenarios: no screening, screening blood for all transfused patients or screening blood for only those at greatest risk. HEV-RNA prevalence in the United States was one per 16 908 (95% confidence interval [CI], 1:5786-1:81987), whereas Canadian HEV-RNA prevalence was one per 4615 (95% CI, 1:2579-1:9244). Although 4-fold greater, Canadian HEV-RNA prevalence was not significantly higher than in the United States. Viral loads ranged from 20 to 3080 international units per mL; all successfully typed infections were genotype 3. No HEV-RNA false-positive donations were identified for 100 percent specificity. Without donation screening, heart and lung transplant recipients had the greatest HEV-infection risk (1:366962) versus kidney transplant recipients with the lowest (1:2.8 million) at costs of $225 546 to $561 810 per quality-adjusted life-year (QALY) gained for partial or universal screening, respectively. Higher cost per QALY would be expected in the United States. Thus, HEV prevalence in North America is lower than in countries performing blood donation screening, and if implemented, is projected to be costly under any scenario.

Health economic implications of testing blood donors in South Africa for HTLV 1 & 2 infection.

Currently, HTLV screening is not performed in South Africa (SA). This report describes an economic assessment (budget impact and cost-effectiveness) of implementing different HTLV screening strategies. A modified version of the Alliance of Blood Operators risk-based decision-making framework was used to assess the risk and consequences of HTLV in the blood supply in SA. We developed a deterministic model of the cost and consequences of four screening strategies: none, universal, all donors once and first time donors only assuming a transfusion-transmission (TT) efficiency of 10% and a manifestation of clinical disease of 6%. Unscreened blood results in 3·55 symptomatic TT-HTLV cases and a total healthcare cost of Rand (R)3446950 (US Dollars (USD)229800) annually. Universal screening would cost R24000000 (USD1600000) per annum and prevent 3·54 (99·8%) symptomatic TT-HTLV cases in the first year and 0·55 (98·4%) symptomatic TT-HTLV cases in the second year at a cost per TT-HTLV prevented of R6780000 (USD450000) in year one and R43254000 (USD2890000) in year two. Screening all donors once would cost R16,200,000 (USD1080000) or R4600000 (USD306000) per symptomatic TT-HTLV infection prevented in year one. Total costs decrease to R5100000 (USD340000) in year 2 but the cost per TT-HTLV prevented increases to R10700000 (USD713333). This analysis contributed to the decision not to implement HTLV screening as the healthcare budget and particularly the budget for blood transfusion in SA is insufficient to provide appropriate treatment. Arguably, available resources can be more efficiently utilized in other healthcare programs.

Malaria blood safety policy in five non-endemic countries: a retrospective comparison through the lens of the ABO risk-based decision-making framework.

In non-endemic countries, malaria risk is addressed by selectively testing or deferring at-risk donors. These policy decisions were made using a variety of decision-making frameworks prior to the development of the Alliance of Blood Operators Risk Based Decision-Making Framework. It is unclear whether the range of items assessed in the decision-making process would be increased if the Framework were used. We compared assessments considered in France, England and Australia for decisions to implement selective testing, plus donor selection criteria (Canada and the USA included) with those recommended by the Framework. Elements of the Framework were identified: the intervention, safety threat, availability threat, donor impact, financial implications, risk communication, stakeholder and regulatory aspects. Decisions about selective testing and donor selection criteria were analysed separately. Assessments were compared against elements of the Framework and the level of concern for considerations rated. Sufficiency of the blood supply (plus safety in France) were the drivers for selective testing; main trade-offs were high operational impact and cost. In three donor criteria examples, transfusion-transmitted malaria cases prompted the change. Social concerns were high in France and Australia, political/regulatory concerns influenced decisions in France, Australia and Canada, while sufficiency was a consideration in Canada and the USA. Decision trade-offs involved moderate operational impact. The assessments considered in each country were generally consistent with the assessments recommended by the Framework. When data supported quantified risk assessment, safety and operational feasibility had the greatest weight. When risk was not well defined, contextual factors such as social and political concern had greater weight.

Large Occupational Accidents Data Analysis with a Coupled Unsupervised Algorithm: The S.O.M. K-Means Method. An Application to the Wood Industry

Data on occupational accidents are usually stored in large databases by worker compensation authorities, and by the safety and prevention teams of companies. An analysis of these databases can play an important role in the prevention of accidents and the reduction of risks, but it can be a complex procedure because of the dimensions and complexity of such databases. The SKM (SOM K-Means) method, a two-level clustering system, made up of SOM (Self Organizing Map) and K-Means clustering, has obtained positive results in identifying the dynamics of critical accidents by referring to a database of 1200 occupational accidents that had occurred in the wood industry. The present research has been conducted to validate the recently presented SKM methodology through the analysis of a larger data set of more than 4000 occupational accidents that occurred in Piedmont (Italy), between 2006 and 2013. This work has partitioned the accidents into groups of different accident dynamics families and has quantified the severity and frequency of occurrence of these accidents. The obtained information may be of help to Company Managers and National Authorities to better address preventive measures and policies concerning the clusters that have been identified as being the most critical within a risk-based decision-making framework.

Risk-based decision making in transfusion medicine.

Formal processes to assess risk are well established in numerous areas of society including the environment, transportation, energy and food production sectors as well as some areas of health care such as new drugs or other therapeutic goods. However, these processes and their associated frameworks have only recently come to be used to make decisions in blood transfusion practice or in blood system policy development. This review describes the evolution of the use of risk-based decision making and discusses the elements that should be considered in its application to blood system issues. Following the identification and characterization of the risk, a structured process is undertaken to assess the magnitude of the risk and the level of risk reduction that can reasonably be achieved in the context of the complexity of the risk management action proposed and its cost. Inputs must be sought from appropriate subject matter experts, but also from those who can consider issues of ethics and social values. Engagement of the public is an essential step. Proposed interventions should be assessed for their likelihood of mitigating the risk and the proportional resource allocation in comparison with similar risks to the blood system or health system. Examples are provided of how a risk-based decision-making framework is used to address identified risks in the blood system.

A Decision Framework for Managing the Risk of Terrorist Threats at Rail Stations Interconnected with Airports

This paper highlights a risk-based decision-making framework on a basis of probabilistic risk assessment (PRA). Its aim is to enable stakeholders of transport infrastructures to systematically and effectively allocate their limited resources and consequently improve resilience when facing the potential risk of a terrorist attack. The potential risk of a terrorist attack affects the inter-operation of transportation infrastructures including airports and rail stations, the regional economy, and imposes additional costs of security or any countermeasures. This novel framework is thus established in order to model the security system, to consider a multitude of threat scenarios, and to assess the decisions and choices taken by the aggressors during various stages of their attack. The framework has capability to identify the state of partial neutralization, which reveals the losses incurred when the terrorist could not reach the primary target. In this study, an underground railway station interconnected to an international airport has been used as a case study to demonstrate the effectiveness of this novel framework. By the rigorous assessment of potential losses during a variety of threat scenarios, four countermeasures that could minimise losses are proposed: screening of passengers by observation techniques (SPOT), a surveillance system, increase of the cargo screening rate, and blast-resistant cargo containers. The cost and efficiency assessment is employed to determine the most suitable countermeasures when the value of the security measures equal their cost. Note that ongoing research is still needed to establish better countermeasures since there is no end to the creativity of terrorists. The new technology, such as wireless sensors, will play an important role in the security system in the future. In particular, this study will help insurance and rail industries to model and manage risk profiles at critical infrastructure.

Assessing the risk of Babesia to the United States blood supply using a risk-based decision-making approach: Report of AABB's Ad Hoc Babesia Policy Working Group (original report).

Recognizing the increasing threat of transfusion-transmitted babesiosis to the US blood supply, the AABB Board of Directors tasked an Ad Hoc Babesia Policy Working Group (the Working Group) to use the Alliance of Blood Operators' risk-based decision-making (RBDM) framework to assess the risks and benefits of introducing Babesia donation testing in the United States. The regional nature of the Babesia microti risk added complexity to the RBDM assessment because of the unique operational and financial considerations for operators and hospitals located in endemic states. Therefore, the assessment considered safety, product availability, sector sustainability, and technology availability. After assessing safety risk, economic and operational impact, reimbursement equity, ethical considerations, and stakeholder feedback from two consultations, the Working Group concluded that a regional approach to donor screening in endemic states was appropriate because it applied the intervention where the risk was highest and appropriately allocated cost to the risk. Nucleic acid testing using a ribosomal RNA template was the recommended intervention because it was the most cost-effective, resulted in no wasted units, and captured similar numbers of infections as antibody plus DNA-based polymerase chain reaction. The current model for blood reimbursement was maintained but AABB was encouraged to facilitate collection of data to identify threats to sector sustainability in endemic states. Babesia expansion was acknowledged with a mechanism to regularly reevaluate what are "endemic states." Finally, given that public awareness of the Babesia threat is the first line of defense, AABB should work with appropriate agencies for general education about the health risk from B. microti.

Reconsideration of blood donation testing strategy for human T-cell lymphotropic virus in Australia.

Universal testing of blood donations for human T-cell lymphotropic virus (HTLV) in Australia may no longer be appropriate given the low prevalence of HTLV infection and the mitigating effect of universal leucodepletion for cellular components. This study aimed to determine the most appropriate HTLV testing strategy using the Risk-Based Decision-Making Framework for Blood Safety. The risk of HTLV transfusion-transmission using three testing strategies (universal, new-donor and no testing) and cost-effectiveness of the first two strategies were assessed using adaptations of published mathematical models. The overall prevalence for 2004-2014 was three HTLV-positives per million donations. It was estimated that annually, universal testing incurred a cost of approximately AUD $3 million and prevented 83 HTLV-positive cellular components from being issued, and new-donor testing cost approximately $225000 and prevented 81 components. The number of cases of transfusion-transmitted HTLV and HTLV-associated disease prevented per year by universal and new-donor testing was essentially equivalent. According to preset risk thresholds, the risk of transfusion-transmission was negligible for universal and new-donor testing, and minimal without testing. Transfusion-transmission of HTLV is a minimal risk in Australia even without testing. However, any revision of testing strategy must consider not only risk and cost-effectiveness, but also stakeholder, ethical and regulatory perspectives. Considering all relevant criteria, new-donor testing is judged the optimal strategy because it is able to achieve almost the same outcomes as universal testing, at a fraction of the cost.

Risk‐based decision making and ethical considerations in donor compensation for plasma‐derived medicinal products

Risk‐based decision making and ethical considerations in donor compensation for plasma‐derived medicinal products

Optimal risk-based strategy of distributed generation-owning retailer in the day-ahead electricity market: Chance constraint optimization approach

This paper presents a risk-based decision-making framework for the Distributed Generation (DG)-owning retailer to determine the optimal participation level in the forward and the day-ahead electricity markets, as well as the optimal scheduling of DG units. The energy price in the day-ahead market is very volatile and varies every hour. Also, unpredicted failures of DG units may impose a great financial loss on the retailer. Therefore, the retailer has to evaluate the effects of uncertain parameters to hedge the financial loss. In this paper, the financial risk associated with the uncertain prices is evaluated using the chance constraint optimization method. The normal density function is applied to model the probabilistic realizations of uncertain prices, and scenarios are generated via the scenario tree technique. Moreover, the availability of generation units is modeled by the availability probability. The proposed risk-based framework allows the retailer to determine the optimal strategy at the given risk level. The objective-function of the presented model is based on maximizing the expected profit in a way that ensures the specific profit constraint will be satisfied at the operation period with a defined probability. The performance and efficiency of the presented decision-making framework are analyzed on the sample DG-owning retailer, and the optimal framework is simulated under different risk levels.

Risk-based decision-making framework for the selection of sediment dredging option

The aim of this study was to develop a risk-based decision-making framework for the selection of sediment dredging option. Descriptions using case studies of the newly integrated, holistic and staged framework were followed. The first stage utilized the historical dredging monitoring data and the contamination level in media data into Ecological Risk Assessment phases, which have been altered for benefits in cost, time and simplicity. How Multi-Criteria Decision Analysis (MCDA) can be used to analyze and prioritize dredging areas based on environmental, socio-economic and managerial criteria was described for the next stage. The results from MCDA will be integrated into Ecological Risk Assessment to characterize the degree of contamination in the prioritized areas. The last stage was later described using these findings and analyzed using MCDA, in order to identify the best sediment dredging option, accounting for the economic, environmental and technical aspects of dredging, which is beneficial for dredging and sediment management industries.

A flood risk assessment for the City of Chilliwack on the Fraser River, British Columbia, Canada

ABSTRACTFlood hazard management in Canada is predicated on an event of arbitrary return period – the ‘design flood’, which on the Fraser River is the flood of record, with an estimated return period of 500 years. Recent studies have demonstrated that the existing dikes will not contain design flood levels, in a location where the potential consequences of flooding have increased exponentially during the past century. This suggests that a hazard-based approach is questionable for effective flood management. A pilot flood risk assessment was completed for the City of Chilliwack, 80 km east of Vancouver. We assessed direct and indirect economic losses for three hypothetical dike breach scenarios for flood return periods from 100 to 1000 years. We estimate that total losses would exceed CND $1 billion (€720 million) for the flood scenarios examined, not including intangibles such as emotional and cultural losses, environmental contamination, or changes in the quality and abundance of aquatic and terrestrial habitat. The study concludes with recommendations that would lead to a risk-based decision-making framework for flood mitigation design and emergency preparedness.

Development of risk-based air quality management strategies under impacts of climate change

Climate change is forecast to adversely affect air quality through perturbations in meteorological conditions, photochemical reactions, and precursor emissions. To protect the environment and human health from air pollution, there is an increasing recognition of the necessity of developing effective air quality management strategies under the impacts of climate change. This paper presents a framework for developing risk-based air quality management strategies that can help policy makers improve their decision-making processes in response to current and future climate change about 30–50 years from now. Development of air quality management strategies under the impacts of climate change is fundamentally a risk assessment and risk management process involving four steps: (1) assessment of the impacts of climate change and associated uncertainties; (2) determination of air quality targets; (3) selections of potential air quality management options; and (4) identification of preferred air quality management strategies that minimize control costs, maximize benefits, or limit the adverse effects of climate change on air quality when considering the scarcity of resources. The main challenge relates to the level of uncertainties associated with climate change forecasts and advancements in future control measures, since they will significantly affect the risk assessment results and development of effective air quality management plans. The concept presented in this paper can help decision makers make appropriate responses to climate change, since it provides an integrated approach for climate risk assessment and management when developing air quality management strategies. Implications: Development of climate-responsive air quality management strategies is fundamentally a risk assessment and risk management process. The risk assessment process includes quantification of climate change impacts on air quality and associated uncertainties. Risk management for air quality under the impacts of climate change includes determination of air quality targets, selections of potential management options, and identification of effective air quality management strategies through decision-making models. The risk-based decision-making framework can also be applied to develop climate-responsive management strategies for the other environmental dimensions and assess costs and benefits of future environmental management policies.

The [R]Evolving Relationship Between Risk Assessment and Risk Management

In Science and Decisions: Advancing Risk Assessment, the National Research Council recommends improvements in the U.S. Environmental Protection Agency's approach to risk assessment. The recommendations aim to increase the utility of these assessments, embedding them within a new risk-based decision-making framework. The framework involves first identifying the problem and possible options for addressing it, conducting related analyses, then reviewing the results and making the risk management decision. Experience with longstanding requirements for regulatory impact analysis provides insights into the implementation of this framework. First, neither the Science and Decisions framework nor the framework for regulatory impact analysis should be viewed as a static or linear process, where each step is completed before moving on to the next. Risk management options are best evaluated through an iterative and integrative procedure. The extent to which a hazard has been previously studied will strongly influence analysts' ability to identify options prior to conducting formal analyses, and these options will be altered and refined as the analysis progresses. Second, experience with regulatory impact analysis suggests that legal and political constraints may limit the range of options assessed, contrary to both existing guidance for regulatory impact analysis and the Science and Decisions recommendations. Analysts will need to work creatively to broaden the range of options considered. Finally, the usefulness of regulatory impact analysis has been significantly hampered by the inability to quantify many health impacts of concern, suggesting that the scientific improvements offered within Science and Decisions will fill an crucial research gap.

The Decision to Adopt Evidence-Based and Other Innovative Mental Health Practices: Risky Business?

A risk-based decision-making framework was used to examine the decision to adopt innovative mental health practices, including both evidence-based and other research-guided practices. Seventy-eight projects involving decisions to adopt one of four innovative mental health practices were the focus of this study. Key informants with direct knowledge about the adoption decision provided data for hypothesis testing. As predicted, the propensity to adopt an innovative practice-as measured by decision stage-was negatively related to the perceived risk of adopting the practice, positively related to expected capacity to manage risk, and positively related to an organization's past propensity to take risks. Further, perceived risk, anticipated resource availability, and exposure to field-based evidence explained a substantial part of what differentiated adopters from nonadopters. Finally, several features of innovations known to influence innovation adoption decisions were found to be related in expected ways to perceived risk, capacity to manage risk, and risk propensity. This research supports the view that the decision to adopt an innovative mental health practice is a decision made in consideration of risk. Contrary to popular views that early adopters of innovations are willing to take enormous risks, these data offer the novel idea that early adopters act because they see the risks associated with adopting as lower than their nonadopter counterparts, partly because the risks are seen as more manageable. Implications of results are discussed for organizations considering adoption of innovative health care practices and for state or local mental health authorities hoping for a higher level of adoption in their areas.