Assessment studies: Difference between revisions
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==State of the art in benefit–risk analysis: Economics and Marketing-Finance== | ==State of the art in benefit–risk analysis: Economics and Marketing-Finance== | ||
N. Kalogeras, G. Odekerken-Schröder, J.M.E. Pennings, H. Gunnlaugsdottir, F. Holm, O. Leino, J.M. Luteijn, S.H. Magnússon, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, Ø. Ueland, B.C. White, H. Verhagen: State of the art in benefit–risk analysis: Economics and Marketing-Finance. Food and Chemical Toxicology 50 (2012) 56–66 {{doi|10.1016/j.fct.2011.07.066}} | |||
N. Kalogeras, G. Odekerken-Schröder, J.M.E. Pennings, H. Gunnlaugsdottir, F. Holm, O. Leino, J.M. Luteijn, S.H. Magnússon, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, Ø. Ueland, B.C. White, H. Verhagen {{doi|10.1016/j.fct.2011.07.066}} | |||
===Abstract=== | ===Abstract=== | ||
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for measuring benefit–risk trade-offs in the economics and marketing-finance literature, and different fac- | for measuring benefit–risk trade-offs in the economics and marketing-finance literature, and different fac- | ||
tors that may affect the economic behaviour in the light of benefit–risk analyses. | tors that may affect the economic behaviour in the light of benefit–risk analyses. | ||
Building on the findings of our review, we introduce a conceptual framework to study the benefit–risk | Building on the findings of our review, we introduce a conceptual framework to study the benefit–risk | ||
behaviour of market participants. Specifically, we suggest the decoupling of benefits and risks into the sep- | behaviour of market participants. Specifically, we suggest the decoupling of benefits and risks into the sep- | ||
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the drivers of the economic behaviour of market participants with respect to production, marketing and | the drivers of the economic behaviour of market participants with respect to production, marketing and | ||
consumption of food products. | consumption of food products. | ||
<br/> | <br/> | ||
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Benefit–risk trade-offs, Decoupling, Utility, Economics, Marketing-Finance | Benefit–risk trade-offs, Decoupling, Utility, Economics, Marketing-Finance | ||
==State of the art in benefit–risk analysis: Medicines== | |||
J.M. Luteijn, B.C. White, H. Gunnlaugsdóttir, F. Holm, N. Kalogeras, O. Leino, S.H. Magnússon, | |||
G. Odekerken, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, Ø. Ueland, P.A. McCarron, H. Verhagen: State of the art in benefit–risk analysis: Medicines. Food and Chemical Toxicology 50 (2012) 26–32 {{doi|10.1016/j.fct.2011.06.008}} | |||
===Abstract=== | |||
Benefit–risk assessment in medicine has been a valuable tool in the regulation of medicines since the | |||
1960s. Benefit–risk assessment takes place in multiple stages during a medicine’s life-cycle and can be | |||
conducted in a variety of ways, using methods ranging from qualitative to quantitative. Each benefit–risk | |||
assessment method is subject to its own specific strengths and limitations. Despite its widespread and | |||
long-time use, benefit–risk assessment in medicine is subject to debate and suffers from a number of lim- | |||
itations and is currently still under development. | |||
This state of the art review paper will discuss the various aspects and approaches to benefit–risk | |||
assessment in medicine in a chronological pathway. The review will discuss all types of benefit–risk | |||
assessment a medicinal product will undergo during its lifecycle, from Phase I clinical trials to post-mar- | |||
keting surveillance and health technology assessment for inclusion in public formularies. The benefit– | |||
risk profile of a drug is dynamic and differs for different indications and patient groups. In the end of this | |||
review we conclude benefit–risk analysis in medicine is a developed practice that is subject to continuous | |||
improvement and modernisation. Improvement not only in methodology, but also in cooperation | |||
between organizations can improve benefit–risk assessment. | |||
<br/> | |||
{{Publication | |||
| authors = J.M. Luteijn, B.C. White, H. Gunnlaugsdóttir, F. Holm, N. Kalogeras, O. Leino, S.H. Magnússon, G. Odekerken, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, Ø. Ueland, P.A. McCarron, H. Verhagen | |||
| page = State of the art in benefit–risk analysis: Medicines | |||
| publishingyear = 2011 | |||
| elsewhere = Food and Chemical Toxicology 50 (2012) 26–32}} | |||
===Key words=== | |||
Benefit–risk assessment, Health technology assessment, Pharmacovigilance, Drug approval/methods, Risk assessment | |||
==State of the art in benefit–risk analysis: Food microbiology== | |||
S.H. Magnússon, H. Gunnlaugsdóttir, H. van Loveren, F. Holm, N. Kalogeras, O. Leino, J.M. Luteijn, | |||
G. Odekerken, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, Ø. Ueland, B.C. White, H. Verhagen: State of the art in benefit–risk analysis: Food microbiology. Food and Chemical Toxicology 50 (2012) 33–39 {{doi|10.1016/j.fct.2011.06.005}} | |||
===Abstract=== | |||
Over the past years benefit–risk analysis (BRA) in relation to foods and food ingredients has gained much | |||
attention; in Europe and worldwide. BRA relating to food microbiology is however a relatively new field | |||
of research. Microbiological risk assessment is well defined but assessment of microbial benefits and the | |||
weighing of benefits and risk has not been systematically addressed. In this paper the state of the art in | |||
benefit–risk analysis in food microbiology is presented, with a brief overview of microbiological food | |||
safety practices. | |||
The quality and safety of foods is commonly best preserved by delaying the growth of spoilage bacteria | |||
and contamination by bacterial pathogens. However, microorganisms in food can be both harmful and | |||
beneficial. Many microorganisms are integral to various food production processes e.g. the production | |||
of beer, wine and various dairy products. Moreover, the use of some microorganisms in the production | |||
of fermented foods are often claimed to have beneficial effects on food nutrition and consumer health. | |||
Furthermore, food safety interventions leading to reduced public exposure to foodborne pathogens can | |||
be regarded as benefits. The BRA approach integrates an independent assessment of both risks and ben- | |||
efits and weighs the two using a common currency. | |||
Recently, a number of initiatives have been launched in the field of food and nutrition to address the | |||
formulation of the benefit–risk assessment approach. BRA has recently been advocated by EFSA for the | |||
public health management of food and food ingredients; as beneficial and adverse chemicals can often | |||
be found within the same foods and even the same ingredients. These recent developments in the scoping | |||
of BRA could be very relevant for food microbiological issues. BRA could become a valuable methodology | |||
to support evaluations and decision making regarding microbiological food safety and public health, sup- | |||
plementing other presently available policy making and administrative tools for microbiological food | |||
safety management. | |||
<br/> | |||
{{Publication | |||
| authors = S.H. Magnússon, H. Gunnlaugsdóttir, H. van Loveren, F. Holm, N. Kalogeras, O. Leino, J.M. Luteijn, | |||
G. Odekerken, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, Ø. Ueland, B.C. White, H. Verhagen | |||
| page = State of the art in benefit–risk analysis: Food microbiology | |||
| publishingyear = 2012 | |||
| elsewhere = Food and Chemical Toxicology 50 (2012) 33–39}} | |||
===Keywords=== | |||
Risk assessment, Microbiological risk assessment, Benefit–risk assessment, Food microbiology | |||
==Openness in participation, assessment, and policy making upon issues of environment and environmental health: a review of literature and recent project results== | |||
Mikko V. Pohjola and Jouni T. Tuomisto: Openness in participation, assessment, and policy making upon issues of environment and environmental health: a review of literature and recent project results. Environmental Health 2011, 10:58 http://www.ehjournal.net/content/10/1/58. | |||
===Abstract=== | |||
Issues of environment and environmental health involve multiple interests regarding e.g. political, societal, economical, and public concerns represented by different kinds of organizations and individuals. Not surprisingly, stakeholder and public participation has become a major issue in environmental and environmental health policy and assessment. The need for participation has been discussed and reasoned by many, including environmental legislators around the world. In principle, participation is generally considered as desirable and the focus of most scholars and practitioners is on carrying out participation, and making participation more effective. In practice also doubts regarding the effectiveness and importance of participation exist among policy makers, assessors, and public, leading even to undermining participatory practices in policy making and assessment. | |||
There are many possible purposes for participation, and different possible models of interaction between assessment and policy. A solid conceptual understanding of the interrelations between participation, assessment, and policy making is necessary in order to design and implement effective participatory practices. In this paper we ask, do current common conceptions of assessment, policy making and participation provide a sufficient framework for achieving effective participation? This question is addresses by reviewing the range of approaches to participation in assessment and policy making upon issues of environment and environmental health and some related insights from recent research projects, INTARESE and BENERIS. | |||
Openness, considered e.g. in terms of a) scope of participation, b) access to information, c) scope of contribution, d) timing of openness, and e) impact of contribution, provides a new perspective to the relationships between participation, assessment and policy making. Participation, assessment, and policy making form an inherently intertwined complex with interrelated objectives and outcomes. Based on experiences from implementing openness, we suggest complete openness as the new default, deviation from which should be explicitly argued, in assessment and policy making upon issues of environment and environmental health. Openness does not undermine the existing participatory models and techniques, but provides conceptual means for their more effective application, and opens up avenues for developing new kinds of effective participatory practices that aim for societal development through collaborative creation of knowledge. | |||
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{{Publication | |||
| authors = Mikko V. Pohjola, Jouni T. Tuomisto | |||
| page = Openness in participation, assessment, and policy making upon issues of environment and environmental health: a review of literature and recent project results | |||
| publishingyear = 2011 | |||
| elsewhere = Environmental Health 2011, 10:58 http://www.ehjournal.net/content/10/1/58}} | |||
===Keywords=== | |||
==State of the art in benefit–risk analysis: Environmental health== | |||
M.V. Pohjola, O. Leino, V. Kollanus, J.T. Tuomisto, H. Gunnlaugsdóttir, F. Holm, N. Kalogeras, J.M. Luteijn, S.H. Magnússon, G. Odekerken, M.J. Tijhuis, Ø. Ueland, B.C. White, H. Verhagen: State of the art in benefit–risk analysis: Environmental health. Food and Chemical Toxicology 50 (2012) 40–55, {{doi|10.1016/j.fct.2011.06.004}} | |||
===Abstract=== | |||
Environmental health assessment covers a broad area: virtually all systematic analysis to support decision making on issues relevant to environment and health. Consequently, various different approaches have been developed and applied for different needs within the broad field. In this paper we explore the plurality of approaches and attempt to reveal the state-of-the-art in environmental health assessment by characterizing and explicating the similarities and differences between them. A diverse, yet concise, set of approaches to environmental health assessment is analyzed in terms of nine attributes: purpose, problem owner, question, answer, process, use, interaction, performance and establishment. The conclusions of the analysis underline the multitude and complexity of issues in environmental health assessment as well as the variety of perspectives taken to address them. In response to the challenges, a tendency towards developing and applying more inclusive, pragmatic and integrative approaches can be identified. The most interesting aspects of environmental health assessment are found among these emerging approaches: (a) increasing engagement between assessment and management as well as stakeholders, (b) strive for framing assessments according to specific practical policy needs, (c) integration of multiple benefits and risks, as well as (d) explicit incorporation of both scientific facts and value statements in assessment. However, such approaches are yet to become established, and many contemporarymainstream environmental health assessment practices can still be characterized as relatively traditional risk assessment. | |||
<br/> | |||
{{Publication | |||
| authors = M.V. Pohjola, O. Leino, V. Kollanus, J.T. Tuomisto, H. Gunnlaugsdóttir, F. Holm, N. Kalogeras, J.M. Luteijn, S.H. Magnússon, G. Odekerken, M.J. Tijhuis, Ø. Ueland, B.C. White, H. Verhagen | |||
| page = State of the art in benefit–risk analysis: Environmental health | |||
| publishingyear = 2012 | |||
| elsewhere = Food and Chemical Toxicology 50 (2012) 40–55}} | |||
===Keywords=== | |||
Environmental healt, Benefit-risk assessment, Impact assessment, Integrated assessment | |||
==The health risks and benefits of cycling in urban environments compared with car use: health impact assessment study== | |||
David Rojas-Rueda, Audrey de Nazelle, Marko Tainio, Mark J Nieuwenhuijsen: The health risks and benefits of cycling in urban environments compared with car use: health impact assessment study. BMJ 2011;343:d4521 {{doi|10.1136/bmj.d4521}}. | |||
===Abstract=== | |||
''Objective'': To estimate the risks and benefits to health of travel by bicycle, using a bicycle sharing scheme, compared with travel by car in an urban environment. | |||
''Design'': Health impact assessment study. | |||
''Setting'': Public bicycle sharing initiative, Bicing, in Barcelona, Spain. | |||
''Participants'': 181 982 Bicing subscribers. | |||
''Main outcomes'': measures The primary outcome measure was all cause mortality for the three domains of physical activity, air pollution (exposure to particulate matter <2.5 μm), and road traffic incidents. The secondary outcome was change in levels of carbon dioxide emissions. Results Compared with car users the estimated annual change in mortality of the Barcelona residents using Bicing (n=181 982) was 0.03 deaths from road traffic incidents and 0.13 deaths from air pollution. As a result of physical activity, 12.46 deaths were avoided (benefit:risk ratio 77). The annual number of deaths avoided was 12.28. As a result of journeys by Bicing, annual carbon dioxide emissions were reduced by an estimated 9 062 344 kg. | |||
''Conclusions'': Public bicycle sharing initiatives such as Bicing in Barcelona have greater benefits than risks to health and reduce carbon dioxide emissions. | |||
<br/> | |||
{{Publication | |||
| authors = David Rojas-Rueda, Audrey de Nazelle, Marko Tainio, Mark J Nieuwenhuijsen | |||
| page = The health risks and benefits of cycling in urban environments compared with car use: health impact assessment study | |||
| publishing = 2011 | |||
| elsewhere = BMJ 2011;343:d4521}} | |||
===Keywords=== | |||
Air pollution, Environmental issues, Epidemiologic studies, Epidemiology, Public health | |||
==Evaluation of intake fractions for different subpopulations due to primary fine particulate matter (PM<sub>2.5</sub>) emitted from domestic wood combustion and traffic in Finland== | |||
Pauliina Taimisto, Marko Tainio, Niko Karvosenoja, Kaarle Kupiainen, Petri Porvari, Ari Karppinen, Leena Kangas, Jaakko Kukkonen, Jouni T. Tuomisto: Evaluation of intake fractions for different subpopulations due to primary fine particulate matter (PM2.5) emitted from domestic wood combustion and traffic in Finland. Air quality, atmosphere & health. Received: 29 October 2009 / Accepted: 8 February 2011 (c) Springer Science+Business Media B.V. 2011 {{doi|10.1007/s11869-011-0138-3}}. | |||
===Abstract=== | |||
Domestic wood combustion and traffic are the two most significant primary fine particulate matter (PM<sub>2.5</sub>) emission source categories in Finland. We estimated emission–exposure relationships for primary PM<sub>2.5</sub> emissions from these source categories using intake fractions (iF), which describes the fraction of an emission that is ultimately inhaled by a target population. The iFs were calculated for four different emission source subcategories | |||
in Finland in 2000: (1) domestic wood combustion in residential buildings, (2) domestic wood combustion in recreational buildings, (3) traffic exhaust and wear emissions, and (4) traffic resuspension emissions. The iFs were estimated for both total population and for subpopulations | |||
with different gender, age, and educational status. Primary PM<sub>2.5</sub> emissions were based on the Finnish Regional Emission Scenario model and the dispersion of particles was calculated using the Urban Dispersion Modeling system of Finnish Meteorological Institute. Both emissions and dispersion were estimated on a 1 km spatial resolution. | |||
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{{Publication | |||
| authors = Pauliina Taimisto, Marko Tainio, Niko Karvosenoja, Kaarle Kupiainen, Petri Porvari, Ari Karppinen, Leena Kangas, Jaakko Kukkonen, Jouni T. Tuomisto | |||
| page = Evaluation of intake fractions for different subpopulations due to primary fine particulate matter (PM2.5) emitted from domestic wood combustion and traffic in Finland | |||
| elsewhere = Air quality, atmosphere & health. Received: 29 October 2009 / Accepted: 8 February 2011 (c) Springer Science+Business Media B.V. 2011}} | |||
===Keywords=== | |||
iF, Intake fraction, Exposure, Particulate matter, Domestic combustion, Traffic | |||
==Uncertainty in health risks due to anthropogenic primary fine particulate matter from different source types in Finland== | |||
M. Tainio, J.T. Tuomisto, J. Pekkanen, N. Karvosenoja, K. Kupiainen, P. Porvari, M. Sofiev, A. Karppinen, L. Kangas, J. Kukkonen: Uncertainty in health risks due to anthropogenic primary fine particulate matter from different source types in Finland. Atmospheric Environment 44 (2010) 2125e2132 {{doi|10.1016/j.atmosenv.2010.02.036}} | |||
===Abstract=== | |||
The emission-exposure and exposure-response (toxicity) relationships are different for different emission source categories of anthropogenic primary fine particulate matter (PM<sub>2.5</sub>2.5). These variations have a potentially crucial importance in the integrated assessment, when determining cost-effective abatement strategies. We studied the importance of these variations by conducting a sensitivity analysis for an integrated assessment model. The model was developed to estimate the adverse health effects to the Finnish population attributable to primary PM<sub>2.5</sub> emissions from the whole of Europe. The primary PM<sub>2.5</sub> emissions in the whole of Europe and in more detail in Finland were evaluated using the inventory of the European Monitoring and Evaluation Programme (EMEP) and the Finnish Regional Emission Scenario model (FRES), respectively. The emission-exposure relationships for different primary PM<sub>2.5</sub> emission source categories in Finland have been previously evaluated and these values incorporated as intake fractions into the integrated assessment model. The primary PM<sub>2.5</sub> exposure-response functions and toxicity differences for the pollution originating from different source categories were estimated in an expert elicitation study performed by six European experts on air pollution health effects. The primary PM<sub>2.5</sub> emissions from Finnish and other European sources were estimated for the population of Finland in 2000 to be responsible for 209 (mean, 95% confidence interval 6e739) and 357 (mean, 95% CI 8e1482) premature deaths, respectively. The inclusion of emission-exposure and toxicity variation into the model increased the predicted relative importance of traffic related primary PM<sub>2.5</sub> emissions and correspondingly, decreased the predicted relative importance of other emission source categories. We conclude that the variations of emission-exposure relationship and toxicity between various source categories had significant impacts for the assessment on premature deaths caused by primary PM<sub>2.5</sub>. | |||
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{{Publication | |||
| authors = M. Tainio, J.T. Tuomisto, J. Pekkanen, N. Karvosenoja, K. Kupiainen, P. Porvari, M. Sofiev, A. Karppinen, L. Kangas, J. Kukkonen | |||
| page = Uncertainty in health risks due to anthropogenic primary fine particulate matter from different source types in Finland | |||
| publishingyear = 2010 | |||
| elsewhere = Atmospheric Environment 44 (2010) 2125e2132}} | |||
===Keywords=== | |||
Fine particulate matter, Intake fraction, Exposure-response, Integrated assessment, Sensitivity analysis | |||
==Impact of airborne particulate matter on human health: an assessment framework to estimate exposure and adverse health effects in Poland== | |||
Marko Tainio, Jaakko Kukkonen, Zbigniew Nahorski: Impact of airborne particulate matter on human health: an assessment framework to estimate exposure and adverse health effects in Poland. Arcghives of environmentl protection vol. 36 no. 1 pp. 95-115, 2010 | |||
===Abstract=== | |||
Fine particulate matter (PM<sub>2.5</sub>) air pollution is one of the main environmental health problems in developed countries. According to modeling estimates the PM<sub>2.5</sub> concentrations in Poland are among the highest in Europe. In this article we focus on exposure assessment and estimation of adverse health effects due to PM<sub>2.5</sub> air pollution. This article consists of two parts. In the first part, we discuss the main methods used to estimate emission-exposure relationships and adverse health effects due to PM<sub>2.5</sub> air pollution. In the second part, we present an assessment framework for Poland. We illustrate this framework by estimating the premature deaths and change in life expectancy in Poland caused by anthropogenic, primary PM<sub>2.5</sub> emissions from different European countries, and, in propotion, the premature deaths in different European countries caused by primary PM<sub>2.5</sub> emissions from Poland. The PM<sub>2.5</sub> emissions were evaluated using the inventory of the European Monitoring and Evaluation Programme (EMEP). The emission-exposure relationships were based on previously published study and the exposure-response functions for PM<sub>2.5</sub> air pollution were estimated in expert elicitation study performed for six European experts on air pollution health effects. Based on the assessment, the anthropogenic primary PM<sub>2.5</sub> from the whole Europe is estimated to cause several thousand of premature deaths in Poland, annually. There premature deaths are both due to PM<sub>2.5</sub> emissions from Poland and transportation of PM<sub>2.5</sub> from other European countries, both of these in almost equal parts. The framework is presented in this article will be developed in the near future to a full scale integrated assessment, that takes into account both gaseous and PM<sub>2.5</sub> air pollution. | |||
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{{Publication | |||
| authors =Marko Tainio, Jaakko Kukkonen, Zbigniew Nahorski | |||
| page = Impact of airborne particulate matter on human health: an assessment framework to estimate exposure and adverse health effects in Poland | |||
| publishingyear = 2010 | |||
| elsewhere = Arcghives of environmentl protection vol. 36 no. 1 pp. 95-115, 2010}} | |||
===Keywords=== | |||
Fine particulate matter, PM<sub>2.5</sub>, exposure, intake fraction, integrated assessment, Poland | |||
==State of the art in benefit–risk analysis: Food and nutrition== | |||
M.J. Tijhuis, N. de Jong, M.V. Pohjola, H. Gunnlaugsdóttir, M. Hendriksen, J. Hoekstra, F. Holm, N. Kalogeras, O. Leino, F.X.R. van Leeuwen, J.M. Luteijn, S.H. Magnússon, G. Odekerken, C. Rompelberg, J.T. Tuomisto, Ø. Ueland, B.C. White, H. Verhagen: State of the art in benefit–risk analysis: Food and nutrition. Food and Chemical Toxicology 50 (2012) 5–25 | |||
{{doi|10.1016/j.fct.2011.06.010}} | |||
===Abstract=== | |||
Benefit–risk assessment in food and nutrition is relatively new. It weighs the beneficial and adverse effects that a food (component) may have, in order to facilitate more informed management decisions regarding public health issues. It is rooted in the recognition that good food and nutrition can improve health and that some risk may be acceptable if benefit is expected to outweigh it. This paper presents an overview of current concepts and practices in benefit–risk analysis for food and nutrition. It aims to facilitate scientists and policy makers in performing, interpreting and evaluating benefit–risk assessments. | |||
Historically, the assessments of risks and benefits have been separate processes. Risk assessment is mainly addressed by toxicology, as demanded by regulation. It traditionally assumes that a maximum safe dose can be determined from experimental studies (usually in animals) and that applying appropriate uncertainty factors then defines the ‘safe’ intake for human populations. There is a minor role for other research traditions in risk assessment, such as epidemiology, which quantifies associations between determinants and health effects in humans. These effects can be both adverse and beneficial. Benefit assessment is newly developing in regulatory terms, but has been the subject of research for a long time within nutrition and epidemiology. The exact scope is yet to be defined. Reductions in risk can be termed benefits, but also states rising above ‘the average health’ are explored as benefits. In nutrition, current interest is in ‘optimal’ intake; from a population perspective, but also from a more individualised perspective. | |||
In current approaches to combine benefit and risk assessment, benefit assessment mirrors the traditional risk assessment paradigm of hazard identification, hazard characterization, exposure assessment and risk characterization. Benefit–risk comparison can be qualitative and quantitative. In a quantitative comparison, benefits and risks are expressed in a common currency, for which the input may be deterministic or (increasingly more) probabilistic. A tiered approach is advocated, as this allows for transparency, an early stop in the analysis and interim interaction with the decision-maker. A general problem in the disciplines underlying benefit–risk assessment is that good dose–response data, i.e. at relevant intake | |||
levels and suitable for the target population, are scarce. | |||
It is concluded that, provided it is clearly explained, benefit–risk assessment is a valuable approach to systematically show current knowledge and its gaps and to transparently provide the best possible science-based answer to complicated questions with a large potential impact on public health. | |||
<br/> | |||
{{Publication | |||
| authors = M.J. Tijhuis, N. de Jong, M.V. Pohjola, H. Gunnlaugsdóttir, M. Hendriksen, J. Hoekstra, F. Holm, N. Kalogeras, O. Leino, F.X.R. van Leeuwen, J.M. Luteijn, S.H. Magnússon, G. Odekerken, C. Rompelberg, J.T. Tuomisto, Ø. Ueland, B.C. White, H. Verhagen | |||
| page = State of the art in benefit–risk analysis: Food and nutrition | |||
| publishingyear = 2012 | |||
| elsewhere = Food and Chemical Toxicology 50 (2012) 5–25}} | |||
===Keywords=== | |||
Benefit–risk, Benefit, Risk, Food, Nutrition | |||
==Looking beyond borders: Integrating best practices in benefit–risk analysis into the field of Food and Nutrition== | |||
M.J. Tijhuis, M.V. Pohjola, H. Gunnlaugsdóttir, N. Kalogeras, O. Leino, J.M. Luteijn, S.H. Magnússon, G. Odekerken-Schröder, M. Poto, J.T. Tuomisto, Ø. Ueland, B.C. White, F. Holm, H. Verhagen: Looking beyond borders: Integrating best practices in benefit–risk analysis into the field of Food and Nutrition. Food and Chemical Toxicology 50 (2012) 77–93 | |||
{{doi|10.1016/j.fct.2011.11.044}} | |||
===Abstract=== | |||
An integrated benefit–risk analysis aims to give guidance in decision situations where benefits do not clearly prevail over risks, and explicit weighing of benefits and risks is thus indicated. The BEPRARIBEAN project aims to advance benefit–risk analysis in the area of food and nutrition by learning from other fields. This paper constitutes the final stage of the project, in which commonalities and differences in benefit–risk analysis are identified between the Food and Nutrition field and other fields, namely Medicines, Food Microbiology, Environmental Health, Economics and Marketing–Finance, and Consumer Perception. From this, ways forward are characterized for benefit–risk analysis in Food and Nutrition. Integrated benefit–risk analysis in Food and Nutrition may advance in the following ways: Increased engagement and communication between assessors, managers, and stakeholders; more pragmatic problem-oriented framing of assessment; accepting some risk; pre- and post-market analysis; explicit communication of the assessment purpose, input and output; more human (dose–response) data and more efficient use of human data; segmenting populations based on physiology; explicit consideration of value judgments in assessment; integration of multiple benefits and risks from multiple domains; explicit recognition of the impact of consumer beliefs, opinions, views, perceptions, and attitudes on behaviour; and segmenting populations based on behaviour; the opportunities proposed here do not provide ultimate solutions; rather, they define a collection of issues to be taken account of in developing methods, tools, practices and policies, as well as refining the regulatory context, for benefit–risk analysis in Food and Nutrition and other fields. Thus, these opportunities will now need to be explored further and incorporated into benefit–risk practice and policy. If accepted, incorporation of these opportunities will also involve a paradigm shift in Food and Nutrition benefit–risk analysis towards conceiving the analysis as a process of creating shared knowledge among all stakeholders. | |||
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{{Publication | |||
| authors = M.J. Tijhuis, M.V. Pohjola, H. Gunnlaugsdóttir, N. Kalogeras, O. Leino, J.M. Luteijn, S.H. Magnússon, G. Odekerken-Schröder, M. Poto, J.T. Tuomisto, Ø. Ueland, B.C. White, F. Holm, H. Verhagen | |||
| page = Looking beyond borders: Integrating best practices in benefit–risk analysis into the field of Food and Nutrition | |||
| publishingyear = 2012 | |||
| elsewhere = Food and Chemical Toxicology 50 (2012) 77–93}} | |||
===Keywords=== | |||
Benefit–risk, Food & nutrition, Best practice, Assessment, Management, Shared understanding | |||
==State of the art in benefit–risk analysis: Consumer perception== | |||
Ø. Ueland, H. Gunnlaugsdottir, F. Holm, N. Kalogeras, O. Leino, J.M. Luteijn, S.H. Magnússon, G. Odekerken, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, B.C. White, H. Verhagen: State of the art in benefit–risk analysis: Consumer perception. Food and Chemical Toxicology 50 (2012) 67–76 {{doi|10.1016/j.fct.2011.06.006}} | |||
===Abstract=== | |||
Benefit and risk perception with respect to food consumption, have been a part of human daily life from beginning of time. In today’s society the food chain is long with many different types of actors and low degree of transparency. Making informed food choices where knowledge of benefits and risks is part of the decision making process are therefore complicated for consumers. Thus, to understand how consumers perceive benefits and risks of foods, their importance in relation to quality evaluations are aspects that need to be addressed. The objective of this paper is to discuss state of the art in understanding consumer perceptions of benefits and risks of foods in order to improve understanding of consumer behaviour in the food domain. | |||
Risks may be associated with both acute and long term consequences, some of which may have serious effects. Perceived risks are connected to morbidity and mortality along two dimensions relating to unknown risk, and to which extent the risk is dreaded by the consumer. Unfamiliar, uncertain, unknown, uncontrollable, and severe consequences are some factors associated with risk perception. Novel food processing techniques, for instance, score high on several of these parameters and are consequently regarded with suspicion and perceived as risky by consumers. | |||
On a daily basis, benefits of foods and food consumption are more important in most consumers’ minds than risks. Benefits are often associated with food’s ability to assuage hunger, and to provide pleasure through eating and socialising. In addition, two main categories of benefits that are important for acceptance of product innovations are health and environmental benefits. | |||
Benefit and risk perception of foods seem to be inversely correlated, so when something is perceived as being highly beneficial, it is correspondingly perceived as having low risk. However, slightly different paths are used in the formation of these perceptions; benefit perception is based on heuristics and experience, while risk perception is to a larger extent the result of cognitive information processing. Consumers are particularly conservative when it comes to perception and acceptance of foods compared to other products. Benefit-risk evaluations tend to be skewed towards acceptance of all that is traditional and well-known (benefits), and rejection or suspicion towards anything that is novel or highly processed (risks) regardless of actual risk. Knowledge of how consumers perceive benefits and risks of foods, may contribute to understanding benefit-risk perception in other areas related to personal, societal or environmental perspectives. | |||
<br/> | |||
{{Publication | |||
| authors = Ø. Ueland, H. Gunnlaugsdottir, F. Holm, N. Kalogeras, O. Leino, J.M. Luteijn, S.H. Magnússon, G. Odekerken, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, B.C. White, H. Verhagen | |||
| page = State of the art in benefit–risk analysis: Consumer perception | |||
| publishingyear = 2012 | |||
| elsewhere = Food and Chemical Toxicology 50 (2012) 67–76}} | |||
===Keywords=== | |||
Consumer behaviour, Risk perception, Benefit perception | |||
==State of the art in benefit–risk analysis: Introduction== | |||
H. Verhagen, M.J. Tijhuis, H. Gunnlaugsdottir, N. Kalogeras, O. Leino, J.M. Luteijn, S.H. Magnússon, G. Odekerken, M.V. Pohjola, J.T. Tuomisto, Ø. Ueland, B.C. White, F. Holm: State of the art in benefit–risk analysis: Introduction. Food and Chemical Toxicology 50 (2012) 2–4 {{doi|10.1016/j.fct.2011.06.007}} | |||
===Abstract=== | |||
Risk-taking is normal in everyday life if there are associated (perceived) benefits. Benefit-Risk Analysis (BRA) compares the risk of a situation to its related benefits and addresses the acceptability of the risk. Over the past years BRA in relation to food and food ingredients has gained attention. Food, and even the same food ingredient, may confer both beneficial and adverse effects. Measures directed at food safety may lead to suboptimal or insufficient levels of ingredients from a benefit perspective. In BRA, benefits and risks of food (ingredients) are assessed in one go and may conditionally be expressed into one currency. This allows the comparison of adverse and beneficial effects to be qualitative and quantitative. A BRA should help policy-makers to make more informed and balanced benefit-risk management decisions. Not allowing food benefits to occur in order to guarantee food safety is a risk management decision much the same as accepting some risk in order to achieve more benefits. BRA in food and nutrition is making progress, but difficulties remain. The field may benefit from looking across its borders to learn from other research areas. The BEPRARIBEAN project (Best Practices for Risk-Benefit Analysis: experience from out of food into food; [http://en.opasnet.org/w/Bepraribean]) aims to do so, by working together with Medicines, Food Microbiology, Environmental Health, Economics & Marketing-Finance and Consumer Perception. All perspectives are reviewed and subsequently integrated to identify opportunities for further development of BRA for food and food ingredients. Interesting issues that emerge are the varying degrees of risk that are deemed acceptable within the areas and the trend towards more open and participatory BRA processes. A set of 6 ‘state of the art’ papers covering the above areas and a paper integrating the separate (re)views are published in this volume. | |||
<br/> | |||
{{Publication | |||
| authors = H. Verhagen, M.J. Tijhuis, H. Gunnlaugsdottir, N. Kalogeras, O. Leino, J.M. Luteijn, S.H. Magnússon, G. Odekerken, M.V. Pohjola, J.T. Tuomisto, Ø. Ueland, B.C. White, F. Holm | |||
| page = State of the art in benefit–risk analysis: Introduction | |||
| publishingyear = 2012 | |||
| elsewhere = Food and Chemical Toxicology 50 (2012) 2–4}} | |||
===Keywords=== | |||
Benefit-risk, Best practice, BEPRARIBEAN |
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Pragmatic knowledge services
Mikko V. Pohjola, Pasi Pohjola, Sami Paavola, Merja Bauters, Jouni T. Tuomisto: Pragmatic knowledge services. Journal of Universal Computer Science, vol. 17, no. 3 (2011), 472-497 submitted: 30/10/10, accepted: 28/1/11, appeared: 1/2/11 © J.UCS
Abstract
Knowledge, innovations and their implementation in effective practices are essential for development in all fields of societal action, e.g. policy, business, health, education, and everyday life. However, managing the interrelations between knowledge, innovation and practice is complicated. Facilitation by suitable knowledge services is needed. This paper explores the theory of converging knowledge, innovation, and practice, discusses some advances in information systems development, and identifies general requirements for pragmatic knowledge services. A trialogical approach to knowledge creation and learning is adopted as a viable theoretical basis. Also three examples of novel knowledge services Opasnet, Innovillage, and Knowledge Practices Environment (KPE), are presented. Eventually, it is concluded that pragmatic knowledge services, as hybrid systems of information technology and its users, are not only means for creation of practical knowledge, but vehicles of a cultural change from individualistic perceptions of knowledge work towards mediated collaboration.
Mikko V. Pohjola, Pasi Pohjola, Sami Paavola, Merja Bauters, Jouni T. Tuomisto: Pragmatic knowledge services. Opasnet 2011. [1]. Accessed 22 Aug 2024. This page has also been published elsewhere: Journal of Universal Computer Science, vol. 17, no. 3 (2011), 472-497.
Keywords
Collective knowledge, Trialogical approach, Innovation, Knowledge practices, Pragmatism, Collaborative knowledge services, Open assessment, Opasnet, Innovillage, KP-Lab, KPE
State of the art in benefit–risk analysis: Economics and Marketing-Finance
N. Kalogeras, G. Odekerken-Schröder, J.M.E. Pennings, H. Gunnlaugsdottir, F. Holm, O. Leino, J.M. Luteijn, S.H. Magnússon, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, Ø. Ueland, B.C. White, H. Verhagen: State of the art in benefit–risk analysis: Economics and Marketing-Finance. Food and Chemical Toxicology 50 (2012) 56–66 doi:10.1016/j.fct.2011.07.066
Abstract
All market participants (e.g., investors, producers, consumers) accept a certain level of risk as necessary to achieve certain benefits. There are many types of risk including price, production, financial, institutional, and individual human risks. All these risks should be effectively managed in order to derive the utmost of benefits and avoid disruption and/or catastrophic economic consequences for the food industry. The iden- tification, analysis, determination, and understanding of the benefit–risk trade-offs of market participants in the food markets may help policy makers, financial analysts and marketers to make well-informed and effective corporate investment strategies in order to deal with highly uncertain and risky situations. In this paper, we discuss the role that benefits and risks play in the formation of the decision-making pro- cess of market-participants, who are engaged in the upstream and downstream stages of the food supply chain. In addition, we review the most common approaches (expected utility model and psychometrics) for measuring benefit–risk trade-offs in the economics and marketing-finance literature, and different fac- tors that may affect the economic behaviour in the light of benefit–risk analyses.
Building on the findings of our review, we introduce a conceptual framework to study the benefit–risk behaviour of market participants. Specifically, we suggest the decoupling of benefits and risks into the sep- arate components of utilitarian benefits, hedonic benefits, and risk attitude and risk perception, respec- tively. Predicting and explaining how market participants in the food industry form their overall attitude in light of benefit–risk trade-offs may be critical for policy-makers and managers who need to understand the drivers of the economic behaviour of market participants with respect to production, marketing and consumption of food products.
N. Kalogeras, G. Odekerken-Schröder, J.M.E. Pennings, H. Gunnlaugsdottir, F. Holm, O. Leino, J.M. Luteijn, S.H. Magnússon, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, Ø. Ueland, B.C. White, H. Verhagen: State of the art in benefit–risk analysis: Economics and Marketing-Finance. Opasnet 2012. [2]. Accessed 22 Aug 2024. This page has also been published elsewhere: Food and Chemical Toxicology 50 (2012) 56–66.
Keywords
Benefit–risk trade-offs, Decoupling, Utility, Economics, Marketing-Finance
State of the art in benefit–risk analysis: Medicines
J.M. Luteijn, B.C. White, H. Gunnlaugsdóttir, F. Holm, N. Kalogeras, O. Leino, S.H. Magnússon, G. Odekerken, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, Ø. Ueland, P.A. McCarron, H. Verhagen: State of the art in benefit–risk analysis: Medicines. Food and Chemical Toxicology 50 (2012) 26–32 doi:10.1016/j.fct.2011.06.008
Abstract
Benefit–risk assessment in medicine has been a valuable tool in the regulation of medicines since the 1960s. Benefit–risk assessment takes place in multiple stages during a medicine’s life-cycle and can be conducted in a variety of ways, using methods ranging from qualitative to quantitative. Each benefit–risk assessment method is subject to its own specific strengths and limitations. Despite its widespread and long-time use, benefit–risk assessment in medicine is subject to debate and suffers from a number of lim- itations and is currently still under development.
This state of the art review paper will discuss the various aspects and approaches to benefit–risk assessment in medicine in a chronological pathway. The review will discuss all types of benefit–risk assessment a medicinal product will undergo during its lifecycle, from Phase I clinical trials to post-mar- keting surveillance and health technology assessment for inclusion in public formularies. The benefit– risk profile of a drug is dynamic and differs for different indications and patient groups. In the end of this review we conclude benefit–risk analysis in medicine is a developed practice that is subject to continuous improvement and modernisation. Improvement not only in methodology, but also in cooperation between organizations can improve benefit–risk assessment.
J.M. Luteijn, B.C. White, H. Gunnlaugsdóttir, F. Holm, N. Kalogeras, O. Leino, S.H. Magnússon, G. Odekerken, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, Ø. Ueland, P.A. McCarron, H. Verhagen: State of the art in benefit–risk analysis: Medicines. Opasnet 2011. [3]. Accessed 22 Aug 2024. This page has also been published elsewhere: Food and Chemical Toxicology 50 (2012) 26–32.
Key words
Benefit–risk assessment, Health technology assessment, Pharmacovigilance, Drug approval/methods, Risk assessment
State of the art in benefit–risk analysis: Food microbiology
S.H. Magnússon, H. Gunnlaugsdóttir, H. van Loveren, F. Holm, N. Kalogeras, O. Leino, J.M. Luteijn, G. Odekerken, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, Ø. Ueland, B.C. White, H. Verhagen: State of the art in benefit–risk analysis: Food microbiology. Food and Chemical Toxicology 50 (2012) 33–39 doi:10.1016/j.fct.2011.06.005
Abstract
Over the past years benefit–risk analysis (BRA) in relation to foods and food ingredients has gained much attention; in Europe and worldwide. BRA relating to food microbiology is however a relatively new field of research. Microbiological risk assessment is well defined but assessment of microbial benefits and the weighing of benefits and risk has not been systematically addressed. In this paper the state of the art in benefit–risk analysis in food microbiology is presented, with a brief overview of microbiological food safety practices.
The quality and safety of foods is commonly best preserved by delaying the growth of spoilage bacteria and contamination by bacterial pathogens. However, microorganisms in food can be both harmful and beneficial. Many microorganisms are integral to various food production processes e.g. the production of beer, wine and various dairy products. Moreover, the use of some microorganisms in the production of fermented foods are often claimed to have beneficial effects on food nutrition and consumer health. Furthermore, food safety interventions leading to reduced public exposure to foodborne pathogens can be regarded as benefits. The BRA approach integrates an independent assessment of both risks and ben- efits and weighs the two using a common currency.
Recently, a number of initiatives have been launched in the field of food and nutrition to address the formulation of the benefit–risk assessment approach. BRA has recently been advocated by EFSA for the public health management of food and food ingredients; as beneficial and adverse chemicals can often be found within the same foods and even the same ingredients. These recent developments in the scoping of BRA could be very relevant for food microbiological issues. BRA could become a valuable methodology to support evaluations and decision making regarding microbiological food safety and public health, sup- plementing other presently available policy making and administrative tools for microbiological food safety management.
S.H. Magnússon, H. Gunnlaugsdóttir, H. van Loveren, F. Holm, N. Kalogeras, O. Leino, J.M. Luteijn,
G. Odekerken, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, Ø. Ueland, B.C. White, H. Verhagen: State of the art in benefit–risk analysis: Food microbiology. Opasnet 2012. [4]. Accessed 22 Aug 2024. This page has also been published elsewhere: Food and Chemical Toxicology 50 (2012) 33–39.
Keywords
Risk assessment, Microbiological risk assessment, Benefit–risk assessment, Food microbiology
Openness in participation, assessment, and policy making upon issues of environment and environmental health: a review of literature and recent project results
Mikko V. Pohjola and Jouni T. Tuomisto: Openness in participation, assessment, and policy making upon issues of environment and environmental health: a review of literature and recent project results. Environmental Health 2011, 10:58 http://www.ehjournal.net/content/10/1/58.
Abstract
Issues of environment and environmental health involve multiple interests regarding e.g. political, societal, economical, and public concerns represented by different kinds of organizations and individuals. Not surprisingly, stakeholder and public participation has become a major issue in environmental and environmental health policy and assessment. The need for participation has been discussed and reasoned by many, including environmental legislators around the world. In principle, participation is generally considered as desirable and the focus of most scholars and practitioners is on carrying out participation, and making participation more effective. In practice also doubts regarding the effectiveness and importance of participation exist among policy makers, assessors, and public, leading even to undermining participatory practices in policy making and assessment.
There are many possible purposes for participation, and different possible models of interaction between assessment and policy. A solid conceptual understanding of the interrelations between participation, assessment, and policy making is necessary in order to design and implement effective participatory practices. In this paper we ask, do current common conceptions of assessment, policy making and participation provide a sufficient framework for achieving effective participation? This question is addresses by reviewing the range of approaches to participation in assessment and policy making upon issues of environment and environmental health and some related insights from recent research projects, INTARESE and BENERIS.
Openness, considered e.g. in terms of a) scope of participation, b) access to information, c) scope of contribution, d) timing of openness, and e) impact of contribution, provides a new perspective to the relationships between participation, assessment and policy making. Participation, assessment, and policy making form an inherently intertwined complex with interrelated objectives and outcomes. Based on experiences from implementing openness, we suggest complete openness as the new default, deviation from which should be explicitly argued, in assessment and policy making upon issues of environment and environmental health. Openness does not undermine the existing participatory models and techniques, but provides conceptual means for their more effective application, and opens up avenues for developing new kinds of effective participatory practices that aim for societal development through collaborative creation of knowledge.
Mikko V. Pohjola, Jouni T. Tuomisto: Openness in participation, assessment, and policy making upon issues of environment and environmental health: a review of literature and recent project results. Opasnet 2011. [5]. Accessed 22 Aug 2024. This page has also been published elsewhere: Environmental Health 2011, 10:58 http://www.ehjournal.net/content/10/1/58.
Keywords
State of the art in benefit–risk analysis: Environmental health
M.V. Pohjola, O. Leino, V. Kollanus, J.T. Tuomisto, H. Gunnlaugsdóttir, F. Holm, N. Kalogeras, J.M. Luteijn, S.H. Magnússon, G. Odekerken, M.J. Tijhuis, Ø. Ueland, B.C. White, H. Verhagen: State of the art in benefit–risk analysis: Environmental health. Food and Chemical Toxicology 50 (2012) 40–55, doi:10.1016/j.fct.2011.06.004
Abstract
Environmental health assessment covers a broad area: virtually all systematic analysis to support decision making on issues relevant to environment and health. Consequently, various different approaches have been developed and applied for different needs within the broad field. In this paper we explore the plurality of approaches and attempt to reveal the state-of-the-art in environmental health assessment by characterizing and explicating the similarities and differences between them. A diverse, yet concise, set of approaches to environmental health assessment is analyzed in terms of nine attributes: purpose, problem owner, question, answer, process, use, interaction, performance and establishment. The conclusions of the analysis underline the multitude and complexity of issues in environmental health assessment as well as the variety of perspectives taken to address them. In response to the challenges, a tendency towards developing and applying more inclusive, pragmatic and integrative approaches can be identified. The most interesting aspects of environmental health assessment are found among these emerging approaches: (a) increasing engagement between assessment and management as well as stakeholders, (b) strive for framing assessments according to specific practical policy needs, (c) integration of multiple benefits and risks, as well as (d) explicit incorporation of both scientific facts and value statements in assessment. However, such approaches are yet to become established, and many contemporarymainstream environmental health assessment practices can still be characterized as relatively traditional risk assessment.
M.V. Pohjola, O. Leino, V. Kollanus, J.T. Tuomisto, H. Gunnlaugsdóttir, F. Holm, N. Kalogeras, J.M. Luteijn, S.H. Magnússon, G. Odekerken, M.J. Tijhuis, Ø. Ueland, B.C. White, H. Verhagen: State of the art in benefit–risk analysis: Environmental health. Opasnet 2012. [6]. Accessed 22 Aug 2024. This page has also been published elsewhere: Food and Chemical Toxicology 50 (2012) 40–55.
Keywords
Environmental healt, Benefit-risk assessment, Impact assessment, Integrated assessment
The health risks and benefits of cycling in urban environments compared with car use: health impact assessment study
David Rojas-Rueda, Audrey de Nazelle, Marko Tainio, Mark J Nieuwenhuijsen: The health risks and benefits of cycling in urban environments compared with car use: health impact assessment study. BMJ 2011;343:d4521 doi:10.1136/bmj.d4521 .
Abstract
Objective: To estimate the risks and benefits to health of travel by bicycle, using a bicycle sharing scheme, compared with travel by car in an urban environment.
Design: Health impact assessment study.
Setting: Public bicycle sharing initiative, Bicing, in Barcelona, Spain.
Participants: 181 982 Bicing subscribers.
Main outcomes: measures The primary outcome measure was all cause mortality for the three domains of physical activity, air pollution (exposure to particulate matter <2.5 μm), and road traffic incidents. The secondary outcome was change in levels of carbon dioxide emissions. Results Compared with car users the estimated annual change in mortality of the Barcelona residents using Bicing (n=181 982) was 0.03 deaths from road traffic incidents and 0.13 deaths from air pollution. As a result of physical activity, 12.46 deaths were avoided (benefit:risk ratio 77). The annual number of deaths avoided was 12.28. As a result of journeys by Bicing, annual carbon dioxide emissions were reduced by an estimated 9 062 344 kg.
Conclusions: Public bicycle sharing initiatives such as Bicing in Barcelona have greater benefits than risks to health and reduce carbon dioxide emissions.
David Rojas-Rueda, Audrey de Nazelle, Marko Tainio, Mark J Nieuwenhuijsen: The health risks and benefits of cycling in urban environments compared with car use: health impact assessment study. Opasnet 2024. [7]. Accessed 22 Aug 2024. This page has also been published elsewhere: BMJ 2011;343:d4521.
Keywords
Air pollution, Environmental issues, Epidemiologic studies, Epidemiology, Public health
Evaluation of intake fractions for different subpopulations due to primary fine particulate matter (PM2.5) emitted from domestic wood combustion and traffic in Finland
Pauliina Taimisto, Marko Tainio, Niko Karvosenoja, Kaarle Kupiainen, Petri Porvari, Ari Karppinen, Leena Kangas, Jaakko Kukkonen, Jouni T. Tuomisto: Evaluation of intake fractions for different subpopulations due to primary fine particulate matter (PM2.5) emitted from domestic wood combustion and traffic in Finland. Air quality, atmosphere & health. Received: 29 October 2009 / Accepted: 8 February 2011 (c) Springer Science+Business Media B.V. 2011 doi:10.1007/s11869-011-0138-3 .
Abstract
Domestic wood combustion and traffic are the two most significant primary fine particulate matter (PM2.5) emission source categories in Finland. We estimated emission–exposure relationships for primary PM2.5 emissions from these source categories using intake fractions (iF), which describes the fraction of an emission that is ultimately inhaled by a target population. The iFs were calculated for four different emission source subcategories in Finland in 2000: (1) domestic wood combustion in residential buildings, (2) domestic wood combustion in recreational buildings, (3) traffic exhaust and wear emissions, and (4) traffic resuspension emissions. The iFs were estimated for both total population and for subpopulations with different gender, age, and educational status. Primary PM2.5 emissions were based on the Finnish Regional Emission Scenario model and the dispersion of particles was calculated using the Urban Dispersion Modeling system of Finnish Meteorological Institute. Both emissions and dispersion were estimated on a 1 km spatial resolution.
Pauliina Taimisto, Marko Tainio, Niko Karvosenoja, Kaarle Kupiainen, Petri Porvari, Ari Karppinen, Leena Kangas, Jaakko Kukkonen, Jouni T. Tuomisto: Evaluation of intake fractions for different subpopulations due to primary fine particulate matter (PM2.5) emitted from domestic wood combustion and traffic in Finland. Opasnet 2024. [8]. Accessed 22 Aug 2024. This page has also been published elsewhere: Air quality, atmosphere & health. Received: 29 October 2009 / Accepted: 8 February 2011 (c) Springer Science+Business Media B.V. 2011.
Keywords
iF, Intake fraction, Exposure, Particulate matter, Domestic combustion, Traffic
Uncertainty in health risks due to anthropogenic primary fine particulate matter from different source types in Finland
M. Tainio, J.T. Tuomisto, J. Pekkanen, N. Karvosenoja, K. Kupiainen, P. Porvari, M. Sofiev, A. Karppinen, L. Kangas, J. Kukkonen: Uncertainty in health risks due to anthropogenic primary fine particulate matter from different source types in Finland. Atmospheric Environment 44 (2010) 2125e2132 doi:10.1016/j.atmosenv.2010.02.036
Abstract
The emission-exposure and exposure-response (toxicity) relationships are different for different emission source categories of anthropogenic primary fine particulate matter (PM2.52.5). These variations have a potentially crucial importance in the integrated assessment, when determining cost-effective abatement strategies. We studied the importance of these variations by conducting a sensitivity analysis for an integrated assessment model. The model was developed to estimate the adverse health effects to the Finnish population attributable to primary PM2.5 emissions from the whole of Europe. The primary PM2.5 emissions in the whole of Europe and in more detail in Finland were evaluated using the inventory of the European Monitoring and Evaluation Programme (EMEP) and the Finnish Regional Emission Scenario model (FRES), respectively. The emission-exposure relationships for different primary PM2.5 emission source categories in Finland have been previously evaluated and these values incorporated as intake fractions into the integrated assessment model. The primary PM2.5 exposure-response functions and toxicity differences for the pollution originating from different source categories were estimated in an expert elicitation study performed by six European experts on air pollution health effects. The primary PM2.5 emissions from Finnish and other European sources were estimated for the population of Finland in 2000 to be responsible for 209 (mean, 95% confidence interval 6e739) and 357 (mean, 95% CI 8e1482) premature deaths, respectively. The inclusion of emission-exposure and toxicity variation into the model increased the predicted relative importance of traffic related primary PM2.5 emissions and correspondingly, decreased the predicted relative importance of other emission source categories. We conclude that the variations of emission-exposure relationship and toxicity between various source categories had significant impacts for the assessment on premature deaths caused by primary PM2.5.
M. Tainio, J.T. Tuomisto, J. Pekkanen, N. Karvosenoja, K. Kupiainen, P. Porvari, M. Sofiev, A. Karppinen, L. Kangas, J. Kukkonen: Uncertainty in health risks due to anthropogenic primary fine particulate matter from different source types in Finland. Opasnet 2010. [9]. Accessed 22 Aug 2024. This page has also been published elsewhere: Atmospheric Environment 44 (2010) 2125e2132.
Keywords
Fine particulate matter, Intake fraction, Exposure-response, Integrated assessment, Sensitivity analysis
Impact of airborne particulate matter on human health: an assessment framework to estimate exposure and adverse health effects in Poland
Marko Tainio, Jaakko Kukkonen, Zbigniew Nahorski: Impact of airborne particulate matter on human health: an assessment framework to estimate exposure and adverse health effects in Poland. Arcghives of environmentl protection vol. 36 no. 1 pp. 95-115, 2010
Abstract
Fine particulate matter (PM2.5) air pollution is one of the main environmental health problems in developed countries. According to modeling estimates the PM2.5 concentrations in Poland are among the highest in Europe. In this article we focus on exposure assessment and estimation of adverse health effects due to PM2.5 air pollution. This article consists of two parts. In the first part, we discuss the main methods used to estimate emission-exposure relationships and adverse health effects due to PM2.5 air pollution. In the second part, we present an assessment framework for Poland. We illustrate this framework by estimating the premature deaths and change in life expectancy in Poland caused by anthropogenic, primary PM2.5 emissions from different European countries, and, in propotion, the premature deaths in different European countries caused by primary PM2.5 emissions from Poland. The PM2.5 emissions were evaluated using the inventory of the European Monitoring and Evaluation Programme (EMEP). The emission-exposure relationships were based on previously published study and the exposure-response functions for PM2.5 air pollution were estimated in expert elicitation study performed for six European experts on air pollution health effects. Based on the assessment, the anthropogenic primary PM2.5 from the whole Europe is estimated to cause several thousand of premature deaths in Poland, annually. There premature deaths are both due to PM2.5 emissions from Poland and transportation of PM2.5 from other European countries, both of these in almost equal parts. The framework is presented in this article will be developed in the near future to a full scale integrated assessment, that takes into account both gaseous and PM2.5 air pollution.
Marko Tainio, Jaakko Kukkonen, Zbigniew Nahorski: Impact of airborne particulate matter on human health: an assessment framework to estimate exposure and adverse health effects in Poland. Opasnet 2010. [10]. Accessed 22 Aug 2024. This page has also been published elsewhere: Arcghives of environmentl protection vol. 36 no. 1 pp. 95-115, 2010.
Keywords
Fine particulate matter, PM2.5, exposure, intake fraction, integrated assessment, Poland
State of the art in benefit–risk analysis: Food and nutrition
M.J. Tijhuis, N. de Jong, M.V. Pohjola, H. Gunnlaugsdóttir, M. Hendriksen, J. Hoekstra, F. Holm, N. Kalogeras, O. Leino, F.X.R. van Leeuwen, J.M. Luteijn, S.H. Magnússon, G. Odekerken, C. Rompelberg, J.T. Tuomisto, Ø. Ueland, B.C. White, H. Verhagen: State of the art in benefit–risk analysis: Food and nutrition. Food and Chemical Toxicology 50 (2012) 5–25 doi:10.1016/j.fct.2011.06.010
Abstract
Benefit–risk assessment in food and nutrition is relatively new. It weighs the beneficial and adverse effects that a food (component) may have, in order to facilitate more informed management decisions regarding public health issues. It is rooted in the recognition that good food and nutrition can improve health and that some risk may be acceptable if benefit is expected to outweigh it. This paper presents an overview of current concepts and practices in benefit–risk analysis for food and nutrition. It aims to facilitate scientists and policy makers in performing, interpreting and evaluating benefit–risk assessments.
Historically, the assessments of risks and benefits have been separate processes. Risk assessment is mainly addressed by toxicology, as demanded by regulation. It traditionally assumes that a maximum safe dose can be determined from experimental studies (usually in animals) and that applying appropriate uncertainty factors then defines the ‘safe’ intake for human populations. There is a minor role for other research traditions in risk assessment, such as epidemiology, which quantifies associations between determinants and health effects in humans. These effects can be both adverse and beneficial. Benefit assessment is newly developing in regulatory terms, but has been the subject of research for a long time within nutrition and epidemiology. The exact scope is yet to be defined. Reductions in risk can be termed benefits, but also states rising above ‘the average health’ are explored as benefits. In nutrition, current interest is in ‘optimal’ intake; from a population perspective, but also from a more individualised perspective.
In current approaches to combine benefit and risk assessment, benefit assessment mirrors the traditional risk assessment paradigm of hazard identification, hazard characterization, exposure assessment and risk characterization. Benefit–risk comparison can be qualitative and quantitative. In a quantitative comparison, benefits and risks are expressed in a common currency, for which the input may be deterministic or (increasingly more) probabilistic. A tiered approach is advocated, as this allows for transparency, an early stop in the analysis and interim interaction with the decision-maker. A general problem in the disciplines underlying benefit–risk assessment is that good dose–response data, i.e. at relevant intake levels and suitable for the target population, are scarce.
It is concluded that, provided it is clearly explained, benefit–risk assessment is a valuable approach to systematically show current knowledge and its gaps and to transparently provide the best possible science-based answer to complicated questions with a large potential impact on public health.
M.J. Tijhuis, N. de Jong, M.V. Pohjola, H. Gunnlaugsdóttir, M. Hendriksen, J. Hoekstra, F. Holm, N. Kalogeras, O. Leino, F.X.R. van Leeuwen, J.M. Luteijn, S.H. Magnússon, G. Odekerken, C. Rompelberg, J.T. Tuomisto, Ø. Ueland, B.C. White, H. Verhagen: State of the art in benefit–risk analysis: Food and nutrition. Opasnet 2012. [11]. Accessed 22 Aug 2024. This page has also been published elsewhere: Food and Chemical Toxicology 50 (2012) 5–25.
Keywords
Benefit–risk, Benefit, Risk, Food, Nutrition
Looking beyond borders: Integrating best practices in benefit–risk analysis into the field of Food and Nutrition
M.J. Tijhuis, M.V. Pohjola, H. Gunnlaugsdóttir, N. Kalogeras, O. Leino, J.M. Luteijn, S.H. Magnússon, G. Odekerken-Schröder, M. Poto, J.T. Tuomisto, Ø. Ueland, B.C. White, F. Holm, H. Verhagen: Looking beyond borders: Integrating best practices in benefit–risk analysis into the field of Food and Nutrition. Food and Chemical Toxicology 50 (2012) 77–93 doi:10.1016/j.fct.2011.11.044
Abstract
An integrated benefit–risk analysis aims to give guidance in decision situations where benefits do not clearly prevail over risks, and explicit weighing of benefits and risks is thus indicated. The BEPRARIBEAN project aims to advance benefit–risk analysis in the area of food and nutrition by learning from other fields. This paper constitutes the final stage of the project, in which commonalities and differences in benefit–risk analysis are identified between the Food and Nutrition field and other fields, namely Medicines, Food Microbiology, Environmental Health, Economics and Marketing–Finance, and Consumer Perception. From this, ways forward are characterized for benefit–risk analysis in Food and Nutrition. Integrated benefit–risk analysis in Food and Nutrition may advance in the following ways: Increased engagement and communication between assessors, managers, and stakeholders; more pragmatic problem-oriented framing of assessment; accepting some risk; pre- and post-market analysis; explicit communication of the assessment purpose, input and output; more human (dose–response) data and more efficient use of human data; segmenting populations based on physiology; explicit consideration of value judgments in assessment; integration of multiple benefits and risks from multiple domains; explicit recognition of the impact of consumer beliefs, opinions, views, perceptions, and attitudes on behaviour; and segmenting populations based on behaviour; the opportunities proposed here do not provide ultimate solutions; rather, they define a collection of issues to be taken account of in developing methods, tools, practices and policies, as well as refining the regulatory context, for benefit–risk analysis in Food and Nutrition and other fields. Thus, these opportunities will now need to be explored further and incorporated into benefit–risk practice and policy. If accepted, incorporation of these opportunities will also involve a paradigm shift in Food and Nutrition benefit–risk analysis towards conceiving the analysis as a process of creating shared knowledge among all stakeholders.
M.J. Tijhuis, M.V. Pohjola, H. Gunnlaugsdóttir, N. Kalogeras, O. Leino, J.M. Luteijn, S.H. Magnússon, G. Odekerken-Schröder, M. Poto, J.T. Tuomisto, Ø. Ueland, B.C. White, F. Holm, H. Verhagen: Looking beyond borders: Integrating best practices in benefit–risk analysis into the field of Food and Nutrition. Opasnet 2012. [12]. Accessed 22 Aug 2024. This page has also been published elsewhere: Food and Chemical Toxicology 50 (2012) 77–93.
Keywords
Benefit–risk, Food & nutrition, Best practice, Assessment, Management, Shared understanding
State of the art in benefit–risk analysis: Consumer perception
Ø. Ueland, H. Gunnlaugsdottir, F. Holm, N. Kalogeras, O. Leino, J.M. Luteijn, S.H. Magnússon, G. Odekerken, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, B.C. White, H. Verhagen: State of the art in benefit–risk analysis: Consumer perception. Food and Chemical Toxicology 50 (2012) 67–76 doi:10.1016/j.fct.2011.06.006
Abstract
Benefit and risk perception with respect to food consumption, have been a part of human daily life from beginning of time. In today’s society the food chain is long with many different types of actors and low degree of transparency. Making informed food choices where knowledge of benefits and risks is part of the decision making process are therefore complicated for consumers. Thus, to understand how consumers perceive benefits and risks of foods, their importance in relation to quality evaluations are aspects that need to be addressed. The objective of this paper is to discuss state of the art in understanding consumer perceptions of benefits and risks of foods in order to improve understanding of consumer behaviour in the food domain.
Risks may be associated with both acute and long term consequences, some of which may have serious effects. Perceived risks are connected to morbidity and mortality along two dimensions relating to unknown risk, and to which extent the risk is dreaded by the consumer. Unfamiliar, uncertain, unknown, uncontrollable, and severe consequences are some factors associated with risk perception. Novel food processing techniques, for instance, score high on several of these parameters and are consequently regarded with suspicion and perceived as risky by consumers.
On a daily basis, benefits of foods and food consumption are more important in most consumers’ minds than risks. Benefits are often associated with food’s ability to assuage hunger, and to provide pleasure through eating and socialising. In addition, two main categories of benefits that are important for acceptance of product innovations are health and environmental benefits.
Benefit and risk perception of foods seem to be inversely correlated, so when something is perceived as being highly beneficial, it is correspondingly perceived as having low risk. However, slightly different paths are used in the formation of these perceptions; benefit perception is based on heuristics and experience, while risk perception is to a larger extent the result of cognitive information processing. Consumers are particularly conservative when it comes to perception and acceptance of foods compared to other products. Benefit-risk evaluations tend to be skewed towards acceptance of all that is traditional and well-known (benefits), and rejection or suspicion towards anything that is novel or highly processed (risks) regardless of actual risk. Knowledge of how consumers perceive benefits and risks of foods, may contribute to understanding benefit-risk perception in other areas related to personal, societal or environmental perspectives.
Ø. Ueland, H. Gunnlaugsdottir, F. Holm, N. Kalogeras, O. Leino, J.M. Luteijn, S.H. Magnússon, G. Odekerken, M.V. Pohjola, M.J. Tijhuis, J.T. Tuomisto, B.C. White, H. Verhagen: State of the art in benefit–risk analysis: Consumer perception. Opasnet 2012. [13]. Accessed 22 Aug 2024. This page has also been published elsewhere: Food and Chemical Toxicology 50 (2012) 67–76.
Keywords
Consumer behaviour, Risk perception, Benefit perception
State of the art in benefit–risk analysis: Introduction
H. Verhagen, M.J. Tijhuis, H. Gunnlaugsdottir, N. Kalogeras, O. Leino, J.M. Luteijn, S.H. Magnússon, G. Odekerken, M.V. Pohjola, J.T. Tuomisto, Ø. Ueland, B.C. White, F. Holm: State of the art in benefit–risk analysis: Introduction. Food and Chemical Toxicology 50 (2012) 2–4 doi:10.1016/j.fct.2011.06.007
Abstract
Risk-taking is normal in everyday life if there are associated (perceived) benefits. Benefit-Risk Analysis (BRA) compares the risk of a situation to its related benefits and addresses the acceptability of the risk. Over the past years BRA in relation to food and food ingredients has gained attention. Food, and even the same food ingredient, may confer both beneficial and adverse effects. Measures directed at food safety may lead to suboptimal or insufficient levels of ingredients from a benefit perspective. In BRA, benefits and risks of food (ingredients) are assessed in one go and may conditionally be expressed into one currency. This allows the comparison of adverse and beneficial effects to be qualitative and quantitative. A BRA should help policy-makers to make more informed and balanced benefit-risk management decisions. Not allowing food benefits to occur in order to guarantee food safety is a risk management decision much the same as accepting some risk in order to achieve more benefits. BRA in food and nutrition is making progress, but difficulties remain. The field may benefit from looking across its borders to learn from other research areas. The BEPRARIBEAN project (Best Practices for Risk-Benefit Analysis: experience from out of food into food; [14]) aims to do so, by working together with Medicines, Food Microbiology, Environmental Health, Economics & Marketing-Finance and Consumer Perception. All perspectives are reviewed and subsequently integrated to identify opportunities for further development of BRA for food and food ingredients. Interesting issues that emerge are the varying degrees of risk that are deemed acceptable within the areas and the trend towards more open and participatory BRA processes. A set of 6 ‘state of the art’ papers covering the above areas and a paper integrating the separate (re)views are published in this volume.
H. Verhagen, M.J. Tijhuis, H. Gunnlaugsdottir, N. Kalogeras, O. Leino, J.M. Luteijn, S.H. Magnússon, G. Odekerken, M.V. Pohjola, J.T. Tuomisto, Ø. Ueland, B.C. White, F. Holm: State of the art in benefit–risk analysis: Introduction. Opasnet 2012. [15]. Accessed 22 Aug 2024. This page has also been published elsewhere: Food and Chemical Toxicology 50 (2012) 2–4.
Keywords
Benefit-risk, Best practice, BEPRARIBEAN