Involving stakeholders and developing a policy for stakeholder involvement in the European network for health technology assessment, EUnetHTA.

OBJECTIVES: This article explains how the issue of stakeholder involvement was addressed in the European network for Health Technology Assessment (EUnetHTA) Project and describes the structures of future stakeholder involvement in the EUnetHTA Collaboration. METHODS: Initiatives led to a dialogue with stakeholders and exchanging views and expectations on health technology assessment (HTA) processes and the future development of EUnetHTA. The methods of involving different stakeholder groups in EUnetHTA included general information to stakeholders about EUnetHTA, targeted information on a Web site, analysis of stakeholder opinions on HTA and EUnetHTA, and development of a draft stakeholder policy. RESULTS: First steps were taken to organize processes to consolidate the legitimacy of EUnetHTA and its products and encourage the representation of interests, thus contributing to promoting the utilization of HTA in national/regional policy making. A stakeholder Web site, analyses of stakeholder opinions on HTA and EUnetHTA in a discussion topic catalog, and a draft stakeholder policy resulted from the work. CONCLUSIONS: Stakeholder involvement in EUnetHTA is necessary to ensure the legitimacy and prospects for utilization of EUnetHTA and its products. The described activities and results create the foundation for a continued dialogue with, and involvement of, stakeholders. The EUnetHTA stakeholder meeting can be considered as a successful experience of dialogue between EUnetHTA and stakeholders, which should be continued. Our experience shows the challenge of obtaining balanced stakeholder representation across the identified stakeholder groups. Continued attention should be given to achieving balanced stakeholder representation.

Practical tools and methods for health technology assessment in Europe: structures, methodologies, and tools developed by the European Network for Health Technology Assessment, EUnetHTA.

OBJECTIVES: This article presents an overview of the practical methods and tools to support transnational Health Technology Assessment (HTA) that were developed and pilot tested by the European network for HTA (EUnetHTA), which involved a total of sixty-four Partner organizations. METHODS: The methods differ according to scope and purpose of each of the tools developed. They included, for example, literature reviews, surveys, Delphi and consensus methods, workshops, pilot tests, and internal/public consultation. RESULTS: Practical results include an HTA Core Model and a Handbook on the use of the model, two pilot examples of HTA core information, an HTA Adaptation Toolkit for taking existing reports into new settings, a book about HTA and health policy making in Europe, a newsletter providing structured information about emerging/new technologies, an interactive Web-based tool to share information about monitoring activities for emerging/new technologies, and a Handbook on HTA capacity building for Member States with limited institutionalization of HTA. CONCLUSIONS: The tools provide high-quality information and methodological frameworks for HTA that facilitate preparation of HTA documentation, and sharing of information in and across national or regional systems. The tools will be used and further tested by partners in the EUnetHTA Collaboration aiming to (i) help reduce unnecessary duplication of HTA activities, (ii) develop and promote good practice in HTA methods and processes, (iii) share what can be shared, (iv) facilitate local adaptation of HTA information, (v) improve the links between health policy and HTA.

The environmental health of children: priorities in Europe.

OBJECTIVES: To evaluate existing research on the environmental health of children and provide a prioritised list of risk factors and policy recommendations for action, the Policy Interpretation Network on Children's Health and Environment (PINCHE) was set up within EU FP5 (QLK4-2002-02395). The project focused on air pollutants, carcinogens, neurotoxicants and noise. PINCHE was a multidisciplinary and multinational network of representatives from science, industry, NGOs, and consumer and patient organisations in Europe. MATERIALS AND METHODS: A literature search was performed using the Pubmed, Embase and Toxline databases. The quality of the gathered articles was assessed and their information and relevance was interpreted within a systematic framework. Information related to exposure, epidemiology, and toxicology was analysed separately and then a risk evaluation of particular environmental factors was made. Socioeconomic factors were specifically taken into account. The results were compiled, and considering the present regulatory situation, policy recommendations for action were made. Finally, the risk factors and policy recommendations were prioritised through a process of discussion between all the partners. RESULTS AND CONCLUSIONS: PINCHE concluded that outdoor air pollutants (especially traffic-related), environmental tobacco smoke, allergens, and mercury were high priorities with an urgent need for action. Brominated flame retardants, lead, PCBs and dioxins, ionising and solar radiation, and some noise sources were classified as being of medium priority. Some toxins were given low priority, based on few exposed children, relatively mild health effects or an improving situation due to past policy measures. We recognise the shortcomings of such a prioritisation and, though some measures are more urgent than others, emphasise that ideally all policy measures should be carried out without delay for all toxins. This priority list must be continuously revised, the precautionary principle should be central to all decisions, and the focus should be on safe exposure levels for children.

Policy Interpretation Network on Children's Health and Environment.

AIM: The main objective of PINCHE is to provide policy recommendations aiming at protecting children's health and environment based on completed scientific research. The project focused on four themes: indoor and outdoor air pollutants, carcinogens, neurotoxicants, and noise. The data were evaluated in workpackages on exposure assessment, epidemiology, toxicology, and risk and health impact assessment. The data were analysed according to a framework of questions. The workpackage on socioeconomic factors studied the influence of socioeconomic status on exposures and on health effects. In the workpackage on science-policy interface, recommendations on how to improve children's environmental health were formulated. RESULTS: The policy recommendations resulting from the analysis were grouped according to relevant policy levels: European Commission or the European Parliament, member states and other stakeholders at regional or local level. These recommendations are general guidelines for taking action. Regional differences and variation must be reflected when policy is actually implemented. In addition, recommendations related to education and personal behaviour are presented in the reports. CONCLUSIONS: The policy recommendations are important input for policy advisers, policy makers and public health authorities at all policy levels. The recommendations are also of direct relevance to interest groups, such as environmental NGOs including child health and advocacy groups. The policy recommendations for each policy level were prioritized. High priorities were given to reduce exposure to environmental tobacco smoke, transport related air pollution, indoor air and mercury.

PINCHE's policy recommendations on noise: how to prevent noise from adversely affecting children.

BACKGROUND: Noise can have auditory and non-auditory effects on children. Very few noise episodes affect children's hearing instantaneously; most effects are long-term and cumulative. Describing the risks of noise on children's health and well-being in a life-course perspective can illustrate the prospects of cumulative effects. CONCLUSION: The policy recommendations the Policy Interpretation Network on Children's Health and Environment (PINCHE) prepared for each age group or setting are described here.

Children's environmental health: why should social disparities be considered?

BACKGROUND/METHODS: The aim of workpackage 5 'Environmental exposures and children's health: impact of socioeconomic factors' in the EU-funded network PINCHE (Policy Interpretation Network on Children's Health and Environment) was to review and interpret the current knowledge of social inequalities in environmental exposures and children's health. Socioeconomic factors may impact on children's environmental health in two ways: 1) environmental exposures may differ according to socioeconomic status; 2) given a certain level of harmful environmental exposure, socioeconomic factors may modify the health effects by influencing the susceptibility characteristics of children. RESULTS: There is a lack of information to evaluate and quantify the effect of socioeconomic factors on environmental exposures and children's health in Europe. In most circumstances there seems to be an inverse social gradient with increased burden concerning exposures and health outcomes in children of lower social status. CONCLUSIONS: There is a need to improve research on social inequalities in children's health and environment. Because of the complexity, integrated approaches and a combination of different intervention measures and policies are necessary to reduce environmental exposure and adverse health effects in children. Paediatricians may contribute to improvement of children's environmental health by risk communication and health advocacy at community and governmental level.

Policy and science in children's health and environment: recommendations from the PINCHE project.

BACKGROUND: Policy recommendations result from the discussions and analysis of the present situation in environment and health. Such analysis was performed in PINCHE. This led to recommendations based on the scientific literature. In the field of children's environmental health the policy process will follow more or less fixed rules, but this process is still at an early level of development. The link between science and policy still faces many challenges. Scientific assessment of environmental risk must recognize and tackle the problems of data sets, variability of human and environmental systems, the range, spatial and temporal diffusion of potential health effects and many biases and confounding factors. RESULTS: The PINCHE network recommends a general improvement of the supporting scientific fields in environment and health. Assessments from epidemiology or toxicology should play a key role in influencing science-policy decisions in programmes that are intended to inform the public policy process. Scientific committees at a local level could play a role. The relation between health and environment needs to be better incorporated in training and education. There is a need for harmonization of data production and use. The priorities in PINCHE focus on the most important issues. A classification of low, medium or high priority for action was used to describe a range of different environmental stressors. CONCLUSIONS: PINCHE provided recommendations to reduce exposure for children. Exposure reduction is not always linked to improved health in the short term, but it will reduce the body burden of accumulating chemicals in children. A strategic choice is reduction of exposure of children to compounds by changing production techniques or by increasing the distance of child specific settings to sources. The contribution of all players in the production, distribution and use of scientific knowledge in the field of children's environmental health is necessary.

Today's epidemics in children: possible relations to environmental pollution and suggested preventive measures.

BACKGROUND: Facts and hypotheses on the relationship between some children's diseases or disorders and external stressors during the developmental stage of a child, both prenatally and postnatally are described in literature. In this paper the following changes in patterns and causes of the main childhood illnesses are summarized and recommendations for actions are made. Prematurity. Intra-uterine growth restriction. Testicular dysgenesis syndrome. Type I and Type II diabetes. Asthma, atopy and hay fever. Autism. Attention deficit hyperactivity disorder (ADHD). Learning disabilities. Cancer. Obesity. Hearing problems. RESULTS: Literature provides a growing amount of information on changing patterns in childhood diseases. CONCLUSIONS: The following recommendations for action are formulated: Immediate research on endocrine disrupters in relation to prematurity. Diabetes: avoid Maillard Compounds in liquid baby food and in food in general: promote breastfeeding. Asthma: avoid exposure to smoking, the use of chemical household products, dioxin and dioxin-like chemicals, and avoid air pollution with high levels of particulate matter, especially around conception, during pregnancy and in the first years of life. Autism: more research on incidence and causes. ADHD and learning disabilities: more research on prevalence and causes. Preventions: 1) preconception counselling to avoid potentially harmful substances; 2) controlling and further lowering levels of polychlorinated biphenyls, lead and methyl mercury. Cancer: promote breastfeeding, carry out research into effects of foetal exposure to internal fission-product radionuclides. Obesity: stop smoking in pregnancy, avoid parental obesity, longer night sleep. Hearing problems: lower noise levels in discothèques, promote the day-evening-night level to avoid noise (longer night sleep).

Exposure to multiple environmental agents and their effect.

INTRODUCTION: All children are exposed to multiple physical, chemical and biological challenges that can result in adverse health effects before and after birth. In this context, the danger of multiple exposures cannot be assessed from a single-chemical approach as used in classical toxicology. AIM: To open up a 'negotiation space' for the problem of multiple exposure to environmental stressors, defined as any physical, chemical or biological entity that can induce an adverse response. In this context, two further questions obtain: to what extent can synergistic risks be assessed, and how far could potential adverse effects be prevented by enhanced regulation? METHODS: A discussion of two general approaches is taken: 1) the investigation of mixtures such as smoking or air pollution without specifying the individual agents, and 2) the investigation of individual substances with a focus on possible interactions in the context of dose to receptor. RESULTS: Although mixtures of compounds can have effects, it may not be possible to ascribe causation to a single compound. Furthermore, cumulative low-dose insult can, in some circumstances, be more toxic than a single high-dose exposure, e.g. endocrine disruptive effects of a combination of PCBs and dioxins which disrupt the thyroid hormone status; this tends to contradict elements of classical toxicology, . These cumulative insults may further combine with heavy metals and can disrupt the heme synthesis. It is possible that groups of pollutants could be used to test their cumulative capacity to multiple stress-susceptible receptor targets as is done in smoking and air pollution. This methodology could be used for further groups of potential pollutants, for example those associated with cleaning products, or cosmetics. Testing individual substances with a focus on interactions means that not only chemicals but also concurrent diseases should be taken into account. We suggest that the enhanced regulation of potential multiple stressors falls into two discrete categories. The first comprises a more precautionary approach (as demonstrated by the banning of chemicals such as some brominated flame retardants in Europe). The second comprises a more 'permissive' liberal approach involving the initial study of an individual compound, and subsequent interrogation of that compound in combination with another (as demonstrated by lowering the carcinogenicity of aflatoxin by vaccination against hepatitis B). CONCLUSIONS: It is necessary to define and study groups of multiple stressors as in US EPA's Framework for Cumulative Risk Assessment (U.S. EPA 2003). Recent increased knowledge of the greater sensitivity of the unborn baby, the infant and the child, has led to general recognition that a higher degree of precaution is now needed in regulating for multiple stressors on the young. The more liberal permissive approach proceeding from established effects of the individual exposures is becoming less acceptable now that we know that there is much we do not understand about chronic effects of stressors during the early development phases. Conflicts over which approach to take may have to be resolved through engagement and negotiation with a wide community of stakeholders. This "community of interest" may include fundamental research scientists, practicing clinical paediatricians, patient groups, and others concerned with the health and wellbeing of infants and children.