In early May 2008, Cyclone Nargis (CN) tore across the southern coastal regions of Myanmar, pushing a tidal surge through villages and rice paddies. The almost 12 foot wall of water and wind speed of over 200 km/hr killed tens of thousands of people and left hundreds of thousands homeless and vulnerable to injury and disease. Out of the 7.35 million living in the affected townships of Labutta, Bogale, Pyinsalu, Yangon, and many more, approximately 2.4 million were affected. Overall, more than 50 townships were affected by this most devastating cyclone in Asia since 1991. The Delta region, Myanmar's Rice Bowl, was severely damaged. The low-lying villages were submerged. There was widespread destruction of homes, critical infrastructure of the villages, roads, ferries, water, fuel, and electricity supplies. Our team from Singapore  reached out to at least 10 different villages during the time we were there. We ran mobile clinics daily at several locations and these operated from warehouses, temples, schools or any make shift buildings. The journey to the remote villages may take between 1 and 2 hours by road or by boat. We also ran mobile clinics at the township hospital, the rural healthcare centers, and an orphanage. Besides the many benefits of the ocean, population living in coastal regions is at risk for meteorological and seismic hazards that originate from the seas. Tropical cyclones and tsunamis represent the most powerful and destructive of all marine hazards. Disasters such as these can expose the vulnerabilities in the capabilities of healthcare and community infrastructure to respond to them.2In early May 2008, Cyclone Nargis (CN) tore across the southern coastal regions of Myanmar, pushing a tidal surge through villages and rice paddies. The almost 12 foot wall of water and wind speed of over 200 km/hr killed tens of thousands of people and left hundreds of thousands homeless and vulnerable to injury and disease.Out of the 7.35 million living in the affected townships of Labutta, Bogale, Pyinsalu, Yangon and many more, approximately 2.4 million were affected. Overall, more than 50 townships were affected by this most devastating cyclone in Asia since 1991. The Delta region, Myanmar's Rice Bowl, was severely damaged . The low3preparedness of a nation to handle a large scale crisisbasic human rights issuecommunity empowermentdefinition of basic healthcare needs of a nation andissues of environmental educationThe Delta region is exposed to disasters like floods, tsunamis, cyclones as well as fire hazards. CN is one of the most controversial disasters, bringing forth issues of:5prepareBesides the disaster, social and political are also the other issues Myanmar is facing. More than 50 years of internal conflict have led many citizens to forced migration. It is estimated that there are about 1 million people who are internally displaced and more than 1 million Myanmese refugees. About 155,000 of these refugees live in 9 official camps at the Thai-Myanmar border.4Despite the fact stated that 2.2% of Myanmar GDP was spent on healthcare, basic healthcare services were virtually nonexistent in the villagers and rural areas. Where available, they were rudimentary and access to the majority of the population was limited. The general level of healthcare awareness was very low and public health education was lacking. They generally have no access to clean drinking water and there is little sanitation services in the rural area.7The State Peace and Development Council spend less than US$1 (i.e. 60 cents) per person per year, on healthcare. Approximately, 1 in 4 households live below the poverty line. There are important disparities between the rural and urban areas and 70% of the population resides in the former. Many in the villages, including pregnant women and children, have substandard diet. Across Myanmar, about 40% of children fewer than 5 years have stunted growth and about 30% are underweight. There was a general lack of medication and if available, there was often sharing and splitting of these medications with others, making prescribed treatment ineffective. The use of traditional medicine is also very widespread and forms an integral part of the country's health services.Malaria is the leading cause of morbidity and mortality with over 538,000 cases and 1,647 deaths reported in 2006. Dengue and dengue haemorrhagic fever cases have seasonal epidemics. Myanmar is also among the 22 countries with the highest burden of tuberculosis. An estimated 1.6% of the population is infected annually.Pregnancy related deaths represent the leading cause of mortality amongst women of reproductive age group. The maternal mortality ranges from 230 to 580 per 100,000 live births.3676For every 1,000 population, there are currently 0.36 doctors, 0.2 nurses, 0.79 midwives, and 0.99 general healthworker. The corresponding figures for USA would be, 2.56 doctors, 9.37 nurses, 1.63 midwives and 20.96 healthcare worker per 1,000 citizens.[A National Health Plan 2006-2011 has been developed to improve healthcare, response and fairness in the distribution of financial contributions. This national strategic plan has been formulated for reproductive health, child health, adolescent health, HIV/AIDS, tuberculosis and malaria control, water supply, sanitation and hygiene. Generally, World Health Organisation (WHO), UNICEF (United Nation Children's Fund), and UNDP (United nations Development Programme) contribute to many health related activities and programmes in Myanmar.6Following the disaster, Team Singapore was formed. The team comprised of members/volunteers from different local nongovernmental organizations (NGOs such as The Singapore Red Cross and Mercy Relief) and healthcare institutions. The choice and numbers of personnel was decided based on updates and ground reports, media reports and other verified feedback received, pertaining to possible injuries, number of casualties, expected procedures and diseases, among other considerations. As these NGOs and institutions usually have their own standard operating procedures (SOP) and logistics, equipment and drug listings, these have to be aligned for Team Singapore, in the response to CN.The team also had discussions and worked with many other local groups who wanted to make their representations felt and contribute in terms of manpower, money or other resources. For example, interpreters, which is an essential service required by the team, came from immigrants or expatriats from Myanmar who worked in Singapore. It is also mandatory to establish good and reliable ground contact with local hosts in Myanmar, as this will facilitate entry, transfer of equipment and aid, as well as other documentary arrangements. This could be in the form of a local NGO in the receiving country or other local associations. Communications and keeping up to date with organizations such as World Food Programme, the United Nations and UNHCR (United Nations High Commissioner for Refugee) too is important.Vaccination for team members, psychological preparedness counseling and briefing by Foreign Affairs staff were compulsory. Packing of drugs and equipments, to ensure sufficient stock to function for up to a week was also done. The plan was to procure the rest of the drugs and equipment in Yangon. Cargo and air freight arrangements as well as local transportation in Myanmar were secured on a preliminary basis.All set to go, member's spirits were indeed high, wanting to impact a change in the lives of those affected.Transition Phase management. This was defined as the efforts required between the rescue and rehabilitation phase.Short-term rebuilding. This was defined as the rapid improvement which could be made in both the urban and rural areas to have farmers and fishermen resume their livelihood as soon as possible.Longer term rebuilding. This was to cover reconstruction and resettlement.Preparedness and prevention. Here, it was suggested that the local authorities studied and looked into some form of early warning system, mechanism for mobilization, construction of stronger facilities and infrastructure, storm resistant roads and embankments, storm shelters and regeneration of the mangrove forests.On arrival in Yangon, there were discussions with the local authorities. The Prime Minister's office in Yangon took charge of the National Natural Disaster Preparedness Coordinating Committee which was set up in response to CN. This committee was chaired by the Prime Minister himself. Various subcommittees were also formed by the local government to oversee various areas pertaining to the post disaster period. These committees were to plan a comprehensive programme for reconstruction and this was to comprise of the following:TransitiTeam Singapore was allocated the Twante Township , just toAs in any disasters, the priority for the medical team was to manage the primary casualties (those with direct effect and injuries from CN) as well as the secondary casualties .In the early phase, needs of the victims were highest for basic survival commodities as well as basic healthcare needs. The former would comprise of food, water, shelter and blankets whilst the latter involve front and first line care as well as more definitive care which can be provided by international or local humanitarian teams at field clinics, hospitals or more definitive institutions, if these had been preserved.Team Singapore faced a unique situation in the work to be carried out. Unlike other large scale disasters where multiple local and international NGOs and organizations work together at Ground Zero, often coordinated by the United Nations. In Myanmar, each team was designated a specific locality/township to work in and given a local liaison officer, who helped to facilitate and coordinate the teams activities. He may also act as the interpreter.Team Singapore reached out to at least 10 different villages/rural areas during the time we were there. We ran mobile clinics daily at several locations and these operated from warehouses, temples, schools or any make shift buildings Figures –7. The jWe also ran mobile clinics at the township hospital, the rural healthcare centers and an orphanage.For the 9 operational days, Team Singapore treated a total of 4,710 patients . Adults There was also a significant proportion of paediatric patients who had nonspecific complaints i.e. giddiness (2.7%), headache (4.5%), and musculoskeletal pain (4.9%).In the category ‘others’, diagnoses comprised of complaints such as passage of worms per rectal, request for vitamins and health supplements, failure to thrive, convulsions, joint swelling, malaria and request for X-rays or blood tests.After the operations, the necessary follow up was planned. This comprised on medium term projects such as water treatment and desalination, rebuilding of schools and dormitories, assistance with emergency and disaster preparedness. The networks established with the local contacts and authorities become very important for subsequent follow up and planning of programmes for execution. Other health related issues which needed handing over were passed on to the local doctors and healthcare staff as well as the international volunteers, such as those from the UN, and UNICEF who would be staying on for a prolonged period.Tropical cyclones are low pressure weather systems that develop over the warm waters of the ocean typically between latitudes 30 degrees North and South. As warm water is necessary to power cyclone formation, only the mid section of the planet can conceive them. A corollary is that cyclones neither form at nor cross the equator.10The public health consequences of cyclones such as CN is tremendous; high mortality rates, widespread loss of clean water, food and supplies, electricity, increased pests and vectors as well as possible toxic exposures.Disease surveillance have shown that there is an increase number of self-limiting gastrointestinal and respiratory tract illnesses after the cyclone.1112 Thes11Chronic illnesses such as asthma and emphysema have been known to be exacerbated after disasters. However, these were not commonly seen in the population studied in Twante Township.Injuries, according to some reports, represent the commonest cause of death and the primary cause of morbidity from a tropical cyclone. In fact, the top three causes of cyclone-related injuries are laceration, blunt trauma and puncture wounds, with about 80% of these injuries confined to the lower extremities.14 In thiA WHO report stated there was a great need for psychological support.In our own series, this was 8.1% and 2.8% in adults and children under 12 years, respectively. Some examples of the presentation included direct complaints of fear and recurring memories of the effects of the cyclone, whilst others presented with headache, giddiness, insomnia, palpitations and a range of other somatization symptoms (bodily aches and pains of no other causes). In these cases, the person may come in and complain of a specific symptom and upon further clarification of the history and examination, there may be no obvious organic diagnoses. Thus, there is the need to probe further into the history. This is where interpreters come in handy especially for foreign medical teams. Amongst the paediatric patients, presentation came in the form of screaming at night and crying, fear of being or sleeping alone (whilst they used to do this before the cyclone), refusal to feed, refusal to go out of the house or to get to school due to fear, not wanting to go near the sea/river and so on. This also depends on the age group of the child. At the orphanage we visited, the majority of the children were psychologically traumatized as there were several deaths from among their friends and there were several ‘new’ children being transferred in as they had lost both their parents to CN.In counseling these cases, it could be a ‘one to one’ counseling with the presence of an interpreter or, group counseling, such as the one done for the children at the orphanage we visited. The latter was done through the use of drawing therapy, group interactive interviews and simple games. As Team Singapore was only there for two weeks, we empowered the teachers at the orphanage and local volunteers on how to continue with the sessions. There was also a group from UNICEF who was there on a longer term basis who would continue with the counseling and therapyPrevention of morbidity and mortalityProvision of timely care for victimsEnsuring restoration of health and health services as soon as possibleProtection of staff and respondersManagement of adverse climatic and environmental conditionsPreparedness is the key to preserving human health in the event of cyclones and tsunamis. Many may even argue that this is a basic human right. Absence of emergency preparedness will result in death happening immediately during the impact phase, where emergency response activities are most vulnerable and least capable. Preparedness is the aggregate of all the measures and policies taken by humans before an event occurs that reduces the negative impact that would otherwise have been caused by the event. This would comprise of activities such as risk assessment, planning, hazards monitoring, early warning and population protection measures.15 The obPreventive and protective measures are the most efficacious actions which can be taken to protect human health from the hazards of cyclones and tsunamis, but they also are the most consistent with the promotion of human dignity and development.In countries affected by disasters, local government often have to take the initiative to make certain policy changes or implement programmes and training, in alignment with being prepared as a community. For example, the New Zealand government instituted a new policy of disaster response in an attempt to bring about change and development in the relatively remote agricultural region which was struck by a severe cyclone in 1988.Although the Delta region of Myanmar has experienced previous cyclones, this was the first time it was of such a magnitude and severity. The local authorities and population need to be more proactive in planning a response programme in such an area. There is a need to change the assessment of needs in such situations from a more reactive one to a more anticipatory approach based on systematic data gathered from the last disaster. For example, after the cyclone in Bangladesh in 1991, local authorities looked into the issue of early warning and shelters. When tested out, only 2 of the 5 shelters were usable due to flooding. Thus there is need to relocate these shelters and make them more accessible at the same time. The local authorities also found that women and children must seek shelter at the first warning and the need to be more precise about the time and place of likely impact as well as the recommended course of action. The local communities must be educated about cyclone preparedness and safety.18The US Secretary of state, Condoleezza Rice stated that the handling of CN should be a matter of humanitarian crisis and not one of politics. This senNow there is technology and expertise to help predict strong storms approaching, the estimated time before they strike, their track and destructibility. This type of information can be freely shared with countries that lack such resources and technology to track climate changes. Bodies such as the Indian Meteorological Department (IMD) (or others) which have the capabilities and resources as well as a location not too distant from Myanmar can share life saving information in a timely fashion. This can assist nations to activate their emergency and disaster response preparedness plans.To further reduce the amount of devastation post disaster, coordinated relief helps to alleviate sufferings. After all we are but ‘one humanity under the same blue sky’. This which appeared to be lacking in Myanmar, may have caused many of the post disaster problems, morbidity and mortality we have seen. The World Food Program has stated that Myanmar has less than 10% of the staff, logistics apparatus and general materials that were needed to manage the crisis.ASEAN (Association of South East Asian Nations) countries responded to CN with a demonstration of regional solidarity through rapid deployment of medical teams from member states, both bilaterally as well as a regional outfit. Once negotiations with Myanmar reached a positive result and teams were allowed entry, no time was wasted. In the midst of the aftermath of CN, ASEAN foreign ministers met in Yangon to discuss regional cooperation and the way forward. There was also an ASEAN Roundtable meeting on 24 June 2008 to renegotiate various issues. It was at these meetings that the Tripartite Core Group (TCG)  was formed. This subsequently facilitated many activities and operations planned. In fact, following the step-down and debrief, the TCG met up and discussed their experiences, crystallizing best practices for possible future regional mission deployments.On the part of Team Singapore, following our busy 9 operational days treating 5,000 patients, we also sent in humanitarian aid, which included food rations, blankets, water purification tablets and hygiene packs. We pledged monetary support in the reconstruction projects and are involved in several rebuilding of school projects in the Delta. In the interim period, we supplied special semi-permanent tentage which could be used as temporary school tents and water pumps. On a more medium term basis, we are involved in water filtration projects with desalination capabilities in the Delta. Singapore is also planning to improve the capabilities of the township hospital in Twante and we hope to assist further with disaster preparedness planning with the local community.Despite the fact that each disaster is different from the previous ones in so many ways, there are always first principles to apply. The response to CN was unique in some ways. In CN, the initial response in the acute phase had to be delayed due to local politics and the execution of work by international humanitarian teams was segmented and segregated to a particular area/township, such that there were no overlaps. The local culture and mindset of the people was also different. During our two week stay, we were given the impression that the locals were very self reliant and resilient. This could have stemmed from the fact that they have always fended for themselves  in whatever simple way they know of and thus had never complained much to local authorities.As humanitarian workers we have to respect local policies and politics and not impose our ideas and practice on others. However, where good and positive influence can be made, changes should certainly be brought about.


Recent years have seen a growing research and policy interest in prevention in many developed countries. However, the actual efforts and resources devoted to prevention appear to have lagged well behind the lip service paid to the topic.We review the evidence on the considerable existing scope for health gains from prevention as well as for greater prevention policy efforts in Germany. We also discuss the barriers to "more and better" prevention and provide modest suggestions about how some of the obstacles could be overcome.In Germany, there are substantial health gains to be reaped from the implementation of evidence-based, cost-effective preventive interventions and policies. Barriers to more prevention include social, historical, political, legal and economic factors. While there is sufficient evidence to scale up prevention efforts in some public health domains in Germany, in general there is a comparative shortage of research on non-clinical preventive interventions. Some of the existing barriers in Germany are at least in principle amenable to change, provided sufficient political will exists. More research on prevention by itself is no panacea, but could help facilitate more policy action. In particular, there is an economic efficiency-based case for public funding and promotion of research on non-clinical preventive interventions, in Germany and beyond, to confront the peculiar challenges that set this research apart from its clinical counterpart. Recent years have seen a growing research and policy interest in primary prevention and health promotion in many European countries and beyond. Some of the interest has been fuelled by the expectation that prevention may mitigate at least a share of the expected, adverse fiscal consequences of demographic changes -3. The eWhile this is a case study on Germany, a low priority on prevention is arguably a rather common phenomenon in many if not all European countries (and beyond). Hence, there is potential Europe-wide relevance in the present article.The rationale behind this stream is that a given situation has to be a) identified as a problem and b) amenable to human control, in order to have a chance at reaching the policy agenda. An assessment of comparative indicators, a chain of events, or other sources of feedback can indicate such an issue and the need of the government for some form of intervention.Assessing the scope for health gains from more and/or "better" prevention in any given country is a challenging task. Here we make use of two (inevitably imperfect) proxy indicators for the extent of "preventive efforts" expended to date in Germany:First, we review Germany's record in terms of two risk factors, alcohol use and smoking, that a) account for a large share of the burden of disease and b) for which there appears to be a widely shared consensus on the set of evidence-based preventive interventions that ought to be pursued ,9. SeconIn comparison with 14 other European countries, Germany shows, with 34% of its population above 15 years smoking on a daily basis, the second highest rate of daily smokers . The daiGermany ranks second among the EU-15 countries in terms of per capita alcohol consumption . The aveThe 2007 European Tobacco Control report confirms a low degree of anti-tobacco policy implementation in Germany . The verWhile some measures have been put in place to curb youth smoking , overall efforts still appear half hearted and of limited success . As of 2A report  comparinfeasibility and acceptability within the population. In light of tight budget constraints, one of the major dimensions of feasibility nowadays is the efficiency  of an intervention. The acceptability of an intervention has to be analysed within the context  of the specific country in question. Therefore, we first scrutinise the cost-effectiveness of proposed solutions and then describe the contextual factors which might be obstacles to health policy change towards prevention.The objective of this stream is to describe the suitability of proposed solutions for a problem in terms of technical Some might argue that part of the reason for the apparently low efforts on prevention in Germany (and elsewhere) might have to do with poor expected 'value for money' to be had from any preventive interventions. Such a view would, however, largely contradict current evidence, which suggests that in particular in the above-mentioned areas there are several highly cost-effective measures that could be implemented, and have been implemented in many other countries. In this section we first briefly review the cost-effectiveness evidence for interventions concerning the prevention of tobacco and alcohol use and subsequently extend the discussion to other areas, allowing us to also highlight the (no doubt existing) limitations in the evidence.There is substantial evidence on cost-effectiveness of policies to prevent and reduce tobacco consumption, even if much of this evidence comes from outside Germany . In partSeveral international systematic reviews have consistently shown alcohol taxation, drunk-driving interventions  as well as regulations to reduce availability of alcohol through minimum legal purchase age to be highly effective in reducing alcohol-related harm. As a further example, brief interventions for drinkers at risk have been shown to be cost-effective ,27. In tThe above interventions only address a share, if a substantial one, of the total preventable disease burden in Germany (and Europe), raising the question how much we know about cost-effectiveness of prevention in other areas. In recent years there has been a growing interest in such research, as documented by a series of major systematic reviews of the international literature -30. Whil(1) Only very few studies assessed non-clinical broader health promotion interventions targeted at obesity, physical inactivity or dietary intake in children or young adults.(2) Interventions targeting children or young people have only very rarely been evaluated in economic terms, despite the high level of expected benefits that are generally attributed to early prevention.(3) The comparability of results between studies is severely limited by the marked differences in the methodologies and definitions applied.From a German perspective, a further limitation is the scarcity of country-specific studies. In the review of Schwappach et al. mentioned above, a mere four studies (out of 195) related to Germany . SimilarWhile evidence is at best one out of many determinants of policy decisions, a more comprehensive evidence base could facilitate decision-making, which at present often follows more intuitive than scientific reasoning: the 2008 report of the compulsory health insurance funds  (one of With seemingly few existing prevention efforts coupled with at least significant evidence on what could be done in the specific areas mentioned (and partly beyond), the question arises of why one observes this contrast. In this section we explore a set of not mutually exclusive hypotheses about obstacles to more and better (primary) prevention in Germany.Part of the explanation for a limited public policy response on prevention may be that the German population simply does not demand such policies as it runs against what some consider a very strong preference for individual freedom and a dislike of government interference in seemingly private business.Interestingly, while such individual preferences are hard to quantify, public opinion surveys tend not to confirm a particularly individualistic preference among the German population. The World Value Survey asks respondents in many countries whether "people should take more responsibility to provide for themselves", or "the government should take more responsibility to ensure that everyone is provided for". Overall, Germany ranks among the European countries with the highest preference for government involvement . There iIn the debate on government's role in prevention, the overarching principle of individual freedom has frequently been invoked as a counter-argument to an augmented public policy stance on prevention, especially in relation to policies that would seek to change people's health-related behaviour. If the above opinion survey results are an accurate representation of the German population's preferences on government intervention in the health behaviour arena, then such counter-arguments would appear unfounded.The introduction of non-smoking regulations in Germany (referred to in more detail below) may further illustrate this debate. Opponents to the regulations warn against what they see as an overly paternalistic approach that is at odds with other "free market" values . HoweverHence, the individualism hypothesis is not really backed up by what the population as a whole feels, as opposed to a group of stakeholders and opinion leaders opposed to more intrusive prevention policies.The question remains, however, how to better align individual preferences and public health goals in general. Research identified the concept of personal risk perception as an important factor for individual behaviour as well as for attitudes towards government intervention ,41. A laAnother potential obstacle to more prevention and health promotion arguably consists in their negative connotation with aspects of public health activities during the Third Reich era (1933-45), often defined by the term "Volksgesundheit" ,48. DuriThe politics stream describes the political context in which health policy is set. Since policy change is dependent on actors working together and reaching compromises, the attitudes and interests of each institution or individual involved needs to be aligned  in order to facilitate change. While some authors commonly use this section to describe changes in political actors over time , we apply this part of the framework to analyse the underlying structure of the German political system that is concerned with health policy. We try to identify whether structural problems in the organisation of legislation, the nature of social health insurance, or the influence of actors from private industry represent obstacles to the formulation and implementation of prevention policies.Germany's public policy in many areas, including healthcare, follows a federal (meaning shared sovereignty) rather than a centralised decision-making process. In particular, each state has the right to implement (or reject) laws on prevention. Taken together, there is a multitude of players, at national and state level, all contributing partially to prevention in Germany. The much-dispersed responsibilities and interests may well hinder the implementation of prevention policies that would otherwise benefit from coordination and harmonisation across regional borders. The recent debate around smoking ban laws is a case in point. In 2007 a national law was enacted banning smoking in public facilities, but the legislation that concerns smoking bans in restaurant and bars was transferred to the state level and resulted in a range of very diverse regulations, some of them complex, based on voluntary efforts with multiple exceptions for small bars, clubs and places holding traditional events . Some inth - December 2nd). The aim of the petition is a unified law for the protection of non-smokers without exceptions. The petition has exceeded the necessary proportion of 10% of eligible voters, so a referendum was scheduled for July 4th 2010 and approved by 61% of the population (voter participation 38%).In response to the built-in exceptions, such as the freedom to run so-called "smoking clubs" to which only registered members have access, a petition for a referendum was initiated in the state of Bavaria , which tend to lack evaluation and/or evidence for effectiveness. In contrast, often programmes are continued, even though proved to be unsuccessful  .In Germany, the Federal Centre for Health Education (BZgA) is a central institution for health promotion and preventive activities. Nevertheless, not all health topics are covered broadly. The BZgA focuses especially on national campaigns on tobacco and alcohol, as well as HIV prevention.Another coordination problem arises through the compulsory health insurance funds, which are at least in principle expected to play a major role in prevention Figure . There aThe overall lack of coordination and responsibility tends to produce a vacuum of interpretation sovereignty on prevention topics. This might be one reason why in Germany industrial lobbyists have a strong influence on legislation and fiscal measures, arguably particularly so in the health field. The severely watered down legislation of the smoking ban in public places may exemplify the influence of the tobacco lobby , as may The case for greater public support for research on prevention, especially of the non-clinical sort, has already been highlighted above. Research on preventive interventions is subject to a market failure: the private actors do not have the incentive to engage in such research, because (a large share of) the resulting insights would become a public good that everybody could use, without having paid the often substantial research costs to arrive at that knowledge. From a sheer economic efficiency  perspective, such knowledge is thus undersupplied compared to the social optimum. Hence, government ought to step in and help promote the production of evidence that the population at large would benefit from, but cannot produce if decisions are left to "the market" alone .The development of a sound scientific basis and structured financial support can improve the impact of healthcare, as appears to have been the case in the German rehabilitation services sector. The establishment of a long-term research programme has improved the recognition and outcomes of rehabilitation services - a traditionally rather neglected area.Prevention research, especially in the non-clinical arena, poses its own challenges, arguably the chief one being the attribution of changes in health outcomes to the intervention examined . Populathttp://www.knp-forschung.de/]. The Federal Centre for Health Education (BZgA) is a partner in this national comprehensive network to strengthen research in primary prevention, with the objective of establishing structures for sustainable primary prevention. Tasks include process definitions, evaluation of combined results and communication to political decision makers, research community and practical institutions. In the intermediation between science and the practical field, the BZgA could play an even greater role.A low public support for non-clinical research is of course not solely a feature of Germany but may well apply globally. This is exemplified by one of the rare attempts to quantify the extent of funding for health research in the UK recently, showing that prevention research accounts for only 2% of the overall research funding on health  . While sIn Germany, substantial health gains could be reaped from the implementation of evidence-based, cost-effective preventive interventions and policies. However, applying the "three-streams" framework proposed by Kingdon , we showoptimal model has yet to emerge. While lack of the perfect model is no excuse for inaction on prevention in Germany, completing the picture of the features of such an ideal model of a national prevention policy should be high on the public health and social science research agenda. For this purpose international cross-country comparative research, rather than a single country case study would seem one promising approach.It is beyond the scope of the present article to exhaustively discuss all the options for a more concerted effort on prevention in Germany. We highlighted only selected key points where improvement seems necessary and feasible. This does not readily provide us with a complete positive model of how prevention as a whole ought to be institutionalised in Germany or any other country. With wide variation in how prevention is delivered and institutionalised across European countries , a singlThe authors declare that they have no competing interests.UW and MS conceived the article and prepared the first draft. Both contributed equally to the paper. MGG helped further revise and finalise the draft. TAB contributed to the production of the first draft and subsequent revisions. All authors contributed to the drafting of the final version. All authors have read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/10/500/prepub


Although there have been reported benefits of health education interventions across various health issues, the key to program effectiveness is participation and retention. Unfortunately, not everyone is willing to participate in health interventions upon invitation. In fact, health education interventions are vulnerable to low participation rates. The objective of this study was to identify design features that may increase participation in health education interventions and evaluation surveys, and to maximize recruitment and retention efforts in a general ambulatory population.A cross-sectional questionnaire was administered to 175 individuals in waiting rooms of two hospitals diagnostic centres in Toronto, Canada. Subjects were asked about their willingness to participate, in principle, and the extent of their participation (frequency and duration) in health education interventions under various settings and in intervention evaluation surveys using various survey methods.The majority of respondents preferred to participate in one 30–60 minutes education intervention session a year, in hospital either with a group or one-on-one with an educator. Also, the majority of respondents preferred to spend 20–30 minutes each time, completing one to two evaluation surveys per year in hospital or by mail.When designing interventions and their evaluation surveys, it is important to consider the preferences for setting, length of participation and survey method of your target population, in order to maximize recruitment and retention efforts. Study respondents preferred short and convenient health education interventions and surveys. Therefore, brevity, convenience and choice appear to be important when designing education interventions and evaluation surveys from the perspective of our target population. Due to the growing availability of medical and health information through various sources and forms of mass media , more anGovernments and health professionals are recognizing this gap in knowledge, and increasing amounts of money and time have consequently been spent on designing and developing health education interventions. Health education interventions usually provide individuals with the necessary knowledge and/or skills regarding the nature of an illness; its mechanism, signs or symptoms; consequences of the illness; prevention, detection techniques or self-monitoring practices; and appropriate self-care, management and treatment methods. For instance, self-management education for chronic illnesses have been developed to empower participants, teach them skills and techniques, and improve their interaction with the healthcare systems to enhance the management of their chronic condition . InterveInterventions are usually evaluated by surveying or interviewing participants. Information such as their experiences, acceptability of the program, and relevant information about individuals before and after the completion of the education sessions are usually collected and analyzed. Evaluation or follow-up surveys provide important data regarding the effectiveness and limitations of the interventions.In addition to the reported benefits of health education interventions across various health issues -10, the The purpose of this study was to identify the preferred design features of health education interventions and intervention evaluation surveys in a general ambulatory population. By determining the extent to which people are willing to participate in education interventions based on various design features, program managers, educators and researchers can develop education initiatives that are more appealing, convenient and accessible to their population of interest, while at the same time increase program participation.Hospital outpatients were recruited during the spring of 2002 to complete a cross-sectional questionnaire while waiting for general diagnostic testing at the University Health Network, a consortium of three hospitals, in Toronto, Ontario, Canada. All participants were able to read and write in English and were willing to provide written informed consent. The institution's research ethics board approved the study.A questionnaire regarding the participation in health education interventions and intervention evaluation surveys was developed. A health education session was defined as an intervention that provides individuals with information about preventative health practices and/or disease self-management care. An evaluation survey was defined as a tool to assess issues related to the program and to one's health, such as physical, emotional or social well-being. The survey instrument was tested with ten outpatients and their family members for clarity and ease of completion prior to the commencement of the study. All individuals waiting in the diagnostic laboratory testing centres were approached by a research assistant and asked to participate in the study. After signing an informed consent, a questionnaire was given to participants to complete on their own.The survey took 10–15 minutes to complete. Participants responded to a set of options concerning their participation in health education interventions and intervention evaluation surveys, in principle  and/or Microsoft Excel Two hundred and three eligible people were approached to participate in the study, of which 175 (response rate 86%) completed the survey. The common reasons for declining to participate in the study were: not feeling well (3%); not having their eye glasses 2%); worry that participating would interfere with their appointment (3%); and refusing to sign the consent form (4%), despite reassurance that their signature would not be linked with their responses  and females, and the mean age was 44.5 (SD 13.8) with a range from 13 to 80 years of age. The majority of participants was born in Canada (66.9%), lived in the Greater Toronto Region (70.1%), primary language was English (92.2%), had some or a college/university degree (57.7%), was employed (67.7%) and had an annual income of or more than $40,000 (73.2%). Overall, 57.4% of our study participants had previously participated in health research, and 77.5% of participants indicated that their self-reported health status to be good to excellent. The characteristics of the study population are presented in Table .5% and f2 = 24.882, p = 0.002, df = 8).In-hospital setting with a group was preferred by most participants, followed by one-on-one with an educator in-hospital, while about half of the respondents  disliked the idea of having an educator coming to their home. If health education intervention sessions were offered once per week over a one-year period, most respondents were willing to participate in only one education session regardless of the setting: 46.1% CI: 38.2, 54.0) for in-hospital with a group, 40.8%  for one-on-one in hospital with an educator, and 25%  for in-home education sessions. As the number of sessions increased in a year, fewer respondents were willing to participate and smaller differences were observed among the three settings .Of the respondents who were willing to participate in education sessions, most people found 30 to 60 minutes per education session acceptable in-hospital setting, where 68.2%  of respondents were willing to spend the noted amount of time in hospital with a group, and two-thirds of respondents  were open to one-on-one with an educator in hospital. Although nearly half of the participants  were reluctant to spend any time in an education session with an educator coming to their home, 39.0% were willing to participate for 30–60 minutes by this format. A small, yet similar proportion of respondents 14%) were willing to spend between 90 and 120 minutes in an education session across all three settings .The two most popular survey methods for evaluating the intervention were by participating in the hospital and by mail, while many were unwilling to complete any surveys at their home with the interviewer , by telephone , or over the Internet  .For the two most popular survey methods, by mail and in hospital, 43.2%  and 39.9%  of respondents, respectively, were willing to spend 20 to 30 minutes filling out an evaluation survey Figure . AlthougGiven that many health education interventions are provided in ambulatory settings, the goal of this study was to inquire about preferences regarding settings, survey methods, duration and frequency for interventions and evaluation survey from an ambulatory-based population. Our study findings suggest that research settings do influence people's willingness to participate in a health education intervention. Most individuals are willing to participate in only one education session per year for 30 to 60 minutes, preferably in hospitals, either in a group or one-on-one format. In addition to already being at the hospital for other reasons, hospital settings may be more comforting to individuals due to the presence of other people, or they may feel that hospital settings legitimize the proposed intervention or survey . In factThe majority of respondents are not willing to participate in education sessions in their home, which showed a different pattern from the responses towards in-hospital settings, possibly because this format may represent an invasion of their privacy and security. Certain individuals may also be discouraged from participating in home interviews due to fear of strangers, violence or abuse . HoweverThe type of survey methods used also influence how often and how long respondents are willing to spend completing an evaluation survey. In general, most people are willing to spend 20 to 30 minutes completing one to two surveys in hospital or by mail, but lower enthusiasm was observed for in-home or telephone methods. Surveys at hospitals can be completed while waiting for a medical appointment or immediately after the intervention, and mail surveys may be more popular because they allow participants to complete the survey at their convenience. Reasons for lower willingness to complete in-home surveys may be similar to those previously noted for in-home education sessions. Since telephone surveys usually require immediate completion, devoting a continuous period of time may be tiresome to some unless one is very motivated.The preference to participate in studies by mail, as opposed to at home with an interviewer or by telephone, is problematic for program managers and researchers because mail surveys tend to have low response rates . In addiCurrently, the Internet is not universally accessible and not all users are proficient at it , which mDue to the overall shortage of information regarding whether questionnaire length affects the response rate, this factor is still being debated among the academic literature. Some studies show that the response rate and the number of missing responses in a questionnaire are not related to questionnaire length, provided the questionnaire is well designed and easy to complete ,31,44. OThere are a few limitations associated with this study. Firstly, our study participants were recruited from hospital diagnostic testing centres and may not represent the general population. Our study participants may frequent the hospital more often than the general population, particularly since the majority of participants favoured a hospital-based setting for both the intervention and the evaluation survey. These findings may also imply a potential selection bias given the study population and setting were ambulatory-based. Nevertheless, this was our targeted population and the goal of this study was to identify their preferences. Furthermore, a normal distribution was observed among participants' self-reported health status, where 77 percent reported being in good to excellent condition, which is similar to the self-reported health status distribution observed among the general populations of Canadians, where 66 percent reported being in very good to excellent condition . Our samOur findings have important implications for the design and evaluation of education interventions. Our participants strongly preferred to receive educational interventions in a hospital setting either within a group or one-on-one with an educator. This was somewhat of a surprise at a time where the emphasis of healthcare is shifting towards a more home-based environment. This lack of interest in home-based interventions is also apparent in home-based survey evaluations. A small percentage of participants were interested in telephone or internet-based surveys and even fewer wanted interviewers coming into their homes.In terms of duration and frequency for both health interventions and their evaluation, participants preferred short and convenient education sessions and evaluation surveys. Education interventions should not be too time intensive that people cannot fit them into their daily schedules. Therefore, balance is needed between the length of time necessary to deliver essential information and/or facilitation of new skills and the convenience and brevity participants desire to better design effective health education interventions. Furthermore, providing individuals with choice in regard to location and modalities may maximize recruitment and retention efforts. By considering potential participants' preferences in the design and implementation of health education interventions, it may be possible to improve recruitment efforts and increase participation rates.The author(s) declare that they have no competing interests.EG was involved in the conception and design of the research idea, coordinated the acquisition of the data, analyzed and interpreted the data, and drafted, reviewed and revised the manuscript. CDL analyzed and interpreted the data, draft, reviewed and revised the manuscript. AP was involved with the conception and design of the research idea, acquisition of the data, analyzed and interpreted the data, and drafted and reviewed the final manuscript. JC was involved with the conception and design of the research idea, coordinated the acquisition of the data, provided guidance with the analyses and interpretation of the data, and reviewed the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:Frequency table for the number of minutes respondents are willing to spend in a health education session by setting. The data provided present the frequency of respondents' choice of the 5 number of minutes they are willing to spend in a health education session by setting.Click here for file


New products evolving from research and development can only be translated to medical practice on a large scale if they are reimbursed by third-party payers. Yet the decision processes regarding reimbursement are highly complex and internationally heterogeneous. This study develops a process-oriented framework for monitoring these so-called fourth hurdle procedures in the context of product development from bench to bedside. The framework is suitable both for new drugs and other medical technologies.The study is based on expert interviews and literature searches, as well as an analysis of 47 websites of coverage decision-makers in England, Germany and the USA.Eight key steps for monitoring fourth hurdle procedures from a company perspective were determined: entering the scope of a healthcare payer; trigger of decision process; assessment; appraisal; setting level of reimbursement; establishing rules for service provision; formal and informal participation; and publication of the decision and supplementary information. Details are given for the English National Institute for Health and Clinical Excellence, the German Federal Joint Committee, Medicare's National and Local Coverage Determinations, and for Blue Cross Blue Shield companies.Coverage determination decisions for new procedures tend to be less formalized than for novel drugs. The analysis of coverage procedures and requirements shows that the proof of patient benefit is essential. Cost-effectiveness is likely to gain importance in future. There is a gap between scientific knowledge and daily medical practice. While there have been major scientific breakthroughs, e.g. in the field of genomics or stem cell research, this does not necessarily directly translate into a variety of new treatments available to patients. A term frequently used to describe approaches for bridging this gap is "translational medicine". Translational medicine faces two major obstacles: the first is the translation of basic science discoveries into clinical studies; the second is to translate clinical studies into medical practice . A largeCoverage determination may prove to be a hurdle as difficult as those encountered in demonstrating the product's efficacy, safety and quality. Due to rapidly increasing healthcare expenditures, numerous countries currently set up institutions that further evaluate new medical technologies after their market approval, before national health services or insurance systems provide coverage . The so-Looking closely at procedures for coverage determination may demand more attention than a time-constraint clinician or manager can give – the fourth hurdle is highly heterogeneous and subject to frequent reform. Earlier studies have approached the fourth hurdle from a legal or institutional perspective ,6. Yet tThis study develops a process-oriented framework to describe fourth hurdle procedures from the perspective of a life sciences company. The framework fits into value-chain representations of technology development and allows for easy presentation and monitoring of these decision procedures. Guidance is derived on how to prepare in advance for the later stages of translational medicine.The study is based on expert interviews, as well as a literature search in PubMed, CRD, Econlit and generally via Google. Relevant attributes of coverage decision-making procedures were extracted and consolidated to a limited number of categories, to fulfil the following, conflicting targets to the highest possible degree:• Small number, to be manageable• Conclusive, to describe all items relevant to a life sciences company• Universal, to facilitate an international comparison of procedures• Accessible, to enable an investigation of these items for a potential market.The framework was developed as part of a research project on coverage of novel tissue-engineering (TE) treatments which investigated coverage and reimbursement processes for Autologous Chondrocyte Implantation (ACI) -9. ACI iIn order to cover various aspects of reimbursement decisions for different types of healthcare funding, institutions in England (tax-based), Germany  and the USA  were chosen. These countries are of outstanding importance to innovative life sciences companies due to their large healthcare expenses. Decisions by the following institutions were selected for comparison: for the English National Health Service, the National Institute for Health and Clinical Excellence (NICE) was selected as the NICE appraisals are relevant for the entire English population and NICE serves as an international reference for fourth hurdle institutions . For GerThe selected institutions are highly relevant to life sciences companies due to the healthcare budget within the scope of their decisions. They additionally represent very different approaches to coverage determination. For this reason, it is important to understand the coverage procedures of these institutions before proceeding to a wider international comparison.Institutions for coverage determination are frequently subject to tight regulation and supervision by government and social courts. This analysis is dedicated to decision-making procedures within the institutions; the legal basis and decisions shaping these institutions were excluded from this analysis. Fourth hurdle procedures are indirectly affected by the rigour of licensing decisions which can vary by type of technology and by jurisdiction. Due to its focus on reimbursement decision making, also the procedures of market approval are beyond the scope of this study.Reimbursement is both highly heterogeneous across countries and quickly developing at the same time. Figure These decisions about coverage, reimbursement and care management will then have a strong impact on the technology's use in health care. Information derived from this use may provide feedback to the different stages of this development: off-label use by doctors may provide information for product development on new target markets ; post-apIn the course of the product's life cycle, the decisions involved with proceeding become increasingly heterogeneous: while for many products, market authorization is granted on a supra-national or at least a national level, there are usually several healthcare payers per country. Within the organization of one payer, there can be more than one decision process; e.g. if decisions about new drugs differ from decisions about other technologies or if a formal process is only triggered in case of high budget impact. The heterogeneity further increases over the course of technology diffusion – eventually, decisions of adopting the new technology are made on the level of single healthcare providers or even single doctors. This increasing heterogeneity of decisions is shown in Figure For an overview of procedures for coverage decision-making in the case of technologies like ACI, see Table Besides out-of-pocket payments, healthcare financing can for example be provided by national and local health services, statutory social insurance systems, private insurance companies, employer-based insurance or integrated service delivery systems with insurance function . The relTo arrive at an estimate of the relevance of a product's market size covered by the healthcare payer, the number of covered individuals and the types of reimbursed services are of interest to a company. As an example, the German statutory health insurance covers about 90% of the German population. In 2007, its total expenses for health services amounted to £144 billion . While tTo be able to tailor its product to the purchaser's preferences, it is relevant for a life sciences company to know who is going to make the decision to finance its product. Coverage decisions are frequently associated with national institutions under the spotlights of politics and the media. Yet due to limited capacities of reviewing bodies, only a small portion of novel technologies is subjected to the resource-consuming formal procedures of national bodies. The vast majority of decisions are usually made at the meso-level of regions or healthcare organizations such as primary care trusts in England or providers' "local coverage determinations" for Medicare in the US. Usually, decisions at the meso-level are far less formalized and thus less suitable for systematic analysis of published documents .Knowing the trigger for a decision-maker's formal evaluation process is, therefore, relevant to determine whether a decision-maker's formal criteria can be expected to be applied at all. Various systems for prioritizing technologies for further investigation can be found across decision makers. Criteria that new technologies have to fulfil to become subject of a formal appraisal process include high-budget impact or disagreement on the technology's effectiveness . In the For Germany, primarily the procedure of initiating an appraisal is made explicit: the committee's directives on evaluating technologies only determine the parties authorized to initiate an assessment . AmbulatCoverage decisions require medical, economic and legal expertise. Thus, they are usually made by interdisciplinary committees. For the German statutory health insurance, decisions are made on behalf of both the Federal Associations of Sickness Fund Physicians or the German Hospital Association and the Federal Associations of Sickness Funds by the G-BA . For theTypically, new technologies undergo some form of assessment of patient benefit or cost-effectiveness prior to the decision. These assessments frequently differ from those used for market approval . In the How patient benefit should be established is ambiguous and a topic of persistent controversy, particularly with regard to the use of surrogate endpoints in health-impact measurement and the appropriateness of measurement tools for health-related quality of life . AnotherEconomic evaluations add the issue of value for money and include the costs of a treatment, which implies the assessment of the cost of the respective treatment strategy as a whole, not only the product price. Depending on the type of outcome compared with the costs, different types of studies can be distinguished: cost-benefit analyses measure benefit in terms of willingness to pay; cost-utility analysis use utility values represented by quality-adjusted life years; and cost-effectiveness analyses compare the additional costs associated with a new treatment with the additional health benefit in terms of clinical endpoints ,33. A vaNICE, for example, uses cost-utility models as the state of the art to obtain data for a health technology's effectiveness and cost-effectiveness. Independent academic centres are commissioned to review the published evidence on the technology and synthesize this evidence in decision-analytic models.The G-BA can commission technology assessments to the Institute for Quality and Efficiency in Health Care . This institute also is involved in the development of methods for the evaluation. IQWiG holds a critical attitude towards the use of models and rejected the use of quality-adjusted life years in its statement of methods published in December 2006 . In its For companies in the Blue Cross and Blue Shield Association, the Technology Evaluation Center (TEC) is an important source of health technology assessment methods and reports. The use of formal cost-effectiveness analyses has been advocated in the USA  and stanThese assessments feed into an appraisal of the new technology which may to a large extent be determined by social legislation. For example, according to Book Five of the German Social Code, the G-BA is to appraise whether technologies are "expedient, necessary and efficient" . On behaIn the case of ACI, the decisions differed across deciding bodies. For example, the G-BA did not reject in-patient treatment with ACI in knee joints so that it is covered by the statutory health insurance . NICE reMarket access in terms of coverage may not be sufficient to allow for appropriate funding of a novel healthcare technology. The determination of the level of funding provided by third-party payers is frequently a distinct step, which may involve different decision-making bodies. In some cases , the price requested by the manufacturer is reimbursed directly. Alternatively, insurers may enter into price negotiations with manufacturers as occurs for new drugs in the USA. Besides the amount reimbursed, technical requirements for reimbursement need to be established, e.g. new codes for procedures in fee schedules .Reimbursement can take the form of global budgets, salaries, capitation, case-based payments, fee-for-service or mixed schedules . It has In a hospital setting, where products like ACI are typically applied, reimbursement is usually in diagnosis-related groups (DRGs) . These gReimbursement mechanisms can be explicitly designed to accelerate or block the adoption of certain new and more expensive technologies. An example for drug reimbursement provides reimbursement of reference prices instead of manufacturer prices . ExampleReimbursement of a new healthcare technology may come along with specified rules for service provision or quality controls. In general, approaches to connect financing of healthcare to service provision have been termed "managed care" . ExampleManaged care has played a particularly important role in the USA: most payers offer managed care products. Nevertheless, the number of fully integrated HMO plans has decreased considerably since the end of the nineties ; insuranCoverage of new technologies can also be linked with requirements for collecting further data on the technology's effectiveness or cost-effectiveness. This so-called "coverage with evidence development" (CED) balances the aim of offering patients promising new health technologies with the demands for prudent use of resources and the principled arguments that coverage should be based on solid evidence of clinical effectiveness ,20. ValuReimbursement decisions are made in the context of a variety of stakeholders' interests . BesidesThe decision-making process by NICE is exceptional in terms of stakeholder participation: a manufacturer is offered the status of formal consultee in the appraisal process. This implies that he/she can participate in the "scoping" of the assessment, comment on various documents, submit a report on clinical and cost-effectiveness and appeal against the final appraisal. In decisions by the German G-BA, stakeholder participation beyond doctors and statutory health insurance funds is mainly reduced to comments from medical experts, self-help groups and patient organizations, as well as from umbrella associations of manufacturers.Usually, national bodies publish decision memorandums on websites or in official government documents. In the case of national decisions, published material can go far beyond the decisions themselves. Frequently, decision bodies are additionally obliged to meet standards of procedural transparency and to publish themes of future consultations or documents from ongoing processes. Information on decisions and their rationale is less accessible for decisions at the micro- or meso-level. As far as they are available, these publications provide valuable information for companies both on how to learn best to fulfil requirements for reimbursement and how to keep trace of their competitors..The English NICE has high standards regarding transparency in decision-making: not only the appraisals and the evidence they are based on, but also a number of documents in the decision-making process are published online. The German G-BA publishes their decisions and the related health technology assessment reports on their website [see e.g. ]. The CeTable This study presents a simple framework for monitoring fourth hurdle procedures, which consists of eight key steps. Compared with alternative approaches, this framework allows for easy monitoring of these key steps in the process of coverage determination and for easy communication to decision-makers in research and development.It additionally allows for a comparison of very different processes, e.g. those in English primary care trusts. Even though the majority of coverage decisions are made at this sub-national level, these processes are frequently ignored by the literature.The framework is best suited to describe formal stages of coverage decisions, based on published documents. Yet usually, health policy decisions are subject to diverse and potentially conflicting political interests ,24,60,62While, on the one hand, the framework is primarily for a descriptive analysis of fourth hurdle procedures, it can also serve as a starting point for normative analysis. Daniels and Sabin propose four criteria for coverage decision procedures in order to meet the standard of "accountability for reasonableness" : (1) DecThe coverage decisions for the reference case study are heterogeneous: Coverage is provided by the German statutory health insurance for hospital care and by a number of private payers in the USA if certain criteria are met. Coverage was declined by NICE (yet the development of further evidence is supported), as well as by the one Medicare local coverage determination.One major reason for this heterogeneity may be the ambiguous evidence both for the effectiveness and cost-effectiveness of ACI: there are studies that suggest ACI is effective, but the long-term effectiveness and cost-effectiveness remain to be established . The difInterestingly, the German G-BA arrived at different conclusions for different conditions: while coverage for ACI in finger and shoulder joints was denied, the coverage decision for ACI in knee joints was postponed until 2014, with no conclusive evidence of long-term effectiveness for either condition. The explanatory statement justified this decision according to anticipated new evidence, particularly from studies in England. This can be taken as an example of the substantial amount of unexplained variance in coverage decisions, yet may also partially be explained by cooperation among coverage decision-makers; apparently, the G-BA is waiting for the results of further clinical studies conducted on behalf of NICE.To pave the way for a research project from bench to bedside, project managers should prepare for the stages through which a novel technology will have to pass before being applied in healthcare. This framework provides background information and can help identifying important issues to address. These include, for example, which decision procedure is likely to be triggered by the product. If formal decisions on a macro-level are likely, clinical trials should be designed to include the endpoints and potentially the treatment alternatives requested by the relevant fourth hurdle processes.The level of detail in which these questions can be answered will depend on the stage of project development . Early iAny overview of coverage decisions can only be a snap-shot, as institutions and requirements for coverage of new medical technologies are subject to frequent, considerable changes. This is illustrated by recent reforms in all countries included in this review, e.g. the introduction of formal cost-effectiveness analysis for novel drugs in Germany which was passed in parliament in February 2007. In June 2008, the methods of cost-effectiveness analysis were still subject to debate . TherefoThe US healthcare system is highly heterogeneous and hosts a multitude of payers, many of which have different processes and requirements. Even though the case study presented above investigated major players, findings can hardly be generalized.Besides the processes described in Table The EMEA and the FDA have different practices for licensing ,70, and In general, the procedures involved in the translation of clinical research from bench to bedside are internationally very heterogeneous and complex. Therefore, any simple framework can be claimed to lead to over-simplification and there are research questions for which the framework is not the best choice. For a detailed institutional analysis of coverage decision-makers, the framework developed by Hutton and colleagues would be better recommended because it can provide more precise answers . The fraThe diffusion of health technology is a dynamic process between patients, physicians, hospitals, healthcare systems and technology. Apart from a product's effectiveness or cost-effectiveness, important impact factors in this process include purchasing power in the target country  or commeAll over the world coverage decision-makers are developing procedures to prioritize healthcare spending. Project managers involved in the translation of research projects from bench to bedside should keep track of the relevant fourth hurdle procedures in their target countries as part of their marketing activities. The framework presented above provides a tool to describe and compare these procedures in a transparent and manageable manner.The focus of a decision-maker's interest is the evidence-based establishment of a technology's effectiveness in terms of patient-relevant endpoints. Of the three countries under investigation in the case study, the use of formal cost-effectiveness analysis was to a large extent restricted to NICE in England – yet due to increasing need for prioritization as a result of escalating healthcare costs, the high international perception of NICE and the evolving use of formal cost-effectiveness analysis for drug treatments ,11,39,75Life sciences companies should include final health outcomes in their clinical trials for market approval, to provide information on patient benefit in order to achieve coverage. They should additionally collect resource consumption data, so that they can provide health economic evidence if required.As shown in Figure It has been reported that the criteria for establishment of effectiveness and value for money are not always applied consistently ,76: deciTo enhance the translation of research findings, it would be desirable if institutions for research funding would increase awareness of later stages in the project development process. This could be conducted, for example, if as a part of advertisements for research opportunities, information on targeted markets and potential reimbursement strategies was requested.There are a variety of open research questions on the different process steps. The framework presented here can assist researchers in identifying and distinguishing different areas of research at the important intersection of translational medicine and health services research. Two major areas of further research on the whole process of translation should be addressed: first, fourth hurdle institutions have been subject to continual reform. Thus, the framework presented above should be applied on a regular basis to keep track of changing conditions of market entry and diffusion. The framework was applied only to one technology and a limited number of decision-makers in three countries. It would, therefore, be of additional interest to include further decision-makers and reference technologies in future analysis. Second, coverage is a crucial target for the marketing activities of life sciences companies. It would be of value to develop further guidance on how requirements for coverage can be integrated into innovation management in a more systematic manner. Given the escalating healthcare costs in industrialized countries and the rising importance of fourth hurdle procedures to prioritize healthcare resources , it can This research was carried out on behalf of the Helmholtz Zentrum München, German Research Center for Environmental Health (HMGU) and was partly funded by the German Federal Ministry of Education and Research. The HMGU is an independent organization funded by the German and Bavarian government. During the time of this study, all authors were employees of the HMGU and neither did nor do not have a conflict of interest with regard to this project.WR conducted the searches for Germany and the UK, developed the framework and wrote the manuscript. SH conducted the searches on the fourth hurdle in the USA and helped to draft the manuscript. JJ was involved in all stages of the project and provided substantial input on the framework, the sources and validity of the data used and the conception of the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here: