http://repub.eur.nl/res/aut/13612/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/39610/ 2013-01-01T00:00:00Z This article's aim is to understand if and how the efforts to accumulate and organize clinical data transformed the regulation of pharmaceutical care. The authors analyze how the employment of databases by collectives of physicians and researchers shape both clinical and policy practice-and thereby reshape the relation between clinical work and policy. Since the late 1990s, Dutch government has supported the development of clinical databases for specific expensive medicines to gain oversight about actual medicine use. To be able to produce evidence for appropriate medicine use, the collectives set regulations in clinical practice. These internal regulations provide a framework for establishing "appropriate medicine use", steering reimbursement decisions. However, internal regulation and policy rules differ in how quickly they can change. While the employment of databases in clinical practices results in a constant adjustment of the protocols, policy makers require the databases to provide for static moments of "proven appropriate medicine use" in order to account for and define a fixed and closed formulary. Subsequently, the employment of the databases did not deliver on the promise of oversight and control due to different clinical and policy requirements. Nevertheless, the databases did stimulate appropriate medicine use and reimbursement in clinical practice. http://repub.eur.nl/res/pub/38138/ 2012-10-05T00:00:00Z Medical doctors in teaching hospitals aim to serve the two central goals of patient care and medical training. Whereas patient care asks for experience, expertise and close supervision, medical training requires space to practise and the 'invisibility' of medical residents. Yet current reforms in postgraduate medical training point to an increasing emphasis on the measurable visibility of residents. Drawing on an ethnographic study of gynaecology training in The Netherlands, this article demonstrates that in daily clinical routines multiple practices of residents' visibility (visibilities) coexist. The article lists four visibilities: staging residents, negotiating supervision, playing the invisibility game and filming surgical operations. The article shows how attending physicians and medical residents tinker with these visibilities in daily clinical work to provide good care while enacting learning space, highlighting the increasing importance of visualising technologies in clinical work. Moreover, the article contributes to traditional sociological accounts on medical education, shifting the focus from medical education as a social institution to the practices of medical training itself. Such a focus on practice helps to gain an understanding of how the current reform challenges clinicians' educational activities. http://repub.eur.nl/res/pub/34701/ 2012-06-01T00:00:00Z In this paper we argue that performance measurement can be done better by general, less accurate measurements than by complex - and possible more accurate - ones. The conclusions of this study are drawn from a case study of the Dutch Foundation for Effective Use of Medication. While most studies about performance measurements focus on the management of public service organizations, this case study - informed by the literature from Science and Technology Studies - focuses on the active role of the measurements themselves. In the paper we show that indicators do not have to be as complex as the practices they represent - as long as they are part of a chain of intermediary data that allow travelling from the general or simple indicators to detailed data in day-to-day practices and vice versa. Furthermore, general indicators enable stakeholders to obtain distance from each other. Rather than the involvement of stakeholders, it is this reflexive distancing that explains the degree of compliance to performance measurement and thereby the prospect for effective co-governance. http://repub.eur.nl/res/pub/21494/ 2010-11-11T00:00:00Z Abstract In prevention and health promotion interventions, screening methods and risk profile assessments are often used as tools for establishing the interventions' effectiveness, for the selection and determination of the health status of participants. The role these instruments fulfil in the creation of effectiveness and the effects these instruments have themselves remain unexplored. In this paper, we have analysed the role screening methods and risk profile assessments fulfil as part of prevention and health promotion programmes in the selection, enrolment and participation of participants. Our analysis showed, that screening methods and health risk assessments create effects as they objectify health risks and/or the health status of individuals, i.e., they select the individuals 'at risk' and indicate the lifestyle modifications these people are required to make in order to improve their health. Yet, these instruments also reduce the group of participants thereby decreasing the possible effect of interventions, as they provide the legitimisation for people to make choices to whether they enrol or not and what lifestyle changes they incorporate into their lives. In other words, they present a space of interaction, in which agency is distributed across the practice nurses, the participants and the instruments. Decisions were not just made upon the projection of the outcomes of these instruments; decisions that were made by both the patients and practice nurses were the resultant of their opinions on these outcomes that were formed in interaction with the instruments. http://repub.eur.nl/res/pub/21611/ 2010-11-07T00:00:00Z In this paper we argue that performance measurement can better be done by general, less accurate measurements than by complex – and possible more accurate - ones. The conclusions of this study are drawn from a case study of the Dutch Foundation for effective use of medication. While most studies about performance measurements focus on the management of public service organizations, this case study - informed by the literature from Science and Technology Studies – focuses on the active role of the measurements themselves. Indicators, we show, do not have to be as complex as the practices they represent, as long as they are part of a chain of intermediary data that allow traveling from the general or simple indicators to detailed data in day-to-day practices and vice versa. Furthermore, general indicators enable stakeholders to take distance from each other. Rather than the involvement of stakeholders, it is this reflexive distancing that explains the degree of compliance to performance measurement and thereby the prospect for effective co-governance. http://repub.eur.nl/res/pub/23156/ 2010-06-01T00:00:00Z Abstract. PURPOSE: Postgraduate medical training was reformed to be more responsive to changing societal needs. In the Netherlands, as in various other Western countries, a competency-based curriculum was introduced reflecting the clinical and nonclinical roles a modern doctor should fulfill. It is still unclear, however, what this modernization process exactly comprises and what its consequences might be for clinical practice and medical work. METHOD: The authors conducted a Q methodological study to investigate which different perspectives exist on the modernization of postgraduate medical training among actors involved. RESULTS: The authors found four distinct perspectives, reflecting the different features of medical training. The accountability perspective stresses the importance of formal regulations within medical training and the monitoring of results in order to be more transparent and accountable to society. According to the educational perspective, medical training should be more formalized and directed at the educational process. The work-life balance perspective stresses the balance between a working life and a private life, as well as the changing professional relationship between staff members and residents. The trust-based perspective reflects the classic view of medical training in which role modeling and trust are considered most important. CONCLUSIONS: The four perspectives on the modernization of postgraduate medical training show that various aspects of the modernization process are valued differently by stakeholders, highlighting important sources of agreement and disagreement between them. An important source of disagreement is diverging expectations of the role of physicians in modern medical practice. http://repub.eur.nl/res/pub/19496/ 2010-02-19T00:00:00Z Objectives: To assess the effects of a CPOE system on inter-professional workflow in the medication process. Methods: Twenty-three semi-structured interviews with physicians, nurses, and pharmacists were conducted in a Dutch academic hospital. In addition, the handwritten and system- generated documents used daily were collected for analysis. Data was analyzed on the basis of three conceptual themes in the inter-professional workflow: division of tasks, flow of information, and task coordination. Results: The CPOE system reorganized the existing work procedures, affecting the workflow among the three professional groups both advantageously and disadvantageously. The system resulted in the reassignment of tasks and reallocation of areas of expertise in the medication process. Moreover, patients' medication-related information became fragmented in both the paper records and in the electronic records, as well as in different professional domains. The system provided lim ited support for professional groups to coordinate their tasks temporally. It also made it difficult to build mutual intelligibility upon new changes in the medication plan. To integrate tasks, the professional groups had to bypass the system or add new steps and extra coordinative tasks. Conclusion: We identified several workflow integration issues after the implementation of a CPOE system. Our insights into these issues can help ensure that the system design or redesign properly integrates all tasks, information, and areas of expertise of professional groups into those of the physicians. http://repub.eur.nl/res/pub/20174/ 2009-12-01T00:00:00Z http://repub.eur.nl/res/pub/20168/ 2009-11-01T00:00:00Z De onderzoeksvraag Van gezondheidszorginstellingen wordt verwacht dat zij investeren in de veiligheid van de door hen geleverde zorg (Meurs 2008). Burgers – als zij onverhoopt patiënt en/of cliënt worden van een zorginstelling – moeten er op kunnen vertrouwen dat de kwaliteit van de zorg goed is en dat er veilig wordt gewerkt. Terwijl de professionals voor goede kwaliteit zorgen, zijn managers, bestuurders en toezichthouders verantwoordelijk voor de randvoorwaarden opdat goede kwaliteit ook geleverd kan worden. Tronto maakt in dit verband het onderscheid tussen zorgen dat en zorgen voor. Managers en bestuurders zijn verantwoordelijk voor het realiseren van de randvoorwaarden die professionals nodig hebben om goede kwaliteit en veiligheid te leveren (Tronto 1994). Toezichthouders zien hierop toe. Professionals zorgen voor de feitelijke kwaliteit en veiligheid van patiëntenzorg in het dagelijks handelen en hebben ook een verantwoordelijkheid om zich te verantwoorden over de wijze waarop zij kwaliteit en veiligheid waarborgen. In nationale kwaliteitsprogramma's zoals Sneller Beter 3 en Zorg voor Beter zijn veel initiatieven genomen om de zorg veiliger te maken. Deze initiatieven hebben laten zien dat de zorg veiliger kan, maar vooral ook dat veilige zorg niet duurder of in andere zin minder efficiënt hoeft te zijn. Veiligheid wordt dan ook meer en meer gezien als een strategische doelstelling die in het verlengde ligt van andere strategische doelstellingen van zorginstellingen. http://repub.eur.nl/res/pub/21907/ 2009-11-01T00:00:00Z ABSTRACT Background: Policy instruments based on the working of markets have been introduced to empower consumers of healthcare, however it is not easy to become a critical consumer in healthcare. Objectives: The aim of this study is to analyze the possibilities of the state to strengthen the influence of patients with the aid of a new financial regime, such as personal health budgets. Methods: Data were collected through in-depth interviews with executives, managers, professionals and client representatives of six long-term care institutions. Results: Introducing individual budgets implies that the responsibility for budgetary control is shifted from the organizational level to the individual level of the caregiver-client relation. Offering more luxurious care necessitates a stronger demarcation of standard care because organizations cannot simultaneously offer extra care part of regularly care. Hence, new financial instruments influence the culture of care receiving and giving. Distributive justice takes on new meaning with the introduction of financial market mechanisms in healthcare; the distributing principle of ‘need’ is transformed into the principle of ‘economic demand’. Conclusion: Financial instruments acted not only as a countervailing power against that are not client-oriented enough, but were also used by providers to reinforce their own position vis-à-vis demanding clients. Tailor-made finance is not the same as tailor-made care. http://repub.eur.nl/res/pub/19467/ 2009-02-01T00:00:00Z In many countries of the Western world, the role of health technology assessment (HTA) in funding decisions of medical technologies is increasing. HTAs are expected to support decision-makers in delineating the collectively funded benefits package. To maximize their potential, it is essential that assessments are valid, reliable and timely, and that it is transparent how information provided in assessments is used in decision-making. Against this background, this article aims to review the current state of affairs regarding the use of HTA in the area of medical specialist care in The Netherlands and to evaluate strengths and weaknesses of the HTA-based system for priority setting. The reason to do so was the introduction of a new hospital financing system in The Netherlands, which allowed for expansion of the HTA system that already existed for pharmaceuticals to medical specialist care. A comprehensive account of the HTA system for medical specialist care was created using the so-called Hutton framework, followed by an exploration of its strengths and weaknesses. An important lesson to be learned from the early Dutch experiences with HTA in the area of medical specialist care is that the nature and complexity of health technologies in this area create practical problems regarding the amount and quality of available data needed to make the HTA-based system work. This hampers an unambiguous interpretation of assessment data and thus calls for stronger requirements regarding transparency and stakeholder participation. Future work focusing on the role of HTA in funding decisions is needed to provide insights in best practices for HTA systems in circumstances where a delicate balance needs to be achieved between promoting innovation, supporting effective and timely decision-making and preventing the coverage of technologies that represent a waste of resources. http://repub.eur.nl/res/pub/19403/ 2009-01-01T00:00:00Z OBJECTIVES: Research has shown that effectiveness, cost-effectiveness, and severity of illness each play a role in drug reimbursement decisions. However, the role of budget impact in such decisions is less obvious. Policy makers almost always demand a budget impact estimate yet seem reluctant to formally include budget impact as a rationing criterion. Health economists even reject budget impact as a legitimate criterion. For these reasons, it is important to examine its use in rationing decisions, and rationales underlying its use. METHODS: We trace several rationales supporting the use of budget impact through a literature review, supplemented by semistructured interviews with eleven key stakeholders involved in drug reimbursement decisions in the Netherlands. RESULTS: Budget impact arguments are used in certain instances, although policy makers appear uncomfortable with its use because well described rationales still are lacking. In addition, we identify the following rationales to support budget impact as a rationing criterion: opportunity costs, loss aversion, uncertainty and equal opportunity. CONCLUSIONS: Budget impact plays a role in drug reimbursement decisions and has rationales to support its use. However, policy makers do not easily admit that they consider budget impact and are even reluctant to explicitly use budget impact as a formal criterion. A debate would strengthen the theoretical foundation of budget impact as a legitimate criterion in the context of drug reimbursement decisions. Such discussion of budget impact's role will also enhance policy-makers' accountability. http://repub.eur.nl/res/pub/19404/ 2009-01-01T00:00:00Z BACKGROUND: In recent years, a trend in the use of tailor-made approaches and pragmatic trial methodology for evaluating effectiveness has been visible in programs ranging from large-scale national health prevention campaigns to community-based initiatives. Qualitative research is used more often for tailoring interventions towards communities and/or local care practices. This article systematically reviews the contribution of qualitative research in developing tailor-made community-based interventions in primary care evaluated by means of the pragmatic trial methodology. METHODS: A systematic search of Pubmed/Medline and Embase revealed 33 articles. Using a literature mapping process, the articles were arranged according to the development phases identified in the MRC framework for the development of complex interventions to improve health. RESULTS: The review showed qualitative research is mainly used to provide insight into the contextual circumstances of the interventions' implementation, delivery and evaluation. To a lesser extent, qualitative research findings are used for tailoring and improving the design of the interventions for a better fit with daily primary care practice. Moreover, most qualitative findings are used for tailoring the interventions' contextual circumstances so that the interventions are performed in practice as planned, rather than adjusted to local circumstances. CONCLUSIONS: Pragmatic trials seem to be oxymoronic. Although the pragmatic trial methodology establishes the effectiveness of interventions under natural, non-experimental conditions, no pragmatic fit is allowed. Qualitative research's contribution to the development of tailor-made community-based interventions lies in providing ongoing evaluations of the dilemmas faced in pragmatic trials and allowing for the development of true tailor-made interventions http://repub.eur.nl/res/pub/16483/ 2008-12-01T00:00:00Z Background. Information systems can play a key role in care innovations including task redesign and shared care. Many demonstration projects have presented evidence of clinical and cost effectiveness and high levels of patient satisfaction. Yet these same projects often fail to become part of everyday clinical routines. The aim of the paper is to gain insight into a common paradox that a technology can meet the criteria for success set out at the start of the project yet fail to become part of everyday clinical routines. Methods. We evaluated a telecare service set up to reduce the workload of ophthalmologists. In this project, optometrists in 10 optical shops made digital images to detect patients with glaucoma which were further assessed by trained technicians in the hospital. Over a period of three years, we conducted interviews with the project team and the users about the workability of the system and its integration in practice. Beside the interviews, we analyzed record data to measure the quality of the images. We compared the qualitative accounts with these measurements. Results. According to our measurements, the quality of the images was at least satisfactory in 90% of the cases, i.e. the images could be used to screen the patients - reducing the workload of the ophthalmologist considerably. However, both the ophthalmologist and the optometrists became increasingly dissatisfied respectively with the perceived quality of the pictures and the perceived workload. Through a detailed analysis of how the professionals discussed the quality of the pictures, we re-constructed how the notion of quality of the images and being a good professional were constructed and linked. The IT system transformed into a quality system and, at the same time, transformed the notions of being a good professional. While a continuous dialogue about the quality of the pictures became an emblem for the quality of care, this dialogue was hindered by the system and the way the care process was structured. Conclusion. To conceptualize what telemedicine does in interdisciplinary work practices, a fine-tuned analysis is needed to assess how IT systems re-shape the social relations between professional groups. Such transformations should not be exclusively attributed to the technology itself or to the professionals working with it. Instead we need to assess these technologies through an empirically grounded study of the sociotechnical functioning of telemedicine. http://repub.eur.nl/res/pub/19465/ 2008-08-01T00:00:00Z Summary Objective: CVZ has asked us to provide a comparison of criteria and procedures that different countries use to determine entitlements to medical specialist care. This question was asked within the context of the recent introduction of the DBC (diagnosis treatment combinations) system as an alternative to existing methods of financing of hospital services. Methods The analysis covered priority systems in nine countries: Australia, Belgium, Canada, France, Germany, the Netherlands, Sweden, Switzerland, and the UK. To meaningfully compare existing criteria and procedures of different countries and analyze the possibilities and limitations of priority setting systems, we used an analytical framework for international comparison recently developed by Hutton and co-workers (Hutton et al., 2006). The framework was created to encompass the many aspects of fourth hurdle systems. It can deal with the legal and political characteristics at the system level and the detailed nuances of varying assessment and decision-making procedures at the decisional level. It analyses priority systems at two levels: 1. Policy implementation: the establishment of the fourth hurdle system as a policy decision of the government, the policy objectives of the system, its legal status, and its relationships with the remainder of the health system, with other public sector bodies, and with other stakeholders, such as industry and patient groups; 2. Individual technology decision: the processes by which individual technologies are dealt with by the system, for example, assessment processes, how decisions are made, and how they are implemented. ... etc. http://repub.eur.nl/res/pub/23983/ 2008-01-01T00:00:00Z Abstract Physician-centered design for computerized physician order entry (CPOE) systems overlooks the collaborative, multi-professional nature of medical work. We analyzed the compatibility of the conceptual model of inter-professional workflow underlying a CPOE system with real-life workflow in the medication ordering and administration process. We conducted twenty-three semi-structured interviews with key informant users and analyzed the handwritten documents and computerized printouts used in daily work in a Dutch academic medical center. The interview transcripts were analyzed on the basis of three conceptual themes in the inter-professional workflow: division of tasks, flow of information, and task coordination. The CPOE system fundamentally reorganized the existing work procedures of the three professional groups involved, mainly by reassigning tasks and by reallocating areas of expertise. Although the system improved the flow of medication-related information from physicians to nurses or pharmacists, this flow was only in one direction; the system did not allow information transactions in the reverse direction. It also failed to coordinate the medication-related tasks of professionals from different disciplines. To maintain the necessary level of coordination, the professionals had been obliged to consider additional methods of communication, such as phone calls or face-to-face discussion. We identified several workflow integration issues after the implementation of a CPOE system. Our insights into these issues can help ensure that system design or redesign properly integrates all professional groups' tasks, information, and areas of expertise into those of the physicians. Only then can these systems support the actual inter-professional workflow in the medication process. http://repub.eur.nl/res/pub/36549/ 2007-12-01T00:00:00Z Recent medical informatics and sociological literature has painted the image of a new type of patient-one that is reflexive and informed, with highly specified information needs and perceptions, as well as highly developed skills and tactics for acquiring information. Patients have been re-named "reflexive consumers." At the same time, literature about the questionable reliability of web-based information has suggested the need to create both user tools that have pre-selected information and special guidelines for individuals to use to check the individual characteristics of the information they encounter. In this article, we examine suggestions that individuals must be assisted in developing skills for "reflexive consumerism" and what these particular skills should be. Using two types of data (discursive data from websites and promotional items, and supplementary data from interviews and ethnographic observations carried out with those working to sustain these initiatives), we examine how users are directly addressed and discussed. We argue that these initiatives prescribe skills and practices that extend beyond finding and assessing information on the internet and demonstrate that they include ideals of consumerism and citizenship. http://repub.eur.nl/res/pub/36842/ 2007-12-01T00:00:00Z Background. This article seeks to identify the role of databases in health policy. Access to information and communication technologies has changed traditional relationships between the state and professionals, creating new systems of surveillance and control. As a result, databases may have a profound effect on controlling clinical practice. Methods. We conducted three case studies to reconstruct the development and use of databases as policy instruments. Each database was intended to be employed to control the use of one particular pharmaceutical in the Netherlands (growth hormone, antiretroviral drugs for HIV and Taxol, respectively). We studied the archives of the Dutch Health Insurance Board, conducted in-depth interviews with key informants and organized two focus groups, all focused on the use of databases both in policy circles and in clinical practice. Results. Our results demonstrate that policy makers hardly used the databases, neither for cost control nor for quality assurance. Further analysis revealed that these databases facilitated self-regulation and quality assurance by (national) bodies of professionals, resulting in restrictive prescription behavior amongst physicians. Conclusion. The databases fulfill control functions that were formerly located within the policy realm. The databases facilitate collaboration between policy makers and physicians, since they enable quality assurance by professionals. Delegating regulatory authority downwards into a network of physicians who control the use of pharmaceuticals seems to be a good alternative for centralized control on the basis of monitoring data. http://repub.eur.nl/res/pub/35701/ 2007-11-01T00:00:00Z In The Netherlands, conditional reimbursement is considered to be a promising approach to achieving more effective and efficient pharmaceutical care. Because of its formal status and nationwide regulation, conditional reimbursement may allow governments to better control medical decision-making. To evaluate the effects of conditional reimbursement on medicine use and its performance as a policy tool, we compared observed volumes of medicine use with expected volumes. In addition, we mapped the annual growth by analysing trends in the volumes of use of all conditionally reimbursed drugs; starting with the year the drug entered the market (using macro-level data). Next we explored five cases in depth (using micro-level data) in order to explore what fraction of individual prescriptions met the requirements. We also performed qualitative research (document analysis, interviews (N = 65)) in order to obtain the stakeholders' perspectives on how the measure functions, as well as to interpret the case studies data further. The findings suggest that conditional reimbursement may be an effective policy instrument, but that several changes are needed to optimize its impact. These changes are predominantly related to transparency (e.g. conditions are set following clear procedures and criteria), legitimacy (conditions should be consistent with criteria for prioritization), feasibility of procedures to control appropriate use, and timely and appropriate commitment of the stakeholders. http://repub.eur.nl/res/pub/36873/ 2007-09-06T00:00:00Z Background. Tailor-made approaches enable the uptake of interventions as they are seen as a way to overcome the incompatibility of general interventions with local knowledge about the organisation of routine medical practice and the relationship between the patients and the professionals in practice. Our case is the Quattro project which is a prevention programme for cardiovascular diseases in high-risk patients in primary health care centres in deprived neighbourhoods. This programme was implemented as a pragmatic trial and foresaw the importance of local knowledge in primary health care and internal, or locally made, guidelines. The aim of this paper is to show how this prevention programme, which could be tailored to routine care, was implemented in primary care. Methods. An ethnographic design was used for this study. We observed and interviewed the researchers and the practice nurses. All the research documents, observations and transcribed interviews were analysed thematically. Results. Our ethnographic process evaluation showed that the opportunity of tailoring intervention procedures to routine care in a pragmatic trial setting did not result in a well-organised and well-implemented prevention programme. In fact, the lack of standard protocols hindered the implementation of the intervention. Although it was not the purpose of this trial, a guideline was developed. Despite the fact that the developed guideline functioned as a tool, it did not result in the intervention being organised accordingly. However, the guideline did make tailoring the intervention possible. It provided the professionals with the key or the instructions needed to achieve organisational change and transform the existing interprofessional relations. Conclusion. As tailor-made approaches are developed to enable the uptake of interventions in routine practice, they are facilitated by the brokering of tools such as guidelines. In our study, guidelines facilitated organisational change and enabled the transformation of existing interprofessional relations, and thus made tailoring possible. The attractive flexibility of pragmatic trial design in taking account of local practice variations may often be overestimated. http://repub.eur.nl/res/pub/36797/ 2007-06-01T00:00:00Z Hyperlinked web trust marks have been a popular topic of discussion during the past 10 years. However, the discussion has focused mostly on what these trust marks are not doing in terms of helping patients (or other lay end users) find reliable medical information on the web. In this paper, we discuss how this focus on patients and their actions with respect to trust marks, has overshadowed, if not rendered invisible, what trust marks are doing to educate medical site/information providers. We draw on data from ethnographic research conducted at the Health on the Net Foundation in 2002 and 2003 in order to explore an alternate definition of what it means to be a 'user' of a trust mark and the importance of the review process in educating site providers. We argue that understanding the work involved in the process of assigning a seal is crucial to understanding the role that the seal plays as part of the medical internet. http://repub.eur.nl/res/pub/35836/ 2007-03-01T00:00:00Z Drug treatment and reimbursement is an area of ever growing complexity in health priority setting. This paper assesses the National Registry of Growth Hormone Treatment (LRG) responsible for making prioritisation decisions in the Dutch drug reimbursement system in the treatment of growth hormone, using the framework for fairness. We used qualitative research consisting of semi-structured interviews and focus group sessions combined with quantitative methods to audit the decisions of the forum. The rationing decisions of the forum demonstrate accountability for reasonableness by the conditions for transparency, relevance, and appeal. Most rationales for the decisions are public and transparent. The patients and paediatricians see decisions made by the LRG as clinical and therefore relevant decisions. They also refer to extensive appeal procedures. The case also raises important issues regarding the legitimacy of expert-based priority setting as the cyclic nature of guideline development conflicts with the need for maintaining strict rationing criteria. In 13% of the patients, the sick funds did cover treatment as the forum advised them to do, but according to guideline criteria it may be unlikely that these patients have growth hormone deficiency. According to the LRG, however, only 2% of the decisions are inconsistent with the guidelines, as some criteria on what to do in case of more uncertainty, shifted. For the forum, it seems rather unthinkable to go against the professional norms, in spite of formal national regulations. For the Health Care Insurance Board (CVZ), it was not considered possible to go against national regulations, especially as professional norms have shifted without informing policy makers and patient representatives. http://repub.eur.nl/res/pub/8897/ 2006-01-01T00:00:00Z Background: The aim of this paper is to show how researchers balance between scientific rigour and localisation in conducting pragmatic trial research. Our case is the Quattro Study, a pragmatic trial on the effectiveness of multidisciplinary patient care teams used in primary health care centres in deprived neighbourhoods of two major cities in the Netherlands for intensified secondary prevention of cardiovascular diseases. Methods: For this study an ethnographic design was used. We observed and interviewed the researchers and the practice nurses. All gathered research documents, transcribed observations and interviews were analysed thematically. Results: Conducting a pragmatic trial is a continuous balancing act between meeting methodological demands and implementing a complex intervention in routine primary health care. As an effect, the research design had to be adjusted pragmatically several times and the intervention that was meant to be tailor-made became a rather stringent procedure. Conclusion: A pragmatic trial research is a dynamic process that, in order to be able to assess the validity and reliability of any effects of interventions must also have a continuous process of methodological and practical reflection. Ethnographic analysis, as we show, is therefore of complementary value.