Search

Background Increased electronic cigarette (ECIG) use has motivated new regulations to address the changing landscape of tobacco use and promote public health. Method This policy scan compares ECIG prevalence and regulations in the European Union (EU), Canada, and the United States (US) at the federal- and local-level to foster a policy dialogue around modern tobacco prevention and control regulations. Results Among young adults, 40 % in the US, 29 % in Canada, and 28 % in the EU report ever using an ECIG. Results from the policy scan find significant variation in approach to regulating ECIGs. EU member states are subject to the most stringent requirements regarding nicotine concentration regulations, and several member states have also opted to ban flavors and/or require plain packaging or out of sight retail sales. Among EU and US states, taxation is a popular strategy, though taxing strategies vary widely. Regarding youth use, US states have led the way for increasing the legal age of sale to 21 at the federal level, and in Canada recent federal regulations are innovative in their approach to banning advertising that may appeal to youth. Conclusion Strategies to achieve public health goals related to ECIGs vary widely, with federalism playing an important role in policy innovation, offering opportunities to evaluate their effectiveness and inform future regulations.

The 4th PPRI Conference, held in Vienna in October 2019, addressed issues related to equitable and affordable access to medicines. A multi-stakeholder audience from around the globe discussed solutions and best practice models for current challenges such as high-priced medicines, limitations of current pricing and reimbursement policies and tight budgets for health technologies. A multi-faceted approach (so-called balance, evidence, collaboration and transparency/BECT strategy) was also discussed. This includes an improved balance of different interests and policy areas, generation of relevant evidence, collaboration between countries and stakeholders, and transparency, and was considered as the most promising pathway for the future.

Background: Oral health has received increased attention over the past few years coupled with rising awareness on the impact of limited dental care coverage for oral health and general health and well-being. The purpose of the study was to compare the statutory coverage and access to dental care for adult services in 11 European countries using a vignette approach.Methods: We used three patient vignettes to highlight the differences of the dimensions of coverage and access to dental care (coverage, cost-sharing and accessibility). The three vignettes describe typical care pathways for patients with the most common oral health conditions (caries, periodontal disease, edentulism). The vignettes were completed by health services researchers knowledgeable on dental care, dentists, or teams consisting of a health systems expert working together with dental specialists.Results: Completed vignettes were received from 11 countries, including Bulgaria, Estonia, France, Germany, Republic of Ireland (Ireland), Lithuania, the Netherlands, Poland, Portugal, Slovakia and Sweden. While emergency dental care, tooth extraction and restorative care for acute pain due to carious lesions are covered in most responding countries, root canal treatment, periodontal care and prosthetic restoration often require cost-sharing or are entirely excluded from the benefit basket. Regular dental visits are also limited to one visit per year in many countries. Beyond financial barriers due to out-of-pocket payments, patients may experience very different kinds of physical barriers to access dental care. Major access barriers to public dental care represent the limited availability of contracted dentists especially in rural areas and the unequal distribution and lack of specialised dentists.Conclusions: According to the results, statutory coverage of dental care varies across European countries while access barriers are largely similar. Many dental services require substantial cost-sharing in most countries which in turn leads to high out-of-pocket spending. The individual socioeconomic status is thus a main determinant for access to dental care, but also other factors such as geography, age and comorbidities can inhibit access and affect outcomes. Moreover, coverage in most oral health systems is targeted at treatment and less at preventative oral health care.

Background and purpose: Complex surgery and radiotherapy are the central pillars of loco-regional oncology treatment. This paper describes the reimbursement schemes used in radiation and complex surgical oncology, reports on literature and policy reviews. Material and methods: A systematic review of the literature of the reimbursement models has been carried out separately for radiotherapy and complex cancer surgery based on PRISMA guidelines. Using searches of PubMed and grey literature, we identified articles from scientific journals and reports published since 2000 on provider payment or reimbursement systems currently used in radiation oncology and complex cancer surgery, also including policy models. Results: Most European health systems reimburse radiotherapy using a budget-based, fee-for-service or fraction-based system; while few reimburse services according to an episode-based model. Also, the reimbursement models for cancer surgery are mostly restricted to differences embedded in the DRG system and adjustments applied to the fees, based on the complexity of each surgical procedure. There is an enormous variability in reimbursement across countries, resulting in different incentives and different amounts paid for the same therapeutic strategy. Conclusion: A reimbursement policy, based on the episode of care as the basic payment unit, is advocated for. Innovation should be tackled in a two-tier approach: one defining the common criteria for reimbursement of proven evidence-based interventions; another for financing emerging innovation with uncertain definitive value. Relevant clinical and economic data, also collected real-life, should support reimbursement systems that mirror the actual cost of evidence-based practice. (C) 2021 The Author(s). Published by Elsevier Ltd. on behalf of British Association of Surgical Oncology and European Society of Surgical Oncology, and Elsevier B.V.

Background: The reimbursement of new technologies in inpatient care is not always linked to a requirement for evidence-based evaluation of patient benefit. In Germany, every new technology approved for market was until recently reimbursable unless explicitly excluded. It was therefore unclear whether the implementation of innovative technologies is guided by scientific evidence. This work aimed to explore the relationship between clinical evidence and utilization for 25 selected technologies in German inpatient care.Methods: Different methods were applied. A systematic search for evidence published between 2003 and 2017 was conducted in four bibliographic databases; clinical trial registries; resources for clinical guidelines; and health technology assessment - databases. Information was also collected on funding mechanisms and safety notices. Utilization was measured by hospital cases captured in claims data. The body of evidence, funding and safety notices per technology were analysed descriptively. The relationship between utilization and evidence was explored empirically using a multilevel regression analysis.Results: The number of included publications per technology ranges from two to 498. For all technologies, non-comparative studies form the bulk of the evidence. The number of randomised controlled clinical trials per technology ranges from zero to 19. Some technologies were utilized for several years without an adequate evidence base. A relationship between evidence and utilization could be shown for several but not all technologies.Conclusions: This study reveals a mixed picture regarding the evidence available for new technologies, and the relationship between the development of evidence and the use of technologies over time. Although the influence of funding and safety notices requires further investigation, these results re-emphasize the need for strengthening market approval standards and HTA pathways as well as approaches such as “coverage with evidence development”.

At the onset of the COVID-19 pandemic, health care providers had to abruptly change their way of providing care in order to simultaneously plan for and manage a rise of COVID-19 cases while maintaining essential health services. Even the most well-resourced health systems faced pressures from new challenges brought on by COVID-19, and every country had to make difficult choices about how to maintain access to essential care while treating a novel communicable disease. Using the information available on the HSRM platform from the early phases of the pandemic, we analyze how countries planned services for potential surge capacity, designed patient flows ensuring separation between COVID-19 and non-COVID-19 patients, and maintained routine services in both hospital and outpatient settings. Many country responses displayed striking similarities despite very real differences in the organization of health and care services. These include transitioning the management of COVID-19 mild cases from hospitals to outpatient settings, increasing the use of remote consultations, and cancelling or postponing non-urgent services during the height of the first wave. In the immediate future, countries will have to continue balancing care for COVID-19 and non-COVID-19 patients to minimize adverse health outcomes, ideally with supporting guidelines and COVID-19-specific care zones. Many countries expect to operate at lower capacity for routinely provided care, which will impact patient access and waiting times. Looking forward, policymakers will have to consider whether strategies adopted during the COVID-19 pandemic will become permanent features of care provision.

ObjectivesTo (1) describe the (evidence-based) reimbursement process of hospital individual services, (2) evaluate the accordance between evidence-based recommendations and reimbursement decision of individual services and (3) elaborate potential aspects that play a role in the decision-making process in Austria.Method:The reimbursement process is described based on selected relevant sources such as official documents. Evidence-based recommendations and subsequent reimbursement decisions for the annual maintenance of the hospital individual service catalogue in Austria between 2008 and 2020 were analysed using a mixed methods approach, encompassing descriptive statistics and a focus group with Austrian decision makers. Results:118 evidence-based recommendations were analysed. There were 93 (78.8%) negative and 25 (21.2%) positive evidence-based recommendations. In total, 107 out of 118 evidence-based recommendations (90.1%) did not lead to a deviating reimbursement decision. We identified six aspects that may have played a role in the decision-making process for the annual maintenance of the hospital individual service catalogue, with clinical evidence being the most notable. Further aspects included quality assurance/organisational aspects (i.e., structural quality assurance), costs (if comparable to already existing medical services, not: cost-effectiveness), procedural aspects (e.g., if certain criteria for adoption have not been met formally through the proposals), “other countries” (i.e., taking into account how other countries decided) and situational aspects (such as the COVID-19 pandemic).Conclusions:There is good accordance between evidence-based recommendations and reimbursement decisions regarding hospital individual services in Austria. Beyond clinical evidence, organizational aspects seem to be considered often with regard to quality assurance but costs do not appear to play a major role. The Austrian system has mechanisms in place that can restrict widespread adoption of novel hospital individual services with uncertain clinical benefits. Future studies could investigate how well these mechanisms work and how they compare to other health systems in Europe.

The COVID-19 pandemic has placed unprecedented pressure on health systems' capacities. These capacities include physical infrastructure, such as bed capacities and medical equipment, and healthcare professionals. Based on information extracted from the COVID-19 Health System Reform Monitor, this paper analyses the strategies that 45 countries in Europe have taken to secure sufficient health care infrastructure and workforce capacities to tackle the crisis, focusing on the hospital sector. While pre-crisis capacities differed across countries, some strategies to boost surge capacity were very similar. All countries designated COVID-19 units and expanded hospital and ICU capacities. Additional staff were mobilised and the existing health workforce was redeployed to respond to the surge in demand for care. While procurement of personal protective equipment at the international and national levels proved difficult at the beginning due to global shortages, countries found innovative solutions to increase internal production and enacted temporary measures to mitigate shortages. The pandemic has shown that coordination mechanisms informed by real-time monitoring of available health care resources are a prerequisite for adaptive surge capacity in public health crises, and that closer cooperation between countries is essential to build resilient responses to COVID-19.

The rapid rollout of Israel’s vaccination program has led to considerable international interest. In this brief commentary we consider how the criteria for vaccination priority groups differ between Israel and selected European countries. We argue that following the Israeli approach of using broad criteria for prioritization— i.e. having fewer groups and a lower age threshold— could have several beneficial effects, including more manageable logistics and fewer roll out delays, as well as potentially reducing pressure on hospitals. With an increasing supply of vaccines becoming available rapidly in much of Europe, countries could consider following the approach of Israel and adopting broader priority criteria going forward.

Background Oral health is an important component of general health and healthy aging, yet financial protection for the costs of oral health care is often limited. Methods We systematically compare dental care coverage in Australia (New South Wales), Canada (Alberta), England, France, Germany, Italy, Sweden, and the United States. Drawing on the WHO Universal Coverage Cube, we compare breadth (who is covered), depth (share of total costs covered), and scope (services covered), with a focus on adults aged 65 and older. We populated data collection templates to provide detailed and comparable descriptions of dental care coverage in 8 jurisdictions. Results Overall there were four general types of coverage models: 1) deep public coverage for a small subset of the population based on strict eligibility criteria jurisdictions: Canada, Australia and Italy; 2) universal but shallow coverage of the population, combined with deeper coverage for a sub-set of the population meeting eligibility criteria: England, France, Sweden; 3) universal, and predominantly deep coverage for the whole population: Germany; and 4) shallow coverage available to some subgroups of the population in the United States. Conclusions While age, specifically turning 65, is an important consideration in the design of public coverage in Canada, Australia and the United States, many jurisdictions do not consider age as an eligibility criterion for public coverage. Yet all jurisdictions we include, except Sweden, provide differential coverage for those who meet a specific low-income threshold. Due to the limited availability of comparable data within and across jurisdictions, further research would benefit from standardized data collection initiatives for oral health measures. Key message Given the important role oral health plays in promoting healthy aging, the limited public coverage of oral health within statutory health systems warrants policy and research attention.

Background In Europe, countries have adopted very different approaches to providing publicly subsidized dental insurance coverage. However, little attention has been paid on these variations in the coverage, financing and provision of oral health care and its implications. This cross-country Health Systems in Transition (HiT) Review aims to fill this gap in the field of comparison of oral health systems. Methods The comparative HiT draws on multiple data sources. It builds on detailed country information from national HiTs and other international sources (MISSOC, OECD/OBS country profiles). International databases (Eurostat, OECD, EHIS, EU-SILC) are used as main sources to compare available oral health related indicators. National and international policy documents and information by country experts complement this information. The HiT covers all EU members states and countries belonging to the EU's single market (UK, Iceland, Norway, Switzerland). Results In almost all countries, dental care is funded to a greater extent by private patient payments than other health care sectors. Overall, contribution of voluntary health insurances (VHI) to dental spending is low, while out-of-pocket spending is substantial in many countries leading to high levels of unmet needs for dental care for financial reasons, mainly for poor households. Comparison of coverage reveals that most countries commit to a minimum scope of basic dental care (emergency care, children), but there is large variation in terms of restriction of service packages ranging from countries with very limited, partial to comprehensive coverage. Conclusions Dental care has become a priority for European policy makers as countries extend statutory dental care coverage recognising the importance of prevention of oral diseases. However, there remain wide variations in the level of coverage resulting in differences of likelihood of dental care use.

Background The hitherto largely unregulated market of mobile digital health applications is undergoing significant changes, particularly concerning the growing segment of apps that aim at integrating care processes or replacing traditional forms of diagnosis or therapy. The inclusion in the benefit basket of statutory health systems is of relevance when exploring viable business models for app developers. Description of the problem So far, countries largely limit coverage to apps developed by authorities within the statutory health system, or provide guidance for payers in the form of app lists or quality assessment criteria. However, there are new regulatory efforts aiming to promote innovation for mobile digital health applications by creating pathways to general reimbursement, as exemplified by the 2019 German Digital Healthcare Act. Results Our contribution illustrates how evidence-based reimbursement decisions can be configured for mobile digital health applications. We will compare frameworks from different contexts, including the new German regulation, the UK's NHS App Store and the Evidence Standards Framework for Digital Health by NICE as well as the work of the French National Health Authority (Haute Autorité de Santé). Building on case studies, we will provide a typology of practices, which covers elements spanning consumer guidance to assessment approaches to full reimbursement decision-making. Conclusions Based on the proposed typology, we will discuss challenges and opportunities of reimbursement systems for mobile health apps from a public health perspective and seek to refine the typology by incorporating input from session participants and profiting from the global nature of the conference.

Background The aim of this study was to examine the scientific evidence on clinical effectiveness and safety used in health technology assessments (HTAs) of high-risk medical devices (MDs) in Europe. Methods We applied a systematic approach to identify European institutions involved in HTA and to select reports assessing MDs considered high-risk according to the definition in the new German health care regulation §137h. Reports published between 2010 and 2015 were considered in our subsequent analysis. We used a structured tool based on widely accepted methodologic principles from Drummond's framework to extract key information on the clinical evidence considered in the reports. Results Out of 1376 identified reports, 93 were eligible for analysis. All reports based their assessment primarily on direct evidence, in most cases (68%) identified through an independent systematic literature search. In more than half the identified studies considered in the reports, clinical evidence for demonstration of effectiveness and safety was of moderate or low quality. Even when systematic reviews and randomized controlled trials were available for assessment, most studies showed an unclear or high risk of bias. Conclusions This study confirms that the quality of scientific evidence used in HTA of high-risk MDs is low and therefore the use of evidence needs improvement. The European Commission recently updated the regulation on MDs but mainly focused on the safety of materials and the CE (Conformite Europeene [European Conformity]) mark. Our results show that additional changes are necessary, specifically with regard to the marketing authorization process of MDs, with stricter quality requirements based on methodologically robust trials, possibly in combination with other evidence sources.

Objectives Health Technology Assessment (HTA) of Medical devices (MDs) and MD-based procedures can be challenging due to the unique features and particularities of this group of technologies, such as device-operator interaction. The aim of this study was to (1) clarify, and supplement earlier findings on European HTA institutions’ structural, procedural and methodological characteristics with regard to the assessment of MDs and to (2) capture the institutions’ perceptions regarding challenges and future trends. Methods Semi-structured telephone interviews with 16 representatives from leading European HTA institutions were performed between April and July 2015. Summative and directed content analysis was used for the analysis, which is reported according to the COREQ checklist. Results Findings from the analysis of the interviews were manifold and partially confirmed what has been noted in the literature (e.g. scarce evidence; identifying relevant studies challenging due to more incremental innovations). Additional themes emerged that can be important for future considerations by HTA institutions and policy-makers alike (e.g. areas for future research; need for specific tools). Conclusions The collective opinion of 16 European HTA institutions on MD evaluation could provide ideas to ameliorate the current regulatory situation beyond the modified EU regulation and start broader, more in-depth methodological discussions around the issue. Interviewed experts seem to agree that new approaches such as coverage with evidence development as some countries already introduced could help to overcome the problem with scarce evidence.

Zelei, T., Molnár, M. J., Szegedi, M., and Kaló, Z. (2016). Systematic review on the evaluation criteria of orphan medicines in Central and Eastern European countries. Orphanet. J. Rare Dis. 11 (1), 72. doi: 10.1186/ s13023-016-0455-6 Conflict of Interest: SS is grant holder of a project on "How to reimburse and pay orphan drugs for rare diseases?" funded by the Scientific Research Foundation Flanders. This study was conducted within the statutory project: "Reimbursement and clinical aspects of orphan drug policy in Poland and Europe" (project number: K/ZDS/007863). We would like to thank Francis Arickx for help in data acquisition for Belgium. Objective: To review the reimbursement recommendations issued by selected European health technology assessment agencies for orphan drugs and the reimbursement status of these drugs; to assess the relationship between the type of recommendation and reimbursement status. Methods: The list of orphan drugs to be included in the analysis was obtained from the European Medicines Agency and Orphanet. Seven European states were included in the analysis: Belgium, England, France, Germany, Poland, Scotland, and Spain. For all identified orphan drugs, relevant data on the reimbursement status and type of recommendation were collected for each country. The relationship between the type of recommendation and reimbursement status was evaluated separately for each considered country, using Cohen's kappa coefficient for the measurement of agreement; sub-analyses for oncology and metabolic drugs were performed. Results: Most reimbursement recommendations for orphan drugs were positive (71%), while approximately 17% were negative and almost 13% were conditional. The highest percentage of positive reimbursement recommendations was observed in Spain (97%) and France (95%) and the highest percentage of negative reimbursement recommendations was revealed for Poland (49%). On average, 65% of the 163 analyzed orphan drugs were reimbursed from public funds. The highest number of reimbursed orphan drugs was observed in Germany (n = 148), while the lowest, in Poland (n = 41). Considering all analyzed drugs, the highest agreement between recommendations and reimbursement status was observed for Spain (value of 1), and the lowest, for Germany (κ = -0.03). Conclusions: On average, more than 60% of identified orphan drugs were reimbursed from public funds in the included countries, and the majority of reimbursement recommendations were found to be positive. The agreement between reimbursement recommendations and reimbursement status differed between the countries, but overall, it did not show any patterns, as it ranged from -0.03 to 1 (κ coefficient).

Objectives A common characteristic of sending countries in cross-border dental care is that of high costs and/or high copayments for dental services. This study aims to provide an insight into the characteristics of German patients receiving planned and emergency (unplanned) dental care abroad and their satisfaction with received services. Methods The Europabefragung is a postal survey carried out by Techniker Krankenkasse for patients who are treated in EU/EEA countries. This study uses data from the Europabefragung 2012. The survey was sent to 45 189 individuals; descriptive statistics for the subset of respondents who received emergency (unplanned) or planned dental treatment are presented. Results There were 18 339 responses to the questionnaire, out of which 17 543 were deemed valid; 1416 respondents had received emergency (unplanned) (78%) or planned (22%) dental care and were included in the analysis. There were clear differences between unplanned and planned treatments regarding country and type of treatment as well as satisfaction with different aspects of treatment and the need for follow-up care. Overall, satisfaction with treatment was high for both groups; individuals who had received planned treatment were more satisfied on all aspects of care and reported a need for follow-up care less frequently. Conclusions While German patients who received both emergency (unplanned) and planned services abroad are mostly satisfied with their experience, some concerns arise with regard to continuity of care. Types of information provided to patients seeking care abroad and dissemination modalities should be carefully planned.

Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG geförderten) Allianz- bzw. Nationallizenz frei zugänglich. This publication is with permission of the rights owner freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively. Objective While Directive 2011/24/EU on cross-border patient mobility makes specific provisions in relation to information availability and accessibility, little empirical evidence exists to guide best practice. This paper explores the information-seeking behaviour of German patients who received planned care abroad. Methods A postal survey among German patients treated in other European countries was carried out by Techniker Krankenkasse, a major German sickness fund. The influence of certain predictors on whether patients informed themselves before travelling for care was investigated using multiple logistic regression. Types and sources of information were analysed using descriptive statistics. Results Information activity was contingent on patients' level of education, type of service, regularity of treatment abroad and awareness of entitlement to cross-border services. Respondents most frequently enquired about elements of reimbursement, entitlement to services and cost-saving, and consulted their sickness fund for information. Differences in both content and medium of choice were observed between patient groups. Conclusion A structured and inclusive approach to information provision should be adopted. National Contact Points should collaborate with a range of stakeholders, who will vary depending on the health care system; however, patient organizations, health professionals and third-party payers should always be represented. Dynamically monitoring cross-border movements can help determine the range, medium and language of relevant information.

Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG geförderten) Allianz- bzw. Nationallizenz frei zugänglich. This publication is with permission of the rights owner freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively. Objectives: The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices. Methods: Several classifications for medical devices based on varying rationales for different regulatory and reporting purposes were analyzed in detail to develop a comprehensive taxonomic model. Results: The taxonomy is based on relevant aspects of existing classification schemes incorporating elements of risk and functionality. Its 9 × 6 matrix distinguishes between the diagnostic or therapeutic nature of devices and considers whether the medical device is directly used by patients, constitutes part of a specific procedure, or can be used for a variety of procedures. We considered the relevance of different device categories in regard to HTA to be considerably variable, ranging from high to low. Conclusions: Existing medical device classifications cannot be used for HTA as they are based on different underlying logics. The developed taxonomy combines different device classification schemes used for different purposes. It aims at providing decision makers with a tool enabling them to consider device characteristics in detail across more than one dimension. The placement of device groups in the matrix can provide decision support on the necessity of conducting a full HTA.

This paper reviews procedures for ensuring that physicians in the European Union (EU) continue to meet criteria for registration and the implications of these procedures for cross-border movement of health professionals following implementation of the 2005/36/EC Directive on professional qualifications. A questionnaire was completed by key informants in 10 EU member states, supplemented by a review of peer-reviewed and grey literature and a review conducted by key experts in each country. The questionnaire covered three aspects: actors involved in processes for ensuring continued adherence to standards for registration and/or licencing (such as revalidation), including their roles and functions; the processes involved, including continuing professional development (CPD) and/or continuing medical education (CME); and contextual factors, particularly those impacting professional mobility. All countries included in the study view CPD/CME as one mechanism to demonstrate that doctors continue to meet key standards. Although regulatory bodies in a few countries have established explicit systems of ensuring continued competence, at least for some doctors (in Belgium, Germany, Hungary, the Netherlands, Slovenia and the UK), self-regulation is considered sufficient to ensure that physicians are up to date and fit to practice in others (Austria, Finland, Estonia and Spain). Formal systems vary greatly in their rationale, structure, and coverage. Whereas in Germany, Hungary and Slovenia, systems are exclusively focused on CPD/CME, the Netherlands also includes peer review and minimum activity thresholds. Belgium and the UK have developed more complex mechanisms, comprising a review of complaints or compliments on performance and (in the UK) colleague and patient questionnaires. Systems for ensuring that doctors continue to meet criteria for registration and licencing across the EU are complex and inconsistent. Participation in CPD/CME is only one aspect of maintaining professional competence but it is the only one common to all countries. Thus, there is a need to bring clarity to this confused landscape.

Purpose and setting This review aimed to evaluate the effectiveness of strategies to implement clinical guidelines for chronic disease management in primary care in EU Member States. Methods We conducted a systematic review of interventional studies assessing the implementation of clinical guidelines. We searched five databases (EMBASE, MEDLINE, CENTRAL, Eppi-Centre and Clinicaltrials.gov) following a strict Cochrane methodology. We included studies focusing on the management of chronic diseases in adults in primary care. Results A total of 21 studies were found. The implementation strategy was fully effective in only four (19%), partially effective in eight (38%), and not effective in nine (43%). The probability that an intervention would be effective was only slightly higher with multifaceted strategies, compared to single interventions. However, effect size varied across studies; therefore it was not possible to determine the most successful strategy. Only eight studies evaluated the impact on patients’ health and only two of those showed significant improvement, while in five there was an improvement in the process of care which did not translate into an improvement in health outcomes. Only four studies reported any data on the cost of the implementation but none undertook a cost-effectiveness analysis. Only one study presented data on the barriers to the implementation of guidelines, noting a lack of awareness and agreement about clinical guidelines. Conclusion Our results reveal that there are only a few rigorous studies which assess the effectiveness of a strategy to implement clinical guidelines in Europe. Moreover, the results are not consistent in showing which strategy is the most appropriate to facilitate their implementation. Therefore, further research is needed to develop more rigorous studies to evaluate health outcomes associated with the implementation of clinical guidelines; to assess the cost-effectiveness of implementing clinical guidelines; and to investigate the perspective of service users and health service staff.

Background The issue of continuity in cross-border health care has been discussed in research and was picked up in the recently transposed Directive on Patients' Rights in Cross-border Healthcare (2011/24/EU). However, there is limited evidence about related issues actually encountered by patients crossing borders. These patients do not only transition between different levels of care or separate providers. They also move from one health care system to another, often …

Objective. This paper explores how medical regulatory bodies in nine European countries manage professional issues involving quality and patient safety, to build on limited existing information on procedures for regulating medical professionals in Europe. Design. Twelve vignettes describing scenarios of concerns about standards of physicians were developed, covering clinical, criminal and administrative matters. Medical regulatory bodies in nine European countries were asked what action they would normally take in each situation. Their responses were related to their regulatory mandate. Results. Responses varied greatly across participating countries. Regulators are always involved where patients are at risk or where a criminal offence is committed within the clinical setting. Non-criminal medical issues were generally handled by the employer, if any, at their discretion. Countries varied in the use of punitive measures, the extent to which they took an interest in issues arising outside professional activities, and whether they dealt with issues themselves or referred cases to another regulatory authority or took no action at all. Conclusions. There is little consistency across Europe on the regulation of medical professionals. There is considerable diversity in the range of topics that regulatory bodies oversee, with almost all covering health care quality and safety and others encompassing issues related to reputation, respect and trust. These inconsistencies have significant implications for professional mobility, patient safety and quality of care.

Background Several high profile cases of medical malpractice have raised concerns about the management by regulatory bodies of the performance of doctors working outside their native country within Europe. This paper will assess the roles of and consistencies between regulatory bodies in nine European countries on how they regulate quality of health care and patient safety. Methods Twelve vignettes describing scenarios that raise concerns about standards of physicians were designed by the …

Background The hospital discharge summary, a succinct resume of a specific episode of care, is a highly relevant health record to support continuity of care of a patient moving between providers, levels of care and across national borders. This is particularly relevant in light of the recently adopted Directive 2011/24 on the application of patients' rights in cross-border healthcare. Methods …

Introduction The use of evidence-based clinical guidelines is an essential component of chronic disease management. However, there is well-documented concern about variability in the quality of clinical guidelines, with evidence of persisting methodological shortcomings. The most widely accepted approach to assessing the quality of guidelines is the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. We have conducted a systematic review of the methodological quality (as assessed by AGREE) of clinical guidelines developed in Europe for the management of chronic diseases published since 2000. Methods The systematic review was undertaken in accordance with the Cochrane methodology. The inclusion criteria were that studies should have appraised European clinical guidelines for certain selected chronic disorders using the AGREE instrument. We searched five databases (Cab Abstracts, EMBASE, MEDLINE, Trip and EPPI). Results Nine studies reported in 10 papers, analysing a total of 28 European guidelines from eight countries as well as pan-European, were included. There was considerable variation in the quality of clinical guidelines across the AGREE domains. The least well addressed domains were ‘editorial independence’ (with a mean domain score of 41%), ‘applicability’ (44%), ‘stakeholder involvement’ (55%), and ‘rigour of development’ (64%), while ‘clarity of presentation’ (80%) and ‘scope and purpose’ (84%) were less problematic. Conclusion This review indicates that there is considerable scope for improvement in the methods used to develop clinical guidelines for the prevention, management and treatment of chronic diseases in Europe. Given the importance of decision support strategies such as clinical guidelines in chronic disease management, improvement measures should include the explicit and transparent involvement of key stakeholders (especially scientific experts, guideline users and methodological specialists) and consideration of the implications for guideline implementation and applicability early on in the process.

In 1974, the European Economic Community established mutual recognition of medical qualifications obtained in any of its member states. Subsequently, a series of directives has elaborated on the initial provisions, with the most recent enacted in 2013. However, greater movement of physicians across borders and some high-profile scandals have raised questions about how to prevent a physician sanctioned in one country from simply moving to another, without undermining the principle of free movement. A survey of key informants in 11 European Union (EU) member states was supplemented by a review of peer-reviewed and grey literature, with the results validated by independent reviewers. It examined processes, adjudicative and disciplinary measures that are in place to evaluate physicians about whom concerns arise, and related sanctions, along with other aspects of professional standards and regulation. Overall, responses varied greatly between participating countries, with respect to the institutions responsible for the regulation of medical professions, the investigation processes in place, and the terminology used in each member state. While the types of sanction (removal from the register of medical professionals and/or licence revocation, suspension, dismissal, reprimand, warnings, fines, as well as additional education and training) applied are similar, both the roles of the individuals involved and the level of public disclosure of information vary considerably. However, some key features, such as the involvement of professional peers in disciplinary panels and the involvement of courts in criminal cases, are similar in most member states studied. Given the variation in the regulatory context, individuals and processes involved that is illustrated by our findings, a common understanding of definitions of what constitutes competence to practise, its impairment and its potential impact on patient safety becomes particularly important. Public disclosure of disciplinary outcomes is already applied by some member states, but additional measures should be considered to protect medical professionals from undue consequences.

Background Dissemination bias occurs when only some results emerging from clinical research reach their intended audience in the knowledge translation process. Given that coverage decisions increasingly rely on evidence, it is important to explore the types of evidence considered. This paper aimed to examine the evidence base used by regulatory institutions involved in pricing and reimbursement of pharmaceuticals in a broad range of European countries, as well as their awareness of and approach towards dissemination bias. Methods A mixed methods approach was adopted. Regulatory documents and published literature were identified in systematic searches and relevant documents were analysed. An online survey was carried out to verify and expand insights. Results Forty-two relevant regulatory documents and 10 publications were included. The survey had a 35% response rate, yielding valid responses for 13 countries. A fragmented impression was obtained for most countries indicating a general lack of transparency regarding both processes of decision-making and approaches towards unpublished information. Dissemination bias was rarely consistently considered. Practices for the identification and inclusion of all available evidence varied considerably, as did the influence of missing evidence on decision-making. Differences were often attributable to the regulatory context and/or institutional principles. Conclusions Best practice is difficult to generalize given the identified variations. Individual exemplary practices support the necessity for institutional exchange at international level. Increased institutional commitment to transparency of methods and processes should be advocated. Electronic supplementary material The online version of this article (doi:10.1186/s12961-016-0080-9) contains supplementary material, which is available to authorized users.