C. Wild

BEST PRACTICE IN UNDERTAKING AND REPORTING HEALTH TECHNOLOGY ASSESSMENTS

[Executive Summary] The aim of Working Group 4 has been to develop and disseminate best practice in undertaking and reporting assessments, and to identify needs for methodologic development. Health technology assessment (HTA) is a multidisciplinary activity that systematically examines the technical performance, safety, clinical efficacy, and effectiveness, cost, costeffectiveness, organizational implications, social consequences, legal, and ethical considerations of the application of a health technology (18). HTA activity has been continuously increasing over the last few years. Numerous HTA agencies and other institutions (termed in this report “HTA doers”) across Europe are producing an important and growing amount of HTA information. The objectives of HTA vary considerably between HTA agencies and other actors, from a strictly political decision making–oriented approach regarding advice on market licensure, coverage in benefits catalogue, or investment planning to information directed to providers or to the public. Although there seems to be broad agreement on the general elements that belong to the HTA process, and although HTA doers in Europe use similar principles (41), this is often difficult to see because of differences in language and terminology. In addition, the reporting of the findings from the assessments differs considerably. This reduces comparability and makes it difficult for those undertaking HTA assessments to integrate previous findings from other HTA doers in a subsequent evaluation of the same technology. Transparent and clear reporting is an important step toward disseminating the findings of a HTA; thus, standards that ensure high quality reporting may contribute to a wider dissemination of results. The EUR-ASSESS methodologic subgroup already proposed a framework for conducting and reporting HTA (18), which served as the basis for the current working group. New developments in the last 5 years necessitate revisiting that framework and providing a solid structure for future updates. Giving due attention to these methodologic developments, this report describes the current “best practice” in both undertaking and reporting HTA and identifies the needs for methodologic development. It concludes with specific recommendations and tools for implementing them, e.g., by providing the structure for English-language scientific summary reports and a checklist to assess the methodologic and reporting quality of HTA reports.

Telerehabilitation in stroke care – a systematic review:

We conducted a systematic review of telerehabilitation interventions in stroke care. The following databases were searched: Medline, Embase, DARE-NHSEED-HTA (INAHTA) and the Cochrane Library. Nine studies, all published after 2000, were included in the review. A wide variety of telemedicine interventions in post-stroke rehabilitation care was identified. Four studies had been carried out in the USA, two in the Netherlands, two in Italy and one in China. There were four randomized controlled trials and one qualitative analysis. Four studies used an observational study design/case series. Home-based telerehabilitation interventions showed promising results in improving the health of stroke patients and in supporting caregivers. Telemedicine systems based on a virtual environment for upper extremity exercise can improve the physical health of stroke patients. Health professionals and participants reported high levels of satisfaction and acceptance of telerehabilitation interventions. There was no evidence regarding the effects on resource utilization or cost-effectiveness. Most studies showed promising results, although overall, the quality of the evidence on telerehabilitation in post-stroke care was low.

Telemedicine in acute stroke management: systematic review.

OBJECTIVES Stroke is the third largest cause of death and a major factor in permanent disability. Disparities in access to healthcare services exist due to geographical barriers and limited resources. Rural locations often lack the resources for adequate acute stroke care. Telestroke is intended to enable the transfer of knowledge of acute stroke management to areas with limited neurological services. The objective of this study is to assess the feasibility, acceptability, and treatment delivery reliability of telemedicine systems in acute stroke management. METHODS A systematic review was undertaken. RESULTS Eighteen studies were included in this systematic review. Telestroke services have been reported to lead to better functional health outcomes, including reduced mortality and dependency, compared with conventional care. Most studies report that systemic tissue plasminogen activator (tPA) treatment increased in hospitals providing telestroke services, although patients were often transferred to a stroke center for continuing monitoring and surveillance. Patients and healthcare providers reported high levels of satisfaction. There was limited evidence regarding the impact on resource utilization and cost-effectiveness. CONCLUSIONS Telemedicine systems can be safe, feasible, and acceptable in acute stroke management. Telestroke is associated with increased delivery of tPA. The lack of standardized measuring and reporting of resources and health outcomes hinder comparisons between telestroke networks and the determination of best practices. More research is needed to explore the clinical and economic impact of telemedicine technologies in acute stroke management, so as to support policy makers in making informed decisions.

European network for Health Technology Assessment, EUnetHTA: Planning, development, and implementation of a sustainable European network for Health Technology Assessment

OBJECTIVES The European network on Health Technology Assessment (EUnetHTA) aimed to produce tangible and practical results to be used in the various phases of health technology assessment and to establish a framework and processes to support this. This article presents the background, objectives, and organization of EUnetHTA, which involved a total of sixty-four partner organizations. METHODS Establishing an effective and sustainable structure for a transnational network involved many managerial, policy, and methodological tools, according to the objective of each task or Work Package. Transparency in organization, financial transactions, and decision making was a key principle in the management of the Project as was the commitment to appropriately involve stakeholders. RESULTS EUnetHTA activities resulted in a clear management and governance structure, efficient partnership, and transnational cooperation. The Project developed a model for sustainable continuation of the EUnetHTA Collaboration. CONCLUSIONS The EUnetHTA Project achieved its goals by producing a suite of practical tools, a strong network, and plans for continuing the work in a sustainable EUnetHTA Collaboration that facilitates and promotes the use of HTA at national and regional levels. Responsiveness to political developments in Europe should be balanced with maintaining a high level of ambition to promote independent, evidence-based information and well-tested tools for best practice based on a strong network of HTA institutions.

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

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

EXTRACORPOREAL SHOCK WAVE THERAPY IN ORTHOPEDICS

OBJECTIVE Extracorporeal shock wave therapy (ESWT) as an emerging technology in orthopedics has been assessed in Austria with the objective to establish a scientific basis for pending and pressing health policy decisions. Despite encouraging results within some indications and the promising prospect of a noninvasive treatment for some orthopedic diseases, it seemed crucial to assess this new field of application in the light of evidence-based standards, without forgetting the reality of healthcare decisions. This article presents the results of the above mentioned assessment in the context of the policy-making process in Germany, Austria, and Switzerland. METHODS The study is based on an overview of the already existing reviews on the effectiveness of ESWT as carried out by different actors (health insurances and orthopedists), and on an overview of additional literature covering all relevant aspects (mode of action, recommendations, economic estimates). Orthopedic societies, several institutions involved in health technology assessment, and health insurance agencies were contacted in search of further relevant literature, ongoing studies, and assessments. RESULTS Until now, clear evidence has not been available on the effectiveness of ESWT in four currently recommended indications (tendinosis calcarea of the shoulder, epicondylopathia humeri radialis, calcaneal spur, and pseudarthrosis), although a substantial body of literature has been produced. Despite encouraging results in some indications, the lack of coherent therapy schemes and the poor quality in the design of clinical studies has been serious enough to hinder the drawing of reasonable conclusions. CONCLUSIONS Due to the rapid diffusion of ESWT and the pressure on reimbursement agencies to prove the ineffectiveness of ESWT, the policy option of a pragmatic approach is recommended to control the diffusion of an uncertain health technology, alongside active research that would allow a more comprehensive appraisal of this potentially interesting treatment strategy in orthopedics.

Commentary: Europe needs a central, transparent, and evidence based regulation process for devices

Last September, the European Commission published proposals to update regulations for medical devices in order to improve patient safety.1 The proposals are being discussed by the European parliament where critical debate is being led by the Committee on Environment, Public Health and Food Safety. Medical devices range from bandages to life support machines, and manufacturers classify them into four risk categories from low (such as urine drainage bags) to high risk (such as drug eluting cardiac stents) according to EU rules.2 The risk associated with the device depends on the duration of contact with the body, invasiveness, and whether it has a local or a systemic effect. Medium and high risk devices must be certified by one of the notified bodies, organisations that are accredited to assess a product’s compliance with EU legislation (CE mark). At a …

Decision support in vaccination policies.

BACKGROUND Looking across boarders reveals that the national immunization programs of various countries differ in their vaccination schedules and decisions regarding the implementation and funding of new vaccines. The aim of this review is to identify decision aids and crucial criteria for a rational decision-making process on vaccine introduction and to develop a theoretical framework for decision-making based on available literature. METHODS Systematic literature search supplemented by hand-search. RESULTS We identified five published decision aids for vaccine introduction and program planning in industrialized countries. Their comparison revealed an overall similarity with some differences in the approach as well as criteria. Burden of disease and vaccine characteristics play a key role in all decision aids, but authors vary in their views on the significance of cost-effectiveness analyses. Other relevant factors that should be considered before vaccine introduction are discussed to highly differing extents. These factors include the immunization program itself as well as its conformity with other programs, its feasibility, acceptability, and equity, as well as ethical, legal and political considerations. Assuming that the most comprehensive framework possible will not provide a feasible tool for decision-makers, we suggest a stepwise procedure. CONCLUSIONS Though even the best rational approach and most comprehensive evaluation is limited by remaining uncertainties, frameworks provide at least a structured approach to evaluate the various aspects of vaccine implementation decision-making. This process is essential in making consistently sound decisions and will facilitate the publics confidence in the decision and its realization.

Hospital managers’ need for information in decision-making – An interview study in nine European countries

Assessments of new health technologies in Europe are often made at the hospital level. However, the guidelines for health technology assessment (HTA), e.g. the EUnetHTA Core Model, are produced by national HTA organizations and focus on decision-making at the national level. This paper describes the results of an interview study with European hospital managers about their need for information when deciding about investments in new treatments. The study is part of the AdHopHTA project. Face-to-face, structured interviews were conducted with 53 hospital managers from nine European countries. The hospital managers identified the clinical, economic, safety and organizational aspects of new treatments as being the most relevant for decision-making. With regard to economic aspects, the hospital managers typically had a narrower focus on budget impact and reimbursement. In addition to the information included in traditional HTAs, hospital managers sometimes needed information on the political and strategic aspects of new treatments, in particular the relationship between the treatment and the strategic goals of the hospital. If further studies are able to verify our results, guidelines for hospital-based HTA should be altered to reflect the information needs of hospital managers when deciding about investments in new treatments.

Systematische Übersichtsarbeiten und Meta-Analysen

Over the past years, systematic reviews and meta-analyses have led to significant changes in clinical medicine and health policy. To date, they can be viewed as the most objective instruments to answer clinical as well health policy questions. In addition, systematic reviews are an important tool to synthesize the enormous amount of new medical knowledge into a manageable format. Nevertheless, the methodological quality of published systematic reviews and meta-analyses varies and biased results can be misleading. Therefore, it is important for readers of systematic reviews to critically evaluate the underlying methods, to be able to assess the validity of their findings. This manuscript is part of a methods series of the Wiener Medizinische Wochenschrift. It summarizes the methodological hallmarks of systematic reviews and meta-analyses to provide readers with the methodological background necessary to critically evaluate systematic reviews and meta-analyses.SummaryOver the past years, systematic reviews and meta-analyses have led to significant changes in clinical medicine and health policy. To date, they can be viewed as the most objective instruments to answer clinical as well health policy questions. In addition, systematic reviews are an important tool to synthesize the enormous amount of new medical knowledge into a manageable format. Nevertheless, the methodological quality of published systematic reviews and meta-analyses varies and biased results can be misleading. Therefore, it is important for readers of systematic reviews to critically evaluate the underlying methods, to be able to assess the validity of their findings. This manuscript is part of a methods series of the Wiener Medizinische Wochenschrift. It summarizes the methodological hallmarks of systematic reviews and meta-analyses to provide readers with the methodological background necessary to critically evaluate systematic reviews and meta-analyses.ZusammenfassungSystematische Übersichtsarbeiten und Meta-Analysen haben in den letzten Jahren zu wesentlichen Veränderungen in der klinischen Medizin und der Gesundheitspolitik geführt. Sie werden heute als das objektivste Instrument zur Beantwortung klinischer und versorgungspolitischer Fragestellungen gesehen. Systematische Übersichtsarbeiten dienen jedoch auch als Instrument, um das enorme Ausmaß an neu entstehendem medizinischem Wissen in ein bewältigbares Format zusammenzufassen. Die methodische Qualität publizierter systematischer Übersichtsarbeiten ist jedoch unterschiedlich. Eine kritische Evaluierung der Methoden ist daher immer wesentlich, um die Aussagekraft von Resultaten beurteilen zu können. Dieser Artikel ist Teil eine Methoden Serie der Wiener Medizinischen Wochenschrift. Er fasst die wesentlichsten methodischen Aspekte von systematischen Übersichtsarbeiten und Meta-Analysen zusammen und bietet dadurch Lesern den methodischen Hintergrund um Resultate von systematischen Übersichtsarbeiten und Meta-Analysen kritisch evaluieren zu können.