Integration of health technology assessment recommendations into organizational and clinical practice: A case study in Catalonia

OBJECTIVES: Evaluating the impact of recommendations based upon health technology assessment (HTA) represents a challenge for both HTA agencies and healthcare policy makers. This research sought to understand factors affecting the uptake of HTA recommendations to support decision making with respect to the introduction of three health technologies. METHODS: Using a multidimensional framework, based upon a combination of theoretical models, a case study was conducted. A total of twenty-eight semistructured interviews were done with physicians from fifteen hospitals and other stakeholders in Catalonia. Interview content was analyzed iteratively and classified according to theoretical dimensions and contextual factors. RESULTS: At the sociopolitical level, factors related to the organization and financing of the health system were found to affect the utilization of HTA recommendations. At the healthcare organization level, existing collaborations between the hospital and the HTA agency favored the integration of recommendations into practices. Formalism in the organization also influenced the utilization of HTA recommendations. At the professional level, the high degree of autonomy of specialists, the importance of peers and collegial control, and the definition of professional roles and responsibilities influenced physicians' willingness to integrate HTA recommendations into their practice. CONCLUSIONS: This study offers a comprehensive framework to understand the complex dynamics that affect adoption of health technologies in organizational and professional practices. The findings suggest some avenues to promote the integration of HTA recommendations into practices and, thus, increase the utilization of scientific evidence to support decision making in health care.     

Joint project of the International Network of Agencies for Health Technology Assessment--Part 2: Managing the diffusion of positron emission tomography with health technology assessment

OBJECTIVES: Since 1997, members of the International Network of Agencies for Health Technology Assessment (INAHTA) have collaborated on a Joint Project to track the diffusion, evaluation, and clinical policy of positron emission tomography (PET). Part 2 of this updated Joint Project report summarizes HTA-based strategies for directing the clinical use of PET and a discussion on the value of HTA in managing the diffusion of high cost diagnostic technologies, which were presented at an INAHTA-sponsored workshop at the Health Technology Assessment International Annual Meeting in 2004 on strategies for managing high cost diagnostic technologies. METHODS: A summary of the workshop proceedings is presented. CONCLUSIONS: Sharing assessment work, universal agreement in assessment conclusions, stakeholder input, and modeling techniques help manage the uncertainty in the evidence base while targeting clinical use of PET toward the most promising indications. Emphasis on HTA findings, linkage between financing of clinical PET and outcome evaluation, and targeted dissemination of scientific findings empower providers to reduce unnecessary utilization and contain costs within a quality improvement framework. Above all, a trustworthy source of HTA information and a process that is conducive to using scientific evidence as the basis for decision making are essential for managing the diffusion of complex and costly diagnostic technologies in patient care.     

Prioritizing investments in health technology assessment. Can we assess potential value for money?

OBJECTIVE: The objective was to develop an economic prioritization model to assist those involved in the selection and prioritization of health technology assessment topics and commissioning of HTA projects. METHODS: The model used decision analytic techniques to estimate the expected costs and benefits of the health care interventions that were the focus of the HTA question(s) considered by the NHS Health Technology Assessment Programme in England. Initial estimation of the value for money of HTA was conducted for several topics considered in 1997 and 1998. RESULTS: The results indicate that, using information routinely available in the literature and from the vignettes, it was not possible to estimate the absolute value of HTA with any certainty for this stage of the prioritization process. Overall, the results were uncertain for 65% of the HTA questions or topics analyzed. The relative costs of the interventions or technologies compared to existing costs of care and likely levels of utilization were critical factors in most of the analyses. The probability that the technology was effective with the HTA and the impact of the HTA on utilization rates were also key determinants of expected costs and benefits. CONCLUSIONS: The main conclusion was that it is feasible to conduct ex ante assessments of the value for money of HTA for specific topics. However, substantial work is required to ensure that the methods used are valid, reliable, consistent, and an efficient use of valuable research time.     

Health technology assessment in Europe. Improving clarity and performance

This paper discusses the challenges facing health technology assessment (HTA) in Europe, based on an explicit analysis of the characteristics of an "optimal" HTA system. It has three objectives: a) to elaborate an explicit system of policy goals and the characteristics of an optimal HTA system that facilitates the achievement of these goals; b) to identify the general institutional incentive barriers (government and market failures) that prevent the attainment of an optimal HTA system in Europe; and c) to argue that evaluation of the implications of health technologies for equity and inequality in health is an essential part of this optimal system and a considerable challenge for HTA decision makers, especially as national governments realign policy toward equity goals.     

Gesundheitsökonomie und HTA

For a comprehensive health technology assessment (HTA), health economic studies are analysed as well as medical studies. Significance and effects of HTA are rather different in European countries. In Germany HTA is conducted by two official agencies: DIMDI and IQWiG. While DIMDI requires health economic assessments, IQWiG is prohibited from considering economic aspects by law (pure assessment of benefits). For the health economic assessment in HTA reports mainly secondary scientific evidence is exploited, i.e. primarily cost effectiveness and cost utility analyses. The study perspective, the study alternatives and the modelling methods are of great importance for the evaluation and have to be justified in depth. The cost effectiveness ratio and the budget impact are the most important results of the health economic assessment, which is the basis for the appraisal by the health care authorities. For this decision medical, utilitarian or other aspects like the avoidance of unwanted distribution effects are considered. On the other hand often only a few studies are available for the decision making when the appraisal has to be done. This problem might be less relevant in the near future as the number of HTAs and the number of health economic evaluations increases.     

Mobilising modern facts: health technology assessment and the politics of evidence

Conventional models of ‘evidence’ for clinical practice focus on the role of randomised controlled clinical trials and systematic reviews as technologies that promote a specific model of rigour and analytic accountability. The assumption that runs through the disciplinary field of health technology assessment (HTA), for example, is that the quantification of evidence about cost and clinical effectiveness is central to rational policy‐making and healthcare provision. But what are the conditions in which such knowledge is mediated into decision‐making contexts, and how is it understood and used when it gets there? This paper addresses these questions by examining a series of meetings and seminars attended by senior clinical researchers, social care and health service managers in the UK between 1998–2004, and sessions of the House of Commons Health Committee held in 2001 and 2005. These provide contexts in which questions about the value and utility of evidence produced within the frame of HTA were explored in relation to parallel questions about the design, evaluation and implementation of telemedicine and telecare systems. The paper points to the ways that evidence generated in the normative frame of HTA was increasingly seen as one‐dimensional and medicalised knowledge that failed to respond to the contingencies of everyday practice in health and social care settings.     

Quality assurance and quality improvement in medical practice - Part 2. Evidence-based medicine

For assuring and improving quality of healthcare, everyday medical practice should be based on appropriate scientific evidence and results of health technology assessment. Evidence-based medicine is the integration of clinical expertise, patient values, and the best evidence into the decision making process for patient care, when health technologies are used. On one hand health technologies which proved to be effective should be available for all patients, on the other hand, because of the limited financial resources of the health care system, they should be cost-effective, not to spend on interventions proved to be ineffective or even harmful. For effective implementation of evidence-based practice, development of more clinical guidelines, that contain explicit recommendations, and improvement of quality approach are necessary in Hungary.     

患者偏好证据应用于卫生技术评估的价值、方法及挑战

当前,越来越多的国际卫生技术评估机构倡导在卫生技术评估(Health Technology Assessment,HTA)过程中整合患者偏好证据,从而使卫生决策的制定更加公开、透明和以患者为中心。HTA在我国已成为临床应用、医保准入以及定价等决策活动的关键手段,但关于患者偏好应用于HTA的价值以及如何在HTA中整合患者偏好证据等方面的研究还非常匮乏。本文从患者偏好应用于HTA的价值、现有途径与方法以及存在的挑战等维度进行分析总结,以期推动我国HTA科学应用患者偏好证据,为临床及卫生管理决策的制定提供更加综合、全面的证据信息。     

Differences between systematic reviews and health technology assessments: a trade-off between the ideals of scientific rigor and the realities of policy making.

OBJECTIVES: To elucidate important differences between a health technology assessment (HTA) and a systematic review, using an HTA of positron emission tomography (PET) as an example. METHODS: Interviews with seventeen individuals who were authors or users of the PET HTA. RESULTS: Those interviewed identified seven areas in which HTAs often differ from traditional systematic reviews: (i) methodological standards (HTAs may include literature of relatively poor methodological quality if a topic is of importance to decision-makers), (ii) replication of previous studies (relatively common for HTAs but not systematic reviews), (iii) choice of topics (more policy oriented for HTAs, while systematic reviews tend to be driven by researcher interest), (iv) inclusion of content experts and policy-makers as authors (policy-makers more likely to be included in HTAs, although there are potential conflicts of interest), (v) inclusion of economic evaluations (more often with HTAs, although economic evaluations based upon poor clinical data may not be useful), (vi) making policy recommendations (more likely with HTAs, although this must be done with caution), and (vii) dissemination of the report (more often actively done for HTAs). CONCLUSIONS: This case study of an HTA of PET scanning confirms that HTAs are a bridge between science and policy and require a balance between the ideals of scientific rigor and the realities of policy making.     

Doing mini-health technology assessments in hospitals: a new concept of decision support in health care?

OBJECTIVES: The purpose of this project was to evaluate local decision support tools used in the Danish hospital sector from a theoretical and an empirical point of view. METHODS: The use of local decision support was evaluated through questionnaires sent to all county health directors, all hospital managers, and all heads of clinical departments in cardiology, orthopedic surgery, and intensive care. In addition, respondents were asked to submit whatever decision support tools they were using (including mini-HTAs, other forms or checklists, and special procedures for decision making concerning new health technologies). A theoretical analysis of the decision support tools (decision theory) was performed as well as a comparison with the business case method used in private companies. Finally, the Danish mini-HTA was compared with foreign production and use of HTA and HTA-like assessments as local decision support. RESULTS: The response rate was high (87 percent, 94 percent, 85 percent, respectively). We collected sixty different forms (of which forty-nine were mini-HTAs) and twenty variants of written procedures. We found theoretical and empirical evidence that local involvement in the process of making the HTA could be important for the use of the results from the HTA and for the process of implementing the new technology. CONCLUSIONS: Doing mini-HTA in hospitals seems to balance the need for quality and depth with the limited time and resources for assessment.     

Are economic evaluations and health technology assessments increasingly demanded in times of rationing health services? The case of the Argentine financial crisis

OBJECTIVES: After 4 years of deepening recession, Argentina's economy plummeted after default in 2002. This crisis critically affected health expenditures and triggered acute rationing. Our objective was to explore health decision-makers' knowledge and attitudes about economic evaluations (EE) and whether health technology assessment (HTA) were increasingly used for decision making. METHODS: A qualitative design based on semistructured interviews and focus groups was used to explore how decision makers belonging to different health sectors implement resource allocation decisions. RESULTS: Informants were mostly unaware of EE. The most important criteria mentioned to adopt a treatment were evidence of effectiveness, social/stakeholder demand, or resource availability. Despite general positive attitudes about EE, knowledge was rather limited. Although cost considerations were widely accepted by purchasers and managers, clinicians argued about these issues as interfering with the doctor-patient relationship. Other important perceived barriers to HTA use were lack of confidence in the transferability of studies conducted in developed countries and institutional fragmentation of the Argentine healthcare system. The new macroeconomic context was cited as a justification of implicit rationing measures. Although explicit priority setting was implemented by many purchasers and managers, HTA was not used to improve technical and/or allocative efficiency. CONCLUSIONS: The crisis seems to be a strong incentive to extend the use of HTA in Argentina, provided decision makers are aware as well as involved in the generation of local studies.     

Health technology assessment in four countries: response from political science

Four studies, each on health technology assessment (HTA) in a different country, are presented in this volume. Conveying differing levels of sensitivity to political aspects of HTA, their storylines are similar in terms of the importance of the institutional structures that produce HTA and mediate its influence on health policy decision making. Regarding the internal politics of HTA, the latter appears to have developed in a relatively depoliticized environment, supported by a dense and varied web of institutional sites for funding, production, and consumption of HTA, buffered from the capricious impacts of electoral politics. Regarding external politics, HTA in all the countries began with relatively politically innocuous studies of technologies recognized to be of major import to national health systems or researcher-initiated studies. However, with increased focus in health systems on explicit determination of health benefits baskets, the role of HTA has become more high profile. This means that political accountability for the entire HTA process will increase. The implication is that future management of HTA programs will require self-conscious attention to the building of institutions capable of handling the delicate process of integrating science and politics in health policy.     

Using health technology assessment to support optimal use of technologies in current practice: the challenge of "disinvestment"

Background: Health systems face rising patient expectations and economic pressures; decision makers seek to enhance efficiency to improve access to appropriate care. There is international interest in the role of HTA to support decisions to optimize use of established technologies, particularly in "disinvesting" from low-benefit uses. Methods: This study summarizes main points from an HTAi Policy Forum meeting on this topic, drawing on presentations, discussions among attendees, and an advance background paper. Results and Conclusions: Optimization involves assessment or re-assessment of a technology, a decision on optimal use, and decision implementation. This may occur within a routine process to improve safety and quality and create "headroom" for new technologies, or ad hoc in response to financial constraints. The term "disinvestment" is not always helpful in describing these processes. HTA contributes to optimization, but there is scope to increase its role in many systems. Stakeholders may have strong views on access to technology, and stakeholder involvement is essential. Optimization faces challenges including loss aversion and entitlement, stakeholder inertia and entrenchment, heterogeneity in patient outcomes, and the need to demonstrate convincingly absence of benefit. While basic HTA principles remain applicable, methodological developments are needed better to support optimization. These include mechanisms for candidate technology identification and prioritization, enhanced collection and analysis of routine data, and clinician engagement. To maximize value to decision makers, HTA should consider implementation strategies and barriers. Improving optimization processes calls for a coordinated approach, and actions are identified for system leaders, HTA and other health organizations, and industry.     

Health technology assessment and clinical decision making: which is the best evidence?

This paper examines the rationality of the concepts underlying evidence-based medicine and health technology assessment (HTA), which are part of a new current aimed at promoting the use of the results of scientific studies for decision making in health care. It describes the different approaches and purposes of this worldwide movement, in relation to clinical decision making, through a summarized set of specific HTA case studies from Catalonia, Spain. The examples illustrate how the systematic process of HTA can help in several types of uncertainties related to clinical decision making.     

Time-trends in health technology assessments: an analysis of developments in composition of international health technology assessments from 1989 to 2002

OBJECTIVES: Health Technology Assessment (HTA) as a method for producing evidence in the health-care sector has been used for more than 25 years but has grown in extent during the past years. The objective of this study is to explore a possible evolution in these HTAs, in type of assessed technologies, in type of assessors, and in its methods. METHODS: A structured literature review was conducted of 433 HTA reports from the period 1989 to 2002 by eleven leading HTA institutions worldwide. The review focused on the methodology used, the assessors, and the assessed technologies and was designed to elucidate general time-trends in the practical application of HTA. RESULTS: The study shows that literature reviews are still the most often used method of assessment and accounts for a relatively stable fraction of assessments. The fraction of economic evaluations shows a slightly decreasing trend in contrast to randomized controlled trials and modeling/evaluations, which are applied more frequently. The data also demonstrate a more frequent use of external partners as assessors and a shift between devices and pharmaceuticals as assessed technologies. CONCLUSIONS: The study shows an increase in the number of HTAs but no major developments in assessment methods used and, therefore, no widespread spillover from the development in research methods in general to the field of HTA methodology.     

Methodology of constructive technology assessment in health care

OBJECTIVES: Technologies in health care are evolving quickly, with new findings in the area of biotechnological and genetic research being published regularly. A health technology assessment (HTA) is often used to answer the question of whether the new technology should be implemented into clinical practice. International evidence confirms that the results of HTA research sometimes have limited impact on practical implementation and on coverage decisions; the study design is commonly based on the paradigm of stability of both the technology and the environment, which is often not the case. Constructive technology assessment (CTA) was first described in the 1980s. In addition to the traditional HTA elements, this approach also takes into account the technology dynamics by emphasizing sociodynamic processes. With a CTA approach, comprehensive assessment can be combined with an intentional influence in a favorable direction to improve quality. METHODS: In this study, the methodological aspects mainly concerning the diagnostic use of CTA are explained. The methodology will be illustrated using the controlled introduction of a new technology, called microarray analysis, into the clinical practice of breast cancer treatment as a case study. Attention is paid to the operationalization of the phases of development and implementation and the research methods most appropriate for CTA. CONCLUSIONS: In addition to HTA, CTA can be used as a complementary approach, especially in technologies that are introduced in an early stage of development in a controlled way.     

Demandas y expectativas de la evaluación de tecnologías sanitarias en Galicia. Análisis cualitativo desde la perspectiva de decisores y clínicos

Objective

To explore perceptions of the use of health technology assessment (HTA) in the Galician public health system, identify opinions on the usefulness of the products and services developed by the Galician Health Technology Assessment Agency (avalia-t), and determine the barriers and facilitators to the transfer of results to clinical practice.

Method

We performed a qualitative study based on in-depth semi-structured interviews of 20 intentionally selected experts (10 health care professionals and 10 hospital decision makers). The interviews were tape recorded and transcribed for inductive thematic analysis.

Results

Interest in HTA activities was high, but most informants considered these activities to be underused as a tool to aid decision making in clinical practice. A series of key factors was identified to guarantee HTA use: greater dissemination of HTA activities and availability of the results, increased involvement and communication among health care professionals in the selection and prioritization of relevant research, contextualization and adaptation of results to the local context, increased organizational support and greater financial resources.

Conclusions

The present study allows end-user? opinions on the utility of the various products/services offered by HTA agencies to be contrasted in order to adapt HTA activity to their needs and requirements. The involvement of health care professionals in all HTA fields is perceived as one of the main lines of action for HTA agencies. Such involvement could be achieved by reinforcing personal contact and increasing feedback to collaborators.     

Framework for describing and classifying decision-making systems using technology assessment to determine the reimbursement of health technologies (fourth hurdle systems)

OBJECTIVES: Australia, Canada, and many European countries now use various forms of health technology assessment (HTA) in decision making regarding the reimbursement of drugs and other health technologies. To achieve a better understanding of the potential for use of HTA in this context, an analytical framework was developed to describe and classify existing fourth hurdle systems. METHODS: Based on a review of published literature, and official documentation, the key aspects of a fourth hurdle system were identified at two levels: policy implementation and individual technology decision. Characteristics of the systems were grouped under four main headings: constitution and governance, objectives, use of evidence and decision processes, and accountability. The comprehensiveness and relevance of this framework was assessed by an independent group of experts in HTA. A pilot study was undertaken, using only published sources, to test the feasibility of obtaining the information needed to complete the framework. RESULTS: The framework was found to be sufficiently broad to encompass all the issues of interest regarding the systems, but the proportion of information available from published sources was variable between sections of the framework and between countries, with average availability of 45 percent. CONCLUSIONS: The analytical framework will help researchers and policy makers in individual countries to understand their own systems and will allow some preliminary sharing of experience between countries. More experience of its application is needed to judge whether it will provide the basis for more formal comparison of systems and whether it will determine their appropriateness for particular decision contexts.     

Priority setting for health technology assessments: a systematic review of current practical approaches

OBJECTIVES: This study sought to identify and compare various practical and current approaches of health technology assessment (HTA) priority setting. METHODS: A literature search was performed across PubMed, MEDLINE, EMBASE, BIOSIS, and Cochrane. Given an earlier review conducted by European agencies (EUR-ASSESS project), the search was limited to literature indexed from 1996 onward. We also searched Web sites of HTA agencies as well as HTAi and ISTAHC conference abstracts. Agency representatives were contacted for information about their priority-setting processes. Reports on practical approaches selected through these sources were identified independently by two reviewers. RESULTS: A total of twelve current priority-setting frameworks from eleven agencies were identified. Ten countries were represented: Canada, Denmark, England, Hungary, Israel, Scotland, Spain, Sweden, The Netherlands, and United States. Fifty-nine unique HTA priority-setting criteria were divided into eleven categories (alternatives; budget impact; clinical impact; controversial nature of proposed technology; disease burden; economic impact; ethical, legal, or psychosocial implications; evidence; interest; timeliness of review; variation in rates of use). Differences across HTA agencies were found regarding procedures for categorizing, scoring, and weighing of policy criteria. CONCLUSIONS: Variability exists in the methods for priority setting of health technology assessment across HTA agencies. Quantitative rating methods and consideration of cost benefit for priority setting were seldom used. These study results will assist HTA agencies that are re-visiting or developing their prioritization methods.     

Analysis of strengths, weaknesses, opportunities, and threats in the development of a health technology assessment program in Turkey

OBJECTIVES: The Turkish healthcare system is currently undergoing reform, and efficient use of resources has become a key factor in determining the allocation of resources. The objective of this study was to analyze strengths, weaknesses, opportunities, and threats (SWOT) in the development of a health technology assessment (HTA) program in Turkey. METHODS: A SWOT analysis was performed using a literature review and interviews with key people in the Turkish Ministry of Health and Ministry of Labor and Social Security. RESULTS: Regarding recent reforms in health care, investments for information network and databank are the strengths, but the traditional "expert-based" decision making, poor availability of data, and poor quality of data could be seen as some of the weaknesses. Another major weakness is lack of general awareness of HTA. Increasing demand for transparency in decision making, demand for evidence, and demand for credibility by decision makers are some of the opportunities, and current healthcare reforms, i.e., restructuring of healthcare and general health insurance, could also be seen as major opportunities. These opportunities unfortunately could be threatened by lack of funding, and resources are challenged by large, recent national investments. CONCLUSIONS: There is a good opportunity for Turkey to use the skills in HTA currently being developed through activities in Europe and the Americas to assist in the development of a much more cost-effective and transparent healthcare system in Turkey.