Health technology assessment: the contribution of qualitative research

The pragmatism in health care has made health technology assessment (HTA) restrict its scope to a particular set of problems, c.q. methods. The "multidisciplinary and comprehensive nature" of HTA, as the concept is presented in certain definitions, is lacking. Health care is also dominated by a positivistic-rationalistic approach of evaluation. In contrast, social studies of evaluations learn that a major difference has to be made between scientific research on (potential) impact of a technology and valuing these effects. In this contribution, we will discuss how the positivistic scientific bias of current HTA practice can be made up with other research traditions. More specifically, we focus on the question of how social scientists and particularly how qualitative research can contribute to HTA, complementary to positivistic studies of evidence and efficacy.     

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.     

Die kritische Rolle wissenschaftlicher Evidenz im Rahmen von Health Technology Assessment

In spite of their different aims, evidence-based medicine (EBM) and health technology assessment (HTA) to some extent use similar methodologies for the assessment of a technology's efficacy. The decision to include only a certain quality of studies in a HTA report usually follows the hierarchy of evidence with different levels of evidence. Problems arise if study evidence is completely lacking or if it is extrapolated or transferred to other healthcare settings. As subjectivity is inevitable when critically appraising the evidence or combining it with other sources of information, HTA decisions should be presented with maximum transparency. Since physicians usually have only limited knowledge of research methodology and read only an average of 20 articles per year, a cooperative approach is required when appraising the evidence for HTA.     

The role of health technology assessment on pharmaceutical reimbursement in selected middle-income countries

ObjectiveMiddle-income countries are often referred to as developing or emerging economies and face multiple challenges of severe financial stresses in their health care sectors, and high disease burden. The objective of this study is to provide an overview of how health technology assessment (HTA) is used and organized in selected middle-income countries and its role in the process of pharmaceutical coverage.MethodsWe selected middle-income countries where HTA activities are evident: Argentina, Brazil, China, Colombia, Israel, Mexico, Philippines, Korea, Taiwan, Thailand, and Turkey. We collected and reviewed relevant information to describe the health care and reimbursement systems and how HTA relates to coverage decision-making of pharmaceuticals. This was supplemented by information from a structured survey among professionals working in public and private health insurance, industry, regulatory authorities, ministries of health, academic units or HTA.ResultsAll countries require market authorization for pharmaceuticals to be sold and most countries have a national plan defining which pharmaceuticals can be reimbursed. However, the use of HTA in reimbursement decisions is still in its early stages with varying levels of HTA guidance implementation.ConclusionsThe study provides evidence of the development of HTA in coverage decision-making in middle-income countries. Increased health care spending and the resulting access to modern technology give a strong impetus to HTA. However, HTA is developing with uneven speed in middle-income countries and many countries are building on the organisational and methodological experience from established HTA agencies.     

Primary data collection in health technology assessment

This study discusses the value of primary data collection as part of health technology assessment (HTA). Primary data collection can help reduce uncertainty in HTA and better inform evidence-based decision making. However, methodological issues such as choosing appropriate study design and practical concerns such as the value of collecting additional information need to be addressed. The authors emphasize the conditions required for successful primary data collection in HTA: experienced researchers, sufficient funding, and coordination among stakeholders, government, and researchers. The authors conclude that, under specific conditions, primary data collection is a worthwhile endeavor in the HTA process.     

The development of health technology assessment

The field of health technology assessment (HTA) is still relatively new, but it has shown remarkable growth over the last decade, having spread first from the United States to Europe, and now to the entire world. HTA seeks to couple evidence with decision-making, and thus has similarities to evidence-based health care and evidence-based policy-making. The early history of HTA, beginning around 1975, reveals a first period of synthesising available evidence-principally that dealing with efficacy and cost-effectiveness of health care interventions-so as to put it in a format helpful to health policy-makers, especially those in national governments. From 1985 or so, the focus of the second period was on seeking more effective links with these policy-makers, particularly in Europe. The most recent period, beginning in the late 1990s, has been increasingly devoted to more effective dissemination and implementation in order to influence administrators and clinicians. While early assessments tended to focus on large, expensive, machine-based technologies, the scope has gradually widened to include smaller technologies, 'softer' technologies (such as counselling), and health care needs. Actual assessments have also taken on broader issues, such as organisational, social, and ethical implications. In the Member States of the European Union (EU), HTA activities are increasingly visible, and almost all now have a national focus for HTA associated with the Ministry of Health or its equivalent. Central and Eastern European countries are also developing HTA activities. Most recently, HTA has been highlighted by health policy documents from the European Commission. It seems likely that HTA will in the future be institutionalised in some form as part of EU activities.     

Das Deutsche Netzwerk Evidenzbasierte Medizin — DNEbM

The German Network for Evidence-based Medicine (DNEbM) was founded in October 2000. A major impetus for the development of evidence-based medicine (EBM) in Germany came in the mid-1990s from the German Cochrane Initiative, which referred to the principles and activities of the international Cochrane Collaboration. The Network's primary mission is to establish a competence and reference centre for all aspects of evidence-based medicine. Central to this mission is to encourage projects that are concerned with scientific and methodological problems, aspects of professional development and the question of how to translate EBM into clinical practice. With currently more than 600 individual members the DNEbM is the most important society concerned with EBM in the German-speaking region in Europe. Until now, the DNEbM has initiated the development of curricula for EBM and health technology assessment (HTA) for undergraduate and continuing medical education. In addition, position papers regarding hot topics such as prostate cancer screening with PSA or registration of randomised controlled trials were published. The Network's HTA section comprises experts from universities, institutes, health care administration and industry. Currently, the HTA section is developing an Internet-based course for users and doers of HTA reports in Germany.     

Health technology assessment in England and Wales

In this study, we describe the current state of the Health Technology Assessment (HTA) system in England and Wales. This system rests on a distinction between assessment and appraisal and has three main strands: researcher-led HTA, the research and development program, and the HTA-NICE (National Institute for Clinical Excellence) process. We outline the pressures for HTA and how it has evolved in the British National Health Service. We discuss how HTA priorities are chosen, how HTA information is collected and assessed, how HTA evidence is used, and we make some observations about its impact. In our discussion, we consider some limitations of the HTA system, its possible divergence from evidence-based health care, its centralization, and some of the key challenges for managing HTA-driven policy. But we remain hopeful that HTA can contribute to better and more explicit decision-making within England and Wales.     

Patient-based health technology assessment: a vision of the future

BACKGROUND: In conjunction with other important movements in contemporary medicine, including evidence-based medicine (EBM), health technology assessment (HTA) has promoted a culture of critical evaluation. Despite this impact, institutional and methodological challenges are associated with HTA. For example, only in recent years has HTA attempted an open dialogue with patients; however, this is normally done by giving them a "seat" at the HTA decision-making table, rather than by more scientific means. OBJECTIVES: The aim of this study was to develop a working definition of patient-based HTA, to identify the current barriers to adopting a patient-based model, and to formulate a vision of how a patient-based HTA could be used to promote patient empowerment and patient-centered care. RESULTS: In the ideal setting, a patient-based HTA would promote patient knowledge by providing access to information and promoting an informed dialogue between patients and their healthcare professionals. To implement a patient-based HTA, the focus must turn to the patient's issues and incorporate each patient's unique perspective and preferences. Processes must change to increase patient participation in all levels of HTA and aim to promote empowered patients who can make informed decisions. CONCLUSIONS: Present-day HTA is broad and has numerous stakeholders, with none so important as the patient. By asking patient-oriented questions in HTA and better involving patients throughout the entire process, we can easily promote patient empowerment, and as such make patients more capable to play a more active role in healthcare decision making.     

Applying research to health care policy and practice: medical and managerial views on effectiveness and the role of research

OBJECTIVES: This study explores the way in which doctors and managers think about the effectiveness of health care interventions and how this shapes the evidence they use to support decision-making. METHODS: Case studies of the introduction of three new medical technologies in nine National Health Service (NHS) hospitals and health authorities. RESULTS: Effectiveness research provides essential evidence on clinical and cost-effectiveness and is used primarily by clinicians and public health doctors for this purpose. However, research fails to provide the 'evidence' required by managerial decision-makers, whose objectives relate as much to the effect of a technology on organisational performance as on patient health and well-being. The evidence used to inform technology adoption decisions reflects the professional role and objectives of different decision-makers. CONCLUSIONS: The assumed relationship between 'research' and 'evidence' for the purpose of promoting effective health care does not take account of the wide range of objectives pursued by different health care decision-makers and the varied sources of 'evidence' they use to support their decisions.     

卫生技术评估国内外研究现状及应用

卫生技术评估（Health technology assessment，HTA）主要评估某项卫生技术的有效性、安全性、经济性和社会影响。它被广泛应用于卫生保健领域和医疗服务系统，其研究成果是卫生决策的重要依据。但HTA在我国的发展时间较短，仍属新领域，本文将对HTA的有关内容做一简要介绍，旨在推广这一新型评估技术的应用。     

“It all depends”: Conceptualizing public involvement in the context of health technology assessment agencies

There have been calls in recent years for greater public involvement in health technology assessment (HTA). Yet the concept of public involvement is poorly articulated and little attention has been paid to the context of HTA agencies. This article investigates how public involvement is conceptualized in the HTA agency environment. Using qualitative concept analysis methods, we reviewed the HTA literature and the websites of HTA agencies and conducted semi-structured interviews with informants in Canada, Denmark, and the United Kingdom. Our analysis reveals that HTA agencies' role as bridges or boundary organizations situated at the frontier of research and policymaking causes the agencies to struggle with the idea of public involvement. The HTA community is concerned with conceptualizing public involvement in such a way as to meet scientific and methodological standards without neglecting its responsibilities to healthcare policymakers. We offer a conceptual tool for analyzing the nature of public involvement across agencies, characterizing different domains, levels of involvement, and types of publics.     

Evaluating health interventions: exploiting the potential

The importance of the evaluation of health care interventions (EHI) including formal health technology assessment (HTA) cannot be over-emphasised, as its results can inform and improve resource allocation decisions in all parts of the health care system, public and private. At present, fragmented and inefficient resource allocation processes are a universal problem and, as a consequence, patients are deprived of care from which they could benefit. Such outcomes are not only inefficient but also unethical. In this paper we focus on HTA, which emphasises the need to link evidence to policy and practice, but our conclusions can be applied to all types of EHI. There is a need for greater use of economic evidence within HTA. Four principle characteristics of HTA are discussed in this paper: types of knowledge and evaluation, and commissioning and knowledge utilisation. Policy-makers must invest in improving research and receptor capacities for producing and using knowledge, improve quality control, and invest in research into dissemination and implementation mechanisms. The potential of HTA is great, and its use has increased, but it remains largely unexploited in most countries.     

德国卫生技术评估决策转化路径及方法探析

德国与我国有着相似医疗保障体系背景,并且已经形成以国家层面三大卫生技术评估(Health Technology Assessment,HTA)机构为主的严谨的HTA管理流程和高效的决策转化路径,是全球基于HTA进行卫生领域循证决策的典型代表。本文通过文献研究和实地调研,分析梳理了德国HTA应用及其决策转化的路径和方法,最终结合我国现阶段HTA决策转化面临的问题和挑战,有针对性地提出了几条促进我国HTA决策转化的启示性建议。     

The evidence-based approach in health policy and health care delivery

Evidence-based approaches are prominent on the national and international agendas for health policy and health research. It is unclear what the implications of this approach are for the production and distribution of health in populations, given the notion of multiple determinants in health. It is equally unclear what kind of barriers there are to the adoption of evidence-based approaches in health care practice. This paper sketches some developments in the way in which health policy is informed by the results from health research. It summarises evidence-based approaches in health at three impact levels: intersectoral assessment, national health care policy, and evidence-based medicine in everyday practice. Consensus is growing on the role of broad and specific health determinants, including health care, as well as on priority setting based on the burden of diseases. In spite of methodological constraints, there is a demand for intersectoral assessments, especially in health sector reform. Initiators of policy changes in other sectors may be held responsible for providing the evidence related to health. There are limited possibilities for priority setting at the national health care policy level. Hence, there is a decentralisation of responsibilities for resource use. Health care providers are encouraged to assume agency roles for both patients and society and asked to promote and deliver effective and efficient health care. Governments will have to design a national framework to facilitate their organisation and legal framework to enhance evidence-based health policy. Treatment guidelines supported by evidence on effectiveness and efficiency will be one essential element in this process. With the increasing number of advocates for the enhancement of population health in the policy arenas, evidence-based approaches provide the information and some of the tools to help with priority setting.     

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.     

Informing, advising, or persuading? An assessment of bone mineral density testing information from consumer health websites

Greater access to web-based information on health-care interventions might result in greater participation by patients in care and self-care decisions, but only improve health outcomes if the indicated actions produce the intended benefits. Unbiased research on benefits and harms of health information can provide a basis for evidence-based patient information systems. OBJECTIVES: To evaluate the quality of the information content on bone-mineral density (BMD) testing posted on consumer health websites (CHWS). METHODS: Five popular engines (Yahoo, MSN, AOL, Lycos, and Go.com) were used to search for patient information on bone densitometry. The fifteen websites that supplied relevant content and were identified by three of the five search engines were selected in order of popularity of the search engine and primacy of placement. Six BMD reports from health technology assessment (HTA) organizations were used as a standard of scientific quality. These were identified from the HTA Database at York University United Kingdom and published between 1996 and 2001. Content was extracted from both document types, and these sets were compared independently by two reviewers. RESULTS: The majority of CHWS identified by popular search engines do not disclose the limited capacity of BMD to discriminate between low-risk individuals and those who will suffer future fractures. CHWS generally present BMD testing as quick, painless, noninvasive, and as being recommended, based on risk factors that are widespread among the general public. BMD testing information is prominently paired on CHWS sites with information on osteoporosis, with an emphasis on "silent disease" and the devastating consequences of advanced disease. Sponsors of CHWS sites are frequently either providers of BMD testing or companion drugs, and consequently in a position of conflict of interest with regard to decisions to undergo BMD testing. HTA organizations have no documented conflict of interest, nor do they invoke emotional arguments. Their approach is to emphasize the effects of testing on populations, on the basis of referenced research findings. CONCLUSIONS: Content analysis demonstrates the omissions and divergence of information on BMD testing available to consumers on the Internet, as compared with HTA reports. The content of HTA reports has undergone rigorous systematic and peer review; therefore, their findings may be useful to consumers. This information is not generally accessible to patients using the most popular Internet search engines. Inaccurate and incomplete information may cause harm by deflecting patients from optimal decisions.     

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.     

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.     

Health technology assessment in Denmark

The Danish healthcare services are mainly provided by public sector institutions. The system is highly decentralized. The state has little direct influence on the provision of healthcare services. State influence is exercised through legislation and budget allocations. The main task of the state is to initiate, coordinate, and advise. Counties, which run the hospitals, also decide on the placement of services. The hospital sector is controlled within the framework of legislation and global budgets. General practitioners occupy a central position in the Danish healthcare sector, acting as gatekeepers to the rest of the system. The system works well, and its structure has resulted in steady costs of health care for a long period. There is no regulatory mechanism in the Danish health services requiring use of health technology assessment (HTA) as a basis for policy decisions, planning, or administrative procedures. However, since the late 1970s a number of comprehensive assessments of health technology have formed the basis for national health policy decisions. In 1997, after years of public criticism of the quality of hospital care and health technologies, and on the basis of a previously developed national HTA strategy, a national institute for HTA (DIHTA) was established. There seems to be a growing awareness of evidence-based healthcare among health professionals and a general acceptance of health economic analyses as a basis for health policy decision making. This progress is coupled with growing regional HTA activity in the health services. HTA seems to have a bright future in Denmark.