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PubMed2004

Quality improvement in an outpatient department for subacute low back pain patients: prospective surveillance by outcome and performance measures in a health technology assessment perspective.

STUDY DESIGN: Prospective cohort study. OBJECTIVES: To develop clinical indicators and standards in an outpatients' department for sub acute low back pain patients. SUMMARY OF BACKGROUND DATA: A systematic quantitative surveillance to assess quality of care was implemented using outcome and performance measures. These measures were developed within the framework of Health Technology Assessment, which comprises the areas of healthcare technology, patient, organization, and economy. METHODS: A multidisciplinary project group defined 1) clinical indicators in terms of outcome and performance measures and 2) the corresponding standards using the available evidence from literature. Observed outcomes were compared with the standards. Associations between process and outcome measures were investigated. RESULTS: A total of 300 patients were included consecutively. In relation to technology, the standards for the field of application were fulfilled (e.g., not too many patients were x-rayed). With respect to effectiveness, the observed rate of patients reaching a 50% cutoff point of improvement of pain and function did not fulfill the standards. In relation to patient aspects, the standards of, for example, proper understanding of patient education and satisfaction, were fulfilled. In relation to organization, nearly one third of the patients were referred later to the department than the recommended 24 weeks. This refer variable showed an association to a reduced chance of scoring "better" or "much better" in "patients global assessment." The chance was reduced by 50% if patients were referred later than 12 weeks after onset of pain. In relation to economy, the cost of gaining a quality adjusted life-year by a course in the department was considerably lower than by comparison with total hip arthroplasty. CONCLUSIONS: Surveillance by clinical indicators in relation to the four areas of health technology assessment provides quantitative information that is meaningful for various stakeholders on important aspects of the quality of care (including consumers), provides a basis for quality improvement, and provides data for analysis of possible important relationships between structure, process, and outcome.

Acute Disease↗
PubMed2001

The science of health technology assessment--the economic perspective.

Economic evaluation is a component of health technology assessment. Methods for economic evaluation began to be developed about 30 years ago. More recently, governments have encouraged the development of methodological and reporting guidelines for economic evaluation in health care with the major focus being placed on pharmaceutical products. There are two aspects of economic evaluations discussed in the present paper: the science of the techniques used and the utility of the resulting evaluations. Although activity is increasing in this area, it is still not clear how useful such 'value for money' evaluations have actually been and how much they have been used. It seems that the 'value for money' of 'value for money' evaluations of pharmaceutical products has yet to be shown.

Canada↗
PubMed1998

The role of pilot studies in the economic evaluation of health technologies.

An increasing number of economic evaluations are being conducted alongside clinical trials. While this practice offers the prospect of collecting comprehensive and accurate cost data, it requires considerable time and effort. In the case of clinical data, key analytic decisions such as which data to collect and sample size are often made with reference to smaller (pilot) trials. However, this approach is not normally followed in the case of economic evaluation. This study was based on a recently completed health technology assessment comparing conventional radiotherapy with continuous hyperfractionated accelerated radiotherapy (CHART) for patients with head and neck cancer or carcinoma of the bronchus. In the full health technology assessment, cost data were available for 526 head and neck patients (314 CHART and 212 conventional therapy) and 286 bronchus patients (175 CHART and 109 conventional therapy). In order to simulate a pilot study, data were extracted for the patients recruited to both trials in the first 3 months. These were then compared with the full data set in order to assess whether such a pilot study would have given useful guidance on: a) the usefulness of undertaking a full study; b) the sample size required; and c) the important resource items for which comprehensive data collection would be required. Pilot studies can be helpful in determining the likely advantages of undertaking full economic evaluations and in identifying important resource items. Therefore, it is important that clinical researchers and research funding bodies create the necessary time window to enable such studies to take place. However, formal sample size calculations are more difficult to perform on limited data, since they also require knowledge of the unit cost (or prices) to be attached to the resource items and the correlation between costs and clinical effects.

Bronchial Neoplasms↗
PubMed2004

Pharmaceutical industry's perspective on health technology assessment.

This article presents the pharmaceutical industry's perspective on health technology assessment (HTA) with specific comments on the HTA systems in England and Wales, France, The Netherlands, and Sweden. The comments are focused on the following main themes: (i) The contributions of the HTA system to overall efficiency in the health-care system, (ii) HTA as a cost-driver for industry, patients, government, and society, and (iii) The various implementation barriers that currently exist for a successful implementation of HTA results.

Cost-Benefit Analysis↗
PubMed1997

Hearing instruments and health technology--an evaluation.

This contribution compares a currently worn hearing instrument (i.e. R-HI) with a programmable multiband full-dynamic range compression behind-the-ear HI (i.e. T-HI), based on subject preference for HI, and, in addition, compares the preference for a linear/ non-linear amplification-mode (i.e. L-mode/C-mode). Finally, it evaluates some health technology aspects related to the devices. N = 34 experienced HI-users at a median age of 72 years (range 22-84) completed the trial, n = 5 being monaurally, and n = 29 being binaurally fitted. The trial comprises an unblinded comparative study of the R-HI and T-HI, in either C-mode or L-mode amplification, and a double-blind crossover study evaluating the C-mode versus the L-mode amplification. The results of the unblinded study showed that 94% (n = 32/34) preferred the T-HI, whereas two subjects preferred their current HI. The double-blind crossover study concerning the preference for the C-mode and L-mode, respectively, in the T-HI, showed that 72% (n = 23/32) had a significant preference for the non-linear amplification, whereas 28% (n = 9/32) preferred the linear amplification. Provided that the price of the T-HI is kept unchanged, a health technology evaluation may imply an estimate of 30 mill. DKR added costs on a national basis, which should be taken into account within the national hearing services.

Adult↗
PubMed2004

Ethical perspectives on health technology assessment.

This study analyses why ethical aspects play a minor role in health technology assessment (HTA) studies, even when comprehensive approaches of technology assessment are advocated. Technology is often regarded as a value-neutral tool. At the same time, bioethics is dominated by an engineering model. Ethical contributions to evaluation of medical technology should go beyond issues of application in clinical practice and focus also on the definition of problems, the demarcation of technical and nontechnical issues, and the morally problematic implications of technologies.

France↗
PubMed2004

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.

Cost-Benefit Analysis↗
PubMed1999

Methodological approaches of health technology assessment.

In this era of evolving health care systems throughout the world, technology remains the substance of health care. Medical informatics comprises a growing contribution to the technologies used in the delivery and management of health care. Diverse, evolving technologies include artificial neural networks, computer-assisted surgery, computer-based patient records, hospital information systems, and more. Decision-makers increasingly demand well-founded information to determine whether or how to develop these technologies, allow them on the market, acquire them, use them, pay for their use, and more. The development and wider use of health technology assessment (HTA) reflects this demand. While HTA offers systematic, well-founded approaches for determining the value of medical informatics technologies, HTA must continue to adapt and refine its methods in response to these evolving technologies. This paper provides a basic overview of HTA principles and methods.

Humans↗
PubMed2006

Bringing 'the public' into health technology assessment and coverage policy decisions: from principles to practice.

Those making health care coverage decisions rely on health technology assessment (HTA) for crucial technical information. But coverage decision-making, and the HTA that informs it, are also inherently political. They involve the values and judgments of a range of stakeholders as well as the public. Moreover, governments are politically accountable for their resource allocation decisions. Canadian policy makers are at an early stage in the design of legitimate mechanisms for the public to contribute to, and to be apprised of, HTA and coverage decisions. As they consider the options, questions arise about whom to involve (e.g., which publics), how to engage them (e.g., through what public involvement or accountability mechanisms), and for what purpose (e.g., to inform the public of decisions and their rationales, or to have the public directly affect those decisions). Often key concepts, such as the difference between public accountability and public participation, are not well articulated or distinguished in these debates. Guidance is needed regarding both rationales and methods for involving the public in HTA and technology coverage decisions. We offer a framework that clearly distinguishes specific roles for the public, and relates them to several layers of policy analysis and policy making where 'the public' may engage in different tasks. The framework offers a menu of choices for policy makers contemplating changes to public involvement, as well as a model that can be used to characterize and analyze different approaches across jurisdictions.

Community Participation↗
PubMed2004

Review of guidelines for good practice in decision-analytic modelling in health technology assessment.

OBJECTIVES: To identify existing guidelines and develop a synthesised guideline plus accompanying checklist. In addition to provide guidance on key theoretical, methodological and practical issues and consider the implications of this research for what might be expected of future decision-analytic models. DATA SOURCES: Electronic databases. REVIEW METHODS: A systematic review of existing good practice guidelines was undertaken to identify and summarise guidelines currently available for assessing the quality of decision-analytic models that have been undertaken for health technology assessment. A synthesised good practice guidance and accompanying checklist was developed. Two specific methods areas in decision modelling were considered. The first method's topic is the identification of parameter estimates from published literature. Parameter searches were developed and piloted using a case-study model. The second topic relates to bias in parameter estimates; that is, how to adjust estimates of treatment effect from observational studies where there are risks of selection bias. A systematic literature review was conducted to identify those studies looking at quantification of bias in parameter estimates and the implication of this bias. RESULTS: Fifteen studies met the inclusion criteria and were reviewed and consolidated into a single set of brief statements of good practice. From this, a checklist was developed and applied to three independent decision-analytic models. Although the checklist provided excellent guidance on some key issues for model evaluation, it was too general to pick up on the specific nuances of each model. The searches that were developed helped to identify important data for inclusion in the model. However, the quality of life searches proved to be problematic: the published search filters did not focus on those measures specific to cost-effectiveness analysis and although the strategies developed as part of this project were more successful few data were found. Of the 11 studies meeting the criteria on the effect of selection bias, five concluded that a non-randomised trial design is associated with bias and six studies found 'similar' estimates of treatment effects from observational studies or non-randomised clinical trials and randomised controlled trials (RCTs). One purpose of developing the synthesised guideline and checklist was to provide a framework for critical appraisal by the various parties involved in the health technology assessment process. First, the guideline and checklist can be used by groups that are reviewing other analysts' models and, secondly, the guideline and checklist could be used by the various analysts as they develop their models (to use it as a check on how they are developing and reporting their analyses). The Expert Advisory Group (EAG) that was convened to discuss the potential role of the guidance and checklist felt that, in general, the guidance and checklist would be a useful tool, although the checklist is not meant to be used exclusively to determine a model's quality, and so should not be used as a substitute for critical appraisal. CONCLUSIONS: The review of current guidelines showed that although authors may provide a consistent message regarding some aspects of modelling, in other areas conflicting attributes are presented in different guidelines. In general, the checklist appears to perform well, in terms of identifying those aspects of the model that should be of particular concern to the reader. The checklist cannot, however, provide answers to the appropriateness of the model structure and structural assumptions, as these may be seen as a general problem with generic checklists and do not reflect any shortcoming with the synthesised guidance and checklist developed here. The assessment of the checklist, as well as feedback from the EAG, indicated the importance of its use in conjunction with a more general checklist or guidelines on economic evaluation. Further methods research into the following areas would be valuable: the quantification of selection bias in non-controlled studies and in controlled observational studies; the level of bias in the different non-RCT study designs; a comparison of results from RCTs with those from other non-randomised studies; assessment of the strengths and weaknesses of alternative ways to adjust for bias in a decision model; and how to prioritise searching for parameter estimates.

Benchmarking↗
PubMed1980

The design and use of appropriate health technologies for developing countries.

Health care in developing countries is discussed in terms of the administrative systems, medical manpower and technologies which are most appropriate to the economic and cultural environment in which they will be used. Appropriate technology must be preceded by appropriate research and development and those involved in the training of overseas students should critically examine the relevance of the course to the needs of the students.

Biomedical Engineering↗
PubMed2006

Expanding the scientific basis of health technology assessment: a research agenda for the next decade.

OBJECTIVES: The complexity of health technology assessment (HTA) has increased, in part because of its evolution through three distinct phases: the machine, the clinical outcomes, and the delivery models. However, the theoretical foundation for the field remains underdeveloped. METHODS: It is high time for HTA to bring together aspects of conceptual and theoretical works from other fields to strengthen the foundation of HTA. RESULTS: Many challenges await the further development of HTA. They can be captured around three research themes: adapting HTA to an evolving analysis object; translating HTA results into policy, management, and practice decisions; and evaluating organizational models of HTA. CONCLUSIONS: Consolidating the scientific basis of HTA is essential if we are to succeed in increasing the relevance of HTA in some of the most challenging health-related decisions that we will make as individuals and societies.

Diffusion of Innovation↗
PubMed2004

Improving population health or the population itself? Health technology assessment and our genetic future.

The province of British Columbia (BC), Canada is developing its first population-wide prenatal genetic screening program, known as triple-marker screening (TMS). TMS, initiated with a simple blood test, is most commonly used to screen for fetuses with the chromosomal abnormality known as Down syndrome or neural tube disorders. Women testing TMS-positive are offered diagnostic amniocentesis and, if the diagnosis is confirmed, selective second-trimester abortion. The project described in this study was initiated to address the broad range of issues arising from this testing technology and provides an example of the new type of health technology assessment (HTA) contribution emerging (and likely to become increasing necessary) in health policy development. With the advent of prenatal genetic screening programs, would-be parents gain the promise of identifying target conditions and, hence, the option of selective abortion of affected fetuses. There is considerable awareness that these developments pose challenges in every dimension (ethical, political, economic, and clinical) of the health-care environment. In the effort to construct an appropriate prenatal screening policy, therefore, administrators have understandably sought guidance from within the field of HTA. The report authors concluded that, within the restricted path open to it, the role of government is relatively clear. It has the responsibility to maintain equal access to prenatal testing, as to any other health service. It should also require maintenance of medical standards and evaluation of program performance. At the same time, policy-makers need actively to support those individuals born with disabilities and their families.

British Columbia↗
PubMed2006

[Anthroposophic medicine: health technology assessment report - short version].

BACKGROUND AND OBJECTIVE: The aim of this Health Technology Assessment Report was to analyse the current situation, efficacy, effectiveness, safety, utilization, and costs of Anthroposophic Medicine (AM) with special emphasis on everyday practice. DESIGN: Systematic review. MATERIAL AND METHODS: Search of 20 databases, reference lists and expert consultations. Criteriabased analysis was performed to assess methodological quality and external validity of the studies. RESULTS: AM is a complementary medical system that extends conventional medicine and provides specific pharmacological and non-pharmacological treatments. It covers all areas of medicine. 178 clinical trials on efficacy and effectiveness were identified: 17 RCTs, 21 prospective and 43 retrospective NRCTs, 50 prospective and 47 retrospective cohort studies/case-series without control groups. They investigated a wide range of AM-treatments in a variety of diseases, 90 x mistletoe in cancer. 170 trials had a positive result for AM. Methodological quality differed substantially; some studies showed major limitations, others were reasonably well conducted. Trials of better quality still showed a positive result. External validity was usually high. Side effects or other risks are rare. AM-patients are well educated, often female, aged 30-50 years, or children. The few economic investigations found less or equal costs in AM because of reduced hospital admissions and less prescriptions of medications. CONCLUSION: Trials of varying design and quality in a variety of diseases predominantly describe good clinical outcome for AM, little side effects, high satisfaction of patients and presumably slightly less costs. More research and more methodological expertise and infrastructure are desirable.

Adult↗
PubMed2006

[The critical role of research evidence in the framework of 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.

Biomedical Technology↗
PubMed2000

Health technology assessment in Belgium.

The Belgian healthcare system has a Bismarck-type compulsory health insurance, covering almost the entire population, combined with private provision of care. Providers are public health services, independent pharmacists, independent ambulatory care professionals, and hospitals and geriatric care facilities. Healthcare responsibilities are shared between the national Ministries of Public Health and Social Affairs, and the Dutch-, French-, and German-speaking Community Ministries of Health. The national ministries are responsible for sickness and disability insurance, financing, determination of accreditation criteria for hospitals and heavy medical care units, and construction of new hospitals. The six sickness and disability insurance funds are responsible for reimbursing health service benefits and paying disability benefits. The system's strength is that care is highly accessible and responsive to patients. However, the healthcare system's size remained relatively uncontrolled until recently, there is an excess supply of certain types of care, and there is a large number of small hospitals. The national government created a legal framework to modernize the insurance system to control budgetary deficits. Measures for reducing healthcare expenditures include regulating healthcare supply, healthcare evaluation, medical practice organization, and hospital budgets. The need to control healthcare facilities and quality of care in hospitals led to formal procedures for opening hospitals, acquiring expensive medical equipment, and developing highly specialized services. Reforms in payment and regulation are being considered. Health technology assessment (HTA) has played little part in the reforms so far. Belgium has no formal national program for HTA. The future of HTA in Belgium depends on a changing perception by providers and policy makers that health care needs a stronger scientific base.

Belgium↗
PubMed2000

The concept of health technology assessment. Views of applicants to funding of HTA projects.

OBJECTIVE: The purpose of this study is to analyze the perception of the content of health technology assessment (HTA) among health professionals applying for a state grant of DKK 10 million. METHODS: A total of 113 applications were received and analyzed. When conducting the analysis, it was assumed that the applicants' maximum five-page project description would reflect: a) the applicants' perception of what an HTA is; b) how the assessment was to be conducted; and c) what the results were going to be used for. RESULTS: More than 40% of all applications focused on treatment; in 51% only one or two professional groups were to be involved (thus interdisciplinarity was questionable); only 22% of the HTA cases were intended to form the basis for political/administrative decisions; in general, the HTAs were planned far less comprehensively than was relevant; 76% of the projects did not include a formal synthesis phase; 41% intended to use diffusion as the only method for publication of the HTA result. CONCLUSIONS: The analysis reveals several areas where DIHTA has to make an effort in order to secure that HTA in fact constitutes a comprehensive and well-documented basis for decision making. These areas concern the following topics: multidisciplinarity, the objective of HTA, comprehensiveness, the synthesis phase, and publication and utilization of the HTA result.

Denmark↗