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PubMed2004

A consumer involvement model for health technology assessment in Canada.

Similar to other health policy initiatives, there is a growing movement to involve consumers in decisions affecting their treatment options. Access to treatments can be impacted by decisions made during a health technology assessment (HTA), i.e., the rigorous assessment of medical interventions such as drugs, vaccines, devices, materials, medical and surgical procedures and systems. The purpose of this paper was to empirically assess the interest and potential mechanisms for consumer involvement in HTA by identifying what health consumer organizations consider meaningful involvement, examining current practices internationally and developing a model for involvement based on identified priorities and needs. Canadian health consumer groups representing the largest disease or illness conditions reported a desire for involvement in HTA and provided feedback on mechanisms for facilitating their involvement.

Biomedical Technology↗
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↗
PubMed2006

Is technological change in medicine always worth it? The case of acute myocardial infarction.

We examine Medicare costs and survival gains for acute myocardial infarction (AMI) during 1986-2002. As David Cutler and Mark McClellan did in earlier work, we find that overall gains in post-AMI survival more than justified the increases in costs during this period. Since 1996, however, survival gains have stagnated, while spending has continued to increase. We also consider changes in spending and outcomes at the regional level. Regions experiencing the largest spending gains were not those realizing the greatest improvements in survival. Factors yielding the greatest benefits to health were not the factors that drove up costs, and vice versa.

Acute Disease↗
PubMed1999

A modular micromachined high-density connector system for biomedical applications.

This paper presents a high-density, modular, low-profile, small, and removable connector system developed using micromachining technologies for biomedical applications. This system consists of a silicon or polyimide electrode with one end in contact with the biological tissue and its back-end supported in a titanium base (12.5 mm in diameter and 2.5 mm in height) that is fixed on the test subject. An external glass substrate (6 x 6 x 0.75 mm3), which supports a flexible polyimide diaphragm and CMOS buffers, is attached to the titanium base whenever electrical contact is required. The polyimide flexible diaphragm contains high-density gold electroplated pads (32 pads, each having an area of 100 x 100 micron 2 and separated by 150 microns) which match similar pads on the electrode back-end. When vacuum is applied between the two, the polyimide diaphragm deflects and the corresponding gold pads touch, therefore, establishing electrical connection. In vitro electrical tests in saline solution have been performed on a 32-site connector system demonstrating < 5 omega contact resistance, which remained stable after 70 connections, and -55 dB crosstalk at 1 kHz between adjacent channels. In vivo experiments have also confirmed the establishment of multiple contacts and have produced simultaneous biopotential recordings from the guinea pig occipital cortex.

Animals↗
PubMed2006

[Epidemiological studies in the HTA evaluation process].

Results of epidemiological studies should be considered as part of the available evidence when evaluating drug treatment benefits in health technology assessment (HTA). Pharmaco-epidemiological databases can provide a broader understanding of the effectiveness of drugs in populations that are frequently underrepresented in clinical trials. Such databases are also useful to investigate drug safety with regard to socio-demographic and medical care-related indicators and hereby contribute to an optimal and targeted pharmacological therapy. Using examples from pharmaco-epidemiological asthma studies, the present article discusses associated difficulties in interpreting database results against the background of various sources of bias and proposes possibilities for integrating observational data into the HTA evaluation process. Researchers are challenged to engage in considerable efforts to develop a standardized inventory of epidemiological methods, e.g. for the pooled analysis of epidemiological data.

Biomedical Technology↗
PubMed2006

[The role of HTA in German health care. Do we need impact objectives?].

Like other health technologies, HTA should be judged on the quality and size of its effects. However, it is only in recent years that this aspect has received increased attention. A comprehensive theoretical analysis is still missing. In this article national and international studies on the influence of HTA reports are presented. On the basis of theoretical models, the thesis is developed that the potential of HTA reports is much more extensive and complex than has been generally assumed. In order to make use of this potential, a stepwise procedure is proposed, comprising the involvement of the groups concerned, the explicit inclusion of impact objectives in all HTA reports, and the subsequent evaluation of the effects produced. This procedure is illustrated by the example of one HTA topic.

Biomedical Technology↗
PubMed2002

[More care for a limited budget; a case for a better use of the efficiency criteria].

A systematic consideration of the cost-effectiveness in decisions concerning the financing and implementation of healthcare technologies would contribute to the efficiency of the Dutch healthcare system. This consideration applies to the initial decision to finance a project, the periodic testing of this on the basis of practice data and the policy to promote a cost-effective approach in daily practice (via practice guidelines). Bearing in mind that the government has decided to allocate few additional resources to healthcare, it should undertake measures to ensure the systematic use of such information in these steps. The National Institute for Clinical Excellence (NICE) in the United Kingdom can serve as an example, where broadly supported guidelines are drawn up with systematic attention for the cost-effectiveness and the implications for healthcare. Within this context the question arises as to whether a Dutch variant of NICE is needed.

Biomedical Technology↗
PubMed2000

Bayesian methods in health technology assessment: a review.

BACKGROUND: Bayesian methods may be defined as the explicit quantitative use of external evidence in the design, monitoring, analysis, interpretation and reporting of a health technology assessment. In outline, the methods involve formal combination through the use of Bayes's theorem of: 1. a prior distribution or belief about the value of a quantity of interest (for example, a treatment effect) based on evidence not derived from the study under analysis, with 2. a summary of the information concerning the same quantity available from the data collected in the study (known as the likelihood), to yield 3. an updated or posterior distribution of the quantity of interest. These methods thus directly address the question of how new evidence should change what we currently believe. They extend naturally into making predictions, synthesising evidence from multiple sources, and designing studies: in addition, if we are willing to quantify the value of different consequences as a 'loss function', Bayesian methods extend into a full decision-theoretic approach to study design, monitoring and eventual policy decision-making. Nonetheless, Bayesian methods are a controversial topic in that they may involve the explicit use of subjective judgements in what is conventionally supposed to be a rigorous scientific exercise. OBJECTIVES: This report is intended to provide: 1. a brief review of the essential ideas of Bayesian analysis 2. a full structured review of applications of Bayesian methods to randomised controlled trials, observational studies, and the synthesis of evidence, in a form which should be reasonably straightforward to update 3. a critical commentary on similarities and differences between Bayesian and conventional approaches 4. criteria for assessing the reporting of a Bayesian analysis 5. a comprehensive list of published 'three-star' examples, in which a proper prior distribution has been used for the quantity of primary interest 6. tutorial case studies of a variety of types 7. recommendations on how Bayesian methods and approaches may be assimilated into health technology assessments in a variety of contexts and by a variety of participants in the research process. METHODS: The BIDS ISI database was searched using the terms 'Bayes' or 'Bayesian'. This yielded almost 4000 papers published in the period 1990-98. All resultant abstracts were reviewed for relevance to health technology assessment; about 250 were so identified, and used as the basis for forward and backward searches. In addition EMBASE and MEDLINE databases were searched, along with websites of prominent authors, and available personal collections of references, finally yielding nearly 500 relevant references. A comprehensive review of all references describing use of 'proper' Bayesian methods in health technology assessment (those which update an informative prior distribution through the use of Bayes's theorem) has been attempted, and around 30 such papers are reported in structured form. There has been very limited use of proper Bayesian methods in practice, and relevant studies appear to be relatively easily identified. RESULTS: Bayesian methods in the health technology assessment context 1. Different contexts may demand different statistical approaches. Prior opinions are most valuable when the assessment forms part of a series of similar studies. A decision-theoretic approach may be appropriate where the consequences of a study are reasonably predictable. 2. The prior distribution is important and not unique, and so a range of options should be examined in a sensitivity analysis. Bayesian methods are best seen as a transformation from initial to final opinion, rather than providing a single 'correct' inference. 3. The use of a prior is based on judgement, and hence a degree of subjectivity cannot be avoided. However, subjective priors tend to show predictable biases, and archetypal priors may be useful for identifying a reasonable range of prior opinion.

Bayes Theorem↗
PubMed2003

Instrumental colonisation in modern medicine.

Stethoscopes, x-rays and other medical technologies are two-edged swords. They make medical treatment and diagnosis more accurate and effective, but do at the same time reveal our perceptual inadequacy. By transcending our senses, these technologies reveal that we can be seriously diseased without experiencing any symptoms at all. This situation has changed our attitude towards our relations and ourselves. The situation can be analysed using Jürgen Habermas' conception of "systems colonisation of the lifeworld." Medical technologies colonise our lifeworld. They change the way we think and act. They make us all accept that we can become patients almost any minute, even if we feel perfectly healthy. Sense transcending technologies turn us all into proto-patient.

Biomedical Technology↗
PubMed2005

Use of evidence in decision models: an appraisal of health technology assessments in the UK since 1997.

OBJECTIVES: To review the sources and quality of evidence used in the development of economic decision models in health technology assessments (HTAs). METHODS: All economic decision models developed as part of the NHS Research and Development HTA Programme between 1997 and 2003 were reviewed. Quality of evidence was assessed using a hierarchy of data sources developed for economic analyses. RESULTS: Decision models are parameterized using diverse sources of evidence (e.g. randomized controlled trials, observational studies, expert opinion). Evidence on the main clinical effect was mostly identified and quality assessed as part of the companion systematic review/meta-analysis of the HTA and therefore reported in a transparent and reproducible way. For the other model inputs (i.e. adverse events, baseline clinical data, resource use and utilities), the search strategies for identifying relevant evidence were rarely made explicit and in a number of reports the sources of specific evidence were unclear due to poor reporting. CONCLUSIONS: A more formal and replicable approach to identification and assessment of quality of model inputs is required to reduce the 'black box' nature of decision models, and lead to less scepticism regarding model outputs.

Biomedical Technology↗
PubMed2006

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.

Australia↗
PubMedDate not supplied

[Health policy and occupational health: tools and methods to assure quality and appropriateness of interventions].

BACKGROUND: Although all health care organizations and professionals are encouraged to follow the explicit aim of reducing the burden of illness, accidents and disability, there is increasing pressure on health professionals to ensure that the practice be based on a quality standard and on evidence of appropriateness. OBJECTIVES AND METHODS: The paper aims to focus on both the concept and dimensions of appropriateness (a complex issue with various dimensions and definitions) and on the different research and practice models aimed at search, analysis and synthesis of the best available evidence to be applied in the decision process of health and medical practice. Literature analysis has been carried out to find available tools and methods to identify, implement and monitor the evidence of efficacy in health care systems and services. RESULTS: Most definitions of appropriateness address a number of requirements. An appropriate practice should be effective (based on sound evidence); efficient (providing that cost is considered) and consistent with the ethical principles and preferences of the relevant individual, community or society. Appropriateness is considered as the next frontier in the development of health care research: there is still limited knowledge, awareness, or research on this aspect. Health Technology Assessment consists of a multidisciplinary activity based on the systematic examination of technical performance, safety, clinical effectiveness and efficiency, including socio-economic, legal and ethical aspects. Evidence Based Medicine originates from an individual perspective and aims at using rigorous criteria to obtain the best available evidence in order to provide efficient interventions. The Clinical Practice Guidelines, based on both evidence and opinions of experts, are intended to assist clinical decisions for health professional and providers for the improvement of professional practices and system efficiency, taking into account local customers, health needs and preferences. CONCLUSIONS: Several models exist for measuring and evaluating the efficacy of health systems and health services. They can be adapted for evaluating and measuring public and occupational health practices. These tools support good practice through quality-standardized interventions aiming at the health protection of communities and individuals. These models, which are presented in a specific framework in which their outcomes and critical factors are evaluated, should be adapted to public and occupational health interventions to satisfy implicit and explicit needs of individuals and populations at risk thus assuring their quality and appropriateness.

Biomedical Technology↗
PubMed2006

[Health economics and 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.

Biomedical Technology↗