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One of these things is not like the others: the idea of precedence in health technology assessment and coverage decisions.

Health plans often deliberate covering technologies with challenging purposes, effects, or costs. They must integrate quantitative evidence (e.g., how well a technology works) with qualitative, normative assessments (e.g., whether it works well enough for a worthwhile purpose). Arguments from analogy and precedent help integrate these criteria and establish standards for their policy application. Examples of arguments are described for three technologies (ICSI, genetic tests, and Viagra). Drawing lessons from law, ethics, philosophy, and the social sciences, a framework is developed for case-based evaluation of new technologies. The decision-making cycle includes (1) taking stock of past decisions and formulating precedents, (2) deciding new cases, and (3) assimilating decisions into the case history and evaluation framework. Each stage requires distinctive decision maker roles, information, and methods.

Canada↗

Health technology assessment and gastroenterology.

Too much clinical practice is based on unproved opinion. Health technology assessment (HTA) encourages critical review of the literature in a particular area, from which an objective assessment can be made so that clinical practice may be more scientifically based. Only a small number of centers undertake this type of work, usually at a national level. We have been able to set up a more local HTA system (the Wessex Development and Evaluation Committee) with links to clinicians and both providers and purchasers of health care within a region of 3 million people. All aspects of medicine may be reviewed and discussed by the committee; 3 examples from within the field of gastroenterology are summarized herein. Active participation of a university-based institute to provide the reviews is essential. A local HTA facility confers a number of advantages.

Cholelithiasis↗

Comparison of conference abstracts and presentations with full-text articles in the health technology assessments of rapidly evolving technologies.

OBJECTIVES: To assess the extent of use of data from conference abstracts and presentations in health technology assessments (HTAs) provided as part of the National Institute for Health and Clinical Excellence (NICE) appraisal process. Also to assess the methodological quality of trials from conference abstracts and presentations, the consistency of reporting major outcomes between these sources and subsequent full-length publications, the effect of inclusion or exclusion of data from these sources on the meta-analysis pooled effect estimates, and the timeliness of availability of data from these sources and full articles in relation to the development of technology assessment reviews (TARs). DATA SOURCES: A survey of seven TAR groups. An audit of published TARs: included all NICE TARs published between January 2000 and October 2004. Case studies of selected TARs. REVIEW METHODS: Analyses of the results of the survey and audit were presented as a descriptive summary and in a tabular format. Sensitivity analyses were carried out to compare the effect of inclusion of data from abstracts and presentations on the meta-analysis pooled effect estimates by including data from both abstracts/presentations and full papers, and data from only full publications, included in the original TAR. These analyses were then compared with meta-analysis of data from trials that have subsequently been published in full. RESULTS: All seven TAR groups completed and returned the survey. Five out of seven groups reported a general policy that included searching for and including studies available as conference abstracts/presentations. Five groups responded that if they included data from these sources they would carry out methodological quality assessment of studies from these sources using the same assessment tools as for full publications, and manage the data from these sources in the same way as fully published reports. All groups reported that if relevant outcome data were reported in both an abstract/presentation and a full publication, they would only consider the data in the full publication. Conversely, if data were only available in conference abstract/presentation, all but two groups reported that they would extract and use the data from the abstract/presentation. In total, 63 HTA reports for NICE were identified. In 20 of 63 TARs (32%) explicit statements were made with regards to inclusion and assessment of data from abstracts/presentations. Thirty-eight (60%) identified at least one randomised controlled trial (RCT) available as a conference abstract or presentation. Of these, 26 (68%) included trials available as abstracts/presentations. About 80% (20/26) of the 26 TARs that included RCTs in abstract/presentation form carried out an assessment of the methodological quality of such trials. In 16 TARs full reports of these trials were used for quality assessment where both abstracts/presentations and subsequent full publications were available. Twenty-three of 63 TARs (37%) carried out a quantitative analysis of results. Of these, ten (43%) included trials that were available as abstracts/presentations in the review; however, only 60% (6/10) of these included data from abstracts/presentations in the data analysis of results. Thirteen TARs evaluated rapidly evolving technologies and only three of these identified and included trial data from conference abstracts/presentations and carried out a quantitative analysis where abstract/presentation data were used. These three TARs were used as case studies. In all three case studies the overall quality of reporting in abstracts/presentations was generally poor. In all case studies abstracts and presentations failed to describe the method of randomisation or allocation concealment. Overall, there was no mention of blinding in 66% (25/38) of the abstracts and in 26% (7/27) of the presentations included in case studies, and one presentation (4%) explicitly stated use of intention-to-treat analysis. Results from one case study demonstrated discrepancies in data made available in abstracts or online conference presentations. Not only were discrepancies evident between these sources, but also comparison of conference abstracts/presentations with subsequently published full-length articles demonstrates data discrepancies in reporting of results. Sensitivity analyses based on one case study indicated a change in significance of effect in two outcome measures when only full papers published to date were included. CONCLUSIONS: There are variations in policy and practice across TAR groups regarding searching for and inclusion of studies available as conference abstracts/presentations. There is also variation in the level of detail reported in TARs regarding the use of abstracts/presentations. Therefore, TAR teams should be encouraged to state explicitly their search strategies for identifying conference abstracts and presentations, their methods for assessing these for inclusion, and where appropriate how the data were used and their effect on the results. Comprehensive searching for trials available as conference abstracts/presentations is time consuming and may be of questionable value. However, there may be a case for searching for and including abstract/presentation data if, for example, other sources of data are limited. If conference abstracts/presentations are to be included, the TAR teams need to allocate additional time for searching and managing data from these sources. Incomplete reporting in conference abstracts and presentations limits the ability of reviewers to assess confidently the methodological quality of trials. Where conference abstracts and presentations are considered for inclusion in the review, the TAR teams should increase their efforts to obtain further study details by contacting trialists. Where abstract/presentation data are included, reviewers should discuss the effect of including data from these sources. Any data discrepancies identified across sources in TARs should be highlighted and their impact discussed in the review. In addition, there is a need to carry out, for example, a sensitivity analysis with and without abstract/presentation data in the analysis. There is a need for research into the development of search strategies specific to identification of studies available as conference abstracts and presentations in TARs. Such strategies may include guidance with regard to identification of relevant electronic databases and appropriate conference sites relevant to certain clinical areas. As there are limited case studies included in this report, analyses should be repeated as more TARs accrue, or include the work of other international HTA groups.

Adult↗

Traditional Chinese medicine (phytotherapy): Health Technology Assessment report - selected aspects.

OBJECTIVE: A summary of main aspects from a Health Technology Assessment report on Traditional Chinese Medicine (TCM) in Switzerland concerning effectiveness and safety is given. MATERIALS AND METHODS: Literature search was performed through 13 databases, by scanning reference lists of articles and by contacting experts. Assessed were quality of documentation, internal and external validity. RESULTS: Effectiveness: 43 articles concerning 'gastrointestinal tract and liver' were assessed. The studies covering 7,436 patients were undertaken in China (35), Japan (3), USA (2) and Australia (3); 33/43 being controlled studies. 34/40 show significantly better results in the TCM-treated group. A comparison of studies on results of treatment based on a diagnosis according to TCM criteria and studies on results of treatment according to Western diagnosis shows that treatment based on TCM diagnosis improves the result. The comparison of treatment by individual medication and standard medication showed a trend in favor of individual medication. SAFETY: TCM training and practice for physicians in Switzerland are officially regulated. Side effects occur, but no severe effects have been registered up to now in Switzerland. TCM medicinals are imported; admission regulations are being installed. Problems due to production abroad, Internet trade, self-medication or admixtures are possible. CONCLUSION: The evaluation of the literature search provides evidence for a basic clinical effectiveness of TCM therapy. Severe side effects were not observed in Switzerland. Regulations for trading and use of medicinals prevent treatment risks. Further clinical studies in a Western context are required.

Drugs, Chinese Herbal↗

[Ethical aspects of short health technology assessments--a systematic review].

Ethical aspects are of high relevance to Short Health Technology Assessments (HTAs). We therefore conducted a systematic review to find out to what extent ethical aspects have been considered in previous Short HTAs. We included articles whose title or abstract suggested that it was a "short", "rapid" or "brief" assessment published in German, English, or French. 272 out of 513 Short HTAs were included. Twenty-five publications (9%) explicitly mentioned ethical aspects, 32 publications (12%) dealt with ethical aspects without explicitly addressing them as 'ethical', 208 publications (76%) did not consider ethical aspects and in another 7 publications (3%) ethical aspects were not relevant. Short HTAs are regularly used to assess sparsely evaluated and/or emerging technologies for which a particular need for an ethical assessment can be assumed. However, the majority of the Short HTAs included in this review did not consider ethical aspects. In this article we therefore suggest a set of key words that will allow authors of Short HTAs to do a systematic literature search for ethical papers in their respective subject of investigation.

Biomedical Technology↗

Telemental health technology in deaf and general mental-health services: access and use.

Long-distance travel to provide mental health services for deaf people has implications for efficiency, safety, and equality of service. However, uptake of Telemental Health (TMH) has been slow in both deaf and general mental health services. A quantitative study was used to investigate access to TMH and whether staff confidence, experience, or demographics affect TMH use. It was concluded that staff in neither deaf mental health services nor general mental health services had adequate knowledge of or access to TMH. Staff expressed concerns over TMH's appropriateness in their work. Previous use of videoconferencing was assosciated significantly with confidence, but previous use of videophones was not. Neither staff in deaf services nor deaf staff were more experienced with or more confident about videoconferencing, whereas, within deaf services, deaf staff were significantly more confident about videophone use. Training implications are discussed.

Adolescent↗

[The indications for the appropriate use of magnetic resonance. The Health Technologies Evaluation Service of the Department of Health of the Basque Government, Osteba].

Magnetic resonance imaging (MRI) allows the non-invasive obtention of diagnostic images, with no ionizing radiation emission and in any space plane. It has a great capacity to differentiate anatomic structures, and it is very useful for planning surgery or radiotherapy. It is the first choice diagnostic technique in conditions involving the central nervous system, useful for establishing diagnosis, surgery planning, and following lesions involving the spinal cord and spine. In the musculoskeletal system it may become and appropriate alternative to arthroscopy. Nevertheless, it is of limited use for the diagnosis of chest, abdominal and pelvic pathology.

Abdomen↗

The role of economic appraisal in health technology assessment: the Australian case.

This paper examines the role and importance of economic appraisal of health technology in Australia, particularly those appraisals conducted under the auspices of a Federal Committee. Eight specific examples are considered: extracorporeal shock wave lithotripsy, office pathology testing, magnetic resonance imaging, cervical cancer screening, bone mineral assessment, automated implantable cardiac defibrillators, liver transplantation and extracorporeal membrane oxygenation. It was found that in most cases the appraisal influenced policy, but that it was harder to assess whether there had been changes in practice or final health outcomes. It is concluded that the roles and relationships of the various players in technology assessment need to be clear, that appropriate incentives are required if socially desirable priorities are to be achieved and that the application of economic appraisal techniques needs to be timely and relevant.

Absorptiometry, Photon↗

[Health technology assessment: Critical scientific methods for evaluating the effects of medical interventions].

In all western countries health care budgets are under considerable constraint and therefore a reflection process has started on how to gain the most health benefit for the population within limited resource boundaries. The field of health technology assessment (HTA) has evolved over the last 15 years in order to bring some objectivity and rationality in the discussion and to evaluate health interventions systematically not only under clinical, but also under economic and organisational perspectives. The research area is internationally well established and is being used increasingly more in Austria and Germany. In this article the method of HTA and its general applications as well its explosive nature are presented.

Austria↗

End-user involvement in health technology assessment (HTA) development: a way to increase impact.

OBJECTIVES: A mechanism to increase the influence of Health Technology Assessments (HTAs) on hospital policy decisions was developed. METHODS: We describe the process and results of an experiment in which a local in-hospital HTA unit was created to provide sound evidence on technology acquisition issues, and to formulate locally appropriate policy recommendations. The Unit consists of a small technical staff that accesses and synthesizes the evidence incorporating local health and economic data, and a Policy Committee that develops policy recommendations based on this evidence. It represents administration, health-care professionals, patients, and representatives of the clinical disciplines affected by each issue. The level of success of the Unit was independently evaluated. RESULTS: To date, 16 reports have been completed, each within 2-4 months. Five recommended unrestricted use, seven recommended rejection, and four recommended very limited use of the technology in question. All have been incorporated into hospital policy. Budget impact is estimated at approximately 3 million dollars of savings per year. CONCLUSIONS: This local in-house HTA agency has had a major impact on the adoption of new technology. Probable reasons for success are (i) relevance (selection of topics by administration with on-site production of HTAs allowing them to incorporate local data and reflect local needs), (ii) timeliness, and (iii) formulation of policy reflecting community values by a local representative committee. Because over one third of all health-care costs are incurred in the hospital, diffusion of this model could have a significant effect on the quantity and quality of health-care spending.

Budgets↗

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.

England↗

View of health technology assessment from the swampy lowlands of general practice.

This article seeks to comment on the approaches to health technology assessment (HTA) outlined in the four main country studies in this volume. It is written from the perspective of a general practitioner working in an inner city area in the United Kingdom and argues that, from the point of view of the clinician, HTA delivers considerably less than it promises. The problems center on the inevitability of judgment by both politicians and clinicians and the conflicting foundations of these judgments. Within political decision-making, the needs of the population inevitably outweigh the needs of the individual; within clinical decision making, the opposite is the case. Attempting a scientific rationality, HTA struggles with the impossibility of holding the balance between the two. These difficulties are further compounded by the implications of ever-increasing expectations of perfect health and the effects of multinational commercial pressures.

Family Practice↗

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.

Decision Support Systems, Clinical↗

The medical technologist and evaluation of health technologies.

Increased social pressure for accountability in the medical care fields and recognition that new and expensive health care technologies have limited impact on health status has brought acknowledgment that the United States has no rational approach to identification, evaluation, and implementation of innovative medical technologies. As in other health care sectors, comprehensive and long-range evaluation of impacts of new medical laboratory technology on both the laboratory and the patient are lacking. It is evident that as questions concerning cost effectiveness are raised, more rigorous evaluation of laboratory technologies must be undertaken. Federal legislation has mandated creation of a National Center for Health Care Technology (NCHCT) with a primary mission to stimulate assessment of health care technologies. This legislation could provide the basis for a more rational approach to technology assessment. Potential implications of technology assessment on laboratory practices and third party reimbursement policy, as well as potential opportunities for laboratory professionals, are discussed.

Government Agencies↗

Health technology assessment: a sociological commentary on reflexive innovation.

This study provides a sociological commentary on the current debates within health technology assessment (HTA), specifically in response to the approaches taken in France, The Netherlands, Sweden, and the United Kingdom. It argues that HTA is part of a wider reflexive innovation system that seeks to order current and prospective technologies. The study discusses the socio-political process of HTA priority setting, the rhetorical role of HTA, the localised and contingent use of HTA, and the policy gap between guidelines and practice. It argues for the development of new types of methodologies for assessment and for a stronger social embedding of HTA practice.

Decision Making, Organizational↗

The U.K. NHS economic evaluation database. Economic issues in evaluations of health technology.

OBJECTIVE: The U.K. NHS Economic Evaluation Database (EED) project is commissioned to identify papers on economic evaluations of health technologies and to disseminate their findings to NHS decision makers by means of structured abstracts that are available through a public database and the Cochrane Library. This paper discusses current issues relating to the economic aspects of producing NHS EED abstracts. METHODS: A review of NHS EED was undertaken between 1994 and 1999 to determine the methodologies adopted and issues that influence the usefulness of economic evaluations. Methods adopted to improve the quality of NHS EED abstracts are also reported. RESULTS: Eighty-five percent of NHS EED abstracts are cost-effectiveness analyses (CEAs), 9.3% are cost-utility analyses (CUAs), and only 1.4% are cost-benefit analyses (CBAs). Of the total abstracts, 65.9% are based on single studies, 19.5% on reviews, 3.9% on estimates of effectiveness, and 10.7% on combinations of these sources. Models are utilized in 16.7% of CEAs, 60.2% of CUAs, and 20% of CBAs. Analyses of CBA studies reveal a degree of misuse of well-established definitions. NHS EED internal control mechanisms are reported that provide a means of ensuring that abstracts are based on sound academic principles. CONCLUSIONS: Most economic evaluations are conducted by means of CEA, followed by CUA, while CBA accounts for an extreme minority of cases. Single studies form the principal source of effectiveness data, although models are widely used, principally in CUA. The structure of NHS EED abstracts provides decision makers with the principal results and an interpretation of the relative strengths and weaknesses of economic evaluations.

Abstracting and Indexing↗

The Swedish State Health Technology Board (SBU) report on treatment of alcohol and drug misuse: an economist's view.

The Swedish State Health Technology Board (SBU) has published a Report on the treatment of alcohol and drug misuse (SBU, 2001). This article is a brief Commentary on the economic issues raised in Chapter 9 of the Report, in particular, the question of 'how cost-effective are the different treatment alternatives?' An outline is given of how the authors approached the economic work, with particular reference to a standard checklist approach to judging the quality of published economic appraisals. A paucity of such appraisals was retrieved and detailed review of just 16 papers was undertaken. The authors are critical of the lack of quality of economic work in the substance misuse area and their main points are summarized here. The main conclusion drawn is that no economic judgements can be made about alternative treatment approaches, and more study and research are needed in this area. Chapter 9 is, on balance, a good attempt at a critical review of the economic appraisal literature. Unfortunately the main Report provides a series of summary judgements on the effectiveness or otherwise of alternative treatments, which, while recognizing the need for further cost-effectiveness work, essentially ignores the conclusion drawn in the economics chapter. This is likely to do a disservice to the cause of appropriate resource allocation in the substance misuse area.

Alcoholism↗