Endovascular grafts are a new, experimental surgery for AAAs that alleviates the need for open abdominal surgery. They offer an important alternative for high risk patients who would be at a greater risk with the more invasive surgical procedure. However, this is based on limited evidence, and more randomized controlled trials are needed. The procedure may be cheaper than open surgery, because of the lengthy hospital stay and operating room time with the latter, provided that the costs of the devices are low enough. However, there is insufficient data on the outcomes with endovascular grafts in different patient groups. As with many new or minimally invasive techniques, there is a "learning curve" which will affect costs and outcomes. Endovascular grafting is no exception, and repeated practical applications are needed for competence, expertise and good outcomes. Continued monitoring of this technique is needed. A registry of elective AAA patients now has 10-year follow-up data on about a third of the Canadian patients operated on in 1988. Further development of such registries will provide more accurate information on success rates, costs, and long-term complications.
Social, ethical and policy analysis of the issues arising from gene patenting and commercial genetic testing is enhanced by the application of science and technology studies, and Actor-Network Theory (ANT) in particular. We suggest the potential for transferring ANT's flexible nature to an applied heuristic methodology for gathering empirical information and for analysing the complex networks involved in the development of genetic technologies. Three concepts are explored in this paper--actor-networks, translation, and drift--and applied to the case of Myriad Genetics and their commercial BRACAnalysis genetic susceptibility test for hereditary breast cancer. Treating this test as an active participant in socio-technical networks clarifies the extent to which it interacts with, shapes and is shaped by people, other technologies, and institutions. Such an understanding enables more sophisticated and nuanced technology assessment, academic analysis, as well as public debate about the social, ethical and policy implications of the commercialization of new genetic technologies.
The purpose of Health Technology Assessment (HTA) is to make the best possible summary of the evidence regarding specific health interventions in order to influence health care and policy decisions. The need for decision makers to find relevant HTA data when it is needed is a barrier to its usefulness. These barriers are highest in rural areas and amongst isolated practitioners.
A multidisciplinary team developed an interactive case-based instructional strategy on the topic of chronic non-cancer pain (CNCP) management using clinical evidence derived by HTA. The evidence for each of 18 CNCP interventions was distilled into single-sheet summaries. Clinicians and HTA specialists ('Ambassadors') conducted 11 two-hour interactive sessions on CNCP in eight of Alberta's nine health regions. Pre- and post-session evaluations were conducted.
The sessions were attended by 130 individuals representing 14 health and administrative disciplines. The ambassador model was well received. The use of content experts as ambassadors was highly rated. The educational strategy was judged to be effective. Awareness of the best evidence in CNCP management was increased. Although some participants reported practice changes as a result of the workshops, the program was not designed to measure changes in patient outcome.
The ambassador program was successful in increasing awareness of the best evidence in CNCP management, and positively influenced treatment decisions. Its teaching methods were felt to be unique and innovative by participants. Its methods could be applied to other clinical content areas in order to increase the uptake of the results of HTA.
Cites: J Contin Educ Health Prof. 2002 Fall;22(4):214-2112613056
Cites: J Health Soc Policy. 2002;15(3-4):23-3712705462
(1) Anakinra is an interleukin-1 receptor antagonist (IL-1ra), which blocks interleukin-1 (IL-1), a protein involved in the inflammation and the joint destruction associated with rheumatoid arthritis (RA). (2) The manufacturer's submission for drug approval is currently under review by Health Canada and the FDA. (3) In randomized controlled trials, patients with severe RA were treated with anakinra. Significant improvement was demonstrated in several clinical, radiologic and health-related quality of life measures in patients treated with anakinra versus placebo. (4) Minimal adverse effects, mainly injection site reactions, were reported.
Assessments of health technologies increasingly include economic evaluations conducted alongside clinical trials. One particular concern with economic evaluations conducted alongside clinical trials is the generalizability of results from one setting to another. Much of the focus relating to this topic has been on the generalizability of results between countries. However, the characteristics of clinical trial design require further consideration of the generalizability of cost data between centers within a single country, which could be important in decisions about adoption of the new technology.
We used data from a multicenter clinical trial conducted in the United Kingdom to assess the degree of variation in costs between patients and between treatment centers and the determinants of the degree of such variation.
The variation between patients was statistically significant for both the experimental and conventional treatments. However, the degree of variation between centers was only statistically significant for the experimental treatment. Such variation appeared to be a result of hospital practice, such as payment mechanisms for staff and provision of hostel accommodation, rather than variations in physical resource use or substantive differences in cost structure.
Multicenter economic evaluations are necessary for determining the variations in hospital practice and characteristics that can in turn determine the generalizability of study results to other settings. Such analyses can identify issues that may be important in adopting a new health technology. Analysis is required of similar large multicenter trials to confirm these conclusions.
Despite the inclusion of equity in the design of many health care systems, pragmatic tools for considering equity systematically, alongside the efficiency categories of cost-effectiveness in health technology assessment (HTA), remain underdeveloped. This article develops a framework to help decision makers supplement the standard efficiency criteria of HTA and avoid building inequities, explicit or implicit, into their methods. The framework is intended as a first step toward creating a checklist for alerting decision makers to a wide range of equity considerations for HTA. This framework is intended be used as part of the process through which advisory bodies receive their terms of reference; scope the agenda prior to the selection of a candidate intervention and its comparators for HTA; prepare background briefing for decision makers; and help to structure the discussion and composition of professional and lay advisory groups during the assessment process. The framework is offered as only a beginning of an ongoing process of deliberation and consultation, through which the matters covered can be expected to become more comprehensive and the record of past decisions and their contexts in any jurisdiction adopting the tool can serve to guide subsequent evidence gathering and decisions. In these ways, it may be hoped that equity will be more systematically and fully considered and implemented in both the procedures and decisions of HTA.
Xenotransplantation, or the use of animal cells, tissues and organs for humans, has been promoted as an important solution to the worldwide shortage of organs. While scientific studies continue to be done to address problems of rejection and the possibility of animal-to-human virus transfer, socio-ethical and legal questions have also been raised around informed consent, life-long monitoring, animal welfare and animal rights, and appropriate regulatory practices. Many calls have also been made to consult publics before policy decisions are made. This paper describes the Canadian public consultation process on xenotransplantation carried out by the Canadian Public Health Association in an arm's length process from Health Canada, the ministry overseeing government health policy and regulation. Focusing on six citizen for a conducted around the country patterned after the citizen jury deliberative approach, the paper describes the citizen panelists' recommendations to hold off on proceeding with clinical trials and the rationales behind this recommendation. The consultation process is discussed in the context of constructive technology assessment, a framework which argues for broader input into earlier stages of technology innovation, particularly at the technology design stage.
Key decisions regarding the introduction and optimal use of health technologies often are made on an ad hoc basis. Quantitative information on effectiveness, if incorporated into the decision-making process, would establish a reasoned and defensible basis for the introduction and optimal use of therapeutic technologies. Utility measures provide a single summary score of effectiveness which, when combined with cost information, permits the calculation of cost-utility ratios for alternative technologies. A number of techniques have been developed to elicit utilities, including standard gamble, time trade-off, rating scales, the Quality of Well-Being Scale, and the Health Utility Index. No single method has been accepted yet as the gold standard. Selection therefore must be guided by the specific objectives of the assessment.
OBJECTIVE--To evaluate the appropriateness of performing coronary angiography and revascularization in a Swedish population. DESIGN--Prospective population study of questionnaires and medical records. SETTING--All the hospitals in southwestern Sweden that perform coronary angiography and revascularization. PATIENTS--Random sample of 831 patients (with chronic stable angina) on the waiting list for coronary angiography or revascularization in southwestern Sweden in September 1990. MAIN OUTCOME MEASURE--Percentage of patients referred for coronary angiography or revascularization for appropriate, uncertain, or inappropriate indications. RESULTS--Of the patients referred for angiography, 89% were classified as appropriate, 9% as uncertain, and 2% as inappropriate. The percentages are similar for patients referred for coronary artery bypass graft surgery and for angioplasty (91% and 86%, respectively, classified as appropriate). The majority of patients had chest pain rated as Canadian Cardiovascular Society classes II through IV (93%), despite maximum anti-ischemic therapy in 90% of these patients. CONCLUSIONS--Few patients were referred for coronary angiography or revascularization for inappropriate or uncertain indications. The percentage of these patients who are from southwestern Sweden is similar to the percentage recently reported from New York State.
Comment In: JAMA. 1994 Oct 26;272(16):1254-57933367