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.

Objectives: Clinical trials have demonstrated that fecal occult blood screening for colorectal cancer can significantly reduce mortality. However, to be deemed a priority from a public health policy perspective, any new program must prove itself to be cost-effective. The objective of this study was to assess the cost-effectiveness of screening for colorectal cancer using a fecal occult blood screening test, the Hemoccult-II, in a cohort of 100,000 asymptomatic individuals 50–74 years of age.

Methods: A decision analysis model using a Markov approach simulates the trajectory of the cohort allocated either to screening or no screening over a 20-year period through several health states. Clinical and economic data used in the model came from the Burgundy trial, French population-based studies, and Registry data.

Results: Modeling biennial screening versus the absence of screening over a 20-year period resulted in a 17.7 percent mortality reduction and a discounted incremental cost-effectiveness ratio of 3,357 € per life-year gained among individuals 50–74 years of age. Sensitivity analyses performed on epidemiological and economic data showed the strong impact on the results of colonoscopy cost, of compliance to screening, and of specificity of the screening test.

Conclusions: Cost-effectiveness estimates and sensitivity analyses suggest that biennial screening for colorectal cancer with fecal occult blood test could be recommended from the age of 50 until 74. Our findings support the attempts to introduce large-scale population screening programs.

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.

Objectives: Decision analysis is commonly used to perform economic evaluations of new pharmaceuticals. The outcomes of such studies are often reported as an incremental cost per quality-adjusted life year (QALY) gained with the new agent. Decision analysis can also be used in the context of estimating drug cost before market entry. The current study used neurokinin-1 (NK-1) receptor antagonists, a new class of antiemetics for cancer patients, as an example to illustrate the process using an incremental cost of $Can20,000 per QALY gained as the target threshold.

Methods: A decision model was developed to simulate the control of acute and delayed emesis after cisplatin-based chemotherapy. The model compared standard therapy with granisetron and dexamethasone to the same protocol with the addition of an NK-1 before chemotherapy and continued twice daily for five days. The rates of complete emesis control were abstracted from a double-blind randomized trial. Costs of standard antiemetics and therapy for breakthrough vomiting were obtained from hospital sources. Utility estimates characterized as quality-adjusted emesis-free days were determined by interviewing twenty-five oncology nurses and pharmacists by using the Time Trade-Off technique. These data were then used to estimate the unit cost of the new antiemetic using a target threshold of $Can20,000 per QALY gained.

Results: A cost of $Can6.60 per NK-1 dose would generate an incremental cost of $Can20,000 per QALY. The sensitivity analysis on the unit cost identified a range from $Can4.80 to $Can10.00 per dose. For the recommended five days of therapy, the total cost should be $Can66.00 ($Can48.00–$Can100.00) for optimal economic efficiency relative to Canada's publicly funded health-care system.

Conclusions: The use of decision modeling for estimating drug cost before product launch is a powerful technique to ensure value for money. Such information can be of value to both drug manufacturers and formulary committees, because it would facilitate negotiations for optimal pricing in a given jurisdiction.

Objectives: To examine the feasibility of retrieving missing outcome data for summary meta-analyses using an example dealing with the effects of aerobic exercise on lipids and lipoproteins in adults.

Methods: Missing lipid and/or lipoprotein data from a currently developed meta-analytic data base were requested by means of electronic mail from 39 of 174 (22.4 percent) eligible studies. Binary logistic regression was used to examine whether year of publication and country were significant predictors for whether data would be provided.

Results: Of the thirty-nine studies from which data were requested, usable data were received for thirteen (33.3 percent) of the studies. The addition of these previously missing data decreased the percentage of eligible studies that would have had to be excluded by 33.5 percent (from 22.4 percent to 14.9 percent). Neither year of publication nor country in which the study was conducted (United States versus other) were significant predictors of whether missing data would be provided or not (p>.05).

Conclusions: Moderate success was achieved in the acquisition of missing outcome data dealing with the effects of aerobic exercise on lipids and lipoproteins in adults. However, whether this level of response is true in other areas of research needs to be determined by additional research.

Certain key parameters such as safety, efficacy, effectiveness, and cost effectiveness have long been established as key in HTA analysis. Equally important, however, are sociolegal and epidemiologic perspectives. A comprehensive analytic framework will consider the implications of using a technology in the context of societal norms, cultural values, and social institutions and relations. The methodology in which this expanded framework has been developed is termed ‘Strategic HTA’ to denote its power for the decision-making process. In addition to systematic reviews of published evidence, it incorporates analyses of the influence of dominant social relations on technological development and diffusion. This essay discusses the social epidemiologic aspects of health technology assessment, which includes factors such as sex and gender. It seeks to show how it is possible to bring data from wide-ranging disciplinary perspectives within the parameters of a single scientific inquiry; to draw from them scientifically defensible conclusions; and thereby to realize a deeper understanding of technology impact within a health care system. Armed with such an understanding, policy officials will be better prepared to resolve the competitive clamor of stakeholder voices, and to make the most “equitable” use of the available resources.

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.

Objective: To study the costs and effects of incorporating ultrasonography in the triple assessment of palpable breast masses.

Methods: A decision analytic model was designed to compare a conventional strategy of performing fine-needle aspiration cytology after clinical examination and mammography, with three different experimental strategies of preceding ultrasonography. Empirical data were used from a prospective study in 522 breasts in 492 patients with a palpable mass, including 93 malignancies. In strategy 1, cases with probably benign, suspect malignant, and malignant ultrasonography results were referred for fine-needle aspiration cytology; in strategy 2, benign cases were also referred for fine-needle aspiration cytology; and in strategy 3, ultrasonography was only performed in patients with benign results on clinical examination and mammography, whereas immediate fine-needle aspiration cytology was performed in patients with suspicious lesions. Outcome variables included the total costs and the expected number of life years. Sensitivity analysis was performed on all parameters in the model.

Results: All strategies reported a similar life expectancy of 31.0 years. Cost-minimization demonstrated that experimental strategy 3 was the least expensive strategy (€ 3,013). Experimental strategy 2 was the most costly one (€ 3,512). Compared with the conventional strategy of immediate fine-needle aspiration cytology (€ 3,087), both ultrasonography strategies 1 and −3 were preferred.

Conclusions: Incorporating ultrasonography in the triple assessment of palpable breast masses can result in a reduction of the total costs for the diagnosis and treatment of breast cancer.

Objectives: The feasibility and accuracy of sentinel lymph node biopsy (SLNB) in the treatment of breast cancer is widely acknowledged today. The aim of our study was to compare the hospital-related costs of this strategy with those of conventional axillary lymph node dissection (ALND).

Methods: A retrospective study was carried out to determine the total direct medical costs for each of the two medical strategies. Two patient samples (n=43 for ALND; n=48 for SLNB) were selected at random among breast cancer patients at the Centre Léon Bérard, a comprehensive cancer treatment center in Lyon, France. Costs related to ALND carried out after SLNB (either immediately or at a later date) were included in SLNB costs (n=18 of 48 patients).

Results: Total direct medical costs were significantly different in the two groups (median 1,965.86€ versus 1,429.93€, p=0.0076, Mann-Whitney U-test). The total cost for SLNB decreased even further for patients who underwent SLNB alone (median, 1,301€). Despite the high cost of anatomic pathology examinations and nuclear medicine (both favorable to ALND), the difference in direct medical costs for the two strategies was primarily due to the length of hospitalization, which differs significantly depending on the technique used (9-day median for ALND versus 3 days for SLNB, p<0.0001).

Conclusions: A lower morbidity rate is favorable to the generalization of SLNB, when the patient's clinical state allows for it. From an economic point of view, SLNB also seems to be preferred, particularly because our results confirm those found in two published studies concerning the cost of SLNB.

This article comments on the four country papers in this volume from an economic perspective. Different phases of the decision-making process, which can be supported by Health Technology Assessment (HTA), are considered. For each of these, there is large cross-country variation in the way in which HTA influences policy. Furthermore, economic themes regarding the relevance of HTA evidence for policy making, the position of cost-effectiveness in relation to other criteria vis-à-vis reimbursement decisions, the use of a cost per quality-adjusted life year threshold, and the incorporation of economic considerations in practice guidelines are discussed.

Objectives: To elucidate important differences between a health technology assessment (HTA) and a systematic review, using an HTA of positron emission tomography (PET) as an example.

Methods: Interviews with seventeen individuals who were authors or users of the PET HTA.

Results: Those interviewed identified seven areas in which HTAs often differ from traditional systematic reviews: (i) methodological standards (HTAs may include literature of relatively poor methodological quality if a topic is of importance to decision-makers), (ii) replication of previous studies (relatively common for HTAs but not systematic reviews), (iii) choice of topics (more policy oriented for HTAs, while systematic reviews tend to be driven by researcher interest), (iv) inclusion of content experts and policy-makers as authors (policy-makers more likely to be included in HTAs, although there are potential conflicts of interest), (v) inclusion of economic evaluations (more often with HTAs, although economic evaluations based upon poor clinical data may not be useful), (vi) making policy recommendations (more likely with HTAs, although this must be done with caution), and (vii) dissemination of the report (more often actively done for HTAs).

Conclusions: This case study of an HTA of PET scanning confirms that HTAs are a bridge between science and policy and require a balance between the ideals of scientific rigor and the realities of policy making.

Objectives: To compare methods and results among four health technology assessment organizations in different countries.

Methods: All assessment reports published between 1999 and 2001 by VATAP (United States), NICE (United Kingdom), CCOHTA (Canada), and AETS (Spain), were reviewed. Detailed information about the organization, the technology assessed, the methods used, and the recommendations made were collected. A descriptive analysis of the variables, as well as comparisons of means and proportions, was performed.

Results: Sixty-one reports assessing seventy-six technologies were published: nine (11.8 percent) by VATAP, thirty-nine (51.3 percent) by NICE, twenty (26.3 percent) by CCOHTA, and eight (10.5 percent) by AETS. A total of 64.5 percent of the technologies assessed were related to a high prevalence disease in the corresponding country. Most of the assessments addressed treatments (73.7 percent) and were mostly drugs (56.6 percent) and devices (23.7 percent). Most organizations used reviews of effectiveness and economic evaluations (64.5 percent), systematic reviews (21.1 percent), and original economic evaluations (36.7 percent). In 38.1 percent, the technology was recommended; the rest of the cases had no formal recommendations.

Conclusions: Critical issues for future technology assessment efforts are making assessment processes more consistent, transparent, and evidence-based; formalizing the inclusion of economic and ethical considerations; and making more explicit the prioritization process for selecting technologies for assessment and reassessment.

Objectives: The cost-effectiveness of fracture prevention treatments (vitamin D and calcium and hip protectors) in male and female populations older than seventy years of age in the United-Kingdom was investigated.

Methods: A Markov model was developed to follow up, over lifetime, a hypothetical cohort of males and females at high-risk and general risk of fracture. Patients could sustain hip, wrist, vertebral, and/or other fractures. Fracture rates were obtained from population surveys in the United Kingdom. Effectiveness and quality of life data were identified from the clinical literature. Costs were those incurred by the UK National Health Service, and were obtained from several published sources. Uncertainty was explored through probabilistic sensitivity analysis.

Results: In the general-risk female (male) population, the incremental cost per Quality Adjusted Life Year (QALY) was $11,722 ($47,426) for hip protectors. In the male high-risk population, the incremental cost per QALY was $17,017 for hip protectors. In the female high-risk population, hip protectors were cost-saving. Vitamin D and calcium alone was dominated by hip protectors in all four subgroups.

Conclusions: Current information available on interventions to prevent fractures in the elderly in the United Kingdom, suggests that, at the decision-maker's ceiling ratio of $20,000 per QALY, hip protectors are cost-effective in the general female population and high-risk male population, and cost-saving in the high-risk female population, despite the low compliance rate with the treatment.

Objectives: This study reviewed the European guidelines of the Committee for Proprietary Medicinal Products (CPMP) on how health-related quality of life (HRQOL) research should be conducted in clinical trials. Published product-level information was also reviewed to investigate the actual role of HRQOL data in the European regulatory process.

Methods: All disease-specific notes for guidance and concept papers on clinical investigations, development and evaluation of human medicinal products, as well as the European Public Assessment Reports (EPAR) of all approved drugs published on the European Agency for the Evaluation of Medicinal Products (EMEA) Web site were evaluated for their HRQOL recommendations.

Results: Only twenty of the fifty CPMP guidance notes for clinical investigation of pharmaceutical products in specific disease areas included a reference to HRQOL. Most of the recommendations were generic and vague, and the terminology used was inconsistent across documents. The EPAR provided nonspecific information about HRQOL and contradictory conclusions on the effect of a drug on HRQOL sometimes occurred in different documents. The criteria used by the CPMP to assess the HRQOL data could not be identified due to an ad hoc approach to the inclusion of data in the EPAR.

Conclusions: A more systematic approach is needed on the way health outcomes data are considered, reviewed, and interpreted by the regulatory authorities. For this to be achieved, CPMP should develop general guidelines on the importance of HRQOL and how research should be conducted if data are to be included in the registration process.

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.

Objectives: Stress urinary incontinence affects between 10 percent and 50 percent of women. Surgery is commonly recommended for troublesome incontinence that does not respond to nonsurgical management. Tension-free vaginal tape (TVT) is a newer, minimal access surgical sling procedure, which is being increasingly adopted worldwide. The cost-effectiveness of TVT in comparison with other surgical procedures, particularly open colposuspension, is assessed.

Methods: Effectiveness estimates came from a systematic review of TVT compared with other surgical procedures (open and laparoscopic colposuspension, traditional slings, and injectables). Deterministic and probabilistic analyses were used to assess the likelihood of TVT being cost-effective. Sensitivity analyses assessed the impact of changing assumptions about cure rates and costs for TVT, cure rates for retreatment open colposuspension, and proportions of women who choose retreatment.

Results: Reliable estimates of relative effectiveness were difficult to derive because the few randomized controlled comparisons had not been optimally analyzed or fully reported. Results of the economic model suggested that TVT dominates open colposuspension (lower cost and same quality of life years[QALYs]) within 5 years after surgery. Stochastic analysis indicated that the likelihood of TVT being cost-effective was 100 percent if decision-makers are unwilling to pay for additional QALYs. TVT's dominance depended on the assumption fact that retreatment open colposuspension has lower cure rates than a first colposuspension.

Conclusions: Analysis based on current short-term data indicates dominance of TVT over open colposuspension from approximately 5 years. There is a need for longer-term follow-up data from methodologically rigorous randomized trials to provide a sounder basis for estimating the relative benefits and cost implications.

Objectives: While strategies for enhancing the dissemination and impact of Health Technology Assessment (HTA) are now being increasingly examined, the characteristics of HTA production have received less attention.

Methods: This study presents the results of a content analysis of the HTA documents (n=187) produced by six Canadian agencies from 1995 to 2001, supplemented by interviews with chief executive officers and researchers (n=40). The goal of this analysis was to characterize the agencies' portfolios and to analyze the challenges these agencies face in responding to the increased demand for HTA.

Results: On average, thirty HTA products were issued annually by the agencies. While the bulk of documents produced were full HTA reports (76 percent), two agencies showed significant diversification in their products. Three agencies in particular actively supported the publication of results in scientific journals. Three agencies showed evidence of adapting to different institutional environments by specializing in certain areas (drugs, health services). Overall, a significant portion of the agencies' HTAs contained data on costs (37 percent) and effectiveness (48 percent), whereas ethical and social issues were rarely addressed (17 percent). Most agencies addressed issues and outcomes that did not strictly fall under the typical definition of HTA but that increased the “contextualization” of their findings.

Conclusions: Our discussion highlights four paradoxes and reflects further on challenges raised by the coordination of HTA within large countries and among European states. This study concludes that HTA is being redefined in Canada as HTA agencies offer a more contextualized informational basis, an approach that may prove more compatible with the increased demand for HTA.

This article reviews the developments in HTA in four countries, France, The Netherlands, Sweden, and United Kingdom, in relation to public health. It emphasizes that the majority of assessments made are concerned with individual clinical care rather than with the optimization of health. Possible reasons for the neglect of public health issues are that these are inherently more complex than the assessment of individual procedures or drugs. They are usually multisectoral, politically charged, and often considered mundane and “common sense” and, thus, not requiring evaluation (although when evaluations are done they are often counterintuitive). Unless more emphasis is given to the development and evaluation of public health measures, it is unlikely that there will be any major advances in health status. Possible areas for future assessment should include such issues as smoking, drug and other substance misuse, nutrition, and health inequalities. However, it is unlikely that these major areas of concern will be included in the future unless the methods of choice for priorities of development and assessment are changed to include measures that improve health status rather than only clinical services.

Objectives: To assess the relative cost-effectiveness of laparoscopic methods of inguinal hernia repair compared with open flat mesh and open non-mesh repair.

Methods: Data on the effectiveness of these alternatives came from three systematic reviews comparing: (i) laparoscopic methods with open flat mesh or non-mesh methods; (ii) open flat mesh with open non-mesh repair; and (iii) methods that used synthetic mesh to repair the hernia defect with those that did not. Data on costs were obtained from the authors of economic evaluations previously conducted alongside trials included in the reviews. A Markov model was used to model cost-effectiveness for a five-year period after the initial operation. The outcomes of the model were presented using a balance sheet approach and as cost per hernia recurrence avoided and cost per extra day at usual activities.

Results:Open flat mesh was the most cost-effective method of preventing recurrences. Laparoscopic repair provided a shorter period of convalescence and less long-term pain compared with open flat mesh but was more costly. The mean incremental cost per additional day back at usual activities compared with open flat mesh was €38 and €80 for totally extraperitoneal and transabdominal preperitoneal repair, respectively.

Conclusions:Laparoscopic repair is not cost-effective compared with open flat mesh repair in terms of cost per recurrence avoided. Decisions about the use of laparoscopic repair depend on whether the benefits (reduced pain and earlier return to usual activities) outweigh the extra costs and intraoperative risks. On the evidence presented here, these extra costs are unlikely to be offset by the short-term benefits of laparoscopic repair.

Objectives: The cost-effectiveness of opportunistic nuchal translucency ultrasound screening in pregnancy was compared with alternative screening strategies for trisomy 21 in Australia.

Methods: A decision analytic model was used of various pregnancy screening strategies based on a systematic review of the literature on the effectiveness of nuchal translucency ultrasound and serum screening and costs based on current reimbursement fees. The model included the likelihood and cost of terminations after diagnostic testing and the associated risk of fetal loss. All prices are in 2001 Australian dollars.

Results: With a twenty percentage point difference in detection rate, the incremental cost for a combination of nuchal translucency and serum screening with age in the first trimester compared with maternal serum screening in the second trimester was $105,484 per extra case detected and $374,779 per live trisomy 21 birth avoided. Serum screening in the second trimester had an incremental cost per extra case detected of between $61,700 and $117,100 per extra live birth avoided when compared with no screening.

Conclusions: The cost-effectiveness of ultrasound screening for trisomy 21 would appear to be more attractive if it were done at the same time as current dating ultrasound. Any funding mechanism for screening should take this strategy into account by incorporating, as far as possible, provision of nuchal translucency screening into existing services provided in early pregnancy.