Objectives: Post-listing assessment of pharmaceuticals depends on national habits. In England, the assessment is based on estimates of cost per quality-adjusted life-year. These are made some considerable time after listing (negative list). In France, effectiveness, and then efficiency, is assessed immediately after listing (positive list). We propose a new formal method—the REAL method—that can help make early comparisons of the effectiveness of medical treatments.

Methods: Relative efficacies are first obtained from randomized controlled trials (RCTs). Members of the Transparency Committee (French National Authority for Health) are then consulted by questionnaire on the transposability of these results to real life. The RCT results and experts’ ratings are entered into an effect model to obtain estimates of relative effectiveness, using unidimensional scaling, and bootstrap procedures.

Results: Application of the REAL method to the example of a new drug to treat Parkinson's disease and three comparators used in the same indication provided graphs of the distributions of their relative efficacy and relative effectiveness. The new drug was found to provide no added value.

Conclusions: The REAL method is a rational, transparent, and practical procedure for comparing the effectiveness of pharmaceuticals in an immediate post-listing setting.

An evaluation was conducted of the approaches, costs, and quality-of-life outcomes associated with communication aid assessment programs for the speech-impaired provided by specialist Communication Aids Centres (CACs) in the United Kingdom. The average costs of CAC assessment programs was £410 per client, which is not excessive. There was evidence of moderate quality-of-life benefits from clients' use of the recommended aids.

The Netherlands is a small country of about 15 million inhabitants. With 400 inhabitants per square kilometer, it is one of the most densely populated areas of the world (19). Here, government is not seen as negative, but as a tool to solve societal problems. Ordinarily, the public and private sectors work cooperatively together, but the government will step in when needed. (19, 20).

We determined the distribution and sophistication of obstetric technologies in all 80 maternity hospitals in the state of Washington and examined the effect of rural or urban location, birth volume, and physician staffing on technological intensity. Although smaller and more rural hospitals refer most premature and low-birth-weight infants to regional referral centers, sophisticated prenatal and intrapartum technologies are available in the majority of even the smallest and most remote rural units. Rural hospitals have slightly lower obstetrical intervention rates than do their urban counterparts, but the differences are not great.

Objectives: The aim of this study was to describe the evolution of a cost-utility model used to inform the UK National Institute for Health and Clinical Excellence's (NICE) most recent decisions on the cost-utility of drug treatments for Alzheimer's disease (AD), and to explore the impact of structural assumptions on the cost-utility results.

Methods: Changes informed by noted limitations of the decision model used in NICE's previous decisions (in 2006) were made cumulatively to the original decision model for donepezil compared with best supportive care (for patients with mild to moderate AD). Deterministic and probabilistic analyses were undertaken for each cumulative change of the model. The expected value of perfect information (EVPI) of parameter estimates and structural assumptions was also calculated.

Results: Cumulative changes to the decision model highlighted how the results of the original model (incremental cost-effectiveness ratio of £81,000 per quality-adjusted life-year gained) related to those of the new model (where donepezil was estimated to be cost-saving), mainly due to uncertainty in the incremental cost of donepezil treatment over best supportive care (ranging from -£600 to £3,000 per patient). The partial EVPI analysis reflected this finding where further information on treatment discontinuations and cost parameter estimates were shown to be valuable in terms of reducing decision uncertainty.

Conclusions: Assessing the evolution of the cost-utility model helped to identify and explore structural differences between cohort-based models and is likely to be useful for decision models in other disease areas. This approach makes the structural uncertainty explicit, forcing decision makers to address structural uncertainty in addition to parameter uncertainty.

Objectives: The aim of this study was to assess whether publications of importance for improving the health system and its technologies are highly cited intrascientifically.

Methods: Bibliometric assessment of the 596 publications used as sources in the fifty SBU Alerts from 2001to 2004 from the Swedish Council on Technology Assessment in Health Care was carried out using the Thomson Scientific citation indexes. Normalized citation scores were calculated for all included studies. Additional factors such as the time and place of the research, subject categories, and journal source were analyzed.

Results: On average, the sources in SBU Alert have been cited eight times more than the world average consistently during the time period and across research areas. Articles used as its scientific basis are often published in a few, high impact, general medical journals. However, many of the articles are published in field-specific journals with low impact factors. Most articles used in SBU Alert are published by authors based in the United States or the United Kingdom. However, Swedish, Danish, and Dutch publications are overrepresented in its science base, whereas Japanese, Taiwanese, Indian, and Russian publications are underrepresented.

Conclusions: Publications used as sources in a Swedish system for identification and early assessment of new methods in health care are also highly cited within the scientific community. This finding increases the appropriateness of using bibliometric indicators in evaluations of clinical research and suggests that decision makers through SBU Alert are getting scientifically sound advice.

Objectives: Various minimal clinically important difference (MCID) threshold estimation techniques have been applied to seasonal allergic rhinitis (SAR). The objectives of this study are to (i) assess the difference in magnitude of alternative SAR MCID threshold estimates and (ii) evaluate the impact of alternative MCID estimates on health technology assessment (HTA).

Methods: Data describing change from baseline of the reflective Total Nasal Symptom Score (rTNSS) for four intranasal SAR treatments were obtained from United States Food and Drug Administration-approved prescribing information. Treatment effects were then compared with anchor-based MCID thresholds derived by Barnes et al. and thresholds obtained from an Agency for Healthcare Research and Quality (AHRQ) panel.

Results: The change in rTNSS score from baseline, represented as the average of the twice-daily recorded scores of the rTNSS, was -2.1 (p < .001) for azelastine hydrochloride 0.10%, 1.35 (p = .014) for ciclesonide, and -1.47 (p < .001) for fluticasone furoate. The change in the rTNSS score from baseline, represented by sum of the AM and PM score, was -2.7 for MP-AzeFlu (p < .001). The rTNSS change from baseline for each product was compared with anchor-based MCID threshold and the AHRQ panel estimates. Comparison of the observed treatment effect to the anchor-based and AHRQ panel MCID thresholds results in different conclusions, with clinically important differences being inferred when anchor-based estimates serve as the reference point.

Conclusion: The AHRQ panel MCID threshold for the rTNSS was twelve times larger than the anchor-based estimates resulting in conflicting recommendations on whether different SAR treatments provide clinically meaningful benefit.

Among alcohol and narcotics, alcohol is most comprehensively documented as a teratogen. However, for all other narcotics, data are continuously accumulating, convincingly displaying the teratogenic effects. The proportions between “somatic” teratogenicity and “behavioral” teratogenicity vary between the different agents. Preventive work in prenatal clinics and among social workers, as well as objective mass media attention to the problem, seems to have lowered the incidence of severe fetal alcohol syndrome where the above-mentioned activities have been practiced. The female alcohol consumption in Sweden decreased from 1976 to 1985; thereafter, a slow continuous increase is underway again, in Sweden the number of recruits to narcotic abuse peaked in the 1970s and early 1980s. Thereafter, the number of recruits among females decreased, but abuse has continued among the members of the older age groups.

The establishment of health technology assessment (HTA) has been an important topic in Europe for many years. There have been a series of activities starting with first projects in 1994 leading to joint actions from the European Network of HTA (EUnetHTA) ending in 2021. This long interval of engagement with HTA structures, methodology, and processes by all member states led to a reliable basis for European collaboration in HTA. This article shows milestones and developments from EUR-ASSESS in 1994 through the progress of EUnetHTA and the accompanying EU-HTA-Network up to the recent elaboration of the EU-HTA-Regulation. With the EU-HTA-Regulation HTA collaboration is taken out of the trial phase of more than 15 years. Through the previous EU HTA collaboration, the appreciation and understanding of the differences and complexities behind the HTA processes in the EU healthcare systems have improved. It is now necessary to make the final steps toward a sustainable European Network for HTA.

Viewed in relation to the vast amount of clinical research in the United States, the number of total artificial heart (TAH) implants is so small as to be statistically invisible. And while the results of those implants to date may seem dubious in terms of the recipients' outcomes, theyare in fact very similar to those of many other innovative therapies when they are first tried ondesperately ill patients. Why, then, has the artificial heart been the object and subject of suchextraordinary interest and controversy? It has been the subject of special federal studies, reports, and hearings for 20 years; has been perceived and portrayed as a unique chapter in the annals of human experimentation and therapeutic innovation; has attracted medically unprecedented media attention; and, in the case of permanent implants, has received unusually exhaustive and restrictive regulatory supervision.

Agreement between two expert panels in assessing gain in life expectancy and quality of life from unselected stays in a department of internal medicine was investigated. Weighted kappa statistics of 0.45 for gain in life expectancy and 0.63 for gain in quality of life were found.

A rapidly growing interest in medical technology assessment has been noted in Sweden during the last 5 years. This interest is reflected both in a variety of research efforts and in new organizational arrangements for coordination and stimulus of research. A special area of concern is a group of mechanisms to make the results of assessment useful to medical practitioners and in the political and administrative process within health care.

This article reviews nonexperimental data bases, emphasizing the present uses and future opportunities of routinely collected information. Data bases are discussed in terms of appropriate research designs. Possibilities for expanding available information through new data collection and through record linkage are stressed. The relationship of nonexperimental data systems to randomized trials and to clinical decision-making is examined.

Objectives: The relatively high cost of information technology systems may be a barrier to hospitals thinking of adopting this technology. The experiences of early adopters may facilitate decision making for hospitals less able to risk their limited resources. This study identifies the costs to design, develop, implement, and operate an innovative informatics-based registry and disease management system (POPMAN) to manage type 2 diabetes in a primary care setting.

Methods: The various cost components of POPMAN were systematically identified and collected.

Results: POPMAN cost $450,000 to develop and operate over 3.5 years (1999–2003). Approximately $250,000 of these costs are one-time expenditures or sunk costs. Annual operating costs are expected to range from $90,000 to $110,000 translating to approximately $90 per patient for a 1,200 patient registry.

Conclusions: The cost of POPMAN is comparable to the costs of other quality-improving interventions for patients with diabetes. Modifications to POPMAN for adaptation to other chronic diseases or to interface with new electronic medical record systems will require additional investment but should not be as high as initial development costs. POPMAN provides a means of tracking progress against negotiated quality targets, allowing hospitals to negotiate pay for performance incentives with insurers that may exceed the annual operating cost of POPMAN. As a result, the quality of care of patients with diabetes through use of POPMAN could be improved at a minimal net cost to hospitals.

Introduction: Genetic factors affecting warfarin maintenance dose have been well established, but patient acceptance is a necessary consideration for the successful clinical implementation of warfarin pharmacogenetic testing (WPGT). In this study, we aimed to determine the attitudes toward WPGT among Singaporean Chinese.

Methods: A total of 194 warfarin patients and 187 members of the public completed a structured survey on paper and the Internet, respectively. Attitudes were expressed as willingness to undergo WPGT (single item with 5-point response) and expectations and concerns about WPGT (two multi-item scales). Relationships between attitudes and socio-demographic and clinical variables were explored using Fisher's exact test, Student's t-test, one-way analysis of variance or Pearson's correlation.

Results: Majority of respondents were willing to or neutral about undergoing WPGT. Both patients and public had relatively high expectations (mean [SD]: 3.77 [0.63], and 3.97 [0.55], respectively) and moderately high concerns (mean [SD]: 3.30 [0.69] and 3.33 [0.68], respectively) about WPGT. Willingness to undergo WPGT was associated with gender, educational status, length of warfarin treatment, and number of chronic diseases among warfarin patients, and with history of adverse drug reactions and number of chronic diseases among the public. Higher expectation of WPGT was associated with higher willingness (p < .001 in both populations), while higher concern was associated with lower willingness to undergo WPGT among the public (p = .004) but not among patients (p = .072).

Conclusion: Patient acceptance is not a major barrier to clinical implementation of WPGT but patient education is necessary and the ethical, social, and legal issues should be addressed.

Objectives: The news media plays a central role in providing information regarding new medical technologies and exerts an influence on their social perception, understanding, and assessments. This study, therefore, analyzes how healthcare robotics are portrayed in the German print news media. It examines whether the risks and opportunities of new medical technologies are presented in a balanced manner and investigates whether or not print media coverage of these technologies is affected by science-fiction discourse, in which robots appear mostly as a threat to humans.

Methods: Ten years of German print media coverage (2000–2010) have been studied by means of systematic, standardized content analysis.

Results: Reporting focuses predominantly on beneficial advancements in medical practice and the advantages of robotics for patients, medical staff, and society. The results show that the dominant relationship between robots and humans that is transmitted in print media in medical contexts is positive, with robots mostly portrayed as assistants, colleagues, or even friends. Only a small number of articles report ethical questions and risks.

Conclusions: In contrast to science-fiction discourse, the German print media provides a positive picture of robotics to the lay public.