In this article, we review the development of health technology assessment (HTA) in England and Wales, France, The Netherlands, and Sweden, and we summarize the reaction to these developments from a variety of different disciplinary and stakeholder perspectives (political science, sociology, economics, ethics, public health, general practice, clinical medicine, patients, and the pharmaceutical industry). We conclude that translating HTA into policy is a highly complex business and that, despite the growth of HTA over the past two decades, its influence on policy making, and its perceived relevance for people from a broad range of different perspectives, remains marginal.

Objectives: Health-care technology reviews now increasingly include outcome costs as well as clinical effects. This study reports the findings and implications of a survey to explore the usefulness of the National Health Service Economic Evaluation Database (NHS EED) within this process.

Methods: Postal survey of lead authors of Technology Assessment Reviews (TARs) commissioned by the United Kingdom's National Institute for Clinical Excellence (NICE). The questionnaire investigated the usefulness of NHS EED in terms of (a) search strategy, (b) data extraction, (c) quality assessment, and (d) determining requirements for new modeling studies. Qualitative data were requested, including opinions regarding NHS EED.

Results: NHS EED was used in 90 percent of all identified reviews (n=46). The questionnaire response rate was 63 percent. The percentage of scores 3 or above (most useful), 2 or below (least useful), or N/A were, respectively, (a) search strategy=62 percent, 23 percent, 15 percent; (b) data extraction=23 percent, 27 percent, 50 percent; (c) quality assessment=38 percent, 19 percent, 42 percent; (d) determining requirements for new modeling studies=27 percent, 23 percent, 50 percent. The results were expanded further in the qualitative data from the respondents.

Conclusions: NHS EED is a useful tool for a variety of tasks in the NICE/TAR process but not, unsurprisingly, as a replacement for understanding primary studies. There is, however, a need to reduce the impact of time lags between the publication of economic evaluations and the appearance of abstracts relating to them on NHS EED. The results will inform future developments of the NHS EED database, which should increase its usefulness to researchers.

Women's health issues have in recent years become the focus for an unprecedented degree of sophisticated technologic incursion. While much of rapid technologic advances, confined as it largely is to the richest societies of the globe, has perhaps enabled women to hold their place in the workforce, it has also taken the natural biological processes from the quiet path of individual lives and put them into the hands of expert management. Women's health is now similar to other consumer goods, available for purchase alongside the many commodities of the modern urban lifestyle.

Objectives: The study determined whether the results of recently completed systematic reviews evaluating the effectiveness of public health interventions were used in the development of new provincial policies for public health practice.

Methods: This telephone survey included all members from five review groups who updated the Ontario Mandatory Health Programs and Services guidelines for Public Health in 2000. Independent variables included characteristics of the systematic reviews, organization, and the individual. Outcomes included the use of the reviews in developing new policies and the extent to which the reviews led to new recommendations for practice. Descriptive summaries as well as multiple linear regression were conducted.

Results: Eighty-five percent of decision-makers agreed to participate in the study. Ninety-six percent of respondents reported that the systematic reviews played a part in developing the new guidelines, while 47 percent indicated that the reviews contributed a great deal to the development of new recommendations for practice. The multiple linear regression model explained 42 percent of the variation in use of the reviews for developing new recommendations for practice. Significant predictor variables included the importance of the reviews in comparison to other sources of information and relevance of the reviews to the policy decisions.

Conclusion: Public health decision-makers in Ontario have very positive perceptions of the usefulness of systematic reviews in policy development. Therefore, ongoing efforts to promote the usefulness and relevance of systematic reviews to public health decision-makers should remain a priority for health services researchers.

Objectives: The frequency and consequences of major bleeding associated with anticoagulant prophylaxis for prevention of venous thromboembolism is examined.

Methods: We conducted a systematic review and meta-analysis of controlled trials that reported rates of major bleeding after pharmaceutical thromboprophylaxis in patients undergoing major orthopedic surgery. Thromboprophylactic agents were divided into four groups:warfarin/other coumarin derivatives (WARF), unfractionated heparin (UFH), low molecular weight heparin (LMWH), and pentasaccharide (PS). Meta-analysis was conducted comparing LMWH with each of WARF, UFH, and PS. The frequency of re-operation due to major bleeding was reviewed and combined with published costs to estimate the mean cost of managing major bleeding events in these patients.

Results: Twenty-one studies including 20,523 patients met inclusion criteria for the meta-analysis. No evidence of significant between-trial heterogeneity in risk ratios was found. Combined (fixed effects) relative risks (RR) of major bleeding compared with LMWH were WARF – RR 0.59 (95 percent confidence interval [CI], 0.44–0.80); UFH – RR 1.52 (95 percent CI, 1.04–2.23); PS – RR 1.52 (95 percent CI, 1.11–2.09). Seventy-one studies including 32,433 patients were included in the review of consequences of major bleeding. We estimated that the average cost of major bleeding is $113 per patient receiving thromboprophylaxis.

Conclusions: LMWH results in fewer major bleeding episodes than UFH and PS but more than WARF. These events are costly and clinically important.

Background: Home hemodialysis offers potential advantages over hospital hemodialysis, including the opportunity for more frequent and/or longer dialysis sessions. Expanding home hemodialysis services may help cope with the increasing numbers of people requiring hemodialysis.

Methods: We sought comparative studies or systematic reviews of home versus hospital/satellite unit hemodialysis for people with end-stage renal failure (ESRF). Outcomes included quality of life and survival. We searched MEDLINE, EMBASE, HealthSTAR, CINAHL, PREMEDLINE, and BIOSIS. Two reviewers independently extracted data and assessed the quality of the studies included.

Results: Twenty-seven studies of variable quality were included. People on home hemodialysis generally experienced a better quality of life and lived longer than those on hospital hemodialysis. Their partners, however, found home hemodialysis more stressful. Four studies using a Cox proportional hazards model to compare home with hospital hemodialysis reported a lower mortality risk for home hemodialysis. Of two studies using a Cox model to compare home with satellite unit hemodialysis, one reported a similar mortality risk, whereas the other reported a lower mortality risk for home hemodialysis.

Conclusions: Home hemodialysis was generally associated with better outcomes than hospital hemodialysis and (more modestly so) satellite unit hemodialysis, in terms of quality of life, survival, and other measures of effectiveness. People on home hemodialysis, however, are a highly selected group. Home hemodialysis also provides the opportunity for more frequent and/or longer dialysis sessions than would otherwise be possible. It is difficult to disentangle the true effects of home hemodialysis from such influencing factors.

The province of British Columbia (BC), Canada is developing its first population-wide prenatal genetic screening program, known as triple-marker screening (TMS). TMS, initiated with a simple blood test, is most commonly used to screen for fetuses with the chromosomal abnormality known as Down syndrome or neural tube disorders. Women testing TMS-positive are offered diagnostic amniocentesis and, if the diagnosis is confirmed, selective second-trimester abortion. The project described in this study was initiated to address the broad range of issues arising from this testing technology and provides an example of the new type of health technology assessment (HTA) contribution emerging (and likely to become increasing necessary) in health policy development. With the advent of prenatal genetic screening programs, would-be parents gain the promise of identifying target conditions and, hence, the option of selective abortion of affected fetuses. There is considerable awareness that these developments pose challenges in every dimension (ethical, political, economic, and clinical) of the health-care environment. In the effort to construct an appropriate prenatal screening policy, therefore, administrators have understandably sought guidance from within the field of HTA. The report authors concluded that, within the restricted path open to it, the role of government is relatively clear. It has the responsibility to maintain equal access to prenatal testing, as to any other health service. It should also require maintenance of medical standards and evaluation of program performance. At the same time, policy-makers need actively to support those individuals born with disabilities and their families.

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.

In A Theory of Justice, John Rawls demands from citizens who decide upon principles of justice and the rules derived from such principles that they abstract from all particularities that constitute their identity as unique individuals. This demand is unrealistic in policy settings where actual policy-makers convene to provide guidance, establish rules regarding public good, and enact legislation. In practice, I argue, policy-makers, legislators, and others involved in developing social rules that pertain to distributive justice formulate such rules as reasonably partial spectators. To illustrate, I show how clinical practice guidelines are established and mediated by a reasonably partial expert panel whose partial action is publicly justifiable, yet whose claims to impartiality are not.

Health technology assessment (HTA) in France covers a variety of activities performed for different customers (e.g., health professionals in the field and policy makers in government) for the benefit of patients. To promote the improvement of quality in health care, France has set up a series of distinct agencies that report to the Ministry of Health but are also accountable to their other customers. We place particular emphasis on ANAES (National Agency for Accreditation and Evaluation in Health) whose main remit is HTA. We show how the diversity of HTA activities and their decentralization suggests tight collaboration among all the different bodies which perform HTA or are closely involved with HTA, and we provide examples of such collaboration.

Objectives: To conduct a systematic review of selected health determinants, including gender, and their impact on hospitalization rates for depression. Depression includes both depressive and bipolar disorders. Selected health determinants were gender, age, sex, family structure, education, and socioeconomic status.

Methods: Systematic search of conventional and fugitive literature sources. All reports of primary data, systematic reviews, and meta-analysis of primary data were included if they focused on hospitalization for depression and reported data by one or more of the selected health determinants. Two researchers independently evaluated each citation for inclusion and extracted data from the included studies.

Results: There is an important underreporting of health determinants data in studies of hospitalization for depression. No studies examined the role of gender. Age and sex were reported in 83 percent and 80 percent of the 110 included studies. Women showed a higher rate of hospitalization for depression than men (p<.05). Age and diagnosis had different effects in men and women. Adult women were significantly more likely than men to report a depressive disorder, whereas men were more likely to report a bipolar disorder (p<.05). Little can be concluded on the other health determinants.

Conclusions: The importance of reporting hospitalization data and conducting hospital utilization analysis by sex and health determinants, including gender, must be emphasized.

Objectives: The purpose of this study is to provide a comparison of the benefits of reduction mammaplasty (RM) for women with heavy breasts often termed macromastia or breast hypertrophy (BH) surgery. The rationale is to provide information to allow decision-makers to make judgments about the cost-effectiveness of this intervention and make comparisons with other interventions which are commonly undertaken within publicly financed health-care systems.

Methods: Data from a previous outcomes study in Sweden is re-analyzed to derive quality of life measures, from which a mean level of benefit outcome is derived and a cost per quality-adjusted life year is calculated (cost per QALY).

Results: The low Cost per QALY suggests that reduction mammaplasty is cost-effective when compared with other treatments which are commonly undertaken.

Conclusions: The authors suggest that the evidence in favor of funding reduction mammaplasty is strong and that decision-makers review their policy in light of this new evidence.

This article provides a critical analysis of the impact of health technology assessment (HTA) on priority setting in The Netherlands. It describes the limited steering powers of the Dutch government; its complex interactions with insurers, health-care providers, and patients; and the role of HTA in this context as an attempt to rationalize the debate about cost-effectiveness issues. HTA has been drawn upon for decision making on the health insurance package. Also, HTA findings have been linked to the national guideline development programs of the medical community. However, these impacts by no means have been straightforward. We argue that the political nature of the priority-setting debate asks for a broader approach to what constitutes HTA, and how it should be drawn upon in priority setting. Suggestions are made on how to do justice to the social dynamics of decision making and the behavior of stakeholders in health-care systems.

Objectives: Promoting the adoption of clinical practice guidelines is a challenging task. Research shows that adopters' beliefs about guidelines and the process of their development are important predictors of guideline use. Our objective is to report on the development and refinement of an instrument designed to measure oncologists' assessments of guidelines in oncology.

Method: A theoretically derived instrument was drafted. Oncologists were asked to complete a questionnaire for each draft guideline they were asked to review. Factor analyses and multilevel modeling techniques were undertaken to explore the properties of the instrument and refine it.

Results: A total of 488 Ontario clinicians were sent 1,494 new questionnaires regarding 34 clinical practice guidelines produced between 1999 and 2002. A refined eighteen-item questionnaire with four stable factors that predicted 60 percent of the variance emerged. The factors are interpreted as guideline quality, applicability, acceptability, and comparative value. The four factors predicted oncologists' endorsements of draft guidelines and, with the exception of quality, predicted their intentions to use the guidelines. As expected, variation in the factor scores could be attributed more to the differences among the oncologist who completed the survey than to the differences among the guidelines themselves.

Conclusions:An instrument composed of four stable and theoretically relevant factors emerged. The findings support the hypothesis that beliefs about guideline attributes and development attributes relate to oncologists' endorsement of and intentions to use guidelines. Our next step is to link the responses of the survey with actual clinical behavior.

A systematic review and meta-analysis of randomized trials of nonpharmaceutical and nonhormonal interventions to reduce postnatal depression was carried out to summarize the effectiveness of interventions grouped in terms of the nature and timing of the intervention and whether the trial population was universal, selective, or indicated.

Objectives: Infliximab is a costly therapy for active Crohn's disease resistant to corticosteroids and immunosuppressive medication. The purpose of this study was to examine whether a treatment including infliximab (episodic re-infusions for relapse or maintenance therapy every 8 weeks) was relevant compared with conventional management (surgery and medical treatment without infliximab) for nonfistulizing resistant Crohn's disease.

Methods: We performed a life-time cost-utility analysis with an analytic Markov decision model from the perspective of the third-party payer system. Utility measurement using Standard Gamble was used to adjust the survival time for each health state of the disease. Direct costs were estimated from standard management based on expert opinion. A sensitivity analysis was conducted to gauge the effects of uncertainty in the values assigned to variables.

Results: The incremental effectiveness with infliximab therapy is .761 Quality-Adjusted Life Years (QALYs) for an added cost ranging from 48,478.79 euros to 596,990.35 euros, depending on treatment procedure. The incremental cost utility ratio expressed in euros per QALYs saved varied from 63,700.82 euros (episodic re-infusions) to over 762,245.09 euros (maintenance therapy).

Conclusions: Infliximab therapy could be cost-effective in the case of relapse treatment only, whereas the marginal cost-utility ratio exceeds conventional benchmarks for maintenance therapy. This analysis will be supplemented by conducting further randomized controlled trials and prospective observational study, focused on the costs of illness (direct and indirect), patient preferences, the disease's clinical course, and infliximab safety.

This article describes the development of health technology assessment (HTA) in Sweden, its influence on decision making, and its link with priority setting. Sweden has a well established governmental HTA body, the Swedish Council on Technology Assessment in Health Care (SBU), and an increasing number of regional/local HTA organizations. HTA has had an impact on clinical practice and is used to some extent in policy decisions. Several initiatives have now been taken to develop processes for open priority setting of health-care services. With the establishment of a new agency to undertake reimbursement decisions on pharmaceuticals, and greater patient and public involvement in decision making, it seems inevitable that HTA will play a more important role in priority setting in the near future.

Objectives: This study aimed to investigate whether evidence-based clinical practice in health care improves outcomes for patients, personnel, and/or organizations.

Methods: A systematic review of studies was conducted with various quantitative and qualitative methods up to the Spring of 2002. Protocols were used in quality assessment. Data synthesis is descriptive in a narrative form.

Results: Of 305 assessed articles, eight studies were included. The outcomes in the included studies were related to the experiences of patients and personnel and to organization concerning changed patient care and resource utilization. Because the included studies are heterogeneous in design, focus of research area, and scientific quality, the scientific foundation for the findings is weak. There is some support that evidence-based clinical practice guidelines, when put to use, improve outcomes (i) for patients—less likelihood of showing worsening of skin condition and disruption of skin condition improves more rapidly for infants; (ii) for personnel—support in daily work situation; and (iii) for organizations—decreased admission rates and length of stay, less resource utilization and reduced costs.

Conclusions: There is a need for further research as the findings are based on a rather limited number of studies. There is a tendency toward support for the idea that outcomes improve for patients, personnel, or organizations if clinical practice in health care is evidence-based, that is, if evidence-based clinical practice guidelines are used, although these findings could be specific to the settings and context of the studies reported in this systematic review.

Objectives: The increasing availability of information about health care suggests an expanding role for consumers to exercise their preferences in health-care decision-making. Numerous methods are available to assess consumer preferences in health care. We conducted a systematic review to characterize the study of women's preferences about health care

Methods: A MEDLINE search from 1965 to July 1999 was conducted as well as hand searches of the itshape Medical Decision Making Journal (1981–1999) and references from retrieved articles. Only original articles on women's health issues were selected. Information on thirty-one variables related to study characteristics and preferences were extracted by two independent investigators. A third investigator resolved disagreements. Qualitative and quantitative analyses were conducted to synthesize the data.

Results: Four hundred eighty-three studies were identified in the initial search. Seventy articles were selected for review based on title, abstract, and inclusion criteria. There was an increase in published articles and number of methods used to elicit preferences. White women were studied more than black women (p<.001). Preferences were mainly studied in outpatient settings (p<.005) and in the United States, United Kingdom, and Canada (83 percent). Preferences related to participation in decision-making were the most common (21 percent). Only 4 percent of the studies were performed to inform the debate for public policy questions. Willingness to pay was the method most used (11 percent), followed by category scaling (10 percent), rating scale (9 percent), standard-gamble (6 percent). Preferences for individual particular (opposed to sequential and health states) outcomes (68 percent), different treatments/tests (47 percent), and related to a treatment episode (31 percent) were addressed. Information regarding diseases, conditions, or procedures was given in 57 percent of studies. Information provided was mainly written (37 percent) and included positive and negative potential outcomes (67 percent). There is no relationship between the method or tool used for delivery information and the choice performed.

Conclusions: The literature on preferences in women's health care is limited to a fairly homogeneous population (white women from the United States, United Kingdom, and Canada). Additionally, use of utility-based measures to capture preferences has decreased over time while others methods (e.g., time trade-off [TTO], contingent valuation) have increased. Women's preferences are not necessarily uniform even when asked similar questions using similar tools. Little information on women's preferences exists to inform policy-makers about women's health care.

Objectives: To review the existing health economic literature on meningococcal disease vaccination.

Methods: A Medline search for economic evaluations of vaccination programs for meningococcal disease in developed countries was conducted. All identified studies were reviewed.

Results: Nine published studies were identified examining either mass vaccination during outbreaks or routine vaccination. Although net expenses were estimated in almost all studies, the resulting cost-effectiveness ratios varied widely. Vaccination of college-age students was found to be potentially cost-effective in Australia but not in the United States. With one exception, routine vaccination of children and adolescents in Europe was predicted to be cost-effective. Many simplifying assumptions were made, and important elements were often left out, in particular the potential for reduced transmission of disease.

Conclusions: The methods used and the vaccination strategies vary widely, and results do not provide strong grounds for making conclusions as to whether vaccination is cost-effective. Furthermore, in all instances, transmission of disease, changes in population carriage rates, and outbreaks are either ignored, dealt with using very broad simplifying assumptions, or are not necessarily generalizable to other settings. The analyses provide some insight into the potential cost-effectiveness of vaccination, but more importantly, they highlight areas requiring further study. Economic evaluations based on observed outcomes from recently implemented strategies would be helpful, as would more sophisticated health economic models. The choice of vaccination strategies cannot be based on the results of existing economic analyses.