Less developed countries (LDCs) are limited in medical resources. Medical technology and the management talent required to handle it play a particularly major role in their national health care and has significant economic, political, and ethical ramifications. This study of the assessment process of medical technology in the LDCs proposes a limited framework for the analysis of the major parameters involved, i.e., stakeholders, boundaries and constraints, goals and objectives, criteria to be met, performance measures, and measurement of performance. The importance of the intangible factors is elucidated.

Objectives: To describe the adoption and take up of thrombolytic agents for acute myocardial infarction since 1980 in England and compare use with the estimated ceiling of need.

Methods: Data on national sales and use of thrombolysis since 1980 (supplied by IMS Health) was used to draw an adoption and diffusion curve. The epidemiological ceiling of acute myocardial infarction, from hospital activity statistics, was modified to an estimated clinical need by accounting for diagnostic difficulty and contraindications using information from published surveys of thrombolysis use in the United Kingdom.

Results: There was a rapid uptake of thrombolytic agents in the first 2 years after availability in 1987, then a plateau, followed by a rise to a peak use in 1995. The shortfall in doses resulting from the difference between estimated ceiling of clinical need and doses purchased and provided in the 14 years since availability is estimated as 167,800 (95 percent confidence range 94,000 to 241,700).

Conclusions: Although there was a rapid initial uptake of thrombolysis in England, usage took 8 years to reach the ceiling of clinical need of 65 percent of patients with acute myocardial infarction, with many patients missing the opportunity to benefit. Monitoring of uptake of innovations known to be cost-effective is required to identify those developments that need additional stimulus for change to ensure that patients do not miss out on the opportunity to benefit.

Objective: To review the assessment of screening in the United Kingdom, focusing on three methods: mammography for breast cancer, screening for prostate cancer, and routine use of ultrasound in pregnancy.

Method: To review policy documents and published papers dealing with prevention and screening in the United Kingdom.

Results: Indicate that the United Kingdom has an active policy concerning the assessment of screening methods. Generally speaking, this assessment policy is part of the national program for health technology assessment (HTA). The government has given HTA an important place within health care in the United Kingdom, and prevention and screening is no exception to this general rule. The assessment of screening is now implemented through the National Screening Committee, established in 1997. The three issues reviewed in this paper have all been assessed within the context of the Department of Health. In the case of mammography, the assessment was done more than 10 years ago and was followed by a rational implementation of a national screening program for breast cancer. In the case of prostate cancer screening, two systematic reviews have concluded that screening should not be carried out. In general, this recommendation has been accepted in the United Kingdom. Use of ultrasound in pregnancy has been assessed by the National Screening Committee. This complex technology is difficult to assess, and the screening procedure is deeply embedded in clinical practice in the United Kingdom, so assessment has not had much impact on the frequency of screening.

Conclusion: HTA and the assessment of screening are well established in the United Kingdom. Policy is generally based on the assessments done, and practice generally follows the results of assessment. Assessment of screening is expected to become increasingly important in the United Kingdom during the next years.

Objectives: The aim of this study was to evaluate the success of search strategies in retrieving key documents for a technology assessment report (TAR) on a social care topic.

Methods: This study measured the differential yield of relevant studies from various information sources and evaluated strategies in different databases, with particular reference to capturing randomized controlled trials (RCTs) as a study design.

Results: A combination of four major databases would have found all thirty-two key references. One database alone would have found 78 percent, with another two each locating 59 percent. Sixteen percent of the trials were unique references. In non–health care databases, more sensitive search strategies would have resulted in a higher yield of relevant studies, in part due to inconsistent indexing and in part to attempts to restrict searches to RCTs. Although additional terms could be used to increase the sensitivity of the original strategies, this raises the question of trading off time against exhaustiveness, given the greater number of irrelevant references likely to be retrieved.

Conclusions: A successful search for evidence on this social care topic would be possible using a combination of MEDLINE, EMBASE, the Cochrane Library and PsycINFO, supplemented by only limited use of supplementary databases. In areas such as social care where evidence-based research is not yet well established, attempts to replicate searches based on study design do not seem to be advisable, although this may be an area for future research.

Objectives: The objectives of the study were to identify the current standards of clinical practice regarding prostate cancer screening in western Europe, Canada, and the United States, and to highlight major characteristics of current prostate cancer screening programs or patterns of practice.

Methods: We performed a semi-structured interview by means of a self-administered questionnaire sent by fax to 26 institutes pertaining to the International Network of Agencies for Health Technology Assessment.

Results: None of the countries surveyed had a formal national screening policy. Despite that, all the countries answering the questionnaire had discretionary, public-financed screening practices. Moreover, some scientific and professional organizations recommended population screening for prostate cancer, and few of the surveyed countries offered it as experimental practice within a randomized controlled trial. Survey results showed variation regarding screening policies, in particular test of choice, age cut-off points, and treatment prescribed for positive test results.

Conclusions: Despite the lack of conclusive evidence on the benefits of prostate cancer screening, the availability of simple and easy-to-administer tests has lead to an enormous variation on screening policies around the world. Practice variations also affect prostate cancer therapy.

Objectives: Gender as a social construct is a recognized health determinant. Because best practice in reporting health technology assessment (HTA) clearly specifies the need to appraise a technology's social impact within the target population, the extent to which gender issues are taken into account in HTA production is of interest, not only in light of equitable practices but also for reasons of effectiveness. The aim of this study is to provide a first assessment of the degree of gender sensitivity shown by HTA agencies around the world today.

Methods: The Web sites of sixty HTA agencies were analyzed. The consideration of gender aspects was specifically looked for in each agency's general mission statement, its priority setting process, and its methodological approach. Additionally, specific gender-oriented initiatives not belonging to any of the aforementioned categories were identified.

Results: Of the sixty agencies, less than half mention a commitment to addressing the social implication of health technologies. Only fifteen institutions make information on their priority setting principles available on their Web sites and gender was an issue in two of those cases. Data on methodology were obtainable online from18 agencies, two of which mentioned gender issues explicitly. Finally, gender-oriented initiatives were identified by thirteen agencies.

Conclusions: A gender-sensitive approach is apparently rarely adopted in current HTA production. Exceptional practices and relevant tools do exist and could serve as examples to be promoted by international collaborative networks.

The number of publications on health technology assessment (HTA) from Central, Eastern, and Southern Europe (CESE countries) is still low compared with the north and west of Europe. It is not surprising, as the idea of HTA originated from high-income Western economies and was afterward adopted by the south-eastern part of Europe, which mostly consists of middle-income countries. These CESE countries, with less capacity and experience with HTA processes, must deal with even tougher decisions on financing health technologies than north-western Europe. There may even be a lack of confidence to open discussions on their specific needs for HTA.

Current thinking about the methodology of health technology assessment (HTA) seems to be dominated by two fundamental tensions: [1] between maintaining a tight focus on quality-adjusted life-years and broadening its concern out to pay attention to a broader range of factors, and [2] between thinking of the evaluative dimensions that matter as being objectively important factors or as ones that are ultimately of merely subjective importance. In this study, I will argue that health is a tremendously important all-purpose means to enjoying basic human capabilities, but a mere means, and not an end. The ends to which health is a means are manifold, requiring all those engaged in policy making to exercise intelligence in a continuing effort to identify them and to think through how they interrelate. Retreating to the subjective here would be at odds with the basic idea of HTA, which is to focus on certain objectively describable dimensions of what matters about health and to collect empirical evidence rigorously bearing on what produces improvements along those dimensions. To proceed intelligently in doing HTA, it is important to stay open to reframing and refashioning the ends we take to apply to that arena. The only way for that to happen, as an exercise of public, democratic policy making, is for the difficult value questions that arise when ends clash not to be buried in subjective preference information, but to be front-and-center in the analysis.

Ethiopia’s commitment to achieving universal health coverage (UHC) requires an efficient and equitable health priority-setting practice. The Ministry of Health aims to institutionalize health technology assessment (HTA) to support evidence-based decision making. This commentary highlights key considerations for successful formulation, adoption, and implementation of HTA policies and practices in Ethiopia, based on a review of international evidence and published normative principles and guidelines. Stakeholder engagement, transparent policymaking, sustainable financing, workforce education, and political economy analysis and power dynamics are critical factors that need to be considered when developing a national HTA roadmap and implementation strategy. To ensure ownership and sustainability of HTA, effective stakeholder engagement and transparency are crucial. Regulatory embedding and sustainable financing ensure legitimacy and continuity of HTA production, and workforce education and training are essential for conducting and interpreting HTA. Political economy analysis helps identify opportunities and constraints for effective HTA implementation. By addressing these considerations, Ethiopia can establish a well-designed HTA system to inform evidence-based and equitable resource allocation toward achieving UHC and improving health outcomes.

The launch of innovative technologies has been credited with significant improvements in health indicators, but it comes at a high financial impact, and the value of certain innovations may not be well documented. Health technology assessment (HTA) is a universally established process to assess the incremental value of innovations. Despite its acknowledged value, almost one-third of the countries around the globe have not established yet a formal HTA in their health systems. The UAE is one of the pioneering countries worldwide in adopting innovative health technologies. This emphasizes the importance of exploring the key elements in the UAE’s journey toward the establishment of HTA. Our study aims to articulate an academic insight that can support the ongoing endeavors to establish the HTA in the UAE. This case study was guided by an analytical framework. Data was collected from document review and semistructured interviews, then analyzed by applying the codebook thematic analysis technique. The findings outline multiple facilitators and challenges in the perspective process, as they show a multidimensional interlink between all identified elements. Markedly, leveraging the role of specialized academia and building HTA genuine knowledge are the areas that need the most attention. The originality of this research is associated with analyzing the three health policy pillars: the context, actors, and content in a prospective HTA establishment process. The main practical implications generated from this study are supporting global health organizations, HTA policy entrepreneurs, and academics in improving their strategies and designing more effective HTA policy learning programs.

Objectives: The aim of this study was to explore whether wealth effects of health interventions, including productivity gains and savings in other sectors, are considered in resource allocations by health technology assessment (HTA) agencies and government departments. To analyze reasons for including, or not including, wealth effects.

Methods: Semi-structured interviews with decision makers and academic experts in eight countries (Australia, France, Germany, Italy, Poland, South Korea, Sweden, and the United Kingdom).

Results: There is evidence suggesting that health interventions can produce economic gains for patients and national economies. However, we found that the link between health and wealth does not influence decision making in any country with the exception of Sweden. This is due to a combination of factors, including system fragmentation, methodological issues, and the economic recession forcing national governments to focus on short-term measures.

Conclusions: In countries with established HTA processes and methods allowing, in principle, the inclusion of wider effects in exceptional cases or secondary analyses, it might be possible to overcome the methodological and practical barriers and see a more systematic consideration of wealth effect in decision making. This would be consistent with principles of efficient priority setting. Barriers for the consideration of wealth effects in government decision making are more fundamental, due to an enduring separation of budgets within the public sector and current financial pressures. However, governments should consider all relevant effects from public investments, including healthcare, even when benefits can only be captured in the medium- and long-term. This will ensure that resources are allocated where they bring the best returns.

Background: Health-related quality of life (HRQoL) is an important endpoint of many healthcare interventions. This study develops guidance on how to select appropriate HRQoL measures for inclusion in a clinical trial, given the purposes of the HRQoL measurement.

Methods: The guidance is based on a systematic literature review, discussions with members of the European Network for Health Technology Assessment (EUnetHTA) and two rounds of public consultation.

Results: A set of twelve recommendations was developed, addressing the requirements for HRQoL data for relative effectiveness assessment, for cost-utility analyses and for informing clinical decision making. Recommendations relate to the choice of the type of measure as well as to aspects such as measurement frequency, target population and presentation.

Conclusions: The purpose and context of HRQoL measurement is crucial for the relevance of the data obtained with a specific HRQoL measure. It is recommended to always include a generic HRQoL instrument in clinical trials to cover a wide range of possible future uses of the HRQoL data.

This paper describes the technical approach in the TUFFA (Technology Procurement for Disabled in Working Life) project and a model for cooperating areas of competence based on a holistic view of the individual's abilities, the environmental conditions at the work site, and technical solutions.

Objective: In this article, three preventive strategies—mammography screening for breast cancer, PSA screening for prostate cancer, and routine ultrasound in normal pregnancy—are discussed in the context of German health care.

Methods: Epidemiologic data and German studies evaluating different aspects of these preventive measures were identified and analyzed.

Results: Only a few studies could be identified that investigate these preventive measures. Despite sufficient evidence, in part derived from a German study, there is not yet a mammography screening program. In contrast, ultrasound in pregnancy is offered routinely, although there are controversies regarding the benefit of this practice. PSA screening is not offered as part of the screening program for prostate cancer. However, PSA tests as well as mammographies are done in large numbers in German ambulatory care—a practice that could be considered wild or opportunistic screening.

Conclusions: These case studies show that preventive programs and practices in Germany are not sufficiently based on sound evidence. The paucity of evaluation activities related to prevention in Germany is probably due to the low threshold to introduce new preventive programs into the German healthcare system in the past.

Objectives: Patient production losses occur when individuals’ capacities to work, whether paid or unpaid, are impaired by illness, treatment, disability, or death. There is controversy about whether and how to include patient production losses in economic evaluations in health care. Patient production losses have not previously been considered when evaluating medications for reimbursement under the U.K. National Health Service. Proposals for value-based assessment of health technologies in the United Kingdom created renewed interest in whether and how to include costs from a wider societal perspective, such as patient production losses, within economic evaluation of healthcare interventions.

Methods: A narrative review was undertaken of theoretical, ethical, and policy issues that might inform decisions that involve the normative question of whether or not to include patient production losses in economic evaluation.

Results: It seems difficult to reconcile the implications of including patient production losses with the objectives of a healthcare system dedicated to providing universal healthcare coverage without regard to patients’ ability to pay.

Conclusions: Tax payer funded healthcare systems may legitimately adopt maximands other than health gain, but these will be at the opportunity cost of less than maximum health gains.