Objectives: The aim of this study was to identify research and development on genetic testing to find out if research addresses important disease areas, how far it is from potential clinical use, and what consequences might arise for the prioritization of health technology assessment (HTA) activities. Also a horizon scanning methodology developed in Germany is demonstrated.

Methods: A systematic search on genetic testing was conducted in an innovation database (ZIM database). Based on a daily monitoring of literature and Internet sources, reports from 2003 up to 2005 were classified related to the type of innovation, the addressed disease categories, and the developmental phase of the technology. More detailed analyses for the most frequently addressed groups of diseases were conducted.

Results: From 239 relevant reports, 41 percent referred to neoplasms; 10 percent to diseases of the cardiovascular system; 9 percent to diseases of the nervous system; 7 percent to mental and behavioral disorders; and 5 percent to endocrine, nutritional, and metabolic diseases. A total of 69 percent of research is situated in basic preclinical research, 22 percent in clinical/experimental research, and 6 percent are genetic tests being used. Diagnostic applications were most frequently reported (28 percent), followed by therapeutic prediction (22 percent), preventive prediction (18 percent), pharmacogenetics (16 percent), and screening (16 percent).

Conclusions: Widespread diseases are frequently addressed in research. HTA on genetic testing might focus on innovations addressing neoplastic diseases (in particular breast, colon, and prostate cancers) and pharmacogenetic applications for therapeutic prediction. The horizon scanning approach seems useful in the early steps of HTA processes to identify emerging new technologies that might have significant impact on future health care.

Objectives: The observed posterior probability distributions regarding the benefits of surgery for otitis media with effusion (OME) with expected probability distributions, using Bayes' theorem are compared.

Methods: Postal questionnaires were used to assess prior and posterior probability distributions among ear-nose-throat (ENT) surgeons in the Netherlands.

Results: In their prior probability estimates, ENT surgeons were quite optimistic with respect to the effectiveness of tube insertion in the treatment of OME. The trial showed no meaningful benefit of tubes on hearing and language development. Posterior probabilities calculated on the basis of prior probability estimates and trial results differed widely from those, elicited empirically 1 year after completion of the trial and dissemination of the results.

Conclusions: ENT surgeons did not adjust their opinion about the benefits of surgical treatment of glue ears to the extent that they should have done according to Bayes' theorem. Users of the results of Bayesian analyses, notably policy-makers, should realize that Bayes' theorem is prescriptive and not necessarily descriptively correct. Health policy decisions should not be based on the untested assumption that health-care professionals use new evidence to adjust their subjective beliefs in a Bayesian manner.

The three-stage World Health Organization-International League of Associations for Rheumatology Community Oriented Programme for Control of Rheumatic Disease (WHO-ILAR COPCORD) is described. Stage I results from Indonesia and Brazil are presented. This is a needs-based approach that offers efficiency in large-scale survey research that aims to estimate the prevalence of rheumatic diseases. It saves human resources, time, and cost in the collection of epidemiologic data. Awaited with interest are the results of the next two stages of COPCORD, which involve the development of educational programs on rheumatic disease and the evaluation of their impact on the burden of illness.

Objectives: The objective of this study was to analyze and present the current state of the implementation of health technology assessment (HTA) in Slovenia, identify its advantages and challenges, as well as potential improvements and developments.

Methods: The HTA structure and processes were analyzed and comprehensively described according to relevant literature, official documents, and experiences of the author.

Results: The important steps in the development and implementation of an HTA system are presented through eight key elements: capacity building; HTA funding; HTA legislation and organizational structure; the scope of HTA implementation; decision criteria; quality, timelines, and transparency of HTA implementation; use of local data; and international collaboration. Based on the current situation, possible further developments are presented.

Conclusions: Currently, there is no systematic HTA in Slovenia; however, some basic use of HTA principles can be found in the decision making. The biggest deficiency in the HTA field is the lack of knowledge and systematic implementation. Legislation and guidelines for study appraisals are needed at decision-making levels. HTA principles across health technologies need to be unified along with a central HTA coordination office being set up to lead and establish priorities for HTA work.

The history of the European cooperation on health technology assessment (HTA) has reached an important milestone with the adoption of the European HTA Regulation (HTA R) 2021/2282 in Dec 2021 (1). Its publication in the Official Journal of the European Union means a lot to those of us who wish to give HTA a stronger role in supporting health policy in favor of sustainable healthcare systems in Europe. The HTA R was prepared well by the European Commission with an impact assessment on policy options for enhanced EU cooperation on HTA (2) in 2017, followed by 3 years of negotiations with Member States. Now the ratified document stipulates that the European Cooperation on HTA will be based on a legal mandate and no longer stay a voluntary project-based initiative. It also means sustainability, since a permanent Secretariat at the European Commission will be set-up under the HTA R.

Coronary bypass surgery developed as another in a line of surgical procedures dating back more than 60 years. The medical profession at first assessed this procedure with time-honored anecdotal techniques. Gradually, for a variety of reasons, improved methods of comparisons worked their way into assessments of bypass surgery. Randomized controlled trials met resistance but have been very influential. Assessment of percutaneous transluminal coronary angioplasty has benefited from the knowledge generated during the last 25 years, but clinicians have been slower to apply the most advanced techniques.

We performed an economic evaluation of HIV testing among intravenous drug users (IVDUs) in Italy using the analytical framework of cost-effectiveness analysis. A semi-Markov model was developed to calculate costs and life expectancy of a cohort of IVDUs with and without an annual HIV testing program. We also investigated the incremental cost-effectiveness of a hypothetical early treatment to prolong the life expectancy of HIV-infected asymptomatic subjects by 1 year. The testing program is cost saving in the low prevalence scenario (0.05), and costs L 14,000,000 (US $8,400) and L 55,800,000 (US $33,500) per year of life saved in areas of medium (0.3) and high (0.6) prevalence, respectively. The incremental cost-effectiveness of the hypothetical early treatment may compare favorably with other health care interventions. The program may be considered a cost-effective procedure in low and medium prevalence areas. Where prevalence is high, more evidence about the magnitude of the behavior change is needed. In these areas, the availability of an effective early treatment may become the economic rationale for implementing such a program.

Objectives: The objectives of this study were to analyze the current structure of the Turkish pharmaceuticals market to explain the latest developments and to offer some insight into the likely policy issues that this sector will face.

Methods: Systematic searches of the relevant Turkish and English research literature were made, using electronic databases in addition to written reports.

Results: The pharmaceutical industry in Turkey currently has eighty-seven manufacturing firms, eleven raw material manufacturers and thirty-eight importing firms. These add up to a total of 136 firms, 35 of which are driven by foreign capital, with 8 of these foreign-run firms having their own plants in Turkey. The industry employs approximately 19,000 personnel. In terms of growth, the value of pharmaceutical products in Turkey recently has exceeded that in Europe. In addition, per capita drug consumption levels are quite low compared with the Organisation for Economic Co-operation and Development and European Union countries. Major international players in the medical equipment and pharmaceutical products sector have also been opening offices in Turkey to reap the benefits of this rapidly evolving market.

Conclusions: The pharmaceutical industry in Turkey is quite advanced and diverse, with high quality, generic pharmaceutical products being manufactured as well as poor quality copies that have not been appropriately tested in terms of bioequivalence and bioavailability. The country faces a low level of drug consumption due to economic and cultural constraints compared with Western countries. Governmental control and regulations are key issues because the majority of drug purchases (70–80 percent) throughout the country are currently reimbursable through public sector agencies such as the Pension Fund and the Social Insurance Organization.

Proliferation of acute health care technology creates problems and benefits for nurses and patients. In this paper the impact of technology on the nursing work role is reviewed through the international literature. The thrust of the nursing literature has, not surprisingly, matured over time as the use of technology has become well established in the acute care environment, and three themes can be identified. The implications for acute care nurse specialists, including their educational needs, are set in context of the Australian health care system, with particular reference to the cardiac care environments.

Objectives: Prospect theory (PT) hypothesizes that people judge states relative to a reference point, usually assumed to be their current health. States better than the reference point are valued on a concave portion of the utility function; worse states are valued on a convex portion. Using prospectively collected utility scores, the objective is to test empirically implications of PT.

Methods: Osteoarthritis (OA) patients undergoing total hip arthroplasty periodically provided standard gamble scores for three OA hypothetical states describing mild, moderate, and severe OA as well as their subjectively defined current state (SDCS). Our hypothesis was that most patients improved between the pre- and postsurgery assessments. According to PT, scores for hypothetical states previously > SDCS but now < SDCS should be lower at the postsurgery assessment.

Results: Fourteen patients met the criteria for testing the hypothesis. Predictions were confirmed for 0 patients; there was no change or mixed results for 6 patients (42.9 percent); and scores moved in the direction opposite to that predicted by PT for 8 patients (57.1 percent).

Conclusions: In general, the direction and magnitude of the changes in hypothetical-state scores do not conform to the predictions of PT.

Objectives: This study aims to assess the impact of articles with very high reprint orders (“high-reprint articles”) by measuring their citation in the subsequent literature as compared with a control group of articles.

Methods: The twenty-one articles (published in the Lancet in 1998) with reprint orders of over 10,000 were matched with a control set of twenty-one articles with smaller reprint orders. The Science Citation Index was used to obtain the number of citations for each of the forty-two articles.

Results: The twenty-one high-reprint articles were cited 2,548 times; the mean number of citations was 121 (range, 3 to 499 citations per article). Five of the twenty-one high-reprint articles had more than 200 citations, but seven (33%) were cited twenty-five times or fewer. The twenty-one control articles were cited 986 times; the mean number of citations was forty-seven (range, 1 to 165). Fifteen (71%) of the twenty-one control articles were cited twenty-five times or fewer. Thirteen of the high-reprint articles were reports of randomized trials with a mean of 163 citations. In the control articles, six were reports of randomized trials with a mean of eighty-eight citations.

Conclusions: Articles with a high-reprint order were cited more frequently than other articles. However, some high-reprint articles were cited infrequently. If the size of a reprint order is related to the importance of an article, those articles with very high reprint orders may, therefore, be perceived as more important. Further research is needed to explore other aspects of the relative importance and impact of high-reprint articles.

Objectives: Previously in Finland, each municipality selected which methods to use in screening for fetal abnormalities. This resulted in practice variation and inequity. The national health technology assessment (HTA) office Finohta compared the methods and time frames available when screening for chromosomal and structural abnormalities. The assessment identified a need to discuss several value-laden questions before policy decisions could be taken.

Methods: The National Screening Committee (NSC) at the Ministry of Health and Social Affairs (MOH) formulated a statement based on the HTA report to inform policy makers. This article describes the steps in the policy process.

Results: The national screening committee organized an open forum to discuss the ethically relevant aspects of fetal screening, and a lengthy public discussion highlighted the viewpoints of various stakeholders. Based on the assessment, public discussion, and several committee meetings that heard further experts, the NSC formulated a conclusion based on equity of access. This also offered options for families unwilling to terminate a pregnancy due to fetal abnormality. The MOH sent the conclusion to a comment round, and the proposal was accepted with minor adjustments. The Ministry decided to unify the regulation of all public screening programs by one statute. The policy process lasted three years, and the methods to screen for fetal abnormalities will be unified after a further 3 years.

Conclusions: The assessment of screening programs for fetal abnormalities reached beyond its original mandate. The process of examining values behind screening resulted in a program that respects the differing objectives and ethical values of pregnant families, and to national legislation on screening programs.

Objectives: The Centers for Medicare and Medicaid Services (CMS) issues National Coverage Determinations (NCDs) for medical interventions expected to have a significant impact on Medicare, the health insurance program for US citizens aged 65 years and older and certain people with disabilities under the age of 65 years. The objective of this study was to evaluate NCDs issued from 1999 to 2013 to identify key trends, and to discuss implications for future CMS policy.

Methods: We used the Tufts Medical Center Medicare National Coverage Determination Database to examine characteristics of NCDs from 1999 through 2013. We examined various characteristics of NCDs, including: whether the intervention under review is used for prevention or treatment of disease, the type of intervention considered, evidence limitations cited by CMS, and coverage determination outcome. We evaluated longitudinal trends in categorical and continuous variables in the database, using Cochran-Armitage trend tests and linear regression, respectively.

Results: We found that NCDs increasingly focus on preventive care (p = 0.072), pertain to diagnostic imaging (p = 0.033), and evaluate health education/behavioral therapy interventions (p = 0.051). CMS increasingly cites the lack of relevant outcomes (p = 0.019) and the lack of applicability of study results to the Medicare population (p < 0.001) as evidence limitations. CMS less often restricts coverage to certain population subgroups in NCDs (p < 0.001), but increasingly applies coverage with evidence development policies (p < 0.001).

Conclusions: Identified trends reflect broader changes in Medicare as CMS shifts its focus from treatment to prevention of disease, addresses potentially overutilized technologies, and attempts to issue flexible coverage policies.

In-vitro fertilization (IVF) is a relatively recent approach to overcoming human fertility problems. This study explored factors in the diffusion of IVF in England and in the Netherlands. Many factors were common to the two countries. Governments in both countries have been passive, apparently wishing to avoid entering a controversial field. Technology assessment has played little part in the diffusion process in these two countries.

Objectives: The practical significance of health technology assessment (HTA) in policy decisions or clinical practice has been challenged. Possibly, problem definitions underlying HTA do not concur sufficiently with the problem definitions held by policy makers or clinicians. We performed an in-depth case study on mebeverine, a drug prescribed to patients with irritable bowel syndrome, to explore this hypothesis.

Methods: The theoretical framework was provided by the theory of argumentative policy analysis. We analyzed documents and held semistructured interviews to collect data. We reconstructed interpretative frames to analyze actors' argumentation.

Results: The funding and usage problems relating to mebeverine were ill-structured. Actors disagreed on the information needed and the norms at stake. As a result, the problem definition shifted, and the resulting problem definitions failed to correspond with the problems perceived by the target populations.

Conclusions: To ensure that future studies on healthcare problems are useful, it is imperative that policy makers take the problem definitions of potential users into account.

Health technology assessment (HTA) agencies are considering adopting a lifecycle approach to assessments to address uncertainties in the evidence base at launch and to revisit the clinical and economic value of therapies in a dynamic clinical landscape. For reassessments of therapies post launch, HTA agencies are looking to real-world evidence (RWE) to enhance the clinical and economic evidence base, though challenges and concerns in using RWE in decision-making exists. Stakeholders are embarking on demonstration projects to address the challenges and concerns and to further define when and how RWE can be used in HTA decision making. The Institute for Clinical and Economic Review piloted a 24-month observational RWE reassessment. Key learnings from this pilot include identifying the benefits and challenges with using RWE in reassessments and considerations on prioritizing and selecting topics relevant for RWE updates.

Objectives: The aim of this study was to describe the history and present situation with health technology assessment (HTA) in Israel.

Methods: The method used in this study was a historical analysis based mainly on the knowledge of the authors, but supplemented by the published literature.

Results: HTA originated in Israel as a centralized function conducted under the auspice of research, developing into an active multidisciplinary center. Throughout the expansion of the field, HTA was performed in affiliation with several local and international bodies, while providing direct and indirect support at the national level. Today, mainly as a result of vigorous dissemination of the principles, methodology and tools for HTA by the Israeli Center for Technology Assessment in Health Care (ICTAHC), this discipline is increasingly a decentralized activity conducted by a great variety of institutions. Israeli health policy decisions are increasingly based on the results of HTA.

Conclusions: ICTAHC's role and functioning has expanded since its beginnings. HTA has become an important part of health care in Israel.