Objectives: To explore and test methods for the operation of a national Early Warning System (EWS) in Denmark and to support decision making by the Danish Centre for Evaluation and Health Technology Assessment on this issue.

Methods: On the basis of literature reviews, information from members of EuroScan, and supported by clinical experts and stakeholders, existing methods were adapted and new methods were developed as part of a feasibility study.

Results: Approximately 200 technologies in 30 specialties were identified on the basis of information by EuroScan. A new instrument was developed to distinguish between important and unimportant technologies (filtering). Clinical experts in six specialties applied the instrument to sixty-two technologies in their respective fields, of which nine (15%) were judged potentially important for the Danish health care system. For priority setting, adapting a Dutch instrument to the Danish context was discussed. In principle, the instrument was acceptable, but several changes were proposed, for example, relating to the decentralized structure of the Danish health care system. For early assessment, the format and methods applied by SBU and Canadian Coordinating Office for Health Technology Assessment (CCOHTA) were compared and applied to pharmaceuticals (glitazones in treatment of type 2 diabetes mellitus) and a procedure (embolization of uterine fibromas). Given the main target group of the Danish EWS, local decision makers, the CCOHTA format was preferred.

Conclusions: The findings of the study have laid the foundation for an EWS using appropriate methods adapted to local circumstances. On the basis of the findings, a decision was made to start an EWS.

Objectives: To describe how Lithuania is attempting to develop health technology assessment (HTA) structures.

Methods: The case study of the history of development of HTA in Lithuania is presented.

Results: Historical steps of HTA development are as follows: in 1993, a few conferences on HTA; eight people were trained in Sweden at SBU; the book First Steps of HTA in Lithuania (5) was issued together with SBU in 1993; participation in the International Society of Technology Assessment in Health Care (ISTAHC) conferences; participation in development of training courses and European networks of HTA; new people in HTA were trained in health accreditation service, Sickness Fund, and Ministry of Health. The major step was establishment of an evidence-based medicine library.

In 1994, Article 54 in the Health Care System Law, which declares that the use of healthcare technologies that have not been assessed or approved shall be prohibited, except in cases provided by law, was passed. The procedure of healthcare technologies assessment and approval was to be established by the Ministry of Health Care. A policy of HTA was approved with the program for HTA in 1999 in the Ministry of Health. Currently, enthusiasts of HTA fully realize that technology assessment is a developing frontier for creative and constructive thinking from all disciplinary view points.

Conclusions: Unfortunately, in this country, there is still a very small demand for HTA reports from the decision-maker's side. Hopefully joining the network of European Union Network for Health Technology Assessment (EUnetHTA) will give a new challenge for further policy development.

Objectives: This study aims to analyze the key factors considered for the first application of the National Committee for the Evaluation of Medical Devices (CNEDiMTS) for achieving reimbursement through registration in the list of products and services qualifying for reimbursement (LPPR).

Methods: All the appraisals studied on medical devices (MD) for first inclusion in the LPPR during 2011 and 2012 were retrieved from the French National Authority for Health or Haute Autorité de santé (HAS) Web site. A list of relevant factors was analyzed for each included opinion, followed by univariate and multivariate analyses to highlight the key factors that impacted the expected benefit (EB) provided by HAS.

Results: A total of 151 appraisals were included in the study. Of them, 94 (62 percent) were granted with sufficient EB. The manufacturers were mostly from the United States (36 percent), while most of the applicants were from France (84 percent). After adjusting for other retrieved factors, it was observed that MDs complying with the technical standards, requests supported by opinion(s) from previous generation of MD, and the presence of recommendations or guidelines had more probability to obtain a sufficient EB. A lower probability was related to MDs supported by low-quality studies and with no specific health public benefit.

Conclusions: Our results confirmed that manufacturers seeking reimbursement should be aware of the expectations of the health authorities (level of evidence, technical standard, etc.) and foresee their plan of sending requests for funding so that they can provide evidence of good quality.

Review of a large data base on 76 patients who had suffered head injuries and whose metabolic changes were being studied demonstrated the variability of their neurological courses and the importance of considering confounding factors in the analysis of such a group. It was apparent that many such patients continue to change neurologically and functionally for long periods of time, and that their ultimate outcome cannot be determined for at least 1 year. The study demonstrates the inherent complexity of a group of patients with head injuries and the need to use sophisticated statistical tools and a computer to demonstrate whether apparent trends are statistically valid in light of confounding factors and variabilities. Failure to take this complexity into account seems to be a major factor in many of the ongoing controversies in research on head injuries. A possible solution to the problem of potential biases introduced by lost patients would be to develop a method to use government records to obtain current addresses for patients involved in federally funded research.

The use of upper gastrointestinal (Gl) fiberoptic endoscopy has spread at different times and rates in Japan than in the United States. Factors that explain this disparity and its effects on patient outcomes are reported. This essay outlines Japanese data in gastroenterology, giving an account of the resources and time that were spent on the development of upper Gl endoscopy in Japan. It also draws implications for the assessment of endoscopy for populations at high risk for gastric cancer.

This paper provides a critical overview of several strategies and mechanisms that have been employed by the Program for Appropriate Technology in Health over the past decade to address the unmet needs for health technologies in the developing world. Partnerships between public and private-sector organizations are emphasized in order to share risks, encourage efficiency, and ensure the availability of priority products for health care in resource-poor settings. Incentives for the involvement of the commercial sector, the means to protect the interest of the public sector, and the role of bridging organizations are discussed in the light of the shifting goals of the public sector.

Clinical genetics services have become an integrated part of health care in nearly all European countries. The emphasis has been on postnatal cytogenetic, biochemical, and DNA diagnosis of congenital disorders, carrier detection, genetic counseling, and prenatal diagnosis. Use has been satisfactory, and very few ethical problems have arisen, apart from moral objections against abortion by minority groups. The progress of human gene mapping is associated with new perspectives in clinical genetics and will enable the identification of people at risk of major adult diseases. This prospect has caused some concern about psychosocial and ethical issues that are being dealt with in different ways in various postindustrial societies. In future decades, however, 95% of the world's population increase will occur in developing countries. In most of these countries, a low per capita income, female illiteracy, low rates of contraceptive use, teenage pregnancy, and religious and traditional cultural factors are major complications of implementing genetic services at a global level. There are, however, some exceptions, which are discussed.

This paper examines the characteristics of the process of innovation as applied to a range of contraceptive technologies. Whereas the understanding of how and why innovation works or does not work has grown in the past few decades in such professional fields as electronics, aviation, and optics, only the first attempts are currently under way in medicine. Borrowing from other fields, this paper proposes a theoretical underpinning to the process of innovation as it would apply to the development of medical technology. Subsequently, it documents this process with regard to contraceptive technology (oral contraceptives, injectables, intrauterine devices, implants, and surgical contraception), providing a framework of first-, second-, and third-generation definitions of development. A number of observations about the importance of certain supply- and demand-side determinants of the direction and rate of medical innovation conclude the essay.

Analysis of epidemiologic studies reveals that even with advances in preventive dentistry, edentulism continues to be a pressing problem especially in a rapidly expanding senior population. As an alternative to traditional removable dentures, dental implants can provide fixed support for crowns and bridges. A recent National Institutes of Health Consensus Development Conference revealed significant growth in implant technology and established that, although a complex treatment alternative, implants can function for 10 years or more. Continued development in basic and clinical research, federal regulations, professional education, public awareness, insurance, and marketing will shape the future of the field.

Objectives: There is a growing volume of literature on health economic evaluation, with this form of analysis becoming increasingly influential at the decision-making level worldwide. The purpose of this study was to review the current state of health economic evaluation in Greece, with a view to uncovering reasons why its use in this country is limited.

Methods: A search of the NHS Economic Evaluation Database was undertaken. The search included cost, cost-of-illness, cost-minimization, cost-effectiveness, cost-consequences, cost-utility, and cost-benefit analyses and was narrowed only to Greek authors undertaking solo or joint health economic evaluation in Greece.

Results: The search revealed that, in Greece, very little health economic evaluation has been undertaken. The main reason for the lack of interest is that the current chaotic healthcare system structure and financing does not provide the appropriate incentives to stimulate a powerful interest in this type of research. This condition is a result of the lack of a long-term national health policy and the hesitation of the present and past Greek governments to date to proceed to large-scale reforms because of political considerations. The Greek governments have also been content with the good health indicators being achieved.

Conclusions: Even if it is accepted that good health prevails in Greece, slower economic growth rates, an ageing population, and the continuous immigration will place increasing pressure on healthcare resources and will necessitate a more rational use of these resources. Health economic evaluation, by weighing benefits against costs, therefore, has an important role to play.

Objectives: Due to potential advantages (e.g., using all available evidence), Bayesian methods have been proposed to assist healthcare decision making. This review provides a detailed description of how Bayesian methods have been applied to economic evaluations of patient level data. The results serve both as a reference and as a means by which to examine the appropriate application of Bayesian methods to inform decision making.

Methods: MEDLINE, EMBASE, and Cochrane Economic Evaluation databases were searched to identify studies, published up to November 2007, meeting three inclusion criteria: (i) the study conducted an economic evaluation, (ii) sampling uncertainty was incorporated using Bayesian methods, (iii) the likelihood function was informed by patient level data from a single source. Data were collected on key study characteristics (e.g., prior distribution, likelihood function, presentation of uncertainty).

Results: The search identified 366 potentially relevant studies, from which 103 studies underwent full-text review. Sixteen studies met the inclusion criteria. Half of the studies used uninformative priors; most studies incorporated the potential dependence between costs and effects, and presented cost-effectiveness acceptability curves. Results were sensitive to changes in the priors and likelihoods.

Conclusions: Limited use of informative priors, among the included studies, gives policy makers little guidance on one of the main benefits of Bayesian methods, the ability to integrate all available evidence to capture the uncertainty inherent in decision making.

Earlier activities on health technology assessment (HTA) started in Spain around 1984, with the creation of a National Advisory Board on HTA, and the development of national and regional HTA organizations in the early 1990s. In 2012, the Spanish Health Ministry established the Spanish Network for Health Technology Assessment of the National Health System (RedETS); funded at national level and including all public HTA organizations at national and regional levels. RedETSis focused on the assessment of nondrug health technologies to inform the revision (approval and funding or disinvestment) of the Benefit Portfolio of the Spanish NHS. In parallel with European Network for Health Technology Assessment (EUnetHTA), RedETS has been setting-up and sharing common procedures and methodological guidelines to ensure effective cooperation and mutual recognition of the scientific and technical production in HTA. The output of RedETS is fifty to sixty annual reports, including the production of full HTA reports, Clinical Practice Guidelines, methodological guidance reports, relative effectiveness assessments, tools to support shared decision making between patients and healthcare professionals, and monitoring studies. The HTA assessments requested by the Regional Health Authorities are the biggest component of the annual RedETS working plan. These assessment needs are identified according to a yearly process and prioritized by a Commission composed of representatives from all Spanish regions with the aid of the PRITEC tool. The objectives of this study are to report and update the normative and organizational state of HTA in Spain; describing noteworthy advances witnessed over the past 10 years, as well as discussing existing challenges.

Objectives: The aim of this study was to examine the potential cost-effectiveness of calcium chemoprevention post-polypectomy as a substitute or adjunct for surveillance.

Methods: We constructed a Markov model of post-polypectomy adenoma recurrence and colorectal cancer (CRC) development, calibrated to data from prospective chemoprevention trials of fiber, calcium, antioxidants, and aspirin. We modeled four scenarios for 50-year-old patients immediately after polypectomy: (i) natural history with no further intervention; (ii) elemental calcium 1,200 mg/day from age 50–80; (iii) surveillance colonoscopy from age 50–80 every 5 years, or 3 years for large adenoma; (iv) calcium + surveillance. Patients were followed up until age 100 or death.

Results: Calcium was cost-effective compared to natural history ($49,900/life-year gained). However, surveillance was significantly more effective than calcium (18.729 versus 18.654 life-years/patient; 76 percent versus 14 percent reduction in CRC incidence) at an incremental cost of $15,900/life-year gained. Calcium + surveillance yielded a very small benefit (0.0003 incremental life-years/patient) compared with surveillance alone, at a substantial incremental cost of $3,090,000/life-year gained.

Conclusion: Post-polypectomy calcium chemoprevention is unlikely to be a reasonable substitute for surveillance. It may be cost-effective in patients unwilling or unable to undergo surveillance.