HTA can be described as a research-based, practice-oriented assessment of relevant evidence and knowledge on the direct and intended effects of healthcare technologies, as well as the indirect and unintended consequences (4). It is also viewed as a multidisciplinary field of policy analysis that studies the medical, ethical, social, and economic implications of the development, diffusion, and use of a health technology (5).

Adjuvants increase cell-mediated and humoral immune responses to specific antigens. Used with recombinant viral antigens, they can elicit the production of T lymphocytes that lyse target cells, expressing the antigen in a genetically restricted fashion. Adjuvants can augment the production of interferon-gamma, thereby favoring the production of protective antibody isotopes, such as immuno-globulin G2a in the mouse. Modern adjuvants display the efficacy of Freund's complete adjuvant without its side effects. One such adjuvant is Syntex adjuvant formulation, a synthetic analogue of muramyl dipeptide in a microfluidized squalane/squalene-in-water emulsion. Monophosphoryl lipid A in a similar lipid emulsion is also effective. Immune-stimulating complexes of saponin and antigens elicit potent cell-mediated and humoral responses. A purified saponin component has adjuvant activity with reduced side effects; liposomes also can have adjuvant activity. Administering antigens in adjuvants can overcome low responsiveness in very young and old experimental animals and in those that are genetically low responders. Adjuvants are likely components of a new generation of recombinant and subunit vaccines.

When setting priorities for health, there is broad agreement that a range of social values and ethical principles beyond clinical and cost-effectiveness matter, but exactly how health technology assessment (HTA) should account for a broader set of criteria remains an area of ongoing debate. In light of this, we welcome a recent review paper by Baltussen et al. evaluating the potential of different multi-criteria decision analysis (MCDA) approaches to enable HTA agencies to incorporate a broader set of values in their appraisals. The authors describe three approaches to MCDA—qualitative MCDA, quantitative MCDA, and MCDA with decision rules—laying out their relative advantages and disadvantages and providing recommendations for how they can best be implemented. While we endorse many of the authors' assessments and conclusions, including the critical role of deliberation in any MCDA approach and the undertaking of qualitative MCDA at a minimum, we take a stronger position regarding the flaws of quantitative MCDA and strongly caution against it. We find quantitative MCDA antithetical to at least two of the ways MCDA is intended to improve HTA recommendations: (i) enhancing quality and (ii) promoting transparency. Quantitative MCDA may mask the complex tradeoffs that exist within and between decision criteria and remain generally inaccessible to those who are not well-versed in its technical methods of appraisal. We advocate for a predominantly qualitative approach to MCDA appraisal centered around deliberation and supplemented with decision aids to help account for health opportunity costs.

There are several techniques for estimating health state utility values, each of which presents pros and cons in the context of rare diseases (RDs). Direct approaches (e.g. standard gamble and time trade-off) may be too demanding for patients with RDs, since most of them affect young children or cause cognitive impairment. The alternatives are using “vignettes” that describe hypothetical health states for the general public, which may not reflect the heterogeneous manifestations of RDs, or multi-attribute utility instruments (i.e. indirect techniques), such as EQ-5D, which may be less sensitive in capturing the specificities of RDs. The “rule of rescue” approach is a promising alternative in RDs, since it prioritizes identifiable patients with life-threatening or disabling conditions. However, it raises measurement challenges and ethical issues. Furthermore, the literature reports on relevant implications of choosing a technique over others for health technology assessment, which should be considered in relation to individual RDs.

Objectives: The aim of this study was to review 5 years of activity from a new system devised by the National Institute for Health and Care Excellence (NICE), for assessing medical devices and diagnostics aimed at identifying and speeding adoption of technologies with clinical and cost advantages, compared with current practice in the United Kingdom healthcare system.

Methods: All eligible notified technologies were classified using the Food and Drug Administration and Global Medical Device Nomenclature nomenclatures. Decisions about selecting technologies for full assessment to produce NICE recommendations were reviewed, along with the reasons given to companies for not selecting products.

Results: Between 2009 and 2014, 186 technologies were notified (46 percent therapeutic and 54 percent diagnostic). Thirty-nine were judged ineligible (no regulatory approval), and 147 were considered by an independent committee. Of these, eighty (54 percent) were not selected for full assessment, most commonly because of insufficient evidence (86 percent): there were uncertainties specifically about benefits to the health service (54 percent), to patients (39 percent), and about cost (24 percent). The remaining 67 were selected and assessed for Medical Technology guidance (52 percent) (noninferior and/or lower cost consequences than current practice), for Diagnostics guidance (43 percent) or other NICE recommendations about adoption and use. Classifying technologies by two different systems showed no selection bias for any technology type or disease area.

Conclusions: Identifying new or under-used devices and diagnostics with potential benefits and promoting their adoption is important to health services in the United Kingdom and worldwide. This new system offers a means of fostering both uptake and further research. Lack of research data on new products is a major obstacle to evaluation.

Technological aspects and early clinical experiences are arousing great enthusiasm over magnetic resonance imaging (MRI). However, influences such as regulation, reimbursement, and increasing competition also are playing important roles in determining the diffusion of this new technology. Of these considerations, competition among providers seems the most important. Competition related to MRI is manifested as direct competition over MRI services, using MRI to improve a provider's strategic position and competition among specialties. In making decisions concerning MRI acquisition and operation, providers are drawing upon their experiences with computed tomography (CT) to help them determine when would be the best time for acquisition, how to decide whether acquisition is appropriate, and how best to acquire, operate, and market the technology.

This article describes one approach to assessing the effects of perinatal care–that adopted by the National Perinatal Epidemiology Unit in Oxford, England. The unit's research has been based primarily on a combination of simple, descriptive analyses of observational data and statistically robust analyses of evidence derived from randomized controlled trials.

Objectives: In the past decade, there has been a growing interest in health technology disinvestment. A disinvestment process should involve all relevant stakeholders to identify and deliver the most effective, safe, and cost-effective healthcare interventions. The aim of the present study was to describe the state of the art of health technology disinvestment around the world and to identify parameters that could be associated with the implementation of disinvestment programs.

Methods: A systematic review of the literature was performed from database inception to November 2014, together with the collection of original data on socio-economic indicators from forty countries.

Results: Overall, 1,456 records (1,199 from electronic databases and 257 from other sources) were initially retrieved. After analyzing 172 full text articles, 38 papers describing fifteen disinvestment programs/experiences in eight countries were included. The majority (12/15) of disinvestment programs began after 2006. As expected, these programs were more common in developed countries, 63 percent of which had a Beveridge model healthcare system. The univariate analysis showed that countries with disinvestment programs had a significantly higher level of Human Development Index, Gross Domestic Product per capita, public expenditure on health and social services, life expectancy at birth and a lower level of infant mortality rate, and of perceived corruption. The existence of HTA agencies in the country was a strong predictor (p = .034) for the development of disinvestment programs.

Conclusions: The most significant variables in the univariate analysis were connected by a common factor, potentially related to the overall development stage of the country.

Dental amalgam—a mixture of elemental mercury and a silver-dominated metal alloy—has been the most widely used dental filling material for well over a century. Alternative materials exist but are not well suited for some important applications, and all are more expensive than amalgam. The toxic effects of occupational mercury exposure have long been known, but it was not until about 1980 that serious consideration was given to the possibility that mercury vapor escaping from amalgam fillings might be affecting health, specifically producing subtle effects on the central nervous system. Such effects have been reported among dentists and other dental personnel, whose exposures are well below industrial levels but above those from fillings alone. No large studies have been completed that examine the effects of mercury exposure from dental amalgam fillings. In the face of inadequate evidence on the possible risks of dental amalgam, countries have reacted disparately. Sweden is phasing out amalgam entirely, possibly by the end of 1997. Germany has produced guidelines for limiting its use, other countries have signaled their intention to reduce it, and others—the United States and Canada—have studied the matter but taken no action. Policy differences within Europe have made dental amalgam a test case for the European Community's new medical device regulations. Relatively little epidemiologic research has been initiated to try to answer the question of dental amalgam's possible health effects. An international effort to define and carry out a research agenda to guide public policy is called for.

The author contends that the diffusion and use of modern medical technologies has had a profound impact on the hospital environment, the doctor-patient relationship, and the humanity of the patient. On these grounds the author argues for a rigorous, comprehensive, and ongoing assessment of diagnostic and therapeutic technologies. He stresses the importance of developing standards by which to judge the human and economic impact of particular technologies. These studies would decrease the inappropriate use of medical technology and would provide guidelines to improve current use.

Objectives: This preliminary study had two objectives: a) charting the considerations relevant to decisions about acquisition of new medical technology at the hospital level; and b) creating a basis for the development of a research tool that will examine the function of the Israeli health system in assessment of new medical technologies.

Methods: A comprehensive literature review and in-depth interviews with decision makers at different levels allowed formulation of criteria considered by decision makers when they decide to purchase and use (or disallow the use) of new medical technology. The resulting questionnaire was sent to medical center directors, along with a letter explaining the goals of the study. The questionnaire included 31 possible considerations for decision making concerning the acquisition of new medical technology by medical centers. The interviewees were asked to indicate the relevance of each consideration in the decision-making process.

Results: The most relevant criteria for the adoption of new technologies related to the need for a large capital investment, clinical efficacy of the technology as well as its influence on side effects and complication rates, and a formal approval by the Ministry of Health. Most interviewees stated that pressures exerted by the industry, by patients, or by senior physicians in the hospital are less relevant to decision making. Very small and usually not statistically significant differences in the ranking of hospital directors were found according to the hospitals' ownership, size, or location.

Conclusions: The present study is a basis for a future study that will map and describe the function of hospital decision makers within the area of new technology assessment and the decision-making process in the adoption of new healthcare technologies.

To explore the treatment of patients with early localized prostatic carcinoma, we surveyed the departments of urology and general surgery in Denmark, Finland, Norway, and Sweden. Clinical policies and physicians' attitudes toward the radical treatment options varied widely between the countries. A correlation seems to exist between practice patterns and national attitudes toward special technologies.

The article “Key principles for the improved conduct of health technology assessments for resource allocation decisions” presents fifteen principles for health technology assessment. Many of these cannot be disputed, and application of the principles as stated would undoubtedly improve HTA as it is developing in the world at large. My question is, are these the most important principles? The document does not really try to answer this question.

This study examines the parameters crucial to cost-effectiveness of universal hepatitis B immunization in India. An incremental cost-effectiveness analysis was done using a decision tree (Markov model) to follow up a hypothetical cohort of 100,000 newborns for the effects of hepatitis B acquired vertically at birth. The measure of effectiveness was disability-adjusted life-years gained. Uncertainty analysis and Scenario analysis were done using Latin hypercube sampling. Hepatitis B endemicity is the most important factor, followed by the cost of vaccine. Other factors of some influence are vaccination coverage, vaccine efficacy, HBeAg positivity, and vaccine wastage.

Objectives: To examine the cost-effectiveness of pediatric cochlear implantation over time.

Methods: A prospective study based on ninety-eight children implanted between 1989 and 1996 at Nottingham's Paediatric Cochlear Implantation Programme, UK. The influence of outcomes and other variables on total costs was examined using multivariate regression analysis.

Results: Having controlled for potential confounding variables, total cost was negatively related to year of implant and positively related to the number of hours of rehabilitation (p=.000).

Conclusions: Having controlled for outcomes (Categories of Auditory Performance and Speech Intelligibility Rating), the cost-effectiveness improved over time. This finding may be due to a learning curve and have policy implications.

Background: Mental illness constitutes a large proportion of the burden of disease in Zambia. Yet mental health services at the primary care level are either provided in a fragmented manner or are lacking altogether.

Methods: A literature review focused on terms including mental health and primary care and strategic options were analyzed.

Results: From the analysis, two options were considered for integrating mental health into primary health care. An incremental option would start with a pilot project introducing mental health services into primary care with a well-designed evaluation before scaling up. One key advantage of this option is that it is possible to make improvements in the plan, if needed, before scaling up. A comprehensive option would entail introducing mental health services into primary care in all nine provinces of Zambia. In this option, scaling up could occur more rapidly than an incremental approach.

Conclusions: Strategies to implement either option must address several barriers, including insufficient funding for mental health services, inadequate mental health indicators, lack of general public awareness of and social stigma attached to mental illnesses and mental health care not being perceived as cost-effective or affordable.

Objectives: To review the economic evaluations (EEs) done in Italy by Italian authors, following a common scheme to allow some comparisons of the studies selected and with the international reviews.

Methods: We selected all the original studies published by Italian authors (in Italian or English) in national and international journals. The period considered was January 1994 to December 2001. Both full and partial economic evaluations were included. Three international databases were interrogated: MEDLINE, Embase, and HealthStar; further articles were added from the internal database of our center (CESAV), which also classifies Italian local publications and journals specialized in health economics.

Results: A total of ninety-nine studies were reviewed. More than half of the fifty-seven full EEs focused on drugs as type of intervention (n=38), followed by diagnostic screening (n=7). The NHS viewpoint was the most used (n=55 studies), followed by that of society (n=27) and hospitals (n=12). Sixty-eight studies only analyzed direct costs and twenty-nine included both direct and indirect costs. Twenty-five of the thirty-eight pharmacoeconomic full EEs were sponsored by companies. In sixteen of the twenty-five sponsored studies, the sponsor's products were the dominant alternative.

Conclusions: The review showed that, in Italy, like elsewhere, there is a gap between theory and practice in EEs, and sponsors can considerably affect the results of EEs.

Greater access to web-based information on health-care interventions might result in greater participation by patients in care and self-care decisions, but only improve health outcomes if the indicated actions produce the intended benefits. Unbiased research on benefits and harms of health information can provide a basis for evidence-based patient information systems.

Objectives: To evaluate the quality of the information content on bone-mineral density (BMD) testing posted on consumer health websites (CHWS).

Methods: Five popular engines (Yahoo, MSN, AOL, Lycos, and Go.com) were used to search for patient information on bone densitometry. The fifteen websites that supplied relevant content and were identified by three of the five search engines were selected in order of popularity of the search engine and primacy of placement. Six BMD reports from health technology assessment (HTA) organizations were used as a standard of scientific quality. These were identified from the HTA Database at York University United Kingdom and published between 1996 and 2001. Content was extracted from both document types, and these sets were compared independently by two reviewers.

Results: The majority of CHWS identified by popular search engines do not disclose the limited capacity of BMD to discriminate between low-risk individuals and those who will suffer future fractures. CHWS generally present BMD testing as quick, painless, noninvasive, and as being recommended, based on risk factors that are widespread among the general public. BMD testing information is prominently paired on CHWS sites with information on osteoporosis, with an emphasis on “silent disease” and the devastating consequences of advanced disease. Sponsors of CHWS sites are frequently either providers of BMD testing or companion drugs, and consequently in a position of conflict of interest with regard to decisions to undergo BMD testing. HTA organizations have no documented conflict of interest, nor do they invoke emotional arguments. Their approach is to emphasize the effects of testing on populations, on the basis of referenced research findings.

Conclusions: Content analysis demonstrates the omissions and divergence of information on BMD testing available to consumers on the Internet, as compared with HTA reports. The content of HTA reports has undergone rigorous systematic and peer review; therefore, their findings may be useful to consumers. This information is not generally accessible to patients using the most popular Internet search engines. Inaccurate and incomplete information may cause harm by deflecting patients from optimal decisions.