Certain key parameters such as safety, efficacy, effectiveness, and cost effectiveness have long been established as key in HTA analysis. Equally important, however, are sociolegal and epidemiologic perspectives. A comprehensive analytic framework will consider the implications of using a technology in the context of societal norms, cultural values, and social institutions and relations. The methodology in which this expanded framework has been developed is termed ‘Strategic HTA’ to denote its power for the decision-making process. In addition to systematic reviews of published evidence, it incorporates analyses of the influence of dominant social relations on technological development and diffusion. This essay discusses the social epidemiologic aspects of health technology assessment, which includes factors such as sex and gender. It seeks to show how it is possible to bring data from wide-ranging disciplinary perspectives within the parameters of a single scientific inquiry; to draw from them scientifically defensible conclusions; and thereby to realize a deeper understanding of technology impact within a health care system. Armed with such an understanding, policy officials will be better prepared to resolve the competitive clamor of stakeholder voices, and to make the most “equitable” use of the available resources.

Objectives: The Scottish Health Technologies Group (SHTG) produces rapid reviews on nonmedicine technologies to inform advice for decision making in the National Health Service in Scotland (NHSScotland). This study describes our experiences and lessons learned in adapting for NHSScotland two rapid Relative Effectiveness Assessments (REAs) produced as part of the European Network for Health Technology Assessment (EUnetHTA) project to test collaborative preparation and then local adaptation.

Methods: The REAs were examined for their relevance to NHSScotland and the feasibility of their adaptation evaluated using a screening toolkit. Some supplementary literature searches were conducted and additional background information on epidemiology and the specific technologies was sought. To inform decision making within Scotland, it was also necessary to identify and review cost-effective analyses.

Results: Robust evidence reviews were delivered for NHSScotland. Time saved was less than anticipated, partly due to the need to add in health economic information, and partly because of attempts to supplement and update the EUnetHTA material. The preparation of an accompanying advice statement for NHSScotland enabled the inclusion of local contextual information.

Conclusions: Collaborative production and adaptation of HTAs is feasible and would be aided by the inclusion of cost-effectiveness analyses in the original work. Agencies should develop clear processes for adapting such reviews for their context with the focus on selecting appropriate topics for adaptation, avoiding unnecessary supplementation of the original work, and ensuring local ownership of final advice.

To reduce their dependency on donors or the international currency costs of essential health care products, developing countries are building or improving capability for local manufacturing or competitive international procurement. Through long-term strategic planning, public/private partnerships, collaboration with firms in industrialized nations, and farsighted donor policies, the capacity for alternative supply can be increased in stages from importation through local processing and packaging to full production and multiproduct enterprises.

Objectives: To promote the further development of HTA, this study aims to design a model for HTA priority setting, which would address national needs for a country with little experience in the field of HTA, and assess its feasibility for the health system.

Methods: Literature search and review, as well as qualitative research have been used in the design and testing of the model for HTA priority setting. To test the model and the methodology, a three-round Delphi study was conducted in 2011 in the form of an electronic questionnaire, which was distributed to the panel of eleven national experts. The panel was composed of experts representing various fields of the health care sector: policy-makers, health care service professionals and academics, with diverse professional roles.

Results: The designed model consists of four stages: (i) selection of experts for the panel, (ii) indication and selection of health policy topics, (iii) identification of health technologies, and (iv) priority setting. Three rounds of the Delphi study were performed to test the model and reach expert consensus on a list of health technologies for assessment, including pharmaceuticals, vaccines, medical devices, diagnostic methods, public health interventions, organizational systems, etc.

Conclusions: Based on the Delphi technique as a method for consensus building, the model for HTA priority setting was developed for Lithuania; however, it could also be used for other countries with little experience in the field of HTA.

The ability to extract information on resource use from randomized controlled trials can provide the groundwork for systematically compiling health economic reviews of health interventions. A review of the brief smoking interventions in general practice demonstrates that not all the necessary information can be extrapolated from these trials, and cost data will have to be supplemented from other sources.

This article is based on the report, Anticipating and Assessing Health Care Technology, written in the Netherlands between 1985–1988. The project was carried out because of increasing concern in the Dutch Ministry of Health (STG, then WVC) about the costs and benefits of new technologies for health care. At that time, there were no established models for early identification, so the project was not only the most extensive such effort to that date, but had to develop its own methods. Overseen by a special commission, the project staff identified many future and emerging technologies in health care and assessed selected technologies. Although the actual information produced was quickly dated and the project was discontinued in 1988, it did stimulate the Ministry of Health to ask the Dutch Health Council (Gezondheidsraad) to continuously identify important new technologies. The reports also demonstrated the potential usefulness of such an effort to Dutch policy makers, and probably to those in other countries as well.

Objectives: Medical technology is a large and expanding industry. Introducing new medical devices is important but several challenges exist in implementing the optimal method of evaluation. Both objective and subjective measures can be used for evaluation. The former is the mainstay of evaluation, yet subjective assessment is often the basis for the introduction of new medical technology. The aim of this study was to determine the interaction and concordance between objective and subjective assessment of new medical technology.

Methods: This study used both objective performance measures and subjective user perceptions in the evaluation of a new medical device designed to improve the accuracy of gravity-assisted delivery of intravenous fluids, compared with the current, widely used “roller-clamp” device. The concordance of objective and subjective assessments was evaluated using comparative analysis.

Results: Objective assessment of the accuracy of intravenous fluid delivery revealed no difference between the two devices (p = .636). Subjective assessment revealed that the new device was perceived to be significantly more accurate (p = .001). This lack of concordance can be partially explained by both device and demand characteristics.

Conclusions: This case study reveals a significant discordance between the objective and subjective assessments. It provides some explanation for why new medical devices are adopted without objective evidence of benefit. This phenomenon has been termed “persuasive design” and its influence should be controlled for in the evaluation, purchase and introduction of new medical devices. This should help reduce the risk and associated cost of premature introduction.

Objectives: In clinical trials of new cancer drugs, reliable data for progression-free survival will often become available far sooner than reliable data for overall survival. The aim of this study was to determine how many months it would be expected that any given new drug for metastatic breast or colorectal cancer will add to overall survival times given that the number of months the drug adds to progression-free survival times relative to a standard drug is roughly already known.

Methods: A literature search was conducted over Medline for randomized controlled trials (RCTs) published between January 1980 and August 2008 that assessed the effect of a drug treatment in comparison to an alternative drug treatment on patients with either metastatic breast or metastatic colorectal cancer.

Results: The literature search found 95 and 74 RCTs for metastatic breast and colorectal cancer, respectively, that satisfied the study's inclusion criteria. The results from these trials are consistent, in the case of each of these two metastatic cancers, with gains in time to disease progression being generally associated with no gains or with very slight gains or losses in post-progression survival (i.e., the time between disease progression and death).

Conclusions: It would appear that drugs for metastatic breast or colorectal cancer that extend, by a given amount, the time period between the start of treatment and disease progression (i.e., time to progression) have a strong tendency to extend, by roughly the same amount, the period between the start of treatment and death (i.e., overall survival).

Deapite the importance of understanding factors related to physician adoption and use of diagnostiv technologies, relatively few studies have been published. Results of a two-year study of the adoption of magnetiv resonance imaging (MRI) and its substitution for computed tomography scanning (CT) are presented. The literature on physician adoption and use of technologu is used to provide a frame-work for this study. Differences in adoption and substitution among medical specialties, early versus late adopters, and high versus low users of MRI are examined. Results show that neuerologists and internists more rapidly adopt MRI and substitute it for CT than do orthopedists and other surgical specialists. Referral of higher number of patients is the best predictor of more rapid substitution. Physicians who were late adopters more quickly substituted MRI for CT. The cost and social implications of empirical versus “ideal” substitution rates are discussed along with various regulatory, technology assessment, and finicial strategies influence substitution. The role of individual physicians, radiologists, and specialty societies in determining substitution rates is also discussed.

In order to explore the diffusion of the selected technologies in one Canadian province (British Columbia), two administrative data sets were analyzed. The data included over 40 million payment records for each fiscal year on medical services provided to British Columbia residents (2,968,769 in 1988) and information on physical facilities, services, and personnel from 138 hospitals in the province. Three specific time periods were examined in each data set, starting with 1979–80 and ending with the most current data available at the time. The detailed retrospective analysis of laboratory and imaging technologies provides historical data in three areas of interest: (a) patterns of diffusion and volume of utilization, (b) institutional profile, and (c) provider profile. The framework for the analysis focused, where possible, on the examination of determinants of diffusion that may be amenable to policy influence.

Large registries have been used by the National Heart, Lung, and Blood Institute to evaluate a number of medical procedures. Two of these, the Coronary Artery Surgery Study (CASS) and the Balloon Valvuloplasty Registry (BVR), are described to illustrate potential problems in using registry data to compare medical procedures.

This consensus statement was prepared by an independent panel of health professionals, academics, and public representatives based on (1) relevant published studies assembled by the Institute of Health Economics, (2) presentations by experts working in areas relevant to the conference questions, (3) presentations by people living with diabetes, (4) questions and comments from conference attendees during open discussion periods, and (5) closed deliberations by the panel. It is an independent report of the panel and is not a policy statement of the Institute of Health Economics or the Government of Alberta. This consensus statement reflects the panel's assessment of scientific knowledge available at the time the statement was written. The objectives of the panel are to develop a consensus statement on the benefits and costs of testing supplies for self-monitoring of blood glucose in diabetes, to inform patients, health policy, and practice.

Fifty-three deaf patients were screened psychologically and medically for suitability to receive an intracochlear implant. After initial screening for psychological normalcy, candidates were assessed again 1 year postimplant. Isolated deleterious psychological effects were found, and certain aspects of psychological functioning were enhanced. Overall evidence suggests that the implant is not psychologically damaging.

It has been repeated ad nauseam in recent years that health care is changing rapidly. Today even the pattern of change itself is in flux: modifications seem to be accelerating and shifts are of a more profound nature. Moreover, the prevailing changes are highly interactive and send ripples through a health care arena which presents all the symptoms of turmoil.

Objectives: The aim of this study was to explore and describe the viewpoints and beliefs with respect to a health technology assessment (HTA) process and its institutionalization in a sample of stakeholder representatives in Chile.

Methods: A qualitative study with a descriptive design, based on the model of discourse analysis, was performed. Eighteen semi-structured interviews were conducted on nineteen Chilean representatives of stakeholders in HTA. The data analysis was based on a process of open coding that allows the contrasting of the interviewees’ visions.

Results: From what the interviewees mentioned, a proposal to institutionalize the process of HTA is presented for Chile. The focus is on three main areas: (i) Principles to guide the HTA, (ii) Institutional Framework for Chile, and (iii) Impacts associated with their implementation process. Transparency and participation were the main principles identified. The idea of an autonomous body for HTA, independent and publicly funded, was widely supported. However, this implementation could face potential resistance from technicians and politicians, who might impose barriers to avoid their loss of decision power.

Conclusions: There is a broad agreement about the importance of creating a national institution for HTA, independent and publicly funded. This study supplies relevant information for other countries that are currently undertaking a similar process.

After 25 years of debate about privacy of automated personal health data, the U.S. Congress has set a deadline of August 1999 for enacting health information privacy legislation. The urgency to establish national policy in the United States re-emerges with implementation of a 1996 law mandating a unique identifier for each participant in the U.S. medical care system and the use of a uniform electronic data set for all health information transmitted in financial and administrative transactions. The impact of electronic data storage and transmittal on privacy, health outcomes, and medical care is unclear. A three-step analytic scheme can clarify the issues in the policy debate and for future assessment. The first step is intended to elicit, for the first time, a precise, accurate, and reproducible description of personal health data transactions and chains of transactions, independent of the policy preferences of any interested party. The second step allows the reader to analyze these transactions according to who benefits first and foremost from each. This scrutiny clarifies the reasons why parties to the debate tend to disagree. The third step characterizes how Congress is likely to perceive the policy process and consider its options before enacting any particular set of compromises. Understanding the policy deliberations and potential effects of evolving information technologies and new national privacy rules should aid assessment of results.

A common criticism of high technology is that therapeutic objectives are sometimes secured at too high a price in loss of quality of life. Certainly some interventions serve only to prolong life that is already of unacceptable quality to the patient (some rescues in intensive care and salvage surgery for cancer). Others leave the patient with less good quality of life than he enjoyed before treatment, either because the crisis that called for rescue had lasting effects (incomplete recovery from severe head injury) or because the intervention itself had inevitable adverse effects (mastectomy, laryngectomy, colostomy). Yet some life-extending technologies can improve dramatically the quality of a patient's life (renal and heart transplantation), while others are directed primarily at improving quality of life (hip replacement and coronary bypass surgery). When the ultimate result of technological intervention is improved quality of life or a reasonable extension of life of quality, then some temporary impairment of life's quality may be justifiable. The problem is to discover in which clinical circumstances the benefits expected from high technology are both great enough, and are also likely enough to be realized, to justify the resources that have to be expended by society and the inevitable burdens that have to be borne by the patient (11).