Objectives: Registers have proven to be a valuable instrument in the evaluation of arthroplasty procedures and the performance of implants. The aim of this study was to describe the structure, functioning, and content of arthroplasty registers in Europe and other parts of the world.

Methods: A search of technical reports was carried out through the Internet and in Medline/PubMed. The exhaustiveness of the information was confirmed using the links to Web pages of other registers and contacts with key people. Aims, methods in data collection and evaluation, internal structure and organization, participants, validity of the data, and other variables were assessed for each arthroplasty register using a qualitative content analysis of the texts.

Results: Fifteen arthroplasty registers were identified which published sufficient information to conduct a comparative analysis. Eight additional registers were identified but no information was available on the Internet or in English. Most registers were initiatives of an orthopaedic society receiving governmental funding. Data were collected using standardized clinical forms and additional information from clinical-administrative datasets or other registers (mortality, implant costs, hip fractures). The main outcome measure of these registers is survival of the prostheses. Registers use the Internet and their annual reports as the main strategy for the dissemination and feed-back of their results.

Conclusions: Scientific or professional societies and the public health administration should collaborate in the development of arthroplasty registers. To adequately assess the results of observational data information on the structure, the process of arthroplasty interventions and patients characteristics should be collected.

Objectives: Obsolescence is a natural phase of the lifecycle of health technologies. Given increasing cost of health expenditures worldwide, health organizations have little choice but to engage in health technology reassessment (HTR); a structured, evidence-based assessment of the medical, social, ethical, and economic effects of a technology, currently used within the healthcare system, to inform optimal use of that technology in comparison to its alternatives. This research was completed to identify and summarize international HTR initiatives for non-drug technologies.

Methods: A systematic review was performed using the terms disinvestment, obsolescence, obsolete technology, ineffective, reassessment, reinvestment, reallocation, program budgeting, and marginal analysis to search PubMED, MEDLINE, EMBASE, and CINAHL until November 2011. Websites of organizations listed as members of INAHTA and HTAi were hand-searched for gray literature. Documents were excluded if they were unavailable in English, if the title/abstract was irrelevant to HTR, and/or if the document made no mention of current practices. All citations were screened in duplicate with disagreements resolved by consensus.

Results: Sixty full-text documents were reviewed and forty were included. One model for reassessment was identified; however, it has never been put into practice. Eight countries have some evidence of past or current work related to reassessment; seven have shown evidence of continued work in HTR. There is negligible focus on monitoring and implementation.

Conclusions: HTR is in its infancy. Although health technology reassessments are being conducted, there is no standardized approach. Future work should focus on developing and piloting a comprehensive methodology for completing HTR.

The development and diffusion of health-related technologies constitute an extremely complex process. This article examines the phenomenon of technological innovation; discusses the factors determining the diffusion of high, medium, and low technologies; and suggests strategies for controlling the diffusion of these technologies. A research program is also proposed that should improve our understanding of the process of development and diffusion of health-related technologies.

Objectives: This study aims to describe a cycle of development leading to sustainable methods for involving consumers in the management of a program commissioning health technology assessment.

Methods: Staff time was dedicated to developing procedures for recruiting and briefing consumers to participate in prioritizing, commissioning, and reporting research. Resources and support were developed in light of early feedback from consumers and those working with them. These were piloted and amended before being used routinely.

Results: Over 4 years, procedures and resources have been developed to support six consumers attending seven to eight prioritization meetings a year; thirty to forty-five consumers each year commenting on research need for particular topics; thirty consumers a year commenting on research proposals, and twenty a year commenting on research reports. The procedures include clear job descriptions, induction and development days, clear briefing materials, payment for substantial tasks, and regularly seeking feedback to improve procedures.

Conclusions: Explicit, inclusive, and reproducible methods for supporting consumer involvement that satisfy National Health Service policy recommendations for involving consumers in research require dedicated staff time to support a cycle of organizational development.

Objectives: Health technology assessment (HTA) is a policy-oriented form of research designed to inform decision-makers on the introduction, use, and dissemination of health technology. Whereas research on knowledge transfer has focused on knowledge producers, little attention has been given to the user's perspective. This study examines how health-care provider, administrator, and patient associations across Canada use HTA reports and the limitations they encounter when accessing and using scientific knowledge.

Methods: This study draws from semistructured interviews (n = 42) conducted with three types of user, located in British Columbia, Alberta, Saskatchewan, Ontario, and Quebec. Applying well-established conceptual categories in knowledge utilization research, our qualitative analyses sought to define more precisely how HTA is used by interviewees as well as the most significant barriers they encounter.

Results: The vast majority of users recognize the usefulness and credibility of HTA reports. Of interest, the way they use HTA takes different forms. Although administrators and health-care providers are in a better position than patient associations to act directly on HTA messages—making an instrumental use of HTA—we also found conceptual and symbolic uses across all groups. Our results also indicate that significant organizational, scientific, and material limitations hinder the use of scientific evidence. Overcoming such barriers requires a greater commitment from both HTA producers and users.

Conclusions: This study argues that, to ensure better uptake of HTA, it should become a shared responsibility between HTA producers and various types of user.

Does increased spending improve health outcomes? We analyzed 1988 data from OECD countries to determine how key health care indexes correlate with health care outcomes. Total health care spending per capita and outpatient and inpatient utilization are not related to health outcomes. How our resources are allocated seems to be more important than how much money is actually spent.

Objectives: The objectives of this study were (i) to develop a systematic framework for describing and comparing different features of health technology assessment (HTA) agencies, (ii) to identify and describe similarities and differences between the agencies, and (iii) to draw conclusions both for producers and users of HTA in research, policy, and practice.

Methods: We performed a systematic literature search, added information from HTA agencies, and developed a conceptual framework comprising eight main domains: organization, scope, processes, methods, dissemination, decision, implementation, and impact. We grouped relevant items of these domains in an evidence table and chose five HTA agencies to test our framework: DAHTA@DIMDI, HAS, IQWiG, NICE, and SBU. Item and domain similarity was assessed using the percentage of identical characteristics in pairwise comparisons across agencies. Results were interpreted across agencies by demonstrating similarities and differences.

Results: Based on 306 included documents, we identified 90 characteristics of eight main domains appropriate for our framework. After applying the framework to the five agencies, we were able to show 40 percent similarities in “dissemination,” 38 percent in “scope,” 35 percent in “organization,” 29 percent in “methods,” 26 percent in “processes,” 23 percent in “impact,” 19 percent in “decision,” and 17 percent in “implementation.”

Conclusion: We found considerably more differences than similarities of HTA features across agencies and countries. Our framework and comparison provides insights and clarification into the need for harmonization. Our findings could serve as descriptive database facilitating communication between producers and users.

Direct costs were estimated for the treatment, rehabilitation, and nursing of 125 patients with first stroke in the Lund and Orup health districts (population of 200,191). Patients were followed from the onset of stroke in 1983 until October 31, 1985. The data were used to calculate the present value of the expected lifetime direct costs for an individual contracting his or her first stroke at various ages. For example, at the age of 72, these costs were estimated at SEK 283,000 for a man and SEK 561,000 for a woman. Hospital care was the major cost component (75% for males and 89% for females) at this age of onset. The results could be used to estimate the economic benefits of preventing new strokes, hence, forming part of a cost-effectiveness or cost-utility analysis. Together with prognoses of the expected developments in the incidence of stroke, they could also serve as the basis of forecasts of future costs of the health care and social service sectors.

Objectives: This report is a scoping review of the literature with the objective of identifying definitions, conceptual models and frameworks, as well as the methods and range of perspectives, for determining appropriateness in the context of healthcare delivery.

Methods: To lay groundwork for future, intervention-specific research on appropriateness, this work was carried out as a scoping review of published literature since 1966. Two reviewers, with two screens using inclusion/exclusion criteria based on the objective, focused the research and articles chosen for review.

Results: The first screen examined 2,829 abstracts/titles, with the second screen examining 124 full articles, leaving 37 articles deemed highly relevant for data extraction and interpretation. Appropriateness is defined largely in terms of net clinical benefit to the average patient and varies by service and setting. The most widely used method to assess appropriateness of healthcare services is the RAND/UCLA Model. There are many related concepts such as medical necessity and small-areas variation.

Conclusions: A broader approach to determining appropriateness for healthcare interventions is possible and would involve clinical, patient and societal perspectives.

Objectives: Time costs borne by women when undergoing cervical cancer screening have rarely been elucidated, although such costs may pose substantial barriers to care. The purpose of this project was to quantify the opportunity costs associated with cervical cancer screening in young women attending Planned Parenthood Clinics.

Methods: We conducted a self-report survey of 105 women from six clinics to measure travel, waiting, and exam times associated with cervical cancer screening. Respondents recorded their time of arrival and departure, length of time in the waiting room, age, income level, and hours per week they worked outside of the home. Time costs were valued three ways: through self-reported hourly wage, age- and gender-adjusted minimum earnings, and national age- and gender-adjusted hourly wages.

Results: Respondents were on average 24 years old, worked 29 hours per week outside the home, and earned less than $20,000 per year. Mean time for one-way travel was 18.7 minutes; waiting room time was 16.9 minutes; and exam time was 50.8 minutes. Time costs were estimated to be $14.08 per visit based upon the self-reported hourly wage; $16.46 per visit based upon age- and gender-adjusted minimum earnings; and $19.63 per visit based upon age- and gender-adjusted national wage rates.

Conclusions: Time costs associated with cervical cancer screening represent an important opportunity cost and should be considered in studies attempting to identify barriers to screening adherence. Our results indicate that time costs accounted for up to 25% of cervical cancer screening costs. Time costs should be identified, measured, valued, and included in cost-effectiveness analyses of cervical cancer screening.

Health technology assessment (HTA) involves values and judgments, but there have been few attempts to seek the views of members of the public or to ensure that they have access to the results. Patients and citizens can make an important contribution to HTA by determining priorities for assessment, designing and conducting assessments and appraisals, receiving and using the findings, and engaging in debates about policy priorities and rationing. Those responsible for HTA should make greater efforts to involve the public and ensure that the findings are accessible to patients for use when making treatment choices.

Objectives: The cost-effectiveness of the Swedish quitline, a nation-wide, free of charge service, is assessed.

Methods: The study was based on data of a sample of 1,131 callers enrolled from February 1, 2000 to November 30, 2001. Outcome was measured as cost per quitter and cost per year of life saved. Cost per quitter was based on a calculation of the total cost of the quitline divided by the number of individuals who reported abstinence after 12 months. The cost per life year saved (LYS) was calculated by the use of data from the literature on average life expectancy for smokers versus quitters, the total cost of the quitline, and the cost of pharmacological treatment.

Results: The number of smokers who used the quitline and reported abstinence after 1 year was 354 (31 percent). The accumulated number of life years saved in the study population was 2,400. The cost per quitter was 1,052–1,360 USD, and the cost per life year saved was 311–401 USD. A sensitivity analysis showed that, for outcomes down to an abstinence rate of 20 percent, the cost per LYS rose modestly, from 311 to 482 USD. Discounting the cost per LYS showed the cost to be 135 USD for 3 percent and 283 USD for 5 percent.

Conclusions: The Swedish quitline is a cost-effective public health intervention compared with other smoking cessation interventions.

Individual programs for prevention of cardiovascular disease include dietary and drug treatment of hypercholesterolemia, hypertension treatment, and smoking cessation therapies. In this study, the cost-effectiveness of available cardiovascular prevention programs was assessed in Spain in terms of net cost per life-year gained (LYG). Cost-effectiveness ratios ranged from US $2,600 to $80,000 per LYG in men and from $4,500 to $230,000 per LYG in women. In men aged 40–59 years, the ranking of increasing cost-effectiveness was: smoking cessation ($2,608–3,738 per LYG); treatment of moderate and severe hypertension ($8,564–38,678 per LYG); treatment of mild hypertension ($11,906–59,840 per LYG); dietary treatment ($16,143–20,158 per LYG); and drug treatment of hypercholesterolemia ($33,850–81,010 per LYG). In women, the ranking list was: smoking cessation ($4,482–5,756 per LYG), treatment of moderate and severe hypertension ($9,585–57,983 per LYG), treatment of mild hypertension ($15,248–86,075 per LYG), dietary treatment ($57,175–62,154 per LYG); and drug treatment of hypercholesterolemia ($104,100–259,150 per LYG).

Objectives: A linked evidence approach (LEA) is the synthesis of systematically acquired evidence on the accuracy of a medical test, its impact on clinical decision making and the effectiveness of consequent treatment options. We aimed to assess the practical utility of this methodology and to develop a decision framework to guide its use.

Methods: As Australia has lengthy experience with LEA, we reviewed health technology assessment (HTA) reports informing reimbursement decisions by the Medical Services Advisory Committee (August 2005 to March 2012). Eligibility was determined according to predetermined criteria and data were extracted on test characteristics, evaluation methodologies, and reported difficulties. Fifty percent of the evidence-base was independently analyzed by a second reviewer.

Results: Evaluations of medical tests for diagnostic (62 percent), staging (27 percent), and screening (6 percent) purposes were available for eighty-nine different clinical indications. Ninety-six percent of the evaluations used either the full LEA methodology or an abridged version (where evidence is linked through to management changes but not patient outcomes). Sixty-one percent had the full evidence linkage. Twenty-five percent of test evaluations were considered problematic; all involving LEA (n = 22). Problems included: determining test accuracy with an imperfect reference standard (41 percent); assessing likely treatment effectiveness in test positive patients when the new test is more accurate than the comparator (18 percent); and determining probable health benefits in those symptomatic patients ruled out using the test (13 percent). A decision framework was formulated to address these problems.

Conclusions: LEA is useful for evaluating medical tests but a stepped approach should be followed to determine what evidence is required for the synthesis.

Background: The current study aimed to determine the accuracy of UHear™, a downloadable audiometer on to an iPod Touch©, when compared with conventional audiometry.

Methods: Participants were enrolled primary school scholars. A total number of eighty-six participants (172 ears) were included. Of these eighty-six participants, forty-four were female and forty-two were male; with the age ranging from 8 years to 10 years (mean age, 9.0 years). Each participant underwent two audiological screening evaluations; one by means of conventional audiometry and the other by means of UHear™. Otoscopy and tympanometry was performed on each participant to determine status of their outer and middle ear before each participant undergoing pure tone air conduction screening by means of conventional audiometer and UHear™. The lowest audible hearing thresholds from each participant were obtained at conventional frequencies.

Results: Using the Paired t-test, it was determined that there was a significant statistical difference between hearing screening thresholds obtained from conventional audiometry and UHear™. The screening thresholds obtained from UHear™ were significantly elevated (worse) in comparison to conventional audiometry. The difference in thresholds may be attributed to differences in transducers used, ambient noise levels and lack of calibration of UHear™.

Conclusion: The UHear™ is not as accurate as conventional audiometry in determining hearing thresholds during screening of school-aged children. Caution needs to be exercised when using such measures and research evidence needs to be established before they can be endorsed and used with the general public.

Objectives: The aim of this study was to describe a comprehensive continuum that has developed in Ontario between government and key stakeholder groups, including hospitals, physicians, academic institutions, clinical epidemiologists, health economists, industry, and bioethicists to achieve evidence-based recommendations for policy development.

Methods: The various components of the comprehensive model that has evolved to develop an evidentiary platform for policy development are summarized, and the flow between these components is described.

Results: The development of the Ontario Health Technology Advisory Committee (OHTAC) and associated programs demonstrate the need to go beyond the traditional steps taken within most health technology assessment paradigms. These components include pragmatic postmarketing studies, human factors, and safety analyses, and formalized interactions with a broad spectrum of potential end-users of each technology, experts, and industry. These components, taken together with an expanded systematic review to include a range of economic analyses, and societal impacts augment the traditional systematic review processes. This approach has been found to be important in assisting decision making and has resulted in an 81 percent conversion from evidence to policy consideration for eighty-three technologies that had been assessed at the time this article was submitted.

Conclusions: The comprehensive model, centered around OHTAC, has added important new dimensions to health policy by improving its relevance to decision makers and providing an accountable and transparent basis for government to invest appropriately in health technologies. This study could also form a basis for further research into appropriate methodologies and outcome measurements as they relate to each component of this approach.

Background: The relationship between regulatory approval on the one hand and health technology assessment (HTA) and coverage on the other is receiving growing attention. Those responsible for regulatory approval, HTA, and coverage have different missions and their information requirements reflect these. There is nonetheless an increasingly popular view that improved communication and coordination between these functions could allow them all to be undertaken effectively with a lower overall burden of evidence requirements, thus speeding patient access to new products and reducing unnecessary barriers to innovation. This study summarizes the main points emerging from a recent discussion of this topic at the HTAi Policy Forum.

Results and Conclusions: After considering the roles of the various bodies, stakeholder perspectives and some current practical initiatives, those present at the Forum meeting discussed possible goals and challenges for improved interactions—in general and at specific stages of the product development life cycle. Opportunities for progress were seen in: continuing the dialogue to promote understanding and interaction between the different bodies and stakeholders; working to align scientific advice for manufacturers on the design and data requirements of pre- and post-marketing evaluation of products (specifically phase 2/3 and phase 4 trials for drugs); and extending the current dialogue to include discussion of product development to address unmet health needs.

Health technology assessment (HTA) is primarily concerned with the consequences (benefits and costs) of health care and health policy decisions. Because decision making is complex and outcomes are often uncertain, it is helpful to attempt to assess the consequences. The quality of decisions can be improved by a process that provides a consistent framework for identifying and assessing health technologies.