Objectives: A set of fifteen key principles (KP) has been recently proposed to guide decisions on the structure of HTA programs, the methods of HTA, the processes for conducting HTA and the use of HTA findings in decision-making. The objective of this research is to explore whether these KPs are relevant and useful in Latin America (LA), and to what extent they are being applied.

Methods: A Web-based survey was sent to 11,792 HTA researchers and users in LA to explore the perceived relevance of each KP, its current level of application and the gap between these two.

Results: We received 1,142 responses from nineteen LA countries (9.7 percent response rate). The subgroup of KP related to Methods and to the Use of HTA received the higher mean scores in the relevance scale (9.00 and 8.94). Level of current application scored low in all KP (3.2 to 4.9). Higher gaps were observed in principles related to the use of HTA in decision making and to the processes for conducting HTA. Countries with more developed HTA showed higher scores in the degree of current application (5.3 versus 3.4, p < .01) and lower gaps (3.84 versus 5.21, p < .01). Researchers, compared with research users, scored the relevance of the KPs higher.

Conclusions: KPs seem to be very relevant to most HTA researchers and users in LA. However, the current level of application was considered uniformly poor. Higher gaps were observed in KPs related to the link between HTA and decision making, highlighting one of the major challenges for the countries in the region.

Several new topical agents have been introduced recently and it can be expected that the treatment of glaucoma will change, depending on how effectively these agents control intraocular pressure (IOP). IOP is considered the major risk factor in the development of glaucomatous damage. In order to estimate the impact of these new agents on the cost of treating glaucoma, a simulation model was created to estimate the cost of treating patients with a recent diagnosis of primary open-angle glaucoma or ocular hypertension in different countries. The Markov model is based on retrospective chart reviews in different countries and calculates only cost, not outcome. Results are presented for France and the United Kingdom, where current treatment appeared to be comparable. Average one-year costs per patient with current treatment were FF2,389 (US $389) and £380 (US $627), respectively. Costs with the new treatments were lower than with current therapy.

Objectives: In recent years, there has been growth in the use of health technology assessment (HTA) for making decisions about the reimbursement, coverage, or guidance on the use of health technologies. Given this greater emphasis on the use of HTA, it is important to develop standards of good practice and to benchmark the various HTA organizations against these standards.

Methods: This study discusses the conceptual and methodological challenges associated with benchmarking HTA organizations and proposes a series of audit questions based on a previously published set of principles of good practice.

Results and Conclusions: It is concluded that a benchmarking exercise would be feasible and useful, although the question of who should do the benchmarking requires further discussion. Key issues for further research are the alternative methods for weighting the various principles and for generating an overall score, or summary statement of adherence to the principles. Any weighting system, if developed, would need to be explored in different jurisdictions to assess the extent to which the relative importance of the principles is perceived to vary. Finally, the development and precise wording of the audit questions requires further study, with a view to making the questions as unambiguous as possible, and the reproducibility of the assessments as high as possible.

This paper recounts the origins of consensus development as a means of technology assessment and traces the evolution of the process from its rather amorphous and variable beginnings to the codified and consistent model of today. Where appropriate, evaluative findings and anecdotal observations will be recounted.

Objectives: New medical technologies have been identified as the leading cause of increasing health-care expenditures. Adoption of a new technology is one of the most important decisions in medical centers. The objectives of this study were to map and describe the function of hospital decision-makers within the area of new technology assessment and adoption, and to examine relevant considerations, sources of information, and decision-making processes in the adoption of a new technology.

Methods: A questionnaire was mailed to hospital executives and referred to (i) the considerations for and against adoption of a new technology, (ii) the decision-making process, (iii) information sources used in the decision-making process.

Results: The most frequent criteria favoring adoption included increased cost-effectiveness, increased efficacy, and decrease in complication rates. An increase in complication rates or side effects and decreased efficacy were the top ranked criteria against adoption. The final decision-making responsibility varied among technologies; the medical director frequently made the final decision when a new device was involved, but this responsibility decreased when a new drug or a new procedure was considered. Participation in scientific meetings, opinions of local experts, medical journals, and Food and Drug Administration clearance documents were the most important information sources used in the decision-making process. However, these were not necessarily the optimal sources of information. Significant barriers in adoption decision-making are lack of timely data regarding the safety of the new technology, its cost-effectiveness, and efficacy.

Conclusion: To improve the adoption decisions, hospitals must develop criteria upon which the decision-making will be based.

Based on an American multicenter study, an economic evaluation of prophylactic misoprostol was undertaken in Sweden. The study included 420 patients with osteoarthritis and nonsteroidal anti-inflammatory drug (NSAID)-associated abdominal pain, but no gastric ulcer at inclusion. The frequency of ulcer development with and without prophylactic misoprostol was assessed at 21.7% and 5.6%, respectively, for a 3-month period. All costs for drugs, ambulatory care, hospital care, loss of production, as well as other factors such as dosage and compliance, were transferred to Swedish conditions. It was concluded that in patients with osteoarthritis and NSAID-induced abdominal pain, prophylaxis with misoprostol is cost-effective in Sweden, which is similar to what is found for other countries. A prerequisite for this result is a frequency of ulcer development of 15%. A patient compliance to prophylactic treatment of more than 60% is also presupposed (79% was observed in the above study). Due to the high age of the osteoarthritis patient population, the cost-effectiveness is influenced to only a minor extent by whether indirect costs are included in the calculation.

Objective: This paper presents the method we used in programming research on the efficacy of therapeutic interventions for nine chronic benign pain disorders.

Methods: We started with an inventory to identify commonly applied interventions. For these interventions we searched the literature to identify gaps in evidence. First, we searched for recent reviews, of which we assessed the methodologic quality. If only reviews of poor or moderate quality were found, a new systematic review was recommended. When we found no recent reviews, we searched for randomized controlled trials (RCTs). If there was insufficient or inconsistent evidence, the performance of a new RCT was advised. This structured procedure resulted in a list with topics for which new systematic reviews were recommended and topics for which new RCTs were needed. These lists were the starting points for priority setting by four Centers for Pain Management and Research. All members of the centers were asked to state the priority of each topic. The resulting hierarchy of topics for their own center was discussed in a meeting in each center, giving participants the opportunity to elucidate their views and considerations.

Results: The final result was a robust priority list for the need of research (systematic reviews and RCTs) on chronic benign pain syndromes.

Discussion: The strength and weaknesses of this approach are discussed. This method of priority setting is by no means restricted to treatments for chronic pain; it is also a useful approach for programming research to enable evidence-based medicine in other fields of interest.

Objectives: The aim of this study was to define an effective early warning system, to identify and rank the characteristics of an effective early warning system for emerging health technologies, and to evaluate current early warning systems against these characteristics.

Methods: An iterative Delphi-type process with the thirteen members of the International Information Network on New and Changing Health Technologies (EuroScan). We synthesized key characteristics that network members had graded. Members were then asked whether these characteristics were present or fulfilled in their system.

Results: The definition of an effective early warning system developed was the following: a system that identifies innovations in the field of health technology likely to have a significant impact; and disseminates information relevant to the needs of the customer which is timely, so as to enable appropriate decision making (such as resource allocation), facilitate appropriate adoption, and identify further research requirements. Five primary and eleven secondary components of effective early warning systems were identified. The five primary characteristics concerned relevance, independence, resourcing, a clear pathway for the outputs to reach decision makers, and defined customers. Although the primary characteristics were present or fulfilled to some extent in the majority of evaluated early warning systems, there was considerable variability in the presence of the secondary characteristics in the evaluated systems.

Conclusions: Our study provides a definition for an effective early warning system and a shared understanding of the important characteristics and components of such systems. This work should provide guidance to those setting up new early warning systems as well as for those managing and reviewing current systems.

Objectives: Industrial management principles could be used to improve the quality and efficiency of health care. In this study, we have evaluated the effects of a process management approach to trauma patient care. The major objective was to reduce the waiting times and increase the efficiency of the hospital.

Methods: Urgent surgery care was analyzed as an overall process. The process development followed the Plan-Do-Check-Act (PDCA) cycle and was based on statistical analysis of certain performance metrics. Data were collected from hospital databases and by personnel interviews. To develop the process, the anesthesia induction was performed outside the operating room, better process guidance was developed, and patient flow was reorganized. The transition time for these changes was 1 year (2002 to 2003).

Results: Waiting times decreased by 20.5 percent (p<.05), nonoperative times in the operating room were reduced by 23.1 percent (p<.001), and efficiency was increased by 9.7 percent (p<.001) after reengineering of the care process. Overtime hours decreased by 30.9 percent.

Conclusions: Managing urgent surgical care as a process can improve the productivity and quality of care without a need to increase personnel resources. The focus should be on reducing waiting times and waste times.

Background: There is a considerable gap between randomized clinical trials and implementing the results into practice. This is particularly relevant in the use of broad-spectrum antibiotics in hospitals. Hospital pharmacists can be effective vehicles for bridging this gap and promoting evidence-based medicine. To determine the most effective way of using the pharmacist in this role, a prospective cefotaxime intervention study was conducted with randomization incorporated into the design as well as patient-related therapeutic outcomes.

Methods: A total of 323 patients who were prescribed cefotaxime were randomized into an intervention or nonintervention group where only the former was challenged by pharmacists for inappropriate cefotaxime usage relative to hospital guidelines. The primary outcome was the appropriateness of cefotaxime prescribing between groups. Logistic regression analysis was then used to identify factors that were associated with successful clinical response.

Results: Overall, 94% of orders in the intervention group met cefotaxime dosage criteria compared with 86% in the control group (p = .018). However, there was no impact with respect to promoting cefotaxime use for an appropriate indication (81% vs. 80%; p = .67). There was a trend for improved clinical outcomes in patients who received cefotaxime within hospital guidelines (OR = 1.73; p = .31).

Conclusions: The pharmacist as a vehicle for promoting the appropriate use of broad-spectrum antibiotics in the acute care hospital setting can improve the dosing of such agents. However, several barriers to optimizing the impact of the pharmacist were implied by the data. Removing these barriers could increase the pharmacists' utility as an agent for improved patient care.

Objectives: This study is to review health technology assessment (HTA) development in China during the past two decades, and to facilitate further development of HTA and its integration into policy making.

Methods: The study depends very much on the extensive experiences of the authors in involvement of HTA in China. In addition, literature review and Web site searching have been used to trace the process of growth of HTA in China.

Results: With its rapid economic development, the Chinese health system has had many achievements in the past 30 years. However, there are some weaknesses that have developed during this period. HTA is traced back to the early 1990s in China. First, HTA knowledge transfer and establishment of HTA units were effective ways to develop HTA in China. By the end of 1990s, the policy makers of the Ministry of Health (MoH) made efforts to merge HTA with policy making to improve the quality and efficiency of health care. The main government authorities related to health technology are the State Food and Drug Administration, the Ministry of Labor and Social Security, and the MoH. Their involvements in HTA are varied.

Conclusion: A technology licensure mechanism based on HTA, including technology permission for use, institution licensure, and workforce licensure, is being gradually carried out by the MoH in China. Moreover, HTA can play an important role in technology market entry, insurance benefit coverage, formulary, clinical pathway, reimbursement, and so on. There is a great opportunity for HTA to be an important part of health reform, especially to help policy makers within the health sector to make difficult decisions.

Objective: To explore the impact of methodologic issues on the results of meta-analyses. The following issues were examined: the type of literature search strategy used; inclusion or exclusion of non–peer-reviewed studies; the inclusion or exclusion of non-English language publications; the effect of trial quality; and the inclusion or exclusion of non–placebo-controlled studies.

Methods: The International Study of Perioperative Transfusion (ISPOT) meta-analyses were used to evaluate each of the methodologic issues. The 10 meta-analyses consisted of technologies to reduce the need for perioperative red blood cell transfusion. The number of trials for each of the meta-analyses varied from 2 to 45. Both EMBASE and MEDLINE searches were conducted, including the use of systematic search strategies.

Results: MEDLINE identified the vast majority of trials. Alone, MEDLINE would have missed 8 studies compared to 10 for EMBASE. Use of the systematic search strategies greatly reduced the number of articles to be reviewed compared to open searches. Type of publication, country of study origin, inclusion of non-English publications, and trial quality had very little impact on the estimates of effect. The use of placebo versus open-label control affected the magnitude of the odds ratio for two of the meta-analyses. The results of the two meta-analyses were not statistically significant if only placebo-controlled trials were included.

Conclusions: While methodologic issues had very little impact on the ISPOT meta-analyses, further studies are needed in a variety of other clinical settings. Because MEDLINE, coupled with a review of the references in the identified trials, identified the vast majority of trials, one needs to consider the costs and benefits of searching EMBASE and the pursuance of unpublished and unindexed trials.

Objectives: The mode of contact and response levels of authors who had been asked to provide missing or incomplete data for a systematic review on diet and exercise interventions for weight loss was examined.

Methods: We contacted authors by electronic mail, letter, or both. Survival analyses were performed with the Kaplan–Meier method to determine differences in the proportion of responders over time among the different modes of contact and to determine whether response rates differed between authors from the United States and those from other countries. Logistic regression was used to determine whether the number of items requested and publication date influenced the likelihood of response.

Results: Two hundred forty-one (39.9 percent) studies had missing or incomplete data (e.g., sample size, age, caloric restriction, exercise amount, and so on). We were unable to locate ninety-five authors (39.4 percent). Of the remaining authors, forty-six authors (31.5 percent) responded to information requests. Time to respond differed by contact method (p<.05): e-mail (3 ± 3 days), letter (27 ± 30 days), and both (13 ±12 days). Response rates from U.S. authors did not differ from those of other countries.

Conclusions: Our study suggests poor success in the acquisition of essential information. Given considerable time and resources, weight loss studies require improved reporting standards to minimize the relatively unsuccessful attempt to contact authors for important and necessary information.

Objectives: The aim of this study was to estimate direct and indirect excess costs attributable to stroke in Sweden in 2009 and to compare these with similar estimates from 1997.

Methods: Data on first-ever stoke admissions in the first half of 2009 from the Swedish national stroke register (RS) were used for cost calculations and compared with results from 1997 also using RS data. A societal perspective was taken including the acute and follow-up phase, rehabilitation, stroke re-admissions, drugs, home- and residential care services for activities of daily life (ADL) support, and indirect costs for premature death and productivity losses (2009 prices). Survival was extrapolated to estimate the lifetime present value cost of stroke.

Results: The societal lifetime present value cost for stroke in 2009 was €68,800 per patient (ADL support: 59 percent; productivity losses: 21 percent). Women had higher costs than men in all age groups as a result from greater need for ADL support. Patients treated at a stroke unit indicated low incremental cost per life-year gained compared with those who had not. The total lifetime cost increased between 1997 and 2009. Hospitalization costs per patient were stable, while long-term costs for home- and residential care services increased.

Conclusions: Changes in patient characteristics, longer expected survival, and possibly in the Swedish stroke care, have led to higher annual and lifetime costs per patient in 2009 compared with 1997. A comprehensive national stroke care performance register like RS may be suitable for health economic assessments.

Objectives: Health technology assessment (HTA) programs influence practice on a broad scale through reimbursement decisions or national guidelines. Hospital-based HTA programs inform clinical decisions at the local level. Typically, they do this by adapting general HTA to their local setting, or by creating new HTA. However, unlike payer-based HTA organizations, hospital-based HTA organizations can also integrate local data into their reports.

Methods: We describe two examples of local data integrated into hospital-based HTA. In the first, qualitative data were used to select a new cardiac catheterization lab. In the second, quantitative data was used to inform a decision on whether to continue telemedicine services to critical care units. Local evidence sources included equipment service records, and interviews with physicians, technicians, and administrative staff in the first example, and the hospital's administrative and claims databases in the second example.

Results: In each case, there was little evidence from the peer-reviewed literature that could be applied to the decision. In the first example, staffing patterns and local preferences had considerable bearing on technology choices. In the second example, local outcomes data from administrative records were decisive.

Conclusions: Hospital-based HTA using local data can fill gaps in the published evidence, and also improve the generalizability of evidence to the local setting. To take advantage of local evidence, health systems should encourage the development of hospital-based HTA centers, seek out local preference data, and maintain databases of patient outcomes and utilization of services.

Objectives: In quality-adjusted life-years (QALY) models, it is customary to weigh life-years with quality of life via multiplication. As a consequence, for positive health states a longer duration has more QALYs than a shorter duration (i.e., longer is better). However, we have found that for poor health states, many prefer to live only a limited amount of time (i.e., longer is worse). Such preferences are said to be maximum endurable time (MET). In the present contribution, the following questions are asked: a) How low does the utility have to be in order for a MET to arise? and b) Do MET preferences occur when patients judge hypothetical health states?

Methods and Results: We reanalyzed data from 176 students for the hypothetical health states of “living with migraines” and “living with metastasized cancer.” For utilities smaller than 0.7 (ranging from 0 to 1), the MET preference rate was larger than 50%. High MET preference rates were also found in two new studies on migraine and esophageal cancer patients, who evaluated hypothetical health states related to their disease.

Conclusions: We discuss the interpretation of the MET preferences and the preference reversal phenomenon. Standard QALY models imply that longer is better. However, we find that more often, longer is worse for poorly evaluated health states. Consider the following question: are 3 years with a weight of 0.3 equally as valuable as 1 year with a weight of 0.9? Our results suggest that the 3-year period may be less valuable because for poor health, many will prefer a 1-year over a 3-year period.

This paper examines the determinants of hip fracture costs and further evaluates potential savings in costs when the occurrence of hip fracture is prevented. The costs of hip fracture are comprised of direct costs from health care and the social welfare system. Data were collected for 1,080 postmenopausal women admitted from private residence for primary hip fracture surgery during the year of 1992 in the city of Stockholm, Sweden. It was found that the cost of hip fracture is significantly related to age, mortality the year after a fracture, type of fracture, costs 1 year before a fracture, and hospital admission. The savings in direct costs for an average woman surviving the year after a fracture amount to SEK 210,000.

Objectives: This article explains how the issue of stakeholder involvement was addressed in the European network for Health Technology Assessment (EUnetHTA) Project and describes the structures of future stakeholder involvement in the EUnetHTA Collaboration.

Methods: Initiatives led to a dialogue with stakeholders and exchanging views and expectations on health technology assessment (HTA) processes and the future development of EUnetHTA. The methods of involving different stakeholder groups in EUnetHTA included general information to stakeholders about EUnetHTA, targeted information on a Web site, analysis of stakeholder opinions on HTA and EUnetHTA, and development of a draft stakeholder policy.

Results: First steps were taken to organize processes to consolidate the legitimacy of EUnetHTA and its products and encourage the representation of interests, thus contributing to promoting the utilization of HTA in national/regional policy making. A stakeholder Web site, analyses of stakeholder opinions on HTA and EUnetHTA in a discussion topic catalog, and a draft stakeholder policy resulted from the work.

Conclusions: Stakeholder involvement in EUnetHTA is necessary to ensure the legitimacy and prospects for utilization of EUnetHTA and its products. The described activities and results create the foundation for a continued dialogue with, and involvement of, stakeholders. The EUnetHTA stakeholder meeting can be considered as a successful experience of dialogue between EUnetHTA and stakeholders, which should be continued. Our experience shows the challenge of obtaining balanced stakeholder representation across the identified stakeholder groups. Continued attention should be given to achieving balanced stakeholder representation.

This article provides a critical analysis of the impact of health technology assessment (HTA) on priority setting in The Netherlands. It describes the limited steering powers of the Dutch government; its complex interactions with insurers, health-care providers, and patients; and the role of HTA in this context as an attempt to rationalize the debate about cost-effectiveness issues. HTA has been drawn upon for decision making on the health insurance package. Also, HTA findings have been linked to the national guideline development programs of the medical community. However, these impacts by no means have been straightforward. We argue that the political nature of the priority-setting debate asks for a broader approach to what constitutes HTA, and how it should be drawn upon in priority setting. Suggestions are made on how to do justice to the social dynamics of decision making and the behavior of stakeholders in health-care systems.

Objectives: Interferon beta-1b has recently become available for the treatment of secondary progressive multiple sclerosis (SPMS). This study aims at estimating the cost-effectiveness of this new treatment that has been shown in a clinical trial to reduce the progression of the disease. Effectiveness is measured as the number of quality-adjusted life-years (QALYs) gained from the reduction in progression. Because the clinical trial period will only capture part of the treatment's effect in terms of QALYs gained, since benefits achieved during the trial will have an effect beyond it, the cost-effectiveness analysis involves modeling over the longer term using complementary data.

Methods: A Markov model with states based on disability expressed by EDSS scores was used. Transition probabilities were calculated directly from clinical trial data for the first 3 years and then extrapolated to 10 years. Mean costs and utilities for each Markov state were calculated from a population-based cross-sectional study in Sweden.

Results: The incremental cost per QALY is SEK 342,700 (US $39,250;US $1 = SEK 8.73, March 10, 2000) when all costs (direct, informal care, and indirect) are included (discounted 3%). When indirect costs are excluded, the cost per QALY is SEK 542,000 ($62,100).

Conclusions: Cost-effectiveness analysis in SPMS requires that the effect of treatment beyond clinical trials be included. Also, analysis should be done from a societal perspective, since many of the costs occur outside the healthcare system. The cost-utility ratios estimated in this analysis are at or below the mean threshold value indicated in a recent survey of health economists ($60,000).