Introduction: Many governments have introduced health technology assessment (HTA) as an important tool to manage the uptake and use of health-related technologies efficiently. Although surgeons play a central role in the uptake and diffusion of new technologies, little is known about their opinion and understanding of the HTA role and process.

Methods: A cross-sectional pilot study was conducted using an online questionnaire which was distributed to Fellows of the Royal Australasian College of Surgeons over a 4-week period. Information was sought about knowledge and views of the HTA process. Descriptive statistics were used to summarize the data, frequencies, and proportions were calculated.

Results: Sixty-two surgeons completed the survey; of these, 55 percent reported their primary work place as a public hospital. Twenty-four percent of the participants reported that they had never heard of the HTA agency and 60 percent reported that surgical procedures are most likely to be introduced in the Australian healthcare system at the public hospital level (which is beyond the HTA's scope and dealt with at a state level). However, 61 percent considered that decisions about funding and adoption of new technologies should take place at the national level.

Conclusions: This survey provides some evidence that many surgeons remain unaware of the federal government's HTA process but still value evidence-based information. In order for HTA to be an effective aid to rational adoption of health-related technologies, there is a need for an evidence-based approach that is integrated and is accepted and understood by the medical professions.

Objectives: The aim of this study was to examine the potential cost-effectiveness of self-managed computer therapy for people with long-standing aphasia post stroke and to estimate the value of further research.

Methods: The incremental cost-effectiveness ratio of computer therapy in addition to usual stimulation compared with usual stimulation alone was considered in people with long-standing aphasia using data from the CACTUS trial. A model-based approach was taken. Where possible the input parameters required for the model were obtained from the CACTUS trial data, a United Kingdom-based pilot randomized controlled trial that recruited thirty-four people with aphasia and randomized them to computer treatment or usual care. Cost-effectiveness was described using an incremental cost-effectiveness ratio (ICER) together with cost-effectiveness acceptability curves. A value of information analysis was undertaken to inform future research priorities.

Results: The intervention had an ICER of £3,058 compared with usual care. The likelihood of the intervention being cost-effective was 75.8 percent at a cost-effectiveness threshold of £20,000 per QALY gained. The expected value of perfect information was £37 million.

Conclusions: Our results suggest that computer therapy for people with long-standing aphasia is likely to represent a cost-effective use of resources. However, our analysis is exploratory given the small size of the trial it is based upon and therefore our results are uncertain. Further research would be of high value, particularly with respect to the quality of life gain achieved by people who respond well to therapy.

Objectives: The aim of this study was to develop an health technology assessment (HTA) decision tool to support the decision-making process on health technologies for hospital decision makers in cross-border regions.

Methods: Several methods were used to collect information necessary to develop the cross-border mini-HTA decision tool. The literature was inventoried on HTA in border regions and local settings and the use of HTA by local decision makers. Semi-structured interviews with hospital decision makers in cross-border regions were also performed. Based on group discussion of the resulting information, it was decided to use the Danish mini-HTA guideline as a starting point for development of the decision tool. After finishing the first version of the decision tool it was tested in two pilot studies

Results: Some questions in the Danish mini-HTA guideline were not relevant. Other questions needed rephrasing and questions about cross-border situations were added. The pilots showed several missing topics, including legal questions and reimbursement issues. The final decision tool consists of three sections: a general section, a section for hospitals not cooperating cross-border and a section for hospitals that are cooperating with hospitals across a national or regional border.

Conclusions: Based on our literature search, this may be the first cross-border mini-HTA decision tool. The decision tool will be of help for healthcare professionals and decision makers in border settings who would like to use HTA evidence to support their decision-making process.

Objectives: Several models of hospital-based health technology assessment (HTA) have been developed worldwide, for the introduction of innovative medical devices and support evidence-based decision making in hospitals. Two such models, the HTA unit and mini-HTA models, are widespread in university hospitals and involve various stakeholders. The purpose of this work was to highlight the potential role of hospital pharmacists in hospital-based HTA activities.

Methods: We searched for articles, reviews, and letters relating to hospital-based HTA, as defined by the Hospital-Based Health Technology Assessment Worldwide Surveypublished by the Health Technology Assessment International (HTAi) Society, in the Health Technology Assessment database, MEDLINE, EMBASE, and hospital pharmacyjournals.

Results: The number of university hospitals performing hospital-based HTA has increased since the 2008 Hospital-Based Health Technology Assessment Worldwide Survey. Our own experience and international findings show that hospital pharmacists already contribute to hospital-based HTA activities and have developed study interpretation skills and a knowledge of medical devices.

Conclusions: Promoting multidisciplinary approaches is one of the key success factors in hospital-based HTA. Hospital pharmacists occupy a position between hospital managers, clinicians, health economists, biomedical engineers, and patients and can provide a new perspective. In the future, hospital pharmacists are likely to become increasingly involved in hospital-based HTA activities.

Introduction: Spontaneous adverse drug events (ADE) reporting is the main source of data for assessing the risk/benefit of drugs available in the pharmaceutical market. However, its major limitation is underreporting, which hinders and delays the signal detection by Pharmacovigilance (PhV).

Objectives: To identify the techniques of educational intervention (EI) for promotion of PhV by health professionals and to assess their impact.

Methods: A systematic review was performed in the PUBMED, PAHO, LILACS and EMBASE databases, from November/2011 to January/2012, updated in March/2013. The strategy search included the use of health descriptors and a manual search in the references cited by selected papers.

Results: 101 articles were identified, of which 16 met the inclusion criteria. Most of these studies (10) were conducted in European hospitals and physicians were the health professionals subjected to most EI (12), these studies lasted from one month to two years. EI with multifaceted techniques raised the absolute number, the rate of reporting related to adverse drug reactions (ADR), technical defects of health technologies, and also promoted an improvement in the quality of reports, since there was increased reporting of ADR classified as serious, unexpected, related to new drugs and with high degree of causality.

Conclusion: Multifaceted educational interventions for multidisciplinary health teams working at all healthcare levels, with sufficient duration to reach all professionals who act in the institution, including issues related to medication errors and therapeutic ineffectiveness, must be validated, with the aim of standardizing the Good Practice of PhV and improve drug safety indicators.

Objectives: This study presents findings from a study that explores the merits of different methods for assessing the international use of UK funded research by the National Institute of Health Research Health Technology Assessment (NIHR HTA) Programme.

Methods: The study adopted an exploratory approach and used three core methods: (i) Academic use was explored through bibliometric and citation analysis of the top ten most cited health technology assessment (HTA) reports. (ii) Internet use was assessed using Webtrends software to identify the proportion of international visits of the top ten most downloaded HTA reports from January 1, 2004 to June 30, 2010. (iii) International HTA use was assessed by searching the Center for Reviews and Dissemination (CRD) HTA database to explore the citation of NIHR HTA reports in reports by non-UK HTA agencies.

Results: Bibliometric analysis identified published output and international citations with 41 percent of the 549 journals citing NIHR HTA reports being based in the United States. Nine of ten most downloaded reports from the NIHR HTA Web site (www.hta.ac.uk) had in excess of 50 percent of visits outside the United Kingdom. Four of five selected NIHR HTA reports were cited in twenty-eight other HTA reports, eighteen of these outside the United Kingdom.

Conclusions: Assessing international use is important when exploring the uptake of research evidence. Methods used in identifying research impact, such as bibliometrics and Webtrends, are helpful in generating evidence of international use. HTA agencies should consider these techniques and international use when assessing the uptake of findings from research they undertake and/or commission.

Objectives: To obtain further information from members of the International Network of Agencies for Health Technology Assessment (INAHTA) on the involvement of consumers in their programs.

Methods: A questionnaire for a survey was developed and sent to member agencies in November 2010. Survey responses were compared with those from an earlier survey conducted in 2005.

Results: Of the thirty-three agencies that provided responses, 67 percent involve consumers in some aspects of their health technology assessment (HTA) programs, compared with 57 percent in 2005. As in the earlier survey, most agencies reporting involvement have contact with consumer or patient organizations and a large minority also involve individual consumers. Summaries of HTA reports that are intended to be easily understood by consumers are prepared by 84 percent of the agencies, and 42 percent involve consumers in dissemination of HTA material. In both areas, there was some increase from the levels previously reported.

Conclusions: The survey results suggest that there is a trend to increased involvement of consumers by the INAHTA agencies in their programs but that the level of involvement remains relatively limited. The manner of consumer participation varies between agencies.

Objectives: No guidelines exist in the approach that Evidence Review Groups (ERGs) should take to appraise search methodologies in the manufacturer's submission (MS) in Single Technology Appraisals (STA). As a result, ERGs are left to appraise searches using their own approach. This study investigates the limitations of manufacturers' search methodologies as critiqued by ERGs in published STA reports and to provide a recommended checklist.

Methods: Limitations from search critiques in 83 ERG reports published in the NIHR Web site between 2006 and May 2011 were extracted. The limitations were grouped into themes. Comparisons were made between limitations reported in the clinical effectiveness versus cost-effectiveness searches.

Results: Twelve themes were identified, six relating to the search strategy, source, limits, filters, translation, reporting, and missing studies. The search strategy theme contained the most limitations. Missing studies were frequently found by the ERG group in the clinical effectiveness searches. The omission of searches by manufacturers for unpublished and ongoing trials was frequently reported by the ERG. By contrast, failure of the manufacturer to report strategies was the most common limitation in the cost-effectiveness searches. Themes with the most frequent limitations in both types of searches are search strategy, reporting and source.

Conclusions: It is recommended that a checklist that has reporting, source and search strategy elements be used in the appraisal of manufacturer's searches during the STA process.

Objectives: In Austria, research in health technology assessment (HTA) has been conducted since the 1990s. The aim of this study is to analyze whether the HTA research program of the Institute of Technology Assessment (ITA) and the Ludwig Boltzmann Institute for HTA (LBI-HTA) have had an impact on the Austrian healthcare system.

Methods: We applied qualitative and quantitative empirical research methods, such as interviewing, download analysis, questionnaire, retrospective routine data analysis, and media analysis. Data were analyzed according to a conceptual framework, considering seven impact categories (awareness, acceptance, process, decision, practice, final outcomes, enlightenment) and different target groups.

Results: A rising number of downloads and single HTA reports with high media interest were identified. Interviews showed that HTA reports have increasingly been used for investment and reimbursement decisions, as well as for the preparation of negotiations. Economic impact was indicated by decreased expenditures due to HTA recommendations. Overall, knowledge about evidence-based medicine increased and, in places, an “HTA culture” can be recognized. Yet, several decision-making processes occur at all levels without the use of HTA.

Conclusions: The analysis demonstrated an impact within all predefined categories; however, it depends on the system level and its target groups. HTA reports are primarily used by hospital management, (social) insurances, and the Austrian Ministry of Health. Nevertheless, there is still potential to increase the impact of HTA. Therefore, the inclusion of HTA in decision-making processes in Austria needs to move from a voluntary basis to a mandatory one.

Background: Health technology reassessment (HTR) is “a structured, evidence-based assessment of the clinical, social, ethical, and economic effects of a technology currently used in the healthcare system, to inform optimal use of that technology in comparison to its alternatives.” The purpose of this study is to describe the key themes in the context of current HTR activities and propose a way forward for this newly emerging field.

Methods: Data were gathered from a workshop held as part of the 2012 Canadian Agency for Drugs and Technology in Health (CADTH) symposium. The workshop consisted of two panel presentations followed by discussion; data gathered, including presentations and rich audience discussion transcripts, were analyzed for key themes emerging in the field of HTR using constant comparative analysis.

Results: The language chosen to describe HTR will set the tone for engagement. The identification of champions at multiple levels and political will are essential. Key lessons from international experience are: disinvestment is difficult, focus on clinical areas not specific technologies, identify clear goals of the HTR agenda. Six key themes were identified to move the HTR agenda forward: emphasize integration over segregation, focus on development of HTR methods and processes, processes are context-specific but lessons must be shared, build capacity in synergistic interdisciplinary fields, develop meaningful stakeholder engagement, strengthen postimplementation monitoring and evaluation.

Conclusions: To move this field forward, we must continue to build on international experiences with a focus on developing novel methodological approaches to generating, incorporating, and implementing evidence into policy and practice.

Introduction: The translation of best evidence into practice has become an important purpose of policy making in health care. In Brazil, a country of continental dimensions with widespread regional and social inequalities, the dissemination and use of the best-evidence in policy making is a critical issue for the healthcare system.

Objectives: The main purpose of this study is to describe an evidence-based public health policy with special emphasis on guidelines creation for high-cost medicines. We also describe how that strategy was diffused to the judiciary system and to other parts of the healthcare system.

Results: We present an 11-year follow-up of a national project for creating and updating guidelines for high-cost medicines in Brazil. A total of 109 national guidelines were published (new or updated versions) for 66 selected diseases, the first such effort in Brazilian history. The project influenced the Brazilian legislature, which has recently established a Federal Law requiring national guidelines for any new technology listed for payment by the Brazilian public healthcare system.

Conclusion: We were able to involve many different stakeholders in a partnership between academia and policy makers, which made possible the widespread dissemination of the clinical practice guidelines. Problems and constraints were also encountered. This evolving public health strategy might be useful for other developing countries.

Objectives: The aim of this study was to present the first four collaborative health technology assessment (HTA) processes on health technologies of different types and life cycles targeted toward diverse HTA users and facilitators, as well as the barriers of these collaborations.

Methods: Retrospective analysis, through four case studies, was performed on the first four collaboration experiences of agencies participating in the EUnetHTA Joint Action project (2010–12), comprising different types and life cycles of health technologies for a diverse target audience, and different types of collaboration. The methods used to initiate collaboration, partner contributions, the assessment methodology, report structure, time frame, and factors acting as possible barriers to and facilitators of this collaboration were described.

Results: Two ways were used to initiate collaboration in the first four collaborative HTA processes: active brokering of information, so-called “calls for collaboration,” and individual contact between agencies after identifying a topic common to two agencies in the Planned and Ongoing Projects database. Several success factors are recognized: predefined project management, high degree of commitment to the project; adherence to timelines; high relevance of technology; a common understanding of the methods applied and advanced experience in HTA; finally, acceptance of English-written reports by decision makers in non–English-speaking countries. Barriers like late identification of collaborative partners, nonacceptance of English language and different methodology of assessment should be overcome.

Conclusions: Timely and efficient, different collaborative HTA processes on relative efficacy/effectiveness and safety on different types and life cycles of health technologies, targeted toward diverse HTA users in Europe are possible. There are still barriers to overcome.

Objectives: The aim of this study was to develop and apply an instrument to map the level of health technology assessment (HTA) development at country level in selected countries. We examined middle-income countries (Argentina, Brazil, India, Indonesia, Malaysia, Mexico, and Russia) and countries well-known for their comprehensive HTA programs (Australia, Canada, and United Kingdom).

Methods: A review of relevant key documents regarding the HTA process was performed to develop the instrument which was then reviewed by selected HTAi members and revised. We identified and collected relevant information to map the level of HTA in the selected countries. This was supplemented by information from a structured survey among HTA experts in the selected countries (response rate: 65/385).

Results: Mapping of HTA in a country can be done by focusing on the level of institutionalization and the HTA process (identification, priority setting, assessment, appraisal, reporting, dissemination, and implementation in policy and practice). Although HTA is most advanced in industrialized countries, there is a growing community in middle-income countries that uses HTA. For example, Brazil is rapidly developing effective HTA programs. India and Russia are at the very beginning of introducing HTA. The other middle-income countries show intermediate levels of HTA development compared with the reference countries.

Conclusions: This study presents a set of indicators for documenting the current level and trends in HTA at country level. The findings can be used as a baseline measurement for future monitoring and evaluation. This will allow a variety of stakeholders to assess the development of HTA in their country, help inform strategies, and justify expenditure for HTA.

Objectives: The aim of this study was to estimate the relationship between the financial impact of a new drug and the recommendation for reimbursement by the Australian Pharmaceutical Benefits Advisory Committee (PBAC).

Methods: Data in the PBAC summary database were abstracted for decisions made between July 2005 and November 2009. Financial impact—the upper bound of the values presented in the PBAC summary database—was categorized as ≤A$0, >A$0 up to A$10 million, A$10 million up to A$30 million, and >A$30 million per year. Descriptive, logistic, survival, and recursive partitioning decision analyses were used to estimate the relationship between the financial impact of a new drug indication and the recommendation for reimbursement. Multivariable analyses controlled for other clinical and economic variables, including cost per quality-adjusted life-year gained.

Results: Financial impact was a significant predictor of the recommendation for reimbursement. In the logistic analysis, the odds ratios of reimbursement for drug submissions with financial impacts ≥A$10 million to ≥A$30 million or >A$0 to <A$10 million compared with ≤A$0 were 0.12 (95 percent confidence interval [CI]: 0.03–0.51) and 0.16 (95 percent CI: 0.04–0.60), respectively. In the recursive partition decision analysis, the first split of the data was for submissions with a positive financial impact compared with those with a zero or negative financial impact.

Conclusions: In Australia, financial impact on the drug budget is an important determinant of whether a new drug is recommended for reimbursement when cost-effectiveness estimates and other clinical and economic variables are controlled.

Objective: This study describes the process of production, findings for a policy brief on Increasing Access to Skilled Birth Attendance, and subsequent use of the report by policy makers and others from the health sector in Uganda.

Methods: The methods used to prepare the policy brief use the SUPPORT Tools for evidence-informed health policy making. The problem that this evidence brief addresses was identified through an explicit priority setting process involving policy makers and other stakeholders, further clarification with key informant interviews of relevant policy makers, and review of relevant documents. A working group of national stakeholder representatives and external reviewers commented on and contributed to successive drafts of the report. Research describing the problem, policy options, and implementation considerations was identified by reviewing government documents, routinely collected data, electronic literature searches, contact with key informants, and reviewing the reference lists of relevant documents that were retrieved.

Results: The proportion of pregnant women delivering from public and private non-profit facilities was low at 34 percent in 2008/09. The three policy options discussed in the report could be adopted independently or complementary to the other to increase access to skilled care. The Ministry of Health in deliberating to provide intrapartum care at first level health facilities from the second level of care, requested for research evidence to support these decisions. Maternal waiting shelters and working with the private-for-profit sector to facilitate deliveries in health facilities are promising complementary interventions that have been piloted in both the public and private health sector. A combination of strategies is needed to effectively implement the proposed options as discussed further in this article.

Conclusions: The policy brief report was used as a background document for two stakeholder dialogue meetings involving members of parliament, policy makers, health managers, researchers, civil society, professional organizations, and the media.

Objectives: The aim of this study was to explore factors that influenced decision making in the assessment of new health technology in Korea.

Methods: We analyzed the decision-making results of the Committee for New Health Technology Assessment (CnHTA) on fifty-three new nondrug health technologies in Korea from July 2007 to December 2010. The scope of the committee was mainly limited to safety and efficacy/effectiveness, and every decision was based on a systematic review of the literature. The committee was composed of healthcare professionals, policy makers, lawyers, and representatives from nongovernmental organizations. Decisions made on therapeutic interventions were included, while those on diagnostic procedures were excluded.

Results: Factors that positively influenced decisions were lower complication rate than existing technology, similar or greater effectiveness compared with existing technology, ability to save critical organs, absence of alternative intervention, decreased invasiveness, expansion of patient's set of choices, and similarity to the mechanism of existing technology. Factors that negatively influenced decisions were higher complication rates than existing technology, lower effectiveness than comparable technology, low levels of evidence, unknown mechanisms of intervention, inconsistency, lack of long-term outcomes, lack of comparative data, nonstandardized technology, heterogeneity between control and treatment, excessively diverse indications, and nongeneralizability.

Conclusions: This qualitative analysis of past decision-making results provided us with clues on the values that decision makers on the Korean CnHTA considered in terms of safety and effectiveness. These findings will help us develop appraisal guidelines and enhance the objectivity of decision-making processes in Korea.

Objectives: The aim of this study was to examine the use of implicit and explicit Bayesian methods in health technology assessments and to identify whether this has changed over time.

Methods: A review of all health technology assessment (HTA) reports of secondary research published by the UK National Institute of Health Research (NIHR) between 1997 and 2011. Data were extracted on the use and implementation of Bayesian methods, whether defined as such by the original authors (i.e., explicit) or not (i.e., implicit).

Results: A total of 155 of 375 (41 percent) NIHR HTA reports, identified as relevant to this review, contained a Bayesian analysis. Of these, 128 (83 percent) contained an implicit Bayesian analysis, 3 (2 percent) an explicit Bayesian analysis and 24 (15 percent) both implicit and explicit Bayesian analyses. Of the twenty-seven reports that explicitly used Bayes theorem, only six included prior information in the form of (informative) prior distributions. Over time, the percentage of HTA reports that used Bayesian (implicit and/or explicit) methods increased from 0 percent in 1997 to nearly 80 percent in 2011.

Conclusions: This review has shown that there has been an increase in the use of Bayesian methods in HTA, which is likely to be a result of the increase in freely available resources to implement the approach. Areas where Bayesian methods have the potential to advance healthcare evaluations in the future are considered in the discussion.

Objective: The aim of this study was to investigate malaria elimination in Ethiopia. Ethiopia has planned to eliminate malaria by 2015 in areas of unstable malaria transmission and in the entire country by 2020. However, there is a shortage and maldistribution of the health workforce in general and malaria experts in particular. Training, motivating, and retaining the health workforce involved in malaria control is one strategy to address the shortage and maldistribution of the health workforce to achieve the goal of elimination.

Methods: Policy options include the following: (i) in-service training (educational outreach visits, continuing education meetings and workshops, audit and feedback, tailored interventions, and guideline dissemination) may improve professional practice; (ii) recruiting and training malaria specialists together with academic support, career guidance, and social support may increase the number of malaria experts; and (iii) motivation and retention packages (such as financial, educational, personal, and professional support incentives) may help motivate and retain malaria professionals.

Results: Implementation strategies include the following: (i) massive training of health personnel involved in malaria elimination and malaria experts (requiring special training) at different levels (national, sub-national, District & community levels), and (ii) recruiting highly qualified health personnel and retention and motivation mechanisms are needed.

Conclusions: The lack of adequately trained human resources and personnel attrition are major challenges to effectively implement the planned multi-faceted malaria elimination by 2020 strategy in Ethiopia. Although a reduction in malaria incidence has been observed in the last 3-4 years, maintaining this success and achieving the malaria elimination goal with the present human resource profile will be impossible. A clear strategy for developing the capacity of the health workers in general, and malaria experts in particular, and retaining and motivating staff are crucial for malaria control and elimination.

Objectives: The use of value of information methods to inform trial design has been widely advocated but there have been few empirical applications of these methods and there is little evidence they are widely used in decision making. This study considers the usefulness of value of information models in the context of a real clinical decision problem relating to alternative diagnostic strategies for patients with a recent non-ST elevated myocardial infarction.

Methods: A pretrial economic model is constructed to consider the cost-effectiveness of two competing strategies: coronary angiography alone or in conjunction with fractional flow reserve measurement. A closed-form solution to the expected benefits of information is used with optimal sample size estimated for a range of models reflecting increasingly realistic assumptions and alternative decision contexts.

Results: Fractional flow reserve measurement is expected to be cost-effective with an incremental cost-effectiveness ratio of GBP 1,621, however, there is considerable uncertainty in this estimate and consequently a large expected value to reducing this uncertainty via a trial. The recommended sample size is strongly affected by the reality of the assumptions of the expected value of information (EVI) model and the decision context.

Conclusions: Value of information models can provide a simple and flexible approach to clinical trial design and are more consistent with the constraints and objectives of the healthcare system than traditional frequentist approaches. However, the variation in sample size estimates demonstrates that it is essential that appropriate model parameters and decision contexts are used in their application.

Pharmaceutical manufacturers, regulators, patients, providers, and payers all have a shared interest in improving health outcomes for patients with cancer. Each plays an important role in helping to achieve this common goal. Pharmaceutical manufacturers seek to develop new medicines that are supported by robust and clinically meaningful evidence of their safety, efficacy, and effectiveness. Regulators authorize these medicines based on evaluations of their safety and efficacy. Patients and providers together make treatment decisions and desire access to the most effective treatment options. Payers appraise new medicines with the goal of ensuring access to those medicines that constitute efficient uses of healthcare expenditure. Profits generated from the sale of the medicines provide a return to the manufacturer, which helps to drive continued research and development in an effort to improve patient health outcomes and societal well-being. Many payers have initiated health technology assessment (HTA) activities to inform decision making in light of the rising costs of health care. Given the financial constraints imposed as a result of the global economic crisis, HTAs are likely to become increasingly important as payers seek value for money solutions to major health problems. Successful collaboration and aligning incentives across stakeholders is critical to ensuring that patients are able to access the most effective medicines.