Objectives: The aim of this study was to evaluate the extent of reporting necessary information in published health economic research in World Health Organization Eastern Mediterranean Countries (WHO EMC).

Methods: A systematic literature search was conducted using PubMed and Google Scholar to identify pharmacoeconomic studies conducted in WHO EMC. The inclusion criteria for the studies were: (i) original studies, (ii) compared pharmaceutical services or drugs, (iii) conducted in WHO EMC, (iv) manuscript published in English. The articles were reviewed by two independent reviewers using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist.

Results: A total of seventeen studies were included, each of which were published in seventeen different journals. The mean CHEERS checklist score was 16 ± 4. Most studies were published in journals outside WHO EMC (n = 12; 71 percent). Cost-effectiveness (n = 5; 29 percent) and cost-utility analyses (n = 5; 29 percent) were the most frequently used methods of economic evaluation.

Conclusions: Pharmacoeconomic studies in WHO EMC are limited and sometimes incomplete. Economic evaluation of pharmaceuticals should be encouraged in WHO EMC to ensure the appropriate allocation of healthcare resources.

Objectives: This article provides a detailed understanding of the differences in selected formulary submission guidelines supplied by various health technology assessment (HTA) agencies and indicates how these differences can impact the evidence base used to populate the HTA.

Methods: Detailed summaries of the recommended methods for evidence generation, organized by topic areas relevant for clinical and economic data, for twelve countries in Europe, North America, and Australia where HTA processes are well developed were prepared. Using these summaries, we provide examples of the likely impact these differences in recommended methods could have on the evidence base used to evaluate new health technologies.

Results: Areas where recommendations differed included methodologies for systematic literature reviews (e.g., preferred databases and study designs for inclusion); selection of appropriate comparators; guidance on critical appraisal and synthesis of clinical evidence; appropriate sources for health value measures, resource use, and cost data; and approaches to uncertainty analyses. Performing literature searches that capture all relevant studies and then creating subsets of the literature based on a listing of country-specific requirements could allow for direct comparison of the evidence bases associated with the different guidelines.

Conclusions: If the formulary submission guidelines were followed as written, different (although overlapping) bodies of evidence likely would be generated for each country, which could contribute to disparate assessments and recommendations. This comparison of the formulary submission guidelines could contribute to an understanding of why clinical and reimbursement decisions vary across countries.

Objectives: Several studies have reported multiple barriers to and facilitators for the uptake of health technology assessment (HTA) information by policy makers. This study elicited, using best-worst scaling (BWS), the most important barriers and facilitators and their relative weight in the use of HTA by policy makers.

Methods: Two BWS object case surveys (one for barriers, one for facilitators) were conducted among sixteen policy makers and thirty-three HTA experts in the Netherlands. A list of twenty-two barriers and nineteen facilitators was included. In each choice task, participants were asked to choose the most important and the least important barrier/facilitator from a set of five. We used Hierarchical Bayes modeling to generate the mean relative importance score (RIS) for each factor and a subgroup analysis was conducted to assess differences between policy makers and HTA experts.

Results: The five most important barriers (RIS > 6.00) were “no explicit framework for decision-making process,” “insufficient support by stakeholders,” “lack of support,” “limited generalizability,” and “absence of appropriate incentives.” The six most important facilitators were: “availability of explicit framework for decision making,” “sufficient support by stakeholders,” “appropriate incentives,” “sufficient quality,” “sufficient awareness,” and “sufficient support within the organization.” Overall, perceptions did not differ markedly between policy makers and HTA experts.

Conclusions: Our study suggests that barriers and facilitators related to “policy characteristics” and “organization and resources” were particularly important. It is important to stimulate a pulse at the national level to create an explicit framework for including HTA in the decision-making context.

Objectives: The diffusion of cost-utility analyses (CUAs) through the medical literature was examined, documenting visible patterns and determining how they correspond with expectations about the diffusion of process innovations.

Methods: This study used 539 CUAs from a registry. It includes data elements comprising year of publication, the research center in which the study was performed, the clinical area covered by the CUA, and the specific journal. Finally, each paper was assigned to a journal type that could be one of the three categories: health services research, general medicine, or clinical specialty.

Results: When the average number of publications is plotted against time, the plot reveals an S-shaped curve. It appears that, whereas CUAs initially were published more frequently in general medical or health services research journals, there was a clear increase in the diffusion of CUA into subspecialty journals over time. The concentration ratio for research centers as measured by the Herfindhal–Hirschman Index decreased over time.

Conclusions: The spread of CUA through the medical literature follows patterns identified for the diffusion of other new technologies and processes. Future research should focus on what impact this spread has had on the practice of medicine and formulation of health policy.

Objectives: Colorectal cancer is one of the most commonly occurring cancers in industrialized countries, yet appears to be amenable to screening. Amongst the many possible protocols is once-only screening by means of flexible sigmoidoscopy. This protocol is currently being investigated in a UK multicenter trial and the study provides estimates of the expected resource costs.

Methods: The direct health care costs of sigmoidoscopy and of all subsequent procedures were estimated from an audit of resource use of approximately 40,000 patients at thirteen centers. Patient-borne costs were estimated from the results of surveys conducted at twelve of these centers.

Results: The health service costs of a flexible sigmoidoscopy was estimated at £56. The total costs of screening (including private costs) averaged £82 per person screened, although costs varied by center. The total health service costs of screening and subsequent management averaged approximately £91 per person screened, again with variations between centers.

Conclusions: Even within a strict trial protocol, intercenter variation in costs can be detected, ascribable to variability in local management practices, local yield, and local patient-borne costs. Other recent estimates of flexible sigmoidoscopy costs vary widely. As these costs form the basis of technology assessment simulation models which, in turn, inform policy, obtaining realistic cost estimates within the appropriate health care setting is of paramount importance.

Objectives: The aim of this study was to analyze the current status of population screening for colon/rectum cancer in Europe to compare the different strategies, the coverage, the existence of pilot experiences, regional coverages, and the risk factors considered in each strategy.

Methods: A comprehensive, systematic search was performed in the literature for documents addressing population screening for colon/rectum cancer in Europe. An ad hoc questionnaire was prepared including questions considered relevant. The questionnaire was reviewed by experts in the area. To identify key informants, colleague members of the International Network of Agencies for Health Technology Assessment (INAHTA), participants in the EUnetHTA project, or representatives of the ministries of health of the different European countries were contacted. The information provided by key informants was checked with information directly obtained from the ministries of health, gray literature, and research documents.

Results: An 88 percent response rate was obtained. In countries for which no questionnaire data were collected, information was directly retrieved from the Web sites of the corresponding ministries. Four countries were found to perform population screenings: Austria, France, Germany, and the United Kingdom. However, they used different strategies. Five countries had begun regional or local strategies: Denmark, Finland, Italy, Spain, and Switzerland, and two additional countries (the Netherlands and Norway) reported ongoing research studies intended to determine the best strategy to implement a population-based screening program. Differences were found in age range, procedure chosen, and follow-up period.

Conclusions: Even though the European Council recommended a wider implementation of population screening for colon/rectum cancer, our results suggest that this recommendation continues to be valid. The differences found in screening strategies (in terms of age range, procedures, risk factors considered, and follow-up periods) are not warranted by the results obtained in research studies or regional-national cancer registries.

Objectives: The aim of this study was to develop a decision support tool to assess the potential benefits and costs of new healthcare interventions.

Methods: The Canadian Partnership Against Cancer (CPAC) commissioned the development of a Cancer Risk Management Model (CRMM)—a computer microsimulation model that simulates individual lives one at a time, from birth to death, taking account of Canadian demographic and labor force characteristics, risk factor exposures, and health histories. Information from all the simulated lives is combined to produce aggregate measures of health outcomes for the population or for particular subpopulations.

Results: The CRMM can project the population health and economic impacts of cancer control programs in Canada and the impacts of major risk factors, cancer prevention, and screening programs and new cancer treatments on population health and costs to the healthcare system. It estimates both the direct costs of medical care, as well as lost earnings and impacts on tax revenues. The lung and colorectal modules are available through the CPAC Web site (www.cancerview.ca/cancerrriskmanagement) to registered users where structured scenarios can be explored for their projected impacts. Advanced users will be able to specify new scenarios or change existing modules by varying input parameters or by accessing open source code. Model development is now being extended to cervical and breast cancers.

Objectives: Legal analysis can highlight important issues that are relevant when deciding whether a medical technology should be implemented or reimbursed. Literature and studies show that even though the law is an acknowledged part of health technology assessment (HTA), legal issues are rarely considered in practice. One reason for this may be the lack of knowledge about the diversity of legal issues that are relevant for HTA. Therefore, this contribution aims primarily to identify and then explain the relevant legal issues in HTA. This study offers a framework for identifying the legal issues in HTAs in different jurisdictions and provides a basis for further research.

Methods: After extensive literature search, the authors review Swiss health law to identify legal issues that are relevant to HTA. The authors then categorize these legal issues using a framework with an inside and outside perspective. Finally, they explain a selection of these legal issues with several examples.

Results: This study reveals numerous legal issues that are relevant for HTA and underlines the necessity of incorporating legal analysis in HTAs. The suggested perspectival framework in this study provides a basis to structure the legal analysis. The identified legal issues are relevant in other countries and the perspectival framework is transferable to other jurisdictions.

Conclusions: The article underlines the importance of in-depth discussion about the role of law in HTA. It provides a structured overview of the legal issues in HTA and suggests a development of more concrete instruments toward a standardized legal technology assessment.

Objectives: The aim of this study was to evaluate available knowledge and identify knowledge gaps within the field of oral and maxillofacial surgery, by systematically collecting and evaluating systematic reviews. Twelve specific domains were selected: surgical removal of teeth, antibiotic and corticosteroid prophylaxis, orofacial infections, dental and facial trauma, orthognathic surgery, reconstructive surgery, benign tumors, cysts, premalignant lesions, oral complications of treatment of malignant tumors, hyperbaric oxygen therapy, temporomandibular joint surgery, cost effectiveness of different surgical treatments, and ethics.

Methods: The literature search, covering four databases, was conducted during September 2014: PubMed, The Cochrane library, Centre for Reviews and Dissemination and EBSCO dentistry and oral science source. Retrieved systematic reviews were quality assessed by AMSTAR.

Results: In all, 1,778 abstracts were identified, of which 200 met the inclusion criteria. Forty-five systematic reviews were assessed as of high to moderate quality. The results disclosed some existing evidence in a few domains, such as surgical removal of teeth and implant survival after sinus lifts. However, in all domains, the search revealed a large number of knowledge gaps. Also of concern was the lack of data regarding health economics and ethics.

Conclusions: In conclusion, there is a need for well-conducted clinical research in the fields of oral and maxillofacial surgery.

Objectives: To examine the production of Health Technology Assessments (HTAs) with economic evaluations (EEs) conducted by Canadian HTA agencies.

Methods: This research used a three-step approach: (i) the Web sites of five Canadian organizations promoting HTA were searched to identify HTA reports with EEs; (ii) HTA agencies were surveyed to verify that our information was complete with respect to HTA activities and to describe the factors that influence the HTA process in Canada (i.e., selection of HTA topics, execution, dissemination of results and future trends); (iii) HTAs with EEs were appraised in terms of study design, retrieval of clinical and economic evidence, resource utilization and costing, effectiveness measures, treatment of uncertainty as well as presence of a budget impact analysis (BIA), and policy recommendations.

Results: Two hundred forty-nine HTA reports were identified of which 19 percent included EEs (n = 48). Decision analytic techniques were used in approximately 75 percent of the forty-eight EEs and probabilistic sensitivity analyses were commonly used by all agencies to deal with parameter uncertainty. BIAs or policy recommendations were given in 50 percent of the evaluations. Differences between agencies were observed in terms of selection of topics, focus of assessment and production of HTA (e.g., in-house activities). Major barriers to the conduct of HTAs with EEs were capacity, a lack of interest by decision makers and a lack of robust clinical information.

Conclusions: The results of this research point to the need for increased HTA training, collaboration, evidence synthesis, and use of pragmatic “real world” evaluations.

Objectives: The aim of this study was to explore the needs and requirements of decision makers in our regional healthcare system for health technology assessment (HTA) products to support portfolio development planning for a new HTA agency in Madrid, Spain.

Methods: A Delphi study was conducted during 2003. Questionnaires were developed based on a review of products and services offered by other agency members of the International Network of Agencies for Health Technology Assessment, and included preference and prioritization questions to evaluate twenty-two different products and services. The initial Delphi panel involved eighty-seven experts from twenty-one public hospitals, eleven primary healthcare centers, six private hospitals, and eight departments of the Regional Ministry of Health of the Community of Madrid.

Results: The global participation rate was 83.9 percent. Ten of the twenty-two possible products were rated of high interest by more than 80 percent of respondents. Important differences in preferences and priorities were detected across different settings. Public hospitals and primary healthcare centers shared a more “micro” perspective, preferring classic technology-centered HTA products, whereas private hospitals and Ministry representatives demanded more “macro” products and services such as organizational model and information system assessments.

Conclusions: The high participation rate supports the representativeness of the results for our regional context. The strategic development of an HTA portfolio based on decision makers’ needs and requirements as identified in this type of exercise should help achieve a better impact on policy development and decision making.

Objectives: The aim of this study, in the context of disinvestment related health technology assessment, is to examine whether analysis of Web 2.0—commercial media output, blogs, and discussion forums—can provide an understanding of media framing, community perspectives, and the sociopolitical aspects of an entrenched technology.

Methods: Thematic analysis of relevant data from fifty-nine media articles, thirty-nine discussion forums, thirteen blogs, and three Facebook pages relating to our case study: public funding for assisted reproductive technology services. Mainstream media and community-based social media responses were compared.

Results: Media responses were narrow, primarily describing emotive individual narratives or the political nexus of interests. Community (including patient) responses were broader including discussion of opportunity cost and vested interests but mostly reflected the polar ends of the debate, diverging strongly for or against disinvestment from public funding.

Conclusion: Web2.0 and media analysis offers an inexpensive method to capture media portrayal, divergent community responses both to that portrayal and independent of it, and insight into the sociopolitical aspects of an entrenched technology undergoing disinvestment debate.

The Danish healthcare services are mainly provided by public sector institutions. The system is highly decentralized. The state has little direct influence on the provision of healthcare services. State influence is exercised through legislation and budget allocations. The main task of the state is to initiate, co-ordinate, and advise. Counties, which run the hospitals, also decide on the placement of services. The hospital sector is controlled within the framework of legislation and global budgets. General practitioners occupy a central position in the Danish healthcare sector, acting as gatekeepers to the rest of the system. The system works well, and its structure has resulted in steady costs of health care for a long period. There is no regulatory mechanism in the Danish health services requiring use of health technology assessment (HTA) as a basis for policy decisions, planning, or administrative procedures. However, since the late 1970s a number of comprehensive assessments of health technology have formed the basis for national health policy decisions. In 1997, after years of public criticism of the quality of hospital care and health technologies, and on the basis of a previously developed national HTA strategy, a national institute for HTA (DIHTA) was established. There seems to be a growing awareness of evidence-based healthcare among health professionals and a general acceptance of health economic analyses as a basis for health policy decision making. This progress is coupled with growing regional HTA activity in the health services. HTA seems to have a bright future in Denmark.

The NHS Health Technology Assessment (HTA) Programme runs an annual process of identifying suggestions for health technology assessment. The objective of this paper is to describe and evaluate the relative importance of the different sources used by the program in 1998 to identify potential priorities. There were four different sources: a) a widespread consultation of healthcare commissioners, providers and consumers; b) research recommendations from systematic reviews; c) reconsidering previous research priorities which had not been taken forward for funding; and d) horizon scanning. Collectively, the four sources generated just over 1,100 HTA suggestions. By far the largest source of suggestions and priorities was the widespread consultation. However, the success rate of this source, in terms of being commissioned, was low. Research recommendations from systematic reviews provided the second largest source of priorities and the best success rate of all sources. Value was found from different sources for different healthcare areas.

Objectives: Although endoscopic ultrasound (EUS) staging of esophageal cancer is established in clinical practice, high-quality evidence about its impact on patient outcomes is not available. This study aims to determine the impact of EUS for esophageal cancer staging on patient management and survival.

Methods: A systematic review was conducted using Medline, PreMedline, Embase, and The Cochrane Library. Included studies were (i) comparative studies reporting survival following EUS esophageal cancer staging, (ii) therapeutic impact studies reporting change in patient management following EUS. The quality of included studies was critically appraised.

Results: One systematic review, five studies reporting therapeutic impact, and two studies reporting patient survival were identified. The design and quality of the therapeutic impact studies varied widely. Management changed in 24–29 percent of patients following EUS staging of esophageal cancer (two studies). No studies provided data on the avoidance of surgery for this indication. One retrospective cohort study with historical control found EUS staging of esophageal cancer improved patient survival; a second study with similar design limitations did not find a survival benefit for EUS staging in patients undergoing resection. These studies had a high potential for bias, limiting the value of these findings.

Conclusions: Two studies provided evidence of a change in patient management following EUS for staging esophageal cancer, a higher level of evidence for a clinical benefit than can be obtained from accuracy studies alone. This evidence contributed to a recommendation for public funding of EUS in staging esophageal cancer in Australia.

Objectives: The evaluation of public health interventions poses some challenges. As a consequence, health technology assessment (HTA) methods for public health interventions (PHI) have to be adapted. This study aimed to summarize the available guidance on methods for HTA of PHI.

Methods: We systematically searched for methodological guidance on HTA of PHIs. Our focus was on research synthesis methods to evaluate effectiveness. Relevant information was synthesized narratively in a standardized way.

Results: Only four guidance documents were identified specifically for HTAs of PHI. The approaches used for HTAs of PHIs are broader and more flexible than those for medical interventions. For this reason, there is a tendency to identify the intervention components and context factors that influence the effectiveness and transferability of an intervention rather than to assess its effectiveness in general. The details in the guidance vary without justification. Unjustified heterogeneity between the different guidance approaches is most pronounced for quality assessment, assessment of applicability, and methods to integrate qualitative and quantitative evidence. Descriptions for the assessment of integrity, heterogeneity, sustainability, context factors, and applicability are often vague.

Conclusions: The heterogeneity in approaches indicates that there is currently no consensus on methods to deal with the challenges of the PHI evaluations. A possible explanation for this may be that the methods are not sufficiently developed, and advantages and disadvantages of a certain method in relation to the research question (e.g., broad/focused) have not yet been sufficiently evaluated.

Objective: The series of papers in this issue was developed to examine the use of health technology assessment in policies toward prevention—specifically toward mass screening—in European countries. The papers actually examined three screening strategies: mammography screening for breast cancer, prostate-specific antigen screening for prostate cancer, and routine ultrasound in normal pregnancy.

Methods: Papers were sought from the member states of the European Union, plus Switzerland. Ultimately, nine acceptable papers were received, and were reviewed, revised, and edited.

Results: Screening is an accepted strategy in many countries for reducing the burden of disease through early detection and intervention. In part, this is because of successful screening programs that have been evaluated and implemented in many countries. At the same time, unevaluated and even useless and harmful screening programs—unjustified medically or economically—are widespread. Health technology assessment could help assure that only effective and cost-effective screening programs are implemented.

Conclusion: The main conclusion is that screening is an important preventive strategy. Any screening program, however, should be carefully assessed before implementation.

Objectives: Many evaluations underestimate the utility associated with diagnostic interventions by failing to capture the nonclinical value of diagnostic information. This is a cause of bias in resource allocation decisions. A study was undertaken to investigate preferences for the assessment of cardiac risk, testing the suitability of conjoint analysis, a multiattribute preference elicitation method, in the field of clinical diagnosis.

Methods: Two conjoint analysis models focusing on selected characteristics of cardiac risk assessment in asymptomatic patients 40–50 years of age were applied to elicit preferences for cardiac risk assessment from samples of general practitioners and the general public in the United Kingdom and Italy. Both models were based on rankings of alternative scenarios, and the results were analyzed using multivariate analysis of variance and an ordered probit model.

Results: In both countries, members of the public attached at least three times more importance to prognostic value (relative to clinical value) than did general practitioners. Significantly different patterns were found in the two countries with regard to other characteristics of the assessment. Variation within samples was partly associated with personal characteristics.

Conclusions: Only a fraction of the value of cardiac risk assessment to individuals and physicians in this study was linked to health outcomes. The study confirmed the appropriateness and validity of conjoint analysis in the assessment of preferences for diagnostic interventions. A wider use of this technique might significantly strengthen the existing evidence-base for diagnostic interventions, leading to a more efficient use of health-care resources.

Objectives: This study reviews the coverage and usefulness of a short-term register, established specifically for health technology assessment of a novel interventional procedure (minimally invasive repair of pectus excavatum, or the Nuss procedure).

Methods: Coverage of the register during 2004–07 was assessed by comparison with Hospital Episodes Statistics (HES) for England. Its usefulness was assessed by comparing safety and efficacy data with the published literature and by feedback from committee members who in 2009 were involved in reviewing NICE's original guidance from 2003.

Results: The register reported 260 cases from thirteen UK hospitals during nearly 9 years. During a coverage evaluation period of 3 years, there were 152 registered Nuss procedures. An additional 246 repairs of pectus excavatum were undertaken in twenty-six previously unidentified hospitals. Of the 246, 23 were Nuss procedures (from two hospitals), 140 were open procedures (from eleven hospitals), and 3 were coding errors. No details were available for eighty cases undertaken at ten hospitals. The quantity of published literature had increased substantially since publication of original guidance in 2003. It related mostly to technical and safety outcomes, whereas the register included patient reported outcomes. The literature and the register reported similar rates of major adverse events such as bar displacement (2–10 percent). Committee members considered that the Register made a useful contribution to guidance development.

Conclusions: This study shows that a register set up to support a health technology assessment process can produce useful data both about safety and about patient-reported outcomes. Coverage may be improved by active follow-up based on routine hospital statistics. Improvement in coding for new procedures is needed in the United Kingdom.