Objectives: Economic evaluation (EE) is an accepted element of decision making and priority setting in healthcare. As the number of published EEs grows, so does the number of systematic reviews (SRs) of EEs. Although search methodology makes an important contribution to SR quality, search methods in reviews of EEs have not been evaluated in detail. We investigated the resources used to identify studies in recent, published SRs of EEs, and assessed whether the resources reflected recommendations.

Methods: We searched MEDLINE for SRs of EEs published since January 2013 and extracted the following from eligible reviews: databases searched, health technology assessment (HTA) sources searched, supplementary search techniques used. Results were compared against the minimum search resources recommended by National Institute for Health and Care Excellence (NICE) (MEDLINE, Embase, NHS EED, EconLit) for economic evidence for single technology appraisals, and resource types suggested in the summary of current best evidence from SuRe Info (economic databases, general databases, HTA databases, HTA agency Web pages, gray literature).

Results: Sixty-five SRs met the inclusion criteria; data were extracted from forty-two. Five reviews (12 percent) met or exceeded the NICE recommended resources. Nine reviews (21 percent) searched at least four of the five types of resource recommended by SuRe Info. Five reviews (12 percent) searched all five. Twenty-three reviews (55 percent) did not meet the NICE recommendations or four of five of the SuRe Info recommended resource types. Search reporting was frequently unclear or incorrect.

Conclusions: Searches conducted for the majority of recently published SRs of EEs do not meet two published approaches.

This article describes the characteristics of the health system and reviews the history of health technology assessment (HTA) in Iran, including its inception, processes, challenges, and lessons learned. This study was conducted by analyzing existing documents, reports, and guidelines related to HTA and published articles in the field. HTA in Iran has been established since the late 2000s and was first introduced as a secretariat by the Deputy of Health at the Ministry of Health and Medical Education. The mission of the HTA office is to systematically assess technologies to improve evidence-informed decision making. Despite its 10 years of existence, HTA in Iran still faces some challenges. The most pressing problems currently facing HTA in Iran include conflicts of interest among researchers performing the HTAs, the absence of a systematic structure for identifying and introducing new technologies, the lack of interest in HTA results among high-level policy makers, and the lack of external oversight for HTA projects.

Objectives: The aim of this study was to assist and facilitate introduction and development of a health technology assessment (HTA) program in Romania.

Methods: Mentoring of an initiative group in Romania was provided by an HTA program in Canada. Mentoring activities included provision of HTA materials, participation in local seminars, facilitating contact with HTA and funding organizations, and in-house training of a professional from Romania.

Results: Since 1998, when the relationship was initiated, the Romanian group has been successful in developing an understanding of HTA and awareness of its utility among various decision-makers in the health system. Currently, although the need for HTA in Romania exists and interest in developing this activity has been officially expressed, HTA is still early in its development phase. The mentoring support helped to identify and define the need for HTA in Romania. Continuation of the existing relationship can be expected to strengthen the expertise in this country. However, while mentoring has been a valuable activity, it is not, by itself, sufficient to ensure development of an HTA program in Romania. The actions and decisions that could lead to implementing HTA in Romania depend on the local context.

Conclusions: Mentoring services assisted the initiative group in promoting HTA in Romania. The implementation of HTA in Romania has not happened yet, and efforts need to continue to sustain the existing momentum. However, success in implementing an HTA program will depend on essential factors such as local political, economical, and educational support for this initiative and others like it.

Objectives: To expand care for chronic haemodialysis (HD) patients throughout England and Wales by studying two aspects of service delivery that are important: to identify relative performance of haemodialysis satellite units (HDSUs), and understand the factors that influence the performance. As a first step toward these aspects, this work reports a study of apparent comparative efficiency in the delivery of HDSUs and demonstrates the potential of data envelopment analysis (DEA).

Methods: DEA was applied to data obtained from a national survey of the organizational structures and processes of delivering care at HDSUs in England and Wales.

Results: DEA was found to be a judicious approach for performance assessment of HDSUs, although valid results depend on appropriate model specification and quality of data available. The available data were not of sufficient comprehensiveness or quality to produce definitive results but suggested that overall efficiency could improve; these data suggested by as much as 10% overall (mean efficiency score 90%) and variably within the sample (46 [65%] that HDSUs were potentially inefficient, the lowest unit scoring 38%).

Conclusions: Addressing questions raised by comparative inefficiency could help plans to improve capacity to deal with the growing demand for HD delivered in HDSUs. The application was an important start and needs to be followed by further research to establish model validity and obtain authoritative results.The authors thank HDSU staff who participated in the national satellite survey and colleagues contributing to the main project “An evaluation of the costs and effectiveness of and quality of care of renal replacement therapy provision in renal satellite units in England and Wales.” Particular thanks to Alison Armitage, Tricia Nicholson, and Joy Townsend. Funding was provided by the NHS Research and Development Health Technology Assessment Programme and South East NHS Executive Research and Development Directorate. The opinions and any errors made are the authors' responsibility alone.

Background and Objectives: Horizon scanning systems need to handle a wide range of sources to identify new or emerging health technologies. The objective of this study is to develop a validated Medline bibliographic search strategy (PubMed search engine) to systematically identify new or emerging health technologies.

Methods: The proposed Medline search strategy combines free text terms commonly used in article titles to denote innovation within index terms that make reference to the specific fields of interest. Efficacy was assessed by running the search over a period of 1 year (2009) and analyzing its retrieval performance (number and characteristics). For comparison purposes, all article abstracts published during 2009 in six preselected key research journals and eight high impact surgery journals were scanned. Sensitivity was defined as the proportion of relevant new or emerging technologies published in key journals that would be identified in the search strategy within the first 2 years of publication.

Results: The search yielded 6,228 abstracts of potentially new or emerging technologies. Of these, 459 were classified as new or emerging (383 truly new or emerging and 76 new indications). The scanning of 12,061 journal abstracts identified 35 relevant new or emerging technologies. Of these, twenty-nine were located within the Medline search strategy during the first 2 years of publication (sensitivity = 83 percent).

Conclusions: The current search strategy, validated against key journals, has demonstrated to be effective for horizon scanning. Even though it can require adaptations depending on the scope of the horizon scanning system, it could serve to simplify and standardize scanning processes.

Objectives: A new decision-making process was set up by the Austrian Ministry of Health to regulate coverage of new proposed Extra Medical Services (EMS; German: Medizinische Einzel-Leistung [MEL]) in 2008. As part of the annual decision-making process an independent academic institution (LBI-HTA) is evaluating relevant evidence on these new technologies and provides HTAs, including evidence-based recommendations for decision makers.

Methods: About ten EMS assessments are performed annually by the LBI-HTA simultaneously between January and March. Each peer-reviewed report consists of a systematic literature review and critical appraisal of evidence using the GRADE methodology. The generation of numerous reports of good quality standards within the short timeframe is achieved by a standardized workflow with predefined assignment of tasks for all participants.

Results: In total, the LBI-HTA performed twenty-five EMS assessments on thirty-three different interventions in the last three years. Coverage was recommended with limitation for eleven (33%) interventions, and not recommended for twenty-two (66%) interventions. The federal health commission decided on acceptance or preliminary acceptance of coverage in seven (22%) cases, rejection in eighteen (55%) cases and changed the status to “subject to approval” in seven (24%) cases.

Conclusions: Pre-coverage assessment of new hospital interventions was implemented successfully in Austria. It has proved to be a useful tool to support decision makers with objective evidence when deciding whether or not to reimburse medical services.

Objectives: Preterm birth contributes to a range of healthcare problems amongst infants surmounting to sizeable healthcare costs. Twin pregnancies are at particular risk of preterm birth. The objective of this study was to assess the cost-effectiveness of vaginal progesterone gel for the prevention of preterm birth in twin pregnancies.

Methods: An economic evaluation was conducted alongside a randomized placebo controlled trial (the STOPPIT trial) of vaginal progesterone gel for the prevention of preterm birth in twin pregnancies. Five hundred women were recruited from nine maternity hospitals in the United Kingdom. The outcomes of the economic evaluation were presented in terms of net benefit statistics, cost-effectiveness acceptability curves, generated using the nonparametric bootstrap method, and the expected value of perfect information.

Results: Mean health service costs between the period of randomization and discharge for mother and infant were £28,031 in the progesterone group and £25,972 in the placebo group, generating a mean nonsignificant cost difference of £2,059 (bootstrap mean cost difference £2,334; 95 percent confidence interval: −£5,023, £9,142; p = .33). The probability of progesterone being cost-effective was 20 percent at a willingness to pay threshold of £30,000 per preterm birth prevented. There is little economic justification for conducting further research into the use of vaginal progesterone gel in twin pregnancies for the prevention of preterm birth.

Conclusions: Further studies of preventive interventions for preterm birth more generally are required given the scale of the clinical and economic burden of this condition. These studies should be sufficiently powered for economic endpoints and extend beyond hospital discharge.

In a pretest-posttest panel survey of 595 eligible Maryland physicians practicing family or general medicine, internal medicine, cardiology, or nephrology, perceptions of consensus reports designed to alter medical practice are examined. On a 7-point scale, physicians reported positive or neutral views of descriptors, most favorably rating credible (mean = 2.25) and reliable (mean = 2.41), and least favorably rating biased (mean = 3.79). In a regression analysis of factors influencing changes in practice behavior congruent with consensus recommendations before and 1 year after the release of a consensus report on hypertension (8), these perceptions were not significant determinants. The strongest predictor of congruent practice behavior a year after the report was published was congruent practice behavior just prior to the report's release, and the second strongest predictor was perceived influence of the report's sources/sponsors.

We examined a screening program for colorectal cancer in South Australia in terms of its overall direct costs to society and costs to participants. The best estimate of the cost per cancer detected was $18,924 (Australian dollars). Potential improvements in health outcome through screening are discussed in light of these costs.

Samples and methods vary in constructing birthweight charts. Introduction of ultrasound dating affects the distribution of gestation, increases the proportion of preterm births, and reduces postterm and small-for-gestational-age (SGA) births. The need for standardized charts is emphasized. Preferably such charts ought to be sex- and parity-specific, also taking into account the mother's previous pregnancy outcome in terms of birthweight. The risks associated with being bom SGA involve various morbidity as well as short- and long-term survival.

The use of randomized control trials to assess the usefulness of therapeutic drugs over the last half century has brought significant benefits to patient care. The full potential benefits, however, have been only partially fulfilled because available data are frequently poorly used. Meta-analysis has emerged as an important tool for combining clinical evidence. Several examples are presented that compared the results of cumulative meta-analysis of randomized control trials with clinical expert recommendations. These comparisons demonstrated that clinical expert recommendations are often not synchronized with accumulating evidence, and this lack of recognition often resulted in delays in the acceptance of effective drugs and the slow abandonment of possibly harmful therapeutic practices. The problems of inappropriate therapeutic drug use will only intensify as new drugs are introduced and new uses for established drugs are proposed. The rational use of therapeutic drugs can be achieved only through the routine use of meta-analysis on high-quality clinical data. Some suggestions are made to improve the quality of the original research and the ways of assembling meta-analyses and disseminating their results.

The principles of economic evaluation are increasingly accepted by clinicians and policy makers as evidence from a significant number of studies becomes available to support their decisions. However, methods of assessment still need to be improved. This paper reports a comprehensive review of methodological challenges in the economic evaluation of diagnostic technology, where such challenges are more evident. This review formed the basis for a prioritized research agenda, with four main areas: modeling techniques for dealing with complexity; measures of the opportunity cost of shared resources; techniques for eliciting decision makers' utility functions for diagnostic tests; and ways of assessing the robustness of decisions. A number of methodoligical solutions are proposed, aimed at capturing elements and relationships that are usually neglected and fully recognizing the presence of an inductive cognitive component in decision-making processes.

Background: Uncertainty about the applicability of controlled trial findings is an increasing concern for clinicians and policy decision makers. This study aimed to determine whether information reported in studies included in systematic reviews was adequate enough to assess their applicability.

Methods: We used the databases of four recently conducted systematic reviews on the comparative efficacy and safety of second-generation antidepressants, inhaled corticosteroids, Alzheimer's drugs, and targeted immune modulators. We developed and pilot-tested a questionnaire to assess the adequacy of reporting with respect to seven previously validated criteria of study design that distinguish explanatory from pragmatic studies. For each of the 137 included studies, two reviewers independently assessed the adequacy of reporting.

Results: Overall, only 12 percent of the included studies provided sufficient information to reliably distinguish explanatory from pragmatic studies. The areas with the greatest lack of reporting were the setting of the study, methods of adverse event assessment, and sample size considerations to determine a minimally important difference from a patient perspective.

Conclusions: Substantial shortcomings in reporting exist in aspects of study design important to determine whether a study is applicable to specific populations of interest.

Objectives: Nonpublication of results of clinical trials can contribute to inappropriate medical decisions. The primary aim of this systematic review was to investigate publication delays between conference abstracts and full journal publications from randomized controlled trial results of new anticancer agents for breast cancer. The review was restricted to anticancer agents previously, or due to be, appraised in the United Kingdom by the National Institute for Health and Clinical Excellence. A secondary objective was to identify whether there are any apparent biases in the publication and reporting of these trials.

Methods: We searched six electronic databases up to August 2007, including Medline and the Cochrane Library. Two reviewers independently selected studies, extracted and assessed the data.

Results: Six anticancer treatments were identified: docetaxel, paclitaxel, trastuzumab, gemcitabine, lapatinib, and bevacizumab. Of eighteen included trials, only four publications from three trials reported the same outcomes in both abstract and full publication. Time delays ranged from 5 to 19 months. Eleven trial abstracts were still without a full publication at the end of our searches, varying from 3 to 38 months since abstract publication. Observational analysis revealed no particular publishing biases.

Conclusions: Whereas delays in publication appear reasonable over a period of months, many were not published in full over a period of years and others would appear to be unlikely to ever be published. Further research should investigate the impact of publication delays on the availability of new drug treatments in clinical practice.

Background: The way people use health technology assessment (HTA) terms varies considerably across Europe. Such variation can lead to misunderstandings when reading HTA reports from different contexts. This work is one of the outputs of the EUnetHTA Project and was undertaken between 2006 and 2008.

Objectives: The aim of this study was to develop a glossary of HTA adaptation terms to help reduce the misunderstandings of terms used in HTA reports from contexts other than the reader's own.

Methods: Several HTA glossaries were examined to identify ways in which an additional glossary could offer readers something new and to identify adaptation terms for inclusion. Twenty-eight European HTA organizations provided terms for the glossary and drafted descriptions and examples of how each specific term was used in their particular setting. The organizations then commented on the descriptions provided by the other groups and worked together to draft a single description for certain terms.

Results: A glossary of HTA adaptation terms was developed. It provides a comprehensive range of descriptions, examples, and comments for forty-two potentially confusing HTA terms related to adaptation.

Conclusions: This glossary will be a valuable resource for European HTA agencies when reading HTA reports produced in different contexts and for adapting HTA reports produced in other countries. The glossary will help improve understanding and help facilitate the adaptation process.

Objectives: Many European countries perform rapid assessments of the relative effectiveness (RE) of pharmaceuticals as part of the reimbursement decision making process. Increased sharing of information on RE across countries may save costs and reduce duplication of work. The objective of this article is to describe the development of a tool for rapid assessment of RE of new pharmaceuticals that enter the market, the HTA Core Model® for Rapid Relative Effectiveness Assessment (REA) of Pharmaceuticals.

Methods: Eighteen member organisations of the European Network of Health Technology Assessment (EUnetHTA) participated in the development of the model. Different versions of the model were developed and piloted in this collaboration and adjusted accordingly based on feedback on the content and feasibility of the model.

Results: The final model deviates from the traditional HTA Core Model® used for assessing other types of technologies. This is due to the limited scope (strong focus on RE), the timing of the assessment (just after market authorisation), and strict timelines (e.g. 90 days) required for performing the assessment. The number of domains and assessment elements was limited and it was decided that the primary information sources should preferably be a submission file provided by the marketing authorisation holder and the European Public Assessment Report.

Conclusions: The HTA Core Model® for Rapid REA (version 3.0) was developed to produce standardised transparent RE information of pharmaceuticals. Further piloting can provide input for possible improvements, such as further refining the assessment elements and new methodological guidance on relevant areas.