KDTD (Turkish Evidence-Based Medicine Association) hosted a conference on the subject of health technology assessment (HTA)-emerging countries in Ankara, Turkey on March 4–6, 2009.

Objectives: The aim of this study was to assess current evidence supporting the use of percutaneous heart valves (PHV) in degenerative aortic valve and congenital pulmonary outflow tract disease, as compared to conservative medical therapy or traditional surgical valve replacement.

Methods: A systematic review of the literature on PHV was performed.

Results: No randomized controlled trials (RCT) on PHV have been published so far. Only observational data from series and data presented at cardiology meetings are available. Both percutaneous aortic valve (PAV) and percutaneous pulmonary valve (PPV) seem feasible in the hands of an experienced team. Safety, however, seems to be a problem in PAV, as shown by the high 30-day and 6-month mortality rates.

Conclusions: Due to safety concerns, PAV reimbursement is not recommended and patients should only be subjected to PAV insertion within the boundaries of an RCT. In contrast, PPV implantation seems to be a safe and promising technology for which reimbursement under strict conditions may be recommended.

Objectives: The aim of this study was to analyze the EuroScan Database and to describe and compare the characteristics of the included technologies and participating agencies.

Methods: Data of interest were exported from the EuroScan Database to Excel and to SPSS. A descriptive analysis depending on the agency, type of technology, stage of diffusion, and technology purpose was conducted. A frequency distribution analysis of the diffusion stage for different technology types and assigned purposes was made with the EpiCalc 2000 statistical calculator. A p value of less than .05 was considered to be statistically significant.

Results: Four agencies introduced the great majority of the technologies (81 percent), with drugs representing the 46.26 percent of the total, followed by devices (21.21 percent). The purpose of 24.45 percent of the identified technologies was not specified, and 34.58 percent of them were identified at the investigational or phase III stage. The frequency distribution of diffusion stage at identification was found to be similar for devices and diagnostics (p = .543), whereas drugs were identified earlier than devices (p <.001). Some agencies were found to focus their work on drugs, whereas others focused mainly on devices. Interagency differences were also observed with regard to the stage of diffusion at which technologies were identified.

Conclusions: This is the first analysis of one of the most important databases on new and emerging health technologies. Our study suggests that more active strategies should be designed to provide an earlier identification, mainly in the case of devices.

Objectives: The aim of this study was to examine the impact of the National Institute for Health and Clinical Excellence's (NICE's) negative and restricting technology appraisals on the number of prescription items dispensed and the corresponding total net ingredient costs for drugs from 2000 to 2004 in the ambulatory care of the National Health Service (NHS) in England and Wales. In addition, it is discussed whether the NICE approach could be a role model for Germany.

Methods: The number of prescription items dispensed and the net ingredient costs of thirty-one drugs reimbursed by the NHS were analyzed, thereof thirteen drugs descriptively and twenty-one drugs with regression analyses. Data were extracted from the “Prescription-Costs-Analysis-Statistics” for the ambulatory care of the British Department of Health (England 1993–2005). In the case of the twenty-one drugs analyzed by regression analyses, predictions were established how the prescribing and the costs would have developed without NICE's drug appraisal. Finally, conclusions were drawn whether NICE's negative and restricting drug appraisals had a decreasing effect or not.

Results: For 97 percent of the drugs analyzed in this study, the publication of NICE's fourteen negative and restricting technology appraisals of drugs between 2000 and 2004 did not reduce the number of prescription items dispensed and net ingredient costs in the ambulatory care of the NHS in England and Wales.

Conclusions: Cost-effectiveness appraisals as performed by NICE or the German Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) are a useful and important tool to enhance the discussion about methods and acceptance of evidence-based medicine in general.

Background: In the debate on improving the quality and efficiency of the United States healthcare system, comparative effectiveness research is increasingly seen as a tool for reducing costs without compromising outcomes. Furthermore, the recent American Recovery and Reinvestment Act explicitly describes a prioritization function for establishing a comparative effectiveness research agenda. However, how such a function, in terms of methods and process, would go about identifying the most important priorities warranting further research has received little attention.

Objectives: This study describes an Agency for Healthcare Research and Quality-funded pilot project to translate one current comparative effectiveness review into a prioritized list of evidence gaps and research questions reflecting the views of the healthcare decision makers involved in the pilot.

Methods: To create a prioritized research agenda, we developed an interactive nominal group process that relied on a multistakeholder workgroup scoring a list of research questions on the management of coronary artery disease.

Results: According to the group, the areas of greatest uncertainty regarding the management of coronary artery disease are the comparative effectiveness of medical therapy versus percutaneous coronary interventions versus coronary artery bypass grafting for different patient subgroups; the impact of diagnostic testing; and the most effective method of developing performance measures for providers.

Conclusions: By applying our nominal group process, we were able to create a list of research priorities for healthcare decision makers. Future research should focus on refining this process because determining research priorities is essential to the success of developing an infrastructure for comparative effectiveness research.

Objectives: The aim of this study was to identify and rank the sources for the detection of potentially obsolete technologies (POTs).

Methods: A specific questionnaire related to the search strategies and sources used for the identification of POTs and also for ineffective, inefficient or harmful health technologies was sent to the Health Technology Assessment International's Information Resources Group (HTAi-IRG) group. With the obtained information and taking into account the sources used for the identification of new and emerging technologies, a second questionnaire was elaborated and sent to EuroScan and International Network of Agencies for Health Technology Assessment (INAHTA) members, who had to select and score them. For the final ranking, the number of votes and the median score were taken into account.

Results: Seven HTAi-IRG members answered to the first questionnaire. Seventeen agencies answered to the second one (thirteen EuroScan members and four more members from INAHTA), but only seven had worked in the identification of POTs and one of them using only experts for it. The remaining six agencies answered the part related to devices, diagnostics, and procedures; five of them did it for settings and programmes and only three for drugs. The Canadian Agency for Drugs and Technologies in Health (5 votes; median = 2), Cochrane Collaboration (5 votes; median = 3), NICE (4 votes; median = 1), Food and Drug Administration (4 votes; median = 1.5), and EuroScan (4 votes, median = 2) were the most relevant sources for devices and diagnostics.

Conclusions: There is little experience on POTs identification. The identified sources provide mostly indirect information and further research should take place to determine the best use of them.

Objectives: The aim of this study was to assess the trends and costs of statin use in Lithuania over a 3-year period and perform a cost-minimization and reference price analysis to rationalize the use of financial resources of the National Health Care System.

Methods: The defined daily dose (DDD) methodology was applied for assessment of statin use, which was expressed in DDD/1,000 inhabitants/day. Cost minimization and reference price calculations were used in the economic analysis.

Results: Over the 3-year period (2005–2007), the consumption and expenditures of statins in Lithuania doubled. The consumption went up from 3.87 DDD/1,000 inhabitants/day (in 2005) to 8.35 DDD/1,000 inhabitants/day (in 2007). Total expenses of statins increased during the same period from LTL6.186 million in 2005 to LTL12.418 million in 2007. Approximately 68 percent of the estimated costs for statins in 2007 were for atorvastatin. Provided that the calculated reference prices were fixed, the estimated savings would amount to a minimum of LTL1.371 million per year and could reach yearly savings in the order of LTL3.163 million. The total expenses would drop by at least 11 percent, and the decrease in costs could be as high as 25 percent (€1 = LTL3.4528).

Conclusions: Statins consumption is still very low in Lithuania in comparison with other European Union countries. Implementation of cholesterol education programs and changing reimbursement profile for statins therapy will increase consumption and expenditures. The introduction of reference-based pricing as an indirect cost control policy would help rationalizing the use of statins and their expenditures.

Objectives: Our aim was to review the recommendations given by health technology assessment (HTA) institutions in their methodological guidelines concerning the use of surrogate outcomes in their assessments. In a second step, we aimed at quantifying the role surrogate parameters take in assessment reports.

Methods: We analyzed methodological papers and guidelines from HTA agencies with International Network of Agencies for Health Technology Assessment membership as well as from institutions related to pharmaceutical regulation (i.e., reimbursement, pricing). We analyzed the use of surrogate outcomes in a sample of HTA reports randomly drawn from the HTA database. We checked methods, results (including evidence tables), and conclusions sections and extracted the outcomes reported. We report descriptive statistics on the presence of surrogate outcomes in the reports.

Results: We identified thirty-four methodological guidelines, twenty of them addressing the issue of outcome parameter choice and the problematic of surrogate outcomes. Overall HTA agencies call on caution regarding the reliance on surrogate outcomes. None of the agencies has provided a list or catalog of acceptable and validated surrogate outcomes. We extracted the outcome parameter of 140 HTA reports. Only around half of the reports determined the outcomes for the assessment prospectively. Surrogate outcomes had been used in 62 percent of the reports. However, only 3.6 percent were based upon surrogate outcomes exclusively. All of them assessed diagnostic or screening technologies and the surrogate outcomes were predominantly test characteristics.

Conclusions: HTA institutions seem to agree on a cautious approach to the use of surrogate outcomes in technology assessment. Thorough assessment of health technologies should not rely exclusively on surrogate outcomes.

Objectives: Controversy exists regarding the optimal method of providing dialysis in critically ill patients with acute renal failure. We sought to determine the cost-effectiveness of treatment strategies.

Methods: Adult subjects requiring renal replacement therapy in a critical care setting who are candidates for intermittent hemodialysis (IHD) or continuous renal replacement therapy (CRRT) were considered within a Markov model. Alternative strategies including IHD, and standard or high dose CRRT were compared. The model considered relevant clinical and economic outcomes, and incorporated data on clinical effectiveness from a recent systematic review and high quality micro-costing data.

Results: In the base-case analysis, CRRT was associated with similar health outcomes but higher costs by ($3,679 more than IHD per patient). In scenarios considering alternate cost sources, and higher intensity of IHD (including daily and longer duration IHD), CRRT remained more costly. Sensitivity analysis indicated that even small differences in the risk of mortality or need for long-term chronic dialysis therapy among surviving patients benefits led to dramatic changes in the cost-effectiveness of the modalities considered.

Conclusions: Given the higher costs of providing CRRT and absence of demonstrated benefit, IHD is the preferred modality in critically ill patients who are candidates for either IHD or CRRT, although this conclusion should be revisited if future clinical trials establish differences in clinical effectiveness between modalities. Future interventions that are proven to improve renal recovery after acute renal failure are likely to be cost-effective, even if very resource intensive.

Objective: The Israeli National Health Insurance Law stipulates a National List of Health Services (NLHS) to which all residents are entitled from their HMOs. This list has been updated annually for almost a decade using a structured review and decision-making process. Although this process has been described in detail in previous papers, none of these have fully addressed legitimacy and fairness. We examine the legitimacy and fairness of the process of updating the NLHS in Israel.

Methods: We assessed the priority-setting process for compliance with the four conditions of accountability for reasonableness outlined by Daniels and Sabin (relevance, publicity, appeals, and enforcement). These conditions emphasize transparency and stakeholder engagement in democratic deliberation.

Results: Our analysis suggests that the Israeli process for updating the NLHS does not fulfill the appeals and enforcement conditions, and only partially follows the publicity and relevance conditions, outlined in the accountability for reasonableness framework. The main obstacles for achieving these goals may relate to the large number of technologies assessed each year within a short time frame, the lack of personnel engaged in health technology assessment, and the desire for early adoption of new technologies.

Conclusions: The process of updating the NLHS in Israel is unique and not without merit. Changes in the priority-setting process should be made to increase its acceptability among the different stakeholders.

Objectives: The Weight Loss Maintenance Trial (WLM) was a multicenter, randomized trial comparing two weight loss maintenance interventions, a personal contact (PC) program with primarily telephone-based monthly contacts, and an Internet-based program (interactive technology, IT), to a self-directed control group, among overweight or obese individuals at high cardiovascular risk. This study describes implementation costs of both interventions as well as IT development costs.

Methods: Resources were micro-costed in 2006 dollars from the primary perspective of a sponsoring healthcare system considering adopting an extant intervention, rather than developing its own. Costs were discounted at 3 percent annually. Length of trial participation was 30 months (randomization during February–November 2004). IT development costs were assessed over 36 months. Univariate and multivariate, including probabilistic, sensitivity analyses were performed.

Results: Total discounted IT development costs over 36 months were $839,949 ($2,414 per IT participant). Discounted 30-month implementation costs for 342 PC participants were $537,242 ($1,571 per participant), and for 348 IT participants, were $214,879 ($617 per participant). Under all plausible scenarios, PC implementation costs exceeded IT implementation costs.

Conclusions: Costs of implementing and operating an Internet-based intervention for weight loss maintenance were substantially less than analogous costs of an intervention using standard phone and in-person contacts and are of a magnitude that would be attractive to many health systems, subject to demonstration of cost-effectiveness.

Objectives: The research objectives were two-fold: first, to systematically review the literature on the cost-effectiveness of home telehealth for chronic diseases, and second to develop a framework for the conduct of economic evaluation of home telehealth projects for patients with chronic diseases.

Methods: A comprehensive literature search identified twenty-two studies (n = 4,871 patients) on home telehealth for chronic diseases published between 1998 and 2008. Studies were reviewed in terms of their methodological quality and their conclusions.

Results: Home telehealth was found to be cost saving from the healthcare system and insurance provider perspectives in all but two studies, but the quality of the studies was generally low. An evaluative framework was developed which provides a basis to improve the quality of future studies to facilitate improved healthcare decision making, and an application of the framework is illustrated using data from an existing program evaluation of a home telehealth program.

Conclusions: Current evidence suggests that home telehealth has the potential to reduce costs, but its impact from a societal perspective remains uncertain until higher quality studies become available.

Objectives: Nuclear medicine has changed rapidly as a result of technological developments. Very little is reported on the effects these developments may have on technologist productivity. This study aims to determine whether advances have created a workplace where more patient studies can be performed with fewer technologists. The level of change in automation or time taken to perform a routine task by the nuclear medicine technologist as a result of technological development over the past decade is reported.

Methods: A systematic review was conducted using Embase.com, Medline, INSPEC, and Cinahl. Two authors reviewed each article for eligibility. Technological developments in routine areas over the past decade were reviewed. The resultant automation or time effects on data acquisition, data processing, and image processing were summarized.

Results: Sixteen articles were included in the areas of myocardial perfusion, information technology, and positron emission tomography (PET). Gamma camera design has halved the acquisition time for myocardial perfusion studies, automated analysis requires little manual intervention and information technologies and filmless departments are more efficient. Developments in PET have reduced acquisition to almost one-fifth of the time.

Conclusions: Substantial efficiencies have occurred over the decade thereby increasing productivity, but whether staffing levels are appropriate for safe, high quality practice is unclear. Future staffing adequacy is of concern given the anticipated increasing service needs.

Objectives: The aim of this study was to assess the evidence of diagnostic accuracy of the wireless capsule for endoscopy (WCE) for the diagnosis of obscure gastrointestinal bleeding (OGIB) and small bowel disease in adults and translate it to the context of the Italian National Health Service.

Methods: We performed a systematic review of secondary and primary literature. We reviewed WCE diagnostic accuracy, safety, economic evaluations for OGIB. Context-specific data about WCE diffusion, costs, appropriateness of WCE use were collected by means of a national survey involving all Italian gastroenterological departments.

Results: We updated the systematic review of the most recent health technology assessment report (2006). Our review shows lack of robust comparative evidence of diagnostic accuracy of WCE. The studies' design do not allow collection of reliable evidence due to the uncertainty surrounding morphological variability of bleeding vascular gut lesions. The national survey reported widespread WCE use and data on appropriateness and costs.

Conclusions: Evidence of WCE diagnostic accuracy is of low quality, and there is a requirement for randomized comparisons. Our findings raise the issue of technology governance and show the importance of an assessment before the technology being widely commercialized.

Objectives: The aim of this study was to obtain information on rapid health technology assessments (HTAs) prepared by members of the International Network of Agencies for Health Technology Assessment (INAHTA).

Methods: A questionnaire was prepared, drawing on earlier INAHTA documents for recording HTA impact. A request for responses was sent to member agencies, seeking information on rapid HTA reports prepared during 2006.

Results: Responses were provided on fifteen rapid HTAs, which covered both new and widely distributed technologies. The most common purpose for the HTAs (n = 8) was to inform coverage decisions, but other reasons included capital funding, formulary decisions, referral for treatment, program operation, guideline formulation, influence on routine practice, and indications for further research. All the rapid HTAs were considered by the agencies to have had some influence. The most common indications of influence were consideration by the decision maker, use of the HTA as reference material (both n = 10), and acceptance of recommendations or conclusions (n = 8).

Conclusions: Rapid HTAs are used for a broad range of technologies, to inform several types of decision, and are effective in informing the decision-making process. Supplementation of their findings by further assessments will be appropriate in some cases.

Background: In August 2002, an application for the listing on the Medicare Benefits Schedule (MBS) of PillCam® Capsule Endoscopy (formally M2A®) as a diagnostic procedure for obscure gastrointestinal bleeding (OGIB) was made to the Medical Services Advisory Committee (MSAC). As a result of this application, in May 2004 PillCam® Capsule Endoscopy was approved with interim funding until April 2007. This funding was conditional on the collection of Australian data on the long-term safety, effectiveness, and cost-effectiveness of capsule endoscopy.

Methods: A review was conducted of how the data were collected, the methodological difficulties associated with the collection and analysis of the data, and the outcomes of the data.

Results: The PillCam® Capsule Endoscopy Register ran from 2004 to 2007 and amassed data on 4,099 patients forming the largest database on PillCam® in the world. Based on these data, in November 2007, MSAC recommended that full public funding be supported under the current MBS Item Number 11820 as capsule endoscopy is as safe as and more effective than comparable diagnostic tests. It is the preferred choice of patients and has the potential to reduce the number and cost of previous investigations.

Conclusions: This form of CED proved to be ideally suited to PillCam® Capsule Endoscopy. The PillCam® Capsule Endoscopy Register provided data that made it possible to validate assumptions used in the economic modeling in the assessment carried out for MSAC in response to the application for funding.

Discussion: The use of interim funding requires both risk and cost sharing among the key players: industry, government, the medical profession, and the hospitals. Although the characteristics of PillCam® Capsule Endoscopy proved to be suited to data collection, this may not be the case with other emerging health technologies. If interim funding coupled with data collection is to become an effective mechanism for bridging the evidence gap, work needs to be carried out by health technology assessment agencies to provide guidance on the design of registers so that they cater for the unique characteristics of individual procedures.

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: The aim of this study was to determine the insulin-delivery system and the attributes of insulin therapy that best meet patients' preferences, and to estimate patients' willingness-to-pay (WTP) for them.

Methods: This was a cross-sectional discrete choice experiment (DCE) study involving 378 Canadian patients with type 1 or type 2 diabetes. Patients were asked to choose between two hypothetical insulin treatment options made up of different combinations of the attribute levels. Regression coefficients derived using conditional logit models were used to calculate patients' WTP. Stratification of the sample was performed to evaluate WTP by predefined subgroups.

Results: A total of 274 patients successfully completed the survey. Overall, patients were willing to pay the most for better blood glucose control followed by weight gain. Surprisingly, route of insulin administration was the least important attribute overall. Segmented models indicated that insulin naïve diabetics were willing to pay significantly more for both oral and inhaled short-acting insulin compared with insulin users. Surprisingly, type 1 diabetics were willing to pay $C11.53 for subcutaneous short-acting insulin, while type 2 diabetics were willing to pay $C47.23 to avoid subcutaneous short-acting insulin (p < .05). These findings support the hypothesis of a psychological barrier to initiating insulin therapy, but once that this barrier has been overcome, they accommodate and accept injectable therapy as a treatment option.

Conclusions: By understanding and addressing patients' preferences for insulin therapy, diabetes educators can use this information to find an optimal treatment approach for each individual patient, which may ultimately lead to improved control, through improved compliance, and better diabetes outcomes.

Objectives: The aim of this study is to perform a comparative costs analysis of brachytherapy (BT) and radical retropubic prostatectomy (RRP) for clinically localized prostate cancer and to shed light on the difficulties of comparing their relative economic effectiveness.

Methods: A systematic literature review of costing studies available in the Medline, Embase, DARE, and INAHTA databases.

Results: There is a lack of homogeneity among published studies in this field. Differences in the reported costs are related to different environments in which the two techniques (BT and RRP) are applied, and in particular due to the use of different methodology, cost items included, time frames, and different price levels in different settings.

Conclusion: Published studies of costing data of BT and RRP do not provide clear-cut evidence for a conclusion about which treatment may be more effective from an economic point of view.