Objectives: Enrolment into the SAMMPRIS trial published in September 2011 had to be stopped due to a 2.5 higher 30-day stroke and death rate in patients with percutaneous transluminal angioplasty and stenting (PTAS) compared with the control group with only medical therapy. After these results were published, one would have expected a change toward a clearer definition of indications for intracranial stent implantation in patients with intracranial artery stenosis, using this treatment only in patients suffering from recurrent strokes despite aggressive medical management.

Methods: The frequency of intracranial stenting and indication parameters in patients with intracranial artery stenosis were assessed from 2010 to 2013 using claims data for all inpatient episodes from Germany's largest provider of statutory health insurance.

Results: The number of intracranial stenting procedures decreased slowly from 580 in 2010 to 375 in 2013. With a rate of 29 percent there was no change between 2010 and 2013 of patients who were admitted to hospital for stent implantation, without documentation of an acute stroke or transient ischemic attack (TIA). Before PTAS, one-third of patients were admitted twice because of a stroke or TIA over a period of 5 years, 17 percent of patients had been prescribed platelet aggregation inhibitors and at least two admissions to hospital were for an ischemic cerebrovascular event before PTAS.

Conclusions: Our analysis of German claims data provides little evidence of changed indications for stenting in cases of intracranial atherosclerotic disease which one might expect to be caused by the emergence of high-level evidence.

Objectives: The aim of this study was to describe the healthcare system and health financing in Bosnia and Herzegovina and recent trends in health technology assessment (HTA) placement in the system.

Methods: A short review of PubMed published literature has been conducted using key words related to reimbursement, HTA, and health policy. We also revised legislation in Bosnia and Herzegovina published in Official Gazettes related to healthcare financing and organization.

Results: A deecentralized system in Bosnia and Herzegovina led to high differences in health policy. HTA has been recognized in legislation in Bosnia and Herzegovina, but it still has not been introduced in practice in full capacity. A small number of publications are found in PubMed treating these issues, but generally the problem of introduction of HTA in Bosnia and Herzegovina is lack of experts, as well as the political environment and education in this field.

Conclusions: HTA in the Federation of Bosnia and Herzegovina and the Republic of Srpska has a short history because of a huge political impact in the decision-making process, decentralized system, and multiple decision makers in these regions. Challenges remain in assessments, in development of more transparent approaches in different areas of the health system in these regions, and in consistent application of appropriate standards especially in education of professionals who will provide establishment of HTA in the health system of The Federation of Bosnia and Herzegovina and the Republic of Srpska.

Background: Defining relevant outcome measures for clinical trials on medical devices (MD) is complex, as there is a large variety of potentially relevant outcomes. The chosen outcomes vary widely across clinical trials making the assessment in evidence syntheses very challenging. The objective is to provide an overview on the current common procedures of health technology assessment (HTA) institutions in defining outcome measures in MD trials.

Methods: In 2012–14, the Web pages of 126 institutions involved in HTA were searched for methodological manuals written in English or German that describe methods for the predefinition process of outcome measures. Additionally, the institutions were contacted by email. Relevant information was extracted. All process steps were performed independently by two reviewers.

Results: Twenty-four manuals and ten responses from the email request were included in the analysis. Overall, 88.5 percent of the institutions describe the type of outcomes that should be considered in detail and 84.6 percent agree that the main focus should be on patient relevant outcomes. Specifically related to MD, information could be obtained in 26 percent of the included manuals and email responses. Eleven percent of the institutions report a particular consideration of MD related outcomes.

Conclusions: This detailed analysis on common procedures of HTA institutions in the context of defining relevant outcome measures for the assessment of MD shows that standardized procedures for MD from the perspective of HTA institutions are not widespread. This leads to the question if a homogenous approach should be implemented in the field of HTA on MD.

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: The Priorities and Evaluation Committee (PEC) funding recommendations for new cancer drugs in British Columbia, Canada have been based on both clinical and economic evidence. The British Columbia Ministry of Health makes funding decisions. We assessed the association between cost-effectiveness of cancer drugs considered from 1998 to 2008 and the subsequent funding decisions.

Methods: All proposals submitted to the PEC between 1998 and 2008 were reviewed, and the association between cost-effectiveness and funding decisions was examined by (i) using logistic regression to test the hypothesis that interventions with higher incremental cost-effectiveness ratios (ICERs) have a lower probability of receiving a positive funding decision and (ii) using parametric and nonparametric tests to determine if a statistically significant difference exists between the mean cost-effectiveness of funded versus not funded proposals. A sub-analysis was conducted to determine if the findings varied across different outcome measures.

Results: Of the 149 proposals reviewed, 78 reported cost-effectiveness using various outcome measures. In the proposals that used life-years gained as the outcome (n = 22), a statistically significant difference of nearly $115,000 was observed between the mean ICERs for funded proposals ($42,006) and for unfunded proposals ($156,967). An odds ratio indicating higher ICERs have a lower probability of being funded was also found to be statistically significant (p < .05).

Conclusions: Economic evidence appears to play a role in British Columbia cancer funding decisions from 1998 to 2008; other decision-making criteria may also have an important role in recommendations and subsequent funding decisions.

Objectives: Hospital-based health technology assessment (HTA) has become increasingly important in Brazil due to its strategic importance to promote adoption, incorporation, dissemination, and disinvestment of technologies. A strategy to foster hospital-based HTA was implemented in 2009 by creating hospital-based HTA nuclei (NATS) at university hospitals and other strategic hospitals.

Methods: Between 2011 and 2012, we interviewed board members in twenty-three NATS located in all geographic regions of Brazil to assess their general characteristics, scientific output, and challenges.

Results: Of the total, 65 percent of the NATS belonged to teaching institutions, with 44 percent associated with federal universities. The bulk of their output was in the form of mini-HTA reports. Centers in the Southeast and South of Brazil had the highest production compared with other regions. Lack of expertise and low levels of advanced training were identified as limiting factors in the majority of centers.

Conclusions: The experience of the initial twenty-three NATS could be considered positive and has led to the creation of new ones around Brazil. Regional disparities in workload, production, and technical training should be targeted by new policies toward hospital-based HTA in Brazil. The limits and possibilities for intensifying the strategy relate to continuous investment in priority studies, which simultaneously, allow professionals who work in hospitals to receive continued education and produce relevant HTA work in a timely manner.

Objectives: The aim of this study was to describe the current regulatory environment in Greece to evaluate the potential introduction of health technology assessment (HTA) for medicinal products for human use.

Methods: Data sources consist of national legislation on pricing and reimbursement of health technologies to identify the potential need of establishing HTA and its relevant structure.

Results: The pricing procedure regarding medicinal products for human use is based on an external reference pricing mechanism which considers the average of the three lowest Euorpean Union prices. Currently, a formal HTA procedure has not been applied in Greece, and the only prerequisite used for the reimbursement of medicinal products for human use is their inclusion in the Positive Reimbursement List. To restrict pharmaceutical expenditure, a variety of measures—such as clawback mechanisms, rebates, monthly budget caps per physician, generics penetration targeting—have been imposed, aiming mainly to regulate the price level rather than control the introduction of medicinal products for human use in the Greek pharmaceutical market.

Conclusions: Greece has the opportunity to rapidly build capacity, implement, and take advantage of the application of HTA mechanisms by clearly defining the goals, scope, systems, context, stakeholders, and methods that will be involved in the local HTA processes, taking into account the country's established e-prescription system and the recently adapted legislative framework.

Objectives: To compare the recently used phacoemulsification systems using a health technology assessment (HTA) model.

Methods: A self-administered questionnaire, which included questions to gauge on the opinions of the recently used phacoemulsification systems, was distributed to the chief cataract surgeons in the departments of ophthalmology of eighteen tertiary hospitals in Shanghai, China. A series of senile cataract patients undergoing phacoemulsification surgery were enrolled in the study. The surgical results and the average costs related to their surgeries were all recorded and compared for the recently used phacoemulsification systems.

Results: The four phacoemulsification systems currently used in Shanghai are the Infiniti Vision, Centurion Vision, WhiteStar Signature, and Stellaris Vision Enhancement systems. All of the doctors confirmed that the systems they used would help cataract patients recover vision. A total of 150 cataract patients who underwent phacoemulsification surgery were enrolled in the present study. A significant difference was found among the four groups in cumulative dissipated energy, with the lowest value found in the Centurion group. No serious complications were observed and a positive trend in visual acuity was found in all four groups after cataract surgery. The highest total cost of surgery was associated with procedures conducted using the Centurion Vision system, and significant differences between systems were mainly because of the cost of the consumables used in the different surgeries.

Conclusions: This HTA comparison of four recently used phacoemulsification systems found that each of system offers a satisfactory vision recovery outcome, but differs in surgical efficacy and costs.

Objectives: Technological development and the need for electronic health records management resulted in the need for a computer with dedicated, commercial software in daily dental practice. The alternative for commercial software may be open-source solutions. Therefore, this study reviewed the current literature on the availability and use of open-source software (OSS) in dentistry.

Methods: A comprehensive database search was performed on February 1, 2017. Only articles published in peer-reviewed journals with a focus on the use or description of OSS were retrieved. The level of evidence, according to Oxford EBM Centre Levels of Evidence Scale was classified for all studies. Experimental studies underwent additional quality reporting assessment.

Results: The screening and evaluation process resulted in twenty-one studies from 1,940 articles found, with 10 of them being experimental studies. None of the articles provided level 1 evidence, and only one study was considered high quality following quality assessment.

Twenty-six different OSS programs were described in the included studies of which ten were used for image visualization, five were used for healthcare records management, four were used for educations processes, one was used for remote consultation and simulation, and six were used for general purposes.

Conclusions: Our analysis revealed that the dental literature on OSS consists of scarce, incomplete, and methodologically low quality information.

Background: The aim of this study was to assess the quality of reporting sample size calculation and underlying design assumptions in pivotal trials of high-risk medical devices (MDs) for neurological conditions.

Methods: Systematic review of research protocols for publicly registered randomized controlled trials (RCTs). In the absence of a published protocol, principal investigators were contacted for additional data. To be included, trials had to investigate a high-risk MD, registered between 2005 and 2015, with indications stroke, headache disorders, and epilepsy as case samples within central nervous system diseases. Extraction of key methodological parameters for sample size calculation was performed independently and peer-reviewed.

Results: In a final sample of seventy-one eligible trials, we collected data from thirty-one trials. Eighteen protocols were obtained from the public domain or principal investigators. Data availability decreased during the extraction process, with almost all data available for stroke-related trials. Of the thirty-one trials with sample size information available, twenty-six reported a predefined calculation and underlying assumptions. Justification was given in twenty and evidence for parameter estimation in sixteen trials. Estimates were most often based on previous research, including RCTs and observational data. Observational data were predominantly represented by retrospective designs. Other references for parameter estimation indicated a lower level of evidence.

Conclusions: Our systematic review of trials on high-risk MDs confirms previous research, which has documented deficiencies regarding data availability and a lack of reporting on sample size calculation. More effort is needed to ensure both relevant sources, that is, original research protocols, to be publicly available and reporting requirements to be standardized.

Objectives: The healthcare transformation program in Turkey has shown its success with improvements in important health indicators, increased access to healthcare services and expansion of coverage to all citizens. Turkey has been relatively able to bear the burdens associated with this due to rapid economic growth. The need for health technology assessment (HTA) was believed as a result of the expansion of coverage, pressure of new technologies, and increased expenditures. This study outlines the background and current formalization of HTA and shares the current use of HTA in decision making, while summarizing the transformation of the Turkish healthcare system for developing a high-quality, equal, and accessible care system.

Methods: We reviewed and analyzed policy changes in the Turkish healthcare system, universal health coverage, healthcare expenditures, and pricing and reimbursement policies to identify the changes leading to HTA. We reviewed existing HTA functions in Turkey and outlined their activities. Finally, we outlined a set of major challenges for HTA in Turkey over the next decade.

Results: HTA was formalized in Turkey in 2012–2013 with three national HTA structures and one hospital-based HTA unit. These functions currently run independent from each other. There are three major challenges in this country for HTA in the next decade: clarification of the assessment scope and methods, building a strong supporting system for HTA, and defining the role of HTA in the future vision of Turkish healthcare policy.

Conclusion: HTA, despite challenges, has a good opportunity to develop further with clear action plans and strong political will.

Objectives: The aim of this study was to adapt and assess the value of a Multi-Criteria Decision Analysis (MCDA) framework (EVIDEM) for the evaluation of Orphan drugs in Catalonia (Catalan Health Service).

Methods: The standard evaluation and decision-making procedures of CatSalut were compared with the EVIDEM methodology and contents. The EVIDEM framework was adapted to the Catalan context, focusing on the evaluation of Orphan drugs (PASFTAC program), during a Workshop with sixteen PASFTAC members. The criteria weighting was done using two different techniques (nonhierarchical and hierarchical). Reliability was assessed by re-test.

Results: The EVIDEM framework and methodology was found useful and feasible for Orphan drugs evaluation and decision making in Catalonia. All the criteria considered for the development of the CatSalut Technical Reports and decision making were considered in the framework. Nevertheless, the framework could improve the reporting of some of these criteria (i.e., “unmet needs” or “nonmedical costs”). Some Contextual criteria were removed (i.e., “Mandate and scope of healthcare system”, “Environmental impact”) or adapted (“population priorities and access”) for CatSalut purposes. Independently of the weighting technique considered, the most important evaluation criteria identified for orphan drugs were: “disease severity”, “unmet needs” and “comparative effectiveness”, while the “size of the population” had the lowest relevance for decision making. Test–retest analysis showed weight consistency among techniques, supporting reliability overtime.

Conclusions: MCDA (EVIDEM framework) could be a useful tool to complement the current evaluation methods of CatSalut, contributing to standardization and pragmatism, providing a method to tackle ethical dilemmas and facilitating discussions related to decision making.