Over the past decades, early awareness and alert (EAA) activities and systems have gained importance and become a key early Health Technology Assessment (HTA) tool. While a pioneer in HTA, Sweden had no national level EAA activities until recently. We describe the evolution and current status of the Swedish EAA System.

This was a historical analysis based on the knowledge and experience of the authors supplemented by a targeted review of published and grey literature, as well as documents produced by or relating to the Swedish EAA System. Key milestones and a description of the current state of the Swedish EAA System are presented.

Initiatives to establish a system for the identification and assessment of emerging health technologies in Sweden date back to the 1980s. Since the 1990s, the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) supported the development of EuroScan and was one of its founding members. In the mid-2000s, an independent regional initiative, driven by the Stockholm Drug and Therapeutics Committee, resulted in the establishment of a regional horizon scanning unit. By 2009, this work had expanded to a collaboration between the four biggest regions in Sweden. The following year it was further expanded to the national level. Today, the Swedish EAA System carries out identification, filtration and prioritization of new drugs, early assessment of the prioritized drugs, and dissemination of the information. Its outputs are used to select new drugs for inclusion in the Swedish national process for managed introduction and follow-up.

The Swedish EAA System started as a regional initiative and rapidly grew to become a national level activity. An important feature of the system today is its complete integration into the national process for managed introduction and follow-up of new drugs. The system will continue to evolve as a response both to the changing landscape of health innovations and to new policy initiatives at the regional, national and international levels.

The telediagnostic systems can achieve relevant epidemiological information from local community needs to global countrywide opportunities. In this context the telemedicine applications should be directed to gain the prevalence of pathologies towards developing better equity in the provision of services (1), and greater concern for the effectiveness and usefulness of health technologies in remote locations without access to specialists (2). This study, has evaluated the results of a telemedicine system in remote public regional and district hospitals in Paraguay (3), in order to show the epidemiological trends in communities of a low income country.

This prospective study used the results of telemedicine for diagnosis in remote regional and district hospitals to evaluate a as tool to determine the prevalence of pathologies countrywide over three years (2014-16). For these purposes, type and frequency of pathology diagnosed was determined. Sampling was non-probabilistic of convenience.

A total of 182,406 telediagnoses were performed in 54 hospitals. The electrocardiography (ECG) diagnosis performed in the 52 hospitals were normal (62.1 percent), unspecified arrhythmias (12.5 percent), sinus bradycardia (10.4 percent), left ventricular hypertrophy (4.1 percent), sinus tachycardia (4.4 percent), right bundle branch block (3.5 percent), ischemia (1.4 percent), atrial fibrillation (1.0 percent) and left bundle branch block (0.6 percent). Teletomography was performed in twelve hospitals, where 54.4 percent corresponded to skull as a consequence of accidents (motorcycles) and cerebrovascular diseases, 13.8 percent chest, 6.2 percent dorsal spine, 5.4 percent abdominal and the rest the other anatomical regions. Regarding electroencephalography (EEG), antecedents of seizure (54.3 percent), evolutionary control (14.0 percent), headache (11.5 percent), cognitive impairment (2.0 percent), attention deficit in children (learning) (2.0 percent), brain death (1.0 percent), abnormal movements (0.8 percent), and sleep disturbances (0.3 percent) were diagnosed. The nineteen ultrasound studies corresponded to prenatal controls.

Despite the results of the telediagnosis implemented in the public health system to determine the prevalence of pathologies countrywide, a widespread use-assessment should be analyzed before deciding a large diffusion as a tool for public health planning.

As of July 2016, funding from England's Cancer Drugs Fund (CDF) is dispensed based on the results of National Institute for Health and Care Excellence (NICE) technology appraisal guidances instead of independent CDF appraisals (1). NICE can recommend providing temporary CDF funding for drugs that have potential to demonstrate cost-effectiveness after further data collection (2). This analysis examines drugs considered for temporary CDF funding since the start of this new process in July 2016.

We collected all final NICE oncology technology appraisal guidances completed before the end of 2016 and noted whether each drug was considered for or awarded CDF funding and which factors impacted the decision to give or withhold CDF funding (3).

We identified twenty-one NICE oncology reviews completed between July 2016 and the end of 2016. Of these reviews, only one was recommended for temporary funding under the CDF because further data collection had the potential to significantly reduce incremental cost-effectiveness ratios (ICERs). Three further reviews were considered for temporary CDF funding but ultimately received negative decisions. In all three cases, NICE found no potential for further data collection to sufficiently improve ICERs. The evaluations also noted that the manufacturers either did not intend or did not have sufficient time to prepare a case for CDF funding.

NICE focused strongly on evidence maturity in making CDF funding decisions. The only drug recommended for CDF funding had immature trial data with uncertainties that could be resolved by further data collection. The three drugs that did not receive CDF funding had relatively mature evidence that would not be improved through further data collection. Timing was also an issue: two reviews specifically noted that the manufacturers had insufficient time to prepare strong cases for CDF funding. The CDF historically had significant budget issues, so NICE may be trying to be more judicious in allocating CDF funding.

The Spanish National Network (REDETS) is a group of eight agencies, units and services, depending on National and Regional Governments that coordinate their work within a common methodological framework, guided by the principles of mutual recognition and cooperation. The necessity of considering a Quality Management System has been detected and, consequently, a common tool for all the members needs to be developed. We describe in this study the process to achieve that goal.

Based on both a review of previous literature and the proposal for a self-evaluating tool, a group of experts from each agency through consensus have developed a tool for self-evaluation in Health Technology Assessment (HTA) agencies. Through the structure described in the handbook of the Andalusian Agency for Healthcare Quality (ACSA), each standard should have a statement or proposal that needs to also include evidence or good practices, and the corresponding evaluation questions. In separate workgroups, the definition of these proposals, evidence and evaluation questions were developed. One face-to-face meeting and two meetings via teleconference were necessary to achieve a final document with all the quality standards.

From a proposed structure of sixty-six standards, the titles, definitions, statements and evidence as well as good practices and evaluation questions were established in workgroups with consensus among all of the members (1 - 3). The final version of the self-assessment tool was composed of sixty-eight standards, grouped in twelve quality criteria structured in four dimensions: I Responsibility, II Clients and Stakeholders, III Production Process, and IV Resources.

Quality management requires an evaluation tool and this version, based on a systematic review and consensus, is a useful and practical instrument for developing a handbook by each member of REDETS. An online version of the tool is in process of development.

The socioeconomic burden of diseases is increasing in Africa. For instance in 2011, 70 percent of the world's human immunodeficiency virus (HIV) population resided in sub-Sahara Africa. There are also growing rates of Antimicrobial Resistance (AMR), which necessitates newer more expensive antibiotics adding to costs. There is also a growing burden of non-communicable diseases (NCDs), three out of four patients with hypertension currently live in low and middle income countries (LMICs), with prevalence rates up to 30 to 45 percent among adults in Africa. Alongside this, up to 70 percent of total healthcare expenditure is spent on medicines in LMICs; much of this out-of-pocket. Consequently, there is an urgent need to strengthen collaborative research to improve medicine use.

Summary of groups working together in Africa including the Medicines Utilisation Research in Africa (MURIA) group.

African Strategies for Health identifies and advocates best practices, as well as works with others to develop sustainable solutions. Pharmacology for Africa (PharfA) organises and promotes pharmacology on the African continent, including research in clinical pharmacology, alongside the International Union of Basic and Clinical Pharmacology (IUPHAR) sub-division. International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Africa co-ordinates activities from the different African country chapters. The South African Health Technology Assessment Society (SAHTAS) is a scientific and professional society for all those who produce, use, or encounter Health Technology Assessment (HTA) in Southern Africa, and the World Health Organization (WHO) International and Regional groups are improving antibiotic drug utilization capabilities in Africa. The MURIA group was established in 2015 (1). Ongoing collaborative research includes (i) initiatives to optimize antibiotic use; (ii) methods to enhance adherence to anti-infective prescribing guidance, (iii) approaches to improve adherence to HIV and NCDs; (iv) researching current anti-hypertensive utilization patterns and knowledge; (v) approaches to enhance Drugs and Therapeutic Committees (DTC) activities, and (vi) strengthening medicine utilization capabilities (2,3). These activities have already strengthened research ties across Africa.

A number of groups are already working across Africa to enhance appropriate medicine use, and should continue. Ongoing MURIA activities include antibiotic point-prevalence studies, ongoing research into infectious diseases, NCDs and DTCs including adherence as well as the third workshop and symposium in Namibia in 2017.

We aimed to identify the validity and robustness of effect estimates for serious rare adverse events in clinical study reports of antidepressant trials, across different meta-analysis methods for rare binary events data (1,2).

Four serious rare adverse events (all-cause mortality, suicidality, aggressive behaviour and akathisia) were meta-analyzed using different methods (3). The Yusuf-Peto odds ratio (OR), which ignores studies with no events in the treatment arms, was compared with the alternative approaches of generalized linear mixed models (GLMM), conditional logistic regression, a Bayesian approach using Markov Chain Monte Carlo (MCMC) and a beta-binomial regression model.

Though the estimates for the four outcomes did not change substantially across the different analysis methods, the Yusuf-Peto method underestimated the treatment harm and overstimated its precision, especially when the estimated odds ratio (OR) deviated greatly from 1. For example the OR for suicidality for children and adolescents was 2.39 (95 percent Confidence Interval, CI 1.32 to 4.33, using the Yusuf-Peto method), but increased to 2.64 (95 percent CI 1.33 to 5.26) using conditional logistic regression, to 2.69 (95 percent CI 1.19 to 6.09) using beta-binomial, to 2.73 (95 percent CI 1.37 to 5.42) using the GLMM and finally to 2.87 (95 percent CI 1.42 to 5.98) using the MCMC approach.

The method used for meta-analysis of rare events data influences the estimates obtained and the exclusion of double zero-event studies can give misleading results. To ensure reduction of bias and erroneous inferences, sensitivity analyses should be performed using different methods and we recommend that the Yusuf-Peto approach should no longer be used. Other methods, in particular the beta-binomial method that was shown to be superior, should be considered instead.

The aim of the study was to introduce ethnographic fieldwork (1), including participant-observation and ethnographic interviews. Ethnographic fieldwork is a robust research methodology to study patients experiences and perspectives and, therefore, particularly valuable for Health Technology Assessment (HTA). Conducting ethnographic fieldwork requires that the researcher joins the people under study where they live or work for a period of time to observe and experience their everyday life and grasp their point of view in relation to the assessment of a health technology.

The presentation focuses on ethnographic fieldwork with participant-observation and ethnographic interviews. In relation to HTA, fieldwork can be highly relevant in order to understand the social world of the patients, for instance how they perceive and act in relation to a health technology. Furthermore fieldnotes, considerations on the analytic process and the production of knowledge will be a focus in the presentation.

We argue, that a small fieldwork study based on participant-observation can do much more than just act as supplements to differents forms of interviews. We demonstrate that in the production of an HTA, patient knowledge should not depend on or prioritize one method like interviews or recorded talks. We show the importance of good fieldnotes in the process of analysis together with a discussion of the production of knowledge.

To explore patients perspectives is thus not to identify one ’true’ perspective through an individual interview. Patients perspectives and experiences are emerging, relational and shifting. Therefore, there is a need for enhancing methodological and epistemological reflections and discussions about future development of ethnographic fieldwork in relation to HTA and patient involvement. The potential use of ethnographic fieldwork including participant-observation and ethnographic interviews will be highly relevant in relation to the assessment of new screening procedures, tele-health solutions, and collaboration between different sectors such as hospitals, municipalities and general practice. Furthermore, ethnographic fieldwork would be of importance for exploring how technology is working in local settings.

Organizational aspects influence the behavior of healthcare professionals and managers, and may help to overcome the barriers in the implementation of new health technologies. However, the organizational domain is often under-represented or absent when Health Technology Assessment (HTA) reports are built. The objective of this study was to to explore the organizational assessment in HTA and build a new framework for applicative experience after the comparison with the European Network for HTA (EUnetHTA's) CoreModel 3.0.

A literature review was performed by extracting full HTA reports through INAHTA (International Network of Agencies for Health Technology Assessment) members websites, HTA agencies and snowball search, and the aspects relating to the organizational assessment were analyzed. A quantitative and qualitative analysis was performed on the retrieved reports and the results were compared with a framework of five domains and fifteen subdomains from EUnetHTA's CoreModel 3.0. A Multiple Correspondence Analysis was carried out in order to evaluate the power of CoreModel and identify new common domains to guide the organizational assessments in HTA reports.

The assessments of organizational issues in the reports were significantly heterogeneous and less common than inclusion of other classic assessments. When included, domains and subdomains of the CoreModel were not covered homogeneously by the organizational assessments (representation level varied from 19 percent to 62 percent). The statistical analysis performed on the current data and the subsequent clustering of items offered the possibility to develop a new methodology based on three new composite indicators.

This ongoing study analyzed the relevance of organizational assessments in current literature and the challenges of promoting an international approach to the matter. In this sense, according to the current state of the research, we proposed a new methodology to cover the most relevant aspects of organizational appraisal according to new, more homogeneous domains and a less context-oriented approach to encourage health professionals to perform organizational analysis and better fulfill the needs of future HTA research.

As part of the European Network for Health Technology Assessment (EUnetHTA) Joint Action 3, the National Institute for Health and Care Excellence (NICE) in collaboration with forty-nine Health Technology Assessment (HTA) agencies and payer organizations, is leading on research to gain a high level understanding of HTA processes across Europe. This will help to facilitate improved collaboration and use of EUnetHTA HTA reports and tools across member states and decrease the duplication of work.

To analyze the similarities and differences in HTA processes and decision making on the reimbursement of pharmaceuticals and medical devices across Europe.

National agencies involved in the HTA and reimbursement processes shared data on HTA and decision-making processes. Data provided was extracted into an excel workbook including information relating to pharmaceuticals, medical devices, inpatient and outpatient care and assessments that inform reimbursement, pricing and other processes.

Thirty-one countries provided fifty-eight sets of HTA process and procedural documents for both medical devices and pharmaceuticals. This information was translated into the workbook which consisted of eleven sections (general information, capacity, overview of the process, topic selection, assessment process, advice and decision making, legal and procedural issues, reassessment, stakeholders engagement, HTA information used and HTA information held).

The first stage of data analysis is a descriptive write up of existing processes from horizon scanning and topic selection up to decision making. The second stage is an analysis showing how collaboration and use of EUnetHTA outputs can be implemented into existing processes. An additional questionnaire will be developed to gain further understanding of EUnetHTA partners views on national engagement in the EUnetHTA procedures, implications of joint production, what EUnetHTA products are most valued and what mechanism might support better information sharing and more efficient use of HTA reports between jurisdictions.

The analysis of the above data will provide detailed information on how EUnetHTA products or HTA products from other jurisdictions could be introduced into HTA and reimbursement processes across member states and at what point could EUnetHTA partners best engage in joint and cooperative work.

Evaluation is crucial for integration of e-Health/m-Health applications into healthcare systems and their further sustainability. However, evaluation of these technologies is often challenged by poor quality of research design, lack of common outcome indicators and no consensus on appropriate methodology. Health Technology Assessment (HTA) could offer a sound methodological basis for these evaluations (1). The aim of this study was to look for HTA reports on e-Health/m-Health technologies and to describe their characteristics and analyze transparency, consistency and thoroughness, with the goal to detect fields for improvements.

A literature search was performed on PubMed, ISI WOS and University of York – Centre for Reviews and Dissemination (CRD) electronic databases, in order to identify reports that had evaluated e-Health/m-Health technologies, published until 1 April 2016. We used the International Network of Agencies for Health Technology Assessment (INAHTA) checklist (2) to evaluate transparency and consistency of included reports. We also assessed thoroughness of reports by checking the presence of the domains suggested by European Network for HTA (EUnetHTA) HTA Core Model (3).

Twenty-eight reports published between 1999 and 2015 were included. Most of reports (71.4 percent) were delivered by non-European countries and only 35.7 percent were classified as full reports. E-Health/m-Health technologies from several fields of medicine, mostly cardiology (21.4 percent) and psychiatry (17.9 percent) were evaluated. Policy question was clearly defined in 32.1 percent of reports, whereas ethical (21.4 percent) and legal implications (3.6 percent) were domains with the least presence. With respect to the EUnetHTA Core Model, around 70 percent of reports dealt with effectiveness and economic evaluation, more than 50 percent described health problem and around 40 percent organizational and social aspects. Remaining domains were evaluated in very few reports.

E-Health/m-Health technologies are increasingly present in the field of HTA. Our work identified a number of elements not being included in the available reports. Several reports missed to respond to relevant assessment elements especially ethical, social and organizational implications. There is a need for strengthening and standardizing methods used for the evaluation of these technologies.

Early awareness and alert systems (EAAS) try to anticipate the impact of new technologies in the healthcare systems. Spain, which has a decentralized health system with public provision and universal health coverage, has been a pioneer in establishing EAAS activities. From 2006 a network of regional agencies coordinated EAAS activities. Taking into account the individual agencies scarce resources and in order to improve efficiency, this collaboration decided to distribute tasks when identifying and early assessment of new and emerging health technologies. The aim was to inform the common benefit package of the Spanish public health system.

Four out of eight Spanish Health Technology Assessment (HTA) agencies had EAAS in Spain (AETS-Carlos III Institute; AETSA-Andalusia; Avalia-t-Galicia; Osteba-Basque Country). Each agency has taken care of different sources for the identification of new and emerging non-drug health technologies: industry and innovator contacts, health expert networks, mass media and EAAS databases. Members of the network used the same filtration criteria to reach the final list. The system will run in parallel to a biannual identification process in major databases.

In 2016, the network identified and filtered sixty-three technologies: ten by mass media; five by health experts; thirty-five other EAAS and thirteen by direct contact with industry and innovators. Main represented specialties were: endocrinology (seven); gynecology and obstetrics (six); cardiology and cardiac surgery (five); emergency medicine (four); dermatology (three) and pneumology (three). Technologies were grouped by specialty in order to inform the different commissions that discuss inclusion in the Spanish Benefit Package. Specialty monographs will be published to inform stakeholders.

The approach is feasible, and increases the capacity of individual agencies to address the needs of the national and regional systems by improving their efficiency. There is a need to previously define the methods and the criteria that will be used for the identification and filtration.

The method appraises the stakeholders value judgments in the Health Technology Assessment (HTA) process, through a new model of research that addresses clinical scenarios to simulate real world HTA dilemmas and support decision making. The scenarios are based on criteria, such as clinical and epidemiological elements, and also, economic, social and ethical factors. The stakeholders decisions can induce strategic impacts in different HTA fields. We agreed to call this model Decision Making Clinical Scenarios (DMCS).

The model of research is based on a cross exploratory research, through a DMCS questionnaire applied to stakeholder respondents. The first survey was composed of four scenarios. The scenarios introduce value judgments, preferences and structuring choices, under specific circumstances. The scenarios are based on trade-offs involving HTA, such as budget impact, sources of funding, patients eligibility, technology characteristics and disease epidemiology. The stakeholders points of view are analyzed, through groups that represent payers, suppliers, developers, researchers, prescribers, regulators, government, patients and society.

The scenarios have been shown to be understandable for all stakeholders groups. When testing the model with hypothetical dilemmas through clinical scenarios, the results are strongly influenced by each presented trade-off. We can observe specific trends and motivations when analyzing the stakeholders groups separately. The results are always evaluated and validated through statistical analysis. A total of 193 stakeholders answered the survey. The majority were male (n = 104; 53.9 percent) and aged between 31 and 40 years (n = 71; 36.8 percent). In scenario 1, almost half of respondents (n = 95; 49.2 percent opted not to incorporate the new drug and in scenario 2, an even higher proportion chose not to incorporate the new drug (n = 112; 58.0 percent). In scenario 3, most have responded to not incorporate the new treatment for any age group (n = 81; 42.0 percent). In scenario 4, 65 percent of respondents opted for the preferential allocation for prevention, rather than treatment (n = 125; 64.8 percent). Overall results showed a conservative trend, considering the presented criteria and trade-offs.

We concluded that most stakeholders are not guided only by the clinical benefit of a decision. They valorize the importance of funding mechanisms and budget control, and consider economic, social, ethical, clinical and epidemiological aspects. This study model seems to be useful to evaluate the trends of decision makers conduct. We understand that the use of clinical scenarios brings the discussion into the enviroment and dynamics of the HTA process, where outcome impacts can be analyzed properly. This model can be explored in further research, using flexible criteria for each desired scenario, through real world situations. This model can be used to evaluate impacts in strategic subjects, as budget allocation, public healthcare policies, and patient-shared decision making.

Influenza is a disease related to the human respiratory system, with economic and social burden a common cause of Influenza-Like-Illness (ILI) among children and the elderly. This study was conducted to estimate cost of illness based on social perspectives of ILI cases.

A prospective study was conducted between February and March 2016 in pharmacies and private clinics at Khanh Hoa, Lam Dong, Tay Ninh, Dong Nai province, Ho Chi Minh City and Hospital of Tropical Diseases. Demographic and clinical information was collected by face-to-face interview. Treatment costs included direct costs (for example, diagnosis, therapeutics) and indirect cost (cost of days lost).

Average costs associated with the ILI were USD88.09 per case among all age groups, direct non-medical costs were more dominant than direct medical costs accounting for 39.5 percent in pharmacies, 71.1 percent in clinics and 64.2 percent in hospitals. Total average cost was estimated to be EUR105 in children, and EUR514 in adults in Germany (1); and in South China, direct medical cost of ILI would be USD22.69 (2).

The cost of ILI was the reason for the economic burden of patients and their families. This study provides the data for the future research, programs and policies which can be applied for influenza or ILI in Vietnam.

Due to the rising costs caused by an increasing demand for Sexually Transmitted Infection (STI) care, the Dutch government changed the funding of STI-clinics (1). A more restrictive testing policy introduced in 2015 no longer required syphilis and human immunodeficiency virus (HIV) tests for younger, heterosexual clients. A less extensive testing policy could be detrimental to the aim of finding and treating STIs (2,3). Infections that remain undetected could possibly lead to an increase in both the total and individual burden of disease, due to transmission and the need for more intensive treatment resulting in higher healthcare costs in the long term. In this study, we evaluated the new Dutch testing policy with respect to intended savings and missed syphilis and/or HIV infections. Moreover, we explored the efficiency of alternative test policies.

Using national surveillance data from 2011 to 2013 with still comprehensive testing for all, we estimated the effects of restrictive testing on test costs, number of infections missed, costs per missed infection, costs per Quality Adjusted Life Year (QALY) lost, and calculated the net monetary benefit.

The 2015-policy led to estimated savings of EUR1.1 million, while missing approximately three of ten HIV infections and seven of twenty syphilis infections among all younger heterosexual clients (in total 143,612 consultations) per year. Savings were EUR435,000 per QALY lost. Standard testing second-generation immigrants for syphilis and HIV saved EUR525,000/QALY lost. Offering an HIV test when diagnosed with chlamydia or gonorrhoea resulted in savings of EUR568,000/ QALY lost.

The 2015-testing policy resulted in substantial savings as few missed HIV and syphilis infections caused QALY losses. Additional standard syphilis and HIV tests for second-generation immigrants and an additional HIV test in case of positive chlamydia or gonorrhoea diagnosis could reduce missed infections in a cost-effective way.

The analysis of cell-free fetal DNA in maternal blood, also called Non-Invasive Prenatal Testing (NIPT), represents an emerging technology and a possible alternative/complement to current prenatal screening based on biochemical and sonographic markers for Down Syndrome (DS) detection.

The aim of the study was to compare the application of NIPT with the prenatal diagnosis/screening procedures currently applied in the Basque Country.

An analytical decision model was developed to assess the costs and consequences, comparing current prenatal screening, NIPT as a contingency test in high-risk cases and NIPT as a first-line screening test. An economic analysis was conducted to determine which strategy was more cost-effective. Sensitivity analyses were performed (1).

For a population of 97,074 pregnant women in gestational week 14 and a cut-off point of 1:270, NIPT as a contingent test was not cost-effective, detecting two cases less of DS and causing a lower number of miscarriages related to invasive-testing (4 versus 23) at a slightly lower cost (EUR8,111,351 versus EUR8,901,872).

For risk cut-off points of 1:500 or 1:1000 for contingent NIPT, the number of DS cases detected increased, as did the cost. It could be cost-effective compared with current prenatal screening, (EUR61,763 or EUR256,123 per extra DS case detected, respectively).

Using the NIPT as a primary test detected more DS cases (296 versus 271) and caused less miscarriages (5 versus 23), at a substantially higher cost (EUR41,395,645 versus EUR8,901,872). Cost-effectiveness analysis indicated that it was more expensive and more effective.

Univariant sensitivity-analysis showed that when the price of the NIPT as primary test was EUR76, it was dominant compared with current prenatal screening. It was also cost-effective compared with the NIPT as a contingent test (EUR9,869 per extra DS case detected).

The study shows that NIPT had higher detection rates for DS in different scenarios, but the cost constitutes a limiting factor for implementation in the Basque Health System.

Despite several therapeutic options existing for the patients with type I diabetes, the patients are still at high risk for severe acute and chronic complications (1). Pancreatic islet transplantation is a promising therapy to achieve good glycemic control with no or little additional insulin (2). This study was to evaluate the effectiveness, safety, economics and social ethics of islet transplantation (IT) for the patients with type I diabetes.

We searched PubMed, Cochrane Library, CNKI and CBM to retrieve eligible literatures. The values of H1bAc before and after transplantation, the rates of insulin independence and functional islet graft at the last follow-up, and the insulin dose per patient-day were analyzed. Descriptive statistics, t tests and random effects meta-analyses were used in the study.

Totally 21 original papers with 488 cases from 9 different countries were reviewed and analyzed. The studies showed that the H1bAc was decreased from 7.7 percent (95 percent Confidence Interval, CI: 7.4, 8.1) before IT to 6.2 percent (95 percent CI: 5.9, 6.4) after IT. At the last follow-up, the rate of insulin independence was 48.96 percent (95 percent CI: 31.32, 66.73) and the rate of functional islet graft was 65.79 percent (95 percent CI: 47.06, 82.21). The daily insulin requirement dropped from 0.52U/kg/d to 0.21 U/kg/d. The main adverse events of islet transplantation were bleeding (7.01 percent) and the complications related to immunosuppression therapy (6.37 percent), but they were less than those of whole pancreas transplantation.

Another study with a 20-year follow-up also showed that the cost-effectiveness of islet transplantation (USD47,800 per QALY) was better than that of insulin therapy (USD71,000 per QALY). In spite of the better evidences of islet transplantation, the insufficient organ donation and issues of cell purification and immunological rejection limited islet transplantation's widespread utilization (1).

The islet transplantation therapy for the patients with type I diabetes has a potential to achieve insulin independence and better cost-effectiveness, and is relatively safe. But there are some obstacles for its wide utilization.

High-intensity focused ultrasound (HIFU) is a non-invasive ablative technique to treat breast fibroadenomas and benign thyroid nodules. A rapid Health Technology Assessment (HTA) was commissioned to inform the Changi General Hospital's decision on procuring a HIFU system.

A systematic literature search was conducted for systematic reviews, HTA reports and clinical practice guidelines on the clinical effectiveness of HIFU systems with the following PICO elements:

Patients = patients with benign breast fibroadenomas or thyroid nodules

Intervention = HIFU

Comparator = conventional treatment

Outcomes = clinical outcomes

Retrieved studies were summarized in a narrative synthesis.

A few small case series showed reduction in volume of fibroadenomas/nodules in the short term and side effects were minor. Additionally, in HIFU for benign thyroid nodules, conference abstracts described a small open-label, randomized controlled trial where patients receiving HIFU had nodule volume reduction of over 30 percent compared to no reduction in the observation group, at 6 months; and a small non-randomized controlled study where volume reduction was about 70 percent in patients receiving HIFU compared to active observation.

Recent clinical guidelines do not mention HIFU as a therapeutic option for fibroadenomas/nodules.

Major United States health insurers do not cover HIFU and consider it experimental, investigational or unproven. In Germany, HIFU for breast fibroadenomas and benign thyroid nodules are covered by some insurers under special integrated care contracts.

HIFU for fibroadenomas/nodules is a technology still developing its evidence base. The peer-reviewed literature comprises a few small case series and two controlled trials showing fibroadenoma/nodule reduction in the short term (up to 12 months) but no long term outcomes. Professional opinion from current guidelines does not mention HIFU as an option.

It may be prudent to await stronger evidence on long-term patient-important outcomes before offering the treatment as a hospital service. HIFU may be suitable for further clinical research.

Popliteal artery aneurysm (PAA) is the most common peripheral arterial aneurysm and the second most common aneurysm after abdominal aortic aneurysm (AAA). It presents a risk of occlusion, which may lead to acute ischemia and leg amputation. To prevent these risks, asymptomatic PAA >2cm and symptomatic PAA must be treated. Although open PPA repair (OPAR) is still the gold standard, endovascular PAA repair (EPAR) is increasingly used to manage PAA. The objective of this study is to compare the cost of these two medical procedures from the hospital perspective.

Data were retrieved from the administrative database of Lausanne University Hospital (CHUV – Switzerland). Based on diagnostic codes and medical procedure codes, we selected all patients who underwent OPAR or EPAR between 2011 and 2015. Patient's age, length of stay and cost were compared between both groups using Student t-test.

We included seventy-three patient stays (OPAR forty and EPAR thirty-three). Gender balance was identical between groups (97 percent of male), but age was statistically significantly different (OPAR 67.5, EPAR 73, p = .04). EPAR induced shorter mean length of stay (5.1 days versus 11.7 days, p = .0000) and lower mean global cost (CHF 16,555 versus CHF23,514, p = .0085). Cost of procedure amounted to CHF 9,536 for OPAR versus CHF 3,848 for EPAR, medical supply and implants amounted to CHF 1,284 for OPAR versus CHF 7,041 for EPAR and other costs of hospital stay amounted to CHF 12,694 for OPAR versus CHF 5,666 for EPAR. (CHF 1.00 = USD1.00 = EURO 0.93)

With higher patency rate, OPAR is still associated with better medical outcomes than EPAR. But EPAR is significantly less costly than OPAR. Implant cost of EPAR is more than offset by longer length of stay and operating time of OPAR.

The purpose of the study was to evaluate different type and manufacturers of intensive care ventilators in order to support the healthcare decision-making process about the choice to adopt the best available technology for ventilation of pediatric patient in intensive care units at Bambino Gesù Children's Hospital.

The technology assessment process was developed by using a new methodology, the Decision-oriented Health Technology Assessment (HTA) (DoHTA), a new implementation of the European Network for Health Technology Assessment (EUnetHTA) CoreModel, integrating the Analytic Hierarchy Process (1). A literature review was carried out to gather evidence on safety and overall effectiveness of different kind of intensive care ventilators, with several ventilation modalities and strategies. The synthesis of scientific evidence, and results of the specific context analysis resulted in the definition of components of the decisional hierarchy structure, consisting in detailed characteristics of the technology's performances covering the aspects on feasibility, safety, efficacy, costs, and organizational and technical characteristics of the technology. A subgroup of these indicators has been included in a checklist form for the evaluation of different type and manufacturers of intensive care ventilators, each of which was tested in three independent runs performed in three different departments. In addition, an economic evaluation was also carried out.

Preliminary DoHTA results showed that the domains with the highest impacts within the evaluation are safety and clinical effectiveness (34.8 percent and 25.7 percent, respectively) followed by organizational aspects, technical characteristics of technology and costs and economic evaluation. The final objective is to define the alternatives’ ranking through a comparison between alternative technologies’ performances.

The technology assessment project allowed to identify strengths and limits of the most recent intensive care ventilator’ models in the specific contexts of use by involving all health professionals interested, and eventually identify the best option for the hospital.

Many countries that have used Bacillus Calmette-Guérin (BCG) vaccine against tuberculosis (TB) have switched from universal vaccination of infants and children to selective vaccination, or discontinued with vaccination at all. The aim of the study is to assess the costs and cost-effectiveness of BCG vaccination in Estonia.

A Markov cohort model and budget impact analysis were used to compare the current, universal BCG vaccination to selective and non-vaccination strategies. The epidemiological and economic impact of BCG vaccination were estimated for the period 2018–2032 following the hypothetical change in the vaccination policy in 2018. The results were presented as the cost per case of TB adverted, changes in the occurrence of TB and yearly (undiscounted) costs associated with vaccination and TB treatment.

In a cohort of 13,500 infants over a time-period of 15 years Estonian universal BCG vaccination prevents around two TB cases compared to selective or non-vaccination strategies. The cost per one TB case averted for the universal strategy compared to non-vaccination strategy was EUR12,234 (EUR4,059–28,748 in sensitivity analysis) and compared to selective vaccination EUR3,847 (EUR504–10,568). The number of TB cases in 0–14-year old children in 2032 was estimated to be 1.3 for universal vaccination, 2.7 for selective and 2.9 for non-vaccination strategy. The total costs of vaccination and TB treatment in 2032 were estimated to be EUR23,764, EUR16,459 and EUR7,553 respectively.

The cost per case of TB averted is dependent on vaccine efficacy, and is high compared with the cost of treating one case of TB. At the same time, the total costs of BCG vaccination and TB treatment are marginal compared to other vaccination programs used in Estonia. Despite the limited budget impact, several organizational challenges need to be addressed if the universal program is replaced with selective BCG vaccination.