Recently, a number of mobile apps to record symptoms and medication by patients themselves have been developed. These apps are expected to improve the patients' symptoms through self-management, and to enable a smooth decision making through effective communication between doctors and patients. “Itami Renrakucho” (Pain Diary, Welby Inc.) is one of these apps that records body pain, medication, physical conditions, and activity in life. We examined the relationship between pain and medication/activity based on its data.

Data between 25 December 2015 and 9 December 2016 were used. Medication and degree of pain (0-10, low < high) were recorded at morning, daytime, evening, and bedtime. Of ninteen activities, up to three were recorded about whether they could or could not do them. We compared the degree of pain among different frequency/timing of medication, or activities that they could or could not do.

Data included 708 individuals. Among 561 individuals who answered about pain, the mean (Standard Deviation, SD) degree was 5.0 (2.3). The mean degree in individuals taking 0, 1, 2, 3, and 4 times medication a day were 4.6, 5.0, 5.4, 5.5, and 6.2, respectively. Regarding medication timing and degree of pain in two consecutive time points (t0, t1), regression towards the mean occurred for individuals without medication in both time points. The degree changed more for individuals taking medicine only at t0, but not for those taking at both time points. Weaker pain was reported when they could do hanging laundry and rising early than when they could not, but they could do shopping, strolling and light exercise even having stronger pain.

We showed a tendency of relationship between pain and medication/activity based on the data from the app. More data and connecting to claims will help us to show characteristics of patients and diseases, select a treatment, and evaluate a medicine.

Health Technology Assessment (HTA) aims at providing decision makers with relevant data, matching different perspectives, with an evidence-based approach. The most common framework used is the European Network for Health Technology Assessment (EUnetHTA) Core Model (1): HTA may be further supported by a Multi-Criteria Decision Analysis (MCDA) (2,3), leading to a final quantitative synthesis, facilitating the appraisal phase.

This project presents a multi-dimensional comparison of the technologies available for the treatment of diabetic macular edema (Ranibizumab, Aflibercept, Dexamethasone implant and off-label Bevacizumab), comparing three Italian Regions: Lombardy, Liguria and Veneto.

The nine EUnetHTA dimensions were first prioritized by seventeen multidisciplinary evaluators. Thereafter a further nine professionals attributed a 3-level rating score (from “1” not performant, to “3” most performant) to each dimension and sub-dimension, after carefully assessing the three HTA reports. In conclusion, the investigation of statistically significant differences between the attributed scores of the evaluators was conducted, using a multi-variate analysis.

No statistically significant differences were reported in the prioritization of each dimension, except for the equity (more important in Liguria and in Lombardy) and the economic financial dimensions (more relevant in Veneto and in Lombardy).

Notwithstanding the evaluators’ different professional titles, job roles, center size, and various Regional contexts, they attributed similar scores to the HTA dimensions during the appraisal phase (even though conducted in different years, in 2015 and 2016). This finding demonstrates the robustness of both the evaluations and the final MCDA results: i) no statistically inter-regional significant differences emerged regarding Ranibizumab and Aflibercept (p-value >.05); ii) no statistically significant inter-regional differences emerged regarding Dexamethasone, except for the assessments in the clinical dimensions (p-value = .026), since in Lombardy Region the evaluation was carried out earlier in the technology's life-cycle.

Dexamethasone was consistently attributed a higher total score, considering the final normalised weight derived from the MCDA approach (p-value =.001).

Patients who experience Transient Ischaemic Attack (TIA) should be assessed and treated in a specialist clinic to reduce risk of further TIA or stroke. But referrals are often delayed. We aimed to identify published studies describing pathways for emergency assessment and referral of patients with suspected TIA at first medical contact: primary care; ambulance services; and emergency department.

We conducted a scoping literature review. We searched four databases (PubMed, CINAHL, Web of Science, Scopus). We screened studies for eligibility. We extracted and analysed data to describe setting, assessment and referral processes reported in primary research on referral of suspected TIA patients directly to specialist outpatient services.

We identified eight studies in nine papers from five countries: 1/9 randomized trial; 6/9 before-and-after designs; 2/9 descriptive account. Five pathways were used by family doctors and three by Emergency Department (ED) physicians. None were used by paramedics. Clinicians identified TIA patients using a checklist incorporating the ABCD2 tool to describe risk of further stroke, online decision support tool or clinical judgement. They referred to a specialist clinic, either directly or via a telephone helpline. Anti-platelet medication was often given, usually aspirin unless contraindicated. Some patients underwent neurological and blood tests before referral and discharge. Five studies reported reduced incident of stroke at 90 days, from 6–10 percent predicted rate to 1.2-2.1 percent actual rate. Between 44 percent and 83 percent of suspected TIA cases in these studies were directly referred to stroke clinics through the pathways.

Research literature has focused on assessment and referral by family doctors and ED physicians to reduce hospitalization of TIA patients. No pathways for paramedic use were reported. Since many suspected TIA patients present to ambulance services, effective pre-hospital assessment and referral pathways are needed. We will use review results to develop a paramedic referral pathway to test in a feasibility trial.

In Brazil, the pharmaceutical sector has requested an individual incorporation in the Brazilian public health system (SUS) for each new drug for multiple sclerosis that receives sanitary authorization for marketing. Horizon Scanning within Brazilian Ministry of Health has played a key role in the recommendations made by the National Committee for Health Technology Incorporation (CONITEC). Horizon Scanning seeks to predict which technologies have potential to impact health care in SUS, before their formal request. This study aims to present the impact of horizon scanning in two assessments made by CONITEC on drugs to treat Multiple Sclerosis.

Grey literature was searched to find new and emerging drugs for multiple sclerosis treatment. Regulatory agencies were also searched: European Medicines Agency (EMA), Food and Drug Administration (FDA) and Brazilian Regulation and Health Surveillance Agency (Anvisa). A pre-defined standardized form was used. Information extracted about each drug was identified as: drugs name, mechanism of action, indication, administration route, finished phases of clinical trial and registration in other countries.

In 2014, horizon scanning identified seven drugs while CONITEC was assessing Fingolimod for multiple sclerosis. In this case, the drug's administration route was a differential, as only three new drugs identified were also orally administrated. Thus, Fingolimod received a positive recommendation for incorporation. In 2016, horizon scanning identified fourteen drugs while Teriflunomide was under assessment. At this moment, the orally administrated Fingolimod was already available and it was identified other eight new drugs with the same route. Therefore, the initial recommendation was against its incorporation.

Horizon scanning has proved to be of major importance for assisting recommendation-making process of the committee. In the two cases presented, horizon scanning information could predict which technologies were being developed and could be registered in Brazil. These new technologies had influenced the recommendations made by CONITEC's members. As a result, a horizon scanning section in all CONITEC's reports became mandatory.

Pediatric parenteral nutrition is mainly used in neonatal intensive care units (NICU) and requires close collaboration with the hospital pharmacy, especially for manufacturing time, application, preparation and delivery (1). In this context, a Health Technology Assessment (HTA) to evaluate an automatic system compared with a manual system was carried out.

The Decision-oriented HTA (DoHTA) method (2), coordinated by Bambino Gesù Children's Hospital (BGCH) HTA Unit, was applied to carefully assess the technology. It was developed starting from the European Network for HTA (EUnetHTA) Core Model® and integrated with the Analytic Hierarchy Process (AHP). Its purpose is to identify all the relevant assessment aspects of automatic system integrating the evidence from the scientific literature with experts’ judgments and the specific context analysis for BGCH: an evaluation scheme inherent safety, clinical effectiveness, technical and organizational aspects (represented by a decision tree at three levels: dimensions of evaluation, I and II level indicators) was subsequently created. A weight was finally associated to each identified element and the alternatives’ ranking was defined.

The study results show a “performance value” associated with the automatic system greater than about thirty-two percentage points compared to the manual system.

At the current state of the scientific evidence and the results of analysis carried out by the working group, it is believed that the choice should be made to introduce the automatic system is available in BGCH.

More specifically, from the point of view of safety, automatic system is safer for both patient and operators; about clinical effectiveness, the system improves the nutritional intake, allows a reduction of post-infusional adverse events and the use of antibiotic therapy; concerning economic aspects, the analysis of available data shows a substantial equivalence between the alternatives considered; the technical-functional aspects show an improvement according to almost all indicators; organizational aspects show a slight improvement in the working and in process management and finally the legal aspects indicate a slight advantage for the automatic system.

In 2013 the Essencial Project launched in Catalonia promotes the identification of low-value practices (LVP) by healthcare professionals and elaborates recommendations to avoid them. This project aims to reduce unnecessary care of health care services which harm outweighs the benefits, resulting in physical, psychological to the patients and wasteful healthcare services. The main objectives are to describe the implementation process at the primary care level and to evaluate the impact of recommendations on general practitioners (GPs) practice.

The implementation process consists in:

(i) Nomination of clinical leaders to promote the project among their primary care teams (PCT) and to lead the implementation activities by identification of barriers and enablers for change in clinical practice towards avoiding LVP.

(ii) Selection of recommendations to be implemented and definition of corresponding activities to be carried out by each PCT according to the specific characteristics of their organizations.

(iii) Development of related indicators and comparison between baseline status

One hundred and sixteen PCT (covering 30 percent of the Catalan population) participated in the pilot experience of implementation. Twenty-one recommendations were selected such as: bisphosphonates in post-menopausal women with low risk of fracture, PSA screening and statins for primary prevention of cardiovascular disease, among others. At 12 month follow-up, use of bisphosphonates were reduced by 21 percent (p = .0005), PSA was reduced by 14 percent (p = .0009). The use of other treatments such as antidepressants, benzodiazepines for some specific clinical conditions decreases with no statistically significant changes.

This is the first experience in Catalonia and Spain of implementation of the recommendations to avoid LVP with early involvement of target professionals. Follow-up results provide information about the early impact of recommendations at primary care level. Our challenge is to implement the recommendations at hospital level.

Severe aortic stenosis with symptoms or left ventricular dysfunction has commonly a poor prognosis. Aortic valve replacement is usually performed for these patients aiming at improving their functional class and survival rate. Transcatheter aortic valve implantation (TAVI) is often presented as an option in patients with high surgical risk for conventional surgical valve replacement.(1) Nonetheless, in this group of patients, the literature has yielded conflicting evidence suggesting that benefits of TAVI for patients of high or intermediate surgical risk is not consistent.(2,3)

This retrospective study aimed to evaluate the mortality rate from a cohort of patients after the correction of aortic valve dysfunction with TAVI. It consisted of a convenience sample of patients at high risk for open surgery for the correction of aortic valve dysfunction treated with TAVI from 2013 to 2016. All included patients were being provided healthcare assistance by a private nonprofit health maintenance organization (HMO) operating in Belo Horizonte, Brazil. Since TAVI is not currently covered by the Brazilian supplementary healthcare system, reimbursements were enforced by lawsuits. Data was extracted from an administrative database, using the software Oracle Business Intelligence®. Continuous variables were expressed as mean and standard deviation. The Kaplan-Meier method was used to adjust the 1-year survival curve using the software STATA 13.1 (Stata Corp, College Station, TX, USA). This historical cohort resulted in no interventions, neither during the course of the instituted treatment nor after the observed outcome. Privacy of subjects and the confidentiality of their personal information were handled in accordance to the ethical principles of the Declaration of Helsinki.

Overall, seventeen patients with a mean age of 80.5 years (68-91) underwent TAVI; 59 percent were women. Peri-operative mortality rate was 23.5 percent (n = 4) and accumulated overall one-year mortality was 35.3 percent (n = 6). Mean length of hospital stay was 26.9 ± 16.6 days. Prolonged hospital stay (≥ 7 days) occurred in 14/17 cases (82.3 percent), with a maximum of 51 days.

In similarity to our findings, other authors described a high early and late mortality rate in patients undergoing TAVI. The strategy to use TAVI as an alternative in patients at high risk for open surgery is still under debate and should be carefully discussed taking into consideration the local team expertise as well as local healthcare available recourses.

The introduction of new biologic treatments has radically changed the management of Immune-mediated inflammatory diseases (IMID). Due to the high costs of the treatments a strong control and monitoring of claims databases could help decision makers to understand the consequences of their decisions.

The objective of the study was to identify the cohort of biologics treatment-naïve patients in the years 2011–2013 in the Lazio region (6 millions of inhabitants), in order to investigate the parameters influencing the biologic treatment expense at the regional level.

Patients were enrolled based on administrative databases of the Lazio region. Treatment-naïve patients were defined as subjects who did not have a prescription in the two years before the index prescription. Switcher patients were defined as those who had an Anatomical Therapeutic Chemical classification (ATC) prescription different than the one at enrolment, within one year of the index date. Treatment adherence was estimated as the number of doses actually prescribed as compared to the number indicated in the Summary of Product Characteristics (SPC).

From a total number of 10,120 patients treated with biologic drugs between 2011–2013 in the Lazio region, 2,929 were estimated as treatment-naïve patients (42 percent male). The most frequently used drugs were etanercept (31 percent), adalimumab (30 percent) and infliximab (17 percent). Considering the disease treatment distribution, 28.6 percent of patients were treated for rheumatoid arthritis, 25.5 percent for psoriatic arthritis, 16.4 percent for psoriasis and the remaining patients for other diseases. Some patients switched biologic therapy (367), of which 22.6 percent were within the first 120 days. Total mean adherence was estimated in 87.7 percent: 21.5 percent of patients showed a low adherence (SPC< 60 percent) while 18.1 percent were estimated as dose increase patients (SPC>110 percent), 11.4 percent for rheumatic diseases, 32.3 percent for dermatological diseases and 26.9 percent for inflammatory bowel disease.

The study provides a map of the current treatment settinga with biologics in the Lazio region considering the disease, adherence and prescribed treatments. A considerable number of treatment-naïve patients were identified (2,929), 12.5 percent of whom switched ATC within 1 year. Total mean adherence was estimated in 87.7 percent, low adherence occurred in 21.5 percent of patients, while dose-increase was in 18.1 percent.

Multiple Sclerosis (MS) is an inflammatory neurological disease. The standard treatment is disease modifying drugs which may alleviate symptoms and slow the progress of disability, but not lead to remission. Autologous Hematopoetic Stem Cell Transplantation (AHSCT) is a new technology for treatment of MS in Norway. Disease remission in some patients treated with AHSCT has been postulated, in particular in patients in the early course of disease with high disease activity classified as having Relapsing-remitting multiple sclerosis (RRMS), but severe complications have also been reported.

We conducted a systematic literature search. No restrictions were set in terms of study design, although case series should include at least ten patients with a majority having RRMS. We performed a cost analysis from a healthcare perspective with a time frame of one year.

One randomized controlled trial (RCT) (n = 21, RRMS = 7), one registry study (n = 345), and seven case series (n = 442, RRMS = 277) without control groups were included. Estimated transplant-related mortality was 2 percent or lower. Serious adverse events, such as infections, were common during follow-up. Stabilization or improvement in neurological status was reported in 63 percent to 89 percent of the patients after three years, and the number of Gd+ and T2 lesion volume assessed by Magnetic Resonance Imaging was reduced. The quality of evidence assessed using the “Grading of Recommendation Assessment, Development, and Evaluation” tool was low for transplant-related mortality and very low for the other outcomes. HSCT costs were approximately between 480,000 and 605,000 Norwegian kroner per patient in the intervention year. A heterogeneous disease progression, significant risks associated with the method, lack of effective treatment options, and uncertainty about the benefit versus risk, implies that any decision to offer HSCT in the treatment of MS is ethically challenging.

The main limitation in this HTA is the absence of controlled studies, which introduces a high risk of bias. Studies without control groups, including mainly patients with RRMS, reported that disease activity could be delayed or stopped for a period of up to three years in several patients, whereas adverse events were common. Ethical considerations are associated with significant uncertainty of benefit versus harm. The low level of evidence implies the need for controlled trials.

Ischaemic heart disease is the leading cause of death worldwide. Magmaris™ is a new drug-eluting resorbable stent used for coronary reperfusion during a balloon angioplasty. Magmaris™ is composed of absorbable magnesium scaffold and its surface is coated with bioresorbable poly-L-lactide, which incorporates Sirolimus. Magmaris™ has theoretical advantages as the stent body disappears after vascular constrictive remodeling. It would provide the stability and elasticity of non-resorbable metal stents, but without long-term problems such as endothelial dysfunction, delay in endothelialization, risk of thrombosis and complications due to long-term antiplatelet medication. The objective of this work is to assess efficacy and safety of Magmaris ™ in patients with angina or silent ischaemia.

Early assessment of Magmaris™ identified through the Early-Awareness and Alert-System, “SINTESIS-new technologies”, of The Instituto De Salud Carlos III (AETS-ISCIII). The searched databases were: MEDLINE (PubMed), EMBASE, WOS, Clinical Trials and Cochrane Library. Clinical studies using Magmaris™ published in any language until December 2016 were reviewed.

One prospective, non-randomized, non-controlled, multicenter, clinical trial with two publications was retrieved. The first publication (123 patients) showed mainly imaging outcomes of angiography, intravascular ultrasound and tomography at 6 months of follow up. The second publication (118 patients) with data from 12 months of follow up also reported: Target lesion failure in four patients (3.4 percent; 95 percent Confidence Interval, CI:0.9–8.4); one target-vessel myocardial infarction (0.8 percent; one myocardial infarction (0.8 percent); two clinically driven target lesion revascularisation (1.7 percent) and two clinically driven target-vessel revascularisation (1.7 percent). No definite scaffold thrombosis was observed. No procedural complications were reported. This trial is expected to continue up to 36 months of follow up.

Clinical data show that Magmaris™ seems to be an effective and safe treatment in patients with angina or silent ischaemia undergoing balloon angioplasty. More research specially randomized controlled trials are necessary to confirm these results.

National Health Technology Assessments (HTAs) for medical devices are crucial to regulate the quality and costs of healthcare systems. However, there is diversity in several aspects among European countries. Consequently, controversial results might arise, generating contrary reimbursement decisions. The European Network for Health Technology Assessment (EUnetHTA) is an interface platform for the harmonization of HTA information across Europe. The European Commission expects national uptake of a European HTA. Thus, European HTAs might overcome the diversity of national HTA requirements.

We aimed to compare German and European HTAs for medical devices regarding processes, methods, timelines, and involvement of medical device companies. Therefore we analyzed guidelines, requirements, and output of EUnetHTA and compared those aspects with the German G-BA (Federal Joint Committee, Gemeinsamer Bundesausschuss) standard and IQWiG (Institute for Quality and Efficiency in Health Care, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen) methods.

We found differences between the European and German HTAs for medical devices regarding timelines, involvement of medical device companies, body of evidence, use of surrogate endpoints, and methodology. European HTAs for medical devices reflect the clinical reality by integrating the existing evidence (including real world data) and by using comprehensive statistical methods for medical devices. In contrast, German HTAs for medical device-based technologies are long lasting and are often restricted to a small body of evidence.

As a conclusion, similar to pharmaceuticals, the European HTA framework might also become a worldwide platform for HTAs of medical device-based technologies with the potential to harmonize reimbursement decisions and patients health care across countries on the basis of clinical reality.

Rapid reviews are an attractive tool for Health Technology Assessment (HTA) as they may be a support in decision making when time and resources are limited. Rapid reviews are carried out in few weeks (from 3 weeks to 6 months) and require adjustments from standard systematic review methods. Methodology on how to carry out rapid reviews is still debated and guidance regarding the most suitable method to apply is lacking. Kaltenthaler (1) has recently proposed a checklist of items to be considered when undertaking a rapid review. We appraised our rapid assessment on the use of frequency domain (FD)-optical coherence tomography in percutaneous coronary interventions, based on a rapid review of the literature, using the items proposed (1).

The checklist reports four key points to consider when planning a rapid review: (i) scoping search - needed to quantify the available evidence and to inform rapid review protocol, (ii) results reporting – considering heterogeneity of intervention, comparators, and outcomes, (iii) clear communication with policy makers - ensuring that review responds to the policy question and (iv) reporting on methods - methodology used, strengths and limitations.

When we applied the checklist proposed by Kaltenthaler (1) to our rapid review on the use of FD-optical coherences tomography it resulted that: the scoping search revealed no useful systematic reviews to answer policy-makers questions and a high number of relevant studies. For results presentation, we used a narrative synthesis reporting outcome data grouped in domains previously defined by an evidence profile. Domains consisted of technical performance, safety, efficacy, and change in management. No meta-analysis was performed due to paucity of randomized controlled trials (RCTs) for the efficacy domain and high heterogeneity in outcomes measures for technical performance. Analysis of some of the outcomes was extremely time-consuming (technical performance) and did not provide particularly useful information for the commissioning body. A clearer and more intensive dialog with policy makers to adjust extent of research question and/or outcomes to be investigated would have probably improved usability for final users. Description of methods was partial.

The checklist by Kaltenthaler (1) helped us to reflect on the method we used to carry out rapid reviews and to pinpoint possible solutions to improve it.

Urinary tract infections (UTIs) are common in female patients in general practice. These bacterial infections affect half of all women at least once in their life. Antibiotics are usually prescribed for UTIs, and continuous low antimicrobial prophylaxis is administered to patients at high risk of recurrent UTI (rUTIs) (1). However, a major concern arises due to the increased rates of severe treatment-related side effects and emergence of antimicrobial resistance, which makes rUTIs management more challenging while seeking the use of more expensive alternatives. On this basis, clinical evaluations of rUTI interventions should be accompanied by economic evaluations in order to guide healthcare policy and decision processes about healthcare resources allocation. The aim of this work was to perform a cost-effectiveness analysis of a novel effective non-antibiotic treatment option for prophylaxis of female patients with a history of rUTIs, based on intravesical administration of hyaluronic acid (HA) plus chondroitin sulfate (CS), as compared to recommended 1st-line antibiotic therapy (2).

A cost-utility analysis was performed in order to estimate the effectiveness of each treatment, according to the number of UTIs annual episodes, and the incremental cost-effectiveness (ICER) for patients with UTI, starting from data collected during a multicentric observational case-cross-over clinical trial involving seven European centers (2). The economic model includes the costs of HA treatment and the costs associated with each UTI, such as costs of UTI diagnostics and antibiotic treatment, additional care by the elderly-care physician, additional nursing care, and hospitalizations, as well as the expected QALY, measured through the Short Form Health Survey (SF-36) questionnaires administered to patients, for both groups (3).

At this stage, preliminary findings suggest that HA plus CS is a cost-effective alternative to antibiotics for the treatment of recurrent UTIs, that could reduce UTIs events in female patients with a history of recurrent UTI at an acceptable cost.

The results of this study support the use of HA plus CS against antimicrobials as 1st-line therapy in the management of rUTIs.

In 2015, the province of Québec, Canada went through a major restructuration in its healthcare system which resulted in regional institutional merging. Our hospital-based Health Technology Assessment (HTA) unit is now part of a large network comprising fourteen institutions covering an area of 12,734 km2. This new organizational context poses major challenges in terms of addressing various local needs and for involving stakeholders into our assessments. In this paper we present how we addressed these difficulties.

This case study presents the procedural method we developed for involving local and regional stakeholders into an HTA concerning the need to extend a regional prenatal ultrasound screening program. We describe how we collected local data and networked local to regional stakeholders for producing the assessment and recommendation.

After completion of the literature review on first trimester ultrasound screening, local data from each institution were collected using a combination of focus group meetings with local managers, gynecologists and ultrasound technologists. Overall, fifteen people were consulted on diverse regional sites, including two services users. In order to assess the perception of the results regarding efficacy, users preferences, cost and organizational impact of expanding the screening program, people were asked to complete an online survey. The results of this survey were then used to write a first draft of a recommendation. A second survey was generated in order to obtain agreement of the fifteen people regarding the recommendation. Overall, this method decreased the time required to complete the assessment and reduced project operating costs. However, divergence of opinions may be difficult to resolve by this method and many rounds of consultation may be needed.

Our procedural method using a combination of focus groups and online surveys for collecting local and regional data and opinions from stakeholders and support recommendation, has succeeded to provide well contextualized information for supporting a decision.

Europe currently has the highest proportion of older people in the world and is expected to maintain this leading position for the next 50 years. A teleradiology service for frail patients living at home or in nursing-homes (R@dhome), funded by the Italian Ministry of Health, has been operating from June 2013 to May 2015 (1). The goal was to offer, within the path of home care patients, radiologic care for fragile elderly patients (2). In this report of the study a secondary outcome was evaluated; the perceived quality for patients and caregivers undergoing home radiology.

The study was a randomized controlled trial (RCT) with 136 patients; 71 cases and 65 controls. The perceived quality assessment was only performed among home inpatient group cases, at home or in nursing homes and not in the control group patients (who had treatment in a hospital). The assessment instrument was a semi-structured interview based on the benchmark system SERQUAL®. The identified dimensions of quality were: tangible aspects, reliability, responsiveness and empathy in a subpopulation of non-dementia patients. Eligible subjects were interviewed between May 2014 and May 2015.

The percentage of satisfied patients, evaluated on the dimensions of perceived quality, was 97.7 percent. The main reasons given were: short waiting time, best comfort and safety, efficiency, operator's kindness and less need to travel for the treatment.

R@dhome benefits are not limited to clinical or financial aspects but ethical, social and relational advantages have also been shown in this study (3). Given the fragility of the patients, positive results were mostly achieved by reducing the risk of trauma in transport between their home and the hospital.

In Paraguay the main cause of Traumatic Brain Injury are the accidents in ground transportation. According to data from the Basic Health Indicators 2013 of the Ministry of Public Health and Social Welfare, the regions with the highest rate of accidents in ground transportation are located in the rural zone of the country. Linguistic or communication disorder, attention and memory are the first functions that must be rehabilitated. Is essential to improve the patient's language skills to intervene the other cognitive functions. The objective of this study is to determine if free augmentative communication systems have the characteristics necessary for the cognitive rehabilitation of the language to provide a low cost solution for Traumatic Brain Injury patients in rural areas of the country.

A list of seven characteristics that contributed to verbal comprehension and expression, reading and writing, logical-verbal reasoning and numeration and calculation were compiled and compared to the Gazespeaker, which is a free augmentative communication system.

The Gazespeaker meets the seven characteristics required for language rehabilitation.

For patients with Traumatic Brain Injury are required low cost tools and ease-to-use like the Gazespeaker. It is a good augmentative communication system which satisfies all the characteristics required for a good language rehabilitation. In addition, this free software allows the use of an eye tracking device that can be applied to patients with Traumatic Brain Injury and severe motor deficit.

The Veneto Region established a Technical Panel for Continence (TPC) with the purpose of producing guidance for aids based on a Health Technology Assessment (HTA) approach. TPC is a multidisciplinary experts group that involves local clinicians, pharmacists, health economist and patients associations. Among its tasks, TPC can issue recommendations in the field of appropriate use, purchasing and distribution for aids. Currently the TPC is investigating aids for ostomy patients in order to provide the first regional guidance on appropriateness and disease management for ostomy.

The Regional Health Technology Assessment Unit (CRUF) conducted a literature review of the evidence on aids for ostomy. Grey literature, and National and Regional laws and regulations were also included in the analysis. TPC discussed the collected evidence by consensus. Final recommendations have been sent to the Regional Technical Committee on Medical Devices (CTRDM) for eventual remarks, before final approval.

The literature review did not retrieve any relevant international studies on the topic, except for the Canadian clinical guidelines on ostomy. The upcoming regional guidance will suggest recommendations on: (i) appropriate patient disease management based on a multidisciplinary team evaluation; (ii) characteristics and selection criteria for ostomy aids and related accessories; (iii) prescribing medical specialists, authorization and distribution features; and (iv) specific indicators for appropriateness monitoring.

The regional guidance on aids and accessories for ostomy aim at ensuring the appropriateness throughout the Regional Health Service. The strict monitoring of agreed indicators is essential for appropriateness compliance and consequently the sustainability of regional medical devices expenditure.

Chagas disease, caused by the protozoan parasite Trypanosoma cruzi, is a neglected chronic condition with a high burden of morbidity and mortality. It affects about 6 million people in twenty-one countries of Latin America, and has recently become a global health concern (1), especially due to immigration from endemic areas into the developed world. Cardiac arrhythmias are common in patients with Chagas cardiomyopathy and amiodarone has been widely used as an antiarrhythmic drug. Amiodarone has been recommended as the treatment of choice for all patients with sustained ventricular tachycardia (2). The objective of this systematic review is to evaluate the effect of amiodarone in arrhythmia patients with the cardiac form of chronic Chagas disease.

Searches was conducted in MEDLINE (PubMed), EMBASE and LILACS from the inception to December 2016. Studies regarding the use of amiodarone to treat arrhythmia in patients affected by Chagas disease were included, and the outcomes were arrhythmia, adverse effects and sudden death. Selection of articles and data extraction were made by two independent reviewers.

The database search found 378 articles but only 9 studies with 373 subjects fulfilled the eligibility criteria. The nine studies selected were composed of case series (two), crossover clinical trials (two), and clinical trials (five). Results showed that amiodarone reduced ventricular extrasystoles in all studies and ventricular tachycardia in eight studies. During treatment with amiodarone, patients in eight studies had side effects. Corneal microdeposits and gastric discomfort were the most common adverse effects present in studies. Three studies reported sudden death during follow-up.

Amiodarone seems to be an effective antiarrhythmic drug for Chagasic patients, reducing uncomfortable symptoms such as tachycardia. This information can be useful in the primary care context, supporting general practitioners to manage Chagas cardiopathy, mainly when specialized cardiologic consultants are not available.

Health Technology Assessment (HTA) processes are extensively used during making decisions on the inclusion of medicinal products in Essential medicines lists. There is a high interest in HTA among specialists in the healthcare sphere and decision makers in Russia. According to a survey of chief physicians 62 percent of them would like to attend HTA educational programs. One of the steps necessary to disseminate HTA in Russia is the exploration of experience and best practices.

Information retrieval using websites of medical institutions in Russia were observed.

As a result, it was found that educational program “Modern requirements for conducting health technology assessment” for decision makers in the area of health care is held in Department of organization of medicinal provision and pharmacoeconomics of the I.M. Sechenov First Moscow State Medical University. During this course basic methods of pharmacoeconomic analysis and their practical application, modern schemes of treatment and peculiarities of the conduct of pharmacoeconomic studies in different diseases, issues of HTA at different levels of the health system are covered. More than 1,900 specialists from 12 subjects of Russia (Samara, Nizhny Novgorod, Rostov, Orenburg, Bryansk, Astrakhan regions, Khanty-Mansi Autonomous Okrug, Altai, Krasnoyarsk, Stavropol and Perm territories, the Republic of Tatarstan) attended seminars including heads of regional health authorities, chief specialists of the ministries, chief physicians of hospitals, and heads of pharmacies.

During the educational process the results of pharmacoeconomic analysis and their interpretation at the regional level, legislative changes in the sphere of health technologies circulation, the data requirements for inclusion of a medicinal product in the state lists, the rules of state procurement, and the interchangeability of medicines are highlighted. During educational process the results of pharmacoeconomic analysis and their interpretation at the regional level, legislative changes in the sphere of health technologies circulation, the data requirements for inclusion of a medicinal product in the state Lists, the rules of state procurement, and the interchangeability of medicines are highlighted.

The last five years represented an advanced season for the establishment and reinforcement of the Brazilian Ministry of Health's Horizon Scanning System. The recognition of Horizon Scanning (HS) as a tool for evidence- based decision making has been reflected in the requests for information directed to the Horizon Scanning's team. These requests for information about new and emerging technologies come from cabinets offices and thematic departments of the Ministry of Health. The methodology of Horizon Scanning assessments described in EuroScan's toolkit1 has been applied to guarantee that the information reach stakeholders at the right time. The National Committee for Health Technology Incorporation (CONITEC) was accepted as a member of EuroScan (1) in 2016, and this represented another important step of Brazil's HS System.

In order to provide the specific information requested, the assessments of the technologies are done. So, databases on ongoing clinical trials, commercial pharmaceutical database, registration and licensing sites, proceedings and abstracts of scientific conferences and scientific databases are checked to collect the information. The extent and depth of the assessments depends on the stakeholders needs and time available to complete them. However, information as how the technology works, the clinical burden of disease, if there are available technologies in the Brazilian Public Health System to treat the disease, safety and effectiveness data, the regulatory status in the world as well costs, social, ethical and legal concerns are commonly given.

The information provided using the HS methodology is used by stakeholders for several purposes as to defend the Ministry of Health in the Courts in the typical Latin American phenomena called “judicialization of health;” in assistance of the decision making of incorporation of technologies by the Brazilian Public Health and to support the definition of which medicines would be more strategic for establishment of Public-private partnerships for development of medicines, the named “Productive Development Partnerships (PDPs)”.

The assessment of the technologies and the prediction of its potential for impact has helped the health policy making process in Brazil.