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.

Hepatitis C virus (HCV) infection is one of the main causes of chronic liver disease worldwide. The goal of HCV therapy is to eradicate the infection, which results in eliminating detectable circulating HCV after cessation of treatment, to prevent complications.

A prospective analysis was undertaken in the primary referral center in Turin. Throughout the use of questionnaries submitted to healthcare professionals, clinical and economic data from three different care pathways of HCV treatment were collected and processed. Costs were measured up to 8, 12, and 24-weeks treatment and based on time-driven activity-based costing (ABC) of the two main HCV treatments, Sovaldi and Harvoni. For the ABC analysis, three types of care pathways were considered, based on patient's clinical history resources used: patients treated for 8, 12, and 24 weeks. Gastroenterologists, pharmacists, administrative personel, and storemen were involved in the project. The aim of the analysis was to evaluate the organizational impact of the three different strategies for the treatment of HCV infection with Harvoni or Sovaldi and to estimate the differential cost.

The data indicates that shortening treatment from 24 to 12 weeks and from 24 to 8 weeks leads to a saving of EUR192 and EUR766 for both treatment strategies. When drug costs are also taken into account, the reduction of treatment with shortening treatment from 12 to 8 weeks leads to a saving of EUR15,252.77, a reduction of EUR60,691.07 from 24 to 8 weeks for Harvoni treatment. The reduction of treatment with shortening from 24 to 12 weeks for Sovaldi leads to a saving of EUR37,668.30. The paths of 8 and 12 weeks are those associated with fewer resources in terms of professional's time, costs relating to laboratory tests, and cost of drugs.

The reduction of the amount of time spent by healthcare professionals in the 12 weeks and in the 8 weeks strategies allows a reallocation of the resources employed.

Schizophrenia is a severe mental disease that affects approximately 1 percent of the population with a relevant chronic impact on social and occupational functioning, and daily activities. The aim of this analysis was to evaluate the clinical and economic consequences of long-acting injectable (LAI) treatment in patients with psychotic disorders, with a special focus on schizophrenia, in Italian real world practice.

A retrospective, observational mirror-study was developed to analyze outcomes measure referred to patients with psychotic disorders. Five hospital centers were involved in this study that collected patient level data from clinical databases. Retrospective data for each patient were referred to 6 months before LAI drug administration and 6 months after. A paired-Samples t-test was performed in order to identify statistical differences between pre- and post-LAI administration.

A total number of 308 patients were enrolled in the study (65.6 percent male). Of these 221 were eligible for our analysis (119 with schizophrenia). In the six months after LAI administration period we estimate a 47.3 percent reduction of the antipsychotic drugs (43.8 percent for schizophrenic patients), 94.7 percent reduction of hospitalizations (94.0 percent for schizophrenic patients) and adherent patients increase to 198/221 patients (78/221 in pre-LAI administration period). All differences between pre- and post- LAI administration period were statistically significant with a p< .005. In Italy over 152 thousand schizophrenic treated patients were estimated. Assuming that 20–40 percent of patients are eligible to the Mo.Ma (Model of Management) approach, our model estimates a direct cost reduction during the first year of implementation of around EUR12 million. Additionally, EUR18 million of direct costs in the mid-term and EUR58 million of indirect costs could be saved in the mid-term estimating a total cost reduction, due to the Mo.Ma approach, of about EUR90 million.

This new therapeutic approach could change the cost structure of schizophrenia by decreasing costs with efficient economic resource allocation guaranteed from efficient diagnostic and therapeutic pathways.

The inflammatory marker C-reactive protein (CRP) can be measured by a high-sensitivity assay (hsCRP) specific to vascular inflammation. We aimed to identify published literature on prevalence of elevated hsCRP and associated clinical, economic, and humanistic burden in patients with a history of myocardial infarction (MI).

A comprehensive literature search was performed for publications in English between January 2000 and February 2016 in MEDLINE, EMBASE, and MEDLINE In-Process. Search terms were variations on ‘Post myocardial infarction’, ‘CRP’, ‘epidemiology’ and ‘burden’. Clinical and real-world studies reporting baseline CRP levels in patients with a history of MI were included in the analysis.

Ten studies (prevalence: two; burden: two; both: six) were included. Cut-off points in hsCRP assays varied from >2 mg/L to ≥5.9 mg/L. Prevalence of hsCRP levels >2, >2.3, ≥2.37 and ≥2.9 mg/L were reported in 36 percent, 49 percent, 50 percent and 33 percent of patients, respectively (one publication each). Two publications reported >3 mg/L levels in 27.6 percent and 53.7 percent of patients. Levels of ≥3.3, ≥3.8, ≥4.2 and ≥5.9 mg/L were found in 38.8 percent, 25 percent, 25 percent and 24.7 percent respectively (one publication each). Of six studies reported CV events, four studies found elevated hsCRP levels to be predictive of future risk. Elevated hsCRP levels independently predicted all-cause mortality in four studies and CV mortality in three studies. Three publications included data on comorbidities: Diabetes was associated with elevated hsCRP in two of three analyses; hypertension in one out of two. No consistent associations between elevated hsCRP levels and hyperlipidaemia (one study), stroke or angina pectoris (one study) were found. No study reported economic, resource use or quality-of-life burden.

Due to limited evidence on prevalence of elevated hsCRP and associated burden of illness in patients with a history of MI, further research is warranted. Variations in findings, cut-off points and methods between studies make generalisations difficult.

There is a general consensus on the need to involve patients and the public in Health Technology Assessment (HTA) but questions remain about the best strategies for involving them into HTA structures and activities. The aim of this study was to update a systematic review (published in 2011) on patient and public engagement in HTA.

We searched papers published between January 2009 (end of the initial search) and November 2016 in eight databases and HTA journals using specific search strategies. We identified other publications through citation tracking, Internet search engines, HTA agencies websites, and discussion with experts in the field. Studies in English or French were included if they met the following criteria: (i) qualitative, quantitative or mixed-methods study; (ii) describing patients or public involvement; and (iii) in the HTA field. We extracted information using a pre-established grid including: characteristics of studies, type of activities for involving patients or public, effects on decisions, and factors facilitating or limiting involvement.

We identified a total of 4,762 new publications from the main search strategy. Among them, twenty-eight articles (reporting on twenty-three studies) met the inclusion criteria, whereas seventeen articles were included in the previous systematic review. Research designs are qualitative (18/23), quantitative (3/23) or mixed (2/23). Two main strategies for involving patients and public are generally described. The first is when public representatives participate directly in decision-making processes (participation) and the second is when patient or public input is sought to inform decisions (consultation or indirect participation).

The number of studies on patient and public involvement in HTA has increased in recent years. Findings from this update are mainly consistent with those of the previous systematic review. However, studies are still needed to assess the effectiveness of different strategies for involving patients and the public in HTA.

Most callers to emergency ambulance services are transported to hospital emergency departments (EDs), but ambulance services receive no information on patient outcomes. Pre-Hospital and Emergency Department (PHED) Data is a two-year mixed-methods observational study of the process and potential benefits of linking ambulance and ED data to allow analysis of patient outcomes. We report on our first aim, to examine the potential opportunities and challenges of this data linkage initiative.

We approached six hospital trusts in an English metropolitan area. We used a structured learning log to collect data on the process, time input and reflections. We analyzed these data with descriptive statistics, and qualitatively for themes.

All six trusts agreed to participate. We used an algorithm based on date, time and patient demographics to link data. We achieved a dataset of 775,018 records covering 2012 – 2016, and a linkage rate of 81 percent.

Initial set up tasks within the ambulance service took 30 hours 20 minutes. We then identified five stages of tasks with each hospital trust: negotiating senior approval; exploring data availability; information governance agreement; data transfer; and linking. Mean time spent by the research team on these processes was 30 hours 30 minutes per trust (range: 17 hours 20 minutes to 43 hours 10 minutes), plus additional time from staff of hospital trusts. The most intensive phases were: negotiating senior approval (mean: 8 hours 5 minutes), and data linking (mean: 12 hours 40 minutes). The stage which took the longest was information governance (mean: 19 weeks).

Key themes included the positive attitudes of trusts to participating, the range of decision makers involved, and the need for sustained input from the research team.

We found the process of data linkage was feasible, but requires dedicated time from research and trust staff, over a prolonged period, to achieve set up. Linked data are now being analyzed.

Chagas disease, caused by the parasite Trypanosoma cruzi, affects more than seven million people worldwide and it is considered by the World Health Organization (WHO) a neglected tropical disease (1). About one third of Chagas patients develop gastrointestinal disorders, such as dysphagia and achalasia. Management of the disease focuses on symptom improvement and drugs that relax the lower esophageal sphincter pressure (LESP), such as isosorbide and nifedipine. However, the use of these therapies is doubtful because of their side effects and palliative approach (2). The objective of this systematic review is to assess the effectiveness of isosorbide and nifedipine on gastrointestinal manifestation of Chagas disease.

We searched MEDLINE, EMBASE and LILACS databases to retrieve potentially relevant articles from inception to December 2016. Inclusion criteria: clinical trials, cohorts or cross-sectional design; adults (>18 years old); assessment of effects of isosorbide or nifedipine on gastrointestinal symptoms in Chagas patients. Two reviewers independently screened titles and abstracts, selected eligible studies and extracted data from each study. PROSPERO registration number: CRD42017055143.

Eight studies were included (two case series, two clinical trials and four crossovers). Three studies evaluated the effect of isosorbide in LESP and three in esophageal emptying. All of them found that isosorbide rapidly reduces LESP and increases esophageal emptying rates, improving dysphagia. However, several patients reported collateral effects, such as gastroesophageal reflux, headaches and dizziness. One study evaluated the effect of nifedipine on LESP and one on esophageal emptying. Nifedipine decreased LESP, but there was no effect on esophageal emptying.

The available evidence shows isosorbide is effective in the management of gastrointestinal symptoms. Frequently health care of Chagas disease patients is delivered by primary care physicians. So, information on effectiveness of interventions can be aggregated to clinical guidelines, having an important value to inform general practitioners on the decision-making process regarding treatment of this group of patients, avoiding referencing to a specialized care.

Value added medicines (VAM) are medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers through drug repositioning, drug reformulation or drug combination (1-3). Recently, the European Commission, through the Safe and Timely Access to Medicines for Patients (STAMP) program, considered the issue of VAM development and regulatory process. Current Health Technology Assessment (HTA) tools may not fully capture the benefits of VAM, which could lead to obstacles for patient access to VAM in several European countries (1). The study objective was to identify how HTA frameworks should evolve to reflect VAM value.

HTA expert interviews were performed as a preparatory step to an advisory board meeting. The following topics were addressed: (i) Eligibility for HTA and early HTA dialogues; (ii) Attributes that should be considered in HTA; (iii) HTA methodology; and (iv) Involvement of stakeholders in HTA.

VAMs bring additional benefit to patients and society. Therefore, the possibility for VAM assessment on a voluntary basis and within the appropriate assessment patterns/tools should be, in principle, included into HTA frameworks, as well as into early HTA dialogues. HTA should be patient-centric, and attributes such as patient preference, adherence, and patient reported outcomes should be considered where relevant. Unmet patient needs and disease burden should be used in a transparent and reproducible deliberative process. All these attributes should be used as explicitly and meaningfully weighted appraisal modifiers. HTA methodology should be comprehensive and should integrate societal perspectives. Patient representatives should take part in the decision-making process.

Current HTA frameworks should evolve to enhance VAM value recognition and encourage industry investment in medicines with high potential value for society.

The infectious Diseases Institute (IDI) is a research institute at the College of Health Sciences, Makerere University. Over the years, the number of research studies has greatly increased with an average of fifty active studies per year. Because of the voluminous study activities, investigators were faced with inadvertences of ethical approval deadlines (1). In 2015, a centralized electronic Regulatory Affairs Information System (RAIS) was developed and piloted to track the regulatory process of the entire research projects. RAIS is a web-based system, developed using a Net framework and runs on any operating system using a web browser such as “Google Chrome” and “Mozilla Firefox”.

A signed approval letter from an accredited Research Ethics Committee, National Drug Authority and Uganda National Council of Science and Technology, the reviewed protocol, consent forms and data collection tools are uploaded electronically into the RAIS with study staff contact information, CVs and Good Clinical Practice (GCP) certificates. RAIS sends automatic “no reply” emails to the investigators and research administration notifying for the need of annual renewal 56, 28 and 14 days before the expiry date of the approvals. The investigator or designated person prepares the application package which is then forwarded to the Research Regulatory Officer for review and submission to the regulatory authority.

From January 2015 to November 2016, fourty-three ongoing studies were uploaded to the RAIS of which eleven were clinical trials, twenty-one observational studies, seven diagnostic and four implementation studies. Studies that obtained their annual approvals before the expiry date was 90.7 percent, compared to 29 percent that had reported early submission for annual renewal between January 2013 and December 2014. RAIS has enabled continuity of study activities with timely annual renewed approvals, supported the tracking of staff GCP certificates and populated timely notifications to investigators, resulting in submission of annual application packages on time.

RAIS has strengthened ethical regulatory compliance and provided an effective platform for tracking regulatory processes, thus enabled continuity of study activities with timely annual renewal approvals and greatly supported the tracking of staff GCP certificates.

The HTAi Vortal is a product of the HTAi Information Retrieval Group (IRG) which has collected resources in the field of Health Technology Assessment (HTA) since 2005.

In 2011, a new technical platform was set up and the legacy Vortal content was split in three sections: HTA producers and networks, Selected references and Career development (including trainings). The same year, a fourth section was created to host a new product of the IRG: SuRe.info.

In 2014, the Vortal added a new service to other Interest sub groups of HTAi: the hosting of “Custom bibliographies”. But while the Vortal was probably quite unique in 2005, other Websites have been developed since then to offer quite similar functionalities.

The present communication aims at evaluating how the Vortal compares with similar tools existing on the Web.

Vortal competitors have been identified using a quick empirical search of the Web.

Functionalities have been identified by testing the website or their archive; maintainers have been sometimes contacted to ask for complementary information. A grid listing all functionalities has been established and filled in with the collected information.

Several competitors have been identified. The Vortal presents functionalities similar to online tools, but detailing level is different. Also, the Vortal provides a better integration resulting in more efficiency. And, the Vortal is the only Web platform to offer a service of publication of custom bibliographies to the different HTAi Interest Sub Groups.

After 12 years of existence, the HTAi Vortal is still a recognized online resource about HTA. While some existing functionalities are to be found in other online tools, some remain unique to the Vortal. Further research is needed to evaluate the preferences of people with interest in HTA.