Human-centered approaches to eliciting requirements for medical equipment selection are recognized as improving healthcare outcomes, safety, and end-user satisfaction. Nevertheless, there are many challenges to conducting rigorous investigations to identify requirements that satisfy different hospital services and types of end users (e.g., patients, healthcare professionals, and clinical engineers). By establishing a systematic method for selecting medical recliners, this study provides detailed technical characteristics and user requirements associated with several hospital areas, as well as a comparison between two end users (health professionals and patients) and their different perceptions of usability.

First, clinical engineers and senior nurses from seven hospital services identified and rated the technical characteristics of medical recliners. Ratings were then used to stratify all services in well-defined similar groups using hierarchical and non-hierarchical clustering algorithms. Next, users of hospital recliners (60 patients and 56 healthcare providers) from each group were interviewed to identify their requirements for an ideal medical recliner. Finally, analyses of variance were performed to identify consensus decisions from users across the different hospital contexts as to which technical characteristics were the most relevant.

The contribution of senior nurses and clinical engineers led to the identification of 41 technical characteristics. The analysis of 116 participant interviews identified 95 different requirements, extracted from 1,052 user suggestions. Correspondence analysis of the most important requirements, combined for each of the three stratified service groups, indicated that two-thirds of all user requirements (14 out of 20) were fulfilled by five out of 32 quantitative technical characteristics, regardless of context.

Human-centered methods can identify similarities between health technology characteristics and decrease the complexity associated with selecting technologies, while simultaneously fulfilling the requirements of multiple users and hospital departments.

We sought to examine patients’ perceptions of disease burden and treatment impact, and what patients value over the course of the asthma experience.

Patient focus groups were conducted in three countries, the USA (n = 8 patients), the United Kingdom (n = 7 patients), and Germany (n = 7 patients), to examine aspects of disease burden and patient experience (physical, emotional, clinical, economic, and social). Cause and effect were also explored. Global Initiative for Asthma guidelines were used to screen patients by severity, based on age, sex, time since diagnosis, number of attacks, oral corticosteroid use, and number of therapies needed to control symptoms. Patients classified and ranked aspects of disease burden, including whether it was continuous or episodic in nature, and discussed the interventions used to manage their asthma.

The overall burden of illness was driven by the combined effect of the disease and treatment burdens. All patients highlighted the negative impact of oral corticosteroids. Patients believed that they were the key actors in their asthma management (not healthcare professionals), and reported the physical and emotional burdens as being the most dominant. Understanding of the terms “attack” or “exacerbation” differed significantly between patients, and did not necessarily match the clinical definitions. Patients considered asthma to be an individualized condition that drives lifestyle changes; disease management drives burden and vice versa. Patients perceived that burden was continuous over time, with specific phases of variable duration—before, during, and after an attack—whereas other stakeholders had a more episodic focus. Patients expected more holistic and personalized approaches for managing their asthma.

The research indicated a misalignment between what patients value and what clinicians, payers, and regulators consider in their assessments and decisions. Greater alignment among the different stakeholders, and more inclusion of patients’ values in decision making, will improve outcomes.

Previous qualitative research analyzing social media and online community discussions highlighted the symptomatic burden of cough and mucus (sputum), alongside shortness of breath, in patients with chronic obstructive pulmonary disease (COPD). The objective of this study was to determine the relative importance of these symptoms and their consequences (for example, disturbed sleep) to COPD patients, compared with conventional COPD endpoints (lung function and exacerbations).

A total of 1,050 patients (at least 40 years of age) with moderate to severe COPD or chronic bronchitis, and regular symptoms of cough and excess mucus production, are to be recruited through patient advocacy groups (PAGs) from five countries (Australia, France, Japan, the United Kingdom, and the United States; 150 to 400 patients per country). A discrete choice experiment was designed with input from clinical experts and the PAGs, plus scientific advice from the National Institute for Health and Care Excellence (NICE) in the United Kingdom. Patients’ preferences for the conditional relative importance of symptoms and impact of COPD will be quantified based on trade-offs they are willing to make among hypothetical COPD disease state profiles, described by differing attributes and levels. Hierarchical Bayesian analysis with effect-coding parameterization will be undertaken on the choice data to estimate (using Gibbs sampling) the relative value each respondent places on an attribute level.

The feedback from NICE informed the selection of screening criteria and the statistical analysis plan, as well as the inclusion of a health status measure, the EQ-5D-3L. Qualitative patient interviews and pilot testing of the attributes and levels grid have been completed, informing finalization of the online survey design.

Patient preference studies evaluating the relative importance of symptom burden through assessment of disease state preference values are an important new form of patient-based evidence for informing value-based decision making in HTA. The present study should facilitate a more patient-centered approach to developing new treatments for and improving the care of patients with COPD.

Malnutrition, specifically protein-energy wasting (PEW), is common in patients with chronic kidney disease (CKD), and its prevalence increases as CKD progresses. Oral nutritional supplementation (ONS) with complete formulas specific to this pathology, is a strategy aimed at meeting energy and protein requirements that are not possible with dietary recommendations and advice alone. This study systematically reviewed the available scientific literature on the safety and effectiveness of nutritional therapy with complete formulas specially designed for adults with CKD who have PEW that is not reversible through ordinary food consumption.

We systematically searched for articles published up to May 2018 in several electronic databases. We included comparative studies that evaluated the safety and effectiveness of complete nutritional formulas for malnourished adults with CKD. Relevant outcomes included rates of death, hospitalization, and adverse effects, and changes in nutritional status, anthropometrics, and health-related quality of life (HRQoL).

Three systematic reviews and 22 primary studies were identified. The primary studies comprised nine randomized controlled trials, nine non-randomized comparative studies, and four before-after studies (the latter were only included in the safety review). The majority of studies were conducted in patients on hemodialysis. The studies exhibited methodological heterogeneity in terms of the methods used to measure nutritional status and the interventions and comparators evaluated. There was also inconsistency among the results. Adherence to ONS, especially in the long term, can be affected by taste fatigue produced by repeatedly taking the same formula. Some studies recommend supplementation during hemodialysis sessions.

The studies with less risk of bias indicated a trend toward improvements in rates of death and hospitalization, HRQoL and, to a lesser extent, some anthropometric variables and serum markers, such as albumin, when ONS was given to patients with CKD. High quality comparative studies are needed to make conclusive statements about the effectiveness of this intervention.

Omalizumab and ciclosporin are recommended in international clinical guidelines for treating antihistamine-resistant chronic spontaneous urticaria (CSU). This meta-analysis aimed to evaluate their comparative efficacy and safety to inform local treatment practices in Singapore.

The PubMed and EMBASE databases were searched for randomized controlled trials (RCTs) published up to October 2018 involving omalizumab or ciclosporin as an add-on therapy to H1-antihistamines for CSU. Key outcomes were changes in weekly Urticaria Activity Score (UAS7), adverse events, and health-related quality of life. Pairwise meta-analysis was conducted for each outcome. Owing to differences in trial designs and patient characteristics across the studies, a random effects model was employed. In the absence of head-to-head trials, the Bucher method of adjusted indirect comparison was used to estimate the comparative effectiveness between omalizumab and ciclosporin, with placebo as the common comparator.

Eight omalizumab and two ciclosporin placebo-controlled RCTs comprising 1,740 patients were selected. The magnitude of treatment effect for omalizumab was dose-dependent across all efficacy outcomes: 300 mg was superior to 150 mg. Omalizumab 300 mg, although statistically significantly better than placebo for all efficacy outcomes at week 12, did not achieve clinical significance for all measures. The mean change in UAS7 was statistically better for ciclosporin than for placebo (one RCT) at week 4. The indirect comparison between omalizumab and ciclosporin showed no statistically significant differences for mean change in UAS7. Omalizumab had a more favorable short-term safety profile than ciclosporin, but long-term safety data were lacking.

Both omalizumab and ciclosporin were effective in treating CSU, compared with placebo. However, results of the indirect comparison should be interpreted with caution. On the basis of limited available evidence, and taking into account the similar place in therapy of omalizumab and ciclosporin, the results may be considered acceptable to confirm the clinical comparability of the drugs an add-on to H1-antihistamines for CSU.

Telediagnostic apps based on information and communication technology tools can be used to enhance community hospital response capacity. Evidence on how this innovative technology can improve health services is limited, but will likely expand in the new decade. The ability of different telediagnostic methods to enhance the response capacity of community hospitals in rural areas of Paraguay was investigated.

This descriptive study was carried out by the Telemedicine Unit of the Ministry of Public Health and Social Welfare, in collaboration with the Department of Biomedical Engineering and Imaging of the Health Science Research Institute and the University of the Basque Country, to evaluate the utility of telediagnostic apps for different disciplines in public health. The results from implementing telediagnosis apps in 60 public community hospitals across the country were analyzed and evaluated.

A total of 410,840 diagnoses were performed remotely between January 2014 and August 2018 across 60 rural community hospitals. The diagnoses involved computed tomography (147,627 or 36%), electrocardiography (256,422 or 62%), electroencephalography (6,772 or 2%), and ultrasound (19 or 0.01%). There were no significant differences between the remote and face-to-face diagnoses; remote diagnoses were correct in 93 percent of cases. Utilizing telediagnostic apps reduced costs, which is an important benefit for the 60 communities.

The results showed that telemedicine can significantly enhance the community hospital response capacity of diagnostic services and health programs, making optimal use of professional time and productivity, increasing access and equity, and reducing costs. However, before carrying out the systematic implementation of this technology, contextualization with the regional epidemiological profile must be performed.

Data exchange protection is one of the main challenges in e-health. Nowadays, many people move from one country to another for various reasons, even though they may have chronic diseases or multiple pathologies. The main objective of the SHIELD project is to create an open and extendable security architecture, with supported privacy mechanisms that citizens can trust, to provide systematic protection for the storage and exchange of health data across European borders.

epSOS is a European project that deals with the security and interoperability of e-health data, and has developed an Open National Contact Point (OpenNCP) architecture. For the initial validation of the framework, two OpenNCP virtual nodes were used to simulate the real nodes between Italy and Spain. For secure data exchange, different prototype tools were designed: end-to-end user interfaces (profiles for administrative staff, nurses, physicians, etc.); sensitivity and data hiding tools; consent management tools; report translation tools; and mobile device tampering detection tools.

Validation scenarios (realistic use cases) were developed in Italy, Spain, and the United Kingdom. The first scenario was an Italian citizen traveling to Spain who has an acute emergency episode (e.g. stroke) and loses consciousness. The Spanish emergency department physician assisting the patient checks the patient's health record. The first round of SHIELD framework validations was successfully completed, and the results were presented to the European Commission.

Security challenges need to be addressed when assessing e-health solutions. The challenges include issues with interoperability, confidentiality, availability, integrity, privacy, ethics, regulations, and e-health data. In addition, decisions must be made as to which data will be shared and how. The results of the initial validations provide a basis for the in-depth requirements analysis and for setting the main pillars of the SHIELD architecture design.

E-health and m-health are emerging health technology fields that could possibly give a new scope to health technology assessment (HTA). The Division for Health Technology Assessment (DfHTA) is currently assessing medicines and non-drug technologies (medical devices intended for patient use or for use in hospitals). The experience assessing medical devices for use in hospitals yielded difficulties which could also arise from the critical appraisal of e-health or m-health technologies. The objective of this study was to explore the foundations for HTA guidance on e-health or m-health technologies.

A targeted literature review was conducted to map the current status of technology assessment practices for e-health and m-health technologies and to assess its concordance with current reimbursement processes in countries belonging to the Organisation for Economic Co-operation and Development. Experiences from past evaluations of other medical devices that could not be evaluated under the current guidance guided the literature search. The findings of this research were used to create a recommendation to amend the current Hungarian Guideline for Health Economic Analyses.

The resulting articles of the targeted literature review provided an insight into current practices on of assessing e-health and m-health products, particularly with respect to the domains of safety, quality, and impact. Recommendations suggested including a list of requirements for companies to submit for critical evaluations of e-health and m-health technologies, in support of a self-assessment approach.

As for other HTA bodies, there is an urgent need for the DfHTA to increase its capacity to assess digital health technologies for entry into the healthcare system, with a focus on the relevant clinical domains. The reimbursement process for these technologies remains a challenge for public funding bodies.

There are enormous expectations for e-health solutions to support high quality healthcare services, with accessibility, and effectiveness as key goals. E-health encompasses a wide range of information and communication technologies applied to health care, and focuses on combining clinical activity, technical development, and political requirements. Hence, e-health solutions must be evaluated in relation to the desired goals, to justify the high costs of such solutions.

Health technology assessment (HTA) aims to produce rational decisions for purchasing new technologies and evaluating healthcare investments, like drugs and medical equipment, by measuring added value in relation to clinical effectiveness, safety, and cost effectiveness. It is desired to also apply HTA assessment on large scale e-health solutions, but traditional quantitative HTA methodology may not be applicable to complex e-health systems developed and implemented as ongoing processes over years. Systematic reviews and meta-analyses of these processes risk being outdated when published, therefore action research designed to work with complex, large scale programs may be a more suitable approach.

In the project, we followed the development of a new process-oriented electronic patient record system (EPR) in northern Norway. Part of the process was structuring clinical data to be used in electronic forms within the system. This was the first time a health region structured the clinical data and designed the forms; receiving feedback alongside the process was very important. The goal was to use structured forms as a basis for reusing EPR data within and between systems, and to enable clinical decision support.

After designing a prototype of a structured form, we wrote an assessment report focusing on designing a methodology for such development, which stakeholders to include, and how to divide the work between the health region and the system vendor. The answers to such questions will have both practical and economic consequences for designing the next phase of the process.

Astigmatism is a common ocular condition that causes reduced visual acuity. The condition is highly prevalent in cataract patients, with preoperative astigmatism of at least 0.5 diopters being present in 78 percent of cataractous eyes. Residual uncorrected astigmatism after cataract surgery is associated with significant costs, primarily driven by the lifetime cost of spectacles (estimated at EUR 1,608 to EUR 3,608 in Europe). Toric intraocular lenses (IOLs) are a safe and effective way of correcting astigmatism, while also reducing the need for spectacles after cataract surgery. The objective of this review was to assess the published evidence relating to spectacle independence in patients implanted with toric IOLs, compared with those receiving non-toric IOLs with or without astigmatism reducing surgical interventions (SI).

A systematic literature search was conducted of the EMBASE, MEDLINE, and Cochrane Library databases. Articles were selected if they included adult patients undergoing phacoemulsification who had age-related cataracts and preoperative regular corneal astigmatism of at least 0.5 diopters, and assessed spectacle independence as an outcome.

Seven studies met the inclusion criteria: four randomized controlled trials and one non-randomized comparative study comparing toric IOLs with non-toric IOLs, and two randomized controlled trials comparing toric IOLs with non-toric IOLs plus SI. Spectacle independence was evaluated as the number of patients who reported not requiring spectacles for distance viewing at 3 or 6 months. Figures for spectacle independence ranged from 60 to 100 percent for toric IOLs, 31 to 50 percent for non-toric IOLs, and 36 to 65 percent for non-toric IOLs plus SI. In each study, toric IOLs demonstrated superior spectacle independence compared with the control group.

The benefits of toric IOL implantation for astigmatic cataract patients included a higher rate of spectacle independence, compared with non-toric IOLs with or without SI. For this group of patients, the lifetime economic burden of spectacle acquisition costs can be reduced with the implantation of toric IOLs during cataract surgery.

The rise of antimicrobial resistance (AMR) as an international public health threat calls urgently for improved stewardship of antibiotics and for the development of new antibiotics to tackle AMR. There is growing agreement that changes are needed to existing systems for health technology assessment (HTA) and procurement if antibiotics are to be used appropriately, and manufacturers are to receive rewards that incentivize research and development. However, there has been little discussion of what changes might actually be made.

We conducted a literature review of recent proposals to modify HTA and contracting for antibiotics, and interviewed HTA experts from England, France, Germany, Italy, Japan, and Sweden to explore the attractiveness of these and other proposals in their countries. A forum (held in February 2019) with government and health system representatives from these countries, as well as from industry, will promote face-to-face discussions on practical ways to modify approaches in these countries to recognize the full value of antibiotics and promote responsible stewardship.

The focus of the main proposal is to define value attributes that reflect the societal impact of antibiotics, model the dynamics of infection transmission and resistance development, and conceptualize payment models that delink volumes sold from final revenues. However, HTA experts perceived a number of issues with these proposals, including a lack of data to demonstrate societal value, complex modeling techniques that require advanced capabilities, uncertain value estimates, and lack of alignment with current approaches. At present, it appears that only England and Sweden have started to actively address HTA and contracting for antibiotics as a priority.

Preliminary findings suggested that efforts and progress on modifying HTA and contracting of antibiotics have been heterogeneous so far. The forum will shed further light on possible ways forward within the two value assessment approaches of clinical added benefit and quality-adjusted life years.

Autism is a neurodevelopmental disorder characterized by alterations in the intellectual, social, communication, and behavioral capabilities of an individual, and is rarely detected in children before 24 months of age. Early diagnosis and intervention may be more effective at a younger age. Functional connectivity magnetic resonance imaging (fcMRI) of 6-month old infants may be able to identify brain connection patterns related to at least one of the characteristics of autism, which normally appear at 24 months of age, by using a mathematical model to analyze the neuroimaging data.

Clinical studies published up to December 2018 that used fcMRI to detect autism in infants were reviewed. The literature databases searched included PubMed, Web of Science, the Trip Database, DynaMed, the Cochrane Library, the International Clinical Trials Registry Platform, and ClinicalTrials.gov. Early assessments of fcMRI analysis were identified through the Early Awareness and Alert System of the Agencia de Evaluación de Tecnologías Sanitarias.

Only one prospective study of 59 infants at 6-months of age was retrieved. A fcMRI analysis was performed to identify 2,635 pairs of functional connections from 230 brain regions. The infants were subsequently assessed for autism at 24 months of age using gold standard tests. The functional connections correlated with at least one of the behaviors related to autism evaluated at 24 months of age. Eleven infants (19%) were diagnosed with autism at 24 months. Compared with the gold standard test results, the predictive model achieved the following: sensitivity 0.82 (95% confidence interval [CI]: 0.52 - 0.95); specificity 1.00 (95% CI: 0.93–1.00); positive predictive value 1.00 (95% CI: 0.70–1.00); negative predictive value 0.96 (95% CI: 0.87–0.99); and negative likelihood ratio 0.18 (95% CI: 0.05–0.64). Adverse effects were not reported in the study.

The fcMRI analysis could help in early detection of autism and the development of preventive interventions. However, the evidence is sparse and more well-designed studies are needed.

Conditional marketing authorization (CMA) and accelerated assessment (AA) have been introduced to expedite the development of and access to therapies in Europe. However, to reach patients medicines must also be publicly reimbursed. This research evaluated the reimbursement of therapies which have received European CMA or underwent AA.

Medicines that received CMA or underwent AA between January 2012 and December 2017 were identified. Appraisals of these medicines conducted by major European payer bodies were obtained from relevant websites and key data were extracted.

Out of the 38 medicines that received a CMA, 83 percent (19/23) were assessed by the National Institute for Health and Care Excellence (NICE) and received positive decisions, compared with 57 percent (16/26) by the Scottish Medicines Consortium (SMC) (defined as recommended/restricted), 74 percent (14/19) by Gemeinsamer Bundesausschuss (G-BA) (defined as any level of additional benefit), and 29 percent by Haute Autorité de Santé (HAS) (amélioration du service médical rendu I-III). The median delay between CMA approval and positive health technology assessment (HTA) outcome was 13 months for NICE, 11 months for SMC, 7 months for G-BA, and 5 months for HAS. Thirty-two medicines underwent AA. Of these, 68 percent (17/25) were appraised by G-BA and received positive outcomes, compared with 29 percent (7/24) by HAS, 90 percent (19/21) by SMC, and 86 percent (18/21) by NICE. The median delay between AA approval and positive HTA outcome was 7.4 months for G-BA, 7.9 months for HAS, 11.7 months for SMC, and 11.8 months for NICE.

CMA has expedited regulatory approval for products that address severe unmet needs. However, many of these products fail to gain public reimbursement, and even when they do there is a significant delay. AA provides market authorizations two months earlier than standard centralized assessment. Although high rates of positive payer outcomes have been achieved, the products typically experience substantial additional delays in securing public reimbursement. A parallel, cooperative approach among regulatory and HTA bodies across Europe is required to truly expedite patient access.

Effective communication is vital for engaging stakeholders in health technology assessment (HTA), as well as the successful dissemination and adoption of HTA research and guidance. As a relatively new organization, Health Technology Wales (HTW) has an ideal opportunity to take an effective, strategic approach to communication and stakeholder engagement from the outset.

HTW commissioned Pagoda Public Relations to develop an informed communications strategy and delivery framework. The strategy used OASIS methodology for public relations planning: Objectives, Audience insight, Strategy, Implementation, and Scoring (evaluation). Initial objectives were developed with input from the HTW team and members of the HTW Assessment Group and Appraisal Panel. Stakeholder insights were collected through an online survey and telephone interviews. These insights were used to inform the communications strategy and framework, outlining key audiences, key messages, communication objectives, methods, tactics, and evaluations.

Seven key objectives were identified, each of which were supported by recommended actions. These were underpinned by the key aims and messages reflecting how we will achieve these objectives. National Health Service boards, government, clinicians, the technology and research sector, patients, and the general public were identified as priority audiences. Various different communication channels and activities were identified, aimed at various audiences. These included the website, social media, traditional media, and exhibitions or workshops, as well as targeted e-mail dissemination of guidance. Evaluation of HTW communications will be aligned with the wider HTW evaluation strategy, and evidence will be recorded through OutNav software (Matter of Focus Ltd).

HTW is committed to a strategic, effective approach to communication and engagement. We now have an audience-informed communications strategy and plan that outlines our key objectives, and how to achieve and evaluate these objectives. Successful implementation will raise awareness of and value in profile and outputs of HTW, both in Wales and internationally.

Wales has ambitious health, wealth, and innovation policies and a clear goal to use the economic muscle of the Welsh National Health Service (NHS) to support its strong life sciences sector. Health Technology Wales (HTW) has a clear remit to appraise technologies over the span of their lifecycle from innovation to obsolescence. HTW is collaborating with the Bevan Commission through their national Health Technology Exemplars (HTEs), which partners NHS and industry stakeholders to strengthen innovation within the Welsh health system.

Health technology assessment (HTA) methods were used to produce topic exploration reports for assessing the evidence underpinning applicant innovations. A “Dragons’ Den” expert panel was convened to select the successful HTEs.

Fourteen Bevan HTEs were awarded funds, which were matched by industry partners. Application of HTA methods resulted in more critical consideration of technology value propositions, including: developing pull models of innovation focused on delivering health technology solutions for current problems facing NHS Wales; supporting early dialogue between the NHS and industry partners around demonstrating evidence of improved patient outcomes; and focusing on transformative rather than incremental innovation. The most promising innovations will progress to rapid HTA, where the evidence generated will be used to develop guidance for NHS Wales.

HTA methods were productively deployed at the innovation phase of the technology lifecycle to support evidence-informed allocation of scarce innovation resources. In this way, HTW is working with key stakeholders to identify and offer early support to the most promising innovations, with the aim of expediting their adoption and realizing health benefits for patients as quickly as possible. The Bevan Commission has partnered with HTW to routinely build in HTA and evidence considerations in its future innovation calls and competitions. Thus, HTW has established a “feeder” pipeline for assessing bottom-up service-led innovations and encouraging evidence consideration throughout the lifecycle of innovative technologies.

Health Technology Wales (HTW) is a relatively new Health Technology Assessment (HTA) agency which focuses on non-medicines. In common with other HTA organizations, it identifies and appraises a range of technologies. However, HTW is also looking beyond the publication of guidance, to assess the adoption of advice and its eventual impact.

HTW commissioned development of an Evaluation Plan from independent experts (Matter of Focus). A literature review was carried out to inform an options appraisal of methods for assessing impact. The selected approach was Contribution Analysis, which estimates the counterfactual through engagement of stakeholders.

Whilst it is too early to report the full impact of HTW's guidance, a number of activities have taken place to prepare for evaluation. The core HTW team developed a series of logic models to describe the anticipated impact, the mechanisms by which it would be achieved, and key assumptions. Stakeholders were consulted for insight from a range of perspectives, and to manage expectations. This was achieved through individual interviews, presentation and discussion at committee meetings, and the sharing of written materials for feedback. This information was collated to populate bespoke software (OutNav). The collection of data relating to processes, outputs and outcomes is already an ongoing routine task of researchers and support staff.

HTW has an opportunity to build impact evaluation into its culture from the beginning. This will facilitate the future reporting of HTW's influence using a well-designed, evidence-based approach. Furthermore, this pioneering work will clearly demonstrate the value of HTA to funders, commissioners, governments, and other decision-making bodies.

The re-organization of the supply chain (SC) of medicines and medical devices may improve the efficacy and efficiency of the National Health Service (NHS). The aims of this study were to (i) identify the offers provided by private operators to NHS, and (ii) analyze the organizational model of the public healthcare SC system and its criticalities.

Two online surveys have been designed. Regarding the first survey, managers of private providers associated with the National Association of Commercial and Logistic Operators (ASSORAM) have been interviewed to identify the offers provided to the NHS. The second has been submitted to managers of local health authorities and university hospitals associated to the Italian Association of Hospitals (FIASO) to gather both organizational/managerial information (warehouse capacity, purchasing, registry, security) and qualitative aspects of the SC. Data was collected in 2015.

On the supply side, 41 providers have been interviewed. More than 70 percent of associates managed mainly hospital products; 67 percent of interviewees delivered less than 30 percent of products to hospitals, and only eight percent delivered about 70 percent of the products to hospitals. The providers’ infrastructure (warehouses, transport, information technology, cold chain, gross domestic product) were adequately regulated and they adopted a wide list of indicators for monitoring performance. Private providers showed high interest in investing in the hospital sector. On the demand side (56 hospitals from 28 regions) the main weaknesses of SC are related to infrastructure, information technology, human resources, a lack of financial resources and inadequate process control.

The study highlighted extremely limited outsourcing in the hospital field to date, weaknesses in the public system and a high interest of private providers in investing in public hospital SC.

Since 2005, new treatment and diagnostic methods (NUBs) were reimbursed by individual supplementary fees. The assessment procedure for NUBs is induced by hospitals submitting a request for additional compensation of healthcare treatment to the Institute for the Fee System in the Hospital (InEK). In 2016, the legal norm §137h SGB V was introduced to evaluate medical devices (MD) of high risk classes by the Federal Joint Committee (G-BA). InEK grants a status that is valid for twelve months and impacts additional compensation as well as assessment required by G-BA. The effects of this rating seem to differ between hospitals and Statutory Health Insurance (SHI).

The published InEK decisions on NUBs were analyzed according the decision criteria and possible impact on price negotiations with SHI.

In 2018, 705 NUB requests were assessed by InEK. NUB Status 1, granting negotiation of additional coverage, was assigned to 171 procedures. Status 2 – no additional reimbursement possible - was given in 472 cases, the remaining had not sufficient information. Most NUBs (n = 368) requests did not fall under §137h; however, those with sub-Status “B” (allocated to 12) led to controversies; no participant had requested an evaluation according to §137h for the NUB. Two consultation requests receiving Status 1 B were regarded as not eligible according to § 137h by the G-BA. To avoid price negotiation delays, early consultations according to § 137h are recommended by G-BA during the NUB application.

The NUB process enables hospitals to receive a supplemental payment when using innovative technologies not listed in the existing German healthcare system. The question of which requirements must be fulfilled to guarantee the reimbursement should be asked at an early stage. Consultation requests to the G-BA in due time are strongly recommended. Contact between manufacturers and hospitals are advisable to support the NUB application.

Due to an aging population, shortage of healthcare staff, and escalating healthcare costs, there has been a recent shift in the professional roles and responsibilities in acute care settings to help bridge the care gap. Paramedics, whose primary responsibilities have been in emergency/transportation services, are increasingly involved in the management of chronic diseases in the community setting. However, even with additional training, there are concerns about the safety and effectiveness of this expanded role. The objective of this presentation is to highlight some of the key findings from a health technology assessment report on the safety and effectiveness of community paramedicine in assessing and managing conditions/diseases with low acuity.

A systematic review was conducted to identify studies that evaluated the safety and effectiveness of different community paramedicine programs.

Four systematic reviews and 20 primary studies (one randomized controlled trial (RCT) and 19 observational studies) were identified. Of these, two systematic reviews and 14 primary studies focused on the safety and effectiveness of Emergency Care Practitioner (ECP) programs ̶ widely implemented programs whereby a paramedic or nurse undertakes activities traditionally performed by physicians, such as the initial assessment of patients, provision of simple treatment, or referral of patients to other clinical care. Limited evidence showed that ECP programs are promising in reducing repeated emergency calls, emergency department visits, hospital admissions/readmissions, and emergency transport charges. While the majority of included studies did not report any safety outcomes, no significant safety issues were identified from the cluster RCT. Evidence for other types of community paramedicine is limited.

Evaluation of the impact of community paramedicine programs remains methodologically challenging. Additional cluster RCTs may help determine the effectiveness of community paramedicine programs; safety outcomes should be a key element of future observational studies.

Current clinical practice is based on guidelines and local protocols that are informed by clinical evidence. This means that clinical variability is reduced, but can lead to inefficient clinical decision-making, and can increase medical errors, decreasing patient's safety. The aim of the EXCON project is to investigate the innovative concept of Intelligent Clinical History (ICH), and to develop functional prototypes of high added-value in healthcare services.

The innovative EXCON project will take advantage of recent advances in technologies for coding, structuring and semantizing medical information. Thanks to this new structuring, the EXCON platform will be developed. Final users will be health professionals and other decision-makers. Doctors, nurses, epidemiologists and information specialists will be involved in the development and subsequent validation of the platforms.

To develop the ICH platform clinical data on a highly prevalent symptom with high variability in clinical practice, such as non-traumatic chest pain in emergency services, has been collected from different electronic medical record databases. The extraction of clinical data to implement new techniques of artificial intelligence requires tasks that must be automated, which today is difficult and tedious (data is often not computerized). Through techniques applied in EXCON, such as natural language processing, relevant clinical data have been extracted and a Decision Support System has been developed and validated. This tool optimizes resources and improves clinical management, reducing errors and increasing patient's safety.

In coming decades, patient management will be impacted by the application of new advanced data analytics tools. This will allow for safer and more efficient clinical management, decrease variability in clinical practice, and improve equity. That is why the development and assessment of these technologies is necessary.