Recruitment of participants and their retention in randomized controlled trials (RCTs) is key for research efficiency. However, for many trials, recruiting and retaining participants meeting the eligible criteria is extremely challenging. Digital tools are increasingly being used to identify, recruit and retain participants. While these tools are being used, there is a lack of quality evidence to determine their value in trial recruitment.

The aim of the main study was to identify the benefits and characteristics of innovative digital recruitment and retention tools for more efficient conduct of RCTs. Here we report on the qualitative data collected on the characteristics of digital tools required by trialists, research participants, primary care staff, research funders and Clinical Trials Units (CTUs) to judge them useful. A purposive sampling strategy was used to identify 16 participants from five stakeholder groups. A theoretical framework was informed from results of a survey with UKCRC registered CTUs. Semi-structured interviews were conducted and analysed using an inductive approach. A content and thematic analysis was used to explore the stakeholder's viewpoint and the value of digital tools.

The content analysis revealed that ‘barriers / challenges ‘ and ‘awareness of evidence’ were the most commonly discussed areas. Three key emergent themes were present across all groups: ‘security and legitimacy of information’, ‘inclusivity’, and ‘availability of human interaction’. Other themes focused on the engagement of stakeholders in their use and adoption of digital technology to enhance the recruitment/retention process. We also noted some interesting similarities and differences between practitioner and participant groups.

The key emergent themes clearly demonstrate the use of digital technology in the recruitment and retention of participants in trials. The challenge, however, is using these existing tools without sufficient evidence to support the usefulness compared to traditional techniques. This raises important questions around the potential value for future research.

The Evelina London Children's Hospital (ELCH) is undergoing a period of growth, including a new building planned to be completed within the next five years. Due to limited space and ambitions to be a state-of-the-art hospital, Horizon Scanning (HS) was considered important to ‘future-proof’ new facilities. As the aim of HS is to identify signals of coming change, ‘scanning’ the previous five years’ trends may be beneficial to an iterative HS methodology. Thus, it was thought that capital bids could provide a range of useful information required to make procurement decisions.

King's Technology Evaluation Centre (KiTEC) provided hospital-based HTA and HS support for the expansion of a London-based paediatric hospital. KiTEC focused on imaging technology due to its large spatial requirements and high-costs and assessed all capital bids made over the previous five years. A capital bidding system is used within GSTT to allocate funding for medical equipment that costs more than GBP5000 (USD 6540.70). Information was collated for all imaging equipment bid for over the previous five years and assessed for trends in imaging modalities and purchase costs.

A total of 135 bids were made in the period 2013-2018, eight of which were by ECLH. Bids for ultrasound equipment were most common and rose over the period. Bids for CT scanners also rose, while bids for MRI scanners and x-ray technology were consistent and bids for fluoroscopy fell. The total cost of imaging bids over the interval rose steadily from GBP5.4 million to GBP6.9 million.

Due to the lifespan of imaging technology, some trends may not emerge within a five year window. While some interesting findings were made, a ten to fifteen year period may require to be scanned for a robust analysis. This methodology is best applied in an iterative fashion along with standard HS techniques.

The MedicineWise app is a free consumer health and medicine management app developed by NPS MedicineWise. With 107,000+ downloads and 78,000+ active sessions per month, the MedicineWise app's core functions include: keeping track current medicines lists, medicine dose reminders and recording health conditions, allergies, test results and other health information. Recent enhancements also enabled the app to deliver featured health- and medicine-related content to users based on their medicines and/or health conditions. The goal is to maximise the MedicineWise app's capabilities by personalizing to users’ needs and combining with health professional interventions when needed, to encourage better delivery of health and medicines information and improve medication adherence and health outcomes.

A number of personalized medicines management service offerings were created by combining a technology solution using the MedicineWise app (including the app's core functions as well as added targeted content delivery capability) with a humanistic solution (a health professional-mediated phone-based coaching service). MedicineWise app features were developed iteratively using a human-centred design approach. Consumers were involved in the design, prototyping and testing stages before the features moved to technical-build stage.

Three use-cases will be presented to demonstrate how the MedicineWise app was used to provide personalized medicines management service offerings. These include: (1) curating relevant content and delivering push notifications to users for health conditions including asthma, rheumatoid arthritis and osteoporosis; (2) providing a triaged medication adherence support program with escalating levels of intervention for heart failure patients; and (3) collecting user-reported medication usage data and data monitoring by health professionals to provide support for heart failure patients.

The utility of MedicineWise app can be extended to provide personalized medicines management service offerings in the consumer health care space.

The CarbonCool full body suit is a portable, non-invasive core body cooling system for use by first responders and clinicians for targeted temperature management and heat stroke treatment. It uses pads made of a highly thermal conductive carbon-based cooling medium to absorb heat from the body. Our department was requested to review the effectiveness of the suit and whether it might be used in place of a Body Cooling Unit (BCU).

A rapid review was carried out on the technology. The PICO elements were: Population- Emergency department patients with exertional heat injury; Intervention- CarbonCool full body suit; Comparator- Body Cooling Unit; Outcomes- Adverse effects, clinical outcomes (survival, neurological status), physical measures (rate of cooling). The NHS Centre for Reviews & Dissemination databases, Cochrane Database of Systematic Reviews, PubMed (MEDLINE) and the US National Guidelines Clearinghouse were searched for systematic reviews, HTA reports and clinical practice guidelines. The importer was contacted to provide supporting studies for their product.

No publications were found on CarbonCool products. The importer provided the unpublished abstract of a retrospective cohort study of 124 post-cardiac arrest patients requiring targeted temperature management. The importer advised that a trial on pre-hospital heat stroke was pending. The full body suit is not intended as a replacement for body cooling units. Three clinical practice guidelines on management of heat injuries did not mention such cooling systems, but did recommend ice packs as a treatment option.

The CarbonCool Full Body Suit is not intended as a replacement for a Body Cooling Unit. No published studies were found showing effectiveness for managing exertional heat injuries. A trial on pre-hospital heat stroke was pending. Guidelines on managing heat injuries do not mention the use of the technology. It was recommended to await results of pending trials, or to use it only under research.

Good quality management (QM) and the sound application of EUnetHTA's (European network for Health Technology Assessment) well-established methodology and tools are fundamental prerequisites for reliable and trustworthy joint work. To provide ultimate support and guidance to the assessment teams of EUnetHTA – and further, to ensure a sustainable mode of work for the post-2020 period – a comprehensive web-based so called “EUnetHTA Companion Guide” is established in Joint Action 3.

The Companion Guide was created using the open source Wiki software “DokuWiki”. We divided the content into five main parts: 1. EUnetHTA's QM concept, 2. QM for rapid Relative Effectiveness Assessment (REA) Pharma, 3. QM for rapid REA Other Technologies (OT) 4. Scientific Guidance & Tools and 5. QMS-related training material. The assessment processes for rapid REA Pharma and OT have been subdivided into single process steps for which the Companion Guide provides standard operating procedures (SOPs), checklists, templates, guidelines and tools. The content of the Companion Guide is continuously subjected to evaluation by means of a structured survey with regard to the achievement of its purpose of ensuring to ensure high-quality HTA reports.

In May 2018, the Companion Guide was launched and is now available to all EUnetHTA partners. It provides central access to all components of the newly established QMquality management system for EUnetHTA. The user has access to training modules that provide information on how to use the Companion Guide. Moreover, the training material enables EUnetHTA partners to build up necessary capabilities for QMquality management, and application of methodologies and tools in the context of EUnetHTA.

The purpose of the Companion Guide is to ensure the production of high-quality HTA reports by providing ultimate support and guidance to the EUnetHTA assessment teams during their joint work. The continuous evaluation will reveal necessary revisions and the need for further developments and guidance.

The European Network for Health Technology Assessment (EUnetHTA) Planned and Ongoing Projects (POP) database allows sharing information on projects of HTA organisations participating in EUnetHTA. It enables users identifying overlaps and therefore has the potential to reduce duplication of work on similar topics. The aim of our research was to examine the usage of the database, how it helps to reduce duplication, and identify challenges to be addressed.

We conducted a systematic data collection and analysis on the topic overlaps retrospectively and complemented it with an electronic survey aimed at database users. The dataset on the overlaps was collected between June 2016 and September 2017. The survey was conducted in October 2017.

During the data collection period, the POP database contained on average 800 projects provided by around fifty percent of the EUnetHTA partner organisations. One hundred and sixty nine identical projects could be identified from which ninety-two percent had different starting dates. Twenty-five percent of the identical projects were elaborated on by three organisations, 10 percent by four, and 6.5 percent by five organisations. Analysis of the survey showed a pattern of “wait and see”: users are informed about what other EUnetHTA partners are working on, wait for a finalised HTA or exchange the project plan, search strategies, search results, extraction tables, etc. The data collection and survey could not provide a precise number of collaborations initiated based on information gathered from the database.

The POP database is suitable for information sharing and has the potential to save time and resources at EUnetHTA partners. The collaboration is hindered by differences in national processes, including the timing and scope of the assessments. The impact of the POP database on the facilitation of collaboration and reduction of duplication of HTAs produced by EUnetHTA partners is yet to be strengthened.

Health Technology Assessment (HTA) should continue evolving in order to effectively meet stakeholder expectations in the next decade. There is need for strengthening current expertise while developing new capabilities to keep up with rapid innovations in health care. Institutionalizing knowledge and skill through professionalization of HTA is a critical factor for successful “smart capability building” and the practice of HTA beyond 2020.

Professionalism is understood to mean different things by different people. This paper does not primarily focus on whether HTA is or should be a “profession” but on the development of institutions, structures, and attitudes that are characteristic of a profession and the impact they could have on the practice of knowledge and skill in HTA. “Professionalization” is used in this case to refer to the status of institutions, structures and attitudes and the process of establishing them. Professional standards include both ethical standards and standards of (technical) competence. Ethics applies to standards of competence, because stakeholders expect professionals to adhere to standards of competence and ethical standards. I will argue for the institutionalization of the practice of HTA knowledge and skill for mutual benefit and the prevention of exploitative and unjust use of HTA capabilities and processes. Is expertise necessary in HTA? Yes, conducting HTA requires specialized skills and knowledge. Effective decision-support requires multidisciplinary and efficient HTA teams. Core competencies and smart capabilities must be clearly defined and institutionalized for the production of effective HTA in the coming decade. Credentialism also becomes necessary for protecting the public from the consequences of bad evidence and bad choices. It will also protect the integrity of HTA practitioners and bolster professional autonomy.

Professionalization is instrumental in the development of ethical standards and standards of technical competence necessary for successful HTA practice.

HTAi should professionalize HTA to facilitate and guide “smart capability building”.

Professionals dealing with children with Neurodevelopmental Disorders (NDDs) need to be constantly trained because of the numerous challenges posed by the particularities arising from the multiple conditions that pervade child development. The aim of this study is to describe the training processes of education, health and social care professionals who care for children aged 0 to 12 years with neurodevelopmental disorders.

The revision overview was registered in the PROSPERO platform CRD42018100715 that followed the parameters of the PRISMA protocol and aimed to identify the existing multi-professional training processes, aimed at health professionals, education and social assistance aimed at promoting skills for care with children and families with TND. The research question was structured according to the acronym PICO. The search was performed in PubMed, Embase, Cochrane Library, CRD, Web of Science, Campbell Library, Health System Evidence, Epistemonikos and Joanna Briggs databases in May 2018.

We selected 23 articles. Of these, 21 (91 percent) were health professionals, 22 (96 percent) referred to intellectual disability, 16 (71 percent) were in the American continent and 15 (65 percent) used in-service training as educational resource. The outcomes showed that the structuring of teaching-learning in the practice of health, education and social care professionals determines a more inclusive proposal in the treatment of children with NDD.

The health professional is the most trained to attend children with NDD, however, training and development policies are lacking for professionals from other areas who act as a gateway to diagnostic services. Establishing in-service training initiatives strengthens the support and structuring of intersectoral programs that would facilitate multi-professional participation in the prognosis and treatment directed at children with NDD. Therefore, associating the use of assistive technologies allows new opportunities to access tools and electronic devices that allow the formation of professionals.

The elevated costs with biologic products threaten the sustainability of health services, and, therefore, the access to these medicines in the perspectives of user, health professional, health manager and system. The entry of biosimilar products in the market could be an option to subsidize the search for solutions to those problems.

We conducted a rapid review using the databases Medline (via PubMed), EMBASE, Cochrane Library and CRD. The eligibility criteria were HTAs, systematic reviews and cross-sectional studies.

Literature search retrieved 640 registries and, after duplicate removal, screening of titles and abstracts and full text reading, nine cross-sectional studies were selected. From a user's point of view, the following barriers were identified: lack of knowledge about the medicine, distance between the place of living and the health service (especially in the rural area), long waiting periods for service, passivity in regard to treatment. From a health professional's point of view the barriers were: acceptability of the expert in regard to treatment, interchangeability and substitution, the perception of lack of data showing efficacy and safety. Finally, from the payer's (or health manager) point of view, the barriers were: high cost of medicine, problems with reimbursement and bureaucracy. We did not retrieve any barriers from the health system's perspective from the selected studies.

The entry of biosimilar medicines in the market can induce competition and, therefore, reduce prices of biologic treatments. It is necessary to search for potential solutions to the access barriers identified in this rapid review.

In France, drug assessment is performed by the Transparency Committee (TC) of the French National Authority for Health (HAS). It's based on two criteria: the clinical benefit (CB) for reimbursement recommendation and the clinical added value (CAV) serving the pricing decision. The CAV is rated on a 5-point scale, from I (major) to V (no CAV). A critical step in the CAV assessment is the identification of the clinically relevant comparators (CRC) serving the TC to recognize the appropriateness of the comparators chosen in the randomized controlled trials (RCT). The objective of this study is to investigate the comparator choice consequences on TC appraisals and pricing.

A retrospective, descriptive study included all oncology indications assessed by the TC between 2015 and 2017. Based on a pre-specified grid, items on the comparators were extracted from final TC's appraisals.

Among the 135 indications included, the assessed drugs had no CRC in 20% of cases. A RCT was submitted for 89 indications (66%) whose 67 (76%) were conducted versus a CRC. A CRC was identified by the TC for 70% of the 46 indications without RCT. An important/moderate CAV (II-III) was granted when there was a RCT versus a CRC in 70% of cases, versus 50% and 43% for minor (IV) and no CAV respectively. The public price was reduced by 13.5% in average compared to the claimed price without impact of the CAV level (n = 18).

In oncology, comparative data assessed by the TC met its expectations (RCT versus CRC) in a majority of cases. When there is no RCT or a comparison versus a non-relevant comparator the CAV appraisal is decreased. Surprisingly this study hasn't shown any impact of this decrease on the public price. A wider analysis in different medical areas would need to be performed to better investigate these results.

Orphan legislations over the past thirty years have successfully increased the number of drugs receiving marketing authorization for rare diseases. However, for a therapy to be accessible to most patients, it requires not only marketing authorization, but market access via public reimbursement. In many major markets, the pricing and reimbursement of new therapies is based on an assessment by a national Health Technology Assessment (HTA) body, for which economic value is typically a key consideration. This research evaluates the outcome of HTAs of orphan drugs in Europe.

HTA decision data (to 31/08/2017) was extracted from Gemeinsame Bundesausschuss (G-BA), Haute Autorité de Santé (HAS), National Institute for Health and Care Excellence (NICE), Pharmaceutical Benefits Advisory Committee (PBAC), and Scottish Medicines Consortium (SMC) websites. EC-approval data was extracted from the European Medicines Agency (to 31/08/2017).

Only a small minority of drugs for orphan diseases received full recommendations for their licensed indication(s) by NICE (3/35, 9%), SMC (8/66, 12%) and PBAC (1/44, 2%). 37% (26/70) of drugs assessed received positive HTA outcome by HAS (ASMR I-III). In Germany, all approved orphan drugs (100/100) received automatic additional benefit post regulatory approval by G-BA.

There have been significant challenges for manufacturers in converting regulatory approval of orphan drugs into commercial success and optimised market access. Attaining positive HTA appraisals for these drugs, which have been approved under expedited regulatory pathways on a less than fully mature dataset, whilst also having high prices, due to small patient populations, limiting commercial returns, may necessitate increased utilisation of alternative reimbursement mechanisms.

Medicines for very rare conditions present challenges for healthcare globally due to uncertain evidence and often extremely high costs. In 2014, SMC introduced an ultra-orphan framework placing less emphasis on the cost per quality adjusted life year (QALY). Despite this, many medicines continued to be not recommended. A new pathway aimed at improved patient access based on further evidence collection is now being implemented.

The development of the new pathway has involved collaboration with key stakeholders including patient groups, the pharmaceutical industry, and clinicians. Medicines that meet a new definition (based on four criteria including the prevalence of the condition treated) will be appraised by the SMC committee and a data collection plan will then be agreed with the pharmaceutical company.

From April 2019, medicines validated as ultra-orphans will initially be appraised using the broader decision-making framework and the SMC committee will outline key uncertainties in the clinical effectiveness. The medicine will then be available for a period of at least three years while further data are gathered, potentially comprising ongoing clinical trials, registry data, and patient reported outcome measures. SMC will then re-assess the clinical and economic evidence to inform a final decision on routine use of the medicine in NHS Scotland.

The new pathway for ultra-orphan medicines will allow further evidence on their longer-term clinical benefits to be collected before a final decision on routine use. This approach reflects the current direction of travel in medicines regulation, by making medicines that address an unmet need available to patients at an earlier stage of development.

Applicability of incremental cost-effectiveness ratios from another jurisdiction is often affected by a different local discount rate, creating uncertainty about the ICER using the local discount rate. The ICER is sometimes reported at additional discount rates in the sensitivity analysis. We aimed to investigate the extent to which an ICER can be predicted at a given non-differential discount rate if estimates are available for at least two discount rates.

We used six previously published economic models representing analyses with a range of time horizons and ICERs calculated at discount rates from 1% to 8%. A simulation exercise was applied whereby the ICER at a discount rate selected from the range 2% to 5% was calculated based on ICERs provided at two or three randomly selected discount rates. With two discount rates a linear model was used to predict the ICER at the selected rate. For three discount rates an exponential model was used. Error between the predicted and actual ICER was calculated as the absolute difference divided by the actual ICER.

For four of the models, ICERs could be well predicted by a linear model (i.e., with two points), with average errors of less than 5%. For the final two models the error was substantial with a linear model but substantially improved to under 15% with an exponential model (i.e., with three data points). The two models with a poor fit to a linear model assessed childhood vaccination programmes over a lifetime horizon.

For studies with a relatively short time-horizon, or where the majority of costs and benefits accrue in the short-term, a simple linear extrapolation can facilitate calculation of the ICER at a discount rate other than those reported. With longer time horizons, a third data point facilitates more reliably extrapolation of ICERs at desired discount rates.

Evidence synthesis (ES) is often required for economic evaluation (EE) of pharmaceuticals. Commonly used methods are based on the assumption of proportional hazards in trial data, using the hazard ratio (HR). Alternative methods for ES are increasingly used in EE, in situations where the pattern of hazards in the trial data indicates that the proportional hazards assumption may be violated. The impact of these methodological choices on model outcomes is explored.

A network of trials of BRAF-targeted treatments for advanced melanoma, derived using a systematic review of the literature, is chosen for the study. Guyot's method is used to create individual-patient Kaplan-Meier (K-M) data from published survival curves. Log-cumulative hazard plots and Schoenfeld residuals are derived to examine patterns in hazards within the trial data. All analyses are conducted in R version 3.5.0©. Three alternative methods for ES are tested: 1) Network meta-analysis (NMA) based on published HRs and the assumption of proportional hazards. 2) NMA using fractional polynomials (FP) based on digitised K-M data, allowing the relaxation of the proportional hazards assumption. 3) NMA using an accelerated failure time (AFT) model based on digitised K-M data, allowing the relaxation of the proportional hazards assumption. The derived estimates of relative efficacy from each method are applied in a partitioned survival cost-effectiveness model programmed in Microsoft Excel™.

The model outcomes predicted by each method (HR, FP and AFT) are presented and compared. Both deterministic and probabilistic results are presented, alongside a discussion around how the uncertainty in these structural assumptions may be captured in EE.

Structural assumptions in ES may lead to differences in model outcomes. The impact of these differences may be important in situations where decision uncertainty is high. Methods should be chosen and justified based on patterns of hazard present in the trial data.

Despite increased healthcare systems costs, limited opportunities for health economics training are available to healthcare professionals. From 2016-2018, with a grant from the Brazilian Ministry of Health, the Federal University of Goias with 7 other universities, implemented the distance learning Postgraduate Certificate in Health Economics for Health Care Professionals (PCHE) aimed at enhancing technical capacity of professionals working in the Brazilian Public Healthcare System (SUS).

This is a descriptive and qualitative assessment of the PCHE implemented in Brazil 88 healthcare professionals working in SUS and involved in decision making in all levels of managament were enrolled in a health economics training, through long-distance learning strategy. We present course metrics, describe its workload, content, modalities and structure of training.

PCHE was structured with 3-day workshops introducing each of the modules, during which students were also evaluated regarding the previous module content. With a total workload of 360 hours, structured in four modules: Public Health and Epidemiology; Introduction to health economics and healthcare funding; Management of healthcare resources; and Healthcare economic evaluation. The module coordinator was resposible for supervision of course materials development, workshop, distance based tutoring activities, and evaluation. Course material included theorethical content and practical tools for economic evaluation and health technology assessment in the workplace, applying problem-based learning strategies. Certificates were granted to students with 75 percent presence and approved in all modules, and final papers approved by an examination board. Each module was completed in 8 weeks (90 hours/module). Within groups of 20 students, tutors performed communication witn chats twice weekly and discussion forums by topic.. A total of 88 students were enrolled. Drop-out rate was 35.2 percent (n = 31). Additional 10 students did not pass the exams. In total, 47 students completed the training.

Health economics training through distance learning is a more efficient use of resources with good results.

There is increased recognition of the need to include equity considerations in HTA. Despite this, a recent World Health Organization report has found that this is seldom the case. We developed a preliminary version of an equity checklist in the hopes that tangible guidance will increase such analyses in the future and contribute to smart capability building.

The checklist is based on the Equity Framework for HTA developed by Culyer & Bombard (2012). The elements presented in the framework were revised to follow the stepwise HTA process. A comprehensive literature search was used to update and complete the elements. The checklist was then piloted in an HTA in 2018 and subsequently further refined through a workshop during a national HTA conference in Canada.

These steps resulted in a 27-item checklist leading to consider different aspects of the three major phases in the HTA process. The scoping phase brings questions relative to defining and contextualizing equity, such as highlighting potential minority groups and including vulnerability factors in the logic model. The development phase leads methodological approaches facilitating the analysis of inequities as well as considering contextual realities leading to inequities. The last phase, drafting of recommendations, aims to be aware of the evidence synthesis approaches as well as the various aspects to ensure recommendations consider existing inequities and avoid contributing to their development.

Given the essence of HTA to protect health by ensuring optimal technologies and interventions are adopted to the benefit of all system users, the consideration of inequities should constitute an integral part of its process. The use of a pragmatic and simple checklist to aid the planning of an HTA could contribute to greater consideration of inequities in the future. A movement in this direction could also lead to greater methodological developments for health equity analysis in HTA.

Matching adjusted indirect comparison (MAIC) methods are extremely useful when conducting ITCs, as they reduce baseline imbalances between studies, particularly upon patient characteristics that are confounded with treatment. The standard approach when conducting MAIC is that proposed by Signorovitch et al. (2010). However, there are newer, and potentially better, methods available.

Three different MAIC methods (Signorovitch, Entropy Balancing, Polynomial Weighting) were compared using multiple phase 3 RCTs conducted in Diabetic Retinal Edema. The matching ability of each method was assessed, alongside its ability to avoid large weights (i.e. avoiding high leverage), and maximise effective same size (ESS). Each method's overall ease of use and impact upon estimates of treatment effectiveness were also evaluated.

All methods were able to precisely match the aggregate level data. However, the Entropy Balancing and Polynomial Weighting both outperformed the Signorovitch method in terms of having the lowest maximum weights. The Polynomial Weighting provided the highest ESS. The Entropy Balancing method was arguably the most challenging to implement, whilst the Signorovitch method the least. The Polynomial Weighting method appears to provide the greatest flexibility to the user.

Whilst the Signorovitch method has become almost synonymous with MAIC, the Entropy Balancing and Polynomial Weighting methods offer potentially superior performance. In the absence of head-to-head trial data, these new MAIC approaches should provide less biased and more precise estimates of comparative effectiveness – ultimately leading to better decision making by regulators and payers.

The Stride Management Assist (SMA®) device consist in a portable robotic exoskeleton designed for gait rehabilitation and training by repetition of walking patterns with automated regular gait cycles. Used for adult population with gait disorders of neurological or musculoskeletal origin that require rehabilitation. The objective of this work is to assess its efficacy and safety.

This technology was identified by the early Awareness and Alert System, “SINTESIS-new technologies” of AETS-ISCIII. An early assessment of the technology was conducted. The searched databases were: Pubmed, Embase, WOS, Tripdatabase, ClinicalTrials.org and Cochrane Library. Clinical studies using the device published in any language until 10 October 2018 were reviewed.

We found 3 abstracts to congresses and 6 clinical trials that evaluated the use of the device. Outcomes measures among studies included spatiotemporal gait parameters, energy expenditure, muscular activity and functional performance. Five studies consisted in proof-of-concept analysis; 3 studies evaluated the effect of gait training with SMA® compared with conventional therapy alone in individuals after stroke (2 studies) and Parkinson disease (1 study); and 1 before-and-after study assessed the effect of gait training with SMA® in elderly adults. During its use, improvements in spatiotemporal gait parameters were described in 4/5 studies, and 2/5 studies showed less energy expenditure versus 2/5 studies that found no differences. After gait training, 3/4 studies described greater improvements in gait parameters when associated its use. Only one clinical trial collected safety data reporting no adverse events.

The SMA® device allows to increase the efficiency and parameters of the march during its use. The assistance in the stride might have an impact on health by facilitating the recovery of the gait; however, further research is needed to determine the feasibility in the latter case since comparative studies with conventional therapy are limited.

European cooperation in Health Technology Assessment (HTA) requires joint assessments to be of high quality, providing findings transferable into national HTA report. To this aim, we piloted the combining of methodological guidance of EUnetHTA for Relative Effectiveness Assessment (REA), GRADE for selection/rating of outcomes and assessing quality of evidence, and Cochrane for Systematic Reviews, while carrying out a collaborative REA on Femtosecond Laser Assisted versus Standard Cataract Surgery.

While developing the collaborative REA, we used the three organizations’ handbooks, templates and tools for Scope, Project Plan (PP), Summary of Findings, Effectiveness (EFF) and Safety (SAF) domains. We structured the PP according to the EUnetHTA template and added detailed methods on EFF and SAF systematic reviews, as per Cochrane Handbook. For the Scope we convened a multidisciplinary panel for selection and rating of importance of outcomes and clinically significant difference, using the GRADEpro platform. We developed the complete report adopting the EUnetHTA REA Core Model. We used Cochrane's tool Revman to assess risk of bias of included studies for each outcome, and to carry out metanalyses. We applied the GRADE approach to assess quality of evidence for each outcome and to express level of certainty in the estimates. We used the Cochrane handbook's guidance for structuring a scientific abstract and a Plain Language Summary to integrate the Summary of Findings.

The PP resulted in a detailed scientific and operational protocol, receiving extensive and constructive internal and external peer review. Reporting of EFF and SAF domains followed EUnetHTA Assessment Elements while keeping the order of stakeholders' rating of outcomes’ importance. Graphic representation of risk of bias for each outcome contributed to immediacy of the data quality assessment and transparency of the judgement on certainty. The scientific abstract and the Plain Language Summary, facilitated the external dissemination of results.

Merging of the three most important methodological contributions in the field proved successful without altering the distinctive trait of the REA.

The growing prevalence of non-communicable diseases, combined with greater recognition of the effectiveness of lipid lowering agents (LLAs), has fuelled their increasing use in recent years. Similarly, increasing recognition of mental health and, arguably, societal expectations and pressures, has driven appreciable growth in antidepressant prescribing in recent years. Concurrent with this, growing resource pressures enhanced by the continual launch of new premium priced medicines necessitates reforms and initiatives within finite budgets. Scotland has introduced multiple measures in recent years to improve both the quality and efficiency of prescribing. There is a need to document these initiatives and outcomes to provide future direction.

Assessment of the utilization (items dispensed) and expenditure of key LLAs (mainly statins) and SSRIs between 2001 and 2017 in Scotland alongside initiatives.

Multiple interventions have increased international non-proprietary name (INN) prescribing (99% for statins and up to 99.9% for SSRIs). They have also increased preferential prescribing of generic versus patented statins with low costs for generics, reduced inappropriate prescribing of ezetimibe due to effectiveness concerns, and increased the prescribing of higher dose statins (71% in 2015). These measures have resulted in a 50% reduction in LLA expenditure between 2001 and 2015 despite a 412% increase in utilization. Initiatives to reduce the prescribing of escitalopram as lack of evidence demonstrating cost-benefits over generic citalopram, along with high INN prescribing, achieved a 73.7% reduction in SSRI expenditure between 2001 and 2017 despite a 2.34-fold increase in utilisation. Concerns with paroxetine, and more recently citalopram and escitalopram following safety warnings, resulted in a considerable reduction in their use alongside a significant increase in sertraline.

Generic availability coupled with multiple measures has resulted in appreciable shifts in statin and SSRI prescribing behavior and reduced ezetimibe prescribing, resulting in improvements in both the quality and efficiency of prescribing to provide future direction.