Following marketing authorization in Spain, new medicines are assessed by the Inter-Ministerial Pricing Commission for Pharmaceuticals (CIPM), which provides reimbursement recommendations with a maximum ex-factory price. However, there are 17 autonomous regions, which can make distinct reimbursement decisions. To drive consistency, the Spanish Agency for Medicines and Health Products has issued national Therapeutic Positioning Reports (TPRs) for new medicines since 2012. Since November 2017, CIPM recommendations have been published monthly, giving the opportunity to analyze the impact of TPRs on the speed and outcome of CIPM decisions, which this research evaluates.

Publicly-available CIPM and TRP decisions were identified from www.msssi.gob.es and www.aemps.gob.es, respectively. Marketing authorization dates were identified from www.ema.europa.eu or www.aemps.gob.es (10 March 2007-11 February 2018). Pearson's chi-squared and Mann-Whitney U statistical tests were performed using R.

One hundred and ninety-three drug-indication pairings with an associated TPR were identified. The majority (62% [120/193]) were recommended as alternative treatment options with only 19 percent (36/193) deemed to be superior and 19 percent (37/193) not recommended. One hundred and eight CIPM recommendations were identified across seven monthly reports, issued a mean of 12.2 months after market approval, 59 percent (64/108) were positive and 41 percent (44/108) were negative recommendations. There were 34 drug-indication pairings with both CIPM and TPR recommendations available. Of these, 24 percent, 56 percent and 21 percent had TPR outcomes of ‘superior’, ‘alternative’ and ‘not recommended’, respectively and 71 percent and 29 percent had positive and negative CIPM outcomes. Drug-indication pairings with ‘negative’ TPRs were significantly more likely to have negative CIPMs than those with either ‘alternative’ or ‘superior’ TPRs (71% vs. 19%, respectively, χ2 = 5.16, p = 0.02) and were more likely to experience significantly longer delays to CIPM recommendation (23.9 vs. 13.5 months, respectively, U = 50, p = 0.03).

Drug-indication pairings with ‘positive’ and ‘alterative’ TPR outcomes are associated with significantly better and faster CIPM recommendations than those with ‘not recommended’ TPR outcomes

The use of digital technologies in healthcare systems (digital health)– such as electronic health records and telehealth – can improve primary care (PC). However, integration of digital health can be constrained/impaired and/or facilitated due to several factors. We propose an integrative framework for classifying the factors that could favour or limit digital health integration in PC in order to guide the identification of strategies that could be helpful for technology promoters, managers, clinicians and researchers.

Based on a systematic review, our framework includes seven categories to classify the main opportunities and threats to digital health integration in PC: technological; individual/interpersonal; professional; organisational/institutional; ethical/legal; sociopolitical; economical. We consulted a panel of researchers, managers, clinicians, and citizens/patients in a scientific meeting regarding the main opportunities and threats to the integration of digital health in PC. We performed a content analysis of the reported factors according to the framework.

Technological factors such as maturity, interoperability and ease of use were often mentioned as key conditions for digital health integration. Individual and interpersonal factors such as depersonalisation and digital literacy were seen as threats. The impact on workload and shared responsibility were threats at the professional level, whereas silos and change management were noted as organisational threats. Current policies and social trends favored digital health. Threats regarding privacy and confidentiality were mentioned at the legal/ethical level. The possibility to reduce costs and sharing of benefits were noted as opportunities at the economic level.

Knowing these multidimensional conditions, perceived as either threats or opportunities depending on the context of each PC setting, is essential to inform decisions, from strategic planning to evaluation. Our integrative framework allows a simple classification of opportunities and threats that can guide the development and implementation of tailored strategies favouring the integration of digital health in PC.

Mobile Health (mHealth) apps offer potential to promote greater public engagement in health, improve efficiency and open up new care pathways and models of care. However, the volume and heterogeneity of apps has led to uncertainty and lack of standardization around app definitions. Some mobile apps carry minimal risks to consumers, but others can carry significant risks. Work has been carried out to develop a framework for assessment (for example, for the NHS app library [beta version]). We discuss work helping to inform a preliminary framework of categorizing mHealth apps for proportionate assessment and validation, and the challenges involved.

A literature review was carried out to identify different types of categorizations used to define health apps and the most important dimensions for their assessment. A taxonomy of apps and a process for routing them towards appropriate methods of evaluation was developed through iterative review, discussion and refinement.

Fourteen types of mHealth apps were established which were categorized by app function and by the potential risk involved with use. Subsequently, this research suggested a method of routing apps towards the most appropriate and proportionate method of evaluation, by using four example dimensions of impact (population size, disease burden, priority of clinical condition, and innovation), and four levels of risk.

The outcome of an evaluation framework should be to enable healthcare professionals and patients to select and use safe and effective mHealth apps with greater confidence. A preliminary taxonomy and method of routing apps towards appropriate assessment are presented. Both need larger scale discussion, iterative testing and refining. This research faced significant challenges, including a high volume of heterogeneous apps with poorly standardized app definitions and associated nomenclature.

Smart medical devices can empower elderly to live independently in their familiar surroundings. To enhance their dissemination, they have to be shown to be cost-effective. Economic studies evaluating such technologies are missing or are criticized for their low quality. There are several challenges in the evaluation of smart medical devices, including their complex nature and innovative character. The question arises: how can evaluations elicit the benefits and cost-effectiveness of smart medical devices. This research has the aim of outlining challenges and demands on the evaluation of smart medical devices.

The embedding of the technology in existing structures can influence the effectiveness of the technology. By comparing such a technology with a regular intervention, learning effects have to be considered. Regular modifications and further developments of these technologies can complicate the traceability of the effects. Complex cause-effect relationships with possible interactions arise that are difficult to quantify and express in standardized endpoints, utilities or monetary values. Demands on the evaluation of smart medical devices have been explored with literature reviews and scenario techniques using the example of intelligent rollators.

It is important to apply mixed-method approaches not only in the clinical but also practical setting and conduct observational as well as qualitative studies. Potential users, their relatives and care personnel should be involved in the evaluation of intelligent rollators and attention should be payed to subjects with disabilities. Prospective studies should be conducted at different stages along the lifecycle of the technology. A conceptual model should be developed and evaluated as well as adapted on a regular basis.

The research shows the need to adapt common methods used in economic evaluation to the characteristics of smart medical devices. As a next step, a framework for the economic evaluation of such technologies within the scope of Health Technology Assessment is developed based on these demands.

There are more than 320,000 accessible health apps, with the most downloaded of those related to physical exercise and weight control. However the initiatives for their validation address only partial aspects of the evaluation. The EVALAPPS project aims to develop an assessment tool for overweight and obesity management apps, based on the evaluation of efficacy, effectiveness and safety. In the present phase of the project, the team is co-creating the assessment tool considering both the evidence and the expertise of professionals (co-creation process).

Proposed co-creation methodology includes: 1) a modified Delphi process for selecting the assessment criteria. Criteria were identified through a) an exhaustive review of the criteria used by several mHealth assessment tools and b) a systematic review of efficacy, safety and effectiveness criteria used in mHealth interventions that assess overweight and obesity management. 2) a co-creation session using “Design Thinking” techniques for defining the final content and appearance of the tool (November 2018).

Ten dimensions and 133 criteria were identified, both in relation to the outputs (Usability, Clinical Effectiveness, Security, Development, etc.) and the outcomes (such as weight loss, number of steps). Of those, 114 were included in the modified Delphi, in which 31 professionals participated. A set of 63 criteria were selected as candidates for being part of the tool. Criteria mainly belonged to Security (22%) and Usability dimensions (14%), followed by Quality (11%), and outcomes related to Activity (11%) and Physical status (11%). Once the co-creation session has been performed, the final tool will be developed.

Relevant criteria to evaluate the efficacy and safety of mHealth interventions in the management of overweight and obesity have been identified. Once the tool is developed it will be user tested and piloted on users of overweight and obesity management apps.

It is not clear yet whether new digital health interventions can and should be assessed by using ‘conventional’ health technology assessment (HTA) methodology. In response to the question about how much and which type of evidence is needed for decisions on new digital health interventions, this presentation discusses complimentary evidence as generated through a critical-realist review and a qualitative meta-synthesis. This work follows from earlier work by AG Ekeland, AH Hansen and TS Bergmo.

A realist review addresses complex social interventions investigated in real life settings. The review was conducted with the purpose of generating knowledge on what works, for whom and under which circumstances. The aim was to enable decision-makers to reach a deeper understanding of how the intervention can be made to work most effectively. A critical review goes beyond mere description of identified articles and includes analysis and conceptual innovation. An effective critical review synthesizes material from diverse sources, provides an opportunity to ‘take stock’ and evaluate what is of value related to a previous body of work.

User patterns of clinical videoconferencing turned out to be dependent on contextual factors like clinical condition, motivation, technological skills, professional and organizational arrangements, trust and the perceived value they add compared with “services as usual”. The pattern of what works, for whom and under which circumstances was heterogeneous and dynamic. The review types helped identify and conceptualize new user categories, and understand the complex patterns of use.

The in-depth accounts of different clinical use resulting from such a review provide decision makers with a highly practical understanding of complex social interventions which is likely to be of use when planning and implementing programs at a national, regional or local level. A critical-realist review of digital services can complement controlled studies and evidence summaries in HTA.

The Victorian Department of Health and Human Services provided AUD 25 million (i.e. USD 17.3 million) over four years to determine the place of whole exome sequencing (WES) for patients attending public genetics clinics. Comparative analysis of WES and ‘usual care’ determined that WES increased diagnosis rate (from 14 to 58 percent), changed clinical management in one third of patients and identified relatives and couples at high risk of recurrence in future pregnancies. Translating this into routine care requires co-design with clinical and laboratory stakeholders.

Victoria's clinical and laboratory genetics service system uses a ‘hub and spoke’ model. Representatives from these were invited to join a ‘Clinical Adoption Group’ (CAG) to oversight implementation of new government funding (AUD 2 million (i.e. USD 1.4 million) per year) to ensure statewide access to, and funding of, WES for children with rare undiagnosed genetic conditions. The CAG developed terms of reference, ‘traffic light’ evidence-based eligibility criteria, a pricing model and reporting mechanism, and recommended funding for sequencing, curation, curator training and multidisciplinary team (MDT) meetings to support implementation.

Funding was distributed across hub and spoke sites reflecting clinical and laboratory demand and workforce requirements. All cases demonstrated clinical utility and were reviewed at MDT meetings. To date, 37 percent of patients have received a diagnosis changing management, with equity of access between metropolitan and regional areas demonstrated. Eligibility criteria are reviewed as new evidence is published to ensure new evidence is incorporated, although curation capacity limits turn-around-times.

Co-designing a statewide and evidence-based clinical model has resulted in sector (i.e. clinician and laboratory) buy-in and supported broad access to funded WES. In addition, the sector has developed a better understanding of how evidence informs policy and funding decisions, which has resulted in delivering equitable WES that provides early diagnosis leading to changed clinical management and cessation of unnecessary interventions.

There is ongoing debate as to whether conventional pharmacoeconomic evaluation (PE) methods are appropriate for orphan medicinal products (OMPs). The National Centre for Pharmacoeconomics (NCPE) in Ireland has a well-defined process for conducting pharmacoeconomic evaluations of pharmaceuticals, which is the same for OMPs and non-OMPs. The objective of this study was to identify whether supplementary criteria considered in the pharmacoeconomic evaluation of OMPs would affect final reimbursement recommendations.

A literature search was conducted to identify criteria. Orphan drug pharmacoeconomic evaluations completed by the NCPE between January 2015 and December 2017 were identified and supplementary criteria, where feasible, were applied.

Fourteen pharmacoeconomic evaluations were included in the study. Three criteria that could feasibly be applied to the NCPE evaluation process were identified, all three of which essentially broadened the economic perspective of the pharmacoeconomic evaluation. Higher cost-effectiveness threshold: Despite being arbitrarily raised from EUR 45,000/QALY to EUR 100,000/QALY, only one orphan drug demonstrated cost-effectiveness at this higher threshold. Weighted QALY gain: here, a weighted gain of between one and three is applied to drugs demonstrating QALY gains between 10 and 30, respectively. No OMPs included in the study showed a QALY gain of more than 10. Thirteen demonstrated QALY gains less than 10 and one could not be evaluated. Societal perspective: six submissions incorporated societal perspective as a scenario analysis. Despite incremental cost-effectiveness ratios (ICERs) being reduced between 4 percent and 58 percent, only two OMPs demonstrated cost-effectiveness at the higher threshold (EUR 100,000/QALY).

Application of supplementary criteria to the pharmacoeconomic evaluation of OMPs had a minor effect on three products assessed. However, for the majority, the final cost-effectiveness outcomes remained the same. The study highlights that other criteria are being considered in the decision to reimburse.

The Institute of Health Economics offers a suite of analyses that provide developers an understanding of the expected commercial viability of an early stage health technology. In combination, these analyses form the Value-Engineered Translation framework. These methods incorporate innovative methods to manage uncertainty in early economic evaluations, in particular, moving beyond current stochastic assessments of headroom to account for inter-market variability in value hurdles, as well as incorporating social value premia considerations. An illustration of these methods is demonstrated using the example of a non-invasive diagnostic test (called DCRSHP) at an early stage of development, compared to current practice of cystoscopy in the diagnosis of bladder cancer.

Competing technologies were identified to inform the headroom assessment based on price and effectiveness. Then, a model-based cost-effectiveness analysis was undertaken incorporating headroom analysis, stochastic one-way sensitivity analysis, and value of information analysis using data from secondary sources.

Currently there are a number of non-invasive tests available, but none have sufficient test accuracy to be suitable for bladder cancer diagnosis alone. From the headroom analysis, DCRSHP can be priced at up to CAD 790 (i.e. USD 588) and still be cost-effective compared to the current practice of cystoscopy. Interestingly this price can be increased for patient groups that have lower levels of bladder cancer prevalence.

The requirements of economic evaluations depend on the stage of technology development, and analysis approaches must reflect this. The results here indicate that DCRSHP clears the value hurdle in terms of being cost-effective, and thus provides the opportunity to make a commercial return on future investment. Future analysis of DCRSHP could consider the cost drivers for development of the technology, including the regulatory pathways, costs associated with the intellectual asset management for the technology, and alternative manufacturing costs. All of which contribute to the research-to-practice continuum.

Conventional wisdom suggests that accelerating the speed of cancer diagnosis should improve health outcomes. However, cancer diagnosis requires complex coordination and effective communication between care providers working across many areas of the healthcare system. Since 2000, several nations and jurisdictions have aimed to improve timeliness of cancer diagnosis by integrating and coordinating cancer diagnostic services for patients. The objective of this study was to describe the impact of these existing initiatives.

We conducted an environmental scan consisting of a literature review (published academic and grey literature) and key informant consultations (online surveys and telephone interviews with experts who have knowledge of existing initiatives). We searched for initiatives in the United Kingdom, the Nordic countries, Canada, Australia, and New Zealand. For each initiative, we extracted data on their development and implementation, structure and functioning, intended outcomes and effectiveness, costs and cost savings, and enablers and barriers.

Eighty-nine relevant documents and 20 key informants contributed to this study. We identified 21 relevant initiatives, including seven national initiatives targeting multiple types of cancer. The literature review found that most initiatives accelerated the diagnostic phase of cancer care by several days or weeks. These wait time reductions were often associated with improved patient experience, but not less advanced cancer stage or increased long-term survival. Insights from key informants improved our understanding of the costs, enablers, and barriers associated with program implementation and maintenance.

These results can be used as a first step to inform the development, evaluation, and improvement of international cancer diagnostic pathways. Stakeholders wishing to accelerate cancer diagnosis should consider the feasibility of achieving their intended program outcomes based on the existing research evidence, desired type of initiative, and jurisdiction's unique contextual factors.

Understanding of the role of contextual factors in determining the real value of health technologies is one of the major challenges for the use of Health Technology Assessment (HTA) methodology within hospitals. Moreover, the responsibility of assessing hospital performance is problematic. Although a number of managerial tools are available to appraise outcomes, there is little evidence on the role of contextual variables and how they might contribute to hospital performance.

Based on three extensive literature reviews, a pragmatic framework has been developed to understand interactions between organizational factors and health technologies on hospitals’ performance. Three main causal relationships emerge: (i) direct relationship between contextual factors and performance; (ii) an effect of contextual factors on the capability of technologies to “produce value”; (iii) an influence of organizational factors on clinical evidence-based decision-making. This pragmatic framework was designed within the IMPACT HTA EU Horizon 2020 Research Project.

The contextual dimensions are ascribable to five domains: organizational structure; managerial accounting tools; information, communication and technology (ICT) tools; human resource management (HRM) tools; hospital-based HTA procedures. The impact of contextual factors on technologies’ ability to produce value is highly overlooked in literature. Some effort in this sense exists only in the analysis of health information technologies. Moreover, among the contextual dimensions, only HRM tools have inspired a lively debate. The definition of hospital performance is amenable to multiple domains: accessibility, appropriateness, efficiency, safety and patient centeredness (continuity of care).

Although hospital performance is a pivotal topic in the healthcare sector, a deep understanding of how contextual factors may affect it is missing. The theoretical framework developed provides a tool to understand the multiple dimensions able to affect hospital performance. On one hand contextual dimensions may provide a direct effect on hospital performance. On the other, they may affect the extent to which technologies are capable of producing value.

Health technology assessment (HTA) was introduced into China more than 20 years ago and has developed rapidly recently. While only recently has the concept of hospital-based health technology assessment (HB-HTA) attracted attention in China. The purpose of this study is to investigate the views of government officials, decision makers and relevant stakeholders in the management and application of medical technologies in hospitals, within the environment of Health System Reform in China. We analysed the current situation and identified obstacles and prospects of HB-HTA in Chinese tertiary hospitals.

We conducted semi-structured interviews in 8 provinces in Eastern, Central and Western China; in 2 to 4 tertiary public hospitals in each province. We interviewed doctors, nurses, and Chiefs in hospitals, and key informants in the National Center for Medical Service Administration.

A total of 98 people participated in the panel discussions and interviews. We found that:

1. 1. China's tertiary public hospitals have embraced HB-HTA, and various hospitals have performed different forms of HB-HTA (including ambassador model, Mini-HTA model, and internal committee model). However, the assessment process, standards, and methods are yet to be standardized.

2. 2. The promotion of HB-HTA in China's tertiary public hospitals has remarkable external incentives and internal advantages.

3. 3. The lack of HB-HTA professionals, improvements in cognition level, and evidence-based decision-making models and management culture hinders the development of HB-HTA in China.

HB-HTA is in high demand in China, especially in tertiary hospitals. It will continue to develop rapidly over the next decade along with the development of China's HTA. HB-HTA will complement the national HTA to jointly extend the Chinese HTA system.

The use of stoma covers has been a common clinical practice for laryngectomized patients for several years. In the province of Québec, Canada, laryngectomized patients can obtain stoma covers through a dedicated program providing them with medical supplies and voice re-education services. For many years, the program's supply has included cloth and/or foam covers, but the supply of Heat and Moisture Exchangers (HME) has been limited. Two hospital-based HTA units joined their expertise to assess the opportunity of providing HMEs to more patients, depending on their clinical characteristics.

Their joined assessment rested on a systematic review (SR) and a field assessment. The systematic review aimed at assessing the efficacy, clinical effectiveness and safety of various types of stoma covers. The field inquiries intended to assess the perceptions of clinicians and managers towards stoma covers in clinical practice.

We included 27 studies in the SR. Most of them appraised the clinical effectiveness or safety of HME filters. Their methodological quality was very low with potential conflicts of interest whereas many studies were financed by the industry. The heterogeneity of study designs, expected outcomes and paucity of comparative studies prevented the pooling of results. Industry sponsorship appeared to be an important issue, since 17 of the included studies were sponsored. The SR did not provide conclusive evidence concerning the efficacy, clinical effectiveness and safety of the various types of stoma covers. The field inquiries intended to assess the perceptions of clinicians and managers towards stoma covers in clinical practice. It showed that industry representatives are quite active in clinical settings, promoting their products. Clinicians’ opinions and preferences were coherent with the systematic review main observations: in a context where the quality of the evidence is low, clinicians’ recommendations of stoma protectors for laryngectomies are mainly based on their professional experience and academic training.

Future research of high methodological quality would strengthen the evidence concerning the relative efficacy and safety of different stoma protectors. These studies would help define evidence-based allocation criteria and set parameters so that the choice of a stoma protector is best adapted to a laryngectomized patients’ condition.

Health Technology Assessment (HTA) is where facts and values meet: the evidence that is considered relevant to the assessment of a technology depends on the value framework used. In the context of the European project VALIDATE (Values in doing assessments of healthcare technologies), we assessed to what extent this interplay between facts and values is acknowledged in HTA reports on non-invasive prenatal testing (NIPT). Our aim is to gain a better understanding of this fact-value relationship, and to contribute to the development of capacity for ethical analyses in HTA.

Five reviewers independently analyzed HTA reports on NIPT, obtained from the National Institute for Health Research (NIHR) HTA database, by answering a structured questionnaire on: (i) arguments, values, and conclusions; (ii) relations between values and collected evidence; (iii) operationalizations of the values involved. Ethical argumentation was analyzed using the method of specifying norms. This method holds that for general, abstract ethical principles to reach concrete cases, principles need to be specified in such a way as to achieve maximal coherence between different value commitments and practice. The results of the analysis were discussed in joint meetings to arrive at a consensus on interpretation.

Our results show that the pivotal role of values in defining what counts as relevant evidence and why, is rarely acknowledged. The same holds for the importance of specifying values as a means to achieve greater coherence between the use of healthcare technologies and a range of values.

There is ample room for improvement in clarifying the role of values in HTA: they can serve to explain and justify what evidence is considered relevant to the assessment of a healthcare technology. Recognizing that abstract values need specification in order to reach concrete cases opens up new opportunities for exploring in what way values are affected by healthcare technologies.

Non-Invasive Prenatal Testing (NIPT) has already established itself in many European countries (either via public or private institutions) as an option at hand that pregnant women can choose. Based on mother's blood, NIPT claims to “quasi-diagnose” among other things the presence of chromosomal abnormalities caused by an aneuploidy of a chromosome (such as Trisomy 13, 18, and 21). Apart from normative issues concerning the question of “whether to fund NIPT by universal coverage”, NIPT gives rise also to normative issues concerning the question of “how to put NIPT into practice” – the analysis of which is the goal of this study.

Complemented by a hand search, we have conducted a systematic literature search in Ovid MEDLINE and PsycINFO for combinations of NIPT and nudging, NIPT and participation, and NIPT and ethics. Screening was based on content analysis of titles, abstracts, and articles. Writing of the study is in progress.

We identified 83 references of which 39 were included. The main instance of nudging (or also of unintentional choice design) was the use of default bias (the application or reduction of friction cost/hassle factor) that influenced the turnout to NIPT. In establishing NIPT in universal coverage systems, further potential biases identified were the use of authority bias, bandwagon effect, sunk-cost bias, and framing effect. The core ethical challenges with nudging in NIPT derive from the lack of transparency of the methods applied and the challenge of paternalism.

Along the line of accountability for reasonableness, four specific recommendations are suggested as the ethical guidance to using of the tool of nudging in NIPT: (i) decision makers should recognize that some choice design is inevitable, (ii) nudging should be done transparently, (iii) rationales for nudging should be publicly accessible. (iv) revision procedures should be put in place.

Health technology assessment (HTA) is value-laden. Consideration of ethical, legal, and social issues (ELSI), and patient values (ELSI+), is challenged by lack of conceptual clarity and the multi-disciplinary nature of ELSI + . This study used concept mapping to identify key concepts in the ELSI+ domain and their interrelationships.

We conducted a scoping review using Medline and EMBASE (2000-2016, English language) with search terms related to ethics, legal/law, social/society/patient, “ELSI”, and HTA/technology/assessment. Items from the review and additional items from an expert brainstorming session were consolidated into 80 ELSI+-related statements which were entered into Concept Systems® Global MAX software. Participants (N = 38; 36 percent researchers, 21 percent academics; 42 percent self-identified as HTA experts) sorted the statements into thematic groups that made sense to them, and rated the statements on their importance in decision-making about adoption of technologies in Canada: 1 (not at all important), 5 (extremely important), 2, 3, and 4 (unlabeled). We used Concept Systems® Global MAX software to create and analyze concept maps with four to 16 clusters, which were reviewed by the study team.

We selected the map with five clusters because its clusters represented different concepts and the statements within each cluster represented the same concept. Based on the concepts, we named these clusters: patient preferences and experiences, patient quality of life and function, patient burden/harm, fairness, and organizational. The highest mean importance ratings were for the statements in the patient burden/harm (3.82) and organizational (3.92) clusters.

This study suggests an alternative approach to conceptualize the domains originally described as “ELSI+”. We identified clusters of relevant concepts that focus on patient perspectives (preferences, experiences, quality of life, function), burden and harm, fairness (individual and societal), and organizational issues. Basing ELSI+ on conceptual consonance, rather than academic disciplines or traditions, provides a framework for coherent consideration of ELSI+ in HTA.

Transparency of processes and decision making is important to the Scottish Medicines Consortium (SMC). An independent review of access to new medicines in Scotland in 2016 recommended that SMC should review its communication of decisions with a view to achieving greater transparency. SMC therefore began to develop plain English summaries of advice on each new medicine.

A multi-stakeholder approach was adopted to develop the summary documents, with patient groups involved. Firstly, a review of communications for the public from other HTA organizations was conducted. The public involvement team then held a workshop to find out what patient groups felt would be important to include when explaining SMC decisions to patients and the public. The process was also informed by reviewing examples of good practice from other parts of NHSScotland, including patient versions of Scottish Intercollegiate Guidelines Network (SIGN) clinical guidelines. Exemplar documents were then developed and feedback sought from the Public Involvement Network Advisory Group.

A format was developed for the SMC ‘Decision Explained’ summaries consisting of a question and answer format for each medicine decision in a two page document. The summaries were piloted internally over a six month period, during which the development process and layout were finalized. Since September 2018 these summaries have been published on the website alongside the technical advice.

Partnership working between SMC and patient groups has helped to develop a new way of communicating SMC's decisions to patients and the public in a clear way, helping to improve transparency and understanding. Evaluation of the summaries will be undertaken from six months of publication.

The Scottish Medicines Consortium (SMC) encourages patient group (PG) representatives to participate in the decision-making committee meetings, answering questions from committee members and providing points of clarity throughout discussions if required. In a continuous improvement approach the process and the participant experience is continually evaluated to monitor impact and emerging themes.

The interactions between committee members and PG representatives are recorded in writing by the public involvement team to monitor the questions or points of clarity raised. These interactions were analyzed using thematic analysis to look for emerging themes. Following the meeting, PG representatives are invited to complete an online survey on their experience of working with SMC.

From July 2017 to October 2018, 36 PG representatives have attended committee meetings for the discussion of their submission. Committee members asked 17 PG representatives to contribute. Key themes that have emerged to date include insight into the impact of living with the condition on quality of life and how a new medicine may affect this. Survey feedback has been positive with participants reporting that patient engagement has been strengthened, and that the patient voice is heard, valued and supports committee members in making fully informed decisions. PG representatives expressed a willingness to participate again. Feedback also highlighted that the preparatory support offered to PG representatives by the public involvement team is highly valued.

Patient group participation in committee meetings has been received positively by PG representatives. They report that discussions relating to quality of life impact of medicines on patients and carers better reflect the lived experience, enriching committee's deliberations. This demonstrates SMCs commitment to openness and transparency and has strengthened patient engagement in our processes.

In December 2017, a patient involvement (PI) Interest Group was created in the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS) Annual conference. It started as a voluntary group of health technology assessment (HTA) methodologists interested in PI. The objective of the Group is to promote and facilitate PI in HTA. With the support of the Spanish Ministry of Health and the RedETS Council the Interest Group grew to at least one member for each of the eight RedETS regional agencies and units. It currently has 22 members. The PI Interest Group works in periodic online meetings and an annual offline meeting to establish a space for experiences exchange and reach consensus on main issues regarding PI.

RedETS published a strategy to facilitate effective and efficient PI in HTA processes in 2017. The long-term objective is to mainstream PI in all RedETS products. This strategy was built on a literature review and a qualitative study with semi-structured interviews. The interviews detected capacity building needs for technicians and methodologist in the network to be able to actively engage patients in HTA reports.

Since the kick-off meeting the PI Interest Group has worked in a number of activities. The main lines of action since its creation were: (i) evaluation of PI process in RedETS HTA reports in 2017 and in current reports, (ii) discussion on main methodological and procedural aspects, and feasibility of different patient participation approaches, (iii) development of technical protocols and templates to facilitate PI, (iv) the creation/adaptation of educational materials for patients and (v) translation of the HTAi Glossary for patients to Spanish.

Peer-to-peer learning processes can foster technical capacity of HTA methodologist in the Spanish HTA Network and may favor the implementation of the PI strategy.

NPS MedicineWise delivers nationwide educational programs for Australian general practitioners and community pharmacists. Extensive searching and synthesis of published and grey literature is undertaken to inform program design and development. However, this formative research process is lengthy, labour intensive and attempts to pre-emptively answer questions that could arise during design and development, prompting a process re-evaluation.

A more targeted and iterative process was piloted entailing: (i) rapid collation (two weeks maximum) of basic contextual information into a pre-scoping briefing document including high-level statistics on medicines or test usage, key guidelines identification and collation of findings from relevant government and stakeholder reports, (ii) an internal advisory group reviewing the pre-scoping brief and identifying the highest priority research questions that must be answered to inform the design and development of the educational program, (iii) iterative work to answer the highest priority research questions with findings provided to the advisory group fortnightly, involving ad hoc search methods and snowballing techniques to identify pertinent literature quickly, (iv) iterative feedback from the advisory group as to whether the resulting work is adequate and development or whether further information is required, and reprioritisation of the work plan if necessary, and (v) completion of the formative research process within four or five iterations. The new approach was evaluated via surveys of the internal advisory group and staff involved in design and development. Administrative data on staffing and costs using the new approach were also compared with previous data.

This approach was trialled for three different educational programs. The resulting reports are more targeted, answer specific advisory group questions and take half the time to produce.

This approach can rapidly provide appropriate information to inform program design. The iterative approach has allowed greater responsiveness to changing advisory group priorities and process improvements.