European collaboration in Health Technology Assessments (HTAs) has gained increasing recognition in recent years, not only on pharmaceutical products but also on high-risk medical devices. For medical devices, quality assessments of efficacy and safety are particularly important due to the weak market authorization in Europe. Strengthening efforts towards better collaboration thus plays a pivotal role to reduce overlap and save resources. This study explored the level of redundancy in HTA assessments of medical devices in Europe in order to identify areas for better collaboration.

We performed an analysis of European HTA reports of medical devices regarding their timing in relation to market authorization, the respective level of evidence used and the overlaps in topics. The ADVANCE HTA database from 2014 was used to select a cohort group of ten high-risk medical devices. A systematic search was conducted to identify all relevant, European HTA reports investigating the ten devices within a time span of 12 years (2003-2015). We analysed the number of annual assessments per technology and evaluated activity patterns, late and early assessors, and minimum evidence requirements.

The results revealed the amount of redundancies in European HTA production: the number of reports per technology ranged from a minimum of five to a maximum of twenty-two over a time-span of 12 years. Within a single year, one technology was assessed up to six times by different HTA institutes in Europe. Out of fourteen countries included in the evaluation, two countries assessed each technology, and seven countries assessed more than seven out of the ten technologies.

The findings indicate that more efficient collaboration is needed to save scarce resources and time of HTA institutes. Efficient collaboration as such needs to shift the focus beyond the time span of one year, and start building on each others work from previous assessments.

Mechanical thrombectomy (MT) is used in patients with acute ischaemic stroke due to occlusion of a proximal cerebral artery. Over the years endovascular techniques have been used to re-canalise blocked vessels, but are not currently reimbursed by National Health Insurance in France.

The aim was to assess the efficacy and safety of MT in combination with intravenous tissue plasminogen activator (IV t-PA), or as an alternative to it, in adults with an acute ischaemic stroke who are not eligible for thrombolysis or in whom thrombolysis has failed; to support the reimbursement decision by National Health Insurance.

Within the scope of The European Network for Health Technology Assessment (EUnetHTA), a rapid assessment of “Endovascular therapy using devices for acute ischaemic stroke” was jointly produced with Haute Autorité de santé (HAS) as a reviewer.

The EUnetHTA report provided a systematic review based on eight randomized controlled trials (RCT) for effectiveness and all available published data for safety.

To produce its assessment, HAS has adapted the EUnetHTA report by:

1. 1. Updating the systematic literature review including the latest published trials

2. 2. Retaining the subgroup analysis of the five most recent trials considered more relevant in the EUnetHTA report for the assessment of effectiveness

3. 3. Analysing specifically the different endovascular interventions studied in the five RCTs

4. 4. Taking into account contributions from stakeholders.

This horizontal collaboration among European HTA doers has facilitated and shortened the assessment of the clinical benefit of this technology, confirming the relevance of EUnetHTA cooperation.

This clinical assessment of thrombectomy is to be completed by the evaluation of its organizational impact in the management of acute ischemic stroke.

Preference-based measures of health-related quality of life play a key role in the calculation of Quality-Adjusted Life Years (QALYs) for Health Technology Assessment (HTA). The Child Health Utility 9D (CHU9D) is a new preference-based instrument designed specifically for application in children and adolescents (aged 7 to 17 years). This study aimed to compare Chinese and Australian adolescent population preferences for CHU9D health states using profile case best worst scaling (BWS) methods.

Fifty CHU9D health states (blocked into five survey versions) were generated for valuation using a fractional factorial design. Study participants were recruited through an online panel company in Australia, and through primary and secondary schools in China. A latent class modelling framework was adopted for econometric analysis.

A total of 1,982 respondents (51 percent female) in Australia and 902 respondents (43 percent female) in China provided useable survey responses. Latent class analysis indicated the existence of preference heterogeneity for both population groups. In the Australian sample, respondents in Class I placed the most importance on the mental health dimensions of the CHU9D (for example, Worried and Annoyed) and the least importance on daily activities (for example, Activities, Daily routine, Sleep), whilst respondents in Class II placed equal weights on all attributes. In the Chinese sample, respondents in Class I placed the most importance on the Activities dimension of the CHU9D and the least importance on the Annoyed dimension, whist Class II placed the most importance on the Schoolwork dimension and the least importance on Pain.

This study has provided important cross-country insights into the use of profile case BWS methods to elicit health state preferences with young people for application in HTA in children and adolescents. The differential latent classes identified between Australia and China highlights the necessity to derive country-specific adolescent scoring algorithms for the CHU9D instrument for application in HTA.

We test in practice a Multiple Criteria Decision Analysis (MCDA) framework for the value assessment of a set of therapeutic options for the indication of hormone relapsed metastatic prostate cancer (mPC) through a series of simulation exercises with the participation of decision makers from different Health Technology Assessment (HTA)/insurance agencies across Europe, including TLV (Sweden), AETSA (Andalusia-Spain), INAMI-RIZIV (Belgium) and AOTMiT (Poland). The drugs evaluated were abiraterone, cabazitaxel and enzalutamide.

Using a multi-attribute value theory framework, past research outcomes and literature findings, an mPC-specific value tree was constructed incorporating relevant concerns as criteria. By adopting the MACBETH approach the different drugs were scored against the criteria through the development of value functions, relative weights were assigned to the criteria using a swing weighting technique, scores and weights were combined using an additive aggregation technique, and sensitivity analysis of results was conducted. All stages were informed through the participation of a small group of experts from each HTA/insurance agency at a series of decision conferences taking place in each country.

Value parameters considered spanned the dimensions of therapeutic impact, safety profile, innovation level and socioeconomic impact. Overall weighted preference value scores were produced reflecting the performance of the treatments against the criteria while considering their relative importance. Order of treatments’ rankings was identical across all agencies, with enzalutamide scoring highest and cabazitaxel lowest. Therapeutic impact criteria always produced the greatest relative weight. Hypothetical priority setting decisions were made based on “value-for-money” grounds through the use of “cost per unit of value” metrics by incorporating purchasing costs.

The MCDA framework tested possesses a number of characteristics that could facilitate decision making, including the systematic and explicit incorporation of value trade-offs as part of model assessment and the transparency throughout all its stages. Therefore, it has the prospects to act as a practical evaluation tool for value assessment and communication during the HTA process.

Gastric cancer (GC) is one of the most common malignancy and the third leading cause of cancer mortality worldwide. Currently, platinum-based and fluoropyrimidine-based combinations represent the milestone of front-line drug regimens. Unfortunately, there are few treatment options after failure of first-line therapy. Ramucirumab, a human IgG1 monoclonal antibody to VEGFR-2, has been recently approved in the European Union (EU) for use as monotherapy or in combination with paclitaxel as second-line treatment in patients with advanced GC with progressed disease. We performed a cost-effectiveness analysis of the Ramucirumab plus paclitaxel doublet versus paclitaxel alone in patients with previously treated advanced GC, based on results of the RAINBOW trial (1).

A Markov model has been developed in order to estimate the Life Years Gained (LYGs) and the incremental cost-effectiveness ratio (ICER) for both treatments. The model adopted the Italian healthcare system perspective and the time horizon is that of the lifetime of a patient with an advanced GC. The model considered three distinct health states: stable, progression or death. Transition probabilities were extracted from the Kaplan-Meier curves provided in the trial and cubic/spline function was used to approximate the extrapolation of survival curves for each treatment cycle. An internal model validation was performed to validate the Overall Survival (OS) curves generated by our model simulation. We based our economic analysis on clinical data and resource consumption (drugs, drug administration, supportive care medications, disease monitoring and graded 3 or 4 adverse events) on the Italian setting (2,3). All costs were expressed in euros. Sensitivity analysis also have been performed.

This cost-effectiveness study demonstrated that, in 2nd-line therapy, the combination of ramucirumab with paclitaxel provides an incremental benefit (+1.54) at high incremental cost (EUR41,616) per LYGs.

At a threshold of EUR5,000 for LYGs, based on Italian perspective, ramucirumab plus paclitaxel had less probability of being cost-effective. To our knowledge, our study is the first modeling study from an Italian payer perspective and the first worldwide to examine ramucirumab as a 2nd-line treatment.

Although many biologics (Bs) have been approved for the treatment of moderate-to-severe Ulcerative Colitis (UC) in patients who have responded inadequately to conventional therapy, the selection of Bs is controversial due to the lack of head-to-head trials. Indirect economic comparisons of these costly drugs are available from National Healthcare perspectives that are not the Italian ones. Therefore, the objective is to evaluate cost-utility of Bs for the treatment of refractory moderate-to-severe UC both in Italy and in the Lombardy Region.

A Markov model (considering three transition states: remission, clinical response, relapse) was constructed using the software R 3.3.1 markovchain-package to evaluate incremental cost-utility ratios (ICUR) of adalimumab (ADA), infliximab (IFX), infliximab biosimilar (IFX-B), golimumab (GOL) and vedolizumab (VED) treatments of patients over a 10-year time horizon from the perspective of the Italian (N) and Lombardy Region (R) healthcare system. Clinical parameters were derived from clinical trials. Costs (actualized by – 1.5 percent) were obtained from the National database and Regional public tender. Utility was expressed as QALY (Quality-Adjusted Life Years).

Costs per treatment were different from a N and R perspective (ADA -55 percent; IFX -16.7 percent; IFX-B -29.6 percent; GOL -9.6 percent; VED -10 percent). Direct healthcare costs (treatment cost, visits, laboratory tests, hospital admissions) were calculated over 10 years of treatment per patient: ADA (N: EUR114,227, R: EUR68,314, -40.2 percent), IFX (N: EUR130,595, R: EUR103,081, -21 percent), IFX-B (N: EUR110,438, R: EUR78,852, -28.6 percent), GOL (N: EUR118,602, R: EUR96,922, -18.3 percent), VED (N: EUR113,852, R: EUR102,932, -9.6 percent) with associated QALY respectively of 6.68, 6.66, 6.66, 6.70, 7.02. From a N perspective, IFX-B was dominating compared to all other treatments. The ICUR of VED/IFX-B was EUR9,483 for 10 years (willingness to pay EUR948/QALY). From a R perspective, ADA was dominating compared to all other treatments. The ICUR of VED/ADA was EUR101,818 for 10 years (Willingness to Pay, WTP EUR10,182/QALY).

National and Regional cost-utility analyses produced different results. As Regional price discounts can occur, local analysis is needed to estimate the economic impact of therapies to ensure optimal choice.

The reduction of healthcare costs and societal cost due to remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) has been demonstrated in several countries; however, to the best of our knowledge it does not exist for South Korea. This work aims at providing an estimation of the potential benefit of RM versus standard care (SC) of CIEDs in term of healthcare costs in South Korea, in order to provide additional substance to the currently ongoing societal debate about the value of telemedicine.

Healthcare resource consumption was taken from the results of the TARIFF study, a prospective, non-randomized, multicenter clinical trial designed in Italy to assess the economic benefits of RM follow-up in comparison with standard follow-up in 209 patients (107 SC, 102 RM). The main results demonstrated that RM reduced healthcare resource consumption by 54 percent from a healthcare services perspective (SC: EUR1,044.89±1,990.47 versus RM: EUR482.87±2488.10, p<.0001 (1).

In order to perform a cost analysis from the perspective of the South Korean healthcare payer, the following unit costs were assigned to resources collected in TARIFF (hospitalizations, visits, examinations): fee-for-service tariffs, emergency tariffs and outpatient tariffs. Remote follow-up costs were considered as zero.

From the perspective of the South Korean healthcare payer, the overall mean annual cost/patient in the RM group is 53 percent lower than in SC group (SC: EUR405,439±40,135 versus RM: EUR189,96±725,52, p<.0001) (SC: KRW 497,145±49,2137 versus RM: KRW 232,936±890,181, p<.0001). This is mainly due to a significant cost reduction in device-related hospitalizations, examination tests and visits in the follow-up period.

RM of CIED patients is cost-saving from the perspective of the South Korean healthcare system. Introducing appropriate reimbursement for remote monitoring of CIED is not likely to change this result and should make RM sustainable for the provider and encourage widespread adoption of RM.

The cost-effectiveness of Human papillomavirus (HPV)-based primary cervical screening in the Irish healthcare setting is assessed using a decision-analysis approach to inform a decision around changes to the national screening program. Current practices comprises primary screening with liquid-based cytology (LBC) followed by HPV triage, at 3-yearly intervals for ages 25 to 45 years and 5-yearly until age 60 years.

This study assessed changing the primary screening test from LBC to HPV testing, in both an unvaccinated and a vaccinated (against HPV 16/18) cohort. It considered extending the screening interval (to 5-yearly for all), the upper age limit (from 60 to 65 years) and different test sequences (four possible tests were included: HPV, LBC, partial genotyping for HPV16 or HPV 18 and the molecular biomarker p16INK4a/Ki67). A Markov-model for HPV-infection and cervical cancer was developed based on a German cervical screening model (1). The perspective of the healthcare system was adopted and a 5 percent discount rate used.

Strategies using HPV as the primary screening test are more effective than LBC-based strategies. The optimal strategy, at a willingness-to-pay threshold of EUR45,000 per quality-adjusted life year (QALY), for the unvaccinated cohort was HPV-based primary screening with a LBC triage test, at five-yearly intervals from age 25 to 60 years. This strategy is cost saving compared with current practice and cost effective when compared to no screening, with an Incremental cost-effectiveness ratio (ICER) of EUR18,164 per QALY. The optimal strategy for the vaccinated cohort was also HPV primary screening with a LBC triage test, at five-yearly intervals from age 25 to 60 years. While more effective and cost saving compared with current practice, it would not be considered cost effective compared with no screening (ICER of EUR58,745/QALY).

Based on our analyses, HPV-based cervical screening is more effective and cost saving compared with LBC-based screening for both vaccinated and unvaccinated cohorts in an Irish setting.

Misdiagnosis of asymptomatic bacteriuria as catheter-associated urinary tract infection (CAUTI) leads to unnecessary tests and other low-value care. We used this topic as the prototype to develop a clinical pathways program to promote evidence-based decision making in a multi-hospital system.

We convened a task force including hospital and critical care physicians, nurses, laboratory staff, and informatics specialists. Our Health Technology Asessment (HTA) center completed a rapid systematic review on guidelines and algorithms for diagnosing CAUTI. Additional rapid reviews were completed as necessary to address specific follow-up questions. A draft pathway based on the guidelines was developed, and then the task force edited it in an iterative process.

We used the Dorsata platform (Dorsata Inc., Washington, DC) to create, distribute and maintain the pathway. Dorsata has both desktop and mobile interfaces that guide clinicians through decision algorithms. Individual pathways include links to references and a portal for direct user feedback. Pathway owners have access to a real-time pathway utilization dashboard.

A standardized order set with the pathway was added to our electronic health record system. We also held educational meetings for residents and provided “huddle sheets” to nurse educators at each hospital. Posters and computer screen savers were also used to raise awareness of the new pathway.

We now have a total of 111 pathways on Dorsata, developed following the same model as the CAUTI evaluation pathway. Some topics, like breast cancer, have as many as sixteen pathways, addressing different clinical questions like first- and second-line therapy. Over 600 individuals have registered for the mobile app, including attending and resident physicians, nurses, and medical students. The pathway site had 1,619 views in December 2016, the most recent month for which complete records are available. The pathways are proving to have an effect on clinical decision making. For example, the annualized number of unnecessary urine cultures avoided as a result of the pathway is 4,474; resulting in estimated direct cost savings of USD67,110.

Using pathways to present HTA information at the point of care is feasible and can improve the value of care.

Hospital mangers need information for decision making (1). Hospital-based health technology assessment (HTA) methods were tested out to support the budget planning of investments for a new building to be constructed for diagnostic and teaching units at a publicly funded tertiary care university hospital. The hospital board nominated an ad hoc working group to reassess all investment proposals for devices, equipment and furniture for the diagnostic or teaching units that intended to move into the new building. The need for assessment was obliged when the submitted proposals of the units exceeded two-fold the initially allocated investment budget.

Depending on the level of expenditure, all proposals were assessed by one of the following processes: (i) Proposals over EUR250,000 were evaluated by three to five person expert groups using multi-domain assessment adapting Hospital-based HTA-principles; (ii) Proposals between EUR50,000 and EUR250,000 were returned to the units for miniHTA-assessments by clinicians who submitted the initial proposals and (iii) All proposals below EUR50,000 were prioritized by the units to cut the expenditure by at least 25 percent, with a special emphasis on synergistic use of devices and equipment among the units.

The expert groups suggested significant reductions to the proposals, including the withdrawal of a Magnetic Resonance Imaging (MRI)-unit considered to be suboptimally located. Furthermore, the need for a new scanner was declined by promoting adherence to evidence-based diagnostic guidelines and more efficient utilization of existing scanners. Self-assessed MiniHTAs revealed proposals that were unnecessary or the specifications for devices needed re-adjustments. Prioritization revealed excess numbers of devices, for instance the number of cold storage appliances could be reduced. Altogether, the investment proposals were cut by over EUR3.8 million to reach the initial budgetary allocation.

Innovative and flexible usage of hospital-based HTA methodology can be applied to budget planning and evaluation of investment proposals to support decision making. Based on encouraging results, hospital-based HTA was accepted to become a part of hospital strategy as a tool for the annual investment planning.

Inhibitors of Vascular Endothelial Growth Factor (VEGF) have made possible the treatment of the Retinal Vascular Diseases (RVD) for which there were limited therapeutic resources. The aim of this work was to estimate annual direct costs of major macular edema diseases in Italy in particular Choroidal Neovascularization (CNV), Diabetic Macular Edema (DME) and Retinal Vein Occlusions (RVO) from the hospital perspectives.

This descriptive study was aimed at quantifying direct costs incurred by five hospitals in Italy. Administrative and clinical databases of Policlinico Tor Vergata in Rome were analyzed for a 6-year period. In this context, it was possible to stratify patients depending on the disease and number of eyes treated. From these results, a survey with structured questionnaires was developed involving four other hospitals in Italy. Thanks to that, direct costs (drugs and specialist) were estimated from the hospitals perspective in 2016.

Interviews included 7,356 individuals of which 1,860 were treated in both eyes. Within the considered five hospitals, 64 percent of treated patients had CNV, 21 percent DME, and 15 percent RVOs. The average annual administration rate of anti-VEGF treatment resulted in 4.03 (Standard Deviation, SD 3.46) per patient eye: 4.69 (SD 1.75) for cases enrolled for less than one year (naïve) and 3.38 (SD 0.82) per patients treated for more than one year (experienced). Naïve patients had a mean per capita annual cost of EUR2,368 per eye (EUR2,536 for CNV; EUR2,280 RVO; EUR1,986 DME) of which EUR2,952 was related to the administration of on-label drugs mainly Eylea, Lucentis, Macugen, Ozurdex and EUR49 due to off-labels such as Avastin. Experienced patients average annual cost per eye was EUR1,689: EUR2.179 for the on-label drugs, EUR34 due to off-labels (EUR1,839 for CNV; EUR1,327 RVO; EUR1,399 DME). The average rate of the specialist annual visit was four times; the most frequent types were Optical Coherence Tomography (OCT), Angiography, and Fundus Photography (FP).

This is a first attempt to study direct costs incurred from the hospital perspective associated with RVD with overexpression of VEGF in Italy. This might represent a first step for further analysis assessing the burden of RVD diseases from the Italian National Health System perspective globally.

Increasing numbers of research papers about information retrieval for Health Technology Assessments (HTA), systematic reviews and other evidence syntheses are being published. It is time-consuming for information specialists to keep up-to-date with the latest developments in the field. To help searchers with this challenge, the Interest Group on Information Retrieval (IRG) of Health Technology Assessment International (HTAi) has compiled the best available research evidence on information retrieval aspects into an open-access web resource: Summarized Research in Information Retrieval for HTA (SuRe Info). The resource can be accessed at http://www.sure-info.org

The Sure Info team run topic-specific search strategies in selected relevant databases to identify information retrieval methods publications that fulfil the SuRe Info inclusion criteria. Eligible publications receive a structured abstract containing a brief critical appraisal. Key messages for search practice based on the appraisals and accepted best practice are summarized into topic-specific chapters.

SuRe Info currently offers fourteen chapters, with more in development. SuRe Info chapters fall into two categories: (i) chapters about general search methods that are used across all types of research, such as how to develop search strategies and the availability and use of search filters, and (ii) chapters summarizing the methods to use when searching for specific aspects of HTA (as defined in the European Network for HTA (EUnetHTA) HTA Core Model®), including searching for evidence on clinical effectiveness and safety, and identifying economic evaluations. References at the end of each chapter are linked to appraisals of publications that have been used to develop each chapter. Links to the full-text of the publications are provided when freely available. The SuRe Info chapters are reviewed every six months and updated if new evidence is identified or if resources change.

SuRe Info is a unique resource, identifying and summarizing current best research evidence on information retrieval aspects for HTA. It supports the timely uptake of potential efficiencies arising from new evidence that may be incorporated into the evidence identification processes of HTA organizations.

Budget Impact Analysis (BIA) is an integral element of a comprehensive Health Technology Assessment. Prior systematic reviews showed significant methodological dissimilarities in BIAs published from 2002 to 2015 (1,2). Aimed to improve the generalisability and transferability of outcomes, a guidance on methods was updated in 2014 (3). The objective of this study was to measure the adherence to Principles of Good Practice of BIAs published after the release of the updated guidelines.

Fifteen features representative of methodological appropriateness were identified from the Principles of Good Practice. A systematic review of the extant literature was conducted to identify BIAs published from January 2015 to December 2016. The adherence of each BIA to the Principles of Good Practice was defined by the number of representative characteristics taken into consideration as a percent of the total.

The full study protocol is available online: http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016049287

A sample of thirty-nine published BIAs were included in the analysis. The mean adherence of BIAs to the Principles of Good Practice was 69 percent (10.4 representative features out of 15). The highest adherence was 87 percent, while the lowest was 33 percent. The distribution of the scores was highly concentrated around the mean value, with thirty-four BIAs (87 percent of total sample) showing a level of adherence ≥ 60 percent. Only two BIAs reported an adherence < 50 percent (5 percent of total sample). Six representative features showed a level of adherence < 50 percent: off-label use (0 percent); uncertainty (26 percent); validation (33 percent); choice of computing framework (44 percent); eligible population (44 percent) and relevant features of healthcare system (49 percent).

Compared to the Principles of Good Practice, the BIAs included in the systematic review were overcomplicated and deterministic, ignoring the impact of possible scenarios relevant to budget holders. The research advocates a wider use of scenario planning as a tool to link uncertainty to the economic assessment of new interventions.

One of the challenges of large scale Health Technology Assessment (HTA) projects is managing the large volume of studies retrieved by the requisite comprehensive literature searches. At the scoping stage of the project, a pragmatic judgement needs to be made as to how sensitive the search strategy should be in order to find all the relevant papers without returning an overwhelming volume of irrelevant studies.

For this HTA (evaluating prognostic and predictive markers in rheumatoid arthritis), the research team already had prior knowledge of several key markers of interest, but wanted to ensure that no others had been missed. Advice from practising clinicians was obtained, but for additional validation, a broad scoping search was conducted for ‘rheumatoid arthritis’ using the sensitive Haynes filters for prognostic (1) and clinical prediction (2) studies. Unsurprisingly, this initial search retrieved too many studies for them all to be admitted to the full review; but once those dealing with known markers had been removed, a sample of the remaining records was loaded into a software visualization tool (3) to display “heat maps” of frequently occurring terms and phrases.

On this occasion, no additional markers were identified, however this provided reassurance that the advice obtained from clinicians was comprehensive, enabling the HTA team to proceed confidently with its evaluation of the selected markers.

Visualization offers an alternative means of exploring and interrogating large text archives, and has the potential to complement the role of traditional search methods in identifying literature for systematic reviews and health technology assessments. As processing power increases and more and more full-text papers become available open access, it may provide a solution to some of the limitations associated with comprehensive searching.

A predictive risk stratification tool (PRISM) to estimate a patient's risk of an emergency hospital admission in the following year was trialled in general practice in an area of the United Kingdom. PRISM's introduction coincided with a new incentive payment (‘QOF’) in the regional contract for family doctors to identify and manage the care of people at high risk of emergency hospital admission.

Alongside the trial, we carried out a complementary qualitative study of processes of change associated with PRISM's implementation. We aimed to describe how PRISM was understood, communicated, adopted, and used by practitioners, managers, local commissioners and policy makers. We gathered data through focus groups, interviews and questionnaires at three time points (baseline, mid-trial and end-trial). We analyzed data thematically, informed by Normalisation Process Theory (1).

All groups showed high awareness of PRISM, but raised concerns about whether it could identify patients not yet known, and about whether there were sufficient community-based services to respond to care needs identified. All practices reported using PRISM to fulfil their QOF targets, but after the QOF reporting period ended, only two practices continued to use it. Family doctors said PRISM changed their awareness of patients and focused them on targeting the highest-risk patients, though they were uncertain about the potential for positive impact on this group.

Though external factors supported its uptake in the short term, with a focus on the highest risk patients, PRISM did not become a sustained part of normal practice for primary care practitioners.

Europe's population is aging rapidly. Europeans aged 60 years and over formed only 16 percent of Europe's total population in 1980, but they now constitute 24 percent and will grow to 34 percent by 2050 (1). These challenges may be expected in the form of tighter labor markets, lower savings rates, and slower economic growth, as well as fiscal stress from lower earnings and tax revenue and increased pension and healthcare spending.

We may, however, overestimate the magnitude of these challenges and make poorer policy choices if we underestimate the productive contributions that older adults make to society. The literature measuring these productive contributions is regrettably underdeveloped, as is the literature on what policies can enhance such contributions.

This study focuses on the market and non-market productive contributions of older adults in Europe and addresses three questions:

1. (i) What is the nature and magnitude of the contributions made by older adults in Europe?

2. (ii) How do those contributions vary by country, time, and age, and how are they likely to evolve as the relative size of older cohorts swells?

3. (iii) How might changes in policy, institutions, behavior, and health likely influence the economic effects of population aging in Europe?

These research questions are explored using multivariate statistical tools to analyze rich data from multiple countries and waves of the Survey of Health, Ageing, and Retirement in Europe (SHARE) and the English Longitudinal Study of Ageing (ELSA).

Older adults in Europe make significant productive contributions in the form of labor force participation, caregiving for family and friends, and volunteering. These contributions vary widely by country and are correlated with age, health status, official retirement age, and population age structure.

The economic effects of population aging in Europe can be significantly moderated by effective retirement and healthcare policy.

Clinicians, epidemiologists, economists and other non-medical professions are involved in the production of Health Technology Assessment (HTA) reports. In addition, patients or representatives from patient organizations, as well as the general public, are increasingly involved. In 2015 a new proposal process of topic selection for HTA reports was initiated by German legislation with the aim of more closely involving patients and the general public. The new process has been implemented by the Institute for Quality and Efficiency in Health Care (IQWiG) under the project title “ThemenCheck Medizin” (Topic Check Medicine).

Since July 2016, patients and the general public can propose topics for HTA reports to IQWiG, excluding topics on the assessment of drugs. The proposals are submitted via the IQWiG website www.themencheck-medizin.iqwig.de (available only in German). No specific expertize is required for the submission of a topic. On the basis of the proposals a selection committee (patient representatives appointed by patient organizations legitimized in Germany) choose up to fifteen topics deemed suitable for HTA reports. In 2017 the committe will be extended to include members of the general public. IQWiG makes the final decision on the selection of up to five topics per year for HTA reports.

In the first proposal phase thirty proposals were submitted. The topics were allocated to the following categories: two for diagnostics; four for teeth; one for skin and hair; four for head and nerves; three for muscles, bones and joints; two for heart and circulation; four for cancer; two for children and adolescents; one for reproductive health and birth; and three for mental and emotional wellbeing. Four topics could not be considered because they either addressed the assessment of drugs or could not be transferred into an HTA question.

Through “ThemenCheck Medizin” patients and the general public in Germany can actively be involved in the process of collecting proposals for HTA reports as well as in topic prioritization. The prerequisites for successful implementation were in particular the easy-to-use online form and IQWiG's support of persons submitting topics in their formulation of an HTA question. The integration of a selection committee of patient representatives was shown to be constructive and productive.

Involving patients in defining the scope of health technology assessments is recognized as a valuable strategy that ensures that patient-relevant outcomes are considered.

The aim of this project was to pilot the focus group approach with cardiac patients in a European rapid assessment on the wearable cardioverter defibrillator, to improve involvement processes, to identify neglected outcomes, and to explore the potential of this methodology for eliciting the patients views on their disease and the wearable cardioverter defibrillator therapy.

An e-mail was sent to members of the nine regional associations of the Austrian Organization for Heart and Lung Transplant Patients to identify eligible participants. Guiding questions for the discussion were developed based upon a hand search of patient involvement initiatives and a review of appropriate literature. The 4-hour meeting was moderated by a patient support expert and recorded upon approval of participants. The anonymized transcript was analyzed using framework analysis.

Ten eligible patients responded, of which five men, aged between 55 and 73 years (mean 65 years) from Austria and Germany, were able to participate. All respondents experienced heart transplantation, and four had received an implantable cardioverter defibrillator before.

Participants reported that experiencing a sense of security was crucial to them and that they expected to do sports and live a life with few limitations, despite receiving a therapy. A wearable cardioverter defibrillator was hence not considered a long-term solution due to expected restrictions in living a ‘normal’ life.

Challenges included the identification of participants representative of this patient group and the complexity of patient histories.

The focus group approach proved useful in the wearable cardioverter defibrillator assessment. Gathered results informed the inclusion of outcomes relevant to the target group and revealed patients views on health-related quality of life. Lessons learned guide us in further improving patient involvement processes within the European Network for HTA (EUnetHTA) project.

The Health Technology Assessment International (HTAi) community recognises the importance of including patients’ views from published research and systematically obtaining input from patient organizations (POs). The HTAi's Patients and Public Involvement Subgroup has elaborated the Patient Group Submission Template for HTA (HTA Template) to facilitate the collection of evidence from patients via POs involvement. In 2015 AGENAS outlined a procedure to involve POs and tested the HTA Template within a Health Technology Assessment (HTA) report on dialysis.

The HTAi template was translated into Italian and adapted to the HTA report's specific information needs: to understand patients’ experiences with different dialysis modalities and any delivery problems at the regional level. Some questions were reformulated, others were cut and two different versions of the template were used. One was tailored to POs representatives and the other to individual patients selected with a purposive sampling procedure. We provided the HTA Template to POs appointed by an umbrella organization, Cittadinanzattiva, for their input and to identify other relevant POs to be involved. We identified a list of four associations, based on geographical location and typology of patients. Each POs representative completed the first template and administered the second one to, at least one patient for each five dialysis modalities. AGENAS staff provided support on a cascade basis POs collected and returned all templates.

Researchers performed a thematic analysis of the answers received and this input was introduced in the HTA report within the chapter on Patients Aspects. Patients’ experiences closely corresponded to the ones in our qualitative literature's systematic review. However, PO representatives templates revealed an important problem of equity in access to different dialysis modalities across regions that we highlighted in the HTA report's recommendations.

One of the template's limitations was related to self-administration. In some cases, a lack of familiarity with communicating one's views in writing may have affected the survey's informative power. This pilot also demonstrated the need for a more inclusive involvement procedure, as some important POs were not initially represented by the umbrella organization.

Priority setting in health care has been long recognized as an intrinsically complex and value-laden process. Yet, Health Technology Assessment (HTA) agencies presently employ value assessment frameworks that are ill-fitted to capture the range and diversity of stakeholder values, and thereby risk to compromise the legitimacy of their recommendations. We propose ‘evidence-informed deliberative processes’ as an alternative framework with the aim to enhance this legitimacy.

The framework is based on an integration of two increasingly popular and complementary frameworks for priority setting: multi-criteria decision analysis (MCDA) and accountability for reasonableness (A4R), Evidence-informed deliberative processes are, on the one hand, based on early, continued stakeholder deliberation to learn about the importance of relevant social values. On the other hand, they are based on rational decision-making – through evidence-informed evaluation of the identified values.

The framework has important implications for how HTA agencies should ideally organize their processes. Firstly, HTA agencies should take the responsibility to organize stakeholder involvement. Second, agencies are advised to integrate their assessment and appraisal phase, allowing for the timely collection of evidence on values that are considered relevant. Third, HTA agencies should subject their specification of decision-making criteria to public scrutiny. Fourth, agencies are advised to use a checklist of potentially relevant criteria, and to provide argumentation how each criterion affected the recommendation. Fifth, HTA agencies must publish their argumentation and install options for appeal.

Adopting ‘evidence-informed deliberative processes’ as a value assessment framework could be an important step forward for HTA agencies to optimize the legitimacy of their priority setting decisions. Agencies can incorporate elements according to their needs and affordances.