Health Technology Assessment (HTA) is applied to determine the value of innovative technologies. It usually relies on robust assessment of the clinical cost-effectiveness of the technology, while clinical and economic evidence required for this purpose are often not available for orphan drugs (OD) (1,2). The objective of the study is to undertake a systematic comparison between HTA agencies worldwide in order to identify similarities and differences in the methods and processes in HTA of OD.

A cross-sectional web-based survey was conducted between September 2013 and May 2015. The data were obtained from a semi-structured questionnaire. We received responces from 161 HTA organizations based in 39 countries.

HTA of OD is performed by agencies in South America (38.5 percent), followed by agencies in Australia (37.5 percent) and Europe (36.1 percent). The agencies in high income countries produce more assessments of OD (36.8 percent), which in 31.2 percent they determine as innovative technologies compared with 11.8 percent of the units based in low income countries and active in OD assessment (11.1 percent). We prove association (p< .05) between (i) the type of HTA and income per capita; the level at which the organization operates; its main activity; and the level of recommendation dissemination; (ii) the main target group and consumers of the final HTA product; the stage of evolution of the technology, on which it is likely to be assessed; and approaches to identify innovative technologies. The most active in the preparation of HTA reports are biomedical companies or other organizations in the private sector (50.0 percent) and organizations in the pharmaceutical and/or medical industry (66.7 percent). HTA bodies that assess OD develop (36.0 percent) and distribute recommendations (35.9 percent) nationally; their main activity is to produce guidelines for good clinical practice (46.9 percent). Agencies that perform OD assessment are active in evaluation of innovative (37.2 percent) and emerging (35.9 percent) technologies, which are able to be identified by developing early warning systems (32.0 percent).

Making coverage decisions based on HTA recommendations control the technologies introduction into the healthcare system, that is why it's very important that this tool is properly adjusted to the specific needs of OD assessment (3).

Governance of health technologies in Emilia-Romagna region, Italy, includes a local and a regional level. Medical devices (MDs) are requested by clinicians to hospital committees that may carry out an evaluation at local level or ask for a regional evaluation using Health Technology Assessment (HTA) methodology. Until the past year, committees weren't provided with a clear pathway to identify technologies for regional HTA evaluation. The aim of this study was to describe a bottom-up, shared approach to produce a tool with elements to be considered when judging if a technology is eligible for regional HTA or not.

To identify elements, we adopted a qualitative approach and the methodology of focus group (1,2) which consisted in starting from health professionals experience to build a shared knowledge. Two panels of stakeholders were convened, the first one comprising regional decision-makers deciding whether to reimburse and introduce a MD in Regional Health System; the second panel comprised regional clinicians that use, test and ask for MDs. Panels were asked to capture possible elements of MDs that should be considered for identifying the most promising and interesting ones for a regional HTA.

The two panels (seventeen regional clinicians and twenty-two decision makers, respectively) had two operative meetings and worked in parallel. At the end of the second meeting, a draft of the tool with elements identified by both groups was built. Panels were asked to test the draft on few medical devices and identify possible tool's criticalities limiting transferability. Tool resulted user-friendly and complete, requiring no changes. The final version, approved by two panels convened together during the last meeting, reports thirty-two distinct items referred to five domains (that is, potential: innovativeness, clinical, economic, and organizational impact, environmental factors). Each item must be valued on a Likert scale. The tool will be applied on every MD requested by regional clinicians and before implementation it will be tested during a 6-month pilot phase beginning March 2017.

The process was plain and feedback from stakeholders has been positive. The tool is expected to increase transparency and homogeneity in identifying technologies eligible for regional HTA.

One of the initiatives promoted by the Department of Health of Catalonia to promote the policies of clinical safety and quality of care was the construction of a synthetic indicator to obtain a global ranking that assess the quality of care and recognizes the best acute hospitals in Catalonia.

For the selection of dimensions and individual indicators, focus groups with experts, focus groups with patient representatives and a wide consensus process with health professionals were carried out. Weights of dimensions and indicators have been obtained from this consensus with experts. We identified fourty-seven individual indicators grouped into four dimensions, fourty-nine hospitals grouped into five categories were included. Goal programming methodology was used to construct synthetic dimensional indicators and then aggregate to obtain the global ranking based on the global synthetic indicator.

The best situation regarding quality of care of general acute hospitals is achieved in hospitals with better indicators of both the clinical effectiveness and adequacy dimension and patient safety, specifically the synthetic indicator places the hospitals with lowest percentage of patients with postoperative complications or with lowest percentage of infections of organ-space surgical localization in elective colonic or rectal surgery in a better position. Both in the synthetic global indicator and in the synthetic dimensional indicators, position the county hospitals as the best in the ranking, followed by reference hospitals.

We have presented a new methodology to assess the quality of care of hospitals which offers several advantages over existing ones. It is designed to be practical and to facilitate obtaining synthetic indicators that can be easily interpreted, based on information provided by the reference value corresponding to each indicator and adjusted by the clinical criterion supported by the consensus of more than 300 experts in the field of the evaluation of hospital care quality.

The outcomes from clinical and other healthcare trials of most interest to patients and health systems are usually increases in the quality and length of life (overall survival (OS)). This poses a problem, because complete knowledge on the true increase in OS is not available until the last person in the trial dies. However, if OS is sufficiently correlated with a surrogate endpoint that is observable within the trial period or soon after the treatment has finished, this can be used to estimate OS, without much error. The most widely-used surrogate endpoint in oncology is progression-free survival (PFS). We aim at (i) analyzing the methods used to extrapolate from PFS to OS in the field of oncology; (ii) identifying whether a clear guidance exists in the literature about what is considered to be ‘best practice’ in extrapolation from PFS to OS; (iii) determining the key limitations, weaknesses and gaps in the current literature and method used to test PFS surrogacy.

We extend the literature review carried out previously (1), we interview experts from regulatory and reimbursement bodies, and we explore academic research into the methodology of surrogacy and the need for better reporting of surrogacy papers.

A number of factors affect the relationship between PFS and OS. Therefore, there is no unique correct answer for the question of whether PFS is an appropriate surrogate for OS in oncology. Many of these factors are related to the length and characteristics of post-progression survival (PPS).

Any consideration of evidence relating to PFS should consider both tumour type and other factors, particularly those related to PPS. Protocols of future follow-up of clinical trial patients should specify procedures for gathering information about the effect of post-progression management of the disease. This should allow stronger conclusions to be extracted from statistical analyses. Improved reporting standards will aid in achieving this goal. In addition, it is very likely that increasing the use of IPD will result in greater precision in estimating the benefits of worthwhile drugs.

Transient Ischaemic Attack (TIA) is a neurologic event with symptom resolution within 24 hours. Early specialist assessment of TIA reduces risk of stroke and death. National United Kingdom (UK) guidelines recommend patients with TIA are seen in specialist clinics within 24 hours (high risk) or seven days (low risk).

We aimed to develop a complex intervention for patients with low risk TIA presenting to the emergency ambulance service. The intervention is being tested in the TIER feasibility trial, in line with Medical Research Council (MRC) guidance on staged development and evaluation of complex interventions.

We conducted three interrelated activities to produce the TIER intervention:

• • Survey of UK Ambulance Services (n = 13) to gather information about TIA pathways already in use

• • Scoping review of literature describing prehospital care of patients with TIA

• • Synthesis of data and definition of intervention by specialist panel of: paramedics; Emergency Department (ED) and stroke consultants; service users; ambulance service managers.

The panel used results to define the TIER intervention, to include:

1. 1. Protocol for paramedics to assess patients presenting with TIA and identify and refer low risk patients for prompt (< 7day) specialist review at TIA clinic

2. 2. Patient Group Directive and information pack to allow paramedic administration of aspirin to patients left at home with referral to TIA clinic

3. 3. Referral process via ambulance control room

4. 4. Training package for paramedics

5. 5. Agreement with TIA clinic service provider including rapid review of referred patients

We followed MRC guidance to develop a clinical intervention for assessment and referral of low risk TIA patients attended by emergency ambulance paramedic. We are testing feasibility of implementing and evaluating this intervention in the TIER feasibility trial which may lead to fully powered multicentre randomized controlled trial (RCT) if predefined progression criteria are met.

The use of health apps is rapidly increasing. They intend to promote health or to treat diseases; in some cases, substituting medical duties. No specific frameworks to assess mHealth solutions in a broad scope and in a comprehensive way have been identified. We aim to propose a framework for mHealth assessment.

The framework development was based on:

• • Literature review to identify existing assessment models including the evaluation of health effects

• • Exploratory analysis with experts and user group discussions

• • Definition of the assessment model, following the domains of health technology assessment.

Existing frameworks are mainly focused on certification criteria. Professionals and users agreed on the need to undertake mHealth assessments as to better inform user decisions. Assessments should be sensible to continuous changes of these technologies and be undertaken by independent organizations.

The proposed framework offers a step-by-step process by which any mHealth solution can be categorized and analyzed, according to: (i) Risk classification matrix: combining intervention type and patient type, (ii) Users: patients, professionals, informal caregivers individually or all of these together and (iii) Integration: stand-alone, fully integrated.

The model has four evaluation domains: technical maturity, risks, benefits and resources needed, including the commonly accepted evaluation perspectives: technical, contents, clinical/health, user perspective, organizational and socio-economic. Sub-domains are defined as: end-user, organization, healthcare system and community (society as a whole). Aspects to be assessed are selected according to the purpose of the evaluation (intended use / intended impact) and vary depending on the type of the mHealth solution: product or service.

The mHealth assessment process is needed and should be: (i) continuous/iterative, providing timely conclusions and recommendations for improvement, (ii) inclusive/collaborative, involving all stakeholders,and (iii) constantly adapting to standards. The proposed framework is intended to support informed decisions when developing, integrating, selecting, recommending, or adopting mHealth solutions.

With the possibility to analyze gene expression a plethora of new genomic tests are surging into the medical market. The assessment of these new technologies in Health Technology Assessment (HTA) reports is challenging and we need international consensus on uniform criteria to support HTA, but also to establish clear and standardized requirements for clinical studies.

The German Institute for Quality and Efficiency in Health Care (IQWiG) has been commissioned to assess the benefits and harms of biomarkers to predict which women would benefit from chemotherapy treatment after surgery of primary breast cancer. The final report was published in October, 2016 (1).

Only eight studies complied with the inclusion criteria of the systematic review. No prognostic study fulfilled the inclusion criteria. Only two randomized controlled trials (RCTs) delivered information utilizable for benefit assessment. Based mainly on 5-year results from the MINDACT trial, the report concluded that there currently is not enough information to support a positive decision on biomarkers in this specific indication. Ongoing randomized controlled trials like TailorX, PlanB, RxPONDER, ADAPT or OPTIMA are expected to provide some additional evidence in the near future. After publication of the IQWiG report an extensive debate on several methodological characteristics of this report was fuelled. In addition, some other HTA agencies, such as the National Institute for Health and Care Excellence (NICE) made slightly different conclusions.

The presentation will give a résumé of the main arguments and focus on differences between the IQWiG report and other HTA reports. Questions, like the required study type, study characteristics (for example, attrition rate, follow up, outcomes), data quality, cut-offs or patient preferences in diagnostic information will be provided. The aim of the presentation and discussion is to get a step forward in defining key characteristics and elements of benefit assessment and primary studies for these new technologies. A consensus among HTA reviewers in these approaches seems to be essential in the near future.

No single assessment can evaluate the wide spectrum of health technologies pending access to healthcare systems. It is important to envision a complex systematic framework, in which different instruments are used for different purposes - all criteria should be used to ensure the transparency of the process, and should model good assessment and implementation practices (1,2).

A cross-sectional web-based survey was conducted from September 2013 to May 2015 which was designed to gain information about the present status of Health Technology Assessment (HTA) activities; to examine its institutional contexts and the kind of application of its principles, logic, assessment methods, tools and best practices.

A total number of 161 questionnaires from 39 countries on 6 continents were received representing a 41.7 percent response rate. Based on analysis of the results, a complex systematic framework for value assessment was designed. Five major features define the framework that can fully measure the common and support the evaluation of more complex health technologies: (i) implementation of higher-order evaluation approaches that support complex multi-criteria assessment, rather than emphasizing only the use of basic evaluation procedures; (ii) precise evaluation of critical criteria, that measure technologies directly as they will be used in actual practical settings; (iii) assessment approaches, based on international best HTA practices that are accurate, in terms of the content and context of the evaluated technology, as well as the expected performance; (iv) high-fidelity priority-setting elements that are evaluation sensitive; and (v) assessments that are sound, unbiased, and transparent – in order to be truly valid for a wide range of technologies, assessments should evaluate them accurately and do so reliably across technology content and context. They should be unbiased and accessible and used in ways that support superior outcomes and higher quality for healthcare systems.

The healthcare systems that decide to use this framework should evaluate the set of assessments they select and develop them against the standards required, and should use them in ways for which they have been appropriately validated and in contexts that ensure a transparent evaluation process (3).

Among economists, there is widespread agreement that the monetary valuation of health gains should reflect the preferences of those who will be affected by resource allocation decisions. In the context of Health Technology Assessments (HTAs), this view implies a need for reliable empirical estimates of the value of statistical life year (VSLY), which should provide a useful point of reference for cost benefit analyses.

We conducted a systematic review of the literature on the economic value of a statistical life (VSL). We searched in the EconBiz and EconLit databases for studies, which reported VSL estimates based on original research and were published between 1995 and 2015. We classified studies by methodology, that is, revealed preference (RP) or stated preference (SP; that is, CV, contingent valuation, or DCE (discrete choice experiment) approach, and by regional origin of data. We transformed VSL estimates into VSLY expressed in year 2014 Euros, using life expectancy tables for the populations studied, a real discount rate of 3 percent, national Consumer Price Indices for inflating, and purchasing power parities for currency conversion. In addition, we calculated ratios of VSLY to gross domestic product (GDP) per capita.

Our search yielded 120 studies appropriate for inclusion. From these, we extracted a total of 132 VSL estimates (RP, n = 60; SP, n = 72). The median VSLY was 6.4 times GDP/capita. Transformed into Euro (2014), the median VSLY was EUR165,000 (mean, EUR217,000). We found significant differences by regional source of data (North American, median EUR272,000; European, EUR158,000) and by method (RP, EUR241,000; SP: CV, EUR117,000; DCE, EUR187,000). VSLY estimates were sensitive to discount rate.

Our data indicate that VSLY estimates based on empirical data exceed benchmarks commonly used in the context of HTAs. However, inter-study variability, methodological limitations, and normative considerations, all suggest to exercise caution before translating this observation into actual policy.

An effective installed medical equipment base management requires an information flow of Biomedical Technologies (BT) providing a common and standardized methodology for data collection and inventories management, representing the knowledge base for the BT assessment and procurement planning.

In a North Region of Italy a standardized methodology for BT regional codification has been defined to univocally identify BT, by classifying health fields and specialities, technological classes, models and manufacturers. Since 2012, an information flow of BT, named FITeB, allows to monitor and follow-up large medical equipment (LME), innovative equipment (IE) and widespread technologies (WT) set up in public settings, through biannual equipment census (1,2). Data about classification, identification, location, age, operating status, way of acquisition, economic value and maintenance have been analytically collected for LME and IE. LME data have been integrated with the information flow for public funding management allocated to regional healthcare buildings through other procedure. The number and economic value of WT have been collected. FITeB data have been used for the Regional planning procedure for medical equipment procurement (3).

The distribution of BT, their age profile, technological burden and innovative components as well as the overall economic value, have been estimated with FITeB. In 2016, information about 341 LME was collected; LME mean age was 7.4 years with a value of EUR248,353,000. The 293 IE were set up with mean age of 5.9 years and an overall economic value of EUR20,167,000. The WT amounted to 45,263 equipment with a value of EUR843,353,000. Over the years 2014 and 2015, the Public Hospitals and Local Health Authorities (ASRs) submitted 491 BT requests, of which 87 percent were replacement/new acquisition/upgrade, 9 percent innovative acquisition and 4 percent donations.

Critical issues can be identified from FITeB indicators representing the basis for BT procurements assessment and definition of strategies of replacement, introduction or relocation of medical equipments in the Region. An integrated information flow, as the case of FITeB, is an useful knowledge tool for appropriate governance, planning and management of BT.

Acquired hemophilia A (AHA) is a rare coagulation disease characterized by frequent bleeding episodes treated with plasma-derived products and bypassing agents as rFVIIa and aPCC. Similar to the previous plasma-derived porcine FVIII and without its side effects, pFVIII (Obizur®) is a porcine recombinant factor VIII produced with the recombinant DNA technique. The study analyzes the economic impact of pFVIII compared to the other available therapies in order to manage the bleeding episodes in AHA patients.

To assess the impact of the introduction of pFVIII in the market-mix of products for the management of AHA a budget impact analysis was conducted from the perspective of the Italian National Health System (INHS) and considering a three-year time horizon. Consumption of products, products’ wastage, needs for additional treatment in case of failure of first line therapy, laboratory tests, hospitalization and drug wastage were considered for cost estimation. Model inputs were derived from literature, preliminary experience with the use of pFVIII for compassionate use, and from the updating of previous evidence by data collected among a panel of clinical experts. Univariate sensitivity analysis was performed to explore overall uncertainties in input parameters.

The management of a bleeding episode considering conventional treatment is EUR8,229,621 per year, with an overall cost over three years equal to EUR24,688,864. The introduction of pFVIII leads to an overall costs saving ranging from EUR2,253,938 and EUR1,196,985 when the treatment duration is varied between 5 and 6.5 days, according to data from compassionate use or literature, respectively.

The model outlined a significant reduction of all the components of direct costs for the INHS when Obizur® is introduced into the market with an ex-factory unit price equal to EUR2.32/IU.

In the past decades the cost-effectiveness of new effective disease-modifying therapies (DMTs) for Relapsing Remitting Multiple Sclerosis (RRMS) form was assessed through decision analytical models. Recently, new treatment option for the Primary Progressive (PPMS) form was developed. Aim of this work was assessing the similarities and differences of PPMS and RRMS and their impact in the development of decision analytical model for PPMS.

Literature review was performed to retrieve information on natural history of PPMS and RRMS and impact of DMTs agents on the progression of these conditions. Further, a review of the published cost-effectiveness models for RRMS was performed. Based on these data, an analysis on the difference and similarities between the two MS forms that could have an impact on the development of decision analytical model for PPMS was performed.

Based on the analysis, similar structure model used for RRMS could be applied for PPMS. Health states of the model could be based on Expanded Disability Status Scale score as already done for RRMS. The relapse events considered for RRMS should not be included in PPMS model, and no possibility to develop another form, as the Secondary Progressive, should be included. While RRMS models should include at least a second line treatment option due to alternative DMTs available, only first treatment line should be considered for PPMS. Assessing data available to populate the model, poor data on the natural history, utility and cost associated to PPMS were available and assumption or expert opinions will be needed to overcome the lack of robust data.

A decision analytical model for PPMS can use a similar structure used in the models for RRMS. However, more robust data on PPMS and some structural change are needed to provide a good tool to assess cost-effectiveness of DMTS in PPMS.

While optimal medical therapy (OMT) represents the current standard of care for treatment-resistant hypertension, non-pharmaceutical therapeutic approaches, such as renal denervation and carotid baroreceptor stimulation therapy, have been proposed. The present Health Technology Assessment (HTA) project was aimed at assessing benefits and risk of those approaches versus OMT.

A systematic review of evidence on effectiveness and safety was performed together with a review of economic studies. A contextual analysis of market availability and use of the technology in Italy was also performed.

In Italy, ninety-nine renal denervation procedures were performed in 2014. Ten studies from six trials were included in the review and meta-analysis. No evidence of dominance or increased harms of renal denervation compared to OMT were found. Four economic evaluations were included and reported dominance of renal denervation. These were based on short-term clinical data and three evaluations used the same Markov model assuming dominance of renal denervation. Estimated average prospective cost of the procedure was EUR6,129.90 (range EUR3,821.15 – EUR9,714.23). We updated the results of an earlier assessment published by an Italian Regional agency on carotid baroreceptor stimulation therapy (1). None of the three studies identified as ongoing in 2015 were completed or had published preliminary results and the technology was not assessed further within the present HTA project.

Even if follow-up was limited to 6 months, randomised evidence showed no benefits of the procedure. Economic evaluations were unreliable, based on unrealistic assumptions of effectiveness and contrived therapy regimes. Further investment in renal denervation should await the results of well-designed and adequately followed-up trials assessing the impact of renal denervation on major cardiovascular events compared to OMT. Future economic evaluations should be based on realistic assumptions of cost and effectiveness.

The proliferation and uneven diffusion of new medical technologies in recent years has been raising concerns on affordability and equity of care, and inspiring the publication of scientific articles on the determinants of their uptake and adoption (1). Indeed, the knowledge of the determinants spurring the adoption and diffusion of innovative medical technologies is relevant for policymakers because it helps them implementing evidence-based health policies aimed at influencing the use of new technologies, thus reducing inequities in uptake rates across areas and populations.

The aims of this study were (i) to identify the empirical literature investigating the determinants of adoption and diffusion of innovative non-pharmaceutical health technologies, and (ii) to discuss the existence of consensus on the direction and significance of the factors that influence their adoption in each phase of technologies life cycle (that is, early adoption, adoption, diffusion).

We performed a systematic literature review of quantitative empirical literature.

We identified a total of thirty-three studies, published between 1977 and 2014. We concluded that early adoption of innovative technologies is positively affected by physician characteristics (for example, experience with new technology by the practitioner or by other physicians in the same hospital) and by the fee-for-service reimbursement scheme. The probability of adoption is mainly driven by provider characteristics (for example, size, importance of being perceived as technology leaders, previous adoption of similar or substitute technologies, strong medical staff involvement in decisions of acquisition), by physician experience with the technology and by the new technology expected impact on hospitals and physicians revenues. Socio-economic determinants (for example, health expenditure), hospitals and physicians reimbursement schemes, market structure (for example, number of providers, number of substitute procedures), provider features (for example, size, quality of care, reputation), and physician characteristics (for example, experience with technology, innovator status of the team) significantly increased the extent of diffusion.

Our results can be used as a guide by policymakers who wish to make evidence-based decisions.

Cystic Fibrosis (CF) is a genetic disorder caused by mutations in CFTR gene. In Italy, reported prevalence is approximately .70 per 10,000 inhabitants (1). The practice and recommendations for Cystic Fibrosis carrier screening are very heterogeneous in Europe. A proposal of a carrier genetic test in the general population raises many questions. Health Technology Assessment (HTA) could offer a sound methodological basis for this evaluation. The aim of this work was to summarize the available evidence, using the HTA approach, on the genetic tests for Cystic Fibrosis carrier screening.

A systematic literature search was used to find the best available international and national evidence on genetics test for CF carrier screening. In this report, we specifically addressed the health problem of disease, description and technical characteristics of tests – its analytic and clinical validity, and clinical utility. Economic evaluation of different scenarios was synthesized from the literature. Ethical, organizational, and social aspects of CF and genetic screening were also considered.

Several screening strategies have been evaluated in the literature and screening options can be characterized by different timing, model and place of screening (2). The reported cost of a screening test ranged from EUR25 to EUR212 (3). Estimated life time cost of care for CF patients ranged from EUR291,048 to EUR1,105,452. Ethical analysis emphasized that the use of these tests is an advantage in terms of the acquisition of knowledge and of responsible management of choices, but at the same time raises many ethical questions. Social considerations reported among patients and their families an overall positive attitude toward population CF carrier screening.

The advances in the molecular genetics technology have made CF carrier testing reliable and affordable. The multidisciplinary approach of this HTA provided an evidence-based evaluation of genetic tests and offers a firm scientific background for the decision-makers to consider the implementation of a screening for Cystic Fibrosis carriers into the Italian health care system.

The early benefit assessment of drugs was introduced in Germany with the ‘Act to Reorganize the Pharmaceuticals’ Market in the SHI’ (AMNOG) in 2011. Before submitting the manufacturer's dossier, optional scientific advice is offered by the Federal Joint Committee (G-BA). The objective was to elicit manufacturers experience with the scientific advice offered by the Federal Joint Committee.

To prepare the survey, several manufacturers were interviewed on their experience with the scientific advice offered by the Federal Joint Committee. Subsequently, a questionnaire was developed to collect information for this purpose, comprising eight items on different topics aimed at understanding the perceived quality of the scientific advice provided.

The qualitative part comprised seven manufacturers who had received between one and ten advisories before the end of 2012. With regard to the quantitative elicitation part, a total of sixty-one completed questionnaires from nineteen manufacturers were included until the beginning of 2015 (corresponding to almost 25 percent of the overall implemented scientific advice). Fourteen cases were about so called “early” scientific advice in terms of relating to evidence before commencing phase-III trials, forty-four cases concerned “late” scientific advice (pivotal trials were just conducted or already terminated), another two concerned repeated scientific advice and finally, four referred to miscellaneous contents (multiple answers possible). Both, the preceding qualitative and the following quantitative part of the elicitation, highlighted points about the process as well as the content shortcomings from an industry's point of view: inconsistencies, lacking expertise with conducting clinical trials, partially incomplete answers and a low readiness to engage in dialogue were criticized. On the other hand, the majority of respondents showed a positive attitude concerning unambiguousness, completeness, traceability, atmosphere and the protocol of the advice. Over the course of time, propositions on study design, agreement with the determined appropriate comparative therapy and subgroup definitions improved significantly.

A more active involvement of further stakeholders and the incorporation of procedural elements from other health are systems with longer experience could improve the scientific advice provided.

In the age of limited resources, hospital managers confront the need to strictly balance resource allocation at their disposal between drugs, wages, purchases and operation costs. This entails an endless search for creative pathways to efficiently merge the trends to preserve the environment.

A “green” hospital is an entity that is planned, built and operated so as to minimize the ‘ecological footprint’: for example, saving energy by utilizing natural light; recycling water, paper or waste; and using insulation and soundproofing (1).

‘Evidence-based environmental design’, a new approach to advanced building techniques, is gaining momentum worldwide. It synergizes with additional trends: promoting quality, improving potential utility, raising the accountability of hospital workers and involving the public and patients in overcoming health system dilemmas.

The aim was to analyze the standpoints of professionals in health and architecture regarding environmental accountability, in comparison to public opinion, and enhance the dialogue between these three groups to create wise decision making toward improvements in the health system.

A structured questionnaire was prepared to examine environmental responsibility, focusing on hospital contours. The questionnaire was distributed among three groups to be completed anonymously: hospital employees (physicians and medical managers), professionals from the field of architecture and the general public. The distribution was via the internet and to the general public through a social network using the “snowball” mechanism.

Distribution of the survey raised debates on the subject. We compared the views of 178 respondents (80 healthcare professionals, 47 from the field of architecture and 51 from the general public). Demographic and other criteria included age, gender, profession, priority setting, concepts of environmental responsibility and social values. Physicians prioritized economic factors as the main barrier (more than architects or the general public) and marked internal incentives as key factors. Environmental responsibility correlated with high quality of care and service among healthcare workers.

Logistics and physical infrastructure interventions can enhance economic effectiveness. Moreso, they can initiate social and environmental responsibility and increase the level of confidentiality regarding the accountability of their managers towards quality-targeted work surroundings.

It is vitally important that research questions posed are important and that funded research meets a research need or a gap in evidence; these needs may be observed at a local, national or international level. Identifying such research priorities for a national research funder can be challenging, particularly for complex health problems such as health inequalities, where there is a need to consult a large number of experts with a range of expertise. Many methods are used in the identification of such research priorities, however, these can be resource intensive, costly, and logistically challenging particularly where large numbers of people are required and geographical distances are great.

This study investigated the use of Delphi type survey methods in identifying important research priorities related to health inequalities. Public health professionals with an interest in health inequalities were asked to identify research priorities, these research priorities were subsequently compared to those identified using different methods.

Fifty-two public health professionals agreed to take part, the response rates were high, (69 percent, 50 percent and 40 percent) across three survey rounds; which indicated that participants were receptive to the methodology and motivated to respond. The themes identified as encompassing the most important research priorities were: mental health, environmental issues and health behaviours. Within these themes, topic areas which emerged most strongly included: community interventions for prevention of mental health problems, and the food and alcohol environment.

Delphi type survey methods are effective as a means of obtaining opinions from a wide number of relevant experts identifying potential priority topic areas where there is a need for research evidence. Opinions may be sought at local and national levels in order to inform national research priorities.

Health Technology Assessments (HTAs) and policy papers are generally written in academic style using industry jargon — pharmaceutical, medical, or scientific terminology — with a generous use of abbreviations. Transforming technical or biomedical data into easily understandable text is a necessity and a challenge for all of us if our goal is to facilitate HTA collaboration beyond borders and integrate HTA into healthcare practice. Many countries have legislated for plain language (PL), and organizations globally are beginning to recognize how it helps in the uptake of information, whether geared to healthcare professionals and all those interested in HTA, or the lay public.

A preliminary, informal online search for legislative and supporting guidance on PL was conducted, and a query sent out to forty-eight International Network of Agencies for Health Technology Assessment (INAHTA) members.

• • The United States Plain Writing Act of 2010 has legislated that federal agencies use “clear Government communication that the public can understand and use” (1). Of the twenty-one respondents from INAHTA Listserv, seven use plain language in either their knowledge transfer tools (such as executive and research summaries, booklets and fact sheets, and patient or lay material).

• • The Government of Canada promotes plain language in all of its communications (2).

• • McMaster University's 2014 Health Forum on strengthening public and patient engagement in HTA in Ontario supported “clarity and consistency in the use of public- and patient-engagement terminology” in HTAs.

• • A growing number of international health-related and HTA organizations promote PL in their reports and HTAs to help with their health literacy.

• • Many pharmaceutical companies encourage PL communication in their writing (3).

• • Of the eighteen INAHTA responses received, eight reported that they use PL in their report summaries, knowledge transfer materials, and/or patient education tools.

Adopting the practice of clear, straightforward writing and editing in all biomedical communication — including HTAs and journal articles — encourages interaction and engagement among patient, public, and healthcare stakeholders invested in HTAs, and their desire to have measured decision making based on comprehensive, informed, and easily understandable information. However, it remains to be seen if PL will be embraced by organizations worldwide. This preliminary, informal inquiry as to its use suggests that the adoption of PL by governments, HTA organizations, and the scientific community worldwide has not yet been fully embraced.

Within the Brazilian Health System, Referral Centers (RCs) are care facilities that provide specialized services. The objective of this study was to evaluate the efficacy of care provided to patients with multiple myeloma (MM) at a specialized Referral Centers (Hospital de Clínicas de Porto Alegre Referral Center for Multiple Myeloma, CRMM-HCPA) and to compare quality of life between patients with MM treated at CRMM-HCPA and those treated at non-RC facilities.

A 6-month cohort study was conducted in patients with MM receiving thalidomide from the State Health Department and treated at CRMM-HCPA, and patients receiving treatment at other non-RC facilities. Thirty-two patients were included in the study, nineteen from CRMM-HCPA and thirteen from other institutions. To analyze the efficacy of care provided at CRMM-HCPA, the main outcome measure was the time from diagnosis to referral for autologous hematopoietic stem cell transplantation.This outcome measure was assessed using questionnaires specifically designed for this study. Quality of life was also assessed, using the Short-Form 36 Item Health Survey (SF-36) questionnaire.

Time from MM diagnosis to referral for autologous hematopoietic stem cell transplantation in each group was measured only in patients aged 65 years (n = 25); of these, 15 were recruited from CRMM-HCPA and 10 from other institutions. In this analysis, there was a significant difference (p = .036) in time elapsed between diagnosis and referral for autologous hematopoietic stem cell transplantation, which was significantly shorter for patients treated at CRMM-HCPA (median, 9 months; Interquartile Range, IQR, 8.5–14.5) than for those treated elsewhere (median, 24 months; IQR, 16–24). On quality of life analysis, there was a significant difference in the Social Functioning, which relates to performance of social activities (p = .02).

The Referral Centers model provided seems to be a more efficient treatment strategy as compared with other health care facilities, as it enabled a reduction in time to transplantation. Patients treated at CRMM-HCPA demonstrated greater ease in performing social activities, with less interference from physical or emotional problems.