Disinvestment – stopping the use of health technologies with little or no clinical benefits – can reduce health system costs and change practice towards effective innovations. In England, efforts to support disinvestment have included the National Institute of Health and Care Excellence (NICE's) list of 900+ “Do Not Do (DND) technologies”. However, recent studies show ongoing, varying rates of DND technology, suggesting limited influence. In response, we propose a shift in perspective and reframing of the concept of ‘disinvestment’ to focus on ‘appropriateness’.

We have developed a two-pronged approach to ‘appropriateness’. The first develops local clinician agreements on specific, appropriate indications for a technology. The "RAND/UCLA Appropriateness Method” is being extended in this stage. This knowledge management process enables incorporation of local knowledge and practice via consensus development amongst local experts alongside scientific evidence. The second, and more novel, element is to specify and routinely collect data on technology use associated with these agreed indications. Shifting from cross-sectional clinical audits to real-time monitoring will highlight variation from the agreed indications, which can inform reimbursement policy and decisions. Evaluating the feasibility and sustainability of this approach will provide important lessons for scaling up.

For clinicians, the reframing from disinvestment to appropriateness has important implications. The approach recognizes that there are very few technologies with absolutely no benefit. Framing the management of technology diffusion in terms of appropriateness emphasises benefits and maximises value for public health. Furthermore, combining local agreements on indications with real-time data capture facilitates intelligent, flexible commissioning and informs real-life evaluation.

Shifting the perspective from disinvestment to appropriateness overcomes negative associations of stopping healthcare technologies. Linking clinically driven decisions on technology indications with routine data capture on use can transform clinical audit and healthcare commissioning. The combination of these approaches is, we believe, a novel approach on which more reflection and research will be valuable.

The Innovative Medicines Initiative, IMI-GetReal project aimed to explore incorporation of robust methods for real-world data (RWD) collection and synthesis earlier in the medicines development process, both by pharmaceutical companies and healthcare decision makers. The focus was on the potential use of RWD, alone or in combination with randomized controlled trials (RCTs), to demonstrate effectiveness of new interventions. Four case studies were conducted in multiple disease areas to examine methods for predicting drug effectiveness and the perspectives of different stakeholders on these methods. This study aimed to identify practical obstacles in accessing and using RWD and RCT data for effectiveness research conducted as part of these case studies.

Qualitative content analysis was conducted to identify and characterize key issues relating to accessing and analysing study data from external sources, both RWD and RCTs.

Accessing RWD from registries proved difficult due to multiple reasons, including: complex and non-transparent application procedures, resistance from registry owners to discuss applications and datasets not being research-ready within project timeframes. There were also issues with the RWD eventually accessed, including a lack of individual participant data (IPD) and incomplete data. Where access to IPD from RCTs was obtainable, there were restrictions imposed on how it could be used. For example, it could not be used to target analysis on an individual product, but rather explore methodologies for data synthesis in a product-anonymised setting. This condition encouraged additional data sharing by other stakeholders.

Despite the collaborative, multi-stakeholder nature of IMI-GetReal and proper disclosures with data owners, access to data proved challenging. Such barriers to data accessibility can delay effectiveness research, restrict opportunities for the development of methods incorporating RWD and diminish the potential use of RWD in decision making. Where data is intended to be used for this purpose, sufficient attention should be paid to these potential barriers.

The Italian Medicines Agency Registry represents a tool that could be a precious source of information regarding the mean treatment duration of a drug in a real world context. Monitoring registries are applied at the national level after market authorization and are designed not only to apply the Managed Entry Agreements (MEAs) but also to collect Real World Data on drugs safety, effectiveness and real life utilization. The purpose of this analysis was to compare the treatment duration from clinical trials and the mean treatment duration calculated using data from monitoring registries (1).

For each drug included in the analysis it was collected the treatment duration from Time To Off Treatment curves for the experimental drug (eTTOT) from Phase III clinical trials and the mean treatment duration data calculated by using the number of cycles (converted in months of treatment) of all treated patients extracted from AIFA registries (TTAR). The mean ratios between the Time of Treatment of Italian Medicines Agency and Experimental arm time to off treatment were calculated to identify potential correlations. High level of correlation was expected if Time to Payment By Result /Time To Off Treatment ratio was close to 1 (±.2).

Six Roche products or different indications of the same product were identified as candidates for the analysis from 2013 to 2016. The mean TTAR/eTTOT ratio observed in patients treated from 2013 to 2016 was .97 (±.10), meaning that the mean treatment duration calculated from AIFA Registries is strongly comparable with the treatment duration observed in clinical trials. In one case the TTAR is even more major than eTTOT.

A high level of correlation between TTAR and eTTOT was found. Additional analyses considering different cohorts of patients over time could be useful to have a more precise estimate of real world drug utilization. Even though RCTs remain the gold standard for demonstrating clinical efficacy in restricted trial setting, Real World Evidence from AIFA registries can contribute to the evidence base needed for healthcare decisions.

Generation of high-quality evidence on medical devices through clinical trials can be challenging. The United Kingdom's National Institute for Health and Care Excellence (NICE) has developed a research commissioning framework for producing clinical evidence where gaps in the literature prevent definitive recommendations in their medical technology guidance and diagnostics guidance. The research commissioning framework involves NICE's external assessment centers collaborating with clinical researchers to secure funding and to design, conduct, and publish a study to address research recommendations within 3 years of guidance publications. We aimed to describe the early results of the framework.

Publically available information and results from an informal survey of NICE's external assessment centers were reviewed.

As of December 2016, NICE has published a total of thirty medical technology guidance topics and twenty-four diagnostics guidance topics, five and twenty of which have research recommendations, respectively. A total of fourteen research commissioning framework-facilitated projects have been initiated. Two research projects have successfully secured external funding for a clinical trial: (i) non-contact low frequency ultrasound therapy for wound healing; and (ii) Parafricta bootees for pressure ulcer prevention. Further projects have produced published outputs without external funding. Four projects have been completed and undergone guidance review; one guidance topic was withdrawn and three have been transferred to the “static list”. Early experiences of NICE's research commissioning framework suggest that securing financial support from manufacturers or funding bodies for interventional clinical trials to answer single technology research questions within a short time frame is challenging but possible. The value of early feasibility studies to assess the likelihood of obtaining funding and of addressing NICE's research recommendations was recognised.

NICE can facilitate independent research through its research commissioning framework initiative. Securing funding has proved challenging but recent successes have shown that approach is possible. Outputs which fill the evidence gap to an extent where a definitive guidance update is possible have been rare.

Pulmonary vein isolation (PVI) is a new effective treatment for atrial fibrillation (AF) (1). The standard of care for ablation methods using radiofrequency (RF) is time-consuming and technically challenging (2), and restricted to a few specialized centers, which causes the limited availability of ablation therapy (3). Therefore, cryoballoon (CB) ablation has been developed to shorten and simplify the procedure. The objective of this systematic literature review and meta-analysis was to compare the effectiveness of cryoballoon ablation (CBA) with radiofrequency ablation (RFA) for the treatment of AF.

We searched the Cochrane Library and PubMed from 2009 to October 2016 to screen the eligible literature according to the inclusion and exclusion criteria. The effectiveness measures were the acute pulmonary vein (PV) isolation rate, procedure time, complications and the proportion of patients free from AF (follow-up > 3 months). Meta-analysis and descriptive statistics were used in this study.

A total of seventeen articles with 5,806 cases (2,288 from CBA group, 3,518 from RFA group) from seven different countries were reviewed and analyzed. Pooled analyses indicated that CBA was more beneficial in terms of procedural time (Standard mean difference, SMD = -.501; 95%CI: -.893– -.109; P<.05) for RFA; but the acute PV isolation rate (Odds ratio, OR = .06; 95 percent Confidence Interval, CI: .03–.13; P < .05) in RFA was higher than for CBA; also, after median follow-up of 14 months (range 9–28 months), the proportion of patients free from AF (OR = .965; 95 percent CI:.859—1.085; P = .554) and the total complication rates (OR = .937; 95 percent CI:.753–1.167; P = .562) were not significantly different between CBA and RFA.

In the four randomized controlled trials (RCTs) of the seventeen studies, the proportion of patients free from AF (OR = .951; 95 percent CI:.752–1.202; P = .672) and the complications (OR = 1.521; 95 percent CI:.570–4.058; P = .402) were not significantly different between CBA and RFA.

Overall, compared with RFA for the treatment of patients with AF, CBA had similar clinical effectiveness on the proportion of people free from AF and the number of complications, and yet greater improvement in total procedure time referred for CBA and higher acute PVI rate referred for RFA.

Since the 1990s in France, based on contemporary French consensus conferences, for Hepatitis B (HBV) or Hepatitis C (HCV), diagnosis is acknowledged when detection of Hepatitis B surface antigen or anti-HCV antibody is positive on a 1st test line and further replicated on an independent blood sample.

The replication was introduced to alleviate the low performance of immunoassay and avoid false positive results.

Currently, the Haute Autorité de santé (HAS) is managing an update of diagnostic tests reimbursed for HBV and HCV to fully cover diagnostic needs.

Our aim is to assess the clinical relevance of this repetition.

The assessment involves a critical analysis of national and international guidelines identified by a systematic literature search, and stakeholders’ views (professionals and public authorities).

Since the 1990s, new tools were introduced (that is, polymerase chain reaction (PCR) for diagnosis and follow-up), and performances were improved for both enzyme immunoassay tests and PCR. Despite those change, replications are still performed nowadays in France.

Neither guidelines nor stakeholders’ contributions mentioned any replication tests’ clinical relevance.The Ministry of Health confirms that replications have not any legal basis contrary to HIV diagnosis procedures. Also the French National agency for health products safety confirms there are neither technological pitfalls nor reagent vigilance signals involving HBV or HCV in vitro diagnostic tests. Furthermore, after 1st line positive results, a second blood sample is always collected to test other markers such as HBV DNA or HCV RNA which represent the best 2nd proof of infection.

This work has enlightened a lack of clinical relevance for the replication of the same serological makers’ detection. It may obliterate soon this French medical dogma. This work has illustrated that short assessment based on critical guideline analysis linked with stakeholders’ views allows a rapid answer without assessment quality reduction. This HAS work will contribute to medical practice rationalization and cost reduction.

Knotless barbed sutures can eliminate knot tying during the bariatric surgery (BS) (1). Since effects reported by patients and surgeons are ambiguous, the aim of this study was to establish the safety and efficacy of barbed sutures for intestinal sutures to close the gastrojejunal anastomosis in obese patients undergoing BS.

PubMed, EMBASE, Cochrane Register of Clinical Studies, and ClinicalTrials.gov were searched for randomized controlled trials (RCTs) and cohort studies comparing barbed sutures with conventional sutures in BS (until 30 June 2016). Quality assessment was conducted using to Cochrane recommendations. Review Manager was applied to analyze the data, and we sequentially omitted each study to perform sensitivity analyses.

A total of five cohort studies (low to moderate risk of bias) (n = 859), and no RCTs provided eligible patients. BS includes laparoscopic Roux-en-Y gastric bypass and Laparoscopic sleeve gastrectomy. Comparing to conventional sutures, pooling data showed that suture time (Mean Difference, MD = -5.73, 95 percent Confidence Interval, CI -6.25 to -5.21, P < .01) and operative time (MD = - 7.67, 95 percent CI -10.49 to -4.85, P < .01) decreased significantly in the barbed group. Although the postoperative complications did not suggest significant changes (Odds Ratio, OR = 1.56, 95 percent CI .79 to 3.07, P = .2), the pooling results of hospital stay suggested that a significantly longer duration happened in the barbed groups, despite the fact that there may be only 0.18 day longer. (MD =0.18, 95 percent CI .06 to .29, P = .003).

The barbed suture is an effective and safe surgical technique in BS. More evidence with randomized design, larger sample sizes and longer follow up need to compel validations of this state-of-the-art product in the future (2,3).

Alcohol abuse and addiction lead to a high disease burden for the persons concerned. Moreover, it has economic consequences for society, including costs of health care, costs due to reduced productivity, criminal activities, traffic accidents, and violence, both in private and public domains. The aim of this study was to perform a social cost-benefit analysis (SCBA) of three policy measures (tax increase, reducing number of sales venues, and advertising ban) over a period of 50 years, along with the distribution of costs and benefits among stakeholders (1).

The analysis follows Dutch guidelines for performing SCBAs. Costs and benefits in eight different domains were comprehensively identified. Model simulations were used to estimate future social costs and benefits of three policy measures, compared to not intervening.

Over a period of 50 years, the greatest social benefits were expected from a tax increase. The cumulative discounted net monetary benefit over a period of 50 years is EUR12 billion (95 percent Confidence Interval, CI EUR11-EUR13billion) in the 50 percent tax increase scenario. The net benefits of the other two measures are smaller. The cumulative discounted value to society of a 10 percent decrease in outlet density over a 50-year period amounts to EUR4 billion (range: EUR3 - EUR5 billion). A total media ban with an estimated reduction of 4 percent in alcohol consumption leads to an expected cumulative discounted value to society over a 50-year period of EUR7 billion.

All policy scenarios lead more or less to positive effects for society. The greatest benefits are associated with measures aimed at raising the excise tax on alcohol. Estimations as made in this study may serve to inform alcohol policy in the Netherlands.

Urothelial Bladder Cancer (UBC) is the ninth worldwide most common cancer. In Italy the prevalence of the disease is about 10 percent, representing the third most prevalent cancer with 180,775 cases in men and 42,757 cases in women. The increase in the incidence requires continuous surveillance and care, resulting in a significant burden on Italian Healthcare System, making any improvement to the strategy for diagnosing and treating this disease important to the medical and scientific community. The aim of this study was to evaluate the burden of UBC in the Italian context, collecting and measuring the total costs of the disease.

An economic analysis in the National Health Service perspective was carried out, evaluating in six centers direct costs in terms of outpatient, inpatient and emergency care, pharmaceuticals and follow up procedures and indirect costs in terms of productivity losses. Data were collected through aggregated form reports, focusing on patients with an existing diagnosis of UBC who were taken in charge in the last year. Statistical analysis was conducted in order to explore variations between centers.

Mean total annual cost per patients was EUR11,310, increasing for disease severity from EUR6,954 for superficial disease to EUR24,896 for metastatic stage. The analysis confirmed a proportional relation between disease severity and disability grade. The total burden of the disease considering all patients, including prevalence and incidence data coming from AIOM guidelines 2015, was EUR2,833,655,822, of which 15 percent is represented by estimated productivity losses.

Our analysis represents the first economic burden study of UBC in the Italian context as well as the first real life evidence of the current therapeutic algorithm. This study opens the possibility for further analysis on the indirect costs components that represent a great burden for the society, especially for the stages of the disease with high disability grade.

A common approach to one-way sensitivity analysis is to vary inputs by a constant percentage. An alternative is to derive ranges using evidence-based probability distributions from published sources. Our objective was to compare one-way sensitivity analysis results when using these two approaches for a reference case model, along with two additional case studies.

For the reference case, we replicated a published Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) cost-effectiveness Markov model (zidovudine versus zidovudine plus lamivudine in the UK) using TreeAge®. Health states included three HIV/AIDS states and death. We generated one-way sensitivity analyses by varying inputs in two ways: (i) using ±15 percent for all inputs, and (ii) using the 2.5 and 97.5 percentile values of the evidence-based probability distributions for all inputs. Our outcome was the mean difference between lower and upper incremental cost-effectiveness ratios (ICERs) for each variation method for the ten most influential inputs. We assessed the number of inputs with a mean difference between lower and upper ICERs of >10 percent of the deterministic ICER.

The deterministic ICER was GBP7,654/QALY (quality adjusted life year) for combination therapy versus monotherapy. The mean difference in ICER uncertainty for the evidence-based vs. ±15 percent variation method was GBP3,251/QALY (p = .0096). Six inputs had a mean difference in ICER uncertainty of >10 percent of GBP7,654/QALY (that is, mean difference in ICER uncertainty > GBP765) for the evidence-based variation method, compared to only two inputs for the constant percentage variation method.

For the reference case, the magnitude of uncertainty in the outcome was larger for the evidence-based variation method compared to the constant percentage variation method. Evidence-based uncertainty in inputs should be used in all sensitivity analyses to reflect realistic uncertainty in an outcome and aid decision-making about future research strategies. Additional case studies will be presented using validated models in diabetes and asthma.

Emergency admissions to hospital are a major financial burden on health services. In one area of the United Kingdom (UK), we evaluated a predictive risk stratification tool (PRISM) designed to support primary care practitioners to identify and manage patients at high risk of admission. We assessed the costs of implementing PRISM and its impact on health services costs. At the same time as the study, but independent of it, an incentive payment (‘QOF’) was introduced to encourage primary care practitioners to identify high risk patients and manage their care.

We conducted a randomized stepped wedge trial in thirty-two practices, with cluster-defined control and intervention phases, and participant-level anonymized linked outcomes. We analysed routine linked data on patient outcomes for 18 months (February 2013 – September 2014). We assigned standard unit costs in pound sterling to the resources utilized by each patient. Cost differences between the two study phases were used in conjunction with differences in the primary outcome (emergency admissions) to undertake a cost-effectiveness analysis.

We included outcomes for 230,099 registered patients. We estimated a PRISM implementation cost of GBP0.12 per patient per year.

Costs of emergency department attendances, outpatient visits, emergency and elective admissions to hospital, and general practice activity were higher per patient per year in the intervention phase than control phase (adjusted δ = GBP76, 95 percent Confidence Interval, CI GBP46, GBP106), an effect that was consistent and generally increased with risk level.

Despite low reported use of PRISM, it was associated with increased healthcare expenditure. This effect was unexpected and in the opposite direction to that intended. We cannot disentangle the effects of introducing the PRISM tool from those of imposing the QOF targets; however, since across the UK predictive risk stratification tools for emergency admissions have been introduced alongside incentives to focus on patients at risk, we believe that our findings are generalizable.

Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) are rare cancers most often found in the gastrointestinal system or the pancreas. However, patient-reported health state utilities based on clinical trials have not been previously reported in this disease area.

The CLARINET study collected the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 data from patients in both stable and progressive disease states, although data for the latter were only available during the early stage of progression due to trial design. Using published algorithms, data were mapped to EQ-5D utility values. Random-effects generalized least squares models were used to investigate the impacts of progression status, tumour site and other patient characteristics on mapped utility values.

In total, 1,053 observations from 204 patients were mapped to EuroQol (EQ-5D) utilities using the McKenzie mapping algorithm. The final random-effects model included age, gender, baseline utility and progression status as covariates; it was not feasible to investigate time-to-death utility due to a limited number of death in the CLARINET study. Tumour location (midgut versus pancreas) does not seem to affect utility. However, the difference in utilities based on progression status is statistically significant (p<.05) in the base case analysis, and the estimated utilities for stable and progressive disease are .776 and .726, respectively. Furthermore, scenario analyses showed that utility for progressive disease is numerically lower than for stable disease, but this may not be statistically significant in some scenarios.

Patients with GEP-NETs experience worse utility values in the progressive disease state compared to the stable disease state, based on patient-reported health-related quality of life (HRQL) data from the CLARINET study. The decline of utility in the progressive disease state may be underestimated because progressive HRQL data were only collected shortly after the progression event in the trial. The estimated trial-based utilities can be used in future economic evaluations for GEP-NET treatments and to provide more insights to physicians on patient-reported quality of life outcomes in GEP-NETs.

Increasing access to surgical care is crucial in improving the general health status of a population. Despite studies indicating the cross-country differences of general health indicators, there is a scarcity of knowledge focusing on the cross-country differences of surgical indicators. This study aims to classify countries according to surgical care indicators and identify risk predictors of catastrophic surgical care expenditures.

For this study, data were used from the World Health Organization and the World Bank on 177 countries. The following variable groups were chosen: total density of medical imaging technologies, surgical workforce distribution, number of surgical procedures, and risk of catastrophic surgical care expenditures. The k-means clustering algorithm was used to classify countries according to the surgical indicators. The optimal number of clusters was determined with a within-cluster sum of squares and a scree plot. A Silhouette index was used to examine clustering performance, and a random forest decision tree approach was used to determine risk predictors of catastrophic surgical care expenditures.

The surgical care indicator results delineated the countries into four groups according to each country's income level. The cluster plot indicated that most high-income countries (for example, United States, United Kingdom, Norway) are in the first cluster. The second cluster consisted of four countries: Japan, San Marino, Marshall Islands, and Monaco. Low-income countries (for example, Ethiopia, Guatemala, Kenya) and middle-income countries (for example, Brazil, Turkey, Hungary) are represented in the third and fourth clusters, respectively. The third cluster had a high Silhouette index value (.75). The densities of both surgeons and medical imaging technology were risk determiners of catastrophic surgical care expenditures (Area Under Curve = .82).

Our results demonstrate a need for more effective health plans if the differences between countries surgical care indicators are to be overcome. We recommend that health policymakers reconsider distribution strategies for the surgical workforce and medical imaging technology in the interest of accessibility and equality.

There are several methods to cost hospital contacts when estimating the cost effectiveness of a new intervention. In England, the National Insitute for Health and Care Excellence (NICE) recommends the use of diagnosis-related group (DRG)-based costs as a valuable way of costing hospital resource use. There are three main sources of unit costs of a DRG: (i) tariffs as used for reimbursement purposes, (ii) benchmarking finished consultant episode (FCE)-level reference costs and (iii) benchmarking spell-level reference costs.

The purpose of this work is to compare the implications of choosing a particular source of DRG-based unit costs when conducting an economic evaluation.

As a case study, we used a cost-utility model developed to compare secondary fracture prevention models of care for hip fracture patients (1). A Markov model was derived from large primary and hospital care administrative datasets in England. Utilities were informed by a meta-regression of thirty-two studies. Hospital resource use (inpatient, outpatient, critical care and emergency care) was valued using the three different 2014–15 DRG-based unit costs and regression-based costing models were derived from 33,000 hip fracture patients to inform the health states of the model (2). For each source of DRG-based costs, we calculated mean life years, Quality-Adjusted Life Years (QALYs) and costs for a representative male and female associated with three models of care: (i) orthogeriatrician (OG)-led, (ii) nurse-led fracture liaison services and (iii) usual care.

Using the benchmarking FCE-level DRG-based costs, the OG-led model was estimated to be the most effective model of care (1.77 QALYs, 95 percent Confidence Interval, CI 1.56-1.98) at a threshold of GBP30,000/QALY. However, it also resulted in the highest costs per patient. We will report the cost-effectiveness results using the two remaining DRG-based costs.

Choosing a particular hospital costing method may have an impact on economic evaluations. We will reflect on the implications for the estimated hospital costs, decision uncertainty and adoption of models of care.

In formulating criteria for Health Technology Assessment (HTA) and priority setting a number of such criteria have been suggested and are used, for example in multi-criteria decision making. Besides taking central aspects like severity of disease, effectiveness, cost-effectiveness and patient safety into account, we also find references to criteria like unmet needs, and lack of alternative treatment. Often these criteria are treated as on par with each other, only given different weights in decision making. However, it seems like there is a conceptual overlap between some of these criteria and if that remains unnoticed, there is a risk of taking the same criteria into account twice. One such example is the relationship between severity of disease and unmet need. The aim of this presentation is to present a tentative analysis of the relationship between severity of disease and unmet need.

The presentation is based on a conceptual and normative analysis.

First it will be argued that we have reason to clarify what is meant by unmet needs, whether it is a need which is not met to any degree or if it is a need for which there is no treatment with curative intent or for which there is only palliative treatment, for example. Second, analyzing unmet needs in relation to severity, a number of different scenarios will be examined, showing that unmet needs can be captured in terms of severity of disease (to some extent dependent upon how we operationalize severity of disease).

The general conclusion of the study is that we have reason to carefully analyze criteria used for decision making in HTA from a conceptual and normative perspective in order to uncover logical relationships and avoid overlapping criteria. In relation to the specific question of unmet needs versus severity of disease, the conclusion is that in most cases unmet need will be redudant in relation to severity and we should be careful using both of them in decision making unless we can provide reasons for why it is an exceptional case.

The objective was to identify the conceptual and methodological issues surrounding integration of ethics in Health Technology Assessment (HTA). We conducted a systematic review examining: (i) social needs, (ii) methodological and procedural barriers, (iii) concepts or processes of ethics assessment used and (iv) results of experimentations for integrating ethics in HTA.

Search criteria included ‘ethic’, ‘technology assessment’ and ‘HTA’. The literature search was done up to 21 November 2016 in Medline/Ovid, SCOPUS, CINAHL, PsycINFO and international HTA Database. Screening of citations, screening of full-text and data extraction were performed by two subgroups of two independent reviewers. The first group was constituted of HTA experts, and the second of ethics and philosophy experts. Data extracted from articles were regrouped in categories for each objective.

A list of 2,420 citations was obtained while 1,646 remained after the removal of duplicates. Of these, 132 were fully reviewed, yielding 67 eligible articles for analysis. Eight categories were identified within the social needs. The mostly evoked were ‘Informed policy decision making’ (n = 16) and 'Informed public/patient decision making’ (n = 12). Ten categories of methodological and procedural barriers were identified. The most mentioned were 'Lack of standardized and recognized proceedings for ethical analysis’ (n = 28) and ‘Lack of shared consensus on the role of ethical theory and ethical expertise’ (n = 17). Within the concepts or processes of ethics assessment, thirteen categories were identified. The most mentioned were ‘Fairness and Equity’ (n = 12), ‘Beneficence and Non-maleficence’ (n = 10) and, ‘Autonomy’ (n = 10). Within results of experimentations, five categories were identified. The most mentioned was ‘Usefulness of ethics for identifying relevant problems’ (n = 3). While few experimentations were identified, no clear operational method was found in our research.

This study confirms the necessity to design an operational method integrating ethics and addressing social needs of HTA. Our results constitute the basis for developing a new theoretical and practical method.

This paper is based on a narrative review to identify and describe approaches to incorporate ethical aspects in Health Technology Assessment (HTA). On the first decade HTA was being established as a new area of research, the social and ethical dimensions seemed to play an essential role. This perspective, centered on the social impact of technology contrasts with the current definition, which focuses on the technical conditions of technology, especially properties and effects. Some authors have discussed the obstacles to include the ethical dimension into this area to a large extent. Those authors were motivated by the perception that there are few sections explicitly dedicated to these dimensions in the evaluation reports.

We searched these scientific databases: Pubmed, Cochrane Library, Centre for Review and Dissemination (CRD), PDQ - Evidence and Virtual Health Library (VHL), and selected studies that presented procedures and methodologies for the inclusion of ethical analysis in HTA.

A total of 308 articles were retrieved, nine of them were included. The identified methods were classified into four groups according to the parameters and procedures: (i) normative-based evaluation, (ii) case comparison-based evaluation; (iii) predefined questionnaire application-based evaluation and iv) debate and deliberation-based evaluation.

The result showed a great diversity of approaches (1 - 3) for the inclusion of the ethical dimension in the evaluation studies of health technologies, which can even be used together. It is suggested that its use considers the characteristics and needs of each different application contexts.

This work presented as methodological base of approaches for the integration of the ethical dimension in the HTA field. Nonetheless, the proposed approaches to the incorporation of philosophical field of ethics into the systematization and objectivity field of the HTA reveal a considerable approach diversity that is applied productively. Since it has been agreed that technology evaluation is contextual, different approaches would help to meet the needs for possible adjustment.

Human enhancement technologies need assessments, but they differ from other health technologies. Therefore we may need other methods for their assessment, also with regard to addressing its ethical issues. The objective of this paper is to describe the elaboration of a method for exposing and elucidating ethical issues with human cognitive enhancement. The approach is elaborated in order to support and facilitate open and transparent deliberation and decision making with an emerging type of technology with great potential and formative implications for individuals and society.

The literature search identified relevant approaches. Conventional content analysis of the identified papers and methods revealed their suitability for assessing human cognitive enhancement. Four selection criteria were applied and followed by method development. Pilot testing on smart-glasses (1) resulted in amendments.

A method for exposing and elucidating ethical issues in the assessment of human cognitive enhancement technologies was developed based on three existing approaches in Health Technology Assessment (HTA) (2). The method consists of six steps and a guiding list of forty-three questions. An overview of the approach will be presented.

A method for exposing and elucidating ethical issues in the assessment of human cognitive enhancement has been developed. The method paves the way for context specific ethical assessment and analysis of a new and emerging type of technology.

While “how to perform” a rigorous Health Technology Assessment (HTA) at the institutional level is well established (1), very little has been experienced for empirically approaching an HTA in hospitals: no scientific evidence is available concerning the correct organizational model, to maximise and to improve the functioning, the performance and the effectiveness of the HTA units (2).

This study aims at crystallizing those design options that may positively contribute to the HTA units’ effectiveness (quality) and/or to the efficiency (timely) (3).

After the collection of qualitative data from ninety-five healthcare professionals by means of ad hoc questionnaires and interviews, a hierarchical sequential linear regression model was conducted to verify the existence of HTA units determinants. Size, multidisciplinary, trust among members, HTA previous skills and organizational support were the variables investigated, determining team performance.

A greater size and the presence of different specialities within the working unit positively influenced effectiveness, even if they spent more time to complete the assessment. Trust, previous HTA skills and organizational support played a key role in team performance. Size and previous HTA skills most explained the variance of team effectiveness (R2 = .317; Adjusted R2 = .249). The five investigated variables presented a higher explanatory nature regarding team efficiency (R2 = .246; Adjusted R2 = .165).

The study suggested the creation of multi-dimensional and multi-disciplinary HTA units to increase their effectiveness. HTA units should be monitored by the hospital management board, because an excessive increase in multi-disciplinary and size could determine inefficiency. Trust within members and the attendance of HTA training course improve performance. According to these results, the study gave solutions both to the scholars of HTA and to hospitals strategic management boards, paving the way to the determination of a more efficient and effective HTA units composition.

The purpose of the study was to gather evidence on safety and overall effectiveness of performing laparoscopic surgery by using 3D versus 2D display systems in a variety of pediatric surgical procedures in order to efficiently support the final investment decision on the video system to be acquired.

A new methodology, that is, Decision-oriented HTA (DoHTA) (1) was applied to assess the technology on clinical, technical, organizational, economic, social, ethical and safety domains. A decision-tree covering all the relevant assessment aspects of 3D systems has been derived and weighted following the Analytic Hierarchy Process. Afterwards, another pairwise comparison list was set up to compare both alternative technologies with respect to every lowest indicator.

DoHTA results of the 3D system has mainly forecast its impact on clinical efficacy and productivity within the specific context of use. The 3D system is particularly suitable in reducing the mean error rate, thanks to the stereoscopic depth cues which are lost in 2D vision (2,3) From the technical perspective, the analyses have indicated the reduction in median instrument path length, an enhancement of median motion smoothness, and the decrease in grasper frequency with the 3D display. However, the comparative cost analysis has pointed out that the 3D procedure cost was higher that its comparator.

The assessment of the 3D visual system seems to reasonably satisfy the criteria of feasibility, clinical effectiveness and safety. However, the adoption of the 3D display system in surgical practice could involve increased hospital costs, mainly because of the initial cost of the technology. Indeed, based on the appreciation of the results of DoHTA, especially taking into account the positive technical and clinical features, we conclude that the 3D system may be a good alternative to the 2D system.