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.

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.