Search

Influenza vaccination can benefit most populations, including adults ≥ 65 years of age, who are at greater risk of influenza-related complications. In many countries, enhanced vaccines, such as adjuvanted, high-dose, and recombinant trivalent/quadrivalent influenza vaccines (aTIV/aQIV, HD-TIV/HD-QIV, and QIVr, respectively), are recommended in older populations to provide higher immunogenicity and increased relative vaccine efficacy/effectiveness (rVE) than standard-dose vaccines. This review explores how efficacy and effectiveness data from randomized controlled trials and real-world evidence (RWE) are used in economic evaluations. Findings from published cost-effectiveness analyses (CEA) on enhanced influenza vaccines for older adults are summarized, and the assumptions and approaches used in these CEA are assessed alongside discussion of the importance of RWE in CEA. Results from many CEA showed that adjuvanted and high-dose enhanced vaccines were cost-effective compared with standard vaccines, and that differences in rVE estimates and acquisition price may drive differences in cost-effectiveness estimates between enhanced vaccines. Overall, RWE and CEA provide clinical and economic rationale for enhanced vaccine use in people ≥ 65 years of age, an at-risk population with substantial burden of disease. Countries that consider RWE when making vaccine recommendations have preferentially recommended aTIV/aQIV, as well as HD-TIV/HD-QIV and QIVr, to protect older individuals. [ABSTRACT FROM AUTHOR]

Introduction: The Spanish network of health technology assessment (HTA) agencies (REDETS) is a collaboration of eight agencies, units and services, commissioned by the national and regional governments. The network coordinates work within a common methodological and work framework, guided by the principles of mutual recognition and cooperation. In 2016, a common self-assessment quality tool was developed for the implementation of an overall Quality Management System. Currently we are working on the second step that deals with actions about management, joint activities as a network, and organizational aspects of the network. Methods: A structured search strategy in the main electronic databases and a manual search in websites of networks national and international agencies were carried out in June 2017, in order to gather previous knowledge and developed standards. Through the information included in this review, and with the collaboration of all members, a group of standards for REDETS was developed. Finally, standards proposed were discussed in a face-to face meeting until an agreement was reached. Results: A proposal of 31 standards was put forward taking all the collected information. The aim of each standard was defined, and its level of compliance was specified. Those standards were grouped under nine quality criteria structured in four dimensions: (i) Responsibility and Resources, (ii) Performance and Membership, (iii) Procedures, and (iv) Relations. Conclusions: Based on the gathered information and the agreement of the all members, we developed a toolkit embracing a group of standards for the joint activities within the Spanish Network, network administration and management. It is a complementary instrument of the previous self-evaluating tool, following the establishment of an overall quality management system and under the philosophy of continuous improvement processes. [ABSTRACT FROM AUTHOR]

INTRODUCTION:The Spanish National Network (REDETS) is a group of eight agencies, units and services, depending on National and Regional Governments that coordinate their work within a common methodological framework, guided by the principles of mutual recognition and cooperation. The necessity of considering a Quality Management System has been detected and, consequently, a common tool for all the members needs to be developed. We describe in this study the process to achieve that goal.METHODS:Based on both a review of previous literature and the proposal for a self-evaluating tool, a group of experts from each agency through consensus have developed a tool for self-evaluation in Health Technology Assessment (HTA) agencies. Through the structure described in the handbook of the Andalusian Agency for Healthcare Quality (ACSA), each standard should have a statement or proposal that needs to also include evidence or good practices, and the corresponding evaluation questions. In separate workgroups, the definition of these proposals, evidence and evaluation questions were developed. One face-to-face meeting and two meetings via teleconference were necessary to achieve a final document with all the quality standards.RESULTS:From a proposed structure of sixty-six standards, the titles, definitions, statements and evidence as well as good practices and evaluation questions were established in workgroups with consensus among all of the members (1 - 3). The final version of the self-assessment tool was composed of sixty-eight standards, grouped in twelve quality criteria structured in four dimensions: I Responsibility, II Clients and Stakeholders, III Production Process, and IV Resources.CONCLUSIONS:Quality management requires an evaluation tool and this version, based on a systematic review and consensus, is a useful and practical instrument for developing a handbook by each member of REDETS. An online version of the tool is in process of development. [ABSTRACT FROM AUTHOR]

INTRODUCTION:The Spanish Network of Agencies for Health Technology Assessment (REDETS) is a group of eight agencies, units and services, depending on National and Regional Governments that coordinate their work within a common methodological framework, guided by the principles of mutual recognition and cooperation. In this work, guided by the necessity of implementing a Quality Management System, we present the process to achieve this objective.METHODS:As an initial step, a review was carried out based on a structured search strategy in the main electronic databases Medline and EMBASE, and a manual search in websites of national and international agencies (March 2016) in order to collate previous knowledge and experiences. Through the information included in this review, a proposal to create a quality, self-evaluating tool is necessary.RESULTS:In total, 800 references were found and finally 6 studies were included in the review (1-3). All had a similar structure. Some lists of good practices, classified in dimensions related to different quality aspects in Health Technology Assessment (HTA) organizations, were found. Also some information about questions for evaluating quality standards was indicated. Taking all this information, a proposal of sixty-six standard titles was put forward. These standards were then grouped into twelve quality criteria structured in four dimensions: I Responsibility, II Clients and Stakeholders, III Production Process and IV Resources.CONCLUSIONS:Based on the systematic review, we developed a proposal for a self-evaluating tool and this is the baseline for a common Quality Management System for the Spanish Network of HTA Agencies. The quality management process will require the development of a handbook by each member of REDETS that will be based on agreed quality standards. [ABSTRACT FROM AUTHOR]

Background: Tigecycline is indicated for the treatment of complicated skin infections, soft tissue and intraabdominal infections. Its use could be extended to community-acquired pneumonia (CAP) and hospital pneumonia (HN). The objective was to evaluate the efficacy and safety of tigecycline in the treatment of respiratory infections., Methods: systematic review (2012). Databases used were MEDLINE, EMBASE, Cochrane Library, CRD and WOK. We identified clinical trials of adults with respiratory infection, treated with tigecycline. The quality of the studies was assessed using CASPe checklist., Results: We selected four clinical trials of high-moderate quality. Three studies with patients with CAP and a trial with HN patients. In patients with CAP, efficacy of tigecycline (88.6 to 90.6%) was higher than levofloxacin (85.3 to 87.2%). The non inferiority testing was statistically significant (p < 0.001). In the study of patients with HN tigecycline showed an efficiency of 67.9% versus 78.2% for imipenem/cilastatin. Main adverse effects were gastrointestinal., Conclusions: The efficacy of tigecycline is non inferior than levofloxacin in patients with CAP, but less than imipenem in patients with HN. Tigecycline demonstrates noninferiority versus others tested antibiotics, and it shows a good safety profile.

Background and Objective: This is a safety and cost comparison study with an analysis of budgetary impact of ambulatory management of patients with cancer and deep vein thrombosis (DVT) compared with hospital management., Material and Methods: Prospective observational study of patients with known malignancy and diagnosed with DVT from 2003 to 2007. The outcome variables were mortality, relapse and bleeding in one month. We conducted an economic analysis to evaluate the comparative cost of ambulatory patients., Results: Three hundred and seventeen patients, 55 (17%) had cancer. The mean age of patients was 63 ± 11 years. There were 2 hemorrhagic events, 2 recurrences and 6 deaths in one month of follow-up. Of all patients, only 7 (13,7%) required hospitalization. All but one deaths were due to progression of the underlying disease. Economic analysis concluded that outpatient management is 6 times less expensive than hospital management, which would imply a cost reduction of 85%., Conclusions: Specialized outpatient treatment of cancer patients with DVT is safe and could save significant financial resources., (Copyright © 2011 Elsevier España, S.L. All rights reserved.)

The new techniques of molecular biology called "nucleic acid testing" (NAT), enable the detection of particles of viral DNA in hepatitis B, regardless of the disease stage. These NAT techniques increase the sensitivity of screening, so the risk of infection through transfusion could be reduced. The aim of the study was to assess NAT techniques for screening hepatitis B in blood donors. We carried out a systematic review in Medline and Embase databases (2000-2008), as well as INAHTA, Cochrane Library and EuroScan. MeSH terms used were "Hepatitis B", "Blood Transfusion", "Blood Donors", and "Nucleic Acid Amplification Techniques", and free terms as "hepatitis B", "hbv", "nat", "nat-hbv" and "nucleic acid amplification testing". Twelve studies were included, four of them used self-made PCRs, obtaining mixed results, three used Procleix (two samples identified by NAT were HBsAg (-), 0.05% and 0.013%; and the third study with 135 patients who received anti-HBV therapy and had HBsAg (-), showed 80% of positive samples by NAT techniques). Four papers about MPX reported percentages ranging between 0.083 and 0.0015. In the study of diagnostic tests including the two techniques, they showed the same sensitivity. Both NAT techniques, have a good capacity for screening hepatitis B and showed similar results in sensitivity. They may be a significant advance in automation of blood banks and increase the safety of transfused patients.