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BURLINGTON, Mass., Dec. 14, 2016 /PRNewswire/ -- A recently published paper analysing global research collaborations for Network Meta-Analysis (NMA) has placed DRG Abacus1 as the third most prolific consultancy in terms of NMA publications. Network meta-analysis is commonly used to determine the relative efficacy of treatments for a condition and to inform economic decision models to estimate their relative cost-effectiveness. Network meta-analysis is acknowledged as an appropriate methodology to inform economic analyses by HTA agencies world-wide including NICE, the Canadian Agency for Drugs and Technologies in Health (CADTH), Federal Joint Committee (G-BA) in Germany, the French Haute Autorite de la Sante (HAS), and the Pharmaceutical Benefits Advisory Committee in Australia (PBAC), as well as emerging national agencies in Austria, Brazil, Colombia, Cuba, and Ireland. The paper, published in the scientific journal PLOS One, characterised global patterns of published NMAs between 1997 and 2015. The research found that 81% of NMAs identified were published in the last 5 years with the UK leading in terms of the volume of the number of published NMAs. DRG Abacus were one of the first agencies to offer in-house meta-analysis and NMA capabilities to support reimbursement activities globally. We have been conducting robust meta-analyses for over 5 years, in which time we have developed a high level of expertise and established strong academic links with pioneers in the field ahead of much larger global consultancies. "It is great so see that the NMA research at DRG Abacus has been recognized within this social network analysis publication. We continue to work with leading academics to develop NMA methods as part of our thought leadership program and have several exciting projects in the pipeline." "It is gratifying that our pioneering work in the meta-analysis field has been acknowledged in this way and also to see how our statistical offering has expanded even since this publication under Sarah's leadership." To obtain copies of the research papers published by Dr. Sarah Batson and Dr. Stephen Mitchell, or to contact them for further comments, please email Access@TeamDRG.com. Follow DRG on Twitter @DRGInsights and on LinkedIn and keep up with the latest industry news on the DRG Blog. About Decision Resources Group DRG, a subsidiary of Piramal Enterprises Ltd., offers best-in-class, high-value data, analytics and insights products and services to the healthcare industry, delivered by more than 1,000 employees across 17 offices in North America, Europe and Asia. DRG provides the Life Sciences, Provider, Payer and Financial Services industries the data, tools, insights and advice they need to compete and thrive in an increasingly complex and value-based marketplace. decisionresourcesgroup.com. DRG Abacus, part of Decision Resources Group's consulting arm, provides integrated health economics and outcomes research, as well as market access solutions throughout the product life-cycle. We balance scientific rigor with commercial awareness, differentiating ourselves from our competition through innovation, technical excellence and design. 1 Decision Resources Group acquired Abacus International, which is now known as DRG Abacus, in 2012; this paper refers to DRG Abacus as Abacus International.

Sullivan S.D.,University of Washington | Mauskopf J.A.,RTI Health Solutions | Augustovski F.,Institute for Clinical Effectiveness and Health Policy | Jaime Caro J.,Evidera | And 7 more authors.
Value in Health | Year: 2014

Background Budget impact analyses (BIAs) are an essential part of a comprehensive economic assessment of a health care intervention and are increasingly required by reimbursement authorities as part of a listing or reimbursement submission. Objectives The objective of this report was to present updated guidance on methods for those undertaking such analyses or for those reviewing the results of such analyses. This update was needed, in part, because of developments in BIA methods as well as a growing interest, particularly in emerging markets, in matters related to affordability and population health impacts of health care interventions. Methods The Task Force was approved by the International Society for Pharmacoeconomics and Outcomes Research Health Sciences Policy Council and appointed by its Board of Directors. Members were experienced developers or users of BIAs; worked in academia and industry and as advisors to governments; and came from several countries in North America and South America, Oceania, Asia, and Europe. The Task Force solicited comments on the drafts from a core group of external reviewers and, more broadly, from the membership of the International Society for Pharmacoeconomics and Outcomes Research. Results The Task Force recommends that the design of a BIA for a new health care intervention should take into account relevant features of the health care system, possible access restrictions, the anticipated uptake of the new intervention, and the use and effects of the current and new interventions. The key elements of a BIA include estimating the size of the eligible population, the current mix of treatments and the expected mix after the introduction of the new intervention, the cost of the treatment mixes, and any changes expected in condition-related costs. Where possible, the BIA calculations should be performed by using a simple cost calculator approach because of its ease of use for budget holders. In instances, however, in which the changes in eligible population size, disease severity mix, or treatment patterns cannot be credibly captured by using the cost calculator approach, a cohort or patient-level condition-specific model may be used to estimate the budget impact of the new intervention, accounting appropriately for those entering and leaving the eligible population over time. In either case, the BIA should use data that reflect values specific to a particular decision maker's population. Sensitivity analysis should be of alternative scenarios chosen from the perspective of the decision maker. The validation of the model should include at least face validity with decision makers and verification of the calculations. Data sources for the BIA should include published clinical trial estimates and comparator studies for the efficacy and safety of the current and new interventions as well as the decision maker's own population for the other parameter estimates, where possible. Other data sources include the use of published data, well-recognized local or national statistical information, and, in special circumstances, expert opinion. Reporting of the BIA should provide detailed information about the input parameter values and calculations at a level of detail that would allow another modeler to replicate the analysis. The outcomes of the BIA should be presented in the format of interest to health care decision makers. In a computer program, options should be provided for different categories of costs to be included or excluded from the analysis. Conclusions We recommend a framework for the BIA, provide guidance on the acquisition and use of data, and offer a common reporting format that will promote standardization and transparency. Adherence to these good research practice principles would not necessarily supersede jurisdiction-specific BIA guidelines but may support and enhance local recommendations or serve as a starting point for payers wishing to promulgate methodology guidelines. © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Richter T.A.,Canadian Agency for Drugs and Technologies in Health
PLoS ONE | Year: 2014

Clinical research has become increasingly globalized, but the extent of globalization has not been assessed. To describe the globalization of clinical research, we used all (n=13,208) multinational trials registered at ClinicalTrials.gov to analyzed geographic connections among individual countries. Our findings indicate that 95% (n=185) of all countries worldwide have participated in multinational clinical research. Growth in the globalization of clinical research peaked in 2009, suggesting that the global infrastructure that supports clinical research might have reached its maximum capacity. Growth in the globalization of clinical research is attributable to increased involvement of non-traditional markets, particularly in South America and Asia. Nevertheless, Europe is the most highly interconnected geographic region (60.64% of global connections), and collectively, Europe, North America, and Asia comprise more than 85% of all global connections. Therefore, while the expansion of clinical trials into non-traditional markets has increased over the last 20 years and connects countries across the globe, traditional markets still dominate multinational clinical research, which appears to have reached a maximum global capacity. © 2014 Trevor A. Richter.

Kamel C.,Canadian Agency for Drugs and Technologies in Health | McGahan L.,Canadian Agency for Drugs and Technologies in Health | Polisena J.,Canadian Agency for Drugs and Technologies in Health | Mierzwinski-Urban M.,Canadian Agency for Drugs and Technologies in Health | Embil J.M.,University of Manitoba
Infection Control and Hospital Epidemiology | Year: 2012

objective. To evaluate the clinical effectiveness of preoperative skin antiseptic preparations and application techniques for the prevention of surgical site infections (SSIs). design. Systematic review of the literature using Medline, EMBASE, and other databases, for the period January 2001 to June 2011. methods. Comparative studies (including randomized and nonrandomized trials) of preoperative skin antisepsis preparations and application techniques were included. Two researchers reviewed each study and extracted data using standardized tables developed before the study. Studies were reviewed for their methodological quality and clinical findings. results. Twenty studies (n=9,520 patients) were included in the review. The results indicated that presurgical antiseptic showering is effective for reducing skin flora and may reduce SSI rates. Given the heterogeneity of the studies and the results, conclusions about which antiseptic is more effective at reducing SSIs cannot be drawn. conclusions. The evidence suggests that preoperative antiseptic showers reduce bacterial colonization and may be effective at preventing SSIs. The antiseptic application method is inconsequential, and data are lacking to suggest which antiseptic solution is the most effective. Disinfectant products are often mixed with alcohol or water, which makes it difficult to form overall conclusions regarding an active ingredient. Large, well-conducted randomized controlled trials with consistent protocols comparing agents in the same bases are needed to provide unequivocal evidence on the effectiveness of one antiseptic preparation over another for the prevention of SSIs. © 2012 by The Society for Healthcare Epidemiology of America. All rights reserved.

Morrison A.,Canadian Agency for Drugs and Technologies in Health
International Journal of Technology Assessment in Health Care | Year: 2012

Canada has a highly decentralized health care system with 13 provinces and territories delivering health care within their own respective jurisdictions. Decisions regarding which innovative health technologies to adopt are often driven by the unique health care priorities of each jurisdiction's population. To understand these needs, the Canadian Agency for Drugs and Technologies in Health's (CADTH's) Early Awareness Service has expanded its activities. In addition to proactively scanning the horizon for new and emerging health technologies, the Early Awareness Service also scans the horizon for national and jurisdictional health policy issues. This paper looks at CADTH's process for identifying and monitoring policy issues at a national and jurisdictional level. CADTH's Early Awareness Service delivers timely information on emerging health care concerns and technologies that may affect health care finances, facilities, operations, and patient care. The identification of important policy issues can help determine which new and emerging technologies will have the most significant impact on the health care system. The information that CADTH scans can also be used to help decision-makers prepare for potential developments and events that may have an impact on health care systems. By improving its capability to identify and share policy issues across and within jurisdictions, CADTH is better situated to provide information that can be used by policy-makers to help them plan and anticipate for the introduction of new technologies and future developments affecting the unique health care needs of their jurisdictions. © Copyright 2012 Cambridge University Press.

Farrah K.,Canadian Agency for Drugs and Technologies in Health | Mierzwinski-Urban M.,Canadian Agency for Drugs and Technologies in Health
Journal of the Medical Library Association | Year: 2016

Objective: The study tested the performance of adverse effects search filters when searching for safety information on medical devices, procedures, and diagnostic tests in MEDLINE and Embase. Methods: The sensitivity of 3 filters was determined using a sample of 631 references from 131 rapid reviews related to the safety of health technologies. The references were divided into 2 sets by type of intervention: drugs and nondrug health technologies. Keyword and indexing analysis were performed on references from the nondrug testing set that 1 or more of the filters did not retrieve. Results: For all 3 filters, sensitivity was lower for nondrug health technologies (ranging from 53%– 87%) than for drugs (88%–93%) in both databases. When tested on the nondrug health technologies set, sensitivity was lower in Embase (ranging from 53%–81%) than in MEDLINE (67%–87%) for all filters. Of the nondrug records that 1 or more of the filters missed, 39% of the missed MEDLINE records and 18% of the missed Embase records did not contain any indexing terms related to adverse events. Analyzing the titles and abstracts of nondrug records that were missed by any 1 filter, the most commonly used keywords related to adverse effects were: risk, complications, mortality, contamination, hemorrhage, and failure. Conclusions: In this study, adverse effects filters were less effective at finding information about the safety of medical devices, procedures, and tests compared to information about the safety of drugs. © 2016, Medical Library Association. All rights reserved.

Castellucci L.A.,Ottawa Hospital Research Institute | Cameron C.,University of Ottawa | Le Gal G.,Ottawa Hospital Research Institute | Rodger M.A.,Ottawa Hospital Research Institute | And 6 more authors.
JAMA - Journal of the American Medical Association | Year: 2014

IMPORTANCE: Many anticoagulant strategies are available for the treatment of acute venous thromboembolism, yet little guidance exists regarding which drug is most effective and safe. OBJECTIVE: To summarize and compare the efficacy and safety outcomes associated with 8 anticoagulation options (unfractionated heparin [UFH], low-molecular-weight heparin [LMWH], or fondaparinux in combination with vitamin K antagonists); LMWH with dabigatran or edoxaban; rivaroxaban; apixaban; and LMWH alone) for treatment of venous thromboembolism. DATA SOURCES: A systematic literature search was conducted using MEDLINE, EMBASE, and the evidence-based medicine reviews from inception through February 28, 2014. STUDY SELECTION: Eligible studies were randomized trials reporting rates of recurrent venous thromboembolism and major bleeding in patients with acute venous thromboembolism. Of the 1197 studies identified, 45 trials including 44 989 patients were included in the analyses. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted trial-level data including number of patients, duration of follow-up, and outcomes. The data were pooled using network meta-analysis. MAIN OUTCOMES AND MEASURES: The primary clinical and safety outcomeswere recurrent venous thromboembolism and major bleeding, respectively. RESULTS: Compared with the LMWH-vitamin K antagonist combination, a treatment strategy using the UFH-vitamin K antagonist combination was associated with an increased risk of recurrent venous thromboembolism (hazard ratio [HR], 1.42; 95%credible interval [CrI], 1.15-1.79). The proportion of patients experiencing recurrent venous thromboembolism during 3 months of treatment were 1.84%(95%CrI, 1.33%-2.51%) for the UFH-vitamin K antagonist combination and 1.30% (95%CrI, 1.02%-1.62%) for the LMWH-vitamin K antagonist combination. Rivaroxaban (HR, 0.55; 95%CrI, 0.35-0.89) and apixaban (HR, 0.31; 95%CrI, 0.15-0.62) were associated with a lower risk of bleeding than was the LMWH-vitamin K antagonist combination, with a lower proportion of patients experiencing a major bleeding event during 3 months of anticoagulation: 0.49% (95%CrI, 0.29%-0.85%) for rivaroxaban, 0.28%(95%CrI, 0.14%-0.50%) for apixaban, and 0.89%(95%CrI, 0.66%-1.16%) for the LMWH-vitamin K antagonist combination. CONCLUSIONS AND RELEVANCE: Usingmeta-analytic pooling, therewere no statistically significant differences for efficacy and safety associated with most treatment strategies used to treat acute venous thromboembolism compared with the LMWH-vitamin K antagonist combination. However, findings suggest that the UFH-vitamin K antagonist combination is associated with the least effective strategy and that rivaroxaban and apixaban may be associated with the lowest risk for bleeding. Copyright 2014 American Medical Association. All rights reserved.

Husereau D.,Canadian Agency for Drugs and Technologies in Health | Boucher M.,Canadian Agency for Drugs and Technologies in Health | Noorani H.,Canadian Agency for Drugs and Technologies in Health
International Journal of Technology Assessment in Health Care | Year: 2010

Objectives: The aim of this study was to describe a current practical approach of priority setting of health technology assessment (HTA) research that involves multi-criteria decision analysis and a deliberative process. Methods: Criteria related to HTA prioritization were identified and grouped through a systematic review and consultation with a selection committee. Criteria were scored through a pair-wise comparison approach. Criteria were pruned based on the average weights obtained from consistent (consistency index < 0.2) responders and consensus. HTA proposals are ranked based on available information and a weighted criteria score. The rank, along with additional contextual information and discussion among committee members, is used to achieve consensus on HTA research priorities. Results: Six of eleven criteria represented > 75 percent of the weight behind committee member decisions to conduct an HTA. These criteria were disease burden, clinical impact, alternatives, budget impact, economic impact, and available evidence. Since May 2006, committees have considered 102 proposals at sixteen biannual in-person advisory committee meetings. These have selected twenty-nine research priorities for the HTA program. Conclusions: The approach works well and was easy to implement. Feedback from committee members has been positive. This approach may assist HTA and other research agencies in better priority setting by informing the selection of the most important and policy-relevant topics in the presence of a wide variety of research proposals. This may in turn lead to efficiently allocating resources available for HTA research. Copyright © Cambridge University Press 2010.

Post-marketing surveillance (PMS) may identify rare serious incidents or adverse events due to the long-term use of a medical device, which was not captured in the pre-market process. Percutaneous transluminal coronary angioplasty (PTCA) is a non-surgical procedure that uses a balloon-tipped catheter to enlarge a narrowed artery. In 2011, 1,942 adverse event reports related to the use of PTCA catheters were submitted to the FDA by the manufacturers, an increase from the 883 reported in 2008. The primary research objective is to conduct a systematic review of the published and grey literature published between 2007 and 2012 for the frequency of incidents, adverse events and malfunctions associated with the use of PTCA catheters in patients with coronary artery disease (CAD). Grey literature has not been commercially published. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PubMed for medical literature on PMS for PTCA catheters in patients with CAD published between January 2007 and July 2012. We also searched the grey literature. This review included 11 studies. The in-hospital adverse events reported were individual cases of myocardial infarction and hematoma. In studies of patients with coronary perforation, more patients with balloon angioplasty were identified compared with patients who required stenting. Our systematic review illustrates that the volume and quality of PMS studies associated with the use of PTCA catheters in patients with CAD are low in the published and grey literature, and may not be useful sources of information for decisions on safety. In most studies, the objectives were not to monitor the long-term safety of the use of PTCA catheters in clinical practice. Future studies can explore the strengths and limitations of PMS databases administered by regulatory authorities.

Polisena J.,Canadian Agency for Drugs and Technologies in Health | Chen S.,Canadian Agency for Drugs and Technologies in Health | Cimon K.,Canadian Agency for Drugs and Technologies in Health | McGill S.,Canadian Agency for Drugs and Technologies in Health | Forward K.,Dalhousie University
BMC Infectious Diseases | Year: 2011

Background: Methicillin resistant Staphylococcus aureus (MRSA) are often resistant to multiple classes of antibiotics. The research objectives of this systematic review were to evaluate the clinical effectiveness of polymerase chain reaction (PCR) versus chromogenic agar for MRSA screening, and PCR versus no screening for several clinical outcomes, including MRSA colonization and infection rates.Methods: An electronic literature search was conducted on studies evaluating polymerase chain reaction techniques and methicillin (also spelled meticillin) resistant Staphylococcus aureus that were published from 1993 onwards using Medline, Medline In-Process & Other Non-Indexed Citations, BIOSIS Previews, and EMBASE. Due to the presence of heterogeneity in the selected studies, the clinical findings of individual studies were described.Results: Nine studies that compared screening for MRSA using PCR versus screening using chromogenic agar in a hospital setting, and two studies that compared screening using PCR with no or targeted screening were identified. Some studies found lower MRSA colonization and acquisition, infection, and transmission rates in screening with PCR versus screening with chromogenic agar, and the turnaround time for screening test results was lower for PCR. One study reported a lower number of unnecessary isolation days with screening using PCR versus screening with chromogenic agar, but the proportion of patients isolated was similar between both groups. The turnaround time for test results and number of isolation days were lower for PCR versus chromogenic agar for MRSA screening.Conclusions: The use of PCR for MRSA screening demonstrated a lower turnaround time and number of isolation days compared with chromogenic agar. Given the mixed quality and number of studies (11 studies), gaps remain in the published literature and the evidence remains insufficient. In addition to screening, factors such as the number of contacts between healthcare workers and patients, number of patients attended by one healthcare worker per day, probability of colonization among healthcare workers, and MRSA status of hospital shared equipment and hospital environment must be considered to control the transmission of MRSA in a hospital setting. © 2011 Polisena et al; licensee BioMed Central Ltd.

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