scholarly journals Viscoelastic point-of-care testing to assist with the diagnosis, management and monitoring of haemostasis: a systematic review and cost-effectiveness analysis

2015 ◽  
Vol 19 (58) ◽  
pp. 1-228 ◽  
Author(s):  
Penny Whiting ◽  
Maiwenn Al ◽  
Marie Westwood ◽  
Isaac Corro Ramos ◽  
Steve Ryder ◽  
...  

BackgroundPatients with substantive bleeding usually require transfusion and/or (re-)operation. Red blood cell (RBC) transfusion is independently associated with a greater risk of infection, morbidity, increased hospital stay and mortality. ROTEM (ROTEM®Delta, TEM International GmbH, Munich, Germany;www.rotem.de), TEG (TEG®5000 analyser, Haemonetics Corporation, Niles, IL, USA;www.haemonetics.com) and Sonoclot (Sonoclot®coagulation and platelet function analyser, Sienco Inc., Arvada, CO) are point-of-care viscoelastic (VE) devices that use thromboelastometry to test for haemostasis in whole blood. They have a number of proposed advantages over standard laboratory tests (SLTs): they provide a result much quicker, are able to identify what part of the clotting process is disrupted, and provide information on clot formation over time and fibrinolysis.ObjectivesThis assessment aimed to assess the clinical effectiveness and cost-effectiveness of VE devices to assist with the diagnosis, management and monitoring of haemostasis disorders during and after cardiac surgery, trauma-induced coagulopathy and post-partum haemorrhage (PPH).MethodsSixteen databases were searched to December 2013: MEDLINE (OvidSP), MEDLINE In-Process and Other Non-Indexed Citations and Daily Update (OvidSP), EMBASE (OvidSP), BIOSIS Previews (Web of Knowledge), Science Citation Index (SCI) (Web of Science), Conference Proceedings Citation Index (CPCI-S) (Web of Science), Cochrane Database of Systematic Reviews (CDSR), Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment (HTA) database, Latin American and Caribbean Health Sciences Literature (LILACS), International Network of Agencies for Health Technology Assessment (INAHTA), National Institute for Health Research (NIHR) HTA programme, Aggressive Research Intelligence Facility (ARIF), Medion, and the International Prospective Register of Systematic Reviews (PROSPERO). Randomised controlled trials (RCTs) were assessed for quality using the Cochrane Risk of Bias tool. Prediction studies were assessed using QUADAS-2. For RCTs, summary relative risks (RRs) were estimated using random-effects models. Continuous data were summarised narratively. For prediction studies, the odds ratio (OR) was selected as the primary effect estimate. The health-economic analysis considered the costs and quality-adjusted life-years of ROTEM, TEG and Sonoclot compared with SLTs in cardiac surgery and trauma patients. A decision tree was used to take into account short-term complications and longer-term side effects from transfusion. The model assumed a 1-year time horizon.ResultsThirty-one studies (39 publications) were included in the clinical effectiveness review. Eleven RCTs (n = 1089) assessed VE devices in patients undergoing cardiac surgery; six assessed thromboelastography (TEG) and five assessed ROTEM. There was a significant reduction in RBC transfusion [RR 0.88, 95% confidence interval (CI) 0.80 to 0.96; six studies], platelet transfusion (RR 0.72, 95% CI 0.58 to 0.89; six studies) and fresh frozen plasma to transfusion (RR 0.47, 95% CI 0.35 to 0.65; five studies) in VE testing groups compared with control. There were no significant differences between groups in terms of other blood products transfused. Continuous data on blood product use supported these findings. Clinical outcomes did not differ significantly between groups. There were no apparent differences between ROTEM or TEG; none of the RCTs evaluated Sonoclot. There were no data on the clinical effectiveness of VE devices in trauma patients or women with PPH. VE testing was cost-saving and more effective than SLTs. For the cardiac surgery model, the cost-saving was £43 for ROTEM, £79 for TEG and £132 for Sonoclot. For the trauma population, the cost-savings owing to VE testing were more substantial, amounting to per-patient savings of £688 for ROTEM compared with SLTs, £721 for TEG, and £818 for Sonoclot. This finding was entirely dependent on material costs, which are slightly higher for ROTEM. VE testing remained cost-saving following various scenario analyses.ConclusionsVE testing is cost-saving and more effective than SLTs, in both patients undergoing cardiac surgery and trauma patients. However, there were no data on the clinical effectiveness of Sonoclot or of VE devices in trauma patients.Study registrationThis study is registered as PROSPERO CRD42013005623.FundingThe NIHR Health Technology Assessment programme.

2017 ◽  
Vol 33 (S1) ◽  
pp. 56-56
Author(s):  
Bernice Dillon ◽  
John Powell ◽  
Mark Campbell ◽  
Mark Salmon ◽  
Mirella Marlow

INTRODUCTION:The Health Technology Assessment (HTA) of mobile health applications involves significant challenges including rapid product development cycles, sparse evidence and uncertainty over the economic impact. However apps also provide unique opportunities, such as their potential reach and use of real-world data, which will facilitate their contribution to healthcare delivery. The National Institute for Health and Care Excellence (NICE), alongside other agencies, has been piloting the development of a health app assessment programme. This presentation reports the results of a study about the development of the Health App Briefing (HAB) which is designed as the output from a rapid assessment of the effectiveness and cost-saving potential of apps to inform decision makers in the United Kingdom National Health Service.METHODS:The HAB is built on the success of the NICE Medtech Innovation Briefings programme because many of the HTA challenges are similar to those found with medical devices. HAB development is grounded in four principles: rapid assessment; transparent process; independence from industry or the health service and input from commentators. The content includes an evidence summary for effectiveness including comments from specialist experts and users; a summary of information relating to the cost saving potential and a summary of other user benefits (including issues of access and usability). Novel features are the presentation of a rating of the potential value of the app to the health system and working with commissioners of the app to obtain real-world information for a case study about the economic impact.RESULTS:The development of four HABs along with a review of the learning from the piloting process will be presented. The review will include stakeholder feedback from a workshop.CONCLUSIONS:We believe the evaluation of this work presented here will be of interest to other HTA agencies around the world that are deciding how to approach the issues surrounding the assessment of health apps.


2017 ◽  
Vol 33 (S1) ◽  
pp. 168-169
Author(s):  
Francesco Faggiano ◽  
Martina Andellini ◽  
Federico Nocchi ◽  
Carlo Capussotto ◽  
Francesca Sabusco ◽  
...  

INTRODUCTION:The purpose of the study was to evaluate different type and manufacturers of intensive care ventilators in order to support the healthcare decision-making process about the choice to adopt the best available technology for ventilation of pediatric patient in intensive care units at Bambino Gesù Children's Hospital.METHODS:The technology assessment process was developed by using a new methodology, the Decision-oriented Health Technology Assessment (HTA) (DoHTA), a new implementation of the European Network for Health Technology Assessment (EUnetHTA) CoreModel, integrating the Analytic Hierarchy Process (1). A literature review was carried out to gather evidence on safety and overall effectiveness of different kind of intensive care ventilators, with several ventilation modalities and strategies. The synthesis of scientific evidence, and results of the specific context analysis resulted in the definition of components of the decisional hierarchy structure, consisting in detailed characteristics of the technology's performances covering the aspects on feasibility, safety, efficacy, costs, and organizational and technical characteristics of the technology. A subgroup of these indicators has been included in a checklist form for the evaluation of different type and manufacturers of intensive care ventilators, each of which was tested in three independent runs performed in three different departments. In addition, an economic evaluation was also carried out.RESULTS:Preliminary DoHTA results showed that the domains with the highest impacts within the evaluation are safety and clinical effectiveness (34.8 percent and 25.7 percent, respectively) followed by organizational aspects, technical characteristics of technology and costs and economic evaluation. The final objective is to define the alternatives’ ranking through a comparison between alternative technologies’ performances.CONCLUSIONS:The technology assessment project allowed to identify strengths and limits of the most recent intensive care ventilator’ models in the specific contexts of use by involving all health professionals interested, and eventually identify the best option for the hospital.


1998 ◽  
Vol 14 (2) ◽  
pp. 226-236 ◽  
Author(s):  
Wija J. Oortwijn ◽  
Hindrik Vondeling ◽  
Lex Bouter

AbstractPriority setting for the evaluation of health technologies in the Netherlands is exclusively based on the scientific merits of individual research proposals. This process has not resulted in satisfactory allocation of resources. Therefore, societal criteria for setting priorities for health technology assessment have been proposed as an adjunct to scientific criteria. These societal criteria include the burden of disease, uncertainty about the (cost-)effectiveness of the intervention at issue, the potential benefits of the research project, and its potential impact on health care. To realize the full potential of this model for priority setting, a number of methodological issues need to be addressed. Joint efforts of researchers and policy makers in this field are necessary for future progress.


2020 ◽  
Vol 44 (127) ◽  
pp. 1255-1276
Author(s):  
Raquel Lisbôa ◽  
Rosângela Caetano

RESUMO A Avaliação de Tecnologias em Saúde (ATS) respalda políticas públicas na gestão de tecnologias em diversos países. No Brasil, a institucionalização da ATS se iniciou em 2000, no Ministério da Saúde, e contou com a participação da Agência Nacional de Saúde Suplementar (ANS). Contudo, o sistema público e a saúde suplementar trilharam diferentes caminhos. Processos distintos de ATS podem gerar retrabalho, ineficiência e aumentar as inequidades entre o público e o privado. O objetivo desta pesquisa foi identificar a dualidade entre o público e o privado relativa aos modelos de ATS implantados no País. Realizou-se uma revisão de escopo da literatura no período de 2000 a 2019 nas bases de dados Medline, Scopus, Web of Science e Lilacs. Também se realizou análise de documentos da ANS relativos ao processo de ATS na saúde suplementar. A revisão da literatura constatou a escassez de artigos sobre o tema, enquanto a análise documental permitiu traçar uma linha do tempo com os principais marcos referentes ao processo de ATS da Agência. Concluiu-se que a coordenação nacional de um modelo de ATS é desejada, visando a aumentar a transparência das instituições, a maior credibilidade das suas decisões, maior eficiência do processo e proporcionar maior equidade.


Author(s):  
Imma Latessa ◽  
Carlo Ricciardi ◽  
Deborah Jacob ◽  
Halldór Jónsson Jr ◽  
Monica Gambacorta ◽  
...  

The purpose of this study is to use Health Technology Assessment (HTA) through the Six Sigma (SS) and DMAIC (Define, Measure, Analyse, Improve, Control) problem-solving strategies for comparing cemented and uncemented prostheses in terms of the costs incurred for Total hip arthroplasty (THA) and the length of hospital stay (LOS). Multinomial logistic regression analysis for modelling the data was also performed. Quantitative parameters extracted from gait analysis, electromyography and computed tomography images were used to compare the approaches, but the analysis did not show statistical significance. The variables regarding costs were studied with the Mann-Whitney and Kruskal-Wallis tests. No statistically significant difference between cemented and uncemented prosthesis for the total cost of LOS was found, but the cost of the surgeon had an influence on the overall expenses, affecting the cemented prosthetic approach. The material costs of surgery for the uncemented prosthesis and the cost of theatre of surgery for the cemented prosthesis were the most influential. Multinomial logistic regression identified the Vastus Lateralis variable as statistically significant. The overall accuracy of the model is 93.0%. The use of SS and DMAIC cycle as tools of HTA proved that the cemented and uncemented approaches for THA have similar costs and LOSy.


2017 ◽  
Vol 33 (S1) ◽  
pp. 112-112
Author(s):  
Francesco Faggiano ◽  
Martina Andellini ◽  
Francesca Sabusco ◽  
Liliana De Vivo ◽  
Pietro Derrico ◽  
...  

INTRODUCTION:Pediatric parenteral nutrition is mainly used in neonatal intensive care units (NICU) and requires close collaboration with the hospital pharmacy, especially for manufacturing time, application, preparation and delivery (1). In this context, a Health Technology Assessment (HTA) to evaluate an automatic system compared with a manual system was carried out.METHODS:The Decision-oriented HTA (DoHTA) method (2), coordinated by Bambino Gesù Children's Hospital (BGCH) HTA Unit, was applied to carefully assess the technology. It was developed starting from the European Network for HTA (EUnetHTA) Core Model® and integrated with the Analytic Hierarchy Process (AHP). Its purpose is to identify all the relevant assessment aspects of automatic system integrating the evidence from the scientific literature with experts’ judgments and the specific context analysis for BGCH: an evaluation scheme inherent safety, clinical effectiveness, technical and organizational aspects (represented by a decision tree at three levels: dimensions of evaluation, I and II level indicators) was subsequently created. A weight was finally associated to each identified element and the alternatives’ ranking was defined.RESULTS:The study results show a “performance value” associated with the automatic system greater than about thirty-two percentage points compared to the manual system.CONCLUSIONS:At the current state of the scientific evidence and the results of analysis carried out by the working group, it is believed that the choice should be made to introduce the automatic system is available in BGCH.More specifically, from the point of view of safety, automatic system is safer for both patient and operators; about clinical effectiveness, the system improves the nutritional intake, allows a reduction of post-infusional adverse events and the use of antibiotic therapy; concerning economic aspects, the analysis of available data shows a substantial equivalence between the alternatives considered; the technical-functional aspects show an improvement according to almost all indicators; organizational aspects show a slight improvement in the working and in process management and finally the legal aspects indicate a slight advantage for the automatic system.


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