VP148 Health Technology Assessment Of Femtosecond Laser: A New Frontier In Cataract Surgery

2017 ◽  
Vol 33 (S1) ◽  
pp. 217-218
Author(s):  
Francesco Faggiano ◽  
Martina Andellini ◽  
Francesca Sabusco ◽  
Pietro Derrico ◽  
Matteo Ritrovato

INTRODUCTION:Cataract surgery is one of the most frequent ophthalmological surgical procedures performed in children. However, clinical outcomes in younger patients are generally unpredictable. Currently, cataract surgery can be performed through the traditional phacoemulsification ultrasound probe or Femtosecond Laser (1). The aim of this study is to describe the application of Decision-oriented Health Technology Assessment (HTA) (DoHTA) to assess the femtosecond laser-assisted cataract surgery (FLACS) compared to conventional cataract surgery (CCS).METHODS:To evaluate safety, costs, organizational aspects, effectiveness and technical characteristics of FLACS compared with CCS, a DoHTA method was applied (2). DoHTA is a new implementation of the European Network For HTA (EUnetHTA) Core Model®, which integrates the Multi-Criteria Decision Analysis (MCDA) using the Analytic Hierarchy Process (AHP). All the relevant assessment aspects of FLACS are summarized in a hierarchical decision tree by means of Key Performance Indicators (KPI), subsequently weighted through pairwise comparisons. Lastly, FLACS and CCS were ranked against lowest indicators of decision tree.RESULTS:The multidisciplinary assessment took into consideration all the aspects and recommendations about the benefits and disadvantages of FLACS compared to CCS. DoHTA results showed that FLACS surgery is safe and effective for pediatric patients. Furthermore, FLACS seems to overcome CCS with several important developments such as increased precision of anterior capsulotomy, reduced ultrasound power requirement during phacoemulsification, decreased collateral tissue damage, increased accuracy and consistency in surgical results as well as better visual outcomes. Notwithstanding such clinical improvements, FLACS is more expensive than its comparator.CONCLUSIONS:The DoHTA results integrated the evidence from the scientific literature (which is still limited) with experts judgments. Indeed, although FLACS had the highest purchase price, DoHTA results showed that FL improves the quality of cataract surgery. Based on our results and taking into consideration the positive safety and clinical effectiveness features, we conclude that FLACS may be a good alternative to CCS.

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.


2019 ◽  
Vol 35 (S1) ◽  
pp. 70-71
Author(s):  
Roxana Di Mauro ◽  
Francesco Faggiano ◽  
Martina Andellini ◽  
Pietro Derrico ◽  
Matteo Ritrovato

IntroductionA health technology assessment (HTA) process to evaluate the best intensive care ventilator manufacturers has been carried out in different pediatric intensive care units (ICUs) of Bambino Gesù Children's Hospital (OPBG). The purpose of this study is to determine: (i) the most relevant features of a ventilator to be considered between different manufacturers, and (ii) the methodology to conduct the assessment to support the decision-making process about the choice to adopt the suitable technology for OPBG.MethodsThe decision-oriented HTA method (Do-HTA), developed by the HTA unit of OPBG, was applied to conduct the assessment. Do-HTA involves the integration of the European Network for HTA (EUnetHTA) CoreModel and the Analytic Hierarchy Process with the support of an informatics tool. It provides the definition and numerical evaluation of assessment parameters to evaluate the performance of technologies. A literature review involving ICU professionals was used to define and weight the assessment elements on clinical, technical, organizational, economic, and safety domains. In particular, a subgroup of these domains has been included in a checklist for the comparative evaluation of different ventilator models, each of which was tested in three independent runs performed in three different ICUs.ResultsResults show that safety and clinical effectiveness had highest the impact within the evaluation, followed by organizational, technical and economic aspects. A percentage value per each ventilator has been assigned, representing the global performances regarding the assessment elements.ConclusionsThis study presents and discusses the benefits and drawbacks of innovative features of ventilators, all characteristics to be taken into account during the evaluation process and a methodology to conduct it. The project identified the best performing ventilator model through a collective decision, giving a reliable recommendation to the Hospital Decision Makers.


2019 ◽  
Vol 35 (S1) ◽  
pp. 70-70
Author(s):  
Roxana Di Mauro ◽  
Francesco Faggiano ◽  
Martina Andellini ◽  
Pietro Derrico ◽  
Matteo Ritrovato

IntroductionRecent studies have investigated the re-organization and automation of laboratory medicine as a challenge for the hospital in terms of reduction of costs, turnaround time, workload, optimization of human and technological resources and improvement of safety. The purpose of this study was to conduct a health technology assessment (HTA) evaluation process about the possibility to re-organize and automate laboratory medicine at Bambino Gesù Children's Hospital.MethodsThe decision-oriented HTA (Do-HTA) method, involving the integration of the European Network for HTA (EUnetHTA) CoreModel and the Analytic Hierarchy Process, was applied to assess the best technology solution. Twenty-one professionals were involved to define tender specifications related to the adaptation works of the new dedicated rooms, and the automatic technologies and organizational solutions for the new laboratory department. Finally, two manufacturer companies were consulted.ResultsUsing Do-HTA, the study was focused on laboratory technologies while the infrastructure evaluation was conducted by the Engineering and Logistic Units of the hospital. Results showed that the total performance score of the first proposal was slightly higher (2.5 percent) than the second one, proving the comparable high qualitative level of both manufactures technologies. After an accurate analysis, evaluating all aspects (safety, clinical efficacy, cost, organization & technical criteria) and integrating the infrastructure evaluation, the decision has fallen upon the first company offer.ConclusionsThis HTA project provided an in-depth examination of two proposed technological and organizational solutions. Thanks to the Do-HTA method, which produced and developed data and all needed information, it was possible to guide and assist the decision makers on the choice between the two technical solutions.


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. 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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