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PP502 AQuAS Learnings From Implementing GRADE Approach, Especially The Evidence To Decision Framework And Multidisciplinary Final Consensus
- Emmanuel Giménez, Maria-Dolors Estrada, Xavier Garcia, Maria Auxiliadora Castillo, Leonor Varela, Mireia Espallargues
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- International Journal of Technology Assessment in Health Care / Volume 36 / Issue S1 / December 2020
- Published online by Cambridge University Press:
- 28 December 2020, p. 40
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Introduction
In recent years, the GRADE system has been adopted internationally to make judgments about evidence and/or recommendations. Recently, the Spanish Network of HTA (RedETS) has promoted among its members the use of the GRADE system, especially the “Evidence to Decision” tool (EtD) where a multidisciplinary panel is involved. The objective is to describe the methodological approach with the first AQuAS experience using this methodology in HTA, focused on inclusion/exclusion of these technologies in the Spanish National Health Service (NHS) portfolio.
MethodsThe standard EtD tool was used for clinical and financial decisions. Four multidisciplinary panels were constituted by relevant professionals in clinical practice and, where possible, patients. The four panels discussed on the following four interventions: in two cases, AQuAS prepared preliminary recommendations and participants provided feedback, while in the other two cases, experts received the evidence review and were asked to formulate recommendations. These recommendations were voted on and, in the case of disagreement, adapted and then voted on for a second time. Finally, any discrepancies were noted in the report. Evaluated interventions were: maxillofacial 3D-reconstruction, cataract surgery equipment, non-invasive surgery in obesity and pharmacological treatment in secondary fracture prevention.
ResultsEspecially when more than one evaluative question was addressed in the HTA report the EtD and the consensus results required discussion. Consensus was fast but not immediate. Meeting length depended on the number of HTA questions and the amount of original disagreement in the recommendations. The nuances on how to write recommendations also affected the panel duration. All panels were successful in formulating the final recommendations.
ConclusionsStandardizing methodologies increased the homogeneity across HTA reports. The GRADE system is a feasible and useful tool because it favors transparency and rigor in drawing up recommendations on the inclusion/exclusion of technologies in the NHS portfolio. The EtD framework complements GRADE tables, which display the relevant evidence in a way that can be used by multidisciplinary groups to reach a consensual recommendation.
Although all participants received a short training video, more experience in the use of these methodologies might shorten the duration of the process and facilitate reaching consensus. Some considerations on how to overcome the difficulties and complexity of this methodological approach are discussed.
PP20 Challenges In The Health Technology Assessment Of New/Emergent Non-Pharmacological Technologies
- Emmanuel Gimenez Garcia, Xavier Garcia, Rita Reig-Viader, Arantxa Romero-Tamarit, Iñaki Gutiérrez-Ibarluzea, Mireia Espallargues
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- International Journal of Technology Assessment in Health Care / Volume 35 / Issue S1 / 2019
- Published online by Cambridge University Press:
- 31 December 2019, p. 40
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Introduction
The methodological guides for the assessment of new/emerging non-pharmacological technologies differ from the traditional health technology assessment (HTA) guidelines developed by the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS). The aim of this study is to identify the special features and challenges of carrying out HTA on new/emergent non-pharmacological technologies.
MethodsThe application of traditional and new/emergent HTA guidelines is compared along the consecutive evaluation phases in four practical cases carried out at the Agency for Health Quality and Assessment of Catalonia (AQuAS) in 2017-2018.
ResultsMain learning and outstanding challenges: (i) Instead of following a defined protocol, the evaluations are carried out from a preliminary short report which generates a lack of justification and delimitation of its scope. (ii) References’ identification and data extraction are often limited due to lack of studies, and sometimes require the use of grey literature or other sources less informative, for example, trial registries. It can be challenging to exclude references related to other indications. (iii) The assessment of resource use and costs of running the technology is complicated due to the lack of public prices information and specific impacts of use. (iv) The evidence considered during the assessment usually does not meet high quality requirements (risk of bias) because of indirect evidence, lack of comparator or no having clearly defined outcomes, among others. (v) It's difficult to draw conclusions and, consequently, recommendations due to abovementioned aspects and especially for the usual evidence gap that faces this type of technology in early stages of diffusion and/or in a competition situation of manufacturer companies.
ConclusionsThe most recent innovation in non-pharmacological technologies merits a differentiated assessment approach. However, there is need to reconsider the methodology applied in order to overcome the challenges and limitations identified.
OP28 Patient Involvement at AQuAS: Experiences And Reflections For Future
- Lina Masana, Emmanuel Gimenez Garcia, Mireia Espallargues
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- International Journal of Technology Assessment in Health Care / Volume 35 / Issue S1 / 2019
- Published online by Cambridge University Press:
- 31 December 2019, p. 6
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Introduction
AQuAS is gradually incorporating patient involvement in health technology assessment (HTA). We present two experiences conducted during 2018 and the different methods and approaches used. The aim is to reflect on learnings from those experiences to improve ways for increasing patient involvement with HTA at AQuAS.
MethodsWe conducted two experiences using different quantitative and qualitative techniques (mix-methods approach). The first, a focus group discussion regarding the use of 3D-technologies for maxillofacial reconstruction with a selection of hospital patients that received maxillofacial reconstruction, which included the use of a quality-of-life retrospective self-assessment tool. The second, a sequence of email correspondence regarding cataract surgery technology (femtosecond laser-assisted cataract surgery (FLACS), in the context of an EUnetHTA Joint Assessment) with a patients’ association representative, to learn their opinion regarding the use of laser technology.
ResultsMain learnings were: (1) patients and associations have different levels of knowledge and expertise to consider when planning an HTA; (2) sharing experience and knowledge among peers (i.e. focus group) proved to have a positive impact on patients and worked as a resource for some to improve knowledge on their condition; (3) critiques were received regarding a specific Patient Reported Experience template for HTA patient involvement (iv) quality of life retrospective self-assessment tool provided unexpected positive and negative results.
ConclusionsRecent patient involvement in HTA at AQuAS proved to be useful to complement HTA reports. We believe that patients’ experiences and opinions can help decision-making regarding the use, disinvestment or incorporation of health technologies, contribute to the improvement of tools and survey accuracy and improve doctor-patient communication. Their involvement might be beneficial for them to gain more knowledge, share experiences, reflect on their health situation and improve communication with the professionals that treat them. Future patient-involvement in HTA is needed, e.g. considering the social perspective in economic evaluations or including patients in recommendation consensus panels.
PP14 Development Of The European Network For Health Technology Assessment Standards Tool For Registries In Health Technology Assessment
- Emmanuel Gimenez Garcia, Mireia Espallargues, Jae Long, Maja Valentic, Irena Guzina, Jorge Rodrigues, Leonor Varela-Lema, Toni Dedeu
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- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, p. 70
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Introduction:
Bridging gaps between registry-holders, Health Technology Assessment (HTA) producers and users is one of the aims of the European Network for HTA (EUnetHTA) Joint Action 3. In this context, a post-launch evidence generation tool is being developed, including a quality standards tool for registries in HTA. The standards tool for registries in HTA will enable, among others, registry owners to consistently collect high quality registry data, and HTA agencies to use proper registry data collected by others as evidence for their assessments. The objective is to present the first draft version of the tool structure, which is going to be piloted during the forthcoming months.
Methods:A review and description of the currently available first version (November 2017) sections, items and criteria for HTA studies.
Results:The tool is divided in three sections; “Methodological Information”, “Essential Standards” and “Additional Requirements”. The first section enables users to analyze not only the ability of the registry to answer to research questions but also to check the registry transparency. The second section encloses the essential elements of good practice and evidence quality (therefore all of them must be met before an HTA report can use the registry data). Finally, the third section includes elements of good practice and evidence quality useful to consider in planning and evaluating registries for specific purposes. Although suggestions are defined, the third section item requirements could depend on the individual HTA agency perspectives and needs.
Conclusions:There is a clear growing availability and requirement for real world data for health technology assessment. A piloted and robust registry standards tool for HTA can provide a relevant basis to improve both the evidence generation but also to make more trustful and excellent evaluations.
PP166 RedETS: 10 Years Of Economic HTA (Medical Devices) In Spain, 2006–2016
- Emmanuel Gimenez Garcia, Mireia Espallargues, Toni Dedeu
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- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, pp. 131-132
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Introduction:
RedETS, created in 2006, is the Spanish network of health technology assessment agencies. The objective of this work is to describe and assess the quality of the full economic evaluation reports on medical devices (FEEMD) carried out by RedETS.
Methods:The FEEMD were identified through the RedETS website publications database. Assessments about screening technologies were not included. The characteristics of FEEMD were analyzed using a formal RedETS HTA quality checklist. The characteristics extracted were analyzed through a descriptive univariate analysis.
Results : Twenty-six FEEMD were found. The publication years were distributed quite uniformly over time (approximately 2/year), although 7 were published in 2008 and 7 in 2013. Thirteen studies analyzed cost-utility, ten cost-effectiveness but not utility, and three both. The most frequent medical devices (MD) class analyzed were “In vitro diagnosis MD” (n = 8) and Class III products (8). The most frequent sources to analyze effectiveness were literature (22) and data collected through ad hoc studies (6). The main sources of unit costs were official public tariffs (14), manufacturers direct values (10) analytical accounting of one/more centers or regions (11) and DRGs (7). In relation to the modelling used, 14 evaluations performed Markov models and 7 decision trees. The perspective of 23 studies was that of the National Health System (NHS), and the rest corresponded to the perspective of a specific region (2) or social perspective (1). All studies analyzing time horizons greater than 1.5 years, except for 1, applied discount rates in the modelling. All studies included a sensitivity analysis.
Conclusions:The economic evaluations of MD published by the RedETS accomplish most of the quality checklist aspects and are therefore exhaustive. These FEEMD have been used in the framework of decision making for an efficient management of the NHS basic portfolio.
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- By Rose Teteki Abbey, K. C. Abraham, David Tuesday Adamo, LeRoy H. Aden, Efrain Agosto, Victor Aguilan, Gillian T. W. Ahlgren, Charanjit Kaur AjitSingh, Dorothy B E A Akoto, Giuseppe Alberigo, Daniel E. Albrecht, Ruth Albrecht, Daniel O. Aleshire, Urs Altermatt, Anand Amaladass, Michael Amaladoss, James N. Amanze, Lesley G. Anderson, Thomas C. Anderson, Victor Anderson, Hope S. Antone, María Pilar Aquino, Paula Arai, Victorio Araya Guillén, S. Wesley Ariarajah, Ellen T. Armour, Brett Gregory Armstrong, Atsuhiro Asano, Naim Stifan Ateek, Mahmoud Ayoub, John Alembillah Azumah, Mercedes L. García Bachmann, Irena Backus, J. Wayne Baker, Mieke Bal, Lewis V. Baldwin, William Barbieri, António Barbosa da Silva, David Basinger, Bolaji Olukemi Bateye, Oswald Bayer, Daniel H. Bays, Rosalie Beck, Nancy Elizabeth Bedford, Guy-Thomas Bedouelle, Chorbishop Seely Beggiani, Wolfgang Behringer, Christopher M. Bellitto, Byard Bennett, Harold V. Bennett, Teresa Berger, Miguel A. Bernad, Henley Bernard, Alan E. Bernstein, Jon L. Berquist, Johannes Beutler, Ana María Bidegain, Matthew P. Binkewicz, Jennifer Bird, Joseph Blenkinsopp, Dmytro Bondarenko, Paulo Bonfatti, Riet en Pim Bons-Storm, Jessica A. Boon, Marcus J. Borg, Mark Bosco, Peter C. Bouteneff, François Bovon, William D. Bowman, Paul S. Boyer, David Brakke, Richard E. Brantley, Marcus Braybrooke, Ian Breward, Ênio José da Costa Brito, Jewel Spears Brooker, Johannes Brosseder, Nicholas Canfield Read Brown, Robert F. Brown, Pamela K. Brubaker, Walter Brueggemann, Bishop Colin O. Buchanan, Stanley M. Burgess, Amy Nelson Burnett, J. Patout Burns, David B. Burrell, David Buttrick, James P. Byrd, Lavinia Byrne, Gerado Caetano, Marcos Caldas, Alkiviadis Calivas, William J. Callahan, Salvatore Calomino, Euan K. Cameron, William S. Campbell, Marcelo Ayres Camurça, Daniel F. Caner, Paul E. Capetz, Carlos F. Cardoza-Orlandi, Patrick W. Carey, Barbara Carvill, Hal Cauthron, Subhadra Mitra Channa, Mark D. Chapman, James H. Charlesworth, Kenneth R. Chase, Chen Zemin, Luciano Chianeque, Philip Chia Phin Yin, Francisca H. Chimhanda, Daniel Chiquete, John T. Chirban, Soobin Choi, Robert Choquette, Mita Choudhury, Gerald Christianson, John Chryssavgis, Sejong Chun, Esther Chung-Kim, Charles M. A. Clark, Elizabeth A. Clark, Sathianathan Clarke, Fred Cloud, John B. Cobb, W. Owen Cole, John A Coleman, John J. Collins, Sylvia Collins-Mayo, Paul K. Conkin, Beth A. Conklin, Sean Connolly, Demetrios J. Constantelos, Michael A. Conway, Paula M. Cooey, Austin Cooper, Michael L. Cooper-White, Pamela Cooper-White, L. William Countryman, Sérgio Coutinho, Pamela Couture, Shannon Craigo-Snell, James L. Crenshaw, David Crowner, Humberto Horacio Cucchetti, Lawrence S. Cunningham, Elizabeth Mason Currier, Emmanuel Cutrone, Mary L. Daniel, David D. Daniels, Robert Darden, Rolf Darge, Isaiah Dau, Jeffry C. Davis, Jane Dawson, Valentin Dedji, John W. de Gruchy, Paul DeHart, Wendy J. Deichmann Edwards, Miguel A. De La Torre, George E. Demacopoulos, Thomas de Mayo, Leah DeVun, Beatriz de Vasconcellos Dias, Dennis C. Dickerson, John M. Dillon, Luis Miguel Donatello, Igor Dorfmann-Lazarev, Susanna Drake, Jonathan A. Draper, N. Dreher Martin, Otto Dreydoppel, Angelyn Dries, A. J. Droge, Francis X. D'Sa, Marilyn Dunn, Nicole Wilkinson Duran, Rifaat Ebied, Mark J. Edwards, William H. Edwards, Leonard H. Ehrlich, Nancy L. Eiesland, Martin Elbel, J. Harold Ellens, Stephen Ellingson, Marvin M. Ellison, Robert Ellsberg, Jean Bethke Elshtain, Eldon Jay Epp, Peter C. Erb, Tassilo Erhardt, Maria Erling, Noel Leo Erskine, Gillian R. Evans, Virginia Fabella, Michael A. Fahey, Edward Farley, Margaret A. Farley, Wendy Farley, Robert Fastiggi, Seena Fazel, Duncan S. Ferguson, Helwar Figueroa, Paul Corby Finney, Kyriaki Karidoyanes FitzGerald, Thomas E. FitzGerald, John R. Fitzmier, Marie Therese Flanagan, Sabina Flanagan, Claude Flipo, Ronald B. Flowers, Carole Fontaine, David Ford, Mary Ford, Stephanie A. Ford, Jim Forest, William Franke, Robert M. Franklin, Ruth Franzén, Edward H. Friedman, Samuel Frouisou, Lorelei F. Fuchs, Jojo M. Fung, Inger Furseth, Richard R. Gaillardetz, Brandon Gallaher, China Galland, Mark Galli, Ismael García, Tharscisse Gatwa, Jean-Marie Gaudeul, Luis María Gavilanes del Castillo, Pavel L. Gavrilyuk, Volney P. Gay, Metropolitan Athanasios Geevargis, Kondothra M. George, Mary Gerhart, Simon Gikandi, Maurice Gilbert, Michael J. Gillgannon, Verónica Giménez Beliveau, Terryl Givens, Beth Glazier-McDonald, Philip Gleason, Menghun Goh, Brian Golding, Bishop Hilario M. Gomez, Michelle A. Gonzalez, Donald K. Gorrell, Roy Gottfried, Tamara Grdzelidze, Joel B. Green, Niels Henrik Gregersen, Cristina Grenholm, Herbert Griffiths, Eric W. Gritsch, Erich S. Gruen, Christoffer H. Grundmann, Paul H. Gundani, Jon P. Gunnemann, Petre Guran, Vidar L. Haanes, Jeremiah M. 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Lotz, Andrew Louth, Robin W. Lovin, William Luis, Frank D. Macchia, Diarmaid N. J. MacCulloch, Kirk R. MacGregor, Marjory A. MacLean, Donald MacLeod, Tomas S. Maddela, Inge Mager, Laurenti Magesa, David G. Maillu, Fortunato Mallimaci, Philip Mamalakis, Kä Mana, Ukachukwu Chris Manus, Herbert Robinson Marbury, Reuel Norman Marigza, Jacqueline Mariña, Antti Marjanen, Luiz C. L. Marques, Madipoane Masenya (ngwan'a Mphahlele), Caleb J. D. Maskell, Steve Mason, Thomas Massaro, Fernando Matamoros Ponce, András Máté-Tóth, Odair Pedroso Mateus, Dinis Matsolo, Fumitaka Matsuoka, John D'Arcy May, Yelena Mazour-Matusevich, Theodore Mbazumutima, John S. McClure, Christian McConnell, Lee Martin McDonald, Gary B. McGee, Thomas McGowan, Alister E. McGrath, Richard J. McGregor, John A. McGuckin, Maud Burnett McInerney, Elsie Anne McKee, Mary B. McKinley, James F. McMillan, Ernan McMullin, Kathleen E. McVey, M. 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Yee, Viktor Yelensky, Yeo Khiok-Khng, Gustav K. K. Yeung, Angela Yiu, Amos Yong, Yong Ting Jin, You Bin, Youhanna Nessim Youssef, Eliana Yunes, Robert Michael Zaller, Valarie H. Ziegler, Barbara Brown Zikmund, Joyce Ann Zimmerman, Aurora Zlotnik, Zhuo Xinping
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