Author(s)
Ballini L1, Bonvicini L2, Bottazzi P2, Eisenmann A3, Formoso G2, Giorgi Rossi P2, Rosian-Schikuta I3, Venturelli F2, Vicentini M2, De Laet C4, Ibargoyen N5, Gutierrez Ibarluzea I5, Gimenez E6, García-Pérez L7
1Azienda USL - IRCCS Reggio Emilia; Agenzia Sanitaria e Sociale Regionale-Emilia Romagna, Bologna, Italy, 2Azienda USL - IRCCS Reggio Emilia;, Reggio Emilia, Italy, 3Gesundheit Österreich GmbH (GÖG), Austria, Wien,, Austria, 4Belgian Health Care Knowledge Centre – KCE, Belgium, Brussels, Belgium, 5Basque Office for Health Technology Assessment - Osteba, Bilbao, Spain, 6Agency for Health Quality and Assessment of Catalonia – AquAS,, Barcelona, Spain, 7Health Service of Canary Islands – SESCS, Fundación Canaria de Investigación Sanitaria –FUNCANIS,, El Rosario, Spain
OBJECTIVES: To improve transparency of the process and outputs of the Scoping phase developed within an EUnetHTA’s collaborative Relative Effectiveness Assessment (REA) on FLACS, by adopting and using the GRADEpro tool.
METHODS: At onset of the pivotal phase of Scoping (definition of comparative assessment questions and related PICO), the REA team agreed to pilot the use of GRADEpro: an electronic tool for the application of the GRADE approach for production of clinical evidence summaries and graded recommendations, intended for use by systematic review/health technology assessment (HTA) authors and guideline panelists. During a preliminary e-meeting the REA’s panel (authors, co-authors, and dedicated reviewers from 6 HTA agencies of four European countries plus two external clinical experts) defined the research question, discussed a preliminary list of outcomes, agreed to use the tool to:
- Select relevant effectiveness and safety outcomes.
- Grade the importance of each outcome using scores from 1 to 10 (critical:7-9; important:4-6; not important: 1-3)
Following electronic vote and collection of ratings, median scores were calculated.
RESULTS: The members of the REA panel performed each phase of the process and provided comments on tool’s feasibility and user-friendliness. Five effectiveness outcomes, 16 safety outcomes and three “other outcomes” were selected. Eighteen outcomes were rated as “critical” while 3 safety and 3 other outcomes were rated as “important”. No “not important” outcomes were identified and no outcomes were excluded from the initially agreed list. Results on range of votes and levels of agreement will be presented, together with GRADE Summary of Finding Tables.
CONCLUSIONS: Use of GRADEpro conferred transparency to the selection of clinically relevant and patient important outcomes. This proved particularly valuable for the assessment of FLACs vs standard surgery, as most retrieved clinical studies reported on outcomes discarded by the panel as not relevant. The approach further facilitated interpretation and presentation of findings of REA.
Conference/Value in Health Info
2018-11, ISPOR Europe 2018, Barcelona, Spain
Value in Health, Vol. 21, S3 (October 2018)
Code
PHP306
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Multiple Diseases, Sensory System Disorders
