Bringing GRADEpro to Health Technology Assessment: a pilot study to improve quality and transparency of Scoping and Project Plan in EUnetHTA

Ballini L1, Bonvicini L2, DeLaet C3, Eisenmann A4, Formoso G2, Garcia-Pérez L5, Giménez E6, Giorgi Rossi P2, Gutierrez Ibarluzea I7, Ibargoyen Roteta N7, Rosian I8, Venturelli F9, Vicentini M2
1Agenzia Sanitaria Sociale Regionale-Emilia Romagna (ASSR); Local Health Authority (AUSL-IRCCS) Reggio Emilia, 2Local Health Authority (AUSL-IRCCS) Reggio Emilia, 3Belgian Health Care Knowledge Centre- KCE, 4Gesundheit Österreich GmbH- GÖG, 5Servicio de Evaluación del Servicio Canario de la Salud (SESCS), 6Agency for Health Quality and Assessment of Catalonia- AQuAS, 7Osteba (Basque Office for HTA), 8Gesundheit Österreich GmbH - GÖG, 9Local Health Authority (AUSL-IRCCS) Reggio Emilia; Clinical and Experimental Medicine PhD Program, University of Modena and Reggio Emilia

Background: Within the European Network for Health Technology Assessment (EUnetHTA), Joint/Collaborative assessments of health technologies foresee the participation of the assessment team (authors, co-authors, reviewers) and external experts (clinicians, patients) to a well-structured scoping phase to define research questions and PICOs for the report. To date, agreement on questions and outcomes has been managed through scoping emeetings/workshop, while level of importance for each outcome is seldom stated in the project plan.

Objectives: To pilot use of GRADEpro during scoping for a Collaborative Assessment to obtain a tracked, transparent process of research questions’ development and an a priori rating of outcomes’ importance.

Methods: We convened a team to assess comparative effectiveness and safety of femtosecond laser assisted surgery vs standard surgery. The team comprised six HTA agencies from four European countries and two external experts. At the scoping emeeting all members agreed to pilot GRADEpro, and discussed assessment questions and preliminary list of outcomes. All steps of GRADEpro were followed: definition of question(s), list of outcomes, rating of outcomes using the dedicated platform.

Results: Every step of the process was completed by all participants and we collected comments on feasibility. Through the GRADEpro platform members had opportunities (beside the emeeting) to add comments and suggestions throughout the scoping phase; rating of importance of outcomes from individual members led to an agreed list of outcomes and ratings. The Collaborative Assessment of the project plan was completed and published within the deadline.

Conclusions: Use of GRADEpro proved a valuable and feasible option for carrying out the scoping phase within EUnetHTA’s assessment. The tool offered additional means of communication and information sharing between participants in different geographical locations. The transparent process facilitated the interpretation of evidence, making the assessment framework more robust.

Patient or healthcare consumer involvement: Despite several attempts, involvement of patients from European and national organization was not attained. The use of GRADEpro was mentioned among the deterrents to participation, as too technical and impersonal. More effective means of involvement are needed.