Hostname: page-component-586b7cd67f-r5fsc Total loading time: 0 Render date: 2024-11-22T06:26:21.106Z Has data issue: false hasContentIssue false

Development of a decisional flowchart for meaningful patient involvement in Health Technology Assessment

Published online by Cambridge University Press:  03 December 2020

Ana Toledo-Chávarri*
Affiliation:
Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC), El Rosario, S/C Tenerife, Spain Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Galdakao, Spain Servicio de Evaluación y Planificación, Dirección del Servicio Canario de la Salud, Camino Candelaria s/n. C.S. El Chorrillo, 38109, El Rosario, S/C Tenerife, Spain
Marie-Pierre Gagnon
Affiliation:
Faculty of Nursing Sciences, Université Laval, Quebec City, Quebec, Canada
Yolanda Álvarez-Pérez
Affiliation:
Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC), El Rosario, S/C Tenerife, Spain
Lilisbeth Perestelo-Pérez
Affiliation:
Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Galdakao, Spain Servicio de Evaluación y Planificación del Servicio Canario de la Salud (SESCS), Santa Cruz de Tenerife, Spain
Yolanda Triñanes Pego
Affiliation:
Unidad de Asesoramiento Científico-técnico, Avalia-t, Axencia de Coñecemento en Saúde (ACIS), Servizo Galego de Saúde, Santiago de Compostela, La Coruña, Spain
Pedro Serrano Aguilar
Affiliation:
Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Galdakao, Spain Servicio de Evaluación y Planificación del Servicio Canario de la Salud (SESCS), Santa Cruz de Tenerife, Spain
*
Author for correspondence: Ana Toledo-Chávarri, E-mail: [email protected]

Abstract

Introduction

This paper aims to describe the development of a flowchart to guide the decisions of researchers in the Spanish Network for Health Technology Assessment of the National Health System (RedETS) regarding patient involvement (PI) in Health Technology Assessment (HTA). By doing so, it reflects on current methodological challenges in PI in the HTA field: how best to combine PI methods and what is the role of patient-based evidence.

Methods

A decisional flowchart for PI in HTA was developed between March and April 2019 following an iterative process, reviewed by the members of the PI Interest Group and other RedETS members and validated during an online deliberative meeting. The development of the flowchart was based on a previous methodological framework assessed in a pilot study.

Results

The guidelines on how to involve patients in HTA in the RedETS were graphically represented in a flowchart. PI must be included in all HTA reports, except those that assess technologies with no relevant impact on patients’ experiences, values, and preferences. Patient organizations or expert patients related to the topic of the HTA report must be identified and invited. These patients can participate in protocol development, outcomes' identification, assessment process, and report review. When the technology assessed affects in a relevant way patient experiences, values, and preferences, patient-based evidence should be included through a systematic literature review or a primary study.

Conclusions

The decisional flowchart for PI in HTA contributes to the current methodological challenges by proposing a combination of direct involvement and patient-based evidence.

Type
Method
Copyright
Copyright © The Author(s), 2020. Published by Cambridge University Press

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Footnotes

*

From AQuAS: Emmanuel Giménez García, Lina Masana, Elisa Puigdomènech (REDISSEC), Rita Reig Viander. From Osteba: Asun Gutiérrez Iglesias, Nora Ibargoyen Roteta, Marta López-Argumedo, Eva Reviriego. From AETSA: Elena Baños, Soledad Benot, Juan Máximo Linde. From SESCS: Lidia García Pérez, Beatriz León Salas, Renata Linertova, Vanesa Ramos García, Amado Rivero Santana, Alezandra Torres Castaño, Marría del Mar Trujillo-Martin. From avalia-T: Paula Cantero Muñoz. From IACS: Lucía Prieto Remón, María José Vicente Edo. From ISCIII: Matilde Palma Ruiz. From UETS: Blanca Novella Arribas.

References

Serrano-Aguilar, P, Asua-Batarrita, J, Molina-López, M, Espallargues, M, Pons-Rafols, J, García-Armesto, S, et al. The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS). Int J Technol Assess Health Care. 2019;35:176–80.CrossRefGoogle Scholar
Puñal-Riobóo, J, Baños Álvarez, E, Varela Lema, L, Castillo Muñoz, M, Atienza Merino, G, Ubago Pérez, R, et al. Guía para la elaboración y adaptación de informes rápidos de evaluación de tecnologías sanitarias. Agencia Gallega para la gestión del Conocimiento en Salud, Unidad de Asesoramiento Científico-técnico avalia-t, Ministerio de Sanidad SS e I, editors. Santiago de Compostela; Madrid: Red Española de Agencias de Evaluación de Tecnologías y Prestaciones del SNS. Agencia Gallega para la Gestión del Conocimiento en Salud. Unidad de Asesoramiento Científico-Técnico, avalia-t; 2016.Google Scholar
Facey, K, Plough Hansen, H, Single, A. Patient involvement in Health Technology Assessment. Singapore: Springer-Nature; 2017.CrossRefGoogle Scholar
Toledo-Chávarri, A, Perestelo-Pérez, L, Álvarez-Pérez, Y, Abt-Sacks, A, Santoro Domingo, P, Villalón, D, et al. Participación de los pacientes en la Evaluación de Tecnologías Sanitarias: manual metodológico. Servicio de Evaluación del Servicio Canario de la Salud. Ministerio de Sanidad, Servicios Sociales e Igualdad. Servicio de Evaluación del Servicio Canario de la Salud, Informes de Evaluación de Tecnologías Sanitarias; 2016 [cited 2020 Jul 28]; Available from: https://redets.mscbs.gob.es/Google Scholar
Toledo-Chávarri, A, Alvarez-Perez, Y, Triñanes, Y, Perestelo-Pérez, L, Espallargues, M, Palma, M, et al. Toward a strategy to involve patients in Health Technology Assessment in Spain. Int J Technol Assess Health Care. 2019;35:92–8.CrossRefGoogle Scholar
Gagnon, MP, Dipankui, MT, DeJean, D. Evaluation of patient involvement in HTA. In: Facey, K, Ploug Hansen, H, Single, A, editors. Patient involvement in Health Technology Assessment. Singapore: Adis; 2017. p. 201–13.CrossRefGoogle Scholar
Weeks, L, Polisena, J, Scott, AM, Holtorf, AP, Staniszewska, S, Facey, K. Evaluation of patient and public involvement initiatives in Health Technology Assessment: A survey of international agencies. Int J Technol Assess Health Care. 2017;33:715–23.CrossRefGoogle ScholarPubMed
Toledo-Chávarri, A, Triñanes Pego, Y, Reviriego Rodrigo, E, Ibargoyen Roteta, N, Novella-Arribas, B, Vicente Edo, MJ, et al. Evaluation of patient involvement strategies in Health Technology Assessment in Spain: The viewpoint of HTA researchers. Int J Technol Assess Health Care. 2020;16.https://pubmed.ncbi.nlm.nih.gov/32914735/.Google ScholarPubMed
Giménez, E, Reynolds, J, Espallargues, M. Evaluación del impacto económico, organizativo y de la seguridad de la dispensación robotizada de fármacos en hospitales en España. Barcelona: Agència de Qualitat i Avaluació Sanitàries de Catalunya. Departament de Salut. Generalitat de Catalunya. Informes de Evaluación de Tecnologías Sanitarias; 2019 [cited 2020 Jul 28]; Available from: https://redets.mscbs.gob.es/.Google Scholar
Herrera-Ramos, E, Bermúdez-Pérez, C, Ojeda Cruz, AM, Perdomo-Cabrera, VL, González-Rodríguez, JJ, García-Pérez, L, et al. Sistema PACS y su posible aplicación en la gestión de objetos clínicos NO-DICOM. Ministerio de Sanidad, Consumo y Bienestar Social. Servicio de Evaluación del Servicio Canario de la Salud, Informes de Evaluación de Tecnologías Sanitarias.; 2019 [cited 2020 Jul 28]; Available from: https://redets.mscbs.gob.es/.Google Scholar
EUnetHTA Joint Action 2, Work Package 8 [Internet] HTA Core Model ® version 3.0 (Pdf). c2016 [cited 2020 Apr 23]; Available from: http://www.corehta.info/model/HTACoreModel3.0.pdf.Google Scholar
GRADE-CERQual [Internet] GRADE-CERQual confidence in the evidence from reviews of qualitative research. c2018 [cited 2020 Apr 23]; Available from: https://www.cerqual.org/.Google Scholar
Cochrane Qualitative & Implementation Methods Group [Internet] Cochrane qualitative & implementation methods group. c2020 [cited 2020 Apr 23]; Available from: https://methods.cochrane.org/qi/welcome.Google Scholar
Hermosilla-Gago, T, Grupo de Expertos de las Agencias de Evaluación de Tecnologías Sanitarias de España. Manual para adaptar informes de evaluación de tecnologías sanitarias a los ciudadanos (MADETSCI). Sevilla: Agencia de Evaluación de Tecnologías Sanitarias de Andalucía. Consejería de Salud. Junta de Andalucía y Ministerio de Sanidad y Consumo; 2011 [cited 2020 Jul 28]; Available from: https://redets.mscbs.gob.es/.Google Scholar
HTAi Patient and Citizen Involvement Interest Group [Internet] HTAi patient group submission template – Non medicines HTA. Modified Version 1 in Spanish: July 2019. c2019 [cited 2020 May 25]; Available from: https://htai.org/interest-groups/pcig/resources/for-patients-and-patient-groups/.Google Scholar
Hunter, A, Facey, K, Thomas, V, Haerry, D, Warner, K, Klingmann, I, et al. EUPATI guidance for patient involvement in medicines research and development: Health Technology Assessment. Front Med (Lausanne). 2018;5:231.CrossRefGoogle ScholarPubMed
Bagley, HJ, Short, H, Harman, NL, Hickey, HR, Gamble, CL, Woolfall, K, et al. A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials – A work in progress. Res Involv Engagem. 2016;2:15.CrossRefGoogle ScholarPubMed
Wortley, S, Tong, A, Howard, K. Community views and perspectives on public engagement in Health Technology Assessment decision making. Aust Health Rev. 2017;41:6874.CrossRefGoogle ScholarPubMed
Hämeen-Anttila, K, Komulainen, J, Enlund, H, Mäkelä, M, Mäkinen, E, Rannanheimo, P, et al. Incorporating patient perspectives in Health Technology Assessments and clinical practice guidelines. Res Social Adm Pharm. 2016;12:903–13.CrossRefGoogle ScholarPubMed
OHTAC Public Engagement Subcommittee [Internet] Public Engagement for Health Technology Assessment at Health Quality Ontario–Final Report From the Ontario Health Technology Advisory Committee Public Engagement Subcommittee. Toronto: Queen's Printer for Ontario; cited 2015 April. 57 p.; Available from: https://www.hqontario.ca/Portals/0/documents/evidence/special-reports/report-subcommittee-20150407-en.pdf.Google Scholar
Kristensen, F, Sigmund, H. Health Technology Assessment handbook. 2nd ed. Copenhagen: Danish Centre for Health Technology Assessment, National Board of Health; 2008.Google Scholar
Rozmovits, L, Mai, H, Chambers, A, Chan, K. What does meaningful look like? A qualitative study of patient engagement at the Pan-Canadian Oncology Drug Review: Perspectives of reviewers and payers. J Health Serv Res Policy. 2018;23:72–9.CrossRefGoogle Scholar
Gauvin, FP, Abelson, J, Giacomini, M, Eyles, J, Lavis, JN. Moving cautiously: Public involvement and the Health Technology Assessment community. Int J Technol Assess Health Care. 2011;27:43–9.CrossRefGoogle ScholarPubMed
Staniszewska, S, Werkö, S. Patient-based evidence in HTA. In: Facey, K, Plough Hansen, H, Single, A, editors. Patient involvement in Health Technology Assessment. Singapore: Springer-Nature; 2017.Google Scholar