Abstract
Objective
The study aimed to reach a consensus on the most relevant patient-reported outcomes (PROs), the corresponding measures (PROMs), and measurement frequency during severe asthma patient follow-up.
Methods
Two Delphi rounds were conducted. The questionnaire was developed based on a systematic literature review, a focus group with patients, and a nominal group with experts. It assessed PROs’ relevance and the appropriateness (A) and feasibility (F) of PROMs using a Likert scale (1=totally agree; 9=totally disagree). The consensus was established when ≥75% of participants agreed (1-3) or disagreed (7-9).
Results
Sixty-three professionals (25 hospital pharmacists, 14 allergists, 13 pulmonologists, and 11 nurses) and 5 patients answered the Delphi questionnaire. A consensus was reached on all PROs regarding their relevance. Experts agreed on the use of ACT (A:95.24%; F:95.24%), mini AQLQ (A:93.65; F:79.37%), mMRC dyspnea scale (A:85.71%; F:85.71%), TAI (A:92.06%; F:85.71%), MMAS (A:75.40%; F:82%), and the dispensing register (A:96.83%; F:92.06%). Also considered suitable were: SNOT-22 (A:90.48%; F:73.80%), PSQI (A:82.54; F:63.90%), HADS (A:82.54; F:64%), WPAI (A:77.78%; F:49.20%), TSQM-9 (A:79.37; F:70.50%) and knowledge of asthma questionnaire (A:77%; F:68.80%); however, their use in clinical practice was considered unfeasible. Panelists also agreed on the appropriateness of EQ-5D, which was finally included despite being considered unfeasible (A: 84.13%; F:67.20%) in clinical practice. Agreement was reached on using ACT, TAI, mMRC, and a dispensing register every three months; mini-AQLQ and MMAS every six months; and EQ-5D every twelve months.
Conclusion
This consensus paves the way toward patient-centered care, promoting the development of strategies supporting routine assessment of PROs in severe asthma management.
Acknowledgments
The authors would like to thank the Spanish patient advocacy group FENAER (Federación Española de Asociaciones de Pacientes Alérgicos y con Enfermedades Respiratorias) and the following Spanish Scientific Societies for endorsing the project: Sociedad Española de Neumología y Cirugía Torácica (SEPAR), Sociedad Española de Alergología e Inmunología Clínica (SEAIC), and Sociedad Española de Farmacia Hospitalaria (SEFH) (declaración de interés científico sanitario). The authors would also like to thank all participants in the Delphi consultation, both patients and healthcare professionals from hospital pharmacy (Montserrat Alonso, Milagros Álvarez, María Blanco, Germán Blanco, Mònica Climente, Inés Fernández, Araceli Fernández, Jenifer González, Mónica Granero, Victoria Lerma, Larraitz Leunda, Pilar Ana López, Belén López, Hilario Martínez, Ma Teresa Martínez, Jose Javier Martínez, Herminia Navarro, Inmaculada Plasencia, Jesus Prada, Isabel Puertolas, Esther Ramírez, Julia Sánchez, Isabel Sánchez, Elena Villamañán, Ma Dolores Zamora), allergology (Mónica Antón, David González de Olano, Darío Antolín, Luis Ángel Navarro, Javier Domínguez, Marta Viñas, Antonio Valero, Regina Paulaskas, Irán Sánchez, Soledad Jiménez, Ernesto Enrique, José Vicente Castelló, Joan Bartra, Almudena Testera), pulmonology (Alfredo de Diego, Alicia Padilla, Carolina Cisneros, Marina Blanco, Andrea Trisan, Rocío Díaz, Cleofé Fernández, Elena Curto, Julia García de Pedro, Carlos Almonacid, Mónica Vidal, Guillermo Bentabol, Sandra Vañes), and nursery (Elisa Lillo, Sonia Giraldós, Milagros Figueroa, Marisa Escobar, Pilar de la Calle, Pilar García, Ma Teresa Rodríguez, Ma José Pla, Ma Auxiliadora Guerrero, Ma del Carmen Hernández, Ma Carmen Sánchez). Finally, the authors would like to thank Laura Benedito-Palos, who works for an independent scientific and strategic consultancy (Outcomes’10, S.L.U.), for her contribution to developing and coordinating the project and writing this manuscript. Carla Prego was the person in charge of overseeing the study from GSK.
Disclosure statement
The authors have no conflict with the funding source. IAE declares relationships with GSK, AstraZeneca, and Sanofi. Among the participants in the nominal groups, ECV reports personal fees or non-financial support from AstraZeneca, GSK, Novartis, Sanofi, Chiesi, Boehringer Ingelheim, and Linde; IEG reports consulting fees from Sanofi, AstraZeneca, GSK, Novartis, Chiesi, Leti Pharma, Allergy Therapeutics and Viatrix and payment of honoraria from AstraZeneca, GSK, Novartis, Chiesi, Leti Pharma, and Diater; AHM reports personal fees or non-financial support from AstraZeneca, GSK, Novartis, Sanofi, Chiesi, ALK-Abelló, and Bioproject, outside the submitted work. The other authors declare no conflicts of interest.