Luis Pérez de Llano1, Ignacio Dávila2, Eva Martínez-Moragón3, Javier Domínguez-Ortega4, Carlos Almonacid5, Carlos Colás6, Juan Luis García-Rivero7, Loreto Carmona8, María Jesús García de Yébenes8, Borja G Cosío9. 1. Pneumology Service, Hospital Lucus Augusti, EOXI Lugo, Monforte, Cervo, Lugo, Spain. Electronic address: eremos26@hotmail.com. 2. Department of Allergy, University Hospital of Samanca, Salamanca, Spain. 3. Pneumology Service, Hospital Universitario Dr Peset, Valencia, Spain. 4. Allergy Department, La Paz Hospital Institute for Health Research, Madrid, Spain; CIBER of Respiratory Diseases CIBERES, Spain. 5. Pneumology Service, Hospital Ramón y Cajal, Irycis, Madrid, Spain. 6. Hospital Clínico-Instituto de Investigación Sanitaria de Aragón, Zaragoza, Spain. 7. Department of Respiratory Medicine, Hospital de Laredo, Cantabria, Spain. 8. Instituto de Salud Musculoesquelética, Madrid, Spain. 9. Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa-Ciberes, Palma de Mallorca, Spain.
Abstract
BACKGROUND: There is a lack of tools to quantify the response to monoclonal antibodies (mAbs) holistically in severe uncontrolled asthma patients. OBJECTIVE: To develop a valid score to assist specialists in this clinical context. METHODS: The score was developed in four subsequent phases: (1) elaboration of the theoretical model of the construct intended to be measured (response to mAbs); (2) definition and selection of items and measurement instruments by Delphi survey; (3) weight assignment of the selected items by multicriteria decision analysis using the Potentially All Pairwise RanKings of All Possible Alternatives methodology using the 1000minds software; and (4) face validity assessment of the obtained score. RESULTS: Four core items, with different levels of response for each, were selected: severe exacerbations, oral corticosteroid use, symptoms (evaluated by Asthma Control Test), and bronchial obstruction (assessed by FEV1 percent predicted). Severe exacerbations and oral corticosteroid maintenance dose were weighted most heavily (38% each), followed by symptoms (13%) and FEV1 (11%). Higher scores in the weighted system indicate a better response and the range of responses runs from 0 (worsening) to 100 (best possible response). Face validity was high (intraclass correlation coefficient of 0.86). CONCLUSIONS: The FEV1, exacerbations, oral corticosteroids, symptoms score allows clinicians to quantify response in severe uncontrolled asthma patients who are being treated with mAbs.
BACKGROUND: There is a lack of tools to quantify the response to monoclonal antibodies (mAbs) holistically in severe uncontrolled asthmapatients. OBJECTIVE: To develop a valid score to assist specialists in this clinical context. METHODS: The score was developed in four subsequent phases: (1) elaboration of the theoretical model of the construct intended to be measured (response to mAbs); (2) definition and selection of items and measurement instruments by Delphi survey; (3) weight assignment of the selected items by multicriteria decision analysis using the Potentially All Pairwise RanKings of All Possible Alternatives methodology using the 1000minds software; and (4) face validity assessment of the obtained score. RESULTS: Four core items, with different levels of response for each, were selected: severe exacerbations, oral corticosteroid use, symptoms (evaluated by Asthma Control Test), and bronchial obstruction (assessed by FEV1 percent predicted). Severe exacerbations and oral corticosteroid maintenance dose were weighted most heavily (38% each), followed by symptoms (13%) and FEV1 (11%). Higher scores in the weighted system indicate a better response and the range of responses runs from 0 (worsening) to 100 (best possible response). Face validity was high (intraclass correlation coefficient of 0.86). CONCLUSIONS: The FEV1, exacerbations, oral corticosteroids, symptoms score allows clinicians to quantify response in severe uncontrolled asthmapatients who are being treated with mAbs.
Authors: Luis A Pérez de Llano; Borja G Cosío; Ignacio Lobato Astiárraga; Gregorio Soto Campos; Miguel Ángel Tejedor Alonso; Nuria Marina Malanda; Alicia Padilla Galo; Isabel Urrutia Landa; Francisco J Michel de la Rosa; Ismael García-Moguel Journal: J Asthma Allergy Date: 2022-01-14