Abstract
BACKGROUND: Correct inhaler use depends on a complex interplay of factors, including device preparation and generating sufficient inspiratory flow. It is currently unknown which inhalation technique errors can be considered critical in Chronic Obstructive Pulmonary Disease (COPD) patients on Dry Powder Inhaler (DPI) maintenance therapy.
OBJECTIVE: To investigate the association between inhalation technique errors and health status or exacerbations in patients with COPD. Additionally, the association between the number of errors and COPD outcomes was determined.
METHODS: The PIFotal study is a cross-sectional multi-country observational study in a primary care setting, including 1434 COPD patients aged ≥ 40 years (50.1% female; mean age 69.2 yrs) using a DPI for their maintenance therapy. Inhalation technique was video recorded and scored by two independent researchers using inhaler-specific checklists. Health status was assessed with two questionnaires; the Clinical COPD Questionnaire (CCQ) and the COPD Assessment Test (CAT). The number of moderate and severe exacerbations in the past 12 months was recorded. Critical errors were identified based on their association with health status or exacerbations through multi-level prediction models adjusted for identified confounding.
RESULTS: Errors in inhalation technique steps 'Breathe in', 'Hold breath', and 'Breathe out calmly after inhalation' were significantly associated with poorer CCQ and CAT outcomes and thus deemed critical. None of the errors were significantly associated with moderate exacerbations. Patients with errors 'Preparation', 'Hold inhaler in correct position during inhalation', and 'Breathe in' had significantly more severe exacerbations, and therefore these errors were also deemed critical. 81.3% of patients with COPD made at least one critical error. Specific combinations of errors were associated with worse outcomes. The more inhalation technique errors identified, the poorer the health status and the higher the exacerbation rate.
CONCLUSION: In this study, we identified multiple critical inhalation technique errors in COPD patients using DPIs each associated with poorer outcomes. Explorative analysis revealed that specific combinations of errors may be of clinical relevance, especially those related to the inhalation manoeuvre. COPD outcomes worsened with increasing error count. These results warrant further prospective longitudinal studies to establish the effect of correcting these errors on COPD control.
TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT04532853 (31/08/2020).
| Original language | English |
|---|---|
| Article number | 302 |
| Number of pages | 15 |
| Journal | BMC Pulmonary Medicine |
| Volume | 23 |
| Issue number | 1 |
| Early online date | 17 Aug 2023 |
| DOIs | |
| Publication status | Published - 17 Aug 2023 |
Bibliographical note
AcknowledgementsThe members of the PIFotal study group would like to acknowledge Dr. Judith Cohen and Dr. Wilma Zijlema for their assistance with the review, drafting and editing of the paper, and Dr. Hans Wouters for his contribution to the project administration in the initial phase of the project.
They would also like to thank all contributing researchers: Maria João Barbosa, Ana Margarida Cruz, Liliana Silva, Duarte Araújo, Eurico Silva, Daniel Castro, João Ramires, Ana Fernandes, Catarina Carvalho, Raquel Castro, Jerzy Zientek, Ewa Pasko, Witold Drzastwa, Tomasz Kachel, Kornelia Ciekalska, Krzysztof Wytrychowski, Bernard Panaszek, Krzysztof Kowal, Ebian Brill, Willemien Feenstra, Geert Struik, Hans Schuurman, Mariette van Oostrum, Hennie Holwerda Meekma, Boudewijn Dierick, George Amofa, Esther Kuipers, Lennard Ringnalda, Boris Tyndall, Mark Drenth, Peter Mast, Hilbert Talsma, Raoul Wolfs, Cobie Hoogeboom, Hanneke van Andel, Paul Stoutenberg, Nancy van de Laak, Tessa Hillaert, Laura Holtzer, Natascha Fehrmann, Anniek Makkinga – Maassen van den Brink, Annemarie Hilbink, Erik Feenstra, Murat Tek, Sabrina Burer, Jan van Ginkel, Rinze Boersma, Alyssa Bonger, Miguel Roman Rodriguez, Marina García Pardo, Alejandra Valero Suau, Laura López Velasco, Cecilia Amato, Francisco Palmer Simó, Alberto Abenza, Rosa Llull Vila, Bartolomé Llompart Van Belzen, Silvia Jimeno Martínez, Francesc Moranta Ribas, Margarita Perelló Oliver, Yolanda Gómez López, Patricia Ibañez Gómez, María Nieves Mendieta Lagos, Laura Bueno López, Virginia María Mirabal Sánchez, Ana Delia Rodríguez Delgado, Nils Fischer, Alicia González Sansó, Nayra Ramírez Mendoza, Valeria Gazzaneo, Paula Merced Guillama Rodríguez, Virginia Naranjo Guerrero, Jose Angel Suarez Caballero, Isidoro Souto Bethencourt, Juan R. Dominguez Beatell, Elena Vanesa Rojas Manrique, Maria Jose Sanz Orejas, Cary Perez Lorenzo, Jesús Antonio Pérez Jiménez, Silvia Lara Afonso Trujillo, Bartolomé Dominguez Del Río Boada, Stavroula Papageorgakopoulou, Eleytheria Vakouti, Claire Gkatzoudi, Thodoris Krasanakis, Dimitris Kounalakis , Izoldi Bouloukaki , Nikolaos Tsakountakis, Emmanouela Chronaki, Katherine Mary Borg and Kamila Abutalieva for their time and efforts to perform the study measurements and complete patient inclusion, even in the challenging times of the pandemic.
Finally, they would like to thank the participants who generously gave their time to participate in the study.
Funding
The study sponsor was the General Practitioners Research Institute; data collection and analysis were performed by General Practitioners Research Institute. Boehringer Ingelheim was the funding and scientific partner.
Keywords
- Female
- Male
- Humans
- Dry Powder Inhalers
- Cross-Sectional Studies
- Pulmonary Disease, Chronic Obstructive/drug therapy
- Health Status
- Checklist