Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice Checklist

Background: Inhaled medications are central to treating asthma and chronic obstructive pulmonary disease (COPD), yet critical inhaler technique errors are made by up to 90% of patients. In the clinical research setting, recruitment of subjects with poor inhaler technique may give a false impression...

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Autores: Dekhuijzen, Richard, Levy, Mark L, Corrigan, Chris J, Hadfield, Ruth M, Roche, Nicolas, Usmani, Omar S, Barnes, Peter J, Scullion, Jane E, Lavorini, Federico, Corbetta, Lorenzo, Kocks, Janwillem WH, García-Cosío, Borja, Buhl, Roland, Pedersen, Søren E
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Instituto de Salud Carlos III (ISCIII)
Repositorio:Repisalud
Idioma:inglés
OAI Identifier:oai:repisalud.isciii.es:20.500.12105/23467
Acceso en línea:https://hdl.handle.net/20.500.12105/23467
Access Level:acceso abierto
Palabra clave:Enfermedad Pulmonar Obstructiva Crónica
Humanos
Asma
Lista de Verificación
Administración por Inhalación
Nebulizadores y Vaporizadores
Checklist
Asthma
Nebulizers and Vaporizers
Administration, Inhalation
Pulmonary Disease, Chronic Obstructive
Humans
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spelling Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice ChecklistDekhuijzen, RichardLevy, Mark LCorrigan, Chris JHadfield, Ruth MRoche, NicolasUsmani, Omar SBarnes, Peter JScullion, Jane ELavorini, FedericoCorbetta, LorenzoKocks, Janwillem WHGarcía-Cosío, BorjaBuhl, RolandPedersen, Søren EEnfermedad Pulmonar Obstructiva CrónicaHumanosAsmaLista de VerificaciónAdministración por InhalaciónNebulizadores y VaporizadoresChecklistAsthmaNebulizers and VaporizersAdministration, InhalationPulmonary Disease, Chronic ObstructiveHumansBackground: Inhaled medications are central to treating asthma and chronic obstructive pulmonary disease (COPD), yet critical inhaler technique errors are made by up to 90% of patients. In the clinical research setting, recruitment of subjects with poor inhaler technique may give a false impression of both the benefits and the necessity of add-on treatments such as biologic therapies. Objective: To assess the frequency with which inhaler technique is assessed and reliably optimized before and during patient enrollment into randomized controlled trials (RCTs) addressing the efficacy of topical therapy, and the escalation of therapy for asthma and COPD. Methods: Systematic searches were conducted of PubMed and Embase for RCTs published in the past 10 years involving patients with a diagnosis of asthma or COPD undergoing escalation of baseline inhaled therapy (stepping up, changing, adding, switching, increasing, etc) or the introduction of biologic agents. Results: Searches highlighted 1,014 studies, 118 of which were eligible after the removal of duplicates as well as screening and full text review. Of these, only 14 (11.9%) included accessible information in the methods section or referred to such information in online supplements or protocols concerning assessment of participants' inhaler technique. We therefore developed the proposed Best Practice Inhaler Technique Assessment and Reporting Checklist. Conclusions: Our study identifies a concerning lack of checking and correcting inhaler technique, or at least reporting that this was undertaken, before enrollment in asthma and COPD RCTs, which may affect the conclusions drawn. Mandating the use of a standardized checklist in RCT protocols and ensuring all published RCTs report checking and correcting inhaler technique before enrollment are important next steps.Elsevier20242024-10-0420222022-07-0120222022-07-01research articlehttp://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articlehttps://hdl.handle.net/20.500.12105/23467reponame:Repisaludinstname:Instituto de Salud Carlos III (ISCIII)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:repisalud.isciii.es:20.500.12105/234672026-06-12T12:43:37Z
dc.title.none.fl_str_mv Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice Checklist
title Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice Checklist
spellingShingle Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice Checklist
Dekhuijzen, Richard
Enfermedad Pulmonar Obstructiva Crónica
Humanos
Asma
Lista de Verificación
Administración por Inhalación
Nebulizadores y Vaporizadores
Checklist
Asthma
Nebulizers and Vaporizers
Administration, Inhalation
Pulmonary Disease, Chronic Obstructive
Humans
title_short Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice Checklist
title_full Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice Checklist
title_fullStr Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice Checklist
title_full_unstemmed Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice Checklist
title_sort Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice Checklist
dc.creator.none.fl_str_mv Dekhuijzen, Richard
Levy, Mark L
Corrigan, Chris J
Hadfield, Ruth M
Roche, Nicolas
Usmani, Omar S
Barnes, Peter J
Scullion, Jane E
Lavorini, Federico
Corbetta, Lorenzo
Kocks, Janwillem WH
García-Cosío, Borja
Buhl, Roland
Pedersen, Søren E
author Dekhuijzen, Richard
author_facet Dekhuijzen, Richard
Levy, Mark L
Corrigan, Chris J
Hadfield, Ruth M
Roche, Nicolas
Usmani, Omar S
Barnes, Peter J
Scullion, Jane E
Lavorini, Federico
Corbetta, Lorenzo
Kocks, Janwillem WH
García-Cosío, Borja
Buhl, Roland
Pedersen, Søren E
author_role author
author2 Levy, Mark L
Corrigan, Chris J
Hadfield, Ruth M
Roche, Nicolas
Usmani, Omar S
Barnes, Peter J
Scullion, Jane E
Lavorini, Federico
Corbetta, Lorenzo
Kocks, Janwillem WH
García-Cosío, Borja
Buhl, Roland
Pedersen, Søren E
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv
dc.subject.none.fl_str_mv Enfermedad Pulmonar Obstructiva Crónica
Humanos
Asma
Lista de Verificación
Administración por Inhalación
Nebulizadores y Vaporizadores
Checklist
Asthma
Nebulizers and Vaporizers
Administration, Inhalation
Pulmonary Disease, Chronic Obstructive
Humans
topic Enfermedad Pulmonar Obstructiva Crónica
Humanos
Asma
Lista de Verificación
Administración por Inhalación
Nebulizadores y Vaporizadores
Checklist
Asthma
Nebulizers and Vaporizers
Administration, Inhalation
Pulmonary Disease, Chronic Obstructive
Humans
description Background: Inhaled medications are central to treating asthma and chronic obstructive pulmonary disease (COPD), yet critical inhaler technique errors are made by up to 90% of patients. In the clinical research setting, recruitment of subjects with poor inhaler technique may give a false impression of both the benefits and the necessity of add-on treatments such as biologic therapies. Objective: To assess the frequency with which inhaler technique is assessed and reliably optimized before and during patient enrollment into randomized controlled trials (RCTs) addressing the efficacy of topical therapy, and the escalation of therapy for asthma and COPD. Methods: Systematic searches were conducted of PubMed and Embase for RCTs published in the past 10 years involving patients with a diagnosis of asthma or COPD undergoing escalation of baseline inhaled therapy (stepping up, changing, adding, switching, increasing, etc) or the introduction of biologic agents. Results: Searches highlighted 1,014 studies, 118 of which were eligible after the removal of duplicates as well as screening and full text review. Of these, only 14 (11.9%) included accessible information in the methods section or referred to such information in online supplements or protocols concerning assessment of participants' inhaler technique. We therefore developed the proposed Best Practice Inhaler Technique Assessment and Reporting Checklist. Conclusions: Our study identifies a concerning lack of checking and correcting inhaler technique, or at least reporting that this was undertaken, before enrollment in asthma and COPD RCTs, which may affect the conclusions drawn. Mandating the use of a standardized checklist in RCT protocols and ensuring all published RCTs report checking and correcting inhaler technique before enrollment are important next steps.
publishDate 2022
dc.date.none.fl_str_mv 2022
2022-07-01
2022
2022-07-01
2024
2024-10-04
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.12105/23467
url https://hdl.handle.net/20.500.12105/23467
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:Repisalud
instname:Instituto de Salud Carlos III (ISCIII)
instname_str Instituto de Salud Carlos III (ISCIII)
reponame_str Repisalud
collection Repisalud
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869419969382449153
score 15,198674

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