Primary care COPD patients compared with large pharmaceutically-sponsored COPD studies: an UNLOCK validation study.

<h4>Background</h4>Guideline recommendations for chronic obstructive pulmonary disease (COPD) are based on the results of large pharmaceutically-sponsored COPD studies (LPCS). There is a paucity of data on disease characteristics at the primary care level, while the majority of COPD pati...

Descripción completa

Guardado en:
Detalles Bibliográficos
Autores principales: Annemarije L Kruis, Björn Ställberg, Rupert C M Jones, Ioanna G Tsiligianni, Karin Lisspers, Thys van der Molen, Jan Willem H Kocks, Niels H Chavannes
Formato: article
Lenguaje:EN
Publicado: Public Library of Science (PLoS) 2014
Materias:
R
Q
Acceso en línea:https://doaj.org/article/07cf43723cdb4f9bafecb482e47093c7
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
id oai:doaj.org-article:07cf43723cdb4f9bafecb482e47093c7
record_format dspace
spelling oai:doaj.org-article:07cf43723cdb4f9bafecb482e47093c72021-11-18T08:29:40ZPrimary care COPD patients compared with large pharmaceutically-sponsored COPD studies: an UNLOCK validation study.1932-620310.1371/journal.pone.0090145https://doaj.org/article/07cf43723cdb4f9bafecb482e47093c72014-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24598945/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>Guideline recommendations for chronic obstructive pulmonary disease (COPD) are based on the results of large pharmaceutically-sponsored COPD studies (LPCS). There is a paucity of data on disease characteristics at the primary care level, while the majority of COPD patients are treated in primary care.<h4>Objective</h4>We aimed to evaluate the external validity of six LPCS (ISOLDE, TRISTAN, TORCH, UPLIFT, ECLIPSE, POET-COPD) on which current guidelines are based, in relation to primary care COPD patients, in order to inform future clinical practice guidelines and trials.<h4>Methods</h4>Baseline data of seven primary care databases (n=3508) from Europe were compared to baseline data of the LPCS. In addition, we examined the proportion of primary care patients eligible to participate in the LPCS, based on inclusion criteria.<h4>Results</h4>Overall, patients included in the LPCS were younger (mean difference (MD)-2.4; p=0.03), predominantly male (MD 12.4; p=0.1) with worse lung function (FEV1% MD -16.4; p<0.01) and worse quality of life scores (SGRQ MD 15.8; p=0.01). There were large differences in GOLD stage distribution compared to primary care patients. Mean exacerbation rates were higher in LPCS, with an overrepresentation of patients with ≥ 1 and ≥ 2 exacerbations, although results were not statistically significant. Our findings add to the literature, as we revealed hitherto unknown GOLD I exacerbation characteristics, showing 34% of mild patients had ≥ 1 exacerbations per year and 12% had ≥ 2 exacerbations per year. The proportion of primary care patients eligible for inclusion in LPCS ranged from 17% (TRISTAN) to 42% (ECLIPSE, UPLIFT).<h4>Conclusion</h4>Primary care COPD patients stand out from patients enrolled in LPCS in terms of gender, lung function, quality of life and exacerbations. More research is needed to determine the effect of pharmacological treatment in mild to moderate patients. We encourage future guideline makers to involve primary care populations in their recommendations.Annemarije L KruisBjörn StällbergRupert C M JonesIoanna G TsiligianniKarin LisspersThys van der MolenJan Willem H KocksNiels H ChavannesPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 9, Iss 3, p e90145 (2014)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Annemarije L Kruis
Björn Ställberg
Rupert C M Jones
Ioanna G Tsiligianni
Karin Lisspers
Thys van der Molen
Jan Willem H Kocks
Niels H Chavannes
Primary care COPD patients compared with large pharmaceutically-sponsored COPD studies: an UNLOCK validation study.
description <h4>Background</h4>Guideline recommendations for chronic obstructive pulmonary disease (COPD) are based on the results of large pharmaceutically-sponsored COPD studies (LPCS). There is a paucity of data on disease characteristics at the primary care level, while the majority of COPD patients are treated in primary care.<h4>Objective</h4>We aimed to evaluate the external validity of six LPCS (ISOLDE, TRISTAN, TORCH, UPLIFT, ECLIPSE, POET-COPD) on which current guidelines are based, in relation to primary care COPD patients, in order to inform future clinical practice guidelines and trials.<h4>Methods</h4>Baseline data of seven primary care databases (n=3508) from Europe were compared to baseline data of the LPCS. In addition, we examined the proportion of primary care patients eligible to participate in the LPCS, based on inclusion criteria.<h4>Results</h4>Overall, patients included in the LPCS were younger (mean difference (MD)-2.4; p=0.03), predominantly male (MD 12.4; p=0.1) with worse lung function (FEV1% MD -16.4; p<0.01) and worse quality of life scores (SGRQ MD 15.8; p=0.01). There were large differences in GOLD stage distribution compared to primary care patients. Mean exacerbation rates were higher in LPCS, with an overrepresentation of patients with ≥ 1 and ≥ 2 exacerbations, although results were not statistically significant. Our findings add to the literature, as we revealed hitherto unknown GOLD I exacerbation characteristics, showing 34% of mild patients had ≥ 1 exacerbations per year and 12% had ≥ 2 exacerbations per year. The proportion of primary care patients eligible for inclusion in LPCS ranged from 17% (TRISTAN) to 42% (ECLIPSE, UPLIFT).<h4>Conclusion</h4>Primary care COPD patients stand out from patients enrolled in LPCS in terms of gender, lung function, quality of life and exacerbations. More research is needed to determine the effect of pharmacological treatment in mild to moderate patients. We encourage future guideline makers to involve primary care populations in their recommendations.
format article
author Annemarije L Kruis
Björn Ställberg
Rupert C M Jones
Ioanna G Tsiligianni
Karin Lisspers
Thys van der Molen
Jan Willem H Kocks
Niels H Chavannes
author_facet Annemarije L Kruis
Björn Ställberg
Rupert C M Jones
Ioanna G Tsiligianni
Karin Lisspers
Thys van der Molen
Jan Willem H Kocks
Niels H Chavannes
author_sort Annemarije L Kruis
title Primary care COPD patients compared with large pharmaceutically-sponsored COPD studies: an UNLOCK validation study.
title_short Primary care COPD patients compared with large pharmaceutically-sponsored COPD studies: an UNLOCK validation study.
title_full Primary care COPD patients compared with large pharmaceutically-sponsored COPD studies: an UNLOCK validation study.
title_fullStr Primary care COPD patients compared with large pharmaceutically-sponsored COPD studies: an UNLOCK validation study.
title_full_unstemmed Primary care COPD patients compared with large pharmaceutically-sponsored COPD studies: an UNLOCK validation study.
title_sort primary care copd patients compared with large pharmaceutically-sponsored copd studies: an unlock validation study.
publisher Public Library of Science (PLoS)
publishDate 2014
url https://doaj.org/article/07cf43723cdb4f9bafecb482e47093c7
work_keys_str_mv AT annemarijelkruis primarycarecopdpatientscomparedwithlargepharmaceuticallysponsoredcopdstudiesanunlockvalidationstudy
AT bjornstallberg primarycarecopdpatientscomparedwithlargepharmaceuticallysponsoredcopdstudiesanunlockvalidationstudy
AT rupertcmjones primarycarecopdpatientscomparedwithlargepharmaceuticallysponsoredcopdstudiesanunlockvalidationstudy
AT ioannagtsiligianni primarycarecopdpatientscomparedwithlargepharmaceuticallysponsoredcopdstudiesanunlockvalidationstudy
AT karinlisspers primarycarecopdpatientscomparedwithlargepharmaceuticallysponsoredcopdstudiesanunlockvalidationstudy
AT thysvandermolen primarycarecopdpatientscomparedwithlargepharmaceuticallysponsoredcopdstudiesanunlockvalidationstudy
AT janwillemhkocks primarycarecopdpatientscomparedwithlargepharmaceuticallysponsoredcopdstudiesanunlockvalidationstudy
AT nielshchavannes primarycarecopdpatientscomparedwithlargepharmaceuticallysponsoredcopdstudiesanunlockvalidationstudy
_version_ 1718421723018166272