Clinical importance of patient-reported outcome measures in severe asthma: results from U-BIOPRED

Roy Meys; Frits M. E. Franssen; Alex J. Van 't Hul; Per S. Bakke; Massimo Caruso; Barbro Dahlen; Stephen J. Fowler; Thomas Geiser; Peter H. Howarth; Ildiko Horvath; Norbert Krug; Annelie F. Behndig; Florian Singer; Jacek Musial; Dominick E. Shaw; Paolo Montuschi; Anke H. Maitland-van der Zee; Peter J. Sterk; Graham Roberts; Nazanin Z. Kermani; Raffaele A. Incalzi; Renaud Louis; Lars I. Andersson; Scott S. Wagers; Sven-Erik Dahlen; Kian Fan Chung; Ian M. Adcock; Martijn A. Spruit; U-BIOPRED Study Group

doi:10.1186/s12955-024-02321-3

Clinical importance of patient-reported outcome measures in severe asthma: results from U-BIOPRED

Roy Meys^*, Frits M. E. Franssen, Alex J. Van 't Hul, Per S. Bakke, Massimo Caruso, Barbro Dahlen, Stephen J. Fowler, Thomas Geiser, Peter H. Howarth, Ildiko Horvath, Norbert Krug, Annelie F. Behndig, Florian Singer, Jacek Musial, Dominick E. Shaw, Paolo Montuschi, Anke H. Maitland-van der Zee, Peter J. Sterk, Graham Roberts, Nazanin Z. KermaniRaffaele A. Incalzi, Renaud Louis, Lars I. Andersson, Scott S. Wagers, Sven-Erik Dahlen, Kian Fan Chung, Ian M. Adcock, Martijn A. Spruit, U-BIOPRED Study Group

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Rationale Knowledge about the clinical importance of patient-reported outcome measures (PROMs) in severe asthma is limited. Objectives To assess whether and to what extent asthma exacerbations affect changes in PROMS over time and asthma-specific PROMs can predict exacerbations in adult patients with severe asthma in usual care. Methods Data of 421 patients with severe asthma (62% female; mean age 51.9 +/- 13.4 years; mean FEV1 67.5 +/- 21.3%pred) from the U-BIOPRED cohort were analyzed. The included PROMs were: Asthma Control Questionnaire (ACQ5); Asthma Quality of Life Questionnaire (AQLQ); Hospital Anxiety and Depression scale (HADS); Epworth Sleepiness Scale (ESS); Medication Adherence Report Scale (MARS); Sino-Nasal Outcomes Test (SNOT20). Participants were assessed at baseline and after 12-18 months of usual care. Results PROMs showed very weak to weak correlations with clinical characteristics such as age, body mass index, FEV1, FeNO and eosinophilic cell count. Patients presenting no exacerbations during follow-up showed a statistically significant improvement in all PROMs (except for MARS), whereas individuals experiencing > 2 exacerbations showed a deterioration. Baseline ACQ5 was a predictor of exacerbations with an AUC of 0.590 (95%CI 0.514-0.666). Conclusions The association of PROMs with clinical measures was poor in severe asthmatics. Moreover, PROMs were prone to changes in usual care, with exacerbations playing a key role. PROMs need to be systematically evaluated in severe asthma to improve clinical care based on specific patient's needs.

Original language	English
Article number	109
Number of pages	10
Journal	Health and Quality of Life Outcomes
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s12955-024-02321-3
Publication status	Published - 20 Dec 2024

Keywords

Obstructive pulmonary diseases
Patient outcome assessment
Health status
QUALITY-OF-LIFE
EXACERBATIONS
ADHERENCE

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Meys, R., Franssen, F. M. E., Van 't Hul, A. J., Bakke, P. S., Caruso, M., Dahlen, B., Fowler, S. J., Geiser, T., Howarth, P. H., Horvath, I., Krug, N., Behndig, A. F., Singer, F., Musial, J., Shaw, D. E., Montuschi, P., Zee, A. H. M. D., Sterk, P. J., Roberts, G., ... U-BIOPRED Study Group (2024). Clinical importance of patient-reported outcome measures in severe asthma: results from U-BIOPRED. Health and Quality of Life Outcomes, 22(1), Article 109. https://doi.org/10.1186/s12955-024-02321-3

@article{beba4a0c185140519aa6ad3cdf281702,

title = "Clinical importance of patient-reported outcome measures in severe asthma: results from U-BIOPRED",

abstract = "Rationale Knowledge about the clinical importance of patient-reported outcome measures (PROMs) in severe asthma is limited. Objectives To assess whether and to what extent asthma exacerbations affect changes in PROMS over time and asthma-specific PROMs can predict exacerbations in adult patients with severe asthma in usual care. Methods Data of 421 patients with severe asthma (62% female; mean age 51.9 +/- 13.4 years; mean FEV1 67.5 +/- 21.3%pred) from the U-BIOPRED cohort were analyzed. The included PROMs were: Asthma Control Questionnaire (ACQ5); Asthma Quality of Life Questionnaire (AQLQ); Hospital Anxiety and Depression scale (HADS); Epworth Sleepiness Scale (ESS); Medication Adherence Report Scale (MARS); Sino-Nasal Outcomes Test (SNOT20). Participants were assessed at baseline and after 12-18 months of usual care. Results PROMs showed very weak to weak correlations with clinical characteristics such as age, body mass index, FEV1, FeNO and eosinophilic cell count. Patients presenting no exacerbations during follow-up showed a statistically significant improvement in all PROMs (except for MARS), whereas individuals experiencing > 2 exacerbations showed a deterioration. Baseline ACQ5 was a predictor of exacerbations with an AUC of 0.590 (95%CI 0.514-0.666). Conclusions The association of PROMs with clinical measures was poor in severe asthmatics. Moreover, PROMs were prone to changes in usual care, with exacerbations playing a key role. PROMs need to be systematically evaluated in severe asthma to improve clinical care based on specific patient's needs.",

keywords = "Obstructive pulmonary diseases, Patient outcome assessment, Health status, QUALITY-OF-LIFE, EXACERBATIONS, ADHERENCE",

author = "Roy Meys and Franssen, {Frits M. E.} and {Van 't Hul}, {Alex J.} and Bakke, {Per S.} and Massimo Caruso and Barbro Dahlen and Fowler, {Stephen J.} and Thomas Geiser and Howarth, {Peter H.} and Ildiko Horvath and Norbert Krug and Behndig, {Annelie F.} and Florian Singer and Jacek Musial and Shaw, {Dominick E.} and Paolo Montuschi and Zee, {Anke H. Maitland-van der} and Sterk, {Peter J.} and Graham Roberts and Kermani, {Nazanin Z.} and Incalzi, {Raffaele A.} and Renaud Louis and Andersson, {Lars I.} and Wagers, {Scott S.} and Sven-Erik Dahlen and Chung, {Kian Fan} and Adcock, {Ian M.} and Spruit, {Martijn A.} and {U-BIOPRED Study Group}",

year = "2024",

month = dec,

day = "20",

doi = "10.1186/s12955-024-02321-3",

language = "English",

volume = "22",

journal = "Health and Quality of Life Outcomes",

issn = "1477-7525",

publisher = "BioMed Central Ltd",

number = "1",

}

Meys, R, Franssen, FME, Van 't Hul, AJ, Bakke, PS, Caruso, M, Dahlen, B, Fowler, SJ, Geiser, T, Howarth, PH, Horvath, I, Krug, N, Behndig, AF, Singer, F, Musial, J, Shaw, DE, Montuschi, P, Zee, AHMD, Sterk, PJ, Roberts, G, Kermani, NZ, Incalzi, RA, Louis, R, Andersson, LI, Wagers, SS, Dahlen, S-E, Chung, KF, Adcock, IM, Spruit, MA & U-BIOPRED Study Group 2024, 'Clinical importance of patient-reported outcome measures in severe asthma: results from U-BIOPRED', Health and Quality of Life Outcomes, vol. 22, no. 1, 109. https://doi.org/10.1186/s12955-024-02321-3

TY - JOUR

T1 - Clinical importance of patient-reported outcome measures in severe asthma

T2 - results from U-BIOPRED

AU - Meys, Roy

AU - Franssen, Frits M. E.

AU - Van 't Hul, Alex J.

AU - Bakke, Per S.

AU - Caruso, Massimo

AU - Dahlen, Barbro

AU - Fowler, Stephen J.

AU - Geiser, Thomas

AU - Howarth, Peter H.

AU - Horvath, Ildiko

AU - Krug, Norbert

AU - Behndig, Annelie F.

AU - Singer, Florian

AU - Musial, Jacek

AU - Shaw, Dominick E.

AU - Montuschi, Paolo

AU - Zee, Anke H. Maitland-van der

AU - Sterk, Peter J.

AU - Roberts, Graham

AU - Kermani, Nazanin Z.

AU - Incalzi, Raffaele A.

AU - Louis, Renaud

AU - Andersson, Lars I.

AU - Wagers, Scott S.

AU - Dahlen, Sven-Erik

AU - Chung, Kian Fan

AU - Adcock, Ian M.

AU - Spruit, Martijn A.

AU - U-BIOPRED Study Group

PY - 2024/12/20

Y1 - 2024/12/20

N2 - Rationale Knowledge about the clinical importance of patient-reported outcome measures (PROMs) in severe asthma is limited. Objectives To assess whether and to what extent asthma exacerbations affect changes in PROMS over time and asthma-specific PROMs can predict exacerbations in adult patients with severe asthma in usual care. Methods Data of 421 patients with severe asthma (62% female; mean age 51.9 +/- 13.4 years; mean FEV1 67.5 +/- 21.3%pred) from the U-BIOPRED cohort were analyzed. The included PROMs were: Asthma Control Questionnaire (ACQ5); Asthma Quality of Life Questionnaire (AQLQ); Hospital Anxiety and Depression scale (HADS); Epworth Sleepiness Scale (ESS); Medication Adherence Report Scale (MARS); Sino-Nasal Outcomes Test (SNOT20). Participants were assessed at baseline and after 12-18 months of usual care. Results PROMs showed very weak to weak correlations with clinical characteristics such as age, body mass index, FEV1, FeNO and eosinophilic cell count. Patients presenting no exacerbations during follow-up showed a statistically significant improvement in all PROMs (except for MARS), whereas individuals experiencing > 2 exacerbations showed a deterioration. Baseline ACQ5 was a predictor of exacerbations with an AUC of 0.590 (95%CI 0.514-0.666). Conclusions The association of PROMs with clinical measures was poor in severe asthmatics. Moreover, PROMs were prone to changes in usual care, with exacerbations playing a key role. PROMs need to be systematically evaluated in severe asthma to improve clinical care based on specific patient's needs.

AB - Rationale Knowledge about the clinical importance of patient-reported outcome measures (PROMs) in severe asthma is limited. Objectives To assess whether and to what extent asthma exacerbations affect changes in PROMS over time and asthma-specific PROMs can predict exacerbations in adult patients with severe asthma in usual care. Methods Data of 421 patients with severe asthma (62% female; mean age 51.9 +/- 13.4 years; mean FEV1 67.5 +/- 21.3%pred) from the U-BIOPRED cohort were analyzed. The included PROMs were: Asthma Control Questionnaire (ACQ5); Asthma Quality of Life Questionnaire (AQLQ); Hospital Anxiety and Depression scale (HADS); Epworth Sleepiness Scale (ESS); Medication Adherence Report Scale (MARS); Sino-Nasal Outcomes Test (SNOT20). Participants were assessed at baseline and after 12-18 months of usual care. Results PROMs showed very weak to weak correlations with clinical characteristics such as age, body mass index, FEV1, FeNO and eosinophilic cell count. Patients presenting no exacerbations during follow-up showed a statistically significant improvement in all PROMs (except for MARS), whereas individuals experiencing > 2 exacerbations showed a deterioration. Baseline ACQ5 was a predictor of exacerbations with an AUC of 0.590 (95%CI 0.514-0.666). Conclusions The association of PROMs with clinical measures was poor in severe asthmatics. Moreover, PROMs were prone to changes in usual care, with exacerbations playing a key role. PROMs need to be systematically evaluated in severe asthma to improve clinical care based on specific patient's needs.

KW - Obstructive pulmonary diseases

KW - Patient outcome assessment

KW - Health status

KW - QUALITY-OF-LIFE

KW - EXACERBATIONS

KW - ADHERENCE

U2 - 10.1186/s12955-024-02321-3

DO - 10.1186/s12955-024-02321-3

M3 - Article

SN - 1477-7525

VL - 22

JO - Health and Quality of Life Outcomes

JF - Health and Quality of Life Outcomes

IS - 1

M1 - 109

ER -

Clinical importance of patient-reported outcome measures in severe asthma: results from U-BIOPRED

Abstract

Keywords

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