Clinimetric properties of outcome measures in bronchiectasis

Judy M. Bradley; Kathryn Ferguson; Andrew Bailey; Katherine O'Neill; Rebecca H. McLeese; Adam T Hill; Michael R. Loebinger; Mary Carroll; James D. Chalmers; Timothy Gatheral; Christopher Johnson; Anthony De Soyza; John R. Hurst; Damian G. Downey; J. Stuart Elborn

doi:10.1513/AnnalsATS.202206-493OC

Clinimetric properties of outcome measures in bronchiectasis

Judy M. Bradley, Kathryn Ferguson, Andrew Bailey, Katherine O'Neill, Rebecca H. McLeese, Adam T Hill, Michael R. Loebinger, Mary Carroll, James D. Chalmers, Timothy Gatheral, Christopher Johnson, Anthony De Soyza, John R. Hurst, Damian G. Downey, J. Stuart Elborn

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1 Citation (Scopus)

Abstract

Rationale: There is a lack of outcome measures with robust clinimetric properties in bronchiectasis. Objectives: To determine the clinimetric properties (reliability over 1 year during clinical stability and responsiveness over the course of antibiotics for pulmonary exacerbation) of objective and patient-reported outcome measures. Methods: This multicenter cohort study included adults with bronchiectasis from seven hospitals in the United Kingdom. Participants attended four visits, 4 months apart over 1 year while clinically stable and at the beginning and end of exacerbation and completed lung function (spirometry and multiple breath washout), provided a blood sample for C-reactive protein (CRP) measurement, and completed health-related quality of life (HRQoL) questionnaires (Quality of Life-Bronchiectasis, St. George’s Respiratory Questionnaire, and EuroQoL 5-Dimensions 5-Levels). Results: Participants (n = 132) had a mean (standard deviation) age of 66 (11) years, and 64% were female. Lung function parameters (forced expiratory volume in one second [FEV ₁], standard lung clearance index [LCI ^2.5]) were reliable over time [coefficient of variation (CV):,10%]). Regarding responsiveness, FEV ₁ demonstrated better properties than LCI ^2.5; therefore, a clear justification for the use of LCI ^2.5 in future trials is needed. CRP was less reliable (CV . 20%) over time than FEV ₁ and LCI ^2.5, and whereas CRP had a large mean change between the start and end of an exacerbation, this may have been driven by a small number of patients having a large change in CRP. Reliability of HRQoL questionnaires and questionnaire domains ranged from acceptable (CV: 20–30%) to good (CV: 10–20%), and HRQoL were responsive to treatment of exacerbations. Considering the specific questionnaire domain relevant to the intervention and its associated clinimetric properties is important. Additional statistics will support future power and/or sample size analysis. Conclusions: This information on the clinimetric properties of lung function parameters, CRP, and HRQoL parameters should be used to inform the choice of outcome measures used in future bronchiectasis trials.

Original language	English
Pages (from-to)	648-659
Number of pages	12
Journal	Annals of the American Thoracic Society
Volume	20
Issue number	5
DOIs	https://doi.org/10.1513/AnnalsATS.202206-493OC
Publication status	Published - May 2023

Keywords

bronchiectasis
clinimetrics
outcome measures

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10.1513/AnnalsATS.202206-493OC

Inhaled Antibiotics in Bronchiectasis and Cystic Fibrosis (iABC) (Joint with 19 Partners)
Chalmers, J. (Investigator) & Shoemark, A. (Investigator)
COMMISSION OF THE EUROPEAN COMMUNITIES
1/09/15 → 30/06/23
Project: Research

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Bradley, J. M., Ferguson, K., Bailey, A., O'Neill, K., McLeese, R. H., Hill, A. T., Loebinger, M. R., Carroll, M., Chalmers, J. D., Gatheral, T., Johnson, C., De Soyza, A., Hurst, J. R., Downey, D. G., & Elborn, J. S. (2023). Clinimetric properties of outcome measures in bronchiectasis. Annals of the American Thoracic Society, 20(5), 648-659. https://doi.org/10.1513/AnnalsATS.202206-493OC

@article{0588ac5c2d3c4c0ea1185d68748d3ae1,

title = "Clinimetric properties of outcome measures in bronchiectasis",

abstract = "Rationale: There is a lack of outcome measures with robust clinimetric properties in bronchiectasis. Objectives: To determine the clinimetric properties (reliability over 1 year during clinical stability and responsiveness over the course of antibiotics for pulmonary exacerbation) of objective and patient-reported outcome measures. Methods: This multicenter cohort study included adults with bronchiectasis from seven hospitals in the United Kingdom. Participants attended four visits, 4 months apart over 1 year while clinically stable and at the beginning and end of exacerbation and completed lung function (spirometry and multiple breath washout), provided a blood sample for C-reactive protein (CRP) measurement, and completed health-related quality of life (HRQoL) questionnaires (Quality of Life-Bronchiectasis, St. George{\textquoteright}s Respiratory Questionnaire, and EuroQoL 5-Dimensions 5-Levels). Results: Participants (n = 132) had a mean (standard deviation) age of 66 (11) years, and 64% were female. Lung function parameters (forced expiratory volume in one second [FEV 1], standard lung clearance index [LCI 2.5]) were reliable over time [coefficient of variation (CV):,10%]). Regarding responsiveness, FEV 1 demonstrated better properties than LCI 2.5; therefore, a clear justification for the use of LCI 2.5 in future trials is needed. CRP was less reliable (CV . 20%) over time than FEV 1 and LCI 2.5, and whereas CRP had a large mean change between the start and end of an exacerbation, this may have been driven by a small number of patients having a large change in CRP. Reliability of HRQoL questionnaires and questionnaire domains ranged from acceptable (CV: 20–30%) to good (CV: 10–20%), and HRQoL were responsive to treatment of exacerbations. Considering the specific questionnaire domain relevant to the intervention and its associated clinimetric properties is important. Additional statistics will support future power and/or sample size analysis. Conclusions: This information on the clinimetric properties of lung function parameters, CRP, and HRQoL parameters should be used to inform the choice of outcome measures used in future bronchiectasis trials.",

keywords = "bronchiectasis, clinimetrics, outcome measures",

author = "Bradley, {Judy M.} and Kathryn Ferguson and Andrew Bailey and Katherine O'Neill and McLeese, {Rebecca H.} and Hill, {Adam T} and Loebinger, {Michael R.} and Mary Carroll and Chalmers, {James D.} and Timothy Gatheral and Christopher Johnson and {De Soyza}, Anthony and Hurst, {John R.} and Downey, {Damian G.} and Elborn, {J. Stuart}",

note = "Funding Information: Supported by the BronchUK consortium (www.bronch.ac.uk), which is supported by the Medical Research Council (grant MR/L011263/1). The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement 115721, resources that are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007–2013) and EFPIA companies{\textquoteright} in-kind contribution.",

year = "2023",

month = may,

doi = "10.1513/AnnalsATS.202206-493OC",

language = "English",

volume = "20",

pages = "648--659",

journal = "Annals of the American Thoracic Society",

issn = "2325-6621",

publisher = "American Thoracic Society",

number = "5",

}

Bradley, JM, Ferguson, K, Bailey, A, O'Neill, K, McLeese, RH, Hill, AT, Loebinger, MR, Carroll, M, Chalmers, JD, Gatheral, T, Johnson, C, De Soyza, A, Hurst, JR, Downey, DG & Elborn, JS 2023, 'Clinimetric properties of outcome measures in bronchiectasis', Annals of the American Thoracic Society, vol. 20, no. 5, pp. 648-659. https://doi.org/10.1513/AnnalsATS.202206-493OC

TY - JOUR

T1 - Clinimetric properties of outcome measures in bronchiectasis

AU - Bradley, Judy M.

AU - Ferguson, Kathryn

AU - Bailey, Andrew

AU - O'Neill, Katherine

AU - McLeese, Rebecca H.

AU - Hill, Adam T

AU - Loebinger, Michael R.

AU - Carroll, Mary

AU - Chalmers, James D.

AU - Gatheral, Timothy

AU - Johnson, Christopher

AU - De Soyza, Anthony

AU - Hurst, John R.

AU - Downey, Damian G.

AU - Elborn, J. Stuart

N1 - Funding Information: Supported by the BronchUK consortium (www.bronch.ac.uk), which is supported by the Medical Research Council (grant MR/L011263/1). The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement 115721, resources that are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007–2013) and EFPIA companies’ in-kind contribution.

PY - 2023/5

Y1 - 2023/5

N2 - Rationale: There is a lack of outcome measures with robust clinimetric properties in bronchiectasis. Objectives: To determine the clinimetric properties (reliability over 1 year during clinical stability and responsiveness over the course of antibiotics for pulmonary exacerbation) of objective and patient-reported outcome measures. Methods: This multicenter cohort study included adults with bronchiectasis from seven hospitals in the United Kingdom. Participants attended four visits, 4 months apart over 1 year while clinically stable and at the beginning and end of exacerbation and completed lung function (spirometry and multiple breath washout), provided a blood sample for C-reactive protein (CRP) measurement, and completed health-related quality of life (HRQoL) questionnaires (Quality of Life-Bronchiectasis, St. George’s Respiratory Questionnaire, and EuroQoL 5-Dimensions 5-Levels). Results: Participants (n = 132) had a mean (standard deviation) age of 66 (11) years, and 64% were female. Lung function parameters (forced expiratory volume in one second [FEV 1], standard lung clearance index [LCI 2.5]) were reliable over time [coefficient of variation (CV):,10%]). Regarding responsiveness, FEV 1 demonstrated better properties than LCI 2.5; therefore, a clear justification for the use of LCI 2.5 in future trials is needed. CRP was less reliable (CV . 20%) over time than FEV 1 and LCI 2.5, and whereas CRP had a large mean change between the start and end of an exacerbation, this may have been driven by a small number of patients having a large change in CRP. Reliability of HRQoL questionnaires and questionnaire domains ranged from acceptable (CV: 20–30%) to good (CV: 10–20%), and HRQoL were responsive to treatment of exacerbations. Considering the specific questionnaire domain relevant to the intervention and its associated clinimetric properties is important. Additional statistics will support future power and/or sample size analysis. Conclusions: This information on the clinimetric properties of lung function parameters, CRP, and HRQoL parameters should be used to inform the choice of outcome measures used in future bronchiectasis trials.

AB - Rationale: There is a lack of outcome measures with robust clinimetric properties in bronchiectasis. Objectives: To determine the clinimetric properties (reliability over 1 year during clinical stability and responsiveness over the course of antibiotics for pulmonary exacerbation) of objective and patient-reported outcome measures. Methods: This multicenter cohort study included adults with bronchiectasis from seven hospitals in the United Kingdom. Participants attended four visits, 4 months apart over 1 year while clinically stable and at the beginning and end of exacerbation and completed lung function (spirometry and multiple breath washout), provided a blood sample for C-reactive protein (CRP) measurement, and completed health-related quality of life (HRQoL) questionnaires (Quality of Life-Bronchiectasis, St. George’s Respiratory Questionnaire, and EuroQoL 5-Dimensions 5-Levels). Results: Participants (n = 132) had a mean (standard deviation) age of 66 (11) years, and 64% were female. Lung function parameters (forced expiratory volume in one second [FEV 1], standard lung clearance index [LCI 2.5]) were reliable over time [coefficient of variation (CV):,10%]). Regarding responsiveness, FEV 1 demonstrated better properties than LCI 2.5; therefore, a clear justification for the use of LCI 2.5 in future trials is needed. CRP was less reliable (CV . 20%) over time than FEV 1 and LCI 2.5, and whereas CRP had a large mean change between the start and end of an exacerbation, this may have been driven by a small number of patients having a large change in CRP. Reliability of HRQoL questionnaires and questionnaire domains ranged from acceptable (CV: 20–30%) to good (CV: 10–20%), and HRQoL were responsive to treatment of exacerbations. Considering the specific questionnaire domain relevant to the intervention and its associated clinimetric properties is important. Additional statistics will support future power and/or sample size analysis. Conclusions: This information on the clinimetric properties of lung function parameters, CRP, and HRQoL parameters should be used to inform the choice of outcome measures used in future bronchiectasis trials.

KW - bronchiectasis

KW - clinimetrics

KW - outcome measures

U2 - 10.1513/AnnalsATS.202206-493OC

DO - 10.1513/AnnalsATS.202206-493OC

M3 - Article

C2 - 36548542

SN - 2325-6621

VL - 20

SP - 648

EP - 659

JO - Annals of the American Thoracic Society

JF - Annals of the American Thoracic Society

IS - 5

ER -

Clinimetric properties of outcome measures in bronchiectasis

Abstract

Keywords

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Inhaled Antibiotics in Bronchiectasis and Cystic Fibrosis (iABC) (Joint with 19 Partners)

Cite this