Repeatability and sensitivity to change of non-invasive end points in PAH: the RESPIRE study

Andrew J. Swift; Frederick Wilson; Marcella Cogliano; Lindsay Kendall; Faisal Alandejani; Samer Alabed; Paul Hughes; Yousef Shahin; Laura Saunders; Charlotte Oram; David Capener; Alex Rothman; Pankaj Garg; Christopher Johns; Matthew Austin; Alistair Macdonald; Jo Pickworth; Peter Hickey; Robin Condliffe; Anthony Cahn; Allan Lawrie; Jim M Wild; David G Kiely

doi:10.1136/thoraxjnl-2020-216078

Repeatability and sensitivity to change of non-invasive end points in PAH: the RESPIRE study

Andrew J. Swift, Frederick Wilson, Marcella Cogliano, Lindsay Kendall, Faisal Alandejani, Samer Alabed, Paul Hughes, Yousef Shahin, Laura Saunders, Charlotte Oram, David Capener, Alex Rothman, Pankaj Garg, Christopher Johns, Matthew Austin, Alistair Macdonald, Jo Pickworth, Peter Hickey, Robin Condliffe, Anthony CahnAllan Lawrie, Jim M Wild, David G Kiely

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Abstract

End points that are repeatable and sensitive to change are important in pulmonary arterial hypertension (PAH) for clinical practice and trials of new therapies. In 42 patients with PAH, test-retest repeatability was assessed using the intraclass correlation coefficient and treatment effect size using Cohen's d statistic. Intraclass correlation coefficients demonstrated excellent repeatability for MRI, 6 min walk test and log to base 10 N-terminal pro-brain natriuretic peptide (log 10 NT-proBNP). The treatment effect size for MRI-derived right ventricular ejection fraction was large (Cohen's d 0.81), whereas the effect size for the 6 min walk test (Cohen's d 0.22) and log 10 NT-proBNP (Cohen's d 0.20) were fair. This study supports further evaluation of MRI as a non-invasive end point for clinical assessment and PAH therapy trials. Trial registration number NCT03841344.

Original language	English
Pages (from-to)	1032-1035
Number of pages	4
Journal	Thorax
Volume	76
Issue number	10
Early online date	25 Feb 2021
DOIs	https://doi.org/10.1136/thoraxjnl-2020-216078
Publication status	Published - 17 Sept 2021

Keywords

imaging/CT MRI etc
primary pulmonary hypertension

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Swift, A. J., Wilson, F., Cogliano, M., Kendall, L., Alandejani, F., Alabed, S., Hughes, P., Shahin, Y., Saunders, L., Oram, C., Capener, D., Rothman, A., Garg, P., Johns, C., Austin, M., Macdonald, A., Pickworth, J., Hickey, P., Condliffe, R., ... Kiely, D. G. (2021). Repeatability and sensitivity to change of non-invasive end points in PAH: the RESPIRE study. Thorax, 76(10), 1032-1035. https://doi.org/10.1136/thoraxjnl-2020-216078

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title = "Repeatability and sensitivity to change of non-invasive end points in PAH: the RESPIRE study",

abstract = "End points that are repeatable and sensitive to change are important in pulmonary arterial hypertension (PAH) for clinical practice and trials of new therapies. In 42 patients with PAH, test-retest repeatability was assessed using the intraclass correlation coefficient and treatment effect size using Cohen's d statistic. Intraclass correlation coefficients demonstrated excellent repeatability for MRI, 6 min walk test and log to base 10 N-terminal pro-brain natriuretic peptide (log 10 NT-proBNP). The treatment effect size for MRI-derived right ventricular ejection fraction was large (Cohen's d 0.81), whereas the effect size for the 6 min walk test (Cohen's d 0.22) and log 10 NT-proBNP (Cohen's d 0.20) were fair. This study supports further evaluation of MRI as a non-invasive end point for clinical assessment and PAH therapy trials. Trial registration number NCT03841344.",

keywords = "imaging/CT MRI etc, primary pulmonary hypertension",

author = "Swift, {Andrew J.} and Frederick Wilson and Marcella Cogliano and Lindsay Kendall and Faisal Alandejani and Samer Alabed and Paul Hughes and Yousef Shahin and Laura Saunders and Charlotte Oram and David Capener and Alex Rothman and Pankaj Garg and Christopher Johns and Matthew Austin and Alistair Macdonald and Jo Pickworth and Peter Hickey and Robin Condliffe and Anthony Cahn and Allan Lawrie and Wild, {Jim M} and Kiely, {David G}",

note = "Funding Information: This study was funded by GlaxoSmithKline (contract number COL100041816) and Wellcome Trust (205188/Z/16/Z and 206632/Z/17/Z). PH is funded by a research grant from GlaxoSmithKline (BIDS3000032592).",

year = "2021",

month = sep,

day = "17",

doi = "10.1136/thoraxjnl-2020-216078",

language = "English",

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Swift, AJ, Wilson, F, Cogliano, M, Kendall, L, Alandejani, F, Alabed, S, Hughes, P, Shahin, Y, Saunders, L, Oram, C, Capener, D, Rothman, A, Garg, P, Johns, C, Austin, M, Macdonald, A, Pickworth, J, Hickey, P, Condliffe, R, Cahn, A, Lawrie, A, Wild, JM & Kiely, DG 2021, 'Repeatability and sensitivity to change of non-invasive end points in PAH: the RESPIRE study', Thorax, vol. 76, no. 10, pp. 1032-1035. https://doi.org/10.1136/thoraxjnl-2020-216078

TY - JOUR

T1 - Repeatability and sensitivity to change of non-invasive end points in PAH: the RESPIRE study

AU - Swift, Andrew J.

AU - Wilson, Frederick

AU - Cogliano, Marcella

AU - Kendall, Lindsay

AU - Alandejani, Faisal

AU - Alabed, Samer

AU - Hughes, Paul

AU - Shahin, Yousef

AU - Saunders, Laura

AU - Oram, Charlotte

AU - Capener, David

AU - Rothman, Alex

AU - Garg, Pankaj

AU - Johns, Christopher

AU - Austin, Matthew

AU - Macdonald, Alistair

AU - Pickworth, Jo

AU - Hickey, Peter

AU - Condliffe, Robin

AU - Cahn, Anthony

AU - Lawrie, Allan

AU - Wild, Jim M

AU - Kiely, David G

N1 - Funding Information: This study was funded by GlaxoSmithKline (contract number COL100041816) and Wellcome Trust (205188/Z/16/Z and 206632/Z/17/Z). PH is funded by a research grant from GlaxoSmithKline (BIDS3000032592).

PY - 2021/9/17

Y1 - 2021/9/17

N2 - End points that are repeatable and sensitive to change are important in pulmonary arterial hypertension (PAH) for clinical practice and trials of new therapies. In 42 patients with PAH, test-retest repeatability was assessed using the intraclass correlation coefficient and treatment effect size using Cohen's d statistic. Intraclass correlation coefficients demonstrated excellent repeatability for MRI, 6 min walk test and log to base 10 N-terminal pro-brain natriuretic peptide (log 10 NT-proBNP). The treatment effect size for MRI-derived right ventricular ejection fraction was large (Cohen's d 0.81), whereas the effect size for the 6 min walk test (Cohen's d 0.22) and log 10 NT-proBNP (Cohen's d 0.20) were fair. This study supports further evaluation of MRI as a non-invasive end point for clinical assessment and PAH therapy trials. Trial registration number NCT03841344.

AB - End points that are repeatable and sensitive to change are important in pulmonary arterial hypertension (PAH) for clinical practice and trials of new therapies. In 42 patients with PAH, test-retest repeatability was assessed using the intraclass correlation coefficient and treatment effect size using Cohen's d statistic. Intraclass correlation coefficients demonstrated excellent repeatability for MRI, 6 min walk test and log to base 10 N-terminal pro-brain natriuretic peptide (log 10 NT-proBNP). The treatment effect size for MRI-derived right ventricular ejection fraction was large (Cohen's d 0.81), whereas the effect size for the 6 min walk test (Cohen's d 0.22) and log 10 NT-proBNP (Cohen's d 0.20) were fair. This study supports further evaluation of MRI as a non-invasive end point for clinical assessment and PAH therapy trials. Trial registration number NCT03841344.

KW - imaging/CT MRI etc

KW - primary pulmonary hypertension

UR - http://www.scopus.com/inward/record.url?scp=85101858104&partnerID=8YFLogxK

U2 - 10.1136/thoraxjnl-2020-216078

DO - 10.1136/thoraxjnl-2020-216078

M3 - Article

SN - 0040-6376

VL - 76

SP - 1032

EP - 1035

JO - Thorax

JF - Thorax

IS - 10

ER -

Repeatability and sensitivity to change of non-invasive end points in PAH: the RESPIRE study

Abstract

Keywords

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