Validation of Video Supported Spirometry in a Severe Asthma Patient Cohort from the BenRex Study

<bold>Background:</bold> The COVID-19 pandemic escalated the need for remote study procedures in clinical trials. Adaptations to the BenRex Study (Benralizumab Exacerbation Study) allowed for validation of video supported home spirometry against on site face-to-face sessions in severe asthma patients. <bold>Methods:</bold> At screening, participants received a Micro spirometer [Vitalograph, Buckingham, UK] and education on its use. A spirometry session was performed on site with face-to-face coaching from study staff, followed by a remote spirometry session within 24 hours, with coaching over video link at 3 visits. All Spirometry sessions had an over-read for quality assessment, by Respiratory Physiologists at Vitalograph, using the grading system per the ATS-ERS 2019 Standardisation of Spirometry Guidelines. Statistical summaries were produced to compare the acceptability grade of FEV<sub>1</sub> and FVC at each session. McNemar tests were used to compare acceptability. <bold>Results:</bold> There were 166 sessions in total with clinic and off site spirometry readings, from 82 subjects. An FEV1 grade of A or B (as per ATS/ERS 2019 guidelines) was achieved in 161 sessions (97%) conducted on site and 156 (94%) conducted at home (p=0.32). An FVC grade of A or B was achieved in 152 sessions (91.5%) on site and 148 (89.1%) conducted at home (p=0.68). <bold>Discussion:</bold> The results from the BenRex cohort suggest that there is a high level of reproducibility of technical quality for remote spirometry [FEV<sub>1</sub> and FVC] conducted via video coaching. This has implications for study design and may support remote decentralised asthma trials in broader populations limited by geographical or time constraints.

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Published
2024-09-14
DOI
https://doi.org/10.1183/13993003.congress-2024.pa3985
Primary Topic
Asthma and respiratory diseases
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article
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article

Validation of Video Supported Spirometry in a Severe Asthma Patient Cohort from the BenRex Study

Thomas Brown, Ramesh Kurukulaaratchy, Salman Siddiqui, Liam Gabriel Heaney et al.
Asthma and respiratory diseases
article

Validation of Video Supported Spirometry in a Severe Asthma Patient Cohort from the BenRex Study

Thomas Brown, Ramesh Kurukulaaratchy, Salman Siddiqui, Liam Gabriel Heaney, Stephen James Fowler, Adel Mansur, Lynsey Gillespie, Wai-Ting Nicola Lee, Jim Lordan, Hassan Burhan, Christopher Edward Brightling, James O’Keeffe, Shoaib Faruqi, Holly Wilson, Grant Sowman, David J. Jackson, Dinesh Saralaya, Kirsty Wetherall, Rekha Chaudhuri, Alex McConnachie, Ian Pavord, James Brown, Pujan Patel, Jennifer Logan, J.I. Sáez de Ibarra, F. B. V. Keane
article en

Abstract

<bold>Background:</bold> The COVID-19 pandemic escalated the need for remote study procedures in clinical trials. Adaptations to the BenRex Study (Benralizumab Exacerbation Study) allowed for validation of video supported home spirometry against on site face-to-face sessions in severe asthma patients. <bold>Methods:</bold> At screening, participants received a Micro spirometer [Vitalograph, Buckingham, UK] and education on its use. A spirometry session was performed on site with face-to-face coaching from study staff, followed by a remote spirometry session within 24 hours, with coaching over video link at 3 visits. All Spirometry sessions had an over-read for quality assessment, by Respiratory Physiologists at Vitalograph, using the grading system per the ATS-ERS 2019 Standardisation of Spirometry Guidelines. Statistical summaries were produced to compare the acceptability grade of FEV<sub>1</sub> and FVC at each session. McNemar tests were used to compare acceptability. <bold>Results:</bold> There were 166 sessions in total with clinic and off site spirometry readings, from 82 subjects. An FEV1 grade of A or B (as per ATS/ERS 2019 guidelines) was achieved in 161 sessions (97%) conducted on site and 156 (94%) conducted at home (p=0.32). An FVC grade of A or B was achieved in 152 sessions (91.5%) on site and 148 (89.1%) conducted at home (p=0.68). <bold>Discussion:</bold> The results from the BenRex cohort suggest that there is a high level of reproducibility of technical quality for remote spirometry [FEV<sub>1</sub> and FVC] conducted via video coaching. This has implications for study design and may support remote decentralised asthma trials in broader populations limited by geographical or time constraints.

Queen's University Belfast (GB), University of Liverpool (GB), University of Leicester (GB), Royal Free London NHS Foundation Trust (GB), King's College London (GB), Hull Royal Infirmary (GB), Hammersmith Hospital (GB), Gartnavel General Hospital (GB), Royal Liverpool University Hospital (GB), Harefield Hospital (GB), Queen Alexandra Hospital (GB), University of Manchester (GB), University of Oxford (GB), Glasgow Life (GB), Royal Brompton Hospital (GB), Heartlands Hospital (GB), NIHR Royal Brompton Cardiovascular Biomedical Research Unit (GB), Calvary Mater Newcastle Hospital (AU), Southampton City Council (GB), King's College Hospital (GB), Glasgow Centre for Population Health (GB), Brooklands Hospital (GB), University of Southampton (GB), University of Glasgow (GB), National Patient Safety Foundation (US), University of Buckingham (GB)
Openalex Percentile: Top 72%
Asthma and respiratory diseases
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