Isabella Montagna’s research while affiliated with Chiesi Farmaceutici S.p.A. and other places

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Publications (28)


Is Onsite Spirometry Quality Predicting the Quality of Home Spirometry?
  • Conference Paper

April 2024

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1 Read

B. Cuyvers

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P. Desbordes

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Performance evaluation of baseline ArtiQ.QC using original over reader labels as the comparator in the 20% test data set.
Performance evaluation of recalibrated ArtiQ.QC using original over reader labels as the comparator in the 20% test data set.
AI-based software facilitates spirometry quality control in asthma and COPD clinical trials
  • Article
  • Full-text available

November 2022

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111 Reads

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12 Citations

ERJ Open Research

Rationale Acquiring high-quality spirometry data in clinical trials is important, particularly when using FEV1 or FVC as primary endpoints. In addition to quantitative criteria, the ATS/ERS standards include subjective evaluation which introduces inter-rater variability and potential mistakes. We explored the value of AI-based software (ArtiQ.QC) to assess spirometry quality and compared it to traditional over-reading control. Methods A random sample of 2000 sessions (8258 curves) was selected from Chiesi COPD and Asthma trials (N=1000 per disease). Acceptability using the 2005 ATS/ERS standards was determined by over-reader review and by ArtiQ.QC. Additionally, three respiratory physicians jointly reviewed a subset of curves (N=150). Results The majority of curves (N=7267, 88%) were of good quality. The AI agreed with over-readers in 91% of cases, with 97% sensitivity and 93% positive predictive value. Performance was significantly better in the asthma group. In the revised subset, N=50 curves were repeated to assess intra-rater reliability, (Kappa: 0.83, 0.86 and 0.80). All reviewers agreed on 63% of 100 unique tests (Kappa=0.5). When reviewers set the consensus (gold-standard), individual agreement with it was 88%, 94% and 70%. The agreement between AI and “gold-standard” was 73%, over reader agreement was 46%. Conclusion AI-based software can be used to measure spirometry data quality with comparable accuracy as experts. The assessment is a subjective exercise, with intra- and inter-rater variability even when the criteria are defined very precisely and objectively. By providing consistent results and immediate feedback to the sites, AI may benefit clinical trial conduct and variability reduction.

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Citations (12)


... The model was trained based on spirometry measurements from the National Health and Nutritional Examination Survey (NHANES 2011-2012) 12 and validated in clinical trial settings. 14 The spirometry interpretation component is a decision support software focusing on the diagnostic interpretation of spirometry sessions. It provides support in pattern interpretation according to international interpretation guidelines (ie, normal, obstructive and/or restrictive) 15 and a disease probability. ...

Reference:

Comparing performance of primary care clinicians in the interpretation of SPIROmetry with or without Artificial Intelligence Decision support software (SPIRO-AID): a protocol for a randomised controlled trial
AI Over-reading Based on ATS/ERS 2019 Criteria Is a Reliable Option for Instant Spirometry Quality Control in Clinical Trials
  • Citing Conference Paper
  • May 2023

... Accuracy was highest in asthma (90%, specificity 84%) and lowest in COPD (43%) due to low specificity (52%) and PPV (25%). 19 Robertson et al. reported collaboration between pulmonologists and explainable AI improves interpretation accuracy, requiring appropriate training and oversight 20 Our study confirms that ChatGPT spirometry interpretation aligns closely with respiratory physician assessments, particularly for normal, restrictive, and mixed patterns. Discrepancies in the classification of spirometry, AI demonstrated high diagnostic accuracy and consistency. ...

AI-based software facilitates spirometry quality control in asthma and COPD clinical trials

ERJ Open Research

... The Artiq.QC software evaluates the quality of the data by checking the numerical quality criteria, as well as the visual shape of the curve with its deep-learning artificial intelligence. 26 Doing so mimics the human visual evaluation of the curve, typically done by human over-readers. It can detect artefacts defined by the ATS/ERS standards and evaluate the impact of these artefacts on the acceptability and/or usability of the data. ...

ArtiQ.QC facilitates spirometry quality control in asthma and COPD clinical trials
  • Citing Conference Paper
  • September 2021

... Recently, it has been demonstrated in a retrospective study that machine learning software may be helpful in clinical trials to ensure the quality consistency of spirometry evaluation promptly in comparison to human over-readers [13]. In a very recent study [14], spirometry PDF files collected during hospital examinations A c c e p t e d M a n u s c r i p t were labeled according to ATS/ERS 2019 criteria, and a deep learning model was constructed to determine acceptability, usability, and quality rating for FEV1 and FVC. ...

Artificial Intelligence Assists in Quality Assessment of Spirometry in Clinical Trials

... p = 0.037). 103,104 In conclusion, a fixed combination of three drugs in a single inhaler can improve long-term adherence to the therapy, reducing the risk of exacerbations and hospital resources utilization. The twice a day administration may provide a better coverage at night, particularly in highly symptomatic COPD patients. ...

Reduction in fatal events with extrafine inhaled corticosteroid (ICS)-containing medications: Results of stratified safety pooled analysis of the TRILOGY, TRINITY and TRIBUTE studies
  • Citing Conference Paper
  • March 2019

Pneumologie

... 2,16,17 Despite these available therapeutic options, and challenges association with smoking cessation, it is estimated that 30% to 60% of patients continue to experience moderate to severe exacerbations while receiving dual or triple inhaled therapy, highlighting an unmet medical need for more effective treatment options for the management of COPD exacerbations. [18][19][20][21][22][23] Several monoclonal antibodies targeting different inflammatory pathways are currently under development, and one has been recently approved, aimed at decreasing exacerbation risk and improving symptoms in people with COPD who continue to experience exacerbations while on inhaled dual or triple therapy. [24][25][26][27] However, the patients enrolled in clinical trials may differ from the heterogenous real-world population 28 and little is known about the characteristics and clinical outcomes of this COPD population in routine clinical practice. ...

Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): A double-blind, parallel group, randomised controlled trial
  • Citing Article
  • February 2018

The Lancet

... Studies have specifically examined the cardiovascular safety profile of fixed-dose combinations incorporating glycopyrronium and formoterol delivered via inhalers. These investigations have indicated that GFF therapy, administered through a metered dose inhaler utilizing Co-Suspension™ delivery technology, exhibits a favorable cardiovascular safety profile [27,28]. Additionally, the cardiovascular safety profiles of alternative combination therapies, such as QVA149 and budesonide/glycopyrrolate/formoterol fumarate, have also been evaluated, underscoring the importance of assessing cardiovascular effects when considering treatment options for respiratory conditions [29,30]. ...

P276 Cardiovascular safety of extrafine single inhaler triple combination of beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide in copd: results of safety analysis from the trilogy and trinity studies
  • Citing Conference Paper
  • December 2017

Thorax

... From these, we identified 105 as potentially relevant. A full-text analysis led to the removal of 90, leaving 15 records (seven abstracts/posters) belonging to six studies for inclusion ( Fig. 1) [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30]. Detailed reasons for exclusion are outlined in Additional file 1: Table S3. ...

P273 Association of incident pneumonia and exacerbations with extrafine triple therapy in one single inhaler in copd patients: a post-hoc analysis from trilogy and trinity studies
  • Citing Conference Paper
  • December 2017

Thorax

... ICSs/LAMAs/LABAs had significant benefits for the reduction of acute exacerbations [9,[12][13][14][15], symptoms [15,16], and rescue medication use [17], and the improvement of lung function [13,15,16] compared with ICSs/ LABAs or LAMAs/LABAs in randomized controlled trials (RCTs). Furthermore, we previously showed that triple therapy reduced all-cause mortality compared with other dual or single treatments [18]. ...

P271 Effect of extrafine single inhaler triple therapy on lung function and use of rescue medication: results from the trinity study
  • Citing Conference Paper
  • December 2017

Thorax

... 2,16,17 Despite these available therapeutic options, and challenges association with smoking cessation, it is estimated that 30% to 60% of patients continue to experience moderate to severe exacerbations while receiving dual or triple inhaled therapy, highlighting an unmet medical need for more effective treatment options for the management of COPD exacerbations. [18][19][20][21][22][23] Several monoclonal antibodies targeting different inflammatory pathways are currently under development, and one has been recently approved, aimed at decreasing exacerbation risk and improving symptoms in people with COPD who continue to experience exacerbations while on inhaled dual or triple therapy. [24][25][26][27] However, the patients enrolled in clinical trials may differ from the heterogenous real-world population 28 and little is known about the characteristics and clinical outcomes of this COPD population in routine clinical practice. ...

Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): A double-blind, parallel group, randomised controlled trial
  • Citing Article
  • April 2017

The Lancet