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Article: Supportive care of patients with fibrosing interstitial lung disease: answering a great clinical need.

Goodwin, Amanda T / Saini, Gauri

2021 Volume 16, Issue 3, Page(s) 200066

Abstract: Fibrosing interstitial lung disease (F-ILD) significantly reduces quality of life. F-ILD care includes symptom management, end-of-life planning and supportive measures, as well as antifibrotics. Patients and carers should be central to all care decisions. ...

Abstract	Fibrosing interstitial lung disease (F-ILD) significantly reduces quality of life. F-ILD care includes symptom management, end-of-life planning and supportive measures, as well as antifibrotics. Patients and carers should be central to all care decisions.
Language	English
Publishing date	2021-01-14
Publishing country	England
Document type	Journal Article
ZDB-ID	2562899-9
ISSN	2073-4735 ; 1810-6838
ISSN (online)	2073-4735
ISSN	1810-6838
DOI	10.1183/20734735.0066-2020
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Article ; Online: Feasibility and acceptability of remotely monitoring spirometry and pulse oximetry as part of interstitial lung disease clinical care: a single arm observational study.

Barth, Sarah / Edwards, Colin / Saini, Gauri / Haider, Yussef / Williams, Nicholas Paul / Storrar, Will / Jenkins, Gisli / Stewart, Iain / Wickremasinghe, Melissa

Respiratory research

2024 Volume 25, Issue 1, Page(s) 162

Abstract: Background: Remote monitoring of patient-recorded spirometry and pulse oximetry offers an alternative approach to traditional hospital-based monitoring of interstitial lung disease (ILD). Remote spirometry has been observed to reasonably reflect clinic ... ...

Abstract	Background: Remote monitoring of patient-recorded spirometry and pulse oximetry offers an alternative approach to traditional hospital-based monitoring of interstitial lung disease (ILD). Remote spirometry has been observed to reasonably reflect clinic spirometry in participants with ILD but remote monitoring has not been widely incorporated into clinical practice. We assessed the feasibility of remotely monitoring patients within a clinical ILD service. Methods: Prospective, single-arm, open-label observational multi-centre study (NCT04850521). Inclusion criteria included ILD diagnosis, age ≥ 18 years, FVC ≥ 50% predicted. 60 participants were asked to record a single spirometry and oximetry measurement at least once daily, monitored weekly by their local clinical team. Feasibility was defined as ≥ 68% of participants with ≥ 70% adherence to study measurements and recording measurements ≥ 3 times/week throughout. Results: A total of 60 participants were included in the analysis. 42/60 (70%) were male; mean age 67.8 years (± 11.2); 34/60 (56.7%) had idiopathic pulmonary fibrosis (IPF), Median ILD-GAP score was 3 (IQR 1-4.75). Spirometry adherence was achieved for ≥ 70% of study days in 46/60 participants (77%) and pulse oximetry adherence in 50/60 participants (83%). Recording ≥ 3 times/week every week was provided for spirometry in 41/60 participants (68%) and pulse oximetry in 43/60 participants (72%). Mean difference between recent clinic and baseline home spirometry was 0.31 L (± 0.72). 85.7% (IQR 63.9-92.6%) home spirometry attempts/patient were acceptable or usable according to ERS/ATS spirometry criteria. Positive correlation was observed between ILD-GAP score and adherence to spirometry and oximetry (rho 0.24 and 0.38 respectively). Adherence of weekly monitoring by clinical teams was 80.95% (IQR 64.19-95.79). All participants who responded to an experience questionnaire (n = 33) found remote measurements easy to perform and 75% wished to continue monitoring their spirometry at the conclusion of the study. Conclusion: Feasibility of remote monitoring within an ILD clinical service was demonstrated over 3 months for both daily home spirometry and pulse oximetry of patients. Remote monitoring may be more acceptable to participants who are older or have more advanced disease. Trial registration: clinicaltrials.gov NCT04850521 registered 20
MeSH term(s)	Humans ; Male ; Aged ; Adolescent ; Female ; Prospective Studies ; Feasibility Studies ; Vital Capacity ; Lung Diseases, Interstitial/diagnosis ; Spirometry ; Oximetry
Language	English
Publishing date	2024-04-15
Publishing country	England
Document type	Observational Study ; Multicenter Study ; Journal Article
ZDB-ID	2041675-1
ISSN	1465-993X ; 1465-993X
ISSN (online)	1465-993X
ISSN	1465-993X
DOI	10.1186/s12931-024-02787-1
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Article ; Online: Deep Learning-based Segmentation of CT Scans Predicts Disease Progression and Mortality in IPF.

Thillai, Muhunthan / Oldham, Justin M / Ruggiero, Alessandro / Kanavati, Fahdi / McLellan, Tom / Saini, Gauri / Johnson, Simon R / Ble, Francois-Xavier / Azim, Adnan / Ostridge, Kristoffer / Platt, Adam / Belvisi, Maria / Maher, Toby M / Molyneaux, Philip L

American journal of respiratory and critical care medicine

2024

Abstract: Rationale: Despite evidence demonstrating a prognostic role for CT scans in IPF, image-based biomarkers are not routinely used in clinical practice or trials.: Objectives: Develop automated imaging biomarkers using deep learning based segmentation of ...

Abstract	Rationale: Despite evidence demonstrating a prognostic role for CT scans in IPF, image-based biomarkers are not routinely used in clinical practice or trials. Objectives: Develop automated imaging biomarkers using deep learning based segmentation of CT scans. Methods: We developed segmentation processes for four anatomical biomarkers which were applied to a unique cohort of treatment-naive IPF patients enrolled in the PROFILE study and tested against a further UK cohort. The relationship between CT biomarkers, lung function, disease progression and mortality were assessed. Measurements and main results: Data was analysed from 446 PROFILE patients. Median follow-up was 39.1 months (IQR 18.1-66.4) with cumulative incidence of death of 277 over 5 years (62.1%). Segmentation was successful on 97.8% of all scans, across multiple imaging vendors at slice thicknesses 0.5-5mm. Of 4 segmentations, lung volume showed strongest correlation with FVC (r=0.82, p<0.001). Lung, vascular and fibrosis volumes were consistently associated across cohorts with differential five-year survival, which persisted after adjustment for baseline GAP score. Lower lung volume (HR 0.98, CI 0.96-0.99, p=0.001), increased vascular volume (HR 1.30, CI 1.12-1.51, p=0.001) and increased fibrosis volume (HR 1.17, CI 1.12-1.22, p=<0.001) were associated with reduced two-year progression-free survival in the pooled PROFILE cohort. Longitudinally, decreasing lung volume (HR 3.41; 95% CI 1.36-8.54; p=0.009) and increasing fibrosis volume (HR 2.23; 95% CI 1.22-4.08; p=0.009) were associated with differential survival. Conclusions: Automated models can rapidly segment IPF CT scans, providing prognostic near and long-term information, which could be used in routine clinical practice or as key trial endpoints. This article is open access and distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
Language	English
Publishing date	2024-03-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	1180953-x
ISSN	1535-4970 ; 0003-0805 ; 1073-449X
ISSN (online)	1535-4970
ISSN	0003-0805 ; 1073-449X
DOI	10.1164/rccm.202311-2185OC
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Article ; Online: A systematic review of blood biomarkers with individual participant data meta-analysis of matrix metalloproteinase-7 in idiopathic pulmonary fibrosis.

Khan, Fasihul A / Stewart, Iain / Saini, Gauri / Robinson, Karen A / Jenkins, R Gisli

The European respiratory journal

2021 Volume 59, Issue 4

Abstract: Background: Blood-derived biomarkers have been described extensively as potential prognostic markers in idiopathic pulmonary fibrosis (IPF), but studies have been limited by analyses using data-dependent thresholds, inconsistent adjustment for ... ...

Abstract	Background: Blood-derived biomarkers have been described extensively as potential prognostic markers in idiopathic pulmonary fibrosis (IPF), but studies have been limited by analyses using data-dependent thresholds, inconsistent adjustment for confounders and an array of end-points, thus often yielding ungeneralisable results. Meta-analysis of individual participant data (IPD) is a powerful tool to overcome these limitations. Through systematic review of blood-derived biomarkers, sufficient studies with measurements of matrix metalloproteinase (MMP)-7 were identified to facilitate standardised analyses of the prognostic potential of this biomarker in IPF. Methods: Electronic databases were searched on 12 November 2020 to identify prospective studies reporting outcomes in patients with untreated IPF, stratified according to at least one pre-specified biomarker, measured at either baseline, or change over 3 months. IPD were sought for studies investigating MMP-7 as a prognostic factor. The primary outcome was overall mortality according to standardised MMP-7 z-scores, with a secondary outcome of disease progression in 12 months, all adjusted for age, gender, smoking and baseline forced vital capacity. Results: IPD was available for nine studies out of 12 identified, reporting outcomes from 1664 participants. Baseline MMP-7 levels were associated with increased mortality risk (adjusted hazard ratio 1.23, 95% CI 1.03-1.48; I Conclusion: IPD meta-analysis demonstrated that greater baseline MMP-7 levels were independently associated with an increased risk of poor outcomes in patients with untreated IPF, while short-term changes did not reflect disease progression.
MeSH term(s)	Biomarkers ; Disease Progression ; Humans ; Idiopathic Pulmonary Fibrosis ; Matrix Metalloproteinase 7/analysis ; Prospective Studies
Chemical Substances	Biomarkers ; MMP7 protein, human (EC 3.4.24.23) ; Matrix Metalloproteinase 7 (EC 3.4.24.23)
Language	English
Publishing date	2021-09-29
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Systematic Review
ZDB-ID	639359-7
ISSN	1399-3003 ; 0903-1936
ISSN (online)	1399-3003
ISSN	0903-1936
DOI	10.1183/13993003.01612-2021
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Article ; Online: Images of the month: The conundrum of chronic coccidioidomycosis.

Bolaji, Oluwabusola M / Zainudin, Nurul I / Snape, Susan / Saini, Gauri / Baskaran, Vadsala

Clinical medicine (London, England)

2021 Volume 21, Issue 1, Page(s) e110–e111

MeSH term(s)	Coccidioidomycosis/diagnostic imaging ; Humans
Language	English
Publishing date	2021-01-20
Publishing country	England
Document type	Journal Article
ZDB-ID	2048646-7
ISSN	1473-4893 ; 1470-2118
ISSN (online)	1473-4893
ISSN	1470-2118
DOI	10.7861/clinmed.2020-0815
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Article ; Online: The Burden and Impact of Cough in Patients with Idiopathic Pulmonary Fibrosis: An Analysis of the Prospective Observational PROFILE Study.

Saunders, Peter / Wu, Zhe / Fahy, William A / Stewart, Iain D / Saini, Gauri / Smith, David J F / Braybrooke, Rebecca / Stock, Carmel / Renzoni, Elisabetta A / Johnson, Simon R / Jenkins, R Gisli / Belvisi, Maria G / Smith, Jaclyn A / Maher, Toby M / Molyneaux, Philip L

Annals of the American Thoracic Society

2023 Volume 20, Issue 9, Page(s) 1267–1273

Abstract: Rationale: ...

Abstract	Rationale:
MeSH term(s)	Humans ; Cough/epidemiology ; Cough/etiology ; Cough/diagnosis ; Quality of Life ; Longitudinal Studies ; Prospective Studies ; Idiopathic Pulmonary Fibrosis/complications ; Surveys and Questionnaires
Language	English
Publishing date	2023-03-27
Publishing country	United States
Document type	Observational Study ; Multicenter Study ; Journal Article
ZDB-ID	2717461-X
ISSN	2325-6621 ; 1943-5665 ; 2325-6621
ISSN (online)	2325-6621 ; 1943-5665
ISSN	2325-6621
DOI	10.1513/AnnalsATS.202302-174OC
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Article ; Online: CYFRA 21-1 Predicts Progression in Idiopathic Pulmonary Fibrosis: A Prospective Longitudinal Analysis of the PROFILE Cohort.

Molyneaux, Philip L / Fahy, William A / Byrne, Adam J / Braybrooke, Rebecca / Saunders, Peter / Toshner, Richard / Albers, Gesa / Chua, Felix / Renzoni, Elisabetta A / Wells, Athol U / Karkera, Yakshitha / Oballa, Eunice / Saini, Gauri / Nicholson, Andrew G / Jenkins, R Gisli / Maher, Toby M

American journal of respiratory and critical care medicine

2022 Volume 205, Issue 12, Page(s) 1440–1448

Abstract: Rationale: ...

Abstract	Rationale:
MeSH term(s)	Antigens, Neoplasm ; Biomarkers ; Disease Progression ; Humans ; Idiopathic Pulmonary Fibrosis ; Keratin-19 ; Prospective Studies
Chemical Substances	Antigens, Neoplasm ; Biomarkers ; Keratin-19 ; antigen CYFRA21.1
Language	English
Publishing date	2022-04-01
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1180953-x
ISSN	1535-4970 ; 0003-0805 ; 1073-449X
ISSN (online)	1535-4970
ISSN	0003-0805 ; 1073-449X
DOI	10.1164/rccm.202107-1769OC
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Article ; Online: Clinical Utility of Home versus Hospital Spirometry in Fibrotic Interstitial Lung Disease: Evaluation after INJUSTIS Interim Analysis.

Khan, Fasihul / Howard, Lucy / Hearson, Glenn / Edwards, Colin / Barber, Chris / Jones, Steve / Wilson, Andrew M / Maher, Toby M / Saini, Gauri / Stewart, Iain / Jenkins, Gisli

Annals of the American Thoracic Society

2021 Volume 19, Issue 3, Page(s) 506–509

MeSH term(s)	Hospitals ; Humans ; Lung ; Lung Diseases, Interstitial/diagnosis ; Spirometry
Language	English
Publishing date	2021-09-17
Publishing country	United States
Document type	Letter
ZDB-ID	2717461-X
ISSN	2325-6621 ; 1943-5665 ; 2325-6621
ISSN (online)	2325-6621 ; 1943-5665
ISSN	2325-6621
DOI	10.1513/AnnalsATS.202105-612RL
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Article ; Online: Forced vital capacity trajectories in patients with idiopathic pulmonary fibrosis: a secondary analysis of a multicentre, prospective, observational cohort.

The Lancet. Digital health

2022 Volume 4, Issue 12, Page(s) e862–e872

Abstract: Background: Idiopathic pulmonary fibrosis is a progressive fibrotic lung disease with a variable clinical trajectory. Decline in forced vital capacity (FVC) is the main indicator of progression; however, missingness prevents long-term analysis of ... ...

Abstract	Background: Idiopathic pulmonary fibrosis is a progressive fibrotic lung disease with a variable clinical trajectory. Decline in forced vital capacity (FVC) is the main indicator of progression; however, missingness prevents long-term analysis of patterns in lung function. We aimed to identify distinct clusters of lung function trajectory among patients with idiopathic pulmonary fibrosis using machine learning techniques. Methods: We did a secondary analysis of longitudinal data on FVC collected from a cohort of patients with idiopathic pulmonary fibrosis from the PROFILE study; a multicentre, prospective, observational cohort study. We evaluated the imputation performance of conventional and machine learning techniques to impute missing data and then analysed the fully imputed dataset by unsupervised clustering using self-organising maps. We compared anthropometric features, genomic associations, serum biomarkers, and clinical outcomes between clusters. We also performed a replication of the analysis on data from a cohort of patients with idiopathic pulmonary fibrosis from an independent dataset, obtained from the Chicago Consortium. Findings: 415 (71%) of 581 participants recruited into the PROFILE study were eligible for further analysis. An unsupervised machine learning algorithm had the lowest imputation error among tested methods, and self-organising maps identified four distinct clusters (1-4), which was confirmed by sensitivity analysis. Cluster 1 comprised 140 (34%) participants and was associated with a disease trajectory showing a linear decline in FVC over 3 years. Cluster 2 comprised 100 (24%) participants and was associated with a trajectory showing an initial improvement in FVC before subsequently decreasing. Cluster 3 comprised 113 (27%) participants and was associated with a trajectory showing an initial decline in FVC before subsequent stabilisation. Cluster 4 comprised 62 (15%) participants and was associated with a trajectory showing stable lung function. Median survival was shortest in cluster 1 (2·87 years [IQR 2·29-3·40]) and cluster 3 (2·23 years [1·75-3·84]), followed by cluster 2 (4·74 years [3·96-5·73]), and was longest in cluster 4 (5·56 years [5·18-6·62]). Baseline FEV Interpretation: Using a data-driven unsupervised approach, we identified four clusters of lung function trajectory with distinct clinical and biochemical features. Enriching or stratifying longitudinal spirometric data into clusters might optimise evaluation of intervention efficacy during clinical trials and patient management. Funding: National Institute for Health and Care Research, Medical Research Council, and GlaxoSmithKline.
MeSH term(s)	Humans ; Idiopathic Pulmonary Fibrosis/drug therapy ; Idiopathic Pulmonary Fibrosis/genetics ; Prospective Studies ; Vital Capacity ; Cohort Studies ; Biomarkers
Chemical Substances	Biomarkers
Language	English
Publishing date	2022-11-01
Publishing country	England
Document type	Observational Study ; Multicenter Study ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	2589-7500
ISSN (online)	2589-7500
DOI	10.1016/S2589-7500(22)00173-X
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Article ; Online: A lung targeted miR-29 mimic as a therapy for pulmonary fibrosis.

EBioMedicine

2022 Volume 85, Page(s) 104304

Abstract: Background: MicroRNAs are non-coding RNAs that negatively regulate gene networks. Previously, we reported that systemically delivered miR-29 mimic MRG-201 reduced fibrosis in animal models, supporting the consideration of miR-29-based therapies for ... ...

Abstract	Background: MicroRNAs are non-coding RNAs that negatively regulate gene networks. Previously, we reported that systemically delivered miR-29 mimic MRG-201 reduced fibrosis in animal models, supporting the consideration of miR-29-based therapies for idiopathic pulmonary fibrosis (IPF). Methods: We generated MRG-229, a next-generation miR-29 mimic based on MRG-201 with improved chemical stability due to additional sugar modifications and conjugation with the internalization moiety BiPPB (PDGFbetaR-specific bicyclic peptide) Findings: The peptide-conjugated MRG-229 mimic decreased expression of pro-fibrotic genes and reduced collagen production in each model. In bleomycin-treated mice, the peptide-conjugated MRG-229 mimic downregulated profibrotic gene programs at doses more than ten-fold lower than the original compound. In rats and non-human primates, the peptide-conjugated MRG-229 mimic was well tolerated at clinically relevant doses with no adverse findings observed. In human peripheral blood from IPF patients decreased miR-29 concentrations were associated with increased mortality in two cohorts potentially identified as a target population for treatment. Interpretation: Collectively, our results provide support for the development of the peptide-conjugated MRG-229 mimic as a potential therapy in humans with IPF. Funding: This work was supported by NIH NHLBI grants UH3HL123886, R01HL127349, R01HL141852, U01HL145567.
MeSH term(s)	Humans ; Mice ; Rats ; Animals ; Lung/metabolism ; Idiopathic Pulmonary Fibrosis/diagnosis ; Idiopathic Pulmonary Fibrosis/genetics ; Idiopathic Pulmonary Fibrosis/therapy ; Bleomycin ; MicroRNAs/genetics ; MicroRNAs/metabolism ; Fibroblasts/metabolism
Chemical Substances	Bleomycin (11056-06-7) ; MicroRNAs ; MIRN29 microRNA, mouse ; MIRN29 microRNA, rat
Language	English
Publishing date	2022-10-17
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2851331-9
ISSN	2352-3964
ISSN (online)	2352-3964
DOI	10.1016/j.ebiom.2022.104304
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