Exogenous sex steroid hormones and asthma phenotypes: a study protocol for a prospective cohort analysis with UK-wide primary care data
Introduction The role of female sex hormones and their influence on asthma’s development and natural history remain uncertain. Our study aims to enhance understanding of exogenous sex hormones’ role in asthma development and manifestation, considering phenotypic heterogeneity and focusing on metabol...
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BMJ Publishing Group
2025-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/3/e097126.full |
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| author | Aziz Sheikh Holly Tibble Athanasios Tsanas Bright I Nwaru Azhar Ali Syed Ahmar Shah Hilary Critchley Tracy Jackson Fatima Almaghrabi |
| author_facet | Aziz Sheikh Holly Tibble Athanasios Tsanas Bright I Nwaru Azhar Ali Syed Ahmar Shah Hilary Critchley Tracy Jackson Fatima Almaghrabi |
| author_sort | Aziz Sheikh |
| collection | DOAJ |
| description | Introduction The role of female sex hormones and their influence on asthma’s development and natural history remain uncertain. Our study aims to enhance understanding of exogenous sex hormones’ role in asthma development and manifestation, considering phenotypic heterogeneity and focusing on metabolic syndrome-linked asthma that has shown increased severity in females.Methods and analysis A cohort study using primary care data from the Clinical Practice Research Datalink (CPRD) databases linked with additional data sources (Hospital Episode Statistics, ethnicity and deprivation) will include individuals aged 16–70 years, spanning 1 January 2005 to 31 December 2019. We will use appropriate statistical learning methods depending on the outcome: extended Cox regression for late-onset asthma; Poisson or negative binomial regression for asthma exacerbations; binary logistic regression for asthma control; and ordered logistic regression for asthma severity. Asthma exacerbation will be defined based on the American Thoracic Society/European Respiratory Society Task Force definition as the presence of either one of an asthma-related accident and emergency department visit, an asthma-related (unscheduled) hospital admission or an acute course of oral corticosteroids (OCS) with evidence of asthma-related medical event and/or review within 2 weeks of OCS prescription. Poor asthma control in any given month will be defined by the occurrence of an exacerbation episode or use of short-acting beta agonist. Asthma severity will be defined based on the British Thoracic Society asthma severity steps. Asthma phenotypes will be identified using k-means clustering. Analyses will be undertaken using both GOLD and Aurum to ensure coverage across UK nations.Ethics and dissemination CPRD has received ethics approval from the Health Research Authority (East Midlands—Derby, REC reference number 21/EM/065) to support research using anonymised data. Approval to conduct this study was obtained through CPRD’s Research Data Governance process. The results will be disseminated through academic publications and conference presentations, contributing to the understanding and practice of asthma management, particularly in the context of the impacts of exogenous sex steroid hormones. |
| format | Article |
| id | doaj-art-1c148fdf587b4b8181b93ec74867e34b |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-1c148fdf587b4b8181b93ec74867e34b2025-08-20T02:41:43ZengBMJ Publishing GroupBMJ Open2044-60552025-03-0115310.1136/bmjopen-2024-097126Exogenous sex steroid hormones and asthma phenotypes: a study protocol for a prospective cohort analysis with UK-wide primary care dataAziz Sheikh0Holly Tibble1Athanasios Tsanas2Bright I Nwaru3Azhar Ali4Syed Ahmar Shah5Hilary Critchley6Tracy Jackson7Fatima Almaghrabi85Usher Institute, University of EdinburghAsthma UK Centre for Applied Research, Edinburgh, UKUsher Institute, Edinburgh Medical School, University of Edinburgh, Edinburgh, UKWallenberg Centre for Molecular and Translational Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden5 Institute for Healthcare Improvement, Cambridge, Massachusetts, USAThe University of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, UKObstetrics and Gynaecology, The University of Edinburgh, Edinburgh, UK1Midlands Endoscopy Training Academy, Birmingham, UKUsher Institute, The University of Edinburgh, Edinburgh, UKIntroduction The role of female sex hormones and their influence on asthma’s development and natural history remain uncertain. Our study aims to enhance understanding of exogenous sex hormones’ role in asthma development and manifestation, considering phenotypic heterogeneity and focusing on metabolic syndrome-linked asthma that has shown increased severity in females.Methods and analysis A cohort study using primary care data from the Clinical Practice Research Datalink (CPRD) databases linked with additional data sources (Hospital Episode Statistics, ethnicity and deprivation) will include individuals aged 16–70 years, spanning 1 January 2005 to 31 December 2019. We will use appropriate statistical learning methods depending on the outcome: extended Cox regression for late-onset asthma; Poisson or negative binomial regression for asthma exacerbations; binary logistic regression for asthma control; and ordered logistic regression for asthma severity. Asthma exacerbation will be defined based on the American Thoracic Society/European Respiratory Society Task Force definition as the presence of either one of an asthma-related accident and emergency department visit, an asthma-related (unscheduled) hospital admission or an acute course of oral corticosteroids (OCS) with evidence of asthma-related medical event and/or review within 2 weeks of OCS prescription. Poor asthma control in any given month will be defined by the occurrence of an exacerbation episode or use of short-acting beta agonist. Asthma severity will be defined based on the British Thoracic Society asthma severity steps. Asthma phenotypes will be identified using k-means clustering. Analyses will be undertaken using both GOLD and Aurum to ensure coverage across UK nations.Ethics and dissemination CPRD has received ethics approval from the Health Research Authority (East Midlands—Derby, REC reference number 21/EM/065) to support research using anonymised data. Approval to conduct this study was obtained through CPRD’s Research Data Governance process. The results will be disseminated through academic publications and conference presentations, contributing to the understanding and practice of asthma management, particularly in the context of the impacts of exogenous sex steroid hormones.https://bmjopen.bmj.com/content/15/3/e097126.full |
| spellingShingle | Aziz Sheikh Holly Tibble Athanasios Tsanas Bright I Nwaru Azhar Ali Syed Ahmar Shah Hilary Critchley Tracy Jackson Fatima Almaghrabi Exogenous sex steroid hormones and asthma phenotypes: a study protocol for a prospective cohort analysis with UK-wide primary care data BMJ Open |
| title | Exogenous sex steroid hormones and asthma phenotypes: a study protocol for a prospective cohort analysis with UK-wide primary care data |
| title_full | Exogenous sex steroid hormones and asthma phenotypes: a study protocol for a prospective cohort analysis with UK-wide primary care data |
| title_fullStr | Exogenous sex steroid hormones and asthma phenotypes: a study protocol for a prospective cohort analysis with UK-wide primary care data |
| title_full_unstemmed | Exogenous sex steroid hormones and asthma phenotypes: a study protocol for a prospective cohort analysis with UK-wide primary care data |
| title_short | Exogenous sex steroid hormones and asthma phenotypes: a study protocol for a prospective cohort analysis with UK-wide primary care data |
| title_sort | exogenous sex steroid hormones and asthma phenotypes a study protocol for a prospective cohort analysis with uk wide primary care data |
| url | https://bmjopen.bmj.com/content/15/3/e097126.full |
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