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Exogenous sex steroid hormones and asthma phenotypes: a study protocol for a prospective cohort analysis with UK-wide
Fatima Almaghrabi1, Bright I Nwaru2, Aziz Sheikh3
1Usher Institute, The University of Edinburgh, Edinburgh, UK.
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.
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