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Androgens In Men Study (AIMS): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men.
- Source :
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BMJ open [BMJ Open] 2020 May 11; Vol. 10 (5), pp. e034777. Date of Electronic Publication: 2020 May 11. - Publication Year :
- 2020
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Abstract
- Introduction: This study aims to clarify the role(s) of endogenous sex hormones to influence health outcomes in men, specifically to define the associations of plasma testosterone with incidence of cardiovascular events, cancer, dementia and mortality risk, and to identify factors predicting testosterone concentrations. Data will be accrued from at least three Australian, two European and four North American population-based cohorts involving approximately 20 000 men.<br />Methods and Analysis: Eligible studies include prospective cohort studies with baseline testosterone concentrations measured using mass spectrometry and 5 years of follow-up data on incident cardiovascular events, mortality, cancer diagnoses or deaths, new-onset dementia or decline in cognitive function recorded. Data for men, who were not taking androgens or drugs suppressing testosterone production, metabolism or action; and had no prior orchidectomy, are eligible. Systematic literature searches were conducted from 14 June 2019 to 31 December 2019, with no date range set for searches. Aggregate level data will be sought where individual participant data (IPD) are not available. One-stage IPD random-effects meta-analyses will be performed, using linear mixed models, generalised linear mixed models and either stratified or frailty-augmented Cox regression models. Heterogeneity in estimates from different studies will be quantified and bias investigated using funnel plots. Effect size estimates will be presented in forest plots and non-negligible heterogeneity and bias investigated using subgroup or meta-regression analyses.<br />Ethics and Dissemination: Ethics approvals obtained for each of the participating cohorts state that participants have consented to have their data collected and used for research purposes. The Androgens In Men Study has been assessed as exempt from ethics review by the Human Ethics office at the University of Western Australia (file reference number RA/4/20/5014). Each of the component studies had obtained ethics approvals; please refer to respective component studies for details. Research findings will be disseminated to the scientific and broader community via the publication of four research articles, with each involving a separate set of IPD meta-analyses (articles will investigate different, distinct outcomes), at scientific conferences and meetings of relevant professional societies. Collaborating cohort studies will disseminate findings to study participants and local communities.<br />Prospero Registration Number: CRD42019139668.<br />Competing Interests: Competing interests: None declared.<br /> (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)
- Subjects :
- Adult
Humans
Male
Androgens deficiency
Cause of Death
Cohort Studies
Dihydrotestosterone blood
Estradiol blood
Incidence
Logistic Models
Mass Spectrometry
Men's Health
Prospective Studies
Meta-Analysis as Topic
Cardiovascular Diseases epidemiology
Cardiovascular Diseases mortality
Dementia epidemiology
Dementia mortality
Neoplasms epidemiology
Neoplasms mortality
Testosterone blood
Subjects
Details
- Language :
- English
- ISSN :
- 2044-6055
- Volume :
- 10
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- BMJ open
- Publication Type :
- Academic Journal
- Accession number :
- 32398333
- Full Text :
- https://doi.org/10.1136/bmjopen-2019-034777