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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
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 testost...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7239545/ https://www.ncbi.nlm.nih.gov/pubmed/32398333 http://dx.doi.org/10.1136/bmjopen-2019-034777 |
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author | Yeap, Bu Beng Marriott, Ross James Adams, Robert J Antonio, Leen Ballantyne, Christie M Bhasin, Shalender Cawthon, Peggy M Couper, David John Dobs, Adrian S Flicker, Leon Karlsson, Magnus Martin, Sean A Matsumoto, Alvin M Mellström, Dan Norman, Paul E Ohlsson, Claes Orwoll, Eric S O'Neill, Terence W Shores, Molly M Travison, Thomas G Vanderschueren, Dirk Wittert, Gary A Wu, Frederick C W Murray, Kevin |
author_facet | Yeap, Bu Beng Marriott, Ross James Adams, Robert J Antonio, Leen Ballantyne, Christie M Bhasin, Shalender Cawthon, Peggy M Couper, David John Dobs, Adrian S Flicker, Leon Karlsson, Magnus Martin, Sean A Matsumoto, Alvin M Mellström, Dan Norman, Paul E Ohlsson, Claes Orwoll, Eric S O'Neill, Terence W Shores, Molly M Travison, Thomas G Vanderschueren, Dirk Wittert, Gary A Wu, Frederick C W Murray, Kevin |
author_sort | Yeap, Bu Beng |
collection | PubMed |
description | 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. 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. 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. PROSPERO REGISTRATION NUMBER: CRD42019139668. |
format | Online Article Text |
id | pubmed-7239545 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-72395452020-05-28 Androgens In Men Study (AIMS): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men Yeap, Bu Beng Marriott, Ross James Adams, Robert J Antonio, Leen Ballantyne, Christie M Bhasin, Shalender Cawthon, Peggy M Couper, David John Dobs, Adrian S Flicker, Leon Karlsson, Magnus Martin, Sean A Matsumoto, Alvin M Mellström, Dan Norman, Paul E Ohlsson, Claes Orwoll, Eric S O'Neill, Terence W Shores, Molly M Travison, Thomas G Vanderschueren, Dirk Wittert, Gary A Wu, Frederick C W Murray, Kevin BMJ Open Diabetes and Endocrinology 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. 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. 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. PROSPERO REGISTRATION NUMBER: CRD42019139668. BMJ Publishing Group 2020-05-11 /pmc/articles/PMC7239545/ /pubmed/32398333 http://dx.doi.org/10.1136/bmjopen-2019-034777 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Diabetes and Endocrinology Yeap, Bu Beng Marriott, Ross James Adams, Robert J Antonio, Leen Ballantyne, Christie M Bhasin, Shalender Cawthon, Peggy M Couper, David John Dobs, Adrian S Flicker, Leon Karlsson, Magnus Martin, Sean A Matsumoto, Alvin M Mellström, Dan Norman, Paul E Ohlsson, Claes Orwoll, Eric S O'Neill, Terence W Shores, Molly M Travison, Thomas G Vanderschueren, Dirk Wittert, Gary A Wu, Frederick C W Murray, Kevin Androgens In Men Study (AIMS): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men |
title | Androgens In Men Study (AIMS): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men |
title_full | Androgens In Men Study (AIMS): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men |
title_fullStr | Androgens In Men Study (AIMS): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men |
title_full_unstemmed | Androgens In Men Study (AIMS): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men |
title_short | Androgens In Men Study (AIMS): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men |
title_sort | androgens in men study (aims): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men |
topic | Diabetes and Endocrinology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7239545/ https://www.ncbi.nlm.nih.gov/pubmed/32398333 http://dx.doi.org/10.1136/bmjopen-2019-034777 |
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