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 testoste...
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BMJ Publishing Group
2020-05-01
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Series: | BMJ Open |
Online Access: | https://bmjopen.bmj.com/content/10/5/e034777.full |
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Article |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Alvin M Matsumoto Leon Flicker Kevin Murray Robert J Adams Magnus Karlsson Bu Beng Yeap Ross James Marriott Leen Antonio Christie M Ballantyne Shalender Bhasin Peggy M Cawthon David John Couper Adrian S Dobs Sean A Martin Dan Mellström Paul E Norman Claes Ohlsson Eric S Orwoll Terence W O'Neill Molly M Shores Thomas G Travison Dirk Vanderschueren Gary A Wittert Frederick C W Wu |
spellingShingle |
Alvin M Matsumoto Leon Flicker Kevin Murray Robert J Adams Magnus Karlsson Bu Beng Yeap Ross James Marriott Leen Antonio Christie M Ballantyne Shalender Bhasin Peggy M Cawthon David John Couper Adrian S Dobs Sean A Martin Dan Mellström Paul E Norman Claes Ohlsson Eric S Orwoll Terence W O'Neill Molly M Shores Thomas G Travison Dirk Vanderschueren Gary A Wittert Frederick C W Wu Androgens In Men Study (AIMS): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men BMJ Open |
author_facet |
Alvin M Matsumoto Leon Flicker Kevin Murray Robert J Adams Magnus Karlsson Bu Beng Yeap Ross James Marriott Leen Antonio Christie M Ballantyne Shalender Bhasin Peggy M Cawthon David John Couper Adrian S Dobs Sean A Martin Dan Mellström Paul E Norman Claes Ohlsson Eric S Orwoll Terence W O'Neill Molly M Shores Thomas G Travison Dirk Vanderschueren Gary A Wittert Frederick C W Wu |
author_sort |
Alvin M Matsumoto |
title |
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_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_sort |
androgens in men study (aims): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men |
publisher |
BMJ Publishing Group |
series |
BMJ Open |
issn |
2044-6055 |
publishDate |
2020-05-01 |
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. |
url |
https://bmjopen.bmj.com/content/10/5/e034777.full |
work_keys_str_mv |
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doaj-946e5b4343624bf48139c7ae6a59d2602020-11-25T03:06:12ZengBMJ Publishing GroupBMJ Open2044-60552020-05-0110510.1136/bmjopen-2019-034777Androgens In Men Study (AIMS): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in menAlvin M MatsumotoLeon Flicker0Kevin MurrayRobert J AdamsMagnus Karlsson1Bu Beng Yeap2Ross James Marriott3Leen Antonio4Christie M Ballantyne5Shalender Bhasin6Peggy M Cawthon7David John Couper8Adrian S Dobs9Sean A Martin10Dan Mellström11Paul E Norman12Claes Ohlsson13Eric S Orwoll14Terence W O'Neill15Molly M Shores16Thomas G Travison17Dirk Vanderschueren18Gary A Wittert19Frederick C W Wu20WA Centre for Health & Ageing, Medical School, University of Western Australia, Perth, Western Australia, AustraliaClinical and Molecular Osteoporosis Research Unit, Department of Clinical Sciences, Lund University, Malmö, SwedenMedical School, University of Western Australia, Perth, Western Australia, AustraliaSchool of Population and Global Health, University of Western Australia, Perth, Western Australia, AustraliaClinical and Experimental Endocrinology, KU Leuven, Leuven, BelgiumInternal Medicine, Baylor College of Medicine, Houston, Texas, USAHarvard Medical School, Boston, Massachusetts, USASan Francisco Coordinating Center, California Pacific Medical Center Research Institute, San Francisco, California, USAGillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USASchool of Medicine, Division of Endocrinology, Diabetes and Metabolism, Johns Hopkins University, Baltimore, Maryland, USAFreemasons Foundation Centre for Men's Health, The University of Adelaide, Adelaide, South Australia, AustraliaCentre for Bone and Arthritis Research at the Sahlgrenska Academy, Institute of Medicine, University of Gothenburg, Goteborg, SwedenMedical School, University of Western Australia, Perth, Western Australia, AustraliaCentre for Bone and Arthritis Research at the Sahlgrenska Academy, Institute of Medicine, University of Gothenburg, Goteborg, SwedenOregon Health & Science University, Portland, Oregon, USACentre for Epidemiology Versus Arthritis, Faculty of Biology, Medicine and Health, The University of Manchester & NIHR Manchester Biomedical Research Centre, Manchester, UKVA Puget Sound Health Care System, Seattle, Washington, USAHarvard Medical School, Boston, Massachusetts, USADepartment of Chronic Diseases, Metabolism and Ageing (CHROMETA), Laboratory of Clinical and Experimental Endocrinology, Katholieke Universiteit Leuven, Leuven, Flanders, BelgiumFreemasons Foundation Centre for Men's Health, The University of Adelaide, Adelaide, South Australia, AustraliaDivision of Diabetes, Endocrinology and Gastroenterology, The University of Manchester, Manchester, UKIntroduction 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.https://bmjopen.bmj.com/content/10/5/e034777.full |