TY - JOUR
T1 - Androgens in men study (AIMS)
T2 - Protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men
AU - Yeap, Bu Beng
AU - Marriott, Ross James
AU - Adams, Robert J.
AU - Antonio, Leen
AU - Ballantyne, Christie M.
AU - Bhasin, Shalender
AU - Cawthon, Peggy M.
AU - Couper, David John
AU - Dobs, Adrian S.
AU - Flicker, Leon
AU - Karlsson, Magnus
AU - Martin, Sean A.
AU - Matsumoto, Alvin M.
AU - Mellström, Dan
AU - Norman, Paul E.
AU - Ohlsson, Claes
AU - Orwoll, Eric S.
AU - O'Neill, Terence W.
AU - Shores, Molly M.
AU - Travison, Thomas G.
AU - Vanderschueren, Dirk
AU - Wittert, Gary A.
AU - Wu, Frederick C.W.
AU - Murray, Kevin
N1 - Funding Information:
Funding AIMS is funded by a Western Australian Health Translation Network (WAHTN) Medical Research Future Fund Rapid Applied Translation Grant (2018). The ARIC study is funded by has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract nos. (HHSN268201700001I, HHSN268201700002I, HHSN268201700003I, HHSN268201700005I, HHSN268201700004I) and Dr. Ballantyne received NIH grant support through R01HL134320 The 1994/1995 Busselton Health Survey was supported by the Western Australian Health Promotion Foundation. The Cardiovascular Health Study was supported by contracts HHSN268201200036C, HHSN268200800007C, HHSN268201800001C, N01HC55222, N01HC85079, N01HC85080, N01HC85081, N01HC85082, N01HC85083, N01HC85086, and grants U01HL080295 and U01HL130114 from the National Heart, Lung, and Blood Institute (NHLBI), with additional contribution from the National Institute of Neurological Disorders and Stroke (NINDS). Additional support was provided by R01AG023629 from the National Institute on Aging (NIA). A full list of principal CHS investigators and institutions can be found at CHS-NHLBI.org. The EMAS Study is funded by The Commission of the European Communities Fifth Framework Programme ‘Quality of Life and Management of Living Resources’ Grant No. QLK6-CT-2001-00 258 and supported by Arthritis Research UK. The Framingham Heart Study of the National Heart Lung and Blood Institute of the National Institutes of Health and Boston University School of Medicine has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92019D00031. The HIMS study is funded by project grants from the National Health and Medical Research Council of Australia. The MAILES Study is funded by a project grant from the National Health and Medical Research Council of Australia (627227). The MrOS Sweden Study is funded by The Swedish Research Council and Swedish ALF funding. The Osteoporotic Fractures in Men (MrOS) Study is supported by National Institutes of Health funding. The following institutes provide support: the National Institute on Aging (NIA), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Center for Advancing Translational Sciences (NCATS) and NIH Roadmap for Medical Research under the following grant numbers: U01 AG027810, U01 AG042124, U01 AG042139, U01 AG042140, U01 AG042143, U01 AG042145, U01 AG042168, U01 AR066160 and UL1 TR000128.
Publisher Copyright:
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
PY - 2020/5/11
Y1 - 2020/5/11
N2 - 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.
AB - 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.
KW - epidemiology
KW - general endocrinology
KW - sex steroids & HRT
UR - http://www.scopus.com/inward/record.url?scp=85084548265&partnerID=8YFLogxK
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U2 - 10.1136/bmjopen-2019-034777
DO - 10.1136/bmjopen-2019-034777
M3 - Article
C2 - 32398333
AN - SCOPUS:85084548265
SN - 2044-6055
VL - 10
JO - BMJ open
JF - BMJ open
IS - 5
M1 - e034777
ER -