Androgens In Men Study (AIMS): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men.

TitleAndrogens In Men Study (AIMS): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men.
Publication TypeJournal Article
Year of Publication2020
AuthorsYeap BBeng, Marriott RJames, Adams RJ, Antonio L, Ballantyne CM, Bhasin S, Cawthon PM, Couper DJ, Dobs AS, Flicker L, Karlsson M, Martin SA, Matsumoto AM, Mellström D, Norman PE, Ohlsson C, Orwoll ES, O'Neill TW, Shores MM, Travison TG, Vanderschueren D, Wittert GA, Wu FCW
Secondary AuthorsMurray K
JournalBMJ Open
Volume10
Issue5
Paginatione034777
Date Published2020 05 11
ISSN2044-6055
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.

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.

DOI10.1136/bmjopen-2019-034777
Alternate JournalBMJ Open
PubMed ID32398333
PubMed Central IDPMC7239545
Grant ListU01 HL080295 / HL / NHLBI NIH HHS / United States
U01 AG042124 / AG / NIA NIH HHS / United States
N01HC85086 / HL / NHLBI NIH HHS / United States
HHSN268201700002C / HL / NHLBI NIH HHS / United States
U01 AG042140 / AG / NIA NIH HHS / United States
N01HC85083 / HL / NHLBI NIH HHS / United States
U01 AG042139 / AG / NIA NIH HHS / United States
UL1 TR000128 / TR / NCATS NIH HHS / United States
U01 HL130114 / HL / NHLBI NIH HHS / United States
R01 CA094143 / CA / NCI NIH HHS / United States
HHSN268200800007C / HL / NHLBI NIH HHS / United States
N01HC55222 / HL / NHLBI NIH HHS / United States
U01 AG042145 / AG / NIA NIH HHS / United States
HHSN268201200036C / HL / NHLBI NIH HHS / United States
HHSN268201800001C / HL / NHLBI NIH HHS / United States
HHSN268201700001I / HL / NHLBI NIH HHS / United States
U01 AG042168 / AG / NIA NIH HHS / United States
HHSN268201700004I / HL / NHLBI NIH HHS / United States
HHSN268201700005C / HL / NHLBI NIH HHS / United States
HHSN268201700001C / HL / NHLBI NIH HHS / United States
N01HC85082 / HL / NHLBI NIH HHS / United States
HHSN268201700003C / HL / NHLBI NIH HHS / United States
75N92019D00031 / HL / NHLBI NIH HHS / United States
HHSN268201700004C / HL / NHLBI NIH HHS / United States
U01 AG027810 / AG / NIA NIH HHS / United States
HHSN268201700002I / HL / NHLBI NIH HHS / United States
HHSN268201700005I / HL / NHLBI NIH HHS / United States
N01HC85079 / HL / NHLBI NIH HHS / United States
R01 AG023629 / AG / NIA NIH HHS / United States
R01 HL134320 / HL / NHLBI NIH HHS / United States
N01HC85080 / HL / NHLBI NIH HHS / United States
HHSN268201700003I / HL / NHLBI NIH HHS / United States
U01 AG042143 / AG / NIA NIH HHS / United States
U01 AR066160 / AR / NIAMS NIH HHS / United States
N01HC85081 / HL / NHLBI NIH HHS / United States
/ ARC_ / Arthritis Research UK / United Kingdom