TY - JOUR
T1 - No evidence found for an association between trial characteristics and treatment effects in randomized trials of testosterone therapy in men
T2 - a meta-epidemiological study
AU - Haring, Robin
AU - Ghannad, Mona
AU - Bertizzolo, Lorenzo
AU - Page, Matthew J.
PY - 2020/6
Y1 - 2020/6
N2 - Objective: The objective of this study was to identify potential trial characteristics associated with reported treatment effect estimates in randomized trials of testosterone therapy in adult men. Study Design and Setting: This is a meta-epidemiological study. MEDLINE was searched for meta-analyses of randomized trials of testosterone therapy in men published between 2008 and 2018. Data on trial characteristics were extracted independently by two reviewers. The impact of trial characteristics on reported treatment effects was investigated using a two-step meta-analytic approach. Results: We identified 132 randomized trials, included in 19 meta-analyses, comprising data from 10,725 participants. None of the investigated design characteristics, including year of publication, sample size, trial registration status, center status, regionality, funding source, and conflict of interest were statistically significantly associated with reported treatment effects of testosterone therapy in men. Although trials rated at high risk of bias overall reported treatment effects that were 21% larger compared with trials rated at low risk of bias overall, the 95% confidence interval included the null (ratio of odds ratio: 0.79, 95% confidence interval: 0.60 to 1.03). Conclusion: The present study found no clear evidence that trial characteristics are associated with treatment effects in randomized trials of testosterone therapy in men. To establish stronger evidence about the treatment effects of testosterone therapy in men, future randomized trials should not only be adequately designed but also transparently reported. Study Registration: osf.io/x9g6m.
AB - Objective: The objective of this study was to identify potential trial characteristics associated with reported treatment effect estimates in randomized trials of testosterone therapy in adult men. Study Design and Setting: This is a meta-epidemiological study. MEDLINE was searched for meta-analyses of randomized trials of testosterone therapy in men published between 2008 and 2018. Data on trial characteristics were extracted independently by two reviewers. The impact of trial characteristics on reported treatment effects was investigated using a two-step meta-analytic approach. Results: We identified 132 randomized trials, included in 19 meta-analyses, comprising data from 10,725 participants. None of the investigated design characteristics, including year of publication, sample size, trial registration status, center status, regionality, funding source, and conflict of interest were statistically significantly associated with reported treatment effects of testosterone therapy in men. Although trials rated at high risk of bias overall reported treatment effects that were 21% larger compared with trials rated at low risk of bias overall, the 95% confidence interval included the null (ratio of odds ratio: 0.79, 95% confidence interval: 0.60 to 1.03). Conclusion: The present study found no clear evidence that trial characteristics are associated with treatment effects in randomized trials of testosterone therapy in men. To establish stronger evidence about the treatment effects of testosterone therapy in men, future randomized trials should not only be adequately designed but also transparently reported. Study Registration: osf.io/x9g6m.
KW - Men
KW - Meta-research
KW - Randomized trial
KW - Risk of bias
KW - Testosterone
UR - http://www.scopus.com/inward/record.url?scp=85082202968&partnerID=8YFLogxK
U2 - 10.1016/j.jclinepi.2020.02.004
DO - 10.1016/j.jclinepi.2020.02.004
M3 - Article
C2 - 32105799
AN - SCOPUS:85082202968
SN - 0895-4356
VL - 122
SP - 12
EP - 19
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
ER -