Several high quality trials have investigated the clinical benefits and risks of androgen replacement therapy (ART) in men with symptomatic low testosterone. Nevertheless, there remains uncertainty among clinicians regarding the clinical benefits and harm associated with. Accordingly, prescriptions have doubled and prescription costs have increased eight-fold in the UK since 2001, without any increase in the prevalence of hypogonadism. The National Institute of Health Research (NIHR) has commissioned and funded this study to systematically review the literature on the use of ART in symptomatic men with testosterone deficiency. The overarching aim of the project is to integrate the current quantitative, qualitative and economic evidence for the use of ART in symptomatic men with testosterone deficiency syndrome. This will include the following specific objectives:
- Evidence synthesis including an individual participant data meta-analysis (IPD MA) to estimate the clinical effectiveness and safety of ART for men with testosterone deficiency syndrome and to inform key parameters for the development of a decision model.
- Synthesis of the existing qualitative evidence, which reports men’s experience and acceptability of ART.
- Decision model to estimate the cost-effectiveness of ART for the treatment of symptomatic men with testosterone deficiency syndrome.
Results of this evidence synthesis and economic evaluation will provide clinicians and men with updated, personally relevant information on which to form their evidence-based decisions and, therefore, are likely to impact on current clinical practice, both at national and international level.
The project, which starts in September 2018, is funded for 24 months.
- Miriam Brazzelli; email@example.com