OR25-05 Clinical Predictors Of Symptomatic Benefit In Men With Low Testosterone During Testosterone Treatment Compared With Placebo: Results Of Individual Patient And Aggregate Data Meta-analyses
Bibliographic record
Abstract
Abstract Disclosure: J. Hudson: None. M. Cruickshank: None. R. Quinton: Speaker; Self; Bayer Schering Pharma, Besins. L. Aucott: None. F.C. Wu: None. M. Grossmann: None. S. Bhasin: None. P.J. Snyder: None. S. Ellenberg: None. T.G. Travison: None. G.B. Brock: None. E.J. Gianatti: None. Y.T. van der Schouw: None. M.H. Emmelot-Vonk: None. E. Giltay: None. H. Geoff: None. S. Ramachandran: None. J.B. Svartberg: None. K.L. Hildreth: None. K. Groti Antonic: None. J.S. Tenover: None. H. Tan: None. C. Ho Chee Kong: None. T. Wei Shen: None. L.S. Marks: None. R.J. Ross: None. R.S. Schwartz: None. S. Roberts: None. M. Andersen: None. L. Magnussen: None. M. Aceves-Martins: None. S. Bhattacharya: None. W.S. Dhillo: None. M. Brazzelli: None. C.N. Jayasena: Grant Recipient; Self; Logixx Pharma Ltd. Background: Testosterone treatment increases the international index of erectile function 15 (IIEF-15) in young men with pathological hypogonadism. However, testosterone is most frequently prescribed to middle-aged and older men, and men with obesity, whose sexual dysfunction may be unrelated to their low testosterone; prior studies suggest that symptomatic responses to testosterone treatment may be attenuated in older men and those with obesity. To identify subgroups of men with low testosterone experiencing the greatest symptomatic benefit during testosterone therapy, we utilised individual participant data (IPD) from the Testosterone Efficacy and Safety (TestES) Consortium. Methods: Systematic review of randomised controlled trials including IPD meta-analysis (PROSPERO CRD42018111005) identifying clinical efficacy outcomes, and subgroups associated with outcomes in RCTs comparing testosterone with placebo in men with baseline total testosterone <12nmol/L (348ng/dL). One-stage meta-analyses used IPD, and two-stage meta-analyses integrated IPD with aggregate data from studies not providing IPD. Findings: Seventeen of 35 trials provided IPD (3431/5601 participants; mean duration 9.5months; 97% men aged >40years). As expected, testosterone increased IIEF-15 compared with placebo (MD 5.52 (95% CI 3.95, 7.10; τ^2=1.17). However, no significant increment in IIEF-15 during testosterone compared with placebo was observed in smokers (interaction -9.03, 99% CI -48.90, 30.84). Increases in IIEF-15 during testosterone compared with placebo were not associated with patient age, obesity, presence of diabetes, or baseline total testosterone. However, absolute levels of sexual function achieved during testosterone treatment were subject to thresholds in patient age (mean IIEF-15: 46.8 (19.4), <52 years; 38.8 (21.9), 52-70 years; 26.8 (21.1), >70 years; P<0.001), body mass index (BMI) (mean IIEF-15: 40.0 (22.2), <30.6kg/m2; 34.4 (21.9), ≥30.6kg/m2; P<0.001), and baseline serum testosterone (mean IIEF-15: 42.2 (23.9), ≥9.8nmol/L; 30.7 (22.1), <9.8nmol/L; P<0.001). Interpretation: In men aged >40 years with serum baseline testosterone <12nmol/L, we were surprised to observe that increments in IIEF-15 during testosterone treatment are not significantly affected by age, obesity, or baseline testosterone status. However, baseline factors may influence the absolute post-treatment IIEF-15 achieved during testosterone treatment. Funding: National Institute for Health Research Health Technology Assessment programme (NIHR HTA 17/68/01). Presentation Date: Saturday, June 17, 2023
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".