@everythingthelighttouches
Thank you
sultanasofa
There don't appear to have been any serious adverse events and suicidaility was not reported as an adverse event at all.
If I treat a cohort of cancer patients with an experimental new drug, especially if I don’t have a control group, and the patients become more unwell than they were at baseline, I must stop the trial.
The data you’ve just explained and quoted doesn’t match what was reported after the preliminary findings, so I’m a bit confused.
www.bbc.co.uk/news/health-49036145
Perhaps the preliminary findings were before the 12 month time point?
Thanks for alerting me to this.
The BBC report links to the 2015 board papers which contain the Preliminary Results from the Early Intervention Research in Appendix 7. In all 30 participants, and in the 16 natal girls, there was a statistically significant increase in the scoring for “I deliberately try to hurt or kill self” from baseline to after a year on puberty suppression. The table shows the means and SD, rather than the medians and IQR, as in the manuscript.
Self-harm
Looking at two self-harm items measured by the YSR, a significant increase was found in the first item “I deliberately try to hurt or kill self”. Adolescents had the option to score these items as: not true, sometimes true, often true. More adolescents tend to score this item in the “sometimes true - range” at T1 compared to T0, especially natal girls.
T0: Baseline (After Second / third appointment at the GIDS)
T1: 1 year on puberty suppression
I've attached the table of results as an image
So why are the results different?
Firstly the preliminary results look at changes for each of the two self-rated statements individually. The results in the manuscript adds together the two self-rated statements and report this as a self-harm score.
Secondly it is notable that the table of preliminary results presents the results as means and the manuscript as medians. Perhaps someone else who knows more about the Wilcoxon test could comment on statistical methodology?
Thirdly it may be that the results were different for the first 30 participants than when the total 44 were included.