p.s. I've been consistently spelling injectAble wrong for 3+ years now.
18.07.2025 15:12 โ ๐ 0 ๐ 0 ๐ฌ 0 ๐ 0@danieljgrint.bsky.social
Associate Prof of Medical Statistics @lshtm.bsky.social | TB and HIV treatment trialist | Electronic health records analyst | Ultramarathoner
p.s. I've been consistently spelling injectAble wrong for 3+ years now.
18.07.2025 15:12 โ ๐ 0 ๐ 0 ๐ฌ 0 ๐ 0The front page of the preprint article, showing title and authors
The abstract of the preprint
Forest plot showing primary and secondary trial outcomes, with non-inferiority margins
โก๏ธNew preprint (not peer-reviewed)โก๏ธ
In the SaDAPT trial with people with #HIV and #tuberculosis symptoms in ๐ฒ๐ผ๐ฑ๐ธ, we investigated if antiretroviral therapy should be initiated immediately, or delayed until TB results available. ssrn.com/abstract=523...
Outcomes (incl. IRIS) similar across both arms.
Delighted to see our long-acting injectible ART trial (IMPALA) presented at #IAS2025. 2-monthly injections are non-inferior to daily pill taking and overwhelmingly preferred. Next challenge is expanding access to LA ART; excellent news the WHO has recommended LA CAB+RPV in treatment guidelines.
18.07.2025 15:03 โ ๐ 2 ๐ 1 ๐ฌ 1 ๐ 0Yeah, that part could definitely be better written. 10% mortality reduction is impressive!
18.07.2025 07:46 โ ๐ 0 ๐ 0 ๐ฌ 0 ๐ 0Interpretation beyond that is for the reader. It's possible these results could still change guidelines.
17.07.2025 10:25 โ ๐ 1 ๐ 0 ๐ฌ 1 ๐ 0I think you'd probably be right to, assuming there are no potential ill effects. 'Statistical significant' i.e. <0.05 is less of a thing now, but you still have to respect the study design. In this case, they just missed the pre-defined superiority criteria and must report on those lines.
17.07.2025 10:18 โ ๐ 1 ๐ 0 ๐ฌ 1 ๐ 0You don't need a Bayesian analysis to be less rigid in interpreting p- values. You're right the result looks promising, but it requires further study.
17.07.2025 09:52 โ ๐ 1 ๐ 0 ๐ฌ 1 ๐ 0Mandating culture/PCR for everyone in a vaccine trial makes sense to me, I didn't realise that wasn't the case. But it could (likely will) end up costing more even if the sample size is lower.
05.07.2025 13:36 โ ๐ 0 ๐ 0 ๐ฌ 0 ๐ 0Very interesting. In TB treatment trials, it's standard practice to test culture from everyone every few months regardless of symptoms. Consecutive positives define TB relapse without worrying about symptoms. However, this is a big cost driver!!!
05.07.2025 13:35 โ ๐ 1 ๐ 0 ๐ฌ 1 ๐ 0Describing the hawkeye automated line calling at Wimbledon as 'AI' can seriously get in the sea.
05.07.2025 11:46 โ ๐ 1 ๐ 0 ๐ฌ 0 ๐ 0add 10% to the quote you see when shopping around is my philosophy once it's been through the booking agent
26.06.2025 08:30 โ ๐ 0 ๐ 0 ๐ฌ 0 ๐ 0Until there is a test for TB infection with higher specificity than IGRA, the use of the non-inferiority trial design for TB vaccine prevention of infection outcomes is not recommended.
@richardwhite321.bsky.social @cfmcquaid.bsky.social @reinhouben.bsky.social
TB vaccine trials testing a non-inferiority hypothesis with an infection primary outcome must account for the imprecision in the tools used to define infection, otherwise vaccines may be falsely declared non-inferior.
25.06.2025 20:21 โ ๐ 0 ๐ 0 ๐ฌ 1 ๐ 0With only modest departures from perfect specificity in tuberculosis infection markers (95% for both), the risk of falsely declaring a vaccine to be non-inferior to BCG (or any other active control) is substantial.
25.06.2025 20:19 โ ๐ 0 ๐ 0 ๐ฌ 1 ๐ 0๐จ NEW PRE-PRINT (currently going through peer review)
We conducted a statistical simulation study to assess the impact of imperfect sensitivity and specificity, in the primary outcome definition of tuberculosis infection, in vaccine trials testing a non-inferiority hypothesis.
NEW PRE-PRINT (currently going through peer review)
In this secondary analysis of the RIFASHORT trial we classified TB disease severity at baseline and show that for the majority of people 4-months of rifampicin-based treatment, without the use of a quinolone, was non-inferior to the 6-month SOC.
there's a Simpson's meme for everything
13.06.2025 13:52 โ ๐ 1 ๐ 0 ๐ฌ 0 ๐ 0@sgschumacher.bsky.social @tomayates.bsky.social @reinhouben.bsky.social @richardwhite321.bsky.social @catherineberry.bsky.social @tb-lshtm.bsky.social
13.06.2025 08:26 โ ๐ 2 ๐ 0 ๐ฌ 0 ๐ 0Optimising the use of currently available treatments through treatment stratification could reduce treatment duration by 2-months for the majority. TB treatment stratification strategies should be prospectively trialled in a phase III RCT.
#TBSky
Among the majority who were classified as having limited TB disease at baseline, 4-months of treatment, including rifampicin at 1200mg but no quinolone, was non-inferior to the 6-month standard of care.
This study adds to the body of evidence that the majority of people are over-treated for TB.
We used baseline TB disease severity markers (Xpert cycle threshold and CXR grading) to define a TB disease phenotype (limited- and extensive-disease). Importantly for programmatic settings, we also show that Xpert CT alone was sufficient at identifying the limited-disease phenotype.
13.06.2025 08:20 โ ๐ 2 ๐ 0 ๐ฌ 1 ๐ 0NEW PRE-PRINT (currently going through peer review)
In this secondary analysis of the RIFASHORT trial we classified TB disease severity at baseline and show that for the majority of people 4-months of rifampicin-based treatment, without the use of a quinolone, was non-inferior to the 6-month SOC.
If you are at a loose end next Tuesday, come hear me and @danieljgrint.bsky.social talk about endpoints in TB trials
Hybrid event, in London and online
Most of the same ideas available in written form here
www.thelancet.com/journals/lan...
#IDSky #TBSky @sgschumacher.bsky.social
Not a fan of the Estonian song?
17.05.2025 23:10 โ ๐ 0 ๐ 0 ๐ฌ 1 ๐ 0But then again, everyone gets statins. Maybe the same approach is appropriate here. Might depend on how you see these drugs as either treatment for obesity or prevention against what comes down the line.
17.05.2025 12:15 โ ๐ 2 ๐ 0 ๐ฌ 2 ๐ 0Only so much public health can do when society has embraced 'just eat' culture. (I also like takeaways). I suspect this culture hasn't gripped Japan the same. Trt will be appropriate for some, but it shouldn't be widely used IMO, + limits on use for people who put the weight straight back on.
17.05.2025 10:54 โ ๐ 0 ๐ 0 ๐ฌ 1 ๐ 0Popularity contest. Fixed, I might say.
16.05.2025 07:57 โ ๐ 1 ๐ 0 ๐ฌ 1 ๐ 0I get strong Dopesick season 2 vibes from these weight loss drugs, though I'm sure they'll work for some people
14.05.2025 20:43 โ ๐ 1 ๐ 0 ๐ฌ 1 ๐ 0