A couple months ago we discussed a controversial study of rectal artesunate suppositories. In addition to issues with the analysis, there was concern because the data were unavailable.
Following Dale Lehman’s suggestion, I went online on 10 Nov 2022 and submitted my data access request:
Record:
Dataset for: Effectiveness of rectal artesunate as pre-referral treatment for severe malaria in children under 5 years of age: a multi-country observational studyFull name:
Andrew GelmanEmail address:
[email protected]Justification:
The paper is on an important topic so it would be good for the data to be available.
The next day I received an email from one of the authors, Manual Hetzel, that they were coordinating to make the data available. On 22 Dec 2022, Hetzel sent me an update:
Regarding your request to access the dataset underlying the publication “Effectiveness of rectal artesunate as pre-referral treatment for severe malaria in children under 5 years of age: a multi-country observational study” deposited on Zenodo,
we have now made the dataset freely accessible (Creative Commons Attribution Non Commercial 4.0 International license). The files can be downloaded without restrictions.As I had mentioned in our previous exchange, we were hoping to provide free access in parallel with a response to a commentary to our paper in BMC Medicine. Unfortunately, this is taking longer than expected and the commentary and our response might only go online in January.
In any case, considering some of the comments on social media and on your blog, we feel it is crucial to understand our findings in their context. Two viewpoints just published in the Lancet Infect Dis (our view: https://doi.org/10.1016/S1473-3099(22)00762-9; Lorenz von Seidlein’s view: https://doi.org/10.1016/S1473-3099(22)00765-4) can provide some of this essential context as well as links to other publications with complementary findings.
In addition, I recommend the following publication that describes the purpose and context of the entire project in detail: PLOS Glob Public Health 2022; 2(9): e0000464. (https://doi.org/10.1371/journal.pgph.0000464).
I have no take on the study itself, just happy to report that the data are now available. I just got back from vacation last week and was going through my emails, and I’m scheduling this post for tomorrow.
Direct link to the data page
https://zenodo.org/record/5548261
Thanks for this Andrew. Having the data open access is important. My main concerns were about analysis and study conduct. In order to help understand how some of the aspects of the study were carried out, I asked them for the study protocol. They have flatly refused to share it with me. This is odd because study protocols are usually made openly available on publication.
Without knowing how they chose whether to give the drug or not it really is impossible to say much even with the data. If they gave the drug to “desperate cases” and found higher mortality it would hardly be surprising. If there was physician choice in who got the drug, then all the outcomes might tell you is whether the physicians made good decisions sort of convolved with whether the drug was good or bad… If there was a standardized decision then we might have a hope of making progress…