Research protocol in HeartBEAT dataset

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[-] Mark Gardner +0 points · 7 months ago

Hi everyone. Firstly, thanks for the access to the dataset. It has been very interesting to work with.

My question is in regards to the HeartBEAT dataset. This may sound like a stupid question, but were the patients who were in the PAP and supplemental Oxygen therapy groups, being treated with their respective therapies in both the baseline and follow-up visits? That is, were the PAP patients using the PAP machines (and similarly for the supplemental oxygen device) whilst the baseline and follow-up datasets were being recorded? It is not clear whether this is the case in the dataset introduction and the referenced paper (Gottlieb, D. J. et al. (2014). CPAP versus oxygen in obstructive sleep apnea. The New England journal of medicine, 24, 2276–2285.)

Also is there any information about patient sleep stages that I have missed?

Regards, Mark

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[-] mrueschman +2 points · 7 months ago

Hey Mark,

To your second question: We didn't have EEG channels on the HeartBEAT Embletta studies, so we don't have sleep staging. Here's the montage information.

As to the first question, the randomization occurred after the screening/baseline sleep study and baseline clinic visit, so participants were not on any study treatment when the baseline data were collected. For follow-up, the study procedure was to have participants wear their assigned therapy on the night of the follow-up sleep study. That said, we of course had a non-trivial number of participants who were not adherent (in both Oxygen/PAP arms) who likely had elected to stop using the assigned therapy by the time follow-up rolled around.

From what I can tell, participants were not asked about whether they used their assigned therapy on the night of the follow-up sleep study, so I think this information will be elusive. Let me know if you want me to ping Dr. Gottlieb and one of our other staff who helped with the sleep scoring and therapy adherence tracking about this topic.

Thanks,

Mike

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[-] Mark Gardner +0 points · 7 months ago

Thanks for your reply Mike.

From what I can tell, participants were not asked about whether they used their assigned therapy on the night of the follow-up sleep study, so I think this information will be elusive. Let me know if you want me to ping Dr. Gottlieb and one of our other staff who helped with the sleep scoring and therapy adherence tracking about this topic.

This would be very helpful to me, as whether the subjects were using the assigned therapy is an important piece of information in my analysis of this data. Thanks for your effort.

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[-] mrueschman +1 point · 7 months ago

It dawned on me after replying yesterday that we have night-by-night adherence data for the PAP group, so we should be able to link this with the dates of follow-up sleep studies. We do not have nightly data from the oxygen concentrators, unfortunately.

I will follow-up with Dr. Gottlieb to see if he has any additional ideas. I will report back here in the next 1-2 weeks.

To be sure, you are looking for a dichotomous variable that indicates whether the participant is either 1) using or 2) not using their assigned therapy on the night of the follow-up sleep study, correct? Is there anything else you need along these lines?

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[-] Mark Gardner +0 points · 7 months ago

To be honest I'm really only looking at comparing the PAP patients with the control group, so the data for the oxygen therapy is not necessary.

To be sure, you are looking for a dichotomous variable that indicates whether the participant is either 1) using or 2) not using their assigned therapy on the night of the follow-up sleep study, correct?

Yes this is what I am after.

Thanks

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[-] mrueschman +0 points · 7 months ago

I am going to email you a link to a dataset momentarily. We can continue the conversation there.

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