Research Correspondence Archive
7A-SUPP-001 — Vale Correspondence, 2011–2013
| Parties: | Dr. M. Ellison (Somnatek) & Dr. E. Vale (Wexler University) |
| Period: | September 2011 – April 2013 |
| Archive status: | Transferred — Dorsal Health Holdings LLC (2014-11-03) |
This correspondence was archived as part of the Protocol 7A supplemental records package. Some messages have been omitted from this archive. The original file is retained by Dorsal Health Holdings LLC. Messages are presented in chronological order.
From: Edwin Vale <e.vale@wexler.edu>
To: Mara Ellison <mellison@somnatek.org>
Date: September 7, 2011
Re: Q3 cross-reference analysis
Mara,
Completed the Q3 cross-reference pass. I want to walk through the numbers with you before I put anything in writing for the department.
We now have eleven participants who have independently reported the corridor element, nine who have reported the blue door with consistent positional placement, and — and this is the part I want to discuss — seven who have reported the room number. I haven't confirmed the number across all seven yet. I'll need your session notes for PTX-007 session 22 and PTX-031 session 18. Can you send those over?
I want to be careful about how we characterize this in the Q3 summary. The department will ask about cross-contamination. We need to be confident in our isolation protocol before we make any inter-participant consistency claim in writing.
Edwin
From: Mara Ellison <mellison@somnatek.org>
To: Edwin Vale <e.vale@wexler.edu>
Date: September 9, 2011
Re: Q3 cross-reference analysis
Edwin,
Notes attached for PTX-007 S22 and PTX-031 S18.
On the question of cross-contamination — I want to be direct. Our isolation protocol has been rigorous. Lena has been consistent. The participants don't know each other and have never been scheduled in overlapping time windows. What they're reporting is not contamination.
I'm not saying we lead with that. I'm saying we need to stop pretending it's a confound to be explained away. We agreed when we started this study that we'd follow the data wherever it went.
The number is 413 across all seven. I've checked.
Mara
From: Edwin Vale <e.vale@wexler.edu>
To: Mara Ellison <mellison@somnatek.org>
Date: September 12, 2011
Re: Q3 cross-reference analysis
Mara,
Confirmed. 413 across all seven confirmed cases. PTX-018 S20 is the most recent. I've updated the cross-reference table.
I hear what you're saying about following the data. I agree with you in principle. I'm also responsible to the department and to the ethics board. We're going to need to decide what gets into the formal record and what stays in the supplemental index.
For now I think we document everything in the supp index and keep the summary language conservative. The ethics board amendment we filed last spring gave us room to extend the observation scope without disclosing the specific target elements to participants. That's the framework we're working in.
What I can't do is sit in front of the department and say that eleven people are independently reporting the same numbered room without being able to explain the mechanism.
Edwin
From: Mara Ellison <mellison@somnatek.org>
To: Edwin Vale <e.vale@wexler.edu>
Date: September 14, 2011
Re: Q3 cross-reference analysis
Edwin,
The mechanism isn't the question I'm losing sleep over.
The question I'm losing sleep over is whether it matters that the door hasn't opened for any of them yet.
Mara
From: Edwin Vale <e.vale@wexler.edu>
To: Mara Ellison <mellison@somnatek.org>
Date: March 3, 2012
Re: Recall escalation — PTX-018, PTX-007
Mara,
Following up on the escalation flags from the February sessions.
PTX-018 S20: participant confirmed 413 unprompted. I've added this to the cross-reference table. This brings the confirmed count to nine.
PTX-007 S24: participant reported what sounds like access. I want to be precise here because I know how this is going to read. Participant described standing at the door. Described a sound. Described the door as open.
I need the full debrief transcript for S24, not the summary form. This is the first access-consistent report in the cohort.
Edwin
From: Mara Ellison <mellison@somnatek.org>
To: Edwin Vale <e.vale@wexler.edu>
Date: March 5, 2012
Re: Recall escalation — PTX-018, PTX-007
Edwin,
Transcript attached. Lena's notes are included.
I want to flag something separate. I ran the full session log last night. PTX-007 is not the only one. PTX-014 S22 has a description that I think is consistent with the same access event — patient described "going through." Used that phrase three times. I didn't flag it at the time because the session summary was otherwise unremarkable.
I've also been thinking about PTX-018. The patient asked Lena last year what was at the end of the hallway. We didn't address it. But I keep coming back to that question. They're asking because they already know something is there. They're not asking what it looks like. They're asking if we know.
Mara
From: Edwin Vale <e.vale@wexler.edu>
To: Mara Ellison <mellison@somnatek.org>
Date: March 8, 2012
Re: Recall escalation — PTX-018, PTX-007
Mara,
I've read the transcript and Lena's notes twice.
I need to think about what the ethics board amendment actually authorized us to do here. The original scope was observation. Passive documentation of independent recall consistency. The amendment extended the checklist. Neither document said anything about this.
I'm going to talk to C. Aldridge tomorrow about the Q1 summary language. I don't think we can include PTX-007 S24 in the public record. The supplemental index is the right place for this.
I'll call you Friday.
Edwin
From: Edwin Vale <e.vale@wexler.edu>
To: Mara Ellison <mellison@somnatek.org>
Date: November 14, 2012
Re: Study withdrawal — Wexler
Mara,
I've been asked by the department to submit a formal withdrawal of the study from the Wexler research registry. The request came from above my level. I wasn't given a detailed reason. The language I was given is "completion of primary observation period."
I disagree with that characterization. I want you to know that. The study is not complete. We both know that.
I'm going to file the withdrawal as instructed. The supplemental data will remain in my possession. I will not be transferring it to the department.
I'd like to speak before you proceed with any further sessions.
Edwin
From: Mara Ellison <mellison@somnatek.org>
To: Edwin Vale <e.vale@wexler.edu>
Date: November 16, 2012
Re: Study withdrawal — Wexler
Edwin,
I understand. I'd also like to speak before you file.
I don't know who above your level made that request or why, and I'm not going to speculate in writing. But I want to ask you something directly, and I'm asking you as a colleague and not as a co-investigator: is the withdrawal coming from the department, or is it coming from somewhere else?
Because I've had a similar conversation recently that I can't go into here.
Mara
From: Mara Ellison <mellison@somnatek.org>
To: Edwin Vale <e.vale@wexler.edu>
Date: April 2, 2013
Re: [no subject]
Edwin,
I want to be careful about what I write here.
I've been in room 413. Not in a session. Not as an observer. I was in the building after hours on Thursday and I went down the corridor and the door was unlocked.
I don't know what to do with that.
The room is not on the standard environmental checklist. That was my instruction to Lena in 2010. At the time I thought I was being cautious. I'm less sure what I was being now.
I've started writing up what I saw. I don't know if I'll send it. I'm going to sit with it for a while.
Please don't forward this.
Mara
From: Edwin Vale <e.vale@wexler.edu>
To: Mara Ellison <mellison@somnatek.org>
Date: April 4, 2013
Re: [no subject]
Mara,
I won't forward it.
I want to ask you something. When PTX-018 asked Lena what was at the end of the hallway — did they seem like they were asking because they didn't know? Or because they wanted to know if we did?
I've been thinking about that session note for two years.
Please send what you wrote. Whatever you're willing to share.
Edwin
From: Mara Ellison <mellison@somnatek.org>
To: Edwin Vale <e.vale@wexler.edu>
Date: April 6, 2013
Re: [no subject]
Edwin,
They knew.
The write-up is attached. It's 14 pages. I'm sorry. I didn't mean for it to be that long.
I'm going to keep running sessions with the remaining participants. I don't think this ends when we stop scheduling.
Mara
This archive contains 17 of 31 messages in this correspondence thread. The remaining 14 messages have been omitted from this view. The complete correspondence file is retained by Dorsal Health Holdings LLC.