Present: Levi Bonnell, Marianne Burke, Justine Dee, Nancy
Gell, Juvena Hitt, Ben Littenberg, Jen Oshita, Gail Rose, Liliane Savard, Adam
Sprouse-Blum, Mariana Wingood, Connie van Eeghen, Sylvie Frisbie, Emily
Tarleton, Lisa W Natkin (14)
1.
Warm Up: Welcome back,
everyone
2.
Ben & Emily: review process includes patients, advocates, and other stakeholders; due
Sept 29
a.
Must be engaging and accessible to those
who are not immersed in research
b.
Objectives for this review: what are the
barriers to approval for full application
c.
Cone of Silence descends: Ben, Gail,
Emily, Lisa
d.
Title: does not reflect the patient, or
patient voice
e.
Background:
i.
No definition of depression
ii.
Language related to those affected and
relationship to cost
iii.
Consistency in referencing magnesium
iv.
Tie outcomes strongly to
patient-centered needs; what matters most to patients
v.
Does PICOT framework need more
explanation; tie to diagram
f.
Aims
i.
Aim 3: what is “uptake” intended to mean
here
g.
Comparators: clarify “adequate amounts”
and the safety of the proposed dosing
i.
Explain why serum magnesium is a good
measure; tie to blood samples
ii.
How will clinical remission be
determined
iii.
Explanation of dosage: need to clarify
the target dosage
h.
Population
i.
What was the basis for choosing the
subgroups for analysis; provide justification.
1.
Some groups are co-linear; how was that
included in estimate of sample size
ii.
Clearer learning: what is being looked
at and with which specific groups
iii.
How will information about
remission/change be communicated with PCPs?
i.
Engagement
i.
Specific engagement of people with
experience in depression; characterize what this diagnosis is and the dilemma
of making choices – this goes back to “what matters most to patients,” above
ii.
Specify what engagement looks like
j.
Design
i.
Can the design be changed to a blinded
study?
k.
Discussion (Cone of Silence lifts)
i.
There is a discussion of the placebo
effect and this is a pragmatic trial, so a placebo is not possible and is not
the purpose of a CER
ii.
Challenges
1.
Limited space with lengthy explanations
needed
2.
Specific instructions made some language
requirements
iii.
Why focus on mild to moderate – this is
worth reconsideration
iv.
Dosing issues are based on a pilot with
no placebo; emphasize the patient-centered approach to a dose-response strategy
v.
Rationale for Mg chloride vs Mg citrate
3.
Next week: ?? Levi will figure it out.
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