Clinical Research Oriented Workshop (CROW) Meeting: Sept 10, 2020

 

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.