Cardiovascular Outcome Trials: Next Steps

Event Details

Event Details are unavailable.

Agenda

October 27, 2017

8:00 a.m. – 8:15 a.m.

Welcome and COI declaration

8:15 a.m. – 11:15 a.m.

CVOTs
Moderator: John Buse

1. Problems/Outstanding Questions that might be Addressed with a Comparative Effectiveness Trial
   Darren McGuire (20 minute presentation, 10 minute discussion)
2. If We were to Conduct a Comparative Effectiveness Trial, What would it Look like?
   Joe Selby (20 minute presentation, 135 minute discussion, with 10 minute break)

11:15 a.m. – 2:00 p.m.

Can we conduct a pragmatic trial?
Moderator: Larry Fine
Adrian Hernandez
Russell Rothman
Jacquie Halladay

Questions:

1. Will it be compelling to PCP’s to engage patients in this research effort in the context of their clinical practice? Will they refer patients for recruitment and/or support EHR-based recruitment?
2. Will providers be willing to switch and manage patients on any of the three arms of the proposed study?
3. Will the randomization to study treatments and process of follow-up be acceptable to patients?
4. Will the workflow to capture study endpoints occur naturally in practices or will substantial additional support (i.e., research assistants) to the PCP’s be required for study procedures?
5. Will the study interventions and measures be implemented with adequate fidelity to test the hypothesis?
6. Will participants remain within systems of care that will allow adequate follow-up?
7. Since this trial will not have a placebo control, how can we ensure that there is no bias in identifying endpoints?
8. Are there barriers to recruitment of health care systems to participate in a pragmatic trial?

2:00 p.m. – 3:45 p.m.

Should we conduct such a trial?
Moderator: Barbara Linder

3:45 p.m. – 4:00 p.m.

Closing Remarks