Clinical Research Oriented Workshop (CROW) Meeting: July 28, 2010

Present: Amanda Kennedy, Rodger Kessler, Ben Littenberg, Charlie MacLean, Carole McBride, Connie van Eeghen (via Skype)

1. Round Table: Rodger wanted to know if, after starting a grant, if the staff aren’t hired until later, what happens to the funds? Ben: most grants have flexible funding, such that unspent funds can be rebudgeted to another line item in the project (assuming appropriate expenses, of course). There is usually a 25% limit before reporting is necessary. Money can also be rolled over to the next year and can be asked to extend the project for longer than the grant originally was limited to.

2. Carole’s Discussion: To what degree are the poor outcomes related to pregnancy/childbirth after IVF conception related to the intervention vs. the underlying medical issues?

a. Considered different ways of constructing a study. Issues included:
i. Separately studying the anovulatory subjects as a group
ii. Focusing on one specific intervention
iii. Variations in qualification for IVF
iv. Comparisons between the outcomes of different diagnoses related to pregnancy which were treated by the same intervention
v. High volume of data needed
vi. Comparisons between mothers of the same age (and other characteristics) with different histories of an intervention, although the ability to explain may not be high
b. Next step is to narrow done what can be studied to move in one of the above directions
i. Do the traditional risks apply in the population?
ii. What are the key risk factors for this population?
iii. Differences in geographic/national/cultural populations?
iv. Study the complication rate by treatment.
v. Study the time taken to delivery in good and bad outcome cases, adjusting for interventions: P(obstetric misadventure|conception) = f(time since diagnosis & age & maternal weight & treatment intensity)
1. Depends on a model of toxicity of treatment, e.g. does it wear off over time or is it permanent
2. Analysis by different negative outcomes, e.g. low birth weight
c. Approach: data base request to DBA – ask for unfiltered data; do the filters yourself
3. Amanda’s question: student approach to research
a. Writing a protocol for a physician for which the plan is for paramedics to intubate in the field
b. ED docs to conduct a field based RCT for two different airway procedures
i. Primary outcome: success with ventilation (not yet specified)
ii. Randomize by day of month, e.g. Wednesday codes are procedure A.
iii. Question: can the codes be randomized by day or should they be randomized by event
1. Can be randomized by day but introduces clustering without need; needs to be controlled
2. Risk of non-compliance for paramedics is worth considering
3. Consider randomizing the paramedic, rather than the day
4. Best scenario: identifying the intervention after the decision has been made to intubate
c. Key: the study team needs to know that the flaws in the design gives ammunition to those who decide, once the results are complete, that they are not happy

4. Next Fellows Meeting(s): Wednesday, 2:00 – 3:30 p.m., at Given Courtyard Level 4
a. Aug 4: Diantha Howard and Liz Chen: REDCap training (no Connie, Matt) – NOTE NEW LOCATION: 3rd floor (S359)
b. Aug 11: Connie’s qualitative study on quality – members will be asked to perform analysis; slides to be mailed out one week ahead (no Matt). Need to start at 2:30
c. Aug 18: (No Connie)
d. Aug 25:
e. Future agenda to consider:
i. Rodger: Mixed methods article
ii. Future: Review of different types of journal articles (lit review, case study, original article, letter to editor…), when each is appropriate, tips on planning/writing (Abby)
iii. Future: Informed consent QI: Connie to follow up with Nancy Stalnaker, Alan Rubin will follow up with Alan Wortheimer or Rob McCauly
iv. Kairn will ask a librarian to join us for selected issues

5. Fellows document – nothing this time – to be reviewed after trialing Wednesday meeting times, which started May 5, 2010.

Recorder: Connie van Eeghen