Clinical Research Oriented Workshop (CROW) Meeting: January 28, 2016

Present:  Marianne Burke, Nancy Gell, Kairn Kelley, Ben Littenberg, Adam Sprouse-Blum, Connie van Eeghen

Start Up:  Kairn’s scheduled defense date is March 25!

1.                  Discussion: Comparison of Dichotic Listening Test-Retest Reliability in Children manuscript – Results Section

a.       It’s coming along!

b.      Goal of this session: feedback, perceptions on the “point” of this paper, and discussion

c.       Target journal:  Journal of Speech Language Hearing Research (a switch to a more research oriented readership)

d.      Comments: feedback on language, style, focus, and presentation abounded.

e.       Exceptional outcomes – what to do with these?

                                                  i.      Older children (Words) had slightly more reliable scores; is this clinically important?

                                                ii.      Starting with Words resulted in a better second Words score, rather than those that started with Syllables or Digits

f.       Next steps:

                                                  i.      Finish the manuscript!

2.                  Next Workshop Meeting(s): NOTE NEW TIME: Thursdays, 1:30 p.m. – 2:30 p.m., at Given Courtyard South Level 4.   

a.       February 4, 2016: Kairn’s full manuscript

b.      February 11, 2016: Ben’s paper

Recorder: Connie van Eeghen

Clinical Research Oriented Workshop (CROW) Meeting: January 21, 2016

Present:  Kairn Kelley, Ben Littenberg, Charlie MacLean, Gail Rose, Connie van Eeghen

Start Up:  PowerPoint trick in presentation mode: “B” will black out the screen.

1.                  Discussion: CDC with Graham Center, who contracted with DARTNet: what data elements can predict DM; 8 sites providing data for analysis; UVM-MC is one site.  Rodger made a test request for data (see first slide/page of handout) and needs to improve the request.

a.       Goal: can we identify patients at risk for further developing pre-DM or DM that are not known to have DM (no dx or lab values that indicate DM)

                                                  i.      Who are documented as DM with no follow up

                                                ii.      Who are not documented as DM but has an indicative test result

                                              iii.      Who have no test results, but have risk factors that indicate likelihood of later DM à this is the CDC’s focus: currently unidentified pre-DM and DM

1.      How to predict the lab value of a patient today

                                              iv.      Who have a low test result, but have risk factors that indicate likelihood of later DM: predict the lab value of a patient in the future (interesting and different, but not the CDC’s focus)

b.      Risk factors of interest are known (see second slide in handout)

                                                  i.      Missing: Waist size

                                                ii.      Study: machine learning, using one of a variety of methods

                                              iii.      Question as to whether it is likely to produce a useful predictor, especially since the screen is simple, fast, and cheap (A1c)

c.       UVM-MC has clarified its process for data requests

                                                  i.      Preferred: patient record data

                                                ii.      Alternative: summary records – but these are vulnerable to misinterpretation of the analytic request

                                              iii.      Many requests are developed with the help of Allison Holmes

                                              iv.      Philosophically, better to get all patient records (DM or not), rather than looking for specific risk factors up front (e.g. don’t just look for A1c results, or other clinical outcomes that depend on an assumption about whom to collect those data from)

d.      Next steps:

                                                  i.      Start practicing yoga

                                                ii.      Tell Wilson that these data are accessible from UVM-MC

                                              iii.      Think about who in DARTNet can communicate with the data extractor at each site

2.                  Next Workshop Meeting(s): NOTE NEW TIME: Thursdays, 1:30 p.m. – 2:30 p.m., at Given Courtyard South Level 4.   

a.       January 28, 2016: Kairn’s paper

b.      February 4, 2016: Ben’s paper

c.       February 11, 2016

Recorder: Connie van Eeghen

Abby Crocker on the long-term outcomes of babies who are born to opioid-dependent women

Assistant Professor (and CTS alumna) Abigail Crocker, PhD was featured on Vermont Public Radio for her work on the long-term  outcomes of babies who are born to opioid-dependent women.

http://digital.vpr.net/post/vermonts-opiate-crisis-will-have-long-lasting-impacts-kids#stream/0

Clinical Research Oriented Workshop (CROW) Meeting: January 14, 2016

Present:  Marianne Burke, Nancy Gell, Kairn Kelley, Jennifer Oshita, Gail Rose, Adam Sprouse-Blum, Connie van Eeghen

Start Up:  Introductions – welcome to Jennifer.

1.                  Discussion: Adam’s next research project on Migraine

a.       Review of his pilot study (2013 publication) on the use of cold therapy for Migraine

                                                  i.      Resulted in significant results, with limitations, and a product that is undergoing patent approval and is currently being sold by someone else (note: a timer added to the product, along with linkage to a smartphone, could add some additional distinctive features)

b.      Planning a proposal to SPARK (health related, novel interventions)

                                                  i.      Design plan: randomized concurrent controlled trial targeted carotid cooling in the treatment of the migraine patient with or without cross-over; rolling admissions

                                                ii.      Inclusion: adult patients (18-65), male or female, with episodic migraine (2-14 events/month)

1.      Need justification to exclude over 65 year old subjects

2.      Consider including everyone who shows up, including pregnant patients

                                              iii.      Exclusion: known or suspected disease of carotid artery, no change in preventive agent in last month or three months, “medication over-use” headache

                                              iv.      Process

1.      Patient identified

2.      Contact information given to medical assistant (paid for by SPARK)

3.      Review inclusion/exclusion criteria by phone

4.      Delivery of device, informed consent and demonstration

5.      Record data (0-4 attacks over 6(?) weeks

6.      MA pick up device and data

7.      Exit interview w/ blinding testing

8.      Submit data directly to statistician

                                                v.      Device: neck wrap connected to circulation device, set for a particular temperature

1.      Stays colder, colder longer, better controlled

2.      UVM has equipment to measure brain temperature

3.      Cost: over $2K/device

c.       Endpoints

                                                  i.      Primary: Pain free at 2 hours (0=no headache, 1=mild, 2=moderate, 3=severe) (typical measure for acute treatment)

                                                ii.      Secondary: recurrence of headache 2-48 hours after administration, nausea, phono-/photophobia, rescue medication use

d.      Purpose of the study: efficacy or effectiveness

                                                  i.      How does cooling effect brain temperature (fMRI, UVM research support)

                                                ii.      Do patients who use this intervention feel better

e.       Goals

                                                  i.      Find a source to pay for the device and the cost of the study

                                                ii.      Continue work in CTS: research and academics

                                              iii.      Staying for a research year, which includes clinical (1 day research now; more later)

                                              iv.      Consider accelerating publication rate to strengthen future applications (e.g. K award)

2.                  Next Workshop Meeting(s): NOTE NEW TIME: Thursdays, 1:30 p.m. – 2:30 p.m., at Given Courtyard South Level 4.   

a.       January 21, 2016:  Rodger - CDC Grant Diabetes Data Pull

b.      January 28, 2016:

c.       February 4, 2016

Recorder: Connie van Eeghen