Tuesday, March 26, 2013

Clinical Research Oriented Workshop (CROW) Meeting: March 21, 2013

Present:  Marianne Burke, Abby Crocker, Kairn Kelley, Amanda Kennedy, Ben Littenberg, Connie van Eeghen
Guest:     Molly Schmidt
1.                  Start Up: Mollie Schmidt has a PhD in School Psychology and is certified in Clinical Psychology.  She is visiting from Rome, Maine and trying to figure out what an Assistant Professor does with all her time (that would be her daughter, Connie).  She was warmly welcomed.

2.                  Presentation: Kairn Kelley – F31
a.       Kairn has a goal of submitting her F31 proposal in April, and has her foot hard on the accelerator.   She shared the significance and specific aims.  She wants feedback on whether her story makes sense and what measures she should use to capture her results.
                                                  i.      The reason for the study is well-defined: the problem is common, morbid, and treatable but the diagnostic tests are not well-supported.  The issue Kairn is addressing the diagnostic value of the tests and which tests to use, and how to evaluate the results.
                                                ii.      Set the stage: we don’t know these tests, even at the level of dichotic and non-dichotic tests.
                                              iii.      The message, which has to be readable by looking at the first sentence of each paragraph, is something like: “The tests are mysterious, we’ll fix the tests, and patient care will be better.”  Use subheadings to lead the reader through the story: Scope of the Problem (what do you want to fix), Tools (how to diagnose the condition is based on tests not subjected to rigorous evaluation of the psychometric properties (or text characteristics or reliability) to date.  Dichotic tests (describe) in particular, have not been well…
                                              iv.      In addition, the Overview section needs to be shorter and less dense, even though the advice is also to add more detail.  (Good luck with this.)
b.      Audience: Institute on Deafness and Hearing Disorders, with a high proportion of applications accepted.  The study section is unique to F proposals; it is helpful to identify them to help plan how to write the story.  Know what their priorities are in research and be ready to focus definitions on their likely level of understanding.  Study section titles include: Brain Disorders and Language Communications; Behavioral Neuroscience; Sensory Motor Science Cognition and Perception; and Neuro-Degeneration.  Be clear about what you are going to accomplish. 
                                                  i.      The study section for Brain Disorders includes radiologists, critical care specialists, psychologists, neurologists, pharmacologist… no audiologists.
                                                ii.      Sensory motor science: has fMRI studies; list is not available.
                                              iii.      Contact the Project Officer – find out if these are the right study sections and if one can request a study section.
c.       Specific Aims: this is the most commonly read page across the entire study section.
                                                  i.      Should it include the training and mentoring plan?  Per the Project Officer, everything should demonstrate how it fits into your training plan with the result that you will be an “independent, successful investigator and author of RO1s”
                                                ii.      Look at previous F applications (narratives and aims).  Gabe’s was strictly focused on the research study, not the training plan.  Consider stating the broad goal: lay the foundation of diagnostic testing and improve accuracy.  Specifically for this project, the focus is test/retest reliability.  We will achieve this by meeting the following specific aims…
                                              iii.      Start the story here: children are being harmed due to lack of accurate testing and follow up.  Consider using the “Objectives” as the Aims statement; move the specificity of the Aims to the Approach section.  Create an elevator speech with the four essential sentences: relevance, question, action, future.
                                              iv.      The third Aim is expressed as a hypothesis test; do this formally with an H0 and a null.  Otherwise, remove the language.  If so, use “compare” or “evaluate” and avoid being boxed into an assumption of the reader’s.  Leave “registry” for the future work planned or deliverables.
d.      Measures:
                                                  i.      Subjects: originally 7-10 yr. old, due to guidelines (for <7) and consent requirements (>10). Recommendation: go as high as clinically relevant to improve power calculations (up to 14 yrs.).  Training effectiveness is highest from 7-12.  Check clinical guidelines. 
                                                ii.      Inclusion: clinical practice guideline eligibility and other subject characteristics.  Parents will be asked if children have received special services but these children will be included. 
                                              iii.      Exclude: febrile, coughing, otitis media, and other acute problems (pain, rash,…).  IQ is not an exclusion criteria
                                              iv.      Goal: 125 complete analyzable cases
e.       Limitations: one practice, one location; clinical relevance required small, focused sample; conducted under field conditions.
f.       Good luck!  Not that Kairn will need luck, but at least may Good Fortune go with all emerging PhD students – and this would include Abby and her upcoming dissertation defense (see below).

3.                  Next Workshop Meeting(s): Thursday, 2:00 p.m. – 3:30 p.m., at Given Courtyard South Level 4. 
a.       Mar 28: Abby: Dissertation Defense Dry Run (will start at 2p, on schedule – new location?) in HSRF 300
b.      April 4:
c.       April 11:
d.      April 18:
e.       April 25:
f.       May 2:
g.      May 9: Charlie: Exploration of analytical plan for Natural History of Acute Opiate Use (and perhaps more)
h.      Future agenda to consider:
                                                  i.      Christina Cruz, 3rd year FM resident with questionnaire for mild serotonin withdrawal syndrome?
                                                ii.      Peter Callas or other faculty on multi-level modeling
                                              iii.      Charlie MacLean: demonstration of Tableau
                                              iv.      Journal article: Gomes, 2013, Opioid Dose and MVA in Canada (Charlie)

Recorder: Connie van Eeghen

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