Clinical Research Oriented Workshop (CROW) Meeting: April 11, 2013

Present:  Abby Crocker, Kairn Kelley, Amanda Kennedy, Rodger Kessler, Connie van Eeghen

1.                  Start Up: Amanda provided a brief overview of her testimony this morning, invited by Commissioner Chen, at the Statehouse on a proposed amendment to the H391 bill, which funds Academic Detailing and Blueprint Pharmacists through a fee placed on insurance companies.  The bill (which supports prescriber education) is being discussed for amendment: one of the reps proposes including “consumer education” into the bill, increasing the fee from $0.50 to $0.75 per claim.  Amanda talked about the experience, both the formal testimony and the informal conversations.  Bottom line: it’s all about relationships.

2.                  Presentation: NAPCRG Abstracts – Review of 4

a.       Amanda: Integrating pharmacists, in which the key question was how to highlight the data in support of the innovations around population management through practice-based pharmacists, particularly regarding the degree to which costs were affected and prescriber behavior was changed.

b.      Connie: Opioid prescription management interventions: much editing to tighten and streamline.

c.       Rodger: Pre-conference workshop proposal on RE-AIM, in which the key question was focused on the makeup of the audience (grant-writing scientists and evaluation-focused front line clinicians).  One of the underlying goals is to test the usefulness of the study development function of the website.  Participants may be more interested in interaction with the workshop presenters than with the website.  (We also wondered if is there a theme to the NAPCRG annual conference; a review of the conference website by Connie afterwards provided no clue.)

d.      Charlie: Population reporting of opioid prescribing: clear and concise; minor editing suggestions only.

e.       Abby: submit an abstract from the predictor paper for NAPCRG!

3.                  Next Workshop Meeting(s): Thursday, 2:00 p.m. – 3:30 p.m., at Given Courtyard South Level 4. 

a.       April 18: Kairn: Inter-Rater Reliability final draft (as a separate note, Ben, Rodger, Abby, & Charlie meet at a different time this day to discuss analytical plan for NHoAOU)

b.      April 25: Rodger: TBD (no Connie, Kairn, or Amanda)

c.       May 2: (no Connie, Charlie)

d.      May 9: Charlie: Exploration of analytical plan for Natural History of Acute Opiate Use (and perhaps more).  Everyone should first read the 2009 Boudreau article that Amanda found in her lit review, circulated on April 2.

e.       May 16:

f.       May 23:

g.      May 30:  

h.      Future agenda to consider:

                                                  i.      Christina Cruz, 3^rd 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

Worth taking a minute or two to check out...

This a voyage that makes websites sort of worthwhile...  Scale of the Universe

Clinical Research Oriented Workshop (CROW) Meeting: March 28, 2013

Present:  Abby Crocker, Kairn Kelley, Rodger Kessler, Charlie MacLean, Connie van Eeghen

1.                  Start Up: This was a relaxed, pre-presentation for organization and strategy planning.  No secrets were exposed in this session, so feel free to read on!

2.                  Presentation: Abby: Dissertation Defense Draft in HSRF 300

a.       The organization of this presentation follows, but is not limited to, the work done to produce three final articles that are the deliverables of Abby’s doctoral work:

                                                  i.      Introduction (population and epidemiology)

                                                ii.      Objectives

                                              iii.      What Neonatal Abstinence Syndrome (NAS) is and how to diagnose it.  This includes review of scoring tools, two of which are used most commonly, and the four approaches to assessing diagnostic tools:

1.      Biologic plausibility

2.      Technical feasibility

3.      Diagnostic accuracy

4.      Clinical impact

                                              iv.      Predictive models for NAS, with interesting findings related to mother’s exposure to methadone, infant head circumference, and APGAR (these last two variables are new findings to add to the literature)

                                                v.      Policy related to breastfeeding, barriers and effect on NAS, implications for policy

                                              vi.      Next steps and future directions

b.      The discussion developed into the identification of the underlying story line: how all these pieces help providers, researchers, and policy makers understand how to help babies and their mothers together.  Abby has identified:

                                                  i.      Why NAS is a serious problem that is hard to diagnose, which leads to why we need to be better at predicting its occurrence

                                                ii.      How the typical population of NAS infants and their mothers (high risk, post-birth issues, parenting issues) can be helped as part of a broader public health goal, including specific factors that policy can have impact on

c.       Presentation tips and techniques were reviewed for the benefit of the viewing audience.  Group consensus: Abby is ready for take-off and will have a great dissertation defense.

3.                  Next Workshop Meeting(s): Thursday, 2:00 p.m. – 3:30 p.m., at Given Courtyard South Level 4. 

a.       April 4: Kairn: F31 Final (Ben & Amanda will be at Abby’s dissertation defense; probably Abby too)

b.      April 11: Amanda, Ben, Charlie, Connie and anyone else with a NAPCRG abstract underway (Abby?) the annual in Ottawa this November: bring your 300 word abstract draft to pass around and review with the group (deadline is six days later: April 17)

c.       April 18: (Ben, Rodger, Abby, & Charlie meet at a different time this day to discuss analytical plan for NHoAOU)

d.      April 25:

e.       May 2:

f.       May 9: Charlie: Exploration of analytical plan for Natural History of Acute Opiate Use (and perhaps more).  Everyone should first read the 2009 Boudreau article that Amanda found in her lit review, circulated on April 2. 

g.      Future agenda to consider:

                                                  i.      Christina Cruz, 3^rd 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

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, 3^rd 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