Clinical Research Oriented Workshop (CROW) Meeting: Dec 6, 2012

Present: Kairn Kelley, Rodger Kessler, Ben Littenberg, Prema Menon, Connie van Eeghen

1.                  Start Up:  Inter-rater Reliability article update. Box and whisker plot is successful to show differences in inter-rater reliability over time (over the study period and over the ordinal placement of the subject on each day of testing)

2.                  Presentation: Kairn: F31 grant application for career development of pre-doctoral fellows: stipend, research, and tuition for 2-5 years. Goal: to structure and fund dissertation

a.       Domain (as written in May):

                                                  i.      “What role could dichotic listening testing play in the assessment of children with ADHD?”

                                                ii.      The definition of ADHD includes two subgroups (inattention and hyperactive)

b.      Plan (from May)

                                                  i.      Lit review

                                                ii.      Select tests [deliverable paper on available tests]

                                              iii.      Subjects (define population)

                                              iv.      Test each subject twice

                                                v.      Analyze

c.       Aims (from May):

                                                  i.      ADHD-PI score differently than ADHD-C

                                                ii.      ADHD score differently than normal

d.      Lit Review Thus far reveals some opportunities:

                                                  i.       need for basic epidemiologic studies of APD test performance

                                                ii.      There is an association between the two diagnoses: ADHD (diagnosed by set of symptoms) vs. APD (auditory processing disorder, diagnosed by a set of test results)

e.       Discussion:

                                                  i.      Consider an epidemiologic question: what is the distribution in a population of children for the prevalence of APD and ADHD.

1.      Aim 1: mean and std dev for dichotic test

2.      Aim 2: correlation between APD and ADHD

3.      Aim 3: percent overlap

4.      Aim 4: how much does one test identify the other result

5.      Aim 5: does the remedy for ADHD have an effect on APD

                                                ii.      Consider a study in an “enriched population” of children who are likely to have ADHD and are likely to have APD: “Is dichotic testing a good test of ADHD?”

                                              iii.      Measure stability of scores as a phase 1 study:

1.      How stable is the test?

2.      Is APD a trait or a state?

3.      Is the measure stable?

4.      Is the score associated with ADHD?

5.      Is instability in the score associated with ADHD?

6.      What does the normal population look like?”

7.      How long a period of time should elapse to retest in a child?

8.      Should the study include a combination of words that are presented to both ears (cat/dog and also dog/cat)?

9.      Does the data that were collected in the pre-test show that the first 25 word combinations result in the same scores as the last 25 word combinations?

10.  Test in the “normal” population, ADHD population, and APD population to test the difference. 

f.       Call the project officer about details related to the application, e.g. does the sponsor need to have a current R01 grant?

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

a.       Dec 13: Prema: draft grant application. (No Ben)

b.      Dec 20: Winter break – next meeting is on January 3, 2:00 – 3:30.    

c.       Future agenda to consider:

                                                  i.      Ben: budgeting exercise for grant applications; NHANES – lower female mortality for women taking birth control medications

                                                ii.      Rodger: Mixed methods article; article on Behavior’s Influence on Medical Conditions (unpublished); drug company funding.  Also: discuss design for PCBH clinical and cost research.  Also: Prezi demo. 

                                              iii.      Amanda: presentation and interpretation of data in articles

                                              iv.      Christina Cruz, 3^rd year FM resident with questionnaire for mild serotonin withdrawal syndrome on 12/6 or 12/13

Recorder: Connie van Eeghen and Kairn Kelley

Clinical Research Oriented Workshop (CROW) Meeting: Nov 29, 2012

1.                  Start Up:  How to engage surgical students in research – timing is everything.

2.                  Presentation: Prema’s hypothesis and specific aims of her 15 page, career development grant.  This is the second application to a palliative care private foundation.  Comments:

a.       Explain the acuity of this population of ICU patients.  They are sicker for a reason.

b.      This is your “sell sheet.”  The goal is to help people make decisions.  Explain the vulnerability of these patients and why we care.

c.       Start with the connection to palliative care (and reducing avoidable transfers - paragraph 1), and then move to informed decision making (paragraph 2), with telemedicine following (paragraph 3).  Aim 2 can break into subheadings for quantitative and qualitative measures of family satisfaction, the quality of communication/care, and outcome scores. 

d.      Use consistent language across aims: create, pilot test with quantitative and qualitative outcomes.

e.       The specific aims and methods should be planned to set up the future RCT study that Prema wants to conduct next.  One option: the referral centers (like Malone and Alice Hyde) could be the location where patients are randomized to either “teleconference and transfer” or “transfer” groups.  Another option: pre/post at the tertiary institution level, to avoid contaminating participants with a new (better) way of conducting the conference, which happens anyway. 

f.       This led to an interesting finding that Prema shared: the suggestion of a conference, made by the ICU MD to the referring MD, causes a conference to happen with the family off-line that results in fewer transfers to the ICU.  There is already evidence that participants are contaminated by being asked to talk to the family in order to set up a teleconference.  The long term cost of contamination is that follow up studies get harder to set up.

g.      Another option: the experimental group is Prema and 2 other intensivist’s patients; the control group is the other 13 intensivists.  There is a risk of under powering the study, as the three experimental MD’s may be unusually effective in conducting this intervention. 

h.      There is a delicate balance between alluding to key issues (like costs) for long term interests and staying focused on the key measure for this study. 

i.        There are around 300 transfers/year, and growing to almost 400. 

j.        This is an intervention with a comparison based on convenience.  Subjects are family members clustered by the provider. The intervention is the telemedicine family conference.  Study type: an experimental, prospective study with convenience assignment.  Because the goal is to create enough data to power a larger study, it might be more efficient to run only the experimental arm, and compare the results to the results reported in the literature.  Prema will re-examine the literature.  This will also keep the application focused on career development, rather than focusing solely on the research. 

k.      Clarify that the patient group of interest is not those that are transferring, but considering transfer. 

l.        Consider Annette O’Connor’s decisional conflict scale: from decision aid literature – conflict of the decision and satisfaction with the result.  Dates back to 1990s. 

m.    Consider a future grant to “train the colleague” in other ICU’s, like the Vermont Oxford approach, to help other intensivists run their own studies.  Start your own PBRN!

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

a.       Dec 6: Kairn: TBD

b.      Dec 13: Prema: draft grant application.

c.       Dec 20: Winter break – next meeting is in January

d.      Next semester: move to 1:30 – 3:00 instead of 2:00 – 3:30?  Connie will check with Rodger and Abby. 

e.       Future agenda to consider:

                                                  i.      Ben: budgeting exercise for grant applications; NHANES – lower female mortality for women taking birth control medications

                                                ii.      Rodger: Mixed methods article; article on Behavior’s Influence on Medical Conditions (unpublished); drug company funding.  Also: discuss design for PCBH clinical and cost research.  Also: Prezi demo. 

                                              iii.      Amanda: presentation and interpretation of data in articles

                                              iv.      Christina Cruz, 3^rd year FM resident with questionnaire for mild serotonin withdrawal syndrome on 12/6 or 12/13

Recorder: Connie van Eeghen

Clinical Research Oriented Workshop (CROW) Meeting: Nov 1, 2012

Present: Kairn Kelley, Ben Littenberg, Charlie MacLean, Prema Menon, Connie van Eeghen

1.                  Start Up: Post Sandy-Hurricane – at least it’s not raining.

2.                  Presentation: Kairn: final draft of article on IRR titled: “Inter-rater reliability for scoring dichotic words test responses of 6-10 year-old children.”  The group reviewed the draft and made the following comments/suggestions:

a.       Target journal: American Speech-Language-Hearing Association journal (American Journal of Audiology) or Journal of the American Academy of Audiology. Content of journal is consistent with this draft. Add more explanation re: why a logistic regression was used (Bonferroni correction details irrelevant after change to analysis discussed later; Bonferroni adjusts for likelihood of statistical significance occurring by chance from multiple comparisons)

b.      State sooner that the test’s word list is novel, although the test concept is well-established.  Consider saying more about why this new word list was developed.

c.       Abstract states IRR improves over time, but this doesn’t explain the duration involved.  These were naïve raters for this word list; worth saying up front.

d.      A detailed discussion on the two alternative figures ensured, which was so engaging that the recorder forgot to take notes.  Decision: any words outside the 95% confidence interval should be considered for exclusion from the word list.

e.       Consider doing a clustered analysis, as there is randomness among words and randomness among children. 

f.       Logistical regression results: keep the details that show change by session, which was the significant variable in explaining change in rater performance.  Include age, sex, and hearing in the data table.  Experiment with a figure, showing the change in session over time (possibly a series of box plots).

g.      Methods decision to use percent agreement might be the place to explain why Kappa was not used.  Or a sentence, in discussion, as a strength, rather than in the Limitations section.

h.      Recheck the language for the section marked: Test Item Difficulty/Pass Proportion

i.        Ben has the best tongue twisters in the group, but Charlie came up with some good ones too.

j.        Next: redraft – and think about how to do this for ADHD children.

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

a.       Nov 8: Rodger & Connie: presentation on Strategies on Implementing BHI

b.      Nov 15: Abby: review of draft manuscript for NAS predictors article (no Ben)

c.       Nov 22: THANKSGIVING… take the day off J

d.      Nov 29: Prema: draft grant application

e.       Dec 6:

f.       Future agenda to consider:

                                                  i.      Kairn – review of draft article on IRR  

                                                ii.      Ben: budgeting exercise for grant applications; NHANES – lower female mortality for women taking birth control medications

                                              iii.      Rodger: Mixed methods article; article on Behavior’s Influence on Medical Conditions (unpublished); drug company funding.  Also: discuss design for PCBH clinical and cost research.  Also: Prezi demo. 

                                              iv.      Amanda: presentation and interpretation of data in articles

                                                v.      Christina Cruz, 3^rd year FM resident with questionnaire for mild serotonin withdrawal syndrome on 12/6 or 12/13

Recorder: Connie van Eeghen and Kairn Kelley