Monday, January 21, 2013

Clinical Research Oriented Workshop (CROW) Meeting: Jan 17, 2013



Present: Abby Crocker, Kairn Kelley (by phone), Amanda Kennedy, Rodger Kessler, Ben Littenberg, Charlie MacLean, Prema Menon, Connie van Eeghen

1.                  Start Up:  News from Rodger: instructions from study section leader – all applications start with a score of 5 (middle of the range). This is the result of clustering at the low (better) end. 

2.                  Presentation: Future CROW group project
a.       In a recent CROW session, the group had agreed that it would be interesting to discuss a broad outline of a group research project with roles organized around investigator, analyst, and reviewer.  One of our goals is to learn more about multi-level modeling through a team-based research study. The ideal project will result in a publication.
b.      Possible topics:
                                                  i.      Benzos: currently topical due to an FDA announcement on Monday restricting prescription dosages for women.  High prevalence; alternative treatments are present in data bases.
                                                ii.      Stimulants for children with ADHD (short-acting vs. long-acting)
c.       Data sources:
                                                  i.      Data are available now from VHCURES without Medicare age group; may be missing many clinical co-variates (limited to what is paid for by insurance).  Submit a request to Liz and work with Liz and Steve Kappel to organize.  IRB moves quickly and Steve runs the data. Almost five years of data (started in 2007).
1.      Is the denominator patients or prescribers?  Patients will have incomplete histories based on cash payments and out-of-state services. There may be problems with unique patient identifiers, as insurance companies have different patient codes.
2.      Topics must be exclusive of geriatrics and hospital admissions.  Medications and procedures only. Does have ED visits.  Does not have zipcodes.
                                                ii.      IRIS: many more co-variates (entire clinical record); no claims from VHCURES with more extensive med list.  PRISM med list is smaller and less accurate; patients may be getting care that is invisible to IRIS.
d.      Research topic: “what is the association of x to y while controlling for z.”  We’re interested in topics that are not just driven by the main predictor but cluster by certain variables (e.g. providers).  Therefore, a larger sample size isn’t as important as the number of providers, and the sample sizes within those clusters.  This phenomenon can appear at many levels: practice, county, and within patient (for repeated events, such as cardiac care visits).  Consider picking a homogenous population to provide a good template for this type of research study and a predictor with greatest opportunity to learn about different analytical models.
                                                  i.      Motivation for Kairn, who started us down this road: each child is tested more than once, from a specific class, on a specific day of week.  Different analytical models produce different results; when to use which?
                                                ii.      Possible predictors: geography, type of practice (primary, specialty), medication (hypnotic meds [benzos] dose category, short acting opiates, babies on opiates, multi-prescriber opiates, stimulants long/short)
1.      The team is considering opiates, categorized by long/short, length of time (< and > 60 days).  Could have a systematic intervention (duration limits on short-acting Rx)
                                              iii.      Possible outcomes: ED visits, use of medications (atypicals, benzos, opiates), event related to medication, surgeries, diagnosis codes related to procedures, cost/utilization in a defined time period, fall/fractures, dose progression, persistence of drug therapy (point prevalence), drug substitution, clinical momentum (continued use of drugs on auto-pilot)
1.      The team is considering ED visits
                                              iv.      Variables to control: time (secular trends in prescribing)
                                                v.      Lines of inquiry:
1.      How much of the variation of x is explained by provider vs. patient.
2.      Comparative effectiveness
3.      Penetration of interventions
4.      Dose/response effect: benzos and ED visits
a.       Classify into high/med/low dose
b.      Adults only (age restriction)
c.       Analyze event rates for three dosage categories
5.      Natural history of drug use
                                              vi.      Next step: VHCURES code book; Steve Kappel – Connie to follow up

3.                  Next Workshop Meeting(s): Thursday, 2:00 p.m. – 3:30 p.m., at Given Courtyard Level 4. 
a.       Jan 24: Abby: breast feeding paper
b.      Jan 31: Kairn: F31 update
c.       Feb 7: Abby:
d.      Feb 14:
e.       Future agenda to consider:
                                                  i.      Christina Cruz, 3rd year FM resident with questionnaire for mild serotonin withdrawal syndrome on 12/6 or 12/13
                                                ii.      Peter Callas or other faculty on multi-level modeling

Recorder: Connie van Eeghen

Tuesday, January 15, 2013

Clinical Research Oriented Workshop (CROW) Meeting: Jan 10, 2013



Present: Kairn Kelley, Amanda Kennedy, Rodger Kessler, Ben Littenberg, Charlie MacLean, Connie van Eeghen

1.                  Start Up:  How much money is it possible to spend on a watch?  Try $4.5m, per Rodger.  There is no process that we can think of that quite explains this resource allocation.

2.                  Presentation: Kairn: F31 grant application for career development of pre-doctoral fellows: stipend, research, and tuition for 2-5 years.
a.       The FINER question is “Do symptoms of ADHD affect the reliability of dichotic word tests?”
b.      Aims: recruitment, test administration, data collection (including scoring of ADHD and treatment of children for ADHD), results, relationship between ADHD and test results.  Questions of interest:
                                                  i.      Does ADHD impair the reliability of DWT?
                                                ii.      What is the distribution of DWT scores in an unselected pop?
                                              iii.      What is the test-retest reliability of DWT in unselected pop?
                                              iv.      Do scores differ in ADHD vs. non-ADHD?
                                                v.      Does reliability differ in ADHD vs. non-ADHD.
c.       FINER:
                                                  i.      Feasibility: pending
                                                ii.      Interesting: yes
                                              iii.      Novel: yes; ensure that this study is not duplicative of another researcher known to be at work in this area of the field.
                                              iv.      Ethical: yes, but schools may not want to hear about previously undiagnosed problems, and this does place a burden on kids that may be struggling.  Also, there’s no ability to follow up medically on newly found diagnoses. 
                                                v.      Relevance: feedback from program officer indicated that this was not clear.  Identify whether there is clinical interest and develop a strong statement about:
1.      Tests need to be evaluated
2.      ADHD is an important clinical subgroup
3.      Concerns of reliability could affect patient/student outcomes
4.      Consider estimating the financial impact of administering this test across the country
d.      Design: cross-sectional sample with a follow up test
                                                  i.      Target population: general U.S. school age population, English as first language, ages 6-11, with consistent language patterns with the test and the raters.   
1.      Age as a covariate (older kids score better)
2.      Concern: Is the scope broad enough to attract reviewers/funding?  Consider seeking out collaborators in other states/territories (e.g. Puerto Rico)
                                                ii.      Sample:
1.      VT school children (non-Vermont samples will help the F31 greatly), captured in an unselected way (no differentiation by other diagnoses affecting children)
2.      Pediatric patients, pre- and post-wellness visit
                                              iii.      Measures: ADHD checklist (filled out by parent or teacher), DWT scores, demographic data
1.      Retest: logistic issues include number of days within which the test can be re-taken, preferably within 3 weeks (see Amanda’s suggestion of previous doctoral student’s experience with gaining access to schools across the country).  Retest will be the same words in same order.

3.                  Future CROW Sessions: The group agreed that it is interested in discussing a broad outline of a group research project with roles organized around investigator, analyst, and reviewer.  Access to data may determine some aspects of the project, as IRIS is not quite ready yet.  Rodger noted that another data base source is SafetyNet with Medicaid claims of FAHC and FQHC patients.  These data may not tell the complete story of a patient’s history of treatment, but other sources are also available.  Our goal is to learn more about multi-level modeling through a team-based research study.  For discussion next week. 

4.                  Next Workshop Meeting(s): Thursday, 2:00 p.m. – 3:30 p.m., at Given Courtyard Level 4. 
a.       Jan 10: Kairn: F31 grant application for career development of pre-doctoral fellows: stipend, research, and tuition for 2-5 years.  CROW: review high level plan to study and conduct research using IRIS and multi-level modeling.
b.      Jan 17: CROW research project plan
c.       Jan 24:
d.      Jan 31: Kairn: F31 update
e.       Feb 7:
f.       Future agenda to consider:
                                                  i.      Christina Cruz, 3rd year FM resident with questionnaire for mild serotonin withdrawal syndrome on 12/6 or 12/13
                                                ii.      Peter Callas or other faculty on multi-level modeling

Recorder: Connie van Eeghen

Saturday, January 12, 2013

PhenX

PhenX is a project to define standard phenotypic descriptor variables to be used with genome studies. It has consensus-chosen instruments for demographics, antropometrics, alcohol and substance use, diseases, symptoms, and so on. Each one is scripted, referenced and cataloged pretty carefully.  Even if you are not doing genome studies, it could be a good sources of instruments and variables.

https://www.phenxtoolkit.org/index.php

Wednesday, January 9, 2013

Clinical Research Oriented Workshop (CROW) Meeting: Jan 3, 2013



Present: Kairn Kelley (by phone), Amanda Kennedy, Rodger Kessler, Charlie MacLean, Connie van Eeghen

1.                  Start Up:  Amanda is all healthy and Ben is not.  Connie has the new, in vogue “intermittent asthma” and Rodger does not.  Winter in Vermont (not to be confused with Autumn in NY).

2.                  Presentation: Connie shared her draft abstract for a presentation to the Society for General Internal Medicine, which has a theme of leadership, especially the development of emerging leaders within generalism.  Connie presented her abstract as a scientific submission, which requires reporting of final results but has more opportunities for poster or presentation than the Clinical Practice Innovation call for abstracts, which does not require reported results.  Connie wanted to know if the abstract was strong enough for a scientific submission and some practical advice on how to strengthen and categorize it.
a.       Starting with the conclusion of the group, all present agreed that the abstract was strong enough for a Scientific Submission.  Out of the 14 categories available for submission, Organization of Care and Chronic Disease Management was considered the best choice. 
b.      Remove detailed explanations and examples.  No room for this with the character count limits.
c.       Decide which is most important: the strategy of QI (the Lean approach) or the 14 strategies for managing opiate prescriptions (the purpose of using the Lean approach).  The abstract (and reader) need to focus on one of these.  This lead to a helpful discussion about what Connie wants to study (the former) and what the audience thinks it wants to hear about (the latter).  Can she do both?  Yes, implicitly, but the abstract still has to be about ONE study question.  In other words, if you’re going to try to have your cake and eat it too, don’t tell anyone.
d.      Once the primary research question is established, identify the method and stick with it.  There’s not enough quantitative data for a quantitative study (for this group); there’s lots of rich data for a qualitative study.  Go with your strength. 
e.       This abstract will be competing with much stronger quantitative studies.  There may be an advantage to just being different, especially if it’s a relevant and novel study.  It’s a gamble, but a worthwhile one.
f.       Many thanks to all; very helpful input.  (Abstract successfully submitted on Jan 9.  Thank you Charlie, for getting it in.)

3.                  Future CROW Sessions: Kairn proposed that we learn more about multi-level modeling through a presentation (e.g. Peter Callas).  Amanda further proposed that we select a research study on which to practice multi-level modeling, and get a research paper out of it.  One possibility is the epidemiology of benzodiazepines, which Amanda and Charlie might be interested in studying through the use of IRIS. 
a.       Kairn and Connie will meet to begin development of a study plan
b.      Rodger will send recommendations for guests/projects as they become available.  He will also review the Brownson text on Dissemination and Implementation for worthwhile chapters to read together.
c.       Journal articles for review are always welcome.
d.      Discussion with Ben: will there be more grants like the R24 to work on as a team?  Or will the new research director provide that opportunity?

4.                  Next Workshop Meeting(s): Thursday, 2:00 p.m. – 3:30 p.m., at Given Courtyard Level 4. 
a.       Jan 10: Kairn: F31 grant application for career development of pre-doctoral fellows: stipend, research, and tuition for 2-5 years.  CROW: review high level plan to study and conduct research using IRIS and multi-level modeling.
b.      Jan 17:
c.       Jan 24:
d.      Jan 31:
e.       Future agenda to consider:
                                                  i.      Christina Cruz, 3rd year FM resident with questionnaire for mild serotonin withdrawal syndrome on 12/6 or 12/13
                                                ii.      Peter Callas or other faculty on multi-level modeling

Recorder: Connie van Eeghen

Tuesday, January 8, 2013

Writer's Almanac Today

The poem read on today's Writer's Almanac, originally published in JAMA last year, made me think of the work we do in CTS. I share it for your reflection:

Myth Dispelled

The flu vaccine cannot
give you the flu, I tell him.
It's dead virus, there's
nothing alive about it.
It can't make you sick.
That's a myth.
But if we bury it in
the grassy knoll
of your shoulder,
an inch under the stratum
corneum, as sanctioned by
your signature
in a white-coated ceremony
presided over by
my medical assistant
and then mark the grave
with a temporary
non-stick headstone,
the trivalent spirit
of that vaccine
has a 70 to 90 percent
chance of warding off
the Evil One,
and that's the God's
honest truth

"Myth Dispelled" by Adam Possner, from JAMA, December 5, 2012. © American Medical Association, 2012