Clinical Research Oriented Workshop (CROW) Meeting: January 26, 2012

Present: Abby Crocker, Kairn Kelley, Rodger Kessler, Ben Littenberg, Charlie MacLean

1. Start Up: Follow up on Kairn’s meeting with Ben: how the use of behavioral tests with a learning effect (e.g., subjects perform better on re-test) could be managed. The use of a control group an option for treatment studies, but larger numbers are required to achieve adequate power. A protocol that includes enough repeat testing so subjects reach a plateau is another option. We expanded on this idea, that is essentially a modification of the concept of the control chart applied to questions where variable behavioral test scores are an outcome.

2. Presentation: Abby provided an update on her research questions and proposed outputs:

a. Her research questions in outline form:

i. What is neonatal abstinence syndrome?

ii. What are the early predictors (collected up to 5 min post delivery) of NAS

iii. Are opiate exposed newborns treated for NAS less likely to be breastfed? (interested in policy implications of breastfeeding in this high-risk group)

b. Associated deliverables:

i. Publishable lit review

ii. Manuscript of primary analysis

iii. Policy paper (perhaps aimed at Journal of Health Affairs)

iv. Policy experience

c. Although she's been moving forward on each deliverable, she's now aiming to finish #1 (a lit review on the question "what is neonatal abstinence syndrome?"). There was discussion about the distinctions between literature review, systematic review, meta analysis, and meta analysis of RCTs. Summary: definitions come first, make them clear and relevant (What do you mean by NAS? Identify papers that look at THAT) make the lit review serve your research questions

3. Workshop Goals for 2012:

a. Journal club: identify UVM guests and articles; invite to CROW ahead of time

b. Research updates: share work-in-process

4. Next Workshop Meeting(s): Thursday, 1:00 p.m. – 2:30 p.m., at Given Courtyard Level 4.

a. Feb 2: Amanda: update on pharmacists integrated into primary care practices as part
of a VDH-funded grant Meeting ends at 2:00 – one hour only.

b. Feb 9: (no Ben, Amanda)

c. Feb 16: (no Connie, No Kairn)

d. Feb 23: Connie: oral presentation for defense (no Amanda)

e. Mar 1: (no Connie, ? Kairn)

f. Mar 8: Early start, for those available, 11:00 – 2:00, Connie’s dissertation defense

g. Mar 15: (no Ben, Connie)

h. Future agenda to consider:

i. Ben: budgeting exercise for grant applications

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.

iii. Amanda: presentation and interpretation of data in articles

iv. Sharon Henry: article by Cleland, Thoracic Spine Manipulation, Physical Therapy 2007

v. Future: Review of different types of journal articles (lit review, case study, original article, letter to editor…), when each is appropriate, tips on planning/writing (Abby)

Recorder: K. Kelley

Clinical Research Oriented Workshop (CROW) Meeting: January 12, 2012

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

1. Start Up: Connie has a defense date: March 8, 2012 from 11:00 – 2:00. All are invited so please hold the date/time. We decided to convert that CROW session to “help make Connie even more nervous” day; look for details on how to “sign on” coming to you next month.

2. Presentation: Kairn is spending the semester conducting her literature review and drafting an article for publication based on her previously collected data. Her academic goals are a well defined research question and completed comps. Current lit review focus: comparison of commercially available tools to test children for auditory processing. Goal for the paper: the available tests and their strengths and weaknesses aimed at clinical audiologist audience. The group reviewed the “Development and Evidence of Reliability and Validity” chapter from SCAN-3, specifically asking “What do we know about the reliability of the competing words-free recall test?" (pages 66-67).

a. This document was a comparison of 10 auditory tests, some old, some new.

b. Tested Dec 2007, 156 adolescents, 12-15 years of age plus 34 ADP adolescents, 12-15 yrs

c. Measures: reliability (and precision and validity, eventually), as well as ease of directions for tester/testee, test means. Means and standard dev reported by test, age, and sample size

d. Reliability: accuracy, consistency, and stability of test scores across situations

i. Test-Retest stability: 48 children tested twice

ii. Table 5.7 – is this a test of mean differences. What makes these scores “adequate?”

1. Retest scores are higher

2. Stability is “excellent” based on some arbitrary cut points – Table 5.8

3. Table 5.9: Internal consistency – hard to follow

e. Start with domains (what the tests are expected to measure, such as “listening with competing signals”), not with position papers or tests, to organize the comparisons in the article. What are the evaluation parameters for judging these outcomes?

f. Next steps: review the position papers, identify domains and how discussed among position papers.

g. The ultimate goal is to define the disorder in a way that health care providers can be helpful. A maxim to help us all from Connie’s current dissertation efforts: “Research is less about getting at the truth than it is about reaching meaningful conclusions, deeper understanding, and useful results,” Trochim, (2001) Research Methods: The Concise Knowledge Base,1^st edition. Cincinnati, OH: Atomic Dog Publishing.

3. Workshop Goals for 2012:

a. Journal club: identify UVM guests and articles; invite to CROW ahead of time

b. Research updates: share work-in-process

4. Next Workshop Meeting(s): Thursday, 1:00 p.m. – 2:30 p.m., at Given Courtyard Level 4.

a. Jan 19: Chris Jones and Rodger’s article on QALI’s (no Connie, no Kairn)

b. Jan 26: Abby update and article to review (no Amanda, no Connie)

c. Feb 2: Rodger: discuss design for PCBH clinical and cost research. Meeting ends at 2:00 – one hour only? Or start early at 12:30? To be discussed at next session.

d. Feb 9: (no Ben, Amanda)

e. Feb 16: (no Connie, No Kairn)

f. Feb 23: Connie: oral presentation for defense (no Amanda)

g. Mar 1: (no Connie, ? Kairn)

h. Mar 8: Early start, for those available, 11:00 – 2:00, Connie’s dissertation defense

i. Mar 15: (no Ben, Connie)

j. Future agenda to consider:

i. Ben: budgeting exercise for grant applications

ii. Rodger: Mixed methods article; article on Behavior’s Influence on Medical Conditions (unpublished); drug company funding

iii. Amanda: presentation and interpretation of data in articles

iv. Sharon Henry: article by Cleland, Thoracic Spine Manipulation, Physical Therapy 2007

v. Future: Review of different types of journal articles (lit review, case study, original article, letter to editor…), when each is appropriate, tips on planning/writing (Abby)

Recorder: C. van Eeghen

Clinical Research Oriented Workshop (CROW) Meeting: January 5, 2012

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

1. Start Up: Jazz at the Spot on Friday night in Burlington, Shelburne Rd.

2. Journal Club: Bronfort, Spinal Manipulation Ann Intern Med, 2012 – focus: methods review. One guideline available for reporting studies is found on the CTS website: CONSORT, which provides a “gold standard” checklist for reporting, not for running a clinical study. (See Ben’s post below under “Research Reporting Guidelines” for more info on this.) This particular article followed most of the checklist items. The Annals requires this as a standard for publishing.

a. Researchers: DC is a Doctor of Chiropractic. Authors come from the center for clinical studies at NW Health Sciences U in MN, a pain management clinic in MN, an unaffiliated stats/data specialist, health policy and clinical effectiveness division of Cinci Children’s Hospital OH, and a center for outcomes and clinical research in MN

b. Problem stated: treatment of mechanical neck pain (acute and subacute) has little research guidance

c. Objective: measure relative efficacy (ability of an intervention to produce the desired beneficial effect in expert hands and under ideal circumstances) of SMT, Rx, and HEA in short and long term (multiple periods from 2 to 52 weeks)

d. Design: RCT

i. Randomization: what is “permutated blocks of different sizes?” p. 2

1. Block randomization is a method of distributing patients randomly in “blocks” of 3, 6, 9… so that the clinician can’t predict which arm the “next” participant will be in.

2. Participants were not blinded but could have been. The study asks which is the most efficacious treatment, without the participants’ choosing. Informed participants who could choose and were blinded to whether they received their chosen treatment would have answered a different question. Blinded participants would have provided more basis for choosing in the real world.

3. Interventions were not equivalent: SMT brings with it a lot of individual attention.

4. No stratification by sex or age or baseline pain measure.

ii. Goal was 270 participants; 272 entered study; needed 229 for power calc

1. Lost 6 in med arm immediately; wound up with 219 p. 6

2. More women wound up in med group; other differences in distribution

e. Measures: reported pain; secondarily reported disability, global improvement, med use, satisfaction, health status (SF36), adverse events. Evaluation of neck motion blinded (global improvement).

f. Results: SMT>med; HEA>meds but took longer-and not stat sig. p. 5. SMT=HEA for pain.

i. This is an issue of “multiple comparisons.” The study finds an apparent logical contradiction: SMT>med and SMT=HEA but HEA=med?

1. Data will regress to the mean: if the study starts with high pain, pain will go down just because it changes over time and the study starts at “high”

2. This clinical issue self-resolves.

3. Involvement in a study produces a success, by itself.

ii. What is “linear mixed-model analysis with the MIXED procedure in SAS?” p.3

1. It appears to assess the effect of missing data on the overall results by imputing patterns related to those lost to follow-up. Based on Intention-to-treat principle to include all participants in baseline data in the analyses, regardless of loss to follow-up.

iii. Analysis: Fisher (protected) least-significant-difference test

1. Run the ANOVA on the three arms together to determine if one group is more different than the other two

2. If yes, look for all possible correlations using Fisher

3. Currently discredited; better alternatives exist. Therefore, p values are less believable.

iv. Interpretation of the magnitude of group differences was facilitated by “responder analyses” conducted by group “for pain reduction (absolute risk reduction) of 50%, 75%, and 100% (including 95% CIs) at the end of treatment” and two additional times, This analysis helps assure that pain scores are relatively similarl. Good for helping future patients make a decision.

g. Funding: NIH-National Center for Complementary and Alternative Medicine

h. Summary: excellent report. Questionable clinical relevance or use.

3. Workshop Goals for 2012:

a. Journal club: identify UVM guests and articles; invite to CROW ahead of time

b. Research updates: share work-in-process

4. Next Workshop Meeting(s): Thursday, 1:00 p.m. – 2:30 p.m., at Given Courtyard Level 4.

a. Jan 12: Kairn – review of “Development and Evidence of Reliability and Validity” chapter from SCAN-3 (no Ben)

b. Jan 19: Chris Jones and Rodger’s article on QALI’s (no Connie)

c. Jan 26: (no Amanda)

d. Feb 2: Rodger: discuss design for PCBH clinical and cost research

e. Feb 9: (no Ben, Amanda)

f. Feb 16: (no Connie)

g. Feb 23:

h. Mar 1: (no Connie)

i. Mar 8:

j. Mar 15: (no Ben, Connie)

k. Future agenda to consider:

i. Ben: budgeting exercise for grant applications

ii. Rodger: Mixed methods article; article on Behavior’s Influence on Medical Conditions (unpublished); drug company funding

iii. Amanda: presentation and interpretation of data in articles

iv. Sharon Henry: article by Cleland, Thoracic Spine Manipulation, Physical Therapy 2007

v. Future: Review of different types of journal articles (lit review, case study, original article, letter to editor…), when each is appropriate, tips on planning/writing (Abby)

Recorder: C. van Eeghen

NSF 12-512 Smart Health and Wellbeing Solicitation FY2012

The National Science Foundation Smart Health and Wellbeing Program invites you to attend a webinar regarding NSF 12-512 Smart Health and Wellbeing Solicitation FY2012. http://www.nsf.gov/pubs/2012/nsf12512/nsf12512.htm The Smart Health and Wellbeing (SHB) Program is an NSF initiative to leverage the basic science research typically funded by the National Science Foundation in engineering, information and communication technology, and behavioral sciences towards improving the nation?s health and wellbeing. SHB seeks proposals anticipating scientific advances that would support the transformation of healthcare from reactive and hospital-centered to preventive, proactive, evidence-based, person-centered and focused on well-being rather than disease. In the past fiscal year the program was advanced from a cross-cutting initiative within CISE to an inter-directorate program of CISE, SBE, and ENG. This webinar is designed to describe the goals and focus of the current solicitation, answer questions about the program, and help investigators understand what constitutes an appropriate proposal for this initiative. ? The Webinar will be held from 2:00-3:00pm on January 11, 2012 and will consist of an informal discussion of the program followed by a longer period of Q&A. Questions can be submitted in advance or during the webinar using the email iis-shb-corr@nsf.gov. The link for participation on January 11 will be posted on the program website by January 9, 2012: http://www.nsf.gov/funding/pgm_summ.jsp?pims_id=504739&org=&from_org=NSF Reminder: Full Proposal Deadline(s) (due by 5 p.m. proposer's local time): February 06, 2012 Type I: Exploratory Projects (EXP) February 21, 2012 Type II: Integrative Projects (INT) Additional questions about the solicitation or the webinar can be addressed to iis-shb-corr@nsf.gov. Thank you for your interest and good luck in your scientific work, The Smart Health and Wellbeing Working Group National Science Foundation

Chateaubriand Science fellowship 2012-2013

Dear colleague,

I wish to inform you about the Chateaubriand Science fellowship 2012-2013, which may interest colleagues in your graduate school who have collaborations with French teams, or wish to initiate one.

The Chateaubriand scholarship program, organized by the Office of Science and Technology of the Embassy of France in Washington, is intended to finance the stay in France of American PhD students for a period ranging from 4 to 10 months, as part of a cooperation, and possibly a joint supervision ("cotutelle") leading to a dual PhD diploma.
Please find below, a message that you could forward to anyone who may be concerned.

I remain at your disposal for any further information.
Sincerely yours.
-------------------------------
Annick Suzor-Weiner, PhD
Counselor for Science and Technology
Embassy of France
4101 Reservoir Road, NW
Washington, DC 20007

Deputy Attaché for Scientific Academic Cooperation
Office of Science and Technology - Embassy of France in Washington

Land: 202-944-6252
Cell: 202-590-1025

universites.vi@ambascience-usa.org
www.france-science.org


The Chateaubriand Fellowship program is designed for doctoral students enrolled in an American university who wish to achieve part of their doctoral research in a French laboratory for a period of 4 to 10 months. The Office of Science and Technology funds the compensation (1400€/month), travel expenses and health insurance.
Priority will be given to candidates who seek to establish a joint direction of their thesis with a French host university. All fields of Science, Technology and Health are eligible. The required level of French remains at the discretion of the host laboratory.
The deadline for applications is February 1st 2012, for a stay which can begin from September 1st 2011 to April 1st, 2013.
More information and registration:

http://www.chateaubriand-fellowship.org

Research Reporting Guidelines

This link: http://www.equator-network.org/resource-centre/library-of-health-research-reporting/ appears on the home page of our blog and points to the Equator Network library of research publication guidelines, including the CONSORT for randomized trials and its cousins.

Clinical Research Oriented Workshop (CROW) Meeting: December 22, 2011

Present: Ben Littenberg, Charlie MacLean, Connie van Eeghen

Guest: Tim Burdick, MD

1. Start Up: The effect of provider attitude on patient care encounters, especially motivational interviewing.

2. Rodger: Web-Based Self-Management Intervention for Multi-Morbidity R01, with co-PIs of Rodger and a colleague with much R01 experience. This grant has been under discussion for two years as the result of a conference not about collaborative care but health behavior interventions in medical disease.

a. NIH interest, through the Heart, Lung, Blood Institute. T his announcement came out in November regarding primary care patient with multi-morbid conditions, including mental health and substance abuse disorders. There was interest in alternative study methods to RCTs, including quasi-experimental design. The R01 announcement specifically calls for the development of an intervention. This application will be sent to the Dissemination and Implementation review session.

b. Progress on methods: The Oregon Research Institute has developed a track record and a web based tool, “MyPath,” a health risk appraisal with scoring/ranking and EBP patient support resulting in a plan with possible strategies and automated interventions (electronic reminders, journaling). Rodger has developed a positive working relationship with this Institute, proposing that bi-directional data sharing with provider based EHRs is an important addition. This study proposed to study MyPlan with depression, interaction with the EHR, and applying it in two models (dyadic primary care and collaborative care). (John Wasson at Dartmouth has done work with a health risk appraisal, barrier assessment, and visit planner print out for next appointment, accessible by patient and provider.) LOI needed followed by live presentation on January 4 (audio-visual web conferencing). Decision to be made about a week later.

c. In-depth discussion followed on us of the following design alternatives:

i. Usual care (no MyPath), all with EHR for a period of time

1. Patient portal exists and used

2. Behavioral health management application, with increasing use by patients over time (a threat to validity to be addressed by side analysis)

ii. MyPath in a traditional practice

iii. MyPath in a collaborative care BHC supported practice (pre-existing “patient centered behavioral health” aka PCBH)

iv. MyChart – the EPIC portal

1. with PCBH

2. without PCBH

v. Collaborative care with no MyPath (pre-existing PCBH)

1. studying ii and iii doesn’t prove anything about MyPath

2. studying i and ii looks at MyPath but doesn’t provide the “live coach” that Rodger is interested in

3. studying i and iii might show the highest impact but have the least explanatory ability

4. studying i and v, offering them both MyPath looks at all possible alternatives and needs the most number of practices (~300 per arm)

vi. Proposed design: study i and ii and iii, measuring by reaim

1. Reach: sign-ons created (may be contaminated by usual care patients with access to other patient portals)

2. Effective: PHQ-9, ER utilization

a. Measures: QUALI and composite measure

i. Euroqol 6D (how to obtain from usual care group, at least a sample; not obtainable from the experimental group who don’t access the portal)

ii. Better to use EHR based measures

1. ER utilization

3. Adapt: qualitative methods

4. Implement: qualitative methods – is this what NIH cares about most?

5. Maintenance: utilization of portal

vii. Recommendation: consider three arms and focus on what primary outcomes are

d. Process for exceeding the $500K cap (we didn’t get to this point, but it sounds interesting)

3. Next Workshop Meeting(s): Thursday, 12:30 p.m. – 2:00 p.m., at Given Courtyard Level 4

a. Dec 29: UVM closed

b. Jan 5: Journal Club; start new meeting time from 1:00 – 2:30 on Thursdays

c. Future agenda to consider:

i. Ben: budgeting exercise for grant applications

ii. Rodger: Mixed methods article; article on Behavior’s Influence on Medical Conditions (unpublished); drug company funding

iii. Amanda: presentation and interpretation of data in articles

iv. Future: Review of different types of journal articles (lit review, case study, original article, letter to editor…), when each is appropriate, tips on planning/writing (Abby)

Recorder: C. van Eeghen